Date: 10/6/2008 12:05 AM
Diana Levine, a musician from Vermont, won a $6.8 million judgment against drug maker Wyeth in state court after the injection of an anti-nausea drug led to the amputation of her arm. There is no dispute that the drug, which has been around for 50 years, is safe when administered properly or that there is a risk of gangrene if it is not.
The issue for the court is whether Wyeth could have issued stronger warnings about the risks without the approval of the Food and Drug Administration. The company says it would have needed FDA approval and that federal regulation leaves no role for the states. The Bush administration is on the company’s side.
But Levine, backed by 47 states, says that state laws complement federal regulation and that before Bush took office, the FDA thought so, too.
Copyright 2008 The Associated Press.
