Supreme Court considers the reach of drug warning labels
The justices sound closely split as they hear arguments on whether product liability lawsuits should be allowed if a federal agency such as the FDA regulates the product.
Reporting from Washington — The Supreme Court justices sounded closely split today on whether to shield drug makers from being sued if they fail to warn patients and doctors of all the risks of a prescription drug.
The justices heard the case of Diana Levine, a Vermont woman whose arm was amputated after she was injected with an anti-nausea drug. The injection struck an artery and caused gangrene.
Her lawyer called this a "catastrophic" and well-known risk of injecting Phenergan, a drug made by Wyeth. She sued the drug maker and won $6.7 million before a Vermont jury, which agreed the drug maker should have warned doctors and nurses against injecting this drug under any circumstances.
But lawyers for Bush administration lawyer and for Wyeth urged the high court to throw out her lawsuit and others like it because the Food and Drug Administration had approved a warning label for the drug that merely urged physicians to be cautious when injecting the drug.
The case could have a wide impact on drugs and the rights of consumers. The Bush administration has argued that if a federal agency such as the FDA regulates a product, injured consumers should not be allowed to sue and to seek damages because the product is dangerous and defective.
But for most of the hourlong argument, the justices struggled to understand whether the FDA had or had not weighed whether Phenergan could be safely injected.
"How could the FDA conclude it was safe and effective?," asked Justice Samuel A. Alito Jr. Who would take an anti-nausea drug if there was a risk of losing your arm to gangrene, he wondered.
"The FDA was aware of the risks" of injecting this drug, replied Washington lawyer Seth Waxman, representing Wyeth. Injecting the drug gives quick relief to patients, he said, and the agency decided against adding stronger warning to the drug's label.
A lawyer for Levine disputed the contention that the FDA was fully aware of the risks of this drug when it was injected.
"A reasonably prudent manufacturer" who knew that patients had suffered amputations would have warned against ever injecting this drug, said Washington lawyer David Frederick. The warning label "is not set in stone," he added, and Wyeth could have added stronger cautions.
Justice Ruth Bader Ginsburg appeared to agree with Frederick. She noted that 11,000 drugs are on the market. "Is the FDA really monitoring all those drugs?," she asked. The plaintiffs' lawyers argue that lawsuits alert patients and doctors to newly emerging risk of drugs that are on the market.
But Justices Antonin Scalia and Chief Justice John G. Roberts Jr. questioned whether drug makers can be held liable if they alerted the FDA to these risks, but no change in the warning label was ordered.
The case, Wyeth vs. Levine, has been seen as a test of the outgoing Bush administration's view that consumer lawsuits can be blocked if the products are regulated by federal agencies.
Savage is a Times staff writer.
David.savage@latimes.com
