Former Synthes Execs Get Prison Time For Unauthorized Spine Trial

Article preview from "The Gray Sheet"- November 28, 2011

Federal authorities doled out prison time and fines to former executives of spinal fixation firm Synthes, and sent a broader warning to everyone in the industry about the penalties of corporate non-compliance for individuals.

Former Synthes Execs Get Prison Time For Unauthorized Spine Trial

Article preview from "The Gray Sheet"- November 28, 2011

Federal investigators say the sentencings of several former medical device industry executives last week for violations of the Federal Food, Drug and Cosmetic Act should serve as a clear warning that individuals can be held responsible for the indiscretions of their firms.

Three former executives from spinal fixation device maker Synthes and its former subsidiary Norian Corp. were sentenced to time in prison and a $100,000 fine each Nov. 21 for their role in conducting unauthorized trials of the Norian XR and Norian SRS bone cement products.

Former Synthes CEO Michael Huggins was sentenced to nine months in prison, as was Thomas Higgins, former senior VP of global strategy; John Walsh, former director of clinical and regulatory affairs, received a five-month sentence. A fourth executive, Richard Bohner, former VP of operations, will be sentenced at a later date, the U.S. Attorney for the Eastern District of Pennsylvania said last week.

The four had pleaded guilty in July 2009 to a misdemeanor count for shipping adulterated and misbranded devices in interstate commerce.Synthes and Norian also entered guilty pleas for the crimes and agreed to pay a total of $23.2 million in criminal penalties, and Norian was excluded from participation in federal health care programs. The charges stem from a June 2009 indictment.

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