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Sheller, P.C. Law Firm Instrumental in Pfizer's $2.3 Billion Settlement Today in Largest Pharmaceutical Whistleblower Case in History
Date:9/2/2009

oximately $4.4 billion worth of Pfizer's Zyvox was sold from 2000 to 2008, according to the company's annual reports. Explosive sales increases averaged close to 200 percent per year. They also caused public health concerns of drug resistance and immunity, according to court and public documents.

"The widespread off-label promotion of Zyvox by Pfizer for non-FDA approved purposes poses a grave public risk because it increases the risk that linezolid resistant eterococci will develop and also increases the risk that more Zyvox resistant bacterial strains will develop," according to Sheller's complaint.

In a 2007 letter to physicians, the New York State Health Department warned that, "Overuse of [Zyvox] will accelerate the development of resistance and limit its overall effectiveness."

"Let's hope this case helps put the brakes on the overuse of Zyvox so the New York State Health Department's warning doesn't come true and patients can continue to be treated effectively for the specific uses for which this drug is effective and approved," said James J. Pepper, Esq., of Sheller, P.C. who also represents the relator.

In its July 2005 Warning Letter, the FDA stated that Pfizer's ad misbranded Zyvox, made misleading and unsubstantiated implied superiority claims, and omitted important safety information. Although it paid lip service to the FDA in response to the letter, Pfizer continued to make claims to physicians that Zyvox was superior to vancomycin, according to Pepper. Zyvox costs approximately tens times as much as the generic vancomycin.

"Our client had a tremendous amount of information about the illegal marketing behind Zyvox that proved invaluable in making the case. We investigated his allegations and then filed a complaint under seal in federal court. As a result of what he observed and the careful cooperation our office had with federal and state authorities,
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SOURCE Sheller, P.C. Law Firm
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