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.
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