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Attorney General J.B. Van Hollen Announces Agreement with Wyeth to Resolve Allegations Regarding Off-Label Marketing of Rapamune


MADISON — Attorney General J.B. Van Hollen announced today that Wisconsin 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, Pennsylvania, promoted the sale and use of Rapamune for uses for which it had not been approved by the FDA. Rapamune is a kidney transplant drug approved by the FDA to prevent the body from rejecting a donor organ that has been transplanted into the body.


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, including Wisconsin’s. The complaints alleged that Wyeth knowingly promoted the sale and use of Rapamune (a) for use in connection with solid organ transplant patients other than kidney transplant patients and (b) 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. More than $60 million of this amount will go to Medicaid programs.


Medicaid is a health insurance program for the needy and disabled jointly funded by the federal and state governments. The total portion of the settlement amount recovered by Wisconsin is $254,830.20.


The remaining amount is designated for other federal health care programs affected by Wyeth’s conduct. 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. (a Delaware corporation headquartered in New York City) 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.