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A judge in Seattle has ordered a new trial in the duodenoscope lawsuit of Richard Bigler, a man who died at the age of 57 after contracting a virulent infection. Bigler's widowed spouse blames her husband's 2013 death on Olympus Corp., the Japanese medical company behind a medical device tied to a series of fatal superbug outbreaks around the world.
Learn more about these lawsuits from a Duodenoscope attorney.
In July 2017, the first civil superbug lawsuit came to an end, when the Virginia Mason Medical Center was awarded nearly $7 million in compensation. The Seattle hospital was the site of a deadly superbug outbreak in 2013. At least 39 patients were infected due to contaminated duodescopes made by Olympus. To date, 18 of them have died, the Seattle Times reports.
In the wake of this tragedy, Virginia Mason Medical Center and Theresa Bigler made the unusual decision to team up in a civil lawsuit against Olympus. Court proceedings uncovered substantial evidence to suggest that Olympus Corp. had failed to warn the public in time.
Internal emails disclosed during discovery appear to show one of the company's leading executives, Susuma Nishina, instructing US-based employees not to warn American hospitals of the risk. And key expert witnesses cast doubt on Olympus' dedication to public safety. To counter, Olympus accused the hospital of failing to follow manufacturer-approved cleaning instructions, an argument that held little water for a jury in the King County Superior Court.
After 8 weeks of trial, the jury had heard enough to reach judgment in favor of the plaintiffs. Virginia Mason Medical Center was awarded $6.6 million in compensation, with $1 million of the award meant for Theresa Bigler and her family.
The jury's verdict, however, was not an unqualified success for Olympus' opponents. Despite granting significant damages, the jury rejected the plaintiffs' key argument that Olympus' duodenoscope (model TJF-Q18oV) was defective in design and unreasonably dangerous. Even so, jurors felt that the company's warnings had been inadequate.
Now, after appellate review, Bigler and her children may have another chance to hold Olympus accountable for their loved one's tragic death. In a court order issued on Tuesday, January 16, 2019, Judge Steve Rosen of the King County Superior Court announced that, during initial court proceedings, Olympus had failed to disclose internal documents as required.
As the Los Angeles Times reports, a series of corporate emails sent in 2008 appear to demonstrate that Olympus executives were aware of a potential defect in the duodenoscope's design as many as 4 years before the device was released to the market in 2010.
Olympus provided the emails during discovery, but didn't translate them from Japanese as the Court had ordered. Concluding that Olympus had committed "willful discovery violations," Judge Rosen granted the plaintiffs' request for a new trial, saying their ability to prepare for the case had been "substantially prejudiced" by Olympus' alleged misconduct.
In fact, the letters only came to the attention of plaintiffs' attorneys after an Olympus employee made passing mention to hospital tests during the first trial." Olympus robbed the Bigler family of a full and fair trial," a plaintiffs' attorney told the Los Angeles Times. "The family is grateful they will get another chance to hold Olympus accountable." Olympus is planning to appeal Judge Rosen's opinion.
In 2013, the Centers for Disease and Control Prevention noted a troubling trend. The federal agency had been tipped off to a series of bacterial outbreaks in hospitals around the country. The outbreaks involved so-called "superbugs," bacteria that have become resistant to multiple forms of antibiotics.
And it seemed that duodenoscopes, many of them manufactured by Olympus, were helping the infections spread.
Duodenoscopes are thin, tube-shaped medical devices that physicians use to create internal images of the small intestine and drain fluid from blocked ducts. Unfortunately, the devices can also spread bacterial pathogens from one patient to another; duodenoscopes are designed to be re-usable, but are exceedingly difficult to clean thoroughly.
Since 2013, experts at the US Food & Drug Administration have struggled to develop a protocol that would help clean duodenoscopes adequately, but a permanent solution has yet to materialize. Meanwhile, dozens of patients have died due to virulent infections that most experts believe can be attributed to the duodenoscope's risks.
Olympus is now at the center of a federal criminal investigation in New Jersey, where prosecutors are busy attempting to figure out how much the company knew about the dangers of its medical device.
Continue Reading: FDA Slams Duodenoscope Manufacturers Over Postmarket Studies
