Supreme Court Rejects Preemption Argument by Drug Makers

The United States Supreme Court rejected arguments that federal regulation preempted state lawsuits against drug makers. In the case of Wyeth v. Levine, the injured plaintiff Diane Levine, had her arm amputated after she was injected with Phenergan, made by Wyeth. Wyeth argued that federal approval of the Phenergan and its warning label protected the company from lawsuits. The case is seen as a surprise given that the Bush administration had argued that once a drug's warning label is approved by the FDA, consumers cannot pursue state law claims if they are injured by the drug. Justice Stevens, who wrote the majority opinion, said that Wyeth could "unilaterally strengthen its warning", especially after if learned of at least 20 other incidents prior to Mrs. Levine's injury. The FDA is charged with monitoring 11,000 drugs!!!

This outcome was shocking to many given the fact that the Supreme Court had earlier held that suits against medical device makers were preempted, in the case of Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). In Riegel, the Supreme Court held that makers of medical devices were immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it met the agency's specifications.

I agree with the Wyeth decision. The FDA is overworked and underfunded. As recognized, in the opinion, state court lawsuits provide a valuable service of uncovering problems with drugs and a "complementary form of drug regulation". With over 11,000 drugs, the FDA simply cannot be expected to catch and/or solve all problems. Without the ability to file suit, the consumer is left unprotected.