Olympus Duodenoscope Lawsuit in Florida

Super Lawyers® 2014–2024(888) 348-2735

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 Florida; 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.

Florida 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. Florida is home to some of the nation’s largest academic medical centers and high-volume ERCP referral destinations. 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 Florida 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.

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 Florida 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 Florida Patients Are at Risk

Olympus holds approximately 70–80% of the U.S. endoscope market. The vast majority of Florida hospitals performing ERCP, colonoscopy, and bronchoscopy use Olympus devices. Florida’s large population and numerous academic medical centers mean that thousands of Olympus scope procedures are performed in the state each year. Major Florida facilities where ERCP and biliary procedures are routinely performed at high volume include academic medical centers, national referral destinations, and large regional hospitals across the Gainesville, Jacksonville, Tampa, and Miami 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 Florida 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 Florida 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.

Frequently Asked Questions: Florida Duodenoscope Lawsuit

Can Florida patients file an Olympus duodenoscope lawsuit?

Yes — Florida patients harmed by a contaminated Olympus duodenoscope can file a product liability lawsuit in Florida state or federal court. Filing deadlines vary depending on the type of claim and when the injury occurred; a Florida-licensed attorney can advise on the deadline that applies to a specific situation.

How much time do I have to bring a Florida duodenoscope claim?

Filing deadlines in Florida depend on the legal theory of the claim, the type of injury, and when the injury occurred, and Florida law in this area has changed in recent years. Because the applicable deadline can vary and is strictly enforced, a person who believes they may have a claim should consult a Florida-licensed attorney promptly to determine the deadline that applies to their specific situation.

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 Florida duodenoscope case?

Potential damages in a Florida 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. 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 Florida academic centers regularly use 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 and when your injury occurred. If you were not informed of the contamination risk until well after your procedure, a discovery-rule argument may apply in limited circumstances. Florida filing deadlines are strictly enforced, so a person who believes they may have a claim should consult a Florida-licensed attorney promptly to determine whether their claim is still timely.

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.