PHILADELPHIA, June 7, 2017 /PRNewswire/ -- Marisa Karamanoogian, a Delanco, N.J. school board member, knows her life will never be the same, but wants others to learn from her ordeal and avoid the excruciating pain and suffering she has endured since contracting a potentially lethal bacterial infection following her 2016 heart surgery at the Hospital of the University of Pennsylvania (HUP).
Through her lawyers at Saltz, Mongeluzzi, Barrett & Bendesky, P.C., Ms. Karamanoogian, 39, and her husband today filed an eight-count Complaint (CCP PhilaCo., January Term 2017, No. 01912) to hold all those responsible, including the hospital, its affiliates, and the companies that designed, manufactured and marketed the Terumo HX2 Temperature Management Heater-Cooler Device (HCD) linked to her devastating bacterial infection (Mycobacterium abscessus, a type of nontuberculous mycobacteria (NTM))
Several years before her surgery, U.S. and overseas health agencies warned about potentially life-altering injuries – even deaths – related to the use of the defective Terumo HX2 and similar devices. Surgical teams used those units to control the temperature of the patient's blood and organs. Investigators, including those at the U.S. Food & Drug Administration (FDA), determined that water-borne bacteria could form in the device and then be released in aerosol form through its exhaust system into the operating room, finding its way into the patient's open chest.
Michael F. Barrett, of SMBB, said the lawsuit contains significant new details obtained after the firm began the litigation process in January. "Pre-Complaint discovery enabled us to pinpoint the type of HCD used by our client's medical team, and to establish that there were early warning signs – that went ignored – indicating use of that HCD could lead to serious infection and injuries. Our client had no idea what she was in for, but the defendants had every reason to believe that she could be a prime candidate for a post-surgical catastrophe."
Robert J. Mongeluzzi, Mr. Barrett's partner, stated, "We aim to establish at trial why Terumo – an international medical device manufacturer - failed to take the steps necessary to make its product safe, and persisted to promote it as safe and effective despite rampant red flags from regulators."
Mary T. Gidaro, of the SMBB legal team, added, "Marisa, the mother of three, required four corrective surgeries after the infection was determined, and is unlikely to ever know what it is like to be pain free. In addition, she suffers permanent partial hearing loss as a result of an adverse reaction to one of the many antibiotics she was prescribed."
"As a patient, I put my trust and confidence in the medical professionals and their equipment," said Ms. Karamanoogian. "Everyone and everything failed me and my family, and I can only hope that by taking action what happened to me can never happen again, to anyone, anywhere."
According to the Complaint, "Despite knowledge of the design defect of HCDs and NTM contamination of HCDs, and despite knowledge of the catastrophic injuries, conditions, complications, infections, and/or deaths caused by the use of HCDs during open heart surgery, the Terumo Defendants continued to manufacture, market, advertise, sell, and/or deliver its Terumo HCD to hospitals" including HUP.
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SOURCE Saltz, Mongeluzzi, Barrett & Bendesky, P.C.