A Victory in the Fight Against Federal Preemption
MARCH 4, 2009
By MARK H. ANDERSON and BRENT KENDALL
WASHINGTON -- In a loss for the pharmaceutical industry, the Supreme Court ruled 6-3 Wednesday that a Vermont woman can sue Wyeth for injuries she suffered after taking one of the drug maker's medicines.
Justice John Paul Stevens, in the court's majority opinion, said Food and Drug Administration oversight of drug labeling doesn't prevent the filing of state-level consumer liability lawsuits against drug companies.
""In short,"" Justice Stevens wrote, ""Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling.""
Justice Stevens 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.
The ruling affirms an opinion by the Vermont Supreme Court.
At issue was a lawsuit by Vermont guitarist Diana Levine, who lost an arm to gangrene after Wyeth's antinausea drug Phenergan was inadvertently injected into one of her arteries during a push IV injection. Ms. Levine had gone to a clinic for treatment of a migraine headache.
Ms. Levine argued that Phenergan's labeling, though approved by the Food and Drug Administration, didn't 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. The Vermont Supreme Court upheld the award, ruling that FDA drug regulations don't prevent a company from being sued under state law over drug labeling.
Wyeth argued that Ms. Levine's lawsuit, which was based on Vermont law, should be preempted by federal drug regulations. The FDA, Wyeth said, knew of the drug's risks and benefits and instructed the drug maker to use labeling that accommodated both. Wyeth said it wasn't free to change the warnings on the label.
Joining Justice Stevens in the majority were justices Anthony Kennedy, David Souter, Ruth Bader Ginsburg, Stephen Breyer and Clarence Thomas. Although Justice Thomas concurred with the outcome, he did so under a different line of legal reasoning. Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alito dissented.
""This case illustrates that tragic facts make bad law,'' Justice Alito said. ""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.""
The case is Wyeth v. Levine