United States of America v. Medtronic PLC

BACKGROUND

2 I. Factual Background1 3 The Court set out in detail the facts alleged by Relators John Birkle and Michael Bates on 4 behalf of the United States of America and the several States2 (“Relators”) in its prior Order 5 Granting Motion to Dismiss. ECF No. 51 (“MTD Order”). To briefly summarize, this qui tam action 6 concerns two medical devices manufactured by Defendant Covidien PLC (“Covidien”)3: (1) the 7 Puritan Bennett 980 Series Ventilator System (“PB 980”) and (2) the Vital Sync Informatics 8 Manager & Virtual Patient Monitoring Platform (“Vital Sync,” and collectively, the “Subject 9 Devices”). Although Covidien received clearance from the Food and Drug Administration (“FDA”) 10 for the devices in 2014, Relators allege they are defective and unreliable, and further allege that 11 Defendants gave kickbacks to hospitals to purchase these devices at government expense. 12 II. Procedural History 13 On December 30, 2019, Relators filed the instant qui tam action against Defendants. See 14 generally ECF No. 1. On April 28, 2021, Relators filed a First Amended Complaint under seal, 15 alleging forty-six (46) causes of action:…