Schachtman Law

TORTINI

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

AAAS Conference on Scientific Evidence and the Courts

September 8th, 2025

Back in September 2023, the American Association for the Advancement of Science (AAAS), with its Center for Scientific Responsibility and Justice, sponsored a two day meeting on Scientific Evidence and the Courts. If there were notices for this conference, I missed them. The meeting presentations are now available online. Judging from camera views of the audience, the conference did not appear to be well attended. Most of the material was forgettable, but some of the presentations are worth watching.

Jennifer L. Mnookin opened the conference with a keynote presentation on “Where Law and Science Meet.” Chancellor Mnookin presented a broad overview and some interesting insights on the development of the evidence law of expert witness testimony.

Following Mnookin, Professors Ronald Allen and Andrew Jurs presented on the “Unintended Impacts [sic] of the Daubert Standard.” The conference took place only a few months before amendment to Rule 702 became effective, and the reference to a “Daubert” standard was untoward. Allen’s comments followed the path of his previous articles. Jurs presented some empirical legal research, which seemed flawed for its assumption that the Frye standard was universally applied in federal court before the advent of Daubert. Assessing whether these standards lead to different outcomes when both standards have been applied heterogeneously, and one standard, Frye, is often not applied at all, and Daubert is often flyblown by judges hostile to the gatekeeping enterprise, Jurs’ empirical research seemed both invalid and very much beside the point. Both presenters missed the key point of Daubert, in which case plaintiff’s counsel advocated for no standard at all, beyond basic subject-matter qualification, for giving expert opinions in court.

A Session on “An International Perspective,” Scott Carlson discussed the efforts of the American Bar Association (ABA), and its Center of Global Programs, on supporting judges in foreign countries. Prateek Sibal discussed the history and work of the UNESCO Global Judges Initiative. My sincere wish is that the ABA would support judges more in the United States.

Panelists Valerie P. Hans, Emily Murphy, and Dr. Michael J. Saks presented on various jury issues, in a session “In the Minds of the Jury.” The presentations on how foreign countries process expert witness testimony were lacking any mention of how juries rarely if ever sit in civil cases that involve complex technical and scientific issues.

Two editors of scientific journals, Adriana Bankston and Valda Vinson, along with law professor Michael Sakes, spoke about peer review and publication, in a session “As a Matter of Fact: ‘General Acceptance’ in Emerging vs. Established Science.” Their discussion on the publication process shed very little light on how courts and juries should assess the validity of specific papers, particularly in view of the lax practices at many journals. Towards the end of this session, a question from the audience proved to be very revealing of the prejudices of the law professor on the panel. The questioner rose to complain that after beginning research on a topic that has litigation relevance her research is now frequently questioned. She asked the panel how she might deal with the annoyance of being questioned. Some on the panel basically urged her to buck up, but the law professor invoked the spirit of agnothologist, and lawsuit industry expert witness, David Michael, to suggest that “manufacturing doubt” was just a corporate tactic in the face of scientific evidence. The prejudice against corporate speech is remarkable when the lawsuit industry has a long history of playing the ad hominem game in advancing its pecuniary interests.

The session that followed addressed how trustworthy science might best be put before courts. The organizers described this session, Utilizing Scientific and Technical Expertise, as going to the heart of the issues targeted by the conference. Joe S. Cecil, Deanne M. Ottaviano, and Shari Seidman Diamond discussed how scientific expertise enters into the evidentiary record in American courtrooms. Their presentations were interesting, but curiously no one mentioned that the primary avenue for expert witness opinion is through oral testimony!

Joe Cecil discussed methods judges have to obtain scientific and technical evidence to advance justice. (By this I hope he meant the truth, and not just the outcome preferred by social justice warriors.) As noted, Joe Cecil did not focus on the ordinary methods of direct and cross-examination of party expert witnesses, but rather, he identified other methods of introducing expertise into the courtroom for the benefit of the judge or the jury. Only one suggestion really affects jury comprehension, namely the appointment of non-party expert witnesses by the court. The other methods really only provide expertise to the trial judge, who perhaps is challenged to make a ruling under Federal Rule of Evidence 702. The federal courts have the inherent supervisory power to appoint technical advisors to act as special law clerks on issues. Similarly, appointed special masters can address technical implementation issues, subject to the district judges’ control. The judges are always free to read outside the briefs and testimony, but there are ethical and notice issues for such conduct. The Reference Manual on Scientific Evidence (RMSE) sits on the shelves on every federal judge’s bookshelf, even if in pristine, unused condition. Judges can at least read the RMSE on specific issues without having to disclose their extra-curricular research to the parties. Of course, parties are well advised to consider any materials in the RMSE, which support or oppose their contentions.

In discussing the RMSE, Cecil noted that the fourth edition was in the works. He also mentioned that all the old chapter topics would be carried forward to the fourth edition, and that new topics would include eyewitness identification, computer science, artificial intelligence, and climate science. Sadly, there will be no chapter on genetic determination of disease, but perhaps the clinical medicine chapter will take on the subject in greater detail than previous editions. This conference took place two years ago, and yet the RMSE, fourth edition, is still not published. The National Academies website previously listed the project as completed, but the site now describes the work as “in progress.”

Joe Cecil’s analysis of the various extraordinary expert techniques was pretty much spot on, especially his assessment that “experiments” with court-appointed experts were often failures or at best modest successes. The discussion of Judge Pointer’s Rule 706 independent expert witnesses in the silicon [sic] breast implant litigation, MDL926, seemed to lack context. Cecil acknowledged that the court’s expert witnesses contributed some value to admissibility decisions, but Judge Pointer notoriously did not believe that he, as the MDL judge, had any responsibility for Rule 702 determinations, and he made none except in cases that he tried in the Northern District of Alabama. (And these decisions were before the Science Panel was appointed.) So the Rule 706 witnesses really could not have aided in admissibility decisions.

The real value – in my view – of the Science Panel was that it demonstrated that Judge Pointer was quite wrong in believing that both sides’ expert witnesses were simply “too extreme,” or too partisan, and that the truth was somehow in the middle. Indeed, Judge Pointer said so on many occasions, and he was judicially gobsmacked when all four of his experts roundly rejected the plaintiffs’ distortions of the science of immunology, epidemiology, toxicology, and rheumatology. The courts’ expert witnesses sat for discovery depositions, and then gave testimony de bene esse. To my knowledge, their testimony was never admitted in any of the subsequent trials.

Judge Jed Rakoff gave an interesting presentation, “Strengthening Cooperation Between the Scientific Enterprise and the Justice System,” on the intersection between scientific and legal expertise and the need for their better integration. Judge Rakoff focused on the astonishing lack of compliance of trial judges with the gatekeeping requirements of Rule 702 in addressing the admissibility of forensic evidence. Several subsequent panels also addressed forensic topics, including “A Texas Case Study in Accountability for Forensic Sciences,” “Innovations in Investigative Technologies Improvements and Drawbacks,” and “Artificial Intelligence and the Courts,” “Wrongful Convictions and Changed Science: Statutes,” and “Standing Up for Justice: When the Law and Science Work Hand-in-Hand.”

One of the more curious sessions was on “Statistical Modeling and Causation Science,” presented by the American Statistical Association along with the AAAS. Maria Cuellar, from the University of Pennsylvania, discussed the role of statistical thinking in causal assessment, with slides that referred to a nonparametric estimator for the probability of causation. Cuellar, however, never defined what an estimator was; nor did she differentiate nonparametric from parametric estimators. She displayed other equations, again without explaining their origin and meaning, or identifying symbols or meanings. Similarly, Rochelle E. Tractenberg, discussed the use of statistics as evidence and as part of inferring causal inference in litigation, in a model of unclarity. At one point, Tractenberg appeared to suggest that general causation could be taken from regulatory pronouncements. Her discussion of glyphosate implied that general causation was established, which may have led me to disregard her presentation.

Finally, the conference sported a discussion, “Toxic Tort 2.0: Emerging Trends in Climate Change Related Litigation,” The two presenters were Dr. L. Delta Merner, the “Lead Scientist” for the Science Hub for Climate Litigation, Union of Concerned Scientists, and Dr. Paul A. Hanle, Visiting Scholar and Founder of the Climate Judiciary Project, Environmental Law Institute. The Science Hub actively promotes climate change litigation, which made me wonder whether its scientists are involved in that new chapter in the upcoming fourth edition of the Reference Manual.

Posted in Causation, Reference Manual on Scientific Evidence, Rule 702, Scientific Evidence, Scientific Publishing | 6 Comments »

Lack of Trust in Science – The Situation Our Situation Is In

August 29th, 2025

The United States is in political crisis as its citizens are frogmarched into an authoritarian, illiberal, and unlawful dystopia. The seriousness of the political situation makes it difficult to focus on scientific issues, but as with past fascist regimes in history, the crisis is not limited to any one sphere of life in the United States.

Scholars of fascism have pointed out that not all fascist regimes are the same, but there are some key features that give them all a family resemblance. In the political realm, fascist leaders point to an idyllic history, however mythical or false, in which the country was once great. The greatness has been eroded and squandered by the country’s enemies, internal and external. Confronting enemies within and without is an emergency, which cannot be addressed within the rule of law. Only an authoritarian leader can fix it by suspending the rule of law.

Fascism does not operate solely in the political sphere, but insists upon ideological purity in art, culture, education, business, finance, military, law, and science.[1]

Yes, even science. Nazi Germany had its bogus science of racial purity. The Soviet Union had its Lysenkoism. Theocratic fascist regimes, such as Iran or the United States, have their “god talk” and blasphemy squads, which suppress scientific curiosity, experimentation, and development, except for the creation of weapons (where replicability, validity, and predictive accuracy really matter).

There are various reasons for Felonious Trump’s election, but the epistemic sin of credulousness of the American people is certainly one of them. We are living in Orwell’s 1984 world where many people have been tethered to TV screens to receive their daily influx of state-approved propaganda. Character for truth has ceased to be a virtue. “And even truth can become a lie in the mouth of a born liar.”[2]

The credulity of the American people has manifested as distrust in scientific expertise and willingness to believe charlatans such as Robert Kennedy, Jr. The phenomenon of transferring trust from legitimate scientists to charlatans is probably one of the clearest and strongest symptom of our current malaise.

Professor Arthur L. Caplan[3] is a scientist and medical ethicist who has never been shy about asking discomforting questions. Not surprisingly, Caplan has spoken out against some of the bone-headed anti-science actions of the present regime in Washington.[4]

In an essay entitled “How Stupid has Science Been?” Caplan asks:

“So how can U.S. President Trump, Secretary of Health Robert F. Kennedy, Jr., or Director of the Centers for Medicare and Medicaid Mehmet Oz and their enthusiastic followers be succeeding in defunding research and installing ideological oversight and censorship that is crushing science, technology and engineering and will for many years to come?”[5]

Caplan blames the scientific community itself, in part, for the current crisis by disparaging and discouraging scientists from engaging with the public. Obviously, Caplan is not thinking of the cadre of scientists who seek phony validation by becoming highly paid expert witnesses for the lawsuit industry. Nor is he thinking of the dodgy TV doctors such as Dr. Oz. Caplan’s focus is on the harm done to the careers of accomplished scientists, such as the late Carl Sagan, who was denied tenure at Harvard University and membership in the National Academies of Science because his popularizing efforts eclipsed his substantial scientific accomplishments. Caplan thus blames the American scientific establishment itself for having “disparaged its public communication as unnecessary and looked down on those few who tried to educate broader audiences about the wonders, benefits, methods and advancements of science.”

Professor Caplan argues that in popularizing scientific ideas, theories, and methods, scientists – such as the late Carl Sagan – undermined their own careers. The result is that high-achieving scientists ignored the public square and retreated into their own scientific community’s ivory tower. Caplan’s critique of the detachment of the scientific community could well be extended to its frequent failures to speak out against charlatans in its own midsts, and politicians who distort and misrepresent scientific research in the public arena.

Caplan is, however, very clear that the scientific community’s insularity, and its “resulting failure to communicate about science to the public is a major factor in explaining why so few have rallied to science’s defense today against government policies promoting ignorance, illiteracy and quackery.” Indeed, although at this point, it is also clear that frank communications about the government’s promotion of scientific quackery will be punished by the Regime’s cancellation of grants, firing from advisory councils, and retaliations against scientists’ universities.

I take Caplan’s critique to be an invitation to engage in counter-factual thinking about what our current situation might look like if scientists had robustly “occupied the field” of communication and education of the public. Citing a recent article in a Nature journal,[6] Caplan observes that populists and right-wing thinkers have been losing faith in science for years. This diagnosis, however, is not quite accurate. Populists, left and right, have succumbed to motivated reasoning in learning to ignore scientific conclusions, regardless of validity concerns, on emotive or political grounds. This mode of (non)-thinking allows populists, left and right, to subscribe to putative scientific claims without any appreciation of the nuances of scientific inference and threats to validity.

Caplan is right to call out the right-wing attack on science, but some of the attack on science is coming from left-wing populists, such as the worm-brained Robert F. Kennedy, Jr. And historically, there have been many instances in which environmental and occupational health advocates have outrun their headlights to press claims based upon hypothetical models and unvalidated assumptions.

All people, whether they hang politically left or right, are vulnerable to the emperor of all cognitive biases – apophenia, the psychological tendency to discern causal patterns in random noise. Although apophenia was originally thought of an abnormal psychological process,[7] the phenomenon is common to “normal” as well as mentally ill persons.[8]

Many people, left and right, are willing to endorse, or subscribe to, pseudo-scientific claims based upon their motivations to accept claims, without regard to the methods used to support those claims. Professor Caplan is correct that serious scientists have been too shy to step into the public square, and the scientific community should encourage, not punish, engagement with the public. (Caplan passes over the problem of how university publicists often misrepresent and exaggerate the findings and research of university scientists.)

The problem of lack of trust in science, however, is a much bigger problem. On average, American education and acumen in math and science lags that of many countries in the world,[9] even as post-secondary education in the United States excels and attracts many of the best and the brightest domestically and internationally. Immigrants have helped American universities keep their leadership role in the world, despite shortfalls in domestic funding of primary and secondary science education. Of course, this international leadership in science and math university education, gained with the help of immigrants, is now under attack from the MAGAT regime.[10]

No one is eager to blame those who evidence their lack of trust in science, and to be sure, there is plenty of blame to go around. There are multiple systemic causes of poor quality science and improvident claims to scientific knowledge.[11] In assessing the causes of the prevalent distrust in science, we should not lose sight of the responsibility of those who claim that scientists cannot be trusted. There is at bottom a widespread moral failure in the land. “It is wrong always, everywhere, and for anyone, to believe anything upon insufficient evidence.”[12]

доверяй, но проверяй!

[1] Zachary Basu, “Trump knee-caps America’s institutions,” Axios (Aug. 27, 2025); Elisabeth Zerofsky, “Robert Paxton, A Leading Historian Of Fascism, Long Resisted Applying The Label To Trumpism. Then He Changed His Mind..,” N.Y. Times Mag. 45 (Oct. 27, 2024).

[2] Thomas Mann, “The Problem of Freedom: An Address to the Undergraduates and Faculty of Rutgers University at Convocation,” (April 28, 1939).

[3] Arthur L. Caplan, PhD., is the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics, Department of Population Health, and the founder of the Division of Medical Ethics at NYU Grossman School of Medicine’s Department of Population Health in New York City. I had the pleasure to meet Professor Caplan, and present to one of his classes, back when he taught at the University of Pennsylvania.

[4] See, e.g., Arthur L. Caplan, “Fed Action Toward Medical Journals Is ‘Dangerous’, Ethicist Says,” Medscape (Aug. 26, 2025).

[5] Arthur L. Caplan, entitled “How Stupid has Science Been?” EMBO reports (Aug. 2025).

[6] Vukašin Gligorić, Gerben A. van Kleef, and Bastiaan T. Rutjens, “Political ideology and trust in scientists in the USA,” 9 Nature Human Behaviour 1501 (2025) (“Since the 1980s, trust of science among conservatives in America has been plummeting”).

[7] See Aaron L Mishara, “Klaus Conrad (1905–1961): Delusional Mood, Psychosis, and Beginning Schizophrenia,” 36 Schizophr Bull. 9 (2009); Scott D. Blain, Julia M. Longenecker, Rachael G. Grazioplene, Bonnie Klimes-Dougan, and Colin G. DeYoung, “Apophenia as the disposition to false positives: A unifying framework for openness and psychoticism,” 129 J. Abnormal Psych. 279 (2020).

[8] Donna L Roberts, “Apophenia: The Human Tendency to Find Patterns in Randomness,” Medium (Jan. 9, 2024); Ahmed S. Sultan & Maryam Jessri, “Pathology is Always Around Us: Apophenia in Pathology, a Remarkable Unreported Phenomenon,” 7 Diseases 54 (2019).

[9] Drew DeSilver, “U.S. students’ academic achievement still lags that of their peers in many other countries,” Pew Research Center (Feb. 15, 2017).

[10] Is it not high time that we call the movement by its essential motivation: make American great again for the Trumps?

[11] See, e.g., Lex Bouter, Mai Har Sham & Sabine Kleinert, “The Lancet–World Conferences on Research Integrity Foundation Commission on Research Integrity,” 406 The Lancet 896 (2025).

[12] William K. Clifford, “The Ethics of Belief,” 29 Contemporary Rev. 289, 295 (1877).

Posted in Causation, Cognitive Biases, Scientific Evidence, Scientific Misconduct | No Comments »

Junk Journalism

August 19th, 2025

There is plenty of room for a healthy science-based environmentalism, but finding the room in the American political house has always been difficult. The current administration brings together the horseshoe wacko excesses of the worm-brained Robert Kennedy, Jr., and the crony capitalism of Felonious Trump. In this toxic, post-truth milieu, environmental groups such as Sierra Club and Greenpeace are both complaining about their setbacks,[1] as well as stepping up their own propaganda.

In the face of advocacy group propaganda, journalists should provide a strong science filter before allowing misinformation and emotive appeals to be passed off as scientific truth. Sadly, well-motivated manufacturing industry can rarely count on either the main stream media for sympathy or accuracy in reporting environmental issues. Readers of major newspapers, however, deserve careful reporting and the separation from hyperbole and fact.

A recent article in the Washington Post makes the point. Activist journalist Amudalat Ajasa reported her story this week that “Her dogs kept dying, and she got cancer. Then they tested her water.”[2] Oh my goodness; that must be a scandal; right? Queue the outrage.

Now widespread journalistic practice means that Ms. Ajasa may not have written the headline, and it was likely an editor who concocted the click-bait headline that suggested that something in the water killed some woman’s dogs and caused her cancer. Upon reading the story, however, readers would be justified in concluding that the author was clearly in on the ploy to misinform. So shame on both the would-be journalist and her editor.

Ms. Ajasa tells us that the residents of Elkton, Maryland, worry about “forever chemicals” in their water, a worry instigated in large measure by mass and social media, advocacy NGOs, state and federal agencies, and the lawsuit industry. Focusing on her anecdotal datum, Ajasa reports that Ms. Debbie Blankenship, a resident of the Elkton area, had “chalked up her health problems, including losing her right leg to an infection, to bad luck.” Bad luck? Ajasa must have gotten a HIPAA release and waiver to discuss Ms. Blankenship’s medical condition in a very public forum because the WaPo story discusses health details and features photographs of Ms. Blankenship, who is clearly obese, has had one leg amputated, and is confined to a wheel chair. Apparently, neither Ms. Blankenship nor Ms. Ajasa ever considered that lifestyle factors combined to cause Ms. Blankenship to develop diabetes mellitus and cancer (of some unspecified type).

The obvious, however, is ignored or pushed aside by Ajasa’s reporting that in 2023, W.L. Gore & Associates, a manufacturer of Gore-Tex, telephoned with a request to test the Blankenship water well for perfluorooctanoic acid (PFOA), which had been used in its manufacture of Teflon (polytetrafluoroethylene or PFTE). PFOA is one of the family of PFAS chemicals that has been the subject of a regulatory furor in recent years, including the issuance of action levels below the limits of detection for many laboratories.

The request to test the Blankenship water well was triggered by a lawsuit, filed in 2022, by a former W.L. Gore employee, Stephen Sutton. The lawsuit industry jumped on Sutton’s lawsuit with a class action environmental complaint in 2024. In any event, according to Ms. Ajasa, the company’s request to test the Blankenship well led to the eureka moment of scientific insight. Ms. Blankenship and her dogs drank well water, but her husband and children always drank bottled water. She was poisoned by the well water. Quod erat demonstrandum!

Ajasa’s reporting forces the reader to wade through a lot of activist propaganda and scientific hooey, such as claims that there is no safe level of PFOA, passed off as scientific fact. Agency assumptions and precautionary principle statements are not facts. Ignorance about no observable effect level is not knowledge that there is no safe level.

The WaPo readers are similarly regaled with a claim, masquerading as a statement of fact, that PFAS chemicals have “been linked to serious health problems including high cholesterol, cardiovascular disease, infertility, low birth weight and certain cancers.” Use of the verb “link” is a meaningless term in science, and thus a favorite of sloppy journalists. Whether a link is an association, a cause, a suggestion from an anecdote, a lawyer’s allegation, or a claim by an environmental group is anyone’s guess, and is left to the reader’s imagination. Whether Ms. Blankenship’s cancer is one of the “certain cancers” is not reported. Sloppy journalism of this sort, whether intentional, reckless, or negligent, undermines evidence-based legislation, regulation, and adjudication. “The credulous man is father to the liar and the cheat.”[3]

Ms. Ajasa eventually gets around to telling her readers that the water samples from Ms. Blankenship’s well contained PFOA concentrations of 3.4 parts per trillion (ppt), below the Environmental Protection Agency’s precautionary and unsupported maximum action level of 4 ppt. Rather than looking for other potential causes of Ms. Blankenship’s health problems, Ms. Ajasa glibly channels the EPA’s unsupported assertions that “that small amounts of the chemical can cause serious health impacts [sic], including cancer.” The reader is left to believe that this is a fact and that the undefined “small amounts” must include the 3.4 ppt detected in Blankenship’s well. Ajasa uses innuendo to substitute for the absence of evidence.

Journalists have an important role in informing and educating the public about scientific issues and controversies. Innuendo, unquestioned assumptions, and sloppy thinking – this is how the junk journalism sausage is made. Junk journalism is much like junk science. If we understand that junk journalism is a form of information pollution, then a well-considered, evidence-based environmentalism calls for remediation.

[1] David Gelles, Claire Brown and Karen Zraick, “Environmental Groups Face ‘Generational’ Setbacks Under Trump,” N.Y. Times (Aug. 16, 2025). The list of aggrieved seems endless: Sierra Club, Greenpeace, Climate and Communities Institute, Natural Resources Defense Council, Earthjustice, the Southern Environmental Law Center, etc.

[2] Amudalat Ajasa, “Her dogs kept dying, and she got cancer. Then they tested her water,” Wash. Post (Aug. 14, 2025).

[3] William Kingdon Clifford, “The Ethics of Belief” (1877), in Leslie Stephen & Sir Frederick Pollock, eds., The Ethics of Belief and Other Essays 70, 77 (1947).

Posted in Causation, Regulation, Scientific Evidence, Scientific Publishing | No Comments »

Victor Schwartz – An Intellectual Leader of the American Defense Bar

August 8th, 2025

Victor Elliot Schwartz died late last month. His passing was marked with several obituaries, from his colleagues, friends, and family, which marked his many achievements.[1] At the defense bar, Victor was truly a thought leader and tort scholar, as well as an advocate for sensible reform. Victor’s work had tremendous influence, although sadly, because of a rapacious, rent-seeking lawsuit industry, not as much influence as it should have had.

His work and insights inspired my own efforts on several fronts. Just as I was coming out of my clerkship, Victor published a law review article, in the University of Cincinnati Law Review, on the often otiose warnings required for products and raw materials sold for use in the workplace of large manufacturing concerns.[2] The learning of Victor’s scholarship became essential in fashioning a defense to dozens of silicosis cases filed in western Pennsylvania, in the early 1980s. The pursuer was a law firm that hoped to exploit the usual David-Goliath narrative from its asbestos cases, coming out of the large U.S. Steel and Bethlehem Steel factories and foundries. Victor’s work emphasized the importance of the epistemic context of occupational exposures cases that arose from employment in factories owned by sophisticated users and purchasers of potentially hazardous materials. Along with my co-defense counsel, we implemented Victor’s insights in the Cambria County, Pennsylvania, silicosis litigation. When the dust settled, the pursuer and his clients went away empty handed.[3]

Victor’s insights into the law and communication theory were equally valuable in asbestos litigation. Because most cases in Philadelphia were tried through the cockamamie reverse-bifurcation procedure, the defense rarely got a chance to put on a state-of-the-art or sophisticated intermediary defense. There was one blessed judge, the Hon. Levan Gordon, who distained reverse bifurcation, and gave me the opening to present both defenses in response to plaintiffs’ counsel’s insistence upon trying negligence and punitive damage claims in an all-issue case. Although I had the weaker side of the medical dispute, my adversary turned the case into a passion play on failure to warn. The jury returned a no cause verdict for the defense, without reaching the medical claim.[4]

Some years later, I was invited by the National Industrial Sand Association to talk about the recrudescence of silicosis litigation. The sand mining companies were very concerned about the bogus radiographic screenings and liability claims. Victor was also invited, but as things turned out, I spoke first. As a young brash lawyer, I thought I should include some concrete recommendations on what the companies could do to avoid liability. I suggested that they ask for indemnifications for any third-party suits by the buyers’ employees. I acknowledged that this was a tough ask so I had a fall-back suggestion that the firms put in recitations in the sales documents that the buyer warrants and represents that it is conversant with all pertinent regulations and industrial hygiene procedures to handle silica sand safely in its business. The audience, made up of owners and executives, was clearly uncomfortable over the suggestion that they request such concessions from their buyers in a highly competitive market. The comments were hostile, but Victor jumped in, and said that he had planned to offer the same suggestions and that the sand companies should take these suggestions very seriously. Victor had the gray hair and the gravitas that I lacked, and the company executives piped down and I got on with my talk.

Victor was a natural, and as a young lawyer, he was one of my leading role models. Years later, he encouraged me to seek membership in the American Law Institute, and offered helpful guidance about the application process. More recently, when the directors of the Center for Truth in Science wanted to create a legal advisory council, Victor Schwartz was our number one recruit. He will be missed.

[1] “Shook Mourns the Passing of Beloved Public Policy Chair Victor Schwartz,” SHB (Jul. 29, 2025); PR Newswire (Jul. 29, 2025); Legacy.com (Jul. 29, 2025)

[2] Victor E. Schwartz & Russell W. Driver, “Warnings in the Workplace: The Need for a Synthesis of Law and Communication Theory,” 52 U. Cin. L. Rev. 38 (1983). See also Victor E. Schwartz, Mark A. Behrens & Andrew W. Crouse, “Getting the Sand Out of the Eyes of the Law: The Need for a Clear Rule for Sand Suppliers in Texas After Humble Sand & Gravel, Inc. v. Gomez,” 37 St. Mary’s Law J. 283 (2006).

[3] Phillips v. A.P. Green Co., 428 Pa. Super. 167, 630 A.2d 874 (1993) (citing Schwartz & Driver), aff’d on other grounds sub nom. Phillips v. A-Best Products Co., 542 Pa. 124, 665 A.2d 1167 (1995) (citing lack of proximate cause between failure to warn and harm); Smith v. Walter C. Best, Inc., 927 F.2d 736 (3rd Cir. 1990) (Ohio law); Goodbar v. Whitehead Bros., 591 F. Supp. 552 (W.D.Va. 1984) (citing Schwartz & Driver), aff’d sub nom. Beale v. Hardy, 769 F.2d 213 (4th Cir. 1985). See Schachtman, “History of Silicosis Litigation,” Tortini (Jan. 31, 2019).

[4] O’Donnell v. The Celotex Corp., Phila. Cty. Ct.C.P., July 1982 Term, Case. No. 1619 (trial before Hon. Levan Gordon, and a jury; May 1989) (defense verdict in case in which plaintiffs presented negligence claims and defendants presented extensive evidence of federal government’s superior knowledge of hazard and control of workplace). See Schachtman, “Asbestos and Asbestos Litigation Are Forever,” Tortini (Sep. 16, 2014); “Divine Intervention in Litigation,” Torinti (Jan. 27, 2018).

Posted in Learned and sophisticated intermediary, Silica | No Comments »

Systematic Reviews versus Expert Witness Reports

July 2nd, 2025

Back in November 2024, I posted that the fourth edition of the Reference Manual on Scientific Evidence was completed, and that its publication was imminent. I based my prediction upon the National Academies’ website that reported that the project had been completed. Alas, when no Manual was forth coming, I checked back, and the project was, and is as of today, marked as “in progress.” The NASEM website provides no explanation for the retrograde movement. Could the Manual have been DOGE’d? Did Robert F. Kennedy Jr. insist that a chapter on miasma theory be added?

Ever since the third edition of the Manual arrived, I have tried to identify its strengths and weaknesses, and to highlight topics and coverage that should be improved in the next edition. In 2023, knowing that people were working on submissions for the fourth edition, I posted a series of desiderata for the new edition.[1] I might well have extended the desiderata, but I thought that work was close to completion.

One gaping omission in the third edition of the Manual, which I did not address, is the dearth of coverage of the synthesis of data and evidence across studies. To be sure, the chapter on medical testimony does discuss the “hierarchy of medical evidence, and places the systematic review at the apex.[2] The chapter on epidemiology, however, fails to discuss systematic reviews in a meaningful way, and treats meta-analysis, which ideally pre-supposes a systematic review, with some hostility and neglect.[3]

Notwithstanding the glaring omission in the 2011 version of the Reference Manual, the legal academy had been otherwise well aware of the importance of properly conducted systematic reviews. Back in 2006, Professor Margaret Berger organized a symposia on law and science, at which John Ioannidis presented on the importance of systematic reviews.[4] Lisa Bero also presented on systematic reviews and meta-analyses, and identified a significant source of bias in such reviews that results when authors limit their citations to studies that support their pre-selected, preferred conclusion.[5] Bero’s contribution, however, missed the point that a well-conducted systematic review makes cherry picking much more difficult, as well as obvious to the reader.

The high prevalence of biased citation and consideration of, and reliance upon, studies is a major source of methodological error in courtroom proceedings. Even when the studies relied upon are reasonably well done, expert witnesses can manipulate the evidentiary display through biased selection and exclusion of what to present in support of their opinions. Sometimes astute judges recognize and bar expert witnesses who would pass off their opinions, as well considered, when they are propped up only by biased citation. Unfortunately, courts have not always been vigilant and willing to exclude expert witnesses who proffer biased, invalid opinions based upon cherry-picked evidence.[6] Given that cherry picking or “biased citation” is recognized in the professional community as rather serious methodological sins, judges may be astonished to learn that both phrases, “cherry picking” and “biased citation” do not appear in the third edition of the Reference Manual on Scientific Evidence. With the delay in publishing the fourth edition, there is still time to add citations to careful debunking of biased citation, such as the reverse-engineered systematic review and meta-analysis in last year’s decision in the paraquat parkinsonism litigation.[7]

When I began my courtroom career, systematic reviews of the evidence for a causal claim were virtually non-existent. Most reviews and textbook chapters were hipshots that identified a few studies that supported the author’s preferred opinion, with perhaps a few disparaging words about a study that contradicted the author’s preferred outcome. On a controversial issue, lawyers could generally find a textbook or review article on either side of an issue. Cross-examination on a so-called “learned treatise,” however, was limited. In state courts, the learned treatise was not admissible for its truth, but only to show that expert witnesses should not be believed when they disagreed with the statement. It was all too easy for an expert witness to declare, “yes, I disagree with that one sentence, on one page, out of 1,500 pages, in that one book.”

In federal courts, the applicable rule of evidence makes the learned treatise statement admissible for its truth:

“Rule 803. Exceptions to the Rule Against Hearsay

The following are not excluded by the rule against hearsay, regardless of whether the declarant is available as a witness:

(18) Statements in Learned Treatises, Periodicals, or Pamphlets . A statement contained in a treatise, periodical, or pamphlet if:

(A) the statement is called to the attention of an expert witness on cross-examination or relied on by the expert on direct examination; and

(B) the publication is established as a reliable authority by the expert’s admission or testimony, by another expert’s testimony, or by judicial notice.

If admitted, the statement may be read into evidence but not received as an exhibit.”

While this rule historically had some importance in showing the finder of fact that the opinion given in court was not shared with the relevant expert community, the rule was and is problematic. Exactly what counts as “learned” is undefined. Expert witnesses on either side can simply endorse a treatise, a periodical, or a pamphlet as learned to enable a lawyer to use it on direct or cross-examination, and make its contents admissible. The rule was drafted and enacted in 1975, when another rule, Rule 702, was generally interpreted to place no epistemic restraints upon expert witnesses. Allowing Rule 803(18) to be invoked without the epistemic constraints of Rules 702 and 703 raised few concerns in 1975, but in the aftermath of Daubert (1993), the tension within the Federal Rules of Evidence requires that the admissibility of a statement in a learned treatise cannot save an expert witness opinion that is not otherwise sufficiently grounded and valid.[8]

Systematic reviews are a different kettle of fish from the sort of textbook opinions of the 1970s and 1980s, which often lacked comprehensive assessments and consistent application of criteria for validity. The intersection of the evolution of Rule 702 and systematic reviews is remarkable. When Rule 702 was drafted, systematic reviews were non-existent. When the Supreme Court decided the Daubert case in 1993, systematic reviews were just emerging as a different and superior form of evidence synthesis.[9] The lesson for judges, regulators, and lawyers is that the standards for valid synthesis of studies and lines of evidence have changed and become more demanding.

In 2009, several professional groups produced an important guidance for reporting systematic reviews, “the Preferred Reporting Items for Systematic reviews and Meta-Analyses,” or PRISMA.[10] Although the PRISMA guidance ostensibly addresses reporting, if authors have not done something that should be reported, their failure to do it and report about it can be identified as a significant omission from their publication. One of the PRISMA specifications called for the writing of a protocol for any systematic review, and for making this protocol available to the scientific community and the public. The protocol will identify the exact clinical issue under review, the kinds of evidence that bear on the issue, and criteria for including or excluding studies that should be included in the review. The requirement of pre-registration has the ability to damp down data dredging in observational studies and experiments, and to help readers see when authors reverse engineered systematic reviews by declaring their criteria for inclusion and exclusion after reading candidate studies and their conclusions.

In 2011, the Centre for Reviews and Dissemination, at the University of York in England, developed an internet archive, PROSPERO, for prospectively registering systematic reviews. In addition to reducing duplication of systematic reviews, PROSPERO aimed to increase transparency, validity, and integrity of the systematic reviews. Around the same time, the Center for Open Science, also set up a web-based archive for systematic review protocols.[11]

Reviews purporting to be systematic are now commonplace. By 2018, ROSPERO had registered over 30,000 records, but of course, some scientists may have registered systematic reviews which they never completed.[12] Despite the publication of professional guidances, carefully performed systematic reviews can still be hard to find.[13]

In federal court, expert witnesses must proffer their opinions in a specified form. Back in the 1980s, federal court practice on expert witnesses was “loose” not only on admissibility issues, but also on the requirements for pre-trial disclosure of opinions. In some federal districts, such as those within Pennsylvania, federal judges took their cues not from the language of the Federal Rules of Civil Procedure, but from state court practice, which required only cursory disclosure of top-level opinions without identifying all facts and data relied upon by the proposed expert witness. In many state courts, and in some federal judicial districts, lawyers had a difficulty obtaining judicial authorization to conduct examinations before trial to discover all the bases and reasoning (if any) behind an expert witness’s opinion. Under the current version of the Federal Rules of Civil Procedure, trial by ambush has generally given way to full discovery. The current version of Rule 26 provides:

Rule 26. Duty to Disclose; General Provisions Governing Discovery

(a) Required Disclosures.

* * *

(2) Disclosure of Expert Testimony.

(A) In General. In addition to the disclosures required by Rule 26(a)(1) , a party must disclose to the other parties the identity of any witness it may use at trial to present evidence under Federal Rule of Evidence 702 , 703 , or 705 .

(B) Witnesses Who Must Provide a Written Report. Unless otherwise stipulated or ordered by the court, this disclosure must be accompanied by a written report—prepared and signed by the witness—if the witness is one retained or specially employed to provide expert testimony in the case or one whose duties as the party’s employee regularly involve giving expert testimony. The report must contain:

(i) a complete statement of all opinions the witness will express and the basis and reasons for them;

(ii) the facts or data considered by the witness in forming them;

(iii) any exhibits that will be used to summarize or support them;

(iv) the witness’s qualifications, including a list of all publications authored in the previous 10 years;

(v) a list of all other cases in which, during the previous 4 years, the witness testified as an expert at trial or by deposition; and

(vi) a statement of the compensation to be paid for the study and testimony in the case.

An expert’s report or disclosure under Rule 26 remains a far cry from a systematic review, but the Rule goes a long way towards eliminating trial by ambush and surprise in requiring a complete statement of all opinions, all the bases and reasons for the opinions, and all the facts or data considered in reaching the opinions. The requirements of Rule 26, combined with a mandatory oral deposition, go a long way to help reveal cherry picking and motivated reasoning in an expert witness’s opinions.

[1] Schachtman, “Reference Manual – Desiderata for 4th Edition – Part I – Signature Diseases,” Tortini (Jan. 30, 2023); “Reference Manual – Desiderata for 4th Edition – Part II – Epidemiology & Specific Causation,” Tortini (Jan. 31, 2023); “Reference Manual – Desiderata for 4th Edition – Part III – Differential Etiology,” Tortini (Feb. 1, 2023); “Reference Manual – Desiderata for 4th Edition – Part IV – Confidence Intervals,” Tortini (Feb. 10, 2023); “Reference Manual – Desiderata for 4th Edition – Part V – Specific Tortogens,” Tortini (Feb. 14, 2023); “Reference Manual – Desiderata for 4th Edition – Part VI – Rule 703,” Tortini (Feb. 17, 2023).

[2] See John B. Wong, Lawrence O. Gostin, and Oscar A. Cabrera, “Reference Guide on Medical Testimony,” in Reference Manual on Scientific Evidence 687, 723-24 (3d ed. 2011) (discussing hierarchy of medical evidence, with systematic reviews at the apex).

[3] Schachtman, “The Treatment of Meta-Analysis in the Third Edition of the Reference Manual on Scientific Evidence,” Tortini (Nov. 14, 2011).

[4] John P.A. Ioannidis & Joseph Lau, Systematic Review of Medical Evidence, 12 J.L. & Pol’y 509 (2004).

[5] Lisa Bero, “Evaluating Systematic Reviews and Meta-Analyses,” 14 J. L. & Policy 569, 576 (2006).

[6] See Schachtman, “Cherry Picking; Systematic Reviews; Weight of the Evidence,” Tortini (April 5, 2015); “The Fallacy of Cherry Picking As Seen in American Courtrooms,” Tortini (May 3, 2014); “The Cherry-Picking Fallacy in Synthesizing Evidence,” Tortini (June 15, 2012).

[7] In re Paraquat Prods. Liab. Litig., 730 F. Supp. 3d 793 (S.D. Ill. 2024); see also Schachtman, “Paraquat Shape-Shifting Expert Witness Quashed,” Tortini (Apr. 24, 2024).

[8] See Schachtman, “Unlearning the Learned Treatise Exception,” Tortini (Aug. 21, 2010).

[9] Iain Chalmers, Larry V. Hedges, Harris Cooper, “A Brief History of Research Synthesis,” 25 Evaluation & the Health Professions 12 (2002); Mark Starr, Iain Chalmers, Mike Clarke, Andrew D. Oxman, “The origins, evolution, and future of The Cochrane Database of Systematic Reviews,” 25 Int J. Technol. Assess. Health Care s182 (2009); Mike Clarke, “History of evidence synthesis to assess treatment effects: personal reflections on something that is very much alive,” 109 J. Roy. Soc. Med. 154 (2016). See also Wen-Lin Lee, R. Barker Bausell & Brian M. Berman, “The growth of health-related meta-analyses published from 1980 to 2000,” 24 Eval. Health Prof. 327 (2001).

[10] Alessandro Liberati, Douglas G. Altman, Jennifer Tetzlaff, Cynthia Mulrow, Peter C. Gøtzsche, John P.A. Ioannidis, Mike Clarke, Devereaux, Jos Kleijnen, and David Moher, “The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration,” 151 Ann Intern Med. W-65 (2009); “The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration,” 6 PLoS Med. e1000100 (2009).

[11] Alison Booth, Mike Clarke, Gordon Dooley, Davina Ghersi, David Moher, Mark Petticrew & Lesley Stewart, “The nuts and bolts of PROSPERO: an international prospective register of systematic reviews,” 1 Systematic Reviews 1 (2012); Alison Booth, Mike Clarke, Davina Ghersi, David Moher, Mark Petticrew, Lesley Stewart, “An international registry of systematic review protocols,” 377 Lancet 108 (2011).

[12] Matthew J. Page, Larissa Shamseer, and Andrea C. Tricco, “Registration of systematic reviews in PROSPERO: 30,000 records and counting,” 7 Systematic Reviews 32 (2018).

[13][13] John P. Ioannidis, “The Mass Production of Redundant, Misleading, and Conflicted Systematic Reviews and Meta-analyses,” 94 Milbank Q. 485 (2016).

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The FDA Expert Panel on Talc – More Malarky

June 18th, 2025

On May 20, 2025, as announced, FDA Commissioner Martin Makary held his panel discussion on talc in food and medications.[1] The discussion lasted just under two hours, and is available on YouTube for your viewing and perhaps your amusement. Makary opened and closed the event with what could have been the plaintiffs’ opening and closing statements from one of the many talc trials that have clouded courtrooms across the land. He asked rhetorically: “Why don’t we talk about at our oncology meetings the 1993 National Toxicology Program results that found clear evidence of carcinogenic activity of talc in animal studies?’” Perhaps because the talc findings were questionable at best, and the asbestos findings with respect to gastrointestinal cancers were exculpatory for talc.

Makary’s introductory remarks were followed by the panelists’ introducing themselves by their training and involvement with talc issues. Other than Makary, the participants were FDA Deputy Commissioner Sara Brenner, George Tidmarsh, John Joseph Godleski, Sandra McDonald, Daniel Cramer, Joellen Schildkraut, Malcolm Sim, Steven Pfeiffer, Nicolas Wentzensen, and Nicole C. Kleinstreuer. Godleski and Cramer have served as plaintiffs’ expert witnesses in ovarian cancer litigation, which was not particularly germane to the panel discussion. In their initial discussions of qualifications and background, neither Godleski nor Cramer disclosed his potential conflicts of interest, or the amount of fees earned. Sandra McDonald described her experience in assisting Godleski, but she did not declare whether she earned any money for consulting services to the lawsuit industry. Later in the panel discussion, when George Tidmarsh stated that no one should be vilified for past practices in using talc, Daniel Cramer jumped in to vilify Johnson & Johnson with the suggestion that somehow that company had surreptitiously arranged for the National Cancer Institute to remove a statement about how talc “may be associated with talc use” from its website just before he was about to testify in his first talc trial for plaintiffs.

None of the panelists had served as a defense expert witness. Steven Pfeiffer works for a pharmaceutical company, but not one that had any experience with the safety or efficacy of talc as an ingredient in medications.

None of the panelists had participated in any toxicologic or epidemiologic study of talc on cancers or diseases of the digestive organs. None of the panelists made it his or her business to become familiar with the extensive studies of the asbestos and talc on gastrointestinal cancers. The lack of experience, or specific citations to any study, did not stop Daniel Cramer from suggesting that talc was responsible for inflammatory bowel disease, autoimmune diseases, and gastrointestinal cancers. Like Cramer, epidemiologist Joellen Schildkraut, focused on ovarian cancer, and made the false assertion that the relationship between talc and gastrointestinal cancers is understudied. Schildkraut held back from asserting that talc causes ovarian cancer, but she heartily endorsed banning talc on the precautionary principle. All the panelists concurred with the suggestion that talc be eliminated from food and drugs, without waiting for “the epidemiologists to catch up.”

Two issues were grossly misrepresented by the panelists. None of them, however, was well informed enough for the misrepresentations to have been overt lies. The first whopper was that National Toxicology Program (NTP) testing had shown carcinogenicity of talc in its inhalational studies for the lung and other organs. The second whopper was that rice on talc was used prevalently in the United States, and that it was responsible for digestive organ cancers. Nicole C. Kleinstreuer, who has worked at the NTP, and accurately described its activities gave a description of its animal talc studies, perhaps a bit slanted, but not too inaccurate. When George Tidmarsh later misrepresented NTP talc findings, however, Kleinsteuer was silent.

NTP Ingestion Studies

Makary did not identify the NTP studies to which he referred, but Kleinsteuer described a talc inhalation study that has only one referent. The NTP conducted long-term rodent inhalation and ingestion assays for both talc and different kinds of asbestos, in the 1980s and 1990s. For talc, the NTP published, in 1993, only one long-term inhalational study in rats and mice.[2] In mice, exposed to talc by inhalation for up to two years, there was no evidence of any “neoplastic” effects. The results in rats were more difficult to interpret. In male rats, exposed for over two years, there was weak evidence of neoplastic effects based upon an increased incidence of benign or malignant adrenal gland pheochromocytomas. In female rats, the NTP reported “clear evidence” of excess alveolar/bronchiolar (lung) adenomas and carcinomas and benign or malignant adrenal gland pheochromocytomas of the adrenal gland. The meaning of these rodent studies obviously varies depending upon whether you are a rat or a mouse of a certain breed; the meaning for humans is even murkier, even for humans that are rodent-like. The multiple comparisons across exposure levels for dozens if not hundreds of outcomes, and the lumping of benign and malignant effects together, certainly makes the NTP statistical analyses suspect. This report was marked by significant controversy, and some scientists refused to endorse its finding because adrenal gland pheochromocytomas were not treatment-related; the maximum-tolerated dose was exceeded for female rats at the higher exposure level, thus violating the study’s protocol; and talc is thus not expected to cause tumors in rats (and mice) exposed at levels that do not cause “marked chronic lung toxicity.”[3]

One of the lawsuit industry’s, and Makary’s, theories about the harmfulness of ingested talc is based upon the supposition that talc has asbestos contaminants. This theory is as vague as is the term asbestos, which has no mineralogical meaning; instead, the term asbestos was historically used to refer to six different minerals: actinolite, anthophyllite, amosite (cummingtonite-grunerite), chrysotile, crocidolite, and tremolite. All of these minerals, except for chrysotile, are amphibole minerals. Some of the amphibole minerals occur in both fibrous and non-fibrous form, and the ill health effects of the amphibole fibers are generally attributed to their resistance to biological degradation and their high aspect ratio. Things get a bit crazy because the federal government, for purposes of standardizing aerosol measurements, set the aspect ratio for counting “fibers,” at 3:1. The pathogenicity of “federal fibers,” which are not really fibers, is highly disputed.

The NTP never conducted long-term talc ingestion studies; it did something much better. The NTP tested dietary high-dose, long-term ingestion of various asbestos types in multiple species. The NTP did not leave the exposure issue vague with “asbestos” as the dietary source. Instead, the NTP was more precise when testing whether ingesting “asbestos” was harmful to rodents. The NTP ran separate ingestion experiments on chrysotile, amosite, and crocidolite, with the different form of asbestos making up one percent of the animals’ lifetime diet. Overall, these experiments were “null”; that is, they provided no support for the carcinogenicity of ingested asbestos of the types tested.

The NTP conducted lifetime ingestion studies in male and female rats with a diet of one percent crocidolite asbestos, the most toxic and carcinogenic form of asbestos in human beings. The NTP experiments showed that under these conditions, long-term ingestion of crocidolite asbestos was neither overtly toxic nor carcinogenic in male or in female rats.[4] After crocidolite, amosite asbestos, fibrous cummingtonite-grunerite, named for “asbestos mines of South Africa, is the most toxic and carcinogenic of the asbestos fibers. The NTP showed that feeding male and female rats amosite asbestos for one percent of their diet, for their lifetimes, was not overtly toxic, did not affect their survival, and was not carcinogenic.[5] The NTP repeated its life-time one percent amosite diet in Syrian Golden hamsters, again without toxic or carcinogenic response in either the male or female hamsters.[6]

Looking at the least toxic and carcinogenic asbestos mineral, chrysotile, the NTP’s conducted long-term one percent feed studies of both “short range” and “long range” (chrysotile fiber length) in Syrian Golden hamsters. Again the results were “null”; that is, there was no treatment-related toxicity or carcinogenicity.[7] There were no increases in adrenal cortical adenomas (benign growths) when compared with concurrent controls, but there was an increase of these benign tumors when compared with pooled control groups from other experiments. Ultimately, the NTP concluded that the biological importance of these benign adrenal growths in the absence of cancers or tumors of the gastrointestinal tract (which was the target organ) was questionable, at best.

Because of prior research suggesting that carcinogencity was a function of fiber rigidity and length, the NTP tested ingested chrysotile in rats, at two different fiber lengths. For its experiments, the NTP defined “short-range chrysotile (SR)” as short fibers with a median length of 0.66 microns, and a range of 0.088 to 51.1 microns. “Intermediate-range (IR) chrysotile fibers had a median length of 0.82 microns, with a range from 0.104 to 783.4 microns. The NTP did not use long-range chrysotile fibers, which are generally greater than 5 microns in length. Male and female F344/N rats ingested an NTP one percent diet of chrysotile, in the two lengths of chrysotile, SR and IR, for a lifetime. There were no neoplastic or non-neoplastic diseases, overt toxicity, or decrease in survival associated with SR chrysotile ingestion, in either the male or the female rats.[8] In the female rats, there was no effect on fertility or litter, overt toxicity, or carcinogenicity from IR chrysotile ingestion. The male rats also did not show any adverse clinical signs, but they experienced a statistically insignificant increase in benign colonic polyps, which the NTP stretched to characterize as “some” (but not clear) evidence of carcinogenicity.

Rice is Nice, With or Without Talc

The FDA panelists’ inaccurate claims about talc on rice also cry out for rebuttal, which no panelist seemed able or willing to give. Given that the panel was convened with only four days notice, and without public comment, it operated in a fact-free zone, and operated mostly as a propaganda exercise. The history of the ingested asbestos and talc controversy goes back over half a century. Some background is needed to understand exactly how outlandish the rice-on-talc claim is.

The causal association between asbestosis and lung cancer was well established by the early 1960s,[9] as was the causal association between crocidolite asbestos exposure and mesothelioma.[10] Some sources carelessly credit Irving Selikoff with these discoveries, but he was not so much of a discoverer, as he was a zealous spokesman for the safety of asbestos-exposed workers. Selikoff worked hand-in-hand with various labor unions to publicize and politicize asbestos risks that had been shown by other workers. Credit for the lung cancer connection properly goes to earlier work done by Sir Richard Doll and others, and the crocidolite-mesothelioma connection was shown by J. Christopher Wagner, in 1960. Where Selikoff deserves credit is in tireless efforts to expand the scope of asbestos-related diseases beyond lung cancer and mesothelioma, with or without sufficient evidence, and thus to expand the compensability of other diseases of ordinary life in asbestos workers.

In his efforts to extend the scope of compensation, Selikoff did not limit himself to risks that had been scientifically established; he sought to expand the list of asbestos-related diseases. He advanced the unsubstantiated notions that all six kinds of asbestos minerals carried the same risks, that asbestos caused virtually every kind of cancer in humans, that any asbestos in the environment required extreme remedial action, and that asbestos was responsible for a very high percentage of all human cancers.

No doubt Selikoff wanted credit for scientific discoveries, but he also wanted science that would support compensation. Selikoff understood that if the asbestos workers stopped smoking, their risks of lung cancer would fall, and their cancer morbidity and mortality would be more influenced by gastrointestinal cancers, given that colorectal cancer was the leading cause of cancer-related death in non-smoking men, in the 1960s.

By 1950, Selikoff had already become an advocate, who testified and wrote reports as a claimants’ expert witness in many asbestos cases. In the early 1950s, New Jersey lawyer Carl Gelman retained Selikoff to examine 17 workers from the Paterson plant of Union Asbestos and Rubber Company (UNARCO). Gelman filed workers’ compensation claims on behalf of these UNARCO workers, and Selikoff supported Gelman’s claims with reports and testimony. In the early 1950s, Anton Szczesniak, one of the UNARCO claimants, with Selikoff’s support as an expert witness, sought compensation for “intestinal cancer.” In 1965, Selikoff testified to support an asbestos insulator’s claim that asbestos exposure caused his colorectal cancer.[11] In 1974, Selikoff wrote a review article on asbestos exposure and gastrointestinal cancers, without any disclosure of his pro-plaintiff testimonial adventures.[12] Serious epidemiologists such as Sir Richard Doll and Sir Richard Peto pushed back on Selikoff’s exaggerated projections of asbestos-related mortality,[13] and his assertion that asbestos caused digestive system cancers.[14] Forty years after Selikoff testified for the claimant in an asbestos colorectal cancer case, the Institute of Medicine published a systematic review of the evidence available to Selikoff and later evidence, which showed that the evidence was insufficient “to infer a causal relationship between asbestos exposure and pharyngeal, stomach, and colorectal cancers.”[15]

Selikoff’s rent-seeking and fear-mongering spawned many asbestos scares. Some scientists accepted Selikoff’s dogma that a single asbestos fiber, of any variety, could cause any human cancer. The Mt. Sinai jihad against “asbestos” extended to any exposures involving asbestos, or even other minerals that contained “elongated mineral particles,” that nominally met the crude definition of asbestos. This jihad led to a prolonged litigation against the Reserve Mining Company, which had permits to dump taconite tailings in Lake Superior, since the late 1940s. Using Selikoff’s claim that “asbestiform” mineral particles had entered the water supply, the U.S. Environmental Protection Agency was able to obtain an injunction against the mining company.[16]

Regulatory overreach, Selikoff’s exaggerated testimony, and the trial judge’s partiality and bias marred the litigation.[17] After decades of research on asbestos in drinking water, there remains no substantial evidence that supports a conclusion that ingested asbestos in drinking water causes gastrointestinal or any other cancer.[18]

Selikoff was the head of an anti-asbestos lobby that promoted the fiction that asbestos was responsible for all manners of human ailments, regardless of dose or route of administration.[19] One of the panics he helped initiate involved the claim that talc-dusted rice was responsible for the high rate of stomach cancer among Japanese in Japan.

Reuben Merliss published an article in Science, in 1971, in which he attempted to attribute the high rate of stomach cancer in Japan to the Japanese custom of dusting rice with talc. Merliss relied upon overall population rates and trends to draw an ecologic inference that the Japanese rice (with talc and any asbestos contaminants) was responsible for the Japanese higher incidence of stomach cancer.[20]

The Merliss hypothesis, inspired by Selikoff, was sunk by a much more careful analysis (which got less media coverage). Two epidemiologists analyzed data about use of talc-coated rice in Japan and Hawaii, and found no support for the claim that talc-coated rice increased the risk of developing stomach cancer.[21]

Their more careful dietary assessment found high rates of stomach cancer among Japanese in Japan who did not consume talc-coated rice, while Japanese in Hawaii, who consumed considerable quantities of talc-coated rice had intermediate rates of stomach cancer (lower than in Japan). Filipinos in Hawai had very low rates of gastric cancer, even though they consumed the greatest amounts of talc-coated rice of any of the observed groups. The secular incidence trend of stomach cancer decreased more substantially among the talc-exposed Japanese living in Hawaii than among the non-exposed Japanese living in Japan.

Although the asbestos perpetual motion litigation machine continues to churn, the lawsuit industry has been hampered by the bankruptcy of virtually every company that made an asbestos-containing product, and the reduction of asbestos use and exposures over the last 50 years. The lawsuit industry’s shift to demonize and monetize talc as the next mineral target was predictable. What was not predictable was that we would have a Secretary of Health & Human Services whose sole experience in medicine has been in suing pharmaceutical and other manufacturing industries, perpetuating medieval beliefs in the miasma theory of disease causation,[22] and spreading conspiracies, misinformation, and disinformation. FDA Commissioner Makary has shown himself to be a willing accomplice in advancing the Secretary’s agenda. In his closing remarks, Makary made unsupported assertions, then retreated to the dodge that he was just asking questions. Makary strongly suggested that the recent increase in colorectal cancer among young people has been caused by the use of talc in food and medications. He failed to reference any evidence for his suggestion, which is, in any event, hard to square with the history of use of talc in medications for centuries, and the steady overall decline in the incidence of colorectal cancer in men and women.[23]

The Center for Truth in Science has sponsored rigorous systematic reviews of the evidence on cosmetic talc use and female reproductive cancers,[24] and respiratory cancers.[25] The systematic review of talc on reproductive organ cancers integrated evidence across toxicologic and epidemiologic studies, and found suggestive evidence of no association between the use of perineal talc and ovarian and endometrial cancers. The systematic review of talc use and respiratory cancers similarly integrated the available toxicologic and epistemiologic evidence, and rejected a causal association. The review reached a conclusion of suggestive evidence in the opposite direction – of no association between inhaled talc and mesothelioma or lung cancer.

The FDA talc panel was fool’s gold, and not the promised “gold standard” science. Rather than engaging with the systematic reviews sponsored by the Center, or for that matter with any systematic reviews, Commissioner Makary and his panel wallowed in anecdotes, stories, and isolated study results, without trying to identify and synthesize all the available evidence.

[1] FDA Expert Panel on Talc, “Independent Expert Panel to Evaluate Safety and Necessity of Talc in Food, Drug, and Cosmetic Products,” FDA (May 20, 2025).

[2] NTP Technical Report on the Toxicology and Carcinogenesis Studies of Talc (CAS No. 14807-96-6) in F344/N Rats and B6C3F Mice (Sept. 1993).

[3] Jay I. Goodman, “An Analysis of the National Toxicology Program’s (NTP) Technical Report (NTP TR 421) on the Toxicology and Carcinogenesis Studies of Talc,” 21 Regulatory Toxicol. & Pharmacology 244 (1995). See also Robyn L. Prueitt, Nicholas L. Drury, Ross A. Shore, Denali N. Boon & Julie E. Goodman, “Talc and human cancer: a systematic review of the experimental animal and mechanistic evidence,” 54 Critical Reviews in Toxicology 359 (2024).

[4] NTP TR-280 Toxicology and Carcinogenesis Studies of Crocidolite Asbestos (CASRN 12001-28-4) In F344/N Rats (Feed Studies) (1988).

[5] NTP TR-279 Toxicology and Carcinogenesis Studies of Amosite Asbestos (CASRN 12172-73-5) in F344/N Rats (Feed Studies) (1990).

[6] NTP TR-249 Lifetime Carcinogenesis Studies of Amosite Asbestos (CASRN 12172-73-5) in Syrian Golden Hamsters (Feed Studies) (1983).

[7] NTP TR-246 Lifetime Carcinogenesis Studies of Chrysotile Asbestos (CASRN 12001-29-5) in Syrian Golden Hamsters (Feed Studies) (1990).

[8] NTP – TR-295 Toxicology and Carcinogenesis Studies of Chrysotile Asbestos (CASRN 12001-29-5) in F344/N Rats (Feed Studies) (1985).

[9] See Richard Doll, “Mortality from Lung Cancer in Asbestos Workers,” 12 Br. J. Indus. Med. 81 (1955).

[10] See J. Christopher Wagner, C.A. Sleggs, and Paul Marchand, “Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province,” 17 Br. J. Indus. Med. 260 (1960); J. Christopher Wagner, “The discovery of the association between blue asbestos and mesotheliomas and the aftermath,” 48 Br. J. Indus. Med. 399 (1991).

[11] See “Health Hazard Progress Notes,”16 The Asbestos Worker 13 (May 1966) (“A recent decision has widened the range of compensable diseases for insulation workers even further. A member of Local No. 12. Unfortunately died of a cancer of the colon. Dr. Selikoff reported to the compensation court that his research showed that these cancers of the intestine were at least three times as common among the insulation workers as in men of the same age in the general population. Based upon Dr. Selikoff’s testimony, the Referee gave the family a compensation award, holding that the exposure to many dusts during employment was responsible for the cancer. The insurance company appealed this decision. A special panel of the Workman’s Compensation Board reviewed the matter and agreed with the Referee’s judgment and affirmed the compensation award. This was the first case in which a cancer of the colon was established as compensable and it is likely that this case will become an historical precedent.”).

[12] Irving J. Selikoff, “Epidemiology of Gastrointestinal Cancer,” 9 Envt’l Health Persp. 299 (1974).

[13] Richard Doll & Richard Peto, “The causes of cancer: quantitative estimates of avoidable risks of cancer in the United States today,” 66 J. Nat’l Cancer Instit. 1191 (1981).

[14] Richard Doll and Julian Peto, Asbestos: Effects on Health of Exposure to Asbestos 8 (1985).

[15] Jonathan M. Samet, et al., Asbestos: Selected Cancers – Institute of Medicine (2006).

[16] See Wendy Wriston Adamson, Saving Lake Superior: A Story of environmental action (1974); Frank D. Schaumburg, Judgment Reserved: A Landmark Environmental Case (1976); Robert V. Bartlett, The Reserve Mining Controversy: Science, Technology, and Environmental Quality (1980); Thomas F. Bastow, This Vast Pollution: United States of America v. Reserve Mining Company (1986); Michael E. Berndt & William C. Brice, “The origins of public concern with taconite and human health: Reserve Mining and the asbestos case,” 52 Regulatory Toxicol. & Pharmacol. S31 (2008).

[17] Reserve Mining Co. v. Lord, 529 F.2d 181 (8th Cir. 1976) (removing Judge Lord from case).

[18] See World Health Organization, Asbestos in Drinking Water (4th ed. 2021) (“no causal association between asbestos exposure via drinking-water and cancer development has been reported for any asbestos fibre type”); Jennifer Go, Nawal Farhat, Karen Leingartner, Elvin Iscan Insel, Franco Momoli, Richard Carrier & Daniel Krewski, “Review of epidemiological and toxicological studies on health effects from ingestion of asbestos in drinking water,” 54 Critical Reviews in Toxicology 856 (2024) (“Based on high-quality animal studies, an increased risk for cancer or non-cancer endpoints was not supported, aligning with findings from human studies. Overall, the currently available body of evidence is insufficient to establish a clear link between asbestos contamination in drinking water and adverse health effects.”); Kenneth D. MacRae, “Asbestos in drinking water and cancer,” 22 J. Royal Coll. Physicians 7 (1988).

[19] Francis Douglas Kelly Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997) (“[A]n anti-asbestos lobby, based in the Mount Sinai School of Medicine of the City University of New York, promoted the fiction that asbestos was an all-pervading menace, and trumped up a number of asbestos myths for widespread dissemination, through media eager for bad news.”).

[20] Rueben R. Merliss, “Talc-Treated Rice and Japanese Stomach Cancer,” 173 Science 1141 (1971). The claim persists in the underworld of medical speculation. See E. Whitin Kiritani, “Asbestos and Stomach Cancer in Japan – A Connection?” 33 Medical Hypotheses 159 (1990).

[21] Grant N. Stemmermann & Lawrence N. Kolonel, “Talc-coated rice as a risk factor for stomach cancer,” 31 Am. J. Clin. Nutrition 2017 (1978).

[22] Paul Offit, “Understanding RFK Jr.,” Beyond the Noise (Feb. 11, 2025).

[23] American Cancer Society, “Key Statistics for Colorectal Cancer” (last revised April 28, 2025).

[24] Heather N. Lynch, Daniel J. Lauer, Olivia Messina Leleck, Rachel D. Freid, Justin Collins, Kathleen Chen, William J. Thompson, A. Michael Ierardi, Ania Urban, Paolo Boffetta & Kenneth A. Mundt, “Systematic review of the association between talc and female reproductive tract cancers,” 5 Front. Toxicol. 1157761 (2023).

[25] Heather N. Lynch, Daniel J. Lauer, William J. Thompson, Olivia Leleck, Rachel D. Freid, Justin Collins, Kathleen Chen, A. Michael Ierardi, Ania M. Urban, Michael A. Cappello, Paolo Boffetta & Kenneth A. Mundt, “Systematic review of the scientific evidence of the pulmonary carcinogenicity of talc,” 10 Front. Public Health 989111 (2022).

Posted in Asbestos, Causation, Conflicts of Interest, Evidence, Expert Witnesses, Regulation, Toxicological Evidence | No Comments »

FDA Malarky on Ingested Talc

June 6th, 2025

A couple of weeks ago, the Wall Street Journal ran an editorial that complained that FDA Commissioner Makary had touted dodgy evidence about the potential harms of talcum powder in food and medications,[1] and called an improper public meeting to discuss his concerns. The editorial noted the procedural irregularity of convening a meeting to review evidence of the supposed harms of talc in food and drugs, without proper notice and public comment.[2] The panel met just four days after the FDA’s press release.[3]

The FDA’s announcement of the irregular meeting cited last year’s IARC classification of talc in its group 2A, “probably carcinogenic” to humans, and an article in a new journal, the Journal of the Academy of Public Health, on the editorial board of which, Martin Makary sits.

The irregularity of this FDA meeting becomes even more obvious upon closer inspection. Much could be said about the irregularity of IARC classifications. The IARC defines “probably” in its 2A “probably carcinogenic” classification in a distinctly unscientific way when it reveals, in its Preamble, that its use of probably has no quantitative meaning. In attaching a 2A label to talc, the IARC rejected a conclusion that there was sufficient evidence of human carcinogenicity for talc; indeed, it found the human epidemiology on point to be “limited,” in other words, insufficient. Furthermore, the IARC’s limited conclusion was based upon a claimed association between perineal talc exposure and ovarian cancer.[4]

The irregularities abound. The FDA announced that it was convening an “independent panel of scientific experts” to explore the issue of talc in food and in drugs. And yet, one of the panelists, Daniel Cramer, has served as an expert witness for the talc lawsuit industry on multiple occasions, against Johnson & Johnson.[5] How irregular that no defense expert witness was invited to participate in the panel.

The irregularity of Daniel Cramer’s participation may be Trumped by the irregularity of the entire enterprise. Commissioner Makary works for Secretary Robert F. Kennedy, Jr., who has spent much of his adult life advancing litigations for the lawsuit industry. Kennedy’s son, Conor, is a lawyer at Wisner Baum, a lawsuit industry firm that has cases against Johnson & Johnson. The day of the FDA meeting, but before the panel convened, Commissioner Makary barged into another Advisory Committee meeting, convened to discuss the licensing of an unrelated anti-cancer therapeutic, and ranted about how talc was causing cancer.

Earlier this week, Commissioner Makary replied to the Wall Street Journal editorial, but failed to make his case on the science.[6] He cited IARC, but failed to disclose the meaning of the IARC classification, and to what it applied. Makary cited a 2019 Taiwanese study (Chang) that he described as having reported an association between the oral intake of talc and gastrointestinal cancer.[7] What was most irregular for a scientist who has responsibility for the FDA, however, was Makary’s failure to describe the Chang study accurately.

Chang set out to study stomach cancer, not all of gastrointestinal cancers, by looking at stomach cancer incidence in users a talc, used as a Chinese herbal, in high, medium, and low levels. The study was a typical insurance claims database study, which is interesting but which can yield only limited information. Chang and colleagues had no information about lifestyle variables such as smoking, diet, or obesity. The authors note that in Taiwan, talc is used as an antipyretic and diuretic agent, but they fail to discuss why study participants would have used an herbal remedy with such an indication for any significant length of time. To their credit, the authors excluded patients with peptic ulcer disease or Helicobacter pylori infection prior to the inclusion date. Gastritis and infection with h. pylori are potent causes of stomach cancer. Unfortunately, the information on participants’ infection status, for exclusion, was made before 1997, and so the authors had no information whether the participants who had stomach cancer actually had h. pylori infections at or near the time that they were diagnosed with stomach cancer. Helicobacter pylori infections have an attributable risk for stomach cancer of about 75%.[8] Similarly, the authors lacked information on other risk factors, such as high salt intake, pernicious anemia, EBV infection, alcohol, family predisposition, and socioeconomic status.

Using the low-exposure group as their control, the Chang study reported an adjusted stomach cancer hazard ratio of 1.58 (95% CI, 0.79 – 3.17; p = 0.19), for participants with high exposure, and an adjusted hazard ratio of 2.30 (95% CI, 1.48 – 3.57; p < 0.001) among persons with medium exposure. The authors claimed these data showed an association, but they acknowledged that the lack of a dose-response relationship made the association less likely to be causal. The association, such as it was, however, came unraveled after they excluded participants whose herbal talc use was less than five years. The exclusion, which is biologically important given that latency and induction periods for carcinogenesis are likely longer than five years, vitiated the statistically significant correlation between talc ingestion and the incidence of stomach cancer. The authors’ conclusion was thus pretty tame: “[d]espite the absence of dose-response effect, there might be a link between stomach cancer and talc.” And then again, there might not be.

Makary was not content to argue from weak and equivocal evidence. He offered a sop to the lawsuit industry and his boss, Robert F. Kennedy, Jr., by asking rhetorically whether the plaintiffs’ bar might be correct on talc. According to Makary, “They [lawsuit industry firm] were [correct] with OxyContin, Vioxx and Makena. Perhaps they will be with talc.” Well, even the blind squirrel sometimes finds a nut. OxyContin litigation turned on a marketing issue, and Makena (hydroxyprogesterone caproate), a progestin injection was withdrawn because of lack of efficacy. Even Vioxx, which had an unlabeled potential harm for a limited subgroup of users, spawn a litigation in which the lawsuit industry tried to make every user, even those who may have licked a pill for one day, a winner in the lawsuit lottery.

[1] Editorial Board, “The FDA Takes a Trial-Lawyer Turn,” Wall St. J. (May 21, 2025).

[2] FDA News Release, “FDA to Host Inaugural, Independent, Scientific Expert Panel Open to Public,” FDA (May 16, 2025).

[3] FDA Expert Panel on Talc, “Independent Expert Panel to Evaluate Safety and Necessity of Talc in Food, Drug, and Cosmetic Products,” FDA (May 20, 2025). The participants were FDA Commissioner Martin A. Makary, FDA Deputy Commissioner Sara Brenner, and a group of scientists, George Tidmarsh, John Joseph Godleski, Sandra McDonald, Daniel Cramer, Joellen Schildkraut, Malcolm Sim, Steven Pfeiffer, Nicolas Wentzensen, and Nicole C. Kleinstreuer.

[4] IARC Press Release no. 352, “IARC Monographs evaluate the carcinogenicity of talc and acrylonitrile” (July 5, 2024).

[5] See Berg v. Johnson & Johnson Consumer Co., 983 F.Supp.2d 1151, 1154 (D.S.D. 2013); Carl v. Johnson & Johnson, 464 N.J. Super. 446, 237 A.3d 308, 310 (N.J. App. Div. 2020).

[6] Makary, “The FDA Presents Its Case for Targeting Talc,” Wall St. J. (June 2, 2025).

[7] Che-Jui Chang, Yao-Hsu Yang, Pau-Chung Chen, Hsin-Yi Peng, Yi-Chia, Sheng-Rong Song & Hsiao-Yu Yang, “Stomach Cancer and Exposure to Talc Powder without Asbestos via Chinese Herbal Medicine: A Population-Based Cohort Study,” 16 Internat’l J. Envt’l Res. Public Health 717 (2019).

[8] Raghav Sundar, Izuma Nakayama, Sheraz R Markar, Kohei Shitara, Hanneke W M van Laarhoven, Yelena Y. Janjigian & Elizabeth C. Smyth, “Gastric cancer,” 405 Lancet 2087, 2089 (2025).

Posted in Asbestos, Regulation, Scientific Evidence, Talc | No Comments »

The Relative Implausibility of Relative Plausibility

May 26th, 2025

For the moment, in the American legal academy, there seems to be a fair amount of support for the idea that the burden of proof in fact-finding is centered around a vigorous contest between the plausibility of competing stories advanced by the litigants. Professors Ronald Allen and Alex Stein, two well-respected evidence law scholars have written widely about this “relative plausibility” theory of adjudication and the burden of proof.[1] They claim to “demonstrate that factfinders decide cases predominantly by applying the relative plausibility criterion guided by inference to the best explanation … .”[2] As they see American courtroom practice, the norm is “the relative plausibility mode of factfinding involving a rigorous comparison between the parties’ stories about the individual event.”[3] They insist that their “theory aligns with ordinary people’s natural reasoning.”[4]

I am not so sure. Semantically, the authors’ choice of the term “plausibility” is curious. Plausibility in ordinary usage has only a tenuous relationship with epistemic warrant. Allen and Stein acknowledge that in law (as in science and in life), the “coin of the realm is truth.” Plausibility in epistemology and philosophy of science, however, is typically treated as a weak and often irrelevant factor in assessing the correctness of a factual (scientific) claim. A leading textbook of epidemiology, for instance, offers that

“[a] causal explanation is plausible if it appears reasonable or realistic within the context in which the hypothesized cause and its effect occur. *** Plausibility can change as the context evolves and will be misleading when current understanding is misleading or wrong.”[5]

A plausible fact is not the same as a known fact, or a well-established fact. In his oft-cited after-dinner speech, Sir Austin Bradford Hill, for instance, acknowledged that plausibility is a helpful but non-necessary consideration in evaluating an association for causality, but he cautions that plausibility

“is a feature I am convinced we cannot demand. What is biologically plausible depends on the biological knowledge of the day.”

Since Hill, many scientific writers have relegated plausibility to a limited role in assessing the correctness of a causal claim. In the language of a recent effort to modernize Hill’s factors, one author noted that “plausibility and analogy do not work well in most fields of investigation, and their invocation has been mostly detrimental.”[6]

To be sure, Allen and Stein do, in some places, make clear that they take plausibility to mean more than some uninformed Bayesian prior. Relative plausibility in their view thus has some connection to the coin of the realm. At least, fact finders are seen as considering more than the usual extent of plausibility; they must “determine which of the parties’ conflicting stories makes most sense in terms of coherence, consilience, causality, and evidential coverage.”[7]

Relativity of Plausibility

If we are truly concerned with “naturalism” (ordinary reasoning?) then we should give some weight to how people react to a claim that has support. In the real world, real people are implicitly aware of Brandolini’s Law. Inspired by his reading of Daniel Kahneman’s Thinking, Fast and Slow,[8] Alberto Brandolini articulated the “Bullshit Asymmetry Principle,” in a 2013 peer-reviewed tweet. According to Brandolini, The work needed to refute bullshit is [at least] an order of magnitude greater than the work needed to produce it.

Despite its crude name, the Bullshit Asymmetry Principle has a respected intellectual provenance. In 1845, economist Frédéric Bastiat expressed an early notion of the adage:

“We must confess that our adversaries have a marked advantage over us in the discussion. In very few words they can announce a half-truth; and in order to demonstrate that it is incomplete, we are obliged to have recourse to long and dry dissertations.”[9]

Recognition of Bullshit Asymmetry actually goes back to ancient times. The Roman lawyer and teacher of rhetoric, Marcus Fabius Quintilianus, known as Quintilian to his friends, addressed the principle in his Institutio Oratoria:

“The task of the accuser is consequently straightforward and, if I may use the phrase, vociferous; but the defence requires a thousand arts and stratagems.”[10]

Quintilian’s insight explains why most people, without invoking economic efficiency or grand moral theories, believe it is natural to place the burden of proof upon the accuser or the pursuer, as opposed to the defender.

The demands made upon us by claims and “stories,” often frivolous, result in our naturally evaluating the warrant (or plausibility if you insist) for a claim before we become mired down in assessing “relative plausibility.” Courts have developed procedural mechanisms, such as summary adjudication and expert witness gatekeeping, to avoid unnecessary detailed assessments of relative plausibility. Even when cases are submitted to the factfinder, the decision may be made solely on “plausibility” of the story proffered by the party with the burden of proof.

The framing of adjudication and the burden of proof as relative plausibility seems to contradict what often happens in American courtrooms. Frequently, the defense does not put forward a “story,” but attempts to show that the plaintiff’s story is rubbish. Indeed, litigation may end without the plausibility of the defense position ever being considered. In the litigation over health claims involving exposure to Agent Orange, Judge Jack Weinstein granted summary judgment because the plaintiffs’ medical causation case was weak and insufficient.[11] The defense may have been even weaker in terms of its “coherence, consilience, causality, and evidential coverage,” but the party with the burden of proof attracts the first round of critical scrutiny in the summary judgment process. In Agent Orange, Judge Weinstein found the plaintiffs’ “proofs” to be rather crummy, without regard for the strength or weakness of the defendants’ evidence.

Similarly, Judge Weinstein granted summary judgment on plaintiffs’ claims of systemic disease injury in the silicone gel breast implant litigation. In granting judgment, Judge Weinstein pretermitted the defendants’ motions to exclude plaintiffs’ expert witnesses on grounds of Rules 702 and 703. Again, without comparison with the defendants’ “story,” Judge Weinstein found the plaintiffs’ story to be insufficient.[12]

The situation in Agent Orange and in Silicone Gel often obtains in trial itself. Defendants are often unable to disprove the plaintiffs’ claim, and the law does not require them to do so. When the evidentiary display is insufficient to support a claim, it may well be insufficient to show the claim is false. Defendants may want to be able to establish their own “story,” but the best they may have to offer is a showing that the plaintiffs’ story is not credible. Allen and Stein suggest that “[t]heoretically, a defendant can simply deny the plaintiff’s complaint, … but this virtually never occurs.”[13] They cite to no empirical evidence in claiming that “a rigorous comparison between the parties’ stories about the individual event is the norm in American courtrooms.”[14]

As shown by the summary judgment examples above, the burden of proof means something quite different from Allen and Stein’s contention about relative plausibility. Before the advent of expert witness gatekeeping, one of the few ways that a party could challenge an adversary’s expert witness was to object that the plaintiff’s medical expert witnesses offered conflicting opinions on a key factual issue in dispute. In Pennsylvania, dismissals for inconsistent expert witness opinion testimony is known as the “Mudano rule,” for a 1927 Pennsylvania Supreme Court case that held that “there must be no absolute contradiction in their essential conclusions.”[15] The Mudano rule arises because the plaintiff must furnish consistent evidence on key issues, even though the jury could otherwise freely choose to accept some or all or none of the inconsistent expert witnesses’ testimony. The Mudano rule requires dismissal without regard to the “plausibility” or implausibility of the defense case.[16]

The Mudano rule follows from the plaintiff’s having the burden of proof. When the party with the burden of proof proffers two conflicting opinions, the guesswork is simply too palpable for an appellate court to tolerate. The rule does not apply to the defense case, should the defense mange to proffer two inconsistent expert witnesses on a key issue raised by plaintiff’s case.[17]

The party without the burden of proof on causation or other key issue requiring expert witness testimony need not present any expert testimony. And if the opposing party does present expert witnesses, the law does not require that they be as precise or certain as those presented by the party with the burden. As one work-a-day appellate court put the matter:

“Absent an affirmative defense or a counterclaim, the defendant’s case is usually nothing more than an attempt to rebut or discredit the plaintiff’s case. Evidence that rebuts or discredits is not necessarily proof. It simply vitiates the effect of opposing evidence. Expert opinion evidence, such as that offered by [the defendant] in this case, certainly affords an effective means of rebutting contrary expert opinion evidence, even if the expert rebuttal would not qualify as proof.”[18]

A defendant need not engage in “story telling” at all; it may present an expert witness to testify that the plaintiff’s causation claim is bogus, even if the alternatives are merely possible. This statement of law with respect to the required certitude of expert witnesses and the burden of proof comes from a Pennsylvania case, but it appears to be the majority rule.[19]

The asymmetry created by the epistemic requirements of the burden of proof undermines the simplistic model of a court, or jury, deciding the “relative plausibility” of a claim.

Jury Instructions

The typical jury instruction on expert witness opinion testimony also shows that the burden of proof may operate without the head-to-head comparison of “stories,” as suggested by Allen and Stein. Under the law of most states, the trier of fact is free to accept some, all, or none of an expert witness opinion. In New Jersey, for instance, jurors are instructed that they

“are not bound by the testimony of an expert. You may give it whatever weight you deem is appropriate. You may accept or reject all or part of an expert’s opinion(s).”[20]

The practice of American courts with respect to burden of proof does not support the reductionist formula offered by the evidence law scholars. Burden of proof has implications in terms of summary judgment and directed verdict practice, which seem glossed over by “relative plausibility.” Furthermore, in situations in which the factfinder assesses both parties’ stories for relative plausibility, it must reject the story from the party with the burden of proof, when that party fails to show its story is more likely than not correct, even when the opponent’s story has a lesser plausibility.

Cases almost always involve incomplete evidence, and so we should expect that evidential warrant, or relative plausibility, or posterior probability of both sides’ cases to be less than complete or 100 percent. If the party with the burden has a story with 40% probability, and then opponent’s story has a 30% probability, the case still results in a non-suit.

[1] Ronald J. Allen & Alex Stein, “Evidence, Probability, and the Burden of Proof,” 55 Ariz. L. Rev. 557 (2013) [cited herein as Allen & Stein]. They are not alone in endorsing relative plausibility, but for now I will key my observations to Allen and Stein’s early paper on relative plausibility.

[2] Id. at 4. Allen and Stein cite the classical proponents of inference to the best explanation, but they do not in this 2013 article describe or defend such inferences in detail. See Peter Lipton, Inference to the Best Explanation (2d ed. 2004); Gilbert H. Harman, “The Inference to the Best Explanation,” 74 Philosophical Rev. 88 (1965).

[3] Allen & Stein at 14.

[4] Allen & Stein at 15.

[5] Tyler J. VenderWeele, Timothy L. Lash & Kenneth J. Rothman, “Causal Inference and Scientific Reasoning,” chap. 2, in Timothy L. Lash, et al., Modern Epidemiology 17, 20 (4^th ed. 2021).

[6] Louis Anthony Cox, Jr., “Modernizing the Bradford Hill criteria for assessing causal relationships in observational data,” 48 Crit. Rev. Toxicol. 682, 684 (2018).

[7] Allen & Stein at 1.

[8] Daniel Kahneman, Thinking, Fast and Slow (2011).

[9] Frédéric Bastiat, Economic Sophisms (1845), in The Bastiat Collection vol. 1, t 172 (2007).

[10] Quintilian, Institutio Oratoria, book V, chapters 13-14 (Butler transl. 1920).

[11] In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 785 (E.D.N.Y. 1984), aff’d 818 F.2d 145, 150-51 (2d Cir. 1987) (approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988); In re “Agent Orange” Prod. Liab. Litig., 611 F. Supp. 1223 (E.D.N.Y. 1985), aff’d, 818 F.2d 187 (2d Cir. 1987), cert. denied, 487 U.S. 1234 (1988). See Peter H. Schuck, Agent Orange on Trial: Mass Toxic Disasters in the Courts (1987).

[12] In re Breast Implant Cases, 942 F. Supp. 958 (E.& S.D.N.Y. 1996).

[13] Allen & Stein at 12.

[14] Allen & Stein at 14.

[15] Mudano v. Philadelphia Rapid Transit Co., 289 Pa. 51, 60, 137 A. 104, 107 (1927).

[16] See Daniel E. Cummins, “The ‘Mudano’ Rule: Conflicting Expert Opinions Often Prove Fatal,” The Legal Intelligencer (Mar. 16, 2017). See also Brannan v. Lankenau Hospital, 490 Pa. 588, 596, 417 A.2d 196 (1980) (“a plaintiff’s case will fail when the testimony of his two expert witnesses is so contradictory that the jury is left with no guidance on the issue”); Menarde v. Philadelphia Transportation Co., 376 Pa. 497, 501, 103 A.2d 681 (1954). See also Halper v. Jewish Family & Children Services of Great of Philadelphia, 600 Pa. 145, 963 A.2d 1282, 1287-88 (2009).

[17] See Kennedy v. Sell, 816 A.2d 1153, 1159 (Pa. Super. 2003).

[18] Neal v. Lu, 365 Pa. Super. 464, 530 A.2d 103, 109-110 (1987); see also Jacobs v. Chatwani, 2007 Pa. Super. 102, 922 A.2d 950, 958-960 (2007) (holding that defense expert witnesses are not required to opinion to reasonable medical certainty). See generally James Beck, “Reasonable Certainty and Defense Experts,” Drug & Device Law (Aug. 4, 2011).

[19] Jordan v. Pinamont, 2007 WL 4440900, at *2 (E.D. Pa. May 8, 2007) (“Defendants are entitled to inform the jury of other medical conditions which reasonably could have caused Plaintiff’s complaints, even if it cannot be stated to a reasonable degree of medical certainty that Defendants’ proffered alternatives were, in fact, the cause”); Johnesee v. The Stop & Shop Co., 174 N.J. Super. 426, 416 A.2d 956, 959 (N.J. Super. App. Div. 1980) (holding that defense expert witness may criticize plaintiff’s expert witness’s opinion as unfounded even though he can offer only possible alternative causes); Holbrook v. Lykes Bros. Steamship Co., 80 F.3d 777, 786 (3d Cir. 1996) (affirming admission of defense expert testimony that plaintiff had failed to exclude radiation as a possible cause of his mesothelioma, but reversing judgment for the defense on other grounds); Wilder v. Eberhart, 977 F.2d 673, 676-77 (1st Cir. 1992) (applying New Hampshire law); Allen v. Brown Clinic, P.L.L.P., 531 F.3d 568, 574-75 (8th Cir. 2008) (applying South Dakota law).

[20] N.J. CHARGE 1.13, citing State v. Spann, 236 N.J. Super. 13, 21 (App Div. 1989). See Pennsylvania’s Suggested Standard Civil Jury Instructions. PA. SSJI (Civ), § 4.100, § 4.80 (2013) (providing that the jury is not required to accept an expert witness’s testimony); Nina Chernoff, Standard jury instruction in New York on expert testimony (2023) (“You may accept or reject such testimony, in whole or in part, just as you may with respect to the testimony of any other witness.”).

Posted in Scientific Evidence, Trial Procedure | No Comments »

SCOTUS Embraces Totalitarian Version of Unitary Executive Doctrine

May 25th, 2025

Earlier this year, President Felonious Trump fired Gwynne Wilcox, a member of the National Labor Relations Board (NLRB), and Cathy A. Harris, the chair of the Federal Merit Systems Protection Board (MSPB). Wilcox sued, and the district court in the District of Columbia enjoined the President from removing her. Federal statutory law prohibits the president from removing the plaintiff officers except for cause. See 29 U. S. C. § 153(a); 5 U. S. C. § 1202(d). Felonious Trump identified no such cause.

Felonious Trump took the case up to the Supreme Court, not on the merits, but on the propriety of the interlocutory stay. Last week, the Court reversed the stay, and remanded the case to be heard on its merits.[1] But in addressing the stay, the Court necessarily addressed the merits, as it was required to do, in assessing the likelihood of success. The net result was that the Court signaled its embrace of an imagined unitary and totalitarian conception of the president’s power.

In an unsigned opinion, the Court went beyond its limited role in addressing the interlocutory injunction, when it declared:

“Because the Constitution vests the executive power in the President, see Art. II, § 1, cl. 1, he may remove without cause executive officers who exercise that power on his behalf.”[2]

This assertion begged the question whether these officers were the sort of executive officers whom the president can remove at will. The Court’s reasoning was unusually anemic. The Court assumed that the two fired officials exercise “considerable executive power,” which thus puts them at the mercy of the president. Of course, the whole point of independent agencies is that they exercise hybrid executive-legislative-judicial power. The Court briefly acknowledged that there are “exceptions,” but left for the litigation’s outcome to address them.[3]

Wilcox and Harris invoked the specter of Trump’s removing, without cause, members of the Federal Reserve’s Board of Governors. Felonious Trump has intimated he wanted to fire Jerome Powell, but has for the while backed off his threats, after the stock market tanked in response to his palavering. The Court went out of its way to distinguish the Federal Reserve as “a uniquely structured, quasi-private entity that follows in the distinct historical tradition of the First and Second Banks of the United States.”[4] All the independent agencies, however, are uniquely structured and designed so as not to be under the complete control of the president.

In dissent, Justice Elena Kagan, joined by Justices Sotomayor and Jackson, blasted her colleagues for using the court’s emergency docket to make a significant statement about an issue with implications for the fundamental structure of the federal government. The order, she wrote, essentially allows Trump to overrule the court’s 1935 decision in Humphrey’s Executor [5] “by fiat,” at least until the justices eventually take up the case. In the meanwhile, the Court takes up the surrender monkey posture of some of our leading law firms.

Justice Kagan understandably emphasized the abandonment of precedent in obeisance to Trump, as well as its ignoring and abandoning the legitimate interests of Congress in fashioning an independent agency. Justice Kagan also noted that the Court’s ruling on the interlocutory stay threw out “the presumption of constitutionality which attaches to every Act of Congress,” as somehow unworthy of consideration in an equitable analysis of the stay.

Although Justice Kagan enjoyed the better grounded argument, the dissent did not go far enough. Her dissent never actually identified the full range of executive branch interests at stake. The NLRB and the MSPB were created by statutes, passed by Congress, but which presidents signed.

In 1935, Congress passed the National Labor Relations Act to advance a policy encouraging collective bargaining. The Act was signed into law by President Franklin Roosevelt. The NLRB was created by the Act, passed by Congress, and made law by the executive.

Similarly, the Merit Systems Protection Board is an independent, quasi-judicial agency that protects the federal merit system. The Board was created by statute, and was codified by the Civil Service Reform Act of 1978, Public Law No. 95-454. This legislation was signed into law by President Jimmy Carter.

Executive power was involved in creating both boards, and in specifying the protections that board members would enjoy in doing their jobs. The firings by Felonious Trump were thus in derogation of executive power, as much as they were of legislative power. So once again, the Court has allowed Felonious Trump to ignore law that previous presidents, who exercised their executive power to create the for-cause protections. The executive may be unitary, but it is bound by laws that it enacts in conjunction with the legislature. The logic of the Court’s position implies that there is no limit to a president’s power to ignore statutory law.

[1] Trump v. Wilcox, ___ S.Ct.___, 605 U. S. ____ (May 22, 2025) [Slip op.]. See Nina Totenberg, “Supreme Court allows Trump to fire members of independent agency boards — for now,” Nat’l Public Radio (May 22, 2025).

[2] Slip op. at 1.

[3] Id. (“Because the Constitution vests the executive power in the President, he may remove without cause executive officers who exercise that power on his behalf, subject to narrow exceptions recognized by our precedents.”).

[4] Slip at 2.

[5] Humphrey’s Executor v. United States, 295 U. S. 602 (1935).

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Judging Science Symposium

May 25th, 2025

While waiting for the much delayed fourth edition of the Reference Manual on Scientific Evidence, you may want to take a look at a recent law review issue on expert witnesses issues. Back in November 2024, the Columbia Science & Technology Law Review held its symposium at the Columbia Law Review on “Judging Science.” The symposium explored current judicial practice for, and treatment of, scientific expert witness testimony in the United States. Because the symposium took place at Columbia, we can expect any number of antic proposals for reform, as well.

Among the commentators on the presentations were Hon. Jed S. Rakoff, Judge on the Southern District of New York,[1] and the notorious Provost David Madigan, from Northeastern University.[2]

The current issue (vol. 26, no.2) of the Columbia Science and Technology Law Review, released on May 23, 2025, contains papers originally presented at the symposium:

Edith Beerdsen, “Unsticking Litigation Science.”

Edward Cheng, “Expert Histories.”

Shari Seidman Diamond & Richard Lempert, “How Experts View the Legal System’s Use of Scientific Evidence.”

David Faigman, “Overcoming Judicial Innumeracy.”

Maura Grossman & Paul Grimm, “Judicial Approaches to Acknowledged and Unacknowledged AI-Generated Evidence.”

Valerie Hans, “Juries Judging Science.”

Enjoy the beach reading!

[1] See Schachtman, “Scientific illiteracy among the judiciary,” Tortini (Feb. 29, 2012).

[2] See, e.g., In re Accutane Litig., No. 271(MCL), 2015 WL 753674 (N.J. Super., Law Div., Atlantic Cty., Feb. 20, 2015) (excluding plaintiffs’ expert witness David Madigan); In re Incretin-Based Therapies Prods. Liab. Litig., 524 F. Supp. 3d 1007 (S.D. Cal. 2021), aff’d, No. 21-55342, 2022 WL 898595 (9th Cir. Mar. 28, 2022) (per curiam). Provost Madigan is stepping down from his position next month. Sonel Cutler, Zoe MacDiarmid & Kate Armanini, “Northeastern Provost David Madigan to step down in June,” The Huntington News (Jan. 16, 2025).

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