{"id":61280,"date":"2025-05-19T01:02:43","date_gmt":"2025-05-18T23:02:43","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/statement-on-147m-verdict-for-amdr-member-innovative-health-against-johnson-johnsons-biosense-webster-medical-technology-unit\/"},"modified":"2025-05-19T01:02:43","modified_gmt":"2025-05-18T23:02:43","slug":"statement-on-147m-verdict-for-amdr-member-innovative-health-against-johnson-johnsons-biosense-webster-medical-technology-unit","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/statement-on-147m-verdict-for-amdr-member-innovative-health-against-johnson-johnsons-biosense-webster-medical-technology-unit\/","title":{"rendered":"Statement On $147M Verdict for AMDR Member Innovative Health Against Johnson & Johnson\u2019s Biosense Webster Medical Technology Unit"},"content":{"rendered":"
\n

WASHINGTON & BERLIN–(BUSINESS WIRE)–Association of Medical Device Reprocessors issued the following statement:\n<\/p>\n

<\/a>
<\/a><\/p>\n

\nFriday\u2019s unanimous verdict<\/a> by a federal jury in Santa Ana, California for Innovative Health against Johnson & Johnson (NYSE: JNJ<\/a>) is a victory for America\u2019s hospitals, providers, patients, and the environment. The jury found that Biosense Webster violated federal and state antitrust laws by withholding clinical support to hospitals using Innovative Health\u2019s FDA regulated, reprocessed catheters.\n<\/p>\n

\n\u201cFor too long, Johnson & Johnson has used tying arrangements and other tactics to interfere with fair competition from lower cost, FDA regulated, reprocessed \u2018single-use\u2019 devices (SUDs),\u201d said Daniel J. Vukelich, President and CEO, Association of Medical Device Reprocessors. \u201cWe hope this jury\u2019s message will be heard loud and clear: hospitals want to reduce costs and greenhouse gas emissions by using more reprocessed SUDs without fear of retribution by their original equipment manufacturers (OEMs).\u201d\n<\/p>\n

\nReprocessed SUDs are domestic devices, and domestic devices make hospitals stronger<\/span><\/b>\n<\/p>\n

\nBy having the freedom to choose FDA regulated reprocessed SUDs, hospitals reduce costs, waste, and greenhouse gas emissions. When using reprocessed SUDs, hospitals also help address supply chain resilience issues that were illuminated by COVID and could be made worse by tariffs.\n<\/p>\n

\nHow to Stop OEM Anti-Reprocessing Tactics: Proactive Steps for Hospitals<\/span><\/b>\n<\/p>\n

\nFor decades, AMDR and its member companies have reported potentially anticompetitive market manipulation tactics by some OEMs. This case brings these tactics under closer examination. Hospitals, particularly procurement staff, should pay close attention to these activities and take proactive steps to combat them.\n<\/p>\n

    \n
  1. \nThreats to void warranties or case support<\/b>
    OEMs cannot lawfully revoke support, void warranties, withdraw service, or otherwise retaliate for using FDA-regulated reprocessed SUDs. Make it policy to document and escalate any such threat and remind sales reps this activity is illegal and will not be tolerated.\n<\/li>\n
  2. \nUnapproved software updates that disable reprocessed devices<\/b>
    Protect your consoles and generators: require written hospital approval before any OEM software upgrade is installed. Explicitly deny updates that \u201cjust happen\u201d to block reprocessed devices or force obsolescence, and audit firmware versions after service visits.\n<\/li>\n
  3. \n\u201cChipping\u201d or ePROMs that brick reprocessed devices<\/b>
    Bar OEMs that use embedded chips or ePROM programming that disable reprocessed devices or shortens their life. Require advance disclosure of any device-identification or authentication features, make chip-based lock-outs a breach of contract, and reject products that rely on forced-obsolescence coding.\n<\/li>\n
  4. \nContract clauses that restrict reprocessing<\/b>
    When negotiating contracts, particularly those including volume-based discounts, calculate the hidden cost of losing reprocessing savings. Refuse language that conditions \u201cfree\u201d equipment or discounts on exclusive use of new SUDs and run all proposals past legal\/procurement for anti-competitive red flags.\n<\/li>\n
  5. \nPrice gouging on the \u201creprocessable\u201d model<\/b>
    Track SKU pricing over time and across vendors. If an OEM inflates the price of its reprocessable version to steer you to a non-reprocessable device, document it consider switching suppliers.\n<\/li>\n
  6. \nInterference with hospital assets<\/b>
    Ban any practice that sabotages your inventory: replacing cables without permission, hiding or discarding reprocessed-device bins, rearranging stock to favor new SUDs, or instructing clinicians to destroy hospital property. Treat such actions as asset tampering and revoke vendor access privileges immediately.\n<\/li>\n
  7. \nPublication or use of misleading \u201cdirty device\u201d studies<\/b>
    If a rep circulates OEM-funded studies, especially any that have been retracted or flagged for bias, suspend their access pending a formal review, and share the incident with infection-control and value-analysis committees.\n<\/li>\n<\/ol>\n

    \nAdopt these guardrails as formal policy, train staff to spot violations, and remind OEM partners that the rules of engagement have changed \u2013 hospitals will no longer put up with anti-reprocessing sabotage.\n<\/p>\n

    \nAMDR is conferring with its members, and considering legal options, to push back forcefully against behaviors like those described above and identified in Innovative Health, LLC v. Biosense Webster, Inc.<\/i>\n<\/p>\n

    \nAbout AMDR<\/b>\n<\/p>\n

    \nThe Association of Medical Device Reprocessors (AMDR) is the global trade association for the regulated, commercial \u201csingle-use\u201d device reprocessing and remanufacturing industry. AMDR members serve over 9,400 hospitals and surgical centers in the U.S., Canada, Europe, Japan and Australia.\n<\/p>\n

    \nFounded in 1997, AMDR advocates for reprocessing and remanufacturing as an important healthcare strategy that helps hospitals and healthcare providers to strengthen the supply chain while simultaneously reducing costs, waste, and emissions. AMDR protects the interests of its members in regulation, legislation, and standard-setting.\n<\/p>\n

    \nAMDR protects the interests of its members in regulation, legislation, and standard-setting. AMDR members include Arjo ReNu Medica<\/a>l<\/a>, Innovative Healt<\/a>h<\/a>, Medline Renewa<\/a>l<\/a>, Stryker\u2019s Sustainability Solutions<\/a>, Sustainable Technologie<\/a>s<\/a> (a Cardinal Health Business), and Vanguard A<\/a>G<\/a>. Having played a key role in the establishment of the reprocessing industry, AMDR continues to push the global medical technology industry, leading the way for remanufacturing to play a defining role in the evolution of new device technologies.\n<\/p>\n

    Contacts<\/b> <\/p>\n

    \nDavid Sheon
    \n
    VP External Affairs
    \n
    202-422-6999
    \n
    dsheon@amdr.org<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    WASHINGTON & BERLIN–(BUSINESS WIRE)–Association of Medical Device Reprocessors issued the following statement: Friday\u2019s unanimous verdict by a federal jury in Santa Ana, California for Innovative Health against Johnson & Johnson (NYSE: JNJ) is a victory for America\u2019s hospitals, providers, patients, and the environment. The jury found that Biosense Webster violated federal and state antitrust laws … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61280","6":"format-standard","7":"category-industry"},"yoast_head":"\nStatement On $147M Verdict for AMDR Member Innovative Health Against Johnson & Johnson\u2019s Biosense Webster Medical Technology Unit - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/statement-on-147m-verdict-for-amdr-member-innovative-health-against-johnson-johnsons-biosense-webster-medical-technology-unit\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Statement On $147M Verdict for AMDR Member Innovative Health Against Johnson & Johnson\u2019s Biosense Webster Medical Technology Unit - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"WASHINGTON & BERLIN–(BUSINESS WIRE)–Association of Medical Device Reprocessors issued the following statement: Friday\u2019s unanimous verdict by a federal jury in Santa Ana, California for Innovative Health against Johnson & Johnson (NYSE: JNJ) is a victory for America\u2019s hospitals, providers, patients, and the environment. 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