Reusable medical scopes used in endoscopy, ERCP, bronchoscopy and ureteroscopy have been linked to serious infections when bacteria survive cleaning between patients. If you developed a severe infection after one of these procedures, a free case review can tell you whether you may have a claim against the device maker.
Where This Stands Right Now
This is an active investigation, not a settlement. There is no fund, no class, no claim form and no deadline to miss, and nothing on this page is a promise of payment. What exists is a body of federal safety findings, regulatory action and filed litigation concerning reusable medical scopes and the infections that followed procedures performed with them.Attorneys are currently reviewing claims from patients who developed a serious infection after a scope procedure. A review is free, takes about a minute to start, and carries no obligation. If your situation does not fit, you will be told that.
Allegations Only — Nothing Here Has Been Proven
Who May Qualify
Attorneys reviewing these claims are generally looking for a combination of the following. You do not need every item.- A procedure performed with a reusable scope — most commonly ERCP, which uses a duodenoscope, but also upper endoscopy, colonoscopy, bronchoscopy, ureteroscopy, cystoscopy, hysteroscopy, or nasal and sinus endoscopy.
- A serious infection that followed the procedure — one that required intravenous antibiotics, an emergency visit, hospital admission, or extended follow-up care. Sepsis or bacteremia, severe pneumonia or another serious pulmonary infection, and any culture-confirmed drug-resistant organism are the patterns most often reviewed.
- A drug-resistant or unusual organism on culture — carbapenem-resistant Enterobacteriaceae, MRSA, Pseudomonas, Klebsiella and E. coli come up repeatedly in the reported outbreaks.
- A transmissible infection diagnosed within about a year of the procedure — including tuberculosis or HIV, where cross-contamination is alleged and no other source is identified.
- Notice from the facility — a letter or call telling you that you may have been exposed through an improperly reprocessed instrument, or being identified as part of a known outbreak.
- Timing — procedures from 2015 onward are the current focus, since that is when the reprocessing failures became widely documented. Earlier procedures are not automatically excluded, but they raise deadline questions worth reviewing.
- A death in the family — if a relative died from an infection that followed a scope procedure, a wrongful death or survival claim may be available to the spouse, children, parents or the estate.
Why the Device Design Is the Issue
The claims are not really about sloppy cleaning at a particular hospital. They are about whether certain instruments could be cleaned reliably at all.A duodenoscope, the instrument used in ERCP, carries a movable component at its tip called an elevator, which steers instruments into the bile and pancreatic ducts. That mechanism sits in a recessed area with hinges and crevices. Lawsuits allege that the design allowed body fluids and bacteria to collect in spaces that standard brushing and high-level disinfection could not reach, so that an instrument could be cleaned exactly according to the manufacturer's instructions and still carry live organisms into the next patient. Bronchoscopes and ureteroscopes raise a related problem: long, narrow internal channels that are difficult to inspect and to verify as clean.
That distinction matters for a claim. If an instrument cannot be reliably disinfected even when the instructions are followed, the theory runs against the manufacturer rather than the hospital staff.
What the Public Record Shows
A handful of documented events explain why this litigation exists. These are matters of public record, stated here as findings and filings rather than as conclusions about any individual case.- 2015 outbreak investigations. Clusters of drug-resistant infections tied to duodenoscopes at U.S. hospitals — including UCLA's Ronald Reagan Medical Center and Virginia Mason Medical Center in Seattle — drew national attention and congressional scrutiny, and prompted FDA safety communications about the devices.
- A 2017 jury verdict. A Washington state jury returned a verdict against Olympus in a wrongful death case arising from the Virginia Mason outbreak. The jury also allocated a share of fault to the hospital, which reduced the award. It remains the principal tried verdict in this litigation.
- A 2018 guilty plea. In December 2018 Olympus Medical Systems Corporation pleaded guilty in federal court in New Jersey to distributing misbranded devices, and was ordered to pay $85 million — an $80 million fine plus $5 million forfeited. The Justice Department said the company failed to file required adverse event reports about infections associated with a duodenoscope model. A former executive also pleaded guilty.
- FDA postmarket surveillance. The FDA ordered duodenoscope manufacturers to sample and culture reprocessed devices in real clinical use. Preliminary results were far worse than the agency had projected: up to 5.4% of properly collected samples grew organisms the FDA classifies as high concern, against an expected rate under 0.4%. The agency subsequently pressed the field toward disposable and disposable-component designs.
Devices and Manufacturers Named in Litigation
The reusable scope market is concentrated among a small number of manufacturers, and the same names recur in the filings and in the FDA's orders. Naming a company here reflects that it has been named in litigation or subject to regulatory action; it is not a statement that it caused any particular infection.- Duodenoscopes used in ERCP — the most heavily litigated category, and the devices at the center of the FDA's postmarket surveillance order, which covered Olympus, Fujifilm and Pentax.
- Bronchoscopes — used in airway and lung procedures, and linked in published reports to outbreaks in intensive care and pulmonology settings.
- Ureteroscopes — used in kidney stone and urinary tract procedures, where reusable models have been associated with infections in reported clusters.
- Other flexible endoscopes — gastroscopes, colonoscopes and similar instruments share the reprocessing challenges described above, and claims involving them are reviewed on the same facts.
What Can Be Recovered
Damages in a medical device injury claim are meant to cover what the injury actually cost, which in a serious infection is often far more than the hospital bill.- Medical expenses — emergency treatment, hospital and intensive care admissions, extended or last-resort antibiotic therapy for resistant organisms, and any surgery required to treat complications.
- Future care — where the infection caused lasting organ damage or ongoing treatment needs.
- Lost income — wages lost during treatment and recovery, and reduced earning capacity where the injury is permanent.
- Pain, suffering and emotional distress.
- Wrongful death damages — for a spouse, children, parents or estate where the patient died.
- Punitive damages — available in some states, and typically argued where a plaintiff can show a manufacturer knew of a risk and did not disclose it.
Amounts vary enormously with the severity of the injury, the strength of the causation evidence and the law of the state where the claim is brought. Nothing above is a prediction about any individual case, and prior results do not guarantee a similar outcome.
How Long Do You Have to File?
Every one of these claims has a deadline, and in some states it is short.- State statutes of limitations control. For product liability and personal injury claims the periods commonly run two to four years, and some states are shorter.
- The discovery rule often matters more than the procedure date. In many states the clock starts when you knew, or reasonably should have known, that your injury was connected to the device — not on the day of the procedure. Patients who only recently learned of a possible scope link may still be inside the window.
- Wrongful death deadlines run separately, usually from the date of death, and are frequently shorter than the injury deadline would have been.
- Statutes of repose in some states cut off claims a fixed number of years after the device was sold, regardless of when the injury was discovered.
Because the discovery question is fact-specific, the practical answer is that only a review of your actual dates and records will tell you whether a claim is still open. Assuming it is too late is how otherwise valid claims are lost.
What Happens After You Submit
- You answer a few questions about the procedure, the infection and roughly when it happened. It takes about a minute.
- Your answers are screened against the criteria attorneys are currently accepting for these claims.
- If you may qualify, an attorney contacts you for a free consultation and, with your permission, requests the medical records needed to evaluate causation.
- You decide. There is no obligation at any stage, and you are never required to hire anyone you speak with.
Investigation Disclaimer
This is a legal advertisement. Attorney advertising disclaimer: the information on this page is not, and is not intended to be, legal advice. You should consult an attorney about your individual situation. Contacting us does not create an attorney-client relationship. Prior results do not guarantee a similar outcome. No class action settlement has been reached in this matter and there is no claim form to file. Submitting your information does not guarantee that you will receive compensation and does not mean a lawsuit will be filed on your behalf. OpenClassActions.com is a consumer advocacy and class action news site, and is not a class action administrator or a law firm.Frequently Asked Questions
What is a medical scope infection lawsuit?
It is a product liability claim brought by a patient who developed a serious infection after a procedure performed with a reusable medical scope. The claims generally allege that the device was designed in a way that made reliable disinfection between patients difficult, and that the manufacturer did not adequately warn hospitals of that risk. These are allegations. Liability is decided case by case, and several manufacturers dispute the claims.
Which procedures and devices are involved?
The most heavily litigated device is the duodenoscope used in ERCP, a procedure on the bile and pancreatic ducts. Claims have also involved bronchoscopes used in airway procedures, ureteroscopes used for kidney stones and urinary tract work, and other flexible endoscopes including gastroscopes and colonoscopes. The common factor is a reusable instrument with narrow internal channels or a moving tip mechanism that is hard to clean.
How would I know my infection came from a scope?
Common indicators are a serious bacterial infection that appears within days or weeks of a scope procedure with no other clear source, a drug-resistant organism identified on culture, or a notification letter from the hospital about a possible exposure. Your medical records, the culture results and the facility's infection-control reporting are what an attorney would review to evaluate the connection.
My procedure was several years ago. Is it too late?
Not necessarily. Deadlines are set by state law and commonly run from the date you knew, or reasonably should have known, that your injury was connected to the device rather than from the procedure date itself. Because that discovery question is fact-specific and the periods are short in some states, it is worth having the dates reviewed rather than assuming the window has closed.
What does it cost to have a claim reviewed?
Nothing. Case reviews are free, and attorneys handling medical device injury claims generally work on a contingency fee, meaning they are paid a percentage of any recovery and nothing if there is no recovery. You are never obligated to hire anyone.
Can a family member file if the patient died?
In most states a surviving spouse, child, parent or the representative of the estate can bring a wrongful death or survival claim. The deadlines for those claims often differ from the deadline that would have applied to the patient, which is another reason to have the specific dates reviewed early.
Sources
• U.S. Department of Justice, District of New Jersey — Olympus Medical Systems Corporation guilty plea and $85 million penalty (December 2018).
• U.S. Food and Drug Administration — duodenoscope safety communications, postmarket surveillance (522) order and interim sampling and culturing results.
• Court records in the Washington state wrongful death action arising from the Virginia Mason Medical Center outbreak.
• Published hospital outbreak investigations and FDA adverse event reporting concerning reprocessed flexible endoscopes.
