A Kirkland woman who says she developed a ‘superbug’ infection after a treatment at Harborview Medical Center is suing the maker of the scopes. Harborview officials say they have no record of infections tied to the devices.
A Kirkland woman who says she developed a life-threatening “superbug” infection at Harborview Medical Center is suing the maker of medical scopes tied to similar infections in Seattle and across the nation.
Debbie Newton, 54, claims she contracted a devastating infection known as CRE, or carbapenem-resistant Enterobacteriaceae, after a Feb. 7, 2013, procedure at Harborview that used a specialized duodenoscope made by Olympus America Inc.
Harborview officials said this week they have no record of a CRE infection linked to the scopes.
“I was in a great deal of pain for a long time,” said Newton, a former marketer for technology products.
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The devices have been tied to an outbreak of multidrug-resistant infections that sickened dozens of people at Seattle’s Virginia Mason Medical Center between 2012 and 2014 — and recently they’ve been implicated in outbreaks in Los Angeles, Pittsburgh and Philadelphia.
On Thursday, the federal Food and Drug Administration (FDA) announced Olympus has issued new guidelines for cleaning the devices after tests showed company instructions did not demonstrate “an adequate safety margin.” The FDA previously had warned the devices could remain contaminated with bacteria even after being cleaned according to manufacturers’ instructions.
In Newton’s case, within hours after what was to be a routine procedure to treat gallstones, she was placed on life support due to “heart failure, respiratory failure, renal failure, pancreatitis, septic shock and bacteremia,” according to medical records cited in the complaint filed last week in the Pennsylvania Court of Common Pleas in Philadelphia.
Two years later, Newton remains nearly incapacitated by infections caused by Klebsiella, E. coli and enterococcus bacteria, the lawsuit states. After hearing recent media reports about a rise in similar superbug cases, Newton decided to pursue legal action.
Harborview officials, however, said a review of hospital cases from January 2013 to the present showed no CRE infections tied to scopes after the procedure known as ERCP, or endoscopic retrograde cholangiopancreatography. State health officials say they have no record of any CRE infections reported by Harborview during that time.
The lawsuit, filed by the McEldrew Young firm of Philadelphia, seeks damages of at least $200,000 from Olympus, the Pennsylvania manufacturer of most of the scopes used in some 500,000 procedures in the U.S. each year.
It alleges the TJF-Q180V scope used in Newton’s procedure had a design flaw, and claims Olympus failed to seek appropriate FDA approval for a new version that included changes that make it impossible to clean correctly, raising the risk of spreading infection. The claim says Olympus failed to validate cleaning protocols.
Olympus did not have so-called 501(k) clearance for the redesigned Q180V scope in late 2013 or 2014, the FDA has said. Olympus has since filed for the approval, which is pending.
FDA officials declined to urge a voluntary recall due to Olympus’ large market share. Pentax and Fujinon make similar scopes.
Agency officials said the risk of contracting a superbug infection from the scopes is much lower than the risk of not performing the procedures that snake the flexible device down the throat and into the gut to treat problems with the pancreas and bile ducts.
Olympus sent the new cleaning guidelines Thursday to users of Q180V scopes. The FDA said the firm provided reports in September to verify their instructions result in a high disinfection level, reducing the risk of dangerous bacteria by 99.9999 percent.
Also, Olympus spokesman Mark A. Miller said a new cleaning brush will be available in May to enhance the procedures. Miller did not immediately respond to requests for comment.
Dr. Andrew Ross, Virginia Mason’s gastroenterology section chief, said the instructions come after the hospital started new test-and-hold procedures. “This is what we’ve been saying: That the manufacturers’ guidelines that have been in place up until today have been inadequate,” he said.