          United States Court of Appeals
                      For the First Circuit

No. 16-1304

              ANDREW HAGERTY, ex rel. UNITED STATES;

                       Relator, Appellant,

   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 IOWA;
        STATE OF LOUISIANA; STATE OF MARYLAND; COMMONWEALTH OF
  MASSACHUSETTS; STATE OF MICHIGAN; STATE OF MINNESOTA; STATE OF
     MONTANA; STATE OF NEVADA; 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; COMMONWEALTH OF VIRGINIA; STATE OF WASHINGTON; STATE OF
                    WISCONSIN; DISTRICT OF COLUMBIA

                           Plaintiffs,

                                v.

                        CYBERONICS, INC.,

                       Defendant, Appellee.


          APPEAL FROM THE UNITED STATES DISTRICT COURT
                FOR THE DISTRICT OF MASSACHUSETTS

        [Hon. F. Dennis Saylor, IV, U.S. District Judge]


                              Before

                    Barron, Selya, and Stahl,
                         Circuit Judges.


     Joseph S. Hall, with whom Silvija A. Strikis, Katherine C.
Cooper, Rachel Proctor May, Kellogg, Huber, Hanson, Todd, Evans &
Figel, P.L.L.C., Suzanne E. Durrell, Durrell Law Office, Robert M.
Thomas, Jr., and Thomas & Associates were on brief, for appellant.
     William M. Katz, Jr., with whom Melissa Michelle Davis, J.
Patrict Bredehoft, Richard B. Phillips, Thompson & Knight LLP,
Timothy H. Madden, and Donnelly, Conroy & Gelhaar LLP were on
brief, for appellee.


                        December 16, 2016
             STAHL, Circuit Judge.      Relator-Appellant Andrew Hagerty

("Hagerty") brought a qui tam action against Appellee Cyberonics,

Inc. ("Cyberonics") alleging, among other things, that Cyberonics

violated the False Claims Act ("FCA"), 31 U.S.C. § 3729 et seq.,

and related state statutes.        Specifically, Hagerty alleged that

Cyberonics     promoted     medically    unnecessary   replacements     of

batteries in nerve stimulator devices used to treat epilepsy

patients, which in turn resulted in patients and medical providers

filing false claims for reimbursement from government health care

programs.

             The district court dismissed all but two of Hagerty's

claims under Federal Rule of Civil Procedure 12(b)(6), including

the   FCA    allegations,    holding    that   Hagerty's   First   Amended

Complaint was not pled with the particularity required by Federal

Rule of Civil Procedure 9(b).1           Following this dismissal, the

district court also denied Hagerty's request for leave to file a

Second Amended Complaint on the basis of undue delay.         Hagerty now

challenges the district court's ruling on both fronts, maintaining

that his First Amended Complaint satisfies Rule 9(b) and asserting


      1Hagerty's surviving claims against Cyberonics were his
allegations regarding retaliatory discharge under 31 U.S.C. §
3730(h) (Count 31) and wrongful termination and retaliation in
violation of public policy under Mass. Gen. Laws ch. 12, § 5J
(Count 33). These claims were voluntarily dismissed without
prejudice and are not on appeal. Hagerty also does not separately
address the dismissal of his other state law claims in his briefing
to this court. We similarly decline to do so in our opinion.


                                  - 3 -
that the district court abused its discretion when denying his

motion for leave to file a Second Amended Complaint. After careful

consideration, we affirm.

                         I. Facts & Background

            We recite the relevant facts as they appear in Hagerty's

First Amended Complaint. See Hochendoner v. Genzyme Corp., 823

F.3d 724, 730 (1st Cir. 2016).      The Vagus Nerve Stimulator (VNS)

is a medical device that is implanted in patients with refractory

epilepsy, a severe form of the disease in which a patient's

seizures seriously interfere with their quality of life and do not

respond to other medications or treatment.            The VNS works by

delivering short electrical pulses to the vagus nerve through a

wire.   Each VNS system contains a battery, and the entire VNS

system must be surgically replaced when the battery nears the end

of its life.

            Patients with refractory epilepsy often qualify for

coverage under government healthcare programs like Medicare and

Medicaid.      Some treatments for refractory epilepsy, including

placement of the VNS, are reimbursed by those programs.            These

programs impose certain requirements on healthcare providers, such

as signing a Provider Agreement with the Centers for Medicare and

Medicaid    Services   ("CMS").    In     these   agreements,   providers

certify, among other things, that their claims for reimbursement




                                  - 4 -
relate to a reasonable and medically necessary treatment.                      42

U.S.C. § 1395y(a)(1)(A).

            On February 4, 2013, Hagerty filed a qui tam complaint

under seal against Cyberonics, alleging that it engaged in a

fraudulent scheme to encourage doctors and patients to prematurely

and unnecessarily replace batteries in VNS systems.                     Hagerty,

having gained knowledge of the scheme firsthand as a former sales

representative of Cyberonics, further alleged that this scheme

caused    significant    monetary      damages   to   government      healthcare

programs by inducing patients and medical providers to file false

claims for reimbursement in violation of 31 U.S.C. § 3729(a).                  On

October 29, 2013, the government filed a notice declining to

intervene in the case, and on December 5, 2013 the complaint was

unsealed and served on Cyberonics.               Cyberonics then moved to

dismiss the complaint on April 28, 2014 on several grounds,

including under Rule 12(b)(6) for failure to state a claim and

Rule     9(b)   for   failure     to   allege    instances    of     fraud   with

particularity.

            Hagerty     amended    his   pleadings    and    filed    his    First

Amended Complaint on May 19, 2014.              The First Amended Complaint

alleged that in 2005, the FDA approved the VNS as a treatment for

depression, and, anticipating that much of its future growth would

come from this market, Cyberonics hired 300 new salespersons.

Cyberonics then allegedly began lobbying CMS to approve Medicare


                                       - 5 -
reimbursement for VNS therapy in depressive patients, which CMS

ultimately declined to grant.         Facing a dire financial situation2,

Cyberonics reportedly decided to refocus its sales efforts on

epilepsy patients, with a particular interest in re-sales to

already existing VNS patients.

            The First Amended Complaint emphasized that this new

sales plan was driven by a "carrot and stick" approach, where sales

representatives      were   rewarded    for   meeting   "aggressive      sales

quotas," were placed in a Performance Improvement Program if they

did not achieve 75% of their revenue goals in a given quarter, and

were terminated the following quarter if their performance did not

improve.    Hagerty alleged that, under such conditions, Cyberonics'

sales representatives resorted to fraudulent sales tactics, such

as refusing to provide doctors and patients with accurate VNS

battery life calculations and encouraging doctors and patients to

replace these batteries prematurely.3

            The     First   Amended    Complaint   further     alleged    that

approximately 50% of Cyberonics' revenue came from Medicare and

Medicaid,    with    additional   revenues    coming    from   TRICARE,    the


     2 At the time CMS denied its request, Cyberonics was allegedly
$132.5 million in debt.
     3 Cyberonics employees purportedly represented that these
batteries should be replaced after four or five years despite their
average lifespan being between eight and nine years. As a result
of this new sales tactic, Hagerty alleges that Cyberonics erased
its debt by 2010 and avoided bankruptcy.


                                      - 6 -
Department of Defense, the Department of Veterans Affairs, and the

Federal Employee Health Benefits Program.              Hagerty went on to list

sixteen hospitals which he claimed had performed and billed for

VNS therapy implants in epileptic patients, and specifically named

the Southbury Training School, Monson Development Center, and

Wrentham Development Center as "long-term care facilities . . . in

which vulnerable patients were subjected to unnecessary surgeries

to implant replacement devices."                The First Amended Complaint

further identified a Dr. Pena, who had three patients undergo

battery replacement procedures between September 30, 2010 and

November    18,    2010.     It   also   identified     a    Dr.   Thompson,   who

allegedly told Hagerty that a Cyberonics sales representative

falsely told physicians to replace VNS batteries prematurely.

Moreover,    the    First    Amended     Complaint     alleged     that    Hagerty

reviewed an internal patient list and saw that several of Dr.

Thompson's patients had received VNS device replacements in 2010.

            By    way   of   conclusion,       the   First   Amended      Complaint

projected that at least 10,000 medically unnecessary VNS device

replacements had occurred at these hospitals and centers since

2007.   Coupled with an estimated cost of $20,000 per procedure and

an   assumption      that    government        healthcare     programs     covered

approximately 50-60% of these procedures, Hagerty reasoned that

government healthcare programs lost at least $100 million as a

result of Cyberonics' scheme.


                                       - 7 -
          Cyberonics again moved to dismiss the case.            On March

31, 2015, the district court granted the motion, finding that

Hagerty   had   not   pled   his    allegations     with   the   requisite

particularity required by Rule 9(b).          On August 14, 2015, Hagerty

moved for leave to file a Second Amended Complaint.          Three months

later, the district court denied Hagerty's motion on the basis of

undue delay.4   This appeal followed.

                                II. Analysis

          Hagerty     insists    that   his    First   Amended   Complaint

satisfied Rule 9(b)'s particularity requirement and, regardless of

the district court's view on that matter, that he should have been

given leave to file a Second Amended Complaint.            We review the

granting of a motion to dismiss de novo, United States ex rel.

Gagne v. City of Worcester, 565 F.3d 40, 45 (1st Cir. 2009), and

the denial of a motion to amend for abuse of discretion, United

States ex rel. Kelly v. Novartis Pharms. Corp., 827 F.3d 5, 10

(1st Cir. 2016) (citing United States ex rel. Poteet v. Bahler

Med., Inc., 619 F.3d 104, 116 (1st Cir. 2010)).




     4 Cyberonics alternatively argues that the district court also
denied Hagerty's motion because any amendment would have been
futile. Since, as we will explain, the district court's denial
was justified under an undue delay analysis, we decline to consider
the futility of Hagerty's proposed amendments.


                                   - 8 -
     A. The FCA and Rule 9(b)

             The FCA penalizes those who present, or cause to be

presented, "false or fraudulent claim[s] for payment or approval"

to the federal government.             31 U.S.C. § 3729(a)(1).         Thus, fraud

under the FCA has two components: the defendant must submit or

cause the submission of a claim for payment to the government, and

the claim for payment must itself be false or fraudulent.                    United

States ex rel. Ge v. Takeda Pharm. Co., 737 F.3d 116, 124 (1st

Cir. 2013) ("Because FCA liability attaches only to false claims,

merely alleging facts related to a defendant's alleged misconduct

is not enough.         Rather, a complaint based on [the FCA] must

sufficiently    establish         that    false    claims    were   submitted   for

government    payment       as    a    result     of   the   defendant's   alleged

misconduct.") (internal citations omitted).

             Federal       Rule   of     Civil    Procedure    9(b),    meanwhile,

requires     that      a    complaint       state      these    components      with

"particularity," meaning relators like Hagerty must allege the

"who, what, when, where, and how of the alleged fraud."                      Id. at

123 (internal citation and quotation marks omitted).                    Still, we

have repeatedly emphasized that there is no "checklist of mandatory

requirements" that each allegation in a complaint must meet to

satisfy Rule 9(b), United States ex rel. Karvelas v. Melrose-

Wakefield Hosp., 360 F.3d 220, 233 (1st Cir. 2004), abrogated on

other grounds by Gagne, 565 F.3d at 46 n.7, and that a "somewhat


                                         - 9 -
'more flexible' standard" applies in qui tam actions where the

defendant is alleged to have induced third parties to file false

claims, Kelly, 827 F.3d at 13 (1st Cir. 2016) (quoting United

States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13,

29-30 (1st Cir. 2009)).

            A relator can meet this more accommodating standard by

"providing 'factual or statistical evidence to strengthen the

inference    of   fraud    beyond    possibility'      without     necessarily

providing details as to each false claim."            Ge, 737 F.3d at 123-

24 (quoting Duxbury, 579 F.3d at 29) (emphasis added).                    Such

evidence generally includes, inter alia, the "'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.'"                Kelly, 827

F.3d at 13 (quoting Ge, 737 F.3d at 121, 124).

            As the district court noted, "the allegations concerning

[Cyberonics' scheme] are unquestionably adequate to survive a

motion to dismiss."       United States ex rel. Hagerty v. Cyberonics,

Inc., 95 F. Supp. 3d 240, 264 (D. Mass. 2015).             Nonetheless, the

First   Amended   Complaint's       factual    and    statistical     evidence

struggles to connect these allegations with the submission of any

false claims to government programs.

            Hagerty   compares      his   complaint   to   those    we   deemed

adequate in Duxbury and United States ex rel. Escobar v. Universal


                                    - 10 -
Health Servs., Inc., 780 F.3d 504 (1st Cir. 2015), overruled on

other grounds by 136 S. Ct. 1989 (2016).         In Duxbury, the relator

alleged that the defendant-company paid kickbacks to eight named

medical providers, thereby inducing these providers to submit

false claims for reimbursement to Medicare.           Duxbury, 579 F.3d at

30.   Despite being a "close call," we held that the complaint

satisfied Rule 9(b) because "Duxbury ha[d] identified, as to each

of 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., see

also Ge, 737 F.3d at 124 (noting allegations in Duxbury were

"barely adequate" under Rule 9(b)).

          Similarly, in Escobar, we concluded that the relator

satisfied Rule 9(b) by alleging "twenty-seven separate dates on

which claims were submitted in connection with [care provided by

unlicensed and unsupervised personnel], each time including the

relevant billing codes, amount invoiced, and the name of the

[defendant's] staff member who provided the treatment for which

reimbursement   was   sought."     780    F.3d   at    515.    Though   the

allegations concerned claims made in connection with a single

patient's care, we allowed the complaint's other, more general,

allegations to proceed because they stemmed from a "systematic

failure" to enforce licensure and supervision requirements that

necessarily "infected" other claims with fraud.          Id.


                                 - 11 -
             The allegations in Hagerty's First Amended Complaint are

neither as specific as those in Duxbury nor as systematic as those

in   Escobar.      Despite    referencing    a   long   list     of   healthcare

providers who performed and billed for VNS replacement surgeries,

the complaint does not allege whether these providers submitted

reimbursement      claims    to   the   government   for   unreasonable      and

medically unnecessary procedures.            Likewise, the complaint does

not allege how many false claims these providers purportedly

submitted or how Cyberonics' actions caused their submission.               And

though   Hagerty    identifies     several   doctors    and    hospitals   with

patients who had VNS replacement surgeries, he does not allege

that any government healthcare program covered these patients or

that any medical provider submitted claims for reimbursement on

their behalf.

             Similarly, the First Amended Complaint alleged that

Cyberonics employees tried to contact patients about scheduling

VNS replacement surgeries without first consulting their doctor.

The complaint, however, contains no assertion that these efforts

actually resulted in patients scheduling, doctors performing, or

government      healthcare    programs     reimbursing     the    contemplated

surgeries. See Kelly, 827 F.3d at 15 (holding that relators failed

to tie their allegations of misconduct to "specific fraudulent

claims for payment"); Ge, 737 F.3d at 124 (rejecting a "per se

rule that if sufficient allegations of misconduct are made, it


                                    - 12 -
necessarily   follows    that   false     claims    and/or   material   false

information were filed").       Simply put, we cannot infer, based on

the allegations before us, that Cyberonics' actions "infected"

other VNS reimbursement claims with fraud.

            The complaint's most specific allegation comes where

Hagerty states that three healthcare providers, Southbury Training

School,    Monson   Development   Center,     and    Wrentham   Development

Center, had patients who were "seriously disabled" and eligible

for various government healthcare programs, and that the VNS

replacement surgeries conducted on those patients necessarily

resulted in the submission of at least some false reimbursement

claims.    But again, without any allegation that the patients were

actually    covered     by   government     programs    or    that   certain

replacement procedures conducted on these patients were medically

unnecessary, Hagerty has "[a]t most . . . [only] raise[d] facts .

. . suggest[ing] fraud was possible."5        United States ex rel. Rost

v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. 2007), overruled on

other grounds by Allison Engine v. United States ex rel. Sanders,

553 U.S. 662 (2008).



     5  Only one patient from these facilities is actually
identified in the complaint: "F.P.," a Medicare-eligible epileptic
whose VNS device was replaced on May 12, 2010. Paralleling the
broader problems with Hagerty's allegations, there is no
indication that F.P. was an actual Medicare recipient, that his
replacement surgery was unnecessary, or that any false claim was
submitted on his behalf.


                                  - 13 -
             Fighting   an     uphill   battle,     Hagerty    supplements    his

factual allegations with certain statistical allegations which, he

claims, compel the inference he wants us to recognize.                 First, the

complaint    alleges    that    a   majority   of    the    patients   receiving

replacement devices are covered by government healthcare programs

and that approximately half of Cyberonics' revenues came from these

programs.     Second, the complaint estimates that there have been

"over 10,000 medically unnecessary and unreasonable VNS device

replacements" since 2007 and that patients covered by government

healthcare    programs       "account    for   at   least     50-60%   of   these

unnecessary replacements."

             These statements are too broad to be given much weight.

Hagerty does not allege that any particular patient was actually

covered by a government program, provides no basis for his estimate

of 10,000 unnecessary procedures, and does not link Cyberonics'

revenues to these procedures.           Viewed individually or as a whole,

Hagerty's "evidence and arguments proceed more by insinuation than

any factual or statistical evidence that would strengthen the

inference of fraud beyond possibility."             See Kelly, 827 F.3d at 15

(internal marks omitted).           Accordingly, we affirm the district

court's dismissal of Hagerty's First Amended Complaint.

     B. Motion to Amend

             Hagerty also claims that the district court abused its

discretion when it denied his motion to amend the First Amended


                                     - 14 -
Complaint on the basis of undue delay.                Federal Rule of Civil

Procedure     15(a)    provides   that     a    party       may,   in   certain

circumstances, amend a pleading without leave of a court.6               In all

other cases, however, a party may only amend its pleadings with

the opposing party's written consent or the court's leave.                   Fed.

R. Civ. P. 15(a)(2).

             Though courts "should freely give leave when justice so

requires," id., amendments may be denied for several reasons,

including    "undue    delay,   bad   faith,        dilatory   motive   of    the

requesting    party,   repeated   failure      to    cure   deficiencies,    and

futility of amendment,"     Rost, 507 F.3d at 733-34 (citing Foman v.

Davis, 371 U.S. 178, 182 (1962)).        As relevant here, undue delay,

on its own, may be enough to justify denying a motion for leave to

amend.7   Calderón-Serra v. Wilmington Trust Co., 715 F.3d 14, 20


     6 A party may amend a pleading once as a matter of course
within "21 days after serving it," or "if the pleading is one to
which a responsive pleading is required, 21 days after service of
a responsive pleading or 21 days after service of a motion under
Rule 12(b), (e), or (f), whichever is earlier." Fed. R. Civ. P.
15(a)(1).
     7 Hagerty cites to a long list of our decisions, including
Hayes v. New England Millwork Distribs., Inc., 602 F.2d 15, 19
(1st Cir. 1979), and Klunder v. Brown Univ., 778 F.3d 24, 34 (1st
Cir. 2015), which, he claims, requires us to also find that the
delay was prejudicial to the opposing party. Hayes, however, noted
that "[w]hile courts may not deny an amendment solely because of
delay and without consideration of the prejudice to the opposing
party, it is clear that 'undue delay' can be a basis for denial[.]"
602 F.2d at 19 (internal citations omitted). Similarly, although
Klunder states that "[i]n reviewing a district court's decision on
whether or not to grant an amendment, [appellate courts] routinely
focus [their] analysis on the prejudice to the non-moving party,"


                                  - 15 -
(1st Cir. 2013); see also United States ex rel. Wilson v. Bristol-

Myers Squibb, Inc., 750 F.3d 111, 119-20 (1st Cir. 2014). In these

cases, a movant has "[at the very least] the burden of showing

some valid reason for his neglect and delay."          Perez v. Hosp.

Damas, Inc., 769 F.3d 800, 802 (1st Cir. 2014) (quoting In re

Lombardo, 755 F.3d 1, 3 (1st Cir. 2014)) (alteration in original).

In assessing whether a movant has carried this burden, courts must

take into account "[w]hat the plaintiff knew or should have known

and what he did or should have done."       Leonard v. Parry, 219 F.3d

25, 30 (1st Cir. 2000).

           A significant amount of time clearly passed here.      See,

e.g., In re Lombardo, 755 F.3d at 3-4 (discussing cases that

imposed on the movant the burden to explain grounds for delay when

the   delay   was    fourteen,   fifteen,    and   seventeen   months,

respectively).      The district court aptly summarized Hagerty's

listless approach toward amending his complaint as follows:

      Hagerty filed his initial complaint on August 8, 2012.
      He filed the present action on February 4, 2013. After
      Cyberonics filed a motion to dismiss, Hagerty amended
      the complaint on May 19, 2014.      Cyberonics moved to
      dismiss the first amended complaint . . . on June 18,
      2014. The Court ruled on that motion on March 31, 2015.
      Hagerty did not move for leave to file a second amended
      complaint until August 14, 2015. That motion was filed
      (1) more than three years after Hagerty filed the initial
      lawsuit; (2) more than two and a half years after he
      filed the initial complaint . . . ; (3) more than

778 F.3d at 34, its immediate citation to the Hayes language
identified above signifies that we were referring to delay, not
undue delay. Id.


                                 - 16 -
     fourteen months after he filed the first amended
     complaint; (4) more than thirteen months after
     Cyberonics moved to dismiss the first amended complaint;
     and (5) more than four months after the Court's
     memorandum and order on the motion to dismiss.

United States ex rel. Hagerty v. Cyberonics, Inc., 146 F. Supp. 3d

337, 343-44 (D. Mass. 2015).

            Hagerty's   proffered   explanations   for   his   delay   are

twofold.    First, Hagerty argues that the only relevant period of

delay was the four months after the granting of the motion to

dismiss and places responsibility for any delay accruing before

the dismissal squarely on the district court. We can easily reject

this argument, however, because nothing prevented Hagerty from

moving for leave to plead any new information once he became aware

of it.     Where we have excused delay based on the actions of a

district court, it has been because the district court did not

promptly deal with a motion to amend, not because the district

court took its time evaluating a motion to dismiss.       See Farkas v.

Tex. Instruments, Inc., 429 F.2d 849, 851 (1st Cir. 1970).        In the

motion to amend cases, the delay is attributable to the district

court because the motion evidences the movant's proactive approach

to addressing known weaknesses in the First Amended Complaint.

            Second, Hagerty maintains that he could not have known

or anticipated the deficiencies that would form the basis of the

district court's dismissal of his First Amended Complaint.             He

specifically contends that unlike in other cases where the amended


                                - 17 -
complaints were dismissed due to the plaintiff's lack of diligence,

see Acosta-Mestre v. Hilton Intern. of P.R., Inc., 156 F.3d 49, 53

(1st Cir. 1998), he has shown "care and attentiveness" towards

assuaging the district court's concerns about his complaint.             But

Cyberonics' motion to dismiss, filed in June 2014, put Hagerty on

notice of the deficiencies in the complaint, and he made no attempt

to fix these deficiencies until August 2015.                  See Feliciano-

Hernández v. Pereira-Castillo, 663 F.3d 527, 538 (1st Cir. 2011)

(upholding district court's undue delay determination where motion

to amend was filed "nearly a year after the motion to dismiss was

filed"); ACA Fin. Guaranty Corp. v. Advest, Inc., 512 F.3d 46, 57

(1st   Cir.    2008)    ("Plaintiffs    may   not,    having     the   needed

information, deliberately wait in the wings . . . with another

amendment to a complaint should the court hold the first amended

complaint     was   insufficient.      Such   an   approach    would   impose

unnecessary costs and inefficiencies on both the courts and party

opponents.").

            Thus, we conclude both that Hagerty did not meet his

burden of providing a valid reason for his delay and that the

district court did not abuse its discretion in denying his motion

for leave to amend.

                             III. Conclusion

            The judgment of the district court is AFFIRMED.




                                    - 18 -
