Pfizer, unit sued over marketing of epilepsy drug

NEWARK, N.J.--A union health plan is seeking to recover billions of dollars of damages in a racketeering lawsuit charging Pfizer Inc. and one of its subsidiaries with fraudulently marketing the epilepsy drug Neurontin.

The suit, filed by the Alaska State Employees Assn. health benefit trust, alleges that New York-based Pfizer and its Warner-Lambert Co. unit reaped billions of dollars of fraudulent revenues by selling Neurontin to treat a variety of ailments for which it was never approved by the U.S. Food and Drug Administration.

Warner-Lambert agreed last month to pay $430 million to settle criminal and civil charges brought by federal and state prosecutors over its marketing of Neurontin. The company pleaded guilty to two felony counts of violating the Food, Drug and Cosmetic Act and paid a $240 million fine. It also paid $190 million for losses to Medicaid programs and other damages.

Pfizer, which acquired Warner-Lambert in 2000, after the alleged fraud occurred, took a $427 million pretax charge in the fourth quarter of 2003 to cover the settlement.

The ASEA suit, filed last week in U.S. District Court in Newark, N.J., mirrors the federal and state charges and seeks damages on behalf of health plans and others that have paid for Neurontin for unapproved uses since Jan. 1, 1994.

Approved by the FDA as a partial treatment for epilepsy in 1993, Neurontin was aggressively marketed by Warner-Lambert for numerous "off-label" uses, including treatment of bipolar mental disorders, attention deficit disorder, migraine, Lou Gehrig's disease and various pain disorders, according to the suit, which seeks class action status.

From 1995 to 2003, Warner-Lambert's revenues from Neurontin jumped from $97.5 million to $2.7 billion. By 2003, 90% of Neurontin prescriptions were for off-label uses, compared with 50% in 1996, according to the ASEA complaint.

In selling the drug, Warner-Lambert falsely claimed that clinical trials and other studies backed its efficacy for off-label uses, misrepresented certain employees as medical or scientific specialists, and concealed the company's sponsorship of articles used to sell Neurontin for off-label purposes, the lawsuit charges.

The drug company also illegally paid physicians to prescribe Neurontin and coached doctors and pharmacists on how to conceal the off-label use of the drug on claim forms submitted to third-party payers, the complaint alleges.

A Pfizer spokesperson could not be reached for comment on the suit.