* 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 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
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)