Tuesday, March 23, 2010

Pfizer - Neurontin: "a good drug marketed by some bad people"

March 23 (Bloomberg) -- Pfizer Inc., facing a $300 million fraud claim, defended its epilepsy drug Neurontin at the close of a civil racketeering trial in Boston.

“It’s a good drug that, at one time, at least in some parts of the country, may have been marketed by some bad people,” Pfizer attorney Raoul Kennedy told jurors in a closing argument today.

Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals claimed in a monthlong trial in federal court that Pfizer illegally promoted Neurontin for unapproved uses. Kaiser said it was misled into believing Neurontin was effective for migraines, bipolar disorder and other conditions in addition to epilepsy, for which the U.S. Food and Drug Administration approved the drug in 1993.

Kaiser doctors continued to prescribe the drug in growing quantities even after the health insurer filed suit against Pfizer in 2005, Pfizer lawyers told the jury. The insurer’s Web site also continues to list Neurontin as a drug for neuropathic pain, they said.

“What you’re hearing in this courtroom is not what Kaiser is telling its patients,” Pfizer attorney James E. Hooper said during closing arguments.

$100 Million Sought

Kaiser, the first insurer to try a Neurontin case against Pfizer, is seeking $100 million, an amount that may be tripled under federal civil-racketeering law.

Kaiser, based in Oakland, California, alleges Neurontin was wrongly prescribed for off-label uses, including treatment of neuropathic pain, and in dosages larger than the maximum approved by the FDA. The company’s own studies showed that Neurontin was no more effective than a placebo in treating the condition, though Pfizer never told doctors or patients about the findings.

Pfizer claims Kaiser continues to permit its doctors to prescribe Neurontin for off-label conditions. Kaiser didn’t present testimony from any doctors claiming they wouldn’t have prescribed the medication if they had known better, Pfizer’s lawyer argued.

“This is a plaintiff who has 12,000 supposedly defrauded doctors and hasn’t brought one in here,” Kennedy told the jury.

Kaiser Arguments

Kaiser was presenting closing arguments this afternoon, after which jurors will begin their deliberations.

The trial began Feb. 22 with jury selection under the supervision of U.S. District Judge Patti Saris, who is overseeing federal lawsuits from throughout the U.S. targeting Pfizer with injury claims and allegations of fraudulent sales and marketing of the drug.

A verdict in the case may influence other Neurontin suits against Pfizer, the world’s largest drugmaker. In a ruling last year, Saris said that fraud findings against Pfizer could be binding against the New York-based company in future trials.

Like other third-party payers suing Pfizer, the health insurer claims it would have saved money spent on off-label Neurontin prescriptions if Pfizer hadn’t hidden the truth.

Warner-Lambert Co. developed and marketed Neurontin for several years before Pfizer acquired the company in 2000. Four years later, Warner-Lambert pleaded guilty and agreed to pay $430 million to resolve off-label marketing allegations by the U.S. Justice Department.

‘Academy Awards’

The Justice Department claimed in a 2004 sentencing memorandum that Warner-Lambert’s marketing increased off-label sales from 15 percent of all Neurontin prescriptions in 1994, its first year on the market, to 94 percent, or $2.12 billion, of Pfizer’s Neurontin sales in 2002.

“This is not the FDA proceeding. We lost that one,” Pfizer attorney Kennedy said. “But off-label marketing is not fraud.”

He also suggested Kaiser deserves no damages because they passed the drug costs on to customers by hiking premiums.

“Is Kaiser like those people who come to the Academy Awards and accept for someone who can’t be there?” he asked. “Except Kaiser wants to keep the statue for itself.”

In 2002, responding to press reports of Pfizer’s allegedly fraudulent Neurontin marketing, Kaiser began an information campaign that led to a 34 percent drop in Neurontin prescriptions to its members, according to Saris.

Among the cases in Saris’s court are product-liability suits claiming the drug is linked to an increased risk of suicide. The first trial in one of those cases, over the suicide death of a 39-year-old woman, ended when her family dropped the case.

In January, Saris dismissed fraud claims by Aetna Inc. and Guardian Life Insurance Co. against Pfizer. Unlike those companies, Kaiser showed it had considered Pfizer’s allegedly false claims and data in deciding to pay for off-label Neurontin prescriptions, Saris ruled before the trial.

The case is In re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629, U.S. District Court, District of Massachusetts (Boston).

To contact the reporters on this story: Bob Van Voris in New York at rvanvoris@bloomberg.net; Janelle Lawrence in Boston at rvanvoris@bloomberg.net.

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