TORTINI

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

N.J. Supreme Court Uproots Weeds in Garden State’s Law of Expert Witnesses

August 8th, 2018

The United States Supreme Court’s decision in Daubert is now over 25 years old. The idea of judicial gatekeeping of expert witness opinion testimony is even older in New Jersey state courts. The New Jersey Supreme Court articulated a reliability standard before the Daubert case was even argued in Washington, D.C. See Landrigan v. Celotex Corp., 127 N.J. 404, 414 (1992); Rubanick v. Witco Chem. Corp., 125 N.J. 421, 447 (1991). Articulating a standard, however, is something very different from following a standard, and in many New Jersey trial courts, until very recently, the standard was pretty much anything goes.

One counter-example to the general rule of dog-eat-dog in New Jersey was Judge Nelson Johnson’s careful review and analysis of the proffered causation opinions in cases in which plaintiffs claimed that their use of the anti-acne medication isotretinoin (Accutane) caused Crohn’s disease. Judge Johnson, who sits in the Law Division of the New Jersey Superior Court for Atlantic County held a lengthy hearing, and reviewed the expert witnesses’ reliance materials.1 Judge Johnson found that the plaintiffs’ expert witnesses had employed undue selectivity in choosing what to rely upon. Perhaps even more concerning, Judge Johnson found that these witnesses had refused to rely upon reasonably well-conducted epidemiologic studies, while embracing unpublished, incomplete, and poorly conducted studies and anecdotal evidence. In re Accutane, No. 271(MCL), 2015 WL 753674, 2015 BL 59277 (N.J.Super. Law Div., Atlantic Cty. Feb. 20, 2015). In response, Judge Johnson politely but firmly closed the gate to conclusion-driven duplicitous expert witness causation opinions in over 2,000 personal injury cases. “Johnson of Accutane – Keeping the Gate in the Garden State” (Mar. 28, 2015).

Aside from resolving over 2,000 pending cases, Judge Johnson’s judgment was of intense interest to all who are involved in pharmaceutical and other products liability litigation. Judge Johnson had conducted a pretrial hearing, sometimes called a Kemp hearing in New Jersey, after the New Jersey Supreme Court’s opinion in Kemp v. The State of New Jersey, 174 N.J. 412 (2002). At the hearing and in his opinion that excluded plaintiffs’ expert witnesses’ causation opinions, Judge Johnson demonstrated a remarkable aptitude for analyzing data and inferences in the gatekeeping process.

When the courtroom din quieted, the trial court ruled that the proffered testimony of Dr., Arthur Kornbluth and Dr. David Madigan did not meet the liberal New Jersey test for admissibility. In re Accutane, No. 271(MCL), 2015 WL 753674, 2015 BL 59277 (N.J.Super. Law Div. Atlantic Cty. Feb. 20, 2015). And in closing the gate, Judge Johnson protected the judicial process from several bogus and misleading “lines of evidence,” which have become standard ploys to mislead juries in courthouses where the gatekeepers are asleep. Recognizing that not all evidence is on the same analytical plane, Judge Johnson gave case reports short shrift.

[u]nsystematic clinical observations or case reports and adverse event reports are at the bottom of the evidence hierarchy.”

Id. at *16. Adverse event reports, largely driven by the very litigation in his courtroom, received little credit and were labeled as “not evidentiary in a court of law.” Id. at 14 (quoting FDA’s description of FAERS).

Judge Johnson recognized that there was a wide range of identified “risk factors” for irritable bowel syndrome, such as prior appendectomy, breast-feeding as an infant, stress, Vitamin D deficiency, tobacco or alcohol use, refined sugars, dietary animal fat, fast food. In re Accutane, 2015 WL 753674, at *9. The court also noted that there were four medications generally acknowledged to be potential risk factors for inflammatory bowel disease: aspirin, nonsteroidal anti-inflammatory medications (NSAIDs), oral contraceptives, and antibiotics. Understandably, Judge Johnson was concerned that the plaintiffs’ expert witnesses preferred studies unadjusted for potential confounding co-variables and studies that had involved “cherry picking the subjects.” Id. at *18.

Judge Johnson had found that both sides in the isotretinoin cases conceded the relative unimportance of animal studies, but the plaintiffs’ expert witnesses nonetheless invoked the animal studies in the face of the artificial absence of epidemiologic studies that had been created by their cherry-picking strategies. Id.

Plaintiffs’ expert witnesses had reprised a common claimants’ strategy; namely, they claimed that all the epidemiology studies lacked statistical power. Their arguments often ignored that statistical power calculations depend upon statistical significance, a concept to which many plaintiffs’ counsel have virulent antibodies, as well as an arbitrarily selected alternative hypothesis of association size. Furthermore, the plaintiffs’ arguments ignored the actual point estimates, most of which were favorable to the defense, and the observed confidence intervals, most of which were reasonably narrow.

The defense responded to the bogus statistical arguments by presenting an extremely capable clinical and statistical expert witness, Dr. Stephen Goodman, to present a meta-analysis of the available epidemiologic evidence.

Meta-analysis has become an important facet of pharmaceutical and other products liability litigation[1]. Fortunately for Judge Johnson, he had before him an extremely capable expert witness, Dr. Stephen Goodman, to explain meta-analysis generally, and two meta-analyses he had performed on isotretinoin and irritable bowel outcomes.

Dr. Goodman explained that the plaintiffs’ witnesses’ failure to perform a meta-analysis was telling when meta-analysis can obviate the plaintiffs’ hyperbolic statistical complaints:

the strength of the meta-analysis is that no one feature, no one study, is determinant. You don’t throw out evidence except when you absolutely have to.”

In re Accutane, 2015 WL 753674, at *8.

Judge Johnson’s judicial handiwork received non-deferential appellate review from a three-judge panel of the Appellate Division, which reversed the exclusion of Kornbluth and Madigan. In re Accutane Litig., 451 N.J. Super. 153, 165 A.3d 832 (App. Div. 2017). The New Jersey Supreme Court granted the isotretinoin defendants’ petition for appellate review, and the issues were joined over the appropriate standard of appellate review for expert witness opinion exclusions, and the appropriateness of Judge Johnson’s exclusions of Kornbluth and Madigan. A bevy of amici curiae joined in the fray.2

Last week, the New Jersey Supreme Court issued a unanimous opinion, which reversed the Appellate Division’s holding that Judge Johnson had “mistakenly exercised” discretion. Applying its own precedents from Rubanick, Landrigan, and Kemp, and the established abuse-of-discretion standard, the Court concluded that the trial court’s ruling to exclude Kornbluth and Madigan was “unassailable.” In re Accutane Litig., ___ N.J. ___, 2018 WL 3636867 (2018), Slip op. at 79.3

The high court graciously acknowledged that defendants and amici had “good reason” to seek clarification of New Jersey law. Slip op. at 67. In abandoning abuse-of-discretion as its standard of review, the Appellate Division had relied upon a criminal case that involved the application of the Frye standard, which is applied as a matter of law. Id. at 70-71. The high court also appeared to welcome the opportunity to grant review and reverse the intermediate court reinforce “the rigor expected of the trial court” in its gatekeeping role. Id. at 67. The Supreme Court, however, did not articulate a new standard; rather it demonstrated at length that Judge Johnson had appropriately applied the legal standards that had been previously announced in New Jersey Supreme Court cases.4

In attempting to defend the Appellate Division’s decision, plaintiffs sought to characterize New Jersey law as somehow different from, and more “liberal” than, the United States Supreme Court’s decision in Daubert. The New Jersey Supreme Court acknowledged that it had never formally adopted the dicta from Daubert about factors that could be considered in gatekeeping, slip op. at 10, but the Court went on to note what disinterested observers had long understood, that the so-called Daubert factors simply flowed from a requirement of sound methodology, and that there was “little distinction” and “not much light” between the Landrigan and Rubanick principles and the Daubert case or its progeny. Id at 10, 80.

Curiously, the New Jersey Supreme Court announced that the Daubert factors should be incorporated into the New Jersey Rules 702 and 703 and their case law, but it stopped short of declaring New Jersey a “Daubert” jurisdiction. Slip op. at 82. In part, the Court’s hesitance followed from New Jersey’s bifurcation of expert witness standards for civil and criminal cases, with the Frye standard still controlling in the criminal docket. At another level, it makes no sense to describe any jurisdiction as a “Daubert” state because the relevant aspects of the Daubert decision were dicta, and the Daubert decision and its progeny were superseded by the revision of the controlling statute in 2000.5

There were other remarkable aspects of the Supreme Court’s Accutane decision. For instance, the Court put its weight behind the common-sense and accurate interpretation of Sir Austin Bradford Hill’s famous articulation of factors for causal judgment, which requires that sampling error, bias, and confounding be eliminated before assessing whether the observed association is strong, consistent, plausible, and the like. Slip op. at 20 (citing the Reference Manual at 597-99), 78.

The Supreme Court relied extensively on the National Academies’ Reference Manual on Scientific Evidence.6 That reliance is certainly preferable to judicial speculations and fabulations of scientific method. The reliance is also positive, considering that the Court did not look only at the problematic epidemiology chapter, but adverted also to the chapters on statistical evidence and on clinical medicine.

The Supreme Court recognized that the Appellate Division had essentially sanctioned an anything goes abandonment of gatekeeping, an approach that has been all-too-common in some of New Jersey’s lower courts. Contrary to the previously prevailing New Jersey zeitgeist, the Court instructed that gatekeeping must be “rigorous” to “prevent[] the jury’s exposure to unsound science through the compelling voice of an expert.” Slip op. at 68-9.

Not all evidence is equal. “[C]ase reports are at the bottom of the evidence hierarchy.” Slip op. at 73. Extrapolation from non-human animal studies is fraught with external validity problems, and such studies “far less probative in the face of a substantial body of epidemiologic evidence.” Id. at 74 (internal quotations omitted).

Perhaps most chilling for the lawsuit industry will be the Supreme Court’s strident denunciation of expert witnesses’ selectivity in choosing lesser evidence in the face of a large body of epidemiologic evidence, id. at 77, and their unprincipled cherry picking among the extant epidemiologic publications. Like the trial court, the Supreme Court found that the plaintiffs’ expert witnesses’ inconsistent use of methodological criteria and their selective reliance upon studies (disregarding eight of the nine epidemiologic studies) that favored their task masters was the antithesis of sound methodology. Id. at 73, citing with approval, In re Lipitor, ___ F.3d ___ (4th Cir. 2018) (slip op. at 16) (“Result-driven analysis, or cherry-picking, undermines principles of the scientific method and is a quintessential example of applying methodologies (valid or otherwise) in an unreliable fashion.”).

An essential feature of the Supreme Court’s decision is that it was not willing to engage in the common reductionism that has “all epidemiologic studies are flawed,” and which thus privileges cherry picking. Not all disagreements between expert witnesses can be framed as differences in interpretation. In re Accutane will likely stand as a bulwark against flawed expert witness opinion testimony in the Garden State for a long time.


1 Judge Nelson Johnson is also the author of Boardwalk Empire: The Birth, High Times, and Corruption of Atlantic City (2010), a spell-binding historical novel about political and personal corruption.

2 In support of the defendants’ positions, amicus briefs were filed by the New Jersey Business & Industry Association, Commerce and Industry Association of New Jersey, and New Jersey Chamber of Commerce; by law professors Kenneth S. Broun, Daniel J. Capra, Joanne A. Epps, David L. Faigman, Laird Kirkpatrick, Michael M. Martin, Liesa Richter, and Stephen A. Saltzburg; by medical associations the American Medical Association, Medical Society of New Jersey, American Academy of Dermatology, Society for Investigative Dermatology, American Acne and Rosacea Society, and Dermatological Society of New Jersey, by the Defense Research Institute; by the Pharmaceutical Research and Manufacturers of America; and by New Jersey Civil Justice Institute. In support of the plaintiffs’ position and the intermediate appellate court’s determination, amicus briefs were filed by political action committee the New Jersey Association for Justice; by the Ironbound Community Corporation; and by plaintiffs’ lawyer Allan Kanner.

3 Nothing in the intervening scientific record called question upon Judge Johnson’s trial court judgment. See, e.g., I.A. Vallerand, R.T. Lewinson, M.S. Farris, C.D. Sibley, M.L. Ramien, A.G.M. Bulloch, and S.B. Patten, “Efficacy and adverse events of oral isotretinoin for acne: a systematic review,” 178 Brit. J. Dermatol. 76 (2018).

4 Slip op. at 9, 14-15, citing Landrigan v. Celotex Corp., 127 N.J. 404, 414 (1992); Rubanick v. Witco Chem. Corp., 125 N.J. 421, 447 (1991) (“We initially took that step to allow the parties in toxic tort civil matters to present novel scientific evidence of causation if, after the trial court engages in rigorous gatekeeping when reviewing for reliability, the proponent persuades the court of the soundness of the expert’s reasoning.”).

5 The Court did acknowledge that Federal Rule of Evidence 702 had been amended in 2000, to reflect the Supreme Court’s decision in Daubert, Joiner, and Kumho Tire, but the Court did not deal with the inconsistencies between the present rule and the 1993 Daubert case. Slip op. at 64, citing Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 320-21, 320 n.8 (3d Cir. 2003).

6 See Accutane slip op. at 12-18, 24, 73-74, 77-78. With respect to meta-analysis, the Reference Manual’s epidemiology chapter is still stuck in the 1980s and the prevalent resistance to poorly conducted, often meaningless meta-analyses. SeeThe Treatment of Meta-Analysis in the Third Edition of the Reference Manual on Scientific Evidence” (Nov. 14, 2011) (The Reference Manual fails to come to grips with the prevalence and importance of meta-analysis in litigation, and fails to provide meaningful guidance to trial judges).

P-Values: Pernicious or Perspicacious?

May 12th, 2018

Professor Kingsley R. Browne, of the Wayne State University Law School, recently published a paper that criticized the use of p-values and significance testing in discrimination litigation. Kingsley R. Browne, “Pernicious P-Values: Statistical Proof of Not Very Much,” 42 Univ. Dayton L. Rev. 113 (2017) (cited below as Browne). Browne amply documents the obvious and undeniable, that judges, lawyers, and even some ill-trained expert witnesses, are congenitally unable to describe and interpret p-values properly. Most of Browne’s examples are from the world of anti-discrimination law, but he also cites a few from health effects litigation as well. Browne also cites from many of the criticisms of p-values in the psychology and other social science literature.

Browne’s efforts to correct judicial innumeracy are welcomed, but they take a peculiar turn in this law review article. From the well-known state of affairs of widespread judicial refusal or inability to discuss statistical concepts accurately, Browne argues for what seem to be two incongruous, inconsistent responses. Rejecting the glib suggestion of former Judge Posner that evidence law is not “fussy” about evidence, Browne argues that federal evidence law requires courts to be “fussy” about evidence, and that Rule 702 requires courts to exclude expert witnesses, whose opinions fail to “employ[] in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Browne at 143 (quoting from Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). Browne tells us, with apparently appropriate intellectual rigor, that “[i]f a disparity that does not provide a p-value of less than 0.05 would not be accepted as meaningful in the expert’s discipline, it is not clear that the expert should be allowed to testify – on the basis of his expertise in that discipline – that the disparity is, in fact, meaningful.” Id.

In a volte face, Browne then argues that p-values do “not tell us much,” basically because they are dependent upon sample size. Browne suggests that the quantitative disparity between expected value and observed proportion or average can be assessed without the use of p-values, and that measuring a p-value “adds virtually nothing and just muddies the water.” Id. at 152. The prevalent confusion among judges and lawyers seems sufficient in Browne’s view to justify his proposal, as well as his further suggestion that Rule 403 should be invoked to exclude p-values:

The ease with which reported p-values cause a trier of fact to slip into the transposition fallacy and the difficulty of avoiding that lapse of logic, coupled with the relatively sparse information actually provided by the p-value, make p-values prime candidates for exclusion under Federal Rule of Evidence 403. *** If judges, not to mention the statistical experts they rely on, cannot use the information without falling into fallacious reasoning, the likelihood that the jury will misunderstand the evidence is very high. Since the p-value actually provides little useful relevant information, the high risk of misleading the jury greatly exceeds its scant probative value, so it simply should not be presented to the jury.”

Id. at 152-53.

And yet, elsewhere in the same article, Browne ridicules one court and several expert witnesses who have argued in favor of conclusions that were based upon p-values up to 50%.1 The concept of p-values cannot be so flexible as to straddle the extremes of having no probative value, and yet capable of rendering an expert witness’s opinions ludicrous. P-values quantify an estimate of random error, even if that error rate varies with sample size. To be sure, the measure of random error depends upon the specified model and assumption of a null hypothesis, but the crucial point is that the estimate (whether mean, proportion, risk ratio, risk difference, etc.) is rather meaningless without some further estimate of random variability of the estimate. Of course, random error is not the only type of error, but the existence of other potential systematic errors is hardly a reason to ignore random error.

In the science of health effects, many applications of p-values have given way to the use of confidence intervals, which arguably provide more direct assessments of both sample estimates, along with ranges of potential outcomes that are reasonably compatible with the sample estimates. Remarkably, Browne never substantively discusses confidence intervals in his article.

Under the heading of other problems with p-values and significance testing, Browne advances four additional putative problems with p-values. First, Browne asserts with little to no support that “[t]he null hypothesis is unlikely a priori.” Id. at 155. He fails to tell us why the null hypothesis of no disparity is not a reasonable starting place in the absence of objective evidence of a prior estimate. Furthermore, a null hypothesis of no difference will have legal significance in claims of health effects, or of unlawful discrimination.

Second, Browne argues that significance testing will lead to “[c]onflation of statistical and practical (or legal) significance” in the minds of judges and jurors. Id. at 156-58. This charge is difficult to sustain. The actors in legal cases can probably best appreciate practical significance and its separation from statistical significance, most readily. If a large class action showed that the expected value of a minority’s proportion was 15%, and the observed proportion was 14.8%, p < 0.05, most innumerate judges and jurors would sense that this disparity was unimportant and that no employer would fine tune its discriminatory activities so closely as to achieve such a meaningless difference.

Third, Browne reminds us that the validity and the interpretation of a p-value turns on the assumption that the statistical model is perfectly specified. Id. at 158-59. His reminder is correct, but again, this aspect of p-values (or confidence intervals) is relatively easy to explain, as well as to defend or challenge. To be sure, there may be legitimate disputes about whether an appropriate model was used (say binomial versus hypergeometric), but such disputes are hardly the most arcane issues that judges and jurors will face.

Fourth, Browne claims that “the alternative hypothesis is seldom properly specified.” Id. at 159-62. Unless analysts are focused on measuring pre-test power or type II error, however, they need not advance an alternative hypothesis. Furthermore, it is hardly a flaw with significance testing that it does not account for systematic bias or confounding.

Browne does not offer an affirmative response such as urging courts to adopt a Bayesian program. A Bayesian response to prevalent blunders in interpreting statistical significance would introduce perhaps even more arcane and hard-to-discern blunders in court proceedings. Browne also leaves courts without a meaningful approach to evaluate random error other than to engage in crude comparisons between two means or proportions. The recommendations in this law review article appear to be a giant step, backwards, into an epistemic void.


1See Browne at 146, citing In re Photochromic Lens Antitrust Litig., 2014 WL 1338605 (M.D. Fla. April 3, 2014) (reversing magistrate judge’s exclusion of an expert witness who had advanced claims based upon p-value of 0.50); id. at 147 n. 116, citing In re High-Tech Employee Antitrust Litig., 2014 WL 1351040 (N.D. Cal. 2014).

Johnson & Johnson Leaves Them in the Dust – Echeverria Verdict Unraveled

October 24th, 2017

It was a tough week for the talc litigation industry. On October 17, the Missouri Court of Appeals reversed a large verdict for plaintiffs because a St. Louis trial court unconstitutionally had asserted personal jurisdiction over Johnson & Johnson. In essence, the Missouri appellate court just said no to forum shopping. Fox v. Johnson & Johnson, Mo. Ct. App., No. ED104580 (Oct. 17, 2017). And on Friday, October 20, a California trial court, on sober second thought, granted judgment notwithstanding the verdict, and in the alternative, a new trial in the recent Escheverria case, which had resulted in plaintiffs’ awards approaching half a billion dollars. See Orders regarding Defendants Combined Motion for New Trial and Judgment Notwithstanding the Verdict, Echeverria v. Johnson & Johnson, Inc., Case No. BC628228, JCCP No. 4872, Calif. Super. Ct., Los Angeles Cty. (Oct. 20, 2017) [cited below as Echeverria op.] See also Daniel Siegal, “J&J Wins Battle Against $417M Talc Award, But War Not Over,” Law360 (Oct. 23, 2017).

The trial court issued an opinion, over 50 pages long, which carefully reviewed the parties’ contentions. Only some of the issues considered by the trial court are discussed below.

Differential Etiology

Differential etiology resembles the biological process of solid waste management; both employ the process of elimination.

Most diseases in humans have a large “idiopathic” or “cause unknown” component. The differential methodology purports to take all the known causes and rule out the ones that are improbable in a given case. As a matter of logic, this is what is known as an iterative disjunctive syllogism. If you start with:

A or B or C.

And you show not B;

and then, not C.

you are left with A.

This argument is, of course, a perfectly valid syllogism. If the premises are true, then the conclusion must be true. The problem is that the initial premise, to be accurate for many if not most human chronic diseases, must include a disjunct, U, or “cause unknown.” And once U is added to the first line of the syllogism, rarely is there a way to exclude it.

Sometimes the “cause unknown” component may be very small. For instance, in human malignant mesothelioma, the overwhelming majority of occupational cases do have a known cause: amphibole asbestos. When sufficient amphibole asbestos fiber exposure has been shown, there is usually no serious issue of individual attribution left for debate. The base rate of (idiopathic) mesothelioma is very low, and the relative risk from occupational amphibole asbestos exposure is extraordinarily large.

Ovarian cancer, which is the subject of the Escheverria case, is a very different story. The rate of idiopathic cases – no known causes – is much higher, and may even make up a majority of cases. The so-called differential etiology method never gets down to a conclusion that it is the talc (assuming arguendo that talc causes ovarian cancer). You always have talc or unknown cause in the conclusion.

In Escheverria, the plaintiffs’ lawyers called only one expert witness on specific causation, Echeverria’s treating physician, Dr. Annie Yessaian (“Yessaian”). Yessaian advanced a “differential etiology” analysis, which she claimed allowed her to conclude that talc was “more probable than not” a cause of plaintiff’s ovarian cancer. Echeverria op. at 5. Upon careful review, the trial court realized that Yessaian had never properly applied the iterative disjunctive syllogism, or differential etiology, to reach a valid conclusion. Despite a good deal of hand waving, Yessaian never ruled out other causes of the plaintiff’s ovarian cancer. Echeverria op. at 30.

The plaintiff’s menarche was at age 11, and so she had had a large number of ovulatory cycles. She was obese, and over 60 years old at the time of diagnosis. Yessaian did not rule these factors out; rather she testified without foundation that these factors were “less likely than not” causes of plaintiff’s ovarian cancer1. Echeverria op. at 31. The trial court noted that these potential causes had never been eliminated from the list of differentials; Yessaian had simply “discounted” them by ipse dixit. As for the “U,” or unknown causes that are clearly at play in many if not most ovarian cancers, Yessaian admitted that Escheverria’s cancer “probably” resulted from some unknown risk factor; but then, out of thin air, she testified that the probability of idiopathic causation was less than 50%. The trial court concluded that Yessian’s ruling in and ruling out decisions were ultimately nothing more than conjecture, and the plaintiff had never properly shown specific causation. Id. at 26-27, 31.

Relative Risk Less than Two

Yessaian’s specific causation opinion cratered further as a result of her inability to identify any specific biomarker or “fingerprint” of causation. The plaintiffs’ expert witnesses had argued that chronic inflammation is the mechanism by which talc causes ovarian cancer, but there was no histopathologic evidence of inflammation in association with ovarian tissue that had given rise to the cancer.

The relative risk argument is one way to attribute specific causation, and circumvent idiopathic causes by quantifying the contribution of the specific causal factor (again assuming it really is such) vis-a-vis the baseline risk of disease from unknown causes. The plaintiff, however, had called an expert witness on epidemiology, Jack Siemiatycki, who had explained that a risk ratio of 2.0 is “the point at which the probability of causation, which is the probability that a given agent causes a specific disease, exceeds 50 percent ….” Escheverria op. at 5. The defense epidemiologic expert, Dr. Douglas Weed, similarly testified and elaborated on the concept of probability of causation and attributable risk.2

The plaintiffs’ counsel attempted to extricate themselves from this arithmetic quagmire by arguing that there was “multiple causation,” and interaction among causes. Escheverria op. at 41-42. Yessaian, however, had disavowed even the most obvious concurrent causes (ovulatory cycles and age), and put all her markers down on talc. There was no evidence of multiple causation to muck up the analysis. Of course, the talc epidemiologic studies were all multivariate analyses that measured associations of talc and ovarian cancer in the presence of co-variates, such as age at menarche, and age at diagnosis.

Furthermore, Yessian was constrained by her acknowledgement that histologic type of ovarian cancer is highly relevant, and that none of the studies of serous ovaran cancer (the type diagnosed in Ms. Escheverria) reported out risk ratios in excess of 2.0. Escheverria op. at 28-29. Yessaian could not escape the inexorable math, and testimony about probability of causation from Jack Siemiatycki. Id at 29.3

Their case in extremis, the plaintiffs’ counsel argued4 that epidemiologic studies were not needed to prove causation, which might be true in a case involving a known mechanism with highly specific biomarkers to identify the causal mechanism that had taken place in the claimant. Having cited and relied extensively upon epidemiologic studies, Yessaian was hoisted with own her petard; the trial court found the assertion that there was an alternative path to specific causation to be absent from the record and quite incredible.

State of the Art

The duty to warn is constrained by what is known or should have been known at the time of marketing, what lawyers sometimes call “state of the art.” The trial court reasoned that since Eva Echeverria developed her serous ovarian cancer in 2007, the relevant scientific state of knowledge was censored at the time of plaintiff’s diagnosis. Any warning given after 2007 could not have prevented plaintiffs’ disease. (In truth, the relevant censoring date was likely well before 2007, but an earlier date would not have made a difference in the judicial outcome.)

There was no serious claim that the defendants had “secret” knowledge other than what was known in the scientific community. Plaintiffs’ expert witness on epidemiology, Jack Siemiatycki, co-chaired the IARC working group that concluded and published in 2007, that talc was a possible cause of ovarian cancer, a finding that rejected a higher classification, such as “probable” or “known.” IARC Monograph for Carbon Black, Titanium Dioxide & Talc, vol 93 (2010); Robert Baan, et al., “Carcinogenicity of carbon black, titanium dioxide, and talc,” 7 Lancet Oncology 295 (2006)5. In Escheverria, Siemiatycki testified in accordance with his public scientific work, and his service on the IARC working group, and he conceded that in 2007, there was no known causal connection between talc and human ovarian cancer. Notably, the defense lawyers failed to convert this state-of-the-art issue into a dispositive judgment because they had failed to ask for a binding jury instruction on the issue. Escheverria op. at 32.

For the trial court, the absence of scientific knowledge up to and including 2007, the year of Escheverria’s diagnosis, was also relevant to the existence vel non of malice that would support the imposition of punitive damages. Looking at the evidence in the light most favorable to the plaintiff, the trial court found that there was a scientific debate whether talc causes ovarian cancer, which debate would not allow the imputation of scienter to the defendants to permit the jury to infer that the defendants had acted with malice. Escheverria op. at 35. Given that no one in the medical or scientific community had asserted a relevant causal conclusion in or before 2007, the trial court’s conclusion is unassailable. The court’s analysis, however, begs the question why a lay jury is permitted to find any breach of a duty to warn, in the face of an engaged scientific community that uniformly refused to advance a causal conclusion in the relevant time frame.

New Trial on General and Specific Causation

The trial court did not belabor the analysis of general causation beyond pointing out that there were substantial uncertainties for many of the Bradford Hill considerations, such as consistency, strength, and exposure-response. With respect to specific causation, all the problems discussed on the motion for judgment notwithstanding the verdict were also relevant to finding that the plaintiff failed to establish specific causation by a preponderance of the evidence. Escheverria op. at 40.

The trial court identified several grounds for the grant of a new trial, but one ground involved improper argument by plaintiffs’ counsel, who has repeatedly resorted to the same argument in previous cases. Forewarned, the defense sought a ruling in limine to exclude all evidence of lobbying and communications with federal agencies over regulations and regulatory classifications of talc. In a pretrial ruling, the trial court permitted the use of company documents about attempts to influence the National Toxicology Program (NTP) and the IARC for the limited purpose of notice to defendants that scientific organizations were considering whether to label talc as a carcinogen. Escheverria op. at 45.

Perhaps the trial court was being charitable in assessing what the lobbying evidence would be used for, but the plaintiffs did not need evidence of lobbying to prove “notice.” Early, often, and deliberately, the plaintiffs’ lawyers used evidence of lobbying for purposes well beyond the permissible, limited relevancy of notice. Escheverria’s counsel, Allen Smith argued, in opening and in closing that the defendants had “fended off” the National Toxicology Program (NTP), and that “if Johnson & Johnson would have just stayed out of it, let the scientists do their work at the U.S. government, the NTP would have listed talc as a carcinogen as far back as 2000.” So lobbying activities were not used as evidence of notice at all, but rather for arguing an inference of malice and outrageous misconduct from the prevention of regulation. Escheverria op. at 46.

Predictable.


1 Yessaian did advert to a study that she interpreted as failing to establish an association between obesity and ovarian cancer, but for the other risk factors of age and ovulatory cycles, the plaintiff’s expert witness offered no basis at all.

2 The trial court studiously avoided reference to the defense expert witness on epidemiology. SeeEcheverria Talc Trial – Crossexamination on Alleged Expert Witness Misconduct” (Oct. 21, 2017).

3 citing well-known relative risk of two cases, Daubert v. Merrell Dow Pharms., Inc., 43 F. 3d 1311, 1321 (9th Cir. 1995); In re Lipitor (Atorvastatin Calcium) Mktg., Sales Prac. & Prod. Liab. Litig., 185 F. Supp. 3d 786, 791-92; Marder v. G.D. Searle & Co., 630 F. Supp. 1087, 1092 (D.Md. 1986), aff’d mem. on other grounds sub nom. Wheelahan v. G.D.Searle & Co., 814 F.2d 655 (4th Cir. 1987) (per curiam).

4 citing the dubious In re Neurontin Marketing, Sales Practices & Prods. Liab. Litig., 612 F. Supp. 2d 116, 132 (D. Mass. 2009), aff’d, 712 F.3d 21 (1st Cir. 2013).

5 Unfortunately, even the IARC classification of “probably” carcinogenic to humans is actually fairly meaningless exercises in semantics, not science. A close reading of the IARC Preamble definition of probable reveals that probable does not mean greater than 50%: “The terms probably carcinogenic and possibly carcinogenic have no quantitative significance and are used simply as descriptors of different levels of evidence of human carcinogenicity, with probably carcinogenic signifying a higher level of evidence than possibly carcinogenic.”

Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety

January 11th, 2017

Science necessarily involves a willingness to follow evidence to whatever conclusions are warranted, if conclusions properly can be had. When it comes to vaccination conspiracies, Democrats have it in their political DNA to distrust pharmaceutical companies that research, develop, and manufacture vaccines. The current Republican party, which has been commandeered by theocrats and populists, see vaccination as federal government aggrandizement, and resist vaccination policy as contrary to God’s will. Science is often the loser in the cross-fire.

And so we now have the public spectacle of watching the left and the right join in similar scientific apostasies. Consider how both McCain and Obama both suggested that vaccines and autism were related in the 2008 election. (Although both candidates were to some extent slippery in their suggestions, which might have been appropriate given how little they knew about the controversies.) And consider Michelle Bachmann was converted to a similar view about the HPV vaccine on the basis of a woman’s anecdote about her child. And then on the far left, you have the uplifting story of Robert F. Kennedy Jr, and his brief on how thimerosal supposedly causes autism.

So it should be no surprise that Donald Trump, a Birther, a Mirther, a mid-night Twitterer, should embrace the anti-vaccination movement. Trump has made it clear that he rejects evidence-based policy, and so no one should expect him to embrace a scientific policy that is driven by high-quality scientific evidence. According to Kennedy, Trump wants Kennedy to head up a “commission on vaccine safety and scientific integrity.” Michael D. Shear, Maggie Haberman & Pam Belluckjan, “Anti-Vaccine Activist Says Trump Wants Him to Lead Panel on Immunization Safety,” N.Y. Times (Jan. 10, 2017); Domenico Montanaro, “Despite The Facts, Trump Once Again Embraces Vaccine Skeptics,” National Public Radio (Jan. 10, 2017).

Who needs the National Academy of Medicine when you can put a yutzball lawyer in charge of a “commission”?

Some of the media refer to Robert F. Kennedy Jr. as a vaccine skeptic, but their terminology is grossly inaccurate and misleading. Kennedy is a vaccine denier; he has engaged in a vitriolic campaign against the safety and efficacy of vaccines. He has aligned himself with the most extreme deniers of science, medicine, and public safety, including the likes of Andrew Wakefield and Jenny McCarthy. Kennedy has not merely engaged hyperbolic rhetoric against vaccines, he has used his radio show on the lawsuit industry’s Ring of Fire, to advance his campaign against public health as well as to shill for the lawsuit industry on other issues. SeeRFK, Jr.: Science Shows That Autism — Mercury Link Exists – PT. ½,” Ring of Fire (Mar 8, 2011).

Kennedy should not be characterized as a skeptic, when he is a shrill ideologue, for whom science has no method that he is bound to respect. Back in July 2005, Kennedy published an article, “Deadly Immunity,” in both Rolling Stone and on Slate’s website. The article was a hateful screed against Big Pharma and government health agencies for an alleged conspiracy to hide the autism risks of thimerosal preservatives in vaccines. Several years later, on January 16, 2011, Salon retracted the article. Seehttps://en.wikipedia.org/wiki/Deadly_Immunity” entry in Wikipedia. See also Phil Plait, “Robert F. Kennedy Jr.: Anti-Vaxxer,” Slate (June 5 2013) (describing Kennedy as a full-blown anti-vaccination conspiracy theorist); Rahul K. Parikh, M.D., “Inside the vaccine-and-autism scare: A pediatrician traces the rise of the anti-vaccine movement that falsely linked thimerosal with autism and turned parents away from the most lifesaving medicine in history,” Salon (Sept. 22, 2008); Keith Kloor,Is Robert F. Kennedy Jr. Anti-Science?” Discover Magazine (June 1, 2013); Steven Novella, “RFK Jr.s Autism Conspiracy Theory,” (Jun 20 2007).

Back in 2008, President Obama apparently considered Robert Kennedy for a cabinet-level position, but on sober reflection, thought better of it. See Steven Novella, “Politics and Science – The RFK Jr. Test,” (Nov. 07 2008). The Wall Street Journal, joined by many others, are now urging Trump to think harder and better about the issue, perhaps with some evidence as well. See Alex Berezow & Hank Campbell, “Ignore Anti-Vaccine Hysteria, Mr. Trump: Robert F. Kennedy Jr.’s conspiracy theories have no place in the White House,” Wall Street J. (Jan. 10, 2017).