Olympus Endoscope Infection Lawsuit: Duodenoscope Superbug Claims and Who Qualifies

A duodenoscope is a flexible, reusable scope threaded through the mouth into the small intestine for ERCP, a procedure used to treat gallstones, blockages, and cancers of the bile duct and pancreas. Plaintiffs say its complex design lets dangerous bacteria become trapped inside even after cleaning.

Lawsuits allege that Olympus duodenoscopes were designed in a way that made them hard to clean reliably, that Olympus knew of infection outbreaks, and that it failed to warn hospitals and the FDA. Outbreaks of carbapenem-resistant Enterobacteriaceae (CRE), a superbug that by some estimates kills 40% to 50% of patients whose bloodstream it reaches, were linked to Olympus scopes at hospitals including Virginia Mason in Seattle and UCLA in Los Angeles.

Claims are brought under state law for design defect, negligence, failure to warn, and in fatal cases, a wrongful death claim. Hospitals are sometimes co-defendants when cleaning practices are at issue. Olympus has said its scopes are safe and effective with proper cleaning and disinfection.

These cases are different from a typical recall claim. A contaminated scope does not stay broken the way a defective part does; it can pass bacteria from one patient to the next until the problem is caught. That is why outbreak investigations by hospitals and public health officials, which trace infections back to specific scopes, are often the strongest evidence. If you are still deciding whether to pursue a claim, our guide to finding a lawyer for a consumer or injury claim explains what to ask.

UCLA and Virginia Mason

In February 2015, UCLA's Ronald Reagan Medical Center said seven patients had been infected with CRE, two of whom died, and it notified 179 others who may have been exposed through contaminated scopes. At Virginia Mason, 39 patients' infections were linked to Olympus scopes and 18 died. In the first U.S. trial over scope outbreaks, a Seattle jury in July 2017 ordered Olympus to pay the hospital $6.6 million and found Olympus failed to provide adequate warnings or instructions after the scope was made, but rejected the claim that the scope was unsafe as designed. The jury also found the hospital negligent and ordered it to pay $1 million to the family of patient Richard Bigler.

The 2018 guilty plea

Olympus Medical Systems Corporation pleaded guilty in federal court in Newark on December 10, 2018 to three counts of distributing misbranded medical devices, admitting it failed to file required adverse event reports about infections, and was fined $80,000,000 with $5,000,000 in criminal forfeiture. A former senior executive also pleaded guilty.

Recent FDA action

The FDA sent Olympus warning letters from November 2022 to March 2023, including one dated March 15, 2023 citing failures in medical device reporting procedures after a November 2022 inspection in Tokyo. In June 2025, the FDA issued import alerts to keep 58 models of Olympus devices, including ureteroscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors, out of the U.S. because of outstanding quality system violations. Hospitals may keep using devices they already own that work as intended.

According to 2017 reporting, at least 35 patients in American hospitals had died since 2013 after infections tied to Olympus duodenoscopes. The DOJ said Olympus admitted it failed to file required reports with the FDA about infections connected to the scopes while continuing to sell them in the United States.

Attorneys reviewing scope infection cases usually look for:

• A scope procedure, most often ERCP with a duodenoscope, where the records identify an Olympus device.
• A serious infection that began within days or weeks, especially antibiotic-resistant bacteria like CRE, or sepsis requiring hospitalization.
• A link such as a hospital exposure notice, an outbreak investigation, or matching bacteria found on the scope.
• Harm: ICU care, organ damage, prolonged treatment, or death.

These cases are hard to prove without a clear connection. Many ERCP patients are already very sick, and hospital-acquired infections have many causes. A case is stronger when public health officials or the hospital tied infections to specific scopes.

Timing and paperwork matter most. Hospitals that identify a contaminated scope often notify every patient treated with it during a set window, as UCLA did when it contacted 179 patients treated from October 2014 to January 2015. If you received a letter like that and later got sick, keep it with your medical records.

Scopes from other manufacturers are outside the claims described here.

Because there is no settlement program, compensation comes from individual verdicts or confidential settlements. The one widely reported U.S. trial produced a $6.6 million award to Virginia Mason against Olympus in 2017, with a separate $1 million the jury ordered the hospital to pay the patient's family. That outcome shows both the potential and the risk: the jury rejected the design defect theory while finding a warnings failure.

Damages in individual cases can include medical expenses, lost wages, pain and suffering, and in death cases, losses to the family. Attorneys handling these cases generally work on contingency.

The Virginia Mason verdict came after an eight-week trial, the first U.S. trial over gastrointestinal scope outbreaks, which shows how long and expensive these cases can be. That cost is one reason many scope cases settle confidentially rather than go to trial.

Scope infection cases are state-law product liability and negligence claims. Plaintiffs typically argue the design made the scope impossible to clean reliably, that Olympus's cleaning instructions were inadequate, and that it hid known outbreaks. Olympus often argues the hospital did not follow reprocessing instructions, which is why hospitals can end up sharing fault.

The 2018 plea is an admission that Olympus failed to report infection-related adverse events it was required to file with the FDA, which plaintiffs use to support claims that doctors and hospitals were not warned. Each medical device case also turns on the scope model and the clearance pathway it went through.

Infection claims are governed by your state's statute of limitations for personal injury, commonly two or three years, while wrongful death deadlines usually run from the date of death. Some states treat claims against hospitals as medical malpractice, which can carry shorter deadlines and notice requirements.

A hospital's exposure notice letter often marks when a patient knew or should have known of a possible scope link, so keep it and note the date.

Scope outbreaks are sometimes discovered months after the procedures, when a hospital traces a cluster of infections. If you learn only now that your earlier infection may have come from a contaminated scope, that later discovery date may matter under your state's rules, which is a question to raise with an attorney promptly.

Write down the procedure date and the date you first got sick.

ERCP is common. About 700,000 ERCP procedures are performed each year, according to 2017 reporting on the Virginia Mason trial, so even a small contamination rate can affect many patients. Doctors use duodenoscopes to diagnose and treat problems such as gallstones, cancers, and bile duct blockages.

Design, cleaning, or both

The Virginia Mason trial shows how fault can be split. Olympus argued the hospital failed to follow reprocessing instructions. The jury rejected the claim that the scope was unsafe as designed, but found Olympus failed to provide adequate warnings or instructions after manufacture, and also found the hospital negligent. The scope model in that case, the TJF-Q180V, had been recalled in 2016, when Olympus recalled all 4,400 of those scopes and made repairs intended to reduce the chance of bacteria being trapped after cleaning.

What the FDA found more recently

The FDA's March 15, 2023 warning letter followed an inspection of an Olympus facility in Tokyo from November 7 to 10, 2022. It cited failures to develop, maintain, and implement written medical device reporting procedures under 21 CFR 803.17(a). By June 2025, the FDA said Olympus still had outstanding quality system violations and issued import alerts covering 58 models, including ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors.

Who can be sued

• The manufacturer, for design defects, inadequate cleaning instructions, or failure to warn and report.
• The hospital or clinic, if it failed to follow reprocessing instructions; these claims may be treated as medical malpractice with special notice rules.
• Both, with a jury splitting responsibility, as happened at Virginia Mason.

An attorney will usually request the hospital's infection control records and any public health investigation to see which theory fits.

1. Get treatment and follow your infectious disease team's advice.
2. Request your procedure report, which usually names the scope model and serial number.
3. Save any hospital letter about possible exposure, and ask whether an outbreak was reported to public health authorities.
4. Get culture results showing the organism.
5. Do not sign releases from a hospital or manufacturer without advice.

In a case review, expect questions about the procedure date and hospital, why you had the scope procedure, when symptoms of infection began, what organism was found, and whether the hospital contacted you about exposure. Families of patients who died may ask on their behalf. With your permission, an attorney can request the procedure report, infection control records, and culture results.

Independent attorneys who handle device and hospital infection cases can assess whether a claim is viable. A free case review takes about two minutes. Related: the Bair Hugger surgical infection lawsuit, the port catheter lawsuit, and our guide to how to sue a company.