Products Liability
Surgical Heater-Cooler Infection Lawsuits
Around February 2018, the Judicial Panel on Multidistrict Litigation consolidated about 40 lawsuits against medical device company LivaNova over injuries allegedly caused by their Sorin 3T heater-cooler system. The Sorin 3T heater-cooler systems are widely used during surgery to maintain the patient’s body temperature. The product liability lawsuits allege that the Sorin 3T units have a major design defect that causes them to stimulate the growth and spread of bacteria on patients during surgical procedures involving an open chest cavity. This includes all types of heart and cardiovascular surgeries which are the most common type of surgical procedures, meaning Sorin 3T defect has the potential to affect hundreds of thousands of people. The problem with the Sorin 3T has allegedly resulted in very serious types of bacterial infections such as Nontuberculosis Mycobacteria (NTM).
What are Surgical Heater-Cooler Devices?
Body temperature fluctuation is often a major problem during surgeries in which the chest and certain other parts of the body must remain open for prolonged time periods. Surgical heater-cooler devices like the Sorin 3T are designed to address this issues by mechanically regulating a patient’s temperature during a surgical procedure. They are primarily used in cardiothoracic and similar types of heart surgeries, but can also be used in various operations where body temperature is hard to control. Heater-cooler systems consist of special tanks that transfer temperature-regulated water to either external heat exchangers or warming/cooling blankets via closed circuits.
Problems With the Sorin 3T and Bacterial Infections
The problem with the Sorin 3T heater-cooler devices is that a large number of them may actually be contaminated and cause patients to develop nontuberculous mycobacterium infections which are a very serious type of bacterial infection. Most the infections related to the heater-cooler system involve the bacteria named Mycobacterium Chimaera (M. chimaera), a species of Nontuberculosis Mycobacterium (NTM). NTMs are a unique species of mycobacteria that are not part of the Mycobacterium tuberculosis complex, which can cause tuberculosis in humans and other animals. NTMs can be found throughout the environment, especially in water and soil. Mycobacterium Chimaera-related illnesses are rare, but they sometimes occur in patients who have undergone invasive procedures or people with weakened immune systems.
Theses bacteria have a tendency to grow on the outside of the coolant or water tanks of the Sorin heater-cooling systems. The water inside the tanks themselves, which circulates to the patient, is not actually contaminated so there is no direct contact with the blood or body fluids of the patient. What happens is the bacteria grow on the damp outside surface of the tanks. When in use condensation forms on the tanks and these water droplets then aerosolize in the operating room. When these occurs the contaminated water becomes airborne and it can easily invade an open body cavity or sterile device that and thereby cause infection in the patient.
Symptoms
Most species of NTM that are found in heater-coolers grow slowly. An infection can take between several months and over a year to develop. Symptoms include fatigue, fever, pain, redness, muscle and joint pain, night sweats, weight loss, abdominal pain, nausea, and vomiting.
Ask your doctor about what kinds of risks and benefits of the procedure. The benefits usually outweigh the infection risk. You should ask your doctor what may happen after your surgery and when you should seek medical attention. If you experience symptoms, contact your doctor or other health care provider immediately. Let them know about the procedure you had which you think resulted in your symptoms. Contact the CDC as well.
Treatment Options
Various combinations of antibiotics are effectively used to treat NTM infections. Some patients may need to be treated longer for the bacteria to go away. While rare, some patients who underwent heart valve surgery may need to undergo more surgery to stop the spread of infection inside the body. NTM infections may be fatal if left undiagnosed and untreated.
FDA Reports
The FDA began receiving reports on NTM infections related to heater-cooler devices such as the Sorin 3T around 2010. They received over 30 Medical Device Reports (MDRs) pertaining to this specific issue. More than three-quarters of these MDRs were reported in 2015.
Many alerts have been issued by the FDA and CDC about the NTM infections being caused by these heater-cooler devices. Around October 2016, the CDC warned healthcare providers and patients about the infection risk from heater-coolers.
Lawsuit
Several lawsuits have been filed against LivaNova, the current manufacturer of the 3T heater-cooler devices originally developed and sold by Sorin. The lawsuits allege that the improper design and manufacture of the 3T heater-cooler devices made them defective and dangerous and resulted in the bacterial contamination of the patients. As of February 2018. A federal MDL panel consolidated 39 of them during the same month into an MDL – which is like a class action for pre-trial discovery — that would be handled by a Federal Court judge based in Pennsylvania.
Contact Miller & Zois About Sorin 3T Heater-Cooler Lawsuits
Miller & Zois is currently seeking new cases involving bacterial infections caused by the use of Sorin 3T heater-cooler devices during open heart surgery. If you have a potential case call us at 800-553-8082 or contact us online.