Olympus subpoenaed over device linked to superbugs
The U.S. Justice Department has subpoenaed a subsidiary of Olympus Corp. regarding an endoscope linked to the transmission of deadly "superbugs" resistant to multiple antibiotics.
The U.S. Justice Department has subpoenaed a subsidiary of Olympus Corp. regarding an endoscope linked to the transmission of deadly "superbugs" resistant to multiple antibiotics.
Olympus, which has U.S. headquarters in Center Valley, Pa., disclosed the subpoena this month in a statement of its financial results for the fiscal year that ended March 31.
The company also disclosed it had set aside 58.9 billion yen - more than $475 million at current exchange rates - for potential settlement of Justice Department claims under the "antikickback" statute. The department began that investigation in November 2011, according to the statement.
The company declined to comment on these disclosures beyond its financial statement.
The endoscope in question is a duodenoscope, used to examine and treat problems in the bile and pancreatic ducts. The Food and Drug Administration warned hospitals this year that those devices may harbor bacteria even when hospitals follow all of the recommended steps for cleaning.
Last week, USA Today reported that an infection-control expert at the federal Centers for Disease Control and Prevention warned the FDA of problems with the devices in 2009. Other manufacturers of these scopes include Fujifilm and Pentax Medical.
Drug-resistant infections have been linked to the scopes at hospitals in Los Angeles, Seattle, and a Chicago suburb, among other locations.
The federal inquiry seems to be extensive, said Rando Wick, an attorney representing the Seattle hospital, Virginia Mason Medical Center, and "is seeking information about what Olympus knew and when."
The Justice Department has contacted Virginia Mason seeking information about the Olympus scopes, and the hospital is cooperating, he said. The hospital also has joined a lawsuit against Olympus filed by the widow of a patient who died of a superbug infection.
In Philadelphia, Thomas Jefferson University Hospital identified such infections in eight patients who had been treated with a duodenoscope in 2013 and 2014, but said it found no proof that the scopes were to blame.
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