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.
Disagreeing, an attorney for Levine said the warning label fell short of protecting patients. A “reasonably prudent manufacturer” who learned patients had suffered amputations would have warned against ever injecting this drug, Washington lawyer David Frederick said. The warning label “is not set in stone,” he added, and Wyeth could have added stronger cautions.
The case of Wyeth vs. Levine could have a wide effect on drugs, the pharmaceutical industry and the rights of consumers. It tests the Bush administration’s policy of “preemption,” which holds that if a federal agency has approved a product for the market, injured consumers generally cannot sue and seek damages by asserting the product is dangerous and defective.
In the past, the justices have upheld this approach for some products, but only when a federal agency sets tight standards for a product.
For example, the court barred suits from injured motorists who claimed their older cars were defective because they lacked air bags. The court said federal regulators set a schedule for automakers to add air bags to new cars.
In the drug case, both sides agreed that Congress did not, by passing the FDA law, seek to block lawsuits from persons injured by prescription drugs. But Wyeth and the Bush administration argued that drug suits should be blocked when there is a conflict between the FDA’s decision that a drug is safe and a jury’s verdict calling it dangerous.
But for most of the hourlong argument, the justices struggled to understand whether there was such a conflict in Levine’s case. Wyeth’s attorney said the FDA had rejected stronger warning labels for the anti-nausea drug. Levine’s attorney disagreed and said the agency had not focused on the special risk of injecting it.
A ruling is not expected for several months. If the court agrees with the administration, congressional Democrats have said, they will seek to revise the law and restore consumers’ right to sue.