Eli Lilly will pay about $1.42 billion after pleading guilty to criminal violations of the Food Drug and Cosmetic Act, and settling civil false claims actions with a number of qui tam relators, the United States, several states, and the District of Columbia.
The settlement arose out of allegations related to the marketing of Eli Lilly’s antipsychotic drug Zyprexa. Specifically, the government alleged that Eli Lilly instructed its sales force to promote the use of Zyprexa for the treatment of dementia although Zyprexa is not approved for such uses. This followed Eli Lilly’s abandoned effort to seek Food & Drug Administration approval for use of Zyprexa for dementia because of mixed clinical results and safety concerns.
Also, as part of the settlement, Eli Lilly has agreed to enter into a corporate integrity agreement with the Office of Inspector General of the United States Department of Health and Human Services. This agreement, in part, will require Eli Lilly’s corporate employees to certify annually that Eli Lilly is in compliance with Federal health care requirements. In addition, Eli Lilly must post on its website a list of physicians who receive payments from Eli Lilly for consultant or speaker services, along with the amount of money each such physician receives
