ST. LOUIS – A man who suffered a bacterial infection when he underwent heart surgery in 2016 recently filed a lawsuit against the medical device manufacturers whose equipment was used during his procedure claiming he suffers from night sweats, fevers, weakness, pain, discomfort, impairment and loss of enjoyment of life.
In the suit filed June 28 in the U.S. District Court for the Eastern District of Missouri, Benjamin Haupt and his wife, Maggie Haupt, of Jefferson County take aim at England-based LivaNova PLC, Germany based LivaNova Deutschland GmbH and LivaNova Holding USA Inc. over the design, manufacture and marketing of their Sorin 3T Heater-Cooler System (3T System).
The 3T machine is used for cardiothoracic surgeries, and according to the lawsuit, it regulates blood temperature by circulating water through tubes into a heat exchanger where blood is pumped into separate chambers during surgery. The water tanks and other areas where water passes through aerosolize a vapor containing non-tuberculosis mycobacterium (NTM), which exits out of the device and is pushed into the ambient air of the operating room through the system’s exhaust fan. If placed in the operating room, contaminated vapor from the 3T System directly enters the sterile surgical field and the patient’s open body.
About six months after Haupt's surgery on June 1, 2016, the FDA issued a safety communication to health care providers with information about non-tuberculosis infections associated with the use of 3T Systems in U.S. patients who had undergone cardiothoracic surgeries.
The bacterium at issue in Haupt's complaint, is named "M. Chimaera," a subspecies of NTM that occurs naturally in the environment and rarely causes illness. "However, M. Chimaera poses a unique risk to patients whose organs and chest cavities are directly exposed to the bacteria during surgery," the suit claims.
The Haupts' 10-count lawsuit claims the 3T system "colonizes" bacteria, specifically M. Chimaera, and that the foreseeable risks of using it "significantly outweigh the benefits."
They are represented by Amy Collignon Gunn of the Simon Law Firm in St. Louis.