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Home Compliance

The DOJ Wants Strong FCA Whistleblower Lawsuits From Data Miners

The FOCUS initiative sets parameters for the DOJ’s support of data miners’ qui tam complaints

by Selina P. Coleman, Lesley C. Reynolds, Thomas H. Suddath Jr., David A. Bender and Matthew K. Loughran
May 14, 2026
in Compliance
data abstract numbers

Only the strongest survive. That’s what the DOJ is projecting with the FOCUS initiative, which is meant to bring the agency together with the best data miners digging into FCA whistleblower complaints, write Selina P. Coleman, Lesley C. Reynolds, Thomas H. Suddath, Jr., David A. Bender and Matthew K. Loughran of Reed Smith.

On April 30, the DOJ announced the fraud oversight through careful use of statistics (FOCUS) initiative, a new anti-fraud initiative designed to “improve the Department’s ability to prioritize working with the most successful data miners” filing qui tam, or whistleblower, complaints under the False Claims Act (FCA). 

Under this initiative, the DOJ is inviting data miners to meet with the Civil Fraud Section to discuss their capabilities and outline why and how their data signals reliably correlate to fraud. Although these meetings are not a pre-filing requirement, the DOJ stated that it “will prioritize working with data miners who have demonstrated an investment in pre-filing diligence and commitment to analytical rigor, familiarity with program rules, and legally sufficient allegations.”

The FOCUS initiative signals that data miner relators are here to stay and may improve their filings.

The DOJ trying to filter out unsuccessful cases

The DOJ has received a record number of FCA qui tam complaints in recent years. The DOJ noted in announcing this new initiative it received in 2025 a record 1,300 FCA qui tam complaints, and to date in 2026, it has already received more than 780 qui tam complaints. 

Data miners have accounted for much of this uptick, having filed more than 45% of all qui tam complaints since fiscal year 2024. According to the DOJ, however, recent data from FCA settlements and judgments suggests a lower overall success rate for qui tam complaints filed by data miners relative to department-initiated FCA complaints. Although this is not surprising, because the DOJ has access to non-public information, the DOJ says that “data miners can increase the quality and success of their qui tams by ensuring that they utilize only focused data analytics that identify reliable data signals with a reasonable correlation to fraud.”

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Read moreDetails

DOJ offers guidance to relators

To ensure effective use of enforcement resources, the DOJ explained that it will prioritize high-quality data miner actions and offered guidance to relators and counsel who seek to use data mining in qui tam cases, including to: 

  • Provide “high-quality, reliable, and predictive data analyses and signals and a thorough understanding of the relevant legal obligations.” 
  • Be aware of the “heightened pleading standard of Rule 9(b) of the Federal Rules of Civil Procedure,” which requires pleading fraud with particularity.
  • Provide “alternative explanations for the observed conduct and be able to articulate how the data, in combination with other available evidence, suggests both scienter and falsity.” 
  • Consider partnering “with others who can aid their understanding of program eligibility requirements and regulatory frameworks.”

Key takeaways for qui tam targets

Although the DOJ’s announcement of the FOCUS initiative signals that data miner relators are here to stay and may improve their filings, certain key takeaways stand out.

The FOCUS initiative may shift the DOJ away from collaborating with unsophisticated data miner relators who leverage the FCA as a mechanism for pursuing a windfall. Instead, the announcement suggests the DOJ will more closely scrutinize data miner relators, focusing instead on collaborating with those who are mindful of the heightened pleading requirements under the FCA and who can more reliably correlate their analyses to substantiating claims of fraud. 

Although the result may be that FCA defendants will contend with more sophisticated cases that are harder to dismiss for failing to plead with specificity or similar grounds, those cases can, in some cases, offer FCA defendants a unique defense — the FCA’s public disclosure bar, which, in some cases, bars FCA cases predicated on publicly disclosed, data mined information if the government does not intervene. 

This article was originally published on Reed Smith’s site and is adapted here with permission.

Tags: DOJHealth Care
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Selina P. Coleman, Lesley C. Reynolds, Thomas H. Suddath Jr., David A. Bender and Matthew K. Loughran

Selina P. Coleman, Lesley C. Reynolds, Thomas H. Suddath Jr., David A. Bender and Matthew K. Loughran

Selina P. Coleman is a partner in the Washington, D.C., office of Reed Smith. She defends healthcare companies in high-stakes litigation, including False Claims Act cases and national class actions.
Lesley C. Reynolds is managing partner of Reed Smith’s office in Washington, D.C. She assists numerous clients with some of their most complicated, contentious and high-profile litigation and regulatory matters.
Thomas H. Suddath Jr. is a partner in the Philadelphia office of Reed Smith. He represents companies and individuals, particularly within the healthcare sector, involved in criminal and other government investigations and related civil litigation, including matters under the FCPA, the False Claims Act (FCA), the Sherman Act, the federal Food Drug and Cosmetic Act and the Anti-Kickback Statute.
David A. Bender is a member of the life sciences health industry group in Reed Smith’s Washington, D.C. office, where he assists on an array of healthcare litigation and regulatory matters.
Matthew K. Loughran is a health policy analyst in Reed Smith’s life sciences health industry group, based in Washington, D.C.

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