A former Synthes Inc. executive was sentenced to eight months in jail for his role in an unapproved trial of a bone-cement compound that led to the deaths of three patients, authorities said.
Richard Bohner, 57, of Malvern, Pennsylvania, was the last of four officials to be sentenced. They pleaded guilty to a single misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce, according to a statement yesterday from the U.S. Attorney’s office in Philadelphia.
The defendants “approved rogue clinical trials” using the bone-void fillers “to treat vertebral compression fractures of the spine in elderly patients,” without the permission of the U.S. Food and Drug Administration, according to the statement. U.S. District Judge Legrome Davis passed sentence yesterday.
Last month, Davis sentenced Michael Huggins and Thomas Higgins, who got nine months in jail; and John Walsh, who got five months.
The cement, approved for elsewhere in the body, was used in the spines of 200 patients with fractured vertebrae. Three patients died from a rapid drop in blood pressure during spinal surgeries, prosecutors said.
Synthes, based in West Chester, Pennsylvania, agreed to plead guilty, sell the Norian unit and pay a $23.5 million fine to settle the case.
Johnson & Johnson agreed to buy Synthes in April for $21.3 billion to become the leader in the $5.5 billion market for devices to treat trauma victims.
Huggins reported directly to Synthes’ chief executive officer. Higgins served as president of the company’s spinal division. Walsh, former director of regulatory and clinical affairs, was hired by Bohner, who served as vice president of operations, according to court documents.
The case is U.S. v. Norian Corp., 09-00403, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).