United States v. Vascular Solutions, Inc. et al

Case Updates

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

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.