Olympus Plea Agreement

Olympus has been plagued for more than three years by criminal prosecutions and investigations resulting from problems with its duodenoscopes, but a deal with the U.S. Department of Justice could help Olympus learn from its mistakes and keep going. On the day of the oral argument, the FDA issued a new safety notification to manufacturers and users, which it updated regarding an ongoing review of post-market duodenoscop surveillance studies, which found “higher than expected” contamination rates after reprocessing. The Agency asked them to closely follow manual cleaning, disinfection and sterilization procedures. The Tokyo, Japan-based company admitted that it had not provided reports of adverse events involving infections that occurred in Europe in 2012 and 2013 and were associated with its TJF-Q180V duodenosscope. After pleading guilty to three criminal offenses, the company was fined $80 million and sentenced to a loss of $5 million. Olympus has also agreed to take enhanced compliance measures as part of its Plea agreement with the DOJ. The confession of guilt is the culmination of an investigation by special agents of the FDA Office of Criminal Investigations, led by Special Investigator Jeffrey J. Ebersole of the New York Field Office, with special agents of the U.S. Department of Health, Office of Inspector General, under the direction of Charge Special Agent Scott J.

Lampert. and FBI special agents, under the direction of Special Agent Gregory W. Ehrie. The Tokyo-based company was fined $80 million and ordered to lose an additional $5 million under the Plea agreement, which included three federal offenses for distributing medical devices with a false brand indication, in accordance with the Food Act, medicines and cosmetics. Meanwhile, a former head of regulation of Japan`s top Olympus – Hisao Yabe, director of the company`s quality and environment department – has pleaded guilty to one count and could expect a year in prison after his conviction in March 2019. Olympus is also expected to carry out “significant compliance reforms” as part of the deal, according to the U.S. Department of Justice. Olympus Medical Systems has pleaded guilty to failing to file adverse event reports detailing serious infections related to its duodenoscopes, as requested by the FDA. In the agreement, Olympus acknowledged that it had not provided the U.S. Food and Drug Administration (FDA) with two additional MDRs needed and a first MDR for events in Europe between August 2012 and October 2014. The company has agreed to plead guilty to three crimes in U.S. District Court for New Jersey.

In addition, the company agreed to pay a fine and total loss of approximately $85 million, take further steps to improve its regulatory processes and procedures, and regularly perform certain certifications that the company meets the expectations of the comparison. . . .