Suit Charges Negligence by Medical Device Manufacturer Pentax Medical and Chicago-Area Hospital Led to Patient Contracting Fatal Superbug Infection from Contaminated Medical Scope, Lieff Cabraser Announces

Photo of Renate Winkler, a resident of Mt. Prospect, Illinois, who died at age 82 from a superbug hospital-acquired infection allegedly due to a defective, contaminated medical scope manufactured and sold by Pentax Medical. (Photo: Business Wire)

CHICAGO--()--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 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.

“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.

Legal Resources For Patients And Their Families

Answers to common questions on the CRE superbug outbreaks, and legal resources for affected patients and their families, can be found at

If you or a family member developed CRE or another superbug following an endoscopic procedure, please complete the contact form at to contact an experienced injury lawyer at Lieff Cabraser to discuss your case. There is no charge or obligation for our review of your case.

About Lieff Cabraser

Recognized as "one of the nation's premier plaintiffs' firms" by The American Lawyer, Lieff Cabraser Heimann & Bernstein, LLP is a sixty-plus attorney law firm with offices in San Francisco, New York, and Nashville. Our firm has successfully represented thousands of patients across America in individual lawsuits due to the injuries they suffered from defective medical devices. U.S. News and Best Lawyers have named Lieff Cabraser as their 2015 "Law Firm of the Year" for representing plaintiffs in class actions and mass torts.

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Lieff Cabraser Heimann & Bernstein, LLP
Lexi J. Hazam, 415-956-1000

Release Summary

Lieff Cabraser announces children of Renate Winkler, who died from CRE infection after ERCP procedure, filed wrongful death lawsuit against Pentax Medical for defective design of medical scope.


Lieff Cabraser Heimann & Bernstein, LLP
Lexi J. Hazam, 415-956-1000