A settlement has been reached in a whistleblower class action lawsuit brought against Wyeth Pharmaceuticals Inc who is accused of marketing of the prescription drug Rapamune for uses not approved as safe and effective by the U.S. Food and Drug Administration (FDA). Rapamune is an “immunosuppressive” drug that prevents the body’s immune system from rejecting a transplanted organ. Wyeth was acquired by Pfizer Inc in 2009.
The settlement includes a criminal fine and forfeiture totaling $233.5 million. Under a plea agreement, which has been accepted by the U.S. District Court in Oklahoma City, Wyeth has agreed to pay a criminal fine of $157.58 million and forfeit assets of $76 million.
The resolution also includes civil settlements with the federal government and the states totaling $257.4 million. Of these amounts, Wyeth will pay $230,112,596 to the federal government and $27,287,404 to the states. The whistleblowers’ share of the civil settlement has not been resolved.
The government complaint (stemming from the orignally filed whistleblower case in December of 2005) alleged that Wyeth violated the False Claims Act, from 1998 through 2009, by promoting Rapamune for unapproved uses, some of which were not medically accepted indications and, therefore, were not covered by Medicare, Medicaid and other federal health care programs. These unapproved uses included non-renal transplants, conversion use (switching a patient from another immunosuppressant to Rapamune) and using Rapamune in combination with other immunosuppressive agents not listed on the label. The government alleged that this conduct resulted in the submission of false claims to government health care programs.
