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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 Tenpenny” Tortini (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).

Posted in Expert Witnesses, Public Nuisances, Scientific Evidence, Scientific Misconduct | No Comments »

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).

Posted in Confounding, Peer Review, Scientific Evidence, Scientific Publishing | No Comments »

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).

Posted in Evidence, Scientific Evidence | No Comments »

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. See, e.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).

Posted in Confounding, Reference Manual on Scientific Evidence, Rule 702, Scientific Evidence, Scientific Misconduct, Scientific Publishing | No Comments »

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.

Posted in Evidence, Expert Witnesses, Frye, Rule 702, Rule 703, Scientific Evidence | 1 Comment »

Mass Tortogenesis

January 22nd, 2023

Mass torts are created much as cancer occurs in humans. The multistage model of tortogenesis consists of initiating and promoting events. The model describes, and in some cases, can even predict mass torts. The model also offers insights into prevention.

INITIATION

Initiating events can take a variety of forms. A change in a substance’s categorization in the International Agency for Research on Cancer’s treatment of cancer “hazards” will often initiate a mass tort by stirring interest in the lawsuit industry. A recent example of an IARC pronouncement’s initiating mass tort litigation is its reclassification of glyphosate as a “probable” human carcinogen.  Although the IARC monograph was probably flawed at its inception, and despite IARC’s specifying that its use of “probable” has no quantitative meaning, the IARC glyphosate monograph was a potent initiator of mass tort litigation against the manufacturer of glyphosate.

Regulatory rulemaking will often initiate a mass tort. Asbestos litigation existed as workman’s compensation cases from the 1930s, and as occasional, isolated cases against manufacturers, from the late 1950s.[1] By 1970, federal regulation of asbestos, in both occupational and environmental settings, however, helped create a legal perpetual motion machine that is still running, half a century later.

Publication of studies, especially with overstated results, will frequently initiate a mass tort. In 2007, the New England Journal of Medicine published a poorly done meta-analysis by Dr. Steven Nissen, on the supposed risk of heart attack from the use of rosiglitazone (Avandia).[2] Within days, lawsuits were filed against the manufacturer, GlaxoSmithKline, which ultimately paid over six billion dollars in settlements and costs.[3] Only after the harm of this mass tort was largely complete, the results of a mega-trial, RECORD,[4] became available, and the FDA changed its regulatory stance on rosiglitazone.[5]

More recently, on October 17, 2022, the Journal of the National Cancer Institute, published an observational epidemiologic study, “Use of Straighteners and Other Hair Products and Incident Uterine Cancer.”[6] Within a week or two, lawsuits began to proliferate. The authors were equivocal about their results, refraining from using explicit causal language, but suggesting that specific (phthalate) chemicals were “driving” the association:

“Abstract

Background

Hair products may contain hazardous chemicals with endocrine-disrupting and carcinogenic properties. Previous studies have found hair product use to be associated with a higher risk of hormone-sensitive cancers including breast and ovarian cancer; however, to our knowledge, no previous study has investigated the relationship with uterine cancer.

Methods

We examined associations between hair product use and incident uterine cancer among 33947 Sister Study participants aged 35-74 years who had a uterus at enrollment (2003-2009). In baseline questionnaires, participants in this large, racially and ethnically diverse prospective cohort self-reported their use of hair products in the prior 12 months, including hair dyes; straighteners, relaxers, or pressing products; and permanents or body waves. We estimated adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) to quantify associations between hair product use and uterine cancer using Cox proportional hazard models. All statistical tests were 2-sided.

Results

Over an average of 10.9 years of follow-up, 378 uterine cancer cases were identified. Ever vs never use of straightening products in the previous 12 months was associated with higher incident uterine cancer rates (HR= 1.80, 95% CI = 1.12 to 2.88). The association was stronger when comparing frequent use (> 4 times in the past 12 months) vs never use (HR=2.55, 95% CI = 1.46 to 4.45; P trend=.002). Use of other hair products, including dyes and permanents or body waves, was not associated with incident uterine cancer.

Conclusion

These findings are the first epidemiologic evidence of association between use of straightening products and uterine cancer. More research is warranted to replicate our findings in other settings and to identify specific chemicals driving this observed association.”

The JNCI article might be considered hypothesis generating, but we can observe the article, in real time, initiating a mass tort. A petition for “multi-district litigation” status was filed not long after publication, and the lawsuit industry is jockeying for the inside post in controlling the litigation. Although the authors acknowledged that their findings were “novel,” and required more research, the lawsuit industry did not.

PROMOTION OF INITIATED MASS TORTS

As noted, within days of publication of the JNCI article on hair straighteners and uterine cancer, lawyers filed cases against manufacturers and sellers of hair straighteners. Mass tort litigation is a big business, truly industrial in scale, with its own eco-system of litigation finance, and claim finding and selling. Laws against champerty and maintenance have gone the way of the dodo. Part of the ethos of this eco-system is the constant deprecation of manufacturing industry’s “conflicts of industry,” while downplaying the conflicts of the lawsuit industry.

Here is an example of an email that a lawsuit industry lawyer might have received last month. The emphases below are mine:

“From:  ZZZ

To:  YYYYYYYYY

Date:  12/XX/2022
Subject:  Hair relaxer linked to cancer

Hi,

Here is the latest information on the Hair Relaxer/Straightener tort.

A recent National Institute of Health sister study showed proof that hair straightener products are linked to uterine cancer.

Several lawsuits have been filed against cosmetic hair relaxer companies since the release of the October 2022 NIH study.

The potential plaintiff pool for this case is large since over 50,000 women are diagnosed yearly.

A motion has been filed with the Judicial Panel on Multi District Litigation to have future cases moved to a class action MDL.

There are four cosmetic hair relaxers that are linked to this case so far.  Dark & Lovely, Olive Oil Relaxer, Motions, and Organic Root Stimulator.

Uterine fibroids and endometriosis have been associated with phthalate metabolites used in hair relaxers.

Are you looking to help victims in this case

ZZZ can help your firm sign up these thousands of these claimants monthly with your hair relaxer questionnaire, criteria, retainer agreement, and Hippa without the burden of doing this in house at an affordable cost per signed retainer for intake fees.

  • ZZZ intake fees are as low as $65 dollars per signed based upon a factors which are criteria, lead conversion %, and length of questionnaire.  Conversion rates are averaging 45%.
  • I can help point you in the right direction for reputable marketing agencies if you need lead sources or looking to purchase retainers.  

Please contact me to learn more about how we can help you get involved in this case.

Thank you,

ZZZ”

As you can see from ZZZ’s email, the JNCI article was the tipping point for the start of a new mass tort. ZZZ, however, was a promoter, not an initiator. Consider the language of ZZZ’s promotional efforts:

“Proof”!

As in quod erat demonstrandum.

Where is the Department of Justice when you have the makings of a potential wire fraud case?[7]

And “link.” Like sloppy journalists, the lawsuit industry likes to link a lot.

chorizo sausage links (courtesy of Wikipedia)[8]

And so it goes.

Absent from the promotional email are of course, mentions of the “novelty” of the JNCI paper’s finding, its use of dichotomized variables, its multiple comparisons, or its missing variables. Nor will you see any concern with how the JNCI authors inconsistently ascertained putative risk factors. Oral contraception was ascertained for over 10 years before base line, but hair straightener use was ascertained only for one year prior to baseline.

SYSTEMIC FAILURES TO PREVENT MASS TORTOGENESIS

Human carcinogenesis involves initiation and promotion, as well as failure of normal defense mechanisms against malignant transformation. Similarly, mass tortogenesis involves failure of defense mechanisms. Since 1993, the federal courts have committed to expert witness gatekeeping, by which they exclude expert witnesses who have outrun their epistemic headlights. Gatekeeping in federal court does not always go well, as for example in the Avandia mass tort, discussed above. In state courts, gatekeeping is a very uneven process.

Most states have rules or law that looks similar to federal law, but state judges, not uncommonly, look for ways to avoid their institutional responsibilities. In a recent decision involving claims that baby foods allegedly containing trace metals cause autism, a California trial judge shouted “not my job”[9]:

 “Under California law, the interpretation of epidemiological data — especially data reported in peer-reviewed, published articles — is generally a matter of professional judgment outside the trial court’s purview, including the interpretation of the strengths and weaknesses of a study’s design. If the validity of studies, their strengths and weaknesses, are subject to ‘considerable scientific interpretation and debate’, a court abuses its discretion by ‘stepping in and resolving the debate over the validity of the studies’. Nor can a court disregard ‘piecemeal … individual studies’ because it finds their methodology, ‘fully explained to the scientific community in peer-reviewed journals, to be misleading’ – ‘it is essential that… the body of studies be considered as a whole’. Flaws in study methodology should instead be ‘explored in detail through cross-examination and with the defense expert witnesses’ and affect ‘the weight[,] not the admissibility’ of an expert’s opinions.”

When courts disclaim responsibility for ensuring validity of evidence used to obtain judgments in civil actions, mass tortogenesis is complete, and the victim, the defendants, often must undergo radical treatment.

[1] The first civil action appears to have been filed by attorney William L. Brach on behalf of Frederick LeGrande, against Johns-Manville, for asbestos-related disease, on July 17, 1957, in LeGrande v. Johns-Manville Prods. Corp., No. 741-57 (D.N.J.).

[2] Steven E. Nissen, M.D., and Kathy Wolski, M.P.H., “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” 356 New Engl. J. Med. 2457, 2457 (2007).

[3] In re Avandia Marketing, Sales Practices and Product Liability Litigation, 2011 WL 13576, *12 (E.D. Pa. 2011) (Rufe, J.).  See “Learning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion” (Jan. 10, 2011). Failed expert witness opinion gatekeeping promoted the mass tort into frank mass tort.

[4] Philip D. Home, Stuart J Pocock, et al., “Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD),” 373 Lancet 2125 (2009) (reporting hazard ratios for cardiovascular deaths 0.84 (95% C.I., 0·59–1·18), and for myocardial infarction, 1·14 (95% C.I., 0·80–1·63). See “Revisiting the Avandia Scare: Results from the RECORD Trial” DiaTribe Learn (updated Aug. 14, 2021).

[5] FDA Press Release, “FDA requires removal of certain restrictions on the diabetes drug Avandia” (Nov. 25, 2013). And in December 2015, the FDA abandoned its requirement of a Risk Evaluation and Mitigation Strategy for Avandia. FDA, “Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication – FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)” (Dec. 16, 2015).

[6] Che-Jung Chang, Katie M O’Brien, Alexander P Keil, Symielle A Gaston, Chandra L Jackson, Dale P Sandler, and Alexandra J White, “Use of Straighteners and Other Hair Products and Incident Uterine Cancer,”114 J.Nat’l Cancer Instit. 1636 (2022).

[7] See, e.g., United States v. Harkonen, 2010 WL 2985257, at *5 (N.D. Calif. 2010) (denying defendant’s post–trial motions to dismiss the indictment, for acquittal, or for a new trial), aff’d, 510 Fed. Appx. 633, 2013 WL 782354, 2013 U.S. App. LEXIS 4472 (9th Cir. March 4, 2013), cert. denied 134 S.Ct. 824 (2013).

[8] See https://en.wikipedia.org/wiki/List_of_sausages.

[9] NC v Hain Celestial Group, Inc., 21STCV22822, Slip op. sur motion to exclude expert witnesses, Cal. Super. Ct. (Los Angeles May 24, 2022) (internal citations omitted).

Posted in Public Nuisances, Rule 702, Scientific Evidence, Scientific Publishing | 2 Comments »

Doctor Moline – Why Can’t You Be True?

December 18th, 2022

Doctor Moline, why can’t you be true?

Oh, Doc Moline, why can’t you be true?

You done started doing the things you used to do.

Mass torts are the product of the lawsuit industry, and since the 1960s, this industry has produced tort claims on a truly industrial scale. The industry now has an economic ally and adjunct in the litigation finance industry, and it has been boosted by the desuetude of laws against champerty and maintenance. The way that mass torts are adjudicated in some places could easily be interpreted as legalized theft.

One governor on the rapaciousness of the lawsuit industry has been the requirement that claims actually be proven in court. Since the Supreme Court’s ruling in Daubert, the defense bar has been able, on notable occasions, to squelch some instances of false claiming. Just as equity often varies with the length of the Chancellor’s foot, gatekeeping of scientific opinion about causation often varies with the scientific acumen of the trial judge. From the decision in Daubert itself, gatekeeping has been under assault form the lawsuit industry and its allies. I have, in these pages, detailed the efforts of the now defunct Project on Scientific Knowledge and Public Policy (SKAPP) to undermine any gatekeeping of scientific opinion testimony for scientific or statistical validity. SKAPP, as well as other organizations, and some academics, in aid of the lawsuit industry, have lobbied for the abandonment of the requirement of proving causation, or for the dilution of the scientific standards for expert opinions of causation.[1] The counter to this advocacy has been, and continues to be, an insistence that the traditional elements of a case, including general and specific causation, be sufficiently proven, with opinion testimony that satisfies the legal knowledge requirement for such testimony.

Alas, expert witness testimony can go awry in other ways besides merely failing to satisfy the validity and relevance requirements of the law of evidence.[2] One way I had not previously contemplated is suing for defamation or “product disparagement.”

We are now half a century since occupational exposures to various asbestos fibers came under general federal regulatory control, with regulatory requirements that employers warn their employees about the hazards involved with asbestos exposure. This federally enforced dissemination of information about asbestos hazards created a significant problem for the asbestos lawsuit industry.  Cases of mesothelioma have always occurred among persons non-occupationally exposed to asbestos, but as occupational exposure declined, the relative proportion of mesothelioma cases with no obvious occupational exposures increased. The lawsuit industry could not stand around and let these tragic cases go to waste.

Cosmetic talc variably has some mineral particulate that comes under the category of “elongate mineral particles,” (EMP), which the lawsuit industry could assert is “asbestos.” As a result, this industry has been able to reprise asbestos litigation into a new morality tale against cosmetic talc producers and sellers. LTL Management LLC was formerly known as Johnson & Johnson Consumer Inc. [J&J], a manufacturer and seller of cosmetic talc. J&J became a major target of the lawsuit industry in mesothelioma (and ovarian cancer) cases, based upon claims that EMP/asbestos in cosmetic talc caused their cancers. The lawsuit industry recruited its usual retinue of expert witnesses to support its litigation efforts.

Standing out in this retinue was Dr. Jacqueline Moline. On December 16, J&J did something that rarely happens in the world of mass torts; it sued Dr. Moline for fraud, injurious falsehood and product disparagement, and violations of the Lanham Act (§ 43(a), 15 U.S.C. § 1125(a)).[3] The gravamen of the complaint is that Dr. Moline, in 2020, published a case series of 33 persons who supposedly used cosmetic talc products and later developed malignant mesothelioma. According to her article, the 33 patients had no other exposures to asbestos, which she concluded, showed that cosmetic talc use can cause mesothelioma:

“Objective: To describe 33 cases of malignant mesothelioma among individuals with no known asbestos exposure other than cosmetic talcum powder.

Methods: Cases were referred for medico-legal evaluation, and tissue digestions were performed in some cases. Tissue digestion for the six ases described was done according to standard methodology.

Results: Asbestos of the type found in talcum powder was found in all six cases evaluated. Talcum powder usage was the only source of asbestos for all 33 cases.

Conclusions: Exposure to asbestos-contaminated talcum powders can cause mesothelioma. Clinicians should elicit a history of talcum powder usage in all patients presenting with mesothelioma.”[4]

Jacqueline Moline and Ronald Gordon both gave anemic conflicts disclosures: “Authors J.M. and R.G. have served as expert witnesses in asbestos litigation, including talc litigation for plaintiffs.”[5] Co-author Maya Alexandri was a lawyer at the time of publication; she is now a physician practicing emergency medicine, and also a fabulist. The article does not disclose the nature of Dr. Alexandri’s legal practice.

Dr. Moline is a professor and chair of occupational medicine at the Zucker School of Medicine at Hofstra/Northwell. She received her medical degree from the University of Chicago-Pritzker School of Medicine and a Master of Science degree in community medicine from the Mount Sinai School of Medicine. She completed a residency in internal medicine at Yale New Haven Hospital and an occupational and environmental medicine residency at Mount Sinai Medical Center. Dr. Moline is also a major-league testifier for the lawsuit industry.  Over the last quarter century, she has testified from sea to shining sea, for plaintiffs in asbestos, talc, and other litigations.[6]

According to J&J, Dr. Moline was listed as an expert witness for plaintiff, in over 200 talc mesothelioma cases against J&J.  There are, of course, other target defendants in this litigation, and the actual case count is likely higher. Moline has testified in 46 talc cases against J&J, and she has testified in 16 of those cases.[7] J&J estimates that she has made millions of dollars in service of the lawsuit industry.[8]

The authors’ own description of the manuscript makes clear the concern over the validity of personal and occupational histories of the 33 cases: “This manuscript is the first to describe mesothelioma among talcum powder consumers. Our case study suggest [sic] that cosmetic talcum powder use may help explain the high prevalence of idiopathic mesothelioma cases, particularly among women, and stresses the need for improved exposure history elicitation among physicians.”[9]

The Complaint alleges that Moline knew that her article, testimony, and public statements about the absence of occupational asbestos exposure in subjects of her case series, were false.  After having her testimony either excluded by trial courts, or held on appeal to be legally insufficient,[10] Moline set out to have a peer-reviewed publication that would support her claims. Because mesothelioma is sometimes considered, uncritically, as pathognomonic of amphibole asbestos exposure, Moline was obviously keen to establish the absence of occupational exposure in any of the 33 cases.

Alas, the truth appears to have caught up with Moline because some of the 33 cases were in litigation, in which the detailed histories of each case would be discovered. Defense counsel sought to connect the dots between the details of each of the 33 cases and the details of pending or past lawsuits. The federal district court decision in the case of Bell v. American International Industries blew open the doors of Moline’s alleged fraud.[11]  Betty Bell claimed that her use of cosmetic talc had caused her to develop mesothelioma. What Dr. Moline and Bell’s counsel were bound to have known was that Bell had had occupational exposure to asbestos. Before filing a civil action against talc product suppliers, Bell filed workers’ compensation against two textile industry employers.[12] Judge Osteen’s opinion in Bell documents the anxious zeal that plaintiffs’ counsel brought to bear in trying to suppress the true nature of Ms. Bell’s exposure. After Judge Osteen excoriated Moline and plaintiffs’ counsel for their efforts to conceal information about Bell’s occupational asbestos exposures, and about her inclusion in the 33 case series, plaintiffs’ counsel dismissed her case.

Another of the 33 cases was the New Jersey case brought by Stephen Lanzo, for whom Moline testified as an expert witness.[13] In the course of the Lanzo case, the defense developed facts of Mr. Lanzo’s prior asbestos exposure.  Crocidolite fibers were found in his body, even though the amphibole crocidolite is not a fiber type found in talc. Crocidolite is orders of magnitude more potent in causing human mesotheliomas than other asbestos fiber types.[14] Despite these facts, Dr. Moline appears to have included Lanzo as one of the 33 cases in her article.

And then there were others, too.

[1] See “Skappology” (May 26, 2020);  “SKAPP A LOT” (April 30, 2010); “Manufacturing Certainty” (Oct. 25, 2011); “David Michaels’ Public Relations Problem” (Dec. 2, 2011); “Conflicted Public Interest Groups” (Nov. 3, 2013).

[2] See, e.g., “Legal Remedies for Suspect Medical Science in Products Cases – Part One” (June 2, 2020); “Part Two” (June 3, 2020); “Part Three” (June 5, 2020); “Part 4” (June 7, 2020); “Part 5” (June 8, 2020).

[3] LTL Management LLC v. Dr. Jacqueline Miriam Moline,

Adv. Proc. No. 22- ____, in Chap. 11, Case No. 21-30589, Bankruptcy Ct., D.N.J. (Dec. 16, 2022) [Complaint]

[4] Jacqueline Moline, Kristin Bevilacqua, Maya Alexandri, and Ronald E. Gordon, “Mesothelioma Associated with the Use of Cosmetic Talc,” 62 J. Occup. & Envt’l Med. 11 (Jan. 2020) (emphasis added) [cited as Moline]

[5] Dr. Gordon has had other litigation activities of interest. See William C. Rempel, “Alleged Mob Case May Best Illustrate How Not to Play the Game : Crime: Scheme started in a Texas jail and ended with reputed mobsters charged in $30-million laundering scam,” L.A. Times (July 4, 1993).

[6] See., e.g., Fowler v. Akzo Nobel Chemicals, Inc., 251 N.J. 300, 276 A. 3d 1146 (2022); Lanzo v. Cyprus Amax Minerals Co., 467 N.J. Super. 476, 254 A.3d 691 (App. Div. 2021); Fishbain v. Colgate-Palmolive Co., No. A-1786-15T2 (N.J. App. Div. 2019); Buttitta v. Allied Signal, Inc., N.J. App. Div. (2017); Kaenzig v. Charles B. Chrystal Co., N.J. App. Div. (2015); Anderson v. A.J. Friedman Supply Co., 416 N.J. Super. 46, 3 A.3d 545 (App. Div. 2010); Cioni v. Avon Prods., Inc., 2022 NY Slip Op 33197(U) (2022); Zicklin v. Bergdorf Goodman Inc., 2022 NY Slip Op 32119(U) (N.Y.Sup. N.Y. Cty. 2022); Nemeth v. Brenntag North America, 183 A.D.3d 211, 123 N.Y.S.3d 12 (2020), rev’d, 38 N.Y.3d 336, 345 (2022) (Moline’s testimony insufficient); Olson v. Brenntag North America, Inc., 2020 NY Slip Op 33741(U) (N.Y.Sup. N.Y. Cty. 2020), rev’d, 207 A.D.3d 415, 416 (N.Y. 1st Dep’t 2022) (holding Moline’s testimony on causation insufficient).; Moldow v. A.I. Friedman, L.P., 2019 NY Slip Op 32060(U) (N.Y.Sup. N.Y. Cty. 2019); Zoas v BASF Catalysts, LLC., 2018 NY Slip Op 33009(U) (N.Y.Sup. N.Y. Cty. 2018); Prokocimer v. Avon Prods., Inc., 2018 NY Slip Op 33170(U) (Dec. 11, 2018); Shulman v. Brenntag North America, Inc., 2018 NY Slip Op 32943(U) (N.Y.Sup. N.Y. Cty. 2018); Pistone v. American Biltrite, Inc., 2018 NY Slip Op 30851(U) (2018); Evans v. 3M Co., 2017 NY Slip Op 30756(U) (N.Y.Sup. N.Y. Cty. 2017); Juni v. A.O. Smith Water Prods., 48 Misc.3d 460, 11 N.Y.S.3d 416 (2015), aff’d, 32 N.Y.3d 1116, 116 N.E.3d 75, 91 N.Y.S.3d 784 (2018); Konstantin v. 630 Third Ave. Associates, 121 A.D. 3d 230, 990 N.Y.S. 2d 174 (2014); Lopez v. Gem Gravure Co., 50 A.D.3d 1102, 858 N.Y.S.2d 226 (2008); Lopez v. Superflex, Ltd., 31 A.D. 3d 914, 819 N.Y.S. 2d 165 (2006); DeMeyer v. Advantage Auto, 9 Misc. 3d 306, 797 N.Y.S.2d 743 (2005); Amorgianos v. National RR Passenger Corp., 137 F. Supp. 2d 147 (E.D.N.Y. 2001), aff’d, 303 F. 3d 256 (2d Cir. 2002); Chapp v. Colgate-Palmolive Co., 2019 Wisc. App. 54, 935 N.W.2d 553 (2019); McNeal v. Whittaker, Clark & Daniels, Inc., 80 Cal. App. 853 (2022); Burnett v. American Internat’l Indus., Case No. 3:20-CV-3046 (W.D. Ark. Jan. 27, 2022); McAllister v. McDermott, Inc., Civ. Action No. 18-361-SDD-RLB (M.D.La. Aug. 14, 2020); Hanson v. Colgate-Palmolive Co., 353 F. Supp. 3d 1273 (S.D. Ga. 2018); Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135 F. 3d 1260 (9th Cir. 1998); Carroll v. Akebono Brake Corp., 514 P. 3d 720 (Wash. App. 2022).

[7] Complaint ¶15.

[8] Complaint ¶19.

[9] Moline at 11.

[10] See, e.g., In re New York City Asbestos Litig. (Juni), 148 A.D.3d 233, 236-37, 239 (N.Y. App. Div. 1st Dep’t 2017), aff’d, 2 N.Y.3d 1116, 1122 (2018); Nemeth v. Brenntag North America, 183 A.D.3d 211, 123 N.Y.S.3d 12 (N.Y. App. Div. 2020), rev’d, 38 N.Y.3d 336, 345 (2022); Olson v. Brenntag North America, Inc., 2020 NY Slip Op 33741(U) (N.Y.Sup. Ct. N.Y. Cty. 2020), rev’d, 207 A.D.3d 415, 416 (N.Y. App. Div. 1st Dep’t 2022).

[11] Bell v. American Internat’l Indus. et al., No. 1:17-CV-00111, 2022 U.S. Dist. LEXIS 199180 (M.D.N.C. Sept. 13, 2022) (William Lindsay Osteen, Jr., J.). See Daniel Fisher, “Key talc/cancer study cited by plaintiffs hid evidence of other exposure, lawyers say” (Dec. 1, 2022).

[12] According to the Complaint against Moline, Bell had filed workers’ compensation claims with the North Carolina Industrial Commission, back in 2015, declaring under oath that she had been exposed to asbestos while working with two textile manufacturing employers, Hoechst Celanese Corporation and Pillowtex Corporation. Complaint at ¶102. As frequently happens in civil actions, the claimant dismisses worker’s compensation without prejudice, to pursue the more lucrative payday in a civil action, without the burden of employers’ liens against the recovery. Complaint at 102.

[13] See “New Jersey Appellate Division Calls for Do-Over in Baby Powder Dust Up” (May 22, 2021).

[14] David H. Garabrant & Susan T. Pastula, “A comparison of asbestos fiber potency and elongate mineral particle (EMP) potency for mesothelioma in humans,” 361 Toxicology & Applied Pharmacol. 127 (2018) (“relative potency of chrysotile:amosite:crocidolite was 1:83:376”). See also D. Wayne Berman & Kenny S. Crump, “Update of Potency Factors for Asbestos-Related Lung Cancer and Mesothelioma,” 38(S1) Critical Reviews in Toxicology 1 (2008).

Posted in Expert Witness Discovery, Expert Witnesses, Rule 702, Scientific Evidence, Scientific Misconduct, Underlying Data | 23 Comments »

An Opinion to SAVOR

November 11th, 2022

The saxagliptin medications are valuable treatments for type 2 diabetes mellitus (T2DM). The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) study was a randomized controlled trial, undertaken by manufacturers at the request of the FDA.[1] As a large (over sixteen thousand patients randomized) double-blinded cardiovascular outcomes trial, SAVOR collected data on many different end points in patients with T2DM, at high risk of cardiovascular disease, over a median of 2.1 years. The primary end point was a composite end point of cardiac death, non-fatal myocardial infarction, and non-fatal stroke. Secondary end points included each constituent of the composite, as well as hospitalizations for heart failure, coronary revascularization, or unstable angina, as well as other safety outcomes.

The SAVOR trial found no association between saxagliptin use and the primary end point, or any of the constituents of the primary end point.  The trial did, however, find a modest association between saxagliptin and one of the several secondary end points, hospitalization for heart failure (hazard ratio, 1.27; 95% C.I., 1.07 to 1.51; p = 0.007). The SAVOR authors urged caution in interpreting their unexpected finding for heart failure hospitalizations, given the multiple end points considered.[2] Notwithstanding the multiplicity, in 2016, the FDA, which does not require a showing of causation for adding warnings to a drug’s labeling, added warnings about the “risk” of hospitalization for heart failure from the use of saxagliptin medications.

And the litigation came.

The litigation evidentiary display grew to include, in addition to SAVOR, observational studies, meta-analyses, and randomized controlled trials of other DPP-4 inhibitor medications that are in the same class as saxagliptin. The SAVOR finding for heart failure was not supported by any of the other relevant human study evidence. The lawsuit industry, however, armed with an FDA warning, pressed its cases. A multi-district litigation (MDL 2809) was established. Rule 702 motions were filed by both plaintiffs’ and defendants’ counsel.

When the dust settled in this saxagliptin litigation, the court found that the defendants’ expert witnesses satisfied the relevance and reliability requirements of Rule 702, whereas the proferred opinions of plaintiff’s expert witness, Dr. Parag Goyal, a cardiologist at Cornell-Weill Hospital in New York, did not satisfy Rule 702.[3] The court’s task was certainly made easier by the lack of any other expert witness or published opinion that saxagliptin actually causes heart failure serious enough to result in hospitalization. 

The saxagliptin litigation presented an interesting array of facts for a Rule 702 show down. First, there was an RCT that reported a nominally statistically significant association between medication use and a harm, hospitalization for heart failure. The SAVOR finding, however, was in a secondary end point, and its statistical significance was unimpressive when considered in the light of the multiple testing that took place in the context of a cardiovascular outcomes trial.

Second, the heart failure increase was not seen in the original registration trials. Third, there was an effort to find corroboration in observational studies and meta-analyses, without success. Fourth, there was no apparent mechanism for the putative effect. Fifth, there was no support from trials or observational studies of other medications in the class of DPP-4 inhibitors.

Dr. Goyal testified that the heart failure finding in SAVOR “should be interpreted as cause and effect unless there is compelling evidence to prove otherwise.” On this record, the MDL court excluded Dr. Goyal’s causation opinions. Dr. Goyal purported to conduct a Bradford Hill analysis, but the MDL court appeared troubled by his glib dismissal of the threat to validity in SAVOR from multiple testing, and his ignoring the consistency prong of the Hill factors. SAVOR was the only heart failure finding in humans, with the remaining observational studies, meta-analyses, and other trials of DPP-4 inhibitors failing to provide supporting evidence.

The challenged defense expert witnesses defended the validity of their opinions, and ultimately the MDL court had little concern in permitting them through the judicial gate. The plaintiffs’ challenges to Suneil Koliwad, a physician with a doctorate in molecular physiology, Eric Adler, a cardiologist, and Todd Lee, a pharmaco-epidemiologist, were all denied. The plaintiffs challenged, among other things, whether Dr. Adler was qualified to apply a Bonferroni correction to the SAVOR results, and whether Dr. Lee was obligated to obtain and statistically analyze the data from the trials and studies ab initio. The MDL court quickly dispatched these frivolous challenges.

The saxagliptin MDL decision is an important reminder that litigants should remain vigilant about inaccurate assertions of “statistical significance,” even in premier, peer-reviewed journals. Not all journals are as careful as the New England Journal of Medicine in requiring qualification of claims of statistical significance in the face of multiple testing.

One legal hiccup in the court’s decision was its improvident citation to Daubert, for the proposition that the gatekeeping inquiry must focus “solely on principles and methodology, not on the conclusions they generate.”[4] That piece of obiter dictum did not survive past the Supreme Court’s 1997 decision in Joiner,[5] and it was clearly superseded by statute in 2000. Surely it is time to stop citing Daubert for this dictum.

[1] Benjamin M. Scirica, Deepak L. Bhatt, Eugene Braunwald, Gabriel Steg, Jaime Davidson, et al., for the SAVOR-TIMI 53 Steering Committee and Investigators, “Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus,” 369 New Engl. J. Med. 1317 (2013).

[2] Id. at 1324.

[3] In re Onglyza & Kombiglyze XR Prods. Liab. Litig., MDL 2809, 2022 WL 43244 (E.D. Ken. Jan. 5, 2022).

[4] Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 595 (1993).

[5] General Electric Co. v. Joiner, 522 U.S. 136 (1997).

Posted in Causation, Meta-analysis, Rule 702, Scientific Evidence, statistical evidence | No Comments »

Further Thoughts on Cheng’s Consensus Rule

October 3rd, 2022

In “Cheng’s Proposed Consensus Rule for Expert Witnesses,”[1] I discussed a recent law review article by Professor Edward K. Cheng,[2] who has proposed dispensing with expert witness testimony as we know it in favor of having witnesses tell juries what the scientific consensus is on any subject. Cheng’s project is fraught with difficulties and contradictions; and it has clearly anticipatable bad outcomes. Four Supreme Court cases (Daubert, Joiner, Kumho Tire, and Weisgram), and a major revision in Rule 702, ratified by Congress, all embraced the importance of judicial gatekeeping of expert witness opinion testimony to the fact-finding function of trials. Professor Cheng now wants to ditch the entire notion of gatekeeping, as well as the epistemic basis – sufficient facts and data – for expert witnesses’ opinions in favor of reportage of which way the herd is going. Cheng’s proposal is perhaps the most radical attack, in recent times, on the nature of legal factfinding, whether by judges or juries, in the common law world.

Still, there are two claims within his proposal, which although overstated, are worth further discussion and debate. The first is that the gatekeeping role does not sit well with many judges. We see judges ill at ease in their many avoidance tactics, by which they treat serious methodological challenges to expert witness testimony as “merely going to the weight of the conclusion.” The second is that many judges, and especially juries, are completely at sea in the technical knowledge needed to evaluate the scientific issues in many modern day trials.

With respect to the claimed epistemic incompetence, the simpler remedy is to get rid of incompetent judges. We have commercial courts, vaccine courts, and patent courts. Why are litigants disputing a contract or a commercial practice entitled to epistemically competent judges, but litigants in health claim cases are not? Surely, the time has come to have courts with judges that have background and training in the health and statistical sciences. The time for “blue ribbon” juries of properly trained fact finders seems overdue. Somehow we must reconcile the seventh amendment right to a jury with the requirement of “due process” of law. The commitment to jury trials for causes of action known to the common law in 1787, or 1791, is stretched beyond belief for the sorts of technical and complex claims now seen in federal courts and state courts of general jurisdiction.[3]

Several courts have challenged the belief that the seventh amendment right to a jury applies in the face of complex litigation. The United States Court of Appeals explained its understanding of complexity that should remove a case from the province of the seventh amendment:

“A suit is too complex for a jury when circumstances render the jury unable to decide in a proper manner. The law presumes that a jury will find facts and reach a verdict by rational means. It does not contemplate scientific precision but does contemplate a resolution of each issue on the basis of a fair and reasonable assessment of the evidence and a fair and reasonable application of the relevant legal rules. See Schulz v. Pennsylvania RR, 350 U.S. 523, 526 (1956). A suit might be excessively complex as a result of any set of circumstances which singly or in combination render a jury unable to decide in the foregoing rational manner. Examples of such circumstances are an exceptionally long trial period and conceptually difficult factual issues.”[4]

The Circuit’s description of complexity certainly seems to apply to many contemporary claims of health effects.

We should recognize that Professor Cheng’s indictment, and conviction, of judicial gatekeeping and jury decision making as epistemically incompetent directly implies that the judicial process has no epistemic, truth finding function in technical cases of claimed health effects. Cheng’s proposed solution does not substantially ameliorate this implication, because consensus statements are frequently absent, and even when present, are plagued with their own epistemic weaknesses.

Consider for instance, the 1997 pronouncement of the International Agency for Research on Cancer that crystalline silica is a “known” human carcinogen.[5] One of the members of the working group responsible for the pronouncement explained:

“It is hardly surprising that the Working Group had considerable difficulty in reaching a decision, did not do so unanimously and would probably not have done so at all, had it not been explained that we should be concerned with hazard identification, not risk.”[6]

And yet, within months of the IARC pronouncement, state and federal regulatory agencies formed a chorus of assent to the lung cancer “risk” of crystalline silica. Nothing in the scientific record had changed except the permission of the IARC to stop thinking critically about the causation issue. Another consensus group came out, a few years after the IARC pronouncement, with a devastating critical assessment of the IARC review:

“The present authors believe that the results of these studies [cited by IARC] are inconsistent and, when positive, only weakly positive. Other, methodologically strong, negative studies have not been considered, and several studies viewed as providing evidence supporting the carcinogenicity of silica have significant methodological weaknesses. Silica is not directly genotoxic and is a pulmonary carcinogen only in the rat, a species that seems to be inappropriate for assessing particulate carcinogenesis in humans. Data on humans demonstrate a lack of association between lung cancer and exposure to crystalline silica. Exposure-response relationships have generally not been found. Studies in which silicotic patients were not identified from compensation registries and in which enumeration was complete did not support a causal association between silicosis and lung cancer, which further argues against the carcinogenicity of crystalline silica.”[7]

Cheng’s proposal would seem to suppress legitimate courtroom criticism of an apparent consensus statement, which was based upon a narrow majority of a working group, on a controversial dataset, with no examination of the facts and data upon which the putative consensus statement was itself based.

The Avandia litigation tells a cautionary tale of how fragile and ephemeral consensuses can be. A dubious meta-analysis by a well-known author received lead article billing in an issue of the New England Journal of Medicine, in 2007, and litigation claims started to roll in within hours.[8] In face of this meta-analysis, an FDA advisory committee recommended heightened warnings, and a trial court declined to take a careful look at the methodological flaws in the inciting meta-analytic study.[9] Ultimately, a large clinical trial exculpated the medication, but by then the harm had been done, and there was no revisiting of the gatekeeping decision to allow the claims to proceed.[10] The point should be obvious. In 2007, there appeared to be a consensus, with led to an FDA label change, despite the absence of sufficient facts and data to support the litigation claims. Even if plaintiffs’ claims passed through the gate in 2008, they were highly vulnerable to courtroom challenges to the original meta-analysis. Cheng’s proposal, however, would truncate the litigation process into an exploration whether or not there was a “consensus.”

Deviation from Experts’ Standards of Care

The crux of many Rule 702 challenges to an expert witness is that the witness has committed malpractice in his discipline. The challenger must identify a standard of care, and the challenged witness’s deviation(s) from that standard. The identification of the relevant standard of care will, indeed, sometimes involve a consensus, evidenced by texts, articles, professional society statements, or simply implicit in relevant works of scholarship or scientific studies. Consensuses about standards of care are, of course, about methodology. Consensuses about conclusions, however, may also be relevant because if a litigant’s expert witness proffers a conclusion at odds with consensus conclusions, the deviant conclusion implies deviant methodology.

Cheng’s treatment of statistical significance is instructive for how his proposal would create mischief in many different types of adjudications, but especially of claimed health effects. First, Cheng’s misrepresentation of consensus among statisticians is telling for the validity of his project.  After all, he holds an advanced degree in statistics, and yet, he is willing write that that:

“[w]hile historically used as a rule of thumb, statisticians have now concluded that using the 0.05 [p-value] threshold is more distortive than helpful.”[11]

Statisticians, without qualification! And as was shown, Cheng is demonstrably wrong in his use of the cited source to support his representation of what certainly seems like a consensus paper. His précis is not even remotely close to the language of the paper, but the consensus paper is hearsay and can only be used by an expert witness in support of an opinion.  Presumably, another expert witness might contradict the quoted opinion about what “statisticians” have concluded, but it is unclear whether a court could review the underlying A.S.A. paper, take judicial notice of the incorrectness of the proffered opinion, and then exclude the expert witness opinion.

After the 2016 publication of the A.S.A.’s consensus statement, some statisticians did indeed publish editorials claiming it was time to move beyond statistical significance testing. At least one editorial, by an A.S.A. officer was cited as representing an A.S.A. position, which led the A.S.A. President to appoint a task force to consider the call for an across-the-board rejection of significance testing. In 2021, that task force clearly endorsed significance testing as having a continued role in statistical practice.[12]

Where would this situation leave a gatekeeping court or a factfinding jury? Some obscure psychology journals have abandoned the use of significance testing, but the New England Journal of Medicine has retained the practice, while introducing stronger controls for claims of “significance” when the study at hands has engaged in multiple comparisons.

But Cheng, qua law professor and statistician (and would-be expert witness) claims “statisticians have now concluded that using the 0.05 [p-value] threshold is more distortive than helpful,” and the trial must chase not the validity of the inference of claimed causation but whether there is, or is not, a census about the use of a pre-specified threshold for p-values or confidence intervals. Cheng’s proposal about consensuses would turn trials into disputes about whether consensuses exist, and the scope of the purported agreement, not about truth.

In some instances, there might be a clear consensus, fully supported, on a general causation issue. Consider for instance, the known causal relationship between industrial benzene exposure and acute myelogenous leukemia (AML). This consensus turns out to be rather unhelpful when considering whether minute contamination of carbonated water can cause cancer,[13] or even whether occupational exposure to gasoline, with its low-level benzene (~1%) content, can cause AML.[14]

Frequently, there is also a deep asymmetry in consensus statements. When the evidence for a causal conclusion is very clear, professional societies may weigh in to express their confident conclusions about the existence of causation. Such societies typically do not issue statements that explicitly reject causal claims. The absence of a consensus statement, however, often can be taken to represent a consensus that professional societies do not endorse causal claims, and consider the evidence, at best, equivocal. Those dogs that have not barked can be, and have been, important considerations in gatekeeping.

Contrary to Cheng’s complete dismissal of judges’ epistemic competence, judges can, in many instances, render reasonable gatekeeping decisions by closely considering the absence of consensus statements, or systematic reviews, favoring the litigation claims.[15] At least in this respect, Professor Cheng is right to emphasize the importance of consensus, but he fails to note the importance of its absence, and the ability of litigants and their expert witnesses to inform gatekeeping judges of the relevance of consensus statements or their absence to the epistemic assessment of proferred expert witness opinion testimony.

[1] “Cheng’s Proposed Consensus Rule for Expert Witnesses,” (Sept. 15, 2022).

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

[3] There is an extensive discussion and debate of viability and the validity of asserting rights to trial by jury for many complex civil actions in the modern era. See, e.g., Stephan Landsman & James F. Holderman, “The Evolution of the Jury Trial in America,” 37 Litigation 32 (2010); Robert A. Clifford, “Deselecting the Jury in a Civil Case,” 30 Litigation 8 (Winter 2004); Hugh H. Bownes, “Should Trial by Jury Be Eliminated in Complex Cases,” 1 Risk 75 (1990); Douglas King, “Complex Civil Litigation and the Seventh Amendment Right to a Jury Trial,” 51 Univ. Chi. L. Rev. 581 (1984); Alvin B. Rubin, “Trial by Jury in Complex Civil Cases: Voice of Liberty or Verdict by Confusion?” 462 Ann. Am. Acad. Political & Social Sci. 87 (1982); William V. Luneburg & Mark A. Nordenberg, “Specially Qualified Juries and Expert Nonjury Tribunals: Alternatives for Coping with the Complexities of Modern Civil Litigation,” 67 Virginia L. Rev. 887 (1981); Richard O. Lempert, “Civil Juries and Complex Cases: Let’s Not Rush to Judgment,” 80 Mich. L. Rev. 68 (1981); Comment, “The Case for Special Juries in Complex Civil Litigation,” 89 Yale L. J. 1155 (1980); James S. Campbell & Nicholas Le Poidevin, “Complex Cases and Jury Trials: A Reply to Professor Arnold,” 128 Univ. Penn. L. Rev. 965 (1980); Barry E. Ungar & Theodore R. Mann, “The Jury and the Complex Civil Case,” 6 Litigation 3 (Spring 1980); Morris S. Arnold, “A Historical Inquiry into the Right to Trial by Jury in Complex Civil Litigation,”128 Univ. Penn. L. Rev. 829 (1980); Daniel H. Margolis & Evan M. Slavitt, “The Case Against Trial by Jury in Complex Civil Litigation,” 7 Litigation 19 (1980); Montgomery Kersten, “Preserving the Right to Jury Trial in Complex Civil Cases,” 32 Stanford L. Rev. 99 (1979); Maralynne Flehner, “Jury Trials in Complex Litigation,” 4 St. John’s Law Rev. 751 (1979); Comment, “The Right to a Jury Trial in Complex Civil Litigation,” 92 Harvard L. Rev. 898 (1979); Kathy E. Davidson, “The Right to Trial by Jury in Complex Litigation,” 20 Wm. & Mary L. Rev. 329 (1978); David L. Shapiro & Daniel R. Coquillette, “The Fetish of Jury Trial in Civil Cases: A Comment on Rachal v. Hill,” 85 Harvard L. Rev. 442 (1971); Comment, “English Judge May Not Order Jury Trial in Civil Case in Absence of Special Circumstances. Sims v. William Howard & Son Ltd. (C. A. 1964),” 78 Harv. L. Rev. 676 (1965); Fleming James, Jr., “Right to a Jury Trial in Civil Actions,” 72 Yale L. J. 655 (1963).

[4] In re Japanese Elec. Prods. Antitrust Litig., 63` F.2d 1069, 1079 (3d Cir 1980). See In re Boise Cascade Sec. Litig., 420 F. Supp. 99, 103 (W.D. Wash. 1976) (“In sum, it appears to this Court that the scope of the problems presented by this case is immense. The factual issues, the complexity of the evidence that will be required to explore those issues, and the time required to do so leads to the conclusion that a jury would not be a rational and capable fact finder.”). See also Ross v. Bernhard, 396 U.S. 532, 538 & n.10, 90 S. Ct. 733 (1970) (discussing the “legal” versus equitable nature of an action that might give rise to a right to trial by jury). Of course, the statistical and scientific complexity of claims was absent from cases tried in common law courts in 1791, at the time of the adoption of the seventh amendment.

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

[6] Corbett McDonald & Nicola Cherry, “Crystalline Silica and Lung Cancer: The Problem of Conflicting Evidence,” 8 Indoor Built Env’t 121, 121 (1999).

[7] Patrick A. Hessel, John F. Gamble, J. Bernard L. Gee, Graham Gibbs, Francis H.Y. Green, W. Keith C. Morgan, and Brooke T. Mossman, “Silica, Silicosis, and Lung Cancer: A Response to a Recent Working Group Report,” 42 J. Occup & Envt’l Med. 704, 704 (2000).

[8] Steven Nissen & K. Wolski, “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” 356 New Engl. J. Med. 2457 (2007); Erratum, 357 New Engl. J. Med. 100 (2007).

[9] In re Avandia Mktg., Sales Practices & Prods. Liab. Litig., 2011 WL 13576 (E.D. Pa. Jan. 4, 2011).

[10] Philip D. Home, Stuart J Pocock, et al., “Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD),” 373 Lancet 2125 (2009). The hazard ratios for cardiovascular death was 0.84 (95% C.I., 0·59–1·18), and for myocardial infarction, 1·14 (95% C.I., 0·80–1·63).

[11] Consenus Rule at 424 (emphasis added) (citing Ronald L. Wasserstein & Nicole A. Lazar, “The ASA Statement on p-Values: Context, Process, and Purpose,” 70 Am. Statistician 129, 131 (2016)).

[12] Yoav Benjamini, Richard D. DeVeaux, Bradly Efron, Scott Evans, Mark Glickman, Barry Braubard, Xuming He, Xiao Li Meng, Nancy Reid, Stephen M. Stigler, Stephen B. Vardeman, Christopher K. Wikle, Tommy Wright, Linda J. Young, and Karen Kafadar, “The ASA President’s Task Force Statement on Statistical Significance and Replicability,” 15 Annals of Applied Statistics 1084 (2021); see also “A Proclamation from the Task Force on Statistical Significance” (June 21, 2021).

[13] Sutera v. Perrier Group of America, Inc., 986 F. Supp. 655, 664-65 (D. Mass. 1997).

[14] Burst v. Shell Oil Co., 2015 WL 3755953, at *9 (E.D. La. June 16, 2015), aff’d, 650 F. App’x 170 (5th Cir. 2016). cert. denied. 137 S. Ct. 312 (2016); Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1156 (E.D. Wa. 2009).

[15] In re Mirena Ius Levonorgestrel-Related Prod. Liab. Litig. (No. II), 341 F. Supp. 3d 213 (S.D.N.Y. 2018), aff’d, 982 F.3d 113 (2d Cir. 2020); In re Lipitor (Atorvastatin Calcium) Mktg., Sales Pracs. & Prods. Liab. Litig., 227 F. Supp. 3d 452 (D.S.C. 2017), aff’d, 892 F.3d 624 (4th Cir. 2018); In re: Zoloft (Sertraline Hydrocloride) Prod. Liab. Litig., No. 12-MD-2342, 2015 WL 7776911, at *1 (E.D. Pa. Dec. 2, 2015), aff’d, 858 F.3d 787 (3d Cir. 2017); In re Incretin-Based Therapies Prods. Liab. Litig., 524 F. Supp. 3d. 1007 (S.D. Cal. 2021); In re Viagra (Sildenafil Citrate) & Cialis (Tadalafil) Prod. Liab. Litig., 424 F. Supp. 3d 781, 798–99 (N.D. Cal. 2020).

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

Cheng’s Proposed Consensus Rule for Expert Witnesses

September 15th, 2022

Edward K. Cheng is the Hess Professor of Law in absentia from Vanderbilt Law School, while serving this fall as a visiting professor at Harvard. Professor Cheng is one of the authors of the multi-volume treatise, Modern Scientific Evidence, and the author of many articles on scientific and statistical evidence. Cheng’s most recent article, “The Consensus Rule: A New Approach to Scientific Evidence,”[1] while thought provoking, follows in the long-standing tradition of law school professors to advocate evidence law reforms, based upon theoretical considerations devoid of practical or real-world support.

Cheng’s argument for a radical restructuring of Rule 702 is based upon his judgment that jurors and judges are epistemically incompetent to evaluate expert witness opinion testimony. The current legal approach has trial judges acting as gatekeepers of expert witness testimony, and jurors acting as judges of factual scientific claims. Cheng would abolish these roles as beyond their ken.[2] Lay persons can, however, determine which party’s position is supported by the relevant expert community, which he presumes (without evidence) possesses the needed epistemic competence. Accordingly, Cheng would rewrite the legal system’s approach to important legal disputes, such as disputes over causal claims, from:

Whether a given substance causes a given disease

to

Whether the expert community believes that a given substance causes a given disease.

Cheng channels the philosophical understanding of the ancients who realized that one must have expertise to judge whether someone else has used that expertise correctly. And he channels the contemporary understanding that knowledge is a social endeavor, not the unique perspective of an individual in isolation. From these twin premisses, Cheng derives a radical and cynical proposal to reform the law of expert witness testimony. In his vision, experts would come to court not to give their own opinions, and certainly not to try to explain how they arrive at their opinions from the available evidence. For him, the current procedure is too much like playing chess with a monkey. The expert function would consist of telling the jury what the expert witness’s community believes.[3] Jurors would not decide the “actual substantive questions,” but simply decide what they believe the relevant expert witness community accepts as a consensus. This radical restructuring is what Cheng calls the “consensus rule.”

In this proposed “consensus rule,” there is no room for gatekeeping. Parties continue to call expert witnesses, but only as conduits for the “consensus” opinions of their fields. Indeed, Cheng’s proposal would radically limit expert witness to service as pollsters; their testimony would present only their views of what the consensus is in their fields. This polling information is the only evidence that the jury hear from expert witnesses, because this is the only evidence that Cheng believes the jury is epistemically competent to assess.[4]

Under Cheng’s Consensus Rule, when there is no consensus in the realm, the expert witness regime defaults to “anything goes,” without gatekeeping.[5] Judges would continue to exercise some control over who is qualified to testify, but only as far as the proposed experts must be in a position to know what the consensus is in their fields.

Cheng does not explain why, under his proposed “consensus rule,” subject matter experts are needed at all.  The parties might call librarians, or sociologists of science, to talk about the relevant evidence of consensus. If a party cannot afford a librarian expert witness, then perhaps lawyers could present directly the results of their PubMed, and other internet searches.

Cheng may be right that his “deferential approach” would eliminate having the inexpert passing judgment on the expert. The “consensus rule” would reduce science to polling, conducted informally, often without documentation or recording, by partisan expert witnesses. This proposal hardly better reflects, as he argues, the “true” nature of science. In Cheng’s vision, science in the courtroom is just a communal opinion, without evidence and without inference. To be sure, this alternative universe is tidier and less disputatious, but it is hardly science or knowledge. We are left with opinions about opinions, without data, without internal or external validity, and without good and sufficient facts and data.

Cheng claims that his proposed Consensus Rule is epistemically superior to Rule 702 gatekeeping. For the intellectual curious and able, his proposal is a counsel of despair. Deference to the herd, he tells us “is not merely optimal—it is the only practical strategy.”[6] In perhaps the most extreme overstatement of his thesis, Cheng tells us that

“deference is arguably not due to any individual at all! Individual experts can be incompetent, biased, error prone, or fickle—their personal judgments are not and have never been the source of reliability. Rather, proper deference is to the community of experts, all of the people who have spent their careers and considerable talents accumulating knowledge in their field.”[7]

Cheng’s hypothesized community of experts, however is worthy of deference only by virtue of the soundness of its judgments. If a community has not severely tested its opinions, then its existence as a community is irrelevant. Cheng’s deference is the sort of phenomenon that helped create Lysenkoism and other intellectual fads that were beyond challenge with actual data.

There is, I fear, some partial truth to Cheng’s judgment of juries and judges as epistemically incompetent, or challenged, to judge science, but his judgment seems greatly overstated. Finding aberrant jury verdicts would be easy, but Cheng provides no meaningful examples of gatekeeping gone wrong. Professor Cheng may have over-generalized in stating that judges are epistemically incompetent to make substantive expert determinations. He surely cannot be suggesting that judges never have sufficient scientific acumen to determine the relevance and reliability of expert witness opinion. If judges can, in some cases, make a reasonable go at gatekeeping, why then is Cheng advocating a general rule that strips all judges of all gatekeeping responsibility with respect to expert witnesses?

Clearly judges lack the technical resources, time, and background training to delve deeply into the methodological issues with which they may be confronted. This situation could be ameliorated by budgeting science advisors and independent expert witnesses, and by creating specialty courts staffed with judges that have scientific training. Cheng acknowledges this response, but he suggests that conflicts with “norms about generalist judges.”[8] This retreat to norms is curious in the face of Cheng’s radical proposals, and the prevalence of using specialist judges for adjudicating commercial and patent disputes.

Although Cheng is correct that assessing validity and reliability of scientific inferences and conclusions often cannot be reduced to a cookbook or checklist approach, not all expertise is as opaque as Cheng suggests. In his view, lawyers are deluded into thinking that they can understand the relevant science, with law professors being even worse offenders.[9] Cross-examining a technical expert witness can be difficult and challenging, but lawyers on both sides of the aisle occasionally demolish the most skilled and knowledgeable expert witnesses, on substantive grounds. And these demolitions happen to expert witnesses who typically, self-servingly claim that they have robust consensuses agreeing with their opinions.

While scolding us that we must get “comfortable with relying on the expertise and authority of others,” Cheng reassures us that deferring to authority is “not laziness or an abdication of our intellectual responsibility.”[10] According to Cheng, the only reason to defer to the opinion of expert is that they are telling us what their community would say.[11] Good reasons, sound evidence, and valid inference need not worry us in Cheng’s world.

Finding Consensus

Cheng tells us that his Consensus Rule would look something like:

“Rule 702A. If the relevant scientific community believes a fact involving specialized knowledge, then that fact is established accordingly.”

Imagine the endless litigation over what the “relevant” community is. For a health effect claim about a drug and heart attacks, is it the community of cardiologists or epidemiologists? Do we accept the pronouncements of the American Heart Association or those of the American College of Cardiology. If there is a clear consensus based upon a clinical trial, which appears to be based upon suspect data, is discovery of underlying data beyond the reach of litigants because the correctness of the allegedly dispositive study is simply not in issue? Would courts have to take judicial notice of the clear consensus and shut down any attempt to get to the truth of the matter?

Cheng acknowledges that cases will involve issues that are controversial or undeveloped, without expert community consensus. Many litigations start after publication of a single study or meta-analysis, which is hardly the basis for any consensus. Cheng appears content, in this expansive area, to revert to anything goes because if the expert community has not coalesced around a unified view, or if the community is divided, then the courts cannot do better than flipping a coin! Cheng’s proposal thus has a loophole the size of the Sun.

Cheng tells us, unhelpfully, that “[d]etermining consensus is difficult in some cases, and less so in others.”[12] Determining consensus may not be straightforward, but no matter. Consensus Rule questions are not epistemically challenging and thus “far more manageable,” because they requires no special expertise. (Again, why even call a subject matter expert witness, as opposed to a science journalist or librarian?) Cheng further advises that consensus is “a bit like the reasonable person standard in negligence,” but this simply conflates normative judgments with the scientific judgments.[13]

Cheng’s Consensus Rule would allow the use of a systematic review or a meta-analysis, not for evidence of the correctness of its conclusions, but only as evidence of a consensus.[14] The thought experiment of how this suggestion plays out in the real world may cause some agita. The litigation over Avandia began within days of the publication of a meta-analysis in the New England Journal of Medicine.[15] So some evidence of consensus; right? But then the letters to the editor within a few weeks of publication showed that the meta-analysis was fatally flawed. Inadmissible! Under the Consensus Rule the correctness or the methodological appropriateness of the meta-analysis is irrelevant. A few months later, another meta-analysis is published, which fails to find the risk that the original meta-analysis claimed. Is the trial now about which meta-analysis represents the community’s consensus, or are we thrown into the game of anything goes, where expert witnesses just say things, without judicial supervision?  A few years go by, and now there is a large clinical trial that supersedes all the meta-analyses of small trials.[16] Is a single large clinical trial now admissible as evidence of a new consensus, or are only systematic reviews and meta-analyses relevant evidence?

Cheng’s Consensus Rule will be useless in most determinations of specific causation.  It will be a very rare case indeed when a scientific organization issues a consensus statement about plaintiff John Doe. Very few tort cases involve putative causal agents that are thought to cause every instance of some disease in every person exposed to the agent. Even when a scientific community has addressed general causation, it will have rarely resolved all the uncertainty about the causal efficacy of all levels of exposure or the appropriate window of latency. So Cheng’s proposal guarantees to remove specific causation from the control of Rule 702 gatekeeping.

The potential for misrepresenting consensus is even greater than the misrepresentations of actual study results. At least the data are the data, but what will jurors do when they are regaled by testimony about the informal consensus reached in the hotel lobby of the latest scientific conference. Regulatory pronouncements that are based upon precautionary principles will be misrepresented as scientific consensus.  Findings by the International Agency for Research on Cancer that a substance is a IIA “probable human carcinogen” will be hawked as a consensus, even though the classification specifically disclaims any quantitative meaning for “probable,” and it directly equates to “insufficient” evidence of carcinogencity in humans.

In some cases, as Cheng notes, organizations such as the National Research Council, or the National Academy of Science, Engineering and Medicine (NASEM), will have weighed in on a controversy that has found its way into court.[17] Any help from such organizations will likely be illusory. Consider the 2006 publication of a comprehensive review of the available studies on non-pulmonary cancers and asbestos exposure by NASEM. The writing group presented its assessment of colorectal cancer as not causally associated with occupational asbestos exposure.[18] By 2007, the following year, expert witnesses for plaintiffs argued that the NASEM publication was no longer a consensus because one or two (truly inconsequential studies) had been published after the report and thus not considered. Under Cheng’s proposal, this dodge would appear to be enough to oust the consensus rule, and default to the “anything goes” rule. The scientific record can change rapidly, and many true consensus statements quickly find their way into the dustbin of scientific history.

Cheng greatly underestimates the difficulty in ascertaining “consensus.” Sometimes, to be sure, professional societies issue consensus statements, but they are often tentative and inconclusive. In many areas of science, there will be overlapping realms of expertise, with different disciplines issuing inconsistent “consensus” statements. Even within a single expert community, there may be two schools of thoughts about a particular issue.

There are instances, perhaps more than a few, when a consensus is epistemically flawed. If, as is the case in many health effect claims, plaintiffs rely upon the so-called linear no-threshold dose-response (LNT) theory of carcinogenesis, plaintiffs will point to regulatory pronouncements that embrace LNT as “the consensus.” When scientists are being honest, they generally recognize LNT as part of a precautionary principle approach, which may make sense as the foundation of “risk assessment.” The widespread assumption of LNT in regulatory agencies, and among scientists who work in such agencies, is understandable, but LNT remains an assumption. Nonetheless, we already see LNT hawked as a consensus, which under Cheng’s Consenus Rule would become the key dispositive issue, while quashing the mountain of evidence that there are, in fact, defense mechanisms to carcinogenesis that result in practical thresholds.

Beyond, regulatory pronouncements, some areas of scientific endeavor have themselves become politicized and extremist. Tobacco smoking surely causes lung cancer, but the studies of environmental tobacco smoking and lung cancer have been oversold. In areas of non-scientific disputes, such as history of alleged corporate malfeasance, juries will be treated to “the consensus” of Marxist labor historians, without having to consider the actual underlying historical documents. Cheng tells us that his Consensus Rule is a “realistic way of treating nonscientific expertise,”[19] which would seem to cover historian expert witness. Yet here, lawyers and lay fact finders are fully capable of exploring the glib historical conclusions of historian witnesses with cross-examination on the underlying documentary facts of the proffered opinions.

The Alleged Warrant for the Consensus Rule

If Professor Cheng is correct that the current judicial system, with decisions by juries and judges, is epistemically incompetent, does his Consensus Rule necessarily follow?  Not really. If we are going to engage in radical reforms, then the institutionalization of blue-ribbon juries would make much greater sense. As for Cheng’s claim that knowledge is “social,” the law of evidence already permits the use of true consensus statements as learned treatises, both to impeach expert witnesses who disagree, and (in federal court) to urge the truth of the learned treatise.

The gatekeeping process of Rule 702, which Professor Cheng would throw overboard, has important advantages in that judges ideally will articulate reasons for finding expert witness opinion testimony admissible or not. These reasons can be evaluated, discussed, and debated, with judges, lawyers, and the public involved. This gatekeeping process is rational and socially open.

Some Other Missteps in Cheng’s Argument

Experts on Both Sides are Too Extreme

Cheng’s proposal is based, in part, upon his assessment that the adversarial system causes the parties to choose expert witnesses “at the extremes.” Here again, Cheng provides no empirical evidence for his assessment. There is a mechanical assumption often made by people who do not bother to learn the details of a scientific dispute that the truth must somehow lie in the “middle.” For instance, in MDL 926, the silicone gel breast implant litigation, presiding Judge Sam Pointer complained about the parties’ expert witnesses being too extreme. Judge Pointer  believed that MDL judges should not entertain Rule 702 challenges, which were in his view properly heard by the transferor courts. As a result, Judge Robert Jones, and then Judge Jack Weinstein, conducted thorough Rule 702 hearings and found that the plaintiffs’ expert witnesses’ opinions were unreliable and insufficiently supported by the available evidence.[20] Judge Weinstein started the process of selecting court-appointed expert witnesses for the remaining New York cases, which goaded Judge Pointer into taking the process back to the MDL court level. After appointing four, highly qualified expert witnesses, Judge Pointer continued to believe that the parties’ expert witnesses were “extremists,” and that the courts’ own experts would come down somewhere between them.  When the court-appointed experts filed their reports, Judge Pointer was shocked that all four of his experts sided with the defense in rejecting the tendentious claims of plaintiffs’ expert witnesses.

Statistical Significance

Along the way, in advocating his radical proposal, Professor Cheng made some other curious announcements. For instance, he tells us that “[w]hile historically used as a rule of thumb, statisticians have now concluded that using the 0.05 [p-value] threshold is more distortive than helpful.”[21] Cheng’s purpose here is unclear, but the source he cited does not remotely support his statement, and certainly not his gross overgeneralization about “statisticians.” If this is the way he envisions experts will report “consensus,” then his program seems broken at its inception. The American Statistical Association’s (ASA) p-value “consensus” statement articulated six principles, the third of which noted that

“[s]cientific conclusions and business or policy decisions should not be based only on whether a p-value passes a specific threshold.”

This is a few light years away from statisticians’ concluding that statistical significance thresholds are more distortive than helpful. The ASA p-value statement further explains that

“[t]he widespread use of ‘statistical significance’ (generally interpreted as ‘p < 0.05’) as a license for making a claim of a scientific finding (or implied truth) leads to considerable distortion of the scientific process.”[22]

In the science of health effects, statistical significance remains extremely important, but it has never been a license for making causal claims. As Sir Austin Bradford Hill noted in his famous after-dinner speech, ruling out chance (and bias) as an explanation for an association was merely a predicate for evaluating the association for causality.[23]

Over-endorsing Animal Studies

Under Professor Cheng’s Consensus Rule, the appropriate consensus might well be one generated solely by animal studies. Cheng tells that “perhaps” scientists do not consider toxicology when the pertinent epidemiology is “clear.” When the epidemiology, however, is unclear, scientists consider toxicology.[24] Well, of course, but the key question is whether a consensus about causation in humans will be based upon non-human animal studies. Cheng seems to answer this question in the affirmative by criticizing courts that have required epidemiologic studies “even though the entire field of toxicology uses tissue and animal studies to make inferences, often in combination with and especially in the absence of epidemiology.”[25] The vitality of the field of toxicology is hardly undermined by its not generally providing sufficient grounds for judgments of human causation.

Relative Risk Greater Than Two

In the midst of his argument for the Consensus Rule, Cheng points critically to what he calls “questionable proxies” for scientific certainty. One such proxy is the judicial requirement of risk ratios in excess of two. His short discussion appears to be focused upon the inference of specific causation in a given case, but it leads to a non-sequitur:

“Some courts have required a relative risk of 2.0 in toxic tort cases, requiring a doubling of the population risk before considering causation.73 But the preponderance standard does not require that the substance more likely than not caused any case of the disease in the population, it requires that the substance more likely than not caused the plaintiff’s case.”[26]

Of course, it is exactly because we are interested in the probability of causation of the plaintiff’s case, that we advert to the risk ratio to give us some sense whether “more likely than not” the exposure caused plaintiff’s case. Unless plaintiff can show he is somehow unique, he is “any case.” In many instances, plaintiff cannot show how he is different from the participants of the study that gave rise to the risk ratio less than two.

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

[2] Consensus Rule at 410 (“The judge and the jury, lacking in expertise, are not competent to handle the questions that the Daubert framework assigns to them.”)

[3] Consensus Rule at 467 (“Under the Consensus Rule, experts no longer offer their personal opinions on causation or teach the jury how to assess the underlying studies. Instead, their testimony focuses on what the expert community as a whole believes about causation.”)

[4] Consensus Rule at 467.

[5] Consensus Rule at 437.

[6] Consensus Rule at 434.

[7] Consensus Rule at 434.

[8] Consensus Rule at 422.

[9] Consensus Rule at 429.

[10] Consensus Rule at 432-33.

[11] Consensus Rule at 434.

[12] Consensus Rule at 456.

[13] Consensus Rule at 457.

[14] Consensus Rule at 459.

[15] Steven E. Nissen, M.D., and Kathy Wolski, M.P.H., “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” 356 New Engl. J. Med. 2457 (2007).

[16] P.D. Home, et al., “Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD), 373 Lancet 2125 (2009).

[17] Consensus Rule at 458.

[18] Jonathan M. Samet, et al., Asbestos: Selected Health Effects (2006).

[19] Consensus Rule at 445.

[20] Hall v. Baxter Healthcare Corp., 947 F. Supp.1387 (D. Or. 1996) (excluding plaintiffs’ expert witnesses’ causation opinions); In re Breast Implant Cases, 942 F. Supp. 958 (E. & S.D.N.Y. 1996) (granting partial summary judgment on claims of systemic disease causation).

[21] Consenus Rule at 424 (citing Ronald L. Wasserstein & Nicole A. Lazar, “The ASA Statement on p-Values: Context, Process, and Purpose,” 70 Am. Statistician 129, 131 (2016)).

[22] Id.

[23] Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965). See Schachtman, “Ruling Out Bias & Confounding is Necessary to Evaluate Expert Witness Causation Opinions” (Oct. 29, 2018); “Woodside & Davis on the Bradford Hill Considerations” (Aug. 23, 2013); Frank C. Woodside, III & Allison G. Davis, “The Bradford Hill Criteria: The Forgotten Predicate,” 35 Thomas Jefferson L. Rev. 103 (2013).

[24] Consensus Rule at 444.

[25] Consensus Rule at 424 & n. 74 (citing to one of multiple court advisory expert witnesses in Hall v. Baxter Healthcare Corp., 947 F. Supp.1387, 1449 (D. Or. 1996), who suggested that toxicology would be appropriate to consider when the epidemiology was not clear). Citing to one outlier advisor is a rather strange move for Cheng considering that the “consensus” was readily discernible to the trial judge in Hall, and to Judge Jack Weinstein, a few months later, in In re Breast Implant Cases, 942 F. Supp. 958 (E. & S.D.N.Y. 1996).

[26] Consensus Rule at 424 & n. 73 (citing Lucinda M. Finley, “Guarding the Gate to the Courthouse: How Trial Judges Are Using Their Evidentiary Screening Role to Remake Tort Causation Rules,” 49 Depaul L. Rev. 335, 348–49 (2000). See Schachtman, “Rhetorical Strategy in Characterizing Scientific Burdens of Proof” (Nov. 15, 2014).

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