Civil Action No. H-08-3408.

747 F.Supp.2d 745 (2010)

UNITED STATES of America, ex rel. Elaine BENNETT and Donald P. Boone, Plaintiffs, v. MEDTRONIC, INC., Defendant.

United States District Court, S.D. Texas, Houston Division.

September 30, 2010.

Attorney(s) appearing for the Case

David W. Sanford , Sanford Wittels et al., Washington, DC, Mitchell R. Kreindler , Kreindler & Associates, Mary Michelle Zingaro , Office of U.S. Attorney, Houston, TX, for Plaintiffs.

Stacy L. Brainin , Haynes and Boone LLP, Dallas, TX, Christopher P. Conniff , David J. Przygoda , Ropes & Gray, LLP, New York, NY, Michael K. Fee , Ropes & Gray LLP, Boston, MA, Samantha Barrett Badlam , Ropes & Gray LLP, Washington, DC, for Defendant.


LEE H. ROSENTHAL, District Judge.

This case raises the question of when a manufacturer's promotion of a medical device for an "off-label" use may provide the basis for a qui tam action by private plaintiffs suing under the False Claims Act.1 The relators, Elaine Bennett and Donald P. Boone, allege that Medtronic, Inc. improperly promoted its Cardioblate system device for an off-label use and that...

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