Fourth and final indicted Synthes ex-VP Richard Bohner was sentenced to 8 months in prison for his role in illegal human trials of an experimental bone cement that left three patients dead.
The decision follows news last month that former Synthes 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.
Bohner’s sentencing was delayed after his lawyer collapsed during proceedings late last month. 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.
Judge Legrome Davis of the U.S. District Court for Eastern Pennsylvania handed down the final sentence yesterday, calling the former executives’ involvement in the unauthorized human trials "stark and disturbing," according to the Philadelphia Inquirer.
Their sentences mark the first 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.
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."
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.
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