Ex-Synthes Executive Bohner Sentenced To 8 Months In Prison In Bone-Cement Case
14 December 2011 - 7:38AM
Dow Jones News
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;
peter.loftus@dowjones.com
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