Hospital joins lawsuit against maker of duodenoscopes

Official says failing disclose the device's risks was 'unethical'

Virginia Mason Medical Center (VMMC) in Seattle has joined a lawsuit against Olympus America, claiming that the devicemaker put patients at risk by failing to disclose design flaws in endoscopy scopes that contributed to superbug infections at the hospital and several others.  

FDA issues warning on endoscopes linked to superbug outbreaks

Background on the superbug outbreaks

According to VMMC, the scopes sickened 39 patients after being exposed to strains of multidrug-resistant E. coli through tainted Olympus duodenoscopes between 2012 and 2014—even though the hospital had followed official cleaning procedures for the devices. At least 11 of those patients died, but it is unclear what other factors may have caused their deaths.

VMMC is not the only hospital to report superbug outbreaks linked to the devices.

As many as 179 patients could have been exposed to carbapenem-resistant Enterobacteriaceae (CRE) after having an endoscopic retrograde cholangiopancreatography at UCLA's Ronald Reagan Medical Center between October 2014 and January 2015. Seven patients were confirmed to have CRE infections, and two of those patients died.

Meanwhile, Cedars-Sinai Medical Center in Los Angeles in March reported that four patients had been infected with CRE and up to 67 more might have been exposed after being treated with the duodenoscopes.

Last week, FDA revealed that it had received 142 adverse event reports between 2010 and Feb. 17, 2015, on patient harm from duodenoscopes. However, the agency says that duodenoscopes serve an important purpose in treating patients and should not be recalled.

Details of the lawsuit

In March, Theresa Bigler, the wife of a patient who died at VMMC, filed a lawsuit against Olympus, claiming the faulty scopes were the cause of her husband's death. On Monday, VMMC announced that it would join the suit.

Andrew Ross, the head of gastroenterology at VMMC, says the hospital was misled about the risk to patients. "Olympus failed to inform our organization about this safety risk associated with its product," he says, adding, "their silence on this important issue was unethical, irresponsible, and put patient lives at risk."

Endoscope maker warned Europe years before U.S. superbug outbreaks

Olympus spokesperson Mark Miller says the company is taking the issue "extremely seriously." He explains, "We are continuing our investigation into the reports at Virginia Mason to be able to provide a more thorough and balanced perspective on the issues including potential causes of the infections."

Miller adds that the company is working with FDA and other regulators to "enhance safeguards" against superbug infections linked to its scopes (Cavaliere, Reuters, 5/12; Terhune, Los Angeles Times, 5/12; Aleccia, Seattle Times, 5/11).

The takeaway: Virginia Mason Medical Center is joining a lawsuit against Olympus America, claiming the company's endoscopes were dangerous to patients and the company did not discloses all associated risks.


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