Federal District Court Judge Legrome D. Davis sentenced the fourth of four ex-Synthes executives to prison on Tuesday, but also filed a memo that explained the first sentence handed out.
Richard Bohner, who was vice president of operations, got eight months, a $100,000 fine and four months of supervised release for his role in the scheme to illegally promote and test bone cements made by the company. They were used by doctors in back surgeries, three of which ended with patients dying on the operating table.
Synthes never bothered to seek FDA approval for the clinical trials.
In recent years, device and pharmaceuticals companies have paid billions of dollars to settle criminal charges, especially for promoting products not approved for specific uses by the Food and Drug Administration. But executives have rarely gone to prison.
All four ex-Synthes executives pleaded guilty to one misdemeanor count but had hoped for probation. Michael Huggins, 54, of West Chester, a former president of Synthes North America, and Thomas Higgins, 55, of Berwyn, former leader of Synthes' spine division, were sentenced to nine months. John Walsh, 48, of Coatesville, who was in charge of regulatory affairs and got five months in prison. The other three also were ordered to a $100,000 fine.
Huggins, Higgins, and Walsh, sentenced Nov. 21, have said they would appeal.
Before sentencing Bohner on Tuesday, Davis filed a memorandum regarding Huggins' objections to his sentence. As Davis said Tuesday in the Bohner hearing, he wrote that this case goes beyond the idea of the unknowing corporate officer, which is part of the Park Doctrine. That's why the sentences are the longest for misdemeanor violations of the Food, Drug and Cosmetic Act.
Davis' memo said, in part:
"All of the conduct at issue in this matter was carefully planned, studiously assessed, and meticulously implemented by highly-intelligent professionals over a period of years. Huggins personally participated in most of the decisions, and was also the organization's North American leader. All that occurred either happened at his direction, with his full knowledge, or under his command and control. He committed much of the illegal conduct himself. The scope of this behavior and the magnitude of the wrong perpetrated on unsuspecting users of the untested, and unapproved, product was extreme. No similar set of facts can be located in the universe of Park doctrine cases.