TORTINI

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

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.”

Statistical Gobbledygook Goes to the Supreme Court

October 20th, 2017

Back in July, my summer slumber was rudely interrupted by an intemperate, ad hominem rant from statistican Sander Greenland. Greenland’s rant concerned my views of the the Supreme Court’s decision in Matrixx Initiatives v. Siracusano, 563 U.S. 27 (2011).

Greenland held forth, unfiltered, on Deborah Mayo’s web blog, where he wrote:

Glad to have finally flushed out Schachtman, whose blog did not allow my critical dissenting comments back when this case first hit. Nice to see him insult the intellect of the Court too, using standard legal obfuscation of the fact that the Court is entitled to consider science, ordinary logic, and common sense outside of that legal framework to form and justify its ruling – that reasoning is what composes the bulk of the opinion I linked. Go read it and see what you think without the smokescreen offered by Schachtman.”

A megateam of reproducibility-minded scientists look to lowering the p-value,” Error Statistics (July 25, 2017).

Oh my! It is true that my blog does not have comments enabled, but as I have written on several occasions, I would gladly welcome requests to post opposing views, even those of Sander Greenland. On Deborah Mayo’s blog, I had the opportunity to explain carefully why Greenland has been giving a naïve, mistaken characterization of the holding of Matrixx Initiatives, in his expert witness reports for plaintiffs’ counsel, as well as in his professional publications. Ultimately, Greenland ran out of epithets, lost his enthusiasm for the discussion, and slunk away into cyber-silence.

I was a bit jarred, however, by Greenland’s accusation that I had insulted the Court. Certainly, I did not use any of the pejorative adjectives that Greenland had hurled at me; rather, I simply have given legal analysis of the Court’s opinions and a description of the legal, scientific, and statistical errors therein.1 And, to be sure, other knowledgeable writers and evidence scholars, have critiqued the Court’s decision and some of the pronouncements of the parties and the amici in Matrixx Initiatives2.

This week, John Pfaff, a professor at Fordham Law School, published an editorial in the New York Times, to argue that “The Supreme Court Justices Need Fact-Checkers,” N.Y. Times (Oct. 18, 2017). No doubt, Greenland would consider Pfaff’s editorial to be “insulting” to the Court, unless of course, Greenland thinks criticism can be insulting only if it challenges views he wants to see articulated by the Court.

In support of his criticism of the Court, Pfaff adverted to the Chief Justice’s recent comments in the oral argument of a gerrymandering case, Gill v. Whitford. In a question critical of the gerrymander challenge, Chief Justice Roberts described the supporting evidence:

it may be simply my educational background, but I can only describe as sociological gobbledygook.”

Oral Argument before the U.S. Supreme Court at p.40, in Gill v. Whitford, No. 16-1161 (Oct. 3, 2017). The Chief Justice’s dismissive comments about gobble may well have been provoked by an amicus brief filed on behalf of 44 election law, scientific evidencce, and empirical legal scholars, who explored the legal and statistical basis for striking down the Wisconsin gerrymander. See Brief of Amici Curiae, of 44 Election Law, Scientific Evidence, and Empirical Legal Scholars, filed in Gill v. Whitford, No. 16-1161 (Sept. 1, 2017).

As with Greenland’s obsequious respect for the Matrixx Initiatives opinion, no one is likely to have been misled by Chief Justice Roberts’ false modesty. John Roberts was graduated summa cum laude from Harvard College in three years, although with a major in a “soft” discipline, history. He went on to Harvard Law School, where he was the managing editor of the Harvard Law Review, and was graduated magna cum laude. As a lawyer, Roberts has had an extraordinarily successful career. And yet, the Chief Justice went out of his way to disparage the mathematical and statistical models used to show gerrymandering in the Gill case, as “gobbledygook.” Odds are that the Chief Justice was thus not deprecating his own education; yet, inquiring minds might wonder whether that education was deficient in mathematics, statistics, and science.

Policy is a major part of the court’s docket now, whether the Justices likes it or not. The Justices cannot avoid adapting to the technical requirements of scientific and statistical issues, and they cannot simply dismiss evidence they do not understand as “gobbledygook.” Referencing a recent ProPublica report, Professor Pfaff suggests that the Supreme Court might well employ independent advisors to fact check their use of descriptive statistics3

The problem identified by Pfaff, however, seems to implicate a fundamental divide between the “two cultures” of science and the humanities. See C.P. Snow, The Rede Lecture 1959. Perhaps Professor Pfaff might start with his own educational institution. The Fordham University School of Law does not offer a course in statistics and probability; nor does it require entering students to have satisfied a requirement of course work in mathematics, science, or statistics. The closest offering at Fordham is a course on accounting for lawyer, and the opportunity to take a one-credit course in “quantitative methods” at the graduate school.

Fordham School of Law, of course, is hardly alone. Despite cries for “relevancy” and experiential learning in legal education, some law schools eschew courses in statistics and probability for legal applications, sometimes on the explicit acknowledgement that such courses are too “hard,” or provoke too much student anxiety. The result, as C.P. Snow saw over a half century ago, is that lawyers and judges cannot tell gobbledygook from important data analysis, even when it smacks them in the face.


1 With David Venderbush of Alston & Bird LLP, I published my initial views of the Matrixx case, in the the form of a Washington Legal Foundation Legal Backgrounder, available at the Foundation’s website. See Schachtman & Venderbush, “Matrixx Unbounded: High Court’s Ruling Needlessly Complicates Scientific Evidence Principles,” 26 (14) Legal Backgrounder (June 17, 2011). I expanded on my critique in several blog posts. See, e.g., Matrixx Unloaded” (Mar. 29, 2011); The Matrixx Oversold” (Apr. 4, 2011); The Matrixx – A Comedy of Errors” (Apr. 6, 2011); De-Zincing the Matrixx” (Apr. 12, 2011); “Siracusano Dicta Infects Daubert Decisions” (Sept. 22, 2012).

2 See David Kaye, “The Transposition Fallacy in Matrixx Initiatives, Inc. v. Siracusano: Part I” (Aug. 19, 2011), and “The Transposition Fallacy in Matrixx Initiatives, Inc. v. Siracusano: Part II” (Aug. 26, 2011); David Kaye, “Trapped in the Matrixx: The U.S. Supreme Court and the Need for Statistical Significance,” BNA Product Safety & Liability Reporter 1007 (Sept. 12, 2011).

Love that Hormesis to Pieces

October 12th, 2017

Hermann Joseph Muller was an American biologist who won the Nobel Prize in 1946, for Physiology or Medicine, for his work on fruit fly genetics. In his Nobel Prize speech, Muller opined that there was no threshold dose for radiation-induced mutagenesis. Muller’s speech became a locus of support for what later became known as the “linear no threshold” (LNT) theory of carcinogenesis.

Muller was an ardent eugenicist, although of the communist, not the Nazi, variety.1 After 1932, Muller’s political enthusiasms took him to the Soviet Union, where Muller blithely ignored murderous purges and famines, in order to pursue his scientific interests for the greater glory of the Proletarian Dicatorship.2 Muller became enamored of a People’s eugenics program. On May 5, 1936, Muller wrote to “Comrade Stalin,” “[a]s a scientist with confidence in the ultimate Bolshevik triumph throughout all possible spheres of human endeavor,” to offer the brutal dictator “a matter of vital importance arising out of my own science – biology, and, in particular, genetics.”3

Comrade Stalin was underwhelmed by Muller’s offer, and threw his lot in with Trofim Lysenko. A disheartened Muller managed to extricate himself from the Soviet fatherland, but not so much from its politics and ideology4. After returning to the United States, he remained active in noteworthy liberal and progressive political activities. Alas, he also seemed to remain a Communist fellow traveler, who found time to criticize only the Soviet embrace of Lysenkoism and its treatment of dissident geneticists (such as himself), with nary a mention of Ukrainian farmers, political dissidents, or the Soviet subjugation of eastern and central Europe.5

In retreating from his Soviet homeland, Muller did not abandon his eugenic vision for the United States. In 1966, Muller urged the immediate establishment of sperm banks for “outstanding men,” such as himself, to make deposits for use in artificial insemination6

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

Back in a 1976, George E. P. Box outlined his notion that all models are wrong even though some may be useful7. The LNT model, as devised by Muller and embraced by regulatory agencies around the world, has long since lost its usefulness in describing and predicting biological phenomena. LNT is scientific in the sense that it is testable and falsifiable; LNT has been tested and falsified. Muller’s model ignores relevant biological processes of tolerance, defense, and adaptation8

The resilience of the LNT seems to be due to the advocacy of scientists and regulators who find the simplistic LNT model to be useful in ensuring regulation of, and compensation for, low-dose exposures. The perpetual machine litigation created with asbestos comes to mind. Other “political scientists” come to mind as well. Theory and data are often in tension, but at the end of any debate, scientists are obligated to “save the phenomena.” Fortunately, there are scientists who are challenging the dominance of the LNT model, and who are pointing out where the model just does not fit the data9.

In the United States, Muller’s theories were subjected to some real-world tests. In May 1947, Muller warned of the possible evolution of evil monsters born to Japanese survivors of Hiroshima and Nagasaki, on the basis of his assessment that the atomic bombs had produced countless mutants. Later that year, however, Austin Brues, director of the Argonne National Laboraty, published his findings of children born to Hiroshima survivors, who had no more mutations than baseline expectation10.

Notwithstanding the shaky evidentiary foundations of Muller’s views, his prestige as a Nobel laureate encouraged the adoption and promotion of the LNT model by the National Academy of Sciences’ Biological Effects of Atomic Radiation (BEAR) I Genetics Panel. Edward J. Calabrese, a prominent toxicologist in the Department of Environmental Health Sciences, School of Public Health and Health Sciences, University of Massachusetts, has taken pains, on multiple occasions, to trace the genealogy of this error. His most recent, and most succinct effort, is a worthwhile read for policy makers, judges, and lawyers who want to understand the historical dimension of the LNT model11. A fuller bibliography is set out as an appendix to this post.


 

1 Herman Joseph Muller, Out of the Night – a Biologist’s View of the Future (1935).

2 Elof Alex Carlson, Genes, Radiation, and Society: The Life and Work of H.J. Muller (1981).

3 John Glad, “Hermann J. Muller’s 1936 Letter to Stalin,” 43 The Mankind Quarterly 305 (2003).

4 See, e.g., Peter J. Kuznick, Beyond the Laboratory: Scientists as Political Activists in 1930’s America 121 (1987).

5 Hermann J. Muller, “The Crushing of Genetics in the USSR,” 4 Bull. Atomic Scientists 369 (1948). Some have attempted to protect Muller’s conduct by arguing that he testified before the House Un-American Activities Committee, where he was critical of Soviet restrictions on secondary education. See Thomas D. Clark, Indiana University: Midwestern Pioneer 310 (1977). Given Muller’s privileged position to observe first hand what had happened to Ukrainian farmers and others, this coming forward on Soviet education seems feeble indeed.

6 See Sperm Banks Urged by Nobel Laureate,” N.Y. Times (Sept. 13, 1966).

7 See George E. P. Box, “Science and Statistics,” 71 J. Am. Stat. Ass’ 791 (1976); George E. P. Box, “Robustness in the strategy of scientific model building,” in R. L. Launer & G.N. Wilkinson, Robustness in Statistics at 201–236 (1979); George E. P. Box & Norman Draper, Empirical Model-Building and Response Surfaces at 74 (1987) (“Remember that all models are wrong; the practical question is how wrong do they have to be to not be useful.”).

8 See, e.g., Adam D. Thomas, Gareth J. S. Jenkins, Bernd Kaina, Owen G. Bodger, Karl-Heinz Tomaszowski, Paul D. Lewis, Shareen H. Doak, and George E. Johnson, “Influence of DNA Repair on Nonlinear Dose-Responses for Mutation,” 132 Toxicol. Sci. 87 (2013).

9 See, e.g., Bill Sacks & Jeffry A. Siegel, “Preserving the Anti-Scientific Linear No-Threshold Myth: Authority, Agnosticism, Transparency, and the Standard of Care,” 15 Dose-Response: An Internat’l J. 1 (2017); Charles L. Sanders, Radiobiology and Radiation Hormesis: New Evidence and its Implications for Medicine and Society (2017).

10 William Widder, “Probe Effects of Atom Bomb: Study Betrays No Evidence of Mutations,” Greensburg Daily News (Greensburg, Indiana) at 22 (Mon, Nov. 24, 1947).

11 Edward J.Calabrese, “The Mistaken Birth and Adoption of the LNT: An Abridged Version,” 15 Dose-Response: An Internat’l J. (2017).


Appendix

Edward J.Calabrese & Linda A. Baldwin, “Chemical hormesis: its historical foundations as a biological hypothesis,” 19 Human & Experimental Toxicol. 2 (2000)

Edward J. Calabrese and Linda A. Baldwin, “Hormesis: U-shaped dose responses and their centrality in toxicology,” 22 Trends Pharmacol. Sci. 285 (2001)

Edward J.Calabrese, “Hormesis: a revolution in toxicology, risk assessment and medicine: Re-framing the dose–response relationship,” 5 Eur. Mol. Bio. Org. Reports S37 (2004)

Edward J. Calabrese & Robyn Blain, “The occurrence of hormetic dose responses in the toxicological literature, the hormesis database: an overview,” 202 Toxicol. & Applied Pharmacol. 289 (2005);

Edward J. Calabrese, “Pain and U-shaped dose responses: occurrence, mechanisms and clinical Implications,” 38 Crit. Rev. Toxicol. 579 (2008)

Edward J. Calabrese, “Neuroscience and hormesis: overview and general findings,” 38 Crit. Rev. Toxicol. 249 (2008)

Edward J. Calabrese, “Linear No Threshold (LNT) – The New Homeopathy,” 31 Envt’l Toxicol. & Chem. 2723 (2012)

Edward J. Calabrese, “Muller’s Nobel Prize Lecture: When Ideology Prevailed over Science,” 126 Toxicol. Sci. 1 (2012)

Edward J. Calabrese, “How the U.S. National Academy of Sciences misled the world community on cancer risk assessment: new findings challenge historical foundations of the linear dose response, 87 Arch. Toxicol. 2063 (2013)

Edward J. Calabrese, “On the origins of the linear no-threshold (LNT) dogma by means of untruths, artful dodges and blind faith,” 142 Envt’l Research 432 (2015)

Edward J. Calabrese, “An abuse of risk assessment: how regulatory agencies improperly adopted LNT for cancer risk assessment,” 89 Arch. Toxicol. 647 (2015)

Edward J. Calabrese, “LNTgate: How scientific misconduct by the U.S. NAS led to governments adopting LNT for cancer risk assessment,” 148 Envt’l Research 535 148 (2016)

Edward J. Calabrese, “The threshold vs LNT showdown: Dose rate findings exposed flaws in the LNT model part 1. The Russell-Muller debate,” 154 Envt’l Res. 435 (2017)

Edward J. Calabrese, “The threshold vs LNT showdown: Dose rate findings exposed flaws in the LNT model part 2. How a mistake led BEIR I to adopt LNT,” 154 Envt’l Res. 452 (2017)

Lawsuit Magic – Turning Talcum into Wampum

August 27th, 2017

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

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

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

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

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

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

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

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

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

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

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


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

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

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

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