> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Feds Interested in FDA-based False Claims Cases: Attorneys
- URL: https://www.fdaweb.com/feds-interested-in-fda-based-false-claims-cases-attorneys/
- Published: 2022-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:00:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152845

Three Covington attorneys say a Department of Justice (DoJ) statement of interest in a recent Florida federal court whistleblower case “shows that the government continues to be interested in pursuing False Claims Act (FCA) cases premised on alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) and FDA regulations.” The Florida case involved a whistleblower’s claims relating to Trividia Health’s manufacture and sale of diabetes test strips.

Writing in a Covington *Alert*, the attorneys say the whistleblower’s theory was premised on allegations the company violated FDA good manufacturing practices and medical device reporting regulations.

The court granted the company’s motion to dismiss the case with prejudice on grounds that the whistleblower failed to state claims with particularity. It also denied permission to amend the suit on grounds that the whistleblower’s theory premised on alleged violations of the FFDCA and agency regulations failed to state a claim under the FCA.

After briefing on the motion to dismiss was complete, the attorneys say, the Department of Justice filed a statement of interest asking the court not to foreclose the possibility that, under certain circumstances, conduct giving rise to violations of the FFDCA or FDA regulations could be material to the government’s payment decisions and provide a basis for FCA liability.

“While the court acknowledged that a regulatory violation can theoretically rise to the level of creating FCA liability,” the attorneys say, “in a blow to DoJ’s position, the court rejected each of the \[whistleblower’s\] theories premised on violations of the FFDCA and FDA regulations.”

The post concludes that while the court opinion did not foreclose such theories altogether, it is clear that the government/whistleblower must show a strong connection between the regulatory violations and the government’s payment of claims.