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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 California; details below.

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

Stefanie A. Murphy & Matthew T. Marin

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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.

Cedars-Sinai Medical Center in Los Angeles, California was among the institutions at the center of the national Olympus duodenoscope contamination crisis. In 2015, Cedars-Sinai reported a CRE outbreak linked to Olympus scopes — 4 patients infected, approximately 71 patients notified. California patients have legal rights against Olympus — not Cedars-Sinai — but California has a two-year filing deadline. If you had a scope procedure at Cedars-Sinai 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

CA SOL — Filing Deadline

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

California 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 California

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: Cedars-Sinai Medical Center is not the defendant. The device manufacturer — Olympus Corporation — is the subject of pending litigation. Cedars-Sinai 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.

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 Happened at Cedars-Sinai 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 Cedars-Sinai Medical Center as part of the national network of hospitals where contaminated Olympus duodenoscopes caused or contributed to outbreaks of drug-resistant infection. (Source: Senate HELP Committee, January 13, 2016.) In March 2015, the Los Angeles County Department of Public Health issued a Board of Supervisors memo confirming that four patients at Cedars-Sinai Medical Center had developed carbapenem-resistant Enterobacteriaceae (CRE) infections following ERCP procedures at the facility. approximately 71 patients notified to contaminated Olympus duodenoscopes during those procedures.

(Source: LA County Department of Public Health, Board of Supervisors memo, March 10, 2015.) The Cedars-Sinai outbreak occurred simultaneously with a larger outbreak at nearby UCLA Ronald Reagan Medical Center, where 17 patients developed OXA-232 carbapenem-resistant Klebsiella pneumoniae infections, approximately 179 were potentially exposed, and two patients died. A federal and state field investigation found no deviation from FDA or manufacturer reprocessing recommendations at UCLA — hospital staff followed Olympus’s instructions precisely.

(Sources: Humphries et al., Clin Infect Dis, 2017, PMID 29579235 [17 patients, OXA-232, HLD no-deviation finding].) Both hospitals reported having followed 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.

Both linked their outbreaks to contaminated Olympus duodenoscopes. The committee estimated that at least 250 patients worldwide contracted potentially deadly infections from contaminated duodenoscopes, across all three manufacturers hospitals — and stated that 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.

Enhanced cleaning measures did not resolve the underlying contamination risk. A 2022 meta-analysis of 9,084 post-reprocessing cultures found that even after enhanced cleaning protocols were applied, 5% of scopes remained contaminated, with 0.8% harboring high-risk organisms — a product design failure that even rigorous cleaning protocols could not fully overcome. (Source: Bomman et al., Clinical Endoscopy, January 2022, PMC8831410.) California patients have two years from injury to act.

What Did Olympus Know Before the Cedars-Sinai Outbreak?

By 2015, Olympus had already received direct notification of at least two prior U.S. outbreak events linked to the same scope design. The Virginia Mason Medical Center outbreak in Seattle (November 2012 – August 2013) resulted in 32 confirmed infections with multidrug-resistant E. coli despite no identified breach in the hospital’s reprocessing protocol. (Source: Ross et al., Gastrointest Endosc, 2015, PMID 26092616.) A 2013 NDM-CRE outbreak at an Illinois teaching hospital produced 39 case patients infected with NDM-producing E. coli — an odds ratio of 78 (95% CI, 6.0–1008) for ERCP patients at that facility.

(Source: Epstein et al., JAMA, 2014, PMID 25291580.) Olympus was also aware of European contamination events as early as 2012. It issued no public recall and no warning to U.S. hospitals. The full extent of Olympus’s reporting failure 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 before the U.S. District Court for the District of New Jersey.

The company paid $85 million in penalties and formally admitted failing to file FDA-required adverse-event reports during the period when the Cedars-Sinai, UCLA, Virginia Mason, and the Illinois teaching hospital outbreaks all occurred. (Source: DOJ press release, December 10, 2018; Case No. 2:18-cr-00727-SRC, D.N.J.) In October 2025, Olympus issued an Urgent Field Safety Notice admitting that prior reprocessing protocols for its current-generation TJF-series duodenoscopes 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 Cedars-Sinai before October 2025. The legal argument follows directly. Olympus supplied the scopes used at Cedars-Sinai. Olympus wrote the reprocessing instructions that Cedars-Sinai followed exactly. Olympus had prior direct knowledge of contamination events at multiple U.S. hospitals and failed to report that information to regulators and to the hospitals using its devices — a fact now established as a matter of criminal record.

The liability runs to the manufacturer, not to the hospital that used the equipment as directed.

Why California Patients Must Act Now

California SOL ALERT: 2 Years — Filing Deadline

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

California has a two-year statute of limitations for personal injury claims. The specific start date may vary depending on when you received notice of a possible connection between your health issues and your procedure. Because the timing rules are fact-specific, consult an attorney promptly rather than waiting and potentially forfeiting options. Even if you believe your filing window may have passed, contact us before concluding you have no options — the discovery rule may apply to your situation.

If you received a letter from Cedars-Sinai Medical Center 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 scopes were required to notify patients who had undergone procedures with those devices, regardless of when the procedure occurred. The exposure letter carries real legal significance.

It is the hospital’s own documented acknowledgment that your procedure, the Olympus device, and the contamination risk are connected. In a product liability claim against Olympus, the letter helps establish a direct link between your procedure and the device manufacturer’s admitted safety failure — created in the hospital’s own words, under a federal regulatory obligation. Preserve that letter. The device manufacturer — Olympus Corporation — is the subject of pending litigation.

Cedars-Sinai Medical Center 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, contact us immediately — California’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.

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No fee unless there is a recovery  ·  Available 24/7  ·  California 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 California patient, you have two years to act. Complete these five steps — starting today.

1

Call an attorney before anything else.

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

2

Preserve the hospital exposure letter.

A formal notification from Cedars-Sinai or any California hospital documenting a potential device-related patient safety event is relevant evidence in a product liability claim against Olympus. It 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. 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 if you have difficulty.

4

Do NOT contact Cedars-Sinai’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 — including claims against Olympus that you did not intend to give up. Do not sign anything relating to your scope procedure or resulting infection without speaking to a mass tort attorney first.

Frequently Asked Questions

What was the Cedars-Sinai endoscope outbreak?

In 2015, Cedars-Sinai Medical Center in Los Angeles reported a CRE outbreak linked to Olympus duodenoscopes: 4 patients confirmed infected, approximately 71 patients notified. The outbreak was documented in the LA County Department of Public Health Board of Supervisors memo, March 10, 2015. It occurred simultaneously with the UCLA Ronald Reagan Medical Center outbreak; both hospitals had followed Olympus’s reprocessing instructions without deviation.

Was Cedars-Sinai Medical Center at fault for the outbreak?

However, the device manufacturer, Olympus Corporation, is the subject of pending litigation; Cedars-Sinai is not the defendant. The product liability claims focus on Olympus’s device design, inadequate reprocessing instructions, and its failure to report prior contamination events from hospitals and regulators.

What is CRE and why is it dangerous?

CRE stands for carbapenem-resistant Enterobacteriaceae — bacteria resistant to carbapenem antibiotics, which are typically the treatment of last resort when other options fail. The CDC has documented that CRE bloodstream infections are associated with mortality rates approaching 50 percent. (Source: CDC MMWR, March 5, 2013.) CRE can spread through contaminated medical devices, including inadequately reprocessed duodenoscopes, and there is currently no reliably effective antibiotic treatment for all CRE strains.

I had an ERCP at Cedars-Sinai — what should I do?

Preserve any exposure letter from the hospital and request your complete medical records as soon as possible. Your procedure record should identify the specific Olympus scope model used — key documentation for any potential claim. California has a two-year statute of limitations for personal injury claims, so consulting an attorney promptly is essential. Even if you believe your filing window may have passed, contact an attorney before assuming you have no options.

Can I still file a lawsuit if the Cedars-Sinai outbreak happened in 2015?

Whether you can still file depends on when you were diagnosed, when you received notice of the scope contamination risk, and how California’s discovery rule applies. Do not self-disqualify based on the calendar year alone — the limitations analysis is fact-specific and often more favorable than it appears. Contact an attorney promptly for a case-specific assessment. Even if you believe your deadline has passed, there may still be options worth exploring.

What is Olympus Corporation’s legal responsibility in the Cedars-Sinai outbreak?

Olympus supplied the duodenoscopes used at Cedars-Sinai, authored the reprocessing instructions the hospital followed exactly, and had prior knowledge of contamination outbreaks at multiple U.S. hospitals before 2015. In December 2018, Olympus pleaded guilty to distributing misbranded medical devices and admitted failing to file FDA-required adverse-event reports. (DOJ press release, December 10, 2018.) Pending litigation addresses the device design, cleaning instructions, and Olympus’s prior knowledge and reporting failures.

How do I know if an Olympus scope was used during my Cedars-Sinai procedure?

Request your complete procedure record from Cedars-Sinai — it should identify the specific scope model and serial number used during your ERCP or related procedure. An attorney can assist with the records request if needed. The model and serial number allow your procedure to be linked to specific Olympus devices subject to recalls and field safety notices. Do not delay — medical facilities have retention policies that may affect record availability over time.

California 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 California.

Sources — Click to expand
  1. LA County Department of Public Health, Board of Supervisors Memo, March 10, 2015. (on file)
  2. Humphries RM, Yang S, Kim S, et al. Clin Infect Dis. 2017 Oct 1;65(7):1159-1166. doi: 10.1093/cid/cix527. PMID 29579235.
  3. (on file)
  4. Epstein L, Hunter JC, Arwady MA, et al. JAMA. 2014;312(14):1447-1455. doi: 10.1001/jama.2014.12720. PMID 25291580.
  5. Ross AS, Baliga C, Verma P, Duchin J, Gluck M. Gastrointest Endosc. 2015 Sep;82(3):477-83. PMID 26092616.
  6. U.S. Department of Justice. press release. Olympus Corporation and Executive Plead Guilty. December 10, 2018.
  7. Olympus Corporation. Urgent Field Safety Notice: TJF-Q190V, TJF-Q290V, TJF-Q170V Duodenoscopes. October 14-17, 2025. (on file)
  8. U.S. Food and Drug Administration. Safety Communication: Design of Olympus Duodenoscopes and Potential Risks of Infection. February 19, 2015.
  9. U.S. Food and Drug Administration. Recall No. Z-0905-2025 (MAJ-891 Forceps/Irrigation Plug). December 2024.
  10. Bomman S, Bhatt A, Bhurwal A, et al. Clinical Endoscopy. January 2022. PMC8831410.
  11. 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.
  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 California. If you are located in California, we can discuss your situation and help connect you with qualified representation. Prior results do not guarantee a similar outcome.

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