Olympus Scope Lawsuit 2026: Claims, FDA Actions & Payouts

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Olympus Scope — Infection Claims

Hospitalized With an Infection After a Scope Procedure?

If you were told it was “just a complication,” Olympus’s federal guilty plea — and $85 million in penalties — tell a different story. In two minutes, you can know whether your case qualifies.

ACTIVE LITIGATION. 250+ patients · most recent filing: June 2026 · deadlines vary by state — some as short as one year.

Were you hospitalized with an infection within 30 days of an endoscopy or scope procedure?

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Free · confidential · no fee unless there is a recovery · answering doesn’t commit you to anything. Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.

Prefer to talk it through? (888) 348-2735 — free and confidential.

Stefanie A. Murphy & Matthew T. Marin

Partners

You’ll get a straight answer even if it’s “you don’t qualify.” Everything you share is confidential — even if you never hire us. No fee unless there is a recovery; costs are advanced and reimbursed only out of a recovery. If you do qualify, our Olympus scope litigation team requests the medical and hospital records — you don’t chase them.

Qualification depends on what the medical records show — the scope involved, the infection, and the timing. We’ll review them and give you a straight answer either way.

Matthew T. Marin, J.D. — Admitted in Rhode Island, South Carolina, Connecticut, and Massachusetts
Stefanie A. Murphy, J.D. — Admitted in Rhode Island, Connecticut, and Massachusetts

What Is the Olympus Scope Lawsuit?

The Olympus scope lawsuit is a product liability litigation targeting Olympus Medical Systems Corporation and its parent, Olympus Corporation, for designing, manufacturing, and selling flexible endoscopes — primarily duodenoscopes, bronchoscopes, and other gastrointestinal scopes — that are defective in design because their internal architecture makes them impossible to fully sterilize using standard hospital reprocessing protocols.

The core legal argument is straightforward: the design of Olympus scopes, particularly the fixed elevator mechanism in duodenoscopes, creates a recessed chamber at the distal tip where bacteria accumulate after patient contact. Standard high-level disinfection — the cleaning process hospitals use to prepare scopes for reuse — does not reliably penetrate these recessed areas. Independent peer-reviewed research confirms this failure.

A 2022 meta-analysis of 9,084 post-reprocessing cultures found 5% contamination even after enhanced cleaning protocols. When hospitals follow Olympus’s instructions exactly, a significant share of patient-ready duodenoscopes carry gastrointestinal bacteria. An 8-year retrospective study at a Dutch tertiary-care hospital University Medical Center found that by 2022, 94.7% of patient-ready scopes showed measurable bacterial contamination, and that every manufacturer-recommended intervention failed to produce a meaningful reduction.

(Source: Bomman et al., Clinical Endoscopy, January 2022, PMC8831410; van der Ploeg et al., Gut, 2024;73(4):613-621, PMID 38182137.)

The contamination problem is not new, and Olympus has known about it for more than a decade. In November 2012, a U.S. teaching hospital identified scope-related infections and notified Olympus. Rather than reforming its design or issuing meaningful warnings, Olympus continued marketing and distributing scopes with the same defective architecture. Between 2013 and 2015, multiple major U.S. hospitals reported CRE outbreaks linked directly to Olympus duodenoscopes.

Virginia Mason Medical Center in Seattle documented 32 confirmed infections and 18 outbreak-associated deaths. Ronald Reagan UCLA Medical Center reported 17 patient cases, 2 deaths, and 179 patients potentially exposed. The Senate HELP Committee’s January 2016 report, “Preventable Tragedies”, named hospitals across the country and estimated at least 250 patients had been affected — calling the figure likely a significant undercount.

The legal watershed came in December 2018. Olympus Medical Systems Corporation and former senior executive Hisao Yabe pleaded guilty in federal court to three counts of distributing misbranded medical devices. The company paid $85 million in penalties and formally admitted failing to file FDA-required adverse-event reports — including scope-related patient infections — from the FDA. (Source: DOJ press release, December 10, 2018; Case No. 2:18-cr-00727-SRC, U.S. District Court, D.N.J.) This criminal conviction fundamentally changes the litigation landscape: Olympus cannot credibly claim before a jury that it lacked knowledge of its scopes’ contamination risks.

The most recent major regulatory development is Olympus’s October 2025 Urgent Field Safety Notice, which disclosed 2 additional deaths and 5 serious injuries linked to current-generation TJF scopes. In that notice, Olympus explicitly acknowledged that prior cleaning protocols were insufficient and required hospitals to implement 10x magnification inspection — a safeguard that had never previously been required.

As of April 2026, no Olympus scope MDL has been filed, but individual cases are proceeding in federal and state courts. In Bigler v. Olympus (King County Superior Court, July 24, 2017) — the only case in this litigation tried to verdict — the jury found Olympus liable for failure to warn and rejected the design-defect claim. It awarded $6.6 million to Virginia Mason Medical Center for the hospital’s own losses, and $1 million to the patient’s family, which the hospital was ordered to pay. The $6.6 million is a hospital’s commercial recovery, not a patient award, and is not an indicator of individual case value.

That verdict was obtained by the plaintiffs’ trial counsel in that case — not by Marin & Murphy Law Firm, which had no role in the Bigler litigation. In January 2018 the court granted the patient’s family a new trial after finding that Olympus had withheld internal safety records, and the family’s claims were later resolved by confidential settlement. It is cited here as public-record context only; results vary, and no outcome in another case predicts or guarantees a similar result in any other matter.

What Contamination Problem Makes Olympus Scopes Dangerous?

The contamination problem in Olympus scopes is a direct consequence of their design — specifically, the elevator mechanism at the distal tip of duodenoscopes. During an ERCP (endoscopic retrograde cholangiopancreatography) procedure, the duodenoscope is advanced through the patient’s mouth, through the stomach, and into the duodenum — the first section of the small intestine. At this point, the tip of the scope is inside one of the most bacteria-rich environments in the human body. The elevator mechanism, a small mobile lever at the scope’s tip, is used to guide instruments like catheters and guidewires into the bile duct and pancreatic duct during the procedure.

The elevator mechanism is recessed beneath a movable metal flap. This design creates an enclosed space — a narrow channel that fills with patient material (blood, bile, intestinal fluid, bacteria) during every procedure. After the procedure, when hospital staff attempt to reprocess the scope, standard high-level disinfection cannot reliably reach this enclosed space. Cleaning brushes cannot access the cavity. Flushing fluid cannot fully irrigate it. The fixed elevator design is the engineering defect that drives patient infections.

This is sometimes described as the “garden hose” problem: even if you run water through the outside of a kinked hose, material trapped in the kink does not flush out. In a duodenoscope, the elevator mechanism creates a structural kink in the cleaning pathway — and the material trapped there is patient bacteria that can be transferred to the next patient.

Independent research consistently confirms that this design defect cannot be overcome through reprocessing improvements alone. The first major peer-reviewed study, by Ross et al. in Gastrointestinal Endoscopy (2015, PMID 26092616), found that 4 of 8 Olympus duodenoscopes tested at Virginia Mason were culture-positive, and that no breach in the high-level disinfection protocol was identified — meaning the hospital did everything right and the scopes were still contaminated. The 2022 Bomman meta-analysis covering 9,084 cultures confirmed 5% contamination after enhanced protocols.

The van der Ploeg 2024 a Dutch tertiary-care hospital study tracked outcomes over 8 years and found that every intervention Olympus recommended — disposable endcap designs, new automated reprocessing machines, staff audits — failed to meaningfully reduce contamination rates.

It is important to understand the a Dutch tertiary-care hospital contamination figure accurately. The 94.7% figure describes AM20 contamination — any bacterial count at or above 20 colony-forming units per 20 milliliters, including environmental bacteria and skin flora. This is not a claim that 94.7% of scopes carry patient-origin bacteria. The patient-origin bacteria (MGO) contamination rate ranged from 14.3% to 47.5% annually across the 8-year study period.

Both figures are significant: the broad AM20 number shows the reprocessing environment is overwhelmed; the narrower MGO range demonstrates that patient-to-patient transmission risk is real and persistent despite all manufacturer-recommended interventions.

Olympus has publicly argued, through a 2025 prospective study at a Dutch tertiary-care hospital, that no duodenoscope-associated infections were detected in a 341-procedure cohort. The authors estimated the residual transmission risk at under 0.9%, with follow-up samples returned by 61.6% of exposed patients, and they credited that result to monthly routine microbiological surveillance with active quarantine rather than to the scope design.

The same study found that 21.4% of procedures involved contaminated duodenoscopes. (van der Ploeg et al., J Hosp Infect 2025;160:101-108, PMID 40058528.) The study includes no Olympus arm, so it does not compare designs. Defense counsel will cite it; three distinctions plaintiffs will draw: first, the study used a competing manufacturer’s scopes with disposable endcap designs, not Olympus TJF scopes with the fixed elevator mechanism at issue in this litigation; second, the surveillance-and-quarantine protocol is far beyond standard U.S. hospital practice; third, the study covers 2022-2023, the post-protocol era, not the 2015-2020 core claims period when most plaintiffs were infected.

Which Hospitals Have Been Linked to Olympus Scope Outbreaks?

Multiple U.S. hospitals have documented CRE and multidrug-resistant organism outbreaks linked to Olympus endoscopes. The following institutions and data are confirmed from peer-reviewed literature, government investigations, and congressional records.

Virginia Mason Medical Center — Seattle, Washington

The Virginia Mason outbreak is the most extensively documented in the litigation and produced The Bigler verdict awarded $6.6 million to Virginia Mason for the hospital’s own losses and $1 million to the patient’s family — not a patient award, and not a benchmark for individual claims. Between November 2012 and August 2013, during 1,149 ERCP procedures, 32 patients were confirmed infected with multidrug-resistant E. coli.

Seven patients died within 31 days of positive culture. By March 2015, 16 patients had died, and 18 total outbreak-associated deaths were recorded. Four of 8 Olympus duodenoscopes tested were culture-positive. The hospital had followed manufacturer instructions exactly — no breach in the high-level disinfection protocol was identified. (Source: Ross et al., Gastrointest Endosc. 2015 Sep;82(3):477-83. PMID 26092616.)

Ronald Reagan UCLA Medical Center — Los Angeles, California

At UCLA, 17 patients were affected: 9 confirmed active CRE infections, 7 asymptomatic carriers, and 1 index patient. Two patients died. Approximately 179 patients were potentially exposed. The pathogen was blaOXA-232 carbapenem-resistant Klebsiella pneumoniae. As at Virginia Mason, investigators found no deviation from FDA or manufacturer reprocessing recommendations. (Source: Humphries et al., Clin Infect Dis. 2017;65(7):1159-1166. PMID 29579235.)

an Illinois teaching hospital — Illinois

The 2013 Illinois teaching-hospital outbreak involved 39 case patients. The exposure odds ratio was 78 (95% CI, 6.0–1008; P<.001) — patients who underwent ERCP at this hospital were 78 times more likely to develop NDM-CRE infection than non-ERCP patients. (Source: Epstein et al., JAMA. 2014;312(14):1447-1455. PMID 25291580.)

Senate HELP Committee Named Hospitals

Multiple U.S. hospitals were named in the U.S. Senate HELP Committee report released January 13, 2016. The report estimated at least 250 patients affected worldwide, across all three duodenoscope manufacturers — a figure described as likely a significant undercount.

The defendant in this litigation is Olympus Corporation — not the hospitals. Every hospital named above followed Olympus’s cleaning instructions exactly, as confirmed by regulatory investigations. Olympus provided those instructions and later admitted failing to file the required adverse-event reports with the FDA.

What Is Olympus Corporation’s Full Regulatory and Criminal History?

Fall 2012 — Hospital Notification. A U.S. teaching hospital identified scope-related infections and notified Olympus. Olympus did not issue any warning to hospitals or the FDA.

February 19, 2015 — FDA Safety Communication. The FDA received 75 MDRs involving approximately 135 patients between January 2013 and December 2014 and issued a Safety Communication warning that manufacturer cleaning instructions may be insufficient.

January 13, 2016 — Senate HELP Committee Report. “Preventable Tragedies” concluded that Olympus and other manufacturers had known about contamination risks for years, failed to warn hospitals and regulators adequately, and that at least 250 patients had been affected worldwide, across all three duodenoscope manufacturers.

March 9, 2018 — FDA Warning Letter MARCS-CMS 546986. More than two years after a mandatory postmarket surveillance order, zero Olympus surveillance sites had been established. (Source: FDA Warning Letter 546986.)

December 10, 2018 — Federal Criminal Guilty Plea. Olympus Medical Systems Corporation and executive Hisao Yabe pleaded guilty to three counts of distributing misbranded devices. $85 million paid. Olympus admitted failing to file FDA-required adverse-event reports. Case No. 2:18-cr-00727-SRC, D.N.J.

March 2023 — FDA Warning Letter MARCS-CMS 654013. Cracked MAJ-2315 distal end covers — Olympus failed to investigate complaints for approximately two years. (Source: FDA Warning Letter 654013.)

December 18, 2024 — MAJ-891 Class I Recall. 30,140 units recalled. 120+ injuries, 1 death. FDA Recall No. Z-0905-2025.

June 24, 2025 — FDA Import Alert 89-04. 58 Olympus device models blocked from U.S. entry — Aizu facility, 21 CFR Part 820 noncompliance.

October 14—17, 2025 — Olympus Urgent Field Safety Notice. 2 confirmed deaths, 5 serious injuries. Prior protocols admitted insufficient. 10x magnification now required.

March 2026 — Health Canada Recall. MAJ-1443 and MAJ-1444 valve accessories — most recent global regulatory action as of sprint launch.

The legal argument: Olympus — not the hospitals — was responsible for providing safe cleaning instructions. Hospitals followed those instructions exactly. Olympus later admitted failing to file the required adverse-event reports and continued distributing defective devices.

Who Qualifies to File an Olympus Scope Lawsuit?

The confirmed intake criteria for the Marin & Murphy co-counsel agreement are: procedure date on or after January 1, 2015; Olympus bronchoscope, upper GI endoscope, or colonoscope; confirmed infection diagnosis; inpatient hospitalization for the infection; IV antibiotic treatment during hospitalization; infection within 30 days of the scope procedure; and no active dialysis, chemotherapy, or abdominal procedure/implant in the 30 days before the scope procedure.

Outpatient treatment with oral antibiotics alone does not qualify. Device disintegration cases are IN with no 30-day window. HIV and TB cases qualify when all other criteria are met.

Statute of limitations: Tennessee — 1 year (highest urgency). Rhode Island — 3 years. South Carolina — 3 years. Most states — 2—3 years. Even patients who believe their deadline has passed should contact an attorney before assuming they have no options.

What Infections Are Linked to Contaminated Olympus Scopes?

The most serious infections linked to contaminated Olympus scopes are carbapenem-resistant organisms — bacteria that have evolved resistance to carbapenems, the antibiotic class used as a treatment of last resort for gram-negative infections. Carbapenem-Resistant Enterobacteriaceae (CRE) bloodstream infections are associated with mortality rates approaching 50%, according to the CDC. (Source: CDC MMWR Vital Signs, March 5, 2013.) When CRE is transmitted through a contaminated scope, the receiving patient faces odds that would not exist without the device defect.

The most virulent CRE subtype in this litigation is NDM-producing organisms — bacteria carrying the New Delhi metallo-beta-lactamase gene. NDM bacteria are resistant to nearly all available antibiotics, including the last-resort agents colistin and tigecycline. The 2013 Illinois teaching-hospital outbreak was caused by NDM-producing E. coli. In that outbreak, exposure to a duodenoscope was associated with an odds ratio of 78 (95% CI, 6.0–1008) (Epstein et al., 2014). Patients in this litigation who developed NDM infections are in the highest case value tier.

Other qualifying infections include Extended-Spectrum Beta-Lactamase (ESBL)-producing Klebsiella and E. coli, Vancomycin-Resistant Enterococcus (VRE), Methicillin-Resistant Staphylococcus aureus (MRSA), non-resistant Klebsiella pneumoniae, and Pseudomonas aeruginosa. The infection must have been confirmed by culture and must meet the 30-day window requirement. Standard community-acquired organisms that happen to appear after a scope procedure, without matching the outbreak pathogen or facility pattern, are evaluated individually — qualification depends on the facts of each case.

HIV and tuberculosis infections transmitted through contaminated scopes also qualify. Both are evaluated individually, and qualify when all standard intake criteria are met.

Patients who developed infections requiring last-resort antibiotics — colistin, tigecycline, polymyxins — are among the most serious cases in this litigation, because these organisms are the most dangerous, the treatment is the most severe, and the causal story (no other exposure pathway) is the most straightforward.

What Is the Olympus MAJ-891 Recall?

The Olympus MAJ-891 Forceps/Irrigation Plug is an accessory used during endoscopic procedures that attaches to the working channel of the scope. In December 2024, the FDA issued a Class I recall — its most serious category — covering 30,140 MAJ-891 units distributed in the United States between October 2016 and July 2024. Reports associated with this device include 120+ injuries and at least 1 confirmed death. The recall was assigned FDA Recall No. Z-0905-2025. (Source: FDA, accessdata.fda.gov, Recall No. Z-0905-2025.)

The MAJ-891 defect — potential inadvertent retention of biomaterial that prevents complete removal during reprocessing — is directly relevant to the broader contamination mechanism theory. The MAJ-891 attaches to the working channel through which instruments are passed into the patient. If biomaterial accumulates in the plug and cannot be fully removed during reprocessing, that material can be introduced directly into the next patient’s bloodstream through the contaminated channel. This is not a theoretical risk — it is the documented failure mode that triggered a Class I recall with confirmed injuries and a death.

The MAJ-891 recall matters for intake in two ways. First, patients who underwent procedures where the MAJ-891 was in use — identifiable through facility device records — may have a direct device-level causation argument tied to the specific recalled unit, not just the scope model. Second, the recall reinforces the broader design defect argument: Olympus repeatedly failed to design accessories that could be safely reprocessed, and this pattern of failure across multiple device lines supports the punitive damages and knowledge arguments in the litigation.

How Much Is an Olympus Scope Lawsuit Worth?

Olympus scope lawsuit values are determined by injury severity and fall into five confirmed tiers based on litigation strategy documentation as of April 2026. For a detailed breakdown of each tier and the factors that affect value, see the complete settlement value guide.

Standard qualifying case: The minimum expected value for a clean qualifying case — confirmed procedure on or after January 1, 2015, confirmed infection, inpatient hospitalization, and IV antibiotic treatment, with full recovery.

Typical qualifying case: The expected range for most qualifying cases — a 3—5 day hospitalization with a confirmed infection and full or near-full recovery.

Serious injury tier: Cases involving serious injury, organ damage, extended ICU stays, or infections requiring last-resort antibiotics such as colistin or tigecycline.

Wrongful death tier: Cases where the patient died from, or with a meaningful contribution from, the scope-related infection. Causation does not require that the infection was the sole cause of death — a contributing cause is sufficient.

Catastrophic injury tier: Cases where the patient sustained permanent, life-altering disability as a result of the infection — including patients who can no longer walk or perform basic daily functions.

The Bigler verdict awarded $6.6 million to Virginia Mason for the hospital’s own losses and $1 million to the patient’s family — not a patient award, and not a benchmark for individual claims. Individual settlement amounts in co-counsel agreement cases are confidential and are not cited here.

Several features distinguish the Olympus litigation from typical mass tort product-liability matters. Olympus Medical Systems Corporation pleaded guilty in 2018 to distributing misbranded medical devices and paid an $85 million criminal penalty. Whether and how that record affects available defenses, causation analysis, or recovery from any corporate restructuring is determined case-by-case by the court applying the relevant law to the facts of each matter.

What Is the Current Status of the Olympus Scope Litigation?

As of April 2026, no Olympus scope MDL has been filed. The JPML docket does not list any pending Olympus scope consolidation petition. However, individual cases are proceeding in federal and state courts — a litigation strategy in which multiple law firms simultaneously file cases in a targeted federal district to build the volume of individual cases.

Because these cases proceed as individual lawsuits, timelines vary by case and jurisdiction. Total timeline from now: 2—5 years.

Approximately 500,000 to 650,000 ERCPs are performed annually in the United States using Olympus devices — the procedures most commonly linked to confirmed infection outbreaks in this litigation. The scale of potential exposure and the volume of qualifying cases have generated significant individual litigation against Olympus. No MDL has been filed, and the outcome of any individual case cannot be predicted. (Source: FDA Safety Communication, February 2015; confirmed procedure volume data.)

What Should I Do If I Think I Have an Olympus Scope Claim?

If you had a procedure with an Olympus scope on or after January 1, 2015, and developed an infection within 30 days that required inpatient hospitalization and IV antibiotic treatment, here are the six steps to take now.

1. Check your procedure records. Confirm the type of scope used, the date of the procedure, and the hospital or facility. Your medical records will contain this information under the procedure report or operative note.
2. Request your infection records. Get the records documenting the infection diagnosis, the hospital admission, and the antibiotic treatment. The culture report identifying the specific organism is particularly valuable.
3. Calculate your filing deadline. Your statute of limitations runs from the date of your injury — not a consolidated-proceeding date. Tennessee patients have one year. Most other states: two to three years. If you are unsure of your deadline, assume it is sooner than you think and act accordingly.
4. Contact an attorney immediately if you are in Tennessee. Tennessee’s one-year statute of limitations is the shortest in the litigation. Patients who were infected in 2025 may already be approaching their deadline. There is no exception to a state’s statute of limitations for any future consolidated proceeding.
5. Preserve all documentation. Do not discard any medical records, hospital bills, insurance statements, or communications from the hospital about your procedure. If you received a hospital exposure letter, preserve it.
6. Contact Marin & Murphy for a free case evaluation. We will review your records, confirm whether your situation meets the intake criteria, and advise you on your specific filing deadline. Call (888) 348-2735 today.

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Attorney Advertising. This page is general information, not legal advice, and does not create an attorney-client relationship — that relationship is formed only by a signed written agreement. The attorneys of Marin & Murphy Law Firm are licensed in Rhode Island, South Carolina, Connecticut, and Massachusetts. We evaluate potential claims nationwide; for matters arising in states where our attorneys are not admitted, we associate with or refer to locally licensed co-counsel and do not ourselves practice law in those jurisdictions.

Submitting the contact form or contacting the firm does not create an attorney-client relationship. Representation is offered on a contingent-fee basis: no fee unless there is a recovery, though a client may be responsible for case costs and expenses. The statute of limitations may sharply limit the time to file a claim. Prior results do not guarantee a similar outcome, and no outcome is guaranteed. Responsible attorney: Matthew T.

Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.

Marin, Marin & Murphy Law Firm (Rhode Island).