Three Synthes Executives Sentenced to Prison Time
[Philadelphia Inquirer (PA)]
Published Date: November 22, 2011 04:17:00 AM EST
Author: By David Sell, The Philadelphia Inquirer
Nov. 22--Three former executives of medical-device manufacturer Synthes Inc. were sentenced to prison Monday. A fourth might have been if his attorney hadn't collapsed while standing at a lectern moments after saying that Synthes' unindicted board chairman was the ultimate authority and responsible for the illegal, sometimes fatal bone-cement trial at the crux of the proceedings.
Michael Huggins, 54, of West Chester, former president of Synthes USA, was sentenced to nine months in prison and taken into custody immediately. Thomas Higgins, 55, of Berwyn, former leader of Synthes' spine division, got the same sentence. John Walsh, 48, of Coatesville, who was in charge of regulatory affairs, got five months.
U.S. District Judge Legrome D. Davis gave Higgins two weeks to report to prison, so he can arrange for extra medical care for his wife. Davis gave Walsh until next Monday to report because Tuesday is his young daughter's birthday.
The three will pay $100,000 each in fines and be on supervised release after prison. All pleaded guilty to a single misdemeanor count under the responsible-corporate-officer doctrine.
Richard Bohner, 56, of Malvern, former vice president for operations, was the third of four on Davis' docket Monday and might have gotten a sentence similar to that received by Huggins and Higgins.
But as one of his attorneys, Brent Gurney, was making the case for why Bohner should get only probation, Gurney collapsed and hit his head on a nearby table. He was given medical attention, including a bandage, because he was bleeding from the back of his head. Within a few minutes, Gurney was moving his hands, and he was conscious as paramedics wheeled him from the sixth-floor courtroom at the federal courthouse and off to Thomas Jefferson University Hospital.
Davis continued Bohner's case, and his sentencing will be rescheduled.
Synthes is a Swiss-based company with facilities and U.S. headquarters in West Chester. It is being acquired by health-care giant Johnson & Johnson for $21.3 billion.
Medical-device and pharmaceutical companies have paid billions of dollars to settle criminal charges over the years, but rarely do their executives go to jail. This time was different because prosecutors showed, with the help of thousands of pages of internal Synthes documents, that executives were actively involved in the illegal promotion and clinical testing of its Norian bone cements used by doctors in back surgeries, three of which ended with patients dying on the operating table.
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," the judge told Huggins in a packed courtroom for the first sentencing hearing.
Huggins did not speak at the hearing, and one of his attorneys, Greg Poe, declined comment after the sentence was delivered.
The same was true for Higgins and one of his attorneys, Adam Hoffinger.
One of Walsh's attorneys, William Lawlor, read a statement from Walsh during the hearing and suggested there might be an appeal on First Amendment grounds. Both declined comment afterward.
"The First Amendment is not what this is about," Davis said.
A former Synthes doctor, upon learning of the unauthorized bone-cement trial, called it human experimentation because of the relatively ad-hoc process and because patients and some surgeons were not given the information required to make an informed choice.
"The government is pleased with the sentences," said lead prosecutor Mary Crawley, of the U.S. Attorney's Office in Philadelphia. "We believe it sends the right message to medical-device and drug companies that lying to the FDA and disregarding patient safety has consequences."
Hansjorg Wyss, the Synthes board chairman who also was chief executive officer when the illegal bone-cement trial occurred, was not in the courtroom, but still he was part of Monday's events.
Gurney, Bohner's attorney, said Wyss was the undisputed leader of the company. "He made some of the very critical decisions that put the trials on the ultimate pathway," Gurney said. "The culture of an organization is set at the top."
Wyss could not be reached for comment.
Because he was not a defendant, Davis did not spend a lot of time discussing Wyss. But the judge turned Gurney's comments back on Bohner after the attorney mentioned several things Bohner should not have been held responsible for, and he suggested a bit of bravery was in order to help save patients' lives.
"Why did he always miss what the right thing was?" Davis asked, adding that all of it amounted to "shameful behavior."
Contact staff writer David Sell at 215-854-4506 or dsell@ phillynews.com or Twitter @ phillypharma. Read his blog at www.philly.com/phillypharma.
(c)2011 The Philadelphia Inquirer
Posted: November 2011