United States ex rel. Campie v. Gilead Sciences, Inc., No. 15-16380 (9th Cir. 2017)
Annotate this CaseRelators filed suit under the False Claims Act (FCA), 31 U.S.C. 3729-33, alleging that Gilead made false statements about its compliance with FDA regulations regarding certain HIV drugs. The Ninth Circuit reversed the district court's dismissal of relators' complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). The panel held that relators stated a plausible claim by alleging factually false certification, implied false certification, and promissory fraud. Furthermore, relators adequately plead scienter, materiality, and that Gilead submitted false claims. The panel reversed the dismissal of the retaliation claim, holding that the Second Amended Complaint sufficiently alleged facts showing that Relator Jeff Campie had an objectively reasonable, good faith belief that Gilead was possibly committing fraud against the government; sufficient facts to show Gilead knew of Campie's protected activity; and causation.
Court Description: False Claims Act. The panel reversed the district court’s Fed. R. Civ. P. 12(b)(6) dismissal of claims under the False Claims Act by relators Jeff and Sherilyn Campie alleging that their former employer, Gilead Sciences, Inc., made false statements about its compliance with Food and Drug Administration regulations regarding certain HIV drugs, resulting in the receipt of billions of dollars from the government; and alleging retaliation against relator Jeff Campie. The panel held that the relators stated a plausible claim that Gilead’s claims seeking payment for noncompliant drugs were a basis for liability under the False Claims Act. Considering the four elements of False Claims Act liability, first, the panel held that relators alleged a “false claim” under theories of factually false certification, implied false certification, and promissory fraud. Second, relators adequately pled “scienter.” Third, the relators sufficiently pled “materiality” at this stage of the case where they alleged more than the mere possibility that the government would be entitled to refuse payment if it were aware of the violations. Fourth, the relators sufficiently alleged that Gilead submitted false claims in a number of ways. The panel held that the relators adequately pled a claim for retaliation in violation of the False Claims Act. Specifically, the panel held that the second amended UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 3 complaint sufficiently alleged facts showing that Jeff Campie had an objectively reasonable, good faith belief that Gilead was possibly committing fraud against the government; that Gilead knew Campie was engaged in protected activity: and that Gilead discriminated against Campie because he engaged in protected activity. The panel declined to decide in the first instance the question of whether relators’ claims pursuant to 31 U.S.C. § 3729(a)(1)(A), (B) met the heightened pleading standard under Fed. R. Civ. P. 9(b).
Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.