September 16, 2008
Lawyers defend failure-to-warn suit
Attorneys for a woman who lost an arm to gangrene after an IV administration of Wyeth's anti-nausea drug Phenergan say there is no conflict between a failure-to-warn suit under Vermont law and FDA's regulation of drug labeling.
In a brief to the US Supreme Court, the attorneys say that unlike the situation with medical devices, in which federal law contains a pre-emption provision, Wyeth is unable to demonstrate a clear congressional intent to have the FDA pre-empt state liability cases. The brief rejects the notion that it would be impossible for drug companies to comply with both state and federal law. “The Federal Food, Drug, and Cosmetics Act does not preclude drug manufacturers from adding or strengthening warnings or instructions regarding their products,” it said.
“Wyeth could have added a stronger warning against IV-push injection at the inception of its FDA approval process or after the drug was approved, through a labeling change.…Wyeth erroneously contends that it would be liable for misbranding or distributing an unauthorized new drug if it complied with the state-law duty to warn of IV-push risks. A drug is not misbranded if it contains true and accurate information about the risks associated with a particular method of administration. There is no credible claim that a court would have rejected a stronger warning or instruction regarding IV-push injection.”