Amgen Inc. pleaded guilty in a federal court in New York on Tuesday to misbranding its Aranesp anemia drug and agreed to pay $762 million in a civil settlement and criminal fines. Amgen will not lose any federal business or contracts.
The case focused on Amgen’s off-label marketing campaign and use of illegal kickbacks to promote the sale of Aranesp, which is used to treat anemia caused by kidney disease or by cancer chemotherapy. According to the lawfirm that lead the case against Amgen, Sanford Heisler, LLP, the federal investigation confirmed that the company’s tactics caused physicians to use the company’s medications unnecessarily in circumstances where less costly medications or no medication would otherwise have been used. These and other fraudulent practices resulted in increased costs incurred by Medicare and Medicaid for the treatment of patients improperly prescribed Aranesp and other Amgen medications.
Amgen was accused of promoting Aranesp for anemia caused by cancer, for which it was not approved, rather than to combat anemia as a side effect of chemotherapy treatments, Reuters reported.
The legal team at Sanford Heisler LLP included Lead Counsel David Sanford, Grant Morris and Stefanie Roemer in the firm’s Washington, D.C. and Ross Brooks in the firm’s New York offices.
“This settlement reflects several years of investigative effort, in collaboration with the U.S. Department of Justice and the U.S. Attorney’s Office,” said lead counsel David Sanford. “The DOJ and United States Attorney did an outstanding job of validating our allegations. We are pleased with this outcome and believe it will go a long way in preventing Amgen from continuing to violate federal regulations by promoting the off-label use of its powerful drugs and providing medical providers with kickbacks for inappropriately prescribing them. This settlement will also empower pharmaceutical sales representatives to blow the whistle on their employers’ illegal actions.”