LOS ANGELES TIMES
March 5, 2009
WASHINGTON - The Supreme Court dealt a defeat to the pharmaceutical industry yesterday, ruling that federal approval of a prescription drug does not provide a shield against lawsuits from injured patients.
The 6-3 decision upholds the traditional right of U.S. consumers to sue the manufacturer if they are harmed by a defective product and affirms a nearly $7 million jury verdict in favor of Diana Levine, 63, a Vermont musician whose right arm was amputated after she was injected with an anti-nausea drug.
"Next to getting my hand back, this is the best thing they can do," Levine said by phone of the justices' decision. "I feel like something worthwhile has come out of a tragedy." The ruling applies to the more than 11,000 drugs on the market nationally, including over-the-counter as well as prescription drugs.
It also gives a thumbs-down verdict to one of the Bush administration's most far-reaching legal policies. Its lawyers maintained federal regulation of a product generally should bar juries from deciding whether the same product is defective.
Three years ago, the Bush administration switched long-standing Food and Drug Administration policy and announced federal approval of a drug "pre-empts" or bars suits in state courts. Last fall, the administration's lawyers joined the Levine case on the side of drugmaker Wyeth and urged the court to adopt the policy as federal law.
But Justice John Paul Stevens, speaking for the court, said that view "does not merit deference." Congress has passed laws regulating drugs for a century, he said, yet lawmakers have never barred consumers from suing drugmakers.
And for good reason, Stevens added. Lawsuits not only compensate injured individuals, but "uncover drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly," he wrote.