Another former executive of Synthes has been sentenced to prison over the company’s illegal testing and promotion of its Norian bone cement. According to a report from The Wall Street Journal, Richard E. Bohner, the former vice president of operations at Synthes, was sentenced to eight months by U.S. District Judge Legrome Davis during a hearing in Philadelphia yesterday. He is the fourth – and last – Synthes executive to be sentenced to jail time in the Norian bone cement scandal.
Norian XR Bone Cement was approved by the Food & Drug Administration (FDA) in 2002 for use in the arm, but not the spine. As we reported previously, Synthes and its Norian unit agreed last year to plead guilty to federal charges that between 2002 and 2004 they conspired to conduct unauthorized clinical trials using the bone cement in a type of spinal procedure. Federal prosecutors said three people died on the operating table while undergoing such procedures. Though it wasn’t proven that the Norian bone cement caused the deaths, regulators said they should have raised red flags about the product’s safety risks.
The FDA-approved label for Norian XR warns against use in the spine, and studies have shown that such use can cause clots that could become lodged in the lungs, leading to death. Synthes received a warning letter from the FDA in November 2004 regarding improper marketing of the product for vertebral compression fractures. Norian XR was finally pulled from the market after the warning letter was issued.
In sentencing the 57-year-old Bohner, Judge Davis said that his conduct and that of his colleagues at Synthes was “fundamentally wrong.
“You failed,” Davis said “You and the other defendants knew this course of conduct should never have occurred.”
Bohner was ordered to start servicing his prison term immediately.
According to The Wall Street Journal, federal prosecutors had pushed Judge Davis to impose a 12-month sentence. But the judge agreed with the defense assertion that Boehner made some attempts to speak out against the illegal conduct, but should have done more. Boehner who was in charge of Synthes’ regulatory compliance, not only failed to exercise his oversight responsibilities, but he also was aware of the conduct and a participant, prosecutors said.
Last month, Judge Davis sentenced Michael D. Huggins, who was chief operating officer of Synthes, and Thomas B. Higgins, former president of the Synthes spine division, to nine months in federal prison Monday, John J. Walsh, former director of regulatory and clinical affairs in the Synthes spine unit, was sentenced to five months in prison. They and Bohner will also each pay a $100,000 fine.
According to The Wall Street Journal, the sentences are seen as a victory for the federal government, which has recently stepped up efforts to hold individual executives criminally responsible for corporate violations of food and drug laws. The cases were prosecuted under a principle known as the “responsible corporate officer doctrine, which holds executives in certain positions of authority criminally liable for such violations, even if they didn’t have direct knowledge of the underlying conduct.