A South Carolina medical malpractice lawsuit filed on January 8, 2024 alleges, in part:
On March 15, 2019, Markeith Gerald had a LVAD [left ventricular assist device] placed at MUSC) [Medical University of South Carolina]. A Sorin 3T device was used during this procedure. Per the MUSC records, medical staff treating Mr. Gerald diagnosed him with a Mycobacterium chimaera (“M. chimaera”) infection after his heart transplant surgery in September of 2021 when the LVAD was removed and biopsies were conducted.
Plaintiff was not informed that her husband’s 2019 surgery involved a heater-cooler device that infected him with M. chimaera until a conversation she had with MUSC’s infectious disease physician, Dr. Scott Curry, on March 8, 2022.
MUSC then officially notified Plaintiff that her husband was exposed to M. chimaera during his LVAD surgery via a letter dated July 18, 2022.
Mr. Gerald died on August 16, 2022. His autopsy concluded the cause of death was “complications of disseminated mycobacterial chimaera infection following heart transplant due to chronic mycobacterial infection of left ventricular assist device.”
Mycobacterium chimaera is a water-born pathogen that can, and does, harbor and colonize in places utilizing less than sterile cleaning and preparation techniques. A rapid-growing mycobacterium, M. chimaera is closely identified with the bacteria that causes tuberculosis and leprosy.
Unbeknownst to Plaintiff at the time of Mr. Gerald’s March 2019 surgery, the MUSC facility did not have safe, sanitary, and sterile conditions. In fact, the MUSC facility harbored a deadly pathogen. Because the Sorin/LivaNova Defendants created a dangerous product and because MUSC failed to follow safety and sanitary guidelines, the pathogen was allowed to colonize, populate, and spread in certain medical equipment and locations, thereby posing a threat
to unsuspecting patients, including, but not limited to, Mr. Gerald.
More specifically, the heater-cooler unit being used by MUSC inside of the surgery suite was a Sorin 3T unit purchased from Sorin, a German company with a known history of selling these units contaminated with M. chimaera from the manufacturing plant in Germany and shipping the contaminated units to hospitals in the United States, including MUSC. Through this contaminated and defective equipment, the deadly pathogen was brought into the sterile operating field and directly into Mr. Gerald’s open heart cavity.
At the time of Mr. Gerald’s March 2019 surgery, several other cardiac/thoracic surgery patients around the country and here in South Carolina had been exposed to and infected with M. chimaera as a result of a contaminated surgical suite and/or contaminated Sorin 3T unit, and MUSC knew and/or should have known that exposing Mr. Gerald to these same dangerous and hazardous conditions would result in him developing a life-threatening M. chimaera infection.
In addition, the operating suite where Mr. Gerald’s surgery was performed, upon information and belief, utilized non-sterile tap water in certain pieces of equipment, which water possibly contained M. chimaera.
Despite the clear evidence and symptoms reported and observed by MUSC doctors and staff, and MUSC’s knowledge and understanding of the prior infections by patients who had undergone cardiac thoracic surgery in a contaminated surgical suite and/or with a contaminated Sorin 3T unit, MUSC failed to properly diagnose and treat Mr. Gerald’s M. chimaera infection. Instead, MUSC, its doctors, and staff required Mr. Gerald to undergo additional, unnecessary, and
invasive open-heart surgery and treatments that failed to properly treat or eradicate the M. chimaera infection, and which caused Mr. Gerald to sustain severe pain and suffering, damages to his heart and internal organs, as well as a significantly shortened life expectancy.
Although this scenario could have been eliminated in multiple ways, including, without limitation, by not placing a defective product into the stream of commerce, by following proper maintenance techniques and protocols to maintain a safe, sanitary, and sterile surgical suite, by preventing the infiltration of deadly pathogens therein from the contaminated Sorin 3T unit, and/or by warning Plaintiff of the known contaminated, unsafe, and unsanitary conditions, thereby allowing him to choose another hospital facility in which to undergo cardiac surgery, none were followed by the Defendants. Over time, Mr. Gerald became seriously ill and injured, and as a result of being infected with M. chimaera, he was required to undergo an unnecessary surgery with requisite pain and suffering that continued for the duration of his natural life.
Mr. Gerald died on August 16, 2022.
In addition to Mr. Gerald, numerous other patients at MUSC were infected with M. chimaera in the same way. Because of the negligence described herein, the lives of all the people now infected with this pathogen have been changed forever.
If you or a loved one suffered serious harm (or worse) as a result of a defective medical device in South Carolina or in another U.S. state, you should promptly find a defective medical device lawyer in your state who may investigate your medical device claim for you and represent you or your loved one in a defective medical device case, if appropriate.
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