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Indiana Impella Heart Pump Lawsuit ( 2024 Update)

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Quick Summary

  • If you’re grappling with complications from an Impella heart pump in Indiana, you might be wondering about the current lawsuit status and how it could affect you.
  • Read on as this article covers the latest updates on the Indiana Impella heart pump lawsuit, the risks involved, and your legal options.
  • 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 with your claim by providing expert legal advice, navigating the complex legal system, and fighting tirelessly to secure the compensation you deserve.

At Schmidt & Clark, LLP, we pride ourselves on our ability to navigate the intricacies of medical device litigation. Our commitment is to not only uphold your rights and ensure your story is heard but also to provide personalized support at every turn.

Here’s how we can assist you:

  • Providing expert legal advice and representation in court
  • Gathering and managing evidence to strengthen your case
  • Holding negligent manufacturers accountable for their actions

Impella Heart Pump Lawsuit

The ongoing litigation surrounding the Impella heart pump has significant implications for patients, healthcare providers, and the medical device industry.

As Impella heart pump lawsuits continue to be filed, the focus intensifies on the experiences of those affected by the device’s potential malfunctions.

The legal actions undertaken by patients and their families are not just about seeking compensation; they represent a broader effort to hold manufacturers accountable and to ensure that safety is paramount in the development and deployment of life-sustaining medical devices.

The impact of these lawsuits extends beyond the courtroom, potentially influencing regulatory practices and device innovation to prevent future harm.

What Is an Impella Heart Pump?

An Impella heart pump is a medical device used to support blood flow in patients undergoing high-risk cardiac procedures. It functions by being temporarily placed into the heart, particularly during interventions like valvuloplasty and ventricular tachycardia ablation, to ensure adequate blood circulation.

With a flow rate of up to 5 liters per minute, the Impella heart pump plays a crucial role in maintaining circulation when the heart needs support most.

The Impella heart pump is inserted through a catheter in the femoral artery and positioned in the heart, with one end in the left ventricle and the other in the aorta to maintain blood flow.

Recognized as an advancement over previous technologies like the intra-aortic balloon pump, the Impella provides enhanced support and generally has a lower incidence of complications following procedures. It’s an essential tool for doctors, akin to a trusted co-pilot in critical moments.

While the Impella heart pump represents a significant advancement in medical technology, it is not without potential complications. Safety warnings and recalls for the device have raised concerns about its use and the associated risks.

Reasons Behind The Recall

According to the FDA, Class I recall, the highest level alert issued by the agency, signals serious concerns. This was the case with the Impella left-sided blood pumps, which faced recalls due to the risk of the pump catheter perforating the wall of the left ventricle – a rare but potentially fatal complication [1].

Over 66,000 devices were pulled from the U.S. market between October 2021 and October 2023, underscoring the gravity of the situation. These devices are commonly used in percutaneous coronary interventions, making the recall even more significant.

The discovery of non-reported complaints about the Impella devices came following an inspection at Abiomed’s headquarters. This raised concerns about the company’s reporting practices.

The fact that Abiomed did not immediately notify the FDA about the risk of the heart pump causing perforations, which only came to light after a bulletin was found during the inspection, was a matter of regulatory concern.

In response to the FDA’s scrutiny, Abiomed, which had by then become part of Johnson & Johnson MedTech, sent an Urgent Medical Device Correction letter with new warnings to all affected customers.

This measure, taken in December 2023, was a step towards mitigating the risks associated with the use of Impella devices. Yet, the acknowledgment of the issue as a ‘rare and known complication’ did little to assuage the fears of those who had already experienced complications.

Side Effects of Impella Heart Pump

Despite their innovation, Impella heart pumps have been linked to a range of complications, including acute heart failure and death. These risks aren’t just numbers on a page; they translate into real-world consequences for patients who trusted this technology with their lives.

The most harrowing of these risks are heart wall tears, which can lead to catastrophic outcomes like:

  • left ventricle perforation
  • heart wall perforations
  • severe hypertension
  • free wall rupture

The tearing risk is a chilling thought, especially for those who are already vulnerable, such as older adults, women, and individuals with pre-existing heart disease.

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 

How Do You Qualify for an Impella Heart Pump Lawsuit?

To qualify for an Impella heart pump lawsuit in Indiana, you must have suffered severe injuries such as heart wall tears, brain damage, or a devastating lack of blood flow due to the device. This also extends to families who are mourning the loss of a loved one due to complications from the Impella Heart Pump.

Even those who have faced the terror of a pump failure during critical procedures like heart surgery or who have suffered during operations involving a temporary blood pump may have a case.

It’s not just about the physical trauma; it’s about the emotional toll and the disruption to life as you knew it, especially when experiencing a blood flow death.

The Status Of The Impella Heart Pump Lawsuit Litigation in Indiana

The Indiana Products Liability Act (IPLA) is the compass guiding these cases, focusing on physical harm caused by defective products. Under the IPLA, a product may be deemed defective due to design flaws, manufacturing defects, or inadequate warnings or instructions.

According to the Society of Thoracic Surgeons, the statistics underscore the severity of the issue with 129 reported serious injuries and 49 fatalities linked to the use of the Impella heart pump [2].

Recognizing the significance of these numbers is essential, and for those considering legal action, a free case evaluation could be a constructive first step.

Impella Heart Pump Lawsuit Settlement Amounts in Indiana

The topic of settlement amounts in Indiana for Impella heart pump lawsuits is a complex and sensitive issue. It involves not only the intricacies of individual cases but also the broader implications of such settlements on the medical device industry and patient safety.

While specific settlement amounts can vary widely based on the details of each case, the overarching goal of these legal actions is to provide fair compensation to those who have suffered due to potential device malfunctions.

Seeking compensation goes beyond addressing financial imbalances caused by medical expenses; it’s also about securing justice for the harm suffered.

In Indiana, victims of pharmaceutical company negligence can seek solace in the law, which allows for the recovery of both economic and non-economic damages.

Economic damages extend beyond hospital bills to include lost wages and the potential earnings that vanished in the wake of injury.

The non-economic damages cover the spectrum of suffering from mental anguish to the profound loss of enjoyment in life’s simple pleasures. These are the aspects of your life that were unfairly taken from you, and the law acknowledges this theft.

Filing an Impella Heart Pump Lawsuit in Indiana

Initiating an Impella lawsuit in Indiana involves gathering the necessary documentation to paint a complete picture of your experience with the device.

This process entails compiling detailed records of the device acquisition, all medical expenses, and any hospitalizations that arose due to the device-related complications.

The goal is to establish a detailed chronology linking the use of the Impella heart pump directly to the subsequent injuries incurred.

Types of Evidence To Present

In the pursuit of a successful Impella heart pump lawsuit, the evidence you present is the cornerstone of your case. Here are the types of evidence that are instrumental:

  • Medical Records: These are the bedrock of your claim, including documentation of the Impella heart pump implantation, all related medical treatments, and detailed notes on the adverse effects you’ve experienced.
  • Expert Testimony: Medical professionals’ opinions can elucidate the connection between the heart pump and your injuries, providing the scientific backing for your claim.
  • Recall Notices and Manufacturer Communications: Official notices from the FDA and communications from the device manufacturer about Impella’s risks can highlight a pattern of known issues.
  • Photographic/Video Evidence: Visual proof of the injuries and their effect on your life can be a powerful ally in the courtroom, offering a glimpse into your lived experience.

By compiling these varied forms of evidence, you create a compelling narrative that not only supports your legal arguments but also humanizes your ordeal.

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

The statute of limitations for the Impella heart pump lawsuit in Indiana is two years from the date of injury. This time frame is critical for patients and families to take legal action and seek compensation for damages incurred due to the device.

Understanding the urgency of this deadline is paramount, as any delay could jeopardize your ability to file a claim.

Related Articles:

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

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At Schmidt & Clark, LLP we stand by your side 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 team is adept at managing such cases and will navigate you through every step of the legal process. We’re committed to ensuring you understand your rights and will evaluate if you have a viable claim, including issues related to applesauce lead contamination.

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