by
Gus Iversen, Editor in Chief | June 11, 2025
A federal judge has tripled a jury’s damages award against Johnson & Johnson’s Biosense Webster unit to $442 million, finding the company violated antitrust laws by restricting support for hospitals using reprocessed electrophysiology catheters.
The judgment, entered June 5 by Judge James V. Selna of the U.S. District Court for the Central District of California, follows a
May 16 jury verdict awarding $147 million to Innovative Health, a member of the Association of Medical Device Reprocessors (AMDR). The court found that Biosense Webster had violated both federal and California antitrust statutes by withholding clinical support from hospitals that chose to use FDA-regulated reprocessed catheters supplied by Innovative Health.
In addition to tripling the damages under provisions of the Sherman Act and California’s Cartwright Act, the court imposed post-judgment interest and left the possibility open for injunctive relief and attorneys’ fees, potentially raising the financial exposure for the Irvine, California-based Biosense Webster.
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“This is a seismic result,” said Daniel J. Vukelich, president and CEO of AMDR. “The court not only affirmed what the jury found... but took the additional step of tripling the damages, as allowed under antitrust law.”
Innovative Health had alleged that Biosense Webster used its market position to retaliate against hospitals using reprocessed devices, a practice permitted under FDA oversight. The case highlighted tactics such as refusing clinical support, deploying software updates that disabled reprocessed products, and embedding chips to block reuse.
AMDR is urging hospitals to adopt internal policies that document and challenge such behavior. Among the suggested steps are requiring approval for software updates, reviewing contract clauses for anti-reprocessing restrictions, and flagging pricing strategies that disincentivize reuse.
The case could set a precedent for how courts respond to original equipment manufacturers accused of undermining reprocessed medical device adoption. AMDR has indicated it is evaluating further legal options in response to broader industry practices.
