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David Egilman RIP – Part Two

April 28th, 2024

There was a good bit of irony in Egilman’s reaching out to me to help him prepare for my deposition of him in a silicone gel breast implant case. First, the materials he apparently wanted were all in a document repository for the benefit of plaintiffs’ lawyers. He needed only to have asked the Wilentz firm lawyers for relevant. In rather typical fashion, Egilman wanted to create a faux issue about defense counsel’s hiding the ball.

Second, Egilman had already completed his report, and his request showed that his opinions had been asserted without looking at material documents.

Third, and perhaps most important, in New Jersey, attorneys are not generally allowed to communicate with a represented party directly.[1] Expert witnesses are usually considered as agents of the parties that retained them, which means that such witnesses are also not free to communicate directly with the adverse parties or its counsel. There was no exact precedent for Egilman’s misconduct, but it was obviously disturbing to plaintiffs’ counsel, who promptly withdrew Egilman as a witness in the case. Alas, I did not get my chance to conduct this examination before trial.

Much of the irony in the New Jersey situation derived from Egilman’s fancying himself  something of an ethicist. He certainly was quick to pronounce ethical judgments upon others, especially anyone in manufacturing industry, or any scientist who served as an expert witness opposite him. As he made clear at his CSPI lecture, Egilman had an ideological bias, and it deeply affected his judgment of science and history. He swam in the hogwash of critical theory, cultural hegemony, and Marxist cant.

To Egilman, it was obvious that material forces of capitalism meant that manufacturing industry was incapable of honestly defending its products. The motives, biases, and depradations of the lawsuit industry and its agents rarely concerned him. As a committed socialist, Egilman was incurious about how and why occupational and environmental diseases were so prevalent in socialist and communist countries, where profits are outlawed and the people own the means of production.[2]

Like the radical labor historians David Rosner and Gerald Markowitz, Egilman tried to cram the history of silicosis (and even silicosis litigation) into a Marxist narrative of class conflict, economic reductionism, and capitalist greed. Egilman’s ideological bias marred his attempts to relate the history of dust diseases. His bias made him a careless historian. Several of his attempts to relate the history of dust diseases were little more than recycled litigation reports, previously  filed in various cases, with footnotes added. Egilman was occasionally listed as an expert witness in silicosis cases, but he glibly and ignorantly lumped the history of silica with that of asbestos diseases. In one article, for example, he wrote:

“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.”[3]

Egilman’s claims about silica, however, were never supported in this article or elsewhere. A brief review of two published monographs by Frederick L. Hoffman, published before 1923, should be sufficient to condemn the authors’ carelessness to the dustbin of occupational history.[4]  The bibliographies in both these monographs document 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. The conversation about silicosis was on full display in the national silicosis conference of 1938, sponsored by Secretary of Labor Francis Perkins.

On at least one occasion, Egilman publicly acknowledged his own entrepreneurial and profit motives. In a consumer diacetyl exposure case (claiming bronchiolitis obliterans), a federal district court excluded Egilman’s causation opinions as unreliable. The court found that Egilman had manipulated data to reach misleading conclusions, devoid of scientific validity.[5]

Egilman was so distraught by being excluded that he sought to file a personal appeal to the United States Court of Appeal.[6] When the defendant-appellee opposed Egilman’s motion to intervene in the plaintiff’s appeal, Egilman stridently asserted his right to participate,[7] and filed his own declaration.[8] The declaration is required reading for anyone who wants to understand Egilman’s psycho-pathology.

In what was nothing short of a scurrilous pleading, Egilman attacked the district judge for having excluded him from testifying. He went so far as to claim that the judge had defamed him with derogatory comments about his “methodology.” If Egilman’s challenge to the trial judge was not bizarre enough, Egilman also claimed a right to intervene in the appeal by advancing the claim that the Rule 702 exclusion hurt his livelihood.  The following language is from paragraph 11 of Dr. Egilman’s declaration in support of his motion:

“The Daubert ruling eliminates my ability to testify in this case and in others. I will lose the opportunity to bill for services in this case and in others (although I generally donate most fees related to courtroom testimony to charitable organizations, the lack of opportunity to do so is an injury to me). Based on my experience, it is virtually certain that some lawyers will choose not to attempt to retain me as a result of this ruling. Some lawyers will be dissuaded from retaining my services because the ruling is replete with unsubstantiated pejorative attacks on my qualifications as a scientist and expert. The judge’s rejection of my opinion is primarily an ad hominem attack and not based on an actual analysis of what I said – in an effort to deflect the ad hominem nature of the attack the judge creates ‘strawman’ arguments and then knocks the strawmen down, without ever addressing the substance of my positions.”

Egilman was a bit coy about how much of his fees went to him, and how much went to charity. To give the reader some idea of the artificial flavor of Egilman’s pomposity, paragraph 8 of his remarkable declaration avers”

“My views on the scientific standards for the determination of cause-effect relationships (medical epistemology) have been cited by the Massachusetts Supreme Court (Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1 (1998)):

Although there was conflicting testimony at the Oregon hearing as to the necessity of epidemiological data to establish causation of a disease, the judge appears to have accepted the testimony of an expert epidemiologist that, in the absence of epidemiology, it is ‘sound science…. to rely on case reports, clinical studies, in vivo tests and animal tests.’ The judge may also have relied on the affidavit of the plaintiff’s epidemiological expert, Dr. David S. Egilman, who identified several examples in which disease causation has been established based on animal and clinical case studies alone to demonstrate that ‘doctors utilize epidemiological data as one tool among many ’.”

Egilman’s quote from the Vassallo decision is accurate as far as it goes,[9] but the underlying assertion is either a lie or a grand self-delusion. There was epidemiologic evidence on silicone and connective tissue disease before the Oregon federal district court and its technical advisors, and the court resoundingly rejected the plaintiffs’ causal claims as unsupported by valid evidence, with or without epidemiologic evidence. The argument that epidemiology was unnecessary came from Dr. Egilman’s affidavit, and the plaintiffs’ counsel’s briefs, which were considered and rejected by Judge Jones.[10]

Egilman’s affidavit in connection with the so-called Oregon hearings, which took place during the summer of 1996, was not a particularly important piece of evidence. Most of the “regulars” had put in reports or affidavits in the Hall case. Egilman failed to appear at the proceedings before the court and its technical advisors; and he was not mentioned by name in the Hall decision. Nonetheless, Judge Jones, in his published decision, clearly rejected all the plaintiffs’ witnesses and affiants, including Egilman, in their efforts to make a case for silicone as a cause of autoimmune disease.

A few months after the Oregon hearings, Judge Weinstein, in the fall of 1996, along with other federal and state judges, held a “Daubert” hearing on the admissibility of expert witness opinion testimony in breast implant cases, pending in New York state and federal courts.  Egilman’s affidavit on causation was once again in play. Plaintiffs’ counsel suggested that Egilman might testify, but he was once again a no show. Egilman’s affidavit was in the record, and the multi-judge panel considered and rejected the claimed causal connection between silicone and autoimmune or connective tissue diseases.[11]

There is more, however, to the disingenuousness of Dr. Egilman’s citation to the Vassallo case.  The Newkirk court, in receiving his curious declaration, would not likely have known that Vassallo was a silicone gel breast implant case, and one may suspect that Dr. Egilman wanted to keep the Ninth Circuit uninformed of his role in the silicone litigation. After all, by 1999, The Institute of Medicine (now the National Academies of Science, Engineering, and Medicine) delivered its assessment of the safety of silicone breast implants.  Egilman’s distorted and exaggerated claims had been rejected.[12]

Alas, the jingle of coin doth not always soothe the hurt that conscience must feel. In his declaration, Egilman sought to temper the unfavorable judgment in the Newkirk diacetyl case by noting that only judges who had not previously encountered him would be unduly persuaded by Judge Peterson’s decision. Other judges who have heard him hold forth in court would no doubt see him for the brilliant crusading avenger that he is. The feared prejudice:

“will generally not occur in cases heard before Judges where I have already appeared as a witness. For example a New York state trial judge has praised plaintiffs’ molecular-biology and public-health expert Dr. David Egilman as follows: ‘Dr. Egilman is a brilliant fellow and I always enjoy seeing him and I enjoy listening to his testimony . . . . He is brilliant, he really is.’ [Lopez v. Ford Motor Co., et al. (120954/2000; In re New York City Asbestos Litigation, Index No. 40000/88).]”[13]

The United States Court of Appeals did not appear to hold Egilman the intervenor as brilliant as he thought himself. The court was not moved by either the bullying or the braggadocio.[14] The curious appeal was denied.

Egilman obviously could not sue the trial or appellate judges in the Newkirk case, but he did on other occasions try to deflect or diminish criticism by threats of litigation. In 2009, Laurence Hirsh, a physician, formerly with Merck, wrote a commentary for the Mayo Clinic Proceedings, on conflicts of interest. His commentary was a sustained critique of the hypocrisy and anti-industry bias of journals’ requirements for disclosure of conflict of interest.[15] Hirsch pointed out that some of the authors, including David Egilman, who had written articles critical of Merck, had given anemic disclosures of their own biases and conflicts of interest. Hirsch noted that Egilman had testified in many different litigations (too many diverse litigations to be credible for any one witness), including “silicone breast implants and connective tissue disease (characterized as the epitome of junk science)….”[16] With respect to compensation, Hirsch reported that:

“Egilman has testified for Mr Lanier and other attorneys in more than 100 tort cases (nearly always for plaintiffs) for approximately 2 decades and, by his own estimate, has earned $20 to $25 million for such testimony. Besides dollars, Egilman’s objectivity is questionable on other grounds. In 2007, he signed an admission that ‘there was another side to the story’ and was fined $100,000 by an outraged federal judge for actively facilitating the leak (through a third party) to a New York Times reporter (exclusively) of court-sealed documents in litigation involving Eli Lilly (Indianapolis, IN) and olanzapine (Zyprexa).”[17]

Hirsch’s commentary was a burr under the saddle of this lawsuit industry work horse. Egilman wrote to Hirsch to demand that he correct and retract his comments. Egilman threatened to sue Dr. Hirsch for false and defamatory statements. Alas, Hirsch was intimidated by the threats. The correction that resulted was shaped by Egilman’s assertions, and what resulted was false and misleading:

“1. Dr Egilman’s income from serving as a medical expert in tort litigation, etc, was incorrectly reported as $20-$25 million during a 20-year period. Dr Egilman actually testified in court that it was $2-$2.5 million during that time. The source for the original statement in the Commentary was an online newspaper article dated July 31, 2005. The newspaper revised its report of the court testimony by Dr Egilman in a correction that was published only in the local, printed edition on August 2, 2005 (Michael Morris, oral communication, September 11, 2009).

2. Dr Egilman was not fined by a judge for leaking court sealed documents concerning the Lilly-Zyprexa litigation. Rather, Dr Egilman and Lilly entered into an (Stipulated) agreement by US District Judge Jack Weinstein, filed September 9, 2007, in which Dr Egilman agreed to pay Lilly $100,000, and to dismiss his appeal of the Court’s Final Judgment, Order and Injunction from February and March, 2007 (http://lawprofessors.typepad.com/tortsprof/files/EgilmanSettlement.pdf).

3. Dr Egilman has not testified in court in breast implant and connective tissue disease, or in antidepressant or antipsychotic drug cases. Dr Egilman did provide a sworn affidavit in one case involving local effects of leakage of silicone from breast implants (Vassallo vs Baxter Healthcare Corporation. Decisions of the Supreme Judicial Court of Massachusetts. May 5-July 16, 1998, p. 7).

I regret these inaccuracies in my Commentary.”[18]

Egilman’s estimate of his income, without access to his tax returns, was essentially worthless. The difference between a fine and a stipulated penalty was meaningless. The claim that Egilman did not testify in the Vassallo trial, in which the plaintiff claimed that she had developed atypical autoimmune disease as a result of her silicone gel breast implants, was simply a lie that Egilman foisted upon Dr. Hirsch.

Falsus in uno, falsus in omnibus.

[1] See Formal Opinion 503, of the ABA’s Standing Committee on Ethics and Professional Responsibility, ABA Model Rule of Professional Conduct 4.02.

[2] See, e.g., Jie Li, Peng Yin, Haidong Wang, Lijun Wang, Jinling You, Jiangmei Liu, Yunning Liu, Wei Wang, Xiao Zhang, Piye Niu, and Maigeng Zhou, “The burden of pneumoconiosis in China – analysis Global Burden of Disease Study,” 22 BMC Pub. Health 1114 (2022); Na Wu, Chang Jiang Xue, Shiwen Yu, and Qiao Ye, “Artificial stone-associated silicosis in China: A prospective comparison with natural stone-associated silicosis,” 25 Respirology 518 (2019); Christa Schröder, Friedrich Klaus, Martin Butz, Dorothea Koppisch, and Otten Heinz, “Uranium mining in Germany: incidence of occupational diseases 1946-1999,” 75 Internat’l Arch. Occup. & Envt’l Health 235 (2002); A.G. Chebotarev, “Incidence of silicosis and the effectiveness of preventive measures at the Balei mines (1947 to 1967),” 13 Gigiena truda i professional’nye zabolevaniia 14 (1969) (in Russian); C. Hadjioloff, “The Development of Silicosis and Its Expert Evaluation as a Basis for the Rehabilitation of Silicosis Patients in Bulgaria,” 58 Medizinische Klinik 2023 (1963).

[3] David Egilman, Tess Bird, and Caroline Lee, “Dust diseases and the legacy of corporate manipulation of science and law, 20 Internat’l J. Occup. & Envt’l Health 115, 115 (2014) (emphasis added).

[4] 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). See also U.S. Department of Labor Bulletin No. 21, part I, National Silicosis Conference, Report on Medical Control (1938).

[5] Newkirk v. Conagra Foods, Inc., 727 F.Supp. 2d 1006 (E.D. Wash. 2010).

[6] Schachtman, “Exclusion of Dr. David Egilman in Diacetyl Case,” Tortini (June 20, 2011); “David Egilman’s Methodology for Divining Causation,” Tortini (Sept. 6, 2012).

[7] Opposition of David Egilman to Motion for Order to Show Cause re Dismissal of Appeal for Lack of Standing, in case no. 10-35667, document 7547640 (9th Cir. Nov. 16, 2010).

[8] Declaration of David Egilman, in Support of Opposition to Motion for Order to Show Cuase Why Appeal Should Not Be Dismissed for Lack of Standing, in case no. 10-35667, document 7547640 (9th Cir. Nov. 16, 2010) Declaration [Declaration].

[9] Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1, 12 (1998).

[10] See Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. 1996). Judge Jones made his views very clear:  contrary to Egilman’s affidavit, epidemiology was needed, but lacking, in the plaintiffs’ case.

[11] Transcript at p.159:7-18, from Nyitray v. Baxter Healthcare Corp., CV 93-159 (E.D.N.Y. Oct. 9, 1996) (pre-trial hearing before Judge Jack Weinstein, Justice Lobis, and Magistrate Cheryl Pollak). See In re Breast Implant Cases, 942 F. Supp. 958 (E.& S.D.N.Y. 1996) (rejecting sufficiency of plaintiffs’ causation expert witness evidence, which included affidavit of Dr. Egilman). Years later, Judge Jack B. Weinstein elaborated upon his published breast-implant decision, with a bit more detail about how he viewed the plaintiffs’ expert witnesses. Judge Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in silicone litigation as “charlatans”; “[t]he breast implant litigation was largely based on a litigation fraud. … Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”) Egilman, who had filed an affidavit in support of the plaintiffs’ claims in the Hall case, and in the cases before Judge Weinstein, was within the scope of that litigation fraud.

[12] Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (1999).

[13] Declaration at p. 9 n. 2.

[14] Newkirk v. Conagra Foods, Inc. 727 F.Supp. 2d 1006 (E.D. Wash. 2010), aff’d, 438 Fed.Appx. 607 (9th Cir.2011); Egilman v. Conagra Foods, Inc., 2012 WL 3836100 (9th Cir. 2012), cert. denied, 568 U.S. 1229 (2013).

[15] Laurence J. Hirsch, “Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals,” 84 Mayo Clin. Proc. 811 (2009).

[16] Id. at 815.

[17] Id. at 814 (internal citations omitted).

[18] Laurence J. Hirsch, “Corrections,” 85 Mayo Clin. Proc. 99 (2010).

Posted in Conflicts of Interest, Expert Witness Hall of Shame, Expert Witnesses, Historian Testimony, Silica | 29 Comments »

David Egilman, Rest in Peace – Part 1

April 26th, 2024

After close to a 40 year career as a testifying expert witness, David Egilman died earlier this month.[1] He was a work horse of the lawsuit industry.  Although he made plenty of money as a retained witness, Egilman was motivated by his political agenda. As he noted in a 2004 lecture at the Center for Science in the Public Interest: “my bias is ideological.”[2]

By the mid-1980s, Egilman was actively engaged in medico-legal testimonial adventures. In 1986, he was sued for negligence and fraud in connection with medical reports he wrote to support worker compensation claims filed against the Dayton-Walther Corporation. Thanks to the excellent lawyering of Frank Woodside and others, the case was ultimately dismissed on grounds that the alleged fraud was not legally cognizable as pleaded.[3]

Not long after Egilman dodged the Ohio fraud case, he testified for a claimant in a disability case against the Norfolk & Western Railroad. The administrative tribunals found the claim “was not fully credible or supported by substantial evidence in the record.”[4] By 1990, testifying in the Virgin Islands, Egilman had appeared upon the asbestos scene. [5] And then, Egilman seemed to be everywhere.

With the decision in Daubert, Egilman became gun shy, and he would not appear in courtrooms in which he faced a substantial risk of being excluded.  Egilman submitted reports in the cases before Judge Jones, in the District of Oregon, but after the court appointed technical advisors, Egilman decided to stay on the east coast. Egilman also sat out the hearings before Judges Weinstein and Baer, and Justice Lobis, in Brooklyn, in October 1996.

Up to the fall of 1996, Egilman had never showed up in any my cases. As I was preparing for the hearing before Judge Weinstein, I received a letter by telecopy and post, from David Egilman. The circumstances surrounding this letter were nothing less than bizarre. Earlier in the winter of 1996, George Gore (Al’s cousin) tried a silicone breast implant case for Bristol Myers Squibb in Oregon state court. I was there for the trial, mostly to monitor the proceedings, and help with witness preparation. Tragically, George’s father died during the trial, and for want of a better candidate, I substituted for him while he had to be away. When George returned (after a detour to be invested as President of the IADC), he wanted his case back.  After some tussling, we agreed to share the remaining witnesses, but George was adamant that he wanted to present the closing argument.

With the jury out, the defense prospects did not look promising, and George vamoosed again. The case had been bifurcated, and there was a punitive damages phase still to go. Once again, I re-entered the fray and tried the second phase of the case. In its deliberations on the second phase, the jury deadlocked, and the parties were left to fight what the Oregon requirement of a unified jury meant.

And then, in late September 1996, a faxed letter came across my desk, from none other than David Egilman. I had a breast implant case, set for trial in Middlesex County, New Jersey, and Egilman was one of the main  causation expert witnesses for the plaintiff, represented by the Wilentz firm. Perhaps the only way to tell what happened is simply to share with you what Egilman wanted from me, and then to share with you my response to the Wilentz firm. Very shortly after I wrote my letter, Chris Placitella, the Wilentz trial lawyer, withdrew Egilman from the case, and I never got another opportunity to take his deposition or to cross-examine him.

 

And my response directed to the firm that represented the plaintiff:

 

 

 

[1] Clay Risen, “David Egilman, Doctor Who Took On Drug Companies, Dies at 71,” N.Y. Times (Apr. 15, 2024).

[2] David Egilman and Susanna Rankin Bohme, “The suppression of science: How corporate interests hide the truth & how to stop them” CSPI Conference (July 2004).

[3] Dayton-Walther Corp. v. Kelly, 42 Ohio App. 3d 184 (1987).

[4] Freels v. U.S. RR Retirement Bd., 879 F.2d 335 (1989).

[5] Dunn v. Owens-Corning Fiberglas, 774 F. Supp. 929 (D.V.I. 1991).

Posted in Asbestos, Cognitive Biases, Expert Witness Hall of Shame, Public Nuisances | 5 Comments »

Access to a Study Protocol & Underlying Data Reveals a Nuclear Non-Proliferation Test

April 8th, 2024

The limits of peer review ultimately make it a poor proxy for the validity tests posed by Rules 702 and 703. Published peer review articles simply do not permit a very searching evaluation of the facts and data of a study. In the wake of the Daubert decision, expert witnesses quickly saw that they can obscure the search for validity by the reliance upon published studies, and frustrate the goals of judicial gatekeeping. As a practical matter, the burden shifts to the party that wishes to challenge the relied upon facts and data to learn more about the cited studies to show that the facts and data are not sufficient under Rule 702(b), and that the testimony is not the product of reliable methods under Rule 702(c). Obtaining study protocols, and in some instances, underlying data, are necessary for due process in the gatekeeping process. A couple of case studies may illustrate the power of looking under the hood of published studies, even ones that were peer reviewed.

When the Supreme Court decided the Daubert case in June 1993, two recent verdicts in silicone-gel breast implant cases were fresh in memory.[1] The verdicts were large by the standards of the time, and the evidence presented for the claims that silicone caused autoimmune disease was extremely weak. The verdicts set off a feeding frenzy, not only in the lawsuit industry, but also in the shady entrepreneurial world of supposed medical tests for “silicone sensitivity.”

The plaintiffs’ litigation theory lacked any meaningful epidemiologic support, and so there were fulsome presentations of putative, hypothetical mechanisms. One such mechanism involved the supposed in vivo degradation of silicone to silica (silicon dioxide), with silica then inducing an immunogenic reaction, which then, somehow, induced autoimmunity and the induction of autoimmune connective tissue disease. The degradation claim would ultimately prove baseless,[2] and the nuclear magnetic resonance evidence put forward to support degradation would turn out to be instrumental artifact and deception. The immunogenic mechanism had a few lines of potential support, with the most prominent at the time coming from the laboratories of Douglas Radford Shanklin, and his colleague, David L. Smalley, both of whom were testifying expert witnesses for claimants.

The Daubert decision held out some opportunity to challenge the admissibility of testimony that silicone implants led to either the production of a silicone-specific antibody, or the induction of t-cell mediated immunogenicity from silicone (or resulting silica) exposure. The initial tests of the newly articulated standard for admissibility of opinion testimony in silicone litigation did not go well.[3]  Peer review, which was absent in the re-analyses relied upon in the Bendectin litigation, was superficially present in the studies relied upon in the silicone litigation. The absence of supportive epidemiology was excused with hand waving that there was a “credible” mechanism, and that epidemiology took too long and was too expensive. Initially, post-Daubert, federal courts were quick to excuse the absence of epidemiology for a novel claim.

The initial Rule 702 challenges to plaintiffs’ expert witnesses thus focused on  immunogenicity as the putative mechanism, which if true, might lend some plausibility to their causal claim. Ultimately, plaintiffs’ expert witnesses would have to show that the mechanism was real by showing that silicone exposure causes autoimmune disease through epidemiologic studies,

One of the more persistent purveyors of a “test” for detecting alleged silicone sensitivity came from Smalley and Shanklin, then at the University of Tennessee. These authors exploited the fears of implant recipients and the greed of lawyers by marketing a “silicone sensitivity test (SILS).” For a price, Smalley and Shanklin would test mailed-in blood specimens sent directly by lawyers or by physicians, and provide ready-for-litigation reports that claimants had suffered an immune system response to silicone exposure. Starting in 1995, Smalley and Shanklin also cranked out a series of articles at supposedly peer reviewed journals, which purported to identify a specific immune response to crystalline silica in women who had silicone gel breast implants.[4] These studies had two obvious goals. First, the studies promoted their product to the “silicone sisters,” various support groups of claimants, as well as their lawyers, and a network of supporting rheumatologists and plastic surgeons. Second, by identifying a putative causal mechanism, Shanklin could add a meretricious patina of scientific validity to the claim that silicone breast implants cause autoimmune disease, which Shanklin, as a testifying expert witness, needed to survive Rule 702 challenges.

The plaintiffs’ strategy had been to paper over the huge analytical gaps in their causal theory with complicated, speculative research, which had been peer reviewed and published. Although the quality of the journals was often suspect, and the nature of the peer review obscure, the strategy had been initially successful in deflecting any meaningful scrutiny.

Many of the silicone cases were pending in a multi-district litigation, MDL 926, before Judge Sam Pointer, in the Northern District of Alabama. Judge Pointer, however, did not believe that ruling on expert witness admissibility was a function of an MDL court, and by 1995, he started to remand cases to the transferor courts, for those courts to do what they thought appropriate under Rules 702 and 703. Some of the first remanded cases went to the District of Oregon, where they landed in front of Judge Robert E. Jones. In early 1996, Judge Jones invited briefing on expert witness challenges, and in face of the complex immunology and toxicology issues, and the emerging epidemiologic studies, he decided to appoint four technical advisors to assist him in deciding the challenges.

The addition of scientific advisors to the gatekeeper’s bench made a huge difference in the sophistication and detail of the challenges that could be lodged to the relied-upon studies. In June 1996, Judge Jones entertained extensive hearings with viva voce testimony from both challenged witnesses and subject-matter experts on topics, such as immunology and nuclear magnetic resonance spectroscopy. Judge Jones invited final argument in the form of videotaped presentations from counsel so that the videotapes could be distributed to his technical advisors later in the summer. The contrived complexity of plaintiffs’ case dissipated, and the huge analytical gaps became visible. In December 1996, Judge Jones issued his decision that excluded the plaintiffs’ expert witnesses’ proposed testimony on grounds that it failed to satisfy the requirements of Rule 702.[5]

In October 1996, while Judge Jones was studying the record, and writing his opinion in the Hall case, Judge Weinstein, with a judge from the Southern District of New York, and another from New York state trial court, conducted a two-week Rule 702 hearing, in Brooklyn. Judge Weinstein announced at the outset that he had studied the record from the Hall case, and that he would incorporate it into his record for the cases remanded to the Southern and Eastern Districts of New York.

Curious gaps in the articles claiming silicone immunogenicity, and the lack of success in earlier Rule 702 challenges, motivated the defense to obtain the study protocols and underlying data from studies such as those published by Shanklin and Smalley. Shanklin and Smalley were frequently listed as expert witnesses in individual cases, but when requests or subpoenas for their protocols and raw data were filed, plaintiffs’ counsel stonewalled or withdrew them as witnesses. Eventually, the defense was able to enforce a subpoena and obtain the protocol and some data. The respondents claimed that the control data no longer existed, and inexplicably a good part of the experimental data had been destroyed. Enough was revealed, however, to see that the published articles were not what they claimed to be.[6]

In addition to litigation discovery, in March 1996, a surgeon published the results of his test of the Shanklin-Smalley silicone sensitivity test (“SILS”).[7] Dr. Leroy Young sent the Shanklin laboratory several blood samples from women with and without silicone implants. For six women who never had implants, Dr. Young submitted a fabricated medical history that included silicone implants and symptoms of “silicone-associated disease.” All six samples were reported back as “positive”; indeed, these results were more positive than the blood samples from the women who actually had silicone implants. Dr. Young suggested that perhaps the SILS test was akin to cold fusion.

By the time counsel assembled in Judge Weinstein’s courtroom, in October 1996, some epidemiologic studies had become available and much more information was available on the supposedly supportive mechanistic studies upon which plaintiffs’ expert witnesses had previously relied. Not too surprisingly, plaintiffs’ counsel chose not to call the entrepreneurial Dr. Shanklin, but instead called Donard S. Dwyer, a young, earnest immunologist who had done some contract work on an unrelated matter for Bristol-Myers Squibb, a defendant in the litigation.  Dr. Dwyer had filed an affidavit previously in the Oregon federal litigation, in which he gave blanket approval to the methods and conclusions of the Smalley-Shanklin research:

“Based on a thorough review of these extensive materials which are more than adequate to evaluate Dr. Smalley’s test methodology, I formed the following conclusions. First, the experimental protocols that were used are standard and acceptable methods for measuring T Cell proliferation. The results have been reproducible and consistent in this laboratory. Second, the conclusion that there are differences between patients with breast implants and normal controls with respect to the proliferative response to silicon dioxide appears to be justified from the data.”[8]

Dwyer maintained this position even after the defense obtaining the study protocol and underlying data, and various immunologists on the defense side filed scathing evaluatons of the Smalley-Shanklin work.  On direct examination at the hearings in Brooklyn, Dwyer vouched for the challenged t-cell studies, and opined that the work was peer reviewed and sufficiently reliable.[9]

The charade fell apart on cross-examination. Dwyer refused to endorse the studies that claimed to have found an anti-silicone antibody. Researchers at leading universities had attempted to reproduce the findings of such antibodies, without success.[10] The real controversy was over the claimed finding of silicone antigenicity as shown in t-cell or the cell-mediated specific immune response. On direct examination, plaintiffs’ counsel elicited Dwyer’s support for the soundness of the scientific studies that purported to establish such antigenicity, with little attention to the critiques that had been filed before the hearing.[11] Dwyer stuck to his unqualified support he had expressed previously in his affidavit for the Oregon cases.[12]

The problematic aspect of Dwyer’s direct examination testimony was that he had seen the protocol and the partial data produced by Smalley and Shanklin.[13] Dwyer, therefore, could not resist some basic facts about their work. First, the Shanklin data failed to support a dose-response relationship.[14] Second, the blood samples from women with silicone implants had been mailed to Smalley’s laboratory, whereas the control samples were collected locally. The disparity ensured that the silicone blood samples would be older than the controls, which was a departure from treating exposed and control samples in the same way.[15] Third, the experiment was done unblinded; the laboratory technical personnel and the investigators knew which blood samples were silicone exposed and which were controls (except for samples sent by Dr. Leroy Young).[16] Fourth, Shanklin’s laboratory procedures deviated from the standardized procedure set out in the National Institute of Health’s Current Protocols in Immunology.[17]

The SILS study protocol and the data produced by Shanklin and Smalley made clear that each sample was to be tested in triplicate for t-cell proliferation in response to silica, to a positive control mitogen (Con A), and to a negative control blank. The published papers all claimed that the each sample was tested in triplicate for each of these three response situations (silica, mitogen, and nothing).[18] Shanklin and Smalley described their t-cell proliferation studies, in their published papers, as having been done in triplicate. These statements were, however, untrue and never corrected.[19]

The study protocol called for the tests to be run in triplicate, but they instructed the laboratory that two counts may be used if one count does not match the other counts, which is to be decided by a technical specialist on a “case-by-case” basis. Of data that was supposed to be reported in triplicate, fully one third had only two data points, and 10 percent had but one data point.[20] No criteria were provided to the technical specialist for deciding which data to discard.[21] Not only had Shanklin excluded data, but he discarded and destroyed the data such that no one could go back and assess whether the data should have been excluded.[22]

Dwyer agreed that this exclusion and discarding of data was not at all a good method.[23] Dwyer proclaimed that he had not come to Brooklyn to defend this aspect of the Shanklin work, and that it was not defensible at all. Dwyer conceded that “the interpretation of the data and collection of the data are flawed.”[24] Dwyer tried to stake out a position that was incoherent by asserting that there was “nothing inherently wrong with the method,” while conceding that discarding data was problematic.[25] The judges presiding over the hearing could readily see that the Shanklin research was bent.

At this point, the lead plaintiffs’ counsel, Michael Williams, sought an off-ramp. He jumped to his feet and exclaimed “I’m informed that no witness in this case will rely on Dr. Smalley’s [and Shanklin’s] work in any respect.” [26] Judge Weinstein’s eyes lit up with the prospect that the Smalley-Shanklin work, by agreement, would never be mentioned again in New York state or federal cases. Given how central the claim of silicone antigenicity was to plaintiffs’ cases, the defense resisted the stipulation about research that they would continue to face in other state and federal courts. The defense was saved, however, by the obstinence of a lawyer from the Weitz & Luxenberg firm, who rose to report that her firm intended to call Drs. Shanklin and Smalley as witnesses, and that they would not stipulate to the exclusion of their work. Judge Weinstein rolled his eyes, and waved me to continue.[27] The proliferation of the t-cell test was over. The hearing before Judges Weinstein and Baer, and Justice Lobis, continued for several more days, with several other dramatic moments.[28]

In short order, on October 23, 1996, Judge Weinstein issued a short, published opinion, in which he granted partial summary judgment on the claims of systemic disease for all cases pending in federal court in New York.[29] What was curious was that the defendants had not moved for summary judgment. There were, of course, pending motions to exclude plaintiffs’ expert witnesses, but Judge Weinstein effectively ducked those motions, and let it be known that he was never a fan of Rule 702. It would be many years later, before Judge Weinstein allowed his judicial assessment see the light of day. Two decades and some years later, in a law review article, Judge Weinstein gave his judgment that

“[t]he breast implant litigation was largely based on a litigation fraud. …  Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”[30]

Judge Weinstein’s opinion was truly a judgment from which there can be no appeal. Shanklin and Smalley continued to publish papers for another decade. None of the published articles by Shanklin and others have been retracted.

[1] Reuters, “Record $25 Million Awarded In Silicone-Gel Implants Case,” N.Y. Times at A13 (Dec. 24, 1992) (describing the verdict returned in Harris County, Texas, in Johnson v. Medical Engineering Corp.); Associated Press, “Woman Wins Implant Suit,” N.Y. Times at A16 (Dec. 17, 1991) (reporting a verdict in Hopkins v. Dow Corning, for $840,000 in compensatory and $6.5 million in punitive damages); see Hopkins v. Dow Corning Corp., 33 F.3d 1116 (9th Cir. 1994) (affirming judgment with minimal attention to Rule 702 issues).

[2] William E. Hull, “A Critical Review of MR Studies Concerning Silicone Breast Implants,” 42 Magnetic Resonance in Medicine 984, 984 (1999) (“From my viewpoint as an analytical spectroscopist, the result of this exercise was disturbing and disappointing. In my judgement as a referee, none of the Garrido group’s papers (1–6) should have been published in their current form.”). See also N.A. Schachtman, “Silicone Data – Slippery & Hard to Find, Part 2,” Tortini (July 5, 2015). Many of the material science claims in the breast implant litigation were as fraudulent as the health effects claims. See, e.g., John Donley, “Examining the Expert,” 49 Litigation 26 (Spring 2023) (discussing his encounters with frequent testifier Pierre Blais, in silicone litigation).

[3] See, e.g., Hopkins v. Dow Corning Corp., 33 F.3d 1116 (9th Cir. 1994) (affirming judgment for plaintiff over Rule 702 challenges), cert. denied, 115 S.Ct. 734 (1995). See Donald A. Lawson, “Note, Hopkins v. Dow Corning Corporation: Silicone and Science,” 37 Jurimetrics J. 53 (1996) (concluding that Hopkins was wrongly decided).

[4] See David L. Smalley, Douglas R. Shanklin, Mary F. Hall, and Michael V. Stevens, “Detection of Lymphocyte Stimulation by Silicon Dioxide,” 4 Internat’l J. Occup. Med. & Toxicol. 63 (1995); David L. Smalley, Douglas R. Shanklin, Mary F. Hall, Michael V. Stevens, and Aram Hanissian, “Immunologic stimulation of T lymphocytes by silica after use of silicone mammary implants,” 9 FASEB J. 424 (1995); David L. Smalley, J. J. Levine, Douglas R. Shanklin, Mary F. Hall, Michael V. Stevens, “Lymphocyte response to silica among offspring of silicone breast implant recipients,” 196 Immunobiology 567 (1996); David L. Smalley, Douglas R. Shanklin, “T-cell-specific response to silicone gel,” 98 Plastic Reconstr. Surg. 915 (1996); and Douglas R. Shanklin, David L. Smalley, Mary F. Hall, Michael V. Stevens, “T cell-mediated immune response to silica in silicone breast implant patients,” 210 Curr. Topics Microbiol. Immunol. 227 (1996). Shanklin was also no stranger to making his case in the popular media. See, e.g., Douglas Shanklin, “More Research Needed on Breast Implants,” Kitsap Sun at 2 (Aug. 29, 1995) (“Widespread silicone sickness is very real in women with past and continuing exposure to silicone breast implants.”) (writing for Scripps Howard News Service). Even after the Shanklin studies were discredited in court, Shanklin and his colleagues continued to publish their claims that silicone implants led to silica antigenicity. David L. Smalley, Douglas R. Shanklin, and Mary F. Hall, “Monocyte-dependent stimulation of human T cells by silicon dioxide,” 66 Pathobiology 302 (1998); Douglas R. Shanklin and David L. Smalley, “The immunopathology of siliconosis. History, clinical presentation, and relation to silicosis and the chemistry of silicon and silicone,” 18 Immunol. Res. 125 (1998); Douglas Radford Shanklin, David L. Smalley, “Pathogenetic and diagnostic aspects of siliconosis,” 17 Rev. Environ Health 85 (2002), and “Erratum,” 17 Rev Environ Health. 248 (2002); Douglas Radford Shanklin & David L Smalley, “Kinetics of T lymphocyte responses to persistent antigens,” 80 Exp. Mol. Pathol. 26 (2006). Douglas Shanklin died in 2013. Susan J. Ainsworth, “Douglas R. Shanklin,” 92 Chem. & Eng’g News (April 7, 2014). Dr. Smalley appears to be still alive. In 2022, he sued the federal government to challenge his disqualification from serving as a laboratory director of any clinical directory in the United States, under 42 U.S.C. § 263a(k). He lost. Smalley v. Becerra, Case No. 4:22CV399 HEA (E.D. Mo. July 6, 2022).

[5] Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Ore. 1996); see Joseph Sanders & David H. Kaye, “Expert Advice on Silicone Implants: Hall v. Baxter Healthcare Corp., 37 Jurimetrics J. 113 (1997); Laurens Walker & John Monahan, “Scientific Authority: The Breast Implant Litigation and Beyond,” 86 Virginia L. Rev. 801 (2000); Jane F. Thorpe, Alvina M. Oelhafen, and Michael B. Arnold, “Court-Appointed Experts and Technical Advisors,” 26 Litigation 31 (Summer 2000); Laural L. Hooper, Joe S. Cecil & Thomas E. Willging, “Assessing Causation in Breast Implant Litigation: The Role of Science Panels,” 64 Law & Contemp. Problems 139 (2001); Debra L. Worthington, Merrie Jo Stallard, Joseph M. Price & Peter J. Goss, “Hindsight Bias, Daubert, and the Silicone Breast Implant Litigation: Making the Case for Court-Appointed Experts in Complex Medical and Scientific Litigation,” 8 Psychology, Public Policy &  Law 154 (2002).

[6] Judge Jones’ technical advisor on immunology reported that the studies offered in support of the alleged connection between silicone implantation and silicone-specific T cell responses, including the published papers by Shanklin and Smalley, “have a number of methodological shortcomings and thus should not form the basis of such an opinion.” Mary Stenzel-Poore, “Silicone Breast Implant Cases–Analysis of Scientific Reasoning and Methodology Regarding Immunological Studies” (Sept. 9, 1996). This judgment was seconded, over three years later, in the proceedings before MDL 926 and its Rule 706 court-appointed immunology expert witness. See Report of Dr. Betty A. Diamond, in MDL 926, at 14-15 (Nov. 30, 1998). Other expert witnesses who published studies on the supposed immunogenicity of silicone came up with some creative excuses to avoid producing their underlying data. Eric Gershwin consistently testified that his data were with a co-author in Israel, and that he could not produce them. N.A. Schachtman, “Silicone Data – Slippery and Hard to Find, Part I,” Tortini (July 4, 2015). Nonetheless, the court-appointed technical advisors were highly critical of Dr. Gershwin’s results. Dr. Stenzel-Poore, the immunologist on Judge Jones’ panel of advisors, found Gershwin’s claims “not well substantiated.” Hall v. Baxter Healthcare Corp., 947 F.Supp. 1387 (D. Ore. 1996). Similarly, Judge Pointer’s appointed expert immunologist Dr. Betty A. Diamond, was unshakeable in her criticisms of Gershwin’s work and his conclusions. Testimony of Dr. Betty A. Diamond, in MDL 926 (April 23, 1999). And the Institute of Medicine committee, charged with reviewing the silicone claims, found Gershwin’s work inadequate and insufficient to justify the extravagent claims that plaintiffs were making for immunogenicity and for causation of autoimmune disease. Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants 256 (1999). Another testifying expert witness who relied upon his own data, Nir Kossovsky, resorted to a seismic excuse; he claimed that the Northridge Quake destroyed his data. N.A. Schachtman, “Earthquake Induced Data Loss – We’re All Shook Up,” Tortini (June 26, 2015); Kossovsky, along with his wife, Beth Brandegee, and his father, Ram Kossowsky, sought to commercialize an ELISA-based silicone “antibody” biomarker diagnostic test, Detecsil. Although the early Rule 702 decisions declined to take a hard at Kossovsky’s study, the U.S. Food and Drug Administration eventually shut down the Kossovsky Detecsil test. Lillian J. Gill, FDA Acting Director, Office of Compliance, Letter to Beth S. Brandegee, President, Structured Biologicals (SBI) Laboratories: Detecsil Silicone Sensitivity Test (July 15, 1994); see Gary Taubes, “Silicone in the System: Has Nir Kossovsky really shown anything about the dangers of breast implants?” Discover Magazine (Dec. 1995).

[7] Leroy Young, “Testing the Test: An Analysis of the Reliability of the Silicone Sensitivity Test (SILS) in Detecting Immune-Mediated Responses to Silicone Breast Implants,” 97 Plastic & Reconstr. Surg. 681 (1996).

[8] Affid. of Donard S. Dwyer, at para. 6 (Dec. 1, 1995), filed in In re Breast Implant Litig. Pending in U.S. D. Ct, D. Oregon (Groups 1,2, and 3).

[9] Notes of Testimony of Dr. Donnard Dwyer, Nyitray v. Baxter Healthcare Corp., CV 93-159 (E. & S.D.N.Y and N.Y. Sup. Ct., N.Y. Cty. Oct. 8, 9, 1996) (Weinstein, J., Baer, J., Lobis, J., Pollak, M.J.).

[10] Id. at N.T. 238-239 (Oct. 8, 1996).

[11] Id. at N.T. 240.

[12] Id. at N.T. 241-42.

[13] Id. at N.T. 243-44; 255:22-256:3.

[14] Id. at 244-45.

[15] Id. at N.T. 259.

[16] Id. at N.T. 258:20-22.

[17] Id. at N.T. 254.

[18] Id. at N.T. 252:16-254.

[19] Id. at N.T. 254:19-255:2.

[20] Id. at N.T. 269:18-269:14.

[21] Id. at N.T. 261:23-262:1.

[22] Id. at N.T. 269:18-270.

[23] Id. atN.T. 256:3-16.

[24] Id. at N.T. 262:15-17

[25] Id. at N.T. 247:3-5.

[26] Id. at N.T. at 260:2-3

[27] Id. at N.T. at 261:5-8.

[28] One of the more interesting and colorful moments came when the late James Conlon cross-examined plaintiffs’ pathology expert witness, Saul Puszkin, about questionable aspects of his curriculum vitae. The examination was revealed such questionable conduct that Judge Weinstein stopped the examination and directed Dr. Puszkin not to continue without legal counsel of his own.

[29] In re Breast Implant Cases, 942 F. Supp. 958 (E.& S.D.N.Y. 1996). The opinion did not specifically address the Rule 702 and 703 issues that were the subject of pending motions before the court.

[30] Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (emphasis added).

Posted in Data Sharing, Expert Witness Hall of Shame, Rule 702, Rule 703, Scientific Misconduct, Scientific Publishing | 43 Comments »

Dipak Panigrahy – Expert Witness & Putative Plagiarist

March 27th, 2024

Citing an IARC monograph may be in itself questionable, given the IARC’s deviations from good systematic review practice. Taking the language of an IARC, monograph, and passing it off as your own, without citation or attribution, and leaving out the qualifications and limitations stated in the monograph, should be disqualifying for an expert witness.

And in one federal court, it is.

Last week, on March 18, Senior Judge Roy Bale Dalton, Jr., of Orlando, Florida, granted defendant Lockheed Martin’s Rule 702 motion to exclude the proffered testimony of Dr. Dipak Panigrahy.[1] Panigraphy had opined in his Rule 26 report that seven substances[2] present in the Orlando factory cause eight different types of cancer[3] in 22 of the plaintiffs. Lockheed’s motion asserted that Panigrahy copied IARC verbatim, except for its qualifications and limitations. Judge Dalton reportedly found Panigraphy’s conduct so “blatant that it represents deliberate lack of candor” and an “unreliable methodology.” Although Judge Dalton’s opinion is not yet posted on Westlaw or Google Scholar,[4] the report from Legal Newsline quoted the opinion extensively:

“Here, there is no question that Dr. Panigrahy extensively plagiarized his report… .”

“And his deposition made the plagiarism appear deliberate, as he repeatedly outright refused to acknowledge the long swaths of his report that quote other work verbatim without any quotation marks at all – instead stubbornly insisting that he cited over 1,100 references, as if that resolves the attribution issue (it does not).”

“Indeed, the plagiarism is so ubiquitous throughout the report that it is frankly overwhelming to try to make heads or tails of just what is Dr. Panigrahy’s own work – a task that neither he nor Plaintiffs’ counsel even attempts to tackle.”

There is a wide-range of questionable research practices and dubious inferences that lead to the exclusion of expert witnesses under Rule 702, but I would have thought that Panigraphy was the first witness to have been excluded for plagiarism. Judge Dalton did, however, cite cases involving plagiarism by expert witnesses.[5] Although plagiarism might be framed as a credibility issue, the extent of the plagiarism by Panigraphy represented such an egregious lack of candor that it may justify exclusion under Rule 702.

Judge Dalton’s gatekeeping analysis, however, did not stop with the finding of blatant plagiarism from the IARC monograph. Panigraphy’s report was further methodologically marred by reliance upon the IARC, and his confusion of the IARC hazard evaluation with the required determination of causation in the law of torts. Judge Dalton explained that

“the plagiarism here reflects even deeper methodological problems because the report lifts a great deal of its analysis from IARC in particular. As the Court discussed in the interim causation Order, research agencies like IARC are, understandably, focused on protecting public health and recommending protective standards, rather than evaluating causation from an expert standpoint in the litigation context. IARC determines qualitatively whether substances are carcinogenic to humans; its descriptors have “no quantitative significance” such as more likely than not. Troublingly, Dr. Panigrahy did not grasp this crucial distinction between IARC’s classifications and the general causation preponderance standard. Because so much of Dr. Panigrahy’s report is merely a wholesale adoption of IARC’s findings under the guise of his own expertise, and IARC’s findings in and of themselves are insufficient, he fails to reliably establish general causation.”[6]

Dr. Panigraphy was accepted into medical school at the age of 17. His accelerated education may have left him without a firm understanding of the ethical requirements of scholarship.

Earlier this month, Senior Judge Dalton excluded another expert witness’s opinion testimony, from Dr. Donald Mattison, on autism, multiple sclerosis, and Parkinson’s disease, but permitted opinions on the causation of various birth defects.[7] Judge Dalton’s decisions arise from a group of companion cases, brought by more than 60 claimants against Lockheed Martin for various health conditions alleged to have been caused by Lockheed’s supposed contamination of the air, soil, and groundwater, with chemicals from its weapons manufacturing plant.

The unreliability of Panigraphy’s report led to the entry of summary judgment against the 22 plaintiffs, whose cases turned on the Panigraphy report.

The putative plagiarist, Dr. Panigraphy, is an assistant professor of pathology, at Harvard Medical School, in the department of pathology, Beth Israel Deaconess Medical Center, in Boston.  “The Expert Institute” has a profile of Panigraphy, with a compilation of background information and litigation activities. His opinions were excluded in the federal multi-district litigation concerning Zantac/ranitidine.[8]  Very similar opinions were permitted over defense challenges, in a short, perfunctory order, even shorter on reasoning, in the valsartan multi-district litigation.[9]

[1] John O’Brien, “‘A mess’: Expert in Florida toxic tort plagiarizes cancer research of others, tries to submit it to court,” Legal News Line (Mar. 25, 2024).

[2] trichloroethylene, tetrachloroethylene, formaldehyde, arsenic, hexavalent chromium, trichloroethylene, and styrene.

[3] cancers of the kidney, breast, thyroid, pancreas, liver and bile duct, testicles, and anus, as well as Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, and leukemia.

[4] Henderson v. Lockheed Martin Corp., case no. 6:21-cv-1363-RBD-DCI, document 399 (M.D. Fla. Mar. 18, 2024) (Dalton, S.J.).

[5] Henderson Order at 6, citing Moore v. BASF Corp., No. CIV.A. 11-1001, 2012 WL 6002831, at *7 (E.D. La. Nov. 30, 2012) (excluding expert testimony from Bhaskar Kura), aff’d, 547 F. App’x 513 (5th Cir. 2013); Spiral Direct, Inc. v. Basic Sports Apparel, Inc., No. 6:15-cv-641, 2017 WL 11457208, at *2 (M.D. Fla. Apr. 13, 2017); 293 F. Supp. 3d 1334, 1363 n. 20 (2017); Legier & Materne v. Great Plains Software, Inc., No. CIV.A. 03-0278, 2005 WL 2037346, at *4 (E.D. La. Aug. 3, 2005) (denying motion to exclude proffered testimony because expert witness plagiarized a paragraph in his report).

[6] Henderson Order at 8 -10 (internal citations omitted), citing McClain v. Metabolife Internat’l, Inc., 401 F.3d 1233, 1249 (11th Cir. 2005) (distinguishing agency assessment of risk from judicial assessment of causation); Williams v. Mosaic Fertilizer, LLC, 889 F.3d 1239, 1247 (11th Cir. 2018) (identifying “methodological perils” in relying extensively on regulatory agencies’ precautionary standards to determine causation); Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 198 (5th Cir. 1996) (noting that IARC’s “threshold of proof is reasonably lower than that appropriate in tort law, which traditionally makes more particularized inquiries into cause and effect and requires a plaintiff to prove that it is more likely than not that another individual has caused him or her harm”); In re Roundup Prods. Liab. Litig., 390 F. Supp. 3d 1102, 1109 (N.D. Cal. 2018) (“IARC classification is insufficient to get the plaintiffs over the general causation hurdle.”), aff’d, 997 F.3d 941 (9th Cir. 2021).

[7] John O’Brien, “Autism plaintiffs rejected from Florida Lockheed Martin toxic tort,” Legal Newsline (Mar. 15, 2024).

[8][8] In re Zantac (ranitidine) Prods. Liab. Litig., MDL NO. 2924 20-MD-2924, 644 F. Supp. 3d 1075, 1100 (S.D. Fla. 2022).

[9] In re Valsartan, Losartan, and Irbesartan Prods. Liab. Litig., Case 1:19-md-02875-RBK-SAK, document 1958 (D.N.J. Mar. 4, 2022).

Posted in Causation, Expert Witness Hall of Shame, Expert Witnesses, Rule 702, Scientific Misconduct | 102 Comments »

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 »

Epistemic Virtue – Dropping the Dime on Tenpenny

July 18th, 2021

When Marjorie Taylor Greene came under fire for propagating lies about Jewish space lasers and other fantastical conspiracy theories, she did not apologize. Rather she turned the opproprium into a grievance about being “allowed” to believe the lies. Blaming the media, Greene complained: “I was allowed to believe things that weren’t true… .”[1]

In a stunning show of bad faith, Greene attempted to redirect fault to the media. Beneath the failed attempt was a stratagem that appears to have prevalent appeal in this day of electronic and social media. There are some people who believe that telling a lie may be a moral failing, but believing a lie simply means you have been victimized. And being a victim is the ticket for admission into our grievance society.

Greene’s transparent attempt to foist blame on those who would allow her to believe hateful and crazy sidesteps her personal responsibility for her beliefs, and ignores that she chose to propagate the pernicious claims. Greene’s metaphor of passivity is essentially false in failing to come to grips with how we form beliefs, curate them, test, and verify them, even before we take to the social media “airways” to publish or re-publish them.

For the last few years, there has been scholarly and popular criticism of social media for its ability to propagate falsehoods, lies, conspiracy theories, and dis-, mis-, and mal-information.[2] Clearly, social media can do these things, but is it really surprising that social media can be an information cesspool? Descriptively, we can acknowledge that people are influenced by false claims made on social media platforms. Prescriptively, we can, and should, hold people to higher standards.

Earlier this week, the United States Surgeon General, Dr. Vivek Murthy proclaimed health misinformation on social media to be “urgent threat.”[3] Dr. Murthy stated that tech and social media companies needed to fight information rot more aggressively, and the Surgeon General’s office issued an advisory about “building a healthy information environment.”[4] Later last week, President Biden criticized social media companies for their failure to control misinformation, and announced a plan for government to participate in fact checking claims made on social media.[5] Biden’s initiative may be creating the state action needed for the yutzballs on the right and the left to make out state action in their claims of unconstitutional censorship.

I hate to play the “what about” game that was made so popular during the Trump Administration, but I have moments of weakness. What about governmental platforms for speech? After centuries of allowing any willing, able, and marginally qualified person, with a reasonable pretense to expertise, to give opinions in court, the federal judicial system cracked down on unsound, poorly supported expert witness opinion testimony. Most state courts dragged their judicial feet, but at least uttered in dicta that they were concerned.

Legislative platforms for speech have no gatekeeper. Any quack can show up, and she does. Take Sherri Jane Tenpenny.  Please.

Sherri Tenpenny is an osteopathic physician who is a well-known, virulent disease vector of disinformation. In its March 2021 report, The Disinformation Dozen, the Center for Countering Digital Hate identified Tenpenny as a top anti-vaccination shyster. As a social media vector, she is ranked in the top dozen “influencers.”[6]

Tenpenny is an anti-vaccination osteopathic physician, who shakes down fearful parents at vaccination bootcamps, and hangs out with internet hoodlums such as Alex Jones, and the plumped-up pillow purveyor, Mike Lindell. She is the author of the 2008 book, Saying No to Vaccines: A Resource Guide for all Ages, where you can find hyperbolic claims, such as “[t]he skyrocketing autism epidemic, controversy surrounding mercury and thimerosal, and the rampant childhood epidemics — asthma, allergies, eczema, attention deficit disorders (ADD), attention deficit hyperactivity disorders (ADHD) and cancer — have been linked to vaccines.”

In federal court, Tenpenny has been blocked from disseminating her malarkey at the gate. In one case, Tenpenny served as an expert witness in support of a claim that a man’s receipt of a hepatitis B vaccination caused him to develop Guillain-Barré syndrome. The Special Master incorrectly wrote that the law required him to presume the admissibility of Tenpenny’s proffered testimony. The law actually requires the proponent to show the admissibility of his expert witness’s opinion testimony. But even with the non-existent presumption, Tenpenny’s opinion was ultimately found to be worth less than a plugged nickel, when the Special Master found her methodology “so divergent from the scientific method as to be nonsensical and confusing.”[7]

In other branches of government, a Tenpenny can go a lot further. Last month, the Ohio legislature invited Tennpenny to testify in support of House Bill 248, Enact Vaccine Choice and Anti-Discrimination Act (June 8, 2021). Introduced into the Ohio House of Representatives by Republican member Jennifer Gross, Bill 248 would “prohibit mandatory vaccinations and vaccination status disclosures.” Indeed, the proposed legislation would prohibit requiring, or creating incentives for, any vaccines, not just vaccinations against SARS-CoV-2. Tenpenny’s testimony did not fail to disappoint.

Tenpenny claimed that vaccines “magnetize” people, such that keys and spoons will stick to their bodies:

“I’m sure you’ve seen the pictures all over the Internet of people who have had these shots and now they’re magnetized. They can put a key on their forehead. It sticks. They can put spoons and forks all over them and they can stick, because now we think that there’s a metal piece to that.”

Tenpenny did not, however, discuss the obvious issue of polarity, and whether people would line up “north” to “south,” when together in a crowd. She vaguely suggested that “[t]here’s been people who have long suspected that there’s been some sort of an interface, yet-to-be-defined interface, between what’s being injected in these shots and all of the 5G towers.”[8]

The fallout from the Tenpenny testimony has been amusing. After the hearing, another Republican, Representative Scott Lipps, blamed Gross for having invited Tenpenny. During the hearing, however, none of the legislators strongly pushed back. Republican legislators thanked her for testifying, and praised her work as “enlightening.” The bill sponsor, Jennifer Gross, who trained as a nurse, told Tennpenny that it was “an honor to have you here.” According to some media reports (sorry), Gross previously compared businesses’ requiring vaccination to the Holocaust. Importantly, none of the legislators asked her for the studies upon which she relied.

Why would anyone think that Facebook, Twitter, or YouTube would act with more epistemic virtue than the Ohio Legislature? The Tenpenny phenomenon raises other interesting and important questions. Tenpenny has been licensed in Ohio as a “D.O.” (Doctor of Osteopathy), no. 34.003789, since 1984. Her online record shows no “board actions” taken or pending. Apparently, the state of Ohio, the American Osteopathic Association, and other professional and regulatory bodies do not see a problem with Tenpenny’s performance in the Ohio House of Representatives.

The American Medical Association (AMA) recognizes that medical evidence in legal and administrative proceedings is critical, and that physicians have a duty to assist.[9] Testifying for a legislative committee would certainly qualify for a legal proceeding. Testifying is the practice of medicine, and physicians who testify must do so “honestly,” with “continuous self-examination to ensure that their testimony represents the facts of the case,” and “only in areas in which they have appropriate training and recent, substantive experience and knowledge.”[10] The AMA Ethical Guidelines further provide that a testifying physician has a responsibility to ensure that his or her testimony “reflects current scientific thought and standards of care that have gained acceptance among peers in the relevant field.”[11]

Perhaps most important, the AMA Ethical Guidelines specify that medical societies and medical licensing boards are responsible for maintaining high standards for medical testimony, and must assess “claims of false or misleading testimony.” When the testimony is false or misleading, these bodies should discipline the offender “as appropriate.”[12]

Where are the adults in the room?

[1] Josh K. Elliott, “GOP’s Marjorie Taylor Greene regrets being ‘allowed’ to believe hoaxes,” Global News Canada (Feb. 4, 2021).

[2] See, e.g., Catherine D. Tan, “Defending ‘snake oil’: The preservation of contentious knowledge and practices,” 51 Social Studies of Science 538 (2021).

[3] Sheryl Gay Stolberg & Davey Alba, “Surgeon General Assails Tech Companies Over Misinformation on Covid-19,” N.Y. Times (July 15, 2021).

[4] Vivek H. Murthy, Health Misinformation: The U.S. Surgeon General’s Advisory on

Building a Healthy Information Environment (2021).

[5] The Associated Press, “Biden Slams Social Media Companies for Pandemic Misinformation,” N.Y. Times (July 16, 2021).

[6] Jonathan Jarry, “A Dozen Misguided Influencers Spread Most of the Anti-Vaccination Content on Social Media: The Disinformation Dozen generates two thirds of anti-vaccination content on Facebook and Twitter,” McGill Univ. Office for Science & Soc’y (Mar. 31, 2021).

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

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

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

[10] Id.

[11] Id.

[12] Id.

Posted in Expert Witness Hall of Shame, Expert Witnesses, Public Nuisances, Scientific Misconduct | 1 Comment »

Dr. Harry Shubin – Asbestos Litigation Hall of Shame

February 19th, 2021

Many physicians took and failed the so-called B-reader examination for proficiency in using the International Labor Office’s grading schema of chest radiographs for pneumoconiosis. Famously, Irving Selikoff was someone who took but failed this examination, and he stopped serving as a clinical expert witness in asbestos cases. No one can say for sure whether there was cause and effect. In Philadelphia, South Jersey pulmonary physician, Dr. Joseph Sokolowski, was a frequent testifier for plaintiffs, despite his having failed the B-Reader examination three times. Sokolowski was conditionally fined and disqualified from testifying in Philadelphia because of his refusal to comply with compulsory process for his B-Reader test results.[1]

The only physician I encountered who lied outright about his B-reader examination results was the late Harry Shubin. Some people may know of Dr. Shubin only because of the “Harry Shubin, M.D. Statesman in Healthcare Administration Award,” presented by the American Academy of Medical Administrators. Indeed, Shubin had a long career in hospital administration. He was graduated from Temple School of Medicine in 1937, and went into family practice, at the age of 22. Later, he specialized in the treatment of tuberculosis and pulmonary disease.[2] Over his long career, he was a patron of the arts and of other charities in Philadelphia.

In 1955, Dr Shubin became the president of the American Academy of Tuberculosis Physicians.[3] In 1958, Shubin was elected head of staff at Pennsylvania General Hospital.[4] He later became the medical director of the Northern Division of Philadelphia General Hospital.

In 1962, along with 18 other physicians, Shubin purchased a 104-bed hospital, known as the Broad Street Hospital, at 739 South Broad Street, for which he would become medical director.[5] When the Jefferson Medical College sold its Barton Memorial Hospital for “diseases of the chest,” including silicosis and coal workers’ pneumoconiosis, at Broad and Fitzwater Streets, the South Broad Street Medical Center, Inc., bought it.  Shubin was the medical director.[6]

Shubin’s career as a medical director suffered in the ensuing decades.[7] In 1970, after a hearing, Dr. Shubin was disqualified by the U.S. Food & Drug Administration from receiving investigational products.[8] And then in 1981, his Center City Hospital, at 1829 Pine Street, closed, under pressure from both Blue Cross and the federal Health Systems Agency.[9]

Perhaps those setbacks explain Dr. Shubin’s foray into the lucrative world of expert witnessing in the asbestos litigation. Shubin started turning up as an expert witness for plaintiffs in hundreds of cases, in 1985. Dr. Peter Theodos, a prominent Philadelphia pulmonary physician had been designated to testify in these cases, but he died while the cases languished due to the huge backlog of asbestos cases in Philadelphia.

Shubin’s qualifications to replace Theodos were thin, Aside from an insignificant paper in a Pennsylvania Medicine,[10] Shubin had not written anything on asbestos or asbestos-related disease. Shubin was, however, a media hound, and in 1985, he was turning up at union halls and town hall meetings across Pennsylvania.[11]

Despite his lack of significant experience and expertise in asbestos-related disease, Shubin could put on a great show for uncritical Philadelphia juries. He was charming and persuasive. His years of public speaking on behalf of his beleaguered hospitals gave him confidence and skills of evasion in the witness box. When confronted with statements from Selikoff’s book or articles, Shubin would chuckle, smile knowingly, and say that he taught Selikoff everything about asbestos. His demeanor was avuncular and cherubic, which made cross-examination even more difficult.

Initially, Shubin testified that he was a B-reader, but after the defense verified his absence from the NIOSH list of certified B-readers, he “modified” his next trial’s testimony to state that he had started, but had not finished, the examination because of an eye problem.

After inquiring at NIOSH and learning that Shubin had finished the examination, defense counsel confronted Shubin yet again, only to have his tale embellished by a claim that he had withdrawn from the examination after finishing because of the eye problem, and wrote to NIOSH to ask that his examination not be evaluated.

In 1986, the leading asbestos plaintiffs’ firm was pushing one of its many cases to trial, with a Shubin report to support its claims.[12] Although the defense expert witnesses had given this plaintiff a clean bill of health, we had sufficient concerned about Shubin’s testimonial skills, that I decided to document Shubin’s perjury on the subject of his B-Reader status.

In 1986, the records’ custodian of B-Reader test results for NIOSH was Mitizie Martin, in Morgantown, West Virginia. After a good deal of procedural wrangling, I was able to obtain a court order that required plaintiffs’ counsel’s appearance for a deposition of Ms. Martin, in Morgantown. I noticed her deposition in all Philadelphia asbestos cases and gave all plaintiffs’ firms notice of the event. And so, in the first week of September, 1986, plaintiffs’ counsel, John DiDonato, and I were on board a small airplane for a bumpy ride to Morgantown, for Ms. Martin’s deposition.[13]

Martin was a wonderful witness. In 1986, she was Chief of the X-ray Receiving Center Section, Division of X-Ray Disease Studies, for NIOSH. She had been with NIOSH or its predecessor for 20 years.[14] Martin explained NIOSH’s role in teaching the A-Reader course, and in administering the B-Reader examination, along with the American College of Radiology, and its record retention policies.

Martin described the B-reader examination, which at the time required a showing of proficiency in interpreting 125 chest films for the presence and absence of various pneumoconiosis, according to the ILO scale.[15]

Finally, and most important, Martin authenticated the Shubin file, and laid a foundation for its admissibility at all future asbestos trials. Shubin had sought to become a B-Reader by taking the required test, in March 1982, in Orlando, Florida.[16] He completed but failed that examination in 1982, after which he wrote to Ms. Martin, to express his desire to take the test again. He made no mention of an eye problem; nor did he request that the 1982 results be disregarded. Martin wrote back to explain that he would have to wait a year before taking the examination again.[17]

Shubin waited three years, but he eventually signed up for, and took, the B-Reader examination a second time, in March 1985, on Kiawah Island, South Carolina. This second attempt resulted in a second failure, and a notification to Shubin that he had received a “failing grade, deficient in most categories.”[18] Shubin had thus taken the B-Reader examination twice, and failed both times. He had never abandoned the test; nor had he written to NIOSH to request a withdrawal from the examination, or to notify the agency of an eye-sight problem.[19]

My then colleague, Terri Keeley, was set to try the next-schedule case in which Dr. Shubin was supposed to have testified, in September 1986. Unsurprisingly, the case resolved. As soon as I received the transcript, I provided a copy gratis to every asbestos plaintiffs’ firm in Philadelphia. The result was that we never saw Dr. Shubin in an asbestos case again. Occasionally, we would receive a Dr. Shubin report, but a quick reminder of the procedural history behind Ms. Mitzie Martin’s deposition testimony sealed his effectual exclusion.

Remarkably, despite the notoriety he had gained in the Philadelphia asbestos litigation, Shubin showed up in the high-profile Paoli Railroad PCB case, as an expert witness on causation.[20] In the Paoli case, Shubin gave rather unscientific testimony that conflated general and specific causation, and assumed that PCBs caused individual plaintiffs’ disease because PCBs can cause disease.[21] As far I can determine, he was never confronted with his perjuries from the Philadelphia asbestos cases.

————————————————————————————————————————

[1]  Downing v. Johns-Manville Corp., Philadelphia Cty. Ct. C.P. 1981- 11- 3762, Order sur Motion to Compel Dr. Sokolowski to answer interrogatories and produce documents related to his failure of the B-Reader examination (Mar. 31, 1988).

[2]  “Harry Shubin Obituary,” Phila. Inq. at 25 (Mar. 7, 1997) (Dr. Shbuin died March 2, 1997).

[3]  “News from the Field,” 45 Am. J. Pub. Health 1399 (1955).

[4]  “Pennsylvania General Hospital,” Phila. Inq. at 29 (Mar. 25, 1958).

[5]  “Doctor-Owned Hospital Opens in South Philadelphia,” Phila. Daily News at p.19 (Feb. 5, 1962).

[6]  “Medical Center Sells Building,” Phila. Daily News at 57 (May 5, 1961).

[7]  Frank Dougherty, “11 Hospitals Cut from Blue Cross,” Phila. Daily News at p.3 (Nov. 14, 1972) (Broad Street Hospital cut).

[8]  Office of Regulatory Affairs Compliance References: Bioresearch Monitoring (Mar. 16, 1970).

[9]  Phila. Inq. at 5 (Mar. 18, 1981) (Shubin, medical director).

[10]  Harry Shubin, “Asbestosis: inhalation disease of the lungs,” 88 Pa. Med. 54, 56, 58 (1985).

[11]  See, e.g., “Pat Purcell, Angry Man,” Pottsville Republican (Pottsville, PA) at p.1 (Mar. 14, 1987); Frank Scholz, “Help Coming for Asbestos Victims Living Here,” The Times-Tribune (Scranton, PA Sept. 15, 1985).

[12]  Ove Nyman v. Johns-Mansville Corp., Phila. Cty. Ct. C.P. (April Term, 1981). Years later, I met Mr. Nyman at my sister-in-law’s wedding, where he and his wife were dancing vigorously.

[13]  Deposition of Mitzie Martin, in Ove Nyman v. Johns-Mansville Corp., Phila. Cty. Ct. C.P. (April Term, 1981), taken on Sept. 5, 1986.

[14]  Id. at 3.

[15]  Id. at 7.

[16]  Id. at 12-13.

[17]  Id. at 14.

[18]  Id. at 14-15.

[19]  Id. at 16-19.

[20] In re Paoli R.R. Yard PCB Litig., 706 F. Supp. 358, 364-65 (E.D. Pa. 1988), rev’d, 916 F.2d 829, 840 (3d Cir. 1990), cert. denied, 111 S. Ct. 1584 (1991).

[21]  Susan R. Poulter, “Science and Toxic Torts: Is There a Rational Solution to the Problem of Causation?” 7 High Technology L.J. 189, 238 (1993).

Posted in Asbestos, Expert Witness Hall of Shame, Expert Witnesses | No Comments »

April Fool – Zambelli-Weiner Must Disclose

April 2nd, 2020

Back in the summer of 2019, Judge Saylor, the MDL judge presiding over the Zofran birth defect cases, ordered epidemiologist, Dr. Zambelli-Weiner to produce documents relating to an epidemiologic study of Zofran,[1] as well as her claimed confidential consulting relationship with plaintiffs’ counsel.[2]

This previous round of motion practice and discovery established that Zambelli-Weiner was a paid consultant in advance of litigation, that her Zofran study was funded by plaintiffs’ counsel, and that she presented at a Las Vegas conference, for plaintiffs’ counsel only, on [sic] how to make mass torts perfect. Furthermore, she had made false statements to the court about her activities.[3]

Zambelli-Weiner ultimately responded to the discovery requests but she and plaintiffs’ counsel withheld several documents as confidential, pursuant to the MDL’s procedure for protective orders. Yesterday, April 1, 2020, Judge Saylor entered granted GlaxoSmithKline’s motion to de-designate four documents that plaintiffs claimed to be confidential.[4]

Zambelli-Weiner sought to resist GSK’s motion to compel disclosure of the documents on a claim that GSK was seeking the documents to advance its own litigation strategy. Judge Saylor acknowledged that Zambelli-Weiner’s psycho-analysis might be correct, but that GSK’s motive was not the critical issue. According to Judge Saylor, the proper inquiry was whether the claim of confidentiality was proper in the first place, and whether removing the cloak of secrecy was appropriate under the facts and circumstances of the case. Indeed, the court found “persuasive public-interest reasons” to support disclosure, including providing the FDA and the EMA a complete, unvarnished view of Zambelli-Weiner’s research.[5] Of course, the plaintiffs’ counsel, in close concert with Zambelli-Weiner, had created GSK’s need for the documents.

This discovery battle has no doubt been fought because plaintiffs and their testifying expert witnesses rely heavily upon the Zambelli-Weiner study to support their claim that Zofran causes birth defects. The present issue is whether four of the documents produced by Dr. Zambelli-Weiner pursuant to subpoena should continue to enjoy confidential status under the court’s protective order. GSK argued that the documents were never properly designated as confidential, and alternatively, the court should de-designate the documents because, among other things, the documents would disclose information important to medical researchers and regulators.

Judge Saylor’s Order considered GSK’s objections to plaintiffs’ and Zambelli-Weiner’s withholding four documents:

(1) Zambelli-Weiner’s Zofran study protocol;

(2) Undisclosed, hidden analyses that compared birth defects rates for children born to mothers who used Zofran with the rates seen with the use of other anti-emetic medications;

(3) An earlier draft Zambelli-Weiner’s Zofran study, which she had prepared to submit to the New England Journal of Medicine; and

(4) Zambelli-Weiner’s advocacy document, a “Causation Briefing Document,” which she prepared for plaintiffs’ lawyers.

Judge Saylor noted that none of the withheld documents would typically be viewed as confidential. None contained “sensitive personal, financial, or medical information.”[6]  The court dismissed Zambelli-Weiner’s contention that the documents all contained “business and proprietary information,” as conclusory and meritless. Neither she nor plaintiffs’ counsel explained how the requested documents implicated proprietary information when Zambelli-Weiner’s only business at issue is to assist in making lawsuits. The court observed that she is not “engaged in the business of conducting research to develop a pharmaceutical drug or other proprietary medical product or device,” and is related solely to her paid consultancy to plaintiffs’ lawyers. Neither she nor the plaintiffs’ lawyers showed how public disclosure would hurt her proprietary or business interests. Of course, if Zambelli-Weiner had been dishonest in carrying out the Zofran study, as reflected in study deviations from its protocol, her professional credibility and her business of conducting such studies might well suffer. Zambelli-Weiner, however, was not prepared to affirm the antecedent of that hypothetical. In any event, the court found that whatever right Zambelli-Weiner might have enjoyed to avoid discovery evaporated with her previous dishonest representations to the MDL court.[7]

The Zofran Study Protocol

GSK sought production of the Zofran study protocol, which in theory contained the research plan for the Zofran study and the analyses the researchers intended to conduct. Zambelli-Weiner attempted to resist production on the specious theory that she had not published the protocol, but the court found this “non-publication” irrelevant to the claim of confidentiality. Most professional organizations, such as the International Society of Pharmacoepidemiology (“ISPE”), which ultimately published Zambelli-Weiner’s study, encourage the publication and sharing of study protocols.[8] Disclosure of protocols helps ensure the integrity of studies by allowing readers to assess whether the researchers have adhered to their study plan, or have engaged in ad hoc data dredging in search for a desired result.[9]

The Secret, Undisclosed Analyses

Perhaps even more egregious than withholding the study protocol was the refusal to disclose unpublished analyses comparing the rate of birth defects among children born to mothers who used Zofran with the birth defect rates of children with in utero exposure to other anti-emetic medications.  In ruling that Zambelli-Weiner must produce the unpublished analyses, the court expressed its skepticism over whether these analyses could ever have been confidential. Under ISPE guidelines, researchers must report findings that significantly affect public health, and the relative safety of Zofran is essential to its evaluation by regulators and prescribing physicians.

Not only was Zambelli-Weiner’s failure to include these analyses in her published article ethically problematic, but she apparently hid these analyses from the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, which specifically inquired of Zambelli-Weiner whether she had performed such analyses. As a result, the PRAC recommended a label change based upon Zambelli-Weiner’s failure to disclosure material information. Furthermore, the plaintiffs’ counsel represented they intended to oppose GSK’s citizen petition to the FDA, based upon the Zambelli-Weiner study. The apparently fraudulent non-disclosure of relevant analyses could not have been more fraught for public health significance. The MDL court found that the public health need trumped any (doubtful) claim to confidentiality.[10] Against the obvious public interest, Zambelli-Weiner offered no “compelling countervailing interest” in keeping her secret analyses confidential.

There were other aspects to the data-dredging rationale not discussed in the court’s order. Without seeing the secret analyses of other anti-emetics, readers were deprive of an important opportunity to assess actual and potential confounding in her study. Perhaps even more important, the statistical tools that Zambelli-Weiner used, including any measurements of p-values and confidence intervals, and any declarations of “statistical significance,” were rendered meaningless by her secret, undisclosed, multiple testing. As noted by the American Statistical Association (ASA) in its 2016 position statement, “4. Proper inference requires full reporting and transparency.”

The ASA explains that the proper inference from a p-value can be completely undermined by “multiple analyses” of study data, with selective reporting of sample statistics that have attractively low p-values, or cherry picking of suggestive study findings. The ASA points out that common practices of selective reporting compromises valid interpretation. Hence the correlative recommendation:

“Researchers should disclose the number of hypotheses explored during the study, all data collection decisions, all statistical analyses conducted and all p-values computed. Valid scientific conclusions based on p-values and related statistics cannot be drawn without at least knowing how many and which analyses were conducted, and how those analyses (including p-values) were selected for reporting.”[11]

The Draft Manuscript for the New England Journal of Medicine

The MDL court wasted little time and ink in dispatching Zambelli-Weiner’s claim of confidentiality for her draft New England Journal of Medicine manuscript. The court found that she failed to explain how any differences in content between this manuscript and the published version constituted “proprietary business information,” or how disclosure would cause her any actual prejudice.

Zambelli-Weiner’s Litigation Road Map

In a world where social justice warriors complain about organizations such as Exponent, for its litigation support of defense efforts, the revelation that Zambelli-Weiner was helping to quarterback the plaintiffs’ offense deserves greater recognition. Zambelli-Weiner’s litigation road map was clearly created to help Grant & Eisenhofer, P.A., the plaintiffs’ lawyers,, create a causation strategy (to which she would add her Zofran study). Such a document from a consulting expert witness is typically the sort of document that enjoys confidentiality and protection from litigation discovery. The MDL court, however, looked beyond Zambelli-Weiner’s role as a “consulting witness” to her involvement in designing and conducting research. The broader extent of her involvement in producing studies and communicating with regulators made her litigation “strategery” “almost certainly relevant to scientists and regulatory authorities” charged with evaluating her study.”[12]

Despite Zambelli-Weiner’s protestations that she had made a disclosure of conflict of interest, the MDL court found her disclosure anemic and the public interest in knowing the full extent of her involvement in advising plaintiffs’ counsel, long before the study was conducted, great.[13]

The legal media has been uncommonly quiet about the rulings on April Zambelli-Weiner, in the Zofran litigation. From the Union of Concerned Scientists, and other industry scolds such as David Egilman, David Michaels, and Carl Cranor – crickets. Meanwhile, while the appeal over the admissibility of her testimony is pending before the Pennsylvania Supreme Court,[14] Zambelli-Weiner continues to create an unenviable record in Zofran, Accutane,[15] Mirena,[16] and other litigations.

[1]  April Zambelli‐Weiner, Christina Via, Matt Yuen, Daniel Weiner, and Russell S. Kirby, “First Trimester Pregnancy Exposure to Ondansetron and Risk of Structural Birth Defects,” 83 Reproductive Toxicology 14 (2019).

[2]  See In re Zofran (Ondansetron) Prod. Liab. Litig., 392 F. Supp. 3d 179, 182-84 (D. Mass. 2019) (MDL 2657) [cited as In re Zofran].

[3]  “Litigation Science – In re Zambelli-Weiner” (April 8, 2019); “Mass Torts Made Less Bad – The Zambelli-Weiner Affair in the Zofran MDL” (July 30, 2019). See also Nate Raymond, “GSK accuses Zofran plaintiffs’ law firms of funding academic study,” Reuters (Mar. 5, 2019).

[4]  In re Zofran Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, Order on Defendant’s Motion to De-Designate Certain Documents as Confidential Under the Protective Order (D.Mass. Apr. 1, 2020) [Order].

[5]  Order at n.3

[6]  Order at 3.

[7]  See In re Zofran, 392 F. Supp. 3d at 186.

[8]  Order at 4. See also Xavier Kurz, Susana Perez-Gutthann, the ENCePP Steering Group, “Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP),” 27 Pharmacoepidemiology & Drug Safety 245 (2018).

[9]  Order at note 2 (citing Charles J. Walsh & Marc S. Klein, “From Dog Food to Prescription Drug Advertising: Litigating False Scientific Establishment Claims Under the Lanham Act,” 22 Seton Hall L. Rev. 389, 431 (1992) (noting that adherence to study protocol “is essential to avoid ‘data dredging’—looking through results without a predetermined plan until one finds data to support a claim”).

[10]  Order at 5, citing Anderson v. Cryovac, Inc., 805 F.2d 1, 8 (1st Cir. 1986) (describing public-health concerns as “compelling justification” for requiring disclosing of confidential information).

[11]  Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” 70 The American Statistician 129 (2016)

See also “The American Statistical Association’s Statement on and of Significance” (March 17, 2016).“Courts Can and Must Acknowledge Multiple Comparisons in Statistical Analyses” (Oct. 14, 2014).

[12]  Order at 6.

[13]  Cf. Elizabeth J. Cabraser, Fabrice Vincent & Alexandra Foote, “Ethics and Admissibility: Failure to Disclose Conflicts of Interest in and/or Funding of Scientific Studies and/or Data May Warrant Evidentiary Exclusions,” Mealey’s Emerging Drugs Reporter (Dec. 2002) (arguing that failure to disclose conflicts of interest and study funding should result in evidentiary exclusions).

[14]  Walsh v. BASF Corp., GD #10-018588 (Oct. 5, 2016, Pa. Ct. C.P. Allegheny Cty., Pa.) (finding that Zambelli-Weiner’s and Nachman Brautbar’s opinions that pesticides generally cause acute myelogenous leukemia, that even the smallest exposure to benzene increases the risk of leukemia offended generally accepted scientific methodology), rev’d, 2018 Pa. Super. 174, 191 A.3d 838, 842-43 (Pa. Super. 2018), appeal granted, 203 A.3d 976 (Pa. 2019).

[15]  In re Accutane Litig., No. A-4952-16T1, (Jan. 17, 2020 N.J. App. Div.) (affirming exclusion of Zambelli-Weiner as an expert witness).

[16]  In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396 (S.D.N.Y. 2016) (excluding Zambelli-Weiner in part).

Posted in Conflicts of Interest, Data Sharing, Expert Witness Discovery, Expert Witness Hall of Shame, Expert Witnesses, Scientific Misconduct, Scientific Publishing, statistical evidence, Trial Procedure, Underlying Data | Comments Off on April Fool – Zambelli-Weiner Must Disclose

Science Journalism – UnDark Noir

February 23rd, 2020

Critics of the National Association of Scholars’ conference on Fixing Science pointed readers to an article in Undark, an on-line popular science site for lay audiences, and they touted the site for its science journalism. My review of the particular article left me unimpressed and suspicious of Undark’s darker side. When I saw that the site featured an article on the history of the Supreme Court’s Daubert decision, I decided to give the site another try. For one thing, I am sympathetic to the task science journalists take on: it is important and difficult. In many ways, lawyers must commit to perform the same task. Sadly, most journalists and lawyers, with some notable exceptions, lack the scientific acumen and English communication skills to meet the needs of this task.

The Undark article that caught my attention was a history of the Daubert decision and the Bendectin litigation that gave rise to the Supreme Court case.[1] The author, Peter Andrey Smith, is a freelance reporter, who often covers science issues. In his Undark piece, Smith covered some of the oft-told history of the Daubert case, which has been told before, better and in more detail in many legal sources. Smith gets some credit for giving the correct pronunciation of the plaintiff’s name – “DAW-burt,” and for recounting how both sides declared victory after the Supreme Court’s ruling. The explanation Smith gives of the opinion by Associate Justice Harry Blackmun is reasonably accurate, and he correctly notes that a partial dissenting opinion by Chief Justice Rehnquist complained that the majority’s decision would have trial judges become “amateur scientists.” Nowhere in the article will you find, however, the counter to the dissent: an honest assessment of the institutional and individual competence of juries to decide complex scientific issues.

The author’s biases eventually, however, become obvious. He recounts his interviews with Jason Daubert and his mother, Joyce Daubert. He earnestly reports how Joyce Daubert remembered having taken Bendectin during her pregnancy with Jason, and in the moment of that recall, “she felt she’d finally identified the teratogen that harmed Jason.” Really? Is that how teratogens are identified? Might it have been useful and relevant for a scientific journalist to explain that there are four million live births every year in the United States and that 3% of children born each year have major congenital malformations? And that most malformations have no known cause? Smith ingenuously relays that Jason Daubert had genetic testing, but omits that genetic testing in the early 1990s was fairly primitive and limited. In any event, how were any expert witnesses supposed to rule out base-line risk of birth defects, especially given weak to non-existent epidemiologic support for the Daubert’s claims? Smith does answer these questions; he does not even acknowledge the questions.

Smith later quotes Joyce Daubert as describing the litigation she signed up for as “the hill I’ll die on. You only go to war when you think you can win.” Without comment or analysis, Smith gives Joyce Daubert an opportunity to rant against the “injustice” of how her lawsuit turned out. Smith tells us that the Dauberts found the “legal system remains profoundly disillusioning.” Joyce Daubert told Smith that “it makes me feel stupid that I was so naïve to think that, after we’d invested so much in the case, that we would get justice.”  When called for jury duty, she introduces herself as

“I’m Daubert of Daubert versus Merrell Dow … ; I don’t want to sit on this jury and pretend that I can pass judgment on somebody when there is no justice. Please allow me to be excused.”

But didn’t she really get all the justice she deserved? Given her zealotry, doesn’t she deserve to have her name on the decision that serves to rein in expert witnesses who outrun their scientific headlights? Smith is coy and does not say, but in presenting Mrs. Daubert’s rant, without presenting the other side, he is using his journalistic tools in a fairly blatant attempt to mislead. At this point, I begin to get the feeling that Smith is preaching to a like-minded choir over there at Undark.

The reader is not treated to any interviews with anyone from the company that made Bendectin, any of its scientists, or any of the scientists who published actual studies on whether Bendectin was associated with the particular birth defects Jason Daubert had, or for that matter, with any birth defects at all. The plaintiffs’ expert witnesses quoted and cited never published anything at all on the subject. The readers are left to their imagination about how the people who developed Bendectin felt about the litigation strategies and tactics of the lawsuit industry.

The journalistic ruse is continued with Smith’s treatment of the other actors in the Daubert passion play. Smith describes the Bendectin plaintiffs’ lawyer Barry Nace in hagiographic terms, but omits his bar disciplinary proceedings.[2] Smith tells us that Nace had an impressive background in chemistry, and quotes him in an interview in which he described the evidentiary rules on scientific witness testimony as “scientific evidence crap.”

Smith never describes the Daubert’s actual affirmative evidence in any detail, which one might expect in a sophisticated journalistic outlet. Instead, he described some of their expert witnesses, Shanna Swan, a reproductive epidemiologist, and Alan K. Done, “a former pediatrician from Wayne State University.” Smith is secretive about why Done was done in at Wayne State; and we learn nothing about the serious accusations of perjury on credentials by Done. Instead, Smith regales us with Done’s tsumish theory, which takes inconclusive bits of evidence, throws them together, and then declares causation that somehow eludes the rest of the scientific establishment.

Smith tells us that Swan was a rebuttal witness, who gave an opinion that the data did not rule out “the possibility Bendectin caused defects.” Legally and scientifically, Smith is derelict in failing to explain that the burden was on the party claiming causation, and that Swan’s efforts to manufacture doubt were beside the point. Merrell Dow did not have to rule out any possibility of causation; the plaintiffs had to establish causation. Nor does Smith delve into how Swan sought to reprise her performance in the silicone gel breast implant litigation, only to be booted by several judges as an expert witness. And then for a convincer, Smith sympathetically repeats plaintiffs’ lawyer Barry Nace’s hyperbolic claim that Bendectin manufacturer, Merrell Dow had been “financing scientific articles to get their way,” adding by way of emphasis, in his own voice:

“In some ways, here was the fake news of its time: If you lacked any compelling scientific support for your case, one way to undermine the credibility of your opponents was by calling their evidence ‘junk science’.”

Against Nace’s scatalogical Jackson Pollack approach, Smith is silent about another plaintiffs’ expert witness, William McBride, who was found guilty of scientific fraud.[3] Smith reports interviews of several well-known, well-respected evidence scholars. He dutifully report Professor Edward Cheng’s view that “the courts were right to dismiss the [Bendectin] plaintiffs’ claims.” Smith quotes Professor D. Michael Risinger that claims from both sides in Bendectin cases were exaggerated, and that the 1970s and 1980s saw an “unbridled expansion of self-anointed experts,” with “causation in toxic torts had been allowed to become extremely lax.” So a critical reader might wonder why someone like Professor Cheng, who has a doctorate in statistics, a law degree from Harvard, and teaches at Vanderbilt Law School, would vindicate the manufacturers’ position in the Bendectin litigation. Smith never attempts to reconcile his interviews of the law professors with the emotive comments of Barry Nace and Joyce Daubert.

Smith acknowledges that a reformulated version of Bendectin, known as  Diclegis, was approved by the Food and Drug Administration in the United States, in 2013, for treatment of  nausea and vomiting during pregnancy. Smith tells us that Joyce is not convinced the drug should be back on the market,” but really why would any reasonable person care about her view of the matter? The challenge by Nav Persaud, a Toronto physician, is cited, but Persaud’s challenge is to the claim of efficacy, not to the safety of the medication. Smith tells us that Jason Daubert “briefly mulled reopening his case when Diclegis, the updated version of Bendectin, was re-approved.” But how would the approval of Diclegis, on the strength of a full new drug application, somehow support his claim anew? And how would he “reopen” a claim that had been fully litigated in the 1990s, and well past any statute of limitations?

Is this straight reporting? I think not. It is manipulative and misleading.

Smith notes, without attribution, that some scholars condemn litigation, such as the cases involving Bendectin, as an illegitimate form of regulation of medications. In opposition, he appears to rely upon Elizabeth Chamblee Burch, a professor at the University of Georgia School of Law for the view that because the initial pivotal clinical trials for regulatory approvals take place in limited populations, litigation “serves as a stopgap for identifying rare adverse outcomes that could crop up when several hundreds of millions of people are exposed to those products over longer periods of time.” The problem with this view is that Smith ignores the whole process of pharmacovigilance, post-registration trials, and pharmaco-epidemiologic studies conducted after the licensing of a new medication. The suggested necessity of reliance upon the litigation system as an adjunct to regulatory approval is at best misplaced and tenuous.

Smith correctly explains that the Daubert standard is still resisted in criminal cases, where it could much improve the gatekeeping of forensic expert witness opinion. But while the author gets his knickers in a knot over wrongful convictions, he seems quite indifferent to wrongful judgments in civil action.

Perhaps the one positive aspect of this journalistic account of the Daubert case was that Jason Daubert, unlike his mother, was open minded about his role in transforming the law of scientific evidence. According to Smith, Jason Daubert did not see the case as having “not ruined his life.” Indeed, Jason seemed to approve the basic principle of the Daubert case, and the subsequent legislation that refined the admissibility standard: “Good science should be all that gets into the courts.”

[1] Peter Andrey Smith, “Where Science Enters the Courtroom, the Daubert Name Looms Large: Decades ago, two parents sued a drug company over their newborn’s deformity – and changed courtroom science forever,” Undark (Feb. 17, 2020).

[2]  Lawyer Disciplinary Board v. Nace, 753 S.E.2d 618, 621–22 (W. Va.) (per curiam), cert. denied, 134 S. Ct. 474 (2013).

[3] Neil Genzlinger, “William McBride, Who Warned About Thalidomide, Dies at 91,” N.Y. Times (July 15, 2018); Leigh Dayton, “Thalidomide hero found guilty of scientific fraud,” New Scientist (Feb. 27, 1993); G.F. Humphrey, “Scientific fraud: the McBride case,” 32 Med. Sci. Law 199 (1992); Andrew Skolnick, “Key Witness Against Morning Sickness Drug Faces Scientific Fraud Charges,” 263 J. Am. Med. Ass’n 1468 (1990).

Posted in Causation, Evidence, Expert Witness Hall of Shame, Expert Witnesses, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Science Journalism – UnDark Noir

The Shmeta-Analysis in Paoli

July 11th, 2019

In the Paoli Railroad yard litigation, plaintiffs claimed injuries and increased risk of future cancers from environmental exposure to polychlorinated biphenyls (PCBs). This massive litigation showed up before federal district judge Hon. Robert F. Kelly,[1] in the Eastern District of Pennsylvania, who may well have been the first judge to grapple with a litigation attempt to use meta-analysis to show a causal association.

One of the plaintiffs’ expert witnesses was the late William J. Nicholson, who was a professor at Mt. Sinai School of Medicine, and a colleague of Irving Selikoff. Nicholson was trained in physics, and had no professional training in epidemiology. Nonetheless, Nicholson was Selikoff’s go-to colleague for performing epidemiologic studies. After Selikoff withdrew from active testifying for plaintiffs in tort litigation, Nicholson was one of his colleagues who jumped into the fray as a surrogate advocate for Selikoff.[2]

For his opinion that PCBs were causally associated with liver cancer in humans,[3] Nicholson relied upon a report he wrote for the Ontario Ministry of Labor. [cited here as “Report”].[4] Nicholson described his report as a “study of the data of all the PCB worker epidemiological studies that had been published,” from which he concluded that there was “substantial evidence for a causal association between excess risk of death from cancer of the liver, biliary tract, and gall bladder and exposure to PCBs.”[5]

The defense challenged the admissibility of Nicholson’s meta-analysis, on several grounds. The trial court decided the challenge based upon the Downing case, which was the law in the Third Circuit, before the Supreme Court decided Daubert.[6] The Downing case allowed some opportunity for consideration of reliability and validity concerns; there is, however, disappointingly little discussion of any actual validity concerns in the courts’ opinions.

The defense challenge to Nicholson’s proffered testimony on liver cancer turned on its characterization of meta-analysis as a “novel” technique, which is generally unreliable, and its claim that Nicholson’s meta-analysis in particular was unreliable. None of the individual studies that contributed data showed any “connection” between PCBs and liver cancer; nor did any individual study conclude that there was a causal association.

Of course, the appropriate response to this situation, with no one study finding a statistically significant association, or concluding that there was a causal association, should have been “so what?” One of the reasons to do a meta-analysis is that no available study was sufficiently large to find a statistically significant association, if one were there. As for drawing conclusions of causal associations, it is not the role or place of an individual study to synthesize all the available evidence into a principled conclusion of causation.

In any event, the trial court concluded that the proffered novel technique lacked sufficient reliability, that the meta-analysis would “overwhelm, confuse, or mislead the jury,” and that the proffered meta-analysis on liver cancer was not sufficiently relevant to the facts of the case (in which no plaintiff had developed, or had died of, liver cancer). The trial court noted that the Report had not been peer-reviewed, and that it had not been accepted or relied upon by the Ontario government for any finding or policy decision. The trial court also expressed its concern that the proffered testimony along the lines of the Report would possibly confuse the jury because it appeared to be “scientific” and because Nicholson appeared to be qualified.

The Appeal

The Court of Appeals for the Third Circuit, in an opinion by Judge Becker, reversed Judge Kelly’s exclusion of the Nicholson Report, in an opinion that is still sometimes cited, even though Downing is no longer good law in the Circuit or anywhere else.[7] The Court was ultimately not persuaded that the trial court had handled the exclusion of Nicholson’s Report and its meta-analysis correctly, and it remanded the case for a do-over analysis.

Judge Becker described Nicholson’s Report as a “meta-analysis,” which pooled or “combined the results of numerous epidemiologic surveys in order to achieve a larger sample size, adjusted the results for differences in testing techniques, and drew his own scientific conclusions.”[8] Through this method, Nicholson claimed to have shown that “exposure to PCBs can cause liver, gall bladder and biliary tract disorders … even though none of the individual surveys supports such a conclusion when considered in isolation.”[9]

Validity

The appellate court gave no weight to the possibility that a meta-analysis would confuse a jury, or that its “scientific nature” or Nicholson’s credentials would lead a jury to give it more weight than it deserved.[10] The Court of Appeals conceded, however, that exclusion would have been appropriate if the methodology used itself was invalid. The appellate opinion further acknowledged that the defense had offered opposition to Nicholson’s Report in which it documented his failure to include data that were inconsistent with his conclusions, and that “Nicholson had produced a scientifically invalid study.”[11]

Judge Becker’s opinion for a panel of the Third Circuit provided no details about the cherry picking. The opinion never analyzed why this charge of cherry-picking and manipulation of the dataset did not invalidate the meta-analytic method generally, or Nicholson’s method as applied. The opinion gave no suggestion that this counter-affidavit was ever answered by the plaintiffs.

Generally, Judge Becker’s opinion dodged engagement with the specific threats to validity in Nicholson’s Report, and took refuge in the indisputable fact that hundreds of meta-analyses were published annually, and that the defense expert witnesses did not question the general reliability of meta-analysis.[12] These facts undermined the defense claim that meta-analysis was novel.[13] The reality, however, was that meta-analysis was in its infancy in bio-medical research.

When it came to the specific meta-analysis at issue, the court did not discuss or analyze a single pertinent detail of the Report. Despite its lack of engagement with the specifics of the Report’s meta-analysis, the court astutely observed that prevalent errors and flaws do not mean that a particular meta-analysis is “necessarily in error.”[14] Of course, without bothering to look, the court would not know whether the proffered meta-analysis was “actually in error.”

The appellate court would have given Nicholson’s Report a “pass” if it was an application of an accepted methodology. The defense’s remedy under this condition would be to cross-examine the opinion in front of a jury. If, on the other hand, the Nicholson had altered an accepted methodology to skew its results, then the court’s gatekeeping responsibility under Downing would be invoked.

The appellate court went on to fault the trial court for failing to make sufficiently explicit findings as to whether the questioned meta-analysis was unreliable. From its perspective, the Court of Appeals saw the trial court as resolving the reliability issue upon the greater credibility of defense expert witnesses in branding the disputed meta-analysis as unreliability. Credibility determinations are for the jury, but the court left room for a challenge on reliability itself:[15]

“Assuming that Dr. Nicholson’s meta-analysis is the proper subject of Downing scrutiny, the district court’s decision is wanting, because it did not make explicit enough findings on the reliability of Dr. Nicholson’s meta-analysis to satisfy Downing. We decline to define the exact level at which a district court can exclude a technique as sufficiently unreliable. Reliability indicia vary so much from case to case that any attempt to define such a level would most likely be pointless. Downing itself lays down a flexible rule. What is not flexible under Downing is the requirement that there be a developed record and specific findings on reliability issues. Those are absent here. Thus, even if it may be possible to exclude Dr. Nicholson’s testimony under Downing, as an unreliable, skewed meta-analysis, we cannot make such a determination on the record as it now stands. Not only was there no hearing, in limine or otherwise, at which the bases for the opinions of the contesting experts could be evaluated, but the experts were also not even deposed. All of the expert evidence was based on affidavits.”

Peer Review

Understandably, the defense attacked Nicholson’s Report as not having been peer reviewed. Without any scrutiny of the scientific bona fides of the workers’ compensation agency, the appellate court acquiesced in Nicholson’s self-serving characterization of his Report as having been reviewed by “cooperating researchers” and the Panel of the Ontario Workers’ Compensation agency. Another partisan expert witness characterized Nicholson’s Report as a “balanced assessment,” and this seemed to appease the Third Circuit, which was wary of requiring peer review in the first place.[16]

Relevancy Prong

The defense had argued that Nicholson’s Report was irrelevant because no individual plaintiff claimed liver cancer.[17] The trial court largely accepted this argument, but the appellate court disagreed because of conclusory language in Nicholson’s affidavit, in which he asserted that “proof of an increased risk of liver cancer is probative of an increased risk of other forms of cancer.” The court seemed unfazed by the ipse dixit, asserted without any support. Indeed, Nicholson’s assertion was contradicted by his own Report, in which he reported that there were fewer cancers among PCB-exposed male capacitor manufacturing workers than expected,[18] and that the rate for all cancers for both men and women was lower than expected, with 132 observed and 139.40 expected.[19]

The trial court had also agreed with the defense’s suggestion that Nicholson’s report, and its conclusion of causality between PCB exposure and liver cancer, were irrelevant because the Report “could not be the basis for anyone to say with reasonable degree of scientific certainty that some particular person’s disease, not cancer of the liver, biliary tract or gall bladder, was caused by PCBs.”[20]

Analysis

It would likely have been lost on Judge Becker and his colleagues, but Nicholson presented SMRs (standardized mortality ratios) throughout his Report, and for the all cancers statistic, he gave an SMR of 95. What Nicholson clearly did in this, and in all other instances, was simply divide the observed number by the expected, and multiply by 100. This crude, simplistic calculation fails to present a standardized mortality ratio, which requires taking into account the age distribution of the exposed and the unexposed groups, and a weighting of the contribution of cases within each age stratum. Nicholson’s presentation of data was nothing short of false and misleading. And in case anyone remembers General Electric v. Joiner, Nicholson’s summary estimate of risk for lung cancer in men was below the expected rate.[21]

Nicholson’s Report was replete with many other methodological sins. He used a composite of three organs (liver, gall bladder, bile duct) without any biological rationale. His analysis combined male and female results, and still his analysis of the composite outcome was based upon only seven cases. Of those seven cases, some of the cases were not confirmed as primary liver cancer, and at least one case was confirmed as not being a primary liver cancer.[22]

Nicholson failed to standardize the analysis for the age distribution of the observed and expected cases, and he failed to present meaningful analysis of random or systematic error. When he did present p-values, he presented one-tailed values, and he made no corrections for his many comparisons from the same set of data.

Finally, and most egregiously, Nicholson’s meta-analysis was meta-analysis in name only. What he had done was simply to add “observed” and “expected” events across studies to arrive at totals, and to recalculate a bogus risk ratio, which he fraudulently called a standardized mortality ratio. Adding events across studies is not a valid meta-analysis; indeed, it is a well-known example of how to generate a Simpson’s Paradox, which can change the direction or magnitude of any association.[23]

Some may be tempted to criticize the defense for having focused its challenge on the “novelty” of Nicholson’s approach in Paoli. The problem of course was the invalidity of Nicholson’s work, but both the trial court’s exclusion of Nicholson, and the Court of Appeals’ reversal and remand of the exclusion decision, illustrate the problem in getting judges, even well-respected judges, to accept their responsibility to engage with questioned scientific evidence.

Even in Paoli, no amount of ketchup could conceal the unsavoriness of Nicholson’s scrapple analysis. When the Paoli case reached the Court Appeals again in 1994, Nicholson’s analysis was absent.[24] Apparently, the plaintiffs’ counsel had second thoughts about the whole matter. Today, under the revised Rule 702, there can be little doubt that Nicholson’s so-called meta-analysis should have been excluded.

[1]  Not to be confused with the Judge Kelly of the same district, who was unceremoniously disqualified after attending an ex parte conference with plaintiffs’ lawyers and expert witnesses, at the invitation of Dr. Irving Selikoff.

[2]  Pace Philip J. Landrigan & Myron A. Mehlman, “In Memoriam – William J. Nicholson,” 40 Am. J. Indus. Med. 231 (2001). Landrigan and Mehlman assert, without any support, that Nicholson was an epidemiologist. Their own description of his career, his undergraduate work at MIT, his doctorate in physics from the University of Washington, his employment at the Watson Laboratory, before becoming a staff member in Irving Selikoff’s department in 1969, all suggest that Nicholson brought little to no experience in epidemiology to his work on occupational and environmental exposure epidemiology.

[3]  In re Paoli RR Yard Litig., 706 F. Supp. 358, 372-73 (E.D. Pa. 1988).

[4]  William Nicholson, Report to the Workers’ Compensation Board on Occupational Exposure to PCBs and Various Cancers, for the Industrial Disease Standards Panel (ODP); IDSP Report No. 2 (Toronto, Ontario Dec. 1987).

[5]  Id. at 373.

[6]  United States v. Downing, 753 F.2d 1224 (3d Cir.1985)

[7]  In re Paoli RR Yard PCB Litig., 916 F.2d 829 (3d Cir. 1990), cert. denied sub nom. General Elec. Co. v. Knight, 111 S.Ct. 1584 (1991).

[8]  Id. at 845.

[9]  Id.

[10]  Id. at 841, 848.

[11]  Id. at 845.

[12]  Id. at 847-48.

[13]  See, e.g., Robert Rosenthal, Judgment studies: Design, analysis, and meta-analysis (1987); Richard J. Light & David B. Pillemer, Summing Up: the Science of Reviewing Research (1984); Thomas A. Louis, Harvey V. Fineberg & Frederick Mosteller, “Findings for Public Health from Meta-Analyses,” 6 Ann. Rev. Public Health 1 (1985); Kristan A. L’abbé, Allan S. Detsky & Keith O’Rourke, “Meta-analysis in clinical research,” 107 Ann. Intern. Med. 224 (1987).

[14]  Id. at 857.

[15]  Id. at 858/

[16]  Id. at 858.

[17]  Id. at 845.

[18]  Report, Table 16.

[19]  Report, Table 18.

[20]  In re Paoli, 916 F.2d at 847.

[21]  See General Electric v. Joiner, 522 U.S. 136 (1997); NAS, “How Have Important Rule 702 Holdings Held Up With Time?” (March 20, 2015).

[22]  Report, Table 22.

[23]  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).

[24]  In re Paoli RR Yard Litig., 35 F.3d 717 (3d Cir. 1994).

Posted in Causation, Expert Witness Hall of Shame, Medical monitoring, Meta-analysis, Rule 702, Scientific Evidence | Comments Off on The Shmeta-Analysis in Paoli

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