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US v. Eli Lilly and Company

US v. Eli Lilly and Company

Food & Drug Administration Criminal and Civil Cases:

December 21, 2005:

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:


Plea Agreement

Petition to Enter Plea of Guilty

Civil Complaint for Permanent Injunction

Consent Decree of Permanent Injunction



Consumer Protection
Civil Division
Updated October 23, 2014