When medical device maker Olympus Corp of Americas redesigned its duodenoscope to make it easier to use, it also inadvertently made the scope more difficult to clean, which has led to the alleged outbreak of the multidrug-resistant superbug carbapenem-resistant enterobacteriaceae (CRE). The FDA has also come under fire for allowing the redesigned Olympus TJF-Q180V duodenoscope on the market without evidence that the medical device could be cleaned properly between uses to avoid patient-to-patient transmission of bacteria. If you underwent an Endoscopic Retrograde Cholangiopancreatography (ERCP) using an Olympus duodenoscope, and you have since been diagnosed with a dangerous, drug-resistant bacterial infection, consult a reputable product liability lawyer today to discuss your legal options.
Even when the TJF-Q180V duodenoscope is cleaned according to Olympus’ instructions, experts warn that bacteria can still survive in the grooves of the device, possibly exposing patients to serious infections. In August 2015, Olympus provided hospitals with additional techniques they could use to clean the scopes, but admitted that it could still not guarantee that the new cleaning techniques would guarantee the safety of the medical devices. Unfortunately, because there are no alternative devices for ERCP at this time, the FDA indicated in October 2015, that “the continued availability of duodenoscopes is in the best interest of the public health.” However, according to the FDA, “the results of the postmarket surveillance studies could help inform […] new labeling for the devices to include different reprocessing instructions or other administrative or regulatory actions necessary to protect the public health.”
The Olympus TJF-Q180V model duodenoscope is a medical device commonly used in a procedure called Endoscopic Retrograde Cholangiopancreatography (ERCP), a potentially life-saving procedure used to diagnose or treat diseases of the liver, pancreas and bile ducts, including cancer. The snake-like, lighted duodenoscope is inserted into the body through the throat or anus during bile duct, pancreatic duct and gallbladder procedures, to examine and remove blockages from the ducts that drain the liver. According to the U.S. Centers for Disease Control and Prevention (CDC), use of duodenoscopes like the Olympus TJF-Q180V scope can prevent the need for more invasive procedures, like surgery. However, because duodenoscopes are more complex instruments than other endoscopes, the devices can be more difficult to clean and disinfect.
According to a warning issued by the U.S. Food and Drug Administration (FDA) in February 2015, the Olympus TJF-Q180V scopes contain grooves and crevices near the camera at the tip of the device that make it extremely difficult to clean, which increases the risk of the device harboring microorganisms and causing bacteria to be transferred from patient to patient. Medical officials believe possible exposures to potentially deadly “superbug” infections from contaminated duodenoscopes may have taken place during surgeries performed from October 2014 to January 2015, and it was shortly after the infection risk was discovered that the FDA announced it had never approved the Olympus scope. As a result, the agency is “closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli.”
Following hundreds of “superbug” infections and at least two deaths reported at the UCLA Ronald Reagan Medical Center in early 2015, an investigation was launched by the FDA and medical experts, which linked the deadly outbreak to the TJF-Q180V model duodenoscope manufactured by Olympus. According to reports, Olympus never obtained approval from the FDA for its redesigned duodenoscope, which was intended to make the medical devices easier to use, but actually made them harder to clean. As a result, the duodenoscopes may increase the risk of potentially deadly bacteria being transferred from patient to patient.
When it came to light that the FDA had never approved the TJF-Q180V model duodenoscope, Olympus explained that it had redesigned the scope and wasn’t aware that it required FDA approval for the new-and-improved product, but some experts say that problems with the Olympus scope go beyond lacking FDA approval. “The public should understand that the standards for cleaning such devices for marketing are too weak,” says Dr. Michael Carome, Director of the Health Research Group at Public Citizen. “We likely would still be facing the same public health threat caused by these devices even if the company had sought FDA clearance.”
While the FDA has announced that it doesn’t plan to take any action against Olympus for its unapproved duodenoscopes, patients affected by the allegedly defective medical devices may pursue legal action against Olympus for injuries, medical expenses, pain and suffering, and other damages allegedly associated with TJF-Q180V duodenoscope superbug infections. The following are lawsuits that have been filed recently over infections allegedly caused by the Olympus duodenoscope:
February 2015 – An 18-year-old patient files a lawsuit against Olympus, accusing the company of negligence for selling a medical device that caused him to suffer CRE, which is highly resistant to antibiotics. The patient has only a 50% chance of survival.
February 2015 – Another wrongful death claim is brought against Olympus on behalf of a 48-year-old woman who died after contracting a bacterial infection during a liver transplant in 2014.
February 2015 – A Washington woman files a wrongful death claim on behalf of her husband, who was one of 11 patients who died following diagnostic medical procedures at Virginia Mason, which the lawsuit claims used duodenoscopes.
November 2009 – The FDA issues a safety communication cautioning doctors and patients about the potential for cross-contamination in endoscope processing.
2013 – The CDC notifies the FDA of a possible link between duodenoscopes and multidrug-resistant bacterial infections.
February 2015 – The Olympus TJF-Q180V scope is implicated in the deaths of two patients and the possible infection of close to two hundred others.
February 2015 – The FDA issues a safety communication warning that the complex design of ERCP duodenoscopes may impede effective cleaning, meaning the devices may not be properly disinfected or sterilized.
March 2015 – Cedars-Sinai Medical Center in Los Angeles and Hartford Hospital in Connecticut report several cases of superbug infections linked to the Olympus scope.
November 2010 – Endoscopes used for ERCP can act as a reservoir for extended-spectrum beta-lactamase (ESBL)-producing Klebsiella pneumoniae, a contamination that may be avoided with rigorous application of cleaning, disinfection and drying, according to research published in the medical journal Endoscopy.
June 2013 – A study published in the American Journal of Infection Control highlights the transmission of carbapenemase-producing Klebsiella pneumoniae by contaminated endoscopic instruments.
October 2014 – Exposure to duodenoscopes with bacterial contamination was associated with the apparent transmission of New Delhi metallo-β-lactamase (NDM)-producing E coli among patients at one hospital, according to a study published in The Journal of the American Medical Association.
October 2014 – An editorial published in The Journal of the American Medical Association poses the question of whether better approaches to cleaning duodenoscopes are needed, to prevent patient-to-patient transmission of bacteria.
Before it was linked to the deadly superbug outbreak, the TJF-Q180V duodenoscope manufactured by Olympus had been used in more than 500,000 procedures annually, which means the number of infections associated with the duodenoscope is likely underreported. “It’s highly likely many hospitals around the country have had outbreaks, and they haven’t been able to connect the dots until this problem was disclosed at UCLA,” said Lisa McGiffert, director of the Safe Patient Project at Consumers Union. “It’s just a little later – especially for those who got infections and maybe died as a consequence.” Lawsuits brought against Olympus for superbug infections allegedly caused by the TJF-Q180V duodenoscope include allegations that the device maker:
The Olympus TJF-Q180V duodenoscope first became available in 2010, and remained on the market for four years before federal health regulators realized the medical device had never been cleared by the FDA. Unfortunately, during that time, hundreds of thousands of patients were exposed to the duodenscopes, and may have suffered potentially deadly superbug infections. If you believe you have been adversely affected by side effects of the Olympus duodenoscope, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by potentially dangerous products, and can help put you in touch with an attorney who has experience handling duodenoscope infection claims.