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Recent infections and deaths linked to deadly "superbug" bacteria at UCLA Ronald Reagan Medical Center in California led medical and legal experts as well as the Food and Drug Administration (FDA) to investigate what caused the infection to spread. Doctors and officials traced the deadly outbreak to one particular device: A specific duodenoscope, the TJF-Q180V model manufactured by Olympus. The FDA investigated two other scope manufacturers, Pentax and Fujifilm Medical Systems, and found these devices face the same problems of harboring bacteria.
Affected patients who had procedures with these tainted scopes — or their survivors — are now filing lawsuits or investigation claims against Olympus, Pentax or Fujifilm.
During procedures, doctors insert the flexible scope through the throat (or in some cases in the anus) so they can diagnose a variety of diseases. For instance, the TJF-Q180V scope was used during gallbladder, bile duct and pancreatic duct procedures. According to the FDA, the microscopic crevices in the scope's design allows bacteria to remain in the scope even after being cleaned according to manufacturer's specifications.
In the case of the Olympus scope, medical officials believe possible exposures occurred during surgeries that took place from October 2014 to January 2015. Shortly after the superbug outbreak was discovered, the FDA announced it had never approved the scope in question
In response, Olympus said it had redesigned the scope and did not think it needed FDA approval for the updated product. Since then, the scope maker applied for FDA approval. That application is pending.
Approximately 180 patients may have been infected by the carbapenem-resistant Enterobacteriaceae (CRE), commonly referred to as a superbug at UCLA’s large, Los Angles teaching hospital. A superbug is a microorganism that is highly resistant to antibiotics. In the case of CRE, 50 percent of all patient infected usually die.
These types of scopes are also linked to other types of deadly bacterial infections, and the full scope of infection across the country is not known.
Selling a product without FDA clearance
Knowingly selling a faulty product
Manufacturing a defective product
Marketing a defective product
Hospitals affected by the outbreak claim they used correct procedures when cleaning the scopes. In a recent safety warning, the FDA said following the manufacturer's instructions for cleaning the scopes does not guarantee that they are free of bacteria because the design of the scope makes it difficult to clean.
"Defendant knew, or should have known, that if these residual fluids contain microbial contamination, multiple patients would be exposed to a serious risk of harm, including lethal infection," one plaintiff alleged.
Lawsuits claim a redesign of the device is to blame for the superbug outbreak. The redesign was supposed to make the scope easier to use. However, the reconfiguration may have made the scopes harder to clean. Despite cleaning the scopes per Olympus' instructions, bacteria can still survive in the crevices of the device, putting patients at risk. The FDA also revealed that Olympus and two other scope manufacturers – Pentax Medical and Fujifilm – failed to prove the scope could be properly cleaned.
Olympus responded to the first California outbreak by explaining it provided instructions, education and guidance about how to clean its duodenoscopes effectively. It also said its TJF-Q180V model required cleaning technicians to pay careful attention to the steps required for cleaning and reprocessing. However, Olympus never proved the scope could be properly cleaned in any manner.
Along with Olympus, the FDA came under fire for allowing the devices on the market without proof that the devices could be cleaned. Consumer advocates say the FDA is too secretive and protects the industry instead of the public. Even after two failed attempts to meet sterilization requirements, the agency denied granting the scope maker a third attempt.
"This is a real flawed system," Lisa McGiffert of the Consumers Union's Safe Patient Project told The Los Angeles Times. "It is outrageous that the FDA is giving them a third try to prove these devices can be cleaned properly and the public didn't know about it till today."
The FDA declined to recall or order the TJF-1180V duodenoscope withdrawn from the market. Olympus originally put the device on the market in 2010 and never gained FDA approval. The agency cited the more than 500,000 medical procedures done each year using scopes.
"We view Olympus as having made a good-faith effort in complying with the rules," FDA spokesperson Karen Riley told The Times. "They manufacture a significant number of duodenoscopes so we were concerned that could lead to a potential shortage."
The FDA issued safety communication providing additional techniques that hospitals could use to clean the devices in August of 2015. However, the agency admitted that the techniques would not guarantee the devices were safe, and some hospitals might not have the staff or resources to use the additional techniques.
The first lawsuit was filed on behalf of Aaron Young, an 18-year-old who was infected. Young’s family alleges he was infected during a procedure in October 2014. At the time the lawsuit was filed, he was still hospitalized.
A second claim, a wrongful death lawsuit, was filed on behalf of Antonia Torres Cerda by her family after the 48-year-old woman died in November 2014. Her family claims she was infected during a liver transplant one month earlier.
Theresa Bigler, of Washington State, filed a wrongful death lawsuit on behalf of her husband, Richard Bigler, in King County Superior Court. Bigler was one of 11 patients who died after diagnostic medical procedures at Virginia Mason. The family claims a duodendoscope was used during one or more of those procedures.
Experts expect more lawsuits to be filed as more patients and families are notified of this dangerous superbug and the scope that may have led to their infection or death.