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 Texas; 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.
70–80%
Olympus U.S. Market Share — Flexible Scopes
$85M
Olympus Guilty Plea Penalty — DOJ 2018
approaching 50%
CRE Mortality Rate Severe Cases
2 Years
TX SOL — Filing Deadline
Texas and the Olympus Scope Litigation
The Olympus scope litigation involves claims by patients who developed antibiotic-resistant infections after ERCP or biliary procedures performed with Olympus duodenoscopes. Texas is home to one of the world’s largest medical complexes and many of the nation’s leading academic medical centers performing ERCP at high volume. The litigation concerns Olympus Corporation’s reprocessing instructions for its endoscopes — not the conduct of treating hospitals or physicians.
Between 2013 and 2016, the CDC documented duodenoscope-associated CRE outbreaks at hospitals in multiple states. Olympus holds approximately 70–80% of the U.S. endoscope market, and the vast majority of Texas hospitals performing ERCP, colonoscopy, and bronchoscopy use Olympus devices. Peer-reviewed literature has documented that standard high-level disinfection protocols were insufficient to eliminate contamination from Olympus TJF-Q180V duodenoscopes at facilities nationwide.
Texas has a 2-year statute of limitations for personal injury claims (Tex. Civ. Prac. & Rem. Code § 16.003), running from the date the cause of action accrues.
Major ERCP Facilities in Texas
Texas’s major academic medical centers and high-volume ERCP referral centers — concentrated in the Houston, Dallas–Fort Worth, San Antonio, and Austin metro areas — perform large numbers of ERCP, colonoscopy, and bronchoscopy procedures each year. Given Olympus’s 70–80% share of the U.S. flexible endoscope market, patients at these facilities were statistically likely to have had procedures performed with Olympus devices. No specific outbreak is being asserted as to any individual Texas facility.
What Is the Olympus Scope Lawsuit?
The Olympus scope lawsuit is a product liability litigation against Olympus Corporation for providing hospitals with inadequate cleaning and reprocessing instructions for its endoscopes. Product liability claims against Olympus in Texas are grounded in design defect (the elevator channel in Olympus duodenoscopes cannot be reliably decontaminated by standard HLD, a fact known to Olympus prior to widespread clinical deployment), failure to warn (Olympus did not timely disclose known CRE transmission risks), and negligence (Olympus had a duty to ensure its devices were safe for clinical use but delayed action on post-market surveillance data).
On December 10, 2018, Olympus Medical Systems Corporation pleaded guilty to three counts of distributing misbranded medical devices and paid $85 million in penalties — admitting it failed to report adverse event information from the FDA. (DOJ press release, December 10, 2018; Case No. 2:18-cr-00727-SRC, D.N.J.) See our Olympus criminal history page for the full record of the guilty plea. The October 2025 Urgent Field Safety Notice updated Olympus’s reprocessing instructions for current-generation TJF duodenoscopes and introduced a Visual Inspection Guide recommending 10X magnification.
Olympus reported 2 deaths and 5 serious injuries from infection potentially related to these devices since 2024, while stating it could not determine whether the devices caused the infections. The December 2024 MAJ-891 Class I Recall affected 30,140 units with 120 reported injuries and 1 reported death following procedures in which the MAJ-891 accessory was used with a cystoscope (not a duodenoscope). (FDA Recall Z-0905-2025.) As of June 2026, no MDL has been filed or is currently pending; cases are proceeding as individual lawsuits in federal and state courts.
Why Texas Patients Are at Risk
Olympus holds approximately 70–80% of the U.S. endoscope market. The vast majority of Texas hospitals performing ERCP, colonoscopy, and bronchoscopy use Olympus devices. Texas’s large population, its high-volume ERCP referral centers, and numerous academic medical centers mean that tens of thousands of Olympus scope procedures are performed in the state each year. Major Texas facilities where ERCP and biliary procedures are routinely performed at high volume include academic medical centers and large regional hospitals across the Houston, Dallas–Fort Worth, San Antonio, and Austin metro areas.
These centers collectively perform a substantial share of the state’s ERCP, colonoscopy, and bronchoscopy volume. Given Olympus’s 70–80% share of the U.S. flexible endoscope market, patients treated at these facilities were statistically likely to have undergone procedures using Olympus devices. No specific outbreak is being asserted as to any individual Texas facility. No specific outbreak data for these institutions is being asserted here — Olympus’s dominant U.S. market share makes these facilities statistically likely users of Olympus devices.
The FDA’s MAUDE adverse event database may contain relevant reports from Texas facilities.
Criteria for This Litigation
The following criteria define eligibility for this litigation:
- ☐ Procedure date on or after January 1, 2015.
- ☐ Procedure performed with an Olympus bronchoscope, upper GI endoscope, or colonoscope.
- ☐ Confirmed infection diagnosis required.
- ☐ Inpatient hospitalization for the infection required. Outpatient treatment with oral antibiotics alone does not qualify.
- ☐ IV antibiotic treatment during hospitalization required.
- ☐ Infection and hospitalization within 30 days of scope procedure. Most patients in this litigation developed symptoms within approximately five days.
- ☐ Claim within Texas’s 2-year statute of limitations from the date of accrual (Tex. Civ. Prac. & Rem. Code § 16.003).
Qualifying Infection Types
- 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)
- other multidrug-resistant or healthcare-associated bloodstream infection confirmed by culture
Note: Wrongful death claims in Texas must be filed within 2 years of the decedent’s death (Tex. Civ. Prac. & Rem. Code § 16.003).
Frequently Asked Questions: Texas Duodenoscope Lawsuit
Can Texas patients file an Olympus duodenoscope lawsuit?
Yes — Texas patients harmed by a contaminated Olympus duodenoscope can file a product liability lawsuit in Texas state or federal court. Texas’s statute of limitations is 2 years from the date the cause of action accrues under Tex. Civ. Prac. & Rem. Code § 16.003.
What is Texas’s statute of limitations for a duodenoscope case?
Texas applies a 2-year statute of limitations for personal injury claims under Tex. Civ. Prac. & Rem. Code § 16.003, running from the date the cause of action accrues. Texas also recognizes a discovery rule in certain cases involving latent injuries or fraudulent failure to report. Note: Wrongful death claims in Texas must be filed within 2 years of the decedent’s death.
What is CRE and why is it so dangerous?
CRE (Carbapenem-Resistant Enterobacteriaceae) are bacteria resistant to carbapenem antibiotics — drugs considered last-resort treatments. When CRE is transmitted via a contaminated duodenoscope, patients often have no warning and few treatment alternatives. Serious CRE infections carry mortality rates approaching 50% in severe cases, and treatment may require prolonged hospitalization and combinations of toxic antibiotics.
What compensation may be available in a Texas duodenoscope case?
Potential damages in a Texas product liability or negligence case may include medical expenses, lost wages and future earning capacity, pain and suffering, emotional distress, and in wrongful death cases, loss of consortium and other economic losses. Texas law may limit certain non-economic damages in medical malpractice cases, but Olympus duodenoscope claims are product liability actions against Olympus — not medical malpractice claims against the hospital. The value of any specific claim depends on individual facts.
Prior results do not guarantee a similar outcome.
How do I know if my ERCP involved an Olympus duodenoscope?
Request your procedure records from the hospital, including device identification logs and operative reports. Major Texas academic centers regularly used Olympus TJF-Q180V duodenoscopes during the period of documented contamination risk (2012–2019).
Is it too late to file if my ERCP was years ago?
It depends on your specific timeline. Texas’s 2-year statute of limitations runs from the date the cause of action accrues. If you were not informed of the contamination risk until years after your procedure, the discovery rule may potentially extend your deadline in limited circumstances. Texas deadlines are strictly enforced, and the discovery rule applies only in limited circumstances.
Sources — Click to expand
- FDA Safety Communication: Infections Associated with Reprocessed Flexible Bronchoscopes (2015). fda.gov.
- FDA Safety Communication: Supplemental Measures to Enhance Duodenoscope Reprocessing (2015). fda.gov.
- CDC. Duodenoscope-Associated Infections. cdc.gov/hai.
- Senate HELP Committee. Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients (2016).
- DOJ press release, December 10, 2018. Case No. 2:18-cr-00727-SRC, D.N.J.
- Olympus Urgent Field Safety Notice, October 14–17, 2025.
- FDA Class I Recall Z-0905-2025 (MAJ-891), December 2024.
- Ross AS, Baliga C, Verma P, Duchin J, Gluck M. A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli. Gastrointest Endosc. 2015;82(3):477–483. PMID 26092616.
- Texas Civil Practice & Remedies Code § 16.003 (2-year personal injury statute of limitations).
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 only in Rhode Island, South Carolina, Connecticut, and Massachusetts, and is not licensed to practice law in Texas. 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 Texas resident. 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
- Overview of the Olympus duodenoscope claims
- Olympus duodenoscope infections in Florida
- Olympus duodenoscope infections in South Carolina
- Virginia Mason ERCP infection cases
- Tennessee — one-year filing deadline
- Wrongful-death claim arising from a scope infection
- Surveillance failures behind the outbreaks
- What the October 2025 notice admitted
- Warning letters and Olympus compliance
- The 2018 DOJ guilty plea
- What to do after an exposure letter
- Why duodenoscopes are hard to clean
- Did you get an infection after a colonoscopy?
- CRE claims against Olympus
- Did you get sick after an ERCP?
- Hartford Hospital scope infection claims
- Everything about the Olympus scope litigation
Where we practice
Marin & Murphy Law Firm attorneys are licensed in Rhode Island, Connecticut, Massachusetts, and South Carolina. We are not licensed in Texas. The firm does not accept Texas legal matters; inquiries from Texas residents are referred to attorneys licensed in Texas. 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.