Rapamune® Whistleblower Lawsuit Update: Justice Department to Join Pfizer

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U.S. Seeks to Join Pfizer Whistleblower Lawsuit

What’s the problem?

September 22, 2010 – According to recent court papers, the U.S. Justice Department is seeking to join a whistleblower lawsuit over Pfizer Inc.’s organ transplant drug Rapamune, alleging the medicine was illegally marketed. The government’s lawyers are asking a federal judge to allow them to take over litigating claims that officials of Pfizer’s Wyeth unit pushed the drug for unapproved uses and specifically targeted black patients.

Additionally, the whistleblowers claim Wyeth officials offered doctors and hospitals kickbacks – in the form of speaker fees and grants – in exchange for Rapamune prescriptions.

According to the complaint, Wyeth sales executives also targeted hospitals that served black populations in an effort to get doctors to switch transplant patients to Rapamune. The FDA required the drugmaker in 2004 to include a black-box warning on Rapamune about such patient conversions, which is the FDA’s highest safety warning.

Rapamune is approved to help prevent the rejection of kidney transplants. The U.S. Food and Drug Administration last year found the drug may increase the risk of death and organ rejection if given during a liver transplant.

The complaint was filed by Marlene Sandler and Scott Paris, two former Wyeth sales reps, who claim the drugmaker “directed their entire Rapamune sales force” to promote the drug among physicians involved in heart, lung, liver, and pancreas transplants. The drug hasn’t been approved for use in any of those transplants.

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