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The manufacturers of the 3T Heater-Cooler System, which is commonly used during open heart surgery to control blood temperature, face a class action lawsuit over the risk of nontuberculous mycobacterium (NTM) infections following heart surgery, which may surface years after exposure to contaminated devices.
Jeri Pickrell filed the complaint (PDF) against Sorin Group and Livanova PLC in the U.S. District Court for the District of Iowa on May 31, seeking class action status for all individuals in Iowa who were “unknowingly exposed to a potentially fatal bacteria during open heart surgery.”
Heart surgery infections have been linked to Sorin 3T Heater-Coolers, which are commonly used during bypass surgery, valve replacement surgery and other cardiac procedures. The devices involve the use of tanks that provide temperature controlled water used to regulate blood temperature. However, last year it was discovered that many devices manufactured prior to September 2014 may be contaminated with a slow growing bacteria, which can cause life-threatening infections to surface months or even years after exposure.
Contaminated vapors may be released by the 3T Heater-Cooler, posing a serious risk for individuals with a compromised immune system and open chest cavity during the surgery, leading to multiple reports of Mycobacterium chimaera infections, Mycobacterium abscessus infections or other NTM infections, which can lie dormant for months or even years before symptoms become obvious.
At least two hospitals in Iowa have warned patients who underwent major heart surgery or other procedures between January 1, 2012 and July 1, 2016 that they may have been exposed to the rare and potentially fatal bacteria through a 3T Heater-Cooler. Similar hospital letters about the NTM infection risk have been sent by other facilities nationwide, warning individuals to follow up with their physician.
“Symptoms of an NTM infection are very general and may include any combination of the following: fever, pain, redness, heat or pus around a surgical incision, night sweats, joint pain, muscle pain and fatigue,” according to the complaint. “Because NTM symptoms are non-specific and manifestation may take several weeks to several years, a patient will most likely fail to link the infection to his or her prior heart surgery, particularly as more time elapses between surgery and initial symptomology.”
The 3T Heater-Cooler class action lawsuit seeks medical monitoring of patients who may be at risk of NTM infections during surgical procedures involving 3T systems, also calling for the court to declare that the systems as defective and unsafe for their intended use.
“NTM infections are capable of early detection by way of existing scientific methods including, but not limited to, targeted culturing and DNA sequencing of invasive samples (e.g. blood, pus, tissue biopsy or implanted prosthetic material),” the lawsuit states. “Because NTM screening is not conducted in the absence of exposure to NTM, the prescribed monitoring regime is different than that normally recommended in the absence of exposure. Plaintiff and Class Members require specialized screening not within the purview of routine medical exams.”
3T Heater Cooler System Infection Risks
Concerns about the heater-cooler infection risk following heart surgeries first emerged in October 2015, when the FDA issued warnings about a large number of adverse event reports received in connection with blood heater-cooler devices.
In June 2016, a panel of experts were convened to evaluated the issue, indicating that at least 34 reports involving NTM infections following heart surgery where heater-cooler systems were used.
Late last year, the federal regulators issued a safety communication warning about contaminated 3T Heater-Coolers, indicating that water tanks used by the devices may spread contaminants to other parts of the system, where they can be released into the air of the operating room.
“If allowed within the operative field, NTM poses a significant health risk to surgical patients and patients with compromised immune systems,” the lawsuit filed by Waddell states. “Because NTM is a slow growing bacterium, it generally takes anywhere from two weeks to four years before manifestation of an NTM infection, which most commonly results in pulmonary or cardiovascular disease.”
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of NTM infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.
The class action claim comes amid a growing number of individual 3T Heater Cooler System infection lawsuits by plaintiffs who actually developed infections following procedures. As additional infections continue to surface in the coming months and years, the number of cases is expected to continue to grow, potentially involving hundreds of claims.