Although it was clear that there were problems with the Olympus TJF-Q180V duodenoscope as early as 2012, and Olympus were aware of this, it wasn’t until January 2016 that the FDA announced that the product would be recalled. The new design to replace the product would be intended to reduce the risk of superbugs when the duodenoscope was used in patients. The “closed channel” duodenoscope design has been linked to antibiotic-resistant infections, affecting more than 250 people around the world, according to a 2016 report by the U.S. Health, Education, Labor, and Pensions Committee.
These instances of dangerous and even deadly infections have led to the victims and their families taking legal action in a number of cases. Anyone who has been affected by an illness related to the use of a duodenoscope could be entitled to compensation through a personal injury lawsuit against the manufacturer.
What Is a Duodenoscope?
A duodenoscope is a medical instrument which is used to examine the top of the small intestine (the duodenum). They are hollow and flexible lighted tubes that are inserted into the mouth and passed through the throat and stomach to produce an image of the intestine. They’re different to endoscopes, which are used for procedures such as colonoscopies, because they allow access to the bile or pancreatic ducts, making them more complex. They also have a small, lighted camera at the tip, as well as a lever with a hinge that allows doctors to raise or lower accessories at the tip of the scope to perform biopsies and other procedures. Duodenoscopes are mostly used to perform an endoscopic retrograde cholangiopancreatography (ERCP), which is used to diagnose and treat problems with the liver, bile ducts and pancreas.
There are three manufacturers of duodenoscopes in the U.S.: Olympus American, Inc., Hoya Corporation, and Fujifilm Medical Systems, U.S.A., Inc. Olympus is the major manufacturer and supplier, holding about 80% of the market.
What Problems Have the Use of Duodenoscopes Caused?
An ERCP is a common procedure, with hundreds of thousands performed in the U.S. each year. The majority of procedures are carried out without problem, however a new design by Olympus in 2010 was flawed, and began to cause problems. The design from Olympus, which they called a closed-channel duodenoscope, was changed to close off a narrow internal channel. This move was made with the intention of keeping blood and other potentially infectious material out of the scope, which was hoped to reduce the chance of infection.
Because a duodenoscope is designed to be reused, it’s important that it can be cleaned properly. The new Olympus design was meant to be easier to clean and more resistant to infections than their previous design and their competitors’ products. However, investigations later revealed that the design was flawed and that the closed-channel duodenoscope allowed dangerous bacteria to remain in the device even after it had been cleaned.
In 2013, the Olympus closed-channel duodenoscope was linked to a number of antibiotic-resistant infections at the Virginia Mason Hospital and Medical Center in Seattle, Washington, as well as at the Advocate Lutheran General Hospital near Chicago. It wasn’t until almost one and a half years after this that the FDA alerted doctors and patients to the potential dangers of the device.
Between October 2014 and January 2015, there was an outbreak of CRE (carbapenem-resistant Enterobacteriaceae) infections at the Ronald Reagan UCLA Medical Center. All seven infections developed after a routine procedure using a duodenoscope, and two of the affected patients died. Four patients at Cedar-Sinai were reported to be infected by CRE over a similar period. Further investigation revealed that closed-channel duodenoscopes were linked to at least 25 cases of antibiotic-resistant infections that affected at least 250 patients worldwide, with at least 16 hospitals in the U.S. reporting problems.
Notable Duodenoscope Lawsuits
Various victims and their families have filed lawsuits relating to Olympus duodenoscopes. In 2015, the widow of one of the men who died at the Virgin Mason Medical Center filed a suit against the manufacturer and the hospital. Others have done the same, with five people making claims against the UCLA Medical Center. The first lawsuits went to trial in 2017, and Olympus have so far settled some lawsuits for undisclosed amounts. They have also faced a jury verdict of multiple millions of dollars.
In July 2017, a Washington state jury ordered Olympus to pay the Virgin Mason Medical Center $6.6 million in damages. The case was a joint one between the hospital and Therese Bigler, the widow of a man who died as a result of the superbug outbreak. The hospital was deemed to be partly responsible for her husband’s death and was ordered to pay $1 million dollars to Therese Bigler. She later raised a second lawsuit in 2018, which resulted in an undisclosed settlement amount, awarded at the same time as another widow, Deborah Shawver, was also given an undisclosed amount in a settlement.
Olympus also settled on another case in 2017 with Carla Warner, whose husband died from an infection in 2013. This case was also settled for undisclosed amount, just one month before it would have gone to trial in a North Carolina court.
In 2018, The Japan Times reported that Olympus were facing at least 50 lawsuits relating to superbug infections caused by duodenoscope use. However, Olympus have not revealed how many lawsuits they are currently facing.
Making a Claim for Duodenoscope Injuries and Deaths
If you or a loved one has suffered damages as the result of a procedure with a duodenoscope made by Olympus, or perhaps by another manufacturer, you could have a case for compensation. A lawyer experienced with this type of case can help. Attorneys who specialize in class action and mass tort cases can assist in this type of negligence case, where those who have been affected can benefit from joining forces with each other. Highly experienced and skilled attorneys are able to help assess individual cases and their chances of positive results.