A federal jury in Boston has found that Pfizer violated U.S. racketeering laws by illegally promoting off-label uses of its epilepsy drug Neurontin, and the drug maker may be forced to pay more than $142 million in damages in the case.
The Neurontin lawsuit, brought by Kaiser Foundation Health Plan, Inc. and Kaiser Foundation Hospitals, charged Pfizer with illegal promotion of Neurontin for migraines, bipolar disorder and other conditions. The plaintiffs alleged that they were forced to overpay $90 million for the medication, which did not perform as advertised.
The U.S. District Court jury in Boston deliberated for two days after a month-long trial, and awarded the plaintiffs $47.36 million in damages. However, since the charges include claims that Pfizer violated the federal Racketeer Influenced and Corrupt Organizations Act (RICO), the jury award is automatically tripled, meaning that if the ruling stands Pfizer would have to pay $142.1 million in total.
The case is just one of about 1,200 lawsuits over Neurontin that Pfizer is facing. Most of the lawsuits have been brought by individual plaintiffs who say that Neurontin side effects increase the risk of suicide. In 2008, the FDA required Neurontin and similar epilepsy drugs to begin carrying label warnings alerting users to the risk of suicidal thoughts.
While doctors are free to prescribe drugs for uses not approved by the FDA, manufacturers are prohibited from marketing the drugs for such uses that they have not established are safe and effective. In 2004, Parke-Davis, a division of Warner-Lambert that was acquired by Pfizer, paid $430 million to the U.S. Justice Department over claims that they were illegally promoting Neurontin for off-label uses, including control of mood swings. Last fall, Pfizer paid the Justice Department $2.3 billion to settle a number of off-label marketing claims which included its marketing of Neurontin.
Neurontin (gabapentin) is an epilepsy medication approved by the FDA in 1983, which generated $387 million in sales for Pfizer in 2008.
The first Neurontin lawsuit to go to trial, which involved a claim brought by the family of Susan Bolger, who committed suicide in 2004 after taking the drug, was dropped last summer before a verdict was ever returned.
All federal lawsuits involving Neurontin have been consolidated before U.S. District Judge Patti B. Saris, and the next Neurontin lawsuit trial is scheduled to begin next week in the same court.