California consumer groups Tuesday filed a suit accusing Pfizer Inc. and its Parke-Davis unit of circumventing federal government rules to promote scientifically unproven “off-label” uses of their Neurontin drug.
In a lawsuit filed in a Los Angeles Superior Court, the coalition of groups, Community Catalyst’s Prescription Access Litigation, alleged that Parke-Davis launched an illegal promotional campaign in 1995 to attract new patients to Neurontin, which had been approved by the U.S. Food and Drug Administration only for the treatment of epilepsy.
Neurontin’s marketing is the subject of a grand-jury investigation begun by the U.S. attorney’s office in Boston. In addition, 47 states and the District of Columbia have launched criminal or civil probes.
The latest lawsuit, filed on behalf of the California Public Interest Research Group, the Congress of California Seniors and USAction, alleges that the campaign included illegal cash kickbacks to physicians and other methods to increase sales of the drug for non-approved uses.
Parke-Davis sought to promote Neurontin for treatment of at least 13 separate conditions, the suit claims, including migraines, bipolar disorders and restless leg syndrome.
The suit is asking the court to prohibit Pfizer from promoting Neurontin for off-label uses and to disgorge profits the company received through the allegedly illegal practices.
A Pfizer spokeswoman declined to comment on the lawsuit, citing company policy.
Pfizer acquired the rights to Neurontin when it bought Warner-Lambert Co. and its Parke-Davis unit in 2000. The drug has become one of Pfizer’s most successful drugs, with expected 2002 sales of $2 billion.