The King County jury said scope maker Olympus failed to provide adequate warnings about the medical scope or instructions. That failure harmed Virginia Mason, the jury said.
A jury ordered medical scope-maker Olympus Corp. to pay $6.6 million in damages to Virginia Mason Medical Center after a deadly superbug outbreak there — and told the hospital, in turn, to pay $1 million to a deceased patient’s family.
But jurors Monday in King County Superior Court also handed Olympus a key win, rejecting claims that the company’s flagship TJF-Q180V duodenoscope was unsafe as designed.
The case was filed by Theresa Bigler, 61, and her four children in connection with the August 2013 death of Richard Bigler, a pancreatic-cancer patient who contracted an infection linked to a contaminated Olympus scope. Virginia Mason later joined in the lawsuit against the Tokyo-based company, but the jury found it shared some blame.
The decision follows an eight-week trial, the first in the U.S. related to gastrointestinal scopes causing outbreaks of drug-resistant infections.
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An Olympus official offered condolences to the Bigler family in a statement and praised the jury.
“We are appreciative that the jury recognized that Olympus’ duodenoscope design was not unsafe and did not contribute to Mr. Bigler’s unfortunate passing in 2013,” said Sam Tarry, an attorney for the firm.
The jury also said Olympus failed to provide adequate warnings or instructions. That failure harmed Virginia Mason, the jury said.
One of the nation’s largest superbug outbreaks occurred at Virginia Mason, where 39 people’s infections were linked to the scopes. Eighteen died. The Seattle hospital said the patients who died had underlying illnesses.
Bigler’s attorneys cast the decision as a win for patient safety.
“Olympus hasn’t been playing by the rules for some time and this verdict holds them accountable,” lawyer David Beninger said in a statement.
He said the case should send a broad signal to device manufacturers to “make patient safety a priority and not just a sales pitch.’’
Medical and legal experts said they were surprised at how well Olympus fared in this case, which was closely watched by others who have filed similar suits.
“In the jury’s opinion, the hospital shared some of the blame,” said Lawrence Muscarella, a hospital-safety consultant in Pennsylvania.
He added, “It remains to be seen what this portends for other cases on the docket.”
More than 25 patients and families around the country have sued Olympus alleging wrongful death, negligence or fraud. Federal prosecutors also are investigating Olympus and two smaller manufacturers.
Richard Bigler was one of at least 35 patients in American hospitals to die since 2013 after developing infections tied to Olympus duodenoscopes — snakelike tubes threaded down a patient’s throat to diagnose and treat bile-duct problems. Doctors use the scope to diagnose and treat problems in the digestive tract, such as gallstones, cancers and blockages in the bile duct. About 700,000 ERCP procedures are performed annually in the U.S.
Last year, Olympus recalled all 4,400 of its TJF-Q180V scopes — the model used in Bigler’s case — and made repairs to reduce the risk of bacteria becoming trapped inside after cleaning.
Olympus is the industry leader for these devices and other specialty endoscopes, with an 85 percent share of the U.S. market.
Bigler’s attorneys said Olympus acted recklessly by not warning U.S. hospitals about previous outbreaks and failing to fix a design flaw that allowed dangerous bacteria to become trapped inside the reusable scopes.
Olympus had said the scopes were safe and effective with proper cleaning and disinfection. At trial, the company said Virginia Mason was to blame for Bigler’s infection because the hospital didn’t follow the company’s cleaning instructions.
Olympus criticized Virginia Mason for not telling Bigler and other families about the infections, forcing them to find out from a newspaper account about the outbreak.
In his closing argument, Olympus attorney Mark Anderson said the Seattle outbreak would have occurred regardless of whether Olympus’ or another company’s scope was used.
Hospital officials said the scope caused Bigler’s infection and others and an expensive test-and-hold protocol for cleaning the devices, implemented by the hospital, halted the spread.
“We’re sorry for the grief and anguish experienced by the Bigler family,” the hospital said in a brief statement.
Theresa Bigler was not available for comment.
The 12-member jury, which began deliberating July 18, said the damages to Virginia Mason amounted to $25.4 million. But jurors agreed the hospital had been negligent, so they sharply reduced the damages owed to Virginia Mason.