Olympus Scopes Infection FAQ

Between 2010 and 2015, people all over the country came face-to-face with a deadly superbug outbreak. Infected patients were from Pittsburgh, Seattle, Los Angeles, and the Netherlands. The victims had all had a procedure involving a medical scope called the Olympus TJF-Q180V duodenoscope.

After having the procedure, the patients tested positive for a superbug that was so resistant to antibiotics that health officials called it a "nightmare bacteria." The infection patients caught was carbapenem-resistant Enterobacteriaceae (CRE).

Here, we will answer questions about the Olympus scope infections and the litigation surrounding the device.

What is the Olympus Scope?

The Olympus scope, or duodenoscope, is a medical device used in a procedure known as endoscopic retrograde cholangiopancreatography (ERCP). Doctors insert a flexible, snake-like flexible endoscope down a patient's throat and into the digestive tract.

The Olympus Scope allows doctors to treat a variety of conditions, including:

• Liver disease
• Pancreatic issues
• Bile ducts issues
• Certain forms of cancer

The scope is still used today despite the health problems in 2012.

How many medical procedures annually involve duodenoscopes?

The U.S. Food and Drug Administration (FDA) reports that more than 700,000 procedures are done yearly using duodenoscopes.

Not all procedures involved scopes manufactured by Olympus Corp. The FDA also investigated the scopes manufactured by Pentax and Fujifilm.

How did patients get sick from the Olympus Scope?

One of the defects with the Olympus scope is that it contains microscopic crevices nearly impossible to reach with a cleaning brush. This makes it extremely difficult to disinfect properly.

CRE bacteria became trapped in the crevices near the tip of the devices. It accumulated in the cracks and went on to infect patients. Lawsuits alleged that Olympus failed to instruct hospital personnel on how to clean the scopes.

Did the FDA approve the use of duodenoscopes?

The FDA had not approved the Olympus scope in 2012 when the outbreak occurred. It wasn't until 2019 that the FDA finally approved a single-use version of the duodenoscope.

The FDA didn't recall the scope. It cited widespread use of the duodenoscope and good faith on the part of Olympus. After the outbreak, the FDA warned that the Olympus scopes' design made them difficult to clean thoroughly and could result in infections.

What was Olympus' response to the outbreaks?

From the time the infections appeared in January 2010, Olympus denied liability. The manufacturer in Japan argued that the hospitals were responsible for the diseases. The manufacturer claimed that the hospitals didn't clean the devices properly.

In March 2014, a research team at the University of North Carolina School of Medicine found that, even after following the manufacturer's cleaning and sterilization protocol, more than 40% of the scope remained contaminated.

The company still denied wrongdoing. It chose not to warn patients and healthcare providers of the outbreaks. Instead, it handled outbreaks on a case-by-case basis. Finally, in January 2016, Olympus recalled the devices. Olympus only recalled the devices after a Congressional report criticized the manufacturer for not handling the outbreaks properly.

What are the symptoms of a CRE infection?

One of the challenging things about a CRE infection is that many of the symptoms are of the end-state variety. For example, one of the symptoms is sepsis or septic shock. Sepsis is an infection of the bloodstream.

Unfortunately, by the time a doctor can diagnose sepsis, the patient is usually in the hospital and in a dire state.

Some of the other symptoms of CRE infection include:

• High fever
• Severe urinary tract infection (UTI)
• Severe pneumonia
• Low blood pressure
• Bluish-gray skin

If you notice these symptoms and have recently been near someone with CRE, immediately go to the emergency room. The same is true if you experience an adverse event after a procedure using an invasive instrument such as an endoscope.

Are certain people at a higher risk of CRE infection?

Certain groups are more susceptible to a CRE infection since CRE is transferable through people and contaminated instruments. Healthcare professionals are at the highest risk since they work with infected patients all day long.

Some of the other risk factors for a CRE infection include:

• History of antibiotic treatment
• People who undergo a procedure such as an endoscopy
• Individuals who come into contact with someone infected with CRE

If you fall into any of these groups, be careful. Patient safety and infection control should be primary concerns for hospitals and medical facilities. However, if they do not thoroughly sterilize their equipment and rely instead on manual cleaning, you could be at risk.

How do medical centers treat CRE infection?

The key to treating CRE infections is to catch them early. Once the infection reaches a patient's bloodstream, there is a 40-50% chance that they'll pass away. The microorganisms carrying the bacteria multiply and latch on to hosts quickly. When you go to the hospital, it may be too late to treat your infection effectively.

For those patients who seek treatment early, the only option is a course of antibiotics. The problem is that the bacteria that causes CRE infections is resistant to even the most potent antibiotics.

U.S. hospitals now have protocols for dealing with this infection, but that does not mean it is any less dangerous.

Did the FDA recall the Olympus Scope?

The manufacturer of the Olympus Scope eventually issued a voluntary recall of their devices. However, they did not take the device off the market. While the company was repairing defective devices, people continued to get sick.

After pressure from the FDA and the Centers for Disease Control and Prevention (CDC), the manufacturer finally agreed to redesign their scope.

Since the 2010-2015 outbreak of CRE infections, other companies have designed safer alternatives to the Olympus scope.

Healthcare providers also learned more effective endoscope reprocessing methods. This involved high-level disinfection and infection prevention for all facilities that performed this procedure.

Are Olympus Scope infections a product liability or medical malpractice issue?

People who got sick from contaminated Olympus scopes may have had potential claims against both the scopes's manufacturer and their healthcare provider.

If a patient could prove that the device was defective, they could file a product liability lawsuit against Olympus. However, if the doctor or healthcare facility failed to disinfect the scope correctly, they could file a medical malpractice lawsuit instead.

Are there currently any lawsuits against Olympus?

As of November 2022, Olympus had resolved most of the lawsuits against them. The company did witness a significant jury award of $6.6 million in the first Olympus trial in 2017. Over the next few years, the manufacturer settled many other pending cases.

According to Olympus Corp.'s public filings in 2021, the company no longer allocated funds and resources to CER infection litigation.

Contact an Attorney if You Suffered an Olympus Scope Infection

You may be entitled to compensation if you or a loved one became sick after undergoing a medical procedure involving the Olympus Scope. An experienced personal injury attorney can help you pursue damages against the device manufacturer.

If you want to learn more about your legal options, an excellent first step is to talk with a local attorney.