Three former Synthes Inc. officials were sentenced to prison Monday for unapproved medical trials of a bone-cement drug in spinal surgeries that left three people dead.
Michael Huggins, former Synthes North America president, and Thomas B. Higgins, former spinal division president, got nine-month prison terms, three months probation and $100,000 fines, while ex-Director of Regulatory Affairs John Walsh got a five-month prison term because he worked in the company for a lesser time.
Since the lawyer of former Senior Vice President Richard Bohner collapsed in court, his sentencing was postponed.
The four officials were charged in June 2009 on a total of 52 felony counts.
Three former Synthes executives are among the first corporate officials ever sent to prison after pleading guilty for misbehavior as “responsible corporate officers” under the 1975 Park Doctrine.
While announcing the sentences, U.S. District Judge Legrome D. Davis said the officials bypassed the safety rules and lengthy approval process to gain a competitive advantage.
He said the officials plotted to train select surgeons in its off-label use and then have the doctors publish their findings, the Associated Press reported.
But the officials continued their program even after patients were reported dead in 2003, in Texas and California, after surgery.
After the bone cement compound was injected into patient’s spines they suffered sharp drops in the blood pressure. It was after the third death in 2004 that Synthes halted the training.
A report by The Inquirer describes what exactly happened between 2002 and 2004:
Three patients died on the operating table when their blood pressure dropped precipitously, shortly after the surgeon injected bone cements SRS, with barium sulfate, or XR into their vertebrae. The bone cements were produced by Norian, a wholly owned subsidiary of Synthes. Synthes hoped the bone cements would fill gaps in the vertebrae of millions of older people and fill the company coffers.
The problem was that Synthes did not have approval from the U.S. Food and Drug Administration to use the cement for the specific back procedure (vertebral compression fractures) and never bothered to seek approval for a human trial, in which patients get to choose whether to participate, among other criteria. The company ignored those problems. Employees supplied the bone cement to surgeons, trained them in its use, and often helped in the operating room.