Federal prosecutors want four former Synthes Inc. executives to spend up to a year in jail after they pleaded guilty to their roles in an un-authorized bone cement trial in which three patients died during surgery.
The four — former Synthes North America president Michael Huggins, 53; former senior vice president Thomas Higgins, 54; vice president Richard Bohner, 57; and director of regulatory and clinical affairs John Walsh, 48 — admitted to misdemeanor counts connected with the off-label use of the bone cement in vertebral compression fracture surgeries. The bone cement was not approved for the procedures, allegedly due to evidence that it might cause potentially fatal blood clots in the lungs.
Although three patients died during the procedures, according to the original indictment, it’s never been established that Norian XR, a calcium phosphate-based bone void filler the FDA cleared in 2002 to treat fractures, caused the deaths.
If the former execs draw prison time, they’ll be the first sentenced under the 1975 Park Doctrine, held accountable as "responsible corporate officers" whether they intended to break the law or not.
Huggins’ lawyer said his client did not know many of the particulars of the study, despite agreeing to shoulder some responsibility, according to the Philadelphia Inquirer.
"The question is, what did Mr. Huggins know and when did he know it?" lawyer Gregory Poe said, according to the newspaper.
Last year, West Chester, Pa.-based Synthes pleaded guilty to the charges and agreed to pay fines totaling $23.2 million. The deal also called for Synthes to ditch its Norian subsidiary. Last month Exton, Pa.-based Kensey Nash Corp. (NSDQ:KNSY) stepped up to the plate and agreed to take a swing at the entire Norian product line for $22 million in cash. As part of a long-term supply agreement, Kensey Nash will manufacture the Norian products, and Synthes will exclusively distribute the products worldwide.