Medtronic HVAD Lawsuit Alleges Heart Pump Malfunctioned and Failed to Restart, Resulting in Fatal Injury
A Missouri woman has filed a wrongful death lawsuit against Medtronic, claiming the defective design of a HeartWare Ventricular Assist Device (HVAD) system caused her husband to suffer fatal injuries after the heart pump malfunctioned and failed to restart.
The complaint (PDF) was filed by Beth Morris in the U.S. District Court for the Eastern District of Missouri on June 17, pursing claims over the the loss of her husband, Michael Morris.
The Medtronic HVAD system was first introduced in 2012, to help pump blood from the heart to the rest of the body among individuals awaiting a heart transplant, who are at risk of death from end-stage left-ventricular heart failure. The system includes a pump implanted in the space around the heart, with a controller that regulates the speed and function of the pump.
Last summer, the FDA announced Medtronic was removing its HVAD systems from the market, due to an unreasonable risk of neurological events and increased death rates among patients. However, many individuals still had the device implanted, and the FDA did not recommend that they have the Medtronic HVAD removed at the time, if there were no problems detected.
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Michael Morris’s HVAD system was part of a recall announced by the FDA early last year, due to problems with impellers that may cause the pumps to fail to start, or restart after stopping, increasing the risk of serious injury or death for patients relying on the devices to keep their heart pumping. However, the lawsuit claims Morris never received any notice of the Medtronic HVAD recall.
According to the complaint, Morris originally had an HVAD system implanted in July 2018, received a replacement system in November 2019, and was hospitalized in February 2021, due to an impending battery failure. However, his doctors report that once the pump stopped, they couldn’t get it to start up again.
Following 10 failed attempts to restart the device, Morris was discharged to hospice and died on March 4, 2021. The lawsuit indicates that when the pump failed to restart, the medical staff had no choice but to send Morris home to die, all of which resulted from changing the battery.
Medtronic HVAD Problems
Prior to removing the Medtronic HVAD from the market, the system was linked to more Class I FDA recalls than any other high-risk medical devices, suggesting that the agency believed risks identified in each of the 15 recalls indicated that patients were at risk of severe injury or death.
According to an August 2021 investigation by ProPublica, FDA inspectors began voicing concerns about Medtronic HVAD systems as early as January 2014, following a HeartWare recall in late December 2013, which was issued because the device could fail and stop pumping, leading to serious injury and death.
FDA investigators issued a warning letter a month later, after identifying a number of deficiencies at the HeartWare manufacturing facility in Miami Lakes, Florida, particularly involving the process for making sure that some corrections made to the HVAD actually work.
The ProPublica investigation lay the blame at the FDA’s feet, saying the agency allowed more than 19,000 patients to be implanted with the heart pump, most of whom received their implants after the FDA had determined the HeartWare HVAD did not meet federal safety standards.
When the devices were removed from the market in June 2021, the FDA indicated it had received more than 3,000 reports of patient deaths by the end of 2020, all linked to HeartWare implant problems.
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