SEATTLE — A Washington state woman who says she developed a “superbug” infection at a Seattle hospital has filed a lawsuit against the maker of medical scopes linked to similar infections across the U.S.
Debbie Newton, 54, says she contracted the infection in 2013 while at Harborview Medical Center for a routine procedure to treat gallstones, according to the Seattle Times.
Harborview officials say they have no record of the superbug CRE, or carbapenem-resistant Enterobacteriaceae, linked to the scopes, made by Olympus America Inc.
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. They also were linked to outbreaks in Los Angeles, Pittsburgh and Philadelphia. The bacteria can cause infections of the bladder or lungs and can contribute to death in up to half of seriously infected patients.
On Thursday, the federal Food and Drug Administration said Olympus 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.
Newton, of Kirkland, claims that within hours of having her gallstone procedure, 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 said. After hearing recent media reports about a rise in similar superbug cases, Newton decided to sue.
Harborview officials 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 about $200,000 in damages from Olympus, the Pennsylvania manufacturer of most of the scopes used in some 500,000 procedures in the U.S. annually.
It claims the scope used in Newton’s procedure had a design flaw and said Olympus failed to seek FDA approval for a new version that included changes that make it impossible to clean correctly, raising the risk of spreading infection.
Olympus spokesman Mark Miller did not immediately respond to requests for comment.
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