The U.S. Supreme Court ruled that the Food and Drug Administrations authority to regulate drug safety doesnt pre-empt the right of consumers to sue drugmakers for flawed labeling under state-law liability.
The widely anticipated decision addresses a case in which musician Diana Levine sued Wyeth after an injection of the companys nausea drug Phenergan caused gangrene and the amputation of her forearm. A Vermont court awarded Levine $6.8 million, finding that the drugs FDA-approved labeling failed to sufficiently warn clinicians of the risk of administering the drug with an intravenous push rather than a drip. Wyeth appealed, arguing that such claims obstruct the FDAs authority and that federal law precluded stricter warnings without prior FDA approval.
Justice John Paul Stevens, writing for the 6-3 majority, called the first argument an untenable interpretation of congressional intent and the other premised on a misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Chief Justice John Roberts and Justice Antonin Scalia joined Justice Samuel Alito in a dissenting opinion.
Wyeth issued a written statement by its lawyer in the case, Bert Rein, a partner at Wiley Rein, Washington: We believed that federal law prohibited the company from revising its product label as the Vermont court required, and we regret that the Supreme Court disagreed.