Almost two years after Judge Kathryn Kimball Mizelle of the U.S. District Court for the Middle District of Florida became the first federal judge in the country to declare the qui tam provisions of the False Claims Act (FCA) unconstitutional, the U.S. Court of Appeals for the Eleventh Circuit vacated Judge Mizelle’s September 30, 2024, order and held that the FCA’s qui tam provisions do not violate the Appointments Clause of the U.S. Constitution. The case now returns to the District Court.
On September 1, 2026, a unanimous panel of the Eleventh Circuit concluded in United States ex rel. Zafirov v. Florida Medical Associates LLC that qui tam whistleblowers, or relators, who bring a case under the federal FCA in the name of the U.S. government are not “officers of the United States” occupying a “continuing position established by law.”
However, the lower court considered only the Appointments Clause; on remand, the Middle District of Florida must consider, in the first instance, whether the same qui tam provisions violate the Constitution’s Vesting and Take Care clauses.
What may have seemed like an out-of-the-blue question to the casual observer was no surprise to those who represent individuals and entities in the health care and life sciences industries: U.S. Attorney General (AG) nominee Pam Bondi was asked to share her thoughts on the constitutionality of the False Claims Act (FCA) and its qui tam provisions during her January 15, 2025, confirmation hearings.
Senator Chuck Grassley (R-IA) prefaced his questioning by noting that the FCA is “central to fighting government waste and fraud.” And since 1986—when Grassley authored amendments that modernized and strengthened the Civil War-era statute—he has been a fierce defender. Since the 1986 amendments, the FCA has brought in $78 billion for the federal government, with more than $2.9 billion recovered in fiscal year (FY) 2024.
“Most of that is due to patriotic whistleblowers who found the fraud and brought the cases forward at their own risk,” Grassley said.
Recent Updates
- FTC Reverses Course on Health App Privacy
- The Battle Continues: No Appointments Clause Problem, BUT Eleventh Circuit Directs District Court to Consider Whether False Claims Act Qui Tam Provisions Violate Take Care, Vesting Clauses
- Bill Gates Gazes into the AI Crystal Ball: What are the Implications on the Healthcare and Life Sciences Industry
- 250+ Health Care Entities Targeted by HHS, DOJ Over Gender-Affirming Care for Minors
- Exclusion Authority (It’s Not Just the HHS-OIG Anymore …)