Articles Tagged with Medical Devices

On November 17, 2008, two whistleblowers filed a qui tam action against Medtronic, a medical device manufacturer, alleging off-label promotion of Cardioplate, a heart device. The U.S. District Court in Houston recently granted Medtronic a motion to dismiss the case. The device is FDA approved for ablating (removing) tissue to control bleeding during general surgery and to coagulate cardiac tissue during general surgery. According to the dismissed complaint, Medtronic promoted Cardioplate for the treatment of atrial fibrillation (fast and irregular heartbeat), a use not approved by the FDA as safe and effective. Continue reading ›