Seattle's Virginia Mason Medical Center, the target of a lawsuit stemming from the death of a 57-year-old patient who was allegedly infected by a non-sterile duodenoscope, has joined with the patient's widow in suing Olympus America.
The patient, Richard Bigler, of Woodway, Wash., was one of 39 Virginia Mason patients who were infected by carbapenem-resistant Enterobacteriaceae (CRE) between 2012 and 2014, according to a report in the Seattle Times, which says at least 18 of those patients have died, though it's not clear whether any of the deaths were directly related to the infections.
The outbreak was one of several nationwide since 2010 that have been linked to duodenoscopes manufactured primarily by Olympus, but also by Pentax Medical and Fujifilm, according to the FDA. Duodenoscopes, which are notoriously challenging to clean, are used in hundreds of thousands of endoscopic retrograde cholangiopancreatography (ERCP) procedures annually. Olympus, which has by far the largest share of the duodenoscope market, recently issued new reprocessing instructions for its TJF-Q180V scope.
"Virginia Mason was misled and misinformed by Olympus as to the safety of its devices," John Gagliardi, a lawyer for widow Theresa Bigler, tells the Seattle Times. Evidence suggests that Olympus has known for years that its scopes could spread bacteria, he adds, but that it chose not to tell Virginia Mason or other facilities.
The latter accusation echoes a charge made in a Los Angeles Times report, which claims that Olympus warned hospitals in Europe as early as January 2013 that the scopes could pose an infection threat.
Virginia Mason's suit against the manufacturer is a cross claim in answer to Ms. Bigler's suit, which names Virginia Mason as a defendant, in addition to Olympus.
"We express our sympathy to the patients who have experienced infections and to their families," says an Olympus spokesman. "We are taking this matter extremely seriously. We do not normally comment on active legal matters, however 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."