FDA pre-emption case taken up by SCOTUS

The Supreme Court of the United States (SCOTUS) has agreed to hear a challenge by US drug major Wyeth against a $6.8-million award made to a Vermont woman who lost part of her arm due to gangrene after being injected with an antinausea drug, Phenergan (promethazine for injection). The appeal is the latest in a number of law suits the Supreme Court has agreed to hear in its next session, beginning April, concerning the pre-emption of Food and Drug Administration regulations in the prescription drug and medical devices markets. Two previously-reported cases involving respectively, Medtronic (Marketletter December 17, 2007) and Pfizer's Warner-Lambert unit (Marketletter October 8, 2007) are also awaiting a verdict.

The Wyeth case is due to be heard in April or October this year. According to the Wall Street Journal, the SCOTUS ignored the views of the US Solicitor General's office, which had argued the Wyeth case should be heard after the Medtronic and Pfizer law suits had been resolved. The appeal centers on the labeling information it provided for Phenergan. At issue in Wyeth versus Levine is whether the company can be sued under state product-liability laws over label information even though it met federal labeling requirements by the FDA.