Supreme Court Rules against Drug Manufacturer in Product Liability Case

On March 4, 2009, in a much anticipated ruling, the United States Supreme Court ruled against the pharmaceutical company, Wyeth, in the case Wyeth v. Levine. The Supreme Court held that a Vermont woman was not prohibited from bringing a state law tort claim against the drug manufacturer over the labeling of one of their products, Phenergan.

In a 6-3 opinion authored by Justice Stevens, the High Court ruled that the U.S. Food and Drug Administration ("FDA") labeling approvals do not pre-empt state laws or shield companies from liability claims. Wyeth had argued that it believed federal law prohibited it from revising the information about the dangers of administering Phenergan the way that Diana Levine had received it because it would be impossible for Wyeth to comply with both state-law and federal labeling requirements. Ms. Levine, a guitarist, lost part of her arm to amputation after she was improperly administered Phenergan and developed gangrene.

The Court stated that under FDA regulations, the burden of accurate warning labels falls to the drug manufacturer. The statutory language of the Food, Drug and Cosmetic Act ("FDCA") demonstrates that Congress did not intend to pre-empt state law failure-to-warn actions.