Booker v. Pfizer, Inc. , 847 F.3d 52 ( 2017 )


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  •           United States Court of Appeals
    For the First Circuit
    No. 16-1805
    UNITED STATES ex rel. ALEX BOOKER and EDMUND HEBRON,
    Relators, Appellants,
    STATE OF CALIFORNIA; STATE OF COLORADO; STATE OF CONNECTICUT;
    STATE OF DELAWARE; STATE OF FLORIDA; STATE OF GEORGIA; STATE OF
    HAWAII; STATE OF ILLINOIS; STATE OF INDIANA; STATE OF LOUISIANA;
    STATE OF MARYLAND; STATE OF MICHIGAN; STATE OF MINNESOTA; STATE
    OF MONTANA; STATE OF NEW HAMPSHIRE; STATE OF NEW JERSEY; STATE
    OF NEW MEXICO; STATE OF NEW YORK; STATE OF NORTH CAROLINA; STATE
    OF OKLAHOMA; STATE OF RHODE ISLAND; STATE OF TENNESSEE; STATE OF
    TEXAS; STATE OF WISCONSIN; COMMONWEALTH OF MASSACHUSETTS;
    COMMONWEALTH OF VIRGINIA; DISTRICT OF COLUMBIA,
    Plaintiffs,
    v.
    PFIZER, INC.,
    Defendant, Appellee.
    APPEAL FROM THE UNITED STATES DISTRICT COURT
    FOR THE DISTRICT OF MASSACHUSETTS
    [Hon. Douglas P. Woodlock, U.S. District Judge]
    Before
    Lynch, Stahl, and Barron,
    Circuit Judges.
    Kevin J. Darken, with whom The Barry A. Cohen Legal Team,
    Thomas N. Burnham, and Burnham International Law Office were on
    brief, for appellants.
    Kirsten V. Mayer, with whom Brien T. O'Connor, Emily J. Derr,
    Nicholas S. Bradley, and Ropes & Gray LLP were on brief, for
    appellee.
    January 30, 2017
    - 2 -
    LYNCH,   Circuit     Judge.      On    August    31,     2009,    the
    pharmaceutical company Pfizer, Inc. settled various claims that it
    had violated the False Claims Act ("FCA"), 
    31 U.S.C. §§ 3729
     et
    seq., with the U.S. Department of Justice ("DOJ").                    As part of
    that    settlement,    Pfizer     entered    into    a   Corporate     Integrity
    Agreement ("CIA") with the U.S. Department of Health and Human
    Services ("HHS").
    Less than a year after that settlement, relators Alex
    Booker and Edmund Hebron, two former Pfizer sales representatives,
    brought this qui tam action against Pfizer in federal district
    court, alleging it was on behalf of the United States, more than
    two dozen individual states, and the District of Columbia, and
    asserting that despite the settlement, Pfizer had continued to
    engage in conduct prohibited by the FCA and state analogues.                  None
    of the sovereigns elected to intervene.
    Relators filed their original complaint on July 13, 2010
    and amended it several times before the district court denied their
    motion for leave to file a sixth amended complaint.                   Primarily,
    they alleged that Pfizer had continued to knowingly induce third
    parties to file false claims for payment for Pfizer drugs with
    government programs like Medicaid by (1) marketing the drug Geodon
    for off-label uses, in violation of sections 331 and 355 of the
    Food, Drug, and Cosmetic Act ("FDCA"), 
    21 U.S.C. §§ 301
     et seq.;
    and    (2)   paying   kickbacks    to   doctors     to   compensate    them   for
    - 3 -
    prescribing the drugs Geodon and Pristiq, in violation of the Anti-
    Kickback Statute ("AKS"), 42 U.S.C. § 1320a-7b(b), (g).1   Relators
    also alleged that Pfizer had violated the "reverse false claims"
    provision of the FCA, see 
    31 U.S.C. § 3729
    (a)(1)(G), by failing to
    pay the government money owed it under Pfizer's CIA with HHS.
    Finally, relators alleged that Pfizer had violated the FCA's anti-
    retaliation provision, see 
    id.
     § 3730(h), by terminating Booker's
    employment on January 6, 2010, purportedly in response to his
    alleged whistleblowing activities.
    All of these claims were resolved against relators, one
    on a motion to dismiss and the rest on summary judgment.   On March
    26, 2014, the district court granted Pfizer's motion to dismiss
    the claim under the reverse false claims provision (the "reverse
    FCA claim") but allowed relators to proceed to discovery (with
    limits) on the other claims.   See U.S. ex rel. Booker v. Pfizer,
    Inc. ("Booker I"), 
    9 F. Supp. 3d 34
    , 50, 60-61 (D. Mass. 2014).
    On May 23, 2016, the district court granted Pfizer's motion for
    summary judgment on the remaining claims.   See U.S. ex rel. Booker
    v. Pfizer, Inc. ("Booker II"), 
    188 F. Supp. 3d 122
    , 140 (D. Mass.
    1    Off-label uses of a drug that are medically "essential"
    or recognized in certain medical compendia, for which Medicaid
    does reimburse, see 42 U.S.C. § 1396r-8(a)(3), (g)(1)(B)(i),
    (k)(6), are not at issue in this case. See U.S. ex rel. Rost v.
    Pfizer, Inc., 
    507 F.3d 720
    , 723 n.1 (1st Cir. 2007), abrogated on
    other grounds by Allison Engine v. U.S. ex rel. Sanders, 
    553 U.S. 662
     (2008).
    - 4 -
    2016).      Relators appeal the dismissal, the grant of summary
    judgment,      and    certain   of      the    district    court's      intervening
    discovery rulings. We affirm the district court's merits decisions
    and find no error in its management of discovery.
    We rely on the district court's two thorough opinions
    for a basic recounting of the case.                See Booker I, 
    9 F. Supp. 3d 34
    ; Booker II, 
    188 F. Supp. 3d 122
    .                We give only that background
    information needed for this appeal.
    I.    ANALYSIS
    A.   Appeal from Dismissal of Reverse FCA Claim
    1.    Appellate Jurisdiction
    Pfizer wrongly suggests that we have no jurisdiction to
    review   the     district   court's        March   26,   2014   order    dismissing
    relators' reverse FCA claim due to defects in relators' notice of
    appeal. See Fed. R. App. P. 3(c)(1)(B) (a "notice of appeal must[]
    designate the judgment, order, or part thereof being appealed").
    Specifically,        we   reject     the      contention   that    there    is   no
    jurisdiction because relators' notice of appeal did not explicitly
    mention the dismissal order.            While the notice did specify certain
    other orders issued by the district court, it also specified the
    court's May 26, 2016 final judgment disposing of the case, and "it
    has been uniformly held that a notice of appeal that designates
    the final judgment encompasses not only that judgment, but also
    all earlier interlocutory orders that merge in the judgment."
    - 5 -
    John’s Insulation, Inc. v. L. Addison & Assocs., Inc., 
    156 F.3d 101
    , 105 (1st Cir. 1998); see also Ocasio-Hernández v. Fortuño-
    Burset, 
    777 F.3d 1
    , 6 n.12 (1st Cir. 2015).
    2.   Merits of Dismissal of Reverse FCA Claim
    We affirm the district court's dismissal of relators'
    reverse FCA claim on de novo review, albeit on grounds different
    from those relied on by the district court.2         See Otero v.
    Commonwealth of P.R. Indus. Comm'n, 
    441 F.3d 18
    , 20 (1st Cir.
    2006).   We take no position on whether the district court's
    reasoning was correct.
    The reverse false claims provision of the FCA imposes
    liability on anyone who "knowingly conceals or knowingly and
    improperly avoids or decreases an obligation to pay . . . money
    . . . to the Government."    
    31 U.S.C. § 3729
    (a)(1)(G).   The term
    "obligation" is defined by the statute as "an established duty,
    2    The district court reasoned that relators failed to
    plead that Pfizer ever had an "obligation" to pay the government
    because they failed to plead that HHS exercised its right to demand
    payment under the CIA. Booker I, 9 F. Supp. 3d at 50. Relators
    insist that an "obligation" to pay the government arises under the
    CIA as soon as HHS is entitled to demand payment and that they
    pled that Pfizer had such an obligation by virtue of pleading that
    Pfizer failed to report a Reportable Event. They note that two
    district courts have come to this conclusion as to when an
    "obligation" arises under CIAs materially identical to the one at
    issue here. See Ruscher v. Omnicare Inc., No. 4:08-CV-3396, 
    2014 WL 4388726
    , at *5-6 (S.D. Tex. Sept. 5, 2014); U.S. ex rel. Boise
    v. Cephalon, Inc., No. 08-287, 
    2015 WL 4461793
    , at *3-7 (E.D. Pa.
    July 21, 2015).
    - 6 -
    whether     or   not   fixed,    arising      from    an    express   or    implied
    contractual . . . relationship."             
    Id.
     § 3729(b)(3).
    Relators' reverse FCA claim was predicated on Pfizer's
    alleged breach of its obligations under its August 31, 2009 CIA
    with HHS.    The CIA imposed on Pfizer an ongoing duty to report its
    "probable" violations of the FCA to HHS.                   Specifically, the CIA
    defined as a "Reportable Event," inter alia, "a matter that a
    reasonable person would consider a probable violation of . . .
    laws applicable to any FDA requirements relating to the promotion
    of Government Reimbursed Products."              And the CIA provided that
    "[i]f Pfizer determines (after a reasonable opportunity to conduct
    an       appropriate       review       or       investigation         of       the
    allegations) . . . that there is a Reportable Event, Pfizer shall
    notify [HHS] . . . within 30 days after making the determination."3
    Elsewhere, the CIA stated that Pfizer's failure to meet the
    "obligations . . . set forth [above] may lead to the imposition
    of . . . [a] Stipulated Penalty of $2,500 . . . for each day
    Pfizer" is in breach.       The CIA explained that, if HHS finds "that
    Pfizer     has    failed    to      comply     with        [the   aforementioned]
    obligations," and if HHS thereafter "determin[es] that Stipulated
    Penalties are appropriate, [HHS] shall notify Pfizer of . . .
    3    The CIA also provided that "Pfizer shall submit to [HHS]
    annually a report [that] shall include," inter alia, "a summary of
    Reportable Events . . . identified."
    - 7 -
    [HHS's] exercise of its contractual right to demand payment of the
    Stipulated Penalties."
    In their complaint, relators allege that a January 5,
    2010       email   sent   by   Booker   to   Pfizer's    Corporate     Compliance
    Department,        purportedly    claiming      that    Booker's     manager   was
    instructing his subordinates to engage in off-label promotion,
    constituted a "Reportable Event" under the CIA.                    Because Pfizer
    did not report this email to HHS, relators allege, Pfizer illegally
    avoided its "obligation" to pay the CIA’s "stipulated penalt[y]"
    of $2,500 per day for failure to report a "Reportable Event."
    Pfizer argues -- as it did before the district court --
    that relators fail to state a claim for reverse FCA liability
    because Booker's email to the Corporate Compliance Department did
    not constitute a "Reportable Event."              Pfizer points out that the
    "CIA does not require Pfizer to report all complaints" it receives.
    Under the CIA, conduct becomes a "Reportable Event" only "if Pfizer
    determines," after a chance to investigate, that the conduct is a
    "probable violation" of a specific class of laws.                      As Pfizer
    explains, nowhere in their much amended complaint do relators
    allege that Pfizer ever determined Booker's complaint to be in any
    way credible and therefore a "Reportable Event."4
    4       Nor did relators seek reconsideration after discovery.
    - 8 -
    On the record in this case we affirm.         We do not decide
    if, under the CIA, Pfizer's authority to determine whether a
    "Reportable   Event"     occurred      is    subject    to   an   implicit
    reasonableness limitation that prevents Pfizer from shutting its
    eyes to conduct that it abides but that a "reasonable person" would
    think is a "probable violation" of relevant law.         Relators did not
    assert before the district court, nor do they assert on appeal,
    that the agreement should be construed that way and that Pfizer
    acted unreasonably in not determining that Booker's complaint
    constituted a "Reportable Event," so the point is waived.                 As
    relators fail to allege that Pfizer determined that a "Reportable
    Event" occurred, their complaint fails to state a claim for relief.
    We affirm the dismissal on that basis.
    B.   Appeal from Summary Judgment on the Remaining FCA Claims
    Relators    next   appeal   the   district   court's   grant   of
    summary judgment for Pfizer on their off-label promotion and
    retaliation claims under the FCA.5 After reviewing those decisions
    de novo, "drawing all reasonable inferences in [relators'] favor,"
    Feliciano de la Cruz v. El Conquistador Resort & Country Club, 
    218 F.3d 1
    , 5 (1st Cir. 2000), we affirm both.
    5   Relators do not directly appeal the grant of summary
    judgment on their AKS-based FCA claim.       Instead, they bring
    challenges to some of the district court's discovery rulings that
    were germane to that claim. For reasons we explain later, those
    challenges fail.
    - 9 -
    1.   Off-Label Promotion FCA Claim
    Relators sought to prove that after Pfizer resolved its
    FCA liability with the DOJ in 2009 for, inter alia, knowingly
    inducing false claims through off-label promotion in violation of
    
    31 U.S.C. § 3729
    (a)(1)(A), Pfizer continued to induce false claims
    by promoting Geodon for three off-label uses.6    Those three uses
    were (1) as a treatment for children and adolescents, (2) as a
    bipolar maintenance monotherapy drug, and (3) as a treatment for
    any condition at excessive dosages.      Without deciding whether
    relators had provided sufficient evidence of continued off-label
    promotion to survive summary judgment, see Booker II, 188 F. Supp.
    3d at 133 n.4, the district court concluded that relators' proffer
    was fatally devoid of evidence that an "actual false claim" had
    resulted from any such promotion, id. at 129.    We agree.
    It is well settled that "[e]vidence of an actual false
    claim is 'the sine qua non of a False Claims Act violation.'"   U.S.
    ex rel. Karvelas v. Melrose-Wakefield Hosp., 
    360 F.3d 220
    , 225
    (1st Cir. 2004) (citation omitted), abrogated on other grounds by
    Allison Engine, 
    553 U.S. 662
    .   That is, even when a relator can
    prove that a defendant engaged in "fraudulent conduct affecting
    6    Geodon is approved by the Food and Drug Administration
    ("FDA") pursuant to the FDCA as a treatment for "schizophrenia, as
    monotherapy for the acute treatment of bipolar manic or mixed
    episodes, and as an adjunct to lithium or valproate for the
    maintenance treatment of bipolar disorder."
    - 10 -
    the government," FCA liability attaches only if that conduct
    resulted in the filing of a false claim for payment from the
    government.    Rost, 
    507 F.3d at 727
    .               Because claims of fraud are
    involved, even at the pleading stage relators are required under
    Fed. R. Civ. P. 9(b) "to set forth with particularity [at least]
    the who, what, when, where, and how of" an actual false claim
    alleged to have been filed because of the defendant's actions.
    Lawton ex rel. U.S. v. Takeda Pharm. Co., 
    842 F.3d 125
    , 130 (1st
    Cir. 2016) (citations omitted). And at the summary judgment stage,
    relators must produce competent evidence of an actual false claim
    made to the government.
    When   FCA    liability         is    predicated      on    a     defendant's
    alleged off-label promotion of drugs to medical providers, that
    generally means the "specific medical provider[] who allegedly
    submitted     [the]      false    claim[],         the    rough        time    period[],
    location[],    and     amount[]       of    the    claim[],    and       the    specific
    government program[] to which the claim[] [was] made."                         
    Id. at 131
    (citations omitted). This court has made clear that where relators
    offer only "aggregate expenditure data by the government for" the
    drug at issue, "with[out] identify[ing] specific entities who
    submitted     claims      .   .   .        much    less   times,        amounts,     and
    circumstances," their claim falls "far short."                    U.S. ex rel. Ge v.
    Takeda Pharm. Co., Ltd., 
    737 F.3d 116
    , 121, 124 (1st Cir. 2013).
    - 11 -
    Relators argue that this is an impossible standard for qui tam
    relators to meet and that we should change our law.         We disagree.
    After six years of litigation, relators' only proffered
    evidence of actual false claims was aggregate data reflecting the
    amount   of    money   expended   by   Medicaid   for   pediatric   Geodon
    prescriptions (an off-label use) between January 2008 and March
    2012, according to the National Disease and Therapeutic Index's
    survey research.       See Booker II, 188 F. Supp. 3d at 129-30.       We
    have previously held comparable data insufficient on its own to
    support an FCA claim, even at the motion to dismiss stage.           See,
    e.g., Lawton, 842 F.3d at 132; Ge, 737 F.3d at 124; cf. U.S. ex
    rel. Kelly v. Novartis Pharms. Corp., 
    827 F.3d 5
    , 13-14 (1st Cir.
    2016) ("Merely alleging that a scheme was wide-ranging [and] that
    a [false] claim was presumably submitted . . . will not suffice.").
    Ultimately, "summary judgment . . . is 'the put up or
    shut up moment in litigation,'" and a relator certainly must make
    a greater showing than is required in a pleading in order "to get
    in front of a jury."     Jakobiec v. Merrill Lynch Life Ins. Co., 
    711 F.3d 217
    , 226 (1st Cir. 2013) (quoting Goodman v. Nat'l Sec.
    Agency, Inc., 
    621 F.3d 651
    , 654 (7th Cir. 2010); see also U.S. ex
    rel. Quinn v. Omnicare Inc., 
    382 F.3d 432
    , 440 (3d Cir. 2004)
    ("Without proof of an actual claim, there is no issue of material
    fact to be decided by a jury. [Relator's] theory that the claims
    - 12 -
    'must have been' submitted cannot survive a motion for summary
    judgment.").
    Relators rely on this court's Neurontin cases for the
    proposition that their aggregate data is sufficient for them to
    establish that false claims were submitted.           See In re Neurontin
    Mktg. & Sales Practices Litig. (Harden), 
    712 F.3d 60
     (1st Cir.
    2013),   cert.   denied,   
    134 S. Ct. 786
       (Mem.)   (2013)   (denying
    certiorari in all three Neurontin cases); In re Neurontin Mktg. &
    Sales Practices Litig. (Aetna), 
    712 F.3d 51
     (1st Cir. 2013); In re
    Neurontin Mktg. & Sales Practices Litig. (Kaiser), 
    712 F.3d 21
    (1st Cir. 2013). But in those cases, we held that plaintiffs could
    use aggregate data together with strong circumstantial evidence to
    overcome summary judgment on the distinct issue of whether there
    was a causal link between fraudulent marketing and demonstrated
    off-label prescriptions in the distinct context of a civil RICO
    case -- not that such proof could be used to demonstrate the
    existence of false claims in an FCA case.          See, e.g., Harden, 712
    F.3d at 68. Relators' data is woefully inadequate to support their
    FCA claim.7    We affirm entry of summary judgment for Pfizer on this
    core FCA argument.
    7    As the district court noted, relators' proffer may have
    a further shortcoming. See Booker II, 188 F. Supp. 3d at 130-31.
    Pfizer asserts, and relators do not dispute, that several state
    Medicaid programs do reimburse for the off-label uses of Geodon at
    issue here. Id. at 131. Thus, even accepting relators' aggregate
    data as proof that claims for reimbursement for off-label uses of
    - 13 -
    2.    Booker's FCA Employment Retaliation Claim
    Relators also contend that Pfizer terminated Booker's
    employment on January 6, 2010 in retaliation for two instances in
    which Booker complained to his superiors that the company was
    continuing    to       promote    Geodon   for   off-label     uses   after   the
    settlement.
    Under the FCA's anti-retaliation provision, an employer
    is prohibited from retaliating against an employee for any "lawful
    acts done . . . in furtherance of an [FCA] action . . . or other
    efforts to stop . . . violations of [the FCA]."                       
    31 U.S.C. § 3730
    (h)(1).      We have defined the type of conduct protected under
    this provision as "limited to activities that 'reasonably could
    lead' to an FCA action; in other words, investigations, inquiries,
    testimonies       or   other     activities   that   concern    the   employer's
    Geodon were filed with a Medicaid program, relators' inability to
    show that any such claim was filed in any non-reimbursing state
    might render them unable to demonstrate the falsity of any claim
    filed. Id.; see U.S. ex rel. Banigan v. Organon USA Inc., 
    883 F. Supp. 2d 277
    , 294 (D. Mass. 2012) ("[I]f a state Medicaid program
    chooses to reimburse a claim for a drug prescribed for off-label
    use, then that claim is not 'false or fraudulent,' and [FCA]
    liability cannot therefore attach [upon] reimbursement.").
    However, whether state Medicaid programs actually have the
    discretion to reimburse for off-label uses of a drug under the
    Medicaid statute "is up for debate." 
    Id.
     Because we find that
    relators' claim easily fails on other grounds, we leave this issue
    for another day.
    - 14 -
    knowing submission of false or fraudulent claims for payment to
    the government."8    Karvelas, 
    360 F.3d at 237
     (citation omitted).
    Relators rely on Booker's deposition testimony about two
    instances    in   which   Booker   objected   to   directions   from   his
    supervisor, District Manager Jon Twidwell.         Those directions, they
    say, were that Booker and other sales representatives promote sales
    based on Geodon's effect on certain conditions, such as depression
    and overt anger, though Geodon is not FDA-approved for those uses.
    Booker II, 188 F. Supp. 3d at 139.
    We affirm the grant of summary judgment for Pfizer on
    this claim, but on different grounds than those relied on by the
    district court.9    See Tutor Perini Corp. v. Banc of Am. Sec. LLC,
    8    While Karvelas interpreted this provision before it was
    amended to refer to "other efforts to stop . . . violations of
    [the FCA]," rather than only "acts done . . . in furtherance of an
    [FCA] action," see Pub. L. No. 111–203, § 1079A(c), 
    124 Stat. 1376
    ,
    2079 (2010), that addition has no effect on Karvelas's application
    to this case.    Courts have understood the amendment as having
    clarified that the provision covers not only steps in the
    litigation process, such as investigating or testifying, but also
    measures, such as internal reporting or objecting to employer
    directives, which might not be taken in direct furtherance of an
    actual lawsuit. See, e.g., Halasa v. ITT Educ. Servs., Inc., 
    690 F.3d 844
    , 847–48 (7th Cir. 2012); Miller v. Abbott Labs., 
    648 F. App'x 555
    , 560 (6th Cir. 2016) (unpublished opinion). Karvelas
    construed the pre-amendment provision as covering such activities.
    See 
    360 F.3d at 238
    .     And the amended provision maintains the
    requirement, noted in Karvelas, that even those activities must
    pertain to violations of the FCA, meaning the submission of false
    claims. See 
    id. at 237
    .
    9    The court concluded that the undisputed facts were that
    Booker had not in fact objected to off-label promotion. Booker
    II, 188 F. Supp. 3d at 139. The court reasoned that the supposed
    - 15 -
    
    842 F.3d 71
    , 84 (1st Cir. 2016) ("[W]e may affirm the summary-
    judgment holding on any grounds supported by the record, even if
    not relied on by the district judge.").       Even accepting that
    Booker's objections to the directions were concerned with off-
    label promotion, such objections, without more, are not enough
    under Karvelas.   See 
    360 F.3d at 237
    .   Evidence that an employee
    objected to or reported receipt of instructions to promote a drug's
    off-label use, absent any evidence that those objections or reports
    concerned FCA-violating activity such as the submission of false
    claims, cannot show at the summary judgment stage that the employee
    engaged in conduct protected by the FCA.
    As we stated in Karvelas, the FCA protects only conduct
    that concerns the "knowing submission of false . . . claims"
    because only such conduct "'reasonably could lead' to an FCA
    action."   
    360 F.3d at 237
    ; see also Rost, 
    507 F.3d at 727
     ("FCA
    liability does not attach to violations of federal law[s] or
    "off-label conditions" at the center of Booker's protests -- such
    as depression and overt anger -- were actually either symptoms of
    conditions for which Geodon is an on-label treatment, like
    schizophrenia, or side effects associated with such on-label uses
    of the drug. 
    Id.
     Thus, the court explained, when Booker objected
    to the directive to discuss them, he was objecting to a particular
    manner of purely on-label promotion, which, bearing no connection
    to the submission of false claims, could not reasonably lead to an
    FCA action.   Id. at 140; see also Karvelas, 
    360 F.3d at 237
    .
    Relators say there is a dispute of material fact about this issue.
    Our ruling renders it immaterial.
    - 16 -
    regulations, such as marketing of drugs in violation of the FDCA,
    that are independent of any false claim [for payment filed with
    the government].").            Thus, we have rejected, at even the motion to
    dismiss stage, an FCA retaliation claim to the extent that it was
    based on an employee's allegations that he had reported "to his
    superiors" that his employer was "fail[ing] to meet regulatory
    standards    .    .     .     required   for   reimbursement              by   Medicare   and
    Medicaid."       Karvelas, 
    360 F.3d at 237
    .                We held that the employee
    had not alleged protected conduct because he had alleged only that
    he   reported         "regulatory    failures        but    .    .    .    not    [that   he]
    investigat[ed] or report[ed] . . . false . . . claims knowingly
    submitted to the government."              
    Id.
           We reasoned that "[a]lthough
    '[c]orrecting regulatory problems may be a laudable goal,'" those
    problems were "not actionable under the FCA in the absence of
    actual fraudulent conduct," and so reporting them fell outside the
    purview of the FCA's anti-retaliation provision.                                 
    Id.
     (second
    alteration       in    original)     (citations       omitted).            Other    circuits
    agree.    See, e.g., McKenzie v. BellSouth Telecomms., Inc., 
    219 F.3d 508
    , 516 (6th Cir. 2000) ("Although internal reporting may
    constitute protected activity, the internal reports must allege
    fraud on the government."); U.S. ex rel. Yesudian v. Howard Univ.,
    
    153 F.3d 731
    , 740 (D.C. Cir. 1998) ("[It is not enough that] an
    employee[] investigat[ed] . . . his employer's non-compliance with
    federal     or        state     regulations.     .     .     .       [T]he     [employee's]
    - 17 -
    investigation    must     concern    'false     or   fraudulent'   claims."
    (citations omitted)); U.S. ex rel. Hopper v. Anton, 
    91 F.3d 1261
    ,
    1269 (9th Cir. 1996) (rejecting a retaliation claim where the
    relator "was not investigating fraud" or "trying to recover money
    for   the   government"   but   "was   merely    attempting   to   get   [her
    employer] to comply with Federal and State regulations").
    Relators do not assert that the disagreements between
    Booker and his supervisor concerned the submission of false claims.
    They thus have no trial-worthy claim of retaliation under the
    FCA.10
    C.    Discovery Rulings
    Relators challenge the district court's rulings on their
    two motions to compel the production of documents and their motion
    to defer summary judgment and compel further production under Fed.
    R. Civ. P. 56(d).       We review a district court's denial of both
    10 Because relators lack evidence that Booker engaged in
    FCA-protected conduct, we do not reach Pfizer's alternative
    argument that relators' retaliation claim fails, in any event,
    because they lack evidence that "Pfizer's proffered nonretaliatory
    reason for firing Booker -- his poor sales performance -- was a
    pretext." Booker II, 188 F. Supp. 3d at 140; see also Harrington
    v. Aggregate Indus. Ne. Region, Inc., 
    668 F.3d 25
    , 31 (1st Cir.
    2012). However, the ample evidence that Booker had a long history
    of negative performance reviews, had been placed on a series of
    remedial performance plans, and had been notified of his failure
    to comply with the requirements of his "Final" plan weeks before
    his termination -- coupled with relators' failure to argue this
    point in their opening brief -- further supports our conclusion
    that relators' retaliation claim is without merit.
    - 18 -
    types of motions for abuse of discretion.                See Wells Real Estate
    Inv. Tr. II, Inc. v. Chardon/Hato Rey P'ship, S.E., 
    615 F.3d 45
    ,
    58 (1st Cir. 2010) (motion to compel); Hicks v. Johnson, 
    755 F.3d 738
    , 743 (1st Cir. 2014) (Rule 56(d) motion).               We intervene "only
    upon a clear showing of manifest injustice, that is, where the
    [district court's decision] was plainly wrong and resulted in
    substantial prejudice."         Bogan v. City of Bos., 
    489 F.3d 417
    , 423
    (1st Cir. 2007) (citation omitted).             We find no error.
    1.   Motions to Compel
    Relators      challenge    on     appeal   the      district    court's
    handling   of   their    two    motions    to   compel    in   no   more    than   a
    perfunctory one-paragraph section of their brief.                They argue that
    the court denied both motions "wholesale," "with the sole exception
    of ordering Pfizer to produce" one particular class of documents.
    The record flatly refutes the suggestion that the district court
    did not pay appropriate attention to relators' requests.                         The
    district court was admirably attentive to the many issues in this
    case.   Relators rely on Danny B. ex rel. Elliott v. Raimondo, 
    784 F.3d 825
     (1st Cir. 2015), and cite its statement that "a district
    court may not impose discovery restrictions that preclude a suitor
    from the legitimate pursuit of evidence supporting her cause of
    action."   
    Id. at 835
    .
    Raimondo     is     inapposite.       There,   we    found     that   the
    district   court   had    abused     its   discretion       when    it    upheld   a
    - 19 -
    magistrate judge's protective order, which categorically precluded
    the plaintiffs from seeking "all policy or custom discovery."                
    Id. at 837
    .      That suit was one "to impose liability upon official-
    capacity state defendants under section 1983," and "[i]n such a
    suit, it is black letter law that the plaintiffs must prove that
    a   policy   or   custom   of   the   State    contributed   to   the   alleged
    violations of federal law in order to prevail."          
    Id. at 834
    .      Thus,
    the district court had abused its discretion because it barred the
    plaintiffs from conducting any discovery germane to an essential
    element of their claim.         Not so here.
    2.   Rule 56(d) Motion
    Relators also challenge the district court's denial of
    their Rule 56(d) motion to defer summary judgment on their AKS-
    based FCA claim until Pfizer produced a subset of the documents
    relators had sought in their second motion to compel. We put aside
    possible waiver by relators for failure to develop any legal
    argument on appeal and find no error.
    "Rule 56(d) relief is not to be granted as a matter of
    course," and a court "is entitled to refuse a Rule 56(d) motion if
    it concludes that the [movant] is unlikely to garner useful
    evidence from supplemental discovery."             Hicks, 755 F.3d at 743.
    Relators were unable to uncover evidence supporting any of the
    possible     bases   for   their   kickback    claim   after   six   years    of
    investigating.       See Booker II, 188 F. Supp. 3d at 133-34.           And a
    - 20 -
    full year after the court denied their second motion to compel but
    invited them to proffer further support for their requests at the
    summary judgment stage, the district court found that relators
    could muster only "an anecdotal report of possibly coincidental
    changes in prescription trends" to justify their Rule 56(d) motion.
    Id. at 135 n.6.   We cannot say that the court was "plainly wrong"
    to conclude that further discovery would likely be fruitless.   See
    Bogan, 
    489 F.3d at 423
    .
    II.   CONCLUSION
    The district court reached the proper outcome as to each
    of the merits issues before us on appeal, and we find no abuse of
    discretion in its management of discovery.   We affirm the judgment
    in full.   Costs are awarded to Pfizer.
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