Neurontin Settlement Proposed for $325M to Resolve Marketing Lawsuits

Pfizer has reportedly agreed to pay $345 million to settle accusations of health care fraud regarding the marketing of the epilepsy drug Neurontin.  

The agreement was announced in the U.S. District Court in Boston on Friday, resolving allegations that the drug maker illegally marketed Neurontin for uses not approved by the FDA.

Although doctors can prescribe any FDA approved drugs for any purpose they see fit, it is illegal for drug companies to promote such “off-label” uses since they have not established that it is safe and effective.

Pfizer has been facing Neurontin off-label marketing allegations for 10 years, and this is the second major lawsuit settlement over the matter in the last two months. In April, the company announced it had also reached a $190 million Neurontin marketing settlement with members of a class action lawsuit consisting of users of the drug who say the company not only illegally marketed it, but also artificially inflated prices.

This latest Neurontin settlement affects third-party payers, such as insurance companies and health care benefit providers, who say they were defrauded by Pfizer’s activities when they had to pay for Neurontin prescriptions that should not have happened. However, Pfizer continues to refuse to admit wrongdoing as part of the settlement.

Pfizer agreed to the settlements two years after being hit with a $47.36 million verdict in a trial involving similar accusations brought by the Kaiser Foundation. A federal judge then tripled the award to $142 million under U.S. racketeering laws designed to combat organized crime. Pfizer’s attempts to appeal the verdict failed.

Neurontin (gabapentin) is an epilepsy medication approved by the FDA in 1983, which generated $387 million in sales for Pfizer in 2008.

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.

In 2009, Pfizer paid the Justice Department $2.3 billion to settle a number of off-label marketing claims which included its marketing of Neurontin.

The company has also been hit by hundreds of Neurontin lawsuits brought by individual plaintiffs, who allege 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.