Executives of Synthes North America, a medical devices company, have been sentenced to prison for unapproved tests of bone cement that left three people dead. According to the judge, the Synthes officials wanted to beat their competitors to market without going through the lengthy process of getting FDA approval.
Instead, they conspired to train select surgeons to use the bone cement in unapproved ways and publish their findings. They continued the program even after two patient deaths in 2003, caused by sharp drops in blood pressure caused when the bone cement compound was injected into their spines.
Drug Discovery and Development reports:
“Former President Michael Huggins ... and former Senior Vice President Thomas B. Higgins ... were sentenced to nine months in prison. John J. Walsh ...the former director of regulatory and clinical affairs, worked at the West Chester-based company less time and received a five-month sentence. Former Synthes Vice President Richard Bohner ... had his sentencing postponed after his lawyer became ill in court ... All four executives have lost their careers and agreed to pay fines of $100,000 apiece.”