Hotline goes beyond lawsuit and Johnson & Johnson MedTech to monitor and report anti-reprocessing activities

In May 2025, a jury returned a unanimous verdict in Innovative Health’s favor on all counts presented at trial, finding that Johnson & Johnson MedTech violated federal and California antitrust laws. On August 27, the judge issued a permanent injunction directing Johnson & Johnson MedTech to stop specific practices in the marketplace, including the so-called case coverage policy. You may know that Johnson & Johnson MedTech’s case coverage policy denied the EP lab clinical support during procedures if third-party reprocessed sensor-enabled catheters were used. Other practices addressed in the injunction include the practice of installing blocking technology in medical devices (“installing any new technology that is intentionally designed to prevent or impede consumables sold by or for someone other than Biosense from operating or functioning with CARTO”) and collection of consumables (devices) that Johnson & Johnson MedTech does not have regulatory approval to reprocess (or a pending application). 

In the permanent injunction, Johnson & Johnson MedTech is directed to advise all customers of the withdrawal of the case coverage policy. However, in addition to this, Johnson & Johnson MedTech’s letter states, "We are not required to provide representations of accuracy, performance, or specifications for third-party reprocessed Consumables or the maps generated using those Consumables, but we cannot withhold clinical support on the ground that we do not provide those representations.” This statement is somewhat confusing, as it brings into question the accuracy and performance of FDA-cleared reprocessed devices. As you know, Innovative Health must submit data to FDA that enables FDA to establish, as a part of the clearance, that the reprocessed devices are substantially equivalent to new devices. This process itself makes it unnecessary for Johnson & Johnson MedTech to "provide representations of accuracy, performance, or specifications for third-party reprocessed consumables”: Their accuracy, specifications, and performance have been established as a part of the clearance process.

As another direct result of the permanent injunction, the Association of Medical Device Reprocessors have opened a hotline and a webpage for hospital staff to report activities that restrict the use of reprocessed single-use devices. The hotline and website are paid for by Innovative Health, which is a member of AMDR. The hotline and webpage are both industry-wide and vendor-neutral, accepting reports about any vendor engaged in anti-reprocessing activities.

• Toll-Free Phone Hotline: 855-893-7002
• Hotline Web Form: https://report.syntrio.com/reprocessin

The hotline allows anonymous reports and is available 24 hours a day, 7 days a week through the web form and toll-free telephone number.

The web form and hotline provide the opportunity for the reporting party to indicate which type of anti-reprocessing activity s/he is complaining about and list several know tactics, including

• Blocking technology
• Withholding or degrading clinical support because a reprocessed device was used.
• Improper device collections
• Warranty threats
• Tampering with assets 
• Coercive pricing structures
• Misinformation about reprocessing

A very important aspect of the hotline is the fact that Innovative Health decided to ask AMDR to operate the hotline. This was done to ensure that the injunction had impact beyond the specific relationship between Johnson & Johnson MedTech and Innovative Health – and beyond electrophysiology. The reason this is important is that these restrictive practices are not limited to Johnson & Johnson MedTech. They are, in fact, symptomatic of a market for medical technology where monopolistic behavior is common. 

MedTech suppliers are gigantic international corporations, while even the largest health system in the US only has a 5% market share. This is a matter of negotiation power: American hospitals simply don’t have the negotiation power to secure their own interests. Another big part of the problem is that hospital systems are actually enabling this behavior, ultimately letting the suppliers win the price war. Why? Because many of the suppliers sell so much product to the hospital that the hospital feels dependent on the supplier. They succeed in intimidating them.

The real problem is not the price of the individual device or instrument. The problem is that the current market dynamics favor the supplier – in every case. If we want to solve this problem, we have to fix the market dynamics. Through a re-engineering of the market dynamics, we have to force the market to favor the patient instead of the bottom line. Monopolistic conditions for too long have permitted suppliers to bully hospital buyers into taking deals that effectively cost more or provide lesser care. The decision in this lawsuit should stop such practices: The decision is also a message to medical suppliers broadly that you cannot coerce hospitals into deals that don’t benefit them and their ability to provide patient care.