Former Synthes Executives Jailed over Deaths

Three former executives of Synthes North America are spending the holidays behind bars this year for their role in the unapproved testing of bone cement that killed three patients.

Before sending the group to federal prison late last month, U.S. District Court Judge Legrome D. Davis—sitting in Philadelphia, Pa.—scolded the three men for showing a blatant “disregard for the safety of others…and for the sanctity of human life.” He also reprimanded them for failing to willingly end their bad behavior.

“I can’t understand how there wasn’t a stop sign,” Legrome told the trio. “One adverse event should have been enough to let you know that this course was not right.”

Ultimately, it took three adverse events—patient deaths—for the course to be corrected. The patients died from a precipitous drop in blood pressure after surgeons injected bone cements SRS with barium sulfate, or XR into their vertebrae. Made by Norian, a wholly-owned subsidiary of Synthes, executives were banking on the cement to fill gaps and help heal fractures in the brittle vertebrae of the elderly, a population that is expected to drive future growth in age-related products and procedures. Synthes bigwigs had hoped the SRS and XR bone cements would significantly boost the company’s profits.

Instead, those cements became the downfall of former Synthes North America President Michael Huggins, 53, spinal division president Thomas Higgins, 54, John Walsh and former senior vice president Richard Bohner, 57 (his sentencing was delayed after his attorney collapsed in court). Legrome said the four men bypassed the customary regulatory approval process to gain a competitive advantage for the cements, charging the defendants “plotted to train surgeons in off-label use and then have doctors publish their findings.” Synthes did not have approval from the U.S. Food and Drug Administration (FDA) to use the cements to repair vertebral compression fractures and did not seek approval to use the products in a human trial.

A federal grand jury indicted Bohner, Higgins, Huggins and Walsh in June 2009 on 52 felony counts, but each man pleaded guilty to a single misdemeanor charge under the 1975 Park Doctrine, which holds corporate leaders accountable for wrongdoing that occurs under their tenure. Legrome ruled that the group planned and executed the scheme, though federal prosecutors claim the executives also failed to report the patient deaths and lied to FDA investigators during an on-site audit.

Legrome denied prosecutors the maximum one-year sentence they had sought, giving the men credit for their pleas. The judge sentenced both Higgins and Huggins to nine-month prison terms, three months of probation and $100,000 fines. Walsh received a five-month jail sentence.

Assistant U.S. Attorney Mary Crawley praised the judge for doling out prison terms, telling the Associated Press the punishment “sends the right message, that lying to the FDA and disregarding patient safety has consequences.” The defendants denied any intent to violate FDA protocols, and Higgins contended that he tried repeatedly to prevent off-label use of the cements.

“I didn’t think at the time that we were doing anything illegal,” he wrote in a letter read at the sentencing.

Both Synthes and Norian Corp. pleaded guilty to corporate healthcare fraud charges and agreed to pay $23 million in fines. Synthes also sold the subsidiary as part of the plea deal. Eight months ago, Johnson & Johnson purchased the Switzerland-based manufacturer of plates, rods, screws and power tools for bone repair for $21.3 billion.