Olympus (TYO:7733) said this month that the U.S. Justice Dept. subpoenaed a U.S. medical device subsidiary in March over deadly outbreaks of so-called “superbug” infections linked to endoscopes it makes.
In February and March duodenoscopes made by Olympus were implicated in dozens of hospital-acquired infections across the country. In Seattle, 39 people were infected at the Virginia Mason Medical Center between 2012 and 2014; 11 eventually died. All were critically ill when they were infected, but it was unclear if the bacterial infection contributed to their deaths, Seattle public health officials said at the time.
Four patients in March were infected with bacteria from a contaminated scope and 67 more were at risk at Cedars-Sinai Medical Center in Los Angeles, weeks after UCLA Ronald Reagan hospital reported 7 patients were similarly infected and scores more potentially exposed.
Across the country in Connecticut, Hartford Hospital reported a similar outbreak involving at least 5 infections and more than 280 potential exposures.
Between 2013 and 2014, the FDA said it received reports of 135 possible microbial transmission from reprocessed duodenoscopes. The federal safety watchdog is slated to convene a special meeting of its gastroenterology & urology devices panel May 14-15 to discuss the transmission of “superbug” infections through endoscopy procedures in U.S. hospitals.
In its annual report issued May 8, the Japanese conglomerate said the Justice Dept. subpoena “seeks information relating to duodenoscopes that Olympus manufactures and sells.”
“In addition, subsidiaries of Olympus have been named as defendants in civil lawsuits in the United States alleging that the plaintiffs were harmed as of our group’s duodenoscopes. Depending on the developments in these matters, our consolidated results of operations and financial condition may be affected,” the company said.
The DoJ probe also reportedly involves at least 1 of the hospitals affected by a superbug outbreak.
Rando Wick, an attorney representing Virginia Mason Medical Center, told the L.A. Times that the hospital received a subpoena about a month about Olympus and its duodenoscopes, seeking information dating back several years.
Prosecutors, led by Jacob Elberg, chief of the healthcare & government fraud unit at the U.S. attorney’s office in Newark, N.J., “are clearly focused on a full investigation of Olympus,” Wick said. “They are asking for a lot of information.”