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International Medical Device Maker; Four Executives Charged in Connection With Unlawful Clinical Trials
Date:6/16/2009

PHILADELPHIA, June 16 /PRNewswire-USNewswire/ -- United States Attorney Michael L. Levy and Acting Assistant Attorney General Michael F. Hertz today announced the return of an indictment(1.) against Norian Corporation (Norian), Synthes, Inc. (Synthes), and four top Synthes executives, Michael D. Huggins (Huggins), Thomas B. Higgins (Higgins), Richard E. Bohner (Bohner) and John J. Walsh (Walsh), charging them for their involvement in conducting clinical trials of a medical device without the authorization of the FDA. Joining in today's announcement were Food and Drug Administration (FDA) Office of Criminal Investigations Special Agent-in-Charge Kim A. Rice; Department of Health and Human Services (HHS) Office of Inspector General Office of Investigations Special Agent-in-Charge Patrick Doyle; Defense Criminal Investigative Service (DCIS) Special Agent-in-Charge Edward Bradley; and Department of Veterans Affairs (VA) Special Agent-in-Charge Jeffrey G. Hughes, Northeast Field Office, Office of Inspector General.

The indictment charges Norian with a total of 52 felony counts: conspiracy to impair and impede the lawful functions of the FDA and to commit crimes against the United States; seven counts of making false statements in connection with an FDA inspection; and 44 counts of shipping adulterated and misbranded Norian XR in interstate commerce with intent to defraud. The parent company, Synthes, is charged with 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce, and the four executives, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh, are each charged with one misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce. As explained below, these crimes allegedly prevented the FDA from carrying out its role of supervising clinical trials of significant risk devices, and deprived patients of the safeguards provided by FDA oversight of clinical tr
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SOURCE U.S. Department of Justice
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