Mass Torts: State of the Art : Mass Torts Lawyer & Attorney : Vorys, Sater, Seymour & Pease Law Firm : Toxic Torts & Wrongful Death

While some people still mock the idea that bacteria have abilities far beyond anything imagined and thus impact our lives in almost unbelievable ways the evidence that it is so continues to mount. Take for example today's article in the NYTimes titled "Bacteria Divide People Into 3 Types, Scientists Say". Apparently we tend to be colonized (interesting word choice for a host (no irony intended) of reasons) not by more or less of certain types from a spectrum of bugs but rather by one of three sorts of microbe societies. One can imagine the speed dating possibilities: "I'm a Bacteroides; what are you? "Oh, we can end this now. I'm a Prevotella and I just can't deal with all the Bacteroides drama." See "Enterotypes of the Human Gut Microbiome"

The authors liken the discovery of consistent patterns of bacterial colonization to blood typing. I'll bet it's far more profound than that. All Hail our Bacteroides Overlords! All kidding (I hope) aside, I was convinced last year when my son and I as part of a 5th grade science project quite inadvertently happened upon the micro-droplets on the underside of a cover slide past which we'd been watching some beasties from a puddle. In the droplet were bacteria zipping about plus a couple more that had lined up and started to push out of their little bubble of existence. Over time they organized themselves into a straight line and kept pushing outward until they reached a bigger drop whereupon the survivors of the small droplet passed through the tiny tunnel their fellows had made and escaped. Simply amazing.

Also we're learning that all bacterial infections are not created equal. In recent years parents of children with type 1 diabetes have had to wonder about whether they might accidentally have caused the illness by creating too sterile an environment. That's because of mounting evidence that children exposed to dirt and thus microbes have a lower incidence of type I diabetes - more evidence for the hygiene hypothesis. Now however come some new studies showing that simply being exposed to lots of bacteria isn't enough to help ward off type I diabetes. For example see "The Incidence of Type-1 diabetes in NOD (non-obese diabetic) Mice Is Modulated by Restricted Flora Not Germ-Free Conditions". Germ-free (gnotobiotic) mice are no more prone to type 1 diabetes than their germy cousins unless their cousins had a very particular sort of infection by B. cereus (most recently of not-so-sterile hospital wipe fame).

So what does it all mean? Nobody who's honest really knows. Beads and rattles, after all.

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Start with "Medical Errors in the USA: Human or Systemic", head over to Health Policy Brief: Improving Quality and Safety (04/15/2011) and then try  "'Global Trigger Tool' Shows That Adverse Events in Hospitals May Be Ten Times Greater Than Previously Measured". It reminded me of my Great Grandmother who had a serious stroke yet refused to go to the hospital: "You don't ever want to go to the hospital; if you're lucky you come out no worse off than when you went in." Instead she called for big cans of soup from her pantry to use as workout weights to help get her strength back. Ten years later she was given too much of the wrong medication and died soon after. But 102 ain't a bad bad age to make it to especially if you're independent to (almost) the very end.

Finally, ponder "Should the Practice of Medicine be a Deontological or Utilitarian Enterprise?" Maybe our problem here too in the states is that we're stuck with a promise of heroic effort in every case yet able, obviously, to deliver only the effort that knowledge, time and money allow. So instead we make a big production of hospitalization and in the process gather a mountain of analytical test data that can't possibly be adequately analyzed (in no small part because we don't know what most of it means). In the meantime we subject patients to a staggering numbers of unnecessary tests or pointless biopsies and expose them to all the attendant risks including nosocomial infections.

So for now, and for the foreseeable future unless we're willing to admit that medicine knows a whole lot less than it claims, we'll have to settle for beads and rattles.

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This month's Journal of Occupational and Environmental Hygiene has several interesting articles. If you're looking for confirmation of the worry that expert subjective or quasi-quantitative (e.g. task based) exposure estimation techniques don't produce anything that has much to do with reality see:

"Evaluation and Comparison of Three Exposure Assessment Techniques"

If you want an estimate of benzene exposure above 1 ppm from mineral spirits containing less than 0.1% benzene wt/wt see:

"Estimating Airborne Benzene Exposures from Air Monitoring Data for Mineral Spirits"

If you wonder why historical data on asbestos exposures from joint compound don't jibe with data from recent efforts to measure exposures using recreated asbestos-containing joint compound from old formulae see:

"Potential Artifacts Associated with Historical Preparation of Joint Compound Samples and Reported Airborne Asbestos Concentrations."

Finally, if you want to know what variables influence dust in the breating zone of drywall sanders see:

"Factors Influeincing Dust Exposure: Finishing Activities in Drywall Construction"

Always remember, what you see depends on how you look as much as where you look. 

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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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When considering how legal outcomes may affect beliefs (think experts opining on general causation in the face of a lack of science), it is interesting to consider not just science but pure belief.

A beer joint in a small Texas town built an addition. A congregation prayed that it not be built. Lightning struck. The church rejoiced, firm in the belief of the power of prayer. The bar owner sued the church for causing, directly or indirectly, the lightning strike which smote his expansion. The church then denied the power of prayer. No really. True story.

Let’s again consider general causation and the power of process of elimination causation determinations.
 

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Though it starts out as a discussion of the Collegium Ramazzini's call for "a global ban on asbestos" the interview with Dr. Lemen in this month's EHP quickly turns to new frontiers in the litigation (e.g. ovarian cancer), the nefarious impact of profits on corporations (and not individuals, apparently) , the implication that chrysotile is worse than amphibole asbestos, and an argument that we already know everything we need to know about asbestos and so shouldn't waste any more "research dollars" on studying the issue.

Read about it here or listen to the Podcast .

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The recent Milward opinion out of the U.S. First Circuit Court of Appeals notwithstanding, the subjective assessment of an expert, weighing whatever evidence he selects for consideration in the scales of his own "scientific judgment", is not how causal inferences should be reached. At least not according to the National Academy of Sciences (NAS).

Last Friday NAS released its report on EPA's Integrated Risk Information System (IRIS) assessment of formaldehyde. It wasn't impressed with the overlong and detailed discussions of each study the EPA had considered. Rather, it expressed its concern that all EPA had at the end of the day was a pile of studies and its scientific judgment. Specifically the NAS reiterated, as it has in the past, that data + a statement that proper methods of causal inference had been followed ≠ sound science.

Of the criticisms leveled against the EPA's report the most frequent was for a lack of transparency. The EPA hadn't made it at all clear how it was going to go about assembling data, how it was going to assess the data, by what criteria it would include or exclude a given piece of data or how, and by what standards, it was going to weigh the data it found worthy of consideration. How can another scientist assess the soundness of an expert's conclusion if she has nothing other than "I considered the following studies and reached the following conclusion using my best judgment" to go on? She can't.

So on page 115 the NAS reviews best practices for conducting and assessing comprehensive reviews. If you're dealing with an expert who says "I used the A.B. Hill criteria and my scientific judgment to reach my opinions" you'll find the discussion that follows full of great cross examination material. Where, for example, is the evidence table prepared by the expert? What weight does he assign to each datum? How did he come by it? If a particular study has a potential for bias by how much did he lessen the weight assigned, how did he come up with the number and in what other matter has he used the same modifier to account for possible bias?

Finally, the NAS took a particularly dim view of the EPA's conclusion that formaldehyde likely causes all lymphohematopoietic (LHP) cancers. (See pages 80 - 87). There's "[t]he grouping of 'all LHP cancers' includes at least 14 biologically distinct diagnoses in humans and should not be used in determinations of causality". And "there is no clearly articulated framework for establishing causation on the basis of the weight and strength of evidence". Finally "the conclusion of causation appears to be based on a subjective view of the overall data ... [t]he absence of a causation framework is especially problematic for the individual LHP cancers, given the highly variable epidemiologic literature and the high uncertainty of mode of action."

Bottom line: if you're going to use a "weight of the evidence" approach you have to say how you decided what to weigh and by what standards you weighed it. Pretty basic stuff really.

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Systematic reviews and meta-analyses are considered to be perhaps the best evidence about treatments/exposures and outcomes from which causal inferences can be drawn. The problem is that they're susceptible to a variety of biases. See e.g. "Bias Due to Changes in Specified Outcomes During the Systematic Review Process".

In the litigation context we increasingly see a systematic review launched by an expert-to-be before the first suit is even filed.  They will thus have already gone through the studies; used their "judgment" to select which ones ought to be considered (and which ought not); determined how much weight to give each; and established a protocol for conducting the review which, surprise surprise, demonstrates a causal link supporting the lawsuits. The strong suspicion is that selection bias (a form of the Texas Sharpshooter effect) is at work (and that, of course, is being charitable). And the biggest problem is that uncovering selection bias is notoriously difficult.

Now there's a move afoot to bring transparency to systematic reviews by requiring that plans, methods and protocols be registered before the systematic review is begun. See "Best Practice in Systematic Reviews: The Importance of Protocols and Registration"; "New Initiative to Make Systematic Review Protocols More Transparent"  and "Open Medicine Endorses PROSPERO". Here's the press release from the Cochrane Collaboration and here's a link to PROSPERO.

Until we get courts to make experts disclose their methods and justifications for selecting, weighing and interpreting data before they develop their opinions articles like the following may come in handy: "How Can We Improve the Interpretation of Systematic Reviews?"

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Following the anthrax attack after 9/11 someone I knew began keeping a bottle of Cipro on his desk. He went through it that week. Had his family on it too - more bottles at home. I distinctly remember him telling me that I really needed to get to be buds with a doctor so I could get the good stuff. I worried that I'd put my family at risk by not developing a dealer. Of course I'd never really thought about it before because I had another friend who had always had several Z-paks in her top drawer. "I just call and say I've got a fever and a red throat and he writes me a 'script'." She mainly got them for her mother because her Mom's doctor wouldn't ever give her anything; "he always just says 'it's a virus'."

Now that we have relearned that many bacteria and fungi are keen on killing us and feasting on our corpses shouldn't we be keeping our powder dry? And now that we're learning almost daily of new microscopic bugs suspected of causing cancer (See e.g. "Novel Clues on the Specific Association of Streptococcus gallolyticus subspecies gallolyticus With Colorectal Cancer") shouldn't we hold off on using antibiotics until we see the whites of their colonies cultured in a petri dish lest we make them immune to what few weapons we have?

Read all about it at the WHO's "Combat Drug Resistance" webpage.

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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.

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Last week I deposed yet another expert witness who based his opinion on the so-called methodology of "process of elimination"; sometimes referred to as "differential diagnosis". Apparently, the new fad in Daubert-avoidance is to claim that one's opinion was reached via this unassailable method since he's the fourth expert in a row to so claim. Too many judges, all having run the gauntlet of SATs and LSATs, tend to find the method sound and unexceptional. So for them, here's a test.

What is the most likely cause of plaintiff's cancer? (A) "the evil eye"; (B) "bad humours of the blood"; (C) a Voodoo curse; (D) demonic possession; or, (E) Tetra-methyl-whatchamacallit?

Next, say why.

Expert witnesses who play the "process of elimination" game want you to assume, as good high school students do, that the set of all possibly correct answers is encompassed by choices (A) - (E). Of course, not all possible answers are known in real life and seldom do experts present viable alternatives to (E). Nor do they ever, out of fear of all things Bayesian, attempt to lay odds on the theory nor even say by how much subsequent evidence has affected their confidence in the proffered theory.

Our job often then is to explain to the courts that the other side's expert opinion (E) is not the result of considering evidence for and against (E) but is rather a form of the argument to ignorance. Real claims to knowledge still require evidence and the statement that a hypothesis is probably true because the straw men put up to oppose it are unconvincing is an absurdity. Hypotheses will always stand or fall on the evidentiary foundations upon which they themselves rest rather than upon the foundations of competing ideas.

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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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In a retrospective autopsy review of 2,025 available autopsies performed before 1910 no cases of malignant mesothelioma were detected. See "Rarity of Malignant Mesothelioma Prior to the Widespread Commercial Introduction of Asbestos: The Mount Sinai Autopsy Experience 1883-1910".

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Recent attempts to lay pretty much any cardiovascular or pulmonary malady at the feet of fine particulate matter got a boost with JAMA's publication this month of the commentary "Air Pollution as an Emerging Global Risk Factor for Stroke". But what happens when you actually monitor the air for PM2.5 and then compare the levels found to the rate of ischemic stroke? If there's an association you'd think rising levels of PM2.5 would be followed by an increase in ischemic stroke. "Fine Particulate Air Pollution (PM2.5) and the Risk of Acute Ischemic Stroke" found no support for such an association (though it should be noted that an increase was detected among one subgroup: diabetics)

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