This site is intended for health professionals only

Medical suit challenges federal law


A woman who lost her arm to gangrene after an injection, and is suing a pharmaceutical company over drug labelling, is pitting US state law against the federal government.

Diana Levine sued Phenergan manufacturer Wyeth in a state court in Vermont over alleged problems with the label, and a jury ruled in her favour.

But in an appeal to the supreme court, Wyeth argues that Food and Drug Administration (FDA) approval of medication labels precludes lawsuits in state courts.

Levine received an injection of the nausea medication into an artery during a push IV injection, which is more potent and takes less time to act than a traditional injection.

According to the New York Times, the case “is perhaps the most significant case of the term”. It refers to a court ruling that FDA approval of certain medical devices protects manufacturers from product-liability lawsuits filed in state courts.

But Erwin Chemerinsky, a dean at the University of California-Irvine School of Law, said that a decision in favour of Wyeth would “make it extremely difficult, if not impossible, for people injured by pharmaceutical drugs to be able to sue”.

Copyright PA Business 2008

Be in the know
Subscribe to Hospital Pharmacy Europe newsletter and magazine