A Memorandum Opinion And The Methods That Aren't There At All

You'd think that courts would be leery about dressing their Daubert gatekeeping opinions in the "differential etiology method". After all, as you can see for yourself by running the query on PubMed, the U.S. National Library of Medicine / National Institute of Health's massive database of scientific literature, apparently nobody has ever published a scientific paper containing the phrase "differential etiology method". Of the mere 22 articles ever to contain the sub-phrase "differential etiology" none use it in the sense - to rule in a heretofore unknown cause - meant by the most recent court to don its invisible raiment. Even mighty Google Scholar can manage to locate only 6 references to the "method" and all are law review articles resting not upon some explication and assessment of a scientific method known as differential etiology but rather on the courtroom assertions of paid experts who claimed to have used it.

You'd also hope courts would understand that scientific evidence is no different than any other kind of evidence. It must be still something that has been observed or detected albeit with techniques (e.g. nuclear magnetic resonance spectroscopy) or via analyses (e.g. epidemiology) beyond the ken of laymen. Yet, while they'd never allow into evidence (say in an automobile case) the testimony of someone who had witnessed neither the accident nor the driving habits of the Defendant but who was prepared to testify that he thought the Defendant was speeding at the time of the accident because Defendant looks like the sort of person would would speed and because he can't think of any other reason for the wreck to have occurred, some courts will allow that very sort of testimony so long it comes from a PhD or an M.D. who has used the "weight of the evidence method". Can you guess how many references to scientific papers using the "weight of the evidence method" PubMed yields? The same 0 as the "differential etiology method".

Nevertheless another (memorandum) opinion has joined the embarrassing procession of legal analyses bedecked in these ethereal methods; this time it's a radiation case styled  McMunn v. Babcock & Wilcox Power Generation Group, Inc. 

Plaintiffs suffering from a wide variety of cancers allegedly caused by releases of alpha particle emitting processed uranium from the Apollo, PA research and uranium fuel production facility sued Babcock and other operators of the site. Following battles over a Lone Pine order and extensive discovery the sides fired off motions to exclude each others' experts. The magistrate to whom the matter had been referred recommended that plaintiffs' general causation expert Dr. Howard Hu, specific causation expert Dr. James Melius, emissions and regulations expert Bernd Franke and nuclear safety standards expert Joseph Ring PhD be excluded. The plaintiffs filed objections to the magistrate's recommendations, the parties filed their briefs and the District Court rejected the magistrates recommendations and denied defendants' motions.

Dr. Hu had reasoned that since 1) ionizing radiation has been associated with lots of different kinds of cancer; 2) alpha particles ionize; and 3) IARC says alpha particles cause cancer it makes sense that the allegedly emitted alpha particles could cause any sort of cancer a plaintiff happened to come down with. It's not bad as hunches go though it's almost certainly the product of dogma -specifically the linear no-threshold dose model - rather than the wondering and questioning that so often leads to real scientific discoveries. But whether a hunch is the product of the paradigm you're trapped in or the "what ifs" of day dreaming it remains just that until it's tested. Unfortunately for Dr. Hu's hunch, it has been tested.

Thorotrast (containing thorium - one of the alpha emitters processed at the Apollo facility) was an X-ray contrast medium that was directly injected into numerous people over the course of decades. High levels of radon could be detected in the exhaled breath of those patients . So if Dr. Hu's hunch is correct you'd expect those patients to be at high risk for all sorts of cancer? They're not. They get liver cancer overwhelmingly and have a five fold increase in blood cancer risk but they're not at increased risk for lung cancer or the other big killers. Why? It's not clear though the fact that alpha particles can't penetrate paper or even skin suggests one reason. Look for yourself and you'll find no evidence (by which we mean that the result predicted by the hunch has actually been observed) to support the theory that alpha particles can cause all, most or even a significant fraction of the spectrum of malignancies whether they're eaten, injected or inhaled and whether at home or at work. Be sure to check out the studies of uranium miners.

But let's assume that alpha particles can produce the entire spectrum of malignancies, that the emissions from the facility into the community were sufficiently high, and that the citizenry managed to ingest the particles. What would you expect the cancer incidence to be for that community? Probably not what repeated epidemiological studies demonstrating that "living in municipalities near the former Apollo-Parks nuclear facilities is not associated with an increase in cancer occurrence" concluded.

Dr. Hu attacked the studies of uranium miners and of the communities around Apollo by pointing out their limitations. This one didn't have good dose information and that one had inadequate population data. Perfectly reasonable. It's like saying "I think you were looking through the wrong end of the telescope" or "I think you had it pointed in the wrong direction". He's saying "your evidence doesn't refute my hunch because your methods didn't test it in the first place."

Ok, but where's Dr. Hu's evidence? It's in his mind. His hunch is his evidence; and it's his only evidence. He weighed some unstated portion of what is known or suspected about alpha particles and cancer in the scales of his personal judgment and reported that CLANG! the result of his experiment was that the scale came down solidly on the side of causation for all of plaintiffs' cancers.

At the core of the real scientific method is the idea that anyone with enough time and money can attempt to reproduce a scientist's evidence; which is to say what he observed using the methods he employed. Since no one has access to Dr. Hu's observations and methods other than Dr. Hu his hunch is not science. Furthermore, there's no way to assess to what extent the heuristics that bias human decision-making impacted the "weighing it in my mind" approach of Dr. Hu.

Given that there's no way to reproduce Dr. Hu's experiment and given that none of the reproducible studies of people exposed to alpha particles demonstrate that they're at risk of developing the whole gamut of cancer Dr. Hu's argument boils down to that of the great Chico Marx: "Who are you going to believe, me or your own eyes?" Alas, the court believed Chico and held that "Dr. Hu's opinions have met the pedestrian standards required for reliability and fit, as they are based on scientifically sound methods and procedures, as opposed to 'subjective belief or unsupported speculation'".

Next, having already allowed plaintiffs to bootstrap alpha emitters into the set of possible causes of all of the plaintiffs' cancers, the court had no problem letting letting the specific causation expert, Dr. Melius, conclude that alpha emitters were the specific cause of each plaintiff's cancer merely because he couldn't think of any other cause that was more likely. At first that might seem sensible. It's anything but.

Don't you have to know how likely it is that the alpha emitters were the cause before you decide if some other factor is more likely? Obviously. And where does likelihood/risk information come from? Epidemiological studies in which dose is estimated. Of course the plaintiffs don't have any such studies (at least none that support their claim against alpha emitters) but couldn't they at least use the data for ionizing from say the atomic bomb or Chernobyl accident survivors? After all, the court decided to allow plaintiffs' experts to testify that "radiation is radiation".

Well, just giving a nod to those studies raises the embarrassing issue of dose and the one lesson we know plaintiffs' counsel have learned over the last several years of low-dose exposure cases is to never, ever, ever estimate a dose range unless they're ordered to do so. That's because dose is a measurement that can be assessed for accuracy and used to estimate likelihood of causation. Estimating a dose thus opens an avenue for cross examination but more devastatingly the argument that runs: "Plaintiff's own estimate places him in that category in which no excess risk has ever been detected."

Fortunately for plaintiffs the court held that Dr. Melius' differential diagnosis or differential etiology method does not require that he estimate the likelihood that radiation caused a particular cancer before he can conclude that radiation is the most likely cause among many (including those unknown).

First the court held that it was not its job to decide which method is the best among multiple methods so long as the method is reliable. For this it relies upon In re TMI Litigation. When In re TMI Litigation was decided (1999) the Nobel Prize in Physiology or Medicine for the discovery that Helicobacter pylori and not stress was the cause of most peptic ulcers was six years in the future. The method of observational epidemiology and application of the Hill causal criteria had generated the conclusion that peptic ulcers were caused by stress. The method of experimentation, observation and application of Koch's postulates established H. pylori (nee C. pyloridis) as the real cause; and, for the umpteenth time, experimentation as the best method. So could a court allow a jury to decide that the peptic ulcer in a plaintiff with a H. pylori infection was caused by stress at work? Apparently the answer is "Yes"; scientific knowledge be damned.

Second, citing In re Paoli and other Third Circuit cases, the court held that differential etiology (without knowledge of dose) has repeatedly been found to be a reliable method of determining causation in toxic tort cases. As we've written repeatedly this a claim wholly without support in the scientific literature. Are there studies of the reliability of differential diagnoses made by radiologists? You bet (here for example). Are there studies of immunohistochemical staining for the purpose differential diagnosis in the case of suspected mesothelioma? Yep. Here's a recent example. There are (as of today) 236,063 pages of citations to articles about differential diagnosis on PubMed and none of them (at least none I could find via key word searches) suggests that a methodology such as Dr. Melius' exists (outside the courtroom) and none represent an attempt to test the method to see if it is reliable.

Third, the court held that since Dr. Melius' opinions were the result of his "qualitative analysis" the fact that plaintiffs were living in proximity to the facility during the times of the alleged radiation releases and the fact that Babcock failed to monitor emissions and estimate process losses to the environment was enough to allow a jury to reasonably infer that plaintiffs were "regularly and frequently exposed to a substantial, though unquantifiable dose of iodized [ionized?] radiation emitted from the Apollo facility." How such reasoning can be anything other than argumentum ad ignorantiam is beyond our ability to understand.

Worse yet is this sentence appearing after the discussion about the absence of data: "A quantitative dose calculation, therefore, may in fact be far more speculative than a qualitative analysis." What would Galileo ("Measure what is measurable, and make measurable what is not so") the father of modern science make of that?  Yes an estimate could be wrong and a guess could be right but the scientist who comes up with an estimate makes plain for all to see her premises, facts, measurements, references and calculations whereas the expert peddling qualitative analyses hides his speculation behind his authority. Besides, dose is the only way to estimate the likelihood of causation when there are multiple, including unknown, alternate causes. Then again, in addition to everything else Galileo also proved that questioning authority can land you in hot water so we'll leave it at that.

Finally, in the last and lowest of the low hurdles set up for Dr. Melius, the court found that he had "adequately addressed other possible cause of Plaintiffs' cancers, both known and unknown." How? By taking looking for "any risk factor that would, on its own, account for Plaintiffs' cancers", reviewing medical records, questionnaires, depositions, work histories and interviewing a number of plaintiffs. Presumably this means he looked for rare things like angiosarcoma of the liver in a vinyl chloride monomer worker and mesothelioma in an insulator, commoner things like lung cancer in heavy smokers and liver cancer in hepatitis C carriers, and hereditary cancers (5% to 10% of all cancers) like acute lymphoblastic leukemia in people with Down syndrome or soft tissue sarcomas in kids with Li-Fraumeni Syndrome. You can make a long list of such cancers but they represent perhaps one fourth of all cases. Of those cancers that remain there will be no known risk factors so that once you're allowed to rule in alpha emitters as a possible cause ("radiation is radiation") and to then infer from both "qualitative analysis" and the absence of data that a "substantial" exposure occurred you've cleared the substantial factor causation hurdle (which at this point is just a pattern in the courtroom flooring). Having gotten to the jury all that remains is to make the argument plaintiffs' counsel made before Daubert: "X is a carcinogen, Plaintiff was exposed to X, Plaintiff got cancer; you know what to do."

We're living through an age not unlike Galileo's. People are questioning things we thought we knew and discovering that much of what the Grand Poohbahs have been telling us is false. There's the Reproducibility Project: Psychology the genesis of which included the discovery of a widespread "culture of 'verification bias'" (h/t ErrorStatistics) among researchers and their practices and methodologies that "inevitably tends to confirm the researcher's research hypotheses, and essentially render the hypotheses immune to the facts...". In the biomedical sciences only 6 of 53 papers deemed to be "landmark studies" in the fields of hematology and oncology could be reproduced, "a shocking result" to those engaged in finding the molecular drivers of cancer.

Calls to reform the "entrenched culture" are widespread and growing. Take for instance this recent piece in Nature by Regina Nuzzo in which one aspect of those reforms is discussed:

It would have to change how statistics is taught, how data analysis is done and how results are reported and interpreted. But at least researchers are admitting that they have a problem, says (Steven) Goodman [physician and statistician at Stanford]. "The wake-up call is that so many of our published findings are not true."

How did we get here? A tiny fraction of the bad science is the result of outright fraud. Of the rest some is due to the natural human tendency to unquestioningly accept, and overweigh the import of, any evidence that supports our beliefs while hypercritically questioning and minimizing any that undercuts it (here's an excellent paper on the phenomenon). Thanks to ever greater computing power it's becoming easier by the day to "squint just a little bit harder" until you discover the evidence you were looking for. For evidence that some researchers are using data analysis to "push" until they find something to support their beliefs and then immediately proclaim it read: "The life of p: 'Just significant' results are on the rise." For evidence that it's easy to find a mountain of statistical associations in almost any large data set (whereafter you grab just the ones that make you look smart) visit ButlerScientifics which promises to generate 10,000 statistical relationships per minute from your data. Their motto, inadvertently we assume, makes our case: "Sooner than later, your future discovery will pop up."

Of the remaining bad science, i.e. that not due to fraud or cognitive biases, apparently a lot of it arises because researchers often misunderstand the very methods they use to draw conclusions from data. For example, read "Robust misinterpretation of confidence intervals" and you'll get the point:

In this study, 120 researchers and 442 students - all in the field of psychology - were asked to assess the truth value of six particular statements involving different interpretations of a CI (confidence interval). Although all six statements were false, both researchers and students endorsed, on average more than three statements, indicating a gross misunderstanding of CIs. Self-declared experience with statistics was not related to researchers' performance, and, even more surprisingly, researchers hardly outperformed the students, even though the students had not received any education on statistical inference whatsoever.

We suppose such results would have surprised us before we got out of law school. Nowadays we just nod in agreement; our skepticism regarding the pronouncements of noted scientific authorities becoming complete after recently deposing an epidemiologist/causation expert who didn't even know what "central tendency" meant. He also had never heard of "The Ecological Fallacy" which explains why he committed the error throughout his report. He couldn't estimate how likely it was that the chemical in question was causative nor did he know the rate of the disease in plaintiff's age/gender bracket. No matter. His opinions came wrapped in the same non-existent scientific methods and the court has been duly impressed with his extensive credentials and service on panels at NCI, IARC, etc. So it goes. 

Hopefully courts will begin to take notice of the rot that sets in when scientists substitute personal judgment, distorted by cognitive biases to which they are blind and intuitions which can easily lead their causal inferences astray, for measurement and experiment in their quest to generate scientific knowledge. That and the fact that the method some experts parade about in are not in fact a way of doing science but rather just a way of shielding their unscientific opinions from scrutiny.

Too bad about the method though. If it worked we could hire the appropriate scientific authorities to come up with a cure for cancer. They would ponder the matter, render their opinions as to the cure and testify as to why their "qualitative analysis" which points to the cure is obviously the correct one. The jury would pick the best treatment among those on offer and the court would enter a judgment whereby cancer was ordered to yield to the cure. That's not how it works and it wasn't how it worked in the early 1600s when the sun refused to revolve about the earth, heedless of the pronouncements of scientific authorities and courts of the day. Maybe history will repeat itself in full and scientific knowledge, the product of observation, measurement, hypothesis and experiment will again mean just that and not the musings of "experts" bearing resumes and personal biases rather than facts. Maybe if we're lucky the rot will be cut out and the tide will finally turn in the long war on cancer. We'll see.

The West Virginia Supreme Court of Appeals Doesn't Get The Scientific Method

Milward v. Acuity has spawned another troubling anti-science opinion: Harris v. CSX Transportation, Inc. Whereas Milward held that credentialed wise men should be allowed to testify that an effect that has never been observed (indeed one that could not be detected by any analytical method known to man) actually exists, Harris holds that such seers may further testify that an effect that would be observable (if it existed) and which has been repeatedly sought in the wake of its putative cause yet invariably not observed actually exists nonetheless.

How are plaintiffs pulling it off? By convincing some judges that testing, the essence of the scientific method, need not be done in laboratories and need not be independently reproducible. These courts have decided that biomedical discoveries can reliably be made, at least in the courtroom, merely by having an expert witness test in his mind a suggested causal association by running it through whatever causal criteria he thinks appropriate and weighing the resulting evidence according to his subjective judgment. Really, it's that bad. Two courts have now granted paid-for hypotheses a status equal to or higher than (depending on the jury's verdict) that of scientific knowledge (conjectures that have been severely and repeatedly tested and have repeatedly passed the tests). Now, we could point out that hypotheses generated by the process endorsed by these courts pan out perhaps 1 time in 100  - i.e. the method's rate of error is 99% - and so flunks a key Daubert factor, but that ignores the real ugliness here - an attack on the scientific method itself.

It has been said that the point of the scientific method is to let Nature speak for herself. By observing, measuring and recording scientists listen to her. By generating hypotheses about the order in which the observations occurred they attempt to make sense of what she's saying. By testing their hypotheses (i.e. by attempting to reproduce the observed effect in a controlled setting) scientists ask if they've misunderstood her. By publishing their results scientists communicate what they've learned and invite others to try to reproduce and build upon it. This method of objectively assessing a phenomenon, guessing at what it implies about how the world works, testing that guess and then reporting the results along with the method, materials and measurements involved ushered in the world we know today. It also dislodged those who in the past had sought to speak for Nature; those whose power and place had been derived from their ability to explain the world by way of plausible and compelling stories that served some narrative. They were dislodged first because the scientific method proved a better lodestone and second because the method, once applied to ourselves, revealed human intuition and judgment to be woefully prone to bias, fear, superstition and prejudice.  

Luckily for the would-be oracles who made their living as expert witnesses it took a long time and extreme abuse of the word "scientific" before the law came to terms with the scientific method. Finally Daubert accepted the central tenet of the scientific method - i.e. that to be scientific a theory must be testable - and thus necessarily accepted that the law could not lead science as it was obviously unequipped and ill-suited for testing theories. The law would have to follow science.  Other opinions refined the arrangement until we got to where we are today (at least where we are in Texas). Now an expert's opinion must be founded on scientific knowledge and may not reach beyond what can reasonably be inferred from it (i.e. the analytical gap between what is known and what follows from that knowledge doesn't require much of a leap - it's really just a matter of deduction). A case that's kept us busy the last month provides an example.

The plaintiffs' decedent had died of acute myelogenous leukemia (AML) and his family blamed benzene exposure. The battle was fought not over whether benzene can cause AML (though there are some interesting arguments to be made on the subject) but rather over whether plaintiff was exposed to enough and whether the risk posed by the exposure was considerable. The experts did have some leeway on issues like retrospective exposure estimation and whether the latency period was too long as on both sides there were scientific studies demonstrating the effect in question. Yet in the main the experts' opinions mostly overlapped; differing only according to the testimony of the fact witnesses on which their side relied. The jury thus was to decide which of two competing pictures of plaintiff's workplace made the most sense and not whether benzene causes AML. Surely that's the sort of case for which trial by jury was designed.

However, many still chafe against Nature's tyranny and argue for the old ways; for human judgment unconstrained by measurement, testing and thus the embarrassing possibility (likelihood, actually) of having their beliefs publicly refuted. So some argue that Nature is too coy and that she refuses to reveal what they're sure must be true. Others just don't like what she has to say. And of course there's the whole financial angle given that a lot more lawsuits could be filed and won if Nature could be made to speak on command or if the subjective judgment of experts could be re-elevated to the status of pronouncements by Nature.

So what to do? One solution is to adopt the "if you can't beat 'em, join 'em" motto" and bank on the truism that "if you can't find a way to generate a statistically significant association between an effect and what you suspect is its cause then you're too stupid to be a scientist." But that plan first ran afoul of the courts when it was recognized that, for example, improper epidemiological methodology had been employed to generate the results (see e.g. Merrell Dow v. Havner) and more recently as it has become evident that there's a crisis in the biomedical sciences - that many if not most statistically significant results cannot be reproduced and it's because many and probably most reported findings involving small effects (generally an increased risk of 3-fold or less) are false.

What to do, what to do? You need a method a court will say is valid and you need a test that can't be mathematically demonstrated to generally produce bad results and that also can't be run by someone else (lest she falsify your theory and ruin all the fun). What about equating a decision-theory process like weighing the evidence or applying the so-called A. Bradford Hill "criteria" to say significance testing of statistical inferences (e.g. epidemiology) or to fluorescent labeling of macromolecules for quantitative analysis of biochemical reactions? Now you're on to something! Because the weights assigned to bits of scientific evidence are necessarily matters of judgment experts can now "test" their own theories by weighing the evidence in the scales of their own judgment. And any theory that passes this "test" gets to be called "scientific knowledge" and, best of all, can never be refuted. A jury can then decide which of two competing pictures of say the anthrax disease propagation process (e.g. miasma vs germ theory) is the correct one. Robert Koch would be appalled but the Harris court bought it.

The decedent in Harris worked for a railroad and claimed his multiple myeloma (MM) had been caused by exposure to diesel fumes. The problem was that every epidemiological study of railroad workers, i.e. every known test of the potential relationship between working for a railroad and MM, failed to show that MM was associated with railroad work. In fact, every study designed specifically to test the theory that MM follows diesel exhaust exposure by railroad workers has failed to demonstrate an association, much less causation. Plaintiff tried to reframe the question by saying there's benzene in diesel exhaust smoke and that benzene has been associated with MM but the problem was that there's benzene in cigarette smoke too; far more in fact than in diesel smoke, and yet MM risk is not increased with cigarette smoking. Plaintiff then re-reframed the question by arguing that some molecules found in diesel exhaust had been associated with cancer (lung) and "oh, by the way," some of the chromosomal changes found in Mr. Harris' pathology were sometimes seen in people (with a different disease) exposed to benzene. In sum, there was no evidence drawn from observations of the world, i.e. the scientific method to demonstrate that diesel exhaust was a cause of MM in railroad workers; and the trial court excluded the experts' opinions.

On appeal the West Virginia Supreme Court of Appeals latched onto the following quote from Milward which I'll break into its three component sentences:

1) "The fact that the role of judgment in the weight of the evidence approach is more readily apparent than it is in other methodologies does not mean that the approach is any less scientific."

This is where the need for independently verifiable testing is deleted from the scientific method.

2) "No matter what methodology is used, an evaluation of data and scientific evidence to determine whether an inference of causation is appropriate requires judgment and interpretation."

This is where the need for a theory to have passed a serious test; i.e. that the effect has been observed to actually follow the putative cause in an experiment or retrospective epidemiological study, is eliminated as a requirement for a theory to constitute "scientific knowledge."

3) "The use of judgment in the weight of the evidence methodology is similar to that in differential diagnosis, which we have repeatedly found to be a reliable method of medical diagnosis."

This is the punch line. A method for ruling out known diseases to infer the one from which a patient is actually suffering is transformed into a way to rule in by human judgment heretofore unknown causes of that disease without any objective evidence that, to paraphrase Hume, whenever the putative cause occurred the effect has routinely been observed to follow.

Given the foregoing as the court's (mis)understanding of the scientific method it should come as no surprise that it concluded "the experts in the instant case did not offer new or novel methodologies. The epidemiological, toxicological, weight of the evidence and Bradford Hill methodologies they used are recognized and highly respected in the scientific community." The effort to conflate statistical hypothesis testing and pharmacokinetic assays with subjective human judgment was complete and the trial court's ruling was reversed.

So now, in West Virginia, it's enough for an expert to say in response to the question: Has your hypothesis been tested? "Yes, I have weighed the data that gave rise to the hunch in my brain pan and I can now report that it convincingly passed that test and may reliably be considered 'scientific knowledge'". Ugh.

Bostic Oral Argument: Plaintiffs Play A Clever Tune

Notwithstanding the briefs of Georgia-Pacific and numerous amici, appellant Bostic, appellee Georgia-Pacific and (seemingly) most of the justices appeared by the end of oral argument on Monday to reach at least partial agreement on the big issue. Specifically, that somehow or another it ought not be the law when multiple defendants create conditions each independently capable of causing plaintiff's injury that none of them be held liable merely because it would be impossible for plaintiff to prove that any one of them was the "but for" cause of her injury. It wasn't exactly a Kumbaya moment but it was close. And the refrain was of Ford v. Boomer and of Merrell Dow v. Havner; and it made us very worried about the future of one of the most important defense victories ever - Borg-Warner v. Flores.

Until the last third of the proceedings a sensible guess as to which way things might go was hard to come by. Much of the briefing and a fair bit of the argument was hopelessly confused due to the tendency of the various parties to attribute decidedly different meanings to identical causal language. It's hardly the fault of the attorneys. Most causal distinctions made in legal opinions still consist, however solemnly invoked, of little more than "moonshine and vapor" (see "Proximate Cause in California" by William L. Prosser, 1950 - a really fun paper btw). Maybe the court in whatever opinion it authors will adopt a modern lexicon of causality with readily translatable and transportable ideas like "necessary cause" and "sufficient cause". We can only hope. But in any event Bostic's counsel cleverly suggested a compromise, the Davidson rule with a little Havner on top, and suddenly, alarmingly, everyone seemed in agreement.

The Davidson rule, like that of Ford v. Boomer, settles the question of where to draw the line for the outer limit of liability for asbestos-related disease by requiring that plaintiff's exposure from any potentially liable defendant's product (or premises) be in and of itself sufficient to have caused the disease. In Texas (see Havner) that would mean given the current state of uncertainty about the causal mechanisms underlying asbestos exposure and mesothelioma that plaintiff would have to show whatever exposure she attributes to a particular defendant doubled her risk of developing mesothelioma. Any defendant whose contribution could be shown to satisfy the risk doubling requirement would have to face a jury; and any defendant whose contribution did not double the risk could have its summary judgment and go home. Seems fair; what's not to like?

Plenty. Remember that causation is necessary but not sufficient for the determination of substantial factor causation. It is not enough for legal causation to show that grabbing a stumbling passenger's arm dislodged a plain brown package containing fireworks that fell to the ground, exploded and caused some distance away a scale to bonk Mrs. Palsgraf on the head.  The risk posed by the act of grabbing the stumbling passenger's arm must have been of such a degree as to generate a duty for the ordinarily prudent railroad employee to have done something different. Unless we missed it, not once during oral argument did anyone utter "legal cause" or "de minimis risk". Why? We suspect it's not because everyone forgot that the substantial factor test of legal causation requires causation plus a non-de minimis risk but rather because everyone assumes a 100% risk increase must be substantial - an all too common consequence of our cognitive blind spot for percentages.

Something that increases the risk of mesothelioma by 100% hardly sounds de minimis. But think about it this way, your odds, absent asbestos exposure, of developing mesothelioma are 1:1,000,000 (one in a million). Doubling the risk increases the odds to 1:500,000. Those are your odds of being struck by lightning this year according to National Weather Service estimates. And that risk is tiny compared to your risk of having say the wind drop a tree limb on your head.

So should a 1:500,000 risk be big enough for the imposition of a duty? That's for the courts to decide by way of public policy analysis but they ought to go into the exercise understanding what it would mean to say that someone who creates a 1:500,000 risk of death can be subject to liability and even punitive damages. Consider these examples of activities that increase the risk of death by 1:500,000: two days of snow skiing, going horseback riding 4 times or eating one peanut butter and jelly sandwich per year (aflatoxin). If that doesn't make the point consider this: 1:500,000 odds are less than those of flipping a fair coin 18 times and having it come up heads every time.

So here's to hoping the court keeps in mind that whether or not a duty should be imposed in a given case is gauged by whether the defendant has created a substantial risk and not whether a risk has been altered substantially. Otherwise we'd wind up with the absurd conclusion that doubling an infinitesimal risk creates a substantial one.

P.S. If you're interested in how the counterfactual or "but for" view of causation survives a multiple sufficient causes problem like that seen in Bostic see chapter 10 of Judea Pearl's book "Causality".

Alas, The Maryland Court of Appeals Has Reversed Ford v. Dixon

Sound science and, more importantly, sound reasoning about science have slowly been making their way into appellate decisions for two decades now, but last year's Ford v. Dixon was something special. We called it the best causation opinion of 2012 and without saying so thought it a Palsgraf for this age of Big Data. Acknowledging the data available for estimating a given asbestos exposure and the risk attendant to that exposure the opinion simply asked of plaintiffs that they 1) demonstrate that the risk complained of is not merely de minimis; and, 2) explain how they estimated the risk.

The opinion recognized the centrality of risk in so-called substantial factor causation analysis. It also held that establishing the existence of an infinitesimal risk cannot suffice to carry plaintiff's burden of showing a substantial one. Finally it required that plaintiff estimate the risk by reasonable inference drawn from sound quantitative science. Essentially it replaced crude (and easily distorted) proxies for risk like Lohrmann's frequency, proximity and regularity test (now more than a quarter century old) with a modern approach based on the data and the statistical inferences that it warrants. Its analysis was, as the dissent in last week's opinion stated, excellent.

But it didn't reflect the law in Maryland according to the state's highest court (Dixon v. Ford). Reciting that it had held as recently as 2011 that the "'frequency, regularity, and proximity' test remains 'the common law evidentiary standard used  for establishing substantial-factor causation in negligence cases alleging asbestos exposure'", and that a decade before that it had declined to hold that a plaintiff must "present expert testimony as to the amount of respirable asbestos fibers emitted by a particular product", the court found that the plaintiff had satisfied her burden by showing that her husband had done 1,000 brake jobs and by her expert's conclusion that the resulting in-home exposures were "high" and so "a substantial factor" in the cause of her mesothelioma.

Apparently Ford's main argument was that plaintiff's expert had hung her hat on the dubious "every fiber / every breath" theory. The court found that argument disingenuous as the evidence established years of work on asbestos-containing brakes and routine contamination of the home from the clothing of plaintiff's husband. Ford's better argument (described by the court as "a fallback"), was that the failure (or more likely refusal) of plaintiff's expert to estimate the risk from such exposures meant that the question of whether the exposures were a substantial factor (i.e. "but for" cause plus a not insubstantial risk) went unanswered. So the testimony, lacking any information about risk, could not possibly assist a fact finder to determine whether the risk was substantial. The only answer the court could muster to this objection was that they already had a substantial factor test - the frequency, proximity and regularity test; and it was satisfied by evidence of an asbestos-related disease, 1,000 brake jobs and an exposure opined to be "high".

Ironically the court then went on to render many more pixels in a discussion of the Dixon plaintiffs' damages. Imagine what would happen if a plaintiff were to try to hold an award for lost wages when his evidence consisted only of the following: a) "I planned to keep working"; b) "I worked six days a week"; and, c) "I was a very hard worker." Without some numbers behind these statements no jury could sensibly answer a binary question like "Has she lost more than $50,000?" much less "How much has she lost?" And even if an economist showed up to support whatever sum plaintiff's counsel intended to blackboard/whiteboard/PPT/etc no court would let him testify unless he could at least opine about the incomes of people who have jobs like the plaintiff's.

So why in a time when when it's easy to find data about the asbestos exposures of people who had jobs like the plaintiff's don't we demand that experts say what they are? And why in a time when it's easy to estimate the risk posed by a given exposure don't we demand that experts say what it is? We know why the plaintiffs don't want to have to quantify dose and risk in low dose cases - either the calculated risk is too small or it's too easy to call BS on the way it was calculated if it's high. But why so many courts continue to resist quantitative data on the question of substantial factor causation in asbestos cases remains to us a mystery; especially when there's so much data available.

In the end Ford v. Dixon sought to introduce the law to the sort of decision-making tools that are revolutionizing everything from medical diagnoses to weather forecasting in hopes of making justice a little less rough and a little more just. If it had a flaw it was that it was ahead of its time.

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Foreseeably Pointless

Georgia Pacific v. Farrar went up to the Maryland Court of Appeals on two issues. The first was whether in 1968 Georgia Pacific owed a duty to the granddaughter of a mechanic whose clothes were contaminated at work with asbestos due to the mixing and sanding of its product by nearby drywall workers (she was exposed to the dust when she washed his clothes and decades later she developed mesothelioma). It would require the court to decide what was generally known and knowable almost half a century ago and then what future a reasonable manufacturer of drywall compound would have foreseen given that knowledge. The second issue was whether such an exposure could be the legal cause of her injury. It would require the court to decide whether some risks are just too small. Alas for trial by jury and clarity, the court chose to decide the first issue and to avoid the second.

Things looked more hopeful early in the opinion when the court noted with approval its prior holding that duty is "the responsibility each of us bears to exercise due care to avoid unreasonable risks of harm to others." When the level of risk determines the existence of a duty the perfect case for drawing lines based on public policy consideration (ultimately the "core" of duty determination) is one like Farrar. Thanks to a vast amount of literature on the subjects the asbestos exposure (or dose) from a given activity can be reliably estimated and the resulting risk of mesothelioma can then in turn be reliably calculated. To get to the jury the plaintiff needs merely to demonstrate that her exposure was like others that have been measured and that such exposure (or dose) poses a risk that's "unreasonable". Of course that means a court would have to answer a question like "As a matter of public policy, will we subject to tort claims those who create a risk of death of less than 1 in 1,000,000?" Perhaps because the impact of such a decision, either way, would be too obvious the court chose instead to rummage about in its bag of duty-determining fudge factors in order to come at the question from a far less obvious angle.

In looking to see whether Georgia Pacific had a duty to warn the court began by re-recounting a "non-exclusive list of factors for balancing the policy considerations inherent in the determination of whether a duty exists". Those factors are: (1) the foreseeability of harm to the plaintiff, (2) the degree of certainty that the plaintiff suffered the injury, (3) the closeness of the connection between the defendant's conduct and the injury suffered, (4) the moral blame attached to the defendant's conduct, (5) the policy of preventing future harm, (6) the extent of the burden to the defendant and consequences to the community of imposing a duty to exercise care with resulting liability for breach, (7) the availability, cost and prevalence of insurance for the risk involved. To this it added (8) the nature of the harm likely to result from a failure to exercise due care and (9) the relationship between the parties. The last two don't actually go into the scales for the duty-determination weighing exercise but serve instead as "guideposts in that weighing process", which makes them sound more like thumbs but it's not our metaphor so we're not sure.

Anyway, it's a grab bag of dubious value. Take foreseeability. Do we wind up deep in the weeds of e.g. what warrants true knowledge (today and 45 years ago)? Or isn't this better left as a fact issue for the jury? And if it is, what to do about hindsight bias? Then there's "the degree of certainty that the plaintiff suffered the injury." Given the nonexistence of time machines why would our current degree of belief about a causal claim modify our view of how a reasonable man should have acted in the distant past? The "closeness" factor sounds like a fusion of both sides of the Palsgraf debate, the "moral blame" factor suspiciously value-laden, the burden/consequences factor positively Hand-ian, and the available, widespread and affordable insurance factor simply redistributionist. It's not a list of the aspects of a coherent theory of duty in tort law but rather a catalog of distinct and often competing theories. But that's neither here nor there as the court needed only the first factor, foreseeability, to decide the case.

Echoing the recent U.S. Supreme Court case of Mutual Pharmaceutical Co. v. Bartlett the Maryland court started its discussion by reaffirming the centrality of conduct, and thus duty, to strict liability jurisprudence. The court reasoned that requiring a product manufacturer to know more than the "generally recognized and prevailing scientific and technical knowledge available at the time of manufacture" would make it "absolutely labile - an insurer of the product's safety - and that is not the law." So duty survived strict liability and 402A; and if anything it was elevated. This was done by imposing a duty to know what was knowable.

But how do you decide what is known, particularly in the bio-medical sciences where some days black swans seem to outnumber white ones? Well, reasonable inference apparently isn't enough. Writing that "the danger of exposure to asbestos in the workplace was well-recognized at least by the 1930s, the danger from exposure in the household to asbestos dust brought home by workers, though in hindsight perhaps fairly inferable, was not made publicly clear until much later." The court here was referring to OSHA's 1972 adoption of rules designed to prevent "take-home" exposures - four years after Ms. Farrar's exposure.

So is the idea here that OSHA is first to know what is knowable in these matters? Or is it that a thing is not really known until OSHA proclaims it so? Fortunately at that very moment the opinion spots a previously unseen guidepost and suddenly swerves to avoid this doubtful course. It turns out that (9) has a subpart - (9)(a) feasibility. "To impose a duty that either cannot feasibly be implemented or, even if implemented, would have no practical effect would be poor public policy indeed." Turning then to the facts at hand the court concluded "[t]he simple fact is that, even if Georgia Pacific should have foreseen back in 1968-69 that individuals such as Ms. Farrar were in a zone of danger, there was no practical way that any warning given by it to any of the suggested intermediaries would or could have avoided that danger."

Foreseeability is thus modulated by feasibility so that in this case the lack of regulations pertaining to things like employer provided locker rooms, showers, protective clothing and safe laundering of work clothes made it impossible for Ms. Farrar's grandfather not to bring home dust. Furthermore, no means existed at the time that would have allowed the dissemination of whatever warning information plaintiff thought ought to have been included with the product to every person who might come into contact with a person who had come into contact with some who had worked with asbestos. (Note: doesn't this sound like a causation argument?). There being no point in a duty to do something pointless Georgia Pacific prevailed.

It was in our view the right result for the wrong reason. The risk of death posed by the exposures described, intermittent and light and had by a bystander's bystander is just a tiny fraction of the risk of death posed by bathtubs or showers. Wouldn't it be better to simply decide that there's some level where at which a risk becomes too small, too remote, to warrant the imposition of a duty to act? Wouldn't it be better to leave it to the jury to decide in those cases where risks are not merely de minimis whether as the voice of their community the risk was acceptable or too high? Draw the boundaries beyond which reasonable minds cannot differ and public policy cannot allow and leave what's inside to the jury and the advocates. They'll use the same fudge factors (save insurance) as 1 - 9(a) when weighing the arguments about breach and, if there's anything to The Wisdom of Crowds, more closely approximate justice in the bargain.

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Lawyers Have Learned To Distort Pharmacovigilance Signals

The goal of pharmacovigilance is to detect the subtle signal of a causal effect otherwise buried amongst the noise of all the maladies which by coincidence alone happened to manifest after a drug was taken. The FDA Adverse Event Reporting System (FAERS) gathers reports of these adverse events and presents them in a database that can be analyzed for just such signals. Since previously unknown causal associations are what are being sought there is no requirement that the reported adverse effect be demonstrably causal. To work properly the system merely requires accurate and unbiased reporting of as much adverse event data as possible.

You'd think health care professionals would be responsible for most of the reported adverse events and most of the time you'd be right. But zealous advocates (aka lawyers) can submit adverse reports too and when they do the resulting signal amplification is amazing (or appalling, depending on your perspective). Take the case of metoclopramide and tardive dyskinesia (TD) examined in:  "The Metoclopramide Black Box Warning for Tardive Dyskinesia: Effect on Clinical Practice, Adverse Event Reporting, and Prescription Drug Lawsuits".

For years the rate of TD per metoclopramide (Reglan) prescription bumped along at the bottom of the graph never rising above one half of one tenth of one percent. It is, or was, commonly prescribed in those suffering from gastroparesis. Then came a black box warning advising of the very rare but very serious side effect TD. Suddenly the TD rate took off like the Blue Angels at an airshow. What was behind it? "In the FAERS, only 3.6% of all the reports are from lawyers, whereas 70% of TD reports related to metoclopramide came from lawyers, resulting in a significant magnification of TD reports disproportionate to all other adverse reports." Interestingly, the authors using published legal opinions regarding TD/metoclopramide as a proxy for filings found that a wave of claims took off just before the wave of reports of TD. 

Distorting the metoclopramide/TD risk signal caused doctors and patients to overestimate the risk posed by metoclopramide. Often they chose instead domperidone which has not been approved by the FDA; unfortunately that "[puts] patients receiving this drug at potential risk for serious or even fatal arrhythmias."

Perhaps even more unsettling is the fact that as fewer and fewer prescriptions for metoclopramide were written the increase in the rate of TD got steeper and steeper. One hypothesis that readily emerges is that lawsuits drove the increase in TD cases rather than the other way around. If so, it points to another chronic problem in mass tort litigation - expert witnesses whose primary contribution is to dramatically over-diagnose ailments like TD.

The authors note that theirs is not the first study to find that lawyers are able to modulate the signals relied on for pharmacovigilance. It'll be interesting to see what if anything the FDA does about it.

But Generic Sulindac Isn't Bag O'Glass

The U.S. Supreme Court decided Mutual Pharmaceutical Co. v. Bartlett  this morning and it was another win for manufacturers of generic pharmaceuticals - once again thanks to "impossiblity preemption". The case had been appealed from the First Circuit which had held that strict liability schemes like New Hampshire’s (where the case originated) are about compensation and not regulation. Accordingly a generic drug manufacturer who complied with federal laws that specified a drug’s molecular structure and the warnings that go with it could still be subject to state tort liability schemes designed to redistribute losses caused by the drug so long as the manufacturer was free not to sell it in the first place.

Noting that New Hampshire’s courts have repeatedly declared that “liability without negligence is not liability without fault” the Supreme Court determined that New Hampshire law imposes a duty to design products, including drugs, so that their utility outweighs their risks and to “ameliorate” the risk-utility profile with warnings. Imposing duties which if breached trigger adverse consequences is obviously a form of regulating conduct and so the Court concluded that the First Circuit was simply wrong about the philosophy at the heart of New Hampshire’s strict liability jurisprudence (and put off for another day addressing the question of what to do if confronted with a state's pure redistribution / no-fault scheme).

 

Since the manufacturer could not simultaneously provide only the FDA-mandated warning and a different warning in New Hampshire, and because a molecule cannot be redesigned without turning it into something else, the Court determined that this case triggered “impossibility preemption” – a form of implied preemption. The Court held that in such cases an actor is not required to “cease acting altogether”. Instead, the state law is held to be “without effect”; falling to the Supremacy Clause. Mutual, having established that its product was as designed and carried the mandated warning, prevailed.

 

The dissenters tried to thread the needle but failed. They usually argue that state tort liability systems complement federal regulatory efforts but here needed to finesse the conflicting regulations problem. So, the FDA regulations were cast as mandates and New Hampshire’s tort laws as “incentives” so that it was not impossible for Mutual to comply with both because it was only required to comply with one, the federal, and was free to “exit the market” in New Hampshire or pay the price of doing business there. The idea is that states ought to be free to decide that some products (effectively) cannot be sold within their borders. From our perspective that argument only makes sense if you take the view that the FDA's approval of generic sulindac (the drug at issue) was akin to "Bag O'Glass" having been approved by the CPSC.

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A Duty To Mine Big Data

We had another jury trial and thus were offline for a few weeks but it didn't take long to dig up something I hope you'll find of interest. I ran across it in a recent opinion by the district court in the In Re Fosamax Product Liability Litigation. What is it? It's a duty to actively mine the FDA's data for a signal, a hint, that your approved pharmaceutical product might be associated with an adverse event.

As an initial matter I almost didn't get to the interesting part of In Re Fosamax Product Liability Litigation thanks to this eye-roller: "In applying the nine Bradford Hill factors, he [Dr. Cornell] reviewed Plaintiff's medical records from 1996 to present, the office notes and depositions of her treating physicians, and 'past and current medical literature on the topics of osteopenia, osteoporosis and their prevention and treatment with bisphosphonate drugs including alendronate'". Which was followed by: "The methodology Dr. Cornell used is sufficiently reliable because the Bradford Hill criteria are 'broadly accepted' in the scientific community 'for evaluating causation, and 'are so well established in epidemiological research". This business of giving expert witnesses a pass for doing nothing more than invoking the great epidemiologist's name and saying that their method consisted of peering at the evidence through the supposed lens of Hill's "criteria" is utterly appalling but it would take several paragraphs to explain and we've done it before so I'll leave it at that.

The portion worth pondering is found further down in the discussion of defendant's motion to exclude a different expert witness, Dr. Madigan. Madigan is a statistician from Columbia with an impressive resume. He was tasked with assessing "whether a signal of problematic oversuppression of bone turnover and associated [atypical femur fractures (AFF)] . . . existed for Fosamax, using industry standard pharmacovigilance techniques and data sources, and the adverse event terms selected by Merck to internally evaluate the same" and whether "the strength of that signal, if any, in comparison to the signal, if any, for such events in other products indicated for the prevention and treatment of osteoporosis". To identify and evaluate such a signal Madigan took several medical terms considered by the defendant to be possible indicators of "oversuppression of bone turnover" and/or AFF and, using a program called Qscan, ran them through FDA's Adverse Event Reporting System ("AERS") database looking for associations with Fosamax use.

The data revealed "the presence of a clear signal for oversuppression of bone turnover and associated atypical femur fracture events utilizing the terms selected by Merck for such analysis. By standard metrics of 'signal' detection, the signal is strong, consistent, and not ambiguous. Of perhaps greater concern, the signal was striking in comparison to that for other drugs indicated for the prevention and treatment of osteoporosis. As early as 2001-2002, the spontaneous report data for Fosamax provide signals for a number of indicators of suppression of bone turnover. For the comparator drugs, such signals either never appear or appear years later." As Qscan (or similar software) data mining is widely used (and often mandated in the pharmaceutical industry) and as peer-reviewed papers arising out of data generated by the software had been published the court concluded that "data mining in pharmacovigilance" is a reliable method. Fair enough.

The excitement comes in the next paragraph in which the court concludes that Madigan's testimony "fits", and so is relevant to, an issue in the case because it informs the question of whether the defendant should have warned of the later-perceived risk of AFF. The court thereby implicitly held, I think, that the defendant had a duty to mine the FDA's data as early as 2001-2002. In other words, the existence of powerful data mining tools capable of uncovering an early signal of a possible harm associated with defendant's product created a duty to use such a tool. Ultimately, that's a duty to discover any statistical association between your product and some harm in the FDA's (admittedly accessible) that might be causal and to thereafter warn about it; and it's a duty to mine not only your data but any data that might shed light on your product.

It's hard to know what to make of a duty to mine big data. Obviously it's a potential problem for defendants. "Should have known" is no longer what was reasonably knowable (by humans). Instead it's what was knowable given a duty to use "powerful data mining and signal detection capabilities" including "a powerful query-by-example module that allows users to mine and visualize data through inquiries utilizing multiple case data elements." We're already in the middle of something similar; a case in which the plaintiff is demanding to see all of the death certificates collected by our client's benefits department claiming that we had, or had assumed, a duty to look for mortality patterns among our workers that might suggest a work-related etiology - the idea being that the plaintiff's decedent had succumbed to one such workplace illness and we either knew or should have known from looking at the death certificates that danger had been lurking.

And of course there's the problem of experts coming in after the fact and running term after term after modified term in varying combinations until an association emerges. Working backwards they'll then construct a narrative about why the set of terms eventually founded to produce the association would have been the obvious choice at the time the data mining ought to have been done; and the failure to look for such an obvious potential association will thereafter be cast as willful ignorance.

Then there's the bane of defendants in all latent disease cases - the hindsight bias. It's the "knew it all along" fallacy that emerges when a jury is shown the picture on the box before they see the puzzle pieces inside. They can't thereafter imagine that the few anecdotes and case reports that constitute a handful of the pieces that make up the picture on the box could ever have suggested mere randomness. That means the ability to mine huge amounts of data will make signals easier to find while making it harder to mount a successful state-of-the-art defense any time Qscan can tease a signal from the data.

Data mining has led, and will lead to startling discoveries in the sciences. In the law it may well lead to startling liabilities - especially if defendants are made to pay for harms foreseeable only by the most powerful software available. Ponder that.

"FELA is a very favorable statute for railroad employees"

In fact, it is so favorable that the post hoc ergo propter hoc fallacy is enough to carry the day. Consider Clements v. Norfolk Southern.

Plaintiff, an employee of a railroad, either slipped off or fell off a tire. How he came to be on it is not made clear but the tire was four feet in diameter and off it he went. At trial he testified that prior to the accident he had been free of back pain but was afflicted by pain, and a herniated disk, thereafter. Though he had no expert willing to opine that his fall was the cause of his sore back the court held "[i]t is not beyond the province of an ordinary person that falling off a four foot high tire could cause a herniated disk."

While it has long been the case that "experts" can be found who are willing to testify that tying one's work boots will readily cause a herniated disk or that falling off the roof of a two story building can't possibly cause a herniated disk - and one side or the other of every scenario in between - courts ought not give up on the quest for sound science in such cases. That's because science, at long last, is starting to test various theories concerning the causes and appropriate treatment for herniated disks. So far, evidence-based assessments are giving the "province of an ordinary person" a thrashing.

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Is It Liability All The Way Down?

Back to the Burks problem from the last post.

Is there something wrong with shifting one element of plaintiff's burden of proof (defendant-specific "but for" causation in the case of alternative liability) to the defendants when nature may well have been, but probably wasn't, the cause of plaintiff's injury? The trial court in Burks didn't think so. After all, the rationale behind the decision in Summers v. Tice to engage in such burden shifting was that as between a defendant who committed a wrong, and an innocent and wronged plaintiff, the risk of loss ought to be borne by the wrongdoer. So why would it be necessary that all of those potentially responsible for the harm be present? After all, thanks to Summers the wrong (breach of a duty) has been decoupled from causation in the "wrong + 'but for' causation = legal causation" calculus.

Thus, if the defendants each breached a duty, and collectively the probability exceeded 50% that they, as opposed to nature, were responsible for the plaintiff's C. sakazakii infection, you have everything you need for legal causation and alternative causation ought to apply since plaintiff can't possibly prove where the bacteria came from, right? I don't think so.

Let's go back to David Hume and causation. Remember his quote: "We may define a cause to be an object, followed by another, and where all the objects, similar to the first, are followed by objects similar to the second. Or, in other words, where, if the first object had not been, the second had never existed." This is what we all today recognize as causation, or counterfactual causation; if "x" hadn't happened "y" wouldn't have followed. Easy enough.

Now think about causation in the case of Summers - in which the burden of proof was shifted from plaintiff to the two hunters, each of whom had failed to handle his firearm responsibly and had discharged his weapon in plaintiff's direction. What happens if the second hunter "had never existed"? It doesn't change anything. Causation falls on one defendant instead of two. The cause of plaintiff's harm would have been the act of the first hunter and liability would have been imposed on defendant by his own hand as he'd be the only cause left. But what happens in the Burks scenario if a defendant goes missing?

The Burks plaintiff sued two suppliers of a product potentially contaminated with C. sakazakii, a common environmental pathogen, and the probabilities are such that it's slightly more likely (51%) that plaintiff's infection was due to the contamination of one of defendants' products. Let's say the probabilities were 26% that it came from the first defendant, 25% from the second and 49% from Mother Nature who sprinkles the bacteria around many homes. The district court in Burks thought alternative liability would apply in such a case because the source of the pathogen was, collectively, more likely than not the defendants. But what if one of the defendants' breach of a duty "had never existed"? Suddenly the remaining defendant is not liable. What was determinative of liability?

If I've got this right then the rule in Burks is as follows: Whether or not you are liable for plaintiff's injury hangs on the conduct of third parties over whom you had no control. Right? And that can't be the law. Or is liability independent of likelihood such that it goes all the way down? More on that tomorrow (or the next day...)

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Very Little Authority For Now, But Maybe Not For Long

Two yellow pads are full of notes, diagrams, thoughts and arguments and still the answer eludes me. So, rather than continue not to post anything about all the interesting stuff going on in mass torts while I try to figure it out I'll just throw out what I've got so far over a series of posts and move on to something less difficult (and likely more interesting). On then to the question that's been bugging me for a month.

Should alternative liability, in the form of burden of proof shifting, apply in the following case: (1) a neonate contracted a Cronobacter sakazakii infection and was seriously injured; (2)  C. sakazakii is a ubiquitous pathogen and readily forms biofilms on stainless steel, inside household water pipes and upon other surfaces (3) C. sakazakii infections in neonates have also been repeatedly traced to PIFs; (4) plaintiff's experts opined that it's more likely than not that the source of C. sakazakii was the powdered infant formula (PIF) fed to the neonate; (5) PIFs are not sterile since the process of sterilization would destroy the nutritional value of the PIF; (6)  there were two or more suppliers of PIF whose product was prepared for the neonate; (7) none of the remaining PIF fed to the newborn, nor any of the lots from which they were drawn, were found to contain C. sakazakii; and, (7) the wrong complained of was a failure to warn that full term neonates, like the plaintiff, were at risk of C. sakazakii infections.

Alternate liability analysis often begins with Summers v. TiceIn that case both hunters who had fired their weapons in plaintiff's direction had been sued and both could be shown to have breached their duty to safely handle those weapons. Because it was impossible for the plaintiff to show whose buckshot was responsible for his injury, and because it was deemed just that the consequence of that impossibility fall on the culpable defendants rather than the innocent and injured plaintiff, the court held that the defendants, rather than the plaintiff, should bear the burden of proving from which shotgun the pellets had originated. Fair enough.

Here, in Burks v. Abbott Laboratories, both of the manufacturers of PIF consumed by the plaintiff had also been sued. Furthermore, neither's product bore a warning about the hazard which plaintiff claimed they had a duty to disclose. However, not all the possible sources of C. sakazakii (Mother Nature being judgment-proof) were before the court. Nevertheless, the court held, though it "located very little authority on this specific question" that  the determination of whether it was more likely than not  that the source of plaintiff's C. sakazakii infection was the defendants' PIF should be applied to the defendants collectively.

Ponder the consequences. Let's say that 51% of all C. sakazakii infections in neonates are due to PIFs even when C. sakazakii can't be isolated from the product or the lot from which it was drawn, and that 49% of all C. sakazakii infections in neonates are due to C. sakazakii found in the household water used to reconstitute the PIF or on kitchen surfaces. Also, assume the warning could fairly be said to be lacking (which in this case is not at all a given and in fact raises as many questions as stacking defendants to get to the 51% threshold - but that'll be addressed in subsequent posts).

If there's only one supplier of PIF there's no need for alternative liability so assume there are at least two. But what happens when you start dividing up the 51% among the defendants? Unless one of them was responsible for ~99% of the product the result is that you've stacked two defendants who might, but probably didn't, have something to do with plaintiff's infection and handed them all of the liability for it. Is that fair? What if there were 100 suppliers? And what's the justification for stacking defendants? Is it because they're in the same business? If so, how similar must their businesses be to permit such stacking? If in order to get to a 51% likelihood as to the source of the infection you had to stack PIF manufacturers with stainless steel kitchen appliance manufacturers (because C. sakazakii happily lives on stainless steel and creates biofilms that makes it nearly impossible to remove with household cleaning products) could you justify handing them the burden of proof by saying they were all in the food business? 

Or what about reducing defendants' liability by Mother Nature's share? Would that solve the "overdeterrence" problem? What follows from the fact that the potential for these sorts of infections, due to the nature of pathogens, is essentially binary (you get it or you don't) and not of the dose-response variety seen in typical mass tort cases?  These are the sorts of questions that have led to a lot of head scratching but so far few answers.Over the next couple of days I'll type up more of these questions and the paths down which they lead (at least the ones I've thought of and followed).

How a fact pattern like the one in Burks gets resolved is I think a very big deal. That's because an awful lot of diseases laid over the last forty years at the feet of man-made substances and bad habits turn out to have been due to pathogens all along. It also appears we're entering an era in which old scourges reemerge thanks to having evolved antibiotic resistance and new ones arise thanks to globalization.  The resulting morbidity and mortality will makesevery other mass tort pale in comparison and so far juries aren't having much trouble blaming defendants for the depredations of Mother Nature's tiniest critters. We think there's a wave of litigation coming in which plaintiffs will assert liability for facilitating the transmission of pathogenic agents. The answers to questions like those posed by Burks will be critical in determining how it all plays out. 

The Texas Supreme Court Has Decided To Hear Bostic

Here's some good news.

Though at first they decided not to hear plaintiff's appeal, the Texas Supreme Court has reconsidered. Hopefully that means there'll be an argument about the Dallas Court of Appeals' interpretation of Borg-Warner v. Flores in its Bostic opinion wherein it held that every putative cause to which liability may legally attach must be a "but for" cause.

The problem with Bostic, for asbestos claimants or any other claimant asserting a cause of action against multiple defendants each responsible for an act which was potentially sufficient to have caused plaintiff's injury, is that it created a rule whereby a plaintiff could not recover from any defendant so long as more than one defendant put in motion a series of events that could have lead to plaintiff's injuries. As we've been saying for months, the idea that if three defendants each negligently and separately start a fire capable of burning down the plaintiff's house she can't recover from any of them for the destruction of her house because she can't prove which one was the "real" cause is not only unfair, it hasn't been the law in Texas for a very long time. Anyway, we'll report on the briefs, the arguments and the result as the case proceeds.

In the meantime, we've been speculating about why the Court decided to give Bostic a second look. My pet theory is that someone dug into Dow v. Abutahoun, an opinion just a week or so old (and also from the Dallas Court of Appeals) and decided that for the first time since Havner a philosophical discussion about causation is in order. In Abutahoun the appellate court held that our Chapter 95 (triggering a requirement that plaintiff prove control over the contractor employee's work and actual conscious knowledge of the risk created) applies to a case in which employees of the premises owner create, or contribute to, the hazard of which plaintiff complains; so long as it was the same improvement to real property on which both contractor's and premises owner's employees were working. The idea seems to be, again, that when a defendant creates a risk of harm indistinguishable once manifest from those created by others, then the plaintiff bears the burden of proving that the putative harm was the "real" harm. That hasn't been the law and we doubt that the legislature intended such a result when it enacted Chapter 95. We'll see.

Finally, lest you think we've gone in the tank for plaintiffs, we'd note for the record that in both cases we'd hold for the defendant if we got to wear the robes - but we'd do it on different grounds. While it's impossible to say which fiber or group of fibers caused any given case of mesothelioma, it's easy for all sides to calculate the risk posed by any given exposure. And nowadays the exposures we're fighting over are typically minuscule and the risk associated with them are literally about the same as having a large meteorite explode 25 miles above your head. Which is to say that they've fallen to the point of simply being among those "ordinary risks of life" that make this life so interesting and so terrifying.

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Sam Hammared

Yet another court has sent packing Dr. Sam Hammar and his "every exposure", "every breath" method of causal attribution in asbestos/mesothelioma cases. This time it was a USDC in Utah (Central Division) that ordered such testimony be excluded; essentially by adopting the late Popperian view that "an untested and potentially untestable hypothesis" isn't the same thing as the "scientific knowledge" required by Rule 702. Ok, so why blog about it if it's not particularly surprising? Well, because it presents an opportunity to discuss (1) the perils of reasoning by analogy and (2) why fault is invariably and inextricably bound up with causation.

Hammar, no doubt invoking the linear no-threshold dose response model for carcinogens, countered the motion to exclude his causation opinion by elaborating that his attribution of causation to every exposure is proper because no exposure can be ruled out (since every fiber carries some risk). Then, either conflating risk with causation or using the "small glasses" approach (the order doesn't say which), Hammar concluded that if no exposure can be ruled "out" then every exposure must be ruled "in"; thereupon leading logically to his opinion that the plaintiff's mesothelioma "was caused by his total and cumulative exposure to asbestos, with all exposures and products playing a contributing role."

The court analogized Hammar's reasoning to that of a detective who, upon learning of a murder in a large family (and knowing that the killer is often found among family members), not only doesn't rule anyone out but proceeds to theorize that because none may be ruled out all must thereby be ruled "in". While agreeing that refusing to rule anyone out would be reasonable the court held that the same reasoning "would not allow the detective to attribute legal liability to every family member on the basis of such a theory."

Unfortunately there are a few problems with this analogy. First, unlike family members, within categories of fiber type asbestos is fungible and no technique exists that can differentiate by origin one fiber from another. Second, the scenario appears to assume a one-hit model of causation (i.e. that only one family member was actually responsible) - which is not (nowadays anyway) the causal model plaintiffs push in these cases. Finally, and most importantly, it ignores the fact that in a real case causation doesn't get plaintiff anywhere if he hasn't established breach of a duty (e.g. failure to warn).

Recasting the analogy to more closely mirror a typical case yields something like the following: the detective arrives at the scene of the crime and finds identical octuplets standing around the victim who has been crushed under the weight of several large rocks. Each sibling admits to having exposed the victim to one or more of  the rocks. That I think is more analogous to what the Fifth Circuit grappled with in Borel v. Fiberboard and it illustrates why in such cases courts shift the burden of sorting it all out from the plaintiff to the defendants. It's because no matter which defendant or which combination of defendants is held liable they're necessarily blameworthy and no one will think an injustice has been done.

But now let's update the analogy from 1973 to 2013. The detective arrives on the scene and finds the identical octuplets, the recently crushed victim nearby and each sibling admitting to having exposed the victim to rocks. However this time three of the siblings are found to have been responsible for nothing more than a handful of sand whereas the other five, all of whom were responsible for large rocks, are judgment-proof (thanks to bankruptcy court). Just as asbestos plaintiffs can't find any evidence that brake work increases the risk of mesothelioma, the detective can find no report of a handful of sand ever crushing anyone. What's a clever problem solver intent on blaming each viable defendant to do?

Hatch a "straw that broke the camel's back" theory which makes even a single grain of sand a necessary cause. Couple it with the linear no-threshold dose response model for carcinogens such that each grain of sand carried with it some non-zero risk of death by crushing and  you're golden -  your medical expert now gets to testify not only to causation but to the imposition of a risk, the magnitude of which (death) is enormous, on the decedent and, worse yet, without warning.

A number of courts intuit that there's something very much wrong with the theory but often can't quite pin down what that something might be. Here the court settled on the fact that the theory is untested and untestable. Now while it's true that no group of people who took one and only one breath of asbestos dust can be found and compared to another (equally nonexistent) group who never inhaled so much as a fiber, and no group of individuals can ever be ethically exposed to a known carcinogen just to see what happens to them, it's not clear why this ought to be a fatal flaw in plaintiff's theory. First, the theory is theoretically, if not practically, falsifiable and so under Daubert would avoid the label of pseudoscience. Second, would anyone really claim that in a hypothetical case in which the plaintiff was exposed to levels of asbestos that were higher than have ever been studied before that he couldn't recover because his theory that such massive levels of asbestos causes mesothelioma is untested and untestable? You get the point.

So if it's not a lack of testability, what's wrong with Hammar's theory? The problem is that it fails to assess the risk imposed, which is to say the defendant's conduct at the time of the conduct, and so fails to establish legal causation.

You can't go through life without kicking up some dust and it may well be the case that sometimes it really is one last straw, or one last grain of sand, that breaks the camel's back. But the focus of courts when deciding whether liability may justly be imposed should be on the conduct sought to be condemned. In the case of Smith v. Ford plaintiff sought to blame the defendant for a risk that was either nonexistent (as no study has ever shown an appreciably increased risk of mesothelioma among brake workers) or so small that it would take a cohort of many more people than have ever worked as brake repairmen to detect it. How can the imposition of such a risk, even if it exists, be a wrong?

It can't, or at least it shouldn't.

 

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Virginia Adopts the Davidson Rule (Hopefully)

Virginia's highest court is the latest  to wrestle with causation in asbestos/mesothelioma cases. Ultimately reversing a judgment in favor of Plaintiff and remanding the case for a new trial, the court in Ford v. Boomer decided that the substantial factor (or here, substantial contribution) test is unreliable and in any event inconsistent with Virginia law. The court embraced the Restatement (Third) of Torts' view of substantial factor causation (that it's incoherent), writing: "If courts cannot be relied upon to consistently construe the language, we cannot expect lay jurors to accomplish the same task." Concerned that the trial court's instruction to the jury, specifically that plaintiff must prove that exposure to defendant's product "was a substantial contributing factor in causing plaintiff's injury" left the jury free to assign liability to any exposure that was more than de minimis (the term was not defined), the court held that defendant's objection to the charge should have been sustained.

Ok, so if substantial factor/contribution cause doesn't cut it in Virginia what does? And if some exposure beyond "de minimis"  isn't enough, what is? Sufficient cause, i.e. sufficient exposure! In parsing the Restatement (Third) of Torts section 27 and its comments the court concluded that the logic of permitting a jury to assign liability to either or both defendants in a case in which each negligently started a fire sufficient on its own to have destroyed plaintiff's property would apply with equal force in an asbestos/mesothelioma case. Consequently, "[t]he exposure must have been 'a' sufficient cause..."

So how does a plaintiff show that a putative exposure was "a" sufficient cause? He'll need "medical testimony as to the requisite exposure necessary to cause mesothelioma, to determine whether the exposure attributable to each defendant was more likely than not sufficient to have caused the harm." And how does he show that the attributable exposure was more likely than not causative? That's the $64,000 question.

If all plaintiffs need is the ipse dixit of a high priced testifying expert then they'll just go from saying "any exposure above background was a substantial factor" to "any exposure above background was sufficient" and nothing will change. Presuming that Virginia is serious about requiring plaintiffs to prove that a given exposure (which is to say dose) could have been sufficient, plaintiffs will have to show that the exposure in question more than doubled the risk of the disease. Essentially it means drawing the line at the lowest dose credibly shown to double risk. That's nothing new. It's the rule Judge Davidson has been applying for years in the Texas MDL.

So good news for Virginia defendants, right? Well, in Texas we have a great shares defense and apportionment scheme. Virginia? This sentence from Boomer should answer the question: "Other sufficient causes, whether innocent or arising from negligence, do not provide a defense." The only defense suggested by the court for an exposure determined to be sufficient (other than a warning) would be to show that the exposure occurred after the plaintiff had already developed his cancer. That means Virginia's old school joint and several liability scheme prevents Boomer from being much of a boon to most defendants. Yet, because plaintiffs will have to prove something like a 0.1 f/cc-yr cumulative dose for each putative "sufficient cause", the most marginal of the remaining defendants should get some relief. At least until plaintiffs can show the background risk is say 1:2,000,000, at which time 0.05 f/cc-yr becomes "sufficient". Etc., etc. (Now do you see why we've been saying the Restatement (Third) of Torts is a Trojan horse for the Precautionary Principle?)

 

 

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Mass Torts Made A Surprise Appearance In The MOOC I'm Taking

The MOOC (massive open online course) is PH207x: Health in Numbers: Quantitative Methods in Clinical and Public Health Research and it's fabulous. The lectures are concise (they're often called "chunks") and for the most part do a fine job, step by step, of explaining the statistical tools for testing hypotheses and making inferences from data collected in public health research. The couple of lectures that left me scratching my head were quickly resolved by a visit to Khan Academy for a more detailed discussion of the math.

In the sixth week, while discussing hypothesis testing with two or more samples, Dr. Marcello Pagano (a great lecturer btw) decided to use the Bendectin story to illustrate the harm done when science is ignored. The story related was that a famous plaintiff lawyer had planted the story of "hideous birth defects" caused by Bendectin in the National Enquirer and that the cost of defending the ensuing litigation caused the maker to remove the drug from the market - with dire consequences for pregnant women with severe morning sickness. So far so good. But then Dr. Pagano put up a slide stating: "Not one court case lost."

Cases were lost and money was paid (even though the science behind the claims was fraudulent). So finally to the point of this post.

Just a month ago an expert (and former academic) that we're using on a case said, upon being told of the plaintiff's claims, (I'm paraphrasing) "I had no idea this went on. A professor at the law school told us that juries and courts are really good about separating shabby science from sound science and so plaintiff lawyers will only file meritorious claims." Right. Just ask Dow Corning how it worked out with their silicone breast implants. Anyway, there's a group of people out there spreading the story that Daubert isn't needed because junk science in the courtroom was never really a problem. Sadly, some really smart people believe them.

 

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Be Careful What You Wish For When You Wish For A Standardless Standard Like Lohrmann

As promised we're weighing in on Holcomb v. Georgia Pacific,  et  al - the most recent effort by a court, this time Nevada's supreme court, to paint a fig leaf over the judicial embarrassment that is modern asbestos litigation.

To recap, by 1989 (twenty years after Clarence Borel filed the complaint that launched the mother of all mass torts) the litigation appeared to be winding down. The personal injury (and school abatement) cases had bankrupted most of the companies that once had constituted the lion's share of the asbestos industry. A little over a decade later Pittsburgh-Corning, and soon thereafter Owens-Corning, sought bankruptcy protection. With that, market share-wise, the vast majority of the American "asbestos industry" had been put out of its misery. The remaining defendants (with the exception of Owens-Illinois which serendipitously exited the business back in 1958) were each responsible for a microscopic share of the asbestos used in the United States. Surely the end was near. Instead, because courts tended to create special causation rules in asbestos cases which conflated risk with causation and because those same courts assiduously avoided the question of whether some risks were so small that liability could not fairly be predicated on them, the litigation continued unabated.

Drowning defendants, desperate for anything that might help against the "every asbestos fiber poses risk, mesothelioma is the actualization of risk, therefore plaintiff's meso was caused by every fiber" sophistry that goes on down at the courthouse, often grab for Lohrmann v. Pittsburgh Corning . It's an 80's era asbestosis case holding, essentially, that two to three weeks of work cutting/applying Unibestos wasn't enough to impose liability on Pittsburgh Corning (though things went less well for the other defendants). There was no discussion of dose, nor of the relative potency of amosite nor of the risk posed by each of the defendants' products. Instead, Lohrmann accepted proof of frequent, regular and proximate exposure to a defendant's asbestos-containing product as a proxy for a quantitative assessment of exposure and thereby risk or whatever other consideration drove the court's approximation of the line between de minimis and non-de minimis exposures. But how frequent is frequent? How regular is regular? How proximate is proximate?

"It's better than nothing", one assumes the Holcomb defendants thought when they asked the Nevada Supreme Court to adopt the so-called Lohrmann standard. So how did it work out? Would plaintiff's testimony that exposures were "numerous" be sufficiently regular and frequent? Would working "around" a joint-compound user proximate enough?

According to the Nevada Supreme Court it's enough. And thus the problem with Lohrmann.

Today there's an extensive peer-reviewed literature demonstrating the typical distribution of exposures resulting from almost every conceivable use of asbestos, and a well refined risk model for asbestos-induced mesothelioma that lets anyone estimate the risk associated with the exposures described by a plaintiff and his co-workers. Coming up with a plausible range of exposure is neither too hard nor too expensive. Down here in Texas plaintiffs need someone to testify to a supportable dose range and a review of their experts' bills reveals a typical cost of about $2500 - a fraction of amount they spend on their experts who testify about the history of the use and recognition of the hazards of asbestos exposure. 

So would it be too much of a burden to make plaintiff state a supportable range of his likely exposure? The Nevada Supreme Court thought so - though it didn't say how much it thought such an estimation would cost, nor how much is too much. It also bought the straw man argument that states like Texas which actually ask "about how much" are instead asking the impossible to answer "state precisely how much". From there the court went on to conclude that an inference of causation may reasonably be drawn from expert testimony that infrequent and low level exposures can cause mesothelioma plus evidence that the plaintiff sustained "numerous" instances of working "around" the asbestos-containing product. And sure enough, that's the gist of Lohrmann.

As for why defendants continue to go from court to court demanding the adoption of the Lohrmann standard, that remains a mystery. As for why plaintiffs hate to say "about how much", we already know the answer - compared to the risks posed by some of the products now caught up in the litigation, taking a shower is a death defying feat.

2013 will be the International Year of Statistics. Maybe it'll be the year more judges and lawyers come to appreciate how much better our decision-making can be when we have the courage to demand the data and to accept what it implies.

 

Bostic Asks For A Rehearing And "But For" Causation Takes Center Stage

Kudos (despite their being a longtime and bitter foe) to Baron & Budd for doing a masterful job of demonstrating the flawed thinking behind, and absurd results implied by, Georgia-Pacific v. Bostic. As you know, the Texas Supreme Court recently denied Bostic's Petition for Review. Now Bostic has filed a Motion for Rehearing and this time has narrowed her focus to the appellate court's interpretation of "but for" causation. Here's our take.

Five years ago our supreme court authored a real gem in Borg-Warner v. Flores. The opinion recognized that while a plaintiff must prove her asbestos-related illness would not have arisen "but for" the asbestos to which she was exposed, she need not prove which among multiple sources of that exposure was the cause. However, she still had to prove that each source of exposure on which she sought to impose liability was a substantial factor in causing her illness. Because some of the exposures for which liability is nowadays sought to be imposed are very low, the court further required plaintiff to demonstrate not precisely, but rather within a reasonable range, the amount of asbestos to which she was exposed. As the risk imposed is the measure of legal causation, or substantial factor causation, and as dose is the measure of risk, the requirement allowed courts to make informed decisions when deciding, as a matter of public policy, which exposures could fairly result in the imposition of liability and which were de minimis and so could not. Then came Bostic.

The appellate court in Bostic decided that the "but for" test applies not to the question of whether the plaintiff's illness was caused by asbestos but to the question of whether each subset of the causative dose was the cause of plaintiff's illness. The problem with the latter formulation becomes clear when you consider its application to any case where there are multiple sufficient causes of plaintiff's injury. When a "but for" causation test is applied in such a case defendant X says "plaintiff can't prove she wouldn't have developed her illness 'but for'  my product because defendant Y would have caused it anyway" and defendant Y turns around and argues that it couldn't have been the "but for" cause of plaintiff's illness since defendant X would have caused it anyway. The result would be that none of the defendants could be found liable no matter how tortious their conduct.

As we've previously written, Texas' supreme court long ago recognized the absurd and unjust results that would follow from applying the "but for" test to each cause within the set of sufficient causes of a plaintiff's injury. It reaffirmed that view in Flores. Anyone interested in sound decision-making down at the courthouse should be hoping that the Texas Supreme Court reconsiders its decision not to look at Bostic. And if you're a big fan of Flores then you'll want Bostic's take on "but for" causation reversed.  Maybe then other courts, like Nevada's Supreme Court which recently decided Flores leans too heavily in favor of defendants, will see it for what it is - not an algorithm that dictates outcomes but rather a way for courts to intelligently draw a line around the outer limit of liability.  A line drawn according to each court's assessment of its impact; purely from a public policy perspective.

Next up: we'll put up a post on Holcomb v. Georgia Pacific, that Nevada Supreme Court opinion referenced above. Preview: as we've been saying for years defendants who run around asking for Lohrmann-esque standards need to think about what they're wishing for.

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The Court Of Appeals of New Mexico Came Thiiiiiiiiis Close To Reconciling Palsgraf With The Restatement (Third) Of Torts

Rodriguez v. Del Sol Shopping Center Associates presented New Mexico's appellate court with the sort of facts that makes judging hard. A mother, her young child and a health clinic receptionist were killed when a pickup truck crashed through the clinic's glass wall and into its reception area. The truck had been known by its driver to have a bad throttle and worse brakes. Its driver had a seizure disorder and had been told by her physician not to drive. She drove the old pickup anyway.

The pedal stuck, the brakes failed, the driver seized and the truck careened at just the wrong time and just the wrong place. Two sets of plaintiffs sued. They sued, among others, the shopping center which rented space to the health clinic. Their claims were of negligence. Specifically, that the accident was foreseeable and that the shopping center had breached its duty to the patrons of its lessees by not erecting barriers and installing signage that might somehow have prevented the tragedy.

Summary judgments were granted to the owner of the shopping center by each of the two trial courts in which the claims had been filed. The courts reasoned that since "foreseeability is a critical and essential component of New Mexico's duty analysis" and since "a finding of foreseeability would require anticipation of a remarkable confluence of events", the shopping center owed no duty to its tenant's customers to guard against runaway pickup trucks. The cases were combined on appeal.

We knew things were going to get interesting when the Court of Appeals began its analysis with: "the now-combined cases serve to illustrate the fallibility of an overly foreseeability-dependent analysis by district courts tasked with determining order in a convoluted area of law". Things got more interesting still when the court, citing Edward C. v. City of Albuquerque, announced that New Mexico had adopted an approach "more consistent with the Restatement (Third) of Torts: Liability for Physical and Emotional Harm section 7, cmt. j (2010)". So would New Mexico decide, hindsight bias be damned, to let juries impose liability whenever 20/20 foresight would have prevented a loss?

Nope.

Instead, as have all courts thus far seeking to escape the absurd consequences of a literal application of the Restatement (Third), the court bolted for the public policy escape hatch. But instead of saying simply that there's a good such and so reason to exempt shopping center owners, the court dove into Palsgraf and that state's highest court's interpretation of it. For a moment we thought they were about to do something amazing.

The appellate court looked back on Solon v. WEK Drilling Co. and quoted approvingly the following: "Chief Judge Cardozo held in Palsgraf that there can be no duty in relation to another person absent foreseeability ..., it does not  follow that duty necessarily is present if risk of injury to that other person is foreseeable from one's acts and omission ..." So mere foreseeability isn't enough! Some foreseeable risks cannot be the foundation for liability! And then the court went on to recount that for 20 years some 26,000 vehicles had daily traversed the Del Sol parking lot each and yet only one, the one that killed the plaintiffs, had ever penetrated the building.

So is this it? Will the New Mexico court of appeals be the one to finally say that as a matter of public policy some foreseeable risks are too remote to permit the imposition of liability? Will it say that when risk can be quantified and is vanishingly small that there ought not be a duty to avoid it?

Alas, no.

At the last moment the New Mexico court swerved and chose the path of others trying to avoid the impact of the new Restatement. It decided as a matter of public policy that premises owners ought not have a duty to anticipate activities outside of, and thus not inherent to, their own. Why foreseeability ought to be left to the jury while "the disastrous consequences of remote mechanical and human fallibility" should not escapes us. Why not draw some lines?

Why not say that a 1 in 5 million risk of death is just too remote; and that forcing every shop owner to turn her store into a fortress to avoid such a possibility would overall do more harm than good? Why not just say that public policy recognizes we live in a world of inevitable risk? Why not indeed.

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Breaking Bread

Will the plaintiffs’ bar be able to break “Big Food”? Will added sugar be “the tobacco of the 21st century”? Is it true that “we make our food very similar to cocaine now”?  Has food overtaken smoking as the biggest preventable cause of morbidity and mortality in America? Science supporting such claims is woefully lacking and what little there is is doubtful at best. But it may not matter. As Mark Bittman put it in his op-ed piece lamenting the failure of GMO-labeling and soda-taxing initiatives (and calling for new strategies to be deployed in "the fight" against the food industry):

"When a healthy person drinks 10 sodas a day and develops Type 2 diabetes, sues Pepsi and wins, and that victory stands up in a higher court, the research will be validated.

While having lay juries vote for their favorite narrative is certainly not the hypothesis-testing approach contemplated by the scientific method, the practical effect of a torrent of civil judgments is as sure as the guillotine. And that, after all, is Bittman's point.

 

In the next few days we're going to launch an effort to tweet, daily, about the unfolding assault on processed food.  We’ll undoubtedly add to the list but for now we plan to organize our tweets across the following categories:

 

1)      They were the best of bugs, they were the worst of bugs

a.       Bad bugs

1.       E. coli O-167

2.       Salmonella

3.    Etc.

b.      Good bugs

c.       Tracing

2)      The Politics of food

a.       Food Modernization Act

b.      Food Labeling

c.       Federal initiatives

1.       FDA

d.      State initiatives

e.      “Joe Camel” is to cigarettes as “Cap’n Crunch” is to food

f.        Food pyramid

g.       Right to know

3)      Food Liability Law

a.       Common approaches to liability

b.      Other liability-assigning strategies 

c.     Outbreaks/Recalls/Product Defect

4)      Addicted to food

a.       Salt

b.      Carbohydrates (obesogens)

c.       Oils/fats/transfats/saturated fat

d.      Caffeine

e.      High-fructose corn syrup

5)      Marketing

a.       Proven?

b.      True?

c.       Trends

6)      Industrial food

a.       Processing 

b.      Additives (GRAS)

1.       Preservatives

2.       Sweeteners

3.       Flavorants

4.       Dyes

5.       Sodium

6.       Extracts

7.       Bacteria

c.       Luddism

d.      Herbicides / Pesticides

7)      Allergic to Food

a.       Man-made allergies

b.      Emerging allergens

8)      "Frankenfoods" / GMOs

a.       Functionality

b.      Altered risk/benefit profile

c.       Escape

 

If you find it at all interesting and think we ought to add something to the list, please let us know.

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Whither The Fungal Meningitis Litigation?

We were interviewed a few days ago for an article published in Business Insurance News and asked for our thoughts about the future course of the fungal meningitis litigation. What follows is an elaboration on our published comments.

With the death toll at 28, and with 377 confirmed cases of meningitis (plus nine other cases of peripheral joint infection) among those who received what was supposed to have been a parenteral compounded sterile preparation (CSP), it's hard to see how the compounder, NECC, could possibly satisfy the claims that will be brought. The task then for the plaintiffs' bar is to advance theories that will ensnare those entities and individuals who can. That means they'll be trying to push liability down the line to distributors, hospitals and doctors; and, back up the line to the drug manufacturer. Depending on what the NECC witnesses say they may even try to push liability sideways and out to those who supplied the equipment and even consulting services to NECC regarding its operations including its clean room and terminal sterilization processes. So how might plaintiffs attempt to establish liability?

For those down the line they may allege 1) failure to warn; 2) failure to test; and, 3) failure to re-sterilize. For those up the line they may, as with the Teva cases we discussed earlier this year, allege negligent and/or defective packaging - i.e. failure to break the doses into the smallest possible units so as to effectively eliminate multiuse and, in large part, compounding, altogether. Finally, for those who provided either the hoods in which the originally sterile products were opened and compounded, the equipment for terminal sterilization or the advice about how to set up and run the processes used to make CSPs they may allege product defect and negligence. "Ok", you say, "but wasn't this a one-off? A once-in-a-lifetime problem that can be laid at the feet of a rogue compounder?" Would that it were so.

Forty years ago hundreds and maybe thousands of Americans were killed as a result of just one wave of iatrogenic infections. See e.g. "Sepsis Caused by Contaminated Intravenous Fluids. Epidemiologic, Clinical and Laboratory Investigation of an Outbreak in One Hospital." And it has only been 10 years since the last time the CDC identified a compounding pharmacy as the source of meningitis cases due to contamination of the very drug at issue now - methylprednisolone. Add to that recent findings that (a) even experienced and well-trained compounders produce contaminated preparations more than 2% of the time (see "Aseptic Simulation Test Challenged With Microorganisms for Validation of Pharmacy Operators"), (b) bacteria have been demonstrated to feast on even some of the most toxic chemotherapeutic drugs; and, (c) just a handful of these promiscuous microbes can reproduce until they're several billion strong in just 24 hours, and perhaps a duty to warn of the risks of receiving CSPs can be fashioned. To that end try on this quote: "To prevent further outbreaks, the people administering the agents must fully understand the ability of these drugs to support microbial growth so as not to put the patients at risk", from "Bacterial Contamination of an Anesthetic Agent".

What about advocating a duty to test or re-sterilize CSPs on the part of those who distribute or administer them? This course looks less promising at first. Because of the chronic problem of iatrogenic infections due to CSPs, compounding pharmacies have been subject to strict regulation since 2008 under USP chapter 797. Their processes, particularly their clean rooms, testing and sterilization procedures, appear to be explicitly designed so that those who administer compounded drugs can rely on their warranty of being "sterile". Furthermore, opening sealed vials for testing or demanding that everyone down the chain of distribution have gamma radiation sources (which in some cases may damage the medicine being sterilized) to re-sterilize the product would either compound the problem (no pun intended) or create new ones.

On the other hand, an argument may perhaps be made for further testing or re-sterilization along the following lines: hospital compounding pharmacies and satellite compounding pharmacies are already responsible for far more cases of morbidity and mortality than the NECC-related fungal meningitis outbreak. The difference is that they tend to do it onesies or twosies-style - a pertinent quote being: "Finally, we must recognize that iatrogenic infections happen daily in our hospitals and other health care settings with much less media attention, and we must continue to invest daily in careful and insightful infection control policies to prevent, limit, and manage them."

So what about pushing liability back up the chain? This looks to be the least viable route. The successful claim in the Teva cases referenced above was to the effect that the company had facilitated the transmission of a pathogen (specifically hepatitis C) from an infected patient to multiple uninfected patients by selling its drug, propofol, in (potentially) multidose vials which were used to dose multiple patients - despite the fact that the physician who directed such use was blatantly violating the CDC's Standard Precautions which prohibit the use of multidose vials for more than one patient. The idea was that packaging parenterals in single dose vials (SDVs) was a simple and obvious solution to an obvious problem. The reality is that SDVs may not make any difference.

Dosing for most medicines isn't like setting the size for an aspirin tablet. Instead there's often a "Goldilocks effect" whereby only a certain and very precise dose, calculated on the basis of patient-specific parameters, does any good. Too much or too little is worthless or worse. That means that unless a manufacturer offers a nearly infinite range of doses the result is usually waste because not all of the contents of the vial are used, or all of it plus only a bit of another are needed. SDVs are then, in the eyes of many, a waste of money and, in the case of very expensive small batch drugs, a waste of lives. And the value of unused drugs discarded due to SDV rules is said to be approaching $1 billion annually. Furthermore, SDVs may also lead to more mixing and prep time in certain operations (all of which increase the risk of contamination) than might otherwise have occurred had larger quantities been available - see e.g. "Invasive Staphylococcus aureus Infections Associated with Pain Injections and Reuse of Single-Dose Vials - Arizona and Delaware, 2012". Therefore, imposing a duty on pharmaceutical companies to package drugs only in the quantity actually needed by each future patient (the only way we can think of to cut out the compounder) would seemingly put them in an impossible situation - damned if they don't package the drug in a standard SDV size and damned if they do - and, as demonstrated by the outbreak involving the reuse of SDVs, either way it would likely make no difference as the limitation SDVs seek to impose is easily wired around by lab technicians.

As for liability claims against those who provided NECC products or consulting for its clean room and sterilization devices and procedures we expect that to be a largely fact-driven issue turning on how and where the contamination originated in the process.

However it turns out we predict that these recent fungal meningitis cases are just the tip of a very big iceberg. Have a look at "Is There A Need For Autopsies In The Management Of Fungal Disease". An awful lot of people are dying of fungal CNS infections that nobody detects unless an autopsy is performed.

And while most of the cases reported in that and similar papers involved people with impaired immune systems an increasing number of fungal meningitis cases are being detected in immunocompetent individuals. Add to that the very interesting factoid that the case of meningitis that triggered the discovery of the current meningitis outbreak was caused by a strain of Aspergillus fumigatus not found in any of the recalled vials nor in any other patient - the rest due almost exclusively to Exserohilum rostratum which was found in recalled vials. Top it off with this afternoon's news that Bacillus species have been found in two other CSPs distributed by NECC and you have to wonder whether (a) the discovery of the fungal meningitis outbreak wasn't pure serendipity because the index case, a patient with a longstanding history of degenerative back pain, may well have gotten his infection as the result of some prior medical intervention but just happened to manifest symptoms and die after receiving an injection of the NECC CSP; and, (b) there aren't  therefore a whole lot more deaths attributed to stroke, etc that are in fact due to undetected iatrogenic infections.

In coming days we'll put something up on the defenses to plaintiffs' expected claims.

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The Texas Supreme Court Has Denied The Petition For Review In Bostic v. Georgia-Pacific

Plaintiff didn't get the votes she needed to have the appellate court's decision reviewed.  Chief Justice Jefferson and Justice Lehrmann noted their dissent to the denial. The order was "petition denied" and not "petition refused" so arguably Bostic is just the law of the Dallas Court of Appeals, 5th District and not the law of Texas.

What's likely to follow?

Any defendant whose act or omission cannot be shown to have been sufficient to produce (i.e. capable of generating the effect without the need for any other exposure or action) the harm of which plaintiff complains will move for summary judgment. Particularly in those cases in which the independent actions of multiple defendants produced an indivisible harm and plaintiff cannot show that the act of each alone had the potential to produce her injury.

Odds are the effect of this ruling will first be explored in Texas' asbestos MDL. We'll let you know how it goes.

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Discretizations

Reconciling G-P v. Farrar with Ford v. Dixon

Having declared Ford v. Dixon to be one of the best (and by that we meant most thoughtful, well-reasoned and game-changing) opinions in a long time the Maryland Supreme Court's take on a similar question in Georgia-Pacific v. Farrar had us wondering whether Ford v. Dixon could survive its gaze. Eventually, however, we took heart from the fact that Georgia-Pacific had played the Bostic gambit and thus can Farrar be distinguished.

The first third of the opinion dispenses with the claim that product manufacturers have no duty to family members exposed to a toxin brought home on the clothes of a bystander. That argument rarely goes anywhere as most courts tend to Justice Andrews' view expressed in Palsgraf when the act complained of is the dispersion of an amorphous, flowing hazard; as in the case of asbestos exposure. Thus, when a court "because of convenience, of public policy, of a rough sense of justice ... arbitrarily declines to trace a series of events beyond a certain point", it then must ask: does there exist a yardstick that might fairly reasonably, generally reliably and somewhat predictably allow it to draw such a line?  We've been saying for years that in the case of well-studied toxins there is - it's the approximate risk imparted by the particular dose.

When the risk imparted is so slight that imposing liability for it would be counterproductive or unfair (because, for example, life is rife with inevitable risks and the one in question is by comparison de minimis) a court ought to conclude that no duty is owed. When the risk is more than merely de minimis the jury, or court sitting as fact finder, expresses the community's view of whether the risk imparted was substantial - which is to say that it was, or was not, acceptable. And that's what Ford v. Dixon held. Instead, in Farrar G-P went up on yesteryear's causal theories: 1) regularity, frequency and proximity; 2) "any exposure above background" is not enough; and 3) any cause for which liability may attach must also be a sufficient cause.

In Farrar, a take-home case, the regularity, frequency and proximity test was easily met. Plaintiff's grandfather worked construction in the Forrestal Building for months and routinely was exposed to the defendant's product; the dust from which settled on his clothes which were then regularly shaken out and washed by plaintiff. The resultant exposures were estimated to be very high (though plaintiff's expert's claim that any time you see any sort of dust Merewhether's 5mppcf level for asbestos has been exceeded, goes nowhere here in his home state). An easy win for plaintiff.

G-P next complained that plaintiff had not established substantial factor causation. Unfortunately, "Georgia-Pacific never argued that the jury was led to believe 'that any exposure to any purportedly "low dose" of asbestos above background levels is a substantial factor in causing mesothelioma'. This is a new argument on appeal and thus has not been preserved", wrote the Maryland Supreme Court. Yet it decided to address the merits of G-P's argument anyway. Luckily for plaintiff, G-P decided to try the Bostic approach - which is to say it argued plaintiff must show that each exposure to asbestos "was sufficient to cause mesothelioma". Can you say "overreaching"?

As we've said repeatedly, the idea that a plaintiff must show that each defendant's contribution to her cumulative dose was a sufficient cause of her harm is manifestly unjust in any multidefendant toxic tort case  - see e.g.Borel v. Fiberboard. And frankly, the injustice worked by such a rule wouldn't be limited to toxic tort cases. Any case in which multiple acts were "but for" causes of a single harm would see all the defendants excused. Indeed, any case in which an act of the plaintiff herself was found to have been the proximate cause of her own harm would see every defendant walk since their conduct, however egregious, necessarily could not have been a sufficient cause of plaintiff's harm. Such a holding then would basically reconstitute the old contributory negligence bar. And nobody's going there; including the Maryland Supreme Court.

Ford v. Dixon recognized that we live in an age of acknowledged uncertainty; of risk. Thus when an expert said a risk was substantial but couldn't say how, or why, the Court ruled that "such testimony 'lacked any information that would "assist the trier of fact to understand the evidence or to determine a fact in issue'..." That fact issue being: whether or not the risk imposed was substantial. When G-P fought not on risk but on Lohrmann it failed to appreciate just how much causal thinking has changed in the last 25 years. Upon sensing at last the change that's afoot G-P tried the new approach, but was too late. The Maryland Supremes wrote "It would be fundamentally unfair to the litigants to decide this case on an issue not raised at the trial court nor, for that matter, briefed to us." And so G-P lost.

Dose is the measure of risk and risk is the measure of substantiality, get it?

Correction: An earlier version attributed Ford v. Dixon to the Maryland Supreme Court rather than the Maryland Court of Special Appeals. Many thanks to the unnamed someone who straightened us out about the structure of Maryland's appellate court system.

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A Blast From The Past

This is for those of you involved in the seemingly never-ending story of asbestos litigation.

Imagine that a court offered the following deal:

1) Pay only your infinitesimally small share of the asbestos put into the stream of commerce back when all those companies now owned by Warren Buffett were pumping out thousands or even millions of tons of it annually;

2) Plaintiff's can't call Brody or someone similar to say how asbestos supposedly causes cancer. There'll thus be no implication of the single fiber and so no story making it sound as if that lone fiber is the scientific equivalent of a .30-06 to the head;

3) Plaintiff's can't put on the history of asbestos thereby triggering the hindsight bias that makes jury Monday morning quarterbacking so prone to error (yet profitable); and

4) Plaintiff's can't recover punitives if you give up on your (fairly hopeless anyway) state-of-the-art defense.

You'd take that deal, wouldn't you? Well, by 1986 when I got to Beaumont (where it had all started almost two decades before with Tomplait and then, famously, Borel v. Fibreboard) that deal had been out there to be had by the still-solvent defendants for a few years. And yet they turned it down. Repeatedly.

Why? I've an idea, but it'll have to wait until tomorrow. But I can report that though the judges who offered such grand bargains back then were considered hopelessly pro-plaintiff they'd also invariably take away jackpot verdicts and, as I can attest from my first painter/AML case, humiliate in front of the jury plaintiffs' counsel who argued for big damage awards. 

Alas, the defendants fought on. And the plaintiff's bar got very, very, rich. You know what happened next.

Consider this story food for thought; and start your munching with Hardy v. Johns-Manville.

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When, If Ever, Does "Scientific Knowledge" Stop Being Scientific Knowledge?

Consider the following undisputed findings about a hypothetical substance and a hypothetical disease published in a wide variety of respected, peer-reviewed scientific journals:

1) There's a very strong correlation between the presence of the substance and the subsequent diagnosis of the disease; so much so that the presence of the substance more than doubles the risk of being diagnosed with the disease.

2) The more of the substance to which you're subjected the greater the risk you'll be diagnosed with the disease.

3) The findings above have been consistently demonstrated across numerous studies.

4) Some people carry a gene that causes them to actually make the substance, and lots of it; and they have a significantly increased risk of developing the disease

4) Several biological models have been developed and published that plausibly demonstrate how and why the substance causes the disease

6) Animal experiments also demonstrate that the substance and the disease go hand-in-hand and animals injected with the substance develop similar pathologies.

A strong association, dose-response, consistency, temporality and biological plausibility; what more would you possibly need to make a judgment about so-called "general causation" in toxic tort case? Nothing more, at least in many courts these days, which means that the substance in our hypothetical, which as you guessed was not so hypothetical, could be found to be the legal cause of the equally not so hypothetical disease. So what are they? Amyloid-beta and Alzheimer's disease, respectively; and recent announcements blowing gaping holes in the decades old hypothesis that amyloid-beta causes Alzheimer's ought to give courts pause before allowing even the best untested hypothesis to be passed off as "scientific knowledge".

The amyloid hypothesis, or amyloid cascade hypothesis, certainly was a sound hypothesis. Since 1907 when Alois Alzheimer noticed the amyloid plaques in the brains of the victims of what we now call Alzheimer's the two have been inextricably causally linked in the minds of many if not most researchers and over the years more and more observations seemed only to confirm the connection. Eventually there was so little doubt that amyloid causes Alzheimer's that hundreds of millions if not billions of dollars were spent to develop drugs to combat it. Some of the money was spent elucidating that pathways whereby amyloid is made in the body so that drugs could be designed to stop its production. Some of it was spent learning how amyloid molecules link together and fold up into tangles and pile up into plaques so drugs could be designed to prevent the folding or to untangle the tangles. Still more money was spent learning how amyloid was cleared, or removed, from the body so that drugs could be made to wash it away. Now the drugs have been tested.

The drugs worked as designed and the amyloid was reduced in volume or more neatly folded or scrubbed away. Unfortunately, the victims weren't helped and in fact the symptoms of many were made markedly worse. Why?

Because correlation isn't causation even if you do have a good narrative to go along with your coincidental association. Imagine by way of example that amyloid plaque deposition is a defense mechanism that guards against or ameliorates the effects of the assault of some unknown agent on neurons which assault ultimately leads to Alzheimer's. If that were the case it would be no more surprising to find amyloid near neurons than platelets near wounds and thus you'd no more blame amyloid for the observed neurological damage than you'd blame platelets for road rash (get well soon Dr. Rock, we're glad you were wearing your helmet!). And guess what?  Though the fortune wagered on the amyloid hypothesis being true surely attests to the degree of belief held by those making the wager one of the great things about skepticism is that not every scientist bought in to the amyloid hypothesis and they're out there now saying see I told you so and finally getting people to look at studies show nuns with tons of amyloid plaques and yet no Alzheimer's, mice that crank out the amyloid yet suffer no neurodegeneration and intriguing hints that amyloid may play a role in combating marauding microbes.

There's nothing wrong with how the amyloid hypothesis is playing out. It's how science works. It's finding a way through a vast maze, making your best guess, admitting when you've hit a wall, updating your beliefs, making your way back to the last fork that looks promising and doing it all over again. Of course if you bet on an untested hypothesis and it doesn't pan out you lose your time and money. If you're a scientist, engineer or investor that is. On the other hand, in civil courts across the country, vast fortunes are made on the basis of untested hypotheses and the great thing is that even if the hypothesis is tested and fails you don't have to give the money back.

Why some courts don't demand that hypotheses be tested before bestowing upon them the certificate of  "scientific knowledge" remains a mystery. Both the Bradford Hill causal criteria and their predecessor Koch's postulates include the not very surprising requirement that before causation is assigned you ought to see if preventing exposure prevents disease. Indeed it goes right to the heart of "but for", or counterfactual, causation - if the exposure hadn't occurred the disease wouldn't have occurred. Anyway, that's a mystery for another day. For today please ponder the following question and let us know your thoughts if you're so inclined.

In those courts where something like the amyloid hypothesis would easily have passed the test to be certified as "scientific knowledge" how would one go about getting it "decertified", as it were? Would it be a sort of un-Frye test whereby you'd have to line up scientists to testify that the "knowledge" was now generally unaccepted. Or would it be a Daubert affair and if it was how would it work in a court in which a hypothesis need not be tested to be considered "scientific knowledge"? Think about it. How could the subsequent failing of a test that wasn't necessary to deem a hypothesis "scientific knowledge" in the first place logically alter the status of the hypothesis? See our point? Courts that lower the standard for what constitutes scientific knowledge may be opening a box that cannot be reclosed. Maybe that's the point. Let us know.

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Causation is Hard: Multiverse Edition

While we wait to critique Steve Gold's upcoming defense of Milward v. Acuity (the paper is available at SSRN but, alas, it's flagged as a work in progress, neither to be quoted nor cited) we'll have a go at his new paper on causation titled "When Certainty Dissolves Into Probability: A Legal Vision of Toxic Tort Causation for the Post-Genomic Era".

It takes twenty eight pages to get to the meat of the paper and upon arrival, despite some serious disputes with his take on causality, we were pleased when we finally made it (for awhile at least).  That's because it read as though Gold seemingly endorsed the same sort of approach to causal apportionment that we've been advocating here (and elsewhere) for years. Consider his suggestion:

I propose that courts should adopt an expressly probabilistic view of causation when the dominating evidence comprises population-based data of toxic effect. To frame the standard, an exposure should be considered a cause of disease if it was a contributing factor to the disease's occurrence. To be a contributing factor, an exposure would be shown by a preponderance of the evidence - not limited to any single favored type of evidence - to have added incremental risk that the plaintiff would develop a disease that the plaintiff has, in fact, developed. Damages should be apportioned to that contributing factor in proportion to its contribution to the plaintiff's risk.

Thereafter he even goes on to state that de minimis contributions to risk ought not be actionable. So what's not to like? Well, lots, actually. And it begins with a fundamental misunderstanding about "but for" causation.

Gold begins with the claim that "but for" (i.e. counterfactual) causal reasoning somehow doesn't work in toxic tort cases. He writes, "[p]roof of toxic tort claims conform poorly to the traditional deterministic legal model of but-for causation, because toxic injuries almost never involve an easily observed chain of physical events connecting a particular defendant's conduct with a particular plaintiff's harm." Gold's worry is that biomarkers, sequenced genes and the data from molecular epidemiology have delivered only more causal complexity rather than the allegedly promised "deterministic" certainty necessary for old-fashioned legal reasoning. So if "but for" causal thinking doesn't lead to the right legal solution, what does?

After pondering the conclusion that necessarily follows from the realization that e.g. cancer is the consequence of genes + epigenetic regulation + socioeconomic status + gender + microbiota + environmental exposures + unknown unknowns + bad luck (i.e. stochastic processes) Gold thinks he's fallen down the rabbit hole and met Schrodinger's cat and it's both alive and dead all at once. Confusing the uncertainty (which is to say ignorance) described by the statistics used in population studies with quantum indeterminancy, Gold declares that the real problem is one of "scientific indeterminacy". By this he seems to think that because the precise chain of events leading to disease is not only unknown but ultimately unknowable, and because randomness may lie literally at the root of the universe, it is therefore impossible to say that "but for" a particular exposure plaintiff would not have developed her illness.

That's bad enough because we know it's not the wave function that killed Schrodinger's cat . It was the decaying atom; and every time the atom decays the cat must surely die. But it gets worse.

Gold then suggests that the answer is not to live with the uncertainty - i.e. to make our best judgment about whether a gene or exposure or whatever was more likely than not a cause such that the disease would otherwise not have arisen, determine the risk it posed ex ante, and then apportion liability among those non-de minimis tortious risks ex post. Instead he suggests we throw every black box risk factor that passes his lowered Milward v. Acuity test of so-called general causation out for the jury's consideration, bad genes included and then let the them apportion liability among all risk factors, tortious and otherwise. He's thus changed the formula from Liability = Duty + Breach + Causation + Harm, to Liability = Duty + Breach + Risk + Any-disease-that-has-ever-been-associated-with-that-risk-even-if-it-probably-wasn't-causative-in-this-case.

In part II tomorrow we'll explain why such a formulation would vastly expand the number of defendants swept up into toxic tort litigation and why his belief that even with a tiny risk "someone somewhere" is ultimately harmed is true only if A) risk factors mean something beyond how likely it is we're wrong about our causal inferences; and, B)  there's a whole lot more universes out there besides our own.

Discretizations

Gods of the Analytical Gaps

Kuhn v. Wyeth, one of the many hormone replacement therapy (HRT) - induced breast cancer claims unleashed after one arm of the WHI revealed that the risks of HRT outweighed any benefits, is another case in which a court has concluded that a reasonable though untested hypothesis is good enough for Daubert purposes.

The WHI was the first randomized controlled trial (RCT) to examine the effects of HRT on breast cancer risk and it remains the most powerful study yet to address the question. Kuhn's problem was that this central pillar of the litigation showed that there was no increased risk of breast cancer for short term (<3 yrs) users like her. Plaintiff's expert thus needed to find a way around the WHI study while preserving its main finding.

With the help of plaintiff's counsel her expert rummaged through three observational studies and identified data which, when considered together, are indeed suggestive of an increased risk at exposure durations less than three years. However, 1) none of the studies were RCTs; 2) the largest (The Million Women Study) is laden with potential biases and confounders and doesn't even prove that HRT causes breast cancer; 3) the Calle study relies on self-reporting of past use (a notorious source of bias) and anyway didn't even find much of a risk increase until after the third year of use; and, 4) the final study, by Fournier, et al, explicitly disclosed that "[w]idespread use of progesterone is a French peculiarity" such that the drug combination being primarily studied wasn't even the one Kuhn blamed for her breast cancer. After a hearing on a motion to exclude the magistrate judge deemed the testimony unreliable. On appeal the 8th Circuit reversed.

The court held that "[t]aken together, the Calle study and the foreign studies constitute appropriate validation of and good grounds for" plaintiff's expert's opinion. There's no discussion of what constitutes "appropriate validation" of an expert's opinion nor the "good grounds" for holding it but it appears that plausibility was the only test being applied. What the court did was to examine those subsets of data within the three observational studies relied on by the expert, along with his explanations as to how they fit together, and thereafter conclude that the bits of data as framed by the expert do indeed support the theory of an increased risk for short-term users. And it's actually a plausible hypothesis. But is a plausible hypothesis the sort of "scientific knowledge" that satisfies Rule 702? We don't think so.

There's a whole journal dedicated to clever medical hypotheses - each hypothesis typically resting upon a lot more than just bits of three articles. The journal exists to "publish papers which describe theories, ideas which have a great deal of observational support and some hypotheses where experimental support is yet fragmentary" and the ideas submitted for publication are first "reviewed by the Editor and external reviewers to ensure their scientific merit" and reviewers judge the papers based on their plausibility. And even after all that what gets published isn't "scientific knowledge". What's published are just ideas;  potentially big ideas; yet nothing more than interesting ideas, until they're put to a test - a severe test - and survive it. That's science, and only the ideas that survive its testing can claim to be scientific knowledge.

As for the law, in a courtroom in Arkansas an expert witness will be allowed to advance as scientific knowledge a medical hypothesis conceived by a lawyer and fleshed out by the expert in just 5 hours. Scientific knowledge won't be needed to bridge the analytical gap between a tragic case of cancer and the drug combination claimed to be responsible. An untested yet plausible hypothesis, judged according to the persuasiveness of the expert advancing it, will suffice. We call the experts who can pull it off Gods of the Analytical Gaps.

Judge Robreno Just Knocked Unimpaired Maritime Plaintiffs Out Of The MDL

If you're a maritime plaintiff and are unimpaired mere pleural thickening won't save your asbestos claim.

For those new to the business it was for years the case that asbestos plaintiffs could bring personal injury claims without having to prove that they were injured by exposure to asbestos. It was among the "special rules" many courts crafted for asbestos claims. Another such rule was that a plaintiff didn't have to prove that a defendant's asbestos-containing product actually (or even probably) caused his pleural thickening. The result was the spectacle of Cimino in which hundreds of unimpaired plaintiffs with pleural plaques would recover $558,900 apiece.

Could it be that the end of the "elephantine morass" is at last in sight?

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The False Claims Act, Academic Fraud and Statistical Inference

We thought about throwing up a post discussing US ex rel Jones v. Brigham and Women's Hospital and Harvard Medical School last month but couldn't come up with a good tie-in to mass torts, toxic torts, regular-old-torts or any of the science stuff we like to write about. 

US ex rel Jones is a False Claims Act case arising out of an allegation that a researcher "deliberately manipulated [data] in order to achieve statistically significant results". Had the results not been statistically significant the researcher "could not have reported his findings in published scientific journals or to the NIH in support of an application" for the grant made the basis of the FCA claim, said the government's expert. The trial court granted summary judgment for defendants but the 1st Court of Appeals reversed. Scientific fraud will at last be on trial.

But ok, somebody(ies) cooked the books to get a bunch of NIH grant money. We're shocked. Shocked! that a tool created for gamblers has been used to burnish entreaties to the National Institutes of Health based on probabilistic reasoning. Alas. That's where we left it. Then we read "Fraud-Detection Tool Could Shake Up Psychology".

It discusses a statistical tool that lets its user surmise whether or not a researcher being investigated has been cherry-picking the data and consciously, or perhaps unconsciously, excluding data  that undermine his hypothesis. Apparently, by excluding data points that severely conflict with his hypothesis, a dishonest researcher can (surprisingly) reduce variance and thereby increase significance. The problem for the dishonest researcher is that across all the data a histogram of randomly generated p-values is supposed to look like this whereas the dishonest researcher's p-values produce a histogram like this.

There's nothing that limits the tool to empirical psychology; a discipline which has been rocked by repeated episodes of fraud involving researchers bent on generating "science" that confirms the common sense notions of one group or another. These days pretty much every researcher has the computing power necessary to see which data are critical obstacles in the path of "proving" a hypothesis. Thereafter he can generate ad hoc rationalizations for excluding the troublesome data; or just ignore them altogether, or just nudge them off the table and into the trash can. Problem solved!

Now we can see who's been solving problems by ignoring (or deleting) problematic data.

So how did we get here; a place where we need such a tool? Why are most hypotheses supported by statistical data probably false; and why is a lot of what's false actually fraudulent? US ex rel Jones manages to let slip the root cause. Rather than confining significance testing to saying something about whether a hypothesis is probably wrong it is now commonly, and wrongly, thought "to cause proof of a particular scientific hypothesis to emerge from  the data." Thus, rather than discovering if, on our endless ordeal of trial and error, we've gone off the rails yet again (which is to say that our pet theory has likely been falsified) many have come to use these tools to establish the claim that their hypotheses have been verified (or, worse yet, proven).

And that gets us to the essence of science. If, per our reading of Karl Popper, all we know is what isn't so, then the way forward to truth is heralded upon saying of new data: "That's funny". Similarly, the claim that our dogmas, preconceived notions, biases or prejudices have been verified by science ought to immediately summon our inner skeptics. Of course, too many are content to be fed a steady diet of seeming affirmations of their own convictions. But whichever side of the falsificationist/verificationist divide you fall on, our guess is that in the years to come the application of statistical tools like the one described above will open your eyes. Many things we thought of as "science" may turn out to have been the result of an elaborate fraud. Let the chips fall where they may.

The Best Causation Opinion of 2012

In fact, it may well be the best causation opinion of the last half century; and we're willing to bet it will be one of the most important causation opinions going forward. Dixon v. Ford Motor Company nails substantial factor causation and in the process proves that there are still plenty of judges willing to think deeply about causal inference, about uncertainty and about the limits of liability in a world of inevitable risk. Ultimately, the court held that risk is the measure of legal causation in those cases where causal inferences are made probabilistically, and therefore when a causation expert opines that a putative cause was a "substantial factor" without saying how much risk it imparted she fails to answer the question she was called to give; and so has nothing helpful to say about the matter.

Dixon is another tragic mesothelioma case in which a defendant, having contributed to the victim's cumulative asbestos exposure something between nothing and next to nothing, was hammered by the jury. It then appealed, after taking a few judicial deductions, a $3+ million judgment. As usual the defendant complained that plaintiff's causation expert (this time an epidemiologist) ought not to have been allowed to testify because she had "extrapolated downward" from the known segment of the asbestos/mesothelioma dose/response curve to an area in which hard data was lacking and thus could not reliably say that the defendant's small contribution to the victim's dose was a substantial causative factor. 1) That's not plaintiffs' game these days, as we said in Small Glasses; but more importantly, 2) as the court made plain in Dixon, "substantial factor" in such cases isn't about causation, it's about risk.

"'Substantiality' is a legal concept and not an objective property testable by the scientific method", wrote the Dixon court. The question thus required to get at the essence of substantial factor causation in a dose/response disease case is not "was it a big cause or a little cause?" It's not even "was it really and truly a cause?" The first question is nonsensical and the second is unanswerable. Instead, the question is: "assuming it was a cause, was the risk it imparted prospectively of such a degree as to justly warrant the imposition of liability?" Risk, said the court, is thereby the measure of (legal) causation and proving that the risk imparted was substantial is plaintiff's burden. Showing that defendant imparted a substantial degree of risk, according to the Dixon court, is thereby what is required to bridge the "analytical gap" between "asbestos causes mesothelioma" and "plaintiff's exposure to defendant's asbestos caused her mesothelioma".

Accordingly, the court held that when all plaintiff's causation expert could say about causation was that "every exposure to asbestos is a substantial contributing cause" the only thing she wound up saying about the risk given plaintiff by Ford was that it was "more than nothing." "For obvious reasons an infinitesimal change in risk cannot suffice to maintain a cause of action in tort". Thus, the opinion of plaintiff's expert "merely implied that there was some non-zero probability that [plaintiff] was exposed to asbestos from Ford's product, and that this resulted in some non-zero increase in her risk of contracting mesothelioma. As such, [the conclusion of plaintiff's expert] that the risk and probability of causation was 'substantial' provided the jury with nothing more than her subjective opinion of 'responsibility,' not scientific evidence of causation."

So how does a plaintiff establish a substantial risk? Not by proving the exact dose and thus exact risk incurred.The Dixon court disposed of the straw man argument that requiring plaintiff to show risk (and thereby dose) quantitatively demands an impossible degree of certainty and precision. Such a rule, wrote the court, would obviously be "folly". Rather, all plaintiff is being asked to do is to "estimate exposure and risk with reasonable scientific or medical certainty." Once such an estimate is made the jury can decide whether it is sound and if so whether the risk imparted was substantial - subject to the law's requirement that it be more than de minimis.

That's exactly what we've been arguing since a client was kind enough to let us write an amicus in Borg-Warner v. Flores. Make the plaintiff say what dose, and thereby what risk, was given. Why? The effect of plaintiff's estimate of dose in one of the first post-Borg-Warner cases should suffice for an answer. Using their expert's dose estimate the calculated risk of death posed by our client's product was demonstrated to have been less than 1 in six billion; that's equivalent to the risk of death (from cancer caused by radon) imparted by spending just fifteen minutes in a building constructed of brick or stone. Such calculations and comparative risk exercises serve to vividly demonstrate both the de minimis nature of the risks imparted and the absurdity of imposing liability for them.

Discretizations

Small Glasses

The Betz v. Pneumo Abex commentary has generally sounded the following themes:

(a) The "novelty" threshold requirement for a Frye hearing has a broader meaning than previously thought. Henceforth, "a Frye hearing is warranted when a trial judge has articulable grounds to believe that an expert witness has not applied accepted scientific methodology in a conventional fashion in reaching his or her conclusion."

(b) The trial judge, who "was unable to discern a coherent methodology supporting the notion that every single fiber from among, potentially, millions is substantially causative of disease", did not abuse his discretion by excluding the "every fiber" causal theory of Dr. Maddox.

(c) Maddox' opinion that "every fiber was a substantial factor in causing plaintiff's mesothelioma" is riven by an "irreconcilable conflict with itself" because "one cannot simultaneously maintain that a single fiber among millions is substantially causative, while also conceding that a disease is dose responsive."

(d) Maddox reached his conclusion about causation not by his claimed "series of 'small bridges'" but rather by improperly extrapolating from known portions of the asbestos/mesothelioma dose-response curve to find causation at much lower levels - levels never demonstrated by epidemiological studies to be associated with the disease.

We're glad, of course, that the court found that novelty doesn't wear off expert opinions (i.e. they don't become immune to scrutiny under Frye) just because they've been peddled to many juries for many years. And we're similarly pleased so see shot down the untestable/unverifiable/unfalsifiable claim that a single fiber not only might have caused, but was in fact a substantial cause, of a given case of mesothelioma. But we're afraid the court missed the subtle game Maddox was really playing.

He wasn't extrapolating down. He wasn't playing the one-hit, linear no-threshold, conflate causation with risk game (though he does in other jurisdictions). And his causal model can account for both a single fiber being a necessary cause of a given plaintiff's mesothelioma and a correlation between dose and disease without any tension. Best of all, it's perfect for exploiting jurisdictions with naive liability attribution schemes such as Pennsylvania's at the time Maddox's opinion was rendered (Pennsylvania finally overhauled its joint and several liability scheme in 2011).

To understand what's up think about the following opinions of Maddox:

1) "it is the total and cumulative exposure that should be considered for causation purposes."

2) "Cumulative exposure, on a probability basis, should thus be considered the main criterion for the attribution of a substantial contribution by asbestos to lung cancer risk."

and,

3) "[T]he more common analogy that has been used is the example of a glass of water. One drops marbles into the glass of water until the water finally overflows from the glass. Is it the first marble or the last marble that causes the glass to overflow? Well, both, all of them. The marbles cause the glass to overflow. That's a cumulative effect."

So it's clearly not a one-hit model that he's proposing; and for good reason. As more and more courts have become savvy about risk it's been harder and harder for plaintiffs to survive the objection that a de minimis exposure presents a de minimis risk and thus cannot by necessity be a "substantial factor". That's what the Pennsylvania Supreme Court was getting at in Betz when it wondered how "if all Dr. Maddox could say is that a risk attaches to a single asbestos fiber - that he could also say that such risk is substantial when the test plaintiffs may have been (and likely were) exposed to millions of other fibers from other sources including background exposure."

The point is made explicitly a few pages later when the court refers back to its discussion in Gregg about the plaintiff's proof problem in such cases:

"... we do not believe that it is a viable solution to indulge in a fiction that each and every exposure to asbestos, no matter how minimal in relation to other exposures, implicates a fact issue concerning substantial-factor causation in every "direct-evidence" case. The result, in our view, is to subject defendants to full joint-and-several liability for injuries and fatalities in the absence of any reasonably developed scientific reasoning that would support the conclusion that the product sold by the defendant was a substantial factor in causing the harm."

So what sort of model makes each asbestos fiber a substantial factor in causing mesothelioma and yet is consistent with a dose-response relationship between asbestos and mesothelioma? It's something we're seeing more and more often. It's the idea that each person has, to apply Maddox' metaphor from above, her or his own unique water glass of a defense mechanism. Some people's defense capacities are bigger and some are smaller and some are microscopic. But whatever the size, once they're overwhelmed mesothelioma or leukemia or whatever ensue. Thus, when Maddox says that every fiber to which plaintiff was exposed contributed to his risk and "once an individual develops a mesothelioma, the risk becomes the cause" what he's really saying is that though some marbles dropped in the glass might be bigger than others (e.g. crocidolite > amosite > chrysotile) and some might have been added with thimbles while others with coal shovels the only thing that really matters is whether or not the body's defenses were breached. Once they are the glass overflows, the mesothelioma develops and every last fiber was literally a necessary "but for" cause of the disease.

So what does the dose-response curve for asbestos and mesothelioma actually represent in such a model? It describes the outcomes of varying abilities to withstand asbestos across varying levels of exposure to asbestos. A lower defense capacity (small glass) requires less asbestos to trigger mesothelioma; higher defenses require more, etc. Think of the data points on the curve then as small glasses that have overflowed. What such a model suggests is a human population that mostly has large glasses {which fits the observation that even the most heavily exposed workers have less than a 1 in 10 chance of developing mesothelioma); a small portion has small glasses; and a tiny portion have smaller glasses still - all the way down until you get to those rare but unlucky souls who have no defense whatsoever. For them the background exposure dose doesn't increase their risk since it's already 1.

It's an especially clever model for for litigation because:

a) every fiber is a necessary element of a sufficient causal set (NESS) so causation is a snap;

b) it escapes the no duty problem posed by de minimis exposures in states that view substantial factor causation from a risk/foreseeability perspective;

c) it turns modern victims into eggshell plaintiffs and so makes every case that much more foreseeable; and,

d) because it's a Landers v. East Texas Salt Water Disposal Co sort of cumulative causal claim it's especially dangerous in states with joint and several liability schemes.

The problem is that there's no evidence for the model. It rests solely on the following two generalizations (that do little more than highlight our ignorance of the mechanisms whereby asbestos causes mesothelioma) and the conclusion drawn from them:

Mesothelioma is caused by exposure to asbestos fibers

A victim's asbestos exposure consists of every fiber inhaled

Therefore, a victim's mesothelioma was caused by every asbestos fiber inhaled

As for the equally evidence-free small glasses theory it goes like this:

Not everyone exposed to asbestos develops mesothelioma

But every victim's mesothelioma was caused by her or his asbestos exposure

And every victim has had a different asbestos exposure

Therefore something about the victim (small glasses) determines the outcome of exposure

If you haven't seen it yet it's surely on its way to a courtroom near you. Our advice? Attack the premises - they're made of clouds.

 

 

 

 

Kid! Be Careful! Broken Glass!

Bartlett v. Mutual, a Stevens-Johnson/Toxic Epidermal Necrolysis (SJS/TEN) generic drug case that produced a $21 million judgment upheld on appeal, gave us writer's block.

Upon first reading of the opinion we thought Bartlett told the following story:

a) New Hampshire has adopted the controversial third aspect of the risk/utility doctrine so that plaintiff needed only to prove that the risk posed by the drug (sulindac, a non-steroidal anti-inflammatory (NSAID)) outweighed its utility (it's often prescribed for the sort of shoulder pain suffered by plaintiff as well as certain forms of arthritis).

b) In such cases "liability does not run through the warning label" so Pliva v. Mensing doesn't apply and there is no pre-emption per Wyeth v. Levine.

c) Mutual decided to put on no defense at all - not even to prove that its product had some utility.

d) Mutual got hammered.

e) Mutual thereafter sought to escape the consequence of its trial tactic with a kitchen sink appeal.

So there was lots to blog about. Can a jury, presented with only one salient data point, a woman devastated by SJS/TEN, do a better job of judging whether sulindac is safe and effective than the FDA? What other states allow jurors to decide whether a product should be marketed at all so that Pliva can be avoided in generic drug cases? Under what circumstances should a defendant consider placing all its chips on plaintiff's burden of proof? Why are the damage awards in SJS/TEN cases so high? Should appeals be rifle shots or shotgun blasts? But something about the narrative just didn't make sense. We couldn't figure out what it was so we thought maybe we could write something about the peripheral issues related to Bartlett.

For example, the court recognized that sulindac "has a minuscule risk of causing SJS/TEN" yet found that fact of no moment as Mutual hadn't proved its utility. So we could write about whether there ought to be liability for de minimis risks when we already live in a world of inevitable risks. Then there's the question of causation. Plaintiff had less than 100 cases to point to over a quarter century and nothing to tie them to sulindac other than that prescription preceded onset. Or we could write about the irony of holding that it's sensible to let a jury decide that sulindac should not be sold in New Hampshire at a time when sulindac is generating lots of excitement about its ability to fight cancer of the ovary, breast and colon while preventing new cases via anti-inflammatory / pro-apoptotic mechanisms. We even considered musing about why there seem to be more more SJS/TEN cases and who's responsible for the hypersensitivity reaction since it's starting to look as though the blame falls on early gut microbiome disruption precipitated by antibiotics.

But our minds kept wandering back to the opinion. Why doesn't it make sense? Exactly what is wrong with Bartlett? Finally we remembered Irwin Mainway and his Bag O'Glass.

What would be the reason for talking about a product's warning when the claim is that no warning could ever render it more useful than risky? I can't think of a good one. Nevertheless, the trial court, on the day before trial, "ruled that warning-related evidence would be admissible, to a limited extent, with regard to the issue of whether sulindac was unreasonably dangerous." Hmmmm. Isn't that reasoning circular? Think about it: the label is inadequate because the product is unreasonably dangerous and the product is unreasonably dangerous because the label is inadequate. That's what the trial and appellate court are saying. That's how Bartlett turned an untenable marketing defect claim into a design defect claim against which Mutual had no real defense.

Here's how it worked. Originally plaintiff claimed that the sulindac warning was defective because the label didn't mention SJS/TEN. However, the warning label did say: "Hypersensitivity. Rarely, fever and other evidence of hypersensitivity (see ADVERSE REACTIONS) including ... severe skin reactions have occurred during therapy with sulindac. Fatalaties have occurred in these patients." Furthermore, according to the trial court "[t]he label expressly listed SJS/TEN as potential adverse reactions in its 'Adverse Reactions' section." Things got worse for plaintiff once the treating doctor was deposed.

Bartlett's treating physician "admitted at his deposition that he never reviewed Mutual's sulindac label before treating Bartlett and that 'nothing about it influenced [his] prescribing of the drug' or what he told Bartlett about it." Because '[c]ause-in-fact requires the plaintiff to show that the injury would not have occurred but for the negligent conduct" which in turn, "requires the plaintiff to establish that the negligent conduct was a substantial factor in bringing about the harm ...  Bartlett 'must prove that had the learned intermediary [i.e., her doctor] been warned adequately, the drug would not have been used, or would have been used differently.' 5 Louis R. Frumer & Melvin I. Friedman, Products Liability § 50.05[4], at 50-84 (2010)." Since the label was never read its contents could not have affected the outcome. The court thus held "Mutual is therefore entitled to summary judgment on this issue."

So Bartlett needed a cause of action that would allow her to bypass the warning, but it had to sound in strict liability because she couldn't prove proximate cause either. Since molecules can't be redesigned and since the sulindac had not been mismanufactured the only avenue left was marketing defect where the product of proximate cause's foreseeability inquiry would necessarily manifest itself as a  warning - which led right back to the problem that the label had never been read. With some help from the trial court she seized upon the idea that some products, like Bag O'Glass, "are too risky to even be marketed." But how could she prove it was too risky to ever be marketed?

Bartlett used the sulindac warning, a warning that was neither the proximate nor even the "but for" cause of her injury, to prove that sulindac was too risky. She said what made it too risky was that there was no reference to SJS/TEN in the warning section of the label. And by what authority did she claim to be able to do that? Restatement (Second) section 402A's comment k, added to ensure that negligence principles would be applied in claims over unavoidably unsafe drugs. She argued that risky drugs need "proper directions and warning" and thus drugs lacking them are necessarily too risky! Then she turned around and argued that too risky drugs are ones that should never be marketed because no warning can sufficiently modulate their risk. She thereby avoided the impact of the label's never having been read and Pliva all at once. Better yet, the "comment k defense" was now turned into a trap for Mutual so that almost any evidence it put on would support Bartlett's circular claim. When Mutual decided not to set a foot in the snare the court blamed Mutual's loss on trial tactics gone awry. What a nightmare.

Well, that's that. Now we know what was bugging us - bootstrapping.

Bag O'Glass was too risky because of its innate properties and not because the warning, "Kid! Be Careful. Broken Glass!", made it riskier. Irwin Mainway's argument that a warning could alter the risk posed by a too risky product elicited derisive laughter from the SNL audience. In the 1st Circuit the argument elicited an affirmation of the conclusion derived from it.

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"[A]dopting the Third Restatement Would Increase the Expense of Litigation"

An Arizona appellate court has looked at the evisceration of duty in the Restatement Third and recognized the effort for what it is: an approach that "significantly lessens the role of the court as a legal arbiter of whether society should recognize the existence of a duty in particular categories of cases; for this reason, adopting the Third Restatement would increase the expense of litigation." Accordingly the court held that while "restricting the dismissal of negligence actions for lack of duty may be thought desirable as more protective of a litigant's jury-trial right, such a fundamental change in the common law requires an evaluation of competing public policies that is more appropriately addressed to the Arizona Supreme Court" and so declined a request to adopt the Third Restatement. See Delci v. Gutierrez Trucking Company.

In Arizona duty remains an essential element of negligence. Which is to say that Arizona's courts, like most American courts, "do not understand the law to be that one owes a duty of reasonable care at all times to all people under all circumstances." Palsgraf lives.

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Discretizations

5-Methylene-1,3-Cyclopentadiene

I thought of fulvene, also known as 5-methylene-1,3-cyclopentadiene, when I read the following in a new law review article (funded, strangely enough, by a National Science Foundation grant):

Tort actions may impel industry to take voluntary steps to redesign chemical molecules ... to be less toxic.

Fulvene you see is made up of six carbon and six hydrogen atoms. So is benzene and so are a few other molecules. The point of course is that while you might be able to rearrange a car's component parts to make it somehow safer while leaving it a car you can't rearrange benzene's atoms (or those of any other complex molecule for that matter) without turning benzene into something else. Something with a different boiling point, solubility, reactivity and the like. Something that cannot, as benzene can, be used to make the breast cancer drug tamoxifen.

The law review article is "Litigating Toxic Risks Ahead of Regulation: Biomonitoring Science in the Courtroom" and it dovetails with "How Chemicals Affect Us" which you've likely seen in the NYTimes. Each claims that very low levels of exposure to substances previously thought safe may be causing subtle changes and each ends with a call for regulation; the former by way of lowering evidentiary standards in tort proceedings so as to bring about more claims and bigger awards and the latter by way of the regulatory state. Irrespective of wielder the same tool is urged: one that resolves all uncertainties in favor of stasis, of inaction, i.e. the Precautionary Principle.

"Litigating Toxic Risks", funded under a $366,785 research grant for "Toxic Ignorance and the New Right-to-Know: The Implications of Biomonitoring for Regulatory Science", proceeds from the hypothesis that "toxic tort litigation has emerged as a means of controlling risks." It recounts 1) the number of chemicals that have never been tested for toxicity (tens of thousands); 2) the non-stop synthesis of new ones; 3) the purported shortcomings of TSCA; 4) the fact that asbestos and lead paint are made of chemicals and turned out to adversely affect some of those exposed; 5) the apparently obvious conclusion "it follows that many of today's routine chemical exposures are cause for great health concern"; and, finally, 6) the ability of biomonitoring to demonstrate those chemicals to which we've been exposed. The authors then deduce that the effort to regulate chemicals via toxic tort litigation "depends greatly on whether courts are able to apply tort theories to the scientific data used in appraising the health risks of chemicals".

They lament, however, that there's no cause of action for simply being exposed to the activities of other people; that plaintiffs must show harm - an adverse health effect - before they can prevail. Regarding those chemicals to which everyone is exposed in low doses they complain that it's not practical for plaintiffs to do epidemiological studies since there is (unsurprisingly) no unexposed reference population. Furthermore, the cost and time involved in doing epi and tox studies are significant. So, if standards of proof could just be lowered the class action mechanism would expose potential defendants to existential liability risks for harms they probably didn't cause (see pg. 6) so that vast sums could be extracted from them and the production of synthetic chemicals would be thereby curtailed or eliminated.

Additional helpful measures would include dropping the requirement that class members demonstrate that they have actually been exposed to the substance in question. As support for this assertion the authors write "[t]he courts' current stance contradicts standard scientific procedure, where it is well recognized that sampling can lead to reliable assumptions about population characteristics". (Really? A calculated sample mean is superior to knowledge of the actual population mean for making conclusions about the population? And superior to even knowing the actual exposure of each member of the population?)

To make sure that as many people as possible can assert medical monitoring claims the article's authors urge "implementation of the precautionary principle in the legal standards required to show significant exposure and increased risk of disease". The precautionary principle apparently will turn every "is it likely" hurdle to plaintiffs' recovery into an "is it possible" speed bump.

As for damages "courts can accept, as legally actionable injuries, subtle health and developmental impacts as well as emotional concern and stress related to chemical exposure."

So far some 50 million different chemical substances have been cataloged and 12,000 new ones are added every day. Most were synthesized by nature rather than by man. Over the eons our ancestors managed to survive in this sea of chemicals, surrounded and inhabited by countless biochemical factories constantly synthesizing new molecules in order to survive in and/or exploit their ever-changing environment - and our ancestors largely did it by synthesizing their own new molecules. We've only had trouble when we've been out-engineered by our biochemical competitors or when we've violated the rule: "all things in moderation". So what's with the chemohysteria over trace exposures and the discovery that our bodies notice and adapt to them on the fly?

I think a large part of it stems from the fact that we've come to realize our genetic code is more toolbox than blueprint; that we're far more impermanent than we ever imagined; and, that so much of what we believed about how it all works, especially decades old myths about the principal causes of human diseases, is being swept away by remorseless empiricism. The attempt to incorporate the Precautionary Principle into the law can thus be seen as part of a deeply conservative movement, standing athwart science, yelling Stop!

 

 

 

Discretizations

Pretty Good, Except for Footnotes 82 and 105

See: "Admissibility Versus Sufficiency: Controlling the Quality of Expert Witness Testimony in the United States".

Though a co-author hails from a law school named after one of the lawyers who is said to have made hundreds of millions of dollars off of the breast implant hoax and the lead was one of the first experts called by plaintiffs to testify in Texas' asbestos MDL, they get it right, more or less, when writing that the decision to exclude an expert under Daubert is really a query into the sufficiency of plaintiff's evidence rather than the raw admissibility of the proffered testimony. Can the expert sustain plaintiff's burden of production? That's the question. If not, why bother wasting everyone's time and money to go through the motions of holding a horse race the outcome of which has already been decided?

Their second point, that Daubert's inquiries about falsifiability and the likelihood that the expert's method has produced a false positive, is less compelling. While it's true that you can find a heap of non-analytical philosophical papers positing that truth is personal, that the quest for objective knowledge is meaningless and that nothing can really be falsified, the people who design and especially the people who board airplanes prefer to have them tested first. So don't expect to see falsifiability or rate of error vanish anytime soon.

The third point, that the abuse of discretion standard on appeal needs a "hard look" seems a bit undeveloped and rates a "meh" in our opinion.

The fourth, and best point, is that courts ought not simply let the jury figure it out and then fix the verdict if they get it wrong. I first ran into the issue in a trace benzene case. Admitting that the plaintiff's exposure to benzene at my client's facility was considerably less than his EPA and OSHA estimated background dose the plaintiff's expert opined that "naturally occurring benzene has a different electron resonance orbit than synthetic benzene" and that only man-made benzene had the toxic electron resonance orbit. Having a chemistry degree undergrad came in handy (though a BS-O-Meter would work as well), but not handy enough. The judge refused to exclude the expert saying he'd "take care of it" if the jury didn't. Needless to say a cost-of-defense settlement was reached. So hooray for the conclusion that "in an adversarial system employing lay fact finders there are multiple reasons for imposing a reliability filter on expert evidence."

Our main gripes are with footnotes 82 and 105. In footnote 82 the authors write: "The idea that a regulatory agency would make a carcinogenicity determination if it were not the best explanations of the evidence, i.e., more likely than not, is silly." First, the idea that critical thinking and regulatory agencies subject to political whims make strange bedfellows ought not be surprising. Second, the idea that "specific causation is not scientific" fails both to acknowledge the usefulness of biomarkers and that the very same probabilistic approach to causal inference that works for general causation works for specific causation. Finally, sneaking in reasoning to the explanation as a proxy for "more likely than not" ignores the method's provenance. It is rather a "guess" awaiting a test.

Footnote 105 quibbles with the role of statistics in all this (quoting Haack approvingly) "as the phrase 'tested or verified' suggests, what this really says is that the plaintiff's experts have produced no statistically significant evidence supporting the claim that Parlodel increases the risk of postpartum stroke." No, what the cited case says is that what the plaintiff's experts produced was highly likely to have been wrong. The point of the statistical test is to ask how likely it is that your hypothesis rejecting the null hypothesis is wrong. If you remember that all we know, as we make our way through Galileo's dark labyrinth towards the truth, is what isn't so you'll appreciate the difference.

All in all it's a good read and its conclusion, that courts indeed ought to filter out those claims that can never be proven, makes it well worth the time invested.

1% of the Fault to Plaintiff, 2% to the Negligent Tortfeasor and 97% Percent to the Intentional Tortfeasor Means 99% of the Liability to the Negligent Tortfeasor

Huh? That's what we said.

Because the civil law (at least in the Court of Appeals of Indiana) is all about the Benjamins, a court has found that an ever so slightly negligent (2%) business owner needs to pay for 99% of the harm caused by a murderer. Citing the Restatement (Third) of Torts. Section 14, a public policy in favor of adequately compensating the wronged (though, without discussion, they may be inadequately compensated thanks to their own (1%) wrongs) and the difficulty murderers have in procuring insurance to cover their rampages, the appellate court in Santelli v. Rahmatulla found that the Restatement provides a handy way of escaping Indiana's reform of its joint and several liability rule. File this one under "Redistributive Justice".

 

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Discretizations

Discretizations

When it comes to lung cancer, keep your chickens close but keep your flock closer.

"They've internalized their own confusion": watch this video if you want to understand the difference between humble falsificationist evidence-based science and the authoritarian "because I say so" approach adopted by the 1st Circuit in Milward.

Antibiotic use in children less than six months old is strongly associated with the subsequent development of asthma, especially in those without a family history of asthma, and the greater the intake of antibiotics the greater the odds of developing asthma.

Attacks on randomized controlled trials (RCTs) miss the point.

A new paradigm for cancer prevention, indeed.

 

Duty, Palsgraf, The Hand Rule and Public Interest: This Take Home Case Has It All

 

IN RE ASBESTOS LITIGATION, JANINE McCOY and MARVIN McCOY Limited to: PolyVision Corp., Superior Court of Delaware, New Castle County

Turning, ultimately, on the peril of limitless liability the Delaware court in McCoy reasoned that Pennsylvania, which has yet to weigh in on the issue, would not find a duty to the spouse of an employee allegedly grievously injured as a result of being exposed to asbestos dust carried home on her husband's work clothes.

First, on the issue of foreseeability, Palsgraf made an appearance (just long enough to introduce the relationship test of the limits of duty) but it merely cancelled out other opinions taking a limitless view of foreseeability. Next up was the Hand Rule comparing the expected value (loss) of an injury to the cost of prevention. Noting that extending duty to a spouse would necessarily imply extending a duty to everyone her husband might foreseeably have come in contact with the court found the burden of prevention sought to be imposed too high. Finally canvassing the states neighboring Pennsylvania, those likely to follow similar precedents and reasoning, the court found that 4 out of 5 refused to extend duty from employee to spouse.

And so the court came to the right answer though, as we keep saying, quantitative risk assessment as a proxy for substantial factor analysis reaches the same conclusion but in, we think, a cleaner and more predictable fashion.

 

 

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U.S. Supreme Court Holds LIA Preempts Asbestos Friction Product Claims

All members of the court in Kurns v. Railroad Friction Products Corp., et al. felt bound by stare decisis (in this case Napier) to hold that the petitioners' design defect claims against the manufacturers of asbestos-containing friction products used in locomotives were preempted by the Locomotive Inspection Act (LIA).  Nevertheless, the case produced both a concurrence and a dissent.   The debate revolved around the question of whether or not a "failure-to-warn" claim is 1) a  subset of design defect; 2) subsumed within the power of the LIA to require or prohibit the use of a particular product as it would thus have the power to make use of the product conditioned upon warnings; or, 3)  an independent cause of action separate from design defect and thus outside the field preempted by LIA.

The majority, relying on the following from the Restatement (Third) of Torts:  Products Liability:

A failure-to-warn claim alleges that a product is defective 'when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, . . . and the omission of the instructions or warnings renders the product not reasonably safe'

held, "[t]hus, the 'gravamen' of petitioners' failure-to-warn claims 'is still that [plaintiff] suffered harmful consequences as a result of his exposure to asbestos contained in locomotive parts and appurtenances.'"  In other words, a complaint about a lack of a warning is a complaint about the product that lacks it so that the LIA's control over any product that went into a locomotive necessitates a finding of preemption.

Justice Kagan concurred writing "... if an agency has the power to prohibit the use of locomotive equipment, it also has the power to condition the use of that equipment on proper warnings."  She concluded "[a] nd because the agency could have required warnings about the equipment's use, the petitioners' failure-to-warn claims, no less than their defective-design claims, are preempted under Napier."  Her decision turned on the implicit power of the agency to direct how products were to be used given that it had the power to which products were to be used.

In a dissent joined by Justices Ginsberg and Breyer, Justice Sotomayor reasoned " a product may be flawlessly designed and still subject its manufacturer or seller to liability for lack of adequate instructions or warnings."  Accordingly she concluded "[r]ather, the 'gravamen' of these claims is that petitioners' decedent . . . could have avoided the harmful consequences of exposure to asbestos while repairing precisely the same locomotive parts had respondents cautioned him, for example, to wear a mask."  Their notion then is that preemption ends at the product itself and does not extend to the information necessary for its safe use.

The majority responded in a footnote as follows:

A failure-to-warn claim imposes liability on a particular design of locomotive equipment unless warnings deemed sufficient under state law are given.  This duty to warn and the accompanying threat of liability will inevitably influence a manufacturer's choice whether to use that particular design.

Warnings then are seen by the majority as inseparable from a product's design.

So is this a big deal or not?  On the one hand, the idea that warnings and instructions, the information component if you will of a product, are just part of a product's design (which in turn incorporates the common law's regulatory scheme, such as it is) and not a foundation for an independent cause of action sounds fairly revolutionary.  But upon reflection it not only makes a lot of sense, it's unlikely to have much impact since claiming that a product's design is defective because its warnings are inadequate ought not require any proof beyond the usual in failure-to-warn cases.  On the other hand, in those cases where courts have found preemption but held that warnings were somehow separate from the product specified by the government so that plaintiffs' claims survived, this could be a very big deal indeed.

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There's Something About Nevada

After getting hammered in quick succession for $500 million, $162 million and $90 million worth of punitive damages in three cases involving a total of just five plaintiffs, Teva settled its Nevada hepatitis C (HCV) / Propofol claims.  The price tag was just past a quarter billion dollars. 

So what happened?  Teva's generic Propofol wasn't defective.  It didn't leave the factory contaminated with HCV.  Instead the claims arose out of the following findings of the CDC:

Inappropriate reuse of syringes on individual persons and use of medication vials intended for single-person use on multiple persons was identified through direct observation of infection-control practices at clinic A (Desert Shadow Endoscopy Center). Specifically, a clean needle and syringe were used to draw medication from a single-use vial of propofol, a short-acting intravenous anesthetic agent. The medication was injected directly through an intravenous catheter into the patient's arm. If a patient required more sedation, the needle was removed from the syringe and replaced with a new needle; the new needle with the old syringe was used to draw more medication. Backflow from the patient's intravenous catheter or from needle removal might have contaminated the syringe with HCV and subsequently contaminated the vial. Medication remaining in the vial was used to sedate the next patient.

and the final report of the Southern Nevada Health District which includes the following graphic demonstrating how the clinic contaminated the Propofol:

The vials were clearly labeled for single use and the warning was further emphasized when reports surfaced that some were being used for multiple doses.  Discovery apparently revealed that the larger vial size helped reduce manufacturing costs. 

Okay, so Teva was found liable for not guarding against the (allegedly) foreseeable blatant disregard of its warning labels and of standard vaccination administration safety procedures by the endoscopy clinic.  Nevada seemingly has an expansive view of duty and its jurors a limitless view of foreseeability.  But what explains the repeated mega punitive verdicts?  Every mass tort has its outliers but we've not seen anything like this.  If we hear any scuttlebutt we'll let you know.

Along the way it certainly looked like the cases were going well for Teva.  For example, it made some good law at the Nevada Supreme Court which we've mentioned previously.  Specifically the court recognized that a rule preventing a defendant from discussing other possible causes (unless its experts are willing to testify that such alternate cause(s) were, in reasonable medical probability, the cause in fact of plaintiff's illness) would work a great injustice.  As we've said before the effect of such a rule would be to admit the most speculative claims of causation while excluding the most reasoned and sober assessments of causal attribution.

Why did Teva settle?  Again, we're not privy to any inside information but hazard the following guess.  The recent tendency of the Nevada Supreme Court to affirm eye-popping jackpot verdicts weighed heavily in Teva's analysis.  Usually when you get a huge judgment before a supreme court, as Teva had here, you're pretty confident that at the very least the outlier award will be substantially reduced.  Yet in Nevada these days such payouts are quite likely to be affirmed. In any event we're betting that the Nevada civil courts will be busy and that tort claims arising out of the spread of pathogenic bacteria, viruses and prions will increasingly be the focus of the plaintiffs' bar.

When Man's Designs Don't Include Nature's

Does powdered infant formula (PIF) contaminated with Cronobacter sakazakii nee Enterobacter sakazakii constitute a design defect? The district court in The Security National Bank of Sioux City, Iowa v. Abbott Laboratories thinks so.

Creating (we think) a design defect dichotomy the court distinguished between "intended design", here PIF designed to specification but without bacteria and (apparently) "unintended design" - PIF designed to specification but with bacteria. Unintended design defects sound suspiciously like manufacturing defects since the bugs are picked up in the manufacturing process but the court held otherwise. Turning defendant's argument that bacterial contamination is common in any food not specifically sold as sterile into an assertion that the PIF was thereby meant incorporate E. sakazakii the court wrote: "[a]ny assertion that Defendant's intended design included the presence of E. sakazakii strains credulity."  

Hammering away at defendant's claim that the microbial world's ancient and relentless assault on humanity and its works aren't part of the design of PIF the court continued: "the implication is clear: their product is intended to contain E. sakazakii, as well as other potentially harmful bacteria. First, if 75% of a product does not contain a bacteria and 25% of a product does, elementary statistics dictates that the 75% without the bacteria constitutes the norm while the 25% with the bacteria constitutes a deviation therefrom. Second, a common defect, such as the persistent contamination of a food product with bacteria, if generally unknown and proven harmful, should increase a manufacturer's total liability, rather than eliminate it." Finally, holding that plaintiff's proposed alternate designs of adding a biocide to the unintentionally designed but on spec PIF, or of adding water so that PIF becomes IF, the court concluded that plaintiff's design defect claims survived defendant's motion to dismiss.

So, when a food company's designs don't include E. sakazakii's does that constitute an "unintended design defect"? Even when its product is on spec? And is adding e.g. antibiotics or soaps or chlorine to PIF a valid alternate design of PIF? How about claiming that PIF can be changed to IF without somehow losing the P?

A half dozen other claims by plaintiff also survived the motion to dismiss including manufacturing defect and breach of implied warranty. Those we get but the design defect claim is a head-scratcher. Perhaps the court didn't understand that we're all in continuous contact with potentially harmful bacteria. In fact, we're full of and crawling with countless numbers of them though we only notice if say one that lives peacefully on our skin winds up in our lungs. Or maybe the court understood and is imposing a duty to incorporate nature's designs into our own. We'll let you know if further light is shed on the matter.

For more about PIF, E. sakazakii and the devastating meningitis that caused severe and permanent brain damage in plaintiff see this very informative PowerPoint from the CDC: "Enterobacter sakazakii meningitis and death associated with powdered infant formula." and last December's press release from the FDA, "Investigation of Cronobacter Bacteria Illness in Infants".

Parallel, Not Perfect

Walker v. Medtronic is another new case interpreting Riegel. This time the device failed utterly (given the undisputed evidence that the plaintiff's decedent died when an implantable pain pump delivered a massive overdose). The case hinged on whether the (in)accuracy of the (over)dose administered, in this case the consequence of a complete failure, constituted a variance from a performance standard set out in the pre-market approval (PMA) so that a state tort claim could proceed.

Holding (essentially) that the FDA mandates design/manufacturing process fealty rather than perpetual operational accuracy, the majority recognized that a product made to the FDA's exacting standards may fail nonetheless and that in such circumstances a parallel state claim cannot lie.

The dissent sought to make the performance standards basically a guarantee confusing, we think, accuracy with perfection.

Props to the majority for the Mr. Spock reference: "the benefit to the many ... outweighed the cost to the few..."

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Plaintiff Avoids Preemption and Twombly in Parallel

The Fifth Circuit has held in Bass v. Stryker  that plaintiff's claim against the manufacturer of an allegedly defective hip replacement device is not preempted by the Medical Device Amendments of 1976 to the FDCA, and that his complaint satisfies Twombly.  Because plaintiff's allegation "paralleled" an FDA manufacturing practice and asserted that the "good" practice was not followed, resulting in a device that did not work as contemplated causing his injuries, the lower court's dismissal of plaintiff's manufacturing defect, negligence and implied warranty claims was reversed.  

The manufacturing practice at issue involved ensuring that the "final wash" was not contaminated so that the device would not become "adulterated". Were the wash to be so contaminated the microbes could set up shop on the device, in this case the ceramic shell, and prevent the bony ingrowth that would otherwise help secure the implant. Some months before this particular device was implanted the FDA had warned the manufacturer that it had not implemented necessary changes to the final wash portion of its manufacturing process and further had failed to verify that the wash met the standards for bioburden. Though Bass had not specifically plead that his device (which had been recalled) was contaminated, nor that doctors removing it had found evidence of an infectious process, the pleading was nevertheless sufficient to put Stryker on notice as to just what it was that plaintiff was claiming.

The bottom line is that if a plaintiff can find a way to turn a design defect into a manufacturing defect (e.g. claiming the device as manufactured was contaminated rather than claiming that the design failed to include an anti-bacterial agent) by finding a potential for variance in the manufacturing process, and then plead a plausible nexus between the resultant device and her injury, she ought at least be able to make it to the discovery stage.

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Dismissed With Prejudice

Today we filed this responsive brief in the United States Supreme Court. Question: Is a summary judgment dismissal necessarily with prejudice? Who would have thought this would (maybe) make it to SCOTUS? We’ll keep you posted should an order nunc pro tunc catch their eye.

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Probability For Thee, Mere Possibility for Me

And that's exactly as things ought to be.  When I got to Beaumont, TX, one of the first and most notorious of all judicial hell holes, I was appalled by what this lawyer/biochemist saw. Plaintiffs' experts were willing to testify to anything (for a fat fee) and were being allowed to do so as long as they promised to say that e.g. it was more probable than not that the plaintiff's pancreatic cancer was caused by formaldehyde from plywood in his trailer. Meanwhile, a defense expert, willing only to say that plaintiff had multiple risk factors for pancreatic cancer (like smoking) far more potent than formaldehyde and that plywood was at best a negligible factor, was not allowed to testify about any possible alternative causes at all since she refused to swear that any single possibly causative factor more likely than not actually caused plaintiff's cancer. The result was that plaintiff's experts, almost all of the Collegium Ramazzini-variety who passed the red-face test only because they believed that essentially every cancer was the result of exposure to man-made toxicants, could testify to anything, while more measured and critical-thinking experts could not testify at all.

"Causation must be pr oven on a more likely than not basis" said one judge over and over, and no argument to the effect that plaintiff bore the burden, and not the defendant, would change his mind. The result, I'm sorry to admit, was that we were forced to find experts as willing to sing whatever song paid for their supper as those employed by plaintiffs. Whatever the result it bore little relationship, if any, to our quest for truth.

The good news is that courts are starting to get it - that there are credentialed nitwits and judicial polymaths - and that the latter can see through the logical fallacies of the former though they haven't an alphabet soup of letters beyond J.D. Take Benkendorf v. Advanced Cardiac Specialists Charted, for example.

"Requiring defense experts to testify based only on reasonable medical probabilities would effectively prevent defendants in many cases from presenting testimony regarding causation unless their experts could declare that a particular alternate cause more probably than not was the cause of plaintiff's injury." The "inequities would abound" were a court to rule otherwise. "[W]e agree with the majority of jurisdictions that have addressed the issue and hold that an expert witness called by the defense to testify about causation ... may testify about 'possible' causes of the plaintiff's injury. A defendant ... need not prove another cause for plaintiff's injury, but may ... testify as to alternative causes tending to undercut the plaintiff's contention that the defendant's alleged negligence more probably than not caused the injury."

Benkendorf is a med/mal case but nails the burden of proof of causation. Tomorrow (assuming we get our response out to SCOTUS on something else) a Bayesian smackdown on why false positives grotesquely outnumber the false negatives in toxic tort / mass tort litigation.

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Discretizations

The conjunction paradox isn't one and doesn't require new standards of proof; rather, it's evidence that the asymmetry in the law markedly favors false positives, whatever some may say.

Cancer-causing H. pylori might find its way into you by hitching a ride in food borne yeasts.

Blame for obesity: BPA vs BUG.

The evidence that hormone replacement therapy "causes" breast cancer isn't as strong as you think.

Occupational exposure to animals: evidence for a causal link with cancer mounts.

Mea Culpa

I authored an article on Texas' standard(s) for proof of causation that appeared in this week's Texas Lawyer and it contains an error. In discussing Merck v. Garza I somehow managed, during the process of editing the article down to the target word count, to associate the citation from the original appellate court opinion with the decidedly different conclusion reached by the Texas Supreme Court to which I was referring. My bad.

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"... Daubert Relevancy is the Sentry That Guards Against the Tyranny of Experts"

The United States Court of Appeals, First Circuit, has delivered an opinion about the duty borne by trial courts to keep out flawed analyses by credentialed experts that is as keen in its reasoning as it is sharp in its prose. It's "Samaan v. St. Joseph Hospital".

Have you ever despaired of explaining that a 50% increased risk doesn't mean that half of  those exposed are going to come down with the ailment associated with the elevated risk? Or that a big increase in a tiny risk rarely has anything to say about causation? Take a copy of Samaan with you the next time it comes up and have the following to hand:

" When a person's chances of a better outcome are 50% greater with treatment (relative to the chances of those who were not treated), that is not the same as a person having a greater than 50% chance of experiencing the better outcome with treatment. The latter meets the required standard for causation; the former does not.

To illustrate, suppose that studies have shown that 10 out of a group of 100 people who do not eat bananas will die of cancer, as compared to 15 out of a group of 100 who do eat bananas. The banana-eating group would have an odds ratio of 1.5 or a 50% greater chance of getting cancer than those who eschew bananas. But this is a far cry from showing that a person who eats bananas is more likely than not to get cancer. Even if we were to look only at the fifteen persons in the banana-eating group who did get cancer, it would not be likely that any particular person in that cohort got it from the consumption of bananas. Correlation is not causation, and a substantial number of persons with cancer within the banana-eating group would in all probability have contracted the disease whether or not they ate bananas."

And then there's this:

"Many aspects of science are a mystery to laymen without the aid of experts. In the world of the blind, the one-eyed man is king; and Daubert relevancy is the sentry that guards against the tyranny of experts. As the gatekeeper, the trial judge has the duty to insulate the jury from expert testimony when reliance on authoritative studies and methods threatens to mask the lack of an adequate fit. An expert might be able to testify on the phases of the moon to prove that it was dark by a particular time, but he could not offer the same testimony to prove that a person was likely to act in an unusual manner on that night."

But best of all and a bit earlier on in the opinion the court makes it clear that evidence, rather than mere conjecture, is required before a citizen is relieved of his property:

"The reliable foundation requirement necessitates an inquiry into the methodology and the basis for an expert's opinion. To perform the required analysis, the district court must consider a number of factors, including but not limited to "the verifiability of the expert's theory or technique, the error rate inherent therein, whether the theory or technique has been published and/or subjected to peer review, and its level of acceptance within the scientific community." Ruiz-Troche, 161 F.3d at 81. Given the nature of this analysis, the expert's methodology is commonly the "central focus of a Daubert inquiry." Id.

The second requirement has attracted less attention. This requirement seeks to ensure that there is an adequate fit between the expert's methods and his conclusions. See Daubert, 509 U.S. at 591. This prong of the Daubert inquiry addresses the problem that arises when an expert's methods, though impeccable, yield results that bear a dubious relationship to the questions on which he proposes to opine." (Emphasis added).

So,  how to reconcile Saaman with Milward? I'm afraid it can't be done.

 

 

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Discretizations

Trials and Errors and Milward v. Acuity

Today the U.S. Supreme Court denied U.S. Steel's petition for writ of certiorari in Milward v. Acuity. As a result plaintiffs' expert is now free to testify about his untested and in fact untestable hypothesis.  It's a shame because the First Court of Appeals has apparently lost sight of what science, at least reliable science, is all about.

Consider "Trials and Errors:  Why Science is Failing Us".  The article describes what was deemed the shocking failure of torcetrapib - a drug designed to prevent so-called "good" cholesterol (HDL) from converting into "bad" cholesterol (LDL).  Noting that "[t]here was a vast amount of research" supporting the proposition that increasing the HDL:LDL ratio would prevent coronary artery disease, and given that "the cholesterol pathway is one of the best-understood biological feedback systems in the human body", scientists assumed that they knew how torcetrapib would act and that its effect would be positive.  Instead, "the drug appeared to be killing people."

Rather than a failure of science the story of torcetrapib should be viewed as a triumph, at least so long as science is viewed as a method for subjecting big ideas to the acid bath of skepticism rather than the hatching of seemingly clever notions.  Milward, by allowing an expert to base his causation opinion on nothing more than a plausible hypothesis consisting of a proposed biologic mechanism far less well understood than that of the cholesterol pathway, embraces the big idea view of science.

The debate is an old one but one in which common law countries have generally sided with the scientific method over mere idealism.  Perhaps it has something to do with the experience of French and English bridge designers.  The early French suspension bridges had an unfortunate tendency to collapse despite being beautiful whereas the English versions tended to be ugly but sturdy.  For the French designers the thought was "it must stand because it is so beautiful".  For the English the idea was "it must stand or I shall be fired". 

The opinions of experts should be no less tested and no less reliable than bridges as both have so much riding on them.

It's Not That The Analytical Gap Was Too Wide

It's that analytical gaps are bridged by evidence and there was no evidence that therapeutic doses of Tylenol cause cirrhosis of the liver. Rather than simply saying so the court in Ratner v. McNeil-PPC, Inc.  veered into the always unenlightening analytical gap width assessment:

"The plaintiff did not put forward any clinical or epidemiological data or peer reviewed studies showing that there is a causal link between the therapeutic use of acetaminophen and liver cirrhosis. Consequently, it was incumbent upon the plaintiff to set forth other scientific evidence based on accepted principles showing such a causal link. We find that the methodology employed by the plaintiff's experts, correlating long term, therapeutic acetaminophen use to the occurrence of liver cirrhosis, primarily based upon case studies, was fundamentally speculative (see Lewin v County of Suffolk, 18 AD3d 621), and that there was too great an analytical gap between the data and the opinion proffered. We emphasize that when an expert seeks to introduce a novel theory of medical causation without relying on a novel test or technique, the proper inquiry begins with whether the opinion is properly founded on generally accepted methodology, rather than whether the causal theory is generally accepted in the relevant scientific community."

Why not just say "plaintiff's experts have no evidence that their theory is true"? In the court's defense it was struggling to reconcile its ruling with Zito v Zabarsky in which it had previously held that in the case of a "new drug" plaintiffs need not wait for evidence (e.g. epidemiology) as otherwise:

" [a] strict application of the Frye test may result in disenfranchising persons entitled to sue for the negligence of tortfeasors. With the plethora of new drugs entering the market, the first users of a new drug who sustain injury because of the dangerous properties of the drug or inappropriate treatment protocols will be barred from obtaining redress if the test were restrictively applied.

(I am here reminded of a benzene / CML case I once tried in which plaintiff's counsel in closing bellowed "Mr. Oliver says that not enough workers have gotten CML to prove benzene is the cause of their cancers. I hope when it's his turn to speak that he answers this question: How high must the bodies be stacked before his client will admit that benzene was the cause?")

Anyway, as you can see the court was confronted with its prior opinion in which it had held that a well conceived hypothesis, though lacking utterly any evidence to support it, was enough to get a "new drug" case to the jury. Thus its effort to distinguish the two cases via "Tylenol is not a new drug" (more to the point would have been "there's been ample opportunity to test  your theory via retrospective epidemiological studies and yet still you have no evidence") and thereafter a retreat into the bushes of "analytical gaps".

Karl Popper said that science proceeds by conjecture and refutation. You think up a theory about how some aspect of nature works, determine what predictions follow from it, and then check  to see if the predictions hold up. That last part is what's called evidence. Without it you're left with nothing but a more or less educated guess; and that isn't enough to warrant depriving a citizen of life, liberty or property. That's what Daubert was all about.

Finally, does it look to you like "deduction" has a different meaning in New York? Here it seems to refer simultaneously to the method  by which a general rule is induced from observations and the method by which a causal association is inferred from the rule you've just induced, thus:

 "Generally, deductive reasoning or extrapolation, even in the absence of medical texts or literature that support a plaintiff's theory of causation under identical circumstances, can be admissible if it is based upon more than mere theoretical speculation or scientific hunch (see Zito v Zabarsky, 28 AD3d at 46; see also Black's Law Dictionary [9th ed 2009] [defining "extrapolation" as "(t)he process of estimating an unknown value or quantity on the basis of the known range of variables" and "(t)he process of speculating about possible results, based on known facts"]). Deduction, extrapolation, drawing inferences from existing data, and analysis are not novel methodologies and are accepted stages of the scientific process.

For example, in Zito v Zabarsky (28 AD3d 42), this Court expressly recognized that extrapolation or deduction is warranted in instances where the theory pertains to a new drug."

 Let me know. Thanks.

 

 

What Do Reputable Scientific Organizations Consider To Be Evidence?

The new IOM report, "Breast Cancer and the Environment: A Life Course Approach", again emphasizes the difference between how scientific panels go about making a causal inference and the approach too often approved of by credulous judges often insecure about their own ability to think critically and mesmerized by the jargon-laden pronouncements of credentialed experts. Beginning on page 82 under "Hierarchy of Studies" and followed by "Categories of Evidence" the report does a great job of detailing what counts as evidence and the methods and criteria used by organizations like the International Agency for Research on Cancer, the National Toxicology Program, the World Cancer Research Fund / American Institute for Cancer Research in going about collecting, assessing and weighing evidence when making causal judgments. They even put together a helpful summary of the classification systems (see Appendix C, "Classifications Systems Used in Evidence Reviews" at page 312).

Here are a couple of takeaways: (1) "The criteria aim to be explicit about the weight, or relative importance, given to studies in humans and in animals or other experimental systems"; and (2) "Strong and consistent positive epidemiologic evidence in rigorously conducted studies is prima facie evidence that the substance is a risk factor." You will quickly note upon reviewing the summary of systems of causal inference that none support anything like the notion embraced by the court in Milward v. Acuity that an expert weighing a subset of the data (each piece of which is either weak, irrelevant or inconsistent) upon the scales of his personal scientific judgment can by "reasoning to the best explanation" reliably reach a causal inference  - especially in the complete absence of any epidemiological evidence to support it. Indeed the "atomization" of evidence decried by the Milward court and those in the "public health movement" who promote mass tort litigation is exactly what IARC, IOM, NTP, EPA and WCRF/AICR do - they assess each piece of evidence, they do it transparently, they do it according to rules laid down before they even go looking for the evidence and then they weigh what's left; again, according to weighting systems that are explicit, consistent and established before the first piece of evidence is examined.

The idea that knowledge comes from scientists taking a "holistic approach to the data" and applying their personal judgment to it is, to be blunt, hooey. That may be a way to arrive at a testable conjecture but without the conjecture passing a test of its predictive power (e.g. a rigorous epidemiological study) it remains nothing but a bald, personal opinion with no foundation beyond the ipse dixit of the expert who induced it.

 

Discretizations

Discretizations

Discretizations

The Reference Manual on Scientific Evidence: Third Edition: Good Grief!

Well, the Reference Manual on Scientific Evidence: Third Edition is out. And the fix is in.

Think we exaggerate? How about this little gem from the Preface: "Judges and juries, however, must consider financial conflicts of interest when assessing scientific testimony. The threshold for pursuing the possibility of bias must be low. In some instances, judges have been frustrated in identifying expert witnesses who are free of conflict of interest because entire fields of science seem to be co-opted by payments from industry"?

Or how about the first section of the first chapter of the Manual: "A. Atomization"? Citing our least favorite case, Milward v. Acuity, the Manual frowns on the effort of courts to examine the premises, and the evidence allegedly supporting those premises, of an expert when determining whether his causal inference is warranted. Noting, very slyly and without disclosing their demand for transparency and accountability, that certain well known and respected authorities have concluded that ultimately the determination of causation is a matter of scientific judgment "reflecting the weight of the evidence", the Manual chastises those who might cock an eyebrow when it turns out that none of the "evidence" proffered by an expert actually supports his opinion. What duties would be left to a gatekeeper obliged to accept the mere ipse dixit of a well credentialed academic? The Manual, unsurprisingly, doesn't say.

Worse yet, and indicative of who, and what cause, was behind the effort, the Manual goes on to cite the new-ish Milward three more times. Once for the proposition that the unproveability of a theory is proof of the theory; once to support the rubber stamping of an expert's personalized and unexamined - weighing in the scales of his scientific judgment - "methodology"; and, once to reject the idea that statistical significance testing - the "it might be so" hurdle for hypothesis generation from statistics - is any business of federal judges.

The first chapter tellingly concludes that "there are serious concerns about whether ... the guidelines have resulted in trial judges encroaching on the province of the jury to ... judge the overall credibility of  ... scientific theories." We thought the whole point of Daubert was to ensure a better approximation of the truth by at least limiting the theories to be considered by lay juries to those that have a decent chance of being true. Guess not.

Anyway, the next chapter, as with the Second Edition, goes on to roll its eyes at the Popperian view of science embraced by the court in Daubert. Its author, again, is "Peak Oil" advocate David Goodstein. More on that later.

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The Sixth Circuit (almost) Gets Substantial Factor Causation

In Moeller v. Garlock Sealing Technologies, LLC the 6th Circuit held that while the decedent's exposure to the defendant's gaskets "may have contributed to his mesothelioma, the record simply does not support an inference that it was a substantial cause of his mesothelioma. Given that the Plaintiff failed to quantify [decedent's] exposure to asbestos from [Defendant's gaskets] and that the Plaintiff concedes that [decedent] sustained massive exposure to asbestos from [other] sources, there is simply insufficient evidence to infer that [Defendant's] gaskets probably, as opposed to possibly, were a substantial cause of [decedent's] mesothelioma... On the basis of this record, saying that exposure to [Defendant's] gaskets was a substantial cause of [decedent's] mesothelioma would be akin to saying that one who pours a bucket of water into the ocean has substantially contributed to the ocean's volume. Cf. Gregg. v V-J Auto Parts, Col, 943 A.2d 216, 223 (Pa. 2007)."

So what's the problem? The problem is that the court is not asking whether the exposure in question created a substantial risk - one that may have been (though we'll never know because there were other possible sufficient causes) the cause of plaintiff's injury. No, the court is asking whether the exposure was likely to have been the "actual cause" of plaintiff's injury. That's made clear when the court writes: "Substantial causation refers to the probable cause, as opposed to a possible cause". Thus, it's not an inquiry as to the conduct (i.e. did Defendant produce more than a de minimis risk) but rather an inquiry as to the amount of the exposure to Defendant's product relative to other exposures.

For defendants then, who increasingly face a litigation environment in which their product contributed a bucket of water into an ocean the size of a bathtub, a few more victories like Moeller v. Garlock threaten to utterly undo them.

Hat tip Nina Webb-Lawton

Discretizations

Should Sauce For The Technocrat Be Sauce For The Expert Witness?

If an expert, or a panel of experts, renders an opinion in the face of considerable uncertainty ought she, or they, be subjected to liability if their opinion turns out to be wrong? When scientists in Italy got earthquake advice wrong, and were sued for damages and prosecuted for manslaughter, scientists from around the world demanded that legal systems understand just how little even experts know about how the world works and how tentative is their knowledge, and how often wrong are even the wisest among us. (Socrates must be smiling). See "Scientists On Trial: At Fault?"

Well, if experts shouldn't be subjected to liability when they opine about cutting edge and uncertain science why should defendants be subjected to liability for claims founded upon the very same unproved and highly uncertain opinions of expert witnesses? Maybe if expert witnesses could be fined or incarcerated for opinions that later turn out to be wrong we'd see a lot more humility, and honesty, among the experts who ply their trade down at the courthouse.

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A Cookie Jar For The Plaintiff's Bar?

That's what many have concluded about the Restatement (Third) of Torts: Liability for Physical and Emotional Harm. When one of its reporters co-authored "The New Restatement's Top 10 Tort Tools" for "Trial" magazine the worst fears of those who had fretted that the new Restatement wasn't a restatement at all but rather a stealth effort to unleash new waves of litigation seemed to have been confirmed. Now a new law review article, "Reshaping the Traditional Limits of Affirmative Duties Under the Third Restatement of Torts", by Victor E. Schwartz and Christopher E. Appel, lays out the case.

Especially eye-opening is the discussion of the attempt to impose liability for insufficient risk reduction; and it doesn't just apply to "Bad Samaritans". An affirmative duty of care, the breach of which being a tort, may now be triggered by contracts and promises "which, if [the Restatement is] adopted, would likely [] lead to liability in situations in which a duty has never before been recognized." Of note to insurers is the explicit intention to impose a duty on anyone engaged in risk/loss prevention efforts. Not content with discouraging insurance companies from helping their insureds avoid accidents the Restatement proceeds to make employers think twice before running health screening for its employees to demonstrate they're not at risk of occupational illness.

And how can an insurer or an employer or any would-be Good Samaritan avoid undertaking such duties? It's not clear that they can, write the authors, noting the Reporters' Note to Section 42 tries to cut off Good Samaritans at the pass: "Statements denying an undertaking or about the limited purpose of the inspection must be read skeptically as they are not provisions that are bargained for by adversaries acting at arm's length and often are inserted only to diminish potential liability to third parties who are not parties to the contract."

Schwartz and Appel conclude that "... the new Restatement takes the rule of duty through undertaking in precisely the wrong direction. Public policy should encourage undertakings that help promote public safety and education, and not chill such action through an expansion of duty in tort law." Of course, that assumes that one purpose of the new Restatement was the common good. Oh well.

 

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"The Cost to the Health of Our Microbial Ecosystems"

Gina Kolata has another good read at the NYTimes in "The New Generation of Microbe Hunters". The word, as you can see, is quickly getting out; the old ways of thinking about the determinants of human health are crumbling as the discovery that we are "super-organisms", more bacterial than human - at least from a genetic perspective, sweeps away old notions about what makes us sick, what keeps us healthy and even what (and maybe who) we are.

For other dispatches from the revolution you might want to read about just how big a deal this is, how much we know, how much remains to be understood and the promise of biotherapeutics; or maybe, since there's a little Gilgamesh in each of us, how  changing the bacteria in the gut of mice makes the rodents live significantly longer;  then there's a dysregulated microbiome and rheumatoid arthritis; new insights into how H. pylori causes gastric cancer; and gut microbes can cause cancer of the liver and breast (in mice anyway); and changing the gut microbiota to treat type 2 diabetes and, and, and ... There's a torrent of literature but that'll give you an idea what's out there and what's coming.

None of that is to say "Eureka!" they've found the answer. Likely (as it's wise to hedge bets) the causation onion has many layers still uncovered. No, the point is twofold. First, the 40 year old idea championed by public health advocates pushing what they call social, or environmental, justice - that much if not most human suffering is due to bad industrial chemicals or the bad habits inculcated in consumers by nefarious corporations bent on selling them things they don't want or need - was never sound but now it's just silly. Second, if you've been paying attention, you'll understand that an awful lot of illness and suffering has been caused by stuff nobody, we presume, ever fretted about. But who knows? Maybe somebody somewhere has the disrupted microbiome version of the Sumner Simpson Papers. Wouldn't that be something?

Havner: Now We're Really Confused

The Texas Supreme Court just decided Merck v. Garza. The relatively short opinion rolls along (1) reaffirming Havner; (2) apparently adding the further requirement of a second well done epidemiological study "statistically significant at the 95% confidence level" that shows a doubling of risk; (3) rejecting the "totality of the evidence" ipse dixit of plaintiff's expert; but then suddenly (4) utterly confounding us by holding "when parties attempt to prove general causation using epidemiological evidence, a threshold requirement of reliability is that the evidence demonstrate a statistically significant doubling of the risk". What?!

The whole purpose of the "doubling of the risk" requirement had been, we thought, to ensure that when a plaintiff has nothing but probabilistic evidence such evidence must actually support a "more likely than not" causal inference as to her specific illness. There are numerous agents that produce small effects (i.e. relative risks less than 2.0) and which are nevertheless unquestionably causative of human disease. Hopefully, the court meant "specific" where it wrote "general" regarding risk doubling.

Yet there's another problem on the very next page. Apparently courts are now to "examine the design and execution of epidemiological studies using factors like the Bradford Hill criteria to reveal any biases that might have skewed the results of the study." Again: What?! We thought (and we're pretty sure we're right) that Hill's list of factors were his way of assessing a given claim of general causation. And anyway, that's not how you look for bias. This is how you look for bias: "Excess Significance Bias in the Literature on Brain Volume Abnormalities".

In sum we liked, of course, the court's conclusion that when each piece of plaintiff's supposedly supportive evidence is flawed "a plaintiff cannot prove causation by presenting different types of unreliable evidence." Yet, recognizing that causal inference is hard (nearly maddening sometimes) and that statistical inference is complicated and counterintuitive, we wish the court had done a better job on this one. The deviations from standard analysis will only support those who complain that the current court is "merely results oriented".

Discretizations

An Early Return Indeed

For more evidence that Milward v. Acuity is “one of the most significant toxic tort cases in recent memory” check out footnote 53 of "Introduction: The Third Restatement of Torts in a Crystal Ball" . To see what else is in the works check out those portions of the paper discussing the assault on the so-called shares defense and the effort to wholly expunge foreseeability from duty and therefore ensure that the ordinarily prudent person test is replaced with an any risk test.

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Way To Go, Joe

I've got to brag on my partner, Joe Lonardo. He just prevailed in a benzene/leukemia case before the Vermont Supreme Court and the opinion is well worth the time required to read and digest it. Building on its decision in Estate of George v. Vermont League of Cities and Towns the court embraced critical thinking and a Bayesian approach to causal reasoning and so held that empty evidence can't change prior, or baseline, beliefs and that  plaintiff's argumentum ad ignorantiam won't fly in Vermont. Here's how it went.

Plaintiff's claim can be distilled to the following:1) plaintiff has lymphoma of the central nervous system (CNS lymphoma); 2) CNS lymphoma is a subtype of non-Hodgkin's lymphoma (NHL); 3) benzene has been shown in some studies to double the risk of NHL; 4) plaintiff was exposed to benzene; 5) an alternate cause of CNS lymphoma was ruled out by his expert; so, 6) plaintiff's CNS lymphoma was caused by his benzene exposure. Q.E.D.

Not so fast, said the Vermont Supreme Court.

The vast majority of cases of CNS lymphoma "are of unknown etiology". Accordingly, our initial belief must be that plaintiff's CNS lymphoma is similarly likely to be of unknown etiology. So what evidence does plaintiff have that might reasonably move a sensible jury away from the belief that any given case of CNS lymphoma is due to some unknown cause and towards benzene? Plaintiff could have shown that he was exposed to a level of benzene that so increased his risk of CNS lymphoma that we ought to consider it as a likely cause. But this plaintiff couldn't show even by a rough approximation what his exposure might have been, much less that the dose experienced appreciably increased his risk of developing the disease. Then again, he could have shown that the manner or circumstances in which he was exposed, whatever the dose, has been found to the likely cause of CNS lymphoma in some similarly exposed group of individuals. But he had no evidence of that either. There was then nothing to cause a sensible person to move off the baseline belief - that plaintiff's was an ordinary disease of life.

Plaintiff next tried the differential diagnosis dance but got nowhere. The court clearly understood that an unweighed risk factor, abstract and disconnected from the circumstances (i.e. dose/exposure) in which it was detected is not the same thing as a potential cause to be weighed in a differential diagnosis or process of elimination exercise. Thus it held that any attempt to establish benzene as the cause of plaintiff's CNS lymphoma by ruling out everything else "must fail" because plaintiff couldn't demonstrate that his benzene exposure belonged among the potential causes to be considered in the first place.

The court then demonstrated that critical thinking isn't just for good scientists. Plaintiff had found an expert who could rule out one cause of CNS lymphoma and so he constructed the following argument: 1) plaintiff has CNS lymphoma; 2) some cases of CNS lymphoma are caused by an immunodeficiency disorder; 3) plaintiff doesn't have an immunodeficiency disorder; therefore, 4) benzene caused plaintiff's CNS lymphoma. That's about the purest form of the fallacy known as the appeal to ignorance and the Vermont Supreme Court would have none of it. (It's also, by the way, a sort of enthymeme, an argument with a hidden or unexcavated premise - here, that any benzene exposure is a potential cause of CNS lymphoma - and it lies at the heart of most "reasoning to the best explanation" seen at the courthouse). The court held that when the cause of most cases of a disease is unknown the ruling out of one cause cannot be evidence in favor of some other cause. 

Finally, and quite interestingly, the court briefly elaborated on its decision in George; an opinion which has come in for criticism from those hoping lower the barriers meant to keep out all but sound science (see e.g. "The 'Reshapement' of the False Negative Asymmetry in Toxic Tort Causation"). The court holds it seems to the same view as organizations like the National Academies of Science and the U.S. Preventive Services Task Force - that experts weighing scientific studies ought to be able to say how they did the weighing and to state "the weight given to each study". There is, after all, not much left of the scientific method without measurements and methods.

That's just my take. Go read it for yourself: Blanchard v. Goodyear

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From Post-Normal Science to Post-Normal Law?

Carl Cranor certainly understands the impact of Milward v. Acuity as you can see from his recent blog post at the Center for Progressive Reform. Over the coming days we'll examine several of Cranor's points but for today let's start with his enthusiastic approval of the appellate court's rejection of "an 'atomistic' study-by-study assessment of the scientific basis of expert testimony." 

In the sort of scientific induction that is the basis for most expert opinion in toxic tort cases, broad conclusions are drawn from specific data.  Thus in Milward, plaintiff's expert extrapolated from four particular sets of data to his conclusion that benzene is generally capable of causing acute promyelocytic leukemia (APL) in humans.  The trial court, however, reviewed each particular bit of data which supposedly supported the inference and found each to be wanting and so excluded the opinion.  But the US Court of Appeals for the First Circuit held that "[t]he district court erred in reasoning that because no one line of evidence supported a reliable inference of causation, an inference of causation based on the totality of the evidence was unreliable."  That court then went even further and adopted a view of how science is done that is advanced by just a small cadre of non-scientist academics. It approved Cranor's conception of scientific induction holding that "[t]he hallmark of the weight of the evidence approach is reasoning to the best explanation for all of the available evidence."  The problem, for those of us stuck in The Enlightenment, is that an argument founded on false premises cannot, save by sheer accident, lead to the truth.

Let's say there are four studies recording the incidence of some disease in a work force and the dose, or exposure, to the chemical in question sustained by the workers being studied.  The data, according to plaintiff's expert, looks like this:

From such data a scientist could reasonably infer that there is a relationship between dose and the incidence of disease and specifically that doubling the exposure doubles the risk of disease. Data like that is generally a powerful indicator of a true causal connection if subsequently confirmed by other studies.  But let's say that we examine the four data points and find that the expert has either misreported or misinterpreted the data and that it really looks like this:

What the appellate court has said in Milward is that somehow, based solely on the subjective weight given each bit of data and his interpretation of "the totality" of the data, an expert is free to testify to a conclusion that not only is unsupported by, but is completely at odds with, the premises from which it was derived.  What's going on here?  

What's up is that the Court has bought into, whether it recognizes it or not, the concept of "post-normal science".  It's an idea advanced by Jerome Ravitz and embraced by Carl Cranor and many in the movement that seeks to incorporate the precautionary principle into our laws.  The idea is explicated most clearly in "Towards a Non-Violent Discourse in Science" in which Ravitz explains that the Enlightenment's view of science which has prevailed to this day - that "in the natural sciences, whose conclusions are true and necessary and have nothing to do with human will" ... we must "give up this idea and this hope of [ours] that there may be men so much more learned, erudite and well-read than the rest of us as to be able to make that which is false become true in defiance of nature" (Galileo Galilei) - is yielding to a new conception of science necessitated by our modern scary world. A world in which "facts are uncertain, values in dispute, stakes high and decisions urgent". A world in which Enlightenment-style science too often serves "the morally dubious worlds of profit, power and privilege".

Essentially the idea is that science has become "authoritarian". It imposes what it claims to be truth on people who have genuinely held beliefs that lead them to a very different conception of how the universe works. And when it comes to risk, it ignores social constructions of risk that lead people like Cranor to believe that, for example, autism is linked to pharmaceuticals, alcohol and living too close to a freeway. Consequently, "housewife epidemiology" and the fervently held beliefs of activists ought to be weighed in the scales of judgment alongside the data and the test results of such theories.  (See "Legally Poisoned: How the Law Puts Us at Risk From Toxicants"). Most importantly it embraces the view that there are indeed people, experts, "so much more learned, erudite and well-read than the rest of us" as to hold a view of truth immune to, and indeed beyond the reach of, "normal science".

It's all, in our view, a dreadful misreading of Thomas Kuhn's "The Structure of Scientific Revolutions". It twists the conclusion that scientists are no happier to admit their errors than regular folks into a claim that all science is a sort of social construct - that there is no truth, and that what scientists really do is to weigh the facts they find relevant to a nicety in the scales of their subjective judgment. And by incorporating such a view into our law, originally, at least, derived from and founded upon the empiricism of the Enlightenment, we adopt a view in which the law exists not to guide our future actions as citizens but rather, typically ex post facto in the case of toxic torts, to support whatever fad or fear motivates us in the moment.

More in coming days.

Bostic: Baron & Budd Swings For The Fences

As we've discussed previously, the Dallas Court of Appeals in Bostic made it logically impossible for a plaintiff injured as the result of multiple potentially causative exposures to recover from any of those responsible for the exposures. They did so by holding that a plaintiff must not only show that the aggregate dose was the "but for" cause of his injury, but also that each defendant's component dose was the "but for" cause of his injury. Thus, if plaintiff were exposed to two doses, each sufficient to have caused his injury, both defendants could argue with equal force under a "but for" standard "had my product never existed plaintiff would still have been injured because of the other guy's product and so my product cannot possibly have been the 'but for' cause of plaintiff's injury".

The source of the problem seems to originate in confusion over what the Texas Supreme Court means by "substantial factor", We've been arguing since our amicus in Borg-Warner that the essence of every court's discussion of foreseeability or proximate cause is risk. Since, as the National Academies put it in Science and Decisions, "[v]irtually every aspect of life involves risk", what courts have been doing is drawing boundaries between those risks for which the imposition of liability would be just and those for which the imposition of liability would be unjust. Substantial factor then means substantial risk and in toxic tort cases risk is measured by exposure, or dose. A plaintiff need only show that "but for" his exposure to asbestos (in the aggregate) he would not have developed mesothelioma but if he's to carry his burden of showing substantial factor causation he must estimate dose for each defendant's contribution to the overall dose. And that's what we thought Borg-Warner said.

Bostic argues in her brief however that any requirement that a plaintiff show what the dose received from an individual defendants product or premises was likely to have been would make it "scientifically impossible" for any plaintiff to prevail. She says that her expert Dr. Longo testified "that it would be scientifically impossible for him to calculate the precise dose of asbestos" that Bostic experienced as a result of his use of Georgia-Pacific's products. Of course Borg-Warner specifically says that a plaintiff is not required to state with mathematical precision the dose-contribution of each defendant. A supportable approximation is good enough. Bostic further implies that coming up with even an approximation of dose is impossible. Is it?

In 1995 Harvey Checkoway wrote: "Quantitative estimation of exposure has become a central focus in occupational epidemiology over the past decade as a result of the increasing emphasis put on exposure-response characterisation for occupational hazards." He concluded by writing: "Methods of assessment of exposure have been given much more attention in recent years. As a result, increasingly sophisticated approaches to retrospective assessment have been developed ... Nevertheless, no amount of foresight and prospective monitoring will replace the need for sound approaches to retrospective estimation of exposure, and the variety of methods now available provide a basis for that work." Not only have such methods been available to expert witnesses for years their use in benzene and other toxic tort litigation is nowadays utterly unexceptional.  

Of course a supportable retrospective dose estimation is possible and it's done all the time. The attempt to substitute Dr. Longo's estimation of the highest dose from a one time use of Georgia-Pacific's product for Bostic's estimated total dose from its product is akin to substituting the amount of tar and other particulate generated by one cigarette for a plaintiff's pack-years of smoking - it evades the real question of "what was the risk?" and answers instead another question "was there any risk?" It's an effort to conflate risk and causation and so, without saying so, to get the Texas Supreme Court to adopt the Restatement (Third) of Torts and its attempt to substitute any risk for a substantial risk as the outer boundary of liability. Should they prevail they'll have knocked the cover off the ball.

 

For Want Of A Nail? It's Worse Than That (If You're A Railroad Company)

The Supreme Court decided CSX v. McBride and here's our take. The majority held that whatever proximate cause might be it isn't a hurdle an FELA plaintiff must clear. Instead, without saying so, the court concluded that such a plaintiff has only the causation obstacle set out by the dissent in Palsgraf to deal with. Specifically, "but for", or counterfactual, causation plus the act of a not ordinarily prudent railroad company (requiring foreseeability of some, though not necessarily the, harm). A railroad company thus owes a duty not to the whole world but to its employees' whole future. Put another way, should a railroad do something "wrong" that produces not the harm the apprehension of which would have counseled a different course but which instead puts the employee in a place he otherwise wouldn't be so that he subsequently suffers a completely unforeseeable injury, the railroad is on the hook for the damages.

We are sad of course that the Court didn't take the opportunity to consider legal causation to be properly understood as "but for" causation plus risk. However, given the fact that the Court was interpreting a statute half a century old (one that Congress, by its steadfast refusal to change the Act's language regarding the causation standard, apparently doesn't consider to be the source of absurd or unjust results) the outcome isn't surprising. And it didn't help that the jury instruction on causation requested by CSX, "any cause which, in natural or probable sequence, produced the injury complained of", would shed no light on the distinction between pure "but for" causation and legal causation anyway. Most if not all proximate cause instructions indeed appear to be little more than, as one of our mock jurors muttered of the instruction, "typical lawyer BS".

Had Ms Palsgraf been an employee of the Long Island RR (and had the FELA's "played any part" causation standard been around) she would have prevailed. Bad news for the railroads but good news for anyone else not stuck with the FELA causation standard since whatever the court thinks proximate cause might be at least it's more than "played any part".

"Hypotheses Are Verified By Testing, Not By Submitting Them To Lay Juries For A Vote"

That quote comes from the conclusion of Judge Cecilia Altonaga's Order granting defendant's motion to exclude plaintiffs' experts in In Re Denture Cream Products Liability Litigation. If you're interested in the problem of causation in toxic tort cases this little gem would make a great primer.

Of particular interest are the following: (a) the court's dissection of the experts' arrangement of bits of unrelated data into what to the casual observer might appear to be a sound deductive argument; (b) the court's discussion of causal inference via induction and its implicit requirement that experts assess ( weigh) and then disclose the strength of their belief in each premise of the argument; and, (c) the court's recognition of the problem of selection bias when paid experts are allowed to opine as to causation using a so-called differential diagnosis or differential etiology approach - they tend, presumably subconsciously, to populate the line-up of suspect causes with the defendant's product and three or four easily ruled-out alternatives.

We especially liked the following about the opinion of plaintiffs' experts: "This theory is not ridiculous, but neither is it necessarily true; it is ripe for testing." That's what we said about Milward. All the plaintiff had was a plausible yet untested (because, said her expert, it was untestable) theory. Traditionally, that hadn't been nearly enough.

There's a clear split between the circuits with most requiring evidence that a theory's prediction has been confirmed at least once before it can go to a jury while a couple of others require only plausibility and an expert willing to say that it's so based on his or her scientific judgment. So it's the empiricists vs. the epistemological anarchists; Popper v. Feyerabend. If the Supremes decide to have a look it'll be a very big deal.

Discretizations

A risk-based tax on rubber duckies?

Tumors are superorganisms.

Kentucky adopts the economic loss rule. (An especially well written opinion btw).

To be injured, you have to be injured. (Wis Ct of Appeals: another well-reasoned opinion worth reading)

Roggli shows that brake repair workers got their meso from commercial amphiboles.

The Texas Supreme Court Issues an Unsettling Opinion on Causation

BIC Pen Corp. v. Carter has been decided, again, and seemingly for the last time. The court previously disposed of the design defect claims and this time the tragic case of a little girl severely burned as a consequence of her five-year-old brother playing with a lighter was before the court on the issues of manufacturing defect and causation.

Given that BIC's own tests of the lighter involved in the accident showed that a flame was produced more readily (because less force was required) than designed the court steamrolled over BIC's manufacturing defect arguments. It gave especially short shrift to the manufacturing variance argument (which actually has a lot of merit). Thus, by the time the opinion gets to causation, a defect for which liability may be imposed having just been found, to the reader things look pretty grim for BIC.

The court focused immediately on the issue that decides causation. Since lighters are designed to be child-resistant and not child-proof (as otherwise lots of adults could not operate them) how do we know that Carter's brother wouldn't have been able to light it anyway? Which is to ask how do we know that but for the defect Carter's brother would not have started the fire? Clearly Carter has to produce some evidence that her brother was enabled by the defect since even if a lighter meets the CPSC standard for lighters it may still be usable by 15% of children his age.

First the court looks at evidence that the brother was developing more slowly than a typical boy his age. The idea is that if the boy was cognitively more like a four-year-old than like a five-year-old then it's more likely that he was indeed enabled by the defect. The court quite rightly decided that it was an apples to oranges assertion because the defect was in a feature meant to physically deter children whereas there was no defect found in the mechanism meant to confound them. Next the court turned to Carter's contention that she could prove her brother was enabled by the defect using the reasoning of Havner.

Carter points to data indicating that low-force-to-operate levels in lighters such as the one in question quadruple the likelihood of a child being able to produce a flame. If Havner requires a doubling of the risk isn't a quadrupling more than enough? Before we get to how the court decided this issue let's run the numbers. As best we can tell there is at least one good test showing that the number of children able to active the lighter goes from 4% to 16% when the physical deterrent to ignition (force) is reduced. Now, assuming that the lighter in question produced a reduction in force necessary to produce a flame similar to the one used in the test then we can calculate how likely it was that Carter's brother was enabled by the defect. Using Bayes' Rule, the likelihoods of ignition for as-designed lighters and reduced force lighters and our knowledge that the lighter in question was in fact defective we can calculated that the likelihood that Carter's brother would not have been able to start the fire (i.e. was enabled by the defect) but for the defect is 75% - a result easily clearing the "more likely than not" hurdle.

Now, the court could have decided that the quadrupling of risk of ignition involved a different level of force (which, in fact, it did) and that plaintiff had zip, zero, nada evidence that the reduction in force at issue (a very tiny one) has ever been shown to double, much less quadruple, risk (which, apparently, it has not). That would have preserved and extended to manufacturing defect cases the rational decision-making approach to uncertain cases established by the court in Havner. Instead, the court decided that probabilistic reasoning can't be used in manufacturing defect cases and gave an extraordinarily weak rationale for doing so.

The court held that "[t]he nature of the injury-causing activities and testing that would have to be done to show causation in this case are not similar to, nor do they pose the practical difficulties posed by, those we considered in Havner. In this case, testing of J-26 lighters posed no unreasonable risk of injury to the test subjects as would have been the case if testing of the drug on humans had been performed under the facts of Havner ... In such instances, tests are done with surrogate lighters that do not pose a risk of harm to the participating children. And testing was also performed on the Subject Lighter itself that posed no risk of injury. Thus we decline to adopt a Havner-type analysis as to causation in this case where manufacturing defects are the basis for the liability claim."

So, because the test subjects tested lighters that didn't contain butane and because the lighter in question posed no risk of burning children when it was tested in a lab post accident, modern techniques for inferring causation aren't appropriate? With all due deference that makes no sense whatsoever.

Maybe the court was worried about permitting Havner-esque analysis in manufacturing defect cases because eventually it would be deployed in a case where the allegedly defective product had been lost or destroyed. If so, a defendant's product could indeed be found to have been more likely than not the cause of the accident even though the product was lost or destroyed. But for that to happen one of two things would have to hold true. Either the defect was responsible for a huge percentage of all such accidents or a huge percentage of the product had been manufactured defectively. In this case, for example, had the lighter been destroyed in the fire plaintiff could not show "more likely than not" (even assuming a quadrupling of the risk) unless she could also show that at least two-thirds of all lighters had the reduced-force defect. Either way, imposing liability when a defect is almost always the cause of an accident or when almost all of the product involved has been defectively manufactured hardly seems an injustice.

Case by case for more than a decade the Texas Supreme Court has worked to produce a coherent and just approach to causation by demanding sound science and utilizing modern decision theory approaches when reasoning out the cases before it. Hopefully, given our fondness for Havner, the true meaning of BIC Pen Corp. v. Carter is exceptio probat regulam in casibus non exceptis.

The Attempted "Reshapement" of Toxic Torts

Building up to the publication of the Restatement (Third) of Torts and now reaching what must surely be a crescendo has come one law review article after another assailing various courts' (re)adoption of the Enlightenment's view of causation and their (re)embrace of empiricism. Last Friday for example we posted a link to a recent paper making the case that loose causation standards (as opposed to those of "classical liberalism") in toxic tort cases are vital to the consolidation and empowerment of "the administrative state". And a couple of days before that we wrote about another new article that attempts to provide intellectual support for the proposition that the consequence of courts' application of strict causation standards has been to tip the scales in favor of defendants. Today we'll address an assertion from the second article.

On page 107 author Gold makes the following claim: "To the extent courts treat general and specific causation as separate elements requiring distinct proof, plaintiffs who already confront scientific uncertainty may be required to jump two hurdles instead of one - increasing the likelihood of false negative adjudications on causation." What he's done is to confuse what happens when we estimate the probability of the conjunction of two events (here: e.g. the likelihood that tetra-methyl death (TMD) can cause prostate cancer and the likelihood that plaintiff's prostate cancer was actually caused by TMD) with the manner in which false positives and negatives are identified and the manner in which the odds of being false negative or false positive are estimated. A simple illustration will hopefully suffice.

On chromosome 19, carried by both men and women, is a gene, KLK3, a variant of which is highly correlated with prostate cancer. There's a test for prostate cancer that looks for the KLK3 variant. Since both men and women carry the gene what happens to the number of false negatives (the KLK3 test shows they don't have the variant but later they're found to have prostate cancer after all) and false positives (the test says they have it but they really don't) if a general causation "hurdle" like "can women even get prostate cancer?" is placed before the KLK3 test? The number of false negatives is unchanged (good) and the number of false positives is cut in half (great).

What we suspect Gold is trying to complain about is the following: If we're 51% sure that TMD is a cause of toe cancer and 51% sure that of the possible causes of plaintiff's toe cancer TMD was actually the cause of it then across the set of toe cancer plaintiffs there will be some who recover nothing because of the extreme uncertainty in the science. But that's really just proof that the law is far too lenient towards plaintiffs in toxic tort cases.

What are the odds that our hypothetical toe cancer plaintiff actually got his toe cancer from TMD? Only 26.01% (51% x 51%) - hardly "more likely than not". Yet every court in the country will let a toxic tort plaintiff stack uncertainty upon uncertainty, "more likely than not" upon "more likely than not" to get to a cumulative "more likely than not" in spite of the fact that mathematically that ain't how it works. Furthermore, given the fact that courts will allow plaintiffs to establish both general and specific causation with a single study demonstrating a relative risk (RR) of 2.0 and given the fact that most published research findings with low (less than 4-ish) RRs are false anyway the odds that our toe cancer plaintiff waving his toe cancer - TMD peer reviewed paper actually got his cancer from TMD is no more than 13% (51% x 51% x 51%) and likely much lower - yet he'll get to a jury, meaning he'll be offered a settlement, in every courthouse in the land.

At the end of the day the "Reshapement" of toxic torts won't increase the odds of truly wronged plaintiffs being compensated but it will, where adopted, swamp unfavored companies with meritless claims - perhaps that's the whole point of it.

 

 

Discretizations

The "Reshapement" (Third) of Toxic Torts?

Want some more evidence that at least with regard to toxic tort cases the Restatement (Third) of Torts is nothing of the sort but rather an effort by "the academy" to impose its vision of what the law ought to be? Read "The 'Reshapement' of the False Negative Asymmetry in Toxic Tort Causation".

The central premise of the paper is that for a variety of reasons the law has decided to err on the side of letting victims of toxic chemicals go uncompensated (a sort of "false negative") rather than letting errors of judgment fall with equal frequency on the wrongly accused (the false positives). However, unlike say the science surrounding breast cancer and mammography the author presents no data to demonstrate that there are more victims on the Plaintiff side of the ledger than on the Defendant side. Instead, he argues in essence that because science (as opposed, somehow, to plaintiffs' retained scientist experts) plays it safe and errs on the side of false negatives. By adopting such methods the courts then necessarily put a thumb on the "D" scale.

Of course the real reason epidemiologists, toxicologists and the like have learned to go slow in the face of uncertainty is that the proportion of false positives to false negatives was enormous throughout the 70s, 80s and 90s. Small relative risks and the peculiar metabolism of mice launched false health scare after false health scare. Contrary to what the author suggests the vast majority of positive findings have turned out to have been false - that's why coffee alone has been falsely implicated in more cancers over the last forty years than has human carcinogenicity been confirmed in all chemicals combined.

There's lots to dissect in the paper and we'll be doing so in coming days. One topic we'll hit is the effort to sneak the so-called precautionary principle into the law via Comment "c" of Section 28, Liability for Physical and Emotional Harm. See page 1572 for the author's approving nod to the effort which had previously been denied by the comment's reporters.

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The Differential-Diagnosis "Methodology"

The case of Pluck v. BP Oil Pipeline Company, decided last week by the U.S. Sixth Circuit, turned on whether the opinions of plaintiffs' expert were properly excluded as unreliable and on whether his attempt to salvage them, by subsequently filing a supplemental report stating that upon using the court-approved "differential-diagnosis methodology" the identical evidence-free opinions had (not surprisingly) been reached, was timely. The court answered "yes" and "no", respectively.

Along the way to reaching its decision the court restated its view of the soundness of the differential-diagnosis methodology in deciding the cause of a individual's illness. Lots of courts have been saying the same thing of late. But all they're really saying is that using a decision tree to make a decision is OK.  That's like saying that using a digital calculator to calculate the length of the hypotenuse of a right triangle is OK. It doesn't, however, say anything about about whether the data used was accurate nor even about whether the determinative quantities had been measured in the first place.

When we think about differential diagnosis we ought to be thinking of something like this excellent example from Baylor College of Medicine's Radiology Club. Working from a variety of well established causes of a liver mass and precisely measured tests for the presence of each the physicians were able to rule in cholangiocarcinoma while methodically ruling out a variety of other potential causes. We'll save for another day the question of whether or not such a methodology was ever intended to, or is any more capable than cast dice or chicken entrails of, identifying heretofore unrecognized causes of a particular illness a la Milward.

Instead, here's what can happen when a court is satisfied with the utterance of the magic phrase "I used the differential-diagnosis method" and decides it's up to the jury to determine whether the expert's rulings-in and rulings-out are sound. We'll change the facts to those of a well-known example to protect the innocent and to keep us out of trouble with a certain court.

Consider the following, modified from "Judgment Under Uncertainty: Heuristics and Biases". The known, possible causes of plaintiff's illness are either "genes" or  "tetramethyl-death". Bad genes account for 85% of all cases while "tetramethyl-death" is only rarely indicted, accounting for just 15% of the cases. Plaintiff's expert says that plaintiff was exposed to "tetramethyl-death" and didn't have the bad genes. The court believes (perhaps because plaintiff's expert has made the mistake of going out on a Bayesian limb and giving an estimate of his faith in his estimation, hint, hint) that 80% of the time plaintiff's expert is able to accurately distinguish between cases caused by "tetramethyl-death" and those caused by bad genes. What then are the odds that plaintiff's illness was indeed caused by the chemical exposure rather than his genes?

Significantly less than 50%.

So the question becomes, essentially, should a verdict finding that one and one sums to three be upheld assuming the parties had a full and fair opportunity to cross examine the purveyor of such nonsense? A surprising number of jurists say "yes". That's what happens when you don't examine the alleged support for each branch of the decision tree; and that's what happens when you don't "get" percentages.

The Every Fiber Theory: Reductio Ad Absurdum

There's been considerable buzz about Betz v. Pneumo Abex; an asbestos case pending before the Pennsylvania Supreme Court.  Recently several noted scientists underscored the importance of the case when they filed an amicus brief asking that the court reverse the Superior Court's ruling - a decision which would result in the plaintiff's expert being permitted to testify that each and every fiber of asbestos to which the plaintiff had been exposed was in fact a cause of his illness.  The brief itself is somewhat odd and doesn't read much like the other works of the scientists involved; some scientific concepts having seemingly been lost in translation.  They do however make one important point.  Unfortunately, they don't address the fundamental issue that bedevil this litigation.

The point they make clearly is that the assertion that every fiber of asbestos is the cause of a subsequent disease is not a scientific one.  Scientific claims require confirmation, which is to say that they're not merely hypotheses but are ideas that are testable, that have been tested and have survived those tests.  In the case of the "every fiber" claim the scientists note that there's no evidence for it and that multiple studies involving exposure to low levels of asbestos have repeatedly refuted the claim.  They make an especially strong plea for courts to remember the role that empiricism plays in the scientific method.

What remains unaddressed is what to do with a case in which the illness was allegedly caused by the aggregation of multiple small doses.  In other words, as the plaintiffs frame the question, what is to be done when a camel is found with a broken back and a pile of straw the cause?  Under what theory could any straw be absolved of blame?

Let's answer that question with some graphics.  First up a typical modern case in which a plaintiff with mesothelioma had a combination of exposures from very high to very low.  For the purposes of this discussion assume that 100 f yr/mL is a cumulative exposure that is recognized by plaintiffs and defendants as one that would have been sufficient to have caused plaintiff's illness.  Here's what one such scenario might look like:

 

Let's further define each exposure according to what we think the law is and ought to be with regard to what is called substantial factor analysis.  Those exposures which in and of themselves are sufficient to have caused the illness are necessarily substantial factors.  Those that pose a significantly increased risk, a question for the court and one that may vary  from jurisdiction to jurisdiction, are also substantial factors.  Those that produce only a remote or de minimis risk are not substantial factors.  The graphic looks like this:

Our slide titled "How It Might Play Out" shows a case in which the court has defined the limits of liability and the jury has thereafter determined which of the substantial factors were foreseeable, which is to say risky in their estimation.

The harder case is the one in which plaintiffs argue that exposures that were substantial as well as those that were de minimis can just as arbitrarily be grouped into a subset of exposures the aggregate dose from which could clearly have been causative.  It looks something like this:

As formerly peripheral defendants who were bit players in the asbestos industry have gone bankrupt we've increasingly seen cases with nothing but defendants whose conduct individually never produced more than a nearly infinitesimal risk of illness.  And given that trend this is what plaintiffs' cases will look like in the future:

Assuming arguendo that multiple small doses of asbestos which have never been shown to have caused any illness whatsoever are in the aggregate capable of producing mesothelioma, how do defendants argue that they ought not be liable?  The answer begins with the fact that an unwritten rule for asbestos litigation has evolved over the years. That rule is "causation equals liability".  That was never the rule.

Now however, as with the circumstance of Ms. Palsgraf in which she could not recover because the risk to her created by a guard trying to help a stumbling passenger was too remote, courts wrestling with asbestos litigation are beginning to come to grips with the fact that many of the defendants left in the litigation are being sued for producing risks that were orders of magnitude smaller than those posed by everyday facets of life such as taking a shower, shaking a stranger's hand or eating an extra slice of pizza. And some courts are starting to apply the same rules that they apply to other cases in which the conduct was ordinary and the outcome remote - that it cannot be the law that any action a person takes, however benign or ordinary, subjects her to being hauled into court should she be that one in a million person whose ordinary conduct produces an extraordinary outcome.

And thus to the camel's claim. Ultimately the question is whether some conduct is so common and so unexceptional as to not, as a matter of law, subject the actor to liability; even though by way of one of life's tragic chances her simple action one day manifests in harm to another. The Restatement (Third) of Torts answers "no, never".  On the other hand, in every context outside of asbestos litigation, American courts have overwhelmingly answered "yes".  "Yes", because they recognize that we all make our way, with rare exceptions, as best we can through a world of inevitable and mostly unknown risks. They hold that the extra straw added to the camel's load then, in every case, asbestos or otherwise, ought not subject she who added it to massive and equally unpredictable liability.

Deconstructing Milward (part III)

When we first wrote about Milward we said it got causation wrong. The second time we wrote about it we took issue with the opinion for calling paid-for induction the scientific method. Now we address why we deem the opinion radical.

Should an educated guess, a hunch, especially one that's unverified and worse yet unverifiable, be admissible under Rule 702 of the Federal Rules of Evidence? Not if you're a fan of the Enlightenment and of the empiricism running from the likes of Bacon, Locke, Berekely and Hume to the Framers of our Consitution and all the way to Daubert. The idea that someone could be deprived of life, liberty or property on the basis of a mere guess, however impressive the credentials of the guesser, would we think shock the conscience of most Americans. But embracing without saying so the opposite of empiricism, something between Romanticism and and postmodernism, the First Circuit has said it's A-OK. That's pretty radical.

Defenders of the opinion might object to our claim that the opinion of Milward's expert was nothing but an unsupported and unsupportable conjecture. Didn't he offer five pieces of evidence after all? It depends on what you call evidence.

We all know what evidence for a theory looks like in the hard sciences. Albert Einstein makes a prediction about gravity and thereafter other scientists carry out experiments to see if the prediction pans out. Sometimes the answer comes in quickly and sometimes it takes a little longer but ultimately the conjecture stands or falls not on the reputation of the man but on the ability of his theory to withstand all attempts to refute it. Those attempts at refutation that instead confirm a theory's predictions are one form of evidence. In the somewhat softer science of biology including the study of human diseases such evidence tends to be harder to come by largely because biological systems are made up of so many different parts; the existence and complete function of many of which are still largely unknown.

That doesn't, however, mean that theories about biological function can't be tested. Lab animals as proxies for humans can be exposed to suspected carcinogens; their genes can even be manipulated to see if effects observed are the result of some interaction between agent and genome. Randomized controlled trials are the gold standard of drug testing evidence and though you can't experiment on humans by exposing them to known toxins you can certainly compare the outcomes of those exposed in the past to those not exposed to see if there's an association and if so how strong it is. So what sort of evidence did Milward's expert have to offer?

He offered five "bodies of evidence". First, he said that benzene is a known cause of AML. Ok, but plaintiff had APL. Just as the old expert witness canard "cancer is cancer" retreated to "blood cancer is blood cancer", the claim that all forms of AML are different but really the same when it comes to causation is, as the National Academy of Sciences has said, an assertion for which there is no evidence and one which seems odd given the fact that the various forms of AML have unique presentations, treatments and outcomes.

Second, he said that a particular mutation "is often in part" due to a chromosomal translocation in a precursor cell that can lead to all types of AML, that CML (which is almost certainly not caused by benzene) "often in part" has the same mutation and that APL and other AML subtypes with the mutation share "common genetic susceptibility factors", risk factors and incidence (after age 20). Therefore, they all share a common etiology. Hmmm. Well, ask Bruce Ames if all mutagens are carcinogens. And is there any evidence of causation beyond an association that a translocation "often in part" coincides that the mutation? No. Finally, sharing some risk factors some of the time during a certain period of life doesn't get you anywhere because risk factors after all are themselves nothing but reported associations. What we're left with then is as follows: APL shares some common characteristics with other subsets of AML and sometimes they have a common mutation which mutation is "often in part" caused by a translocation which may be caused by benzene. Thus, while "all AMLs have a common etiology" is an hypothesis that can be formed from such bits it's one for which no confirmatory evidence currently exists.

Third, benzene can cause damage to the chromosomes of stem cells in the bone marrow and that "leukemia cases associated with benzene exposure are more likely to contain clonal chromosome aberrations than leukemias arising in the general population." Presumably, though the opinion doesn't say so, benzene is at least sometimes associated with the translocation that "often in part" causes the mutation that supposedly causes APL. Good. At last something testable. If benzene is a potent APL-agen then people exposed to benzene ought to be at a much greater risk of APL.

Fourth, two benzene metabolites are topo II inhibitors and some topo II inhibitors cause so-called secondary APL cases. Fine. Benzene can be broken down into some things that act like other things that can cause APL. Good for hypothesis generation but where's the evidence that the two benzene metabolites survive to reach and act upon stem cells like chemotherapeutic drugs? Indeed Milward's expert admits that he has merely suggested a plausible mechanism.

Finally, there's a small increase in risk of APL (e.g. RR of 1.4) in one epidemiological study and a few others which which do not refute the notion that benzene may have something to do with APL because there isn't a complete absence of APL among those exposed to benzene. Well, here we are at the lick-log and there's nothing here but a proclamation that at least his hypothesis hasn't been refuted. Worst of all, Milward's expert claims that his theory isn't even testable, saying that the rarity of APL "makes it nearly impossible to perform a large enough study" to answer the question of whether or not benzene causes APL.

So that's it. The only test, an epidemiological study of people exposed to benzene, that could possibly refute his theory that benzene causes APL has produced results that are at best equivocal. Oh, and by the way, a test that would actually answer the question is impossible to do. The trial court concluded that without evidence from a test of his theory that verified its prediction (exposure to benzene causes more cases of APL than would otherwise occur) the expert had nothing more than a hypothesis. The First Circuit took a different view.

When we think of the scientific method we think about something very much like this chart. From the green box on down it's all about empiricism, testing, about "bending over backwards to show how you are maybe wrong" and about always publishing the results of any test of one's theory "whichever way it comes out." The First Circuit has however adopted a very different sort of view of the scientific method - one that stops at the yellow box, one that dispenses with the need for proof. One that trades verification for belief.

It's one thing to hold the philosophical view that there is something oppressive about the scientific method. It does, after all, have the well deserved reputation of going about willy-nilly stomping on all manner of cherished beliefs (e.g. the sun revolves around the earth, stress causes peptic ulcers - sorry A.B. Hill, vaccines produce autism, etc.). It's something else entirely though to let an unverified and unverifiable belief, pseudoscience in fact, be the basis upon which a citizen may lawfully be relieved of his hard-earned cash. Yet the view that objective truth does not exist, that fervent belief by a well-credentialed expert originating from nothing more than his subjective weighing of whatever he thinks relevant is enough and that testability, the demarcation between science and pseudoscience, is not a minimum requirement for the belief to be admissible has now made it from comment c, section 28 of the Restatement (Third) of Torts: Liability for Physical Harm to the First Circuit. Now that's radical.

 

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Tort Reform Bills Pending in the Texas Legislature

ASBESTOS AND SILICA LITIGATION.
HB 2034 by Rep. Doug Miller, R-New Braunfels and SB 1202 by Sen. Dan Patrick, R-Houston.

These bills would allow the judge assigned to the asbestos or silica MDL docket to dismiss without prejudice the tens of thousands of cases that have been pending for years without any action because the claimants have not shown medical impairment. It also would prevent "double dipping" by plaintiffs who apply to asbestos bankruptcy trusts only after trial against solvent defendants as a way of avoiding "settlement offsets."

TRESPASSER LIABILITY.
SB 1160 by Sen. Kel Seliger, R-Amarillo and HB 1971 by Rep. Jim Jackson, R-Carrollton.

Texas common law provides that a property owner owes no duty of care to a trespasser, except in very narrow and well-defined circumstances. These bills would codify these traditional common law rules to preempt courts from adopting liberal provisions of the new Restatement Third of Torts, which would dramatically expand trespasses’ rights to sue landowners and impose costly burdens on property owners.

ELIMINATING THE RESPONSIBLE THIRD PARTY PRACTICE.
HB 1427 by Rep. Tryon Lewis, R-Odessa

This bill would repeal Section 33.004(e) of the Civil Practice and Remedies Code as it is used to provide a means to circumvent limitations periods.
 

Proximate Cause Redefined?

I got an email today from the Texas Bar about an upcoming CLE titled "Proximate Cause Redefined: The Controversy Over Substantial Factor". The TPJC's new definition reads: "'Proximate cause' means a cause that was a substantial factor in bringing about an event, and without which cause such event would not have occurred. In order to be a proximate cause, the act or omission complained of must be such that a person using the degree of care required of him would have foreseen that the event, or some similar event, might reasonably result therefrom. There may be more than one proximate cause of an event."

Two things. First, right after it came out we predicted that the Texas Supreme Court's opinion in Transcontinental Insurance Company v. Crump would cause confusion and controversy. See "Substantial Confusion". We worried that by deploying a substantial factor analysis in a worker's comp setting (i.e. no fault / producing cause framework) it meant that the court had somehow gotten the idea that all "but for" causes could be subdivided into really really necessary causes and merely really necessary causes. And that, I think, is what the first sentence of the new definition tries to capture. Too bad no inquiry as to the necessary-ness of a necessary cause can be sensibly maintained. 

Maybe the court will use Bostic to put the train back on the rails and continue on with its longstanding and sensible approach to substantial factor. Specifically, that an assessment of whether or not a given "but for" cause was a substantial factor is an inquiry for the court and that the question of whether a substantial factor was of a sort  that would have caused an ordinarily prudent person to perceive the risk created is a question for the jury. 

Second, I'd be willing to bet that not one of the next 100 juries to consider this new TPJC definition of proximate cause will have any idea as to what concept it's trying to convey.

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Risk, Duty and Foreseeability

The Restatement (Third) of Torts shrivels duty into an if-then statement executable by even obsolete jurists: if an actor's conduct creates a risk of physical harm then he owes a duty to exercise reasonable care.

Duty supposedly needed a new and simple algorithm because opinions turning on the question of duty were seen as incoherent and generally the result of a court having invaded the province of the fact finder (jury, hereafter). Foreseeability, the reporters decided, isn't the sort of legal or policy question judges decide - it's fact and case specific and thus something lay people relying upon common sense and communal norms of behavior ought to decide.

So that judges need not be completely replaced by computers the Restatement's reporters added that in exceptional cases a court may find that due to some other explicitly stated policy a defendant may not owe a duty. Furthermore, a court may on rare occasions properly find that reasonable people could not conclude that an outcome was foreseeable and so hold that the duty auto-generated by the new formulation had not been breached. Very simple indeed. But how's it working out?

If Nebraska (an early adopter of the Restatement's new duty formulation) is any indication the answer is "same results; different justification". Does a landlord who allows a renter to keep a pit bull owe a duty to a third party bitten by the dog? Sure; but it wasn't foreseeable so defendant wins. See Monica S. v. Nguyen. Does the owner of a road grader that can only be turned off while it's still in gear owe a duty to a mechanic called to fix it who twice accidentally bumps the ignition button causing it to start up and run over him? Sure; but it wasn't foreseeable so defendant wins. See Riggs v. Nickel.

What's going on? Look at the gold disk in my graphic. It contains all the acts, however remote, that created the risk of an injury that came to pass (e.g. the risk the road grader owner's great grandmother created by having his grandfather). American courts have pretty much uniformly taken the position that whatever risk the jury is to focus on should not be too remote. Whether because they recognized that "security is mostly a superstition" or that "a man sits as many risks as he runs" courts have in the past made essentially policy decisions to the effect that only a subset of all risks, those that aren't insubstantial, may be subjected to a foreseeability analysis. It's only for that subset of substantial risks that an actor assumes a duty and only for those risks that a jury may find to have been foreseeable that he can be made liable. Now in Nebraska (and Iowa) courts are finding a duty for every risk but then holding that whatever risks they would have formerly found to have been insubstantial are instead simply unforeseeable.

Rather than deciding the limits of tort liability those courts that have adopted the Third Restatement's concept of duty are instead engaged in the business of deciding the limits of human foresight. Hardly sensible and no improvement over the old rule: "you're under no duty to do the impossible i.e. guard against every 1-in-a-million risk you create". Oh well, at least it's frustrating what I suspect was the real purpose of the new duty formulation - to backdoor the Precautionary Principle into the law of torts.

Deconstructing Milward (part II)

Plaintiff's expert reached his opinion that benzene is capable of causing acute promyelocytic leukemia (APL) in humans by employing a "weight of the evidence methodology. The U.S. Court of Appeals for the First Circuit decided that's ok. Consequently, since no researcher had previously reported an increased incidence of the illness following exposure, since the conjecture that benzene causes APL has never been tested, and since "even delusions are permitted as hypotheses" (see p. 19) in science it's fair to say that the First Circuit has adopted an "anything goes" approach to science in the courtroom (at least so long as your expert is bright enough or at least prepared enough to intone a few magic words). For today let's start with this "weight of the evidence methodology" business.

The court was impressed that plaintiff's expert reached his opinion using a process of elimination approach polished into the more formal-sounding "inference to the best explanation". Essentially the expert picked the evidence he thought was important, weighed it in the scales of his "professional judgment" and found that the theory advanced by his employer was the correct one. The court should have been shocked! Shocked! Instead it was satisfied that an expert weigher paid (as they all are in our advocacy-centric system) to have a thumb on the scale had fairly come to an admissible opinion thanks to his sound methodology. But is basic decision theory the sort of "method" the Supremes had in mind when they decided Daubert?

When you think of methodology, whether in the context of Bendectin or skid marks, you think about whether the expert used sound epidemiological principles or had a sound grasp of coefficients of friction and the relationship between force, mass and acceleration. If she got the methods right and from there opined as to why a justifiable conclusion is the correct one using a "weight of the evidence" approach then sure, let the jury decide. But if the expert chooses what to weigh you know that selection bias is at work; and when the data he decides to weigh is unsupported you know another sort of bias is at work; and when the only defensible items left in his scale are temporality and plausibility then you know that all he has is an untested hypothesis. What the court fails to understand is that the weighing of the evidence doesn't even begin until there is a "validly observed association". Otherwise, all plaintiff's expert has done is to propose a theory that ought to be tested.

When all you have is an untested hypothesis doesn't defendant win? Doesn't plaintiff yet carry the burden of proof? Not in the First Circuit, if Milward stands.

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Deconstructing Milward (part I)

I could write a long and tedious post about Milward v. Acuity Specialty Products Group, Inc. and that's why I'm having such a hard time writing a short and hopefully interesting blog post about it. The problem is that the opinion contains no formal arguments, eschews empiricism and denies the existence of objective facts. In other words, precisely because of the epistemological relativism it implicitly adopts, the attempt to blog about it has become a bit like trying to play croquet with a flamingo. But here goes - piecemeal fashion.

The trial court bifurcated the case into two phases. In the first phase the query was whether or not so-called "general causation" testimony by plaintiff's experts was admissible under Daubert. If such testimony proved to be admissible a trial on the rest of the case, including so-called "specific causation", would follow. Let's think about "general causation" and "specific causation".

The First Circuit's opinion refers us to comment c(3),section 28, of the Restatement (Third) of Torts: Liability for Physical and Emotional Harm for the meaning of the supposed two types of causation in a toxic tort case; the former being "when a substance is capable of causing a disease" and the latter being when "when exposure to an agent caused a particular plaintiff's disease". Everyone seems to think this is obvious but is it and, if it is, what should follow from it?

I readily admit that by 1995 I had added the general/specific causation idea to a CLE presentation I'd started to give on causal inference, A.B. Hill's "criteria" and the inherent difficulty in proving that a particular plaintiff's illness, sans aplastic anemia, asbestosis, etc, was caused by some agent established by frequentist methods to be a carcinogen. Now I'm not so sure. Here's why.

We all agree that fired bullets generally cause holes in those they strike and in the toxin context that carbon monoxide (or cyanide, etc) generally causes chemical asphyxiation. But why do we so readily agree? Because everyone struck by a bullet or exposed to carbon monoxide will experience some degree of indentation or asphyxiation. Yet the vast majority of workers exposed to benzene or asbestos never develop any symptoms nor even any signs of prior exposure. Take the unibestos workers at Pittsburgh-Corning's Tyler, TX facility. It's true that 9% have developed mesothelioma but why haven't the other 91%, after almost 50 years, developed mesothelioma? You can ask the same question about benzene or radium dial workers and you'll get the same answer. You'll also find that the dose response curves flatten out. What does it mean?

It means that amosite asbestos causes mesothelioma in people susceptible to getting mesothelioma from amosite asbestos and that benzene causes AML in people susceptible to getting AML from benzene. In essence it means that there is no "general causation" and that all causation is specific to the individual. That's actually a good thing for plaintiffs because causation can then be established by means other than by epidemiology - by detecting biomarkers, asbestos bodies and the like.

But it also means that Milward has to prove that somebody, somewhere got the form of leukemia from which he suffered, APL, following benzene exposure. Milward's expert could find no such case. The best he could do was to say that in some studies of benzene-exposed workers some cases of APL (a rare yet widely found and naturally occurring blood cancer) had been found. He basically admitted that such evidence would fail the inferential tests of strength and consistency and said instead that the fact that cases of APL were found bolstered his opinion by demonstrating that it was not manifestly false.

Thus my first beef (I'll go page by page in the days to follow): asserting that a claim (here, that benzene causes APL) is probably true, or is more likely true, because it has not been proven false is in fact the logical fallacy known as argument from ignorance. Not pretty. Not pretty at all.

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Georgia-Pacific's Response in Bostic

 

It really will be The End of Toxic Tort Litigation in Texas (at least for any case involving multiple sources of exposure) if the Texas Supreme Court adopts the position on substantial factor causation urged by Georgia-Pacific in its recently filed Response in Georgia-Pacific Corporation v. Bostic. Let's hope the court begins and ends its analysis with exposure/risk as Bostic never proved more than a de minimis exposure to Georgia-Pacific's product.

Georgia-Pacific first says about substantial factor causation that the court's Flores opinion requires plaintiff to establish that "but for" his exposure to Georgia-Pacific's product he would not have developed mesothelioma if he's to carry his burden of proving substantial factor causation. To support this argument Georgia-Pacific says that the court adopted section 431 cmt. a (1965) of the Restatement (Second) of Torts when it decided the substantial factor causation issue in Flores. Georgia-Pacific quotes the comment emphasizing "it is not enough that the harm would not have occurred had the actor not been negligent ... [T]his is necessary, but it is not of itself sufficient. The negligence must also be a substantial factor in bringing about the plaintiff's harm." Georgia-Pacific argues then that "under Flores, to prove substantial factor causation, a plaintiff must prove that the harm would not have occurred "but for" the defendant's conduct."

I think Georgia-Pacific has it wrong. "Substantial factor" causes are a subset of "but for" causes and not the other way around - a vital distinction when we get to what constitutes a "but for" cause in a toxic tort case.

Under the Restatement's formulation (and that of every other court that has put some thought into it) causes that are substantial factors are clearly a subset of all "but for" causes. In essence, some "but for" causes are not "substantial factors" as they are, for whatever reason, beyond the limits of liability. Think for example of Ms Palsgraf's case. If we make a set of all non-trivial "but for" causes of her injury we find within it (a) a running, stumbling passenger; (b) defective fireworks; (c) overly vigorous guards who jostle the passenger; and, (d) an unsecured scale. Remove any one of (a) - (d) and the accident would not have occurred. Each is thus a "but for" cause. However, we know that (c) at least is not a "substantial factor" or "legal cause" or "proximate cause" (depending on your jurisdiction) and thus not all "but for" causes are substantial causes.

Asbestos presents a very different problem. What, according to the parties in Bostic, are the non-trivial members of the set of "but for" causes of Mr. Bostic's mesothelioma? There's only one - (a) asbestos exposure. Asbestos exposure is the "but for" cause.

Now, since the identity of the fiber or group of fibers actually responsible for a plaintiff's disease is unknowable, the questions to be answered are: (a) do you impose liability for every fiber; and, (b) if not, how do distinguish between those for which a jury can reasonably impose liability and those for which they cannot? Flores answered those questions (a) "no"; and, (b) not by requiring that a plaintiff do the impossible - i.e. prove which subset of his asbestos exposure was responsible and that without it he would not have become ill - but rather by requiring that a plaintiff merely prove that the exposure complained of was more than de minimis and to do so not by his expert's ipse dixit but rather by some estimation of the range within which the particular dose fell along with evidence that exposure to such a dose posed more than a de minimis risk. A substantial factor in the toxic tort context in Texas is thus an exposure that was more than de minimis and so one that posed more than a de minimis risk.

Georgia-Pacific then goes even further. It argues that "a plaintiff must show that his exposure to a defendant's asbestos-containing product was sufficient to cause his injury ..." A sufficient cause is a complete cause. In other words, Georgia-Pacific is taking the position that plaintiff must show not only that the dose was more than de minimis but also that the dose for which it was allegedly responsible was sufficient, without any other exposures, to have caused the illness complained of. Think of it this way, if it took 100 fibers to cause mesothelioma and three defendants each exposed a plaintiff to 99 fibers for a total of 297 fibers no defendant could be held accountable because none supplied at least 100 fibers. Combine that with Georgia-Pacific's argument that all sufficient causes must also be "but for" causes and a plaintiff who could prove a defendant's product was more likely than not the cause of his illness would never win so long as there was another sufficient cause of exposure within his set of all asbestos exposures. To so hold the Texas Supreme Court would have to overturn decades of precedent as it has for half a century held that such a rule would make it "impossible for a plaintiff, though gravely injured, to secure relief in the nature of damages through a joint and several judgment by joining in one suit as defendants all wrongdoers whose independent tortious acts have joined in producing an injury to the plaintiff, which, although theoretically divisible, as a practical matter and realistically considered is in fact but a single indivisible injury." Demanding an obviously wronged plaintiff do something that logically cannot be done in order to recover from those undoubtedly at fault doesn't seem very fair and so I'm pretty sure the current Texas Supreme Court won't be overturning Landers.

In the end Georgia-Pacific should prevail because Bostic never proved more than a de minimis risk from Georgia-Pacific's products. That's enough. I just hope the court doesn't buy into those other arguments discussed above because if adopted they'd place insurmountable hurdles between many wrongly and preventably injured plaintiffs and the courtroom.

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Milward v. Acuity Specialty Products: Popper Out; Feyerabend In

My write up of Milward v. Acuity Specialty Products Group, Inc. is seven pages long yet far from finished.  Since it's very late I'll post just this for now. Whether the court intended it or not Milward, a benzene/APL case, is a radical opinion and a dramatic departure from Daubert v. Merrell Dow.

Milward adopts the "free for all" view of the scientific method favored by technophobes, chemophobes and especially plaintiff lawyers. Meanwhile, it drops the requirements of testability and falsifiability, turns Sir A.B. Hill from a fan of Hume and Popper into a verificationist with a list of things that don't actually matter, and concludes by holding that if an expert's opinion rests on four propositions, all of which are faulty, his opinion is nevertheless admissible so long as he says that "the totality of the evidence" informed his subjective judgment.

To help it understand the scientific method and how tort law should incorporate the concept the Milward court turned to the author of "Legally Poisoned: How the Law Puts Us at Risk from Toxicants" as well as a number of articles going at least back to 1982 that advocate against cost/benefit analysis and in favor of what is now known as the Precautionary Principle and the use of the tort system, once Daubert is out of the way, to effect its purpose. Throw in the court's understanding of comment c from section 28 of the Restatement (Third) of Torts: Liability for Physical and Emotional Harm, then read "The Tyranny of Science" when it's released later this month and you'll understand what Milward is all about and why it's such a big deal.

In coming days I'll go through Milward item by item starting with the elevation of (paraphrasing) 'process of elimination through subjective judgment founded on concepts of society, collective duty and environmental justice' to a scientific method.

Fixing a bankrupt system, one law at a time

The Texas Legislature is set to consider a bill to close a gaping loophole in asbestos litigation: forcing Plaintiffs to apply to asbestos bankruptcy settlement trusts BEFORE initiating litigation. There are dozens of bankruptcy trusts set up to pay people who have an asbestos-related disease. Many of these involve the largest asbestos companies in the country, such as Johns Manville, Celotex, H.K. Porter, etc. They are funded with billions of dollars.

Texas also has a statute to allow defendants to prove liability by third parties, including bankrupt companies. The plaintiffs have to submit applications to the bankruptcy trusts which allege exposure to the products of the bankrupt companies. The trust applications and dollar amounts paid are then admissible in the lawsuit. This works to make sure there isn’t a double recovery for one injury.

All that goes wrong, however, when the plaintiff waits until after their lawsuit is concluded before applying to the bankruptcy trusts. This becomes a big issue in Texas where we have a fast-track docket that allows dying individuals to have an expedited trial setting. There is a very real potential for a plaintiff to swear they have no idea who manufactured the insulation or gaskets or joint compound they were exposed to, or to not remember the brands of bankrupt entities. Then, after the lawsuit is over to suddenly remember and file the trust applications.

This loophole is finally being addressed.

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Courts Are Starting To Get Hindsight Bias

One day, out of the blue, a common and widely used chemical which had been tested many times on many different species of lab animals without effect caused a particular strain of mice to develop cancer. Government and industry got together, funded epidemiological and toxicological studies and then agreed on a new and dramatically lower occupational exposure limit. The system worked, right?

Soon those who produced the chemical, even those who produced its utterly innocuous precursors, those who made things with it and those who transported, bought, sold, released or disposed of it were all defending claims by plaintiffs who had been exposed to it decades before. But how could these claimants prove their cases when government and industry had tested the product repeatedly and had found no rat, mouse, dog or monkey that suffered any ill effect short of exposure levels in the range that would produce asphyxiation?

Easy! Find an article detailing the product's important metabolites, find an article suggesting that one of the metabolites is mutagenic, find an article showing that the metabolite was known to result from metabolism of the product, find an article showing that the particular strain of mouse in question was thought by someone, somewhere at some time to be a good model for human carcinogenesis and find an article suggesting an exposure protocol which wouldn't be used until years into the future but which would result in the metabolite otherwise not produced by traditional exposure methods. Having found such easily identified articles plaintiffs' counsel was able to claim that any good company truly interested in worker health would have discovered the product's carcinogenicity no later than 1964.

We went and deposed the authors of those old papers strung together to show that what was unknown was in fact knowable and they unanimously said "Ummm, no". No one cared about the product's metabolites because it wasn't considered to be a carcinogen and the metabolite in question was tested way back when because it was a metabolite of something else and that something else turned out not to be a carcinogen and oh by the way skin-painting and ingestion studies not what came two decades later were state of the art in the early 1960s. Whew.

Then we tried plaintiff's "duty to test / duty to discover" theory to three mock juries. Every one found for the plaintiffs and every one found that what would not be suspected, much less discovered, for another two decades was in fact knowable by the early 1960s. Indeed, the future was so obvious that one mock jury found "wanton indifference" and another decided exposing workers after 1960 amounted to an intentional tort.

Those thirty-six pretend jurors with an average education at about the tenth grade level were hardly oracles. Their extraordinary powers of foresight were, oddly, limited to the product in question. In breakout focus groups after the mock jury research they said that the internet, cell phones and air bags in cars were all unforeseeable in the 1960s (despite the fact that they either already existed or were being discussed in things like Popular Mechanics back then) but the carcinogenicity of the product, well, how could you miss it (despite the fact that it wasn't even hinted at back then precisely because of numerous tests that had come up negative)? So what granted them the power of perfect foresight though only for an obscure issue utterly tangential to their lives? Hindsight bias.

Courts in 2011 are starting to recognize the danger of unintentionally imposing a duty of omniscience if the faulty heuristic is not recognized and dealt with. See Rodriguez v. Stryker but also see Cristiani v. Money. Courts may be aware of the blindspot in our reasoning but how, within existing procedures, do you avoid it and how do you prove your jury was afflicted by it after the fact?

Prevnar and ActHIB: Here We Go, Again

Post hoc, ergo propter hoc. There'd be far fewer toxic tort claims if it weren't for that little logical fallacy which informs so many opinions.

Today there's word from Japan that the use of Prevnar and ActHIB has been suspended following the deaths of four children who died after immunization against bacterial meningitis and pneumonia. Though the vaccines came from separate lots indicating that contamination was not an issue and despite the fact that pneumonia and bacterial meningitis are dreadful diseases the news prompted the usual outpouring of vaccine denunciations.

Here in Houston the news produced claims that (a) the autism-derived and fact-free belief that children get too many shots or that they're given "too close together" means lazy doctors are to blame; (b) vaccines lower I.Q. and cause a 700% increase in cancer; (c) the U.S. Supreme Court has put us at the mercy of drug companies so that "you give those vaccines to your children at their peril"; and, (d) there's a dark conspiracy, in which the media is complicit, to bury stories about the harmful effects of vaccinations. See them all at "The MomHouston Blog".

You may not know people like these but they show up on your juries. Ignore them at your peril.

The National Childhood Vaccine Injury Act Preempts All Design-Defect Claims

Bruesewitz v. Wyeth has been decided. Though it starts out with a compelling pro-vaccine narrative the majority opinion quickly becomes a slog through proper grammar and the perils of reasoning from unproven premises. Breyer's concurrence at least digs into the danger to public health posed by the tort system though ultimately it's all about deferring to public health authorities rather than just acknowledging that you need neither a Ph.D nor an M.D. to understand that allowing the carrot of serial mega-verdicts to incentivize the trial bar into suing the vaccine makers out of business would be a catastrophe.

Things look to get interesting again once you get to the dissent. It begins by embracing the stick view of torts and economics. Specifically, that companies are not incentivized by the market to improve the safety of their products and thus they won't do so unless and until the stick of economic pain is applied to their backsides via the tort system. But then it too wanders off into an even more painful textual argument. The dissent only approaches the heart of the issue tangentially in footnote 25 when it touches upon but dismisses the risk to our vaccine system posed by something like the autism-vaccine hoax.

The dissent notes the 5,000 pending autism-vaccine claims but says that without "empirical data" worrying about such suits impacting the vaccine industry is purely speculative. The footnote goes on to happily imagine that state courts have decades of experience efficiently and effectively weeding out and disposing of meritless products liability claims summing up by saying that "doomsday predictions of ... a torrent of meritless lawsuits bankrupting manufacturers and causing vaccine shortages seems remote at best."

For some empirical data derived from past experiments with letting the tort system "regulate health care" the dissenters might try (gated) "The Negative Impact of Litigation on Women's Health Care" from the journal Gender Medicine (see also the Bendectin, breast implant and dozens of other product defect claims that drove safe and effective products off the market).

Anyway, that's it. No more design defect claims for childhood vaccines.

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More Media Coverage of Bacillus Cereus Lawsuits

MSNBC is reporting that another personal injury lawsuit has been filed arising out of a hospital-acquired B. cereus infection and that a number of would be plaintiffs are inquiring about their own claims. Meanwhile the difficulty in tracing the geneology of members of the bacillus family, and a new way forward, are coming into focus. See: "Bacillus Taxonomy in the Genomic Era Finds Phenotypes to be Essential Though Often Misleading".

A Deadly Hospital-Acquired Infection Becomes a Products Liability Claim

In today's news is a tragic story about the parents of a two-year old boy whose death from a nosocomial (hospital-acquired) infection they blame on alcohol wipes contaminated with Bacillus cereus.  According to the complaint filed February 13th in federal court here in Houston the Kothari's son developed bacterial meningitis following an otherwise uneventful craniotomy performed at Children's Memorial Hermann Hospital for a benign arachnoid cyst.  During the course of his treatment alcohol pads and swabs were used on his surgical wounds and within days he developed a B. cereus infection (established by positive cultures from cerebrospinal fluid) and died shortly thereafter. The next month Triad, alleged to have been the manufacturer of the alcohol pads and swabs, recalled the products saying they were potentially contaminated with B. cereus. Two days later the FDA announced a recall of all such Triad pads and swabs saying that their use "could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients." 

It's estimated that in the U.S. two million patients are sickened and 80,000 are killed annually by nosocomial infections. Accordingly, it's a very big problem and so has the potential to be a very big mass tort.

Yet a big part of the problem, and the biggest impediment in the past to tort claims arising from these illnesses, are the twin issues of tracing the infection to a putative source and then establishing that the bacteria cultured from the victim are the descendants of bacteria found in the defendant's products or at its manufacturing facilities. Since most bacteria responsible for nosocomial infections, including B. cereus, are ubiquitous in the environment and were, until recently, impossible to distinguish phylogenetically, establishing causation has been essentially impossible. Now, thanks to epidemiology returning to its humble origins and genetic sequencing taking giant strides forward, it may be possible to trace an infection to its origin and conclusively establish ancestry.

Unfortunately the Kothari complaint does not reveal whether or not anything beyond a post hoc ergo propter hoc inference supports their claim. One allegation is that B. cereus infections are rare in hospitals and yet the first thing that pops up on PubMed is "Bacillus cereus Bacteremia Outbreak Due to Contaminated Hospital Linens". And as to the proposition that B. cereus infection is somehow unusual and thus more likely due to something gone astray see "Bacillus cereus, a Volatile Human Pathogen". Finally, as to the claim that B. cereus meningitis in children is exceedingly rare see (ungated) "Bacillus cereus Bacteremia and Meningitis in Immunocompromised Children".

Did the hospital have a record of B. cereus infections? Were catheters employed that B. cereus could have used as an escalator to infection? Was the strain identified identical to the one that prompted the recall? Were there other sources of that strain? If so, how is one deemed more likely the cause than the other?

Efforts to identify strains of disease-causing bacteria and to trace them back to their origin have put us on the verge of being able to identify and hopefully thereupon eradicate the causes of an enormous portion of human suffering. But we're not quite there yet as demonstrated by tonight's report of the National Academy of Sciences on the 2001 anthrax attacks. B. cereus is a cousin of B. anthracis - the causative agent of anthrax. B. anthracis was long thought to be less promiscuous than its cousins and so less likely to vary widely thus making its origin easier to identify. But it ain't so. See Chapter 5.2 "Identification of the B. anthracis Strain". The very same difficulties will likely hamper any attempt to match strains of B. cereus.

Establishing a common strain of bacteria and tracing it back to a particular defendant remains a very high hurdle for any plaintiff to clear. But when the day comes that both are readily doable "Katy bar the door" because the number of deaths from cancer, heart disease, diabetes, etc being laid at the feet of infectious agents is staggering and rising every day. Worst of all, thanks to the ability of these ancient predators to evolve at a fantastic rate. there's little anyone can do to predict where and from which formerly benign little bug the next onslaught is likely to arise.

Will the EPA Disclose Confidential Business Information?

For the first time since enactment of the Toxic Substances Control Act (TSCA) the US EPA is threatening to remove confidentiality claims on studies of 14 chemicals.

Under the TSCA companies may claim that information submitted to the EPA should be treated as confidential business information (CBI) and not disclosed to the public. Companies that manufacture, process or distribute chemicals are required to immediately notify the EPA if they learn a chemical presents a substantial risk of injury to health or the environment. The reports are available on EPA’s website, but when the identity of the chemical has been claimed confidential by a company, the name of the chemical has been removed from the copy of the report that is made public.

In May 27, 2010, the EPA said it planned to generally deny confidentiality claims for and the identity of chemicals in health and safety studies filed under the TSCA, except in specified circumstances.

The EPA has begun reviewing past CBI claims for chemical identity in health and safety studies. When the EPA determines that the information is not eligible for confidential treatment under the law, it will notify companies of the determination and that it will make the information public on the 31st day after receiving the determination unless the company properly challenges the disclosure.

On February 10, 2011, the EPA notified five companies that the identities of 14 chemicals associated with a number of health and safety studies under TSCA are not eligible for confidential treatment. The companies that submitted the data in question are: Givaudan Fragrances Corporation, Japan Technical Information Center, Inc., JSR Micro, Inc., Nalco Company and Promerus LLC.

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The Man Who Didn't Fall

On the matter of negligence in personal injury cases the first draft of the Restatement (Third) of Torts eliminated the element of duty altogether. After an uproar the authors eviscerated duty and stuck back in what was left. Ultimately, while they failed to restate the law as it pertains to duty they did manage to restate the era of unjustified fears and risk aversion that has persisted since about the time the Restatement (Second) was published.

The Restatement (Third) takes the position that case law as well as scholarship pertaining to duty is largely incoherent. The essence of the claim is that limits to liability couched in terms of relationships or foreseeability are nothing but ad hoc justifications for taking the real question, whether defendant breached a duty of reasonable care owed to society, out of the hands of the jury where it belongs. Thus, dismissing as insupportable judicial inquiries about the connectedness of plaintiff and defendant (the relational approach) as well as those as to the proximity of cause and effect (proximate cause), the Restatement (Third) of Torts, Liability for Physical and Emotional Harm Section 7(a) reads "[a]n actor ordinarily has a duty to exercise reasonable care when the actor's conduct creates a risk of physical harm." It goes on to add that save in "exceptional cases" judges "need not concern themselves with the existence or content of this ordinary duty." In other words, once it has been established that a defendant created a risk the court's work regarding duty is finished and the question of whether defendant's conduct was reasonable is exclusively for the jury to decide.

That's a very long way from either position taken in  Palsgraf v. The Long Island Railroad Company . On one side Chief Justice Cardozo for the majority wrote "[t]he risk reasonably to be perceived defines the duty to be obeyed, and risk imparts relation; it is risk to another or to others within the range of apprehension". On the other Justice Andrews dissented writing both that "[e]very one owes to the world at large the duty of refraining from those acts that may unreasonably threaten the safety of others" and yet that "there is one limitation (on liability). The damages must be so connected with the negligence that the latter may be said to be the proximate cause of the former." He continues "[w]hat we do mean by the word "proximate" is, that because of convenience, of public policy, of a rough sense of justice, the law arbitrarily declines to trace a series of events beyond a certain point."

Cardozo marks the boundary of liability by a circle of close if fleeting relationships while Andrews bounds it within a circle of causes that are close to the injury producing event. Whether measured by the remoteness of the relationship or of the cause from effect both sides agreed that there was a limit to the duty of reasonableness even when a risk has been created. It's that idea of a limit on the duty of reasonableness that was cut out of duty in the Restatement (Third). Consequently foreseeability, the catchall for the various efforts to limit the scope of the duty of reasonable care, is said to have been purged from duty.

The objection that the collection of limitations on the duty of reasonable care (whether Cardozo's or Andrews' or the many iterations based on foreseeability) is incoherent is based, I suspect, on an understandable misunderstanding of what these jurists are trying to say. What I think they've been trying to say is that risk is an inevitable part of life and that some risks are so small that liability isn't warranted even if an injury should follow their creation.

But foreseeability doesn't sound much like risk. Isn't it about predicting the future; about foretelling future events based on what's already known? Yes, but that ex ante calculation of the effects that likely follow causes is what risk is all about.

But why limit liability by the degree of risk? And if a boundary is drawn how can it be done other than arbitrarily? Isn't it better that we follow the Precautionary Principle? Aren't we Addicted to Risk? Wouldn't the world be a better place if we quit taking risks?

To answer those questions let's go back to the railroad guards who created the risk that caused Ms Palsgraf's injury. As a train began to leave the station two men ran to catch it. One safely boarded but the other, "carrying a package, jumped aboard the car, but seemed unsteady as if about to fall. A guard on the car, who had held the door open, reached forward to help him in, and another guard on the platform pushed him from behind. In this act, the package was dislodged, and fell upon the rails." What might the future have looked like had the guards taken the time to consider all of the possibilities that might follow from their effort to keep the man from falling? What might the future have held for him assuming gravity acted upon him as it did upon his package? And what about the rest of us, if inaction were the only way for our fellow citizens to avoid being hauled into court?

For several decades now the merchants of fear have been telling us that everything we thought was progress is instead the cause of human suffering. Vaccines? Autism or worse. Electricity?  Electromagnetic fields, migraines, MS, cancer. Internal combustion engines? Global warming, pm2.5, etc. Plastics? Endocrine disruption, heart attacks, cancer. Pesticides (e.g. DDT) and herbicides? Sterility, cognitive deficits, cancer, overpopulation. Cars? Runaway acceleration, rollovers, fireballs. Computers? ADHD, too many choices, too little control. Shouldn't we have waited until all the kinks were worked out before acting? Click on the vaccines link in this paragraph and also consider the price of fear of regret as expressed by Benjamin Franklin.

It is, I'm afraid, a duty to stop and not act until you've considered all the possible consequences of every action, however improbable, that the Restatement (Third) ultimately embraces. It is an embrace of the Precautionary Principle - an embrace therefore of a political viewpoint; not a restatement of the law regarding duty.

When you think of foreseeability as risk you see what the law really has to say about the duty of reasonable care and the analysis of any claim that it was breached. What it truly says is that the court, taking an ex ante perspective, is to decide whether the risk created was one for which, if found unreasonable and causative by a jury, liability may fairly be imposed. Thereafter, for any act amenable to liability, it's for the jury to express their community's tolerance for risk. Risk, or foreseeability, is thus sensibly in two places. First in the law where the limits of liability are drawn and thereafter with the fact finder who considers the reasonableness of the conduct given the context in which the various factors played out. 

Is there some bright line that can be drawn? Not always though we're certainly arguing down here that in cases where good quantitative risk assessment is available it can be. For example, in one case involving a minute exposure to a carcinogen we can take the plaintiff expert's epidemiology studies and show that the exposure his industrial hygienist calculated produced, at most, a 1 in 13 million risk of death. Compared to other known risks you're much more likely to slip and fatally hit your head on the toilet than to die from the exposure of which plaintiff complains. Our argument is that it make sense then to have the law, i.e. the court, set some reasonable outer limit on liability - perhaps at the 1 in 1 million level. Otherwise we either open up toilet makers and everyone else to ruinous liability for creating risks running towards the impossible end of the spectrum or we without any sound reason decide that some one in a million risks of death are fine while others aren't.

Unsurprisingly it didn't take long for the simplicity and predictability arguments advanced in support of the new and hollow version of risk to run off the rails. Consider Feld v. Borkowski. Iowa's supreme court eagerly adopted the new conception of duty in 2009  (see Thompson v. Kaczinski) only to start tortuously creating exceptions to it less than a year later. (Slow pitch softball is a contact sport? Who knew? By the way, with all due deference to the Creighton coach I suspect angular momentum and early application of torque rather than recklessness answers the question). Rather than clarifying duty I'm afraid the Restatement (Third) has only created a risk of even more obscure and incoherent formulations of exceptions so as to avoid the consequences of duty without limit.

Anyway, whatever the facts and whatever the content of duty courts will in the end have to recognize the wisdom of another famous American, Henry David Thoreau, who wrote "A man sits as many risks as he runs." And that "if a man is alive, there is always a danger that he may die ..." It's exactly that essence of the inevitability of risk that the courts, if not the Restatement (Third), have been trying to express when they talk about duty.

 

 

 

"Mere 'But For' Causation"

Whether a plaintiff is required to prove proximate cause in a FELA case appears to be the essence of CSX Transportation, Inc. v. McBride; a case the US Supreme Court has recently chosen to review. Specifically, the question CSX raises in its brief is whether evidence of "mere 'but for' causation" coupled with some disconnected negligent act by the railroad is enough to satisfy the requirement that plaintiff prove that the railroad's negligence was the legal cause of his injuries. However, given the growing movement to rediscover and understand anew the foundations of tort law, to think of Torts as Wrongs rather than tools to (a) allocate losses; (b) regulate on an ad hoc basis "negative externalities"; or, (c) redistribute wealth, the Court's opinion has a chance to be a very big deal should its reasoning extend beyond the interpretation of a century old statute.

If not all "but for" causes are proximate causes where does the line get drawn and why does it get drawn there? For a very long while there was no line here in Texas. Take for example the case of Dryden v. Gulf States Utilities Company - a case I monitored as a summer associate. My firm represented the workers compensation carrier which had paid indemnity and medical and was on the hook for lifetime future medical bills. It had intervened in the case to assert a lien such that were Dryden to recover by way of his "third party" action for lost wages and medical bills it would get two thirds of its money back. We played no role in the case having stipulated before trial to the amount of the lien and our recovery.

Being green and stuffed full of idealized law rather than practical law I was shocked that such a seemingly meritless case had even made its way to trial. The plaintiff was a painter and he had used what they called a pic-board, a sort of hanging scaffold with a cleat on one end of the 2" x 12" board and a hole for a rope in the other. With this setup he could pivot around and reach more places in need of paint. The day before the accident his helper saw an old rope in a trash pile and, it being much closer to hand than the one back in their truck, he retrieved it and used it to suspend the plaintiff's scaffold thirty feet up - much easier than carrying the pic-board down several flights of metal stairs and stowing it. The next morning the plaintiff saw the old thin rope supporting the pic-board and decided it wasn't sufficient so he went back to his truck and retrieved the good rope. Then he walked out on the scaffold, suspended only by the thin rope from the trash, on his way to reinforce the thin rope with the new one. The obvious happened next and the plaintiff's arm was broken in several places.

Ok, even if it was somehow negligent to discard an old rope in a temporary trash pile on its own premises how does it follow "as a natural and continuous sequence of events" that someone would fish the rope out of the trash, use it for a wholly improper purpose, be recognized as a danger and still be relied upon by a journeyman painter to prevent him from falling thirty feet to the ground? The jury found it quite foreseeable and they popped the defendant rope-discarder for $654,000. Amazingly, the jury also found that the rope failing was not foreseeable to the plaintiff even though the whole purpose of his retrieval of the good rope and walk out to the end of the pic-board was to shore up the trash rope. The court of appeals affirmed

If such an accident is foreseeable (to the deep pocketed party anyway) one has to wonder what isn't foreseeable given the common thinking error known as hindsight bias. And by the way, what is foreseeability, really?

Duty and breach, and cause and effect, are opposite sides of two different coins. To connect the two coins and so complete the tort you have to establish proximate cause which can I think be thought of as a "but for" cause such that, if it meets some criterion or criteria, the jury is permitted to apportion fault and decide damages.

If the connection is too automatic, too natural and continuous a sequence, then things are easy and the tort may even be called an intentional one. But at the other end of the train station where a tile is falling towards Mrs Palsgraf's head connections between the law and the facts, via foreseeability or otherwise, are much more difficult unless they're thought about in terms of risk. Instead the courts dance around the issue and try to come up with names for where acts fall on the spectrum of risk. A botched surgery in which the wrong kidney is removed is the easy case. A botched surgery in which the wrong kidney is removed leading to a transplant which leads to a stroke demands foreseeability. A botched surgery in which the wrong kidney is almost removed but isn't yet because the plaintiff arrives in his cab, supplied by the hospital, at an intersection one minute later than he would have had the mix-up not caused a one minute delay in the surgery, just in time for a runaway 18-wheeler to crash into him - well, that requires CSX v. McBride because the risk, ex ante, was incalculably small.

In CSX v. McBride the plaintiff didn't even try to concoct a story about foreseeability. The railroad allegedly hooked up the locomotives in a fashion which increased the risk of derailment. That was the first coin of negligence - a duty to try to avoid derailments and a breach (by the way, there was no derailment). Elsewhere, the plaintiff was driving a locomotive with which he wasn't familiar. His hand tired at the brake and eventually his reach exceeded his grasp and he hit his hand on the brake causing swelling and pain - that was the second coin - his hand was tired from working the new instruments and consequently he hit it on an unyielding metal bar after overuse. He has thus duty/breach and cause/effect. Under his theory of FELA law no connection between the two is needed. Essentially the railroad has a duty of omniscience.

The Court could, of course, decide the case strictly on whether some connection, some nexus, between duty/breach and cause/effect is required under the FELA. It produces a nice binary result. Or it could delve deeper. It could as it did in Industrial Union Department, AFL-CIO v. American Petroleum Institute, et al recognize that we live in a world of inevitable risks. That "a man sits as many risks as he runs".

Were it to do so, were the Court to find that there exists a realm of de minimis risks far beyond the mark where injury would be expected, a realm in which Americans are free to act silly (in the eyes of some) as they want so long as they don't impose a significant risk on their fellow citizens, it would be utterly revolutionary.

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A Preview of Bostic Argument?

Last Friday at the Texas asbestos MDL hearings Judge Davidson addressed arguments that preview what may be argued in the Bostic case currently pending in the Supreme Court of Texas.

At the hearing one of the defendants argued in essence that Ford Motor Co. v. Ledesma, a case that defined producing cause in a product liability case, overruled Borg-Warner v. Flores and requires that a plaintiff prove that but-for the defendant’s fiber inhaled by plaintiff, the plaintiff wouldn’t have developed mesothelioma. Ledesma stated that producing cause requires a defendant’s act or omission be a substantial factor in bringing about an injury and without which the injury would not have occurred. Ledesma was not a toxic tort case nor did it involve multi-tortfeasors. The central issue was whether a manufacturing defect triggered an axle displacement and caused the accident or whether the axle detached as a result of an accident. In Ledesma there was a causal chain of events which could be fairly tracked for a determination of which of the actions was or wasn’t a but-for cause.

Judge Davidson disagreed with this interpretation and stated that substantial contributing factor as annunciated by the Supreme Court of Texas in Borg-Warner didn’t require that a plaintiff prove but-for a defendant’s exposure the mesothelioma would not have developed. The proposed interpretation would require that but-for causation in asbestos cases must be shown by proving that a defendant’s product was a link in the actual chain of causation, i.e. the fiber that started or actually contributed to uncontrolled cell growth.

We believe the Supreme Court of Texas may reach the same result if it grants the petition for review in Bostic.  Strict but-for causation is simply not possible in a classic Summers v. Tice, multi-tortfeasor scenario. The high court in Borg-Warner clarified that in those situations which often arise in asbestos cases you need to examine the risk imposed on the plaintiff by the defendant’s conduct. Because in a toxic tort case with multiple exposures, it is practically impossible to determine which fiber or set of fibers are in the actual causal chain, risk becomes a proxy for cause. A but-for cause can then be proven by showing that an exposure increased the plaintiff’s risk to a point that it was likely a but-for cause. This is done in the first instance by quantifying the dose of exposure through an industrial hygienist. However, that is not the end of the inquiry. The Supreme Court of Texas in Borg-Warner also recognized that a defendant’s conduct must have been a substantial factor, which is shown by evidence that the risk imposed on the plaintiff by the defendant’s conduct was itself substantial.

Ledesma is of course important. An exposure must be a but-for cause, however, in toxic torts with multiple exposures, a strict factual set of causal links is pragmatically impossible. Risk has long been the proxy and should continue to be the necessary proxy.

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Nulliparous Plaintiffs, Fault and Causation

It has been known for a couple of decades now that women who never have children (i.e. women who are nulliparous) and women who do have children but not until they are 30 or older suffer a striking increase in their risk of developing breast cancer. The evidence for the association between never giving birth or delaying having a child continues to accumulate and now it appears that the increased risk is focused on hornmone receptor-positive breast cancers. See "Associations of Breast Cancer Risk Factors With Tumor Subtypes: A Pooled Analysis From the Breast Cancer Association Consortium Studies" in the current issue of the Journal of the National Cancer Institute. So let's say you've got a nulliparous plaintiff alleging that your drug or device or chemical caused or accelerated her hormone receptor-positive breast cancer; how do you handle her status?

The first problem a defendant faces in such a case is the risk of inadvertently wandering into the minefield called "blaming the victim". The plaintiff has either freely made a choice or has tragically been unable to have a child. Either way the jury will react strongly and negatively to any discussion about parity status and causation that makes even the slightest trespass into the issue of fault. Keep the discussion limited to risk factors and their relative potency. But that leads to another problem.

In some of the jurisdictions in which I practice plaintiff's counsel will successfully argue to the trial court that only evidence about about the actual cause of plaintiff's injury is admissible. In other words, unless my expert is prepared to say e.g. that "to a reasonable degree of medical probability plaintiff's breast cancer was caused by her not having children when she was young" testimony about "mere risks" is irrelevant and so inadmissible. The practical effect of such a ruling is that only junk science is admissible on the issue of the actual cause of plaintiff's cancer since my experts tend to be modest about the claims science can make regarding the cause of any individual's cancer. We're stuck then trying to prove a negative, showing we acted reasonably and preserving error.

In this age in which much that was certain (e.g. that we've conquered infectious diseases) is proving not to be so it's time I think for courts to recognize not only that the reasonableness of actions can fairly and effectively be judged according to the risks they conferred but also that causation is in many cases most precisely weighed when competing risks are allowed to be compared against one another.

Finally, and hopefully still on topic, for more evidence of the complexity of causation see "Does Pregnancy Provide Vaccine-Like Protection Against Rheumatoid Arthritis?" Why would pregnancy protect against auto-immune disorders and what's the connection with breast cancer? There are a variety of hypotheses offered but so far no one knows.

 

Are Jurors Getting Better at Spotting Junk Science?

The answer is: maybe, but only when it comes to the really obvious stuff.

In this month's journal of Law and Human Behavior there's a new paper reporting on a study designed to test jurors' ability to discern and deal with bad science. It's titled "I Spy with My Little Eye: Jurors' Detection of Internal Validity Threats in Expert Evidence". The researchers hypothesized that mock jurors could spot glaring flaws but not subtle though equally fatal ones. They also hypothesized that jurors would, when unable to judge the soundness of a scientific paper, use its publication status as a sort of seal of approval for its validity. Their results confirmed their first hypothesis but partially rejected their second one and along the way seemed to confirm the view that the less people understand about science and the scientific method the less impressed they are with publication status. Indeed, unpublished science may well be viewed as "cutting edge" and so, like soap powder, "New! And Improved!"

It's a well done paper; infinitely better than so much of the Empirical Legal Silliness out there. It also provides a measure of hope about jurors' ability to deal with scientific issues. For example, these mock jurors were able to identify and discredit a study without a control group. Using data demonstrating  e.g. that 18% of type II diabetes patients taking drug X had heart attacks or strokes over the following decade to show that a particular plaintiff's heart attack was caused by drug X is of course just a version of the post hoc ergo propter hoc fallacy unless there's some similar group of type II diabetics not on drug X who didn't suffer such a high rate of heart disease and stroke.

On the other hand, more subtle but equally invalidating flaws like obvious confounders, biases and reversal of causation went undetected. These observations led the authors to conclude that "[o]ur results indicate that although jurors may be capable of identifying a missing control group, they struggle with more complex internal validity threats such as a confound and experimenter bias. As such, the role of traditional legal safeguards against junk science in court such as cross-examination, opposing expert testimony, and judicial instructions become increasingly important." These findings and others like them underscore the continuing need for judges to act as gatekeepers. Such objective findings also continue to undercut the fact-free reasoning behind Comment c. Toxic substances and disease, Section 28. Burden of Proof, Restatement (Third) of Torts and its effort to loosen the standards for admitting expert testimony in toxic tort cases.

But how are our judges doing? Are they starting, at last, to "get" science? Seventeen years ago in Daubert v. Merrell Dow Chief Justice Rehnquist wrote, concurring in part and dissenting in part, "I defer to no one in my confidence in federal judges, but I am at a loss to know what is meant when it is said that the scientific status of a theory depends on its "falsifiability" and I suspect some of them will be, too." That a Justice on the U.S. Supreme Court could not understand that the demarcation between science and pseudo-science had something to do with being able to test the theory being advanced was shocking in 1993. Surely judges are getting this concept first introduced in middle school. Alas that it is not so. One of the references in the paper above is to a study that found that only 5% of state court judges "demonstrated a clear understanding of falsifiability". Worse yet, 80% of the same judges were confident they were up to the task of gatekeeping.

What does it all mean? I think it means that the battle against junk science is far from over but that lay people are finally becoming a little more skeptical of scientific claims and are at last learning to distinquish between the junk and the science, at least on a rudimentary level.

"I'll Never File Another Asbestos Case in Texas"

That's what a plaintiff's lawyer who's made a fortune filing asbestos claims in Texas announced recently. Could it be that the fifth decade of asbestos litigation in Texas will be its last? It's starting to look that way especially after a conversation I had over drinks last week.

I was talking with a long time adversary and asked what his firm's founder was up to and what he thought about tort reform, Borg-Warner v. Flores and the MDL. His response was an epiphany. He said that the old man is and has always been a businessman. He never had anything against the companies. "He just saw back when Texas was a blue state that the courts were going to start redistributing the wealth and that the middleman would get 1/3 of every dollar redistributed. Now that Texas is a red state he owns  [several business interests] 'cause that's where the easy money is being made nowadays."

Whatever their original intent the courts created a huge, unregulated and readily exploitable market in asbestos litigation. The entrepreneurs only played their part. Nothing personal, it was only business.

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Peter Infante Isn't Happy About IARC's 2009 Benzene Evaluation

A member of NIOSH's 1975 Benzene Task Force and long-time plaintiff expert, Infante has written essentially an editorial comment about IARC's determination that there is only limited evidence for benzene causing blood cancers other than AML (or ANLL or whatever it's called this week). It's published online first in the American Journal of Industrial Medicine as "The IARC October 2009 Evaluation of Benzene Carcinogenicity was Incomplete and Needs to be Reconsidered."

Infante was on plaintiff's team in the case that resulted in the biggest check ever written to a single plaintiff in a benzene case - Mason v. Texaco.

What To Do About Too Many Calories for "Sedentary Young Children"?

The Center for Science in the Public Interest (CPSI) has sued McDonald's over their Happy Meals. The complaint argues that Happy Meals are "unhealthy" and cause obesity, that its marketing is "unfair" because it makes six year old lead plaintiff Maya pester her mother with her "clamor for Happy Meals" and that McDonald's seeks by way of its Happy Meals, like James Dean before it, "to subvert parental authority".

There is much in the complaint to blog about. Far too much actually given that I've got a brief due in the Texas Supreme Court by Friday. For now though consider the claim that Happy Meals provide too many calories for the typical, which is to say sedentary, child. When and how did the typical child get to be sedentary and so at risk of obesity? I'd argue that it has everything to do with turning schools into warehouses for children.

Want some evidence that even moderate exercise protects children from overeating or too much TV/video-gaming? See "Health Status and Behavior Among Middle-School Children in a Midwest Community: What are the Underpinnings of Childhood Obesity?" See also "The Fat-Mass and Obesity-Associated (FTO) Gene, Physical Activity, and Risk of Incident Cardiovascular Events in White Women". Apparently the "fat gene" only causes problems when combined with inactivity.

All in all it looks like the solution to childhood obesity is more about revving up the body's engine than starving it of fuel.

Wyeth v. Rowatt: Substantial Confusion About Causation

Reading and re-reading and even re-re-re-reading the Nevada Supreme Court's opinion in Wyeth v. Rowatt only leaves me more perplexed about Nevada's take on causation in pharma/toxic tort cases. Typically a plaintiff must prove that if she hadn't been exposed to defendant's product she'd have been better off. In other words, defendant's product was a "but for" cause of her injury. There are of course cases that relieve plaintiff of having to prove to which of several defendants' identical products she was exposed (e.g. Sindell v. Abbott Laboratories) but she always has to prove, irrespective of who made it, that the product complained of is actually what made her ill.

The court in Wyeth v. Rowatt held that the following jury instruction was either OK or at least not harmful: "A legal cause of injury, damage, loss, or harm is a cause which is a substantial factor in producing or promoting the injury, damage, loss, or harm." Nevada has an instruction on "but for" causation and plaintiffs and defendant all requested it. However, the trial court instead gave a modified pattern jury instruction for substantial factor causation that reflected its understanding of the promoter theory of carcinogenesis - the idea that some things initiate cancer and other things propel or promote it, with hormone replacement therapy allegedly falling into the latter category - and stuck it not into the pattern instruction for "but for" causation but rather into the instruction on substantial factor causation. The pattern substantial factor causation instruction is to be used when the jury is confronted with two competing causes, either of which "would have been sufficient to cause the injury".

How can a promoter be a sufficient cause? It can't of course, but that's just a quibble about loose language. The real problem is that any sufficient cause, absent a superseding cause, is necessarily the "but for" cause and "substantial factor causation" is just "but for" causation + reasonableness so why not require the "but for" instruction in either instance unless you're watering down the causation standard?

In Texas we had an instruction similar to that used by the trial court in Rowatt. It was the old instruction for a "Producing cause" and years of jury trials and focus group experience conclusively demonstrated that the instruction - "Producing cause' means an efficient, exciting, or contributing cause that, in a natural sequence, produces the incident in question. There may be more than one producing cause" - led jurors to believe that they were permitted to find causation whenever the putative cause might have or could have been one among a constellation of possible causes. The Texas Supreme Court finally made the instruction conform to the law in 2007 with it's opinion in Ford Motor Company v. Ledesma writing that the components of a producing cause are "that (1) the cause must be a substantial cause of the event in issue and (2) it must be a but-for cause, namely one without which the event would not have occurred."

Within the Rowatt opinion is a brief discussion of risk but rather than using it to inform the state's "substantial factor causation" jurisprudence the court instead held that a four-fold increase in risk claimed by plaintiff's expert somehow made the lack of the "but for" instruction harmless. So are they saying that anytime relative risk is above two, causation is established? They don't say anything like that and even if they did it still has to be (everywhere else) a "but for" cause. The big risk increase is just a way to satisfy the preponderance of the evidence burden on "but for" causation.

If you've got an insight into how Rowatt fits within a modern conception of causality in the law I'd appreciate it if you'd drop me an email re: same.

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Baron & Budd Takes Georgia-Pacific v. Bostic to the Supreme Court of Texas

Georgia-Pacific v. Bostic, which prompted us to write The End of Toxic Tort Litigation in Texas? may be on its way to the Texas Supreme Court. Here's Baron & Budd's Petition For Review. Bostic is a mesothelioma case in which plaintiff prevailed at trial against a peripheral defendant but lost the claim on appeal when the Fifth Court of Appeals held that she had failed to prove that her decedent's exposure to that peripheral defendant's product was a "but for" cause of his fatal cancer.

Bostic's best argument is that the application of a "but for" standard of causation to a particular exposure by the appellate court makes it impossible for any toxic tort plaintiff whose illness was allegedly caused by one or more of several exposures to prevail. Here, plaintiffs get it exactly right. Whenever plaintiff's injury has been proved to have been caused "but for" a bullet (as in the "one hit" case of Summers v. Tice) or "but for" a sufficiently high concentration of salt (as in a cumulative injury as in Landers v. Texas Salt Water Disposal Co.), and where each actor's conduct was tortious, plaintiff is relieved of the logically impossible task of proving that each tortfeasor's conduct was a "but for" cause. The Texas Supreme Court has already made this point in in the asbestos context in  Borg-Warner v. Flores.

Baron & Budd gets it wrong however when they argue that (1) Borg-Warner only demands a Lohrmann-esque frequency, regularity and proximity exposure qualification in malignancy cases in general and in mesothelioma cases in particular; (2) that dose, and therefore risk, quantification is only required when the parties dispute what, in general, caused plaintiff's injury (e.g. it ought not be required when the parties agree that asbestos exposure was responsible for a plaintiff's mesothelioma); and, (3) that the standard for substantial factor causation somehow changes according to the facts of the case.

The whole point of Borg-Warner and the almost two decades of Texas Supreme Court cases that preceded it is to put the requirement for demonstrating wrongful, unreasonable conduct back into the state's law of torts. For Georgia-Pacific to have prevailed on appeal it should have been because its product posed at most a de minimis risk of mesothelioma,.not because plaintiff couldn't prove that its asbestos contributed to Bostic's cancer.  

If all your product poses is a vanishingly small risk of harm, in this a world of inevitable and uncountable risks, then you've acted neither unreasonably nor wrongfully and the substantial factor test, which is a combined query about causation and legal responsibility, will decide the matter and you'll not be deprived of your property. It's precisely because calculations of risk (the measure of the reasonable man and which are derived from estimates of dose) often show peripheral defendants to have acted neither wrongfully nor unreasonably that plaintiffs' counsel hate dose estimation.

New Voir Dire Question: Do You Own Shares in Any Lawsuit?

Mass tort litigation is big business. In the past, thanks to rules prohibiting fee sharing with non-lawyers, it was a big business in which only lawyers could participate. Not anymore; at least not if you're in private equity, a hedge fund or are a bank. All it takes is cash, high tolerance for risk and an appetite for big returns.

Today the NYTimes has an excellent (save for one common misperception) article on the subject: "Putting Money on Lawsuits, Investors Share in the Payouts".  My quibble is with the claim that the money pouring into investments in contingent fee recoveries "... is helping to ensure that cases are decided by merit rather than resources ". It's not true and hasn't been for decades; at least not for the big dogs and not for mass tort cases. They already (a) have bigger and faster jets than the companies they're suing; (b) own or control their own banks; (c) only have to focus their efforts in one jurisdiction; and, (d) can readily syndicate really big cases within a network of very business savvy lawyers. Those entrepreneurial lawyers who started all this vowed long ago never to be outspent and I've yet to see it happen.

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Childhood Leukemia and Population Mixing: The Evidence Mounts

Despite numerous attempts to blame anything and everything associated with a deep pocket for a cluster of childhood leukemia cases in Fallon, NM,  the strongest evidence by far supports the hypothesis that an infection, spread by the sudden mixing of two or more populations, was responsible. Now there's evidence that childhood leukemias previously blamed on nearby nuclear reactors are in fact strongly associated with population mixing. See "Childhood Leukaemia, Nuclear Sites, and Population Mixing".

That introducing lots of new workers to a formerly rural environment to build a military base or nuclear power plant often is accompanied by an increase in childhood leukemia cases is now confirmed by more than a dozen studies. That often unnoticed infections cause cancer is also well established. So, what duty, if any, is owed to the local children and to the children of its own employees when a business sets up say a slaughterhouse in rural North Carolina and staffs it with workers from a long way away? And if there is a duty, how is it to be fulfilled? To warn? Of what? To monitor? For what? To protect? With what?

Texas Supreme Court Declares a Provision of House Bill 4 Unconstitutional

Last week in Robinson v. Crown Cork & Seal the Texas Supreme Court provided an in depth analysis of the constitutionality of retroactive laws and held that the “innocent successor” limit on liability for asbestos-related personal-injury claims included in House Bill 4 is an unconstitutional retroactive law. The Supreme Court concluded that Texas Civil Practice & Remedies Code Chapter 149, which the Legislature enacted as part of the 2003 tort reforms “significantly impacts a substantial interest” that Robinson had in a “well-recognized common law cause of action” for asbestos claims.

The Court also concluded that “the public interest served by Chapter 149 is slight,” rejecting the 14th Court of Appeals' holding that the purpose for which the statute was enacted is a valid exercise of the Legislature’s police power. In the opinion the Court compares this case to other analogous opinions which established that the constitutional prohibition against retroactive laws “protects settled expectations that rules are to govern the play and not simply the score, and prevents the abuses of legislative power that arise when individuals or groups are singled out for special reward or punishment.” The Supreme Court cited three factors to be considered in determining whether a statute violates the Texas Constitution’s prohibition against retroactive laws: 1) the nature and strength of the public interest the statute serves as evidenced by the Legislature’s factual findings; 2) the nature of the prior right that the statute impairs; and 3) the extent of the impairment of that right.

In a dissenting opinion Justice Wainwright wrote, “The Court’s new balancing test reaches the wrong result” and ignores an important principle. Justice Wainwright goes on to state that “[t]he constitutional retroactivity doctrine does not protect an asserted entitlement to property one does not own, and until a final judgment in the case, we do not know whether a claim will be vindicated or refuted.”

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Why So Much Peer Reviewed Science Is So Wrong

Ever since Daubert , lawyers have been fending off motions to exclude by proclaiming that the scientific studies on which their experts relied were peer reviewed and thus unassailable. Sadly, judges tend to think that a peer reviewed paper must indeed be some incremental addition to the field's body of knowledge. But are the claims in a paper that's been peer reviewed guaranteed to be true? No. But surely they're at least likely to be true, right? No. In fact, the conclusions reported in most peer reviewed scientific literature are wrong. Even those papers published in the journals with the highest impact factors are either wrong or have never even been tested an alarming percentage of the time.

Peer review is not some sort of certification of a high truth value for someone's research. Peer review exists to make sure no paper gets published whose author had gone about measuring temperature with a yardstick.

Science these days isn't what it was 100 or even 25 years ago. Seldom is what's found in prominent journals simply the reporting of observations (e.g. mesothelioma in a 2 year old girl) or the results of laboratory experiments (e.g. drinking an petri dish of H. pylori and developing peptic ulcer). In recent decades "science" has come to mean in many, many cases the sifting and re-sifting of data until some result so unlikely to have been due to chance alone appears. That result is then deemed knowledge.

But how unlikely, how very rare, must the result have been before it's crowned "Truth"? As unlikely, as rare, as being dealt two pair in a 5 card poker hand.

If you've ever played poker and bet the house on such a hand you're probably homeless. On the other hand, if you've made a living peddling liability theories resting on such odds down at the courthouse you're likely to have several homes.

Anyway, if you want to read about how science went so wrong and why, you can't do better than "Lies, Damned Lies, and Medical Science" just published in The Atlantic. It's the best and most important article you'll read this year about the current state of medical science.

Toxoplasma gondii: Sheep and Goats Have a Vaccine Against It. Why Don't We?

It''s becoming apparent that Toxoplasma gondii is responsible for an awful lot of human suffering around the world. The parasitic organism causes birth defects and spontaneous abortions, neurolgical impairment, eye damage and is increasingly suspected in Alzheimer's, schizophrenia and Parkinson's.

T. gondii infects human cells and reproduces within them eventually setting up shop in cysts throughout the central nervous system, heart, muscle, bone marrow and other organs. Persons infected are infected for life. Human infection is most commonly the result of consuming un-/under-cooked cyst-bearing meat though contact with the feces of animals, especially cats, T. gondii's ultimate host, are another avenue of exposure.

While 11% of Americans are infected with the parasite, that figure rises to as high as 70% in some South American countries. The European Food Safety Authority, worried that foodborne infection by T. gondii is on the rise and is responsible for significant yet underreported and undetected diseases within the EU, has recommended Toxoplasma monitoring of lifestock. Recent estimates of the impact of T. gondii-induced disease reveal it to be "one of the most significant causes of foodborne disease worldwide."

The good news is that thanks to demand from sheep and goat producers there's a vaccine that works well in sheep and goats. The problem is that it's a live cell preparation like the Sabin vaccine discussed during oral argument in Bruesewitz, et al v. Wyeth, Inc.,So what's the problem? The problem is that while it works really well, much better than bits of a dead organism, it's more likely to cause adverse effects. Meanwhile, finding all the bits of a dead organism that prime the immune system while weeding out those that might produce harm is a terribly complicated and expensive process. Add to that the threat posed by litigation over the inevitable errors in science's slow but steady progress through trial and error and it ought not be surprising that sheep and goats get protected while human suffering due to T. gondii spreads.

For a new, free and enlightening paper on the topic see "Vaccination Against Toxoplasma gondii: An Increasing Priority for Collaborative Research?"

Really? The Maker of the Sabin Polio Vaccine Should Have Been Subjected to Ruinous Liability?

Bruesewitz, et al v. Wyeth, Inc., et al just had to be bloggable but at first glance the debate appeared to rest largely on the interpretation of a typically modern law in which Congress had produced (probably intentionally) an incoherent mess. Digging further into oral argument, the government's claim that the CDC regularly updates its advice on the best and most efficacious vaccines in its Morbidity and Mortality Weekly Report (MMWR) looked promising until I read a few issues. Perhaps the kindest thing that can be said is that the government significantly overstated its case. Yet finally, around page 55, I found something worth blogging about.

The question put to plaintiffs' appellate counsel was as follows: "Under your understanding of [the vaccine compensation] scheme, if a person suffered a very serious injury as a result of the Sabin vaccine during the period when the CDC recommended that over the Salk vaccine, would that injured person have a claim for desing defect if the person could produce experts who said the CDC was wrong ...?" "...but your answer to my question is that [under your interpretation] that would permit a lay jury relying on experts produced in court, [to find that] the CDC got this wrong; [that] the Salk vaccine was really the better one." To which plaintiffs' counsel responded "Yes, yes, that would be a viable design defect claim."

Wow. You should read up on the Sabin and Salk vaccines and why the OPV was recommended despite the attendant risks. Would the world really have been a better place with thousands more children in iron lungs? Would Congress really want the maker of a vaccine against a modern scourge like HPV subjected to jackpot justice so that other vaccine makers abandon the promising field of anti-cancer vaccines? Would the people?

I'm just glad I grew up in an age when common sense trumped hysteria so that I could get my sugar cube.

 

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Liability for Changing Someone's Ethics?

What if there was a drug that could change a consequentialist into a deontologist? In other words, what if you gave this hypothetical drug to someone and he went from being a "needs of the many outweigh the needs of the few" sort of guy to a right v. wrong, rules sort of guy? Now what if that drug was prescribed based soley on the perfectly sound decision to relieve him of depression?

To grossly oversimplify, giving serotonin-boosting anti-depressants turned consequentialists (yes, I know there are more flavors of them than of ice cream at Baskin-Robbins but those flavors are just their common deontological side peeping through in different places) into right/wrong thinkers. Better (depending upon your perspective) yet, it made them more rational in "the greatest misfortune that may befall a man is great good fortune for his neighbor" sorts of experiments in which people are tested to see if they'd cut off their own noses to spite their neighbor's face. See: "Serotonin Selectively Influences Moral Judgment and Behavior Through Effects on Harm Aversion". ht: Marginal Revolution

Those are pretty big changes. They affect politics, friendships and so world views. I brought it up though not to discuss liability for making or prescribing such beneficial medicines but rather, I must admit, for a wholly different purpose - to very briefly discuss picking a jury. My number one rule of jury selection, from the defense perspective, is to identify and get rid of depressed veniremen. They tend not to care about rules and to be far too willing to cut off your client's ear and thereafter paint their masterpieces out of piles of her money.

Avandia: A Fair Cop?

Without a randomized controlled trial we may never really know the answer to that question though maybe the complex systems / molecular biology people will get it worked out one of these days.

We will however get to find out if the data on which the RECORD trial (Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes - don't ask me how that works out to "RECORD") was based had been properly characterized before being analyzed. In "Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration", the announcement of new tighter restrictions on Avandia and the end of the TIDE trial, it was also disclosed that the FDA "is requiring an independent readjudication of end points at the patient level" of the RECORD trial's data. While the RECORD trial apparently established the noninferiority (NI) of Avandia versus the standard treatment, claims of design flaws that biased the results in favor of Avandia, data cherry-picking, and worse were subsequently raised (see "The Doctor Doth Protest Too Much, Methinks") .

What all this dredging and now reclassification-to-be-followed-by-redredging will reveal is anyone's guess and at best it will only lead to a posthumous vindication. The more important question is how will the battle between those who hold epidemiology to be a source of actionable knowledge and those who hold it to be a source of testable hypotheses play out. On one side of the debate, at least in the Avandia context, are idealistic academics. Their presentations to FDA were filled with lots of exclamation points, suspicions and worries about the rich and powerful exploiting the poor, sick and vulnerable. On the other side are the practitioners, pragmatists and industry scientists. They (to ruin my metaphor) played Spock to to the anti-Avandia group's Captain Kirk.

Will Avandia wind up with a pardon? If so, this episode may in hindsight turn out to have been the last stand for a methodology that for 40 years reliably generated the "knowledge" needed to support a particular world view; a methodology which has now gone decades without a big hit (e.g. asbestos). If not, and should Dr. Nissen's view prove to be the accepted one, the conclusion that the approval of Avandia was "one of the worst drug safety tragedies in our lifetime" resulting in up to 47,000 needless heart attacks could reignite a "science" that for three decades ushered in wave after wave of mass tort litigation. Whichever way it turns out I'm guessing it'll be Avandia's lasting legacy.

 

Trichloroethylene + Gene Variant = Renal Cancer?

Workers exposed to trichloroethylene (TCE) who carry at least one copy of the GSTT1 allele are reported to have an 88% increase in risk of renal cancer in the new paper "Occupational Trichloroethylene Exposure and Renal Carcinoma Risk: Evidence of Genetic Susceptibility by Reductive Metabolism Gene Variants." Those workers without the polymorphism had a slight decrease in risk. Given that the allele occurs on a gene coding for cysteine β-lyase, which plays an important role in the metabolism of TCE among other molecules, the finding demonstrates biologic plausibility as well as increased risk.

So back to yesterday's post about risk : which risk, if any, would be relevant in a TCE toxic tort case? The risk given to all workers collectively; the risk at a particular range of exposure; the risk given to those carrying the polymorphism; or, the risk to those with the polymorphism exposed at high levels? And could it be the case that one risk is relevant to the question of whether a defendant's conduct was reasonable while another was relevant to the question of causation? How would that work?

However it works, as the causes of individual susceptibility are identified expect these sorts of challenges to multiply. 

When You Have to Prove a Doubling of the Risk Ask "For Whom and During What Time Period?"

Despite the fact that the Texas Supreme Court in Merrell Dow Pharmaceuticals, Inc. v. Havner wrote "[w]e do not hold, however, that a relative risk of more than 2.0 is a litmus test..." many lawyers and some courts believe that Havner (and even Daubert) require that plaintiff establish epidemiological evidence of a "doubling of the risk" before she can establish so-called specific causation. In my view all those two courts ever said was that if you wanted to play the game of epidemiological causal inference then you had to play by epidemiology's rules; and, furthermore, that if all you had was probabilistic evidence then that evidence had better show that defendant's product probably did it.

Whatever the interpretation, we mass tort lawyers often wind up fighting over whether there has been a doubling of the risk. One thing we're just beginning to fight over is "when do you measure the risk?" Take for instance the Women's Health Initiative and hormone replacement therapy (HRT).

Depending on when you decide to look HRT either caused an 80% increased risk (after one year of treatment) of coronary disease or a 30% decreased risk (after five years) of coronary disease. So how do you choose which risk is the "real" one?

In what promises to become an epidemiology blog posted for free at Epidemiology is a copy of "The Hazards of Hazard Ratios". In it the author makes the point that hazard ratios, an approximation of risk ratios, often vary over time and may be subject to biases, as when, hypothetically, over time the exquisitely sensitive, by virtue of suffering the malady earlier, manage to be deselected from subsequent years' calculations.

The phenomenon is well known to those doing benzene litigation. Had the study of the Pliofilm workers been done today the very same cohort would demonstrate a relative risk less than 2.0 quickly trending towards 1.0. The obvious retort is that "latency" somehow is responsible but that doesn't explain the fact that no member of the cohort has developed leukemia in decades. The most sensible answer is that those susceptible of getting it get it and those who aren't don't just fail to get it - they can't.

In other words, the distinction in toxic torts between "general causation" and "specific causation" is likely often (if not usually) a false one. Thanks to the laws of physics, bullets can reliably be said to be a general cause of bullet holes in people since all are susceptible to the effect. The same cannot, however, be said of benzene or HRT. Apparently they only increase the risk (perhaps to 1.0) in those people who, due to genetics, epigenetics, microbiota, environment or some other factor(s), are primed to produce the effect while simultaneously imposing an increase of 0.0 on everyone else.

So how, other than flawed post hoc "reasoning", do we determine whose injury was caused but for an exposure? Biomarkers have clearly failed of their promise. Now what? The way things have been going I bet it'll look something like this: "Discovering Graphical Granger Causality Using the Truncating Lasso Penalty" but maybe we'll get lucky and it'll look more like: "Causal Diagrams and Change Variable". In the meantime plaintiffs without biomarkers need to do a better job of demonstrating how they are like those in the time interval with the biggest risk.

Thinking About Risk

What does it mean to say that I've given someone a 1 in 1 million risk of death? Is he now just 99.9999% alive? Is he 0.0001% dead? Is either a "loss"? Must we await the verdict of the Fates to decide the reasonableness of my conduct? If so, why does some other agency decide whether an act in the past was good or bad?

What does it mean to say that I've given one million customers a 1 in 1 million risk of death? Is my conduct judged myopically on the basis of the one who died; or, shall we consider the 999,999 who wound up with a useful product and suffered no harm? And how is my conduct to be judged? Shall we add up all the good, subtract out the bad (consequence's books having been audited by the trial court), and have the jury decide whether my decision-making was, being Monday morning after all, "good" in light of the final tally?

If 1 in 1 million is too risky then so is getting out of bed in the morning. Yet 1 in 1 million is 300 American lives nonetheless. And if 1 in 1 million is a reasonable risk why isn't 1 in 100,000 or 1 in 1,000 or 1 in 10? Where do we draw the line, and why?

Does it, or should it, make any difference whether I actually knew the person on whom I imposed a risk? Does the answer change if the risk materializes? Does it, or should it, make any difference whether I actually estimated the risk before imposing it? Why do jurors punish the diligently knowledgeable while being far less wrathful towards the consciously ignorant? What, if anything, should the law do about it?

Ultimately, how should courts deal with the risks we impose on each other in this world of inevitable risks? A very good discussion can be found in "Statistical Knowledge Deconstructed".

I have one quibble and a few takes. First, the effort seems sometimes to be aimed at reconciling a Bayesian decision-making approach ("degress of belief" tending to sound rather appealingly deontological to me) with a consequentialist ex post assessment of the ultimate utility of an act. Consequentialism isn't generally thought to be informative on the ex ante side of decision-making - thus my objection to "... I mean to endorse an epistemic and (thusly) Bayesian conception of risk, not a frequentist conception". Second, his comments about cost/benefit analyses are dead on. Companies are abandoning the process and adopting "Nobody gets hurt, ever!" policies instead. One has to wonder about a legal system that advantages willful ignorance. Third, his suggestion that we let risk more openly inform determinations about where an act falls along the intentional - reckless - negligent - non-negligent spectrum would be especially helpful in mass tort cases in which risks are widely distributed.

Finally, we are in the midst of a scientific revolution in which the product of biological systems are being discovered to be unpredictable and invariably greater than the sum of their parts. Emergent phenomena arising out of vastly complex systems means that the balance sheets needed to make a consequentialist assessment of an act can never be closed nor the credits and debits ever intelligently summed. Perhaps then, like the earth's most ancient and successful organisms, we ought to have rules, or principles, as our guides rather than approaching every problem ad hoc. In that case, knowingly, or willfully ignorantly, imposing a significant risk on your fellow man that manifests might be such a rule for liability.

10th Circuit Sheds Light on "But For" Causation. Substantial Factor Causation, Not So Much

In Wilcox v. Homestake Mining Company plaintiffs argued that in toxic tort cases involving an injury with multiple potential causes "causation in such cases may be proven through a substantial factor test, without regard to whether the injuries would likely have occurred in the absence of the defendant's actions." Plaintiffs further argued that a "but for" causation requirement would make recovery all but impossible in toxic tort cases. The court rejected those arguments.

All a plaintiff has to do to get to a jury is to develop testimony that that the putative cause (e.g. radiation) was more likely than not a necessary cause of her injury (e.g. bladder cancer) and if there are multiple tortious sources of that cause then she can avail herself of alternate causation approaches (e.g. Summers v. Tice)  to assert liability against a specific defendant. On the other hand, it's not enough merely to show that the defendant brought plaintiff into contact with one of the known causes of her injury and it's not enough to show that the putative cause is one of the more common causes of that such injuries.

That's helpful. "But for" goes with the first legal causation question: was it more likely than not that the exposure (e.g. 5 fiber/cc yrs amphibole asbestos) was a necessary cause of plaintiff's cancer (e.g. mesothelioma). So where does "substantial factor" go? The court doesn't say. Like most courts it doesn't even say what it is.

Where should "substantial factor" go? We think it makes sense for it to go with the second legal causation question which is "was the exposure (i.e. the risk imposed) unreasonable?" The ability to estimate the ex ante risk of cancer imposed by exposure to a carcinogen allows both qualitative and quantitative assessments of the reasonableness of the defendant's conduct and informs the question of whether a particular exposure was substantial (and thus a basis for liability) or merely de minimis (and so unable to support a liability claim).

As we argued in Borg-Warner and have argued since, in a toxic tort case the ex ante risk imposed is the best measure of the reasonableness of the man (or woman). And that's what "substantial factor" causation ought to be about - determining whether there's some notion of responsibility associated with the particular risk imparted.

Parkinson's: Not Much Evidence for Manganese; Strong Evidence for Vitamin D Deficiency

In Tamraz v. Lincoln Electric Company, et al the 6th Circuit held that an expert could not stack speculation about mechanisms upon unseen and undetected lesions in the plaintiff to get from manganese exposure to his Parkinson's disease. Furthermore, the court ruled that you can't reasonably arrive at a causation opinion using what's erroneously called a differential diagnosis (it's more properly called simply a process of elimination) when you've no sound basis for ruling anything either in or out.

On the other hand, there's growing evidence that vitamin D deficiency is strongly associated with Parkinson's. Best of all, it makes sense. It looks like the enteric nervous system is first to be degraded in Parkinson's and that system is exquisitely sensitive to the gut mediated immune system which in turn is adversely affected by vitamin D deficiency. See: "Parkinson Disease: Could Sunlight Offer Protection from Parkinson Disease?"

The End of Toxic Tort Litigation in Texas?

If a plaintiff's cancer was caused by one molecule or one fiber damaging a single cell's DNA causing it to become malignant, and plaintiff was exposed to billions of molecules or fibers from multiple sources, how could he possibly prove that ,"but for" any single source of exposure or subset of exposures, he would not have developed his cancer? As stated, this is the Summers v. Tice problem traditionally resulting in burden shifting rather than dismissal so long as the conduct of each defendant was tortious.

Similarly, if plaintiff's cancer was caused by the cumulative effect of any one of several subsets of exposures from multiple sources, e.g. if three widgets were sufficient to cause cancer and plaintiff was exposed to one widget from each of A, B, C and D, she could never prove that "but for" A's widget she wouldn't have gotten cancer since the widgets of B, C and D were sufficient to have caused it; and the same would be true if she sued B, C or D. Again, the traditional answer to plaintiff's problem, assuming each defendant's conduct was tortious, has been to shift the burden of proof on causation. See Landers v. Texas Salt Water Disposal Co.

Suddenly the 5th Court of Appeals has in essence held that Borg-Warner v. Flores puts the burden of proof of causation back on plaintiff; doing so in a case in which the defendant stipulated so-called "general causation". See Georgia-Pacific v. Bostic. There's essentially no discussion of the rationale for imposing a "but for" causation proof burden on a toxic tort plaintiff nor is the impact of this monumental shift in Texas law even discussed so maybe the court didn't intend such a result. Indeed it did proceed to discuss substantial factor causation even after concluding that a "but for" burden was borne by a mesothelioma plaintiff with the result being that plaintiff's evidence was held insufficient to "provide quantitative evidence of [plaintiff's] exposure to asbestos fibers from [defendant's product] or to establish [plaintiff's] exposure was in amounts sufficient to increase his risk of developing mesothelioma."

So if you establish an increase in risk you've established substantial factor causation and that's the same as"but for" causation?! This case has a lot of lawyers scratching their heads.

It's time for a clearly articulated definition of "substantial factor" and it's time to get rid of the confusing and, in cancer cases, nonsensical "general causation" v. "specific causation" dichotomy. More on that after I get home.

Substantial Confusion

The Texas Supreme Court has just muddied the waters of its causation jurisprudence. For the last twenty years the court moved in a straight line towards a modern theory of legal causation. The court recognized the problem of causality; put fault back at the heart of torts - even in product liability cases; reaffirmed the counterfactual account of causation holding that plaintiffs must prove that "but for" the defendant's act or omission they'd be uninjured today; and, put reasonableness, and its best measure, the risk imposed, at the center of the calculus of how to define the limits of liability. Suddenly, everything (may have) changed.

In Transcontinental Insurance Company v. Crump, a worker's compensation case, the court held that a jury must not only be queried as to whether a putative cause was a "but for" cause, they must also be asked whether the alleged cause was a "substantial factor". As the court recognized years ago, in the context of causation in tort there's generally to be found the concept of substantiality "in which there always lurks the idea of responsibility.." Ok, but workers' comp is a no-fault scheme. What is "substantial factor" doing in a comp case then?

Maybe, just maybe, the court has come to think of "a substantial factor" as being a "big cause" - this is the idea that one or more necessary causes are somehow (despite them each being necessary) more significant than other (logically equal) necessary causes. They could have adopted something like a proximate cause concept (the idea of circumscribing those causes upon which liability may be predicated) but didn't - likely because the act itself uses the term "producing cause" long understood to mean a "but for" cause wherever it's found along the causal chain. As a result they may well have stripped "the idea of responsibility" from Texas' conception of "substantial factor".

If that's the case it's time for Texas' mass tort plaintiff lawyers to shake off the blues. A substantial factor test shorn of concern about responsibility means that Borg-Warner's test of reasonableness - risk, is now simply a test of whether or not the putative cause was a big one. And when it comes to, say, mesothelioma, what "bigger" cause is there than asbestos? There's now a good argument to be made that Judge Davidson's requirement that any putative cause be a sufficient cause in order to survive Borg-Warner sets the bar too high and that plaintiffs need only show that among all exposures adding up to .1 fiber/cc/yr the ones of which they complain are relatively "big". Good grief.

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Artful Pleading No Cure For Tort Reform

The Texas Supreme Court just withdrew its previous opinion in Marks v. St Luke's and substituted a new one - or rather several new ones. At issue was the question of whether an improperly assembled hospital bed that caused an injury was a premises defect or an integral part of the patient's care and treatment such that the claim necessarily falls under the Medical Liability and Insurance Improvement Act (MLIIA). The second opinion, a plurality, determined that the claim, however pled, is really a health care claim subject to tort reform.

What has caused all the consternation, as far as I can discern, is that the court previously held in Diversicare v. Rubio that premises liability claims that don't have something to do with the provision of health care may still be pursued against health care providers. The problem is that no one seems to be able to figure out what set of facts could constitute such a claim. If a bed is an inextricable part of the health care provided by a hospital what isn't? Apparently something in a hospital isn't inextricably tied to the provision of care as otherwise the simpler rule would be to say that since a hospital is built from the ground up with provision of medical services in mind then everything in it is subject to to the MLIIA.

Until something's found in a hospital that has no connection to health care it's best to plead your claim as a health care claim and timely file your expert report.

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Brief in Support of Industry Appeal May Change Debate on Private Right of Action For Climate Change Damages ... At least in the Courts

What has initially appeared to be a long litigation road to the answer of whether individuals have a private right of action to sue for climate change damages, may not be such a long road after all. Obama Admin Urges Supreme Court to Vacate Greenhouse Gas 'Nuisance' Ruling.  For some time, there appeared to be a 2-1 lead for advocates of a private right of action for climate change damages in light of the Second Circuit’s decision in AEP v. Connecticut and the Fifth Circuit decision in Comer v. Murphy to allow such claims against the Ninth Circuit district court decision in Native Village of Kivalina v. Exxon Mobil to dismiss such actions. But how quickly things can change. After granting a rehearing en banc, which automatically vacated the panel decision allowing the private right of action, the Fifth Circuit dismissed the district court appeal after it lost quorum due to a disqualified judge. Thus, only the AEP v. Connecticut Second Circuit decision remains in favor of a private right of action.

Yesterday, in a brief filed on behalf of the Tennessee Valley Authority, the acting United States Solicitor General agreed with the defendants in AEP v. Connecticut, stating that the U.S. EPA's newly finalized regulations on greenhouse gases have displaced that type of common-law claim.  This position clearly supports allowing the EPA, and the lawsuits against the EPA, to set the tone and pace of climate change regulation, but also brings the preemption, or displacement as some are calling it, versus tort claims debate experienced in other areas of mass torts to the environmental field. It is hoped that the Supreme Court will take up this issue once again sooner (as in this Fall) rather than later.

It is interesting to note that one of the administration’s recent Supreme Court appointee’s, Sonia Sotomayor, served on the panel but did not sign the decision issued by the Second Circuit in AEP. Interesting indeed.

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Causation and the Restatement (Third) of Torts: Part II

What does it mean, in the law of torts, for one to have caused another's injury? The standard legal account of causality has been that of the counterfactual put forward by David Hume as follows: "where, if the first object had not been, the second never had existed." (1748, Section VII). In the law it's the "but for" test and for our purposes then the courts tend to attach legal liability (assuming the existence of a duty and its breach) only upon the following: had Defendant done otherwise, Plaintiff would today be uninjured. 

Generally speaking the "but for" test is easy to use and produces a nice clean binary answer of the sort favored by courts trying to resolve disputes. (e.g.  "But for" Defendant having run the red light Plaintiff would have passed through the intersection without incident and would not have suffered the broken leg of which she complains.) Of course there are innumerable "but for" causes of the accident, including the Defendant's mother having given birth to him and the rudeness of the fellow with a cart full of groceries in the "10 items or less" line who slowed Plaintiff down so that she wound up in the intersection at the same moment as Defendant. Nevertheless, and almost invariably without much analysis, the parties settle on just one among the countless posibilities as the sine qua non act (or omission) to be subjected to the "but for" test.

However, when deployed in a case in which plaintiff's injury was caused by only one of several identical and indistinguishable acts (see e.g.  Summers v. Tice) or by the cumulative effect of some subset of several identical and indistinguishable acts (see e.g. Landers v. East Texas Salt Water Disposal Co.) the "but for" test would, without some other rule, produce the jarring judgment that none of the defendants, considered individually, were more likely than not the sine qua non cause of the plaintiff's injury. In those cases, finding that the acts (divorced from the inquiry of whether they were actually causative) were tortious, the courts held that the defendants should bear the burden of proof that theirs was not the act that caused the plaintiff's injury. The instances in which such a rule would apply were surely few and even a century ago the idea of treating the defendants collectively and shifting the burden on to them was not unheard of. See 2 J. Wigmore, Select Cases on the Law of Torts Section 153, p. 865 (1912) ("When two or more persons by their acts are possibly the sole cause of a harm, or when two or more acts of the same person are possibly the sole cause, and the plaintiff has introduced evidence that one of the two persons, or one of the same person's two acts, is culpable, then the defendant has the burden of proving that the other person, or his other act, was the sole cause of the harm.")

An effort to distill all judicial reasoning about causation down to its essence and to make a rule of it has been underway for some time. Probably the most cited rule, a form of which is incorporated into the Restatement (Third) of Torts, is the NESS test. NESS stands for "necessary element of a sufficient set". The NESS test is itself a restatement of an older test in which a singular putative cause is said to indeed be causative if it, though insufficient, is nevertheless a necessary element of a precipitating event which event, though perhaps itself unnecessary, would nevertheless have been sufficient to have produced the outcome under investigation (see "Causes and Conditions" by J.L. Mackie). What in the world does any of that mean? In Mackie's example investigators of a fire are satisfied that a short-circuit was the cause of a house fire when conditions were such that the short circuit existed, flammable rags were nearby and those rags once ignited were sufficient to cause a conflagration that would burn down the house. The short-circuit alone was insufficient to burn down the house but it was necessary (other causes having been ruled out) to catch nearby flammable rags on fire. Lots of things can ignite and so burn down a house (so burning rags are not necessary to have a burning house) but burning rags are sufficient to torch the place. Whew.

"But for", causal analysis seems then to be about ruling things out and settling on what's left (the short-circuit). On the other hand, the investigation of the product of the remaining thing(s) (sufficient set) seems aimed towards the propensity of one condition (burning rags) to lead to another (burning house). It is out of this second analysis, of the propensity for one thing to lead to another, that queries about reasonableness and foreseeability and risk arise. More on that later though when I get to risk.

Anyway, the reductionist effort itself precipitated a debate about whether the NESS test accounts for all judicial causal reasoning that continues to this day. Take for instance the hypothetical case of the desert traveler. The desert traveler set off to hike across the desert with just enough water to make it to the other side. Unbeknownst to the desert traveler, defendant "A" had poisoned his water such once that he'd consumed all of it he would surely die. Along his way across the desert however, defendant "B" stole the desert traveler's water bottle. The desert traveler was found dead in the desert. If defendant "A's" conduct was not the cause of his death, why not?

Such conundrums would normally make for nothing more than an obscure niche in the law in which a few academics could regularly generate tedious and unread papers. Then forty one years ago Clarence Borel, dying of mesothelioma, filed a products liability claim in Beaumont, TX culminating in an opinion that would usher in the age of mass torts. Concluding that as it was impossible "to determine with absolute certainty which particular exposure to asbestos dust resulted in injury" and because "each exposure may result in an additional and separate injury" the 5th Circuit held in Borel v. Fibreboard that a jury could reasonably conclude "that each defendant was the cause in fact" of Borel's injury.

Twenty seven years after Johns Manville sank under the wave of litigation unleashed by Borel the practical effect of the ruling continues to drive companies into bankruptcy. The Restatement (Third) of Torts was awkwardly silent on the issue of "the mother of all mass torts" but recent musings by its Reporters and others suggest that they thought rather a lot about it and that its impact on the restatement effort was in fact profound. The shame of it is that they almost got it exactly right. All that was needed was to distinguish between risk and causation and to embrace Palsgraf's true meaning: that the risk imparted is the measure of the reasonableness of the man.

Next time: Risk.

Arrogant, Overconfident or Just Like Everybody Else?

Overcoming Bias and Barking Up The Wrong Tree are both commenting about the recent article "Insightful or Wishful: Lawyers' Ability to Predict Case Outcomes". Four hundred eighty one lawyers were queried about their expectations for one of their cases set for trial. After all was said and done the actual outcomes were compared to the trial lawyers' ex ante predictions and they didn't too to well; not even the ones who'd been out for years. So what gives?

Do lawyers overpromise in order to attract business, as Robin Hanson suspects? I'm sure that's sometimes the case. I once had a front row seat, as it were, that afforded me the opportunity to witness (and my client, formerly the target defendant, to benefit from) another firm's Senior Trial Partner's  first jury trial (and believe me his client had to push him to the courthouse kicking and screaming). He was played like a fiddle by the plaintiffs' attorney and by the time he read his closing from across the room he looked like a cornered animal. The verdict was huge.

Yet I don't think overpromising by underperforming trial lawyers accounts for most of the poor predictions. Rather, they likely fell prey to all too common faulty heuristics. They've spent weeks building a narrative that fits the facts and the law and the story ends happily ever after for their clients. And the bad guys' story? They've spent as much time or more poking holes in it so that for every doubt imagined a counterpoint leaps effortlessly from memory. Why isn't this just the usual sort of programmed reasoning exercise that makes most people poor prognosticators?

Finally, how are cases resolved? If settled isn't it usually on terms that nobody's especially thrilled about? And if they're not settled the distribution of outcomes, at least in my experience, tends to be U-shaped with a bunch of $0 verdicts on the left and a bunch of "ring the bell" verdicts on the right and not too many "kiss your sister" verdicts in between. I had a young lawyer recently tell me what he estimated the expected value of his case ought to be. The problem, of course, is that once the bell rings twice (or whatever jurors do in your jurisdiction to signal they've got a verdict) you're about to be, like the owner of Schrodinger's cat, either really really happy or really really sad. When the possible is collapsing into the certain why should it be a surprise that lawyers usually get it wrong when the odds of getting it right are against them?

Empirical Legal Silliness

Running sophisticated statistics software over a pile of data drawn from the opinions of an appellate court does not guarantee a sophisticated analysis of the court's decision-making. In fact, given what I've read in a couple of fairly recent law review articles, about the only thing it guarantees are unwarranted conclusions and no analysis whatsoever.

I had high hopes for the testing of hypotheses about legal reasoning. Take for example the work of Jeffrey Rachlinski. He was able to demonstrate that judges have some of the same cognitive blind spots as the rest of us; the most notable of which being hindsight bias. (See e.g. "Inside The Judicial Mind"). But this new fad of indiscriminately dredging for correlations and publishing uncritically the inferences generated thereby is very troublesome.

Let's take a suggestion from one law review article that a certain court is biased because the win/loss ratio for plaintiffs and defendants deviates significantly from what would be expected of an unbiased court. Specifically, that the defense prevailed in more than 68% of the cases tallied implying to the author that something significant was afoot since the observed distribution was more than one standard deviation beyond the expected. Upon what premise must such a conclusion rest? Either that justice is or ought to be decided by casting lots (in other words that the distribution of wins and losses should look like the results of flipping a coin a large number of times and so appear as a Gaussian distribution) or that cases appear randomly before the court. The former denies the existence of justice as we know it and the latter denies the facts - plaintiffs often press novel claims, seek to overturn or plead around statutes (like tort reform) or try to hold on to huge verdicts - all of which might reasonably be expected to influence the likelihood of success on appeal. Nevertheless, none of these assumptions or possible biases and confounders are discussed anywhere in the paper.

Another recent article demonstrates the misuse and abuse of statistics. In it the author claimed to have uncovered a power law behind certain judicial decision-making. Finding a hidden power law is considered very sexy these days. They're different than merely normal distributions; they explain an increasing number of natural phenomena (e.g. most prominently some economic  conditions in the current troubles - see: Pareto distribution); and, best of all, they allow you to torture your data with even more impressive-sounding statistical tools.

The problem however is that putting fancy tools in the hands of someone who doesn't know how to use them cannot lead to anything worthwhile. And so it was with the second paper that had me despairing. On a log-log plot a power law will reveal its distribution as a straight line. But while a straight line on a log-log plot may be necessary for the presence of a power law it's not sufficient; yet that's stated no where in the paper. But that's a minor quibble compared to the real problem with the analysis. Rather than plotting the data on a scatter graph and inferring that a power law might lie beneath, the author apparently put the data on a log-log plot, forgot it was a log-log plot and ran a linear regression on it thereby forcing a nice straight line where there was none - the result being a sort of tautology-by-statistics. 

Don't get me wrong. The discovery that certain behaviors could be explained and predicted mathematically would be a big deal. But when you see a vigorous debate in the scientific literature about whether bacterial foraging behavior (swim straight vs. tumble and then swim somewhere else) should be described by a power law curve rather than Gaussian bell curve it makes you wonder whether something as complicated as the administration of justice can ever be reduced to a simple formula. Human scale biological systems are fantastically complex and I'd expect that the approach a judge takes to her task of doing justice, the application of principles - our way of dealing with complexity and uncertainty, would be even moreso.

 

"You Got Your Science In My Activism!" "You Got Your Activism In My Science!"

Yuck! Tastes like CBPR.

CBPR? I hadn't heard of it either; not until this week anyway. It's "community-based participatory research" and the idea is to get activists and scientists together to do research into things like the cause of higher than average breast cancer rates in some high net worth communities. The activists want the scientists to prove that pesticides are causing breast cancer in their communities; and so the scientists promptly set out to falsify the activists' claims. Why wouldn't it turn out well?

The answer can be found in "A Review of Advocate/Scientist Collaboration in Federal Environmental Breast Cancer Research". It turns out that "effective" CBPR requires a different sort of "inquiry paradigm." You see "[t]he positivist paradigm remains dominant in much scientific research, emphasizing objective knowledge that is separate from the knower and can only be uncovered through a scientific method of inquiry that is neutral and bias-free." "CBPR challenges this paradigm by contextualizing scientific research within particular communities, including and legitimizing advocates' knowledge, understandings, and priorities regarding issues by which they are personally affected." (Ibid at pg 17).

So researchers, schooled in the long history of how biases, prejudices and failures to challenge closely held beliefs have thwarted science and medicine in the past, are to drop everything they hold dear? Or is it that advocates are to drop their beliefs, acquiesce to all the money they lobbied for being spent on an effort to falsify those beliefs; and, after seeing them falsified, to say "Nevermind", take the hit to their reputations and set about constructing a new narrative for their lives? The former rejects the scientific method; the latter, human nature. 

FDA Panel Votes to Keep Avandia Available for Type II Diabetes Patients

Despite a steady drip drip drip of out-of-context memos, disconnected snippets of depositions and dire predictions that rose to a torrent last night, the FDA's panel of experts today voted 20 - 13 to keep Avandia on the market, though, most suggested, with more warnings. More significantly, despite vicious ad hominem attacks on respected academics and physicians, the panel also voted to complete the TIDE study - one of those "gold standard" studies that should in 2015 produce at last some definitive data on the questions of whether Avandia poses an unacceptable risk for diabetics and whether it produces a better outcome than a competitor.

Of all the objectives of those who lead such attacks their effort to declare science settled and to outlaw further experiments that might falsify their claims is the most frightening. On the other hand, when you consider what happened with the breast implant litigation you have to understand that by waiting for the truth those who fed The New York Times stray documents and quotes from discovery would only put their businesses at risk. Fama, malum qua non aliud velocius alium.

 

Avandia: Burn Her Anyway?

Three years ago Dr. Steven Nissen published "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes" in which he reported that those taking Rosiglitazone (Avandia) had about a 40% increased risk of acute myocardial infarction (heart attack). The study was a meta-analysis of published and unpublished data and drew extensively from the manufacturer's unpublished data.

The media simultaneously reported the findings and propagated the following narrative: The pharmaceutical companies collect vast quantities of data; publish only what supports their products; and are at best willfully ignorant of the risks of their products which risks are right before their eyes if only they would look. Dr. Nissen who "has a statistician’s zeal for drilling deep into clinical data, seeking signs that some widely used drugs pose undisclosed risks to patients" was made the hero of the drama. Congress got involved by beating the drums of safety and transparency and demanding that the FDA pay more attention to ensuring that pharmaceuticals are safe.

The FDA reassessed Avandia and panel members voted 21-3 to keep it on the market.

In February of this year, a Congressional investigation conferred near-martyr status on Dr. Nissen after it was revealed that he had secretly tape recorded a meeting with the representatives of the maker of Avandia. The same month, in European Heart Journal, he published the editorial "The Rise and Fall of Rosiglitazone". Meanwhile everyone was waiting for the results of a huge study of Avandia.

Last week that study, "Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated with Rosiglitazone or Pioglitazone" (interestingly, for several days JAMA made you click through an ad for a competitor's type 2 diabetes product to get to the article) was published. And what was the risk of heart attack among those elderly patients on Avandia? Essentially no different than those on the older medication - a statistically insignificant 1.06 increase - especially so given the fact that almost three quarters of all type 2 diabetics wind up dying of heart disease in any event. So, was Avandia cleared? Nope. In fact, the calls for removing it from the market have grown even louder.

The new study, while rejecting the original claim that Avandia causes heart attacks, raised the hypotheses that Avandia causes congestive heart failure and stroke and increases the rate of mortality overall. Yet even though the numbers of patients involved in the study (their records were simply culled from Medicare databases) was large (227,000) the increases were relatively small and by the time the increases appeared (after six to fifteen months of medication) only a small and rapidly decreasing fraction of the original cohort were actually still on one of the two medications.

At almost the same time Dr. Nissen published an updated meta-analysis ("Rosiglitazone Revisited: An Updated Meta-Analysis of Risk for Myocardial Infarction and Cardiovascular Mortality"  also free and also, though published in the Archives of Internal Medicine, only after an ad for the same competitor's type 2 diabetes product) that purports to show that Avandia increases the risk of heart attack but doesn't increase the risk of mortality. What? Hey, wait a second! How can ... So, siding with those advocating "safety over certainty" the New York Times quickly editorialized in favor of those demanding Avandia be removed from the market.

The LATimes went so far as to publish a piece calling for "an immediate moratorium on sales as soon as a credible study raises questions about safety." In that same piece the journalist was posed the following question by a researcher being interviewed: "Suppose a drug saves five people and kills one person. Do you keep it on the market?" His answer was "I know this: If that one person killed is my loved one - or yours - the answer is readily apparent."

Yikes. Really? If a data dredge shows any risk of a fatal outcome then the drug should be pulled from the market no matter how many people are killed in the process? We'll save for another day the question of how thinking about risk goes so badly astray. For now though consider how likely it is (yes likely - and in fact, if the number of endpoints examined are sufficiently large, how almost certain it is) that a risk will be found where none exists. Start with "Data Dredging, Bias, or Confounding: They Can All Get You Into the BMJ and the Friday Papers" and then for more on the perils of statistical deep drilling read "Your Intuitions Are Not Magic" and the links therein.

At the end of the day the issue isn't safety versus certainty. Claiming that pharmaceutical manufacturers are insisting upon certainty before warnings are issued or products are pulled is just a straw man argument. The usefulness of statistical analyses of medical outcomes has not been added to "death and taxes".The real question is which course is less uncertain - making vital judgments on the basis of large randomized controlled trials like the one due out on Avandia in 2015 or on the basis of data dredges? The answer ought to be obvious.

Texas Supreme Court Delivers Some Good News to Texas Trial Lawyers

The Texas Supreme Court has just decided an appeal we discussed last year in "Dyspepsia Time for Texas Trial Lawyers?" The court in Thomas O. Bennett, Jr. and James B. Bonham Corporation v. Randy Reynolds upheld punitive damages against the individual as well as against the corporate defendant holding that when a vice principal uses corporate authority over corporate employees on corporate land to commit a tort with corporate equipment it makes the corporation liable for punitive as well as actual damages. The court did, however, remand the case to the court of appeals for remittitur with instructions that it limit punitives to within, and likely somewhat below given that the wrong did not involve death or severe bodily harm, the "absolute constitutional limit [of 4:1 ]" (citing Gullo Motors).

Those doing asbestos litigation are likely to hear a lot about the court's "reprehensibility analysis" that led it to conclude that punitive damages were warranted - specifically this sentence: "We have previously held that certain cover-up efforts can show reprehensibility, as when a manufacturer of asbestos-containing products continues selling what it knows is dangerous."

The opinion concluded this quintessentially Texas case as follows: "We agree with the court of appeals that 'Texans know better than to steal cattle, an offense once redressed beneath a tree rather than inside a courtroom. That said, the 47:1 and 188:1 ratios here exceed the outermost limit permitted by due process. We thus remand to the court of appeals to reconsider exemplary damages in line with this opinion and prevailing ratio analysis.'"

Analysis of Bennett v. Reynolds

Continue Reading...
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EPA Reanalyzing Dioxin Toxicity

On June 14, USEPA gave notice of a July 9, 2010 "listening session" related to its external review draft document entitled "EPA's Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments." The draft document includes new analyses on potential human effects from exposure to 2, 3, 7, 8 tetrachlorodibenzo-p-dioxin (TCDD). The draft document was also provided to EPA's Science Advisory Board for peer review.

BP To Establish $20 Billion Fund For Spill Claims

The LATimes is reporting that a 9-11 style fund will be established by BP and administered by Kenneth Feinberg to compensate those suffering losses as a result of the Macondo well spill.

Mass tort litigation may never be the same. Plaintiff firm business models will need to change to accommodate these "BOOM! Done" resolutions of mass claims. In the past the folks who got rich were those who commanded "magic" venues and those who could try cases. Now it looks like those who can round up the most plaintiffs stand to make the most. It makes you wonder how much Google will be getting for pay-per-click ads generated by the words "oil spill."

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No Take Home Asbestos Liability For Premises Owners In Ohio

“He whose stuff it is must keep it that it may not trespass.” So said Sir John Holt, Lord Chief Justice of England and Wales, in the case of Tenant v. Goldwin in 1704. (1704) 2 Lord Raymond’s Reports (Ld Raym) 1089, 1 Salkeld’s King’s Bench Report 21, 360. Chief Justice Holt was addressing the escape of “filth” from one property into another, and the cause of action for the damages caused by the “filth.” There is some dispute whether the cause of action sounded in trespass (Salkeld) or in private nuisance (Raymond). However, most scholars agree that the modern concept of strict liability traces its origins to Chief Justice Holt’s decision.

Yesterday, the Supreme Court of Ohio in effect resoundingly rejected the principal in Tenant v. Goldwin. In a 5-1 decision, the Court in Boley v. Goodyear Tire and Rubber Co. upheld and applied ORC 2307.941(A)(1), a “tort reform” provision enacted by the General Assembly in 2005. The court found that the statute bars tort claims based on “take home” exposure from a workplace where the exposure takes place away from the property owner’s premises. The statute does not address liability of products liability defendants for take home exposures. In her concurring opinion, Justice O’Connor noted that a different provision in the 2005 asbestos litigation reform bill, R.C. 2307.92(D)(2), provides a legal basis for asserting wrongful death claims against defendants other than the premises owner for take-home exposure of family members to occupational asbestos. The Supreme Court of Ohio’s announcement of the decision, written opinion, and a video of the oral argument before the Court can all be found here.

Sadly, it does not appear that the Court or the parties in Boley were concerned with the effect of the statute on Chief Justice Holt’s tort law legacy.

Navy's Fault Must be Assessed in California Asbestos Suits

In Collins v. Plant Insulation, a California appeals court has determined that under California law, a jury must determine the Navy’s fault in an asbestos wrongful death suit in order to determine the defendant’s percentage of fault. This holds even though the Navy is immune from suit and the plaintiff cannot recover from it.

Under California’s Proposition 51, the jury must determine each defendant’s responsibility in direct proportion to that defendant’s percentage of fault. The Court held that it was impossible for the jury to determine the defendants’ proportion of fault without considering the fault of the Navy, the premises where the plaintiff worked for a number of years.

This brings California law in line with that of Texas, where the jury must determine the fault of all potentially responsible parties, whether or not they are solvent or before the court. This is designed to keep those with deep pockets and small liability percentages from paying the whole of Plaintiff’s damages.

Duty Exists For Take-Home Exposure - Texas Asbestos MDL

Judge Mark Davidson, who presides over the Texas asbestos MDL denied summary judgment on the issue of whether a duty exists for take-home exposure to the spouse of a defendant’s employee. In Carrie Ramsey v. Borg Warner Morse Tec. Inc., et al, he issued a letter ruling in which he determined that DuPont owed a duty to the spouse of one of its workers who developed mesothelioma.

The plaintiff’s ex-husband had worked at a DuPont facility from 1964 to 1974. He worked as an operator and later as a supervisor who patrolled the plant, and worked in various areas during startups and shutdowns as needed. He did not work hands-on with any asbestos products but worked around those who did. Plaintiff laundered, on a daily basis, the clothes her ex-husband wore home his from DuPont. Before she placed his clothes in the washing machine she would shake the dust off his clothes, which she breathed. She was diagnosed with pleural mesothelioma in 2008.

According to Judge Davidson’s ruling, documents produced by DuPont indicated that DuPont knew of the dangers of asbestos by the early 1960s. DuPont knew of a link between small exposures to asbestos and cancer by June 2, 1966. A 1964 DuPont document authored by the director of DuPont's Haskell Laboratory for Toxicology and Industrial Medicine stated that cases of mesothelioma could be caused by "exposure to dust brought home by relatives working with asbestos.” This report also identified three types of exposures to asbestos that are recognized as leading to an increase of mesothelioma: 1) factory workers manufacturing asbestos textiles; 2) insulating materials; and 3) “exposure to dust brought home by relatives working with asbestos.”

A DuPont document dated May 21, 1968 detailed DuPont’s knowledge of asbestos dangers and that “Wives and children of asbestos workers are also being involved because of the dust laden clothes a man wears home at night.”

In his ruling, Judge Davidson stated that the evidence in this case went far beyond that in Behringer v. Alcoa in which the Dallas Court of Appeals held Alcoa owed no duty to an employee’s spouse who developed mesothelioma. Davidson stated the following:

“If this isn’t enough evidence to comply with Behringer, I really can’t imagine what is. Mr. Ramsey’s exposure continued for six years following the time interval DuPont documents show they were aware of the dangers to its employees’ families. The Behringer case held that the [sic] Alcoa had no knowledge of the dangers of household exposure in the 1950s, and that no duty existed in the absence of that knowledge. In this case, there is some evidence that the Defendant knew as early as 1964 and certainly by 1968. Exposure continued until 1974."

OSHA Director Claims Regulations For Workplace Exposure to Infectious Agents Are Inadequate

The title is taken from a quote in a New York Times piece headlined: Safety Rules Can't Keep Up With Biotech Industry. The article details several accidents resulting in serious injury or death plus an alleged whistleblower's $1.4 million recovery. David Michaels, author of "Doubt is Their Product: How Industry's Assault on Science Threatens Your Health", and now Director of OSHA, is also quoted as saying "[w]orker safety cannot be sacrificed on the altar of innovation."

A new Rachel Carson and a new Erin Brockovich have already been proclaimed; now it seems there's also a new Karen Silkwood and a new Eula Bingham. The casting is complete. If this production has a run like the last one mass tort lawyers will be busy for years to come.

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An Unusual Benzene/MDS Opinion

In Quillen v. Safety-Kleen Systems, Inc., 2010 WL 2044508 (E.D.Ky.) the court determined that plaintiff's expert, Dr. George Rogers, could properly attribute a case of myelodysplastic syndrome (MDS) to benzene by doing a differential diagnosis. That some courts have taken to using differential diagnosis to identify the root cause of say splenomegaly rather than to distinguish histoplasmosis induced splenomegaly from Hodgkin's disease induced splenomegaly would likely set many physicians' eyes rolling.  Yet, that's apparently what the 6th Circuit said in Hardyman v. Norfolk & Western Railway Co., 243 F.3d255 (6th Cir. 2001) and thus the thinking by the Quillen court.

The point of doing a differential diagnosis, of course, is to rule out possible causes until just one is left - it's a process of elimination. But just because every other cause of splenomegaly has been ruled out in the case of a male patient that doesn't mean that it makes sense to conclude that the cause must be the remaining possibility - a metastatic ovarian cancer. To be considered for elimination in the first place the putative cause has to be one that makes sense. In Quillen though there was no effort to demonstrate that plaintiff's experience with benzene was the sort that would make benzene a reasonably plausible cause of his MDS.

Finally, please ponder the following. In response to the defendant's objection that plaintiff's expert had not ruled out ionizing radiation  the court wrote: "Defendant points to nothing in the record demonstrating that Quillen was ever exposed to a statistically significant amount of such radiation." Somewhere an epidemiologist just fell out of her chair.

Final Nail In the Vaccine/Autism Coffin?

The Court of Appeals for the Federal Circuit recently drove what we hope is the last nail in the coffin of the vaccine/autism litigation. Rarely has a toxic tort had the potential to cause so much harm based on such shoddy science. The history of this tort and its shortcomings have been reported in great detail.

In short, the scientific evidence that vaccines cause autism came from a discredited article by Andrew J. Wakefield and two follow-up articles. Dr. Wakefield’s article created a public health crisis with parents, including celebrity parents Jenny McCarthy and Jim Carey, urging parents not to get their children vaccinated. As a result, formerly endemic childhood diseases which had become effectively eradicated in the developed world began to make a reemergence. Wakefield’s article was finally withdrawn from the Lancet earlier this year after 10 of the 12 co-authors disavowed it. Wakefield, himself, refuses to withdraw the article even though it was found that he committed scientific misconduct and lied in the article. The UK’s General Medical counsel’s Fitness to Practice Panel issued a judgment against him for his vaccine/autism paper. Wakefield continues to testify. Others testify based on his work.

Thankfully, the vaccine litigation was consolidated in the federal Vaccine Court pursuant to The Vaccine Act (passed in response to the health scare where the DTP vaccine was accused of causing neurological damage and in response to lawsuits, stopped being manufactured). Plaintiffs in three bellwether cases all failed on causation. The Special Masters wrote massive opinions eviscerating Wakefield and the causation theories of Plaintiffs.

Hopefully parents can now rest assured that vaccines are not a risk for autism. And, they can recognize the far greater risks to their children and society from not vaccinating.

EPA Greenhouse Gas Permitting: Final Rule

The EPA has just announced its final rule for greenhouse gas emissions from large fixed sources such as power plants and refineries. Starting in January of next year large facilities already required to obtain Clean Air Act permits for other emissions will have to seek a greenhouse gas permit if such admissions increase by 75,000 tons/yr or more. Six months later the requirements will expand to cover all new facilities with emissions of at least 100,000 tons/yr and older installations with modifications that result in increases of 75,000 tons/yr or more. The rule covers not only CO2 but also methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons and sulfur hexafluoride. It's anticipated that the rules will be expanded to additional sources effective July 2013.

The EPA believes that these new standards will avoid overwhelming permitting burdens that otherwise would have fallen on the government and most sources of greenhouse gas. The EPA notes that without this rule the permitting and "best available control technology" burdens would fall on operations with emissions as low as 100 tons/yr producing "an absurd result" - not to mention an immense political backlash propelled by an impossible to administer regulatory scheme. Instead, conceding in essence the slippery slope objection, expansion of the regulations to smaller emitters will proceed "one-step-at-a-time". Had the rules become effective for all emitters at once an estimated 6 million U.S. farms and businesses would have suddenly become subject to the permitting process with the time from application to permit approval lengthening to a decade or more.

The CliffsNotes version is here: Fact Sheet and here's the Final Rule

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Vapor Intrusion Rises in Importance in 2010

Eight years after issuing “draft” guidance on vapor intrusion, the EPA will issue an “interim” guidance this year that is supposed to move the organization closer to issuing a final guidance in 2012. This sudden rise in importance was prompted by an evaluation that the lack of final guidance on vapor intrusion by the organization impedes efforts to assess indoor air risks. Since 2002, more than half the states and other governmental bodies have issued their own vapor intrusion standards, leading to ad hoc and inconsistent standards across the board. So why not finalize the draft? Well, the times have changed and so has the EPA’s approach. This new risk based approach no longer supports some of the assumptions inherent in the draft guidance. For instance, the EPA will use updated toxicity values, beginning with trichloroethylene (TCE) and tetrachloroethylene (PCE) toxicity values, to determine at what level an indoor risk exists, and consider more significantly atmospheric and building specific effects. But, alas, there are many more than assessment questions to be answered in the final guidance. Again, not waiting for the answers, ASTM International announced last week that it will soon release its ASTM E 2600 Guide: Vapor Encroachment Screening standard for conducting due diligence for sale of properties where potential vapor intrusion is a concern, a revision of its 2008 standard that was criticized for being overbroad. The ASTM standard will focus on identifying potential sources in the surrounding areas of the real estate property rather than broad assessment of an existing vapor intrusion problem. Years after the 2002 guidance, many thought the final guidance would be immediately forthcoming, but it was not. While more certainty is definitely desired by all parties involved on this issue, what we hope is that the “interim” guidance does not dance to the same tune as the “draft” guidance…one step forward and two steps back!

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$200M Punitive Damages Award in Take-Home Exposure Mesothelioma Trial

Yesterday a Los Angeles jury awarded $8.8M in compensatory damages and $200M in punitive damages in a take-home exposure case against CertainTeed and the Los Angeles Department of Water & Power (Evans v. A.W. Chesterton, et al). Plaintiff Rhonda Evans claimed that she contracted mesothelioma as a result of exposure to asbestos fibers that had been carried home on her husband’s clothing who cut asbestos pipes manufactured by CertainTeed for the Los Angeles Department of Water & Power.

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US Supreme Court Limits Class-Action Arbitrations

In Stolt-Neilsen S.A. v. Animalfeeds Int’l Corp., the US Supreme Court held that an arbitration panel may not determine that a class-action arbitration is allowable in the absence of an express provision in that arbitration clause.

The case stems from the global shipping price fixing practices uncovered by the US Department of Justice in 2003. Animalfeeds International ships raw ingredients to animal feed producers around the world. The standard shipping contract in issue, called the Vegoilvoy charter part, first adopted in 1950, has an arbitration clause which is silent as to class actions. And, no class action has ever been conducted based on the particular charter party arbitration provision.

Nonetheless, Animalfeeds sought class action arbitration in New York on behalf of all global shippers affected by the alleged price fixing. An arbitration panel was set up to determine in the first instance whether class-action arbitration was proper in this case. Relying on a public policy interpretation, the arbitration panel determined that it was.

The Supreme Court determined that in the absence of an arbitration provision allowing class action status or a state substantive law in the relevant jurisdiction allowing class action arbitration in the absence of express consent, the arbitration panel’s decision to allow the class-action arbitration exceeded its powers. Parties cannot be put into class-action arbitration unless they agree to it. And, arbitrators have no power to determine cases based on public policy.

This decision fits within recent Supreme Court jurisprudence on arbitrations. Recently, the Court decided that parties who contracted for arbitration could not also contract for judicial review. See Hall Street Assoc, LLC v. Mattel, 522 US 576, 128 S.Ct. 1396 (2008). In Hall Street, the Supreme Court’s decision seemed to say, “if you want arbitration, yet get arbitration. Don’t come complaining to us about the arbitrator.” In this case, the Court seemed to temper that somewhat.

In this case, the parties agreed to arbitration between them. The shipper did not agree to have Animalfeeds as the class representative of all its customers in one mass action against it. Such a class-action arbitration would bind parties who were not part of the arbitration agreement and likely reduce many of the benefits normally accorded to arbitration over litigation (cost vs. speed, finality vs. ability to appeal, etc.).

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Court Forces Production of Settlement Agreements in Benzene Case

Yesterday, the 9th Court of Appeals in Beaumont, Texas conditionally granted mandamus relief in Thompson v. Univar; a benzene/leukemia case. In the trial court Univar had moved to compel the production of settlement agreements. Discovery of such settlement agreements are seemingly expressly called for by Texas’ Rule of Civil Procedure 192.3(g). Nevertheless, some courts routinely refuse to compel their disclosure and that’s what happened here.

Plaintiffs had objected to the disclosure of the settlement agreements stating that they were subject to confidentiality clauses. Plaintiffs did agree to disclose, in aggregate, the total amount of money agreed to be paid by the settling defendants. Without reviewing the agreements the trial court accepted plaintiff’s representation and denied Univar’s motion to compel.

The appeal drew several amicus briefs, including some from former parties which had settled with plaintiffs, that argued against disclosure of settlement agreements.

Holding a plain reading of our discovery rules demonstrates that such agreements are discoverable; that they are additionally discoverable so as to uncover any potential bias on the part of any witness (e.g. agreements to cooperate or not cooperate); and that they ought to be timely discovered, the court of appeals ordered that the agreements be disclosed by the end of the week.

Trial begins Monday in Beaumont.

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EPA to Address High Risk Chemicals

The long-awaited proposed revisions to TSCA were introduced in the U.S. House and Senate last week. As expected, these proposals, referred to as the “Safe Chemicals Act of 2010” in the Senate and as the “Toxic Chemicals Safety Act of 2010” in the House, contain numerous similarities to REACH. For example, the precautionary principle will apply, manufacturers will need to submit data on each chemical produced and its use, the EPA will be required to prioritize chemicals based on risk, the EPA will be expected to address high risk chemicals quickly. Chemical information submitted will be publically available, the scope of confidential business information will be significantly narrowed, and there is a focus on using safer alternatives to chemicals of concern.

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Bodie Pryor Dies at Age 96

Mr. Pryor played an indispensable role in starting up the chemical tort litigation that began (like everything else, seemingly) in Beaumont, TX. Read all about it in "Catching a Killer" and in "The Cancer Belt". In particular it was the butadiene litigation for which he'll be remembered by toxic tort lawyers. You can find his obituary in the Beaumont Enterprise.

 

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Long-Arm Statute Doesn't Reach Transporter of Goods Through Texas

The Texas Supreme Court recently concluded that merely transporting goods through Texas does not create sufficient minimum contacts to establish specific jurisdiction in this state. In the case of Zinc Nacional, S.A. v. Bouché Trucking, Inc., a Mexican company (Zinc) sold paper to a company in New Mexico. Zinc transported the product to the Texas border, transferred the trailer to another truck company (Bouché), which transported the paper through Texas to New Mexico. Zinc does not have an office, agents or employees in Texas and does not sell paper to Texas manufacturers. During one particular shipment in 1999, the Bouché driver was injured when the contents of the trailer shifted and the truck overturned. The driver filed a negligence suit against Bouché.

Bouché sought third-party indemnification and contribution through Zinc, who filed a special appearance to challenge specific and general jurisdiction. The trial court denied Zinc’s special appearance. The Court of Appeals upheld the trial court’s opinion stating that “Zinc had purposefully availed itself to Texas benefits” and “had thereby established sufficient minimum contact for purposes of specific jurisdiction.” The Supreme Court disagreed finding that Zinc doesn’t have the minimum contacts necessary to establish specific jurisdiction, concluding that third-party shipment of goods through Texas “does not, by itself, constitute purposeful availment.” The Court reversed and remanded the case to the appellate court for determination of the general jurisdiction issue.

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Texas Premises Liability: A Warning May Not Be Enough

 

The Texas Supreme Court recently delivered its opinion in Del Lago v. Smith, 53 Tex. Sup. Ct. J. 514 (2010). Smith was a patron of the Grandstand Bar which is part of the Del Lago resort on Lake Conroe, Texas. He was a member of a fraternity reunion that got into a brawl with a wedding party. The brawl erupted after ninety minutes of drunken threats between the two groups. The bar employees witnessed the hostility, did not call security or the police, did not throw anyone out, but did keep pouring drinks. Smith witnessed all of it but did not leave. When the fight started, Smith joined the fray and was eventually run into a wall by another man and his skull was fractured. Once the fight started, the bartender called security, who arrived within three minutes and broke up the fight. The jury found the bar 51% liable and Smith 49% liable and awarded almost a million and a half dollars in damages.

The most significant holding of the case can be found in this paragraph:

"We hold that Del Lago had a duty to protect Smith because Del Lago had actual and direct knowledge that a violent brawl was imminent between drunk, belligerent patrons and had ample time and means to defuse the situation. Del Lago’s duty arose not because of prior similar criminal conduct but because it was aware of an unreasonable risk of harm at the bar that very night. When a landowner “has actual or constructive knowledge of any condition on the premises that poses an unreasonable risk of harm to invitees, he has a duty to take whatever action is reasonably prudent" to reduce or eliminate that risk.

The ruling drew two very lengthy dissents. They point out that the rule in Texas has always been that a possessor of land discharges his duty to protect an entrant, including an invitee, from a condition that poses an unreasonable risk of harm by giving an adequate warning. Yet the court now holds that “in some circumstances, no warning can be adequate.” The court, however, did not explain when and how such situations arise so that a landowner can take measures to reduce his risk. It also did not explain why no warning could have been adequate in this case (where the danger was obvious and Smith was a willing brawler who could have avoided his injury by simply leaving the bar at any time after trouble began to brew.

In his dissent Justice Wainwright examined Palsgraf v. Long Island Railroad and Texas' views about whether we follow an ordinary prudence rule or whether we impose on all actors a duty to the whole world and he concluded that Texas had always followed the lead of the majority opinion in Palsgraf.  

The majority gave short shrift to one of the key problems with this case.  While the case was presented to the jury on a premises liability theory (defect in the physical premises itself), one of the major factors in holding the bar liable was a negligent activity (serving drinks to belligerent people, omitting to call the police to break up the fracas).  Serving drinks in a bar cannot be a premises defect. That is what bars do.  However, serving them to drunk, belligerent customers can be negligent, as in a dram shop case.  This is a key distinction because obvious dangers and warnings are often not sufficient in negligent activity cases – it is not enough to warn someone that you are spraying the floor with oil in a grocery story as the person walks by and slips (this is the seminal fact pattern in a negligent activity case).  So instead, the majority has created an exception to premises liability law when it could have simply sent the case back to the trial court to be tried and presented to the jury under the appropriate tort – the negligent activity of serving drinks to drunk, belligerent customers and not calling the police.

How will this ruling affect toxic tort claims by contractor employees? Is it no longer enough to warn of the risk and to advise as to how it might be avoided? And if a hazard, such as an unguarded loading dock, is open and obvious is the premises owner now obligated to actively prevent the contractor from falling off? And what exactly is the something "more than a warning" that a prudent premises owner must now undertake to discharge this new duty?

Premises liability law, which had after many long years finally become understandable, predictable and workable has suddenly become very uncertain.

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NJ Appellate Court Upholds $30 Million Award: Is a New Mesothelioma Exception to Traditional Causation Analysis Emerging?

In Buttitta v. Borg-Warner, et al a New Jersey appellate court appears to embrace the scientifically indefensible "no safe level" risk/causation conflation in upholding a huge award to a plaintiff with a lower asbestos burden than an average American; likely all of whom are exposed to chrysotile, a ubiquitous and naturally occurring mineral.

Clearly a new front in an old war has opened. Seemingly few are prepared for this post-epidemiological world.

Also of interest is the court's approval of prior decisions based on an Illinois appellate court's discussion of the substantial factor test:

"The substantial factor test is not concerned with the quantity of the injury-producing agent or force but rather with its legal significance... Where there is competent evidence that one or a de minimis number of asbestos fibers can cause injury, a jury may conclude the fibers were a substantial factor in causing a plaintiff's injury". Citing Wehmeier v. UNR Industries, Inc., 572 N.E.2d 320, 337 (Ill. Ct. App. 1991).

That's pretty much the essence of the "redistributive justice" view of tort law in which the actor's conduct is not at issue but rather whether it contributed, however infinitesimally, to the plaintiff's injury. Practically speaking the litigation then will remain focused not on whether a defendant committed a wrong but rather on which defendant is most able to pay since asbestos fibers have been found on just about every surface and in countless products.

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Mortality: Postponed

Apparently forty really is the new thirty. In several (free) reviews of the state of current knowledge on aging you'll read that life expectancy hasn't, contrary to popular opinion, reached any preset limit and that those who reach "old age" in good health (Americans, Swiss and Japanese, anyway) not only have a lot of life left ahead of them but the accretion of extra life is accelerating. In the paper "Biodemography of Human Ageing" there's an especially eye-popping graph showing the age at which remaining life expectancy is either five or ten years for women. American women lead Swiss women and look to be pulling away, almost going straight up, at a rate similar to Japanese women.

That all this extra life will bring profound political and economic changes almost goes without saying. In personal injury litigation some of the changes wrought by significantly increased life expectancies are already here.

When I got out of law school a good liability wrongful death cancer claim by the children of an eighty-something decedent might have settled for $50,000.00.Typically there would have been little in the way of medical bills, nothing in the way of lost wages and the adult children would have been thought lucky to have had their parents around for so long. At one point I collected all the awards to grown-up and on-their-own children (40+) in toxic tort wrongful death cases for several years here in Texas and the average was $30,000/child with a median of about $25,000.

Recently I was involved in a case in which the decedent had been making $150,000/yr at age 80, incurred over $300,000 in medical bills and the family had already collected more than $1,000,000.00 settlements. And a focus group, in another matter, when asked "to what age should people reasonably expect to live" collectively picked 85 as the magic number though almost half said the number should be 100. One hundred. And do you know what? A child born today has better than even odds of living to 100 according to the actuaries.

Not only are damages going up, people are dodging things like heart attacks and strokes that used to kill them at much younger ages and so are living long enough to develop diseases with extraordinarily long latent periods. Expect to see more, and more different kinds of latent disease litigation.

Finally there's the future. First though imagine you're in a Navy shipyard in 1941 and someone tells you that the material you're using might kill you when you're in your eighties. Since your life expectancy is sixty or so you might not be too alarmed. In fact, you might be relieved since the eighty somethings you know are woefully decrepit. Now come back to 2010 and imagine someone just told you that using a common and ubiquitous material may cause you to die, prematurely, of cancer ... at 125. What would you do? What should we do?

All of the articles about aging (or ageing - blame the Brits) are free (and excellent) in this month's Nature Insight. If you're daunted by the science try the podcast instead.

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Third Time's The Charm: Ohio Upholds Tort Reform Employment Intentional Tort Statute

In a pair of decisions released on March 23, the Supreme Court of Ohio upheld RC 2745.01, which requires a showing of deliberate intent to make out a case of employment intentional tort for claims arising on and after April 7, 2005. This will make proof of employment intentional tort considerably more difficult in Ohio than under the prior standard, which required only a showing of knowledge of “substantial certainty” of injury. This ruling from the Supreme Court of Ohio is also notable in light of the Court’s prior decisions, striking down two prior tort reform efforts in this area. The two opinions, Stetter v. R.J. Corman Derailment Servs, LLC and Kaminsky v. Metal and Wire Prods Co., are available here.

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What Impact Will "Enhancing Tracebacks and Recordkeeping" Have on Farmers' Markets?

“There are certain things only a government can do. And one of those things is ensuring that the foods we eat are safe and do not cause us harm.”  

That's a quote from President Obama that appears on the FDA's food safety website and is undoubtedly an indication of increasing federal regulation of food in the years to come.  It's expected that by May of this year a bill to modernize the FDA will become law.  Both the House and Senate versions of the bill require the establishment of a tracing system for contaminated food back to its source within two days.  While tagging foods so that they can be traced back to their source may be onerous for industrial-scale producers, for farmers' markets, truck farmers, and the whole locally grown / sustainability movement this requirement may prove to be crippling. 

The final bill will likely incorporate some sort of requirement for studies or pilot projects to determine the most effective and least expensive method of traceback and recordkeeping.  Any obligations eventually imposed won't become effective for eighteen months to three years.  Expect to see considerable debate about these provisions in the next couple months.

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The Texas Supreme Court Has Decided Another Arbitration Issue

The Texas Supreme Court has just decided another arbitration issue in the case of East Texas Salt Water Disposal Company, Inc. v. Werline, 53 Tex. Sup. Ct. J. 410 (Tex. 2010). This time it has further defined the limits of trial court’s ability to review arbitration decisions.

Werline was an employee of East Texas Salt Water Disposal. He had an employment contract that directed arbitration over any employment disputes. He also had a severance provision if he was terminated without cause. Werline’s employment ceased and he sought to enforce the severance provision. The parties proceeded to a three-day arbitration hearing in front of an AAA arbitrator. The arbitrator awarded in favor of Werline. East Texas Salt Water Disposal petitioned the district court to vacate, modify or correct the award on the basis that it was so against the great weight of the evidence that the arbitrator manifested bias.

The trial court vacated the award, determined all the material facts and issues in East Texas Salt Water Disposal’s favor and directed another arbitration to confirm the facts the court had found. Werline appealed and the court of appeals reversed and rendered in favor of Werline. East Texas Salt Water Disposal appealed, arguing that the court of appeals had no jurisdiction to hear the appeal.

The Supreme Court held that the court of appeals did have jurisdiction to hear the appeal from the trial court’s obviously erroneous decision.

The Texas Supreme Court then took the opportunity to remind the parties, once again, that there is limited trial court review of arbitration awards. The review is limited to the grounds expressly enumerated by Texas Arbitration Act section 171.098(a). In this way, the Texas Supreme Court’s decision is consistent with the United States Supreme Court’s decision in Hall Street v. Mattel, 128 S.Ct. 1396 (2008) decided recently on similar issues under the Federal Arbitration Act, which the TAA is modeled after.

Justice Jefferson, leading the dissent, argued that the limited issue presented on appeal, the appealability of the trial court’s order, should have been decided differently. He held that there was not sufficient finality in the trial court’s order to make it appealable. However, this is inconsistent with the purpose of the TAA to make arbitration faster and cheaper than litigation. As the Fifth Circuit stated recently in Citigroup Global Markets, Inc. v. Bacon, arbitration should be the end, not the beginning of the litigation. If the trial court’s order were not appealable, multiple arbitrations would have occurred based on reasons not listed in the statute.

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BP Verdict For Toxic Exposure Reduced by $100 Million

Yesterday, the federal judge that presided over the Garner v. BP trial issued a memorandum opinion and final judgment in which he ruled that gross negligence was not proven by clear and convincing evidence by plaintiffs as a matter of law. Judge Kenneth Hoyt’s opinion set aside all exemplary damages awarded by the jury in the first trial of ten plaintiffs that claimed injuries as a result of chemical release in 2007. Judge Hoyt’s opinion stated that plaintiffs failed to satisfy the objective test for gross negligence which requires a showing of an extreme risk of harm – “one that involves both high probability and high potential severity” of an occurrence. In addition, plaintiffs failed to demonstrate the requisite specific intent that showed BP ignored an obvious or known risk and took no precautions that would minimize or arrest the harm anticipated. According to Judge Hoyt, BP had implemented safety precautions which included monitors on workers and at various locations on the plant to detect the presence of toxic chemicals.

The judgment found that BP was responsible for the chemical release and permitted plaintiffs to recover actual damages which totaled $340,659.77.

Plaintiffs’ counsel Tony Buzbee told the Houston Chronicle that the first trial was “just a skirmish in the war.” Over 130 plaintiffs have pending claims in this litigation which remain to be tried.
 

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Everything is More Carcinogenic in China

"Tobacco smoking is responsible for one-third of the total cancer deaths among men." See "Estimation of Cancer Incidence and Mortality Attributable to Smoking in China". Secondary smoke exposure is said to be responsible for more than 11% of all cancer deaths in women.

Do you ever get the feeling that China is just going through what the U.S. went through in the 1960s, 1970s and 1980s when epidemiology and mass health panics were all the rage? If so, and if a "redistributional justice" model of tort law can be introduced in China, it may be deja vu all over again for classic mass tort litigation.

Madison County Jury Rules For Ford in First Asbestos Trial of 2010

A Madison County jury rendered a defense verdict in an asbestos trial that ended Friday. Plaintiffs Larry and Meta Williams claimed he developed mesothelioma from his work with friction products that contained asbestos. The lone defendant at trial was Ford.

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Popular Beliefs About Bisphenol A Have Been Repeatedly Falsified, Yet the Controversy Continues. Why?

Claims that bisphenol A causes hormone disruption have been refuted again and again by large, independent studies the results of which have been published in peer reviewed papers. Yet, based on nothing more than an uninspired theory (that estrogen-like molecules ought to do what estrogen does) and a few, small, poorly controlled studies the results of which can't be reliably reproduced elsewhere, the effort to ban a product that prevents bacteria from infecting much of the food you consume continues to accelerate. How could this be?

You can find Richard M. Sharpe's answer in "Is It Time to End Concerns over the Estrogenic Effects of Bisphenol A?" published in the journal Toxicological Sciences (free access!).

Like the autism/vaccine, limb reduction/Bendectin controversies the bisphenol A panic has spread like a virus. And if those past controversies are any guide it'll be several more years before civilization's immune response, empiricism, is able to bring us collectively back to our senses. In the meantime expect opportunistic infections to take advantage of the situation.

SCOTUS Grants Review in Vaccination Preemption Case

Yesterday the U.S. Supreme Court granted a petition for writ of certiorari in Bruesewitz v. Wyeth, Inc. and will review the Third Circuit’s holding that a plaintiffs’ design defect claims against the manufacturer of a vaccination were expressly preempted by the 1986 National Childhood Vaccination Injury Act (“NCVIA”) and that plaintiffs failed to establish a manufacturing defect or a warning defect claim under the Act.

In a footnote in the Bruesewitz opinion the Third Circuit had distinguished the Supreme Court’s opinion in Wyeth v. Levine in which the Court held that federal law did not preempt state tort claims that alleged that a drug manufacturer failed to adequately warn of the dangers associated with a drug on the basis that unlike the NCVIA, there was no express preemption provision in the Food, Drug, and Cosmetic Act (“FDCA”). Another distinguishing factor was Congress’ silence on the issue of preemption in the FDCA “coupled with its certain awareness of the prevalence of state tort litigation” which was “powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness” as the Court stated in Levine. In addition, the Third Circuit noted that Levine recognized that under federal law, a drug manufacturer could strengthen a drug’s label without preapproval from the FDA, which “stands in contrast to the FDA’s far-more extensive control and oversight of the drug’s design and alternation.”

Also the Third Circuit had disagreed with the interpretation of the Georgia Supreme Court on this issue. In American Home Products Corp. v. Ferrari (in which a petition for writ of certiorari is pending), the Georgia high court had ruled that the Vaccine Act “clearly did not preempt all design defect claims against vaccine manufacturers, but rather provides that such a manufacturer cannot be held liable for defective design, if it is determined, on a case-by-case basis, that a particular vaccine was unavoidably unsafe.” The Third Circuit noted in Bruesewitz that if the NCVIA was interpreted to permit a case-by-case analysis of whether “particular vaccine side effects are avoidable, every design defect claim is subject to evaluation by a court.”

It will be interesting to see how the Supreme Court resolves the split between the Third Circuit and the Georgia Supreme Court on this issue.

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West Virginia Asbestos Plaintiffs Must Disclose Bankruptcy Trust Information

Score one for transparency and fairness in the Mountain State.

The West Virginia Record reported in this article on March 3 that Circuit Judge Ronald Wilson has now ordered that all asbestos plaintiffs in West Virginia must henceforth disclose which bankruptcy trusts they have communicated with and against which trusts they might have a claim. The purpose of the order is to ensure that defendants in asbestos cases receive proper credit when plaintiffs are paid by trusts of bankrupt defendants.
 

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Be Careful What You Wish For...[Texas Arbitration Edition]

The case of Cull v. Perry Homes is long and winding and fits the old adage of being careful what you wish for; especially in litigation. Robert and Jane Cull of Mansfield, Texas bought a home from Perry Homes for $233,730. They alleged it had serious structural problems. They sued Perry Homes and two warranty companies in Texas District Court. One of the warranty companies moved to compel arbitration with the American Arbitration Association pursuant a contract clause. The Culls responded with a 79-page objection which called the AAA, among other things, “incompetent, biased, and fails to provide fair and appropriate arbitration panels.” The case proceeded in court. There was extensive discovery conducted, including 14 depositions and five motions to compel by the Culls. Four days before trial, the Culls moved to compel arbitration. The trial court agreed. The Supreme Court denied a petition for writ of mandamus blocking the move to arbitration.

The arbitrator gave the Culls an $800,000 award, including punitive damages and damages for mental anguish (things arbitration panels are supposed to protect litigants from versus jury trials).

Perry Homes appealed. The Texas Supreme Court reversed; not the arbitration award itself – for which the law is extremely deferential – but the trial court’s decision to go to arbitration.

The Supreme Court stated that the key issue was whether the party moving to compel arbitration had substantially invoked the litigation process. In this case, it clearly had. There is not much more that the Culls could have done to invoke litigation short of going through the trial itself. The plaintiff’s 79-page objection to the AAA seemed to have a large part in the Court’s decision.

On retrial, the jury awarded the Culls $51 million.

Perry Homes has incrementally gotten what it wished for (an arbitration set out in its contract, a new trial after the arbitration gave a bad result), with increasingly bad results. The Supreme Court’s 2008 opinion received lots of press for its seeming favoring of a well-connected defendant over even its historical favor of arbitration.

The case continually made for favoring arbitration is that it reduces cost and time. This frequently does not occur. Perhaps we should go back to favor arbitration only in cases where experts are needed to determine the outcome, not for run-of-the mill private litigation that has until recently been the purview of our public courts.

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No Employment Intentional Tort Liability For Occupational Exposures Prior To 1982? A Potential Emerging Trend In Ohio Law

We have been watching with interest recent developments in a solvents case currently pending in Summit County, OH: Widican v. Bridgestone/Firestone North American Tire, LLC, et al. A summary judgment order entered in that case may portend a serious body blow to employee "intentional tort" claims against Ohio employers for occupational illnesses with long latencies.

Beginning in 1939, worker's compensation was the exclusive remedy that Ohio workers could seek against their employers for injuries suffered in the course of their employment. That is to say, workers' compensation preempted employer tort liability. This involved the trade-off typical of most workers compensation systems: the employee received reliable compensation for workplace injuries without having to prove fault, and the employer in return received a predictable and reasonable cap on its liability for such injuries.

All that changed in 1982. That year, the Ohio Supreme Court held in Blankenship v. Cincinnati Milicon Chemicals, Inc. that there was an exception to worker's compensation preemption. If the employee could prove that the employer intended to harm him/her, he/she could recover both workers compensation and the full range of tort damages against his/her employer. Two years later, the Ohio Supreme Court in Jones v. VIP Development Company further expanded the exception, holding that "intentional tort" could be established by showing that the employer knew that injury to the employee was "substantially certain." The requisite "intent," the Court later explained in Fyffe v. Jeno's, Inc., was something more than "reckless" or "willful and wanton" conduct, but something less than specific intent to harm.

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Second Court of Appeals' Interpretation of Borg-Warner

In a perplexing opinion the Second Court of Appeals affirmed a summary judgment granted in favor of a manufacturer of asbestos-containing joint compound in a mesothelioma case. As we mentioned in our prior posting on this case, the appeal involved the review of the Texas asbestos MDL pre-trial court’s ruling that qualitative testimony of Dorman Smith’s use of a Kelly-Moore product “on a regular basis” was insufficient.

In Rosemary Smith, et al v. Kelly-Moore Paint Company, the appellate court first addressed and rejected plaintiffs’ contention that Borg-Warner only applied to asbestosis cases and did not apply to mesothelioma cases.

Second, in contrast to the pre-trial court’s ruling that plaintiffs’ qualitative evidence was insufficient, the appellate court reviewed the exposure testimony of fact witnesses, the opinions of plaintiff’s expert, and the opinion of a defense expert that opined that Dorman’s cumulative total exposure to asbestos amounted to 9 to 15 fibers/cc years over the course of his career and stated that “the Smiths at least raised a genuine issue of material fact as to the aggregate dose of Kelly-Moore asbestos-containing joint compound (and total asbestos fibers) to which Dorman was exposed.” The appellate court held that “the Smiths raised a genuine issue of material fact as to the Lohrmann factors.”

This holding is puzzling as the Texas Supreme Court made it clear in Borg-Warner that “proof of mere frequency, regularity, and proximity is necessary but not sufficient, as it provides none of the quantitative information necessary to support causation under Texas law.

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SCOTUS Adopts The "Nerve Center" Test to Determine a Corporation's Principal Place of Business

Yesterday in a unanimous opinion (Hertz Corp. v. Friend et al.) the U.S. Supreme Court held that the “nerve center” test will determine the location of a corporation’s “principal place of business” for ascertaining whether a federal court can exercise diversity jurisdiction.

The Supreme Court noted that since Congress codified that a corporation is a resident of the State in which it was incorporated and the State of its “principal place of business” appellate courts have adopted numerous approaches in determining the location of a corporation’s principal place of business. Some courts applied the “nerve center” test for corporations with “far-flung” business activities which focused on the location of the corporation’s decision-makers. Other courts focused more heavily on where a corporation’s actual business activities were located. The number of factors grew as courts combined aspects of the “nerve center” and “business activity” tests to look to a corporation’s “total activities,” sometimes to try to determine what has been described as the corporation’s “center of gravity.”

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Will Proposed Stricter EPA Limits on Perchloroethylene Usher in the Next "Great American Pants Suit" Against Drycleaners and Chemical Manufacturers?

Readers of The Wall Street Journal may recall the saga of the administrative law judge in NYC who sued a family-owned dry-cleaner for $57 million over a lost pair of pants. Dubbed “The Great American Pants Suit” by this WSJ article, the judge’s law suit was touted by some as emblematic of the flaws in our tort system. When the judge’s suit failed to produce a windfall verdict, dry cleaners everywhere presumably breathed a sigh of relief.

Recent word from EPA, however, may give much greater cause for alarm for the dry cleaning industry. Perchloroethylene, “perc,” PCE, TCE, tetrachloroethyene and tetracholorethylene are solvents used in dry cleaning. Approximately 28,000 U.S. dry cleaners use this family of chemicals, which are the only air toxic emitted from the dry cleaning process. PCE has been subject to limited EPA regulation under the Toxic Substances Control Act (TSCA), because it was in use long before TSCA was passed in 1976. However, according to this Columbus Dispatch article, EPA Administrator Lisa Jackson indicated in a speech in Columbus last week that she believes TSCA is “toothless,” and intends to press Congress for increased EPA authority to review chemicals. Among proposed changes in EPA regulation of PCE: classification as a “likely” carcinogen (rather than a “possible” carcinogen), and reduction in airborne limits. Litigation over injuries attributed to PCE and other chlorinated solvents is nothing new, of course. However, if Administrator Jackson’s proposed changes are implemented, exposure claims in general and cancer claims in particular are likely be significantly affected by the ensuing “hindsight bias” engendered by the new state of the art.

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How Can Something So Green Be So Bad for You?

Under current federal incentives for “green” energy sources, developers have been rushing to place wind turbines in many rural areas. Indeed, even before the Obama administration’s current emphasis on renewable energy, wind farm development has grown rather dramatically in the last decade, as shown by this time elapsed map of installed wind capacity.

In a recent ABA Journal article, the author notes that many neighbors of proposed wind farms have been challenging the placement of the giant turbines near their homes. Most such challenges have occurred before local land use authorities or state public utility boards, but some have been filed in court.

Most interesting from the mass tort perspective is this: at least some challenges to wind turbine developments have been based upon the purported human health effects of the turbines. Nearby homeowners claim that the low level sound, vibration and shadow flicker from the spinning turbines cause a host of non-specific complaints, such as sleep disruption, headaches, nausea and fatigue.

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California's Second Appellate District Joins Other California Courts of Appeals in Upholding Summary Judgment for Equipment Manufacturers in Asbestos Case

In Hall v. Warren Pumps LLC, et al., the California Court of Appeals, Second Appellate District, Second Division, held last week that manufacturers of pumps and valves who did not manufacture, sell or distribute asbestos insulation applied to their products are not liable under California law for injuries caused by that insulation. In so holding, the Second Appellate District joins the First Appellate District (Taylor v. Elliott Turbomachinery Co., Inc.), and the Second Appellate District, Third Division (Merrill v. Leslie Control, Inc.), both of which reached the same conclusions.

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FDA Approves New Indication for Crestor

Hooray!

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Illinois Supreme Court: Medical Malpractice Caps Unconstitutional

Yesterday the Illinois Supreme Court issued an opinion in which they rejected statutory caps on non-economic damages in medical malpractice actions as unconstitutional under the state’s constitution. This isn’t entirely surprising as the Illinois Supreme Court had previously held in Best v. Taylor Machine Works, 179 Ill. 2d 367 (1997) that Section 2-115.1 which provided for caps on non-economic damages in all cases were unconstitutional as they violated the special legislation clause which was intended “to prevent arbitrary legislative classifications that discriminate in favor of a select group without a sound, reasonable basis.” In Best, the court also noted that although the legislature may limit certain types of damages, such as damages recoverable in statutory causes of action, the limitation on damages in section 2–1115.1 violated the separation of powers clause.

Following its holding in Best, the Illinois high court found that the caps in the medical malpractice statute was an unconstitutional legislative remittitur that violates separation of powers. According the court, under the statute the trial court is “required to override the jury’s deliberative process and reduce any non-economic damages in excess of the statutory cap, irrespective of the particular facts and circumstances, and without the plaintiff’s consent. Section 2–1706.5 thus violates the separation of powers clause because it ‘unduly encroaches upon the fundamentally judicial prerogative of determining whether a jury’s assessment of damages is excessive within the meaning of the law.’ Best, 179 Ill. 2d at 414. Section 2–1706.5, like section 2–1115.1, effects an unconstitutional legislative remittitur.”

The Court continued that “[t]he separation of powers clause prohibits one branch of government from exercising “powers properly belonging to another.” Ill. Const. 1970, art. II, §1. Thus, the inquiry under the separation of powers clause is not whether the damages cap is rationally related to a legitimate government interest but, rather, whether the legislature, through its adoption of the damages cap, is exercising powers properly belonging to the judiciary. In other words, does the statute unduly encroach on the judiciary’s ‘sphere of authority’….”
 

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What Do Beer Pong and Voir Dire Have in Common?

A lot, actually. Or so it seems from this excellent and highly readable essay on practical jury selection. Be sure to read all the way through the jury consultant's response.

Hat tip: Marginal Revolution 

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$500 Million Case?

Eight contract workers recently filed suit against BP Products North America Inc. and Pasadena Tank Corp. in Galveston County claiming they were exposed to “extremely high levels of benzene,” at BP’s Texas City refinery on Aug. 19, 2009. The exposure allegedly occurred when a damaged pipe began "spewing" chemicals in an area where the plaintiffs were working. According to the plaintiffs, they immediately evacuated the area and sought medical treatment where they learned they had been exposed to benzene.

The plaintiffs now seek $500 million in damages for pain and suffering, and mental anguish associated with being exposed to benzene, yet they make no claims of suffering from benzene-related illness. Notably, these allegations follow a $100 million verdict (mostly punitive damages) handed down against BP less than a month ago to workers who were briefly sickened by unexplained fumes (maybe CS2) at BP's Texas City refinery.  .

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California Supreme Court To Review Appellate Split

The California Supreme Court will review an asbestos case against valve and pump manufacturers that will provide the opportunity to reconcile divergent California appellate court views on the issue of whether a manufacturer had a duty to warn of the dangers associated with the subsequent application of asbestos-containing materials to its products.

In O’Neil v. Crane Co., plaintiffs asserted mesothelioma claims of a naval officer that was exposed to asbestos during his military service on ships. A panel of the California Court of Appeal, First Appellate District reversed the trial court and permitted the case to proceed against manufacturers of pumps and valves for harm caused by asbestos-containing replacement packing and insulation which were used with their products but they didn't manufacture.

The appellate court disagreed with the reasoning of the California Court of Appeal, First Appellate District, in Taylor v. Elliott Turbomachinery Co., 171 Cal. App. 4th 564 (2009). Although the facts were very similar to O’Neil, the appellate court in Taylor rejected liability for pump and valve manufacturers as they were manufacturers of non-defective component parts of a greater whole, and they didn't manufacture the asbestos-containing products that caused the harm.

To further complicate the issue, a different panel of the Second Appellate District agreed with the reasoning in Taylor and held that valve manufacturer “owed no duty to warn against dangers in products, used in association with or as replacement parts of its valves, which it did not manufacture or supply.” For detailed write-up of the Second Appellate District's opinion, see our earlier post on Merrill v. Leslie Control, Inc.

 

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What's the Old Saying About Christmas Juries?

As my mentor used to say, "most people like to help others; and they really like to help when they can do it with someone else's money." 

$100 million is a lot of help.

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ECHA Begins to Publish Hazard and Safe-Use Chemical Information

As part of its REACH effort the European Chemicals Agency (ECHA) has today launched what it describes as the "pilot form" of a webpage which, it is hoped, will ultimately "allow EU citizens to make informed decisions about the use of chemicals to which they may be exposed."

Today's press release has a link to the new database. When using the database search function be sure to check the "I accept the Terms and Conditions" box or it won't work. Gotta love lawyers. Anyway, when looking for something like benzene be sure to look in the "Pre-Registered Substances" directory because it won't be found in the "Registered Substances" directory and the search engine apparently doesn't look outside of whatever directory you're in.

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An Interesting Question From the Jury

In the recently decided Pennsylvania case of Hicks v. Dana Companies, LLC  the appellate court considered whether the trial court had committed error in its handling of the following question posed by the jury after two-and-a-half hours of deliberations:

"Judge Lynn, can we please have verification as to what a 'factual cause' is? To determine such, do we consider each company's product individually or all collectively?"

Rather than answer the question, which actually got right to heart of the matter, the trial court read the following instruction:

"If you find that a defendant's asbestos-containing product was defective, the defendant is liable for all harm to the plaintiff caused by such defective condition. A defective condition is [sic] the defendant's asbestos-containing product is the factual cause of the mesothelioma suffered by the plaintiff if the mesothelioma would not have occurred without exposure to the defendant's defective product. That's factual cause."

Is it any wonder that jury questions are invariably found to be confusing and often result in jurors rendering verdicts they didn't mean or want to render?

Anyway, the jury's question was a profound one. In this age of peripheral defendants, typically none of whose products alone could have produced mesothelioma, is it fair to lay at any one defendant's feet "all harm to the plaintiff" when alone its product could have produced no harm at all?

The opinion is significant in at least two other respects. First it embraces the logical fallacy of conflating risk and causation by approving of causation testimony founded only on the observation that in a dose response disease each quantum of dose increases risk. Second it appears to support the contention that a defendant's application of a warning label to its product is a tacit admission that the product causes the harm warned of.

While the court goes out of its way to distinguish this case from the Pennsylvania Supreme Court's ruling in Gregg v. V-J Auto Parts Company it is difficult to see how it has in fact done anything other than accept the one fiber theory so long as plaintiff has an expert willing to swear to it.

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Texas Supreme Court Reverses Award Against Whirlpool, Reaffirms Expert Reliability Standards

The Texas Supreme Court released its opinion today in the Whirlpool v. Camacho case. Joab Camacho, a minor, burned to death in a trailer fire allegedly caused by a defectively designed Whirlpool dryer. The plaintiffs’ expert, who had never examined the dryer as it had been discarded, nevertheless opined that lint from the dryer somehow collected in a corrugated exhaust shoot, backed up through the mechanical systems of the dryer, caught fire in the tumbler, smoldered when the dryer shut off, was reignited by oxygen when the door was opened and then ignited the clothes in the dryer. Plaintiffs claimed a safer alternative design would have utilized a smooth exhaust shoot. The sole support for the opinion of plaintiffs’ expert was a review of an allegedly similar dryer and Consumer Product Safety Commission (CPSC) reports of various dryer tests. The jury accepted the assessment and awarded $14 million in damages against Whirlpool.

The Texas Supreme Court conducted a full review of the expert evidence and found Plaintiff’s expert ultimately unreliable under Robinson v. Merrill-Dow. For example, plaintiffs’ expert had not conducted any tests on the dryer in question nor on any similar dryer and could not explain why tests to see if the model in question posed such a risk wasn’t feasible. Further, his opinions were made solely for litigation. Finally, the only data he did rely upon was not sufficiently similar to that for the dryer and circumstances in Camacho’s case to make it reliable.

With this opinion the Texas Supreme Court has again confirmed that the mere ipse dixit of an expert witness is not sufficient to establish the reliability of the Robinson relevance/reliability analysis.
 

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California Appellate Court Muses that Secondary Exposure Claims May Be Valid

In a recent published opinion the California Court of Appeal, Second Appellate District opined that for a wife to pursue a claim against her husband’s employer for so-called take home exposures, her complaint should specify the chemicals involved and injuries alleged. (Oddone v. The Superior Court of Los Angeles County, Cal. Ct. App., No. B213784, Nov. 24, 2009).

The plaintiff had alleged that she was secondarily exposed to chemicals from her husband and his work clothes. She also asserted claims on behalf of her husband for his personal injuries which remain pending. Her husband had worked for 33 years processing motion picture film for Technicolor Inc. She specified in her complaint her husband’s injuries (glioblastoma multiforme and skin rashes) and specific chemicals that allegedly harmed him (formaldehyde and perchloroethylene), but she made vague allegations regarding her own personal injury claims against Technicolor. She alleged that she was injured from chemical substances that her husband brought home with him either on his body or clothes but failed to identify her specific injures or chemicals that caused her harm.

The defendant moved to dismiss her secondary exposure claim on the basis that it owed no duty to its employee’s wife. The trial court agreed and this appeal ensued.

The appellate court acknowledged that “[t]here appears to be no reported California decision addressing the scope of the defendant’s duty in a case where the plaintiff claims to have been injured as a result of secondary exposure to chemicals.” However, the court continued that “[g]iven appropriately specific allegations, this may be quite possible.”

The court explained that in this case “petitioner’s allegations simply do not establish any connection, much less a close connection, between the defendant’s conduct and her alleged (and unspecified) injuries.”

According to the court, a “close connection” is required because under Rowland v. Christian, 69 Cal.2d 108 (1968), it is one of several significant factors to consider when determining whether a duty exists to an injured party in this circumstance. Although the Rowland factors are to be balanced against one another, the court stated the “close connection” factor is especially important in a secondary exposure suit.

“That connection is only shown by setting forth specifically which chemicals cause which specified injuries,” said the court. “In a secondary exposure case, the allegation that as a result of the exposure the specified chemical entered the plaintiff's body is of particular importance. Central issues in such a case are whether secondary exposure to a specified chemical is even possible and, if it is, whether the exposure will result in the ingestion of the chemical into the plaintiff's body.”

As the plaintiff failed to identify a specific chemical or to specify any one of her alleged injuries she could not “connect any specified chemical or chemicals to a specific injury or injuries” and so, in this case, her take home claim failed.

EPA: Carbon Dioxide Threatens Public Health and the Environment

This afternoon the EPA announced that “greenhouse gases (GHG) threaten the public health and welfare of the American people.”

According to the press release the EPA’s final findings responded to the 2007 U.S. Supreme Court decision (Commonwealth of Massachusetts et al. v. Environmental Protection Agency, decided Apr. 2, 2007) that GHGs fit within the Clean Air Act definition of air pollutants. The findings allow EPA to finalize the GHG standards proposed earlier this year for new light-duty vehicles as part of the joint rulemaking with the Department of Transportation.

The EPA’s endangerment finding covers emissions of six gases – carbon dioxide, methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons and sulfur hexafluoride.

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Are Big Punitive Awards in HRT Cases Justified?

Law.com is reporting that Philadelphia juries have awarded a total of $103 million in punitive damages alone to two women in separate breast cancer product liability trials. The women claimed that hormone replacement therapy (HRT) was responsible for their subsequent development of breast cancer.

In light of the recent controversy over the use of Bayesian decision-making approaches to mammography and Pap testing in which probabilities of outcomes are estimated and benefits are then weighed against costs (including other bad outcomes) I thought it might be of interest to see if such an approach had been applied to HRT. Sure enough, "Bayesian Meta-analysis of Hormone Therapy and Mortality in Younger Postmenopausal Women" was just published in The American Journal of Medicine.

So what does it show? It shows that across a number of randomized controlled trials of HRT in postmenopausal women under 60 those women had a reduced overall mortality compared to those postmenopausal women under 60 who weren't on HRT.

As is often the case in these modern times science does not yield a cure but does allow one to pick one's poison as it were; not to avoid death but to influence the odds of whether you die of stroke instead of breast cancer.

TSCA Reform Hearing- Prioritizing Chemicals for Safety Determination

The Subcommittee on Commerce, Trade, and Consumer Protection held a hearing titled, "Prioritizing Chemicals for Safety Determination," on Tuesday, November 17, 2009, in 2322 Rayburn House Office Building. The hearing examined the options for prioritizing chemicals for safety determinations in the event that the Committee amends the Toxic Substances Control Act (TSCA).

See the Energy and Commerce's website for the testimony that was given on Tuesday, Nov. 17, including testimony by the EPA.
 

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Florida Jury Awards $300 Million to Smoker With Emphysema

This evening a Broward Circuit Court jury rendered a mega verdict against Philip Morris USA consisting of $56.6 million in past and future medicals plus another $244 million in punitives for good measure. The plaintiff is a 61 year old wheelchair-bound emphysema sufferer.

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Warnings Claim Preempted When the Railroad Crossing Improvements Were Federally Funded

In Missouri Pacific Railroad v. Patricia Limmer, et al., the Texas Supreme Court held that state law tort liability for inadequate warnings was preempted when the railroad crossing improvements were federally funded because federal regulations specify what warning devices should be used.

After her husband was killed at a railroad crossing, Patricia Limmer and her two daughters brought a wrongful death action against the railroad company that maintained the crossing. The Limmers alleged that the crossbucks (black-and-white, X-shaped signs that read “RAILROAD CROSSING”) provided inadequate warning for the railroad crossing and that the railroad was negligent in failing to remove a gravel pile and vegetation that restricted drivers’ view of approaching trains. The railroad contended that Limmers’ claims were expressly preempted by the Federal Railroad Safety Act (FRSA) of 1970. The trial court concluded that federal regulations did not apply and a trial on the merits resulted in a $5.1 million verdict in favor of the Limmers, which the court of appeals affirmed.

On a petition for review, the Texas Supreme Court determined that when railroad crossing improvements were federally funded, federal regulations specify what warning devices should be used, and the United States Supreme Court had held that section 20106 of FRSA expressly preempted state tort law actions challenging the adequacy of these devices (Norfolk Southern Ry. v. Shanklin, 526 U.S. 344 (2000)). Similarly, the Limmers’ sight-restriction claim was preempted as it was simply a restatement of their claim that the warning at the crossing was inadequate. Accordingly, the court reversed the court of appeals and rendered a take nothing judgment.
 

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Anti-Tort Reform Goodies Buried in Health Care Bill

The House version of the health care bill, titled “Affordable Health Care for America Act,” includes a section (pgs. 1431-33) for incentive payments to be made to each State that has a compliant alternative medical liability law. For those of you short on time, scroll down to the bolded portion of Section 2531.

SEC. 2531. MEDICAL LIABILITY ALTERNATIVES.

(a) INCENTIVE PAYMENTS FOR MEDICAL LIABILITY REFORM.—

(1) IN GENERAL.—To the extent and in the amounts made available in advance in appropriations Acts, the Secretary shall make an incentive payment, in an amount determined by the Secretary, to each State that has an alternative medical liability law in compliance with this section.

(2) DETERMINATION BY SECRETARY.—The Secretary shall determine that a State has an alternative medical liability law in compliance with this section if the Secretary is satisfied that—

(A) the State enacted the law after the date of the enactment of this Act and is implementing the law;

(B) the law is effective; and

(C) the contents of the law are in accordance with paragraph (4).

(3) CONSIDERATIONS FOR DETERMINING EFFECTIVENESS.—In determining whether an alternative medical liability law is effective under paragraph (2)(B), the Secretary shall consider whether the law—

(A) makes the medical liability system more reliable through prevention of, or prompt and fair resolution of, disputes;

(B) encourages the disclosure of health care errors; and

(C) maintains access to affordable liability insurance.

(4) CONTENTS OF ALTERNATIVE MEDICAL LIABILITY LAW.—The contents of an alternative liability law are in accordance with this paragraph if—

(A) the litigation alternatives contained in the law consist of certificate of merit, early offer, or both; and

(B) the law does not limit attorneys’ fees or impose caps on damages.

(b) USE OF INCENTIVE PAYMENTS.—Amounts received by a State as an incentive payment under this section shall be used to improve health care in that State.

(c) TECHNICAL ASSISTANCE.—The Secretary may provide technical assistance to the States applying for or receiving an incentive payment under this section.

(d) REPORTS.—Beginning not later than one year after the date of the enactment of this Act, the Secretary shall submit to the Congress an annual report on the progress States have made in enacting and implementing alternative medical liability laws in compliance with this section. Such reports shall contain sufficient documentation regarding the effectiveness of such laws to enable an objective comparative analysis of such laws.

(e) DEFINITION.—In this section—

(1) the term ‘‘Secretary’’ means the Secretary of Health and Human Services; and

(2) the term ‘‘State’’ includes the several States, District of Columbia, the Commonwealth of Puerto Rico, and each other territory or possession of the United States.

(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such sums as may be necessary, to remain available until expended.

No wonder it’s 1900+ pages long.

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Dihydrogen Monoxide - Another Dose Response Toxin

The maxim “the dose makes the poison” is regularly offered by defendants in toxic tort cases as a premise for the assertion that a particular dose was too small to have been toxic. To demonstrate the concept examples of toxicity due even to essential substances like water are deployed. I’ve done it myself and the retort from plaintiff’s counsel has been invariably mocking. Here are sixteen million reasons why they should reconsider.

 

The Fundamental Principle of the General-Specific Causation Dichotomy

The idea that there are two types of causation, one general and the other specific, is rarely enlightening but increasingly the source of confusion, mischief-making and legal bickering. Take for instance the recent per curiam and dissenting opinions in Huss v. Gayden.

In Huss the plaintiff claimed that the drug Terbutaline caused her to develop debilitating cardiomyopathy. At trial the court permitted some testimony by the defendant's expert to the effect that Terbutaline does not cause cardiomyopathy in humans but prevented him from testifying that Terbutaline did not cause Huss' cardiomyopathy. The holding on appeal was that the defendant's expert had not been allowed to fully express his views on general causation and so the case was reversed and remanded. The dissent vigorously objected, writing that the expert had indeed expressed to the jury all that needed to be said on the subject of general causation, that he was not, through education, training or experience, able to opine on the subject of specific causation and that the verdict should thereby stand.

The dissent, citing Tanner v. Westbrook, wrote that the court was required "to acknowledge the fundamental principle of the general-specific dichotomy: that a witness may be competent to testify about general causation but not specific causation." Now, before I discuss this "fundamental principle" (tomorrow) let's first think a bit about reasoning from the general to the specific.

Assume that Wilbur is a pig and the allegation is that Wilbur has been flying. My expert on pigs takes the stand and testifies "No pig can fly". This is of course a general statement about pigs; but Wilbur is a subset of pigs. My expert ought therefore be allowed to testify that Wilbur cannot fly, whether he's ever examined him or not, because what is true of pigs must necessarily be true of Wilbur. Imagine my dilemma if the dissent had its way and I was required to put on specific expert testimony to the effect that Wilbur hadn't been flying. Where exactly would I find someone with the education, training and expertise in recognizing (to paraphrase the test set out by the dissent) the prior flying habits of pigs "in a particular and unique case"?

Tanner on the other hand presents a distinctly different sort of issue. Let's go back to Wilbur. Now he's alleged to have incubated the H1N1 swine flu and given it to his owner, Zuckerman. The plaintiff's expert takes the stand and opines generally that pigs, being swine, are capable of incubating swine flu. He then concludes that Wilbur, being a pig, must have harbored the flu since he was capable of doing so and since Zuckerman now has the flu. Here the criterion of specificity is in order since not all pigs had the flu and since there were other possible non-swine vectors for Zuckerman's flu. Because plaintiff's expert never isolated antibodies to that flu strain from Wilbur's blood nor did he evince any expertise in the forensic diagnosis of H1N1 in pigs his specific causation testimony is unfounded and rightly excluded.

The real problem is that "the fundamental principle of the general-specific dichotomy" isn't fundamental because there's no real dichotomy. More on that tomorrow.

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John O'Quinn Dies in Car Wreck

John O'Quinn who did as much or more than anyone to change the nature of mass torts died today in an automobile accident in Houston.  I first saw Mr. O'Quinn try a lawsuit some twenty years ago when a client for whom we were preparing to defend three benzene leukemia cases sent me to watch the entire Skeen v. Monsanto trial.  O'Quinn already had a fearsome reputation and so, being a brand new lawyer and not knowing much about how lawsuits were really tried, I expected to see quite a spectacle.  Instead, I learned a lot about how to try a lawsuit.

I suppose I expected all-star wrestling but instead it was much more like a chess match.  By the time O'Quinn was done with voir dire the defendant was left with a panel ranging from bad to awful.  His command of the facts and ability to recall them in the minutest detail was amazing.  And every good cross-examination of one of his witnesses turned out, on re-direct, to have been a well-laid trap so that the witness was not only rehabilitated but the cross was made to appear disingenuous, at best.

Nevertheless, probably because I understood the defendant's case and the science behind it, I thought that the defendant would win.  So each week when I would call my Dad, who's been trying lawsuits for decades, and excitedly recount the week's events. I was always surprised when he would reply that it sounded to him as though the plaintiff was thoroughly thrashing the defendant.  He said that O'Quinn had spun a simple and emotive narrative into which all the pieces of the case easily fit whereas the defendant's story lacked a compelling theme and was overly complex. 

After closing arguments I made a wager with my Dad that the defendant would win.  My Dad predicted a verdict of $10 million dollars.  The jury awarded $100 million dollars in punitive damages alone.

A few years ago I was trying a mesothelioma case in Beaumont.  Down the hall O'Quinn was trying a Fen-phen case.  Suddenly there was a commotion in the hall and our judge sent the bailiff out to see what was happening.  She returned and handed the judge a note whereupon he asked the jurors to leave the courtroom.  After the jurors left Judge Sanderson said "they're not sure exactly how much it comes to but O'Quinn just got a verdict of more than $1 billion dollars for one wrongful death."

John O'Quinn's legendary trial skills need no further elaboration.  However, the impact on the law of his brand of mega-verdicts which posed existential threats to corporations has dramatically changed the practice and much remains to be said about it.  More thoughts on that in a future post.

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Chicken: The Next Mass Tort?

Two plaintiffs in Connecticut have sued Burger King, McDonalds and Friendly Ice Cream Corp. for failure to warn them that “well done grilled, or barbecued chicken contains chemicals known to cause cancer.” Plaintiffs, represented by the Cancer Project’s general counsel, allege that grilled chicken contains PhIP (2-Amino-1-methyl-6phenylimidazo [4,5-b]pyridine) a chemical that can increase a person’s risk of developing cancer even if consumed in very small amounts, according to a statement by the Cancer Project.

It is interesting to note that the plaintiffs seem not to have cancer. It is further interesting to note that the plaintiffs do not allege how much the risk of cancer is increased if consuming grilled chicken.

The crux of Plaintiffs’ alleged grief, as alleged in their complaint, is that if restaurants had truthfully informed consumers of the presence of a known carcinogen in their grilled chicken products, many consumers would have chosen to avoid the cancer risk by choosing healthier food options.

It seems that Plaintiffs should have to prove that they have actually been done some harm. If there is only an increased risk, that risk should be weighed against the risk of eating fried chicken, raw chicken, no chicken, a burger, or going hungry. Interestingly, the increased risk of cancer from grilled chicken may have to be juxtaposed against the risk of obesity from eating something fattier, though without PhIP.  Click here.

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$24 Million Meso Verdict Reversed; Bendix Letter Should Have Been Redacted

Plaintiffs alleged that Dr. Stephen Guilder was exposed to chrysotile asbestos in the 1970’s and 1980’s when he remodeled an attic, worked in road construction, and repaired automobiles. He subsequently developed peritoneal mesothelioma and sued Honeywell as successor to Bendix, Borg-Warner, Honda, and other defendants that settled before trial.

Honeywell filed a motion in limine to exclude or redact a portion of a Bendix employee’s letter to an asbestos supplier which was written in the late 1960’s on the grounds of relevance, which the trial court denied. After Honeywell rested, plaintiffs sought and obtained a directed verdict on Honeywell’s claim that the verdict form should include third parties such as Honda and Honda and Borg-Warner as outlined by the Florida Supreme Court in Fabre v. Marin. The jury awarded plaintiffs over $24 million in damages which included $10.4 million for Guilder’s children for loss of parental consortium.

First, the appellate court addressed the letter written by a Bendix employee. Although the appellate court stated that the letter was relevant to proving Honeywell’s knowledge of the dangers of asbestos in its products, the appellate court agreed with Honeywell that the portion which stated, “My answer to the problem is: if you have enjoyed a good life while working with asbestos products why not die from it. There’s got to be some cause[,]” was unfairly prejudicial and the trial court erred by refusing to redact that portion.

Second, the appellate court mentioned that the Florida Supreme Court in Fabre v. Marin, stated that “the legislature intended that damages be apportioned among all participants to the accident” and that “the only means of determining a party’s percentage of fault is to compare that all of the other entities who contributed to the accident, regardless of whether they could have been joined as defendants.” Because Honeywell pleaded the fault of non-parties and presented sufficient evidence regarding two non-parties, the appellate court found that Honeywell satisfied Fabre, and was entitled to have those non-parties listed on the verdict form for apportionment of liability.

Next, the appellate court addressed the award of parental consortium damages. By statute, Florida provides for loss of parental consortium for “acts of negligence occurring on or after” the statute’s effective date of October 1, 1988. The appellate court held that the negligent act was Guilder’s last known exposure to asbestos which occurred in 1982. Because those acts were before the effective date of the parental consortium statute, the appellate court found that the loss of consortium damage award was improper.

Finally, the appellate court addressed whether Honeywell was entitled to an set-off for $2,820,000 in settlements the plaintiffs received. The appellate court held that the trial court erred by failing to set-off the settlement proceeds from the verdict before entering final judgment.

The appellate court reversed the final judgment and remanded for a new trial.  Honeywell International, Inc. v. Guilder.

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Neither a Product Nor a Premise Claim Says Texas Silica MDL Court

Yesterday, the Texas Silica MDL Court granted a defendant’s no evidence summary judgment motion in a case in which the plaintiff alleged that pipes specified by the defendant to be sandblasted offsite and thereafter installed on its premises were either defective products or somehow an extension of the defendant’s premises over which it retained and exercised control. Plaintiff had sandblasted the pipes but had never actually worked at defendant’s facility. He was subsequently diagnosed with silicosis and “silica related lupus”.

Plaintiff claimed that the defendant’s specifications for a particular surface finish on the pipes, which plaintiff argued could only be achieved by using high silica containing flint or other abrasive, meant that the defendant exercised enough control over the manner of plaintiff’s work that it could be held liable for his injury. The defendant argued that there was no legal duty to the plaintiff and that there was no control that would give rise to Chapter 95 liability.

The Texas MDL court rejected plaintiff’s attempt to use premise liability theories to maintain product liability or negligence claims when there was no product created, manufactured or sold by the defendant and none of the acts allegedly responsible for his injuries occurred on the defendant’s premises. Plaintiff had admitted that there was no Texas case law to support his theory.
 

An Anniversary to Remember

Forty years ago Clarence Borel, dying of mesothelioma, filed his landmark claim against the leading manufacturers of asbestos products.  Borel prevailed at trial and when the defendants appealed his $75,000 judgment saying he couldn't prove which defendant was responsible the 5th Circuit open the floodgates of mass toxic tort litigation by holding:  

“[I]t is impossible …to determine with absolute certainty which particular exposure to asbestos dust resulted in injury...” “[E]ach exposure may result in an additional and separate injury…. therefore … the jury could find that each defendant was the cause in fact of some injury…”

5th Circuit Rules Landowners Have Standing for Claims Related to Oil Companies' Greenhouse Gases

Hurricane Katrina came and went but the landowners class action claims for damages caused by oil companies' greenhouse gases are still standing. On October 16, 2009, the Fifth Circuit Court of Appeals in Comer v. Murphy Oil held that plaintiff landowners had standing to assert causes of action for negligence, private and public nuisance, and trespass against oil companies for their release of greenhouse gases, which caused rising sea levels and increased the ferocity of Hurricane Katrina. In reversing the district court's dismissal of the property damage claims, the court ruled that plaintiffs’ Mississippi tort common law claims met the state’s liberal standing requirements, but also the federal standing requirements because their alleged injury could be traced to defendants’ greenhouse gas contributions. The U.S. Supreme Court’s decision in Massachusetts v. EPA played a critical role in the court’s analysis of the standing issue. The court also held that these claims did not present nonjusticiable political questions. While the standing issue is the beginning and not the end of how much liability, if any, the oil companies have for damages resulting from greenhouse gases in this case. This decision may signal the beginning of the expansion of liability for damages directly, or indirectly, related to a person, company or industry’s contributions of greenhouse gases.

How will the Second Court of Appeals Interpret Borg-Warner?

The oral argument in Rosemary Smith, et al v. Kelly-Moore Paint Company that took place October 15, 2009 before the Second Court of Appeals can be heard here.  The plaintiff appellant is asking the appellate court to hold that Borg-Warner v. Flores does not apply in a mesothelioma case because, they claim, there is "no safe level" for exposure to asbestos and because even minute exposures have been declared to be causative.  Accordingly they ask that in mesothelioma cases plaintiffs be excused from having to demonstrate quantatively the dose given by any particular defendants' product, premise, etc.

We’ll let you know when Second Court of Appeals reaches its decision.
 

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Subsequent Application of Asbestos: Whose Duty to Warn?

In Merrill v. Leslie Control, Inc., a California appellate court reversed and set aside a verdict in favor of plaintiffs and held that a defendant “owed no duty to warn against dangers in products, used in association with or as replacement parts of its valves, which it did not manufacture or supply.”

Richard Merrill filed suit for his mesothelioma that was allegedly caused by exposed to asbestos during his service in the Navy. The jury found that Leslie Controls valves were defective because it failed to warn of potential risks, the valves were defectively designed, and Leslie Controls was negligent.

Merrill had worked on Leslie Control valves that were used on ships on which he served. The valves had asbestos-containing internal gaskets which Leslie Controls did not manufacture. Leslie Controls instructed purchasers of its valves to insulate around its valves but it did not provide insulation and its field engineers were aware that asbestos insulation was applied to and removed from its valves and were even present when it was done. Leslie Controls also provided manuals for their valves and was aware that packing would be removed or added during maintenance and the manuals contained no warning of the dangers of asbestos.

The appellate court found that there was no evidence that Leslie Controls manufactured or supplied any asbestos-containing internal packing and gaskets to which Merrill was exposed, it did not manufacture or supply gaskets attached to the exterior of its valves, and it did not supply or manufacture asbestos-containing insulation used around the valves. Thus the appellate court held that Leslie Controls was not liable in strict liability “for failing to warn of hazards associated with the handling of these products.”

The Court stated that a manufacturer’s duty to warn is limited to its own products. The court also rejected liability premised on the component parts doctrine because Merrill could not provide evidence he removed the old internal packing that had been supplied by Leslie Controls in the valves.

Continue Reading...

1st Court of Appeals Decides Union Carbide v. Smith

In a decision significant for its discussion of Texas’ Chapter 95 premises liability scheme the 1st Court of Appeals today reversed a $4+ million judgment against Union Carbide and Hexion arising out of a mesothelioma case tried to verdict in Galveston and rendered a take nothing judgment in favor of both defendants.

Essentially the court held that there was no evidence of control sufficient to support a verdict against Union Carbide. Providing asbestos-containing gaskets to the plaintiff contractor was not control – especially as any asbestos exposure arose out of the manner in which he used them rather than any intrinsic property. Specifying asbestos-containing insulation be applied by other contractors was not control, employing other contractors who stirred up dust was not control and requiring and holding mandatory safety meetings for plaintiff’s supervisors was not control.

Interestingly however, on page 9 at footnote 7, the court spends considerable time discussing a jury question the plaintiff didn’t request that would have led to a jury considering whether a premises owner exercised control over some other contractor, such as an insulator, which in turn led to the plaintiff’s exposure. There’s clearly a hint here that the court doesn’t think the control inquiry is limited to whether premises owner exercised control over the manner in which plaintiff did his work but extends to whether the premises owner controlled the manner of the work of some other contractor who in turn injured the plaintiff. But the plaintiff didn’t ask for the question so too bad.

Regarding the claims against Hexion, the plaintiff’s employer, they appear not to have been the usual Article 16 Section 26 workers’ comp avoiding effort we typically see in Texas. Instead the plaintiffs appear to have latched on to the idea that Hexion was not actually the plaintiff’s employer during that period of time during which plaintiff worked for Hexion’s predecessor so that the comp act’s bar to common law claims against employers for on the job injuries wouldn’t apply. The court basically held that public policy argued for an expansive view of worker’s comp coverage. The plaintiff made a last ditch plea to have the court adopt the “dual persona” doctrine, which would have separated Hexion into with and without coverage entities. Noting that no Texas court has ever done so as a means for imposing liability on a covered employer otherwise immune to suit the court declined the invitation.

... the Obama administration may view lawsuits as helpful to its work...

Private lawsuits to advance changes being sought by the executive branch? Undoubtedly the plaintiff bar is saying "Yes we can!"

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Borg-Warner: Sufficient Cause or Significant Risk?

Williams Kherkher has filed their brief in Bailess v. Kaiser Gysum Company, Inc., et al. on appeal from the MDL court's granting of a summary judgment against their mesothelioma client.  According to the brief at the hearing on the motion for summary judgment the court stated that its ruling would be determined as follows:

This motion is going to be decided straight up on what Borg-Warner says and what Borg-Warner requires... If Borg-Warner requires that the dose from each defendant be enough by itself to be the substantial contributing factor, the motion must be granted.  If Borg-Warner does not require that, then the motion must be denied...

Having granted summary judgment the MDL court apparently settled on the former rather than the latter intrepretation of Borg-Warner.  In my opinion the premise doesn't reflect the true meaning of Borg-Warner.

Texas case law has refined and melded concepts of causality and culpability into a coherent and flexible scheme for determining whether or not liability ought to be imposed for the adverse consequences (negative externalities) of our actions. Essentially, a substantial contributing factor is a "but for" cause resulting from a risk imposed that was more than de minimis. The word "substantial" in "substantial contributing factor" relates, I think, to risk since any candidate cause must we know from Ford v. Ledesma be a "but for" cause and thus no more or less important than any other "but for" cause since without it, or any other such cause, the plaintiff would not have been injured.

The Bailess ruling then appears to impose a requirement that any candidate cause must be shown by plaintiff to be a sufficient cause - in other words, a cause which in and of itself, and without resort to other causes, would have brought about the plaintiff's injury. If so, this change would mark a dramatic shift in our law since in toxic tort cases, as well as in just about any other non-intentional tort case, plaintiff has always been able to recover despite the fact that her injury would not have occurred but for the actions of each of two or more tortfeasors; tortfeasors whose actions were necessary causes but not sufficient causes.  For a good discussion of the difference between sufficient cause and component "but for" causes which collectively produced the injury, see:  www.defendingscience.org/upload/Rothman-Greenland.pdf

I don't think that's where Texas case law is heading.  The question raised by Borg-Warner in a mesothelioma case is not "was defendant's asbestos a cause and if so how big a cause was it" but rather "was the exposure (i.e. the risk) from defendant's product substantial"? In other words, was the risk imposed by defendant's conduct so substantial that it can justly form the basis for liability assuming that it can never be determined which fiber or groups of fibers actually caused the plaintiff's cancer?

Dyspepsia Time for Texas Trial Lawyers?

In Bennett et al. v. Reynolds, No. 08-0074, Tex. 2009.  (Opinion of Court of Appeals, 242 S.W.3d 866), a wonderful only-in-Texas cattle rustling claim, the Texas Supreme Court has granted  defendant's/appellant's petition for review.  While actual damages awarded were only $5,327.11  the punitive damages came to $1,250,000.00.  Among the four issues the court will consider, mass tort lawyers will be most interested in the first two:

1. Was the evidence of malice legally insufficient to warrant punitive damages when the cattle
raiser merely sold some cattle that were not his, but did not cause or threaten “death, grievous
physical injury, or financial ruin”?

2. Is the $1.25 million punitive damages award—which is 235 times the compensatory damages
awarded—within the limits allowed by constitutional due process?

Stay tuned as this case has been set for oral argument on December 15, 2009.

Follow the Money

If an analysis of the most recent list of Google Adsense's highest paying search terms as compiled by CyberWyre is any indication of what the future holds, and where the money is, then I'm guessing it has something to do with mesothelioma.  The top two highest paying search terms are "mesothelioma treatment options" at $69.10/click and "mesothelioma risk" at $66.46/click.

Of the top twenty-five highest paying search terms, eighteen contain the word mesothelioma.   A number of the most expensive search phrases related to mesothelioma also contain words like "treatment", "doctor", "prognosis", "chemotherapy" and "cure".  An unscientific sampling of the results of such searches appears to generate far more links to lawyers than to physicians.  Go figure.