Olympus, the Japan-based manufacturer of medical scopes linked to the spread of deadly pathogens at U.S. hospitals, received a subpoena about the devices from the Department of Justice in March, according to disclosures made by the company in a regulatory filing earlier this month.
The subpoena issued to a subsidiary, Olympus Medical Systems, "seeks information relating to duodenoscopes that Olympus manufactures and sells," the company disclosed to shareholders in a filing on May 8. The subpoena from the Justice Department has not been previously reported. Olympus spokesman Mark Miller said in an email that the company couldn't comment on active investigations. The DOJ did not immediately respond to a request for comment.
Olympus is the leading manufacturer of duodenoscopes, which are used to diagnose and treat ailments in tiny ducts connected to the small intestine. Similar devices are also made by Pentax and Fuji. Duodenoscopes have proven difficult to clean and have been tied to outbreaks of drug-resistant superbugs at hospitals in Los Angeles, Seattle, Philadelphia, Chicago, and Florida, among other places. Days after the disclosure of the subpoena, a separate scientific panel convened by the U.S. Food and Drug Administration concluded that the devices lack a "reasonable assurance of safety and efficacy."
Olympus has been under investigation by the Justice Department over possible violations of anti-kickback and false-claims laws since 2011, according to previous disclosures made by the company. Settlement talks started last year, as Bloomberg News reported in February, and the company has already set aside $450 million for a potential settlement, according to a report Wednesday in the Los Angeles Times.
An accounting scandal at Olympus that came to light in 2011 resulted in a guilty plea by the company's former chairman, Tsuyoshi Kikukawa, who admitted covering up losses for 13 years starting in the 1990s.