Regarding a matter concerning the Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry, the company will make a payment of $13 million to resolve the DOJ’s investigation of the registry. The settlement is a compromise of disputed claims and Medtronic makes no admission that the STRATIS Registry was improper or unlawful.
Regarding a matter concerning various market-development and physician engagement activities conducted by legacy Covidien and ev3 Peripheral Vascular and endoVenous businesses, the company will make a payment of $20 million to resolve the DOJ’s investigation. The settlement is a compromise of disputed claims and Medtronic makes no admission that any of these activities were improper or unlawful.
These two settlements relate to historical conduct that began and largely concluded under legacy Covidien prior to Covidien LP and ev3, Inc. being acquired by Medtronic in 2015.
Regarding a matter concerning the Onyx Liquid Embolic System (Onyx), Medtronic-owned ev3 Inc. has agreed to plead guilty to a misdemeanor and make a payment of $17.9 million and adopt new compliance and reporting terms for a period of three years. The conduct at issue for the Onyx matter occurred between 2005-2009, and the government acknowledges that Medtronic and Covidien had no prior knowledge or involvement with any of the conduct that formed the basis of the charge. ev3 was purchased by Covidien plc in 2010. Medtronic, through its 2015 acquisition of Covidien, now owns ev3.
Medtronic is committed to maintaining the highest standards of ethical conduct and compliance with all applicable regulatory guidelines. The plea agreement and settlements that the Medtronic entities agreed to all concern matters that took place either largely or entirely prior to Medtronic acquiring the businesses in which the activities took place. Medtronic has made significant investments in ensuring that it fulfills its obligations to all of its stakeholders and to do business the right way.
It is also important to note that the government agrees that upon acquisition of Covidien and ev3, Inc. and without prompting or direction from the United States, Medtronic initiated additional compliance measures to prevent potential violations of the FDCA by ev3, Inc. and its employees.
Medtronic cooperated fully with the Department of Justice during its investigation, and we believe our ongoing, rigorous compliance programs and ethical practices enabled us to reach a fair resolution of these cases. We are pleased to put the matters behind us and will continue to fulfill our Mission to alleviate pain, restore health and extend life for millions of people around the world.