Lilly not pleased with Supreme Court decision-WEB ONLY

The decision in Wyeth v. Levine is likely to have ramifications for big
drug companies, including Indianapolis-based Eli Lilly and Co.

In a 6-3 decision, the court rejected Wyeth Pharmaceuticals’ claim that
federal approval of its Phenergan anti-nausea drug should have shielded
the company from lawsuits like the one filed by Diana Levine of Vermont.

Levine’s lawsuit said she wasn’t sufficiently warned of the risks of
using Phenergan. But Bert Rein, a Washington lawyer who represents
Wyeth, said the company’s label complied with federal law.

“The medical and scientific experts at FDA are in the best position to
weigh the risks and benefits of a medicine and to assess how those
risks and benefits should be described in the product’s label,” Rein
said in a statement.

Ed Sagebiel, manager of corporate communications for Lilly, said the
company “is still reviewing the various details in the Wyeth v. Levine
case to fully understand the implications of [yesterday’s] Supreme
Court decision.”

But, he said in prepared statement: “Lilly believes that the expert
scientists and medical professionals at the [FDA] are in the best
position to evaluate voluminous information about a medicine’s benefits
and risks, and to determine which safety information to include in the
drug label. We believe that health care providers and patients rely on
FDA-approved drug labeling every day in making critical decisions about
whether a medicine is the best treatment for an individual.
  
“Unfortunately, patient care could ultimately suffer if the Supreme
Court’s decision forces health care providers and patients to
second-guess FDA-approved labeling.”
 
Levine, 63, struggled with her emotions when told of the ruling in a
phone call from an Associated Press reporter yesterday: “Oh, my God.
I’m so, so happy. I can’t believe this phone call,” she said.

“I’ve been waiting for so long, and I had no idea of what the chances
were. I’m just ecstatic. I’m going to have to sit down,” said Levine, a
professional guitar and piano player. She now plays with one hand, and
sings.
 
Wyeth is in the process of being bought by rival Pfizer Inc. in a $68 billion deal that is expected to close later this year.

The decision is the second this term to reject business groups’
arguments that federal regulation effectively pre-empts consumer
complaints under state law.

A Vermont jury agreed with Levine’s claim that Wyeth failed to provide
a strong and clear warning about the risks of quickly injecting the
drug into a vein, a method called IV push. Gangrene is likely if the
injection accidentally hits an artery – precisely what happened to
Levine.

The company appealed and, backed by the Bush administration, argued
that once a drug’s warning label gets approval from the Food and Drug
Administration, the label can’t be changed without further FDA approval
and consumers cannot pursue state law claims that they were harmed.

Justice John Paul Stevens, writing the majority opinion, said Wyeth could “unilaterally strengthen its warning.”

Stevens said he was persuaded that until a recent change by the FDA,
the agency “traditionally regarded state law as a complementary form of
drug regulation” because it monitors 11,000 drugs.

Justice Clarence Thomas agreed with the outcome of the case, but did
not join Stevens’ opinion. Justice Samuel Alito wrote a dissent that
was joined by Chief Justice John Roberts and Justice Antonin Scalia.

“This case illustrates that tragic facts make bad law,” Alito said.
“The court holds that a state tort jury, rather than the Food and Drug
Administration, is ultimately responsible for regulating warning labels
for prescription drugs.”

The FDA has approved the use of Phenergan by injection, including the
method at issue in Levine’s case. The drug has been available for
decades to treat nausea and when used properly, both sides agree it is
safe and effective.

The Bush administration and business groups aggressively pushed limits
on lawsuits through the doctrine of pre-emption – asserting the primacy
of federal regulation over rules that might differ from state to state.

The Supreme Court had largely agreed, ruling last term that FDA
approval shields medical devices from most lawsuits. That case turned
on a provision of federal law prohibiting states from imposing their
own requirements on the devices.

The Levine case drew a lot of attention because the administration and
Wyeth contended that, although the federal Food, Drug and Cosmetic Act
lacks a similar provision, drug manufacturers also are protected from
most suits over federally approved drugs.

Stevens said there could be circumstances where consumer lawsuits would
not be allowed, including if the FDA had considered and rejected a
stronger warning label.

But that was not the case with Phenergan, he said