A Newport Beach woman is suing Olympus Corp., accusing the medical device maker for an outbreak of the CRE superbug at Ronald Reagan UCLA Medical Center that infected her and at least 6 other patients, killing 2.
What’s the Problem?
June 29, 2015 – Plaintiff Staci Simos filed the complaint against Olympus last Friday in Los Angeles Superior Court, alleging that she developed a CRE infection after undergoing a routine procedure with a duodenoscope last October at UCLA.
The lawsuit alleges products liability, negligence, fraud and seeks unspecified damages against Olympus. At least 3 other complaints related to the UCLA superbug outbreak have been filed against the company since March.
Olympus spokesman Mark Miller said the company didn’t request FDA approval for changes made to the device because it was not required to do so. However, the device maker had responsibilities to patients such as Simos, according to the lawsuit.
“After each use, the Q18OV scope necessarily requires cleaning and disinfecting before it can be used on a new patient,” the suit states. “A manufacturer of a medical device like an endoscope … has an obligation to develop and validate a (cleaning) protocol and to incorporate this protocol into the product’s labeling.”
Olympus “failed to take these critical steps with the redesigned Q18OV scope,” according to the lawsuit.