TORTINI

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

Lawsuit Magic – Turning Talcum into Wampum

August 27th, 2017

Last week, a Los Angeles jury, with little prior experience in giving away other people’s money, awarded Eva Echeverria $417,000,000 dollars, in compensatory and punitive damages.1 Pundits in the media, and from both sides of the bar, including your humble blogger, jumped in to offer their speculation about the cause of profligacy.2

In speaking to one reporter, I described the evidence against Johnson & Johnson in an earlier trial (Slemp) as showing that the company needed to engage more fully with the scientific evidence, and not reduce complex evidence to sound bites. Alas, no good deed goes unpunished; my comments were reduced to sound bites! The reporter quoted me in part as having said that the case was a tough one for the defense, but left out that I thought the case was tough because the defense will have a difficult time educating judges and juries in the scientific methods and judgment needed to reach a sound conclusion. The reporter suggested that I had opined that the evidence against J & J was “compelling,” when I had suggested the evidence was confounded and biased, and that J & J needed to take greater care in addressing study validity.3

Perhaps more interesting than my speculation is the guesswork of the plaintiffs’ counsel, who has had more experience with conjecture than I will ever enjoy. In an interview with an American Law Media reporter4, Allen Smith offered his view that three “new” pieces of evidence explain the Los Angeles hyper-verdict:

1. evidence that other companies selling consumer talcum power have begun to place ovarian cancer warnings on their packaging, within the few months;

2. evidence that two persons involved in the Cosmetic Industry Review, which has concluded that talcum powder is safe, had received payments from Johnson & Johnson for speaking engagements; and

3. evidence that Douglas Weed, a former National Cancer Institute epidemiologist, who testified for Johnson & Johnson as an expert witness in the Echeverria case, had been sanctioned in another, non-talc case in North Carolina, for lying under oath about whether he had notes to his expert report in that other case.

Smith claimed that the new evidence was “very compelling,” especially the evidence that Johnson & Johnson had presented “unbelievable and non-credible witnesses on an issue so important like this.”

Now, Smith was trial counsel. He was intimately involved in presenting the evidence, and in watching the jurors’ reactions. Nonetheless, I am skeptical that these three “bits” explain the jury’s extravagance.

The first “bit” seems completely irrelevant. The fact of another company’s having warned within months of the trial, and years after the plaintiff was diagnosed with ovarian cancer, suggests that the evidence was inflammatory without having any probative value. Feasibility of warning was not an issue. State of the art was an issue. In the Slemp trial, Graham Colditz testified that he had had his epiphany that talc causes ovarian cancer only two years ago, when he was instructed by plaintiffs’ counsel to formulate an opinion on the causal claim. That another company recently placed a warning to ward off the lawsuit industry is hardly evidence of industry or governmental standard. All that can really be said is that some companies have been bullied or scared into warnings by the Lawsuit Industry, in the hopes of avoiding litigation. Indeed, it is not at all clear how this bit of irrelevancy was admitted into evidence. All in all, this evidence of a recent warning, years after the plaintiff’s use of the defendant’s talcum powder seems quite out of bounds.

The second bit was simply more of the same inflammatory, scurrilous attacks on Johnson & Johnson. Having watched much of the Slemp trial, I can say that this was Allen Smith’s stock in trade. From media reports, he seemed to have succeeded in injecting his personal attacks on the most peripheral of issues into the Echeverria trial. Not everything in Slemp was collateral attack, but a lot was, and much of it was embarrassing to the legal system for having tolerated it.

The third bit of evidence about Dr. Weed’s having been sanctioned was news to me. A search on Westlaw and Google Scholar failed to find the sanctions order referred to by plaintiffs’ counsel. If anyone is familiar with the North Carolina case that gave rise to the alleged court sanction, please send me a copy or a citation.


1 Daniel Siegal, “J&J Hit With $417M Verdict In 1st Calif. Talc Cancer Trial,” Law360 (Aug. 21, 2017). The case was Echeverria v. Johnson & Johnson, case no. BC628228, Los Angeles Cty. Superior Court, California.

2 See Daniel Siegal, “Science No Salve For J&J In Talc Cases, $417M Verdict Shows,” Law360, Los Angeles (Aug. 22, 2017). See also Margaret Cronin Fisk & and Edvard Pettersson, “J&J Loses $417 Million Talc Verdict in First California Case,” Bloomberg News (Aug. 21, 2017).

3 Tina Bellon, “Massive California verdict expands J&J’s talc battlefield,” Reuters (Aug. 22, 2017); Tina Bellon, “Massive California verdict expands J&J’s talc battlefield,” CNBC (Aug. 22, 2017); Tina Bellon, “J&J’s talc woes expand with massive California verdict,” BNN Reuters (Aug. 22, 2017).

4 Amanda Bronstad, “New Evidence Seen as Key in LA Jury’s $417M Talc Verdict,” Law.com (Aug. 22, 2017).

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).

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. SeeDemonstration 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:

  1. 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
  1. when it is relevant under the doctrine of law of the case, res judicata, or collateral estoppel, and
  1. 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).

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. SeeNon-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).

The Slemp Case, Part I – Jury Verdict for Plaintiff – 10 Initial Observations

May 13th, 2017

While I greatly appreciate you informing me, on three separate occasions, that I am not under investigation, I nevertheless concur with the judgment of the Department of Justice that you are not able to effectively lead the Bureau.”

Letter from Donald Trump to James Comey (May 9, 2017) (emphasis added)

Just as a President’s poor diction does not define or guide good English grammar, a lay civil jury’s verdict on scientific issues does not resolve open scientific questions of causation between exogenous exposures and cancer or other chronic disease outcomes. Last week, a jury in St. Louis returned a substantial verdict for compensatory and punitive damages against Johnson & Johnson, and others, for supposedly causing Lois Slemp to develop ovarian cancer. From some of the media coverage, readers might infer that Ms. Slemp’s attorneys’ had presented a credible case of causation between perineal talc use and ovarian cancer. See, e.g., Daniel Siegal, “J&J Hit With $110M Verdict In Latest Mo. Talc Cancer Trial,” Law360 (May 4, 2017). The cause of this verdict requires close scrutiny of the scientific evidence, the jury and juries generally, the lawyering from both sides, and the judicial management of the trial. 

Hit.” Hit? When did comic-book language invade legal journalism? Why not “slammed,” “zapped,” or “kapow”?

The case, which has gained this recent notoriety is Lois Slemp v. Johnson & Johnson, case no. 1422-CC09326-01, 22nd Judicial Circuit Court of Missouri. The jury awarded Ms. Slemp $5.4 million in compensation, and $66 million against Johnson & Johnson, $39 million against Johnson & Johnson Consumer, and $50,000 against Imerys (the talc miner and supplier), in punitive damages. On the compensatory award, the jury ascribed 99 percent of fault to the two J & J companies, and 1 percent to Imerys. Id.

The truth is that the Slemp verdict, as is the case for most civil jury verdicts, does not represent a valid scientific judgment. Nonetheless, the verdict requires explanation. If talc does not cause ovarian cancer, we may well ask whether the case was poorly defended, whether the court system failed to serve as a gatekeeper, and whether the scientific case was beyond the comprehension of the lay jury.

The verdict of course also raises serious questions about our civil justice system. The law of products liability typically states that a manufacturer or seller is held to the level of an expert in knowing the harmful aspects of its products. If this knowledge is widely known about consumers, then the seller will generally have an obligation to warn about the latent harm. But what happens when there is no knowledge of a causal relationship? Or what happens when experts legitimately disagree? How can a manufacturer or seller be charged with outrageous misconduct, let alone negligence, when experts sincerely and legitimately disavow a causal relationship?

David H. Schwartz, Ph.D. of Innovative Science Solutions LLC, and I posted a preliminary, big-picture overview of the Slemp case at the Courtroom View Network’s website. See Schwartz & Schachtman, “10 Key Scientific Takeaways From Recent $110M Talc Powder Verdict,” Courtroom View Network Blog (May 12, 2017). Thanks to the generosity of Courtroom View, David and I were able to view the video of the Slemp trial, and to evaluate the legal process of presenting a complicated scientific case to a lay jury. There is much to be said about that process, what went right and what went wrong, but for now, I will simply repeat, below, what we said on CVN’s blog. I hope in subsequent posts to look more closely at specific issues, especially with respect to the presentation of statistical and epidemiologic evidence, by all parties.

* * * * *

The following is a republication (with minor formatting changes) of the original post, by David H. Schwartz and Nathan Schachtman. 

Establishing a rigorous and reliable causal inference between an exposure and an adverse health outcome is one of the most difficult things to do in the health sciences. However, it is sometimes even more difficult to effectively and appropriately demonstrate that a causal relationship does not exist.

The difficulty of this task was illustrated in the most recent talcum powder trial in St. Louis, Missouri. As was widely reported, Johnson & Johnson and talc raw material producer Imerys received the third (and largest) plaintiff verdict in their four recent talc trials (3 plaintiff verdicts and one defense verdict). Having the enviable opportunity to watch the trial (in real time or on demand) on Courtroom View Network’s website provides an invaluable opportunity to review and learn from an important ongoing mass tort action.

At this trial, the defense put up a single expert witness, Dr. Huh, a clinician who defended the aggressive and wide-ranging scientific claims advanced by plaintiff’s expert witnesses in a number of scientific disciplines, including epidemiology, clinical medicine, and pathology. Dr. Huh, a skilled and experienced ObGyn and a clinical gynecological oncologist, attempted to neutralize plaintiff’s scientific allegations made by putting the clinical characteristics of the patient into context, while dismissing the many statistically significant epidemiological studies touted by plaintiffs as adequately establishing a causal inference for talcum powder and ovarian cancer.

In his cross examination, plaintiff counsel continuously barraged Dr. Huh with technical observations relating to the large body of epidemiologic studies that plaintiff expert witnesses claimed demonstrated that talc exposure caused ovarian cancer. From the perspective of a scientist who has consulted with many product manufacturers alleged to cause cancer and other chronic diseases, and a lawyer who has tried many science-based cases over the past 32 years, this most recent trial illustrates some important and emblematic issues that arise in pharmaceutical, medical device, and toxic tort cases. We provide 10 such observations below.

1. Provide overall context of Bradford Hill criteria

Unlike other legal cases where there is a paucity of epidemiologic data showing statistically significant associations between an exposure and a disease endpoint, in this case there are many epidemiologic studies – and even some meta-analyses – that invite plaintiffs to make the claim that the available scientific evidence meets the Bradford Hill criteria. Therefore, it is critical to provide the jury with a lucid understanding of why the Bradford Hill criteria are utilized and how they should appropriately be applied. Indeed, the Bradford Hill criteria were developed for a situation exactly like the talc litigation; that is, a relatively weak association is reported and scientists want to determine whether that association should validly and reliably be considered causal.

2. Build solid foundation for “correlation does not equal causation” argument

Multiple studies assert an association between talc and ovarian cancer. However, the defense position is that the studies used to make this assertion suffer from bias and confounding, making them unreliable. Relying upon multiple flawed or biased studies to demonstrate a relationship between two factors does not make the two factors causally related. For example, it does not matter how many times one shows that wearing work boots is associated with back injury, it does not make wearing work boots a cause of back injury. (The two factors are associated, but not causally so.) It is critical for the defense to make it crystal clear (as many times as he is questioned) that “correlation does not equal causation.”

3. Develop a genetic defense

Knowledge of the role of genetic data related to ovarian cancer is moving at breakneck speed. Indeed, a study was published in March identifying nine new susceptibility loci for different epithelial ovarian cancer histotypes. While these data may or may not have been relevant to the individual patient in the Slemp trial, there is no way to know unless the defense had a full genome sequence of the plaintiff’s germline. Such information could conceivably be aligned with newly published data to demonstrate that her genetic profile was consistent with the development of ovarian cancer.

4. Hone the lack of consistency argument

Not surprisingly, in his cross examination of Dr. Huh, plaintiff counsel repeatedly referred to the many case-control studies that reported statistically significant associations between talc and ovarian cancer to support the view that the Hill criterion of “consistency” was met. Dr. Huh repeatedly attempted to rebut this assertion, but failed to make a clear argument as to why these multiple studies failed to support the criterion of consistency. He did refer to the fact that the cohort studies disagreed with the case control studies, but failed to clearly articulate his interpretation of that discrepancy.

At the end of the day, it is not at all surprising that multiple confounded and biased studies all demonstrate the same association. To truly demonstrate the criterion of consistency, one must show that the same results are obtained when using different study methods. Indeed, when a different study design is utilized (cohort studies), the association vanishes. One can posit methodological flaws in the cohort studies (misclassification bias as was repeatedly stated by plaintiff counsel), but flaws can also be posited for the case control studies (recall bias and confounding). The point is that repeating the same poorly conceived study design over and over does not constitute consistency and that the criterion of consistency is therefore not met in this data set.

An example, such as the strong relationship between Vitamin A and cancer prevention might have helped. In observational studies, Vitamin A is clearly associated with a reduction of lung cancer rates based on multiple observational studies. When the claim was tested in randomized clinical trials, the claim failed miserably; indeed, Vitamin A might even increase the rate of lung malignancies in those who took supplements. Similarly, hormone replacement therapy (HRT) was once thought to decrease the risk of cardiovascular disease based on multiple observational studies. It was not until a large randomized controlled trial was conducted that the putative association between HRT and cardiovascular benefit was discredited.

5. Do not let conflict of interest arguments cloud the causal inference assessment

Alleged conflicts of interest were raised repeatedly in accusatory tones, suggesting that any research that J & J funded could not be trusted. Furthermore, suggestions were made that J & J controlled where funding was allocated through their contributions to the National Institutes of Health. These arguments must be addressed aggressively and should not be allowed to hang in the air without response.

6. Pathological evidence must be confronted by someone who studied the pathology slides

Plaintiff counsel confronted Dr. Huh with allegations by plaintiff’s pathologist about the type of cancer from which plaintiff suffered. Because Dr. Huh is not a pathologist and because he did not look at plaintiff’s pathology sides, he attempted to use his clinical impressions and medical records to counter the pathological evidence offered by the plaintiff’s expert witness in pathology. The defense seemed enamored of a “less is more” strategy, but forcing expert witnesses into testimony beyond their expertise requires fortitude and perhaps luck.

7. Put “authoritative”statements into appropriate context

Throughout his cross examination, plaintiff’s counsel confronted Dr. Huh with statements from web sites and textbooks suggesting that talc caused ovarian cancer or where talc is listed as a risk factor for ovarian cancer. Many times, such statements referred to a putative association as opposed to a causal relationship. It is critical to point out their inherent weaknesses, including the fact that they have been cherry picked and to counter with other authoritative sources where talc is not listed as a risk factor and/or the causal link has been questioned. It is also important to be ready with other risk factors that could be equally likely to be linked to ovarian cancer and to emphasize that focusing on talc is arbitrary. The plaintiff is this recent trial was morbidly obese, an undisputed risk factor for ovarian cancer.

As with the lack of consistency argument (#3, above), rebuttal of this contention would be effectively guided using specific examples. For instance, many textbooks and other authoritative sources stated that HRT had cardiovascular benefits based on multiple observational studies. The fact is that these statements were wrong.

8. Concede that cohort studies are not always better than case-control studies

The talc defense strongly asserted the view that cohort studies are necessarily better than case control studies. While this contention is generally true (all factors being equal), it is not always true and it leads to some effective cross examination (e.g., the general assertion that cohort studies may suffer, in some instances, from misclassification bias). As one of us (NAS) stated in a recent post related to the California Science Day hearings, there is no reason to make the blanket statement that cohort studies are always better than case control studies.

Rather, the general point can be made that each study type has its appropriate use and that in this case, the findings from studies using the two different methodologies do not agree with each other. Clearly, the role of differential recall is just as likely to bias a case control study as the role of misclassification is to bias a cohort study. This leaves the evidence at a draw at best.

9. Provide a multi-disciplinary defense

In a case involving so many complex disciplines, it does not seem tenable to address all of them with a single expert, even one as well qualified and experienced as Dr. Huh. Many defense lawyers firmly believe in the “less is more” strategy, but complex scientific data sets such as these necessitate a complete presentation of the exculpatory evidence. Although it is easy in hindsight to criticize trial strategy, forcing a clinical oncologist to address pathology, toxicology, and epidemiology places an unfair burden on the lone witness. Certainly, a jury may be more prone to view an expert witness, who is willing to testify outside his area of expertise, as a hired gun advocate.

10. Careful and consistent use of terminology

Because of the nuanced nature of the defense case (i.e., statistically significant associations demonstrated in observational studies may not be causal in nature), it is critical to use terms consistently and carefully. Terms such as “association,” “link,” “causal inference,” and “causation” must be carefully defined and utilized judiciously and with clear intent.

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Of course, looking at testimony in hind-sight is always 20/20. As stated at the outset of this piece defending the assertion that an exposure is not causally related to a clearly defined injury is one of the most difficult things to do in the courtroom, especially when this is attempted through a single expert witness and there are numerous studies purporting to make such a link. Nevertheless, some extremely critical lessons can be learned from this experience to guide future cases.