Olympus fined $85 million in duodenoscope case; former exec faces prison

(Photo by rawpixel on Unsplash) Olympus (TYO:7733) and a former senior executive in Japan have pleaded guilty in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes, and to continuing to sell the devices in the United States despite those failures, the Justice Department announced.   Tokyo-based Olympus and Hisao Yabe, 62, both entered guilty pleas before U.S. District Court Judge Stanley Chesler in Newark Federal Court: Olympus to three counts, and Yabe to one count, of distributing misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Olympus has been mired in legal trouble over its duodenoscopes, devices that were designed to be re-used once cleaned or reprocessed by a healthcare facility. The scopes proved difficult to clean and have been implicated in superbug outbreaks in the U.S. and Europe. A judge last year ordered Olympus to pay $6.6 million to Virginia Mason Medical Center (Seattle, Wash.) where patient Richard Bigler died in 2013 after contracting an infection from a contaminated duodenoscope. The company was also ordered to  pay $1 million to Bigler’s family. The jury in that case found that the duodenoscope was not unsafe. In January 2018, a judge ordered a new trial in the Bigler case, saying the company failed to properly disclose internal emails that questioned a redesigned scope’s safety as early as 2008, according to the ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Business/Financial News Food & Drug Administration (FDA) Legal News Olympus Source Type: news