Another plea agreement in device misbranding
This article was originally published in The Gray Sheet
Executive Summary
Former Stryker sales rep Shane Doyle pleads guilty to medical device misbranding in Boston federal court April 14 in a case that mirrors at least two others against former sales reps and managers for Stryker (1"The Gray Sheet" Feb. 16, 2009, In Brief). Doyle allegedly promoted an unapproved use of Stryker orthopedic putty by distributing mixing instructions, including those stating "this could be printed out and put in the fridge with the OP-1 to make sure there are no questions on how to mix." In a plea agreement, Doyle agreed to "cooperate fully with law enforcement agents and government attorneys.
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Orthopedic device sales manager pleads guilty to felony misbranding
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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Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
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Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.