Life Science Compliance Update

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May 03, 2016

Peeling Back the Olympus Onion – The Importance of Culture

This article examines an apparent breakdown in corporate culture that goes beyond the subsidiaries to the parent company, Olympus Corporation. It is a cautionary tale for life science compliance officers on the importance of corporate culture's impact on successful (or in this case unsuccessful) compliance.

With the recently announced settlements by Olympus Corporation of the Americas (OCA) and Olympus Corporation of Latin America (OLA), the size of the civil and criminal penalties ($646 million) represent the largest penalties imposed on a medical device manufacturer. Also with the settlements involving conduct violating three statutes, the Foreign Corrupt Practices Act, the Anti-Kickback Statute (AKS), and the False Claims Act (FCA), it is no surprise that corporate culture and the "tone from the top" are hot topics of conversation among life sciences professionals.

Cultural issues certainly are at the heart of the complaint brought by John Slowik, the whistleblower in the case. According to his story, Slowik was a twenty-plus year veteran of OCA, who as Chief Compliance Officer for OCA became the victim of retaliatory acts for his efforts to create an effective and efficient compliance program. OCA ultimately fired Slowik. He alleged that he was unsuccessful in part because of what "seemed to be a system of actions [involving non-compliance] long in practice."   

Read the entire story in the May Issue of Life Science Compliance Update - Now Available.

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