|Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia|
Olympus was slapped with another lawsuit over devices implicated in a superbug outbreak at UCLA Medical Center, adding to the company's mounting heap of litigation as it faces pushback from affected patients and families.
As The Orange County Register reports, Staci Simos and her husband, Michael Simos, filed suit in Los Angeles Superior Court against Olympus, claiming she acquired the CRE superbug after undergoing a procedure last October at UCLA with the company's Q180V duodenoscope. Simos says the outbreak infected her and at least 6 other patients, subsequently killing two individuals. The suit alleges product liability, negligence and fraud on the part of Olympus, and is also seeking unspecified damages, according to the OC Register story.
Olympus failed in its responsibilities to patients, as the company did not update its cleaning instructions for the device after it redesigned the product, according to the Simos suit. "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," the suit states (as quoted by the OC Register). And Olympus "failed to take these critical steps with the resigned Q180V scope."
But the company is standing by its product, saying it did not seek the FDA's approval for changes made to the device because it was not required under the agency's policy on modifications, Olympus spokesman Mark Miller said earlier this year.
The latest suit comes on the heels of more pushback, as patients and families affected by the outbreak continue to sue Olympus over contaminated duodenoscopes. Earlier this year, a 76-year-old man infected by the company's device filed a similar suit, claiming he suffered significant harm after undergoing a procedure with the device. A week before, the family of another patient exposed to bacteria from a dirty duodenoscope at UCLA sued the company for wrongful death, saying Olympus promoted the scope to maximize sales and profits at the expense of patients' safety.
The company is also facing backlash on another front, as the U.S. Department of Justice earlier this year subpoenaed the company to get more information about its duodenoscope devices. Olympus has largely stayed mum on the federal investigation and its civil lawsuits, but acknowledged last month in a regulatory filing that the legal action could take a toll on business.
Meanwhile, the FDA and UCLA Medical Center are taking steps to address the recent superbug outbreaks. UCLA officials have notified 179 patients who underwent endoscopic procedures between October and January that they may have been exposed to the superbug, the OC Register reports. Last month, an FDA panel recommended sterilizing the duodenoscope devices, rather than disinfecting them, to prevent future outbreaks. UCLA Medical Center has already adopted the method at its facilities.
- read the OC Register story