ERCP Infection Lawsuits Filed Against Duodenoscopes Makers Over CRE Outbreak

Olympus Corp. faces at least two product liability lawsuits, including a wrongful death claim, following antibiotic-resistant infections alleged caused by duodenoscopes used during ERCP procedures at UCLA’s Ronald Reagan Medical Center.

At least 179 patients who under went an endoscopic retrograde cholangiopancreatography (ERCP) at the California hospital between October 2014 and January 2015 have been warned that they may have been exposed to a risk of carbapenem-resistant enterobacteriaceae (CRE) infections, after at least seven illnesses and two deaths were linked to contaminated duodenoscopes manufactured by Olympus.

On Wednesday, the family of Antonia Cerda, a 48-year-old mother, filed a wrongful death lawsuit, alleging that the manufacturer was provided inadequate warnings and instructions about the proper cleaning of the endoscopic surgery devices.

The complaint comes just days after another ERCP infection lawsuit was filed by Aaron Young, an 18-year-old high school student still recovering from the illness, raising similar allegations against the Japanese medical device manufacturer.

According to the claims, patients may be exposed to a risk of infections following ERCP procedures, even if the duodenoscopes are cleaned according to the manufacturer instructions.

The ERCP infections have been described as a “nightmare bacteria”, as CRE not only resists treatment by antibiotics, but it results in death for about those it infects.

Duodenoscopes are flexible, lit tubes that are inserted down the throat to the top of the small intestines for gastrointestinal procedures. They allow contrast dye to be injected and can be used with other medical instruments to retrieve biopsy samples. The FDA estimates that more than 500,000 ERCP duodenoscope procedures occur each year in the U.S.

According to an FDA safety communication issued last week, duodenoscopes may have designs that make them difficult to clean properly even when doctors and health care professionals follow the recommended steps for cleaning it. Many of the devices include a movable “elevator” at the tip, which may trap pathogens and blood even when recommended cleaning techniques are used.

Both of the lawsuits accuse Olympus of negligence due to inadequate cleaning instructions it allegedly provided to the medical community on how to properly sanitize the instruments after an ERCP procedure. Neither claim targets UCLA, which says it followed the company’s recommended cleaning procedures to the letter.

Attorneys familiar with the case say that there are likely more lawsuits pending.