Supreme Court rules against preemption

The U.S. Supreme Court ruled 6-3 Wednesday that an FDA-approved label for Phenergan promethazine from Wyeth (NYSE:WYE) did not preempt state tort law in a product liability suit. In Wyeth v. Levine, the majority concluded that it would not be impossible for the company to comply with both federal and state law obligations and that Levine's common-law claims were not an obstacle to the fulfillment of Congress' purposes in the Food, Drug and Cosmetic Act (FDCA). "Although we recognize that some state-law claims might well frustrate the achievement of congressional objectives, this is not such a case," according to the majority's opinion, which was written by Justice John Paul Stevens.

Diana Levine had her forearm amputated in 2000 after contracting gangrene following an IV push injection of Phenergan for nausea associated with migraine. Her attorneys argued that Wyeth failed under state law to provide adequate warning about the risks of administering Phenergan with the IV push method. At the time of Levine's treatment, Phenergan's label warned that inadvertent intra-arterial administration of the drug could lead to gangrene and amputation (See BioCentury, Nov. 10, 2008). ...