Illegal Rapamune Marketing Leads to $491M Whistleblower Settlement

Pfizer’s Wyeth unit has agreed to pay $490.9 million to settle a whistleblower lawsuit that accused the company of illegally marketing the immunosuppressive drug Rapamune, alleging that the company was specifically targeting health care facilities frequently used by African Americans.  

Although Rapamune is only approved for short-term use for kidney transplant patients, the allegations claim Wyeth promoted the drug for additional uses that were never determined to be safe or effective by the FDA, according to a Justice Department press release.

The charges indicated that the drug maker deliberately targeted Einstein Medical Center in Philadelphia and SUNY Downstate Medical Center in New York because they served large African American populations, promoting Rapamune for non-kidney transplants and trying to get patients to switch from other immunosuppressants to Rapamune.

Wyeth has plead guilty to the criminal charges and paid a criminal fine of $233.5 million and a civil settlement of $257.4 million.

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.

Former Employees Brought Whistleblower Suit

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.

The allegations were originally brought by former Wyeth sales representatives and a pharmacist. Wyeth officials believed that data indicated that the immune systems of African Americans had a stronger response to organ transplants than other groups. The charges led to a congressional investigation in 2010.

The two lawsuits brought in the case claim the company trained its sales force to illegally promote Rapamune and gave them training materials on how to do so.

“The FDA approved Rapamune for limited use in renal transplants and required the label to include a warning against certain uses. Yet, Wyeth trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales,” said Sanford Coats, U.S. Attorney for the Western District of Oklahoma. “This was a systemic, corporate effort to seek profit over safety.”

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.