Wyeth Pharmaceuticals Inc., owned by Pfizer, agreed to pay $490.9 million to in regards to criminal and civil liability for illegal marketing the drug Rapamune, according to a U.S. Department of Justice press release. Wyeth marketed and sold the drug for uses unapproved by the U.S. Food and Drug Administration.

Rapamune is used as an immunosuppressive, intended to protect transplanted organs in the body should the immune system attempt to reject the organs. As required by the Federal Food, Drug and Cosmetic Act (FDCA), pharmaceutical companies are required to indicate the intended uses in the FDA new drug application. In 1999, the FDA approved Rapamune to use in post-op renal (kidney) transplant patients.

“When companies like Wyeth are rushing to get a product to market, they often take advantage of gaps in the FDA’s protections,” commented Daniel Nigh, an attorney with the Levin, Papantonio law firm who practices in the areas of product liability and bad drug litigation. “For example, recently it came to light that the risks associated with Lipitor and Type-2 diabetes are greater than the company originally disclosed.” Pending investigations in the Lipitor lawsuit is currently researching whether the company knowingly distributed the drug without disclosing the risks associated with Lipitor and Type-2 diabetes. “Companies can rush their products through FDA approval processes, in certain situations, without fully vetting the potential dangers associated with their products,” Mr. Nigh concluded.

Wyeth was found, however, to have trained its Rapamune sales team to market and sell the drug outside of its approved use. Wyeth was able to get its national sales team to target outside the approved group though financial incentives.

Wyeth pleaded guilty to a misbranding violation under the FDCA. Under that charge alone, the company will have to pay criminal fines of up to $233.5 million. In a plea agreement accepted by the U.S. District Court in Oklahoma City, Wyeth will pay a criminal fine of $157.58 million and a $76 million forfeiture of assets. The company will also pay out over $250 million in part of a civil settlement with the federal government and the states Hyeth committed the crime.

Wyeth violated the False Claims Act by marketing Rapamune for unapproved uses, including non-medically accepted indications, some which weren’t covered by Medicare, Medicaid, and “other federal health care programs.”

The lawsuits were filed under the qui tam, or whistleblower, provisions of the False Claims Act. Former Rapamune sales representative Marlene Sandler and pharmacist Scott Paris filed the first action. Another sales person for Rapamune filed the second.

“Whistleblowers are essential in cases like this one,” said James Kauffman,  an attorney with the Levin, Papantonio law firm who represents whistleblowers under the False Claims Act, “Regulatory agencies can only do so much with their limited resources and whistleblowers give  regulators vital information that allow fraudsters to be brought to justice.”

Joshua de Leon is a writer and researcher with Ring of Fire.