Olympus Duodenoscope Infection Lawsuit
On January 15, 2016, the Food and Drug Administration (FDA) announced that Olympus America, a medical and surgical products manufacturer, was recalling its controversial TJF-Q180V duodenoscope to update it with a new design and labeling modifications. These modifications are meant to help reduce the risk of “superbug” bacterial infections when the duodenoscopes are used in patients.
Critics assert that the recall should have come much earlier, as Olympus was aware since no later than 2012 of flaws in the design of its closed-channel duodenoscope that increased the risk of serious infection. According to a 2016 U.S. Senate Minority Staff Report issued by the U.S. Health, Education, Labor, and Pensions Committee, so-called “closed channel” duodenoscope-related infections have been linked with antibiotic-resistance infections that have sickened at least 250 patients worldwide. As the awareness of the problems with these devices continues to grow within the medical community, we will likely see an increase in the number of infections linked to these devices.
Victims of these infections and their families may be eligible to file personal injury lawsuits against the manufacturers of these devices for failing to warn of the serious dangers, and for defectively designing these medical devices which are now known to carry unacceptable health risks.
What is a TJF-Q180V Duodenoscope?
A duodenoscope is a small, tube-like medical device used to examine the duodenum, which is the first part of the small intestine just beyond the stomach, as well as nearby structures like the gallbladder and pancreatic duct. The device is used mainly in a procedure called an endoscopic retrograde cholangiopancreatography (ERCP), which is meant to diagnose and treat health problems in the liver, bile ducts and pancreas.
More than 500,000 ERCP procedures are performed each year. In these common procedures, the doctor inserts the long, flexible, lighted duodenoscope, which is about the same diameter as a pen, through the mouth, down the esophagus, and into the stomach and duodenum. Doctors can view the area through a chip at the tip of the duodenoscope that transmits images to a TV screen, and can also pass other catheters through the duodenoscope to inject die for X-rays, perform biopsies, or insert stents to relieve obstructions.
In 2010, Olympus modified the design of its duodenoscope to close off a narrow internal channel, calling the new design a closed-channel duodenoscope. The idea was to keep blood and other potentially infectious material out of the scope, potentially reducing the risk of infections. These devices are designed to be re-used in other patients, and are accompanied by specific cleaning and disinfecting instructions.
This new design was meant to create a duodenoscope that was more resistant to infections and easier to clean than others created by rival manufacturers Pentax and Fujifilm. Subsequent investigations, however, have revealed that the closed-channel design was flawed because it allowed dangerous bacteria to remain inside the device even after the device was cleaned.
Olympus TJF-Q180V Duodenoscope Sold Without Clearance
On March 18, 2014, the FDA sent a letter to Olympus, stating the company was marketing the TJF-Q180V duodenoscope without FDA clearance. After the FDA had approved the XTJF-Q160 in 2008, Olympus updated the design of the TJFQ180V with the “sealed elevator wire channel” and had not obtained proper clearance from the FDA to market the device.
Olympus, in response, has claimed that it received clearance on the previous design, and on other types of endoscopes. Thus, it did not believe that its modifications to the product design required it to apply for a new clearance of the device. The FDA noted that Olympus was required to obtain 510(k) clearance of the redesign, explaining that the new design prevented “sterilization and high level disinfection of the elevator channel,” impacting “safe use of the device.”
Olympus Duodenoscopes Linked to Superbug Infections
According to the Minority Staff Senate Report, problems linked to these devices proliferated in September 2013. That month, staff at Virginia Mason Hospital and Medical Center in Seattle, Washington, linked a number of antibiotic-resistant infections to the Olympus closed-channel duodenoscope. Around the same time, staff at the Advocate Lutheran General Hospital near Chicago reported the same thing.
At issue was the new closed-channel design, which was found to remain contaminated even after the device was cleaned. Consequently, when it was used in the next patient, it could spread residual bacteria, leading to potentially serious and life-threatening infections. Despite the reports by these two hospitals, it would be another 17 months before the FDA would alert doctors and the public to the potential risks.
In January 2015, Senator Patty Murray, a Ranking Member of the Senate Health, Education, Labor, and Pensions Committee, initiated a Senate investigation of the superbug infection outbreaks that were being seen in a number of major U.S. hospitals and their link to closed-channel duodenoscopes. The Senate investigation also sought to determine what needed to be done to correct the problem.
On March 5, 2015, CNN reported on a dangerous outbreak of CRE (carbapenem-resistant Enterobacteriaceae) infections in seven patients at Ronald Reagan UCLA Medical Center, between October 2014 and January 2015. Two of those patients died. All developed the infections after “routine” duodenoscope treatments.
CRE is a family of germs resistant to antibiotic treatment, which makes them particularly dangerous and sometimes deadly. According to the Centers for Disease Control and Prevention (CDC), these infections may cause death in up to 50% of patients who are infected.
Were the Duodenoscopes Properly Cleaned?
The FDA initially investigated hospital practices to see if they were somehow failing to follow proper cleaning instructions. The evidence showed that there were no breaches in “reprocessing,” which is what it’s called when the devices are cleaned, sterilized, and then put back into use.
As part of its investigation, the FDA asked all three duodenoscope manufacturers to conduct additional tests to find out if the devices could be adequately cleaned and sterilized between uses. The results submitted by the device manufactures showed serious issues with the device design. The companies submitted data twice from studies showing that they could not get rid of 99.9999% of all microbes when cleaning—the FDA’s standard. In other words, the companies were selling products that could not be properly sterilized for re-use.
Many experts agree that the design of the closed-channel duodenoscope makes it near impossible to completely clean. The closed channel at the top of the device has moving parts and microscopic crevices that make sterilization of the device extremely difficult. According to the FDA’s February 19, 2015 safety warning “[a]lthough the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection. Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible.”
In 2015, Olympus issued new, validated instructions for proper cleaning and reprocessing of the TJF-Q180V duodenoscope, but did not recall the device at that time.
Meanwhile, the number of reported cases of dangerous superbug infections linked to the closed-channel duodenoscopes continued to grow. Cedars-Sinai Medical Center in Los Angeles reported four patients infected with CRE between August 2014 and January 2015, which the hospital linked to a contaminated duodenoscope. Faced with these concerning reports, the Center for Disease Control (CDC) began an investigation of this growing public safety issue.
Then, on March 5, 2015, ten members of Congress sent a letter to the FDA asking when the FDA first learned that the new design of these duodenoscopes could make them difficult to sterilize and what steps were being taking to correct the problem? “Superbugs are a critical national security and public health threat,” the members of Congress wrote, “yet hundreds of thousands of patients across the nation rely on duodenoscopes. We must find a way to address this challenge, update the cleaning protocols or redesign the device, and ensure hospitals, doctors, and patients have the necessary information regarding duodenoscopes.”
Investigation Reveals Disturbing Trend in Duodenoscope-Related Infections
The investigation initiated by Senator Murray came to some disturbing conclusions. According to the Senate Minority Staff Report released in January 2016, the superbug outbreaks at the two aforementioned hospitals were not unique. Between 2012 and 2015, investigators discovered that closed-channel duodenoscopes were linked to “at least 25 different incidences of antibiotic-resistant infections that sickened at least 250 patients worldwide.”
Major hospitals around the U.S. and abroad had implicated the closed-channel duodenoscopes in the rare superbug infection outbreaks at their facilities. In the U.S., hospitals in California, Connecticut, Florida, Illinois, North Carolina, Pennsylvania, Massachusetts, New York, Washington, and Wisconsin had all linked potentially-deadly superbug outbreaks to the use of closed-channel duodenoscopes at their hospitals.
Further, the investigation revealed that by 2013, Olympus was aware of two lab reports indicating their duodenoscopes could spread bacteria even after cleaning. However, the company failed to share this information with the FDA or with medical professionals. A 2013 report by the Dutch Health Ministry also concluded that Olympus didn’t have sufficient data to show that the cleaning instructions included with the closed-channel duodenoscopes worked consistently and effectively. Researchers added that, as early as May 2012, the company was aware that the closed-channel model used at Virginia Mason could spread bacteria even after cleaning.
At least 16 hospitals in the U.S. reported antibiotic-resistant infections directly related to duodenoscopes, and reports have suggested that the number may be even higher, as the hospitals that did report the problem were large research hospitals and medical centers experienced at detecting these types of infections.
Olympus Duodenoscope Lawsuits
On March 5, 2015, Reuters reported on a Washington state widow who filed an Olympus Duodenoscope lawsuit against the manufacturer and the hospital where her husband was treated. She claimed that after battling pancreatic cancer, he passed away in 2013. According to the Complaint filed in the case, his death certificate listed drug-resistant E. coli bacteria a contributing cause of his death.
The woman’s husband was one of 31 people who were infected at the Virgin Mason Medical Center in Seattle between 2012 and 2014, of which 11 (of those 31 infected patients) have died. The infections were linked to “dirty” duodenoscopes. The woman’s case alleges that the type of duodenoscope used on her husband was manufactured by Olympus.
Other plaintiffs have followed suit, with five victims filing suit against the device manufacturer after the UCLA outbreak, alone.
Olympus TJF-Q180V Duodenoscope Recall
In January 2016, Olympus recalled and redesigned the TJF-Q180V Duodenoscope to address the issues surrounding the device and to change the design in an effort to reduce the risk of infections. The FDA has reviewed and cleared the new design. In a January 2016 press release, the FDA explained that Olympus had “modified its design of the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.”
Olympus also plans to conduct annual inspections of each scope that is in use by a facility to identify whether any wear and tear could increase infection risk, and to replace those that need replacing. The company has estimated that repairs to the recalled devices should be completed at an estimated 4,400 facilities by August 2016.
How an Olympus Duodenoscope Lawyer Can Help
If you or a loved one suffered an injury or death because of an Olympus duodenoscope (or one made by Pentax or Fujifilm), contact the duodenoscope lawyers at Chaffin Luhana for help. We have decades of experience in these types of cases, and fiercely advocate for plaintiffs who are injured by a defective medical device. We will fully investigate the case and pursue all avenues of potential compensation for you and your family.