Court Opinion

ID: 3214415
Source: CourtListenerOpinion
Date Created: 2016-06-17 20:00:43.142866+00
Date Added: 2024-06-11T09:19:21.679089
License: Public Domain

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 -