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Endoscope Infection Claims

Contaminated Endoscope Infection Lawsuit

Last Updated: August 8, 2026

Lawsuits allege that reusable duodenoscopes and other flexible scopes cannot be reliably disinfected between patients, and that drug-resistant infections were passed from one patient to the next. These claims are filed individually in state and federal courts nationwide — there is no MDL and no class action.

Reviewed by Ashkaan Hassan, Esq. — CA Bar #283629 Free, no-obligation review No cost to you

A duodenoscope is a reusable flexible scope used in an ERCP, a procedure that reaches the bile duct and pancreas. Lawsuits allege that these scopes and similar reusable endoscopes cannot be reliably disinfected between patients, so drug-resistant bacteria — CRE, Pseudomonas, E. coli, Klebsiella — survive cleaning and infect the next patient. FDA sampling of scopes that had been through the manufacturers' own cleaning instructions found high concern organisms on a measurable share of them. Unlike most mass torts, these claims are not consolidated: each is filed individually in state and federal courts nationwide, so your state's filing deadline governs. NuLegal reviews these claims at no cost and connects qualified claimants with trial counsel handling this litigation.

Background

The Device, and Why It Is Hard to Clean

A duodenoscope is a flexible tube with a camera at the end, passed through the mouth and stomach to reach the bile duct and pancreas. The procedure is an ERCP — endoscopic retrograde cholangiopancreatography — and it is how a blocked duct is opened, a stuck gallstone removed, or a pancreatic problem investigated. Hundreds of thousands are performed in the United States every year.

Unlike a needle or a catheter, the scope is not thrown away afterwards. It is cleaned and disinfected according to the manufacturer's written instructions and used on the next patient. What plaintiffs allege is that the design makes that impossible to do reliably: the scope has long narrow channels, and at the tip of a duodenoscope there is a hinged part called the elevator mechanism that steers instruments into the duct. It has crevices a brush cannot reach, and it sits in the part of the device that has just been inside a duct carrying bile and bacteria.

The claims are brought against Olympus Corporation of the Americas, Fujifilm Medical Systems U.S.A., Inc. and Pentax of America, Inc, and in some cases against the facility that performed the procedure. That a design defect caused any particular infection is an allegation under litigation, not an established finding.

How These Cases Are Filed

There Is No MDL for These Claims

If you have read about mass torts before, you have probably read about an MDL — hundreds or thousands of cases gathered before one federal judge for coordinated pretrial work. That does not exist here. There is no MDL for endoscope infection claims, no docket number, no judge managing them all, and no class action. Each case is filed on its own, in state and federal courts nationwide.

Two consequences follow, and both are practical rather than academic.

Your state's filing deadline governs, and nothing else extends it. In a consolidated proceeding a claimant can sometimes be carried along by the schedule of the litigation as a whole. Here the clock is your state's own statute of limitations, and whether it starts at the infection or at the point you connected it to the procedure depends on your state's discovery rule. The state pages below set out both.

Timing is driven by your case, not by a bellwether calendar. There is no first trial whose outcome sets a benchmark for everyone else, which cuts both ways — nothing is waiting on another case's schedule, and nothing is being coordinated on your behalf either.

Reported Injuries

Infections Reported in These Claims

Most patients are never told which organism they had. If you were readmitted after a scope procedure for an infection that did not respond to the first antibiotics tried, the screening below will walk through the details that matter — you do not need to know the name.

Carbapenem-Resistant Infection (CRE)

An infection by a bacterium that resists carbapenems, the antibiotics normally held in reserve for organisms nothing else will treat. CRE is the organism most associated with the duodenoscope outbreaks that opened this litigation, and it is what makes a scope-transmitted infection different in kind from an ordinary post-procedure one — the treating team may find that the drugs they would reach for do not work.

Common signs

  • Fever and chills beginning days to weeks after the procedure
  • Abdominal or back pain that was not there before
  • Jaundice, or a return of jaundice that had been resolving
  • An infection that does not respond to the first or second antibiotic tried
  • Repeated readmission for the same infection

How it is identified: Culture of blood, bile, or another sterile site, followed by susceptibility testing that shows resistance to carbapenems.

Severity: Serious — carbapenem resistance narrows the treatable options sharply, and these infections are often managed in an intensive care setting.

Sepsis and Septic Shock

The body's own response to an infection turning against its organs. Sepsis is the way a scope-transmitted infection most often becomes an emergency, and because an ERCP reaches the bile duct, an infection seeded there can move into the bloodstream quickly.

Common signs

  • High fever, or an unusually low body temperature
  • Rapid heartbeat and rapid breathing
  • Confusion or disorientation
  • A sharp drop in blood pressure
  • Reduced urine output

How it is identified: Clinical criteria for organ dysfunction alongside a suspected or confirmed infection, supported by blood cultures and lactate testing.

Severity: Life-threatening — septic shock is treated as a medical emergency and frequently requires intensive care.

Pseudomonas Infection

An infection by Pseudomonas aeruginosa, an organism that survives in moisture and is repeatedly recovered from endoscope channels and from the machines used to reprocess them. It is one of the organisms FDA surveillance classes as high concern when found on a reprocessed duodenoscope.

Common signs

  • Fever following the procedure
  • Infection at a surgical or catheter site
  • Pneumonia in a patient who was not previously respiratory-compromised
  • An infection that keeps returning after treatment appears to work

How it is identified: Culture from blood, bile, respiratory secretions, or another affected site, with organism identification and susceptibility testing.

Severity: Varies from a treatable localized infection to a severe systemic one; multidrug-resistant strains are materially harder to treat.

E. coli Infection

An infection by Escherichia coli, including the strains that produce extended-spectrum beta-lactamases and are therefore resistant to a broad class of antibiotics. E. coli is named in FDA sampling of reprocessed duodenoscopes as an example of a high concern organism recovered after cleaning.

Common signs

  • Fever, chills, and abdominal pain after the procedure
  • A urinary or bloodstream infection with no other apparent source
  • Cholangitis — infection of the bile ducts
  • Sepsis developing from any of the above

How it is identified: Culture of blood, bile, or urine identifying E. coli, with susceptibility testing to establish whether a resistant strain is involved.

Severity: Serious when it reaches the bloodstream or the biliary tract; resistant strains restrict treatment options considerably.

Prolonged Hospitalization and IV Antibiotic Treatment

Not a disease but a harm, and it is in this list because it is what most of these claims actually consist of. A resistant infection acquired from a scope is treated with weeks of intravenous antibiotics, often through a line placed for that purpose, and often after a readmission — the cost, the lost work, and the second procedure are the injury even where the patient ultimately recovers.

Common signs

  • Readmission within days or weeks of the original procedure
  • A course of IV antibiotics measured in weeks rather than days
  • Placement of a PICC line or central line to deliver them
  • Additional procedures to drain or wash out the infected site
  • A recovery that took months longer than the procedure was supposed to require

How it is identified: Established by the treatment record rather than by a test — the admission history, the antibiotic course, and the readmission dates.

Severity: Depends on the length of the course and on what the infection damaged before it was controlled.

Death

The duodenoscope outbreaks reported at U.S. hospitals included patient deaths, and where a resistant infection acquired from a contaminated scope contributed to a death, the claim is brought by the estate or by surviving family under the applicable wrongful-death statute rather than by the patient.

Common signs

  • A resistant infection that could not be brought under control
  • Multi-organ failure following septic shock
  • Death during or shortly after an admission for a post-procedure infection

How it is identified: Established from the medical record and the death certificate, read together with the culture results and the procedure history.

Severity: The wrongful-death deadline is frequently shorter than the personal-injury one and can run from the date of death rather than from the date the connection was discovered — timing should be checked immediately.

The Regulatory Record

What the FDA Has Actually Found

There is no court ruling to report here, so what follows is the regulatory record instead — and it is stated as what it is. The FDA ordered all three manufacturers to sample and culture duodenoscopes that had been through the manufacturers' own reprocessing instructions, in real hospitals, after real procedures.

In a safety communication dated December 10, 2018, the FDA reported interim results of up to 3% of properly collected samples testing positive for what it terms high concern organisms — those more often associated with disease — and up to 3% positive for enough low concern organisms to indicate a reprocessing failure. The FDA described the rates as higher than expected.

Later results reported 4.1% to 6.6% of samples from the older fixed-endcap designs positive for high concern organisms including E. coli, against 0.5% for a design with a removable cap. The FDA recommended that facilities and manufacturers transition to duodenoscopes with disposable components, and Olympus and Pentax withdrew their fixed-endcap models from the market.

What that is and is not. It is FDA sampling data about the devices as a class, and it is the reason these claims exist. It is not a finding that any particular patient's infection came from a particular scope. That question is answered case by case, from the facility's device log, the reprocessing records, and the culture results.

Fixed-endcap scopes

4.1%–6.6%

of samples positive for high concern organisms after reprocessing

Removable-cap design

0.5%

the comparison that drove the FDA's recommendation

Consolidation

None

cases are filed individually; your state's deadline governs

Two other regulatory actions, and what they are not

Both are frequently cited in coverage of this litigation, and both are narrower than they are made to sound. On June 24, 2025 the FDA issued import alerts covering certain Olympus devices made at the company's Aizu plant in Japan — bronchoscopes, laparoscopes, ureterorenoscopes and automated endoscope reprocessors — over quality-system violations. Duodenoscopes are not among them. Separately, in a customer letter dated February 12, 2026, later classified by the FDA as a Class II correction, Olympus advised that its MAJ-1443 and MAJ-1444 valves may no longer be high-level disinfected in the OER-Pro and OER-Elite automated reprocessors and must be reprocessed by other validated methods. Those valves are for ultrasound endoscopes, and Olympus states it had received no complaints about them related to reprocessing or infection. Neither action is evidence that any claimant was infected, and this page does not present them as such.

Eligibility

What a Review Looks At

Two facts decide whether a claim fits, and a third set of details is helpful but genuinely optional. If you are unsure about any of them, say so on the form — an unknown answer routes the file to a person rather than closing it.

You had a scope procedure

An ERCP, an upper endoscopy, a colonoscopy, or a similar procedure using a flexible scope. If you are not certain what it was called, the facility's records name it.

An infection followed

You developed an infection afterwards. "An infection" or "I went septic" is a complete answer — you are not expected to know what it was called.

Roughly when each happened

The year of the procedure and the year the infection started. Approximate is fine, and a long gap between them does not rule you out; it goes to a person to look at.

The records can be requested

The facility holds the device log, the reprocessing records, and the culture results. You do not need any of them today — knowing roughly where the procedure happened is enough, and even that is not required.

Before You Rule Yourself Out

Three Things You Do Not Need to Know

People talk themselves out of these claims on details they were never going to have, so this section exists to say plainly which ones do not matter.

Who made the scope

Almost nobody knows this, and you are not expected to. The hospital's device log records which manufacturer's scope was used and its serial number. That document is obtained during the case.

What the infection was called

Most patients are told they had an infection, or that they went septic, and never hear a name like carbapenem-resistant Klebsiella. The culture result is in the hospital's records.

Exactly where it was done

If the procedure was years ago and you cannot name the hospital, that is a normal answer. It can be traced from your medical and insurance records.

The screening below offers "I don't know" for all three, and none of those answers counts against a claim. What it does need is whether there was a scope procedure and whether an infection followed.

Qualification Tool

Check If You Qualify

A few questions about the procedure and the infection. "I don't know" is an accepted answer to most of them. Nothing you answer here creates an attorney-client relationship.

Free case review

Who is this claim for?

If the person who was harmed has died, a surviving family member or the estate can bring the claim. The deadline can be different in that case, so it goes to a person to look at — it does not rule anything out.

Common Questions

Endoscope Infection FAQ

What is a duodenoscope, and what is an ERCP?

A duodenoscope is a flexible, camera-tipped tube passed through the mouth and stomach to reach the bile duct and pancreas. The procedure it is used for is called an ERCP — endoscopic retrograde cholangiopancreatography — and it is how doctors clear a blocked bile duct, remove a stuck gallstone, or investigate the pancreas. It is a common procedure and for most people an uneventful one. What makes this device different from a simpler scope is a hinged part at the tip called the elevator mechanism, which steers instruments into the duct and has crevices that are extremely difficult to clean.

What do these lawsuits allege?

That these scopes cannot be reliably disinfected between patients, and that the manufacturers knew it. The scopes are reusable and are cleaned according to the manufacturer's own written instructions between one patient and the next. Plaintiffs allege that the design — the closed channels, and on a duodenoscope the elevator mechanism — traps organic material and bacteria where the cleaning process cannot reach, so an organism from one patient can survive reprocessing and reach the next. These are allegations being litigated. No court has determined that any manufacturer's design caused any particular infection.

Is there an MDL for endoscope infection cases?

No, and that is a genuine difference from most of the mass torts you may have read about. There is no federal MDL and no class action for these claims. Each case is filed individually, against 3 device manufacturers and sometimes against the facility, in state and federal courts nationwide. That has two practical consequences. First, your own state's filing deadline governs, and it is not extended by anyone else's case — the state pages below set out what applies where you live. Second, no single judge sets a schedule for everyone, so timing is driven by the individual case rather than by a bellwether calendar.

Has the FDA found a problem with these devices?

The FDA ordered all three manufacturers to sample and culture duodenoscopes that had been through the manufacturer's own reprocessing instructions, and the results are what most of the concern rests on. In a safety communication dated December 10, 2018 the FDA reported interim results of up to 3% of properly collected samples testing positive for high concern organisms — the FDA's term for organisms more often associated with disease — and up to 3% positive for enough low concern organisms to indicate a reprocessing failure. Later results put the rate at 4.1% to 6.6% for the older fixed-endcap designs against 0.5% for a design with a removable cap, and the FDA recommended that facilities move to duodenoscopes with disposable components. Olympus and Pentax withdrew their fixed-endcap models. These are findings about the devices as a class, from FDA sampling. They are not a finding about any individual patient's infection.

I have no idea which company made the scope. Can I still have a case?

Yes, and this is the question worth reading carefully. Nobody is told the manufacturer of a device that was inside them for forty minutes. It is recorded in the hospital's device log, alongside the serial number of the exact scope used and the record of how it was cleaned, and those documents are obtained during the case rather than supplied by you. The same is true of the organism: most patients are told they had "an infection" or that they went septic, and never hear a name like carbapenem-resistant Klebsiella. The screening below offers "I don't know" for the manufacturer, for the organism, and for the facility, and none of those answers counts against a claim.

What kinds of infection are involved?

The organisms most associated with these outbreaks are antibiotic-resistant ones: carbapenem-resistant Enterobacteriaceae, usually shortened to CRE, along with Pseudomonas, E. coli and Klebsiella. What follows from them ranges from an infection that needed weeks of IV antibiotics to sepsis, septic shock, and in reported outbreaks, death. If you were readmitted after a scope procedure for an infection that did not respond to the first antibiotics tried, that is the pattern these claims are about.

How long after the procedure would the infection have started?

Usually days to weeks, but there is no fixed rule and a longer gap does not close a review. Whether an infection is attributable to a procedure is a medical question answered by the records — the culture results, the timing, and whether the same organism was found on the scope or in other patients at that facility. The screening asks for both years and sends the file to a person; it does not apply an arithmetic cutoff.

What does a case review cost?

Nothing. NuLegal's case review is free and carries no obligation. NuLegal reviews the claim and, where it qualifies, connects the claimant with trial counsel handling this litigation. Submitting the form does not create an attorney-client relationship.

Don't Wait

With no consolidated proceeding to carry a case along, your state's filing deadline is the only clock that matters. A free, no-obligation review takes a few minutes and tells you whether your claim fits.

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Disclosure: NuLegal operates as a legal referral service. Attorney Ashkaan Hassan evaluates claims and refers qualified cases to specialized trial firms, earning a referral fee from the attorney's share of any recovery. Clients never pay out of pocket.