• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    ENDRA Life Sciences Issued 27th Patent

    AI-Enabled SKOUT Device Improves Colorectal Cancer Screening

    Simon Johnson Appointed as Senior Business Development VP at MedAcuity

    Foster Corporation Named Marketing Partner for AdvanSource Biomaterials

    Researchers Develop New Apparatus for the Treatment of Cardiovascular Diseases
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Trademark Plastics Inc.

    Concise Engineering

    Cirtec Medical

    JBC Technologies

    Arthur G. Russell Co. Inc., The
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    ‘Right to Repair’: Separating Fact from Fiction

    Taking a Holistic Approach to Decentralized Clinical Trials (DCTs)

    Investment in Health Startups Drops

    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Trademark Plastics Inc.

    Concise Engineering

    Cirtec Medical

    JBC Technologies

    Arthur G. Russell Co. Inc., The
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time

    Olympus admitted that it failed to file with the FDA required adverse event reports in 2012 and 2013 relating to three separate infection events.

    Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time
    U.S. Department of Justice12.11.18
    Olympus Medical Systems Corporation and a former senior executive in Japan pleaded guilty in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes, and continuing to sell the duodenoscopes in the United States despite those failures, the Justice Department announced.
     
    Olympus, which is located in Tokyo, Japan, and Hisao Yabe, 62, of Japan, both entered guilty pleas before U.S. District Court Judge Stanley R. 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). 
     
    Judge Chesler also imposed sentence on the company—fining Olympus $80,000,000 and ordering $5,000,000 in criminal forfeiture, consistent with a plea agreement between Olympus and the Justice Department. Olympus must also abide by an agreement with the Justice Department requiring Olympus to enact extensive compliance reforms.
     
    Yabe is scheduled to be sentenced by Judge Chesler on March 27, 2019. Yabe faces a maximum potential penalty of a year in prison and a $100,000 fine, or twice the gain or loss from the offense.
     
    Olympus admitted that it failed to file with the Food and Drug Administration (FDA) required adverse event reports in 2012 and 2013 relating to three separate events involving infections in Europe connected to Olympus’s TJF-Q180V duodenoscope (Q180V): the infection of approximately 22 patients with Pseudomonas aeruginosa at the Erasmus Medical Center in the Netherlands in early 2012; the infection of three patients with Escherichia coli at Clinique de Bercy in France in November 2012; and the infection of five patients with Pseudomonas aeruginosa at Kremlin Bicetre in France in July 2012.
     
    Yabe admitted his own personal responsibility for the failure to file the necessary information with FDA relating to the Erasmus Medical Center infections. At the time, Yabe was Olympus’s Division Manager for the Quality and Environment Division—Olympus’s top regulatory official, whose responsibilities included adverse event reporting in the United States. 
     
    “Medical devices, such as the Olympus duodenoscope that is used in 500,000 procedures per year in the United States, can extend and improve the quality of life for many people,” said Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division. “But when a device manufacturer becomes aware of risks that could lead to illness, injury, or death, there is a statutory obligation to report that information to the FDA in a timely manner. By failing to do so, Olympus and Mr. Yabe put patients’ health at risk.”
     
    “Olympus and Yabe failed to file important FDA reports regarding adverse events,” Attorney for the United States Rachael Honig, District of New Jersey, said. “It is especially troubling that they remained quiet when they received additional information from an independent expert questioning the safety of Olympus’ device. Patient safety must always be a paramount concern for medical device companies, and these defendants simply failed to treat that concern with the gravity it deserves. The resolution is a reminder that this office will act whenever patient safety is put at risk by a quest for profits.”
     
    “Medical device adverse event reporting requirements are designed to protect Americans by providing FDA with a tool to detect potential safety issues. When device manufacturers fail to report adverse events, unsuspecting patients are placed at risk,” said FDA Commissioner Scott Gottlieb, M.D. “We take our patient safety mission very seriously and we remain fully committed to aggressively pursuing those who jeopardize public health by subverting FDA’s regulatory requirements.”
     
    Olympus’s and Yabe’s Failure to File Required Adverse Event Reports
    To enable FDA and others to identify and monitor adverse events, the FDCA requires medical device manufacturers to file adverse event reports—known as Medical Device Reports (MDRs)—when the manufacturer becomes aware of information that reasonably suggests that the manufacturer’s device may have caused or contributed to a death or serious injury. The FDCA also requires manufacturers to file supplemental MDRs if they subsequently obtain information about the event that was not known or available when the initial MDR was filed.
     
    Olympus admitted that it failed to make the required initial MDR filing regarding the Kremlin Bicetre infections, and failed to file required supplemental MDRs relating to the Erasmus Medical Center and Clinique de Bercy infections, for which Olympus had filed initial MDRs. Under the FDCA, devices for which required MDRs and supplemental MDRs have not been filed are deemed misbranded, and it is a crime to ship such devices in interstate commerce. Between August 2012 and October 2014, Olympus shipped hundreds of misbranded duodenoscopes in the United States, generating approximately $40 million in revenue and approximately $33 million in total gross profit. Olympus’s payment of $85 million is more than 2½ times Olympus’s total profit from sales of the misbranded duodenoscopes.
     
    Yabe admitted that he was aware of Olympus’s obligation to file supplemental MDRs and was involved in Olympus’s failure to file a supplemental MDR regarding the Erasmus Medical Center infections and a report Olympus received prepared by an independent expert of Delft University of Technology in the Netherlands. That expert report—which Olympus obtained in the summer of 2012—noted numerous problems with the Q180V, including that the Q180V’s tip had various cracks, corners, and crevices that could harbor bacteria and could be cleaned only with great difficulty. The report recommended immediate further investigation of all such scopes, updating the cleaning instructions, and improving the quality of the seals.
     
    Additional Compliance Measures
    As part of its plea agreement with the Justice Department, Olympus has agreed to: retain an independent MDR expert to inspect and review Olympus’s policies and procedures to determine their compliance with the MDR requirements of the FDCA and its implementing regulations; periodic review by the MDR expert of Olympus’s continued compliance with the MDR requirements of the FDCA and its implementing regulations; and conduct a review and audit of the device classification and market pathway for all endoscope device types manufactured by Olympus that are intended for use in the sterile body cavity and that are currently sold in the United States. The MDR expert will report back to FDA and the Justice Department periodically for three years. In addition, the President of Olympus and Olympus’s Board of Directors will periodically conduct a review of Olympus’s MDR compliance measures and classification/marketing pathway review and provide certifications to FDA and the Justice Department relating to those reviews. Olympus also is obligated to inform health care providers in the United States who received Q180Vs between August 2012 and October 2014 of Olympus’s plea, and to provide information to those health care providers regarding Olympus’s failure to file the required MDRs.
     
    In March 2016, Olympus Corp. of the Americas and Olympus Latin America, two separate subsidiaries of Olympus Corp., entered into deferred prosecution agreements (DPAs) and civil settlements with the U.S. Attorney’s Office for the District of New Jersey and the Justice Department’s Civil Division to resolve criminal and civil charges and civil claims relating to schemes between 2006-2011 to pay kickbacks to doctors and hospitals in the United States and violate the Foreign Corrupt Practices Act in Latin America. The DPAs are scheduled to expire in March 2019. While the unlawful conduct at issue in the resolution terminated in October 2014—a year and a half before the government entered into the DPAs—conduct relating to violations of the FDCA and failure to file MDRs was specifically not covered by the March 2016 resolution, as the investigation into the FDCA violations was ongoing at that time.
     
    The guilty pleas are the culmination of an investigation conducted by special agents from FDA’s Office of Criminal Investigations, under the direction of Special Agent in Charge Jeffrey J. Ebersole of the New York Field Office, along with special agents from the U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Scott J. Lampert, and special agents of the FBI, under the direction of Special Agent in Charge Gregory W. Ehrie.
     
    The government is represented in the criminal case by Assistant U.S. Attorneys Jacob T. Elberg and R. David Walk, Jr. of the U.S. Attorney’s Office’s Health Care and Government Fraud Unit, and Senior Litigation Counsel Patrick Jasperse of the Justice Department’s Consumer Protection Branch, with the assistance of Senior Counsel Shannon M. Singleton of the FDA’s Office of Chief Counsel.
    Related Searches
    • corporation
    • mr
    • company
    • bacteria
    Related Knowledge Center
    • Surgical
    Loading, Please Wait..

    Trending
    • Siemens Healthineers & The Ohio State University Wexner Medical Center Enter Strategic Partnership
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • How To Overcome The Top 6 Medical Device Manufacturing Challenges
    • ‘Right To Repair’: Separating Fact From Fiction
    • The Future Of Biomedical Engineering Advancements
    Breaking News
    • ENDRA Life Sciences Issued 27th Patent
    • AI-Enabled SKOUT Device Improves Colorectal Cancer Screening
    • Simon Johnson Appointed as Senior Business Development VP at MedAcuity
    • Foster Corporation Named Marketing Partner for AdvanSource Biomaterials
    • Researchers Develop New Apparatus for the Treatment of Cardiovascular Diseases
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Pharmavite Expands in Ohio with $200 Million Investment
    Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company
    Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products
    Coatings World

    Latest Breaking News From Coatings World

    Clariant’s Launches Dispersogen Flex 100
    Lincoln Tech Enters Partnership with AkzoNobel
    AkzoNobel Launches International Interzone 945GF
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    ENDRA Life Sciences Issued 27th Patent
    AI-Enabled SKOUT Device Improves Colorectal Cancer Screening
    Simon Johnson Appointed as Senior Business Development VP at MedAcuity
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Takeda to Expand U.S. Footprint
    Croda Pharma's Lipid Systems Capability to Support mRNA Vaccines
    WuXi STA Opens High-Potency API Plant
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Latest Updates About Cosmoprof North America
    Meet the Clean Beauty Brand for Dogs
    Paco Rabanne Introduces Elle Fanning as Ambassador for New ‘Fame’ Fragrance
    Happi

    Latest Breaking News From Happi

    Two-Part Skincare Product Patented by Estée Lauder Companies
    American Cleaning Institute Pens Letter to Congress Encouraging Examination of Recyclability Improvements
    The Expert Panel for Fragrance Safety Celebrates 55 Years
    Ink World

    Latest Breaking News From Ink World

    INX Launches INXFlex Contour for Shrink Sleeve Market
    Xerox Announces Unexpected Passing of Vice Chairman and CEO John Visentin
    MNYPIA Golf Outing Set to Tee Off on Aug. 17
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Meyers purchased by third generation of Dillon family
    Epson now shipping ColorWorks C4000 inkjet label printer
    Nobelus launches new films for prime labels
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    What You’re Reading on Nonwovens-Industry.com
    Daio, Livedo Partner to Recycle Diapers
    Suominen Launches Hydraspun Reserve
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    3D Systems and EMS-GRILTECH Enter Strategic Partnership
    AIP Researchers Develop Microfluidic-Based Soft Robotic Prosthetic
    David Sharp Named Global Marketing VP at Catalyst OrthoScience
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Impinj Launches E910 RFID Reader Chip for Next Generation Enterprise IoT
    onsemi Receives Recognition for Sustainability for Third Straight Year
    Xerox Announces the Unexpected Passing of Vice Chairman and CEO John Visentin

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login