WASHINGTON — Diana Levine went to a medical clinic with a severe migraine. She wound up with gangrene and an amputated forearm, the victim of a rare side effect from a popular antinausea drug.
"It's horrific when you think about it," said Levine, 63, a professional musician who needs a prosthetic arm to strum a few chords on her beloved guitar. "Either I'm not going to throw up, or I'm going to lose a limb."
The Vermont woman sued pharmaceutical giant Wyeth, winning a $6.7-million judgment that has triggered one of the most hotly contested cases of the Supreme Court's term. On Monday, the justices debated Wyeth's contention, which is supported by the Bush administration, that the lawsuit should be thrown out because federal law pre-empts such state court claims.
The company's argument caused divisions among the conservative bloc on the court, which has sided with corporations in several recent similar cases. Justice Samuel Alito questioned how the Food and Drug Administration could have approved the drug, Phenergan, as "safe and effective" when "you have the risk of gangrene."
Justice Anthony Kennedy disputed Wyeth's contention that it could not have followed the Vermont law under which Levine sued without violating the federal law that regulates drug labeling. "As a textual matter, as a logical matter, as a semantic matter, I don't agree with you," Kennedy, often a swing vote in important cases, told a Wyeth attorney.
But Justice Antonin Scalia intensively grilled Levine's attorney, scowling at him and saying the FDA-required warning label explicitly said that the way Levine was given the drug was dangerous in certain circumstances. "Excuse me, the risks were set forth on the labeling," Scalia said. "If you're telling me the FDA has acted irresponsibly, then sue the FDA."
The argument in Wyeth vs. Levine was the latest in an intensifying national debate over "pre-emption," a doctrine under which companies can be shielded under federal law from state lawsuits. Business groups strongly favor pre-emption, while state regulators fear it hurts consumers who are injured by harmful products.