LAWSUIT FILED AGAINST PENN
HEALTH SYSTEM AND OTHERS IN WHICH FORMER SURGICAL PATIENT CLAIMS
USE OF DEFECTIVE HEATER-COOLER UNIT LED TO LIFE-THREATENING
Philadelphia, PA (April 19, 2017) - Attorneys at Saltz,
Mongeluzzi, Barrett & Bendesky, P.C., have filed a Complaint on
behalf of Robert Gerngross, an electrical engineer-contractor, who
acquired a potentially lethal bacterial infection (Non-tuberculous
Mycobacterium, NTM) following open-chest surgery in February, 2015
at Penn Presbyterian Medical Center. His Complaint filed today
asserts that the health system, and the manufacturer of the Sorin
3T Heater-Cooler Device (HCD), should never have allowed its use
because they knew, or should have known, the controversial
surgical-support unit posed a high risk for patient infection.
SMBB attorneys Robert J. Mongeluzzi, Michael F. Barrett and Mary
T. Gidaro represent Mr. Gerngross, 60, of suburban Philadelphia,
who has been unable to resume his work as a result of the
post-surgical complications and his continuing related medical
care. Mr. Gerngross gradually became so sick following his initial
surgery to implant a mechanical heart valve that the infected valve
had to be removed and replaced. After the replacement surgery on
December 6, 2016, it was determined that the original mechanical
valve tested positive for NTM.
The SMBB attorneys filed the Complaint (in January they began
litigation and pre-trial discovery with a Writ of Summons) after
obtaining from Penn's attorneys numerous patient treatment records.
Those records were helpful in identifying the Sorin 3T HCD (Model
No. 16-02-85), and led to naming LivaNova PLC, the parent company
of the Sorin Group, as co-defendants in the eight-count Complaint
filed in Philadelphia Court of Common Pleas (CCP PhilaCo.
January Term 2017, No. 01914). It includes claims for compensatory
and punitive damages.
"Bob Gerngross and his family should have been
told well before his first surgery that the HCD posed a potential
danger," said Mr. Barrett. "There is no reasonable explanation, no
excuse, for the hospital's failure to notify Mr. Gerngross and
other patients of the risks associated with that device until
September 2016, by which time it was too late." He added, "As
detailed in the Complaint, Penn missed multiple opportunities to
identify and treat infections linked to the Sorin HCD."
As for the device manufacturer's role, Mr.
Mongeluzzi noted, "There was a total failure of corporate
responsibility to the patients who put their trust in that device.
It was well established that the bacteria, which is resistant to
many antibiotics, came from one particular Sorin (German)
manufacturing site. The defects in its HCD allowed bacterial
colonization to which patients like Mr. Gerngross could be, and
were in fact, exposed to during heart surgery, thus posing a
significant risk of bodily injury."
Ms. Gidaro said Mr. Gerngross and his wife (they
have a young son, and he has two older children by a previous
marriage) brought the action to raise awareness in hopes that it
might help prevent other tragedies regarding hospital-surgical
acquired infections. "As an engineer, he was shocked to learn that
documents regarding the HCD did not even include detailed
instructions on disinfecting the unit's water tank." The attorney
noted that after intervention by regulatory authorities, Sorin
"enhanced" its recommended cleaning procedures from six to 56
steps. Heater-cooler units are used during surgery, working in
conjunction with heart-lung machines, to control the temperature of
the patient's blood and organs.
Michael F. Barrett / email@example.com
Note: FDA recall link