The federal government wants to intervene in a whistleblower lawsuit against Pfizer Inc. involving its organ transplant drug, <"http://www.yourlawyer.com/practice_areas/defective_drugs">Rapamune. The whistleblower lawsuit alleges Pfizer’s Wyeth unit marketed Rapamune for unapproved uses and targeted black patients.
Rapamune (sirolimus) is approved to prevent organ rejection in patients aged 13 years or older receiving kidney transplants. Last June, the US Food & Drug Administration (FDA) warned that Rapamune may be linked to an increased risk of death when taken by liver transplant recipients. The agency has never approved Rapamune for that use, and pointed out in its warning that the safety and efficacy of Rapamune in liver or lung transplant patients have not been established by the FDA.
Doctors are free to prescribe drugs for off-label uses, but drug companies are legally barred from promoting such uses.
According to a Bloomberg News report, the Rapamune whistleblower lawsuit was filed in 2005 by Marlene Sandler and Scott Paris, two former Wyeth sales reps, who claim the drug maker â€œdirected their entire Rapamune sales forceâ€ to promote the drug among physicians involved in heart, lung, liver and pancreas transplants. The lawsuit also claims that Wyeth officials offered doctors and hospitals kickbacks in exchange for Rapamune prescriptions, and targeted hospitals that served black populations in an effort to get doctors to switch transplant patients to Rapamune.
The alleged off-label promotion caused false reimbursement claims to be submitted to government health programs, the lawsuit said.
The whistleblower provisions of the False Claims Act allow private citizens to bring lawsuits on behalf of the federal government and share in any recovery. The law was designed to encourage people with knowledge of suspected wrongdoing to come forward.