TORTINI

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

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 alsoThe 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).

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.

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.).

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).