Did patients give informed consent when getting HVAD devices?

It’s a tough choice when patients are already very sick. Medical devices sometimes offer the promise of extended life, but they can themselves be risky – or outright defective or unreasonably dangerous. Patients should always be given full information about the potential risks and benefits of any medical treatment or device, but that doesn’t always happen. Even when it does, sometimes a manufacturer doesn’t always tell the health care professional or the public all they should about a device.

Recently, the non-profit investigative newsroom ProPublica published an exposé about the HeartWare Ventricular Assist Device, or HVAD, an implantable heart support device for people with serious heart problems that may require a heart transplant.

There were manufacturing and operational problems from the beginning with the HVAD, but most patients were never told. Thousands of people received the device, which has the potential to shut down unexpectedly or refuse to restart if disconnected from its electricity sources.

More troubling still, the U.S. Food and Drug Administration (FDA) has known about serious problems with the HVAD since at least 2011. Nevertheless, it approved the device for sale in 2012. And, when the dangerous problems continued, the FDA relied exclusively on voluntary changes by the company (HeartWare International) to address the issues. The FDA never did more than issue warning letters. In fact, it allowed the company to expand use of the device.

This was all true despite there being a safer, more effective competitor device.

Patients simply can’t count on the FDA

When people are confronted with the need for a medical device, they rely on the fact that the FDA reviews and approves these devices. They rely on a system that is supposed to notify them about known issues with their devices. They rely on their doctors to know about those issues. And they rely upon the manufacturer to keep the FDA, doctors, and the public fully informed.

Unfortunately, this system fails far too often. According to the report, there were problems with the HVAD from the start and they just kept cropping up. In 2014, The FDA issued a warning letter to the manufacturer calling the device “adulterated,” meaning it failed to meet federal manufacturing standards. It gave the company 15 days to correct the issue or face regulatory action.

The company failed to meet that deadline, but it never faced any regulatory action – just more calls for voluntary compliance.

Inspectors found continued problems with the HVAD’s manufacturing facility in 2015, 2016, 2017 and 2018. In 2018, they found seven separate violations, including three that had been ongoing since 2014 with no resolution.

Meanwhile, patients were dying. When ProPublica contacted the FDA about its apparent inaction, it said that it had given HeartWare additional time to address the problems because it was a relatively new company and the HVAD was so complicated. It withheld more punitive actions because the device was only prescribed to the sickest of the sick, who had few alternatives.

But ProPublica points out there was a relatively good alternative in a competing device, the HeartMate, made by Abbott Laboratories.

Medtronic bought HeartWare International in 2016, but the problems continued. Ultimately, Medtronic stopped selling the HVAD in June of this year. It conceded that the competitor HeartMate was safer and that the HVAD was associated with higher rates of neurological injury and death.

Medtronic continues to support the approximately 4,000 patients who still have the HVAD implanted. This is crucial, because removing the device is so risky that both Medtronic and the FDA advise patients and doctors not to attempt it. The device is only meant to be removed when a patient receives a heart transplant.

Although the device is no longer on the market, it is likely that many patients remain unaware of the long-term, unresolved manufacturing defects associated with the device. If you or a loved one has had an HVAD implanted, you may have legal rights to protect. Contact an attorney who handles product liability cases.

Skip to content