A class action has been filed against pharmaceutical manufacturer Pfizer, Inc., Parke-Davis, and Warner-Lambert Company on behalf of persons who paid out-of-pocket expenses for the drug Neurontin (gabapentin), who allege that the companies harmed consumers by conspiring to circumvent drug approval regulations set up by the U.S. Food and Drug Administration (FDA), and promoting scientifically unproven "off-label" use of the drug, in violation of the federal Racketeer Influenced and Corrupt Organizations Act. The action seeks unspecified compensatory and triple punitive damages.

The FDA gave Parke-Davis approval to market Neurontin as an epilepsy drug in 1993. In 1995, Parke-Davis allegedly decided that it did not want to undertake the clinical trials that FDA requires in order to approve new uses for a prescription drug because it would be too expensive and time consuming. The company decided to launch a broad campaign to promote the drug for treating at least 13 separate conditions, including migraines, bipolar disorder and restless leg syndrome by hiring outside firms to help exploit a loophole in government regulations that prohibit the promotion of drugs for unapproved uses, except in published research and medical education. Disguised as "medical education" for the doctors or "consulting" for the company, that campaign allegedly included illegal cash kickbacks to physicians and other sales ploys to pump up sales of the drug for non-FDA approved uses.

Parke-Davis allegedly recruited and paid numerous physicians to participate in sham studies that the company then publicized to persuade other physicians to prescribe Neurontin in doses far higher than FDA authorizes. In addition, the action charges, the company paid physicians to attach their names to scientific articles promoting the off-label use of Neurontin, even though the articles were ghost-written by third-party authors instead of by the doctors paid by Parke-Davis. FDA regulations require that such studies be independently authored.

Parke-Davis also allegedly recruited physicians--including those who wrote high volumes of Neurontin prescriptions--to act as consultants to the company, paying them to attend meetings at hotels and resorts. In this scheme, physicians were not required to provide consulting services, but instead sat through presentations by the company which were designed to influence their prescription-writing behavior.

It has been widely noted that the off-label uses Parke-Davis promoted are not medically accepted by the American Hospital Formulary Service Drug Information, or any relevant peer-reviewed literature. Parke-Davis was acquired by Pfizer when it bought Warner-Lambert in 2000. Parke-Davis was successful in its off-label strategy-- published reports state that 78% of Neurontin prescriptions had been written for treatments other than epilepsy, earning sales revenues of $1.3 billion.

Pfizer recently agreed in a Department of Justice settlement to plead guilty to violating the Food, Drug and Cosmetic Act. Along with a criminal fine, the agreement includes $152 million in civil fines to be shared among state and federal Medicaid agencies and whistle-blower David Franklin.