Competing interests: BB and HMK report that they have been experts (on behalf of the plaintiff) for litigation related to a specific type of IVC filters. HMK was a recipient of a research grant, through Yale, from Medtronic and the US Food and Drug Administration to develop methods for post-marketing surveillance of medical devices; is a recipient of a research agreement with Medtronic and Johnson & Johnson (Janssen), through Yale, to develop methods of clinical trial data sharing; works under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures that are publicly reported; chairs a Cardiac Scientific Advisory Board for UnitedHealth; is a participant/participant representative of the IBM Watson Health Life Sciences Board; is a member of the Advisory Board for Element Science and the Physician Advisory Board for Aetna; and is the founder of Hugo, a personal health information platform.