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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.

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

PA SOL — Filing Deadline

Pennsylvania and the Olympus Scope Litigation

The Olympus scope litigation involves claims by patients who developed infections after ERCP or biliary procedures performed with Olympus duodenoscopes. The litigation concerns Olympus Corporation’s reprocessing instructions for its endoscopes — not the conduct of treating hospitals or physicians. Olympus holds approximately 70–80% of the U.S. endoscope market, and Pennsylvania is home to major academic medical centers where ERCP and other endoscopic procedures are performed at high volume using Olympus devices.

Pennsylvania patients who developed a serious infection after a scope procedure may have legal rights in the national Olympus scope product liability litigation, regardless of which Pennsylvania facility performed the procedure. Pennsylvania has a 2-year statute of limitations for personal injury claims (42 Pa.C.S. § 5524), running from the date the injury was discovered or reasonably should have been discovered.

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 are grounded in design defect (the elevator channel mechanism cannot be adequately cleaned with standard HLD protocols), failure to warn (Olympus did not disclose the known risk of patient-to-patient transmission in a timely manner), and negligence (Olympus received post-market surveillance data indicating contamination risks yet delayed action).

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 from the available reports 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 Pennsylvania Patients Are at Risk

Olympus holds approximately 70–80% of the U.S. endoscope market. The vast majority of Pennsylvania hospitals performing ERCP, colonoscopy, and bronchoscopy use Olympus devices, so Pennsylvania patients who had scope procedures at major facilities in the state likely had them performed with Olympus equipment. Major Pennsylvania facilities where scope procedures are routinely performed include academic medical centers and regional hospitals across Philadelphia, central Pennsylvania, and other 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 Pennsylvania 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.

Criteria for This Litigation

The following criteria define eligibility for this litigation:

  • ☐  Underwent ERCP, biliary stenting, sphincterotomy, or related procedure at a Pennsylvania facility on or after January 1, 2015.
  • ☐  Procedure performed with an Olympus duodenoscope (TJF-Q180V, TJF-Q190V, or similar model).
  • ☐  Subsequently diagnosed with CRE, carbapenem-resistant Klebsiella, carbapenem-resistant E. coli, or other antibiotic-resistant infection.
  • ☐  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.
  • ☐  Within 2 years of the date of discovery of the injury (Pennsylvania SOL; discovery rule may apply).

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 Pennsylvania must be brought within 2 years of the patient’s death and must be filed by the personal representative of the estate or qualifying family members. Survival actions may also be available.

Frequently Asked Questions: Pennsylvania Duodenoscope Lawsuit

Can Pennsylvania patients file an Olympus scope lawsuit?

Yes — Pennsylvania patients harmed by a contaminated Olympus duodenoscope can file a product liability lawsuit in Pennsylvania state or federal court. The statute of limitations is 2 years from discovery of injury. Pennsylvania patients who developed drug-resistant infections after scope procedures at any Pennsylvania facility may wish to consult an attorney about their options.

What is the statute of limitations for a duodenoscope lawsuit in Pennsylvania?

Pennsylvania’s statute of limitations for personal injury is 2 years (42 Pa.C.S. § 5524), running from the date you discovered — or reasonably should have discovered — the injury and its connection to the duodenoscope procedure. Under Pennsylvania’s discovery rule, many patients were not aware of the contamination risk until years after their procedures — the clock may not have started when you think it did. Under Pennsylvania’s discovery rule, the limitations period may not begin until the connection between the infection and the procedure is discovered or reasonably should have been discovered.

What is CRE and how serious is a CRE infection?

CRE (Carbapenem-Resistant Enterobacteriaceae) are bacteria resistant to most antibiotics, including last-resort carbapenems. Serious CRE infections carry mortality rates approaching 50% in severe cases. Treatment options are extremely limited, often requiring prolonged hospitalization, toxic antibiotic combinations with significant side effects, and carrying a significant risk of treatment failure.

What compensation may be available in a Pennsylvania duodenoscope case?

Potential damages in a Pennsylvania duodenoscope lawsuit may include medical expenses (past and future), lost wages and earning capacity, pain and suffering, emotional distress, and in wrongful death cases, loss of companionship and financial support. Punitive damages may be available where the manufacturer’s conduct was particularly egregious. The value of any claim depends on individual facts. Prior results do not guarantee a similar outcome.

How do I know if my ERCP used an Olympus duodenoscope?

Request the device identification records from your procedure — operative reports should identify the specific scope model and serial number used. Olympus duodenoscopes, including the TJF-Q180V, were widely used at major Pennsylvania ERCP centers.

Is it too late to file if my ERCP was years ago?

Not necessarily. Pennsylvania’s discovery rule means the 2-year period runs from when you knew — or reasonably should have known — about the connection between your infection and the duodenoscope. Many patients were not informed of the contamination risk until years after their procedures.

Sources — Click to expand
  1. FDA Safety Communication: Infections Associated with Reprocessed Flexible Bronchoscopes (2015). fda.gov.
  2. FDA Safety Communication: Supplemental Measures to Enhance Duodenoscope Reprocessing (2015). fda.gov.
  3. CDC. Duodenoscope-Associated Infections. cdc.gov/hai.
  4. Senate HELP Committee. Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients (2016).
  5. DOJ press release, December 10, 2018. Case No. 2:18-cr-00727-SRC, D.N.J.
  6. Olympus Urgent Field Safety Notice, October 14–17, 2025.
  7. FDA Class I Recall Z-0905-2025 (MAJ-891), December 2024.
  8. 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.
  9. Pennsylvania Civil Statute of Limitations: 42 Pa.C.S. § 5524 (personal injury — 2 years).

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 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.

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.

Where we practice

Marin & Murphy Law Firm attorneys are licensed in Rhode Island, Connecticut, Massachusetts, and South Carolina. We are not licensed in Pennsylvania. The firm does not accept Pennsylvania legal matters; inquiries from Pennsylvania residents are referred to attorneys licensed in Pennsylvania. 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.