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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

Statistical Significance at the New England Journal of Medicine

July 19th, 2019

Some wild stuff has been going on in the world of statistics, at the American Statistical Association, and elsewhere. A very few obscure journals have declared p-values to be verboten, and presumably confidence intervals as well. The world of biomedical research has generally reacted more sanely, with authors defending the existing frequentist approaches and standards.[1]

This week, the editors of the New England Journal of Medicine have issued new statistical guidelines for authors. The Journal’s approach seems appropriately careful and conservative for the world of biomedical research. In an editorial introducing the new guidelines,[2] the Journal editors remind their potential authors that statistical significance and p-values are here to stay:

“Despite the difficulties they pose, P values continue to have an important role in medical research, and we do not believe that P values and significance tests should be eliminated altogether. A well-designed randomized or observational study will have a primary hypothesis and a prespecified method of analysis, and the significance level from that analysis is a reliable indicator of the extent to which the observed data contradict a null hypothesis of no association between an intervention or an exposure and a response. Clinicians and regulatory agencies must make decisions about which treatment to use or to allow to be marketed, and P values interpreted by reliably calculated thresholds subjected to appropriate adjustments have a role in those decisions.”[3]

The Journal’s editors described their revamped statistical policy as being based upon three premises:

(1) adhering to prespecified analysis plans if they exist;

(2) declaring associations or effects only for statistical analyses that have pre-specified “a method for controlling type I error”; and

(3) presenting evidence about clinical benefits or harms requires “both point estimates and their margins of error.”

With a hat tip to the ASA’s recent pronouncements on statistical significance,[4] the editors suggest that their new guidelines have moved away from bright-line applications of statistical significance “as a bright-line marker for a conclusion or a claim”[5]:

“[T]he notion that a treatment is effective for a particular outcome if P < 0.05 and ineffective if that threshold is not reached is a reductionist view of medicine that does not always reflect reality.”[6]

The editors’ language intimates greater latitude for authors in claiming associations or effects from their studies, but this latitude may well be circumscribed by tighter control over such claims in the inevitable context of multiple testing within a dataset.

The editors’ introduction of the new guidelines is not entirely coherent. The introductory editorial notes that the use of p-values for reporting multiple outcomes, without adjustments for multiplicity, inflates the number of findings with p-values less than 5%. The editors thus caution against “uncritical interpretation of multiple inferences,” which can be particularly threatening to valid inference when not all the comparisons conducted by the study investigators have been reported in their manuscript.[7] They reassuringly tell prospective authors that many methods are available to adjust for multiple comparisons, and can be used to control Type I error probability “when specified in the design of a study.”[8]

But what happens when such adjustment methods are not pre-specified in the study design? Failure to to do so do not appear to be disqualifying factors for publication in the Journal. For one thing, when the statistical analysis plan of the study has not specified adjustment methods for controlling type I error probabilities, then authors must replace p-values with “estimates of effects or association and 95% confidence intervals.”[9] It is hard to understand how this edict helps when the specified coefficient of 95% is a continuation of the 5% alpha, which would have been used in any event. The editors seem to be saying that if authors fail to pre-specify or even post-specify methods for controlling error probabilities, then they cannot declare statistical significance, or use p-values, but they can use confidence intervals in the same way they have been using them, and with the same misleading interpretations supplied by their readers.

More important, another price authors will have to pay for multiple testing without pre-specified methods of adjustment is that they will affirmatively have to announce their failure to adjust for multiplicity and that their putative associations “may not be reproducible.” Tepid as this concession is, it is better than previous practice, and perhaps it will become a badge of shame. The crucial question is whether judges, in exercising their gatekeeping responsibilities, will see these acknowledgements as disabling valid inferences from studies that carry this mandatory warning label.

The editors have not issued guidelines for the use of Bayesian statistical analyses, because “the large majority” of author manuscripts use only frequentist analyses.[10] The editors inform us that “[w]hen appropriate,” they will expand their guidelines to address Bayesian and other designs. Perhaps this expansion will be appropriate when Bayesian analysts establish a track record of abuse in their claiming of associations and effects.

The new guidelines themselves are not easy to find. The Journal has not published these guidelines as an article in their published issues, but has relegated them to a subsection of their website’s instructions to authors for new manuscripts:

https://www.nejm.org/author-center/new-manuscripts

Presumably, the actual author instructions control in any perceived discrepancy between this week’s editorial and the guidelines themselves. Authors are told that p-values generally should be two-sided. Authors’ use of:

“Significance tests should be accompanied by confidence intervals for estimated effect sizes, measures of association, or other parameters of interest. The confidence intervals should be adjusted to match any adjustment made to significance levels in the corresponding test.”

Similarly, the guidelines call for, but do not require, pre-specified methods of controlling family-wide error rates for multiple comparisons. For observational studies submitted without pre-specified methods of error control, the guidelines recommend the use of point estimates and 95% confidence intervals, with an explanation that the interval widths have not been adjusted for multiplicity, and a caveat that the inferences from these findings may not be reproducible. The guidelines recommend against using p-values for such results, but again, it is difficult to see why reporting the 95% confidence intervals is recommended when p-values are not recommended.

[1]  Jonathan A. Cook, Dean A. Fergusson, Ian Ford, Mithat Gonen, Jonathan Kimmelman, Edward L. Korn, and Colin B. Begg, “There is still a place for significance testing in clinical trials,” 16 Clin. Trials 223 (2019).

[2]  David Harrington, Ralph B. D’Agostino, Sr., Constantine Gatsonis, Joseph W. Hogan, David J. Hunter, Sharon-Lise T. Normand, Jeffrey M. Drazen, and Mary Beth Hamel, “New Guidelines for Statistical Reporting in the Journal,” 381 New Engl. J. Med. 285 (2019).

[3]  Id. at 286.

[4]  See id. (“Journal editors and statistical consultants have become increasingly concerned about the overuse and misinterpretation of significance testing and P values in the medical literature. Along with their strengths, P values are subject to inherent weaknesses, as summarized in recent publications from the American Statistical Association.”) (citing Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s statement on p-values: context, process, and purpose,” 70 Am. Stat. 129 (2016); Ronald L. Wasserstein, Allen L. Schirm, and Nicole A. Lazar, “Moving to a world beyond ‘p < 0.05’,” 73 Am. Stat. s1 (2019)).

[5]  Id. at 285.

[6]  Id. at 285-86.

[7]  Id. at 285.

[8]  Id., citing Alex Dmitrienko, Frank Bretz, Ajit C. Tamhane, Multiple testing problems in pharmaceutical statistics (2009); Alex Dmitrienko & Ralph B. D’Agostino, Sr., “Multiplicity considerations in clinical trials,” 378 New Engl. J. Med. 2115 (2018).

[9]  Id.

[10]  Id. at 286.

Posted in Scientific Evidence, statistical evidence | Comments Off on Statistical Significance at the New England Journal of Medicine

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

The Shmeta-Analysis in Paoli

July 11th, 2019

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

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

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

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

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

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

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

The Appeal

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

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

Validity

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

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

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

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

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

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

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

Peer Review

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

Relevancy Prong

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

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

Analysis

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

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

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

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

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

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

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

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

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

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

[5]  Id. at 373.

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

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

[8]  Id. at 845.

[9]  Id.

[10]  Id. at 841, 848.

[11]  Id. at 845.

[12]  Id. at 847-48.

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

[14]  Id. at 857.

[15]  Id. at 858/

[16]  Id. at 858.

[17]  Id. at 845.

[18]  Report, Table 16.

[19]  Report, Table 18.

[20]  In re Paoli, 916 F.2d at 847.

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

[22]  Report, Table 22.

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

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

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

California Roasts Fear-Mongering Industry

June 16th, 2019

A year ago, California set out to create an exemption for coffee from its Proposition 65 regulations. The lawsuit industry, represented by the Council for Education and Research on Toxics (CERT) had been successfully deploying Prop 65’s private right of action provisions to pick the pockets of coffee vendors. Something had to give.

In 2010, Mr. Metzger, on behalf of CERT, sued Starbucks and 90 other coffee manufacturers and distributors, claiming they had failed to warn consumers about the cancer risks of acrylamide. CERT’s mission was to shake down the roasters and the vendors because coffee has minor amounts of acrylamide in it. Acrylamide in very high doses causes tumors in rats[1]; coffee consumption by humans is generally regarded as beneficial.

Earlier last year a Los Angeles Superior Court ordered the coffee companies to put cancer warnings on their beverages. In the upcoming damages phase of the case, Metzger sought as much as $2,500 in civil penalties for each cup of coffee the defendants sold over at least a decade. Suing companies for violating California’s Proposition 65 is like shooting fish in a barrel, but the State’s regulatory initiative to save California from the embarrassment of branding coffee a carcinogen was a major setback for CERT.

And so the Office of Environmental Health Hazard Assessment (OEHHA) began a rulemaking largely designed to protect the agency from the public relations nightmare created by the application of the governing statute and regulations to squeeze the coffee roasters and makers.[2] The California’s agency’s proposed regulation on acrylamide in coffee resulted in a stay of CERT’s enforcement action against Starbucks.[3] CERT’s lawyers were not pleased; they had already won a trial court’s judgment that they were owed damages, and only the amount needed to be set. In September 2018, CERT filed a lawsuit in Los Angeles Superior Court against the state of California challenging OEHHA’s proposed rule, saying it was being rammed through the agency on the order of the Office of the Governor in an effort to kill CERT’s suit against the coffee companies. Or maybe it was simply designed to allow people to drink their coffee without the Big Prop 65 warning.

Earlier this month, after reviewing voluminous submissions and holding a hearing, the OEHHA announced its ruling that Californians do not need to be warned that coffee causes cancer. Epistemically, coffee is not known to the State of California to be hazardous to human health.[4] According to Sam Delson, a spokesperson for the OEHHA, “Coffee is a complex mixture of hundreds of chemicals that includes both carcinogens and anti-carcinogens. … The overall effect of coffee consumption is not associated with any significant cancer risk.” The regulation saving coffee goes into effect in October 2019. CERT, no doubt, will press on in its litigation campaign against the State.

CERT is the ethically dodgy organization founded by C. Sterling Wolfe, a former environmental lawyer; Brad Lunn; Carl Cranor, a philosophy professor at University of California Riverside; and Martyn T. Smith, a toxicology professor at University of California Berkeley.[5] Metzger has been its lawyer for many years; indeed, Metzger and CERT share the same office. Smith has been the recipient of CERT’s largesse in funding toxicologic studies. Cranor and Smith have both testified for the lawsuit industry.

In the well-known Milward case,[6] both Cranor and Smith served as paid expert witnesses for plaintiff. When the trial court excluded their proffered testimonies as unhelpful and unreliable, their own organization, CERT, came to the rescue by filing an amicus brief in the First Circuit. Supporting by a large cast of fellow travelers, CERT perverted the course of justice by failing to disclose the intimate relationship between the “amicus” CERT and the expert witnesses Cranor and Smith, whose opinions had been successfully challenged.[7]

The OEHHA coffee regulation shows that not all regulation is bad.

[1]  National Cancer Institute, “Acrylamide and Cancer Risk.”

[2]  See Sam Delson, “Press Release: Proposed OEHHA regulation clarifies that cancer warnings are not required for coffee under Proposition 65” (June 15, 2018).

[3]  Council for Education and Research on Toxics v. Starbucks Corp., case no. B292762, Court of Appeal of the State of California, Second Appellate District.

[4]  Associated Press, “Perk Up: California Says Coffee Cancer Risk Insignificant,” N.Y. Times (June 3, 2019); Sara Randazzo, “Coffee Doesn’t Warrant a Cancer Warning in California, Agency Says; Industry scores win following finding on chemical found in beverage,” W.S.J. (June 3, 2019); Editorial Board, “Coffee Doesn’t Kill After All: California has a moment of sanity, and a lawyer is furious,” Wall.St.J. (June 5, 2019).

[5]  Michael Waters, “The Secretive Non-Profit Gaming California’s Health Laws,” The Outline (June 18, 2018); Beth Mole, “The secretive nonprofit that made millions suing companies over cancer warnings,” Ars Technica (June 6, 2019); NAS, “Coffee with Cream, Sugar & a Dash of Acrylamide” (June 9, 2018); NAS, “The Council for Education & Research on Toxics” (July 9, 2013); NAS, “Sand in My Shoe – CERTainly” (June 17, 2014) (CERT briefs supported by fellow-travelers, testifying expert witnesses Jerrold Abraham, Richard W. Clapp, Ronald Crystal, David A. Eastmond, Arthur L. Frank, Robert J. Harrison, Ronald Melnick, Lee Newman, Stephen M. Rappaport, David Joseph Ross, and Janet Weiss, all without disclosing conflicts of interest).

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

[7]  NAS, “The Council for Education & Research on Toxics” (July 9, 2013) (CERT amicus brief filed without any disclosure of conflict of interest). The fellow travelers who knowingly or unknowingly aided CERT’s scheme to pervert the course of justice, included some well-known testifiers for the lawsuit industry: Nicholas A. Ashford, Nachman Brautbar, David C. Christiani, Richard W. Clapp, James Dahlgren, Devra Lee Davis, Malin Roy Dollinger, Brian G. Durie, David A. Eastmond, Arthur L. Frank, Frank H. Gardner, Peter L. Greenberg, Robert J. Harrison, Peter F. Infante, Philip J. Landrigan, Barry S. Levy, Melissa A. McDiarmid, Myron Mehlman, Ronald L. Melnick, Mark Nicas, David Ozonoff, Stephen M. Rappaport, David Rosner, Allan H. Smith, Daniel Thau Teitelbaum, Janet Weiss, and Luoping Zhang. See also NAS, “Carl Cranor’s Conflicted Jeremiad Against Daubert” (Sept. 23, 2018); Carl Cranor, “Milward v. Acuity Specialty Products: How the First Circuit Opened Courthouse Doors for Wronged Parties to Present Wider Range of Scientific Evidence” (July 25, 2011).

 

 

Posted in Causation, Public Nuisances, Toxicological Evidence | Comments Off on California Roasts Fear-Mongering Industry

Creators of ToxicDocs Show Off Their Biases

June 7th, 2019

Columbia Magazine’s most recent issue includes a laudatory story about David Rosner, a professor of history in Columbia University.1 The “story” focuses on Rosner’s website, ToxicDocs, which has become his and Gerald Markowitz’s clearing house for what they assert are industry’s misdeeds in the realm of public health.

What the magazine’s story chooses not to discuss is the provenance of the ToxicDocs website in Rosner and Markowitz’s long collaboration with the lawsuit industry in a variety of litigation endeavors. And what you will not find on ToxicDocs are documents of the many misdeeds of the sponsoring lawsuit industry’s misdeeds, such as unlawful and unethical screenings, evidentiary frauds, specious claiming, and misleading and incompetent medical advice to its clients. Nor will you find much in the way of context for the manufacturing industry’s documents.

Media coverage of ToxicDocs from last year provides some further insight into the provenance of the website.2 According one account, Rosner and Markowitz (collectively Rosnowitz) bristled when they were attacked for their litigation work by historian Philip Scranton, a professor in Rutgers University. Scranton showed that Rosnowitz were guilty of a variety of professional sins, from “overgeneralization and failure to corroborate” to “selectively appropriat[ing] information.” Although the radical left came to Rosnowitz’s defense by labeling Scranton a “hired gun,” that charge range rather hollow when Scranton was a well-regarded historian, and Rosnowitz were long-term hired guns for the lawsuit industry.3

And so these leftist historians felt the need to defend their long-term collaboration with the lawsuit industry by putting what they believed were incriminating documents on line at their website, ToxicDocs.4 The problem, however, with Rosnowitz’s response to the Scranton critique is that their website suffers from all the undue selectivity, lack of context, and bias, which afflict their courtroom work, and which validated Scranton’s report. Most important, the reader will not find anything on ToxicDocs that challenges the misdeeds of the lawsuit industry, which has employed them for so many years.

In February 2018, the Journal of Public Health Policy (vol. 39, no. 1) published a series of editorials lauding ToxicDocs.5 Remarkably, not a single paper by Rosnowitz, and their associates, Robert Proctor, David Wegman, or Anthony Robbins mentioned their service to the lawsuit industry or the extent of their income from that service. Sheldon Whitehouse wrote an editorial, in which he disclosed his having served as Rhode Island’s Attorney General, but failed to disclose that he had worked in lockstep with the plaintiffs’ firm, Motley Rice, and that he had hired Rosnowitz, in Rhode Island’s lawsuit against major paint manufacturers. For those observers who are in a moral panic over “industry” conflicts of interest, please note the conflicts of lawsuit industrial complex.

1 Carla Cantor, “ToxicDocs Exposes Industry Misdeeds” Columbia Magazine (Summer 2019).

2 Tik Root, “In ToxicDocs.org, a Treasure Trove of Industry Secrets,” Undark (Jan. 10, 2018).

3 See, e.g., Jon Wiener, “Cancer, Chemicals and History: Companies try to discredit the experts,” The Nation (Jan. 20, 2005).

4 See “ToxicHistorians Sponsor ToxicDocs” (Feb. 1, 2018); “David Rosner’s Document Repository” (July 23, 2017).

5 Anthony Robbins & Phyllis Freeman, “ToxicDocs (www.ToxicDocs.org) goes live: A giant step toward leveling the playing field for efforts to combat toxic exposures,” 39 J. Pub. Health Policy 1 (2018); David Rosner, Gerald Markowitz, and Merlin Chowkwanyun, “ToxicDocs (www.ToxicDocs.org): from history buried in stacks of paper to open, searchable archives online,” 39 J. Pub. Health Policy 4 (2018); Stéphane Horel, “Browsing a corporation’s mind,” 39 J. Pub. Health Policy 12 (2018); Christer Hogstedt & David H. Wegman, “ToxicDocs and the fight against biased public health science worldwide,” 39 J. Pub. Health Policy 15 (2018); Joch McCulloch, “Archival sources on asbestos and silicosis in Southern Africa and Australia,” 39 J. Pub. Health Policy 18 (2018); Sheldon Whitehouse, “ToxicDocs: using the US legal system to confront industries’ systematic counterattacks against public health,” 39 J. Pub. Health Policy 22 (2018); Robert N. Proctor, “God is watching: history in the age of near-infinite digital archives,” 39 J. Pub. Health Policy 24 (2018); Elena N. Naumova, “The value of not being lost in our digital world,” 39 J. Pub. Health Policy 27 (2018); Nicholas Freudenberg, “ToxicDocs: a new resource for assessing the impact of corporate practices on health,” 39 J. Pub. Health Policy 30 (2018).

Posted in Conflicts of Interest, Expert Witnesses, Historian Testimony | Comments Off on Creators of ToxicDocs Show Off Their Biases

Sophisticated Intermediary Defense in Asbestos Cases – Use With Discretion

May 20th, 2019

“Discretion is the better part of valor.” Shakespeare, King Henry the Fourth.

A recent asbestos case illustrates the perils of improvidently asserting a sophisticated intermediary defense, when the alleged injury is mesothelioma, and the years of exposure reach back to the 1940s. In Sawyer v. Union Carbide Corp., Foster Wheeler LLC, pleaded sophisticated intermediary and superseding cause defenses “pro forma,” in a mesothelioma case that involved asbestos exposure from 1948 through the 1970s.[1] Plaintiff moved for partial summary judgment on these two defenses, but rather than withdraw the defenses, Foster Wheeler attempted to present evidentiary support in the form of the employer’s (purchaser’s) knowledge of asbestos hazards. The employer was the Bethlehem Steel Company, at the Bethlehem Steel Sparrows Point Shipyard.

Foster Wheeler certainly was able to show that Bethlehem Steel was aware of the hazards of asbestosis, going back to 1948. If the plaintiff’s alleged injury had been asbestosis, the employer’s knowledge should have sufficed. The injury alleged, however, was mesothelioma. Evidence that the Maritime Commission had warned Bethlehem Steel about the hazards of asbestosis, and to maintain a threshold limit value of 5 million particles per cubic foot, was not particularly germane or helpful in avoiding mesothelioma among employees.

Moving forward two decades, Foster Wheeler was able to show that Bethlehem Steel’s Medical Director, Dr. Paul J. Whitaker, was well aware of the connection between asbestos exposure and mesothelioma, in 1968.[2] This evidence, however, left two decades of exposure, from 1948 to 1968, in which Foster Wheeler had not shown its purchaser was aware of the risk of mesothelioma.

The trial court in Sawyer, however, did not focus on the differential between an asbestosis and a mesothelioma hazard. Instead of noting the lack of knowledge with respect to mesothelioma, the trial court insisted that the supplier must have subjective awareness of the purchaser’s actual knowledge of the relevant hazards. Even the overwhelming evidence of Bethlehem’s awareness of asbestosis hazards throughout the plaintiff’s employment was thus, questionably, deemed irrelevant.

According the trial court, the sophisticated intermediary defense focuses on what “focuses on what the product manufacturer knew and the reasonableness of its reliance on the employer prior to and during the time the workers were exposed.”[3] The Sawyer court took this focus to require a showing that the defendant had actual awareness of the intermediary’s knowledge of the dangers of asbestos exposure. According to the decision, Foster Wheeler failed to establish a basis for having such actual knowledge of Bethlehem Steel’s knowledge.

The Sawyer court’s insistence upon actual awareness is not supported by its citation to the Restatement (Second) of Torts. The relevant provision for sales of products to be used by a third party states that[4]:

“One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier

  • knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and
  • has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and
  • fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous.”

The Restatement’s articulated standard does not call for the seller’s subjective awareness as a necessary condition. Having a reason to believe the user will realize its dangerous condition seems eminently satisfied by a generalized, reasonable belief that purchasers are sophisticated with respect to the product’s use. Foster Wheeler might have improved its evidentiary showing in opposition to plaintiff’s motion, however, by adverting to its own knowledge that there was a prevalent regulatory scheme, including the Walsh-Healy Act, which covered the safety of workers in the use of asbestos. As noted above, this knowledge would not have implicated the hazard of mesothelioma or the means to avoid it in purchasers’ workplaces.

The Sawyer decision offered virtually no support for the proposition that the seller, wishing to avail itself of the sophisticated intermediary defense, must have actual knowledge of the buyer’s awareness of the relevant hazard. Failure to warn liability for a product’s harm is predicated upon negligence law. Almost all civilized jurisdictions require plaintiff to show negligence in such cases.[5] The test for non-obviousness such that a warning might be required under the law is an objective one, which does not turn on the user’s actual knowledge of the hazard.[6]

Although standing on the sophisticated intermediary defense may have been improvident in Sawyer, there are many cases that cry out for dismissal on the strength of the defense. The facts of silica cases, for example, are radically different from early exposure asbestos cases because of the wide diffusion and general equality of knowledge of silica hazards throughout industry, labor, and government.[7]  The dangers of occupational exposure to crystalline silica were so well known that the New York Court of Appeals recognized, seventy years ago, that “[i]t is a matter of common knowledge that it is injurious to the lungs and dangerous to health to work in silica dust.”[8] This pervasiveness of knowledge about the potential hazards of industrial silica exposure has been the basis for many dispositive rulings in silica cases, even when the sellers lacked subjective awareness of the buyer’s state of mind.[9]

Product liability is defined and bounded by the scope of an essential need for warnings in the face of imbalances in knowledge between seller and buyer. When the rationale is not or cannot be satisfied, ignoring the sophisticated intermediary’s knowledge is little more than creating a “duty to pay.” In the context of industrial sales of materials and products to large, sophisticated buyers, the law recognizes that warnings are often unnecessary and even counter-productive when hazards of the materials or products are known to the buyers as well as, if not better than, to the sellers. The so-called sophisticated intermediary defense thus reflects nothing more than the rational limits of liability in situations when the chattel is widely known to be hazardous, and the seller can reasonably rely upon the intermediary to be aware of the hazard and to protect down-stream users, typically employees of the purchaser.

Because of the shift in knowledge about the causal relationship between amphibole asbestos and mesothelioma, asbestos product cases would appear unlikely applications for sophisticated intermediary defenses, at least until the knowledge of mesothelioma hazards became widely prevalent. Because of the  change in the state of the art with respect to asbestos hazards, asbestos cases involve substantial factual and legal differences from other hazardous material cases. The singular facts of some of the asbestos cases include an extreme imbalance between supplier and some purchasers in their respective knowledge of asbestos hazards. Accordingly, jurisdictions that have embraced the sophisticated intermediary defense have thus treated asbestos cases, with pre-OSHA exposures, differently from other occupational exposure cases.[10]

The OSH Act of 1970, which created OSHA, was fueled in large part by wide-spread awareness and concern about asbestos exposure and occupational cancers, such as mesothelioma. In asbestos cases involving only post-1969 asbestos exposures, courts have upheld the applicability of the sophisticated intermediary defense. Thus a federal trial court in Kentucky, applying Indiana law, granted summary judgment to a respirator manufacturer, on the basis of the sophisticated intermediary defense, in a post-OSHA asbestos lung cancer case.[11] Similarly, a Virginia state trial court, notwithstanding the application of Virginia law in the Willis and Oman federal cases upheld the sophisticated intermediary defense as a complete legal defense for asbestos sales after 1970.[12] The decisions in these asbestos cases with only post-1970 asbestos exposure emphasized the equality of knowledge of asbestos hazards, which distinguished them from earlier asbestos cases involving companies such as Johns-Manville, which had been found to suppress or hide information from purchasers and workers.[13]

[1] Sawyer v. Union Carbide Corp., Civil No. CCB-16-118, 2019 U.S. Dist. LEXIS 72215 at *33; 2019 WL 1904882 (D. Md. April 29, 2019).

[2] Sawyer at *36.

[3] Sawyer at *36 (quoting Willis v. Raymark Indus., Inc., 905 F.2d 793, 797 (4th Cir. 1990)).

[4]  § 388 Chattel Known to Be Dangerous for Intended Use, Restatement (Second) of Torts (1965).

[5] Under New York law, for instance, the duty to warn in strict liability is identical in nature and scope as the duty in negligence. Martin v. Hacker, 83 N.Y. 1, 8 n.1 (1993). New York law acknowledges that there is no meaningful distinction between negligent and strict liability failure to warn claims. See Fane v. Zimmer, Inc., 927 F.2d 124, 130 (2d Cir. 1991) (New York law) (“Failure to warn claims purporting to sound in strict liability and those sounding in negligence are essentially the same.”). See also Rainbow v. Albert Elia Bldg. Co., 49 A.D.2d 250 (4th Dept. 1974) (distinguishing manufacturing and design defects, and permitting “reasonableness” defenses, including state-of-the-art defenses, to the latter in strict products liability), aff’d, 56 N.Y.2d 550 (1981). On the equivalence between negligence and product liability for failure to warn, New York law is aligned with the law of most states. See Restatement (Third) of Torts: Products Liability § 2, and comment I (1998); Restatement (Second) of Torts § 388 & comment n (1965); Restatement (First) of Torts § 388, comment 1 (1934).

[6] The standard for the open and obvious defense, which is many respects is a variant of the sophisticated intermediary defense, is an objective one, based on what would be obvious to the ordinary person. See Plante v. Hobart Corp., 771 F.2d 617, 620 (1st Cir. 1985) (“Where the danger involved in using a product is obvious and apparent, discernible by casual inspection, a supplier is not negligent in failing to warn of that danger.”); Fleck v. KDI Sylvan Pools, Inc., 981 F.2d 107, 119 (3d Cir. 1992) (“[W]hether a danger is open and obvious is an objective inquiry, not dependent upon the actual knowledge of the user or his actual awareness of the danger.”); Glittenberg v. Doughboy, 491 N.W.2d 208, 213 (Mich. 1992) (“Determination of the ‘obvious’ character of a product- connected danger is objective.”).

[7] See Linda Regis, “Frame the Sandbox to Sandblasting: Regulation of Crystalline Silica,” 17 Pace Envt’l L. Rev. 207, 208 n. 8 (1999); Richard Ausness, “Learned Intermediaries and Sophisticated Users: Encouraging the Use of Intermediaries to Transmit Product Safety Information,” 46 Syracuse L. Rev. 1185, 1205-07 (1996); Kenneth Willner, “Failures to Warn and the Sophisticated User Defense,” 74 Va. L. Rev. 579 (1988); Victor Schwartz & Russell Driver, “Warnings in the Workplace: The Need for a Synthesis of Law and Communication Theory,” 52 U. Cin. L. Rev. 38 (1983).

[8] Sadowski v. Long Island RR., 292 N.Y. 448, 456 (1944) (emphasis added). A few years later, the United States Supreme Court concurred and quoted Sadowski. Urie v. Tompkins, 337 U.S. 163, 190 (1949).

[9] See, e.g., Goodbar v. Whitehead Bros., 591 F. Supp. 552 (W.D. Va. 1984), aff’d sub nom. Beale v. Hardy, 769 F.2d 213 (4th Cir. 1985); Smith v. Walter C. Best, Inc., 927 F.2d 736 (3d Cir. 1990) (applying Ohio law in a silica foundry case); Bergfeld v. Unimin Corp., 319 F.3d 350 (8th Cir. 2003) (applying Iowa law to affirm summary judgment); Haase v. Badger Mining Corp., 266 Wis. 2d 970 (Wis. Ct. App. 2003), aff’d, 274 Wis. 2d 143 (2004); Damond v. Avondale Industries, 718 So. 2d 551 (La. App. 1998) (affirming summary judgment for a silica supplier on a worker’s claims for silicosis from sandblasting, which if not done carefully, can be an extremely hazardous); Cowart v. Avondale Indus., 792 So. 2d 73 (La. Ct. App. 2001) (holding that the sophisticated user defense was dispositive in a foundry workplace, which was sophisticated about the potential hazards of its silica use); Bates v. E.D. Bullard Co., 76 So.3d 111 (La.App. 2011) (affirming summary judgment for silica suppliers); Phillips v. A.P. Green Refractories Co., 428 Pa. Super. 167, 630 A.2d 874 (1993), aff’d on other grounds, Phillips v. A-Best Products Co., 542 Pa. 124, 665 A.2d 1167 (1995) (lack of proximate cause for claimed failure to warn).

[10] Virginia law, which governed the Willis case cited by the Sawyer court is illustrative. Compare Oman v. Johns-Manville Corp., 764 F.2d 224 (4th Cir. 1985) (applying Virginia law, which embraces § 388, but refusing to apply the doctrine because the employer was unaware of asbestos hazards during plaintiffs’ employment before 1964), cert. denied sub nom. Oman v. H.K. Porter, 474 U.S. 970 (1985), with Beale v. Hardy, 469 F.2d 213 (4th Cir. 1985) (holding that Section 388 was a complete defense in silicosis cases under Virginia law). Michigan, another industrialized state with well-developed case law, also illustrates the disparate treatment of asbestos cases. Compare Russo v. Abex Corp., 670 F. Supp. 206, 208 (E.D. Mich. 1987) (holding that “asbestos-containing product manufacturers have an absolute duty to warn because of the unique and patent dangers of asbestos”) with Jodway v. Kennametal, Inc., 207 Mich. App. 622, 525 N.W.2d 883 (Mich. Ct. App. 1994) (applying Section 388 in hard-metal (cobalt) lung disease case); Kudzia v. Carboloy Division, 190 Mich. App. 285, 475N.W.2d 371 (1991) (same), aff’d, 439 Mich. 923, 479 N.W.2d 679 (1992); Tasca v. GTE Products Corp., 175 Mich. App. 617, 438 N.W.2d 625 (Mich. Ct. of App. 1989) (same). See also Antcliff v. State Employees Credit Union, 414 Mich. 624, 640 (1982); Ross v. Jaybird Automation, Inc., 172 Mich. App. 603, 607 (1988); Rasmussen v. Louisville Ladder Co., Inc., 211 Mich. App. 541, 547-48 (1995); Portelli v. I.R. Construction Products Co., 218 Mich. App. 591, 599 (1996); Mills v. Curioni, 238 F. Supp. 876, 894-96 (E.D. Mich. 2002).

[11] Triplett v. Minnesota Mining & Mfg. Co., 422 F. Supp. 2d 779 (W.D. Ky. 2006).

[12] Bean v. Asbestos Corporation, Ltd., 1998 WL 972122 (Va. Cir. Ct. 1998).

[13] See also Gottschall v. General Electric Co., 2011 U.S. Dist. LEXIS 151563 (E.D. Pa. Dec. 8, 2011) (MDL 875) (California law; granting summary judgment when the Navy’s knowledge of asbestos hazards was equal to that of defendant), rev’d, No. 14-15379, 14-15380, 2016 U.S. App. LEXIS 17248 (9th Cir. 2016).

Posted in Asbestos, Learned and sophisticated intermediary, Sophisticated User | Comments Off on Sophisticated Intermediary Defense in Asbestos Cases – Use With Discretion

Specious Claiming in Multi-District Litigation

May 2nd, 2019

In a recent article in an American Bar Association newsletter, Paul Rheingold notes with some concern that, in the last two years or so, there has been a rash of dismissals of entire multi-district litigations (MDLs) based upon plaintiffs’ failure to produce expert witnesses who can survive Rule 702 gatekeeping.[1]  Paul D. Rheingold, “Multidistrict Litigation Mass Terminations for Failure to Prove Causation,” A.B.A. Mass Tort Litig. Newsletter (April 24, 2019) [cited as Rheingold]. According to Rheingold, judges historically involved in the MDL processing of products liability cases did not grant summary judgments across the board. In other words, federal judges felt that if plaintiffs’ lawyers aggregated a sufficient number of cases, then their judicial responsibility was to push settlements or to remand the cases to the transferor courts for trial.

Missing from Rheingold’s account is the prevalent judicial view, in the early going of MDL of products cases, which held that judges lacked the authority to consider Rule 702 motions for all cases in the MDL. Gatekeeping motions were considered extreme and best avoided by pushing them off to the transferor courts upon remand. In MDL 926, involving silicone gel breast implants, the late Judge Sam Pointer, who was a member of the Rules Advisory Committee, expressed the view that Rule 702 gatekeeping was a trial court function, for the trial judge who received the case on remand from the MDL.[2] Judge Pointer’s view was a commonplace in the 1990s. As mass tort litigation moved into MDL “camps,” judges more frequently adopted a managerial rather than a judicial role, and exerted great pressure on the parties, and the defense in particular, to settle cases. These judges frequently expressed their view that the two sides so stridently disagreed on causation that the truth must be somewhere in between, and even with “a little causation,” the defendants should offer a little compensation. These litigation managers thus eschewed dispositive motion practice, or gave it short shrift.

Rheingold cites five recent MDL terminations based upon “Daubert failure,” and he acknowledges other MDLs collapsed because of federal pre-emption issues (Eliquis, Incretins, and possibly Fosamax), and that other fatally weak causal MDL claims settled for nominal compensation (NuvaRing). He omits other MDLs, such as In re Silica, in which an entire MDL collapsed because of prevalent fraud in the screening and diagnosing of silicosis claimants by plaintiffs’ counsel and their expert witnesses.[3] Also absent from his reckoning is the collapse of MDL cases against Celebrex[4] and Viagra[5].

Rheingold does concede that the recent across-the-board dismissals of MDLs were due to very weak causal claims.[6] He softens his judgment by suggesting that the weaknesses were apparent “at least in retrospect,” but the weaknesses were clearly discernible before litigation by the refusal of regulatory agencies, such as the FDA, to accept the litigation-driven causal claims. Rheingold also tries to assuage fellow plaintiffs’ counsel by suggesting that plaintiffs’ lawyers somehow fell prey to the pressure to file cases because of internet advertising and the encouragement of records collection and analysis firms. This attribution of naiveté to Plaintiffs’ Steering Committee (PSC) members does not ring true given the wealth and resources of lawyers on PSCs. Furthermore, the suggestion that PSC member may be newcomers to the MDL playing fields does not hold water given that most of the lawyers involved are “repeat players,” with substantial experience and financial incentives to sort out invalid expert witness opinions.[7]

Rheingold offers the wise counsel that plaintiffs’ lawyers “should take [their] time and investigate for [themselves] the potential proof available for causation and adequacy of labeling.” If history is any guide, his advice will not be followed.

[1] Rheingold cites five MDLs that were “Daubert failures” in the recent times: (1) In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Prods. Liab.  Litig. (MDL 2502), 892 F.3d 624 (4th Cir. 2018) (affirming Rule 702 dismissal of claims that atorvastatin use caused diabetes); (2) In re Mirena IUD Products Liab. Litig. (Mirena II, MDL 2767), 713 F. App’x 11 (2d Cir. 2017) (excluding expert witnesses’ opinion testimony that the intrauterine device caused embedment and perforation); (3) In re Mirena Ius Levonorgestrel-Related Prods. Liab. Litig., (Mirena II), 341 F. Supp. 3d 213 (S.D.N.Y. 2018) (affirming Rule 702 dismissal of claims that product caused pseudotumor cerebri); (4) In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 858 F.3d 787 (3d Cir. 2017) (affirming MDL trial court’s Rule 702 exclusions of opinions that Zoloft is teratogenic); (5) Jones v. SmithKline Beecham, 652 F. App’x 848 (11th Cir. 2016) (affirming MDL court’s Rule 702 exclusions of expert witness opinions that denture adhesive creams caused metal deficiencies).

[2]  Not only was Judge Pointer a member of the Rules committee, he was the principal author of the 1993 Amendments to the Federal Rules of Civil Procedure, as well as the editor-in-chief of the Federal Judicial Center’s Manual for Complex. At an ALI-ABA conference in 1997, Judge Pointer complained about the burden of gatekeeping. 3 Federal Discovery News 1 (Aug. 1997). He further opined that, under Rule 104(a), he could “look to decisions from the Southern District of New York and Eastern District of New York, where the same expert’s opinion has been offered and ruled upon by those judges. Their rulings are hearsay, but hearsay is acceptable. So I may use their rulings as a basis for my decision on whether to allow it or not.” Id. at 4. Even after Judge Jack Weinstein excluded plaintiffs’ expert witnesses’ causal opinions in the silicone litigation, however, Judge Pointer avoided having to make an MDL-wide decision with the scope of one of the leading judges from the Southern and Eastern Districts of New York. See In re Breast Implant Cases, 942 F. Supp. 958 (E. & S.D.N.Y. 1996). Judge Pointer repeated his anti-Daubert views three years later at a symposium on expert witness opinion testimony. See Sam C. Pointer, Jr., “Response to Edward J. Imwinkelried, the Taxonomy of Testimony Post-Kumho: Refocusing on the Bottom Lines of Reliability and Necessity,” 30 Cumberland L. Rev. 235 (2000).

[3]  In re Silica Products Liab. Litig., MDL No. 1553, 398 F. Supp. 2d 563 (S.D. Tex. 2005).

[4]  In re Bextra & Celebrex Marketing Sales Practices & Prod. Liab. Litig., 524 F. Supp. 2d 1166 (N.D. Calif. 2007) (excluding virtually all relevant expert witness testimony proffered to support claims that ordinary dosages of these COX-2 inhibitors caused cardiovascular events).

[5]  In re Viagra Products Liab. Litig., 572 F. Supp. 2d 1071 (D. Minn. 2008) (addressing claims that sildenafil causes vision loss from non-arteritic anterior ischemic optic neuropathy (NAION)).

[6]  Rheingold (“Examining these five mass terminations, at least in retrospect[,] it is apparent that they were very weak on causation.”)

[7] See Elizabeth Chamblee Burch & Margaret S. Williams, “Repeat Players in Multidistrict Litigation: The Social Network,” 102 Cornell L. Rev. 1445 (2017); Margaret S. Williams, Emery G. Lee III & Catherine R. Borden, “Repeat Players in Federal Multidistrict Litigation,” 5 J. Tort L. 141, 149–60 (2014).

Posted in Causation, Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on Specious Claiming in Multi-District Litigation

Good Night Styrene

April 18th, 2019

Perri Klass is a pediatrician who writes fiction and non-fiction. Her editorial article on “disruptive chemicals,” in this week’s Science Section of the New York Times contained large segments of fiction.[1]  The Times gives Dr. Klass, along with Nicholas Kristof and others, a generous platform to advance their chemophobic propaganda, on pesticides, phthalates, bisphenols, and flame retardants, without the bother of having to cite evidence. It has been just two weeks since the Times published another Klass fear piece on hormone disrupters.[2]

In her Science Times piece, Klass plugged Leonardo Trasande’s book, Sicker, Fatter, Poorer: The Urgent Threat of Hormone-Disrupting Chemicals to Our Health and Future . . . and What We Can Do About It (2019), to help wind up parents about chemical threats everywhere. Trasande, is “an internationally renowned leader in environmental health” expert; his website tells us so. Klass relies so extensively upon Trasande that it is difficult to discern whether she is presenting anything other than his opinions, which in some places she notes he has qualified as disputed and dependent upon correlational associations that have not established causal associations.

When it comes to recyclable plastic, number 6, Klass throws all journalistic caution and scientific scruple aside and tells us that “[a] number 6 denotes styrene, which is a known carcinogen.”[3] Known to whom? To Trasande? To Klass? To eco-zealots?

The first gaffe is that number 6 plastic, of course, is not styrene; rather it is polystyrene. Leaching of monomer certainly can occur,[4] and is worth noting, but equating polystyrene with styrene is simply wrong. The second gaffe, more serious yet, is that styrene is not a “known” carcinogen.

The International Agency for Research on Cancer, which has been known to engage in epistemic inflation about carcinogenicity, addressed styrene in its monograph 82.[5] Styrene was labeled a “2B” carcinogen, that is possible, not probable, and certainly not “known.” Last year, an IARC working group revisited the assessment of styrene, and in keeping with its current practice of grade inflation bumped styrene up to Group 2A, “probably carcinogenic to humans” based upon limited evidence in human being and sufficient evidence in rats and close relatives.[6] In any event, the IARC Monograph number 121, which will address styrene, is under preparation.

A responsible journalist, or scientist, regulator, or lawyer, is obligated however to note tha “probably” does not mean “more likely than not” in IARC-jargon.[7] Given that all empirical propositions have a probability of being true, somewhere between 0 and 100%, but never actually equal to 0 or 100%, the IARC classifications of “probably” causing cancer are probably not particularly meaningful.  Everything “probably” causes cancer, in this mathematical sense.[8]

In the meanwhile, what does the scientific community have to say about the carcinogenicity of styrene?

Recent reviews and systematic reviews of the styrene carcinogenicity issue have mostly concluded that there is no causal relationship between styrene exposure and any form of cancer in humans.[9] Of course, the “Lobby,” scientists in service to the litigation industry, disagree.[10]

[1]  Perri Klass, “Beware of Disruptive Chemicals,” N.Y. Times (April 16, 2019).

[2] Perri Klass, “How to Minimize Exposures to Hormone Disrupters,” N.Y. Times (April 1, 2019).

[3]  Klass (April 16, 2019), at D6, col. 3.

[4]  See, e.g., Despoina Paraskevopoulou, Dimitris Achiliasa, and Adamantini Paraskevopoulou, “Migration of styrene from plastic packaging based on polystyrene into food simulants,” 61 Polymers Internatl’l 141 (2012); J. R. Withey, “Quantitative Analysis of Styrene Monomerin Polystyrene and Foods Including Some Preliminary Studies of the Uptake and Pharmacodynamics of the Monomer in Rats,” 17 Envt’l Health Persp. 125 (1976).

[5]  IARC Monograph No. 82, at 437-78 (2002).

[6]  IARC Working Group, “Carcinogenicity of quinoline, styrene, and styrene-7,8-oxide,” 19 Lancet Oncology 728 (2018).

[7]  The IARC Preamble definition of probable reveals that “probable” does not mean greater than 50%. See also “The IARC Process is Broken” (May 4, 2016).

[8] See Ed Yong, “Beefing With the World Health Organization’s Cancer Warnings,” The Atlantic (Oct 26, 2015).

[9]  Boffetta, P., Adami, H. O., Cole, P., Trichopoulos, D. and Mandel, J. S., “Epidemiologic studies of styrene and cancer: a review of the literature,” 51 J. Occup. & Envt’l Med. 1275 (2009) (“The available epidemiologic evidence does not support a causal relationship between styrene exposure and any type of human cancer.”); James J. Collins & Elizabeth Delzell, “A systematic review of epidemiologic studies of styrene and cancer,” 48 Critical Revs. Toxicol. 443 (2018)  (“Consideration of all pertinent data, including substantial recent research, indicates that the epidemiologic evidence on the potential carcinogenicity of styrene is inconclusive and does not establish that styrene causes any form of cancer in humans.”).

[10] James Huff & Peter F. Infante, “Styrene exposure and risk of cancer,” 26 Mutagenesis 583 (2011).

Posted in Causation, Scientific Evidence, Scientific Publishing | Comments Off on Good Night Styrene

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

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The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.