Duodenoscope Lawsuits

Duodenoscope lawsuits against Olympus and other scope makers claim the devices spread “superbug” infections that killed 35 people and sickened hundreds of others at more than 40 different hospitals worldwide. A jury handed up a $6.6 million verdict in the first trial against duodenoscope makers in 2017.

duodenoscope
Duodenoscope Lawsuit Facts
  1. Injuries Antibiotic-resistant infection, death
  2. Manufacturers Olympus, Pentax, Fujifilm
  3. Top Verdict $6.6 million

People began filing duodenoscope lawsuits after several United States hospitals experienced infection outbreaks starting in 2010. The infections often included antibiotic-resistant bacteria. The most notable was carbapenem-resistant Enterobacteriae, or CRE, which is a deadly superbug that has a 50 percent risk of death.

From January 2010 to October 2015, more than 400 patients were infected, dozens more were exposed and several people who had been infected died, according to an investigation by The United States Senate Health, Education, Labor, and Pensions Committee (HELP).

At least 36 hospitals around the United States experienced superbug outbreaks between 2010 and 2015. These hospitals reported CRE infections linked to duodenoscopes that had been used during a procedure called endoscopic retrograde cholangiopancreatography, or ERCP. The procedure allows doctors to diagnose and treat diseases that affect the bile and pancreatic ducts.

The most publicized outbreak occurred in the Ronald Reagan UCLA Medical Center in 2015, and this led to several lawsuits against Olympus Medical Systems Group, according to the American Bar Association.

Manufacturer Olympus sells about 85 percent of duodenoscopes in the United States, according to Kaiser Health News. It has been the focus of most lawsuits and government scrutiny. Pentax and Fujifilm also face lawsuits.

According to the Centers for Disease Control and Prevention, superbug infections caused by antibiotic-resistant bacteria include:
  • 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

The first lawsuits over duodenoscope and ERCP-related infections went to trial in 2017. So far, Olympus has settled a couple lawsuits for confidential amounts and has faced a multi-million dollar jury verdict.

In November 2018, The Japan Times reported Olympus faced at least 50 duodenoscope lawsuits in multiple courts. The lawsuits were seeking compensation for superbug infections. In its 2018 Integrated Report, Olympus did not disclose the exact number of pending lawsuits.

“As these lawsuits are still before the courts, Olympus will refrain from commenting on this matter,” the company said in a Nov. 22, 2018 news release.

Duodenoscope Infection Outbreaks, 2010 – 2015
United States Hospitals Affected 30
People Infected As many as 404
Deaths 35 or more
Procedures Performed in the United States More than 500,000 per year
Sources: U.S. Senate Health, Education, Labor and Pensions Committee, Jan. 13, 2016, U.S. House Committee on Oversight and Government Reform, Feb. 15, 2016, and U.S. Food and Drug Administration, Dec. 10, 2018

Defective Design and Negligence

Lawsuits say the design of duodenoscope models leaves small nooks and crannies in the tip. The Centers for Disease Control and Prevention and the Food and Drug Administration determined this design feature created hiding places for bacteria. It also made the devices difficult to sterilize between procedures.

Federal investigators determined the design flaw allowed bacteria to survive even when hospital staff followed manufacturers’ cleaning instructions.

“[Olympus] knew, or should have known, that if these residual fluids [in duodenoscopes] contain microbial contamination, multiple patients would be exposed to a serious risk of harm, including lethal infection.”

Source: The Estate of Antonia Cerda et al. v. Olympus America, Inc. et al., Case No. BC573665

Lawsuits allege duodenoscope manufacturers knew their products were faulty but they failed to warn the public or provide adequate cleaning instructions to protect people from infection. Furthermore, plaintiffs say Olympus did not tell hospitals that its cleaning protocol did not eliminate all organic material or body fluids left on the scope. This remaining organic debris could harbor infection.

In October 2014, Antonia Torres Cerda underwent multiple procedures with Olympus’ contaminated Q180V Scope at Ronald Reagan UCLA Medical Center, according to a lawsuit filed by Armando Cerda and his family against Olympus America Inc. in the Superior Court of California, County of Los Angeles. Antonia contracted an infection and died. The family sued Olympus and its sales representatives.

“Defendant knew, or should have known, that if these residual fluids contain microbial contamination, multiple patients would be exposed to a serious risk of harm, including lethal infection,” the lawsuit said. “Defendant’s reprocessing instructions did not prepare the Q180V Scope for safe re-use.”

In addition to the Cerda family, dozens have filed lawsuits, including Debbie Newton and the children of Renate Winkler.

Debbie Newton

Washington resident Debbie Newton filed a lawsuit against Olympus after she underwent an ERCP procedure for gallstones in February 2013. Following the procedure, doctors placed her on life support for heart, respiratory and renal failure. She also suffered pancreatitis, septic shock and bacteremia. She tested positive for several serious infections, including klebsiella, e-coli and enterococcus bacterial infection. Doctors gave her intravenous antibiotics meant to fight CRE.

In addition to negligence, Newton’s lawsuit alleges Olympus redesigned its Q180V Scope and sold it without FDA approval or clearance to do so. The redesign caused a “wicking effect” where the scope dragged biologic material (including CRE bacteria) behind the “sealed elevator wire,” a part of the device that cannot be adequately reached through cleaning.

Newton suffered CRE infection, septic infection, multiple organ failure, diverticulitis, colon infection, depression and other injuries.

Renate Winkler

Renate Winkler, an 82-year-old Illinois resident, underwent a procedure with a duodenoscope and died after contracting CRE. Her children, Ronald Winkler and Iris Tripicchio, filed a lawsuit against Pentax and the hospital. According to the lawsuit, the duodenoscope was defective because its design prevented proper cleaning.

“As a medical device manufacturer, Pentax has an obligation to develop, test and validate the safety of its products prior to selling them,” attorney Lexi Hazam told the Chicago Tribune.

“As a medical device manufacturer, Pentax has an obligation to develop, test and validate the safety of its products prior to selling them.”

Source: Attorney Lexi Hazam told the Chicago Tribune

Undisclosed Settlements, $6.6 Million Verdict

In December 2018, Olympus settled lawsuits from two widows whose husbands were among 18 people who died from superbug infections following duodenoscope procedures at Seattle’s Virginia Mason Medical Center.

The settlement amounts paid to Deborah Shawver and Theresa Bigler were not disclosed. Shawver’s lawsuit had been scheduled for trial in late 2019.
Bigler had previously sued Olympus, and the Virginia Mason Medical Center joined her lawsuit.

In July 2017, following an eight-week trial, a Washington state jury ordered Olympus to pay the hospital $6.6 million in damages over the superbug outbreak. But the jury decided that the medical center shared in the blame for Richard Bigler’s death. It ordered the hospital to turn over $1 million of the verdict to Theresa Bigler.

Olympus had previously reached at least one other undisclosed settlement in a lawsuit over its scopes.

Carla Warner of North Carolina sued Olympus after her husband, Bill, died in 2013 from an infection following a duodenoscope procedure. Warner says her husband had suffered severe pain and had lost 60 pounds over eight months before he died. He was forced to rely on a feeding tube, and because of the danger of spreading the infection, he was forced to spend much of his time isolated from friends and family.

Olympus agreed to settle with Warner for an undisclosed amount in June 2017 — about one month before the case was set for trial in a North Carolina federal court.

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

Olympus Warned European But Not United States Hospitals

Senate staff investigators found that by early 2013, Olympus had knowledge of two independent lab reports that showed the potential of certain scope models to harbor and spread bacteria even after proper cleaning procedures. The manufacturer didn’t inform the FDA, hospitals, physicians or patients about the risk of infection until February 2015.

Senate staff investigators found Olympus had knowledge of two independent lab reports that showed the duodenoscopes could harbor and spread bacteria even after appropriate cleaning.
Source: U.S. Senate Health, Education, Labor and Pensions Committee, Jan. 13, 2016

Senate investigators found Olympus had sent out an “Important Safety Advice” notice to European hospitals in 2013 in response to a “reported case of a contaminated Olympus Video-Duodenoscope TJFQ180V.” Olympus had sent out a second alert to European hospitals in August 2014. The field safety notice addressed “prevention of cross infection among patients.”

But the Senate report said Olympus did not alert American hospitals until after a February 2015 outbreak at UCLA and Cedars-Sinai medical centers in California. Seven patients were sickened and two died in the outbreak. By the time the Olympus warning finally reached American health care providers, the Senate investigators estimated about 200 more patients may have also been infected at UCLA, and many more could have been infected in hospitals across the country.

Later, the committee learned that an outbreak in October 2014 in Seattle was linked to the same model scope. This outbreak also occurred after Olympus’ European warnings.

The delay in reporting led the United States Justice Department and the FDA to pursue criminal charges.

In December 2018, Olympus and one of its former executives pleaded guilty to federal charges that they failed to file adverse event reports linking the company’s scopes to the European outbreaks. Olympus agreed to pay $85 million in fines and other penalties in a plea bargain with the Justice Department. Hisao Yabe, the company’s executive in charge of complying with United States reporting laws, faces up to a year in prison and a $100,000 fine at his March 2019 sentencing.

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

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
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  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By
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49 Cited Research Articles

  1. 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/
  2. 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/
  3. 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/
  4. Bell, K. (2015, June 4). Pentax, FujiFilm receive US Department of Justice subpoenas over duodenoscopes: report. Retrieved from http://www.firstwordmedtech.com/node/977056
  5. Bell, K. (2015, March 29). Olympus receives US Department of Justice subpoena over duodenoscopes. Retrieved from http://www.firstwordmedtech.com/node/976866
  6. Blethen, R. (2018, December 13). Two Seattle-Area Women Settle Wrongful-Death “Superbug” Lawsuits with Medical Scope Manufacturer. Seattle Times. Retrieved from https://www.seattletimes.com/seattle-news/health/two-seattle-area-women-settle-wrongful-death-superbug-lawsuits-with-medical-scope-manufacturer/
  7. 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
  8. 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/
  9. 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/
  10. 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/
  11. Davis, J. (2017, March 2). Contaminated Medical Devices — Duodenoscope Litigation and Beyond. Retrieved from https://www.americanbar.org/groups/litigation/committees/products-liability/practice/2017/contaminated-medical-devices-duodenoscope-litigation-and-beyond/
  12. 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?
  13. 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/
  14. 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
  15. Johnson, J. (2015, September 4). Family members of woman who died sue Park Ridge hospital. Retrieved from https://www.chicagotribune.com/suburbs/park-ridge/news/ct-prh-advocate-lawsuit-tl-0910-20150904-story.html
  16. Kaiser Health News. (2016). FDA Document Suggests Higher Number of Duodenoscope Incidents Than Previously Reported. Retrieved from https://kaiserhealthnews.files.wordpress.com/2016/04/house-scope-report.pdf
  17. Kyodo. (2018, November 26). Over 190 superbug infections reported in U.S. and Europe after using Olympus endoscopes, probe finds. Retrieved from https://www.japantimes.co.jp/news/2018/11/26/national/190-superbug-infections-reported-u-s-europe-use-olympus-endoscopes-probe-finds/#.XGbBNehKiUl
  18. 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/
  19. 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
  20. Newton v. Olympus America, Inc. et al. (2015, March 19). Complaint. Retrieved from https://www.courts.phila.gov/common-pleas/
  21. Olympus. (2018). Integrated Report. Retrieved from https://www.olympus-global.com/ir/data/integratedreport/pdf/integrated_report_2018e_A3.pdf
  22. Olympus. (2018, November 22). Olympus Issues Summary Statement Regarding News Reports about the Company and Certain Subsidiaries. Retrieved from https://www.olympus-global.com/news/2018/contents/nr01001/nr01001_00000.pdf
  23. Raymond, N. (2018, December 10). Olympus unit pleads guilty to resolve U.S. duodenoscope probe. Retrieved from https://www.reuters.com/article/us-olympus-usa/olympus-unit-pleads-guilty-to-resolve-u-s-duodenoscope-probe-idUSKBN1O92DJ
  24. 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
  25. Schencker, L. (2015, May 18). Virginia Mason joins widow in suing device maker over contaminated scopes. Retrieved from http://www.modernhealthcare.com/article/20150518/NEWS/150519895
  26. Terhune, C. & Aleccia, J. (2017, July, 25). Scope Maker Olympus Hit with $6.6 Million Verdict in Superbug Outbreak Case. Retrieved from https://khn.org/news/scope-maker-olympus-hit-with-6-6-million-verdict-in-superbug-outbreak-case/
  27. 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
  28. Terhune, C. (2015, March 17). New lawsuits filed against scope maker in deadly UCLA superbug outbreak. Retrieved from https://www.latimes.com/business/la-fi-ucla-superbug-patients-20150317-story.html
  29. 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
  30. 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
  31. 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/
  32. Terhune, C. (2018, January 18). Judge Orders New Olympus Trial Over Superbug Death. Retrieved from https://khn.org/news/olympus-faces-new-trial-over-medical-scopes-tied-to-superbug-deaths/
  33. 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
  34. 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
  35. 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/
  36. 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
  37. The Estate of Antonia Cerda et al. v. Olympus America, Inc. et al. (2015, March 27). Complaint. Retrieved from https://www.pacermonitor.com/public/case/7877866/The_Estate_of_Antonia_Cerda_et_al_v_Olympus_America_Inc_et_al
  38. U.S. Centers for Disease Control and Prevention. (2016, March 3). Superbugs Threaten Hospital Patients. Retrieved from https://www.cdc.gov/media/releases/2016/p0303-superbugs.html
  39. U.S. Department of Justice. (2016). Deferred Prosecution Agreement. Retrieved from https://www.justice.gov/usao-nj/file/867021/download
  40. 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/
  41. U.S. Food and Drug Administration. (2014, March 18). Letter to Olympus Medical Systems; Document Number CPT1400142. Retrieved from https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM436587.pdf
  42. U.S. Food and Drug Administration. (2015, March 4). Updated Information for Healthcare Providers Regarding Duodenoscopes. Retrieved from https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/UCM436588.pdf
  43. U.S. Food and Drug Administration. (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
  44. U.S. Food and Drug Administration. (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
  45. U.S. Food and Drug Administration. (2018, December 10). Infections Associated with Reprocessed Duodenoscopes. Retrieved from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/reprocessingofreusablemedicaldevices/ucm454630.htm
  46. U.S. Food and Drug Administration. (2017, September 20). FDA Clears First Duodenoscope with Disposable Distal Cap. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576753.htm
  47. 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 https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm595788.htm
  48. U.S. House Committee on Oversight and Government Reform. (2016, February 15). FDA Suggests Higher Number of Duodenoscope Incidents than Previously Reported. Rep. Ted Lieu. Retrieved from https://lieu.house.gov/sites/lieu.house.gov/files/OGR%20Briefing%20Memos.pdf
  49. U.S. Senate Health, Education, Labor and Pensions Committee. (2016, January 13). Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients. Retrieved from https://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf
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