WASHINGTON, March 4 (UPI) -- The U.S. Supreme Court ruled 6-3 Wednesday across ideological lines that federal law doesn't pre-empt state lawsuits for inadequate drug label warnings.
The Bush administration had argued that the relatively mild federal law prevents such actions under tougher state laws and critics immediately said the decision would open the "floodgates" to a new round of drug label lawsuits.
The case began when Diana Levine sought medical help for migraines. A Vermont clinic used injections of the anti-nausea drug Phenergan, which the U.S. Food and Drug Administration approved in 1955. But if the corrosive drug enters an artery it can cause gangrene.
Levine, a guitarist, eventually lost an arm to gangrene. She sued drug-maker Wyeth because its label didn't advise clinicians to use the "IV drip" method of injecting the drug, rather than the "IV push" method actually used. A Vermont jury awarded her $6.7 million, which was upheld by the Vermont Supreme Court.
Wednesday, an opinion written by Justice John Paul Stevens upheld the state court ruling. Stevens said Congress, in enacting the Food, Drug, and Cosmetic Act, clearly never meant to pre-empt state law and that FDA regulations make the manufacturer responsible for label content.
Stevens was joined by the three other members of the liberal bloc and swing vote Justice Anthony Kennedy. Conservative Justice Clarence Thomas concurred in the judgment in a separate opinion, saying the Bush administration's "sweeping approach to pre-emption leads to the illegitimate -- and thus, unconstitutional -- invalidation of state laws."
One tort reform group, the New Jersey Lawsuit Reform Alliance, slammed the decision. "The ruling is certain to open the floodgates to new lawsuits around the country," group Executive Director Marcus Raynor said.
But Nan Aron, president of the consumer advocate group Alliance for Justice, said in a statement, "The six justices who stood up for accountability sent a clear message that FDA approval does not necessarily grant a corporation a license to hit and run."
