Tuesday, July 7, 2015

Synthes exec pleads guilty in bone-cement case

0 comments
Travel Deals

A fourth Synthes Inc. executive yesterday pleaded guilty in Philadelphia to charges stemming from illegal clinical trials of a bone cement. Three people died in connection with the experimental surgeries.

Richard E. Bohner, the vice president of operations, admitted to shipping misbranded Norian XR, a bone cement, across state lines, a misdemeanor.

He faces up to a year in prison plus a $100,000 fine, according to federal court documents.

Neither Bohner nor his lawyers were available for comment late yesterday.

Synthes, of West Chester, is the world's largest maker of bone-related medical devices. Its Norian Corp. unit and the four officers were indicted in June over claims they conspired to conduct unauthorized clinical trials of Norian cements from May 2002 to late 2004.

Three patients died from a rapid drop in blood pressure during surgeries, but it was not clear whether the bone cement played a role in the deaths, prosecutors said. Synthes entered a not-guilty plea July 30. The company has defended its marketing practices and said it intends to fight the charges.

Norian, the Synthes unit that made the bone cement, faces 52 felony counts, including seven counts of making false statements in connection with an FDA inspection. The Food and Drug Administration had told Synthes executives to do clinical trials before using Norian XR in a type of surgery known as vertebroplasty, but they did not. A drug is misbranded if it is marketed without adequate information about its use for a specific purpose.

Three other Synthes executives, Michael Huggins, John Walsh and Thomas Higgins, pleaded guilty last month.

 


Contact staff writer Miriam Hill

at 215-854-5520 or hillmb@phillynews.com.

Inquirer Staff Writer
0 comments
We encourage respectful comments but reserve the right to delete anything that doesn't contribute to an engaging dialogue.
Help us moderate this thread by flagging comments that violate our guidelines.

Comment policy:

Philly.com comments are intended to be civil, friendly conversations. Please treat other participants with respect and in a way that you would want to be treated. You are responsible for what you say. And please, stay on topic. If you see an objectionable post, please report it to us using the "Report Abuse" option.

Please note that comments are monitored by Philly.com staff. We reserve the right at all times to remove any information or materials that are unlawful, threatening, abusive, libelous, defamatory, obscene, vulgar, pornographic, profane, indecent or otherwise objectionable. Personal attacks, especially on other participants, are not permitted. We reserve the right to permanently block any user who violates these terms and conditions.

Additionally comments that are long, have multiple paragraph breaks, include code, or include hyperlinks may not be posted.

Read 0 comments
 
comments powered by Disqus
Also on Philly.com:
letter icon Newsletter