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 American consumers to sue the manufacturer if they are harmed by a defective product.
The ruling affirmed a nearly $7-million jury verdict in favor of Diana Levine, a Vermont musician who had to have part of her right arm 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 -- a rejection of one of the Bush administration's most far-reaching legal policies -- applies to the more than 11,000 drugs on the market in the U.S., both over-the-counter and prescription medications.
Three years ago, the Bush administration switched long-standing Food and Drug Administration policy and announced that federal approval of a drug "preempts" 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 high 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 the manufacturers. 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 said.
Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Stephen 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 preemption issue. In December, the court cleared the way for smokers to sue the makers of "light" cigarettes for false advertising. That 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 in the drug case Wednesday.
"This case illustrates that tragic facts make bad law," Alito wrote. He called the result "a frontal assault on the FDA's regulatory regime for drug labeling."
Levine's case began nine years ago, when she went to a clinic near her home for treatment of a migraine. Besides a dose of Demerol to relieve the pain, she was given an injection of Phenergan for nausea.
What she did not know -- but the manufacturer knew full well -- was that the drug is extremely dangerous if it reaches an artery.
At least 20 other people had lost limbs this way.
Phenergan usually is administered orally or through an IV drip. Wyeth told doctors and nurses that they could administer Phenergan by injection but said that they must use extreme care when doing so.
Levine said the injection was painful, and apparently reached an artery. Gangrene soon developed. She lost first her hand and then part of her arm.
She sued and won a settlement from the clinic, and then sued Wyeth for failing to fully warn her of the dangers of injecting Phenergan. A Vermont jury agreed and awarded her $6.7 million in damages.
In its appeal, Wyeth said it had disclosed the risks to the FDA, which in turn had approved its warning label.
The Supreme Court took up the case of Wyeth vs. Levine to decide a far-reaching question of liability law in the pharmaceutical industry.
Had the court agreed that the FDA's approval shields the drug makers from lawsuits, the ruling likely would have ended tens of thousands of pending legal claims, industry experts said.
In a statement, the maker of Phenergan called the decision "disappointing, not only for Wyeth, for patients and public health in general. Patients are best served by a national standard for the labeling of prescription medication -- set by the medical and scientific experts" at the FDA.
Consumer advocates said they were delighted and relieved. Brian Wolfman, a lawyer for Public Citizen, said the FDA was overworked and understaffed.
"Once a drug is marketed to thousands of people, we learn of things that we never knew in the clinical trials," he said, adding that private lawsuits act as an extra safety check for consumers.