March 23, 2015 — A woman from Washington who was infected with an extremely dangerous “superbug” has filed a lawsuit against Olympus, the manufacturer of a duodenoscope that transmitted the infection.
The lawsuit was filed by Debbie Newton, who underwent an ERCP procedure in February 2013 for the treatment of gallstones. Doctors used Olympus’ TJF-Q180V duodenoscope.
Soon after the procedure, she was hospitalized with heart failure, respiratory failure, renal failure, pancreatitis, septic shock, bacteremia (bloodstream infection), and infections in her pancreas, colon, and kidneys.
The lawsuit (PDF) blames her infection on a design modification to the TJF-Q180V, which made it more difficult to sterilize:
“The “sealed elevator wire channel” and the associated moving parts and the design of the forceps elevator mechanism of the Q180V Scope are collectively defective … rendered it extremely difficult — if not impossible — to consistently and safely reprocess the scope.”
The FDA has warned that the scope was sold without proper clearance since 2010, and remains on the market without approval because the FDA is reluctant to recall life-saving medical devices.
Ms. Newton was treated at Harborview Medical Center in Seattle. Another hospital in Seattle, Virginia Mason Medical Center, reported an outbreak of infection earlier this year.
Between 2012 and 2014, at least 35 people were infected with antibiotic-resistant “superbug” infections, known as CRE, after undergoing ERCP procedures with the Olympus duodenoscope. At least eleven patients died, but it is not clear that the infection caused all of the deaths because many of the patients also had cancer.
Virginia Mason and other hospitals say they cleaned the scope according to instructions from Olympus. Many lawsuits now claim those instructions were inadequate. Now, each scope goes through a more rigorous cleaning procedure and is held for 48 hours before it can be used on another patient.
Do I have a “Superbug” Infection Lawsuit?
The Schmidt Firm, PLLC is currently accepting CRE “superbug” induced injury cases in all 50 states. If you or somebody you know has been injured by an Olympus duodenoscope, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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