Synthes Ex-President Sentenced For Fatal Testing of Bone Cement On Humans

Former Synthes North America President Michael Huggins was the first of four executives to be sentenced Monday for conducting unauthorized testing on humans.

A federal judge said Monday that the pursuit of profits blinded Huggins to the "the sanctity of human life,” reports AP.

Huggins was hit with a nine-month prison sentence for unapproved medical tests that caused the deaths of three patients.

U.S. District Judge Legrome D. Davis called their actions "egregious" and said the officers showed "disregard for the safety of others ... and for the sanctity of human life."

The judge denied Huggins' bid for probation and ordered him to be imprisoned immediately, reports AP.

The other defendants being sentenced Monday were former senior vice president Thomas B. Higgins, of Berwyn; ex-director of regulatory and clinical affairs John J. Walsh, of Coatesville; and former Synthes Vice President Richard Bohner, of Malvern.

In 2009, each executive pleaded guilty to a single misdemeanor as a "responsible corporate officer." No-one had previously been imprisoned under that statute at the time, reports AP.

However, prosecutors accused them of "human experimentation," and indicated they would soon strive to have the defendants imprisoned.

Norian XR and Norian SRS bone cement had been approved for surgical use in some body parts, but not the weight-bearing spine. Yet, in its eagerness to outdo its rivals, Synthes proceeded to use the cement in about 200 spine patients. The patients who died suffered a severe drop in blood pressure following the injections. None of the surgeons could rule out the bone cement had contributed to the deaths, but it was also not deemed solely responsible for them, reports AP. Despite one patient dying in Plano, Texas, the tests continued, before two others then died in northern California. Davis said that each was frail and had a multitude of health problems. According to prosecutors, the defendants not only tested the bone cement on humans, but failed to report the deaths and lied to FDA investigators, AP reports. According to a letter Huggins’ lawyer read in court Monday, Huggins wrote, "I didn't think at the time that we were doing anything illegal.”
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