Eli Lilly to pay $1.415B to resolve allegations of unapproved use of antipsychotic drug Zyprexa

WASHINGTON Drug maker Eli Lilly & Co. has agreed to pay $1.415 billion to resolve allegations that it promoted the antipsychotic drug Zyprexa for unapproved uses.

The Department of Justice announced Thursday that the Indianapolis-based company would pay a $515 million criminal fine - the largest ever in a healthcare case and the largest criminal fine ever imposed on an individual corporation - and up to $800 million in a civil settlement with the federal government and the states. It also will forfeit assets of $100 million.

The settlement will resolve criminal and civil allegations that Lilly promoted Zyprexa (olanzapine) for uses not approved by the Food and Drug Administration, including treatment of dementia in elderly people.

In a plea agreement, the company has admitted its guilt to a misdemeanor charge. It also signed a civil settlement to resolve claims that by marketing the drug for off-label uses, it caused the submission of false payment claims to federal health insurance plans such as Medicaid, TRICARE and the Federal Employee Health Benefits Program.