Supreme Court rules against Wyeth in liability case

By Lisa Richwine and James Vicini

WASHINGTON (Reuters) - The U.S. Supreme Court ruled against the drugmaker Wyeth on Wednesday, holding that pharmaceutical companies can be held liable for harm from medicines that carry warnings approved by federal regulators.

By a 6-to-3 vote in a major defeat for the pharmaceutical industry, the high court ruled that labeling approvals by the U.S. Food and Drug Administration do not pre-empt state laws and shield companies from legal damages as part of liability claims.

A Vermont jury awarded $7 million in damages to a guitarist, Diana Levine. Part of her arm had to be amputated after she was improperly injected with the anti-nausea drug Phenergan made by Wyeth as part of treatment for a migraine.

The justices affirmed a Vermont Supreme Court ruling that upheld the award and rejected Wyeth's argument that labeling approval by the FDA pre-empts state law liability claims.

"The question we must decide is whether the FDA's approvals provide Wyeth with a complete defense to Levine's tort claims. We conclude that they do not," Justice John Paul Stevens concluded in the court's majority opinion.

Levine's attorneys said Wyeth should have given stronger warnings about the dangers of administering the drug in the way she received it.

Wyeth said its labeling provided clear instructions and warnings on Phenergan. The company also said it believed federal law prohibited it from revising the information.

"We regret that the Supreme Court disagreed," Bert Rein, an outside lawyer for Wyeth, said in a statement.