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US v. Eli Lilly and Company (Evista)

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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:


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.


Consumer Protection
Civil Division
Updated October 24, 2014