• Eli Lilly Settles Allegations of Off-Label Marketing of Zyprexa for Record $1.4 Billion
  • December 11, 2009
  • Law Firm: King & Spalding LLP - Atlanta Office
  • On January 15, 2009, the U.S. Attorney’s Office for the Eastern District of Pennsylvania announced the filing of a criminal information against Eli Lilly and Company (Eli Lilly or the Company) concerning the illegal marketing of its drug Zyprexa. The Government also announced the Eli Lilly’s plea agreement and a separate civil settlement agreement that resolved four qui tam lawsuits brought under the Federal False Claims Act (FCA). In total, Eli Lilly agreed to pay $1.415 billion, which the government described as “the largest amount paid by a single defendant in the history of the United States Department of Justice.”

    The information charges Eli Lilly with a misdemeanor violation of the Federal Food, Drug, and Cosmetic Act for introducing a misbranded drug into interstate commerce, in violation of 21 U.S.C. §§ 331(a), 333(a)(1), and 352(f)(1). FDA approved the Company’s drug Zyprexa for the treatment of schizophrenia and certain types of bipolar disorder. In its plea agreement, Eli Lilly admitted that it illegally marketed the drug for uses that were not approved by FDA. The information alleged that the Company improperly targeted physicians who treat elderly patients in assisted living facilities and primary care physicians. The sales force allegedly targeted the drug for use to treat “agitation, aggression, hostility, dementia, Alzheimer’s dementia, depression, and generalized sleep disorder,” none of which was approved by FDA.

    In its plea agreement, Eli Lilly agreed to pay a $515 million fine and $100 million in forfeiture. Pursuant to the separate civil settlement of FCA allegations, the Company will pay $438,171,543.58 to the United States and $361,828,456.42 to various state Medicaid programs. The whistleblowers will share in 18% of the federal share of the civil settlement, totaling $78,870,877. Additionally, the Company entered into a 5-year corporate integrity agreement with the HHS Office of Inspector General, which will require, among other things, disclosure of payments to doctors on Eli Lilly’s website.