Wrongful Death Lawsuit Filed Against Olympus Over ERCP Infection

The parents of a young boy who died from an infection following an ERCP (endoscopic retrograde cholangiopancreatography) procedure at UCLA Medical Center are pursuing a product liability lawsuit against Olympus, alleging that inadequate cleaning instructions were provided for a device used during the surgery.

Jeffery John Hughes and Annie Ruth Hughes, of California, filed a wrongful death lawsuit (PDF) last month in the U.S. District Court for the Central District of California against Olympus Medical Systems, which manufactured and sold the duodenoscope used at hospital.

Due to problems with the “reprocessing” instructions provided for cleaning and reusing the devices, Olympus duodenoscopes have been linked to a number of infections at different hospitals, including a recent outbreak of aggressive carbapenem-resistant enterobacteriaceae (CRE) infections at UCL Ronald Reagan Medical Center between October 2014 and January 2015, which has been linked to at least seven infections and two deaths.

According to the Hughes lawsuit, their son, Jeffrey Hughes, was one of the fatalities linked to a contaminated Olympus Q180V duodenoscope used at UCLA. Hughes died following an endoscopic retrograde cholangiopancreatography (ERCP) procedure in December 2014. The family of the other fatality, Antonia Cera, a 48-year-old mother, filed a wrongful death lawsuit against Olympus in February.

The CRE infections have been described as a “nightmare bacteria”, as it not only resists treatment by antibiotics, but also 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.

Following the recent infection outbreaks, the FDA has warned about problems cleaning duodenoscopes, indicating that even when doctors and health care professionals follow the recommended cleaning steps, patients may still face a risk of infections.

Many of the devices include a movable “elevator” at the tip, which may trap pathogens and blood even when recommended cleaning techniques are used.

Recent reports suggest that Olympus warned European regulators and doctors that material could become trapped in the tips, but failed to provide the same warning to doctors and the FDA in the U.S.

According to a story by The Los Angeles Times, Olympus first sent a letter to European hospitals in January 2013, suggesting that they use a special brush to clean the duodenoscopes.

They again sent a warning to European regulators and hospitals in August 2014, which some countries, like Saudia Arabia and Switzerland, interpreted as a Q180V duodenoscope recall.

“Recently Olympus has received a few complaints of residual debris in the distal end of the TJF Q180V duodenoscope after reprocessing,” the warning states. “Olympus has determined to revise our reprocessing instructions and recommends the use of an additional cleaning brush.”

According to the Los Angeles Times, U.S. doctors, patients and regulators were specifically not given the same courtesy. The revelations that the company changed its reprocessing protocols in other parts of the world, but specifically avoided doing so in the U.S., have led to calls for congressional hearings.

“The reprocessing protocols provided by Defendants, to be used in the operation of their Q180V Scope, were inadequate,” the Hughes lawsuit states. “Despite complying with the protocols which Defendants provided, and which Defendants instructed the UCLA Hospital to implement, multiple patients, including Plaintiffs’ decedent, were infected with a highly drug-resistant bacteria.”

Since the outbreaks, Olympus has released new reprocessing protocols in the U.S., which the FDA says have been validated as being effective in cleaning the problematic duodenoscopes.

The Hughes are seeking compensatory and punitive damages, and charge Olympus Corp. with product liability, wrongful death, negligence, fraud and negligent misrepresentation.