DOJ to Intervene in Rapamune Whistleblower Lawsuit Against Pfizer

The federal government and a number of states have decided to intervene in a whistleblower lawsuit that accuses Pfizer’s Wyeth unit of giving kickbacks to doctors to encourage them to prescribe Rapamune, as well as promoting the organ transplant drug for off-label uses. 

The Rapamune whistleblower lawsuit was first filed in 2005 by two sales representatives who said that Wyeth, which was acquired by Pfizer last year, gave cash and incentives to doctors to prescribe the immunosuppressant, which can cost patients up to $20,000 per year. On Tuesday, the Department of Justice (DOJ) filed a motion in U.S. District Court in Philadelphia, along with 19 states and the District of Columbia.

The DOJ and states have asked the court to allow them to take part in the lawsuit, saying that Wyeth defrauded the government of Medicare and Medicaid payments through its actions with Rapamune.

Rapamune (sirolimus) is an immunosuppressant that prevents the body from rejecting organs after transplant surgery. The drug generated $376 million in sales in 2008.

It is most often used in kidney transplants for hemolytic-uremic syndrome, which can reoccur in a transplanted kidney. However, the drug is also commonly prescribed off-label for liver transplants as well. It is illegal for drug companies to promote medications for off-label uses, even though doctors can prescribe approved medications for any purpose they feel is appropriate.

The sales representatives who launched the whistleblower suit said that the company specifically targeted hospitals with large populations of African American patients, despite the fact that they are considered high-risk patients. Pfizer has said that African Americans were never contraindicated for Rapamune. In June, the House Oversight and Government Reform Committee announced it was launching an inquiry into whether Wyeth’s Rapamune promotions were specifically targeted toward African Americans.

Whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

Last year, Pfizer agreed last year to pay $2.3 billion to settle charges that it illegally marketed the painkiller Bextra and other drugs. That settlement included the largest criminal fine in U.S. history, $1.195 billion. The fine was specifically for off-label promotion charges.