PHILADELPHIA - United States Attorney Michael L. Levy and Acting Assistant Attorney General Michael F. Hertz 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 the 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; 7 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 trials.

According to the indictment, Synthes, a Delaware corporation based in West Chester, Pennsylvania, is the United States branch of a large multinational medical device manufacturer which specializes in trauma products to treat damaged human bone. Norian, it is alleged, is a wholly owned subsidiary of Synthes, specializing in the manufacture of osteobiologic medical devices, with a principal place of business in West Chester, Pennsylvania.

Defendant Huggins was allegedly employed by Synthes as the President of Synthes North America, a subsidiary of Synthes. It is alleged that in February 2004, Huggins became the President of Synthes Spine, a division of Synthes. Defendant Higgins was allegedly the President of Synthes Spine, a division of Synthes, reporting to Huggins. In February 2004, Higgins allegedly left that position and became Synthes's Senior Vice President of Global Strategy. The indictment alleges that defendant Bohner was employed by Synthes as its Vice President of Operations, reporting to Huggins. Defendant Walsh was allegedly employed by Synthes starting in August 2003 as its Director of Regulatory and Clinical Affairs, Spine Division, and reported first to Bohner and later to Huggins.

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