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Wyeth to pay $491 million to resolve multi-state, federal, off-label marketing lawsuit

By Bryan Cohen | Jul 31, 2013

NEW YORK (Legal Newsline) - New York Attorney General Eric Schneiderman announced Tuesday that New York joined a multi-state and federal settlement with Wyeth Pharmaceuticals Inc. to resolve allegations of off-label marketing of a kidney transplant drug.

New York joined 49 states, the District of Columbia and the federal government in the $491 million settlement that resolves criminal and civil allegations that Wyeth promoted the sale and use of Rapamune for uses not approved by the U.S. Food and Drug Administration. Rapamune is approved by the FDA to prevent the body from rejecting a transplanted donor kidney.

Wyeth allegedly improperly promoted Rapamune to healthcare providers for use with solid organ transplant patients other than kidney transplant patients and promoted the use of the drug in treatment regimens for transplant patients who used another immunosuppressant drug before using Rapamune. The FDA did not approve the use of Rapamune for such purposes.

"Illegally marketing drugs off-label puts patient lives at risk and rips off taxpayers by defrauding Medicaid and other programs," 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."

Under the terms of the agreement, Wyeth will pay the states and federal government $257.4 million in civil damages and penalties and $233.6 million in criminal fines and forfeitures. New York state's Medicaid program will receive $8,499,605.

The inquiry into Wyeth resulted from two whistleblower lawsuits filed in 2005 and 2007 under the federal False Claims Act and multiple state false claims acts.

In October 2009, Wyeth became a wholly-owned subsidiary of Pfizer. The off-label marketing and other conduct to which Wyeth pleaded guilty in federal court, occurred prior to Pfizer's acquisition of Wyeth.

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