The whistle blower lawsuit against Pfizer and its subsidiary Wyeth has now become a federal matter. The Department of Justice is continuing an ongoing crackdown on drug fraud by joining the case that alleges that Wyeth inappropriately marketed their drug Rapamune which, at the time, was only approved to prevent rejection for kidney transplant patients. The suit, brought on by two former employees, alleges that the company encouraged promotion of the drug for heart, lung, liver, and pancreas transplants in addition to its approved use for kidney transplant patients. Under current drug laws, doctors can prescribe medications for any use they see fit, but it is illegal for drug companies to market specifically for off-label uses.
Pfizer responded with a statement reminder that the lawsuit was filed in 2005, four years before the company purchased Wyeth. Pfizer also signed a corporate integrity agreement one year ago to agree to cease any off-label drug marketing. The agreement was in addition to a $2.3 billion settlement for off-label marketing of three other products.