This morning, the Supreme Court released its much anticipated decision in Wyeth v. Levine. The case centered on the ability of consumers to sue corporations in state court for injuries caused by their products and was arguably the most important consumer rights case of the Court’s term. By a margin of 6 to 3, the Court sided with Diana Levine, stating that the Food and Drug Administration’s approval of Wyeth’s drug label did not explicitly preempt Diana’s ability to file suit.
Wyeth had put forward the argument, used successfully by Medtronic last year in Riegel v. Medtronic, that once the FDA approves a product, the federal agency’s authority supersedes state tort law, and thus, corporations are immune from liability for harm done by their products. If successful, this “hit and run” interpretation of the law would have let corporations escape accountability for the safety of their products and left millions of injured Americans without recourse.
Writing for the majority, Justice John Paul Stevens explained that “Wyeth has not persuaded us that failure-to-warn claims like Levine’s obstruct the federal regulation of drug labeling.” Justice Stevens went on to write that “Congress has repeatedly declined to preempt state law” and recent changes made by the Bush administration to FDA policy arguing “state tort suits interfere with its statutory mandate is entitled to no weight.” Justices Stephen Breyer, Ruth Bader Ginsburg, David Souter and Anthony Kennedy signed on to his opinion. Justice Clarence Thomas wrote a concurrence, agreeing with the majority’s outcome, but taking issue with their reasoning.
In a statement, Alliance for Justice President Nan Aron said “Today’s victory for Diana Levine is really a victory for all American consumers. The Supreme Court rejected the premise that drug manufacturers who fail to warn consumers of the dangers associated with their products can evade responsibility for the harm they do to Americans. The six justices who stood up for accountability sent a clear message that FDA approval does not necessarily grant a corporation a license to hit and run.”