WASHINGTON - The U.S. Supreme Court on Wednesday rejected an appeal by Wyeth Pharmaceuticals in a closely watched federal preemption case, ruling that a woman may sue in state court over a federally-approved drug.
The Collegeville, Pa.-based drug company was seeking to reverse a $6.7 million jury award in a case brought by a Vermont woman whose forearm was amputated because of a reaction to an injected anti-nausea drug, Phenergan.
The plaintiff, Diana Levine, lost an arm to gangrene after an injection of the drug Phenergan.
The drug causes gangrene if it comes in contact with arterial blood, so the medication is typically given by intramuscular injection or intravenously. Levine says that method of using the drug wasn't safe under Vermont state law.
A jury awarded her more than $6 million to Levine because Wyeth failed to warn her adequately about the risks of the drug. Wyeth, however, says her claims are preempted by the U.S. Food, Drug and Cosmetic Act.
Writing for the court's 6-3 majority, Justice John Paul Stevens said the U.S. Food and Drug Administration's oversight of drug labeling doesn't prevent state-level actions against drug companies.
"In short, Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling," Stevens wrote.
"Congress has repeatedly declined to preempt state law, and the FDA's recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight," the opinion also said.
One of the nation's leading tort reform advocates, James Copland of the Manhattan Institute, called the decision disappointing because the ruling allows a state jury to override the FDA's "carefully considered judgments" when approving a medication.
"The decision has vast negative implications, for both the economy and public health," Copland said in a statement.
In a brief to the high court, the Product Liability Advisory Council Inc. said if the decision was allowed to stand, manufactures would be forced to choose between following state laws or federal law.
"If they decide to comply with federal law, they will-like petitioner in this case-be exposed to multimillion dollar state-law tort liability," the brief said. "No company should be forced to make that choice or to suffer those consequences."
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