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# Supreme Court Asked to Consider ‘Materiality’ Standard
- URL: https://www.fdaweb.com/supreme-court-asked-to-consider-materiality-standard/
- Published: 2018-01-09T12:00:00.000Z
- Updated: 2026-09-14T23:12:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140450

Gilead has asked the Supreme Court to hear its appeal of a 9th Circuit Court of Appeals decision holding that whether False Claims Act allegations are material raises questions of proof that cannot be resolved through a motion to dismiss. Attorney **Anne Walsh** (Hyman, Phelps & McNamara) [writes](http://www.fdalawblog.net/2018/01/court-may-confirm-the-rigorous-materiality-standard-required-by-the-false-claims-act/?ref=fdaweb.com) in her firm’s *FDA Law Blog* that to prevail on a False Claims Act allegation, a plaintiff must allege that the defendant’s misrepresentation was “material to the government’s payment decision.” In the 2016 *Escobar* case, the Supreme Court said that “if the government pays a particular claim in full despite its actual knowledge that certain requirements were violated, that is very strong evidence that those requirements are not material,” Walsh writes.

In the Gilead case, the 9th Circuit said the plaintiffs “alleged more than the mere possibility that the government would be entitled to refuse payments if it were aware of the violations” and that was sufficient for materiality “at this stage of the case.”

Gilead has said the Supreme Court should hear the case because **(1)** the 9th Circuit’s approach conflicts with decisions of six other circuits that have addressed the same question and interpreted *Escobar* differently; **(2)** courts have had, and will have, to consider this question with frequency, and the case’s outcome could affect the availability of drugs and medical products to the marketplace; and **(3)** the case is well positioned to provide “guidance on a significant and recurring issue by clarifying how the government’s response upon learning of alleged infractions affects the viability of a False Claims Act complaint.”