Philadelphia, Pennsylvania— Multiple news publications have confirmed that Eli Lilly & Co. will, in the largest United States-imposed criminal fine on an individual company, pay $1.42 billion for the off-label marketing of its drug Zyprexa. This record-breaking false claims case settlement was announced on January 16 by Acting U.S. Attorney Laurie Magid and Attorney General Michael Mukasey. Lilly will reportedly make its guilty plea in the U.S. District Court of Philadelphia within the next few weeks.
The 10th largest pharmaceutical company in the world, Eli Lilly & Co. admitted to off-label use of Zyprexa; specifically, the organization promoted the drug for dementia in elderly populations, a usage that was not approved by the Food and Drug Administration. Additionally, Lilly trained its sales force to disregard the law by promoting Zyprexa for off-label uses. Thus over a period of two years (September 1999-March 2001), Lilly earned “hundreds of millions of dollars” through consistent criminal violations of the Food, Drug, and Cosmetic Act.
Of the civil settlement, $438 million will go to the federal government and up to $362 million will be allocated to states included in the settlement. As a component of its restitution, Lilly will undergo five years of U.S. monitoring against future lawbreaking. Independent from the current settlement, the company also faces lawsuits across twelve states for improper and off-label drug marketing.
This monumental case was initiated by Lilly sales representatives who in 2003 filed complaints against Lilly under the terms of the federal False Claims Act. For their actions, the whistleblowers will receive over $78 million— or 18 percent of the settlement— in addition to possible shares of state settlements.