The Supreme Court enhanced the ability of injured patients to hold drugmakers responsible Wednesday, in a 6-3 decision that affirmed a jury award for a woman who lost an arm to gangrene after injection of an anti-nausea drug.
The broadly written decision sends a strong signal to lower court judges to let state liability lawsuits go forward even when the federal government regulates the area. The court rejected arguments by the Bush administration last year and drug manufacturer Wyeth that federal law overrides certain state claims.
Lawyers on both sides of the issue deemed the ruling significant, although it is not clear how widely it will apply beyond certain drug cases.
"The message here is that consumers will get their day in court," said lawyer David Frederick, who represented Diana Levine, a former guitarist who lost her arm after she had gone to a health clinic in April 2000 for treatment of a migraine. A clinician injected Wyeth's Phenergan drug directly into a vein, allowing the drug to reach an artery. It caused immediate gangrene.
A jury found that Wyeth's label had inadequate warnings about the dangers of the IV-push method used; Levine won $6.7 million. (She settled a separate case with the health center and clinician.)
The Vermont Supreme Court upheld the verdict and rejected Wyeth's arguments that Levine's state failure-to-warn claims should have been thrown out because the Food and Drug Administration had approved the label.
Levine, 63, said her knees buckled when she heard she won at the high court. "I was hanging on and crying for dear life," said Levine, who runs a small record company. "If I had lost, the rights of people to tell their story in court if they were hurt by a drug unnecessarily would have been taken away."
Wyeth had argued that it could not change the label after the FDA approved it. The company said allowing suits based on the liability laws of 50 states would thwart U.S. regulatory goals.
Bert Rein, representing Wyeth, said Wednesday FDA medical experts can best decide what a label should say.
Justice John Paul Stevens wrote for the majority that Congress had not displaced state law. He rejected the FDA's "recently adopted position" that state suits interfere with its regulation.
Dissenting justices noted Levine's loss even as they insisted that the majority broke from court precedent. "This case illustrates that tragic facts make bad law," Justice Samuel Alito wrote, joined by Chief Justice John Roberts and Justice Antonin Scalia.
Tom Dewey, a New York lawyer who has represented the drug industry, said the decision will make it harder for companies to win quick dismissal of cases in the states. "This was one of the threshold defenses," he said. "If the FDA signed off on the label, they were done."
Appleby reported from McLean, Va.