Attorney General Sam Olens announced today that Georgia has joined with other states and the federal government in a $491 million dollar settlement to resolve civil and criminal allegations that Wyeth Pharmaceuticals, Inc. (Wyeth), a Delaware corporation headquartered in Collegeville, Pa., promoted the sale and use of Rapamune for uses for which it had not been approved by the Federal Drug Administration (FDA). Rapamune is a FDA approved kidney transplant drug which is prescribed to prevent the body from rejecting a donor organ that has been transplanted into the body. The total portion of the settlement amount recovered by Georgia is $540,498.11.
The investigation resulted from qui tam actions filed in the United States District Courts for the Eastern District of Pennsylvania and the Western District of Oklahoma under the federal False Claims Act and various state false claims statutes. The complaints alleged that Wyeth knowingly promoted the sale and use of Rapamune for use in connection with solid organ transplant patients other than kidney transplant patients and in treatment regimens with transplant patients who used another immunosuppressant drug before using Rapamune and who did not receive Rapamune at or around the time of a kidney transplant.
Wyeth has agreed to pay the states and the federal government $257.4 million in civil damages and penalties to resolve the civil allegations of off label marketing of Rapamune. Over $60 million dollars of this amount will go to the Medicaid programs, which are funded jointly by the states and the federal government. Additionally, Wyeth has pled guilty in federal court in Oklahoma to violations of the U.S. Food, Drug, and Cosmetic Act, and has agreed to pay $233.6 million in criminal fines and forfeitures.
In late 2009 Pfizer Inc. acquired Wyeth. The off label marketing and the conduct to which Wyeth pled guilty occurred prior to Pfizer’s acquisition of Wyeth. Pfizer cooperated fully with the federal government and the states in the investigation.