Duodenoscope Lawsuit Filed Against Olympus Over UCLA Infection

Olympus Corp. continues to face a mounting number of duodenoscope lawsuits over an antibiotic-resistant infection outbreak at UCLA Medical Center, which has been traced back to an inability to properly clean and sanitize medical devices made by the company. 

The latest lawsuit was filed by Staci Simos and her husband, Michael Simos in Los Angeles Superior Court. According to the complaint, Simos contracted carbapenem-resistant enterobacteriaceae (CRE) after an endoscopic retrograde cholangiopancreatography (ERCP) procedure at UCLA’s Ronald Reagan Medical Center in October.

She was one of at least seven individuals treated at the hospital to develop the severe “superbug” infection, which has caused two deaths. The outbreak has been linked to the Olympus Q180V duodenoscope, which is used during the endoscopic procedure.

The facility has confirmed that nearly 200 patients who underwent an ERCP between October 2014 and January 2015 needed to be tested for the deadly superbug CRE due to contaminated scopes. A number of other facilities have also reported superbug infections linked to duodenoscopes.

The confirmed infections occurred despite the medical scopes being sterilized according to manufacturers specifications, leading the FDA to issue a warning to about duodenoscope cleaning problems earlier this year.

During the ERCP procedure, the scope is sent through the mouth, down the throat to the stomach and small intestine to drain fluid from pancreatic and biliary ducts. These scopes have been linked to other infections for years.

The outbreaks call into question the safety and reliability of the current cleaning procedures. Following the UCLA outbreak, the duodenoscopes were pulled and a heightened protocol was implemented, one going above and beyond that recommended by the manufacturers.

Several ERCP infection lawsuits have already been filed  against Olympus over the duodenoscopes linked to the UCLA outbreak. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.

The Department of Justice is reportedly investigating the potential for criminal charges against Olympus and other duodenoscope manufacturers.

A number of recent reports indicate that the subpoenas were sent to Olympus Corp. Fujifilm and Pentax, as well as Virginia Mason Medical Center, although the Justice Department has not confirmed the investigation. Both Olympus and Virginia Mason officials have confirmed receiving the subpoenas.

Exposure to the CRE superbug following an ERCP poses a serious risk of illness, as the bacteria kills 40% to 50% of patients after spreading to the bloodstream.

The company has since released new cleaning instructions for its duodenoscopes, which the FDA approved.