The litigation related primarily to allegations that Celgene promoted Thalomid (thalidomide) for off-label uses before its 2006 FDA approval for newly diagnosed multiple myeloma.
The Department of Justice, the States, the District of Columbia, and the City of Chicago declined to intervene in the litigation.
Under the settlement, Celgene will pay a total of $280 million to the United States, 28 States, the District of Columbia, and the City of Chicago to resolve the litigation.
This final settlement includes the resolution of all allegations the Relator made with respect to Thalomid and Revlimid (lenalidomide).
Before the parties reached a settlement, the Court dismissed a significant part of the case on a motion for summary judgment, including allegations that Celgene illegally paid doctors to induce them to promote and/or prescribe Thalomid and Revlimid.
Celgene is not required to enter into a Corporate Integrity Agreement as part of the settlement.
Celgene has denied any wrongdoing in this matter, but is settling to avoid the uncertainty, distraction, and expense of protracted litigation.
Celgene contends, and has contended throughout the litigation, that Thalomid and Revlimid are medical breakthrough medicines that have benefitted patients with serious illnesses; that physicians prescribed these medicines based on their independent medical judgment; and that Celgene’s relationships with physicians have been appropriate, and have helped to advance patient care and science.