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By a six-to-three vote, the U.S. Supreme Court rejected a major effort by the pharmaceutical industry to win immunity from consumer lawsuits. The court said that federal approval for a drug label does not let the manufacturer off the hook from consumer lawsuits for failure to adequately warn patients about potential dangers. NPR legal affairs correspondent Nina Totenberg reports.
NINA TOTENBERG: In one sense, the Court's ruling was a personal victory for Vermont musician Diana Levine, who went to a clinic for treatment of a migraine headache and ended up losing her arm.
She was injected with a drug Phenergan, using a method which carries a small risk of causing irreversible gangrene. Within hours, Levine's hand and arm were turning black, and the arm was soon amputated.
She sued the drug manufacturer Wyeth, contending that it failed to adequately warn doctors and patients about using this risky method of administering the drug when other methods are available. Diana Levine.
Ms. DIANA LEVINE (Musician): This whole thing was avoidable. The only reason it happened is because Wyeth had not changed their label to disallow this method of administration.
TOTENBERG: A jury agreed and awarded her some $6 million in damages. Wyeth appealed all the way to the U.S. Supreme Court, contending that once the FDA approves a label, the drug manufacturer cannot be sued in state court for failure to warn.
But yesterday, the Court rejected the industry's arguments, noting that serious hazards have been uncovered by such suits. In Vermont, Levine was ecstatic, saying the first thing she would do is adapt her car for one-handed driving. But she saw a bigger message.
Ms. LEVINE: It's almost like another sign of hope. The justice system worked, and the fact that big business - just because they're big business and have connections and lobbyists and a lot of money so they can drag it on and on and on - doesn't mean they're going to win.
TOTENBERG: Indeed, yesterday's court ruling was a major loss not only for industry, but for the Bush administration, which in a break with precedent, sided with industry on the issue. Previously, administrations Republican and Democratic had always taken the position that FDA regulations work in tandem with state lawsuits.
Yesterday, the Supreme Court said the Bush administration's views were entitled to, quote, "no weight," because it had so disregarded the history of the Food and Drug Act and the congressional purpose in enacting the law. Indeed, the Court observed, Congress has repeatedly declined to enact provisions that would bar state lawsuits and serious safety problems unknown to the FDA uncovered by such suits.
If yesterday's Court decision was a personal victory for Diana Levine, it was a larger loss for the business community, which worked in the Bush years to enact many other product regulations as a way to block state lawsuits. Now those regulations for other products are in doubt, too. Industry advocate Victor Schwartz.
Mr. VICTOR SCHWARTZ (Pharmaceutical Industry Advocate): I don't want to make the jump that this is dominos and that they all fall.
TOTENBERG: But Georgetown law professor David Vladeck, a consumer advocate, says everyone on both sides of the issue saw the Levine case as setting the ground rules well beyond pharmaceuticals.
Professor DAVID VLADECK (Consumer Advocate; Law Professor, Georgetown University): This case deals a body blow, I think, to the Bush administration's effort to use regulatory preemption to wipe away state tort law.
TOTENBERG: Nina Totenberg, NPR News, Washington. Transcript provided by NPR, Copyright NPR.
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