The Reason for the Lawsuit
Innovative Health accused BSW of employing tactics that discourage hospitals from using reprocessed catheters supplied by Innovative Health. Biosense Webster was alleged to have leveraged its market dominance to pressure hospitals into avoiding the use of reprocessed and more affordable alternatives.
The Verdict: US Court Finds Violation of Competition Law – J&J Ordered to Pay Millions
On 16 May, a federal jury in California unanimously found that BSW had violated antitrust laws, awarding the plaintiff, Innovative Health, damages of USD 147 million and trebled the amount, as required by law, to USD 442 million.
On 28 August, the court further issued a permanent injunction against Biosense Webster. The injunction:
- prohibits BSW from conditioning its clinical support for cardiac mapping systems on the exclusive purchase of BSW-compatible cardiac mapping catheters, thereby excluding those supplied by competing reprocessors;
- prevents BSW from offering differing levels of clinical support or product availability depending on whether a healthcare facility uses BSW’s own catheters or those reprocessed by another company;
- bans the use of anti-reprocessing “kill switches” or other blocking technologies intentionally designed to render BSW devices inoperable after being reprocessed by third parties;
- prevents BSW from stockpiling used catheters that it does not itself reprocess, thereby denying legitimate access to raw materials for competing reprocessors.
The injunction will initially remain in force for five years, although the court reserved the right to shorten or extend its duration to reflect “market conditions.”
Why the Ruling is Significant and Groundbreaking
The international trade association for medical device reprocessors, the Association of Medical Device Reprocessors (AMDR), has provided a concise assessment of the ruling’s broader significance. Key points include:
This case holds substantial importance for the entire sector. The injunction not only protects Innovative Health but also prevents BSW from exploiting its platform dominance to exclude remanufacturers from the market.
According to AMDR, the ruling reinforces hospitals’ freedom of choice and curtails anti-competitive practices. The court recognised that reprocessed catheters are just as safe as new ones and up to 50 percent more cost-effective. The verdict sends a clear message to the industry that anti-competitive behaviour will no longer be tolerated.
Given J&J’s strong presence in EU member states, similar practices on this side of the Atlantic cannot be ruled out. The US court’s decision may therefore also hold substantive relevance for Europe and influence the broader narrative around medical device reprocessing. Strengthening the regulatory framework for remanufacturing would likewise be desirable within the EU.
AMDR’s Appeal
“This case gives us an opportunity to make it clear to our healthcare partners, hospitals and surgical centres that they no longer have to accept this,” said AMDR President Dan Vukelich in an interview with Healthcare Brew. “They should push back – now more than ever. In light of this serious ruling, I hope that the medical technology industry will choose to work with us rather than against us,” he added emphatically.
Summary available on the AMDR website:
https://amdr.org/courtcase/
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