J&J’s Biosense Webster Antitrust Lawsuit: $442M Verdict and Injunction

The Biosense Webster antitrust lawsuit ended in May 2025 with a federal jury in California finding that Johnson & Johnson’s cardiac mapping subsidiary illegally punished hospitals for buying cheaper reprocessed catheters instead of its own. The jury awarded reprocessor Innovative Health $147 million. Judge James V. Selna later tripled that to roughly $442 million under antitrust law, added a five-year injunction, and denied Biosense Webster’s motion to overturn the verdict. The company has appealed to the Ninth Circuit, where the case sits as No. 25-6042 as of mid-2026.

What the Lawsuit Was About

Biosense Webster makes the CARTO 3 cardiac mapping system used during electrophysiology procedures to treat heart rhythm disorders. It holds over 50 percent of the U.S. market for these systems, and CARTO is installed in roughly 72 percent of American hospitals that perform the procedures.¹

Innovative Health, a Scottsdale, Arizona reprocessor, takes single-use cardiac catheters that hospitals would otherwise discard, cleans and sterilizes them under FDA-regulated processes, and resells them at prices up to 30 percent below original cost.² Before 2016, hospitals bought roughly 25 percent of their CARTO-compatible catheters from reprocessors and other non-Biosense sources.³

Innovative Health sued in 2019 in the U.S. District Court for the Central District of California, alleging violations of Sections 1 and 2 of the Sherman Act and California’s Cartwright Act. The trial evidence centered on three overlapping tactics.

Cutting Off Clinical Support

Starting in April 2016, Biosense Webster formalized a policy of providing its free clinical support specialists only to hospitals that bought catheters directly from the company. Hospitals that used reprocessed catheters lost access to those specialists.⁴ That mattered because Biosense held roughly 95 percent of the market for CARTO 3 clinical support by 2018, and hospitals depended on the specialists during procedures given a nationwide shortage of trained electrophysiologists and nurses.⁵ Competitor Abbott, by contrast, provided clinical support regardless of catheter source.¹

The Falcon Chip

Biosense Webster developed an EEPROM component internally called “Falcon” that could detect non-Biosense reprocessed catheters and shut down the CARTO system when one was connected. The technology had been in place since roughly 2014.⁶ Internal emails at trial showed the chip was designed specifically to block competitors from reprocessing devices like the Vizigo sheath.⁷ Innovative Health found workarounds around 2018.

Hoarding Used Catheters

Reprocessors need used devices as raw material. Trial evidence showed that between 2015 and 2020, Biosense Webster collected roughly 156,000 ACUNAV catheters specifically to keep them out of reprocessors’ hands, despite having no reprocessing operation of its own for those devices.⁷

Together the tactics worked. Independent reprocessors’ share of the catheter market fell from about 23 percent to just 1 percent by 2022–2023.⁵

The Verdict and $442 Million Judgment

After a two-week trial, the jury returned a unanimous verdict on May 16, 2025, finding that Biosense Webster violated federal and California antitrust laws by tying clinical support to catheter purchases and using blocking technology to exclude competitors. Damages for lost sales came to $147,406,481.⁸

Antitrust damages are automatically tripled under the Clayton Act and California law. On June 5, 2025, Judge Selna entered judgment for $442,219,443.⁹

Biosense Webster then moved for judgment as a matter of law, arguing Innovative Health had failed to prove distinct markets, market power, or antitrust injury, and that the Cartwright Act should not reach out-of-state damages. Judge Selna denied the motion on August 27, 2025. He pointed to the 95 percent share in clinical support, the collapse of reprocessors’ share from about 16 percent to 1 percent, and evidence of supracompetitive pricing. On the state-law question, he held that nationwide damages were appropriate because the anticompetitive conduct emanated from California, and that tying is illegal per se under California law, making procompetitive justifications irrelevant.⁵

The Five-Year Injunction

On the same day, Judge Selna imposed a five-year permanent injunction on Biosense Webster, Johnson & Johnson, and their subsidiary SterilMed. The order bars four categories of conduct:¹⁰

Conditioning clinical support or CARTO machine availability on the use of Biosense catheters.
Refusing, withdrawing, or degrading support, or charging higher prices, based on a hospital’s use of third-party catheters.
Deploying any blocking technology developed after June 5, 2025, that is designed to prevent non-Biosense devices from working with CARTO. Existing Falcon chips do not have to be removed.
Collecting used catheters unless Biosense has FDA approval to reprocess them or a pending application, with narrow exceptions for defect investigations and scrap-value collection.

The order also requires Biosense to notify past, current, and future CARTO users along with its own sales staff about the ruling, and to submit a compliance report to the court every six months, certified under penalty of perjury by a company executive.¹¹ The court reserved authority to shorten or extend the five-year term based on market conditions.¹⁰ An anonymous compliance hotline for reporting potential violations was set up as part of the order.¹²

Where the Appeal Stands

Johnson & Johnson said after the verdict that it disagreed with the decision and would appeal, maintaining that Biosense Webster’s practices were “pro-competitive” and intended to “ensure patient safety and product performance.”¹³ The case is now before the U.S. Court of Appeals for the Ninth Circuit as No. 25-6042.¹⁴

Biosense Webster is pressing two main arguments on appeal: that courts “extremely rarely” recognize single-brand aftermarkets of the kind the jury found here, and that damages should be reduced by separating out conduct the company contends was lawful.¹⁴ Innovative Health filed its response brief in May 2026 urging the Ninth Circuit to reject those arguments.¹⁵

Several outside groups have filed amicus briefs supporting the verdict. The American Antitrust Institute filed on June 1, 2026.¹⁴ The Open Markets Institute framed the case as a “right to repair” matter and cited the drop in reprocessors’ market share from 23 percent to 1 percent.¹⁶ U.S. PIRG described the three tactics as “mutually reinforcing” and noted that patients in medical crises cannot shop around for alternatives. A group of antitrust law professors called Biosense Webster’s legal position a “mashup of lock-in and foremarket-monopoly that violates settled antitrust principles and common sense.”¹⁷

What It Means for Hospitals and Reprocessors

The Association of Medical Device Reprocessors called the verdict a “watershed moment” and has argued the ruling exposes a broader pattern in the industry, including blocking chips, contract clauses that tie discounts to exclusive use of new devices, and “take-back” programs that destroy used devices before reprocessors can acquire them. The group has published procurement guidance for hospitals, including template contract language meant to prevent manufacturers from conditioning equipment access or discounts on exclusive purchasing.¹⁸

Safety was central to Biosense Webster’s defense. On that point, evidence at trial showed 116 injuries and 10 deaths attributed to original Biosense Webster SoundStar catheters between 2013 and 2023, and zero deaths associated with Innovative Health’s reprocessed versions of the same catheter.⁷ The Ninth Circuit’s ruling will determine whether the judgment and injunction stand.

1
MedTech Dive. Biosense Webster Antitrust Lawsuit Reprocessed Catheters
2
DAIC. Innovative Health Receives Clearance to Reprocess IntellaMap Orion High-Resolution Mapping
3
Court Document via Justia. Innovative Health LLC v. Biosense Webster Inc., Final Judgment
4
Cardiovascular Business. Johnson & Johnson MedTech Ordered to Pay $147M for Antitrust Violations
5
Wolters Kluwer. Innovative Health LLC v. Biosense Webster Inc.
6
AMDR. Order Regarding Motion for Permanent Injunction Modifications
7
AMDR. Statement – Innovative Health Seeks Permanent Injunction Against Johnson & Johnson MedTech’s Biosense Webster
8
Law360. J&J Unit Hit With $147M Verdict in Catheter Antitrust Suit
9
AMDR. Triple Damages: $442M Awarded to AMDR Member Innovative Health
10
AMDR. Permanent Injunction Order
11
Cardiovascular Business. Johnson & Johnson MedTech Hit With Permanent Injunction, Fallout Over Antitrust Lawsuit Continues
12
AMDR. Court Case
13
Cardiovascular Business. Johnson & Johnson MedTech $442M Lawsuit Innovative Health
14
American Antitrust Institute. AAI Amicus – Innovative Health v. Biosense
15
Law360. 9th Circ. Told to Reject J&J Unit’s $442M Antitrust Appeal
16
Open Markets Institute. Open Markets Institute Files Amicus Brief Defending Antitrust Verdict Against Biosense Webster
17
AMDR. Innovative Health v. Biosense Webster Appeal – Summary of Amicus Briefs
18
AMDR. Anti-Reprocessing Interference: Know Your Rights