Thursday, September 18, 2008

Supreme Court Poised to Enter Pre-Emption Debate -

Supreme Court Poised to Enter Pre-Emption Debate -, Sept. 18, 2008. The Court is reviewing a case from Vermont, in which a jury awarded damages against a drug company for failing to have a label warning against administering the drug through IV push. The company argues that the state law is pre-empted by a federal law requiring drug labels to be approved by the FDA.

The question on which the Supreme Court granted cert in Wyeth v. Levine, No. 06-1249 is:

Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration ("FDA") pursuant to FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.
The briefs are available here.

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