Pfizer Inc. ignored a 2005 FDA warning letter to stop promoting its antibiotic Zyvox@ as clinically superior to the significantly less expensive, generic vancomycin when its own FDA-approved label indicated otherwise. The drug giant also defrauded federal and state taxpayers by marketing Zyvox@ off-label, according to a qui tam whistleblower complaint filed by Sheller, P.C. attorneys and other documents unsealed with the September 1, 2009 $2.3 billion Pflzer settlement.

The $2.3 billion settlement included off-label marketing allegations for the withdrawn arthritis drug Bextra@, which was included in the Sheller complaint. Zyvox@ (linezolid) is an antibacterial agent that is approved by the FDA to treat certain types of infections, including nosocomial pneumonia and complicated skin and skin structure infections (“CSSSIs”) due to methicillin resistant Staphylococcus aureus (“MRSA”). Worldwide sales of Zyvox@ totaled $1.115 billion in 2008.

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, he’s been able to return millions of ill-gotten gains to taxpayers

The largest pharmaceutical qui tam settlement in history, the $2.3 billion settlement was announced today by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts.

Sheller, P.C. successful in additional qui tam lawsuits

Stephen A. Sheller, Esq., name partner of the Philadelphia firm, earlier this year represented a relator, the legal term for a whistleblower, in the largest single-drug whistleblower case in U.S. history when Eli Lilly & Company paid $1.4 billion to settle Zyprexa@ off-label marketing allegations. The Sheller firm’s lawyers have previously represented several other whistleblowers in successful lawsuits.

Approximately $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 ten times as much as the generic vancomycin.