The US Supreme Court has just ruled in favor of a woman who was severely injured by a defective drug. The case had been closely watched by big pharma as well as consumer justice attorneys for quite some time. The case had far reaching implications because Wyeth Pharmaceuticals had argued that those hurt by dangerous drugs should not be allowed to sue drug manufactuers if the FDA had already approved the drug in question. The legal issue concerned pre-emption and was rejected in a 6-3 Supreme Court vote. Justice John Paul Stevens, in writing the majority opinion, stated the lawsuit before the Justices, “The question we must decide is whether the FDA’s approvals provide Wyeth with a complete defense to Levine’s tort claims. We conclude that they do not. . . In short, Wyeth has not persuaded us that failure-to-warn claims like Levine’s obstruct the federal regulation of drug labeling. Congress has repeatedly declined to preempt state law, and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight. Although we recognize that some state law claims might well frustrate the achievement of congressional objectives, this is not such a case.”
This is a significant victory for all those concerned with consumer safety, especially in the wake of the FDA’s recent history of errors concerning drugs and medical devices. It is also an important victory for state’s rights and their role in promoting and safeguarding consumer safety.