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# Sidley Breaks Down Device Whistleblower Case Dismissal
- URL: https://www.fdaweb.com/sidley-breaks-down-device-whistleblower-case-dismissal/
- Published: 2022-07-29T12:00:00.000Z
- Updated: 2026-09-14T17:54:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152404

Law firm Sidley has drawn attention to a recent southern Florida federal court dismissal of a whistleblower lawsuit that declined to “embrace the arguments asserted in a Statement of Interest filed by Department of Justice (DoJ).” In a [post](https://fcablog.sidley.com/court-rejects-tenuous-connection-between-fdca-regulatory-violations-and-claims-for-payment/?ref=fdaweb.com) on Sidley’s False Claims Act (FCA) blog, the law firm examined *United States ex rel. Crocano v. Trividia Health Inc.* that involved defective glucose test strips. The DoJ argued in its statement that “deficiencies in \[an\] affected product resulting from \[Food, Drug & Cosmetic Act\] FDCA violations may, in certain circumstances, be material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.” In rejecting the government’s position, the court reiterated that “the False Claims Act is not the proper avenue for holding \[companies\] accountable” for violations of the FDCA, because “the FDA’s use of its regulatory enforcement powers may be exercised fully to ensure further compliance.”

Sidley noted that DoJ also encouraged the court to conclude that where fraudulent statements or omissions would have caused FDA to recall a product, claims for that product are “false” under the FCA. “This so-called ‘fraud-on-the-FDA’ theory has been received with mixed success in courts, as discussed [**here**](https://fcablog.sidley.com/ninth-circuit-revives-fca-claim-based-on-fraud-on-the-fda/?ref=fdaweb.com) and [**here**](https://fcablog.sidley.com/first-circuit-reins-in-fraud-on-the-fda-theory/?ref=fdaweb.com),” Sidley said.

Sidley pointed out that in its [order](https://fcablog.sidley.com/wp-content/uploads/2022/07/Trividia-Order.pdf?ref=fdaweb.com) granting the defendant’s motion to dismiss, the court agreed that “a regulatory violation can rise to the level of creating liability” under the FCA. “However, the court explained that regulatory violations under the FDCA cannot create FCA liability where the ‘connection to claims for payment by the government is tenuous at best.’ And here, the relator’s argument ‘falls apart’ because even if the defendant’s products were misbranded, the court explained that the relator could not ‘clos\[e\] the circuit between misbranding and claims for reimbursement from the government.’” 

Sidley said the court relied heavily on the Fourth Circuit’s reasoning in *Rostholder* (discussed earlier by the law firm [**here**](https://fcablog.sidley.com/court-rejects-false-statements-to-fda-regarding-cgmp-compliance-as-basis-for-fca-liability/?ref=fdaweb.com)and [**here**](https://fcablog.sidley.com/4th-circuit-affirms-dismissal-of-fca-suit-premised-on-alleged-violations-of-fda-gmp-regulations/?ref=fdaweb.com)). “The district court concluded that as in *Rostholder*, the relator in this case failed adequately to plead falsity because she could not identify a connection between adverse event reporting rules and eligibility for reimbursement; there was no express false certification submitted by the defendant because ‘compliance with FDA regulations is not required for payment by Medicare and Medicaid’; and the relator did not identify ‘any false statement or other fraudulent misrepresentation that Defendant made to the government,’” Sidley said.

Additionally, Sidley noted that the defendant’s alleged misconduct was publicly disclosed and well known to FDA. The agency’s “knowledge seemingly fueled the district court’s significant reservations over allowing relators and DoJ to usurp FDA’s enforcement powers through the FCA,” the law firm said. “This decision represents an important development in the evolving landscape around the intersection between FDCA violations and the False Claims Act.”