4 Former Synthes Executives Sentenced to Prison Time for Unapproved Bone Cement study
- Michael Huggins (ex-COO @ Synthes) 9 months jail time currently under appeal
- Thomas Higgins (ex-Sr VP @ Synthes) 9 months jail time
- Richard Bohner (ex-VP @ Synthes) 8 months jail time
- John Walsh (ex-Director Clin/Reg @ Synthes) 5 months jail time
Prison delayed for former Synthes exec (Philly.com)
Three former Synthes officials sentenced to prison (Philly.com)
Ex-exec gets 9 months for fatal bone cement trial (Associated Press)
PHILADELPHIA (Dow Jones)–A federal judge sentenced a former Synthes Inc. (SYST.VX) executive to eight months in prison for his role in the medical-device company’s illegal testing and promotion of a bone cement product.
Richard E. Bohner, the former vice president of operations at Synthes, was the last of four ex-Synthes officer to be sentenced to prison in connection with the case. The other three former executives were sentenced in November to prison terms ranging from five to nine months.
“You failed,” U.S. District Judge Legrome Davis told Bohner at a hearing in federal court in Philadelphia Tuesday. “You and the other defendants knew this course of conduct should never have occurred.”
Davis ordered Bohner to start his prison term immediately, and a court official led Bohner out of the courtroom in handcuffs.
The prison sentences are victories for the U.S. Justice Department as it steps up efforts to hold individual executives criminally responsible for corporate violations of food and drug laws.
Bohner had pleaded guilty in 2009 to a misdemeanor charge of shipping adulterated and misbranded bone cement into interstate commerce, and agreed to pay the maximum fine of $100,000. His plea was based on an admission that he failed to prevent or stop illegal tests on humans of the bone cement, Norian XR, according to court documents.
Federal prosecutors asked Davis to sentence Bohner to up to the maximum of 12 months in prison, above sentencing guidelines of up to six months. Prosecutors argued that Bohner, who was in charge of Synthes’ regulatory compliance, not only failed to exercise his oversight responsibilities, but he also was aware of the conduct and a participant.
“He had a duty to speak truth to power, which he did not,” said Assistant U.S. Attorney Mary Crawley.
Bohner’s lawyer, however, requested a fine-only or probationary sentence, saying Bohner made good faith efforts to ensure Synthes’ compliance with laws and regulations, and otherwise led a law-abiding life.
“He tried to do the right thing,” said defense attorney Brent Gurney. “He didn’t always do the right thing.” Davis agreed Bohner made some attempts to speak out against the illegal conduct, but should have done far more.
Synthes and its Norian unit agreed last year to plead guilty to charges that between 2002 and 2004 they conspired to conduct unauthorized clinical trials of the Norian bone cement in surgeries to treat vertebral compression fractures of the spine, a type of fracture that often occurs in the elderly.
The prescribing label for the Norian bone cement, however, specifically warned against using it for vertebral compression fractures, due to concerns it could cause blood clots. The cement was approved to fill bony voids or defects that weren’t essential to bone stability.
Three patients died on the operating table after spine surgeons used the Synthes product in 2003 and 2004. The U.S. Department of Justice hasn’t proved that the cement caused the deaths, but the agency has said the deaths should have raised red flags at Synthes about the product’s safety risks.
To settle the corporate charges, Synthes and Norian agreed to pay $23.2 million in fines, and Synthes sold Norian to Kensey Nash Corp. (KNSY). Synthes, which is headquartered in Switzerland and has major operations in the Philadelphia suburbs, has agreed to be acquired by Johnson & Johnson (JNJ) for about $21 billion in a deal expected to close next year.
White-collar criminal defense lawyers say the Synthes prison terms are among the stiffest penalties to date in cases brought under the so-called “responsible corporate officer doctrine.”
The doctrine holds executives in certain positions of authority criminally liable for alleged violations of food and drug laws, even if they didn’t have direct knowledge of the underlying conduct.
In the Synthes cases, however, Davis said the former executives were aware of and participated in the underlying conduct.
“On the wrongful conduct scale, it’s 11 on a scale of one to 10. It’s over the top,” Davis said Tuesday.
-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581; firstname.lastname@example.org