In a recent 6-3 decision, the United States Supreme Court rejected claims by drug manufacturing firms that FDA approved warning labels on drugs pre-empted state lawsuits based on failure to give adequate warning of the drug’s risks. In this case, Wyeth Pharmaceuticals v. Levine, a Vermont jury had awarded several million dollars to a patient whose right arm had to be amputated after she received an IV push injection of the drug, Phenergan. The lawsuit claimed Wyeth failed to provide appropriate warning of the drug’s risks associated with improper administration. Wyeth argued that, even though it could have changed the label warnings without FDA approval, the FDA’s approval of the original warnings essentially gave Wyeth immunity from lawsuits.
This immunity argument was flatly rejected by the Supreme Court which noted that Congress had never passed any legislation granting immunity to drug manufacturers for faulty warnings which may have been approved years ago by the FDA based on the data provided to the agency by the drug manufacturer. Clearly, if the FDA got bad information from the drug companies, it would not be able to issue proper label warnings.
This case is an important victory for patients. It makes little sense to give drug companies immunity from lawsuits when they give bad or incomplete information to the FDA. It is in everyone’s best interest to make sure drug manufacturers regularly update label warnings based on the most recent information they have regarding drug risks. Our firm has handled many cases where patients have suffered serious injuries, including development of Reflex Sympathetic Dystrophy (RSD), from improper administration of Phenergan. If you believe you have had a serious injury resulting from a reaction to a drug you have received, please call us for a free consultation.