Hansen v. Johnson Technology Lawsuit: $442M Verdict and Appeal

In Innovative Health v. Biosense Webster, a federal jury in California awarded $147 million in May 2025 to a medical device reprocessor that accused Johnson & Johnson’s Biosense Webster unit of illegally locking competitors out of the market for cardiac mapping catheters. The trial judge trebled the award to $442 million under antitrust law and later imposed a five-year injunction reshaping how Biosense sells and supports its CARTO 3 platform. Biosense has appealed to the Ninth Circuit, where the case remains pending.¹

The dispute centers on the CARTO 3 cardiac mapping system, which Biosense sells alongside the disposable electrophysiology catheters it makes. Innovative Health reprocesses those single-use catheters, sending them through the same FDA 510(k) clearance process as new devices so hospitals can reuse them at lower cost.²

What Biosense Was Accused of Doing

Innovative Health’s case rested on three categories of conduct, all tied to Biosense’s dominance over the CARTO 3 ecosystem.

Withholding Clinical Support

Biosense employed “clinical account specialists” who provided free technical support to hospitals during cardiac mapping procedures. Under a written company policy, that support was denied whenever a hospital used a reprocessed catheter instead of a Biosense original. Competitors such as Abbott, by contrast, supported their mapping machines regardless of which catheter a hospital chose.³ The jury found this was an illegal tying arrangement under Section 1 of the Sherman Act: hospitals could only get support they needed for the CARTO 3 if they agreed to buy Biosense catheters.⁴

Hardware Blocking Through the “Falcon Chip”

Biosense embedded an electronically erasable programmable read-only memory chip, known internally as the Falcon chip, in its catheters. The chip communicated with the CARTO 3 system and could recognize when a catheter had been reprocessed by a third party. When it detected a non-Biosense catheter, the system would shut down, rendering the reprocessed device unusable.⁵ Internal communications introduced at trial indicated the technology was deployed to hinder reprocessing rather than to improve device performance.⁶ The jury found this conduct violated Section 2 of the Sherman Act as unlawful monopolization.

Collecting Catheters to Keep Them From Competitors

Innovative Health also alleged Biosense collected used catheters from hospitals that it had no plans to reprocess itself, keeping the devices out of rivals’ hands. Between 2015 and 2020, Biosense collected roughly 156,000 ACUNAV catheters, sold about 59,000 back to the market, and withheld approximately 54,000. Internal communications described a goal of driving Stryker out of the reprocessing business.⁷ The court later noted the verdict form did not separate this conduct, so it is unclear how much weight the jury gave it in reaching the Section 2 finding.⁴

The Verdict and the $442 Million Award

On May 16, 2025, the jury returned a unanimous verdict for Innovative Health on all four claims tried: unlawful tying under the Sherman Act, unlawful monopolization under Section 2, attempted monopolization under Section 2, and unlawful tying under California’s Cartwright Act. Damages totaled $147,406,481, of which $8 million was tied specifically to delayed market entry caused by the blocking technology.⁴²

On June 4, 2025, the court trebled the award to $442,219,443 under the mandatory trebling provisions of federal and California antitrust law.¹

What the Injunction Requires

On August 27, 2025, the court signed a permanent injunction lasting five years. The order goes beyond damages and directly restricts how Biosense operates:⁵⁸

Biosense cannot condition clinical account support or CARTO availability on whether a hospital buys Biosense catheters, and cannot degrade service or raise prices for hospitals that use a competitor’s product.
Biosense cannot deploy any new technology after June 5, 2025, designed to prevent third-party catheters from working with CARTO 3. Technology already in place before that date, including the Falcon chip on the Soundstar Eco catheter, is grandfathered in.
Biosense cannot collect used catheters unless it has regulatory approval, or a pending application, to reprocess them.
A Biosense executive must file a sworn compliance report with the court every six months, disclosing any potential violations.
The company must maintain a hotline for hospital staff and its own employees to report anticompetitive practices.

The Ninth Circuit Appeal

Biosense filed its notice of appeal on September 25, 2025. In its opening brief, filed February 17, 2026, the company challenges the verdict on two main grounds. It argues that courts rarely recognize “single-brand aftermarkets” and that there is a legal presumption against treating one company’s product ecosystem, in this case CARTO clinical support, as its own market. It also argues that the $147 million damages figure should be cut because it includes losses attributable to conduct Biosense contends was lawful.⁹

Innovative Health filed its answering brief on May 20, 2026, urging the court to uphold the judgment and the trial court’s finding that Biosense forced hospitals to avoid reprocessed catheters.¹⁰ The appeal remains pending. A Johnson & Johnson spokesperson has said the company disagrees with the verdict and maintains that its practices are “pro-competitive” and intended to ensure patient safety.³

1
Becker’s Hospital Review. Judge Triples Damages to $442M in J&J Catheter Case
2
HMP Global Learning Network. Innovative Health Prevails in Lawsuit Against J&J’s Biosense Webster for Restraint of Trade
3
MedTech Dive. Biosense Webster Antitrust Lawsuit Reprocessed Catheters
4
AMDR. Innovative v. Biosense Permanent Injunction Tentative Order
5
AMDR. Innovative Health v. Biosense Webster Permanent Injunction
6
Business.cch.com. Innovative Health LLC v. Biosense Webster Inc.
7
AMDR. Statement: Innovative Health Seeks Permanent Injunction Against Johnson & Johnson MedTech’s Biosense Webster
8
Cardiovascular Business. Johnson & Johnson MedTech Hit With Permanent Injunction as Fallout Over Antitrust Lawsuit Continues
9
American Antitrust Institute. AAI Amicus: Innovative Health v. Biosense
10
Law360. 9th Circ. Told to Reject J&J Unit’s $442M Antitrust Appeal