On the day the pleas were submitted, the FDA issued a new safety advisory to manufacturers and users informing them of an ongoing review of post-market duodenoscope monitoring studies that revealed “higher than expected contamination rates” after reprocessing. The agency urged them to strictly follow manual cleaning, disinfection and sterilization procedures. TOKYO, Japan (December 10, 2018) – Olympus Medical Systems Corporation (OMSC), a subsidiary of Olympus Corporation, today entered into an agreement with the U.S. Department of Justice (DOJ) on matters related to the submission and addition of medical device reports (MDRs) for Olympus TJF-Q180V duodenoscopes. The Justice Department`s investigation was first published by the company in May 2015. Olympus Medical Systems Corp. (Olympus) and Hisao Yabe, a former quality manager, pleaded guilty to failing to submit the required medical device (adverse event) (MDR) reports with duodenoscope-related infections and distributing mislabeled medical devices to interstate commerce, in violation of the Food, Drugs and Cosmetics Act (FDCA). Under the terms of the agreement, Olympus will pay $80 million in fines and $5 million in criminal forfeiture to the U.S. Department of Justice (DOJ) and implement significant compliance reforms. In addition, a former Olympus regulatory officer in Japan – Hisao Yabe, director of the company`s quality and environment department – has pleaded guilty to one count and could face up to a year in prison if convicted in March 2019. Olympus must also implement “extensive compliance reforms” as part of the deal, according to the U.S.
Department of Justice. The Tokyo-based company was fined $80 million and forfeited an additional $5 million under the deal, which included three federal offenses for distributing mislabeled medical devices under the Food, Drugs and Cosmetics Act. “Olympus deeply regrets having submitted and completed the [medical device reports] identified in the agreement and assumes full responsibility for these omissions. Hiroyuki Sasa, president and deputy director of Olympus` largest parent company, said in a statement. Sasa previously served as General Manager of the company`s Endoscope Business Planning Department in the early 2000s and then as Executive Director and Director of Olympus Medical. Olympus, which is located in Tokyo, Japan, and Hisao Yabe, 62, of Japan, both pleaded before U.S. District Judge Stanley R. Chesler in Newark Federal Court: Olympus on three counts and Yabe for distributing mislabeled medical devices in interstate commerce in violation of federal food law, medicines and cosmetics (FDCA). As of March 2016, Olympus Corp. of the Americas and Olympus Latin America, two separate subsidiaries of Olympus Corp., have entered into deferred prosecution agreements (DPAs) and civil settlements with the U.S. Attorney`s Office for the District of New Jersey and the Civil Division of the Department of Justice to prosecute criminal and civil charges and civil lawsuits related to plans between 2006 and 2011 to pay bribes to doctors and hospitals in the United States and violate foreign corrupt practices. Trade in Latin America.
DPAs are expected to expire in March 2019. Although the illegal conduct at issue in today`s resolution ended in October 2014 – a year and a half before the government entered the DPAs – the conduct regarding the FDCA violations and MDR`s non-submission was explicitly not covered by the March 2016 resolution, as the investigation into the FDCA violations was not yet completed at that time. The guilty pleas are the culmination of an investigation by special agents from the FDA`s BUREAU of Criminal Investigations, led by Special Agent Jeffrey J. Ebersole of the New York office, as well as special agents from the U.S. Department of Health and Human Services, Office of the Inspector General, led by Special Agent in charge Scott J. Lampert. and FBI special agents under the direction of Special Agent Gregory W. Ehrie. As part of its agreement with the Department of Justice, Olympus has committed to: engage an independent MDR expert to review and review Olympus` policies and procedures to determine whether they comply with the FDCA`s MDR requirements and regulations; a regular review by Olympus of the MDR expert`s continued compliance with the FDFA`s MDR requirements and implementing regulations; and conduct a review and examination of device classification and market trajectory for all types of endoscopes manufactured by Olympus for use in the sterile body 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 periodically conduct a review of Olympus` MDR compliance measures and review of classification/marketing pathway, and submit certifications to the FDA and the Department of Justice in connection with these reviews.
Olympus is also required to notify healthcare providers in the United States who received Q180V between August 2012 and October 2014 of Olympus` lawsuit today and to inform such healthcare providers that Olympus has not filed the required MDRs. In this week`s decision, Chesler also fined Olympus $80 million and ordered a $5 million criminal forfeiture, which is in line with an agreement between Olympus and the Justice Department. Olympus must also abide by an agreement with the Ministry of Justice that requires Olympus to carry out extensive compliance reforms. Yabe is expected to be convicted by Chesler on March 27, 2019. Yabe faces a potential maximum sentence of one year in prison and a fine of $100,000, double the profit or loss of the offense. Olympus Medical Systems Corporation (Olympus) and a former senior executive in Japan pleaded guilty today in Newark, New Jersey, to failing to file the required adverse event reports related to duodenoscope-related infections and continuing to sell the duodenoscopes in the United States despite these errors, the Department of Justice announced today. Olympus Medical Systems has pleaded guilty to failing to submit adverse event reports listing serious infections related to its duodenoscopes, as required by the FDA. As part of its agreement, Olympus agreed to the following: Justice Chesler also fined the company today – he fined Olympus $80,000,000 and ordered a $5,000,000 criminal forfeiture, which is consistent with an agreement between Olympus and the Department of Justice. Olympus must also abide by an agreement with the Ministry of Justice that requires Olympus to carry out extensive compliance reforms. U.S. District Judge Stanley R.
Chesler imposed the fine — an $80 million fine and $5 million in criminal forfeiture — on Olympus after the company pleaded guilty Monday in Newark to three counts of distributing mislabeled medical devices in interstate commerce, in violation of federal food law, medicines and cosmetics…