TORTINI

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

Contrivance Standard Applied to Gatekeepers and Expert Witnesses

October 1st, 2014

In Rink v. Cheminova, Inc., 400 F.3d 1286 (11th Cir. 2005), the Eleventh Circuit’s articulated a “contrivance standard,” which suggested that a district court “may properly consider whether the expert’s methodology has been contrived to reach a particular result.” Id. at 1293 & n.7; see alsoThe Contrivance Standard for Expert Witness Gatekeeping” (Sept. 28, 2014).

Although this standard has some appeal, it raises questions of motives that can complicate the Rule 702 inquiry into whether an purported opinion is “knowledge.” A less psychoanalytic inquiry into the expert witness’s motivation should generally be the first line of approach.

In the Zoloft MDL, the trial court banished Dr. Anick Bérard from federal court birth defect cases because of her unprincipled and inexplicable cherry picking of data, relied upon for her causation opinions. See In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig. MDL No. 2342; 12-md-2342, 2014 U.S. Dist. LEXIS 87592; 2014 WL 2921648 (E.D. Pa. June 27, 2014) (Rufe, J.). The “contrivance” was objectively obvious and manifest in double-counting data points, and ignoring point estimates that were contrary to the desired outcome, even from papers that provided point estimates that were selectively embraced.

In the Chantix MDL, the trial court found the defendant to have harped on methodological peccadilloes but obviously did not like the beatific music (3x). Cherry picking was going on, but it was perfectly acceptable to this MDL court:

“Why Dr. Kramer chose to include or exclude data from specific clinical trials is a matter for crossexamination, not exclusion under Daubert.

In re Chantix (varenicline) Prods. Liab. Litig., 889 F. Supp. 2d 1272, 1288 (2012) (MDL No. 2092) (permitting Dr. Shira Kramer to testify on causation despite her embracing a “weight of the evidence” method that turned largely on‘‘subjective interpretations’’ of various, undescribed, non-prespecified lines of evidence).

The differing approaches to cherry picking are hard to reconcile other than to note that Chantix had drawn a “black box” warning from the FDA, and the SSRIs involved in Zoloft had not been given any heightened warning from the FDA, foreign agencies, or any professional society. FDA labeling, of course, should not have been determinative of the causation question. The mind of the gatekeeper, however, is inscrutable.

 

 

CHARGE: Coyness in Disclosing Conflicts

October 1st, 2014

Back in June, the Environmental Health Perspectives posted an “in-press” version of a study from the CHARGE group on autism disorders and pesticide exposures. This month, the October issue of EHP has the final version of the article. Janie F. Shelton, Estella M. Geraghty, Daniel J. Tancredi, Lora D. Delwiche, Rebecca J. Schmidt, Beate Ritz, Robin L. Hansen, and Irva Hertz-Picciotto, “Neurodevelopmental disorders and prenatal residential Proximity to Agricultural pesticides: the CHARGE Study,” 122 Envt’l Health Persp. (2014).

At the time of the in-press publication, I posted a plea that the media pay attention to principal investigator Dr. Hertz-Picciotto’s conflict of interest disclosure, and its failure to acknowledge her advocacy role on the advisory board of Autism Speaks. SeeNIEHS Study – CHARGE Failure to Disclose Conflicts of Interest” (June 23, 2014). The published version does indeed, by way of an erratum, acknowledge Hertz-Picciotto’s, and other authors’, membership in Autism Speaks, and their regret in omitting this information earlier.

Unfortunately, the erratum fails to mention that Hertz-Picciotto also serves on the advisory board of the radically anti-chemical Healthy Child, Healthy World organization, located in California (12100 Wilshire Blvd. Suite 800, Los Angeles CA 90025). Healthy Child Healthy World is a California non-profit corporation that advocates to:

“Demand corporate accountability
Engage communities for collective action
Support safer chemicals and products
Influence legislative and regulatory reform.”

It looks as though more regrets and more errata are in order.

The Last Squirmish Between Irving Selikoff and Sir Richard Doll

September 30th, 2014

In one of his last publications before he died, Dr. Selikoff reflected on the ethical dimensions of epidemiology. He recounted the development of our understanding of the lung cancer hazards of asbestos and smoking, and noted that there had been “random instances” of lung cancer cases reported among asbestos workers in the 1930s and 1949s, but “[w]ith the continued growth of the asbestos industry, it was deemed wise to epidemiologically examine the proposed association. This was done in an elegant, innovative, well-considered study by Richard Doll [7], a study which anyone of us would have been proud to report in 1955.” Irving J. Selikoff, “Statistical Compassion,” 55 J. Clin. Epidemol. 141S, 142S (1991).

Despite his praise for Doll’s work, Selikoff goes on to downplay Doll’s achievement by explaining how Doll supposedly missed a synergistic multiplicative interaction between asbestos exposure and smoking, which Selikoff claimed to have found a decade later:

“Not only was the association [with smoking] not yet established, indicating the need for its investigation in cohort studies, but smoking histories were not available (and indeed, many of the workers involved may not have smoked cigarettes, having begun their asbestos exposure at a time when cigarette smoking was considerably less common, even among blue collar workers). We would want such information now, but these studies were accomplished at an earlier, less informed, time.”

Id. at 143S

This short passage is revealing. In 1955, epidemiology was still a relatively young science, and it was Doll who energetically was developing and implementing its methods. Doll’s use of his cohort study was not undertaken just because it was deemed “wise,” but because the method had evolved to the point that Doll could cast offer the asbestos company in question a reasonably rigorous method of answering their “wise” concern.

Contrary to Selikoff’s suggestions, the smoking association was better established in 1955, when Doll published, than was the asbestosis association. By the time Doll published his famous paper on the association between asbestosis and lung cancer, he had published three studies on the association between smoking and lung cancer. Interestingly, Doll later acknowledged that his failure to obtain smoking histories was purely an oversight. By the time Selikoff undertook his studies of asbestos insulators in the late 1950s, a wise investigator would have known that he needed to be very careful smoking histories to study the role of asbestos in an exposed cohort.

Perhaps more revealing yet, however, was Selikoff’s counterfactual assertion that Doll’s 1955 study was conducted too early to assess the role of tobacco in lung cancers observed in the early 1950s. By the early 1950s, cigarette smoking was well established in both in the U.K., and in the U.S., and had been so for several decades. Here are the data for the United States:

 

Correlation between smoking and lung cancer in US males, showing a 20-year time lag between increased smoking rates and increased incidence of lung cancer.

Correlation between smoking and lung cancer in US males, showing a 20-year time lag between increased smoking rates and increased incidence of lung cancer.

National Cancer Institute Figure 2003

And here are the data from the United Kingdom:

 

Figure 1

Figure 1

Figure 1, from Robert Platt, et al., Smoking and Health: A Report of The Royal College of Physicians of London on Smoking in relation to Cancer of the Lung and Other Diseases 3 (1962).

 

The Contrivance Standard for Expert Witness Gatekeeping

September 28th, 2014

According to Google ngram, the phrase “junk science” made its debut circa 1975, lagging junk food by about five years. SeeThe Rise and Rise of Junk Science” (Mar. 8, 2014). I have never much like the phrase “junk science” because it suggests that courts need only be wary of the absurd and ridiculous in their gatekeeping function. Some expert witness opinions are, in fact, serious scientific contributions, just not worthy of being advanced as scientific conclusions. Perhaps better than “junk” would be patho-epistemologic opinions, or maybe even wissenschmutz, but even these terms might obscure that the opinion that needs to be excluded derives from serious scientific, only it is not ready to be held forth as a scientific conclusion that can be colorably called knowledge.

Another formulation of my term, patho-epistemology, is the Eleventh Circuit’s lovely “Contrivance Standard.” Rink v. Cheminova, Inc., 400 F.3d 1286, 1293 & n.7 (11th Cir. 2005). In Rink, the appellate court held that the district court had acted within its discretion to exclude expert witness testimony because it had properly confined its focus to the challenged expert witness’s methodology, not his credibility:

“In evaluating the reliability of an expert’s method, however, a district court may properly consider whether the expert’s methodology has been contrived to reach a particular result. See Joiner, 522 U.S. at 146, 118 S.Ct. at 519 (affirming exclusion of testimony where the methodology was called into question because an “analytical gap” existed “between the data and the opinion proffered”); see also Elcock v. Kmart Corp., 233 F.3d 734, 748 (3d Cir. 2000) (questioning the methodology of an expert because his “novel synthesis” of two accepted methodologies allowed the expert to ”offer a subjective judgment … in the guise of a reliable expert opinion”).”

Note the resistance, however, to the Supreme Court’s mandate of gatekeeping. District courts must apply the statutes, Rule of Evidence 702 and 703. There is no legal authority for the suggestion that a district court “may properly consider wither the expert’s methodology has been contrived.” Rink, 400 F.3d at 1293 n.7 (emphasis added).

The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.