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South Carolina Impella Heart Pump Lawsuit (2024 Update)

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Quick Summary

  • The South Carolina Impella heart pump lawsuit represents a critical turning point for patients alleging serious injuries from these medical devices.
  • Suppose you’re seeking information on the background and current status of these legal cases. In that case, this article sheds light on the wrongs claimed and the path to possible redress for South Carolinians affected.
  • If you or a loved one has experienced adverse effects due to the Impella heart pump, Schmidt & Clark, LLP, stands ready to support you. Recognized for our expertise in representing plaintiffs, our firm is committed to helping you secure 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 experienced legal representation tailored to your specific circumstances. Our dedicated team of attorneys specializes in handling complex litigation cases like Impella heart pump lawsuits, offering personalized support every step of the way.

We can assist you by:

  1. Conducting a thorough evaluation of your case to determine eligibility for compensation.
  2. Building a strong legal strategy designed to maximize your chances of success in court.
  3. Advocating fiercely on your behalf to secure fair and just compensation for the damages you’ve suffered due to Impella heart pump-related injuries.

Impella Heart Pump Lawsuit

In the Palmetto State, the Abiomed Impella heart pump, a device designed to offer life-saving blood flow support during heart surgeries, has become the subject of critical legal scrutiny.

Patients across South Carolina, guided by their legal teams, are taking a stand against Abiomed, the manufacturer of the Impella heart pump, due to alleged defects that have led to catastrophic outcomes.

These lawsuits are part of a nationwide effort, as patients from all corners of the country—including the verdant landscapes of South Carolina—are demanding redress for their suffering.

The heart of the matter lies in the harrowing reports of heart-wall tears associated with the use of Impella devices, as revealed by the FDA’s alarming tally of 21 fatalities.

These incidents represent significant concerns that have prompted a closer look at the safety of these devices, particularly for those at higher risk, such as older adults, women, and individuals with pre-existing heart conditions.

The unfortunate outcomes have led to a number of complaints and subsequent legal actions seeking to address the manufacturer’s accountability.

What Is an Impella Heart Pump?

An Impella heart pump is a mechanical device used in cardiology to assist the heart in pumping blood throughout the body. It is typically implanted in patients who are experiencing severe heart failure or undergoing certain cardiac procedures, such as angioplasty or coronary artery bypass surgery.

The Impella heart pump draws blood from the left ventricle of the heart and pumps it into the aorta, thereby increasing blood flow and providing temporary circulatory support.

This device can help stabilize patients during critical situations and allow their hearts to recover function.

Reasons Behind The Recall

The FDA’s involvement has been pivotal, casting a spotlight on Abiomed’s actions or lack thereof. From warning letters addressing inadequate responses to inspections to classifying recalls as the highest-level alert, the FDA has been a driving force in demanding accountability.

Some key actions taken by the FDA include:

  • Addressing inadequate responses to inspections through warning letters.
  • Classifying recalls as the highest-level alert.
  • Bringing unreported complaints and the risk of tearing associated with Impella devices to light.
  • Culminating in the recall of thousands of devices.

Abiomed’s eventual acknowledgment of the issues and issuance of an Urgent Medical Device Correction letter marked a turning point, but questions about the company’s transparency and the adequacy of warnings remain.

In response to the recalls and the risks identified, Abiomed made critical updates to the Impella heart pump’s instructions for use. These updates offer more granular guidance on implantation and repositioning to mitigate the risks, especially for those with specific cardiac and vascular conditions.

Side Effects of Impella Heart Pump

The complications associated with the Impella heart pumps, including impella complications, are far from inconsequential.

According to the Society of Thoracic Surgeons, reports have surfaced of blood clots and blade damage within the motor’s impeller, causing a drastic reduction or complete cessation of blood flow. With 129 serious injuries and 49 deaths linked to these devices, the gravity of the situation is undeniable [1].

Right-sided blood pumps and left-sided blood pumps, including those supporting the left ventricle, have been implicated in these incidents, revealing a disturbing pattern of failure during high-risk surgeries and percutaneous coronary interventions involving blood vessels.

Severe or fatal bleeding is a significant complication associated with Impella support – Shunsuke Saito (M.D., PhD), Cardiovascular Surgeon at the Department of Cardiovascular Surgery, Osaka University

Acute Heart Failure

According to a 2023 PubMed study, acute heart failure is a beast that the Impella RP with SmartAssist was engineered to tame. Designed for short-term right heart support, this device showed promise, with clinical studies like RECOVER RIGHT indicating a survival rate of 73%. However, when acute myocardial infarction leads to cardiogenic shock, the stakes are high [2].

The National Cardiogenic Shock Initiative Study underscores the importance of timely mechanical circulatory support to improve patient outcomes. Yet, for those who suffered severe injuries or blood flow death, the question remains: was the intervention early and effective enough?

Heart Wall Perforations

When it comes to heart wall perforations, the Impella heart pumps have been under intense scrutiny. The FDA’s numerous recalls, including four Class I recalls in 2023, point to a dire issue: the risk of the pump catheter slicing through the heart wall, leading to life-threatening conditions or even death.

Heart surgery, already fraught with risks, becomes infinitely more difficult when factoring in the potential for heart wall tears.

How Do You Qualify for an Impella Heart Pump Lawsuit?

To qualify for an Impella heart pump lawsuit, you must have experienced serious adverse effects, such as heart wall perforations, blood clots, or device failure, after having an Impella device implanted.

It is also essential that you or your legal representative can demonstrate that these complications directly resulted from the use of the Impella heart pump. Furthermore, your claim must be filed within the statute of limitations, which varies by state.

The Status Of The Impella Heart Pump Lawsuit Litigation in South Carolina

For those who have experienced complications with the Impella heart pump, the path to justice involves navigating the complexities of the legal system.

Victims and their families can pursue legal action, seeking compensation for the severe injuries or wrongful death caused by these medical devices. The process can be daunting, but it is a necessary step towards holding manufacturers accountable and ensuring such harm does not occur to future patients.

A law firm that specializes in these cases can offer a free consultation, becoming a beacon of hope for those seeking to reclaim their lives from the shadow of medical device harm.

Impella Heart Pump Lawsuit Settlement Amounts in South Carolina

In the quest for justice, the aim is not only to highlight the wrong but to alleviate the burden it has caused. South Carolina victims of Impella heart pump complications have the right to seek compensation that encompasses the full spectrum of their suffering. This can translate into coverage for medical bills, compensation for lost wages, and monetary acknowledgment for the pain endured.

For those who mourn the loss of a loved one, wrongful death compensation offers a small measure of solace in the face of irreplaceable loss.

Filing an Impella Heart Pump Lawsuit in South Carolina

Filing an Impella heart pump lawsuit in South Carolina involves navigating complex legal processes to seek justice and compensation for those affected by the device. Plaintiffs will need to gather medical records, expert testimonies, and evidence of the device’s failure to establish a strong case. The goal is to secure financial redress and hold the manufacturer accountable for the alleged defects.

Types of Evidence To Present

Presenting compelling evidence to substantiate your claim is crucial when pursuing an Impella heart pump lawsuit in South Carolina.

Types of evidence that can be instrumental include:

  1. Medical Records: These documents are foundational to any medical-related legal case. They provide a detailed account of your health history, the implantation of the Impella device, any complications that arose, and the treatments that followed.
  2. Expert Testimony: Medical experts can offer insights into how the device may have malfunctioned and the consequent impact on your health. Their testimony can help explain complex medical issues in a way that is understandable to the court.
  3. Device Failure Reports: Any records or correspondence that point to the device’s failure or recalls can support claims of its inadequacy or danger.
  4. Personal Testimony: The personal experiences of the plaintiff, detailing the pain and suffering endured, can be a powerful component of your case.
  5. Witness Statements: Statements from family, friends, or caregivers who have observed the plaintiff’s struggles can corroborate the extent of the impact on the plaintiff’s life.
  6. Financial Records: Documentation of financial losses due to medical expenses, lost wages, and other costs associated with the complications from the Impella device.
  7. Correspondence with Healthcare Providers: Any communication with doctors, nurses, or other healthcare professionals regarding the Impella device and the issues it caused.
  8. Photographic Evidence: Photos of injuries or complications can serve as visual proof of the severity of the condition.

Collecting and presenting this evidence requires meticulous attention to detail and an understanding of legal procedures. A skilled attorney can assist in assembling and articulating these elements to build a compelling case for your Impella heart pump lawsuit.

What Is the Statute of Limitations for the Impella Heart Pump Lawsuit In South Carolina?

The statute of limitations for the Impella heart pump lawsuit in South Carolina is three years from the date of injury. This time frame is critical for anyone seeking to file a claim, as South Carolina law generally allows individuals up to three years to initiate legal proceedings for personal injury cases.

It’s imperative to be aware of this limitation, as failure to file within this period may result in the loss of the right to compensation.

Related Articles:

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

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At Schmidt & Clark, LLP we stand beside you in these difficult times. Should you or someone close to you have endured complications from the Impella heart pump, we encourage you to get in touch.

Our seasoned legal team specializes in such matters and will navigate you through every step of the legal process. We’re committed to providing clear insights into your legal options and determining your qualification for filing a lawsuit regarding Impella heart pump complications.

We offer free consultations, and our fee structure is contingent on obtaining a favorable outcome for you. You can trust our commitment to offering you the same attention and care that we would extend to our family members. Contact us for a comprehensive review of your situation.

Reference:

  1. https://www.sts.org/news/fda-announces-class-i-recall-abiomed-impella-instructions-use-left-sided-blood-pumps
  2. https://pubmed.ncbi.nlm.nih.gov/26681124/

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