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Medical executives face criminal charges for “misbranded” devices

BMJ 2016; 353 doi: http://dx.doi.org/10.1136/bmj.i3270 (Published 10 June 2016) Cite this as: BMJ 2016;353:i3270
  1. Jeanne Lenzer
  1. New York

Two US medical device executives are facing criminal charges for off-label promotion of a device to treat nasal sinus problems.

William Facteau, former chief executive officer, and Patrick Fabian, vice president for sales, of the ear, nose, and throat medical device company Acclarent, have been charged with “distributing adulterated and misbranded medical devices” and securities fraud related to their promotion of the Status medical device to open up nasal sinuses.1 Acclarent was sold to Johnson & Johnson for $785m (£542m; €690m) in 2010.

The Food and Drug Administration had cleared the device under its “510(k)” scheme, which allows devices to be marketed on the basis of the existence of a “substantially equivalent” product (known as a predicate device) already on the market. The predicate device cited by Acclarent was intended to keep sinuses open mechanically. However, the Status device was manufactured in such a way that it could be …

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