Court Opinion

ID: 2671865
Source: CourtListenerOpinion
Date Created: 2014-05-01 00:00:19.290671+00
Date Added: 2024-06-11T13:05:30.185975
License: Public Domain

United States Court of Appeals
                       For the First Circuit

No. 13-1948

              UNITED STATES ex rel. MICHAEL A. WILSON,

                        Relator, Appellant,

                                 v.

      BRISTOL-MYERS SQUIBB, INC.; SANOFI-AVENTIS U.S. LLC,

                       Defendants, Appellees.

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

              [Hon. Mark L. Wolf, U.S. District Judge]

                               Before

                        Lynch, Chief Judge,
               Torruella and Howard, Circuit Judges.

     Alastair J.M. Findeis, with whom Milberg LLP and David Pastor
and Pastor Law Office, LLP were on brief, for appellant.
     Catherine E. Stetson, with whom Jessica L. Ellsworth, Mitchell
J. Lazris, Mary Helen Wimberly, Hogan Lovells US LLP, Robert Keefe,
and WilmerHale were on brief, for appellee Bristol-Myers Squibb,
Co.
     Robert J. McCully, with whom Elizabeth C. Burke and Shook,
Hardy & Bacon LLP were on brief, for appellee Sanofi-Aventis U.S.
LLP.

                           April 30, 2014
           LYNCH, Chief Judge.       This appeal primarily involves the

scope of the first-to-file rule of the federal False Claims Act

("FCA"), 31 U.S.C. § 3730(b)(5), and the application of the

"essential facts" test to determine whether a later-filed complaint

is barred by earlier-filed complaints under this provision.             See

United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579
F.3d 13, 32-33 (1st Cir. 2009).

           Relator Michael A. Wilson, a former Bristol-Myers Squibb,

Co. ("BMS") sales representative, alleged that BMS and Sanofi-

Aventis U.S., LLC ("Sanofi") unlawfully promoted Plavix for off-

label   uses,   that   BMS   also   unlawfully   promoted   Pravachol   and

Monopril, and that both companies "knowingly" caused the submission

of false claims to the government in violation of the FCA.              See

United States ex rel. Hutcheson v. Blackstone Med., Inc., 647 F.3d
377, 380 (1st Cir. 2011).           After the government (and Wilson)

benefitted from the settlement of certain claims Wilson brought in

his original complaint against BMS, the government declined to

intervene in the litigation of the remaining claims.         The district

court dismissed the remaining FCA claims as expressed in a Second

Amended Complaint because they ran afoul of the first-to-file rule.

           Wilson now appeals from the dismissal, as well as from

the denial of his motion to file a Third Amended Complaint and from

denial of his follow-up motion to reconsider.         We affirm.

                                     -2-
                                   I.

A.            Background and First Amended Complaint

              Wilson's employment at BMS was terminated in September

2004.       In September 2006, he filed his original FCA complaint in

the Central District of California under seal, to allow the United

States time to review the complaint and to decide whether to

intervene in the action, 31 U.S.C. § 3730(b)(2).         He filed an

amended complaint ("First Amended Complaint" or "FAC") in October

2006, which alleged, inter alia,1 that BMS violated the federal

criminal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b)(2)(B), and

engaged in off-label promotion of Monopril, Plavix, and Pravachol,

and that these actions caused false claims to be submitted to the

government in violation of the FCA.         Physicians may prescribe

Plavix, Pravachol, and Monopril for non-FDA-approved indications,

but the Food, Drug and Cosmetic Act, 21 U.S.C. § 321 et seq.,

prohibits companies from marketing medications for such "off-label"

uses,2 and Medicaid generally does not reimburse patients for off-

        1
         Wilson's FAC also alleged that BMS retaliated against him
and terminated his employment unlawfully. Those employment-related
claims have been transferred to California and are not before us in
this appeal. United States ex rel. Wilson v. Bristol-Myers Squibb,
Inc., No. 06-12195-MLW, 2013 WL 3327317, *3-4 (D. Mass. June 27,
2013).
        2
          The FDA approves drugs to treat particular medical
conditions or diseases.     Off-label use marketing is for those
conditions or diseases not included in the official label approved
by the FDA. In re Neurontin Mktg. & Sales Practices Litig., 712
F.3d 21, 27-28 (1st Cir. 2013). At times the drugs in question may
be potentially harmful to patients when put to off-label uses. Id.

                                   -3-
label prescriptions. See 42 U.S.C. § 1396r-8(k)(3), (k)(6); United

States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 723 (1st Cir.

2007), overruled in part by Allison Engine Co. v. United States ex

rel. Sanders, 553 U.S. 662 (2008).

          In December 2006, while the government's investigation

was ongoing and the FAC was still under seal, the case was

transferred to the District of Massachusetts.

          On September 28, 2007, Wilson entered into a partial

settlement agreement with BMS that concluded part of the case.

Under the agreement, Wilson voluntarily dismissed with prejudice

all federal FCA claims against BMS "except for claims relating to

off-label promotion, retaliation, and wrongful termination to the

extent they are alleged in Paragraphs 3-6, 9-60, 161-174, 176-178,

180, and 190-191 of the [FAC]."    In the settlement, BMS denied any

liability or wrongdoing related to Wilson's allegations, but agreed

to execute an agreement with the United States, under which BMS

would pay the government $317,436,081, plus 4.5% per year interest

from January 1, 2007 until the settlement amount was paid in full.

Wilson received a portion of that sum.

          On October 22, 2008, the government declined to intervene

in what remained of the case.

at 27.

                                  -4-
B.        Second Amended Complaint

          On   April   9,   2009,   Wilson   filed   his   Second   Amended

Complaint ("SAC"), also under seal. The SAC expanded upon Wilson's

earlier (not settled) allegations against BMS, and added Sanofi as

a defendant for the first time.      The SAC alleged that BMS engaged

in schemes to promote Plavix, Pravachol, and Monopril for certain

off-label uses, and that Sanofi participated in those schemes that

related to the promotion of Plavix only.        It is the dismissal of

this complaint which is primarily at issue.

          More specifically, the SAC alleged that (1) BMS promoted

Pravachol, a drug the FDA had approved for lowering cholesterol,

for off-label uses related to diabetes or insulin resistance

syndrome; (2) BMS and Sanofi promoted Plavix, a drug the FDA had

approved for lowering the risk of stroke and heart attack for

patients with atherosclerosis or acute coronary syndrome, for off-

label use by diabetic patients to prevent peripheral arterial

disease ("PAD"); and (3) BMS engaged in the off-label promotion of

Monopril, which the FDA approved to treat hypertension.

          As to the mechanisms of the off-label promotions, Wilson

alleged that BMS used the following schemes to promote Plavix and

Pravachol: (1) sponsoring and promoting off-label research for

these drugs; (2) training its sales force to promote off-label

                                    -5-
prescriptions, including using altered "fax back" requests;3 and

(3)   promoting   off-label   uses   in    continuing   medical   education

programs.   He alleged that Sanofi used the same methods to promote

off-label use of Plavix.      Finally, Wilson alleged that BMS trained

its representatives to promote off-label prescriptions of Monopril.

            In August 2009, the court granted a motion to unseal the

case. At this point, the parties agreed, with court approval, that

because Wilson intended to amend his complaint again, BMS and

Sanofi did not need to answer it until the court determined which

complaint would govern.

C.          Denial of Leave to File Third Amended Complaint

            On June 24, 2010, Wilson filed a Motion for Leave to

Amend and File a Third Amended Complaint, and attached his Proposed

Third Amended Complaint ("TAC") to the motion.          The TAC sought to

add a second relator, Lucius O. Allen, Jr., also a former BMS

employee, and to substantially expand the allegations in the SAC.

            The court (Gertner, J.) denied Wilson's motion on June

16, 2011, reasoning in a thoughtful opinion that the TAC did not

meet the requirements for amendment of Fed. R. Civ. P. 15, and

      3
         A pharmaceutical company may distribute "third party"
publications that describe results of off-label uses of their
drugs, but only if the material is distributed in response to
requests from physicians. See 21 C.F.R. § 99.101. At BMS, these
"requested" materials were referred to as "faxbacks."      Wilson
alleged that BMS "sales representatives fraudulently altered
faxback requests to make the promotion of off-label prescriptions
look legitimate."

                                     -6-
further, that the substance of the TAC did not, in any event, meet

the requirements of the FCA.          As to Rule 15, the district court

noted that the SAC came almost three years after the original

complaint, with the TAC following almost a year after the SAC, and

found that Wilson "ha[d] not adequately explained" either set of

delays.

             The   district   court   relied       more   heavily   on   its   FCA

inadequacy    holding.        It   found    that    to    the   extent   Allen's

allegations replicated claims that Wilson made in the SAC, the TAC

violated the "first-to-file" rule, 31 U.S.C. § 3730(b)(5), or the

"public disclosure" bar, id. § 3730(e)(4)(B), of the FCA.                       By

contrast, to the extent that the TAC added substantively new

allegations not previously disclosed to the government (regardless

of which relator provided the information), the district court held

that those allegations violated the qui tam filing and service

requirements, id. § 3730(b)(2).4

D.           Denial of Motion to Reconsider

             In anticipation of Judge Gertner's retirement, the case

was reassigned to Judge Wolf on June 21, 2011.                  Wilson filed a

Motion for Reconsideration of the denial of his motion to file the

     4
        The FCA requires that a relator filing a new claim must
serve "substantially all material evidence and information the
person possesses" on the government, and that the complaint must
remain under seal for at least 60 days. 31 U.S.C. § 3730(b)(2).
The TAC was not filed under seal and was not served on the
government before it was filed.

                                      -7-
TAC.       This motion disputed the Rule 15 ruling, but did not dispute

the earlier ruling that new allegations based on Allen's knowledge

could not be added to the TAC.          Instead, Wilson requested that the

court allow the SAC to be amended by "adding certain paragraphs"

from the Proposed TAC that were, Wilson represented, based on his

own knowledge and investigation.5

               The court denied the motion on March 7, 2012, finding

that this was not one of the "limited number of circumstances,"

United States v. Allen, 573 F.3d 42, 53 (1st Cir. 2009), in which

reconsideration was warranted. The district court ordered both BMS

and Sanofi to respond to the SAC.

E.             Motion to Dismiss the FCA Claims in the SAC

               BMS and Sanofi moved to dismiss the FCA counts in the

SAC.       At a hearing on February 7, 2013, the district court granted

the motions as to Wilson's federal FCA claims. The court dismissed

the FCA claims relating to Plavix and Pravachol for lack of subject

matter      jurisdiction,   Fed.   R.   Civ.   P.   12(b)(1),   because   they

violated the FCA's first-to-file rule, see 31 U.S.C. § 3730(b)(5).

It dismissed the Monopril allegations for failure to plead fraud

with particularity.       Fed. R. Civ. P. 9(b).      Wilson does not appeal

       5
       Along with his motion for reconsideration, Wilson belatedly
submitted a declaration from his attorney that purported to address
which of the allegations in the Proposed TAC were based on Wilson's
(rather than Allen's) knowledge. He offered no such distinction to
the district court when he first sought leave to file the TAC.

                                        -8-
the district court's dismissal of the FCA claims related to

Monopril.

            The court's dismissal on first-to-file grounds was based

on two complaints that were filed before Wilson filed his original

complaint in September 2006. On May 4, 2006, Daniel C. Richardson,

a Senior District Business Manager for BMS, had filed a complaint

under seal in the District Court for the District of Columbia. The

Richardson Complaint alleged that BMS and Sanofi engaged in broad,

nationwide schemes to promote and prescribe Plavix and Pravachol

for off-label uses. His allegations extended from "1999 through at

least 2003, and probably thereafter."

            More specifically, the Richardson Complaint alleged that

BMS and Sanofi promoted Plavix for off-label treatment of acute

coronary syndrome,6 and promoted Pravachol, which was approved for

reducing    cholesterol   and   cardiac     events,   for   uses    "such    as

decreasing CD-40 ligand, decreasing matrix metalloproteinases,

decreasing    hsCRP   levels    and     other   mechanisms    for    'plaque

stabilization' not included in the FDA-approved label."                     The

Richardson Complaint alleged that BMS and Sanofi used several

mechanisms to promote these off-label uses,7 including the schemes

     6
       The FDA approved Plavix for the treatment of acute coronary
syndrome in February 2002; however, the Richardson Complaint's
allegations of BMS and Sanofi's promotion of this off-label use
covered the period before the FDA approved it.
     7
       The Richardson Complaint also alleged that BMS and Sanofi
paid "tens of thousands of dollars in kickbacks to Medicare and

                                      -9-
of "target[ing] hospitals and . . . follow[ing] up on medical

education and [Continuing Medical Education] programs," using "fax

back[s]" to send off-label information, sponsoring research of off-

label uses, and training its sales forces to promote those uses.

           A   second    relevant   complaint     was   filed   by   Joseph

Piacentile in the District of New Jersey on June 7, 2005 against

Sanofi.   That complaint alleged that Sanofi paid illegal kickbacks

to physicians in order to push them to prescribe Plavix for certain

off-label uses.    Because Wilson had earlier sought to withdraw his

allegations as to illegal kickbacks,8 the Piacentile Complaint, the

court concluded, was ultimately "not material to the outcome."

           The court noted that the off-label promotions and schemes

alleged in the SAC were substantially similar to those alleged in

the Richardson Complaint. Both complaints referred to promotion of

off-label uses as to the same drugs, and both alleged the use of

certain mechanisms -- among them, faxbacks and off-label marketing

through continuing medical education -- to further these schemes.

The   difference   was   the   off-label   uses   --    the   treatment   of

Medicaid providers, causing the providers to falsely certify that
they ha[d] complied with the anti-kickback provisions when in fact
they had not." We do not dwell on this portion of the Richardson
complaint.
      8
         Wilson's allegations regarding illegal kickbacks were
barred by the settlement agreement and accompanying release of
claims that Wilson signed in September 2007.

                                    -10-
particular diseases and symptoms -- for which Plavix and Pravachol

were promoted.

             The district court applied the "essential facts" test to

determine whether the SAC violated the FCA's first-to-file rule, as

set forth in United States ex rel. Duxbury v. Ortho Biotech

Products, L.P., 579 F.3d 13, 32 (1st Cir. 2009). It concluded that

the   only   new   information   contained   in   Wilson's   SAC   was   the

particular off-label uses for treatment of different diseases that

BMS and Sanofi were promoting.        Because "Wilson's complaint d[id]

not alert the government to a new type of fraudulent scheme or even

new aspects of an existing scheme allegedly being perpetrated by

the defendants," the court reasoned, it was barred by the FCA's

first-to-file rule.     Accordingly, the district court dismissed the

FCA claims in the SAC as to Plavix and Pravachol.             This appeal

followed.

                                   II.

             The FCA first-to-file rule is jurisdictional, and we

review a dismissal on those grounds de novo. United States ex rel.

Heineman-Guta v. Guidant Corp., 718 F.3d 28, 34 (1st Cir. 2013).

The rule comes from the statutory prohibition that bars any "person

other than the Government" from "bring[ing] a related action based

on the facts underlying the pending action" in the FCA context. 31

U.S.C.   §   3730(b)(5)   (emphasis    added).     This   prohibition     is

"exception-free."     Duxbury, 579 F.3d at 33 (quoting United States

                                   -11-
ex rel. Lujan v. Hughes Aircraft Co., 243 F.3d 1181, 1187 (9th Cir.

2001)) (internal quotation marks omitted).

            One underlying purpose of § 3730(b)(5) is "to provide

incentives to relators to 'promptly alert[] the government to the

essential facts of a fraudulent scheme,'" id. at 24 (alteration in

original) (quoting Lujan, 243 F.3d at 1188).       It is also part of

the larger balancing act of the FCA's qui tam provision, which

"attempts   to   reconcile   two   conflicting   goals,   specifically,

preventing opportunistic suits, on the one hand, while encouraging

citizens to act as whistleblowers, on the other." United States ex

rel. LaCorte v. SmithKline Beecham Clinical Labs., Inc., 149 F.3d
227, 233 (3d Cir. 1998); see also United States ex rel. Ge v.

Takeda Pharm. Co., 737 F.3d 116, 123 (1st Cir. 2013) (while the

FCA's financial incentives encourage would-be whistleblowers to

expose fraud, they also attract "parasitic relators who bring FCA

damages claims based on information within the public domain or

that the relator did not otherwise discover" (quoting United States

ex rel. Duxbury v. Ortho Biotech Prods., L.P. ("Duxbury II"), 719
F.3d 31, 33 (1st Cir. 2013)); United States ex rel. Chovanec v.

Apria Healthcare Grp., Inc., 606 F.3d 361, 363-64 (7th Cir. 2010);9

     9
         As to such parasitic suits, as the Seventh Circuit
(Easterbrook, J.) has observed:
     Me-too suits designed to divert some of the reward to
     latecomers do not serve any useful purpose, and they
     weaken the incentive to dig out the facts and launch the
     initial action. What's more, secondary suits that do no
     more than remind the United States of what it has learned

                                   -12-
Lujan, 243 F.3d at 1187. The application of the first-to-file rule

advances both functions of § 3730(b)(5).       See LaCorte, 149 F.3d at

233.

           We   "have   interpreted   §   3730(b)(5)   to   bar   'a    later

allegation [if it] states all the essential facts of a previously-

filed claim' or 'the same elements of a fraud described in an

earlier suit.'"    Duxbury, 579 F.3d at 32 (alteration in original)

(quoting LaCorte, 149 F.3d at 232-33).        In using this judicially

created "essential facts" or "material elements" test, which we

adopted for the first time in Duxbury, 579 F.3d at 32-33, we are in

line with all of the circuit courts which have considered this

section.   See LaCorte, 149 F.3d at 232-33; United States ex rel.

Carter v. Halliburton Co., 710 F.3d 171, 181-82 (4th Cir. 2013);

United States ex rel. Branch Consultants v. Allstate Ins. Co., 560
F.3d 371, 378 (5th Cir. 2009); Walburn v. Lockheed Martin Corp.,

431 F.3d 966, 971 (6th Cir. 2005); Chovanec, 606 F.3d at 363-64;

Lujan, 243 F.3d at 1187-88; United States ex rel. Grynberg v. Koch

Gateway Pipeline Co., 390 F.3d 1276, 1279-80 (10th Cir. 2004);

United States ex rel. Hampton v. Columbia/HCA Healthcare Corp., 318
F.3d 214, 217-18 (D.C. Cir. 2003).

           Under the essential facts standard (with exceptions not

relevant here), the first-to-file rule "still bar[s] a later claim

     from the initial suit deflect recoveries from                the
     Treasury to rewards under [31 U.S.C.] § 3730(d).
Chovanec, 606 F.3d at 364.

                                  -13-
'even if that claim incorporates somewhat different details,'"

Duxbury, 579 F.3d at 32 (quoting LaCorte, 149 F.3d at 233).     That

is because "once the government knows the essential facts of a

fraudulent scheme, it has enough information to discover related

frauds." Branch Consultants, 560 F.3d at 378 (quoting LaCorte, 149
F.3d at 234) (internal quotation marks omitted).

           The plain statutory text is the basis for the judicially

crafted essential facts rule and is the reason we do not use an

"identical facts" rule.   "[E]arlier-filed complaints must provide

only the essential facts to give the government sufficient notice

to initiate an investigation into allegedly fraudulent practices."

Heineman-Guta, 718 F.3d at 36-37.      Section 3730(b)(5) bars later

"related action[s]" based on the same underlying facts; it does not

require that the actions be identical for the rule to come into

play.   It "would be contrary to the plain language and legislative

intent" of the first-to-file rule to impose an "identical facts"

test.   Lujan, 243 F.3d at 1189.

           This reading is consistent with the purpose of the qui

tam provision, which allows private parties to bring actions in

order "to reduce fraud against the government." Heineman-Guta, 718
F.3d 36.   In light of that purpose, 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."   Id.

                                -14-
             The Richardson Complaint put the government on notice of

allegations that BMS (and Sanofi with respect to Plavix) was

engaged in a systematic, nationwide scheme (not rogue actors)10 to

promote Plavix and Pravachol for named off-label uses. Those named

particular uses were identified with an introductory "such as."

The complaint, which covered several of the same years as Wilson's

SAC, identified particular mechanisms used for promotion, and

alleged    that     the   scheme   caused     the    submission   of    "tens   of

thousands" of false claims to the government.             Those mechanisms of

promotion, alleged first in the Richardson Complaint, included the

use   of    faxbacks,     targeting   of     continuing    medical     education

programs,     and    training      sales    representatives       in   off-label

promotion.

             The overlaps among the two complaints were considerable:

the same defendants, the same drugs, the assertion of nationwide

schemes, and the allegations of specific mechanisms of promotion

common to both and leading to common patterns of submission of

false claims under the federal Medicaid program.

             The    differences     between    the    first-filed      Richardson

Complaint and the SAC were that the Richardson Complaint referred

to promotion of off-label uses of the two same drugs, but tied to

      10
         We are not faced with the pure question of whether
differences in location alone are enough to make schemes so
dissimilar as not to invoke the first-to-file rule. Obviously, the
materiality of such distinctions must be determined on a case-by-
case basis.

                                      -15-
certain diseases and symptoms for Plavix (treatment of acute

coronary syndrome) and for Pravachol (decreasing CD-40 ligand and

hsCRP levels), while the SAC referred to promotion of off-label

uses for different diseases and symptoms (for Plavix, for use by

diabetic patients to treat symptoms associated with PAD, and for

Pravachol, for uses related to diabetes or insulin resistance

syndrome). While the results of the essential facts test must vary

with the facts of each case, those differences are not enough to

reasonably conclude the earlier Richardson Complaint was not a

related claim to the government based on the facts.              Whether the

first   complaint   results   in   there   being   an   actual    government

investigation and whether any such investigation extends to off-

label uses to treat different diseases is not the point.

           Wilson argues that our opinion in Duxbury counsels the

opposite result.     Not so, for several reasons, including that

Duxbury supports our conclusion.      Duxbury's original complaint was

the first one filed that alleged particular FCA violations relating

to Procrit, but it did not allege an off-label promotion and

marketing scheme.     We rejected his argument that the off-label

promotion and marketing schemes that he added in his first amended

complaint were not barred even though another relator (Blair) had

filed a complaint in the period between Duxbury's original and

first amended complaints.     Duxbury, 579 F.3d at 32-33.          Duxbury's

original complaint relied on a single drug study "and nowhere

                                   -16-
refer[red]     to   an   'off-label'    promotion    scheme."         Id.   at   33

(emphasis added). By contrast, Blair's complaint alleged a complex

off-label promotion and direct marketing scheme. We concluded that

Duxbury's original complaint "[could] not trump the Blair Complaint

for purposes of the 'first-to-file' rule."            Id.

             By contrast here, the Richardson Complaint and the SAC

allege   a   set    of   the   same   off-label    promotion    mechanisms       or

channels, and so Duxbury's holding was dealing with a different

problem.     Once the government is equipped with allegations that

detail   the   drugs     and   mechanisms     of   wrongdoing    as    to   those

particular medications, it is able to "initiate an investigation,"

Heineman-Guta, 718 F.3d at 37, into those channels.

             Wilson's reading of § 3730(b)(5) would transform our

"essential facts" test into an already rejected "identical facts"

test. That interpretation of the first-to-file rule is contrary to

our precedent, see Duxbury, 579 F.3d at 32, and to the views of at

least four other circuits. See LaCorte, 149 F.3d at 233 (rejecting

an "identical facts" test that would "bar only suits alleging facts

identical to those in previous actions"); see also United States ex

rel. Poteet v. Medtronic, Inc., 552 F.3d 503, 516 (6th Cir. 2009)

(adopting LaCorte approach); Hampton, 318 F.3d at 217-18 (same);

Lujan, 243 F.3d at 1188-89 (same).

                                       -17-
                                    III.

           We also affirm the rejections of Wilson's efforts to cure

the ills of his SAC through formal motions to amend and less formal

requests that portions of his Proposed TAC survive.           We affirm the

initial denial of his motion for leave to file the TAC, along with

the later rejection of his motion to reconsider.

           Review of the denial of a motion to amend is for abuse of

discretion.     Ge, 737 F.3d at 127.          We "defer to the district

court's hands-on judgment so long as the record evinces an adequate

reason for the denial."       Aponte-Torres v. Univ. of P.R., 445 F.3d
50, 58 (1st Cir. 2006).

           As to the denial of his motion for leave to file the TAC,

we affirm on both grounds asserted by the district court.            Undue

delay is a permissible ground for denying leave to amend, Foman v.

Davis, 371 U.S. 178, 182 (1962), and when "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,"   Nikitine   v.

Wilmington Trust Co., 715 F.3d 388, 390-91 (1st Cir. 2013) (quoting

Hayes v. New Eng. Millwork Distribs., Inc., 602 F.2d 15, 19-20 (1st

Cir. 1979)) (internal quotation marks omitted).           Wilson did not

meet his burden of explaining the delay before the district court.

           The Proposed TAC was filed over a year after the SAC and

nearly four years after the start of the case.        And even before the

                                    -18-
SAC was filed, portions of the case had been settled and the

government had investigated and declined to intervene on the

remaining claims. Motions to amend "require[] the court to examine

the totality of the circumstances and to exercise its informed

discretion in constructing a balance of pertinent considerations."

Palmer v. Champion Mortg., 465 F.3d 24, 30-31 (1st Cir. 2006). The

district   court's   undue    delay     determination   was   eminently

reasonable.11

           As to the ruling the TAC failed under FCA requirements,

Wilson disputes only the district court's attribution of some

portion of the new allegations in the TAC to Allen, the new

relator.   The argument is gone.   It was Wilson who made no attempt

to differentiate the allegations that came from him from the ones

that came from Allen.        There was no reason for the court to

conclude otherwise than that the new paragraphs in the Proposed TAC

were attributable to the new relator12 and so conclude that they

     11
        Wilson argues that the delay in filing the TAC was a result
of the length of the government's investigation and the
accompanying length of the seal period. Whether or not that could
ever justify delay, the argument is undermined by the timeline in
the case. The government declined to intervene in October 2008,
but the Proposed TAC was not filed until June 2010. Cf. Nikitine,
715 F.3d at 391 (affirming dismissal on undue delay grounds where
"the plaintiff allowed nearly a year to elapse before seeking to
amend his complaint and proffered no good reason for the delay").
     12
          We also reject Wilson's claim that the district court
should have allowed the Proposed TAC "with the caveat that Allen
not be included." He sought the wholesale filing of the TAC, and
it was not an abuse of discretion for the district court to decline
to fashion sua sponte a limited grant of his motion to amend.

                                 -19-
violated the FCA's filing and service requirements.   See 31 U.S.C.

§ 3730(b)(2).

          Finally, as to his appeal from the denial of his motion

for reconsideration, Wilson's arguments fail.     Not only is his

appeal reviewed for abuse of discretion, Ge, 737 F.3d at 127, but

"[f]or such a motion to succeed, 'the movant must demonstrate

either that newly discovered evidence (not previously available)

has come to light or that the rendering court committed a manifest

error of law.'" Mulero-Abreu v. P.R. Police Dep't, 675 F.3d 88, 94

(1st Cir. 2012) (quoting Palmer, 465 F.3d at 30).      There is no

assertion these grounds are met, only that there was a manifest

error of law.   As we have reasoned, the district court was correct

in rejecting the TAC.

                                IV.

          The judgment of the district court is affirmed.    Costs

are awarded to appellees.   So ordered.

                                -20-