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New York Impella Heart Pump Lawsuit (2024 Update)

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C.L. Mike Schmidt Published by C.L. Mike Schmidt

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Quick Summary

  • Confronted with severe complications, New Yorkers are taking legal action against the manufacturers of Impella heart pumps. This article provides a straightforward overview of the ongoing New York Impella heart pump lawsuit, the serious allegations at hand, and what these developments mean for potentially affected patients.
  • If you or someone close to you has experienced adverse effects from the Impella heart pump, Schmidt & Clark, LLP, stands ready to support you. As a firm with a distinguished reputation in representing plaintiffs, our paramount goal is to ensure that you secure the compensation and justice that you are entitled to.

How S&C Can Help With Your Claim?

S&C can help with your claim by offering expert legal guidance if you have suffered from complications associated with the Impella heart pump.

 Our experienced legal team offers guidance on product liability claims, focusing on:

  • Expertise in medical device litigation
  • A track record of securing client compensation
  • Diligent pursuit of justice for your case

Impella Heart Pump Lawsuit

According to The Society of Thoracic Surgeons, the Abiomed Impella heart pump, which is intended to assist heart function during high-risk procedures and severe heart conditions, has become the focus of legal scrutiny. Reports indicate that at least 49 deaths and over 120 serious injuries may be associated with the use of Abiomed’s Impella Left Sided Blood Pumps [1].

These lawsuits are part of ongoing investigations into claims of serious injury or death associated with the usage of Abiomed Impella heart pumps. The allegations primarily revolve around device malfunctions leading to reduced blood flow, heart wall perforation, and device failure, thereby causing serious health consequences.

What Is an Impella Heart Pump?

An Impella heart pump is a small device, often likened to a “heart in a pump catheter,” that is inserted through the femoral artery without the need for surgery. It is designed to help the heart pump blood during percutaneous coronary interventions (PCI) and to support patients recovering from cardiogenic shock by assisting with blood flow through the ventricles.

This device’s primary function is to take over the left ventricle’s pumping action to maintain blood circulation. Notably, the Impella pump also relays information about the heart’s functioning and the volume of blood being pumped to an external console for real-time monitoring.

Just like a faulty engine can cause a car to crash, a malfunctioning heart pump can have catastrophic consequences. One of the major allegations against the Impella heart pump is that its malfunctions can lead to reduced blood flow and heart wall perforation.

A specific defect in the affected Impella pumps, a damaged purge sidearm, significantly increases the risk of fluid leakage. This could lead to severe risks such as ventricular wall perforation, severe hypertension, and a lack of blood flow, ultimately causing high rates of in-hospital mortality and major complications.

Additionally, the Impella heart pump supports the circulatory system by assisting with blood flow through the heart’s ventricles, thereby temporarily reducing the workload of the heart’s ventricles in various high-risk procedures and conditions.

Reasons Behind The Recalls

The FDA issued its most serious alert for Impella devices, including the Impella CP left-sided heart pump, and criticized the manufacturer, Abiomed, for not disclosing the associated risks in a timely manner.

Abiomed recalled the instructions for use for Impella left-sided blood pumps due to risks of left ventricle perforation and sent out an urgent medical device correction letter.

According to the FDAs 2023 notice, Class I recalls, which indicate a reasonable chance that a product will cause serious adverse health consequences or death, were issued for Impella devices due to risks such as device breaking or internal leaks occurring during a surgical procedure [2].

A Class I recall is not just a recall but a serious alert. It denotes that there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death, potentially leading to adverse events.

Impella devices were subject to Class I recalls due to risks such as device breaking or internal leaks during a surgical procedure.

If the device were to break or leak during an operation, the patient could suffer severe consequences, including:

  • Reduced blood flow to critical organs
  • Complete stop of the pump
  • Severe heart attacks
  • Other life-threatening conditions.

A total of 129 reported instances of serious injuries related to the use of Impella pumps, with 49 of these incidents resulting in death, further accentuating the seriousness of the situation. Despite the FDA’s highest level of approval for safety and efficacy, Impella devices have been a source of significant distress for many patients.

Serious Injuries as Side Effects of Impella Heart Pump

Despite its high-tech features, the device is not without risks, including:

  • bleeding
  • vessel damage
  • heart damage
  • organ failure
  • infection
  • arrhythmias
  • potentially death.

On the surface, the Impella heart pump is a medical marvel. It’s used for:

  • Short-term support during high-risk catheter-based procedures
  • Severe heart attacks
  • Cardiogenic shock
  • Open-heart surgeries

The pump is designed to be inserted through the femoral artery via a catheter and positioned to pump blood from the left ventricle into the aorta, thereby providing hemodynamic stability.

Notably, each Impella pump model offers distinct levels of circulatory support tailored to the severity of heart failure or procedural needs.

However, despite these benefits, patients undergoing procedures with Impella Left Sided Blood Pumps, particularly the elderly and women, may be more susceptible to the device’s side effects.

Peripheral vascular events are another well-known complication associated with Impella support. Patel et al. studied 31,263 patients who underwent Impella support and found that 13.5 % of the patients had vascular complications, among whom 56 % required surgical treatment – Dr. Nilay Patel, Interventional and Structural Cardiologist at Massachusetts General Hospital and an Instructor at Harvard Medical School

How Do You Qualify for an Impella Heart Pump Lawsuit?

To qualify for an Impella heart pump lawsuit, one must demonstrate with evidence that a defect in the device was the direct cause of injury or death.

These lawsuits allege that the devices are defective, potentially leading to serious injuries or deaths due to inadequate medical device safety.

Affected parties are seeking compensation through legal action against manufacturers, distributors, or healthcare providers on the grounds of product liability, medical malpractice, or inadequate warnings.

The implications of the recalled instructions for using the Impella heart pump can significantly impact the lawsuit. Proving that the recalled instructions were deficient is critical in lawsuits, as plaintiffs must establish that these instructions directly caused injury or death. Evidence must show how the device’s defect, such as a damaged purge sidearm increasing leakage risk, caused the patient’s fatality.

The Status Of The Impella Heart Pump Lawsuit Litigation in New York

The cases in New York involve accusations of the Impella heart pumps causing perforation of the heart.

This information serves as a reminder that the battle for justice is ongoing and that the stories of victims are being heard and represented in court.

It means their grievances are being acknowledged, and justice is being sought. Patients who have experienced heart wall tears due to an Impella heart pump may be eligible to participate in a lawsuit against Abiomed.

This is a clear indication that the voices of those affected are resonating in the legal corridors, shaking the foundations of the manufacturers of these devices.

Impella Heart Pump Lawsuit Settlement Amounts in New York

A crucial question on the minds of victims is the potential settlement amount in these lawsuits. Victims of the Impella heart pump in New York may be entitled to financial compensation for medical costs and lost wages.

When we talk about potential damages recoverable in Impella lawsuits, it’s not just about compensating economic losses such as medical expenses and lost wages.

Non-economic damages, such as pain and suffering, emotional distress, and psychological trauma resulting from experiences with the Impella Heart Pump, can also be claimed. This broad scope of potential damages ensures that victims are compensated holistically for their ordeal.

Filing an Impella Heart Pump Lawsuit in New York

The process of filing a lawsuit might seem daunting, but with the right guidance, it can be manageable. In New York, filing an Impella heart pump lawsuit requires action before the statute of limitations expires, which varies by state.

Types of Evidence To Present

Presenting the right evidence is key to winning a lawsuit. In an Impella heart pump lawsuit, evidence could include reports of device malfunctions such as heart tears and pump stoppages and medical records documenting serious injuries or death related to the use of the device.

Expert testimony may be used to establish a product defect and demonstrate how it caused injuries. Documentation proving the malfunction of the Impella device during heart valve replacement surgery may also be critical evidence.

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

The statute of limitations for the Impella heart pump lawsuit in New York is three years from the date of injury caused by the medical device. Affected individuals must begin legal proceedings within this timeframe.

The statute of limitations requires timely filing, and exceptions may alter the filing period. It’s crucial to consult with a lawyer to understand these nuances and avoid any legal pitfalls.

Related Articles:

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

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Schmidt & Clark, LLP stands with you in these trying times. Should you or someone you cherish face complications stemming from the Impella heart pump, we urge you to get in touch.

Our seasoned team is well-versed in such matters and will navigate you through the intricacies of the legal process. We’re committed to enlightening you about your legal entitlements and determining your qualifications for a lawsuit.

Our initial consultation is free, and we operate on a contingency fee basis, meaning we get paid only if we win your case. You can count on us to handle your case with the compassion and attentiveness we would afford our kin. For a comprehensive review of your case, don’t hesitate to get in touch with us without delay.



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