“A Large Evidentiary Hole”: Court Grants Janssen Summary Judgment in Kickback Case Over Free Infusion Suite Support

On September 30, 2026, Judge F. Dennis Saylor IV of the U.S. District Court for the District of Massachusetts granted summary judgment to Janssen Biotech, Inc. (Janssen) in United States ex rel. Long v. Janssen Biotech, Inc., No. 16-12182-FDS. The relator alleged that free services Janssen provided to physician practices for in-office infusion (IOI) suites were illegal kickbacks to boost sales of two infusible biologic therapies, Remicade and Simponi ARIA. The court disagreed for two independent reasons: the relator lacked evidence that Janssen provided unlawful remuneration, and, even if she had, she lacked evidence that Janssen acted knowingly and willfully. As the court put it, there was “a large evidentiary hole at the heart of this case.”

Background

The relator was a former Janssen Area Business Specialist (ABS) in central Pennsylvania and helped physician practices establish and operate IOI suites. She filed her qui tam in 2016, alleging that Janssen’s help with establishing and running IOI suites was effectively free business consulting that crossed from lawful product support into unlawful “remuneration” in violation of the Anti-Kickback Statute (AKS). The government declined to intervene. After an initial phase of discovery, Janssen moved for summary judgment, arguing, among other things, that there was insufficient evidence of unlawful “remuneration” or that it had acted “knowingly” and “willfully” within the meaning of the AKS. Janssen also argued that the services it provided were First Amendment-protected speech.

The Court’s Analysis

The Relator’s Evidentiary Concessions. The court opened by identifying two unusual features of the case that created substantial evidentiary problems for the relator. First, the relator did not claim to have participated in, and apparently never witnessed, any allegedly unlawful activity. She submitted no affidavit opposing summary judgment and offered no testimony from any other ABS or from any physician or practice manager. As a result, there was almost no direct evidence of what actually happened between Janssen’s representatives and health care providers.

Second, the relator conceded that the slide decks and other written materials Janssen approved for ABSs were lawful. In her view, an ABS who simply read those materials aloud to providers would not have violated the AKS. The relator’s case therefore depended on “live” services that went beyond the written materials. But the relator offered little evidence of what those services were or whether they varied from the approved content. In the court’s words, the circumstantial evidence the relator cited was “sparse at best.”

Independent Value. Even on the evidence the relator did present, the court found no unlawful remuneration. Applying the “substantial independent value” framework drawn from U.S. Department of Health and Human Services Office of Inspector General guidance, the court asked whether Janssen’s services had value to the providers independent of the two relevant medications. The closest the relator came was Janssen’s Infusion Optimization Modeler (IOM), a simple program that used a practice’s own data to help practices estimate how many more infusions they could handle. The court found the IOM was tied entirely to Remicade and Simponi ARIA. Unlike the tools in United States ex rel. Hart v. McKesson Corp., 602 F. Supp. 3d 575 (S.D.N.Y. 2022), aff’d in relevant part, 96 F.4th 145 (2d Cir. 2024), there was no evidence that the IOM compared drug profitability, supported broader practice-improvement services, or was sold separately. The court also noted that evidence the infusion suites could be used for other manufacturers’ drugs would “arguably” show independent value, but the relator offered little more than a single sentence of testimony on the point.

No Evidence of a Knowing and Willful Violation. Even assuming unlawful remuneration, the court found no evidence that any Janssen employee intended to violate the law or that the company was “flagrantly indifferent” to its obligations. Compliance personnel had approved all of the programming, ABSs were trained and barred from business consulting, and there was no evidence demonstrating that employees ignored that guidance. Internal emails flagging “potential risk[s]” showed only that compliance officers “did their jobs,” and Janssen’s prior settlements showed, at most, awareness of the AKS.

First Amendment Defense Rejected. Although the court sided with Janssen on the insufficiency of the evidence of an AKS violation, it rejected Janssen’s argument that the First Amendment requires a narrow reading of “remuneration.” The AKS regulates conduct, not speech, the court explained: “where valuable speech is offered as the quid in a quid pro quo arrangement, prohibiting such arrangements would clearly survive First Amendment scrutiny.”

Takeaways

Concessions can decide a case. Having conceded that the written materials were lawful, the relator had to prove what Janssen said to practices beyond those materials — and failed to do so.

First-hand evidence matters. The court repeatedly noted the insufficiency of testimony from the relator, other ABSs, and physician practices, and declined to let expert characterizations fill that gap.

Documented compliance pays off. Evidence of compliance review, training, and clear limits on consulting allowed the court to treat internal risk flags as one aspect of a functioning compliance program rather than evidence of intent.

For questions about these developments, their implications, or related compliance considerations, please contact the authors or any member of Arnold & Porter’s White Collar Defense & Investigations or Life Sciences & Healthcare Regulatory practice groups.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.