Supreme Court Accepts Drug Labeling Pre-Emption Case
The U.S. Supreme Court will consider whether a woman whose arm had to amputated after she was injected with an anti-nausea drug can sue based on a state law claim that tougher warnings were needed than those approved by the federal government.
The plaintiff in the case, Diana Levine, was awarded $6.8 million against Wyeth, whose anti-nausea drug Phenergan was mistakenly injected into the woman’s artery, causing her to lose part of her arm, the Associated Press reports.
Wyeth claims in its cert petition (PDF posted by SCOTUSblog) that its warning label was sufficient because it had been approved by the Food and Drug Administration. The Vermont Supreme Court sided with Levine, saying the FDA requirements are a floor rather than a ceiling for state regulation.
The case is the third accepted this term to deal with state lawsuits and FDA regulation of pharmaceuticals and medical devices, Dow Jones reports.
