Two Synthes Inc. Execs Enter Guilty Pleas

By Carmelina G. Allis –

We previously reported that Synthes, Inc., Norian Corporation, and four of Synthes’s executives had been charged by the United States government for allegedly violating several provisions of Titles 18 and 21 of the United States Code.  The defendants allegedly conducted clinical trials of medical devices without obtaining prior authorization from the Food and Drug Administration.  Now the New York Times and the Philadelphia Business Journal report that two Synthes executives, Michael D. Huggins and John J. Walsh, “pleaded guilty on Monday in federal court in Philadelphia to one misdemeanor count of shipping misbranded Norian XR across state lines.”  Mr. Huggins’s attorney issued a statement, indicating that his client’s guilty plea “‘is grounded in the principle that Mike Huggins was a responsible corporate officer at Synthes’ . . . Mr. Huggins has always made clear that he did not do anything knowingly or intentionally wrong.”  The attorney’s statement was likely made in reference to the Supreme Court’s 1975 decision in United States v. Park concerning responsible corporate officer liability.

Each defendant faces the possibility of one year in prison and a $100,000 fine.