Supreme Court Hears Its Second Significant Preemption Case This Term
The United States Supreme Court heard oral argument today in Wyeth v. Levine, No. 06-1249 – its second significant preemption case this term – in which the Court will address the preemptive reach of the Federal Food, Drug, and Cosmetic Act (the "FDCA"). Specifically at issue is whether the Food and Drug Administration’s (the "FDA") drug approval process impliedly preempts state tort laws that would impose duties on drug manufacturers exceeding those set forth by the FDA pursuant to the FDCA. The Court’s decision in Levine has been much anticipated because of its potential to resolve under what circumstances pharmaceutical companies may be liable for negligence and failure-to-warn claims under state law where the drugs and warnings at issue satisfied the FDA’s approval process.