Friday, June 30, 2006

Who's Smarter? The FDA or the Surgeon General?

Some states have adopted a presumption of nondefectiveness (rebuttable or otherwise) for FDA-approved drugs and/or medical devices. Some "tort reformers" have even proposed that such a presumption be imposed on the states, preemptively, by federal statute. Personally, we think that would probably be a bad idea, for reasons ranging from the nature of the FDA approval process to considerations of federalism. But reasonable minds could differ.

We got to thinking, though. Shouldn't those advocating such a presumption also advocate, with equal zeal, a parallel presumption in favor of federal agency findings that support a generic causal link between some substance or product and disease -- e.g., the recent Surgeon General's Report linking second-hand smoke to various adverse health outcomes, even at the lowest exposures?

If not, why not? If anything, isn't the policy rationale for a presumption arguably stronger, for something like the Surgeon General's comprehensive study, than for the more provisional assessments of risk in initial FDA approvals?

And wouldn't a presumption in favor of agency findings of generic causation drive down the costs of litigation, by eliminating a host of frivolous Daubert motions?

Update 7/2/06: We've asked a "good question," says Prof. Childs.


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Fed. R. Evid. 702: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.