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Pfizer Settles Kidney Transplant Drug Case for $491 Million | Legal News |


Drug company Pfizer has agreed to pay $491 million rather than face criminal and civil trials over accusations that it illegally marketed the kidney-transplant drug Rapamune for other types of transplants for which the drug was not approved.

The alleged misconduct involved Wyeth Pharmaceuticals, which Pfizer bought in 2009, and came to light when two employees blew the whistle on the company’s practices in a lawsuit.

Rapamune, which helps the body’s immune system acclimate to a transplanted organ, was approved by the Food and Drug Administration in 1999 for use in kidney transplants only.

The lawsuit accused Pfizer of aggressively marketing the drug for other types of transplants and offering its own salespeople financial rewards for expanding those markets.

The Department of Justice joined the lawsuit after Congress opened an investigation.

The $491 million settlement includes criminal fines and forfeiture of $233.5 million and civil fines of $257.4 million, and will be shared by the federal government, all 50 states and Washington, D.C.

After the settlement was announced, Pfizer said in a statement that it was not a target of the Justice Department, and that the company had “cooperated fully with the government from the time it learned of this investigation in October 2009. That cooperation was acknowledged today by the Justice Department.”

Attorney Reuben Guttman

But Reuben A. Guttman, a lawyer for the whistleblowers, called the company’s practices “shameful.”

“Everybody’s been asking me why this case is different than any other,” he told the New York Times. “We used to trust these companies. You can’t trust these companies anymore.”

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