Kirtland & Packard LLP is currently taking cases where patients who have had open-heart or chest surgery and developed non-tuberculous mycobacterial infections afterward as a result of the Sorin Stockert 3T heater-cooler system. Patients suffering from these complications may have cause to pursue litigation, and Kirtland & Packard would be honored to fight on your behalf.
The Sorin Stockert 3T heater-cooler system is designed to raise or lower the temperature of a patient, based on warming or cooling blood that is being circulated through a heart-lung machine used during cardiopulmonary bypass. Heater-cooler devices are intended for use in patients undergoing surgery involving cardiopulmonary bypass lasting six hours or less.
In 2015, the FDA issued a national safety communication regarding heater-cooler devices, which have been linked to dozens of nontuberculous mycobacterial (NTM) infections in patients. The FDA issued an additional safety communication in June 2016 specifically noting Sorin’s Stockert 3T heater-cooler system had been directly implicated in the development of NTM infections in patients who had undergone open-chest cardiac surgery.
On October 13, 2016, in an update to its June 1, 2016, Safety Communication, the FDA provided additional information regarding Mycobacterium chimaera (M. chimaera) infections occurring in patients who had cardiothoracic surgeries in which the Stockert 3T Heater-Cooler System (3T) was used to warm or cool their blood. Of particular importance, the update supplies recommendations for health care professionals to assist in prevention of the spread of infection related to this heater-cooler device.
The FDA has also issued warning letters to Sorin regarding its heater-cooler devices being adulterated, “in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements. …” Among the problems stated in one warning letter, the FDA specifically mentions the company had received several complaints of patient deaths due to NTM infections “Where the cause of the infection appeared to be 3T devices colonized with the mycobacteria.”
Mycobacterium chimaera (M. chimaera), a type of nontuberculous mycobacteria linked to Sorin Stockert 3T heater-cooler devices can cause infections that at one hospital has carried a mortality rate of 50 percent in affected patients.
The FDA wrote in its national safety communication intended for patients and healthcare providers: “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 or to aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.”
According to a brief prepared for an Advisory Committee held in June of 2016 discussing NTM infections associated with heater-cooler devices, the FDA noted it has received 61 medical device reports from around the world and within the U.S. in which patient infection was reported as potentially related to a heater-cooler device and 119 others in which device contamination was identified.
Infections linked to M. chimaera and other forms of nontuberculous mycobacteria are considered rare since the bacteria are typically benign and are typically found in soil or water. Unlike other cases of NTM infections, however, those that have been linked with heater-cooler devices, according to the FDA, “represent a very different epidemiological phenomenon” with “a more aggressive pathological profile.”
Because of its potentially lengthy latency period, NTM infection may be difficult to diagnose because it can take months to years after initial exposure to manifest, sometimes with lethal results.
On January 13, 2017, the Los Angeles Times newspaper reported that, “Pasadena’s Huntington Hospital has sent letters to all patients having open heart surgery in the last four years warning them that they may have been infected with a dangerous bacteria [as a result of the Sorin Stockert 3T heater-cooler system] ” and that, “More than 250,000 heart bypass procedures are performed using the heater-cooler devices each year in the U.S., according to the federal Centers for Disease Control. … About 60% of heart bypass procedures in the U.S. use the Sorin Stockert 3T heater-cooler device that has been linked to the bacteria.”
On February 1, 2017, the Los Angeles Times newspaper reported further that, “Los Angeles County health officials said Wednesday that at least three heart surgery patients at a hospital have been sickened by a dangerous bacteria linked to an operating room device [the Sorin Stockert 3T heater-cooler system]”, and “[Los Angeles County] has asked all 24 hospitals using the Sorin heater-cooler to look for possible infections. Some hospitals have now switched to heater-coolers manufactured by other companies … Officials have advised those continuing to use the device to inform patients before their surgery that they are using a device linked to infections.”
As details of the infections become more widespread, a handful of patients have begun to seek compensation by pursuing civil suits against Sorin, which makes the Stockert 3T heater-cooler system, with more expected to be pursued in the future.
For more information or to schedule a free consultation, please call Kirtland & Packard at (855) 711-4933.