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What To Do If You Received A Letter From The Hospital...

About Potential Exposure During Your Surgery To A Non-Tuberculosis Mycobacteria (NTM) Infection Called “M. Chimaera”...

And You Have Indeed Developed This Infection...

or Suspect You May Be Infected Based On Present Symptoms...

From the desk of:
Andy Bederman, Managing Attorney

Dear Friend,

If this happened to you (or a loved one), then this may be the most important message you will read...

Details at a Glance:
  • A device used in heart, lung and liver surgeries called the Stockert® 3T Heater-Cooler™ has been found to cause deadly bacterial infections with patients
  • Device was used between 2012 and 2016 in 65% of U.S. hospitals
  • The specific infection is a non-tuberculous mycobacterial (NTM) infection called “M. chimaera”
  • M. chimaera and other NTM infections are very difficult to detect
  • Infected patients may not develop signs of infection for months to even years after surgery where exposure occurred
  • Estimated as many as 1 in 100 patients could have been exposed to NTM bacteria where device was used in surgery
  • Likely 500,000+ patients at risk
  • FDA and CDC heavily involved -- issued Safety Alerts to doctors and hospitals as well as warning letter to manufacturer
  • Many reports of life-threatening infections -- thus far a 50% mortality rate for those infected
  • Lawsuits are being filed against device manufacturer (LivaNova, PLC)
  • Claims they knew this device was contaminated with deadly bacteria, but didn’t pull off market and continued to sell
  • Lawsuits also claim failures to warn, failures in manufacturing and failures in design
  • Our law firm is investigating these cases
  • We help infected patients (and their families) seek recovery in the form of financial compensation
  • We are offering free legal consultations (click here for information)

What Is The Stockert® 3T Heater-Cooler™?

The Stockert® 3T Heater-Cooler™ is a device used during heart, liver and lung surgeries to keep patients warm or cool.

This device regulates the patient’s body temperature by forcing temperature-controlled water into external heat exchanges or special surgical blankets that wrap the patient.

It is estimated that 65% of hospitals in America used the Stockert® 3T Heater-Cooler™ device during major heart, lung and liver surgeries.

Perhaps over half a million (500,000+) patients in the U.S. have had surgery that used this device.

Surgeries That Used the 3T Heater-Cooler™:

Below is a list of the most common heart, liver and lung surgeries the Stockert® 3T Heater-Cooler™ was used in:

  • Cardiac and Cardiothoracic Surgeries
    • Heart bypass surgery
    • Cardio-pulmonary surgery
    • Coronary artery bypass
    • Open-heart surgery
    • Heart transplants
    • Ventricular implants
    • Aorta procedures
    • Pulmonary artery surgery
  • Liver Surgeries
    • Liver transplants
    • Liver resection (removal of tumor)
    • Partial hepatectomy
  • Lung Surgeries
    • Lung transplants
    • Pulmonary artery surgery
    • Lung resection surgery

Below is an illustration of the 3T Heater-Cooler™ device:

3T Heater Cooler Infection Lawsuit

What Was Wrong With the Stockert® 3T Heater-Cooler™?

The Stockert® 3T Heater-Cooler™ was found to have been contaminated with a deadly non-tuberculous mycobacteria (NTM) called “M. chimaera”.

The device spread this bacteria during surgery, exposing patients to a life-threatening infection.

Research found that the bacteria can become airborne via the device’s exhaust vent -- filling the operating room and ultimately finding its way into the surgical site of the patient.

The 3T Heater-Cooler™ was likely contaminated with “Mycobacterium Chimaera” while in production -- as testing found M. chimaera contamination in the water supply and production line at the 3T Heater-Cooler™ manufacturing facility.

What is Non-Tuberculosis Mycobacteria (NTM) “M. Chimaera”?

Mycobacterium Chimaera is a non-tuberculosis mycobacteria (NTM) that can cause a life-threatening infection in people.

A unique characteristic of M. chimaera is the length of time that infection can go undetected.

Patients infected with M. chimaera (and other NTM infections) may not develop any signs or symptoms of infection for many months to even years after initial exposure.

This makes NTM infections extremely difficult to detect. There are also no known screening tests to determine if a patient has been exposed.

What Are The Signs & Symptoms of NTM (M. Chimaera) Infection?

The common signs and symptoms of an NTM (M. chimaera) infection are many -- and can often be subtle at first onset.

Those who are already immune compromised are more likely to develop these symptoms, which could signal an infection:

  • Fever
  • Fatigue or malaise
  • Pain (abdominal, joint, or muscle pain)
  • Night sweats
  • Nausea or vomiting
  • Difficulty breathing
  • Redness, heat or pus at surgical site
  • Unexplained weight loss
  • Endocarditis (infection of heart’s inner lining)
  • Abscess
  • Bacteremia (bacteria in the blood)
  • Hepatitis
  • Splenomegaly (enlarged spleen)
  • Renal insufficiency (poor kidney function)
  • And more...

What Is The Food and Drug Administration (F.D.A.) Saying About This?

On December 29th, 2015, the Food and Drug Administration (FDA) sent a warning letter to LivaNova, PLC (also known as Sorin Group Deutschland GmbH) regarding its Stockert® 3T Heater-Cooler™ device.

The FDA’s warning letter to LivaNova, PLC was a scathing outline of the many violations that were uncovered by the FDA’s inspection of their facilities.

Among the many violations the FDA found, the most critical was:

Failing to adequately validate procedures for the effective cleaning and disinfection of 3T Heater-Cooler™ device parts

Research suggests it may be this violation that contributed to the resulting infections in patients.

Following the FDA’s warning letter to the manufacturer, NTM infections of M. chimaera were being increasingly reported and the association between NTM infections and the 3T Heater-Cooler™ was solidified.

On June 1, 2016, the FDA issued a Safety Communication to all healthcare providers warning of the newly discovered link between the Stockert® 3T Heater-Cooler™ and M. chimaera (NTM) infections.

The FDA’s most notable recommendation to hospitals and surgeons in this Safety Communication was:

Immediately remove from service any Heater-Cooler™ devices, accessories, tubing, and connectors that have tested positive for M. chimaera or have been associated with known M. chimaera patient infections at your facility

How Many People Were Infected?

The Centers for Disease and Prevention (CDC) has estimated that more than half a million (500,000+) patients who had open-chest surgeries since 2012 could be at risk for the deadly “M. chimaera” infection linked to 3T Heater-Cooler™ use.

Perhaps the most common surgery where the 3T Heater-Cooler™ was used was in heart bypass procedures. There are over 250,000 bypass procedures performed each year. Of those, 60% are estimated to have used the 3T Heater-Cooler™.

Hospitals have been trying to send out letters to surgical patients that may have been exposed, in an attempt to warn people of possible infection and the signs and symptoms to look out for.

Already, there many reports of these individuals being infected with (NTM) M. chimaera.

Sadly, the mortality rate of this infection is about 50%. And half of those reporting they were infected have died.

The Cleveland Clinic is reporting, however, that the antibiotics azithromycin, clarithromycin and rifabutin are showing effectiveness in treatment of this rare M. chimaera NTM infection.

Are These Infections The Manufacturer’s Fault?

Investigations into the cause of these contaminated 3T Heater-Cooler™s have yielded some troubling insights into the possible negligence of the manufacturer, LivaNova, PLC.

In August 2014, LivaNova, PLC (the manufacturer) had conducted its own testing (prior to FDA awareness of such contamination) for M. chimaera (NTM).

It is important to note, this internal testing was done well before the FDA’s initial awareness of infections, and also before FDA’s inspections and issuing of safety communications about the 3T Heater-Cooler™.

LivaNova PLC (the manufacturer) already knew about M. chimaera (NTM) contamination within their facility’s production line and water supply, but failed to pull the potentially contaminated 3T Heater-Cooler™ devices off the market.

LivaNova, PLC also continued to distribute (sell) these potentially contaminated devices worldwide, and thus surgeries from 2012 to 2016 were still using these potentially NTM (M. chimaera) contaminated machines.

Why Are Lawsuits Being Filed Against The Manufacturer?

LivaNova, PLC (the manufacturer) was aware that their 3T Heater-Cooler™ devices were potentially contaminated with a deadly bacteria, yet continued to sell them worldwide.

Lawsuits involving the Stockert® 3T Heater-Cooler™ are now being filed on these grounds:

  • Failure to Warn (LivaNova, PLC did not properly warn healthcare providers of known risks)
  • Failure to Have Adequate Cleaning & Disinfection Procedures for Manufacturing Process (as detailed in the FDA warning letter and inspection findings)
  • Failure to Design A Reasonably Safe Device (the 3T Heater-Cooler™ was not designed to allow for cleaning and disinfection of internal circuits and water tank -- which allowed biofilm to form on parts)

A 3T Heater-Cooler™ class action lawsuit was recently filed in Pennsylvania federal court that seeks class action status for over 3,600 patients who had surgery at hospitals in Pennsylvania.

Other claims are beginning to be filed in other courts as well across the U.S.

While those that were infected with (NTM) M. chimaera should seek immediate legal counsel -- our law firm will not advocate that patients participate in a “class action” tort claim. Rather, it is likely far more beneficial for infected patients to pursue compensation with an individual lawsuit or settlement.

Why Should I Consider Pursuing Financial Recovery With An Individual Lawsuit, As Opposed To A Class Action Lawsuit?

An infection of (NTM) “M. chimaera” is life-threatening.

Developing such a serious infection with a 50% mortality rate is devastating and requires the absolute finest in infectious disease treatment and care.

Sadly, many reading this may have already lost a loved one to this tragic infection -- caused by the potential negligence of a device manufacturer that failed to warn healthcare providers of the M. chimaera contamination problems.

However, our law firm is not advocating infected patients to seek participation in a “class action” style lawsuit or settlement -- as this is generally less beneficial than filing individually -- especially for patients that developed the NTM (M. chimaera) infection.

Rather, we advocate that an infected patient pursue an individual lawsuit or individual settlement -- as this approach will typically yield far greater financial recovery for you than if you participate in a “class action” lawsuit.

How Would Filing An Individual Lawsuit Benefit Me?

This devastating infection can have an equally devastating impact on your well-being (or the well-being of your loved one).

The impacts to your physical health, emotional health and financial well-being are significant -- and you should not have to bear this burden because of the possible negligence of a device manufacturer that could have prevented this from happening.

Medical device manufacturers are subject to strict guidelines and rules by the FDA. The FDA puts rules in place that require manufacturers to have adequate device cleaning and disinfection procedures, as well as requiring procedures for the extensive testing and reporting on the safety of their device.

These FDA rules are required to be met even before a medical device can be sold to, and used in, hospital operating rooms.

This is done so hospitals and surgeons can weigh the benefits of using a particular heater cooler device against the possible dangers and consequences it may pose.

And it gives doctors the ability to make an informed decision about which brand heater cooler device to use, based on available safety data gathered in pre-market testing and trials.

When A Manufacturer Is Negligent In Regards to the Safety of A Medical Device, Both Doctors & Patients Become Victims

Because the Stockert® 3T Heater-Cooler™ has caused patients to develop this deadly (NTM) M. chimaera infection, patients are finding themselves burdened with substantial medical expenses, lost wages, a decreased quality of life, and more.

For this, you may be entitled to what are called "damages", which is a legal term for financial compensation awarded in individual lawsuits, settlements or class action lawsuits.

What Your Next Step Should Be If You Developed The NTM Infection of Mycobacterium Chimaera

Our legal team has reviewed the available evidence, and our experience in medical device liability cases tell us that we are in prime position to help patients who are victims of the Stockert® 3T Heater-Cooler™ and the associated infections caused by the device.

We are offering a free legal consultation and case evaluation to patients (or loved ones) who believe they were affected by this device and infection.

If you'd like to learn more and have a conversation with our defective medical device lawyers free of charge, this is your opportunity to discover the help that is available to you.

Getting started is simple...

Fill out the contact form below or call us at 888-550-7931 for a free legal consultation (including a free case evaluation with an attorney). We will personally speak with you about your case.

This consultation with an attorney does not cost you anything and is 100% free and confidential.

You will speak to our attorneys -- lawyers with years of experience getting successful legal outcomes for victims of medical devices.

We are currently accepting cases nationally in the U.S., so you are eligible to speak with us -- no matter what state you live in.

You should contact our firm if you underwent surgery where the 3T Heater-Cooler™ device was likely used (ie. heart, lung or liver surgeries), and:

  • You (or a loved one) are experiencing the following symptoms, which could be a sign of possible infection, including...
    • Fever
    • Fatigue or malaise
    • Pain (abdominal, joint, or muscle pain)
    • Night sweats
    • Nausea or vomiting
    • Difficulty breathing
    • Redness, heat or pus at surgical site
    • Unexplained weight loss
    • Endocarditis (infection of heart’s inner lining)
    • Abscess
    • Bacteremia (bacteria in the blood)
    • Hepatitis
    • Splenomegaly (enlarged spleen)
    • Renal insufficiency (poor kidney function)
  • You (or a loved one) developed the non-tuberculosis mycobacteria (NTM) infection of “M. Chimaera”
  • We recommend patients act quickly -- because there is a only a small window of time that victims of the 3T Heater-Cooler™ can file a lawsuit or seek a settlement. This is called the "statute of limitations" -- and it is different for every state.

    So act now and fill out the contact form at the bottom of the page. Or simply pick up the phone and call us right now at 888-550-7931.

    We stand ready to help you with your case.

    Sincerely,

    Andy E. Bederman
    Managing Attorney
    Law Offices of Greenberg & Bederman, LLC

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