Statement on $147M Verdict for AMDR Member Innovative Health Against Johnson & Johnson’s Biosense Webster Medical Technology Unit
The Association of Medical Device Reprocessors (AMDR) has issued a statement following a unanimous federal jury verdict in Santa Ana, California, in favor of Innovative Health against Johnson & Johnson’s Biosense Webster medical technology unit. The jury found that Biosense Webster violated federal and state antitrust laws by withholding clinical support to hospitals using Innovative Health’s FDA-regulated, reprocessed catheters.
The verdict sends a clear message to medical device manufacturers that hospitals have the right to choose lower-cost, more environmentally friendly, FDA-regulated reprocessed alternatives. “For too long, Johnson & Johnson has used tying arrangements and other tactics to interfere with fair competition from lower-cost, FDA-regulated, reprocessed ‘single-use’ devices (SUDs),” said Daniel J. Vukelich, President and CEO of AMDR. “We hope this jury’s 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).”
Reprocessed SUDs are domestic devices that make hospitals stronger by reducing costs, waste, and greenhouse gas emissions. They also help address supply chain resilience issues highlighted by COVID-19 and potentially exacerbated by tariffs. The use of reprocessed SUDs is a significant step towards hospital sustainability and supply chain robustness.
Proactive Steps for Hospitals to Combat OEM Anti-Reprocessing Tactics
- Document and escalate any OEM threats to void warranties or withdraw support for using FDA-regulated reprocessed SUDs.
- Require written hospital approval before any OEM software upgrade is installed to protect against unapproved updates that disable reprocessed devices.
- Bar OEMs from using embedded chips or ePROM programming that disables reprocessed devices or shortens their lifespan.
- Refuse contract clauses that restrict reprocessing or condition “free” equipment on exclusive use of new SUDs.
- Track SKU pricing over time and across vendors to identify price gouging on reprocessable models.
- Ban practices that sabotage hospital inventory, such as replacing cables without permission or hiding reprocessed-device bins.
- Suspend access for sales reps who circulate misleading “dirty device” studies, especially those funded by OEMs.
AMDR is conferring with its members and considering legal options to push back against anti-reprocessing tactics by OEMs. The association advocates for reprocessing and remanufacturing as crucial healthcare strategies that help hospitals strengthen their supply chain while reducing costs, waste, and emissions.
About AMDR: The Association of Medical Device Reprocessors is the global trade association for the regulated commercial ‘single-use’ device reprocessing and remanufacturing industry. AMDR members serve over 9,400 hospitals and surgical centers worldwide. Founded in 1997, AMDR protects its members’ interests in regulation, legislation, and standard-setting, pushing for the global medical technology industry to adopt remanufacturing as a defining aspect of new device technologies.
