Originally targeted in a lawsuit by widow Theresa Bigler, of Woodway, Virginia Mason Medical Center is joining forces to sue the device-maker tied to outbreaks of ‘superbug’ infections in Seattle and elsewhere.
Virginia Mason Medical Center is joining with the widow of a man who contracted a “superbug” infection at the hospital to sue makers of a medical scope tied to outbreaks that allegedly sickened nearly 40 people in the Seattle area — and dozens more across the country.
Hospital officials announced Monday that Theresa Bigler, 59, of Woodway, has agreed to team up with the hospital in seeking damages from Olympus America in connection with the August 2013 death of her 57-year-old husband, Richard Bigler.
Together, they said, they hope to correct what she and hospital officials have described as a badly designed and poorly regulated medical device.
At least 39 people developed multidrug-resistant infections allegedly spread by dangerous bacteria that remained on specialized duodenoscopes even after they were cleaned according to manufacturers’ directions, health officials said.
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At least 18 Virginia Mason patients affected by the outbreak have died, although the role the infections played in their deaths, if any, isn’t clear.
Theresa Bigler filed a lawsuit in March that targeted both Virginia Mason and Olympus, seeking damages for the wrongful death of her husband, who had pancreatic cancer. The suit announced Monday by Virginia Mason is a cross claim in answer to that.
“Virginia Mason was misled and misinformed by Olympus as to the safety of its devices,” said John Gagliardi, the Luvera Law Firm lawyer representing Bigler, whose lawsuit still names Virginia Mason as a defendant.
He said evidence shows it’s likely Olympus had known for years that the devices could spread bacteria, but that the firm never informed Virginia Mason or other hospitals.
Mark A. Miller, a spokesman for Olympus, said the company doesn’t normally comment on lawsuits. However, he added in a statement, “we are continuing our investigation into the reports at Virginia Mason to be able to provide a more thorough and balanced perspective on the issues including potential causes of the infections.”
Across the U.S., duodenoscopes from Olympus and two other device-makers have been linked to 142 multidrug-resistant infections in patients since 2010, according to the Food and Drug Administration.
The patients all underwent procedures known as ERCP, or endoscopic retrograde cholangiopancreatography, which diagnoses and treats bile-duct and pancreatic problems.
Virginia Mason spent at least $1 million to implement a culture-and-quarantine protocol that tests cleaned scopes for dangerous bacteria and holds them until they’re safe to use. The FDA and Olympus have issued new safety warnings and guidelines for cleaning in the wake of the outbreaks.
Theresa Bigler’s original lawsuit, which would benefit her and her four adult children, claimed that Virginia Mason had failed to report the infections and deaths as required under state law. In addition, she said the hospital failed to notify patients or family members that the infections had occurred.
“Initially, I was upset and sad that I didn’t receive a phone call I should have expected from them,” Bigler told reporters Monday. But after discussions with the hospital, she said, she welcomed Virginia Mason’s efforts to hold Olympus accountable.
“I hope by joining with us, we’ll strengthen our fight so other families don’t have to go through what we’ve had to go through.” she said.
Virginia Mason officials originally declined to notify patients about the outbreak, saying there was no ongoing public-health risk and no action to take. They later reversed course.
In addition, the hospital originally said there were 32 patients involved, when internal emails and state documents confirmed that 39 patients developed the multidrug-resistant infections spread by the scopes.
Dr. Andrew Ross, the hospital’s section head for gastroenterology, said Virginia Mason has now notified all patients and families affected by infections. In addition, they warned others who may have undergone the ERCP procedures between late 2012 and early 2014, the period of the outbreak.
Since implementing their test-and-hold protocol, no new infections have been detected. “The outbreak has ended,” Ross said.