McGraw

CHARLESTON - The state Attorney General's office is alleging that a pharmaceutical company is improperly marketing one of its drugs for uses other than it's intended purpose.

The New York, N.Y-based Pfizer is named in an deceptive trade practices suit in Kanawha Circuit Court. The suit, which was filed on Sept. 10, and on behalf of the state of West Virginia by Attorney General Darrell V. McGraw, alleges Pfizer for the better part of this decade has promoted the use of an anti-psychotic drug for off-label use.

According to court records, Pfizer began marketing Geodon to the public in February 2001 following its approval by the U.S. Food and Drug Administration. Its intended purpose is to treat schizophrenia.

Geodon, the suit alleges, was created as a replacement for first-generation anti-psychotic drugs that could be used in longer term treatment without many of the same risks. However, use of Geodon did produce side effects including, among other things, "weight gain, hyperglycemia, diabetes [and] cardiovascular complications."

At a time not specified in court records, the FDA gave Pfizer approval to make different formulations of Geodon. The purpose was for " the treatment of acute agitation in schizophrenic patients requiring rapid treatment…acute manic or mixed episodes of Bipolar I Disorder and/or…both schizophrenia and bipolar disorder."

Also at a time not specified in court records, the suit alleges Pfizer "illegally promoted Geodon for a variety of off-label purposes including, but not limited to, for use in pediatric patients and for higher than FDA-approved dosages." The suit also does not specify any instances of off-label use, including in West Virginia, or name health care professionals who may have participated in illegally promoting Geodon.

Nevertheless, the suit alleges state law was violated when "in the course of advertising, soliciting, selling, promoting and distributing" Pfizer "misrepresent[ed] Geodon's safety and efficacy."

Along with a permanent injunction prohibiting Pfizer from engaging in further "unfair or deceptive conduct" regarding Geodon, the attorney general is asking for $5,000 in civil penalties against Pfizer for each violation of the state Consumer Credit and Protection Act, and reimbursement of all costs the office incurs for bringing the suit. Representing the state of West Virginia is Kimberly Stitzinger Jones, an assistant attorney general in the office's consumer protection/antitrust division.

The case is assigned to Judge Charles E. King Jr.

Kanawha Circuit Court, case number 09-C-1681

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