Michigan Duodenoscope and Flexible Endoscope Infection Lawyer

You went in for a routine ERCP or upper GI procedure. A few days or weeks later you were back in the hospital with a fever, a blood infection, or something far worse — sepsis, CRE, cholangitis, organ failure. The scope that was supposed to help diagnose or treat you may have carried bacteria from a prior patient, and the infection you developed may be the direct result of a device that cannot be reliably cleaned between uses.
These are not ordinary medical malpractice cases. They sit at the intersection of Michigan product liability law, medical negligence, and hospital reprocessing failures — and the evidence disappears quickly. At Neumann Law Group, our attorneys investigate duodenoscope and flexible endoscope infection claims across Michigan, working with infectious disease experts and medical device engineers to identify exactly how a patient was exposed and who is responsible. If you or a family member developed a serious infection after an endoscopic procedure in Michigan, you have a limited window to act.

What is a duodenoscope infection case?

A duodenoscope is a flexible, lighted tube used during endoscopic retrograde cholangiopancreatography (ERCP) to diagnose and treat problems in the bile ducts, pancreas, and gallbladder. Duodenoscopes are used in approximately 500,000 to 700,000 ERCP procedures in the United States each year, according to FDA estimates and gastroenterology society data. The device has an elevator mechanism at the tip — a complex hinged component that is notoriously difficult to clean.

The problem is this: duodenoscopes and certain other flexible endoscopes are reusable, but the intricate channels and the elevator wire can trap biological material that disinfection does not always reach. When the next patient is scoped, bacteria from the prior patient — sometimes multidrug-resistant organisms like carbapenem-resistant Enterobacteriaceae (CRE) — can be introduced directly into the biliary tree or duodenum. FDA postmarket surveillance has documented higher-than-expected contamination rates after reprocessing, including in samples from facilities that reported following the manufacturer’s reprocessing instructions, leading the agency to recommend transition to duodenoscopes with disposable components.

Patients injured by these devices have developed bacteremia, sepsis, cholangitis, pneumonia, pancreatic infections, and in the worst cases, organ failure and death. The legal claims that flow from these injuries typically involve a combination of product defect, failure to warn, and hospital reprocessing negligence.

What legal claims can a Michigan patient bring after a duodenoscope infection?

Michigan law recognizes several overlapping theories in these cases, and a thorough investigation usually pursues more than one.

Product liability against the device manufacturer. Under Michigan’s product liability statute (MCL 600.2946), a manufacturer can be held responsible for a defectively designed product, for failing to warn of known risks, or for manufacturing defects. Duodenoscope claims often center on design — specifically, whether the elevator mechanism and internal channels can be reliably disinfected under real-world hospital conditions. They also involve failure-to-warn theories, since manufacturers have faced years of FDA warnings and postmarket surveillance data suggesting their reprocessing instructions were inadequate.

Medical malpractice against the hospital or physician. If the facility deviated from its own reprocessing protocols, skipped required steps, failed to quarantine a scope after a suspected contamination event, or ignored culture results, a Michigan medical malpractice claim may apply. These claims are governed by MCL 600.2912b (the notice-of-intent requirement) and MCL 600.2912d (the affidavit-of-merit requirement). The statute of limitations runs under MCL 600.5838a — generally two years from the act or omission, with a six-month discovery extension and a six-year outer statute of repose.

Negligence against the reprocessing entity. Some hospitals outsource scope cleaning. Others use automated endoscope reprocessors (AERs) that themselves may have been defective or poorly maintained. A separate negligence claim may lie against these entities.

The right combination depends on what the evidence shows. In our experience, no single theory fits every case — the facts drive the legal strategy.

How does Michigan’s product liability statute apply to duodenoscope infection cases?

Michigan’s product liability framework is among the more defense-friendly in the country, but it is not an impenetrable shield. MCL 600.2946 requires a plaintiff to prove that the device was not reasonably safe and that a practical and technically feasible alternative design would have reduced the risk. In duodenoscope cases, the alternative-design argument has real traction: single-use disposable duodenoscopes now exist on the market, and several manufacturers have transitioned or supplemented their product lines in response to the contamination crisis.

Michigan formerly had a statutory defense for FDA-approved drugs under MCL 600.2946(5); that subsection was repealed by Senate Bill 410 effective February 13, 2024, and in any event applied to drugs — not medical devices. Device cases proceed under the general design-defect and warning framework, and the FDA’s own adverse-event reporting and recall history often becomes powerful evidence against the manufacturer.

The statute of limitations for product liability claims in Michigan is three years from the date of injury under MCL 600.5805. For a patient who developed a post-ERCP infection, that clock typically starts when the infection was diagnosed or reasonably should have been — not the date of the procedure itself.

What should I do right now if I think a scope infection hurt me?

Evidence in these cases evaporates. Hospitals rotate scopes in and out of service, reprocessing logs get overwritten, and culture samples get discarded. The most important thing is to preserve the record before it disappears.

Request your complete medical records — not just the discharge summary, but the full operative report, anesthesia record, and nursing notes from the endoscopy suite. Ask specifically for the device tracking log for the scope used in your procedure, including manufacturer, model, and serial number. Request infection-control records, any internal incident reports, and the results of every culture drawn during your subsequent hospitalization. If you developed a bloodstream infection, the blood culture speciation and antibiotic sensitivities are critical.

Write down the timeline while it is fresh: the procedure date, the facility, the name of the gastroenterologist, when your symptoms started, and every provider you saw afterward. Do not sign releases from the hospital’s risk management office or the manufacturer’s claims department without legal advice. These documents are routinely drafted to limit your rights, and once signed, they are hard to undo.

How do we prove that a specific scope caused a specific infection?

Causation is where these cases are won or lost. It is not enough to show that a patient had an ERCP and later developed an duodenoscope infection — the defense will argue the bacteria could have come from anywhere. Our investigation generally focuses on four evidentiary pillars.

1. Product identification

We work with the hospital’s device tracking system to identify the exact scope used in your procedure, down to the serial number. This matters because FDA recalls and manufacturer safety communications are often model-specific. The Olympus EVIS EXERA III Duodenovideoscope model TJF-Q190V — covering all serial numbers in commerce — has been the subject of recall and field-action notices tied to updated reprocessing instructions. If your procedure involved a recalled device, that changes the analysis significantly.

2. Microbial matching

If the organism cultured from your blood, bile, or tissue matches an organism previously cultured from the same scope or from prior patients exposed to the device, that is powerful circumstantial evidence. Hospitals are supposed to investigate contamination clusters, but those investigations do not always make their way into a patient’s chart. We pull the microbiology data, the prior-patient culture history where available, and the scope-surveillance cultures.

3. Reprocessing compliance

We examine the facility’s cleaning logs, staffing, and training records for deviations from the manufacturer’s instructions. FDA postmarket surveillance studies of duodenoscope reprocessing — first reported in 2018 and updated through 2019 — found high-concern organism contamination rates between 4.1% and 6.6% on Olympus and Pentax fixed-endcap models, prompting the agency’s recommendation that hospitals transition to duodenoscopes with disposable components. Olympus’s October 17, 2025 Urgent Field Safety Notice further admitted that prior reprocessing instructions “required updates to minimize potential deviations,” introduced new 10x-magnification visual inspection requirements, and confirmed reports of two deaths and five serious injuries from 2024 to 2025 linked to its TJF-series duodenoscopes. These figures provide a baseline for what reasonable facilities should have been catching, escalating, and disclosing.

4. Differential diagnosis

Infectious-disease experts help rule out alternative sources — urinary catheters, central lines, pre-existing colonization — so the defense cannot credibly point elsewhere. In medically fragile patients, this work is especially important.

What damages can I recover in a Michigan scope infection case?

Michigan law allows recovery of economic damages (medical bills, future medical care, lost wages, lost earning capacity) and non-economic damages (pain and suffering, loss of enjoyment of life, disfigurement). If a family member died from the infection, a wrongful death claim can be brought under MCL 600.2922 by the personal representative of the estate, with recoverable damages including pain and suffering of the deceased before death, loss of financial support, and loss of companionship for surviving spouses and dependents.

Non-economic damages in medical malpractice claims are subject to a statutory cap under Michigan law, with a higher tier available for catastrophic injuries. Product liability claims against the device manufacturer are not subject to that cap, which is one reason pursuing the product theory — when the facts support it — can meaningfully change the value of a case.

Why patients choose Neumann Law Group

Medical device cases require more than a personal injury law firm willing to take the case. They require attorneys who understand FDA regulatory history, who can depose infection preventionists and biomedical engineers, and who have the resources to retain the experts these cases demand. Our team handles complex product liability and medical malpractice matters across Michigan from our offices in Traverse City, Grand Rapids, and Detroit, as part of our broader personal injury practice.

If a loved one died as a result of a scope infection, our attorneys also handle wrongful death claims and can walk you through the probate and personal representative process Michigan requires before a wrongful death lawsuit can be filed.

Talk to a Michigan duodenoscope infection lawyer today

If you or a family member developed a serious infection after an ERCP, upper GI endoscopy, or other procedure involving a flexible scope, do not wait to get legal advice. Evidence disappears, records get archived, and statutory deadlines run out fast in medical device cases. Call Neumann Law Group at (800) 525-6386 for a free consultation. We take these cases across Michigan from our offices in Traverse City, Grand Rapids, and Detroit, and there is no fee unless we recover for you.

Frequently asked questions about duodenoscope infection cases

Q: How long do I have to file a scope infection lawsuit in Michigan?

A: Product liability claims generally must be filed within three years under MCL 600.5805. Medical malpractice claims typically must be filed within two years under MCL 600.5838a, subject to a six-month discovery extension and a six-year outer statute of repose. The clock may start when the infection was reasonably discoverable, not the procedure date.

Q: What organisms are most commonly linked to duodenoscope infections?

A: CRE (carbapenem-resistant Enterobacteriaceae), Pseudomonas aeruginosa, E. coli, and Klebsiella are commonly reported. The CDC has specifically linked duodenoscope exposure to CRE transmission because the device’s complex design makes it harder to disinfect than standard endoscopes.

Q: Can I sue the hospital, the doctor, and the scope manufacturer?

A: Often yes. These cases frequently involve overlapping claims against the device manufacturer under Michigan product liability law, the hospital for reprocessing failures, and sometimes the physician if the procedure itself deviated from the standard of care.

Q: What is the Olympus duodenoscope recall and field action?

A: The FDA has posted recall and field-action notices for the Olympus EVIS EXERA III Duodenovideoscope model TJF-Q190V — covering all serial numbers in commerce — tied to updated reprocessing instructions. Olympus’s October 17, 2025 Urgent Field Safety Notice further acknowledged that prior reprocessing instructions required updates, introduced new 10x-magnification visual inspection requirements, and confirmed reports of two deaths and five serious injuries from 2024 to 2025 linked to its TJF-series duodenoscopes. Current FDA postmarket surveillance places high-concern contamination rates between 4.1% and 6.6% on Olympus and Pentax fixed-endcap models.

Q: Do I have a case if I had other risk factors for infection?

A: Possibly. Many ERCP patients are medically fragile — that is why they are having the procedure. A thorough case investigation uses infectious disease experts and differential diagnosis to distinguish scope-related infections from other sources. Underlying illness does not automatically defeat a claim.

Q: What if my family member died after a scope procedure?

A: Michigan wrongful death claims are governed by MCL 600.2922 and must be filed by the personal representative of the estate. Recoverable damages include medical and funeral expenses, pain and suffering of the deceased, loss of financial support, and loss of companionship for surviving family.