U.S. District Court for the Western District of Texas

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Case Updates

District court denies motion to dismiss off-label marketing prosecution case

November 16, 2015

The U.S. District Court for the Western of Texas denied the motion to dismiss the indictment.

U.S. Chamber files amicus brief

August 13, 2015

In its brief, the U.S. Chamber urged the U.S. District Court for the Western of Texas to dismiss the criminal indictment of a medical device manufacturer for promoting an “off-label” use of its product (i.e., a use other than the one for which FDA issued approval). The brief explains that the government’s theory of liability imposes a restriction on truthful speech about a lawful use based on both the identity of the speaker and the content of the message, which must be subject to heightened judicial scrutiny. The brief also argues that any attempt to explain the prosecution as a regulation of conduct rather than speech is merely post hoc rationalization of the government’s actions in this context, which have uniformly targeted speech rather than conduct.

Basheer Y. Ghorayeb, Michael A. Carvin, and David T. Raimer of Jones Day served as co-counsel for the U.S. Chamber of Commerce on behalf of the U.S. Chamber Litigation Center.

Indictment issued 11/13/2014.

U.S. Chamber amicus brief filed 8/13/2015.

Order denying motion to dismiss issued 11/16/2015.

Case Documents