Virginia Mason Medical Center joins suit over scopes tied to deadly 'superbug' infections
Between 2012 and 2014, 39 people in the hospital were sickened by highly resistant strains of E.coli bacteria, and 11 died.
Surgical tools stock image.
Virginia Mason Medical Center in Seattle has joined a lawsuit against Olympus America, claiming the company put patients at risk by failing to disclose design flaws in their endoscopy scopes that led to superbug infections and death.
Between 2012 and 2014, 39 people in Virginia Mason Medical Center were sickened by highly-resistant strains of E.coli bacteria, and 11 of those patients died, though other factors may have been factors in their deaths, according to the Advisory Board.
The 39 patients were infected through contaminated duodenoscopes made by Olympus, according to Virginia Mason.
[Also: 'Superbug' scopes lacked FDA clearance]
Richard Bigler was among who died of a bacterial infection caused by the medical device, according to the lawsuit brought in March by his widow, Theresa Bigler.
In a highly unusual move for a hospital, on May 11, Virginia Mason joined Bigler’s lawsuit, according to the Advisory Board.
Virginia Mason denies any fault in Bigler's death, saying Olympus hid the device's flaws and failed to tell the hospital the company's cleaning instructions were ineffective.
The lawsuit claims Olympus knew of the scope’s danger and issued warnings in Europe, but failed to alert U.S. providers.
[Also: 'Superbug' infections sicken four patients at Cedars-Sinai]
Virginia Mason’s head of gastroenterology Andrew Ross, said the hospital was misled about the risk to patients.
“Olympus failed to inform our organization about this safety risk associated with its product," he said in a statement. "Their silence on this important issue was unethical, irresponsible, and put patient lives at risk."
Olympus denies the allegations in court documents.
Olympus spokesperson Mark Miller said the company is taking the issue "extremely seriously."
Miller added that the company is working with the FDA and other regulators to enhance safeguards against superbug infections linked to its scopes.
Earlier this month, the FDA revealed that since 2010, it had received 142 reports of patient harm from duodenoscopes. However, the agency said the duodenoscopes serve an important purpose in treating patients and should not be recalled.
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At UCLA’s Ronald Reagan Medical Center, as many as 179 patients over the past year could have been exposed to carbapenem-resistant Enterobacteriaceae after having an endoscopic retrograde cholangiopancreatography. Seven patients were confirmed to have CRE infections, and two of those patients died, according to the Advisory Board.
In March, Cedars-Sinai Medical Center in Los Angeles reported four patients had been infected with CRE and up to 67 more might have been exposed after being treated with the duodenoscopes.
Twitter: @SusanMorseHFN
