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 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.
“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 argued Wyeth should have given stronger warnings about the dangers of administering the drug in the way she received it.
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.
“We regret that the Supreme Court disagreed,” Bert Rein, an outside lawyer for Wyeth, said in a statement.
Levine’s attorney and consumer advocates welcomed the ruling as a win for patients.
The court’s opinion “reaffirms the important role state laws play in promoting consumer safety and providing compensation for injuries,” said David Frederick, the lawyer who argued the case for Levine.
Federal pre-emption has been a major drug industry goal and was backed by the Republican Bush administration and business groups upset by large damage awards.
Stevens rejected the argument that Levine’s claims of harm were pre-empted because it would be 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 Wyeth’s argument that requiring it to comply with state-law duties to provide a stronger warning 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.
Reporting by Lisa Richwine and James Vicini, editing by Gerald E. McCormick, Dave Zimmerman and Matthew Lewis