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The Rise of Agnothology as Conspiracy Theory

July 19th, 2022

A few egregious articles in the biomedical literature have begun to endorse explicitly asymmetrical standards for inferring causation in the context of environmental or occupational exposures. Very little if anything is needed for inferring causation, and nothing counts against causation.  If authors refuse to infer causation, then they are agents of “industry,” epidemiologic malfeasors, and doubt mongers.

For an example of this genre, take the recent article, entitled “Toolkit for detecting misused epidemiological methods.”[1] [Toolkit] Please.

The asymmetry begins with Trump-like projection of the authors’ own foibles. The principal hammer in the authors’ toolkit for detecting misused epidemiologic methods is personal, financial bias. And yet, somehow, in an article that calls out other scientists for having received money from “industry,” the authors overlooked the business of disclosing their receipt of monies from one of the biggest industries around – the lawsuit industry.

Under the heading “competing interests,” the authors state that “they have no competing interests.”[2]  Lead author, Colin L. Soskolne, was, however, an active, partisan expert witness for plaintiffs’ counsel in diacetyl litigation.[3] In an asbestos case before the Pennsylvania Supreme Court, Rost v. Ford Motor Co., Soskolne signed on to an amicus brief, supporting the plaintiff, using his science credentials, without disclosing his expert witness work for plaintiffs, or his long-standing anti-asbestos advocacy.[4]

Author Shira Kramer signed on to Toolkit, without disclosing any conflicts, but with an even more impressive résumé of pro-plaintiff litigation experience.[5] Kramer is the owner of Epidemiology International, in Cockeysville, Maryland, where she services the lawsuit industry. She too was an “amicus” in Rost, without disclosing her extensive plaintiff-side litigation consulting and testifying.

Carl Cranor, another author of Toolkit, takes first place for hypocrisy on conflicts of interest. As a founder of Council for Education and Research on Toxics (CERT), he has sterling credentials for monetizing the bounty hunt against “carcinogens,” most recently against coffee.[6] He has testified in denture cream and benzene litigation, for plaintiffs. When he was excluded under Rule 702 from the Milward case, CERT filed an amicus brief on his behalf, without disclosing that Cranor was a founder of that organization.[7], [8]

The title seems reasonably fair-minded but the virulent bias of the authors is soon revealed. The Toolkit is presented as a Table in the middle of the article, but the actual “tools” are for the most part not seriously discussed, other than advice to “follow the money” to identify financial conflicts of interest.

The authors acknowledge that epidemiology provides critical knowledge of risk factors and causation of disease, but they quickly transition to an effort to silence any industry commentator on any specific epidemiologic issue. As we will see, the lawsuit industry is given a complete pass. Not surprisingly, several of the authors (Kramer, Cranor, Soskolne) have worked closely in tandem with the lawsuit industry, and have derived financial rewards for their efforts.

Repeatedly, the authors tell us that epidemiologic methods and language are misused by “powerful interests,” which have financial stakes in the outcome of research. Agents of these interests foment uncertainty and doubt about causal relationships through “disinformation,” “malfeasance,” and “doubt mongering.” There is no correlative concern about false claiming or claim mongering..

Who are these agents who plot to sabotage “social justice” and “truth”? Clearly, they are scientists with whom the Toolkit authors disagree. The Toolkit gang cites several papers as exemplifying “malfeasance,”[9] but they never explain what was wrong with them, or how the malfeasors went astray.  The Toolkit tactics seem worthy of Twitter smear and run.

The Toolkit

The authors’ chart of “tools” used by industry might have been an interesting taxonomy of error, but mostly they are ad hominem attack on scientists with whom they disagree. Channeling Putin on Ukraine, those scientists who would impose discipline and rigor on epidemiologic science are derided as not “real epidemiologists,” and, to boot, they are guilty of ethical lapses in failing to advance “social justice.”

Mostly the authors give us a toolkit for silencing those who would get in the way of the situational science deployed at the beck and call of the lawsuit industry.[10] Indeed, the Toolkit authors are not shy about identifying their litigation goals; they tell us that the toolkit can be deployed in depositions and in cross-examinations to pursue “social justice.” These authors also outline a social agenda that greatly resembles the goals of cancel culture: expose the perpetrators who stand in the way of the authors’preferred policy choices, diminish their adversaries’ their influence on journals, and galvanize peer reviewers to reject their adversaries’ scientific publications. The Toolkit authors tell us that “[t] he scientific community should engage by recognizing and professionally calling out common practices used to distort and misapply epidemiological and other health-related sciences.”[11] What this advice translates into are covert and open ad hominem campaigns as peer reviewers to block publications, to deny adversaries tenure and promotions, and to use social and other media outlets to attack adversaries’ motives, good faith, and competence.

None of this is really new. Twenty-five years ago, the late F. Douglas K. Liddell railed at the Mt. Sinai mob, and the phenomenon was hardly new then.[12] The Toolkit’s call to arms is, however, quite open, and raises the question whether its authors and adherents can be fair journal editors and peer reviewers of journal submissions.

Much of the Toolkit is the implementation of a strategy developed by lawsuit industry expert witnesses to demonize their adversaries by accusing them of manufacturing doubt or ignorance or uncertainty. This strategy has gained a label used to deride those who disagree with litigation overclaiming: agnotology or the creation of ignorance. According to Professor Robert Proctor, a regular testifying historian for tobacco plaintiffs, a linguist, Iain Boal, coined the term agnotology, in 1992, to describe the study of the production of ignorance.[13]

The Rise of “Agnotology” in Ngram

Agnotology has become a cottage sub-industry of the lawsuit industry, although lawsuits (or claim mongering if you like), of course, remain their main product. Naomi Oreskes[14] and David Michaels[15] gave the agnotology field greater visibility with their publications, using the less erudite but catchier phrase “manufacturing doubt.” Although the study of ignorance and uncertainty has a legitimate role in epistemology[16] and sociology,[17] much of the current literature is dominated by those who use agnotology as propaganda in support of their own litigation and regulatory agendas.[18] One lone author, however, appears to have taken agnotology study seriously enough to see that it is largely a conspiracy theory that reduces complex historical or scientific theory, evidence, opinion, and conclusions to a clash between truth and a demonic ideology.[19]

Is there any substance to the Toolkit?

The Toolkit is not entirely empty of substantive issues. The authors note that “statistical methods are a critical component of the epidemiologist’s toolkit,”[20] and they cite some articles about common statistical mistakes missed by peer reviewers. Curiously, the Toolkit omits any meaningful discussion of statistical mistakes that increase the risk of false positive results, such as multiple comparisons or dichotomizing continuous confounder variables. As for the Toolkit’s number one identified “inappropriate” technique used by its authors’ adversaries, we have:

“A1. Relying on statistical hypothesis testing; Using ‘statistical significance’ at the 0.05 level of probability as a strict decision criterion to determine the interpretation of statistical results and drawing conclusions.”

Peer into the hearings of any federal court so-called Daubert motion, and you will see the lawsuit industry, and its hired expert witnesses, rail at statistical significance, unless of course, there is some subgroup that has nominal significance, in which case, they are all in for endorsing the finding as “conclusive.” 

Welcome to asymmetric, situational science.

[1] Colin L. Soskolne, Shira Kramer, Juan Pablo Ramos-Bonilla, Daniele Mandrioli, Jennifer Sass, Michael Gochfeld, Carl F. Cranor, Shailesh Advani & Lisa A. Bero, “Toolkit for detecting misused epidemiological methods,” 20(90) Envt’l Health (2021) [Toolkit].

[2] Toolkit at 12.

[3] Watson v. Dillon Co., 797 F.Supp. 2d 1138 (D. Colo. 2011).

[4] Rost v. Ford Motor Co., 151 A.3d 1032 (Pa. 2016). See “The Amicus Curious Brief” (Jan. 4, 2018).

[5] See, e.g., Sean v. BMW of North Am., LLC, 26 N.Y.3d 801, 48 N.E.3d 937, 28 N.Y.S.3d 656 (2016) (affirming exclusion of Kramer); The Little Hocking Water Ass’n v. E.I. Du Pont De Nemours & Co., 90 F.Supp.3d 746 (S.D. Ohio 2015) (excluding Kramer); Luther v. John W. Stone Oil Distributor, LLC, No. 14-30891 (5th Cir. April 30, 2015) (mentioning Kramer as litigation consultant); Clair v. Monsanto Co., 412 S.W.3d 295 (Mo. Ct. App. 2013 (mentioning Kramer as plaintiffs’ expert witness); In re Chantix (Varenicline) Prods. Liab. Litig., No. 2:09-CV-2039-IPJ, MDL No. 2092, 2012 WL 3871562 (N.D.Ala. 2012) (excluding Kramer’s opinions in part); Frischhertz v. SmithKline Beecham Corp., 2012 U.S. Dist. LEXIS 181507, Civ. No. 10-2125 (E.D. La. Dec. 21, 2012) (excluding Kramer); Donaldson v. Central Illinois Public Service Co., 199 Ill. 2d 63, 767 N.E.2d 314 (2002) (affirming admissibility of Kramer’s opinions in absence of Rule 702 standards).

[6]  “The Council for Education & Research on Toxics” (July 9, 2013) (CERT amicus brief filed without any disclosure of conflict of interest). Among the fellow travelers who wittingly or unwittingly supported CERT’s scheme to pervert the course of justice were lawsuit industry stalwarts, Arthur L. Frank, Peter F. Infante, Philip J. Landrigan, Barry S. Levy, Ronald L. Melnick, David Ozonoff, and David Rosner. See also NAS, “Carl Cranor’s Conflicted Jeremiad Against Daubert” (Sept. 23, 2018); Carl Cranor, “Milward v. Acuity Specialty Products: How the First Circuit Opened Courthouse Doors for Wronged Parties to Present Wider Range of Scientific Evidence” (July 25, 2011).

[7] Milward v. Acuity Specialty Products Group, Inc., 664 F. Supp. 2d 137, 148 (D. Mass. 2009), rev’d, 639 F.3d 11 (1st Cir. 2011), cert. den. sub nom. U.S. Steel Corp. v. Milward, 565 U.S. 1111 (2012), on remand, Milward v. Acuity Specialty Products Group, Inc., 969 F.Supp. 2d 101 (D. Mass. 2013) (excluding specific causation opinions as invalid; granting summary judgment), aff’d, 820 F.3d 469 (1st Cir. 2016).

[8] To put this effort into a sociology of science perspective, the Toolkit article is published in a journal, Environmental Health, an Editor in Chief of which is David Ozonoff, a long-time pro-plaintiff partisan in the asbestos litigation. The journal has an “ombudsman,”Anthony Robbins, who was one of the movers-and-shakers in forming SKAPP, The Project on Scientific Knowledge and Public Policy, a group that plotted to undermine the application of federal evidence law of expert witness opinion testimony. SKAPP itself now defunct, but its spirit of subverting law lives on with efforts such as the Toolkit. “More Antic Proposals for Expert Witness Testimony – Including My Own Antic Proposals” (Dec. 30, 2014). Robbins is also affiliated with an effort, led by historian and plaintiffs’ expert witness David Rosner, to perpetuate misleading historical narratives of environmental and occupational health. “ToxicHistorians Sponsor ToxicDocs” (Feb. 1, 2018); “Creators of ToxicDocs Show Off Their Biases” (June 7, 2019); Anthony Robbins & Phyllis Freeman, “ToxicDocs (www.ToxicDocs.org) goes live: A giant step toward leveling the playing field for efforts to combat toxic exposures,” 39 J. Public Health Pol’y 1 (2018).

[9] The exemplars cited were Paolo Boffetta, MD, MPH; Hans Olov Adami, Philip Cole, Dimitrios Trichopoulos, Jack Mandel, “Epidemiologic studies of styrene and cancer: a review of the literature,” 51 J. Occup. & Envt’l Med. 1275 (2009); Carlo LaVecchia & Paolo Boffetta, “Role of stopping exposure and recent exposure to asbestos in the risk of mesothelioma,” 21 Eur. J. Cancer Prev. 227 (2012); John Acquavella, David Garabrant, Gary Marsh G, Thomas Sorahan and Douglas L. Weed, “Glyphosate epidemiology expert panel review: a weight of evidence systematic review of the relationship between glyphosate exposure and non-Hodgkin’s lymphoma or multiple myeloma,” 46 Crit. Rev. Toxicol. S28 (2016); Catalina Ciocan, Nicolò Franco, Enrico Pira, Ihab Mansour, Alessandro Godono, and Paolo Boffetta, “Methodological issues in descriptive environmental epidemiology. The example of study Sentieri,” 112 La Medicina del Lavoro 15 (2021).

[10] The Toolkit authors acknowledge that their identification of “tools” was drawn from previous publications of the same ilk, in the same journal. Rebecca F. Goldberg & Laura N. Vandenberg, “The science of spin: targeted strategies to manufacture doubt with detrimental effects on environmental and public health,” 20:33 Envt’l Health (2021).

[11] Toolkit at 11.

[12] F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997). See “The Lobby – Cut on the Bias” (July 6, 2020).

[13] Robert N. Proctor & Londa Schiebinger, Agnotology: The Making and Unmaking of Ignorance (2008).

[14] Naomi Oreskes & Erik M. Conway, Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming (2010); Naomi Oreskes & Erik M. Conway, “Defeating the merchants of doubt,” 465 Nature 686 (2010).

[15] David Michaels, The Triumph of Doubt: Dark Money and the Science of Deception (2020); David Michaels, Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health (2008); David Michaels, “Science for Sale,” Boston Rev. 2020; David Michaels, “Corporate Campaigns Manufacture Scientific Doubt,” 174 Science News 32 (2008); David Michaels, “Manufactured Uncertainty: Protecting Public Health in the Age of Contested Science and Product Defense,” 1076 Ann. N.Y. Acad. Sci. 149 (2006); David Michaels, “Scientific Evidence and Public Policy,” 95 Am. J. Public Health s1 (2005); David Michaels & Celeste Monforton, “Manufacturing Uncertainty: Contested Science and the Protection of the Public’s Health and Environment,” 95 Am. J. Pub. Health S39 (2005); David Michaels & Celeste Monforton, “Scientific Evidence in the Regulatory System: Manufacturing Uncertainty and the Demise of the Formal Regulatory Ssytem,” 13 J. L. & Policy 17 (2005); David Michaels, “Doubt is Their Product,” Sci. Am. 96 (June 2005); David Michaels, “The Art of ‘Manufacturing Uncertainty’,” L.A. Times (June 24, 2005).

[16] See, e.g., Sibilla Cantarini, Werner Abraham, and Elisabeth Leiss, eds., Certainty-uncertainty – and the Attitudinal Space in Between (2014); Roger M. Cooke, Experts in Uncertainty: Opinion and Subjective Probability in Science (1991).

[17] See, e.g., Ralph Hertwig & Christoph Engel, eds., Deliberate Ignorance: Choosing Not to Know (2021); Linsey McGoey, The Unknowers: How Strategic Ignorance Rules the World (2019); Michael Smithson, “Toward a Social Theory of Ignorance,” 15 J. Theory Social Behavior 151 (1985).

[18] See Janet Kourany & Martin Carrier, eds., Science and the Production of Ignorance: When the Quest for Knowledge Is Thwarted (2020); John Launer, “The production of ignorance,” 96 Postgraduate Med. J. 179 (2020); David S. Egilman, “The Production of Corporate Research to Manufacture Doubt About the Health Hazards of Products: An Overview of the Exponent BakeliteVR Simulation Study,” 28 New Solutions 179 (2018); Larry Dossey, “Agnotology: on the varieties of ignorance, criminal negligence, and crimes against humanity,” 10 Explore 331 (2014); Gerald Markowitz & David Rosner, Deceit and Denial: The Deadly Politics of Industrial Revolution (2002).

[19] See Enea Bianchi, “Agnotology: a Conspiracy Theory of Ignorance?” Ágalma: Rivista di studi culturali e di estetica 41 (2021).

[20] Toolkit at 4.

Posted in Causation, Cognitive Biases, Conflicts of Interest, Public Nuisances, Scientific Evidence, Scientific Misconduct, Scientific Publishing, statistical evidence | 1 Comment »

Madigan’s Shenanigans & Wells Quelled in Incretin-Mimetic Cases

July 15th, 2022

The incretin-mimetic litigation involved claims that the use of Byetta, Januvia, Janumet, and Victoza medications causes pancreatic cancer. All four medications treat diabetes mellitus through incretin hormones, which stimulate or support insulin production, which in turn lowers blood sugar. On Planet Earth, the only scientists who contend that these medications cause pancreatic cancer are those hired by the lawsuit industry.

The cases against the manufacturers of the incretin-mimetic medications were consolidated for pre-trial proceedings in federal court, pursuant to the multi-district litigation (MDL) statute, 28 US Code § 1407. After years of MDL proceedings, the trial court dismissed the cases as barred by the doctrine of federal preemption, and for good measure, excluded plaintiffs’ medical causation expert witnesses from testifying.[1] If there were any doubt about the false claiming in this MDL, the district court’s dismissals were affirmed by the Ninth Circuit.[2]

The district court’s application of Federal Rule of Evidence 702 to the plaintiffs’ expert witnesses’ opinion is an important essay in patho-epistemology. The challenged expert witnesses provided many examples of invalid study design and interpretation. Of particular interest, two of the plaintiffs’ high-volume statistician testifiers, David Madigan and Martin Wells, proffered their own meta-analyses of clinical trial safety data. Although the current edition of the Reference Manual on Scientific Evidence[3] provides virtually no guidance to judges for assessing the validity of meta-analyses, judges and counsel do now have other readily available sources, such as the FDA’s Guidance on meta-analysis of safety outcomes of clinical trials.[4] Luckily for the Incretin-Mimetics pancreatic cancer MDL judge, the misuse of meta-analysis methodology by plaintiffs’ statistician expert witnesses, David Madigan and Martin Wells was intuitively obvious.

Madigan and Wells had a large set of clinical trials at their disposal, with adverse safety outcomes assiduously collected. As is the case with many clinical trial safety outcomes, the trialists will often have a procedure for blinded or unblinded adjudication of safety events, such as pancreatic cancer diagnosis.

At deposition, Madigan testified that he counted only adjudicated cases of pancreatic cancer in his meta-analyses, which seems reasonable enough. As discovery revealed, however, Madigan employed the restrictive inclusion criteria of adjudicated pancreatic cancer only to the placebo group, not to the experimental group. His use of restrictive inclusion criteria for only the placebo group had the effect of excluding several non-adjudicated events, with the obvious spurious inflation of risk ratios. The MDL court thus found with relative ease that Madigan’s “unequal application of criteria among the two groups inevitably skews the data and critically undermines the reliability of his analysis.” The unexplained, unjustified change in methodology revealed Madigan’s unreliable “cherry-picking” and lack of scientific rigor as producing a result-driven meta-analyses.[5]

The MDL court similarly found that Wells’ reports “were marred by a selective review of data and inconsistent application of inclusion criteria.”[6] Like Madigan, Wells cherry picked studies. For instance, he excluded one study, EXSCEL, on grounds that it reported “a high pancreatic cancer event rate in the comparison group as compared to background rate in the general population….”[7] Wells’ explanation blatantly failed, however, given that the entire patient population of the clinical trial had diabetes, a known risk factor for pancreatic cancer.[8]

As Professor Ioannidis and others have noted, we are awash in misleading meta-analyses:

“Currently, there is massive production of unnecessary, misleading, and conflicted systematic reviews and meta-analyses. Instead of promoting evidence-based medicine and health care, these instruments often serve mostly as easily produced publishable units or marketing tools.  Suboptimal systematic reviews and meta-analyses can be harmful given the major prestige and influence these types of studies have acquired.  The publication of systematic reviews and meta-analyses should be realigned to remove biases and vested interests and to integrate them better with the primary production of evidence.”[9]

Whether created for litigation, like the Madigan-Wells meta-analyses, or published in the “peer-reviewed” literature, courts will have to up their game in assessing the validity of such studies. Published meta-analyses have grown exponentially from the 1990s to the present. To date, 248,886 meta-analyses have been published, according the National Library of Medicine’s Pub-Med database. Last year saw over 35,000 meta-analyses published. So far, this year, 20,416 meta-analyses have been published, and we appear to be on track to have a bumper crop.

The data analytics from Pub-Med provide a helpful visual representation of the growth of meta-analyses in biomedical science.

 

Count of Publications with Keyword Meta-analysis in Pub-Med Database

In 1979, the year I started law school, one meta-analysis was published. Lawyers could still legitimately argue that meta-analyses involved novel methodology that had not been generally accepted. The novelty of meta-analysis wore off sometime between 1988, when Judge Robert Kelly excluded William Nicholson’s meta-analysis of health outcomes among PCB-exposed workers, on grounds that such analyses were “novel,” and 1990, when the Third Circuit reversed Judge Kelly, with instructions to assess study validity.[10] Fortunately, or not, depending upon your point of view, plaintiffs dropped Nicholson’s meta-analysis in subsequent proceedings. A close look at Nicholson’s non-peer reviewed calculations shows that he failed to standardize for age or sex, and that he merely added observed and expected cases, across studies, without weighting by individual study variance. The trial court never had the opportunity to assess the validity vel non of Nicholson’s ersatz meta-analysis.[11] Today, trial courts must pick up on the challenge of assessing study validity of meta-analyses relied upon by expert witnesses, regulatory agencies, and systematic reviews.

[1] In re Incretin-Based Therapies Prods. Liab. Litig., 524 F.Supp.3d 1007 (S.D. Cal. 2021).

[2] In re Incretin-Based Therapies Prods. Liab. Litig., No. 21-55342, 2022 WL 898595 (9th Cir. Mar. 28, 2022) (per curiam)

[3]  “The Treatment of Meta-Analysis in the Third Edition of the Reference Manual on Scientific Evidence” (Nov. 15, 2011).

[4] Food and Drug Administration, Center for Drug Evaluation and Research, “Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products – (Draft) Guidance for Industry” (Nov. 2018); Jonathan J. Deeks, Julian P.T. Higgins, Douglas G. Altman, “Analysing data and undertaking meta-analyses,” Chapter 10, in Julian P.T. Higgins, James Thomas, Jacqueline Chandler, Miranda Cumpston, Tianjing Li, Matthew J. Page, and Vivian Welch, eds., Cochrane Handbook for Systematic Reviews of Interventions (version 6.3 updated February 2022); Donna F. Stroup, Jesse A. Berlin, Sally C. Morton, Ingram Olkin, G. David Williamson, Drummond Rennie, David Moher, Betsy J. Becker, Theresa Ann Sipe, Stephen B. Thacker, “Meta-Analysis of Observational Studies: A Proposal for Reporting,” 283 J. Am. Med. Ass’n 2008 (2000); David Moher, Alessandro Liberati, Jennifer Tetzlaff, and Douglas G Altman, “Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement,” 6 PLoS Med e1000097 (2009).

[5] In re Incretin-Based Therapies Prods. Liab. Litig., 524 F.Supp.3d 1007, 1037 (S.D. Cal. 2021). See In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prods. Liab. Litig. (No. II) MDL2502, 892 F.3d 624, 634 (4th Cir. 2018) (“Result-driven analysis, or cherry-picking, undermines principles of the scientific method and is a quintessential example of applying methodologies (valid or otherwise) in an unreliable fashion.”).

[6] In re Incretin-Based Therapies Prods. Liab. Litig., 524 F.Supp.3d 1007, 1043 (S.D. Cal. 2021).

[7] Id. at 1038.

[8] See, e.g., Albert B. Lowenfels & Patrick Maisonneuve, “Risk factors for pancreatic cancer,” 95 J. Cellular Biochem. 649 (2005).

[9] John P. Ioannidis, “The mass production of redundant, misleading, and conflicted systematic reviews and meta-analyses,” 94 Milbank Quarterly 485 (2016).

[10] In re Paoli R.R. Yard PCB Litig., 706 F. Supp. 358, 373 (E.D. Pa. 1988), rev’d and remanded, 916 F.2d 829, 856-57 (3d Cir. 1990), cert. denied, 499 U.S. 961 (1991). See also Hines v. Consol. Rail Corp., 926 F.2d 262, 273 (3d Cir. 1991).

[11] “The Shmeta-Analysis in Paoli” (July 11, 2019). See  James A. Hanley, Gilles Thériault, Ralf Reintjes and Annette de Boer, “Simpson’s Paradox in Meta-Analysis,” 11 Epidemiology 613 (2000); H. James Norton & George Divine, “Simpson’s paradox and how to avoid it,” Significance 40 (Aug. 2015); George Udny Yule, “Notes on the theory of association of attributes in statistics,” 2 Biometrika 121 (1903).

Posted in Causation, Expert Witness Hall of Shame, Meta-analysis, Rule 702, Scientific Evidence, Scientific Misconduct, statistical evidence | 1 Comment »

The Faux Bayesian Approach in Litigation

July 13th, 2022

In an interesting series of cases, an expert witness claimed to have arrived at the specific causation of plaintiff’s stomach cancer by using “Bayesian probabilities which consider the interdependence of individual probabilities.” Courtesy of counsel in the cases, I have been able to obtain a copy of the report of the expert witness, Dr. Robert P. Gale. The cases in which Dr. Gale served were all FELA cancer cases against the Union Pacific Railroad, brought for cancers diagnosed in the plaintiffs. Given his research and writings in hematopoietic cancers and molecular biology, Dr. Gale would seem to have been a credible expert witness for the plaintiffs in their cases.[1]

The three cases involving Dr. Gale were all decisions on Rule 702 motions to exclude his causation opinions. In all three cases, the court found Dr. Gale to be qualified to opine on causation, which finding is decided by a very low standard in federal court. In two of the cases, the same judge, federal Magistrate Judge Cheryl R. Zwart, excluded Dr. Gale’s opinions.[2] In at least one of the two cases, the decision seemed rather straightforward, given that Dr. Gale claimed to have ruled out alternative causes of Mr. Hernandez’s stomach cancer.  Somehow, despite his qualifications, however, Dr. Gale missed that Mr. Hernandez had had helicobacter pylori infections before he was diagnosed with stomach cancer.

In the third case, the district judge denied the Rule 702 motion against Dr. Gale, in a cursory, non-searching review.[3]

The common thread in all three cases is that the courts dutifully noted that Dr. Gale had described his approach to specific causation as involving “Bayesian probabilities which consider the interdependence of individual probabilities.” The judicial decisions never described how Dr. Gale’s invocation of Bayesian probabilities contributed to his specific causation opinion, and a careful review of Dr. Gale’s report reveals no such analysis. To be explicit, there was no discussion of prior or posterior probabilities or odds, no discussion of likelihood ratios, or Bayes factors. There was absolutely nothing in Dr. Gale’s report that would warrant his claim that he had done a Bayesian analysis of specific causation or of the “interdependence of individual probabilities” of putative specific causes.

We might forgive the credulity of the judicial officers in these cases, but why would Dr. Gale state that he had done a Bayesian analysis? The only reason that suggests itself is that Dr. Gale was bloviating in order to give his specific causation opinions an aura of scientific and mathematical respectability. Falsus in duo, falsus in omnibus.[4]

[1] See, e.g., Robert Peter Gale, et al., Fetal Liver Transplantation (1987); Robert Peter Gale & Thomas Hauser, Chernobyl: The Final Warning (1988); Kenneth A. Foon, Robert Peter Gale, et al., Immunologic Approaches to the Classification and Management of Lymphomas and Leukemias (1988); Eric Lax & Robert Peter Gale, Radiation: What It Is, What You Need to Know (2013).

[2] Byrd v. Union Pacific RR, 453 F.Supp.3d 1260 (D. Neb. 2020) (Zwart, M.J.); Hernandez v. Union Pacific RR, No. 8: 18CV62 (D. Neb. Aug. 14, 2020).

[3] Langrell v. Union Pacific RR, No. 8:18CV57, 2020 WL 3037271 (D. Neb. June 5, 2020) (Bataillon, S.J.).

[4] Dr. Gale’s testimony has not fared well elsewhere. See, e.g., In re Incretin-Based Therapies Prods. Liab. Litig., 524 F.Supp.3d 1007 (S.D. Cal. 2021) (excluding Gale); Wilcox v. Homestake Mining Co., 619 F. 3d 1165 (10th Cir. 2010); June v. Union Carbide Corp., 577 F. 3d 1234 (10th Cir. 2009) (affirming exclusion of Dr. Gale and entry of summary judgment); Finestone v. Florida Power & Light Co., 272 F. App’x 761 (11th Cir. 2008); In re Rezulin Prods. Liab. Litig., 309 F.Supp.2d 531 (S.D.N.Y. 2004) (excluding Dr. Gale from offering ethical opinions).

Posted in Causation, Rule 702, statistical evidence | No Comments »