July 30, 2013
$491 million multi-state settlement reached with Montgomery County pharmaceutical company to resolve allegations of off-label marketing
HARRISBURG - The Pennsylvania Office of Attorney General today joined in a $491 million multi-state settlement to resolve civil and criminal allegations against a Montgomery County pharmaceutical company.
Attorney General Kathleen G. Kane said the company, Wyeth Pharmaceuticals, Inc., which is Delaware corporation headquartered in Collegeville, PA promoted the sale and use of Rapamune for uses that were not approved by the Federal Drug Administration (FDA.) Rapamune is a FDA approved kidney transplant drug, which is commonly prescribed to prevent the body from rejecting a donor organ that has been transplanted.
According to the complaint, Wyeth knowingly promoted the sale and use of Rapamune with solid organ transplant patients other than kidney transplant patients. Additionally, Wyeth allegedly promoted that Rapamune be used 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 more than $257 million in civil damages and penalties to resolve the civil allegations of off-label marketing. More than $60 million of this amount will go to the Medicaid programs, which are funded jointly by the states and the federal government. Pennsylvania will receive more than $1.4 million.
Additionally, Wyeth pled guilty in federal court in Oklahoma to violations of the U.S. Food, Drug and Cosmetic Act, and has agreed to pay more than $233 million in criminal fines and forfeitures.
Kane said 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.
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.
A team from the National Association of Medicaid Fraud Control Units (NAMFCU) conducted the settlement negotiations with Wyeth & Pfizer on behalf of the states and included representatives from the Offices of the Attorneys General for the states of Massachusetts, Virginia, Florida, Michigan and South Carolina.
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