Prison Possible for Former Synthes Execs

Four former Synthes Inc. executives involved in last year’s unauthorized bone cement trial that resulted in three patients’ deaths could face prison time, according to federal prosecutors.

Michael Huggins, former Synthes North America president; Thomas Higgins, former senior vice president; Richard Bohner, former vice president; and John Walsh, former director of regulatory and clinical affairs—admitted to misdemeanor counts relating to off-label use of the bone cement in vertebral compression fracture surgeries.

Evidence presented at the executives’ trial suggested the bone cement could potentially cause fatal blood clots in the lungs, and therefore was not approved for the procedures.

If prison time is in the cards, the former executives will be sentenced under the 1975 Park Doctrine, meaning they will be held accountable as “responsible corporate officers” regardless of their intention to break the law.

“The question is, what did Mr. Huggins know and when did he know it?” asked Huggins’ lawyer Gregory Poe, who contends that his client was not aware of many of the details of the trial, despite agreeing to shoulder some responsibility of the study.

Synthes, headquartered in West Chester, Pa., pleaded guilty to the charges last year and agreed to pay fines totaling $23.2 million. The company also consented to unload its Norian subsidiary, which was picked up last month by Exton, Pa.-based Kensey Nash Corp. for $22 million in cash.