Wyeth Pharmaceutical Agrees to Settle Off-Label Marketing Allegations

Wyeth Pharmaceutical, Inc., acquired by Pfizer, Inc. in 2009, has agreed to settle criminal and civil allegations concerning its marketing of the prescription drug Rapamune for off-label uses. According to the Justice Department, Wyeth will pay criminal penalties of $157.58 million and forfeit assets of $76 million. In addition, the company will pay $257.4 million to the federal government and the states to resolve the civil allegations.

Rapamune is an immunosuppressive drug that is used in transplant recipient patients to help keep their bodies’ immune systems from rejecting a transplanted organ. The Food and Drug Administration approved Rapamune for use in kidney transplant patients. According to two whistleblower lawsuits filed under the qui tam provisions of the False Claims Act, Wyeth trained its sales force to promote the use of Rapamune in all transplant patients, even non-kidney recipients, when it knew Rapamune had only been approved for use in kidney transplant patients.

The government claimed that Wyeth’s promotion of Rapamune for off-labels uses caused the submission of false claims to federal and state health care programs like Medicare and Medicaid. The Complaint alleged that Wyeth’s wrongdoing continued for over a decade – 1998 to 2009.

The whistleblowers, Marlene Sandler and Mark Campbell, two former Rapamune sales representatives, and pharmacist Scott Paris, are entitled to a portion of the settlement proceeds as their reward under the qui tam provisions of the False Claims Act.

Of the $27.28 million in settlement proceeds designated for payment to the states, Florida will receive $1.3 million for the false claims submitted to the state’s Medicaid program as a result of Wyeth’s alleged conduct.