TORTINI

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

PLPs & Five-Legged Dogs

September 1st, 2023

All lawyers have heard the puzzle of “how many legs does a dog have if you call his tail a leg?” The puzzle is often misattributed to Abraham Lincoln, who used the puzzle at various times, including in jury speeches. The answer of course is: “Four. Saying that a tail is a leg does not make it a leg.” Quote investigators have traced the puzzle as far back as 1825, when newspapers quoted legislator John W. Hulbert as saying that something “reminded him of the story.”[1]

What do we call a person who becomes pregnant and delivers a baby?

A woman.

The current, trending fashion is to call such a person a PLP, a person who becomes pregnant and lactates. This façon de parler is particularly misleading if it is meant as an accommodation to the transgender population. Transgender women will not show up as pregnant or lactating, and transgender men will show up only if there transition is incomplete and has left them with functional female reproductive organs.

In 2010, Guinness World Records named Thomas Beatie the “World’s First Married Man to Give Birth.” Thomas Beatie is now legally a man, which is just another way of saying that he chose to identify as a man, and gained legal recognition for his choice. Beatie was born as a female, matured into a woman, and had ovaries and a uterus. Beatie was, in other words, biologically a female when she went through puberty and became biologically a woman.

Beatie underwent partial gender reassignment surgery, consisting at least of double mastectomy, and taking testosterone replacement therapy (off label), but retained ovaries and a uterus.

Guinness makes a fine stout, and we may look upon it kindly for having nurtured the statistical thinking of William Sealy Gosset. Guinness, however, cannot make a dog have five legs simply by agreeing to call its tail a leg. Beatie was not the first pregnant man; rather he was the first person, born with functional female reproductive organs, to have his male gender identity recognized by a state, who then conceived and delivered a newborn. If Guinness wants to call this the first “legal man” to give birth, by semantic legerdemain, that is fine. Certainly we can and should publicly be respectful of transgendered persons, and work to prevent them from being harassed or embarrassed. There may well be many situations in which we would change our linguistic usage to acknowledge a transsexual male as the mother of a child.[2] We do not, however, have to change biology to suit their choices, or to make useless gestures to have them feel included when their inclusion is not relevant to important scientific and medical issues.

Sadly, the NASEM would impose this politico-semanticism upon us while addressing the serious issue whether women of child-bearing age should be included in clinical trials.  At a recent workshop on “Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons,”[3] the Academies introduced a particularly ugly neologism, “pregnant and lactating persons,” or PLP for short. The workshop reports:

“Approximately 4 million pregnant people in the United States give birth annually, and 70 percent of these individuals take at least one prescription medication during their pregnancy. Yet, pregnant and lactating persons are often excluded from clinical trials, and often have to make treatment decisions without an adequate understanding of the benefits and risks to themselves and their developing fetus or newborn baby. An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will develop a framework for addressing medicolegal and liability issues when planning or conducting research specific to pregnant and lactating persons.”[4]

The full report from NASEM, with fulsome use of the PLP phrase, is now available.[5]

J.K. Rowling is not the only one who is concerned about the erasure of the female from our discourse. Certainly we can acknowledge that transgenderism is real, without allowing the exception to erase biological facts about reproduction. After all, Guinness’s first pregnant “legal man” could not lactate, as a result of bilateral mastectomies, and thus the “legal man” was not a pregnant person who could lactate. And the pregnant “legal man” had functioning ovaries and uterus, which is not a matter of gender identity, but physiological functioning of biological female sex organs. Furthermore, including transgendered women, or “legal women,” without functional ovaries and uterus, in clinical trials will not answer difficult question about whether experimental therapies may harm women’s reproductive function or their offspring in utero or after birth.

The inclusion of women in clinical trials is a serious issue precisely because experimental therapies may hold risks for participating women’s offspring in utero. The law may not permit a proper informed consent by women for their conceptus. And because of the new latitude legislatures enjoy to impose religion-based bans on abortion, a women who conceives while taking an experimental drug may not be able to terminate her pregnancy that has been irreparably harmed by the drug.

The creation of the PLP category really confuses rather than elucidates how we answer the ethical and medical questions involved in testing new drugs or treatments for women. NASEM’s linguistic gerrymandering may allow some persons who have suffered from gender dysphoria to feel “included,” and perhaps to have their choices “validated,” but the inclusion of transgender women, or partially transgendered men, will not help answer the important questions facing clinical researchers. Taxpayers who fund NASEM and NIH deserve better clarity and judgment in the use of governmental funds in supporting clinical trials.

When and whence comes this PLP neologism?  An N-Gram search shows that “pregnant person” was found in the database before 1975, and that the phrase has waxed and waned since.

N-Gram for pregnant person, conducted September 1, 2023

A search of the National Library of Medicine PubMed database found several dozen hits, virtually all within the last two years. The earliest use was in 1970,[6] with a recrudenscence 11 years later.[7]

                                             

From PubMed search for “pregnant person,” conducted Sept. 1, 2023 

In 2021, the New England Journal of Medicine published a paper on the safety of Covid-19 vaccines in “pregnant persons.”[8] As of last year, the Association of American Medical Colleges sponsored a report about physicians advocating for inclusion of “pregnant people” in clinical trials, in a story that noted that “[p]regnant patients are often excluded from clinical trials for fear of causing harm to them or their babies, but leaders in maternal-fetal medicine say the lack of data can be even more harmful.”[9] And currently, the New York State Department of Health advises that “[d]ue to changes that occur during pregnancy, pregnant people may be more susceptible to viral respiratory infections.”[10]

The neologism of PLP was not always so. Back in the dark ages, 2008, the National Cancer Institute issued guidelines on the inclusion of pregnant and breast-feeding women in clinical trials.[11] As recently as June 2021, The World Health Organization was still old school in discussing “pregnant and lactating women.”[12] The same year, over a dozen female scientists, published a call to action about the inclusion of “pregnant women” in COVID-19 trials.[13]

Two years ago, I gingerly criticized the American Medical Association’s issuance of a linguistic manifesto on how physicians and scientists should use language to advance the Association’s notions of social justice.[14] I criticized the Association’s efforts at the time, but its guide to “correct” usage was devoid of the phrase “pregnant persons” or “lactating persons.”[15] Pregnancy is a function of sex, not of gender.


[1]Suppose You Call a Sheep’s Tail a Leg, How Many Legs Will the Sheep Have?” QuoteResearch (Nov. 15, 2015).

[2] Sam Dylan More, “The pregnant man – an oxymoron?” 7 J. Gender Studies 319 (1998).

[3] National Academies of Sciences, Engineering, and Medicine, “Research with Pregnant and Lactating Persons: Mitigating Risk and Liability: Proceedings of a Workshop in Brief,” (2023).

[4] NASEM, “Research with Pregnant and Lactating Persons: Mitigating Risk and Liability: Proceedings of a Workshop–in Brief” (2023).

[5] National Academies of Sciences, Engineering, and Medicine, Inclusion of pregnant and lactating persons in clinical trials: Proceedings of a workshop (2023).

[6] W.K. Keller, “The pregnant person,” 68 J. Ky. Med. Ass’n 454 (1970).

[7] Vibiana M. Andrade, “The toxic workplace: Title VII protection for the potentially pregnant person,” 4 Harvard Women’s Law J. 71 (1981).

[8] Tom T. Shimabukuro, Shin Y. Kim, Tanya R. Myers, Pedro L. Moro, Titilope Oduyebo, Lakshmi Panagiotakopoulos, Paige L. Marquez, Christine K. Olson, Ruiling Liu, Karen T. Chang, Sascha R. Ellington, Veronica K. Burkel, et al., for the CDC v-safe COVID-19 Pregnancy Registry Team, “Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons,” 384 New Engl. J. Med. 2273 (2021).

[9] Bridget Balch, “Prescribing without data: Doctors advocate for the inclusion of pregnant people in clinical research,” AAMC (Mar. 22, 2022).

[10] New York State Department of Health, “Pregnancy & COVID-19,” last visited August 31, 2023.

[11] NCI, “Guidelines Regarding the Inclusion of Pregnant and Breast-Feeding Women on Cancer Clinical Treatment Trials,” (May 29, 2008).

[12] WHO, “Update on WHO Interim recommendations on COVID-19 vaccination of pregnant and lactating women,” (June 10, 2021).

[13] Melanie M. Taylor, Loulou Kobeissi, Caron Kim, Avni Amin, Anna E Thorson, Nita B. Bellare, Vanessa Brizuela, Mercedes Bonet, Edna Kara, Soe Soe Thwin, Hamsadvani Kuganantham, Moazzam Ali, Olufemi T. Oladapo, Nathalie Broutet, “Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action,”9 Health Policy E366 (2021).

[14] American Medical Association, “Advancing Health Equity: A Guide to Language, Narrative and Concepts,” (2021); see Harriet Hall, “The AMA’s Guide to Politically Correct Language: Advancing Health Equity,” Science Based Medicine (Nov. 2, 2021).

[15]When the American Medical Association Woke Up” (Nov.17, 2021).

Excluding Epidemiologic Evidence under Federal Rule of Evidence 702

August 26th, 2023

We are 30-plus years into the “Daubert” era, in which federal district courts are charged with gatekeeping the relevance and reliability of scientific evidence. Not surprisingly, given the lawsuit industry’s propensity on occasion to use dodgy science, the burden of awakening the gatekeepers from their dogmatic slumber often falls upon defense counsel in civil litigation. It therefore behooves defense counsel to speak carefully and accurately about the grounds for Rule 702 exclusion of expert witness opinion testimony.

In the context of medical causation opinions based upon epidemiologic evidence, the first obvious point is that whichever party is arguing for exclusion should distinguish between excluding an expert witness’s opinion and prohibiting an expert witness from relying upon a particular study.  Rule 702 addresses the exclusion of opinions, whereas Rule 703 addresses barring an expert witness from relying upon hearsay facts or data unless they are reasonably relied upon by experts in the appropriate field. It would be helpful for lawyers and legal academics to refrain from talking about “excluding epidemiological evidence under FRE 702.”[1] Epidemiologic studies are rarely admissible themselves, but come into the courtroom as facts and data relied upon by expert witnesses. Rule 702 is addressed to the admissibility vel non of opinion testimony, some of which may rely upon epidemiologic evidence.

Another common lawyer mistake is the over-generalization that epidemiologic research provides “gold standard” of general causation evidence.[2] Although epidemiology is often required, it not “the medical science devoted to determining the cause of disease in human beings.”[3] To be sure, epidemiologic evidence will usually be required because there is no genetic or mechanistic evidence that will support the claimed causal inference, but counsel should be cautious in stating the requirement. Glib statements by courts that epidemiology is not always required are often simply an evasion of their responsibility to evaluate the validity of the proffered expert witness opinions. A more careful phrasing of the role of epidemiology will make such glib statements more readily open to rebuttal. In the absence of direct biochemical, physiological, or genetic mechanisms that can be identified as involved in bringing about the plaintiffs’ harm, epidemiologic evidence will be required, and it may well be the “gold standard” in such cases.[4]

When epidemiologic evidence is required, counsel will usually be justified in adverting to the “hierarchy of epidemiologic evidence.” Associations are shown in studies of various designs with vastly differing degrees of validity; and of course, associations are not necessarily causal. There are thus important nuances in educating the gatekeeper about this hierarchy. First, it will often be important to educate the gatekeeper about the distinction between descriptive and analytic studies, and the inability of descriptive studies such as case reports to support causal inferences.[5]

There is then the matter of confusion within the judiciary and among “scholars” about whether a hierarchy even exists. The chapter on epidemiology in the Reference Manual on Scientific Evidence appears to suggest the specious position that there is no hierarchy.[6] The chapter on medical testimony, however, takes a different approach in identifying a normative hierarchy of evidence to be considered in evaluating causal claims.[7] The medical testimony chapter specifies that meta-analyses of randomized controlled trials sit atop the hierarchy. Yet, there are divergent opinions about what should be at the top of the hierarchical evidence pyramid. Indeed, the rigorous, large randomized trial will often replace a meta-analysis of smaller trials as the more definitive evidence.[8] Back in 2007, a dubious meta-analysis of over 40 clinical trials led to a litigation frenzy over rosiglitazone.[9] A mega-trial of rosiglitazone showed that the 2007 meta-analysis was wrong.[10]

In any event, courts must purge their beliefs that once there is “some” evidence in support of a claim, their gatekeeping role is over. Randomized controlled trials really do trump observational studies, which virtually always have actual or potential confounding in their final analyses.[11] While disclaimers about the unavailability of randomized trials for putative toxic exposures are helpful, it is not quite accurate to say that it is “unethical to intentionally expose people to a potentially harmful dose of a suspected toxin.”[12] Such trials are done all the time when there is an expected therapeutic benefit that creates at least equipoise between the overall benefit and harm at the outset of the trial.[13]

At this late date, it seems shameful that courts must be reminded that evidence of associations does not suffice to show causation, but prudence dictates giving the reminder.[14] Defense counsel will generally exhibit a Pavlovian reflex to state that causality based upon epidemiology must be viewed through a lens of “Bradford Hill criteria.”[15] Rhetorically, this reflex seems wrong given that Sir Austin himself noted that his nine different considerations were “viewpoints,” not criteria. Taking a position that requires an immediate retreat seems misguided. Similarly, urging courts to invoke and apply the Bradford Hill considerations must be accompanied the caveat that courts must first apply Bradford Hill’s predicate[16] for the nine considerations:

“Disregarding then any such problem in semantics we have this situation. Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance. What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”[17]

Courts should be mindful that the language from the famous, often-cited paper was part of an after-dinner address, in which Sir Austin was speaking informally. Scientists will understand that he was setting out a predicate that calls for

(1) an association, which is

(2) “perfectly clear cut,” such that bias and confounding are excluded, and

(3) “beyond what we would care to attribute to the play of chance,” with random error kept to an acceptable level, before advancing to further consideration of the nine viewpoints commonly recited.

These predicate findings are the basis for advancing to investigate Bradford Hill’s nine viewpoints; the viewpoints do not replace or supersede the predicates.[18]

Within the nine viewpoints, not all are of equal importance. Consistency among studies, a particularly important consideration, implies that isolated findings in a single observational study will rarely suffice to support causal conclusions. Another important consideration, the strength of the association, has nothing to do with “statistical significance,” which is a predicate consideration, but reminds us that large risk ratios or risk differences provides some evidence that the association does not result from unmeasured confounding. Eliminating confounding, however, is one of the predicate requirements for applying the nine factors. As with any methodology, the Bradford Hill factors are not self-executing. The annals of litigation provide all-too-many examples of undue selectivity, “cherry picking,” and other deviations from the scientist’s standard of care.

Certainly lawyers must steel themselves against recommending the “carcinogen” hazard identifications advanced by the International Agency for Research on Cancer (IARC). There are several problematic aspects to the methods of IARC, not the least of which is IARC’s fanciful use of the word “probable.” According to the IARC Preamble, “probable” has no quantitative meaning.[19] In common legal parlance, “probable” typically conveys a conclusion that is more likely than not. Another problem arises from the IARC’s labeling of “probable human carcinogens” made in some cases without any real evidence of carcinogenesis in humans. Regulatory pronouncements are even more diluted and often involved little more than precautionary principle wishcasting.[20]


[1] Christian W. Castile & and Stephen J. McConnell, “Excluding Epidemiological Evidence Under FRE 702,” For The Defense 18 (June 2023) [Castile]. Although these authors provide an interesting overview of the subject, they fall into some common errors, such as failing to address Rule 703. The article is worth reading for its marshaling recent case law on the subject, but I detail of its errors here in the hopes that lawyers will speak more precisely about the concepts involved in challenging medical causation opinions.

[2] Id. at 18. In re Zantac (Ranitidine) Prods. Liab. Litig., No. 2924, 2022 U.S. Dist. LEXIS 220327, at *401 (S.D. Fla. Dec. 6, 2022); see also Horwin v. Am. Home Prods., No. CV 00-04523 WJR (Ex), 2003 U.S. Dist. LEXIS 28039, at *14-15 (C.D. Cal. May 9, 2003) (“epidemiological studies provide the primary generally accepted methodology for demonstrating a causal relation between a chemical compound and a set of symptoms or disease” *** “The lack of epidemiological studies supporting Plaintiffs’ claims creates a high bar to surmount with respect to the reliability requirement, but it is not automatically fatal to their case.”).

[3] See, e.g., Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347, 1356 (N.D. Ga. 2001) (“epidemiology is the medical science devoted to determining the cause of disease in human beings”).

[4] See, e.g., Lopez v. Wyeth-Ayerst Labs., No. C 94-4054 CW, 1996 U.S. Dist. LEXIS 22739, at *1 (N.D. Cal. Dec. 13, 1996) (“Epidemiological evidence is one of the most valuable pieces of scientific evidence of causation”); Horwin v. Am. Home Prods., No. CV 00-04523 WJR (Ex), 2003 U.S. Dist. LEXIS 28039, at *15 (C.D. Cal. May 9, 2003) (“The lack of epidemiological studies supporting Plaintiffs’ claims creates a high bar to surmount with respect to the reliability requirement, but it is not automatically fatal to their case”).

[5] David A. Grimes & Kenneth F. Schulz, “Descriptive Studies: What They Can and Cannot Do,” 359 Lancet 145 (2002) (“…epidemiologists and clinicians generally use descriptive reports to search for clues of cause of disease – i.e., generation of hypotheses. In this role, descriptive studies are often a springboard into more rigorous studies with comparison groups. Common pitfalls of descriptive reports include an absence of a clear, specific, and reproducible case definition, and interpretations that overstep the data. Studies without a comparison group do not allow conclusions about cause of disease.”).

[6] Michael D. Green, D. Michal Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” Reference Manual on Scientific Evidence 549, 564n.48 (citing a paid advertisement by a group of scientists, and misleadingly referring to the publication as a National Cancer Institute symposium) (citing Michele Carbone et al., “Modern Criteria to Establish Human Cancer Etiology,” 64 Cancer Res. 5518, 5522 (2004) (National Cancer Institute symposium [sic] concluding that “[t]here should be no hierarchy [among different types of scientific methods to determine cancer causation]. Epidemiology, animal, tissue culture and molecular pathology should be seen as integrating evidences in the determination of human carcinogenicity.”).

[7] John B. Wong, Lawrence O. Gostin & Oscar A. Cabrera, “Reference Guide on Medical Testimony,” in Reference Manual on Scientific Evidence 687, 723 (3d ed. 2011).

[8] See, e.g., J.M. Elwood, Critical Appraisal of Epidemiological Studies and Clinical Trials 342 (3d ed. 2007).

[9] See Steven E. Nissen & Kathy Wolski, “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” 356 New Engl. J. Med. 2457 (2007). See also “Learning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion” (Jan. 10, 2011).

[10] Philip D. Home, et al., “Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial,” 373 Lancet 2125 (2009).

[11] In re Zantac (Ranitidine) Prods. Liab. Litig., No. 2924, 2022 U.S. Dist. LEXIS 220327, at *402 (S.D. Fla. Dec. 6, 2022) (“Unlike experimental studies in which subjects are randomly assigned to exposed and placebo groups, observational studies are subject to bias due to the possibility of differences between study populations.”)

[12] Castile at 20.

[13] See, e.g., Benjamin Freedman, “Equipoise and the ethics of clinical research,” 317 New Engl. J. Med. 141 (1987).

[14] See, e.g., In Re Onglyza (Saxagliptin) & Kombiglyze Xr (Saxagliptin & Metformin) Prods. Liab. Litig., No. 5:18-md-2809-KKC, 2022 U.S. Dist. LEXIS 136955, at *127 (E.D. Ky. Aug. 2, 2022); Burleson v. Texas Dep’t of Criminal Justice, 393 F.3d 577, 585-86 (5th Cir. 2004) (affirming exclusion of expert causation testimony based solely upon studies showing a mere correlation between defendant’s product and plaintiff’s injury); Beyer v. Anchor Insulation Co., 238 F. Supp. 3d 270, 280-81 (D. Conn. 2017); Ambrosini v. Labarraque, 101 F.3d 129, 136 (D.C. Cir. 1996).

[15] Castile at 21. See In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 26 F. Supp. 3d 449, 454-55 (E.D. Pa. 2014).

[16]Bradford Hill on Statistical Methods” (Sept. 24, 2013); see also Frank C. Woodside, III & Allison G. Davis, “The Bradford Hill Criteria: The Forgotten Predicate,” 35 Thomas Jefferson L. Rev. 103 (2013). 

[17] Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965).

[18] Castile at 21. See, e.g., In re Onglyza (Saxagliptin) & Kombiglyze XR (Saxagliptin & Metformin) Prods. Liab. Litig., No. 5:18-md-2809-KKC, 2022 U.S. Dist. LEXIS 1821, at *43 (E.D. Ky. Jan. 5, 2022) (“The analysis is meant to apply when observations reveal an association between two variables. It addresses the aspects of that association that researchers should analyze before deciding that the most likely interpretation of [the association] is causation”); Hoefling v. U.S. Smokeless Tobacco Co., LLC, 576 F. Supp. 3d 262, 273 n.4 (E.D. Pa. 2021) (“Nor would it have been appropriate to apply them here: scientists are to do so only after an epidemiological association is demonstrated”).

[19] IARC Monographs on the Identification of Carcinogenic Hazards to Humans – Preamble 31 (2019) (“The terms probably carcinogenic and possibly carcinogenic have no quantitative significance and are used as descriptors of different strengths of evidence of carcinogenicity in humans.”).

[20]Improper Reliance upon Regulatory Risk Assessments in Civil Litigation” (Mar. 19, 2023).

Tenpenny Down to Tuppence

August 22nd, 2023

Over two years ago, an osteopathic physician by the name of Sherri Tenpenny created a stir when she told the Ohio state legislature that Covid vaccines magnetize people or cause them to “interface with 5G towers.”[1] What became apparent at that time was that Tenpenny was herself a virulent disease vector of disinformation. Indeed, in its March 2021 report, the Center for Countering Digital Hate listed Tenpenny as a top anti-vaccination shyster. As a social media vector, she is ranked in the top dozen “influencers.”[2] No surprise, in addition to bloviating about Covid vaccines, someone with such quirkly non-evidence based opinions turns up in litigation as an expert witness.[3]

 

At the time of Tenpenny’s ludicrous testimony before the Ohio state legislature, one astute observer remarked that the AMA Ethical Guidelines specify that medical societies and medical licensing boards are responsible for maintaining high standards for medical testimony, and must assess “claims of false or misleading testimony.”[4] When the testimony is false or misleading, these bodies should discipline the offender “as appropriate.”[5]

The State Medical Board of Ohio stepped up to its responsibility. After receiving hundreds (roughly 350) complaints about Tenpenny’s testimony, the Ohio Board launched an investigation of Tenpenny, who was first licensed as an osteopathic physician in 1984.[6]  The Board’s investigators tried to contact Tenpenny, who apparently evaded engaging with them. Eventually, Thomas Renz, a lawyer for Tenpenny informed the Board that Tenpenny “[d]eclin[ed] to cooperate in the Board’s bad faith and unjustified assault on her licensure, livelihood, and constitutional rights cannot be construed as an admission of any allegations against her.”

After multiple unsuccessful attempts to reach Tenpenny, the Board issued a citation, in 2022, against her for stonewalling the investigation. Tenpenny requested an administrative hearing, set for April 2023, when she would be able to submit her defense in writing. The Board refused to let Tenpenny evade questioning, and suspended her license for failure to comply with the investigation. According to the Board’s Order, “Dr. Tenpenny did not simply fail to cooperate with a Board investigation, she refused to cooperate. *** And that refusal was based on her unsupported and subjective belief regarding the Board’s motive for the investigation. Licensees of the Board cannot simply refuse to cooperate in investigations because they decide they do not like what they assume is the reason for the investigation.”[7]

According to the Board’s Order, Tenpenny has been fined $3,000, and she must satisfy the Board’s conditions before applying for reinstatement. The Ohio Board’s decision is largely based upon a procedural ruling that flowed from Tenpenny’s refusal to cooperate with the Board’s investigation. Most state medical boards have done little to nothing to address the substance of physician misconduct arising out of the COVID pandemic. This month, American Board of Internal Medicine (ABIM) announced that it was revoking the board certifications of two physicians, Drs. Paul Marik and Pierre Kory, members of the Front Line COVID-19 Critical Care Alliance, for engaging in promoting disinformation and invalid opinions about therapies for COVID-19 opinions.[8] Ron Johnson, the quack senator from Wisconsin, predictably and transparently criticized the ABIM’s action with an ad hominem attack on the ABIM as the action of a corporate cabal. Quack physicians of course have a first amendment right to say whatever, but their licensure and their board certification are contingent on basic competence. Both the state boards and the certifying private groups have the right and responsibility to revoke licenses and privileges when physicians demonstrate incompetence and callousness in the face of a pandemic. There is no unqualified right to professional licenses or certifications.


[1] Andrea Salcedo, “A doctor falsely told lawmakers vaccines magnetize people: ‘They can put a key on their forehead. It sticks’,” Washington Post (June 9, 2021); Andy Downing, “What an exceedingly dumb time to be alive,” Columbus Alive (June 10, 2021); Jake Zuckerman, “She says vaccines make you magnetized. This West Chester lawmaker invited her testimony, chair says,” Ohio Capital Journal (July 14, 2021).

[2] The Disinformation Dozen (2021),

[3] Shaw v. Sec’y Health & Human Servs., No. 01-707V, 2009 U.S. Claims LEXIS 534, *84 n.40 (Fed. Cl. Spec. Mstr. Aug. 31, 2009) (excluding expert witness opinion testimony from Tenpenny).

[4]  “Epistemic Virtue – Dropping the Dime on TenpennyTortini (July 18, 2021).

[5] A.M.A. Code of Medical Ethics Opinion 9.7.1.

[6] Michael DePeau-Wilson, “Doc Who Said COVID Vax Magnetized People Has License Suspended,” MedPageToday (Aug. 11, 2023); David Gorski, “The Ohio State Medical Board has finally suspended the medical license of antivax quack Sherri Tenpenny,” Science-Based Medicine (Aug, 14, 2023).

[7] In re Sherri J. Tenpenny, D.O., Case No. 22-CRF-0168 State Medical Board of Ohio (Aug. 9, 2023).

[8] David Gorski, “The American Board of Internal Medicine finally acts against two misinformation-spreading doctors,” Science-Based Medicine (Aug. 7, 2023).

Links, Ties, and Other Hook Ups in Risk Factor Epidemiology

July 5th, 2023

Many journalists struggle with reporting the results from risk factor epidemiology. Recently, JAMA Network Open published an epidemiologic study (“Williams study”) that explored whether exposure to Agent Orange amoby ng United States military veterans was associated with bladder cancer.[1] The reported study found little to no association, but lay and scientific journalists described the study as finding a “link,”[2] or a “tie,”[3] thus suggesting causality. One web-based media report stated, without qualification, that Agent Orange “increases bladder cancer risk.”[4]

 

Even the authors of the Williams study described the results inconsistently and hyperbolically. Within the four corners of the published article, the authors described their having found a “modestly increased risk of bladder cancer,” and then, on the same page, they reported that “the association was very slight (hazard ratio, 1.04; 95% C.I.,1.02-1.06).”

In one place, the Williams study states it looked at a cohort of 868,912 veterans with exposure to Agent Orange, and evaluated bladder cancer outcomes against outcomes in 2,427,677 matched controls. Elsewhere, they report different numbers, which are hard to reconcile. In any event, the authors had a very large sample size, which had the power to detect theoretically small differences as “statistically significant” (p < 0.05). Indeed, the study was so large that even a very slight disparity in rates between the exposed and unexposed cohort members could be “statistically significantly” different, notwithstanding that systematic error certainly played a much larger role in the results than random error. In terms of absolute numbers, the researchers found 50,781 bladder cancer diagnoses, on follow-up of 28,672,655 person-years. There were overall 2.1% bladder cancers among the exposed servicemen, and 2.0% among the unexposed. Calling this putative disparity a “modest association” is a gross overstatement, and it is difficult to square the authors’ pronouncement of a “modest association” with a “very slight increased risk.”

The authors also reported that there was no association between Agent Orange exposure and aggressiveness of bladder cancer, with bladder wall muscle invasion taken to be the marker of aggressiveness. Given that the authors were willing to proclaim a hazard ratio of 1.04 as an association, this report of no association with aggressiveness is manifestly false. The Williams study found a decreased odds of a diagnosis of muscle-invasive bladder cancer among the exposed cases, with an odds ratio of 0.91, 95% CI 0.85-0.98 (p = 0.009). The study thus did not find an absence of an association, but rather an inverse association.

Causality

Under the heading of “Meaning,” the authors wrote that “[t]hese findings suggest an association between exposure to Agent Orange and bladder cancer, although the clinical relevance of this was unclear.” Despite disclaiming a causal interpretation of their results, Williams and colleagues wrote that their results “support prior investigations and further support bladder cancer to be designated as an Agent Orange-associated disease.”

Williams and colleagues note that the Institute of Medicine had suggested that the association between Agent Orange exposure and bladder cancer outcomes required further research.[5] Requiring additional research was apparently sufficient for the Department of Veterans Affairs, in 2021, to assume facts not in evidence, and to designate “bladder cancer as a cancer caused by Agent Orange exposure.”[6]

Williams and colleagues themselves appear to disavow a causal interpretation of their results: “we cannot determine causality given the retrospective nature of our study design.” They also acknowledged their inability to “exclude potential selection bias and misclassification bias.” Although the authors did not explore the issue, exposed servicemen may well have been under greater scrutiny, creating surveillance and diagnostic biases.

The authors failed to grapple with other, perhaps more serious biases and inadequacy of methodology in their study. Although the authors claimed to have controlled for the most important confounders, they failed to include diabetes as a co-variate in their analysis, even though diabetic patients have a more than doubled increased risk for bladder cancer, even after adjustment for smoking.[7] Diabetic patients would also have been likely to have had more visits to VA centers for healthcare and more opportunity to have been diagnosed with bladder cancer.

Futhermore, with respect to the known confounding variable of smoking, the authors trichotomized smoking history as “never,” “former,” or “current” smoker. The authors were missing smoking information in about 13% of the cohort. In a univariate analysis based upon smoking status (Table 4), the authors reported the following hazard ratios for bladder cancer, by smoking status:

Smoking status at bladder cancer diagnosis

Never smoked      1   [Reference]

Current smoker   1.10 (1.00-1.21)

Former smoker    1.08 (1.00-1.18)

Unknown              1.17 (1.05-1.31)

This analysis for smoking risk points to the fragility of the Agent Orange analyses. First, the “unknown” smoking status is associated with roughly twice the risk for current or former smokers. Second, the risk ratios for muscle-invasive bladder cancer were understandably higher for current smokers (OR 1.10, 95% CI 1.00-1.21) and former smokers (OR 1.08, 95% CI 1.00-1.18) than for non-smoking veterans.

Third, the Williams’ study’s univariate analysis of smoking and bladder cancer generates risk ratios that are quite out of line with independent studies of smoking and bladder cancer risk. For instance, meta-analyses of studies of smoking and bladder cancer risk report risk ratios of 2.58 (95% C.I., 2.37–2.80) for any smoking, 3.47 (3.07–3.91) for current smoking, and 2.04 (1.85–2.25) for past smoking.[8] These smoking-related bladder cancer risks are thus order(s) of magnitude greater than the univariate analysis of smoking risk in the Williams study, as well as the multivariate analysis of Agent Orange risk reported.

Fourth, the authors engage in the common, but questionable practice of categorizing a known confounder, smoking, which should ideally be reported as a continuous variable with respect to quantity consumed, years smoked, and years since quitting.[9] The question here, given that the study is very large, is not the loss of power,[10] but bias away from the null. Peter Austin has shown, by Monte Carlo simulation, that categorizing a continuous variable in a logistic regression results in inflating the rate of finding false positive associations.[11] The type I (false-positive) error rates increases with sample size, with increasing correlation between the confounding variable and outcome of interest, and the number of categories used for the continuous variables. The large dataset used by Williams and colleagues, which they see as a plus, works against them by increasing the bias from the use of categorical variables for confounding variables.[12]

The Williams study raises serious questions not only about the quality of medical journalism, but also about how an executive agency such as the Veterans Administration evaluates scientific evidence. If the Williams study were to play a role in compensation determinations, it would seem that veterans with muscle-invasive bladder cancer would be turned away, while those veterans with less serious cancers would be compensated. But with 2.1% incidence versus 2.0%, how can compensation be rationally permitted in every case?


[1] Stephen B. Williams, Jessica L. Janes, Lauren E. Howard, Ruixin Yang, Amanda M. De Hoedt, Jacques G. Baillargeon, Yong-Fang Kuo, Douglas S. Tyler, Martha K. Terris, Stephen J. Freedland, “Exposure to Agent Orange and Risk of Bladder Cancer Among US Veterans,” 6 JAMA Network Open e2320593 (2023).

[2] Elana Gotkine, “Exposure to Agent Orange Linked to Risk of Bladder Cancer,” Buffalo News (June 28, 2023); Drew Amorosi, “Agent Orange exposure linked to increased risk for bladder cancer among Vietnam veterans,” HemOnc Today (June 27, 2023).

[3] Andrea S. Blevins Primeau, “Agent Orange Exposure Tied to Increased Risk of Bladder Cancer,” Cancer Therapy Advisor (June 30, 2023); Mike Bassett, “Agent Orange Exposure Tied to Bladder Cancer Risk in Veterans — Increased risk described as ‘modest’, and no association seen with aggressiveness of cancer,” Medpage Today (June 27, 2023).

[4] Darlene Dobkowski, “Agent Orange Exposure Modestly Increases Bladder Cancer Risk in Vietnam Veterans,” Cure Today (June 27, 2023).

[5] Institute of Medicine – Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides (Tenth Biennial Update), Veterans and Agent Orange: Update 2014 at 10 (2016) (upgrading previous finding of “inadequate” to “suggestive”).

[6] Williams study, citing U.S. Department of Veterans Affairs, “Agent Orange exposure and VA disability compensation.”

[7] Yeung Ng, I. Husain, N. Waterfall, “Diabetes Mellitus and Bladder Cancer – An Epidemiological Relationship?” 9 Path. Oncol. Research 30 (2003) (diabetic patients had an increased, significant odds ratio for bladder cancer compared with non diabetics even after adjustment for smoking and age [OR: 2.69 p=0.049 (95% CI 1.006-7.194)]).

[8] Marcus G. Cumberbatch, Matteo Rota, James W.F. Catto, and Carlo La Vecchia, “The Role of Tobacco Smoke in Bladder and Kidney Carcinogenesis: A Comparison of Exposures and Meta-analysis of Incidence and Mortality Risks?” 70 European Urology 458 (2016).

[9] See generally, “Confounded by Confounding in Unexpected Places” (Dec. 12, 2021).

[10] Jacob Cohen, “The cost of dichotomization,” 7 Applied Psychol. Measurement 249 (1983).

[11] Peter C. Austin & Lawrence J. Brunner, “Inflation of the type I error rate when a continuous confounding variable is categorized in logistic regression analyses,” 23 Statist. Med. 1159 (2004).

[12] See, e.g., Douglas G. Altman & Patrick Royston, “The cost of dichotomising continuous variables,” 332 Brit. Med. J. 1080 (2006); Patrick Royston, Douglas G. Altman, and Willi Sauerbrei, “Dichotomizing continuous predictors in multiple regression: a bad idea,” 25 Stat. Med. 127 (2006); Valerii Fedorov, Frank Mannino, and Rongmei Zhang, “Consequences of dichotomization,” 8 Pharmaceut. Statist. 50 (2009). See also Robert C. MacCallum, Shaobo Zhang, Kristopher J. Preacher, and Derek D. Rucker, “On the Practice of Dichotomization of Quantitative Variables,” 7 Psychological Methods 19 (2002); David L. Streiner, “Breaking Up is Hard to Do: The Heartbreak of Dichotomizing Continuous Data,” 47 Can. J. Psychiatry 262 (2002); Henian Chen, Patricia Cohen, and Sophie Chen, “Biased odds ratios from dichotomization of age,” 26 Statist. Med. 3487 (2007); Carl van Walraven & Robert G. Hart, “Leave ‘em Alone – Why Continuous Variables Should Be Analyzed as Such,” 30 Neuroepidemiology 138 (2008); O. Naggara, J. Raymond, F. Guilbert, D. Roy, A. Weill, and Douglas G. Altman, “Analysis by Categorizing or Dichotomizing Continuous Variables Is Inadvisable,” 32 Am. J. Neuroradiol. 437 (Mar 2011); Neal V. Dawson & Robert Weiss, “Dichotomizing Continuous Variables in Statistical Analysis: A Practice to Avoid,” Med. Decision Making 225 (2012); Phillippa M. Cumberland, Gabriela Czanner, Catey Bunce, Caroline J. Doré, Nick Freemantle, and Marta García-Fiñana, “Ophthalmic statistics note: the perils of dichotomising continuous variables,” 98 Brit. J. Ophthalmol. 841 (2014); Julie R. Irwin & Gary H. McClelland, “Negative Consequences of Dichotomizing Continuous Predictor Variables,” 40 J. Marketing Research 366 (2003); Stanley E. Lazic, “Four simple ways to increase power without increasing the sample size,” PeerJ Preprints (23 Oct 2017).

Is the Scientific Method Fascist?

June 14th, 2023

Just before the pandemic, when our country seems to have gone tits up, there was a studied effort to equate any emphasis on scientific method, and the valuation of “[o]bjective, rational linear thinking; “[c]ause and effect relationships”; and “[q]uantitative emphasis,” with white privilege and microaggression against non-white people.

I am not making up this claim; I am not creative enough. Indeed, for a while, the  Smithsonian National Museum of African American History & Culture featured a graphic that included “emphasis on scientific method” as aspect of white culture, and implied it was an unsavory aspect of “white privilege.”[1]

Well, as it turns out, scientific method is not only racist, but fascist as well.

With pretentious citations to Deleuze,[2] Foucault,[3] and Lyotard,[4] a group of Canadian authors[5] set out to decolonize science and medicine from the fascist grip of scientific methodology and organizations such as the Cochrane Group. The grand insight is that the health sciences have been “colonized” by a scientific research “paradigm” that is “outrageously exclusionary and dangerously normative with regards to scientific knowledge.” By excluding “alternative forms of knowledge,” evidence-based medicine acts as a “fascist structure.” The Cochcrane Group in particular is singled out for having created an exclusionary and non-egalitarian hierarchy of evidence.  Intolerance for non-approved modes of inference and thinking are, in these authors’ view, “manifestations of fascism,” which are more “pernicious,” even if less brutal than the fascism practiced by Hitler and Mussolini.[6]

Clutch the pearls!

Never mind that “deconstruction” itself sounds a bit fascoid,[7] not to mention a rather vague concept. The authors seem intent to promote multiple ways of knowing without epistemic content. Indeed, our antifa authors do not attempt to show that evidence-based medicine leads regularly to incorrect results, or that their unspecified alternatives have greater predictive value. Nonetheless, decolonization of medicine and deconstruction of hierarchical methodology remain key for them to achieve an egalitarian epistemology, by which everyone is equally informed and equally stupid. In the inimitable words of the authors, “many scientists find themselves interpellated by hegemonic discourses and come to disregard all others.”[8]

These epistemic freedom fighters want to divorce the idea of evidence from objective reality, and make evidence bend to “values.”[9] Apparently, the required deconstruction of the “knowing subject” is that the subject is “implicitly implicitly male, white, Western and heterosexual.” Medicine’s fixation on binaries such as normal and pathological, male and female, shows that evidence-based medicine is simply not queer enough. Our intrepid authors must be credited for having outed the “hidden political agenda” of those who pretend simply to find the truth, but who salivate over imposing their “hegemonic norms,” asserted in the “name of ‘truth’.”

These Canadian authors leave us with a battle cry: “scholars have not only a scientific duty, but also an ethical obligation to deconstruct these regimes of power.”[10] Scientists of the world, you have nothing to lose but your socially constructed non-sensical conception of scientific truth.

Although it is easy to make fun of post-modernist pretensions,[11] there is a point about the force of argument and evidence. The word “valid” comes to us from the 16th century French word “valide,” which in turn comes from the Latin validus, meaning strong. Similarly, we describe a well-conducted study with robust findings as compelling our belief.

I recall the late Robert Nozick, back in the 1970s, expressing the view that someone who embraced a contradiction might pop out of existence, the way an electron and a positron might cancel each other. If only it were so, we might have people exercising more care in their thinking and speaking.


[1]Is Your Daubert Motion Racist?” (July 17, 2020). The Smithsonian has since seen fit to remove the chart reproduced here, but we know what they really believe.

[2] Gilles Deleuze and Félix Guattari, Anti-oedipus: Capitalism and Schizophrenia (1980); Gilles Deleuze and Félix Guattari, A Thousand Plateaus: Capitalism and Schizophrenia (1987). This dross enjoyed funding from the Canadian Institutes of Health Research, and the Social Science and Humanities Research Council of Canada.

[3] Michel Foucault, The Birth of the Clinic: An Archaeology of Medical Perception (1973); Michel Foucault, The History of Sexuality, Volume 1: An Introduction (trans. Robert Hurley 1978); Michel Foucault, Society Must Be Defended: Lectures at the Collège de France, 1975–1976 (2003); Michel Foucault, Power/Knowledge: Selected Interviews and Other Writings, 1972–1977 (1980); Michel Foucault, Fearless Speech (2001).

[4] Jean-François Lyotard, The Postmodern Condition: A Report on Knowledge (1984).

[5] Dave Holmes, Stuart J Murray, Amélie Perron, and Geneviève Rail, “Deconstructing the evidence-based discourse in health sciences: truth, power and fascism,” 4 Internat’l J. Evidence-Based Health 180 (2006) [Deconstructing]

[6][6] Deconstructing at 181.

[7] Pace David Frum

[8] Deconstructing at 182.

[9] Deconstructing at 183.

[10] Deconstructing  at 180-81.

[11] Alan D. Sokal, “Transgressing the Boundaries: Toward a Transformative Hermeneutics of Quantum Gravity,” 46 Social Text 217 (1994).

Judicial Flotsam & Jetsam – Retractions

June 12th, 2023

In scientific publishing, when scientists make a mistake, they publish an erratum or a corrigendum. If the mistake vitiates the study, then the erring scientists retract their article. To be sure, sometimes the retraction comes after an obscene delay, with the authors kicking and screaming.[1] Sometimes the retraction comes at the request of the authors, better late than never.[2]

Retractions in the biomedical journals, whether voluntary or not, are on the rise.[3] The process and procedures for retraction of articles often lack transparency. Many articles are retracted without explanation or disclosure of specific problems about the data or the analysis.[4] Sadly, however, misconduct in the form of plagiarism and data falsification is a frequent reason for retractions.[5] The lack of transparency for retractions, and sloppy scholarship, combine to create Zombie papers, which are retracted but continue to be cited in subsequent publications.[6]

LEGAL RETRACTIONS

The law treats errors very differently. Being a judge usually means that you never have to say you are sorry. Judge Andrew Hurwitz has argued that that our legal system would be better served if judges could and did “freely acknowledged and transparently corrected the occasional ‘goof’.”[7] Alas, as Judge Hurwitz notes, very few published decisions acknowledge mistakes.[8]

In the world of scientific jurisprudence, the judicial reticence to acknowledge mistakes is particularly dangerous, and it leads directly to the proliferation of citations to cases that make egregious mistakes. In the niche area of judicial assessment of scientific and statistical evidence, the proliferation of erroneous statements is especially harmful because it interferes with thinking clearly about the issues before courts. Judges believe that they have argued persuasively for a result, not by correctly marshaling statistical and scientific concepts, but by relying upon precedents erroneously arrived at by other judges in earlier cases. Regardless of how many cases are cited (and there are many possible “precedents”), the true parameter does not have a 95% probability of lying within the interval given by a given 95% confidence interval.[9] Similarly, as much as judges would like p-values and confidence intervals to eliminate the need to worry about systematic error, their saying so cannot make it so.[10] Even a mighty federal judge cannot make the p-value probability, or its complement, substitute for the posterior probability of a causal claim.[11]

Some cases in the books are so egregiously decided that it is truly remarkable that they would be cited for any proposition. I call these scientific Dred Scott cases, which illustrate that sometimes science has no criteria of validity that the law is bound to respect. One such Dred Scott case was the result of a bench trial in a federal district court in Atlanta, in Wells v. Ortho Pharmaceutical Corporation.[12]

Wells was notorious for its poor assessment of all the determinants of scientific causation.[13] The decision was met with a storm of opprobrium from the legal and medical community.[14] No scientists or legal scholars offered a serious defense of Wells on the scientific merits. Even the notorious plaintiffs’ expert witness, Carl Cranor, could muster only a distanced agnosticism:

“In Wells v. Ortho Pharmaceutical Corp., which involved a claim that birth defects were caused by a spermicidal jelly, the U.S. Court of Appeals for the 11th Circuit followed the principles of Ferebee and affirmed a plaintiff’s verdict for about five million dollars. However, some members of the medical community chastised the legal system essentially for ignoring a well-established scientific consensus that spermicides are not teratogenic. We are not in a position to judge this particular issue, but the possibility of such results exists.”[15]

Cranor apparently could not bring himself to note that it was not just scientific consensus that was ignored; the Wells case ignored the basic scientific process of examining relevant studies for both internal and external validity.

Notwithstanding this scholarly consensus and condemnation, we have witnessed the repeated recrudescence of the Wells decision. In Matrixx Initiatives, Inc. v. Siracusano,[16] in 2011, the Supreme Court, speaking through Justice Sotomayor, wandered into a discussion, irrelevant to its holding, whether statistical significance was necessary for a determination of the causality of an association:

“We note that courts frequently permit expert testimony on causation based on evidence other than statistical significance. Seee.g.Best v. Lowe’s Home Centers, Inc., 563 F. 3d 171, 178 (6th Cir 2009); Westberry v. Gislaved Gummi AB, 178 F. 3d 257, 263–264 (4th Cir. 1999) (citing cases); Wells v. Ortho Pharmaceutical Corp., 788 F. 2d 741, 744–745 (11th Cir. 1986). We need not consider whether the expert testimony was properly admitted in those cases, and we do not attempt to define here what constitutes reliable evidence of causation.”[17]

The quoted language is remarkable for two reasons. First, the Best and Westberry cases did not involve statistics at all. They addressed specific causation inferences from what is generally known as differential etiology. Second, the citation to Wells was noteworthy because the case has nothing to do with adverse event reports or the lack of statistical significance.

Wells involved a claim of birth defects caused by the use of spermicidal jelly contraceptive, which had been the subject of several studies, one of which at least yielded a nominally statistically significant increase in detected birth defects over what was expected.

Wells could thus hardly be an example of a case in which there was a judgment of causation based upon a scientific study that lacked statistical significance in its findings. Of course, finding statistical significance is just the beginning of assessing the causality of an association. The most remarkable and disturbing aspect of the citation to Wells, however, was that the Court was unaware of, or ignored, the case’s notoriety, and the scholarly and scientific consensus that criticized the decision for its failure to evaluate the entire evidentiary display, as well as for its failure to rule out bias and confounding in the studies relied upon by the plaintiff.

Justice Sotomayor’s decision for a unanimous Court is not alone in its failure of scholarship and analysis in embracing the dubious precedent of Wells. Many other courts have done much the same, both in state[18] and in federal courts,[19] and both before and after the Supreme Court decided Daubert, and even after Rule 702 was amended in 2000.[20] Perhaps even more disturbing is that the current edition of the Reference Manual on Scientific Evidence glibly cites to the Wells case, for the dubious proposition that

“Generally, researchers are conservative when it comes to assessing causal relationships, often calling for stronger evidence and more research before a conclusion of causation is drawn.”[21]

We are coming up on the 40th anniversary of the Wells judgment. It is long past time to stop citing the case. Perhaps we have reached the stage of dealing with scientific evidence at which errant and aberrant cases should be retracted, and clearly marked as retracted in the official reporters, and in the electronic legal databases. Certainly the technology exists to link the scholarly criticism with a case citation, just as we link subsequent judicial treatment by overruling, limiting, and criticizing.


[1] Laura Eggertson, “Lancet retracts 12-year-old article linking autism to MMR vaccines,” 182 Canadian Med. Ass’n J. E199 (2010).

[2] Notice of retraction for Teng Zeng & William Mitch, “Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine,” 37 Carcinogenesis 625 (2016), published online (May 4, 2021) (retraction requested by authors with an acknowledgement that they had used incorrect analytical methods for their study).

[3] Tianwei He, “Retraction of global scientific publications from 2001 to 2010,” 96 Scientometrics 555 (2013); Bhumika Bhatt, “A multi-perspective analysis of retractions in life sciences,” 126 Scientometrics 4039 (2021); Raoul R.Wadhwa, Chandruganesh Rasendran, Zoran B. Popovic, Steven E. Nissen, and Milind Y. Desai, “Temporal Trends, Characteristics, and Citations of Retracted Articles in Cardiovascular Medicine,” 4 JAMA Network Open e2118263 (2021); Mario Gaudino, N. Bryce Robinson, Katia Audisio, Mohamed Rahouma, Umberto Benedetto, Paul Kurlansky, Stephen E. Fremes, “Trends and Characteristics of Retracted Articles in the Biomedical Literature, 1971 to 2020,” 181 J. Am. Med. Ass’n Internal Med. 1118 (2021); Nicole Shu Ling Yeo-Teh & Bor Luen Tang, “Sustained Rise in Retractions in the Life Sciences Literature during the Pandemic Years 2020 and 2021,” 10 Publications 29 (2022).

[4] Elizabeth Wager & Peter Williams, “Why and how do journals retract articles? An analysis of Medline retractions 1988-2008,” 37 J. Med. Ethics 567 (2011).

[5] Ferric C. Fanga, R. Grant Steen, and Arturo Casadevall, “Misconduct accounts for the majority of retracted scientific publications,” 109 Proc. Nat’l Acad. Sci. 17028 (2012); L.M. Chambers, C.M. Michener, and T. Falcone, “Plagiarism and data falsification are the most common reasons for retracted publications in obstetrics and gynaecology,” 126 Br. J. Obstetrics & Gyn. 1134 (2019); M.S. Marsh, “Separating the good guys and gals from the bad,” 126 Br. J. Obstetrics & Gyn. 1140 (2019).

[6] Tzu-Kun Hsiao and Jodi Schneider, “Continued use of retracted papers: Temporal trends in citations and (lack of) awareness of retractions shown in citation contexts in biomedicine,” 2 Quantitative Science Studies 1144 (2021).

[7] Andrew D. Hurwitz, “When Judges Err: Is Confession Good for the Soul?” 56 Ariz. L. Rev. 343, 343 (2014).

[8] See id. at 343-44 (quoting Justice Story who dealt with the need to contradict a previously published opinion, and who wrote “[m]y own error, however, can furnish no ground for its being adopted by this Court.” U.S. v. Gooding, 25 U.S. 460, 478 (1827)).

[9] See, e.g., DeLuca v. Merrell Dow Pharms., Inc., 791 F. Supp. 1042, 1046 (D.N.J. 1992) (”A 95% confidence interval means that there is a 95% probability that the ‘true’ relative risk falls within the interval”) , aff’d, 6 F.3d 778 (3d Cir. 1993); In re Silicone Gel Breast Implants Prods. Liab. Litig, 318 F.Supp.2d 879, 897 (C.D. Cal. 2004); Eli Lilly & Co. v. Teva Pharms, USA, 2008 WL 2410420, *24 (S.D.Ind. 2008) (stating incorrectly that “95% percent of the time, the true mean value will be contained within the lower and upper limits of the confidence interval range”). See also Confidence in Intervals and Diffidence in the Courts” (Mar. 4, 2012).

[10] See, e.g., Brock v. Merrill Dow Pharmaceuticals, Inc., 874 F.2d 307, 311-12 (5th Cir. 1989) (“Fortunately, we do not have to resolve any of the above questions [as to bias and confounding], since the studies presented to us incorporate the possibility of these factors by the use of a confidence interval.”). This howler has been widely acknowledged in the scholarly literature. See David Kaye, David Bernstein, and Jennifer Mnookin, The New Wigmore – A Treatise on Evidence: Expert Evidence § 12.6.4, at 546 (2d ed. 2011); Michael O. Finkelstein, Basic Concepts of Probability and Statistics in the Law 86-87 (2009) (criticizing the blatantly incorrect interpretation of confidence intervals by the Brock court).

[11] In re Ephedra Prods. Liab. Litig., 393 F.Supp. 2d 181, 191 (S.D.N.Y. 2005) (Rakoff, J.) (“Generally accepted scientific convention treats a result as statistically significant if the P-value is not greater than .05. The expression ‘P=.05’ means that there is one chance in twenty that a result showing increased risk was caused by a sampling error — i.e., that the randomly selected sample accidentally turned out to be so unrepresentative that it falsely indicates an elevated risk.”); see also In re Phenylpropanolamine (PPA) Prods. Liab. Litig., 289 F.Supp. 2d 1230, 1236 n.1 (W.D. Wash. 2003) (“P-values measure the probability that the reported association was due to chance… .”). Although the erroneous Ephedra opinion continues to be cited, it has been debunked in the scholarly literature. See Michael O. Finkelstein, Basic Concepts of Probability and Statistics in the Law 65 (2009); Nathan A. Schachtman, “Statistical Evidence in Products Liability Litigation,” at 28-13, chap. 28, in Stephanie A. Scharf, George D. Sax, & Sarah R. Marmor, eds., Product Liability Litigation: Current Law, Strategies and Best Practices (2d ed. 2021).

[12] Wells v. Ortho Pharm. Corp., 615 F. Supp. 262 (N.D. Ga.1985), aff’d & modified in part, remanded, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S. 950 (1986).

[13] I have discussed the Wells case in a series of posts, “Wells v. Ortho Pharm. Corp., Reconsidered,” (2012), part one, two, three, four, five, and six.

[14] See, e.g., James L. Mills and Duane Alexander, “Teratogens and ‘Litogens’,” 15 New Engl. J. Med. 1234 (1986); Samuel R. Gross, “Expert Evidence,” 1991 Wis. L. Rev. 1113, 1121-24 (1991) (“Unfortunately, Judge Shoob’s decision is absolutely wrong. There is no scientifically credible evidence that Ortho-Gynol Contraceptive Jelly ever causes birth defects.”). See also Editorial, “Federal Judges v. Science,” N.Y. Times, December 27, 1986, at A22 (unsigned editorial) (“That Judge Shoob and the appellate judges ignored the best scientific evidence is an intellectual embarrassment.”);  David E. Bernstein, “Junk Science in the Courtroom,” Wall St. J. at A 15 (Mar. 24,1993) (pointing to Wells as a prominent example of how the federal judiciary had embarrassed American judicial system with its careless, non-evidence based approach to scientific evidence); Bert Black, Francisco J. Ayala & Carol Saffran-Brinks, “Science and the Law in the Wake of Daubert: A New Search for Scientific Knowledge,” 72 Texas L. Rev. 715, 733-34 (1994) (lawyers and leading scientist noting that the district judge “found that the scientific studies relied upon by the plaintiffs’ expert were inconclusive, but nonetheless held his testimony sufficient to support a plaintiffs’ verdict. *** [T]he court explicitly based its decision on the demeanor, tone, motives, biases, and interests that might have influenced each expert’s opinion. Scientific validity apparently did not matter at all.”) (internal citations omitted); Bert Black, “A Unified Theory of Scientific Evidence,” 56 Fordham L. Rev. 595, 672-74 (1988); Paul F. Strain & Bert Black, “Dare We Trust the Jury – No,” 18 Brief  7 (1988); Bert Black, “Evolving Legal Standards for the Admissibility of Scientific Evidence,” 239 Science 1508, 1511 (1988); Diana K. Sheiness, “Out of the Twilight Zone: The Implications of Daubert v. Merrill Dow Pharmaceuticals, Inc.,” 69 Wash. L. Rev. 481, 493 (1994); David E. Bernstein, “The Admissibility of Scientific Evidence after Daubert v. Merrell Dow Pharmacueticals, Inc.,” 15 Cardozo L. Rev. 2139, 2140 (1993) (embarrassing decision); Troyen A. Brennan, “Untangling Causation Issues in Law and Medicine: Hazardous Substance Litigation,” 107 Ann. Intern. Med. 741, 744-45 (1987) (describing the result in Wells as arising from the difficulties created by the Ferebee case; “[t]he Wells case can be characterized as the court embracing the hypothesis when the epidemiologic study fails to show any effect”); Troyen A. Brennan, “Causal Chains and Statistical Links: Some Thoughts on the Role of Scientific Uncertainty in Hazardous Substance Litigation,” 73 Cornell L. Rev. 469, 496-500 (1988); David B. Brushwood, “Drug induced birth defects: difficult decisions and shared responsibilities,” 91 W. Va. L. Rev. 51, 74 (1988); Kenneth R. Foster, David E. Bernstein, and Peter W. Huber, eds., Phantom Risk: Scientific Inference and the Law 28-29, 138-39 (1993) (criticizing Wells decision); Peter Huber, “Medical Experts and the Ghost of Galileo,” 54 Law & Contemp. Problems 119, 158 (1991); Edward W. Kirsch, “Daubert v. Merrell Dow Pharmaceuticals: Active Judicial Scrutiny of Scientific Evidence,” 50 Food & Drug L.J. 213 (1995) (“a case in which a court completely ignored the overwhelming consensus of the scientific community”); Hans Zeisel & David Kaye, Prove It With Figures: Empirical Methods in Law and Litigation § 6.5, at 93(1997) (noting the multiple comparisons in studies of birth defects among women who used spermicides, based upon the many reported categories of birth malformations, and the large potential for even more unreported categories); id. at § 6.5 n.3, at 271 (characterizing Wells as “notorious,” and noting that the case became a “lightning rod for the legal system’s ability to handle expert evidence.”); Edward K. Cheng , “Independent Judicial Research in the ‘Daubert’ Age,” 56 Duke L. J. 1263 (2007) (“notoriously concluded”); Edward K. Cheng, “Same Old, Same Old: Scientific Evidence Past and Present,” 104 Michigan L. Rev. 1387, 1391 (2006) (“judge was fooled”); Harold P. Green, “The Law-Science Interface in Public Policy Decisionmaking,” 51 Ohio St. L.J. 375, 390 (1990); Stephen L. Isaacs & Renee Holt, “Drug regulation, product liability, and the contraceptive crunch: Choices are dwindling,” 8 J. Legal Med. 533 (1987); Neil Vidmar & Shari S. Diamond, “Juries and Expert Evidence,” 66 Brook. L. Rev. 1121, 1169-1170 (2001); Adil E. Shamoo, “Scientific evidence and the judicial system,” 4 Accountability in Research 21, 27 (1995); Michael S. Davidson, “The limitations of scientific testimony in chronic disease litigation,” 10 J. Am. Coll. Toxicol. 431, 435 (1991); Charles R. Nesson & Yochai Benkler, “Constitutional Hearsay: Requiring Foundational Testing and Corroboration under the Confrontation Clause,” 81 Virginia L. Rev. 149, 155 (1995); Stephen D. Sugarman, “The Need to Reform Personal Injury Law Leaving Scientific Disputes to Scientists,” 248 Science 823, 824 (1990); Jay P. Kesan, “A Critical Examination of the Post-Daubert Scientific Evidence Landscape,” 52 Food & Drug L. J. 225, 225 (1997); Ora Fred Harris, Jr., “Communicating the Hazards of Toxic Substance Exposure,” 39 J. Legal Ed. 97, 99 (1989) (“some seemingly horrendous decisions”); Ora Fred Harris, Jr., “Complex Product Design Litigation: A Need for More Capable Fact-Finders,” 79 Kentucky L. J. 510 & n.194 (1991) (“uninformed judicial decision”); Barry L. Shapiro & Marc S. Klein, “Epidemiology in the Courtroom: Anatomy of an Intellectual Embarrassment,” in Stanley A. Edlavitch, ed., Pharmacoepidemiology 87 (1989); Marc S. Klein, “Expert Testimony in Pharmaceutical Product Liability Actions,” 45 Food, Drug, Cosmetic L. J. 393, 410 (1990); Michael S. Lehv, “Medical Product Liability,” Ch. 39, in Sandy M. Sanbar & Marvin H. Firestone, eds., Legal Medicine 397, 397 (7th ed. 2007); R. Ryan Stoll, “A Question of Competence – Judicial Role in Regulation of Pharmaceuticals,” 45 Food, Drug, Cosmetic L. J. 279, 287 (1990); Note, “A Question of Competence: The Judicial Role in the Regulation of Pharmaceuticals,” Harvard L. Rev. 773, 781 (1990); Peter H. Schuck, “Multi-Culturalism Redux: Science, Law, and Politics,” 11 Yale L. & Policy Rev. 1, 13 (1993); Howard A. Denemark, “Improving Litigation Against Drug Manufacturers for Failure to Warn Against Possible Side  Effects: Keeping Dubious Lawsuits from Driving Good Drugs off the Market,” 40 Case Western Reserve L.  Rev. 413, 438-50 (1989-90); Howard A. Denemark, “The Search for Scientific Knowledge in Federal Courts in the Post-Frye Era: Refuting the Assertion that Law Seeks Justice While Science Seeks Truth,” 8 High Technology L. J. 235 (1993)

[15] Carl Cranor & Kurt Nutting, “Scientific and Legal Standards of Statistical Evidence in Toxic Tort and Discrimination Suits,” 9 Law & Philosophy 115, 123 (1990) (internal citations omitted).

[16] 131 S.Ct. 1309 (2011) [Matrixx]

[17] Id. at 1319.

[18] Baroldy v. Ortho Pharmaceutical Corp., 157 Ariz. 574, 583, 760 P.2d 574 (Ct. App. 1988); Earl v. Cryovac, A Div. of WR Grace, 115 Idaho 1087, 772 P. 2d 725, 733 (Ct. App. 1989); Rubanick v. Witco Chemical Corp., 242 N.J. Super. 36, 54, 576 A. 2d 4 (App. Div. 1990), aff’d in part, 125 N.J. 421, 442, 593 A. 2d 733 (1991); Minnesota Min. & Mfg. Co. v. Atterbury, 978 S.W. 2d 183, 193 n.7 (Tex. App. 1998); E.I. Dupont de Nemours v. Castillo ex rel. Castillo, 748 So. 2d 1108, 1120 (Fla. Dist. Ct. App. 2000); Bell v. Lollar, 791 N.E.2d 849, 854 (Ind. App. 2003; King v. Burlington Northern & Santa Fe Ry, 277 Neb. 203, 762 N.W.2d 24, 35 & n.16 (2009).

[19] City of Greenville v. WR Grace & Co., 827 F. 2d 975, 984 (4th Cir. 1987); American Home Products Corp. v. Johnson & Johnson, 672 F. Supp. 135, 142 (S.D.N.Y. 1987); Longmore v. Merrell Dow Pharms., Inc., 737 F. Supp. 1117, 1119 (D. Idaho 1990); Conde v. Velsicol Chemical Corp., 804 F. Supp. 972, 1019 (S.D. Ohio 1992); Joiner v. General Elec. Co., 864 F. Supp. 1310, 1322 (N.D. Ga. 1994) (which case ultimately ended up in the Supreme Court); Bowers v. Northern Telecom, Inc., 905 F. Supp. 1004, 1010 (N.D. Fla. 1995); Pick v. American Medical Systems, 958 F. Supp. 1151, 1158 (E.D. La. 1997); Baker v. Danek Medical, 35 F. Supp. 2d 875, 880 (N.D. Fla. 1998).

[20] Rider v. Sandoz Pharms. Corp., 295 F. 3d 1194, 1199 (11th Cir. 2002); Kilpatrick v. Breg, Inc., 613 F. 3d 1329, 1337 (11th Cir. 2010); Siharath v. Sandoz Pharms. Corp., 131 F. Supp. 2d 1347, 1359 (N.D. Ga. 2001); In re Meridia Prods. Liab. Litig., Case No. 5:02-CV-8000 (N.D. Ohio 2004); Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1177 (E.D. Wash. 2009); Doe v. Northwestern Mutual Life Ins. Co., (D. S.C. 2012); In re Chantix (Varenicline) Prods. Liab. Litig., 889 F. Supp. 2d 1272, 1286, 1288, 1290 (N.D. Ala. 2012); Farmer v. Air & Liquid Systems Corp. at n.11 (M.D. Ga. 2018); In re Abilify Prods. Liab. Litig., 299 F. Supp. 3d 1291, 1306 (N.D. Fla. 2018).

[21] Michael D. Green, D. Michal Freedman & Leon Gordis, “Reference Guide on Epidemiology,” 549, 599 n.143, in Federal Judicial Center, National Research Council, Reference Manual on Scientific Evidence (3d ed. 2011).

Consensus Rule – Shadows of Validity

April 26th, 2023

Back in 2011, at a Fourth Circuit Judicial Conference, Chief Justice John Roberts took a cheap shot at law professors and law reviews when he intoned:

“Pick up a copy of any law review that you see, and the first article is likely to be, you know, the influence of Immanuel Kant on evidentiary approaches in 18th Century Bulgaria, or something, which I’m sure was of great interest to the academic that wrote it, but isn’t of much help to the bar.”[1]

Anti-intellectualism is in vogue these days. No doubt, Roberts was jocularly indulging in an over-generalization, but for anyone who tries to keep up with the law reviews, he has a small point. Other judges have rendered similar judgments. Back in 1993, in a cranky opinion piece – in a law review – then Judge Richard A. Posner channeled the liar paradox by criticizing law review articles for “the many silly titles, the many opaque passages, the antic proposals, the rude polemics, [and] the myriad pretentious citations.”[2] In a speech back in 2008, Justice Stephen Breyer noted that “[t]here is evidence that law review articles have left terra firma to soar into outer space.”[3]

The temptation to rationalize, and to advocate for reflective equilibrium between the law as it exists, and the law as we think it should be, combine to lead to some silly and harmful efforts to rewrite the law as we know it.  Jeremy Bentham, Mr. Nonsense-on-Stilts, who sits stuffed in the hallway of the University of London, ushered in a now venerable tradition of rejecting tradition and common sense, in proposing all sorts of law reforms.[4]  In the early 1800s, Jeremy Bentham, without much in the way of actual courtroom experience, deviled the English bench and bar with sweeping proposals to place evidence law on what he thought was a rational foundation. As with his naïve utilitarianism, Bentham’s contributions to jurisprudence often ignored the realities of human experience and decision making. The Benthamite tradition of anti-tradition is certainly alive and well in the law reviews.

Still, I have a soft place in my heart for law reviews.  Although not peer reviewed, law reviews provide law students a tremendous opportunity to learn about writing and scholarship through publishing the work of legal scholars, judges, thoughtful lawyers, and other students. Not all law review articles are non-sense on stilts, but we certainly should have our wits about us when we read immodest proposals from the law professoriate.

*   *   *   *   *   *   *   *   *   *

Professor Edward Cheng has written broadly and insightfully about evidence law, and he certainly has the educational training to do so. Recently, Cheng has been bemused by the expert paradox, which wonders how lay persons, without expertise, can evaluate and judge issues of the admissibility, validity, and correctness of expert opinion. The paradox has long haunted evidence law, and it is at center stage in the adjudication of expert admissibility issues, as well as the trial of technical cases. Recently, Cheng has proposed a radical overhaul to the law of evidence, which would require that we stop asking courts to act as gatekeepers, and to stop asking juries to determine the validity and correctness of expert witness opinions before them. Cheng’s proposal would revert to the nose counting process of Frye and permit consideration of only whether there is an expert witness consensus to support the proffered opinion for any claim or defense.[5] Or in Plato’s allegory of the cave, we need to learn to be content with shadows on the wall rather than striving to know the real thing.

When Cheng’s proposal first surfaced, I wrote briefly about why it was a bad idea.[6] Since his initial publication, a law review symposium was assembled to address and perhaps to celebrate the proposal.[7] The papers from that symposium are now in print.[8] Unsurprisingly, the papers are both largely sympathetic (but not completely) to Cheng’s proposal, and virtually devoid of references to actual experiences of gatekeeping or trials of technical issues.

Cheng contends that the so-called Daubert framework for addressing the admissibility of expert witness opinion is wrong.  He does not argue that the existing law, in the form of Federal Rules of Evidence 702 and 703, does not call for an epistemic standard for both admitting opinion testimony, as well for the fact-finders’ assessments. There is no effort to claim that somehow four Supreme Court cases, and thousand of lower courts, have erroneously viewed the whole process. Rather, Cheng simply asserts non-expert judges cannot evaluate the reliability (validity) of expert witness opinions, and that non-expert jurors cannot “reach independent, substantive conclusions about specialized facts.”[9] The law must change to accommodate his judgment.

In his symposium contribution, Cheng expands upon his previous articulation of his proposed “consensus rule.”[10] What is conspicuously absent, however, is any example of failed gatekeeping that excluded valid expert witness opinion. One example, the appellate decision in Rosen v. Ciba-Geigy Corporation,[11] which Cheng does give, is illustrative of Cheng’s project. The expert witness, whose opinion was excluded, was on the faculty of the University of Chicago medical school; Richard Posner, the appellate judge who wrote the opinion that affirmed the expert witness’s exclusion, was on the faculty of that university’s law school. Without any discussion of the reports, depositions, hearings, or briefs, Cheng concludes that “the very idea that a law professor would tell medical school colleagues that their assessments were unreliable seems both breathtakingly arrogant and utterly ridiculous.”[12]

Except, of course, very well qualified scientists and physicians advance invalid and incorrect claims all the time. What strikes me as breathtakingly arrogant and utterly ridiculous is the judgment of a law professor who has little to no experience trying or defending Rule 702 and 703 issues labeling the “very idea” as arrogant and ridiculous. Aside from its being a petitio principia, we could probably add that the reaction is emotive, uninformed, and uninformative, and that it fails to support the author’s suggestion that “Daubert has it all wrong,” and that “[w]e need a different approach.”

Judges and jurors obviously will never fully understand the scientific issues before them.  If and when this lack of epistemic competence is problematic, we should honestly acknowledge how we are beyond the realm of the Constitution’s seventh amendment. Since Cheng is fantasizing about what the law should be, why not fantasize about not allowing lay people to decide complex scientific issues? Verdicts from jurors who do not have to give reasons for their decisions, and who are not in any sense peers of the scientists whose work they judge are normatively problematic.

Professor Cheng likens his consensus rule to how the standard of care is decided in medical malpractice litigation. The analogy is interesting, but hardly compelling in that it ignores “two schools of thought” doctrine.[13] In litigation of claims of professional malpractice, the “two schools of thought doctrine” is a complete defense.  As explained by the Pennsylvania Supreme Court,[14] physicians may defend against claims that they deviated from the standard of care, or of professional malpractice, by adverting to support for their treatment by a minority of professionals in their field:

“Where competent medical authority is divided, a physician will not be held responsible if in the exercise of his judgment he followed a course of treatment advocated by a considerable number of recognized and respected professionals in his given area of expertise.”[15]

The analogy to medical malpractice litigation seems inapt.

Professor Cheng advertises that he will be giving full-length book treatment to his proposal, and so perhaps my critique is uncharitable in looking at a preliminary, (antic?) law review article. Still, his proposal seems to ignore that “general acceptance” renders consensus, when it truly exists, as relevant to both the court’s gatekeeping decisions, and the fact finders’ determination of the facts and issues in dispute. Indeed, I have never seen a Rule 702 hearing that did not involve, to some extent, the assertion of a consensus, or the lack thereof.

To the extent that we remain committed to trials of scientific claims, we can see that judges and jurors often can detect inconsistencies, cherry picking, unproven assumptions, and other aspects of the patho-epistemology of exert witness opinions. It takes a community of scientists and engineers to build a space rocket, but any Twitter moron can determine when a rocket blows up on launch. Judges in particular have (and certainly should have) the competence to determine deviations from the scientific and statistical standards of care that pertain to litigants’ claims.

Cheng’s proposal also ignores how difficult and contentious it is to ascertain the existence, scope, and actual content of scientific consensus. In some areas of science, such as occupational and environmental epidemiology and medicine, faux consensuses are set up by would-be expert witnesses for both claimants and defendants. A search of the word “consensus” in the PubMed database yields over a quarter of a million hits. The race to the bottom is on. Replacing epistemic validity with sociological and survey navel gazing seems like a fool’s errand.

Perhaps the most disturbing aspect of Cheng’s proposal is what happens in the absence of consensus.  Pretty much anything goes, a situation that Cheng finds “interesting,” and I find horrifying:

“if there is no consensus, the legal system’s options become a bit more interesting. If there is actual dissensus, meaning that the community is fractured in substantial numbers, then the non-expert can arguably choose from among the available theories. If the expert community cannot agree, then one cannot possibly expect non-experts to do any better.”[16]

Cheng reports that textbooks and other documents “may be both more accurate and more efficient” evidence of consensus.[17] Maybe; maybe not.  Textbooks are typically often dated by the time they arrive on the shelves, and contentious scientists are not beyond manufacturing certainty or doubt in the form of falsely claimed consensus.

Of course, often, if not most of the time, there will be no identifiable, legitimate consensus for a litigant’s claim at trial. What would Professor Cheng do in this default situation? Here Cheng, fully indulging the frolic, tells us that we

“should hypothetically ask what the expert community is likely to conclude, rather than try to reach conclusions on their own.”[18]

So the default situation transforms jurors into tea-leaf readers of what an expert community, unknown to them, will do if and when there is evidence of a quantum and quality to support a consensus, or when that community gets around to articulating what the consensus is. Why not just toss claims that lack consensus support?


[1] Debra Cassens Weiss, “Law Prof Responds After Chief Justice Roberts Disses Legal Scholarship,” Am. Bar Ass’n J. (July 7, 2011).

[2] Richard A. Posner, “Legal Scholarship Today,” 45 Stanford L. Rev. 1647, 1655 (1993), quoted in Walter Olson, “Abolish the Law Reviews!” The Atlantic (July 5, 2012); see also Richard A. Posner, “Against the Law Reviews: Welcome to a world where inexperienced editors make articles about the wrong topics worse,”
Legal Affairs (Nov. 2004).

[3] Brent Newton, “Scholar’s highlight: Law review articles in the eyes of the Justices,” SCOTUS Blog (April 30, 2012); “Fixing Law Reviews,” Inside Higher Education (Nov. 19, 2012).

[4]More Antic Proposals for Expert Witness Testimony – Including My Own Antic Proposals” (Dec. 30, 2014).

[5] Edward K. Cheng, “The Consensus Rule: A New Approach to Scientific Evidence,” 75 Vanderbilt L. Rev. 407 (2022).

[6]Cheng’s Proposed Consensus Rule for Expert Witnesses” (Sept. 15, 2022);
Further Thoughts on Cheng’s Consensus Rule” (Oct. 3, 2022).

[7] Norman J. Shachoy Symposium, The Consensus Rule: A New Approach to the Admissibility of Scientific Evidence (2022), 67 Villanova L. Rev. (2022).

[8] David S. Caudill, “The ‘Crisis of Expertise’ Reaches the Courtroom: An Introduction to the Symposium on, and a Response to, Edward Cheng’s Consensus Rule,” 67 Villanova L. Rev. 837 (2022); Harry Collins, “The Owls: Some Difficulties in Judging Scientific Consensus,” 67 Villanova L. Rev. 877 (2022); Robert Evans, “The Consensus Rule: Judges, Jurors, and Admissibility Hearings,” 67 Villanova L. Rev. 883 (2022); Martin Weinel, “The Adversity of Adversarialism: How the Consensus Rule Reproduces the Expert Paradox,” 67 Villanova L. Rev. 893 (2022); Wendy Wagner, “The Consensus Rule: Lessons from the Regulatory World,” 67 Villanova L. Rev. 907 (2022); Edward K. Cheng, Elodie O. Currier & Payton B. Hampton, “Embracing Deference,” 67 Villanova L. Rev. 855 (2022).

[9] Embracing Deference at 876.

[10] Edward K. Cheng, Elodie O. Currier & Payton B. Hampton, “Embracing Deference,” 67 Villanova L. Rev. 855 (2022) [Embracing Deference]

[11] Rosen v. Ciba-Geigy Corp., 78 F.3d 316 (7th Cir. 1996).

[12] Embracing Deference at 859.

[13]Two Schools of Thought” (May 25, 2013).

[14] Jones v. Chidester, 531 Pa. 31, 40, 610 A.2d 964 (1992).

[15] Id. at 40.  See also Fallon v. Loree, 525 N.Y.S.2d 93, 93 (N.Y. App. Div. 1988) (“one of several acceptable techniques”); Dailey, “The Two Schools of Thought and Informed Consent Doctrine in Pennsylvania,” 98 Dickenson L. Rev. 713 (1994); Douglas Brown, “Panacea or Pandora’ Box:  The Two Schools of Medical Thought Doctrine after Jones v. Chidester,” 44 J. Urban & Contemp. Law 223 (1993).

[16] Embracing Deference at 861.

[17] Embracing Deference at 866.

[18] Embracing Deference at 876.

Oreskes Excluded as Historian Expert Witness in Mann Case

February 28th, 2023

“It has been said that though God cannot alter the past, historians can; it is perhaps because they can be useful to Him in this respect that He tolerates their existence.”    

                Samuel Butler, Erewhon Revisited, ch. 14

 

It has been a while since I have written about the scientist defamation case of brought by climate scientist and advocate, Michael E. Mann, against National Review magazine, the Competitive Enterprise Institute, and Mark Steyn.[1] Back in 2014, I commented upon the oddity of a scientist’s claim of defamation against lay people for criticizing a scientist’s work.[2] Mann took umbrage to statements, critical of his work that generated a “hockey-stick” model of global temperature rises. Defendants apparently accused Mann of “molest[ing] and tortur[ing] data in the service of politicized science[,]” “engaging in data manipulation[,]” and creating the “fraudulent climate-change ‘hockey-stick’ graph[.]”[3] Mann naturally claims that the defendants’ statements are false and defamatory; the defendants contend that their statements are true.

In the hurly burly of work and life, I lost touch with the proceedings in Mann, but recently I became aware of interesting gatekeeping rulings, issued in 2021.[4] I was particularly intrigued by the activity of Naomi Oreskes, qua historian, who sought to offer an expert witness opinion in the Mann case. On July 26, 2021, Judge Alfred S. Irving, Jr., dashed Oreskes’ hopes of testifying as an historian, and told her not to bother coming to Washington for trial.[5]

Naomi Oreskes is a “professor of the History of Science, in Harvard University. She teaches and writes about the history of science. When not riding political hobby horses, Oreskes has written about the Idiocracy’s rejection of science,[6] but she has also shown herself to be untutored in the basics of scientific and statistical method.[7]

She is an advocate who, along with her posse, frequently weighs in against oil companies in litigation.[8] Oreskes has also written extensively to demonize industry’s motives and to advance her conspiracy theories in which manufacturing industry (but not lawsuit industry) is responsible for suppressing the truth of positions that Oreskes believes fervently.[9] She has decried the political discrediting of science, while participating in a political strategy to discredit her scientific opponents.[10] The line between trust and credulity can sometimes be hard to locate.

The defendants had moved in limine to exclude Oreskes’ proferred historian testimony,[11] under the District of Columbia’s standard for admitting and excluding expert witness opinion testimony.[12] Oreskes’ opinion, at issue in the Mann case, was on

  • the general basis for finding scientific research to be reliable, and
  • that “think-tanks” (including the defendant CEI) “ignore, misrepresent, or reject” principled scientific thought on environmental issues.

On the general issue of reliability, Oreskes proferred an opinion that scientific research is made reliable by

“the collective vetting and critical interrogation of claims through scientific workshop, meetings, conferences, and above all, publication in peer-reviewed journals, formal scientific assessments and reports of government scientific agencies and laboratories.”

Even on superficial review, this description appears woefully inadequate and incomplete. For Oreskes, scientific reliability seems to be all about meetings, publications, and governmental reviews, with no room for actual data gathered in attempts to refute hypotheses, or room for interrogating the data and their quality. Nonetheless, on this general issue of reliability, the Court found her opinion to acceptable but redundant to scientific witnesses who had first-hand knowledge of Mann’s work (as opposed to an historian). On the first part of her proferred opinion, Judge Irving expressed his skepticism that Oreskes’ opinion would be helpful to the jury; Oreskes’ testimony might give the jury a framework that could be used to assess whether Mann’s work was fraudulent or not. Judge Irving held, however, that Oreskes’ testimony ran afoul of the law in failing to “to use a scientific technique which applies reliable methodologies.”[13]

On the second proferred opinion, the ad hominem attack on the bona fides of CEI and similar “think-tanks,” Judge Irving found Oreskes, in her report, failed to provide any explanation of her methodology.[14]

As was the case with several of Plaintiff’s proffered experts, Dr. Oreskes’ report was devoid of any discussion of her methodologies. Mann’s lawyers sought to remedy the omission by adverting to Oreskes’ description, in her deposition testimony, of her “content analysis” methodology, as applied to the public statements of the CEI:

“So we read the documents. And as I said before, we applied a well-established method in social science, which is broadly accepted as being, you know, a reputable method of analyzing something, content analysis, in order to show that there was this fairly substantial disparity between what the company scientists were saying in their private reports and publishing in peer-reviewed scientific literature which was essentially consistent with what other scientists were saying versus what the company was saying in public in advertisements that were aimed at the general public.

                           * * * * *

In the case of ExxonMobil, we had the opportunity to do this analysis because the company itself had made public these documents. And they claimed in public that if you read these documents, you would see that everything was fine and that ExxonMobil had done nothing wrong.

We applied a well-established method in social science, which is broadly accepted as being, you know, a reputable method of analyzing something, content analysis, in order to show that there was this fairly substantial disparity between what the company scientists were saying in their private reports and publishing in peer-reviewed scientific literature which was essentially consistent with what other scientists were saying versus what the company was saying in public in advertisements that were aimed at the general public.”[15]

Alas, it turned out that this jargon-laden description of method was irrelevant because Oreskes admitted that she had not performed a “content analysis” in the Mann case.[16] When pressed to explain the methodology actually used in the Mann case, she candidly explained:

“If you want me to tell you what my method is, it’s reading and thinking. We read. We read documents. And we think about them.”[17]

The court found this explanation more than a little problematic. “Reading and thinking about documents” are not the sort of methodologies that are beyond the ken of the jury. Oreskes’ best effort to explain what she had done left “the Court is unable to distinguish why Dr. Oreskes is more capable than the average juror, who can also read and think about documents.”[18]

The court’s inability to fathom what Oreskes might offer was not due to any judicial disability. Oreskes’ “reading and thinking” had never been peer-reviewed, had no known success rate, and could not be replicated by other experts in her field. The court saw that Oreskes’ opinion had not come from scientific method, and that her opinion would be aptly characterized “as a historical narrative or research compilation than scientific testimony.”[19] Oreskes’ opinion could not be justified as expert experiential opinion because it was not based upon her personal experience; rather, her opinion was based upon her review of documents and reports of others.

Oreskes’ “expert” witness report regaled the court with her take on CEI’s previous actions and statements. Oreskes offered the opinion that CEI has a history of opposing “progressive” policies and that it regularly advocates against “valid and widely accepted scientific research.” Judge Irving recognized that these opinions were nothing more than Oreskes’ subjective historical summary of CEI’s actions, no doubt with a heavy dose of Oreskes’ personal animus against the CEI. As Judge Learned Hand declared almost 100 years ago, “[a]rgument is argument whether in the box or at the bar, and its proper place is the last.”[20]

As for methodology, the court found none. The court agreed with the CEI that “Dr. Oreskes made no effort to compile or catalogue CEI’s publications according to an objectively defined set of metrics.” Oreskes was thus excluded from the litigation in July 2021.[21]

The plaintiff and Naomi Oreskes were not content to leave matters as they were decided in Judge Irving’s order. Mann moved for reconsideration of Oreskes’ exclusion, with a more limited proffer of testimony that would address the “importance of scientific expertise and the significance of the scientific method and peer review process in scientific debate.”[22]

In this requested do-over, Mann submitted a supplemental declaration from Oreskes, in which she elaborated upon her methodology of “contextual exposition.” Mann further argued that Oreskes should be “permitted to testify regarding scientific principles to permit the jury to understand those principles and to apply them to facts without running afoul of the general rules relating to opinion testimony.”

To this end, Oreskes would give the jury a “contextual exposition…of the character and nature of scientific research.” Mann contended that this foundational opinion testimony was “crucial to enable the jury to reach its conclusions concerning the truth or falsehood of Defendants’ objectively verifiable statements of fact about Dr. Mann and his scientific research which produced the Hockey Stick Graph.”

Essentially, Mann was seeking to have Oreskes’ testimony admitted as a “teaching expert witness,” who would not provide her own personal opinion, but who would give the jury the relevant scientific principles that they may apply to the facts of the case as they find. Judge Irving accepted this more limited proffer, and modified his earlier ruling to permit Oreskes to give the so-called “contextual information” that renders scientific research reliable, such as the peer review process.[23] As noted above, this aspect of the Oreskes’ proffered testimony appears incomplete, with emphasis on “social control,” at the expense of valid inference and data quality and integrity. 

Judge Irving’s reconsideration gave Oreskes a very limited remit to testify at trial. His Honor emphasized, however, that most of what she had originally proposed for her testimony was “unreliable and irrelevant.” Oreskes will not be allowed to give her opinion over the history of “the debate over anthropogenic climate change,” or hold forth with opinions about the history and character of CEI’s “agenda.” Judge Irving reiterated his finding that Oreskes’ opinions on these matters “are not demonstrably the product of any scientific principle or method, and are largely irrelevant.”[24]

Furthermore, Oreskes will not be allowed to discuss Mann’s work, or whether or not his methodology is valid, or whether there is evidence or not of data manipulation or fraudulent behavior. As Judge Irving summarized the matter:

“Dr. Oreskes’ opinion in that regard would be entirely speculative given that she has not demonstrated any particular expertise or experience regarding Dr. Mann’s research. Neither her original expert report nor her supplemental declaration indicates any intimate knowledge of Dr. Mann’s work. Further, Dr. Oreskes’ expert report identifies her as an expert in the history of science and in geology, not as an expert in climate reconstruction. Dr. Oreskes has not demonstrated any specialized knowledge or experience concerning the substantive or factual aspects of the MBH research.”

Judge Irving also excised Oreskes’ claim, made in her belated supplemental declaration, that there is a consensus about the cause of climate change, or that there is a political and ideological basis for CEI’s opposition to the consensus. After all, Mann’s work could have been fraudulent, even if other, sound scientific work came to the same conclusion, and even if that conclusion were widely shared.[25]

The choice of Naomi Oreskes to serve as an expert witness was dubious on several fronts.  First, as a partisan in the climate science debates, Oreskes hardly brought objectivity to the courtroom to support plaintiff Michael Mann. While attacking CEI for political and ideological bias, Oreskes’ helped showcase her own biases, which have long been on display.[26] Mann would be more effectively served by presenting an expert on scientific method who was not such an extreme advocate. Second, as shown by her misidentification of the burden of proof with the coefficient of confidence, Oreskes previously had shown a lack of understanding of scientific and statistical method.[27] Mann might have considered that his case would be better supported by someone who had not made such glaring mistakes, in front of a national audience.

As for whether the historian aspect of Oreskes’ testimony could ever have succeeded, I am more doubtful. Historians who “read and think” often have little to offer beyond what lawyers can accomplish using documents presented to the trier of fact for interpretation.[28]

Presenting historian “expert” witnesses is a commonplace in occupational exposure litigations, involving silicosis or claimed asbestos-related diseases.[29] The use of such expert witnesses leads to serious abuses, by which argument and advocacy are surreptitiously presented as history.[30] Judge Irving’s exclusion of Naomi Oreskes is a valuable precedent for bench and bar.

Trial is set for June 12, 2023.


[1] Michael E. Mann v. National Review, CA 008263 B (filed in 2012, in the Washington, DC Superior Court, Civil Division).

[2] SeeClimategate on Appeal” (Aug. 17, 2014).

[3] Competitive Enter. Inst. v. Mann, 150 A.3d 1213, 1262-64 (D.C. 2016), as amended (Dec. 13, 2018), cert denied 140 S. Ct. 344 (2019).

[4] There is a useful compendium of rulings available through the CEI website.

[5] See District of Columbia Superior Court Order on Expert Witnesses (July 26, 2021) [Order]. T.C. Kelly, “Expert Testimony Excluded in Michael Mann Defamation Lawsuit,” Expert Pages (Aug. 11, 2021).

[6] Naomi Oreskes, Why Trust Science? (2019).

[7] See Playing Dumb on Statistical Significance” (Jan. 4, 2015); “ The Rhetoric of Playing Dumb on Statistical Significance – Further Comments on Oreskes” (Jan. 20, 2015); “Significance Levels Made Whipping Boy on Climate Change Evidence; Is 0.05 too Strict?Error Statistics (Jan. 4, 2015).

[8] See, e.g., Brief of Amici Curiae Robert Brulle, Center for Climate Integrity, Justin Farrell, Benjamin Franta, Stephan Lewandowsky, Naomi Oreskes, and Geoffrey Supran in Support of Appellees and Affirmance, County of San Mateo v. Chevron Corp., Nos. 18-15499, 18-15502, 18-15503, 18-16376 at 2 (9th Cir. 2019); Brief of Amici Curiae Robert Brulle, Center for Climate Integrity, Justin Farrell, Benjamin Franta, Stephan Lewandowsky, Naomi Oreskes, Geoffrey Supran and the Union of Concerned Scientists, City of Oakland v. B.P. PLC, No. No. 18-16663 (9th Cir. Mar. 20, 2019); Brief of Amici Curiae Robert Brulle, Center for Climate Integrity, Justin Farrell, Benjamin Franta, Stephan Lewandowsky, Naomi Oreskes, Geoffrey Supran and the Union of Concerned Scientists, Mayor and City Council of Baltimore  v BP PLC, No. 19-1644 (4th Cir. Sept. 3, 2019).

[9] Naomi Oreskes & Erik M. Conway, Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming (2010); Naomi Oreskes & Erik M. Conway, “Defeating the merchants of doubt,” 465 Nature 686 (2010). See also Geoffrey Supran & Naomi Oreskes, “Assessing ExxonMobil’s climate change communications (1977–2014),” 12 Envt’l Research Letters (Aug. 2017). Remarkably, Oreskes declared no conflicts of interest in this publication.

[10] Zoë Corbyn, “Naomi Oreskes: ‘Discrediting science is a political strategy’,” The Guardian (Nov. 2019).

[11] See Defendants Competitive Enterprise Institute and Rand Simberg’s Motion in Limine to Exclude the Expert Testimony of Dr. Naomi Oreskes (“MIL Oreskes”), filed on March 3, 2021.

[12] The standard is substantially the same as that articulated in Federal Rule of Evidence 702; see Motorola Inc. v. Murray, 147 A.3d 751 (D.C. Ct. App. 2016) (applying standard to case involving claims of brain cancer from the use of mobile telephones).

[13] Order at 23-24.

[14] Judge Irving noted that failure to explain methodology was a fatal flaw, citing Sacchetti v. Gallaudet Univ., 344 F. Supp. 3d 233, 250-51 (D.D.C. 2018).

[15] Plaintiff’s Opposition, Oreskes Deposition v.2 at 55:12-56:5.

[16] Id. at 33:5-15.

[17] Id. at 34:13-15.

[18] Order at 24-25 (citing Parsi v. Daioleslam, 852 F. Supp. 2d 82, 89 (D.D.C. 2012) (rejecting an expert opinion based solely on the experts “reading and viewing” and finding that reading, alone, does not constitute an acceptable methodology).

[19] Id. The court acknowledged that expert witness opinion could be “experiential,” but such a case, the witness must explain “how that experience leads to the conclusions reached, why that experience is a sufficient basis for the opinion and how that experience is reliably applied to the facts.” Id. (citing Arias v. DynCorp., 928 F. Supp. 2d 10, 15-16 (D.D.C 2013).

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

[21] Order at 25.

[22] Court Order on Expert Witnesses, in Michael E. Mann v. National Review, CA 008263 B, Washington, D.C, Superior Court, Civil Division (Jan. 22, 2022)

[Order II at 20].

[23] Order II at 22.

[24] Order II at 22-23.

[25] Order II at 23-24.

[26] See, e.g., Naomi Oreskes  & Erik M. Conway, The Big Myth: How American Business Taught Us to Loathe Government and Love the Free Market (2023).

[27] Oreskes, in the past, has shown a stunning disregard for the meaning of scientific and statistical concepts.[27]

[28] See, e.g., Quester v. B.F. Goodrich Co., Cuyahoga Cty., Ohio, C.P. Case No. 03-509539 (Jan. 12, 2008) (excluding historian Gerald Markowitz’s testimony as impermissible attempt to introduce expert witness opinion on defendants’ intent and motive) (Sweeney, J.).

[29] Nathan A. Schachtman, “On Deadly Dust and Histrionic Historians: Preliminary Thoughts on History and Historians as Expert Witnesses,” 2 Mealey’s Silica Litigation Report Silica 1, 2 (November 2003); Nathan Schachtman & John Ulizio, “Courting Clio:  Historians and Their Testimony in Products Liability Action,” in: Brian Dolan & Paul Blanc, eds., At Work in the World: Proceedings of the Fourth International Conference on the History of Occupational and Environmental Health, Perspectives in Medical Humanities, University of California Medical Humanities Consortium, University of California Press (2012); Scott Kozak, “Use and Abuse of ‘Historical Experts’ in Toxic Tort Cases,” in Toxic & Hazardous Substances Litigation (March 2015).

[30] See How Testifying Historians Are Like Lawn-Mowing Dogs” (May 15, 2010); “Courting Clio: Historians and Their Testimony in Products Liability Litigation” (May 24, 2010);  A Walk on the Wild Side (July 16, 2010); Counter Narratives for Hire (Dec. 13, 2010); “Narratives & Historians for Hire” (Dec. 15, 2010); “Courting Clio: Historians Under Oath – Part 1” (Dec. 17, 2011); “Courting Clio: Historians Under Oath – Part 2” (Dec. 17, 2011); “What Happens When Historians Have Bad Memories” (Mar. 15, 2014); “Too Many Narratives – Historians in the Dock” (July 14, 2014); Historians Noir (Nov. 18, 2014); “Lawyers as Historians” (Feb. 2, 2016); “Succès de scandale – With Thanks to Rosner & Markowitz” (Mar. 26, 2017); “More Rosner-Markowitz Faux History of Workplace Safety” (July 9, 2020).

Selikoff Timeline & Asbestos Litigation History (Revised)

February 26th, 2023

The critics and cheerleaders of Dr. Irving John Selikoff agree that he was a charming, charismatic, and courageous man, a compassionate physician, and a zealous advocate for worker safety and health. The consensus falls apart over the merits of Selikoff’s actual research, his credentials, and his advocacy tactics.[1]

Selikoff’s collaborators, protégés, and fellow travelers tend to brand any challenge or criticism as “scurrilous.”[2] They attack the messenger for attacking the messenger, who attacked the messenger, u.s.w.. Certainly in his lifetime, Selikoff attracted harsh and vituperative attacks, some of which were mean-spirited and even anti-semitic. Although I am not a Jew, I am, following Jonathan Miller, “Jew-ish, just not the whole hog.” As such, I can appreciate the ire of some of Selikoff’s defenders over the nature of these attacks.

Selikoff’s legitimate achievements should not be diminished, and his defenders are correct to bemoan the ad hominem attacks on Selikoff, based upon ethnicity and personal characteristics. Some attacks, however, were merited. The time has come to stop evaluating the message by its messenger, and to pay attention to the evidence. Selikoff’s defenders and hagiographers are wrong, therefore, to claim that Selikoff’s training, scientific acumen, advocacy, and false positive claims are somehow off limits. Selikoff advanced his scientific and political agenda by promoting his reputation and work, and he thus put his credentials, work, and methods into issue. Selikoff’s contributions to public health in publicizing the dangers of high exposure, long-term asbestos exposure do not privilege every position he took. Selikoff is a difficult case because he was wrong on many issues, and his reputation, authority and prestige ultimately became much greater than the evidence would ultimately support.

Although Selikoff died in 1992, his legacy lives on in the perpetual litigation machine that is run by the litigation industry and Selikoff’s juniors and imitators, who serve as testifying expert witnesses. One of Selikoff’s great achievements, the federalization of worker safety and health in the Williams-Steiger Occupational Safety and Health Act of 1970,[3] languishes because of inadequate resources for enforcement and frivolous efforts to address non-existent problems, such as the lowering of the crystalline silica permissible exposure limit. Activists have taken to redress the problem by advocating for nugatory “warnings” from remote suppliers, in the face of employer failures to monitor and supervise workers and the workplace, and to provide administrative, engineering, and personal protective controls.

Selikoff diverted regulatory attention from asbestos fiber type, with the result that the OSHA PELs were lowered for both chrysotile and amphibole asbestos, thus leaving the ultra-hazardous crocidolite asbestos in use. Selikoff perpetuated a good deal of mischief and misinformation to keep his myth that all fiber types are the same (and that “asbestos is asbestos is asbestos”). In doing so, he actually hurt many people.

An anonymous snark on Wikipedia noted some of my blog posts about Selikoff, and offered the lame criticism that my writings were not peer reviewed.[4] The snark (Tweedale?) was of course correct on this limited point, but generally in this field, peer review is worth a warm bucket of spit. And there is the matter that the anonymous critic was offering a criticism that was also not peer reviewed.

Selikoffophiles continue to tell tall tales about Selikoff’s work and in particular about how he became involved in asbestos medicine.[5]  So here is a timeline of Selikoff’s life and asbestos work, an update of an earlier version. If anyone notes an error or inconsistency in this time line, please let me know, provide better sources, and ask for a correction. If I am wrong, I will readily note the correction and eat my words, but I am sure they will be quite digestible.[6]

1915-01-15.  Irving John Selikoff was born as Irving Selecoff in the brain basket of America, Brooklyn, New York, to Abraham and Matilda (Tillie) Selecoff.[7]  His father, Abraham, was born on April 6, 1885, in the Kyiv oblast of what is now Ukraine.[8]

1920.  According to the 1920 census, the Selekoff family lived at 816 179th Street, in the Bronx. Irving’s father, Abraham, was self-employed as a hat manufacturer, doing business later as United Headwear Corporation.[9]  The family had two children, Irving, and his older sister, Gladys.

1930. The asbestos workers’ journal published a story about the (non-malignant) risks of asbestos exposure.[10]

1935-06.  Selikoff was graduated from Columbia University, with a B.S. degree.

1935-12-24.  Selikoff arrived in Boston from Yarmouth, Nova Scotia, on the S.S. Yarmouth, on December 24, 1935, apparently en route from Scotland.

1936.  Dr. Alice Hamilton, physician and noted labor activist, wrote in a labor union journal to urge more attention to industrial dusts, the knowledge of dangers of which was[11] “still very limited except with regard to silica and asbestos.”

1936-08.  Selikoff sat for the university entrance boards in Scotland.

1936-09-27.  Selikoff married Lydia Kapilian, in the Bronx.[12]

1936-10-12. Irving Selecoff arrives in Liverpool, from New York, aboard the S.S. Samaria.

1936-10.  Selikoff entered Anderson’s College of Medicine, in Glasgow, Scotland.[13]

1936-12-28. Irving John Selikoff is listed in the UK, Medical and Dental Students Registers, 1882-1937, registration date December 28, 1936, in Scotland.

1936.  Alice Hamilton published an article on the risks and benefits of industrial asbestos use, in a key labor unionist journal. Alice Hamilton, “Industrial Poisons,” 43 The American Federationist 707-13 (1936).

1937-04-26.  Selikoff arrived in New York, from Greenock, Scotland, on the S.S. Carinthia.

1937-10-10. Irving Selecoff arrived in Glasgow, Scotland, from New York City, on board the SS. Cameronia.

1938-07-14.  Irving J. Selecoff arrived in Quebec, Canada, from Greenock, Scotland, on the S.S. Duchess Atholl.

1939-06-24.  Irving Selecoff arrived in New York, from Liverpool, London, on the S.S. Mauretania. Because of the developing hostilities in Europe, Selikoff apparently did not return to Glasgow, in the fall of 1939.

1939-11.  Unable to return to Scotland, Selikoff applied to Melbourne University for coursework to finish his non-degree course of qualification for medication practice in the United Kingdom.[14]

1940-03-04.  Selecoff (as his name was then often spelled) arrived in Vancouver from Sydney, on the S.S. Aorangi.

1940-04.  Irving Selikoff was living with his parents, and his married sister and her family, in Rye, New York, according to the 1940 census, taken on April 10, 1940.

1940-05-27.  Selikoff enrolled in the University of Melbourne as a non-degree student, for coursework to finish his qualification for medical license in Scotland.[15]

1941-03-24.  John Selecoff arrived in Los Angeles, California, from Sydney, Australia, on the S.S. Mariposa. According to Bartrip, Selikoff had completed his last course at the University of Melbourne, for his “tailor-made” program, on

1941-02-27. Selikoff never gained entrance to a degree program at Melbourne.[16]

1941-04-21. Irving John Selikoff registered for the draft, in Port Chester, New York.

1941.  Selikoff joined the Mount Sinai Hospital as an assistant in Anatomy and Pathology, “immediately following his university training.”[17]

1943-11-01.  Selikoff received an M.D., degree from Middlesex University,[18] after two semesters in residence. This school was regarded as “substandard” and not approved by the American Medical Association. The school lost its accreditation in 1946, and closed.[19] After receiving this degree, Selikoff continued his efforts to return to Scotland, to complete his “triple qualification” for medical licensure in Scotland, which would allow him to sit for the licensing examination in one of the United States.

1943 – 1944.  Selikoff served as an intern, at the Beth Israel Hospital, in Newark, New Jersey.[20]

1944 – 1946. Selikoff served as a resident, at the Sea View Hospital, in New York City.[21]

1945-04-23.  Selikoff was listed in the British Medical Registry, based upon his qualification by the Scottish Conjoint Board for his work at Anderson’s and his non-degree work at the University of Melbourne.[22]

1943-06-02. Irving J Selecoff arrived in Montreal, Quebec, Canada, from Liverpool, aboard the S.S. Axel Johnson.

1945-06-02.  Selikoff arrived in Montreal, Quebec, from Liverpool, England, on the S.S. Axel Johnson.

1945-12-21. Selikoff’s mother, Tillie, died.

1946-02.  Selikoff married Celia Schiffrin in Manhattan.[23]  It was the second marriage for both bride and groom.

1947.  After having left Mt. Sinai Hospital, in 1943, for an internship and a residency, Selikoff resumed his association with Mt. Sinai Hospital.[24]

1947-06-30. Selikoff’s father, Abraham Selecoff, married Anna Susser, in Manhattan.[25]

1949.  Selikoff opened a medical office at 707 Broadway, Paterson, New Jersey,[26] not far from a factory run by the Union Asbestos and Rubber Company (UNARCO). In the same year, the Selikoffs were living at 965 Fifth Avenue, near 78th Street, in Manhattan.[27]

1950.  Selikoff’s medical practice in Paterson, New Jersey, afforded him the opportunity to observe “the incidence of lung disease among workers at the Union Asbestos and Rubber Company (UNARCO),”[28] which operated one of its factories in Paterson.

1950-04-05. Irving J. Selikoff and his wife Celia resided at 93 Broadway, Paterson, New Jersey, USA, according to the 1950 census. By the early 1950s, Selikoff and his wife had moved to 505 Upper Boulevard, Ridgewood, New Jersey.

1951.  New Jersey lawyer Carl Gelman retained Dr. Irving Selikoff to examine 17 workers from the Paterson plant of Union Asbestos and Rubber Company (UNARCO). Gelman filed workers’ compensation claims on behalf of the UNARCO workers.[29]

1952.  Supported by Selikoff’s report, UNARCO worker Anton Szczesniak settled his worker’s compensation case, involving “intestinal cancer,” for $2,000 in 1952.[30] Selikoff published data on the carcinogenicity of amosite in 1972,[31]  a delay of twenty years.[32]

1952.  Selikoff and colleagues published the results of a clinical trial of isoniazid for tuberculosis patients.[33]

1952.  Selikoff was featured in Life magazine coverage of isoniazid, a chemotherapy for tuberculosis.[34]

1952.  Selikoff was an assistant attending physician for thoracic diseases in the department of thoracic diseases at Mt. Sinai Hospital. In this year, Selikoff delivered the monthly Physiological Chemistry Seminar lecture at Mt. Sinai Hospital on: “Antitubercular Hydrazines,” along with Drs. H. H. Fox and Richard J. Schnitzer, of Hoffman-La Roche.

1954.  UNARCO closed its Paterson, New Jersey plant, and moved it to Tyler, Texas.[35]

1955.  Selikoff received the Albert Lasker Clinical Medical Research Award for his work on the clinical trial of isoniazid to treat tuberculosis, along with Walsh McDermott and Carl Muschenheim, of the Hoffmann-La Roche Research Laboratories, and Edward H. Robitzek, of the Squibb Institute for Medical Research.[36]

1955.  Selikoff’s involvement in the isoniazid clinical trials continued to attract media attention. His first television appearance was panned, but he would later develop considerable public speaking skills.[37]

1955.  Sir Richard Doll published his epidemiologic study of lung cancer among British asbestos workers.[38]  This study was known to Selikoff, who relied upon it in his litigation reports to support the compensation claims of asbestos workers in the 1950s.[39]

1955. In 1955, American labor unions were well aware of the claim that asbestos causes lung cancer. Herbert K. Abrams, union physician and the Medical Director of Local 25 Chicago, Building Service Employees International Union, concluded that asbestos causes cancer in a prominent union journal.[40]

1956.  Selikoff became an associate attending physician for thoracic disease at Mt. Sinai Hospital.

1957.  For many years, Frederick Legrand had been a pipecoverer and asbestos worker for asbestos contracting firms. In February 1956, Legrand filed a successful claim for worker’s compensation for disability due to asbestosis.[41] Attorney William L. Brach filed perhaps the first civil action (as opposed to worker’s compensation claim), on behalf of LeGrand, against Johns-Manville, for asbestos-related disease, on July 17, 1957. Frederick LeGrande v. Johns-Manville Prods. Corp., No. 741-57 (D.N.J.).[42] Trial commenced on March 4, 1959, before the Hon. Honorable Reynier J. Wortendyke, Jr. In the middle of trial, Johns-Manville (JM)  settled the case for $35,000.[43] According to various accounts, JM badly mishandled the defense by falsely asserting that it had no knowledge of potential asbestosis hazards to end-users such as LeGrand. The defense had the dual liability of both being untrue and depriving JM of affirmative defenses of contributory negligence and assumption of risk. JM was apparently able to obtain a stipulation that LeGrand’s condition was not the result of asbestos in JM’s product, which JM used to hide the JM settlement from subsequent claimants. Frederick Legrand died in the fall of 1959.[44]

1957-07. The asbestos insulators’ union’s periodical, distributed to its members, notes that “[t]he problem of hazardous materials was again discussed with the importance of using preventative measures to eliminate inhalation. It is suggested that, when working under dusty conditions, respirators should be used at all times and gloves whenever conditions warrant.”[45]

1957-10. President Sickles, at the International Convention of the Asbestos Heat, Frost and Insulators Union, reported to his union’s delegates that he, “[b]eing well aware of the health hazards in the Asbestos industry, requested authority for the General Executive Board to make a study of the health hazards … that will enable the Board to adopt any policies that will tend to protect the health of our International membership.”[46]

1960.  Dr. J. Christopher Wagner published a case series of mesothelioma among persons exposed to crocidolite, in the region of South Africa where crocidolite is mined and milled. After this publication, the causal role of crocidolite became quickly accepted in the scientific and medical community.[47]

1960-1961.  Selikoff published two papers on the patho-physiology of asbestosis, based on data from 17 UNARCO workers,[48] obtained from his medico-legal evaluations of the men.[49]

 

Irving and Celia Selikoff from their 1961 Brazilian visa documents

1961-05. Asbestos insulators’ union discussed collaboration with scientists to discuss lung cancer and other diseases among its membership.[50]  Union members, intensely interested in legal redress for compensation, became aware of Selikoff’s research hypothesis in advance of Selikoff’s survey of the members’ smoking habits, which the workers had a motive to under report.

1961-11. The Asbestos insulators’ union’s magazine featured a full page warning of the grim reaper urging insulators to “Wear Your Respirator.”[51] The warning was developed under the guidance of C. V. Krieger of Local No. 28, Safety Superintendent at the Long Beach Naval Shipyard.

1962-07-12.  Selikoff visited Asbestos Corporation of America, an intermediary broker of asbestos fibers. In a memorandum Selikoff prepared from his discussions with Wade I. Duym, the general manager of the company, and others, he detailed the widespread use of amphibole asbestos fibers in a variety of products. He noted that amosite was used primarily in the insulation trade, and that it was the asbestos “of choice” for sprayed-on products, high temperature insulating cements and pipecovering (magnesia and calcium silicates). Selikoff described crocidolite, from Africa and Bolivia, as a strong, chemically resistant, relatively inexpensive fiber that was used in asbestos cement products, and in Kent cigarette filters.

1962-09. Selikoff presented to a meeting of the Asbestos Workers, to request their help in conducting his study of insulator mortality and morbidity. Irving Selikoff, “Speech at Asbestos Workers’ Union Annual Meeting,” The Asbestos Worker 8 (Sept. 1962).

1962.  Asbestos insulators’ union acknowledged that its leadership has been collaborating with Dr. Irving Selikoff.[52] In September 1962, Selikoff and colleagues began physical examinations of members of the New York and New Jersey locals.[53] `

1962.  In a publication for Naval personnel, with virtually no circulation in the general industrial community, the United States government acknowledged that shipyard and on-board exposures greatly exceeded the ACGIH’s then current TLV for asbestos.[54]

1963.  Selikoff established the Environmental Sciences Laboratory, later known as the Division of Environmental and Occupational Medicine, in would become the Mt. Sinai School of Medicine’s Department of Community Medicine.

1963-02. The asbestos insulation workers’ union announces that it has begun a large-scale program of examinations for asbestos-related disease in the members of the New York and New Jersey locals.[55]

1964.  Selikoff published his first article on cancer in a cohort of union asbestos insulators from New York and New Jersey.[56] Selikoff and his co-authors failed to disclose funding from the union, or the union members’ awareness of the research hypotheses under investigation.

1964.  In October 1964, Selikoff organized and co-chaired (with Dr. Jacob Churg) a conference, “The Biological Effects of Asbestos, for the New York Academy of Sciences, in New York City. The conference featured presentations and papers from many international investigators. Several presenters, including Selikoff, documented the prevalent use of amphibole asbestos (both crocidolite and amosite) in the United States.[57]

1965.  Papers presented at the 1964 New York Academy of Sciences conference were published in late 1965, in a non-peer reviewed publication, volume 132, of the Annals of the New York Academy of Sciences.

1965.  Selikoff testified on behalf of an insulator who claimed that asbestos exposure caused his colorectal cancer.[58] Forty years later, the Institute of Medicine (now the National Academy of Medicine) comprehensively reviewed the extant evidence and announced that the evidence was “suggestive but not sufficient to infer a causal relationship between asbestos exposure and pharyngeal, stomach, and colorectal cancers.”[59] None of Selikoff’s publications, including those on asbestos and colorectal cancer, disclosed his litigation testimonies for claimants.

1966 – 1972.  Selikoff continued to testify frequently in civil action and in worker compensation proceedings for claimants who alleged asbestos-related injuries.[60]  In 1972, Andrew Haas, President of the asbestos workers’ union thanked Selikoff for his “frequent” expert witness testimony on behalf of union members.[61]

1967-09. In an address to the International Association of Heat and Frost Insulators and Asbestos Workers, Selikoff acknowledged the widespread use of amosite, particularly in shipyards, the absence of lung cancer among non-smoking insulation workers, and the failure of more than 9 out of 10 insulators to wear respirators on dusty jobs. See Irving J. Selikoff, Address to the delegates of the twenty-first convention of the International Association of Heat and Frost Insulators and Asbestos Workers at 8, 9-10, 24 (Chicago, Illinois, Sept. 1967) (“I have yet to see a lung cancer in an asbestos worker who didn’t smoke cigarettes. … “[C]ancer of the lung could be wiped out in your trade if you people wouldn’t smoke cigarettes, period.”).

1968-09.  Selikoff “warns” the United States of asbestos hazards that existed and continue to exist in the government’s shipyards.[62] The warning was largely about seeking media attention by Selikoff; the government, and especially the Navy, had long known of asbestos hazards.[63]

1968-05.  Selikoff testified that all fibers are equally potent, to Congress in support of a bill that would become the OSH Act.

1968. The Mount Sinai School of Medicine opened in 1968, as part of The City University of New York. The first class in the newly formed medical school had 36 students in the entering class. The school was chartered in 1963. It is now known as the Icahn School of Medicine at Mount Sinai.

1969.  Selikoff served as president of the New York Academy of Sciences.

1969-05. Selikoff acknowledged that only four percent of insulators wore a mask despite extensive warnings.[64]

1972.  In a published study of variability in the interpretation of chest radiographs, Selikoff was shown consistently to over-read chest radiographs for potential asbestos-related abnormalities, when compared with other pulmonary experts on pneumoconiosis.[65]

1973.  Selikoff testified for the government in United States v. Reserve Mining Co., No. 5-72 Civil 19 (D. Minn. Sept. 21, 1973).[66]  On September 20, Selikoff testified about the town where Reserve Mining’s taconite mine was located: “I think we ought to have a sign at the entrance to sections of the town ‘Please Close Your Windows Before Driving Through’. I certainly would want to close mine.” When his testimony continued the following day, Selikoff acknowledged that he had been “facetious” in his previous day’s testimony.[67]

1974. After having given “facetious” testimony, Selikoff reduced his testifying activities. Marxist historians Jock McCulloch and Geoffrey Tweedale have falsely suggested that Selikoff “avoided the drama of the courtroom and the role of the expert witness” because of the drain on his time, his desire to avoid antagonizing industry, and his need to prevent discovery of trade union medical files.[68]

1974-05-20.  Selikoff’s father, Abraham Selecoff, died in Florida.[69]

1974.  Selikoff published a review on asbestos and gastrointestinal cancer, without disclosing his funding from the asbestos insulation union or his receipt of fees for litigation work in which he maintained a causal relationship in advance of any data.[70]

1978-07.  The National Cancer Institute (NCI) invited Dr. Hans Weill to co-chair a conference on lung cancer surveillance. Ten days later, the NCI retracted the invitation. When Weill inquired about the reasons for the shoddy treatment, an NCI official (Margaret Sloan) told him that “representatives of organized labor” objected to his participation. Sloan’s superior at NCI stated that Selikoff had raised the question whether the conference’s recommendations would lose credibility if Weill were a co-chair. When asked about his role in this sordid affair, Selikoff equivocated, saying he had “simply” said that “[s]ince Weill was a consultant to the Asbestos Information Center, I didn’t know if this would enhance or detract from hearing all points of view.”[71]

1979-11-05.  Barry Castleman, career testifier for the asbestos lawsuit industry, prepared a memorandum to Selikoff to urge him to resist allowing discovery of asbestos worker union members’ knowledge of the hazards of asbestos.[72]

1980-07-29.  A Newsday journalist reports that Selikoff is loath to talk about himself, and that he threatens to cut short the interview when asked about his background.[73]

1981.  Sir Richard Doll and Professor Richard Peto published a rebuttal to wildly exaggerated asbestos risk assessments based upon Selikoff’s insulator studies.[74]

1984.  Selikoff prepared a report on his group’s epidemiologic study of Electric Boat employees, who were engaged in the construction of submarines.[75]  The data did not fit the Mt. Sinai Catechism of large increased risks.[76]  Selikoff never published these data in a medical journal or a textbook.[77]

1985-03-10. Selikoff retires from Mount Sinai Medical School.[78]

1986-03.  Selikoff’s wife, Celia, died.[79]

1987 – 1989.  Selikoff’s insulator cohort study data took on an outsize importance in litigation because of plaintiffs’ heavy reliance upon his studies in court cases. When litigants asked for these data, Selikoff consistently refused to share, which necessitated federal court intervention.[80]

1988.  Selikoff and William Nicholson prepared a manuscript report of a study of the mortality experience at a New Jersey asbestos product manufacturing plant of Johns Manville.[81] Their report documented the substantial use of crocidolite in various products, and the resulting horrific mesothelioma mortality at this plant. Selikoff never published this crocidolite-exposed cohort, although he tirelessly republished his insulator cohort data repeatedly with the misrepresentation that the insulators were not exposed to crocidolite.

1990-06-07. Selikoff conspired with Ron Motley and others to pervert the course of justice by inviting judges with active asbestos dockets to a one-sided conference on asbestos science, and to pay for their travel and lodging. In his invitation to this ex parte soirée, Selikoff failed to mention that the funding came from plaintiffs’ counsel.[82]  Shortly after the Third Circuit spoke on the Mt. Sinai dress rehearsal for the plaintiffs’ asbestos property damage trial case, Judge Jack Weinstein issued a curious mea culpa. Because of a trial in progress, Judge Weinstein did not attend the “Third Wave” conference, but he and a state 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.”[83]

What is curious is that Judge Weinstein, usually a careful judge and scholar, was so incorrect about Dr. Selikoff’s having never testified. His error could have been avoided by a simple search in the Westlaw or LexisNexis databases. Judge Weinstein’s account points directly to Dr. Selikoff as the source for this falsehood.[84]

1990-10-02.  Selikoff wrote to Judge Jack Weinstein and Justice Helen Freedman, presumably after the “regrettable” ex parte luncheon meeting, to hold forth with his views on the health effects of occupational and para-occupational exposure to asbestos.

1992-05-20.  Selikoff died several months before the U.S. Court of Appeals for the Third Circuit condemned the Selikoff-Motley conspiracy.[85]

2013.  Follow up of the national insulator cohort fails to support multiplicative interaction between smoking and asbestos for lung cancer outcomes in the absence of asbestosis.[86]


[1] Rachel Maines, Asbestos and Fire: Technological Tradeoffs and the Body at Risk 155 (2005) (“charming, courageous, and compassion medical professional with more charisma than credentials”).

[2] Jock McCulloch & Geoffrey Tweedale, Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619 (2007); “Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas” (Oct. 4, 2014); David Egilman, Geoffrey Tweedale, Jock McCulloch, William Kovarik, Barry Castleman, William Longo, Stephen Levin, and Susanna Rankin Bohme, “P.W.J. Bartrip’s Attack on Irving J. Selikoff,” 46 Am. J. Indus. Med. 151, 152 (2004) [Egilman (2004)].

[3] 84 Stat. 1590, et seq., 29 U.S.C. § 651, et seq.

[4]The Legacy of Irving Selikoff & Wicked Wikipedia” (Mar. 1, 2015). See also “Hagiography of Selikoff” (Sept. 26, 2015); “Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff” (Jan. 4, 2014).

[5] See, e.g., Philip Landrigan, “Stephen Levin, MD, honored with the Collegium Ramazzini’s Irving J. Selikoff Memorial Award in 2009.”

[6] See Wikipedia, “Irving Selikoff” (last visited Dec. 4, 2018).

[7] Kings County Birth Certificate no. 4595 (Jan. 15, 1915). His family later adopted the surname Selikoff. Irving Selikoff’s social security records list his father as Abraham Selikoff and his mother as Tillie Katz.

[8] Abraham Selecoff World War II draft registration, serial no. U1750.

[9] Abraham Selecoff World War II draft registration, serial no. U1750.

[10] See “The Asbestos Menace,” The Asbestos Worker 9-11 (Sept. 1930).

[11] Alice Hamilton, “Industrial Poisons,” American Federationist (1936). This journal was “The Official Magazine of the American Federation of Labor.”

[12] Bronx marriage certificate no. 8246 (1936); Bronx marriage license no. 8652 (1936). Irving’s parents were listed as Abraham Selikoff and Tillie Katz. His residence was at 109 W. 112th Street. Lydia was listed as the daughter of Mendel Kapilian and Bessie Weller. Irving and Lydia were divorced sometime between 1939 and 1941. The marriage certificates stated Lydia to have been 21 years old. Her Social Security records (SSN 112-052-2143), however, gave her birth date as April 22, 1917, (making her 19), and subsequent marriage names of Quint and Teichner.

[13] This and other details of Selikoff’s medical education come from Peter Bartrip’s exposé. Although Bartrip’s research was attacked for its allegedly gratuitous attacks on Selikoff’s research prowess, Bartrip’s account of Selikoff’s medical education in Scotland, Australia, and the United States has gone largely unrebutted, and must for the present be accepted. Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 8 (2003) [Bartrip 2003]; Peter Bartrip, “Around the World in Nine Years: A Medical Education Revisited,” 59 J. History of Med. 135 (2004). One group of plaintiffs’ expert witnesses took Bartrip to task for not disclosing that he had served as a defense expert witness, but none of the complainants disclosed their substantial testimonial adventures for the litigation industry! While making some interesting points, these critics of Bartrip did not really contest his historical work on Selikoff: “Bartrip’s critiques of Anderson’s College (AC) and Middlesex University School of Medicine (MSUM) may be accurate, but are beside the point.” David Egilman, Geoffrey Tweedale, Jock McCulloch, William Kovarik, Barry Castleman, William Longo, Stephen Levin, and Susanna Rankin Bohme, “P.W.J. Bartrip’s Attack on Irving J. Selikoff,” 46 Am. J. Indus. Med. 151, 152 (2004).

[14] Bartrip 2003, at 15 & n.44-51.

[15] Bartrip 2003, at 17 & n.54-55.

[16] Bartrip 2003 at 18.

[17] William J. Nicholson & Alvin S. Teirstein, “Remembering Irving J. Selikoff,”  61 Mt. Sinai J. Med. 500 (1994) [Nicholson & Teirstein]. This account seems doubtful; Selikoff would not have an M.D. degree until 1943, and then from a school that was about to lose its accreditation.

[18] See Stephen Rushmore, “Middlesex University School of Medicine,” 230 New Engl. J. Med. 217 (1944).

[19] Anthony Seaton, “The Strange Case of Irving Selikoff,” 60 Occup. Med. 53 (2010); Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003) [cited as Bartrip].

[20] Bartrip 2003 at 22.

[21] Bartrip 2003 at 22.

[22] Bartrip 2003 at 21.

[23] New York County marriage license no. 3879 (Feb. 2, 1946). Celia had been married to Nathan Michaels in 1937. Manhattan Marriage License no. 21454 (1937).

[24] Nicholson & Teirstein.

[25] Manhattan Marriage License  21527 (1947).

[26] City Directory of Paterson, New Jersey at p. 218 (1949).

[27] Manhattan Telephone Directory (1949).

[28] George W. Conk, “Deadly Dust: Occupational Health and Safety as a Driving Force in Workers’ Compensation Law and the Development of Tort Doctrine,” 69 Rutgers L. Rev. 1140, 1154 & n. 136 (2017).

[29] Jon L. Gelman, “History of Asbestos and the Law” (Jan. 2, 2001). Carl Gelman was a life-long Paterson resident. His legal practice specialized in workers’ compensation, and he chaired state bar association’s workers’ compensation section for several years. His practice represented claimants from 1936, until his retirement in 1986. In the mid-1970s, with Karl Asch, Gelman’s firm sued asbestos suppliers to Raybestos Manhattan on behalf of multiple employees.Gelman died on February 24, 2009. “Obituary for Carl Gelman,” The Record/Herald News (Mar. 16, 2009); “163 Who Had Jobs at Raybestos Sue,” N.Y. Times (May 7, 1975). The suit for $326 million settled for $15.5 million.

[30] Barry I. Castleman, Asbestos: Medical and Legal Aspects at 142 (1984); Matt Mauney, “Unarco,” Mesothelioma Center (Nov. 2018). Of course, there were no data to support this claim in 1952. Selikoff was publically and positionally committed to his causal hypothesis as a conclusion well in advance of conducting any studies or having any supporting data.

[31] Irving J. Selikoff, E. Cuyler Hammond, and Jacob Churg, “The carcinogenicity of amosite asbestos,” 25 Arch. Envt’l Health 183 (1972). This 1972 publication was the first epidemiologic study on the carcinogenicity of amosite.

[32] David E. Lilienfeld, “The Silence: The Asbestos Industry and Early Occupational Cancer Research – A Case Study,” 81 Am. J. Pub. Health 791 (1991).

[33] Irving J. Selikoff, Edward H. Robitzek, and George G. Ornstein, “Treatment of pulmonary tuberculosis with hydrazine derivatives of isonicotinic acid,” 150 J. Am. Med. Ass’n 973 (1952).

[34] “TB Milestone,” Life (Mar. 3, 1952).

[35] Irving J. Selikoff, “Asbestos in Paterson, New Jersey and Tyler, Texas – A Tale of Two Cities,” Transcript of Lecture (Houston, Texas, Oct. 11, 1979).

[36] SeeIsoniazid for treating tuberculosis.”

[37] See “Medical Horizons,” Broadcasting * Telecasting at 14 (Nov. 21, 1955) (describing Selikoff as a plodding presenter). See alsoIrving Selikoff – Media Plodder to Media Zealot” (Sept. 9, 2014).

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

[39] Selikoff letter to Thomas Mancuso (Mar. 30, 1989).

[40] Herbert K. Abrams, “Cancer in Industry,” American Federationist (1955). Dr. Abrams’ article was republished in many union newsletters. See Herbert K. Abrams, “Cancer in Industry,” 69 The Painter & Decorator 15, 16 (Mar. 1955); see also Lester Breslow, LeMar Hoaglin, Gladys Rasmussen & Herbert K. Abrams, “Occupations and Cigarette Smoking as Factors in Lung Cancer,” 44 Am. J. Pub. Health. 171, 171 (1954).

[41] A. C. & S., Inc. v. Asner, 104 Md. App. 608, 633, 657 A.2d 379 (Md. Ct. Spec. App. 1995).

[42] Paul Brodeur, Outrageous Misconduct: The Asbestos Industry on Trial 236-39 (1985). According to Brodeur’s account, Johns-Manville’s defense was clever by halves. By claiming that the company had no knowledge that asbestos could be harmful to applicators such as LeGrand, the company deprived itself of assumption-of-risk and contributory negligence defenses.  The company also set itself up to be brutally contradicted by internal documents and communications that showed an awareness of hazards to pipecoverers. By the time J-M understood that the question of responsibility required acknowledging potential hazards that were in the control of the contractors themselves (such as the use of proper respirators and the like), the company filed for bankruptcy.

[43] Greg Gordon, “Health studies drew little action,” Star Tribune (Nov. 9, 2003); Wondie Russell, “Memorandum re Frederick LeGrande v. J-M Products Corp,”(Nov. 3, 1982).

[44] The Freehold Transcript and The Monmouth Inquirer (Freehold, New Jersey) at 17 (Thurs., Oct. 22, 1959).

[45] Asbestos Worker (July 1957).

[46] The Asbestos Worker at 1 (Oct, 1957) (reporting on the Asbestos Workers’ 19th General Convention).

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

[48] Arthur M. Langer, “Asbestos Studies in the Environmental Sciences Laboratory Mount Sinai School of Medicine 1965 – 1985: Investigations Reflecting State-of-the-Art; Contributions to the Understanding of Asbestos Medicine” (Unpublished MS, Nov. 7, 2008).

[49] Alvin S. Tierstein, A. Gottlieb, Mortimer E. Bader, Richard A. Bader & Irving Selikoff, “Pulmonary mechanics in asbestosis of the lungs,” 8 Clin. Res. 256 (1960); Mortimer E. Bader, Richard A. Bader & Irving Selikoff, “Pulmonary function in asbestosis of the lung; an alveolar-capillary block syndrome, 30 Am. J. Med. 235 (1961).

[50] Asbestos Worker (May 1961) (“The subject matter of Health Hazards was discussed and President Sickles reported on the possibility of an early meeting with people connected with the Medical Association for the purpose of running various tests on certain materials used by our membership in order to determine the extent of their contribution to lung cancer, silicosis, asbestosis, tuberculosis, etc.”).

[51] 15 The Asbestos Worker at 29 (Nov. 1961).

[52] Asbestos Worker (May 1962) (“President Sickles advised the Board as to a meeting which had been held with Vice President Rider and a Dr. Irving Selikoff, of the Paterson Clinic in connection with our issue on Health Hazards and the Committee on Health Hazards with the approval of the Board instructed President Sickles to continue his efforts in this direction.”)

[53] Asbestos Worker at 25 (Feb. 1963).

[54] Capt. H.M. Robbins & William T. Marr, “Asbestosis,” 19 Safety Review 10 (1962) (noting that asbestos dust counts of 200 million particles per cubic foot were not uncommon during insulation ripouts onboard naval vessels).

[55] “Progress Report on Health Hazards,” 16 The Asbestos Worker 25 (Feb. 1963) (the examination were arranged by President Carl Sickles, Vice-President Hugh Mulligan and Vice-President George Rider of the Health Hazards Committee).

[56] Irving J. Selikoff, Jacob Churg, and E. Cuyler Hammond, “Asbestos Exposure and Neoplasia,” 188 J. Am. Med. Ass’n 22 (1964).

[57] Irving J. Selikoff, Jacob Churg, E. Cuyler Hammond, “The Occurrence of Asbestosis among Insulation Workers in the United States,” 132 Ann. N.Y. Acad. Sci. 139, 142 (1965) (“In later specimens so obtained, crocidolite has also been found. Moreover, materials used for ship insulation, while containing the same amounts of asbestos as above, began in 1934 to have significant amounts of amosite in addition to chrysotile, because of the lighter weight of the material.”); Harrington, “Chemical Studies of Asbestos,” 132 Ann. N.Y. Acad. Sci. 31, 41 (1965) (reporting the finding of chrysotile and crocidolite asbestos in equal proportions in specimens of 85% magnesia pipe-covering sections); N.W. Hendry, “The Geology, Occurrences, and Major Uses of Asbestos 132 Annals N.Y. Acad. Sci. 12, 19 (1965) (reporting that, in 1963, the U.S. used  22,000 tons of amosite in manufactured products, and 17,000 tons of crocidolite in acid-resistent filters, packings, insulations, and certain types of lagging. United States Department of Commerce statistics show that for the years 1957 to 1962, more crocidolite was used in the United States than was amosite. In 1962, the use of blue was twice as great as that for brown. 132 Ann. N.Y. Acad. Sci. at 753, Table 17 (1965); see also id. at 762, Table 23 (1965) (South African blue fiber imports exceeded brown fiber imports, starting about 1954). See alsoSelikoff and the Mystery of the Disappearing Amphiboles” (Dec. 10, 2010); James R. Millette, Steven Compton, and Christopher DePasquale, “Microscopical Analyses of Asbestos-Cement Pipe and Board,” 66 The Microscope 3 (2018) (reporting analyses of cement formulations with substantial crocidolite).

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

[59] Jonathan Samet, et al., eds., Institute of Medicine Review of Asbestos: Selected Cancers (2006); see also Richard Doll & Julian Peto, Asbestos: Effects on health of exposure to asbestos 8 (1985) (“In particular, there are no grounds for believing that gastrointestinal cancers in general are peculiarly likely to be caused by asbestos exposure.”).

[60]Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010); see, e.g., Barros v. United States, 147 F.Supp. 340, 343-44 (E.D.N.Y. 1957) (noting that Dr. Selikoff testified for seaman suing for maintenance and cure as a result of a slip and fall; finding for respondent against libelant); DeRienzo v. Passaic Fire Dept., reported in The News (Paterson, New Jersey) at 27 (Feb. 14, 1957) (Selikoff was a witness for the claimant); Bradshaw v. Twin City Insulation Co. Ltd., Indus. Ct. Indiana, Claim No. O.D.1454 (Oct. 14, 1966); Bradshaw v. Johns-Manville Sales Corp., Civ. Action No. 29433, E. D. Mich. S. Div. (July 6, 1967); Bambrick v. Asten Hill Mfg. Co., Pa. Cmwlth. Ct. 664 (1972); Tomplait v. Combustion Engineering Inc.., E. D. Tex. Civ. Action No. 5402 (March 4, 1968); Babcock & Wilcox, Inc. v. Steiner, 258 Md. 468, 471, 265 A.2d 871 (1970) (affirming workman compensation award for asbestosis); Rogers v. Johns-Manville Products Corp., Cir. Ct. Mo., 16th Jud. Cir., Div. 9, Civ. Action No. 720,071 (Feb. 19, 1971); Utter v. Asten-Hill Mfg. Co., 453 Pa. 401 (1973); Karjala v Johns-Manville Products Corp., D. Minn., Civ. Action Nos. 5–71 Civ. 18, and Civ. 40 (Feb. 8, 1973); Culp Industrial Insulation v. Commonwealth of Pennsylvania Workmen’s Compensation Appeal Board, 57 Pa. Commonwealth Ct. 599, 601-602 (1981).

[61] Andrew Haas, Comments from the General President, 18 Asbestos Worker (Nov. 1972); see also Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003) (citing Haas).

[62] Thomas O’Toole, “U.S. Warned of Asbestos Peril,” Wash. Post. A4 (Dec. 4, 1968).

[63]The United States Government’s Role in the Asbestos Mess” (Jan. 31, 2012). See also Kara Franke & Dennis Paustenbach, “Government and Navy knowledge regarding health hazards of Asbestos: A state of the science evaluation (1900 to 1970),” 23(S3) Inhalation Toxicology 1 (2011); Capt. H.M. Robbins & W.T. Marr, “Asbestosis,” Safety Review (Oct. 1962); See also Walter Olson, “Asbestos awareness pre-Selikoff,” (Oct. 19, 2007).

[64] “Green Sheet,” The Asbestos Worker (May 1969).

[65] See Charles E. Rossiter, “Initial repeatability trials of the UICC/Cincinnati classification of the radiographic appearances of pneumoconioses,” 29 Brit. J. Indus. Med. 407 (1972) (among physician readers of chest radiographs, Selikoff was at the extreme of least likely to call a film normal (less than half the average of all readers), and the most likely to interpret films to show excess profusion of small irregular linear densities). SeeSelikoff and the Mystery of the Disappearing Asbestosis” (Dec. 6, 2010). The unions, of course, interested in maximizing compensation for their members loved Selikoff’s over-reading of chest films. Selikoff’s colleagues (Ruth Lilis) routinely teased Selikoff about not being able to read chest radiographs. Selikoff was rumored to have taken and failed the NIOSH B-Reader examination, a rumor which needs to be resolved by a FOIA request.

[66] United States v. Reserve Mining Co. See United States v. Reserve Mining Co., 56 F.R.D. 408 (D.Minn.1972); Armco Steel Corp. v. United States, 490 F.2d 688 (8th Cir. 1974); United States v. Reserve Mining Co., 380 F.Supp. 11 (D.Minn.1974); Reserve Mining Co. v. United States, 498 F.2d 1073 (8th Cir. 1974); Minnesota v. Reserve Mining Co., 418 U.S. 911 (1974); Minnesota v. Reserve Mining Co., 419 U.S. 802 (1974); United States v. Reserve Mining Co., 394 F.Supp. 233 (D.Minn.1974); Reserve Mining Co. v. Environmental Protection Agency, 514 F.2d 492 (8th Cir. 1975); Minnesota v. Reserve Mining Co., 420 U.S. 1000, 95 S.Ct. 1441, 43 L.Ed.2d 758 (1975); Reserve Mining Co. v. Lord, 529 F.2d 181 (8th Cir. 1976); United States v. Reserve Mining Co., 408 F.Supp. 1212 (D.Minn.1976); United States v. Reserve Mining Co., 412 F.Supp. 705 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 789 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 791 (D.Minn.1976); 543 F.2d 1210 (1976).

[67] Robert V. Bartlett, The Reserve Mining Controversy: Science, Technology, and Environmental Quality 140-41 (1980) (describing Selikoff’s testimony).

[68] Jock McCulloch & Geoffrey Tweedale, Defending the Indefensible: The Global Asbestos Industry and its Fight for Survival: The Global Asbestos Industry and its Fight for Survival 95 & n.36 (2008). These authors ignored other reasons Selikoff later stood down from the witness chair: his self-serving insistence upon the importance of his own research detracted from the work of previous authors (e.g., Sir Richard Doll, J. Christopher Wagner, et al.) in litigation of personal injury claims of asbestos health effects. Plaintiffs’ counsel needed to push back the dates of first knowledge of asbestos health effects well before Selikoff’s first insulator study in 1964. The litigation industry needed Selikoff to continue to generate publicity, and to stop testifying. Selikoff surely must have had some concerns about how further testifying would eventually lead to questions about his credentials. Furthermore, Selikoff had an entire generation of younger, less politically visible colleagues at Mt. Sinai to fill the ranks of expert witnesses for the litigation industry (Miller, Levin, Nicholson, Lillis, Daum, Anderson, Frank, et al.).

[69] Obituary for Abraham Selecoff, The Miami Herald (May 22, 1974).

[70] Irving J. Selikoff, “Epidemiology of gastrointestinal cancer,” 9 Envt’l Health Persp. 299 (1974) (arguing for causal conclusion between asbestos and all gastrointestinal cancers).

[71] Nicholas Wade, “The Science and Politics of a Disinvitation,” 201 Science 892 (1978) (commenting that the NCI was negligent in failing to evaluate the ad hominem opinions given to it by Selikoff).

[72] SeeThe Selikoff – Castleman Conspiracy” (Mar. 13, 2011); “What Happens When Historians Have Bad Memories” (Mar. 15, 2014); “Castleman-Selikoff – Can Their Civil Conspiracy Survive Death?” (Dec. 3, 2018). In 2014, Castleman testified that he has no recollection of the memorandum, but he did not deny that had written it.

[73] B.D. Colen, “Knowing When the Chemistry is Right,” Newsday (Suffolk Edition) (Melville, New York) at 85 (Tue., July 29, 1980).

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

[75] Irving Selikoff & William Nicholson, “Mortality Experience of 1,918 Employees of the Electric Boat Company, Groton, Connecticut January 1, 1967 – June 30, 1978” (Jan. 27, 1984).

[76]The Mt. Sinai Catechism” (June 5, 2013).

[77]Irving Selikoff and the Right to Peaceful Dissembling” (June 5, 2013).

[78] Leo H. Caney, “Noted Cancer Researcher Altering Role,” N.Y. Times (Mar. 10, 1985).

[79] Celia Selikoff Social Security Records, SSN 064-12-6401. Celia was born on Sept. 12, 1908.

[80] A New York state trial court initially sided with Selikoff over this subpoena battle. In re R.J. Reynolds Tobacco Co., 136 Misc.2d 282, 518 N.Y.S.2d 729 (N.Y. Sup. Ct., N.Y. Cty. 1987). The federal court subsequently required Selikoff to honor another litigant’s subpoena. In re American Tobacco Co., 866 F.2d 552 (2d Cir. 1989).

[81] William J. Nicholson & Irving J. Selikoff, “Mortality experience of asbestos factory workers; effect of differing intensities of asbestos exposure”: unpublished manuscript produced in litigation (1988) (“[O]ther asbestos varieties (amosite, crocidolite, anthophyllite) were also used for some products. In general, chrysotile was used for textiles, roofing materials, asbestos cements, brake and friction products, fillers for plastics, etc.; chrysotile with or without amosite for insulation materials; chrysotile and crocidolite for a variety of asbestos cement products.”).

[82] 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).

[83] Jack B. Weinstein, “Learning, Speaking, and Acting: What Are the Limits for Judges?” 77 Judicature 322, 326 (May-June 1994) (emphasis added). Judge Weinstein’s false statement that Selikoff “had never testified” 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 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.

[84] Jack B. Weinstein, “Learning, Speaking, and Acting: What Are the Limits for Judges?” 77 Judicature 322, 326 (May-June 1994). The point apparently weighed on Judge Weinstein’s conscience. He repeated his mea culpa almost verbatim, along with the false statement about Selikoff’s never having testified, in a law review article in 1994, and then incorporated the misrepresentation into a full-length book. 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.”).

[85] Social Security records for Irving John Selikoff, social sec. no. 085-16-1882. See Bruce Lambert, “Irving J. Selikoff Is Dead at 77; TB Researcher Fought Asbestos,” N.Y. Times (May 22, 1992).

[86] Steve Markowitz, Stephen Levin, Albert Miller, and Alfredo Morabia, “Asbestos, Asbestosis, Smoking and Lung Cancer: New Findings from the North American Insulator Cohort,” Am. J. Respir. & Critical Care Med. (2013)).

Reference Manual – Desiderata for 4th Edition – Part VI – Rule 703

February 17th, 2023

One of the most remarkable, and objectionable, aspects of the third edition was its failure to engage with Federal Rule of Evidence of 703, and the need for courts to assess the validity of individual studies relied upon. The statistics chapter has a brief, but important discussion of Rule 703, as does the chapter on survey evidence. The epidemiology chapter mentions Rule 703 only in a footnote.[1]

Rule 703 appears to be the red-headed stepchild of the Federal Rules, and it is often ignored and omitted from so-called Daubert briefs.[2] Perhaps part of the problem is that Rule 703 (“Bases of an Expert”) is one of the mostly poorly drafted rules in the Federal Rules of Evidence:

“An expert may base an opinion on facts or data in the case that the expert has been made aware of or personally observed. If experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject, they need not be admissible for the opinion to be admitted. But if the facts or data would otherwise be inadmissible, the proponent of the opinion may disclose them to the jury only if their probative value in helping the jury evaluate the opinion substantially outweighs their prejudicial effect.”

Despite its tortuous wording, the rule is clear enough in authorizing expert witnesses to rely upon studies that are themselves inadmissible, and allowing such witnesses to disclose the studies that they have relied upon, when there has been the requisite showing of probative value that outweighs any prejudice.

The statistics chapter in the third edition, nonetheless, confusingly suggested that

“a particular study may use a method that is entirely appropriate but that is so poorly executed that it should be inadmissible under Federal Rules of Evidence 403 and 702. Or, the method may be inappropriate for the problem at hand and thus lack the ‘fit’ spoken of in Daubert. Or the study might rest on data of the type not reasonably relied on by statisticians or substantive experts and hence run afoul of Federal Rule of Evidence 703.”[3]

Particular studies, even when beautifully executed, are not admissible. And particular studies are not subject to evaluation under Rule 702, apart from the gatekeeping of expert witness opinion testimony that is based upon the particular studies. To be sure, the reference to Rule 703 is important and welcomed counter to the suggestion, elsewhere in the third edition, that courts should not look at individual studies. The independent review of individual studies is occasionally lost in the shuffle of litigation, and the statistics chapter is correct to note an evidentiary concern whether each individual study may or may not be reasonably relied upon by an expert witness. In any event, reasonably relied upon studies do not ipso facto become admissible.

The third edition’s chapter on Survey Research contains the most explicit direction on Rule 703, in terms of courts’ responsibilities.  In that chapter, the authors instruct that Rule 703:

“redirect[ed] attention to the ‘validity of the techniques employed’. The inquiry under Rule 703 focuses on whether facts or data are ‘of a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject’.”[4]

Although Rule 703 is clear enough on admissibility, the epidemiology chapter described epidemiologic studies broadly as admissible if sufficiently rigorous:

“An epidemiologic study that is sufficiently rigorous to justify a conclusion that it is scientifically valid should be admissible, as it tends to make an issue in dispute more or less likely.”[5]

The authors of the epidemiology chapter acknowledge, in a footnote, “that [h]earsay concerns may limit the independent admissibility of the study, but the study could be relied on by an expert in forming an opinion and may be admissible pursuant to Fed. R. Evid. 703 as part of the underlying facts or data relied on by the expert.”[6]

This footnote is curious, and incorrect. There is no question that hearsay “concerns” “may limit” admissibility of a study; hearsay is inadmissible unless there is a statutory exception.[7] Rule 703 is not one of the exceptions to the rule against hearsay in Article VIII of the Federal Rules of Evidence. An expert witness’s reliance upon a study does not make the study admissible. The authors cite two cases,[8] but neither case held that reasonable reliance by expert witnesses transmuted epidemiologic studies into admissible evidence. The text of Rule 703 itself, and the overwhelming weight of case law interpreting and applying the rule,[9]  makes clear that the rule does not render scientific studies admissible. The two cases cited by the epidemiology chapter, Kehm and Ellis, both involved “factual findings” in public investigative or evaluative reports, which were independently admissible under Federal Rule of Evidence 803(8)(C).[10] As such, the cases failed to support the chapter’s suggestion that Rule 703 is a rule of admissibility for epidemiologic studies. The third edition thus, in one sentence, confused Rule 703 with an exception to the rule against hearsay, which would prevent the statistically based epidemiologic studies from being received in evidence. The point was reasonably clear, however, that studies “may be offered” to explain an expert witness’s opinion. Under Rule 705, that offer may also be refused.

The Reference Manual was certainly not alone in advancing the notion that studies are themselves admissible. Other well-respected evidence scholars have misstated the law on this issue.[11] The fourth edition would do well to note that scientific studies, and especially epidemiologic studies, involve multiple levels of hearsay. A typical epidemiologic study may contain hearsay leaps from patient to clinician, to laboratory technicians, to specialists interpreting test results, back to the clinician for a diagnosis, to a nosologist for disease coding, to a national or hospital database, to a researcher querying the database, to a statistician analyzing the data, to a manuscript that details data, analyses, and results, to editors and peer reviewers, back to study authors, and on to publication. Those leaps do not mean that the final results are thus untrustworthy or not reasonably relied upon, but they do raise well-nigh insuperable barriers to admissibility. The inadmissibility of scientific studies is generally not problematic because Rule 703 permits testifying expert witnesses to formulate opinions based upon facts and data, which are not themselves admissible in evidence. The distinction between relied upon, and admissible, studies is codified in the Federal Rules of Evidence, and in virtually every state’s evidence law.

The fourth edition might well also note that under Rule 104(a), the Rules of Evidence themselves do not govern a trial court’s preliminary determination, under Rules 702 or 703, of the admissibility of an expert witness’s opinion, or the appropriateness of reliance upon a particular study. Although Rule 705 may allow disclosure of facts and data described in studies, it is not an invitation to permit testifying expert witnesses to become a conduit for off-hand comments and opinions in the introduction or discussion sections of relied upon articles.[12] The wholesale admission of such hearsay opinions undermines the court’s control over opinion evidence. Rule 703 authorizes reasonable reliance upon “facts and data,” not every opinion that creeps into the published literature.

Reference Manual’s Disregard of Study Validity in Favor of the “Whole Tsumish”

The third edition evidence considerable ambivalence in whether trial judges should engage in resolving disputes about the validity of individual studies relied upon by expert witnesses. Since 2000, Rule 702 clearly required such engagement, which made the Manual’s hesitancy, on the whole, unjustifiable.  The ambivalence with respect to study validity, however, was on full display in the late Professor Margaret Berger’s chapter, “The Admissibility of Expert Testimony.”[13] Berger’s chapter criticized “atomization,” or looking at individual studies in isolation, a process she described pejoratively as “slicing-and-dicing.”[14]

Drawing on the publications of Daubert-critic Susan Haack, Berger appeared to reject the notion that courts should examine the reliability of each study independently.[15] Berger described the “proper” scientific method, as evidenced by works of the International Agency for Research on Cancer (IARC), the Institute of Medicine, the National Institute of Health, the National Research Council, and the National Institute for Environmental Health Sciences, “is to consider all the relevant available scientific evidence, taken as a whole, to determine which conclusion or hypothesis regarding a causal claim is best supported by the body of evidence.”[16]

Berger’s description of the review process, however, was profoundly misleading in its incompleteness. Of course, scientists undertaking a systematic review identify all the relevant studies, but some of the “relevant” studies may well be insufficiently reliable (because of internal or external validity issues) to answer the research question at hand. All the cited agencies, and other research organizations and researchers, exclude studies that are fundamentally flawed, whether as a result of bias, confounding, erroneous data analyses, or related problems. Berger cited no support for her remarkable suggestion that scientists do not make “reliability” judgments about available studies when assessing the “totality of the evidence.”[17]

Professor Berger, who had a distinguished career as a law professor and evidence scholar, died in November 2010, before the third edition was published. She was no friend of Daubert,[18] but her antipathy remarkably outlived her. Berger’s critical discussion of “atomization” cited the notorious decision in Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11, 26 (1st Cir. 2011), which was decided four months after her passing.[19]

Professor Berger’s contention about the need to avoid assessments of individual studies in favor of the whole “tsumish” must also be rejected because Federal Rule of Evidence 703 requires that each study considered by an expert witness “qualify” for reasonable reliance by virtue of the study’s containing facts or data that are “of a type reasonably relied upon by experts in the particular field forming opinions or inferences upon the subject.” One of the deeply troubling aspects of the Milward decision is that it reversed the trial court’s sensible decision to exclude a toxicologist, Dr. Martyn Smith, who outran his headlights on issues having to do with a field in which he was clearly inexperienced – epidemiology.

Another curious omission in the third edition’s discussions of Milward is the dark ethical cloud of misconduct that hovers over the First Circuit’s reversal of the trial court’s exclusions of Martyn Smith and Carl Cranor. On appeal, the Council for Education and Research on Toxics (CERT) filed an amicus brief in support of reversing the exclusion of Smith and Cranor. The CERT amicus brief, however, never disclosed that CERT was founded by Smith and Cranor, and that CERT funded Smith’s research.[20]

Rule 702 requires courts to pay attention to, among other things, the sufficiency of the facts and data relied upon by expert witnesses. Rule 703’s requirement that individual studies must be reasonably relied upon is an important additional protreptic against the advice given by Professor Berger, in the third edition.


[1] The index notes the following page references for Rule 703: 214, 361, 363-364, and 610 n.184.

[2] See David E. Bernstein & Eric G. Lasker,“Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 William & Mary L. Rev. 1, 32 (2015) (“Rule 703 is frequently ignored in Daubert analyses”);  Schachtman, “Rule 703 – The Problem Child of Article VII,” 17 Proof 3 (Spring 2009); Schachtman “The Effective Presentation of Defense Expert Witnesses and Cross-examination of Plaintiffs’ Expert Witnesses”; at the ALI-ABA Course on Opinion and Expert Witness Testimony in State and Federal Courts (February 14-15, 2008). See also Julie E. Seaman, “Triangulating Testimonial Hearsay: The Constitutional Boundaries of Expert Opinion Testimony,” 96 Georgetown L.J. 827 (2008); “RULE OF EVIDENCE 703 — Problem Child of Article VII” (Sept. 19, 2011); “Giving Rule 703 the Cold Shoulder” (May 12, 2012); “New Reference Manual on Scientific Evidence Short Shrifts Rule 703,” (Oct. 16, 2011).

[3] RMSE3d at 214.

[4] RMSE3d at 364 (internal citations omitted).

[5] RMSE 3d at 610 (internal citations omitted).

[6] RSME3d at 601 n.184.

[7] Rule 802 (“Hearsay Rule”) “Hearsay is not admissible except as provided by these rules or by other rules prescribed by the Supreme Court pursuant to statutory authority or by Act of Congress.”

[8] Kehm v. Procter & Gamble Co., 580 F. Supp. 890, 902 (N.D. Iowa 1982) (“These [epidemiologic] studies were highly probative on the issue of causation—they all concluded that an association between tampon use and menstrually related TSS [toxic shock syndrome] cases exists.”), aff’d, 724 F.2d 613 (8th Cir. 1984); Ellis v. International Playtex, Inc., 745 F.2d 292, 303 (4th Cir. 1984). The chapter also cited another the en banc decision in Christophersen for the proposition that “[a]s a general rule, questions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissibility. . . . ” In the Christophersen case, the Fifth Circuit was clearly addressing the admissibility of the challenged expert witness’s opinions, not the admissibility of relied-upon studies. Christophersen v. Allied-Signal Corp., 939 F.2d 1106, 1111, 1113-14 (5th Cir. 1991) (en banc) (per curiam) (trial court may exclude opinion of expert witness whose opinion is based upon incomplete or inaccurate exposure data), cert. denied, 112 S. Ct. 1280 (1992).

[9] Interestingly, the authors of this chapter abandoned their suggestion, advanced in the second edition, that studies relied upon “might qualify for the learned treatise exception to the hearsay rule, Fed. R. Evid. 803(18), or possibly the catchall exceptions, Fed. R. Evid. 803(24) & 804(5).” which was part of their argument in the Second Edition. RMSE 2d at 335 (2000). See also RMSE 3d at 214 (discussing statistical studies as generally “admissible,” but acknowledging that admissibility may be no more than permission to explain the basis for an expert’s opinion, which is hardly admissibility at all).

[10] See Ellis, 745 F.2d at 299-303; Kehm, 724 F.2d at 617-18. These holdings predated the Supreme Court’s 1993 decision in Daubert, and the issue whether they are subject to Rule 702 has not been addressed.  Federal agency factual findings have been known to be invalid, on occasion.

[11] David L. Faigman, et al., Modern Scientific Evidence: The Law and Science of Expert Testimony v.1, § 23:1,at 206 (2009) (“Well conducted studies are uniformly admitted.”).

[12] Montori, et al., “Users’ guide to detecting misleading claims in clinical research reports,” 329 Br. Med. J. 1093, 1093 (2004) (advising readers on how to avoid being misled by published literature, and counseling readers to “Read only the Methods and Results sections; bypass the Discussion section.”)  (emphasis added).

[13] RSME 3d 11 (2011).

[14] Id. at 19.

[15] Id. at 20 & n. 51 (citing Susan Haack, “An Epistemologist in the Bramble-Bush: At the Supreme Court with Mr. Joiner,” 26 J. Health Pol. Pol’y & L. 217–37 (1999).

[16] Id. at 19-20 & n.52.

[17] See Berger, “The Admissibility of Expert Testimony,” RSME 3d 11 (2011).  Professor Berger never mentions Rule 703 at all!  Gone and forgotten.

[18] Professor Berger filed an amicus brief on behalf of plaintiffs, in Rider v. Sandoz Pharms. Corp., 295 F.3d 1194 (11th Cir. 2002).

[19] Id. at 20 n.51. (The editors note that the published chapter was Berger’s last revision, with “a few edits to respond to suggestions by reviewers.”) The addition of the controversial Milward decision cannot seriously be considered an “edit.”

[20]From Here to CERT-ainty” (June 28, 2018); “ THE COUNCIL FOR EDUCATION AND RESEARCH ON TOXICS” (July 9, 2013).

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.