According to Bloomberg News, two executives from Synthes Inc., a medical device maker, pleaded guilt for their role in the company's illegal trials of bone-mending cement that led to the death of three patients. The 52-count indictment accuses executives at Synthes Inc, which is based in West Chester, Pa., of bypassing FDA approval of the trials while knowing that their products, Norian XR and Norain SRS, posed significant risks.
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. Each faces as much as one year in prison and a $100,000 fine according to United States attorney Michael Levy. Mr. Huggins' lawyers, Gregory Poe and Catherine Recker said in an e-mailed statement that "Mr. Huggins has always made clear that he did not do anything knowingly or intentionally wrong."