Endoscope & Duodenoscope Infection Litigation:
FDA Alerts & Discovery Developments
New FDA safety alerts targeting Olympus, Pentax, and Fujifilm sparked a surge in 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. Our firm is accepting cases nationwide.
Named Defendants
Which Manufacturers & 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.
Key Case & Discovery Orders
Where the Litigation Stands Now
A major 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.
How Patients Were Harmed
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 cannot be fully cleaned — a design flaw plaintiffs allege manufacturers knew about for years.
Impossible to Sterilize
The device’s architecture 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 information to hospitals, physicians, or the FDA in a timely manner.
Hospital Reprocessing Failures
Several hospitals are named as co-defendants for failing to follow FDA-required reprocessing protocols, allowing contaminated scopes to 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 & Recall
Despite accumulating evidence of infection risk, manufacturers delayed issuing adequate warnings and field corrections, prolonging patient exposure to known contamination hazards.
Eligibility
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 who received a confirmed drug-resistant diagnosis and those hospitalized for 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
Legal Theories & Damages
Liability & 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
Our Firm Is Now Accepting Endoscopy Infection Cases
We represent patients nationwide harmed by contaminated endoscopes and duodenoscopes. 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 and maximum recovery.
We handle these cases on a contingency fee basis — you pay nothing unless we win.