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Orthopedic device sales manager pleads guilty to felony misbranding

This article was originally published in The Gray Sheet

Executive Summary

Justin Demming, a former Stryker sales territory manager based in Ohio, pleads guilty in Boston federal court to misbranding a medical device by providing mixing instructions for an orthopedic putty for use with a device in a manner not authorized by FDA. "These mixing instruction documents constituted labeling of the two products, and the labeling was false or misleading" because the two devices were not approved for combined use, according to documents filed with the court Feb. 10. The court noted that Demming "took steps to try to make sure that his instructions were kept 'confidential' by certain recipients of the mixing instructions." In November, another Stryker sales rep, Darnell Martin of Chicago, pled guilty to similar charges. Both could face multi-year prison terms under their plea agreements. A spokesman for Stryker says that the firm is not commenting on the legal matter, other than to say it is responding to the Department of Justice
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