WEST VIRGINIA RECORD

CHARLESTON -- A woman and the estate of her now-deceased father have named Pfizer Inc., Parke-Davis, and Warner-Lambert Company as being responsible for the wrongful death of her father in connection with his use of Neurontin.

In the 71-page suit, Sandra Lynn Messer and the estate of her deceased father, Michael J. Malcolm, are seeking recovery of damages for the wrongful death of Malcolm and personal injuries sustained from Pfizer and Warner-Lambert Company in connection with the designing, developing, manufacturing, distributing, labeling, advertising, marketing, 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 suit states that Pfizer intentionally encouraged off-label usage of Neurontin through direct and indirect marketing and promotional campaigns even though it knew that the drug was not effective and, in many cases, actually harmful for unapproved usage. Pfizer misleadingly endorsed other off-label uses including bipolar disorder, various pain disorders, amyotrophic lateral sclerosis (ALS), attention deficit disorder (ADD), restless leg syndrome (RLS), migraines, and drug and alcohol withdrawal seizures.

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.

In 2002, a whistleblower complaint initiated a suit against Pfizer, then known as Warner-Lambert, and this exposed the company's deceptive promotional scheme. Two years later, Pfizer agreed to pay $430,000,000 to settle any criminal charges and civil liabilities associated with the illegal marketing campaign.

Filed by Stuart Calwell of the Charleston firm of The Calwell Practice, and Andrew Finkelstein, of the New York firm of Finkelstein & Partners, the suit states that Malcolm suffered suicidal ideations and apprehension of death during the time he took Neurontin and did in fact take his life while on Neurontin, which was not helping his depression or chronic pain.

Messer is seeking general, special, punitive, and exemplary damages as well as attorneys' fees and interest in a trial by jury in the United States District Court for the Southern District of West Virginia.