Garcia v. Novartis Pharmaceuticals , 827 F.3d 5 ( 2016 )


Menu:
  •            United States Court of Appeals
    For the First Circuit
    No. 15-1470
    UNITED STATES OF AMERICA et al., ex. rel.,
    ALLISON KELLY, FRANK GARCIA,
    Plaintiffs, Appellants,
    v.
    NOVARTIS PHARMACEUTICALS CORPORATION; NOVARTIS CORPORATION;
    GENENTECH, INC.; and ROCHE HOLDINGS, INC.,
    Defendants, Appellees.
    APPEAL FROM THE UNITED STATES DISTRICT COURT
    FOR THE DISTRICT OF MASSACHUSETTS
    [Hon. William G. Young, U.S. District Judge]
    Before
    Kayatta, Stahl, and Barron,
    Circuit Judges.
    Timothy Cornell, with whom Cornell Dolan, P.C., was on
    brief, for appellants.
    Elliot R. Peters, with whom Steven A. Hirsch, David J.
    Silbert, Keker & Van Nest LLP, Matthew J. O'Connor, Ronald G.
    Dove, Jr., and Covington & Burling LLP, were on brief, for
    Genentech, Inc. and Roche Holdings, Inc., appellees.
    Michael A. Rogoff, with whom Debra E. Schreck, Kaye Scholer
    LLP, Tracy A. Miner, and Demeo LLP, were on brief, for Novartis
    Pharmaceuticals Corporation and Novartis Corporation, appellees.
    June 17, 2016
    STAHL, Circuit Judge.              Appellants Allison Kelly and
    Frank   Garcia      ("Relators")        brought    qui    tam    actions    against
    Appellees Genentech, Inc. and Roche Holdings, Inc. ("Genentech")
    and     Novartis      Pharmaceuticals           Corporation        and      Novartis
    Corporation ("Novartis") (collectively, "Defendants") under the
    False Claims Act ("FCA"), 
    31 U.S.C. § 3729
     et seq., and related
    state    statutes.           Relators     allege    that       Defendants     caused
    physicians and healthcare providers to submit false claims to
    the government for reimbursement for Xolair, an injected drug
    used to treat allergies.
    Because Relators failed to state their complaints with
    sufficient particularity and the district court did not abuse
    its discretion in denying Relators leave to amend, we AFFIRM the
    district court's decision to dismiss the federal claims with
    prejudice.     After dismissing the federal claims, however, the
    district court declined to exercise jurisdiction over the state-
    law   claims   and    then     dismissed    these       claims    with    prejudice.
    Because the court erred in dismissing the state-law claims with
    prejudice,     we    VACATE    this     portion    of    the     district    court's
    decision   and      REMAND    with    instructions       to     dismiss    Relators'
    state-law claims without prejudice.
    - 2 -
    I.   Facts & Background1
    Xolair is a drug approved by the FDA for treating
    moderate-to-severe persistent allergic asthma in patients twelve
    and           older              whose               symptoms          are   not   adequately    controlled   with
    inhaled corticosteroids.                                              The drug is co-promoted in the United
    States by Genentech and Novartis.
    In 2006, Frank Garcia and Allison Kelly jointly filed
    a qui tam complaint (the "2006 Garcia Complaint" or "2006 Garcia
    Action")                        alleging                       that     defendants     had      marketed   Xolair
    unlawfully.                             Garcia had been a Xolair sales representative for
    Genentech from 2003 to 2004, and Kelly had been a Xolair sales
    representative for Novartis from 2003 to 2007.                                                   The 2006 Garcia
    Complaint alleged that Defendants illegally promoted Xolair for
    off-label uses,2                                     paid kickbacks to doctors,3                encouraged sales
    1
    Because this appeal follows the granting of a motion to
    dismiss, we recite the facts as they appear in the applicable
    complaints in this action, including any documents incorporated
    by reference in those complaints. Hochendoner v. Genzyme Corp.,
    ___ F.3d ____, 
    2016 WL 2962148
    , at *1 (1st Cir. 2016).
    2
    Although the FDA only approved Xolair for treating
    moderate-to-severe persistent allergic asthma in patients twelve
    and older, it is alleged that pharmaceutical representatives for
    Novartis and Genentech visited doctors' offices and reported
    studies that claimed that Xolair was effective on patients with
    mild asthma, or that it should be used on patients who did not
    otherwise satisfy the criteria for administration of Xolair.
    The representatives supposedly also were encouraged to tell
    - 3 -
    representatives                                    to           improperly                           complete                       and             influence                         the
    completion of Statement of Medical Necessity ("SMN") forms,4 and
    targeted                     Disproportionate                                    Share               Hospitals.5                                Based               on          these
    allegations, Relators claimed that Defendants violated the FCA
    and analogous state statutes by causing false claims for Xolair
    to be presented to government healthcare programs.
    In           2010,                 another                    Genentech                         sales                representative,
    Stephen                    Fauci,                  filed                 a        complaint                        similarly                        alleging                       that
    Genentech and Novartis had promoted off-label uses of Xolair
    (the "2010 Fauci Complaint" or "2010 Fauci Action").
    After conducting a four-year investigation, the United
    States,                  in         January                   2011,               declined                     to         intervene                       in         the           2006
    Garcia Action and the 2010 Fauci Action.                                                                                         The vast majority of
    doctors that Xolair could be used for peanut and other allergies
    that did not involve asthma and could be used on children under
    the age of twelve.
    3
    Novartis and Genentech allegedly treated doctors to free
    equipment and labor, dined them at fine restaurants, and
    provided them speakers' fees and luxury trips.
    4
    An SMN is a formal prescription for medication that is
    signed by the prescribing physician.
    5
    A Disproportionate Share Hospital is a hospital that
    serves a significantly disproportionate number of low-income
    patients and receives payments from the Centers for Medicaid and
    Medicare Services to cover the costs of providing care to
    uninsured patients.
    - 4 -
    the States named as plaintiffs followed the United States' lead
    and declined as well.                                            So too did counsel for Kelly and Garcia,
    who withdrew.                                In light of this apparent unraveling, Kelly asked
    to be dismissed as a relator from the 2006 Garcia Action and
    asked that her name remain under seal.                                                     The court dismissed
    Kelly from the action and gave Garcia sixty days to file an
    amended                  complaint                       removing      all   references      to    Kelly.         Garcia
    requested several extensions of time to file this complaint as
    he sought new counsel to carry the action forward.
    Then, in June 2012, Kelly returned to the court, now
    represented by the new counsel for Garcia and Fauci, and filed
    yet           another                   qui            tam       complaint    under   seal    (the        "2012    Kelly
    Complaint" or "2012 Kelly Action").                                              In her new complaint, Kelly
    built upon the allegations contained in the pending 2006 Garcia
    and 2010 Fauci Complaints, contending that Defendants illegally
    promoted                       Xolair                    for      off-label     uses;     paid       kickbacks       to
    physicians;                           aided                and    encouraged     doctors     to      falsify      SMNs;
    targeted                     and             marketed             to   Disproportionate           Share    Hospitals;
    encouraged doctors to "upcode";6 and failed to provide the best
    price for Xolair to healthcare providers.                                                    Four months later,
    6
    "Upcoding" involves using improper billing and coverage
    codes in order to obtain higher reimbursement rates.
    - 5 -
    Garcia and Fauci moved to consolidate their actions with the new
    2012 Kelly Action and moved for leave to file an amended joint
    complaint ("Joint Complaint" or "Joint Action").        The court did
    not rule on the motion to consolidate and amend, and the federal
    government and several States once again declined to intervene.
    In 2013, the district court unsealed the 2012 Kelly
    Complaint, leaving the 2006 Garcia Action and the 2010 Fauci
    Action under seal.    Finally, in January 2014, Kelly served the
    2012 Kelly Complaint on Defendants.      That same month, the United
    States filed a motion to partially lift the seal in the 2006
    Garcia and 2010 Fauci Actions, pointing out that the 2012 Kelly
    Complaint "could be subject to dismissal under the False Claims
    Act's 'first to file' rule" because it was "based on the same
    facts underlying the complaints" in the those actions.             The
    court allowed the motion and unsealed, among other documents,
    the 2006 Garcia Complaint and the 2010 Fauci Complaint.
    Relators   then   attempted    to   re-file   their   pending
    motion to consolidate and amend.        In response, the court gave
    Defendants two weeks to respond to the proposed Joint Complaint.
    Defendants opposed the Joint Complaint on grounds of futility,
    undue delay, and prejudice.    Genentech and Novartis argued that
    the 2010 Fauci and 2012 Kelly Actions fell under the first-to-
    - 6 -
    file bar and noted that the cases had been pending for several
    years before the Joint Complaint had been filed.                                                     The next day,
    on        April               18,           2014,              the    court    entered   a   short   order    denying
    Relators' motion to consolidate and amend.
    A       few            months           later,    Defendants    filed   a     motion     to
    dismiss the 2006 Garcia Complaint and the 2012 Kelly Complaint.7
    On          March                17,            2015,           the     court      granted   Defendants'      motion,
    dismissed the federal claims with prejudice, and issued judgment
    for Defendants.                                      The court held that the 2006 Garcia and 2012
    Kelly Complaints failed to plead fraud with particularity, as
    required                    by         Federal                 Rule    of     Civil   Procedure   9(b),     and     that
    amendment would be futile.                                                 The court also dismissed Relators'
    pendent state-law claims with prejudice.                                                 Relators now appeal.
    II.     Analysis
    Relators raise three issues on appeal.                                       First, they
    contend that the district court abused its discretion when it
    denied their 2014 motion to amend and consolidate by failing to
    declare its reasoning on the record at the time of the denial.
    Second,                    Relators                      argue        that     the    district    court     erred     in
    7
    The day before Defendants filed their motion to dismiss,
    Fauci voluntarily dismissed all claims in the 2010 Fauci Action.
    - 7 -
    dismissing     their   federal    claims      with    prejudice.    Finally,
    Relators argue that the court erred in dismissing their state-
    law claims with prejudice.
    A.     Motion to Amend
    Relators claim the district court erred in its April
    18, 2014 order because it denied their first motion to amend and
    consolidate without explaining its reasoning on the record.                We
    review the denial of a motion to amend for abuse of discretion.
    United States ex rel. Poteet v. Bahler Med., Inc., 
    619 F.3d 104
    ,
    116 (1st Cir. 2010).         Here, no such abuse can be found.
    Although     the    court    could,   and   perhaps   should,   have
    foreclosed this basis for appeal through a short recitation of
    its reasoning, this omission alone is not a basis for reversal.
    As the Supreme Court held in Foman v. Davis:
    In the absence of any apparent or declared
    reason--such as undue delay, bad faith or
    dilatory motive on the part of the movant,
    repeated failure to cure deficiencies by
    amendments     previously    allowed,     undue
    prejudice to the opposing party by virtue of
    allowance of the amendment, futility of
    amendment, etc.--the leave sought should, as
    the rules require, be 'freely given.'        Of
    course,    the    grant   or  denial    of   an
    opportunity     to   amend   is   within    the
    discretion    of   the  District   Court,   but
    outright refusal to grant the leave without
    any justifying reason appearing for the
    - 8 -
    denial is not an exercise of discretion; it
    is merely abuse of that discretion . . . .
    
    371 U.S. 178
    , 182 (1962) (emphasis added).                       The court's basis
    for decision need not be declared if its reasons are apparent
    from the record.            United States ex rel. Wilson v. Bristol-Myers
    Squibb, Inc., 
    750 F.3d 111
    , 119 (1st Cir. 2014) ("We 'defer to
    the district court's hands-on judgment so long as the record
    evinces an adequate reason for the denial.'" (quoting Aponte–
    Torres v. Univ. of P.R., 
    445 F.3d 50
    , 58 (1st Cir. 2006))); ACA
    Fin. Guar. Corp. v. Advest, Inc., 
    512 F.3d 46
    , 55 (1st Cir.
    2008)    (noting      that       "the   district     court      enjoys   significant
    latitude in deciding whether to grant leave to amend" and that
    we will "defer to the district court's decision 'if any adequate
    reason    for   the    denial      is   apparent     on   the    record'"   (quoting
    LaRocca v. Borden, Inc., 
    276 F.3d 22
    , 32 n.9 (1st Cir. 2002))).
    Here,          the   court's     decision     immediately       followed
    Defendants' opposition memorandum, which set out adequate bases
    for denial: undue delay and futility.                 As Defendants pointed out
    in that memorandum, Relators "offer[ed] no valid reason" for
    "withholding for at least five years the 'additional details'
    they    s[ought]      to    include     in   their   amended     complaint."     See
    Nikitine v. Wilmington Tr. Co., 
    715 F.3d 388
    , 390–91 (1st Cir.
    - 9 -
    2013) ("[W]hen 'a considerable period of time has passed between
    the filing of the complaint and the motion to amend, courts have
    placed the burden upon the movant to show some valid reason for
    his neglect and delay.'" (quoting Hayes v. New Eng. Millwork
    Distribs., Inc., 
    602 F.2d 15
    , 19–20 (1st Cir. 1979))); Edlow v.
    RBW, LLC, 
    688 F.3d 26
    , 40 (1st Cir. 2012) (affirming denial when
    "the factual predicates on which the proposed amended complaint
    is based are the same as those in the original complaint and
    were known to [plaintiff] before he filed suit").
    Relators' proposed amendment also was futile because
    any attempt to consolidate the 2010 Fauci Action and 2012 Kelly
    Action with the still-pending 2006 Garcia Action would be little
    more than an attempt to circumvent the FCA's first-to-file bar.
    See 
    31 U.S.C. § 3730
    (b)(5) ("When a person brings an [FCA qui
    tam action on the government's behalf], no person other than the
    Government may intervene or bring a related action based on the
    facts underlying the pending action.").8                                                 The district court
    would                later                 (erroneously)              reject     Defendants'      first-to-file
    argument                    with              respect          to   the   2012   Kelly   Action    due   to   her
    8
    Relators sought more than the routine consolidation of
    independent actions for pre-trial proceedings and administrative
    purposes; Relators sought to merge three distinct actions into
    one single proceeding operating under one single complaint.
    - 10 -
    original involvement in the 2006 Garcia Action.             However, at the
    time of the initial motion to consolidate and amend, Relators
    sought   to    incorporate   the   2010   Fauci   Action   as    well.     This
    merger of cases would have been an obvious violation of the
    first-to-file rule.          Thus, the reasons for the court's 2014
    decision were readily apparent from the record, and the court's
    denial of Relators' motion was not an abuse of discretion.
    B.   Relators' Federal-Law Claims
    Relators next contend the court erred in its March 17,
    2015 order when it dismissed the FCA claims in the 2006 Garcia
    and 2012 Kelly Actions and, again, denied leave to amend.                    We
    review the granting of a motion to dismiss de novo, Buntin v.
    City of Bos., 
    813 F.3d 401
    , 404 (1st Cir. 2015), "accepting as
    true all well-pleaded facts, analyzing those facts in the light
    most   hospitable    to   the   plaintiff's   theory,      and   drawing   all
    reasonable inferences for the plaintiff," United States ex rel.
    Hutcheson v. Blackstone Med. Inc., 
    647 F.3d 377
    , 383 (1st Cir.
    2011).   In its decision, the district court rejected Defendants'
    argument that the 2012 Kelly Complaint should be dismissed under
    the first-to-file bar.        Instead, the court dismissed the federal
    claims in both the 2006 Garcia and 2012 Kelly Actions based on
    - 11 -
    their      failure     to    plead   the     alleged     fraud    with     sufficient
    particularity to satisfy Federal Rule of Civil Procedure 9(b).
    i.      First to File
    We      first    examine      Defendants'       contention     that    the
    district court should have dismissed the 2012 Kelly Action based
    on   the    first-to-file        rule.         This   rule    bars   a    later-filed
    "related action," 
    31 U.S.C. § 3730
    (b)(5), that alleges "all the
    essential facts" or "the same elements of a fraud described" in
    an   earlier-filed           complaint     while      that   complaint     is      still
    pending, Wilson, 750 F.3d at 117.
    In this case, all of the parties agreed, and the court
    found, that the two suits involved "the same basic facts and
    issues" and were "virtually identical to each other."                           United
    States ex rel. Garcia v. Novartis AG, 
    91 F. Supp. 3d 87
    , 99 (D.
    Mass. 2015).          Yet, the court held that the first-to-file rule
    "ought not bar the exercise of jurisdiction over the [2012 Kelly
    Action] in this particular case" because "Kelly and Garcia co-
    filed the Garcia Complaint."             
    Id.
    In so holding, the district court erred.                     Neither the
    text nor the purpose of the statute permit such an exception.
    The stark "no person" language of the rule is plainly stated and
    "exception-free."            Wilson, 750 F.3d at 117; see also United
    - 12 -
    States ex rel. Duxbury v. Ortho Biotech Prods., L.P. (Duxbury),
    
    579 F.3d 13
    , 16, 32-33 (1st Cir. 2009).                           The resulting bar
    furthers the FCA's goal of avoiding piecemeal and duplicative
    ligation that does not advance the government's investigation of
    alleged fraud.          Once the government has "sufficient notice to
    launch [an] investigation[,] . . . [a] later-filed complaint
    that mirrors the essential facts as the pending earlier-filed
    complaint       does    nothing    to     help    reduce     fraud       of    which     the
    government is already aware."               United States ex rel. Heineman-
    Guta v. Guidant Corp., 
    718 F.3d 28
    , 35-36 (1st Cir. 2013).
    It     is    true     that    Kelly    was      not    the        prototypical
    "opportunistic" or "parasitic" plaintiff, Novartis, 91 F. Supp.
    3d   at   99;    however,       Kelly    cannot    escape       the     fact     that    she
    voluntarily requested dismissal without prejudice from the 2006
    Garcia    Action.        "'Without       prejudice'      does     not    mean    'without
    consequence.'"          Powell v. Starwalt, 
    866 F.2d 964
    , 966 (7th Cir.
    1989).    Nothing about her prior involvement in the 2006 Garcia
    Action could serve to dissolve the independent statutory bar to
    her bringing a new, and essentially identical, action in 2012.
    See United States ex rel. Shea v. Cellco P'ship, 
    748 F.3d 338
    ,
    342-43    (D.C.    Cir.    2014),       cert.    granted,    judgment          vacated   on
    other grounds, 
    135 S. Ct. 2376
     (2015) (holding that "[n]o rule
    - 13 -
    of   grammar,      logic,    or   the   law      compels"      a    reading      "that    the
    first-to-file       bar     applies     only     to     litigants        other     than   the
    relator who filed the original action"); United States ex rel.
    Moore v. Pennrose Props., LLC, No. 3:11-cv-121, 
    2015 WL 1358034
    ,
    at   *15   (S.D.    Ohio     Mar.    24,    2015)       (finding     that    a     relator's
    status as an earlier filer did not prevent the first-to-file
    rule from barring his subsequent complaint); United States ex
    rel. Syzmoniak v. ACE Sec. Corp., C/A No. 0:13-cv-00464-JFA,
    
    2014 WL 1910876
    , at *1-2, *4-6 (D.S.C. May 12, 2014) (dismissing
    second qui tam suit on first-to-file grounds even though same
    relator had filed earlier suit and second suit named additional
    defendants);       United    States        ex    rel.    Smith      v.   Yale-New     Haven
    Hosp.,     Inc.,     
    411 F. Supp. 2d 64
    ,       75-76    (D.    Conn.     2005)
    (dismissing second qui tam complaint filed by the same relator
    on first-to-file grounds because the bar applies "equally to the
    original relator as any other person").
    Although Relators argue that Kelly "brought her claims
    with her" when she left the 2006 Garcia Action, this is little
    more than a thin fiction.                  When Kelly was dismissed from the
    2006 Garcia Action, the court only ordered that Garcia file an
    amended    complaint        and     "remov[e]         all    references       to    Relator
    Allison Kelly"; an order which, in any event, was not followed.
    - 14 -
    Kelly may have left the 2006 Garcia Action, but the essential
    allegations remained behind.
    For   these   reasons,    the     2012   Kelly    Complaint   should
    have been dismissed under the first-to-file bar.                  This does not,
    however, end our inquiry.         Complaints dismissed under the first-
    to-file bar are usually dismissed without prejudice.                  See United
    States ex rel. Gadbois v. PharMerica Corp., 
    809 F.3d 1
    , 3 (1st
    Cir.    2015)   ("[T]he     dismissal    of     a   section    3730(b)(5)    claim
    ordinarily should be without prejudice, because the claim could
    be refiled once the first-filed action is no longer pending.").
    Yet, this case presents a procedural wrinkle.                 If the
    court properly dismissed the 2006 Garcia Complaint based on its
    failure to allege fraud with sufficient particularity, then the
    presently "pending" case would drop out and the first-to-file
    bar on the 2012 Kelly Complaint might be lifted.                   See 
    id. at 6
    .
    In such circumstances, Kelly could conceivably supplement or re-
    file her complaint.         See 
    id. at 7-8
    .
    In this case, however, remanding would be a wasteful
    formality.      Even if the district court were to find on remand
    that it now had jurisdiction, that court has already held that
    the    2012   Kelly   Complaint   is     insufficiently        particularized   to
    offset a Rule 9(b) challenge.            Because we would send the action
    - 15 -
    back to a fate certain and the merits of the district court's
    particularity decision are undoubtedly correct, we will spare
    the litigants a costly and unnecessary round trip and address
    the          district                     court's               particularity     decisions    with   respect   to
    both complaints now.9                                          Cf. Bullard v. Hyde Park Sav. Bank (In re
    Bullard), 
    752 F.3d 483
    , 485 n.1 (1st Cir. 2014), aff'd sub nom.
    Bullard v. Blue Hills Bank, 
    135 S. Ct. 1686
     (2015).
    ii.           Particularity
    The district court held that neither the 2006 Garcia
    Complaint                        nor             the           2012    Kelly     Complaint    pled    fraud   with
    sufficient particularity to survive the demands of Federal Rule
    of Civil Procedure 9(b).                                              Rule 9(b) requires that "[i]n alleging
    fraud or mistake, a party must state with particularity the
    9
    We assume, but need not decide, that the first-to-file bar
    remains jurisdictional.    This position is not without doubt.
    See Gadbois, 809 F.3d at 6 n.2 ("[W]e have no need to consider
    the relator's back-up argument that the first-to-file bar is not
    jurisdictional in light of [Kellogg Brown & Root Servs., Inc. v.
    United States ex rel. Carter, 
    135 S. Ct. 1970
     (2015)]."). Even
    if the first-to-file bar were non-jurisdictional, however, we
    would still be faced with a question of particularity and
    futility.   See United States ex rel. Shea v. Verizon Commc'ns,
    Inc., No. 09–1050(GK), 
    2015 WL 7769624
    , at *11 (D.D.C. Oct. 6,
    2015) ("The Court has already concluded that Plaintiff's action
    must be dismissed without prejudice under § 3730(b)(5). . . .
    Accordingly, the only question the Court must consider is
    whether dismissal with prejudice under Rules 8 and 9(b) is
    warranted.").
    - 16 -
    circumstances constituting fraud or mistake."                  The particularity
    requirement    means     that   a   complaint      must    specify   "the       time,
    place, and content of an alleged false representation."                         Doyle
    v. Hasbro, Inc., 
    103 F.3d 186
    , 194 (1st Cir. 1996) (quoting
    McGinty v. Beranger Volkswagen, Inc., 
    633 F.2d 226
    , 228 (1st
    Cir. 1980)).     Conclusory allegations and references to "plans
    and schemes" are not sufficient.               
    Id.
     (quoting Hayduk v. Lanna,
    
    775 F.2d 441
    , 444 (1st Cir. 1985)).
    Where,      as   here,   it    is    alleged    that    the    defendant
    caused a third party to submit a claim to the government, then
    the First Circuit applies a somewhat "more flexible" standard,
    allowing a relator to satisfy Rule 9(b) by providing "factual or
    statistical evidence to strengthen the inference of fraud beyond
    possibility    without      necessarily    providing      details    as    to    each
    false claim" submitted.          Duxbury, 
    579 F.3d at 29-30
     (citations
    and internal quotation marks omitted).                    However, "it is the
    fraud itself which must be pled with particularity, not just who
    benefits from the fraud and what pot of federal money may be the
    object of the fraud."           United States ex rel. Gagne v. City of
    Worcester, 
    565 F.3d 40
    , 47 (1st Cir. 2009).
    In other words, it is not enough simply to "rais[e]
    facts   that   suggest      fraud   was   possible    .    .   .   [because,      for
    - 17 -
    example, it] may well be that [those] doctors who prescribed
    [the   drug]     for    off-label      uses    as     a    result    of     [the]   illegal
    marketing of the drug withstood the temptation and did not seek
    federal reimbursement, and neither did their patients."                             United
    States ex rel. Rost v. Pfizer, Inc., 
    507 F.3d 720
    , 733 (1st Cir.
    2007), overruled in part by Allison Engine Co. v. United States
    ex rel. Sanders, 
    553 U.S. 662
     (2008).                      Because "[i]t may be that
    physicians prescribed [the drug] for off-label uses only where
    the    patients    paid    for    it    themselves          or     when    the   patients'
    private insurers paid for it," 
    id.,
     the evidence necessary to
    "strengthen      the    inference      of     fraud       beyond    possibility,"       
    id.,
    generally requires the relator to plead, inter alia, "specific
    medical    providers      who    allegedly       submitted         false    claims,"     the
    "rough time periods, locations, and amounts of the claims," and
    "the   specific        government      programs       to    which     the    claims     were
    made."     United States ex rel. Ge v. Takeda Pharm. Co., Ltd., 
    737 F.3d 116
    , 121, 124 (1st Cir. 2013).                         Merely alleging that a
    scheme was wide-ranging--and, therefore, that a fraudulent claim
    was presumably submitted--will not suffice.
    Nor is evidence of illegal conduct alone sufficient to
    state an FCA claim.          See Rost, 
    507 F.3d at 732
    .                     FCA liability
    attaches    to    a     "false    or    fraudulent           claim    for     payment    or
    - 18 -
    approval" or to a "false record or statement material to a false
    or   fraudulent     claim."     
    31 U.S.C. § 3729
    (a)(1)(A)-(B).            "FCA
    liability    does    not   attach    to   violations     of    federal    law    or
    regulations, such as marketing of drugs in violation of the
    [Food, Drug & Cosmetic Act, 
    21 U.S.C. § 321
     et seq.], that are
    independent of any false claim."           Rost, 
    507 F.3d at 727
    .
    Rather, the complaint must identify the alleged fraud
    with   a   significant     degree    of   specificity.        In   Duxbury,     for
    example, the relator alleged that, through a company's illegal
    kickbacks,    false    claims   to    Medicare    were    filed     by   medical
    providers for reimbursement of drug purchases.                
    579 F.3d at 29
    .
    Duxbury set[] forth allegations of kickbacks
    provided by [the company] that resulted in
    the submission of false claims by eight
    [named] healthcare providers in the Western
    United States . . . . As to each, Duxbury
    provide[d] information as to the dates and
    amounts of the false claims filed by these
    providers with the Medicare program.
    
    Id. at 30
    .        Although the Duxbury court said the case was "a
    close call," it found that the relator's claims satisfied Rule
    9(b) because he alleged the "who, what, where, and when of the
    allegedly    false    or   fraudulent     representation."         
    Id.
       (quoting
    Rodi v. S. New Eng. Sch. of Law, 
    389 F.3d 5
    , 15 (1st Cir.
    2004)).     "In particular, Duxbury ha[d] identified, as to each of
    - 19 -
    the eight medical providers (the who), the illegal kickbacks
    (the what), the rough time periods and locations (the where and
    when), and the filing of the false claims themselves."   
    Id.
    Similarly, in United States ex rel. Westmoreland v.
    Amgen, Inc., the complaint "contain[ed] allegations regarding
    particular medical providers who submitted legally and factually
    false claims at the Defendants' encouragement."   
    738 F. Supp. 2d 267
    , 276 (D. Mass. 2010).   In particular:
    Relator pleads that the Defendants advised
    doctors at Balboa Nephrology . . . to
    capture all overfill profit, which led
    Balboa to issue a standing order for doctors
    to write Aranesp orders for an amount that
    was 10% more than the standard dosage that
    otherwise would have been administered for
    every patient, and a standing order that
    Medical Assistants were to administer as
    much Aranesp in the vial as possible.
    Relator also alleges that California Kidney
    Group . . . billed Aranesp 15% over the
    labeled dosage even though it is not
    actually possible to withdraw 15% overfill
    from   a  single  dose  vial,   and  sought
    reimbursement for dosages of Aranesp above
    the amount intended to be administered to
    the patient.
    
    Id. at 276-77
     (citations omitted).      In short, the defendants
    "knew that their actions 'would, if successful, result in the
    submission by [providers] of compliance certifications required
    by Medicare that [the defendants] knew would be false.'"   
    Id.
     at
    - 20 -
    277-78 (alterations in original) (quoting United States ex rel.
    Schmidt v. Zimmer, Inc., 
    386 F.3d 235
    , 244 (3d Cir. 2004)).
    When one compares the allegations made in the 2006
    Garcia Complaint and the 2012 Kelly Complaint to the allegations
    made in Duxbury and Westmoreland, it becomes clear that the
    pleadings here do not meet the requisite level of specificity.
    In fact, the allegations in Duxbury, which outstrip those found
    here, were only "barely adequate."         See Ge, 737 F.3d at 124.
    The closest Relators get to positing the existence of fraud is
    to allege that certain doctors, at various points, (1) were
    enrolled   in    federal   reimbursement    programs,      (2)    received
    services   and   incentives   from   Defendants,   and   (3)     prescribed
    Xolair.    Relators failed, however, to tie these independently
    unexceptional allegations together into particularized charges
    about specific fraudulent claims for payment.            With respect to
    the 2012 Kelly Complaint, for example, the district court found
    that Kelly pleaded "no evidence of any false statement, SMN
    form, or claim that effectively was submitted," "identif[ied] no
    claims for reimbursement to Medicare, Medicaid, or any other
    federal health care program," and "fail[ed] to provide even a
    single example of fraudulent conduct resulting in reimbursement
    of Xolair by a federal health care program[.]"              Novartis, 91
    - 21 -
    F. Supp. 3d at 109.        The district court found that Kelly, like
    Garcia, had not "provid[ed] reliable indicia that the alleged
    underlying schemes resulted in submission of false claims," nor
    had   she   "br[ought]    forward      evidence       that   the    physicians    who
    prescribed Xolair sought federal reimbursement."                    Id.
    Of course, it may not be "irrational to infer that,
    given     [the    allegations],        some     false      claims    for    [Xolair]
    reimbursement were submitted to the government."                    Rost, 
    507 F.3d at 732
    .     But this is not enough to satisfy Rule 9(b).                   Relators'
    allegations "g[i]ve rise to only speculation as to whether the
    alleged     scheme   caused     the    filing    of     false    claims    with   the
    government."         Duxbury,    
    579 F.3d at 31
    .       Because    Relators'
    evidence    and    arguments    proceed       more    by    insinuation    than   any
    "factual    or    statistical    evidence       [that      would]   strengthen    the
    inference of fraud beyond possibility," Rost, 
    507 F.3d at 733
    ,
    the district court properly dismissed Relators' federal claims.
    The court's further decision to dismiss the federal
    claims with prejudice likewise cannot be faulted.                     Relators had
    repeatedly failed to cure the deficiencies in their complaints,
    and the proposed Joint Complaint promised more of the same.
    Although the Joint Complaint added extra grist for speculation,
    it offered nothing new of substance to cure the inferential gaps
    - 22 -
    found in Relators' prior complaints.                    We need hardly rely upon
    the abuse-of-discretion standard to affirm the district court's
    decision to dismiss the federal claims with prejudice.
    C.     Relators' State-Law Claims
    Finally, Relators claim that the district court erred
    when it dismissed their pendant state-law claims with prejudice.
    "As   a   general       principle,      the    unfavorable          disposition        of   a
    plaintiff's         federal   claims     at    the    early     stages      of    a     suit
    . . . will          trigger   the    dismissal       without    prejudice         of    any
    supplemental         state-law      claims."      Rodriguez         v.    Doral     Mortg.
    Corp.,    
    57 F.3d 1168
    ,    1177   (1st     Cir.      1995).        However,      "this
    praxis is not compelled by a lack of judicial power. . . . In an
    appropriate situation, a federal court may retain jurisdiction
    over state-law claims notwithstanding the early demise of all
    foundational federal claims."            
    Id.
    Relators alleged violations of a number of state false
    claims acts.          In its decision, the district court dismissed the
    federal-law          claims   but     declined       "to    exercise       supplemental
    jurisdiction over the state law claims."                     Novartis, 91 F. Supp.
    3d at 112.          The court recognized that, when federal claims are
    dismissed at such an early stage, "any supplemental state-law
    claims" should be dismissed without prejudice.                             Id. (quoting
    - 23 -
    Rossi v. Gemma, 
    489 F.3d 26
    , 39 (1st Cir. 2007)).                                  Consequently,
    the court stated that "Relators' claims for relief under the
    individual         states'    qui       tam     statutes          are     dismissed,      albeit
    without prejudice."           
    Id.
     (emphasis added).
    In     its     conclusion,         however,              the     district     court
    inexplicably reversed course and dismissed Relators' state-law
    claims    with      prejudice.           
    Id.
          Relators             filed   a    Request    for
    Clarification,         and        the    Court         responded,            without      further
    explanation,        that     it    had    intended          to    dismiss       the     state-law
    claims with prejudice as well.
    Defendants contend that the court dismissed the state-
    law claims for the same reason it dismissed the federal-law
    claims: failure to plead fraud with particularity.                                  The court's
    conclusion to its opinion reflects this reading: "[T]he claims
    alleged in Garcia's and Kelly's complaints, pursuant to . . .
    the individual states' equivalent qui tam provisions, lack the
    particularity required under Rule 9(b) for pleading fraud."                                   
    Id.
    But this conclusion simply cannot be reconciled with
    the     court's       earlier       decision           in        its     opinion        declining
    jurisdiction over the state-law claims.                           A court cannot dismiss
    a     claim   on     the     merits       if     it     has       declined         to    exercise
    jurisdiction over the claim at all.                     That is not to say that the
    - 24 -
    court would have lacked the power to dismiss the claims with
    prejudice if it had retained jurisdiction.                    See Rodriguez, 
    57 F.3d at 1177
    .       But here the court declined jurisdiction and then
    purported to dismiss the claims with prejudice.                      That does not
    wash.
    Because      the    district     court   expressly       relinquished
    jurisdiction       over    Relators'      state-law      claims,     we    think    it
    appropriate to vacate the district court's decision to dismiss
    the state-law claims with prejudice and remand so that the court
    may dismiss the state-law claims without prejudice.
    III.    Conclusion
    For    the    foregoing      reasons,    we   AFFIRM    the    district
    court's   dismissal         of     Relators'      federal-law        claims        with
    prejudice,    and    we    VACATE       the   district     court's    decision      to
    dismiss Relators' state-law claims with prejudice.                        On REMAND,
    the district court is instructed to dismiss Relators' state-law
    claims without prejudice.
    - 25 -
    

Document Info

Docket Number: 15-1470P

Citation Numbers: 827 F.3d 5

Filed Date: 6/17/2016

Precedential Status: Precedential

Modified Date: 1/12/2023

Authorities (21)

United States Ex Rel. Gagne v. City of Worcester , 565 F.3d 40 ( 2009 )

United States Ex Rel. Poteet v. Bahler Medical, Inc. , 619 F.3d 104 ( 2010 )

Boyle v. Hasbro, Inc. , 103 F.3d 186 ( 1996 )

ACA Financial Guaranty Corp. v. Advest, Inc. , 512 F.3d 46 ( 2008 )

LaRocca v. Borden, Inc. , 276 F.3d 22 ( 2002 )

United States Ex Rel. Hutcheson v. Blackstone Medical, Inc. , 647 F.3d 377 ( 2011 )

united-states-of-america-ex-rel-richard-g-schmidt-md-v-zimmer-inc , 386 F.3d 235 ( 2004 )

Rodriguez-Bruno v. Doral Mortgage , 57 F.3d 1168 ( 1995 )

Kathleen McGinty v. Beranger Volkswagen, Inc. , 633 F.2d 226 ( 1980 )

Joseph J. Hayes v. New England Millwork Distributors, Inc. , 602 F.2d 15 ( 1979 )

United States Ex Rel. Duxbury v. Ortho Biotech Products, L.... , 579 F.3d 13 ( 2009 )

United States Ex Rel. Rost v. Pfizer, Inc. , 507 F.3d 720 ( 2007 )

Robert G. Hayduk v. Vincent T. Lanna , 775 F.2d 441 ( 1985 )

Rossi v. Gemma , 489 F.3d 26 ( 2007 )

James Powell, Jr. v. Donald Starwalt , 866 F.2d 964 ( 1989 )

Foman v. Davis , 83 S. Ct. 227 ( 1962 )

Allison Engine Co. v. United States Ex Rel. Sanders , 128 S. Ct. 2123 ( 2008 )

Kellogg Brown & Root Services, Inc. v. United States Ex Rel.... , 135 S. Ct. 1970 ( 2015 )

United States Ex Rel. Smith v. Yale-New Haven Hospital, Inc. , 411 F. Supp. 2d 64 ( 2005 )

United States Ex Rel. Westmoreland v. Amgen, Inc. , 738 F. Supp. 2d 267 ( 2010 )

View All Authorities »