Ruling deals defeat to drug makers
Regulation not a shield against lawsuits
WASHINGTON – The Supreme Court dealt a defeat to the pharmaceutical industry and the Bush administration Wednesday, 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.
The ruling affirms a nearly $7 million jury verdict in favor of Diana Levine, 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 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 in the United States, 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 that 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 that 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 drug maker Wyeth and urged the court to adopt the policy as federal law.
But Justice John Paul Stevens, speaking for the court, said the administration’s view “does not merit deference.”
Congress has passed laws regulating drugs for a century, he said, yet lawmakers have never barred consumers from suing drug makers. And for good reason, Stevens added. Lawsuits not only compensate injured individuals, but they “uncover drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly,” he wrote.
Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Steven G. Breyer agreed. Justice Clarence Thomas concurred in the result. Thomas has been wary of the notion that federal regulations trump state law.
It was the second defeat for manufacturers in this term on a pre-emption issue. In December, the court cleared the way for smokers to sue the makers of “light” cigarettes for false advertising. The 5-4 ruling rejected the industry’s claim that the federal cigarette warning label barred such suits.
Chief Justice John G. Roberts Jr. and Justices Antonin Scalia and Samuel A. Alito Jr. dissented on Wednesday.