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Slemp Trial Part 4 – Graham Colditz

July 22nd, 2017

The Witness

Somehow, in opposition to two epidemiologists presented by the plaintiff in Slemp, the defense managed to call none. The first of the plaintiffs’ two epidemiology expert witnesses was Graham A. Colditz, a physician with doctoral level training in epidemiology. For many years, Colditz was a professor at the Harvard School of Public Health. Colditz left Harvard to become the Niess-Gain Professor at Washington University St. Louis School of Medicine, where he is also the Associate Director for Prevention and Control at the Alvin J. Siteman Cancer Center.

Colditz is a senior epidemiologist, with many book and article publications to his credit. Although he has not published a causal analysis of ovarian cancer and talc, Colditz was an investigator on the well-known Nurses’ Health Study. One of Colditz’s publications on the Nurses’ cohort featured an analysis of talc use and ovarian cancer outcomes.

Although he is not a frequent testifying expert witness, Colditz is no stranger to the courtroom. He was a regular protagonist in the estrogen-progestin hormone replacement therapy (HRT) litigation, which principally involves claims of female breast cancer. Colditz has a charming Australian accent, with a voice tremor that makes him sound older than 63, and perhaps even more distinguished. He charges $1,500 per hour for his testimonial efforts, but is quick to point out that he has given thousands to charity. At his hourly rate, we can be sure he needs tax deductions of some kind.

In discussing his own qualifications, Colditz was low-key and modest except for what seemed like a strange claim that his HRT litigation work for plaintiffs led the FDA to require a boxed warning of breast cancer risk on the package insert for HRT medications. This claim is certainly false, and an extreme instance of post hoc ergo propter hoc. Colditz gilded the lilly by claiming that he does not get involved unless he believes that general causation exists between the exposure or medication and the disease claimed. Since he has only been a plaintiffs’ expert witness, this self-serving claim is quite circular.

The Examinations

The direct and cross-examinations of Dr. Colditz were long and tedious. Most lawyers are reluctant to have an epidemiologists testify at all, and try to limit the length of their examinations, when they must present epidemiologic testimony. Indeed, the defense in Slemp may have opted to present a clinician based upon the prejudice against epidemiologists testifying about quantitative data and analysis. In any event, Colditz’s direct examination went not hours, but days, as did the defense’s cross-examination.

The tedium of the direct examination was exacerbated by the shameless use of leading, loaded, and argumentative questions by plaintiff’s counsel, Allen Smith. A linguistic analysis might well show that Smith spoke 25 to 30 words for every one word spoken by Colditz on direct examination. Even aside from the niceties of courtroom procedure, the direct examination was lacking in aesthetic qualities. Still, it is hard to argue with a $110 million verdict, which cries out for explanation.

There were virtually no objections to Smith’s testifying in lieu of Colditz, with Colditz reduced to just “yes.” Sometimes, Colditz waxed loquacious, and answered, “yes, sir.” From judicial responses to other objections, however, it was clear that the trial court would have provided little control of the leading and argumentative questions.

Smith’s examination also took Colditz beyond the scope of his epidemiologic expertise in to ethics, social policy, and legal requirements of warnings, again without judicial management or control. We learned, over objection, from Colditz of all witnesses that the determination of causation has nothing to do with whether a warning should be given.

The Subject Matter

Colditz was clearly familiar with the subject matter, and allowed Smith to testify for him on a fairly simplistic level. The testimony was a natural outgrowth of his professional interests, and Colditz must have appeared to have been a credible expert witness, especially in a St. Louis courtroom, given that he was in a leadership role at the leading cancer center in that city.

With Smith’s lead, Colditz broached technical issues of bias evaluation, meta-analysis and pooling, which would never be addressed later by a defense expert witness at an equal level of expertise, sophistication, and credibility. Colditz offered criticisms of the Gonzalez (Sister Study) and the latency built into the observation period of that cohort, and he introduced the concept of Berkson bias in some of the case-control studies. Neither of these particular criticisms was rebutted in the defense case, again raising the question whether the defense expert witness, Dr. Huh, a clinician specializing in gynecologic oncology, was an appropriate foil for the line up of plaintiffs’ expert witness. Dr. Colditz was able to talk authoritatively (and in some cases misleadingly) about issues, which Dr. Huh could not contradict effectively, even if he were to have tried.

Colditz characterized his involvement in the talc cases as starting with his conducting a systematic review, undertaken for litigation, but still systematic. As a professor of epidemiology, Colditz should know what a systematic review is, although he never fully described the process on either direct or cross-examinations. No protocol for the systematic review was adduced into evidence. Sadly, the defense expert witness, Dr. Huh, never stated that he had done a systematic review; nor did he offer any criticisms of Dr. Colditz’s systematic review. Indeed, Huh admitted that he had not read Colditz’s testimony. In general, observing Colditz’s testimony after having watched Dr. Huh testify shouted MISMATCH.

The Issues

Statistical Significance

The beginning point of a case such as Slemp, involving a claim that talc causes ovarian cancer, and that it caused her ovarian cancer, is whether there is supporting epidemiology for the claim. As Sir Austin Bradford Hill put it over 50 years ago:

“Disregarding then any such problem in semantics we have this situation. Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance. What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965). Colditz, and plaintiff’s counsel, did not run away from the challenge; they embraced statistical significance and presented an argument for why the association was “clear-cut” (not created by bias or confounding).

In one of his lengthy, leading questions, plaintiffs’ counsel attempted to suggest that statistical significance, or a confidence interval that excluded a risk ratio of 1.0, excluded bias as well as chance. Colditz to his credit broke from the straight jacket of “yes, sirs,” and disagreed as to bias. Smith, perhaps chastised then took a chance and asked an open-ended question about what a confidence interval was. With the bit in his mouth, Colditz managed to describe the observed confidence interval incorrectly as providing the range within which the point estimate would fall 95% of the time if the same study were repeated many times! There is a distribution of 95% confidence intervals, which cover the true parameter 95% of the time, assuming a correct statistical model, random sampling, and no bias or confounding. For the observed confidence interval, the true value is either included or not. Perhaps Colditz was thinking of a prediction interval, but Smith had asked for a definition of a confidence interval, and the jury got non-sense.

Dose Response

Colditz parsed the remaining Bradford Hill factors, and opined that exposure-gradient or dose response was good to have but not necessary to support a causal conclusion. Colditz opined, with respect to whether the statistical assessment of a putative dose-response should include non-exposed women, that the non-exposed women should be excluded. This was one of the few technical issues that Dr. Huh engaged with, in the defense case, but Dr. Colditz was not confronted with any textbooks or writings that cast doubt on his preference for excluding non-users.

Plausibility

Plaintiff’s counsel spent a great deal of time, mostly reading lengthy passages of articles on this or that plausible mechanism for talc’s causing human ovarian cancer, only to have Colditz, with little or no demonstrated expertise in biological mechanism, say “yes.” Some articles discussed that talc use was a modifiable risk and that avoiding perineal talc use “may” reduce ovarian cancer risk. Smith would read (accurately) and then ask Colditz whether he agreed that avoiding talc use would reduce ovarian cancer in women. Colditz himself catches and corrects Smith, some times, but not others.

Smith read from an article that invokes a claim that asbestos (with definition as to what mineral) causes ovarian cancer. Colditz agreed. Smith testified that talc has asbestos in it, and Colditz agreed. Smith read from an article that stated vaguely that talc is chemically similar to asbestos and thus this creates plausibility for a causal connection between talc and cancer. Colditz agreed, without any suggestion that he understands whether or not talc is morphologically similar to asbestos. It seems unlikely that Colditz had any real expertise to offer here, but Smith could not resist touching all bases with Colditz; and the defense did not object or follow up on these excesses.

Smith and Colditz, well mostly Smith, testified that tubal ligation reduces the otherwise observed increased risk of ovarian cancer from talc use. Smith here entrusts Colditz with providing the common-sense explanation. There is no meaningful cross-examination on this “jury friendly” point.

Consistency

Colditz testifed that the studies, both case-control and cohort studies, were consistent in showing an increased risk of ovarian cancer in association with talc use. Indeed, the studies are mostly consistent; the issue is whether they are consistently biased or consistently showing the true population risk. The defense chose to confront Colditz with the lack of statistical significance in some studies (with elevated risk ratios) as though these studies were inconsistent with the studies that found similar risk ratios, with p-values less than 5%. This confrontation did not go well for the defense, either on cross-examination of Colditz, or on direct examination of Dr. Huh. Colditz backed up his opinion on consistency with the available meta-analyses, which find very low p-values for the summary estimate of risk ratio for talc use and ovarian cancer.

Unlike the Zoloft case¹, in which consistency was generated across different end points by cherry picking, the consistency in the talc case was evidenced by a consistent elevation of risk ratios for the same end point, across studies. When subgroups of ovarian cell or tumor types were examined, statistical significance was sometimes lost, but the direction of the risk ratio above one was maintained. Meta-analyses generated summary point estimates with very low p-values.

The Gold Standard

Colditz further gilded the consistency lilly by claiming that the Terry study², a pooled analysis of available case-control studies, was the “gold standard” in this area of observational epidemiology. Smith and Colditz presented at some length as to how the Cochrane Collaboration has labeled combined “individual patient data” (IPD) analyses as the gold standard. Colditz skimmed over the Cochrane’s endorsement of IPD analyses as having been made in the context of systematic reviews, involving primarily randomized clinical trials, for which IPD analyses allow time-to-event measurements, which can substantially modify observed risk ratios, and even reverse their direction. The case-control studies in the Terry pooled analysis did not have anything like the kind of prospectively collected individual patient data, which would warrant holding the Terry paper up as a “gold standard,” and Terry and her co-authors never made such a claim for their analysis. Colditz’s claim about the Terry study cried out for strong rebuttal, which never came.

The defense should have known that this hyperbolic testimony would be forthcoming, but they seemed not to have a rebuttal planned, other than dismissing case-controls studies generally as smaller than cohort studies. Rather than “getting into the weeds” about the merits of pooled analyses of observational studies, as opposed to clinical trials, the defense continued with its bizarre stance that the cohort studies were better because larger, while ignoring that they are smaller with respect to number of ovarian cancer cases and have less precision than the case-control studies. See “New Jersey Kemps Ovarian Cancer – Talc Cases” (Sept. 16, 2016). The defense also largely ignored Colditz’s testimony that exposure data collected in the available cohort studies was of limited value because lacking in details about frequency and intensity of use, and in some cases, collected on only one occasion.

Specific Causation

Colditz disclaimed the ability or intention to offer a specific causation opinion about Ms. Slemp’s ovarian cancer. Nonetheless, Colditz volunteered that “cancer is multifactorial,” which says very little because it says so much. In plaintiffs’ counsel’s hands, this characterization became a smokescreen to indict every possible present risk factor as playing a part in the actual causation of a particular case, such as Ms. Slemp’s case. No matter that the plaintiff was massively obese, and a smoker; every risk factor present must be, by fiat, in the “causal pie.”

But this would seem not to be Colditz’s own opinion. Graham Colditz has elsewhere asserted that an increased risk of disease cannot be translated into the “but-for” standard of causation³:

“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.”

Just because a risk factor (assuming it is real and causal) is present does not put in the causal set.

Cross-Examination

The direct examination of Graham Colditz included scurrilous attacks on J & J’s lobbying, paying FDA user fees, and other corporate conduct, based upon documents of which Colditz had not personal knowledge. Colditz was reduced to nothing more than a backboard, off which plaintiff’s counsel could make his shots. On cross, the defense carefully dissected this direct examination and obtained disavowals from Colditz that he had suggested any untoward conduct by J & J. The jury could have been spared their valuable time by a trial judge who did not allow the scurrilous, collateral attacks in the first place.

The defense also tried to diminish Dr. Colditz’s testimony as an opinion coming from a non-physician. The problem, however, was that Colditz is a physician, who understands the biological issues, even if he is not a pathologist, toxicologist, or oncologist. Colditz did not offer opinions about Slemp’s medical treatment, and there was nothing in this line of cross-examination that lessened the impact of Colditz’s general causation testimony.

Generally, the cross-examination did not hurt Dr. Colditz’s strongly stated opinion that talc causes ovarian cancer. The defense (and plaintiff’s counsel before them) spent an inordinate amount of time on why Dr. Colditz has not updated his website to state publicly that talc causes ovarian cancer. Colditz blamed the “IT” guys, a rather disingenuous excuse. His explanation on direct, and on cross, as to why he could not post his opinion on his public-service website was so convoluted, however, that there was no clear admission or inference of dereliction. Colditz was permitted to bill his opinion, never posted to his institution’s website, as a “consensus opinion,” endorsed by several researchers, based upon hearsay emails and oral conversations.

1 See 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 opinion, which involved changing subgroup end points across studies of maternal sertraline use and infant cardiac birth defects ).

2 Kathryn L. Terry, et al., “Genital powder use and risk of ovarian cancer: a pooled analysis of 8,525 cases and 9,859 controls,” 6 Cancer Prev. & Research 811 (2013).

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

Posted in Causation, Meta-analysis, Scientific Evidence | Comments Off on Slemp Trial Part 4 – Graham Colditz

Slemp Trial Part 3 – The Defense Expert Witness – Huh

July 9th, 2017

On June 19, 2017, the U.S. Supreme Court curtailed the predatory jurisdictional practices of the lawsuit industry in seeking out favorable trial courts with no meaningful connection to their claims. See Bristol-Myers Squib Co. v. Superior Court, No. 16-466, 582 U.S. ___ (June 19, 2017). The same day, the defendants in a pending talc cancer case in St. Louis filed a motion for a mistrial. Swann v. Johnson & Johnson, Case No. 1422-CC09326-01, Division 10, Circuit Court of St. Louis City, Missouri. Missouri law may protect St. Louis judges from having to get involved in gatekeeping scientific expert witness testimony, but when the Supreme Court speaks to the requirements of the federal constitution’s due process clause, even St. Louis judges must listen. Bristol-Myers held that the constitution limits the practice of suing defendants in jurisdictions unrelated to the asserted claims, and the St. Louis trial judge, Judge Rex Burlison, granted the requested mistrial in Swann. As a result, there will not be another test of plaintiffs’ claims that talc causes ovarian cancer, and the previous Slemp case will remain an important event to interpret.

The Sole Defense Expert Witness

Previous posts¹ addressed some of the big picture issues as well as the opening statements in Slemp. This posts turns to the defense expert witness, Dr. Walter Huh, in an attempt to understand how and why the jury returned its egregious verdict. Juries can, of course, act out of sympathy, passion, or prejudice, but their verdicts are usually black boxes when it comes to discerning their motivations and analyses. A more interesting and fruitful exercise is to ask whether a reasonable jury could have reached the conclusion in the case. The value of this exercise is limited, however. A reasonable jury should have reasonable expertise in the subject matter, and in our civil litigation system, this premise is usually not satisfied.

Dr. Walter Huh, a gynecologic oncologist, was the only expert witness who testified for the defense. As the only defense witness, and as a clinician, Huh had a terrible burden. He had to meet and rebut testimony outside his fields of expertise, including pathology, toxicology, and most important, epidemiology. Huh was by all measures well-spoken, articulate, and well-qualified as a clinical gynecologic oncologist. Defense counsel and Huh, however, tried to make the case that Huh was qualified to speak to all issues in the case. The initial examination on qualifications was long and tedious, and seemed to overcompensate for the obvious gaps in Dr. Huh’s qualifications. In my view, the defense never presented much in the way of credible explanations about where Huh had obtained the training, experience, and expertise to weigh in on areas outside clinical medicine. Ultimately, the cross-examination is the crucial test of whether this strategy of one witness for all subjects can hold. The cross-examination of Dr. Huh, however, exposed the gaps in qualifications, and more important, Dr. Huh made substantive errors that were unnecessary and unhelpful to the defense of the case.

The defense pitched the notion that Dr. Huh somehow trumped all the expert witnesses called by plaintiff because Huh was the “only physician heard by the jury” in court. Somehow, I wonder whether the jury was so naïve. It seems like a poor strategic choice to hope that the biases of the jury in favor of the omniscience of physicians (over scientists) will carry the day.

There were, to be sure, some difficult clinical issues, on which Dr. Huh could address within his competence. Cancer causation itself is a multi-disciplinary science, but in the case of a disease, such as ovarian cancer, with a substantial base-rate in the general population and without any biomarker of a causal pathway between exposure and outcome, epidemiology will be a necessary tool. Huh was thus forced to “play” on the plaintiffs’ expert witnesses’ home court, much to his detriment.

General Causation

Don’t confuse causation with links, association, and risk factors

The defense strong point is that virtually no one, other than the plaintiffs’ expert witnesses themselves, and only in the context of litigation, has causally attributed ovarian cancer to talc exposure. There are, however, some ways that this point can be dulled in the rough and tumble of trial. Lawyers, like journalists, and even some imprecise scientists, use a variety of terms such as “risk,” “risk factor,” “increased risk,” and “link,” for something less than causation. Sometimes these terms are used deliberately to try to pass off something less than causation as causation; sometimes the speaker is confused; and sometimes the speaker is simply being imprecise. It seems incumbent upon the defense to explain the differences between and among these terms, and to stick with a consistent, appropriate terminology.

One instance in which Dr. Huh took his eye off the “causation ball,” arose when plaintiffs’ counsel showed him a study conclusion that talc use among African American women was statistically significantly associated with ovarian cancer. Huh answered, non-responsively, “I disagree with the concept that talc causes ovarian cancer.” The study, however, did not advance a causal conclusion and there was no reason to suggest to the jury that he disagreed with anything in the paper; rather it was the opportunity to repeat that association is not causation, and the article did not contradict anything he had said.

Similarly, Dr. Huh was confronted with several precautionary recommendations that women “may” benefit from avoiding talc. Remarkably, Huh simply disagreed, rather than making the obvious point that the recommendation was not stated as something that would in fact benefit women.

When witnesses answer long, involved questions, with a simple “yes,” then they may have made every implied proposition in the questions into facts in the case. In an exchange between plaintiff’s counsel and Huh, counsel asked whether a textbook listed talc as a risk factor.² Huh struggled to disagree, which disagreement tended to impair his credibility, for disagreeing with a textbook he acknowledged using and relying upon. Disagreement, however, was not necessary; the text merely stated that “talc … may increase risk.” If “increased risk” had been defined and explained as something substantially below causation, then Huh could have answered simply “yes, but that quotation does not support a causal claim.”

At another point, plaintiffs’ counsel, realizing that none of the individual studies reached a causal conclusion, asked whether it would be improper for a single study to give such a conclusion. It was a good question, with a solid premise, but Dr. Huh missed the opportunity for explaining that the authors of all the various individual studies had not conducted systematic reviews that advanced the causal conclusion that plaintiffs would need. Certainly, the authors of individual studies were not prohibited from taking the next step to advance a causal conclusion in a separate paper with the appropriate analysis.

Bradford Hill’s Factors

Dr. Huh’s testimony provided the jury with some understanding of Sir Austin Bradford Hill’s nine factors, but Dr. Huh would have helped himself by acknowledging several important points. First, as Hill explained, the nine factors are invoked only after there is a clear-cut (valid) association beyond that which we care to attribute to chance. Second, establishing all nine factors is not necessary. Third, some of the nine factors are more important than others.

Study validity

In the epidemiology of talc and ovarian cancer, statistical power and significance are not the crucial issues; study validity is. It should have been the plaintiff’s burden to rule out bias, and confounding, as well as chance. Hours had passed in the defense examination of Dr. Huh before study validity was raised, and it was never comprehensively explained. Dr. Huh explained recall bias as a particular problem of case-control studies, which made up the bulk of evidence upon which plaintiffs’ expert witnesses relied. A more sophisticated witness on epidemiology might well have explained that the selection of controls can be a serious problem without obvious solutions in case-control studies.

On cross-examination, plaintiffs’ counsel, citing Kenneth Rothman, asked whether misclassification bias always yields a lower risk ratio. Dr. Huh resisted with “not necessarily,” but failed to dig in whether the conditions for rejecting plaintiffs’ generalization (such as polychotomous exposure classification) obtained in the relevant cohort studies. More importantly, Huh missed the opportunity to point out that the most recent, most sophisticated cohort study reported a risk ratio below 1.0, which on the plaintiffs’ theory about misclassification would have been even lower than 1.0 than reported in the published paper. Again, a qualified epidemiologist would not have failed to make these points.

Dr. Huh never read the testimony of one of the plaintiffs’ expert witnesses on epidemiology, Graham Colditz, and offered no specific rebuttal of Colditz’s opinions. With respect to the other of plaintiffs’ epidemiology expert witness, Dr. Cramer, Huh criticized him for engaging in post-hoc secondary analyses and asserted that Cramer’s meta-analysis could not be validated. Huh never attempted to validate the meta-analysis himself; nor did Huh offer his own meta-analysis or explain why a meta-analysis of seriously biased studies was unhelpful. These omissions substantially blunted Huh’s criticisms.

On the issue of study validity, Dr. Huh seem to intimate that cohort studies were necessarily better than case-control studies because of recall bias, but also because there are more women involved in the cohort studies than in the case-control studies. The latter point, although arithmetically correct, is epidemiologically bogus. There are often fewer ovarian cancer cases in the cohort study, especially if the cohort is not followed for a very long time. The true test comes in the statistical precision of the point estimate, relative risk or odds ratio, in the different type of study. The case-control studies often generate much more precise point estimates as seen from their narrower confidence intervals. Of course, the real issue is not precision here, but accuracy. Still, Dr. Huh appeared to have endorsed the defense counsel misleading argument about study size, a consideration that will not help the defense when the contentions of the parties are heard in scientific fora.

Statistical Significance

Huh appeared at times to stake out a position that if a study does not have statistical significance, then we must accept the null hypothesis. I believe that most careful scientists would reject this position. Null studies simply fail to reject the null hypothesis.

Although there seems to be no end to fallacious reasoning by plaintiffs, there is a particular defense fallacy seen in some cases that turn on epidemiology. What if we had 10 studies that each found an elevated risk ratio of 1.5, with two-tailed 95 percent confidence intervals of 0.92 – 2.18, or so. Can the defense claim victory because no study is statistically significant? Huh seemed to suggest so, but this is clearly wrong. Of course, we might ask why no one conducted the 11^th study, with sufficient power to detect a risk ratio of 1.5, at the desired level of significance. But parties go to trial with the evidence they have, not what they might want to have. On the above 10-study hypothetical, a meta-analysis might well be done (assuming the studies could be appropriately included), and the summary risk ratio for all studies would be 1.5, and highly statistically significant.

On the question of talc and ovarian cancer, there were several meta-analyses at issue, and so the role of statistical significance of individual studies was less relevant. The real issue was study validity. This issue was muddled by assertions that risk ratios such as 2.05 (95%, 0.94 – 4.47) were “chance findings.” Chance may not have been ruled out, but the defense can hardly assert that chance and chance alone produced the findings; otherwise, it will be sunk by the available meta-analyses.

Strength of Association

The risk ratios involved in most of the talc ovarian cancer studies are small, and that is obviously an important factor to consider in evaluating the studies for causal conclusions. Still, it is also obvious that sometimes real causal associations can be small in magnitude. Dr Huh could and should have conceded in direct that small associations can be causal, but explained that validity concerns about the studies that show small associations become critical. Examples would have helped, such as the body of observational epidemiology that suggested that estrogen replacement therapy in post-menopausal women provided cardiovascular benefit, only to be reversed by higher quality clinical trials. Similarly, observational studies suggested that lung cancer rates were reduced by Vitamin A intake, but again clinical trial data showed the opposite.

Consistency of Studies

Are studies that have statistically non-significant risk ratios above 1.0 inconsistent with studies that find statistically significant elevated risk ratios? At several points, Huh appears to say that such a group of studies is inconsistent, but that is not necessarily so. Huh’s assertion provoked a good bit of harmful cross-examination, in which he seemed to resist the notion that meta-analysis could help answer whether a group of studies is statistically consistent. Huh could have conceded the point readily but emphasized that a group of biased studies would give only a consistently biased estimate of association.

Authority

One of the cheapest tricks in the trial lawyers’ briefcase is the “learned treatise” exception to the rule against hearsay.”³ The lawyer sets up witnesses in deposition by obtaining their agreement that a particular author or text is “authoritative.” Then at trial, the lawyer confronts the witnesses with a snippet of text, which appears to disagree with the expert witnesses’ testimony. Under the rule, in federal and in some state courts, the jury may accept the snippet or sound bite as true, and also accept that the witnesses do not know what they are talking about when they disagree with the “authoritative” text.

The rule is problematic and should have been retired long ago. Since 1663, the Royal Society has sported the motto: “Nullius in verba.” Disputes in science are resolved with data, from high-quality, reproducible experimental or observational studies, not with appeals to the prestige of the speaker. And yet, we lawyers will try, and sometimes succeed, with this greasy kidstuff approach cross-examination. Indeed, when there is an opportunity to use it, we may even have an obligation to use so-called learned treatises to advance our clients’ cause.

In the Slemp trial, the plaintiff’s counsel apparently had gotten a concession from Dr. Huh that plaintiff’s expert witness on epidemiology, Dr. Daniel Cramer, was “credible and authoritative.” Plaintiff’s counsel then used Huh’s disagreement with Cramer’s testimony as well as his published papers to undermine Huh’s credibility.

This attack on Huh was a self-inflicted wound. The proper response to a request for a concession that someone or some publication is “authoritative,” is that this word really has no meaning in science. “Nullius in verba,” and all that. Sure, someone can be a respected research based upon past success, but past performance is no guarantee of future success. Look at Linus Pauling and Vitamin C. The truth of a conclusion rests on the data and the soundness of the inferences therefrom.

Collateral Attacks

The plaintiff’s lawyer in Slemp was particularly adept at another propaganda routine – attacking the witness on the stand for having cited another witness, whose credibility in turn was attacked by someone else, even if that someone else was a crackpot. Senator McCarthy (Joseph not Eugene) would have been proud of plaintiff’s lawyer’s use of the scurrilous attack on Paolo Boffetta for his views on EMF and cancer, as set out in Microwave News, a fringe publication that advances EMF-cancer claims. Now, the claim that non-ionizing radiation causes cancer has not met with much if any acceptance, and Boffetta’s criticisms of the claims are hardly unique or unsupported. Yet plaintiff’s counsel used this throw-away publication’s characterization of Boffetta as “the devil’s advocate,” to impugn Boffetta’s publications and opinions on EMF, as well as Huh’s opinions that relied upon some aspect of Boffetta’s work on talc. Not that “authority” counts, but Boffetta is the Associate Director for Population Sciences of the Tisch Cancer Institute and Chief of the Division of Cancer Prevention and Control of the Department of Oncological Sciences, at the Mt. Sinai School of Medicine in New York. He has published many epidemiologic studies, as well as a textbook on the epidemiology of cancer.⁴

The author from the Microwave News was never identified, but almost certainly lacks the training, experience, and expertise of Paolo Boffetta. The point, however, is that this cross-examination was extremely collateral, had nothing to do with Huh, or the issues in the Slemp case, and warranted an objection and admonition to plaintiff’s counsel for the scurrilous attack. An alert trial judge, who cared about substantial justice, might have shut down this frivolous, highly collateral attack, sua sponte. When Huh was confronted with the “devil’s advocate” characterization, he responded “OK,” seemingly affirming the premise of the question.

Specific Causation

Dr. Huh and the talc defendants took the position that epidemiology never informs assessment of individual causation. This opinion is hard to sustain. Elevated risk ratios reflect more individual cases than expected in a sample. Epidemiologic models are used to make individual predictions of risk for purposes of clinical monitoring and treatment. Population-based statistics are used to define range of normal function and to assess individuals as impaired or disabled, or not.

At one point in the cross-examination, plaintiffs’ counsel suggested the irrelevance of the size of relative risk by asking whether Dr. Huh would agree that a 20% increased risk was not small if you are someone who has gotten the disease. Huh answered “Well, if it is a real association.” This answer fails on several levels. First, it conflates “increased risk” and “real association” with causation. The point was for Huh to explain that an increased risk, if statistically significant, may be an association, but it is not necessary causal.

Second, and equally important, Huh missed the opportunity to explain that even if the 20% increased risk was real and causal, it would still mean that an individual patient’s ovarian cancer was most likely not caused by the exposure. See David H. Schwartz, “The Importance of Attributable Risk in Toxic Tort Litigation,” (July 5, 2017).

Conclusion

The defense strategy of eliciting all their scientific and medical testimony from a single witness was dangerous at best. As good a clinician as Dr. Huh appears to be, the defense strategy did not bode well for a good outcome when many of the scientific issues were outside of Dr. Huh’s expertise.

1 “The Slemp Case, Part I – Jury Verdict for Plaintiff – 10 Initial Observations” (May 13, 2017); The Slemp Case, Part 2 – Openings (June 10, 2017).

2 Jonathan S. Berek & Neville F. Hacker, Gynecologic Oncology at 231 (6th ed. 2014).

3 See “Trust-Me Rules of Evidence” (Oct. 18 2012).

4 See, e.g., Paolo Boffetta, Stefania Boccia, Carol La Vecchia, A Quick Guide to Cancer Epidemiology (2014).

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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

Belgian Waffles and Post Hoc Ergo Propter Hoc

June 22nd, 2017

In language that could well be a Sokol hoax on the vacuousness of post-modernist non-thinking, the Court of Justice of the European Union issued a press release to announce its judgment in N.W. v. Sanofi Pasteur MSD, Case C-621/15 (Luxembourg, 21 June 2017). With European hypersensitivity to public disclosure, and in recognition of the right to be forgotten, the plaintiffs are known only as the “W” family. Mr. J. W. received Sanofi’s hepatitis B vaccine between late 1998 and the middle of 1999. In the summer of 1999, Mr. W. began to experience symptoms, which led to a diagnosis of multiple sclerosis over a year later, in November 2000. J.W. and his family sued Sanofi Pasteur in 2006. J.W. died in 2012.

The Ws filed their case in Paris, where the courts found for Sanofi Pasteur. The Cour d’Appel de Paris, impressed by the lack of scientific consensus to support W’s causal claim, held that the plaintiffs had failed to demonstrate causality. The Cour d’Appel de Paris court dismissed the W’s case. The dismissal was remarkable in the context of credulous French courts that had routinely recognized such claims. See C. Rougé-Maillart, N. Guillaume, N. Jousset, and M, Penneau, “Recognition by French courts of compensation for post-vaccination multiple sclerosis: the consequences with regard to expert practice,”47 Med. Sci. Law 185 (2007) (summarizing the course of M.S. and hepatitis B vaccination litigation in France). The Ws appealed further to the French Cour de Cassation (Court of Cassation), which punted to the EU Court of Justice, to ask whether the EU directive on liability for defective products required a different result than handed down by the Cour d’Appel.

The “Court of Justice” stated that the claimants had the burden of proof, but dubiously framed the causation issue as a choice between “certain and irrefutable evidence” and evidence of a “sufficiently high degree of probability.” What gives rise to sufficiently high degree of probability? In bold type, the EU press release announces that:

“Where there is a lack of scientific consensus, the proof of the defect of the vaccine and of a causal link between the defect and the damage suffered may be made out by serious, specific and consistent evidence.”

But what is “serious, specific, and consistent evidence”? Scouring both the press release and the full decision of the Court provides one answer:

Anecdotes. Unspecified number of case reports of multiple sclerosis occurring in patients after vaccination, without regard to an anticipated or expected incidence of the disease in the vaccinated population suffices. The Court of Justice sums up the Ws’ case as a showing that:

“The temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of the person vaccinated and the existence of a significant number of reported cases of the disease occurring following such vaccines being administered may, where applicable, constitute sufficient evidence to make out such proof.”

The significant number of cases is never quantified or even described. The “sufficiently high probability” is never quantified or described. Presumably, the judges in Brussels can count, and the probability is some number greater than zero, but less than 1. The Court of Justice follows many other lay courts in falsely dichotomizing scientific disputes as involving either “certain, irrefutable” evidence or something less, and good enough for government (judicial) work. Even its representation of the Ws’ evidence as “serious, specific and consistent” and its suggestion of a “sufficiently high” probability are false, at least without spelling out the evidentiary base of the anecdotal evidence that is elevated to legally sufficient in the eyes of the Court of Justice. The Court fails to acknowledge, as a Court of Justice should, that large, high quality epidemiologic studies fail to find associations between hepatitis B vaccination and multiple sclerosis. See, e.g., Annette Langer-Gould, Lei Qian, Sara Y. Tartof, PhD; Sonu M. Brara, Steve J. Jacobsen, Brandon E. Beaber, Lina S. Sy, Chun Chao, Rulin Hechter, Hung Fu Tseng, “Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases,” 71 J. Am. Med. Ass’n Neurol. 1506 (2014); Miguel A. Hernán & Susan S. Jick, “Hepatitis B vaccination and multiple sclerosis: the jury is still out,” 15 Pharmacoepidemiology & Drug Safety 653 (2006).

The European right to be forgotten has apparently been extended to scientific evidence. There may be reasons more legitimate than racist xenophobia to exit the European Union.

Posted in Causation, Scientific Evidence | Comments Off on Belgian Waffles and Post Hoc Ergo Propter Hoc

The Slemp Case, Part 2 – Openings

June 10th, 2017

“The Slemp Case, Part I – Jury Verdict for Plaintiff – 10 Initial Observations” (May 13, 2017)

The legal community is still trying to grasp the enormity of the $110M verdict against Johnson & Johnson, in the Slemp case. J & J says it will appeal, but resolution of legal issues will not necessarily clarify what happened factually in the Slemp case. Some legal commentators have attempted superficial analyses that try to correlate case outcomes with how cases are selected for trial in Missouri. In the five talc trials to date, plaintiffs have prevailed (with fulsome verdicts) in both cases in which plaintiffs’ counsel selected the case for trial. See Amy Rubenstein and Malerie Ma Roddy, “Talc Talk: 1 Of These Verdicts Is Not Like The Others,” Law360 (June 1, 2017). In the three other cases, selected by defense counsel, the defense has lost two of the three cases, again with outlandish verdicts. No statistical analysis of these correlations will suggest that the selection process is correlated with verdict outcome. If there is no general causation, then selection of plaintiff for trial should not correlate with outcome. More important, the Missouri verdicts cannot be reconciled with the ruling by Judge Johnson in the New Jersey talc cases. Carl v. Johnson & Johnson, No. ATL-L-6546-14, 2016 WL 4580145 (N.J. Super. Ct. Law Div., Atl. Cty., Sept. 2, 2016); see also “New Jersey Kemps Ovarian Cancer – Talc Cases” (Sept. 16, 2016).

A manufacturer is legally held to the standard of having expert knowledge of the hazards of a product, and warning about those hazards that are not common knowledge. The conflicts noted above, and the exculpatory views of various professional groups and federal and international agencies should mean, in a sane system of products liability law, that a manufacturer would have no liability in the ovarian cancer – talc cases. A recent review concluded:

“While mechanistic, pathology, and animal studies do not support evidence for the carcinogenicity of talc on the ovarian epithelium 329, epidemiological studies have indicated an association with talc use and increased OC [ovarian cancer] risk.”

Brett M. Reid, Jennifer B. Permuth, Thomas A. Sellers, “Epidemiology of ovarian cancer: a review,” Cancer Biol. Med. 14 (2017). The authors went on, however, to note that the association was not consistently found among studies, and that the IARC had rejected the causal contention as having been shown. How on this evidence, can a manufacturer be held liable for not warning of a causal connection? And how could a manufacturer be found to have acted maliciously or outrageously, with substantial scientific support?

What is needed is careful, detailed evaluation of the actual evidence at trial. The International Agency for Research on Cancer (IARC), the FDA, the NTP, and virtually every other agency and professional group that has addressed the question whether talc causes ovarian cancer, have declared that there is no causal connection established. Have the plantiffs in these cases hit a treasure trove of data not seen by the scientific and regulatory community? Or have plaintiffs exploited the weaknesses of the jury system, and advanced arguments and evidence that would never move a panel of disinterested scientists?

Meaningful analyses of the talc trials are not likely to happen from hipshot commentary. Fortunately, Courtroom View Network videotaped the Slemp trial from openings to return of verdict, which has created a rich resource for lawyers, legal analysts, political scientists, scientists, and regulators to judge the efficacy and content of courtroom presentations of complex scientific evidence.

Less is More, Except When Less is Just Less

There are two common, glib pronouncements you can often hear uttered in defense counsel confabulations. The first is “Less is More.” The second is “Let’s not get into weeds.” These generalizations cannot be tested with jury research in which both sides’ presentations are often no longer than 60 minutes, or so. Actual research of trial research rarely can move beyond anecdotal observations.

In Slemp, the defense case went took up two days. The plaintiffs’ case took 12 days. The plaintiff presented multiple medical expert witnesses, including two epidemiologists who have been involved in studying talc and ovarian cancer, and publishing on the issue, for decades. The defense presented just one expert witness, Dr. Warner Huh, a gynecologic oncologist. Dr. Huh claimed to have epidemiologic expertise by virtue of his work on studies on cervical cancer screening. Dr. Huh, as we will see, never explained how, when, and where he received training in epidemiologic study design and biostatistics. This defense strategy on expert witnesses requires careful analysis. Furthermore, the plaintiffs’ counsel presented a minimally qualified regulatory expert witness to serve primarily as a document reader. The defense effectively cross-examined this witness by showing his ignorance and selectivity in document reading and presentation. J & J, however, never called a fact witness, or corporate witness, to give viva voce testimony, that rebutted the innuendo, defamations, and characterizations of the company by plaintiffs’ counsel.

The Opening “Statements”

Perhaps it is best to begin at the beginning. Voir dire is not available at Courtroom View Network, but the opening statements are on line. There is a widespread myth that Hans Zeisel’s research established that most cases are won in the openings. Zeisel debunked that reading of his work, without disagreeing that the first impressions of opening statement can be powerful. See Hans Zeisel, “A Jury Hoax: The Superpower of the Opening Statement,” 14 Litigation 17 (Summer 1988). Inquiring minds might want to know how the openings statements went for the parties involved in Slemp.

Counsel for the plaintiff and for the two defendants (J & J, Imerys) all gave strong arguments that went well beyond stating what the evidence will show. All counsel worked hard to establish ethos and pathos, but plaintiff’s counsel excelled at creating the appearance of scientific logos, even when there was none. Defense counsel, on the other hand, tried to avoid talking about epidemiology for the most part. When the defense did discuss epidemiology, they made some disturbing, unnecessary mistakes.

Plaintiffs’ Opening

The plaintiff’s opening was noteworthy for its fear mongering. There are some authors who seem to want to take credit for a so-called reptile strategy, but fear mongering has been part of the dark side of rhetoric since at least the dawn of recorded history.¹ Edmund Burke captured the sum and substance of the reptile strategy, which was so much on display in 18^th century politics:

“No passion so effectually robs the mind of all its powers of acting and reasoning as fear.”

Edmund Burke, A Philosophical Inquiry into The Origin of Our Ideas of The Sublime And Beautiful – With Several Other Additions at Sect. II. Terror (1757). Plaintiff’s counsel argued that all women, everywhere [including the women jurors and the male jurors’ female kin] are threatened by the evil corporate behemoth that sells baby powder. Women, everywhere, are developing ovarian cancer by the millions because they have used talcum powder. Only this jury can stop the carnage because regulators have ignored the situation. Regulators and the scientific establishment are venal, and J & J has bought them off. Steve Bannon would be proud.

The plaintiff’s counsel argued that J & J’s talcum powder contains not one, not two, but three carcinogens: talc, asbestos, and heavy metals. Talc, of course, is the focus of the claim and the trial, but what about the other two? Plaintiffs’ counsel did not advert to any evidence or opinion that heavy metals cause ovarian cancer; nor did he even slow down to say what heavy metals he was claiming were present. The evidence that asbestos causes ovarian cancer is perhaps marginally credible, but the causal conclusion is still doubtful. The studies that suggest an association are generally poorly done and heavily confounded. The real issue, however, with the asbestos claim, other than its effectiveness in instilling fear and knee-jerk reactions among lay jurors, is that it obscures an important issue whether the tremolite that sometimes accompanies talc in serpentine rock deposits is actually tremolite asbestos. Tremolite, as a mineral, has numerous crystallogaphic “habits,” including acicular fibers, angular particles, plates, etc.² Some time ago, the federal government adopted a convention of counting anything as a “fiber,” if it were greater than 5 μm in length, and it had an aspect ratio of at least three to one. Another agency, the U.S. EPA adopted a minimal 5:1 aspect ratio, but both federal regulatory definitions disregard both mineralogical and biological considerations for what is a “fiber” with biological effects. Pace Melanie³, a thing is not a phallic system if it is just longer than it is wide, and a tremolite cleavage fragment is not a fiber, even if it is three times longer than wide.

There were other notable rhetorical moves in Plaintiff’s opening statement. In most other litigations, Plaintiffs run away from the need to rule out random error in studies that their expert witnesses proffer as support for causal claims. See, e.g., In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, U.S. Court of Appeals, 3rd Circuit, No. 16-2247 (June 2, 2017). In doing so, Plaintiffs often distort the consensus views about statistical significance, from the American Statistical Association⁴ and other groups. In the Slemp case, however, Plaintiff’s counsel swung to an opposite extreme by over-endorsing statistical significance as the apparent end-all and be-all for assessing causality. Study validity, whether internal or external, received no serious mention; bias in the studies relied upon was not discussed in any meaningful way.

To highlight the disingenuousness of the Plaintiffs’ opening with respect to failing to consider study validity and bias, and its over-endorsement of statistical significance, the Plaintiff later in the trial flashed sound bites from a report, commissioned by J & J, on the claimed causal connection. The report was by done other than Professor Kenneth Rothman, along with others. Professor Rothman has been in the forefront of criticizing the use of statistical significance testing as a bright-line criterion for causation. Rothman, along with Jonathan Samet (hardly a defense friendly epidemiologist) and Harris Pastides, reported, in 2000, that there was a “statistically significant” association, but demurred on causation because of the problem of study bias and validity:

“A weighted average of the results from epidemiologic studies to date measuring the relation between talc and ovarian cancer risk gives an overall relative risk of 1.31, with a 95% confidence interval of 1.21-1.41. Bias and causation are competing explanations for the weak positive association observed. This weak association could be an underestimate of a stronger association if there are errors in measuring talc exposure that apply uniformly to all study subjects (non-differential misclassification). On the other hand, non-differential misclassification does not bias an association that is null to begin with, so postulating non-differential misclassification cannot shed light on whether the association results from a causal relation or not. Most of the published studies are interview-based case-control studies, subject to recall bias, which can readily give rise to associations of this magnitude. The evidence from these studies regarding recall bias is mixed. Uncontrolled confounding can also easily explain associations this weak; although no single confounding factor would seem to account for the overall effect, the combined effect of several such unidentified confounders could do so. In considering these competing explanations of bias and causation, the evidence in favor of a causal explanation is only the overall weak association of a relative risk of 1.31. The lack of a plausible biologic mechanism, on the other hand, weighs against a causal interpretation. Also weighing against a causal explanation is the dose-response pattern among talc users, which is an inverse trend for both duration of use and frequency of use. A causal relation would predict a positive trend, not an inverse trend. Based on these considerations, we suggest that the evidence to date does not indicate that talc can be ‘reasonably anticipated to be a human carcinogen’.”

Kenneth J. Rothman Harris Pastides Jonathan Samet, “Interpretation of Epidemiologic Studies on Talc and Ovarian Cancer,” (Nov. 28, 2000).

From a rhetorical perspective, one of the more interesting moves in Plaintiff’s opening was a pivot from causation to association. Without ever really discussing the standards or factors for inferring causation, Plaintiff’s counsel invoked regulatory standards and avoided addressing himself to the Missouri standard of causation. The standards for whether to warn and for determining cause in fact were conflated and confused, in what seemed liked a deliberate effort.

Defense Openings

J & J’s Opening

The defense strategies were apparent enough. The defense emphasized that Ms. Slemp had a serous borderline tumor (SBT). The emphasis appeared to be a plea of confession and avoidance. In other words, maybe there is something going on with talc and ovarian cancer, but this is an SBT, and it is different, so you do not need to worry too much about the more general claim that talc causes ovarian cancer. SBTs are a subset of epithelial ovarian tumors, often characterized as semi-malignant, with a more favorable outcome than other ovarian epithelial tumors. The defense also strived to shift the spotlight to Ms. Slemp and her strikingly poor health, preëxisting her cancer diagnosis, as well as her massive obesity and her heavy smoking, both risk factors for ovarian cancer.

On the positive side, J & J’s counsel anticipated and warned the jury that plaintiffs’ expert witnesses would be seriously challenged on their post-hoc analyses and their failing to share their causal conclusions with the scientific community. J & J’s counsel did engage on the general causation claim, but mostly to argue that most governmental agencies and professional organizations have refused to accept the causal claim. To the limited extent that J & J got into the “weeds,” it identified the Bradford Hill factors as the generally accepted decision procedure for reaching causal conclusions. So far, so good (except for the insistence upon referring to Sir Austin as Sir Bradford, as though Bradford was the man’s first name). What defense counsel did not say, astonishingly, is that Sir Austin’s nine factors require a necessary predicate that is satisfied when:

“Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance.”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965). See “Woodside & Davis on the Bradford Hill Considerations” (Aug. 23, 2013). To be sure, there are any number of studies on talc and ovarian cancer that satisfy Hill’s requirement of an association not attributable to the play of chance, but what is lacking is the clear-cut association; that is, the associations that are “statistically significant” have not ruled out bias and confounding. The defense opening did introduce the concept of recall bias, which plays an important part in undermining the validity of the available case-control studies. What the defense did not say, however, is that misclassification biases in cohort studies do not always bias towards the null, and even if they did, then the latest cohort study (with a hazard ratio below 1.0) would have had a risk ratio even lower than 1.0 than what was reported.

The defense did emphasize the absence of the Bradford Hill factors for plausibility and dose response. A more sophisticated analysis would have acknowledged what Sir Austin had over 60 years ago: plausibility or explanation is not necessary to infer causation. Not all the Bradford Hill factors are equal, and the defense diluted the analysis by falsely elevating one factor, plausibility, to the status of a necessary criterion.

The defense opening also had some dubious moves. It deprecated case-control studies as inferior to cohort studies, both as a general proposition and specifically with respect to talc. Case-control studies are generally harder to do, as the Plaintiffs’ bar learned when it based an entire mass tort litigation on a single case-control study, the so-called Yale Hemorrhagic Stroke Project.⁵ The Plaintiffs won the Daubert war⁶ in that litigation, but lost their jury trials because juries ultimately saw the methodological flaws that the MDL court disregarded. The general proposition that cohort studies are always superior to case-control studies, however, is doubtful. The defense did not need to stake out this claim, especially since it was not going to call an epidemiologist to testify.

Some of the claims that the defense committed to in its opening were as stunning as they were dubious. J & J’s counsel promised that he would show that talc has been proven safe. That claim is, however, beyond what the available science can show, especially with a plethora of statistically significant associations in case-control studies. J & J need only show that the plaintiffs’ claim has not been established, but it created an unnecessary burden of proving safety. The rhetorical value of the claim is obvious, but promising to show something that cannot be delivered seems like a recipe for disaster. $110 million is a disaster.

Then there was a defense claim that epidemiology cannot show that talc causes ovarian cancer. The claim was unclear as to whether epidemiology cannot establish general or specific causation, and vague as to whether the inability resulted from the weak, equivocal evidence in the instance of talc and ovarian cancer, or some deeper inability that stems from the nature of the evidence itself. Of course, given that there is an expected base rate of ovarian cancer in the general population, epidemiology will be required, even if it may not be sufficient. But if epidemiology alone is not sufficient, then what else is required? The defense never clarified its claim.

As for specific causation, the notion that epidemiology never informs individual patient predictions or causal assessments seems far fetched. If are dealing with a case of mesothelioma and occupational crocidolite exposure, with relative risks in the thousands, the attribution based upon the existence of a very high relative risk seems eminently reasonable. The same with maternal thalidomide use and an infant’s phocomelia, even though there is a baseline risk of phocomelia. Even in the case of a heavy smoker and lung cancer, with relative risks in the range of 20 to 40, inferring specific causation seems like a sound inference, especially in the absence of evidence that the risk is segregated in some subgroup of the population that suffers the outcome.

Imerys’s Opening

Counsel for Imerys also gave an opening statement, which started on common defense themes of the need to reserve judgment until all evidence is heard, and the need to consider context for statements. Imerys echoed the dubious claims that epidemiology can never inform inferences about individual patients, that epidemiology has determined that talc is safe, that cohort studies are always better than case-control studies, and that cohort studies are better because they have many thousand of women in them as opposed to “just a handful” in case-control studies.

Imerys, however, soon wandered into territory that affirmatively undermined J & J’s defense. First, it applauded itself for having warned of “possible causation,” which tended to concede the point to plaintiffs that there is a duty to warn of possibly caused outcomes. Second, Imerys appropriately urged its bulk supplier defense, which placed the spotlight on J & J’s alleged culpability.

The Imerys lawyer may have offended the Missouri jury by referring to talc as a mineral formed millions of years ago. A large percentage of Americans believe that the Earth was created less than 6,000 years ago. And yet, we still believe that allowing ordinary citizens to decide scientific issues is a good thing!

In its opening, Imerys also misstated the law to its own detriment. In discussing its obligations to warn, Imerys asserted that as a mining company it had to follow the rules established by OSHA. Actually, not. Mining companies are under the jurisdiction of the Mining Safety and Health Administration (MSHA), and OSHA Hazards Communication regulations did not apply to mining companies for the years involved in the Slemp case. See Memorandum from Patricia K. Clark, Director of OSHA Compliance Programs, to Regional Administrators re Hazard Communication and Mining Operations (Mar. 3, 1992).

1 See also Anthony Pratkanis & Elliot Aronson, Age of Propaganda: The Everyday Use and Abuse of Persuasion at 210 (2000) (“[A]ll other things being equal, the more frightened a person is by a communication, the more likely her or she is to take positive preventive action.”); H.L. Mencken, In Defence of Women § 13 “Women and the Emotions” (1923) (“The whole aim of practical politics is to keep the populace alarmed (and hence clamorous to be led to safety) by menacing it with an endless series of hobgoblins, most of them imaginary.”); Conor Boyack, Feardom: How Politicians Exploit Your Emotions and What You Can Do to Stop Them (2014).

2 John W. Anthony, Richard A. Bideaux, Kenneth W. Bladh, and Monte C. Nichols, The Handbook of Mineralogy, vol. II (1995).

3 Melanie Safka, “Psychotherapy” (“A thing is a phallic symbol if it’s longer than it’s wide”).

4 Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” The American Statistician, available online (Mar. 7, 2016), in-press at DOI:10.1080/00031305.2016.1154108, <http://dx.doi.org/10.1080/>.

5 Walter N. Kernan, Catherine M. Viscoli, et al., “Phenylpropanolamine and the Risk of Hemorrhagic Stroke,” 343 New Engl. J. Med. 1826 (2000).

6 See In re Phenylpropanolamine Prod. Liab. Litig., 289 F. 2d 1230 (2003).

Posted in Asbestos, Causation, Scientific Evidence | Comments Off on The Slemp Case, Part 2 – Openings

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.

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

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.

Posted in Causation, Expert Witnesses, Scientific Evidence | Comments Off on The Slemp Case, Part I – Jury Verdict for Plaintiff – 10 Initial Observations

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).

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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).

Posted in Asbestos, Causation, Expert Witnesses, Frye, Rule 702, Scientific Evidence | Comments Off on New York Rejects the Asbestos Substantial Factor Ruse (Juni Case)

Talc Litigation in Missouri – Show Me the Law and the Evidence

February 22nd, 2017

In New Jersey, where the courts are particularly plaintiff friendly but not beyond the persuasive force of evidence, lawsuit industry claims that talc causes ovarian cancer have not fared well. Last year, Judge Johnson, of Atlantic County, New Jersey, held that the plaintiffs’ causal claims failed to meet even the minimal New Jersey legal threshold of scientific validity.¹ Meanwhile, in Missouri, juries have been returning large verdicts for plaintiffs on their claims that their use of talc products caused their ovarian cancers.²

What gives? Why is the outcome of similar litigation so different in New Jersey from that in Missouri? One might mistakenly think that courts in Missouri would be skeptical of scientifically dubious claims. After all, Missouri is the “Show Me” state; right? Many people understand the state’s nickname to mean that Missourians are not gullible.³

The reality of the origins of the Missouri nickname may well be different. The most cited account reports that a congressman from Missouri, Willard Duncan Vandiver, used the phrase in an 1899 speech:

“I come from a state that raises corn and cotton and cockleburs and Democrats, and frothy eloquence neither convinces nor satisfies me. I am from Missouri. You have got to show me.”

Basically, according to Vandiver, Missourians are “show me” simple folks because they do not read or understand eloquent language. Vandiver might have thought that scientific language was beyond his neighbors’ ken as well. Of course, things have changed since 1899. Missouri is no longer a state populated by Democrats. In the 2016 general election, Donald Drumpf received 56.8% of the Missouri votes cast. Hilary Clinton received 38.1%.⁴ Inquiring minds will want to know whether “Show Me” connotes incredulity or illiteracy.

One relevant difference between Missouri and many other states, and all the federal courts, is that some courts in Missouri engage in a particularly edentulous form of judicial gatekeeping of expert witness opinion testimony. The talc claims that resulted in large verdicts in Missouri never got off the dime (or got a dime) in New Jersey because plaintiffs’ expert witnesses’ opinions were excluded from courtrooms in the Garden State.

The resulting trials in Missouri have showcased some curious, doubtful rhetoric from legal counsel for the lawsuit industry. In his closing argument in Giannecchini v. Johnson & Johnson, the plaintiff’s lawyer accused Johnson & Johnson of having “rigged” regulatory agencies to ignore the dangers of talc.⁵ The argument was apparently effective and it has been repeated in another Missouri trial, in Swann v. Johnson & Johnson⁶, now underway. The plaintiffs’ opening “statement” in Swann was marked by overwrought, hyperbolic rhetoric.⁷

And the first trial days in Swann were dedicated by plaintiff’s counsel to showing, not that talc actually causes ovarian cancer, but to showing that the defendants engaged in lobbying with respect to the carcinogenic classification of talc by regulatory agencies.⁸ According to the coverage in legal news media, the first testimony offered was offered to show that after the National Toxicology Program (NTP) nominated talc for inclusion in its list of potential carcinogens, industry trade groups, such as the Cosmetic, Toiletry and Fragrance Association, “shut down serious regulator concerns through intensive lobbying efforts.”⁹

This is a remarkable digression from the truth finding function of an American jury trial for several reasons. First, the “shutting down” of regulator concern was not, in the media reports, associated with any fraudulent misrepresentations of the scientific record. By casting the lobbying in an unflattering light, the plaintiff was able to undermine the truth value of agencies’ refusal to characterize talc as an ovarian carcinogen. The media coverage did not suggest that the lobbying involved the presentation of sham evidence or arguments that might have misled agencies about the correctness of their position.

Second, if the industry lobbying had badly misled the National Toxicology Program, or other government body, then there would no doubt be a conclusive case for causation today. The fact of the matter, however, is that there is no conclusive case for the claim that talc causes ovarian cancer. Late last year, the “Sister Study,” which explored whether there was any association between perineal talc use and ovarian cancer, was published in Epidemiology.¹⁰ The Sister Study (2003–2009) followed a cohort of 50,884 women whose sisters had been diagnosed with breast cancer. Talc use was ascertained at baseline, before diagnosis of subsequent disease and before any chance for selective recall. The cohort was followed for a median of 6.6 years, in which time there were 154 cases of ovarian cancer, available for analysis using Cox’s proportional hazards model. Perineal talc use at baseline was not associated with later ovarian cancer. The authors reported a hazard ratio of 0.73, less than expected, with a 95% confidence interval of 0.44, 1.2. Such a powerful study, showing the absence of any large or even modest association, would hardly be feasible if the science were so clear in the year 2000 that no reasonable scientist would have advocated against the NTP’s proposed classification.

Third, the lawsuit industry’s focus on lobbying activities in the Giannecchini and the Swann cases raises serious issues of infringing upon the defendants’ first amendment rights. The defendants’ advocacy for non-sham, non-fraudulent scientific positions is protected by the federal constitution, under what has come to be known as the Noerr-Pennington doctrine.

The Noerr-Pennington Doctrine of Immunity

One of the first agenda items for the first United States Congress was the drafting of a “Bill of Rights” to be submitted to the individual States for ratification. The First amendment (originally the third until the first two were dropped) sets forth a basic “right of the people to peaceably assemble, and to petition the government for a redress of grievances.”¹¹ In the context of lobbying legislatures and regulatory agencies, the Supreme Court has long regarded lobbying and advocacy for and against legislation and regulation as core political speech that is protected by the right to petition the government.¹²

Part of this constitutional guarantee is a freedom to associate with others to lobby for redress.¹³ The constitutional protection is not lost by an economic or self-interested motivation in the lobbying or advocacy.¹⁴This constitutional protection of advocacy positions results in an immunity from civil liability for speech, association, and conduct undertaken to advance advocacy positions before legislatures, agencies, and courts.¹⁵ This immunity, over half a century old, has come to be known as the Noerr-Pennington doctrine.

Although the original Noerr-Pennington doctrine cases specifically addressed claims of antitrust liability, later cases have held that the immunity applies with equal force in tort cases. State courts, regardless of their state constitutions, are of course obliged to grant and protect the federal Noerr-Pennington immunity.¹⁶

The unconstitutional infringement of defendants’ first amendment rights is hardly an innovation in Giannecchini and Swann cases. For decades, the lawsuit industry, which jealously guards its own first amendment rights, has overzealously pressed conspiracy and tort claims against manufacturing industry for trying to influence legislation and regulation. In Senart v. Mobay Chem. Corp., 597 F. Supp. 502 (D. Minn. 1984), plaintiffs alleged that they were harmed by exposure to toluene diisocyanate (TDI), a feedstock chemical used in making polyurethane foam. The plaintiffs sued TDI manufacturers, on conspiracy claims that the manufacturers had jointly influenced the Occupational and Safety Health Administration (OSHA) to reject a recommendation from the National Institute for Occupational Safety and Health (NIOSH) for lower permissible exposure standards for TDI. Senart, 597 F. Supp. at 504. The plaintiffs’ conspiracy complaint was based upon allegations that the manufacturing defendants “knew of a body of scientific evidence which suggested that workers could suffer harm at exposure levels below the prevailing … standard,” and and that they “conspired to ‘obfuscate and confuse’ scientific findings which supported a more stringent standard.” Id. Plaintiffs also alleged that the TDI manufacturers knew that a more stringent TDI exposure standard would harm their businesses. Id.

The trial court dismissed the conspiracy count in Senart. “[E]ven accepting plaintiffs’ allegations as true, defendants concerted action sought only permissible ends and acted through permissible means.” Id. at 505-6 (footnote omitted). The defendants work in concert through their trade association to persuade OSHA to reject the NIOSH proposal was clearly protected by the first amendment. Id. at 506 (internal citations omitted).

Following Senart, federal courts in later products cases have applied he Noerr-Pennington doctrine to bar tort claims. In a 1996 class action, a district court held that the immunity barred a class action filed by relatives of gunshot victims against gun manufacturers. Hamilton v. ACCU-TEK 935 F. Supp. 1307 (E.D.N.Y. 1996). The court, in Hamilton, found the plaintiffs’ negligence and product liability claims untenable:

“Defendants’ efforts to affect federal firearm policies through lobbying activities are prime examples of the types of activity the First Amendment, through its rights of free speech and petition, sought to protect… . A core principle of the Noerr-Pennington doctrine is that lobbying alone cannot form the basis of liability… .”

Id. at 1321. The court in Hamilton dismissed the product liability claims. See also Tuosto v. Philip Morris USA Inc., No. 05 Civ. 9384 (PKL), 2007 WL 2398507, at *5 (S.D.N.Y. Aug. 21, 2007) (noting that the immunity “applied to bar liability in state common law tort claims, including negligence and products liability claims, for statements made in the course of petitioning the government”).

The lawsuit industry is one of the largest rent-seeking groups in the United States. Our courts need to apply constitutional standards in a symmetrical fashion, with an understanding that what is spoken in the halls of legislatures and agencies is protected at least as much as speech in the courtroom, and that the constitutional rights of manufacturing industry should not be subordinated to the rights of the lawsuit industry. Maybe lawyers need to figure out how to “show” the constitution in pictograms, without all the 18^th century eloquence.

1 Carl v. Johnson & Johnson, No. ATL-L-6546-14, 2016 WL 4580145 (N.J. Super. Ct. Law Div., Atl. Cty., Sept. 2, 2016).See “New Jersey Kemps Ovarian Cancer – Talc Cases” (Sept. 16, 2016).

2 “Talc Litigation – Stop the Madness” (Nov. 10, 2016) (describing large verdict for plaintiff in Giannecchini v. Johnson & Johnson); see also Myron Levin, “Johnson & Johnson Hammered Again in Talc-Ovarian Cancer Verdict of $70 Million,” Law360 (Oct. 27, 2016); Brandon Lowrey, “J & J, Talc Co. Hit With $70M Baby Powder Cancer Verdict,” Law360 (Oct. 2016).

3 See “The Show-Me State,” last visited Feb. 21, 2017.

4 See “State of Missouri – 2016 General Election – November 8, 2016,” last visited Feb. 21, 2017. I leave it to the reader to assess whether the state nickname describes incredulity or illiteracy.

5 Myron Levin, “Johnson & Johnson Hammered Again in Talc-Ovarian Cancer Verdict of $70 Million,” Law360 (Oct. 27, 2016); Brandon Lowrey, “J & J, Talc Co. Hit With $70M Baby Powder Cancer Verdict,” Law360 (Oct. 2016).

6 Swann v. Johnson & Johnson, case number 1422-CC09326-01, in the 22nd Judicial Circuit of Missouri.

7 Cara Salvatore, “J&J Hid Talc Risk For ‘Love Of Money’, Jury Hears,” Law360 (Feb. 9, 2017).

8 Cara Salvatore, “Talc Lobbyists Stymied Carcinogen Classification, Jury Hears,” Law360 (Feb. 10, 2017).

9 Id.

10 Nicole L. Gonzalez, Katie M. O’Brien, Aimee A. D’Aloisio, Dale P. Sandler, and Clarice R. Weinberg, “Douching, Talc Use, and Risk of Ovarian Cancer,” 27 Epidemiology 797 (2016).

11 U.S. Const. amend. I.

12 California Motor Transp. Co. v. Trucking Unlimited, 404 U.S. 508, 510 (1972) (disallowing a cause of action “predicated upon mere attempts to influence the Legislative branch for the passage of laws or the Executive branch for their enforcement.”); United Mine Workers of Am. v. Ill. State Bar Ass’n, 389 U.S. 217, 222 (1967) (characterizing the right to petition as “among the most precious of the liberties safeguarded by the Bill of Rights”). United Mine Workers of Am. v. Pennington, 381 U.S. 657, 669-70 (1965); Doe v. McMillan, 566 F.2d 713, 718 (D.C.Cir. 1977), cert. denied, 435 U.S. 969 (1978) (holding that the first amendment constitutional right to petition the legislature “extends to administrative agencies and the courts”).

13 N.A.A.C.P. v. Button, 371 U.S. 415, 430 (1963) (protecting the right “to engage in association for the advancement of beliefs and ideas”); N.A.A.C.P. v. Alabama ex rel. Patterson, 357 U.S. 449, 460 (1958) (“[e]ffective advocacy of both public and private points of view, particularly controversial ones, is undeniably enhanced by group association … .”). The right of association to further lobbying activities has been described as having a “preferred place” along with other first amendment freedoms, such that the Court will not tolerate “dubious intrusions.” Thomas v. Collins, 323 U.S. 516, 530 (1945).

14 Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748, 762 (1976); Sawyer v. Sandstrom, 615 F.2d 311, 316 (5th Cir. 1980) (“The right to freely associate is not limited to those associations which are ‘political in the customary sense’, but includes those which ‘pertain to the social, legal, and economic benefit of the members’.”) (citing Griswold v. Connecticut, 381 U.S. 479, 483 (1965)); International Union v. National Right to Work Legal Defense & Education Foundation, Inc., 590 F.2d 1139, 1148 (D.C. Cir. 1978) (“Even economically motivated expression or association is not disqualified from protection under the first amendment.”); Greminger v. Seaborne, 584 F.2d 275, 278 (8th Cir. 1978) (observing that the constitutionally protected “[f]reedom of association includes membership in unions or other organizations concerned with ‘business and economic causes’.”); Senart v. Mobay Chem. Corp., 597 F. Supp. 502, 506 (D.Minn. 1984) (“Selfish motivations do not lessen one’s right to present views to the government.”).

15 Eastern Railroad Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127 (1961); United Mine Workers v. Pennington, 381 U.S. 657 (1965).

16 Fraser v. Bovino, 317 N.J. Super 23, 37 (App. Div. 1998) (recognizing “the fundamental values that undergird a citizen’s right to communicate on issues of public import”); Village Supermarket, Inc. v. Mayfair, 269 N.J. Super. 224, 229-32 (Law Div. 1995) (refusing to interpret New Jersey tort law to permit claims based on lobbying activity protected by the First Amendment); ARTS4ALL Ltd. v. Hancock, 810 N.Y.S.2d 15, 16 (App. Div. 2006) (denying employee’s motion for summary judgment on claim for breach of no-disparagement clause in severance agreement, holding that employer’s statements to government officials were protected by Noerr-Pennington doctrine); Concourse Nursing Home v. Engelstein, 692 N.Y.S. 2d 888, 891 (Sup. Ct. 1999) (holding law firm was immune from business tort claims for successful lobbying efforts); I.G. Second Generation Partners v. Reade, 793 N.Y.S.2d 379, 381 (App. Div. 2005) (holding that Noerr–Pennington immunity barred claim for tortious interference); Diaz v. Southwest Wheel, 736 S.W.2d 770, 771 (Tx. Ct. App. 1987) (holding that Noerr-Pennington immunity barred conspiracy claims against tire manufacturer, which as a member of a trade association, opposed the recall on defective tire rims and restrictions on multi-piece wheels).

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