The Supreme Court today ruled in favor of a woman who had her arm amputated after an improper injection of an antinausea drug and said drugmakers could not rely on federal regulation to protect them from lawsuits brought under state consumer protection laws.
The court ruled 6-3 that Congress did not mean to shelter drugmakers such as Wyeth Pharmaceuticals from the kind of lawsuits brought by Diana Levine of Vermont, who developed gangrene after a physician's assistant injected the drug Phenergan into a vein.
The opinion by Justice John Paul Stevens said that even though the Food and Drug Administration had approved label warnings about complications from the drug, the company could have done more to prevent what happened to Levine, a children's musician who played guitar.
Wyeth contends that "once the FDA has approved a drug's label, a state-law verdict may not deem the label inadequate, regardless of whether there is any evidence that the FDA has considered the stronger warning at issue," Stevens wrote. "The most glaring problem with this argument is that all evidence of Congress' purposes is to the contrary."
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