Yet another class action has been filed against pharmaceutical manufacturer Pfizer, Inc., and Warner-Lambert Company over its questionable, but highly lucrative marketing of the epilepsy drug Neurontin (gabapentin), for off-label uses. This latest action is brought by the International Union of Operating Engineers Local No. 68 Welfare Plan on behalf of all U.S. consumers who paid some or all of the cost of an off-label-use Neurontin prescription since 1994.The Union claims that its prescription drug coverage plan incurred substantial costs for Neurontin prescriptions, the vast majority of which were for conditions other than epilepsy, the official FDA use for the drug. Plaintiffs allege that Pfizer has 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 Neurontin, in violation of the federal Racketeer Influenced and Corrupt Organizations Act. The action seeks unspecified compensatory and triple punitive damages.

The FDA gave approval for the marketing Neurontin as an epilepsy drug in 1993. Thereafter, defendants allegedly decided not 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 companies 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.

Defendants 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 companies 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 themselves. FDA regulations require that such studies be independently authored.

Defendants also allegedly recruited physicians--including those who wrote high volumes of Neurontin prescriptions--to act as consultants, 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 of Neurontin are not medically accepted by the American Hospital Formulary Service Drug Information, or any relevant peer-reviewed literature. However, the off-label strategy was wildly successful from a financial standpoint—the Complaint in this action states that nearly 90% of Neurontin prescriptions were for off-label uses by 2003, and that sales of Neurontin jumped from 97.5 million in 1995, when the off-label promotions began, to a whopping 2.7 billion in 2003.

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 the whistle-blower, David Franklin, who assisted in the case. However, this settlement does not provide any financial recourse for the millions of private consumers who paid for questionable Neurontin prescriptions. As a result, a number of private class actions by consumers and prescription drug coverage providers have been filed.