WASHINGTON — On the day before the nation elects a new president, the Supreme Court debated an important legal legacy of the outgoing Bush administration.
Two years ago, the administration said drug makers should be shielded from being sued by injured patients if federal regulators had approved warning labels that weigh the risks of a prescription drug.
Until then, consumers in most states could sue if they were hurt by a dangerous product, even if it had been approved by the federal government.
The justices appeared to be closely split Monday on whether to uphold or reject the administration's approach. The court heard arguments in the case of Diana Levine, a Vermont musician whose arm was amputated after she was injected by an IV push with an anti-nausea drug. The injection struck an artery and caused gangrene.
Her attorney called this a catastrophic and well-known risk of injecting Phenergan, a drug made by Wyeth. She sued the drug maker in a Vermont court and said doctors and nurses should have been warned against injecting Phenergan under any circumstances. A jury agreed and awarded her $6.7 million in damages.
At issue in the Supreme Court is whether the federal Food, Drug and Cosmetic Act blocks state lawsuits that conflict with federal drug regulations.
On Monday, attorneys for the Bush administration and for Wyeth urged the high court to throw out her suit 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.
They said the approved warning label acts as a shield against suits. "The FDA was aware of all the forms of administration [of Phenergan] and the risk," said Washington lawyer Seth Waxman, for Wyeth.
Several justices questioned whether the FDA truly weighed the risks.
"How could the FDA conclude the IV push was safe and effective?" asked Justice Samuel A. Alito Jr. "On the benefit side . . . you have a drug that relieves nausea, and on the risk side, you have the risk of gangrene."
But Justice Antonin Scalia and Chief Justice John G. Roberts Jr. appeared to be on the side of the drug makers. They 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 labeling says it is dangerous to use an IV push," Scalia said.
