Products Liability
Patients are filing lawsuits against an unlikely source after post-surgery infections. Last year, the Centers for Disease Control and Prevention (CDC) issued a communication advising hospitals and patients of the infection risk posed by Sorin Stöckert 3T heater-cooler devices.
In the press release, the CDC warned that these devices are exposing heart surgery patients to life-threatening Nontuberculous Mycobacteria (NTM) infections. Currently, the CDC is working to reduce the threat posed by heater-cooler systems and recommending that older 3T heater-coolers be replaced.
However, it’s important to understand that the symptoms of an NTM infection may take months or years to appear after surgery. If untreated, an NTM infection can result in painful medical complications and in some cases death.
What are 3T Heater-Cooler Systems?
These are machines used by hospitals to stabilize a patient’s body temperature, most often during open heart or open chest bypass surgery that has been on the market for 12 years. The devices send temperature-controlled water to blankets or heat exchangers, allowing the body to continue to circulate blood at a proper temperature. According to the CDC, more than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year. Over half of the heart bypass procedures performed in the U.S. use body temperature regulation devices such as the Sorin Stöckert 3T heater-cooler.
What does the 3T Heater-Cooler look like? It looks like this. Is a free-standing unit on wheels, that consists of cold and hot reservoirs of water. The water is circulated to and from the heart-lung machine via long plastic tubes or hoses that are connected to the heat exchanger of the heart-lung machine. The purpose of this medical device is to increase or decrease the temperature of the patient’s blood circulating through the heart-lung machine when the patient is on cardiopulmonary bypass. The hot and cold water from the Heater-Cooler is in a circuit completely separate from the circuit carrying the patient’s blood.
The Sorin Stöckert 3T heater-cooler is manufactured by LivaNova PLC, which was previously known as Sorin Group Deutschland GmbH. In 2015, LivaNova recalled the Sorin Stӧckert 3T heater-cooler systems because of their role in spreading life-threatening infections. It is also worth noting that the 3T took a shortcut to FDA approval under the theory that the 3T is substantially equivalent to an already legally-marketed device. It is crazy how many mass tort lawsuits stem from drugs and medical devices that went through this shortcut approval process.
The Risk of Infection
We now know that LivaNova’s heater-cooler units may contain water that is infected with mycobacterium chimaera (M. Chimaera) bacteria. When used, the machines can spread the bacteria throughout the room via vaporized water. Health officials ultimately discovered traces of M. Chimaera within some Sorin 3T heater-cooler devices as well as inside the German manufacturing plant where the units were built.
NTM targets the lungs, causing an inflammation of the respiratory system. If not treated, this will develop into a progressive lung condition. While infection from the M. Chimaera strain is rare, it is often seen in patients who suffer from other health conditions or who have implants such as artificial heart valves.
Thankfully, the likelihood of health issues stemming from this bacteria is low. It’s believed that only between 1 in 100 and 1 in 1,000 patients exposed to NTM through a heater-cooler will develop an infection. But although this is a small percentage, there have been at least 21 reported cases of infection in the U.S., resulting in six deaths. At present time, roughly 100 patients from around the globe have been identified with M. Chimaera infections that appeared after cardiac surgery.
Symptoms and Treatment
M. Chimaera is a slow-growing but severe strain of NTM that may not be diagnosed until well after surgery. It’s critical that you and your care providers recognize how important it is to monitor for signs of NTM in the months following your surgery. Symptoms of an infection usually include persistent fevers, shortness of breath, and sudden weight loss. Other signs include muscle or abdominal pain, vomiting/nausea, persistent cough, swelling at the surgery site, joint pain and night sweats.
This infection is mostly often treated with administered antibiotics. In some rare cases, M. Chimaera infection may require surgery.
Allegations in Lawsuits
The core of this case is that plaintiffs’ lawyers claim that the makes of this device knew, or should have known of the association of NTM infections with the use of their 3T Heater-Cooler when used in during heart surgery. The lawsuits allege that despite knowledge of the design defect and contaminated water supply used during the manufacture of their 3T Heater-Coolers, and despite knowledge of the catastrophic injuries, conditions, complications, infections, and/or deaths caused by the use of their 3T Heater-Coolers during open heart surgery in Europe since 2011 and elsewhere, the manufactures continued to sell this product without even informing doctors of the risk.
Nontuberculous Mycobacterium Class Action
There is currently a MDL class action lawsuit against LivaNova in Pennsylvania federal court made up of over a dozen 3T heater-cooler NTM claims from across the country. Allegations in the individual suits include claims that a design defect enabled the NTM bacteria to grow inside the water tanks, that LivaNova didn’t perform adequate safety tests on the device and that LivaNova failed to warn hospitals or patients of the potential infection risk. Below are several pending suits stemming from Sorin 3T heater-cooler infections.
- Massachusetts: A woman claims a Sorin heater-cooler was used during surgery to replace a heart valve. Her suit alleges that she sustained respiratory injuries from an NTM infection that developed after the procedure.
- South Dakota: A male patient alleges that he developed M. Chimaera after aortic valve replacement surgery where a Sorin unit was present. The suit alleges his condition was not diagnosed until nearly five months after the procedure.
- Iowa: The widow of a man who required open heart surgery alleged that a NTM bacterial infection caused her husband’s death. The suit claimed that a Sorin heater-cooler manufactured prior to 2014 was used by the hospital. According to the complaint, the patient was not diagnosed with NTM until two years after surgery.
This is just 3 of the 40 lawsuits that have been filed in 21 District Courts around the country.
Does Your Law Firm Handle These Claims?
Our firm is not handling 3T Heater Cooler claims. This litigation did not go very far.