Medical executives face criminal charges for “misbranded” devices

BMJ 2016;353:i3270
Author: Jeanne Lenzer
“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.”
Find extract here.