LAWSUIT FILED AGAINST PENN HEALTH SYSTEM AND OTHERS IN WHICH FORMER SURGICAL PATIENT CLAIMS USE OF DEFECTIVE HEATER-COOLER UNIT LED TO LIFE-THREATENING BACTERIAL INFECTION

SMBB
April 19, 2017

LAWSUIT FILED AGAINST PENN HEALTH SYSTEM AND OTHERS IN WHICH FORMER SURGICAL PATIENT CLAIMS USE OF DEFECTIVE HEATER-COOLER UNIT LED TO LIFE-THREATENING BACTERIAL INFECTION

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.

Contacts:

Michael F. Barrett / mfbarrett@smbb.com

215.496.8282

 

Note: FDA recall link

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150831

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