Even though duodenoscopes are exceptional devices that assist medical experts in performing several critical procedures to patients, they can also be extremely dangerous if they’re defective. At the Consumer Alert Now, we are at the forefront of identifying and educating people worldwide on the dangers associated with faulty duodenoscopes. Additionally, we help victims injured by these devices join mass torts to claim compensation. If you’ve suffered duodenoscope-related infections or any other complication, talk to us, and we will represent you in court.
What’s a Duodenoscope?
A duodenoscope is a flexible, hollow, lighted tube that enables physicians to view the patient’s duodenum or small intestine’s surface. Doctors use these during ERCP (endoscopic retrograde cholangiopancreatography) procedure. The device helps doctors diagnose & treat severe, usually life-threatening ailments like gallstones or cancer in the bile duct or pancreas. The benefit of the ERCP process is that it’s less invasive compared to traditional surgery.
Every year, American citizens undergo over half a million ERCP procedures where duodenoscopes are used. This is as per the United States Food & Drug Administration’s (FDA) website. Various conditions treated or diagnosed by duodenoscopes are:
- Gallstones (tiny masses that develop in one’s gallbladder and may stick in their bile duct)
- Surgical complications or trauma in pancreatic or bile ducts
- Pancreatic pseudocysts (the abdominal sac filled with fluid)
- Acute pancreatitis
- Cancers or tumors of the bile duct
- Chronic pancreatitis
- Pancreatic cancers and tumors
A duodenoscope plays a critical part in diagnosing & treating ailments, and it is generally safe. However, investigations by the FDA, Senate HELP (Health, Education, Labor, & Pensions) Committee, and CDC (Centers for Disease Control & Prevention) established that the device’s design caused outbreaks of antibiotic-resistant infections at multiple United State medical centers in the previous years.
In Nov. 2018, research conducted by the ICIJ (International Consortium of Investigative Journalists) discovered a hundred and ninety reports of ‘superbug’ infections both in the country and Europe connected to Olympus manufactured duodenoscopes. The Kyodo News Service and ICIJ found not less than fifty pending lawsuits against Olympus over the device-related infections.
How a Duodenoscope Works
The doctor inserts the snake-like, flexible device on the patient’s mouth and passes it via the esophagus, stomach, and finally onto the duodenum, also known as small intestines. The duodenoscope differs from the standard endoscopes used during colonoscopies and is specifically used in ERCP procedures.
An ERCP procedure (where a duodenoscope is used) involves the upper GI (gastrointestinal) system and allows the doctor to directly access the pancreatic and bile ducts to administer treatment to unblock the blocked ducts. These ducts may be blocked by gallstones, infection, inflammation, tumors, or any other condition.
For the best outcome, ERCP has to be done when the patient is on an empty stomach. Before the process, the doctor will administer IV medications to the patient to cause sleepiness and relaxation and perhaps induce local anesthesia to lower the pharyngeal reflex. During the ERCP procedure, the patient is usually semi-conscious and can still follow instructions to change their body position on the X-ray table. The process lasts anywhere from 15 minutes to an hour.
Generally, ECRP conducted using duodenoscopes is a safe process with its success rate ranging between 75% and 90%. However, roughly one in five patients experience complications. Various severe adverse complications are:
- Intestinal perforations
- Pancreatitis due to irritation of the pancreas
- Drug reaction
- Heart attack or irregular heartbeat
- Depressed breathing
Since a duodenoscope allows the doctor to access the pancreatic or bile ducts directly, they’re more intricate than other scopes. Apart from a tiny, lighted camera at the tip, a duodenoscope has a hinge-enabled lever known as an elevator mechanism. This extra feature enables the physician to lower or raise material from the device’s tip to conduct biopsies or other procedures in pancreatic and bile ducts.
Three manufacturers, Fujifilm, Pentax, and Olympus America Inc., presently market duodenoscopes in the country. Olympus controls roughly 85% of the market as per the LA Times.
What You Must Know If You Have to Undergo an ERCP With a Duodenoscope
In case you must undergo an ERCP process in the future, here are certain things you should be aware of and be well informed about beforehand:
- Check the device model number: Inquire about the model number of the duodenoscope that’ll be used in the ERCP procedure. Some models have been associated with these specifically fatal infections & outbreaks, for instance, model TJF-Q180V, and have been recalled & redesigned.
- Be conscious of your risks: Discuss exhaustively with your doctor about the benefits, risks, and alternatives to the procedure. Most of the patients who contracted the infections hadn’t been informed properly or weren’t aware of the dangers of infections associated with these devices. The risk of infections and death from the ERCP procedure is still low. However, knowing there are any risks at all will keep you conscious of them.
- Inquire about the cleaning process: Speak with your healthcare provider or technicians involved in the device’s use about their procedure and policies for infection control and reprocessing the device between patients to ensure cleaning and proper handling and care are being used at the facility.
If you or your loved one has suffered a severe infection after undergoing an ERCP procedure, consult a skilled defective medical device lawyer to know your rights to recover damages.
Superbug Infections & Design Errors
In 2013, the CDC informed the FDA of a possible link between duodenoscopes and antibiotic-resistant bacteria. Antibiotic-resistant bacteria are bacteria that resist several drugs. The CDC researched one of the initial United States outbreaks in LA County, California. Bacteria discovered in the GI tract, known as CRE (Carbapenem-resistant Enterobacteriaceae) were accountable for the superbug infection outbreak.
Medical professionals deem CRE infections ‘superbugs’ since they’re resistant to several antibiotics. They are also linked to higher fatality rates. As per the West Virginia Department of Health and Human Resources, the mortality rate of people infected with CRE is approximately 50%.
In Jan 2016, the U.S Senate HELP Committee acquired FDA data on CRE infections from 1st Jan. 2010 to 31st Oct. 2015. The statistics indicated that over 400 patients were infected, and from the forty-one hospitals involved, thirty were United States’ hospitals. The committee was concerned that the number of infections could be higher compared to those reported.
At least thirty-six hospitals in the U.S had superbug outbreaks between 2010 and 2015. The hospitals recorded CRE infections associated with duodenoscopes that were used during an ERCP procedure. The most publicized outbreaks happened in the Ronald Reagan UCLA Medical Center in 2015. This resulted in several torts against Olympus.
Studies indicate that numerous failures make the superbug outbreak spread. They include:
- Failure to report and inaccuracy and lack of timeliness when reporting adverse occurrences
- Lack of medical community or public awareness of investigations into the spreading of infections through the devices
- Issues with the Food & Drug Administration’s outdated event duodenoscope database
As per the CDC, other superbug infections caused by antibiotic-resistant bacteria apart from CRE are:
- Clostridium difficile (C.diff)
- Methicillin-resistant Staphylococcus aureus (MRSA)
- Carbapenem-resistant Enterobacteriaceae
- Vancomycin-resistant Enterococcus
- Multidrug-resistant Pseudomonas aeruginosa
- Extended-spectrum beta-lactamases
- Multidrug-resistant Acinetobacter
How Duodenoscope Design Causes Infections
The superbug infection risk is higher when duodenoscopes are used compared to other kinds of endoscopes due to how they are designed. The scopes have many tiny features that make it more challenging to clean & disinfect. The cleaning procedure is known as reprocessing as per the Food & Drug Administration. Gut bacteria may gather in these tiny, movable features. Since physicians reuse the devices, the bacteria that remain on the device after cleaning might transfer from one patient to another. These bacteria may result in superbug infections, for instance, CRE.
One part where the bacteria are more likely to gather is the device’s elevator mechanism, as per The (AGA) American Gastroenterological Association. The AGA conducted a meeting with manufacturers, doctors, and regulators in 2015 in which they discussed the issue of infections. And as per the AGA press release, the infection transmission problem is rampant due to the intricate design of the duodenoscope’s elevator channel, allowing bacteria to still exist after cleaning, even when reprocessing complies with the currently approved procedures developed by the FDA and manufacturers.
FDA Regulatory Measures on Duodenoscope Defective Nature
The FDA researched superbug outbreaks in 2013 but didn’t take significant measures until 2015. In 2015, it ordered duodenoscope makers to carry out further research. These post-market surveillance researches were meant to collect information on how medical care staffers cleaned the devices and how the cleaning affected disease transmission.
In Dec. 2018, the Food & Drug Administration updated the public on the post-market studies. The investigation found there was a higher-than-anticipated contamination rate for these instruments even after their cleaning. The FDA report said the study’s outcome indicated that the manufacturer’s cleaning instructions weren’t enough to prevent infections. However, it emphasized that the possibility of patients contracting an ailment or complication from the ERCP process remained low.
Device Redesign & Monitoring
Despite the flaws in the design, there wasn’t an alternative to the scopes when the FDA issued their precautionary safety measures and warnings about these devices. The FDA cited the devices’ importance in medical processes in permitting them to stay in service regardless of the past cases of the spread of infections. Duodenoscopes have remained in use, although various companies have recalled & redesigned them.
In 2015, in its public statement, the CDC echoed that the risk of a patient developing superbug infection after ERCP is relatively lower, and for many patients, the advantages of this possibly life-saving process surpass the dangers. Irrespective of the risks of more outbreaks, the devices remained in use with the faulty design for two more years.
In Sep. 2017, the Food & Drug Administration approved the first device with a one-use cap. Model ED34-I10T from Pentax is made with a disposable cap, which the manufacturer claims will stop bacteria plus other contaminants from being transmitted from one patient to another. The first new duodenoscope was available in Dec. 2017. However, with half a million procedures conducted each year, the older designs may remain in use for years to come.
Olympus voluntarily recalled various duodenoscope models in 2016, one being model number TJF-Q180V. The company changed the elevator channel cap on approximately 4,400 devices after being cleared by the FDA. Additionally, the company updated its cleaning & disinfecting manual to add new warnings. It necessitated users to comply with all manual cleaning and pre-cleaning steps.
FUJIFILM withdrew several older versions of their scopes from the market in Jan 2017 and replaced them with newer models they believed were safer.
In Feb 2018, Pentax removed their ED-3490TK device to modify three parts on every unit. They also planned instructions for regular maintenance in their operation manual.
Duodenoscope Mass Torts and Other Lawsuits
Individuals started bringing duodenoscope suits after several U.S hospitals had infection outbreaks beginning in 2010. Often, the infections included antibiotic-resistant bacteria, with the most notable one being CRE.
Early Duodenoscope lawsuits began in 2015. In March 2015, a woman brought a duodenoscope suit in Seattle, Washington, on her husband’s behalf. The husband had contracted a life-endangering bacterial infection after undergoing a procedure whereby physicians used the device. After a few months, the medical facility in which her husband was treated (i.e., the Virginia Mason Medical Center) joined the suit claiming Olympus America Inc. didn’t reveal design defects in their duodenoscopes, which placed patients at a higher risk. By the time the Virginia Mason Medical Center joined the tort, thirty-nine patients were already sickened at the facility after exposure to the device between 2012 to 2014. The infections still occurred even after the hospital following the instructions for disinfecting and cleaning.
The Seattle-based hospital was not the only one. Per a 2016 duodenoscope investigation report by the HELP Committee, not less than sixteen hospitals in the United States recorded antibiotic-resistant infections directly connected to duodenoscopes. Professionals in the medical industry believe that the number was possibly even higher than this, but many cases weren’t reported.
Duodenoscope mass torts against Olympus America Inc. and other manufacturers claim that these instruments spread ‘superbug’ infections, which killed thirty-five patients and rendered hundreds of others sick at over forty different medical facilities globally.
The first tort case over ERCP and duodenoscope-related infections was taken to trial in 2017, and the jury ruled a 6.6 million dollar verdict.
In November 2018, Olympus was subject to at least fifty duodenoscope torts in several courts. The mass torts were seeking to recover damages for victims suffering from superbug infections. In their integrated report of 2018, the company didn’t disclose the precise number of unresolved tort cases.
As we mentioned earlier, Olympus manufacturer sells about 85% of duodenoscopes in the U.S., and it has been the center of most torts and government scrutiny. Fujifilm and Pentax also face mass torts and lawsuits.
Defective Design & Negligence
Tort cases say that the duodenoscope design leaves small crannies and nooks at the tip. The CDC and FDA established that this feature on the design created hiding areas for bacteria and made the instruments difficult to clean and sterilize between treatment processes. Federal investigators found out that the flaw in the duodenoscope design enabled the bacteria to survive even when doctors followed all the manufacturers’ and disinfecting instructions.
Tort cases allege that duodenoscope manufacturers were aware that their devices were defective, but they didn’t warn the consumers or provide sufficient cleaning instructions to protect patients from infections. Additionally, complainants say that Olympus didn’t inform hospitals that their cleaning protocol didn’t remove all body fluids or organic material left on the device. The organic debris that sticks on this device may harbor infection. The tort cases claimed that the manufacturers knew or should’ve known that if the residual fluids contain microbial contamination, several patients would be exposed to a severe risk of injury, including deadly infections. The manufacturers’ reprocess instructions didn’t prepare the device for safe re-use. Thus, the manufacturers were held responsible due to their negligence.
How to Join a Duodenoscope Mass Tort
When a defective duodenoscope harms enough patients, the patients may come together and bring a mass tort to claim financial damages to enable them to be whole again. Through contact and communication with legal experts, every patient may join the tort and elevate the potential damages depending on the precise issue.
A mass tort case involves several different aspects and usually contains various facts and includes several plaintiffs. When the mass tort is because of the injuries caused by the defective duodenoscope, you could also involve a company, hospital, or any other responsible healthcare facility. The different kinds of damage may create various claims. Non-economic and economic damages paid by a facility or company might not be channeled to any particular patient that’s physically hurt due to device damage. Generally, a team of attorneys work jointly and might communicate with the individual or company that wishes to be part of the tort case. Statements from witnesses and other proof are accrued until when needed in court.
When you need to be part of a mass tort, you should contact an attorney unconnected to the tort as a reference point. Alternatively, you could talk to the lawyers connected to the tort itself. You may have to wait until one of the experts can interview you. The facts of the harm from the duodenoscope have to be relevant to the tort’s subject matter. In case the circumstances or damage don’t bear a direct relation or connection, you may have to file a claim against the liable person or company separately.
Generally, the tort uses experts, other professionals, testimonies from witnesses, and the proof from every experience with involved victims. If there are cases of physical harm, the evidence will support the faulty design or materials. In situations where the device didn’t have any faults originally, the tort may involve a case where the point of sale or transportation resulted in the issue. It’s best to identify the liable party, so the compensation you’re owed comes from that party, and the tort gains a higher possibility of succeeding. The attorneys may have to thoroughly investigate the cases with every victim and witness long before proceeding to court.
Your Connection to the Mass Tort
When you need to sue a company or person for a faulty duodenoscope that caused harm to you, you could consider a mass tort case. But after being interviewed with a legal professional, you may have to explain how you’re connected to the tort. Evidence is critical, and medical records about the damage or injuries caused may give a basis for your association with the case or disprove any relationship.
For a mass tort case for a defective duodenoscope to succeed in court, the attorneys must show that the faultiness caused you and other victims harm. As far as a tort case is concerned, it’s possible to present a staggering amount of proof to show the jury panel or judge that the accused is liable for the injury. But evidence of the faultiness is necessary. An attorney retained by one of the plaintiffs will present the tort and prove how the faulty device led to the harm through instructed or standard use.
Contact a Defective Medical Device Attorney Near Me
Filing a claim against a product manufacturer to seek compensation for the harm their product caused you is a bold decision that needs extensive legal representation. Some complainants try handling cases on their own only to be disappointed by the outcome. Remember that product manufacturers have a team of highly skilled attorneys and substantial financial resources to fight against these kinds of claims.
This means you must hire a competent lawyer and possibly join a mass tort to stand a chance of winning. If you or your loved one develops a duodenoscope-related infection or if you lost your loved one due to the infection, you can pursue compensation. Consumer Alert Now is currently assisting persons with duodenoscope-related injuries nationwide in finding skilled lawyers to litigate their cases.
We want corporate negligence victims to obtain justice and work to help link them with a person who understands their suffering and will work tirelessly to secure fair compensation for them. Our legal guidance helps you to know if the device affected you and how you may be compensated. For a consultation and case evaluation, please contact us at 800-511-0747 today.