[JURIST] The US Supreme Court [official website; JURIST news archive] ruled [opinion, PDF] 6-3 Wednesday in Wyeth v. Levine [Cornell LII backgrounder; JURIST report] that the drug labeling requirements under the Federal Food, Drug, and Cosmetic Act (FDCA) [text] do not preempt state products liability laws. The case was initiated by a Vermont woman who brought a negligence and failure-to-warn products liability suit against pharmaceutical company Wyeth [corporate website], arguing that the company's failure to indicate the dangers of intravenously injected migraine and anti-nausea drug Phenergan eventually led to the amputation of her arm. Wyeth argued that any state-requested changes to the drug label would have violated Food and Drug Administration (FDA) [official website] requirements because FDA approval is based partly on the label, and that allowing state-requested changes to drug labels would contradict legislative intent by allowing an agency other than the FDA officially to determine drug safety. Writing for the majority, Justice John Paul Stevens said that a drug manufacturer and not the FDA bears primary responsibility for product labeling, and that a manufacturer may itself initiate strengthened warning labels to comply with state and federal requirements. Stevens concluded that:
If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the FDCA's 70-year history. ... Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.The decision upholds the Vermont Supreme Court affirmance [opinion text] of a $6.7 million jury award for the plaintiff.