Infection After ERCP Lawsuit — Legal Rights After a Contaminated Duodenoscope

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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.

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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.

Your Legal Rights Against Olympus

ERCP (Endoscopic Retrograde Cholangiopancreatography) is performed with Olympus duodenoscopes. Patients who developed a confirmed infection within 30 days of an ERCP procedure — requiring inpatient hospitalization and IV antibiotic treatment on or after January 1, 2015 — may have a product liability claim against Olympus Corporation, the device manufacturer. The hospital is not the defendant.

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.

Why Does ERCP Carry a Higher Infection Risk Than Other Scope Procedures?

ERCP is a procedure used to diagnose and treat conditions of the bile duct, gallbladder, and pancreas, including pancreatic cancer and bile duct obstructions. Approximately 500,000 to 650,000 ERCPs are performed annually in the United States (Source: FDA Safety Communication, February 2015), and Olympus makes approximately 85% of the duodenoscopes used to perform them. ERCP is considered the procedure type at the center of the Olympus scope infection litigation because the duodenoscope used in ERCP contains a unique design feature that creates an exceptional contamination risk.

At the tip of every Olympus duodenoscope sits a small hinged piece called the elevator mechanism. This mechanism raises and lowers instruments passed through the scope during ERCP procedures. The elevator mechanism contains microscopic crevices and joints that standard cleaning brushes cannot reach. Biological material from previous patients — including drug-resistant bacteria — lodges in these crevices during procedures and remains there even after manufacturer-recommended high-level disinfection.

The FDA’s February 19, 2015 Safety Communication specifically addressed this design flaw in ERCP duodenoscopes, citing 75 medical device reports involving approximately 135 patients between January 2013 and December 2014 — before any public warning had been issued (Source: FDA Safety Communication, February 19, 2015). A 2022 meta-analysis of 9,084 post-reprocessing cultures found 5% contamination even after enhanced cleaning protocols (Source: Bomman et al., Clinical Endoscopy, January 2022, PMC8831410).

Even when hospitals follow Olympus’s instructions exactly, the elevator mechanism’s design makes complete decontamination effectively impossible without a fundamental redesign.

What Outbreaks Have Been Linked to ERCP Procedures?

Virginia Mason Medical Center (Seattle, WA)

Between November 2012 and August 2013, Virginia Mason conducted 1,149 ERCP procedures using Olympus duodenoscopes. Thirty-two patients developed MDR (multidrug-resistant) E. coli infections. Seven patients died within 31 days of a positive culture; 16 patients had died by March 2015; and 18 total outbreak-associated deaths were documented. MDR E. coli was recovered from 4 of 8 Olympus duodenoscopes tested. The peer-reviewed paper concluded: “The existing manufacturer-recommended high-level disinfection protocols for duodenoscopes are inadequate.” Critically, “No breach in high-level disinfection protocol or infection control practices was identified.” (Source: Ross et al., Gastrointestinal Endoscopy, September 2015, Vol. 82(3):477–83, PMID 26092616.)

UCLA Ronald Reagan Medical Center (Los Angeles, CA)

UCLA’s ERCP-linked outbreak involved 17 patients: 9 confirmed active infections, 7 asymptomatic carriers, and 1 index patient. Two patients died. Approximately 179 patients were potentially exposed. The pathogen was OXA-232 carbapenem-resistant Klebsiella pneumoniae. The investigation found no deviations from FDA or manufacturer recommendations in the hospital’s reprocessing procedures (Source: Humphries et al., Clinical Infectious Diseases, 2017, PMID 29579235).

Both hospitals followed Olympus reprocessing instructions without deviation.

What Did Olympus Know About ERCP Contamination Risk?

Olympus’s knowledge of the ERCP duodenoscope contamination problem is documented across decades of regulatory history. By 2012, Olympus had been alerted to contamination problems with its duodenoscopes — including a CRE outbreak linked to its scopes at a hospital in the Netherlands — but, as the U.S. Senate HELP Committee later documented, did not alert U.S. hospitals or regulators. Olympus did not submit to the FDA the adverse-event reports that federal rules required. In December 2018, Olympus Medical Systems Corporation pleaded guilty to three counts — and former senior executive Hisao Yabe to one count — of distributing misbranded medical devices.

The company paid $85 million in criminal penalties and admitted to failing to file the adverse-event reports that FDA rules required (Source: DOJ Press Release, December 10, 2018; Case No. 2:18-cr-00727-SRC, U.S. District Court, D.N.J.). The conviction was based on Olympus’s failure to file the FDA-required adverse-event reports about infections associated with its duodenoscopes. In October 2025, Olympus issued an Urgent Field Safety Notice updating its reprocessing instructions for its current-generation TJF-series ERCP duodenoscopes — the TJF-Q190V, TJF-Q290V, and TJF-Q170V — and recommending that hospitals use 10X magnification tools to properly inspect the scopes — tools they had never previously been told were necessary.

The notice confirmed 2 deaths and 5 serious injuries linked to current-generation TJF scopes (Source: Olympus Urgent Field Safety Notice, October 2025). The legal argument in this litigation is that Olympus — not the hospital — was responsible for providing safe cleaning instructions. Hospitals reported following the 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.

What Qualifying Injuries May Support a Legal Claim After ERCP?

To evaluate whether you may have a legal claim following an ERCP procedure, the confirmed intake criteria are:

• The procedure must have occurred on or after January 1, 2015.
• ERCP is performed using Olympus duodenoscopes — the confirmed primary device class in this litigation.
• A confirmed infection diagnosis is required.
• Inpatient hospitalization for the infection is required. Outpatient treatment with oral antibiotics alone does not qualify.
• IV antibiotic treatment during hospitalization is required.
• The infection and resulting hospitalization must have occurred within 30 days of your ERCP procedure. Most patients in this litigation developed sepsis symptoms within approximately five days.
• You must not have been undergoing dialysis or chemotherapy at the time of your hospitalization.
• If you received a notice of exposure from your hospital after a scope procedure, you may qualify even without a confirmed infection diagnosis — contact us.

If the scope or any component broke apart during your procedure and required emergency surgery to remove fragments, this may represent a separate product liability claim — contact us to discuss your situation. Even if you believe your filing deadline may have passed, contact us before assuming you have no options.

What Should I Do If I Developed an Infection After ERCP?

If you developed an infection following an ERCP procedure, the following steps can protect your legal rights:

1. Request your procedure records. Ask for the endoscopy report identifying the specific Olympus scope model used during your ERCP. Key model numbers to look for on your procedure record include TJF-Q180V, TJF-Q190V, and TJF-Q290V. Record the facility name, the date of the procedure, and the performing physician.
2. Preserve infection records. Obtain all records from your hospitalization: blood culture results, the organism identified, antibiotic treatment records, and discharge records. The specific organism name and its antibiotic resistance profile are the primary evidence connecting your infection to a contaminated scope.
3. Note the timing. The 30-day window from your ERCP date to your infection diagnosis is the critical threshold. Record exact dates.
4. Do not contact the hospital about a legal claim without consulting an attorney first. Statements made to the hospital could affect your case.
5. Contact Marin & Murphy. Our attorneys evaluate Olympus scope infection claims nationwide. The consultation is free and creates no obligation.

Marin & Murphy Law Firm is investigating Olympus scope infection claims for patients nationwide. Contact us at (888) 348-2735. The consultation is free and creates no obligation.