Jurors have been listening to testimony for several weeks and now will be the first to rule on medical device maker Olympus over its potentially fatally faulty duodenoscope. The Japanese maker of medical devices may be to blame for the death of defendant Theresa Bigler’s husband Richard. He died from an infection just days after a surgical procedure using the Olympus scope.
Superbug Infection Triggered by Endoscope
Richard Bigler was just one victim of an outbreak of a drug-resistant bacterial infection that swept a Seattle hospital, and others, in 2013. Several outbreaks of the infection were blamed on the Olympus scope. The infection in question is carbapenem-resistant enterobacteriaceae, or CRE, a bacterial infection that is extremely difficult to treat because it resists most antibiotics.
A common example of a CRE is E. coli, but there are many types of bacteria that can cause this infection. About half of people who develop this infection will die, and most of these are in hospitals and have some other type of illness. Healthy people with normal immune systems are not likely to die from the infection.
The Faulty Endoscope Design
The outbreaks of CRE that occurred in 2013 and that killed Bigler and others were linked to the Olympus TJF-Q180V, a duodenoscope that is used to image and assist with surgery in the duodenum, the top part of the small intestines. The scope is inserted through the mouth and has a small camera attached to it. The scope must be thoroughly cleaned and disinfected before use, or it may transfer infections from one patient to another.
The Olympus scope was found to have a fault in its design that made a part of the instrument impossible to disinfect. An elevator channel on the interior of the scope was found to be prone to collecting fluids, which could then not be completely cleaned out after being used in a patient.
Kickbacks and Settlement, Now Jury Trial
Olympus redesigned its scope, and in 2015 received approval once again from the U.S. Food and Drug Administration. It also voluntarily recalled the faulty scopes in 2016. However, also in 2016 the company agreed to pay $646 million in fines to the U.S. government which accused executives of paying kickbacks to doctors to sell their products, including the faulty scopes. Doctors and hospitals received payments, expensive meals, grants, and foreign travel and the company made more than $600 million in sales as a result.
While Olympus already agreed to the kickback fines, the current trial in Seattle is the first time the company will go up against a jury. The Bigler trial is expected to determine the course that the remaining trials will take. There are more than 25 other cases that will go to trial over deaths from the scope. Olympus is denying that it played any role in Bigler’s death and is requesting that the case be tossed. The executives are not testifying in the case, but the jury has heard several weeks’ worth of testimony and is expected to make a decision soon.