A number of lawsuits have been filed against medical device maker Olympus Corp. for potentially fatal infections associated with the use of its TJF-Q180V duodenoscope. A duodenoscope is a slender, flexible scope inserted through the mouth and used for a variety of medical procedures, including biopsies of small intestine tissue. The design of the Olympus scopes, according to the Food and Drug Administration (FDA), made them difficult to thoroughly clean, resulting in hundreds of infections by a "superbug" known as carbapenem-resistant Enterobacteriaceae (CRE). The following is an overview of the device, the alleged negligence of the manufacturer, and other details about Olympus scope lawsuits.
Olympus Scopes and CRE Infections: Overview
Hospital staff at Virginia Mason Hospital in Seattle first traced a cluster of superbug infections to "closed-channel" duodenoscopes made by Olympus and other manufucturers in September 2013, but it wouldn't become public until The Seattle Times broke the story 16 months later. Similar outbreaks attributed to the device were reported by at least 16 other hospitals, according to U.S. Senate investigation report. The report goes on to say that neither the manufacturers nor the FDA alerted hospitals, physicians, or the public about these risks until more than a year later. In addition, Olympus failed to seek clearance from the FDA before it began selling its closed-channel duodenoscopes, a design change to an existing model.
More than 250 patients were injured worldwide as a result of inadequately cleaned closed-channel duodenoscopes between 2012 and 2015, according to the Senate report, most of them manufactured by Olympus. Some deaths also were reported, including 11 out of the 32 patients infected at Virginia Mason, but it's not clear exactly how many of these deaths were directly caused by the infections (many of the patients had terminal illnesses). Olympus has since recalled the devices, replacing the operating manual and reprocessing manual (for disinfecting the device between uses), while replacing a key part of the device.
Wrongful Death: An Olympus Scope Lawsuit
Several patients have filed lawsuits against Olympus after experiencing septic shock, high fever, sepsis, and other complications caused by CRE infections. However, since it is so difficult to treat, nearly half of those infected with the superbug have died. Such was the case with Richard Bigler, who died in 2013 after being treated at Virginia Mason Hospital in Seattle. Although he also had been battling pancreatic cancer, his death certificate listed an antibiotic-resistant form of E.coli as having played a role in his death.
Bigler's widow, Theresa Bigler, filed a wrongful death lawsuit against both the hospital and Olympus, claiming the company knew its product was unsafe but failed to take action. She claimed the hospital was negligent by not informing infected patients about the outbreak after it was discovered, but eventually dropped her suit against the hospital, which joined Bigler's suit against Olympus in May 2015.
Other Claims Against Olympus
Central to many of these lawsuits is the claim that Olympus's redesign of its duodenoscopes, with the goal of making them easier to use, made them more difficult to properly clean. Olympus had argued that hospital staff wasn't properly cleaning the devices, but eventually conceded that its cleaning instructions were inadequate, providing updated instructions to doctors and hospitals. Lawsuits alleging fraud hinge on reports (such as the Senate report) that Olympus knew of problems with infections but failed to alert the doctors, hospitals, or the public.
Plaintiff Aaron Young, who nearly died from a CRE infection after a lengthy hospital stay, sued Olympus for negligence and fraud in February 2015. His complaint claims Olympus failed in its duty to provide an "effective and validated reprocessing protocol" -- in other words, updated cleaning instructions. And by knowing the difficulty in properly cleaning the device (and the resulting danger of infection), the suit claims, the company made false representations about its safety.
Get Legal Help with an Olympus Scope Lawsuit
While success is never guaranteed in a hospital setting, certain injuries are preventable. If you believe you may have been exposed to CRE or some other superbug after being treated with an Olympus scope, it's in your best interests to explore your legal options. A great first step is to contact an experienced injury attorney right away.
Contact a qualified product liability attorney to make sure your rights are protected.