Heater Cooler Lawsuit

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Sorin Stöckert 3T heater-cooler lawsuits stem from serious bacterial infections tied to the devices. At least 210 heater-cooler lawsuits have been filed after patients suffered serious side effects like heart or lung infection, coughing up blood and abdominal abscesses. In December 2018, a Settlement Master was appointed to discuss possible settlement terms for Sorin 3T lawsuits in federal court, but no settlement has yet been announced.

Why Are People Filing Heater-Cooler Infection Lawsuits?

Sorin 3T devices use independent water tanks and a compression-based cooling system to keep patients at the desired temperature during surgery. However, bacterial contamination at Sorin's Germany-based factories, along with what seems to be poor design, has led to a significantly increased risk of developing deadly postoperative infections from nontuberculous mycobacteria (NTM).

NTM infections are serious bacterial infections caused by one of more than 150 types of bacteria, the most common of which are M. chimaera, M. abscessus and M. fortuitum. The use of NTM-contaminated Stöckert 3T heater-cooler devices in heart operations may increase the risk of these deadly infections by circulating the bacteria throughout the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) estimates that as many as 1 in 100 people could be affected by serious complications from an NTM infection after undergoing cardiac surgery. Symptoms can sometimes take months to appear, and they are often non-specific, making it difficult to diagnose the problem immediately. Some infections have not been discovered until months later, increasing the potential for serious complications, including a risk of death.

NTM Infection Symptoms

  • Unexplained weight loss
  • Night sweats
  • Muscle pain or aches
  • Unexplained fever
  • Chronic cough
  • Septic shock (sepsis)
  • Endocarditis (heart lining infection)
  • Coughing up blood (hemoptysis)
  • Pulmonary disease (lung infection)
  • Fatigue or malaise
  • Inflammation of lymph nodes (lymphadenitis)
  • Abscesses in the abdomen, aorta or heart valve

As a result of these potentially fatal heater-cooler infections, dozens of individuals have filed lawsuits against Sorin Group. In February 2018, the U.S. Judicial Panel on Multidistrict Litigation consolidated 40 of these cases from 21 districts into a single MDL (No. 2816) in the Middle District of Pennsylvania. More than 30 other lawsuits are filed in state courts across the United States and could be consolidated into the MDL in the future. Some defendants have claimed that their NTM infections were caused by M. chimera bacteria that originated at Sorin's heater-cooler manufacturing plant in Germany, while others have alleged that their infections were caused by M. abscessus, which is more commonly found in North America.

You or a loved one could be eligible for compensation to pay for treatments and related costs, regardless of which type of NTM bacteria caused an infection. Get a free case review and find out if you can file a heater-cooler lawsuit.

FDA and CDC Investigation of Heater-Cooler Devices

of coronary artery bypass surgeries in the U.S. use heater-cooler devices that can cause infection.CDC

In 2015, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) published alerts stating that contaminated Sorin Stöckert 3T heater-cooler devices could put patients at increased risk of getting a life-threatening mycobacterial infection. The alerts came after the publication of a study by a group of researchers in Switzerland, who discovered two cases of infective endocarditis in post-cardiac surgery patients. Additional safety communications were published in 2016.

The FDA subsequently opened a still-ongoing investigation into the safety of heater-cooler devices and their role in postoperative NTM infections, particularly after cardiothoracic surgeries. To date, the FDA has identified three potential causes related to these infections:

  • Heater-cooler filters: Some heater-cooler devices have air or water filters, but not all of these filters are able to sufficiently prevent NTM bacteria from contaminating the system.
  • Airborne bacteria: Water tanks in the cooling area of the heater-cooler device could become contaminated with NTM bacteria. This contaminated water could then indirectly contaminate other equipment and materials.
  • Laminar airflow interruption: A technique called laminar airflow is sometimes used to sterilize the space above a surgical site. Exhaust from the heater-cooler system could disrupt the laminar space, causing bacteria to enter the otherwise sterile area.

The FDA issued a new Safety Communication regarding the Sorin 3T Heater-Cooler System in February 2020. It includes several guidelines aimed at reducing the infection risk associated with this device.

FDA Recommendations for Reducing Heater-Cooler Infections

  • Strictly follow the manufacturer's operating instructions.
  • Use brand new tubing and connectors when switching devices.
  • Direct exhaust from the device away from the patient.
  • Remain vigilant about device contamination from other environmental sources.
  • Clean and disinfect all accessories according to manufacturer instructions.
Source: FDA.gov

The FDA is continuing to work with hospitals, clinics, and other healthcare networks to implement better infection control procedures for mycobacterium chimaera infections associated with heater-cooler devices.

Heater-Cooler Class Action Lawsuits and MDLs

Heater-cooler lawsuits against Sorin Group and affiliated companies, including Cyberonics Inc. and LivaNova PLC, allege that the companies should have known that its 3T heater-cooler systems could spread bacteria and potentially cause life-threatening infections. With nearly a quarter million open-chest surgeries per year in the U.S., thousands of infected patients may be eligible for legal damages, although only a few dozen lawsuits have been filed in federal and state courts.

Federal Multidistrict Litigation (MDL No. 2816)

In 2017, an attempt was made to consolidate 16 lawsuits using federal rules of multidistrict litigation. However, at the time, there were not enough cases to warrant consolidation, especially since 10 of the cases were already being overseen by a single judge.

In February 2018, with more and more heater-cooler lawsuits against Sorin being filed, plaintiffs renewed their motion for consolidation. This time, the Judicial Panel on Multidistrict Litigation approved the request, assigning the cases to the Middle District of Pennsylvania under MDL No. 2816.

Multidistrict litigation provides more efficient procedures for pretrial motions, discovery, and other phases of the trial process. However, MDL cases are still considered individual lawsuits rather than class actions.

Iowa Class Action Lawsuit

In May 2017, Jeri Pickrell filed a lawsuit on behalf of herself and similarly situated persons in Iowa against Sorin relating to complications after being exposed to deadly bacteria during cardiothoracic surgery. This class action lawsuit covers anyone who was exposed to M. chimaera or M. abscessus variations of NTM bacteria because of a Sorin 3T heater-cooler system.

Included in the lawsuit is the recognition that in February 2016 the University of Iowa Hospitals and Clinics sent letters to more than 1,700 patients who had been exposed to bacteria during bypass surgery. Later in 2016, another Iowa hospital, Mercy Medical Center, made a similar announcement about the exposure of 2,600 patients to NTM bacteria during open-heart surgery.

Pennsylvania Class Action Lawsuit

In February 2016, two men in York County, Pennsylvania, filed a class action lawsuit against Germany-based Sorin Group Deutschland and its American affiliate, Sorin Group USA, due to infections originating from the company's Sorin 3T Heater-Cooler System. Edward Baker and Jack Miller claimed that they and thousands of others were exposed to bacteria during heart surgery.

As in Iowa, two Pennsylvania hospitals had announced exposure to NTM bacteria for a combined 3,600 patients who underwent cardiac operations between 2011 and 2015. Penn State Hershey Medical Center notified 2,300 patients of the bacterial exposure, while York Hospital sent notices to approximately 1,300 patients for the same reason. The class including all of these patients was certified in October 2017 in the U.S. District Court for the Middle District of Pennsylvania, although Sorin's parent company LivaNova had previously been excluded as a defendant.

South Carolina Class Action Lawsuit

Steven Foster filed a class action lawsuit against Sorin in January 2017 for the same reasons as other patients. Like in other states, the legal claims relied in part on announcements by two South Carolina healthcare providers about the exposure of patients to potentially fatal bacteria. The Greenville Health Hospital System reported 15 deaths tied to postoperative mycobacterial infection with 180 additional people having been exposed. Palmetto Health Richland Hospital reported two deaths and several hundred additional exposures to possibly lethal bacteria.

Foster's class action lawsuit was later withdrawn.

Heater-Cooler Lawsuit Settlement

On December 3, 2018, Judge John E. Jones, III, issued a case management order appointing a Settlement Master, Randi Ellis, for Sorin 3T lawsuits that have been transferred to MDL 2816. As part of the order, Judge Jones required both sides of the case to meet with Ellis to discuss terms of a potential settlement for all heater-cooler lawsuits in the MDL.

In March 2019, LivaNova announced a settlement that would resolve about 75% of the outstanding Sorin 3T lawsuits with a total payment of up to $225 million.  This settlement covered all pending cases in the MDL, as well as a federal class action lawsuit and certain state lawsuits. Payments were made in two batches, the first in July 2019 ($135 million) and the second in January 2020 ($90 million).

Heater-Cooler Lawsuit FAQs

How Can I Pay for a Heater-Cooler Lawsuit?

Many people are understandably concerned about the costs of filing a medical device lawsuit, especially if they already have a large number of medical bills piling up. Lawsuits in personal injury cases like this one are generally pursued on a contingency basis. This means that you will not be required to pay any upfront costs. You will only pay legal fees once you get compensation through a settlement or verdict.

Can I File a Lawsuit on Behalf of My Child?

Unfortunately, a number of children who required heart surgery have been affected by bacterial infections after their surgical procedures. If you are the parent of a child who experienced complications or died due to an NTM infection, you may be able to file a lawsuit against Sorin Group to help pay for medical bills and other expenses.

Is There a Heater-Cooler Lawsuit Settlement?

As of January 2019, no heater-cooler lawsuit settlement has been announced. While it is possible that a settlement could be reached before the first bellwether trial concludes due to the appointment of Settlement Master Randi Ellis, Sorin may also wait to see how juries rule in early verdicts before making a settlement offer.