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

How do people's memories of pesticide exposures correlate with industrial hygiene estimates of those exposures? Not so well. In fact it's pretty clear that a lot of people with Parkinson's assume that chemicals caused their illness and so are primed to remember past high exposures that had not in fact occurred. For a well done paper showing no association between pesticides and Parkinson's plus a great discussion of recall bias see: "Pesticide Exposure and Risk of Parkinson's Disease - A Population-Based Case-Control Study Evaluating the Potential for Recall Bias".

Those looking for the real cause of the increase in risk of Parkinson's among those involved in farming should pay attention to the endotoxin discussion. I'll check the studies that show endotoxin may protect against lung cancer in cotton textile workers to see if there's any hint of a Parkinson's excess and report back.

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There's a growing body of evidence pointing to early disruption of gut microbiota via antibiotics as a cause of inflammatory bowel disease and Crohn's disease later in life. For the newest see "Association Between the Use of Antibiotics in the First Year of Life and Pediatric Inflammatory Bowel Disease" in this month's American Journal of Gastroenterology.

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So what are the myelodysplastic syndrome (MDS) risk factors du jour? Treatment for tuberculosis, benzene, "new building and renovation", pesticides, hair dyes, traditional Chinese medicines (for one subtype of MDS), gasoline and herbicides. Education was somehow protective. See "Case-Control Study of Risk Factors of Myelodysplastic Syndromes According to World Health Organization Classification in a Chinese Population" published in the Feb. 2011 American Journal of Hematology.

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I thought it was no biggie when the FDA sent out an email late Wednesday morning saying that an extraordinarily rare malignancy, anaplastic large cell lymphoma (ACLC), had been associated with breast implants. A variety of implants, mainly orthopedic devices, have long been associated with certain rare cancers. Since the site of the cancer tends to coincide with the site of complicating surgical infections it has been thought that an infectious agent was responsible. See e.g. "Soft Tissue Anaplastic Large T-Cell Lymphoma Associated With a Metallic Orthopedic Implant: Case Report and Review of the Current Literature".

A quick review of PubMed showed that concern over ACLC and breast implants had been around for years. See e.g. "Anaplastic Large-Cell Lymphoma in Women With Breast Implants" (free in JAMA) published in 2008. So I went looking for something else to post on. Then, on tonight's 10 o'clock news here in Houston, one of the local stations led off with a story about the late John O'Quinn's litigation against Dow Corning and his claims that silicone implants caused autoimmune disorders and cancer. They made it sound as though O'Quinn had had somehow been vindicated by today's FDA press release. Then they went out and found some sympathetic woman who had recently had a radical mastectomy followed by breast reconstruction and asked her what she thought about the "new report on breast implants and cancer". To her everlasting credit she said she was happy with her decision and was confident that she'd made the right one.

ACLC is not breast cancer and the odds of getting it, assuming the association is confirmed (and there is indeed an awful lot of evidence showing that in the areas around implants whether silicone or metal where infections can set in, cancers can sometimes follow) are about 1 in 900,000. The odds by the way of drowning in your bathtub are significantly higher - somewhere around 1 in 660,000.

The media could have focused on the story of the mounting evidence for a link between pathogens and cancer. Instead they seem to have resorted to a long since discredited narrative about breast implants. It's too bad because the real story is the story of our generation.

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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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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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The British Medical Journal has just published an editorial titled "Assuring Research Integrity in the Wake of Wakefield" that addresses what has finally been revealed to have been an elaborate fraud concocted by a scientist and some personal injury lawyers in an effort to launch a mass tort. Unfortunately, rather than addressing the real problem (which is that the majority of the published peer-reviewed papers purporting to find an association between some drug or exposure or gene and a disease are probably false) the authors of the editorial reference a handful of ethical lapses spaced about twenty years apart and ask "[h]ow could this happen again?"; implying rather obviously that scientific fraud is almost as rare as Piltdown Man but nonetheless something about which the academy ought to be vigilant lest the public lose faith in "science".

They conclude with "We must transcend traditional hierarchies and authority gradients to empower everyone in the research enterprise ... to raise questions and "stop the line". I've no idea what the first part means though it sounds suspiciously like something out of "Transgressing the Boundaries: Towards a Transformative Hermeneutics of Quantum Gravity". The latter part on the other hand, quite inadvertently I assume, manages to expose the real problem with today's "research enterprise". It refers to the ability of factory workers on an automobile assembly line to halt the process when they detect a problem rather than having to wait until a supervisor calls for a stop. Focus then on the idea that many "researchers" aren't involved in the process of discovery or even design. Rather their part is played down on the assembly line of the Science factory - manufacturing the same sort of science; shift after shift, day after day, year after year. Their job is to identify anything that might throw a wrench in the works or cause the product to be defective and thus rejected by the customer, typically the government, industry or an NGO, to repair or engineer around it and to keep the line running.

The authors' concern then is with the process and not the product. But of course, if you've been paying attention, you know by now that the product is the real problem. In studies like Wakefield's, in which statistics are trotted out to test hypotheses, the "science" is probably wrong even if the researcher isn't consciously cooking the books in order to gin up a mass tort. Read and re-read "Odds Are, It's Wrong" from ScienceNews. Let the following quote sink in: "There is increasing concern that in modern research, false findings may be the majority or even the vast majority of published research claims."

Whether or not the product of the Science factory is worth its price or indeed worth anything at all, it keeps on coming in an ever increasing torrent.  Take for example genome-wide association studies (GWAS) - one of the most notorious examples of  too often useless "research" produced assembly line style. (Note there are efforts to improve it. See e.g. "A Knowledge-Based Weighting Framework to Boost the Power of Genome-Wide Association Studies") A quick search of PubMed reveals that 45 new genome wide association studies have rolled off the line in just the last week. That's great news if you're in the business of selling SNP chips to research universities and a sign of a boom (or bubble) in the fortune of researchers. And maybe it's even good for the economy - being after all a form of digging holes and filling them back in. But where does it end?

Ponder the following from "The Future of the Research University" written in 1997: "We need to think seriously, within the community of research universities, about whether we are producing too many Ph.Ds. This is a controversial question, with different answers in different scholarly disciplines, but the general conclusion seems inescapable: The mathematidcs of exponential growth - each professor producing numerous Ph.Ds who become professors who produce numerous Ph.Ds, etc. - has caught up with us."

With that exponential growth in Ph.Ds desperate for something to research and something to publish it's no wonder that so many turn to statistical tools which, when rigorously and repeatedly applied to any mound of data, will inevitably produce a publishable statistically significant, though often false, result. And despite concern that the exponential growth in the number of Ph.Ds "has caught up with us" there's no sign that the factory is cutting back on the number of shifts. Instead, more factories are being built. Indeed what got me thinking about this was a huge billboard on I-45 announcing that what was once the humble but excellent Teachers' College is now itself a Research University! Sure enough, a stroll through their website reveals that they've bought a great pile of extremely expensive analytical equipment and will soon be adding to the mountain of Science being manufactured. Everybody it sometimes seems is getting in on the "research enterprise".

The point then is that research has become an industry; and an enormous one at that. Best then to stay as skeptical of Big Research and Big Research Publication (note the circle the wagons approach of the Lancet's editorial board when they first got whiff of the fraud) as you are of Big Corporation. And best then as well to train your attention on the product of factory Science even if the process by which it was made is sound. Remember, it's generally not enough to say simply that it was made According to Plan.

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Here's a small study (1704 workers) of people exposed to "perc" (perchloroethylene a/k/a tetrachloroethylene): "Mortality and End-Stage Renal Disease Incidence Among Dry Cleaning Workers". Small increases in the overall risk of dying from cancer of any kind and from esophageal, lung and tongue cancers in particular were identified. Most significant was a near doubling of the risk of developing end-stage renal disease. As risk appeared to rise with increasing duration of employment (a proxy for exposure) at least for some of the cancers it was concluded that perc, rather than lifestyle or socioeconomic factors, was responsible and that it's therefore likely a human carcinogen.

Yet just last October a study of 10,389 Swedish dry-cleaning and laundry workers (the largest yet of perc-exposed workers) found no increase in cancer risk either overall or for those sorts of cancers thought possibly related to perc exposure. The article, which is free, has a great discussion of the perc controversy, the various positions taken by IARC, the NTP, the ACGIH and others, and a brief discussion about why the healthy worker effect might not be an issue in occupational cancer inquiries. It was published in the International Archives of Occupational and Environmental Health as "Cancer Morbidity in Swedish Dry-Cleaners and Laundry Workers History: Historically Prospective Cohort Study".

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In epidemiology, whenever lower incidence and lower rates of mortality from cancer occurs in a population commonly assumed to be at risk cognitive dissonance is always lurking. What generally happens is that the good news is shrugged off as "the healthy worker effect" and epidemiologists resolve to re-sift the data in order "to get the right answers". The "right answers" of course are often only those that support our preconceptions.

That means there aren't many people willing to even consider the possibility that working in a chemical plant or going off to war or spending a career mining / processing uranium while being exposed to low levels of gamma radiation might actually confer a health benefit. Nevertheless, the so-called healthy worker effect (which is called the healthy warrior effect for those who served in the armed forces) appears so commonly and across so many trades that you have to wonder if something besides simply screening employees for good health is at work. If you're interested here are three studies worth pondering.

In this month's journal of Occupational Medicine you'll find an excellent discussion in "The Healthy Worker Effect in US Chemical Industry Workers". The study was of thousands of Dow Chemical employees - three million years worth of employment combined. The overall risk of death from any cause was lower than expected as was the risk of dying from nine types of cancer thought to be related to smoking. Nevertheless the authors, an epidemiological team working for the Dow Chemical Company, concluded that the findings were likely due to the healthy worker effect though with a caveat. Some have suggested that the healthy worker effect arises because employers dismiss employees with health problems. However, in this study the health outcomes of those employed for a decade or more were the same as those who didn't last very long with the company. The finding thus suggests that the presumed healthy worker effect was generated as each employee was considered for employment such that workers destined to get cancer decades later somehow were never hired in the first place making it in fact a "healthy hire effect".

For another example see "Psychiatric Diagnoses in Historic and Contemporary Military Cohorts: Combat Deployment and the Healthy Warrior Effect". Despite some claims in the media that might make one assume otherwise those who serve in the military see lower than expected numbers of ailments including psychological ones. Here the suggestion is that those prone to psychological illness  are screened out as what risk there was of developing psychological issues after combat was concentrated in those with preexisting mental health issues.

Finally, published last month in the journal Radiation Research, there's "Mortality (1950 - 1999) and Cancer Incidence (1969 - 1999) in the Cohort of Eldorado Uranium Workers". With the exception of lung cancer incidence and mortality which demonstrated a small increase in risk, the Eldorado uranium miners managed to have significantly lower risks of dying from any cause, lower risks of dying from all cancers combined (lung cancer included) and a lower risk of developing any type of cancer cumulatively (lung cancer again included).

Now be honest. If someone had asked you yesterday whether you'd pick (A) uranium workers, or (B) the average Canadian male, as the group likely to have a much larger risk of getting cancer and of dying of cancer which would you have chosen?

So what's at work here? Is it simply that those prone to developing cancer in the distant future are somehow weeded out and never hired in the first place? Or does it perhaps have something to do with the nature of blue collar employment over the last 50 years? To me it all looks a lot like the compliance effect - the phenomenon whereby e.g. those who lead very ordered and structured lives and who thus always take their placebo at the appointed time manage not only to do better than those less disciplined and also on a placebo but oftentimes better even than those less disciplined but at least irregularly taking real medication. So I'll go out on a limb and guess that the claims of toxic tort plaintiffs notwithstanding, large employers engaged in manufacturing not only didn't shorten the lives of their workers they lengthened them by imposing the very order and rigidity about which so many bitterly complain in their depositions.

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Human papillomavirus, or HPV, is well established as a cause of cervical cancer. Now it's thought that the infection causes even more cases of head and neck as well as anogenital cancers. For the newest on HPV and cancer see:  "Impact of HPV on Oropharyngeal Cancer". Obviously prevention is important and new vaccines appear to be safe and effective ("Efficacy and Safety of Prophylactic Vaccines against Cervical HPV Infection and Diseases among Women: A Systematic Review and Meta-Analysis") but what to do about the millions already infected? For some thinking along those lines see: "Human Papillomaviruses As Therapeutic Targets in Human Cancer". 

Also of interest is a new discussion of the evidence for the proposition that male circumcision protects women from cervical cancer in "Male Circumcision and HPV Transmission to Female Partners". Combine such rediscoveries with the "Oops, sorry" reaction of those, including the WHO, who had recommended that infants be breast fed exclusively for six months (and who now must eat humble pie in light of studies showing that such advice, if followed, likely leads to food allergies or worse) and perhaps it's time for a new approach to activist-led health initiatives that seek to upend traditional practices. Since activists can't be made to pay for the injuries they cause (mass tort litigation generally being a search for deep pockets rather than truth) maybe we should at least require that any demand for an extraordinary change in traditional practices be backed up by extraordinary evidence.

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Last October some scientists got together in San Antonio to discuss the potential hazards of flame retardants. They wound up signing the "San Antonio Statement on Brominated and Chlorinated Flame Retardants" co-authored by Ake Bergman. Their claim is that the flame retardants are bio-persistent, toxic (especially when burned), cause neurological development in children and, because of their use in electronics including housings, being effectively dumped in third world countries where the products are recycled.

Bergman was interviewed for The Researcher's Perspective and you can read or listen to the interview at EHP in "The San Antonio Statement, with Ake Bergman". Bergman is quoted as saying of flame retardants "they are acting in a similar way than [sic] the other chlorinated compounds are, which is leading to a number of effects - for example, cancer risks; endocrine-disrupting properties of the chemicals, we have reproductive effects of the chemicals; and not the least, the neurodevelopmental effects that they cause, and for the neurodevelopmental we are talking about young children, the newborns, being affected." He goes on to say that he hopes that five years hence such flame retardants will all be banned and he says that "it's ridiculous to learn that you have nursing pillows with flame retardants..." Pity the poor maker of nursing pillows. A dropped cigarette or a pillow set too close to a space heater and woe be to the manufacturer who made it of cotton and didn't soak it in flame retardants.

Anyway, what should we make of the claim of neurodevelopmental effects? Well, as fate, or luck, would have it Dr Bergman has just co-authored a newly published study titled "Polybrominated Diphenyl Ethers in Relation to Autism and Developmental Delay: A Case-Control Study". The data from the study show that there is no relationship between PBDEs (the flame retardants at issue) and autism. In fact, the researchers managed to find that children suffering from neurological development delay were the ones with the lowest exposures to flame retardants.

So what did the researchers have to say about these findings? See pages 16 - 20 of the paper. Rather than simply reporting "we found no association between neurological development and exposure to flame retardants" the authors spend five pages saying why their exposure data is probably wrong and why even more studies of flame retardants and neurological development are needed.

Wouldn't it be nice, just once, if a scientist found an association between a chemical and some hot button disease and she spent her entire Discussion and Conclusion pointing out the reasons not to panic and not to jump to conclusions? That it doesn't happen when associations are found but does happen when the null hypothesis is confirmed says it all.

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A dozen years ago the National Law Journal had a write-up on a benzene / acute myelogenous leukemia case Herschel Hobson and I tried to verdict up in Texarkana, TX in Judge Folsom's court. The case was noteworthy as it was the first time the so-called benzene fingerprint defense had gone to a jury. Over Herschel's objection that it was junk science not generally accepted in the scientific community I got to put on evidence that benzene-induced leukemias are like therapy-related leukemias (t-AMLs), that the plaintiff didn't have the signature loss or deletion of chromosomes 5 and/or 7, and to argue that the plaintiff's leukemia could not therefore have been caused by benzene. Fate was with me however and so Herschel was quoted in the article as saying that the biomarker defense was all a bunch of baloney; or words to that effect.

The effort to identify markers of past benzene exposures continues and is intensifying. Interestingly, it's one of the plaintiffs bar's key experts who's leading the charge. For two brand new papers on the topic see (gated) "Chromosome-Wide Aneuploidy Study (CWAS) in Workers Exposed to an Established Leukemogen, Benzene" and (free) "Global Gene Expression of Profiling of a Population Exposed to a Range of Benzene Levels".

I must admit though that while putting on new science is exciting it's often not the game changer we'd like to believe. What almost certainly carried the day in that case was that the widow on cross examination opened the door to claims she'd made against other defendants over her husbands leukemia. Through another lawyer Herschel didn't know about she'd sued three dozen defendants in New York claiming that asbestos had caused her husband's cancer. (In the past recycling plaintiffs was not uncommon and I've seen a single family recover full damages from each of the asbestos, silica, benzene and butadiene defendants). As she read her New York complaint asserting that asbestos was the sole cause of her husband's cancer and that she was entitled to $40 million from each defendant the jurors one after another crossed their arms and sat back in their chairs. And that, was that.

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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.

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What is it? It's the view that "when a p-value is </= 0.05 then there is sufficient evidence that the drug works." In what I do it's also the claim that low p-values prove so-called general causation in a toxic tort case. The quotes come from a wonderfully readable paper just published in the Journal of the National Cancer Institute. It's: "Demystify Statistical Significance - Time to Move on From the P Value to Bayesian Analysis".

I particularly liked this: "Statistics in medicine has passed through its infancy and childhood. As it moves into its adolescence, the growing pains of reconciling frequentist and Bayesian views continue... Although the frequentist paradigm has been widely applied and is deeply rooted in medical research, it is time to move on and look for a better solution."

The frequentist paradigm spawned most of the toxic tort litigation of the last few decades and it also provides an easy way to gin up grant money for researchers and funds for "consumer research" so don't expect it to yield to reason without a long and bitter fight. I predict the Mt Sinai and Collegium Ramazzini folks will man the ramparts of the frequentists' final redoubt.

That having been said, perhaps the legal empiricists, learning from medicine's experience with touching hot stoves, can avoid the pain and skip straight to Bayesian analysis. Yeah. Right.

Anyway, expect the fight over whether a drug should or shouldn't be approved, or should or shouldn't have been approved, to move on to Bayesian grounds.

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Having discovered statistical significance testing and thus p-values, (far too) many legal scholars have set about trying to uncover previously unknown first principles of tort law, otherwise unrecognizable causal relationships between stock markets and telecom regulations, and the secret biases of judges they don't like. Running a statistics app over the top of a bunch of numbers is easy these days. Anyone who can operate a laptop can do it. But finding someone who knows what's going on behind the overlay and why is as rare as finding someone who knows what's going on behind the Windows operating system and why.

Indeed, if you don't understand the bundle of assumptions, limitations and trade-offs that underlies statistical significance testing, especially when it's being misused as a form of semi-automated induction, you can wind up proving that ESP is real. That's the real moral of the NYTimes' story "Journal's Paper on ESP Expected to Prompt Outrage" and it's why the publication of the paper discussed in the story is so deliciously subversive. I'm quite certain that a large part of the outrage isn't that junk science is being published - everybody already knows that most published scientific findings are false anyway. And it's not that people are going to realize that the peer-review process does not stop and was never designed to stop (so long as the methods and conclusions drawn from the data appear sound) obviously untrue conclusions about how nature works from being published - most people know that too. No, the real outrage I'd wager is from those who aren't happy that word has gotten out that the use of statistical significance testing, particularly in the social sciences, can be used to "scientifically prove" whatever you want to prove.

This week's NYTimes' Science and Health pages have surely been an eye-opener for those who think that what gets published in science journals is at least probably true. They've covered the XMRV controversy (about a made-up cause of a made-up disease), the debate over whether the autism-vaccine hoax was junk science or outright fraud and now the scientific peer-reviewed evidence that extra-sensory perception, at least when it comes to "erotic images", is real. If nothing else it may at least cause some people to be a bit more skeptical about science, even if it is peer-reviewed.

For those of you defending mass tort cases or handling any case where significance testing raises its head be sure to read "Evidence For Feeling The Future: An Assessment of The Evidence For Feeling The Future With A Discussionn of Bayes Factor and Significance Testing" linked at the end of the Times' story. Remember always that when using such frequentist techniques say in a chemical plant - styrene study you can never prove that styrene doesn't cause cancer - even if it doesn't - but if you collect enough data and test it enough you're guaranteed to eventually come up with some scientific evidence that will pass peer-review showing styrene does cause some form of cancer even though it doesn't. The best thing about the paper are the graphs. They're at the very end though referenced early on. If you don't want to wade through it here's the conclusion: "Our main methodological concern is that inference by p-values fails to seriously consider the null hypothesis as a viable possibility. Consequently, researchers who use it are apt to reject the null on the basis of insufficient evidence. We recommend that researchers adopt Bayes factor methodology, because this approach provides a rational and consistent assessment of the relative evidence between any two hypotheses (citing Edwards, W., Lindman, H., & Savage, L. J. (1963). Bayesian statistical inference for psychological research. Psychological Review, 70, 193-242)

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Wealth strongly and consistently correlates with good health and an overall reduced mortality risk. A new paper summarizing past research and presenting new data which confirms the link has just been published in the American Journal of Epidemiology. It's titled "Long-Term Effects of Wealth on Mortality and Self-rated Health Status". The study focused on self-reported perceptions of health status and the results mirrored those of the objective measure for mortality: socioeconomic status is a good predictor of health status.

Why do the least wealthy (aka the poor) tend to be the least healthy? Those pushing the cause of so-called environmental justice claim that the poor, who unsurprisingly live in the cheapest and thus least pristine areas, are exposed to toxic chemicals, electro-magnetic fields and ionizing radiation at levels far higher than the rich (who tend not to build their mansions next to refineries) and that such exposures are to blame. Others, the "real food" activists, claim that the poor live in a junk food environment and, the W.I.C. program notwithstanding, have not the means to come by nutritious food. Still others claim that the poor suffer from inadequate health care. There is though another reason the poor might be so afflicted. It was best stated by a now deceased safety man who spent his career with one of the oil companies in Port Arthur, TX as follows: "Poor folks got poor ways."

We were at the deposition of a retired refinery worker who was suffering from leukemia and who was giving a deposition before he passed away to be used by his wife in a subsequent gross negligence case against his and the safety man's employer. The deponent was asked by plaintiff's counsel, "If you'd have known about the dangers these chemicals like benzene posed would you have come to work for xxxx Oil Company?" The man, obviously prep'd for the question answered "No way. I'd 'a stayed in the piney woods loggin' like my daddy done. It might not 'a paid as much but I wouldn't 'a got this cancer". The safety man leaned over and said "Yeah, and he'd have died of cirrhosis at 48 just like his daddy done."

That old safety man went on to explain that the men who came out of the woods, and the cane fields and off the pogy boats to work hourly at those refineries often signed their job applications with an "X" but they wound up solidly in the middle class and their children or grandchildren made it to college and beyond. "Some couldn't even write their name when they got here and nobody ever went back to bein' a gawddamned logger from the xxxx Oil Company."

The epidemiological studies of those refinery work forces have repeatedly found that overall the men lived significantly longer, were significantly healthier and had a lower risk of all cancers combined than similar men in the general U.S. population - despite exposures to asbestos, benzene, butadiene and the like. Compared to loggers, and boat crews and farm laborers the average refinery worker bought himself six more years of healthy life just by going to work for better pay in an environment where middle class values were the norm.   

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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.

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