As the Janssen appeal of a $1.6 billion False Claims Act (FCA) judgment makes its way through the U.S. Court of Appeals for the Third Circuit, the constitutionality of the statute takes center stage. As previously discussed, Janssen is currently in the process of appealing one of the largest judgments ever issued under the FCA. On October 29, 2025, Janssen completed briefing to the Third Circuit on that appeal. The briefs filed by the parties articulate two hotly debated constitutional arguments that could significantly alter practice under the FCA. Janssen argued: 

• The FCA's qui tam provisions improperly delegate to relators the executive authority to pursue punitive quasi-criminal penalties in violation of Article II
• The civil penalties imposed violate the Fifth Amendment's Due Process Clause or Eighth Amendment's Excessive Fines Clause 

In its reply brief, Janssen reiterated its constitutional attacks. Again noting that three Supreme Court justices have recently questioned the FCA's qui tam device, Janssen highlighted how the facts of the case make the problems with the qui tam provisions "especially stark." Janssen explained:

Relators and the Government are in open disagreement about how to interpret the statute that they both purport to enforce. Relators obtained a $1.6 billion judgment on a theory that allegedly off-label marketing is sufficient to demonstrate falsity under the FCA, yet the Government has 'repeatedly articulated'—and asserts directly to this Court—that '[a] finding that a company has marketed its drugs for off-label uses is not, without more, sufficient to find that subsequent claims for the marketed drugs are false within the meaning of the False Claims Act.' And that sky-high award stems from prescription drug reimbursements that the Government never stopped paying and expresses no intention now to cease or clawback. The Constitution is designed to ensure that unaccountable private plaintiffs who are under no obligation to pursue the public interest do not set the Executive's law enforcement priorities.

Janssen also argued that the "unprecedented" award of $1.2 billion in civil penalties was unconstitutionally excessive, especially in light of the case circumstances where relators conceded a "lack of individualized evidence of patient harm" resulting from the company's alleged fraud.

On October 28, a day before Janssen filed its reply brief, yet another federal district court rejected the argument that the FCA's qui tam provisions are unconstitutional. In U.S. ex rel. Todd Heath v. Wisconsin Bell, Inc., No. 2:08-CV-00724 (E.D. Wis. Aug 26, 2008), a case involving alleged violations of the FCA under the Federal Communications Commission's (FCC) Education Rate program, Judge Lynn Adelman held that relators are not appointed "Officers of the United States" because they do not wield "significant" or "continuing and permanent" authority such that the Appointments Clause is not violated by the FCA's qui tam provisions. Further, because the "government retains significant control over qui tam actions and can intervene to direct litigation in a particular way," the FCA does not violate the Vesting and Task Care Clauses. In so doing, the Eastern District of Wisconsin joined five circuit courts and numerous district courts who have upheld the constitutionality of the relator suits under the Act. 

However, in a concurring opinion on November 3, Judge James Ho of the Court of Appeals for the Fifth Circuit stated the court should "revisit whether there are serious constitutional problems with the qui tam provisions of the False Claims Act," because relators are not appointed by or accountable to the president, thus infringing on the president's executive power under Article II. The question of the FCA's constitutionality is also on appeal to the Eleventh Circuit in Clarissa Zafirov v. Florida Medical Associates, LLC, et al., No. 24-13581 (11th Cir. Oct 30, 2024), which is set for oral argument on December 12, 2025. We have written about that closely watched appeal here.

If you have any questions about the Janssen case, or questions about the FCA generally, contact one of the Miller & Chevalier attorneys listed below. 

Joshua Drew, jdrew@milchev.com, 202-626-5811

Ian A. Herbert, iherbert@milchev.com, 202-626-1496

Bradley E. Markano, bmarkano@milchev.com, 202-626-6061

Connor W. Farrell, cfarrell@milchev.com, 202-626-5925 

The information contained in this communication is not intended as legal advice or as an opinion on specific facts. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. For more information, please contact one of the senders or your existing Miller & Chevalier lawyer contact. The invitation to contact the firm and its lawyers is not to be construed as a solicitation for legal work. Any new lawyer-client relationship will be confirmed in writing.

This, and related communications, are protected by copyright laws and treaties. You may make a single copy for personal use. You may make copies for others, but not for commercial purposes. If you give a copy to anyone else, it must be in its original, unmodified form, and must include all attributions of authorship, copyright notices, and republication notices. Except as described above, it is unlawful to copy, republish, redistribute, and/or alter this presentation without prior written consent of the copyright holder.