US Ex Rel. Bennett v. Medtronic, Inc.

MEMORANDUM AND OPINION

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 tarn 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 the promotional activities caused physicians and hospitals to submit false claims for reimbursement from Medicare or Medicaid. The FDA has approved the Cardioblate system for…