The FDA has very strict standards for medical devices. Manufacturers must put their devices through rigorous testing before they are approved for sale, and then must continually submit to inspections and report issues to the federal agency.
Unfortunately, as strong as the FDA can be when it comes to regulation, it is not always as strong when it comes to enforcement. If it turns out that a medical device design is defective, the agency has limited capability to make the manufacturer fix the problem.
In a recent report, reporters detailed long-running problems with an electronic heart pump known as the HeartWare Ventricular Assist Device, or HVAD. Manufactured by a company called HeartWare, the device helps the heart to pump blood, and is powered by rechargeable batteries which the patient typically wears on a belt. HeartWare got FDA approval to market the device in 2012, and it was implanted in 19,000 patients in the United States and more abroad.
Soon, reports came in about problems with the device. Some patients had blood clots that were exacerbated by the device. Others found the batteries would not recharge when they needed them. By 2014, the FDA had reports of 3,000 deaths that may have been caused by the HVAD. That same year, the FDA found the device did not meet standards and called for HeartWare to resolve the problem.
The FDA followed up in 2016 and 2018, but found the issues had not been resolved. HeartWare was acquired by medical device giant Medtronic in 2016, and Medtronic discontinued the HVAD this year.
There are still at least 2,000 Americans relying on HVADs to keep their hearts functioning properly, and twice that number in the rest of the world. The surgery to remove the device is so dangerous that medical authorities recommend avoiding it unless it becomes an immediate emergency.
This tragic story highlights some of the difficulties of protecting patients from defective medical devices. Sometimes the best way to hold manufacturers accountable for their defective products is through a lawsuit based on the legal theory of product liability.