BIOTRONIK, Inc. Reaches Settlement with U.S. Department of Justice
LAKE OSWEGO, Ore., July 22, 2022 /PRNewswire/ -- BIOTRONIK SE & Co.KG, announced today that it has entered into a civil settlement with the U.S. Department of Justice, the U.S. Attorney's Office for the Central District of California, and the U.S. Department of Health and Human Services, Office of Inspector General, to resolve historical claims of alleged overuse of paid consultants to train field personnel and limited instances of excessive customer meals and travel. The Company denies all allegations on behalf of itself and its highly regarded physician partners, and the parties have agreed that the settlement is not an admission of liability.
The Justice Department and Inspector General acknowledged that the Company strengthened the compliance around its field personnel training program, added new compliance measures related to the provision of meals and travel provided to healthcare providers, imposed new restrictions, and improved training and oversight to identify and prevent meal and travel policy violations. Under the terms of the settlement, the Company will pay the United States and certain states $12.95 million USD to avoid the time and expense of further proceedings.
"The Company is pleased to put this investigation behind us so we can continue in our mission to deliver innovative solutions that save and improve patient lives every day," said BIOTRONIK Inc.'s President, Ryan Walters. "Our guiding principle, 'Excellence for Life,' is reflected in everything we do, including continuous enhancements to our culture of compliance. Acting responsibly with our customer and physician partners is paramount."
Since taking leadership of BIOTRONIK, Inc. in 2019, Mr. Walters has continued to improve the Company's internal compliance organization to ensure it keeps pace with the growth of the business.
"We are excited and proud of our proactive approach to compliance at BIOTRONIK. Our compliance program provides impactful guidance to our business operations and the implementation of cutting-edge internal controls, resulting in consistently thoughtful business practices," said VP of Compliance, Jason Spinazzola, J.D., M.P.H.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.
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