A Congressional Oversight Committee is investigating the Food and Drug Administration’s response to the faulty HeartWare Ventricular Assist Device (HVAD). The device is used to treat patients with heart failure but has been linked to more than 3,000 reported deaths. The FDA has monitored HeartWare’s device since 2014 after receiving reports that the device stopped functioning resulting in cardiac arrest and cardiac ischemia. After the FDA found serious manufacturing and functional issues with the HVAD, labeling it “adulterated,” the FDA sent a letter to the manufacturer requesting that the HeartWare notify patients of the risks associated with the device, but HeartWare failed to send out any notice for years.
Through June 2021, the FDA allowed HeartWare to continue marketing and selling the device, which was implanted in thousands of patients across the country. When HeartWare finally removed the device from market in June 2021, it still did not warn patients about the serious problems with the device. Around 2,000 patients have subsequently demanded that their HVAD be removed and replaced with a similar device from competitors. HeartWare claimed it would provide financial and technical support to remove the device from those patients, but very few have received such support to date.
When you or someone you love is impacted by a medical device, a personal injury lawyer should be consulted regarding the potential liability of the manufacturer and retailer. SUGARMAN has a team of dedicated personal injury attorneys who represent those who have been injured. If you have been hurt or impacted by a medical device and wish to speak to one of our attorneys regarding liability, please fill out a Contact Form, call us at (617) 542-1000 or e-mail info@sugarman.com.