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UPDATE 4-US top court: FDA-approved labels no legal shield
March 4, 2009 / 3:32 PM / 9 years ago

UPDATE 4-US top court: FDA-approved labels no legal shield

* U.S. Supreme Court rules against Wyeth

* Federal law does not pre-empt woman’s liability claims

* Dissenters say tragic facts make bad law

* Drug industry group says ruling could prove harmful (Adds reaction from musician and drug industry group)

By Lisa Richwine and James Vicini

WASHINGTON, March 4 (Reuters) - The U.S. Supreme Court ruled against the drugmaker Wyeth WYE.N 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 U.S. Food and Drug Administration labeling approvals do not pre-empt state laws and shield companies from damages as part of liability claims.

A Vermont jury awarded $7 million in legal 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.

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

“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.

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

“The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine” and how they should be described on the product label, said Bert Rein, an attorney for Wyeth.

Consumer advocates and Democratic lawmakers welcomed the ruling as a win for patients and a rejection of the support for federal pre-emption by the Republican administration of former President George W. Bush.

Levine said she collapsed into tears when told of the decision. “Next to getting my hand back, it’s the best they can do,” she told reporters on a conference call.

“I‘m on the ceiling. I‘m just so high about this. I‘m so glad,” she added.

In his opinion, Stevens rejected the argument that Levine’s claims were pre-empted because it was impossible for Wyeth to comply with both state law and federal labeling requirements.

He said Wyeth could have unilaterally added a stronger warning about the IV-push administration used with Levine, and there is no evidence the FDA would have rejected the change.

Under federal law and FDA regulations, the manufacturer bears responsibility for the content of its label at all times, Stevens said in the 26-page opinion.

He also rejected the argument that requiring Wyeth to comply with state law would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions.

Stevens said Levine presented evidence of at least 20 incidents before her injury in which a Phenergan injection resulted in gangrene and an amputation. As the amputations mounted, Wyeth could have analyzed the accumulating data and added a stronger warning, he said.

Stevens said the FDA traditionally has regarded state law as a complementary form of drug regulation.

“The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the post-marketing phase as new risks emerge,” he said.

Chief Justice John Roberts and justices Antonin Scalia and Samuel Alito dissented. “This case illustrates that tragic facts made bad law,” Alito wrote.

Neither federal law nor FDA regulations “suggest that juries may second guess the FDA’s labeling decisions,” he wrote.

The drug industry’s main lobbying group warned the ruling could prove harmful. “Patients could ultimately suffer if the Supreme Court’s decision forces healthcare providers and patients to second-guess FDA-approved labeling,” said Ken Johnson, spokesman for the Pharmaceutical Research and Manufacturers of America. (Reporting by Lisa Richwine and James Vicini, editing by Dave Zimmerman, Matthew Lewis, Tim Dobbyn)

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