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Nationwide Case Review · 2026

Infected After an Endoscopy or ERCP Procedure?
Cornerstone Law Can Help.

New FDA safety alerts targeting Olympus, Pentax, and Fujifilm sparked a surge in duodenoscope infection litigation in 2025–2026. A California consolidated action is in active discovery, hospitals are being named as co-defendants, and the JPML is considering MDL formation. Cornerstone Law is reviewing cases nationwide — with no upfront cost to you.

Duodenoscopes — complex medical devices used in ERCP procedures — have been linked to outbreaks of drug-resistant infections including CRE and ESBL-producing bacteria. Plaintiffs allege the devices were defectively designed and impossible to fully sterilize, that manufacturers concealed contamination risks, and that hospitals failed to follow proper reprocessing procedures. This chain of alleged negligence has caused severe and sometimes fatal infections in patients who underwent routine procedures.
3 Major manufacturers named (Olympus, Pentax, Fujifilm)
2025 CMO issued; discovery of internal contamination data ordered
MDL JPML actively considering centralization
CRE & ESBL Drug-resistant bacteria linked to outbreaks

Which Manufacturers and Parties Are Being Sued?

Lawsuits name the three major duodenoscope manufacturers whose devices have been the subject of FDA safety alerts and recalls. In an expansion of the litigation, several hospitals are now also being named as co-defendants for failing to follow manufacturer and FDA reprocessing protocols.

OlympusPrimary manufacturer defendant
Pentax MedicalNamed in FDA alerts
FujifilmNamed in FDA alerts
Hospital Co-DefendantsNegligent reprocessing

Where the Litigation Stands Now

A consolidated action in California is in active discovery under a 2025 case management order, and the JPML is weighing whether to centralize rising federal filings into a formal MDL.

In re: Duodenoscope Infection Litigation

Case No. 2:25-cv-00911 — Central District of California

2025 case management order requires production of design-change documents, internal contamination-rate data, communications with the FDA, and field-correction and recall records. Discovery is active and ongoing.

JPML Centralization Under Consideration

Proposed MDL — venue TBD

Rising case volume has prompted the Judicial Panel on Multidistrict Litigation to consider creating a new MDL. MDL formation would coordinate discovery nationwide and is widely anticipated as filings continue to grow.

Discovery is already producing critical internal documents. Internal contamination-rate data and FDA communications being ordered now will form the evidentiary foundation of the entire litigation. Filing early helps position your claim ahead of MDL formation and pretrial rulings.

A Chain of Alleged Negligence

Plaintiffs describe a chain of failures involving manufacturers, regulators, and hospitals that left patients unknowingly exposed to dangerous drug-resistant bacteria during routine medical procedures.

Defective Design

Duodenoscopes have complex elevator mechanisms with crevices that trap organic material and can't be fully cleaned, a design flaw plaintiffs allege manufacturers knew about for years.

Impossible to Sterilize

The device's architecture allegedly made complete sterilization unachievable even when following manufacturer instructions, creating a persistent contamination risk across patients.

Concealed Contamination Risks

Plaintiffs allege manufacturers had internal data on contamination rates and infection outbreaks but failed to disclose this to hospitals, physicians, or the FDA in a timely manner.

Hospital Reprocessing Failures

Several hospitals are named as co-defendants for allegedly failing to follow FDA-required reprocessing protocols, letting contaminated scopes be used on subsequent patients.

Drug-Resistant Outbreaks

The result: outbreaks of CRE and ESBL-producing bacteria, among the most dangerous drug-resistant organisms, in patients who underwent procedures they trusted to be safe.

Failure to Warn and Recall

Despite accumulating evidence of infection risk, manufacturers allegedly delayed issuing adequate warnings and field corrections, prolonging patient exposure to known contamination hazards.

Do You Have a Case? Who May Qualify?

You may qualify if you underwent an endoscopy or ERCP procedure and subsequently developed a serious infection or related complication. Both patients with a confirmed drug-resistant diagnosis and those hospitalized for an unexplained post-procedure infection may be eligible.

Qualifying Conditions

  • CRE (carbapenem-resistant Enterobacteriaceae) infection
  • ESBL (extended-spectrum beta-lactamase) infection
  • Sepsis following endoscopy or ERCP
  • Hospitalization due to post-procedure infection
  • Long-term organ damage linked to infection

General Eligibility Factors

  • Underwent an endoscopy or ERCP procedure
  • Procedure performed using an Olympus, Pentax, or Fujifilm duodenoscope
  • Developed a qualifying infection or complication after the procedure
  • Infection or hospitalization documented in medical records

Liability and What You Can Recover

Liability Legal Theories

  • Defective design
  • Failure to warn
  • Negligent reprocessing protocols
  • Hospital negligence
  • Fraudulent concealment of contamination data
  • Negligent failure to recall or field-correct

Damages What You Can Recover

  • Medical bills (past and future)
  • Lost wages and reduced earning capacity
  • Long-term disability compensation
  • Pain and suffering
  • Emotional distress
  • Wrongful death damages

What Patients and Families Ask Us Most

My hospital doesn't use one of the three named manufacturers — do I still qualify?

These three manufacturers make up the vast majority of duodenoscopes in use, but if you're unsure which device was used in your procedure, your medical records will typically identify it. Reach out and we can help confirm.

What does it cost to work with Cornerstone Law?

We handle endoscopy infection cases on contingency — no upfront fee, and we only get paid if we recover compensation for you.

Is there a class action or MDL for this yet?

Not formally yet. Cases are coordinating through a California case management order while the JPML considers whether to centralize filings nationwide into a formal MDL.

My family member passed away after this kind of infection — can we still file?

Yes. Surviving family members may be able to bring a wrongful death claim on the decedent's behalf. We can walk you through what that looks like in your state.

Why Cornerstone Law: We track every FDA alert, discovery order, and MDL development, pursuing claims against manufacturers and hospitals alike to ensure our clients receive the strongest possible representation.

Cornerstone Law Is Reviewing Endoscopy Infection Cases Nationwide

We represent patients harmed by contaminated endoscopes and duodenoscopes. Find out whether your infection and procedure history qualify for a claim.

Get a Free Case Review

No fee unless we recover compensation for you. Call 1-800-928-9445.

This page is for informational purposes only and does not constitute legal advice. Prior results do not guarantee a similar outcome in any future case. This is a paid legal advertisement from Cornerstone Law, LLP. Attorney Frank Zeccola, Esq., licensed to practice law in California, is responsible for this advertisement.
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