Olympus Scope Lawsuit

Between 2013 and 2024, contaminated Olympus duodenoscopes infected hundreds of patients at hospitals across the United States. At least 35 people died.

What happened?  These awful infections were caused by dangerous, drug-resistant bacteria that were extremely difficult to treat.

So you had patients who went to the hospital, often getting diagnostic or therapeutic procedures that they did not think would be a big deal, only to come out with infections that damaged organs, required months of intensive care, or, tragically, proved fatal.

This page explains the disaster of how this all went down, and our lawyers explain the legal options available to patients and families harmed by contaminated Olympus scopes.

If you have a potential claim, call our Olympus scope lawyers at 800-553-8082 or contact us online for a free consultation.

What Is a Duodenoscope?

A duodenoscope is a flexible, lighted tube that physicians thread down a patient’s throat, through the stomach, and into the duodenum, the first section of the small intestine. From there, the scope allows access to the bile ducts, pancreatic duct, and surrounding anatomy. The procedure that uses it is called ERCP, which stands for endoscopic retrograde cholangiopancreatography.

ERCP is one of the most technically demanding procedures in gastroenterology. Our law firm has handled more than our share of medical malpractice lawsuits involving ERCP procedures. The procedure is used to diagnose and treat conditions involving the bile ducts and pancreas, including gallstones lodged in the common bile duct, strictures, tumors, and chronic pancreatitis.

One reason ERCP can be a strong medical malpractice case is that it should not go wrong.  This is not major surgery. It is usually an outpatient procedure that is performed hundreds of thousands of times in this country.

This is why it was a big deal for Olympus to dominate the market for the scopes used in this procedure — it was very profitable.  The scopes can cost around $18,000.

The Design Defect: Why These Scopes Cannot Be Reliably Cleaned

The duodenoscope differs from a standard endoscope because of its small mechanical component at its tip called the elevator mechanism. This elevator mechanism is at the root of these lawsuits.

How it works is that the elevator channel sits at the tip of the duodenoscope. This is the end that contacts the patient’s internal tissue, bile, pancreatic fluid, and blood. So there is no question the channel will be contaminated after use. If you were the first one to use the scope, no problem.  The issue is whether the next patient who used that scope was safe or was it contaminated from prior patients.  Because you cannot use an $18,000 scope just once. The hospital has to clean it and use it on the next patient.

How do you do that? You use brushes, detergents, and chemical disinfectants to reach every contaminated surface of the device. But the problem is that the elevator channel is not a smooth, open cavity. It contains tiny gaps between the elevator lever and its housing. It has seals, joints, and moving parts that can trap fluid and debris. So the channel’s geometry makes it impossible to be sure you have everything clean for the next patient. And if you do not, that is when you run the risk of bacteria and infection.

Bacteria that survive the cleaning process are tough nuts to crack. They do not just sit on the surface waiting to be wiped away or die out on their own.  One of the dangerous things they do in these scopes is form biofilms. These are structured colonies of microorganisms that adhere to surfaces and secrete a protective matrix that makes them even tougher to kill and harder to get rid of.  So the usual chemical disinfection does not fare well against these biofilms.  The next patient who undergoes ERCP with that scope runs a real risk of being exposed to organisms from previous patients.

You now know the basis of the product liability lawsuits against Olympus. We allege that the device was engineered in a way that made reliable reprocessing impossible.

Safer Alternative Designs Were Available

So when we argue design defect, we must show there was a better way.  Olympus was not trapped by a single engineering design.  In fact, by the time many later procedures were performed, fully disposable duodenoscopes were already on the market.

In 2019, the FDA cleared Boston Scientific’s EXALT Model D, the first fully disposable, single-use duodenoscope. Boston Scientific began a limited U.S. market release in early 2020. Unlike a conventional Olympus duodenoscope, the EXALT was intended to be discarded after one ERCP, eliminating the need to clean and disinfect the scope for another patient.

This blows away Olympus’ argument that infection risk is an unfortunate byproduct of a necessary reusable device. But Olympus knew it needed to compete with disposable duodenscopes, so it came up with that TJF-Q190V. Olympus promoted this as an improved design by adding a removable distal endcap. But this was at best a partial fix. The new device still had the same basic side-viewing configuration, elevator mechanism, and internal channels that made complete sterilization impossible.  A removable piece at the tip helps but does not eliminate the problem.

What Did Olympus Know, and When Did It Know It?

Beyond the design defect, the big question is: did Olympus know of the problem and do nothing to warn hospitals that the infection risk with these medical devices was unacceptable?  There is still a lot of pretrial discovery needed in these case to know the whole picture but the evidence we already know is a problem for Olympus.

Internal documents, FDA communications, and preliminary litigation discovery have revealed that Olympus was aware of contamination risks associated with its duodenoscopes long before the major outbreaks became public.

So it is safe to say that Olympus knew about contamination risks for more than a decade. The company made incremental changes, but they were a butter knife in a gunfight. More needed to be done and the older devices needed to be recalled.

The Problem Did Not End With the Q180V

For years, Olympus has framed the duodenoscope crisis as a problem tied to older devices, particularly the TJF-Q180V model linked to early CRE outbreaks. The company’s response was to introduce newer designs, including the TJF-Q190V, which included a removable distal endcap intended to improve cleaning.

That narrative is now being challenged by Olympus scope lawsuits around the country.

Plaintiffs allege the Q190V did not solve the core problem. The device still relied on the same basic design features that made earlier duodenoscopes difficult to clean, including the side viewing configuration, the elevator mechanism, and internal channels that can trap biological material. The removable endcap was presented as a solution. Plaintiffs argue that, at best, it was a partial fix.

Regulatory history supports that skepticism. Olympus issued corrective actions involving the Q190V and its distal cover, and in July 2023 the company initiated a Class II recall of the TJF-Q190V after reports of patient infections and positive cultures. FDA records also show additional Q190V-related corrective actions and recalls in 2025 and 2026.

That is the key point. This is not just a story about what happened in Seattle in 2013 or Los Angeles in 2015. Plaintiffs now allege that contamination risks persisted into the next generation of Olympus scopes, even after the company had years of data, warnings, and real world outbreaks.

If plaintiffs prove that, it undercuts one of Olympus’s central defenses: that the problem was identified, addressed, and fixed. The newer cases tell a different story.

The FDA’s Role: Regulatory Failure

Olympus bears primary responsibility for the harm caused by its defective devices. But the FDA’s performance was uninspiring to say the least.

The agency knew about the risks of duodenoscope contamination as early as 2013. Between 2013 and 2015, the FDA received hundreds of adverse event reports involving duodenoscope-related infections. The agency did not act aggressively. It did not order a broad recall. It did not require immediate design changes. It issued safety communications that shifted much of the burden onto hospitals while continuing to allow the devices to be sold.

Part of the problem is structural. Duodenoscopes entered the market through the FDA’s 510(k) clearance pathway, which allows medical devices to be sold without clinical trials if they are substantially equivalent to devices already on the market. The 510(k) process is faster and cheaper than premarket approval, but it does not require the kind of independent clinical proof many patients assume exists.

When safety problems emerged, the FDA had tools available. It could issue warning letters. It could press the company. It could refer cases to the Department of Justice for potential criminal prosecution. What it did not do quickly and decisively was remove the devices from the market or require an immediate engineering solution.

The result was years of preventable infections while the FDA and Olympus engaged in a slow regulatory process.

One of the more troubling features of the Olympus story is that the company’s regulatory problems did not end after the early duodenoscope scandals became public. Even after years of outbreak reports, lawsuits, FDA communications, and public scrutiny, Olympus continued to face safety and quality control problems with other endoscopic devices and related components.

That cuts against the argument that Olympus learned its lesson and cleaned up its act. Plaintiffs can argue that Olympus did not merely mishandle one product line years ago. They can argue that the company continued to show the same core problems with device safety, reprocessing, post-market surveillance, and regulatory compliance long after the duodenoscope crisis should have forced reform.

A jury may view repeated recalls, warning letters, import alerts, and manufacturing problems not as isolated events, but as evidence of a company that kept reacting late, warning late, and fixing problems only after patients had already been harmed.

Why Infection Timing and Culture Results Is a Big Deal

The strongest Olympus duodenoscope cases usually have a clear medical timeline. A patient undergoes ERCP or another scope procedure, develops fever, sepsis, bacteremia, abscess, cholangitis, or another serious infection within days or weeks, and hospital cultures identify a drug-resistant organism such as CRE, VRE, Pseudomonas, Klebsiella, or another pathogen associated with health care transmission.

That timing matters because Olympus will almost always dispute causation. The defense may argue that the infection came from the patient’s underlying illness, the hospital environment, another procedure, another device, or an unrelated source. Plaintiffs need records that connect the procedure, the scope, the organism, and the infection timeline.

Important evidence includes the ERCP report, scope tracking logs, culture and sensitivity results, infectious disease notes, antibiotic records, ICU records, hospital infection control records, sepsis records, blood cultures, biliary cultures, device reprocessing records, and any notice from the hospital that other patients may have been exposed to the same contaminated device.

Current Status of Olympus Duodenoscope Litigation

Olympus duodenoscope cases are being filed in both federal and state courts across the United States. There is currently no formal multidistrict litigation consolidating all federal cases and no class action lawsuit that controls every victim’s claim. For many victims, that may be a good thing because serious injury and wrongful death cases often need individualized proof of infection timing, culture results, causation, and damages.

The litigation gained renewed momentum in 2025 following FDA import alerts involving Olympus products and the company’s later field safety actions addressing contamination concerns with newer duodenoscope models. These regulatory actions support what plaintiffs have argued for years: Olympus did not fully eliminate the design problem that allows bacteria to survive between patients.

The regulatory activity has continued. FDA records show a 2025 corrective action involving all TJF-Q190V serial numbers after post-market data raised concerns about microbial contamination when reprocessing was delayed. Another recall initiated in October 2025 cited continued reports of positive cultures and infections involving the TJF-Q190V. In 2026, Olympus also initiated a Class II recall involving the single-use distal cover used with the Q190V.

Cases filed in 2024 and 2025 are particularly significant because they involve newer generation scopes that Olympus marketed as safer alternatives to the original TJF-Q180V. If plaintiffs can prove that even the updated designs remained defective, it undermines Olympus’s primary defense that the company identified and corrected the problem years ago.

Discovery in active cases will focus on internal company documents, communications between Olympus and the FDA, hospital infection reports, scope tracking records, engineering assessments of the elevator channel, and the decision making behind later design changes. Those documents will play a central role in upcoming trials and settlement negotiations.

Crux of Olympus Lawsuit Claims

Patients and families harmed by contaminated Olympus duodenoscopes have filed lawsuits in federal and state courts across the country. The claims generally fall into three categories.

1. Design Defect

The core allegation is that Olympus duodenoscopes were defectively designed because their elevator mechanism could not be adequately cleaned using available reprocessing methods. A properly designed reusable device should allow for reliable sterilization between patients. Plaintiffs allege the Olympus scopes did not.

Design defect claims do not always require proof that the manufacturer acted negligently. They require proof that the device was unreasonably dangerous as designed and that a safer alternative design was feasible.

2. Failure to Warn

Olympus knew or should have known that its duodenoscopes posed contamination risks that persisted even when hospitals followed the company’s own reprocessing instructions. The company had a duty to warn physicians, hospitals, and patients of these risks. Plaintiffs allege it failed to do so adequately.

Failure to warn claims are often among the most powerful in medical device litigation because they focus on what the manufacturer knew and when. Internal documents showing that Olympus understood the contamination problem but delayed warnings are central to these claims.

3. Manufacturing Defect

Some claims allege that specific Olympus devices were defectively manufactured, deviating from the company’s design specifications in ways that increased their likelihood of harboring bacteria. The FDA’s findings regarding the Aizu facility support allegations that manufacturing quality control was inadequate.

Who Can File an Olympus Duodenoscope Lawsuit?

If you or a family member underwent an ERCP or another procedure involving an Olympus duodenoscope and subsequently developed a serious infection, you may have a claim. The key questions are:

1. Was an Olympus duodenoscope used during the procedure? Hospital records should document the specific device used. If the records are unclear, the hospital’s risk management or infection control department may be able to confirm.
2. Did you develop an infection within 90 days of the procedure? The most common pattern involves infections that appear within days or weeks after ERCP. Infections requiring hospitalization, IV antibiotics, ICU admission, or surgery are most likely to support a claim.
3. Was the infection caused by a drug resistant organism? Infections involving CRE, VRE, Pseudomonas, Klebsiella, or other resistant bacteria are strongly associated with duodenoscope contamination. Culture results should identify the organism.
4. Did the infection cause significant harm? Patients who died, suffered prolonged hospitalization, required organ transplants, developed kidney failure, or experienced permanent disability have the strongest claims.
5. Is the statute of limitations still open? Each state has its own deadline. The clock may begin when the patient knew or reasonably should have known that the device caused the injury. Because many patients were not told about contamination risks, the discovery rule may matter.

What Compensation Can Victims Recover?

Patients harmed by contaminated Olympus duodenoscopes can seek compensation for:

• Medical expenses: hospital stays, surgeries, medications, rehabilitation, and ongoing care
• Lost wages and earning capacity: income lost during illness and any permanent reduction in the ability to work
• Pain and suffering: physical pain, emotional distress, and diminished quality of life caused by the infection and treatment
• Wrongful death damages: funeral expenses, loss of financial support, loss of companionship, and the suffering the patient endured before death

In cases involving particularly egregious corporate conduct, juries may also award punitive damages where the governing state law permits them and the evidence satisfies the applicable legal standard. Evidence that Olympus knew about contamination risks and delayed action could be relevant to punitive damages in appropriate cases.

These Cases Are Extremely Important

Medical device litigation is sometimes criticized as a tax on innovation or a burden on companies trying to develop life saving technologies. That criticism misses the point of cases like this one.

Olympus is not facing lawsuits because medicine is inherently uncertain. Olympus is facing lawsuits because plaintiffs allege the company designed a device that could not be reliably cleaned, learned that patients were dying, and chose to protect its market share rather than fix the problem or warn the people at risk.

Litigation is the accountability mechanism when regulatory agencies fail and when corporations prioritize profits over patient safety. It is how victims obtain compensation for harms inflicted on them through no fault of their own. It is also how the legal system sends a message to every other medical device manufacturer: a company cannot hide what it knows and escape the consequences.

The Olympus duodenoscope cases are not just about the patients who were infected. They are about what kind of system we want. Do we want a system in which companies can sell defective devices, ignore contamination reports, delay warnings, and face no meaningful consequences? Or do we want a system in which corporate knowledge of danger triggers corporate responsibility to act? These lawsuits are one way of answering that question.

Frequently Asked Questions About Olympus Duodenoscope Lawsuits

What Olympus devices are involved in this litigation?

The main devices at issue are Olympus duodenoscopes used during ERCP procedures, especially the TJF-Q180V and certain related models. Newer claims also involve the TJF-Q190V and other later-generation models. Some claims have also involved other reusable Olympus scopes, including bronchoscopes, laparoscopes, and ureterorenoscopes, as regulators and investigators have examined broader manufacturing and quality control problems.

How do I know if an Olympus scope was used during my procedure?

It is rare that someone knows which scope they used. If you had an ERCP or another endoscopic procedure, your medical records should identify the specific scope that was used. The hospital will have records showing the manufacturer, model, and sometimes the serial number for infection control tracking. If your records are vague or incomplete, our lawyers may still be able to get more details from the hospital’s medical records department, risk management office, or infection control department.

Has Olympus recalled its duodenoscopes?

Olympus has not issued a sweeping recall of all of its duodenoscopes. Instead, the company has issued narrower recalls and corrections involving certain models, accessories, and reprocessing instructions. Our concern is that these narrower actions did not fully address the core design problem. In June 2025, the FDA also imposed import alerts on certain Olympus medical devices manufactured in Japan because of unresolved quality-system concerns.

What is the statute of limitations for filing an Olympus lawsuit?

The deadline depends on your state, and that can make a major difference. In many states, the time limit does not necessarily start on the date of your procedure. Instead, the clock may begin when you knew or reasonably should have known that a contaminated scope or defective device may have caused your injury. That is called the discovery rule. If you were never told about the risk of contamination, or only later learned that your infection may have been connected to the device used during your procedure, that timing could matter.

How long do these cases take to resolve?

Medical device cases often take time because they require medical records, expert review, causation analysis, and detailed evidence about the product itself. Some claims settle earlier than others, especially when the facts are strong and the injuries are well documented. Other cases may take years if they move through discovery, motion practice, and trial preparation.

Do I have to go to court?

Most medical device lawsuits settle before an individual plaintiff’s trial, so most plaintiffs never have to appear in court. That said, if your case moves toward trial, you may be asked to testify about your procedure, your infection, and how the injury affected your life. Your attorney would prepare you for every step.

Olympus Duodenoscope Settlements and Verdicts

Because most Olympus duodenoscope cases have settled under strict confidentiality agreements, publicly available information about settlement amounts is limited. Olympus has been careful to keep financial terms private, likely to avoid establishing benchmarks that could encourage additional claims or increase settlement demands in pending cases.

Regulatory Penalties

In 2018, Olympus Medical Systems Corporation pleaded guilty to failing to file required adverse event reports involving infections connected to duodenoscopes and to continuing to distribute the devices despite those reporting failures. The company was fined $80 million and ordered to pay $5 million in criminal forfeiture. For plaintiffs, that enforcement history matters because it supports the argument that Olympus had repeated regulatory failures, not isolated mistakes.

Separately, in 2016, Olympus paid $646 million to resolve criminal and civil charges related to an illegal kickback scheme involving its medical devices. While that settlement was not directly about duodenoscope contamination, we argue it fits a broader theme of prioritizing profits over regulatory compliance.

Confidential Individual Settlements

Court filings and legal disclosures indicate that Olympus has settled individual cases involving patients who contracted CRE or other drug resistant infections after ERCP procedures. Settlement amounts remain confidential.

What Drives Settlement Value

• Severity of injury: Death, permanent organ failure, prolonged disability, or ICU hospitalization generally increase settlement value.
• Age of the victim: Younger patients who lost decades of earning capacity or life expectancy typically have higher damages.
• Strength of causation: Cases where records clearly document the Olympus scope used, timing of infection, and bacterial strain involved are stronger.
• Defendant conduct: Evidence that Olympus knew about contamination risks and delayed warnings can increase punitive damages risk.
• Jurisdiction: Some states cap damages or have more plaintiff-friendly juries, which sometimes affects settlement negotiations but matters less if there is a global settlement.
• Quality of legal representation: These are complex medical device cases, and experienced counsel can make a meaningful difference.

The lack of publicly reported verdicts means we do not yet have jury determined benchmarks for these cases. That may change if active cases proceed to trial and result in significant plaintiff verdicts.

Contact Us About an Olympus Duodenoscope Claim

If you or a family member developed a serious infection after an ERCP or other procedure involving an Olympus duodenoscope, you may have a claim. Our attorneys handle complex medical device litigation and can evaluate your case at no cost.

Call us at 800-553-8082 or contact us online for a free consultation. We want to hear your story. There is no fee or cost unless we recover compensation for you.