Healthy Skepticism Library item: 15707

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Publication type: news

Hurtado P.
Pfizer Wins Dismissal of Lipitor False-Claims Lawsuit (Update2)
Bloomberg.com 2009 May 26
http://www.bloomberg.com/apps/news?pid=20601202&sid=a8DEY0DvbZIY&refer=healthcare

Full text:

Pfizer Inc., the world’s largest drugmaker, won dismissal of a false-claims lawsuit that alleged it illegally boosted sales through a campaign that misled doctors about its cholesterol pill Lipitor.

U.S. District Judge Edward Korman in Brooklyn, New York, granted the company’s request and ruled that a whistleblower suit failed to identify any doctor who viewed the alleged marketing materials promoting so-called off-label uses of the drug or any pharmacist who filled such a prescription.

“He has not identified any false claims or physicians who were induced to write a prescription for an off-label use,” Korman said in a ruling issued May 22.

The plaintiff, Jesse Polansky, can re-plead his complaint, Korman ruled. The judge denied a separate Pfizer request to dismiss Polansky’s claim that the company retaliated against him.

Polansky, a doctor and a former Pfizer director of outcomes management strategies, filed his complaint under seal in 2004 on behalf of the U.S., 16 states and the District of Columbia. The U.S. government chose not to join the lawsuit, Korman said in his ruling.

“The essence of his claim is that Pfizer advocated that Liptor be prescribed in cases in which its use was not recommended by the guidelines,” Korman said. “This is insufficient.”

‘Moderate’ Cholesterol

The suit claimed New York-based Pfizer pursued “an off- label marketing scheme” that sought to expand sales of Lipitor by advocating that doctors prescribe the pill to patients with moderately raised cholesterol levels. U.S. National Institutes of Health guidelines call for such patients to first try lifestyle changes in diet and exercise to lower cholesterol levels, Korman said.

Lipitor, whose generic name is atorvastatin, is a member of the statin class of drugs. Last year, Lipitor, which is the world’s best-selling drug, had $12.4 billion in sales.

Polansky worked on the marketing of Lipitor with the Pfizer team that evaluated and approved regulatory, legal and scientific integrity of the company’s major metropolitan markets. He claimed in the lawsuit that the drugmaker sought to “unlawfully broaden the patient population for which Lipitor is recommended.”

Voiced Concerns

The doctor said that in 2002 he began to investigate the Lipitor marketing program. In 2003, he said he raised concerns within the company that it was “being overly aggressive in marketing Lipitor.” Polansky said he was dismissed by Pfizer on Feb. 20, 2003, days after meeting with the company’s compliance unit.

Polansky claimed in his lawsuit that Pfizer’s off-label marketing scheme caused federal and state health programs to pay false or fraudulent claims for reimbursement for prescriptions of Lipitor other than those indicated on its label by using marketing themes such as “Get to Goal.”

Korman separately ruled that discovery will go forward on Polansky’s claim that he was retaliated against.

Christopher Loder, a spokesman for Pfizer, didn’t have an immediately comment on the decision. Steve Berman, a lawyer for Polansky, didn’t return a voice-mail message left at his office.

In 2006, Pfizer said its marketing practices were being investigated by federal prosecutors in Brooklyn. Robert Nardoza, a spokesman for Benton Campbell, the U.S. attorney in Brooklyn, declined to comment when asked if such an investigation was under way.

Pfizer rose 6 cents to $15.02 in New York Stock Exchange composite trading. The shares have fallen 15 percent this year.

The case is Ex Relator Jesse Polansky v. Pfizer Inc., 04-cv-0704, U.S. District Court, Eastern District of New York (Brooklyn).