Michigan Impella Heart Pump Lawsuit in 2024 (Latest Updates)

Quick Summary

• If you’re grappling with the complexities of the Michigan Impella heart pump lawsuit, this overview is designed to illuminate the broader legal landscape before delving into the specifics of the litigation.
• The article ahead offers a comprehensive examination of the Impella heart pump device’s legal challenges, including the grounds for the lawsuit, eligibility criteria for filing a claim, and insights into navigating the legal system in Michigan. For individuals or family members affected by the Impella pump, gaining clarity on your legal options is a pivotal step.
• If you or someone close to you has experienced adverse effects due to the Impella heart pump, the team at Schmidt & Clark, LLP, stands ready to support you. Distinguished for our expertise in representing plaintiffs, our primary goal is to help you achieve the justice and financial restitution you are entitled to.

How S&C Can Help With Your Claim?

S&C can help with your claim by providing expert legal representation against large corporations like Abiomed, ensuring that you are not alone in this daunting process. With our specialized experience in medical device litigation, we are well-equipped to advocate for those who have sustained injuries from the Impella Heart Pumps.

Though the legal journey can appear complicated, guided assistance can simplify the process. S&C assists you every step of the way, including:

• Compiling required documents
• Offering advice on eligibility
• Identifying the types of compensation claimants can seek.
• Providing free consultations to discuss potential Impella Heart Pump cases, giving affected individuals an opportunity to understand their legal options without any financial commitment.

Impella Heart Pump Lawsuit

Ironically, the Impella heart pump, a device engineered to assist the heart in pumping blood, has been linked to heart-wall tears and free-wall rupture, resulting in patient deaths. The issues were officially disclosed to the public in October 2021, triggering a series of legal events.

The FDA enacted an alert, its most drastic action, underscoring the severity of the situation and the potential for serious adverse health consequences.

What Is an Impella Heart Pump?

An Impella heart pump is a temporary blood pump and a ventricular assist device designed to support blood circulation in patients with coronary artery disease, cardiogenic shock, or those awaiting a heart transplant. It functions by aiding the heart’s ventricles, particularly the lower chambers responsible for pumping blood throughout the body. The pump catheter is a crucial element of the Impella heart pump system.

The device is frequently used for heart-related conditions, including heart failure, and during procedures such as percutaneous coronary interventions. A significant advantage of Impella is its insertion through a minor leg incision, thus removing the need for open heart surgery. However, despite its innovative design and functionality, the device has been linked to serious complications.

Reasons Behind The Recall

According to the FDAs 2023 notice, the affected Impella pumps are part of a recall due to the risk of the pump catheter cutting or perforating the wall of the left ventricle of the heart during operations, leading to catastrophic bleeding, death, and other serious adverse health consequences [1].

The FDA’s investigation into the devices led them to designate the Impella device recall as Class I, indicating the highest level of danger. The recall has affected nearly 7,900 heart pumps, specifically related to incompatibility issues with transcatheter aortic valve replacement stents.

The FDA’s warning letter to Abiomed highlighted risks, including diminished blood flow, pump cessation, blood flow death, and the infiltration of device fragments into the circulation. Abiomed also faced criticism for shortcomings in its quality management and device incident reporting procedures. The FDA alert emphasized extremely low survival rates post-tear, adding to the alarm.

Side Effects of Impella Heart Pump

The Impella heart pump is engineered to sustain optimal blood flow in patients dealing with coronary artery disease, those recovering from cardiogenic shock, or those awaiting a heart transplant. However, it has been linked to an increased risk of severe complications, including acute heart failure. This has resulted in an array of lawsuits filed due to severe injuries and deaths believed to be caused by the device during procedures such as transcatheter aortic valve replacement.

The Impella heart pump functions by taking over the left ventricle’s function, maintaining blood flow, and allowing the ventricle to rest, specifically after events of cardiogenic shock. The device aids blood flow during percutaneous coronary interventions, thus facilitating the procedures for patients with weakened heart function.

Stroke is one of the most common and serious complications of many MCSs, and Impella is no exception – Shunsuke Saito (M.D., PhD), Cardiovascular Surgeon at the Department of Cardiovascular Surgery, Osaka University

While it plays a critical role in maintaining circulation during cardiogenic shock, the device also bears significant risks.

Impella heart pump users have reported severe complications such as left ventricle perforation, severe hypertension, and lack of blood flow. Reports and lawsuits have described injuries and fatalities due to device failures, necessitating corrective surgeries, and other serious interventions.

The FDA has identified risks such as diminished blood flow or total pump cessation and fragmented blade pieces entering the bloodstream, which are attributed to defects like a damaged purge sidearm. Vulnerable groups that are particularly susceptible to the risks of the Impella pumps include older individuals, women, and those with pre-existing heart conditions or anterior infarction.

The alarming part is that there have been 129 reports of serious injuries and 49 deaths associated with the recalled Impella heart pump.

How Do You Qualify for an Impella Heart Pump Lawsuit?

To qualify for an Impella heart pump lawsuit, you must have been affected by the device’s complications. The recent news of the Impella heart pump’s issues has understandably caused distress and uncertainty among patients and their families.

However, the silver lining lies in the availability of legal options. Those who have suffered as a result have begun filing lawsuits against Abiomed, the manufacturer of the Impella heart pump.

The Status Of The Impella Heart Pump Lawsuit Litigation in Michigan

The Impella Heart Pump Lawsuit in Michigan has been a hot topic in medical device litigation. Abiomed faces allegations of not providing sufficient information to medical professionals about the potential malfunction of Impella heart pumps during procedures.

Michigan has a unique set of laws and regulations that govern product liability actions. The state has a statute of limitations of three years for such actions, including those related to medical devices like the Impella heart pumps. Michigan plaintiffs dealing with products that have been in use for more than ten years must furnish evidence without relying on legal presumptions of defectiveness.

Cases of severe injury and death associated with the use of the Impella Left Sided Blood Pumps have been reported. These associations have led to wrongful death claims, covering funeral expenses and loss of income. Extreme injuries, including brain damage due to impeded blood flow, have been reported, with some cases requiring cardiac surgery to remove the device or its fragments.

Impella Heart Pump Lawsuit Settlement Amounts in Michigan

Past settlements and current trends in medical device litigation significantly influence the potential outcome of the Impella heart pump lawsuits. For instance, in March 2018, Abiomed settled for $3.1 million over allegations related to improper marketing practices. This, along with the increasing scrutiny of expert testimony and the rise in personal injury lawsuits against manufacturers, may influence the course of the Impella heart pump lawsuits.

If you are eligible for an Impella heart pump lawsuit, you might be curious about the potential compensation you could receive. Plaintiffs in an Impella heart pump lawsuit may be entitled to compensation for past and future medical care, loss of earnings, and physical and emotional suffering.

Types of damages that you can recover include:

• Medical expenses, such as hospital bills, costs of surgeries, medications, and therapy
• Compensation for lost wages due to missed work
• Potential future loss of income resulting from the injury

Furthermore, the potential damages encompass compensation for physical pain resulting from the injury and reimbursement for emotional distress, both of which could be considered adverse health consequences.

Filing an Impella Heart Pump Lawsuit in Michigan

If you or a loved one has been affected by the Impella heart pump and you’re considering legal action, the first step is to file a lawsuit. Current litigation for the Impella Heart Pump Device in Michigan is ongoing, and new clients who have encountered complications are being accepted.

Types of Evidence To Present

Evidence is crucial when filing a lawsuit. To be eligible, you must show that a defect in the Abiomed Impella heart pump directly caused an injury. This includes maintaining the Impella heart pump in its original state post-incident to prove that the injury resulted from a product defect.

Gathering medical records, photographs, videos, and witness statements can help build a strong evidence foundation for your claim.

What is the Statute of Limitations for the Impella Heart Pump Lawsuit in Michigan?

The statute of limitations for the Impella heart pump lawsuit in Michigan is three years, which means you have three years from the date of the injury to initiate legal proceedings. If you’re considering taking legal action, it’s critical to do so without delay.

Related Article: Medtronic SynchroMed Infusion Pump Lawsuit

See all related medical device lawsuits our attorneys covered so far.

Get Your Free Consultation From Michigan Our Lawyers

At Schmidt & Clark, LLP we stand by your side in these difficult times. Should you or someone you cherish face hardships due to the Impella heart pump, we invite you to reach out. Our adept team is well-versed in such cases and will navigate you through each step of the legal maze.

We are committed to providing clear insights into your legal entitlements and determining your qualifications for a lawsuit. Our consultations are offered at no cost, and our fees are contingent upon securing a victory for you.

You can trust in our commitment to serve you with the compassion we would extend to our family members. Contact us for a comprehensive review of your case.

References:

1. https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-all-impella-left-sided-blood-pumps-risk-motor-damage-after-contact-transcatheter