Several medical device manufacturer executives were given long terms for rogue clinical trials.
Four executives in total were sentenced – they each had pleaded guilty to one misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce.
Bohner is the last of four executives to be sentenced in the case….On November 21, 2011, Bohner’s former colleagues Thomas Higgins and Michael Huggins received sentences of nine months in prison while former executive John Walsh received a sentence of five months. The defendants, including Bohner, approved rogue clinical trials using the bone void fillers Norian SRS and Norian XR to treat vertebral compression fractures of the spine (“VCFs”) in elderly patients, without the permission of the FDA. Despite known and serious safety concerns that the products could cause fatal blood clots, and despite a warning on the label of XR that the product was not intended for treatment of VCFs, Synthes did not stop the illegal testing until after a third patient had died on the operating table during the space of one year. During a follow-up FDA inspection in May and June 2004, three of the executives – including Bohner – also lied to the FDA investigator.
The district judge apparently told one defendant: “you failed.”