Massachusetts District Court Denies Class Certification Motion in NEURONTIN Litigation

September 5, 2007

On August 29, 2007, the U.S. District Court for the District of Massachusetts denied a motion for class certification in ongoing litigation concerning Parke-Davis’s (a then-Warner-Lambert and now-Pfizer subsidiary) anticonvulsant drug product NEURONTIN (gabapentin).  The suit, filed in May 2004, alleges that Parke-Davis was involved in a fraudulent scheme to market and sell NEURONTIN for “off-label” uses (i.e., uses not approved by FDA) in violation of the Racketeer Influenced and Corrupt Organizations Act (“RICO”), the New Jersey Consumer Fraud Act, and common law fraud and unjust enrichment.  FDA approved NEURONTIN in 1993 for use as an adjunctive therapy in the treatment of partial seizures in adults with epilepsy, and in 2002 for the management of post-herpetic neuralgia. 

In earlier litigation (Franklin v. Parke-Davis), Parke-Davis was accused of illegal marketing practices, including the “off-label” promotion of NEURONTIN. (In 2001, over 80% of NEURONTIN’s $1.8 billion in sales were from “off-label” uses.)  In May 2004, Warner-Lambert admitted that Parke-Davis aggressively marketed NEURONTIN by “illicit means” for “off-label” uses including bipolar disorder, pain, migraine headaches, and drug and alcohol withdrawal.  The company agreed to plead guilty and consented to $430 million dollars in penalties. (See article here).

In this latest case involving NEURONTIN, the Plaintiffs proposed to certify a class (for class action purposes) comprising:

All individuals and entities in the United States and its territories who, for purposes other than resale, purchased, reimbursed, and/or paid for Neurontin for indications not approved by the FDA during the period from January 1, 1994, through the present. For purposes of the Class definition, individuals and entities “purchased” Neurontin if they paid some or all of the purchase price.

In denying the Plaintiffs’ motion to certify a nationwide class the court stated:

The plaintiffs have not identified any case in which a court has certified a class of consumers that necessarily includes a substantial number of unidentifiable non-injured persons. . . .  Here, there is no way to identify injured class members, and plaintiffs have not proposed a feasible [] distribution process.

The court, however, also left open the possibility that the Plaintiffs might yet be able to establish a class:

This case is troublesome because defendants allegedly used a national marketing scheme to promote a fraud. If true, they should not get off scot-free if there is a practical statistical way to address the difficult causation issues. . . .  If only a de minimis number of doctors prescribed Neurontin for an off-label condition, and then off-label prescriptions skyrocketed after a fraudulent campaign for that indication (i.e., migraines or bipolar), the Court will consider statistical proof as sufficient to demonstrate that most purchasers in that period were injured. At present, however, the record does not contain such a proffer.

In addition to providing a good description of the tactics used to promote NEURONTIN for “off-label” uses, the August 29th ruling also provides a good overview of one judge’s description of the law concerning “off-label” drug use. 

Categories: Enforcement