Pharmaceutical Giant To Pay Nearly $500 Million To Resolve Allegations Of Off-label Marketing Of Kidney Transplant Drug

Wyeth Pharmaceutical Will Pay NYS $8.5 Million Of Total For Improperly Marketing Rapamune

Schneiderman: My Office Will Protect Taxpayer Dollars And New York Patients From Illegal Marketing Of Pharmaceutical Drugs

NEW YORK – Attorney General Eric T. Schneiderman today announced that New York joined 49 states, the District of Columbia and the federal government in a $491 million settlement agreement resolving civil and criminal allegations that Wyeth Pharmaceuticals, Inc., promoted the sale and use of Rapamune for uses not approved by the U.S. Food and Drug Administration. Rapamune is an FDA-approved kidney transplant drug that is prescribed to prevent the body from rejecting a transplanted donor organ.

“Illegally marketing drugs off-label puts patient lives at risk and rips off taxpayers by defrauding Medicaid and other programs,” Attorney General Schneiderman said. “Pharmaceutical companies, no matter how large, are not above the law, and my office will continue to ensure that prescriptions are written based on sound medical judgment.”

Wyeth, a Delaware corporation headquartered in Collegeville, Pennsylvania, agreed to pay the states and the federal government $257.4 million in civil damages and penalties to compensate Medicaid, Medicare and various other federal healthcare programs. 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 $233.6 million in criminal fines and forfeitures. Over $60 million of the civil settlement will go to state Medicaid programs, which are funded jointly by the states and the federal government. New York State’s Medicaid program will receive $8,499,605. The remaining $197,266,067.00 is designated for other federal health care programs affected by Wyeth’s conduct. 

The investigation resulted from two whistleblower lawsuits filed in 2005 and 2007 in the United States District Courts for the Eastern District of Pennsylvania and the Western District of Oklahoma, respectively, under the federal False Claims Act and various state false claims acts, including the New York False Claims Act. The complaints alleged that Wyeth improperly promoted the sale and use of Rapamune to healthcare providers in connection with solid organ transplant patients, other than kidney transplant patients. They further alleged that the company promoted the drug’s use in treatment regimens for 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. The FDA had not approved the use of Rapamune for these purposes.

In October 2009, Wyeth became a wholly-owned subsidiary of Pfizer, a Delaware corporation headquartered in New York City. The off-label marketing, and the conduct to which Wyeth pled guilty, occurred before Pfizer’s acquisition of Wyeth. 

For New York State, this matter was handled by Special Assistant Attorney General Carolyn Ellis of the Attorney General’s Medicaid Fraud Control Unit; then-Special Assistant Attorney General Randall Fox; Computer Programmer Analyst Nicholas Furnari; then-Associate Special Auditor/Investigator Edward J. Keegan, Jr.; and Lawrence Logan, Director of the Electronic Investigative Support Group; under the supervision of Assistant Chief Auditor Michael LaCasse, MFCU Deputy Attorney General Monica Hickey-Martin and Executive Deputy Attorney General for Criminal Justice Kelly Donovan.

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