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Colorado Impella Heart Pump Lawsuit (2024 Update)

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Quick Summary

  • The Colorado Impella heart pump lawsuit has raised significant concerns, highlighting the potential for severe patient harm due to device malfunctions. Focusing on patient safety and legal advocacy, the lawsuit seeks to address the alleged failure of the device’s manufacturer to adequately warn patients and healthcare providers of the risks associated with its use.
  • This article serves as a comprehensive guide detailing the scrutiny of the medical device, the legal rights of the injured, and the steps for filing a compensation claim.
  • If complications from the Impella heart pump have impacted you or someone close to you, Schmidt & Clark L.L.P. stands ready to support you. Our firm is recognized for our expertise in representing plaintiffs, and we are committed to helping you secure the justice and compensation you are entitled to.

How S&C Can Help With Your Claim?

S&C can help with your claim by offering their legal expertise to individuals who intend to file Impella heart pump lawsuit claims. The firm leverages its extensive experience in representing clients who have encountered complications from medical devices, aiming to clarify the complex litigation process and provide personalized support to ensure clients can navigate the legal system with ease.

If you have incurred injuries or losses due to a faulty Impella heart pump, S&C could assist you in claiming the maximum possible compensation.

We can guide you through the litigation process, advocating for your compensation, and help you secure remuneration for:

Impella Heart Pump Lawsuit

The Impella Heart Pump lawsuit has sent shockwaves through the medical community. The F.D.A. issued a Class I recall for the Abiomed Impella Heart Pump Device, linking it to increased risks of serious injury, complications like free wall rapture, and multiple deaths.

An Impella Heart Pump is essentially a high-tech lifeline, a temporary implant crafted to ensure the heart maintains adequate blood flow for patients grappling with coronary artery disease, in recovery from cardiogenic shock, or on the waitlist for a heart transplant.

Abiomed’s promotional materials represented and claimed that the device was suitable for uses that were still being evaluated under the Protect II and Recover II IDE studies, which was in breach of F.D.A. guidelines.

What Is an Impella Heart Pump?

The Impella Heart Pump is a medical device designed to support patients with conditions ranging from coronary artery disease to those awaiting heart transplantation. But it’s more than just a pump. It’s a lifeline for those with heart conditions. Let’s delve deeper into its design, operation, and the reasons behind its recall.

The device in the spotlight of the lawsuit, the Impella 2.5, is officially known as the Impella Recover LP 2.5 and is Abiomed’s flagship product.

The Impella heart pump is placed into the heart by inserting a catheter through a small incision in the upper thigh into the femoral artery. The catheter is then advanced until it reaches the left ventricle.

The Impella heart pump draws blood from the left ventricle and ejects it into the aorta. This facilitates the circulation of oxygenated blood throughout the body, reducing the heart’s workload and oxygen consumption.

The pump functions through continuous axial flow, offering stable performance even during heart rhythm disturbances.

The Impella heart pump is a vital tool for supporting patients with coronary artery disease, those recuperating from cardiogenic shock, and patients awaiting heart transplantation.

During high-risk percutaneous coronary interventions, which involve opening blocked coronary arteries, the Impella heart pump is used to maintain blood flow, proving crucial for patients with critical blockages, weak heart muscles at high risk, or acute heart failure.

The Impella device plays a pivotal role for patients suffering from heart attacks and shocks. It provides support to the heart, enabling it to rest and recover.

It also offers temporary right ventricular support for up to 14 days for patients with a body surface area of at least 1.5 square meters, supporting blood flow above 4.0 liters per minute.

In cases of simultaneous left and right heart failure, a combination of left-sided and right-sided Impella devices can manage these complex cardiac conditions.

Reasons Behind The Recall

According to the Society of Thoracic Surgeons, the F.D.A. issued its highest-level alert for the Impella CP heart pump after it was linked to 49 deaths and 129 injuries, specifically citing the risk of heart wall tears and punctures [1].

The FDA’s warning revealed an elevated risk of mortality among patients using Impella heart devices, particularly those with unstable medical conditions.

Furthermore, certain groups, such as older adults, women, and individuals with pre-existing heart conditions, are at increased risk of complications when using the Impella heart pump.

Abiomed was found to have the following:

  • Created an internal bulletin in October 2021 addressing the tearing risk
  • Failed to report this within 10 days to the FDA
  • Numerous complaints remained unreported

The FDA then issued a Class I recall for Abiomed’s Impella Left-Sided Blood Pumps due to the risk of the pump catheter perforating the left ventricle wall [2].

This recall, initiated on June 14, 2023, affects over 66,000 devices in the U.S. and is considered the most severe recall status. The health risks associated with the affected Impella pumps include left ventricle perforation, severe adverse health outcomes, and death.

In response to the F.D.A.’s actions, Abiomed has taken specific corrective measures. These include issuing an Urgent Medical Device Correction letter to inform customers of revised warnings and recalling the instructions for use for the Impella Left-Sided Blood Pumps to address perforation risks.

Abiomed has also distributed technical bulletins and product updates aimed at mitigating health risks associated with the Impella pumps.

Despite the FDA’s rejection of Abiomed’s classification of the Impella Connect System as non-device software, the FDA wrote to Abiomed stating their concerns. Through its promotional materials, Abiomed has attempted to demonstrate compliance and address the FDA inspection findings.

Side Effects of Impella Heart Pump

Victims of Impella heart pump failures may experience various side effects that could require significant medical treatment.

These can range from minor complications to major adverse events, including blood flow death, as well as:

  • Bleeding
  • Infection
  • Organ damage
  • Stroke
  • Heart attack
  • Wrongful death

Those severely affected may require substantial medical attention, which often includes costly treatments and procedures. In some cases, victims may experience long-term serious adverse health consequences, including a rare complication, causing them not only physical discomfort but also mental distress, financial hardship, and a decreased quality of life.

The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life-threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream – U.S. Food & Drug Administration

How Do You Qualify for an Impella Heart Pump Lawsuit?

To qualify for an Impella Heart Pump lawsuit, you must have experienced severe injuries or the loss of a loved one due to a defective Abiomed Impella Heart Pump and have had the device implanted between October 10, 2021, and October 10, 2023.

You’ll need to present necessary documentation and evidence of injury or wrongful death. Given the complexity and challenges of this process, seeking assistance from experienced legal professionals is advisable.

The Status Of The Impella Heart Pump Lawsuit Litigation in Colorado

The current status of the Impella heart pump lawsuit litigation in Colorado involves claims of delayed communication of potential problems, resulting in injuries and deaths.

As a defendant in the lawsuits, Abiomed is allegedly being sued for delaying the communication of potential problems with the Impella heart pump to doctors and patients.

Those who received an Impella Heart Pump Device implant between October 10, 2021, and October 10, 2023, may be eligible to seek legal compensation. Obtaining legal advice is vital to understand your rights and explore potential remedies.

Impella Heart Pump Lawsuit Settlement Amounts in Colorado

Information on Impella heart pump lawsuit settlement amounts in Colorado was not provided in the referenced material. However, it’s important to note that each case is unique, and settlement amounts can vary significantly depending on the specific circumstances of each case.

Recoverable damages in defective medical device lawsuits may include:

  • Compensation for medical expenses
  • Lost wages
  • Pain and suffering
  • Loss of consortium in wrongful death cases
  • Other related costs

Filing an Impella Heart Pump Lawsuit in Colorado

If you’ve suffered due to the Impella Heart Pump, you may be considering filing a lawsuit in Colorado. Law firms like Schmidt & Clark, L.L.P., with specialized expertise in medical device lawsuits, including the Impella Heart Pump, can provide legal assistance.

While filing a lawsuit, it’s important to present sufficient evidence and documentation to establish eligibility and demonstrate injury causation. Though the process might seem intricate, expert legal guidance can help you traverse the legal terrain with confidence and efficacy.

Types of Evidence To Present

To hold a manufacturer liable for a defective product, plaintiffs must prove that the product had either a manufacturing, design, or marketing defect. In the case of the Impella Heart Pump, this could involve presenting evidence of specific malfunctions, such as damage to the motor’s impeller blades.

Expert testimonies from medical and scientific experts are often critical in trials involving defective medical devices to help prove fault and causation. In cases of wrongful death, it’s necessary to establish a direct link between the patient’s death and a defect in the device, be it design, manufacturing, or insufficient warnings.

Evidence to support your claim could include medical records, expert testimonies, and proof of financial losses resulting from the injury.

Gathering comprehensive evidence is crucial to building a strong case and maximizing potential compensation, especially when addressing alleged regulatory violations.

Statute of Limitations

The time frame for filing a product liability lawsuit typically starts from the date of surgery, injury, or the discovery of the injury, indicating a limited duration available for lawsuit filing.

The specific duration for the statute of limitations for filing an Impella heart pump lawsuit in Colorado is determined by the state’s laws. While specific details were not provided in the referenced material, it’s always advisable to seek legal advice as soon as possible to ensure that you do not miss the deadline.

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

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If you or someone you care about has been adversely affected by the Impella heart pump, Schmidt & Clark, LLP is here to assist you through these difficult times.

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

We offer free consultations, and our firm operates on a contingency fee basis, meaning we only get paid if you win. Contact us for a comprehensive review of your case.

Reference:

  1. https://www.sts.org/news/fda-announces-class-i-recall-abiomed-impella-instructions-use-left-sided-blood-pumps
  2. https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks

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