Olympus Medical Systems Corporation (Olympus) and a former executive in Japan pleaded guilty today in Newark, New Jersey, failed to submit necessary adverse event reports on duodeoscope-related infections and continued to sell duodenoscopes in the United States despite these errors, as announced today by the Department of Justice. On the day of the submissions, the FDA issued a new safety communication to manufacturers and users, who updated it following an ongoing review of post-market duodenoscope surveillance studies that found “higher contamination rates” after reprocessing. The Agency asked them to closely monitor manual cleaning, disinfection and sterilization procedures. Olympus, which is headquartered in Tokyo, Japan, and Hisao Yabe, 62, of Japan, both guilty pleas in U.S. District Court Judge Stanley R. Chesler in Newark Federal Court: Olympus to three counts, and Yabe to one point, distributing medical devices improperly stigmatized in interstate commerce in violation of the Federal Food, Drug, Cosmetic and Act (FDCA). As part of its advocacy agreement with the Department of Justice, Olympus has agreed to retain an independent MDR expert to review Olympus` guidelines and procedures and to verify whether they meet the FDCA`s MDR requirements and how it is applied; regularly audited by the MDR expert of Olympus` continued compliance with the FDCA`s MDR requirements and how it was applied; and verify and verify the classification and route of the market for all types of endoscopic devices manufactured by Olympus, intended for use in the sterile cavity and currently sold in the United States. The MDR expert will report regularly to the FDA and the Department of Justice for three years. In addition, the President of Olympus and the Olympus Board of Directors will conduct a regular review of Olympus` MDR compliance measures and classification/marketing trajectory verification and provide certifications to the FDA and the Department of Justice for these audits. Olympus is also required to inform U.S. health care providers who received q180Vs between August 2012 and October 2014 from Olympus` advocacy today and to provide these health care providers with information about Olympus` inability to submit the necessary MrRs. The Tokyo, Japan-based company acknowledged that it had not submitted reports of adverse events regarding infections that appeared in Europe in 2012 and 2013 and associated with its duodenoscope TJF-Q180V.
After pleading guilty to three criminal offences, the company was fined $80 million and ordered to forfeit $5 million. Olympus also expressed its readiness to take enhanced compliance measures as part of its appeal agreement with the DOJ. Olympus has been plagued by lawsuits and criminal investigations for more than three years due to problems with its duodenoscopes, but a plea with the U.S. Department of Justice could help Olympus learn from its mistakes and continue. The guilty pleas are the culmination of an investigation by special investigators from the FDA`s Bureau of Criminal Investigations, led by Special Agent Jeffrey J. Ebersole of the New York Land Office, as well as special agents from the U.S. Department of Health, the Office of Inspectors General, under the direction of Special Envoy Scott J. Lampert and special agents of the FBI.