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New Jersey 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

  • If you’re searching for information on the New Jersey Impella heart pump lawsuit, understand this: allegations of serious harm caused by potentially defective Impella heart pumps have prompted legal action. New Jersey residents are filing lawsuits and seeking accountability and compensation from the pump manufacturer, Abiomed.
  • This article provides the latest updates on the suit, explores the legal claims involved, and discusses how affected parties can join the litigation.
  • If you or a loved one has experienced adverse effects from the use of the Impella heart pump, the legal team at Schmidt & Clark, LLP, stands ready to support you. Recognized for our expertise in representing plaintiffs, we are dedicated to ensuring that you receive the justice and financial restitution to which you are entitled.

How S&C Can Help With Your Claim?

S&C can help with your claim by providing expert legal advice, guiding you through the complex legal process, and representing your interests in court. We understand the emotional and physical toll that a defective medical device can take on you and your family, and we are committed to seeking the justice and compensation you deserve.

Here’s how we can assist you:

  • Providing expert legal consultation to understand the nuances of your case.
  • Conducting a thorough investigation to gather all necessary evidence.
  • Delivering aggressive representation to advocate for your rights in court.

Impella Heart Pump Lawsuit

When it comes to heart surgery, precision and reliability are paramount. This is why the legal matters surrounding the Abiomed Impella heart pump in New Jersey have garnered attention within the medical community and among the public. Individuals and their families who have encountered complications with these heart pumps are seeking legal avenues to address their concerns.

The legal proceedings involve product liability lawsuits in cases of adverse outcomes and the potential for medical malpractice claims, reflecting the complexity of these issues.

The heart of these Impella heart pump lawsuits lies in the claim that these defective medical devices, designed to provide crucial support during heart surgery, were defective and that their malfunctions have had devastating effects. As more individuals come forward, the scope of these lawsuits is expanding, illuminating the gravity of the situation and the urgency for legal remedy.

What Is an Impella Heart Pump?

An Impella heart pump is a sophisticated medical device designed to assist in maintaining the heart’s pumping function during cardiac procedures. The Impella heart device is intended to be left in place for up to 14 days in patients who suffer acute heart failure in one side of the heart after a heart attack or heart procedure such as heart catheterization, valve replacement, or other surgery.

The Impella heart pump stabilizes the patient’s hemodynamics by providing temporary circulatory support, offering a vital lifeline during critical times. This device has played a significant role in cardiac surgery, offering hope and improved outcomes for individuals facing life-threatening heart conditions.

Reasons Behind The Recall

According to the FDA, for patients in New Jersey with heart pumps implanted in their chests, the news of a recall of the Impella devices was no doubt alarming. With over 7,895 units of the Abiomed Impella heart pump covered in the recall, the potential for ill effects is considerable [1].

Abiomed initiated the recall due to the risk of the pump catheter causing damage to the left ventricular wall during surgical procedures, as indicated in the recall notice.

The FDA’s recall notice specifically mentions 466 units of the Impella 5.5 with SmartAssist, highlighting the scale of this issue.

Those with affected Impella pumps, especially during certain procedures or with specific heart conditions, may be at risk and should be aware of their options, including potential legal recourse.

Identifying whether your Impella heart pump is part of the recall is the first step in safeguarding your health.

According to the Society of Thoracic Surgeons, the recalled models span across the Impella range, including [2]:

  • Impella 2.5
  • Impella CP
  • Impella CP with SmartAssist
  • Impella 5.0
  • Impella 5.5 with SmartAssist
  • Impella LD

All are distributed within a specific timeframe. Patients can cross-reference their device’s details with the FDA’s recall database, which includes specific product names and codes to confirm if their device is affected.

Additionally, Abiomed’s Urgent Medical Device Correction letter, released on December 27, 2023, should have reached affected individuals, providing further guidance on identifying and addressing recalled devices.

In response to the recall, Abiomed issued an Urgent Medical Device Correction letter due to severe injury, lack of blood flow, or death risks from Impella Left Sided Blood Pumps. The FDA classified this as a Class I recall, the most critical type. Abiomed’s updated guidance to healthcare facilities includes use restrictions and imaging protocols to prevent heart wall punctures, which have been central to the litigation.

Side Effects of Impella Heart Pump

The injuries reported due to complications with the Impella heart pumps are not minor; they are profound and life-altering. Heart wall tears, a serious adverse health consequence, have been associated with the use of the Impella CP heart pump in critically ill patients.

In some instances, the severity of complications, such as:

  • free wall rupture
  • left ventricle perforation
  • necessitated open-heart surgery
  • an invasive intervention to address the damage

These adverse events paint a grim picture of the potential risks associated with the device, including serious adverse health consequences.

With a total of 179 complaints and three injuries explicitly linked to the FDA’s recall, the reported injuries underscore the gravity of the situation and the importance of these lawsuits in seeking justice for those affected.

Ventricular perforation is a rare complication during a high-risk percutaneous coronary intervention (PCI) when supported by Impella® (Abiomed). However, instrumentation of the left ventricle several days after transmural infarct potentially increases susceptibility for perforation – Ismael A Salas de Armas (MD), Assistant professor at McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)

How Do You Qualify for an Impella Heart Pump Lawsuit?

To qualify for an Impella heart pump lawsuit, you must first establish whether you meet the eligibility criteria. If you have suffered serious injuries, or tragically, if a loved one has died due to the use of Impella Left Sided Blood Pumps, you may have grounds to file a claim.

It is particularly important to note the timeframe for eligibility: those who had an Impella Heart Pump Device implanted between October 10, 2021, and October 10, 2023—the period covered by the recall—are strongly encouraged to consider their legal options.

The eligibility extends to a diverse group, including elderly individuals, women, and those with specific heart conditions such as anterior infarction who may be more susceptible to the device’s complications.

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

The legal landscape surrounding the Impella heart pump lawsuits in New Jersey is evolving as more cases are being filed. These lawsuits are in various stages, with some still in the process of gathering evidence while others may be gearing up for settlement discussions or trial.

As affected parties come forward, the consolidation of cases into multidistrict litigation (MDL) is a possibility that could streamline the legal process and provide a more efficient path to resolution for all involved.

The courts are currently overseeing the pre-trial proceedings, which involve the exchange of information between the parties during discovery, the submission of expert witness testimonies, and pre-trial motions that will set the stage for how the lawsuits will proceed.

New Jersey’s legal system is diligently managing these complex cases, ensuring that the rights of those impacted by the Impella heart pumps are adequately represented.

Impella Heart Pump Lawsuit Settlement Amounts in New Jersey

Understanding the financial implications of a lawsuit is crucial for claimants considering legal action against Abiomed over the Impella heart pump.

While each case is unique, and settlement amounts can vary widely based on individual circumstances, it’s important to recognize the types of damages that might be included in a settlement.

In New Jersey, the compensation could cover medical expenses, lost wages, future earning capacity, pain and suffering, and punitive damages if egregious negligence is found. It’s also possible for families of deceased patients to receive compensation for wrongful death, including funeral expenses and loss of companionship.

The settlement amounts in these cases are often kept confidential. Still, they are typically determined by the severity of the injuries, the impact on the claimant’s quality of life, and the strength of the evidence presented.

Filing an Impella Heart Pump Lawsuit in New Jersey

As the lawsuits against Impella heart pumps proceed, the evidence presented becomes the linchpin of the case.

Establishing the liability of Abiomed through negligence is key, which involves demonstrating the causal link between the defective Impella heart pump and the injury or blood flow death of the patient.

Types of Evidence To Present

This evidence forms the core narrative of each lawsuit, painting a picture of the patient’s journey from implantation to the adverse effects suffered.

The types of evidence you can present in court include:

  • Documenting Injury or Death: Medical records are essential to show the harm caused by the Impella device, especially in severe cases requiring additional surgeries.
  • Expert Testimonies: Authorities in medical standards and device functionality offer critical insights that can substantiate the plaintiff’s claims.
  • Medical Records: Detailed accounts of the patient’s treatment and complications help to establish the direct impact of the device.
  • FDA Reports: These documents are crucial as they reflect the regulatory body’s stance and the manufacturer’s compliance issues.
  • Manufacturer Communications: Communications between Abiomed and the FDA, especially regarding device corrections and updates, are key to proving liability.

What Is the Statute of Limitations for the Impella Heart Pump Lawsuit In New Jersey?

The statute of limitations for the Impella heart pump lawsuit in New Jersey is two years from either the date the injury occurred or the date when the injury should have been reasonably discovered. Adhering to this time frame is crucial for claimants, as it dictates their ability to pursue legal action and obtain compensation.

Failure to file within this period may result in the loss of the right to seek justice and claim damages from the manufacturer. Therefore, it is imperative for individuals affected to seek legal advice without delay and proceed with filing their claim to meet the statutory requirements.

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At Schmidt & Clark, LLP we stand with you in these trying times. Should you or your family be affected by the adverse effects of the Impella heart pump, we encourage you to get in touch. Our seasoned legal professionals are well-versed in such matters and will navigate you through every step of the legal process.

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Reference:

    1. https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-all-impella-left-sided-blood-pumps-risk-motor-damage-after-contact-transcatheter
    2. https://www.sts.org/news/fda-announces-class-i-recall-abiomed-impella-instructions-use-left-sided-blood-pumps

 

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