What did Eli Lilly plead guilty to over Zyprexa?
Lilly paid $1.415 billion — including a then-record $515 million criminal fine — for promoting its antipsychotic Zyprexa for unapproved uses including treating dementia in elderly people, following four whistleblower lawsuits from former sales representatives.
In January 2009 Lilly agreed to plead guilty and pay $1.415 billion for promoting its antipsychotic Zyprexa for uses the FDA had not approved, including treating dementia and Alzheimer's dementia in elderly people. The resolution included a $515 million criminal fine, then the largest ever in a health care case, and up to $800 million in civil payments to federal and state programmes such as Medicaid.
The Justice Department said Lilly's management created marketing materials promoting off-label uses and trained its sales force to disregard the law. The case began with four whistleblower lawsuits by former sales representatives. Lilly pleaded guilty to a misdemeanour violation of the Food, Drug, and Cosmetic Act and entered a five-year corporate integrity agreement. It had by then also spent about $1.2 billion resolving 32,000 product-liability claims over Zyprexa.