Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations
of Off-label Promotion of Zyprexa
$515 Million Criminal Fine Is Largest Individual Corporate Criminal Fine in History; Civil
Settlement up to $800 Million
American pharmaceutical giant Eli Lilly and Company today 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), the Department of
Justice announced today. This resolution 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.
Eli Lilly agreed to enter a global resolution with the United States to resolve criminal and civil allegations that
it promoted its antipsychotic drug Zyprexa for uses not approved by the FDA, the Department said. Such
unapproved uses are also known as "off-label" uses because they are not included in the drug’s FDA approved
Assistant Attorney General for the Civil Division Gregory G. Katsas and acting U.S. Attorney for the Eastern
District of Pennsylvania Laurie Magid today announced the filing of a criminal information against Eli Lilly for
promoting Zyprexa for uses not approved by the FDA. Eli Lilly, headquartered in Indianapolis, is charged in the
information with promoting Zyprexa for such off-label or unapproved uses as treatment for dementia, including
Alzheimer’s dementia, in elderly people.
The company has signed a plea agreement admitting its guilt to a misdemeanor criminal charge. Eli Lilly also
signed a civil settlement to resolve civil claims that by marketing Zyprexa for unapproved uses, it 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.
Department of Justice document is here.
A deep bow of respect to investigative journalist Philip Dawdy, without whose dedication and personal sacrifices this result might never have been reached. Visit him at Furious Seasons.