Connecticut Impella Heart Pump Lawsuit (2024 Update)

Quick Summary

• As the Connecticut Impella heart pump lawsuit unfolds, affected individuals are seeking answers. This article cuts through the complexity to provide an understanding of the legal allegations, patient rights, and FDA responses that are shaping this critical case.
• If you or a loved one has experienced adverse effects from the Impella heart pump, the legal team at Schmidt & Clark, LLP stands ready to support you. Renowned for our expertise in representing plaintiffs, we are committed to ensuring that you receive the justice and compensation you are entitled to.

How S&C Can Help With Your Claim?

S&C can help with your claim by providing expert legal guidance and representation throughout the entire process. Our experienced team will work tirelessly to ensure that your voice is heard and that you receive the compensation you deserve for the hardships you’ve endured.

At Schmidt & Clark, LLP, we provide comprehensive support for your Impella heart pump lawsuit by:

• Collecting and organizing all necessary medical records and documentation to build a strong case.
• Navigating the complexities of medical device litigation to advocate for your rights and interests.
• Offering personalized attention and care to alleviate the stress of legal proceedings, allowing you to concentrate on your recovery and health.

Impella Heart Pump Lawsuit

The Connecticut Impella heart pump lawsuit represents a significant legal challenge that underscores the risks patients may encounter when medical devices malfunction.

The lawsuit has been filed in response to concerns that the Impella heart pumps, devices designed to support patients’ cardiac function, may have contributed to severe complications instead of providing the intended benefits.

Heart surgery patients, putting their trust in these pumps, were left grappling with serious adverse health consequences that could alter their lives forever.

Central to the lawsuit are the allegations that Abiomed may not have provided sufficient warnings and could have overlooked potential flaws in the design or manufacturing of the Impella heart pumps.

The legal action focuses on patients who suffered severe complications such as left ventricle perforation or free wall rupture after being treated with an Impella heart pump.

What Is an Impella Heart Pump?

An Impella heart pump is a minimally invasive medical technology designed to help maintain blood flow for patients with coronary artery disease or those experiencing cardiogenic shock.

In the context of heart surgery, these pumps support the heart by unloading it and preserving blood flow to vital organs during essential procedures. Equipped with SmartAssist Technology, the devices also provide real-time data that can be crucial for optimizing patient outcomes during surgery.

Impella heart pumps are crucial during heart surgeries, maintaining blood flow in patients with severe cardiac issues. Inserted via the thigh, they navigate to the heart, ensuring its function during critical moments.

Some Impella heart pump models, specifically the Impella 2.5 and Impella CP, have been involved in legal actions due to complications.

These models, along with others like the Impella 5.0 and Impella 5.5 with SmartAssist, were part of an FDA alert that brought attention to the issues within the medical community. The alert specifically mentioned the affected Impella pumps and prompted a review of their safety and performance.

Reasons Behind The Recall

The FDA’s responsibility is significant – they ensure that medical devices such as the Impella pumps satisfy rigorous standards for safety and performance. When these standards are not met, they respond with appropriate recalls and safety alerts.

According to the Society of Thoracic Surgeons, the implications were far-reaching, with a staggering 66,390 devices included in the recall, classified as Class I. The recall was a clear signal of the potential for serious injuries or death associated with the use of these devices [1].

The FDA’s safety warnings serve as beacons of caution in a sea of medical devices. In their high-level alert, the FDA admonished Abiomed for not reporting the heart wall tear risk sooner risk known since 2018. The discovery of this unreported risk during an inspection at Abiomed’s headquarters led to an Urgent Medical Device Correction letter, urging customers to adhere to the new and revised warnings.

These warnings included guidelines for careful positioning of the pump catheter and the use of imaging to mitigate the risk of heart attack and other life-threatening conditions.

Side Effects of Impella Heart Pump

While designed to be life-saving, Impella heart pumps have come under scrutiny due to reports of adverse events, including serious injuries and some fatalities.

This has raised concerns about the devices’ safety profiles, as issues such as heart perforation and free wall rupture have been identified as possible risks of their use.

In response, the Impella heart pumps were subject to recalls, highlighting the importance of addressing the risks that patients may encounter. Discussing serious injuries in the context of heart pumps extends beyond minor issues.

We’re talking about the kind of injuries that can lead to:

• Acute heart failure
• Hypertension
• Impaired blood flow
• Heart wall tears
• In the worst cases, blood flow death.

With 129 reported serious injuries and 49 deaths, the stakes couldn’t be higher. Take, for instance, a 75-year-old man whose brush with death came in the form of a left ventricular rupture post-Impella device insertion, necessitating an emergency operation to repair his heart wall.

However, it’s important to acknowledge that despite the complications associated with Impella heart pumps, research has shown that many patients—80%—experience improvement in heart failure symptoms or an increase in heart ejection fraction after treatment.

How Do You Qualify for an Impella Heart Pump Lawsuit?

To qualify for an Impella heart pump lawsuit in Connecticut, you must have experienced severe injuries or the loss of a family member due to complications with the device.

Specific injuries that may warrant legal action include cuts to the left ventricle, perforation, or tears in the heart wall—serious conditions that underscore the gravity of the device’s potential failings.

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 Connecticut

The ongoing legal battle in Connecticut regarding the Impella heart pump is a pivotal case that is being closely monitored by legal experts, medical professionals, and patients alike.

As the proceedings develop, the intricate details of the lawsuit are being dissected in court to ascertain the accountability of the device manufacturer and to seek reparations for those who have suffered.

This litigation is significant not only for the plaintiffs directly involved but also for the broader implications it may have on medical device regulation and patient safety protocols. With each court session, new information comes to light, contributing to the complex narrative of this high-stakes lawsuit.

Impella Heart Pump Lawsuit Settlement Amounts in Connecticut

The settlement amounts in the Connecticut Impella heart pump lawsuit are crucial for those affected by this medical device. Settlements are typically the result of negotiations between the plaintiffs and the defendant, in this case, Abiomed, the manufacturer of the Impella heart pumps.

While the actual settlement amounts are often confidential and can vary widely based on the specifics of each case, they generally reflect the severity of the injuries suffered, the impact on the quality of life for the victims, and the degree of negligence or fault that may be attributed to the manufacturer.

In cases like these, compensation can cover a range of damages, including medical expenses, lost wages, pain and suffering, and, in the event of a fatality, wrongful death. The settlement amounts are also influenced by the strength of the evidence presented and the legal representation’s ability to argue the case effectively.

Understanding the potential value of a claim in the Impella heart pump lawsuit requires expertise in both the legal and medical fields. Affected parties need to consult with attorneys who are experienced in medical device litigation to ensure they receive the maximum amount of compensation they are entitled to.

As the Connecticut lawsuit progresses, the outcomes of these settlements will likely set a precedent for similar cases, potentially influencing the strategies of both plaintiffs’ and defendants’ legal teams in future litigation related to medical device malfunctions.

Filing an Impella Heart Pump Lawsuit in Connecticut

For those in Connecticut grappling with the aftermath of an Impella heart pump procedure gone awry, the path to justice begins with a step toward legal representation.

Law firms specializing in medical device litigation are the beacon for these individuals, offering free consultation to navigate the murky waters of their circumstances.

The possibility of pursuing a lawsuit brings with it the hope of a settlement, a recognition of the suffering endured, and a potential catalyst for change in the industry’s approach to product safety.

Types of Evidence To Present

When building a case for the Impella heart pump lawsuit, it’s essential to compile a comprehensive array of evidence that supports the claim of negligence or product liability.

This evidence can include but is not limited to:

• Medical records
• Expert testimony from medical professionals
• Documentation of FDA recalls
• Financial records
• Correspondence with the manufacturer

Presenting a well-documented case with strong evidence is crucial to establishing the merits of the lawsuit and achieving a successful outcome for the claimant.

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

The statute of limitations for the Impella heart pump lawsuit in Connecticut is typically two years from the date the injury is sustained or discovered. This legal timeframe determines the period within which affected parties must initiate their legal proceedings.

Due to the critical nature of adhering to this timeframe, potential claimants are encouraged to seek legal counsel promptly to ensure their case is filed within the state-mandated deadline. It is important to note that specific circumstances may influence this period, and legal experts can provide guidance on whether exceptions apply to your situation.

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

Get Your Free Consultation From Our Connecticut Lawyers

Schmidt & Clark, LLP stands beside you in these trying times. Should you or someone close to you have experienced complications from the Impella heart pump, we encourage you to get in touch.

Our seasoned legal team specializes in these complex cases and will navigate you through every step of the legal process. We’re committed to making sure you understand your rights and determining if you’re eligible for a lawsuit regarding Impella heart pump complications.

Our initial consultation is free of charge, and our fees are contingent on securing a victory for your case. 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