Drug maker Eli Lilly & Company agreed Thursday to pay federal and state governments more than $1.4 billion for its improper off-label marketing of Zyprexa, a popular schizophrenia medicine. Lilly will pay $800 million to settle civil charges, while $515 million will be paid as part of a guilty plea to a misdemeanor violation of the Food, Drug and Cosmetic Act. The Department of Justice called it the largest corporate criminal fine in history.
The pharmaceutical giant marketed the drug to treat disruptive children and Alzheimer's disease in seniors, even though the Food and Drug Administration only approved Zyprexa for schizophrenia and a certain type of bipolar disorder. In fact, the medicine caused increased risk for heart failure and pneumonia in seniors and weight gain and diabetes in children.
Six whistleblowers, former Lilly employees who brought the complaint, will share approximately 18 percent of the settlement. In the complaint, they alleged Lilly illegally pushed off-label use of the drug with tactics that included planting employees to ask questions at lectures and conferences and downplaying the risk of diabetes from using Zyprexa with a video that cited scientific studies of "questionable integrity."
As part of the settlement, Lilly does not admit to the civil allegations.
"Every day and with every interaction we strive to operate in a responsible and compliant manner," said Lilly's chairman, president and CEO, John Lechleiter, in a statement. "Doing the right thing is non-negotiable at Lilly, and I remain personally committed to all of us at Lilly maintaining the highest standards of conduct."