FDAnews Drug Daily Bulletin

PFIZER SUED FOR ALLEGEDLY IMPROPER LIPITOR MARKETING

March 30, 2006
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Pfizer is facing a federal class action lawsuit alleging the company defrauded insurance plans and the federal government by improperly marketing its top-selling Lipitor.

In the suit, filed in the U.S. District Court for the District of New Jersey, several third-party drug plans contend Pfizer promoted the anti-cholesterol drug when lifestyle changes such as diet and exercise were the only recommended treatment. Pfizer also minimized and ignored the need for these lifestyle changes along with using the drug to treat high cholesterol, the plaintiffs assert.

Lipitor (atorvastatin calcium) is the highest-grossing prescription drug in the world, with sales expected to exceed $13 billion in 2006, according to Pfizer.

According to the lawsuit, health plans in Illinois, Ohio, Indiana, New Jersey and New York argue that Pfizer promoted Lipitor for uses not approved by the FDA, and that the company also used paid advocates purporting to be independent third parties to market those off-label uses to doctors.

This effort resulted in third-party drug and state Medicaid plans paying billions of dollars for unwarranted Lipitor prescriptions over the past five years, the groups argue.

"This is a classic case of unjust enrichment," said Jay Eisenhofer of Grant & Eisenhofer, the plaintiff's lead attorney. "Pfizer has built colossal sales of Lipitor through the pipeline of third-party payors such as our clients and countless other drug plans -- including Medicaid and Medicare -- much of it based on prescriptions that the FDA's guidelines say never should have been written in the first place."

The health plans want a court order enjoining Pfizer from continuing these marketing practices. The plans also are asking for compensatory and punitive damages based on Pfizer's alleged practices.

Pfizer said it is reviewing the case, but argued it "has and continues to take seriously its responsibility to provide appropriate information to physicians and patients and to comply with all federal laws and regulations regarding the promotion of our medicines."

Pfizer is not placing much credence in the class action claims. "Based on the information provided to us, we believe there is absolutely no merit to the claims regarding the promotion of Lipitor," said company spokesman Andrew McCormick. "Notably, other lawsuits filed by plaintiff lawyers regarding the marketing of Lipitor have -- after getting news attention -- have been dropped upon further investigation," he added.

(http://www.fdanews.com/did)