Terumo Corp. (TYO:4543) and the University of Pennsylvania are facing a suit from a New Jersey woman who claims to have contracted a serious bacterial infection from a Terumo HX2 heater-cooler device during a heart surgery last year, according to a press release published yesterday.
Counsel for the plaintiff, Marisa Karamonoogian, said that her and her husband filed an 8-count complaint seeking to hold both Terumo and the University of Penn. responsible for a “potentially lethal” mycobacterium abscessus infection.
In the press release, lawyers for Karamonoogian reference earlier releases warning of such infections associated with heater-cooler devices and claim that operating physicians knew about the risk and ignored it.
“Marisa, the mother of 3, required 4 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 1 of the many antibiotics she was prescribed,” legal team member Mary Gidaro said in a press release.
Last month, Terumo launched the Miplate clinical trial of its Mirasol pathogen reduction technology system and enrolled the 1st patient in the study.
In the trial, Terumo will look to evaluate the effectiveness of Mirasol-treated apheresis platelets in plasma versus standard apheresis platelets in plasma, hoping that the data will support FDA premarket approval for the Mirasol PRT system.