Accepting Cases

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.

*Please seek the advice of a medical professional before discontinuing the use of this medical device.

If you caught one of the following after an ERCP duodenoscope procedure, you may be entitled to compensation.

  • Superbug infection CRE
  • other dangerous bacteria
Are you suffering complications from an ERCP duodenoscope procedure?

Number of Lawsuits Unknown; lawsuits are relatively new

Plaintiff Injuries Superbug infections due to contaminated reprocessed (reused) duodenoscopes; some resulting in death

Defendants Ethicon, Olympus America, Inc. and Olympus Corp.

Class-Action Status No class action lawsuits are pending

Litigation Status Still in the early stages

Get A Free Case Review

Written by

Senior Content Writer

Edited by

Kevin Connolly Managing Editor

This page features

11 Cited Research Articles

Fast Facts

  • A design flaw allowed duodenoscopes to spread antibiotic-resistant superbug infections.
  • Hundreds of patients examined with duodenoscopes were infected and dozens died.
  • The largest verdict so far in lawsuits over the defective devices totaled $6.6 million.

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.

Duodenoscopes are used in 500,000 medical procedures every year.

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, including:

  • MRSA – Methicillin-resistant Staphylococcus aureus
  • CRE – Carbapenem-resistant Enterobacteriaceae
  • C. diff – Clostridium difficile
  • VRE – Vancomycin-resistant Enterococcus
  • ESBL- 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.

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 the companies made and marketed an unsafe product. They claim the manufacturers knew or should have known 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 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 LogoOlympus

Pentax LogoPentax

Fujifilm LogoFujifilm

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 the widow of a patient who died after becoming infected

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 multiple cases with similar injuries and facts may be combined 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 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 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.

Timeline of Duodenoscope Infection Issues

  • 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 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

Author

Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.


{

Hide Sources

  1. Mangan, D. (2016, July 25). 35 Deaths Linked to Scope Infections After Olympus Told Execs Not to Warn Hospitals. Retrieved from https://www.cnbc.com/2016/07/25/35-deaths-linked-to-scope-infections-after-olympus-told-execs-not-to-warn-hospitals.html
  2. FDA.gov. (2014, March 18). Letter to Olympus Medical Systems; Document Number CPT1400142. Retrieved from https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM436587.pdf
  3. FDA.gov. (2016, January 15). FDA Clears Olympus TJF-Q180V Duodenoscope with Design Modifications Intended to Reduce Infection Risk. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481956.htm
  4. FDA.gov. (2017, August 23). Infections Associated with Reprocessed Duodenoscopes. Retrieved from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/reprocessingofreusablemedicaldevices/ucm454630.htm#meeting
  5. FDA.gov. (2017, September 20). FDA Clears First Duodenoscope with Disposable Distal Cap. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576753.htm
  6. Terhune, C. (2015, March 3). FDA Says Firms have Twice Failed to Show Scopes can Be Rid of Superbugs. Retrieved from http://www.latimes.com/business/la-fi-fda-superbug-scopes-20150303-story.html
  7. CDC.gov. (2016, March 3). Superbugs Threaten Hospital Patients. Retrieved from: https://www.cdc.gov/media/releases/2016/p0303-superbugs.html
  8. Aleccia, J. (2015, March 4). Widow sues Virginia Mason; hospital begins notifying ‘superbug’ victims. Retrieved from http://www.seattletimes.com/seattle-news/health/widow-sues-virginia-mason-hospital-begins-notifying-superbug-victims/
  9. Aleccia, J. (2015, June 2). Scope-maker blamed for ‘superbug’ outbreak counter-sues Virginia Mason. Retrieved from http://www.seattletimes.com/seattle-news/health/scope-maker-blamed-for-superbug-outbreak-counter-sues-virginia-mason/
  10. Associated Press. (2015, March 5). Redesigned medical scope in “superbug” cases did not get FDA clearance. Retrieved from http://www.cbsnews.com/news/redesigned-medical-scope-in-superbug-cases-did-not-get-fda-clearance/
  11. Bell, K. (2015, March 29). Olympus receives US Department of Justice subpoena over duodenoscopes. Retrieved from http://www.firstwordmedtech.com/node/976866
  12. Bell, K. (2015, June 4). Pentax, FujiFilm receive US Department of Justice subpoenas over duodenoscopes: report. Retrieved from http://www.firstwordmedtech.com/node/977056
  13. CBS Los Angeles. (2015, March 17). Third Lawsuit Filed Against Endoscope Maker In UCLA Superbug Outbreak. Retrieved from http://losangeles.cbslocal.com/2015/03/17/third-lawsuit-filed-against-endoscope-maker-in-ucla-superbug-outbreak/
  14. City News Service. (2015, June 26). Orange County woman sues medical scope maker over outbreak of superbug at UCLA Medical Center. Retrieved from http://www.ocregister.com/2015/06/26/orange-county-woman-sues-medical-scope-maker-over-outbreak-of-superbug-at-ucla-medical-center/
  15. Cohen, E. (2015, March 5). Deadly superbug-related scopes sold without FDA approval. Retrieved from http://www.cnn.com/2015/03/04/us/superbug-endoscope-no-permission/
  16. Dennis, B. (2015, March 5). Widening superbug outbreak raises questions for FDA, manufacturers. Retrieved from https://www.washingtonpost.com/national/health-science/widening-superbug-outbreak-raises-questions-for-fda-manufacturers/2015/03/05/008c981a-c2e0-11e4-ad5c-3b8ce89f1b89_story.html?
  17. FDA.gov. (2015, March 4). Updated Information for Healthcare Providers Regarding Duodenoscopes. Retrieved from https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/UCM436588.pdf
  18. FDA.gov. (2016, January 15). FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481956.htm
  19. FDA.gov. (2017, August 23). Infections associated with Reprocessed Duodenoscopes. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/ucm454630.htm
  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 https://www.pacer.gov
  21. Leo Palomino v. Olympus America, Inc., et al. (2015, June 1). Order Granting Plaintiffs’ Motions To Remand. Retrieved from http://law.justia.com/cases/federal/district-courts/california/cacdce/2:2015cv02311/614355/38/
  22. Olympus. (2015, March 5). Recent Media Coverage on the Olympus TJF-Q180V Duodenoscope. Retrieved from https://medical.olympusamerica.com/sites/us/files/pdf/CustomerLetterRegardingOlympusDuodenoscope.pdf
  23. Reuters. (2015, May 13). Seattle hospital joins ‘superbug’ lawsuit against scope manufacturer. Retrieved from http://www.foxnews.com/health/2015/05/13/seattle-hospital-joins-superbug-lawsuit-against-scope-manufacturer.html
  24. Schencker, L. (2015, May 18). Virginia Mason joins widow in suing devicemaker over contaminated scopes. Retrieved from http://www.modernhealthcare.com/article/20150518/NEWS/150519895
  25. Terhune, C. and Petersen, M. (2015, August 4). Superbug outbreaks: FDA issues more scope-cleaning guidance to hospitals. Retrieved from http://www.latimes.com/business/la-fi-fda-scope-cleaning-20150804-story.html
  26. Terhune, C. and Petersen, M. (2015, May 28). Justice Department investigates scope maker Olympus over superbug outbreaks. Retrieved from http://www.latimes.com/business/la-fi-olympus-scope-subpoena-20150528-story.html
  27. Terhune, C. (2015, March 3). FDA says firms have twice failed to show scopes can be rid of superbugs. Retrieved from http://www.latimes.com/business/la-fi-fda-superbug-scopes-20150303-story.html
  28. Terhune, C. (2015, March 4). Superbug outbreak extends to Cedars-Sinai hospital, linked to scope. Retrieved from http://www.latimes.com/business/la-fi-cedars-sinai-infections-20150304-story.html
  29. Terhune, C. (2015, February 26). UCLA outbreak: Family of 48-year-old who died sues scope maker. Retrieved from http://www.latimes.com/business/la-fi-ucla-outbreak-suit-20150226-story.html
  30. Terhune, C. (2015, March 17). New lawsuits filed against scope maker in deadly UCLA superbug outbreak. Retrieved from
  31. http://www.latimes.com/business/la-fi-ucla-superbug-patients-20150317-story.html
  32. Terhune, C. (2016, December 19). Grilled About Deadly Superbug Outbreaks, Execs At Scope Maker Olympus Take Fifth. Retrieved from http://californiahealthline.org/news/grilled-about-deadly-superbug-outbreaks-execs-at-scope-maker-olympus-take-fifth/
  33. U.S. Department of Justice. (2016). Deferred Prosecution Agreement. Retrieved from https://www.justice.gov/usao-nj/file/867021/download
  34. Eisler, P. (2015, August 5). Deadly Infections from Medical Scopes Go Unreported, Raising Health Risks. Retrieved from https://www.usatoday.com/story/news/2015/08/05/duodenoscope-infections-not-reported/29988165/
  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 http://www.businesswire.com/news/home/20151120005861/en/Lieff-Cabraser-Announces-Filing-Wrongful-Death-Product
  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 http://graphics.latimes.com/superbug-scope/
  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 https://www.pacer.gov/
  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 http://www.latimes.com/business/la-fi-olympus-verdict-20170724-story.html

Were you infected by a superbug after an ERCP duodenoscope procedure?
Free Case Review