TORTINI

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

A Π-Day Celebration of Irrational Numbers and Other Things – Philadelphia Glyphosate Litigation

March 14th, 2024

Science can often be more complicated and nuanced than we might like. Back in 1897, the Indiana legislature attempted to establish that π was equal to 3.2.[1] Sure, that was simpler and easier to use in calculations, but also wrong. The irreducible fact is that π is an irrational number, and Indiana’s attempt to change that fact was, well, irrational. And to celebrate irrationality, consider the lawsuit’s industry’s jihad against glyphosate, including its efforts to elevate a dodgy IARC evaluation, while suppressing evidence of glyphosate’s scientific exonerations

                                                 

After Bayer lost three consecutive glyphosate cases in Philadelphia last year, observers were scratching their heads over why the company had lost when the scientific evidence strongly supports the defense. The Philadelphia Court of Common Pleas, not to be confused with Common Fleas, can be a rough place for corporate defendants. The local newspapers, to the extent people still read newspapers, are insufferably slanted in their coverage of health claims.

The plaintiffs’ verdicts garnered a good deal of local media coverage in Philadelphia.[2] Defense verdicts generally receive no ink from sensationalist newspapers such as the Philadelphia Inquirer. Regardless, media accounts, both lay and legal, are generally inadequate to tell us what happened, or what went wrong in the court room. The defense losses could be attributable to partial judges or juries, or the difficulty in communicating subtle issues of scientific validity. Plaintiffs’ expert witnesses may seem more sure of themselves than defense experts, or plaintiffs’ counsel may connect better with juries primed by fear-mongering media. Without being in the courtroom, or at least studying trial transcripts, outside observers are challenged to explain fully jury verdicts that go against the scientific evidence. The one thing jury verdicts are not, however, are valid assessments of the strength of scientific evidence, inferences, and conclusions.

Although Philadelphia juries can be rough, they like to see a fight. (Remember Rocky.) It is not a place for genteel manners or delicate and subtle distinctions. Last week, Bayer broke its Philadelphia losing streak, with a win in Kline v. Monsanto Co.[3] Mr. Kline claimed that he developed Non-Hodgkin’s lymphoma (NHL) from his long-term use of Round-Up. The two-week trial, before Judge Ann Butchart, last week went to the jury, which deliberated two hours before returning a unanimous defense verdict. The jury found that the defendants, Monsanto and Nouryon Chemicals LLC, were not negligent, and that the plaintiff’s use of Roundup was not a factual cause of his lymphoma.[4]

Law360 reported that the Kline verdict was the first to follow a ruling on Valentine’s Day, February 14, 2024, which excluded any courtroom reference to the hazard evaluation of Glyphosate by the International Agency for Research on Cancer (IARC). The Law360 article indicated that the IARC found that glyphosate can cause cancer; except of course IARC has never reached such a conclusion.

The IARC working group evaluated the evidence for glyphosate and classified the substance as a category IIA carcinogen, which it labels as “probably” causing human cancer. This label sounds close to what might be useful in a courtroom, except that the IARC declares that “probably,” as used in is IIA classification does not mean what people generally, and lawyers and judges specifically, mean by the word probably.  For IARC, “probable” has no quantitative meaning.  In other words, for IARC, probable, a quantitative concept, which everyone understands to be measured on a scale from 0 to 1, or from 0% to 100%, is not quantitative. An IARC IIA classification could thus represent a posterior probability of 1% in favor of carcinogenicity (and 99% probable not a carcinogen). In other words, on whether glyphosate causes cancer in humans, IARC says maybe in its own made-up epistemic modality.

To find the idiosyncratic definition of “probable,” a diligent reader must go outside the monograph of interest to the so-called Preamble, a separate document, last revised in 2019. The first time the jury will hear of the IARC pronouncement will be in the plaintiff’s case, and if the defense wishes to inform the jury on the special, idiosyncratic meaning of IARC “probable,” they must do it on cross-examination of hostile plaintiffs’ witnesses, or wait longer until they present their own witnesses. Disclosing the IARC IIA classification hurts because the “probable” language lines up with what the trial judges will instruct the juries at the end of the case, when the jurors are told that they need not believe that the plaintiff has eliminated all doubt; they need only find that the plaintiff has shown that each element of his case is “probable,” or more likely than not, in order to prevail. Once the jury has heard “probable,” the defense will have a hard time putting the toothpaste back in the tube. Of course, this is why the lawsuit industry loves IARC evaluations, with its fallacies of semantical distortion.[5]

Although identifying the causes of a jury verdict is more difficult than even determining carcinogenicity, Rosemary Pinto, one of plaintiff Kline’s lawyers, suggested that the exclusion of the IARC evaluation sank her case:

“We’re very disappointed in the jury verdict, which we plan to appeal, based upon adverse rulings in advance of the trial that really kept core components of the evidence out of the case. These included the fact that the EPA safety evaluation of Roundup has been vacated, who IARC (the International Agency for Research on Cancer) is and the relevance of their finding that Roundup is a probable human carcinogen [sic], and also the allowance into evidence of findings by foreign regulatory agencies disguised as foreign scientists. All of those things collectively, we believe, tilted the trial in Monsanto’s favor, and it was inconsistent with the rulings in previous Roundup trials here in Philadelphia and across the country.”[6]

Pinto was involved in the case, and so she may have some insight into why the jury ruled as it did. Still, issuing this pronouncement before interviewing the jurors seems little more than wishcasting. As philosopher Harry Frankfurt explained, “the production of bullshit is stimulated whenever a person’s obligations or opportunities to speak about some topic exceed his knowledge of the facts that are relevant to that topic.”[7] Pinto’s real aim was revealed in her statement that the IARC review was “crucial evidence that juries should be hearing.”[8]  

What is the genesis of Pinto’s complaint about the exclusion of IARC’s conclusions? The Valentine’s Day Order, issued by Judge Joshua H. Roberts, who heads up the Philadelphia County mass tort court, provided that:

AND NOW, this 14th day of February, 2024, upon consideration of Defendants’ Motion to Clarify the Court’s January 4, 2024 Order on Plaintiffs Motion in Limine No. 5 to Exclude Foreign Regulatory Registrations and/or Approvals of Glyphosate, GBHs, and/or Roundup, Plaintiffs’ Response, and after oral argument, it is ORDERED as follows:

  1. The Court’s Order of January 4, 2024, is AMENDED to read as follows: [ … ] it is ORDERED that the Motion is GRANTED without prejudice to a party’s introduction of foreign scientific evidence, provided that the evidence is introduced through an expert witness who has been qualified pursuant to Pa. R. E. 702.

  2. The Court specifically amends its Order of January 4, 2024, to exclude reference to IARC, and any other foreign agency and/or foreign regulatory agency.

  3. The Court reiterates that no party may introduce any testimony or evidence regarding a foreign agency and/or foreign regulatory agency which may result in a mini-trial regarding the protocols, rules, and/or decision making process of the foreign agency and/or foreign regulatory agency. [fn1]

  4. The trial judge shall retain full discretion to make appropriate evidentiary rulings on the issues covered by this Order based on the testimony and evidence elicited at trial, including but not limited to whether a party or witness has “opened the door.”[9]

Now what was not covered in the legal media accounts was the curious irony that the exclusion of the IARC evaluation resulted from plaintiffs’ motion, an own goal of sorts. In previous Philadelphia trials, plaintiffs’ counsel vociferously objected to the defense counsel’s and experts’ references to the determinations by foreign regulators, such as European Union Assessment Group on Glyphosate (2017, 2022), Health Canada (2017), European Food Safety Authority (2017, 2023), Australian Pesticides and Veterinary Medicines Authority (2017), German Federal Institute for Risk Assessment (2019), and others, that rejected the IARC evaluation and reported that glyphosate has not been shown to be carcinogenic.[10]

The gravamen of the plaintiffs’ objection was that such regulatory determinations were hearsay, and that they resulted from various procedures, using various criteria, which would require explanation, and would be subject to litigants’ challenges.[11] In other words, for each regulatory agency’s determination, there would be a “mini-trial,” or a “trial within a trial,” about the validity and accuracy of the foreign agency’s assessment.

In the earlier Philadelphia trials, the plaintiffs’ objections were largely sustained, which created a significant evidentiary bias in the courtrooms. Plaintiffs’ expert witnesses could freely discuss the IARC glyphosate evaluation, but the defense and its experts could not discuss the many determinations of the safety of glyphosate. Jurors were apparently left with the erroneous impression that the IARC evaluation was a consensus view of the entire world’s scientific community.

Now plaintiffs’ objection has a point, even though it seems to prove too much and must ultimately fail. In a trial, each side has expert witnesses who can offer an opinion about the key causal issue, whether glyphosate can cause NHL, and whether it caused this plaintiff’s NHL. Each expert witness will have written a report that identifies the facts and data relied upon, and that explains the inferences drawn and conclusions reached. The adversary can challenge the validity of the data, inferences, and conclusions because the opposing expert witness will be subject to cross-examination.

The facts and data relied upon will, however, be “hearsay,” which will come from published studies not written by the expert witnesses at trial. There will be many aspects of the relied upon studies that will be taken on faith without the testimony of the study participants, their healthcare providers, or the scientists who collected the data, chose how to analyze the data, conducted the statistical and scientific analyses, and wrote up the methods and study findings. Permitting reliance upon any study thus allows for a “mini-trial” or a “trial within a trial,” on each study cited and relied upon by the testifying expert witnesses. This complexity involved in expert witness opinion testimony is one of the foundational reasons for Rule 702’s gatekeeping regime in federal court, and most state courts, but which is usually conspicuously absent in Pennsylvania courtrooms.

Furthermore, the plaintiffs’ objections to foreign regulatory determinations would apply to any review paper, and more important, it would apply to the IARC glyphosate monograph itself. After all, if expert witnesses are supposed to have reviewed the underlying studies themselves, and be competent to do so, and to have arrived at an opinion in some reliable way from the facts and data available, then they would have no need to advert to the IARC’s review on the general causation issue.  If an expert witness were allowed to invoke the IARC conclusion, presumably to bolster his or her own causation opinion, then the jury would need to resolve questions about:

  • who was on the working group;
  • how were working group members selected, or excluded;
  • how the working group arrived at its conclusion;
  • what did the working group rely upon, or not rely upon, and why,
  • what was the group’s method for synthesizing facts and data to reach its conclusion;
  • was the working group faithful to its stated methodology;
  • did the working group commit any errors of statistical or scientific judgment along the way;
  • what potential biases did the working group members have;
  • what is the basis for the IARC’s classificatory scheme; and
  • how are IARC’s key terms such as “sufficient,” “limited,” “probable,” “possible,” etc., defined and used by working groups.

Indeed, a very substantial trial could be had on the bona fides and methods of the IARC, and the glyphosate IARC working group in particular.

The curious irony behind the Valentine’s Day order is that plaintiffs’ counsel were generally winning their objections to the defense’s references to foreign regulatory determinations. But as pigs get fatter, hogs get slaughtered. Last year, plaintiffs’ counsel moved to “exclude foreign regulatory registrations and or approvals of glyphosate.”[12] To be sure, plaintiffs’ counsel were not seeking merely the exclusion of glyphosate registrations, but the scientific evaluations of regulatory agencies and their staff scientists and consulting scientists. Plaintiffs wanted trials in which juries would hear only about IARC, as though it was a scientific consensus. The many scientific regulatory considerations and rejections of the IARC evaluation would be purged from the courtroom.

On January 4, 2024, plaintiffs’ counsel obtained what they sought, an order that memorialized the tilted playing field they had largely been enjoying in Philadelphia courtrooms. Judge Roberts’ order was short and somewhat ambiguous:

“upon consideration of plaintiff’s motion in limine no. 5 to exclude foreign regulatory registrations and/or approvals of glyphosate, GBHs, and/or Roundup, any response thereto, the supplements of the parties, and oral argument, it is ORDERED that the motion is GRANTED without prejudice to a party’s introduction of foreign scientific evidence including, but not limited to, evidence from the International Agency for Research on Cancer (IARC), provided that such introduction does not refer to foreign regulatory agencies.”

The courtroom “real world” outcome after Judge Roberts’ order was an obscene verdict in the McKivison case. Again, there may have been many contributing causes to the McKivison verdict, including Pennsylvania’s murky and retrograde law of expert witness opinion testimony.[13] Mr. McKivison was in remission from NHL and had sustained no economic damages, and yet, on January 26, 2024, a jury in his case returned a punitive compensatory damages award of $250 million, and an even more punitive punitive damage award of $2 billion.[14] It seems at least plausible that the imbalance between admitting the IARC evaluation while excluding foreign regulatory assessments helped create a false narrative that scientists and regulators everywhere had determined glyphosate to be unsafe.

On February 2, 2024, the defense moved for a clarification of Judge Roberts’ January 4, 2024 order that applied globally in the Philadelphia glyphosate litigation. The defendants complained that in their previous trial, after Judge Roberts’ Order of January 4, 2024, they were severely prejudiced by being prohibited from referring to the conclusions and assessments of foreign scientists who worked for regulatory agencies. The complaint seems well founded.  If a hearsay evaluation of glyphosate by an IARC working group is relevant and admissible, the conclusions of foreign scientists about glyphosate are relevant and admissible, whether or not they are employed by foreign regulatory agencies. Indeed, plaintiffs’ counsel routinely complained about Monsanto/Bayer’s “influence” over the United States Environmental Protection Agency, but the suggestion that the European Union’s regulators are in the pockets of Bayer is pretty farfetched. Indeed, the complaint about bias is peculiar coming from plaintifs’ counsel, who command an out-sized influence within the Collegium Ramazzini,[15] which in turn often dominates IARC working groups. Every agency and scientific group, including the IARC, has its “method,” its classificatory schemes, its definitions, and the like. By privileging the IARC conclusion, while excluding all the other many agencies and groups, and allowing plaintiffs’ counsel to argue that there is no real-world debate over glyphosate, Philadelphia courts play a malignant role in helping to generate the huge verdicts seen in glyphosate litigation.

The defense motion for clarification also stressed that the issue whether glyphosate causes NHL or other human cancer is not the probandum for which foreign agency and scientific group statements are relevant.  Pennsylvania has a most peculiar, idiosyncratic law of strict liability, under which such statements may not be relevant to liability questions. Plaintiffs’ counsel, in glyphosate and most tort litigations, however, routinely assert negligence as well as punitive damages claims. Allowing plaintiffs’ counsel to create a false and fraudulent narrative that Monsanto has flouted the consensus of the entire scientific and regulatory community in failing to label Roundup with cancer warnings is a travesty of the rule of law.

What seems clever by halves in the plaintiffs’ litigation approach was that its complaints about foreign regulatory assessments applied equally, if not more so, to the IARC glyphosate hazard evaluation. The glyphosate litigation is not likely as interminable as π, but it is irrational.

*      *     *      *      *     * 

Post Script.  Ten days after the verdict in Kline, and one day after the above post, the Philadelphia Inquirer released a story about the defense verdict. See Nick Vadala, “Monsanto wins first Roundup court case in recent string of Philadelphia lawsuits,” Phila. Inq. (Mar. 15, 2024).


[1] Bill 246, Indiana House of Representatives (1897); Petr Beckmann, A History of π at 174 (1971).

[2] See Robert Moran, “Philadelphia jury awards $175 million after deciding 83-year-old man got cancer from Roundup weed killer,” Phila. Inq. (Oct. 27, 2023); Nick Vadala, “Philadelphia jury awards $2.25 billion to man who claimed Roundup weed killer gave him cancer,” Phila. Inq. (Jan. 29, 2024).

[3] Phila. Ct. C.P. 2022-01641.

[4] George Woolston, “Monsanto Nabs 1st Win In Philly’s Roundup Trial Blitz,” Law360 (Mar. 5, 2024); Nicholas Malfitano, “After three initial losses, Roundup manufacturers get their first win in Philly courtroom,” Pennsylvania Record (Mar. 6, 2024).

[5][5] See David Hackett Fischer, “ Fallacies of Semantical Distortion,” chap. 10, in Historians’ Fallacies: Toward a Logic of Historical Thought (1970); see alsoIARC’s Fundamental Distinction Between Hazard and Risk – Lost in the Flood” (Feb. 1, 2024); “The IARC-hy of Evidence – Incoherent & Inconsistent Classification of Carcinogencity” (Sept. 19, 2023).

[6] Malfitano, note 2 (quoting Pinto); see also Law360, note 2 (quoting Pinto).

[7] Harry Frankfurt, On Bullshit at 63 (2005); seeThe Philosophy of Bad Expert Witness Opinion Testimony” (Oct. 2, 2010).

[8] See Malifanto, note 2 (quoting Pinto).

[9] In re Roundup Prods. Litig., Phila. Cty. Ct. C.P., May Term 2022-0550, Control No. 24020394 (Feb. 14, 2024) (Roberts, J.). In a footnote, the court explained that “an expert may testify that foreign scientists have concluded that Roundup and· glyphosate can be used safely and they do not cause cancer. In the example provided, there is no specific reference to an agency or regulatory body, and the jury is free to make a credibility determination based on the totality of the expert’s testimony. It is, however, impossible for this Court, in a pre-trial posture, to anticipate every iteration of a question asked or answer provided; it remains within the discretion of the trial judge to determine whether a question or answer is appropriate based on the context and the trial circumstances.”

[10] See National Ass’n of Wheat Growers v. Bonta, 85 F.4th 1263, 1270 (9th Cir. 2023) (“A significant number of . . . organizations disagree with IARC’s conclusion that glyphosate is a probable carcinogen”; … “[g]lobal studies from the European Union, Canada, Australia, New Zealand, Japan, and South Korea have all concluded that glyphosate is unlikely to be carcinogenic to humans.”).

[11] See, e.g., In re Seroquel, 601 F. Supp. 2d 1313, 1318 (M.D. Fla. 2009) (noting that references to foreign regulatory actions or decisions “without providing context concerning the regulatory schemes and decision-making processes involved would strip the jury of any framework within which to evaluate the meaning of that evidence”)

[12] McKivison v. Monsanto Co., Phila. Cty. Ct. C.P., No. 2022- 00337, Plaintiff’s Motion in Limine No. 5 to Exclude Foreign Regulatory Registration and/or Approvals of Glyphosate, GHBs and/or Roundup.

[13] See Sherman Joyce, “New Rule 702 Helps Judges Keep Bad Science Out Of Court,” Law360 (Feb. 13, 2024) (noting Pennsylvania’s outlier status on evidence law that enables dodgy opinion testimony).

[14] P.J. D’Annunzio, “Monsanto Fights $2.25B Verdict After Philly Roundup Trial,” Law360 (Feb. 8, 2024).

[15]Collegium Ramazzini & Its Fellows – The Lobby” (Nov. 19, 2023).

Purging Compurgation

March 12th, 2024

“You could file briefs on a napkin right now and get it granted.”

Alan Lange & Tom Dawson, Kings of Torts 87 (2d ed. 2010) (quoting convicted former lawyer, Zach Scruggs)

Back in the 1980s, I started to see expert witnesses stray into the business of psychoanalysis of corporate defendants. Perhaps it took place earlier; it seemed to be a tactic when I first started to try cases. Not only did expert witnesses wish to indict products as causes of plaintiffs’ harms, they wanted to indict the motives and intentions of the manufacturers. Such “motive” testimony should have been cleared from courtrooms by the basic rule of expert witness opinion testimony; namely, the warrant for expert witness testimony is that the subject matter is “beyond the ken” of the jury. Given that the tendentious witnesses had no special skills in divining motives, and that jurors were routinely called upon to infer motives, the offending testimony should have been readily quashed. Almost 100 years ago, Judge Learned Hand, confronted with similar argumentative opinion testimony, held, in his magisterial way, that “[a]rgument is argument whether in the box or at the bar, and its proper place is the last.”[1]

What I found when I started trying cases was that many states had hard rules on expert witnesses, but soft judges. In some litigations, plaintiffs’ counsel offered a witness, such as the late Marc Lappé, not only to assess motives, but also to make ethical pronouncements about defendants’ conduct. More typically, the ethical judgments came from historian witnesses or regulatory expert witnesses. Occasionally, expert witnesses on health effects issues offered psychoanalytic opinions as well. Plaintiffs’ counsel typically argued that Federal Rule of Evidence 704, which declared that “[a]n opinion is not objectionable just because it embraces an ultimate issue,” green lighted their witnesses’ amateur or professional psychoanalysis. Defendants typically argued that the common law requirement that opinions be “beyond the ken” of jurors was carried forward in Rule 702’s requirement of relevant expertise, knowledge, and helpfulness to the trier of fact.  State court analogues to these rules replicated the debate in state courts around the country.

The attempt to deprecate the intentions or motives of a party were not necessarily enhanced when the expert witness compurgator had some semblance of subject-matter expertise. In one case, a frequent statistician testifier for the lawsuit industry, Martin Wells, expressed the opinion that the study at issue in the litigation “was seriously flawed by bad epidemiological practice. The combination of bias and poor epidemiologic practice is so rampant that one can easily conclude the study was intentionally designed to achieve a desired result regardless of the actual findings in the data.”[2]

Wells may have been entitled to his opinion about the quality of the study at issue, and if he had good grounds and a reliable methodology, perhaps he should have been permitted to share that opinion with a jury. The court, however, held that opinions based upon “inferences about the intent or motive of parties … lie outside the bounds of expert testimony, but are instead classic jury questions.”[3] The acceptability of the Wells’ compurgation was not improved or made more admissible by coating it with a patina of expertise about interpreting studies. The trial court found that:

“Dr. Wells’ statements represent his subjective beliefs regarding an alleged bad motive or intent on the part of defendants or others who designed the study. The Court finds that his speculation about the reason for alleged methodological issues in the study are not the product of reliable methods, and will be excluded.”[4]

By 2011, or so, the case law interpreting common law and statutory rules about ethics and motive opinion generally tilted in favor of the defense.[5] Courts routinely excluded expert witness opinions about corporate knowledge, motivations, and intent, as irrelevant and inadmissible under Rule 702.

As though ethicist and historian testimony were not bad enough, imagine an economist offering testimony to deprecate lobbying efforts that are protected first amendment speech. In one multi-district litigation, thinking that they could get away with most anything, plaintiffs’ counsel offered just such an expert witness.

The expert witness at issue was an economist, Glen W. Harrison, of no particular distinction, who sought to serve as a compurgator in litigation. Harrison is an accomplished litigation witness, who was developed and trained by the Motley Rice firm and others in many tobacco cases.[6] What is clear is that he was deployed, in MDL 1535, to lobby the fact-finder inappropriately, without any real expertise in the material science, toxicology, or epidemiology issues in the litigation.

The essence of Glen Harrison’s opinion is that the “manufacturing industry” saw itself as having an “economic incentive” to engage in lobbying. This opinion was either tautologically or trivially true, but plaintiffs sought the opportunity to cast lawful (and constitutionally protected) lobbying as nefarious and tortious. A disinterested observer might have thought that the important issue was whether the lobbying was unlawful and thus inappropriate, but Harrison was not an expert on the law governing stakeholders’ submissions to agencies or to organizations that promulgate standards.

Harrison’s opinion on “inappropriateness” was based upon his inexpert factual review of documents, with occasional inferences or comments about whether the documents were incomplete, or inconsistent with other pieces of evidence. What was remarkable about this bold attempt to subvert the MDL trial process was that Harrison had absolutely no expertise or competence to discuss documents that involved issues of epidemiology, risk assessment, neurology, neuropsychology, toxicology, or exposure measurements. Harrison tried to squeeze out some bare relevance by commenting upon documents with his personal, lay observations that they seemed inaccurate, or that they were incomplete. Of course, a lawyer could equally well argue the point to the jury in summation. Clearly, the goal of proffering Harrison was to have a summation from a witness, with a pleasant Australian accent, in the middle of the plaintiffs’ case in chief. If you listened closely, you could hear a roar of disapproval from the Albany Rural Cemetery.[7]

For some time, the MDL 1535 judge winked at the plaintiffs’ and Harrison’s improper ploy to demonize lawful, appropriate industry conduct, and the MDL resolved before the parties obtained a ruling on Harrison’s proffered testimony. While the issue was before the MDL court, it appeared unmoved by considerations of the First Amendment or of the Noerr-Pennington doctrine,[8] or even the statutory invitation and right to comment upon proposed regulations.[9] Of course, manufacturing and lawsuit industries have a right to participate in notice and comment periods of rulemaking. The courtroom asymmetry threatened by Harrison’s proffered testimony was that plaintiffs’ counsel could comment upon defendants’ lobbying, but defense counsel had no equivalent opportunity to comment upon the lawsuit’s extensive rent seeking.[10]


[1] Nichols v. Universal Pictures Corp., 45 F.2d 119, 123 (2d Cir. 1930) (Hand, J.).

[2] In re Trasylol Prods. Liab. Litig., 08-md-01928, 2010 WL 1489793, at *2 (S.D. Fla. Feb. 24, 2010) (quoting from Rule 26 report of Martin T. Wells ¶ 4, Van Steenburgh Affidavit, Exhibit B, Docket No. 1677).

[3] Id. at *8 (internal quotation marks omitted).

[4] Id. at *2.

[5] See Beck, “Experts Offering Evidence of Corporate Intent, Ethics, And The Like,” Drug & Device Law (May 19, 2011) (collecting cases). See, e.g., Kidder, Peabody & Co., Inc. v. IAG Int’l Acceptance Grp., N.V., 14 F.Supp. 2d 391, 404 (S.D.N.Y.1998); Crown Cork, 2013 WL 978980, at *7 (excluding expert opinions of parties’ knowledge, state of mind, and intent); DePaepe v. General Motors Corp., 141 F.3d 714, 720 (7th Cir. 1998) (disallowing opinion of expert witness, who “lacked any scientific basis for an opinion about … motives,” about defendant’s failure to add safety measure in order to “save money”); In re Diet Drugs Prods. Liab. Litig., 2000 WL 876900, at *9 (E.D.Pa. June 20, 2000) (noting that “question of intent is a classic jury question and not one for experts”); Smith v. Wyeth-Ayerst Laboratories Co., 278 F.Supp.2d 684, 700 (W.D.N.C. 2003) (expert witnesses may not opine about corporate intent and motive) (barring Dr. Moye from giving such testimony); In re Rezulin Products Liab. Litig., 309 F. Supp. 2d 531, 543, 545 n.37 (S.D.N.Y.2004) (excluding opinions on intent and motive, as well as historical narrative gleaned form otherwise admissible documentary evidence); In re Baycol Prods. Liab. Litig., 495 F. Supp. 2d 977, 1001 (D.Minn. 2007) (holding expert witness to have exceeded proper proffer “to the extent that he speculates as to Bayer’s motive, intent, or state of mind”); 532 F. Supp. 2d 1029, 1069 (D. Minn. 2007) (“[A]n expert may not testify as to ethical issues or to his personal views”; “[t]he question of corporate intent is one for the jury, not for an expert”); Reece v. Astrazeneca Pharms., LP, 500 F. Supp. 2d 736, 744-46 (S.D. Ohio 2007) (advisability of tests; warnings needed for particular medical conditions; lack of methodology); In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., 2007 WL 1964337, at *8 (D. Minn. June 29, 2007); Singh v. Edwards Lifesciences Corp., 2008 WL 5758387, ¶ELS 6 (Wash. Super. Snohomish Cty. Jan. 31, 2008); In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 192 (S.D.N.Y. 2009) (granting defendant’s motion to exclude testimony from Dr. Furberg about purported general ethical standards for conducting clinical trials); In re Xerox Corp. Sec. Litig., 746 F. Supp. 2d 402, 415 (D. Conn. 2010) (“Inferences about the intent or motive of parties or others lie outside the bounds of expert testimony.”) (internal citations omitted); In re Gadolinium-Based Contrast Agents Prods. Liab. Litig., 2010 WL 1796334, at *13 (N.D. Ohio May 4, 2010); In re Levaquin Prods. Liab. Litig., 2010 WL 11470977 (D. Minn. Nov. 10, 2010); Deutsch v. Novartis Pharms. Corp., 768 F. Supp.2d 420, 467 (E.D.N.Y. 2011); In re Heparin Prods. Liab. Litig., 2011 WL 1059660, at *8 (N.D. Ohio March 21, 2011); Lemons v. Novartis Pharms. Corp., 849 F. Supp.2d 608, 615 (W.D.N.C. 2012); Hill v. Novartis Pharms. Corp., 2012 WL 5451809, at *2 (E.D. Cal. Nov. 7, 2012); Georges v. Novartis Pharms. Corp., 2012 WL 9064768, at *13 (C.D. Cal. Nov. 2, 2012); Johnson v. Wyeth LLC, 2012 WL 1204081, at *3 (D. Ariz. Apr. 11, 2012); Pritchett v. I-Flow Corp., 2012 WL 1059948, at *6 (D. Colo. Mar. 28, 2012); Chandler v. Greenstone Ltd., 2012 WL 882756, at *1 (W.D. Wash. Mar. 14, 2012); Winter v. Novartis Pharms. Corp., 2012 WL 827305, at *5 (W.D. Mo. March 8, 2012); Earp v. Novartis Pharms. Corp., 2013 WL 4854488, at *4 (E.D.N.C. Sept. 11, 2013).

[6] See, e.g., Group Health Plan, Inc. v. Philip Morris, Inc., 188 F. Supp. 2d 1122 (D. Minn. 2002); Blue Cross & Blue Shield of N.J. v. Philip Morris, 178 F. Supp. 2d 198 (E.D.N.Y. 2001); Rent-A-Center West Inc.  v. Dept. of Revenue, 418 S.C. 320, 792 S.E.2d 260 (2016).

[7] Where Judge Learned Hand was buried.

[8] See, e.g., Video Int’l Prod., Inc. v. Warner-Amex Cable Comm., Inc., 858 F.2d 1075, 1084 (5th Cir. 1988) (applying Noerr-Pennington doctrine to bar use of evidence of lobbying in tort case); Hamilton v. AccuTek, 935 F. Supp. 1307, 1321 (E.D.N.Y. 1996) (granting summary judgment to gun makers on product liability and fraud claims based upon their efforts to influence federal policies by lawful lobbying); In re Municipal Stormwater Pond, No. 18-cv-3495 (JNE/KMM), 2019 U.S. Dist. LEXIS 227887, at *12 (D. Minn. Dec. 20, 2019) (dismissing claims of fraudulent misrepresentation claims against maker of coal-tar sealant on grounds that the Noerr-Pennington doctrine protected manufacturer’s lobbying before state and local governments); Eiser v. Brown & Williamson Tobacco Corp., Phila. Ct. Com. Pleas LEXIS 43, *20, 2005 WL 1323030 (2005) (invoking Noerr-Pennington doctrine to bar evidence of defendant manufacturer’s lobbying in products liability case). See generally James M. Sabovich, “Petition without Exception: Against the Fraud Exception to Noerr-Pennington Immunity from the Toxic Tort Perspective,” 17 Penn State Envt’l L. Rev. 101 (2008).

[9] See Admin. Procedures Act, 5 U.S.C. § 553; Attorney General’s Manual on the Administrative Procedure Act 31 (1947) (“[t]he objective should be to assure informed administrative action and adequate protection to private interests”).

[10] Lawsuit industry certainly exercises its rent-seeking through legitimate lobbying, and occasionally through illegimate means.  See U.S. v. Scruggs, 691 F.3d 660 (5th Cir. 2012).

A Citation for Jurs & DeVito’s Unlawful U-Turn

February 27th, 2024

Antic proposals abound in the legal analysis of expert witness opinion evidence. In the courtroom, the standards for admitting or excluding such evidence are found in judicial decisions or in statutes. When legislatures have specified standards for admitting expert witness opinions, courts have a duty to apply the standards to the facts before them. Law professors are, of course, untethered from either precedent or statute, and so we may expect chaos to ensue when they wade into disputes about the proper scope of expert witness gatekeeping.

Andrew Jurs teaches about science and the law at the Drake University Law School, and Scott DeVito is an associate professor of law at the Jacksonville University School of Law. Together, they have recently produced one of the most antic of antic proposals in a fatuous call for the wholesale revision of the law of expert witnesses.[1]

Jurs and DeVito rightly point out that since the Supreme Court, in Daubert,[2] waded into the dispute whether the historical Frye decision survived the enactment of the Federal Rules of Evidence, we have seen lower courts apply the legal standard inconsistently and sometimes incoherently. These authors, however, like many other academics, incorrectly label one or the other standard, Frye or Daubert, as being stricter than the other. Applying the labels of stricter and weaker standards, ignores that they are standards that measure completely different things. Frye advances a sociological standard, and a Frye test challenge can be answered by conducting a survey. Rule 702, as interpreted by Daubert, and as since revised and adopted by the Supreme Court and Congress, is an epistemic standard. Jurs and DeVito, like many other legal academic writers, apply a single adjective to standards that measure two different, incommensurate things. The authors’ repetition of the now 30-plus year-old mistake is a poor start for a law review article that sets out to reform the widespread inconsistency in the application of Rule 702, in federal and in state courts.

In seeking greater adherence to the actual rule, and consistency among decisions, Jurs and DeVito might have urged for judicial education, or blue-ribbon juries, or science courts, or greater use of court-appointed expert witnesses. Instead they have put their marker down on abandoning all meaningful gatekeeping. Jurs and DeVito are intent upon repairing the inconsistency and incoherency in the application of Daubert, by removing the standard altogether.

“To resolve the problem, we propose that the Courts replace the multiple Daubert factors with a single factor—testability—and that once the evidence meets this standard the judge should provide the jury with a proposed jury instruction to guide their analysis of the fact question addressed by the expert evidence.”[3]

In other words, because lower federal courts have routinely ignored the actual statutory language of Rule 702, and Supreme Court precedents, Jurs and DeVito would have courts invent a new standard, that virtually excludes nothing as long as someone can imagine a test for the asserted opinion. Remarkably, although they carry on about the “rule of law,” the authors fail to mention that judges have no authority to ignore the requirements of Rule 702. And perhaps even more stunning is that they have advanced their nihilistic proposal in the face of the remedial changes in Rule 702, designed to address judicial lawlessness in ignoring previously enacted versions of Rule 702. This antic proposal would bootstrap previous judicial “flyblowing” of a Congressional mandate into a prescription for abandoning any meaningful standard. They have articulated the Cole Porter standard: anything goes. Any opinion that “can be tested is science”; end of discussion.  The rest is for the jury to decide as a question of fact, subject to the fact finder’s credibility determinations. This would be a Scott v. Sandford rule[4] for scientific validity; science has no claims of validity that the law is bound to respect.

Jurs and DeVito attempt a cynical trick. They argue that they would fix the problem of “an unpredictable standard” by reverting to what they say is Daubert’s first principle of ensuring the reliability of expert witness testimony, and limiting the evidentiary display at trial to “good science.” Cloaking their nihilism, the authors say that they want to promote “good science,” but advocate the admissibility of any and every opinion, as long as it is theoretically “testable.” In order to achieve this befuddled goal, they simply redefine scientific knowledge as “essentially” equal to testable propositions.[5]

Jurs and DeVito marshal evidence of judicial ignorance of key aspects of scientific method, such as error rate. We can all agree that judges frequently misunderstand key scientific concepts, but their misunderstandings and misapplications do not mean that the concepts are unimportant or unnecessary. Many judges seem unable to deliver an opinion that correctly defines p-value or confidence interval, but their inabilities do not allow us to dispense with the need to assess random error in statistical tests. Our faint-hearted authors never explain why the prevalence of judicial error must be a counsel of despair that drives us to bowdlerize scientific evidence into something it is not. We may simply need better training for judges, or better assistance for them in addressing complex claims. Ultimately, we need better judges.

For those judges who have taken their responsibility seriously, and who have engaged with the complexities of evaluating validity concerns raised in Rule 702 and 703 challenges, the Jurs and DeVito proposal must seem quite patronizing. The “Daubert” factors are simply too complex for you, so we will just give you crayons, or a single, meaningless factor that you cannot screw up.[6]

The authors set out a breezy, selective review of statements by a few scientists and philosophers of science. Rather than supporting the extreme reductionism, Jurs and DeVito’s review reveals that science is much more than identifying a “testable” proposition. Indeed, the article’s discussion of philosophy and practice of science weighs strongly against the authors’ addled proposal.[7]

The authors, for example, note that Sir Isaac Newton emphasized the importance of empirical method.[8] Contrary to the article’s radical reductionism, the authors note that Sir Karl Popper and Albert Einstein stressed that the failure to obtain a predicted experimental result may render a theory “untenable,” which of course requires data and valid tests and inferences to assess. Quite a bit of motivated reasoning has led Jurs and DeVito to confuse a criterion of testability with the whole enterprise of science, and to ignore the various criteria of validity for collecting data, testing hypotheses, and interpreting results.

The authors suggest that their proposal will limit the judicial inquiry to the the legal question of reliability, but this suggestion is mere farce. Reliability means obtaining the same or sufficiently similar results upon repeated testing, but these authors abjure testing itself.  Furthermore, reliability as contemplated by the Supreme Court, in 1993, and by FRE 702 ever since, has meant validity of the actual test that an expert witness argues in support of his or her opinion or claims.

Whimsically, and without evidence, Jurs and DeVito claim that their radical abandonment of gatekeeping will encourage scientists, in “fields that are testable, but not yet tested, to perform real, objective, and detailed research.” Their proposal, however, works to remove any such incentive because untested but testable research becomes freely admissible. Why would the lawsuit industry fund studies, which might not support their litigation claims, when the industry’s witnesses need only imagine a possible test to advance their claims, without the potential embarrassment by facts? The history of modern tort law teaches us that cheap speculation would quickly push out actual scientific studies.

The authors’ proposal would simply open the floodgates of speculation, conjecture, and untested hypothesis, and leave the rest to the vagaries of trials, mostly in front of jurors untrained in evaluating scientific and statistical evidence. Admittedly, some incurious and incompetent gatekeepers and triers of fact will be relieved to know that they will not have to evaluate actual scientific evidence, because it had been eliminated by the Jurs and DeVito proposal to make mere testability the touchstone of admissibility

To be sure, in Aristotelian terms, testability is logical and practically prior to testing, but these relationships do not justify holding out testability as the “essence” of science, and the alpha and omega of science.[9] Of course, one must have an hypothesis to engage in hypothesis testing, but science lies in the clever interrogation of nature, guided by the hypothesis. The scientific process lies in answering the question, not simply in formulating the question.

As for the authors’ professed concern about “rule of law,” readers should note that the Jurs and DeVito article completely ignores the remedial amendment to Rule 702, which went into effect on December 1, 2023, to address the myriad inconsistencies, and failures to engage, in required gatekeeping of expert witness opinion testimony.[10]

The new Rule 702 is now law, with its remedial clarification that the proponent of expert witness opinion must show the court that the opinion is sufficiently supported by facts or data, Rule 702(b), and that the opinion “reflects a reliable application of the principles and methods to the facts of the case,” Rule 702(d). The Rule prohibits deferring the evaluation of sufficiency of support or reliability of application of method to the trier of fact; there is no statutory support for suggesting that these inquires always or usually go to “weight and not admissibility.”

The Jurs and DeVito proposal would indeed be a U-Turn in the law of expert witness opinion testimony. Rather than promote the rule of law, they have issued an open, transparent call for licentiousness in the adjudication of scientific and technical issues.


[1] Andrew Jurs & Scott DeVito, “A Return to Rationality: Restoring the Rule of Law After Daubert’s Disasterous U-Turn,” 164 New Mexico L. Rev. 164 (2024) [cited below as U-Turn]

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

[3] U-Turn at 164, Abstract.

[4] 60 U.S. 393 (1857).

[5] U-Turn at 167.

[6] U-Turn at 192.

[7] See, e.g., U-Turn at 193 n.179, citing David C. Gooding, “Experiment,” in W.H. Newton-Smith, ed., A Companion to the Philosophy of Science 117 (2000) (emphasizing the role of actual experimentation, not the possibility of experimentation, in the development of science).

[8] U-Turn at 194.

[9] See U-Turn at 196.

[10] See Supreme Court Order, at 3 (Apr. 24, 2023); Supreme Court Transmittal Package (Apr. 24, 2023).

Grumpy Old Men

February 11th, 2024

This blog is not about politics, although sometimes I have wandered into the political thicket when the events of the day involved scientific and statistical issues.[1] Our current events today do not involve statistical evidence so much as political, moral, and practical judgment. At some point, however, I cannot avoid a sense of responsibility to speak on the issues. On the one side, we have a grumpy old man who has evidenced some senior moments. On the other side, we have a grumpy old man who has evidenced senior moments as well as a vile character and temperament, generally devoid of decency, historical knowledge, and practical judgment.

Some have argued that the first grumpy old man is propped up by Marxists, the ultra-woke, and “haters” of the USA. Others have argued that the second grumpy old man is a creature of a personality cult, and that he is a documented rapist, fraudster, liar, hustler, and worse.[2]

Well, I know I am not going to firm up the political quagmire on which we now stand. But I have a humble, and I hope constructive, suggestion. Supporters of both grumpy old men would, I think, agree that they care about strength, intelligence, tactical and strategic ability, mental acuity and stamina, and a desire to win.  My suggestion is instead of having debates between the main protagonists, which many would agree to be a waste of time and money, we should instead require the grumpy old men to face off in a chess match. It need not be long; it could be, say, best of three games. Their moves would be observable by all, including their ability to conform to the rules of game, which require, among other things, refraining from talking and making noise. The American public, and the world, would see whether one or the other, or both, or neither, of the grumpy old men have the cognitive and intellectual ability and a true “killer” instinct, to be a national leader in these troubled times. Professional psychologists could analyze the intelligence of the players in real time.

Perhaps the rules of the game might be modified to include shock collars to discipline either player who spoke during the game, other than to offer a draw, or to resign.

Perhaps I am grumpy old man myself.


[1] SeePernicious Probabilities in the Supreme Court” (Nov. 21, 2020); “A Trumpence for Your Thoughts” (Nov. 21, 2020). And I have supported sound deployment of statistical evidence. See, e.g., Brief of 27 Election Law, Scientific Evidence, and Empirical Legal Scholars as Amici Curiae in Support of Appellees, in Rucho v. Common Cause, No. 18-422, Supreme Court of the United States (Mar. 9, 2019); Brief of 44 Election Law, Scientific Evidence, and Empirical Legal Scholars as Amici Curiae in Support of Appellees, in Gill v. Whitford, No. 16-1161, Supreme Court of the United States (Sept. 1, 2017).

[2] The supporters of the second grumpy old man have criticized those who criticize his supporters, on grounds that there are substantive issues at stake in their support.  See Julian Adorney, “Stop Dunking on Trump Supporters: No one is beyond reach—unless everyone around them refuses to reach out,” Quilette (Feb. 7, 2024). This of course misses the point that the supporters have had plenty of other viable candidates to support who would have actually been articulate voices on their behalf.  The supporters have shown, consistently over eight years, that they do not care about immorality or sycophancy to dictators, and that they prefer a sexual abuser and fraudster.

IARC’S Fundamental Distinction Between Hazard and Risk – Lost in the Flood

February 1st, 2024

Socrates viewed philosophy as beginning in wonder,[1] but Socrates and his philosophic heirs recognized that philosophy does not get down to business until it starts to clarify the terms of discussion. By the middle of the last century, failure to understand the logic of language replaced wonder as the beginning of philosophy.[2] Even if philosophy could not cure all conceptual pathology, most writers came to see that clarifying terms, concepts, and usage was an essential starting point in thinking clearly about a subject.[3]

Hazard versus Risk

Precision in scientific exposition often follows from the use of measurements, using agreed upon quantitative units, and accepted, accurate, reliable procedures for measurements. When scientists substitute qualitative measures for what are inherently quantitative measures, they frequently lapse into error. For example, beware of rodent studies that proclaim harms at “low doses,” which turn out to low in comparison to other rodent studies, but orders of magnitude greater exposure than experienced by human beings.

Risk is a quantitative term meaning a rate of some specified outcome. A Dictionary of Epidemiology, for instance, defines risk as:

“The probability of an adverse or beneficial event in a defined population over a specified time interval. In epidemiology and in clinical research it is commonly measured through the cumulative incidence and the incidence proportion.”[4]

An increased risk thus requires a measurement of a rate or probability of an outcome greater than expected in the absence of the exposure of interest. We might be uncertain of the precise measure of the risk, or of an increased risk, but conceptually a risk connotes a rate or a probability that is, at least in theory, measurable.

Hazard is a categorical concept; something is, or is not, a hazard without regard to the rate or incidence of harm. The definition of “hazard,” in the Dictionary of Epidemiology provides a definition that captures the non-quantitative, categorical natural of some exposure’s being a hazard:

“The inherent capability of a natural or human-made agent or process to adversely affect human life, health, property, or activity, with the potential to cause a disease.”[5]

The International Agency for Research on Cancer (IARC) purports to set out a classification scheme, for human cancer hazards. As used by IARC, its classification scheme involves a set of epistemic modal terms: “known,” “probably,” “possibly,” and “indeterminate.” These epistemic modalities characterize the strength of the evidence that an agent is carcinogenic, and not the magnitude of quantitative risk of cancer from exposure at a given level. The IARC Preamble, which attempts to describe the Agency’s methodology, explains that the distinction between hazard and risk is “fundamental”:

“A cancer hazard is an agent that is capable of causing cancer, whereas a cancer risk is an estimate of the probability that cancer will occur given some level of exposure to a cancer hazard. The Monographs assess the strength of evidence that an agent is a cancer hazard. The distinction between hazard and risk is fundamental. The Monographs identify cancer hazards even when risks appear to be low in some exposure scenarios. This is because the exposure may be widespread at low levels, and because exposure levels in many populations are not known or documented.”[6]

This attempted explanation reveals an important problem in IARC’s project, as stated in the Preamble. First, there is an unproven assumption that there will be cancer hazards regardless of the exposure levels. The IARC contemplates that there may circumstances of low levels of risk from low levels of exposure, but it elides the important issue of thresholds of exposure, below which there is no risk. The Preamble suggests that IARC does not attempt to provide evidence for or against meaningful thresholds of hazardousness, but this failure greatly undermines the project.  Exposure circumstances may be such that there is no hazard at all, and so the risk is zero.

The purported distinction between hazard and risk, supposedly fundamental, is often blurred by the Agency, in the monographs produced by working groups on specific exposure circumstances. Consider for instance how a working group characterized the “hazard” of inhalation of respirable crystalline silica:

“ln making the overalI evaluation, the Working Group noted that carcinogenicity in humans was not detected in all industrial circumstances studied. Carcinogenicity may be dependent on inherent characteristics of the crystalline silica or on external factors affecting its biological activity or distribution of its polymorphs.

Crystalline silica inhaled in the form of quartz or cristobalite from occupational sources is carcinogenic to humans (Group 1)”[7]

So some IARC classifications actually do specify that exposure to a substance is not a hazard in all circumstances, a qualification that implies that the same exposure in some exposure circumstances is not a hazard, and so the risk is zero.

We know something about the deliberations of the crystalline silica working group. The members were deadlocked for some time, and the switch of one vote ultimately gave a bare majority to reclassifying crystalline silica as a Group I exposure. Here is how the working group member, Corbett McDonald described the situation:

“The IARC Working Group, in 1997, had considerable difficulty in reaching a decision and might well not have done so had it not been made clear that it was concerned with hazard identification, not risk.”[8]

It was indeed Professor McDonald who changed his vote based upon this linguistic distinction between hazard and risk. His own description of the dataset, however, suggests that the elderly McDonald was railroaded by more younger, more strident members of the group:

“Of the many studies reviewed by the Working Group … nine were identified as providing the least confounded evidence. Four studies which we considered positive included two of refractory brick workers, one in the diatomite industry and our own in pottery workers; the five which seemed negative or equivocal included studies of South Dakota gold miners, Danish stone workers, US stone workers and US granite workers. This further example that the truth is seldom pure and never simple underlines the difficulty of establishing a rational control policy for some carcinogenic materials.”[9]

In defense of his vote, McDonald meekly offered that

“[s]ome equally expert panel of scientists presented with the same information on another occasion could of course have reached a different verdict. The evidence was conflicting and difficult to assess and such judgments are essentially subjective. Of course, when the evidence is conflicting, it cannot be said to be sufficient. Not only was the epidemiologic evidence conflicting, but so was the whole animal toxicology, which found a risk of tumors in rats, but not in mice or hamsters.”

Aside from endorsing a Group I classification for crystalline silica, the working group ignored the purportedly fundamental distinction between hazard and risk, by noting that not all exposure circumstances posed a hazard of cancer. The same working group did even greater violence to the supposed distinction between risk and hazard in its evaluation of coal dust exposure and human cancer. Coal miners have been studied extensively for cancer risk, and the working group reviewed and evaluated the nature of their exposures and their cancer outcomes. Coal dust virtually always contains crystalline silica, often making up a sizable percentage of the total inhalational exposures (40% or so) of coal dust.[10] And yet, when the group studied the cancer rates among coal miners, and in animals, it concluded that there was “inadequate evidence in humans, and “in experimental animals,” for carcinogenicity. The same working group that agreed, on a divided vote, to place crystalline silica in Group 1, voted that “[c]oal dust cannot be classified as to its carcinogenicity to humans (Group 3).”[11]

The conceptual confusion between hazard and risk is compounded by the IARC’s use of epistemic modalities – known, probably, possibly, and indeterminate – to characterize the existence of a hazard. The Preamble, in Table 4, summarizes the categories and “the stream of evidence” needed to place any particular exposure in a one epistemic modal class or another. What is inexplicable is how and why a single substance such as crystalline silica goes from a known cancer hazard in some unspecified occupational setting but then its putative carcinogenicity becomes indeterminate when it makes up 40% of the inhaled dust in a coal mine.

 

The conceptual difficulty created by IARC’s fundamental distinction between hazard and risk is that risk might well vary across exposure circumstances, but there is no basis for varying the epistemic modality for the hazard assessment simply because coal dust is only say 40% crystalline silica. Some of the exposure circumstances evaluated for the Group I silica hazard classification actually were lower than the silica content of coal.  Granite quarrying, for example, involves exposure to rock dust that is roughly 30% crystalline silica.

The conceptual and epistemic confusion caused by IARC’s treatment of the same substance in different exposure circumstances is hardly unique to its treatment of crystalline silica and coal dust. Benzene has long been classified as a Group I human carcinogen, for its ability to cause a specific form of leukemia.[12] Gasoline contains, on average, about one percent benzene, and so gasoline exposure inevitably involves benzene exposure. And yet, benzene exposure in the form of inhaling gasoline fumes is only a “possible” human carcinogen, Group 2B.[13]

Similarly, in 2018, the IARC classified the evidence for the human carcinogenicity of coffee as “indeterminate,” Group 3.[14] And yet every drop of coffee inevitably contains acrylamide, which is, according to IARC, a Group 2A “probable human carcinogen.”[15] Rent-seeking groups, such as the Council for Education and Research on Toxics (founded by Carl Cranor and Martyn Smith) have tried shamelessly to weaponize the IARC 2A classification for acrylaminde by claiming a bounty against coffee sellers such as Star-Bucks in California Proposition 65 litigation.[16]

Similarly confusing, IARC designates acetaldehyde on its own a “possible” human carcinogen, group 2B, even though acetaldehyde is invariably associated with the metabolism of ethyl alcohol, which itself is a Group I human carcinogen.[17] There may well be other instances of such confusions, and I would welcome examples from readers.

These disparate conclusions strain credulity, and undermine confidence that the hazard-risk distinction does any work at all. Hazard and risk do have different meanings, and I would not want to be viewed as anti-semantic. IARC’s use of the hazard-risk distinction, however, lends itself to the interpretation that hazard is simply risk without the quantification. This usage actually is worse than having no distinction at all, because it ignores the existence of thresholds below which exposure carries no risk, as well as ignoring different routes of exposure and exposure circumstances that carry no risk at all. The vague and unquantified categorical determination that a substance is a hazard allows fear mongers to substitute subjective, emotive, and unscientific judgments for scientific assessment of carcinogenicity under realistic conditions of use and exposure.


[1] Plato, Theaetetus 155d (Fowler transl. 1921).

[2] Ludwig Wittgenstein, Philosophical Investigations (1953).

[3] See, e.g., Richard M. Rorty, ed., The Linguistic Turn: Essays in Philosophical Method (1992); Nicholas Rescher, Concept Audits: A Philosophical Method (2016); Timothy Williamson, Philosophical Method: A Very Short Introduction 32 (2020) (discussing the need to clarify terms).

[4] Miquel Porta, Sander Greenland, Miguel Hernán, Isabel dos Santos Silva, John M. Last, and Andrea Burón, A Dictionary of Epidemiology 250 (6th ed. 2014).

[5] Id. at 128.

[6] IARC Monographs on the Identification of Carcinogenic Hazards to Humans – Preamble (2019) (emphasis added).

[7] IARC Monograph on the Evaluation of Carcinogenic Risks to Humans: Volume 68, Silica, Some Silicates, Coal Dust, and para-Aramid Fibrils 210-211 (1997).

[8] Corbett McDonald & Nicola Cherry, “Crystalline Silica and Lung Cancer: The Problem of Conflicting Evidence,” 8 Indoor Built Environment 121, 121 (1999).

[9] Id.

[10] IARC Monograph on the Evaluation of Carcinogenic Risks to Humans: Volume 68, Silica, Some Silicates, Coal Dust, and para-Aramid Fibrils 340 (1997).

[11] Id. at 393.

[12] IARC Monograph, Volume 120: Benzene (2018).

[13] IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Volume 45, Occupational Exposures in Petroleum Refining; Crude Oil and Major Petroleum Fuels 194 (1989).

[14] IARC Monograph No. 116, Drinking Coffee, Mate, and Very Hot Beverages (2018).

[15] IARC Monograph no. 60, Some Industrial Chemicals (1994).

[16] SeeCoffee with Cream, Sugar & a Dash of Acrylamide” (June 9, 2018); “The Council for Education and Research on Toxics” (July 9, 2013).

[17] IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 96 1278 (2010).

The Maestro and Mesothelioma – Wikipedia & False Claims

January 21st, 2024

The Maestro is a biographical film of the late Leonard Bernstein. The film, starring Bradley Cooper as Bernstein, had a limited release before streaming on Netflix. As a work of biography, the film is peculiar in its focus on Bernstein’s sexuality and filandering, while paying virtually no attention to his radical chic politics, or his engagement with teaching music appreciation.

In any event, the film sent me to Wikipedia to fact check some details of Bernstein’s life, and I was surprised to see that Wikipedia described Bernstein’s cause of death as involving mesothelioma:

“Bernstein announced his retirement from conducting on October 9, 1990.[174] He died five days later at the age of 72, in his New York apartment at The Dakota, of a heart attack brought on by mesothelioma.[175][2]”

Bernstein certainly did not have occupational exposure to amphibole asbestos, but he did smoke cigarettes, several packs a day, for decades. Mesothelioma seemed unlikely, unless perhaps he smoked Kent cigarettes in the 1950s, when they had crocidolite filters. As you can see from the above quote, the Wikipedia article cites two sources, a newspaper account and a book. Footnote number 2 is an obituary was written by Donal Henahan, and printed in the New York Times.[1] The Times reported that:

“Leonard Bernstein, one of the most prodigally talented and successful musicians in American history, died yesterday evening at his apartment at the Dakota on the Upper West Side of Manhattan. He was 72 years old.

*   *   *   *   *   *   *

Mr. Bernstein’s spokeswoman, Margaret Carson, said he died of a heart attack caused by progressive lung failure.”

There is no mention of mesothelioma in the Times article, and the citation provided does not support the assertion that mesothelioma was involved in the cause of Bernstein’s death. The obituary cited was published the day following Bernstein’s death the night before, which suggests that there was no information from an autopsy, which would have been important in ascertaining any tissue pathology for an accurate and complete cause of death. In 1990, the diagnosis of malignant mesothelioma was often uncertain, even with extensive tissue available post-mortem.

The other citation provided by the Wikipedia article was even less impressive. Footnote 175 pointed to a book of short articles on musicians, with an entry for Bernstein.[2] The book tells us that

“Bernstein is most remembered, perhaps, for his flamboyant conducting style. *** Leonard Bernstein died at his home from cardiac arrest brought on by mesothelioma.”

The blurb on Bernstein provides no support for the statement that cardiac arrest was brought on by mesothelioma, and the narrative struck me as odd in leaving out the progressive lung failure caused by non-malignant smoking-induced lung disease.

I set out to find what else may have been written about the causes of Bernstein’s death. I was surprised to find other references to mesothelioma, but all without any support. One online article seemed promising, but offered a glib conclusion without any source:

“Leonard Bernstein, a towering figure in American music, met his end on October 14, 1990, just five days after retiring from his illustrious career as a conductor. Found in his New York apartment, the cause of his death was a heart attack induced by mesothelioma, a consequence of a lifetime of smoking.”[3]

The lack of any foot- or end-notes disqualifies this source, and others, for establishing a diagnosis of mesothelioma. Other internet articles, inspired by the Cooper production of Maestro, made very similar statements, all without citing any source.[4] Some of the internet articles likely plagiarized others, but I was unable to find who first gave rise to the conclusion that Bernstein died of complications of “mesothelioma” caused by smoking.

Whence came the Wikipedia’s pronouncement that Bernstein died of, or with, mesothelioma? Two “mainstream” print newspapers provided some real information and insight. An article in the Washington Post elaborated on Bernstein’s final illness and the cause of his death:

“Leonard Bernstein, 72, a giant in the American musical community who was simultaneously one of this nation’s most respected and versatile composers and preeminent conductors, died yesterday at his Manhattan apartment. He died in the presence of his physician, who said the cause of death was sudden cardiac arrest caused by progressive lung failure.

On the advice of the doctor, Kevin M. Cahill, Bernstein had announced through a spokeswoman Tuesday that he would retire from conducting. Cahill said progressive emphysema complicated by a pleural tumor and a series of lung infections had left Bernstein too weak to continue working.”[5]

Ah a pleural tumor, but no report or representation that it was malignant mesothelioma.

The Los Angeles Times, with the benefit of an extra three hours to prepare its obituary for a west coast audience, provided similar, detailed information about Bernstein’s death:

“Bernstein, known and beloved by the world as ‘Lenny’, died at 6:15 p.m. in the presence of his son, Alexander, and physician, Kevin M. Cahill, who said the cause of death was complications of progressive lung failure. On Cahill’s advice, the conductor had announced Tuesday that he would retire. Cahill said progressive emphysema complicated by a pleural tumor and a series of lung infections had left Bernstein too weak to continue working.”[6]

Now a pleural tumor can be benign or malignant. And if the tumor were malignant, it may or may not be a primary tumor of the pleura. Metastatic lesions of the pleura, or in the lung parenchyma adjacent to the pleura are common enough that the physician’s statement about tumor of the pleura cannot be transformed into a conclusion about mesothelioma.[7]

Feeling good about having sorted a confusion, I thought I could add to the font of all knowledge, Wikipedia, by editing its unsupported statement about mesothelioma to “pleural tumor.” I made the edit, but within a few days, someone had changed the text back to mesothelioma, without adding any support. The strength of any statement is, of course, based entirely upon its support and the strength of its inferences. Wikipedia certainly can be a reasonable starting place to look for information, but it has no ability to support a claim, whether historical, scientific, or medical. Perhaps I should have added the citation to the Washington Post obituary when I made my edit. Still, it was clear that nothing in article’s footnotes supported the text, and someone felt justified in returning the mention of mesothelioma based upon two completely unsupportive sources. Not only is the Bernstein article in Wikipedia suspect, but there is actually an entry in Wikipedia for “Deaths from Mesothelioma,” which lists Bernstein as well. The article has but one sentence: “This is a list of individuals who have died as a result of mesothelioma, which is usually caused by exposure to asbestos.” And then follows a list of 67 persons, of varying degree of noteworthiness, who supposedly died of mesothelioma. I wonder how many of the entries are false.


[1] Donal  Henahan, “Leonard Bernstein, 72, Music’s Monarch, Dies,” New York Times (October 15, 1990).

[2] Scott Stanton, The Tombstone Tourist: Musicians at 29 (2003).

[3] Soumyadeep Ganguly, “Leonard Bernstein’s cause of death explored: How does Bradley Cooper Maestro end? Movie ending explored,” SK POP (modified Dec 25, 2023).

[4] See, e.g., Gargi Chatterjee, “How did Leonard Bernstein die?” pinkvilla (Dec 23, 2023).

[5] Bart Barnes, “Conductor Leonard Bernstein Dies at 72,” Wash. Post (Oct. 15, 1990) (emphasis added).

[6] Myrna Oliver, “Leonard Bernstein Dies; Conductor, Composer. Renaissance man of his art was 72. The longtime leader of the N.Y. Philharmonic carved a niche in history with ‘West Side Story’,” Los Angeles Times (Oct. 15, 1990) (emphasis added).

[7] See, e.g., Julie Desimpel, Filip M. Vanhoenacker, Laurens Carp, and Annemiek Snoeckx, “Tumor and tumorlike conditions of the pleura and juxtapleural region: review of imaging findings,” 12 Insights Imaging 97 (2021).

The Proper Study of Mankind

December 24th, 2023

“Know then thyself, presume not God to scan;

The proper study of Mankind is Man.”[1]

 

Kristen Ranges recently earned her law degree from the University of Miami School of Law, and her doctorate in Environmental Science and Policy, from the University of Miami Rosenstiel School of Marine, Atmospheric, and Earth Science. Ranges’ dissertation was titled Animals Aiding Justice: The Deepwater Horizon Oil Spill and Ensuing Neurobehavioral Impacts as a Case Study for Using Animal Models in Toxic Tort Litigation – A Dissertation.[2] At first blush, Ranges would seem to be a credible interlocutor in the never-ending dispute over the role of whole animal toxicology (and in vitro toxicology) in determining human causation in tort litigation. Her dissertation title is, however, as Martin Short would say, a bit of a tell. Zebrafish become sad when exposed to oil spills, as do we all.

Ranges recently published a spin-off of her dissertation as a law review article with one of her professors. “Vermin of Proof: Arguments for the Admissibility of Animal Model Studies as Proof of Causation in Toxic Tort Litigation.”[3] Arguments for; no arguments against. We can thus understand this is an advocacy piece, which is fair enough. The paper was not designed or titled to mislead anyone into thinking it would be a consideration of arguments for and against extrapolation from (non-human) animal studies to human beings. Perhaps you will think it churlish of me to point out that animal studies will rarely be admissible as evidence. They come into consideration in legal cases only through expert witnesses’ reliance upon them. So the issue is not whether animal studies are admissible, but rather whether expert witness opinion testimony that relies solely or excessively on animal studies for purposes of inferring causation is admissible under the relevant evidentiary rules. Talking about the admissibility of animal model studies signals, if nothing else, a serious lack of familiarity with the relevant evidentiary rules.

Ranges’ law review is clearly, and without subtlety, an advocacy piece. She argues:

“However, judges, scholars, and other legal professionals are skeptical of the use of animal studies because of scientific and legal concerns, which range from interspecies disparities to prejudice of juries. These concerns are either unfounded or exaggerated. Animal model studies can be both reliable and relevant in toxic tort cases. Given the Federal Rules of Evidence, case law relevant to scientific evidence, and one of the goals of tort law-justice-judges should more readily admit these types of studies as evidence to help plaintiffs meet the burden of proof in toxic tort litigation.”[4]

For those of you who labor in this vineyard, I would suggest you read Ranges’ article and judge for yourself. What I see is a serious lack of scientific evidence for her claims, and a serious misunderstanding of the relevant law. One might, for starters, putting aside the Agency’s epistemic dilution, ask whether there are any I.A.R.C. category I (“known”) carcinogens based solely upon animal evidence. Or has the U.S. Food & Drug Administration ever approved a medication as reasonably safe and effective based upon only animal studies?

Every dog owner and lover has likely been told by a veterinarian, or the Humane Society, that we should resist their lupine entreaties and withhold chocolate, raisins, walnuts, avocados, and certain other human foods. Despite their obvious intelligence, capacity for affection, when it comes to toxicology, dogs are not people, although some people act like the less reputable varieties of dogs.

Back in 1985, in connection with Agent Orange litigation, the late Judge Jack Weinstein wrote what was correct then, and even more so today, that “laboratory animal studies are generally viewed with more suspicion than epidemiological studies, because they require making the assumption that chemicals behave similarly in different species.”[5] Judge Weinstein was no push-over for strident defense counsel or expert witnesses, but the legal consequences were nonetheless obvious to him, when he looked carefully at the animal studies plaintiffs’ expert witnesses were claiming to support their opinions. “[A]nimal studies are of so little probative value as to be inadmissible.  They cannot be a predicate for an opinion under Rule 703.”[6] One of the several disconnects between the plaintiffs’ expert witnesses’ animal studies and the human diseases claimed was the disparity of dose and duration between the relied upon studies and the service men claimants. Judge Weinstein observed that when the hand waving stopped, “[t]here is no evidence that plaintiffs were exposed to the far higher concentrations involved in both animal and industrial exposure studies.”[7]

Ranges and Oakley unfairly deprecate the Supreme Court’s treatment of animal evidence in the 1997 Joiner opinion.[8] Mr. Joiner had been an electrician by a small city in Georgia, where he experienced dermal exposure, over several years, to polychlorinated biphenyls (PCB’s), a chemical found in electrical transformer coolant. He alleged that he had developed small-cell lung cancer from his occasional occupational exposure. In the district court, a careful judge excluded the plaintiffs’ expert witnesses, who relied heavily upon animal studies and who cherry picked and distorted the available epidemiology.[9] The Court of Appeals reversed, in an unsigned, non-substantive opinion that interjected an asymmetric standard of review.[10]

After granting review, the Supreme Court engaged with the substantive validity issues passed over by the intermediate appellate court. In addressing the plaintiff’s expert witnesses’s reliance upon animal studies, the Court was struck by an extrapolation from a different species, different route of administration, different dose, different duration of exposure, and different disease.[11] Joiner was an adult human whose alleged exposure to PCBs was far less than the exposure in the baby mice that received injections of PCBs in a high concentration. The mice developed alveologenic adenomas, a rare tumor that is usually benign, not malignant.[12] The Joiner Court recognized that these multiple extrapolations were a bridge to nowhere, and reversed the Court of Appeals, and reinstated the judgment of the district court. What is particular salient about the Joiner decision, and about which you will find no discussion in the law review paper by Ranges and Oakley, is how well the Joiner opinion has held up over quarter of a century that passed. Today, in the waning moments of 2023, there is still no valid, scientifically sound support for the claim that the sort of exposure Mr. Joiner had can cause small-cell lung cancer.[13]

Perhaps the most egregious lapses in scholarship occur when Ranges, a newly minted scientist, and her co-author, a full professor of law, write:

“For example, Bendectin, an antinausea medication prescribed to pregnant women, caused a slew of birth defects (hence its nickname ‘The Second Thalidomide’).49[14]

I had to re-read this sentence many times to make sure I was not hallucinating. Ranges’ and Oakley’s statement is, of course, demonstrably false. A double whooper, at least, and a jarring deviation from the standard of scholarly care.

But their statement is footnoted you say. Here is what the cited article, footnote 40 in “Vermin of Proof,” says:

“RESULTS: The temporal trends in prevalence rates for specific birth defects examined from 1970 through 1992 did not show changes that reflected the cessation of Bendectin use over the 1980–84 period. Further, the NVP hospitalization rate doubled when Bendectin use ceased.

CONCLUSIONS: The population results of the ecological analyses complement the person-specific results of the epidemiological analyses in finding no evidence of a teratogenic effect from the use of Bendectin.”[15]

So the cited source actually says the exact opposite of what the authors assert. Apparently, students on law review at Georgetown University Law Center do not check citations for accuracy. Not only was the statement wrong in 1993, when the Supreme Court decided the famous Daubert case, it was wrong 20 years later, in 2013, when the United States Food and Drug Administration (FDA) approved  Diclegis, a combination of doxylamine succinate and pyridoxine hydrochloride, the essential ingredients in Bendectin, for sale in the United States, for pregnant women experiencing nausea and vomiting.[16] The return of Bendectin to the market, although under a different name, was nothing less than a triumph of science over the will of the lawsuit industry.[17] 

Channeling the likes of plaintiffs’ expert witness Carl Cranor (whom they cite liberally and credulously), Ranges and Oakley argue for a vague “weight of the evidence” (WOE) methodology, in which several inconclusive and lighter-than-air pieces of evidence somehow magically combine in cold fusion to warrant a conclusion of causation. Others have gone down this dubious path before, but these authors’ embrace of the plaintiffs’ expert witnesses’ opinion in Bendectin litigation reveals the insubstantiality and the invalidity of their method.[18] As Professor Ronald Allen put the matter:

“Given the weight of evidence in favor of Bendectin’s safety, it seems peculiar to argue for mosaic evidence [WOE] from a case in which it would have plainly been misleading.”[19]

It surely seems like a reduction ad absurdum of the proposed methodology.

One thing these authors get right is that most courts disparage and exclude expert witness opinion that relies exclusively or excessively upon animal toxicology.[20] They wrongly chastise these courts, however, for ignoring scientific opinion. In 2005, the Teratology Society issued a position paper on causation in teratology-related litigation,[21] in which the Society specifically addressed the authors’ claims:

“6. Human data are required for conclusions that there is a causal relationship between an exposure and an outcome in humans. Experimental animal data are commonly and appropriately used in establishing regulatory exposure limits and are useful in addressing biologic plausibility and mechanism questions, but are not by themselves sufficient to establish causation in a lawsuit. In vitro data may be helpful in exploring mechanisms of toxicity but are not by themselves evidence of causation.”[22]

Ranges and Oakley are flummoxed that courts exclude expert witnesses who have relied upon animal studies when regulatory agencies use such studies with abandon. The case law on the distinction between precautionary standards in regulation and causation standards in tort law is clear, and explains the difference in approach, but these authors are determined to ignore the obvious difference.[23] The Teratology Society emphasized what should be hornbook law; namely, regulatory standards for testing and warnings are not particularly germane to tort law standards for causation:

“2. The determination of causation in a lawsuit is not the same as a regulatory determination of a protective level of exposure. If a government agency has determined a regulatory exposure level for a chemical, the existence of that level is not evidence that the chemical produces toxicity in humans at that level or any other level. Regulatory levels use default assumptions that are improper in lawsuits. One such assumption is that humans will be as sensitive to the toxicity of a chemical as is the most sensitive experimental animal species. This assumption may be very useful in regulation but is not evidence that exposure to that chemical caused an adverse outcome in an individual plaintiff. Regulatory levels often incorporate uncertainty factors or margins of exposure. These factors may result in a regulatory level much lower than an exposure level shown to be harmful in any organism and are an additional reason for the lack of utility of regulatory levels in causation considerations.”[24]

The suggestion from Ranges and Oakley that the judicial treatment of reliance upon animal studies is based upon ossified, ancient precedent, prejudice, and uncritical acceptance of defense counsel’s unsupported argument is simply wrong. There are numerous discussions of the difficulty of extrapolating teratogenicity from animal data to humans,[25] and ample basis for criticism of the glib extension of rodent carcinogenicity to humans.[26]

Ranges and Oakley ignore the extensive scientific literature questioning extrapolation from high exposure rodent models to much lower exposures in humans.[27] The invalidity of extrapolation can result in both false positives and false negatives. Indeed the thalidomide case is a compelling example of the failure of animal testing. Thalidomide was tested on pregnant rats and rabbits without detecting teratogenicity; indeed most animal species do not metabolize thalidomide or exhibit teratogenicity as seen in humans. Animal models simply do not have a sufficient positive predictive value to justify a conclusion of causation in humans, even if we accept a precautionary principle recognition of such animal testing for regulatory purposes.[28]

As improvident as Ranges’ pronouncements may be, finding her message amplified by Professor Ed Cheng on his podcast series, Excited Utterances, was even more disturbing. In November 2023, Cheng interviewed Kristen Ranges in an episode of his podcast, Vermin of Proof, in which he gave Ranges a chance to reprise her complaints about the judiciary’s handling of animal evidence, without much in the way of specificity, and with some credulous cheerleading to aid and abet. In his epilogue, Cheng wondered why toxicologic evidence is disfavored when such evidence is routinely used by scientists and regulators. What Cheng misses is that regulators use toxicologic evidence for regulation, not for assessments of human causation, and that the two enterprises are quite different.  The regulatory exercise goes something like asking about the stall speed of a pig. It does not matter that pigs cannot fly; we skip that fact and press on to ask what the pig’s take off and stall speeds are.

Seventy years ago, no less than Sir Austin Bradford Hill, observed that:

“We may subject mice, or other laboratory animals, to such an atmosphere of tobacco smoke that they can — like the old man in the fairy story — neither sleep nor slumber; they can neither breed nor eat. And lung cancers may or may not develop to a significant degree. What then? We may have thus strengthened the evidence, we may even have narrowed the search, but we must, I believe, invariably return to man for the final proof or proofs.”[29]


[1] Alexander Pope, “An Essay on Man” (1733), in Robin Sowerby, ed., Alexander Pope: Selected Poetry and Prose at 153 (1988).

[2] Kristen Ranges, Animals Aiding Justice: The Deepwater Horizon Oil Spill and Ensuing Neurobehavioral Impacts as a Case Study for Using Animal Models in Toxic Tort Litigation – A Dissertation (2023).

[3] Kristen Ranges & Jessica Owley, “Vermin of Proof: Arguments for the Admissibility of Animal Model Studies as Proof of Causation in Toxic Tort Litigation,” 34 Georgetown Envt’l L. Rev. 303 (2022) [Vermin]

[4] Vermin at 303.

[5] In re Agent Orange Prod. Liab. Litig., 611 F. Supp. 1223, 1241 (E.D.N.Y. 1985), aff’d, 818 F.2d 187 (2d Cir. 1987), cert. denied, 487 U.S. 1234 (1988).

[6] Id.

[7] Id.

[8] General Elec. Co. v. Joiner, 522 U.S. 136, 144 (1997) [Joiner]

[9] Joiner v. General Electric Co., 864 F. Supp. 1310 (N.D. Ga. 1994).

[10] Joiner v. General Electric Co., 134 F.3d 1457 (11th Cir. 1998) (per curiam). 

[11] Joiner, 522 U.S. at 144-45.

[12] See Leonid Roshkovan, Jeffrey C. Thompson, Sharyn I. Katz, Charuhas Deshpande, Taylor Jenkins, Anna K. Nowak, Rosyln Francis, Carole Dennie, Dominique Fabre, Sunil Singhal, and Maya Galperin-Aizenberg, “Alveolar adenoma of the lung: multidisciplinary case discussion and review of the literature,” 12 J. Thoracic Dis. 6847 (2020).

[13] See How Have Important Rule 702 Holdings Held Up With Time?” (Mar. 20, 2015); “The Joiner Finale” (Mar. 23, 2015).

[14] Vermain at 312.

[15] Jeffrey S Kutcher, Arnold Engle, Jacqueline Firth & Steven H. Lamm, “Bendectin and Birth Defects II: Ecological Analyses, 67 Birth Defects Research Part A: Clinical and Molecular Teratology 88, 88 (2003).

[16] See FDA News Release, “FDA approves Diclegis for pregnant women experiencing nausea and vomiting,” (April 8, 2013).

[17] See Gideon Koren, “The Return to the USA of the Doxylamine-Pyridoxine Delayed Release Combination (Diclegis®) for Morning Sickness — A New Morning for American Women,” 20 J. Popul. Ther. Clin. Pharmacol. e161 (2013).

[18] Michael D. Green, “Pessimism About Milward,” 3 Wake Forest J. Law & Policy41, 62-63 (2013); Susan Haack, “Irreconcilable Differences? The Troubled Marriage of Science and Law,” 72 Law & Contemporary Problems 1, 17 (2009); Susan Haack, “Proving Causation: The Holism of Warrant and the Atomism of Daubertm” 4 J. Health & Biomedical Law 273, 274-78 (2008).

[19] Ronald J. Allen & Esfand Nafisi, “Daubert and its Discontents,” 76 Brooklyn L. Rev. 132, 148 (2010). 

[20] See In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 26 F. Supp. 3d 466, 475 (E.D. Pa. 2014) (noting that “causation opinions based primarily upon in vitro and live animal studies are unreliable and do not meet the Daubert standard.”), aff’d, 858 F.3d 787 (3rd Cir. 2017); Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 1296, 1308 (11th Cir. 2014) (affirming exclusion of testimony based on “secondary methodologies,” including animal studies, which offer “insufficient proof of general causation.”); The Sugar Ass’n v. McNeil-PPC, Inc., 2008 WL 11338092, *3 (C.D. Calif. July 21, 2008) (finding that plaintiffs’ expert witnesses, including Dr. Abou-Donia, failed to provide the requisite analytical  support for the extrapolation of their Five Opinions from rats to humans”); In re Silicone Gel Breast Implants Prods. Liab. Litig., 318 F. Supp. 2d 879, 891 (C.D. Cal. 2004) (observing that failure to compare similarities and differences across animals and humans could lead to the exclusion of opinion evidence); Cagle v. The Cooper Companies, 318 F. Supp. 2d 879, 891 (C.D. Calif. 2004) (citing Joiner, for observation that animal studies are not generally admissible when contrary epidemiologic studies are available; and detailing significant disadvantages in relying upon animal studies, such as (1) differences in absorption, distribution, and metabolism; (2) the unrealistic, non-physiological exposures used in animal studies; and (3) the use of unverified assumptions about dose-response); Wills v. Amerada Hess Corp., No. 98 CIV. 7126(RPP), 2002 WL 140542, at *12 (S.D.N.Y. Jan. 31, 2002) (faulting expert’s reliance on animal studies because there was no evidence plaintiff had injected suspected carcinogen in same manner as studied animals, or at same dosage levels), aff’d, 379 F.3d 32 (2nd Cir. 2004) (Sotomayor, J.); Bourne v. E.I. du Pont de Nemours & Co., 189 F. Supp. 2d 482, 501 (S.D. W.Va. 2002) (benlate and birth defects), aff’d, 85 F. App’x 964 (4th Cir.), cert. denied, 543 U.S. 917 (2004); Magistrini v. One Hour Martinizing Dry Cleaning noted that “[a]nimal bioassays are of limited use in determining whether a particular chemical causes a particular disease, or type of cancer, in humans.”190 180 F. Supp. 2d 584, 593 (D.N.J. 2002); Soutiere v. BetzDearborn, Inc., No. 2:99-CV-299, 2002 WL  34381147, at *4 (D. Vt. July 24, 2002) (holding expert’s evidence inadmissible when “[a]t best there are animal studies that suggest a link between massive doses of [the substance in question] and the development of certain kinds of cancers, such that [the substance in question] is listed as a ‘suspected’ or ‘probable’ human carcinogen”); Glastetter v. Novartis Pharms. Corp., 252 F.3d 986, 991 (8th Cir. 2001); Hollander v. Sandoz Pharm. Corp., 95 F. Supp. 2d 1230, 1238 (W.D. Okla. 2000), aff’d, 289 F.3d 1193, 1209 (10th Cir. 2002) (rejecting the relevance of animal studies to causation arguments in the circumstances of the case); Allison v. McGhan Medical Corp., 184 F.3d 1300, 1313–14 (11th Cir.1999); Raynor v. Merrell Pharrns. Inc., 104 F.3d 1371, 1375-1377 (D.C. Cir.1997) (observing that animal studies are unreliable, especially when “sound epidemiological studies produce opposite results from non-epidemiological ones, the rate of error of the latter is likely to be quite high”); Lust v. Merrell Dow Pharms., Inc., 89 F.3d 594, 598 (9th Cir.1996); Barrett v. Atlantic Richfield Co., 95 F.3d 375 (5th Cir. 1996) (extrapolation from a rat study was speculation); Nat’l Bank of Comm. v. Dow Chem. Co., 965 F. Supp. 1490, 1527 (E.D. Ark. 1996) (“because of the difference in animal species, the methods and routes of administration of the suspect chemical agent, maternal metabolisms and other factors, animal studies, taken alone, are unreliable predictors of causation in humans”), aff’d, 133 F.3d 1132 (8th Cir. 1998); Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1410-11 (D. Or. 1996) (with the help of court-appointed technical advisors, observing that animal studies taken alone fail to predict human disease reliably); Daubert v. Merrell Dow Pharrns., Inc., 43 F.3d 1311, 1322 (9th Cir. 1995) (on remand from Supreme Court with directions to apply an epistemic standard derived from Rule 702 itself); Sorensen v. Shaklee Corp., 31 F.3d 638, 650 (8th Cir.1994) (affirming exclusion of expert witness opinions based upon animal mutagenicity data not germane to the claimed harm); Elkins v. Richardson-Merrell, Inc., 8 F.3d 1068, 1073 (6th Cir. 1993);Wade-Greaux v. Whitehall Labs., Inc., 874 F. Supp. 1441, 1482 (D.V.1. 1994), aff’d, 46 F.3d 1120 (3d Cir. 1994) (per curiam); Renaud v. Martin Marietta Corp., Inc., 972 F.2d 304, 307 (10th Cir.1992) (“The etiological evidence proffered by the plaintiff was not sufficiently reliable, being drawn from tests on non-human subjects without confirmatory epidemiological data.”) (“Dr. Jackson performed no calculations to determine whether the dose or route of administration of antidepressants to rats and monkeys in the papers that she cited in her report was equivalent to or substantially similar to human beings taking prescribed doses of Prozac.”); Bell v. Swift Adhesives, Inc., 804 F. Supp. 1577, 1579–81 (S.D. Ga. 1992) (excluding expert opinion of Dr. Janette Sherman, who opined that methylene chloride caused liver cancer, based largely upon on animal studies); Conde v. Velsicol Chem. Corp., 804 F. Supp. 972, 1025-26 (S.D. Ohio 1992) (noting that epidemiology is “the primary generally accepted methodology for demonstrating a causal relation between a chemical compound and a set of symptoms or a disease”), aff’d, 24 F.3d 809 (6th Cir. 1994); Turpin v. Merrell Dow Pharm., Inc., 959 F.2d 1349, 1360-61 (6th Cir. 1992) (“The analytical gap between the [animal study] evidence presented and the inferences to be drawn on the ultimate issue of human birth defects is too wide. Under such circumstances, a jury should not be asked to speculate on the issue of causation.”); Brock v. Merrell Dow Pharm., 874F.2d 307, 313 (5th Cir. 1989) (noting the “very limited usefulness of animal studies when confronted with questions of toxicity”); Richardson v. Richardson-Merrell, Inc., 857 F. 2d 823, 830 (D.C. Cir. 1988) (“Positive results from in vitro studies may provide a clue signaling the need for further research, but alone do not provide a satisfactory basis for opining about causation in the human context.”);  Lynch v. Merrell-Nat‘l Labs., 830 F.2d 1190, 1194 (1st Cir. 1987) (“Studies of this sort [animal studies], singly or in combination, do not have the capability of proving causation in human beings in the absence of any confirmatory epidemiological data.”). See also Merrell Dow Pharrns., Inc. v. Havner, 953 S.W.2d 706, 730 (Tex. 1997); DePyper v. Navarro, No. 83-303467-NM, 1995 WL 788828, at *34 (Mich. Cir. Ct. Nov. 27, 1995), aff’d, No. 191949, 1998 WL 1988927 (Mich. Ct. App. Nov. 6, 1998); Nelson v. American Sterilizer Co., 566 N.W.2d 671 (Mich. Ct. App. 1997)(high-dose animal studies not reliable). But see Ambrosini v. Labarraque,  101 F.3d 129, 137-140 (D.C. Cir.1996); Dyson v. Winfield, 113 F. Supp. 2d 44, 50-51 (D.D.C. 2000).

[21] Teratology Society Public Affairs Committee, “Position Paper Causation in Teratology-Related Litigation,” 73 Birth Defects Research (Part A) 421 (2005) [Teratology Position Paper]

[22] Id. at 423.

[23]  SeeImproper Reliance Upon Regulatory Risk Assessments in Civil Litigation” (Mar. 19, 2023) (collecting cases).

[24] Teratology Position Paper at 422-423.

[25] See, e.g., Gideon Koren, Anne Pastuszak & Shinya Ito, “Drugs in Pregnancy,” 338 New England J. Med. 1128, 1131 (1998); Louis Lasagna, “Predicting Human Drug Safety from Animal Studies: Current Issues,” 12 J. Toxicological Sci. 439, 442-43 (1987).

[26] Bruce N. Ames & Lois S. Gold, Too Many Rodent Carcinogens: Mitogenesis Increases Mutagenesis, 249 Science 970, 970 (1990) (noting that chronic irritation induced by many chemicals at high exposures is itself a cause of cancer in rodent models); Bruce N. Ames & Lois Swirsky Gold, “Environmental Pollution and Cancer: Some Misconceptions,” in Jay H. Lehr, ed., Rational Readings on Environmental Concerns 151, 153 (1992); Mary Eubanks, “The Danger of Extrapolation: Humans and Rodents Differ in Response to PCBs,” 112 Envt’l Health Persps. A113 (2004)

[27] Andrea Gawrylewski, “The Trouble with Animal Models: Why did human trials fail?” 21 The Scientist 44 (2007); Michael B. Bracken, “Why animal studies are often poor predictors of human reactions to exposure,” 101 J. Roy. Soc. Med. 120 (2008); Fiona Godlee, “How predictive and productive is animal research?” 3348 Brit. Med. J. g3719 (2014); John P. A. Ioannidis, “Extrapolating from Animals to Humans,” 4 Science Translational Med. 15 (2012); Pandora Pound & Michael Bracken, “Is animal research sufficiently evidence based to be a cornerstone of biomedical research?” 348 Brit. Med. J. g3387 (2014); Pandora Pound, Shah Ebrahim, Peter Sandercock, Michael B Bracken, and Ian Roberts, “Where is the evidence that animal research benefits humans?” 328 Brit. Med. J. 514 (2004) (writing on behalf of the Reviewing Animal Trials Systematically (RATS) Group).

[28] See Ray Greek, Niall Shanks, and Mark J. Rice, “The History and Implications of Testing Thalidomide on Animals,” 11 J. Philosophy, Sci. & Law 1, 19 (2011).

[29] Austin Bradford Hill, “Observation and Experiment,” 248 New Engl. J. Med. 995, 999 (1953).

The Role of Peer Review in Rule 702 and 703 Gatekeeping

November 19th, 2023

“There is no expedient to which man will not resort to avoid the real labor of thinking.”
              Sir Joshua Reynolds (1723-92)

Some courts appear to duck the real labor of thinking, and the duty to gatekeep expert witness opinions,  by deferring to expert witnesses who advert to their reliance upon peer-reviewed published studies. Does the law really support such deference, especially when problems with the relied-upon studies are revealed in discovery? A careful reading of the Supreme Court’s decision in Daubert, and of the Reference Manual on Scientific Evidence provides no support for admitting expert witness opinion testimony that relies upon peer-reviewed published studies, when the studies are invalid or are based upon questionable research practices.[1]

In Daubert v. Merrell Dow Pharmaceuticals, Inc.,[2] The Supreme Court suggested that peer review of studies relied upon by a challenged expert witness should be a factor in determining the admissibility of that expert witness’s opinion. In thinking about the role of peer-review publication in expert witness gatekeeping, it is helpful to remember the context of how and why the Supreme was talking about peer review in the first place. In the trial court, the Daubert plaintiff had proffered an expert witness opinion that featured reliance upon an unpublished reanalysis of published studies. On the defense motion, the trial court excluded the claimant’s witness,[3] and the Ninth Circuit affirmed.[4] The intermediate appellate court expressed its view that unpublished, non-peer-reviewed reanalyses were deviations from generally accepted scientific discourse, and that other appellate courts, considering the alleged risks of Bendectin, refused to admit opinions based upon unpublished, non-peer-reviewed reanalyses of epidemiologic studies.[5] The Circuit expressed its view that reanalyses are generally accepted by scientists when they have been verified and scrutinized by others in the field. Unpublished reanalyses done for solely for litigation would be an insufficient foundation for expert witness opinion.[6]

The Supreme Court, in Daubert, evaded the difficult issues involved in evaluating a statistical analysis that has not been published by deciding the case on the ground that the lower courts had applied the wrong standard.  The so-called Frye test, or what I call the “twilight zone” test comes from the heralded 1923 case excluding opinion testimony based upon a lie detector:

“Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while the courts will go a long way in admitting expert testimony deduced from a well recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs.”[7]

The Supreme Court, in Daubert, held that with the promulgation of the Federal Rules of Evidence in 1975, the twilight zone test was no longer legally valid. The guidance for admitting expert witness opinion testimony lay in Federal Rule of Evidence 702, which outlined an epistemic test for “knowledge,” which would be helpful to the trier of fact. The Court then proceeded to articulate several  non-definitive factors for “good science,” which might guide trial courts in applying Rule 702, such as testability or falsifiability, a showing of known or potential error rate. Another consideration, general acceptance carried over from Frye as a consideration.[8] Courts have continued to build on this foundation to identify other relevant considerations in gatekeeping.[9]

One of the Daubert Court’s pertinent considerations was “whether the theory or technique has been subjected to peer review and publication.”[10] The Court, speaking through Justice Blackmun, provided a reasonably cogent, but probably now out-dated discussion of peer review:

 “Publication (which is but one element of peer review) is not a sine qua non of admissibility; it does not necessarily correlate with reliability, see S. Jasanoff, The Fifth Branch: Science Advisors as Policymakers 61-76 (1990), and in some instances well-grounded but innovative theories will not have been published, see Horrobin, “The Philosophical Basis of Peer Review and the Suppression of Innovation,” 263 JAMA 1438 (1990). Some propositions, moreover, are too particular, too new, or of too limited interest to be published. But submission to the scrutiny of the scientific community is a component of “good science,” in part because it increases the likelihood that substantive flaws in methodology will be detected. See J. Ziman, Reliable Knowledge: An Exploration of the Grounds for Belief in Science 130-133 (1978); Relman & Angell, “How Good Is Peer Review?,” 321 New Eng. J. Med. 827 (1989). The fact of publication (or lack thereof) in a peer reviewed journal thus will be a relevant, though not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which an opinion is premised.”[11]

To the extent that peer review was touted by Justice Blackmun, it was because the peer-review process advanced the ultimate consideration of the scientific validity of the opinion or claim under consideration. Validity was the thing; peer review was just a crude proxy.

If the Court were writing today, it might well have written that peer review is often a feature of bad science, advanced by scientists who know that peer-reviewed publication is the price of admission to the advocacy arena. And of course, the wild proliferation of journals, including the “pay-to-play” journals, facilitates the festschrift.

Reference Manual on Scientific Evidence

Certainly, judicial thinking evolved since 1993, and the decision in Daubert. Other considerations for gatekeeping have been added. Importantly, Daubert involved the interpretation of a statute, and in 2000, the statute was amended.

Since the Daubert decision, the Federal Judicial Center and the National Academies of Science have weighed in with what is intended to be guidance for judges and lawyers litigating scientific and technical issue. The Reference Manual on Scientific Evidence is currently in a third edition, but a fourth edition is expected in 2024.

How does the third edition[12] treat peer review?

An introduction by now retired Associate Justice Stephen Breyer blandly reports the Daubert considerations, without elaboration.[13]

The most revealing and important chapter in the Reference Manual is the one on scientific method and procedure, and sociology of science, “How Science Works,” by Professor David Goodstein.[14] This chapter’s treatment is not always consistent. In places, the discussion of peer review is trenchant. At other places, it can be misleading. Goodstein’s treatment, at first, appears to be a glib endorsement of peer review as a substitute for critical thinking about a relied-upon published study:

“In the competition among ideas, the institution of peer review plays a central role. Scientifc articles submitted for publication and proposals for funding often are sent to anonymous experts in the field, in other words, to peers of the author, for review. Peer review works superbly to separate valid science from nonsense, or, in Kuhnian terms, to ensure that the current paradigm has been respected.11 It works less well as a means of choosing between competing valid ideas, in part because the peer doing the reviewing is often a competitor for the same resources (space in prestigious journals, funds from government agencies or private foundations) being sought by the authors. It works very poorly in catching cheating or fraud, because all scientists are socialized to believe that even their toughest competitor is rigorously honest in the reporting of scientific results, which makes it easy for a purposefully dishonest scientist to fool a referee. Despite all of this, peer review is one of the venerated pillars of the scientific edifice.”[15]

A more nuanced and critical view emerges in footnote 11, from the above-quoted passage, when Goodstein discusses how peer review was framed by some amici curiae in the Daubert case:

“The Supreme Court received differing views regarding the proper role of peer review. Compare Brief for Amici Curiae Daryl E. Chubin et al. at 10, Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) (No. 92-102) (“peer review referees and editors limit their assessment of submitted articles to such matters as style, plausibility, and defensibility; they do not duplicate experiments from scratch or plow through reams of computer-generated data in order to guarantee accuracy or veracity or certainty”), with Brief for Amici Curiae New England Journal of Medicine, Journal of the American Medical Association, and Annals of Internal Medicine in Support of Respondent, Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) (No. 92-102) (proposing that publication in a peer-reviewed journal be the primary criterion for admitting scientifc evidence in the courtroom). See generally Daryl E. Chubin & Edward J. Hackett, Peerless Science: Peer Review and U.S. Science Policy (1990); Arnold S. Relman & Marcia Angell, How Good Is Peer Review? 321 New Eng. J. Med. 827–29 (1989). As a practicing scientist and frequent peer reviewer, I can testify that Chubin’s view is correct.”[16]

So, if, as Professor Goodstein attests, Chubin is correct that peer review does not “guarantee accuracy or veracity or certainty,” the basis for veneration is difficult to fathom.

Later in Goodstein’s chapter, in a section entitled “V. Some Myths and Facts about Science,” the gloves come off:[17]

Myth: The institution of peer review assures that all published papers are sound and dependable.

Fact: Peer review generally will catch something that is completely out of step with majority thinking at the time, but it is practically useless for catching outright fraud, and it is not very good at dealing with truly novel ideas. Peer review mostly assures that all papers follow the current paradigm (see comments on Kuhn, above). It certainly does not ensure that the work has been fully vetted in terms of the data analysis and the proper application of research methods.”[18]

Goodstein is not a post-modern nihilist. He acknowledges that “real” science can be distinguished from “not real science.” He can hardly be seen to have given a full-throated endorsement to peer review as satisfying the gatekeeper’s obligation to evaluate whether a study can be reasonably relied upon, or whether reliance upon such a particular peer-reviewed study can constitute sufficient evidence to render an expert witness’s opinion helpful, or the application of a reliable methodology.

Goodstein cites, with apparent approval, the amicus brief filed by the New England Journal of Medicine, and other journals, which advised the Supreme Court that “good science,” requires a “a rigorous trilogy of publication, replication and verification before it is relied upon.” [19]

“Peer review’s ‘role is to promote the publication of well-conceived articles so that the most important review, the consideration of the reported results by the scientific community, may occur after publication.’”[20]

Outside of Professor Goodstein’s chapter, the Reference Manual devotes very little ink or analysis to the role of peer review in assessing Rule 702 or 703 challenges to witness opinions or specific studies.  The engineering chapter acknowledges that “[t]he topic of peer review is often raised concerning scientific and technical literature,” and helpfully supports Goodstein’s observations by noting that peer review “does not ensure accuracy or validity.”[21]

The chapter on neuroscience is one of the few chapters in the Reference Manual, other than Professor Goodstein’s, to address the limitations of peer review. Peer review, if absent, is highly suspicious, but its presence is only the beginning of an evaluation process that continues after publication:

Daubert’s stress on the presence of peer review and publication corresponds nicely to scientists’ perceptions. If something is not published in a peer-reviewed journal, it scarcely counts. Scientists only begin to have confidence in findings after peers, both those involved in the editorial process and, more important, those who read the publication, have had a chance to dissect them and to search intensively for errors either in theory or in practice. It is crucial, however, to recognize that publication and peer review are not in themselves enough. The publications need to be compared carefully to the evidence that is proffered.[22]

The neuroscience chapter goes on to discuss peer review also in the narrow context of functional magnetic resonance imaging (fMRI). The authors note that fMRI, as a medical procedure, has been the subject of thousands of peer-reviewed, but those peer reviews do little to validate the use of fMRI as a high-tech lie detector.[23] The mental health chapter notes in a brief footnote that the science of memory is now well accepted and has been subjected to peer review, and that “[c]areful evaluators” use only tests that have had their “reliability and validity confirmed in peer-reviewed publications.”[24]

Echoing other chapters, the engineering chapter also mentions peer review briefly in connection with qualifying as an expert witness, and in validating the value of accrediting societies.[25]  Finally, the chapter points out that engineering issues in litigation are often sufficiently novel that they have not been explored in peer-reviewed literature.[26]

Most of the other chapters of the Reference Manual, third edition, discuss peer review only in the context of qualifications and membership in professional societies.[27] The chapter on exposure science discusses peer review only in the narrow context of a claim that EPA guidance documents on exposure assessment are peer reviewed and are considered “authoritative.”[28]

Other chapters discuss peer review briefly and again only in very narrow contexts. For instance, the epidemiology chapter discusses peer review in connection with two very narrow issues peripheral to Rule 702 gatekeeping. First, the chapter raises the question (without providing a clear answer) whether non-peer-reviewed studies should be included in meta-analyses.[29] Second, the chapter asserts that “[c]ourts regularly affirm the legitimacy of employing differential diagnostic methodology,” to determine specific causation, on the basis of several factors, including the questionable claim that the methodology “has been subjected to peer review.”[30] There appears to be no discussion in this key chapter about whether, and to what extent, peer review of published studies can or should be considered in the gatekeeping of epidemiologic testimony. There is certainly nothing in the epidemiology chapter, or for that matter elsewhere in the Reference Manual, to suggest that reliance upon a peer-reviewed published study pretermits analysis of that study to determine whether it is indeed internally valid or reasonably relied upon by expert witnesses in the field.


[1] See Jop de Vrieze, “Large survey finds questionable research practices are common: Dutch study finds 8% of scientists have committed fraud,” 373 Science 265 (2021); Yu Xie, Kai Wang, and Yan Kong, “Prevalence of Research Misconduct and Questionable Research Practices: A Systematic Review and Meta-Analysis,” 27 Science & Engineering Ethics 41 (2021).

[2] 509 U.S. 579 (1993).

[3]  Daubert v. Merrell Dow Pharmaceuticals, Inc., 727 F.Supp. 570 (S.D.Cal.1989).

[4] 951 F. 2d 1128 (9th Cir. 1991).

[5]  951 F. 2d, at 1130-31.

[6] Id. at 1131.

[7] Frye v. United States, 293 F. 1013, 1014 (D.C. Cir. 1923) (emphasis added).

[8]  Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 590 (1993).

[9] See, e.g., In re TMI Litig. II, 911 F. Supp. 775, 787 (M.D. Pa. 1995) (considering the relationship of the technique to methods that have been established to be reliable, the uses of the method in the actual scientific world, the logical or internal consistency and coherence of the claim, the consistency of the claim or hypothesis with accepted theories, and the precision of the claimed hypothesis or theory).

[10] Id. at  593.

[11] Id. at 593-94.

[12] National Research Council, Reference Manual on Scientific Evidence (3rd ed. 2011) [RMSE]

[13] Id., “Introduction” at 1, 13

[14] David Goodstein, “How Science Works,” RMSE 37.

[15] Id. at 44-45.

[16] Id. at 44-45 n. 11 (emphasis added).

[17] Id. at 48 (emphasis added).

[18] Id. at 49 n.16 (emphasis added)

[19] David Goodstein, “How Science Works,” RMSE 64 n.45 (citing Brief for the New England Journal of Medicine, et al., as Amici Curiae supporting Respondent, 1993 WL 13006387 at *2, in Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993).

[20] Id. (citing Brief for the New England Journal of Medicine, et al., 1993 WL 13006387 *3)

[21] Channing R. Robertson, John E. Moalli, David L. Black, “Reference Guide on Engineering,” RMSE 897, 938 (emphasis added).

[22] Henry T. Greely & Anthony D. Wagner, “Reference Guide on Neuroscience,” RMSE 747, 786.

[23] Id. at 776, 777.

[24] Paul S. Appelbaum, “Reference Guide on Mental Health Evidence,” RMSE 813, 866, 886.

[25] Channing R. Robertson, John E. Moalli, David L. Black, “Reference Guide on Engineering,” RMSE 897, 901, 931.

[26] Id. at 935.

[27] Daniel Rubinfeld, “Reference Guide on Multiple Regression,” 303, 328 RMSE  (“[w]ho should be qualified as an expert?”); Shari Seidman Diamond, “Reference Guide on Survey Research,” RMSE 359, 375; Bernard D. Goldstein & Mary Sue Henifin, “Reference Guide on Toxicology,” RMSE 633, 677, 678 (noting that membership in some toxicology societies turns in part on having published in peer-reviewed journals).

[28] Joseph V. Rodricks, “Reference Guide on Exposure Science,” RMSE 503, 508 (noting that EPA guidance documents on exposure assessment often are issued after peer review).

[29] Michael D. Green, D. Michal Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” RMSE 549, 608.

[30] Id. at 617-18 n.212.

Collegium Ramazzini & Its Fellows – The Lobby

November 19th, 2023

Back in 1997, Francis Douglas Kelly Liddell, a real scientist in the area of asbestos and disease, had had enough of the insinuations, slanders, and bad science from the minions of Irving John Selikoff.[1] Liddell broke with the norms of science and called out his detractors for what they were doing:

 “[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.”[2]

What Liddell did not realize is that the Lobby had become institutionalized in the form of an organization, the Collegium Ramazzini, started by Selikoff under false pretenses.[3] Although the Collegium operates with some degree of secrecy, the open and sketchy conduct of its members suggest that we could use the terms “the Lobby” and “the Collegium Ramazzini,” interchangeably.

Ramazzini founder Irving Selikoff had an unfortunate track record for perverting the course of justice. Selikoff conspired with Ron Motley and others to bend judges with active asbestos litigation dockets by inviting them to a one-sided conference on asbestos science, and to pay for their travel and lodging. Presenters included key expert witnesses for plaintiffs; defense expert witnesses were conspicuously not invited to the conference. In his invitation to this ex parte soirée, Selikoff failed to mention that the funding came from plaintiffs’ counsel. Selikoff’s shenanigans led to the humiliation and disqualification of James M. Kelly,[4] the federal judge in charge of the asbestos school property damage litigation,

Neither Selikoff nor the co-conspirator counsel for plaintiffs ever apologized for their ruse. The disqualification did lead to a belated disclosure and mea culpa from the late Judge Jack Weinstein. Because of a trial in progress, Judge Weinstein did not attend the plaintiffs’ dog-and-pony show, Selikoff’s so-called “Third Wave” conference, but Judge Weinstein and a New York state trial judge, Justice Helen Freedman, attended an ex parte private luncheon meeting with Dr. Selikoff. Here is how Judge Weinstein described the event:

“But what I did may have been even worse [than Judge Kelly’s conduct that led to his disqualification]. A state judge and I were attempting to settle large numbers of asbestos cases. We had a private meeting with Dr. Irwin [sic] J. Selikoff at his hospital office to discuss the nature of his research. He had never testified and would never testify. Nevertheless, I now think that it was a mistake not to have informed all counsel in advance and, perhaps, to have had a court reporter present and to have put that meeting on the record.”[5]

Judge Weinstein’s false statement that Selikoff “had never testified”[6] not only reflects an incredible and uncharacteristic naiveté by a distinguished evidence law scholar, but the false statement was in a journal, Judicature, which was, and is, widely circulated to state and federal judges. The source of the lie appears to have been Selikoff himself in the ethically dodgy ex parte meeting with judges actively presiding over asbestos personal injury cases.

The point apparently weighed on Judge Weinstein’s conscience. He repeated his mea culpa almost verbatim, along with the false statement about Selikoff’s having never testified, in a law review article in 1994, and then incorporated the misrepresentation into a full-length book.[7] I have no doubt that Judge Weinstein did not intend to mislead anyone; like many others, he had been duped by Selikoff’s deception.

There is no evidence that Selikoff was acting as an authorized agent for the Collegium Ramazzini in conspiring to influence trial judges, or in lying to Judge Weinstein and Justice Freedman, but Selikoff was the founder of the Collegium, and his conduct seems to have set a norm for the organization. Furthermore, the Third-Wave Conference was sponsored by the Collegium. Two years later, the Collegium created an award in Selikoff’s name, in 1993, not long after the Third Wave misconduct.[8] Perhaps the award was the Collegium’s ratification of Selikoff’s misdeeds. Two of the recipients, Stephen M. Levin, and Yasunosuke Suzuki, were “regulars,” as expert witnesses for plaintiffs in asbestos litigation. The Selikoff Award is funded by the Irving J. Selikoff Endowment of the Collegium Ramazzini. The Collegium can fairly be said to be the continuation of Selikoff’s work in the form of advocacy organization.

Selikoff’s Third-Wave Conference and his lies to two key judges would not be the last of efforts to pervert the course of justice. With the Selikoff imprimatur and template in hand, Fellows of the Collegium have carried on, by carrying on. Collegium Fellows Carl F. Cranor and Thomas Smith Martyn Thomas served as partisan paid expert witnesses in the notorious Milward case.[9]

After the trial court excluded the proffered opinions of Cranor and Smith, plaintiff appealed, with the help of an amicus brief filed by The Council for Education and Research on Toxics (CERT). The plaintiffs’ counsel, Cranor and Smith, CERT, and counsel for CERT all failed to disclose that CERT was founded by the two witnesses, Cranor and Smith, whose exclusion was at the heart of the appeal.[10] Among the 27 signatories to the CERT amicus brief, a majority (15) were fellows of the Collegium Ramazzini. Others may have been members but not fellows. Many of the signatories, whether or not members or fellows of the Collegium, were frequent testifiers for plaintiffs’ counsel.

None raised any ethical qualms about the obvious conflict of interest on how scrupulous gatekeeping might hurt their testimonial income, or their (witting or unwitting) participation in CERT’s conspiracy to pervert the course of justice.[11]

The CERT amici signatories are listed below. The bold  names are identified as Collegium fellows at its current website. Others may have been members but not fellows. The asterisks indicate those who have testified in tort litigation; please accept my apologies if I missed anyone.

Nicholas A. Ashford,
Nachman Brautbar,*
David C. Christiani,*
Richard W. Clapp,*
James Dahlgren,*
Devra Lee Davis,
Malin Roy Dollinger,*
Brian G. Durie,
David A. Eastmond,
Arthur L. Frank,*
Frank H. Gardner,
Peter L. Greenberg,
Robert J. Harrison,
Peter F. Infante,*
Philip J. Landrigan,
Barry S. Levy,*
Melissa A. McDiarmid,
Myron Mehlman,
Ronald L. Melnick,*
Mark Nicas,*
David Ozonoff,*
Stephen M. Rappaport,
David Rosner,*
Allan H. Smith,*
Daniel Thau Teitelbaum,*
Janet Weiss,* and
Luoping Zhang

This D & C (deception and charade) was repeated on other occasions when Collegium fellows and members signed amicus briefs without any disclosures of conflicts of interest. In Rost v. Ford Motor Co.,[12] for instance, an amicus brief was filed by by “58 physicians and scientists,” many of whom were Collegium fellows.[13]

Ramazzini Fellows David Michaels and Celeste Monforton were both involved in the notorious Project on Scientific Knowledge and Public Policy (SKAPP) organization, which consistently misrepresented its funding from plaintiffs’ lawyers as having come from a “court fund.”[14]

Despite Selikoff’s palaver about how the Collegium would seek consensus and open discussions, it has become an echo-chamber for the rent-seeking mass-tort lawsuit industry, for the hyperbolic critics of any industry position, and for the credulous shills for any pro-labor position. In its statement about membership, the Collegium warns that

“Persons who have any type of links which may compromise the authenticity of their commitment to the mission of the Collegium Ramazzini do not qualify for Fellowship. Likewise, persons who have any conflict of interest that may negatively affect his or her impartiality as a researcher should not be nominated for Fellowship.”

This exclusionary criterion ensures lack of viewpoint diversity, and makes the Collegium an effective proxy for the law industry in the United States.

Among the Collegium’s current and past fellows, we can find many familiar names from the annals of tort litigation, all expert witnesses for plaintiffs, and virtually always only for plaintiffs. After over 40 years at the bar, I do not recognize a single name of anyone who has ever testified on behalf of a defendant in a tort case.

Henry A. Anderson

Barry I. Castleman      

Martin Cherniack

David Christiani 

Arthur Frank

Lennart Hardell 

David G. Hoel

Stephen M. Levin

Ronald L. Melnick

David Michaels

Celeste Monforton

Albert Miller

Brautbar Nachman

Christopher Portier

Steven B. Markowitz

Christine Oliver                 

Colin L, Soskolne

Yasunosuke Suzuki

Daniel Thau Teitelbaum

Laura Welch


[1]The Lobby – Cut on the Bias” (July 6, 2020).

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

[3] SeeThe Dodgy Origins of the Collegium Ramazzini” (Nov. 15, 2023).

[4] In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992). See Cathleen M. Devlin, “Disqualification of Federal Judges – Third Circuit Orders District Judge James McGirr Kelly to Disqualify Himself So As To Preserve ‘The Appearance of Justice’ Under 28 U.S.C. § 455 – In re School Asbestos Litigation (1992),” 38 Villanova L. Rev. 1219 (1993); Bruce A. Green, “May Judges Attend Privately Funded Educational Programs? Should Judicial Education Be Privatized?: Questions of Judicial Ethics and Policy,” 29 Fordham Urb. L.J. 941, 996-98 (2002).

[5] Jack B. Weinstein, “Learning, Speaking, and Acting: What Are the Limits for Judges?” 77 Judicature 322, 326 (May-June 1994) (emphasis added).

[6]Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010).

[7] See Jack B. Weinstein, “Limits on Judges’ Learning, Speaking and Acting – Part I- Tentative First Thoughts: How May Judges Learn?” 36 Ariz. L. Rev. 539, 560 (1994) (“He [Selikoff] had never testified and would   never testify.”); Jack B. Weinstein, Individual Justice in Mass Tort Litigation: The Effect of Class Actions, Consolidations, and other Multi-Party Devices 117 (1995) (“A court should not coerce independent eminent scientists, such as the late Dr. Irving Selikoff, to testify if, like he, they prefer to publish their results only in scientific journals.”).

[8] See also “The Selikoff – Castleman Conspiracy” (Mar. 13, 2011).

[9] Milward v. Acuity Specialty Products Group, Inc., 664 F.Supp.2d 137, 140 (D.Mass.2009), rev’d, 639 F. 3d 11 (1st Cir. 2011), cert. denied, 132 S.Ct. 1002 (2012).

[10]  See “The Council for Education and Research on Toxics” (July 9, 2013).

[11]Carl Cranor’s Inference to the Best Explanation” (Dec. 12, 2021).

[12] Rost v. Ford Motor Co., 151 A.3d 1032, 1052 (Pa. 2016).

[13]The Amicus Curious Brief” (Jan. 4, 2018).

[14] See, e.g., “SKAPP A LOT” (April 30, 2010); “Manufacturing Certainty” (Oct. 25, 2011); “David Michaels’ Public Relations Problem” (Dec. 2, 2011); “Conflicted Public Interest Groups” (Nov. 3, 2013).

The Dodgy Origins of the Collegium Ramazzini

November 15th, 2023

Or How Irving Selikoff and His Lobby (the Collegium Ramazzini) Fooled the Monsanto Corporation

Anyone who litigates occupational or environmental disease cases has heard of the Collegium Ramazzini. The group is named after a 17th century Italian physician, Bernardino Ramazzini, who is sometimes referred to as the father of occupational medicine.[1] His children have been an unruly lot. In Ramazzini’s honor, the Collegium was founded just over 40 years old, to acclaim and promises of neutrality and consensus.

Back in May 1983, a United Press International reporter chronicled the high aspirations and the bipartisan origins of the Collegium.[2] The UPI reporter noted that the group was founded by the late Irving Selikoff, who is also well known in litigation circles. Selikoff held himself out as an authority on occupational and environmental medicine, but his actual training in medicine was dodgy. His training in epidemiology and statistics was non-existent.

Selikoff was, however, masterful at marketing and prosyletizing. Selikoff would become known for misrepresenting his training, and creating a mythology that he did not participate in litigation, that crocidolite was not used in products in the United State, and that asbestos would become a major cause of cancer in the United States, among other things.[3] It is thus no surprise that Selikoff successfully masked the intentions of the Ramazzini group, and was thus able to capture the support of two key legislators, Senators Charles Mathias (Rep., Maryland) and Frank Lautenberg (Dem., New Jersey), along with officials from both organized labor and industry.

Selikoff was able to snooker the Senators and officials with empty talk of a new organization that would work to obtain scientific consensus on occupational and environmental issues. It did not take long after its founding in 1983 for the Collegium to become a conclave of advocates and zealots.

The formation of the Collegium may have been one of Selikoff’s greatest deceptions. According to the UPI news report, Selikoff represented that the Collegium would not lobby or seek to initiate legislation, but rather would interpret scientific findings in accessible language, show the policy implications of these findings, and make recommendations. This representation was falsified fairly quickly, but certainly by 1999, when the Collegium called for legislation banning the use of asbestos.  Selikoff had promised that the Collegium

“will advise on the adequacy of a standard, but will not lobby to have a standard set. Our function is not to condemn, but rather to be a conscience among scientists in occupational and environmental health.”

The Adventures of Pinocchio (1883); artwork by Enrico Mazzanti

Senator Mathias proclaimed the group to be “dedicated to the improvement of the human condition.” Perhaps no one was more snookered than the Monsanto Corporation, which helped fund the Collegium back in 1983. Monte Throdahl, a Monsanto senior vice president, reportedly expressed his hopes that the group would emphasize the considered judgments of disinterested scientists and not the advocacy and rent seeking of “reporters or public interests groups” on occupational medical issues. Forty years in, those hopes are long since gone. Recent Collegium meetings have been sponsored and funded by the National Institute for Environmental Sciences, Centers for Disease Control, National Cancer Institute, and Environmental Protection Agency. The time has come to cut off funding.


[1] Giuliano Franco & Francesca Franco, “Bernardino Ramazzini: The Father of Occupational Medicine,” 91 Am. J. Public Health 1382 (2001).

[2] Drew Von Bergen, “A group of international scientists, backed by two senators,” United Press International (May 10, 1983).

[3]Selikoff Timeline & Asbestos Litigation History” (Feb. 26, 2023); “The Lobby – Cut on the Bias” (July 6, 2020); “The Legacy of Irving Selikoff & Wicked Wikipedia” (Mar. 1, 2015). See also “Hagiography of Selikoff” (Sept. 26, 2015);  “Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas” (Oct. 4, 2014); “Irving Selikoff – Media Plodder to Media Zealot” (Sept. 9, 2014).; “Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff” (Jan. 4, 2014); “Selikoff and the Mystery of the Disappearing Amphiboles” (Dec. 10, 2010); “Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010).

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