Update: Two ex-Synthes executives, Michael Huggins and Thomas Higgins, get 9 months in prison

UPDATE 3 p.m.: At about 2:45 p.m., Brent Gurney, the attorney for Richard Bohner, collapsed while standing at a lectern discussing his client with Judge Davis. Gurney was bleeding from his head, apparently having hit a nearby table as he fell.

Court went into recess, while paramedics were called. Gurney could be seen moving his hands and taking instructions. He was wheeled from the sixth floor court room to an elevator.

Bohner’s case was adjourned without him being sentenced.

Here is the rest of today’s story:

Former Synthes executives Michael Huggins and Thomas Higgins were sentenced Monday to nine months in prison with three months probation and a $100,000 fine for their roles in the medical device company’s illegal promotion and clinical test of bone cements used by doctors in back surgeries, three of which ended with patients dying on the operating table.

Huggins and Higgins were the first of four company executives to be sentenced by Judge Lagrome D. Davis in federal district court in Philadelphia. Richard Bohner was scheduled to be sentenced at 2 p.m. and John Walsh at 5 p.m.

Synthes, a Swiss-based company with facilities and U.S. headquarters in West Chester, makes plates, rods, screws and power tools to fix broken bones.

Davis said Huggins, the highest ranking executive of the four, showed a “knowing disregard” for the safety of patients.

“You are being punished for the decisions you made and personally participated in,” Davis told Huggins and the packed court room at the Federal Courthouse at 6th and Market Streets.

Huggins did not speak at the hearing and his attorney, Greg Poe, declined comment.

Higgins also did not speak at the hearing and his attorney, Adam Hoffinger, also declined comment immediately afterward.

Barring appeals of the sentencing, Monday brought to a close the criminal phase of what one former Synthes doctor called a case of “human experimentation.”

“This is a case where the regulations in place to perform clinical trials and protect human subjects were not just ignored, they were flouted,” prosecutors said in a pre-sentence filing.

Medical device and pharmaceutical company executives rarely go to prison when their companies break the law, so Monday’s decision was unusual.

Huggins, 53, of West Chester, was president of Synthes North America for most of the period from 2002 to 2004 when the illegal trial took place.

Higgins, 54, of Berwyn, was president of Synthes spine division. Bohner, 57, of Malvern, was senior vice president of operations. Walsh, 48, of Coatesville, Director of regulatory and clinical affairs, though he joined Synthes full-time in 2003.

Three patients died on the operating table when their blood pressure dropped precipitously, shortly after surgeons injected bone cements SRS, with barium sulfate, or XR into their vertebrae. The bone cements were produced by Norian, a wholly-owned subsidiary of Synthes. Synthes hoped the bone cements would fill gaps in the vertebrae of millions of older people and fill the company coffers.

The problem was that Synthes did not have approval from the U.S. Food and Drug Administration to use the cement for the specific back procedure (vertebral compression fractures) and never bothered to seek approval for a human trial, in which patients get to choose whether to participate, among other criteria. The company ignored those problems. Employees supplied the bone cement to surgeons, trained them in its use, and often helped in the operating room.

The four pleaded guilty to a single misdemeanor count under the responsible corporate officer doctrine.

That doctrine holds executives responsible if illegal activity happened on their watch and if they did nothing to stop the activity upon learning of it. But prosecutors argued the four went beyond just being on the payroll and were actively involved in the illegal promotion and trial. Davis seems to have agreed, based on his answers to defense objections in a pre-sentencing filing last week.

“Based on the record evidence of relevant conduct, the court finds that the patients were directly and proximately harmed by the conduct of defendants and others at Synthes,” Davis wrote last week, without revealing his decisions on sentences. “Defendants subjected the patients to the risks of SRS and XR without the patients’ full informed consent and without the FDA’s authorization.

“Some of those patients were injured and some died. By conducting unauthorized clinical trials of SRS mixed with barium sulphate and XR on human beings, defendants disregarded the safety of all members of society.”

In court filings, attorneys for all four defendants argued for probation and a $100,000 fine.

Prosecutors from the U.S. Attorney’s Office in Philadelphia argued for the maximum of one year in prison and the $100,000 fine for Huggins, Higgins and Bohner. Only because Walsh was employed by Synthes for a shorter amount of time than the others, prosecutors said, nine months and a $100,000 fine was appropriate.

Sunday’s Inquirer story is here. The web site has links to other material on this case, which fully emerged in 2009.

Chairman of the board and former CEO Hansjorg Wyss was not charged. Prosecutors declined to say why.

Synthes is being bought by Johnson & Johnson for $21.3 billion.

In a proxy statement filed by J&J, the Synthes’ contribution included only a couple paragraphs on the bone cement case. Referring to the $24.3 million paid to settle the criminal charges, the company said in the filing, “The payments did not have a material effect on the financial performance or financial position of the group.”

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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