OtisMed, Ex-CEO Cop To Distributing Device After FDA Denial

Law360, New York (December 8, 2014, 6:51 PM EST) -- Stryker Corp.'s OtisMed unit will pay more than $80 million to resolve criminal and civil claims in New Jersey that it distributed knee replacement surgery devices without proper federal clearance — allegations that have also led to the guilty plea of OtisMed's former chief executive officer, prosecutors announced Monday.

U.S. Attorney for the District of New Jersey Paul Fishman and other federal officials announced the guilty pleas of OtisMed and former CEO Charlie Chi over the intentional shipping of OtisKnee orthopedic cutting guides in September 2009 after the U.S. Food and Drug Administration denied the company's 501(K) application for permission to...

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