WASHINGTON (Reuters) - Pharmaceutical companies should not be liable for harm from medicines that carry warnings approved by federal regulators, lawyers for drugmaker Wyeth and the Bush administration told the U.S. Supreme Court on Monday.
The court is considering a case that could sharply limit lawsuits against drugmakers if the justices decided Food and Drug Administration approval shielded companies from liability claims under state law.
Wyeth is battling a guitarist, Diana Levine, who lost part of an arm after she was improperly injected with an anti-nausea drug made by the company as part of treatment for a migraine.
The prescribing instructions for the drug, Phenergan, “plainly comprehended and warned about the specific risks” of giving the drug in the way Levine received it, attorney Seth Waxman, arguing for Wyeth, told the court.
The company was required to use the FDA-approved warnings and could not have changed them without the agency’s permission, Waxman said.
But Levine’s lawyer said Wyeth knew the injection method used for Levine was dangerous and the company should have put a stronger warning on the drug.
“These kinds of risks come to light frequently with drugs that are on the market, and the need to revise these labels is the duty of the manufacturer,” attorney David Frederick said.
Justice Antonin Scalia appeared to back Wyeth’s position.
“If you’re telling me the FDA acted irresponsibly, then sue the FDA,” Scalia said. But holding the company liable could lead to manufacturers overwarning about beneficial drugs just to avoid lawsuits, he said.
“It would not promote public safety if you believe that the name of this game is balancing benefits and costs,” Scalia said.
The justices are weighing whether FDA approval preempts state laws and protects companies from legal damages. In Levine’s case, a Vermont jury awarded her $7 million.
Federal preemption has been a goal of the pharmaceutical industry for years and has been supported by the Republican George W. Bush administration. The court’s ruling in the Wyeth case also could affect millions of other businesses, the U.S. Chamber of Commerce has said.
Justice Ruth Bader Ginsburg seemed concerned that the FDA does not always make the right decision about whether a medicine is too dangerous or has proper warnings, a position argued by Levine’s lawyers.
“Considering the huge number of drugs, is the FDA really monitoring every one of these?” Ginsburg asked.
With Phenergan, “the risk of gangrene and amputation is there. No matter what benefit there was, how could the benefit outweigh that substantial risk?” she added.
A decision is expected by the end of June.
The Supreme Court ruled in favor of federal preemption earlier this year. In February, the justices sided 8-1 with medical device maker Medtronic Inc after it was sued by a man harmed by a catheter during an artery-clearing procedure.
If the court ruled strongly in favor of preemption again, Democrats in Congress have pledged they would push legislation to preserve a patient’s right to sue under state law.
The pending case is Wyeth v. Levine.