Former Synthes Inc. North America president Michael Huggins was sentenced to 9 months in federal prison for his role in unauthorized Norian bone cement trials in which three patients died during surgery.
The decision was handed down today by Judge Legrome Davis of the U.S. District Court for Eastern Pennsylvania. Three other former Synthes executives still await sentencing.
Huggins’ looming incarceration marks the first sentence 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.
Former senior VP Thomas Higgins, 54; VP Richard Bohner, 57; and director of regulatory and clinical affairs John Walsh, 48, all admitted to misdemeanor counts connected with the off-label use of the bone cement in vertebral compression fracture surgeries.
The quartet was indicted in June. In addition to the personal charges; Norian Corp. faced a total of 52 felony counts, including conspiracy to obstruct the Food & Drug Administration 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 its 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, according to the Wall Street Journal.
Although three patients died during the procedures, according to the 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.
But the company and the accused executives were allegedly aware of the risks and knew that at least two patients had died, the indictment alleges.
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 Norian. 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.