Inspections, Compliance, Enforcement, and Criminal Investigations

December 13, 2011: Final Former Synthes Executive Sentenced in Unlawful Clinical Trials Case

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Food and Drug Administration
Office of Criminal Investigations

U.S. Department of Justice Press Release

 

For Immediate Release
December 13, 2011

United States Attorney
Eastern District of Pennsylvania
Contact: Patty Hartman
Media Contact
(215) 861-8525

 

PHILADELPHIA - Richard Bohner, 56, of Malvern, PA, was sentenced today to 8 months in prison for one misdeamor count of shipping adulterated and misbranded medical devices in interstate commerce. Bohner is the last of four executives to be sentenced in the case. His former colleagues, Thomas Higgins and Michael Huggins, were each sentenced to nine months in prison; John Walsh was sentenced to five months in prison. The defendants approved clinical trials using the bone void fillers Norian XR and Norian SRS to treat vertebral compression fractures of the spine ("VCFs") in elderly patients. Despite known and serious safety concerns and a warning on the label that the products were not intended for that use, Synthes did not stop the illegal testing until after a third patient had died on the operating table during one of these surgeries. Three of the executives also lied to the FDA during an investigation. The sentences imposed by the Honorable Legrome D. Davis are the the longest sentenced for misdemeanor violations of the Food, Drug and Cosmetic Act under a strict liability theory.

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