In a surprise decision, the Supreme Court ruled 6-3 today that Vermont resident, Diana Levine, can sue Wyeth for injuries she suffered after she was administered one of the company's FDA-approved drugs.
Justice John Paul Stevens, in the court's majority opinion, said that FDA oversight of drug labeling does not prevent the filing of state-level consumer liability lawsuits against drug companies, the Wall Street Journal (WSJ) reported.
"In short," Stevens wrote, "Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling." He added that "Congress has repeatedly declined to preempt state law" and that recent Bush administration changes to FDA policy claiming "that state tort suits interfere with its statutory mandate is entitled to no weight" in the Wyeth case.
Today's ruling affirms a decision by the Vermont Supreme Court.
On Nov. 3, the court heard Wyeth v. Levine to decide if federal law displaces all product liability claims brought against all makers of prescription drugs—their decision will affect every drug maker in all 50 states. Many entities posited their opinions on the matter—including New England Journal Medcine editors who filed an amicus brief in defense of consumers. However, such petitions have not always influenced the court.
Levine lost an arm to gangrene after Wyeth's anti-nausea drug Phenergan was injected into one of her arteries during a push IV injection for the treatment of a migraine.
Levine argued that Phenergan's labeling, though FDA-approved, did not provide proper warnings of the risk of administering the drug through a push IV injection instead of using an IV-drip. A Vermont jury awarded her $6.7 million in damages, which the Vermont Supreme Court upheld, ruling that FDA drug regulations do not prevent a company from being sued under state law over drug labeling.
Today's ruling could potentially have more far-reaching impact on the industry than last year's pre-emption case, Riegel v. Medtronic, in which the Supreme Court ruled federal medical device regulations trump state product-liability lawsuits unless the medical device company violated FDA policy, protecting companies from lawsuits on the FDA-approved devices. However, Riegel only affected PMA-approved medical devices, which equates to about 50 devices annually.
Justices Anthony Kennedy, David Souter, Ruth Bader Ginsburg, Stephen Breyer and Clarence Thomas joined Stevens in the majority, the WSJ reported. Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alito dissented.
"This case illustrates that tragic facts make bad law," Alito said. "The court holds that a state tort jury, rather than the FDA, is ultimately responsible for regulating warning labels for prescription drugs."