The case, Wyeth v. Levine, No. 06-1249, concerns an implied form of the doctrine of pre-emption, which bars state lawsuits from people injured by products that met federal safety standards. The drug law at issue in the case says nothing about pre-emption, and the question before the court was whether the Food and Drug Administration’s approval of drug labels should knock out state lawsuits contending that the labels did not contain adequate warnings.
A broad endorsement of implied pre-emption based on regulators’ actions rather than on statements in laws enacted by Congress could shut down countless injury suits in cases involving not only drugs but also motor vehicles, household products, chemicals and agricultural products.
Several justices appeared open to the idea that pre-emption could follow from the F.D.A.’s approval of a drug label — but only if drug companies remained subject to lawsuits if they failed to disclose new information about potential risks. There was much discussion of what information should be considered new.
Other justices seemed prepared to allow pre-emption — but only if the drug agency had considered the particular risk before approving the label.
Given the justices’ interest in those refinements, the court seemed unlikely to rule broadly on the larger issues in the case: whether the agency and other federal regulators set minimum safety standards that states are free to augment or whether they make judgments about the optimal balance between risks and benefits that states must follow.
In February, however, an eight-justice majority of the court ruled, in Riegel v. Medtronic, that suits concerning injuries caused by medical devices were pre-empted by a 1976 federal law. But the underlying law in Riegel required pre-emption, in so many words; in the jargon, it involved “express pre-emption.”
The plaintiff in the case argued on Monday, Diana Levine, lost her arm after being injected with a Wyeth drug, Phenergan. The drug is safe, Ms. Levine’s lawyers said, when administered by intramuscular injection or by intravenous drip. But they said that efforts to inject the drug directly into a vein carry enormous risks.
A Vermont clinic used that third method, known as IV push, and apparently missed the vein. When the drug was exposed to Ms. Levine’s arterial blood, it caused swift and irreversible gangrene, requiring amputation of her arm below the elbow.
Ms. Levine settled with the clinic and sued Wyeth, saying the company should have added a warning telling doctors not to use the risky method.
Seth P. Waxman, a lawyer for Wyeth, said the company had provided “ample, lavish warnings” about the risks involved and left it to medical professionals to make the ultimate judgment about how to administer the drug.
Justices Samuel A. Alito Jr. and Ruth Bader Ginsburg both questioned the cost-benefit calculation that allowed the drug to be administered by IV push.
“On the benefit side of this you don’t have a life-saving drug, you have a drug that relieves nausea,” Justice Alito said. “On the risk side, you have the risk of gangrene.”
Justice Antonin Scalia said that what mattered was not whether the agency’s decision was sound but whether it had addressed the issue at all. “If you’re telling me the F.D.A. acted irresponsibly,” Justice Scalia told Ms. Levine’s lawyer, David C. Frederick, “then sue the F.D.A.”
Chief Justice John G. Roberts Jr. tried to boil down Mr. Frederick’s argument to a simple test. If the F.D.A had considered the risks involved in IV-push administration, Ms. Levine would lose; if the F.D.A. had not considered those risks, Ms. Levine would win.
Mr. Frederick said Ms. Levine would win under that analysis, saying the F.D.A. had never specifically compared the risks of methods of intravenous administration.
Mr. Waxman said he understood that “members of this court are concerned
about applying a broad, vague or freewheeling analysis.” But Ms. Levine’s
case, he added, is in the “heartland” of implied pre-emption, given that the
jury had awarded damages for Wyeth’s failure to alter the very drug label
the F.D.A. had approved.