Healthy Skepticism Library item: 17758

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Publication type: Journal Article

Gostanian A
How the FDA can overturn Wyeth v. Levine
Am J Law Med. 2010; 36:(1):248-68.
http://www.ncbi.nlm.nih.gov/pubmed/20481407

Abstract:

In Wyeth v. Levine, the Supreme Court held that an FDA-approved drug label did not preempt state tort law. Although the Supreme Court did not defer to the FDA’s position, language in the opinion, and Breyer’s concurring opinion, suggest that the FDA may be able to abrogate Wyeth v. Levine using the administrative law doctrine originally announced in Chevron v. Natural Resources Defense Council. That is, the FDA may claim deference to its position in a future case involving the same legal questions. This Note explains how Wyeth impacts the Chevron doctrine and identifies how the FDA assertion that drug labels preempt state law may win in a future case.