Florida Impella Heart Pump Lawsuit (Latest Updates)

Quick Summary

• If you’re dealing with complications from the Impella Heart Pump and are contemplating legal action in Florida, rest assured that you are not alone.
• This article dives into the specifics of the Florida Impella heart pump lawsuit, including the reasons for the lawsuits, what is at stake for plaintiffs, and what steps you can take if affected. We outline the crucial information you need to navigate this complex legal scenario.
• If you or someone you care about has experienced complications from the Impella heart pump, Schmidt & Clark, LLP, stands ready to support you. Known for our expertise in advocating for plaintiffs, our primary goal is to help you achieve 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 leveraging their extensive experience in product liability lawsuits, particularly in cases involving faulty medical devices like the Impella Heart Pump.

The firm commits to securing justice for victims by:

• Handling complex cases for optimal compensation
• Streamlining the legal journey
• Providing free case evaluations and legal strategy advice

Impella Heart Pump Lawsuit

The Abiomed Impella heart pump, also known as Impella heart pumps, is the subject of a series of legal challenges in Florida. The lawsuits primarily involve allegations of product liability and negligence, with claims arising from device malfunctions and complications.

The heart of the issue lies in the manufacturer’s alleged failure to warn healthcare providers about potential risks associated with the device.

The Impella heart pump lawsuits cite numerous Impella heart pump complications, including:

• Device failure
• Instances leading to serious injuries and fatalities
• Malfunctioning during medical procedures, posing life-threatening risks
• Potential to fracture during transcatheter aortic valve replacement procedures, such as heart valve replacement surgery

These complications highlight the need for further investigation and potential action to prevent serious adverse health consequences.

It is important to be aware of these risks and to consult with a medical professional if you have any concerns about the safety of your medical device.

Abiomed is facing accusations of failing to adequately warn healthcare providers about the risks of potential malfunctions with the Impella heart pump.

Plaintiffs assert they were not sufficiently informed about the risks involved with using the Impella device, citing a lack of comprehensive warnings and instructions with the product’s labeling.

The concerns include specific risks such as reduced blood flow, blood flow death, purge fluid leakage, or the device coming to a stop due to system damage.

What Is an Impella Heart Pump?

An Impella heart pump is a percutaneous ventricular assist device that supports blood flow for patients with coronary artery disease, those recovering from cardiogenic shock, or individuals awaiting a heart transplant.

Unlike traditional heart pumps, Impella pumps are inserted via the femoral artery in the leg, eliminating the need for open-heart surgery. The Impella heart pump device functions by replacing the role of the left ventricle, aiding blood circulation throughout the body, especially during medical procedures like percutaneous coronary interventions.

While Impella pumps are typically covered by medical insurance, either partially or fully, the cost can vary depending on the patient’s coverage and hospital.

However, despite its benefits, the use of an Impella pump comes with potential risks, including:

• Life-threatening bleeding
• Damage to blood vessels or heart
• Organ failure
• Infection
• Arrhythmias

Reasons Behind The Recall

According to the FDA, in July 2023, the agency issued a Class I recall, the most serious type of recall, for the Abiomed Impella heart pumps due to risks that could result in severe harm or death to the patient [1].

The FDA documented the following incidents associated with the use of the Impella blood pump devices:

• At least 129 serious injuries
• 49 deaths
• 30 complaints
• 26 additional injuries
• 4 additional deaths

The recall affected specific models of Impella heart pumps, including the Impella 2.5, CP, CP with SmartAssist, 5.0, 5.5 with SmartAssist, and LD Intravascular Micro Axial Blood Pumps. The issues included the risk of the device breaking during procedures or leakage.

In response, Abiomed issued an Urgent Medical Device Correction letter with updated instructions and new warnings. The FDA also warned Abiomed in October 2023 for marketing the Impella Connect system without proper premarket approval.

Side Effects of Impella Heart Pump

Potential side effects of the Impella heart pump devices include:

• Limb ischemia, with reported incidence ranging from 0.07% to 10%
• Significant bleeding, with reported incidences ranging from 0.05% to 54%
• Cerebrovascular accidents, including hemorrhagic and ischemic strokes, with incidences varying from 2.4% to 6.3%

In addition to these complications, the Impella device has been associated with:

• Hemolysis, which could lead to renal failure, with incidences reported at 7-8%
• Infections at the access site and sepsis, especially if the support duration is extended
• Induction of arrhythmias due to the presence of the Impella pump within the left ventricle.

One of the most serious risks associated with Impella Left Sided Blood Pumps is the catheter puncturing the wall of the left ventricle during operations, potentially causing heart wall tears.

According to the U.S. Department of Health and Human Services 2023 study, this can lead to serious health consequences, including [2]:

• Left ventricle perforation or free wall rupture
• Hypertension
• Insufficient blood flow
• Mortality

In fact, following the recall, there were reports of 129 cases of serious injury, including 49 fatalities linked to complications from the Impella pumps.

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, you must demonstrate that you have suffered injuries due to the device, and these claims often involve allegations of product liability.

Additionally, plaintiffs must provide evidence of negligence, asserting that Abiomed’s allegedly defective design or manufacturing defects of the Impella heart pump were directly responsible for their injuries.

Additionally, plaintiffs assert that Abiomed failed to warn about the risk of heart perforation, forming the basis for ‘failure to warn’ legal claims.

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

The Status Of The Impella Heart Pump Lawsuit Litigation in Florida

As of March 2024, the status of the Impella Heart Pump lawsuit litigation in Florida remains in the preliminary stages. The litigation is still in the discovery phase, where parties are collecting evidence such as depositions, document requests, and interrogatories.

Despite the lack of new developments, lawyers are still accepting cases, indicating an active pursuit of litigation.

To date, over 100 lawsuits have been filed in Florida against Abiomed. The number of lawsuits has also significantly increased over recent months, connected to emerging evidence regarding complications with the Impella heart pump.

Recently, an additional 20 cases have been filed, which represents a significant increase in the litigation against Abiomed.

Despite the rising number of lawsuits, as of March 2024, there have been no publicly reported settlements, verdicts, or major procedural developments in the Impella heart pump litigation. However, attorneys for the plaintiffs continue to accept and evaluate new cases related to the Impella heart pump.

Patients and families are engaging experts specializing in product liability and wrongful death for their claims.

Impella Heart Pump Lawsuit Settlement Amounts in Florida

If you’re considering filing an Impella heart pump lawsuit, it’s important to understand the potential compensation.

Victims and their families involved in Florida Impella heart pump lawsuits may be eligible for compensation that includes:

• Coverage for medical expenses
• Lost wages due to inability to work
• Pain and suffering
• Inconvenience
• Loss of enjoyment of life
• Mental anguish

Compensation for medical expenses incurred due to injuries or complications from the Impella heart pump forms a significant part of the settlement. These medical expenses include costs for surgeries, such as removing and replacing defective hardware and associated medical treatments.

This compensation aims to cover the financial losses and suffering experienced by victims of the Impella heart pump.

Filing an Impella Heart Pump Lawsuit in Florida

When it comes to filing an Impella heart pump lawsuit in Florida, having an experienced attorney is crucial. They not only manage the legal process and negotiate settlements but also play a key role in gathering evidence by collecting medical records that support the claim.

Types of Evidence To Present

Evidence is crucial in an Impella heart pump lawsuit. Medical records provide detailed information about the device’s use and any subsequent injuries or complications. Witness statements, such as those from healthcare providers or other patients, offer valuable insights.

Gathering additional documentation, such as FDA safety alerts or reports on the Impella device, can also help support the lawsuit’s claim.

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

The statute of limitations for the Impella heart pump lawsuit in Florida is four years from the date of the injury or from when the injury should have reasonably been discovered.

Potential plaintiffs need to be aware of this time frame to avoid having their lawsuit dismissed for late filing.

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

Get Your Free Consultation From Florida Our Lawyers

At Schmidt & Clark, LLP we understand the complexities you face if you’ve been affected by the Impella heart pump. Our seasoned legal team is ready to assist you or your family members through this difficult period. We specialize in such medical device cases and are committed to navigating you through the legal maze.

We will elucidate your legal entitlements and determine your qualifications for filing a lawsuit. Our initial consultations are offered at no cost, and our fee structure is contingent on winning your case for you.

Don’t hesitate to contact us for an in-depth assessment of your case.

Reference:

1. https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks
2. https://pubmed.ncbi.nlm.nih.gov/31279538/#full-view-affiliation-1