Olympus Duodenoscope Infection Lawsuits
Page Updated June 2026 — reflecting the FDA’s July 2025 duodenoscope safety update and Florida filing windows that may be affected by the state’s 12-year product statute of repose.
Hospitals rely on advanced medical devices to diagnose and treat serious conditions. Patients trust that the equipment used during these procedures is safe, sterile, and properly designed. Unfortunately, evidence accumulated over the last decade has shown that certain Olympus duodenoscopes may have exposed patients to dangerous infections because of design features that allegedly made complete sterilization difficult or impossible.
Rafferty Domnick Cunningham & Yaffa is actively investigating claims involving Olympus duodenoscopes and other reusable scopes that allegedly transmitted harmful bacteria from patient to patient, causing severe infections, sepsis, prolonged hospitalization, permanent injury, and, in some cases, death.
If you or a loved one developed a serious infection after an ERCP or other scope procedure, you may have legal options.
Unlike many medical device lawsuits, Olympus duodenoscope litigation is not based on a device that broke or malfunctioned. The allegations are more troubling. Patients claim the scopes were functioning exactly as designed, but that the design itself made complete sterilization impossible, allowing dangerous bacteria to pass from one patient to another even when hospitals followed cleaning instructions.
What Is a Duodenoscope and What Is an ERCP Procedure?
A duodenoscope is a specialized flexible endoscope used during a procedure known as Endoscopic Retrograde Cholangiopancreatography, commonly called ERCP.
ERCP allows physicians to diagnose and treat conditions affecting the bile ducts, pancreas, gallbladder, and liver. During the procedure, the physician inserts the scope through the patient’s mouth, guides it through the stomach, and advances it into the duodenum, the first section of the small intestine.
The device’s camera and specialized instruments allow doctors to:
- Remove gallstones
- Treat bile duct blockages
- Place stents
- Investigate pancreatic conditions
- Diagnose digestive-system disorders
Unlike many medical instruments, duodenoscopes contain moving mechanical parts, including a tiny elevator mechanism used to guide instruments through the device.
Because the scopes are expensive and highly specialized, hospitals reuse them after cleaning and disinfection.
The central issue in Olympus litigation is whether certain scope designs could retain bacteria even after hospitals followed the manufacturer’s cleaning instructions.
The Problem With Olympus Scope Design
Investigators, regulators, hospitals, and plaintiffs have focused on one central allegation: certain Olympus duodenoscopes contained design features that made complete sterilization extraordinarily difficult.
The devices contain small crevices, moving components, channels, and mechanical parts that can be difficult to access during cleaning.
According to lawsuits and regulatory findings, biological material and bacteria could remain trapped inside these areas despite standard reprocessing procedures.
When the scope was used on another patient, those bacteria could potentially be transferred directly into the body.
The concern became particularly serious because many of the reported infections involved antibiotic-resistant organisms that are notoriously difficult to treat.
Perhaps most troubling, multiple outbreaks allegedly occurred even when hospitals followed the manufacturer’s cleaning instructions.
Infections Linked to Contaminated Duodenoscopes
Between 2012 and 2016, contaminated duodenoscopes were linked to outbreaks of drug-resistant infections at hospitals across the United States, most notably Ronald Reagan UCLA Medical Center and Virginia Mason Medical Center in Seattle.
A 2016 Senate HELP Committee investigation identified at least 250 infected patients across 25 documented outbreaks worldwide. Investigators concluded that infection transmission occurred even at hospitals that followed the manufacturer’s cleaning instructions.
Patients allegedly exposed to contaminated scopes have developed:
- Carbapenem-resistant Enterobacteriaceae (CRE)
- Other antibiotic-resistant infections
- Bloodstream infections
- Sepsis
- Gastrointestinal infections
- Tuberculosis
- Other hospital-acquired infections requiring extensive treatment
For vulnerable patients, these infections can become life-threatening within days.
Many patients do not initially realize a scope procedure may have caused the infection because symptoms often appear days or weeks after treatment.
While sepsis resulting from a contaminated medical device differs from sepsis caused by negligent medical or nursing-home care, both can lead to catastrophic injuries and require immediate treatment. RDCY represents individuals and families in both types of cases.
Olympus Scope Models Associated With Infection Concerns
Several Olympus devices have been linked to infection investigations, recalls, regulatory actions, or litigation, including:
Regulators and investigators have examined whether aspects of these designs allowed bacteria to remain inside the device despite cleaning and disinfection.
The FDA has repeatedly encouraged hospitals to move away from older fixed-endcap designs in favor of devices that incorporate disposable components.
Symptoms to Watch For After a Scope Procedure
Patients who develop infections after an ERCP or similar scope procedure may experience symptoms within days or weeks.
Warning signs may include:
- Fever
- Chills
- Severe abdominal pain
- Nausea
- Vomiting
- Fatigue
- Weakness
- Bloodstream infections
- Rapid heart rate
- Confusion
- Low blood pressure
- Other symptoms associated with sepsis
Anyone experiencing these symptoms after a scope procedure should seek immediate medical attention.
Who May Qualify for an Olympus Scope Lawsuit?
You may qualify for a claim if:
- You underwent an ERCP, endoscopy, bronchoscopy, or similar scope procedure
- The procedure occurred between approximately 2012 and the present
- You later developed a serious infection, including CRE, another antibiotic-resistant infection, sepsis, or a related complication
- The infection required hospitalization, additional treatment, surgery, or prolonged medical care
- The infection caused lasting harm or permanent injury
- A loved one died following a serious post-procedure infection
You do not need to know which scope was used during your procedure. Identifying the device involved is part of the investigation process.
How Long Do Florida Patients Have to File a Scope Infection Claim?
Florida law places multiple deadlines on these cases, and both can be important.
The first involves statutes of limitation, which generally govern how long a person has to file a lawsuit after discovering an injury.
The second may be even more significant. Florida’s product-liability statute of repose generally bars claims more than twelve years after a product was first delivered, regardless of when the injury is discovered.
Many Olympus scopes entered hospitals between 2010 and 2015. As a result, some potential filing windows may already have closed or may be approaching expiration. There are exceptions — including where a manufacturer concealed a known defect — which is one more reason to have your timeline reviewed rather than assume it is too late.
There is another important distinction.
Claims against the manufacturer are generally product-liability cases. Claims involving a hospital’s cleaning procedures, infection-control measures, or treatment decisions may involve medical-malpractice law, which carries separate procedural requirements, including pre-suit investigation obligations under Florida law.
Determining which deadlines apply requires a detailed review of the facts and should never be estimated from a website.
Olympus Recall and FDA Safety Concerns
Federal regulators have spent years studying the infection risks associated with reusable duodenoscopes.
Beginning in 2015, the FDA issued safety communications regarding infection transmission associated with certain reusable scope designs.
Olympus later redesigned certain devices and implemented corrective actions, but concerns persisted.
In August 2019, the FDA urged healthcare providers to transition away from fixed-endcap duodenoscopes and toward models with disposable components whenever possible.
The agency reinforced that position in April 2022.
The FDA’s guidance on duodenoscope-related infection risks remained active as of its July 2025 update, reflecting the agency’s continuing concern regarding infection transmission from reusable scopes.
What Courts and Prosecutors Have Already Found
The allegations surrounding Olympus duodenoscopes have not been limited to lawsuits. They have also been examined by juries, federal prosecutors, regulators, and congressional investigators.
In 2017, the family of Richard Bigler brought one of the first duodenoscope infection cases to reach trial. Bigler died after developing a CRE infection linked to a contaminated Olympus scope used at Virginia Mason Medical Center.
Following an eight-week trial, a Seattle jury ordered Olympus to pay approximately $6.6 million and the hospital to pay an additional $1 million.
A separate scope-infection lawsuit later settled confidentially before trial.
In December 2018, Olympus Medical Systems Corporation pleaded guilty in federal court in New Jersey to failing to file required reports involving scope-related infections while continuing to market and sell the devices.
The company agreed to pay an $85 million criminal penalty consisting of an $80 million fine and $5 million forfeiture.
Federal investigators and congressional reports concluded that Olympus had information regarding infection-transmission risks years before hospitals and regulators were fully informed.
What Happens When You Contact Us About a Scope Infection?
Most people have no idea where to begin after learning that a medical device may have caused a serious infection.
The process generally starts with a conversation.
First, we discuss when the procedure occurred, where it took place, when symptoms appeared, and what diagnosis was ultimately made.
Second, we obtain and review relevant medical records.
Third, we investigate the device itself.
Many hospitals maintain records identifying the specific scope used during a procedure, including:
- Device model numbers
- Serial numbers
- Cleaning records
- Reprocessing documentation
- Maintenance logs
Finally, we evaluate whether the facts support claims against the manufacturer, a healthcare provider, or both.
We also assess filing deadlines and other legal requirements that may affect the case.
There is no fee to have your situation reviewed, and no attorney’s fee unless compensation is recovered.
For Referring Attorneys
Rafferty Domnick Cunningham & Yaffa accepts duodenoscope infection referrals, contaminated-medical-device referrals, and co-counsel opportunities from attorneys nationwide.
These cases often require extensive investigation involving device identification, hospital reprocessing records, infection timelines, and Florida-specific filing issues.
Our team welcomes opportunities to collaborate with referring counsel when appropriate.
Frequently Asked Questions About Olympus Scope Infections
Can I sue for an infection after an ERCP or endoscopy?
Possibly. If you developed a serious infection, particularly an antibiotic-resistant infection or sepsis, after an ERCP or similar procedure, you may have a claim against the device manufacturer, the healthcare provider, or both.
Did Olympus know its scopes could spread infections?
Federal investigations, congressional findings, and the company’s 2018 criminal resolution all focused on what Olympus knew regarding infection-transmission risks and when those risks were disclosed to hospitals and regulators.
Is there a class action or MDL for Olympus scope infections?
These claims have generally proceeded as individual lawsuits rather than through a nationwide class action or multidistrict litigation. Individual facts and medical records remain critically important.
Which Olympus scopes have been linked to infection concerns?
Regulatory actions and litigation have involved multiple models, including the TJF-Q180V, TJF-Q190V, TJF-160VF, JF-140F, and related components such as the MAJ-891 channel plug.
How long do I have to file a duodenoscope infection lawsuit in Florida?
That depends on the facts of your case, the type of claim involved, and when relevant deadlines began to run. Product-liability statutes of limitation and Florida’s twelve-year statute of repose can both affect filing deadlines.
What compensation may be available?
Depending on the circumstances, compensation may include medical expenses, lost income, future medical costs, pain and suffering, and wrongful-death damages for surviving family members.
Speak With an Attorney About an Olympus Scope Infection
If you or someone you love developed a serious infection after an ERCP or other scope procedure, you may have legal options.
The attorneys at Rafferty Domnick Cunningham & Yaffa are actively investigating Olympus duodenoscope infection claims and other contaminated-medical-device cases.
A free consultation can help determine:
- Whether an Olympus scope was involved
- Whether the infection may be linked to device contamination
- Which legal options may be available
- Whether important filing deadlines may apply
Contact RDCY today for a free and confidential case evaluation.
