Three executives of a medical device company, Synthes Inc., have received prison terms in connection with the business’ promotion of a bone cement for unauthorized uses.

The company’s product was linked to the deaths of three spinal surgery patients in 2003 and 2004, although the Department of Justice never proved that the bone cement caused the fatalities.

As The Philadelphia Inquirer reports, Michael Huggins, 54, who was president of Synthes USA, and Thomas Higgins, 55, former president of the Synthes spine division, were sentenced to nine months in federal prison. John Walsh, 48, former regulatory director for the spine unit, was sentenced to five months. Sentencing for a fourth executive, Richard Bohner, former vice president of operations, was postponed after his lawyer  collapsed in court.

Federal prosecutors argued that the executives were actively involved in the illegal promotion and clinical testing of bone cement made by the company’s Norian unit. The product was used by doctors in back surgeries, including the procedures that left three patients dead on the operating table.

The sentences, The Wall Street Journal reports, were victories for the Justice Department’s push to hold executives criminally responsible for corporate violations of food and drug laws. Federal sentencing guidelines called for prison terms of zero to six months, but the 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 executives.

The four men pleaded guilty in 2009 to a misdemeanor charge of shipping adulterated and misbranded bone cement under what is known as the responsible corporate officer doctrine. They each have agreed to pay the maximum fine of $100,000.

Synthes and its Norian unit agreed last year to plead guilty to charges that between 2002 and 2004 they conspired to conduct unauthorized clinical trials of the Norian bone cement in surgeries for  vertebral compression fractures of the spine. The surgeries were carried out with the cement even though the product carried a warning that it should not be used for such fractures because it could cause blood clots.

The case was heard in Philadelphia, near West Chester., Pa., where Swiss-based Synthes has its U.S. headquarters.


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