In February 2015, the United States filed a pharmaceutical fraud complaint to permanently enjoin Atrium Medical Corporation, alleging that the company and several co-defendants had introduced various adulterated and misbranded cardiovascular-related devices to the market. After negotiations, Atrium entered into a consent decree for permanent injunction; DOJ and the FDA took the step of barring the defendants from continuing to manufacture their devices until the facilities came into full compliance with the FDCA and “corrected past violations.”

Qui tam relators play an important role in encouraging such enforcement activity and oftentimes are the initial and continuing force assisting FDA scrutiny of wayward medical device-makers.

More information for whistleblowers is located at the Nolan Auerbach & White website.