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# New Theories of False Claims Act Liability
- URL: https://www.fdaweb.com/new-theories-of-false-claims-act-liability/
- Published: 2023-11-29T12:00:00.000Z
- Updated: 2026-09-14T14:17:13.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5155886

Several Skadden attorneys say an increased focus on cybersecurity could pose False Claims Act (FCA) exposure risk for life sciences companies. Writing in a lengthy online [newsletter](https://www.skadden.com/insights/publications/2023/11/the-nucleus?ref=fdaweb.com#increased), the attorneys review FDA’s promotional enforcement update, Warning Letters arising out of inspection activities, and a loss on statutory interpretation.

The report also addresses FDA regulatory issues such as issuance of the long-awaited proposed rule to regulate laboratory-developed tests, the delay in enforcement of electronic interoperable systems to track prescription drugs at the package level, and the final guidance on cybersecurity considerations in premarket submissions for medical devices.

“The False Claims Act remains a familiar tool for litigants seeking to pursue civil liability against life sciences companies,” the attorneys write. “The past decade has seen continued deployment of the FCA in the life sciences space under common theories such as causation of medically unnecessary claims, sales of defective products, and so-called fraud on FDA. There can be little doubt that the Department of Justice (DoJ) and the relators’ bar will continue to pursue and explore cases based on these theories of liability in the years to come.”

But, the attorneys say, a recent FDA and DoJ focus on cybersecurity issues suggests the possibility of new theories of FCA liability, arising at the intersection of already established theories and concerns about cyber fraud.

“Life sciences companies should be aware of that intersection and take steps to minimize their exposure to potential FCA risk by evaluating their cybersecurity risks and implementing appropriate controls,” the authors conclude.