Pentax, FujiFilm receive US Department of Justice subpoenas over duodenoscopes: report

According to sources familiar with the investigation, Pentax and FujiFilm recently received subpoenas from the US Department of Justice in relation to the companies' duodenoscopes, USA Today reported Thursday. The report follows a recent disclosure from Olympus that the company received a subpoena from the Department of Justice in March.

The Department of Justice did not confirm the existence of the investigation, while Pentax, FujiFilm and Olympus did not comment on the matter.

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 an outbreak of drug-resistant bacteria at a University of California at Los Angeles (UCLA) hospital. The FDA noted in March that Olympus issued new cleaning guidelines to hospitals regarding its TJF-Q180V duodenoscope. Last month, the regulator said 142 reports related to contaminated duodenoscopes and possible patient infections have been received since 2010, and an FDA advisory panel recommended intensified cleaning steps for duodenoscopes, with several group members suggesting mandatory sterilisation of the devices before they are reused.

According to USA Today, a subpoena was also delivered to Virginia Mason Hospital, Seattle, which experienced one of the largest outbreaks of antibiotic-resistant bacterial infections linked to contaminated duodenoscopes. Other hospitals that have had outbreaks of duodenoscope-related infections, including UCLA Medical Center, Los Angeles, Advocate Lutheran Hospital, Chicago and the University of Pittsburgh Medical Center, said they have not been subpoenaed.

According to USA Today, while the subpoenas do not detail the exact nature of the investigation, the order sent to Virginia Mason Hospital relates to healthcare offenses as defined in federal criminal statutes. Rando Wick, a lawyer representing Virginia Mason Hospital, noted the supervising attorneys "certainly are casting their net widely in terms of what kind of documents they're seeking." Wick said the Virginia Mason Hospital order seeks records related to when Olympus learned that its duodenoscopes were implicated in a 2013 outbreak of drug-resistant bacteria at the hospital and how the device maker responded to the incident. Wick added "they want not only our communications with Olympus, but with the FDA, the Centers for Disease Control and Prevention, and state and local health authorities."

Did you like this article?