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ERCP and Duodenoscope Infection Lawsuits

A jury handed down a $6.6 million verdict in the first lawsuit against duodenoscope makers. Hundreds more potential lawsuits may be filed over the devices after the scopes spread “superbug” infections that killed 35 people and sickened hundreds more at more than 40 different hospitals.

Suffer from a "superbug" infection after an ERCP duodenoscope procedure?

If you developed a bacterial infection or other side effects after an ERCP duodenoscope procedure, you may be eligible for compensation.

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Duodenoscopes are used during a potentially life-saving procedure to diagnose and treat conditions of the pancreas and bile duct. The procedure is called ERCP, which stands for endoscopic retrograde cholangiopancreatography.

These long, flexible tubes are snaked down a patient’s throat, through the stomach and into the small intestine. Their tips contain cameras and can be fitted with different medical instruments to carry out different procedures.


The design of recent duodenoscope models left small nooks and crannies in the tip, creating hiding places for bacteria and making the devices difficult to sterilize between uses. The U.S. Food and Drug Administration determined that dangerous bacteria could survive in these crevices even if hospitals followed cleaning instructions from the devices’ makers.

The Centers for Disease Control and Prevention (CDC) associated this design flaw with several outbreaks of so-called “superbug” infections between 2010 and 2015.

Superbug infections are caused by antibiotic-resistant bacteria:
Methicillin-resistant Staphylococcus aureus
Carbapenem-resistant Enterobacteriaceae
C. diff
Clostridium difficile
Vancomycin-resistant Enterococcus
Extended Spectrum Beta-Lactamases
Multidrug-resistant Pseudomonas aeruginosa
Multidrug-resistant Acinetobacter

People who were infected, or relatives of people who died from these infections have been filing lawsuits claiming duodenoscopes are responsible for their injuries.

Status of Duodenoscope Infection Lawsuits

There were at least nine lawsuits filed, underway or resolved by mid-2017.

Duodenoscope Fact
The First Duodenoscope Verdict Was $6.6 Million

Duodenoscope lawsuits remain in the early stages and attorneys are still weighing the potential for individual lawsuits. But they think hundreds of people could qualify to file lawsuits against duodenoscope manufacturers.

Did you contract a superbug infection from an ERCP duodenoscope procedure? Get A Free Case Review

Why People Sue Over Duodenoscope Complications

People who underwent an endoscopic procedure between 2010 and 2015 and later developed an infection requiring additional hospitalization have been filing lawsuits against duodenoscope makers.

People suing over duodenoscope-related infections claim:
  • They suffered from superbug infections due to contaminated reprocessed (reused) duodenoscopes
  • They were hospitalized as a result of the infection
  • Relatives died as a result of infection from a reprocessed duodenoscope

Accusations in Lawsuits Against Duodenoscope Manufacturers

People who filed lawsuits claim the companies made and marketed an unsafe product

People who have filed lawsuits against duodenoscope manufacturers claim that the companies made and marketed an unsafe product. They claim that the manufacturers knew or should have known that their devices were unsafe but failed to warn doctors and patients of the risks.

The Los Angeles Times reported on company emails between Olympus executives indicating they knew of problems disinfecting the devices in 2013. But the company told its U.S. executives that there was no need to warn hospitals or doctors of the risk even as the number of outbreaks was increasing.

Duodenoscope Manufacturers and Brands Named in Lawsuits

At least three device manufacturers face potential lawsuits in the wake of the infection outbreaks.

Olympus produced more than 8 in 10 of the duodenoscopes in service across the U.S. when the outbreaks occurred, and has been the focus of most lawsuits and government scrutiny. But other manufacturers potentially face lawsuits over the outbreaks as well.

Duodenoscope Manufacturers
Olympus Logo


Pentax Logo


fujifilm logo


Settlements and Verdicts in Duodenoscope, Infection Lawsuits

Duodenoscope lawsuits are in the very early stages, but there have already been jury verdicts and at least one settlement totaling close to $7 million.

Early Duodenoscope Verdicts and Settlements
  • June 2017
    Olympus settles an individual lawsuit over its devices for an undisclosed amount
  • July 2017
    Jury awards $6.6 million to Virginia Mason Medical Center after the hospital sued duodenoscope-maker Olympus following a superbug outbreak
  • July 2017
    Jury tells hospital to pay $1 million to Theresa Bigler, the widow of a patient who died after becoming infected
  • January 2018
    Judge orders new trial for Theresa Bigler’s personal lawsuit against Olympus after emails reveal the company may have known about design issues earlier than disclosed

In February 2016, Olympus also paid $612 million to settle claims it violated federal law to sell and market its duodenoscopes through an illegal kickback scheme

Duodenoscope Infection Class-Action Lawsuits

There are currently no class-action lawsuits against duodenoscope makers. As more individual lawsuits are filed, lawyers may seek another form of mass legal action such as a multidistrict litigation (MDL). MDLs allow the combination of multiple cases with similar injuries and facts to cut expenses and move lawsuits through the legal process more quickly.

Studies, Recalls and Government Actions

The Centers for Disease Control and Prevention alerted the FDA to the connection between infection outbreaks and duodenoscopes in 2013. The FDA spent another two years collecting information and investigating the connection before any of the devices were recalled.

During this time, infections continued to spread, people continued to suffer infections, and some died.

“If [the] FDA had acted earlier, there would be fewer unnecessary deaths.”

U.S. Representative Ted Lieu (D-Calif.) quoted in the Los Angeles Times, March 3, 2015

The CDC, FDA, U.S. Department of Justice and the Congress all conducted separate investigations into how duodenoscopes spread superbug infections during ERCP procedures.

Scope of Duodenoscope Infection Outbreaks, 2010 – 2015
Hospitals Affected 41
People Infected 300-404
Deaths 35 or more
Procedures Performed 500,000 per year

The FDA came under criticism for not discovering the problem sooner. The agency turned over reports showing that as many as 448 people may have been infected or exposed to superbugs through duodenoscope procedures. But the agency said it may have received multiple reports of the same incident and could not determine exactly how many people had actually been affected.

  • 2010
    Earliest infections appear
  • 2010
    Centers for Disease Control and Prevention alerts FDA to potential “superbug” contamination on duodenoscopes
  • March 2014
    FDA alerts Olympus to design issues that may hamper cleaning
  • February 2015
    FDA safety communication warns manufacturer-recommended cleaning procedures for duodenoscopes may not be adequate
  • May 2015
    U.S. Department of Justice opens investigation into Olympus’ duodenoscope marketing and sales practices
  • August 2015
    FDA issues warning letters about duodenoscope cleaning problems to device manufacturers Olympus, Pentax and Fujifilm
  • January 2016
    Olympus recalls original model of its duodenoscopes
  • January 2016
    FDA approves design changes for Olympus duodenoscopes
  • January 2016
    U.S. Senate report finds widespread infections resulting from contaminated duodenoscopes during a five-year period
  • February 2016
    Olympus pays the federal government $612 million plus interest to settle criminal charges relating to allegations of paying kickbacks to doctors and medical facilities to use its duodenoscopes
  • February 2016
    U.S. House committee releases FDA document saying that as many as 404 people may have been infected by contaminated duodenoscopes
  • January 2017
    Fujifilm removes certain older model duodenoscopes from the market
  • September 2017
    FDA approves Pentax duodenoscope with a disposable cap
  • February 2018
    Pentax recalls all ED-3490TK duodenoscopes. Company updates Operations Manual for annual maintenance. Pentax replaces forceps elevator mechanism, O-ring seal and distal end cap in all recalled scopes.

Please seek the advice of a medical professional before making health care decisions.

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40 Cited Research Articles

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  20. Jeffery John Hughes and Annie Ruth Hughes v. Olympus America, Inc., et al. (2015). Complaint For: (1) Products Liability; (2) Negligence; (3) Fraud – Intentional Misrepresentation; (4) Fraud – Negligent Misrepresentation; (5) Survival Action; (6) Wrongful Death. Retrieved from
  21. Leo Palomino v. Olympus America, Inc., et al. (2015, June 1). Order Granting Plaintiffs’ Motions To Remand. Retrieved from
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  23. Reuters. (2015, May 13). Seattle hospital joins ‘superbug’ lawsuit against scope manufacturer. Retrieved from
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  26. Terhune, C. and Petersen, M. (2015, May 28). Justice Department investigates scope maker Olympus over superbug outbreaks. Retrieved from
  27. Terhune, C. (2015, March 3). FDA says firms have twice failed to show scopes can be rid of superbugs. Retrieved from
  28. Terhune, C. (2015, March 4). Superbug outbreak extends to Cedars-Sinai hospital, linked to scope. Retrieved from
  29. Terhune, C. (2015, February 26). UCLA outbreak: Family of 48-year-old who died sues scope maker. Retrieved from
  30. Terhune, C. (2015, March 17). New lawsuits filed against scope maker in deadly UCLA superbug outbreak. Retrieved from
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  33. U.S. Department of Justice. (2016). Deferred Prosecution Agreement. Retrieved from
  34. Eisler, P. (2015, August 5). Deadly Infections from Medical Scopes Go Unreported, Raising Health Risks. Retrieved from
  35. Business Wire. (2015, November 20). Lieff Capraser Announces Filing of Wrongful Death and Product Liability Lawsuit Against Olympus and Custom Ultrasonics for Fatal Superbug Infection of Willie Warner, Jr. from Contaminated Medical Scope. Retrieved from
  36. Terhune, C. and Petersen, M. (2015, December 19). How a Medical Device Maker Kept U.S. Hospitals in the Dark About Deadly Infections. Retrieved from
  37. U.S. District Court, Western District of North Carolina. (2017, June 5). Joint Motion and Stipulation for Voluntary Dismissal with Prejudice; Warner v. Olympus America, Inc., et al. Retrieved from
  38. Terhune, C. and Aleccia, J. (2017, July 25). Jury Orders Olympus to pay $6.6 Million but Rejects Claims Its Medical Scopes Are Unsafe. Retrieved from
  39. Terhune, C. (2018, January 18). Judge Orders New Olympus Trial Over Superbug Death. Kaiser Health News. Retrieved from
  40. U.S. Food and Drug Administration. (2018, February 7). Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication – Updated Design and Labeling Cleared. Retrieved from
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