Mycobacteria Infection Lawsuits for Heart Surgery Patients

Attorneys working with ClassAction.org are speaking with patients who underwent heart or lung surgery and were later diagnosed with a non-tuberculous mycobacteria (NTM) infection. A medical device used in some of these procedures – known as a “heater-cooler” – is currently under investigation by the FDA after reports surfaced that it can spread bacteria during surgery and cause infections and possibly death. One popular heater-cooler, the Sorin 3T, has been the center of dozens of lawsuits from patients who say they were infected because of defects in the device.  

If you or a loved one underwent open heart or lung surgery and was diagnosed with a non-tuberculous mycobacteria infection, you may be able to file a lawsuit to collect money for medical bills and physical suffering.

How Would I Know if a Heater-Cooler Was Used During My Surgery?

Most patients are probably unaware as to whether a heater-cooler system was used during their surgery; however, procedures where these systems are typically used include:

According to the FDA, NTM infections appear to be developing most frequently in patients undergoing “open chest” surgeries and who are also receiving an implanted device, such as a vascular graft or heart valve. NTM infections typically won’t manifest symptoms, which include fever and heat/redness at the surgical site, until several months to a year or more after the surgery. If you underwent heart or lung surgery and were later diagnosed with NTM infection, it’s possible that a heater-cooler was used during your procedure and may be responsible for your illness.

How Can a Lawsuit Help Me?

A lawsuit can provide you the opportunity to sue the manufacturer of the heater-cooler device for your medical expenses, as well as compensation for physical and mental suffering. You may also be able to collect money for lost wages if you had to miss work in connection with your NTM infection and its treatment. Family members may also be entitled to money for loss of projected earnings and funeral expense in the case of a fatal infection.

Is This a Class Action Lawsuit?

No. Lawsuits involving heater-cooler devices are being filed on an individual basis. This means that you will need to file your own lawsuit with your own attorney if you developed an infection; there is no class action lawsuit that will cover you for your injuries. You can read more here about why most lawsuits involving medical devices typically aren’t filed as class actions.

Heater-Cooler Systems Under Investigation for Link to NTM Infections

The FDA has announced that it is continuing to investigate reports of non-tuberculous mycobacteria infections associated with heater-cooler devices. These devices are used during cardiothoracic surgeries to warm up or cool down a patient and contain a water tank, where it is believed non-tuberculous mycobacteria, including mycobacterium chimaera, can grow.

The FDA has cautioned that water in these tanks can evaporate and enter the air during the procedure. Because non-tuberculous mycobacteria can be released into the air by the heater-cooler system, the patient could become infected through his or her open chest wound. 

Sorin Group USA Inc. is already facing at least 80 lawsuits over its Sorin 3T heater-coolers, and several other devices – some of which have been subject to FDA recalls – are also under investigation by attorneys for their possible link to NTM infections. These additional heater-cooler systems include:

Lawsuits filed over the Sorin 3T argue that the device’s design and manufacturing made it susceptible to “bacterial colonization” of mycobacteria despite cleaning and disinfection procedures. The suits further claim that the manufacturer under-reported and withheld information about the performance of its heater-cooler and misrepresented the device’s safety and efficacy, “misleading the FDA, the medical community, patients, and the public at large.” The suits claim that as a result, numerous patients have suffered severe injuries and complications following surgery. 

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