Supreme Court Evaluates Effects of FDA Drug Labels on Liability Cases

By Aaron Poehler

Published on November 05, 2008

The U.S. Supreme Court is currently hearing arguments in a case which could result in significant restrictions on lawsuits against drug manufacturers if the justices decide FDA approval conveys protection from liability claims.

The case, Wyeth v. Levine, No. 06-1249, involves Vermont guitarist Diana Levine, who lost part of her right arm due to an improperly administered dosage of an anti-nausea drug called Phenergan, manufactured by Wyeth. A Vermont court awarded Levine nearly $7 million from Wyeth, saying the manufacturer should have placed stronger warnings on the drug's label.

Lawyers for Wyeth argue that the company fully complied with U.S. Food and Drug Administration labeling requirements. At issue in the case is whether pharmaceutical companies should be liable for injuries caused by drugs which carry warnings approved by the FDA. However, the case may have implications far beyond drug liability cases due to the court's assessment of the implied doctrine of pre-emption based on federal approval. Should the court broadly endorse implied pre-emption based on regulators' actions rather than on Congressionally-enacted laws, the decision could affect thousands of currently pending personal injury lawsuits, including those involving not only drugs but also motor vehicles, consumer products, and household chemicals.

A decision in the case is expected by the end of June.

 

Comment on this article →