The Supreme Court today upheld a $6.7 million award for a Vermont woman who sued drug giant Wyeth when she lost an arm to gangrene after receiving a shot of anti-nausea medicine to treat a migraine headache.
The woman, Diana Levine, sued Wyeth in a Vermont court under a "fail to warn" law charging that the company failed to adequately warn of the risks of administering the drug, Phenergan, through an IV procedure.
Wyeth argued that federal law protects the company from such state lawsuits. The company said that the Food and Drug Administration approved the drug's label and was aware of the known risk associated with some forms of intravenous injection, which cause the drug to begin working more quickly.
Justice John Paul Stevens, writing for the majority, said, "Wyeth has not persuaded us that failure to warn claims like Levine's obstruct 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."
Levine, who was a musician before losing her arm, argued that Wyeth should be held accountable.
"They did not minimize the risk," she said in an interview before today's decision. "They could have completely eliminated the risk by saying under no circumstances give this anti-nausea drug by means of an IV push. If they had done that I would still have my arm. I would still be doing music, play electric bass, playing guitar, writing songs and using the piano. I can't do that anymore."
The case has been closely watched because the court in recent years has shown a willingness to limit lawsuits against makers of medical devices, ruling that the federal law pre-empted those claims. Wyeth had pushed those arguments a step further, arguing that Levine could not sue because it had complied with the FDA on its labeling. Lower courts rejected Wyeth's argument, and the Supreme Court agreed.
An attorney for Wyeth, Bert Rein, said the company believed the FDA is in the best position to weigh the risks and benefits of a medicine and set the standard for the product's label.
"Wyeth fully complied with federal law in its labeling of Phenergan, which provided clear instructions and warnings about its use," Rein said in a statement after the decision. "We believed that federal law prohibited the company from revising its product label as the Vermont court required, and we regret that the Supreme Court disagreed."
Business Community Watching Closely
The case did not split completely along ideological lines: Justice Clarence Thomas joined with the more liberal justices and Justice Anthony Kennedy to rule for Levine. Justice Samuel Alito dissented, joined by Chief Justice John Roberts and Justice Antonin Scalia.
Alito wrote, "This case illustrates that tragic facts made bad law. … the FDA has the benefit of the long view. Its drug-approval determinations consider the interests of all potential users of a drug, including 'those who would suffer without new medical [products]' if juries in all 50 States were free to contradict the FDA's expert determinations."
Before today's decision, Rein said the company was unable to modify the label without FDA authorization.
"If [Wyeth] had used anything else, it would have been committing a federal felony crime," he said. "A state should not be able to tell Wyeth to go ahead and violate federal law."
Rein had warned a loss in the case would be "undermining the professional judgment of the FDA and substituting judgments made in the context of injuries by juries who don't have the skills, don't have the training, and don't have the overall perspective of the experts at the FDA."
The business community was also watching today's case closely, well aware that it could affect other cases against big drug makers like Eli Lilly and Co., GlaxoSmithKline and Pfizer Inc., not to mention other industries such as food, highway safety and domestic security.
Wyeth is in the process of being acquired by Pfizer in a proposed $68 billion deal.