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FOR IMMEDIATE RELEASE
August 01, 2013
AG Ferguson, other Attorneys General, resolve unapproved marketing and misuse of kidney drug

Wyeth Pharmaceutical to pay $491M, Washington state will receive $261K

SEATTLE — Attorney General Bob Ferguson announced today that Washington has joined with other states and the federal government in a $491 million settlement against Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer Inc. in 2009.

In 1999, the U.S. Food and Drug Administration (FDA) approved Rapamune, an immunosuppressant drug that prevents the body from rejecting a transplanted organ, for kidney patients. The Attorneys General alleged that Wyeth violated the federal False Claims Act, from 1998 through 2009, by promoting Rapamune for other, unapproved uses.

Unapproved use included Rapamune for non-kidney organ transplants. Attorneys General asserted that Wyeth also pushed Rapamune treatment for kidney transplant patients who already used another immunosuppressant drug. This conduct resulted in false claims to government health care programs such as Medicare and Medicaid.

“Companies must comply with the FDA’s drug approval process,” said Ferguson. “This ensures their products are marketed for uses proven safe and effective. If a company chooses to put financial gain ahead of patient health, we will hold them accountable.”

Wyeth agreed to pay the states and the federal government a total of $491 million to resolve its criminal and civil liability from unlawful marketing of Rapamune.

Wyeth will pay $257 million in civil damages and penalties for unapproved marketing of Rapamune. Of this amount, $197 million will be returned to other federal health care programs affected by Wyeth’s conduct. The remaining $60 million will go to state Medicaid programs, which is funded jointly by the states and the federal government. Washington state will receive $260,917 to be used for Medicaid services and to combat Medicaid fraud.

Additionally, Wyeth pled guilty in federal court in Oklahoma to violations of the U.S. Food, Drug, and Cosmetic Act, and agreed to pay $234 million in criminal fines and forfeitures.

In late 2009, Pfizer Inc. acquired Wyeth. The conduct for 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.

Actions were filed in the U.S. 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.

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The Office of the Attorney General is the chief legal office for the state of Washington with attorneys and staff in 27 divisions across the state providing legal services to roughly 200 state agencies, boards and commissions. Attorney General Bob Ferguson is working hard to protect consumers and seniors against fraud, keep our communities safe, protect our environment and stand up for our veterans. Visit www.atg.wa.gov to learn more.


Contacts: Janelle Guthrie, Director of Communications, (360) 586-0725
Alison Dempsey-Hall, Dep. Communications Director, (206) 641-1335

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