A couple has filed an open heart surgery lawsuit soon after discovering that the device may have been contaminated during its manufacturing stages.

Plaintiff couple Kathy T. and James T. are filing this open heart surgery lawsuit together, claiming Kathy developed life-threatening bacterial infection soon after her procedure.

Kathy underwent open heart surgery to treat an intramural hematoma on Nov. 29, 2015. During the surgery, her surgeons utilized the Sorin 3T heater-cooler device to stabilize her body temperature. In early 2016, Kathy received a warning letter dated Feb. 01, 2016 from the hospital of her surgery stating that she may be at risk of non-tuberculosis mycobacteria (NTM, or M. chimaera) infection due to the use of the heater-cooler device during her surgery.

Overview of Open Heart Surgery Lawsuit

The University of Iowa Hospitals and Clinics (UIHC) announced that 1500 patients who underwent major heart, lung, and liver surgeries between Jan. 1, 2012 and Jan. 22, 2016 may be at risk for potentially fatal bacterial infections.

UIHC explained that the Sorin 3T heater-cooler systems may have been contaminated with a deadly bacteria and advised patients to follow up with their physicians. Soon after receiving the letter, Kathy allegedly began experiencing vision changes and temporary eyesight loss in both eyes.

Additionally, Kathy began experiencing pain and large floaters in both eyes. Kathy allegedly began experiencing additional symptoms in November 2016 which included:

• Night Sweats
• Nausea
• Fatigue
• Joint and Muscle Pain
• Chest Pain
• Decreased Appetite
• Weight Loss
• Shortness of Breath

These symptoms reflected the same side effects associated with potential M. chimaera bacterial infections as described by the CDC, as well as the warning letter sent from Kathy’s hospital. After consulting her physician and ophthalmologist, it was confirmed that Kathy could be suffering from potential M. chimaera bacterial infection.

On April 27, 2017, Kathy was officially diagnosed with NTM infection after physicians discovered the infection in several parts of her aorta. Kathy underwent extensive surgery to replace the aortic roots, as well as reconstructing the right and left main coronary artery.

However, during this procedure, Kathy reportedly suffered hemorrhagic shock and other complications that ultimately compounded. The lawsuit states, that to this day Kathy is contending with her M. chimaera bacterial infection and will most likely to have to continue antibiotic treatment for the next 12 to 18 months.

Kathy and her husband filed the open heart surgery lawsuit against Sorin, alleging the company either knew or should have known about potential NTM infection. According to the lawsuit, the FDA and CDC have been concerned about potential NTM bacterial infections since September 2014, when samples showed contamination at the manufacturing plant in Germany.  Even though this issue was resolved in July 2015, the FDA stated devices manufactured before 2014 could potentially induce deadly NTM bacterial infections in patients.

The Open Heart Surgery Lawsuit is Case No. 4:17-cv-00360-JAJ-SBJ, in the U.S. District Court for the Southern District of Iowa.