Synthes Executive Joins Former Colleagues in Prison

It’s finally over. The last of four ex-Synthes Inc. executives is joining his former colleagues in prison for helping the company illegally promote and test an unapproved bone cement that killed three patients.

Richard Bohner, 57, hugged his wife before being led off in handcuffs to begin the eight-month prison term imposed on him by U.S. District Court Judge Legrome D. Davis in Philadelphia, Pa. Davis sentenced Bohner’s cohorts as well, sending former Synthes North America President Michael Huggins, 53, and spinal division president Thomas Higgins, 54, to jail for nine months. John Walsh, 48, the man in charge of regulatory affairs for the Swiss firm, received a five-month prison term. All four men also must pay a $100,000 fine.

Though a federal grand jury indicted the four on 52 felony counts, 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. Over the last few years, device and pharmaceutical companies have paid billions of dollars to settle criminal charges involving the illicit promotion of unapproved products, but executives have rarely gone to prison.

The Synthes case proved to be an exception, though. Not only did Bohner and his associates actively participate in illegal conduct for profit, they showed a blatant “disregard for the safety of others…and for the sanctity of human life,” according to Davis. Plus, the defendants failed to willingly end their bad behavior or report the patient deaths, and they lied to U.S. Food and Drug Administration (FDA) investigators during an on-site audit, prosecutors charged.

“This is not a Park Doctrine case in the traditional sense,” Davis said during the sentencing.

Certainly not.

Bohner, Higgins, Huggins and Walsh were part of a “fundamentally wrong” attempt to beat competitors by using a bone cement product in clinical trials without first seeking proper FDA approval for the product. The cement—SRS with barium sulfate—had not been okayed for use in the spine, but was nevertheless injected into the backbones of 200 elderly patients to repair their fractured vertebrae. Unapproved use of the cement continued despite two patient deaths in 2003; Synthes stopped the clinical trials only after a third patient died on the operating table after suffering a precipitous drop in blood pressure in 2004.

The SRS cement was made by Norian, a wholly-owned subsidiary of Synthes. Executives had hoped the SRS cement would significantly boost the company’s profits.

Instead, the cement became the downfall of Bohner and his former co-workers. Synthes paid $24.3 million to settle the criminal charges associated with the case, though it has since made up for the hefty disbursement though the court-ordered sale of Norian to Exton, Pa.-based Kensey Nash Corp. Earlier this year, Johnson & Johnson announced it was buying Synthes for $21.3 billion.

Higgins, Huggins and Walsh, sentenced Nov. 21, have vowed to appeal their respective prison terms. Bohner’s attorney would not comment on his punishment.

“The government is pleased with the sentence,” said Assistant U.S. Attorney Mary Crawley, the lead prosecutor on the case. “The court recognized the severity of the harm done.”