Theresa Bigler's and Deborah Shawver's husbands died after contracting a super bug from a medical scope at Virginia Mason Medical Center.
Medical-scope maker Olympus Corp. has agreed to pay an undisclosed sum to settle lawsuits by two Seattle-area women whose husbands died after contracting “superbug” infections following procedures involving the company’s flawed medical device.
In the meantime, in a separate plea agreement with the U.S. Department of Justice this week, the Tokyo-based company was fined $80 million and ordered to pay $5 million in criminal forfeiture. A former Olympus executive, 62-year-old Hisao Yabe, pleaded guilty in New Jersey to distributing the suspect duodenoscopes after not filing reports regarding scope-caused infections.
The husbands of Seattle residents Theresa Bigler and Deborah Shawver were two of 18 people who died from drug-resistant “superbug” infections after procedures at Virginia Mason Medical Center using the company’s TJF-Q180V duodenoscopes. Bigler’s original suit against Olympus went to trial in 2017, after which a jury awarded Virginia Mason $6.6 million and ordered the hospital to pay Theresa Bigler $1 million for the loss of her husband, Richard. The jury, however, did not find the scope’s design was flawed and declined to order punitive damages.
However, in January, King County Superior Court Judge Steve Rosen ordered a new trial after it was revealed that Olympus had failed to properly disclose internal emails that warned of possible problems with the scopes as early as 2008.
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At issue was the design of the company’s duodenoscopes, snakelike tubes threaded down a patient’s throat for diagnostic examinations of the throat. Doctors use the scope to diagnose and treat problems in the digestive tract. About 700,000 such ERCP procedures are performed annually in the United States.
Last year, Olympus recalled all 4,400 of its TJF-Q180V duodenoscopes — the model used in Bigler’s case — and made repairs to reduce the risk of bacteria becoming trapped inside the reusable scope after cleaning.
At least 35 patients in American hospitals have died since 2013 after developing infections tied to that model of scope.
Bigler’s attorneys argued that Olympus was reckless in not warning U.S. hospitals about previous superbug outbreaks and for failing to fix a design flaw that hindered cleaning and allowed dangerous bacteria to become trapped inside the reusable scopes.
Shawver’s and Bigler’s attorney, David Beninger, said the civil case helped uncover problems with Olympus’ scopes and aided the federal investigation.
“As a result of our case, our trial and our continued case, the feds were able to step in and hopefully make changes to make everybody safer,” he said.
Richard Bigler was being treated for pancreatic cancer in 2012 at Virginia Mason when a contaminated scope infected him with an antibiotic-resistant bacteria and he died.
Shawver’s lawsuit over the death of her husband, Larry Rutter, was set to go to trial in October of next year. More than 25 lawsuits have been filed against Olympus nationally.
Beninger said Virginia Mason and Olympus have been working to make scope procedures safe for patients. “They worked to make institutional changes and worked together to make changes on the device side, which is so important to the community,” he said.
Virginia Mason did not return calls for comment.
The settlement was announced Monday, the same day the U.S. Food and Drug Administration (FDA) issued a safety warning regarding the scopes made by Olympus and two other producers, Pentax and Fujifilm. The FDA had required the companies to test scopes in-use at heath-care facilities to make sure the devices were being properly cleaned by health-care professionals. The study found that 3 percent of scopes that were properly collected tested positive for low-level contamination and were not likely to cause infections. Another 3 percent tested positive for bacteria linked to E. coli and Staphylococcus aureus, or staph infection.
The FDA is urging hospitals and health-care facilities to closely follow manufacturer cleaning instructions and to “consider implementing” additional cleaning and sterilization. The FDA also wants hospital workers to scrutinize a component of the duodenoscope that is difficult to clean and to reclean it if needed.
The deaths resulting from the drug-resistant infections spurred Washington Sen. Patty Murray, the ranking member on the Health, Education, Labor and Pensions Committee, to conduct an investigation, which led to a number of legislative actions, such as requiring scope manufactures to show that their reusable devices can be thoroughly and properly cleaned between uses.
In response to the settlement, Murray said, “Patients deserve to know that the medical equipment they rely on for critical procedures is safe, and when it’s not they deserve to have those responsible held accountable … I’m going to continue monitoring this issue to ensure the well-being of families in Washington state and across the country.”
The federal agreement stipulates that Olympus will push through, “extensive compliance reforms.” The former executive, Hisao Yabe, 62, who pleaded guilty to distributing the scopes after and not filing reports about infections caused by the scopes, will be sentenced in New Jersey on March 27. The maximum sentence Yabe faces is a year in prison and a fine of up to $100,000.
Information from The Seattle Times archives is included in this story.