The U.S. Supreme Court ruled that patients can sue drugmakers for failing to provide adequate safety warnings, upholding a $7 million award to a musician who lost her arm after being injected with Wyeth’s Phenergan nausea treatment.
The justices, voting 6-3, said that pharmaceutical companies aren’t shielded from suit by the Food and Drug Administration’s approval of a treatment and its packaging information.
“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” Justice John Paul Stevens wrote for the court.
Injured patients and their families are pressing thousands of suits around the country, seeking billions of dollars in damages from drug companies. Wednesday’s decision might help former users of Wyeth’s Prempro and Premarin menopause drugs and consumers of AstraZeneca’s antipsychotic drug Seroquel.
The impact isn’t clear for allegations that Pfizer and GlaxoSmithKline should have done more to warn that their antidepressants might cause suicidal tendencies. The FDA for many years said warnings weren’t necessary for adult patients. The justices have deferred action on a pending patient appeal in an anti-depressant case while they considered the Wyeth case.
In his opinion for the court, Stevens left open the possibility that suits might be barred in cases where the FDA explicitly considered and rejected a requirement for stronger warnings.
“It’s still leaves open some turf for industry, but it narrows the playing field,” said Mark Herrmann, a Chicago product-liability lawyer who represents companies and co-writes a blog on drug and medical-device law.
The ruling is a victory for Diana Levine, 63, a children’s musician who says Wyeth should have warned against the injection method that caused gangrene in her right arm.
Levine’s lawyer, David Frederick, called the ruling a “broad victory for consumers.”
Justices Anthony Kennedy, David Souter, Stephen Breyer, Ruth Bader Ginsburg and Clarence Thomas joined Stevens in the majority. Thomas wrote separately to say the court should have been even more deferential to state laws.
Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alito dissented. Alito, writing for the three, said state-law product-liability suits would interfere with the federal drug-approval system.
“The FDA told Wyeth that Phenergan’s label renders its use â€˜safe,’ ” Alito wrote. “But the state of Vermont, through its tort law, said, â€˜Not so.’ ”
Levine received two injections of Phenergan in 2002 to treat nausea associated with a migraine headache. The second injection was administered using an intravenous or “IV push” method, which uses a syringe to push the medication directly into the patient’s vein.
The drug penetrated Levine’s artery, destroying it and eventually killing much of the tissue in her arm and hand. She underwent two amputations, first losing her right hand and then her arm up to her elbow.
Although Phenergan’s two-page label at the time included a warning about injection into an artery, it didn’t advise not to use the IV push technique.
The Vermont Supreme Court upheld the award, saying federal drug law didn’t preclude the suit. The state court said the FDA never considered whether the drugmaker should include a warning against the IV push method.
Wyeth, which is based in Madison, N.J., also makes Advil pain medicine.
U.S. drug-approval law bars state rules that create a “direct and positive conflict” with federal requirements.
The administration of former President George W. Bush backed the industry, arguing that jury awards can interfere with the FDA’s work by forcing drugmakers to exaggerate some dangers.