Lawsuit Charges Pentax Negligence Led to Fatal Superbug Infection

September 1, 2015

Lexi J. Hazam of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that the adult children of Renate Winkler as administrators of her estate have filed a wrongful death lawsuit against Pentax Medical, a division of Pentax of America, Inc., and Advocate Lutheran General Hospital, which is located in the Chicago suburb of Park Ridge, Illinois. Ms. Winkler died on December 7, 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.

Superbug victim Renate Winkler

Renate Winkler died at age 82 and was a resident of Mt. Prospect, Illinois

“No other families should have to go through what we did with the tragic death of our mother from CRE after an ERCP,” stated plaintiff Ronald Winkler. “No patient should have to suffer from a terrible infection as a result of a standard medical procedure like our mother did. If proper safety measures had been taken by the hospital and Pentax, the infection and her death would have been prevented. We hope to raise awareness among doctors and patients so that this does not happen again.”

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 Hazam. “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 yesterday, August 31, 2015, in state court in Cook County, Illinois. Ms. Winkler was a resident of Illinois.

Source: Lieff Cabraser Heimann & Bernstein, LLP