Overview of The Problem
The Stockert 3T heater-cooler is a machine used during open heart surgeries to control a patient’s body temperature.
The FDA and CDC recently issued a warning regarding the risk of infection associated with the 3T heater-cooler (see “Additional Resources Below”).
The Stockert 3T has been shown to circulate a rare bacteria known as M. chimaera, which can cause life threatening infections. Research has shown that the Stockert 3T was contaminated with M. chimaera during the manufacturing process in Europe. The bacteria forms a microfilm on the inner surfaces of the device, and can be spread to patients when the machine is used during surgery. The Stockert 3T should never have been contaminated with M. chimaera, and the bacteria should not have been allowed to spread. This has outraged patients who suffered infections after undergoing surgeries where a Stockert 3T heater-cooler was used.
CDC Issues Warning For Heart Surgery Patients
Stockert 3T Heater-Cooler Infections
When a patient undergoes a surgical procedure, they are entitled to a reasonable expectation that the machines used during their surgery are not contaminated with a potentially life-threatening bacteria. However, the contamination of the Stockert 3T devices in their manufacturing facility shattered those expectations. Specifically, this device uses a water tank and a circulation system to warm and cool a patient’s blood during surgery. However, depending on where the machine is located in the operating room, an exhaust fan on the machine can actually spread the oftentimes deadly M. chimaera bacteria across the operating room and into the patient’s exposed chest cavity; causing a variety of infection complications.
Understanding M. Chimaera Infections
In order to help you better understand M. chimaera infections, we have put together the following illustration. We have found that many physicians only test infections to the nontuberculous mycobacteria (NTM) or mycobacterium avium complex (MAC) level. If you have been diagnosed with any of these infections after a surgical procedure where the Stockert 3T device was used, you should consider getting additional testing to determine if you have in fact been infected with M. chimaera.
Hospitals With Confirmed Cases of M. Chimaera Infections
Below is a list of hospitals our lawyers believe, based upon our own clients’ experiences and court filings) that have produced confirmed cases of M. chimaera infections.
- Kaiser Permanente Medical Center – Los Angeles, CA 90027 (Warning Letter from Kaiser)
- Cedars-Sinai Medical Center – Los Angeles, CA 90048
- University of Iowa Hospitals and Clinics – Iowa City, IA 52242
- Mercy Medical Center – Des Moines, IA 50314
- Mayo Clinic – Rochester, MN 55905
- Regions Hospital – St Paul, MN 55101
- NYU Langone Medical Center – New York, NY 10016
- WellSpan – York, PA 17403
- Sanford Medical Center – Sioux Falls, SD 57106
- CHI Memorial Health – Chattanooga, TN 37404
- Johnson City Medical Center – Johnson City, TN 37604
- Christiana Hospital – Newark, DE 19713
IMPORTANT NOTE: This is not intended to be a complete list of hospitals where we believe an M. Chameara infection has been identified. If the hospital where you received your open chest surgery is not listed, we would still like to speak with you as soon as possible. Time is of the essence in these types of cases. We expect this list of hospitals where the defective Stockert 3T heater-cooler device was used to increase as more patients and more of our clients get their M. Chimaera test results back from their physicians.
Stockert Complaint For Damages, Jury Trial Demanded
If you have been diagnosed with M. Chimaera, you know firsthand that you have been infected with a life-altering bacteria. We believe in maximizing our clients potential recovery in these types of cases. As a result, we prepare each and every case we handle for trial and we will never settle a case without permission form our clients. Learn more about us by visiting Why Choose Johnson // Becker.
Stockert 3T Heater-Cooler Lawsuits
Below are links to a few of the Stockert 3T heater-cooler and M. chimaera lawsuits Johnson // Becker has filed.
Reading through these Complaints can give you a better understanding of the case that we are bringing against the manufacturer of the contaminated 3T heater-cooler machines. If you have any questions, please call us at (800) 279-6386.
- Case No. 2:17-cv-7802 – United States District Court – Central District California, Stockert 3T lawsuit
- Case No. 4:18cv3027 – United States District Court of Nebraska, M. chimaera lawsuit
- Case No. 17-cv-4186 – United States District Court for The District of Minesota, NTM lawsuit
- Exhibit for Stockert 3T heater-cooler complaints in litigation (this contains very good information)
What is Nontuberculosis Mycobacteria?
Nontuberculous mycobacteria (NTM), also known as as environmental mycobacteria, mycobacteria other than tuberculosis (MOTT) or atypical mycobacteria, are types of mycobacteria which do not cause tuberculosis or leprosy. NTM can cause cases of pulmonary diseases that mirror the symptoms of tuberculosis. NTM disease most often presents as lung disease, but lymphatic, skin/soft tissue, and disseminated disease have also be attributed to NTM. Symptoms of NTM disease vary widely and are often generalized in nature, making them extremely hard to diagnose (which is why it is thought that it took so long for doctors to draw the parallels between the Stockert 3T heater-cooler and the infections patients were suffering from.)
Nontuberculosis Mycobacteria & M. chimaera Infection Symptoms
People who have been infected with Nontuberculous mycobacteria (NTM) often undergo a frustrating and painful road to recovery. This is because this rare form of bacterial infection is not generally included on infection culture tests. The disease also presents a broad set of symptoms that are easily mistaken for other conditions. However, if you or a loved one has experienced two or more of the following symptoms after undergoing a heart surgery, contact your health care provider immediately:
- Weight loss
- Lack of appetite
- Night sweats
- Blood in the sputum (phlegm)
- Loss of energy
Like tuberculosis (TB), nontuberculous mycobacteria (NTM) and M. chimaera infections also affect the lungs. Because of that, the condition is often mistaken for TB initially. Only a doctor can properly diagnose and treat TB and NTM infections.
Typical Treatment for Patients Infected With M. Chimaera
Once a cultured sample has tested positive for M. chimaera, our lawyers have found that a fairly similiar protocol for treatment (although this may vary from patient to patient) is often utilized.
First the patient will typically be admitted to the hospital and given an IV, usually containing some mixture of one or more of the following antibiotics: Azithromycin, Rifampin/Rifabutin, Ethambutol, Amikacin, and Vancomycin (occasionally also including Moxifloxacin). Treatment is often scheduled for a year to “indefinitely” depending on patient progress.
Depending on how well the patient does towards the end of their hospital stay, the physician may switch the patient to oral antibiotics or send the patient home with “in-home” antibiotic infusions”. In some instances, antibiotic treatment may be prescribed for life.
Additionally, if the patient is healthy enough, the physician and surgeon may opt for a re-do surgery to take out any infected prosthetic, oftentimes an artificial heart valve. For patients that are well enough to undergo this replacement surgical procedure, it is thought that this “re-do” of the past surgery is the best way to increase the patients odds of survival.
Stockert 3T Heater-Cooler And The FDA
The Stockert 3T heater-cooler system has been under scrutiny from the FDA for years, but only recently did the federal agency issue a comprehensive look into how the machine was causing Mycobacterium chimaera (M. chimaera) infections. In a Safety Communication published in October of 2016, FDA intended to “help prevent the spread of infection related to the use of these devices.” The paper drew into question the safety of LivaNova PLC’s device by saying,
“Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.”
The Safety Communication went on to detail a link between M. chimaera infections and the 3T system.
Specifically, the Safety Communication noted that “Testing conducted by the manufacturer in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility. Unfortunately, the 3T devices manufactured at this facility were distributed worldwide.
The FDA concluded this information with the following set of warnings for doctors and hospitals using the 3T system:
If your facility uses 3T devices, you should:
- 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.
- Use new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device.Direct and channel the heater-cooler exhaust away from the patient, e.g., to the operating room exhaust vent.
- Be aware that device contamination also may occur from other sources such as environmental contamination or device contact with contaminated accessories.
- Review the recommendations in CDC’s Health Advisory
- Be aware that heater-cooler devices are important in patient care. In appropriately selected patients, the benefits of temperature control during open chest cardiothoracic procedures generally outweigh the risk of infection transmission associated with the use of these devices.
If your facility has 3T devices manufactured prior to September 2014, you should:
- Strongly consider transitioning away from the use of these devices for open-chest cardiac surgery until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection.
- Use of these devices should be limited to emergent and/or life-threatening situations if no other heater-cooler devices are available.
- Follow the FDA’s earlier recommendations to help mitigate the risks of patient infection.
- Be aware that testing of heater cooler devices to identify units contaminated with M. chimaera presents technical challenges related to sample collection, the long culture time, and the high rate of false negative tests. Therefore, it is not recommended at this time.
Stockert 3T Heater-Cooler In Review
It is estimated that numerous men and women have contracted NTM infections due to M. chimaera bacteria, as a result of contaminated Stockert 3T heater-cooler machines used during heart surgery. These people have often undergone painful, frustrating roads to recovery due to misdiagnoses and false-negative test results and some have died as a result of the contaminated product. The 3T product is used in close to 60% of all open heart surgeries in America. Patients across America who have been diagnosed with NTM infections, have begun to file lawsuits against LivaNova PLC. These lawsuits claim that the device giant did not take adequate steps to protect patients. At Johnson // Becker we believe that this is unfortunately another case of a medical device manufacturer putting profits over people.
- NTM Symptoms – “NTM Symptoms.” National Jewish Health. N. p., 2017. Web. 23 Feb. 2018.
- FDA’s Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices – “FDA’s Ongoing Investigation Of Nontuberculous Mycobacteria Infections Associated With Heater-Cooler Devices.” Fda.gov. N. p., 2018. Web. 23 Feb. 2018.
- Heater-Cooler Devices: Information for Health Care Providers and Staff at Health Care Facilities – “Heater-Cooler Devices: Information For Health Care Providers And Staff At Health Care Facilities.” Fda.gov. N. p., 2018. Web. 23 Feb. 2018.
- Heater-Cooler Devices: Information for Patients – “Heater-Cooler Devices: Information For Patients.” Fda.gov. N. p., 2018. Web. 13 Apr. 2018.
- Class 2 Device Recall STOCKERT HEATERCOOLER SYSTEM 3T – “Class 2 Device Recall STOCKERT HEATERCOOLER SYSTEM 3T .” Accessdata.fda.gov. N. p., 2018. Web. 13 Apr. 2018.
- Contaminated Heater-Cooler Devices – “Contaminated Heater-Cooler Devices | HAI | CDC.” Cdc.gov. N. p., 2018. Web. 13 Apr. 2018.
Frequently Asked Questions
Do I qualify to participate in the Stockert Lawsuit? If you had open heart surgery and have been diagnosed with an infection, we would like to speak with you. Most of our clients have been diagnosed with nontuberculous mycobacteria (NTM) or M. chimaera infections. However, sometimes they are diagnosed with mycobacteria or mycobacterium avium complex (MAC). In order to properly evaluate your the merits of your potential case, we need to speak with you about the details. We offer a free case review / consultation and would be honored to speak with you, so please give us a call.
Does it cost me money to file a lawsuit or be represented by your law firm? No. Our law firm offers a FREE review of your potential case. We work on a contingency fee basis, meaning that we do not get paid unless you receive compensation for your injuries.
Is Johnson // Becker filing Stockert 3T heater-cooler class action lawsuits? No. We believe that it is in our clients’ best interest to file their own lawsuit so that they can seek compensation for their own individual damages. We are filing Stockert 3T heater-cooler, M. chimaera lawsuits in both federal and state courts around the country.
Has there been a Stockert 3T heater-cooler recall? Yes. LinaNova acknowledged the potential for NTM, MAC and M. chimaera infections by issuing a Class II recall of the defective device. According to the Stockert 3T recall notice, “Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.”
Did you see a Stockert 3T heater-cooler television ad? If you recently saw a tv advertisement for the Stockert lawsuit, we are glad you found our law firm. We hope this page has given you the information you were looking for. If not, please let us know and we would be happy to answer your questions about the M. chimaera or nontuberculous mycobacteria lawsuits.
Has there been a settlement in these lawsuits? To date, there have not been any publicly available Stockert 3T settlements.