- 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.
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 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.
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
Olympus settles an individual lawsuit over its devices for an undisclosed amount
Jury awards $6.6 million to Virginia Mason Medical Center after the hospital sued duodenoscope-maker Olympus following a superbug outbreak
Jury tells hospital to pay $1 million to Theresa Bigler, the widow of a patient who died after becoming infected
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 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
||35 or more
||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
Earliest infections appear
Centers for Disease Control and Prevention alerts FDA to potential “superbug” contamination on duodenoscopes
FDA alerts Olympus to design issues that may hamper cleaning
FDA safety communication warns manufacturer-recommended cleaning procedures for duodenoscopes may not be adequate
U.S. Department of Justice opens investigation into Olympus’ duodenoscope marketing and sales practices
FDA issues warning letters about duodenoscope cleaning problems to device manufacturers Olympus, Pentax and Fujifilm
Olympus recalls original model of its duodenoscopes
FDA approves design changes for Olympus duodenoscopes
U.S. Senate report finds widespread infections resulting from contaminated duodenoscopes during a five-year period
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
U.S. House committee releases FDA document saying as many as 404 people may have been infected by contaminated duodenoscopes
Fujifilm removes certain older model duodenoscopes from the market
FDA approves Pentax duodenoscope with a disposable cap
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.
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.
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