The family of a Renate Winkler, who died due to a “superbug” infection transmitted by a duodenoscope, said Tuesday they are suing both the treating hospital and Pentax Medical, who manufactured the scope, for wrongful death.
Winkler died from a carbapenem-resistent enterobacteriacea infection, which is highly resistant to antibiotics, following an endoscopic retrograde choloangiopancreatography procedure at the Advocate Lutheran General hospital, according to the law firm Lieff Cabraser Heimann & Bernstein.
“No other families should have to go through what we did with the tragic death of our mother from CRE after an ERCP. 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,” plaintiff Ronald Winkler said in prepared remarks.
The suit charges that the duodenoscope from Pentax was “defectively designed, resulting in certain parts of the instrument being extremely difficult to access for cleaning and sterilization,” according to the firm.
“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,” partner Lexi Hazam said in a press release.
The firm said the hospital was responsible for a breached duty of care by failing to clean and sterilize the scope and spread the bug, which infected approximately 43 other patients at the hospital as well.
“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,” Hazam said.
The suit was filed August 31st in Cook County, Illinois, where Ms. Winkler resided.