Eli Lilly and Company has agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa for uses not approved by the Food and Drug Administration (FDA), according to the U.S. Department of Justice.
Four separate lawsuits were brought under the qui tam provisions of the False Claims Act, alleging that Lilly marketed its antipsychotic drug Zyprexa for uses that had not been approved by the FDA. The promotion of these off-label uses caused false claims for payment to be submitted to federal insurance programs such as Medicaid, TRICARE and the Federal Employee Health Benefits Program, none of which provided coverage for such off-label uses.
The $1.415 billion includes a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind. Eli Lilly will also pay up to $800 million in a civil settlement with the federal government and the states.