Three medical device executives from suburban Philadelphia are headed to prison. One other Synthes company executive is also scheduled for sentencing Monday.
Michael Huggins, the former North America president of the Chester County-based Synthes, and three others were at the helm of the company when it conducted unlawful clinical trials of a bone cement. Three patients died soon after doctors used the glue during spinal surgery.
Federal Judge Lagrome Davis sentenced Huggins of West Chester and former Senior Vice President Thomas Higgins of Berwyn to nine months in jail and a $100,000 fine each.
During Huggins’ hearing, the judge said the “wrongfulness” of the conduct was “11 on a scale of 10.”
The former executives pleaded guilty to a misdemeanor under a little-used law sometimes called the “responsible corporate officer doctrine.”
Andrew Fichter, a health law expert at the Widener School of Law, said he was not surprised the men got jail time.
“Pharmaceutical companies have been hit with larger and larger dollar settlements for violations of (U.S. Food and Drug Administration) rules and regulations,” he said. You may have heard about a recent settlement with GlaxoSmithKline and one before,” Fichter said. “I think that the FDA has decided that it needs to raise the stakes.”
Fichter says authorities are stepping up enforcement to hold executives criminally and personally responsible when a firm violates U.S. food and drug laws.
The Synthes bone cement was not approved for spine surgery. Davis said there were enough signs along the way to “stop a freight train,” yet Huggins “assessed the risk” and continued on in disregard for life.
Davis said Huggins’ sentence should serve as a message to other executives in the health care industry.
Richard Bohner of Malvern and John Walsh of Coatesville also were scheduled to appear before Davis for sentencing Monday.