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Pre-Emption and the FDA

Both the New York Times (on 7/25) and the Wall St. Journal (on 7/26) are covering the brouhaha surrounding the Bush Administration's push to get federal courts to recognize that FDA approved labels pre-empt state product liability "failure to warn" suits.

The WSJ article requires a subscription, so I can't reproduce it here. For those who subscribe to the Journal online, here is the URL. As for the NYT, here is a non-subscription based copy of their article.

The issue is an important one, that has been raised by Walter Olson on the Overlawyered site. If I claim that drug X "caused" a victim to commit suicide, and that the fact sheet accompanying drug X should have mentioned this risk, but FDA deliberately declined to specify such a risk on the approved fact sheet (on the grounds that, say, more suicides would be "caused" by failure to take drug X than by taking drug X), then should a jury be allowed to find the drug defective in the absence of such a warning? Courts have divided on such issues, and as we tort professors know, the United States Supreme Court's "pre-emption" caselaw is extremely muddled.

Whether or not these warning labels should be specified by a federal regulatory agency is not an issue for this posting. But if they are specified by a federal agency, then I believe the soundest interpretation of the "Supremacy Clause" of the constitution has them pre-empt any incompatible "failure to warn" products liability suit under state law. The Administration has it right therefore, I think, and the complaint by Dem. Rep. Hinchey (discussed in the Times and Journal articles) is unwarranted.

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.