Virginia Mason Medical Center in Seattle has joined a lawsuit against Olympus America, claiming the device maker put patients at risk by failing to disclose design flaws in ERCP duodenoscopes suspected of passing the CRE superbug in several recent outbreaks.
What’s the Problem?
From 2012 to 2014, at least 39 patients at Virginia Mason Medical Center were sickened by drug-resistant strains of E.coli bacteria, 11 of whom died, according to the Advisory Board. The facility identified duodenoscopes made by Olympus America as the likely source of contamination.
Richard Bigler was among those who died of a bacterial infection caused by an Olympus duodenoscope, according to a lawsuit filed on behalf of his widow. In a rare move for a hospital, Virginia Mason joined Bigler’s lawsuit on May 11.
Virginia Mason denies any wrongdoing in Bigler’s death, saying Olympus failed to disclose the instrument’s design flaws or tell the facility its reprocessing instructions were inadequate. The complaint alleges that Olympus knew of the problems with the duodenoscope and issued warnings in Europe, but failed to do the same in the U.S.
“Olympus failed to inform our organization about this safety risk associated with its product,” said Andrew Ross, head of gastroenterology at Virginia Mason. “Their silence on this important issue was unethical, irresponsible, and put patient lives at risk.”
Feds Expand Investigation into CRE Superbug Outbreaks
June 9 – The Justice Department is seeking thousands of documents from duodenoscope manufacturers Olympus, Pentax and FujiFilm, according to USA TODAY.The subpoenas do not reveal specifically what’s being investigated; however, a document sent last month to Virginia Mason relates to healthcare violations as defined in federal criminal statutes.