Duodenoscope infection lawsuits are product liability and wrongful death claims brought by patients and families who contracted drug-resistant infections after an ERCP procedure performed with a contaminated reusable scope. The primary defendant is Olympus Corporation, which makes roughly 85% of the duodenoscopes used in the United States, though Fujifilm and Pentax devices have also drawn regulatory scrutiny. Plaintiffs allege the scopes’ design traps bacteria that survive standard cleaning, and that manufacturers knew this for years before warning U.S. hospitals. The litigation has produced jury verdicts, confidential settlements, an $85 million criminal plea by Olympus Medical Systems Corporation, and, starting in 2026, a new round of wrongful death claims tied to a newer generation of scopes.
Who Can Sue and on What Grounds
Claims have been filed by patients infected during ERCP and by the families of patients who died of those infections. The legal theories fall into a few groups:
- Design defect: the elevator mechanism’s crevices, seams, and O-ring seal make the scope impossible to clean adequately, and safer alternatives, including fully disposable designs, were feasible.
- Failure to warn: Olympus knew its cleaning protocols did not eliminate contamination but did not disclose that risk to hospitals, physicians, or patients, and withheld from U.S. customers safety warnings it had already issued in Europe.
- Negligent reprocessing instructions: the company’s validated cleaning instructions were demonstrably incorrect and in some cases contributed to contamination.
- Fraudulent concealment: Olympus delayed recalls and redesigns to protect market share, submitted misleading reports to the FDA, and concealed internal knowledge of contamination clusters.
- Medical negligence: some suits also name hospitals for improper training, failure to act on known infection risks, or failure to report adverse events.
As of mid-2026, there is no multidistrict litigation or class action consolidating these cases. Claims are being filed and resolved individually, in state and federal courts.
The Injury Plaintiffs Have to Prove
Duodenoscopes are flexible, camera-tipped instruments threaded down a patient’s throat to reach the bile ducts, pancreas, and gallbladder. What makes them different from other endoscopes is a mechanical “elevator” at the tip, sitting inside a channel with crevices, seams, and a small O-ring seal. Blood and tissue get forced past that seal during use and settle into recesses that cleaning brushes and disinfectants cannot reach.
An independent investigator hired by Olympus and a Dutch hospital concluded as early as June 2012 that this design trapped bacteria in the device tip. Post-market surveillance data showed that between 3% and 5.4% of reprocessed scopes tested positive for high-concern bacteria; some independent studies put the rate at 15% to 22%. The organisms found included carbapenem-resistant Enterobacteriaceae (CRE), multidrug-resistant Pseudomonas aeruginosa, vancomycin-resistant Enterococcus (VRE), and MRSA. Since 2013, at least 35 patients have died and hundreds more have been infected or exposed worldwide, according to federal investigators and the U.S. Senate.
A Senate investigation later documented at least 25 separate outbreaks between 2012 and spring 2015, affecting a minimum of 250 patients globally. The most publicized was at UCLA’s Ronald Reagan Medical Center, where seven patients were confirmed infected with CRE between October 2014 and January 2015 and two died. Earlier, at Virginia Mason Medical Center in Seattle, 39 patients were infected and 18 died in an outbreak tied to Olympus scopes. The Senate HELP Committee documented that during the roughly 17 months the FDA took to alert the public after first learning of contamination problems in September 2013, at least 68 patients were infected at seven U.S. hospitals.
What Olympus Knew and When
The failure-to-warn and fraud claims rest on a documented timeline built from internal emails obtained in discovery and by congressional investigators.
By May 2012, Olympus had an independent lab report by Dr. Arjo Loeve confirming that its closed-channel duodenoscope could harbor and spread bacteria even when cleaned per instructions. By the end of that year, the company had two confirmed clusters of contaminated scopes causing patient infections in Europe. Olympus issued safety advisories to European hospitals in January 2013 and August 2014. No equivalent warning went to American hospitals.
In January 2013, Laura Storms, Olympus’s U.S. vice president of regulatory and clinical affairs, emailed Tokyo asking whether American hospitals should receive the same warnings. Susumu Nishina, the chief manager for market quality, replied that it was “not necessary” and that the risk was “acceptable.” The same day, a U.S. regulatory affairs director flagged a possible “duodenoscope safety recall” in light of positive bacterial testing at the University of Pittsburgh Medical Center. Storms relayed Tokyo’s decision that a global communication was “not required.”
In March 2014, a University of North Carolina researcher notified Olympus that 40% of tested scopes at his facility were contaminated despite adherence to the company’s protocols. An Olympus U.S. employee marked the information “Urgent: Confidential.” Internal emails showed the company consistently blamed hospitals for “insufficient reprocessing” rather than acknowledge a design problem. Virginia Mason had also notified Olympus directly that the elevator channel prevented adequate cleaning; Olympus did not recall the device, modify the design, or alert other hospitals.
The Senate investigation concluded that Olympus failed to apply for FDA clearance before selling its modified closed-channel design in the United States, lacked sufficient data to prove its cleaning instructions worked, and submitted medical device reports that understated the number of affected patients.
Verdicts, Settlements, and the Criminal Plea
The Bigler Trial
The first major trial involved the family of Richard Bigler, a pancreatic cancer patient who died in August 2013 after an ERCP at Virginia Mason. In a June 2017 trial in King County Superior Court in Washington, the jury ordered Olympus to pay Virginia Mason $6.6 million, finding the company failed to provide adequate warnings or instructions. The same jury ordered Virginia Mason to pay $1 million to the Bigler family for negligence, but rejected the claim that the Olympus duodenoscope was unsafe by design.
In January 2018, Judge Steve Rosen ordered a new trial, finding that Olympus had committed “willful discovery violations” by failing to translate internal Japanese-language documents and failing to disclose hospital test results. The judge called it a “massive impropriety” and ordered Olympus to pay $250,000 in sanctions plus the Biglers’ legal expenses for the retrial. By December 2018, Theresa Bigler and fellow plaintiff Deborah Shawver reached a confidential settlement with Olympus, resolving their wrongful death claims.
UCLA Cases
The first UCLA lawsuit was filed on February 23, 2015, by Aaron Young, an 18-year-old student who contracted CRE after procedures with a contaminated Olympus TJF-Q180V in October 2014 and January 2015. Two days later, the family of Antonia Torres Cerda, who died on November 8, 2014, filed a wrongful death suit. Both were filed in Los Angeles County Superior Court alleging negligence, product liability, and fraud. Outcomes of these specific cases have not been publicly reported.
Confidential Settlements
More than 25 patients and families have sued Olympus for wrongful death, negligence, or fraud over the first wave of outbreaks. Olympus entered into multiple confidential settlements, including two in December 2018 with families of patients who died from superbug infections.
The $85 Million Criminal Plea
On December 10, 2018, Olympus Medical Systems Corporation pleaded guilty in the U.S. District Court for the District of New Jersey (Case No. 2:18-cr-00727) to three counts of distributing misbranded medical devices. The charges centered on the company’s failure to file required adverse event reports with the FDA regarding the 2012 European outbreaks. Judge Stanley R. Chesler imposed an $80 million fine and $5 million in criminal forfeiture.
Hisao Yabe, the former division manager for quality and environment and Olympus’s top regulatory official responsible for U.S. adverse event reporting, pleaded guilty to one count. Yabe admitted personal responsibility for failing to report the Erasmus Medical Center infections and acknowledged he was aware of the Delft University of Technology expert report identifying design flaws in the Q180V. Judge Chesler sentenced him to one year of probation and a $5,000 fine, telling him on the record: “You deserve to be professionally disgraced.”
FDA Enforcement
The FDA warned hospitals in February 2015 that duodenoscopes could spread “deadly bacteria.” In August 2015 it cited Olympus for failing to report potential injuries and deaths within the required 30-day window. In October 2015 the agency ordered Olympus, Fujifilm, and Pentax to conduct post-market surveillance studies. A March 2018 warning letter found Olympus had enrolled zero sites and zero participants in the mandated studies, missing deadlines by over a year, and declared the devices “misbranded.” Additional warning letters followed in November 2022 and March 2023. In 2023, the FDA accused Olympus of “a troubling disregard for patient safety.” On June 24, 2025, the agency issued Import Alert 89-04, blocking 58 Olympus device models manufactured at the Aizu facility in Japan.
The Second Wave: 2025–2026 Cases
Litigation appeared to be winding down until a series of 2025 safety events pulled the newer generation of Olympus scopes into the same problem.
In May 2025, Olympus revised the reprocessing manual for its TJF-Q190V, Q290V, and Q170V models, removing a 24-hour detergent presoak option after the company’s own data showed it was associated with higher microbial contamination when cleaning was delayed. On October 17, 2025, Olympus issued an Urgent Field Safety Notice for those same models, acknowledging two deaths and five serious injuries linked to infections or positive cultures since 2024. The notice conceded that “naked-eye inspection cannot reliably detect the irregularities and damage that can trap bacteria” and mandated inspection of the scope tip under 10x magnification. In January 2025, Olympus also recalled a single-use distal cover for the TJF-Q190V because the cover could detach inside patients.
On June 5, 2026, a wrongful death lawsuit was filed in federal court in Washington alleging that a patient developed a fatal vancomycin-resistant Enterococcus infection following an ERCP with an Olympus TJF-Q190V. The patient died of septic shock and organ failure. The complaint asserts the infection was introduced via the scope and that Olympus failed to address known contamination risks despite the hospital’s adherence to cleaning protocols. Law firms across the country are reviewing similar potential claims tied to the newer scope models.
Claims Involving Fujifilm and Pentax Scopes
Although Olympus dominates the market and the litigation, Fujifilm and Pentax have faced their own regulatory problems. Both received FDA warning letters in March 2018 for failing to satisfy post-market surveillance requirements. Pentax issued a voluntary recall of its ED-3490TK duodenoscope in February 2018 after the FDA flagged cracks and gaps in the distal cap that allowed fluid and bacteria infiltration. Fujifilm recalled its ED-530XT model over contamination risks. In August 2019, the FDA noted all three manufacturers were withdrawing their older fixed-endcap duodenoscope models from the market.
The Senate HELP Committee found that Fujifilm and Pentax also failed to file 510(k) applications for design modifications, failed to validate their reprocessing instructions, and submitted delayed or incomplete adverse event reports. The design-defect and failure-to-warn theories that have driven the Olympus cases apply to the other manufacturers as well, and a patient injured by a Fujifilm or Pentax scope may have a claim on the same grounds.
If You Think You Were Infected
The infections at issue in these lawsuits are drug-resistant bacterial infections, typically appearing after an ERCP procedure. Key facts to preserve include the date and location of the procedure, the make and model of the scope used (which the hospital’s records will show), the identity of the treating physician and facility, and the culture results identifying the specific organism. Statutes of limitations for product liability and wrongful death claims vary by state and can be short, particularly where the injury was diagnosed years before the connection to the scope became clear. Individual review by a lawyer handling medical device cases is the practical next step; there is no consolidated proceeding to opt into.