TORTINI

For your delectation and delight, desultory dicta on the law of delicts.

Science for Judges – Reference Manual v4.0

November 6th, 2024

By the time the third edition of the Reference Manual on Scientific Evidence (RMSE) arrived in 2011, the work had evolved into a massive doorstop. The third edition generally got favorable, but unsearching, reviews. In some ways it was an impressive effort, but it left a lot to be desired in terms of comprehensiveness and consistency.[1] A decade passed, and the National Academies of Science, Engineering, and Medicine (NASEM), along with the Federal Judicial Center, opened work on a fourth edition, in early 2021.[2]

A look at the NASEM website shows that work on the fourth edition of the RMSE is now completed. There is, however, no announced publication date. The website’s description of the RMSE project suggests that the fourth edition will continue the practice of individual chapters with different authors. The topics to be covered are listed as:

Behavioral and Social Sciences, Biology and Life Sciences, Computers and Information Technology, Earth Sciences, Education, Engineering and Technology, Environment and Environmental Studies, Health and Medicine, Math, Chemistry, and Physics, Policy for Science and Technology, and Surveys and Statistics.

It seems unlikely that the chapters will actually track these topics. Previous editions had specific chapters on epidemiology, toxicology, regression, and clinical medicine, among others. The listing of topics strikes me as a higher level of generality than the actual chapter headings.

The following project description is provided:

“In collaboration with the Federal Judicial Center (FJC), a committee of the National Academies of Sciences, Engineering, and Medicine will develop the fourth edition of the Reference Manual on Scientific Evidence.  The Reference Manual is a primary reference source for federal judges on questions of science in litigation.  It does not instruct judges on how to rule regarding admissibility of particular types of evidence, but instead offers judges advice on how to manage expert testimony, discusses emerging problems with expert testimony, and provides information on the methodology of areas of science that often present difficult issues when introduced in the form of expert testimony.

The manual is a compilation of individually-authored chapters on various topics of science and technology relevant to the courts, The fourth edition will include updates of existing chapters as well as new chapters that reflect emerging areas.  The committee will select the topics to be included in the manual, commission expert authors to revise the current chapters or draft new ones, approve the chapters, and submit the manual for external review.”

This description, at least as to previous editions, seems misleading. The first, second, and third editions contained very specific advice on specific issues. Indeed, it is unfathomable how a reference manual could avoid prescriptive judgments as to how scientific judgments should and should not be reached.

The Co-Chairs of the fourth edition are Hon. Nancy D. Freudenthal and Dr. Fred H. Gage. Members of the committee responsible for the new edition are:

Dr. Russ B. Altman (biomedical data, pharmacogenomics)

Hon. David G. Campbell (D. Ariz.)

Dr. Alicia L. Carriquiry (statistics, forensics)

Dr. Lynn R. Goldman (occupational and environmental health)

Dr. Brian W. Kernighan (engineering)

Dr. Pramod P. Khargonekar (engineering)

Hon. Goodwin Liu (California Supreme Court)

Dr. Shobita Parthasarathy (science, technology, and public policy)

Hon. Patti B. Saris (D. Mass.)

Hon. Thomas Schroeder (M.D.N.C.)

Hon. David S. Tatel (6th Circuit)

The Staff Officer for the project is Dr. Anne-Marie C. Mazza.

There is much that is needed in a new edition.  We will soon know whether the wait was worth it.[3]


[1] See, e.g., Adam Dutkiewicz, “Book Review: Reference Manual on Scientific Evidence, Third Edition,” 28 Thomas M. Cooley L. Rev. 343 (2011); John A. Budny, “Book Review: Reference Manual on Scientific Evidence, Third Edition,” 31 Internat’l J. Toxicol. 95 (2012); James F. Rogers, Jim Shelson, and Jessalyn H. Zeigler, “Changes in the Reference Manual on Scientific Evidence (Third Edition),” Internat’l Ass’n Def. Csl. Drug, Device & Biotech. Comm. Newsltr. (June 2012). See Schachtman “New Reference Manual’s Uneven Treatment of Conflicts of Interest,” Tortini (Oct. 12, 2011).

[2] Schachtman,“Reference Manual on Scientific Evidence v4.0Tortini (Feb. 28, 2021); Schachtman, “People Get Ready – There’s A Reference Manual A’Comin’,” Tortini (July 16, 2021); “Reference Manual on Scientific Evidence – 3rd Edition is Past Its ExpiryTortini (Oct. 17, 2021).

[3] I have written elsewhere of some of the issues that cry out for attention. Schachtman, “Reference Manual – Desiderata for the 4th Edition – Part I – Signature Diseases,” Tortini (Jan. 30, 2023); “Reference Manual – Desiderata for the 4th Edition – Part II – Epidemiology and Specific Causation,” Tortini (Jan. 31, 2023); “Reference Manual – Desiderata for the 4th Edition – Part III – Differential Diagnosis,” Tortini (Feb. 1, 2023); “Reference Manual – Desiderata for the 4th Edition – Part IV – Confidence Intervals,” Tortini (Feb. 10, 2023); “Reference Manual – Desiderata for the 4th Edition – Part V – Specific Tortogens,” Tortini (Feb. 14, 2023); “Reference Manual – Desiderata for the 4th Edition – Part VI – Rule 703,” Tortini (Feb. 17, 2023).

Junior Goes to Washington

November 4th, 2024

I do not typically focus on politics per se in these pages, but sometimes politicians wander into the domain of public health, tort law, and the like. And when they do, they become “fair game” so to speak for comment.

Speaking of “fair game,” back in August, Robert Fitzgerald Kennedy, Jr., [Junior] admitted to dumping a dead bear in Central Park, Manhattan, and fabricating a scene to mislead authorities into believing that the bear had died from colliding with a bicycle.[1] Junior’s bizarre account of his criminal activities can be found on X, home to so many dodgy political figures.

Junior, who claims to be an animal lover and who somehow became a member of the New York bar, says he was driving in upstate New York, early in the morning, to go falconing in the Hudson Valley. On his drive, he witnessed a driver in front of him fatally hit a bear cub. We have only Junior’s word that it was another driver, and not he, who hit the bear.

Assuming that Junior was telling the truth (big assumption), we would not know whether or how he could ascertain where the bear was injured by having been hit by another vehicle in front of his own vehicle. Junior continued his story:

“So I pulled over and I picked up the bear and put him in the back of my van, because I was gonna skin the bear. It was in very good condition and I was gonna put the meat in my refrigerator.”

Kennedy noted that New York law permits taking home a bear, killed on the road, but the law requires that the incident be reported to either the New York State Department of Environmental Conservation (DEC) or to the police, who will then issue a permit. In case you are interested in going roadkill collecting, you can contact the DEC at (518) 402-8883 or wildlife@dec.ny.gov.

Junior, the putative lawyer, flouted the law. He never did obtain a permit from a law enforcement officer, but nonetheless he took the bear carcass. The bear never made it back to Junior’s sometime residence. The six-month-old, 44-pound bear cub carcass lay a-moldering in the back of his van, while Kennedy was busy with his falcons. Afterwards, Junior found himself out of time and in need to rush to Brooklyn, for a dinner with friends at the Peter Luger Steak House. Obviously, Junior is not a vegetarian; nor is beaten down by the economy. A portherhouse steak at Luger’s costs over $140 per person. No credit cards accepted from diners. The dinner went late, while the blow flies were having at the bear cub.

Junior had to run to the airport (presumably in Queens), and as he explained:

“I had to go to the airport, and the bear was in my car, and I didn’t want to leave the bear in the car because that would have been bad.”

Bad, indeed. Bad, without a permit. Bad, without being gutted. Bad, without being refrigerated.

Junior had a brain storm, in the part of his brain that remains. He would commit yet another crime. (Unfortunately, the statute of limitations has likely run on the road kill incident.) Junior dumped the dead bear along with a bicycle in Central Park. The geography is curious. Peter Luger’s is in Brooklyn, although the chain also has a restaurant in Great Neck. From either location, traveling into Manhattan would be quite a detour.  There are plenty of parks closer to either restaurant location, or en route to the New York airports.

Junior’s crime was discovered the following day. Although the perpetrator was not identified until Junior’s confession, the crime scene was reported by no other than one of Junior’s Kennedy cousins, in the New York Times.[2]

Now as any hunter knows, if Junior were to have any chance of actually using the bear meat, he needed to gut the animal immediately to prevent the viscera from contaminating muscle tissue. His recklessness in handling of the carcass reflects a profound ignorance of food safety. Junior might have made the meat available to the needy, but his disregard for handling a dead animal rendered the carcass worthless. Last weekend, Felonious Trump announced, at a rally, that he had told Junior that “you work on what we eat.”

Let them eat roadkill or Peter Luger steaks.

Women’s Health Issues

Trump, the Lothario of a porn actress, the grab-them-by-the-pussy, adjudicated sexual abuser,[3] has also announced that he will put Junior in charge of women’s health issues.[4]  Junior appears to be a fellow traveler when it comes to “protecting” women. Back in July, Vanity Fair published the account of Ms. Eliza Cooney, a former babysitter for Junior’s children. According to Cooney, Junior groped her on several occasions.[5] Junior conveniently has no memory of the events, but nonetheless apologized profusely to Ms. Cooney.[6] Junior texted an “apology” to Ms. Cooney not long after the Vanity Fair article was published:

“I have no memory of this incident but I apologize sincerely for anything I ever did that made you feel uncomfortable or anything I did or said that offended you or hurt your feelings. I never intended you any harm. If I hurt you, it was inadvertent. I feel badly for doing so.”

Junior’s lack of memory may be due to his having lost some undisclosed amount of his brain to a worm that resided within his brain.[7] Even so, the apology combined with the profession of lack of memory was peculiar. Ms. Cooney, who is now 48, was understandably underwhelmed by Junior’s text messages:

“It was disingenuous and arrogant. I’m not sure how somebody has a true apology for something that they don’t admit to recalling. I did not get a sense of remorse.”[8]

Somehow the awfulness of placing Junior in “charge” of women’s health makes perfect sense in the administration of Donald Trump.

Health Agencies

If placing the integrity of women’s health and the safety of our food supply at risk is not enough to raise your concern, Trump apparently plans to let Junior have free rein with his “Make America Healthy Again” program. Just a few days ago, Trump announced that he was “going to let him [Junior] go wild on health. I’m going to let him go wild on the food. I’m going to let him go wild on the medicines.”[9]

Junior has forever hawked conspiracy theories and claims that vaccines cause autism and other diseases. As part of the lawsuit industry, Junior has sought to make money by demonizing vaccines and prescription medications. Recently, Howard Lutnick, the co-chair of the Trump transition team, after a lengthy conversation with Junior, recited Junior’s evidence-free claims that vaccines are not safe. According to Lutnick:

“I think it’ll be pretty cool to give him the data. Let’s see what he comes up with.”[10]

Pretty cool to let a monkey have a go at a typewriter, but it would take longer than the lifetime of the universe for a monkey to compose Hamlet. [11] Junior might well need that lifetime of universe, raised to the second power, to interpret the available extensive safety and efficacy data on vaccines.

 Junior has been part of the lawsuit industry and anti-vax conspiracist movement against vaccines for years. When asked whether “banning certain vaccines might be on the table,” Trump told NBC that “Well, I’m going to talk to him and talk to other people, and I’ll make a decision, but he’s [Junior’s] a very talented guy and has strong views.”

Strong views; weak evidence.

Junior asserted last weekend that the aspiring Trump administration would move quickly to end fluoridation of drinking water, even though fluoridation of water supplies takes place at the state, county, and municipal level. When interviewed by NBC, yesterday, Trump said he had not yet spoken to Junior about fluoride yet, “but it sounds OK to me. You know it’s possible.”[12] Junior, not particularly expert in anything, has opined that fluoride is “an industrial waste,” which he claims, sans good and sufficient evidence is “linked” to cancer and other unspecified diseases and disorders.[13]

If there is one possible explanation for this political positioning is that anti-vax propaganda plays into the anti-elite, anti-expert mindset of Trump and his followers. We should not be surprised that surprised that people who believe that Trump was a successful businessman, based upon a (non)-reality TV show, and multiple bankruptcies, would also have no idea of what success would look like for the scientific community.

At the end of the 20th century, the Centers for Disease Control reflected on the great achievements in public health.[14] The Centers identified a fairly uncontroversial list of 10 successes:

(1) Vaccination

(2) Motor-vehicle safety

(3) Safer workplaces

(4) Control of infectious diseases

(5) Decline in deaths from coronary heart disease and stroke

(6) Safer and healthier foods

(7) Healthier mothers and babies

(8) Family planning

(9) Fluoridation of drinking water

(10) Recognition of tobacco use as a health hazard

A second Trump presidency, with Junior at his side, would unravel vaccination and fluoridation, two of the ten great public health achievements of the last century. Trump has already shown a callous disregard for the control of infectious diseases, with his handling of the corona virus pandemic. Trump’s alignment with strident anti-abortion advocates and religious zealots has undermined the health of women, and ensured that many fetuses with severe congenital malformations must be brought to term. His right-wing anti-women constituency and their hostility to Planned Parenthood has undermined family planning. Trump’s coddling of American industry likely means less safe workplaces. Trump and Junior in positions of power would also likely mean less safe, less healthful foods. (A porterhouse or McDonald Big Mac on every plate?) So basically, seven, perhaps eight, of the ten great achievements would be reversed.

Happy Election Day!


[1] Rachel Treisman, “RFK Jr. admits to dumping a dead bear in Central Park, solving a decade-old mystery,” Nat’l Public Radio (Aug. 5, 2024).

[2] Tatiana Schlossberg, “Bear Found in Central Park Was Killed by a Car, Officials Say,” N.Y. Times (Oct. 7, 2014).

[3] Larry Neumeister, Jennifer Peltz, and Michael R. Sisak, “Jury finds Trump liable for sexual abuse, awards accuser $5M,” Assoc’d Press News (May 9, 2023).

[4]Trump brags about putting RFK Jr. in charge of women’s health,” MSNBC (Nov. 2024).

[5] Joe Hagan, “Robert Kennedy Jr’s Shocking History,” Vanity Fair (July 2, 2024).

[6] Mike Wendling, “RFK Jr texts apology to sexual assault accuser – reports,” BBC (July 12, 2024).

[7] Gabrielle Emanuel, “RFK Jr. is not alone. More than a billion people have parasitic worms,” Nat’l Public Radio (May 9, 2024).

[8] Peter Jamison, “RFK Jr. sent text apologizing to woman who accused him of sexual assault,” Washington Post (July 12, 2024).

[9] Bruce Y. Lee, “Trump States He’ll Let RFK Jr. ‘Go Wild’ On Health, Food, Medicines,” Forbes (Nov. 2, 2024).

[10] Dan Diamond, Lauren Weber, Josh Dawsey, Michael Scherer, and Rachel Roubein, “RFK Jr. set for major food, health role in potential Trump administration,” Wash. Post (Oct. 31, 2024).

[11] Stephen Woodcock & Jay Falletta, “A numerical evaluation of the Finite Monkeys Theorem,” 9 Franklin Open 100171 (2024).

[12] Jonathan J. Cooper, “RFK Jr. says Trump would push to remove fluoride from drinking water. ‘It’s possible,’ Trump says,” Assoc’d Press News (Nov. 3, 2024); William Kristol and Andrew Egger, “The Wheels on the Bus Go Off, and Off, and Off, and . . .,” The Bulwark (Nov. 4, 2024).

[13] Nadia Kounang, Carma Hassan and Deidre McPhillips, “RFK Jr. says fluoride is ‘an industrial waste’ linked to cancer, diseases and disorders. Here’s what the science says,” CNNHealth (Nov. 4, 2024).

[14] Centers for Disease Control, “Ten Great Public Health Achievements — United States, 1900-1999,”  48 Morbidity and Mortality Weekly Report 241 (Apr. 2, 1999).

Professor Lahav’s Radically Misguided Treatment of Chancy Tort Causation

September 27th, 2024

In the 19th and early 20th century, scientists and lay people usually conceptualized causation as “deterministic.” Their model of science was perhaps what was called Newtonian, in which observations were invariably described in terms of identifiable forces that acted upon antecedent phenomena. The universe was akin to a pool table, with the movement of the billiard balls fully explained by their previous positions, mass, and movements. There was little need for probability to describe events or outcomes in such a universe.

The 20th century ushered in probabilistic concepts and models in physics and biology. Because tort law is so focused on claims of bodily integrity and harms, I am focused here on claimed health effects. Departing from the Koch-Henle postulates and our understanding of pathogen-based diseases, the latter half of the 20th century saw the rise of observational epidemiology and scientific conclusions about stochastic processes and effects that could best be understood in terms of probabilities, with statistical inferences from samples of populations. The language of deterministic physics failed to do justice to epidemiologic evidence or conclusions. Modern medicine and biology invoked notions of base rates for chronic diseases, which rates might be modified by environmental exposures.

In the wake of the emerging science of epidemiology, the law experienced a new horizon on which many claimed tortogens did not involve exposures uniquely tied to the harms alleged. Rather, the harms asserted were often diseases of ordinary life, but with that suggested the harms were quantitatively more prevalent or incident among people exposed to the alleged tortogen. Of course, the backwaters of tort law saw reactionary world views on trial, as with claims of trauma-induced cancer cases, which are with us still. Nonetheless, slowly but not always steadily, the law came to grips with probability and statistical evidence.

In law, as in science, a key component of causal attribution is counterfactual analysis. If A causes B, then if in the same world, ceteris paribus, we do not have A, then we don’t have B. Counterfactual analysis applies as much to stochastic processes that are causally influenced by rate changes, as they apply to the Newtonian world of billiard balls. Some writers in the legal academy, however, would opportunistically use the advent of probabilistic analyses of health effects to dispose of science altogether. No one has more explicitly exploited the opportunity than Professor Alexandra Lahav.

In an essay published in 2022, Professor Lahav advanced extraordinary claims about probabilistic causation, or what she called “chancy causation.”[1] The proffered definition of chancy causation is bumfuzzling. Lahav provides an example of an herbicide that is “associated” with the type of cancer that the heavily exposed plaintiff developed. She tells us that:

“[t]here is a chance that the exposure caused his cancer, and a chance that it did not. Probability follows certain rules, or tendencies, but these regular laws do not abolish chance. This is a common problem in modern life, where much of what we know about medicines, interventions, and the chemicals to which we are exposed is probabilistic. Following the philosophical literature, I call this phenomenon chancy causation.”[2]

So the rules of probability do not abolish chance? It is hard to know what Lahav is trying to say here. Probability quantifies chance, and gives us an understanding of phenomena and their predictability. When we can model an empirical process with a probability distribution, such as one that is independent and identically distributed, we can often make and test quantitative inferences about the anticipated phenomena.

Lahav vaguely acknowledges that her term, “chancy causation” is borrowed, but she does not give credit to the many authors who have used it before.[3] Lahav does note that the concept of probabilistic causation used in modern-day risk factor epidemiology is different from the deterministic causal claims that dominated tort law in the 19th and the first half of the 20th century. Lahav claims that chancy causation is inconsistent with counterfactual analysis, but she cites no support for her claim, which is demonstrably false. If we previously saw the counterfactual of if A then B, as key to causality, we can readily restate the counterfactual as a probability: A probably causes B. On a counterfactual analysis, then if we do not have A as an antecedent, then we probably do not have B. For a classic tortogen such as tobacco smoking, we can say confidently that tobacco smoking probably causes lung cancer. And for a given instance of lung cancer, we can say based upon the entire evidentiary display, that if a person did not smoke tobacco, he would probably not have developed lung cancer. Of course, the correspondence is not 100 percent, which is only to say that it is probabilistic. There are highly penetrant genetic mutations that may be the cause of a given lung cancer case. We know, however, that such mutations do not cause or explain the large majority of lung cancer cases.

Contrary to Lahav’s ipse dixits, tort law can incorporate, and has accommodated, both general and specific causation in terms of probabilistic counterfactuals. The modification requires us, of course, to address the baseline situation as a rate or frequency of events, and the post-exposure world as one with a modified rate or frequency. Without confusion or embarrassment, we can say that the exposure is the cause of the change in event rates. Modern physics similarly addresses whether we must be content with probability statements, rather than precise deterministic “billiard ball” physics, which is so useful in a game of snooker, but less so in describing the position of sub-atomic particles. In the first half of the 20th century, the biological sciences learned with some difficulty that it must embrace probabilistic models, in genetic science, as well as in epidemiology. Many biological causation models are completely stated in terms of probabilities that are modified by specified conditions.

Lahav intends for her rejection of counterfactual causality to do a lot of work in her post-modern program. By falsely claiming that chancy causation has no factual basis, Lahav jumps to the conclusion that what the law calls for is nothing but “policy,”[4] and “normative decision.”[5] Having fabricated the demise of but-for causation in the context of probabilistic relationships, Lahav suggests that tort law can pretend that the causation question is nothing more than a normative analysis of the defendant’s conduct. (Perhaps it is more than a tad revealing that she does not see that the plaintiff’s conduct is involved in the normative judgment.) Of course, tort law already has ample room for policy and normative considerations built into the concepts of duty and breach of duty.

As we saw with the lung cancer example above, the claim that tobacco smoking probably caused the smoker to develop lung cancer can be entirely factual, and supported by a probabilistic judgment. Lahav calls her erroneous move “pragmatic,” although it has no relationship to the philosophical pragmatism of Peirce or Quine. Lahav’s move is an incorrect misrepresentation of probability and of epidemiologic science in the name of compensation free-for-alls. Obtaining a heads in the flip of a fair coin has a probability of 50%; that is a fact, not a normative decision, even though it is, to use Lahav’s vocabulary, “chancy.”

Lahav’s argument is not always easy to follow. In one place, she uses “chancy” to refer to the posterior probability of the correctness of the causal claim:

“the counterfactual standard can be successfully defended against by the introduction of chance. The more conflicting studies, the “more chancy” the causation. By that I do not mean proving a lower probability (although this is a good result from a defense point of view) but rather that more, different study results create the impression of irreducible chanciness, which in turn dictates that the causal relation cannot be definitively proven.”[6]

This usage, which clearly refers to the posterior probability of a claim, is not necessarily limited to so-called non-deterministic phenomena. People could refer to any conclusion, based upon conflicting evidence of deterministic phenomena, as “chancy.”

Lurking in her essay is a further confusion between the posterior probability we might assign to a claim, or to an inference from probabilistic evidence, and the probability of random error. In an interview conducted by Felipe Jiménez,[7] Lahav was more transparent in her confusion, and she explicitly commited the transpositional fallacy with her suggestion that customary statistical standards (statistical significance) ensure that even small increased risks, say of 30%, are known to a high degree of certainty.

Despite these confusions, it seems fairly clear that Lahav is concerned with stochastic causal processes, and most of her examples evidence that concern. Lahav poses a hypothetical in which epidemiologic studies show smokers have a 20% increased risk of developing lung cancer compared with non-smokers.[8] Given that typical smoking histories convey relative risks of 20 to 30, or increased risks of 2,000 to 3,000%, Lahav’s hypothetical may readers think she is shilling for tobacco compaies. In any event, in the face of a 20% increased risk (or relative rsk of 1.2), Lahav acknowledges that the probability of a smoker’s developing lung cancer is higher than that of a non-smoker, but “in any particular case the question whether a patient’s lung cancer was caused by smoking is uncertain.” This assertion, however, is untrue; the question is not “uncertain.” She has provided a certain quantification of the increased risk. Furthermore, her hypothetical gives us a good deal of information on which we can say that smoking probably did not result in the patient’s lung cancer. Causation may be chancy because it is based upon a probabilistic inference, but the chances are actual known, and they are low.

Lahav posits a more interesting hypothetical when she considers a case in which there is an 80% chance that a person’s lung cancer is attributable to smoking.[9] We can understand this hypothetical better if we reframe it as classic urn probability problem. In a given (large) population of non-smokers, we expect 100 lung cancers per year. In a population of smokers, otherwise just like the population of non-smokers, we observe 500 lung cancers. Of the observed number, 100 were “expected” because they happen without exposure to the putative causal agent, and 400 are “excess.”The relative risk would be 5, or 400% increased risk, and still well below the actual measure of risk from long-term smoking, but the attributable risk would be [(RR-1)/RR] or 0.8 (or 80%). If we imagine an urn with 100 white “expected” balls, and 400 red “excess” balls added, then any given draw from the urn, with replacement, yields an 80% probability of a red ball, or an excess case. Of course, if we can see the color, we may come to a consensus judgment that the ball is actually red. But on our analogy to discerning the cause of a given lung cancer, we have at present nothing by way of evidence with which to call the question, and so it remains “chancy” or probabilistic. The question is not, however, in any way normative. The answer is different quantitatively in the 20% and in the 400% hypotheticals.

Lahav asserts that we are in a state of complete ignorance once a smoker has lung cancer.[10] This is not, however, true. We have the basis for a probabilistic judgment that will probably be true. It may well be true that the probability of attribution will be affected by the probability that the relative risk = 5 is correct. If the posterior probability for the claim that smoking causes lung cancer by increasing its risk 400% is only 30%, then of course, we could not make the attribution in a given case with an 80% probability of correctness. In actual litigation, the argument is often framed on an assumption arguendo that the increased risk is greater than two, so that only the probability of attribution is involved. If the posterior probability of the claim that exposure to the tortogen increased risk by 400% or 20,000% was only 0.49, then the plaintiff would lose. If the posterior probability of the increased risk was greater than 0.5, the finder of fact could find that the specific causation claim had been carried if the magnitude of the relative risk, and the attributable risk, were sufficiently large. This inference on specific causation would not be a normative judgment; it would be guided by factual evidence about the magnitude of the relevant increased risk.

Lahav advances a perverse skepticism that any inferences about individuals can be drawn from information about rates or frequencies in groups of similar individuals.  Yes, there may always be some debate about what is “similar,” but successive studies may well draw the net tighter around what is the appropriate class. Lahav’s skepticism and her outright denialism about inferences from general causation to specific causation, are common among some in the legal academy, but it ignores that group to individual inferences are drawn in epidemiology in multiple contexts. Regressions for disease prediction are based upon individual data within groups, and the regression equations are then applied to future individuals to help predict those individuals’ probability of future disease (such as heart attack or breast cancer), or their probability of cancer-free survival after a specific therapy. Group to individual inferences are, of course, also the basis for prescribing decisions in clinical medicine.  These are not normative inferences; they are based upon evidence-based causal thinking about probabilistic inferences.

In the early tobacco litigation, defendants denied that tobacco smoking caused lung cancer, but they argued that even if it did, and the relative risk were 20, then the specific causation inference in this case was still insecure because the epidemiologic study tells us nothing about the particular case. Lahav seems to be channeling the tobacco-company argument, which has long since been rejected on the substantive law of causation. Indeed, as noted, epidemiologists do draw inferences about individual cases from population-based studies when they invoke clinical prediction models such as the Framingham cardiovascular risk event model, or the Gale breast cancer prediction model. Physicians base important clinical interventions, both pharmacologic and surgical, for individuals upon population studies. Lahav asserts, without evidence, that the only difference between an intervention based upon an 80% or a 30% probability is a “normative implication.”[11] The difference is starkly factual, not normative, and describes a long-term likelihood of success, as well as an individual probability of success.

Post-Modern Causation

What we have in Lahav’s essay is the ultimate post-modern program, which asserts, without evidence, that when causation is “chancy,” or indeterminate, courts leave the realm of science and step into the twilight zone of “normative decisions.” Lahav suggests that there is an extreme plasticity to the very concept of causation such that causation can be whatever judges want it to be. I for one sincerely doubt it. And if judges make up some Lahav-inspired concept of normative causation, the scientific community would rightfully scoff.

Establishing causation can be difficult, and many so-called mass tort litigations have failed for want of sufficient, valid evidence supporting causal claims. The late Professor Margaret Berger reacted to this difficulty in a more forthright way by arguing for the abandonment of general causation, or cause-in-fact, as an element of tort claims under the law.[12] Berger’s antipathy to requiring causation manifested in her hostility to judicial gatekeeping of the validity of expert witness opinions. Her animus against requiring causation and gatekeeping under Rule 702 was so strong that it exceeded her lifespan. Berger’s chapter in the third edition of the Reference Manual on Scientific Evidence, which came out almost one year after her death, embraced the First Circuit’s notorious anti-Daubert decision in Milward, which also post-dated her passing.[13]

Professor Lahav has previously expressed a distain for the causation requirement in tort law. In an earlier paper, “The Knowledge Remedy,” Lahav argued for an extreme, radical precautionary principle approach to causation.[14] Lahav believes that the likes of David Michaels have “demonstrated” that manufactured uncertainty is a genuine problem, but not one that affects her main claims. Remarkably, Lahav sees no problem with manufactured certainty in the advocacy science of many authors or the lawsuit industry.[15] In “Chancy Causation,” Lahav thus credulously repeats Michaels’ arguments, and goes so far as to describe Rule 702 challenges to causal claims as having the “negative effect” of producing “incentives to sow doubt about epidemiologic studies using methodological battles, a strategy pioneered by the tobacco companies … .”[16] Lahav’s agenda is revealed by the absence of any corresponding concern about the negative effect of producing incentives to overstate the findings, or the validity of inferences, in order to obtain an unwarranted and unsafe verdicts for claimants.


[1] Alexandra D. Lahav, “Chancy Causation in Tort,” 15 J. Tort L. 109 (2022) [hereafter Chancy Causation].

[2] Chancy Causation at 110.

[3] See, e.g., David K. Lewis, Philosophical Papers: Volume 2 175 (1986); Mark Parascandola, “Evidence and Association: Epistemic Confusion in Toxic Tort Law,” 63 Phil. Sci. S168 (1996).

[4] Chancy Causation at 109.

[5] Chancy Causation at 110-11.

[6] Chancy Causation at 129.

[7] Felipe Jiménez, “Alexandra Lahav on Chancy Causation in Tort,” The Private Law Podcast (Mar. 29, 2021).

[8] Chancy Causation at 115.

[9] Chancy Causation at 116-17.

[10] Chancy Causation at 117.

[11] Chancy Causation at 119.

[12] Margaret A. Berger, “Eliminating General Causation: Notes towards a New Theory of Justice and Toxic Torts,” 97 Colum. L. Rev. 2117 (1997).

[13] Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir. 2011), cert. denied sub nom., U.S. Steel Corp. v. Milward, 132 S. Ct. 1002 (2012).

[14] Alexandra D. Lahav, “The Knowledge Remedy,” 98 Texas L. Rev. 1361 (2020). See “The Knowledge Remedy ProposalTortini (Nov. 14, 2020).

[15] Chancy Causation at 118 (citing plaintiffs’ expert witness David Michaels, The Triumph of Doubt: Dark Money and the Science of Deception (2020), among others).

[16] Chancy Causation at 129.

800 Plaintiffs Fail to Show that Glyphosate Caused Their NHL

September 11th, 2024

Last week, Barbara Billauer, at the American Council on Science and Health[1] website, reported on the Australian court that found insufficient scientific evidence to support plaintiffs’ claims that they had developed non-Hodgkin’s lymphoma (NHL) from their exposure to Monsanto’s glyphosate product. The judgment had previously been reported by the Genetic Literacy Project,[2] which republished an Australian news report from July.[3] European news media seemed more astute in reporting the judgment, with The Guardian[4] and Reuters reporting the court decision in July.[5] The judgment was noteworthy because the mainstream and legal media in the United States generally ignored the development.  The Old Gray Lady and the WaPo in the United States, both of which have covered previous glyphosate cases in the United States, sayeth naught. Crickets at Law360.

On July 24, 2024, Justice Michael Lee, for the Federal Court of Australia, ruled that there was insufficient evidence to support the claims of 800 plaintiffs that their NHL had been caused by glyphosate exposure.[6] Because plaintiffs’ claims were aggregated in a class, the judgment against the class of 800 or so claimants, was the most significant judgment in glyphosate litigation to date.

Justice Lee’s opinion is over 300 pages long, and I have had a chance only to skim it. Regardless of how the Australian court handled various issues, one thing is indisputable: the court has given a written record of its decision processes for the world to assess, critique, validate, or refute. Jury trials provide no similar opportunity to evaluate the reasoning processes (vel non) of the decision maker. The absence of transparency, and an opportunity to evaluate the soundness of verdicts in complex medical causation, raises the question whether jury trials really satisfy the legal due process requirements of civil adjudication.


[1] Barbara Pfeffer Billauer, “The RoundUp Judge Who Got It,” ACSH (Aug. 29, 2024).

[2] Kristian Silva, “Insufficient evidence that glyphosate causes cancer: Australian court tosses 800-person class action lawsuit,” ABC News (Australia) (July 26, 2024).

[3] Kristian Silva, “Major class action thrown out as Federal Court finds insufficient evidence to prove weedkiller Roundup causes cancer,” ABC Australian News (July 25, 2024).

[4] Australian Associated Press, “Australian judge dismisses class action claiming Roundup causes cancer,” The Guardian (July 25, 2024).

[5] Peter Hobson and Alasdair Pal, “Australian judge dismisses lawsuit claiming Bayer weedkiller causes blood cancer,” Reuters (July 25, 2024).

[6] McNickle v. Huntsman Chem. Co. Australia Pty Ltd (Initial Trial) [2024] FCA 807.

The Genuine Liberal Meaning of Rule 702

September 7th, 2024

This spring, I had the chance to participate on a panel at the Defense Research Institute’s annual seminar on drug and medical device law. It was a pleasure to work with Dr. Ivan Oransky and Dr. Erica James, in organizing and presenting on the issues surrounding dodgy science and publication retractions, and how their courtroom implications. The panel was officially titled, “Fraud, Error, and Ethics Violations: Exposing Bad Science in Litigation.” Dr. Oransky’s presentation focused on his keen journalistic accounts of retractions and the unraveling of trust in peer review of scientific publications.

As part of that panel, I wrote a paper on “The Convergence of Law and Science on Epistemic Virtues and Vices,” which I hope to develop further this fall. Preparing this paper led me to expand upon aspects of the judicial gatekeeping of expert witness opinion testimony, mandated by Federal Rule of Evidence 702. Some of these thoughts are also presented in a post for the Center for Truth in Science.[1]

Critics of judicial gatekeeping often suggest that the procedures of FRE 702 and 703 run contrary to the “liberal” thrust of the Federal Rules. This interpretative strategy has led to various abuses, including shifting the statutory burden of proving foundational requirements, completely eliminating foundational requirements, and relying upon cases as precedents that were clearly abandoned by statutory enactments and amendments of Rule 702 , or otherwise overruled in Daubert, Joiner, or Kumho Tire.

The courts that have invoked “liberal” thrusts, and made-up presumptions of validity, are mistaken about what is truly liberal and liberating. Under the common law, before the Federal Rules of Evidence were adopted in 1975, expert witness opinion had to be primarily relevant, as well as given by a witness qualified by virtue of education, training, or experience. From the perspective of the fact finder and the process of adjudication, the common law was an authoritarian standard that imposed opinions upon the fact finder by virtue of witness credentials and status.

The liberal response to such an authoritarian standard is to free the court and the fact finder from authoritarian opinion and to require that proffered opinions actually meet minimal requirements of validity, in terms of their underlying data, methodology, inferences, and application ot the facts of the case. An authoritarian evidentiary regime is willing to impose upon a non-expert decision maker, and to require it to reach judgments on the ipse dixit pronouncements of expert witnesses. A liberal regime must reject this authoritarianism and require some minimal level of justification, even though it will lead to closing the gate to poorly considered, inadequately supported opinion testimony. Although fewer proffered opinions may get through the gate, the Federal Rules of Evidence ushered in a liberal regime that is focused on ascertaining the truth rather than paying obeisance to status and authority of a speaker. Properly understood, Rule 702 is indeed a liberal rule that should have always been construed to “the end of ascertaining the truth and securing a just determination.[2] Importantly, Rule 702 is not, and never was, the libertine rule sought by the lawsuit industry.


[1] Schachtman, “Why Rule 702: US judges serve as gatekeepers for the truth in science,” Center for Truth in Science (July 18, 2024).

[2] Fed. R. Evid. Rule 102. Purpose.

Fraudulent Asbestos Diagnoses Redux

August 27th, 2024

An Associated Press journalist reported on an appeal from an interesting judgment, which few other journalists have followed.[1] Last week, Matthew Brown filed a report on an appeal before the Ninth Circuit challenging a judgment against a health clinic that had diagnosed supposed asbestos-related diseases among residents of Libby, Montana. The BNSF Railway (Burlington Northern Santa Fe Corporation) challenged the validity of more than 2,000 of the clinic’s diagnoses, in a qui tam action. A federal court jury in Missoula found that the Railway had carried its burden of proving that 337 of the cases were indeed false claims. The clinic’s fraud had made its patients wrongly entitled to various federally funded benefit programs. The Railway’s tenuous connection to the underlying claims was that its railroad serviced the vermiculite mine outside of town, and its trains passed through town.

According to Brown, Plaintiff BNSF claimed that the clinic had made its diagnoses of asbestos-related disease solely upon chest radiographs. The clinic apparently defended by confession and avoidance. Yes, it had made diagnoses solely upon radiographs, but its physicians claimed that they had done so in good faith, based upon guidance of federal officials. This defense seems rather dodgy given that asbestosis does not manifest as a unique radiographic pattern.                                                                                                

The False Claims Act case resulted in a verdict of $5.8 million in penalties and damages, with one quarter of that amount going to BNSF as the relator. The federal government had declined to prosecute the case under the Act. After judgment was entered on the verdict, CART filed for bankruptcy, but its petition was dismissed at the request of the federal government. Lawyers for the government argued that the U.S. Department of Health and Human Services was the principal funder of the clinic, as well as its primary creditor. The costs of the bankruptcy would simply fall on taxpayers, who along with the Libby-area residents, were the victims of CART’s fraud.  The defendant clinic has appealed on grounds of erroneous jury instructions, according to its appellate lawyer, Tim Bechtold.

The AP story has a sub-headline claiming “[i]ndependent, fact-based, nonpartisan reporting.” Well, maybe not.

1. For some reason, Brown was coy about identifying the fraudfeasor medical clinic. The defendant in the case was the Center for Asbestos-Related Disease, Inc. (CART). Similarly, he did not identify any of the medical personnel who submitted false claims. CART had a physical presence in Libby, Montana, where W.R. Grace mined vermiculite for many years. The group has apparently filed for bankruptcy, but its website is still active. CART’s website’s landing page describes the Center as providing “advocacy, screening, care, and resources.” Notably, “advocacy” was listed first, which might not be exactly what physicians should prioritize.

2. Mr. Brown states that “[e]xposure to even a minuscule amount of asbestos can cause lung problems, according to scientists.” As Peter Woit put it, this characterization is not even wrong. Asbestos is a commercial term for six different minerals, but only in their fibrous habit. The potency for causing some diseases in humans varies by orders of magnitude among the mineral varieties. Since only god can make asbestos, and because the different varieties of asbestos are omnipresent in the natural environment, and because humans have natural defenses to inhaled minerals at levels even above “minuscule amounts,” Brown’s quote is nothing more than lawsuit industry propaganda. His statement about minuscule exposures is noteworthy for not having any identified source, although Brown used the exact phrase in an earlier article on the jury verdict.[2]

3. Mr. Brown does not provide the caption of the case he is describing, which seems like poor journalistic practice. For readers interested in the never-ending sage of fraudulent asbestos claims, the case was BNSF Railway v. Center for Asbestos Related Disease, Inc., No. CV 19-40-M-DLC (D. Mont. July 18, 2023). Some other proceedings of the case in district court are also available online. The oral argument is quite revealing in showcasing the parties’ stipulation that asbestosis cannot be diagnosed by B-readers and their interpretation of chest radiographs. The shoddy evidentiary foundations of many of the claims supported by CART are reminiscent of the fraud in In re Silica Products Liability Litigation, 398 F. Supp. 2d 563 (S.D. Tex. 2005).

4. Although Mr. Brown was reporting on the upcoming oral argument in the Ninth Circuit, he did not link to the video of that argument, which is available at the Circuit’s website. The Ninth Circuit’s docket number is 23-35507, and the case was heard on August 21, last week, by a panel of Judges Christen, Nguyen, and Hurwitz.

5. Mr. Brown provided no discussion or analysis whether CART’s defense was coherent or valid. The interested audience members can listen to the Ninth Circuit oral argument, and judge for themselves. I for one found the documented diagnostic practices “shocking and outrageous,” as Judge Clark Brown (of Boston Legal fame) used to say. By virtue of a federal statute, Libby area residents who have been diagnosed with an asbestos-related disease are eligible for various services, including Medicare, housekeeping, travel to medical appointments and disability benefits, at taxpayer expense.


[1] Matthew Brown, “Montana asbestos clinic seeks to reverse $6M in fines, penalties over false claims,” Assoc. Press News (Aug 21, 2024).

[2] Matthew Brown, “Montana health clinic must pay nearly $6 million over false asbestos claims, judge rules,” P.B.S. Newshour (July 23, 2023).

Zhang’s Glyphosate Meta-Analysis Succumbs to Judicial Scrutiny

August 5th, 2024

Back in March 2015, the International Agency for Research on Cancer (IARC) issued its working group’s monograph on glyphosate weed killer. The report classified glyphosate as a “probable carcinogen,” which is highly misleading. For IARC, the term “probable” does not mean more likely than not, or for that matter, probable does not have any quantitative meaning. The all-important statement of IARC methods, “The Preamble,” makes this clear.[1] 

In the case of glyphosate, the IARC working group concluded that the epidemiologic evidence for an association between glyphosate exposure and cancer (specifically non-Hodgkins lymphoma (NHL)), was limited, which is IARC’s euphemism for insuffcient. Instead of epidemiology, IARC’s glyphosate conclusion was based largely upon rodent studies, but even the animal evidence relied upon by IARC was dubious. The IARC working group cherry picked a few arguably “positive” rodent study results with increases in tumors, while ignoring exculpatory rodent studies with decreasing tumor yield.[2]

Although the IARC hazard classification was uncritically embraced by the lawsuit industry, most regulatory agencies, even indulging precautionary principle reasoning, rejected the claim of carcinogenicity. The United States  Environmental Protection Agency (EPA), European Food Safety Authority, Food and Agriculture Organization (in conjunction with World Health Organization, European Chemicals Agency, Health Canada, German Federal Institute for Risk Assessment, among others, found that the scientific evidence did not support the claim that glyphosate causes NHL. The IARC monograph very quickly after publication became the proximate cause of a huge litigation effort by the lawsuit industry against Monsanto.

The personal injury cases against Monsanto, filed in federal court, were aggregated for pre-trial hearing, before Judge Vince Chhabria, of the Northern District of California, as MDL 2741. Judge Chhabria denied Monsanto’s early Rule 702 motions, and thus cases proceeded to trial, with mixed results.

In 2019, the Zhang study, a curious meta-analysis of some of the available glyphosate epidemiologic studies appeared in Mutation Research / Reviews in Mutation Research, a toxicology journal that seemed an unlikely venue for a meta-analysis of epidemiologic studies. The authors combined selected results from one large cohort study, the Agricultural Health Study, along with five case-control studies, to reach a summary relative risk of 1.41 (95% confidence interval 1.13-1.75).[3] According to the authors, their “current meta-analysis of human epidemiological studies suggests a compelling link between exposures to GBHs [glyphosate] and increased risk for NHL.”

The Zhang meta-analysis was not well reviewed in regulatory and scientific circles. The EPA found that Zhang used inappropriate methods in her meta-analysis.[4] Academic authors also panned the Zhang meta-analysis in both scholarly,[5] and popular articles.[6] The senior author of the Zhang paper, Lianne Sheppard, a Professor in the University of Washington Departments of Environmental  and  Occupational Health Sciences, and Biostatistics, attempted to defend the study, in Forbes.[7] Professor Geoffrey Kabat very adeptly showed that this defense was futile.[8] Despite the very serious and real objections to the validity of the Zhang meta-analysis, plaintiffs’ expert witnesses, such as Beate Ritz, an epidemiologist with U.C.L.A. testified that she trusted and relied upon the analysis.[9]

For five years, the Zhang study was a debating point for lawyers and expert witnesses in the glyphosate litigation, without significant judicial gatekeeping. It took the entrance of Luoping Zhang herself as an expert witness in the glyphosate litigation, and the procedural oddity of her placing exclusive reliance upon her own meta-analysis, to bring the meta-analysis into the unforgiving light of judicial scrutiny.

Zhang is a biochemist and toxicologist, in the University of California, Berkeley. Along with two other co-authors of her 2019 meta-analysis paper, she had been a board member of the EPA’s 2016 scientific advisory panel on glyphosate. After plaintiffs’ counsel disclosed Zhang as an expert witness, she disclosed her anticipated testimony, as is required by Federal Rule of Civil Procedure 26, by attaching and adopting by reference the contents of two of her published papers. The first paper was her 2019 meta-analysis; the other paper discussed putative mechanisms. Neither paper concluded that glyphosate causes NHL. Zhang’s disclosure did not add materially to her 2019 published analysis of six epidemiologic studies on glyphosate and NHL.

The defense challenged the validity of Dr. Zhang’s proffered opinions, and her exclusive reliance upon her own 2019 meta-analysis required the MDL court to pay attention to the failings of that paper, which had previously escaped critical judicial scrutiny. In June 2024, after an oral hearing in Bulone v. Monsanto, at which Dr. Zhang testified, Judge Chhabria ruled that Zhang’s proffered testimony, and her reliance upon her own meta-analysis was “junk science.”[10]

Judge Chhabria, perhaps encouraged by the recently fortifying amendment to Rule 702, issued a remarkable opinion that paid close attention to the indicia of validity of an expert witness’s opinion and the underlying meta-analysis. Judge Chhabria quickly spotted the disconnect between Zhang’s published papers and what is required for an admissible causation opinion. The mechanism paper did not address the extant epidemiology, and both sides in the MDL had emphasized that the epidemiology was critically important for determining whether there was, or was not, causation.

Zhang’s meta-analysis did evaluate some, but not all, of the available epidemiology, but the paper’s conclusion stopped considerably short of the needed opinion on causation. Zhang and colleagues had concluded that there was a “compelling link” between exposures to [glyphosate-based herbicides] and increased risk for NHL. In their paper’s key figure, show casing the summary estimate of relative risk of 1.41 (95% C.I., 1.13 -1.75), Zhang and her co-authors concluded only that exposure was “associated with an increased risk of NHL.” According to Judge Chhabria, in incorporating her 2019 paper into her Rule 26 report, Zhang failed to add a proper holistic causation analysis, as had other expert witnesses who had considered the Bradford Hill predicates and considerations.

Judge Chhabria picked up on another problem that has both legal and scientific implications. A meta-analysis is out of date as soon as a subsequent epidemiologic study becomes available, which would have satisfied the inclusion criteria for the meta-analysis. Since publishing her meta-analysis in 2019, additional studies had in fact been published. At the hearing, Dr. Zhang acknowledged that several of them would qualify for inclusion in the meta-analysis, per her own stated methods. Her failure to update the meta-analysis made her report incomplete and inadmissible for a court matter in 2024.

Judge Chhabria might have stopped there, but he took a closer look at the meta-analysis to explore whether it was a valid analysis, on its own terms. Much as Chief Judge Nancy Rosenstengel had done with the made-for-litigation meta-analysis concocted by Martin Wells in the paraquat litigation,[11] Judge Chhabria examined whether Zhang had been faithful to her own stated methods. Like Chief Judge Rosenstengel’s analysis, Judge Chhabria’s analysis stands as a strong rebuttal to the uncharitable opinion of Professor Edward Cheng, who has asserted that judges lack the expertise to evaluate the “expert opinions” before them.[12]

Judge Chhabria accepted the intellectual challenge that Rule 702 mandates. With the EPA memorandum lighting the way, Judge Chhabria readily discerned that “the challenged meta-analysis was not reliably performed.” He declared that the Zhang meta-analysis was “junk science,” with “deep methodological problems.”

Zhang claimed that she was basing the meta-analysis on the subgroups of six studies with the heaviest glyphosate exposure. This claim was undermined by the absence of any exposure-response gradient in the study deemed by Zhang to be of the highest quality. Furthermore, of the remaining five studies, three studies failed to provide any exposure-dependent analysis other than a comparison of NHL rates among “ever” versus “never” glyphosate exposure. As a result of this heterogeneity, Zhang used all the data from studies without exposure characterizations, but only limited data from the other studies that analyzed NHL by exposure levels. And because the highest quality study was among those that provided exposure level correlations, Zhang’s meta-analysis used only some of the data from it.

The analytical problems created by Zhang’s meta-analytical approach were compounded by the included studies’ having measured glyphosate exposures differently, with different cut-points for inclusion as heavily exposed. Some of the excluded study participants would have heavier exposure than those included in the summary analysis.

In the universe of included studies, some provided adjusted results from multi-variate analyses that included other pesticide exposures. Other studies reported only unadjusted results. Even though Zhang’s method stated a preference for adjusted analyses, she inexplicably failed to use adjusted data in the case of one study that provided both adjusted and unadjusted results.

As shown in Judge Chhabria’s review, Zhang’s methodological errors created an incoherent analysis, with methods that could not be justified. Even accepting its own stated methodology, the meta-analysis was an exercise in cherry picking. In the court’s terms, it was, without qualification, “junk science.”

After the filing of briefs, Judge Chhabria provided the parties an oral hearing, with an opportunity for viva voce testimony. Dr. Zhang thus had a full opportunity to defend her meta-analysis. The hearing, however, did not go well for her. Zhang could not talk intelligently about the studies included, or how they defined high exposure. Zhang’s lack of familiarity with her own opinion and published paper was yet a further reason for excluding her testimony.

As might be expected, plaintiffs’ counsel attempted to hide behind peer review. Plaintiffs’ counsel attempted to shut down Rule 702 scrutiny of the Zhang meta-analysis by suggesting that the trial court had no business digging into validity concerns given that Zhang had published her meta-analysis in what apparently was a peer reviewed journal. Judge Chhabria would have none of it. In his opinion, publication in a peer-reviewed journal cannot obscure the glaring methodological defects of the relied upon meta-analysis. The court observed that “[p]re-publication editorial peer review, just by itself, is far from a guarantee of scientific reliability.”[13] The EPA memorandum was thus a more telling indicator of the validity issues than the publication in a nominally peer-reviewed journal.

Contrary to some law professors who are now seeking to dismantle expert witness gatekeeping as beyond a judge’s competence, Judge Chhabria dismissed the suggestion that he lacked the expertise to adjudicate the validity issues. Indeed, he displayed a better understanding of the meta-analytic process than did Dr. Zhang. As the court observed, one of the goals of MDL assignments was to permit a single trial judge to have time to engage with the scientific issues and to develop “fluency” in the relevant scientific studies. Indeed, when MDL judges have the fluency in the scientific concepts to address Rule 702 or 703 issues, it would be criminal for them to ignore it.

The Bulone opinion should encourage lawyers to get “into the weeds” of expert witness opinions. There is nothing that a little clear thinking – and glyphosate – cannot clear away. Indeed, now that the weeds of Zhang’s meta-analysis are cleared away, it is hard to fathom that any other expert witness can rely upon it without running afoul of both Federal Rules of Evidence 702 and 703.

There were a few issues not addressed in Bulone. As seen in her oral hearing testimony, Zhang probably lacked the qualifications to proffer the meta-analysis. The bar for qualification as an expert witness, however, is sadly very low. One other issue that might well have been addressed is Zhang’s use of a fixed effect model for her meta-analysis. Considering that she was pooling data from cohort and case-control studies, some with and some without adjustments for confounders, with different measures of exposure, and some with and some without exposure-dependent analyses, Zhang and her co-authors were not justified in using a fixed effect model for arriving at a summary estimate of relative risk. Admittedly, this error could easily have been lost in the flood of others.

Postscript

Glyphosate is not merely a scientific issue. Its manufacturer, Monsanto, is the frequent target of media outlets (such as Telesur) from autocratic countries, such as Communist China and its client state, Venezuela.[14]

天安门广场英雄万岁


[1]The IARC-hy of Evidence – Incoherent & Inconsistent Classifications of Carcinogenicity,” Tortini (Sept. 19, 2023).

[2] Robert E Tarone, “On the International Agency for Research on Cancer classification of glyphosate as a probable human carcinogen,” 27 Eur. J. Cancer Prev. 82 (2018).

[3] Luoping Zhang, Iemaan Rana, Rachel M. Shaffer, Emanuela Taioli, Lianne Sheppard, “Exposure to glyphosate-based herbicides and risk for non-Hodgkin lymphoma: A meta-analysis and supporting evidence,” 781 Mutation Research/Reviews in Mutation Research 186 (2019).

[4] David J. Miller, Acting Chief Toxicology and Epidemiology Branch Health Effects Division, U.S. Environmental Protection Agency, Memorandum to Christine Olinger, Chief Risk Assessment Branch I, “Glyphosate: Epidemiology Review of Zhang et al. (2019) and Leon et al. (2019) publications for Response to Comments on the Proposed Interim Decision” (Jan. 6, 2020).

[5] Geoffrey C. Kabat, William J. Price, Robert E. Tarone, “On recent meta-analyses of exposure to glyphosate and risk of non-Hodgkin’s lymphoma in humans,” 32 Cancer Causes & Control 409 (2021).

[6] Geoffrey Kabat, “Paper Claims A Link Between Glyphosate And Cancer But Fails To Show Evidence,” Science 2.0 (Feb. 18, 2019).

[7] Lianne Sheppard, “Glyphosate Science is Nuanced. Arguments about it on the Internet? Not so much,” Forbes (Feb. 20, 2020).

[8] Geoffrey Kabat, “EPA Refuted A Meta-Analysis Claiming Glyphosate Can Cause Cancer And Senior Author Lianne Sheppard Doubled Down,” Science 2.0 (Feb. 26, 2020).

[9] Maria Dinzeo, “Jurors Hear of New Study Linking Roundup to Cancer,” Courthouse News Service (April 8, 2019).

[10] Bulone v. Monsanto Co., Case No. 16-md-02741-VC, MDL 2741 (N.D. Cal. June 20, 2024). See Hank Campbell, “Glyphosate legal update: Meta-study used by ambulance-chasing tort lawyers targeting Bayer’s Roundup as carcinogenic deemed ‘junk science nonsense’ by trial judge,” Genetic Literacy Project (June 24, 2024).

[11] In re Paraquat Prods. Liab. Litig., No. 3:21-MD-3004-NJR, 2024 WL 1659687 (S.D. Ill. Apr. 17, 2024) (opinion sur Rule 702 motion), appealed sub nom., Fuller v. Syngenta Crop Protection, LLC, No. 24-1868 (7th Cir. May 17, 2024). SeeParaquat Shape-Shifting Expert Witness Quashed,” Tortini (April 24, 2024).

[12] Edward K. Cheng, “The Consensus Rule: A New Approach to Scientific Evidence,” 75 Vanderbilt L. Rev. 407 (2022). SeeCheng’s Proposed Consensus Rule for Expert Witnesses,” Tortini (Sept. 15, 2022); “Further thoughts on Cheng’s Consensus Rule,” Tortini (Oct. 3, 2022).

[13] Bulone, citing Valentine v. Pioneer Chlor Alkali Co., 921 F. Supp. 666, 674-76 (D. Nev. 1996), for its distinction between “editorial peer review” and “true peer review,” with the latter’s inclusion of post-publication assessment of a paper as really important for Rule 702 purposes.

[14] Anne Applebaum, Autocracy, Inc.: The Dictators Who Want to Run the World 66 (2024).

STEM-ing the Tide of Scientific & Mathematical Illiteracy in the Law

July 31st, 2024

I will blame the heat of this summer for reducing my blog posts to a trickle, but I have written elsewhere. The James G. Martin Center for Academic Renewal invited me to write a piece about the need for science and mathematics literacy in law school, and among lawyers and judges. I have touched on the subject before, but I agreed to submit a short essay that is now published as “STEM-ing the Tide of Scientific and Mathematical Illiteracy in the Law: Attorneys need to understand how numbers work. It’s time we teach them,” James G. Martin Center (July 26, 2024).

Although I was delighted to receive the invitation, I was initially skeptical of the organization. The James G. Martin Center for Academic Renewal (previously known as the Pope Center for Higher Education Policy) is a group that has criticized and sought reforms in higher education from a right-of-center perspective. I have given up calling such groups “conservative,” because the term no longer has any clear meaning. While I continue to view Burke and Oakeshott as having something important to say about our current crises, their counsel has no sway among self-styled conservatives in the Republican party, where neo-cons, theo-cons, paleo-cons, fascismo-cons, crypto-cons, techno-cons, ignoratio-cons, and plain ol’ con-cons have pitched one large ignominious tent.

Still, as a group that describes itself as particularly concerned especially with free markets, limited constitutional government, and personal responsibility, the Martin Center has much to commend it. Although I cannot agree with everything promoted on the Center’s website, which has articles from many authors, the group’s publications seemed sufficiently heterodox to me to consider it as a publishing venue.

My piece focused on the need for a modicum of scientific and statistical acumen and training among lawyers, and the ethical lapses that can result from lack of training. I chose to use real world examples of lawyers whose pronouncements in public and in court caused them to look either untutored or unethical. There were no lack of examples, but perhaps as a test of the Martin Center’s bona fides, I focused on three high-profile “conservative” lawyers, Alan Dershowitz, Ken Paxton, and John Eastman. Of course, the last of these lawyers has now had his license suspended, pending an appeal to the California Supreme Court. I was gratified that the Martin Center received and enthusiastically published my short article, which is now online at the Center’s website.

David Egilman, Rest in Peace, Part 3

April 30th, 2024

Egilman was sufficiently clever to discern that if his “method” led to a conclusion that silicone gel breast implants cause autoimmune disease, but the Institute of Medicine, along with court-appointed experts, found no basis for a causal conclusion, then by modus tollens Egilman’s “method” was suspect and must be rejected.[1] This awareness likely explains the extent to which he went to cover up his involvement in the plaintiffs’ causation case in the silicone litigation.

Egilman’s selective leaking of Eli Lilly documents was also a sore point. Egilman’s participation in an unlawful conspiracy was carefully detailed in an opinion by the presiding judge, Hon. Jack Weinstein.[2] His shenanigans were also widely covered in the media,[3] and in the scholarly law journals.[4] When Egilman was caught with his hand in the cookie jar, and conspiring to distribute confidential Zyprexa documents to the press, he pleaded the fifth amendment. The proceedings did not go well, and Egilman ultimately stipulated to his responsibility for violating a court order, and agreed to pay a monetary penalty of $100,000. Egilman’s settlement was prudent. The Court of Appeals affirmed sanctions against Egilman’s co-conspirator, for what the court described as “brazen” conduct.[5]

 

Despite being a confessed contemnor, Egilman managed to attract a fair amount of hagiographic commentary.[6] An article in Science, described Egilman as “the scourge of companies he accuses of harming public health and corrupting science,”[7] and quoted fawning praise from his lawsuit industry employers: “[h]e’s a bloodhound who can sniff out corporate misconduct better than security dogs at an airport,”[8] In 2009, a screen writer, Patrick Coppola, announced that he was developing a script for a “Doctor David Egilman Project”. A webpage (still available on the Way-Back machine)[9] described the proposed movie as Erin Brockovich meets The Verdict. Perhaps it would have been more like King Kong meets Lenin in October.

After I started my blog, Tortini, in 2010, I occasionally commented upon David Egilman. As a result, I received occasional emails from various correpondents about him. Most were lawyers aggrieved by his behavior at deposition or in trial, or physicians libeled by him. I generally discounted those partisan and emotive accounts, although I tried to help by sharing transcripts from Egilman’s many testimonial adventures.

One email correspondent was Dennis Nichols, a well-respected journalist from Cincinnati, Ohio. Nichols had known Egilman in the early 1980s, when he was at NIOSH, in Cincinnait. Nichols had some interests in common with Egilman, and had socialized with him 40 years ago. Dennis wondered what had become of Egilman, and one day, googled Egilman, and found my post “David Egilman’s Methodology for Divining Causation.”  Nichols found my description of Egilman’s m.o. consistent with what he remembered from the early 1980s. In the course of our correspondence, Dennis Nichols shared his recollections of his interactions with the very young David Egilman. Dennis Nichols died in February 2022,[10] and I am taking the liberty of sharing his first-hand account with a broader audience.

“I met David Egilman only two or three times, and that was more than 30 years ago, when he was an epidemiologist at NIOSH. When I remarked on the content of conversation with him in about 1990, he and a lawyer representing him threatened to sue me for libel, to which I picked up the gauntlet. I had a ‘blood from the turnip’ defense to accompany my primary defense of truth, and besides, Egilman was widely known as a Communist.

I had lunch with Egilman in a Cincinnati restaurant in 1982 after someone suggested that he might be interested in supporting an arts and entertainment publishing venture that I was involved with, called The Outlook; notwithstanding that I was a conservative, The Outlook leaned left, and its key staff were Catholic pacifists and socialists. Over lunch, Egilman explained to me that he considered himself a Marxist-Leninist, his term, and that the day would come when people like him would have to kill people like me, again his language.

He subsequently invited me and the editor of The Outlook to a reception he had at his house on Mt. Adams, a Cincinnati upscale and Bohemian neighborhood, or at least as close as Cincinnati gets to Bohemian, where he served caviar that he had brought back from his most recent trip to Moscow and displayed poster-size photographs of Lenin, Marx, Stalin, Luxemburg, Gorky and other heroes of the Soviet Union and Scientific Socialism. I do not recall that Egilman admired Mao; the USSR had considerable tension in those years with China, and Egilman was clearly in the USSR camp in those days of Brezhnev, and he said so. Egilman said he traveled often to the Soviet Union, I think in the course of his work, which probably was not common in 1982.

The Outlook editor had met Egilman in the course of his advocacy journalism in reporting on the Fernald Feed Materials Production Center, now closed, which processed fuel cores for nuclear weapons.

Probably none of this matters a generation later, but is just nostalgia about an old communist and his predations before he got into exploiting medical mal. May he rot.”[11]

The account from Mr. Nichols certainly rings true. From years of combing over Egilman’s website (before he added password protection), anyone could see that he viewed litigation as class warfare that would advance his political goals. Litigation has the advantage of being lucrative, and bloodless, too – perfect for fair-weather Marxists.

Did Egilman remain a Marxist into the 1990s and the 21st century? Does it matter?

If Egilman was as committed to Marxist doctrine as Mr. Nichols suggests, he would have recognized that, as an expert witness, he needed to tone down his public rhetoric. Around the time I corresponded with Mr. Nichols, I saw that Egilman was presenting to the Socialist Caucus of the American Public Health Association (2012-13). Egilman always struck me as a bit too pudgy and comfortable really to yearn for a Spartan workers’ paradise. In any event, Egilman was probably not committed to the violent overthrow of the United States government because he had found a better way to destabilize our society by allying himself with the lawsuit industry. The larger point, however, is that political commitments and ideological biases are just as likely to lead to motivated reasoning, if not more so.

Although Egilman’s voice needed no amplification, he managed to turn up the wattage of his propaganda by taking over the reins, as editor in chief, of a biomedical journal. The International Journal of Occupational and Environmental Health (IJOEH) was founded and paid for by Joseph LaDou, in 1995. By 2007, Egilman had taken over as chief editor. He ran the journal out of his office, and the journal’s domain was registered in his name. Egilman published frequently in the journal, which became a vanity press for his anti-manufacturer, pro-lawsuit industry views. His editorial board included such testifying luminaries as Arthur Frank, Barry S. Levy, and David Madigan.

Douglas Starr, in an article in Science, described IJOEH as having had a reputation for opposing “mercenary science,” which is interesting given that Egilman, many on his editorial board, and many of the authors who published in IJOEH were retained, paid expert witnesses in litigation. The journal itself could not have been a better exemplar[12] of mercenary science, in support of the lawsuit industry.

In 2015, IJOEH was acquired by the Taylor & Francis publishing group, which, in short order, declined to renew Egilman’s contract to serve as editor. The new publisher also withdrew one of Egilman’s peer-reviewed papers that had been slated for publication. Taylor & Francis reported to the blog Retraction Watch that Egilman’s article had been “published inadvertently, before the review process was completed,” and was later deemed “unsuitable for publication.”[13] Egilman and his minions revolted, but Taylor & Francis held the line and retired the journal.[14]

Egilman recovered from the indignity foisted upon him by Taylor & Francis, by finding yet another journal, the Journal of Scientific Practice and Integrity (JOSPI).[15] Egilman probably said all that was needed to describe the goals of this new journal by announcing that the

Journal’s “partner” was the Collegium Ramazzini. Egilman of course was the editor in chief, with an editorial board made up of many well-known, high-volume testifiers for the lawsuit industry: Adriane Fugh-Berman, Barry Castleman, Michael R. Harbut, Peter Infante, William E. Longo, David Madigan, Gerald Markowitz, and David Rosner.

Some say that David Egilman was a force of nature, but so are hurricanes, earthquakes, volcanoes, and pestilences. You might think I have nothing good to say about David Egilman, but that is not true. The Lawsuit Industry has often organized and funded mass radiographic and other medical screenings to cull plaintiffs from the population of workers.[16] Some of these screenings led to the massive filing of fraudulent claims.[17] Although he was blind to many of the excesses of the lawsuit industry, Egilman spoke out against attorney-sponsored and funded medico-legal screenings. He published his criticisms in medical journals,[18] and he commented freely in lay media. He told one reporter that “all too often these medical screenings are little more than rackets perpetrated by money-hungry lawyers. Most workers usually don’t know what they’re getting involved in.”[19] Among the Collegium Ramazzini crowd, Egilman was pretty much a lone voice of criticism.


[1] SeeDavid Egilman’s Methodology for Divining Causation,” Tortini (Sept. 6, 2012).

[2] In re Zyprexa Injunction, 474 F.Supp. 2d 385 (E.D.N.Y. 2007). The Zyprexa case was not the first instance of Egilman’s involvement in a controversy over a protective order. Ballinger v. BrushWellman, Inc., 2001 WL 36034524 (Colo. Dist. June 22, 2001), aff’d in part and rev’d in part, 2002 WL 2027530 (Colo. App. Sept. 5, 2002) (unpublished).

[3]Doctor Who Leaked Documents Will Pay $100,000 to Lilly,” N. Y. Times (Sept. 8, 2007).

[4] William G. Childs, “When the Bell Can’t Be Unrung: Document Leaks and Protective Orders in Mass Tort Litigation,” 27 Rev. Litig. 565 (2008).

[5] Eli Lilly & Co. v. Gottstein, 617 F.3d 186, 188 (2d Cir. 2010).

[6] Michelle Dally, “The Hero Who Wound Up On the Wrong Side of the Law,” Rhode Island Monthly 37 (Nov. 2001).

[7] Douglas Starr, “Bearing Witness,” 363 Science 334 (2019).

[8] Id. at 335 (quoting Mark Lanier, who fired Egilman for his malfeasance in the Zyprexa litigation).

[9] Doctor David Egilman Project, at <https://web.archive.org/web/20130902035225/http://coppolaentertainment.com/ddep.htm>.

[10] Bill Steigerwald, “The death of a great Ohio newspaperman,” (Feb. 08, 2022) (“Dennis Nichols of Cincinnati’s eastern suburbs was a dogged, brilliant and principled journalist who ran his family’s two community papers and gave the local authorities all the trouble they deserved.); John Thebout, Village of Batavia Mayor, “Batavia Mayor remembers Dennis Nichols,” Clermont Sun (Feb. 9, 2022).

[11] Dennis Nichols email to Nathan Schachtman, re David Egilman (Mar. 9, 2013)

[12] Douglas Starr, “Bearing Witness,” 363 Science 334, 337 (2019).

[13] See Public health journal’s editorial board tells publisher they have ‘grave concerns’ over new editor,” Retraction Watch (April 27, 2017).

[14]David Egilman and Friends Circle the Wagon at the IJOEH,” Tortini (May 4, 2017).

[15] SeeA New Egilman Bully Pulpit,” Tortini (Feb. 19, 2020).

[16] Schachtman, “State Regulators Impose Sanction Unlawful Screenings 05-25-07,” Washington Legal Foundation Legal Opinion Letter, vol. 17, no. 13 (May 2007); Schachtman, “Silica Litigation – Screening, Scheming, and Suing,” Washington Legal Foundation Critical Legal Issues Working Paper (December 2005); Schachtman & Rhodes, “Medico-Legal Issues in Occupational Lung Disease Litigation,” 27 Seminars in Roentgenology 140 (1992).

[17] In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563 (S.D. Tex. 2005) (Jack, J.).

[18] See David Egilman and Susanna Rankin Bohme, “Attorney-directed screenings can be hazardous,” 45 Am. J. Indus. Med. 305 (2004); David Egilman, “Asbestos screenings,” 42 Am. J. Indus. Med. 163 (2002).

[19] Andrew Schneider, “Asbestos Lawsuits Anger Critics,” St. Louis Post-Dispatch (Feb. 11, 2003).

David Egilman RIP – Part Two

April 28th, 2024

There was a good bit of irony in Egilman’s reaching out to me to help him prepare for my deposition of him in a silicone gel breast implant case. First, the materials he apparently wanted were all in a document repository for the benefit of plaintiffs’ lawyers. He needed only to have asked the Wilentz firm lawyers for relevant. In rather typical fashion, Egilman wanted to create a faux issue about defense counsel’s hiding the ball.

Second, Egilman had already completed his report, and his request showed that his opinions had been asserted without looking at material documents.

Third, and perhaps most important, in New Jersey, attorneys are not generally allowed to communicate with a represented party directly.[1] Expert witnesses are usually considered as agents of the parties that retained them, which means that such witnesses are also not free to communicate directly with the adverse parties or its counsel. There was no exact precedent for Egilman’s misconduct, but it was obviously disturbing to plaintiffs’ counsel, who promptly withdrew Egilman as a witness in the case. Alas, I did not get my chance to conduct this examination before trial.

Much of the irony in the New Jersey situation derived from Egilman’s fancying himself  something of an ethicist. He certainly was quick to pronounce ethical judgments upon others, especially anyone in manufacturing industry, or any scientist who served as an expert witness opposite him. As he made clear at his CSPI lecture, Egilman had an ideological bias, and it deeply affected his judgment of science and history. He swam in the hogwash of critical theory, cultural hegemony, and Marxist cant.

To Egilman, it was obvious that material forces of capitalism meant that manufacturing industry was incapable of honestly defending its products. The motives, biases, and depradations of the lawsuit industry and its agents rarely concerned him. As a committed socialist, Egilman was incurious about how and why occupational and environmental diseases were so prevalent in socialist and communist countries, where profits are outlawed and the people own the means of production.[2]

Like the radical labor historians David Rosner and Gerald Markowitz, Egilman tried to cram the history of silicosis (and even silicosis litigation) into a Marxist narrative of class conflict, economic reductionism, and capitalist greed. Egilman’s ideological bias marred his attempts to relate the history of dust diseases. His bias made him a careless historian. Several of his attempts to relate the history of dust diseases were little more than recycled litigation reports, previously  filed in various cases, with footnotes added. Egilman was occasionally listed as an expert witness in silicosis cases, but he glibly and ignorantly lumped the history of silica with that of asbestos diseases. In one article, for example, he wrote:

“Knowledge that asbestos and silica were hazardous to health became public several decades after the industry knew of the health concerns. This delay was largely influenced by the interests of Metropolitan Life Insurance Company (MetLife) and other asbestos mining and product manufacturing companies.”[3]

Egilman’s claims about silica, however, were never supported in this article or elsewhere. A brief review of two published monographs by Frederick L. Hoffman, published before 1923, should be sufficient to condemn the authors’ carelessness to the dustbin of occupational history.[4]  The bibliographies in both these monographs document the widespread interest in, and awareness of, the occupational hazards of silica dusts, going back into the 19th century, among the media, the labor movement, and the non-industrial scientific community. The conversation about silicosis was on full display in the national silicosis conference of 1938, sponsored by Secretary of Labor Francis Perkins.

On at least one occasion, Egilman publicly acknowledged his own entrepreneurial and profit motives. In a consumer diacetyl exposure case (claiming bronchiolitis obliterans), a federal district court excluded Egilman’s causation opinions as unreliable. The court found that Egilman had manipulated data to reach misleading conclusions, devoid of scientific validity.[5]

Egilman was so distraught by being excluded that he sought to file a personal appeal to the United States Court of Appeal.[6] When the defendant-appellee opposed Egilman’s motion to intervene in the plaintiff’s appeal, Egilman stridently asserted his right to participate,[7] and filed his own declaration.[8] The declaration is required reading for anyone who wants to understand Egilman’s psycho-pathology.

In what was nothing short of a scurrilous pleading, Egilman attacked the district judge for having excluded him from testifying. He went so far as to claim that the judge had defamed him with derogatory comments about his “methodology.” If Egilman’s challenge to the trial judge was not bizarre enough, Egilman also claimed a right to intervene in the appeal by advancing the claim that the Rule 702 exclusion hurt his livelihood.  The following language is from paragraph 11 of Dr. Egilman’s declaration in support of his motion:

“The Daubert ruling eliminates my ability to testify in this case and in others. I will lose the opportunity to bill for services in this case and in others (although I generally donate most fees related to courtroom testimony to charitable organizations, the lack of opportunity to do so is an injury to me). Based on my experience, it is virtually certain that some lawyers will choose not to attempt to retain me as a result of this ruling. Some lawyers will be dissuaded from retaining my services because the ruling is replete with unsubstantiated pejorative attacks on my qualifications as a scientist and expert. The judge’s rejection of my opinion is primarily an ad hominem attack and not based on an actual analysis of what I said – in an effort to deflect the ad hominem nature of the attack the judge creates ‘strawman’ arguments and then knocks the strawmen down, without ever addressing the substance of my positions.”

Egilman was a bit coy about how much of his fees went to him, and how much went to charity. To give the reader some idea of the artificial flavor of Egilman’s pomposity, paragraph 8 of his remarkable declaration avers”

“My views on the scientific standards for the determination of cause-effect relationships (medical epistemology) have been cited by the Massachusetts Supreme Court (Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1 (1998)):

Although there was conflicting testimony at the Oregon hearing as to the necessity of epidemiological data to establish causation of a disease, the judge appears to have accepted the testimony of an expert epidemiologist that, in the absence of epidemiology, it is ‘sound science…. to rely on case reports, clinical studies, in vivo tests and animal tests.’ The judge may also have relied on the affidavit of the plaintiff’s epidemiological expert, Dr. David S. Egilman, who identified several examples in which disease causation has been established based on animal and clinical case studies alone to demonstrate that doctors utilize epidemiological data as one tool among many ’.”

Egilman’s quote from the Vassallo decision is accurate as far as it goes,[9] but the underlying assertion is either a lie or a grand self-delusion. There was epidemiologic evidence on silicone and connective tissue disease before the Oregon federal district court and its technical advisors, and the court resoundingly rejected the plaintiffs’ causal claims as unsupported by valid evidence, with or without epidemiologic evidence. The argument that epidemiology was unnecessary came from Dr. Egilman’s affidavit, and the plaintiffs’ counsel’s briefs, which were considered and rejected by Judge Jones.[10]

Egilman’s affidavit in connection with the so-called Oregon hearings, which took place during the summer of 1996, was not a particularly important piece of evidence. Most of the “regulars” had put in reports or affidavits in the Hall case. Egilman failed to appear at the proceedings before the court and its technical advisors; and he was not mentioned by name in the Hall decision. Nonetheless, Judge Jones, in his published decision, clearly rejected all the plaintiffs’ witnesses and affiants, including Egilman, in their efforts to make a case for silicone as a cause of autoimmune disease.

A few months after the Oregon hearings, Judge Weinstein, in the fall of 1996, along with other federal and state judges, held a “Daubert” hearing on the admissibility of expert witness opinion testimony in breast implant cases, pending in New York state and federal courts.  Egilman’s affidavit on causation was once again in play. Plaintiffs’ counsel suggested that Egilman might testify, but he was once again a no show. Egilman’s affidavit was in the record, and the multi-judge panel considered and rejected the claimed causal connection between silicone and autoimmune or connective tissue diseases.[11]

There is more, however, to the disingenuousness of Dr. Egilman’s citation to the Vassallo case.  The Newkirk court, in receiving his curious declaration, would not likely have known that Vassallo was a silicone gel breast implant case, and one may suspect that Dr. Egilman wanted to keep the Ninth Circuit uninformed of his role in the silicone litigation. After all, by 1999, The Institute of Medicine (now the National Academies of Science, Engineering, and Medicine) delivered its assessment of the safety of silicone breast implants.  Egilman’s distorted and exaggerated claims had been rejected.[12]

Alas, the jingle of coin doth not always soothe the hurt that conscience must feel. In his declaration, Egilman sought to temper the unfavorable judgment in the Newkirk diacetyl case by noting that only judges who had not previously encountered him would be unduly persuaded by Judge Peterson’s decision. Other judges who have heard him hold forth in court would no doubt see him for the brilliant crusading avenger that he is. The feared prejudice:

“will generally not occur in cases heard before Judges where I have already appeared as a witness. For example a New York state trial judge has praised plaintiffs’ molecular-biology and public-health expert Dr. David Egilman as follows: ‘Dr. Egilman is a brilliant fellow and I always enjoy seeing him and I enjoy listening to his testimony . . . . He is brilliant, he really is.’ [Lopez v. Ford Motor Co., et al. (120954/2000; In re New York City Asbestos Litigation, Index No. 40000/88).]”[13]

The United States Court of Appeals did not appear to hold Egilman the intervenor as brilliant as he thought himself. The court was not moved by either the bullying or the braggadocio.[14] The curious appeal was denied.

Egilman obviously could not sue the trial or appellate judges in the Newkirk case, but he did on other occasions try to deflect or diminish criticism by threats of litigation. In 2009, Laurence Hirsh, a physician, formerly with Merck, wrote a commentary for the Mayo Clinic Proceedings, on conflicts of interest. His commentary was a sustained critique of the hypocrisy and anti-industry bias of journals’ requirements for disclosure of conflict of interest.[15] Hirsch pointed out that some of the authors, including David Egilman, who had written articles critical of Merck, had given anemic disclosures of their own biases and conflicts of interest. Hirsch noted that Egilman had testified in many different litigations (too many diverse litigations to be credible for any one witness), including “silicone breast implants and connective tissue disease (characterized as the epitome of junk science)….”[16] With respect to compensation, Hirsch reported that:

“Egilman has testified for Mr Lanier and other attorneys in more than 100 tort cases (nearly always for plaintiffs) for approximately 2 decades and, by his own estimate, has earned $20 to $25 million for such testimony. Besides dollars, Egilman’s objectivity is questionable on other grounds. In 2007, he signed an admission that ‘there was another side to the story’ and was fined $100,000 by an outraged federal judge for actively facilitating the leak (through a third party) to a New York Times reporter (exclusively) of court-sealed documents in litigation involving Eli Lilly (Indianapolis, IN) and olanzapine (Zyprexa).”[17]

Hirsch’s commentary was a burr under the saddle of this lawsuit industry work horse. Egilman wrote to Hirsch to demand that he correct and retract his comments. Egilman threatened to sue Dr. Hirsch for false and defamatory statements. Alas, Hirsch was intimidated by the threats. The correction that resulted was shaped by Egilman’s assertions, and what resulted was false and misleading:

“1. Dr Egilman’s income from serving as a medical expert in tort litigation, etc, was incorrectly reported as $20-$25 million during a 20-year period. Dr Egilman actually testified in court that it was $2-$2.5 million during that time. The source for the original statement in the Commentary was an online newspaper article dated July 31, 2005. The newspaper revised its report of the court testimony by Dr Egilman in a correction that was published only in the local, printed edition on August 2, 2005 (Michael Morris, oral communication, September 11, 2009).

2. Dr Egilman was not fined by a judge for leaking court sealed documents concerning the Lilly-Zyprexa litigation. Rather, Dr Egilman and Lilly entered into an (Stipulated) agreement by US District Judge Jack Weinstein, filed September 9, 2007, in which Dr Egilman agreed to pay Lilly $100,000, and to dismiss his appeal of the Court’s Final Judgment, Order and Injunction from February and March, 2007 (http://lawprofessors.typepad.com/tortsprof/files/EgilmanSettlement.pdf).

3. Dr Egilman has not testified in court in breast implant and connective tissue disease, or in antidepressant or antipsychotic drug cases. Dr Egilman did provide a sworn affidavit in one case involving local effects of leakage of silicone from breast implants (Vassallo vs Baxter Healthcare Corporation. Decisions of the Supreme Judicial Court of Massachusetts. May 5-July 16, 1998, p. 7).

I regret these inaccuracies in my Commentary.”[18]

Egilman’s estimate of his income, without access to his tax returns, was essentially worthless. The difference between a fine and a stipulated penalty was meaningless. The claim that Egilman did not testify in the Vassallo trial, in which the plaintiff claimed that she had developed atypical autoimmune disease as a result of her silicone gel breast implants, was simply a lie that Egilman foisted upon Dr. Hirsch.

Falsus in uno, falsus in omnibus.


[1] See Formal Opinion 503, of the ABA’s Standing Committee on Ethics and Professional Responsibility, ABA Model Rule of Professional Conduct 4.02.

[2] See, e.g., Jie Li, Peng Yin, Haidong Wang, Lijun Wang, Jinling You, Jiangmei Liu, Yunning Liu, Wei Wang, Xiao Zhang, Piye Niu, and Maigeng Zhou, “The burden of pneumoconiosis in China – analysis Global Burden of Disease Study,” 22 BMC Pub. Health 1114 (2022); Na Wu, Chang Jiang Xue, Shiwen Yu, and Qiao Ye, “Artificial stone-associated silicosis in China: A prospective comparison with natural stone-associated silicosis,” 25 Respirology 518 (2019); Christa Schröder, Friedrich Klaus, Martin Butz, Dorothea Koppisch, and Otten Heinz, “Uranium mining in Germany: incidence of occupational diseases 1946-1999,” 75 Internat’l Arch. Occup. & Envt’l Health 235 (2002); A.G. Chebotarev, “Incidence of silicosis and the effectiveness of preventive measures at the Balei mines (1947 to 1967),” 13 Gigiena truda i professional’nye zabolevaniia 14 (1969) (in Russian); C. Hadjioloff, “The Development of Silicosis and Its Expert Evaluation as a Basis for the Rehabilitation of Silicosis Patients in Bulgaria,” 58 Medizinische Klinik 2023 (1963).

[3] David Egilman, Tess Bird, and Caroline Lee, “Dust diseases and the legacy of corporate manipulation of science and law, 20 Internat’l J. Occup. & Envt’l Health 115, 115 (2014) (emphasis added).

[4] Frederick L. Hoffman, Mortality from Respiratory Diseases in the Dusty Trades; Dep’t of Labor, Bureau of Labor Statistics (1918); The Problem of Dust Phthisis in the Granite Stone Industry, Dep’t of Labor, Bureau of Labor Statistics (1922). See also U.S. Department of Labor Bulletin No. 21, part I, National Silicosis Conference, Report on Medical Control (1938).

[5] Newkirk v. Conagra Foods, Inc., 727 F.Supp. 2d 1006 (E.D. Wash. 2010).

[6] Schachtman, “Exclusion of Dr. David Egilman in Diacetyl Case,” Tortini (June 20, 2011); “David Egilman’s Methodology for Divining Causation,” Tortini (Sept. 6, 2012).

[7] Opposition of David Egilman to Motion for Order to Show Cause re Dismissal of Appeal for Lack of Standing, in case no. 10-35667, document 7547640 (9th Cir. Nov. 16, 2010).

[8] Declaration of David Egilman, in Support of Opposition to Motion for Order to Show Cuase Why Appeal Should Not Be Dismissed for Lack of Standing, in case no. 10-35667, document 7547640 (9th Cir. Nov. 16, 2010) Declaration [Declaration].

[9] Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1, 12 (1998).

[10] See Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. 1996). Judge Jones made his views very clear:  contrary to Egilman’s affidavit, epidemiology was needed, but lacking, in the plaintiffs’ case.

[11] Transcript at p.159:7-18, from Nyitray v. Baxter Healthcare Corp., CV 93-159 (E.D.N.Y. Oct. 9, 1996) (pre-trial hearing before Judge Jack Weinstein, Justice Lobis, and Magistrate Cheryl Pollak). See In re Breast Implant Cases, 942 F. Supp. 958 (E.& S.D.N.Y. 1996) (rejecting sufficiency of plaintiffs’ causation expert witness evidence, which included affidavit of Dr. Egilman). Years later, Judge Jack B. Weinstein elaborated upon his published breast-implant decision, with a bit more detail about how he viewed the plaintiffs’ expert witnesses. Judge Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in silicone litigation as “charlatans”; “[t]he breast implant litigation was largely based on a litigation fraud. … Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”) Egilman, who had filed an affidavit in support of the plaintiffs’ claims in the Hall case, and in the cases before Judge Weinstein, was within the scope of that litigation fraud.

[12] Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (1999).

[13] Declaration at p. 9 n. 2.

[14] Newkirk v. Conagra Foods, Inc. 727 F.Supp. 2d 1006 (E.D. Wash. 2010), aff’d, 438 Fed.Appx. 607 (9th Cir.2011); Egilman v. Conagra Foods, Inc., 2012 WL 3836100 (9th Cir. 2012), cert. denied, 568 U.S. 1229 (2013).

[15] Laurence J. Hirsch, “Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals,” 84 Mayo Clin. Proc. 811 (2009).

[16] Id. at 815.

[17] Id. at 814 (internal citations omitted).

[18] Laurence J. Hirsch, “Corrections,” 85 Mayo Clin. Proc. 99 (2010).

The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.