Warner-Lambert, Pfizer Inc., and Parke-Davis are listed as defendants in the wrongful death lawsuit filed by a woman and the estate of her now-deceased father, in conjunction with his use of Neurontin.
The suit, seeks recovery of damages for the wrongful death of her father and for personal injuries sustained from Pfizer and Warner-Lambert Co. in connection with the developing, manufacturing, distributing, advertising, marketing, promotion, designing, labeling, promoting and sale of the prescription drug Neurontin.
Neurontin is used in the treatment of post-herpetic neuralgia (PHN), epilepsy, and partial seizures in adults. The drug, manufactured by Pfizer, first received FDA approval in 1993 as an “adjunctive therapy” for patients suffering from epilepsy. Since that time, the FDA has also approved Neurontin for use in patients who are afflicted with PHN. However, because of the direct and indirect marketing of Neurontin, many doctors and patients were duped into believing it was approved for “off-label” uses such as, in the case of Malcolm, depression and chronic pain.
The lawsuit alleges Pfizer deliberately encouraged off-label prescribing of Neurontin through direct and indirect marketing although the company knew the drug was not effective and in many cases, harmful for unapproved usage. Pfizer misleadingly endorsed other off-label uses including bipolar disorder, migraines, attention deficit disorder (ADD) and other health issues.
In the suit filed on April 14, Messer claims the FDA never approved Neurontin for use in any of these conditions. Studies have not established the efficacy or safety of Neurontin for any of these off-label uses. In fact, a 1998 study sponsored by Parke-Davis, who is owned by Pfizer, found that patients with bipolar disorder taking Neurontin did worse than those patients taking a placebo. However, because it was owned by Pfizer, it chose to withhold the findings for two years and, in the meantime, continued to promote Neurontin for off-label usage.