* Epilepsy drug was marketed for migraines, bipolar disorder
* Appeals panel also revives two similar lawsuits
* Off-label marketing of Neurontin has earned Pfizer a
By Nick Brown
April 3 A federal appeals court said Pfizer Inc
should pay about $142 million to cover costs for the
marketing and prescribing of epilepsy drug Neurontin for
unapproved uses, a practice that has also earned it a hefty
A panel of appellate judges in Boston on Wednesday refused
to overturn a ruling in favor of Kaiser Foundation Health Plan,
which claimed it had been damaged after prescribing Neurontin
for conditions it did not effectively treat, based on fraudulent
marketing by Pfizer, the largest U.S. drugmaker.
In related appeals, the panel also revived similar claims
from insurer Aetna and class action allegations from
Harden Manufacturing Corp, restoring lawsuits that had been
thrown out by a lower court.
The ruling in the Kaiser case, which deals the biggest
immediate blow to Pfizer, upholds a lower court's decision not
to grant Pfizer a new trial after a jury had awarded it $142
The jury found that Pfizer had marketed Neurontin for
bipolar disorder, migraines and neuropathic pain, none of which
had been approved by the U.S. Food & Drug Administration.
The verdict followed a $240 million criminal fine in 2004
paid by Pfizer's Warner-Lambert unit, as well as a $190 million
civil fine paid by Pfizer in connection with the off-label
Neurontin, developed by a Warner-Lambert unit, was approved
in 1993 to treat seizures at a maximum dose of 1800 milligrams
per day. Warner-Lambert was later acquired by Pfizer.
The drugmaker initially forecast about $500 million in
revenue generated by Neurontin, but in 1995 began marketing it
for off-label uses in an attempt to increase its earning
potential -- a move that apparently worked, reaping $2 billion
from Neurontin sales in 2003 alone, the appellate court said.
Pfizer marketed Neurontin for off-label uses directly to
doctors, sponsored misleading informational supplements and
suppressed negative information about the drug, the opinion
The company's internal marketing plan for certain drugs,
including Neurontin, called for the development of relationships
with Kaiser officials "who are not considered whistle blowers,"
according to the opinion.
In a statement, Kaiser said it was "very pleased" and that
"justice has been achieved for our members and the physicians,
pharmacists and staff who care for them." David Frederick, an
attorney for Kaiser, said he was "gratified by the court's
carefully crafted decision."
Pfizer was less satisfied, saying in a statement it believes
"there was no basis in fact or law" for the awards in the Kaiser
In the Aetna and Harden cases, Pfizer said it believed the
lower court's dismissals were the right move and that it
"disagrees with the conclusions" of the appeals court.
"We are exploring our appellate options in all three of
these cases," the company said.
Pfizer's attorneys in the case, from law firms Skadden Arps
Slate Meagher & Flom and Quinn Emanuel Urquhart & Sullivan,
could not be reached.
The Kaiser cases are Kaiser Foundation Health Plan et al v.
Pfizer Inc et al, U.S. Court of Appeals for the First Circuit,
Nos. 11-1904 and 11-2096.