Nathan Schachtman appropriately refers to the way in which “dicta infects Daubert” in his latest blogpost Siracusano Dicta Infects Daubert Decisions. Here the “dicta” (or dictum?) is a throwaway remark on (lack of) statistical significance and causal inference by the Supreme Court, in an earlier case involving the drug company Matrixx (Matrixx Initiatives, Inc. v. Siracusano). As I note in my post of last Feb,
“the ruling had nothing to do with what’s required to show cause and effect, but only what information a company is required to reveal to its shareholders in order not to mislead them (as regards information that could be of relevance to them in their cost-benefit assessments of the stock’s value and future price).”(See “Distortions in the Court”)
- A judge’s incidental expression of opinion, not essential to the decision and not establishing precedent.
- An incidental remark.
It was already surprising that the Supreme Court took up that earlier case; the way they handled the irrelevant statistical issues was more so. Continue reading
I see that Nathan Schachtman has had many interesting posts during the time I was away. His recent post endorses the idea of “a hierarchy of evidence”–but philosophers of “evidence-based” medicine generally question or oppose it, at least partly because of disagreement as to where to place RCTs in the hierarchy. What do people think?
Litigation arising from the FDA’s refusal to approval “health claims” for foods and dietary supplements is a fertile area for disputes over the interpretation of statistical evidence. A ‘‘health claim’’ is ‘‘any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication … characterizes the relationship of any substance to a disease or health-related condition.’’ 21 C.F.R. § 101.14(a)(1); see also 21 U.S.C. § 343(r)(1)(A)-(B).
Unlike the federal courts exercising their gatekeeping responsibility, the FDA has committed to pre-specified principles of interpretation and evaluation. By regulation, the FDA gives notice of standards for evaluating complex evidentiary displays for the ‘‘significant scientific agreement’’ required for approving a food or dietary supplement health claim. 21 C.F.R. § 101.14. SeeFDA – Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims – Final (2009).
If the FDA’s refusal to approve a health claim requires pre-specified criteria of evaluation, then we should be asking ourselves why have the federal courts failed to develop a set of criteria for evaluating health effects claims as part of its Rule 702 (“Daubert“) gatekeeping responsibilities. Why, after close to 20 years after the Supreme Court decided Daubert, can lawyers make “health claims” without having to satisfy evidence-based criteria?
Read the rest.
February 29th, 2012
Ken Feinberg, speaking at a symposium on mass torts, asks what legal challenges do mass torts confront in the federal courts. The answer seems obvious.
Pharmaceutical cases that warrant federal court multi-district litigation (MDL) treatment typically involve complex scientific and statistical issues. The public deserves having MDL cases assigned to judges who have special experience and competence to preside in cases in which these complex issues predominate. There appears to be no procedural device to ensure that the judges selected in the MDL process have the necessary experience and competence, and a good deal of evidence to suggest that the MDL judges are not up to the task at hand.
In the aftermath of the Supreme Court’s decision in Daubert, the Federal Judicial Center assumed responsibility for producing science and statistics tutorials to help judges grapple with technical issues in their cases. The Center has produced videotaped lectures as well as the Reference Manual on Scientific Evidence, now in its third edition. Despite the Center’s best efforts, many federal judges have shown themselves to be incorrigible. It is time to revive the discussions and debates about implementing a “science court.”
I am intrigued to hear Schachtman revive the old and controversial idea of a “science court”, although it has actually never left, but has come up for debate every few years for the past 35 or 40 years! In the 80s, it was a hot topic in the new “science and values” movement, but I do not think it was ever really put to an adequate experimental test. The controversy directly relates to the whole issue of distinguishing evidential and policy issues (in evidence-based policy), Continue reading