“Request for Payment” Link Reinforced By Recent Federal Ruling

On January 7, 2015, a California federal judge granted an FCA defendant’s Motion to Dismiss premised on allegations that it failed to comply with Good Manufacturing Practices (“cGMPs”) regulations. See U.S. ex rel. Campie v. Gilead Sciences, Inc., No. 11-cv-00941 (N.D. Cal. Jan. 7, 2015). In this case, two former Gilead employees with quality control responsibilities filed a Qui Tam action against their previous employer alleging various violations of cGMP requirements. The relators asserted in their Complaint that they discovered and reported to Gilead officials numerous violations of Federal Food and Drug Administration (“FDA”) regulations, but that Gilead concealed those
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An Important Ninth Circuit Decision on Scope of Liability under the False Claims Act.

In 2014, the Ninth Circuit issued an important decision on the notion that good faith disputes and/or disputed interpretations of contract requirements should not be actionable as false claims. In Gonzalez v. Planned Parenthood, 759 F.3d 1112 (9th Cir. 2014), the relator alleged that the Medi-Cal billing manual required Planned Parenthood to bill Medi-Cal “at cost” for contraceptives; which the relator alleged meant at Planned Parenthood’s acquisition cost. When Planned Parenthood submitted bills to Medi-Cal it billed costs for contraceptives at its “usual and customary rates.” In 1997, the California Department of Healthcare Services, the governing body for Medi-Cal, informed
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