Olympus has been plagued with lawsuits and criminal investigations stemming from problems with its duodenoscopes for more than three years, but a plea agreement with the U.S. Department of Justice could help Olympus learn from its mistakes and move on.
The Tokyo, Japan-based company admitted that it failed to file adverse event reports involving infections that occurred in Europe in 2012 and 2013 that were associated with its TJF-Q180V duodenoscope. After pleading guilty to three criminal misdemeanors, the company was fined $80 million and ordered to forfeit $5 million. Olympus also agreed to undertake enhanced compliance measures as part of its plea agreement with the DOJ.
Hisao Yabe, a former executive based in Japan, also pleaded guilty to one count. He is scheduled to be sentenced March 27, 2019, and faces a maximum penalty of one year in prison. Yabe was the company's quality and environment division manager at the time that the infections occurred. Olympus first disclosed the DOJ investigation in May 2015.
Medical device manufacturers are required to file a medical device report (MDR) with FDA in a timely manner (generally within 30 days) after learning about an adverse event.
The investigation did not identify any direct harm to patients as a result of the disclosure failures, and Olympus said the settlement does not impact the availability of its products and services worldwide.
"Olympus deeply regrets its failure to file and supplement the MDRs identified in the plea agreement and accepts full responsibility for these failures," said Hiroyuki Sasa, president and representative director at Olympus.
The company said it has already made notable compliance improvements since these events occurred, such as enhancing reorganizing and enhancing its global regulatory affairs department, adding reporting and supervisory personnel, restructuring the organization to promote greater communication and accountability, and increasing training for personnel.
Separately, FDA issued a safety notice alerting hospitals to preliminary results of sampling studies that show duodenoscopes have a higher-than-expected contamination rate after reprocessing. Click here to read more about the findings.