Three former executives for the medical device maker Synthes Inc. are heading to prison, after being sentenced for their part in the company’s illegal promotion of its Norian bone cement. According to The Wall Street Journal, two ex-Synthes executives were given a sentence of 9 months in prison, while a third is facing 3 months in prison.
The product at the center of the criminal case, 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 earlier, the FDA-approved label for Norian XR warned against such use. Studies have shown that the use of Norian XR in the spine can cause blood 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.
According to The Wall Street Journal, 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 to treat vertebral compression fractures of the spine. 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.
Yesterday in Philadelphia, Pennsylvania, U.S. District Court Judge Legrome 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, according to the Journal. John J. Walsh, former director of regulatory and clinical affairs in the Synthes spine unit, was sentenced to five months in prison.
According to a report from the Philadelphia Inquirer, 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.
Judge Davis put off sentencing Michael D. Huggins, who was chief operating officer of Synthes, after his attorney collapsed in the courtroom.
“There’s a real failure in this particular corporate culture … as to the recognition of responsibility,” Judge Davis said during Mr. Walsh’s hearing.
The U.S. Justice Department had asked the judge to sentence the former executives to prison for up to a year, partly to serve as a deterrent to other health-care industry executives. But the sentences were still seen as a victory for the government, which has recently stepped up efforts to hold individual executives criminally responsible for corporate violations of food and drug laws, the Journal said.
“We believe it sends the right message to the manufacturers of medical devices and drugs, that lying to the FDA and disregarding patient safety has consequences,” said Mary Crawley, an assistant U.S. Attorney who led the prosecution.