Three former Synthes executives received prison sentences for their roles in the unauthorized human trials of an experimental bone cement that left three patients dead.
Former North America president Michael Huggins and former executive VP Thomas Higgins each got 9 months in federal prison followed by probation, as well as $100,000 in fines apiece.
John Walsh, the former director of regulatory and clinical affairs, got 5 months in federal prison for his complicity. His sentence was pushed off by a week to allow him to attend his daughter’s birthday party.
And former VP Richard Bohner is still awaiting sentencing after his lawyer’s collapse stalled the proceedings. While attorney Brent Gurney was making a case for a probation-only decision, he collapsed and hit his head on a nearby table. Gurney was bleeding from the back of the head and was wheeled out of the courtroom by paramedics, according to the Philadelphia Inquirer. Bohner’s sentencing will be rescheduled, according to the newspaper.
The decisions were handed down by Judge Legrome Davis of the U.S. District Court for Eastern Pennsylvania. Huggins was taken into custody immediately, while Higgins was given two weeks to make arrangements for medical care for his wife, according to the Philly paper.
Their looming incarceration marks the first sentences handed down under the 1975 Park Doctrine, whereby executives may be held accountable as "responsible corporate officers" whether they intended to break the law or not.
"You are being punished for the decisions you made and personally participated in," Davis told Huggins as he handed down his decision yesterday.
The quartet of ex-execs was indicted in June. In addition to the personal charges, Synthes subsidiary Norian Corp. faced a total of 52 felony counts, including conspiracy to obstruct the FDA and "to commit crimes against the United States," according to a Justice Dept. release. The company was also slapped with seven counts of making false statements in an FDA investigation and 44 counts of releasing "adulterated and misbranded" shipments of the Norian XR cement "with intent to defraud."
Lawyers for the executives had asked that they be given sentences in fines or probation, on grounds that prison terms would be excessive. Although three patients died during the procedures, according to the indictments, 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.
But prosecutors alleged that the company and the accused executives were aware of the risks and knew that at least two patients had died, according to the indictments.
Last year, West Chester, Pa.-based Synthes pleaded guilty to its part in the affair and agreed to pay fines totaling $23.2 million. The deal also called for Synthes to ditch Norian.
Exton, Pa.-based Kensey Nash Corp. (NSDQ:KNSY) later 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.
