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WOE — Zoloft Escapes a MDL While Third Circuit Creates a Conceptual Muddle

July 31st, 2017

Multidistrict Litigations (MDLs) can be “muddles” that are easy to get in, but hard to get out of. Pfizer and subsidiary Greenstone fabulously escaped a muddle through persistent lawyering and the astute gatekeeping of a district judge, in the Eastern District of Pennsylvania. That judge, the Hon. Cynthia Rufe, sustained objections to the admissibility of plaintiffs’ epidemiologic expert witness Anick Bérard. When the MDL’s plaintiffs’ steering committee (PSC) demanded, requested, and begged for a do over, Judge Rufe granted them one more chance. The PSC put their litigation industry eggs in a single basket, carried by statistician Nicholas Jewell. Unfortunately for the PSC, Judge Rufe found Jewell’s basket to be as methodologically defective as Bérard’s, and Her Honor excluded Jewell’s proffered testimony. Motions, paper, and appeals followed, but on June 2, 2017, the Third Circuit declared that the PSC and its clients had had enough opportunities to get through the gate. Their baskets of methodological deplorables were not up to snuff. In re Zoloft Prod. Liab. Litig., No. 16-2247 , __ F.3d __, 2017 WL 2385279, 2017 U.S. App. LEXIS 9832 (3d Cir. June 2, 2017) (affirming exclusion of Jewell’s dodgy opinions, which involved multiple methodological flaws and failures to follow any methodology faithfully) [Slip op. cited below as Zoloft].

Plaintiffs Attempt to Substitute WOE for Depressingly Bad Expert Witness Opinion

The ruse of conflating “weight of the evidence,” as used to describe the appellate standard of review for sustaining or reversing a trial court’s factual finding with a purported scientific methodology for inferring causation, was on full display by the PSC in their attack on Judge Rufe’s gatekeeping. In their appellate brief in the Court of Appeals for the Third Circuit, the PSC asserted that Jewell had used a “weight of the evidence method,” even though that phrase, “weight of the evidence” (WOE) was never used in Jewell’s litigation reports. The full context of the PSC’s argument and citations to Milward make clear a deliberate attempt to conflate WOE as an appellate judicial standard for reviewing jury fact finding and a purported scientific methodology. See Appellants’ Opening Brief at 54 (Aug. 10, 2016) [cited as PSC] (asserting that “[a]t all times, the ultimate evaluation of the weight of the evidence is a jury question”; citing Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11, 20 (1st Cir. 2011), cert. denied, 133 S. Ct. 63 (2012).

Having staked the ground that WOE is akin to a jury’s factual finding, and thus immune to any but the most extraordinary trial court action or appellate intervention, the PSC then pivoted to claim that Jewell’s WOE-ful method was nothing much more than an assessment of “the totality of the available scientific evidence, guided by the well-accepted Bradford-Hill criteria.” PSC at 3, 4, 7. This maneuver allowed the PSC to argue, apparently with a straight face, that WOE methodology as used by Jewell, had been generally accepted in the scientific community, as well as by the Third Circuit, in previous cases in which the court accepted the use of Bradford Hill’s considerations as a reliable method for establishing general causation. See PSC at 4 (citing Gannon v. United States, 292 F. App’x 170, 173 n.1 (3d Cir. 2008)). Jewell then simply plugged in his expertise and “40 years of experience,” and the desired conclusion of causation popped out. Id. Quod erat demonstrandum.

In pressing its point, the PSC took full advantage of loose, inaccurate language from the American Law Institute’s Restatement’s notorious comment C:

“No algorithm exists for applying the Hill guidelines to determine whether an association truly reflects a causal relationship or is spurious.”

PSC at 33-34, citing Restatement (Third) of Torts: Physical and Emotional Harm § 28 cmt. c(3) (2010). Well true, but the absence of a mathematical algorithm hardly means that causal judgments are devoid of principles and standards. The PSC was undeterred, by text or by shame, from equating an unarticulated use of WOE methodology with some vague invocation of Bradford Hill’s considerations for evaluating associations for causality. See PSC at 43 (citing cases that never mentioned WOE but only Bradford Hill’s 50-plus year old heuristic as somehow supporting the claimed identity of the two approaches)¹.

Pfizer Rebuffs WOE

Pfizer filed a comprehensive brief that unraveled the PSC’s duplicity. For unknown reasons, tactical or otherwise, however, Pfizer did not challenge the specifics of PSC’s equation of WOE with an abridged, distorted application of Bradford Hill’s considerations. See generally Opposition Brief of Defendants-Appellees Pfizer Inc., Pfizer International LLC, and Greenstone LLC [cited as Pfizer]. Perhaps given page limits and limited judicial attention spans, and just how woefully bad Jewell’s opinions were, Pfizer may well have decided that a more directed approach of assuming arguendo WOE’s methodological appropriateness was a more economical, pragmatic approach. A close reading of Pfizer’s brief, however, makes clear that it never conceded the validity of WOE as a scientific methodology.

Pfizer did point to the recasting of Jewell’s aborted attempt to apply Bradford Hill considerations as an employment of WOE methodology. Pfizer at 46-47. The argument reminded me of Abraham Lincoln’s famous argument:

“How many legs does a dog have if you call his tail a leg?

Four.

Saying that a tail is a leg doesn’t make it a leg.”

Allen Thorndike Rice, Reminiscences of Abraham Lincoln by Distinguished Men of His Time at 242 (1909). Calling Jewell’s supposed method WOE or Bradford Hill or WOE/Bradford Hill did not cure the “fatal methodological flaws in his opinions.” Pfizer at 47.

Pfizer understandably and properly objected to the PSC’s attempt to cast Jewell’s “methodology” at such a high level of generality that any consideration of the many instances of methodological infidelity would be relegated to mere jury questions. Acquiescence in the PSC’s rhetorical move would constitute a complete abandonment of the inquiry whether Jewell had used a proper method. Pfizer at 15-16.

Interestingly, none of the amici curiae addressed the slippery WOE arguments advanced by the PSC. See generally Brief of Amici Curiae American Tort Reform Ass’n & Pharmaceutical Research and Manufacturers of America (Oct. 18, 2016); Brief of Washington Legal Fdtn. as Amicus Curiae (Oct. 18, 2016). There was no meaningful discussion of WOE as a supposedly scientific methodology at oral argument. See Transcript of Oral Argument in In re Zoloft Prod. Liab. Litig., No. 16-2247 (Jan. 25, 2017).

The Third Circuit Acknowledges that Some Methodological Infelicities, Flaws, and Fallacies Are Properly the Subject of Judicial Gatekeeping

Fortunately, Jewell’s methodological infidelities were easily recognized by the Circuit judges. Jewell treated multiple studies, which were nested within one another, and thus involved overlapping and included populations, as though they were independent verifications of the same hypothesis. When the population at issue (from the Danish cohort) was included in a more inclusive pan-Scandivanian study, the relied-upon association dissipated, and Jewell utterly failed to explain or account for these data. Zoloft at 5-6.

Jewell relied upon a study by Anick Bérard, even though he later had to concede that the study had serious flaws that invalidated its conclusions, and which flaws caused him to have a lack of confidence in the paper’s findings.² In another instance, Jewell relied innocently upon a study that purported to report a statistically significant association, but the authors of this paper were later required by the journal, The New England Journal of Medicine, to correct the very calculated confidence interval upon which Jewell had relied. Despite his substantial mathematical prowess, Jewell missed the miscalculation and relied (uncritically) upon a finding as statistically significant when in fact it was not.

Jewell rejected a meta-analysis of Zoloft studies for questionable methodological quibbles, even though he had relied upon the very same meta-analysis, with the same methodology, in his litigation efforts involving Prozac and birth defects. Not to be corralled by methodological punctilio, Jewell conducted his own meta-analysis with two studies Huybrechts (2014) and Jimenez-Solem (2012), but failed to explain why he excluded other studies, the inclusion of which would have undone his claimed result. Zoloft at 9. Jewell purported to reanalyze and recalculate point estimates in two studies, Jimenez-Solem (2012) and Huybrechts (2014), without any clear protocol or consistency in his approach to other studies. Zoloft at 9. The list goes on, but in sum, Jewell’s handling of these technical issues did not inspire confidence, either in the district or in the appellate court.

WOE to the Third Circuit

The Circuit gave the PSC every conceivable break. Because Pfizer had not engaged specifically on whether WOE was a proper, or any kind of, scientific method, the Circuit treated the issue as virtually conceded:

“Pfizer does not seem to contest the reliability of the Bradford Hill criteria or weight of the evidence analysis generally; the dispute centers on whether the specific methodology implemented by Dr. Jewell is reliable. Flexible methodologies, such as the “weight of the evidence,” can be implemented in multiple ways; despite the fact that the methodology is generally reliable, each application is distinct and should be analyzed for reliability.”

Zoloft at 18. The Court acknowledged that WOE arose only in the PSC’s appellate brief, which would have made the entire dubious argument waived under general appellate jurisdictional principles, but the Court, in a footnote, indulged the assumption, “for the sake of argument,” that WOE was Jewell’s purported method from the inception. Zoloft at 18 n. 39. Without any real evidentiary support or analysis or concession from Pfizer, the Circuit accepted that WOE analyses were “generally reliable.” Zoloft at 21.

The Circuit accepted, rather uncritically, that Jewell used a combination of WOE analysis and Bradford Hill considerations. Zoloft at 17. Although Jewell had never described WOE in his litigation report, and WOE was not a feature of his hearing testimony, the Circuit impermissibly engrafted Carl Cranor’s description of WOE as involving inference to the best explanation. Zoloft at 17 & n.37, citing Milward v. Acuity Specialty Prods. Grp., Inc., 639 F.3d 11, 17 (1st Cir. 2011) (internal quotation marks and citation omitted).

There was, however, a limit to the Circuit’s credulousness and empathy. As the Court noted, there must be some assurance that the purported Bradford Hill/WOE method is something more than a “mere conclusion-oriented selection process.” Zoloft at 20. Ultimately, the Court put its markers down for Jewell’s putative WOE methodology:

“there must be a scientific method of weighting that is used and explained.”

Zoloft at 20. Calling the method WOE did not, in the final analysis, exclude Jewell from Rule 702 gatekeeping. Try as the PSC might, there was just no mistaking Jewell’s approach as anything other than a crazy patchwork quilt of numerical wizardry in aid of subjective, result-oriented conclusion mongering.

In the Court’s words:

“we find that Dr. Jewell did not 1) reliably apply the ‘techniques’ to the body of evidence or 2) adequately explain how this analysis supports specified Bradford Hill criteria. Because ‘any step that renders the analysis unreliable under the Daubert factors renders the expert’s testimony inadmissible’, this is sufficient to show that the District Court did not abuse its discretion in excluding Dr. Jewell’s testimony.”

Zoloft at 28. As heartening as the Circuit’s conclusion is, the Court’s couching its observation as a finding (“we find”) is disheartening with respect to the Third Circuit’s apparent inability to distinguish abuse-of-discretion review from de novo appellate findings. Equally distressing is the Court’s invocation of Daubert factors, which were dicta in a Supreme Court case that was superseded by an amended statute over 17 years ago, in Federal Rule of Evidence 702.

On the crucial question whether Jewell had engaged in an unreliable application of methods or techniques that superficially, at a very high level of generality, claim to be generally accepted, the Court stayed on course. The Court “found” that Jewell had applied techniques, analyses, and critiques so obviously inconsistently that no amount of judicial indulgence, assumptions arguendo, or careless glosses could save Jewell and his fatuous opinions from judicial banishment. Zoloft 28-29. Returning to the correct standard of review (abuse of discretion), but the wrong governing law (Daubert instead of Rule 702), the Court announced that:

“[b]ecause ‘any step that renders the analysis unreliable under the Daubert factors renders the expert’s testimony inadmissible’, this is sufficient to show that the District Court did not abuse its discretion in excluding Dr. Jewell’s testimony.”

Zoloft at 21 n.50 (citation omitted). The Court found itself unable to say simply and directly that “the MDL trial court decided the case well within its discretion.”

The Zoloft case was not the Third Circuit’s first WOE rodeo. WOE had raised its unruly head in Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp. 2d 584, 602 (D.N.J. 2002), aff’d, 68 F. App’x 356 (3d Cir. 2003), where an expert witness, David Ozonoff, offered what purported to be a WOE opinion. The Magistrini trial court did not fuss with the assertion that WOE was generally reliable, but took issue with how Ozonoff tried to pass off his analysis as a comprehensive treatment of the totality of the evidence. In Magistrini, Judge Hochberg noted that regardless of the rubric of the methodology, the witness must show that in conducting a WOE analysis:

“all of the relevant evidence must be gathered, and the assessment or weighing of that evidence must not be arbitrary, but must itself be based on methods of science.”

Magistrini, 180 F. Supp. 2d at 602. The witness must show that the methodology is more than a “mere conclusion-oriented selection process,” and that it has a “a scientific method of weighting that is used and explained.” Id. at 607. Asserting the use of WOE was not an excuse or escape from judicial gatekeeping as specified by Rule 702.

Although the Third Circuit gave the Zoloft MDL trial court’s findings a searching review (certainly much tougher than the prescribed abuse-of-discretion review), the MDL court’s finding that Jewell “failed to consistently apply the scientific methods he articulates, has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion” were ultimately vindicated by the Court of Appeals. Zoloft at 10.

All’s well that ends well. Perhaps. It remains unfortunate, however, that a hypothetical method, WOE — which was never actually advocated by the challenged expert witnesses, which lacks serious support in the scientific community, and which was merely assumed arguendo to be valid — will be taken by careless readers to have been endorsed the Third Circuit.

1 Among the cases cited without any support for the PSC’s dubious contention were Gannon v. United States, 292 F. App’x 170, 173 n.1 (3d Cir. 2008); Bitler v. A.O. Smith Corp., 391 F.3d 1114, 1124-25 (10th Cir. 2004); In re Joint E. & S. Dist. Asbestos Litig., 52 F.3d 1124, 1128 (2d Cir. 1995); In re Avandia Mktg., Sales Practices & Prods. Liab. Litig., No. 2007-MD-1871, 2011 WL 13576, at *3 (E.D. Pa. Jan. 4, 2011) (“Bradford-Hill criteria are used to assess whether an established association between two variables actually reflects a causal relationship.”).

2 Anick Bérard, Sertraline Use During Pregnancy and the Risk of Major Malformations, 212 Am. J. Obstet. Gynecol. 795 (2015).

Posted in Expert Witnesses, Rule 702, Scientific Evidence, statistical evidence | Comments Off on WOE — Zoloft Escapes a MDL While Third Circuit Creates a Conceptual Muddle

Weight of the Evidence in Science and in Law

July 29th, 2017

“woe to that man by whom the offense cometh”

Matthew 18:7

Weight of the evidence (WOE) has cropped up again in recent trial and appellate court proceedings involving the admissibility of scientific expert witness opinion testimony. With some consistency, the WOE approach advocated is vacuous. The proponents of WOE do not specify what type of evidence is considered, whether all evidence was considered, or how competing and conflicting evidence was weighed.

Interpreted sympathetically, WOE might be taken to mean that “scientific judgment” was exercised with respect to causal inference, without describing exactly what was done. Although sympathetic, this interpretation renders the purported methodology meaningless. WOE-ful scientists might just as well say that they used scientific method. Not surprisingly, WOE is absent from virtually all major epidemiology textbooks

Despite the vacuity of WOE, or because of it, some lawyers, who constitute the lawsuit industry, are particularly fond of WOE.¹ Expert witnesses who support the lawsuit industry have defended their “right” to inflict WOE on the litigation system, tooth and nail.²

Carl Cranor, a philosophy professor and a hired expert witness in litigation for plaintiffs’ counsel, has written about WOE and attempted to defend WOE as a scientific methodology. Cranor has caricaturized criticisms of WOE, including mine, by suggesting that the International Agency for Research on Cancer’s use of WOE rebuts my suggestion that WOE is no method at all.³ Cranor’s defense fails, however, because IARC’s method, for all its deficiencies, never invokes a method mired in WOE.

Perhaps the Lawsuit Industry likes WOE as much as it likes the equally vague term, “link.” WOE frees them from the requirement of any meaningful methodology, which means that any conclusion is possible. Under WOE, any conclusion can survive gatekeeping as an opinion. WOE frees the putative expert witness from the need to consider the quality of research. WOE-ful authors such as Carl Cranor invoke WOE or seek to inflict WOE without mentioning the crucial “nuts and bolts” of scientific inference, such as concepts of

Internal and external validity
Assessment of random error
Assessment of known and residual confounding
Known and potential threats to validity in
Appropriate methods of systematic review
Appropriate synthesis across studies, such as systematic review and meta-analysis

These important concepts are lost in the miasma of WOE.

In the published scientific literature, it is a commonplace that WOE is either poorly or not defined and specified. The phrase is vague and ambiguous; its use, inconsistent.⁴ Even authors sympathetic to the WOE mission have reluctantly concluded that the term is most often used in a way that “does not lend itself to transparency or repeatability except in simple cases.”⁵

Another reason that WOE resonates so strongly with the Lawsuit Industry is that having expert witnesses proclaim WOE as their methodology permits trial counsel to claim that the proffered opinions are immune to gatekeeping because, after all, weight-of-the-evidence questions are for the jury. Lawyers learn early on about WOE factual issues in appellate review of a wide variety of evidentiary and sufficiency issues in criminal and civil cases.⁶ Unless against the great WOE, WOE questions are for the jury.

Even venerable judges fall for this semantic confusion. In 1995, the Second Circuit, before the major revision of Rule 702, in 2000, noted that in discharging their gatekeeping role, trial judges do not assume:

“‘the role of St. Peter at the gates of heaven, performing a searching inquiry into the depth of an expert witness’s soul’ that would ‘inexorably lead to evaluating witness credibility and weight of the evidence, the ageless role of the jury’.”

McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1045 (2d Cir.1995) (internal citations omitted).

Of course, the expert witness’s soul is not at issue, but his methodology is. More important, however, note how the appellate court adverted to “weight of the evidence” as something that the jury must evaluate, along with witness credibility. The expert witness WOE litigation strategy deliberately trades upon the confusion between WOE in the allocation between judge and jury, and valid scientific methodology in causal inference. McCullock is proof that judges can be, and are, bamboozled by the litigation strategy.

Twenty years after McCullock, federal appellate judges are still falling for the deliberate confusion between legal and scientific WOE. The Ninth Circuit recently held that the reliability test of Federal Rule of Evidence 702 is:

“‘is not the correctness of the expert’s conclusions but the soundness of his methodology’, and when an expert meets the threshold established by Rule 702, the expert may testify and the fact finder decides how much weight to give that testimony. Challenges that go to the weight of the evidence are within the province of a fact finder, not a trial court judge. A district court should not make credibility determinations that are reserved for the jury.”

City of Pomona v. SQM North America Corp., 750 F.3d 1036, 1044 (9th Cir. 2014) (internal citation omitted), cert. denied, 135 S. Ct. 870 (2014). Characterizing a methodological dispute as one that “merely” concerns the “weight of the evidence” is a strategy to remove the dispute from judicial gatekeeping altogether.

Recently, the Third Circuit displayed this confusion of WOE with methodological impropriety by mischaracterizing failure to correct for multiple testing as merely an improper calculation that ordinarily goes to the weight of the evidence, not its admissibility. Karlo v. Pittsburgh Glass Works, LLC, 849 F.3d 61, 83 (3d Cir. 2017).

The Third Circuit, in Karlo, cited to a Supreme Court case that predated Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), and which did involve any Rule 702 challenge to the use of a flawed statistical analysis. In Bazemore v. Friday, 478 U.S. 385, 400 (1986), plaintiffs sued as a class for employment discrimination, and sought to show the discrimination through the use of a regression analysis. The defense challenged the plaintiffs’ regression on grounds that key variables were omitted. The Court rejected a sufficiency challenge to a finding of discrimination in plaintiffs’ class action, and noted:

“Normally, failure to include variables will affect the analysis’ probativeness, not its admissibility.”

The lesson of the last two decades of judicial gatekeeping is that methodological infirmity will affect both probitiveness and admissibility⁷. Courts cannot escape their important gatekeeping duties by shifting their responsibility to juries under the guise of WOE.

1 See, e.g., “WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name” (May 1, 2012); “As They WOE, So No Recovery Have the Reeps,” (May 22, 2013).

2 See Schachtman, “Desultory Thoughts on Milward v. Acuity Specialty Products,” (Oct. 2015).

3 Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 146 (2d ed. 2016) (citing and selectively quoting from Schachtman, “WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name” (May 1, 2012)).

4 See Charles Menzie, Miranda Hope Henning, Jerome Cura, Kenneth Finkelstein, Jack Gentile, James Maughan, David Mitchell, Stephen Petron, Bonnie Potocki, Susan Svirsky & Patti Tyler, “A weight-of-evidence approach for evaluating ecological risks; report of the Massachusetts Weight-of-Evidence Work Group,” 2 Human Ecological Risk Assessment 277, 279 (1996) (“although the term ‘weight of evidence’ is used frequently in ecological risk assessment, there is no consensus on its definition or how it should be applied”); Sheldon Krimsky, “The weight of scientific evidence in policy and law,” 95 Am. J. Pub. Health S129 (2005) (“However, the term [WOE] is applied quite liberally in the regulatory literature, the methodology behind it is rarely explicated.”); V. H. Dale, G.R. Biddinger, M.C. Newman, J.T. Oris, G.W. Suter II, T. Thompson, et al., “Enhancing the ecological risk assessment process,” 4 Integrated Envt’l Assess. Management 306 (2008) (“An approach to interpreting lines of evidence and weight of evidence is critically needed for complex assessments, and it would be useful to develop case studies and/or standards of practice for interpreting lines of evidence.”); Douglas L. Weed, “Weight of Evidence: A Review of Concept and Methods,” 25 Risk Analysis 1545 (2005) (noting the “lack of definition of the term weight of evidence, multiple uses of the term and a lack of consensus about its meaning, and the many different kinds of weights, both qualitative and quantitative which can be used in risk assessment”); R.G. Stahl Jr., “Issues addressed and unaddressed in EPA’s ecological risk guidelines,” 17 Risk Policy Report 35 (1998) (noting that U.S. Environmental Protection Agency’s guidelines for ecological weight-of-evidence approaches to risk assessment fail to provide guidance); Glenn W. Suter, Susan M. Cormier, “Why and how to combine evidence in environmental assessments: Weighing evidence and building cases,” 409 Sci. Total Env’t 1406, 1406 (2011) (noting arbitrariness and subjectivity of WOE “methodology”).

5 See Igor Linkov, Drew Loney, Susan Cormier, F. Kyle Satterstrom, and Todd Bridges, “Weight-of-evidence evaluation in environmental assessment: review of qualitative and quantitative approaches,” 407 Sci. Total Env’t 5199, 5203 (2009).

6 See, e.g., People v. Collier, 146 A.D.3d 1146, 1147-48, 2017 NY Slip Op 00342 (N.Y. App. Div. 3d Dep’t, Jan. 19, 2017) (rejecting appeal based upon defendant’s claim that conviction was against “weight of the evidence”); Venson v. Altamirano, 749 F.3d 641, 656 (7th Cir. 2014) (noting “new trial is appropriate if the jury’s verdict is against the manifest weight of the evidence”).

7 David L. Faigman, Christopher Slobogin & John Monahan, “Gatekeeping Science: Using the Structure of Scientific Research to Distinguish Between Admissibility and Weight in Expert Testimony,” 110 Northwestern L. Rev. 859, 865 (2016) (“An expert economist in an employment discrimination case who admittedly fails to control for a key variable such as seniority or wage structure in a regression analysis has committed a general error that should lead to exclusion by a judge… .”).

Posted in Causation, Rule 702, Scientific Evidence | Comments Off on Weight of the Evidence in Science and in Law

Samuel Tarry’s Protreptic for Litigation-Sponsored Publications

July 9th, 2017

Litigation-related research has been the punching bag of self-appointed public health advocates for some time. Remarkably, and perhaps not surprising to readers of this blog, many of the most strident critics have deep ties to the lawsuit industry, and have served the plaintiffs’ bar loyally and zealously for many years.¹^,²^,³^,⁴ And many of these critics have ignored or feigned ignorance of the litigation provenance of much research that they hold dear, such as Irving Selikoff’s asbestos research undertaken for the asbestos workers’ union and its legal advocates. These critics’ campaign is an exquisite study in hypocrisy.

For some time, I have argued that the standards for conflict-of-interest disclosures should be applied symmetrically and comprehensively to include positional conflicts, public health and environmental advocacy, as well as litigation consulting or testifying for any party. Conflicts should be disclosed, but they should not become a facile excuse or false justification for dismissing research, regardless of the party that sponsored it.⁵ Scientific studies should be interpreted scientifically – that is carefully, thoroughly, and rigorously – regardless whether they are conducted and published by industry-sponsored, union-sponsored, or Lord help us, even lawyer-sponsored scientists.

Several years ago, a defense lawyer, Samuel Tarry, published a case series of industry-sponsored research or analysis, which grew out of litigation, but made substantial contributions to the scientific understanding of claimed health risks. See Samuel L. Tarry, Jr., “Can Litigation-Generated Science Promote Public Health?” 33 Am. J. Trial Advocacy 315 (2009). Tarry’s paper is a helpful corrective to the biased (and often conflicted) criticisms of industry-sponsored research and analysis by the lawsuit industry and its scientific allies and consultants. It an ocean of uninformative papers about “Daubert,” Tarry’s paper stands out and should be required reading for all lawyers who practice in the area of “health effects litigation.”

Tarry presented a brief summary of the litigation context for three publications that deserve to remembered and used as exemplars of important, sound, scientific publications that helped changed the course of litigations, as well as the scientific community’s appreciation of prior misleading contentions and publications. His three case studies grew out of the silicone-gel breast implant litigation, the latex allergy litigation, and the never-ending asbestos litigation.

1. Silicone

There are some glib characterizations of the silicone gel breast implant litigation as having had no evidentiary basis. A more careful assessment would allow that there was some evidence, much of it fraudulent and irrelevant. See, e.g., 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 the silicone gel breast implant litigation as “charlatans” and the litigation as largely based upon fraud). The lawsuit industry worked primarily through so-called support groups, which in turn funded friendly, advocate physicians, who in turn testified for plaintiffs and their lawyers in personal injury cases.

When the defendants, such as Dow Corning, reacted by sponsoring serious epidemiologic analyses of the issue whether exposure to silicone gel was associated with specific autoimmune or connective tissue diseases, the plaintiffs’ bar mounted a conflict-of-interest witch hunt over industry funding.⁶ Ultimately, the source of funding became obviously irrelevant; the concordance between industry-funded and all high quality research on the litigation claims was undeniable. Obvious that is to court-appointed expert witnesses⁷, and to a blue-ribbon panel of experts in the Institute of Medicine⁸.

2. Latex Hypersensitivity

Tarry’s second example comes from the latex hypersensitivity litigation. Whatever evidentiary basis may have existed for isolated cases of latex allergy, the plaintiffs’ bar had taken and expanded into a full-scale mass tort. A defense expert witness, Dr. David Garabrant, a physician and an epidemiologist, published a meta-analysis and systematic review of the extant scientific evidence. David H. Garabrant & Sarah Schweitzer, “Epidemiology of latex sensitization and allergies in health care workers,” 110 J. Allergy & Clin. Immunol. S82 (2002). Garabrant’s formal, systematic review documented his litigation opinions that the risk of latex hypersensitivity was much lower than claimed and not the widespread hazard asserted by plaintiffs and their retained expert witnesses. Although Garabrant’s review did not totally end the litigation and public health debate about latex, it went a long way toward ending both.

3. Fraudulent Asbestos-Induced Radiography

I still recall, sitting at my desk, my secretary coming into my office to tell me excitedly that a recent crop of silicosis claimants had had previous asbestosis claims. When I asked how she knew, she showed me the computer print out for closed files for another client. Some of the names were so distinctive that the probability that there were two men with the same name was minuscule. When we obtained the closed files from storage, sure enough, the social security numbers matched, as did all other pertinent data, except that what had been called asbestosis previously was now called silicosis.

My secretary’s astute observation was mirrored in the judicial proceedings of Judge Janis Graham Jack, who presided over MDL 1553. Judge Jack, however, discovered something even more egregious: in some cases, a single physician interpreted a single chest radiograph as showing either asbestosis or silicosis, but not both. The two, alternative diagnoses were recorded in two, separate reports, for two different litigation cases against different defendants. This fraudulent practice, as well as others, are documented in Judge Jack’s extraordinary, thorough opinion. See In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563 (S.D. Tex. 2005)⁹.

The revelations of fraud in Judge Jack’s opinion were not entirely surprising. As everyone involved in asbestos litigation has always known, there is a disturbing degree of subjectivity in the interpretation of chest radiographs for pneumoconiosis. The federal government has long been aware of this problem, and through the Centers for Disease Control and the National Institute of Occupational Safety and Health, has tried to subdue extreme subjectivity by creating a pneumoconiosis classification schemed for chest radiographs known as the “B-reader” system. Unfortunately, B-reader certification meant only that physicians could achieve inter-observer and intra-observer reproducibility of interpretations on the examination, but they were free to peddle extreme interpretations for litigation. Indeed, the B-reader certification system exacerbated the problem by creating a credential that was marketed to advance the credibility of some of the most biased, over-reading physicians in asbestos, silica, and coal pneumoconiosis litigation.

Tarry’s third example is a study conducted under the leadership of the late Joseph Gitlin, at Johns Hopkins Medical School. With funding from defendants and insurers, Dr. Joseph Gitlin conducted a concordance study of films that had been read by predatory radiologists and physicians as showing pneumoconiosis. The readers in his study found a very low level of positive films (less than 5%), despite their having been interpreted as showing pneumoconiosis by the litigation physicians. See Joseph N. Gitlin, Leroy L. Cook, Otha W. Linton, and Elizabeth Garrett-Mayer, “Comparison of ‘B’ Readers’ Interpretations of Chest Radiographs for Asbestos Related Changes,” 11 Acad. Radiol. 843 (2004); Marjorie Centofanti, “With thousands of asbestos workers demanding compensation for lung disease, a radiology researcher here finds that most cases lack merit,” Hopkins Medicine (2006). As with the Sokol hoax, the practitioners of post-modern medicine cried “foul,” and decried industry sponsorship, but the disparity between courtroom and hospital medicine was sufficient proof for most disinterested observers that there was a need to fix the litigation process.

Meretricious Mensuration¹⁰ – Manganese Litigation Example

Tarry’s examples are important reminders that corporate sponsorship, whether from the plaintiffs’ lawsuit industry or from manufacturing industry, does not necessarily render research tainted or unreliable. Although lawyers often confront exaggerated or false claims, and witness important, helpful correctives in the form of litigation-sponsored studies, the demands of legal practice and “the next case” typically prevent lawyers from documenting the scientific depredations and their rebuttals. Sadly, unlike litigations such as those involving Bendectin and silicone, the chronicles of fraud and exaggeration are mostly closed books in closed files in closed offices. These examples need the light of day and a fresh breeze to disseminate them widely in both the scientific and legal communities, so that all may have a healthy appreciation for the value of appropriately conducted studies generated in litigation contexts.

As I have intimated elsewhere, the welding fume litigation is a great example of specious claiming, which ultimately was unhorsed by publications inspired or funded by the defense. In the typical welding fume case, plaintiff claimed that exposure to manganese in welding fume caused Parkinson’s disease or manganism. Although manganism sounds as though it must be a disease that can be caused only by manganese, in the hands of plaintiffs’ expert witnesses, manganism became whatever ailment plaintiffs claimed to have suffered. Circularity and perfect definitional precision were achieved by semantic fiat.

The Sanchez-Ramos Meta-Analysis

Manganese Madness was largely the creation of the Litigation Industry, under the dubious leadership of Dickie Scruggs & Company. Although the plaintiffs enjoyed a strong tail wind in the courtroom of an empathetic judge, they had difficulties in persuading juries and ultimately decamped from MDL 1535, in favor of more lucrative targets. In their last hurrah, however, plaintiffs retained a neurologist, Juan Sanchez-Ramos, who proffered a biased, invalid synthesis, which he billed as a meta-analysis¹¹.

Sanchez-Ramos’s meta-analysis, such as it was, provoked professional disapproval and criticism from the defense expert witness, Dr. James Mortimer. Because the work product of Sanchez-Ramos was first disclosed in deposition, and not in his Rule 26 report, Dr. Mortimer undertook belatedly a proper meta-analysis.¹² Even though Dr. Mortimer’s meta-analysis was done in response to the Sanchez-Ramos’s improper, tardy disclosure, the MDL judge ruled that Mortimer’s meta-analysis was too late. The effect, however, of Mortimer’s meta-analysis was clear in showing that welding had no positive association with Parkinson’s disease outcomes. The MDL 1535 resolved quickly thereafter, and with only slight encouragement, Dr. Mortimer published a further refined meta-analysis with two other leading neuro-epidemiologists. See James Mortimer, Amy Borenstein, and Lorene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012). See also “Manganese Meta-Analysis Further Undermines Reference Manual’s Toxicology Chapter” (Oct. 15, 2012).

1 See, e.g., David Michaels & Celeste Monforton, “Manufacturing Uncertainty Contested Science and the Protection ofthe Public’s Health and Environment,” 95 Am. J. Pub. Health S39, S40 (2005); David Michaels & Celeste Monforton, “How Litigation Shapes the Scientific Literature: Asbestos and Disease Among Automobile Mechanics,” 15 J. L. & Policy 1137, 1165 (2007). Michaels had served as a plaintiffs’ paid expert witness in chemical exposure litigation, and Monforton had been employed by labor unions before these papers were published, without disclosure of conflicts.

2 Leslie Boden & David Ozonoff, “Litigation-Generated Science: Why Should We Care?” 116 Envt’l Health Persp. 121, 121 (2008) (arguing that systematic distortion of the scientific record will result from litigation-sponsored papers even with disclosure of conflicts of interest). Ozonoff had served as a hired plaintiffs’ expert witnesses on multiple occasion before the publication of this article, which was unadorned by disclosure.

3 Lennart Hardell, Martin J. Walker, Bo Walhjalt, Lee S. Friedman, and Elihu D. Richter, “Secret Ties to Industry and Conflicting Interest in Cancer Research,” 50 Am. J. Indus. Med. 227, 233 (2007) (criticizing “powerful industrial interests” for “undermining independent research on hazard and risk,” in a “red” journal that is controlled by allies of the lawsuit industry). Hardell was an expert witness for plaintiffs in mobile phone litigation in which plaintiffs claimed that non-ionizing radiation caused brain cancer. In federal litigation, Hardell was excluded as an expert witness when his proffered opinions were found to be scientifically unreliable. Newman v. Motorola, Inc., 218 F. Supp. 2d. 769, 777 (D. Md. 2002), aff’d, 78 Fed. Appx. 292 (4th Cir. 2003).

4 See David Egilman & Susanna Bohme, “IJOEH and the Critique of Bias,” 14 Internat’l J. Occup. & Envt’l Health 147, 148 (2008) (urging a Marxist critique that industry-sponsored research is necessarily motivated by profit considerations, and biased in favor of industry funders). Although Egilman usually gives a disclosure of his litigation activities, he typically characterizes those activities as having been for both plaintiffs and defendants, even though his testimonial work for defendants is minuscule.

5 Kenneth J. Rothman, “Conflict of Interest: The New McCarthyism in Science,” 269 J. Am. Med. Ass’n 2782 (1993).

6 See Charles H. Hennekens, I-Min Lee, Nancy R. Cook, Patricia R. Hebert, Elizabeth W. Karlson, Fran LaMotte; JoAnn E. Manson, and Julie E. Buring, “Self-reported Breast Implants and Connective- Tissue Diseases in Female Health Professionals: A Retrospective Cohort Study, 275 J. Am. Med. Ass’n 616-19 (1998) (analyzing established cohort for claimed associations, with funding from the National Institutes of Health and Dow Corning Corporation).

7 See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998).” The court-appointed expert witnesses dedicated a great deal of their professional time to their task of evaluating the plaintiffs’ claims and the evidence. At the end of the process, they all published their litigation work in leading journals. See Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000); Esther C. Janowsky, Lawrence L. Kupper., and Barbara S. Hulka, “Meta-Analyses of the Relation between Silicone Breast Implants and the Risk of Connective-Tissue Diseases,” 342 New Engl. J. Med. 781 (2000); Peter Tugwell, George Wells, Joan Peterson, Vivian Welch, Jacqueline Page, Carolyn Davison, Jessie McGowan, David Ramroth, and Beverley Shea, “Do Silicone Breast Implants Cause Rheumatologic Disorders? A Systematic Review for a Court-Appointed National Science Panel,” 44 Arthritis & Rheumatism 2477 (2001).

8 Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

9 See also Lester Brickman, “On the Applicability of the Silica MDL Proceeding to Asbestos Litigation, 12 Conn. Insur. L. J. 289 (2006); Lester Brickman, “Disparities Between Asbestosis and Silicosis Claims Generated By Litigation Screenings and Clinical Studies,” 29 Cardozo L. Rev. 513 (2007).

10 This apt phraseology is due to the late Keith Morgan, whose wit, wisdom, and scientific acumen are greatly missed. See W. Keith C. Morgan, “Meretricious Mensuration,” 6 J. Eval. Clin. Practice 1 (2000).

11 See Deposition of Dr. Juan Sanchez-Ramos, in Street v. Lincoln Elec. Co., Case No. 1:06-cv-17026, 2011 WL 6008514 (N.D. Ohio May 17, 2011).

12 See Deposition of Dr. James Mortimer, in Street v. Lincoln Elec. Co., Case No. 1:06-cv-17026, 2011 WL 6008054 (N.D. Ohio June 29, 2011).

Posted in Asbestos, Causation, Conflicts of Interest, Meta-analysis, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Samuel Tarry’s Protreptic for Litigation-Sponsored Publications

Every Time a Bell Rings

July 1st, 2017

“Every time a bell rings, an angel gets his wings.”
Zuzu Bailey

And every time a court issues a non-citable opinion, a judge breaks fundamental law. Whether it wants to or not, a common law court, in deciding a case, creates precedent, and an expectation and a right that other, similarly situated litigants will be treated similarly. Deciding a case and prohibiting its citation deprives future litigants of due process and equal protection of the law. If that makes for more citable opinions, more work for judges and litigants, so be it; that is what our constitution requires.

Back in 2015, Judge Bernstein issued a ruling in a birth defects case in which the mother had claimed to have taken sertraline during pregnancy and this medication use caused her child to be born with congenital malformations. Applying what Pennsylvania courts insist is a Frye standard, Judge Bernstein excluded the proffered expert witness testimony that attempted to draw a causal connection between the plaintiff’s birth defect and the mother’s medication use. Porter v. SmithKline Beecham Corp., No. 03275, 2015 WL 5970639 (Phila. Cty. Pennsylvania, Ct. C.P. October 5, 2015) (Mark I. Bernstein, J.) Judge Bernstein has since left the bench, but he was and is a respected commentator on Pennsylvania evidence¹, even if he was generally known for his pro-plaintiff views on many legal issues. Bernstein’s opinion in Porter was a capable demonstration of how Pennsylvania’s Frye rule can be interpreted to reach essentially the same outcome that is required by Federal Rule of Evidence 702. See “Demonstration of Frye Gatekeeping in Pennsylvania Birth Defects Case” (Oct. 6, 2015); In re Zoloft Prod. Liab. Litig., No. 16-2247 , __ F.3d __, 2017 WL 2385279 , 2017 U.S. App. LEXIS 9832 (3d Cir. June 2, 2017) (affirming exclusion of dodgy statistical analyses and opinions, and the trial court’s entry of summary judgment on claims that sertraline causes birth defects).

In May of this year, the Pennsylvania Superior Court affirmed Judge Bernstein’s judgment, and essentially approved and adopted his reasoning. Porter v. SmithKline Beecham Corp., No. 3516 EDA 2015,2017 WL 1902905 (Pa. Super. May 8, 2017). What the Superior Court purport to giveth, the Superior Court taketh away. The Porter decision is franked as a “Non-Precedential Decision – See Superior Court I.O.P. 65.37.”

What is this Internal Operating Procedure that makes the Superior Court think that it can act and decide cases without creating precedent? Here is the relevant text from the Pennsylvania Code:

An unpublished memorandum decision shall not be relied upon or cited by a Court or a party in any other action or proceeding, except that such a memorandum decision may be relied upon or cited

when it is relevant under the doctrine of law of the case, res judicata, or collateral estoppel, and

when the memorandum is relevant to a criminal action or proceeding because it recites issues raised and reasons for a decision affecting the same defendant in a prior action or proceeding.

210 Pa. Code § 65.37. Unpublished Memoranda Decisions. So, in other words, it is secret law.

No citation and no precedent rules are deeply problematic, and have attracted a great deal of scholarly attention². And still, courts engage in this problematic practice. Prohibiting citation of Superior Court decisions in Pennsylvania is especially problematic in a state in which the highest court hears relatively few cases, and where the Justices involve themselves in internecine disputes. As other commentators have noted, prohibiting citation to prior decisions admitting or excluding expert witness testimony stunts the development of an area of evidence law, in which judges and litigants are often confused and in need of guidance. William E. Padgett, “‘Non-Precedential’ Unpublished Decisions in Daubert and Frye Cases, Often Silenced,” Nat’l L. Rev. (2017). The abuses of judge-made secret law from uncitable decisions has been abolished in the federal appeals courts for over a decade³. It is time for the state courts to follow suit.

1 See, e.g., Mark I. Bernstein, Pennsylvania Rules of Evidence (2017).

2 See Erica Weisgerber, “Unpublished Opinions: A Convenient Means to an Unconstitutional End,” 97 Georgetown L.J. 621 (2009); Rafi Moghadam, “Judge Nullification: A Perception of Unpublished Opinions,” 62 Hastings L.J. 1397 (2011); Norman R. Williams, “The failings of Originalism: The Federal Courts and the Power of Precedent,” 37 U.C.. Davis L. Rev.761 (2004); Dione C. Greene, “The Federal Courts of Appeals, Unpublished Decisions, and the ‘No-Citation Rule,” 81 Indiana L.J. 1503 (2006); Vincent M. Cox, “Freeing Unpublished Opinions from Exile: Going Beyond the Citation Permitted by Proposed Federal Rule of Appellate Procedure 32.1,” 44 Washburn L.J. 105 (2004); Sarah E. Ricks, “The Perils of Unpublished Non-Precedential Federal Appellate Opinions: A Case Study of The Substantive Due Process State-Created Danger Doctrine in One Circuit,” 81 Wash. L.Rev. 217 (2006); Michael J. Woodruff, “State Supreme Court Opinion Publication in the Context of Ideology and Electoral Incentives.” New York University Department of Politics (March 2011); Michael B. W. Sinclair, “Anastasoff versus Hart: The Constitutionality and Wisdom of Denying Precedential Authority to Circuit Court Decisions”; Thomas Healy, “Stare Decisis as a Constitutional Requirement,” 104 W. Va. L. Rev. 43 (2001); David R. Cleveland & William D. Bader, “Precedent and Justice,” 49 Duq. L. Rev. 35 (2011); Johanna S. Schiavoni, “Who’s Afraid of Precedent,” 49 UCLA L. Rev. 1859 (2002); Salem M. Katsh and Alex V. Chachkes, “Constitutionality of ‘No-Citation’ Rules,” 3 J. App. Prac. & Process 287 (2001); David R. Cleveland, “Appellate Court Rules Governing Publication, Citation, and Precedent of Opinions: An Update,” 16 J. App. Prac. & Process 257 (2015). See generally The Committee for the Rule of Law (website) (collecting scholarship and news on the issue of unpublished and supposedly non-precedential opinions). The problem even has its own Wikipedia page. See “Non-publication of legal opinions in the United States.”

3 See Fed. R. App. Proc. 32.1 (prohibiting federal courts from barring or limiting citation to unpublished federal court opinions, effective after Jan. 1, 2007).

Posted in Causation, Expert Witnesses, Frye, Rule 702 | Comments Off on Every Time a Bell Rings

Talc Litigation Supported by Slippery Expert Witness

April 25th, 2017

Another day, another talc trial in Missouri. This one involves Lois Slemp, who sued Johnson & Johnson and its talc supplier, Imerys Talc America Inc., on her claim that her long-term use of talc caused her to develop borderline ovarian cancer.

To support her causal claim, Slemp’s lawyers called upon Dr. Daniel Cramer, a gynecologist and epidemiologist, from Harvard, to testify. See Daniel Siegal, “J & J’s Talc Caused Woman’s Cancer, Harvard MD Tells Jury,” Law360 (April 24, 2017) [cited as Siegel]. At first blush, counsel’s retention of Dr. Cramer seems like a brilliant choice. Cramer is a Professor of Epidemiology, at Harvard University’s T.H. Chan School Of Public Health, and a Professor of Obstetrics, Gynecology and Reproductive Biology, at Harvard Medical School. For over 30 years, Cramer has published primary studies, reviews, and commentary pieces in which he has addressed the epidemiologic and biological evidence involving talc and ovarian cancer.¹

Cramer, as both a physician and an epidemiologist, addressed both general and specific causation in the Slemp case. Notwithstanding Slemp’s risk factors of family history of cancer and obesity, Cramer asserted with “reasonable degree of medical and scientific certainty” that talc was “the major contributing cause and substantial cause in the development of her serious borderline tumor.” Siegel, supra.

Somehow this physician epidemiologist has taken a putative risk factor and converted it into the cause. This conversion would perhaps make sense if the risk factor were necessary or sufficient to cause the outcome, but the evidence involving talc and ovarian cancer does not even remotely resemble such a situation. The epidemiologic evidence is weak and inconsistent, but if causation were assumed on the basis of cherry-picked studies, the relative risk for ovarian cancer would be somewhere around 1.2. Somewhat like the magic grits in My Cousin Vinny, Dr. Cramer has found a putative risk factor that blocks out all other risk factors, including the idiopathic, baseline risks that afflict all women in the age range of Ms. Slemp.

On cross-examination, Cramer was confronted with his failure to have asserted general causation in his professional, peer-reviewed publications on talc and ovarian cancer. Defense counsel Orlando Richmond drew the jury’s attention to an invidious comparison between Cramer’s courtroom assertions and his epistemically more modest conclusions and qualifications in the scientific literature, in which he never claimed a causal relationship between talc use and ovarian cancer:

Q. “Nowhere in the published scientific literature, did you or your colleagues, ever publish, ever publish, that genital talc use causes serious borderline tumors, the disease Ms. Slemp has. Isn’t that a correct statement, sir?”

A. “We certainly made a powerful case for there being an association. We may not have used the word ‘causal,’ if I had known how important that word was, I would have used it a long time ago.”

Siegel.

Wow! A Harvard professor of medicine and epidemiology, who teaches at the Harvard School of Public Health, and who labored in the field of epidemiology for over three decades, was unaware until earlier this week, when he darkened the doorway of a Missouri courtroom, that there was an important distinction between association and causation, and this distinction was crucial to discussions and debates in science and public policy.

Now that is slipperier than the most lubricious talc dusting. Why would such an accomplished physician scientist equivocate so? Perhaps Cramer refrained from drawing a causal conclusion because uncertainty favored obtaining future grants to study the same issue. Maybe he refrained from drawing a causal conclusion because doing so would have made him subject to criticism, ridicule, and rebuttal from his professional colleagues. I cannot think of a flattering reason for Cramer’s timidity in expressing himself clearly to his professional peers over the course of 34 years of researching the issues.

Previously, I have called attention to “white hat” bias in the courtroom, which occurs when scientists enter the fray based upon their distorted perceptions of siding with the “little guy” in a misguided quest for social justice. Cramer’s participation in the litigation process illustrates another kind of bias in play in courtrooms. After 30 years of publishing on talc and ovarian cancer, Cramer has failed to obtain acceptance of a claim for causality from the scientific community, but the courtroom is a venue where he can obtain the approving judgment of a scientifically naïve jury or judge and thus gain some vindication for his work that has gone unappreciated by professional colleagues and policy makers.

1 See, e.g., Daniel W. Cramer, et al., “The Association Between Talc Use and Ovarian Cancer: A Retrospective Case-Control Study in Two U.S. States,” 27 Epidemiology 334 (2016); Daniel W. Cramer, “The epidemiology of endometrial and ovarian cancer,” 26 Hematol. Oncol. 1 (2012); M. A. Gates, Daniel W. Cramer, et al., “Talc use, variants of the GSTM1, GSTT1, and NAT2 genes, and risk of epithelial ovarian cancer,” 17 Cancer Epidemiol. Biomarkers Prevention 2436 (2008); Joshua Muscat, M. Huncharek, and Daniel W. Cramer, “Talc and anti-MUC1 antibodies,” 14 Cancer Epidemiol Biomarkers Prevention 2679 (2005); Daniel W. Cramer, et al., “Presence of talc in pelvic lymph nodes of a woman with ovarian cancer and long-term genital exposure to cosmetic talc,” 110 Obstet. & Gynecol. 498 (2007); D. M. Gertig, Daniel W. Cramer, Graham A. Colditz, et al., “Prospective study of talc use and ovarian cancer,” 92 J. Nat’l Cancer Inst. 249 (2000); Daniel W. Cramer, “Perineal talc exposure and subsequent epithelial ovarian cancer: a case-control study,” 94 Obstet. & Gynecol. 160 (1999); Daniel W. Cramer, et al., “Genital talc exposure and risk of ovarian cancer,” 81 Internat’l J. Cancer 351 (1999); Bernard L. Harlow, Daniel W. Cramer, et al., “Perineal exposure to talc and ovarian cancer risk,” 80 Obstet. & Gynecol. 19 (1992); Daniel W. Cramer, et al., “Ovarian cancer and talc: a case-control study, 50 Cancer 372 (1982).

Posted in Causation, Rule 702, Scientific Evidence | Comments Off on Talc Litigation Supported by Slippery Expert Witness

Traditional, Frequentist Statistics Still Hegemonic

March 25th, 2017

The Defense Fallacy

In civil actions, defendants, and their legal counsel sometimes argue that the absence of statistical significance across multiple studies requires a verdict of “no cause” for the defense. This argument is fallacious, as can be seen where there are many studies, say eight or nine, which all consistently find elevated risk ratios, but with p-values slightly higher than 5%. The probability that eight studies, free of bias, would consistently find an elevated risk ratio, regardless of the individual studies’ p-values, is itself very small. If the studies were amenable to meta-analysis, the summary estimate of the risk ratio would itself likely be highly statistically significant in this hypothetical.

The Plaintiffs’ Fallacy

The plaintiffs’ fallacy derives from instances, such as the hypothetical one above, in which statistical significance, taken as a property of individual studies, is lacking. Even though we can hypothesize such instances, plaintiffs fallaciously extrapolate from them to the conclusion that statistical significance, or any other measure of sampling estimate precision, is unnecessary to support a conclusion of causation.

In courtroom proceedings, epidemiologist Kenneth Rothma n is frequently cited by plaintiffs as having shown or argued that statistical significance is unimportant. For instance, in the Zoloft multi-district birth defects litigation, plaintiffs argued in a motion for reconsideration of the exclusion of their epidemiologic witness that the trial court had failed to give appropriate weight to the Supreme Court’s decision in Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27 (2011), as well as to the Third Circuit’s invocation of the so-called “Rothman” approach in a Bendectin birth defects case, DeLuca v. Merrell Dow Pharms., Inc., 911 F.2d 941 (3d Cir. 1990). According to the plaintiffs’ argument, their excluded epidemiologic witness, Dr. Anick Bérard, had used this approach in arriving at her novel conclusion that sertraline causes virtually every kind of birth defect.

The Zoloft plaintiffs did not call Rothman as a witness; nor did they even present an expert witness to explain what Rothman’s arguments were. Instead, the plaintiffs’ counsel, sneaked in some references and vague conclusions into their cross-examinations of defense expert witnesses, and submitted snippets from Rothman’s textbook, Modern Epidemiology.

If plaintiffs had called Dr. Rothman to testify, he would have probably insisted that statistical significance is not a criterion for causation. Such insistence is not as helpful to plaintiffs in cases such as Zoloft birth defects cases as their lawyers might have thought or hoped. Consider for instance the cases in which causal inferences are arrived at without formal statistical analysis. These instances are often not relevant to mass tort litigation that involve prevalent exposure and a prevalent outcome.

Rothman also would have likely insisted that consideration of random variation and bias are essential to the assessment of causation, and that many apparently or nominally statistically significant associations do not and cannot support valid inferences of causation. Furthermore, he might have been given the opportunity to explain that his criticisms of significance testing are as much directed to the creation of false positive as to false negative rates in observational epidemiology. In keeping with his publications, Rothman would have challenged strict significance testing with p-values as opposed to the use of sample statistical estimates in conjunction with confidence intervals. The irony of the Zoloft case and many other litigations was that the defense was not using significance testing in the way that Rothman had criticized; rather the plaintiffs were over-endorsing statistical significance that was nominal, plagued by multi-testing, and inconsistent.

Judge Rufe, who presided over the Zoloft MDL, pointed out that the Third Circuit in DeLuca had never affirmatively endorsed Professor Rothman’s “approach,” but had reversed and remanded the Bendectin case to the district court for a hearing under Rule 702:

“by directing such an overall evaluation, however, we do not mean to reject at this point Merrell Dow’s contention that a showing of a .05 level of statistical significance should be a threshold requirement for any statistical analysis concluding that Bendectin is a teratogen regardless of the presence of other indicia of reliability. That contention will need to be addressed on remand. The root issue it poses is what risk of what type of error the judicial system is willing to tolerate. This is not an easy issue to resolve and one possible resolution is a conclusion that the system should not tolerate any expert opinion rooted in statistical analysis where the results of the underlying studies are not significant at a .05 level.”

2015 WL 314149, at *4 (quoting from DeLuca, 911 F.2d at 955). And in DeLuca, after remand, the district court excluded the DeLuca plaintiffs’ expert witnesses, and granted summary judgment, based upon the dubious methods employed by plaintiffs’ expert witnesses (including the infamous Dr. Done, and Shanna Swan), in cherry picking data, recalculating risk ratios in published studies, and ignoring bias and confounding in studies. On subsequent appeal, the Third Circuit affirmed the judgment for Merrell Dow. DeLuca v. Merrell Dow Pharma., Inc., 791 F. Supp. 1042 (3d Cir. 1992), aff’d, 6 F.3d 778 (3d Cir. 1993).

Judge Rufe similarly rebuffed the plaintiffs’ use of the Rothman approach, their reliance upon Matrixx, and their attempt to banish consideration of random error in the interpretation of epidemiologic studies. In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342; 12-md-2342, 2015 WL 314149 (E.D. Pa. Jan. 23, 2015) (Rufe, J.) (denying PSC’s motion for reconsideration). See “Zoloft MDL Relieves Matrixx Depression” (Feb. 4, 2015).

Some Statisticians’ Errors

Recently, Dr. Rothman and three other epidemiologists set out to track the change, over time, from 1975 to 2014, of the use of various statistical methodologies. Andreas Stang, Markus Deckert, Charles Poole & Kenneth J. Rothman, “Statistical inference in abstracts of major medical and epidemiology journals 1975–2014: a systematic review,” 32 Eur. J. Epidem. 21 (2017) [cited below as Stang]. They made clear that their preferred methodological approach was to avoid the strictly dichotomous null hypothesis significance testing (NHST), which has evolved from Fisher’s significance testing and Neyman’s null hypothesis testing (NHT), in favor of the use of estimation with confidence intervals (CI). The authors conducted a meta-study, that is a study of studies, to track the trends in use of NHST, ST, NHT and CI reporting in the major bio-medical journals.

Unfortunately, the authors limited their data and analysis to abstracts, which makes their results very likely misleading and incomplete. Even when abstracts reported using so-called CI-only approaches, the authors may well have reasoned that point estimates with CIs that spanned no association were “non-significant.” Similarly, authors who found elevated risk ratios with very wide confidence intervals may well have properly acknowledged that their study did not provide credible evidence of an association. See W. Douglas Thompson, “Statistical criteria in the interpretation of epidemiologic data,” 77 Am. J. Public Health 191, 191 (1987) (discussing the over-interpretation of skimpy data).

Rothman and colleagues found that while a few epidemiologic journals had a rising prevalence of CI-only reports in abstracts, for many biomedical journals the NHST approach remained more common. Interestingly, at three of the major clinical medical journals, the Journal of the American Medical Association, the New England Journal of Medicine, and Lancet, the NHST has prevailed over the almost four decades of observation.

The clear implication of Rothman’s meta-study is that consideration of significance probability, whether or not treated as a dichotomous outcome, and whether or not treated as a p-value or a point estimate with a confidence interval, is absolutely critical to how biomedical research is conducted, analyzed, and reported. In Rothman’s words:

“Despite the many cautions, NHST remains one of the most prevalent statistical procedures in the biomedical literature.”

Stang at 22. See also David Chavalarias, Joshua David Wallach, Alvin Ho Ting & John P. A. Ioannidis, “Evolution of Reporting P Values in the Biomedical Literature, 1990-2015,” 315 J. Am. Med. Ass’n 1141 (2016) (noting the absence of the use of Bayes’ factors, among other techniques).

There is one aspect to the Stang article that is almost Trump-like in its citing to an inappropriate, unknowledgable source and then treating its author as having meaningful knowledge of the subject. As part of their rhetorical goals, Stang and colleagues declare that:

“there are some indications that it has begun to create a movement away from strict adherence to NHT, if not to ST as well. For instance, in the Matrixx decision in 2011, the U.S. Supreme Court unanimously ruled that admissible evidence of causality does not have to be statistically significant [12].”

Stang at 22. Whence comes this claim? Footnote 12 takes us to what could well be fake news of a legal holding, an article by a statistician about a legal case:

Joseph L. Gastwirth, “Statistical considerations support the Supreme Court’s decision in Matrixx Initiatives v. Siracusano, 52 Jurimetrics J. 155 (2012).

Citing a secondary source when the primary source is readily available, and what is at issue, seems like poor scholarship. Professor Gastwirth is a statistician, not a lawyer, and his exegesis of the Supreme Court’s decision is wildly off target. As any first year law student could discern, the Matrixx case could not have been about the admissibility of evidence because the case had been dismissed on the pleadings, and no evidence had ever been admitted or excluded. The only issue on appeal was the adequacy of the allegations, not the admissibility of evidence.

Although the Court managed to muddle its analysis by wandering off into dicta about causation, the holding of the case is that alleging causation was not required to plead a case of materiality for a securities fraud case. Having dispatched causality from the case, the Court had no serious business in setting the considerations for alleging in pleadings or proving at trial the elements of causation. Indeed, the Court made it clear that its frolic and detour into causation could not be taken seriously:

“We need not consider whether the expert testimony was properly admitted in those cases [cited earlier in the opinion], and we do not attempt to define here what constitutes reliable evidence of causation.”

Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 131 S.Ct. 1309, 1319 (2011).

The word “admissible” or “admissibility” never appear in the Court’s opinion, and the above quote explains that the admissibility was not considered. Laughably, the Court went on to cite three cases as examples of supposed causation opinions in the absence of statistical significance. Two of the three were specific causation, differential etiology cases that involved known general causation. The third case involved a claim of birth defects from contraceptive jelly, when the plaintiffs’ expert witnesses actually relied upon statistically significant (but thoroughly flawed and invalid) associations.¹

When it comes to statistical testing the legal world would be much improved if lawyers actually and carefully read statistics authors, and if statisticians and scientists actually read court opinions.

1 See “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1”; “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 2”; “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 3”; “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 4”; “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 5”; and “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 6”

Posted in Rule 702, statistical evidence | Comments Off on Traditional, Frequentist Statistics Still Hegemonic

Science Day Should Be Every Day in Our Courtrooms — Part II

March 24th, 2017

This post and the previous one are an expansion upon a post that I wrote with Dr. David Schwartz, of Innovative Science Solutions, LLC. Dr. Schwartz is a talented scientist with whom I had the privilege and pleasure to work at McCarter & English, before he left to become an independent scientific consultant. Dr. Schwartz is one of the founding partners of his firm, which focuses on helping lawyers with the scientific issues in complex health effects litigation. Our earlier post can be found on the Courtroom View Network’s website. “Guest Analysis: Key Takeaways from Recent Talc Powder ‘Science Day’ Hearing in California,” Courtroom View Network (Mar 24, 2017).

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Talc Science Goes Bicoastal

This year, two trial judges have entertained Science Days in talc cases, on both coasts of the United States. In the federal talc litigation, MDL 2738,¹ Judge Freda L. Wolfson conducted a Science Day on January 26, 2017. In the coordinated California state court talc cases, Judge Maren E. Nelson, of the Superior Court of California, Los Angeles County, conducted a Science Day, on March 7, 2017.²

Federal Talc MDL 2738

In the federal cases, Johnson & Johnson, one of the defendants, initiated the Science Day, in November 2016, when it asked Judge Wolfson to set aside a day in “which the parties and their experts can outline their positions/arguments regarding the medical and science issues at play.”³ In Case Management Order No. 1 (Jan. 23, 2017), Judge Wolfson apparently agreed, and the parties had their talc Science Day on January 26, 2017.⁴ The Science Day took up over five hours of presentations to Judge Freda L. Wolfson, and Judge Lois H. Goodman.⁵

California Coordinated Docket

In the California cases,⁶ plaintiffs’ counsel filed a formal motion, in early December 2016, to request a Science Day tutorial. The plaintiffs’ motion requested that each side be permitted two hours to present their views of the scientific evidence in support of their litigation positions on causation and liability in talc ovarian cancer cases. The plaintiffs argued that a Science Day would be “significant benefit to the Court and the parties.”⁷ Judge Nelson granted the request, and held Science Day on March 7, 2017.

Courtroom View Network (CVN)

The proceedings in California were recorded videographically, and are available through Courtroom View Network (CVN). Johnson & Johnson opposed televising the Science Day proceedings, on the procedural ground that CVN had not filed and served the appropriate motion. Johnson & Johnson also argued a substantive ground that the proceedings were not a formal trial, and that televising “would not confer any benefit on the public, the parties, or the Court, let alone one that outweighs the significant concerns posed by such a broadcast.”⁸

Whatever the merits of J & J’s procedural ground, its substantive grounds seem dubious. The importance of the Science Day proceedings transcends the pecuniary interests of the parties to the litigation. First, the presentations provide the empirical bases for other courts and lawyer to evaluate the procedures employed. Second, lawyers and judges generally, outside the talc litigation, can learn a great deal from the strengths, weaknesses, and mistakes made by the participants in the televised proceedings. Many of the scientific issues that pervade the talc litigation recur frequently in other mass tort litigations in the United States and abroad. Finally, and perhaps most important, the talc litigation involves litigation claims of huge import to the public generally. For better or worse, litigation has become an adjunct to regulation in the United States. If the plaintiffs’ claims are true, then there has been a serious failure of national and international regulatory agencies and scientific organizations in evaluating the evidentiary record. If the defendants’ claims are true, then the plaintiffs’ lawyers have misunderstood and distorted the basic process of synthesizing evidence and arriving at conclusions of causation. More important, it behooves the public to understand why one side is wrong.

Evaluation of the California Talc Litigation Science Day

Plaintiffs’ Presentations

The presentation by the plaintiff lawyers was eerily reminiscent of the scientific case made by plaintiffs in the silicone breast implant ligation. Their arguments ranged from highlighting anecdotal evidence to emphasizing the implicit sinister nature of talc migration from the vaginal opening to the ovaries. Plaintiff counsel focused heavily on the alleged role of talc in the inflammatory process and strong (unsubstantiated) implications that anything that enhances inflammation must necessarily cause cancer.

As one would expect, plaintiff counsel placed strong emphasis on the published epidemiological studies linking talc exposure to ovarian cancer. It is important to highlight that the majority of the studies showing an association between talc and ovarian cancer came from case-control studies by design (as opposed to a cohort design). Plaintiff counsel offered very little distinction between these two study designs and, instead tried to make the case that the sheer volume of studies made their argument..

Finally, it should be noted that at many times throughout the plaintiff presentations, the presenter veered off into non-scientific, ad hominem attacks against the industry and/or activities that they tried to paint as venal or unseemly. Defense counsel made objections throughout that seemed to be based upon first amendment protections for the defendants’ ability to speak to agencies about the scientific evidence. For example, the last presenter for the plaintiffs described alleged industry “lobbying” efforts at NTP. Defense counsel objected on first amendment grounds, and the judge semi-sustained the objection on the basis that it had little or nothing to do with the science. The plaintiffs’ emphasis on “lobbying” contained no examples of misrepresentations of scientific data. See “Talc Litigation in Missouri – Show Me the Law and the Evidence” (Feb. 24, 2017).

Defendants’ Presentations

In general, the defense presentations were more structured, coherent, substantial, and rigorously scientific. For example, unlike the plaintiffs’ graphics, many of the defense slides could stand on their own in a scientific or medical society presentation. The defense lawyers attempted to provide a solid foundation for the judge on the different types of ovarian cancer as well as the myriad uncertainties that exist in terms of the known causes of the condition. Many of the slides contained direct quotes from notable scientists and regulators on topics that were directly relevant to answering critical questions in the litigation.

Epidemiology and Specific Causation

Nevertheless, the defense presentations were not without their problems. Consider the following quote from an article by Graham Colditz, used in one of the defense powerpoint slides:⁹

“The fundamental object of epidemiology is to estimate the population average risk of the disease. Risk is a population measure, not an individual disease measure.”

Colditz has served as an expert witness on epidemiology for plaintiffs in talc and other litigations, and the defense no doubt believed that they could make their point in a rhetorically powerful way by quoting him. The problem starts with the quote’s failure to make the defense’s point. Risk is a measure or relative proportions in the sample, to be used to estimate the population measure. To say that it is a group measure, however, does not mean that there are no reasonable inferences from the group measure to the individual member of the sample or population.

The defense seems to want to argue that even there were an increased risk not explained by chance, bias, or confounding, that measure of risk does not tell us anything about what caused an individual claimant’s ovarian cancer.

A fuller quotation might even have helped the defense because Colditz seems intent on undermining not just the use of group measures of risk as an individual variable, but also the use of the measure to support an inference about individuals:

“The fundamental object of epidemiology is to estimate the population average risk of disease. Risk is a population measure, not an individual measure. Epidemiology does not estimate individual levels of risk, nor does it perfectly predict individual likelihood of disease. As noted by Rose, epidemiology does not describe why an individual case of cancer arises in the population but rather the population burden of cancer.¹⁴ In his article in this issue of the Journal, Begg ignores this principle and uses the term “risk” as an individual-level variable.¹⁵”

The fuller quotation points to a disagreement in which another epidemiologist was willing to use risk to describe individual attribute, but more to the point is that Colditz’s assertion is that risk is a group measure.

Colditz, at least in this article, does not claim that the group measure of risk was irrelevant to prospective individual predictions or retrospective individual attributions. Interestingly, Graham Colditz has elsewhere asserted that an increased risk of disease cannot be translated into the “but-for” standard of causation¹⁰:

“Knowledge that a factor is associated with increased risk of disease does not translate into the premise that a case of disease will be prevented if a specific individual eliminates exposure to that risk factor. Disease pathogenesis at the individual level is extremely complex.”

Defense may have wanted to highlight this assertion even recognizing that it is controversial, and quite dependent upon the magnitude of the measured risk.

In attempting to make their point with a quote from plaintiffs’ own expert (Dr. Graham Colditz), the defense oversimplified a much more complex issue. While increased or relative risk is indeed a measure or incidence rates used to estimate rates in the broader population, this aspect of relative risk as a measure does not mean that there are no reasonable inferences that can be made from the group measure to the individual member of the sample or population. The defense seems to want to make the seemingly unreasonable point that even if an increased risk were appropriately demonstrated by the epidemiology, that that measure of risk does not tell us anything about what caused an individual claimant’s ovarian cancer. This point might be correct when the magnitude of the increased risk is small (as is alleged in the talc ovarian cancer litigation), but the sweeping generality of the defense’s assertion is jarring.

Back in the 1960s and 1970s, tobacco companies attempted to rebut inferences of individual causation, despite scientific consensus on general causation, and relative risks of 20 to 30, and more for lung cancer in smoking versus non-smoking groups. The tobacco companies’ claim of the irrelevancy of epidemiology to inferring specific causation was not particularly credible when the population attributable risk was 95 percent and greater.

Even at lower relative risks, measures of risks in epidemiologic studies and clinical trials are used to predict individual responses to treatments, to life style interventions, and to life style and other risk factors. Of course, there is always potential heterogeneity in the sample and in the population, which should be acknowledged, but when the studies are multivariate, with inclusion of the known causes and potential risk factors, then scientists and physicians routinely use these measures of risks and benefits in groups to make predictions about individuals.

Consider a man, seriously overweight, who goes to see his internist. His physician tells him,

“look in populations of overweight men, just like yourself, more men die of heart attack and stroke, and they die of these diseases at an early age, and suffer more morbidity and disability from them, then in groups of men who are not overweight, but don’t worry, that has NOTHING to do with you. We don’t know your risk, so go right on eating candy bars for breakfast, and studiously avoiding exercise.”

Of course, no sane, competent physician would advise the obese patient in this manner. Now, I understand rhetorically why the defense might want to capitalize on Colditz’ statement, but the end result appears to mislead the intended audience. The rejection of probabilistic inferences is still occasionally sanctioned by courts¹¹, but more typically, such inferences are permitted when not conjectural.

Defense’s Misleading Claim that Case-Control Studies are Smaller than Cohort Studies

In its Science Day presentation, the defense asserted that a disadvantage of case-control studies is, among other things, their “small size.” In the same vein, the defense claimed that an advantage of cohort studies is their “large size.” The defense provided no supporting citations for its contention about the relative size of the two kinds of analytical epidemiologic studies.¹²

In his oral comments, the defense presenter notes the size disparity between the case-control and the cohort studies as a reason to distrust the results of the case-control studies on talc exposure and ovarian cancer. The presenter leans in and says that the cohort studies are huge, some with hundreds of thousands of women.

Now there are important qualitative differences between case-control and cohort studies, with respect to recall bias and the validity of control groups. To be sure, and fair, the defense made these points accurately. The defense’s invidious comparison of size of the two types of studies ignores that case-control studies are statistically much more efficient.

As the defense presented the matter, case-control studies are placed lower on the “hierarchy of evidence” than cohort studies. For this point, the defense did present a supporting citation¹³, and their claim is generally correct, but epidemiologists recognize that a well-conducted case-control study may well trump a cohort study. Case-control studies are often ranked below cohort studies because of greater potential for systematic bias, the inherent difficulty in selecting appropriate controls, and because the measure of risk in the form of an odds ratio is at best an estimate of the relative risk. The sizes of the “cases” group in a case-control study and the cohort in a cohort study are not a valid comparison.

A case-control study may be based upon hundreds of cases of ovarian cancer, a size that would require a huge cohort study. Furthermore, the size of the cohort study can be highly misleading because recruitment and inception into the cohort often takes place at a young age, when the rate of ovarian cancer is very low. The efficiency of the case-control study design is reflected in the narrow confidence intervals seen in many of the published papers. Some of these confidence intervals are as narrow as those generated by analysis of data from “larger” cohort studies.¹⁴ The size is ultimately related to the precision of the various studies’ point estimates of measured risk, not to the accuracy of their measurements. The statistical efficiency of the ovarian cancer talc case-control studies becomes an important when rare disease subtypes are considered, or when the interaction between genotype, exposure, and cancer outcomes needs to be considered.

Synthesis of Evidence for Judgments of Causation

Finally, it seems that neither the defense nor the plaintiffs adequately incorporated into their presentations the important concept of causal inference (or how evidence from disparate sources is synthesized into a judgment of causation, or into a rejection of such a claim). Specifically, counsel never explicitly set forth the importance of the Bradford Hill factors, or the techniques of proper and rigorous systematic review methodologies. The defense did touch upon many of the key considerations of the Bradford Hill factors as they applied to the relevant data, but there was no discussion of how these factors are considered after the identification of an association that is not likely the result of bias and that is beyond the play of chance. With respect to meta-analysis, both sides provided no guidance or insight into the problems that arise in conducting, reporting, and interpreting quantitative syntheses of a body of epidemiologic studies.

The Trial Court’s Role

Most trial judges, sadly, come to cases such as the talc ovarian cancer cases without any training in statistics, epidemiology, toxicology, or an adequate understanding of the role that clinical medicine plays (or does not play) in assessing important questions of causation. Judge Nelsen seemed to listen carefully, but asked few questions to suggest that Her Honor understood the discrepancy in statements made in the parties’ presentation.

Perhaps a starting point for Science Day should be an Order that sets out the procedures for the Day, as well as a statement: “The Court has read and studied the relevant chapters in the Reference Manual on Scientific Evidence (3d ed. 2011), and all materials submitted by the parties. The parties should not recreate a tutorial that covers material in the Reference Manual, unless they wish to contest its contents. Specific references to the Manual, in connection with the parties’ presentation would be very helpful to the Court.”

1 In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices & Prods. Liab. Litig., No. 16-2738 (D.N.J.)

2 Johnson & Johnson Talcum Powder Cases, No. JCCP4872 (Calif. Super. Ct., Los Angeles Cty.).

3 “Johnson & Johnson Files Status Report in MDL Docket, Requests ‘Science Day’ to Address Causation in Talc Cases,” HarrisMartin’s Talcum Powder Litigation Report (Nov. 16, 2016).

4 “Parties in Federal Talcum Powder MDL Hold ‘Science Day’,” HarrisMartin’s Talcum Powder Litig. Report (Jan. 26, 2017).

5 Id.

6 Johnson & Johnson Talcum Powder Cases, No. JCCP4872 (Calif. Super. Ct., Los Angeles Cty.).

7 “Plaintiffs Ask Court to Hold ‘Science Day’ in California Coordinated Talcum Powder Docket,” HarrisMartin’s Talcum Powder Litig. Report (Dec. 7, 2016).

8 See “Calif. Court Oversees ‘Science Day’ in Talcum Powder Docket One Day After J&J Opposes Broadcast of Hearing,” HarrisMartin’s Talcum Powder Litig. Report (Mar. 8, 2017).

9 “Defense Slide 129. “Epidemiology Estimates Risk in the Population, Not in Individuals,” quoting from Graham Colditz, “Cancer Culture: Epidemics, Human Behavior, and the Dubious Search for New Risk Factors,” 91 Am. J. Pub. Health 357, 357 (2001).

10 Graham A. Colditz, “From epidemiology to cancer prevention: implications for the 21st Century,” 18 Cancer Causes Control 117, 118 (2007).

11 See, e.g., Smith v. Ortho Pharmaceutical Corp., 770 F. Supp. 1561, 1573 (N.D. Ga. 1991) (“However, in an individual case, epidemiology cannot conclusively prove causation; at best, it can only establish a certain probability that a randomly selected case of disease was one that would not have occurred absent exposure, or the ‘relative risk’ of the exposed population. Epidemiology, therefore, involves evidence on causation derived from group-based information, rather than specific conclusions regarding causation in an individual case.”).

12 See Defense Slide 134, “Disadvantages of Case-Control Studies,” which sets out in bullet points, “Recall Bias, Confounding, Small Size.” And in Defense Slide 135, “Epidemiologic Studies on Talc and Ovarian Cancer: Three Types Large Prospective Cohort Studies,” the defense touts advantages of cohort studies to include “No Recall Bias” and “Large Size.” The slides contained no supporting citation for the contention about size.

13 See Defense Slide 136, “Epidemiology Studies on Talc and Ovarian Cancer: Three Types,” where the defense places case-control studies lower on the “hierarchy of evidence” than cohort studies, citing Trisha Greenhalgh, “How to Read a Paper,” 315 Brit. Med. J. 241 (1997).

14 See Wera Berge, Kenneth Mundt, Hung Luu & Paolo Boffetta, “Genital use of talc and risk of ovarian cancer: a meta-analysis,” European J. Cancer Prevention (2017), in press, DOI: 10.1097/CEJ.0000000000000340.

APPENDIX

American Bar Association’s “Civil Trial Practice Standards” (August 2007).

7. Use of Tutorials to Assist the Court

a. Pretrial Use of Tutorials. In cases involving complex technology or other complex subject matter which may be especially difficult for non-specialists to comprehend, the court may permit or require the use of tutorials to educate the court. Tutorials are intended to provide the court with background information to assist the court in understanding the technology or other complex subject matter involved in the case. Tutorials may, but need not, seek to explain the contentions or arguments made by each party with respect to the technology or complex subject matter.

b. Selection of Type of Tutorial.

i. In any case in which the court believes one or more tutorials might be useful in assisting it in understanding the complex technology or other complex subject matter, the court should invite the parties to express their views on the desirability of one or more tutorials.

ii. Once the court decides to permit or require one or more tutorials, it should invite the parties to suggest the subject matter and format of each tutorial.

iii. If the parties cannot agree on the subject matter and format, the court should invite each party to submit a description of any tutorial it proposes and to explain how that tutorial will assist the court and why it is preferable to the tutorial proposed by another party. The court may approve one or more tutorials proposed by the parties, or the court may fashion its own tutorial after providing the parties with an opportunity to comment on the court’s proposed subject matter and format.

c. Procedures for Presentation. A court may consider the following procedures for the presentation of tutorials:

i. An in-court or recorded presentation by an expert jointly selected by the parties.

ii. An in-court or recorded presentation by one or more experts on behalf of each party.

iii. An in-court or recorded presentation by counsel for each party.

iv. A combined in-court or recorded presentation by counsel and one or more experts on behalf of each party.

v. An in-court or recorded presentation by an expert appointed by the court, which may include cross-examination by counsel for each party.

vi. Recorded presentations that have been prepared for generic use in particular kinds of cases by reliable sources such as the Federal Judicial Center.

d. Trial Use of Tutorials. In cases involving complex technology or other complex subject matter which may be especially difficult for non-specialists to comprehend, the court may permit or require the use of tutorials to educate the court or jury during one or more stages of the trial. Trial tutorials are intended to provide the court or jury with background information to assist in understanding the technology or other complex subject matter involved in the case. Tutorials may, but need not, seek to explain the contentions or arguments made by each party with respect to the technology or complex subject matter.

e. Selection of Type of Tutorial. The court should use the process set forth in 7.b. above.

f. Procedures for Presentation.

i. In a bench trial, the court may consider using any of the procedures set forth in 7.b. above.

ii. In a jury trial, the court should consider the use of tutorials in connection with interim statements and arguments as provided in

Standard 9.

iii. In both bench and jury trials, the court should provide parties with a full opportunity to present admissible evidence in support of their cases that may differ from or quarrel with information presented in a tutorial and to argue that the information presented in a tutorial should be rejected by the court or jury.

Posted in Rule 702, Scientific Evidence | Comments Off on Science Day Should Be Every Day in Our Courtrooms — Part II

Science Day Should Be Every Day in Our Courtrooms — Part I

March 24th, 2017

The following post and its sequel are an expansion upon a post that I wrote with Dr. David Schwartz, of Innovative Science Solutions, LLC. Dr. Schwartz is a talented scientist with whom I had the privilege and pleasure to work at McCarter & English, before he left to become an independent scientific consultant. Dr. Schwartz is one of the founding partners of his firm, which focuses on helping lawyers with the scientific issues in complex health effects litigation. Our earlier post can be found on the Courtroom View Network’s website. “Guest Analysis: Key Takeaways from Recent Talc Powder ‘Science Day’ Hearing in California,” Courtroom View Network (Mar 24, 2017).

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Every February 28^th, India celebrates National Science Day in honor the Indian physicist Sir Chandrashekhara Venkata Raman, who discovered the Raman effect. The United States has no equivalent celebration, but “Science Days” have become a commonplace in complex state and federal Litigations, around the country.

Background

The major impetus for science tutorials seems to have come from the United States Supreme Court’s decision in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The holding of Daubert, now incorporated into, and extended by Federal Rule of Evidence 702, requires trial judges to act as gatekeepers of the relevance and reliability of expert witness opinion testimony in their courtrooms. One of the first tests of the judiciary’s performance to perform this role came in the silicone gel breast implant litigation. The federal silicone cases were consolidated before Judge Pointer Sam C. Pointer, Jr., in MDL 926. Judge Pointer believed that trial judges in the transferor courts should conduct whatever review of expert witness opinion was needed to satisfy the then recent Daubert decision.

Some of the first federal silicone lawsuits remanded from the MDL went to Judge Robert Jones in Portland Oregon. These cases involved complex issues of immunology, clinical rheumatology, epidemiology, toxicology, surgery, and polymer and analytical chemistry. At the outset of his case management of the remanded cases, plaintiffs’ counsel requested that Judge Jones schedule an all-day tutorial for counsel to present on these scientific issues. The parties’ tutorials, along with an avalanche of defense Daubert motions, persuaded Judge Jones to take the unusual step of appointing technical advisors to assist him in assessing the scientific evidence, inferences and claims in the silicone litigation. See Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1415 (D. Ore. 1996).¹ Judge Jones’s technical advisors attended court throughout the Daubert hearings conducted in Portland, and they delivered advisory reports to Judge Jones to assist him in his gatekeeping function. Judge Jones ultimately granted the defense motions to exclude the plaintiffs’ expert witnesses’ claims of silicone causation of connective tissue diseases.

In large measure because of Judge Jones’s case management and exclusion of expert witness testimony, the silicone MDL court appointed a panel of neutral expert witnesses, in the fields of epidemiology, rheumatology, immunology, and toxicology.²

One of the first requests received from the Science Panel in MDL 926 was for what turned out to be a series of Science Days in which the parties’ expert witnesses would present to them, and explain their interpretation of the vast array of evidence, from different disciplines. Each presenting party expert witness was allowed 15 to 20 minutes to present. The lawyers were not entirely reduced to potted plants; they had a chance to conduct a short cross-examination. Given that the primary audience was a panel of four distinguished scientists, there was an emphasis for most of the lawyers, for the plaintiffs and the defendants, to ask pertinent, substantive questions.

The Science Panel was not entirely satisfied with the party expert witnesses, and requested a second Science Day, at which the Panel could call its own slate of scientists to address the scientific claims made in the litigation. The proceedings took place at the National Academies of Science, in Washington, D.C.

These proceedings, along with extensive submissions of articles and briefings from the parties led to the Report of National Science Panel, on November 30, 1998.

Every Day is Science Day, Somewhere

Since the breast implant litigation, many MDL and other courts have faced complex causation claims in litigation involving pharmaceutical products, medical devices, consumer products and a host of chemical exposures. Appointment of independent, neutral expert witnesses remains unusual, but trial judges have welcomed tutorials in the form of “Science Days,” to help them learn the methodologies and vocabularies of the scientific disciplines that are involved in the litigations before them. For some reason, the parties, the judges, and the legal media often reference Science Days in scare quotes, signaling that perhaps other Science takes place in these proceedings. Whether the scare quotes are warranted remains to be determined.

“Science Days” have become a tradition in mass tort litigation.³ In the last few years, there is a Science Day somewhere, in some courtroom, going on, perhaps not daily, but with sufficient frequency that the phenomenon should receive more critical attention. Federal judges with multi-district litigation, or state judges with multi-county cases, set aside time to permit the parties a chance to educate them about the scientific and technical aspects of the litigations before them. Judges know that Daubert and Rule 702, or their state analogues, require them to act as gatekeepers. Furthermore, myriad motions in the discovery and trial phases of a case will require judges to make nuanced but accurate decisions about scope and content of discovery, and admissibility of documents and testimony,

Science Day – Have It Your Way

John Milton: We negotiating?

Kevin Lomax: Always.⁴

The Devil’s Advocate (1997).

There are no federal or state rules that set out procedures for science tutorials for judges or their appointed expert. The form and substance of Science Days depend upon a three-say negotiation among the plaintiffs, defendants, and the trial judge. Although the parties are often left to work out a plan for science day, most courts tend to weigh in by imposing time limits, and they may even rule in or rule out live witness testimony.

In 2007, the American Bar Association set out Civil Trial Practice Standards,⁵ which included an entire section on the use of tutorials to assist the court. [The relevant standards for tutorials is set out at the end of Part II of this post, as an appendix.]

1 See Laural L. Hooper, Joe S. Cecil, and Thomas E. Willging, “Neutral Science Panels: Two Examples of Panels of Court-Appointed Experts in the Breast Implants Product Liability Litigation,” at 9 (Federal Judicial Center 2001).

2 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).

3 See, e.g., Barbara J. Rothstein & Catherine R. Borden, Managing Multidistrict Litigation in Products Liability Cases: A Pocket Guide for Transferee Judges at 39 & n. 54 (Fed. Jud. Ctr. 2011); Sean Wajert, “‘Science Day’ In Mass Torts,” Mass Tort Defense (Oct. 20, 2008); Lisa M. Martin, “Using Science Day to Your Advantage,” 2(4) Pro Te: Solutio 9 (2009).

4 From the screenplay of the movie, directed by Taylor Hackford, written by Jonathan Lemkin and Tony Gilroy, and based on a novel by Andrew Neiderman.

5 American Bar Association’s “Civil Trial Practice Standards” (August 2007 & 2011 Update).

Posted in Rule 702, Scientific Evidence, Trial Procedure | Comments Off on Science Day Should Be Every Day in Our Courtrooms — Part I

Washington Legal Foundation’s Paper on Statistical Significance in Rule 702 Proceedings

March 13th, 2017

The Washington Legal Foundation has released a Working Paper, No. 201, by Kirby Griffis, entitled “The Role of Statistical Significance in Daubert / Rule 702 Hearings,” in its Critical Legal Issues Working Paper Series, (Mar. 2017) [cited below as Griffis]. I am a fan of many of the Foundation’s Working Papers (having written one some years ago), but this one gives me pause.

Griffis’s paper manages to avoid many of the common errors of lawyers writing about this topic, but adds little to the statistics chapter in the Reference Manual on Scientific Evidence (3d ed. 2011), and he propagates some new, unfortunate misunderstandings. On the positive side, Griffis studiously avoids the transposition fallacy in defining significance probability, and he notes that multiplicity from subgroups and multiple comparisons often undermines claims of statistical significance. Griffis gets both points right. These are woefully common errors, and they deserve the emphasis Griffis gives to them in this working paper.

On the negative side, however, Griffis falls into error on several points. Griffis helpfully narrates the Supreme Court’s evolution in Daubert and then in Joiner, but he fails to address the serious mischief and devolution introduced by the Court’s opinion in Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 131 S.Ct. 1309 (2011). See Schachtman, “The Matrixx – A Comedy of Errors” (April 6, 2011)”; David Kaye, “Trapped in the Matrixx: The U.S. Supreme Court and the Need for Statistical Significance,” BNA Product Safety & Liability Reporter 1007 (Sept. 12, 2011). With respect to statistical practice, this Working Paper is at times wide of the mark.

Non-Significance

Although avoiding the transposition fallacy, Griffis falls into another mistake in interpreting tests of significance; he states that a non-significant result tells us that an hypothesis is “perfectly consistent with mere chance”! Griffis at 9. This is, of course, wrong, or at least seriously misleading. A failure to reject the null hypothesis does not prove the null such that we can say that the “null results” in one study were perfectly consistent with chance. The test may have lacked power to detect an “effect size” of interest. Furthermore, tests of significance cannot rule out systematic bias or confounding, and that limitation alone ensures that Griffis’s interpretation is mistaken. A null result may have resulted from bias or confounding that obscured a measurable association.

Griffis states that p-values are expressed as percentages “usually 95% or 99%, corresponding to 0.05 or 0.01,” but this states things backwards. The p-value that is pre-specified to be “significant” is a probability or percentage that is low; it is the coefficient of confidence used to construct a confidence interval that is the complement of the significance probability. Griffis at 10. An alpha, or pre-specified statistical significance level, of 5% thus corresponds to a coefficient of confidence of 95% (or 1.0 – 0.05).

The Mid-p Controversy

In discussing the emerging case law, Griffis rightly points to cases that chastise Dr. Nicholas Jewell for the many liberties he has taken in various litigations as an expert witness for the lawsuit industry. One instance cited by Griffis is the Lipitor diabetes litigation, where the MDL court suggested that Jewell switched improperly from a Fisher’s exact test to a mid-test. Griffis at 18-19. Griffis seems to agree, but as I have explained elsewhere, Fisher’s exact test generates a one-tailed measure of significance probability, and the analyst is left to one of several ways of calculating a two-tailed test. See “Lipitor Diabetes MDL’s Inexact Analysis of Fisher’s Exact Test” (April 21, 2016). The mid-p is one legitimate approach for asymmetric distributions, and is more favorable to the defense than passing off the one-tailed measure as the result of the test. The mere fact that a statistical software package does not automatically specify the mid-p for a Fisher’s exact analysis does not make invoking this measure into p-hacking or other misconduct. Doubling the attained significance probability of a particular Fisher’s exact test result is generally considered less accurate than a mid-p calculation, even though some software packages using doubling attained significance probability as a default. As much as we might dislike bailing Jewell out of Daubert limbo, on this one, limited point, he deserved a better hearing.

Mis-Definitions

On recounting the Bendectin litigation, Griffis refers to the epidemiologic studies of birth defects and Bendectin as “experiments,” Griffis at 7, and then describes such studies as comparing “populations,” when he clearly meant “samples.” Griffis at 8.

Griffis conflates personal bias with bias as a scientific concept of systematic error in research, a confusion usually perpetuated by plaintiffs’ counsel. See Griffis at 9 (“Coins are not the only things that can be biased: scientists can be, too, as can their experimental subjects, their hypotheses, and their manipulations of the data.”) Of course, the term has multiple connotations, but too often an accusation of personal bias, such as conflict of interest, is used to avoid engaging with the merits of a study.

Relative Risks

Griffis correctly describes the measure known as “relative risk” as a determination of the “the strength of a particular association.” Griffis at 10. The discussion then lapses into using a given relative risk as a measure of the likelihood that an individual with the exposure studied develop the disease. Sometimes this general-to-specific inference is warranted, but without further analysis, it is impossible to tell whether Griffis lapsed from general to specific, deliberately or inadvertently, in describing the interpretation of relative risk.

Conclusion

Griffis is right in his chief contention that the proper planning, conduct and interpretation statistical tests is hugely important to judicial gatekeeping of some expert witness opinion testimony under Federal Rule of Evidence 702 (and under Rule 703, too). Judicial and lawyer aptitude in this area is low, and needs to be bolstered.

Posted in Rule 702, statistical evidence | Comments Off on Washington Legal Foundation’s Paper on Statistical Significance in Rule 702 Proceedings

New York Rejects the Asbestos Substantial Factor Ruse (Juni Case)

March 2nd, 2017

I recall encountering Dr. Joseph Sokolowski in one of my first asbestos personal injury cases, 32 years ago. Dr. Sokolowki was a pulmonary specialist in Cherry Hill, New Jersey, and he showed up for plaintiffs in cases in south Jersey as well as in Philadelphia. Plaintiffs’ counsel sought him out for his calm and unflappable demeanor, stentorious voice, and propensity for over-interpreting chest radiographs. (Dr. Sokolowski failed the NIOSH B-Reader examination.)

At the end of his direct examination, the plaintiff’s lawyer asked Dr. Sokolowski the derigueur “substantial factor” question, which in 1985 had already become a customary feature of such testimonies. And Dr. Sokolowski delivered his well-rehearsed answer: “Each and every exposure to asbestos was a substantial factor in causing the plaintiff’s disease.”

My cross-examination picked at the cliché. Some asbestos inhaled was then exhaled. Yes. Some asbestos inhaled was brought up and swallowed. Yes. Asbestos that was inhaled and retained near the hilum did not participate in causing disease at the periphery of the lung. Yes. And so on, and so forth. I finished with my rhetorical question, always a dangerous move, “So you have no way to say that each and every exposure to asbestos actually participated in causing the plaintiff’s disease?” Dr. Sokolowski was imperceptibly thrown off his game, but he confessed error by claiming the necessity to cover up the gap in the evidence. “Well, we have no way to distinguish among the exposures so we have to say all were involved.”

Huh? What did he say? Move to strike the witness’s testimony as irrational, and incoherent. How can a litigant affirmatively support a claim by asserting his ignorance of the necessary foundational facts? The trial judge overruled my motion with alacrity, and the parties continued with the passion play called asbestos litigation. The judge was perhaps simply eager to get on with his docket of thousands of asbestos cases, but at least Dr. Sokolowski and I recognized that the “substantial factor” testimony was empty rhetoric, with no scientific or medical basis.

Sadly, the “substantial factor” falsehood was already well ensconced in 1985, in Pennsylvania law, as well as the law of most other states. Now, 32 years later, with ever increasingly more peripheral defendants, each involving less significant, if any, asbestos exposure, the “substantial factor” ruse is beginning to unravel.¹

Juni v. A.O. Smith Water Products Co.

Arthur Juni was a truck and car car mechanic, who worked on the clutches, brakes, and manifold gaskets of Ford trucks. Juni claimed to have sustained asbestos exposure in this work, as well as in other aspects of his work career. In 2012, Juni was diagnosed with mesothelioma; he died in 2014. Juni v. A.O. Smith Water Products Co., at *1,No. 190315/12 2458 2457, 2017 N.Y. Slip Op. 01523 (N.Y. App. Div. 1st Dep’t, Feb. 28, 2017).

Juni sued multiple defendants in New York Supreme Court, for New York County. Most of the defendants settled, but Ford Corporation tried the case against the plaintiff’s widow. Both sides called multiple expert witnesses, whose testimony disputed whether the chrysotile asbestos in Ford’s brakes and clutches could cause mesothelioma. The jury returned a verdict in favor of the plaintiff, but the trial court granted judgment nothwithstanding the verdict, on the ground that the evidence failed to support the causation verdict. Id. At *1; see Juni v. A. 0. Smith Water Prod., 48 Misc. 3d 460, 11 N.Y.S.3d 415 (N.Y. Sup. Ct. 2015).

Earlier this week, the first department of the New York Appellate Division affirmed the judgment for Ford. 2017 N.Y. Slip Op. 01523. The Appellate Division refused to approve plaintiffs’ theory of cumulative exposure to show causation. The plaintiffs’ expert witnesses, Drs. Jacqueline Moline and Stephen Markowitz, both asserted that even a single asbestos exposure was a “substantial contributing” cause. The New York appellate court, like the trial court before, saw through the ruse, and declared that both expert witnesses had failed to support their assertions.

The “Asbestos Exception” Rejected

Although New York has never enacted a codified set of evidence rules, and has never expressly adopted the rule of Daubert v. Merrill Richardson, the New York Court of Appeals has held that there are limits to the admissibility of expert witness opinion testimony. Parker v. Mobil Oil Corp., 7 N.Y.3d 434 (2006), and Cornell v. 360 W. 51st St. Realty, LLC, 22 NY3d 762 (2014); Sean Reeps. v BMW of North Am., LLC, 26 N.Y.3d 801 (2016). In Juni, the Appellate Division, First Department, firmly rejected any suggestion that plaintiffs’ expert witnesses in asbestos cases are privileged against challenge over admissibility or sufficiency because the challenges occur in an asbestos case. The plaintiff’s special pleading that asbestos causation of mesothelioma is too difficult was invalidated by the success of other plaintiffs, in other cases, in showing that a specific occupational exposure was sufficient to cause mesothelioma.

The Appellate Division also rejected the plaintiff’s claim, echoed in the dissenting opinion of one lone judge, that there exists a “consensus from the medical and scientific communities that even low doses of asbestos exposure, above that in the ambient environment, are sufficient to cause mesothelioma.” The Court held that this supposed consensus is not material to the claims of a particular plaintiff against a particular defendant, especially when the particular exposure circumstance is not associated with mesothelioma in most of the relevant studies. In Juni, the defense had presented many studies that failed to show any association between occupational brake work and mesothelioma. The court might also have added that a characterization of low exposure is extremely amiguous, depending upon the implicit comparison that is being made with other exposures. It is impossible to fit a particular plaintiff’s exposure into the scale of low, medium, and high without some further context.

Single Exposure Sufficiency Rejected

The evidence that chrysotile itself causes mesothelioma remains weak, but the outcome of Juni turned not on the broad general causation question, but on the question whether even suggestive evidence of chrysotile causation had been established for the exposure circumstances of an automobile mechanic, such as Mr. Juni. Plaintiffs’ expert witnesses maintained that Juni’s cumulative asbestos exposures caused his mesothelioma, but they had no meaningful quantification or even reasonable estimate of his exposure.

Citing the Court of Appeals decision in Reeps, the Appellate Division held that plaintiff’s expert witnesses’ causation opinions must be supported by reasonable quantification of the plaintiff’s exposure, or some some scientific method, such as mathematical modeling based upon actual work history, or by comparison of plaintiff’s claimed exposure with the exposure of workers in reported studies that establish a relevant risk from those workers’ exposure. In the Juni case, however, there were no exposure measurements or scientific models, and the comparison with workers doing similar tasks failed to show a causal relationship between the asbestos exposure in those tasks and mesothelioma.

Expert Witness Admissibility and Sufficiency Requires Evaluation of Both Direct and Cross-examination Testimony and Relied Upon Studies

The Juni decision teaches another important lesson for challenging expert witness testimony in New York: glib generalizations delivered on direct examination must be considered in the light of admissions and concessions made on cross-examination, and the entire record. In Juni, the plaintiffs’ expert witnesses, Jacqueline Moline and Stephen Markowitz, asserted that asbestos in Ford’s friction products was a cause of plaintiff’s mesothelioma. Cross-examination, however, revealed that these assertions were lacking in factual support.

Cumulative Exposure

On cross-examination, the plaintiffs’ expert witnesses’ statements about exposure levels proved meaningless. Moline attempted to equate visible dust with sufficient asbestos exposure to cause disease, but she conceded on cross-examination that studies had shown that 99% of brake lining debris was not asbestos. Most of the dust observed from brake drums is composed of resins used to manufacture brake linings and pads. The heat and pressure of the brake drum causes much of the remaining chrysotile to transform into a non-fibrous mineral, fosterite.

Similarly, Markowitz had to acknowledge that chrysotile has a “serpentine” structure, with individual fibers curling in a way that makes deeper penetration into the lungs more difficult. Furthermore, chrysotile, a hydrated magnesium silicate, melts in the lungs, not in the hands. The human lung can clear particulates, and so there is no certainty that remaining chrysotile fibers from brake lining exposures ever reach the periphery of the lung, where they could interact with the pleura, the tissue in which mesothelioma arises.

Increased Risk, “Linking,” and Association Are Not Causation – Exculpatory Epidemiologic Studies

When pressed, plaintiffs’ expert witnesses lapsed into characterizing the epidemiologic studies of brake and automobile mechanics as showing increased risk or association, not causation. Causation, not association, however, was the issue. Witnesses’ invocation of weasel words, such as “increased risk,” “linkage,” and “association” are insufficient in themselves to show the requisite causation in long-latency toxic exposure cases. For automobile mechanics, even the claimed association was weak at best, with plaintiffs’ expert witnesses having to acknowledge that 21 of 22 epidemiologic studies failed to show an association between automobile mechanics’ asbestos exposure and risk of mesothelioma.

The Juni case was readily distinguishable from other cases in which the Markowitz was able to identify epidemiologic studies that showed that visible dust from a specific product contained sufficient respirable asbestos to cause mesothelioma. Id. (citing Caruolo v John Crane, Inc., 226 F.3d 46 (2d Cir. 2000). As the Appellate Division put the matter, there was no “no valid line of reasoning or permissible inference which could have led the jury to reach its result.” Asbestos plaintiffs must satisfy the standards set out in the New York Court of Appeals decisions, Parker v. Mobil Oil Corp., 7 NY3d 434 2006), and Cornell v. 360 W. 51st St. Realty, LLC, 22 N.Y.3d 762 (2014), for exposure evidence and causal inferences, as well.

New York now joins other discerning courts in rejecting regulatory rationales of “no safe exposure,” and default “linear no threshold” exposure-response models as substitutes for inferring specific causation.² A foolish consistency may be the hobgoblin of little minds, but in jurisprudence, consistency is often the bedrock for the rule of law.

1 The ruse of passing off “no known safe exposure” as evidence that even the lowest exposure was unsafe has been going on for a long time, but not all judges are snookered by this rhetorical sleight of hand. See, e.g., Bostic v. Georgia-Pacific Corp., 439 S.W.3d 332, 358 (Tex. 2014) (“the failure of science to isolate a safe level of exposure does not prove specific causation”).

2 See, e.g. Bostic v. Georgia-Pacific Corp., 439 S.W.3d 332, 358 (Tex. 2014) (failing to identify safe levels of exposure does not suffice to show specific causation); Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1165-66 (E.D. Wash. 2009) (rejecting a “no threshold” model of exposure-response as unfalsifiable and unvalidated, and immaterial to the causation claims); Pluck v. BP Oil Pipeline Co., 640 F.3d 671, 679 (6th Cir. 2011) (rejecting claim that plaintiff’s exposure to benzene “above background level,” but below EPA’s maximum permissible contaminant level, caused her cancer); Newkirk v. ConAgra Foods, Inc., 727 F. Supp. 2d 10006, 1015 (E.D. Wash. 2010) (rejecting Dr. David Egilman’s proffered testimony on specific causation based upon his assertion that there was no known safe level of diacetyl exposure).

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