The U.S. Supreme Court hears oral arguments today in the FDA drug labeling preemption case Wyeth v. Levine. The court will face the question whether pharmaceutical manufacturers can be held liable for insufficient warnings on drug labels despite FDA approval of the labels’ language.
The plaintiff Diana Levine, a musician, lost her arm because a hospital administered the drug by IV push, rather than by an intramuscular injection or IV drip. She alleges that the product’s label failed to adequately warn that the IV-push method posed a danger of gangrene.
Drug industry groups are seeking refuge from state court lawsuits by a ruling that the FDA approval of the label precludes such suits. The implications are huge for consumers. The FDA has insufficient staff and insufficient funds to police the drug industry, and depends on the manufacturers’ own studies when making its decisions about drug approval. Even key FDA officials opposed the Bush Administration’s preemption regulations because they rest on the false premise that the agency’s drug approval process can ensure accurate and up-to-date drug labels.
Without the deterrence of liability to injured consumers, there is far less incentive to be cautious when releasing new drugs to the market. It would be tragic if patients who have been injured or killed by use of dangerous drugs such as Vioxx, Fen-phen, and Ketek were deprived of a day in court when the FDA’s surveillance system does little to protect them and nothing to compensate them.