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Olympus received a subpoena from the US Department of Justice in March in relation to the company's duodenoscopes, according to a recent regulatory filing. Specifically, the subpoena, which was issued to Olympus Medical Systems, "seeks information relating to duodenoscopes that Olympus manufactures and sells." Olympus noted that it was required to acknowledge the subpoena as it may have future financial implications, while company spokesman Mark Miller said Olympus could not comment on active investigations.
Duodenoscopes, which are also made by Pentax and Fuji, have been linked to outbreaks of drug-resistant bacteria at hospitals in Los Angeles, Seattle, Philadelphia, Chicago, and Florida, among other places. In February, Olympus was sued by a patient who accused the company of negligence for selling duodenoscopes prone to spreading bacteria, in the first lawsuit stemming from the outbreak of drug-resistant bacteria at the University of California at Los Angeles hospital that killed at least two people. The following month, the FDA noted that Olympus issued new cleaning guidelines to hospitals regarding its TJF-Q180V duodenoscope. The US agency recently said 142 reports related to contaminated duodenoscopes and possible patient infections have been received since 2010.
The Department of Justice declined to comment on the subpoena, the nature of the investigation, or whether it is a civil or criminal matter. A department spokesman did not indicate whether subpoenas have also been sent to Pentax and Fuji. Pentax commented that "our practice is not to confirm or deny the existence of governmental inquiries,"while a Fuji spokesman did not comment.
Olympus recently disclosed that it recorded an extraordinary loss of approximately 53.9 billion yen ($437 million) for the fiscal year ended March 2015 in relation to an ongoing investigation by the Department of Justice into its medical business. While the company did not reveal the details of what products are involved, it said the probe, which began in November 2011, is looking into possible violations of anti-kickback and false claims laws by the company's US subsidiary.
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