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A New Year, A New Reference Manual

January 5th, 2026

The fourth edition of the Reference Manual on Scientific Evidence was quietly released in the waning hours of 2025, in the twilight of American democracy.[1] The Manual had been slated to be published in 2023, but that date slid to 2024, and then to 2025.  Perhaps the change in directorship of the Federal Judicial Center slowed things up. (Judge Robin Rosenberg of Zantac fame is now the Director)

The new volume is available for download at:

https://www.nationalacademies.org/publications/26919

Although I was a reviewer of one chapter of the Manual, I am just seeing this new edition for the first time today. The basic structure of the volume has not changed, although it has now grown to over 1,600 pages. Many of the key chapters on statistics, epidemiology, toxicology, and medical testimony are carried over from previous editions, with some new authors added and some previous authors no longer participating. In addition, there are some new chapters on exposure science, artificial intelligence, climate science, mental health, neuroscience, and eyewitness identification.

The individual chapters and authors in the new edition of the Manual are:

Liesa L. Richter & Daniel J. Capra, The Admissibility of Expert Testimony, at 1.

Michael Weisberg & Anastasia Thanukos, How Science Works, at 47

Valena E. Beety, Jane Campbell Moriarty, & Andrea L. Roth, Reference Guide on Forensic Feature Comparison Evidence, at 113

David H. Kaye, Reference Guide on Human DNA Identification Evidence, at 207

Thomas D. Albright & Brandon L. Garrett, Reference Guide on Eyewitness Identification, at 361

David H. Kaye & Hal S. Stern, Reference Guide on Statistics and Research Methods, at 463

Daniel L. Rubinfeld & David Card, Reference Guide on Multiple Regression and Advanced Statistical Models, at 577

Shari Seidman Diamond, Matthew Kugler, & James N. Druckman, Reference Guide on Survey Research, at 681

Mark A. Allen, Carlos Brain, & Filipe Lacerda, Reference Guide on Estimation of Economic Damages, at 749

Prologue to the Reference Guide on Exposure Science and Exposure Assessment, the Reference Guide on Epidemiology, and the Reference Guide on Toxicology, at 829i

Elizabeth Marder & Joseph V. Rodricks, Reference Guide on Exposure Science and Exposure Assessment, at 831

Steve C. Gold, Michael D. Green, Jonathan Chevrier, & Brenda Eskenazi, Reference Guide on Epidemiology, at 897

David L. Eaton, Bernard D. Goldstein, & Mary Sue Henifin, Reference Guide on Toxicology, at 1027

John B. Wong, Lawrence O. Gostin, & Oscar A. Cabrera, Reference Guide on Medical Testimony, at 1105

Henry T. Greely & Nita A. Farahany, Reference Guide on Neuroscience, at 1185

Kirk Heilbrun, David DeMatteo, & Paul S. Appelbaum, Reference Guide on Mental Health Evidence, at 1269

Chaouki T. Abdallah, Bert Black, & Edl Schamiloglu, Reference Guide on Engineering, at 1353

Brian N. Levine, Joanne Pasquarelli, & Clay Shields, Reference Guide on Computer Science, at 1409

James E. Baker & Laurie N. Hobart, Reference Guide on Artificial Intelligence, at 1481

Jessica Wentz & Radley Horton, Reference Guide on Climate Science, at 1561

Some quick comments on changes in authorship in some of the chapters. Bernard Goldstein, a member of the dodgy Collegium Ramazzini, remains an author of the toxicology chapter in the new edition. David Eaton, however, has been added. Professor Eaton was the president of the Society of Toxicology for many years, and perhaps he has brought some balance to the new edition’s work on toxicology.

An author of the statistics chapter, David Kaye, is also the sole author of the chapter on DNA evidence. Professor Kaye is a distinguished scholar of DNA evidence with serious statistical expertise. David Freedman had been a co-author of the statistics chapter in the third edition, but sadly Professor Freedman died before the third edition was published. Freedman is replaced by Hal Stern, an accomplished statistician from the University of California.

The chapter on epidemiology lost Leon Gordis, who died in 2015. The chapter in the fourth edition has the return of law professors Steve C. Gold and Michael D. Green, whose pro-plaintiff biases are well known, along with two new authors, epidemiology professors Jonathan Chevrier, & Brenda Eskenazi. Like Goldstein, Eskenazi is a fellow of the Collegium Ramazzini.

The Reference Manual, for better or worse, has had substantial influence on the litigation of scientific and technical issues in federal court, and in some state courts as well. I hope to write more substantively about the new edition in 2026.

[1] National Academies of Sciences, Engineering, and Medicine & Federal Judicial Center, Reference Manual on Scientific Evidence (4th ed. 2025).

Posted in Causation, Expert Witnesses, Reference Manual on Scientific Evidence, Rule 702 | 1 Comment »

Specific Causation – The Process of Elimination

September 24th, 2025

Specific causation causes some courts to become costive, and sometimes, courts overuse so-called differential etiology as a laxative. The phrase “differential etiology” is an analogy to differential diagnosis, the reasoning process by which clinicians assess the identity of a disease or disorder. Differential etiology, like laxatives, can be overused and misused.

Last month, the Ninth Circuit affirmed a district court’s summary judgment in a glyphosate case. Engilis v. Monsanto Co., No. 23-4201, D.C. No. 3:19-cv-07859-VC (9th Cir. August 12, 2025). The trial court found that plaintiff’s expert witness’s differential etiology was unreliable because the putative expert witness acknowledged that obesity could be a cause of plaintiff’s disease, but then failed reliably to rule out obesity as a differential etiology. Instead, the excluded expert witness glibly inferred that glyphosate was a cause of plaintiff’s cancer. The trial and appellate courts were faced with a great example of invalid, motivated reasoning, or the lack of reasoning.

The Ninth Circuit’s affirmance was significant because it clearly acknowledged that there was no presumption of admissibility, and that the district court was well within its discretion to find that the proffered expert witness opinion had failed to meet the requirements of Rule 702.[1]

The decision in Engilis was simple and straightforward; it was based upon specific or individual causation or its absence. In cases involving diseases with multiple potential causes, none of which is necessary for the outcome, an exposure or lifestyle factor may be capable of causing a particular disease, but that factor may not have played a causal role in everyone who experienced the exposure or lifestyle factor and who developed the disease. (Not everyone who smoked cigarettes develops lung cancer, and not all lung cancer patients smoked.) Courts and litigants are thus left with the puzzle of individual causation.

In a case such as Engilis, courts can basically assume, arguendo, that glyphosate can cause the claimed outcome (Non-Hodgkin’s Lymphoma or NHL), but then insist that there is competent and sufficient evidence to show that the claimant’s specific case of NHL was caused by the claimed exposure.

Some courts and commentators have suggested that a process of “differential etiology, by analogy to differential diagnosis, can get a claimant to the finish line. This attempted solution assumes arguendo that glyphosate can cause NHL, but then it still must resolve whether this specific case of NHL (or whatever claimed) was caused by the claimed exposure.

As suggested above, differential etiology is something like constipation, which is resolved by the process of elimination. Formally, the reasoning process is an “iterative disjunctive syllogism.” We start with an exhaustive listing of the possible established general causes of the claimed disease:

A or B or C (exhausting the possible general causes of the claimed disease).

Because the diseases may multifactorial, the set of disjuncts may be more complex:

A or B or C or A*B or B*C or A*C or A*B*C.

But if the claimant had never been exposed to A, we can deduce:

B or C or B*C.

And if the claimant had never been exposed to B, we can infer that:

C.

And if C is the tortogen under investigation, for which general causation was established, the claimant would have an unequivocal submissible case to the jury.

Of course many diseases have unknown causes, so-called idiopathic or sporadic cases.  In such instances, any proper differential etiology must include a disjunct D, for idiopathic cause. We can see that the iterative disjunctive syllogism in such cases leaves us with uneliminated D in some of the remaining disjuncts, and the claimant cannot reach an unequivocal conclusion in support of his claim.

There may perhaps be a solution to this problem that turns on the effect size, and the probability of attribution associated with each uneliminated disjunct, but that is a story for another day.

[1] See Paul Driessen, “Nation’s most liberal court rejects plaintiff expert’s claims that glyphosate caused couple’s cancer,” Eurasia Review (Sept. 23, 2025).

Posted in Causation, Expert Witnesses, Rule 702 | No Comments »

Acetaminophen & Autism – Prada Review Misleadingly Claims to Be NIH Funded

September 9th, 2025

A few weeks ago, four scientists published what they called a “navigation guide” systematic review on acetaminophen use and autism.[1] The last named author, Andrea A. Baccarelli, is an environmental epidemiologist, who has been an expert witness for plaintiffs’ counsel in lawsuits against the manufacturers and sellers of acetaminophen. Another author, Beate Ritz, frequently testifies for the lawsuit industry in cases against various manufacturing industries. A third author, Ann Z. Bauer, was the lead author of a [faux] “consensus statement” that invoked the precautionary principle to call for limits on the use of acetaminophen (N-acetyl-p-aminophenol or APAP) by pregnant women, on grounds that such use may increase the risks of neurodevelopmental (including autism), reproductive and urogenital disorders.[2] The lead author was Diddier Prada, who works in Manhattan, at the Icahn School of Medicine at Mount Sinai, in the environmental and climate science department, within the Institute for Health Equity Research. The Mount Sinai website describes Dr. Diddier Prada as an environmental and molecular epidemiologist who focuses on the role of environmental toxicants in age-related conditions

Curious readers might wonder how someone whose interest is in environmental issues and “health equity” became involved in a review of pharmaco-epidemiology and teratology. The flavor of systematic review deployed in the paper, “navigation guide,” originated and has had limited use in the field of environmental issues. To my knowledge, so-called navigation guides have never been used previously in pharmaco-epidemiologic or teratologic controversies.[3]

The Prada paper and its deployment of a “navigation guide” systematic review deserve greater critical scrutiny.  In this post, however, I want to address some peripheral issues, such as “competing interests” and misleading claims about the paper’s having been NIH funded.

Only Dr. Baccarelli disclosed a potential conflict of interest, in a statement that many would judge to be anemic:

“Dr. Baccarelli served as an expert witness for the plaintiff’s legal team on matters of general causation involving acetaminophen use during pregnancy and its potential links to neurodevelopmental disorders. This involvement may be perceived as a conflict of interest regarding the information presented in this paper on acetaminophen and neurodevelopmental outcomes. Dr. Baccarelli has made every effort to ensure that this current work—like his past work as an expert witness on this matter—was conducted with the highest standards of scientific integrity and objectivity.”

The disclosure fails to mention whether Dr. Baccarelli was compensated for his playing on the “plaintiff’s legal team,” and if so, then how much. Using the passive voice, he suggests that this work might be perceived as a conflict of interest, when surely he knows that it is a serious issue. If industry scientists working on the relevant issue had published, they surely would be accused of having had a conflict.

Dr. Baccarelli self-servingly, falsely, and with epistemic arrogance, asserts that he made every effort in this paper, and in his past work as an expert witness, to conform to the “highest standards of scientific integrity and objectivity.” Despite his best efforts to be “scientific,” Baccarelli’s work failed critical scrutiny in the multi-district litigation that consolidated acetaminophen cases for pre-trial handling. In that litigation, the defense challenged Dr. Baccarelli’s opinions under Rule 702, for their lack of validity. In an extensive, closely reasoned opinion, federal district court judge Denise Cote ruled that Dr. Baccarelli’s proffered opinions failed to meet the relevance and reliability standards of federal law.[4]

The MDL court easily found that Dr. Baccarelli was qualified to provide an opinion on epidemiology, although the focus of his career has been on environmental issues. Baccarelli’s substantive problem was that he deviated from accepted and valid methods of causal inference by cherry picking different results and outcomes across multiple studies. Baccarelli’s sophistical trick was to advance a “transdiagnostic” analysis that lumps an already heterogenous autism spectrum disorder (ASD), with attention-deficit hyperactivity disorder (ADHD), and a grab bag of “other neurodevelopmental disorders.” If a study found a putative association with only one of the three end points, Baccarelli would claim success on all three. Baccarelli avoided conducting separate ASD and ADHD analyses, and he cherry picked the end points that supported his pre-determined conclusions.

Judge Cote found that the transdiagnostic analyses advanced by plaintiffs’ expert witnesses, including Baccarelli, obscured and obfuscated more than they informed the causal inquiry.[5] The court’s analysis casts considerable shade upon Baccarelli’s self-serving claim to have used “the highest standards of scientific integrity and objectivity.” Judge Cote barred Baccarelli and the other members of the plaintiffs’ “expert team” from testifying.

Conspicuously absent from the conflict disclosure section of the Prada article was any mention of the litigation work of co-author Beate Ritz. In 2007, Ritz became a fellow of the Collegium Ramazzini, which functions in support of the lawsuit industry much as the scientists of the Tobacco Institute supported tobacco legal defense efforts in times past. Ritz’s fellowship in the Collegium makes her a full-fledged member of the Lobby and a supporter of the lawsuit industry.[6] Ritz has testified, for claimants, in cases involving claims of heavy metals in baby food, in cases involving claims that paraquat exposure caused Parkinson’s disease, and most notoriously for plaintiffs in glyphosate litigation, where her witnessing is often done for the Wisner Baum lawfirm that employs the son of Robert F. Kennedy, Jr.[7]

The conflict of interest disclosure statement is hardly the only misleading aspect of the Prada paper. At the end of the paper, the authors state, with respect to funding that their “study was supported by NIH (R35ES031688; U54CA267776).” Some people may incorrectly believe that the Prada review was directly sponsored and funded by the National Institutes of Health.  Nothing could be further from the truth.

The research grant referenced, R35ES031688, is a National Institute of Environmental Health Sciences (NIEHS) research grant. The curious reader might inquire what whether and why the NIEHS would be concerned about a pharmacological issue. The short answer is that the NIEHS is not, and that this grant has nothing to do with children’s neurological status in relation to their mother’s ingestion of acetaminophen.

The NIEHS award this research grant to Andrea Baccarelli, while he was at Columbia University, for his project “Extracellular Vesicles in Environmental Epidemiology Studies of Aging.” The research focuses on extracellular vesicles (EVs) and their role in environmental health, particularly as it relates to aging. What Baccarelli promised to do with this NIEHS grant was to study the effects of air pollution on accelerated brain aging, and disease states such as dementia. Baccarelli noted that his focus would be on intra-cellular communication enabled by extracellular vesicles, in reaction to air pollution. The described research would understandably be viewed as potentially relevant to the NIEHS mission statement, but it has nothing to do with autism among children of women who ingested acetaminophen during pregnancy.  The phrases “extracellular vesicles” and “air pollution” do not appear in the Prada review.

The second grant listed under funding for the Prada review was U54CA267776. The U54 designation marks this as a career award, not specific to a specific topic or this published work. Ironically, the grant is a diversity, equity, and inclusion grant to the Mount Sinai Icahn School of Medicine, in Manhattan. The Icahn School has long had one of the most ethically, racially, culturally diverse faculties of any medical school, and hardly needs financial incentives to hire minority physicians and scientists.

The NIH awarded grant U54CA267776 for “Cohort Cluster Hiring Initiative at Icahn School of Medicine at Mount Sinai.” The NIH describes the grant as aiming to reduce “[t]he barriers to research and career success for underrepresented groups in academic medicine.” The text of the U54 grant is written largely in bureaucratic jargon, which may require a degree in DEI to understand fully. What is abundantly clear is that nothing in this U54 grant, or in its stated criteria for evaluation, has anything to do with studying the teratologic potential of acetaminophen.

What so far has escaped the media’s attention is that Prada and colleagues did not have NIH (or NIEHS) support for their acetaminophen review. They had career-level support for DEI purposes, or perhaps general “walking-around” money for research on environmental pollution and brain aging, which has nothing to do with the subject of their navigation guide review. The authors of the Prada review never prepared a study proposal related to acetaminophen for evaluation by a funding committee at NIH. The authors never submitted a protocol to the NIH, and the NIH provided no peer review or guidance for the authors’ acetaminophen review. In short, there is nothing that marks the Prada review as an NIH work product other than the over-claiming of the authors with respect to funding sources.

The Prada review has attracted a lot of attention in the media and from the worm-brained Secretary of Health and Human Services. An article in the Washington Post described the Prada review as NIH funded, which tracks the paper’s misleading disclosure.[8] The media no doubt jumped on the publication of the Prada review last month because Secretary Kennedy promised to reveal the cause of autism by September. We can imagine that Kennedy will be tempted to embrace the Prada review because he can falsely mischaracterize it as an NIH-funded review.

Not only is the funding claim dodgy, but so is the suggestion that the review supports a conclusion of causation between maternal ingestion of acetaminophen and autism in children. The lead author, Dr. Diddier Prada, noted the frequent confusion between correlation and causation and explicitly stated the authors of the review “cannot answer the question about causation.”[9]

[1] Diddier Prada, Beate Ritz, Ann Z. Bauer and Andrea A. Baccarelli, “Evaluation of the evidence on acetaminophen use and neurodevelopmental disorders using the Navigation Guide methodology,” 24 Envt’l Health 56 (2025).

[2] Ann Z. Bauer et al., “Paracetamol Use During Pregnancy — A Call for Precautionary Action,” 17 Nature Rev. Endocrinology 757 (2021).

[3] See Tracey J. Woodruff, Patrice Sutton, and The Navigation Guide Work Group, “An Evidence-Based Medicine Methodology To Bridge The Gap Between Clinical And Environmental Health Sciences,” 30 Health Affairs 931 (May 2011).

[4] In re Acetaminophen ASD-ADHD Prods. Liab. Litig., 707 F. Supp. 3d 309, 2023 WL 8711617 (S.D.N.Y. 2023) (Cote, J.).

[5] Id. at 334.

[6] See F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997).

[7] See, e.g., In re Roundup Prods. Liab. Litig., 390 F. Supp. 3d 1102 (2018); Barrera v. Monsanto Co., Del. Super. Ct. (May 31, 2019); Pilliod v. Monsanto Co., 67 Cal. App. 5th 591, 282 Cal. Rptr. 3d 679 (2021). See also Dan Charles, “Taking the stand: For scientists, going to court as an expert witness brings risks and rewards,” 383 Science 942 (Feb. 29, 2024) (quoting Ritz as suggesting that she was reluctant to get involved as an expert witnesses).

[8] Ariana Eunjung Cha, Caitlin Gilbert and Lauren Weber, “MAHA activists have been pushing for more investigation into use of the common pain killer during pregnancy,” Wash. Post (Sept. 5, 2025). See also Liz Essley Whyte & Nidhi Subbaraman, “RFK Jr., HHS to Link Autism to Tylenol Use in Pregnancy and Folate Deficiencies,” Wall St. J. (Sept. 5, 2025).

[9] Jess Steier, “Saturday Morning Thoughts on the Tylenol-Autism News: The public health whiplash continues as we play another round of ‘autism cause’ roulette,” Unbiased Science (substack) (Sept. 06, 2025).

Posted in Causation, Conflicts of Interest, Expert Witnesses, Rule 702, Scientific Evidence | 5 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).

Posted in Expert Witness Discovery, Expert Witnesses, Reference Manual on Scientific Evidence, Rule 702, Scientific Publishing | No Comments »

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 »

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).

Posted in Expert Witnesses, Rule 702, Scientific Evidence, statistical evidence | No Comments »

ABA Publishes Bad Advice on How to Defeat So-Called Daubert Motions

January 3rd, 2025

There are some science expert witnesses, such as Ronald Melnick and David Michaels, who testify for the lawsuit industry, who seem to believe that the so-called “Daubert” motion is an immoral attempt to exclude important scientific opinions at trial.[1] Melnick and Michaels and their ilk appear to have persuaded themselves that they should have the unfettered right to influence the fact-finding process with their opinions, regardless of validity concerns.

Most lawyers approach motions to exclude expert witness opinion testimony from an adversarial perspective. They are duty bound to probe their adversaries’ expert witnesses’ opinions for legally fatal invalidity. With respect to their own expert witnesses, the last thing that lawyers wish to happen on their watch is for the court to exclude an expert witness whom they selected and shepherded in the litigation process. Lawyers do their best, but they usually admit, at least in some cases, that from the umpire’s perspective they should lose.

A recent article published by the American Bar Association (ABA) offers advice how to defeat an adversary’s so-called Daubert motion.[2] The article does not admit that sometimes the motion might be well taken, and so it fits into the Swiftean view of lawyers as “a society of men among us, bred up from their youth in the art of proving, by words multiplied for the purpose, that white is black, and black is white, according as they are paid.”[3]

Perhaps we should not be too harsh in criticizing an article on how to defeat a Daubert motion that fails to ask whether the opposition is epistemically warranted. Still, this recent offering seriously misleads young lawyers who seek to defeat evidentiary challenges to their expert witnesses.

The first problem is that this how-to article perpetuates the mistake that there is even a thing called a Daubert challenge.  The Daubert case was decided over 30 years ago, based upon a version of a congressionally approved rule that is no longer in effect.[4] The holding of the case was simply that Congress, in enacting the original Rule 702, did not incorporate the holding of Frye v. United States into the promulgated rule.[5]

There was, of course, some interesting and important dicta in the Daubert opinion, but the authors do a disservice to the bar to repeat the dicta as though they were good law. The issue of the meaning of the original Rule 702 was addressed again multiple times after Daubert, in ways that certainly affected the oft-quoted dicta, and which led to two substantive revisions of Rule 702. We are thus now so far removed from the Daubert case itself that it really is time to stop the mindless recitation of its dicta.

What follows the discussion of the Daubert case, in this how-to article, is no less discouraging. The authors offer five tips, each of which is problematic.

“1. The Best Defense Is a Good Offense—Vet Offered Experts Thoroughly”

The authors advise that “Knowing the potential weaknesses of an expert’s background can help your client guard against Daubert challenges early by picking the right expert to avoid impeachment issues, or by allowing you to minimize the offered expert’s weaknesses through the expert’s report and opinion, or other testimony.”

True, true, and immaterial. Impeachment of an otherwise qualified witness is indeed an important consideration for trial, but it has nothing to do with Rule 702. Indeed, evaluating how expert witnesses will hold up to cross-examination assume that their testimony will be admitted.  To the extent that Rule 702 requires a witness qualified by education, experience, or training, the bar for qualification is set very low. Very few Rule 702 motions challenge proffered expert witnesses on grounds that they are unqualified.

“2. Research Standards and Methodologies Commonly Used and Accepted by Courts in Similar Fact Patterns”

The authors somewhat more relevant advise that “[n]ew lawyers can also assist with defending against Daubert challenges by thoroughly researching expert methodologies that have been previously accepted by courts in similar situations. If a court has previously accepted a methodology that your expert expects to use, this will demonstrate that the methodology is reliable and commonly accepted in the expert’s given field.”

There is, of course, a sense in which this advice is true, but still the Sinatra article is very misleading. There are some cases that turn on the use of crack-pot methodologies, and these methodologies should be avoided. Most expert witnesses, however, are smart enough to dress up their opinions to appear to have been reached by the use of a recognizable, generally accepted methodology. In litigation over alleged chronic health effects, plaintiffs’ witnesses will invoke Bradford Hill’s considerations for determining whether an association is causal. Finding cases that find opinions based upon such considerations to be admissible, however will not protect expert witnesses who have not faithfully applied the considerations to the facts of the case at hand. To channel Seinfeld, it is not good enough for a restaurant to accept reservations; it must also honor those reservations.

“3. Highlight Your Expert Witnesses’ Credentials.”

Here again, the authors offer advice that is largely irrelevant to prosecuting or defending a Rule 702 motion: “Once your team decides to work with a particular expert to support your client, new lawyers can further assist in fending off Daubert challenges by highlighting your expert’s relevant credentials wherever appropriate.” Many successful Rule 702 motions have excluded the proffered opinion testimony of world-renown experts, which speaks volumes about how such experts think they can get away with sub-par work because it is only litigation.

“4. Point Out the Timing of the Daubert Challenge”

The authors advise that a Rule 702 motion might be defeated if made too late in the proceedings: “If a Daubert challenge is made at a late stage in the litigation, you may be able to overcome the challenge by arguing that your adversary has raised the issues too late in the proceedings.”

Tellingly, the authors cite no cases for this remarkable proposition, which implies that failing to make a pre-trial evidentiary challenge is a waiver of a trial objection. The proposition is wrong; there is nothing in Rule 702 that requires the motion to brought in advance of trial. There are, of course, many practical reasons why a party would wish to lodge the motion before trial, the most important of which is that the outcome of the motion might result in the entry of summary judgment and dismissal of the lawsuit before trial. Judicial and party economies shout for the motion to be made before trial, but not until after parties have the procedural ability to substitute new expert witness opinion. Additionally, a judge may set the timing of a Rule 702, which will then become part of a pre-trial order. Rule 702 is, however, a rule of admissibility, and nothing in the rule or the case law prevents a motion from being brought in the middle of a trial. Moreover, if a motion were brought before trial, and denied, the loser would have to assert the objection again, or make a motion to strike testimony, at trial in order to preserve the denial for appeal.

There is also a large difference in what may be done in a pre-trial Rule 702 motion than can be accomplished at trial. The moving party may present testimony, as well as materials that are not themselves otherwise admissible at trial, in support of the motion. Rule 702 motions can sometimes take days of courtroom time, and the trial judge has the opportunity to appreciate the nuances of what may be a complex argument about validity or sufficiency of evidence. What is glaringly wrong, however, in the authors’ argument is that pre-trial discovery really must be over for a Rule 702 motion to be effective and timely.

“5. Highlight Why the Expert’s Testimony Is Relevant and Will Aid the Fact Finder”

The authors urge opponents to stress relevancy and helpfulness. Relevancy is a fairly trivial requirement and not part of Rule 702 (or “Daubert”) itself. Helpfulness, or aiding the fact finder, is a measure of admissibility, but it stands to reason that opinion testimony that lacks a valid and sufficient foundation can never really be helpful to or be relied upon by the finder of fact.

Perhaps most egregious in this ABA article is its complete failure to note that the relevant rule is a statute that has been only recently amended. The words of the statute should be the starting point for any lawyer, young or old, as well as for judges. Given that the statute was just amended, the authors of this ABA “young lawyers” advice might well have suggested to their readers that they actually read and comply with the rule, and that they spend a few minutes reading the Rules Advisory Committee notes on why the rule was amended.

Social media platforms enjoy substantial immunity, under Section 230 of the Communications Decency Act, for the crazy stuff published by users of their platforms. I don’t know whether the ABA has potential legal liability for what it publishes, but it certainly has an ethical responsibility not to disseminate bad advice.

[1] Ronald L. Melnick, “A Daubert Motion: A Legal Strategy to Exclude Essential Scientific Evidence in Toxic Tort Litigation,” 95 Am. J. Pub. Health S30 (2005) (“However, if a judge does not have adequate training or experience in dealing with scientific uncertainty, understand the full value or limit of currently used methodologies, or recognize hidden assumptions, misrepresentations of scientific data, or the strengths of scientific inferences, he or she may reach an incorrect decision on the reliability and relevance of evidence linking environmental factors to human disease.”).

[2] Maria Sinatra and Gianna E Cricco-Lizza, “5 Tips for New Lawyers to Defeat Daubert Challenges,” Am. Bar Ass’ n (Oct. 4, 2024).

[3] Jonathan Swift, Gulliver’s Travels: Travels into Several Remote Nations of the World, Part IV, Chapter 5 (1727).

[4] Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

[5] Frye v. United States, 293 F. 1013 (D.C. Cir. 1923).

Posted in Expert Witnesses, Rule 702 | 1 Comment »

Manufacturing Consensus

December 9th, 2024

The lawsuit industry is fond of claiming that it is victimized by manufactured doubt;[1] its response has often been to manufacture consensus.[2] Doubt and assent are real psychological phenomena that are removed from the more important epistemic question whether the propositions doubted or agreed to are true, or worthy of belief.

Since at least the adoption of Federal Rule of Evidence 702, the law of evidence in federal courts, and in some state courts, has come to realize that expert witness opinion testimony must be judged by epistemic criteria. Implicit in such judging is that reviewing courts, and finders of fact, must assess the validity of facts and data relied upon, and inferences drawn, by expert witnesses.

Professor Edward Cheng has argued that judges and jurors are epistemically incompetent to engage in the tasks required of them by Rule 702.[3] Cheng would replace Rule 702 with what he calls a consensus rule that requires judges and jurors to assess only whether there is a scientific consensus on general scientific propositions such as claims of causality between a particular exposure and a specific disease outcome.

Cheng’s proposal is not the law; it never has been the law; and it will never be the law. Yet, law professors must make a living, and novelty is often the coin of the academic realm.[4] Cheng teaches at Vanderbilt Law School, and a few years ago, he started a podcast, Excited Utterances, which features some insightful and some antic proposals from the law school professoriate. The podcast is hosted by Cheng, or sometimes by his protégé, G. Alexander Nunn (“Alex”), who is now Associate Professor of Law at Texas A&M University School of Law

Cheng’s consensus rule has not gained any traction in the law, but it has attracted support from a few like-minded academics. David Caudill, a Professor of Law, at the Villanova University Charles Widger School of Law, has sponsored a symposium of supporters.[5] This year, Caudill has published another publication that largely endorses Cheng’s consensus rule.[6]

Back in October 2024, Cheng hosted Caudill on Excited Utterances, to talk about his support for Cheng’s consensus rule. The podcast website blurb describes Caudill as having critiqued and improved upon Cheng’s “proposal to have courts defer to expert consensus rather than screening expert evidence through Daubert.” [This is, of course, incorrect. Daubert was one case that interpreted a statute that has since been substantively revised twice. The principle of charity suggests that Nunn meant Federal Rule of Evidence 702.] Alex Nunn conducted the interview of Caudill, which was followed by some comments from Cheng.

If you are averse to reading law review articles, you may find Nunn’s interview of Caudill a more digestible, and time-saving, way to hear a précis of the Cheng-Caudill assault on scientific fact finding in court. You will have to tolerate, however, Nunn’s irrational exuberance over how the consensus rule is “cutting edge,” and “wide ranging,” and Caudill’s endorsement of the consensus rule as “really cool,” and his dismissal of the Daubert case as “infamous.”

Like Cheng, Caudill believes that we can escape the pushing and shoving over data and validity by becoming nose counters. The task, however, will not be straightforward. Many litigations begin before there is any consensus on one side or the other. No one seems to agree how to handle such situations. Some litigations begin with an apparent consensus, but then shift dramatically with the publication of a mega-trial or a definitive systematic review. Some scientific issues remain intractable to easy resolution, and the only consensuses exist within partisan enclaves.

Tellingly, Caudill moves from the need to discern “consensus” to mere “majority rule.” Having litigated health effects claims for 40 years or so, I have no idea of how we tally support for one view over another. Worse yet, Caudill acknowledges that judges and jurors will need expert assistance in identifying consensus. Perhaps litigants will indeed be reduced to calling librarians, historians, and sociologists of science, but such witnesses will not necessarily be able to access, interpret, and evaluate the underlying facts, data, and inferences to the controversy. Cheng and Caudill appear to view this willful blindness as a feature not a bug, but their whole enterprise works in derogation of the goal of evidence law to determine the truth of the matter.[7]

Robust consensus that exists over an extended period of time – in the face of severe testing of the challenged claim – may have some claim to track the truth of the matter. Cheng and Caudill, however, fail to deal with is the situation that results when the question is called among the real experts, and the tally is 51 to 49 percent. Or worse yet, 40% versus 38%, with 22% disclaiming having looked at the issue sufficiently. Cheng and Caudill are left with asking the fact finder to guess what the consensus will be when the scientific community sees the evidence that it has not yet studied or that does not yet exist.

Perhaps the most naïve feature of the Cheng-Caudill agenda is the notion that consensus bubbles up from the pool of real experts without partisan motivations. As though there is not already enough incentive to manufacture consensus, Cheng’s and Caudill’s approach will cause a proliferation of conferences that label themselves “consensus” forming meetings, which will result in self-serving declarations of – you guessed it – consensuses.[8]

Perhaps more important from a jurisprudential view is that the whole process of identifying a consensus has the normative goal of pushing listeners into believing that the consensus has the correct understanding so that they do not have to think very hard. We do not really care about the consensus; we care about the issue that underlies the alleged consensus. At best, when it exists, consensus is a proxy for truth. Without evidence, Caudill asserts that the proxy will be correct virtually all the time. In any event, a carefully reasoned and stated consensus view would virtually always make its way to the finder of fact in litigation in the form of a “learned treatise,” with which partisan expert witnesses would disagree at their peril.

[1] See, e.g., David Michaels, Doubt is Their Product: How Industry’s War on Science Threatens Your Health (2008); David Michaels, “Manufactured Uncertainty: Protecting Public Health in the Age of Contested Science and Product Defense,” 1076 Ann. N.Y. Acad. Sci. 149 (2006); David Michaels, “Mercenary Epidemiology – Data Reanalysis and Reinterpretation for Sponsors with Financial Interest in the Outcome,” 16 Ann. Epidemiol. 583 (2006); David Michaels & Celeste Monforton, “Manufacturing Uncertainty: Contested Science and the Protection of the Public’s Health and Environment,” 95 Amer. J. Public Health S39 (2005); David Michaels, “Doubt is their Product,” 292 Sci. Amer. 74 (June 2005).

[2] See generally Edward S. Herman & Noam Chomsky, Manufacturing Consent (1988); Schachtman, “The Rise of Agnothology as Conspiracy Theory,” Tortini (Aug. 21, 2022).

[3] Edward K. Cheng, “The Consensus Rule: A New Approach to Scientific Evidence,” 75 Vanderbilt L. Rev. 407 (2022); see Schachtman, “Cheng’s Proposed Consensus Rule for Expert Witnesses,” Tortini (Sept. 15, 2022); “Further Thoughts on Cheng’s Consensus Rule” Tortini (Oct. 3, 2022); “ Consensus Rule – Shadows of Validity,” Tortini (Apr. 26, 2023); “ Consenus is Not Science,” Tortini (Nov. 8, 2023).

[4] Of possible interest, David Madigan, a statistician who has frequently been involved in litigation for the lawsuit industry, and who has proffered some particularly dodgy analyses, was Professor Cheng’s doctoral dissertation advisor. See Schachtman, “Madigan’s Shenanigans & Wells Quelled in Incretin-Mimetic Cases,” Tortini (July 19, 2022); “David Madigan’s Graywashed Meta-Analysis in Taxotere MDL,” Tortini (June 19, 2020); “Disproportionality Analyses Misused by Lawsuit Industry,” Tortini (April 20, 2020); “Johnson of Accutane – Keeping the Gate in the Garden State,” Tortini (March 28, 2015).

[5] David S. Caudill, “The ‘Crisis of Expertise’ Reaches the Courtroom: An Introduction to the Symposium on, and a Response to, Edward Cheng’s Consensus Rule,” 67 Villanova L. Rev. 837 (2023).

[6] David S. Caudill, Harry Collins & Robert Evans, “Judges Should Be Discerning Consensus, Not Evaluating Scientific Expertise,” 92 Univ. Cinn. L. Rev. 1031 (2024).

[7] See, e.g., Jorge R Barrio, “Consensus Science and the Peer Review,” 11 Molecular Imaging & Biol. 293 (2009) (“scientific reviewers of journal articles or grant applications – typically in biomedical research – may use the term (e.g., ‘….it is the consensus in the field…’) often as a justification for shutting down ideas not associated with their beliefs.”); Yehoshua Socol, Yair Y Shaki & Moshe Yanovskiy, “Interests, Bias, and Consensus in Science and Regulation,” 17 Dose Response 1 (2019) (“While appealing to scientific consensus is a legitimate tool in public debate and regulatory decisions, such an appeal is illegitimate in scientific discussion itself.”); Neelay Trivedi, “Science is about Evidence, not Consensus,” The Stanford Rev. (Feb. 25, 2021).

[8] For a tendentious example of such a claim of manufactured consensus, see David Healy, “Manufacturing Consensus,” 34 The Hastings Center Report 52 (2004); David Healy, “Manufacturing Consensus,” 30 Culture, Medicine & Psychiatry 135 (2006).

Posted in Expert Witnesses, Rule 702, Scientific Evidence | 1 Comment »

Zhang’s Glyphosate Meta-Analysis Succumbs to Judicial Scrutiny

August 5th, 2024

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Postscript

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

天安门广场英雄万岁

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Posted in Causation, Confounding, Expert Witnesses, Meta-analysis, Rule 702, Rule 703, statistical evidence | 37 Comments »

David Egilman, Rest in Peace, Part 3

April 30th, 2024

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

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

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Posted in Cognitive Biases, Conflicts of Interest, Expert Witnesses, Public Nuisances, Scientific Publishing | 48 Comments »

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