"You Make Me Sick"

Supreme Court upholds state law suits vs. drug manufacturers for failure to warn

The U.S. Supreme Court today decided Wyeth v. Levine, holding 6-3 that a drug manufacture could be sued under Vermont products liability law for failure to give adequate warnings even though its drug label had been approved by the Food & Drug Administration.

Justice Stevens's majority opinion, joined by Justices Kennedy, Souter, Ginsburg, and Breyer, rejected the argument that federal law and the label approval preempted the suit brought under state law. Justice Thomas did not join the majority opinion but agree with it judgment; he wrote separately to question judicial invalidation of state law under "implied preemption" doctrine (as distinguished from cases where federal statutes expressly specify that they are preempting state law) based on nebulous "frustration" of federal purposes. Justice Alito, joined by Chief Justice Roberts and Justice Scalia, dissented, arguing that Supreme Court precedent and general principles of implied preemption forbade this suit under state law.

As a consequence of today's decision, states retain important freedom to protect their residents from harms flowing from inadequate warnings on pharmaceuticals.