A heart pump implant called the HeartWare Ventricular Assist Device, or HVAD was meant to give patients time to find transplants. It was first introduced into the U.S. market in 2012.
Turns out it has been failing patients at alarming rates for the past decade.
Was no one aware of the dangers?
According to FDA records, the agency learned of problems with the device as early as 2011, including battery issues and issues with short-circuiting. In 2014, the agency finally demanded corrective actions, but took no other action against the company – despite the fact the problems continued.
The implant was placed in approximately 19,000 patients between 2012 and this June when Medtronic removed the device from the market.
The number of deaths from device failure from 2012 to 2021?
Estimated to be 3,000.
The number of serious injuries? Estimated to be more than 20,000.
The FDA was aware of problems with the device… what about Medtronic itself?
Turns out they did.
They knew battery packs could and were failing with some frequency.
They also knew that static electricity - a common hazard in any environment, was causing the devices to short-circuit.
They knew all of these things… and yet continued to sell the device.
Adding insult to injury, the FDA knew there were ongoing serious quality control issues with manufacturing at the factory. They found them in 2014, 2015, 2016, 2017, and 2018.
Yet, no penalties or other more serious regulatory action was taken until June 3, 2021, when the FDA finally warned healthcare providers to cease using the product.
How is it possible that a device so obviously flawed was allowed to be used when its dangers were so clearly known?
Troubling questions with no easy answers…
If you or a loved one has been harmed by a misdiagnosis, a medical procedure, a medical device, or a drug, call a qualified Connecticut medical malpractice lawyer. A knowledgeable medical malpractice attorney can help to ensure that your rights are protected.
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