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Endoscope Infection Claims Are Filed Individually, Not Consolidated

endoscope-infection duodenoscope ercp litigation-update fda

Why These Claims Do Not Look Like the Other Mass Torts

If you have read anything about Depo-Provera, Ozempic, or Bard PowerPort litigation, you have read about MDLs — federal cases pooled before one judge, with bellwether trials and coordinated discovery. Contaminated endoscope infection claims work differently.

There is no MDL and no class action for endoscope and duodenoscope infection claims. They are filed individually, one patient or family at a time, in state and federal courts. Some lawsuits against scope manufacturers have been reported publicly, including cases described in industry coverage as involving infection and sepsis after ERCP procedures. But there is no consolidated proceeding gathering them, no master docket, and no single judge managing them together.

That is not a technicality. It changes almost everything about how a case is built, where it is filed, and how long it takes.

What These Lawsuits Allege

The reported cases generally involve patients who underwent ERCP (endoscopic retrograde cholangiopancreatography) or another procedure using a reusable flexible scope, and who then developed a serious infection — including drug-resistant organisms such as CRE and other carbapenem-resistant bacteria, Pseudomonas, E. coli, Klebsiella, and, in at least one lawsuit reported by trade press, vancomycin-resistant enterococcus. Some patients developed sepsis. Some died.

Plaintiffs have alleged that the design of certain reusable duodenoscopes — particularly the movable elevator mechanism at the tip — makes the device difficult to fully clean between patients even when staff follow the manufacturer’s reprocessing instructions, and that the manufacturers’ cleaning instructions and warnings were inadequate.

These are allegations that are being litigated. No court has resolved them, and describing a design theory is not the same as establishing that a device caused a particular infection. Manufacturers dispute these claims. Causation in any individual case turns on that patient’s records, the organism involved, and the facts of the facility and the procedure.

Why Reprocessing a Duodenoscope Is Difficult

A duodenoscope is a long, flexible, side-viewing instrument threaded through the mouth to the top of the small intestine so a physician can reach the bile and pancreatic ducts. ERCP is used to treat gallstones in the bile duct, strictures, leaks, and certain pancreatic and biliary conditions. The National Institute of Diabetes and Digestive and Kidney Diseases publishes patient-level background on these digestive procedures and conditions.

Unlike a syringe, the scope is not thrown away. It is cleaned, disinfected, and used again. The instrument contains narrow internal channels and, at the tip, a hinged elevator that changes the angle of instruments passed through it. Those crevices are the part of the device that has drawn regulatory and litigation attention.

The Centers for Disease Control and Prevention maintains general guidance on healthcare-associated infections and antibiotic-resistant organisms, which explains why a resistant infection acquired in a hospital setting can be so difficult to treat.

Recent Regulatory Activity — and What It Does Not Prove

The U.S. Food and Drug Administration has issued a series of communications over the years regarding duodenoscope reprocessing, postmarket surveillance studies, and manufacturer responsiveness to complaints. Reporting has also described the agency encouraging a transition toward duodenoscope designs with disposable components. Attribute any specific figure to the FDA communication it came from, and read the scope of each action carefully — they are not interchangeable.

Two recent items are frequently misread:

  • A June 2025 Olympus import alert covered bronchoscopes, laparoscopes, ureterorenoscopes and reprocessing equipment — not duodenoscopes. It is not evidence that any duodenoscope infected anyone.
  • A February 2026 correction involving Olympus MAJ-1443 and MAJ-1444 valves was reported with the company stating it had received no complaints of infection connected to the issue.

Regulatory activity describes what an agency asked a company to do. It is not a finding that a specific patient’s infection came from a specific device, and no honest summary should present it that way.

Your Own State’s Law Does More Work Here Than in Other Litigation

Because there is no consolidated proceeding, the law of the state where you were treated or where you live is unusually decisive. States differ on questions that can determine whether a case can be brought at all:

  • How long you have to file. Deadlines for product liability, medical negligence, and wrongful death claims vary by state, and they are not always the same length as one another.
  • When the clock starts. Many states apply some version of a discovery rule, but the details differ — and for an infection identified weeks after a procedure, when the clock began can be genuinely contested.
  • How the claim is characterized. A case framed against a device manufacturer and a case framed against a hospital or provider can fall under different statutes, different procedural requirements, and in some states different pre-filing steps such as expert affidavits.
  • Who may bring a wrongful death claim, and what damages are recoverable.

This is why a general article cannot tell you whether your claim is timely. The honest answer is that it depends on facts specific to you, and it is worth having someone look at the dates promptly rather than assuming the window has closed.

You can read more about how these cases are evaluated on our endoscope infection page.

You Do Not Need to Know the Manufacturer, the Organism, or Even the Facility

This is the single most common reason people talk themselves out of calling.

Patients tell us they cannot pursue anything because they do not know whether the scope was an Olympus, Fujifilm, or Pentax device. They do not remember the name of the bacteria. They were transferred between hospitals and are not certain where the procedure happened.

None of that disqualifies you. Those details live in records:

  • The procedure note and endoscopy log typically identify the scope, often down to the serial number.
  • Microbiology and culture results identify the organism and its resistance pattern.
  • Infection control and reprocessing records at the facility document how the device was handled.
  • Hospital billing records can reconstruct where and when a procedure occurred.

Gathering those records is part of the work of evaluating a claim. Not remembering them is normal — especially for a family member piecing together what happened during a critical illness.

What Is Worth Preserving Now

If you or a family member developed a serious infection after an endoscopic procedure, a few practical steps help:

  • Write down approximate dates — the procedure, when symptoms began, when you were readmitted.
  • Keep discharge summaries, lab reports, and antibiotic records, including anything that names a resistant organism.
  • Note every facility involved, including transfers and any second hospital that treated the infection.
  • Save correspondence from the hospital, including any letter notifying patients of a possible exposure.

Do not delay medical care to preserve a claim, and do not stop treatment. Documentation matters, but your health comes first.

When a Patient Has Died

Some of the reported endoscope cases are wrongful death claims brought by surviving family members. These claims are governed by state statutes that define who may sue — often a personal representative of the estate, or a defined class of surviving relatives — and what may be recovered.

Wrongful death deadlines are frequently shorter than other deadlines and sometimes run from the date of death rather than from the procedure. If you are a spouse, parent, or adult child considering this, the timing question deserves attention early. General information about the federal court system is available from the Administrative Office of the U.S. Courts, and published medical literature on duodenoscope-associated infections can be searched through PubMed.

What to Expect Realistically

Because each case stands on its own, there is no bellwether calendar to point to and no coordinated settlement structure to describe. Individually filed cases move at the pace of the court they are in, and outcomes depend on the evidence in that specific case.

We will not tell you what your claim is worth, and you should be cautious of anyone who does before reviewing your records. What we can do is look at the dates, obtain the records that identify the device and the organism, and give you a straight answer about whether there is a viable claim under the law that applies to you.

Take the Next Step

If you developed a drug-resistant infection or sepsis after an ERCP or another procedure involving a reusable flexible scope — or if you lost a family member after one — a review of your records can tell you where you stand, including whether a filing deadline is approaching in your state.

Request a free, confidential case review. There is no cost to have someone look at the timeline, and no obligation to move forward.

This article is general information, not legal or medical advice. It does not create an attorney-client relationship, and no outcome is promised or implied.

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This content is provided for informational purposes only and does not constitute legal advice. NuLegal | Ashkaan Hassan, Esq. | CA Bar #283629

Disclosure: NuLegal operates as a legal referral service. Qualified cases are referred to specialized trial firms; NuLegal earns a referral fee from the attorney's share of any recovery. Clients never pay out of pocket.