FDAnews Drug Daily Bulletin

The U.S. Supreme Court will hear a second drug preemption case to decide whether the FDA’s authority to regulate labeling of a Wyeth drug preempts Vermont state law for product liability.

The court granted Wyeth’s request for writ of certiorari for Wyeth v. Levine. The company filed the request after the Vermont Supreme Court awarded $6.8 million to Diana Levine, a professional musician who received Wyeth’s antinausea drug Phenergan (promethazine) in a hospital during treatment for a migraine headache.

The drug was mistakenly injected into an artery, causing injuries that “quickly and irreversibly” led to the amputation of her right arm, according to the Public Citizen Litigation Group, Levine’s co-counsel.

Public Citizen said the court should deny review because Levine’s claim was not preempted by FDA drug labeling regulations and there is no conflict among appellate courts.

For Wyeth v. Levine, the petitioner’s brief is due Feb. 25, and the respondent’s brief is due March 24.