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FDA allowed dangerous heart pumps to be implanted in thousands of Americans

ProPublica recently released an investigative report on the serious defects of the HeartWare Ventricular Assist Device (HVAD). This is an electronic heart pump produced by Medronic which allows a compromised heart to regain normal function. It is often used as a transitional implant for patients on a waiting list to receive a heart transplant.

Long history of dangers

The Food and Drug Administration (FDA) operates a division known as the Center for Devices and Radiological Health. This division is tasked with ensuring the safety of high-risk medical devices. The FDA first discovered serious malfunctions with the HVAD back in 2014, which had led to the deaths of multiple patients. These included:

  • Faulty batteries – which caused the device to stop working and prevented the alarm from sounding – to alert the patient about the malfunction
  • Short circuits – which led to fatal electrocutions of patients
  • Internal tube tears – which caused fatal internal bleeding

Insufficient action

In June of 2014, upon discovering these malfunctions, the FDA issued a warning letter to Medtronic, giving the company 15 days to resolve the safety issues. However, the problems continued. Rather than taking decisive action to seize the products or order injunctions against the company, the FDA chose to let Medtronic voluntarily fix the problems.

To date, more than 19,000 patients across the United States have received the HVAD implant – most of them after the FDA initially discovered the problems. The reports of patient deaths and manufacturing issues have continued to grow. Finally, in June of this year, Medtronic halted sales and implants of the HVAD.

Recourse

The public relies on the FDA to ensure the safety of virtually any product we consume. The FDA failed the public in their duty, in this case. Medtronic also holds responsibility for continuing to manufacture high-risk medical instruments that were known to be defective. Medtronic and HeartWare have settled multiple lawsuits for the wrongful deaths of HVAD patients.

If you or someone you love has suffered from a faulty HVAD implant. It’s important to discuss your case with an experienced medical malpractice attorney. You may be entitled to restitution under the law.

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