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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 Pennsylvania; details below.

Attorneys Stefanie A. Murphy and Matthew T. Marin of Marin & Murphy Law Firm

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.

UPMC Presbyterian Hospital in Pittsburgh, Pennsylvania was named in the U.S. Senate HELP Committee report as one of the U.S. hospitals in a national outbreak linked to contaminated Olympus duodenoscopes. The UPMC outbreak — approximately 13 patients infected in fall 2012 — was among the earliest confirmed domestic CRE outbreaks linked to Olympus scopes, and an evaluation by Olympus together with the outside consulting group ECRI Institute reported that UPMC’s reprocessing was consistent with manufacturer recommendations — though ECRI could not definitively assess whether a defect within the endoscope provided a reservoir for bacteria. Pennsylvania patients have legal rights against Olympus — not UPMC — but Pennsylvania has a two-year filing deadline. If you had a scope procedure at UPMC Presbyterian and developed an infection, the time to act is now.

7

Hospitals Named by U.S. Senate

250+

Patients Infected Nationally

$85M

Olympus Guilty Plea Penalty — DOJ 2018

2 Years

PA SOL — Filing Deadline

⚠  PA PATIENTS: YOUR RIGHT TO FILE IS TIME-LIMITED

Pennsylvania has a two-year statute of limitations for personal injury claims. Consult an attorney promptly to preserve your rights.

Free Confidential Evaluation —

(888) 348-2735

Available 24/7  ·  We can evaluate your situation and connect you with qualified representation in Pennsylvania

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.

Important: UPMC Presbyterian Hospital is not the defendant. The device manufacturer — Olympus Corporation — is the subject of pending litigation. An evaluation by Olympus together with the outside consulting group ECRI Institute reported that UPMC’s reprocessing was consistent with standard practice and manufacturer recommendations. The liability runs to Olympus for supplying defective scopes and inadequate reprocessing instructions, and for failing to report contamination information to the FDA. In December 2018, Olympus pleaded guilty and paid $85 million in federal penalties.

What Did the Senate Investigation Find About the Pittsburgh-Area Outbreak?

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 UPMC Presbyterian Hospital as one of the U.S. hospitals that experienced outbreaks of carbapenem-resistant bacterial infections linked to contaminated Olympus duodenoscopes. The committee concluded that Olympus and other manufacturers were aware of contamination problems years before issuing warnings and that federal oversight of device safety was inadequate to protect patients. (Source: Senate HELP Committee, January 13, 2016.) The Senate report addresses UPMC Presbyterian Hospital in particular detail.

In fall 2012, approximately 13 patients contracted CRE infections following ERCP procedures with Olympus duodenoscopes — one of the earliest confirmed domestic outbreaks of its kind. Olympus was directly notified in November 2012. ECRI Institute independently evaluated UPMC’s reprocessing procedures and confirmed they were “consistent with standard practice and manufacturer recommendations” — the same finding documented at every other named facility.

UPMC subsequently purchased an Olympus AER — Olympus’s own proprietary reprocessing machine — and demonstrated that contamination persisted even through Olympus’s own equipment. Olympus filed a Medical Device Report on December 18, 2012 documenting the UPMC events; that report appears to have never been entered into the FDA’s adverse event database. (Source: Senate HELP Committee, January 13, 2016.) The committee estimated that at least 250 patients worldwide contracted potentially deadly infections from contaminated duodenoscopes, across all three manufacturers and stated this figure was likely a significant undercount.

The central finding was that Olympus had failed to report contamination events to federal regulators during the period when these outbreaks were occurring. (Source: Senate HELP Committee, January 13, 2016.) Peer-reviewed records from other hospitals confirm the national scale. At Virginia Mason Medical Center in Seattle, 32 patients contracted multidrug-resistant E. coli over nine months; seven died within 31 days, and four of eight Olympus duodenoscopes tested culture-positive — no breach in the hospital’s disinfection protocol was identified. (Source: Ross et al., PMID 26092616.) At an Illinois teaching hospital, 39 patients contracted NDM-producing E. coli, with an odds ratio of 78 (95% CI, 6.0–1008) for ERCP patients.

(Source: Epstein et al., PMID 25291580.) At Ronald Reagan UCLA Medical Center, 17 patients were infected, 2 died, and approximately 179 were potentially exposed — with no identified deviation from manufacturer recommendations. (Sources: Humphries et al., PMID 29579235.) An 8-year retrospective study published in Gut found that 94.7% of patient-ready scopes showed measurable bacterial contamination, and that all manufacturer-recommended interventions — new reprocessing machines, disposable endcap designs, and staff audits — failed to produce a meaningful contamination reduction.

(Source: van der Ploeg et al., PMID 38182137.) Pennsylvania patients have two years from injury to act.

What Did Olympus Know Before These Outbreaks Were Made Public?

By January 2016, Olympus had already been directly notified of outbreaks at UPMC Presbyterian Hospital (November 2012), Virginia Mason (2012–2013), the Illinois teaching hospital (2013), and UCLA (2014–2015), and was aware of contamination events at European hospitals linked to the same device design as early as 2012. The UPMC Presbyterian notification was among the earliest Olympus received from a domestic facility — and came before the Virginia Mason and the Illinois teaching hospital outbreaks became publicly documented. Olympus issued no public recall and provided no general warning to U.S. hospitals during this entire period.

(Sources: Ross et al., PMID 26092616; Epstein et al., PMID 25291580; DOJ press release; Senate HELP Committee, January 13, 2016.) The UPMC Presbyterian events are particularly significant to the corporate knowledge timeline. When Olympus was notified in November 2012, its investigators raised questions about whether UPMC’s Custom Ultrasonics automated endoscope reprocessors might be responsible for the contamination.

UPMC answered by purchasing an Olympus AER — Olympus’s own proprietary reprocessing equipment — and demonstrating that contamination persisted through Olympus’s equipment as well. Olympus responded by filing a Medical Device Report on December 18, 2012. That MDR appears to have never been entered into the FDA’s MAUDE adverse event database, leaving federal regulators without documented knowledge of one of the country’s earliest confirmed duodenoscope-linked CRE outbreaks.

(Source: Senate HELP Committee, January 13, 2016.) In December 2018, that silence became a matter of federal criminal record. 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.) Olympus paid an $85 million fine and admitted failing to file FDA-required adverse-event reports during the period when these outbreaks were occurring.

(Source: DOJ press release, December 10, 2018.) In October 2025, Olympus issued an Urgent Field Safety Notice for its current-generation TJF-series duodenoscopes, admitting that prior reprocessing protocols were insufficient and that hospitals were now required to use 10× magnification tools during visual inspection — a requirement its prior instructions had never imposed. The company linked the notice to two confirmed deaths and five serious injuries.

(Source: Olympus Urgent Field Safety Notice, October 14–17, 2025.) This admission applies retroactively to procedures performed under those prior protocols, including those at UPMC Presbyterian Hospital.

Why Pennsylvania Patients Must Act Now

Pennsylvania SOL ALERT: 2 Years — Filing Deadline

Pennsylvania has a two-year statute of limitations for personal injury claims. Consult an attorney promptly to preserve your rights.

Pennsylvania has a two-year statute of limitations for personal injury claims. The deadline may run from the date of your procedure, the date you received the exposure letter, or the date you discovered the injury was connected to the scope — depending on how Pennsylvania’s discovery rule applies to your individual circumstances. Because the timing rules are fact-specific, consult an attorney promptly rather than waiting and potentially forfeiting your options.

If you received a letter from UPMC Presbyterian Hospital regarding a potential risk related to a scope procedure, preserve it — it documents the hospital’s acknowledgment of a potential device-related patient safety event. When Olympus issued its October 2025 Urgent Field Safety Notice, facilities that had used the affected TJF-series duodenoscopes were required to notify patients who underwent procedures with those devices.

The letter is the hospital’s documented acknowledgment — created under a federal regulatory obligation — that your procedure, the Olympus device, and the contamination risk are connected. Preserve that letter. UPMC Presbyterian Hospital is not the defendant. The device manufacturer — Olympus Corporation — is the subject of pending litigation. Do not assume you have no options without first consulting an attorney. Even if you believe your filing deadline may have passed, contact us before concluding — the discovery rule may apply to your situation.

Do You Qualify? Confirming Your Potential Claim

This litigation has confirmed intake criteria. Review the checklist below. If your situation matches, contact us immediately — Pennsylvania’s two-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:

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 — contact us to discuss.

Not sure if you qualify? We’ll evaluate your situation for free.

(888) 348-2735

No fee unless there is a recovery  ·  Available 24/7  ·  Pennsylvania patients: we can connect you with qualified representation

Notice of exposure? If you received a notice of exposure after an Olympus scope procedure, you may qualify even without a confirmed infection diagnosis — contact us to review your situation.

What Should You Do Right Now?

If you are a Pennsylvania patient, you have two years to act. Complete these five steps — starting today.

1

Call an attorney before anything else.

Pennsylvania’s two-year statute of limitations means your first call should be to a mass tort attorney — not to UPMC Presbyterian. Call (888) 348-2735 for a free, confidential evaluation. We can assess your situation and connect you with qualified representation in Pennsylvania.

2

Preserve the hospital exposure letter.

A formal notification from UPMC Presbyterian Hospital documenting a potential device-related patient safety event is the hospital’s own documented acknowledgment — created under a federal regulatory obligation — that your procedure, the Olympus device, and the contamination risk are connected. Store it safely and do not discard it.

3

Request your medical records.

Ask for the procedure record identifying the Olympus scope model and serial number, your infection or diagnosis records, hospitalization records, and culture or lab reports identifying the specific organism. Your attorney can assist you in obtaining these if you have difficulty.

4

Who Does the Hospital’s Risk Management Team Represent?

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.

Any document the hospital or its insurer presents should be reviewed by your own attorney before you sign. Signing without attorney review could permanently extinguish your legal rights — including claims against Olympus that you did not intend to give up.

Frequently Asked Questions

Was a Pittsburgh hospital named in the Senate investigation into Olympus scope infections?

Yes. The Senate HELP Committee’s January 13, 2016 report named UPMC Presbyterian Hospital as one of the U.S. hospitals that experienced outbreaks of carbapenem-resistant infections linked to contaminated Olympus duodenoscopes. UPMC was among the first U.S. hospitals to notify Olympus directly — it did so in November 2012. The report estimated at least 250 patients worldwide, across all three duodenoscope manufacturers, contracted potentially deadly infections — a figure the committee described as a likely significant undercount.

Which Pittsburgh hospital was named in the Senate report?

UPMC Presbyterian Hospital in Pittsburgh was named in the Senate HELP Committee’s report as the site of an outbreak in fall 2012, in which approximately 13 patients contracted CRE infections following ERCP procedures with Olympus duodenoscopes. ECRI Institute independently evaluated UPMC’s reprocessing procedures and confirmed they were consistent with standard practice and manufacturer recommendations — the same finding documented at every other named facility in the investigation.

Patients who had ERCP procedures at UPMC Presbyterian Hospital and developed subsequent infections should contact an attorney to evaluate their records.

How many patients were affected at the Pittsburgh hospital?

The Senate HELP Committee confirmed approximately 13 patients at UPMC Presbyterian Hospital contracted CRE infections in fall 2012 following ERCP procedures with Olympus duodenoscopes. The committee estimated at least 250 patients worldwide, across all three duodenoscope manufacturers — a figure it stated was likely a significant undercount. UPMC Presbyterian Hospital was confirmed in the Senate investigation as a documented outbreak site; do not discount a potential claim based on the time elapsed since the procedure.

What bacteria caused the Pittsburgh scope outbreak?

The Senate HELP investigation linked the Pittsburgh-area outbreak to carbapenem-resistant bacterial infections — the same class of antibiotic-resistant superbugs documented at Virginia Mason, Ronald Reagan UCLA, and the Illinois teaching hospital. CRE bloodstream infections are associated with mortality rates approaching 50 percent per CDC data. Other organisms documented in Olympus duodenoscope outbreaks include NDM-1-producing E. coli, ESBL-producing organisms, and carbapenem-resistant Klebsiella pneumoniae.

I had an ERCP at UPMC Presbyterian Hospital — what should I do?

If you had an ERCP at UPMC Presbyterian Hospital — including during the fall 2012 period documented in the Senate HELP report, or at any time — preserve any exposure letter you received and request complete medical records, including the procedure record identifying the specific Olympus scope model and serial number and any infection or hospitalization records. Consult a mass tort attorney promptly — Pennsylvania’s two-year statute of limitations means delay affects your options.

Hospital risk management represents the hospital’s interests — not yours. Patients should be aware that statements made to the hospital or its representatives before consulting an attorney may affect their legal options.

Is UPMC Presbyterian Hospital the defendant in this litigation?

No. UPMC Presbyterian Hospital is not the defendant. Olympus Corporation — the device manufacturer — is the subject of pending litigation for supplying scopes with defective cleaning instructions and for failing to report contamination events to the FDA. Legal claims are directed at the manufacturer — not the facility that relied on its defective guidance. ECRI Institute confirmed that UPMC’s reprocessing was consistent with standard practice.

What is Olympus Corporation’s legal responsibility in the Pittsburgh outbreak?

Olympus supplied the duodenoscopes, wrote the inadequate reprocessing instructions, and had prior knowledge of outbreaks at multiple U.S. and European hospitals — with the UPMC notification arriving in November 2012 among the earliest. In December 2018, Olympus pleaded guilty to distributing misbranded medical devices and paid $85 million in federal criminal penalties. (Source: DOJ press release, December 10, 2018.) Olympus’s October 2025 Urgent Field Safety Notice admitted that prior reprocessing protocols for current-generation TJF-series scopes were insufficient — an admission that applies retroactively to procedures performed under those protocols.

Can I still file a lawsuit if my Pittsburgh procedure was several years ago?

Pennsylvania has a two-year statute of limitations for personal injury claims, but the discovery rule may extend the deadline where a patient did not know, and could not reasonably have known, that the injury was connected to the scope. Do not self-disqualify before speaking with an attorney. The applicable deadline depends on individual circumstances including when you received the exposure letter and when you connected the infection to the procedure.

Contact an attorney promptly — even if the deadline may have passed, there may still be options worth exploring.

Pennsylvania patients: your deadline may be closer than you think.

(888) 348-2735

Free confidential evaluation  ·  No fee unless there is a recovery  ·  Available 24/7 We can evaluate your situation and connect you with qualified representation in Pennsylvania.

Sources — Click to expand
  1. 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.
  2. Ross AS, Baliga C, Verma P, Duchin J, Gluck M. Gastrointest Endosc. 2015 Sep;82(3):477-83. PMID 26092616.
  3. Epstein L, Hunter JC, Arwady MA, et al. JAMA. 2014;312(14):1447-1455. PMID 25291580.
  4. Humphries RM, Yang S, Kim S, et al. Clin Infect Dis. 2017 Oct 1;65(7):1159-1166. PMID 29579235.
  5. U.S. Department of Justice. press release. Olympus Corporation and Executive Plead Guilty. December 10, 2018.
  6. Olympus Corporation. Urgent Field Safety Notice: TJF-Q190V, TJF-Q290V, TJF-Q170V Duodenoscopes. October 14-17, 2025. (on file)
  7. U.S. Food and Drug Administration. Safety Communication: Design of Olympus Duodenoscopes and Potential Risks of Infection. February 19, 2015.
  8. U.S. Food and Drug Administration. Recall No. Z-0905-2025 (MAJ-891 Forceps/Irrigation Plug). December 2024.
  9. U.S. Food and Drug Administration. Import Alert 89-04: Detention Without Physical Examination of Olympus Medical Devices. June 24, 2025.
  10. van der Ploeg K, Haanappel CP, Voor In ’t Holt AF, et al. Gut. 2024;73(4):613-621. PMID 38182137.
  11. Bomman S, Bhatt A, Bhurwal A, et al. Clinical Endoscopy. January 2022. PMC8831410.
  12. Case No. 2:18-cr-00727-SRC. U.S. District Court, District of New Jersey. Filed December 10, 2018.

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 Pennsylvania. If you are located in Pennsylvania, we can discuss your situation and help connect you with qualified representation. Prior results do not guarantee a similar outcome.

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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.

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

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 Pennsylvania. 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 Pennsylvania resident. Prior results do not guarantee a similar outcome.

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