A False Claims Act whistleblower failed to win reinstatement of his suit alleging that Grifols USA and others billed the federal government for autoimmune disorders drug Gamunex based on misrepresentations to the Food and Drug Administration.
Allen Yu asserted that Grifols’ eligibility to provide Gamunex to the government was conditioned on the FDA determining that the drug manufacturing process complied with quality requirements under the Food, Drug, and Cosmetic Act.
But the suit failed for lack of materiality under the FCA because Yu didn’t identify contract provisions that expressly conditioned payments on Grifols’ compliance with those standards, the US Court ...
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