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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

he's been able to return millions of ill-gotten gains to taxpayers," said Brian J. McCormick, Esq., of Sheller, P.C. who also represents the relator/whistleblower.

Among the off-label promotion by Pfizer for Zyvox, according to the complaint:

  • Promoting Zyvox for the treatment of catheter related skin infections and concomitant bloodstream infections associated with catheter related skin infections. Zyvox's FDA approved labeling does not support this claim and it constitutes an off-label promotion.
  • Promoting Zyvox for the treatment of surgical site infections or as a prophylaxis for the prevention of surgical site infections. Zyvox's FDA approved labeling does not support this claim and it constitutes an off-label promotion.
  • Promoting Zyvox as clinically superior to vancomycin. Zyvox's FDA approved labeling does not support this claim and it constitutes an off-label promotion.
  • Promoting Zyvox as effective for all infections caused by MRSA including community acquired MRSA. Zyvox's FDA approved labeling does not support this claim and it constitutes an off-label promotion.
  • Promoting Zyvox as an appropriate choice "anywhere on the treatment continuum" regardless of the infection. Zyvox's FDA approved labeling does not support this claim and it constitutes an off-label promotion.
  • Promoting Zyvox as appropriate empiric therapy for all bacterial infections even though it has no effect on gram negative infections and only partial effect on polymicrobial infections. The promotion of Zyvox as appropriate empiric therapy for all infections constitutes an off-label promotion.

The government also discovered that Pfizer offered and paid illegal compensation to health care professionals to induce them to promote and prescribe Zyvox in violation of federal kickback laws.

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SOURCE Sheller, P.C. Law Firm
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