The Supreme Court on Wednesday enhanced the ability of people to hold drug companies financially responsible for injuries. In a 6-3 decision, the court ruled that federal law does not block a lawsuit in state court by a woman who lost an arm to gangrene after receiving an injection of an anti-nausea drug.
The ruling, a rejection of the Bush administration's position, affirms a Vermont jury's $6.7 million award to Diana Levine, a former guitarist, who sued drugmaker Wyeth for the loss of her arm after she had gone to a local health clinic in April 2000 for treatment of a migraine. A physician's assistant injected Wyeth's anti-nausea drug Phenergan into an artery, rather than a vein, and caused immediate gangrene.
In her lawsuit, Levine had claimed the Phenergan drug label should have better warned about the potential dangerous side effects of the so-called IV-push method of injection used. The Vermont Supreme Court upheld the jury verdict and rejected Wyeth's arguments that her failure-to-warn claims should have been thrown out because the label had been approved the U.S. Food and Drug Administration (FDA).
Affirming that decision Wednesday, the justices said the Federal Drug Act, under which the FDA operates, does not eliminate state law protections in the area.
Justice John Paul Stevens, writing for five of the justices in the majority, said: "Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling. Congress has repeatedly declined to pre-empt state law, and the FDA's recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight."
The case had drawn wide interest from states and consumer groups, on Levine's side, and the drug industry and businesses, for Wyeth. The overriding question was when federal regulation of a field — here, the FDA and drug labels — prevents a person from bringing a state-law product liability claim. The Bush administration, in a move that broke from past administrations on the issue, had joined with Wyeth to try to curtail state remedies for personal injuries.
Levine's lawyers had contended that patients injured by prescription drugs have long been able to bring state-law failure-to-warn claims against drug makers, and that until the Bush administration changed policy in 2002, the FDA had regarded such state claims as a complement to federal regulatory efforts.
Justice Clarence Thomas concurred in the majority's judgment that federal law does not prevent the state lawsuit but used a different legal approach. Dissenting were Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alito.
"This case illustrates that tragic facts make bad law," Alito wrote for that trio. "The court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs." Alito said that cannot be squared with the court's past decisions that have tended to curb such state liability cases.