Pennsylvania Impella Heart Pump Lawsuit: Risks and Recalls in 2024

Quick Summary

• If you or someone close to you has been impacted by the Pennsylvania Impella heart pump lawsuit regarding the Impella heart pump device, you might consider taking legal action in Pennsylvania.
• This article provides an overview of the ongoing Pennsylvania Impella heart pump lawsuit. It covers the serious injuries and deaths associated with the device, the compensation claims, and the recent FDA recalls that have influenced the litigation in Pennsylvania.
• If you or someone you’re acquainted with has experienced adverse effects from the Impella heart pump, Schmidt & Clark, LLP stands ready to support you. Known for our expertise in representing plaintiffs, our primary goal is to help 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 serving as a beacon of hope for those affected by medical device issues. More than just legal services, the firm provides a lifeline for victims to reclaim their lives. The firm understands that the complex maze of legal proceedings can be overwhelming, especially when coping with personal suffering or the loss of a loved one.

S&C’s dedicated team offers:

• Free case evaluations.
• Guiding you through every step of the legal process.
• We’re committed to helping you seek compensation for damages, ensuring you don’t have to face this battle alone.

Impella Heart Pump Lawsuit

In Pennsylvania, concerns have emerged regarding the Impella heart pump, a device intended to aid cardiac function. Individuals who have experienced serious complications associated with the device have initiated legal actions.

These cases involve patients who have suffered significant injuries, families who have faced the loss of a loved one, or those who have observed serious injuries related to the use of the Abiomed Impella heart pump.

These lawsuits aren’t just about seeking compensation; they’re about seeking justice. They’re about holding Abiomed accountable for the damages caused by their product. People harmed by an Impella Heart Pump don’t have to fight this battle alone – law firms like S&C are standing by to lend their expertise and support.

What Is an Impella Heart Pump?

An Impella heart pump is a mechanical savior for the heart, particularly the ventricles, which are tasked with pumping blood throughout the body. This device becomes crucial in dire situations like acute heart failure, cardiogenic shock, and during percutaneous coronary interventions (PCI) – complex procedures that may involve the placement of stents or balloons to open up blood vessels.

The beauty of the Impella heart pump lies in its design. It’s a percutaneous ventricular assist device, meaning it can be inserted without the need for heart surgery, typically through an incision in the leg to access the femoral artery. Once in place, impella blood pump devices assist the left ventricle in maintaining adequate blood flow, thus providing support during medical procedures, particularly PCI.

The device also relays information to an external console, allowing healthcare professionals to monitor the heart’s function and the volume of blood being pumped.

Reasons Behind The Recall

According to the FDA’s classification of the recall as a Class I, a high risk of serious injury or death associated with these pumps. Over 66,000 Impella blood pump devices were recalled across the United States, marking a significant chapter in the saga of this heart pump [1].

It’s not every day that the FDA initiates a Class I recall – the most serious type of recall due to potential risks of serious injuries or deaths.

But that’s exactly what happened with the Abiomed Impella heart pump on June 14, 2023. This recall affected over 7895 units and included multiple Impella models distributed between October 10, 2021, and October 10, 2023.

Serious injuries and 49 fatalities linked to the Impella heart pumps were reported, with 21 cases detailing heart-wall tears leading directly to patient deaths. Severe complications like left ventricle perforation or free wall rupture have been highlighted by the FDA’s alert regarding a range of recalled Impella Heart Pump models.

This led to a comprehensive inspection at Abiomed’s headquarters, culminating in a warning letter in September and alerts advising special care during the insertion of the Impella pump catheter, especially for high-risk patients or those undergoing active CPR.

The recall of Impella Left Sided Blood Pumps was initiated following the discovery that the pump catheter could potentially perforate the left ventricle heart wall. This issue was linked to serious injuries, and 49 reported deaths, leading to a recall of the instructions for 66,390 Impella left-side heart pumps distributed between October 10, 2021, and October 10, 2023.

Side Effects of Impella Heart Pump

The Impella heart pumps have been linked to several complications, including heart tears, blood clots, and anemia, which can lead to Impella heart pump injuries.

Patients have reported an increased risk of severe conditions like heart perforation, stroke, and organ failure following the use of Impella heart pumps. The complications associated with the Abiomed Impella Heart Pump Device, such as ventricular wall perforation and lack of blood flow, have been tied to multiple fatalities.

Lawsuits have alleged that Abiomed was aware of the heart wall tear risk linked to the use of their Impella heart pumps since at least 2018.

The recall was prompted by risks such as the pump catheter perforating the left ventricle, leading to severe medical conditions. These malfunctions have left a trail of victims in Pennsylvania, many of whom have pursued compensation for serious injuries.

Stroke is one of the most common and serious complications of many MCSs, and Impella is no exception – Shunsuke Saito (M.D., PhD), Cardiovascular Surgeon at the Department of Cardiovascular Surgery, Osaka University

How Do You Qualify for an Impella Heart Pump Lawsuit?

To qualify for an Impella Heart Pump lawsuit, you must have suffered harm due to the device. Plaintiffs in Pennsylvania have initiated legal actions against Abiomed, encompassing personal injury and wrongful death claims related to the Impella heart pump, grounded in product liability law.

The basis of product liability claims includes serious adverse health consequences such as left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and blood flow death.

These issues can ultimately lead to death from using the affected Impella pumps. Negligence claims in the Impella heart pump lawsuits allege that Abiomed failed to properly design, manufacture, or warn about the potential risks associated with their device.

The Status Of The Impella Heart Pump Lawsuit Litigation in Pennsylvania

The history of the Impella Heart Pump lawsuits is dotted with notable cases that have shaped the course of this legal battle. The FDA issued a Class I recall for the Impella heart pumps after findings linked the device to 49 deaths and multiple patient injuries. More than 66,000 Impella devices were recalled following an urgent medical correction letter issued by the FDA.

These cases paint a stark picture of the risks associated with the Impella heart pumps. Yet, despite the Class I recall, the Impella heart pumps remain on the market but with updated instructions for use. Abiomed, the manufacturer of Impella pumps, reported working on improvements after acknowledging heart-wall tears as a rare complication. However, for many victims, these improvements came too late.

As of the latest updates, the Pennsylvania litigation landscape for the Impella heart pump lawsuits remains active and dynamic. The legal proceedings have seen a steady influx of new cases as more individuals come forward with claims of injuries and fatalities linked to the device.

The courts are currently managing the pre-trial phases, which include discovery and motions that will shape the trajectory of the lawsuits.

Recent developments have also seen the consolidation of several cases, which may streamline the process and potentially lead to more efficient resolutions. However, the complexity of the claims and the serious nature of the allegations suggest that the litigation could continue for some time as both sides prepare for a possible trial or settlement negotiations.

Impella Heart Pump Lawsuit Settlement Amounts in Pennsylvania

As victims in Pennsylvania seek justice, many are inevitably wondering about the potential settlement amounts. While it’s impossible to predict the exact figures, it’s clear that the stakes are high in these lawsuits. With each case representing a story of personal suffering and loss, the financial implications are just one piece of a much larger puzzle.

In Pennsylvania, victims can seek compensation for damages associated with medical device lawsuits. These damages include compensation for medical costs, lost wages, and potentially other damages such as pain and suffering.

Furthermore, plaintiffs may also be entitled to compensation for future medical treatment expenses, lost earning capacity, and emotional distress resulting from defective medical devices.

Individuals who have experienced complications such as heart tears, anemia, and blood clots after receiving an Impella Heart Pump may qualify for financial compensation. However, each case is unique, and the exact compensation will depend on the specific circumstances of each case.

Filing an Impella Heart Pump Lawsuit in Pennsylvania

For those considering legal action, the first step is undergoing a case evaluation with a law firm to determine eligibility for compensation.

From there, you can decide whether to proceed with the class action lawsuit. It’s a journey that can be daunting, but with the right legal team by your side, it’s a fight you don’t have to face alone.

Types of Evidence To Present

If you decide to proceed with a lawsuit, it’s essential to gather the right evidence.

This includes:

• Documentation of the failure or damage of the pump
• Medical records showing injuries or death due to the device
• Evidence of the necessity of the device during surgery
• In some cases, claimants needed to undergo open-heart surgery to remove the Impella device or retrieve broken pieces, which can serve as critical evidence in a lawsuit.

Other forms of evidence include medical records, such as reports, documents, and notes made by doctors and nurses, which serve as a primary form of evidence to establish a timeline of events and care related to the incident.

Hospital records, including admissions, discharge forms, medication lists, lab results, and operative reports, are crucial for substantiating claims in a medical malpractice case.

Expert witness testimony from healthcare professionals with relevant expertise, statements from witnesses present at the time of injury, the patient’s testimony, photographs and videos capturing the injuries sustained, and information about past malpractice claims against the same provider can all be leveraged to build a strong case.

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

The statute of limitations for the Impella Heart Pump lawsuit in Pennsylvania is 2 years from the date of the injury. If the injury was not immediately apparent, the statute of limitations may begin from the date the injury was discovered.

Related Articles:

• South Carolina Impella Heart Pump Lawsuit
• Virginia Impella Heart Pump Lawsuit Attorney
• Illinois Impella Heart Pump Lawsuit

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

Get Your Free Consultation From Pennsylvania Our Lawyers

At Schmidt & Clark, LLP we stand by your side during difficult times. Should you or someone you care about have experienced complications from the Impella heart pump, we encourage you to get in touch with us. Our seasoned team is well-versed in managing such claims and will navigate you through the complexities of the legal system.

We’re committed to providing clear insights into your legal options and determining your qualifications for filing a lawsuit related to the Impella heart pump. Our consultations come at no cost, and our fees are contingent upon securing a victory in your case.

References:

1. https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks