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

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.”

Print Friendly, PDF & Email

Comments are closed.