US v. Eli Lilly and Company (Evista)

US v. Eli Lilly and Company (Evista)

Food & Drug Administration (FDA) (CLOSED)

12/21/05 Update:

American pharmaceutical manufacturer Eli Lilly and Company agreed to plead guilty and to pay $36 million in connection with its illegal promotion of its pharmaceutical drug Evista, the Justice Department announced on December 21, 2005. In pleading guilty to a criminal count of violating the Food, Drug, and Cosmetic Act by misbranding its drug Evista, the Indianapolis-based company agreed to pay a $6 million criminal fine and forfeit to the United States an additional sum of $6 million. In addition to the criminal plea, Lilly has agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into a Consent Decree of Permanent Injunction. As part of the Consent Decree, Eli Lilly agreed to pay $24 million in equitable disgorgement, and agreed to the entry of a permanent injunction. The criminal and civil cases were filed in the United States District Court for the Southern District of Indiana. The announcement was issued in a Press Release.

The following documents were filed with the District Court on December 21, 2005:

Information

Plea Agreement

Petition to Enter Plea of Guilty

Civil Complaint for Permanent Injunction

Consent Decree of Permanent Injunction

2/10/06 Update:

The United States District Court for the Southern District of Indiana, the Honorable Sarah Evans Barker, held a hearing on February 9, 2006. The Court accepted Eli Lilly's guilty plea to the Information. On February 10, 2006, the Court entered the Consent Decree of Permanent Injunction.