(COLUMBUS, Ohio) - Ohio Attorney General Mike DeWine announced today that Ohio has joined with other states and the federal government in a settlement of $491 million to resolve civil and criminal allegations that Wyeth Pharmaceuticals, Inc. promoted the sale and use of the drug Rapamune for uses for which it had not been approved by the U.S. Food and Drug Administration (FDA).
“Rapamune is a kidney transplant drug used to prevent the body from rejecting a donor kidney, but investigators found that Wyeth knowingly promoted the sale and use of the drug for use in connection with other types of organ transplants,” said Attorney General DeWine. “This settlement shows that pharmaceutical companies will be held accountable for unlawfully promoting their products.”
The investigation resulted from whistle-blower 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.
Wyeth has agreed to pay the states and the federal government $257,400,000 in civil damages and penalties to resolve the civil allegations of off label marketing of Rapamune. Over $60 million of this amount will go to the Medicaid programs, which is funded jointly by the states and the federal government. The total portion of the settlement amount recovered by Ohio is $2,569,222.60. The remaining $197,266,067 is designated for other federal health care programs affected by Wyeth’s conduct.
Additionally, Wyeth has pleaded guilty in federal court in Oklahoma to violations of the U.S. Food, Drug, and Cosmetic Act, and has agreed to pay $233,600,000 in criminal fines and forfeitures.
A team from the National Association of Medicaid Fraud Control Units (NAMFCU) conducted the settlement negotiations with Wyeth and Pfizer, which acquired Wyeth in 2009. The off label marketing, and the conduct to which Wyeth pleaded guilty, occurred prior to Pfizer's acquisition of Wyeth.
Dan Tierney: 614-466-3840
Jill Del Greco: 614-466-3840