Lieff Cabraser Heimann and Bernstein, LLP, announced that the adult children of Renate Winkler filed a wrongful death lawsuit against Pentax Medical, a division of Pentax of America, Inc., and Advocate Lutheran General Hospital, located in Park Ridge, Ill.
Winkler died on Dec. 3, 2013, from carbapenem-resistant Enterobacteriaceae or CRE, a bacteria that is highly resistant to antibiotics, following Endoscopic Retrograde Cholangiopancreatography or ERCP at Advocate Lutheran General Hospital. For the procedure, the hospital used a duodenoscope manufactured and sold by Pentax Medical.
The complaint charges that the Pentax Medical duodenoscope was defectively designed, resulting in certain parts of the instrument being extremely difficult to access for cleaning and sterilization. The complaint further charges that Advocate Lutheran General Hospital breached its duty of care by failing to properly clean and sterilize its duodenoscopes, thereby spreading deadly superbug CRE infections between patients. Approximately 43 other patients at Advocate Lutheran General Hospital were infected with CRE as a result of the use of contaminated Pentax duodenoscopes, the complaint alleges.
“As a medical device manufacturer, Pentax has an obligation to develop, test, and validate the safety of its products prior to selling them. Had Pentax done this, we believe it would not have sold duodenoscopes that were defective and unreasonably dangerous,” stated Lexi J. Hazam, of Lieff Cabraser Heimann and Bernstein. “Likewise, Advocate Lutheran General Hospital shares in the legal responsibility for the devastating impact of the CRE infection Ms. Winkler contracted. Contamination with CRE of a medical instrument used upon a patient in a hospital does not ordinarily happen in the absence of negligence, the suit charges.”
In an ERCP procedure, the duodenoscope is inserted through the mouth and into the stomach and upper part of the small intestine, the duodenum. It is used to visualize and treat certain problems of the biliary and pancreatic duct systems, such as gallstones.
The lawsuit was filed Aug. 31, 2015, in state court in Cook County, Illinois. Ms. Winkler was a resident of Illinois.