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I am honored to testify in these hearings on FDA preemption of state product liability lawsuits relating to FDA-approved drugs and medical devices. I will focus mainly on pharmaceuticals. In doing so, I will address the practical consequences of FDA preemption of liability litigation, and will largely ignore the complex legal issues to be discussed by other witnesses. By way of background, I am an economist who has specialized in government regulation, tort liability, information, and FDA regulation, beginning with my experience in the Bureau of Economics at the Federal Trade Commission in the 1980s.

The central issue in these hearings is whether state tort litigation against FDA-approved drugs and devices ) especially lawsuits alleging failure to warn ) should be preempted by FDA regulation including the content of the labels that accompany all approved drugs and devices. A current case now before the Supreme Court, Wyeth v. Levine, may strongly affect the role, if any, of preemption.

A commonly held view is that state tort liability litigation can do much good and
little harm because such litigation provides added protection to patients and consumers through compensation for injury, better information in the form of new warnings and disclosures, and improved drug safety (e.g., Kennedy 2008; Glantz and Annas 2008). I believe these views are largely unsupported, however. Economic reasoning and historical experience strongly suggest that FDA preemption, if it becomes standard law, would actually tend to improve patient welfare.

John E. Calfee is a resident scholar at AEI.

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