Health Law Daily Wrap Up, QUI TAM (WHISTLEBLOWER SUITS)—D. Mass.: Relator had no evidence that Janssen infusion product programming violated AKS, (Oct 8, 2026)

By Justin Marcus Smith, J.D.

The court was critical of the relator’s evidence and her approach to presenting it, but the bottom line was that Janssen product programming had no substantial independent value to physicians.

Janssen Biotech, Inc. (Janssen) was entitled to summary judgment in connection with a qui tam relator’s allegations that it violated the Anti-Kickback Statute (AKS), held the federal district court in Boston, Massachusetts. The court began its analysis by rejecting the Janssen argument that the First Amendment necessarily protected infusion product programming. However, Janssen ultimately prevailed on summary judgment because there was essentially no evidence that its programming, which was essentially product support, had substantial independent value to physicians that might qualify as unlawful remuneration under the AKS. Mere acknowledgment that the infusion product programming might be of interest to physicians who wanted to infuse other medications fell well short of proof of an AKS violation. The court found the advice provided was limited to infusion process efficiency information. Janssen representatives did not take any actual steps to help practices increase infusion capacity. Importantly in light of the applicable case law, there was no indication that the programming amounted to valuable consulting services, for example, services that would have taught individual practices how to maximize their profits by exploring comparative interchangeability scenarios with other infusion products. There was also no evidence to suggest that Jannsen knowingly or willfully violated the AKS (U.S. ex rel. Long v. Jannsen Biotech, Inc., No. 1:16-cv-12182-FDS (D. Mass. Sept. 30, 2026)).

Background. In 2016, a former employee (relator) who was employed as an Area Business Specialist (ABS) brought a qui tam action against Janssen Biotech, Inc. (Janssen) alleging that Janssen unlawfully provided free business consulting services to physicians to induce them to prescribe the Janssen infusible medications Remicade and Simponi ARIA. Remicade is approved for treating Crohn’s disease and various forms of arthritis and colitis. Simponi ARIA is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

The relator contended the free services were illegal kickbacks that violated the Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b, which in turn led to submission of false claims for payment in violation of the False Claims Act (FCA), 31 U.S.C. § 3729 et seq. The relator’s job with Janssen as an Area Business Specialist (ABS) had been to promote the sale of Remicade and Simponi ARIA in central Pennsylvania. That included providing advice or assistance with establishing and operating in-office infusion (IOI) suites in physicians’ offices. The relator thought those services crossed the line from lawful marketing or medical and clinical support of the products to unlawful “remuneration” in violation of the AKS.

In 2019, the government declined to intervene, and in 2020, the court granted a Janssen motion to dismiss as to the state-law FCA analogs but denied it as to the federal FCA claims.

At length, Janssen moved for summary judgment on the issues of (1) whether there was unlawful remuneration within the meaning of the AKS; (2) whether it acted “knowingly” and “willfully” within the meaning of the AKS; and (3) whether there was sufficient evidence of an FCA violation. The court said the central question was not whether Janssen had a profit motive, but whether the evidence showed the consulting services had value “independent” of the medications.

The court noted two unusual aspects to this case. First, the relator did not herself participate in or witness any allegedly unlawful activity. Nor did she submit an affidavit or deposition testimony from any other ABS. She offered almost no direct evidence as to the alleged events, the actual interactions between Janssen representatives and physician practices, at the center of the lawsuit. Second, the relator conceded during discovery and again at summary judgment that the content of presentation materials, primarily slide decks, did not constitute the provision of unlawful consulting services in violation of the AKS. She contended instead that ABS’ provided unlawful “live” services, that they said or did things while meeting with physician practices that went beyond the content of the written materials in violation of the AKS. That called into question the nature of the “live” services and whether they materially varied from the written materials, but there was no direct evidence as to what was said or done on any of those meetings.

A further problem was that the relator did not put forth sufficient evidence to show Janssen “knowingly and willfully” violated the statute. The court was also critical that the relator buried the court in an “avalanche” of exhibits that frequently did not support her contentions, or were simply irrelevant, and used multiple cross-references to citations that were themselves irrelevant; that involved another layer of cross-references; that used misleading quotations from a key exhibit; and that substituted conclusory or argumentative assertions for statements of fact.

Relevant programming. There were ten slide decks in the evidentiary record. They covered the following topics: (1) billing and coding for infusions; (2) considerations for proactive practice management; (3) considerations for working with a specialty pharmacy; (4) payer policy exceptions and appeals process; (5) infusion referrals and improving the continuity of care; (6) infusion services and ambulatory surgical centers; (7) Medicare (Part B) Quality Payment Program; (8) successful implementation of new infusion suite for gastroenterology practices; (9) successful infusion suite management for gastroenterology; (10) managing biologics in the physician office.

The related “Hot Buttons” program took the form of an iPad app that interactively allowed physician customers to indicate which areas of the operation of their practice could use improvement. The ABS could then present a corresponding slide deck.

Another form of programming was called the “Infusion Optimization Modeler” (IOM). The aim of IOM was to provide practices with information about their infusion capacity and the potential to increase it based on practice details. It would purport to show how practices could increase infusion capacity by addressing specific constraints like the number of chairs or staff. ABS’ focused on marketing at what Janssen referred to as the “Site of Care” (SOC), i.e., the location where the practice infused patients.

At some point, Janssen engaged Xcenda, a subcontractor, to provide consulting services in connection with ABS programming. According to Janssen, Xcenda personnel supplemented ABSs in the field, received the same training, performed the same role, and presented the same materials as an ABS. The relator contended the payment of $3,000 per session to Xcenda was evidence that the ABS presentations had substantial value.

However, Janssen had compliance policies intended to ensure legal compliance, including AKS compliance, and the AKS does not specifically define what constitutes “remuneration” other than providing three examples of a “kickback,” “bribe,” and a “rebate.”

Remuneration standard. Courts interpret the meaning of “remuneration” to include services that have “substantial independent value” to the recipient. The court applied the “substantial independent value” standard.

First amendment. The court denied Janssen summary judgment on whether the First Amendment necessarily protected the services at issue. Janssen contended the term “remuneration” had to be construed narrowly to avoid First Amendment concerns from holding that truthful promotional speech can be illegal remuneration. The relator countered that the First Amendment did not shield pharmaceutical manufacturers from the consequences of providing illegal inducements to prescribers.

The court cited how the Supreme Court has recognized that pharmaceutical marketing is a form of commercial speech entitled to some First Amendment protection. The AKS does not prohibit pharmaceutical marketing from offering information to physician practices in the abstract, it only prohibits them from offering valuable inducements to sales. There cannot be a quid pro quo, and to that extent, the AKS did not raise categorical First Amendment concerns.

Services value. The court said there was no real question that the services Janssen provided had “value” that was “substantial” in the sense that it was not immaterial or de minimis. It was also evident that the purpose of the SOC programming was to increase sales of Remicade and Simponi ARIA. However, the record evidence showed the IOM presentations constituted product support that did not have substantial independent value to the physician practices.

The relator contended the infusion suites had independent value because they could be used for infusion of other medications. That would arguably show, by extension, that the services provided to help establish the suites also had “independent” value. However, the relator essentially conceded that the slide decks were “unbranded,” did not mention Remicade or Simponi ARIA, and were lawful. The court further analyzed that mere acknowledgment that the SOC programming might be of interest to physicians who wanted to infuse other medications “f[ell] well short of proof of an AKS violation.”

The relator’s case centered instead on what she called “hands-on, practice specific business consulting services” that ABSs provided to infusion practices. The relator made multiple arguments that those services had independent value, but the court disagreed.

First, it was not clear how the magnitude of the programming related to “independent” value, albeit it might show how much Janssen thought it would lead to higher sales. Second, there was no evidence that any ABS actually provided any “overall practice management” services to physicians. Third, the fact that the services had value, i.e., $3,000 payments to Xcenda to provide them, was not in serious dispute. The only question was whether they had “independent” value, and the relator offered no evidence in opposition to Janssen’s contention that the ABSs provided the same services as Xcenda. There was also no evidence about what any Xcenda representative specifically said or did.

As for whether the services had independent value because they were individually “tailored” or “customized” for specific physician practices, the relator focused on IOM and two other programs allegedly designed to help improve the efficiency of IOI suites and therefore increase physician profits. Although tailoring might be relevant, the court said it was not controlling. The relator conceded that one internally-approved slide deck, which made suggestions about things like nurse-to-patient ratio, was lawful. The court found the advice provided was limited to infusion process efficiency information. ABSs did not take any actual steps to help practices increase infusion capacity.

The court also found the service provided through IOM was “distinguishable from the business advice the courts have found to constitute unlawful remuneration in other AKS cases.” For example, the advice provided did not provide a margin analyzer to compare reimbursement rates of interchangeable drugs to show which would yield the highest profit for the practice. See 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). The allegations in Hart went “well beyond mere provision of those tools.” Such was not the case here. The IOM presentations did not have substantial independent value to the physician practices.

In summary, the relator failed to present enough evidence to show Janssen provided services having “substantial independent value” in order to induce physician practices to buy Remicade or Simponi ARIA. The court accordingly concluded the evidence did not support a finding of a violation of the AKS.

Scienter. The court elected to continue exploration of whether the evidence supported a finding of a knowing and willful AKS violation, but it concluded there was no suggestion that any employee believed the marketing programs, as implemented, violated the AKS or any other law. After a lengthy consideration of the evidence, legal concepts, and potential issues, the court found the evidence fell well short of establishing that the corporation as a whole was flagrantly indifferent to its legal obligations. For example, the mere fact that Janssen settled other cases, had little relevance to this case. The court also found that compliance officers were merely doing their jobs when they commented on training materials or discussed potential risks.

The relator could not make out an AKS claim, and Janssen was therefore entitled to summary judgment. The court did not need to address Janssen’s arguments about the False Claims Act. For the same reasons, the court denied the relator’s cross-motion for summary judgment.

The case is No. 1:16-cv-12182-FDS.

Judge: Saylor, D.

Attorneys: Jonathan Shapiro (Shapiro & Teitelbaum LLP) for the U.S. Amber Michelle Charles (Covington & Burling LLP) for Janssen Biotech, Inc.

Companies: Janssen Biotech, Inc.

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