Olympus Scope — Infection Litigation
The Olympus Scope Infection Litigation, Explained
Olympus pleaded guilty in federal court to failing to report scope infections — $85 million in penalties, 250+ patients affected. Here is what is publicly known.
ACTIVE LITIGATION. Most recent filing: June 2026 · deadlines vary by state — some as short as one year.
Marin & Murphy is not licensed in Washington; details below.
Stefanie A. Murphy & Matthew T. Marin
Partners
Super Lawyers® honorees · members of the American Association for Justice · concentrating in personal injury and mass-tort litigation.
Whether any individual has a claim depends on their medical records and the law of their state. The information below covers the litigation itself.
Virginia Mason Medical Center in Seattle, Washington state was named in the U.S. Senate HELP Committee report as one of the U.S. hospitals named in a national outbreak linked to contaminated Olympus duodenoscopes. Washington state patients have legal rights against Olympus — not Virginia Mason — but Washington state has a three-year filing deadline. If you had a scope procedure at Virginia Mason and developed an infection, the time to act is now.
7
Hospitals Named by U.S. Senate
250+
Patients Infected Worldwide
$85M
Olympus Guilty Plea Penalty — DOJ 2018
3 Years
WA SOL — Filing Deadline
⚠ WA PATIENTS: YOUR RIGHT TO FILE IS TIME-LIMITED
Washington state has a three-year statute of limitations for personal injury claims. Consult an attorney promptly to preserve your rights.
Important: Virginia Mason is not the defendant. The device manufacturer — Olympus Corporation — is the subject of pending litigation. Virginia Mason reported following the cleaning instructions provided by Olympus at the relevant time. Whether those instructions were adequate, and whether they were in fact followed in every case, are contested issues that have been examined in litigation and in 2016 Senate HELP Committee findings.
Plaintiffs allege that liability runs to Olympus for supplying defective scopes and inadequate reprocessing instructions, and for failing to report contamination knowledge to the FDA. In December 2018, Olympus pleaded guilty and paid $85 million in federal penalties.
What Did the Senate Investigation Find About Virginia Mason Medical Center?
In January 2016, the U.S. Senate Health, Education, Labor, and Pensions Committee published “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.” The report named Virginia Mason Medical Center in Seattle, Washington state as one of the U.S. hospitals that experienced outbreaks of carbapenem-resistant bacterial infections linked to contaminated Olympus duodenoscopes. (Source: Senate HELP Committee, January 13, 2016.) Between November 2012 and August 2013, Virginia Mason Medical Center performed 1,149 ERCP procedures using Olympus duodenoscopes.
During that period, 32 patients developed confirmed infections with multidrug-resistant E. coli (MDR E. coli). Seven patients died within 31 days of a confirmed positive culture; 16 deaths were documented in total by March 2015 (Ross et al., Gastrointestinal Endoscopy, 2015). Examining the broader outbreak, the U.S. Senate HELP Committee reported 32 patients infected with CRE plus 7 with E. coli, and at least 18 outbreak-associated deaths.
Researchers examined 8 Olympus duodenoscopes used during the outbreak period — MDR E. coli was recovered directly from 4 of the 8 scopes, a 50-percent culture-positive rate. Three of the eight scopes also required critical mechanical repairs, despite showing no visible malfunction. The peer-reviewed study’s conclusion was unambiguous: existing manufacturer-recommended high-level disinfection protocols for duodenoscopes “are inadequate.” (Source: Ross et al., Gastrointest Endosc, 2015, PMID 26092616.) The committee estimated that at least 250 patients worldwide contracted potentially deadly infections from contaminated Olympus duodenoscopes — and stated this figure is likely a significant undercount, because many scope-related infections are never linked to a procedure that occurred days or weeks earlier.
The committee concluded that Olympus was aware of contamination problems years before issuing public warnings and that FDA oversight of medical device safety was inadequate. Across the U.S. hospitals named in the Senate HELP Committee report, contamination occurred even where hospitals reported following Olympus’s reprocessing instructions — a pattern plaintiffs attribute to the duodenoscope’s elevator-channel design rather than to hospital error.
Yet standard high-level disinfection leaves approximately a significant share of patient-ready duodenoscopes contaminated with gastrointestinal bacteria even when staff follow manufacturer instructions to the letter. (Source: Larsen S, et al., EClinicalMedicine. 2020;25:100451. PMID: 32954234.) Washington state patients have three years from injury to act.
What Did Olympus Know Before the National Outbreaks Were Made Public?
Virginia Mason Medical Center notified Olympus directly during the outbreak in 2012–2013. Olympus did not issue a public recall or warning to other U.S. hospitals. Patients undergoing ERCP procedures at other facilities had no way of knowing that an identical contamination risk existed in their own hospitals. By 2012 and 2013, Olympus was already aware of similar contamination events at European hospitals and had not warned U.S. facilities.
(Source: Ross et al., PMID 26092616; DOJ press release.) The full extent of Olympus’s failure to report became a matter of public record in December 2018. Olympus Medical Systems Corporation and former senior executive Hisao Yabe pleaded guilty to three counts of distributing misbranded medical devices. (Case No. 2:18-cr-00727-SRC, U.S. District Court, District of New Jersey.) The company paid $85 million in penalties during the outbreak period when the national outbreaks occurred.
(Source: DOJ press release, December 10, 2018.) In October 2025, Olympus issued an Urgent Field Safety Notice admitting that prior reprocessing protocols for current-generation TJF-series duodenoscopes — the TJF-Q190V, TJF-Q290V, and TJF-Q170V — were insufficient — and that hospitals were now required to use 10X magnification inspection tools never previously required. The notice confirmed 2 deaths and 5 serious injuries linked to current-generation TJF duodenoscopes.
(Source: Olympus Urgent Field Safety Notice, October 14–17, 2025.) This admission applies retroactively to every ERCP performed at Virginia Mason before October 2025. The legal argument is direct: Olympus supplied the scopes. Olympus wrote the cleaning instructions. Virginia Mason followed those instructions. Olympus had prior knowledge of contamination events across multiple U.S. and European hospitals and failed to report that knowledge from regulators and from the hospitals using its devices.
Plaintiffs allege that liability runs to the manufacturer — not to the hospital that used the equipment as directed.
Why Washington State Patients Must Act Now
Washington State SOL ALERT: 3 Years — Filing Deadline
Washington state has a three-year statute of limitations for personal injury claims. Consult an attorney promptly to preserve your rights.
Washington state has a three-year statute of limitations for personal injury claims. The circumstances of each individual case affect how that deadline is calculated — including when the injury was first discovered and when a connection to a scope procedure was or reasonably should have been made. Do not attempt to self-determine a filing deadline without consulting an attorney. Even if you believe your window may have passed, consult an attorney before concluding you have no options.
Patients who received a letter from Virginia Mason Medical Center or another Washington hospital notifying them of a potential device-related patient safety event should treat that letter as time-sensitive evidence. It documents the hospital’s acknowledgment of a potential device-related patient safety event — relevant evidence in a claim against Olympus. Preserve that letter. The device manufacturer — Olympus Corporation — is the subject of pending litigation.
Virginia Mason is not the defendant.
Do You Qualify? Confirming Your Potential Claim
This litigation has confirmed intake criteria. Review the checklist below. If your situation matches, consult a qualified attorney promptly — Washington state’s three-year deadline means every day matters.
You may qualify if ALL of the following apply:
✓ Procedure date: On or after January 1, 2015
✓ Device used: Olympus duodenoscope, bronchoscope, or upper GI endoscope
✓ Infection confirmed: By culture or laboratory report
✓ Hospitalized: Inpatient admission required
✓ IV antibiotics: Administered during hospitalization
✓ Timeline: Infection and hospitalization within 30 days of scope procedure
✓ Wrongful death: Accepted if loved one died from a qualifying infection
✓ Sepsis or organ failure arising from the scope procedure also qualifies
Qualifying infection types include:
- Carbapenem-Resistant Enterobacteriaceae (CRE)
- NDM-1-producing E. coli
- ESBL-producing organisms
- Klebsiella pneumoniae
- Pseudomonas aeruginosa
- VRE
- MRSA
- Sepsis (with hospitalization + IV antibiotics within 30 days)
CRE bloodstream infections are associated with mortality rates approaching 50% per CDC data (CDC MMWR Vital Signs, March 5, 2013). HIV and tuberculosis infections transmitted through contaminated scopes are evaluated individually and may qualify. Device disintegration during procedure is a separate product liability theory, which is worth discussing with a qualified attorney.
What Should You Do Right Now?
If you are a Washington state patient, you have three years to act. Complete these five steps — starting today.
1
Call an attorney before anything else.
Washington state’s three-year statute of limitations means your first call should be to a mass tort attorney — not to Virginia Mason.
2
Preserve the hospital exposure letter.
A formal notification from Virginia Mason or any Washington hospital documenting a potential device-related patient safety event is relevant evidence in a product liability claim against Olympus. Keep all correspondence relating to your procedure and any scope-related follow-up. Do not discard it.
3
Request your medical records.
You will need: the procedure record identifying the specific Olympus scope model and serial number; infection or diagnosis records; hospitalization records; and culture or laboratory reports identifying the organism responsible for your infection. Your attorney can help you obtain these.
4
Do NOT contact Virginia Mason’s risk management.
Risk management represents the hospital’s interests — not yours. Any statements you make to hospital risk management may be used to limit or defeat your claim. Speak to an attorney before making any contact.
5
Do NOT sign any release, waiver, or settlement document.
Signing any document without attorney review could permanently extinguish your legal rights. Do not sign anything relating to your scope procedure or resulting infection without speaking to a mass tort attorney first.
Frequently Asked Questions
Was Virginia Mason Medical Center responsible for the infection outbreak?
Virginia Mason reported following Olympus’s reprocessing instructions provided at the relevant time, and the peer-reviewed study found no breach in the hospital’s disinfection protocol. The instructions themselves were inadequate, and Olympus provided those instructions. The device manufacturer Olympus — not the hospital — is the subject of pending litigation. Virginia Mason was the site of the outbreak but not the source of the failed cleaning guidance.
How many patients were infected at Virginia Mason?
32 patients were confirmed infected with MDR E. coli; 7 died within 31 days of a confirmed positive culture, and 16 had died in total by March 2015 (Ross et al., PMID 26092616). A broader investigation reported 18 total outbreak-associated deaths. The tiered figures reflect different data sources and time periods — each is accurate to its cited source.
What bacteria caused the Virginia Mason outbreak?
The outbreak pathogen was multidrug-resistant E. coli (MDR E. coli), confirmed by Ross et al. in Gastrointestinal Endoscopy (September 2015, PMID 26092616). MDR E. coli is highly resistant to standard antibiotic treatments, making post-procedure infections especially dangerous. The organism was recovered from 4 of the 8 Olympus duodenoscopes tested, confirming the scopes as the transmission vector.
I had an ERCP at Virginia Mason between 2012 and the present — what should I do?
Preserve any exposure letter from the hospital, request your procedure and infection records including scope model and serial number, and consult a mass tort attorney before attempting to calculate your own filing deadline. Washington state has a three-year statute of limitations for personal injury claims; how it applies depends on your specific circumstances. Do not assume your time has run without speaking to an attorney first.
Did the cleaning protocols Virginia Mason used actually work?
No — 4 of 8 Olympus duodenoscopes tested positive for MDR E. coli., PMID 26092616). Virginia Mason reported following the manufacturer instructions provided by Olympus at the relevant time, and the scopes were nonetheless found contaminated. Whether those instructions were adequate, and whether they were in fact followed in every case, are contested issues that have been examined in litigation and in 2016 Senate HELP Committee findings.
A 2022 meta-analysis confirmed that even enhanced protocols leave 5 percent of scopes contaminated (Bomman et al., PMC8831410). The protocols were inadequate, not misapplied.
Can I still file a lawsuit if the Virginia Mason outbreak happened years ago?
Whether you can file depends on factors specific to your situation — when you were diagnosed, when you received an exposure letter, and the applicable statute of limitations. Do not self-disqualify based on the passage of time. Even if you believe your filing deadline has passed, consult an attorney before assuming you have no options; depending on how a potential global resolution is structured, there may still be options worth exploring.
What is Olympus Corporation’s legal responsibility in the Virginia Mason outbreak?
Olympus supplied the scopes, wrote the cleaning instructions, was notified of the Virginia Mason outbreak directly, and did not warn other U.S. hospitals. In December 2018, Olympus pleaded guilty to distributing misbranded medical devices and paid $85 million, admitting it failed to report adverse event data from the FDA (DOJ press release; Case No. 2:18-cr-00727-SRC). In October 2025, Olympus admitted prior reprocessing protocols were insufficient — an acknowledgment that applies retroactively to all pre-2025 ERCP procedures.
How do I know if an Olympus scope was used during my Virginia Mason procedure?
Request the procedure record from Virginia Mason — it should identify the scope model and serial number used during your ERCP or other endoscopic procedure. If the records do not clearly identify the device, an attorney can assist in obtaining and interpreting your complete medical file. The scope model and serial number link your procedure to the recalled or flagged devices at the center of this litigation.
Sources — Click to expand
- U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee. “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.” January 13, 2016.
- Ross AS, Baliga C, Verma P, Duchin J, Gluck M. Gastrointest Endosc. 2015 Sep;82(3):477-83. PMID 26092616.
- Epstein L, Hunter JC, Arwady MA, et al. JAMA. 2014;312(14):1447-1455. PMID 25291580.
- Humphries RM, Yang S, Kim S, et al. Clin Infect Dis. 2017 Oct 1;65(7):1159-1166. PMID 29579235.
- U.S. Department of Justice. Press Release. Olympus Corporation and Executive pleaded guilty. December 10, 2018.
- Olympus Corporation. Urgent Field Safety Notice: TJF-Q190V, TJF-Q290V, TJF-Q170V Duodenoscopes. October 14-17, 2025. (on file)
- U.S. Food and Drug Administration. Safety Communication: Design of Olympus Duodenoscopes and Potential Risks of Infection. February 19, 2015.
- U.S. Food and Drug Administration. Recall No. Z-0905-2025 (MAJ-891 Forceps/Irrigation Plug). December 2024.
- U.S. Food and Drug Administration. Import Alert 89-04: Detention Without Physical Examination of Olympus Medical Devices. June 24, 2025.
- Bomman S, Bhatt A, Bhurwal A, et al. Clinical Endoscopy. January 2022. PMC8831410.
- Larsen S, Russell RV, Ockert LK, Spanos S, Travis HS, Ehlers LH, Mærkedahl A. Rate and impact of duodenoscope contamination: A systematic review and meta-analysis. EClinicalMedicine. 2020 Jul 15;25:100451. doi:10.1016/j.eclinm.2020.100451. PMID: 32954234. PMCID: PMC7486302.
- van der Ploeg K, et al. Gut. 2024;73(4):613-621. PMID 38182137.
- Case No. 2:18-cr-00727-SRC. U.S. District Court, District of New Jersey. Filed December 10, 2018.
- CDC MMWR Vital Signs. Carbapenem-Resistant Enterobacteriaceae. March 5, 2013.
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.
Attorney Advertising. Marin & Murphy Law Firm is licensed in Rhode Island, South Carolina, Connecticut, and Massachusetts. This page is provided for informational purposes for residents of Washington state. If you are located in Washington state, we can discuss your situation and help connect you with qualified representation. Prior results do not guarantee a similar outcome.
A June 2026 Washington wrongful-death filing, Bruto Da Costa v. Olympus (W.D. Wash.), is among the most recent Olympus duodenoscope cases — see the Olympus scope lawsuit overview for details.
Related Olympus scope lawsuit resources
- The Olympus scope contamination case explained
- Tennessee scope infection claims
- A recent Olympus duodenoscope case
- Postmarket reporting failures
- The Urgent Field Safety Notice explained
- What the FDA warning letters said
- Olympus’s federal criminal record
- Hospital notified you of possible exposure
- The duodenoscope elevator mechanism
- Infections linked to colonoscopes
- Carbapenem-resistant infections from scopes
- ERCP scope infection claims
- New York scope infection claims
- MAUDE adverse-event reports for Olympus scopes
- Class I recall of the MAJ-891
- What scope infection cases may be worth
- Olympus scope lawsuit — the full guide
Attorney Advertising. Marin & Murphy Law Firm is licensed only in Rhode Island, South Carolina, Connecticut, and Massachusetts, and is not licensed to practice law in Washington. This page is provided for general informational purposes only. It is not legal advice, does not create an attorney-client relationship, and does not constitute an offer to represent any Washington resident. Prior results do not guarantee a similar outcome.
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Marin & Murphy Law Firm attorneys are licensed in Rhode Island, Connecticut, Massachusetts, and South Carolina. We are not licensed in Washington. The firm does not accept Washington legal matters; inquiries from Washington residents are referred to attorneys licensed in Washington. This page is attorney advertising and is provided for general information; it is not legal advice, and reading it does not create an attorney–client relationship.