Schachtman Law

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

Conflict of Interest Regulations Apply Symmetrically

July 25th, 2014

Last week, a federal judge ruled that working as a plaintiffs’ expert witness in tobacco litigation or as consultants for pharmaceutical companies with tobacco-cessation medications was a conflict of interest, which invalidated a FDA report on menthol cigarettes. Lorillard Inc. et al. v. U.S. Food and Drug Administration, 1:11-cv-00440, D.D.C. (July 21, 2014).

The report was issued in 2011 by the agency’s Tobacco Products Scientific Advisory Committee (TPSAC). Two tobacco companies sought an injunction against the FDA’s report because of the improper memberships on the TPSAC of Drs. Jonathan Samet and Neil Benowitz. Lorillard’s General Counsel also challenged agency pronouncements under the Data Quality Act. Letter Request for Correction of Information Disseminated to the Public and the Tobacco Products Scientific Advisory Committee (March 16, 2011) (petition lodged under the Data Quality Act (DQA), 44 U.S.C. § 3516, and the related agency regulations of the Office of Management and Budget, Health and Human Services, and FDA).

Although the TPSAC report concluded that menthol cigarettes imparted no greater risk of lung cancer than the already deadly non-menthol cigarettes, the report claimed that studies show menthol flavoring increased usage among young people and African Americans. The TPSAC recommended a ban on menthol cigarettes in the interest of public health. The district court held that the FDA’s decision that the disputed members had no conflict of interest violated the Administrative Procedures Act, and that the violation required the agency to reconstitute the TPSAC in compliance with the applicable ethics regulations.

What is remarkable about the case is its rejection of the delusion that advocacy for plaintiffs is not a potential conflict of interest, whereas advocacy for a company is. An amicus brief filed on behalf of several medical and public health groups, including Public Citizen, Inc., American Cancer Society, American Medical Association, American Thoracic Society, and others, supported the agency’s motion to dismiss. Amici argued that balancing scientific opinions of experts on the committee would impair the integrity of advisory committees and would be unmanageable for courts. Given the obvious adversarial bias from service as an expert witness in tobacco litigation, the district court rejected amici’s arguments. Although amici’s position is understandable as a reaction to the callousness of tobacco marketing, the brief’s indifference to the ethical implications about conflicts of interest is surprising. One can only imagine the hue and cry if there had been committee members who had been engaged as expert witnesses for the tobacco companies.

The implications of the Lorillard decision are considerable, especially for FDA advisory committees. See Glenn Lammi, “FDA Advisory Committee Not Rife with Conflicts of Interest? — ‛Please!’ Quips Federal Judge” (July 24, 2014) (discussing Lorillard case and detailing efforts to obtain FDA compliance with the Federal Advisory Committee Act). Industry representatives are typically non-voting members, but members who have been retained by the litigation industry have served in voting positions. In other contexts, expert witnesses for plaintiffs accuse scientists who testify for a defendant of “conflicts of interest,” but conveniently ignore and fail to disclose their own. See “More Hypocrisy Over Conflicts of Interest” (Dec. 4, 2010) (Arthur Frank, Richard Lemen, and Barry Castleman); James Coyne, “Lessons in Conflict of Interest: The Construction of the Martyrdom of David Healy and The Dilemma of Bioethics,” 5 Am. J. Bioethics W3 (2005). The Lorillard case teaches that “white hat” bias is as disqualifying as “black hat” bias.

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Subgroups — Subpar Statistical Practice versus Fraud

July 24th, 2014

Several people have asked me why I do not enable comments on this blog. Although some bloggers (e.g., Deborah Mayo’s Error Statistics site) have had great success in generating interesting and important discussions, I have seen too much spam on other websites, and I want to avoid having to police the untoward posts. Still, I welcome comments and I try to respond to helpful criticism. If and when I am wrong, I will gladly eat my words, which usually have been quite digestible.

Probably none of the posts here have generated more comments and criticisms than those written about the prosecution of Dr. Harkonen. In general, critics have argued that defending Harkonen and his press release was tantamount to condoning bad statistical practice. I have tried to show that Dr. Harkonen’s press release was much more revealing than it was portrayed in abbreviated accounts of his case, and the evidentiary support for his claim of efficacy in a subgroup was deeper and broader than acknowledged. The criticism and condemnation of Dr. Harkonen’s press release in the face of prevalent statistical practice, among leading journals and practitioners, is nothing short of hypocrisy and bad faith. If Dr. Harkonen deserves prison time for a press release, which promised a full analysis and discussion in upcoming conference calls and presentations at scientific meetings, then we can only imagine what criminal sanction awaits the scientists and journal editors who publish purportedly definitive accounts of clinical trials and epidemiologic studies, with subgroup analyses not prespecified and not labeled as post-hoc.

The prevalence of the practice does not transform Dr. Harkonen’s press release into “best practice,” but some allowance must be made for offering a causal opinion in the informal context of a press release rather than in a manuscript for submission to a journal. And those critics, with prosecutorial temperaments, must recognize that, when the study was presented at conferences, and when manuscript was written up and submitted to the New England Journal of Medicine, the authors did reveal the ad hoc nature of the subgroup.

The Harkonen case will remain important for several reasons. There is an important distinction in the Harkonen case, ignored and violated by the government’s position, between opinion and fact. If Harkonen is guilty of Wire Fraud, then so are virtually every cleric, minister, priest, rabbi, imam, mullah, and other religious person who makes supernatural claims and predictions. Add in all politicians, homeopaths, vaccine deniers, and others who reject evidence for superstition, who are much more culpable than a scientist who accurately reports the actual data and p-value.

Then there is the disconnect between what expert witnesses are permitted to say and what resulted in Dr. Harkonen’s conviction. If any good could come from the government’s win, it would be the insistence upon “best practice” for gatekeeping of expert witness opinion testimony.

For better or worse, scientists often describe post-hoc subgroup findings as “demonstrated” effects. Although some scientists would disagree with this reporting, the practice is prevalent. Some scientists would go further and contest the claim that pre-specified hypotheses are inherently more reliable than post-hoc hypotheses. See Timothy Lash & Jan Vandenbroucke, “Should Preregistration of Epidemiologic Study Protocols Become Compulsory?,” 23 Epidemiology 184 (2012).

One survey compared grant applications with later published papers and found that subgroup analyses were pre-specified in only a minority of cases; in a substantial majority (77%) of the subgroup analyses in the published papers, the analyses were not characterized as either pre-specified or post hoc. Chantal W. B. Boonacker, Arno W. Hoes, Karen van Liere-Visser, Anne G. M. Schilder, and Maroeska M. Rovers, “A Comparison of Subgroup Analyses in Grant

Applications and Publications,” 174 Am. J. Epidem. 291, 291 (2011). Indeed, this survey’s comparison between grant applications and published papers revealed that most of the published subgroup analyses were post hoc, and that the authors of the published papers rarely reported justifications for their post-hoc subgroup. Id.

Again, for better or worse, the practice of presenting unplanned subgroup analyses, is common in the biomedical literature. Several years ago, the New England Journal of Medicine reported a survey of publication practice in its own pages, with findings similar to those of Boonacker and colleagues. Rui Wang, Stephen W. Lagakos, James H. Ware, David J. Hunter, and Jeffrey M. Drazen, “Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials,” 357 New Eng. J. Med. 2189 (2007). In general, Wang, et al., were unable to determine the total number of subgroup analyses performed; and in the majority (68%) of trials discussed, Wang could not determine whether the subgroup analyses were prespecified. Id. at 2912. Although Wang proposed guidelines for identifying subgroup analyses as prespecified or post-hoc, she emphasized that the proposals were not “rules” that could be rigidly prescribed. Id. at 2194.

The Wang study is hardly unique; the Journal of the American Medical Association reported a similar set of results. An-Wen Chan, Asbjørn Hrobjartsson, Mette T. Haahr, Peter C. Gøtzsche, and Douglas G. Altman, “Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials Comparison of Protocols to Published Articles,” 291 J. Am. Med. Ass’n 2457 (2004). Chan and colleagues set out to document and analyze “outcome reporting bias” in studies; that is, the extent to which publications fail to report accurately the pre-specified outcomes in published studies of randomized clinical trials. The authors compared and analyzed protocols and published reports of randomized clinical trials conducted in Denmark in 1994 and 1995. Their findings document a large discrepancy between idealized notion of pre-specification of study design, outcomes, and analyses, and the actual practice revealed by later publication.

Chan identified 102 clinical trials, with 3,736 outcomes, and found that 50% of efficacy, and 65% of harm outcomes were incompletely reported. There was a statistically significant risk of statistically significant outcomes to be fully reported compared with statistically insignificant results. (pooled odds ratio for efficacy outcomes = 2.4; 95% confidence interval, 1.4 – 4.0, and pooled odds ratio for harm outcomes = 4.7; 95% confidence interval, 1.8 -12.0. Their comparison of protocols with later published articles revealed that a majority of trials (62%) had at least one primary outcome that was changed, omitted, or innovated in the published version. The authors concluded that published accounts of clinical trials were frequently incomplete, biased, and inconsistent with protocols.

This week, an international group of scientists published their analysis of agreement vel non between protocols and corresponding later publications of randomized clinical trials. Matthias Briel, DISCO study group, “Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications,” 349 Brit. Med. J. g4539 (Published 16 July 2014). Predictably, the authors found a good deal of sloppy practice, or worse. Of the 515 journal articles identified, about half (246 or 47.8%) reported one or more subgroup analysis. Of the articles that reported subgroup analyses, 81 (32.9%) publications stated that the subgroup analyses were prespecified, but in 28 of these articles (34.6%), the corresponding protocols did not identify the subgroup analysis.

In 86 of the publications surveyed, the authors found that the articles claimed a subgroup “effect,” but only 36 of the corresponding protocols reported a planned subgroup analysis. Briel and the DISCO study group concluded that protocols of randomized clinical trials insufficiently describe subgroup analyses. In over one-third of publications, the articles reported subgroup analyses not pre-specified in earlier protocols. The DISCO study group called for access to protocols and statistical analysis plans for all randomized clinical trials.

In view of these empirical data, the government’s claims against Dr. Harkonen stand out, at best, as vindictive, selective prosecution.

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Careless Scholarship About Silica History

July 21st, 2014

David Egilman is the Editor in Chief of the International Journal of Occupational and Environmental Health (IJOEH). A YouTube “selfie” interview provides some insight into Dr. Egilman’s motivations and editorial agenda. Previous posts have chronicled Egilman’s testimonial adventures because of his propensity to surface in litigations of interest. See, e.g., “David Egilman’s Methodology for Divining Causation” (Sept. 6, 2012); “Egilman Petitions the Supreme Court for Review of His Own Exclusion in Newkirk v. Conagra Foods” (Dec. 13, 2012).

Dr. Egilman has used his editorial role at the IJOEH to disseminate his litigation positions. Several of his articles are little more than his litigation reports, filed in various cases, ranging from occupational dust disease claims to pharmaceutical off-target effect claims. A recent issue of the IJOEH has yet another article of this ilk, which scatters invective across several litigations. David Egilman, Tess Bird [1], and Caroline Lee [2], “Dust diseases and the legacy of corporate manipulation of science and law, 20 Internat’l J. Occup. & Envt’l Health 115 (2014).

The article mostly concerns Egilman’s allegations that companies influenced the scientific, medical, and governmental understanding and perception of asbestos hazards. I will defer to others to address his allegations with respect to asbestos. The article, however, in its Abstract, takes broader aim at other exposures, in particular, silica:

“Knowledge that asbestos and silica were hazardous to health became public several decades after the industry knew of the health concerns. This delay was largely influenced by the interests of Metropolitan Life Insurance Company (MetLife) and other asbestos mining and product manufacturing companies.”

Egilman at 115, Abstract (emphasis added).

In their Abstract, the authors further proclaim their purpose

“To understand the ongoing corporate influence on the science and politics of asbestos and silica exposure, including litigation defense strategies related to historical manipulation of science.”

Egilman at 115. I demur for the time being with respect to asbestos, but the authors’ claims about silica are never supported in their article. A brief review of two monographs by Frederick L. Hoffman should be sufficient to condemn the authors’ carelessness to the dustbin of occupational history. Frederick L. Hoffman, Mortality from Respiratory Diseases in the Dusty Trades; Dep’t of Labor, Bureau of Labor Statistics (1918); The Problem of Dust Phthisis in the Granite Stone Industry; Dep’t of Labor, Bureau of Labor Statistics (1922). The bibliographies in both these monographs documents the widespread interest in, and awareness of, the occupational hazards of silica dusts, going back into the 19th century, among the media, the labor movement, and the non-industrial scientific community.

Not surprisingly, the authors’ conclusions are stated only in terms of asbestos hazards, knowledge, and company conduct:

“Conclusions: Asbestos product companies would like the public to believe that there was a legitimate debate surrounding the dangers of asbestos during the twentieth century, particularly regarding the link to cancer, which delayed adequate regulation. The asbestos–cancer link was not a legitimate contestation of science; rather the companies directly manipulated the scientific literature. There is evidence that industry manipulation of scientific literature remains a continuing problem today, resulting in inadequate regulation and compensation and perpetuating otherwise preventable worker and consumer injuries and deaths.”

The authors note that Rutherford Johnstone’s 1960 “seminal” textbook relied upon a study (Braun and Truan), which study Egilman attacks as corrupted by industry influence. Rutherford Johnstone & Seward E. Miller, Occupational Diseases and Industrial Medicine 328 (Philadelphia 1960). According to the Egilman, Rutherford Johnstone was the official American Medical Asociation’s consultant for occupational disease questions, which explains why he was providing answers to questions submitted to the Journal of the American Medical Association, on silica and asbestos issues. The authors note that Johnstone, in 1961, asserted that there was no epidemiologic evidence that asbestos causes lung cancer among American workers, which view reflects Johnstone’s reliance upon the Braun-Truan study. The authors fail, however, to note that Johnstone also opined that

“There is no epidemiological evidence that silicosis, resulting from undue exposure to free silica produces cancer of the lung.”

Rutherford T. Johnstone, “Silicosis and Cancer,” 176 J. Am. Med. Ass’n 81, 81 (1961). Neither the authors nor anyone else has ever shown that Johnstone was misled by any industry group with respect to his silica/lung cancer opinion.

Some of the Egilman’s scholarship is quite careless. For instance, he, along with his employees, assert that

“By the mid 1940s, the international scientific community had recognized the link between asbestos and cancer.10–18”

Readers should review all the endnotes, 10 – 18, but endnote 12 is especially interesting:

“12 Macklin MT, Macklin CC. Does chronic irritation cause primary carcinoma of the human lung? Arch Path. 1940;30:924–55.”

As I have noted before, the Macklins, and especially Dr. Madge Macklin, brought a great deal of rigor and skepticism to broad claims about the causation of lung cancer. See “Silicosis, Lung Cancer, and Evidence-Based Medicine in North America” (July 4, 2014). This citation and others do not appear to support the sweep of Egilman and his student authors’ claim.

The next mention of silica occurs in the context of an allegation that corporations (presumably not plaintiffs’ lawyers’ law firm corporations) have worked to “disguise” health concerns and influence governmental policy about several products, materials, including silica:

“During the last several decades, researchers in a wide spectrum of fields have documented the direct and purposeful efforts of corporations to disguise public health concerns and affect government policies, particularly in the tobacco, alcohol, silica, and asbestos industries, and more recently, the pharmaceutical, chemical, and ultra-processed food and drink industries.^79,73”

Egilman at 121.

The authors’ citations, however, do not support any such allegation about silica. Endnote 73[3] is an article by Egilman, and others, on Vioxx; and endnote 79[4] is an article about alcohol, tobacco, and foods. In the very next sentence, the authors further claim that:

“Corporate-funded ‘objective science’ leading to the corruption of scientific literature remains a major problem.^{65,68,69,71,73,75,80–86}”

Once again, none of the endnotes (65, 68, 69, 71, 75, and 80-86) supports the authors’ claim that anyone in the mining, milling, or marketing of crystalline silica has funded science in a way that led to the corruption of the scientific literature. Not surprisingly, the authors ignore the frauds perpetuated by litigation industry players. See, e.g., In re Silica Products Liab. Lit., 398 F. Supp. 2d 563 (S.D. Tex. 2005) (federal trial judge rebukes the litigation industry for fraudulent claiming in MDL 1553).

[1] The article acknowledges that Ms. Bird and Ms. Lee were employees of Dr. Egilman. Ms. Bird appears now to be a student in the U.K., studying medical anthropology. Ms. Bird, and Ms. Lee, appeared on earlier works by Egilman. See, e.g., David S Egilman, Tess Bird, and Caroline Lee, “MetLife and its corporate allies: dust diseases and the manipulation of science,” 19 Internat’l J. Occup. & Envt’l Health 287 (2013); David Steven Egilman, Emily Laura Ardolino, Samantha Howe, and Tess Bird, “Deconstructing a state-of-the-art review of the asbestos brake industry,” 21 New Solutions 545 (2011).

[2] Ms. Lee appears to have been employed for Egilman’s litigation consulting firm, Never Again Consulting, from 2011 until August 2013, when she entered the University of Maryland law school.

[3] Krumholz HM, Ross JS, Presler AH, Egilman DS. What have we learnt from Vioxx. Br Med J. 2007;334(7585):120–3.

[4] Moodie R, Stuckler D, Montiero C, Sheron N, Neal B, Thamarangsi T, et al. Profits and pandemics: prevention of harmful effects of tobacco, alcohol, and ultra-processed food and drink industries. Lancet. 2013;381:670–79.

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Discovery of Litigation Financing – The Jackpot Justice Finance Corporation

July 16th, 2014

Over two years ago, I wrote that courts and counsel have not done enough to adapt to the litigation industry’s use of third-party financing. See “Litigation Funding” (May 8, 2012). A few days ago, Byron Stier, at the Mass Tort Litigation Blog, posted a short news item about a recent effort to modify discovery rules to take into account the litigation industry’s business model of seeking third-party litigation funding. See “Industry Groups Seek Amendment of Rule 26 to Require Disclosure of Third Party Litigation Financing” (July 13, 2014).

Stier reported that the U.S. Chamber of Commerce Institute for Legal Reform, American Insurance Association, American Tort Reform Association, Lawyers for Civil Justice, and National Association of Manufacturers, back in April 2014, wrote a letter to the Committee on Rules of Practice and Procedure of the Administrative Office of the federal courts, to propose an amendment to Federal Rule of Civil Procedure 26(a)(1)(A). Their proposed new language is underscored, and follows 26(a)(1)(A)(i)-(iv):

“(v) for inspection and copying as under Rule 34, any agreement under which any person, other than an attorney permitted to charge a contingent fee representing a party, has a right to receive compensation that is contingent on, and sourced from, any proceeds of the civil action, by settlement, judgment or otherwise.”

This proposal is important and necessary to ensure that defendants can inquire about financial bias in jury voir dire, as well as identify bias among judges, special masters, and witnesses. Other procedural rule reforms will be needed as well. Appellate briefs should disclose financiers that have a stake in the litigation. When courts limit counsel and parties’ communications to the media about a case, such limits should apply as well to insurers and third-party financiers of the litigation efforts. Third-party financiers provide a convenient way for the litigation industry to lobby regulators and legislators, and more expansive disclosure rules are needed to capture the activities of the litigation financiers. Funding of litigation-related research by third-party financiers should be anticipated by journal editors with more expansive disclosure rules; journal editors should be alert to evolving financial markets that may influence research agendas and publications. Lawyers’ scrutiny of new clients for conflicts now requires inquiry into the veiled interests created by litigation financing.

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Too Many Narratives – Historians in the Dock

July 13th, 2014

Historical Associates Inc. (HAI) is a commercial vendor for historical services, including litigation services. Understandably, this firm, like the academic historians who service the litigation industry, takes a broad view of the desirability of historian expert witness testimony. An article in one of the HAI’s newsletters stakes out lawyer strategies in trying to prove historical facts. Lawyers can present percipient witnesses, or they

“can present the story themselves, but in the end, arguments by advocates can raise questions of bias that obscure, rather than clarify, the historical facts at issue.”

Mike Reis and Dave Wiseman, “Introducing and interpreting facts-in-evidence: the historian’s role as expert witness,” HAIpoints 1 (Summer 2010)[1]. These commercial historians recommend that advocacy bias, so clear in lawyers’ narratives, be diffused or obscured by having a professional historian present the “story.” They tout the research skills of historians: “Historians know how to find critical historical information.” And to be sure, historians, whether academic or for-hire may offer important bibliographic services, as well as help in translating, authenticating, and contextualizing documents. But these historians from HAI want a role on center-stage, or at least in the witness box. They tell us that:

“Historians synthesize information into well-documented, compelling stories.”

Ah yes, compelling stories, as in “the guiltless gust of a rattling good yarn[2].” The legal system should take a pass on such stories.

* * * * * *

A recent law review article attempts to provide a less commercial defense of expert witness testimony. See Alvaro Hasani, “Putting history on the stand: a closer look at the legitimacy of criticisms levied against historians who testify as expert witnesses,” 34 Whittier L. Rev. 343 (2013) [Hasani]. Hasani argues that historians strive to provide objective historical “interpretation,” by selecting reliable sources, and reliably reading and interpreting these sources to create a reliable “narrative.” Hasani at 355. Hasani points to some courts that have thrown up their hands and declared Daubert reliability factors inapplicable to non-scientific historian testimony. See, e.g., United States v. Paracha, No. 03 CR. 1 197(SHS), 2006 WL 12768, at *19 (S.D.N.Y. Jan. 3, 2006) (noting that Daubert is not designed for gatekeeping of a non-scientific, historian expert witness’s methodology); Saginaw Chippewa Indian Tribe of Michigan v. Granholm, 690 F. Supp. 2d 622, 634 (E.D. Mich. 2010) (noting that “[t]here is no way to ‘test’ whether the experts’ testimony concerning the historical understanding of the treaties is correct. Nor is it possible to establish an ‘error rate’ for historical experts.”).

Not all testifying historians agree, however, that their research and findings are non-scientific. Here is how one plaintiffs’ expert witness characterized historical thinking:

“Q. Do you believe that historical thinking is a form of scientific thinking?

A. I do. I think that history is sometimes classed with the humanities, sometimes classed with the social sciences, but I think there is a good deal of historical research and writing that is a form of social science.”

Examination Before Trial of Gerald Markowitz, in Mendez v. American Optical, District Court for Tarrant County, Texas (342d Judicial District), at 44:13-20 (July 19, 2005). Professor Susan Haack, and others, have made a persuasive case that the epistemic warrants for claims of knowledge, whether denominated scientific or non-scientific, are not different in kind. If historian testimony is not about knowledge of the past, then it clearly has no role in a trial. Furthermore, Professor Markowitz is correct that sometimes historical opinions are scientific in the sense that they can be tested. If a labor historian asserts that workers are exploited and subjected to unsafe work conditions due to the very nature of capitalism and the profit motives, then that historian’s opinion will be substantially embarrassed by the widespread occupational disease in European and Asian communist regimes.

When Deborah Lipstadt described historian David Irving as a holocaust denier[3], Irving sued Lipstadt for defamation. In defending against the claim, Lipstadt successfully carried the burden of proving the truth of her accusation. The trial court’s judgment, quoted by Hasani, reads like a so-called Daubert exclusion of plaintiff Irving’s putative historical writing. Irving v. Penguin Books Ltd., No. 1996-1-1113, 2000 WL 362478, at ¶¶ 1.1, 13.140 (Q.B. Apr. 11, 2000)(finding that “Irving ha[d] misstated historical evidence; adopted positions which run counter to the weight of the evidence; given credence to unreliable evidence and disregarded or dismissed credible evidence.”).

The need for gatekeeping of historian testimony should be obvious. Historian testimony is often narrative of historical fact that is not beyond the ken of an ordinary fact finder, once the predicate facts are placed into evidence. Such narratives of historical fact present a serious threat to the integrity of fact finding by creating the conditions for delegation and deferring fact finding responsibility to the historian witness, with an abdication of responsibility by the fact finder. See Ronald J. Allen, “The Conceptual Challenge of Expert Evidence,” 14 Discusiones Filosóficas 41, 50-53 (2013).

Some historians clearly believe that they are empowered by the witness chair to preach or advocate. Allan M. Brandt, who has served as a party expert witness to give testimony on many occasions for plaintiffs in tobacco cases, unapologetically described the liberties he has taken thus:

“It seems to me now, after the hopes and disappointments of the courtroom battle, that we have a role to play in determining the future of the tobacco pandemic. If we occasionally cross the boundary between analysis and advocacy, so be it. The stakes are high, and there is much work yet to do.”

Allan M. Brandt, The Cigarette Century: The Rise, Fall, and Deadly Persistance of the Product That Defined American 505 (2007).

Hasani never comes to grips with the delegation problem or with Brandt’s attitude, which is quite prevalent in the product liability arena. The problem is more than merely “occasional.” The overreaching by historian witnesses reflects the nature of their discipline, the lack of necessity for their testimony, and the failure of courts to exercise their gatekeeping. The problem with Brandt’s excuse making is that neither analysis nor advocacy is needed or desired. Advocacy is the responsibility of counsel, as well as the kind of analysis involved in much of historian testimony. For instance, when historians offer testimony about the so-called “state of the art,” they are drawing inferences from published and unpublished sources about what people knew or should have known, and about their motivations. Although their bibliographic and historical researches can be helpful to the fact finder’s effort to understand who was writing what about the issue in times past, historians have no real expertise, beyond the lay fact finder, in discerning intentions, motivations, and belief states.

Hasani concludes that the prevalence of historian expert witness testimony is growing. Hasani at 364. He cites, however, only four cases for the proposition, three of which pre-date Daubert. The fourth is an native American rights case. Hasani at 364 n.139. There is little or no evidence that historian expert witness testimony is becoming more prevalent, although it continues in product liability where state of the art — who knew what, when — remains an issue in strict liability and negligence. Mack v. Stryker Corp., 893 F. Supp. 2d 976 (D. Minn. 2012), aff’d, 748 F.3d 845 (8th Cir. 2014). There remains a need for judicial vigilance in policing such state-of-the-art testimony.

[1] Mike Reis is the Vice President and Director of Litigation Research at History Associates Inc. Mr. Reis was received his bachelor’s degree from Loyola College, and his master’s degree from George Washington University, both in history. David Wiseman, an erstwhile trial attorney, conducts historical research for History Associates.

[2] Attributed to Anthony Burgess.

[3] Deborah E. Lipstadt, Denying the Holocaust: The Growing Assault on Truth and Memory 8 (1993).

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NIEHS Transparency? We Can See Right Through You

July 10th, 2014

The recent issue of Environmental Health Perspectives contains several interesting articles on scientific methodology of interest to lawyers who litigate claimed health effects.[1] The issue also contains a commentary that argues for greater transparency in science and science policy, which should be a good thing, but yet the commentary has the potential to obscure and confuse. Kevin C. Elliott and David B. Resnik, “Science, Policy, and the Transparency of Values,” 122 Envt’l Health Persp. 647 (2014) [Elliott & Resnik].

David B. Resnik has a Ph.D., in philosophy from University of North Carolina, and his law degree from the on-line Concord University School of Law. He is currently a bioethicist and the chairman of the NIEHS Institutional Review Board. Kevin Elliott received his doctorate in the History and Philosophy of Science (Notre Dame), and he is currently an Associate Professor in Michigan State University. Elliott and Resnik advance a plea for transparency that superficially is as appealing as motherhood and apple pie. The authors argue

“that society is better served when scientists strive to be as transparent as possible about the ways in which interests or values may influence their reasoning.”

The argument appears superficially innocuous. Indeed, in addition to the usual calls for great disclosure of conflicts of interest, the authors call for more data sharing and less tendentious data interpretation:

“When scientists are aware of important background assumptions or values that inform their work, it is valuable for them to make these considerations explicit. They can also make their data publicly available and strive to acknowledge the range of plausible interpretations of available scientific information, the limitations of their own conclusions, the prevalence of various interpretations across the scientific community, and the policy options supported by these different interpretations.”

Alas, we may as well wish for the Kingdom of Heaven on Earth! An ethos or a requirement of publicly sharing data would indeed advance the most important transparency, the transparency that would allow full exploration of the inferences and conclusions claimed in a particular study. Despite their high-mindedness, the authors’ argument becomes muddled when it comes to conflating scientific objectivity with subjective values:

“In the past, scientists and philosophers have argued that the best way to maintain science’s objectivity and the public’s trust is to draw a sharp line between science and human values or policy (Longino 1990). However, it is not possible to maintain this distinction, both because values are crucial for assessing what counts as sufficient evidence and because ethical, political, economic, cultural, and religious factors unavoidably affect scientific judgment (Douglas 2009; Elliott 2011; Longino 1990; Resnik 2007, 2009).”

This argument confuses pathology of science with what actually makes science valuable and enduring. The Nazis invoked cultural arguments, explicitly or implicitly to reject “Jewish” science; religious groups in the United States invoke religious and political considerations to place creationism on an equal or superior footing with evolution; anti-vaccine advocacy groups embrace case reports over rigorous epidemiologic analyses. To be sure, these and other examples show that “ethical, political, economic, cultural, and religious factors unavoidably affect scientific judgment,” but yet science can and does transcend them. There is no Jewish or Nazi science; indeed, there is no science worthy of its name that comes from any revealed religion or cult. As Tim Minchin has pointed out, alternative medicine is either known not to work or not known to work because if alternative medicine is known to work, then we call it “medicine.” The authors are correct that these subjective influences require awareness and understanding of prevalent beliefs, prejudices, and corrupting influences, but they do not, and they should not, upset our commitment to an evidence-based world view.

Elliott and Resnik are focused on environmentalism and environmental policy, and they seem to want to substitute various presumptions, leaps of faith, and unproven extrapolations for actual evidence and valid inference, in the hope of improving the environment and reducing risk to life. The authors avoid the obvious resolution: value the environment, but acknowledge ignorance and uncertainty. Rather than allow precautionary policies to advance with a confession of ignorance, the authors want to retain their ability to claim knowledge even when they simply do not know, just because the potential stakes are high. The circularity becomes manifest in their ambiguous use of “risk,” which strictly means a known causal relationship between the “risk” and some deleterious outcome. There is a much weaker usage, popularized by journalists and environmentalists, in which “risk” refers to something that might cause a deleterious outcome. The might in “risk” here does not refer to a known probabilistic or stochastic relationship between the ex ante risk and the outcome, but rather to an uncertainty whether or not the relationship exists at all. We can see the equivocation in how the authors attempt to defend the precautionary principle:

“Insisting that chemicals should be regulated only in response to evidence from human studies would help to prevent false positive conclusions about chemical toxicity, but it would also prevent society from taking effective action to minimize the risks of chemicals before they produce measurable adverse effects in humans. Moreover, insisting on human studies would result in failure to identify some human health risks because the diseases are rare, or the induction and latency periods are long, or the effects are subtle (Cranor 2011).”

Elliott & Resnik at 648.

If there is uncertainty about the causal relationship, then by calling some exposures a “risk,” the authors prejudge whether there will be “adverse effects” at all. This is just muddled. If the relationship is uncertain, and false positive conclusions are possible, then we simply cannot claim to know that there will be such adverse effects, without assuming what we wish to prove.

The authors compound the muddle by introducing a sliding scale of “standards of evidence,” which appears to involve both variable posterior probabilities that the causal claim is correct, as well as variable weighting of types of evidence. It is difficult to see how this will aid transparency and reduce confusion. Indeed, we can see how manipulative the authors’ so-called transparency becomes in the context of evaluating causal claims in pharmaceutical approvals versus tort claims:

“Very high standards of evidence are typically expected in order to infer causal relationships or to approve the marketing of new drugs. In other social contexts, such as tort law and chemical regulation, weaker standards of evidence are sometimes acceptable to protect the public (Cranor 2008).”

Remarkably, the authors cite no statute, no case law, no legal treatise writer for the proposition that the tort law standard for causation is somehow lower than for a claim of drug efficacy before the Food and Drug Administration. The one author they cite, Carl Cranor, is neither a scientist nor a lawyer, but a philosophy professor who has served as an expert witness for plaintiffs in tort litigation (usually without transparently disclosing his litigation work). As for the erroneous identification of tort and regulatory standards, there is of course, much real legal authority to the contrary[2].

The authors go on to suggest that demanding

“the very highest standards of evidence for chemical regulation—including, for example, human evidence, accompanying animal data, mechanistic evidence, and clear exposure data—would take very long periods of time and leave the public’s health at risk.”

Elliott & Resnik at 648.

Of course, the point is that until such data are developed, we really do not know whether the public’s health is at risk. Transparency would be aided not by some sliding and slippery scale of evidence, but by frank admissions that we do not know whether the public’s health is at risk, but we choose to act anyway, and to impose whatever costs, inconvenience, and further uncertainty by promoting alternatives that are accompanied by even greater risk or uncertainty. Environmentalists rarely want to advance such wishy-washy proposals, devoid of claims of scientific knowledge that their regulations will avoid harm, and promote health, but honesty and transparency require such admissions.

The authors advance another claim in their Commentary: transparency in the form of more extensive disclosure of conflicts of interest will aid sound policy formulation. To their credit, the authors do not limit the need for disclosure to financial benefits; rather they take an appropriately expansive view:

“Disclosures of competing financial interests and nonfinancial interests (such as professional or political allegiances) also provide opportunities for more transparent discussions of the impact of potentially implicit and subconscious values (Resnik and Elliott 2013).”

Elliott & Resnik at 649. Problematically, however, when the authors discuss some specific instances of apparent conflicts, they note industry “ties,” of the authors of an opinion piece on endocrine disruptors[3], but they are insensate to the ties of critics, such as David Ozonoff and Carl Cranor, to the litigation industry, and of others to advocacy groups that might exert much more substantial positional bias and control over those critics.

The authors go further in suggesting that women have greater perceptions of risk than men, and presumably we must know whether we are being presented with a feminist or a masculinist risk assessment. Will self-reported gender suffice or must we have a karyotype? Perhaps we should have tax returns and a family pedigree as well? The call for transparency seems at bottom a call for radical subjectivism, infused with smug beliefs that want to be excused from real epistemic standards.

[1] In addition to the Elliott and Resnick commentary, see Andrew A. Rooney, Abee L. Boyles, Mary S. Wolfe, John R. Bucher, and Kristina A. Thayer, “Systematic Review and Evidence Integration for Literature-Based Environmental Health Science Assessments,” 122 Envt’l Health Persp. 711 (2014); Janet Pelley, “Science and Policy: Understanding the Role of Value Judgments,” 122 Envt’l Health Persp. A192 (2014); Kristina A. Thayer, Mary S. Wolfe, Andrew A. Rooney, Abee L. Boyles, John R. Bucher, and Linda S. Birnbaum, “Intersection of Systematic Review Methodology with the NIH Reproducibility Initiative,” 122 Envt’l Health Persp. A176 (2014).

[2] Sutera v. The Perrier Group of America, 986 F. Supp. 655, 660 (D. Mass. 1997); In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 781 (E.D.N.Y. 1984) (Weinstein, J.), aff’d, 818 F.2d 145 (2d Cir. 1987); Allen v. Pennsylvania Engineering Corp., 102 F.3d 194, 198 (5th Cir. 1996) (distinguishing regulatory pronouncements from causation in common law actions, which requires higher thresholds of proof); Glastetter v. Novartis Pharms. Corp., 107 F. Supp. 2d 1015, 1036 (E.D. Mo. 2000), aff’d, 252 F.3d 986 (8th Cir. 2001); Wright v. Willamette Indus., Inc., 91 F.3d 1105 (8th Cir. 1996); Siharath v. Sandoz Pharms. Corp., 131 F. Supp. 2d 1347, 1366 (N.D. Ga. 2001), aff’d, 295 F.3d 1194 330 (11^th Cir. 2002).

[3] Daniel R. Dietrich, Sonja von Aulock, Hans Marquardt, Bas Blaauboer, Wolfgang Dekant, Jan Hengstler, James Kehrer, Abby Collier, Gio Batta Gori, Olavi Pelkonen, Frans P. Nijkamp, Florian Lang, Kerstin Stemmer, Albert Li, KaiSavolainen, A. Wallace Hayes, Nigel Gooderham, and Alan Harvey, “Scientifically unfounded precaution drives European Commission’s recommendations on EDC regulation, while defying common sense, well-established science and risk assessment principles,” 62 Food Chem. Toxicol. A1 (2013)

Posted in Conflicts of Interest, Data Sharing, Scientific Evidence | Comments Off on NIEHS Transparency? We Can See Right Through You

Twerski’s Defense of Daubert

July 6th, 2014

Professor Aaron D. Twerski teaches torts and products liability at the Brooklyn Law School. Along with a graduating student, Lior Sapir, Twerski has published an article in which the authors mistakenly asseverate that “[t]his is not another article about Daubert.” Aaron D. Twerski & Lior Sapir, “Sufficiency of the Evidence Does Not Meet Daubert Standards: A Critique of the Green-Sanders Proposal,” 23 Widener L.J. 641, 641 (2014) [Twerski & Sapir].

A few other comments.

1. The title of the article. True, true, and immaterial. As Professor David Bernstein has pointed out many times, Daubert is no longer the law; Federal Rule of Evidence 702, a statute, is the law. Just as the original Rule 702 superseded Frye in 1975, a revised Rule 702, in 2000, superseded Daubert in 1975. See David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2013).

2. Twerski and Sapir have taken aim at a draft paper by Professors Green and Sanders, who also presented similar ideas at a workshop in March 2012, in Spain. The Green-Sanders manuscript is available on line. Michael D. Green & Joseph Sanders, “Admissibility Versus Sufficiency: Controlling the Quality of Expert Witness Testimony in the United States,” (March 5, 2012) <downloaded on March 25, 2012>. This article appears to have matured since spring 2012, but it has never progressed to parturition. Professor Green’s website suggests a mutated version is in the works: “The Daubert Sleight of Hand: Substituting Reliability, Methodology, and Reasoning for an Old Fashioned Sufficiency of the Evidence Test.”

Indeed, the draft paper is a worthwhile target. See “Admissibility versus Sufficiency of Expert Witness Evidence” (April 18, 2012). Green and Sanders pursue a reductionist approach to Rule 702, which is unfaithful to the letter and spirit of the law.

3. In their critique of Green and Sanders, Twerski and Sapir get some issues wrong. First they insist upon talking about Daubert criteria. The “criteria” were never really criteria, and as Bernstein’s scholarship establishes, it is time to move past Daubert.

4. Twerski and Sapir assert that Daubert imposes a substantial or heavy burden of proof upon the proponent of expert witness opinion testimony:

“The Daubert trilogy was intended to set a formidable standard for admissibility before one entered the thicket of evaluating whether it was sufficient to serve as grounds for recovery.”

Twerski & Sapir at 648.

Daubert instituted a “high threshold of reliability”.

Twerski & Sapir at 649.

“But, the message from the Daubert trilogy is unmistakable: a court must have a high degree of confidence in the integrity of scientific evidence before it qualifies for consideration in any formal test to be utilized in litigation.”

Twerski & Sapir at 650.

“The Daubert standard is anything but minimal.”

Twerski & Sapir at 651.

Twerski and Sapir never explain whence comes “high,” “formidable,” and “anything but minimal.” To be sure, the Supreme Court noted that “[s]ince Daubert . . . parties relying on expert evidence have had notice of the exacting standards of reliability such evidence must meet.” Weisgram v. Marley Co., 528 U.S. 440, 455 (2000) (emphasis added). An exacting standard, however, is not necessarily a heavy burden. It may be that the exacting standard is infrequently satisfied because the necessary evidence and inferences, of sufficiency quality and validity, are often missing. The truth is that science is often in the no-man’s land of indeterminate, inconclusive, and incomplete. Nevertheless, Twerski and Sapir play into the hands of the reductionist Green-Sanders’ thesis by talking about what appears to be a [heavy] burden of proof and the “weight of evidence” needed to sustain the burden.

5. Twerski and Sapir obviously recognize that reliability is different from sufficiency, but they miss the multi-dimensional aspect of expert witness opinion testimony. Consider their assertion that:

“[t]he Court of Appeals for the Eleventh Circuit in Joiner had not lost its senses when it relied on animal studies to prove that PCBs cause lung cancer. If the question was whether any evidence viewed in the light most favorable to plaintiff supported liability, the answer was probably yes.”

Twerski & Sapir at 649; see Joiner v. Gen. Electric Co., 78 F.3d 524, 532 (11th Cir. 1996) rev’d, 522 U.S. 136 (1997).

The imprecision in thinking about expert witness testimony obscures what happened in Joiner, and what must happen under the structure of the evidence statutes (or case law). The Court of Appeals never relied upon animal studies; nor did the district court below. Expert witnesses relied upon animal studies, and other studies, and then offered an opinion that these studies “prove” PCBs cause human lung cancer, and Mr. Joiner’s lung cancer in particular. Those opinions, which the Eleventh Circuit would have taken at face value, would be sufficient to support submitting the case to jury. Indeed, courts that evade the gatekeeping requirements of Rule 702 routinely tout the credentials of the expert witnesses, recite that they have used science in some sense, and that criticisms of their opinions “go to the weight not the admissibility” of the opinions. These are, of course, evasions used to dodge Daubert and Rule 702. They are evasions because the science recited is at a very high level of abstraction (“I relied upon epidemiology”), because credentials are irrelevant, and because “weight not the admissibility” is a conclusion not a reason.

Some of the issues obscured by the reductionist weight-of-the-evidence approach are the internal and external validity of the studies cited, whether the inferences drawn from the studies cited are valid and accurate, and whether the method of synthesizing conclusion from disparate studies is appropriate. These various aspects of an evidentiary display cannot be reduced to a unidimensional “weight.” Consider how many observational studies suggested, some would say demonstrated, that beta carotene supplements reduced the risk of lung cancer, only to be pushed aside by one or two randomized clinical trials.

6. Twerski and Sapir illustrate the crucial point that gatekeeping judges must press beyond the conclusory opinions by exploring the legal controversy over Parlodel and post-partum strokes. Twerski & Sapir at 652. Their exploration takes them into some of the same issues that confronted the Supreme Court in Joiner: extrapolations or “leaps of faith” between different indications, different species, different study outcomes, between surrogate end points and the end point of interest, between very high to relatively low therapeutic doses. Twerski and Sapir correctly discern that these various issues cannot be simply subsumed under weight or sufficiency.

7. Professors Green and Sanders have published a brief reply, in which they continue their “weight of the evidence” reductionist argument. Michael D. Green & Joseph Sanders, “In Defense of Sufficiency: A Reply to Professor Twerski and Mr. Sapir,” 23 Widener L.J. 663 (2014). Green and Sanders restate their position that courts can, should, and do sweep all the nuances of evidence and inference validity into a single metric – weight and sufficiency – to adjudicate so-called Daubert challenges. What Twerski and Sapir seem to have stumbled upon is that Green and Sanders are not engaged in a descriptive enterprise; they are prescribing a standard that abridges and distorts the law and best practice in order to ensure that dubious causal claims are submitted to the finder of fact.

Posted in Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on Twerski’s Defense of Daubert

Silicosis, Lung Cancer, and Evidence-Based Medicine in North America

July 4th, 2014

According to her biographies[1], Madge Thurlow Macklin excelled in mathematics, graduated from Goucher College, received a fellowship to study physiology at Johns Hopkins University, and then went on graduate with honors from the Johns Hopkins Medical School, in 1919. Along the way, she acquired a husband, Charles C. Macklin, an associate professor of anatomy at Hopkins, and had her first child.

In 1921, the Macklins moved to London, Ontario, to take positions at the University of Western Ontario. Charles received an appointment as a professor of histology and embryology, and went on to distinguish himself in pulmonary pathology. Madge Macklin received an appointment as a part-time instructor at Western, but faced decades of resistance because of her sex and her marriage to a professor. She was never promoted beyond part-time assistant professor, at Western.

Despite the hostile work environment, Madge Macklin published and lectured on statistical and medical genetics. Her papers made substantial contributions to the inheritable aspects of human cancer and other diseases.

Macklin advocated tirelessly for the inclusion of medical genetics in the American medical school curriculum. See, e.g., Marge T. Macklin, “Should The Teaching Of Genetics As Applied To Medicine Have A Place In The Medical Curriculum?” 7 J. Ass’n Am. Med. Coll. 368 (1932); “The Teaching of Inheritance of Disease to Medical Students: A Proposed Course in Medical Genetics,” 6 Ann. Intern. Med. 1335 (1933). Her advocacy largely succeeded both in medical education and in the recognition of the importance of genetics for human diseases.

Macklin’s commitment to medical genetics led her to believe that physicians had a social responsibility to engage in sensible genetics counseling, and reasonable guidance on procreation and birth control. In 1930, Macklin helped found the Eugenics Society of Canada, and went on to serve as its Director in 1935. Her writings show none of the grandiosity or pretensions that lie in creating a master race, as much as avoiding procreation among imbeciles. See, e.g., Madge Macklin, “Genetical Aspects of Sterilization of the Mentally Unfit,” 30 Can. Med. Ass’n J. 190 (1934).

Some of her biographers suggest that Macklin lost her position at Western due to her views on eugenics, and others suggest that her trenchant criticisms of the inequity of the University’s sexism led her to go to Ohio State University in 1946, as a cancer researcher, funded by the National Research Council. Macklin taught genetics at Ohio State, something that Western never permitted her to do. In 1959, three years before her death, Macklin was elected president of the American Society for Human Genetics.

By all accounts, Macklin was an extraordinary woman and a gifted scientist, but my interest in her work stems from her recognition in the 1930s and 1940s, for the need for greater rigor in drawing etiological inferences in medical science. Well ahead of her North American colleagues, Macklin emphasized the need to rule out bias, confounding, and chance before accepting apparent associations as causal. She wrote with unusual clarity and strength on the subject, decades before Sir Austin Bradford Hill. Her early mathematical prowess served her well in rebutting case reports and associations that were often embraced uncritically.

* * * * * * *

In 1939, Professor Max Klotz of the University of Toronto, reported a very crude analysis from which he inferred a putative association between silicosis and lung cancer. Max O. Klotz, “The Association of Silicosis and Carcinoma of the Lung, 35 Am. J. Cancer 38 (1939). Klotz was a pathologist, and he worked with autopsy series, without statistical tools or understanding, as was common at the time. Macklin wrote a thorough refutation, which amply illustrates her abilities and her clear thinking:

“Another type of improper control for analysing cancer data arises through ignoring the fact that every cancer has a specific age incidence, and sex predilection. I have already mentioned breast, uterine and prostatic cancers, but other types of cancer, not of the generative organs, have marked sex predilection. Cancer of the lung is a good example. It occurs four times as frequently in the male as in the female. If we desire to make any study of causative factors in lung cancer we must be sure that our control group is comparable to our experimental group. Again I will take an example from the literature. A worker was investigating the possible role of silicosis in inducing lung cancer. He compared the incidence of lung cancer in a group of 50 cases of silicosis, and in a large necropsy group of 4500 ‘unselected’ cases from a general hospital. He found that lung cancer was 7 times as frequent in the silicosis group as in the unselected necropsies. This is an excellent example of misunderstanding as to what is meant by ‘random’ sample. Because the 4500 necropsies were ‘unselected’ the worker thought that he had a good control group. As a matter of fact, in order to have a good control, he needed to select very carefully from these 4500 necropsies, those which he was to use as his standard. He forgot two things:

(1) that lung cancer is 4 times as common in the male as in the female and that all his silicosis cases were males, therefore his unselected necropsies should have been highly selected to contain only males. Assuming that half of his 4500 necropsies were females, and that among them one fifth of the lung cancers occurred, one can easily show that had his control group been all males as was his silicosis group, lung cancer would have been only 4.8 times as common among the silicosis patients as among the general necropsy group instead of 7 times as he found it.

(2) The second thing he forgot is that silicosis does not develop until 15 or 20 years of exposure have passed by. That placed all his silicosis patients in the late forties or early fifties, just when lung cancer becomes most common. Many of his general necropsy group were in the age range below 45, hence not in the lung cancer age. He should have selected only those males from the necropsy group who matched the age distribution of his silicosis patients. If he then found a significantly higher percentage of lung cancer among his silicosis patients he could have suggested a relationship between the two. Until that control group is properly studied, his results are valueless.”

****

SUMMARY

* * *

“The second point to be noted is that the control group should correspond as nearly as possible in all respects with the group under investigation, with the single exception of the etiologic factor being investigated. If silicosis is being considered as a causative agent in lung cancer, the control group should be as nearly like the experimental or observed group as possible in sex, age distribution, race, facilities for diagnosis, other possible carcinogenic factors, etc. The only point in which the control group should differ in an ideal study would be that they were not exposed to free silica, whereas the experimental group was. The incidence of lung cancer could then be compared in the two groups of patients.

This necessity is often ignored; and a ‘random’ control group is obtained for comparison on the assumption that any group taken at random is a good group for comparison. Fallacious results based on such studies are discussed briefly.”

Madge Thurlow Macklin, “Pitfalls in Dealing with Cancer Statistics, Especially as Related to Cancer of the Lung,” 14 Diseases Chest 525 532-33, 529-30 (1948).

The recognition that uncontrolled, or improperly controlled, research was worthless was a great advance in thinking about medical causation. In the 1940s, Macklin was ahead of her time; indeed, if she were alive today, she would be ahead of many contemporary epidemiologists.

——

[1]Barry Mehler, “Madge Thurlow Macklin,” from Barbara Sicherman and Carl Hurd Green, eds., Notable American Women: The Modern Period 451-52 (1980); Laura Lynn Windsor, Women in Medicine: An Encyclopedia 134 (2002).

[1] Barry Mehler, “Madge Thurlow Macklin,” from Barbara Sicherman and Carl Hurd Green, eds., Notable American Women: The Modern Period 451-52 (1980); Laura Lynn Windsor, Women in Medicine: An Encyclopedia 134 (2002).

Posted in Causation | Comments Off on Silicosis, Lung Cancer, and Evidence-Based Medicine in North America

Zoloft MDL Excludes Proffered Testimony of Anick Bérard, Ph.D.

June 27th, 2014

Anick Bérard is a Canadian perinatal epidemiologist in the Université de Montréal. Bérard was named by plaintiffs’ counsel in the Zoloft MDL to offer an opinion that selective serotonin reuptake inhibitor (SSRI) antidepressants as a class, and Zoloft (sertraline) specifically, cause a wide range of birth defects. Bérard previously testified against GSK about her claim that paroxetine, another SSRI antidepressant is a teratogen.

Pfizer challenged Bérard’s proffered testimony under Federal Rules of Evidence 104(a), 702, 703, and 403. Today, the Zoloft MDL transferee court handed down its decision to exclude Dr. Bérard’s testimony at the time of trial. In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL 2342, Document 979 (June 27, 2014). The MDL court acknowledged the need to consider the selectivity (“cherry picking”) of studies upon which Dr. Bérard relied, as well as her failure to consider multiple comparisons, ascertainment bias, confounding by indication, and lack of replication of specific findings across the different SSRI medications, and across studies. Interestingly, the MDL court recognized that Dr. Bérard’s critique of studies as “underpowered” was undone by her failure to consider available meta-analyses or to conduct one of her own. The MDL court seemed especially impressed by Dr. Bérard’s having published several papers that rejected a class effect of teratogenicity for all SSRIs, as recently as 2012, while failing to identify anything that was published subsequently that could explain her dramatic change in opinion for litigation.

Posted in Causation, Expert Witnesses, Meta-analysis, Rule 702, Scientific Misconduct | Comments Off on Zoloft MDL Excludes Proffered Testimony of Anick Bérard, Ph.D.

Stanford Conference on Mathematics in Court

June 26th, 2014

Last month, The Stanford Center for Legal Informatics hosted a conference, “Trial With and Without Mathematics: Legal, Philosophical, and Computational Perspectives.” The conference explored the what if any role mathematics plays in the law, and in the training and education of lawyers.

The program was organized by Marcello Di Bello (Stanford Univ., Department of Philosophy), and Bart Verheij (Stanford Univ., CodeX Center for Legal Informatics, and Univ. of Groningen, Institute of Artificial Intelligence). DiBello teaches an undergraduate course, Probability and the Law, at Stanford.

The program featured presentations by:

Sandy L. Zabell (Northwestern Univ.) on “A Tribe of Skeptics: Probability and the 19th Century Law of Evidence,” (Slides; Video), with commentary by Andrea Roth (Univ. California, Berkeley School of Law);

Susan Haack (Univ. of Miami School of Law), on “Legal Probabilism: An Epistemological Dissent,” (Slides; Video), with commentary by Charles H. Brenner (Univ. California, Berkeley School of Law) (Slides);

William C. Thompson (Univ. California, Irvine Dep’t Criminology, Law & Society), on “How Should Forensic Scientists Explain Their Evidence to Juries: Match Probabilities, Likelihood Ratios, or ‘Verbal Equivalents’?” (Slides; Video), with commentary by Paul Brest (Stanford Law School);

Henry Prakken (Univ. Groningen), on “Models of Legal Proof and Their Cognitive Plausibility,” (Slides; Video), with commentary by Sarah B. Lawsky (Univ. California, Irvine, School of Law) (Slides);

Vern Walker (Hofstra Univ. School of Law), on “Computational Representation of Legal Reasoning at the Law-Fact Interface,” (Slides; Video), with commentary by Bart Verheij (Slides); and

Ronald J. Allen (Northwestern Univ. School of Law) presented on “What Are We Doing? Reconsidering Juridical Proof Rules,” (Slides; Video), with commentary by Marcello Di Bello.

An interesting collection of presentations and commentary, which I have not yet reviewed carefully. Professor Haack’s presentation seems to cover much the same ground covered at a conference on Standards of Proof and Scientific Evidence, held at the University of Girona, in Spain. Her previous lecture can be viewed on-line, and a manuscript of Haack’s paper is available , as well. Susan Haack, “Legal Probabilism: An Epistemological Dissent” (2011)(cited here as “Haack”). See “Haack Attack on Legal Probabilism” (2012).

Professor Haack’s papers and presentations on law, legal evidence, and probability are slated for republication in book form, this August. Susan Haack, Evidence Matters: Science, Proof, and Truth in the Law (Cambridge 2014). The contents look familiar:

1. Epistemology and the law of evidence: problems and projects

2. Epistemology legalized: or, truth, justice, and the American way

3. Legal probabilism: an epistemological dissent

4. Irreconcilable differences? The troubled marriage of science and law

5. Trial and error: two confusions in Daubert

6. Federal philosophy of science: a deconstruction – and a reconstruction

7. Peer review and publication: lessons for lawyers

8. What’s wrong with litigation-driven science?

9. Proving causation: the weight of combined evidence

10. Correlation and causation: the ‘Bradford Hill Criteria’ in epidemiological, legal, and epistemological perspective

11. Risky business: statistical proof of specific causation

12. Nothing fancy: some simple truths about truth in the law

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