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Penn Health System and the clinical practices of Penn Medicine are named in a civil lawsuit filed on behalf of two patients who were allegedly diagnosed with the same bacterial infection following open-heart surgery.
Attorneys in the case are trying to tie the bacterial infections to heater-cooler units used during surgery to control the temperature of the blood and organs, according to the law firm Saltz, Mongeluzzi, Barrett & Bendesky.
In court documents filed in a Philadelphia court on Jan. 13, the attorneys are asking for permission to move forward with a series of questions to the Hospitals of the University of Pennsylvania to pinpoint the type and manufacturer of the heater-cooler units that were used, and their operating and maintenance history.
The health system said it does not comment on pending litigation, said Susan Phillips, Penn Medicine's senior vice president for public affairs.
New Jersey school board member Marisa Karamanoogian, 39, and electrical engineer contractor Robert Gerngross, 60, of Pennsylvania, underwent open heart surgery about a year apart, according to their attorney Michael F. Barrett.
Both contracted a well known, and what the attorneys called potentially lethal bacterial infection, identified as nontuberculous mycobacterium, according to Barrett.
Karamanoogian underwent cardiac bypass surgery on Feb. 5, 2016, and was diagnosed with NTM about six weeks later after complaining of severe pain and fatigue, Barrett said. Several surgeries followed and she remains on a variety of IV-administered antibiotics.
Gerngross had aorta heart valve replacement surgery at Penn's Presbyterian Medical Center on Feb. 6, 2015. Fifteen months later he became symptomatic for NTM and was placed on IV antibiotics, his attorney said. In December, physicians replaced the mechanical heart valve and found the removed valve tested positive for NTM, Barrett said.
"We are asking the court to help us, on behalf of our clients, to fully determine exactly who was involved, their level of knowledge, what equipment they were using, and precisely how they could have exposed the patients to an infection that has now been traced to the deaths of at least six other open-heart surgical patients under what appear to be similar if not identical circumstances," Barrett said.
Government officials estimate more than 600,000 patients nationally may have been exposed to the infection strongly believed to be associated with the heater-cooler units used during surgery to control the temperature of the blood and organs, he said.
In October 2016, the Centers for Disease Control and Prevention issued a warning to healthcare providers and patients about the potential risk of infection from certain heater cooler devices used during open heart surgery.
Some LivaNova, formerly Sorin Group Deutschland GmbH, Stöckert 3T heater-cooler devices used during many of these surgeries might have been contaminated during manufacturing, which could put patients at risk for life-threatening infections, the CDC said.
Approximately 60 percent of heart bypass procedures performed in the Unites States use the devices that have been associated with these infections, the CDC said.
"While these infections can be severe, and some patients in this investigation have died, it is unclear whether the infection was a direct cause of death," the CDC said.