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People Get Ready – There’s a Reference Manual a Comin’

July 16th, 2021

Science is the key …

Back in February, I wrote about a National Academies’ workshop that featured some outstanding members of the scientific and statistical world, and which gave participants to identify new potential subjects for inclusion in a proposed fourth edition of the Reference Manual on Scientific Evidence.[1] Funding for that new edition is now secured, and the National Academies has published a précis of the February workshop. National Academies of Sciences, Engineering, and Medicine, Emerging Areas of Science, Engineering, and Medicine for the Courts: Proceedings of a Workshop – in Brief (Washington, DC 2021). The Rapporteurs for these proceedings provide a helpful overview for this meeting, which was not generally covered in the legal media.[2]

The goal of the workshop, which was supported by a planning committee, the Committee on Science, Technology, and Law, the National Academies, the Federal Judicial Center, and the National Science Foundation, was, of course, to identify chapters for a new, fourth edition, of Reference Manual on Scientific Evidence. The workshop was co-chaired by Dr. Thomas D. Albright, of the Salk Institute for Biological Studies, and the Hon. Kathleen McDonald O’Malley, Judge on the U.S. Court of Appeals for the Federal Circuit.

The Rapporteurs duly noted Judge O’Malley’s Workshop comments that she hoped that the reconsideration of the Reference Manual can help close the gap between science and the law. It is thus encouraging that the Rapporteurs focused a large part of their summary on the presentation of Professor Xiao-Li Meng[3] on selection bias, which “can come from cherry picking data, which alters the strength of the evidence.” Meng identified the

“7 S’(ins)” of selection bias:

(1) selection of target/hypothesis (e.g., subgroup analysis);

(2) selection of data (e.g., deleting ‘outliers’ or using only ‘complete cases’);

(3) selection of methodologies (e.g., choosing tests to pass the goodness-of-fit); (4) selective due diligence and debugging (e.g., triple checking only when the outcome seems undesirable);

(5) selection of publications (e.g., only when p-value <0.05);

(6) selections in reporting/summary (e.g., suppressing caveats); and

(7) selections in understanding and interpretation (e.g., our preference for deterministic, ‘common sense’ interpretation).”

Meng also addressed the problem of analyzing subgroup findings after not finding an association in the full sample, dubious algorithms, selection bias in publishing “splashy” and nominally “statistically significant” results, and media bias and incompetence in disseminating study results. Meng discussed how these biases could affect the accuracy of research findings, and how these biases obviously affect the accuracy, validity, and reliability of research findings that are relied upon by expert witnesses in court cases.

The Rapporteurs’ emphasis on Professor Meng’s presentation was noteworthy because the current edition of the Reference Manual is generally lacking in a serious exploration of systematic bias and confounding. To be sure, the concepts are superficially addressed in the Manual’s chapter on epidemiology, but in a way that has allowed many district judges to shrug off serious questions of invalidity with the shibboleth that such questions “to to the weight, not the admissibility,” of challenged expert witness opinion testimony. Perhaps the pending revision to Rule 702 will help improve fidelity to the spirit and text of Rule 702.

Questions of bias and noise have come to receive more attention in the professional statistical and epidemiologic literature. In 2009, Professor Timothy Lash published an important book-length treatment of quantitative bias analysis.[4] Last year, statistician David Hand published a comprehensive, but readily understandable, book on “Dark Data,” and the ways statistical and scientific interference are derailed.[5] One of the presenters at the February workshop, nobel laureate, Daniel Kahneman, published a book on “noise,” just a few weeks ago.[6]

David Hand’s book, Dark Data, (Chapter 10) sets out a useful taxonomy of the ways that data can be subverted by what the consumers of data do not know. The taxonomy would provide a useful organizational map for a new chapter of the Reference Manual:

A Taxonomy of Dark Data

Type 1: Data We Know Are Missing

Type 2: Data We Don’t Know Are Missing

Type 3: Choosing Just Some Cases

Type 4: Self- Selection

Type 5: Missing What Matters

Type 7: Changes with Time

Type 8: Definitions of Data

Type 9: Summaries of Data

Type 11: Feedback and Gaming

Type 12: Information Asymmetry

Type 13: Intentionally Darkened Data

Type 14: Fabricated and Synthetic Data

Type 15: Extrapolating beyond Your Data

Providing guidance not only on “how we know,” but also on how we go astray, patho-epistemology, would be helpful for judges and lawyers. Hand’s book really just a beginning to helping gatekeepers appreciate how superficially plausible health-effects claims are invalidated by the data relied upon by proffered expert witnesses.

* * * * * * * * * * * *

“There ain’t no room for the hopeless sinner
Who would hurt all mankind, just to save his own, believe me now
Have pity on those whose chances grow thinner”

[1] “Reference Manual on Scientific Evidence v4.0” (Feb. 28, 2021).

[2] Steven Kendall, Joe S. Cecil, Jason A. Cantone, Meghan Dunn, and Aaron Wolf.

[3] Prof. Meng is the Whipple V. N. Jones Professor of Statistics, in Harvard University. (“Seeking simplicity in statistics, complexity in wine, and everything else in fortune cookies.”)

[4] Timothy L. Lash, Matthew P. Fox, and Aliza K. Fink, Applying Quantitative Bias Analysis to Epidemiologic Data (2009).

[5] David J. Hand, Dark data : why what you don’t know matters (2020).

[6] Daniel Kahneman, Olivier Sibony, and Cass R. Sunstein, Noise: A Flaw in Human Judgment (2021).

Posted in Evidence, Expert Witnesses, Reference Manual on Scientific Evidence, Rule 702, Rule 703, Scientific Evidence, Systemic Bias | No Comments »

Slide Rule 702

June 26th, 2021

Note: A “fatal error,” caused by an old theme has disrupted the layout of my website. I am working on it

The opposition to Daubert’s regime of gatekeeping by the lawsuit industry has been fierce. From the beginning, the resistance has found allies on the bench, who have made the application of Rule 702 to expert witnesses, in both civil and criminal, uneven at best. Back in 2015, Professor David Bernstein and Eric Lasker wrote an exposé, about the unlawful disregard of the statutory language of Rule 702, and they called for and proposed an amendment to the rule.[1] At the time, I was skeptical of unleashing a change through the rules committee, given the uncertainty of where any amendment might ultimately look like.[2]

In the last several years, there have been some notable applications of Rule 702 in litigation involving sertraline, atorvastatin, sildenafil, and other medications, but aberrant decisions have continued to upend the rule of law in the area of expert witness gatekeeping. Last year, I noted that I had come to see the wisdom of Professor Bernstein’s proposal,[3] in the light of continued judicial dodging of Rule 702.[4] Numerous lawyers and legal organizations have chimed in to urge a revision to Rule 702.[5]

Earlier this week, the Committee on Rules of Practice & Procedure rolled out a proposed draft of an amended Rule 702.[6] The proposed new rule looks very much like the current rule:[7]

  1. Rule Testimony by Expert Witnesses
  2. A witness   who   is   qualified   as   an   expert   by
  3. knowledge, skill,  experience,  training,  or  education may
  4. testify in the form of an opinion or otherwise if the proponent
  5. has demonstrated by a preponderance of the evidence that:
  6. (a) the  expert’s  scientific,  technical,  or  other
  7. specialized knowledge will help the trier of
  8. fact  to   understand   the   evidence   or   to
  9. determine a fact in issue;
  10. (b) the testimony is based on sufficient facts or
  11. data;
  12. (c) the  testimony  is  the  product  of  reliable
  13. principles and methods; and
  14. (d) the  expert  has  reliably  applied  expert’s
  15. opinion reflects a reliable application of the
  16. principles and methods to the facts of the
  17. case

Despite what looks like minor linguistic changes, the Rules Committee’s note suggests otherwise. First, the amendment is intended to emphasize that the burden of showing the admissibility requirements rests on the proponent of the challenged expert witness testimony. Of course, the burden of course has always been with the proponent, but some courts have deployed various strategems to shift the burden with conclusory assessments that the challenge “goes to the weight not the admissibility,” thereby dodging the judicial responsibility for gatekeeping. The Committee now would make clear that many courts have erred by having treated the “critical questions of the sufficiency of an expert’s basis, and the application of the expert’s methodology” as going to weight and not admissibility.[8]

The Committee appears, however, to be struggling to provide guidance on when challenges do raise “matters of weight rather than admissibility.” For instance, the Committee Note suggests that:

“nothing in the amendment requires the court to nitpick an expert’s opinion in order to reach a perfect expression of what the basis and methodology can support. The Rule 104(a) standard does not require perfection. On the other hand, it does not permit the expert to make extravagant claims that are unsupported by the expert’s basis and methodology.”[9]

Somehow, I fear that the mantra of “weight not admissibility” has been or will be replaced by refusals to nitpick an expert’s opinion. How many nits does it take to make a causal claim “extravant”?

Perhaps I am the one nitpicking now. The Committee has recognized the essential weakness of gatekeeping as frequently practiced in federal courts by emphasizing that judicial gatekeeping is “essential” and required by the institutional incompetence of jurors to determine whether expert witnesses have reliably applied sound methodology to the facts of the case:

“a trial judge must exercise gatekeeping authority with respect to the opinion ultimately expressed by a testifying expert. A testifying expert’s opinion must stay within the bounds of what can be concluded by a reliable application of the expert’s basis and methodology. Judicial gatekeeping is essential because just as jurors may be unable to evaluate meaningfully the reliability of scientific and other methods underlying expert opinion, jurors may also be unable to assess the conclusions of an expert that go beyond what the expert’s basis and methodology may reliably support.”[10]

If the sentiment of the Rule Committee’s draft note carries through to the Committee Note that accompanies the amended rule, then perhaps some good will come of this effort.

[1] David E. Bernstein & Eric G. Lasker,“Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 William & Mary L. Rev. 1 (2015).

[2] “On Amending Rule 702 of the Federal Rules of Evidence” (Oct. 17, 2015).

[3] “Should Federal Rule of Evidence 702 Be Amended?” (May 8, 2020).

[4] “Dodgy Data Duck Daubert Decisions” (April 2, 2020); “Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions” (May 11, 2020); “Judicial Dodgers – Reassigning the Burden of Proof on Rule 702” (May 13, 2020); “Judicial Dodgers – Weight not Admissibility” (May 28, 2020); “Judicial Dodgers – Rule 702 Tie Does Not Go to Proponent” (June 2, 2020).

[5] See, e.g., Daniel Higginbotham, “The Proposed Amendment to Federal Rule of

Evidence 702 – Will it Work?” IADC Products Liability Newsletter (March 2021); Cary Silverman, “Fact or Fiction: Ensuring the Integrity of Expert Testimony,” U.S. Chamber Instit. Leg. Reform (Feb. 2021); Thomas D. Schroeder, “Federal Courts, Practice & Procedure: Toward a More Apparent Approach to Considering the Admission of Expert Testimony,” 95 Notre Dame L. Rev. 2039, 2043 (2020); Lee Mickus, “Gatekeeping Reorientation: Amend Rule 702 To Correct Judicial Misunderstanding about Expert Evidence,” Wash. Leg. Foundation (May 2020)

13-18 (noting numerous cases that fail to honor the spirit and language of Rule 702); Lawyers for Civil Justice, “Comment to the Advisory Comm. on Evidence Rules and its Rule 702 Subcommittee; A Note about the Note: Specific Rejection of Errant Case Law is Necessary for the Success of an Amendment Clarifying Rule 702’s Admissibility Requirements 1 (Feb. 8, 2021) (arguing that “[t]he only unambiguous way for the Note to convey the intent of the amendment is to reject the specific offending caselaw by name.”).

[6] Committee on Rules of Practice & Procedure Agenda Book (June 22, 2021). See Email Cara Salvatore, “Court Rules Committee Moves to Stiffen Expert Standard,” Law360 (June 23, 2021).

[7] Id. at 836. The proposal has been the subject of submissions and debate for a while. See Jim Beck, “Civil Rules Committee Proposes to Toughen Rule 702,” Drug & Device Law (May 4, 2021).

[8] Committee on Rules of Practice & Procedure Agenda Book at 839 (June 22, 2021).

[9] Id.

[10] Id. at 838-39.

Posted in Evidence, Expert Witnesses, Rule 702 | No Comments »

A Proclamation from the Task Force on Statistical Significance

June 21st, 2021

The American Statistical Association (ASA) has finally spoken up about statistical significance testing.[1] Sort of.

Back in February of this year, I wrote about the simmering controversy over statistical significance at the ASA.[2] Back in 2016, the ASA issued its guidance paper on p-values and statistical significance, which sought to correct misinterpretations and misrepresentations of “statistical significance.”[3] Lawsuit industry lawyers seized upon the ASA statement to proclaim a new freedom from having to exclude random error.[4] To obtain their ends, however, the plaintiffs’ bar had to distort the ASA guidance in statistically significant ways.

To add to the confusion, in 2019, the ASA Executive Director published an editorial that called for an end to statistical significance testing.[5] Because the editorial lacked disclaimers about whether or not it represented official ASA positions, scientists, statisticians, and lawyers on all sides were fooled into thinking the ASA had gone whole hog.[6] Then ASA President Karen Kafadar stepped into the breach to explain that the Executive Director was not speaking for the ASA.[7]

In November 2019, members of the ASA board of directors (BOD) approved a motion to create a “Task Force on Statistical Significance and Replicability.”[8] Its charge was

“to develop thoughtful principles and practices that the ASA can endorse and share with scientists and journal editors. The task force will be appointed by the ASA President with advice and participation from the ASA BOD. The task force will report to the ASA BOD by November 2020.

The members of the Task Force identified in the motion were:

Linda Young (Nat’l Agricultural Statistics Service & Univ. of Florida; Co-Chair)

Xuming He (Univ. Michigan; Co-Chair)

Yoav Benjamini (Tel Aviv Univ.)

Dick De Veaux (Williams College; ASA Vice President)

Bradley Efron (Stanford Univ.)

Scott Evans (George Washington Univ.; ASA Publications Representative)

Mark Glickman (Harvard Univ.; ASA Section Representative)

Barry Graubard (Nat’l Cancer Instit.)

Xiao-Li Meng (Harvard Univ.)

Vijay Nair (Wells Fargo & Univ. Michigan)

Nancy Reid (Univ. Toronto)

Stephen Stigler (Univ. Chicago)

Stephen Vardeman (Iowa State Univ.)

Chris Wikle (Univ. Missouri)

Tommy Wright (U.S. Census Bureau)

Despite the inclusion of highly accomplished and distinguished statisticians on the Task Force, there were isolated demurrers. Geoff Cumming, for one, clucked:

“Why won’t statistical significance simply whither and die, taking p <. 05 and maybe even p-values with it? The ASA needs a Task Force on Statistical Inference and Open Science, not one that has its eye firmly in the rear view mirror, gazing back at .05 and significance and other such relics.”[9]

Despite the clucking, the Taskforce arrived at its recommendations, but curiously, its report did not find a home in an ASA publication. Instead, the “The ASA President’s Task Force Statement on Statistical Significance and Replicability” has now appeared as an “in press” publication at The Annals of Applied Statistics, where Karen Kafadar is the editor in chief.[10] The report is accompanied by an editorial by Kafadar.[11]

The Taskforce advanced five basic propositions, which may have been obscured by some of the recent glosses on the ASA 2016 p-value statement:

  1. “Capturing the uncertainty associated with statistical summaries is critical.”
  2. “Dealing with replicability and uncertainty lies at the heart of statistical science. Study results are replicable if they can be verified in further studies with new data.”
  3. “The theoretical basis of statistical science offers several general strategies for dealing with uncertainty.”
  4. “Thresholds are helpful when actions are required.”
  5. “P-values and significance tests, when properly applied and interpreted, increase the rigor of the conclusions drawn from data.”

All of this seems obvious and anodyne, but I suspect it will not silence the clucking.

[1] Deborah Mayo, “Alas! The ASA President’s Task Force Statement on Statistical Significance and Replicability,” Error Statistics (June 20, 2021).

[2] “Falsehood Flies – The ASA 2016 Statement on Statistical Significance” (Feb. 26, 2021).

[3] Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” 70 The Am. Statistician 129 (2016); see “The American Statistical Association’s Statement on and of Significance” (March 17, 2016).

[4] “The American Statistical Association Statement on Significance Testing Goes to Court – Part I” (Nov. 13, 2018); “The American Statistical Association Statement on Significance Testing Goes to Court – Part 2” (Mar. 7, 2019).

[5] “Has the American Statistical Association Gone Post-Modern?” (Mar. 24, 2019); “American Statistical Association – Consensus versus Personal Opinion” (Dec. 13, 2019). See also Deborah G. Mayo, “The 2019 ASA Guide to P-values and Statistical Significance: Don’t Say What You Don’t Mean,” Error Statistics Philosophy (June 17, 2019); B. Haig, “The ASA’s 2019 update on P-values and significance,” Error Statistics Philosophy  (July 12, 2019); Brian Tarran, “THE S WORD … and what to do about it,” Significance (Aug. 2019); Donald Macnaughton, “Who Said What,” Significance 47 (Oct. 2019).

[6] Ronald L. Wasserstein, Allen L. Schirm, and Nicole A. Lazar, “Editorial: Moving to a World Beyond ‘p < 0.05’,” 73 Am. Statistician S1, S2 (2019).

[7] Karen Kafadar, “The Year in Review … And More to Come,” AmStat News 3 (Dec. 2019) (emphasis added); see Kafadar, “Statistics & Unintended Consequences,” AmStat News 3,4 (June 2019).

[8] Karen Kafadar, “Task Force on Statistical Significance and Replicability,” ASA Amstat Blog (Feb. 1, 2020).

[9] See, e.g., Geoff Cumming, “The ASA and p Values: Here We Go Again,” The New Statistics (Mar. 13, 2020).

[10] Yoav Benjamini, Richard D. DeVeaux, Bradly Efron, Scott Evans, Mark Glickman, Barry Braubard, Xuming He, Xiao Li Meng, Nancy Reid, Stephen M. Stigler, Stephen B. Vardeman, Christopher K. Wikle, Tommy Wright, Linda J. Young, and Karen Kafadar, “The ASA President’s Task Force Statement on Statistical Significance and Replicability,” 15 Annals of Applied Statistics 2021, available at https://www.e-publications.org/ims/submission/AOAS/user/submissionFile/51526?confirm=79a17040.

[11] Karen Kafadar, “Editorial: Statistical Significance, P-Values, and Replicability,” 15 Annals of Applied Statistics 2021, available at https://www.e-publications.org/ims/submission/AOAS/user/submissionFile/51525?confirm=3079934e.

Posted in Scientific Evidence, statistical evidence | No Comments »

Judge Jack B. Weinstein – A Remembrance

June 17th, 2021

There is one less force of nature in the universe. Judge Jack Bertrand Weinstein died earlier this week, about two months shy of a century.[1] His passing has been noticed by the media, lawyers, and legal scholars[2]. In its obituary, the New York Times noted that Weinstein was known for his “bold jurisprudence and his outsize personality,” and that he was “revered, feared, and disparaged.” The obituary quoted Professor Peter H. Schuck, who observed that Weinstein was “something of a benevolent despot.”

As an advocate, I found Judge Weinstein to be anything but fearsome. His jurisprudence was often driven by intellectual humility rather than boldness or despotism. One area in which Judge Weinstein was diffident and restrained was in his exercise of gatekeeping of expert witness opinion. He, and his friend, the late Professor Margaret Berger, were opponents of giving trial judges discretion to exclude expert witness opinions on ground of validity and reliability. Their antagonism to gatekeeping was, no doubt, partly due to their sympathies for injured plaintiffs and their realization that plaintiffs’ expert witnesses often come up with dodgy scientific opinions to advance plaintiffs’ claims. In part, however, Judge Weinstein’s antagonism was due to his skepticism about judicial competence and his own intellectual humility.

Although epistemically humble, Judge Weinstein was not incurious. His interest in scientific issues occasionally got him into trouble, as when he was beguiled by Dr. Irving Selikoff and colleagues, who misled him on aspects of the occupational medicine of asbestos exposure. In 1990, Judge Weinstein issued a curious mea culpa. Because of a trial in progress, Judge Weinstein, along with state judge (Justice Helen Freedman), attended an ex parte private luncheon meeting with Dr. Selikoff. Here is how Judge Weinstein described the event:

“But what I did may have been even worse [than Judge Kelly’s conduct that led to his disqualification]. A state judge and I were attempting to settle large numbers of asbestos cases. We had a private meeting with Dr. Irwin [sic] J. Selikoff at his hospital office to discuss the nature of his research. He had never testified and would never testify. Nevertheless, I now think that it was a mistake not to have informed all counsel in advance and, perhaps, to have had a court reporter present and to have put that meeting on the record.”[3]

Judge Weinstein’s point about Selikoff’s having never testified was demonstrably false, but I impute no scienter for false statements to the judge. The misrepresentation almost certainly originated with Selikoff. Dr. Selikoff had testified frequently up to the point at which he and plaintiffs’ counsel realized that his shaky credentials and his pronouncements on “state of the art,” were hurtful to the plaintiffs’ cause. Even if Selikoff had not been an accomplished testifier, any disinterested observer should, by 1990, have known that Selikoff was himself not a disinterested actor in medical asbestos controversies.[4] The meeting with Selikoff apparently weighed on Judge Weinstein’s conscience. He repeated his mea culpa almost verbatim, along with the false statement about Selikoff’s never having testified, in a law review article in 1994, and then incorporated the misrepresentation into a full-length book.[5]

In his famous handling of the Agent Orange class action, Judge Weinstein manipulated the defendants into settling, and only then applied his considerable analytical ability in dissecting the inadequacies of the plaintiffs’ causation case. Rather than place the weight of his decision on Rule 702, Judge Weinstein dismembered the causation claim by finding that the bulk of what the plaintiffs’ expert witnesses relied upon under Rule 703 was unreasonable. He then found that what remained, if anything, could not reasonably support a verdict for plaintiffs, and he entered summary judgment for the defense in the opt-out cases.[6]

In 1993, the U.S. Supreme Court breathed fresh life into the trial court’s power and obligation to review expert witness opinions and to exclude unsound opinions.[7] Several months before the Supreme Court charted this new direction on expert witness testimony, the silicone breast implant litigation, fueled by iffy science and iffier scientists, erupted.[8] In October 1994, the Judicial Panel on Multi-District Litigation created MDL 926, which consolidated the federal breast implant cases before Judge Sam Pointer, in the Northern District of Alabama. Unlike most contemporary MDL judges, however, Judge Pointer did not believe that Rule 702 and 703 objections should be addressed by the MDL judge. Pointer believed strongly that the trial judges, in the individual, remanded cases, should rule on objections to the validity of proffered expert witness opinion testimony. As a result, so-called Daubert hearings began taking place in district courts around the country, in parallel with other centralized proceedings in MDL 926.

By the summer of 1996, Judge Robert E. Jones had a full-blown Rule 702 attack on the plaintiffs’ expert witnesses before him, in a case remanded from MDL 926. In the face of the plaintiffs’ MDL leadership committee’s determined opposition, Judge Jones appointed four independent scientists to serve as scientific advisors. With their help, in December 1996, Judge Jones issued one of the seminal rulings in the breast implant litigation, and excluded the plaintiffs’ expert witnesses.[9]

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

I had one of the first witnesses, Dr. Donnard Dwyer, before Judge Weinstein during that chilly autumn of 1996. Dwyer was a very earnest immunologist, who appeared on direct examination to endorse the methodological findings of the plaintiffs’ expert witnesses, including a very dodgy study by Dr. Douglas Shanklin. On cross-examination, I elicited Dwyer’s view that the Shanklin study involved fraudulent methodology and that he, Dwyer, would never use such a method or allow a graduate student to use it. This examination, of course, was great fun, and as I dug deeper with relish, Judge Weinstein stopped me, and asked rhetorically to the plaintiffs’ counsel, whether any of them intended to rely upon the discredited Shanklin study. My main adversary Mike Williams did not miss a beat; he jumped to his feet to say no, and that he did not know why I was belaboring this study. But then Denise Dunleavy, of Weitz & Luxenberg, knowing that Shanklin was her listed expert witness in many cases, rose to say that her expert witnesses would rely upon the Shanklin study. Incredulous, Weinstein looked at me, rolled his eyes, paused dramatically, and then waved his hand at me to continue.

Later in my cross-examination, I was inquiring about another study that reported a statistic from a small sample. The authors reported a confidence interval that included negative values for a test that could not have had any result less than zero. The sample was obviously skewed, and the authors had probably used an inappropriate parametric test, but Dwyer was about to commit to the invalidity of the study when Judge Weinstein stopped me. He was well aware that the normal approximation had created the aberrant result, and that perhaps the authors only sin was in failing to use a non-parametric test. I have not had many trial judges interfere so knowledgably.

In short order, on October 23, 1996, Judge Weinstein issued a short, published opinion, in which he ducked the pending Rule 702 motions, and he granted partial summary judgment on the claims of systemic disease.[10] Only the lawyers involved in the matters would have known that there was no pending motion for summary judgment!

Following up with grant of summary judgment, Judge Weinstein appointed a group of scientists and a legal scholar, to help him assemble a panel of Rule 706 expert witnesses for future remanded case. Law Professor Margaret Berger, along with Drs. Joel Cohen and Alan Wolff, began meeting with the lawyers to identify areas of expertise needed by the court, and what the process of court-appointment of neutral expert witnesses would look like.

The plaintiffs’ counsel were apoplectic. They argued to Judge Weinstein that Judge Pointer, in the MDL, should be supervising the process of assembling court-appointed experts. Of course, the plaintiffs’ lawyers knew that Judge Pointer, unlike Judges Jones and Weinstein, believed that both sides’ expert witnesses were extreme, and mistakenly believed that the truth lay between. Judge Pointer was an even bigger foe of gatekeeping, and he was generally blind to the invalid evidence put forward by plaintiffs. In response to the plaintiffs’ counsel’s, Judge Weinstein sardonically observed that if there were a real MDL judge, he should take it over.

Within a month or so, Judge Pointer did, in fact, take over the court-appointed expert witness process, and incorporated Judge Weinstein’s selection panel. The process did not going very smoothly in front of the MDL judge, who allowed the plaintiffs lawyers to slow down the process by throwing in irrelevant documents and deploying rhetorical tricks. The court-appointed expert witnesses did not take kindly to the shenanigans, or to the bogus evidence. The expert panel’s unanimous rejection of the plaintiffs’ claims of connective tissue disease causation was an expensive, but long overdue judgment from which there was no appeal. Not many commentators, however, know that the panel would never have happened but for Judge Weinstein’s clever judicial politics.

In April 1997, while Judge Pointer was getting started with the neutral expert selection panel,[11] the parties met with Judge Weinstein one last time to argue the defense motions to exclude the plaintiffs’ expert witnesses. Invoking the pendency of the Rule 706 court-appointed expert witness processs in the MDL, Judge Weinstein quickly made his view clear that he would not rule on the motions. His Honor also made clear that if we pressed for a ruling, he would deny our motions, even though he had also ruled that plaintiffs’ could not make out a submissible case on causation.

I recall still the frustration that we, the defense counsel, felt that April day, when Judge Weinstein tried to explain why he would grant partial summary judgment but not rule on our motions contra plaintiffs’ expert witnesses. It would be many years later, before he let his judicial assessment see the light of day. Two decades and then some later, in a law review article, Judge Weinstein made clear that “[t]he breast implant litigation was largely based on a litigation fraud. …  Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”[12] Indeed.

Judge Weinstein was incredibly smart and diligent, but he was human with human biases and human fallibilities. If he was a despot, he was at least kind and benevolent. In my experience, he was always polite to counsel and accommodating. Appearing before Judge Weinstein was a pleasure and an education.

[1] Laura Mansnerus, “Jack B. Weinstein, U.S. Judge With an Activist Streak, Is Dead at 99,” N.Y. Times (June 15, 2021).

[2] Christopher J. Robinette, “Judge Jack Weinstein 1921-2021,” TortsProf Blog (June 15, 2021).

[3] Jack B. Weinstein, “Learning, Speaking, and Acting: What Are the Limits for Judges?” 77 Judicature 322, 326 (May-June 1994).

[4] “Selikoff Timeline & Asbestos Litigation History” (Dec. 20, 2018).

[5] See Jack B. Weinstein, “Limits on Judges’ Learning, Speaking and Acting – Part I- Tentative First Thoughts: How May Judges Learn?” 36 Ariz. L. Rev. 539, 560 (1994) (“He [Selikoff] had never testified and would never testify.”); Jack B. Weinstein, Individual Justice in Mass Tort Litigation: The Effect of Class Actions, Consolidations, and other Multi-Party Devices 117 (1995) (“A court should not coerce independent eminent scientists, such as the late Dr. Irving Selikoff, to testify if, like he, they prefer to publish their results only in scientific journals.”)

[6] In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 785 (E.D.N.Y. 1984), aff’d 818 F.2d 145, 150-51 (2d Cir. 1987)(approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988);  In re “Agent Orange” Prod. Liab. Litig., 611 F. Supp. 1223 (E.D.N.Y. 1985), aff’d, 818 F.2d 187 (2d Cir. 1987), cert. denied, 487 U.S. 1234 (1988).

[7] Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

[8] Reuters, “Record $25 Million Awarded In Silicone-Gel Implants Case,” N.Y. Times (Dec. 24, 1992).

[9] See Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Ore. 1996).

[10] In re Breast Implant Cases, 942 F. Supp. 958 (E.& S.D.N.Y. 1996).

[11] MDL 926 Order 31 (May 31, 1996) (order to show cause why a national Science Panel should not be appointed under Federal Rule of Evidence 706); MDL 926 Order No. 31C (Aug. 23, 1996) (appointing Drs. Barbara S. Hulka, Peter Tugwell, and Betty A. Diamond); Order No. 31D (Sept. 17, 1996) (appointing Dr. Nancy I. Kerkvliet).

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

Posted in Asbestos, Causation, Expert Witnesses, Rule 702, Rule 703, Scientific Evidence, Scientific Misconduct | No Comments »

Scientists Suing Scientists, and Behaving Badly

June 2nd, 2021

In his 1994 Nobel Prize acceptance speech, the Hungarian born chemist George Andrew Olah acknowledged an aspect of science that rarely is noted in popular discussions:

“[One] way of dealing with errors is to have friends who are willing to spend the time necessary to carry out a critical examination of the experimental design beforehand and the results after the experiments have been completed. An even better way is to have an enemy. An enemy is willing to devote a vast amount of time and brain power to ferreting out errors both large and small, and this without any compensation. The trouble is that really capable enemies are scarce; most of them are only ordinary. Another trouble with enemies is that they sometimes develop into friends and lose a good deal of their zeal. It was in this way the writer lost his three best enemies. Everyone, not just scientists, need a few good enemies!”[1]

If you take science seriously, you must take error as something for which we should always be vigilant, and something we are committed to eliminate. As Olah and Von Békésy have acknowledged, sometimes an enemy is required. It would thus seem to be quite unscientific to complain that an enemy was harassing you, when she was criticizing your data, study design, methods, or motives.

Elisabeth Margaretha Harbers-Bik would be a good enemy to have. Trained in the Netherlands in microbiology, Dr. Bik came to the United States, where for some years she conducted research at Stanford University. In 2018, Bik began in earnest a new career in analyzing published scientific studies for image duplication and manipulation, and other dubious practices.[2]

Her blog, Scientific Integrity Digest, should be on the reading list of every lawyer who labors in the muck of science repurposed for litigation. You never know when your adversary’s expert witness will be featured in the pages of the Digest!

Dr. Bik is not a lone ranger; there are other scientists who have committed to cleaning up the scientific literature. After an illustrious career as an editor of prestigious journals, and a director of the Rockefeller University Press, Dr. Mike Rossner founded Image Data Integrity, Inc., to stamp out image fraud and error in scientific publications.

On March 16, 2020, a gaggle of French authors, including Dr. Didier Raoult, uploaded a pre-print of a paper to medRxiv, reporting on hydroxychloroquine (HCQ) and azithromycin in Covid-19 patients. The authors submitted their manuscript that same day to the International Journal of Antimicrobial Agents, which accepted it in 24 hours or less, on March 17, 2020. The journal published the paper online, three days after acceptance, on March 20th. Peer-review, to the extent it took place, was abridged.[3]

The misleading title of the paper, “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial,” may have led some untutored observers into thinking the paper reported a study high in the hierachy of evidence. Instead the paper was a rather flawed observational study, or perhaps just a concatenation of anecdotes. In any event, the authors reported that patients who had received both medications cleared the SARS-CoV2 the fastest.

Four days after publication online at a supposedly peer-reviewed journal, Elisabeth Bik posted an insightful analysis of the Raoult paper.[4] If peer review it were, her blog post pointed out the review’s failure by identifying an apparent conflict of interest and various methodological flaws, including missing data on six (out of 26) patients, including one patient who died, and three whose conditions worsened on therapy.

Raoult’s paper, and his overly zealous advocacy for HCQ did not go unnoticed in the world of kooks, speculators, and fraudfeasors. Elon Musk tweeted about Raoult’s paper; and Fox News amplified Musk’s tweet, which made it into the swamp of misinformation, Trump’s mind and his twitterverse.[5]

In the wake of the hoopla over Raoult’s paper, the journal owner admitted that the paper did not live up to the society’s standards. The publisher, Elsevier, called for an independent investigation. The French Infectious Diseases Society accused Raoult of spreading false information about hydroxychloroquine’s efficacy in Covid-19 patients. To date, there has been no further official discussions of disciplinary actions or proceedings at the Society.

Raoult apparently stewed over Bik’s criticisms and debunking of his over-interpretation of his flawed HCQ study.  Last month, Raoult filed a complaint with a French prosecutor, which marked the commencement of legal proceedings against Bik for harassment and “extortion.” The extortion charge is based upon nothing more than Bik’s having a Patreon account to support her search for fraud and error in the published medical literature.[6]

The initial expression of outrage over Marseille Raoult’s bad behavior came from Citizen4Science, a French not-for-profit organization that works to promote scientific integrity. According to Dr. Fabienne Blum, president of Citizen4Science, the organization issued its press release on May 5, 2021, to call on authorities to investigate and to intervene in Raoult’s harassment of scientists. Their press release about “the French scandal” was signed by scientists and non-scientists from around the world; it currently remains open for signatures, which number well over 4,000. “Harassment of scientific spokespersons and defenders of scientific integrity: Citizen4Science calls on the authorities to intervene urgently” (May 5, 2021). Dr. Blum and Citizen4Science are now harassed on Twitter, where they have been labeled “Bik’s gang.” Inevitably, they will be sued as well.

On June 1st, Dr. Raoult posted his self-serving take on the controversy on that scholarly forum known as YouTube. An English translation of Raoult’s diatribe can be found at Citizen4Science’s website. Perhaps others have noted that Raoult refers to Bik as “Madame” (or Mrs.) Bik, rather than as Dr. Bik, which leads to some speculation that Raoult has trouble taking criticism from intelligent women.

Having projected his worst characteristics onto adversaries, Raoult lodged accusations against Bik, which actually reflected his own behaviors closely. Haven’t we seen someone in public life who operates just like this? Raoult has criticized Bik in the lay media, and he released personal information about her, including her residential address. Raoult’s intemperate and inappropriate personal attacks on Bik have led several hundred scientists to sign an open letter in support of Bik.[7]

This scientist doth protest too much, methinks.

[1] George Andrew Olah Nobel Prize Speech (1994) (quoting from George Von Békésy, Experiments in Hearing 8 (1960).

[2] Elisabeth M. Bik, Arturo Casadevall, and Ferric C. Fang, “The Prevalence of Inappropriate Image Duplication in Biomedical Research Publications,” 7 mBio e00809 (2016); Daniele Fanelli, Rodrigo Costas, Ferric C. Fang, Arturo Casadevall, Elisabeth M. Bik, “Testing Hypotheses on Risk Factors for Scientific Misconduct via Matched-Control Analysis of Papers Containing Problematic Image Duplications,” 25 Science & Engineering Ethics 771 (2019); see also Jayashree Rajagopalan, “I have found about 2,000 problematic papers, says Dr. Elisabeth Bik,” Editage Insights (Aug 08, 2019).

[3] Philippe Gautret, Jean-Christophe Lagier, Philippe Parola, Van Thuan Hoang, Line Meddeb, Morgane Mailhe, Barbara Doudier, Johan Courjon, Valérie Giordanengo, Vera Esteves Vieira, Hervé Tissot Dupont, Stéphane Honoré, Philippe Colson, Eric Chabrière, Bernard La Scola, Jean-Marc Rolain, Philippe Brouqui, and Didier Raoult, “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial,” 56 Clinical Trial Internat’l J. Antimicrob. Agents e105949 (2020).

[4] Bik, “Thoughts on the Gautret et al. paper about Hydroxychloroquine and Azithromycin treatment of COVID-19 infections,” Scientific Integrity Digest (March 24, 2020).

[5] Charles Piller, “‘This is insane!’ Many scientists lament Trump’s embrace of risky malaria drugs for coronavirus,” Science Mag. (Mar. 26, 2020).

[6] Melissa Davey, “World expert in scientific misconduct faces legal action for challenging integrity of hydroxychloroquine study,” The Guardian (May 22, 2021); Kristina Fiore, “HCQ Doc Sues Critic,” MedPage Today (May 26, 2021).

[7] Lonni Besançon, Alexander Samuel, Thibault Sana, Mathieu Rebeaud, Anthony Guihur, Marc Robinson-Rechavi, Nicolas Le Berre, Matthieu Mulot, Gideon Meyerowitz-Katz, Maisonneuve, Brian A. Nosek, “Open Letter: Scientists stand up to protect academic whistleblowers and post-publication peer review,” (May 18, 2021).

Posted in Cognitive Biases, Conflicts of Interest, Peer Review, Scientific Evidence, Scientific Misconduct | No Comments »

The Practicing Law Institute’s Second Edition of Products Liability Litigation

May 30th, 2021

In late March, the Practicing Law Institute released the second edition of its treatise on products liability. George D. Sax, Stephanie A. Scharf, Sarah R. Marmor, eds., Product Liability Litigation: Current Law, Strategies and Best Practices, (2nd ed. 2021).

The new edition is now in two volumes, which cover substantive products liability law, as well as legal theory, policy, and strategy considerations important to products liability law, both pursuers and defenders. The work of the editors, Stephanie A. Scharf and her colleagues, George D. Sax and Sarah R. Marmor, in managing this process is nothing short of Homeric.  The authors are mostly practitioners, with a wealth of practical experience. There are a good number of friends, colleagues, and adversaries, among the chapters’ authors, so any recommendation I make should be tempered by my disclosure.

Unlike the first edition, the PLI has doubled down on control of the copyright license, and so I am no longer able to upload my chapter on statistical evidence to ResearchGate, Academia.com, or my own website.  But here is the outline index to my contribution, Chapter 28, “Statistical Evidence in Products Liability Litigation”:

  • 28:1 History and Overview
  • 28:2 Litigation Context of Statistical Issues
  • 28:3 Qualifications of Expert Witnesses Who Give Testimony on Statistical Issues
  • 28:4 Admissibility of Statistical Evidence – Rules 702 and 703
  • 28:5 Significance Probability
  • 28:5.1 Definition of Significance Probability (The “p-value”)
  • 28:5.2 Misstatements about Statistical Significance
  • 28:5.3 Transposition Fallacy
  • 28:5.4 Confusion Between Significance Probability and Burden of Proof
  • 28:5.5 Hypothesis Testing
  • 28:5.6 Confidence Intervals
  • 28:5.7 Inappropriate Use of Statistics – Matrixx  Initiatives
    • [A]     Sequelae of Matrixx Initiatives
    • [B]     Is Statistical Significance Necessary?
  • 28: 5.8 American Statistical Association’s Statemen on P-Values
  • 28:6 Statistical Power
  • 28:6.1 Definition of Statistical Power
  • 28:6.2 Cases Involving Statistical Power
  • 28:7 Evidentiary Rule of Completeness
  • 28:8 Meta-Analysis
  • 28:8.1 Definition and History of Meta-Analysis
  • 28:8.2 Consensus  Statements
  • 28:8.3 Use of Meta-Analysis in Litigation
  • 28:8.4 Competing Models for Meta-Analysis
  • 28:8.5 Recent Cases Involving Meta-Analyses
  • 28:9 Statistical Inference in Securities Fraud Cases Against Pharmaceutical Manufacturers
  • 28:10 Multiple Testing
  • 28:11 Ethical Considerations Raised by Statistical Expert Witness Testimony
  • 28:12 Conclusion

A detailed table of contents for the entire treatise is available at the PLI’s website The authors and their chapters are set out below.

Chapter 1. What Product Liability Might Look Like in the Twenty-First Century (James M. Beck)

Chapter 2. Recent Trends in Product Claims and Product Defenses (Lori B. Leskin & Angela R. Vicari)

Chapter 3. Game-Changers: Defending Products Cases with Child Plaintiffs (Sandra Giannone Ezell & Diana M. Miller)

Chapter 4. Preemption Defenses (Joseph G. Petrosinelli, Ana C. Reyes & Amy Mason Saharia)

Chapter 5. Defending Class Action Lawsuits (Mark Herrmann, Pearson N. Bownas & Katherine Garceau Sobiech)

Chapter 6. Litigation in Foreign Countries Against U.S. Companies (Joseph G. Petrosinelli & Ana C. Reyes)

Chapter 7. Emerging Issues in Pharmaceutical Litigation (Allen P. Waxman, Loren H. Brown & Brooke Kim)

Chapter 8. Recent Developments in Asbestos, Talc, Silica, Tobacco, and E-Cigarette/Vaping Litigation in the U.S. and Canada (George Gigounas, Arthur Hoffmann, David Jaroslaw, Amy Pressman, Nancy Shane Rappaport, Wendy Michael, Christopher Gismondi, Stephen H. Barrett, Micah Chavin, Adam A. DeSipio, Ryan McNamara, Sean Newland, Becky Rock, Greg Sperla & Michael Lisanti)

Chapter 9. Emerging Issues in Medical Device Litigation (David R. Geiger, Richard G. Baldwin, Stephen G.W. Stich & E. Jacqueline Chávez)

Chapter 10. Emerging Issues in Automotive Product Liability Litigation (Eric P. Conn, Howard A. Fried, Thomas N. Lurie & Nina A. Rosenbach)

Chapter 11. Emerging Issues in Food Law and Litigation (Sarah L. Brew & Joelle Groshek)

Chapter 12. Regulating Cannabis Products (James H. Rotondo, Steven A. Cash & Kaitlin A. Canty)

Chapter 13. Blockchain Technology and Its Impact on Product Litigation (Justin Wales & Matt Kohen)

Chapter 14. Emerging Trends: Smart Technology and the Internet of Things (Christopher C. Hossellman & Damion M. Young)

Chapter 15. The Law of Damages in Product Liability Litigation (Evan D. Buxner & Dionne L. Koller)

Chapter 16. Using Early Case Assessments to Develop Strategy (Mark E. (Rick) Richardson)

Chapter 17. Impact of Insurance Policies (Kamil Ismail, Linda S. Woolf & Richard M. Barnes)

Chapter 18. Advantages and Disadvantages of Multidistrict Litigation (Wendy R. Fleishman)

Chapter 19. Strategies for Co-Defending Product Actions (Lem E. Montgomery III & Anna Little Morris)

Chapter 20. Crisis Management and Media Strategy (Joanne M. Gray & Nilda M. Isidro)

Chapter 21. Class Action Settlements (Richard B. Goetz, Carlos M. Lazatin & Esteban Rodriguez)

Chapter 22. Mass Tort Settlement Strategies (Richard B. Goetz & Carlos M. Lazatin)

Chapter 23. Arbitration (Beth L. Kaufman & Charles B. Updike)

Chapter 24. Privilege in a Global Product Economy (Marina G. McGuire)

Chapter 25. E-Discovery—Practical Considerations (Denise J. Talbert, John C. Vaglio, Jeremiah S. Wikler & Christy A. Pulis)

Chapter 26. Expert Evidence—Law, Strategies and Best Practices (Stephanie A. Scharf, George D. Sax, Sarah R. Marmor & Morgan G. Churma)

Chapter 27. Court-Appointed and Unconventional Expert Issues (Jonathan M. Hoffman)

Chapter 28. Statistical Evidence in Products Liability Litigation (Nathan A. Schachtman)

Chapter 29. Post-Sale Responsibilities in the United States and Foreign Countries (Kenneth Ross & George W. Soule)

Chapter 30. Role of Corporate Executives (Samuel Goldblatt & Benjamin R. Dwyer)

Chapter 31. Contacting Corporate Employees (Sharon L. Caffrey, Kenneth M. Argentieri & Rachel M. Good)

Chapter 32. Spoliation of Product Evidence (Paul E. Benson & Adam E. Witkov)

Chapter 33. Presenting Complex Scientific Evidence (Morton D. Dubin II & Nina Trovato)

Chapter 34. How to Win a Dismissal When the Plaintiff Declares Bankruptcy (Anita Hotchkiss & Earyn Edwards)

Chapter 35. Juries (Christopher C. Spencer)

Chapter 36. Preparing for the Appeal (Wendy F. Lumish & Alina Alonso Rodriguez)

Chapter 37. Global Reach: Foreign Defendants in the United States (Lisa J. Savitt)

Posted in Rule 702, Scientific Evidence, Silica, statistical evidence | 65 Comments »

NJ Appellate Division Calls for Do Over in Baby Powder Dust Up

May 22nd, 2021

There was quite a bit of popular media reporting of the $117 million (compensatory and punitive damages) awarded by a Middlesex County, New Jersey, jury to a man who claimed his mesothelioma had been caused by his use of baby powder. There was much less media coverage last month of the New Jersey Appellate Division’s reversal of the underlying verdicts, on grounds that the trial Judge Ana C. Viscomi had abused her discretion on several key issues.[1] The New Jersey appellate court reversed the trial court’s judgment, and remanded the Lanzo case for a new trial, in a carefully reasoned decision.[2]

Johnson & Johnson Consumer Inc. (JJCI) and Imerys Talc America, Inc. (Imerys) appealed from the judgment entered by Judge Viscomi, on April 23, 2018. The appellants lodged several points of error, but the most erroneous of the erroneous trial court decisions seemed to involve a laissez-faire attitude to weak and unreliable proffered expert witness opinions.

Judge Viscomi conducted a Rule 104 hearing on the admissibility of testing of plaintiffs’ expert witness, William Longo, on crowd-sourced samples of baby powder, without chain of custody or provenance evidence. Judge Viscomi denied the challenge to Longo’s test results.

The defense had also filed Rule 702 challenges to plaintiffs’ expert witnesses, James S. Webber, Ph.D., and Jacqueline Moline, M.D., and their opinion that non-asbestiform amphibole cleavage fragments can cause mesothelioma. Judge Viscomi refused these pre-trial motions, and refused to conduct a pre-trial Rule 104 hearing on the proffered opinions. Her Honor’s denial of the Rule 702 was accompanied with little to no reasoning, which proved to be the determinant of her abuse of discretion, and deviation from the standard of judicial care.

At trial, the defense re-asserted its objections to Moline’s opinion on cleavage fragments, but Judge Viscomi permitted Moline to testify about “non-asbestiform cleavage fragments from a medical point of view.” In other words, the trial judge gave Dr. Moline carte blanche to address causation.

Understandably, on appeal, JJCI and Imerys assigned various errors. With respect to the scientific evidence, the defendants alleged that plaintiffs’ expert witnesses (Webber and Moline) failed to:

“(1) explain what causes the human body to respond in the same way to the different mineral forms;

(2) acknowledge the contrary opinions of scientists and government agencies;

(3) provide evidentiary support for their opinion that non-asbestiform minerals can cause mesothelioma; and

(4) produce evidence that their theory that non-asbestiform minerals are harmful had been subject to peer-review and publication or was generally accepted in the scientific community.”

The Federal Fiber

The genesis of the scientific dispute lay in the evolution of the definition of asbestos itself. Historically, asbestos was an industrial term for one of six different minerals, the serpentine mineral chrysotile, and the amphibole minerals, amosite, crocidolite, tremolite, anthophyllite, and actinolite. Chrysotile is, by mineralogical definition, a serpentine mineral in fibrous form.  If not fibrous, the mineral is typically called antigorite.

For the five amphiboles, the definitional morass deepens. Amosite is, again, an industrial term, an acronym for “asbestos mines of South Africa,” although South Africa once mined chrysotile and crocidolite as well.  Amosite is an iron-rich amphibole in the cummingtonite-grunerite family, with a fibrous habit.  Cummingtonite-grunerite can be either fibrous or non-fibrous in mineral habit.

Crocidolite is an amphibole that by definition is fibrous. The same mineral, if not fibrous, is known as riebeckite. Crocidolite is, by far, the most potent cause of mesothelioma.

The remaining amphiboles, tremolite, anthophyllite, and actinolite, have the same mineralogical designation, regardless whether they occur as fibers or in non-fibrous forms.

The designation of a mineral as “asbestiform” is also rather vague, apparently conveying an industrial functionality from its fibrosity. Medically, the term asbestiform became associated with minerals that have sufficiently high aspect ratio, and small cross-sectional diameter, to be considered potentially capable of inducing pulmonary fibrosis or mesothelioma.

In 1992, the federal OSHA regulations removed non-asbestiform actinolite, tremolite, and anthophyllite from the safety standard, based upon substantial evidence that the non-asbestiform occurrences of these minerals did not present the health risks associated with asbestiform amphiboles. Because nothing is ever simple, the National Institute for Occupational Safety and Health (NIOSH) persisted in its recommendation that OSHA continue to regulate non-asbestiform amphiboles under asbestos regulatory standards. This NIOSH pronouncement, however, was extremely controversial among the ranks of NIOSH scientists. In any event, NIOSH recommendations are just that, suggestions and not binding regulations.

The mineralogical, medical, and regulatory definitions of asbestos and asbestiform minerals vary greatly, and require a great deal of discipline and precision in discussing what causes mesothelioma. The health effects of non-asbestiform minerals have been studied, however, and generally shown not to cause mesothelioma.[3]

Judge Viscomi Abused Her Discretion

The Appellate Division panel applied Accutane’s abuse of discretion standard, which permits judges to screw up to some extent, but requires reversal for their mistakes when “so wide off the mark that a manifest denial of justice resulted.” The appellate court had little difficulty in saying that the trial court was “so wide off the mark” in addressing expert witness opinion admissibility.

James Webber

In the Lanzo case, plaintiffs’ expert witnesses, James Webber and Jacqueline Moline, both opined that non-asbestiform minerals can cause mesothelioma. The gravamen of the defense’s appeal was that these expert witnesses had failed to support their opinions and that the trial judge had misapplied the established judicial gatekeeping procedures required by the New Jersey Supreme Court, in In re Accutane Litigation, 234 N.J. 340 (2018).

The Appellate Division then set out to do what Judge Viscomi had failed to do – look at the proffered opinions and assess whether they followed reasonably and reliably from the expert witnesses’ stated grounds. Although Webber opined that cleavage fragments could cause mesothelioma, he had never studied the issue himself; nor was he aware of any studies showing that showed that non-asbestiform cleavage fragments can cause mesothelioma. Webber had never expressed his opinion in scientific publications, and he failed to cite any support for his opinion in his report.

At trial, Judge Viscomi permitted Webber to go beyond his anemic report and to cite reliance upon four sources for his opinion. The Appellate Division carefully reviewed each of the four sources, and found that they either did not support Webber’s opinions or they were as equally without evidentiary support. “Webber did not identify any data underlying his opinion. Further, he did not demonstrate that any of the authorities he relied on would be reasonably relied on by other experts in his field to reach an opinion regarding causation.”

Webber cited an article by Victor Roggli, who opined that he had found asbestiform and non-asbestiform fibers in the lungs of mesothelioma patients, but who went on to conclude that fibers were the likely cause. Webber also cited an article by NIOSH scientist Martin Harper, who stated the opinion, without evidentiary support that NIOSH did not believe, in 2008, that there was “sufficient evidence for a different toxicity for non-asbestiform amphibole particles that meet the morphological criteria for a fiber.”[4]

Although Harper and company appeared to be speaking on behalf of NIOSH, in 2011, the agency clarified its position to state that its previous inclusion of non-asbestiform minerals in the definition of respirable asbestos fibers had been based upon “inclusive science”:

“Epidemiological evidence clearly indicates a causal relationship between exposure to fibers from the asbestos minerals and various adverse health outcomes, including asbestosis, lung cancer, and mesothelioma. However, NIOSH has viewed as inconclusive the results from epidemiological studies of workers exposed to EMPs[9] [elongate mineral particles] from the non[-]asbestiform analogs of the asbestos minerals.”[5]

The Appellate Division was equally unimpressed with Webber’s citation of a geologist who stated an opinion in 2009, that “using the term ‘asbestiform’ to differentiate a hazardous from a non-hazardous substance has no foundational basis in the medical sciences.” Not only was the geologist, Gregory P. Meeker, lacking in medical expertise, but his article was non-peer-reviewed (for what little good that would have done) and his opinion did not cite any foundational evidence or data in an appropriate scientific study.

Webber cited to an Environmental Protection Agency (EPA) document,[6] which stated that

“[f]or the purposes of public health assessment and protection, [the] EPA makes no distinction between fibers and cleavage fragments of comparable chemical composition, size, and shape.”

The Appellate Division observed that the EPA not provide any scientific support for its assessment. Furthermore, the language cited by Webber clearly suggests that the EPA was issuing a precautionary view, not a scientific one.

Considering the Daubert factors, and New Jersey precedent, the Appellate Division readily found that Webber’s opinion was inadmissible. His opinion about non-asbestiform minerals was unsupported by data and analysis in published, peer-reviewed studies; the opinion was clearly not generally accepted; and the opinion had never been published by Webber himself. Plaintiffs had failed to show that Webber’s “methodology involv[ed] data and information of the type reasonably relied on by experts in the scientific field.”[7] The trial court’s observation that the issue of cleavage fragments was “contested” could not substitute for the required assessment of methodology and of the underlying data relied upon by Webber. Judge Viscomi abused her discretion in admitting Webber’s testimony.

Jacqueline Moline

Moline’s expert testimony that non-asbestiform minerals can cause mesothelioma suffered from many of the same defects as Webber’s opinion on this topic. The trial court once again did not conduct a pre-trial or in-trial hearing to assess Moline’s opinion, and it did not perform the rigorous assessment required by Rule 702 and the Accutane case to determine whether Moline’s opinions met the applicable (so-called Daubert) standards. The Appellate Division emphatically held that the trial court erred in permitting Moline to testify, over objection.

Moline vacuously opined that non-asbestiform amphiboles cause mesothelioma, but failed to identify any specific studies that actually supported this proposition. Like Webber, she pointed to an EPA document, from 2006, which also failed to support her asseverations. Moline also claimed support from the CDC, the American Thoracic Society, and other EPA pronouncements, but never cited anything specifically. In her pre-trial report, Moline claimed that New York state talc minerals experienced mesotheliomas from exposure to the mining and milling of talc that contained about “50% non-asbestiform anthophyllite and tremolite.” Moline’s report, however, was devoid of any reference for this remarkable claim.

Moline’s trial testimony was embarrassed on cross-examination when the defense confronted her with prior testimony she gave in another case, in which she testified that she lacked “information … one way or the other” say whether non-asbestiform minerals were carcinogenic. Moline shrugged off the impeachment with a claim that she had since come to learn of mesothelioma occurrences among patients with non-asbestiform mineral exposures. Nonetheless, Moline still could not identify the studies she relied upon to answer the question whether “asbestos-related diseases can be caused by the non-asbestiform varieties of the six regulated forms of asbestos.”

Reversal and Remand

Having concluded that the trial court erred and abused its discretion in denying the defense motions contra Webber and Moline, and having found that the error was harmful to the defense’s right to a fair trial, the appellate court reversed and remanded for new (separate) trials against JJCI and Imerys. There will be, no doubt, attempts to persuade the New Jersey Supreme Court to consider the issues further. The state Supreme Court’s jurisdiction is discretionary, and assuming that the high Court rejects petitions for certification, the case will return to the Middlesex County trial court. The intended nature of further trial court proceedings is, at best, a muddle. The Appellate Division has already done what Judge Viscomi failed to do. The three-judge panel carefully reviewed the plaintiffs’ proffered opinion testimony on causation and found it inadmissible. It would thus seem that the order of business would be for the defense to file motions for summary judgment for lack of admissible causation opinions, and for the trial court to enter judgment for the defense.

————————————————————————————————————

[1] To be fair, there was some coverage in local, and in financial and legal media. See, e.g., Jef Feeley, “J&J Gets Banker’s $117 Million Talc Verdict Tossed on Appeal,” (April 28, 2021); Mike Deak, “Appeals court overturns $117 million Johnson & Johnson baby powder verdict,” My Central Jersey (April 28, 2021); “J&J, Imerys Beat $117M Talc Verdicts Over Flawed Testimony,” Law360 (April 28, 2021); Irvin Jackson, “$117M J&J Talc Cancer Verdict Overturned By New Jersey Appeals Court,” About Lawsuits (April 30, 2021).

[2] See Lanzo v. Cyprus Amax Minerals Co., Docket Nos. A-5711-17, A-5717-17, New Jersey Superior Court, App. Div. (April 28, 2021).

[3] See “Ingham v. Johnson & Johnson – A Case of Meretricious Mensuration?” (July 3, 2020); “ Tremolitic Tergiversation or Ex-PIRG-Gation?” (Aug. 11, 2018).

[4] “Differentiating Non-Asbestiform Amphibole and Amphibole Asbestos by Size Characteristics,” 5 J. Occup. & Envt’l Hygiene 761 (2008).

[5] NIOSH, “Asbestos Fibers and Other Elongate Mineral Particles: State of the Science and Roadmap for Research,” Current Intelligence Bulletin 62 (April 2011).

[6] The document in question was issued in 2006, by EPA Region 9, in response to a report prepared by R.J. Lee Group, Inc. The regional office of the EPA criticized the R.J. Lee report for applying “a [g]eologic [d]efinition rather than a [p]ublic [h]ealth [d]efinition to [c]haracterize [m]icroscopic [s]tructures,” noting that the EPA made “no distinction between fibers and cleavage fragments of comparable chemical composition, size, and shape.” This document thus did not address, with credible evidence, the key issue in the Lanzo case.

[7] Lanzo (quoting Rubanick, 125 N.J. at 449).

Posted in Asbestos, Causation, Expert Witnesses, Rule 702 | 1 Comment »

Disqualifying Expert Witnesses for Conflicts of Interest

March 30th, 2021

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

Side Switching

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

The Wang Test

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

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

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

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

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

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

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

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

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

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

Public Policy Limits on Wang

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

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

Procedural Issues

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

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

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

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

Mass Tort Cases

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

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

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

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

Practice Considerations

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

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

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

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

Role and Relationship Conflict

Managerial Employees

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

Treating Physicians

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

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

Treating Psychotherapists

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

——————————————————————————————–

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Posted in Conflicts of Interest, Expert Witness Discovery | 384 Comments »

The Misplaced Focus of Enterprise Liability on the Wrong Enterprise

March 27th, 2021

Well, soon the pandemic of Trump Flu will come to a close.  In the future, children too young or born after the pandemic will ask, “where were you during the pandemic, and what did you do?”

For lawyers, trials adjourned and courtrooms went dark, although discovery and motion practice continued. With some free time, I thought it a good time to write about the mess that American tort law has made of employer responsibility in product liability law. And the time seemed right because the Supreme Court had only recently provided a fascinating case study in how out of touch some courts can be with the realities of workplace injuries. The recent decision in DeVries v. Air & Liquid Systems Corp., 139 S.Ct. 986 (2019), was a perfect canvas on which to sketch out tort law’s failure to come to grips with the three-way relationship among industrial product seller, sophisticated industrial or military purchasers and employers, and injured plaintiffs.[1]

Many commentators might have viewed the justices who squared off in DeVries, Kavanaugh for the majority, Gorsuch for the dissent, as cut from the same judicial cloth, but their two opinions diverged in interesting ways. The entire court, however, shared a frail and faulty understanding of the role of third-party employers and product purchasers in providing a safe workplace. Not surprisingly, both the majority and dissenting opinions failed to do justice to the depth of Navy knowledge of the hazards of asbestos, Navy control over the workplace, and the futility of warning of asbestos exposure to the Navy, which had superior knowledge of both general asbestos hazards, the specific conditions it created, and the methods needed to protect its workers and sailors.

The failings of scholarship and analysis in DeVries have a bigger context.[2] The role of third parties – sophisticated intermediaries – received careful consideration in the First and Second Restatements of Torts, in Section 388 and its comments.[3] The Third Restatement continued to endorse this important defense, based upon the practical and sensible limits of liability, but placed the relevant discussion in a hard-to-find comment to a very broad, general section:

“5. The Restatement, Second, of Torts § 388, Comment n, utilizes the same factors set forth in Comment i in deciding whether a warning should be given directly to third persons. It has been relied on by numerous courts. 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) (applying Virginia law)… .”[4]

At least these celebrated sophisticated intermediary defense cases were cited by the Third Restatement, in a comment. Many current tort textbooks fail to mention the defense at all.[5] Tort theorists stress the importance of the boundaries between consumers and industrial enterprises, but ignore the frequent setting in which the purchaser is itself an industrial enterprise, and has independent legal and regulatory duties to provide safe workplaces with the products at issue.[6] Highly sensitive to the need to protect ordinary consumers from the predations of large manufacturing companies, many tort theorists are insensate to the need to protect manufacturers-sellers from the predations of large employing purchasing corporations upon the purchasers’ employees.[7]

Many scholars have written about the United States government’s historical knowledge of asbestos dangers,[8] but without any sense of outrage or concern, such as you might find in the purple prose of Paul Brodeur.[9] Although Brodeur did ever so slightly touch upon lawsuits against the United States government for conditions in Naval shipyards and elsewhere, he quoted with seeming approval the comments by Captain George M. Lawton, given in a 1979 interview. When asked whether the Navy was responsible for workplace conditions at the Navy’s Electric Boat shipyard, Lawton flippantly shrugged off the suggestion with the observation:

“If I order an automobile and the way they make automobiles is to throw people into a furnace, I am not responsible for that.”[10]

Brodeur, who was quick to judge the asbestos product manufacturers, fails to note that it was Captain Lawton’s Navy that was throwing people in furnace at its Navy yards around the country. Similarly, asbestos plaintiffs’ expert witness, Barry Castleman, who had written a trial manual for plaintiffs’ lawyers based upon distorted assessment of individual companies’ historical involvement with asbestos, spends no time investigating the huge record of United States governmental knowledge of asbestos use.[11] Castleman, schooled by the lawsuit industry lawyers, understood that documenting the knowledge of the intermediary, product purchaser, and workplace owner, detracts from the David-and-Goliath narrative his retaining counsel needed to prevail in litigation. Writers such as Brodeur and Castleman are fond of citing historical writings of governmental health agencies for claims of health hazards. Captain Lawton’s Navy was, of course, possessed and was bound by the knowledge of those very same public health agencies.[12]

In the mid-1970’s, amidst economic turmoil, and declining military budgets, the United States Navy found itself with a big problem. Payments to civilians under the FECA (Federal Employees’ Compensation Act), a statute that gives civilian employees of shipyards the equivalent of workers’ compensation benefits, came right out of the Navy’s budget for shipbuilding. The Navy had no insurance for FECA payments, and suddenly it found itself facing a large uptick in the number of claims made by civilians for asbestos-related injuries. About the same time, many states adopted some version of strict product liability, some stricter than others. None was likely stricter than Pennsylvania’s version, which made referring to employer responsibility virtually impossible. Ultimately, the plaintiffs’ bar found that strict liability recoveries and settlements were too certain to encumber themselves and their clients with government liens, and they stopped filing their FECA cases altogether.

When I first started practicing “asbestos law,” I routinely found copies of letters from JAG lawyers to shipyard workers, in their personnel files. The letters notified the workers that they had been diagnosed with asbestosis, usually by a local pulmonary physician who performed contract services for surveillance for the shipyard. (These diagnosing physicians went on to make fortunes by serving as expert witnesses in subsequent civil litigation.) The letters notified the workers that they might have rights under FECA, but emphasized that the workers had remedies against the Navy’s vendors of asbestos-containing products, and that if they sued in tort, the Navy would have a lien against any recovery. In practice, the lien was so unwieldy, that most of the Philadelphia plaintiffs’ firms would forego filing the FECA claim altogether. Thus the Navy effectively limited its liability, and kept its munitions budgets intact, while dozens of its vendors went bankrupt. The cruel irony of the FECA (or workers’ compensation) statutes is that the employer pays regardless of fault, that the employer can’t be sued in civil actions, and that the employer can recover ~80% of its payments from settlements or judgment proceeds from a civil defendant.

The government’s role in fueling the explosion of asbestos civil actions has not received very much, if any, real scrutiny. What a story is hidden away in those old files! Not only did the Navy know of the asbestos hazards, hide them from its civilian workers, but when those workers got sick, the Navy turned on its outside suppliers by encouraging its workers to sue the suppliers, while hiding behind the exclusive remedy provision of the FECA.

The story of the Navy’s misdeeds, misrepresentations, and misinformation has been told, in bits and pieces, here and there. What was needed back in the 1980s was someone who could write a thorough documentary history of the Navy’s predations upon its employees and its sailors. There is a trove of materials from before World War II, but increasing dramatically with the wartime efforts of Dr. Philip Drinker to obtain safe asbestos workplaces for both workers both at contract and naval shipyards.

In the postwar period, Navy culpability became even clearer. In 1957, for instance, more than a decade after Drinker’s investigations and reports of asbestos safety hazards, the Navy held a Conference of Pipe and Copper Shop Master Mechanics, at the Boston Naval Shipyard, on May 8 -10. Representatives from every naval shipyard, as well as the Bureau of Ships, and Commander Simpson, were present. A master pipefitter, O.W. Meeker, visiting from Shop 56, Long Beach Naval Shipyard, presented on “Pipe Insulation Processes and Procedures.” Notwithstanding confusion between asbestosis and silicosis, and between asbestos and silica, Mr. Meeker’s remarks speak volumes about the government’s role in the “asbestos mess”:

“The asbestos which we use is a mineral as much as is the rock in which it is found. Furthermore, its principal ingredient is silicon, which is responsible for the disease which we know as silicosis [sic].

Asbestos, silicosis, is caused by prolonged breathing of silica dust [sic]. Asbestos, when handled dry, produces vast amounts of silica dust. In new applications the material can be dampened to reduce the amount of dust liberated. However, the specified type of amosite for use on cold water piping is water repellent. Also material which must be removed from an existing installation is dry and powdery, being an excellent dustproducer.

The most apparent symptom of asbestosis is lethargy or a lack of vitality. What we suspect to be lead in the posterior might well be asbestos in the lungs. During 1956, 11 deaths from asbestosis were reported on the Pacific Coast alone. One insulator died of asbestosis at the age of 29.

Asbestosis is extremely difficult to detect – particularly at the early stages. I know that two of my insulators are afflicted with this condition. How many more will become afflicted is something which I hesitate to predict. Again, the solution is obvious. Remove the cause by substituting other products such as Armaflex or StaFoam for asbestos whenever possible. However, this will take some doing.

In the meantime, the answer is wearing of respirators by all who handle asbestos products. To many the very idea of wearing respirator is repugnant. However, a respirator on the face is preferable to asbestos in the lungs.

Therefore, gentlemen, ours definitely is the important and difficult task of providing and installing effective insulating materials aboard Naval Vessels. Moreover, this task must be accomplished without sacrificing our workmen in the process.”

Tort law and history itself have been distorted by the law’s focus on manufacturing defendants as deep pockets simply because the purchasing enterprises have had immunity from civil liability.

———————————————————————————-

[1]  Schachtman, “Products Liability Law – Lessons from the Military and Industrial Contexts,” 13 J. Tort Law 303 (2020).

[2]  “Asbestos and Asbestos Litigation Are Forever” (Sept. 16, 2014).

[3]  Restatement (First) of Torts § 388, comment 1 (1934); Restatement (Second) of Torts § 388, comment n (1965).

[4]  Restatement (Third) of Torts: Products Liability § 2 Categories of Product Defect (1998), Comment i. Inadequate instructions or warnings.

[5] See, e.g., John C. P. Goldberg & Benjamin C. Zipursky, The Oxford Introductions to U.S. Law: Torts (2010); Anita Bernstein, Questions & Answers: Torts (3d ed. 2014); Saul Levmore & Catherine M. Sharkey, Foundations of Tort Law (2d ed. 2011); Mark A. Geistfeld, Principles of Products Liability (2006). But see John L. Diamond, Lawrence C. Levine, and Anita Bernstein, Understanding Torts 392 (6th ed. 2018) (citing Taylor v. American Chem. Council, 576 F.3d 16, 25 (1st Cir. 2009) (applying Massachusetts law, and affirming summary judgment for defendant PVC trade association on failure-to-warn claim, on ground that the plaintiff’s employer was a sophisticated use and well aware of the danger).

[6]  See, e.g., Gregory C. Keating, “Products Liability As Enterprise Liability,” 10 J. Tort Law 41, 60 (2017).

[7] Thomas H. Koenig & Michael L. Rustad, In Defense of Tort Law 2 (2001); Stephen R. Perry, “The Moral Foundations of Tort Law,” 77 Iowa L. Rev. 449 (1992).

[8] George M. Lawton & Paul J. Snyder, “Occupational Health Programs in United States Naval Shipyards,” 11 Envt’l Res. 162 (1976); Peter A. Nowinski, “Chronology of Asbestos Regulation in United States Workplaces,” in Karen Antman & Joseph Aisner, eds., Asbestos-Related Malignancy 99 (1986) (Nowinski represented the government in direct lawsuits against the United States for its role in creating the asbestos hazards of federal and contract shipyards); Jacqueline Karnell Corn & Jennifer Stan, “Historical Perspective on Asbestos: Policies and Protective Measures in World War II Shipbuilding,” 11 Am. J. Indus. Med. 359 (1987); Statement of Linda G. Morra, Associate Director Human Resources Division, on behalf of the United States General Accounting Office, “The Status of Asbestos Claims Against The Federal Government”; before the House Committee on the Judiciary, Subcommittee on Administrative Law and Governmental Relations (June 30, 1988); Samuel A. Forman, “U.S. Navy Shipyard Occupational Medicine Through World War II,” 30 J. Occup. Med. 28 (1988); Susan L. Barna, “Abandoning Ship: Government Liability for Shipyard Asbestos Exposures,” 67 New York Univ. L. Rev. 1034 (1992);  Kenneth W. Fisher, “Asbestos: Examining the Shipyard’s Responsibility: An examination of relevant U.S. archives from the 1930s through the 1980s” (2001); Denis H. Rushworth, “The Navy and Asbestos Thermal Insulation,” Naval Engineers J. 35 (Spring 2005); Danielle M. Dell, Bruce K. Bohnker, John G. Muller, Alan F. Philippi, Francesca K. Litow, W. Garry Rudolph, Jose E. Hernandez, David A. Hiland, “Navy Asbestos Medical Surveillance Program 1990–1999: Demographic Features and Trends in Abnormal Radiographic Findings,” 8 Military Med. 717 (2006); John L. Henshaw, Shannon H. Gaffney, Amy K. Madl & Dennis J. Paustenbach, “The Employer’s Responsibility to Maintain a Safe and Healthful Work Environment: An Historical Review of Societal Expectations and Industrial Practices,” 19 Employee Responsibilities & Rights J. 173 (2007); Kara Franke & Dennis Paustenbach, “Government and Navy knowledge regarding health hazards of Asbestos: A state of the science evaluation (1900 to 1970),” 23(S3) Inhalation Toxicology 1 (2011).

[9]  Paul Brodeur, Outrageous Misconduct: The Asbestos Industry on Trial (1985).

[10]  Id. at 251 (quoting Lawton’s interview published in Connecticut Magazine, in 1979).

[11]  Barry I. Castleman, Asbestos: Medical and Legal Aspects (1984).

[12]  See Miller v. Diamond Shamrock Co., 275 F.3d 414, 422-23 (5th Cir. 2001) (“There can be no reasonable dispute that knowledge possessed by the United States Public Health Service, … [and] the Navy’s Bureau of Medicine and Surgery is the knowledge of the military.”).

Posted in Historian Testimony, Learned and sophisticated intermediary, Sophisticated User, State of the Art | No Comments »

Cancel Causation

March 9th, 2021

The Subversion of Causation into Normative Feelings

The late Professor Margaret Berger argued for the abandonment of general causation, or cause-in-fact, as an element of tort claims under the law.[1] Her antipathy to the requirement of showing causation ultimately involved her deprecating efforts to inject due scientific care in gatekeeping of causation opinions. After a long, distinguished career as a law professor, Berger died in November 2010.  Her animus against causation and Rule 702, however, was so strong that her chapter in the third edition of the Reference Manual on Scientific Evidence, which came out almost one year after her death, she embraced the First Circuit’s notorious anti-Daubert decision in Milward, which also post-dated her passing.[2]

Despite this posthumous writing and publication by Professor Berger, there have been no further instances of Zombie scholarship or ghost authorship.  Nonetheless, the assault on causation has been picked up by Professor Alexandra D. Lahav, of the University of Connecticut School of Law, in a recent essay posted online.[3] Lahav’s essay is an extension of her work, “The Knowledge Remedy,” published last year.[4]

This second essay, entitled “Chancy Causation in Tort Law,” is the plaintiffs’ brief against counterfactual causation, which Lahav acknowledges is the dominant test for factual causation.[5] Lahav begins with a reasonable, reasonably understandable distinction between deterministic (necessary and sufficient) and probabilistic (or chancy in her parlance) causation.

The putative victim of a toxic exposure (such as glyphosate and Non-Hodgkin’s lymphoma) cannot show that his exposure was a necessary and sufficient determinant of his developing NHL. Not everyone similarly exposed develops NHL; and not everyone with NHL has been exposed to glyphosate. In Lahav’s terminology, specific causation in such a case is “chancy.” Lahav asserts, but never proves, that the putative victim “could never prove that he would not have developed cancer if he had not been exposed to that herbicide.”[6]

Lahav’s example presents an example of a causal claim, which involves both general and specific causation, which is easily distinguishable from someone who claims his death was caused by being run over by a high-speed train. Despite this difference, Lahav never marshals any evidence to show why the putative glyphosate victim cannot show a probability that his case is causally related by adverting to the magnitude of the relative risk created by the prior exposure.

Repeatedly, Lahav asserts that when causation is chancy – probabilistic – it can never be shown by counterfactual causal reasoning, which she claims “assumes deterministic causation.” And she further asserts that because probabilistic causation cannot fit the counterfactual model, it can never “meet the law’s demand for a binary determination of cause.”[7]

Contrary to these ipse dixits, probabilistic causation can, at both the general and specific, or individual, levels be described in terms of counterfactuals. The modification requires us, of course, to address the baseline situation as a rate or frequency of events, and the post-exposure world as one with a modified rate or frequency. The exposure is the cause of the change in event rates. Modern physics addresses whether we must be content with probability statements, rather than precise deterministic “billiard ball” physics, which is so useful in a game of snooker, but less so in describing quarks. In the first half of the 20th century, the biological sciences learned with some difficulty that it must embrace probabilistic models, in genetic science, as well as in epidemiology. Many biological causation models are completely stated in terms of probabilities that are modified by specified conditions.

When Lahav gets to providing an example of where chancy causation fails in reasoning about individual causation, she gives a meaningless hypothetical of a woman, Mary, who is a smoker who develops lung cancer. To remove any semblance to real world cases, Lahav postulates that Mary had a 20% increased risk of lung cancer from smoking (a relative risk of 1.2). Thus, Lahav suggests that:

“[i]f Mary is a smoker and develops lung cancer, even after she has developed lung cancer it would still be the case that the cause of her cancer could only be described as a likelihood of 20 percent greater than what it would have been otherwise. Her doctor would not be able to say to her ‘Mary, if you had not smoked, you would not have developed this cancer’ because she might have developed it in any event.”

A more pertinent, less counterfactual hypothetical, is that Mary had a 2,000% increase in risk from her tobacco smoking. This corresponds to the relative risks in the range of 20, seen in many, if not most, epidemiologic studies of smoking and lung cancer. And there is an individual probability of causation that would be well over 0.9, for such a risk.

To be sure, there are critics of using the probability of causation because it assumes that the risk is distributed stochastically, which may not be correct. Of course, claimants are free to try to show that more of the risk fell on them for some reason, but of course, this requires evidence!

Lahav attempts to answer this point, but her argument runs off its rails.  She notes that:

“[i]f there is an 80% chance that a given smoker’s cancer is caused by smoking, and Mary smoked, some might like to say that she has met her burden of proof.

This approach confuses the strength of the evidence with its content. Assume that it is more likely than not, based on recognized scientific methodology, that for 80% of smokers who contract lung cancer their cancer is attributable to smoking. That fact does not answer the question of whether we ought to infer that Mary’s cancer was caused by smoking. I use the word ought advisedly here. Suppose Mary and the cigarette company stipulate that 80% of people like Mary will contract lung cancer, the burden of proof has been met. The strength of the evidence is established. The next question regards the legal permissibility of an inference that bridges the gap between the run of cases and Mary. The burden of proof cannot dictate the answer. It is a normative question of whether to impose liability on the cigarette company for Mary’s harm.”[8]

Lahav is correct that an 80% probability of causation might be based upon very flimsy evidence, and so that probability alone cannot establish that the plaintiff has a “submissible” case. If the 80% probability of causation is stipulated, and not subject to challenge, then Lahav’s claim is remarkable and contrary to most of the scholarship that has followed the infamous Blue Bus hypothetical. Indeed, she is making the very argument that tobacco companies made in opposition to the use of epidemiologic evidence in tobacco cases, in the 1950s and 1960s.

Lahav advances a perverse skepticism that any inferences about individuals can be drawn from information about rates or frequencies in groups of similar individuals.  Yes, there may always be some debate about what is “similar,” but successive studies may well draw the net tighter around what is the appropriate class. Lahav’s skepticism and her outright denialism, is common among some in the legal academy, but it ignores that group to individual inferences are drawn in epidemiology in multiple contexts. Regressions for disease prediction are based upon individual data within groups, and the regression equations are then applied to future individuals to help predict those individuals’ probability of future disease (such as heart attack or breast cancer), or their probability of cancer-free survival after a specific therapy. Group to individual inferences are, of course, also the basis for prescribing decisions in clinical medicine.  These are not normative inferences; they are based upon evidence-based causal thinking.

Lahav suggests that the metaphor of a “link” between exposure and outcome implies “something is determined and knowable, which is not possible in chancy causation cases.”[9] Not only is the link metaphor used all the time by sloppy journalists and some scientists, but when they use it, they mostly use it in the context of what Lahav would characterize as “chancy causation.” Even when speaking more carefully, and eschewing the link metaphor, scientists speak of probabilistic causation as something that is real, based upon evidence and valid inferences, not normative judgments or emotive reactions.

The probabilistic nature of the probability of causation does not affect its epistemic status.

The law does not assume that binary deterministic causality, as Lahav describes, is required to apply “but for” or counterfactual analysis. Juries are instructed to determine whether the party with the burden of proof has prevailed on each element of the claim, by a preponderance of the evidence. This civil jury instruction is almost always explained in terms of a posterior probability greater than 0.5, whether the claimed tort is a car crash or a case of Non-Hodgkin’s lymphoma.

Elsewhere, Lahav struggles with the concept of probability. Her essay suggests that

“[p]robability follows certain rules, or tendencies, but these regular laws do not abolish chance. There is a chance that the exposure caused his cancer, and a chance that it did not.”[10]

The use of chance here, in contradistinction to probability, is so idiosyncratic, and unexplained, that it is impossible to know what is meant.

Manufactured Doubt

Lahav’s essay twice touches upon a strawperson argument that stretches to claim that “manufacturing doubt” does not undermine her arguments about the nature of chancy causation. To Lahav, the likes of David Michaels have “demonstrated” that manufactured uncertainty is a genuine problem, but not one that affects her main claims. Nevertheless, Lahav remarkably sees no problem with manufactured certainty in the advocacy science of many authors.[11]

Lahav swallows the Michaels’ line, lure and all, and goes so far as to describe Rule 702 challenges to causal claims as having the “negative effect” of producing “incentives to sow doubt about epidemiologic studies using methodological battles, a strategy pioneered by the tobacco companies … .”[12] There is no corresponding concern about the negative effect of producing incentives to overstate the findings, or the validity of inferences, in order to get to a verdict for claimants.

Post-Modern Causation

What we have then is the ultimate post-modern program, which asserts that cause is “irreducibly chancy,” and thus indeterminate, and rightfully in the realm of “normative decisions.”[13] Lahav maintains there is an extreme plasticity to the very concept of causation:

“Causation in tort law can be whatever judges want it to be… .”[14]

I for one sincerely doubt it. And if judges make up some Lahav-inspired concept or normative causation, the scientific community would rightfully scoff.

Taking Lahav’s earlier paper, “The Knowledge Remedy,” along with this paper, the reader will see that Lahav is arguing for a rather extreme, radical precautionary principle approach to causation. There is a germ of truth that gatekeeping is affected by the moral quality of the defendant or its product. In the early days of the silicone gel breast implant litigation, some judges were influenced by suggestions that breast implants were frivolous products, made and sold to cater to male fantasies. Later, upon more mature reflection, judges recognized that roughly one third of breast implant surgeries were post-mastectomy, and that silicone was an essential biomaterial.  The recognition brought a sea change in critical thinking about the evidence proffered by claimants, and ultimately brought a recognition that the claimants were relying upon bogus and fraudulent evidence.[15]

—————————————————————————————–

[1]  Margaret A. Berger, “Eliminating General Causation: Notes towards a New Theory of Justice and Toxic Torts,” 97 Colum. L. Rev. 2117 (1997).

[2] Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir. 2011), cert. denied sub nom., U.S. Steel Corp. v. Milward, 132 S. Ct. 1002 (2012)

[3]  Alexandra D. Lahav, “Chancy Causation in Tort,” (May 15, 2020) [cited as Chancy], available at https://ssrn.com/abstract=3633923 or http://dx.doi.org/10.2139/ssrn.3633923.

[4]  Alexandra D. Lahav, “The Knowledge Remedy,” 98 Texas L. Rev. 1361 (2020). See “The Knowledge Remedy Proposal” (Nov. 14, 2020).

[5]  Chancy at 2 (citing American Law Institute, Restatement (Third) of Torts: Physical & Emotional Harm § 26 & com. a (2010) (describing legal history of causal tests)).

[6]  Id. at 2-3.

[7]  Id.

[8]  Id. at 10.

[9]  Id. at 12.

[10]  Id. at 2.

[11]  Id. at 8 (citing David Michaels, The Triumph of Doubt: Dark Money and the Science of Deception (2020), among others).

[12]  Id. at 18.

[13]  Id. at 6.

[14]  Id. at 3.

[15]  Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in silicone litigation as “charlatans” and the litigation as largely based upon fraud).

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