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Prison For Exec In Fatal Bone Cement Case

A judge imposed an eight-month sentence and a $100,000 fine on Richard Bohner for attempting to bypass FDA approval with deadly results.

PHILADELPHIA (AP) — A fourth former executive of a medical devices company has been sentenced to prison in connection with unapproved testing of bone cement that left three people dead.

U.S. District Judge Legrome D. Davis on Tuesday imposed an eight-month sentence and a $100,000 fine on 56-year-old Richard Bohner of Malvern, a former vice president of Synthes North America. He had pleaded guilty earlier to a misdemeanor count of introducing adulterated and misbranded medical devices into interstate commerce.

Three other company executives were sentenced last month after similar pleas, among the first imprisoned as "responsible corporate officers" under the 1975 Park Doctrine.

Former president Michael Huggins, 54, of West Chester, and former senior vice president Thomas B. Higgins, 54, of Berwyn, were sentenced to nine months in prison. John J. Walsh, 48, of Coatesville, the former director of regulatory and clinical affairs, worked at the West Chester-based company less time and received a five-month sentence. Bohner's sentencing was postponed after his lawyer became ill in court.

Davis said the officials wanted to beat their competitors to market without going through the lengthy process of getting the bone cement product approved by the U.S. Food and Drug Administration. So, they plotted to train select surgeons in its off-label use and then have the doctors publish their findings, the judge said.

The program continued even after a patient died in surgery in Texas in 2003 and another died in California. The patients suffered sharp drops in blood pressure after the bone cement compound was injected into their spines. Synthes only halted the training after a third death in 2004.