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Peer Review, Protocols, and QRPs

April 3rd, 2024

In Daubert, the Supreme Court decided a legal question about the proper interpretation of a statute, Rule 702, and then remanded the case to the Ninth Circuit of the Court of Appeals for further proceedings. The Court did, however, weigh in with dicta about some several considerations in admissibility decisions.  In particular, the Court identified four non-dispositive factors: whether the challenged opinion has been empirically tested, published and peer reviewed, and whether the underlying scientific technique or method supporting the opinion has an acceptable rate of error, and has gained general acceptance.[1]

The context in which peer review was discussed in Daubert is of some importance to our understanding its holding peer review out as a consideraton. One of the bases for the defense challenges to some of the plaintiffs’ expert witnesses’ opinions in Daubert was their reliance upon re-analyses of published studies to suggest that there was indeed an increased risk of birth defects if only the publication authors had used some other control group, or taken some other analytical approach. Re-analyses can be important, but these reanalyses of published Bendectin studies were post hoc, litigation driven, and obviously result oriented. The Court’s discussion of peer review reveals that it was not simply creating a box to be checked before a trial court could admit an expert witness’s opinions. Peer review was suggested as a consideration because:

“submission to the scrutiny of the scientific community is a component of “good science,” in part because it increases the likelihood that substantive flaws in methodology will be detected. The fact of publication (or lack thereof) in a peer reviewed journal thus will be a relevant, though not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which an opinion is premised.”[2]

Peer review, or the lack thereof, for the challenged expert witnesses’ re-analyses was called out because it raised suspicions of lack of validity. Nothing in Daubert, or in later decisions, or more importantly in Rule 702 itself, supports admitting expert witness testimony just because the witness relied upon peer-reviewed studies, especially when the studies are invalid or are based upon questionable research practices. The Court was careful to point out that peer-reviewed publication was “not a sine qua non of admissibility; it does not necessarily correlate with reliability, … .”[3] The Court thus showed that it was well aware that well-ground (and thus admissible) opinions may not have been previously published, and that the existence of peer review was simply a potential aid in answering the essential question, whether the proponent of a proffered opinion has shown “the scientific validity of a particular technique or methodology on which an opinion is premised.”[4]

Since 1993, much has changed in the world of bio-science publishing. The wild proliferation of journals, including predatory and “pay-to-play” journals, has disabused most observers that peer review provides evidence of validity of methods. Along with the exponential growth in publications has come an exponential growth in expressions of concern and out-right retractions of articles, as chronicled and detailed at Retraction Watch.[5] Some journals encourage authors to nominate the peer reviewers for their manuscripts; some journals let authors block some scientists as peer reviewers of their submitted manuscripts. If the Supreme Court were writing today, it might well note that peer review is often a feature of bad science, advanced by scientists who know that peer-reviewed publication is the price of admission to the advocacy arena.

Since the Supreme Court decided Daubert, the Federal Judicial Center and National Academies of Science have provided a Reference Manual for Scientific Evidence, now in its third edition, and with a fourth edition on the horizon, to assist judges and lawyers involved in the litigation of scientific issues. Professor Goodstein, in his chapter “How Science Works,” in the third edition, provides the most extensive discussion of peer review in the Manual, and emphasizes that peer review “works very poorly in catching cheating or fraud.”[6]  Goodstein invokes his own experience as a peer reviewer to note that “peer review referees and editors limit their assessment of submitted articles to such matters as style, plausibility, and defensibility; they do not duplicate experiments from scratch or plow through reams of computer-generated data in order to guarantee accuracy or veracity or certainty.”[7] Indeed, Goodstein’s essay in the Reference Manual characterizes the ability of peer review to warrant study validity as a “myth”:

“Myth: The institution of peer review assures that all published papers are sound and dependable.

Fact: Peer review generally will catch something that is completely out of step with majority thinking at the time, but it is practically useless for catching outright fraud, and it is not very good at dealing with truly novel ideas. … It certainly does not ensure that the work has been fully vetted in terms of the data analysis and the proper application of research methods.”[8]

Goodstein’s experience as a peer reviewer is hardly idiosyncratic. One standard text on the ethical conduct of research reports that peer review is often ineffective or incompetent, and that it may not even catch simple statistical or methodological errors.[9] According to the authors, Shamoo and Resnik:

“[p]eer review is not good at detecting data fabrication or falsification partly because reviewers usually do not have access to the material they would need to detect fraud, such as the original data, protocols, and standard operating procedures.”[10]

Indeed, without access to protocols, statistical analysis plans, and original data, peer review often cannot identify good faith or negligent deviations from the standard of scientific care. There is some evidence to support this negative assessment of peer review from testing of the counter-factual. Reviewers were able to detect questionable, selective reporting when they had access to the study authors’ research protocols.[11]

Study Protocol

The study protocol provides the scientific rationale for a study, clearly defines the research question, the data collection process, defines the key exposure and outcomes, and describes the methods to be applied, before commencing data collection.[12] The protocol also typically pre-specifies the statistical data analysis. The epidemiology chapter of the current edition of the Reference Manual for Scientific Evidence offers blandly only that epidemiologists attempt to minimize bias in observational studies with “data collection protocols.”[13] Epidemiologists and statisticians are much clearer in emphasizing the importance, indeed the necessity, of having a study protocol before commencing data collection. Back in 1988, John Bailar and Frederick Mosteller explained that it was critical in reporting statistical analyses to inform readers about how and when the authors devised the study design, and whether they set the design criteria out in writing before they began to collect data.[14]

The necessity of a study protocol is “self-evident,”[15] and essential to research integrity.[16] The International Society of Pharmacoepidemiology has issued Guidelines for “Good Pharmacoepidemiology Practices,”[17] which calls for every study to have a written protocol. Among the requirements set out in this set of guidelines are descriptions of the research method, study design, operational definitions of exposure and outcome variables, and projected study sample size. The Guidelines provide that a detailed statistical analysis plan may be specified after data collection begins, but before any analysis commences.

Expert witness opinions on health effects are built upon studies, and so it behooves legal counsel to identify the methodological strengths and weaknesses of key studies through questioning whether they have protocols, whether the protocols were methodologically appropriate, and whether the researchers faithfully followed their protocols and their statistical analysis plans. Determining the peer review status of a publication, on the other hand, will often not advance a challenge based upon improvident methodology.

In some instances, a published study will have sufficiently detailed descriptions of methods and data that readers, even lawyers, can evaluate their scientific validity or reliability (vel non). In some cases, however, readers will be no better off than the peer reviewers who were deprived of access to protocols, statistical analysis plans, and original data. When a particular study is crucial support for an adversary’s expert witness, a reasonable litigation goal may well be to obtain the protocol and statistical analysis plan, and if need be, the original underlying data. The decision to undertake such discovery is difficult. Discovery of non-party scientists can be expensive and protracted; it will almost certainly be contentious. When expert witnesses rely upon one or a few studies, which telegraph internal validity, this litigation strategy may provide the strongest evidence against the study’s being reasonably relied upon, or its providing “sufficient facts and data” to support an admissible expert witness opinion.

[1] Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 593-594 (1993).

[2] Id. at 594 (internal citations omitted) (emphasis added).

[3] Id.

[4] Id. at 593-94.

[5] Retraction Watch, at https://retractionwatch.com/.

[6] Reference Manual on Scientific Evidence at 37, 44-45 (3rd ed. 2011) [Manual].

[7] Id. at 44-45 n.11.

[8] Id. at 48 (emphasis added).

[9] Adil E. Shamoo and David B. Resnik, Responsible Conduct of Research 133 (4th ed. 2022).

[10] Id.

[11] An-Wen Chan, Asbjørn Hróbjartsson, Mette T. Haahr, Peter C. Gøtzsche, and David G. Altman, D. G. “Empirical evidence for selective reporting of outcomes in randomized trials: Comparison of protocols to published articles,” 291 J. Am. Med. Ass’n 2457 (2004).

[12] Wolfgang Ahrens & Iris Pigeot, eds., Handbook of Epidemiology 477 (2nd ed. 2014).

[13] Michael D. Green, D. Michal Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” in Reference Manual on Scientific Evidence 573 (3rd ed. 2011) 573 (“Study designs are developed before they begin gathering data.”).

[14] John Bailar & Frederick Mosteller, “Guidelines for Statistical Reporting in Articles for Medical Journals,” 108 Ann. Intern. Med. 2266, 268 (1988).

[15] Wolfgang Ahrens & Iris Pigeot, eds., Handbook of Epidemiology 477 (2nd ed. 2014).

[16] Sandra Alba, et al., “Bridging research integrity and global health epidemiology statement: guidelines for good epidemiological practice,” 5 BMJ Global Health e003236, at p.3 & passim (2020).

[17] See “The ISPE Guidelines for Good Pharmacoepidemiology Practices (GPP),” available at <https://www.pharmacoepi.org/resources/policies/guidelines-08027/>.

Posted in Data Sharing, Expert Witness Discovery, Rule 702, Rule 703, statistical evidence, Underlying Data | 12 Comments »

Doctor Moline – Why Can’t You Be True?

December 18th, 2022

Doctor Moline, why can’t you be true?

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

You done started doing the things you used to do.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

And then there were others, too.

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

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

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

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

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

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

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

[7] Complaint ¶15.

[8] Complaint ¶19.

[9] Moline at 11.

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

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

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

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

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

Posted in Expert Witness Discovery, Expert Witnesses, Rule 702, Scientific Evidence, Scientific Misconduct, Underlying Data | 31 Comments »

Expert Witness Reports Are Not Admissible

August 23rd, 2021

The tradition of antic proposals to change the law of evidence is old and venerable in the common law. In the early 19th century, Jeremy Bentham deviled the English bench and bar with sweeping proposals to place evidence law on a rationale foundation. Bentham’s contributions to his contributions to jurisprudence, like his utilitarianism, often ignored the realities of human experience and decision making. Although Bentham contributed little to the actual workings of courtroom law and procedure, he gave rise to a tradition of antic proposals that have long entertained law professors and philosophers.[1]

Bentham seemingly abhorred tradition, but his writings have given rise to a tradition of antic proposals in the law. Expert witness testimony was uncommon in the early 19th century, but today, hardly a case is tried without expert witnesses. We should not be surprised, therefore, by the rise of antic proposals for reforming the evidence law of expert witness opinion testimony.[2]

A key aspect of the Bentham tradition is ignore the actual experience and conduct of human affairs. And so now we have a proposal to shorten trials by foregoing direct examination of expert witnesses, and admitting the expert witnesses’ reports into evidence.[3] The argument contends that since the Rule 26 report requires disclosure of all the expert witnesses’ substantive opinions and all bases for their opinions, the witnesses’ viva voce testimony is merely a recital of the report. The argument proceeds that reports can be helpful in understanding complex issues and in moving trials along more efficiently.

As much as all lawyers want to promote “understanding,” and make trials more efficient, the argument fails on multiple levels. First, judges can read the expert witness reports, in bench or in jury trials, to help themselves prepare for trial, without admitting the reports into evidence. Second, the rules of evidence, which are binding upon trial judges in both bench and jury trials, require that the testimony be helpful, not the reports. Third, the argument ignores that for the last several years, the federal rules have allowed lawyers to draft reports to a large extent, without any discovery into whose phraseology appears in a final report.

Even before the federal rules created an immunity to discovery into who drafted specific language of an expert report, it was not uncommon to find that there at least some parts of an expert witness’s report that did not accurately summarize the witness’s views at the time he or she gave testimony. Often the process of discovery caused expert witnesses to modify their reports, whether through skillful inquiry at deposition, or through the submission of adversarial reports, or through changes in the evidentiary display between drafting the report and testifying at trial.

In other words, expert witnesses’ testimony rarely comes out exactly as it appears in words in Rule 26 reports. Furthermore, reports may be full of argumentative characterization of facts, which fail to survive routine objections and cross-examination. What is represented as a fact or a factual predicate of an opinion may never be cited in testimony because the expert’s representation was always false or hyperbolic. The expert witnesses are typically not percipient witnesses, and any alleged fact would not be admissible, under Rule 703, simply because it appeared in an expert witness’s report. Indeed, Rule 703 makes clear that expert witnesses can rely upon inadmissible hearsay as long as experts in their fields reasonably would do so in the ordinary course of their professions.

Voir dire of charts, graphs, and underlying data may result in large portions of an expert report becoming inadmissible. Not every objection will be submitted as a motion in limine; and not every objection rises to the level of a Rule 702 or 703 pre-trial motion to exclude the expert witness. Foundational lapses or gaps may render some parts of reports to be inadmissible.

The argument for admitting reports as evidence reflects a trend toward blowsy, frowsy jurisprudence. Judges should be listening carefully to testimony, both direct and cross, from expert witnesses. They will have transcripts at their disposal. Although the question and answer format of direct examination may take some time, it ensures the orderly presentation of admissible testimony.

Given that testimony often turns out differently from the unqualified statements in a pre-trial report, the proposed admissibility of reports will create evidentiary chaos when there a disparity between report and testimony, or there is a failure to elicit as testimony something that is stated in the report. Courts and litigants need an unequivocal record of what is in evidence when moving for striking testimony, or for directed verdicts, new trials, or judgments notwithstanding the verdict.

The proposed abridgement of expert witness direct examinations would allow further gaming by not calling an expert witness once the witness’s report has been filed. Expert witnesses may conveniently become unavailable, after their reports have been admitted into evidence.

In multi-district litigations, the course of litigation may take years and even decades. Reports filed early on may not reflect current views or the current state of the science. Deeming filed reports “admissible” could have a significant potential to subvert accurate fact finding.

In Ake v. General Motors Corp.[4], Chief Judge Larimer faced a plaintiff who sought to offer in evidence a report written by plaintiffs’ expert witness, who was scheduled to testify at trial. The trial court held, however, that the report was inadmissible hearsay, for which no exception was available.[5] The report at issue was not a business record, which might be admissible under Rule 803(6), in that it did not record events made at or near the event at issue, and the event did not involve the expert witness’s regularly conducted business activity.

There are plenty of areas of the law in which reforms are helpful and necessary. The formality of presenting an expert witness’s actual opinions, under oath, in open court, subject to objections and challenges, needs no abridgement.

[1] See, e.g., William Twining, “Bentham’s Theory of Evidence: Setting a Context,” 20 J. Bentham Studies 18 (2019); Kenneth M. Ehrenberg, “Less Evidence, Better Knowledge,” 2 McGill L.J. 173 (2015); Laird C. Kirkpatrick, “Scholarly and Institutional Challenges to the Law of Evidence: From Bentham to the ADR Movement,” 25 Loyola L.A. L. Rev. 837 (1992); Frederick N. Judson, “A Modern View of the Law Reforms of Jeremy Bentham,” 10 Columbia L. Rev. 41 (1910).

[2] See “Expert Witness Mining – Antic Proposals for Reform” (Nov. 4, 2014).

[3] Roger J. Marzulla, “Expert Reports: Objectionable Hearsay or Admissible Evidence in a Bench Trial?” A.B.A.(May 17, 2021).

[4] 942 F.Supp. 869 (W.D.N.Y. 1996).

[5] Ake v. General Motors Corp., 942 F.Supp. 869, 877 (W.D.N.Y. 1996).

Posted in Evidence, Expert Witness Discovery, Expert Witnesses, Trial Procedure | 187 Comments »

Disqualifying Expert Witnesses for Conflicts of Interest

March 30th, 2021

Some notes on vexing issue, which fortunately has never serious issue for me. I do recall a former partner, who with great exuberance, called every potential expert witness and then felt hurt when some of them showed up as trial witnesses on the other side. Of course, these turncoats bragged of having been approached by, and having rejected work for, the defense.

Side Switching

Opportunism or carelessness can sometimes affect expert witness retention in a way that results in “side switching.” Some lawyers may think it wonderful to snag the other side’s expert witness, who comes with a credibility credit for having been first identified by the other side. Although no rule or statute prohibits side switching, state and federal courts have exercised what they have called an inherent power to supervise and control ethical breaches by lawyers and expert witnesses.[1]

The Wang Test

Although certainly not the first case on side-switching, the decision of a federal trial court, in Wang Laboratories, Inc. v Toshiba Corp., has become a key precedent on disqualification of expert witnesses.[2] The test spelled out in the Wang case has generally been followed in federal courts,[3] as well as in state courts.[4] Given that most of the side-switching cases are quite fact sensitive, it is instructive to detail the facts that lead to an expert witness’s disqualification in this frequently cited case.

The Wang case, as far disqualification is concerned, began with a telephone call from Wang’s lawyer to a computer consultant. From Wang’s lawyer’s perspective, the call resulted in “retention.” The consultant denied that he was retained; as far as he was concerned, he agreed only to examine the patents at issue in the litigation, and to serve as an expert witness only if he were convinced of the patents’ validity.

After their telephone conference, Wang’s lawyer sent the consultant copies of the disputed patents, some materials suggesting an infringement, and the lawyer’s memorandum discussing the history of the prosecution of the patents. A short while later, the lawyer sent another memorandum, labeled “Confidential Attorney-Work Product,” which discussed potential defenses in the suit.

After providing these written materials, Wang’s lawyer had further conversations with the consultant about technical aspects of the case, and disclosed additional confidential information. The lawyer recounted that he had told the consultant that the conversations were confidential. The consultant denied receipt of any confidential information, and stated that he had not referred to the confidential memorandum because he had first to determine the validity of the patent. Working at a preliminary, investigatory stage, the consultant did not see himself as retained unless and until he concluded that the patents were valid.

Upon completed his preliminary investigation, the consultant concluded that the patents were not valid. The consultant informed Wang’s lawyer of his conclusion, and his decision to decline serving as an expert witness for Wang. Wang’s lawyer requested a short report from the consultant, who sent the requested report, which documented that he had read the patents and the “Work-Product” information.

After this interaction between Wang and the consultant, one of Wang’s adversaries, NEC approached the consultant and retained him as an expert witness. When NEC designated the consultant as an expert witness to be called at trial, Wang moved promptly to disqualify the consultant.

The Wang court recognized that if a retained expert witness receives confidential information and then switches sides, he or she is out. In Wang, both retention and receipt of confidential information were contested. The court held that both conditions were required for disqualification. Hence we have the two-prong Wang Test:

  1. A Confidential Relationship. This prong requires an inquiry into whether the party that claimed to have made the retention was objectively reasonable in concluding that a confidential relationship had been created between the party and the consultant. This fact-sensitive inquiry will typically turn on all the facts and circumstances surrounding the lawyer-consultant interaction, such as:
  • an agreement that contemplates sharing of confidential materials,
  • the lawyer’s having provided the consultant with confidential documents,
  • the existence of an agreement about retention,
  • the extent of the lawyer-consultant communications and meetings,
  • the payment of consideration for the consultant’s work, and
  • the extent of the consultant’s work and whether he or she formed any opinions about the issues in the case
  1. Secrets Shared. The second Wang prong inquires into whether confidential or privileged material had been shared with the consultant. The sharing of such information is evidence of a confidential relationship, but it is also required as an independent basis to satisfy the Wang court’s test. One party’s secret is another party’s commonplace, and the moving party must show that:
  • the information in question was specifically related to the case,
  • the information was privileged or confidential,
  • the information was not evidence that would have been discovered inevitably by the adversary, independent of the consultant’s side-switching
  • the information was not purely technical or otherwise in the public domain

In Wang, as in many similar cases, the lawyer and the consultant gave rather wildly inconsistent accounts of their interactions. The disputatious nature of disqualification motions is sadly all too common. The burden of proving both prongs of the Wang test is on the moving party, and in the Wang case, the court found that Wang’s lawyer had prevailed on both prongs. The consultant was disqualified.

The Wang two-prong test is the majority rule; both prongs must be satisfied. A minority of courts have disqualified expert witnesses “even if no disclosures occur,” in the name of the judicial process integrity.[5]

Public Policy Limits on Wang

Although the Wang test is sometimes characterized as a “bright-line” test, the Wang court itself was sensitive to potential abuse by lawyers who wished to silence certain expert witnesses by creating what appears to be a confidential relationship without actually sharing confidential information. After Wang, some courts moved beyond the two-part test to consider the policy implications of the requested disqualification.[6] Some of the policy considerations that have been advanced and been factored into judicial decisions whether to disqualify an expert witness include:

  • protecting freedom of contract, and the consultant’s right to pursue a livelihood,
  • preventing “sham” retentions to set up later disqualification, especially when there is a limited availability of qualified expert witnesses on the issues, and
  • preventing prejudice to the innocent second party that approached the consultant.

Procedural Issues

Burden of Proof. The case law clearly places the burden of proving the elements of disqualification on the moving party.

Timeliness of Objections. The case law also makes clear that a party must move promptly to object to an expert witness’s conflict of interest.[7]

Not the same product, but similar product, in a later case

When the expert witness in question testified for an adversary in a different case, the analysis of confidential aspect of the shared information becomes more difficult.

Mass Tort Cases

In mass tort cases, many individual plaintiffs have typically sued a single or limited group of defendants. Such litigation can take decades to resolve, or may even become a perpetual motion litigation machine, such as asbestos personal injury cases. Such litigation creates a great need for expert witnesses on various topics, and the duration of the litigation may lead to innocent or deliberate recruitment of the other side’s former expert witnesses.

In one Fen-Phen case, one plaintiff sought to retain an expert witness previously retained by Wyeth to testify about the same diet drug (fenfluramine) in a case brought by a different plaintiff. The trial court readily concluded that there was clear overlap, with sufficient evidence that Wyeth had shared its confidential case strategies and confidential information related to the same drug.[8]

In some instances of side switching, the allegedly defective product may have been similar but not the same. Determining how much overlap makes the sharing harmful of confidential information has proceeded on a case-by-case basis. One thing, however, is clear: there is no overarching duty of loyalty. In one case, a federal court allowed expert witnesses to testify for and against the same defendant in concurrent patent litigation.[9] The court reasoned that the expert witnesses’ testimony in each case addressed only the specific, different patents in the case, and there was no overall sharing of general litigation strategy common to both cases. The testimony in each case did not overlap with the testimony in the other case. The challenge failed to show that confidences were shared that affected both cases.

One New Jersey appellate court upheld the disqualification of an expert witness who had worked for the State of New Jersey on a case that involved confidential disclosures by the State’s lawyers and its agencies, which disclosures were necessarily involved in the expert witness’s subsequent retention by the State’s adversary in a different case.[10] This decision, like most in this area, turned on a close analysis of the facts and circumstances of the retentions and consultations of the expert witness.

Practice Considerations

Obviously, lawyers must research consultants before approaching them. After making contact with a consultant, it is incumbent upon counsel to ask the consultant specifically about past and current engagements and any confidentiality limitations.[11]

Lawyers should clearly communicate their intention to create a confidential relationship that will permit candid exchange of views and information; consultants should similarly express their reservations and doubts about entering into such the proposed working relationship.[12]

In entertaining motions for disqualification, courts generally want to see confirmation of retention in writing.[13] Such writings should recite agreements on fees, billing, payment, as well as an explanation of the nature of the consulting relationship and the anticipation of shared confidences. Some commentators have suggested, imprudently in my view, that the agreement specifically prohibit side switching.

After the consultancy has begun, lawyers should clearly label their work-product communications. The 2010 amendments to the Federal Rules of Civil Procedure protect such communications from discovery in the litigation process.[14] The 2010 amendments did not, however, protect communications relating to compensation, or the lawyer’s identification of facts or data, which the expert witness then considered in forming opinions, or the lawyer’s identification of assumptions to be made by the expert witness in reaching opinions.[15]  Lawyers must exercise great care in navigating the relevant state and federal rules to protect their work-product that has been shared with expert witnesses who will be disclosed as trial witnesses.

Role and Relationship Conflict

Managerial Employees

A company’s former executives or former high-level employees who had access to internal, deliberative and confidential communications, such as communications with legal counsel, are off limits to an adversary that wishes to engage the former employees as expert witnesses in litigation involving the confidences.

Treating Physicians

Treating physicians act in a role of sharing confidences and trust with their patients. Generally, courts have disallowed parties from engaging physicians as expert witnesses in litigation against the physicians’ patients. In mass tort litigation, however, courts have been willing to permit physicians to serve as expert witnesses, even when some of their patients are plaintiffs, as long as they serve as expert witnesses only in cases brought by non-patients.

Physicians frequently have important factual testimony that bears on litigation, and courts have rejected disqualification of physicians as fact witnesses. In Ngo v. Standard Tools & Equip. Co., Inc., 197 F.R.D. 263 (D. Md. 2000), the court rejected plaintiff’s attempt to disqualify his own treating physician as a defense witness. The plaintiff claimed that he and his counsel had engaged the physician as an expert witness, but the court found that no confidential relationship had been formed. The physician was allowed to testify as a fact witness for the defense. It would be extremely unlikely that an engagement of the physician as a consulting expert witness would have prevented the adverse party from calling the physician as a fact witness, in any event.

Treating Psychotherapists

The psychotherapy-patient relationship is one in which the very nature of the relationship may disqualify the psychotherapist from acting as an expert witness in support of a patient’s claim. The psychiatric profession generally recognizes that providing therapy to a patient and forensic services in support of the patient’s legal claims can adversely affect the therapeutic relationship and impair the therapist’s objectivity as an expert witness.[16] Interestingly, there is not much case law on this potential source of disqualification. In one uncelebrated case, a motion to disqualify a treating psychiatrist from serving as an expert witness was filed, but the case was dismissed on other grounds.[17]

——————————————————————————————–

[1] Grant Thornton, LLP v. Fed. Deposit lnsur. Corp., 297 F. Supp. 2d 880, 881-82 (S.D. W.Va. 2004); Wang Lab., lnc. v. Toshiba Corp., 762 F. Supp. 1246, 1248 (E.D. Va. 1991) (“protect the integrity of the adversary process and promote public confidence in the fairness and integrity of the legal process”).

[2] 762 F. Supp. 1246 (E.D. Va. 1991); see also Vershuta, “New Rules of War in the Battle of the Experts: Amending the Expert Witness Disqualification Test for Conflicts of Interest,” 81 Brooklyn L. Rev. 733 (2016); Brian Hooven, “The Science Behind Expert Disqualification: A Guide,” 12 Expert Witnesses 13 (Fall 2016); Lynne Bernabei, Matthew Radler & Lauren R. S. Mendonsa “Ethical Duties and Standards in Disqualifying, Retaining, and Communicating with Expert Witnesses,” 43 Brief 1 (2013); Maya M. Eckstein & Paul Nyffeler, “The Expert of My Enemy Is My Expert: Conflicts of Interests Amongst Expert Witnesses,” 17 Litig. News 1 (Summer 2012); Douglas R. Widin & Francis J. Maloney III, “Conflicts of Interest and Litigation Experts,” chap. 4, in Cynthia H. Cwik, ed., Scientific Evidence Review: Current Issues at the Crossroads of Science, Technology and the Law, Monograph No. 7 (2006); Cathy Altman & Dena Denooyer Stroh, “Keeping It Confidential: Disqualifying Experts,” Commerical & Bus. Litig. J. 10 (Spring 2005); Kendall Coffey, “Inherent judicial Authority and the Expert Disqualification Doctrine,” 56 Fla. L. Rev. 195 (2004); Douglas R. Richmond, “Regulating Expert Testimony,” 62 Mo. L. Rev. 485 (1997).

[3] See, e.g., Greene, Tweed of Delaware, Inc. v. DuPont Dow Elastomers, LLC, 202 F.R.D. 426, 429 (E.D. Pa. 2001); In re Orthopedic Bone Screw Prod. Liab. Litig., 1995 U.S. Dist. LEXIS 21526 at *8 (E.D. Pa. 1995); Hewlett-Packard Co. v. EMC Corp., 330 F. Supp. 2d 1087, 1092-093 (N.D. Cal. 2004); Crenshawv. Mony Life Ins. Co., 318 F. Supp. 2d 1015, 1026 (S.D. Cal. 2004); Syngenta Seeds, Inc. v. Monsanto Co., 2004 WL 2223252 at *2, No. 02-1331-SLR (D. Del Sept. 27, 2004); Mays v. Reassure America Life Ins. Co., 293 F. Supp. 2d 954, 957 (E.D. Ark. 2003); Cordy v. Sherwin-Williams Co., 156 F.RD. 575, 580 (D.N.J. 1994); English Feedlot, Inc. v. Norden Lab., Inc., 833 F. Supp. 1498, 1452 (D. Colo. 1993).

[4] See, e.g., Mitchell v. Wilmore, 981 P.2d 172, 175 (Colo. 1999); Formosa Plastics Corp., U.S.A. v. Kajima Internat’l, Inc., 2004 WL 2534207 at *2 (Tex. Ct. App. Nov. 10, 2004), rev. denied, 15 S.W.3d 289 (Tex. 2004); Turner v. Thiel, 553 S.E.2d 765, 768 (Va. 2001).

[5] City of Springfield v. RHI Holdings, Inc., 111 F. Supp. 2d 71, 74 (D. Mass. 2000).

[6] See, e.g., Cordy v. Sherwin-Williams Co., 156 F.R.D. 575 (D.N.J. 1994).

[7] See Popular, Inc. v. Popular Staffing Services. Corp., 239 F. Supp. 2d 150, 153 (D. Puerto Rico 2003).

[8] Righetti v. Wyeth, Inc., No. 07-20144, 2009 WL 1886131 (E.D. Pa. 2009). See also Rhodes v. E.I. Du Pont De Nemours & Co., 558 F. Supp. 2d 660 (2008).

[9] Bone Care Internat’l, LLC v. Pentech Pharms, Inc., 2009 WL 249386, at *2–3 (N.D. Ill. Feb. 2, 2009).

[10] Conforti & Eisele, Inc. v. Div. of Bldg. & Constr., 405 A.2d 487 (N.J. Super. Ct., L. Div. 1979) (noting that the court’s “decision should in no way be read to indicate that an expert who has traditionally been hired by one attorney in a particular type of litigation would be precluded from offering his services to that particular attorney’s adversary in an unrelated matter”).

[11] English Feedlot, Inc. v. Norden Lab., Inc., 833 F. Supp. 1498, 1505 (D. Colo. 1993) (“[C)ounsel seeking to retain a consultant should inquire specifically whether the consultant’s past employment presents any confidentiality roblems.”).

[12] Wang Lab., lnc. v. Toshiba Corp., 762 F. Supp. 1246, 1246, 1248-49 (E.D. Va. 1991) (noting that fairness require that lawyers bear a burden to communicate to consultants that they desire and intend to create a confidential relationship, and that consultants express their doubts unequivocally and decline any disclosures until their doubts are resolved).

[13] See, e.g., id. at 1249-50; Syngenta Seeds, Inc. v. Monsanto Co., 2004 WL 2223252 at *2 (D. Del. Sept. 27, 2004); See also Hewlett-Packard Co. v. EMC Corp., 330 F. Supp. 2d 1087, 1091 (N.D. Cal. 2004) (discussing the practical importance of written retention agreements).

[14] Fed. R. Civ. P. 26(b)(4)(B), (C).

[15] Fed. R. Civ. P. 26(b)(4)(C)(i)-(iii).

[16] Psychiatrists’ Program, “Can a Treating Psychiatrist Double As Expert Witness for Same Patient?” 39 Psychiatric News at 16 (Aug. 20, 2004); “Assuming Conflicting Roles Can Be Risky,” 36 Psychiatric News at 25 (Oct. 19, 2001); see also Larry H. Strasburger, Thomas G. Gutheil & Archie Brodsky, “On Wearing Two Hats: Role Conflict in Serving as Both Psychotherapist and Expert Witness,” 154 Am. J. Psychiatry 448 (1997).

[17] Conant v. Tru-Test Manufacturing Co., N.J. Law Div., Burlington Cty. No. L-03214-97 (Oct. 25, 2002).

Posted in Conflicts of Interest, Expert Witness Discovery | 381 Comments »

Lawsuit Industry Expert Witness Robert Neel Proctor’s Intimidation Tactics

December 25th, 2020

In his autobiography, Sir Karl Popper described one of the most curious and interesting confrontations in 20th century philosophy. While visiting Cambridge University to give a guest lecture, Popper was hectored by the renown chairman of the philosophy department, Ludwig Wittgenstein. While nervously playing with a fireplace poker and waving it about for emphasis, Wittgenstein challenged Popper to provide an example of a moral rule. Popper rejoined “Not to threaten visiting lecturers with pokers,” after which Wittgenstein threw down the poker and stormed out of the room.[1]

A more recent anecdote in this century gives rise to another moral rule, “thou shalt not bully graduate students working for your adversary.”

The law firm of Jones Day, representing tobacco mega-defendant R. J. Reynolds in personal injury lawsuits, was working with Associate Professor Gregg L. Michel, at the University of Texas. Michel needed research assistants to help with this litigation consulting work, and so in 2008, he reached out to J. Matthew Gallman, a professor of history at the University of Florida, to help line up some worker bees. Gallman helped Michel hire four master-level graduate students from Gallman’s department.

Tobacco lawsuit industry testifier Associate Professor Louis M. Kyriakoudes, at University of Southern Mississippi, learned of the arrangement from his involvement in tobacco litigation. Kyriakoudes shared the information with his fellow-traveling expert witness for tobacco plaintiffs, Robert Neel Proctor.

There was no impropriety in Michel’s hiring the graduate students to assist with his research. Parties are allowed to have consulting expert witness, if for no other reason than to test the accuracy of the other side’s expert witness’s opinions. The research assignment involved searching the archives of a local Pensacola newspaper, in the 1940s, for coverage of smoking’s ill health effects. According to Gallman, the students were “explicitly told not to be selective,” to favor one party or the other.

Proctor was, and still is, a highly paid expert witness for the tobacco lawsuit industry, that is the plaintiffs’ bar, and a regular feature of tobacco trials. After learning the names of the graduate students from his litigation work, Proctor in turn contacted Professor Vassiliki Betty Smocovitis, who held joint appointments in the University of Florida history and biology departments.[2]

In a fairly obvious effort to intimidate and harass the students, Proctor revealed the students’ names to Smocovitis, and pressed his tendentious, gratuitous opinion:

“In my view this is historical malpractice, and I would be very interested to know if the advisers of these students know what they have been doing.”

Smocovitis, who had never been involved in litigation as a partisan expert witness, dutifully carried out the inquiry for Proctor, only to find, unsurprisingly, that her colleagues did not believe that the students had done anything improper. According to her emails, Smocovitis reported back to Proctor that her departmental colleagues were indifferent or annoyed or both for her having bothered them with Proctor’s issue. She told Proctor that “I’m afraid that this is a case of ‘shoot the messenger’, so I can’t persist without alienating myself further,” She resisted Proctor’s importuning to raise the issue at a faculty meeting.

Lawyers at Jones Day sought emails of Proctor and Kyriakoudes from their university servers, and ultimately took depositions of Proctor and Kyriakoudes, the plaintiffs’ expert witnesses, and Smocovitis, in support of motions to sanction Proctor. Michel filed an affidavit in which he described how one of the four students had been led to believe by her departmental chairman, Joseph F. Spillane, that Proctor intended to publish her name.

Kyriakoudes, who dropped the dime on the graduate students, suggested in his deposition that Proctor’s intrusion into the University of Florida department was a “tactical mistake.” According the Chronicle of Higher Education, he testified that “[t]his whole business of getting involved in a department’s activities like this is just—it’s caused no end of trouble.”

In his own deposition, Proctor described the communications as:

“legitimate scholarly inquiry into the participation of historians in litigation.”

* * *

“I was simply raising an ethical issue that she might want to discuss.”

Sort of like Trump’s perfect conversation with President Volodymyr Zelensky. In Trumpian turn-around, Proctor complained that he was real victim of witness harassment and bullying by the defense counsel, in an effort to “silence him.” Ah, the flexibility of historical narrative!

What really seemed to irk Proctor was that any historian, even master-level graduate students, would disagree with him, or find historical evidence that embarrassed Proctor’s litigation positions. Proctor’s blindness to his own bad behavior in the recent past, certainly raises questions about his historical acumen.

Proctor’s play at grievance victimhood was amplified by the obsequious scholarship of Jon Wiener. In the pages of The Nation, Wiener incorrectly reported that “[n]othing improper was found, no witness tampering or intimidation, and the tobacco attorneys dropped the issue–for a while.”[3] In fact, as an historical matter, Wiener was quite wrong.

Judgment Day

The Jones Day lawyers’ motion claimed that Proctor’s improprieties was part of a pattern of behavior that stemmed from his “uncontrolled zeal to win.” Proctor, a paid advocate for the tobacco lawsuit industry, thought it was within his mandate to expose the connection between tobacco defense and historians. In doing so, he engaged in witness tampering and harassment. Proctor and his employers in the lawsuit industry responded with an attempt to portray Proctor’s ham-fisted inquiries as concern for the vulnerable graduate students who were not receiving “guidance,” which would impair their future careers.

The Motion contra Proctor came before Judge Williams Parsons, in the Volusia County Circuit Court.[4] Contrary to the Wiener report, Judge Parsons found that Proctor indeed had intended to harass and humiliate the students into abandoning their litigation support work. Judge Parsons described Proctor’s willingness to advance the plaintiffs’ case at the students’ expense as “appalling,” and “the lowest of the low.” The defense had sought Proctor’s exclusion, but Judge Parsons declined to impose this extreme sanction in favor of barring Proctor from having any contact with adversary expert witnesses or their assistants.

Conduct the following thought experiment. Imagine an historian who testifies for the defense in tobacco litigation finds out that Proctor had hired graduate students to help with research. The defense historian calls up the students’ supervisors to suggest that they are acting unethically and unprofessionally. Now close your eyes and listen to the outcry from the Wieners of the world, or from the American Historical Association! Even after the ugly facts were disclosed, there were some in in the academic historian establishment who rallied to Proctor’s defense, and tried to give Wiener cover for his mendacious coverage of the graduate student incident.[5]

Lancet-ing Adversary Expert Witnesses

Proctor’s attempt to exploit vulnerable history graduate students was not his first attempt to silence historians who disagree with him. Proctor, who has stridently criticized tobacco defense counsel for trying to “silence him,” has worked assiduously to try to silence historians who work for the other side. In a commentary piece in The Lancet, Proctor criticized colleagues who have worked on historical issues for tobacco companies’ legal defense.[6] Proctor substantively criticized his adversaries’ testimony, without providing much in the way of detail, and he implied that their work was ethically improper and rife with conflicts of interest. Perhaps more telling, Proctor himself gave conflicts disclosure that he had “worked on several occasions as an expert witness in plaintiff’s lawsuits,” without telling his readers that he was highly compensated for work.

Proctor’s one-sided analysis provoked spirited opposition from several distinguished medical historians who refused to be bullied or to acquiesce in his moral grandstanding. John C. Burnham, a Professor of History at The Ohio State, wrote a scathing letter to the Lancet’s editors, as well as opinion pieces in History News Network.[7] David Rothman, a professor at Columbia University, similarly took Proctor to task for his pretensions of doing “history” while testifying for the lawsuit industry.[8]

Perhaps the most telling rebuttal came from Professor Alan Blum, a physician and anti-tobacco activist. Dr. Blum, who is the Director of Center for the Study of Tobacco & Society, and a chaired professor at the University of Alabama, is a leading authority on the history of tobacco use and the depradations of the tobacco industry. Professor Blum found Proctor’s animadversions a bit too sanctimonious given that Proctor himself has been a compensated expert witness for the tobacco lawsuit industry.[9]

Conflicted Friends of the Court

The friend of the court brief, from disinterested third parties, is an important, potentially useful source of extra-record information and opinion for judges, both in trial and appellate courts. Historians can on occasion have important historical information, necessary for adjudication. For instance, in the theocratic zeal to strip women of their reproductive rights, historians have adduced important scholarship that abortion was lawful in all thirteen colonies at the time of the Constitutional ratification.  In the context of amicus briefs, historians of course can and do overstep their distinterested roles to act as legal advocates.[10]

Speaking of overstepping, Robert Proctor filed an amicus brief in Altria Group, Inc. v. Good, which involved a tobacco industry’s challenge to Federal Trade Commission control of advertising for “light” or “lowered tar” cigarettes.[11] Accompanying Proctor were four other signatories, Allan M. Brandt, David M. Burns, Jonathan M. Samet and David Rosner.

All except for Brandt had testified multiple times as expert witnesses. Brandt, Proctor, and Samet acknowledged having testified as expert witnesses in United States v. Philip Morris USA, Inc.[12] They all conveniently forgot to note that they were remunerated, and that they had testified against Philip Morris USA, Inc. Burns, who testified as an expert witness in United States v. Philip Morris USA, Inc., failed to mention his testimonial role in that case, as well as many other tobacco cases in support of the lawsuit industry. Rosner, who had not testified in tobacco cases, failed to mention his many paid testimonial adventures for the lawsuit industry.[13]

[1] Karl Popper, Unended Quest: An Intellectual Autobiography at 141-43 (rev. ed. 2005), first published as “Autobiography by Karl Popper,” in Paul Arthur Schlipp, ed., The Philosophy of Karl Popper (1974). The incident is the subject of a book-long inquiry. David Edmonds & John Eidinow, Wittgenstein’s Poker: The Story of a Ten-Minute Argument Between Two Great Philosophers (2001).

[2] Peter Schmidt, “Big Tobacco Strikes Back at Historian in Court,” The Chronicle of Higher Education (Nov. 8, 2009).

[3] Jon Wiener, “Big Tobacco and the Historians: A tale of seduction and intimidation,” The Nation (Feb. 25, 2010).

[4] Nathan Crabbe, “UF students caught in middle of tobacco case’s controversy,” The Gainesville Sun (Dec 8, 2009).

[5]  See “More debate over Jon Wiener’s tobacco exposé,” History News Network (Dec. 13, 2010).

[6] Robert N. Proctor, “Should medical historians be working for the tobacco industry?” 363 Lancet 1173 (2004).

[7] John C. Burnham, “Medical historians and the tobacco industry,” 364 Lancet 838 (2004); John C. Burnham, “In Defense of Historians as Expert Witnesses: A Rebuttal to Jon Wiener,” History News Network (Mar. 29, 2010).

[8] David Rothman, “Medical historians and the tobacco industry,” 364 Lancet 839 (2004). See also Patricia Cohen, “Historians for Hire in Industry Lawsuits,” N.Y. Times (June 13, 2003) (quoting David J. Rothman,  director of the Center for the Study of Science and Medicine at the Columbia College of Physicians and Surgeons, concludes, “To enter the courtroom is to do many things, but it is not to do history”).

[9] Alan Blum, “A Dissenting View of Robert Proctor by a Fellow Anti-Smoking Advocate,” History Network News (April 26, 2010).

[10] Nell Gluckman, “Why More Historians Are Embracing the Amicus Brief,” The Chronicle of Higher Education (May 3, 2017) (quoting Harvard history professor Tomiko Brown-Nagin’s observation that “[t]o be a legal advocate is freeing”; Brown-Nagin filed an amicus brief in the 2013 Supreme Court case involving racist policies at the University of Texas).

[11]  Amicus Brief of Allan M. Brandt, Robert N. Proctor, David M. Burns, Jonathan M. Samet & David Rosner, in Support of Petition for Certiorari, in Altria Group, Inc. v. Good, No. 07-562, 2008 WL 2472390, (U.S. Supreme Court June 18, 2008).

[12] United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1 (D.D.C. 2006).

[13] “The Amicus Curious Brief” (Jan. 4, 2018) (describing Rosner and many other plaintiffs’ expert witnesses’ failure to disclose their testimonial conflicts of interest when writing and filing an amicus brief in litigation that directly affected the economic viability of their testimony in asbestos cases for the lawsuit industry).

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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

Mass Torts Made Less Bad – The Zambelli-Weiner Affair in the Zofran MDL

July 30th, 2019

Judge Saylor, who presides over the Zofran MDL, handed down his opinion on the Zambelli-Weiner affair, on July 25, 2019.[1] As discussed on these pages back in April of this year,[2] GlaxoSmithKline (GSK), the defendant in the Zofran birth defects litigation, sought documents from plaintiffs and Dr Zambelli-Weiner (ZW) about her published study on Zofran and birth defects.[3] Plaintiffs refused to respond to the discovery on grounds of attorney work product,[4] and of consulting expert witness confidential communications.[5] After an abstract of ZW’s study appeared in print, GSK subpoenaed ZW and her co-author, Dr. Russell Kirby, for a deposition and for production of documents.

Plaintiffs’ counsel sought a protective order. Their opposition relied upon a characterization of ZW as a research scientist; they conveniently ommitted their retention of her as a paid expert witness. In December 2018, the MDL court denied plaintiffs’ motion for a protective order, and allowed the deposition to go forward to explore the financial relationship between counsel and ZW.

In January 2019, when GSK served ZW with its subpoena duces tecum, ZW through her own counsel moved for a protective order, supported by ZW’s affidavit with factual assertions to support her claim to be not subject to the deposition. The MDL court quickly denied her motion, and in short order, her lawyer notified the court that ZW’s affidavit contained “factual misrepresentations,” which she refused to correct, and he sought leave to withdraw.

According to the MDL court, the ZW affidavit contained three falsehoods. She claimed not to have been retained by any party when she had been a paid consultant to plaintiffs at times over the previous five years, since December 2014. ZW claimed that she had no factual information about the litigation, when in fact she had participated in a Las Vegas plaintiffs’ lawyers’ conference, “Mass Torts Made Perfect,” in October 2015. Furthermore, ZW falsely claimed that monies received from plaintiffs’ law firms did not go to fund the Zofran study, but went to her company, Translational Technologies International Health Research & Economics, for unrelated work. ZW received in excess of $200,000 for her work on the Zofran study.

After ZW obtained new counsel, she gave deposition testimony in February 2019, when she acknowledged the receipt of money for the study, and the lengthy relationship with plaintiffs’ counsel. Armed with this information, GSK moved for full responses to its document requests. Again, plaintiffs’ counsel and ZW resisted on grounds of confidentiality and privilege.

Judge Saylor reviewed the requested documents in camera, and held last week that they were not protected by consulting expert witness privilege or by attorney work product confidentiality. ZW’s materials and communications in connection with the Las Vegas plaintiffs’ conference never had the protection of privilege or confidentiality. ZW presented at a “quasi-public” conference attended by lawyers who had no connection to the Zofran litigation.[6]

With respect to work product claims, Judge Saylor found that GSK had shown “exceptional circumstances” and “substantial need” for the requested materials given that the plaintiffs’ testifying expert witnesses had relied upon the ZW study, which had been covertly financially supported by plaintiffs’ lawyers.[7] With respect to whatever was thinly claimed to be privileged and confidential, Judge Saylor found the whole arrangement to fail the smell test:[8]

“It is troublesome, to say the least, for a party to engage a consulting, non-testifying expert; pay for that individual to conduct and publish a study, or otherwise affect or influence the study; engage a testifying expert who relies upon the study; and then cloak the details of the arrangement with the consulting expert in the confidentiality protections of Rule 26(b) in order to conceal it from a party opponent and the Court. The Court can see no valid reason to permit such an arrangement to avoid the light of discovery and the adversarial process. Under the circumstances, GSK has made a showing of substantial need and an inability to obtain these documents by other means without undue hardship.

Furthermore, in this case, the consulting expert made false statements to the Court as to the nature of her relationship with plaintiffs’ counsel. The Court would not have been made aware of those falsehoods but for the fact that her attorney became aware of the issue and sought to withdraw. Certainly plaintiffs’ counsel did nothing at the time to correct the false impressions created by the affidavit. At a minimum, the submission of those falsehoods effectively waived whatever protections might otherwise apply. The need to discover the truth and correct the record surely outweighs any countervailing policy in favor of secrecy, particularly where plaintiffs’ testifying experts have relied heavily on Dr. Zambelli-Weiner’s study as a basis for their causation opinions. In order to effectively cross-examine plaintiffs’ experts about those opinions at trial, GSK is entitled to review the documents. At a minimum, the documents shed additional light on the nature of the relationship between Dr. Zambelli-Weiner and plaintiffs’ counsel, and go directly to the credibility of Dr. Zambelli-Weiner and the reliability of her study results.”

It remains to be seen whether Judge Saylor will refer the matter of ZW’s false statements in her affidavit to the U.S. Attorney’s office, or the lawyers’ complicity in perpetuating these falsehoods to disciplinary boards.

Mass torts will never be perfect, or even very good. Judge Saylor, however, has managed to make the Zofran litigation a little less bad.

[1]  Memorandum and order on In Camera Production of Documents Concerning Dr. April Zambelli-Weiner, In re Zofran Prods. Liab. Litig., MDL 2657, D.Mass. (July 25, 2019) [cited as Mem.].

[2]  NAS, “Litigation Science – In re Zambelli-Weiner” (April 8, 2019).

[3]  April Zambelli-Weiner, et al., “First Trimester Ondansetron Exposure and Risk of Structual Birth Defects,” 83 Reproductive Toxicol. 14 (2019).

[4]  Fed. R. Civ. P. 26(b)(3).

[5]  Fed. R. Civ. P. 26(b)(4)(D).

[6]  Mem. at 7-9.

[7]  Mem. at 9.

[8]  Mem. at 9-10.

Posted in Conflicts of Interest, Data Sharing, Expert Witness Discovery, Scientific Misconduct | Comments Off on Mass Torts Made Less Bad – The Zambelli-Weiner Affair in the Zofran MDL

Science Bench Book for Judges

July 13th, 2019

On July 1st of this year, the National Judicial College and the Justice Speakers Institute, LLC released an online publication of the Science Bench Book for Judges [Bench Book]. The Bench Book sets out to cover much of the substantive material already covered by the Federal Judicial Center’s Reference Manual:

Acknowledgments

Table of Contents

  1. Introduction: Why This Bench Book?
  2. What is Science?
  3. Scientific Evidence
  4. Introduction to Research Terminology and Concepts
  5. Pre-Trial Civil
  6. Pre-trial Criminal
  7. Trial
  8. Juvenile Court
  9. The Expert Witness
  10. Evidence-Based Sentencing
  11. Post Sentencing Supervision
  12. Civil Post Trial Proceedings
  13. Conclusion: Judges—The Gatekeepers of Scientific Evidence

Appendix 1 – Frye/Daubert—State-by-State

Appendix 2 – Sample Orders for Criminal Discovery

Appendix 3 – Biographies

The Bench Book gives some good advice in very general terms about the need to consider study validity,[1] and to approach scientific evidence with care and “healthy skepticism.”[2] When the Bench Book attempts to instruct on what it represents the scientific method of hypothesis testing, the good advice unravels:

“A scientific hypothesis simply cannot be proved. Statisticians attempt to solve this dilemma by adopting an alternate [sic] hypothesis – the null hypothesis. The null hypothesis is the opposite of the scientific hypothesis. It assumes that the scientific hypothesis is not true. The researcher conducts a statistical analysis of the study data to see if the null hypothesis can be rejected. If the null hypothesis is found to be untrue, the data support the scientific hypothesis as true.”[3]

Even in experimental settings, a statistical analysis of the data do not lead to a conclusion that the null hypothesis is untrue, as opposed to not reasonably compatible with the study’s data. In observational studies, the statistical analysis must acknowledge whether and to what extent the study has excluded bias and confounding. When the Bench Book turns to speak of statistical significance, more trouble ensues:

“The goal of an experiment, or observational study, is to achieve results that are statistically significant; that is, not occurring by chance.”[4]

In the world of result-oriented science, and scientific advocacy, it is perhaps true that scientists seek to achieve statistically significant results. Still, it seems crass to come right out and say so, as opposed to saying that the scientists are querying the data to see whether they are compatible with the null hypothesis. This first pass at statistical significance is only mildly astray compared with the Bench Book’s more serious attempts to define statistical significance and confidence intervals:

“4.10 Statistical Significance

The research field agrees that study outcomes must demonstrate they are not the result of random chance. Leaving room for an error of .05, the study must achieve a 95% level of confidence that the results were the product of the study. This is denoted as p ≤ 05. (or .01 or .1).”[5]

and

“The confidence interval is also a way to gauge the reliability of an estimate. The confidence interval predicts the parameters within which a sample value will fall. It looks at the distance from the mean a value will fall, and is measured by using standard deviations. For example, if all values fall within 2 standard deviations from the mean, about 95% of the values will be within that range.”[6]

Of course, the interval speaks to the precision of the estimate, not its reliability, but that is a small point. These definitions are virtually guaranteed to confuse judges into conflating statistical significance and the coefficient of confidence with the legal burden of proof probability.

The Bench Book runs into problems in interpreting legal decisions, which would seem softer grist for the judicial mill. The authors present dictum from the Daubert decision as though it were a holding:[7]

“As noted in Daubert, ‘[t]he focus, of course, must be solely on principles and methodology, not on the conclusions they generate’.”

The authors fail to mention that this dictum was abandoned in Joiner, and that it is specifically rejected by statute, in the 2000 revision to the Federal Rule of Evidence 702.

Early in the Bench Book, it authors present a subsection entitled “The Myth of Scientific Objectivity,” which they might have borrowed from Feyerabend or Derrida. The heading appears misleading because the text contradicts it:

“Scientists often develop emotional attachments to their work—it can be difficult to abandon an idea. Regardless of bias, the strongest intellectual argument, based on accepted scientific hypotheses, will always prevail, but the road to that conclusion may be fraught with scholarly cul-de-sacs.”[8]

In a similar vein, the authors misleadingly tell readers that “the forefront of science is rarely encountered in court,” and so “much of the science mentioned there shall be considered established….”[9] Of course, the reality is that many causal claims presented in court have already been rejected or held to be indeterminate by the scientific community. And just when readers may think themselves safe from the goblins of nihilism, the authors launch into a theory of naïve probabilism that science is just placing subjective probabilities upon data, based upon preconceived biases and beliefs:

“All of these biases and beliefs play into the process of weighing data, a critical aspect of science. Placing weight on a result is the process of assigning a probability to an outcome. Everything in the universe can be expressed in probabilities.”[10]

So help the expert witness who honestly (and correctly) testifies that the causal claim or its rejection cannot be expressed as a probability statement!

Although I have not read all of the Bench Book closely, there appears to be no meaningful discussion of Rule 703, or of the need to access underlying data to ensure that the proffered scientific opinion under scrutiny has used appropriate methodologies at every step in its development. Even a 412 text cannot address every issue, but this one does little to help the judicial reader find more in-depth help on statistical and scientific methodological issues that arise in occupational and environmental disease claims, and in pharmaceutical products litigation.

The organizations involved in this Bench Book appear to be honest brokers of remedial education for judges. The writing of this Bench Book was funded by the State Justice Institute (SJI) Which is a creation of federal legislation enacted with the laudatory goal of improving the quality of judging in state courts.[11] Despite its provenance in federal legislation, the SJI is a a private, nonprofit corporation, governed by 11 directors appointed by the President, and confirmed by the Senate. A majority of the directors (six) are state court judges, one state court administrator, and four members of the public (no more than two from any one political party). The function of the SJI is to award grants to improve judging in state courts.

The National Judicial College (NJC) originated in the early 1960s, from the efforts of the American Bar Association, American Judicature Society and the Institute of Judicial Administration, to provide education for judges. In 1977, the NJC became a Nevada not-for-profit (501)(c)(3) educational corporation, which its campus at the University of Nevada, Reno, where judges could go for training and recreational activities.

The Justice Speakers Institute appears to be a for-profit company that provides educational resources for judge. A Press Release touts the Bench Book and follow-on webinars. Caveat emptor.

The rationale for this Bench Book is open to question. Unlike the Reference Manual for Scientific Evidence, which was co-produced by the Federal Judicial Center and the National Academies of Science, the Bench Book’s authors are lawyers and judges, without any subject-matter expertise. Unlike the Reference Manual, the Bench Book’s chapters have no scientist or statistician authors, and it shows. Remarkably, the Bench Book does not appear to cite to the Reference Manual or the Manual on Complex Litigation, at any point in its discussion of the federal law of expert witnesses or of scientific or statistical method. Perhaps taxpayers would have been spared substantial expense if state judges were simply encouraged to read the Reference Manual.

[1]  Bench Book at 190.

[2]  Bench Book at 174 (“Given the large amount of statistical information contained in expert reports, as well as in the daily lives of the general society, the ability to be a competent consumer of scientific reports is challenging. Effective critical review of scientific information requires vigilance, and some healthy skepticism.”).

[3]  Bench Book at 137; see also id. at 162.

[4]  Bench Book at 148.

[5]  Bench Book at 160.

[6]  Bench Book at 152.

[7]  Bench Book at 233, quoting Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 595 (1993).

[8]  Bench Book at 10.

[9]  Id. at 10.

[10]  Id. at 10.

[11] See State Justice Institute Act of 1984 (42 U.S.C. ch. 113, 42 U.S.C. § 10701 et seq.).

Posted in Causation, Evidence, Expert Witness Discovery, Expert Witnesses, Frye, Reference Manual on Scientific Evidence, Rule 702, Rule 703, Scientific Evidence, statistical evidence | Comments Off on Science Bench Book for Judges

Litigation Science – In re Zambelli-Weiner

April 8th, 2019

Back in 2001, in the aftermath of the silicone gel breast implant litigation, I participated in a Federal Judicial Center (FJC) television production of “Science in the Courtroom, program 6” (2001). Program six was a round-table discussion among the directors (past, present, and future) of the FJC, all of whom were sitting federal judges, with two lawyers in private practice, Elizabeth Cabraser and me.1 One of the more exasperating moments in our conversation came when Ms. Cabraser, who represented plaintiffs in the silicone litigation, complained that Daubert was unfair because corporate defendants were able to order up supporting scientific studies, whereas poor plaintiffs counsel did not have the means to gin up studies that confirmed what they knew to be true.2 Refraining from talking over her required all the self-restraint I could muster, but I did eventually respond by denying her glib generalization and offering the silicone litigation as one in which plaintiffs, plaintiffs’ counsel, and plaintiffs’ support groups were all involved in funding and directing some of the sketchiest studies, most of which managed to find homes in so-called peer-reviewed journals of some sort, even if not the best.

The litigation connections of the plaintiff-sponsored studies in the silicone litigation were not apparent on the face of the published articles. The partisan funding and provenance of the studies were mostly undisclosed and required persistent discovery and subpoenas. Cabraser’s propaganda reinforced the recognition of what so-called mass tort litigation had taught me about all scientific studies: “trust but verify.” Verification is especially important for studies that are sponsored by litigation-industry actors who have no reputation at stake in the world of healthcare.

Verification is not a straightforward task, however. Peer-review publication usually provides some basic information about “methods and materials,” but rarely if ever do published articles provide sufficient data and detail about methodology to replicate the reported analysis. In legal proceedings, verification of studies conducted and relied upon by testifying expert witnesses is facilitated by the rules of expert witness discovery. In federal court, expert witnesses must specify all opinions and all bases for their opinions. When such witnesses rely upon their own studies, and thus have had privileged access to the complete data and all analyses, courts have generally permitted full inquiry into the underlying materials of relied-upon studies. On the other, when the author of a relied-upon study is a “stranger to the litigation,” neither a party nor a retained expert witness, courts have permitted generally more limited discovery of the study’s full data set and analyses. Regardless of the author’s status, the question remains how litigants are to challenge an adversary’s expert witness’s trusted reliance upon a study, which cannot be “verified.”

Most lawyers would prefer, of course, to call an expert witness who has actually conducted studies pertinent to the issues in the case. The price, however, of allowing the other side to discover the underlying data and materials of the author expert witness’s studies may be too high. The relied-upon studies may well end up discredited, as well as the professional reputation of the expert witness. The litigation industry has adapted to these rules of discovery by avoiding, in most instances, calling testifying expert witnesses who have published studies that might be vulnerable.3

One work-around to the discovery rules lies in the use of “consulting, non-testifying expert witnesses.” The law permits the use of such expert witnesses to some extent to facilitate candid consultations with expert witnesses, usually without concerns that communications will be shared with the adversary party and witnesses. The hope is that such candid communications will permit realistic assessment of partisan positions, as well as allowing scientists and scholars to participate in an advisory capacity without the burden of depositions, formal report writing, and appearances at judicial hearings and trials. The confidentiality of consulting expert witnesses is open to abuse by counsel who would engage the consultants to conduct and publish studies, which can then be relied upon by the testifying expert witnesses. The upshot is that legal counsel can manipulate the published literature in a favorable way, without having to disclose their financial sponsorship or influence of the published studies used by their testifying expert witnesses.

This game of hiding study data and sponsorship through the litigation industry’s use of confidential consulting expert witnesses pervades so-called mass tort litigation, which provides ample financial incentives for study sponsorship and control. Defendants will almost always be unable to play the game, without detection. A simple interrogatory or other discovery request about funding of studies will reveal the attempt to pass off a party-sponsored study as having been conducted by disinterested scientists. Furthermore, most scientists will feel obligated to reveal corporate funding as a potential conflict of interest, in their submission of manuscripts for publication.

Revealing litigation-industry (plaintiffs’) funding of studies is more complicated. First, the funding may be through one firm, which is not the legal counsel in the case for which discovery is being conducted. In such instances, the plaintiff’s lawyers can truthfully declare that they lack personal knowledge of any financial support for studies relied upon by their testifying expert witnesses. Second, the plaintiffs’ lawyer firm is not a party is not itself subject to discovery. Even if the plaintiffs’ lawyers funded a study, they can claim, with plausible deniability, that they funded the study in connection with another client’s case, not the client who is plaintiff in the case in which discovery is sought. Third, the plaintiffs’ firm may take the position, however dubious it might be, that the funding of the relied-upon study was simply a confidential consultation with the authors of that study, and not subject to discovery.

The now pending litigation against ondansetron (Zofran) provides the most recent example of the dubious use of consulting expert witnesses to hide party sponsorship of an epidemiologic study. The plaintiffs, who are claiming that Zofran causes birth defects in this multi-district litigation assigned to Judge F. Dennis Saylor, have designated Dr. Carol Luik as their sole testifying expert witness on epidemiology. Dr. Luik, in turn, has relied substantially upon a study conducted by Dr. April Zambelli-Weiner.4

According to motion papers filed by defendants,5 the plaintiffs’ counsel initially claimed that they had no knowledge of any financial support or conflicts for Dr Zambelli-Weiner. The conflict-of-interest disclosure in Zambelli-Weiner’s paper was, to say the least, suspicious:

“The authors declare that there was no outside involvement in study design; in the collection, analysis and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.”

As an organization TTi reports receiving funds from plaintiff law firms involved in ondansetron litigation and a manufacturer of ondansetron.”

According to its website, TTi

“is an economically disadvantaged woman-owned small business headquartered in Westminster, Maryland. We are focused on the development, evaluation, and implementation of technologies and solutions that advance the transformation of data into actionable knowledge. TTi serves a diverse clientele, including all stakeholders in the health space (governments, payors, providers, pharmaceutical and device companies, and foundations) who have a vested interest in advancing research to improve patient outcomes, population health, and access to care while reducing costs and eliminating health disparities.”

According to defendants’ briefing, and contrary to plaintiffs’ initial claims and Zambelli-Weiner’s anemic conflicts disclosure, plaintiffs’ counsel eventually admitted that “Plaintiffs’ Leadership Attorneys paid $210,000 as financial support relating to” Zambelli-Weiner’s epidemiologic study. The women at TTi are apparently less economically disadvantaged than advertised.

The Zofran defendants served subpoenas duces tecum and ad testificandum on two of the study authors, Drs. April Zambelli-Weiner and Russell Kirby. Curiously, the plaintiffs (who would seem to have no interest in defending the third-party subpoenas) sought a protective order by arguing that defendants were harassing “third-party scientists.” Their motion for protection conveniently and disingenuously omitted, that Zambelli-Weiner had been a paid consultant to the Zofran plaintiffs.

Judge Saylor refused to quash the subpoenas, and Zambelli-Weiner appeared herself, through counsel, to seek a protective order. Her supporting affidavit averred that she had not been retained as an expert witness, and that she had no documents “concerning any data analyses or results that were not reported in the [published study].” Zambelli-Weiner’s attempt to evade discovery was embarrassed by her having presented a “Zofran Litigation Update” with Plaintiffs’ counsel Robert Jenner and Elizabeth Graham at a national conference for plaintiffs’ attorneys. Judge Saylor was not persuaded, and the MDL court refused Dr. Zambelli-Weiner’s motion. The law and the public has a right to every man’s, and every woman’s, (even if economically disadvantaged) evidence.6

Tellingly, in the aftermath of the motions to quash, Zambelli-Weiner’s counsel, Scott Marder, abandoned his client by filing an emergency motion to withdraw, because “certain of the factual assertions in Dr. Zambelli-Weiner’s Motion for Protective Order and Affidavit were inaccurate.” Mr. Marder also honorably notified defense counsel that he could no longer represent that Zambelli-Weiner’s document production was complete.

Early this year, on January 29, 2019, Zambelli-Weiner submitted, through new counsel, a “Supplemental Affidavit,” wherein she admitted she had been a “consulting expert” witness for the law firm of Grant & Eisenhofer on the claimed teratogenicity of Zofran.7 Zambelli-Weiner also produced a few extensively redacted documents. On February 1, 2019, Zambelli-Weiner testified at deposition that the moneys she received from Grant & Eisenhofer were not to fund her Zofran study, but for other, “unrelated work.” Her testimony was at odds with the plaintiffs’ counsel’s confession that the $210,000 related to her Zofran study.

Zambelli-Weiner’s etiolated document production was confounded by the several hundred of pages of documents produced by fellow author, Dr. Russell Kirby. When confronted with documents from Kirby’s production, Zambelli-Weiner’s lawyer unilaterally suspended the deposition.

Deja Vu All Over Again

Federal courts have seen the Zambelli maneuver before. In litigation over claimed welding fume health effects, plaintiffs’ counsel Richard (Dickie) Scruggs and colleagues funded some neurological researchers to travel to Alabama and Mississippi to “screen” plaintiffs and potential plaintiffs in litigation for over claims of neurological injury and disease from welding fume exposure, with a novel videotaping methodology. The plaintiffs’ lawyers rounded up the research subjects (a.k.a. clients and potential clients), talked to them before the medical evaluations, and administered the study questionnaires. The study subjects were clearly aware of Mr. Scruggs’ “research” hypothesis, and had already promised him 40% of any recovery.8

After their sojourn, at Scruggs’ expense to Alabama and Mississippi, the researchers wrote up their results, with little or no detail of the circumstances of how they had acquired their research “participants,” or those participants’ motives to give accurate or inaccurate medical and employment history information.9

Defense counsel served subpoenas upon both Dr. Racette and his institution, Washington University St. Louis, for the study protocol, underlying data, data codes, and all statistical analyses. Racette and Washington University resisted sharing their data and materials with every page in the Directory of Non-Transparent Research. They claimed that the subpoenas sought production of testimony, information and documents in violation of:

“(1) the Federal Regulations set forth in the Department of Health and Human Services Policy for Protection of Human Research Subjects,

(2) the Federal regulations set forth in the HIPPA Regulations,

(3) the physician/patient privilege,

(4) the research scholar’s privilege,

(5) the trade secret/confidential research privilege and

(6) the scope of discovery as codified by the Federal Rules of Civil Procedure and the Missouri Rules of Civil Procedure.”

After a long discovery fight, the MDL court largely enforced the subpoenas.10 The welding MDL court ordered Racette to produce

“a ‘limited data set’ which links the specific categories requested by defendants: diagnosis, occupation, and age. This information may be produced as a ‘deidentified’ data set, such that the categories would be linked to each particular patient, without using any individual patient identifiers. This data set should: (1) allow matching of each study participant’s occupational status and age with his or her neurological condition, as diagnosed by the study’s researchers; and (2) to the greatest extent possible (except for necessary de-identification), show original coding and any code-keys.”

After the defense had the opportunity to obtain and analyze the underlying data in the Scruggs-Racette study, the welding plaintiffs retreated from their epidemiologic case. Various defense expert witnesses analyzed the underlying data produced by Racette, and prepared devastating rebuttal reports. These reports were served upon plaintiffs’ counsel, whose expert witnesses never attempted any response. Reliance upon Racette’s study was withdrawn or abandoned. After the underlying data were shared with the parties to MDL 1535, no scientist appeared to defend the results in the published papers.11 The Racette Alabama study faded into the background of the subsequent welding-fume cases and trials.

The motion battle in the welding MDL revealed interesting contradictions, similar to those seen in the Zambelli-Weiner affair. For example, Racette claimed he had no relationship whatsoever with plaintiffs’ counsel, other than showing up by happenstance in Alabama at places where Scruggs’ clients also just happened to show up. Racette claimed that the men and women he screened were his patients, but he had no license to practice in Alabama, where the screenings took place. Plaintiffs’ counsel disclaimed that Racette was a treating physician, which acknowledgment would have made the individual’s screening results discoverable in their individual cases. And more interestingly, plaintiffs’ counsel claimed that both Dr. Racette and Washington University were “non-testifying, consulting experts utilized to advise and assist Plaintiffs’ counsel with respect to evaluating and assessing each of their client’s potential lawsuit or claim (or not).”12

Over the last decade or so, best practices and codes of conduct for the relationship between pharmacoepidemiologists and study funders have been published.13 These standards apply with equal force to public agencies, private industry, and regulatory authories. Perhaps it is time for them to specify that the apply to the litigation industry as well.

1 See Smith v. Wyeth-Ayerst Labs. Co., 278 F. Supp. 2d 684, 710 & n. 56 (W.D.N.C. 2003).

2 Ironically, Ms. Cabraser has published her opinion that failure to disclose conflicts of interest and study funding should result in evidentiary exclusions, a view which would have simplified and greatly shortened the silicone gel breast implant litigation. See 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).

3 Litigation concerning Viagra is one notable example where plaintiffs’ counsel called an expert witness who was the author of the very study that supposedly supported their causal claim. It did not go well for the plaintiffs or the expert witness. See Lori B. Leskin & Bert L. Slonim, “A Primer on Challenging Peer-Reviewed Scientific Literature in Mass Tort and Product Liability Actions,” 25 Toxics L. Rptr. 651 (Jul. 1, 2010).

4 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).

5 Nate Raymond, “GSK accuses Zofran plaintiffs’ law firms of funding academic study,” Reuters (Mar. 5, 2019).

6 See Branzburg v. Hayes, 408 U.S. 665, 674 (1972).

7 Affidavit of April Zambelli-Weiner, dated January 9, 2019 (Doc. No. 1272).

8 The plaintiffs’ lawyers’ motive and opportunity to poison the study by coaching their “clients” was palpable. See David B. Resnik & David J. McCann, “Deception by Research Participants,” 373 New Engl. J. Med. 1192 (2015).

9 See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, J.S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005); Brad A. Racette, et al., “A rapid method for mass screening for parkinsonism,” 27 Neurotoxicology 357 (2006) (a largely duplicative report of the Alabama welders study).

10 See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Oct. 18, 2005) (upholding defendants’ subpoena for protocol, data, data codes, statistical analyses, and other things from Dr. Racette’s Alabama study on welding and parkinsonism).

11 Racette sought and obtained a protective order for the data produced, and thus I still cannot share the materials he provided asking that any reviewer sign the court-mandated protective order. Revealingly, Racette was concerned about who had seen his underlying data, and he obtained a requirement in the court’s non-disclosure affidavit that any one who reviews the underlying data will not sit on peer review of his publications or his grant applications. See Motion to Compel List of Defendants’ Reviewers of Data Produced by Brad A. Racette, M.D., and Washington University Pursuant to Protective Order, in In re Welding Fume Products Liab. Litig., MDL No. 1535, Case 1:03-cv-17000-KMO, Document 1642-1 (N.D. Ohio Feb. 14, 2006). Curiously, Racette never moved to compel a list of Plaintiffs’ Reviewers!

12 Plaintiffs’ Motion for Protective Order, Motion to Reconsider Order Requiring Disclovery from Dr. Racette, and Request for In Camera Inspection as to Any Responses or Information Provided by Dr. Racette, filed in Solis v. Lincoln Elec. Co., case No. 1:03-CV-17000, MDL 1535 (N.D. Ohio May 8, 2006).

13 See, e.g., Xavier Kurz, Susana Perez‐Gutthann, and 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 Pharmacoepidem. & Drug Safety 245 (2018).

Posted in Conflicts of Interest, Data Sharing, Expert Witness Discovery, Scientific Misconduct, Underlying Data | Comments Off on Litigation Science – In re Zambelli-Weiner

Castleman-Selikoff – Can Their Civil Conspiracy Survive Death?

December 4th, 2018

Several, years ago, I wrote about Barry Castleman’s 1979 memorandum to Irving Selikoff, in which Castleman implored Selikoff to refuse to cooperate with lawful discovery from defense counsel in asbestos personal injury cases. The Selikoff – Castleman Conspiracy” (Mar. 13, 2011). The document, titled “Defense Attorneys’ Efforts to Use Background Files of Selikoff-Hammond Studies to Avert Liability,” was dated November 5, 1979. Coming from The Legacy Tobacco Documents Library at the University of California, San Francisco, created by litigation industry’s tobacco subsidiary, the document is clearly authentic. Barry Castleman, however, has testified that he cannot remember the 35+ year old memorandum, which failure of recall is not probative of anything.1  He refuses to renounce his role as a co-conspirator.

Jock McCulloch and Geoffrey Tweedale have both made careers of attacking any manufacturing and mining industry with connections to asbestos, while supporting the litigation industry that thrives on asbestos. Sadly, Jock McCulloch died of mesothelioma, earlier this year, on January 18, 2018, in Australia. McCulloch attributed his disease to his exposure to crocidolite when he researched one of his books on blue asbestos in South Africa.2 Although I found his scholarship biased and exaggerated, I admired his tenacious zeal in pressing his claims. His candor about the cause of his last illness was exemplary compared with Selikoff’s failure to acknowledge the extent to which amosite and crocidolite were used in the United States.

In 2007, Jock McCulloch and Geoffrey Tweedale wrote an article in which they attacked those who dared to say anything negative about Irving Selikoff.3 Of course, in claiming that the asbestos industry was “shooting the messenger,” these authors were, well, shooting the messenger, too. In 2008, McCulloch and Tweedale wrote a much more interesting, hagiographic article about Selikoff.4 From the legal perpective, perhaps the most interesting revelation in this article was that the authors had drawn “upon unprecedented access to the Selikoff archive at Mount Sinai Hospital in New York City.”

Several years later, defense counsel in the United States attempted to visit the Selikoff archives at Mt. Sinai Hospital. After an unseemly delay, the inquisitive counsel were met with unprecedented obstruction and denial of access:

From: [ARCHIVIST]
To: [DEFENSE COUNSEL]
Subject: Request for appointment with Archivist
Date: Wed, 3 Sep 2014 16:18:53 +0000

I realize that this must seem out of the blue, but we have recently realized that the stub email address we have – msarchives – has not been forwarding email the way it was intended to do. I apologize for not responding to you previously, and for what it is worth, here is the answer to your question.

Some Selikoff material in the Mount Sinai Archives, although I believe some of his research material is still with our Dept. of Preventive Medicine. Our collection is currently closed to researchers, as per the request of Mount Sinai’s Legal Department in 2009. Here is their statement concerning these records:

It was agreed that Dr. Selikoff’s correspondence and archives that are kept within the auspices of the MSSM library under the direction of the MSSM archivist, Barbara Niss, would be kept confidential for at least an additional 25 years to protect Dr. Selikoff’s research endeavors and the privacy of all the individuals, particularly the research subjects, who he studied and with whom he communicated. It is anticipated that twenty-five years from now, these individuals will no longer be alive and their concerns about keeping these matters private will have become moot. However, if we determine that this is not the case, we will reserve the option to continue to keep these documents confidential. We are also taking this action to preserve the academic freedom of our researchers so they can pursue their research, communicate with colleagues and comment on these important environmental/scientific issues, without concerns that they will be subpoenaed as non-party witnesses in these massive tort litigations.

Again, my apologies for the very late reply. Please let me know if you have questions.

So there you have it, 35 years after Castleman implored Selikoff not to cooperate with lawyers’ proper fact discovery, the Selikoff archive is still at its obstruction and denial.

1 See “The Selikoff – Castleman Conspiracy” (Mar. 13, 2011). In 2014, Castleman testifies that he has no recollection of the memorandum. The document was also available at Scribd.

2 See Laurie Kazan-Allen, “In Memory of Jock McCulloch” (Jan. 21, 2018) (quoting an email from Jock McCulloch, dated July 21, 2017: “The injury almost certainly occurred while I was researching Asbestos Blues in South Africa, which is all of twenty years ago.”); “Remembering Jock McCulloch,” Toxic Docs Blog (Jan. 28, 2018) (quoting his partner’s tribute about the cause of his death: “His exposure to blue asbestos was probably in South Africa during the mid-1990s, when he was researching a book on the history of mining.”).

3 Jock McCulloch & Geoffrey Tweedale, “Shooting the Messenger: The Vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619 (2007).

4 Jock McCulloch and Geoffrey Tweedale, “Science is not Sufficient: Irving J. Selikoff and the Asbestos Tragedy,” 17 New Solutions 293 (2008).

Posted in Asbestos, Expert Witness Discovery, Historian Testimony | Comments Off on Castleman-Selikoff – Can Their Civil Conspiracy Survive Death?

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