Maryland Impella Heart Pump Lawsuit (2024 Update)

Quick Summary

• If you or a loved one has been affected by complications from an Impella heart pump in Maryland, it is crucial to stay informed about the ongoing lawsuits.
• This article breaks down what you need to know about the ongoing Impella heart pump lawsuits, who qualifies to file a lawsuit, the potential compensation available, and the steps to take. Stay informed and understand your legal options regarding the Maryland Impella heart pump lawsuit.
• If you or someone you know has been affected by complications from the Impella heart pump, Schmidt & Clark, LLP, is here to assist you. Renowned for our proficiency in plaintiff representation, our main objective is to ensure you obtain the justice and compensation you rightfully deserve.

How S&C Can Help With Your Claim?

S&C can help your claim by providing expert legal advice and representation throughout the entire process. We are here to support you every step of the way, ensuring that your rights are protected and your voice is heard.

Here’s how we can assist:

• Thorough Investigation: We’ll meticulously review your medical records and the circumstances surrounding the use of the Impella heart pump to build a strong case.
• Evidence Gathering: Our team will collect all necessary documentation, including expert testimonies, to support your claim.
• Relentless Advocacy: We will represent you in all legal proceedings, negotiate with the other parties, and fight for the highest possible compensation.

With a deep understanding of the complexities of medical device litigation, we are committed to holding responsible parties accountable and delivering justice for our clients.

Impella Heart Pump Lawsuit

The Impella Heart Pump, while a critical device for patients with severe heart conditions, has unfortunately been at the center of serious legal scrutiny. When the technology falls short, patients face life-threatening consequences, leading to a wave of lawsuits.

These legal actions highlight the grave impact of the device’s malfunction, prompting a reevaluation of its safety and reliability in the medical community.

What Is an Impella Heart Pump?

An Impella Heart Pump is a sophisticated device engineered by Abiomed to assist the heart’s left ventricle, facilitating the circulation of blood to the rest of the body when the heart is unable to perform effectively on its own.

Despite its crucial role in providing temporary circulatory support, the device is not without its complications, which will be examined further in the context of left-sided blood pumps.

Impella heart pumps are a significant advancement in medical technology. They are designed to assist patients with severe heart conditions by maintaining blood flow. This device is among the various Impella blood pump devices that play a critical role in supporting the heart’s left ventricle.

Reasons Behind The Recall

According to the FDA’s notice, the agency has classified the Impella recalls as Class I, reflecting the high risk of serious injury or death. These recalls were issued following reports of the pump catheter severing the left ventricle wall, a complication with potentially fatal outcomes [1].

In 2023, the FDA even issued a warning letter to Abiomed, citing delays in recalls and reporting issues related to the Impella 5.5 pumps.

The recalls span across several Impella models, such as the Impella 2.5, Impella CP, Impella 5.5 with Smartassist, and others, all of which have been associated with at least 129 serious injuries and 49 deaths.

According to a 2023 study by the Washington University School of Medicine, using the Impella pump open heart surgery could lead to a 24% higher risk of death and a 34% increased risk of stroke compared to other methods like balloon pumps [2].

With no improved outcomes in any category to its credit, the Impella pump’s safety profile has become a serious cause for concern, especially in light of the higher costs and adverse outcomes observed in hospitals frequently using the device.

Side Effects of Impella Heart Pump

Certain populations, such as older adults, women, and those with pre-existing heart conditions, find themselves particularly at risk. Even with updated instructions and awareness of the pump risks, the device remains on the market, and physicians continue to use it.

The serious adverse health consequences associated with the Impella heart pump include a range of serious conditions, such as:

• Hemorrhage or bleeding complications
• Hemolysis, which is the destruction of red blood cells
• Perforation of the heart or blood vessels
• Thrombosis, leading to blood clots
• Stroke
• Limb ischemia, which is a lack of blood flow to the limbs
• Infection at the site of the device

According to MDDI, in July 2023 alone, four fatalities were directly connected to the Abiomed Impella heart pump, with an additional 30 complaints and 26 injuries making headlines. The device’s potential to cause hypertension and inadequate blood flow due to malfunction is alarming [3].

Left ventricle perforation, hypertension, lack of blood flow, and death are among the severe risks associated with Impella devices.

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 (M.D.), 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 in Maryland, you must have suffered severe injuries or endured the tragic loss of a loved one due to a device defect. Those who have undergone heart valve replacement surgery and subsequently experienced pump failure or damage could be eligible to file a claim.

Brain damage or other serious injuries resulting from reduced blood flow could also qualify an individual to file a lawsuit. Wrongful blood flow death claims demand a direct causal link between the defect and the patient’s untimely death. At the same time, the presence of manufacturing issues or design flaws within the heart pump, such as heart wall tears, further determines eligibility.

The Status Of The Impella Heart Pump Lawsuit Litigation in Maryland

Families and patients have taken a stand, initiating lawsuits against Abiomed for the wrongful deaths and injuries caused by this device. These legal battles are not for the faint of heart. With litigation still in its infancy and no trials scheduled as of May 2024, Maryland’s courts are bracing for what may become a lengthy legal fight.

Impella heart pump recalls carry significant implications. Over 66,000 devices have been recalled in the U.S. due to the risk of pump catheter perforation.

Impella Heart Pump Lawsuit Settlement Amounts in Maryland

Victims of Impella heart pump complications may find solace in compensation, though settlement amounts can vary based on several factors. Notably, in March 2018, Abiomed agreed to a settlement of $3.1 million following allegations that the company had provided expensive meals to physicians as an inducement to purchase its pumps.

This incident underscores the complex landscape within which these medical devices operate and the various considerations that can influence settlement outcomes.

Other forms of compensation can include:

• Recovery of medical expenses, ensuring that the financial burden of hospital stays, surgeries, and ongoing treatments does not add to the trauma suffered.
• Recompense for the wages they’ve lost due to recovery.
• Potential future income loss.

Beyond the tangible costs, compensation for pain and suffering acknowledges the physical and emotional toll these injuries have taken. Emotional distress, an often-overlooked consequence, can also be compensated for the psychological impact of such a harrowing experience.

Filing an Impella Heart Pump Lawsuit in Maryland

Initiating a lawsuit in Maryland starts with the following steps:

1. Discuss your case details with a medical malpractice intake specialist.
2. If the preliminary assessment suggests potential negligence, consult with a medical malpractice lawyer experienced in lawsuits involving the Impella heart pump.
3. Should the law firm accept the case, it will outline the terms of its engagement, often working on a contingency fee basis.

Understanding the types of evidence and knowing the statute of limitations can be crucial to a successful outcome.

While an out-of-court settlement is always the preferred resolution, if necessary, the lawsuit will proceed through Maryland’s arbitration panel, supported by expert testimony to establish negligence.

Types of Evidence To Present

The evidence presented is critical to establishing the link between the device and the injuries sustained when building a case for an Impella heart pump lawsuit.

The types of evidence that may be crucial include:

• Medical Records: These documents can demonstrate the usage of the Impella heart pump, the subsequent injuries or complications, and the treatments that were necessary as a result.
• Expert Testimony: Medical experts can provide insights into how the device may have malfunctioned and the expected outcomes versus the actual adverse effects experienced by the patient.
• Device Documentation: Information about the heat pump itself, including its design, instructions for use, and any warnings or recalls issued by the manufacturer or the FDA.
• Personal Testimony: The patient’s personal account of the impact the complications have had on their life, including pain and suffering, lifestyle changes, and emotional distress.
• Witness Statements: Testimonies from family members or healthcare providers who can corroborate the patient’s claims and speak to the extent of the injuries and the care required.
• Financial Records: Documentation of expenses related to medical treatment, rehabilitation, and any other costs incurred due to the malfunction of the Impella device.

By meticulously compiling and presenting these types of evidence, your legal team can build a robust case to support your claim for compensation due to the Impella heart pump’s complications.

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

The statute of limitations for the Impella heart pump lawsuit in Maryland is typically three years from the date the injury was discovered or reasonably should have been discovered, according to state law. This legal timeframe determines the period within which affected parties must initiate legal proceedings related to medical device complications.

Failure to file within this period could result in the loss of the right to compensation. Therefore, understanding and adhering to these deadlines is crucial for anyone considering legal action.

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

Get Your Free Consultation From Maryland Our Lawyers

At Schmidt & Clark, LLP we stand with you in times of adversity. Should you or someone close to you experience complications from the Impella heart pump device, we encourage you to reach out. Our seasoned team is adept at managing such cases and will navigate you through every stage of the legal process.

We’re committed to ensuring you understand your rights and determining if you qualify for a lawsuit. Offering free initial consultations, we operate on a contingency fee basis—you pay only when we win your case. Trust in our commitment to extend to you the same compassionate care we’d give our family members. Contact us for a comprehensive review of your situation.

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://medicine.wustl.edu/news/heart-pump-device-linked-to-serious-complications-in-some-patients-undergoing-heart-stent-procedure/
3. https://www.mddionline.com/regulatory-quality/abiomed-s-impella-now-linked-to-4-deaths-in-recent-recall