Court Rules Against Drug Companies in Amputation Case
Thursday, March 5, 2009
The Supreme Court ruled yesterday in favor of a woman who had her arm amputated after an improper injection of an anti-nausea medication and said drugmakers could not rely on federal regulation to shield them from lawsuits brought under state consumer protection laws.
The 6 to 3 vote in the court's most anticipated business decision of the term was a rejection of Bush administration policy and a major setback to pharmaceutical companies, which face thousands of lawsuits in state courts from patients who allege that drugs have harmed them.
In 2006, the Food and Drug Administration changed its policy and adopted rules that said the agency's approval of a drug insulated drugmakers from state lawsuits.
But Justice John Paul Stevens, writing for the majority, said there was "powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness."
He added that the FDA has "limited resources" for overseeing the more than 11,000 drugs on the market, and that "state tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly."
The court ruled in favor of Diana Levine, a guitar-playing children's musician from Vermont whose right arm had to be amputated after an improper injection of Wyeth Pharmaceutical's drug Phenergan, a common nausea treatment. She had gone to a clinic for treatment of a migraine.
Phenergan can be injected into muscle, through a drip, or directly into a vein, in what is called an IV-push. The latter method is riskier, because if the drug reaches an artery, gangrene is immediate and irreversible, and that is what happened to Levine.
After settling her suit against the clinic, Levine convinced a jury that Wyeth could have strengthened its warnings about the dangers of the drug without the involvement of the FDA and won an award of almost $7 million.
Levine said in a conference call with reporters that the Supreme Court decision in Wyeth v. Levine has brought her "unrestrained joy" and added, "Next to getting my hand back, it's the best they could do, and it's the least they could have done."
David Frederick, Levine's attorney, said the "landmark case" will have a "transformative effect on [Levine's] life and the life of consumers" harmed by the side effects of drugs.
The issue is vital for the business community, which argues that meeting a federal standard should protect companies from huge awards imposed by juries that might be swayed by the emotional aspects of the cases before them.
Thousands of product-liability suits have flooded state courts in recent years, with more than a third filed against drug companies.