The first of over 1,200 lawsuits against Pfizer alleging that Neurontin side effects increase the risk of suicide will begin trial this week. The case is one both the judge and the plaintiff’s attorney say will be hard to win, so a plaintiff’s verdict would indicate serious trouble for Pfizer’s ability to defend itself against the other Neurontin lawsuits.
Neurontin (gabapentin) is an epilepsy medication approved by the FDA in 1983, which generated $387 million in sales for Pfizer in 2008.
The FDA ordered that Neurontin and other epilepsy drugs add information to their warning labels late last year about the risk of suicide, years after the first lawsuits were filed against Pfizer indicating that they failed to provide adequate warnings based on information available to them while developing the drug and from post-marketing reports.
According to Bloomberg news, plaintiff’s attorneys plan to expose the history of marketing for Neurontin during the trial, alleging that the manufacturers hid health risks and pushed the medication for unapproved uses, which drug makers are not allowed to do.
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.
The first Neurontin lawsuit, which is scheduled to begin trial today, involves a claim filed by the family of Susan Bulger, who took the drug shortly before hanging herself in 2004. Bulger was taking Neurontin off-label for mood swings, and her husband claims she took the medication an hour before he and their 4-year-old daughter found Bulger had hung herself in their basement.
U.S. District Judge Patti B. Saris, who is overseeing the consolidated Neurontin litigation in federal court, has indicated the plaintiff’s attorneys have an uphill battle in this first case, as Bolger had a history of mental disorders, previous suicide attempts and was a known cocaine user.
Pfizer selected the Bulger case for the first trial. However, according to a report in The American Lawyer, plaintiff’s lawyer Mark Lanier indicates that Pfizer’s decision to select what they considered a weak case to try first may backfire, as it places tremendous pressure on Pfizer attorneys to not lose the case.