The U.S. government recently announced a record $6.8 billion in False Claims Act settlements and judgments in 2025, the most in a single year since the law’s enactment 163 years ago. For those concerned with scientific integrity, another significant FCA record was also set in 2025: the number of suits brought under the FCA by private individuals against entities they believe defrauded the federal government.
Successful qui tam suits brought under the FCA can come with incentivizing monetary rewards – sometimes substantial – for the whistleblowers. Whistleblowers filed a record 1,297 of these so-called qui tam lawsuits in 2025, up from 979 suits in 2024.
Despite the FCA’s banner year, legal experts say a pending challenge may weaken the law’s whistleblower power and impact. A Florida district court recently struck down the FCA’s qui tam provisions as unconstitutional because these suits involve individuals suing on behalf of the government. If an appeals court upholds the decision, some whistleblowers in that court’s jurisdiction may no longer get paid for exposing wrongdoing, a change that could allow more fraud to slip under the radar, legal analysts say.
While the qui tam provisions are most commonly used in health fraud cases, whistleblowers have also used the mechanism to expose scientific misconduct and grant fraud. In December, the Dana-Farber Cancer Institute agreed to pay $15 million to settle claims it misrepresented data in National Institutes of Health (NIH) grant applications, and in January 2025, Athira Pharma agreed to pay $4 million for manipulating data in federal grant applications.
Over the last decade, plaintiffs have also been successful in cases involving Columbia, the Brigham and Women’s Hospital, and Duke University.
“If the qui tam provisions get overturned, it puts a shield back over the insiders,” J. Michael Slocum, a Virginia-based attorney who specializes in grants, clinical and research contracts, and research ethics, told us. “They have no real incentive, other than good science, to come forward and be the spear point to break the veil.”
Judge: Whistleblower provisions defy constitution
The FCA has faced legal challenges over the years, but courts have upheld the constitutionality of the measure. That is, until September 2024, when Judge Kathryn Kimball Mizelle of the U.S. District Court for the Middle District of Florida overturned the FCA’s qui tam provisions in Zafirov v. Florida Medical Associates, LLC.
In Zafirov, a whistleblower, known in these cases as the “relator,” sued Florida Medical Associates and other providers, claiming they misrepresented patients’ medical conditions to inflate Medicare reimbursements. In qui tam cases, the Department of Justice can decide to join the suit and whistleblowers receive 15 to 25 percent of proceeds if the case is successful. If the government declines to intervene, whistleblowers can continue the suit on their own and retain 25 to 30 percent of proceeds if they succeed. In the Duke case, which settled for $112.5 million, former lab technician Joseph Thomas brought suit and received $33.8 million.
The government declined to intervene in the Zafirov case, which Mizelle dismissed. She ruled the FCA’s whistleblower provisions defy the Constitution by allowing “unaccountable, unsworn, private actors to exercise core executive power with substantial consequences to members of the public.”
Zafirov appealed to the 11th U.S. Circuit Court of Appeals, which heard oral arguments on December 12.
Attorneys for both the government and for Zafirov argued for keeping the provisions intact. The government contends that every other court that has addressed the constitutionality of the FCA’s qui tam provisions has upheld them, and the 11th Circuit “should join that consensus and reverse the district court’s outlier ruling,” according to its appeals brief. Past case law makes clear that relators do not exercise executive power when they sue under the act, the government argued.
“Rather, [relators] are pursuing a private interest in the money they will obtain if their suit prevails,” the government said. “As private litigants pursuing private interests, relators are not enforcing federal law in a manner inconsistent with the Vesting and Take Care Clauses and need not be appointed in the manner required by the Appointments Clause.”
Attorneys for Zafirov similarly argued the district court’s decision conflicts with unanimous precedent, and that qui tam plaintiffs are “private parties pursuing partially assigned claims, not government officers wielding executive power,” according to the plaintiff’s court brief.
The defendants countered that the FCA violates Article II of the Constitution by authorizing private parties to bring suit on behalf of the United States. That article appoints “officers” of the United States, defined as those who occupy a continuing position established by law and exercise “significant authority pursuant to the laws of the United States.”
“Private parties acting as relators may initiate enforcement actions in the government’s name, conduct those actions as they wish, seek trouble damages and statutory penalties, and bind the government through judgments,” Kannon Shanmugam, an attorney for the defendants, said during the December 12 oral arguments. “There can be no doubt that relators exercise significant executive authority in each of those respects, and yet they are not properly controlled by, appointed by, or accountable to the executive branch.”
Effects on research misconduct
If the qui tam provisions are overturned by the 11th Circuit, the outcome would impact a relator’s ability to file a lawsuit on behalf of the United States and collect the relator’s share of damages in the court’s jurisdiction, which includes Florida, Georgia, and Alabama, said Paul Thaler, a Washington, D.C.-based attorney who represents scientists and institutions in research misconduct matters. However, the change wouldn’t affect a relator’s ability to share information with the federal government, act as a witness in an investigation or share their allegations publicly, said Thaler, a partner at Cohen Seglias.
“Without the monetary incentive, however, relators may have less of a reason to come forward and will likely have fewer options to be represented by attorneys without hourly fees [as] most qui tam attorneys work on a contingency basis,” he told us.
According to Renée Brooker, a Washington, D.C.-based whistleblower attorney with Tycko & Zavareei LLP who specializes in FCA cases, a ruling by the 11th Circuit against the qui tam provisions would only affect cases where the government does not intervene in Alabama, Florida, and Georgia. In cases in which the government joins the suit, whistleblowers could still recover proceeds if the case is successful.
“The result will be rampant and unaddressed fraud” in the healthcare industry in the affected states, she said.
Insiders are particularly helpful in research misconduct cases, added Eva Gunasekera, a whistleblower attorney at Tycko & Zavareei and former senior counsel for healthcare fraud at the DOJ. Unlike health fraud, where government officials may open investigations based on data trends they’ve discovered, they’re not likely to spot falsified research without help.
“With research integrity, there would be nothing identifiable, unless the FDA or NIH happened to question something they received in response to a grant application,” she told us. “Most companies are pretty good about making sure their government submissions are all buttoned up. You’d have to literally pull the curtain back, Oz style.”
Removing the qui tam provisions would essentially “blow up” the FCA in “a very harmful way,” Brooker said. She called the qui tam challenge “inconvenient, distracting and an enormous waste of the government’s time.”
“I don’t see anybody in this administration, and certainly not any prior administration, that wants to destroy the False Claims Act and the power of whistleblowing,” she said.
The FCA helps control and focus enforcement efforts where there may be fraud based on information brought to the government’s attention, Brooker said.
“We don’t want to be in a position where the government is serving subpoenas, or what’s known as ‘civil investigative demands,’ on anybody,” she told us. “We don’t want to encourage the government to open an investigation when they have no other reason and no inside information.”
Thaler noted research misconduct claims are most often pursued under Public Health Service (PHS) and National Science Foundation (NSF) federal regulations, and not the FCA. The FCA mechanism is more frequently used when bringing lawsuits against institutions regarding allegations of widespread failure to follow PHS or NSF guidelines for which the institutions sign assurances of compliance, he said.
Thaler noted research misconduct matters brought under the PHS and NSF regulations do not have a monetary incentive to report, yet those matters have “not suffered from a lack of complaints.”
Supreme Court or bust?
Slocum said the final decision about the FCA will come from the U.S. Supreme Court. Some justices have posed questions about the provisions in recent cases, suggesting a need for reexamination.
In a dissenting opinion in Polansky v. Executive Health Resources, Inc., Justice Clarence Thomas wrote the FCA’s qui tam provisions have “long inhabited something of a constitutional twilight zone” that is “inconsistent with Article II and that private relators may not represent the interests of the United States in litigation.” In her ruling, Mizelle, who clerked for Thomas, referenced that dissent.
Justices Amy Coney Barrett and Brett Kavanaugh agreed with Thomas in Polansky, with Kavanaugh writing the court should consider the constitutionality issue in a future case.
“In one direction or the other, it’ll end up at the Supreme Court,” said Slocum, a senior member of the law firm Slocum & Boddie in Alexandria, Virginia. “Until this Supreme Court, I don’t think any challenge against the FCA would have made it very far. This was such a settled area of the law until the last 10 years or so.”
However, Brooker said she does not see the case reaching the Supreme Court just yet. If the 11th Circuit rejects the qui tam provisions, the court will be an outlier among other circuits. In January 2026 for instance, the U.S. Court of Appeals for the 6th Circuit upheld the FCA’s constitutionality, denying arguments to reconsider its precedent, and in June, the U.S. Court of Appeals for the 9th Circuit also reaffirmed the statute.
“It’s not the norm for the Supreme Court to take up a circuit split where there’s only one circuit that’s an outlier,” she said. “The Supreme Court has bigger fish to fry.”
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