Synthes, Inc. (Synthes) executives, Michael D. Huggins and John J. Walsh pleaded guilty for their role in the company’s illegal trials of bone-mending cement that led to the deaths of three patients, Bloomberg reported. Executives pleaded in federal court in Philadelphia to one count of shipping misbranded Norian XR across state lines. US Attorney Michael L. Levy said executives will face as long as one year in prison and a $100,000 fine.
Norian is a subsidiary of Synthes, with global headquarters in Switzerland.
On June 16, 2009, US Attorney Michael L. Levy and Acting Assistant Attorney General Michael F. Hertz announced the return of an indictment against Norian Corporation, 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 US Food and Drug Administration (FDA).