TORTINI

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

Siracusano Dicta Infects Daubert Decisions

September 22nd, 2012

Gatekeeping is sometimes  intellectually challenging, but the challenge does not excuse sloppy thinking.  Understandably, judges will sometimes misunderstand the relevant science.  The process, however, allows the public and the scientific community to see what is happening in court cases, rather than allowing the critical scientific reasoning to be hidden in the black box of jury determinations.  This transparency can and should invite criticism, commentary, corrections, and consensus, when possible.

Bad legal reasoning is much harder to excuse.  The Supreme Court, in Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011), unanimously affirmed the reversal of a trial court’s Rule 12(b)(6) dismissal of a securities fraud class action.  The corporate defendant objected that the plaintiffs failed to plead statistical significance in alleging causation between Zicam and the loss of the sense of smell.  The Supreme Court, however, made clear that causation was not required to make out a claim of securities fraud.  It was, and would be, sufficient for the company’s product to have raised sufficient regulatory concerns, which in turn would bring regulatory scrutiny and action that would affect the product’s marketability.

The Supreme Court could have disposed of the essential issue in a two page per curiam opinion.  Instead the Court issued an opinion signed by Justice Sotomayor, who waxed carelessly about causation and statistical significance, which discussion was not necessary to the holding.  Not only was Justice Sotomayor’s discussion obiter dicta, but the dicta were demonstrably incorrect. Matrixx Unloaded (Mar. 29, 2011).

The errant dicta in Siracusano has already led one MDL court astray:

“While the defendant repeatedly harps on the importance of statistically significant data, the United States Supreme Court recently stated that ‘[a] lack of statistically significant data does not mean that medical experts have no reliable basis for inferring a causal link between a drug and adverse events …. medical experts rely on other evidence to establish an inference of causation.’ Matrixx Initiatives, Inc. v. Siracsano, 131 S.Ct. 1309, 1319 (2011).”

Memorandum Opinion and Order at 22, In re Chantix (Varenicline) Products Liability Litigation, MDL No. 2092, Case 2:09-cv-02039-IPJ Document 642 (N.D. Ala. Aug. 21, 2012)[hereafter cited as Chantix].  See Open Admissions for Expert Witnesses in Chantix Litigation.

It was only a matter of time before the Supreme Court’s dictum would be put to this predictably erroneous interpretation.  SeeThe Matrixx Oversold” (April 4, 2011).  Within two weeks, the error in Chantix propagated itself in another MDL case, with another trial court succumbing to the misleading dicta in Justice Sotomayor’s opinion.  See Memorandum in Support of Separate Pretrial Order No. 8933, Cheek v. Wyeth Pharm. Inc. (E.D.Pa. Aug. 30, 2012)(Bartle, J.).

In Cheek, Judge Harvey Bartle rejected a Rule 702 challenge to plaintiffs’ expert witness’s opinion.  I confess that I do not know enough about the expert witness’s opinion or the challenge to assess Judge Bartle’s conclusion.  Judge Bartle, however, invoked the Matrixx decision for the dubious proposition that:

Daubert does not require that an expert opinion regarding causation be based on statistical evidence in order to be reliable. Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309, 1319 (2011). In fact, many courts have recognized that medical professionals often base their opinions on data other than statistical evidence from controlled clinical trials or epidemiological studies. Id. at 1320.”

Cheek at 16.  The Cheek decision is a welter of non-sequiturs.  The fact that in some instances statistical evidence is not necessary is hardly a warrant to excuse the lack of statistical evidence in every case. The truly disturbing gaps in reasoning, however, are not scientific, but legal. Siracusano was not a “Daubert” opinion; and Siracusano does not, and cannot, support the refusal to inquire whether statistical evidence was necessary in a causation opinion, in main part because causation was not at issue in Siracusano.

 

 

 

 

 

 

 

It’s Alimentary, My Dear Watson

September 20th, 2012

Mr. Watson, who claimed to have consumed thousands of bags of popcorn with diacetyl, sued for bronciolitis obliterans allegedly caused by the diacetyl.

Actually, with the help of frequent testifier David Egilman, Wayne Watson claimed his lung injury was inhalational.

The trial judges in Watson denied essentially the same challenges that were sustained in Newkirk v. ConAgra Foods, Inc., 727 F. Supp. 2d 1006 (E.D.Wash. 2010), aff’d, 438 Fed.Appx. 607 (9th Cir. 2011).

Yesterday, the jury returned a verdict for compensatory damages of $1.2 million, and punitive damages of $6 million, against the defendants, some of which had settled before trial.

For a predictably misleading, mainstream media account that fails to mention the interesting Daubert exclusions and defense verdicts in this litigation, see  Colorado man Wayne Watson wins $7 million in “popcorn lung” lawsuit; and ‘Popcorn Lung’ Lawsuit Nets $7.2M Award (Sept. 20, 2012).

The supermarket defendant at trial should certainly appeal.  It remains to be seen who gets the last pop in this case.

Bipartisan Junk Science – Pork-Barrel Causation

September 19th, 2012

Despite the hand waving and finger pointing, junk science is embraced by both political parties in the United States, when it suits their purposes.  Both parties want to have God and science on their sides.

Congress created September 11th Victim Compensation Fund, 49 USC § 40101, also known as the James Zadroga 9/11 Health and Compensation Act (P.L. 111-347) (signed into law in January 2011). The Act was a touching acknowledgement of the dedication and sacrifices of first responders to the World Trade Center and Pentagon victims of an Islamic jihad. Being a victim, however, implies that the harm to be compensated was caused by the attack and its consequences.  The New York politicians soon learned that causality can be turned into a very malleable concept.

The law allocated over $4 billion for medical screening and treatment of fire fighters, policemen, emergency responders, and survivors.  Most of the covered conditions were acute onset respiratory and mental disorders caused by gases, fumes, dusts, and stresses, to which the workers were exposed.  The law also made the director of CDC’s National Institute for Occupational Safety and Health (NIOSH), the head of a World Trade Center Health Program, which could add new conditions to the list of compensable diseases, based upon a review of scientific evidence.

In September 2011, several New York congressmen and Senators petitioned the director, citing flimsy or non-existent scientific evidence, to add cancer to the list.  Senators Kirsten Gillibrand (D-NY) and Charles Schumer (D-NY), and Representatives Carolyn Maloney (D-NY), Jerrold Nadler (D-NY), Peter King (R-NY), Charles Rangel (D-NY), Nita Velazquez (D-NY), Michael Grimm (R-NY),  and Yvette Clark (D-NY), made their request, citing R. Zeig-Owens, M. Webber, C.B. Hall, et al., “Early assessment of cancer outcomes in New York City firefighters after the 9/11 attacks: an observational cohort study,” 378 Lancet 898 (2011).

This is pork barrel politics masquerading as sympathy for putative victims.  The Zeig-Owens study reported a non-statistically significant standardized incidence ratio for all cancer, of either 1.10 (95% CI 0.98–1.25), with a comparison group of the generalized U.S. male population, or 1.19 (95% CI 0.96–1.47), with unexposed firefighters as a comparison group, and corrected for possible surveillance bias.  Of course, given that there is no disease of cancer, the composite end point is not particularly meaningful.

Here are the authors’ (including Dr. Prezant’s) published interpretation of the data:

“We reported a modest excess of cancer cases in the WTC-exposed cohort. We remain cautious in our interpretation of this finding because the time since 9/11 is short for cancer outcomes, and the reported excess of cancers is not limited to specific organ types. As in any observational study, we cannot rule out the possibility that effects in the exposed group might be due to unidentified confounders.”

Zeig-Owens, at 898.  The Zeig-Owens study did not support any conclusions of causality between the workers’ exposures in 2001, and any type of cancer. See NIOSH Report Sets Up Run on September 11th Victim Compensation Fund by Non-Victims.

The WTC Health Program director requested recommendations from the program’s Scientific – Technical Advisory Committee (STAC), whether to add cancer generally, or any particular kind of cancer, to the Zadroga Act’s list of compensable conditions.  In April 2012, the STAC made its recommendations, essentially relying upon likely exposures, without any consideration of individual dose, duration, latency, and without any serious consideration of the available epidemiologic evidence.

The STAC claimed that the Lancet study reported statistically significant excesses of cancer; it did not. The Committee also failed to come to grips with the biological implausibility of excess rates of solid malignant tumors presenting within less than a decade since exposure:

“Given that cancer latencies for solid tumors average 20 years or more, it is noteworthy that the published FDNY study of fire fighters showed a statistically significant excess in all-site cancer with only 7 years of follow-up.”

In June 2012, NIOSH director, Dr. Howard, reported that he was inclined to accept the STAC’s recommendation, but held open a public comment period.  See Anemona Hartocollis, “Sept. 11 Health Fund Given Clearance to Cover Cancer,” N.Y. Times (June 8, 2012).  Not surprising, given the political pressure, the WTC Health Program director promulgated his final rule to include 50 types of cancer, including many that occurred less often than expected in the Zeig-Owens study.

This decision ignores appropriate scientific methodology for reaching causal conclusions.  Worse than its intellectual shabbiness, the decision insults the true victims of the jihad terrorism.

The rule is effective October 12, 2012.

 

Watson Popcorn Case Pops Along

September 8th, 2012

Earlier today, I discussed the pending motion that would have limited, or eliminated, Dr. Egilman’s testimony in the Watson diacetyl case. See Good’s Expert Witness Opinion Not Good Enough in Tenth Circuit.  Apparently, Chief Judge Daniel denied the defendant’s renewed Rule 702 motion, and so “this trial must be tried.”  Whether the gatekeeping was sufficiently exact, time will tell.

Details to follow.