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Tennessee Impella Heart Pump Lawsuit (Latest 2024 Update)

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Quick Summary

  • The intricacies of the Tennessee Impella Heart Pump lawsuit, encompassing both patient risks and legal actions, are the focus of this discussion. This case has brought to light significant concerns regarding the safety and efficacy of the device, prompting a series of legal challenges and calls for accountability.
  • This article aims to demystify the complexities of the case, shedding light on the device’s purported risks and the ongoing legal proceedings.
  • If you or someone close to you has experienced harm from the Impella heart pump, Schmidt & Clark LLP stands ready to support you. Known for our expertise in representing plaintiffs, we are committed to helping you secure the justice and recompense you are entitled to.

How S&C Can Help With Your Claim?

S&C can help with your claim by offering expert legal representation in medical device recall lawsuits, particularly for cases like the Impella Heart Pump recall lawsuit. Drawing on a wealth of experience in advocating for plaintiffs against large medical corporations, S&C stands as a pillar of support for patients impacted by recalled cardiac devices.

The firm is unwavering in its dedication to providing comprehensive legal counsel, meticulously evaluating each case for potential compensation, and guiding clients through the intricacies of claims for additional surgeries necessitated by device malfunctions.

Here’s how we can assist:

  • We offer personalized legal advice tailored to the specifics of your case
  • Our team works tirelessly to evaluate your case for potential compensation opportunities
  • We provide step-by-step assistance in filing claims related to additional surgeries due to device malfunctions

Impella Heart Pump Lawsuit

The Impella Heart Pump, manufactured by Abiomed, has become the subject of numerous lawsuits in Tennessee due to its alleged defects and the health risks it poses. Patients claim that the manufacturer was negligent, waiting too long to alert doctors and patients about potential problems that could lead to injury and even death.

Over the past year, Tennessee courts have witnessed an unprecedented surge in lawsuits filed against Abiomed, the manufacturer of the Impella Heart Pump. These lawsuits have revealed patterns of device failure and serious health risks, leading to some cases being consolidated as multi-district litigation.

According to the Society of Thoracic Surgeons, the FDA has linked the use of Impella CP heart pump to 49 deaths and 129 injuries related to heart wall punctures, bringing the device’s safety into question [1].

At the heart of these lawsuits are allegations of negligence against Abiomed. The manufacturer stands accused of delaying alerts about potential problems with the device, specifically, the risk of heart wall perforation.

This delay in reporting to the FDA resulted in a lag in disseminating warnings to healthcare institutions and professionals, potentially putting patients at further risk.

Lawsuits suggest that the Impella Heart Pump is defective, leading to severe injuries and fatalities, with at least 30 complaints, 26 injuries, and four deaths reported.

What Is an Impella Heart Pump?

An Impella Heart Pump is a left-ventricular device designed to aid heart function during surgery or in patients with severe cardiac conditions. Known as the Impella CP, this minimally invasive heart pump is inserted via a small incision in the leg to reach the femoral artery, which then allows access to the heart’s left ventricle.

By avoiding the need for open-heart surgery, the pump catheter supports the heart’s ventricles – the main blood-pumping chambers – thereby maintaining circulation throughout the body.

However, the device is subject to damage that can lead to reduced blood flow or complete stoppage, particularly if the pump’s motor housing contacts stents from a transcatheter aortic valve replacement. The risk associated with the use of an Impella Heart Pump includes severe bleeding, damage to blood vessels or the heart, organ failure, infection, and arrhythmias.

Reasons Behind The Recall

According to the FDA, the agency’s Class 1 recall for the Impella Heart Pump is indicative of serious concerns, such as heart wall perforations, revolving around this device [2].

This recall, which directly affected over 7895 units of the device, was due to the risks involving severe injuries and complications.

The FDA’s call for changes in the device’s instruction manual did not extend to its removal from the market despite the identified risks. Abiomed was issued a warning letter following an FDA inspection, which uncovered a bulletin addressing the risks of heart tearing.

In light of the mounting concerns over the safety of the device, the FDA issued its highest-level alert, a Class I recall, for the Abiomed Impella Heart Pump Device. This was due to the risks involving severe injuries and complications, including ventricular wall perforation and multiple deaths.

These recalls and FDA findings have greatly influenced legal action in Tennessee, validating claims of inadequate risk disclosure and dangerous defects.

Side Effects of Impella Heart Pump

While the Impella Heart Pump serves a crucial function for those with severe heart conditions, its use is not without risks.

Individuals who are older adults, women, or have pre-existing heart conditions are at a higher risk of experiencing life-threatening conditions, including heart wall tears.

These groups should be especially cautious when considering treatments with potential tearing risk. This surgical emergency often has a significantly low chance of survival, making the device’s dangers all too real.

The Impella device works by:

  • Drawing blood from the left ventricular cavity
  • Expelling it into the systemic circulation
  • Aiding in unloading the left ventricle
  • Potentially improving cardiac output

In cases of acute myocardial infarction complicated by acute heart failure and cardiogenic shock, the Impella device is used to enhance the safety of high-risk percutaneous coronary interventions.

One of the most serious complications associated with the Impella Heart Pump is left ventricle perforation. This severe complication can lead to serious injury or death.

For those who have suffered from heart wall tears, sometimes referred to as heart tears, caused by the device, the health consequences have often been severe, sometimes resulting in blood flow death, akin to a heart attack.

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 have been implanted with the device and then suffered from complications, injuries, or adverse events as a result.

A claim against the manufacturer, distributor, or healthcare provider can include product liability, medical malpractice, or lack of appropriate warnings or instructions.

The Status Of The Impella Heart Pump Lawsuit Litigation in Tennessee

For those following the Impella Heart Pump lawsuits, you might be curious about the current status of litigation in Tennessee. The FDA has issued a Class I recall for the device due to increased risks of severe complications and associations with multiple deaths.

Presently, litigation is active, and individuals who were implanted with the device between October 10, 2021, and October 10, 2023, may be entitled to compensation.

Impella Heart Pump Lawsuit Settlement Amounts in Tennessee

To better understand potential settlement amounts, let’s examine historical settlements in similar medical device cases. One such case is the Vioxx litigation, which involved claims against Merck for the drug’s alleged cardiovascular risks.

The first Vioxx lawsuit case to be tried ended with a $253 million award to the plaintiff, which was later reduced and overturned on appeal due to insufficient evidence of causation. Despite early victories, Merck eventually settled the Vioxx lawsuits with a compensation fund of $4.85 billion without admitting fault.

These cases shed light on the potential high value of claims involving medical devices like the Impella Heart Pump and other Impella devices.

If you’re considering filing a lawsuit, you might be wondering about potential settlement amounts. In Impella Heart Pump lawsuits in Tennessee, the amount of compensation one might receive depends on various factors, such as the severity of the injury, the cost of medical care, and the impact on the individual’s future earning capacity.

In defective medical device claims like those involving the Impella Heart Pump, plaintiffs may seek compensation for the following damages:

  • Economic damages include compensation for past and anticipated medical bills and lost wages if the injury prevents a patient from working.
  • Non-economic damages: compensation for the pain and suffering caused by defective medical devices.
  • Punitive damages: in instances of egregious misconduct, plaintiffs can seek punitive damages, which are intended to punish the defendant and deter future misconduct.

Filing an Impella Heart Pump Lawsuit in Tennessee

If you’re considering filing a lawsuit related to the Impella Heart Pump, there are several factors you need to consider. First, you must have incurred severe injuries, or a loved one must have suffered fatal consequences as a result of using the device.

Specific grounds for a lawsuit can include complications from heart valve replacement surgery involving the device and injuries such as brain damage caused by inadequate blood flow.

Types of Evidence To Present

When filing a lawsuit, comprehensive medical documentation is essential. This forms the backbone of your evidence and serves to substantiate your claims.

Key elements of effective medical documentation include:

  • Detailed notes from physicians
  • Diagnostic reports
  • Treatment plans
  • Progress notes

Such documentation can support legal arguments in personal injury cases; thus, documenting them meticulously is crucial.

Another key aspect of filing a lawsuit is working with expert witnesses. Expert witnesses in medical device lawsuits provide necessary testimony to:

  • Inform the judge and jury on the standard of care
  • Establish if negligence occurred
  • Review medical records to substantiate claims of device-related injuries

Their testimony, which is part of the evidence exchanged during the discovery phase of a lawsuit, can include medical records and other relevant information.

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

The statute of limitations for the Impella Heart Pump lawsuit in Tennessee is two years. You are required to initiate legal proceedings within a specific time frame after the injury occurs or after the discovery of the product defect.

Consulting with a legal expert is essential to comprehending this time frame and guaranteeing that your lawsuit is filed within the statutory limits.

Related Articles:

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

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If you or someone you care for has been adversely affected by the Impella heart pump, Schmidt & Clark, LLP stands ready to assist you through these difficult times. Our team is well-versed in managing cases like these and will navigate you through every step of the legal process.

We’re committed to providing clear insights about your legal options and determining your eligibility for a lawsuit regarding device complications.

We offer free consultations, and our fees are contingent upon securing a victory for you. Contact us for a comprehensive review of your situation.



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