United States Ex Rel. Campie v. Gilead Sciences, Inc. ( 2017 )


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  •                     FOR PUBLICATION
    UNITED STATES COURT OF APPEALS
    FOR THE NINTH CIRCUIT
    UNITED STATES OF AMERICA EX                     No. 15-16380
    REL. JEFFREY CAMPIE and SHERILYN
    CAMPIE,                                           D.C. No.
    Plaintiffs-Appellants,           3:11-cv-00941-
    EMC
    v.
    GILEAD SCIENCES, INC.,                            OPINION
    Defendant-Appellee.
    Appeal from the United States District Court
    for the Northern District of California
    Edward M. Chen, District Judge, Presiding
    Argued and Submitted April 19, 2017
    San Francisco, California
    Filed July 7, 2017
    Before: Stephen Reinhardt and A. Wallace Tashima,
    Circuit Judges and Donald W. Molloy,* District Judge.
    Opinion by Judge Molloy
    *
    The Honorable Donald W. Molloy, District Judge for the U.S.
    District Court for the District of Montana, sitting by designation.
    2 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    SUMMARY**
    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
    **
    This summary constitutes no part of the opinion of the court. It has
    been prepared by court staff for the convenience of the reader.
    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).
    COUNSEL
    Tejinder Singh (argued) and Thomas C. Goldstein, Goldstein
    & Russell P.C., Bethesda, Maryland; Andrew S. Friedman
    and Francis J. Balint, Jr., Bonnett Fairbourn Friedman &
    Balint P.C., Phoenix, Arizona; Ingrid M. Evans and Michael
    A. Levy, Evans Law Firm Inc., San Francisco, California; for
    Plaintiffs-Appellants.
    Ethan M. Posner (argued) and Joshua N. DeBold,
    Washington, D.C.; Gretchen Hoff Varner, Covington &
    Burlington LLP, San Francisco, California; for Defendant-
    Appellee.
    Douglas N. Letter (argued ), Benjamin Schultz, and Michael
    S. Raab, Attorneys, Appellate Staff; Brian Stretch, Acting
    United States Attorney; Benjamin Mizer, Principal Deputy
    Assistant Attorney General; Civil Division, United States
    Department of Justice, Washington, D.C.; for Amicus Curiae
    United States.
    4 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    Charles S. Siegel, Waters & Kraus LLC, Dallas, Texas, for
    Amicus Curiae Professor Peter Linzer.
    OPINION
    MOLLOY, District Judge:
    This case involves allegations under the False Claims Act,
    31 U.S.C. §§ 3729–33, that Defendant-Appellee Gilead
    Sciences, Inc. (Gilead) made false statements about its
    compliance with Food and Drug Administration (FDA)
    regulations regarding certain HIV drugs, resulting in the
    receipt of billions of dollars from the government. Relators
    Jeff and Sherilyn Campie (relators), two former Gilead
    employees, allege that these noncompliant drugs were not
    eligible to receive payment or reimbursement and, therefore,
    any claims presented to the government for payment were
    false under the False Claims Act. Relators further allege that
    Gilead violated the False Claims Act when it fired relator Jeff
    Campie, who discovered and ultimately reported the
    violations. See 31 U.S.C. § 3730(h). The district court
    dismissed relators’ claims under Federal Rule of Civil
    Procedure 12(b)(6). It did so before the Supreme Court
    decided Universal Health Servs., Inc. v. United States
    (Escobar), ___ U.S. ___, 
    136 S. Ct. 1989
    (2016). We
    reverse.
    I.
    Gilead is a large drug producer, with a majority of its
    prescription drug product sales occurring in the United States.
    Relevant here, Gilead produces anti-HIV drug therapies,
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 5
    including the drugs Atripla, Truvada, and Emtriva. In 2008
    and 2009 alone, the government spent over $5 billion on
    these anti-retrovirals. Relators claim that in its sale of these
    drugs to the government, Gilead concealed violations of FDA
    regulations and knowingly made false statements regarding
    its regulatory compliance. The facts recited in the relators’
    complaints, which are taken as true at this stage, 
    Escobar, 136 S. Ct. at 1997
    , are as follows.
    When a drug manufacturer wishes to get a drug approved
    for manufacture and sale in the United States, it must submit
    a “new drug application” (NDA) to the FDA, in which it
    states the chemical composition of a drug and specifies the
    facilities where it will be manufactured, as well as methods
    and controls used in the manufacturing process. 21 U.S.C.
    § 355(a), (b)(1); 21 C.F.R. § 314.50(d)(1). Acceptable
    facilities must meet federal standards, known as “good
    manufacturing practices.” See 21 C.F.R. Parts 210, 211. The
    FDA may refuse an application or withdraw a previously
    approved application if the methods or facilities “are
    inadequate to preserve [the drug’s] identity, strength, quality,
    and purity.” 21 U.S.C. § 355(d), (e). Once approved, the
    manufacturer must obtain FDA approval to make major
    changes to the manufacturing process “before the distribution
    of the drug” by submitting an application called a Prior
    Approval Supplement, or PAS. 21 U.S.C. § 356a(c)(2);
    21 C.F.R. § 314.70(b)(3). Both an NDA and PAS require the
    applicant to certify that all statements in the application are
    true and agree to comply with all applicable laws and
    regulations. See Form 356h.
    In the mid-2000s, Gilead submitted NDAs and received
    FDA approval for Emtriva, Truvada, and Atripla. These
    6 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    drugs contain the active ingredient1 emtricitabine (commonly
    known as FTC).2 In its NDA applications, Gilead represented
    to the FDA that it would source the FTC from specific
    registered facilities in Canada, Germany, the United States,
    and South Korea. But, relators allege that as early as 2006,
    Gilead contracted with Synthetics China to manufacture
    unapproved FTC at unregistered facilities. For a period of
    sixteen months beginning in December 2007, Gilead brought
    illicit FTC from a Synthetics China facility into the United
    States to use in its commercial drugs, claiming that the FTC
    had come from its approved South Korean manufacturer.
    Gilead allegedly began using Synthetics China to save money
    and trigger price reduction clauses in contracts with other
    FTC suppliers.
    Gilead ultimately sought approval from the FDA to use
    Synthetics China’s FTC in October 2008, but according to
    relators, Gilead had been including products from Synthetics
    China in its finished drug products for at least two years
    before this approval was obtained in 2010. Relators also
    allege that Gilead falsified or concealed data in support of its
    application to get Synthetics China approved by the FDA.
    For example, Gilead claims in its application that it had
    received three full-commercial-scale batches of FTC from
    Synthetics China that passed testing and were consistent with
    1
    The term “active ingredient” refers to the biologically active
    component of a drug, i.e., any “component that is intended to furnish
    pharmacological activity or other direct effect in the diagnosis, cure,
    mitigation, treatment, or prevention of disease, or to affect the structure of
    any function of the body.” 21 C.F.R. § 210.3(b)(7).
    2
    In addition to using the term FTC, relators use the term “API” to
    refer to “active pharmaceutical products” throughout their complaints. To
    avoid confusion, this opinion uses only the term FTC.
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 7
    or equivalent to FTC batches made from existing, approved
    manufacturers. Relators contend that this representation was
    false as two of three batches had failed internal testing. One
    of the batches purportedly contained “residual solvent levels
    in excess of established limits” and other impurities. A
    second batch had “microbial contamination” and showed the
    presence of arsenic, chromium and nickel contaminants.
    Gilead did not report this to the FDA, but rather secured two
    new batches from the unapproved Chinese site and amended
    its PAS on April 24, 2009, to include the substitute data. The
    FDA approved the amended PAS in May 2009 and the
    Synthetics China facility was registered in 2010. Gilead also
    began using FTC from another, unapproved Synthetics China
    facility, but ultimately stopped using Synthetics China as a
    supplier in October 2011, following continued contamination
    issues. Two recalls of contaminated products occurred in
    2014.
    Gilead never acknowledged or notified the FDA about the
    bad test results or the contamination and adulteration
    problems. Despite being aware of manufacturing problems
    with Synthetics China, Gilead allegedly released 77 lots of
    FTC produced by Synthetics China to its contract
    manufacturers before the FDA approval of the Synthetics
    China facility. Relators allege that the drug products made
    with FTC affecting the quality and purity of the drug and
    produced at a different, uninspected manufacturing site are
    not FDA-approved. And, according to relators, had the FDA
    been aware of these issues, it would not have approved the
    use of the Synthetics China manufacturing facility. Relators
    make a similar argument for the use of unapproved sites in
    Alberta, Canada to produce ambrisentan, the active ingredient
    in Letairis, and contamination of tenofovir disoproxil
    fumarate (a.k.a. Viread), another active ingredient.
    8 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    Relators insist that Gilead actively concealed its use of
    illicit FTC products by Synthetics China in a number of ways.
    First, Gilead imported the FTC through its Canadian facilities
    and used fraudulent labeling. Second, the labels and
    paperwork for the FTC were obscured or augmented to
    conceal where the FTC was actually produced. Third, Gilead
    credited its approved FTC manufacturers with the production
    of the Synthetics China FTC. Relators allege Gilead’s false
    statements and fraudulent conduct resulted in government
    payments both directly, through programs such as the
    Department of Defense, Department of Veterans Affairs,
    Federal Bureau of Prisons, USAID, and the Public Health
    Service, and through reimbursement programs, such as
    Medicare, Medicaid, TRICARE, FEHBP, and the Ryan White
    Program. Payment for drugs under these programs is
    contingent upon FDA approval. See, e.g., 48 C.F.R. § 46.408
    (direct payment); 42 U.S.C. § 1396r-8(k)(2)(A)(i)
    (Medicaid); 42 U.S.C. § 1395w-102(e) (Medicare Part D).
    Relators allege that because the drugs paid for by the
    government contained FTC sourced at unregistered facilities,
    they were not FDA approved and therefore not eligible for
    payment under the government programs.
    Relators further claim that these drugs were “adulterated”
    or “misbranded” in violation of the law. Congress expressly
    prohibits any person from introducing or receiving any
    “adulterated” or “misbranded” drugs in interstate commerce.
    21 U.S.C. § 331(a), (c). A drug is “adulterated” if “the
    methods used in, or the facilities or controls used for, its
    manufacture, processing, packing, or holding do not conform
    to or are not operated or administered in conformity with
    current good manufacturing practice,” or if “any substance
    has been (1) mixed or packed therewith so as to reduce its
    quality or strength or (2) substituted wholly or in part
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 9
    therefor.” 21 U.S.C. § 351(a)(2)(B), (d). A drug is
    “misbranded” if, inter alia, “it is an imitation of another
    drug,” or “it was manufactured, prepared, propagated,
    compounded, or processed in an establishment not duly
    registered” under the Food, Drug, and Cosmetic Act.
    21 U.S.C. § 352(i)(2), (o). Violations of that restriction are
    crimes and adulterated or misbranded drugs can be seized.
    21 U.S.C. §§ 333(a), 334.
    Relators finally raise a retaliation claim regarding the
    termination of Relator Jeff Campie. See 31 U.S.C. § 3730(h).
    Mr. Campie worked at Gilead as its Senior Director of Global
    Quality Assurance from July 2006 to July 2009. His “regular
    job duties focused on commercial drug product quality
    assurance/control issues[, but] he was (based on job
    requirements) expected to review [active ingredient]
    submissions as well.” While employed with Gilead, Campie
    had quality control oversight of (1) all commercially released
    drug products by Gilead; (2) Gilead’s policies, practices, and
    good manufacturing practice compliance; and (3) the
    development of quality systems. It appears that Campie
    raised concerns about “the integrity of the data being
    generated to support the release of Gilead drugs” as early as
    July 2007. In 2008, Campie became worried about Gilead’s
    use of FTC manufactured by Synthetics China, and in January
    2009, convened a meeting to caution Gilead management that
    FTC could not be shipped from an unapproved manufacturing
    site. Through the remainder of his employment, “Mr. Campie
    continued to voice strenuous objections to the false
    representations and omissions being made to the Government
    concerning the source and lack of purity of the [active
    ingredients] from Synthetics China and that [sic] lack of a
    truthful, valid and approved PAS.” “Although Mr. Campie
    was supposed to be responsible for commercial quality input
    10 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    on regulatory filings implicating quality or supply issues,
    Gilead began to selectively circumvent Mr. Campie’s review
    and effectively removed or excluded him from Gilead’s
    regulatory review process.” In a March 2009 meeting, “Mr.
    Campie made clear that he expected Gilead to stop its
    deceptive practices and threatened to inform the FDA if
    Gilead continued its fraudulent conduct.” In April 2009,
    Campie initiated a quarantine to prevent non-approved
    Letairis from entering the supply chain. That quarantine was
    lifted and Campie was chastised by management. During this
    time, Campie continued to voice his concerns.
    On June 20, 2009, Campie was informed he would be
    terminated effective July 2009. He was told that his “heart
    wasn’t in the job anymore.” Campie maintains, however, that
    he was terminated because he “discovered, investigated, and
    raised concerns over Gilead’s release and distribution . . . of
    tons of contaminated and adulterated [active ingredients] that
    had been manufactured at unregistered and uninspected”
    facilities and thus “were not eligible for payment under the
    Government Payment Programs, causing the submission of
    false claims paid by the [federal] Government and the States.”
    Upon termination, Campie was asked to sign a severance
    agreement agreeing not to initiate any claims under the False
    Claims Act. He refused.
    The district court dismissed relators’ first amended
    complaint on January 7, 2015, under Federal Rule of Civil
    Procedure 12(b)(6) for failure to state a claim, but gave
    relators an opportunity to amend. On June 12, 2015, the
    district court dismissed relators’ second amended complaint
    with prejudice, holding that it also failed to state a claim
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 11
    under the False Claims Act.3 Relators timely appealed.
    Although it declined to intervene in the case below, the
    United States Department of Justice submitted a brief as
    amicus curiae supporting reversal of the district court.
    II.
    We have jurisdiction pursuant to 28 U.S.C. § 1291. We
    review the dismissal of claims under the False Claims Act de
    novo. United States ex rel. Hendow v. Univ. of Phx.,
    
    461 F.3d 1166
    , 1170 (9th Cir. 2006). We assume the facts as
    alleged are true and examine only whether relators’
    allegations support a cause of action under the False Claims
    Act under the theories presented. 
    Id. A Rule
    12(b)(6)
    dismissal “can be based on a lack of a cognizable legal theory
    or the absence of sufficient facts alleged under a cognizable
    legal theory.” Balistreri v. Pacifica Police Dep’t, 
    901 F.2d 696
    , 699 (9th Cir. 1990). A complaint must plead “sufficient
    factual matter, accepted as true, to ‘state a claim to relief that
    is plausible on its face.’” Ashcroft v. Iqbal, 
    556 U.S. 662
    , 678
    (2009) (quoting Bell Atl. Corp. v. Twombly, 
    550 U.S. 544
    ,
    570 (2007)). A claim under the False Claims Act must not
    only be plausible, Fed. R. Civ. P. 8(a), but pled with
    particularity under Rule 9(b), Cafassao ex rel. United States
    v. Gen. Dynamics C4 Sys., Inc., 
    637 F.3d 1047
    , 1054–55 (9th
    Cir. 2011). The district court based its dismissal on Rule
    12(b)(6) and did not address whether the relators’ complaints
    met Rule 9(b)’s heightened pleading standard.
    3
    The parallel state claims were dismissed without prejudice.
    12 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    III.
    The False Claims Act makes liable anyone who
    “knowingly presents, or causes to be presented, a false or
    fraudulent claim for payment or approval,” or “knowingly
    makes, uses, or causes to be made or used, a false record or
    statement material to a false or fraudulent claim.” 31 U.S.C.
    § 3729(a)(1)(A), (B). A “claim” includes direct requests for
    government payment as well as reimbursement requests made
    to the recipients of federal funds under a federal benefits
    program. 31 U.S.C. § 3729(b)(2)(A); Escobar,136 S. Ct. at
    1996. A claim under the False Claims Act requires a showing
    of “(1) a false statement or fraudulent course of conduct,
    (2) made with the scienter, (3) that was material, causing
    (4) the government to pay out money or forfeit moneys due.”
    
    Hendow, 461 F.3d at 1174
    . It is not enough to allege
    regulatory violations, United States ex rel. Hopper v. Anton,
    
    91 F.3d 1261
    , 1266 (9th Cir. 1996); rather, the false claim or
    statement must be the “sine qua non of receipt of state
    funding,” Ebied ex rel. United States v. Lungwitz, 
    616 F.3d 993
    , 998 (9th Cir. 2010). We construe the Act broadly, as it
    is “intended to reach all types of fraud, without qualification,
    that might result in financial loss to the Government.”
    
    Hendow, 461 F.3d at 1170
    (quoting United States v. Neifert-
    White Co., 
    390 U.S. 228
    , 232 (1968)).4 Such broad
    4
    Although the Supreme Court admonished in Escobar that “[t]he
    False Claims Act is not ‘an all-purpose antifraud statute,’ or a vehicle for
    punishing garden variety breaches of contract or regulatory 
    violations,” 136 S. Ct. at 2003
    (quoting Allison Engine Co. v. United States ex rel.
    Sanders, 
    555 U.S. 662
    , 672 (2008) (citation omitted)), this instruction
    related only to the “demanding” materiality requirement of a False Claims
    Act claim, see 
    id., and therefore
    did not displace this court’s obligation to
    construe broadly any theory of liability in which materiality can be
    proven.
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 13
    construction has thus given rise to a number of doctrines “that
    attach potential False Claims Act liability to claims for
    payment that are not explicitly and/or independently false.”
    
    Hendow, 461 F.3d at 1171
    .
    Relators insist that Gilead’s claims seeking payment for
    noncompliant drugs are a basis for liability under the False
    Claims Act for three reasons. First, Gilead charged the
    government for approved drugs, knowing that it had delivered
    unapproved “knock-offs” (factually false certification).
    Second, by selling its drugs to the government and causing
    others to seek reimbursement for them, Gilead implicitly
    certified that the drugs were approved for distribution when
    it knew otherwise (implied false certification). Third, Gilead
    lied to the FDA to secure approval of Chinese facilities,
    making them eligible for government payments (promissory
    fraud). The district court below rejected all three of relators’
    theories for recovery under the False Claims Act. First, the
    district court rejected relators’ formulation of a factually false
    theory based on the provision of nonconforming goods. As
    to relators’ second and third arguments, the district court
    recognized claims brought under either an implied false
    certification or promissory fraud theory could be viable, but
    concluded that relators failed to state a claim under either one
    because they failed to allege Gilead made a false statement
    related to a material precondition for payment. The United
    States, while not taking a position on the merits of relators’
    claims, identifies in its amicus briefing two rulings by the
    district court as particularly significant to the government.
    First, it argues that the district court’s dismissal of relators’
    nonconforming goods theory improperly limits liability under
    the False Claims Act. Second, it argues that the district court
    improperly rejected a promissory fraud theory where the
    fraud was initially directed at a non-payor agency. We
    14 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    address each of the relevant theories for recovery under the
    False Claims Act and conclude that relators state a plausible
    claim.
    A. Factually False Certification
    Relators insist that Gilead’s HIV drugs were not
    manufactured at an approved facility and thus were not
    approved by the FDA, and therefore Gilead’s sale of those
    medicines, and attendant receipt of government payments,
    constituted a material false statement. Although the district
    court analyzed this claim in part as a failed claim for
    worthless services, United States ex rel. Lee v. SmithKline
    Beecham, Inc., 
    245 F.3d 1048
    , 1053 (9th Cir. 2001), the claim
    is one of nonconforming goods, United States v. Nat’l
    Wholesalers, 
    236 F.2d 944
    , 950 (9th 1956); see United States
    ex rel. Wilkins v. United Health Group, Inc., 
    659 F.3d 295
    ,
    305 (3d Cir. 2011) (“A claim is factually false when the
    claimant misrepresents what goods or services that it
    provided to the Government . . . .”). The value of the goods
    at issue is dispositive under the first characterization, 
    Lee, 245 F.3d at 1053
    –54, and immaterial to the latter, Nat’l
    
    Wholesalers, 236 F.2d at 949
    –51 (finding a violation of the
    False Claims Act despite substitute goods of “equal”
    performance); United States v. Aerodex, Inc., 
    469 F.2d 1003
    ,
    1007–08 (5th Cir. 1972) (“The mere fact that the item
    supplied under contract is as good as the one contracted for
    does not relieve defendants of liability if it can be shown that
    they attempted to deceive the government agency.”).
    Although relators failed to allege that the drugs paid for by
    the government were “worthless,” that failure does not affect
    relators’ claim for nonconforming goods.
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 15
    In National Wholesalers, a wholesaler contracted with the
    United States to furnish proprietary engine regulators but
    instead delivered regulators manufactured by the wholesaler
    bearing spurious proprietary 
    labels. 236 F.2d at 945
    –47.
    Even though the substitute regulators functioned equally to
    those contracted for, we found liability under the False
    Claims Act because the wholesaler “misbrand[ed]” the
    substitutes to make them appear to be the genuine article. 
    Id. at 950.
    The Fifth Circuit reached a similar conclusion in
    Aerodex, where the defendants sold the United States Navy
    engine bearings different from the ones contracted for,
    admitting that they both reworked and renumbered the
    bearings to appear compliant with their 
    contract. 469 F.2d at 1007
    . Despite the fact that the bearings provided were also
    approved for use in the engines at issue, the Fifth Circuit
    found liability under the False Claims Act due to the
    defendant’s deliberate mislabeling. 
    Id. at 1007–08.
    Contrary to the position taken by Gilead, a claim for
    nonconforming goods is not limited to situations where there
    is an express specification in a payment contract between a
    supplier and the government regarding the disputed aspect of
    the product to be supplied. Such a circumscribed view of
    False Claims Act liability was expressly rejected by the
    Supreme Court in 
    Escobar, 136 S. Ct. at 2001
    , a case decided
    after the district court had ruled in this case. Additionally, as
    we have previously explained, the False Claims Act “was
    enacted during the Civil War with the purpose of forfending
    widespread fraud by government contractors who were
    submitting inflated invoices and shipping faulty goods to the
    government.” 
    Hopper, 91 F.3d at 1265
    –66. That core
    purpose would not be served if a defendant could escape
    liability for delivering nonconforming goods merely because
    the goods retained some value or in the absence of a bilateral
    16 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    contract. It is fraudulent conduct that gives rise to liability,
    regardless of whether the underlying relationship is based in
    contract, regulation, or statute. Nat’l 
    Wholesalers, 236 F.2d at 950
    .
    As we have previously held, the provision of
    nonconforming goods can be a basis of liability under the
    False Claims Act. See 
    Hopper, 91 F.3d at 1266
    (citing
    Aerodex for proposition that “[False Claims Act] actions have
    also been sustained under theories of supplying substandard
    products or services”). But, unlike the situation in Lee, where
    a claim for medically “worthless” drugs does not require a
    showing of “false 
    certification,” 245 F.3d at 1053
    , a claim for
    nonconforming goods must include an intentionally false
    statement or fraudulent course of conduct that was material
    to the government’s decision to pay, Nat’l 
    Wholesalers, 236 F.2d at 950
    .
    B. Implied False Certification
    Claims under an implied false certification theory can
    also be viable under the False Claims Act. Escobar, 136 S.
    Ct. at 1999. Under such a theory, “when a defendant submits
    a claim, it impliedly certifies compliance with all conditions
    of payment. But if the claim fails to disclose the defendant’s
    violation of a material statutory, regulatory, or contractual
    requirement . . . the defendant has made a misrepresentation
    that renders the claim ‘false or fraudulent’ under
    § 3729(a)(1)(A).” 
    Id. at 1995.
    In Escobar, the Supreme
    Court recently “clarif[ied] some of the circumstances in
    which the False Claims Act imposes liability” under this
    theory. 
    Id. As pointed
    out above, the district court did not
    have the benefit of Escobar in making its decision.
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 17
    In Escobar, parents brought suit following the death of
    their daughter after she was treated at a mental health clinic
    by various unlicensed and unsupervised staff in violation of
    state Medicaid regulations. 
    Id. at 1997.
    The operative
    complaint asserted that the healthcare provider “submitted
    reimbursement claims that made representations about the
    specific services provided by specific types of professionals,
    but that failed to disclose serious violations of regulations
    pertaining to staff qualifications and licensing requirements
    for those services.” 
    Id. at 1997–98
    (footnote omitted). The
    state Medicaid program, “unaware of these deficiencies, paid
    the claims.” 
    Id. at 1998.
    The Court concluded that “by
    submitting claims for payment using payment codes that
    corresponded to specific counseling services, [the healthcare
    provider] represented that it had provided individual therapy,
    family therapy, preventive medication counseling, and other
    types of treatment.” 
    Id. at 2000.
    Moreover, staff members
    “submitt[ed] Medicaid reimbursement claims by using
    National Provider Identification numbers corresponding to
    specific job titles. And these representations were clearly
    misleading in context.” 
    Id. The Supreme
    Court held that although the implied
    certification theory can be a basis for liability, two conditions
    must be satisfied. 
    Id. at 2000.
    First, the claim must not
    merely request payment, but also make specific
    representations about the goods or services provided. 
    Id. Second, the
    defendant’s failure to disclose noncompliance
    with material statutory, regulatory, or contractual
    requirements must “make[] those representations misleading
    half-truths.” 
    Id. at 2001
    (footnote omitted). The violation
    need not be of a contractual, statutory, or regulatory provision
    that the Government expressly designated as a condition of
    payment. 
    Id. However, the
    misrepresentation must be
    18 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    “material to the Government’s payment decision.” 
    Id. at 2002.
    Although Escobar clarifies the conditions upon which
    an implied false certification claim can be made, the four
    essential elements identified above remain the same. See
    
    Hendow, 461 F.3d at 1174
    ; see also United States ex rel.
    Kelly v. Serco, Inc., 
    846 F.3d 325
    , 332–33 (9th Cir. 2017)
    (applying Escobar to former employee of a defense
    contractor alleging that his employer’s submission of
    vouchers constituted a false certification of work performed
    under a contract).
    C. Promissory Fraud
    Another approach to finding liability under the False
    Claims Act in the absence of an explicitly false claim is the
    “promissory fraud” or “fraud-in-the-inducement” theory.
    
    Hendow, 461 F.3d at 1173
    . Under this theory, “liability will
    attach to each claim submitted to the government under a
    contract, when the contract or extension of the government
    benefit was originally obtained through false statements or
    fraudulent conduct.” 
    Id. “In other
    words, subsequent claims
    are false because of an original fraud (whether a certification
    or otherwise).” 
    Id. The elements
    of a claim for promissory
    fraud are very similar to those necessary for an implied false
    certification claim, requiring a false claim wherein the falsity
    is knowingly perpetrated and the underlying fraud is material
    to the government’s decision to pay. 
    Id. at 1174.
    D. Elements
    Under all three theories the essential elements of False
    Claims Act liability are: (1) a false statement or fraudulent
    course of conduct, (2) made with scienter, (3) that was
    material, causing (4) the government to pay out money or
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 19
    forfeit moneys due. 
    Escobar, 136 S. Ct. at 2000
    –02; Nat’l
    
    Wholesalers, 236 F.2d at 950
    ; 
    Hendow, 461 F.3d at 1174
    .
    Here, the dispute focuses primarily on the first and third
    elements, falsity and materiality. The district court rejected
    relators’ claims for a number of reasons, including that the
    fraud was directed at the FDA, not the payor agency;
    payment was not conditioned on compliance with FDA
    regulations, but merely FDA approval; and the False Claims
    Act was not meant to intrude on the FDA’s complex
    regulatory regime.
    1. Falsity
    The first requirement of a False Claims Act claim is a
    false claim. 
    Hendow, 461 F.3d at 1171
    ; 
    Hopper, 91 F.3d at 1266
    (“Violations of laws, rules, or regulations alone do not
    create a cause of action. It is the false certification of
    compliance which creates liability when certification is a
    prerequisite to obtaining a government benefit.”). Relators
    allege a false claim here.
    a. Factually false certification
    Relators have adequately satisfied the falsity requirement
    under a theory of factually false certification. As in National
    Wholesalers, Gilead committed factually false certification by
    supplying “misbrand[ed]” 
    goods. 236 F.2d at 950
    .
    Specifically, Gilead represented to the FDA that its active
    ingredients had been manufactured in approved facilities that
    had been registered therewith.
    20 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    b. Implied false certification
    Relators have also adequately satisfied the falsity
    requirement under a theory of implied false certification. To
    succeed on such a claim, pursuant to National Wholesalers
    and Escobar, Gilead must not merely request payment, but
    also make specific representations about the goods or services
    provided. 
    Escobar, 136 S. Ct. at 2000
    ; Nat’l 
    Wholesalers, 236 F.2d at 950
    . Here, relators allege that by submitting
    claims for payment or reimbursement for Truvada, Emtriva,
    and Atripla, Gilead represented that it provided medications
    approved by the FDA that were manufactured at approved
    facilities and were not adulterated or misbranded. Just as
    payment codes correspond to specific health services,
    
    Escobar, 136 S. Ct. at 2000
    , and proprietary labels indicate
    that engine regulators are a proprietary design, Nat’l
    
    Wholesalers, 236 F.2d at 950
    , these drug names necessarily
    refer to specific drugs under the FDA’s regulatory regime.
    Escobar further requires that Gilead’s failure to disclose
    noncompliance with material statutory, regulatory, or
    contractual requirements must “make[] those representations
    misleading 
    half-truths.” 136 S. Ct. at 2000
    (footnote
    omitted). Setting aside the question of materiality, relators
    allege Gilead’s representations were misleading in this
    context because Gilead acquired unapproved FTC from a
    Chinese supplier, re-labeled it to conceal its true nature,
    falsified test results that showed it was contaminated, and
    then used that unapproved and contaminated FTC in drugs for
    which payment was requested and received. Although the
    drugs at issue were at all times ostensibly “FDA approved,”
    relators allege Gilead requested payment for drugs that fell
    outside of that approval and omitted critical information
    regarding compliance with FDA standards.
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 21
    The district court rejected relators’ claims in part because
    the alleged fraud was directed at the FDA, not the payor
    agency. That concern is factually assuaged to some degree
    for the purposes of this case in that both the FDA and the
    Center for Medicare & Medicaid Services (CMS) (the
    primary payor agency for reimbursement claims) are
    overseen by the Secretary of Health and Human Services.
    Therefore, the fraud was, at all times, committed against the
    Department of Health and Human Services. But more
    importantly, the False Claims Act imposes no such limitation.
    See 31 U.S.C. § 3729(a)(1)(B) (extending liability to those
    who cause false statements to be used). It is not the
    distinction between the agencies that matters, but rather the
    connection between the regulatory omissions and the claim
    for payment. See United States ex rel. Petratos v. Genentech
    Inc., 
    855 F.3d 481
    , 492 (3d Cir. 2017) (“[O]ur focus here
    should not be whether the alleged fraud deceived the
    prescribing physicians, but rather whether it affected CMS’s
    payment decision.”). As we stated in Hendow, “if a false
    statement is integral to a causal chain leading to payment, it
    is irrelevant how the federal bureaucracy has apportioned the
    statements among layers of 
    paperwork.” 461 F.3d at 1174
    .
    Hendow itself involved false statements submitted to the
    Department of Education where claims were submitted to
    private lenders. 
    Id. at 1169–80;
    see also, e.g., United States
    ex rel. Duxbury v. Ortho Biotech Products, L.P., 
    579 F.3d 12
    ,
    29–30 (1st Cir. 2009) (alleging defendant’s fraud caused
    medical providers to submit false claims); 
    Hutchenson, 647 F.3d at 378
    (similar). Moreover, relators allege that in
    addition to making a number of false and fraudulent
    statements to the FDA, Gilead’s submission of alleged
    unapproved and noncompliant drugs to the payor agencies
    was itself an alleged false certification. 
    Escobar, 136 S. Ct. at 2000
    .
    22 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    The district court also rejected relators’ claims because
    payment was not “conditioned on the falsity.” As made clear
    in Escobar, “‘[I]nstead of adopting a circumscribed view of
    what it means for a claim to be false or fraudulent,’ concerns
    about fair notice and open-ended liability ‘can be effectively
    addressed through strict enforcement of the Act’s materiality
    and scienter 
    requirements.’” 136 S. Ct. at 2002
    (quoting
    United States v. Science Applications Int’l Corp., 
    626 F.3d 1257
    , 1270 (D.C. Cir. 2010)). We therefore address the
    district court’s concern in the context of materiality.
    Gilead insists its certification was not “false” pursuant to
    United States ex rel. Rostholder v. Omnicare, Inc., 
    745 F.3d 694
    , 701–02 (4th Cir. 2014). In Omnicare, the Fourth Circuit
    concluded that
    once a new drug has been approved by the
    FDA and thus qualifies for reimbursement
    under the Medicare and Medicaid statutes, the
    submission of a reimbursement request for
    that drug cannot constitute a “false” claim
    under the [False Claims Act] on the sole basis
    that the drug has been adulterated as a result
    of having been processed in violation of FDA
    safety 
    regulations. 745 F.3d at 701
    –02. In Omnicare, the relator alleged only
    regulatory violations, not a false claim. 
    Id. Although we
    rejected a regulatory violation claim in 
    Hopper, 91 F.3d at 1265
    –67, we have since clarified that the “fatal defect” in that
    case “was not that the claimed infraction was a regulatory
    violation, but that there was a ‘lack of a false claim,’”
    
    Hendow, 461 F.3d at 1171
    ; see also 
    Kelly, 846 F.3d at 333
    (finding no evidence of a “false claim” where dispute was
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 23
    over format of cost reports). Here, relators allege false
    statements permeating the regulatory process. They allege
    Gilead mislabeled and misbranded nonconforming drugs and
    misrepresented its compliance with FDA regulations by
    omitting critical information. They allege that Gilead
    established policies and practices to violate the FDA’s
    regulatory requirements and allege specific instances of such
    violations, such as altering inventory codes, and mislabeling
    or altering shipping and tracking information. All the while,
    Gilead was submitting claims for payment for “FDA
    approved” drugs. Moreover, they allege that Gilead made
    false statements regarding test results in order to get FDA
    approval and thus become eligible for government funds. As
    was the case in Escobar, “[t]he claims in this case do more
    than merely demand payment. They fall squarely within the
    rule that half-truths—representations that state the truth only
    so far as it goes, while omitting critical qualifying
    information—can be actionable misrepresentations.” 136 S.
    Ct. at 2000 (footnote omitted). Relators adequately plead
    falsity under the False Claims Act. To hold otherwise would
    reduce FDA regulations akin to approval of the curate’s egg.
    c. Promissory fraud
    Finally, relators have adequately satisfied the falsity
    requirement under a theory of promissory fraud. Because
    Gilead committed either factually false or impliedly false
    certification through its representations to the FDA and
    labeling of its products, 
    see supra
    , each claim was fraudulent
    even if false representations were not made therein. See
    
    Hendow, 461 F.3d at 1173
    .
    24 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    2. Scienter
    Had Gilead accidentally produced adulterated pills and
    unwittingly shipped them and requested payment from the
    government, the intent requirement under the False Claims
    Act would not be met. That is not the case. Relators allege
    a false statement or course of conduct made knowingly and
    intentionally. See 31 U.S.C. § 3729(b)(1). They allege
    Gilead took internal actions perpetuating its fraud: altering
    test results, batch numbers, and Inventory Control Numbers,
    and representing that nonapproved FTC came from approved
    facilities. They also allege Gilead established practices to
    deceive the government, and repeatedly took actions to hide
    its fraud. In other words, relators allege Gilead provided
    statements to the government that were “intentional, palpable
    lie[s],” made with “knowledge of the falsity and with intent
    to deceive.” 
    Hopper, 91 F.3d at 1265
    , 1267. The scienter
    element is adequately pled.
    3. Materiality
    Under the False Claims Act, a falsehood is material if it
    has “a natural tendency to influence, or be capable of
    influencing, the payment or receipt of money or property.”
    31 U.S.C. § 3729(b)(4). In Escobar, the Supreme Court
    clarified that “[t]he materiality standard is 
    demanding.” 136 S. Ct. at 2003
    . “A misrepresentation cannot be deemed
    material merely because the Government designates
    compliance with a particular statutory, regulatory, or
    contractual requirement of payment. Nor is it sufficient for
    a finding of materiality that the Government would have the
    option to decline to pay if it knew of the defendant’s
    noncompliance.” 
    Id. Materiality also
    “cannot be found
    where noncompliance is minor or insubstantial.” 
    Id. Proof UNITED
    STATES EX REL. CAMPIE V. GILEAD SCIENCES 25
    of materiality can include whether “the Government pays a
    particular claim in full despite its actual knowledge that
    certain requirements were violated.” 
    Id. FDA approval
    is the “the sine qua non” of federal funding
    here. 
    Hendow, 461 F.3d at 1176
    . Eligibility for federal
    funding and reimbursement is conditioned on FDA approval
    under Medicaid, 42 U.S.C. § 1396r-8 (limited to “covered
    outpatient drug,” which is defined as “approved for safety and
    effectiveness as a prescription drug” by the FDA), Medicare,
    42 U.S.C. § 1395w-102e (similar), and the direct payment
    programs identified by relators, 48 C.F.R. § 46.408 (assigning
    FDA responsibility for ensuring quality of drugs purchased
    by agencies). All of these payment programs look to FDA-
    approval as a determination of the “safety and effectiveness”
    of the drugs at issue.5 It is undisputed that at all times
    relevant, the drugs at issue were FDA-approved,6 and that the
    government continues to make direct payments and provide
    reimbursements for the sale of the three drugs. Relators thus
    face an uphill battle in alleging materiality sufficient to
    maintain their claims.
    We note that other courts have cautioned against allowing
    claims under the False Claims Act to wade into the FDA’s
    regulatory regime. See 
    Omnicare, 745 F.3d at 702
    –03;
    5
    Payment can also be conditioned on other aspects of the drug not
    regulated by the FDA, such as whether the product is “reasonable and
    necessary” under Medicare. See 42 U.S.C. § 1395y(a)(1)(A).
    6
    The district court focused extensively on the difference between
    NDA-approval and PAS-approval, ultimately concluding NDA-approval
    was the sole condition of payment. That distinction is not persuasive post-
    Escobar. 
    See 136 S. Ct. at 1999
    .
    26 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    D’Agostino v. ev3, Inc., 
    845 F.3d 1
    , 9 (1st Cir. 2016);7
    
    Petratos, 855 F.3d at 490
    . However, just as it is not the
    purpose of the False Claims Act to ensure regulatory
    compliance, it is not the FDA’s purpose to prevent fraud on
    the government’s fisc. Mere FDA approval cannot preclude
    False Claims Act liability, especially where, as here, the
    alleged false claims procured certain approvals in the first
    instance.8 A conclusion to the contrary would not be
    consistent with Escobar:
    By punishing defendants who submit “false or
    fraudulent claims,” the False Claims Act
    encompasses claims that make fraudulent
    misrepresentations, which include certain
    misleading omissions. When, as here, a
    defendant makes representations in submitting
    a claim but omits its violations of statutory,
    regulatory, or contractual requirements, those
    omissions can be a basis for liability if they
    render the defendant’s representations
    misleading with respect to the goods or
    services provided.
    7
    In D’Agostino, the First Circuit went as far as to conclude that “[t]he
    FDA’s failure actually to withdraw its approval of [a medical device]. . .
    precludes [the relator] from resting his claims on a contention that the
    FDA’s approval was fraudulently obtained” and that “the absence of some
    official agency action confirming its position and judgment in accordance
    with the law renders [a relator]’s fraud-on-the-FDA theory 
    futile.” 845 F.3d at 9
    .
    8
    Take the hypothetical posed by relators: if a reimbursement request
    was submitted for 10 pills of Atripla, but Gilead actually provided 10 pills
    of Tylenol, that request for payment would be undeniably false. Even
    though Tylenol is FDA approved, it is not what the government paid for.
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 
    27 136 S. Ct. at 1999
    . The dispositive question is rather one of
    materiality, which turns on a number of factors:
    when evaluating materiality under the False
    Claims Act, the Government’s decision to
    expressly identify a provision as a condition
    of payment is relevant, but not automatically
    dispositive. Likewise, proof of materiality can
    include, but is not necessarily limited to,
    evidence that the defendant knows that the
    Government consistently refuses to pay
    claims in the mine run of cases based on
    noncompliance with the particular statutory,
    regulatory, or contractual requirement.
    Conversely, 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. Or, if the
    Government regularly pays a particular type
    of claim in full despite actual knowledge that
    certain requirements were violated, and has
    signaled no change in position, that is strong
    evidence that the requirements are not
    material.
    
    Id. at 2003–04.
    Here, Gilead insists that because the government
    continued to pay for the medications after it knew of the FDA
    violations, those violations were not material to its payment
    decision. Relators outline a variety of facts that speak to the
    government’s knowledge, such as a September 2010 warning
    letter regarding impurities in the form of black specks and
    28 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    spots, a June/July 2012 inspection and noncompliance letter
    regarding product from Synthetics China, December 2012
    and July 2013 inspections of a specific facility, and two
    recalls that took place in 2014. Gilead’s argument is
    premised on the continued FDA approval of the drugs even
    after the agency became aware of certain noncompliance.
    Relators and the United States persuasively argue,
    however, that to read too much into the FDA’s continued
    approval—and its effect on the government’s payment
    decision—would be a mistake. First, to do so would allow
    Gilead to use the allegedly fraudulently-obtained FDA
    approval as a shield against liability for fraud. Second, as
    argued by Gilead itself, there are many reasons the FDA may
    choose not to withdraw a drug approval, unrelated to the
    concern that the government paid out billions of dollars for
    nonconforming and adulterated drugs. Third, unlike Kelly,
    where the government continued to accept noncompliant
    
    vouchers, 846 F.3d at 334
    , Gilead ultimately stopped using
    FTC from Synthetics China. Once the unapproved and
    contaminated drugs were no longer being used, the
    government’s decision to keep paying for compliant drugs
    does not have the same significance as if the government
    continued to pay despite continued noncompliance. In
    making its argument, Gilead specifically cites to Petratos,
    where the Third Circuit concluded the materiality standard
    was not met where the relator did “not dispute that CMS
    would reimburse these claims even with full knowledge of
    the alleged reporting 
    deficiencies.” 855 F.3d at 490
    . Beside
    the fact that the relator in Petratos did not allege regulatory
    or statutory violations, 
    id. (“Petratos does
    not claim that [the
    defendant]’s safety-related reporting violated any statute or
    regulation.”), no such concession is made here. Rather, the
    parties dispute exactly what the government knew and when,
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 29
    calling into question its “actual knowledge.” Although it may
    be that the government regularly pays this particular type of
    claim in full despite actual knowledge that certain
    requirements were violated, such evidence is not before us.
    The issues raised by the parties here are matters of proof,
    not legal grounds to dismiss relators’ complaint.9 See 
    Kelly, 846 F.3d at 334
    (concluding relator “failed to establish a
    genuine issue of material fact regarding [] materiality”). And,
    other statutes regulating “adulterated” and “misbranded”
    drugs reinforce the idea that violations of the FDA regulatory
    regime have ramifications beyond FDA enforcement actions.
    See 21 U.S.C. § 331; see, e.g., United States v. Marcus,
    
    82 F.3d 606
    , 610 (4th Cir. 1996) (upholding criminal liability
    for manufacturer’s undisclosed addition of two inactive
    pharmaceutical ingredients not included in FDA-approved
    NDA given their unknown effect on safety and efficacy of the
    drug product).
    In sum, relators allege more than the mere possibility that
    the government would be entitled to refuse payment if it were
    aware of the violations, 
    Kelly, 846 F.3d at 334
    , sufficiently
    pleading materiality at this stage of the case.
    9
    In D’Agostino, the First Circuit highlighted the “[p]ractical problems
    of proof” in how a relator would show that the FDA would not have
    granted approval but for the fraudulent 
    representations. 845 F.3d at 9
    .
    That concern is exactly that: a problem of proof. At the pleading stage we
    assume the facts alleged by the relators to be true. 
    Hendow, 461 F.3d at 1170
    .
    30 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    4. Claim
    Relators allege Gilead submitted false claims in a number
    of ways, including submitting direct requests for payment
    from government agencies, as well as submitting requests for
    reimbursement. Those allegations are sufficient under the
    False Claims Act. 
    Hendow, 461 F.3d at 1177
    .
    Ultimately, relators have alleged sufficient facts under the
    False Claims Act to state a claim for relief that is plausible on
    its face. Fed. R. Civ. P. 8(a); 
    Ashcroft, 556 U.S. at 678
    . We
    do not reach whether that claim is alleged with sufficient
    particularity to meet the requirements of Rule 9(b), as that
    question was not addressed by the district court.
    IV.
    Relator Jeff Campie also alleges Gilead retaliated against
    him in violation of the False Claims Act. 31 U.S.C.
    § 3730(h). To state a claim for retaliation, a plaintiff must
    demonstrate that: (1) he “engaged in activity protected under
    the statute”; (2) the employer knew the plaintiff engaged in a
    protected activity; and (3) the employer discriminated against
    the plaintiff “because he . . . engaged in protected activity.”
    Mendiondo v. Centinela Hosp. Med. Ctr., 
    521 F.3d 1097
    ,
    1103 (9th Cir. 2008) (holding that the heightened pleading
    requirements of Rule 9(b) do not apply). The district court
    dismissed Campie’s retaliation claim, holding that he failed
    to show either that he was engaged in a protected activity or
    that Gilead had notice of such activities. We reverse.
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 31
    A. Protected Activity
    An employee engages in a protected activity by
    “‘investigating matters which are calculated or reasonably
    could lead to a viable [False Claims Act] action.’” Moore v.
    Cal. Inst. of Tech. Jet Propulsion Lab., 
    275 F.3d 838
    , 845
    (9th Cir. 2002) (quoting 
    Hopper, 91 F.3d at 1269
    ). The
    district court relied extensively on Hopper to conclude that
    because Campie’s allegations are consistent with an
    investigation into regulatory noncompliance—as opposed to
    an effort to uncover fraud against the government—he failed
    to show he engaged in a protected activity. 
    See 91 F.3d at 1263
    –65. However, in Moore we subsequently clarified “that
    an employee engages in protected activity where (1) the
    employee in good faith believes, and (2) a reasonable
    employee in the same or similar circumstances might believe,
    that the employer is possibly committing fraud against the
    
    government.” 275 F.3d at 845
    –46 (footnote omitted). The
    Second Amended Complaint sufficiently alleges facts
    showing that Campie had an objectively reasonable, good
    faith belief that Gilead was possibly committing fraud against
    the government.
    B. Notice
    It is not enough for relators to allege that Jeff Campie was
    engaged in a protected activity; they must also show that
    Gilead knew Campie was engaged in such activity.
    
    Mendiondo, 521 F.3d at 1103
    ; 
    Hopper, 91 F.3d at 1269
    . As
    made clear in Mendiondo, an allegation of knowledge is not
    a high bar:
    For the second element of her . . . retaliation
    claims, Mendiondo alleges she complained to
    32 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    [the defendant]’s CEO . . . about possible
    “civil and criminal violations.” Although
    vague, the reference to “civil violations” can
    be construed to include the suspected
    Medicare fraud described above. Because
    Mendiondo complained to [the CEO] about
    the suspected civil violations, [the defendant]
    was informed of Mendiondo’s protected
    
    activity. 521 F.3d at 1104
    . Here, the Second Amended Complaint
    alleges Campie was told it was “none of his concern” when
    he discussed contamination and adulteration problems on
    multiple occasions, and he was asked to sign a severance
    agreement stating he would not bring a False Claims Act
    claim. Further, “Mr. Campie explicitly complained that
    Gilead was violating FDA regulations in order to sell its
    drugs to the Government and States notwithstanding their
    lack of compliance with [regulatory requirements] . . . .”
    These allegations are sufficient under Mendiondo.
    That said, as noted by the district court, the monitoring
    and reporting activities outlined by relators are by-and-large
    the types of activities Campie was required to undertake as
    part of his job. Courts have held that when an employee is
    tasked with such investigations, it takes more than an
    employer’s knowledge of that activity to show that an
    employer was on notice of a potential qui tam suit. See
    United States ex rel. Ramseyer v. Century Healthcare Corp.,
    
    90 F.3d 1514
    , 1523 (10th Cir. 1996) (holding retaliation
    allegation insufficient where plaintiff’s job duties entailed the
    monitoring and reporting activities at issue); see also
    Robertson v. Bell Helicopter Textron, Inc., 
    32 F.3d 948
    , 952
    UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES 33
    (5th Cir. 1994) (concluding that relator failed to rebut
    defendant’s trial testimony regarding lack of knowledge).
    Although Ramseyer is instructive, it is distinct from this
    case. First, the plaintiff in Ramseyer “gave no suggestion that
    she was going to report [the] noncompliance to government
    
    officials.” 90 F.3d at 1523
    . Here, the Second Amended
    Complaint alleges that “Mr. Campie made clear that he
    expected Gilead to stop its deceptive practices and threatened
    to inform the FDA if Gilead continued its fraudulent
    conduct.” Second, Campie alleges he was “selectively
    circumvent[ed]” and “exclud[ed]” from the regulatory review
    process in which he was meant to take part, was told certain
    regulatory compliance actions, such as issuing a quarantine,
    were “not in his job description,” and had conversations
    outside of his chain of command regarding his concerns. The
    Second Amended Complaint alleges sufficient facts to show
    Gilead knew of Campie’s protected activity.
    C. Causation
    Finally, relators’ pleading must show that Gilead
    discriminated against Mr. Campie “because he [] engaged in
    protected activity.” 
    Mendiondo, 521 F.3d at 1104
    . It is
    sufficient at the pleading stage for the plaintiff “to simply
    give notice that []he believes [the defendant] terminated
    h[im] because of h[is] investigation into the practices []
    specified in the complaint.” 
    Id. Although the
    district court
    did not address this requirement because it found the
    operative complaint insufficient under the first two
    requirements, such a showing has been made here.
    34 UNITED STATES EX REL. CAMPIE V. GILEAD SCIENCES
    Based on the forgoing, the retaliation claim included in
    the Second Amended Complaint contains sufficient facts to
    survive dismissal under Rule 12(b)(6).
    V.
    Relators plead sufficient factual allegations to state a
    claim under the False Claims Act. Because the district court
    did not address whether relators’ claims pursuant to 31 U.S.C.
    § 3729(a)(1)(A), (B) meet the heightened pleadings standard
    under Rule 9(b), we decline to decide that question in the first
    instance.
    REVERSED AND REMANDED.