March 5, 2009
Consumers now have greater standing to sue drug companies when drugs kill or cause severe injuries. The U.S. Supreme Court ruled 6-3 that federal law does not prevent plaintiffs from suing drug companies in state court.
The case involved a musician whose arm was amputated after gangrene resulted from an improper injection with an anti-nausea drug. The ruling upheld a Vermont jurys $6.7 million award to Diana Levine, who played guitar until the amputation.
Levine received an injection of Wyeths Phenergan when she went to a local health clinic in 2000. The physicians assistant injected the drug into an artery instead of a vein, causing the gangrene.
Public Citizen attorney Brian Wolfman, one of the attorneys who represented Levine, said the decision was "gratifying." He called the decision "a huge victory for Diana, for patients across the country and for public health."
"There are real people involved here," Wolfman said. "Levine lost her arm because Wyeth did not take a simple step to warn her doctors of an avoidable risk of gangrene that was well known to the company — that its anti-nausea drug should not have been administered via the IV-push method."
Why not sue the clinic instead of the drug company?
Levine argued that the Phenergan drug label should have carried a clearer warning about the potential dangerous side effects of the so-called IV-push method of injection. The Vermont Supreme Court and U.S. Supreme Court rejected Wyeths argument they should not be held liable since the label had been approved by the U.S. Food and Drug Administration.
Writing for the majority, Justice John Paul Stevens 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."
In his dissenting opinion, Justice Samuel Alito said that the ruling ultimately means state court juries will be responsible for regulating warning labels, instead of the FDA.
