In August 2021, the United States Food and Drug Administration issued a Class I Recall of all Medtronic HeartWare Ventricular Assist Device (HVAD) System due to “an increased risk to neurological adverse events and mortality” associated with usage of the device, which may also randomly stop functioning.
A Class I Recall is the most serious type of recall available for the FDA to issue and represents a call for immediate stoppage of a product’s manufacturing and use due to serious and dangerous issues. In light of the FDA’s recall, thousands of Americans who have received Medtronic HVAD devices may be at risk for serious injuries.
When injuries occur due to a defective product such as this one, victims may be eligible to receive compensation from the device’s manufacturer for their injuries. Our legal representation team at Bailey Glasser is ready to act in response to the Medtronic HVAD recall, and if necessary, begin filing lawsuits against Medtronic on behalf of victims.
Medtronic HeartWare Ventricular Assist Device
The Medtronic HeartWare Ventricular Assist Device (HVAD) System is a surgically implanted medical device that assists patients who have been diagnosed with chronic heart failure. The HVAD device is attached to the heart and assists the left ventricle, a muscle within the heart, in pumping blood to the rest of the body. A pumping device is surgically attached to the heart, while a controller device outside the body is connected to the pump via a tube that is inserted through a patient’s skin.
The device is marketed for use as a “bridge-to-transplant” device, to be used on a temporary basis while a patient is awaiting a full heart transplant. Otherwise, the device is used to improve the quality of life in end-stage heart failure patients who may not be able to receive a heart transplant. The FDA approved the Medtronic HVAD for use in the United States in November 2012, and it was installed on thousands of patients in the 10 years before its recall in 2022.
FDA Recall of the Medtronic HeartWare HVAD
In June 2021, the FDA first communicated that Medtronic had stopped selling and manufacturing the HVAD due to “an increased risk of neurological adverse events and mortality associated with the internal pump,” and “a potential for the internal pump to stop.” According to the FDA, these issues could lead to death or very serious injury, and the FDA advised healthcare providers to stop using the Medtronic HeartWare HVAD on future patients. The FDA did not advise healthcare providers to remove the device from existing patients, and even wrote that “elective removal is not recommended at this time.”
Then, in August 2021, the FDA identified the issues associated with the Medtronic HeartWare HVAD as a Class I Recall, which is the most serious type of recall used by the FDA. But even with the recall, the FDA did not revise its recommendations from June 2021, including that elective removal of Medtronic HeartWare HVAD devices was not recommended. Before the Class I Recall was issued, almost 100 injuries and 15 deaths were reported for various reasons associated with Medtronic HVAD devices. Today, most concerns about HVAD stem from an identified “welding defect” with specific effects on the device.
Welding Defects in the Medtronic HeartWare HVAD
Most recently, in April 2022, the FDA made a third communication about the Medtronic HeartWare HVAD, writing to healthcare providers that a “welding defect’ in the internal pump may present as pump thrombosis, or a pump clot, in patients using the Medtronic device. The FDA continued to restate its position that elective removal was not recommended and that providers should report all issues to Medtronic and the FDA.
The FDA’s most recent announcement could have serious legal ramifications for Medtronic, as it identifies a specific design defect in the HVAD. If patients begin suffering injuries due to that defect, Medtronic could be liable to pay for damages in very large amounts. Currently, the manufacturer has opened an internal investigation to determine how the welding defect may affect the pump’s function and whether current users may be in danger.
According to the FDA and Medtronic, patients who may have issues related to the HVAD’s welding defect will present with the following symptoms:
- Grinding sound on the HVAD device
- Transient power spikes on log files and High Watt alarms on the controller device
- Elevated lactate dehydrogenase levels
- Low motor speed, resulting in low perfusion
- Dizziness or lightheadedness
Medtronic HeartWare HVAD Lawsuits
A 2021 report published by ProPublica revealed that the FDA and Medtronic may have been aware of the issues associated with the HeartWare HVAD long before they came to light. According to ProPublica, the FDA had received more than 3,000 reports of patient deaths linked to HeartWare HVAD issues by the end of 2020, and the agency still refused to advise that the devices should be removed from patients.
The ProPublica report also highlighted a history of defects and recalls associated with HeartWare devices, including recalls unrelated to the Class I Recall issued most recently by the FDA. In short, it has become readily apparent that Medtronic knew or should have known that its HeartWare HVAD devices were not safe for usage, and it completely failed to act to protect patients and consumers.
Pursuing Compensation for HeartWare HVAD Victims
If you or a loved one has experienced a serious injury or death that may be linked to a Medtronic HeartWare HVAD device, you and your family may be entitled to receive compensation for your injuries. Because HeartWare HVAD information has just recently come out, lawsuits are just now beginning to be filed in courts across the country.
Our team of experienced personal injury lawyers at Bailey Glasser is investigating Medtronic claims every day, and if you believe you may have a claim for compensation, you should contact us as soon as possible.
A personal injury lawsuit is designed to compensate victims of wrongdoing for the injuries they suffered due to another person or entity’s negligence or wrongful actions. Compensation may be available for Medtronic HeartWare HVAD victims from any of the following sources:
- Lawsuits filed individually against Medtronic
- Class action lawsuits
- Multi-district litigation proceedings
- Arbitration and mediation
Even though class actions and multi-district litigation proceedings have not yet been established, they may be set up in the future. Our attorneys are monitoring developments in these new cases every day, and we can assist you in determining if and when you should make your own claim for compensation from Medtronic.
How Much is a HeartWare HVAD Lawsuit Worth?
Every lawsuit is worth a different amount of money, depending on the specific injuries suffered by the plaintiff. In general, the damages that may be recovered in a personal injury lawsuit are designed to fully and fairly compensate an injured party for the costs incurred because of their injuries. The types of damages that may be available in a Medtronic HeartWare HVAD lawsuit include:
- Medical costs of removing and replacing the device
- Lost wages associated with device issues
- Pain and suffering
- Funeral expenses and loss of income in death cases
- Loss of companionship for spouses and family members
Additionally, punitive damages may be available in cases involving especially wrongful conduct. At this point, however, there is not sufficient evidence to determine whether Medtronic may be liable for punitive damages, but as more evidence comes to light, punitive damages can and will be sought where applicable.
Who Can File a HeartWare HVAD Lawsuit?
Compensation for injuries sustained due to a defective HeartWare HVAD device can be sought by a victim who is still living or the family members of a victim who has passed away due to injuries associated with the device. Because the HeartWare HVAD has so many documented defects, any patient who has been implanted with an HVAD and later experienced medical issues should contact our team to discuss the possibility of filing a lawsuit.
Our team of attorneys at Bailey Glasser has extensive experience dealing with personal injury cases involving both living victims and wrongful death situations, and we will handle your case accordingly if we are able to take on your representation.
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At Bailey Glasser, our attorneys excel in the field of personal injury law, tackling challenging cases such as Medtronic HeartWare HVAD lawsuits, RoundUp Lawsuits, and Transvaginal Mesh Lawsuits. Our nationwide team of legal professionals possesses the expertise, experience, and resources necessary to confront formidable corporations like Medtronic, an endeavor we engage in daily.
With the evolving landscape of lawsuits, including those related to Long COVID Long Term Disability, it’s vital to have a team of attorneys capable of navigating these complex territories and advocating justice for you. Should we undertake your family’s case, we’ll pursue justice to the fullest extent allowed by law, maintaining your interests as our utmost priority.
We offer free consultations to prospective clients, and we’re ready to hear from you today. Contact us now to set up an appointment with a member of our team.