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THE SUPREME Court struck a blow to FDA pre-emption of state laws with a 6-3 decision in Wyeth v. Levine finding the company liable for a failure-to-warn claim under Vermont state law.
Writing for the majority, Justice Stevens said Wyeth's argument for federal pre-emption "relies on an untenable interpretation of congressional intent and an overbroad view of an agency's power to pre-empt state law." Stevens shot down a 2006 FDA statement in support of pre-emption as "entitled to no weight" and contrary to congressional intent, noting that "FDA traditionally regarded state law as a complementary form of drug regulation" and asserting that while the agency has limited resources to monitor marketed drugs, manufacturers "have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge."
"Failure-to-warn actions, in particular, lend...