*1 рrovided evidence about the criminal A Government mastermind.”40 district court free to Amieva-Rodriguez analyze remains a defendant’s in- degree which organized activity, dispensable so that or planned along or essential role with other considerations. factor is neutral. * * *
Amieva-Rodriguez did offer evi culpability participants dence judg- We AFFIRM the district court’s smuggling operation other than drug ment. who, him, agreed transport those like marijuana fashioned a means of
breaching the States border. There United Amieva-Rodriguez
is no evidence culpable partici less than the others who pated transporting marijuana with him in across the Rio Grande River. Similar facts UNITED rel. STATES America ex United States v. Torres- present were Joseph Ed Ibanez and Jennifer Hernandez, in which we observed that wards, Relators-Appellants, only regard the record “[t]he evidence ing pos of others in participation kilograms marijuana session the 95 SQUIBB BRISTOL-MYERS COMPA pertains for distribution the other indi NY; Otsuka America Pharmaceuti transpоrted drugs viduals who had on cal, Inc., Defendants-Appellees. respective their backs.”37 concluded in We No. 16-3154 that ease that the defendant “was no more or than culpable transport less the other United of Appeals, States Court any ers. He did offer evidence Sixth Circuit. participation, participation, expected growing, in the others involved further Argued: December transportation, or intended sale of this Decided and Filed: October marijuana.”38 court’s The district failure Rehearing En Banc Denied agree Amieva-Rodriguez that he was 3, 2018* January “substantially culpable less the aver than age participant activity” in the criminal clearly finding.
was not erroneous factual a. Although the district based part Amieva-Rodriguez’s its decision role, says “instrumental” Amendment 794 indispensable that a defendant’s role is not dispositive.39 The Amendment does not right [mitigat “provide an affirmative ing-role] every actor reduction but the 2016). Gomez-Valle, F.3d 203, (5th Cir. States v. 40. United 2016). 324, 331 Id. * Judge partic- White recused herself from (Nov. 1, aрp. sup., 39. U.S.S.G. C amend. 794 ruling. ipation in this 2015).
ARGUED: C. Meyers, William LTD., Goldberg Chicago, Illinois, Kohn Ellsworth, Relators. Jessica L. Hogan Lo- LLP, D.C., vells Washington, Ap- US pellee Bristol-Myers Squibb. Jennifer L. Skadden, Spaziano, Slate, Arps, Meagher LLP, D.C., Flom Washington, & Ap- pellee Otsuka. ON BRIEF: C. William Chizewer, Meyers, David J. Emily Gil- D. man, LTD., Goldberg Kohn Chicago, Illi- nois, Jennifer Verkamp, M. Frederick M. Jr., Morgan, Napora, Chandra Morgan LLC, Cincinnati, Ohio, Verkamp for Rela- Ellsworth, Jessica tors. L. Mitchell J. Lazris, Sokoloff, Eugene Hogan A. Lovells LLP, D.C., Washington, US for Appellee Bristol-Myers Squibb. Jennifer L. Spazi- ano, Ettinger, Mitchell S. Caroline Van Zile, Skadden, Slate, Arps, Meagher & LLP, D.C., Washington, Flom Daniel E. Izenson, Hankinson, F. Keating Thomas PLL, Muething Klekamp, Cincinnati, & Ohio, for Appellee Otsuka. McKEAGUE, KETHLEDGE,
Before: STRANCH, Judges. Circuit McKEAGUE, J., opinion delivered the KETHLEDGE, J., of the court in which STRANCH, J., joined, joined part. STRANCH, 922-26), (pp. J. delivered a separate opinion concurring part dissenting in part.
OPINION McKEAGUE, Judge. Circuit Joseph Relators and Jennifer Ibanez Edwards, employees former Bristol- (BMS), Myers bring qui Co. this Squibb BMS, alleging together tom action that Pharmaceutical, with Otsuka America Inc. (Otsuka), complex, engaged in a nation- promote to improperly wide scheme antipsychotic drug Ability. Relators assert claims for reim- scheme caused drug for bursement to be submitted government, in violation the False et (FCA), improperly § induced 31 U.S.C. assert that defendants Act Claims prescribe Abilify through re- analogues. providers seq., and several state-law in complaint in munerations and benefits violation district dismissed the Anti-Kickback Statute. Relators assert subsequently relators’ mo- part denied and requests government for reimburse- to amend. Because neither second tion pre- prescriptions for off-label and proposed nor the third ment complaint amended 9(b)’s kickbacks constitute scriptions by induced complaint satisfies amended false claims under the FCA. affirm the requirements, we dis- pleading trict court’s orders. allegations These come the heels nearly allegations identical
set leveled I against years nine BMS and Otsuka some into a earlier. BMS entered five- Background A. Factual year Corporate Intеgrity Agreement as have sold BMS and Otsuka Since qui part settlement of a toro action drug Abilify. Both rela- and marketed the improper promotion of also involved which Joseph tors and Jennifer Edwards Ibanez into Abilify. In Otsuka entered its representatives mar- worked as sales BMS five-year Corporate Integrity Agree- own keting from 2005 to 2010. Abilify qui tarn yet a result of another ment as Abilify antipsychotic drug ap- is an alleging action the same misconduct. The uses proved prescriptive for various agreements language used similar two approved It adult uses. It FDA. has three to adopt proce- require Otsuka BMS in schizophrenia to treat approved was' programs designed to ensure dures and 2002; Bipolar symptoms FCA, to treat related compliance with the the Anti-Kick- 2004; supplemental I in as a Statute, Disorder promotion and cease off-label back in major depressive treatment for that, disorder allege Abilify. despite The relators Abilify approved has three uses also agreements, companies those the two con- approved It pediatrics. treat promote Abilify of- tinued off-label and 2007; schizophrenia year-olds in in physicians prescribed kickbacks to who fer symptoms Bipolar with treat associated it. years in patients I to 17 old Disorder
2008; Background irritability associated B. Procedural and to treat patients autistic to 17 disorder brought this action under the Relators expressly There no years old are seq., et Act, § False Claims 31 U.S.C. 3729 elderly disapproved pa- treatments twenty-eight analogues state-law after tients, FDA has included a warn- but the government, which de- disclosure Abilify associated ing since 2007 Specifically, to intervene. the com- clined elderly mortality rate with increased alleges illegal pro- that defendants’ plaint psychosis. patients with dementia-related Abilify government motion of caused the of 31 pay prescriptions boils off-label violation
Relators’ FCA down *8 3729(a)(1)(A). First, § complaint al- The fur- separate theories. relators U.S.C. two that, compa- allegеs part ther as of these fraudu- lege pharmaceutical defendant schemes, Anti- engaged encourage in nies a scheme lent defendants violated Statute, 1320-7b(b); § Abilify for providers prescribe unap- Kickback U.S.C. (“off-label”) of false records uses and that some of caused the use creation proved claims, paid for material to false 31 U.S.C. prescriptions those off-label were Second, 4729(a)(1)(B); § failed reimburse by government programs. overpayments, for id. II United States 3729(a)(1)(G); conspired § to violate the A. Jurisdiction FCA, 3729(a)(1)(C); § id. and that BMS The jurisdiction district court had against Ibanez and retaliated Edwards over claims arising under the False company’s alleged internally reporting the pursuant Act claims Claims to 28 U.S.C. comply failure to and federal state 3732(a). § The district court certified its Corporate Integrity Agree- laws and the partially order granting defendants’ Rule 3730(h). ments, §id. 12(b)(6)motion and denying its order rela- response 15(a)(2) to relators’ second amended tors’ Rule motion under Fed. R. 54(b). 54(b) complaint, defendants filed Civ. P. “Although motions dis- Rule relaxes 12(b)(6). finality requirement the traditional pursuant ap miss R. Civ. P. Fed. review, pellate it does not tolerate imme granted The district court Otsuka’s motion appeal of dismiss, every diate action taken granted part in and denied Acquisition, district court.” Gen. Inc. v. motion, part dismissing all of BMS’s Inc., (6th GenCorp, 1022, result, qui only tarn claims. As a 1994). challenges Cir. party Neither claims survived were the retaliation jurisdiction court’s hear certified brought against claims BMS and Edwards’ Nonetheless, on appeal. orders we must analogue. Arizona-employment claim The still satisfy ourselves that certification supplemental ju- court declined to exercise Otherwise, jurisdic was proper. appellate remaining risdiction over the state law lacking. Lowery tion is Express v. Fed. Proceedings claims. continued dis- 2005). Corp., 426 F.3d trict court on the retaliation claims. The district court’s determination However, relators moved to file a third proper that certification has two com was complaint under R. Civ. аmended Fed. P. First, entry judgment of final ponents. 15(a)(2), proposed and attached the com- to one or more but fewer than all of the plaint. par- The district court directed the second, parties; claims or there changes ties to the com- address made just delay. compo no first reason plaint potentially implicating that it saw as nent is reviewed de novo and the second public-disclosure Following the FCA’s bar. for abuse of discretion. Id. at 821. responsive filings, pub- the court found the many precluded lic-disclosure bar The district court’s orders collec com- amendments and that amended tively litigation qui ended the relators’ plead present- plaint otherwise failed BMS, tam claims leav against Otsuka and adequate particularity ment with to sur- ing only personal, employment- relators’ 12(b)(6) motion. Accordingly, vive Rule claims against based BMS. See retaliation the court relators’ motion to file a denied I, 1228; Op. R. Dist. Ct. PID R. third amended on the basis II, PID no Op. Dist. Ct. 2168. There was futility. subsequently granted The court deeming еrror in these orders final. That 54(b) staying litigation motion on the is, might develop no matter how the record granting judg- claims final retaliation proceedings in further on the unresolved BMS, ment certification on both the order resolv- against claims retaliation there are ing partial motion dismiss and grounds no on which the dismissed Second, denying subject order the motion to amend. Rela- to reopening. would be tors timely appeal now those certified or- court did not its district abuse discretion finding delay” *9 ders. there “no reason to 914 allegations all plaintiff, accept As noted factual
appeal orders. order, true, complaint in its certification “the whether the district court and determine qui employment-based and retaliation to enough tam facts to-state claim contains ” distinct, sufficiently that claims are such its plausible that is on face.’ United relief will not permitting appeal immediate cause SNAPP, Ford Inc. v. Motor ex rel. States allowing so this piecemeal appeals” and 496, (6th 2008) Co., 532 Cir. 502 F.3d judiсial appeal go “create forward would 502). II, 501 at (quoting F.3d Bledsoe 102, R. Or- efficiencies.” See economic Thus, der, weighed PID 2195-96. Complaint C. Amended Second and did not abuse relevant considerations 3729(a)(1)(A) Claims Section determining there its discretion Lowery, 426 delay. no See for was reason 3729(a)(1)(A)of the FCA Section consider the or- F.3d at 821-22. We now or “knowingly presenting], prohibits appeal. ders certified for causing] to false or fraud presented, be payment approval.” claim 31 ulent B. Standard Review 3729(a)(1)(A). A § claim U.S.C. under de novo a “This Court reviews 3729(a)(1)(A) proof § “requires dismissal court’s district ‘pre claim or fraudulent was false claim, including dismissal failure to state government.” to- United States sented’ particularity un plead with failure Y-12, LLC, v. 525 ex rel. Marlar BWXT 9(b).” United ex rel. der States [Rule] 2008). 439, (6th plead At F.3d 445 Cir. Physicians Choice Lab. Eberhard stringent: ing stage, requirement (6th LLC, Servs., 547, Fed.Appx. 642 550 alleges a ‘complex “where a relator 2016) (quoting United ex rel. Cir. States scheme,’ in viola far-reaching fraudulent (“Bledsoe Cmty. Sys., Health Inc. Bledsoe v. 3729(a)(1), § tion оf it is insufficient 493, (6th 2007)). I"), 502 I 501 Cir. F.3d scheme; simply plead the must also [s]he “Complaints alleging FCA violations must identify representative claim that false 9(b)’s requirement comply with submitted, govern to the actually pled particularity because fraud be Chesbrough, (quoting 655 F.3d 470 ment.” defrauding the fed ‘defendants accused 510). II, 501 edose F.3d at Alterna Bl government protections have the same eral 12(b)(6) tively, may survive a Rule a claim sued in other con as defendants for fraud allegations showing motion if it includes ” A, P.C., Chesbrough texts.’ v. VP F.3d “specific personal supporting a knowledge” (6th 2011) Cir. (quoting Yuhasz v. “strong inference that a [false] claim was Wellman, Inc., Brush F.3d Prather, submitted.” (6th 2003)). Thus, Cir. relator “[w]here a allege partici Relators defendants complex far-reaching pleads a fraudu pated complex, in a nationwide scheme scheme,” provide lent she also must “ex improperly promote Abilify which caused amples specific claims false submitted govern false claims to be to the submitted pursuant government to that scheme” , long allegations ment. Thеse include a discovery proceed order con chain causal links from defendants’ United States ex rel. Prather v. scheme. Inc., of claims. duct the eventual'submission Living Cmtys., Brookdale Senior 9(b) 2016) requires adequately (quoting Bled Rule 510). II, allege start to fin “In the entire chain—from qui soe 501 F.3d at tam context, fairly false caused Court construe the show defendants ‘the must com ish—to plaint light in the most be filed. favorable *10 id, ground To cover the from one end of excep See The Prather is an standard improper this pro- rule, scheme—defendants’ tion -to-our applies only usual and if motion—to the for- alleges specific othér—claims reim- “a personal relator knowl bursement—the must edge that allege directly to billing prac relates First, tices,” specific intervening a physi- conduct. supporting “strong a inference that cian to improperly whom and Otsuka BMS a (citing claim was [false] submitted.” Id. promoted Abilify prescribed must have Chesbrough, 471). the 655 F.3d at medication an off-label use or because personal knowledge Prather's exception Next, improper of an pa- inducement. applies in limited circumstances. See Unit prescription. Finally, tient must fill the Co., ed v. Walgreen States rel. Hirt ex filling pharmacy a must submit claim to (6th 2017). F.3d Cir. In Chesb- government for on reimbursement rough, an independent radiology consul just this chain prescription. While reveals tant—alleging radiology billings he re what an vehicle the FCA is for awkward viewed were insufficient fraudulent—had schemes,1 punishing promotion off-label a personal knowledge to support the neces single adequately pled claim this nature sary that false claims inference were sub 9(b)’s satisfy would Rule allow relators mitted had no because he involvement with pleading requirement proceed to and dis- billing procedures. Chesbrough, 655 F.3d covery on the entire scheme. Likewise, Eberhard, at 471. relators
In plead order to to adequately knowledge survive defendants’ failed be motion, provide they relators a represen they “per must cause not show could hаd step billing practices tative that describes each knowledge sonal con claim Eberhard, particularity: government.” a reimburse tracts with the prescription 2016) government (citing ment to the for a 642 at 552 Fed.Appx. submitted Cir. 471-72). prescription Chesbrough, fact, tainted See Abilify. Prath 655 F.3d at er, only 838 F.3d at do not ade applied 768. Relators time this has ever quately identify representative knowledge personal exception false FCA allege knowledge pleading claim. of com requirements Relators it Prather Prather, plex promotion There, scheme self. See related F.3d Abilify, they any repre exception but provide applied do circumstances not under n , actually was,. claim that. submitted specifically sentative where em the relator was. reyiew government payment. Lacking ployed medical treatment docu claim, specific encourage allegedly the court mentation submitted to Medi 9(b) apply care—i.e., pleading allegedly “relaxed” she reviewed false that, having sug despite only standard been themselves. Id. at 768. It was gested by prior opinions, this knowledge billing had been “detailed applied by very recently. this court until treatment documentation related to the opinion prescription 1. A recent from Second which the filled will be Circuit wheth- application FCA's described the awkward er the use is or off. We do not on-label promotion off-label ground, schemes well: but are decide case we assumption any dubious of just [relatoras is [I]t unclear whom Pfizer could participants one of have these relevant caused a "false or the' submit fraudu- impli- permitted knowingly, lent” have physician claim: The transactions would edly any prescriptions; patient prescription Lipi- issue off-label certified that fol- use', advice, physician’s likely lows the tor was for does an on-label off-label; Inc., Polansky Pfizer, not know whether the use is United States ex rel. (2d 2016). script pharmacy does inform the 619-20 *11 3719(a)(1)(B) requires for final requests payment, of Section submission “рlead a to a connection between specific allegations her re relator combined with alleged an actual claim made anticipated pay fraud and garding requests Chesbrough, 9(b) government.” 655 F.3d that a stan ments” satisfied relaxed must at 473. The connection be dard. Id. at 770. Engine Co. v. ex evident. See Allison U.S. Sanders, 662, 671-72, rel. Here, allege not 553 U.S. 128 relators do 2123, 170 (2008). knowledge. S.Ct. 1030 Other type personal Relators L.Ed.2d wise, and, “a cause action under the FCA representatives BMS were sales Prather, at private not fraud directed entities would the relator did di unlike to into all- threaten transform the FCA an claims rectly engage whatsoever. purpose antifraud statute.” Id. at 128 the Prather exception apply, to it order Thus, although allege 2123. relators S.Ct. enough allege personal knowledge to made false or defendants fraudulent state scheme; allegedly a of an fraudulent rela ments order increase the number allege adequate personal tor must knowl allega no Ability prescriptions, there are Id. at billing practices edge themselves. connecting any tions these statements Thus, fail to do so. absent a 768. Relators government. claim made to the Such state from representative false claim derived ments, false, rely if on a “link be even scheme, alleged promotional the second tween the false statement and Govern adequately amended fails pay approve ment’s or a false decision plead violation 31 U.S.C. claim is too attenuated to establish [that] 3729(a)(1)(A). § Thus, Id. relators fail to ade liability.” Accordingly, have to ade- relators failed 3729(a)(1)(B) § quately plead a U.S.C. quately allege a violation of 31 U.S.C. they rely on claim because a too-attenuat 3729(a)(1)(A) § in their second amended connecting alleged chain false state ed complaint. of claims. See ments to the submission
Chesbrough,
In addition to their claims
dants
received
under
3729(a)(1)(A),
§
those
allege
government
relators
vio-
and failed to refund
U.S.C.
3729(a)(1)(G);
See 31 U.S.C.
§
payments.
lations of three other sections of the FCA.
Prather,
3729(a)(1)(B) imposes liability
Alternatively,
on
at
Section
838 F.3d
makes, uses,
3729(a)(1)(G)
out
“knowingly
one who
or causes
violation is made
section
“
used,
pleads adequate
‘proof
or
or
if
that
be made
false record
the relator
material
to a false or fraudulent
made a false record or state
statement
defendant
3729(a)(1)(G)
claim.”
liabil-
that
imposes
Section
ment
time
the defendant owed
obligation’—a duty
an
ity
accepts overpayment
government
on one who
from the
Chesbrough,
money
government
pay
property.”
and fails to
refund
Am. Textile
(quoting
overpayment—a
so-called “reverse false
Mfrs.
Inst.,
Ltd., Inc.,
Inc.
3729(a)(1)(C)
v. The
liabil-
imposes
claim.” Section
1999));
ity
anyone
“conspires
to commit a
31 U.S.C.
who
3729(a)(3).
§
prohibitions.
The
court held rela-
violation”
the FCA’s other
district
adequately plead
district
relators’
tors
a reverse
dismissed
failed
relating
to all three.
false claim.
agree.
plead
Relators do not
consequence
We
foreseeable
does
sub-
facts that
received over
agreement.
show defendants
sume the aim of the
In other
they
words,
it.
payment, much less that
retained
to adequately allege an FCA con-
Moreover,
provide
no facts show
spiracy,
enough
it is not
for relators to
ing
an affirmative
defendants were under
agreement
show there
anwas
it
made
obligation
government
at the
time
likely there would
abe
violation of the
*12
alleged
the
false statements were
31
made.
FCA; they
agreement
must
an
show
was
3729(a)(3);
§
U.S.C.
see Am. Textile
made in
to violate the
order
FCA. See
Mfrs.
Inst.,
Thus,
allega
We
dis
allegations
plan
get
there
trict court’s
of their motion to
a
show
denial
file
paid.
alleged plan
complaint. Although
false
The
was to
third amended
court
Ability prescriptions through
freely give
increase
im
leave to
a com
should
amend
proper promotion.
may
plaint
justice
requires,
con
it
While this
be
when
so
does
demnable,
give
doing
it
if
so
conspir
does
amount
need
leave
would be
futile,
acy to
if it was
com
violate the FCA. Even
such as when
amended
plaint
foreseeable that
the line
cannot
a motion to
somewhere down
survive
dismiss.
Check,
Del.,
prescriptions
Ability
off-label
would be SFS
LLC v. First Bank
774
(6th
2014).
government
payment,
partial
F.3d
Cir.
After
submitted
com
Care Act. Pub.
and Affordable
ly dismissing the seeond
Protection
amended
(cid:127)
111-148,124
(2010).
L.
What
granted
Stat.
con
plaint, the district
“origi
“public
an
disclosure”
leave
file.a Rule 15 motion
amend
stitutes
changed
the FCA amend
so.2 nal
provided a
source”
deadline which-to.do
motion,
ment,
remains;
principle
common
attaching
timely
Relators
filed
but
enough in
public
occurs
complaint.
district
disclosure
“when
amended
third
futility
public
exists in
motion for
formation
domain
court denied relators’
t
12(b)(6)
See
expose
it
not survive a
the fraudulen
because
could
transaction.”
Antoon,
A
614-15.
rela-
order
Because
motion
dismiss.
district court’s
F.3d
15(a)
complaint alleges
motion
is
denying
spanning
Rule.
to amend
tors’
fraud
from 2005 to
typically
abuse
discretion.
reviewed
amended
Cо.,
subject
public-
both versions
Rose
Underwriters Ins.
v. Hartford
2000).
However,
(holding
bar. See id. at 614-15
disclosure
*13
public
in
the
court denies leave
that the
disclosure bar
ef
where
district
FCA
amended,
fraud,
complaint,
alleged
the
because the
as
fect
the time of
not
amend
But,
dismiss,
filing,
con
applies).
the
motion to
time of
would
withstand a
any
parties,
that
is
novo. Seaton v.
both
difference in
reviewed
ceded
denial
de
(6th
LLC,
592,
statutory
is
TripAdvisor
language,
F.3d
596
irrelevant if the out
728
2013). Thus,
come
the same under either
Cir.
we review the
be
ver
district
would
Lockey
City
rel.
v.
court’s order de
sion. See U.S. ex
novo.
of
(5th
431,
Dallas,
437-38
Fed.Appx.
576
1.
Bar
Public-Disclosure
2014) (“While
language
the
in
Cir.
the
from
version of the
differs
[FCA]
current
Generally,
the
unless
relator
of
prior
in
[that]
the
version
the statute
“original
an
source”
the mean
within
was
,,,
case,
the outcome
the
of this
facts
statute,
the
ing
the
FCA bars a claim
same.”). Here,
is
is
the outcome
the
the
publicly
based on
disclosed information.
versions
the
same under
statute.
ex
v.
U.S.
rel. Antoon
Cleveland Clinic
both
(6th
Found.,
2015);
F.3d
614
Cir.
788
has
To
whether a claim-
decide
3730(e)(4)(A)-(B) (2012).
§
The
U.S.C.
disclosed,
publicly
look
courts
at the
been
court determined that several
district
elements
de
essential
fraud
allegations
the new facts and
included
enough
if
exists
the
termine
information
complaint ran
the
amended
afoul
third
to expose the
public domain
fraudulent
bar,
public-disclosure
undermining
the
the
Dingle
Corp.,
Bioport
See
v.
transaction.
viability
challenge
of the
Relators
claims.
(6th
2004); Antoon,
Cir.
on appeal.
conclusion
that
Thus,
public disclo
at 614-15.
F.3d
23, 2010,
if
implicated—even
bar
one
public- sure
is
On March
by the Patient
a
elements are
bar was amended
more of
claim’s essential
disclosure
challenge
particular
complaint's
in adver
parties
deficiencies as identified
do not
this
that,
order,
in these
but we note
or
and the
court's
sarial
district
.circum
pleadings
stances,
was under no obli
the ’district court
on a
the initial order turned
der—even where
gation
grant
leave to file a Rule 15
9(b)’s
relators
particularity
meet
re
failure to
,
amеnd,
parties
fully
motion to
Where
have
SNAPP, Inc.,
quirements.
532 F.3d at
See
12(b)(6)
argued
merits of a
motion to
(noting
II
"Bledsoe
not be
510-11
that
should
duly consid
dismiss and the
court has
district
the district court must
imply
taken
arguments
opinion
those
and issued an
ered
grant
file
amended com
leave to
an
Relator
.motion,
resolving
say
stretch to
it
X,
(Suhrheinrich,
concurring).
plaint”)
justice
granting
requires
to cure the
leave
R.
public
exposed
promotion
ele
scheme.
Dist. Ct.
domain—unless
ment
ments,
However,
together, provide
Order,
it
adequate
taken
PID
was error
has been
fraudulent
notice
there
the court
hold that this resemblance
212;
Dingle,
F.3d
transaction. See
public
alone
for dismissal under
called
Medtronic, Inc.,
U.S. ex rel. Poteet
bar.
disclosure
2009)
503, 512-13
(holding
If a
pro
fraudulent off-label
public
federal claim
disclosure barred
publicly
motion scheme was
disclosed and
alleged substantially the same conduct
resolved, allegations
improper pro
then
action).-
civil
previously
as a
filed state
place
agree
that took
motion
before
transaction under
Exposing fraudulent
putatively
ments
ended the scheme would
requires
an
off-label
scheme
promotion
necessarily implicate
public
disclosure
string together
several neces-
relator
allegations
bar. But
that the scheme either
Here,
must connect
sary
elements.
agreements
despite
continued
or was
promotion
Abilify
defendants’
agreements
after the
are
restarted
differ
of a
claim to
eventual submission
related
govern
ent. It
be
that the
cannot
assumed
government.
it is
first
But
link
ment is aware a
contin
fraudulent scheme
promotion
improper
the chain—the
(or
restarted) simply
ues
was
it
because
crijcial.
because,
drug—that is
This is
even
uncovered,
resolved,
had
and then
a simi
public-
if
other
the scheme’s
elements were
Indeed,
logi
lar scheme
the most
before.4
disclosed—e.g.,
publicly
it
ly
disclosed
*14
cal
to draw from defendants’
inference
for
government
paid
the
had
claims
that
agreements
improper promotion
to cease
Abilify—the
prescriptions
FCA
off-label
Thus,
Abilify
they
is that
had
so.
to
done
if
implicated only
is
that
is some-
conduct
the extent
that relators are’ able to de
improper promotion.3,
back to
how tied
particularity
scribe with
post-agreement,
Thus,
publicly
no fraud was
with-
disclosed
improper promotion
Abilify, the mere
key
of this
out disclosure
element.
allegations
of those
to
resemblance
Here,
govern-
defendants assert that the
years
is not by
resolved
earlier
scheme
previous FCA
resultant
ment’s
actions and
enough
trigger
public
to
the
itself
disclo
Agreements
Corporate Integrity
constitute
sure bar.5
pro-
improper
of defendants’
disclosure
Here,
than
Abilify.
other
the fact that
the al-
motion
The district
finding
alleged
leged
agreed,
that
scheme resembled
described in
relators’
action,
“closely
pre-agree-
prior
the
scheme
the
enforcement
defendants
track[s]”
again, just
porate Integrity Agreements
unlikely,
Highlighting, once
how
was
3.
awkward
but
pharmaceutical
punish
allegations
it is to use the FCA
relators’
fraud continued
pre
companies
improper promotion of
for
years
agreements
intentionally for
after the
Polansky,
scription medication. See
goes
beyond any
into
well
were entered
rea
at 615.
period
government may
sonable
have ex
pected it to.
may
only
This
be
that the
4.
true
extent
allegations
temporally
from
new
are
distant
9(b)’s particularity
5.We
note that Rule
re
previously resolved
See U.S. ex
conduct.
quirements prevent
proceeding
a relator from
r
Corp.,
Keste
rel.
Pharm.
Novartis
allegations
discovery
generally
on bare
(S.D.N.Y. 2014) ("Allega
F.Supp.3d
or
describe the same
similar conduct
tions that an extensive
scheme oc
fraudulent
prior
particularity require
FCA
The
action.
February
on
[and
resolved]
curred
was
stringent.
Chesbrough,
See
ment
F.3d at
strongly
tak
indicate
scheme is
that the
still
16”).
ing place
February
February
15 and
Here,
compliance
the Cor
instantaneous
with
alleged
allege simply
im-
but then to
not otherwise show the
scheme
detail
do
,..
requesting illegal pay-
that claims
proper
publicly
was
disclosed.
promotion
submitted,
Thus,
ments must have been
were
enough
not
information
there was
likely
submitted
should have been sub-
expose
alleged
public
in the
domain
”)
transactions,
(quoting
mitted to the Government.’
meaning
pub-
fraudulent
Co.,
v. HCA-The Healthcare
Sanderson
implicate
not
lic
bar does
fraud
disclosure
2006)).
873, 877
447 F.3d
improper
to post-agreement
connected
many
third amended
identifies
promotion Abilify.
All
inadequate
claims.
inference-based
are
Representative
Un-
False Claims
pleading
under our FCA
standard.
3729(a)(1)(A)
der Section
identify
rep
Relators’ failure to
discussed,
the nar-
previously
As
outside
adequate specificity
resentative claim with
Prather,
row circumstances described
one,
examples.
For
warrants
few
relators
9(b)
requires
provide
relators
facts
identifying
attach an exhibit
reimburse
claim that
identifying representative
prescriptions
Abilify paid
for
ment
i.e.,
government,
рresented
“[t]he
pharmacies by
various
Massachusetts
of a
specific request
submission
actual
Abilify
prescriptions
Medicaid
filled
government.”
anticipated payment
pediatric patients
drug
before the
had
Prather,
at 768-69. Because rela-
However,
any
nothing
pediatric indication.
sup-
allege personal knowledge
tors
do
any
prescribing physicians,
connects
strong
porting the
inference that
facility,
name or
identified
care
such that the Prather ex-
were submitted
improper promotion. Similarly,
defendants’
they
ception
apply,
provide
could
must
identifying
an
Abili
attach
exhibit
specific representative
court with a
claim fy prescriptions paid by California Medi
government pursuant
submitted
prescribed by
physicians
two
Cal as
scheme. See id. at 768.
whom the defendants allegedly had a rela
same,
tionship.
patient diag
All the
*15
context,
representative
this
a
In
identified;
by
doctors
noses
these'
are not
of a request
prescrip
claim consists
for a
meaning
necessary
it is not a
inference
gov
tion reimbursement submitted to the
any
Abilify prescriptions
that
one of the
prescription
ernment for
an
either
off-label
for
they wrote was
an off-label More
use.
by
of
one
written
Abilify or
induced and
a
over,
nothing
alleged
there is
about the
specific provider to whom either or both
relationship
physicians
between these
promoted
drug.
improperly
defendants
the
that
the
can be characterized
defendants
end,
identify
To
rep
that
relators must
a
a violation of the Anti-Kickback Statute
as
specificity
claim
resentative
as
particular Abilify
that any
prescription
or
necessary component
each
they
improperly
wrote was
induced. The
scheme;
identifying
merely
a claim that
Abilify prescrip
same failures undercut
infers
or
of
one more
these elements is
paid Kentucky
by
tions
Medicaid.
Yuhasz,
inadequate. See
921
diagnostic
physician
working
a
assess-
a
who was
a provider
relators attach
2013
as
D.M., reporting
taking
facility
that he was
ment
a
which
allegedly
defendants
by
Ability
prescribed
promoted Ability
Thus,
another doctor
from 2005 to 2007.
July
prescriptions
Both
year.
of that
were
complaint
relies
to bridge
inference
uses,
is an
for off-label
but neither
ade-
gap
approximately eight years
a
be-
quately
representative claim.
pled
alleged promotion
tween the
in 2007 and
prescription.
D.M.’s 2015
hardly
This
satis-
First,
complaint
adequately
fails to
Twombly
Twombly,
fies the
standard. See
allege
prescription
pre
2013
was
that the
short,
U.S.
In
S.Ct. 1955.
for
government
payment.
sented
prescriptions
the D.M.
are
adequately
identity
pharma
a
complaint
does
pled representative claims.
cy
entity
may
that
any
have sub
other
claim for reimbursement
to a
mitted a
many
There are
other claims identified
government program
pre
for the 2013
similarly
are
which
inade-
However,
that,
scription.
allege
provide
quate
single,
specific claim
because D.M. had been Medicaid benefi
for
required
reimbursement
survive
life,”
dismiss;
all of his
ciary
nearly
pre
“for
motion to
We will not belabor the
by
scription was reimbursed
Ohio Medic point by individually discussing the inade-
¶
82-1,
Complt.,
aid. R.
Third Amd.
(there
quacies of each claim
many),
are
but
any
support
But absent
factual
this
say
suffice it to
that relators have not
lacking any
in
allegation
identifying
single request
prescription
identified
may
on who
formation
have submitted a
govern-
reimbursement submitted
pre
government
claim the
the 2013
Ability
ment for a
prescription
written
simply
not to
assume a
scription, we are
provider
to whom either or both
government
claim
presented
improperly promoted
drug.
defendants
say
because relators
so. See
adequate-
Relators have therefore failed to
Ashcroft
678-79,
Iqbal, 556 U.S.
S.Ct.
ly plead a
violation
31 U.S.C.
(2009); Prather,
evant (G) 3729(a)(1)(B), (C), and nothing prescription—though to fill that confirms even additional detail neither claims, Relators’ three related under (or any nor denies Ohio Medicaid *16 3729(a)(1)(B), (C), (G), § would U.S.C. government program) presented other was to likewise not survive a motion dismiss. prescription a In reimbursement. inadequacy the of Relators nowhere cure sum, any support allegation for the absent as to the section pleadings their prescription that the 2013 was submitted 3729(a)(1)(C) in conspiracy claim. As the government program any to a or more comрlaint, is no there second amendment claim, specificity repre it as to that is not paid alleged get to false claim plan a alleged sentative of the scheme. no more than allegations the remain
Second,
recitations of the elements
prescription
the 2015
fails
threadbare
Twombly,
550 U.S.
at
link in
chain the cause
action. See
an earlier
the scheme’s
Accordingly, as
to
prohibited after exer proceedings MAND for consistent cise, further government Am. Tex discretion.” opinion. with this The Inst., tile at 741. dis Mfrs. Corporate Integrity trict found STRANCH, Judge, JANE B. Circuit “contingent obligations” to be
Agreements concurring part dissenting: part. claim. trigger a reverse false and failed agree. Both We defendants were IN CONCURRING PART AND subject nearly Corporate In identical IN PART DISSENTING tegrity Agreements, the breach of which “may’’ obligations to pay stipu system, have American led health card CIA, 82-2, case, penalties. R. PID only BMS context for this is not a life and lated 1758; CIA, 82-3, industry, R. PID 1825. Otsuka Yet death also the source of one but jobs agree every eight* an these even breach of the United States itself, not, by an every gross did constitute and one dollar of six in our ments obli gation pay This be government. product. Employment domestic See Ma for, Sector, jor Industry a breach of the Labor Sta causе Bureau penalties (Dec. 2015), subject to.discretionary agreements were tistics "https://www.bls.gov/ *17 by Inspector emp/ep_table_201.htm; the Office the Health enforcement National General, 2016-2025, Expenditure Projections Ctrs. who whether determine 1, penalties “appropriate” the were & Medicare Servs. before Medicaid triggering review.pro an administrative https://www.cms.gov/Research-Statistics- 82-2, to collect penalties. Dataand-Systems/Statistics-Trends-and- cess those R . CIA, 82-3, 1760-61; Reports/NationalHealthExpendData/ PID BMS R. Otsuka
923 (last (2010) (citations Downloads/proj2016.pdf visited 225 Oct. L.Ed.2d and internal marks, 2017). 20, scale of health care omitted), The fraud is quotation then and ex I comparably huge. previously As have panded again 2009, scope its in Boegh v. discussed, rampant health care in fraud EnergySolutions, Inc., 1056, 1062 likely the costs United States Medicare (6th 2014). amendments, Cir. In the 2009 and between and billion Medicaid $30 $98 Congress recognized important role year. rel. Doghramji each United States ex relators, qui explained tarn that the “effec Inc., Cmty. Sys., 666 Fed.Appx. Health tiveness the False Claims Act ha[d] 2016) 410, (Stranch, J., 419 con recently been by undermined court deci curring). That cost is transferred us all law,” scope sions which limit the and bills, in higher the forms of health care protections expanded FCA for' relators. S. premiums, co-pays, taxes. The and False 111-10, (2009). Rep. No. at 4 This case (FCA), legal Act vehicle that Claims in arises context of that Congressional bring identifying relators use to and is post- concern and reviewed under the fraud, combatting operates on the provisions of 2009 the FCA. scale, having same massive allowed the respectfully I majority United States over dissent from the recover billion $31 2009 2016. See De opinion except public-disclosure between and Justice its bar partment 11(D)(1). Recovers Over From analysis Billion in Part $4.7 I concur in the Claims Act False Fiscal Year Cases holding public-disclosure that the bar does (Dec. 2016, 14, 2016), Dep’t U.S. Justice apply con- fraudulent schemes that https://www.justice.gov/opa/pr/justice- or are following tinue restarted a defen- department-recovers-over-47-billion-false- entry agreement into an with the dant’s claimsact-cases-fiscal-year-2016. Maj. A government. Op. at- 917-20. con- trary rule company would-allow use
Qui tarn relators are critical agreements disclosed lia- operation. responsi publicly FCA’s Their suits are avoid sixty-three percent bility previ- ble for over of FCA for future bad that mirror acts 1986 Do recoveries between and 2008. today, misdeeds. The announced ous rule (Stranch, 419 ghramji, Fed.Appx. hand, 666 the public- the other ensures that on J., FCA, concurring). drafting When chal- prohibit bar does not disclosure “Congress expansively* meaning ‘to wrote improper lenge post-agreement behav- fraud, types qualifica all reach without my I turn to the reasons for ior. dissent. tion, might in financial loss to result ” relators-allege the defendants The County Government.’ Cook v. United again submitting FCA once violated 119, 129, Chandler, States ex rel. 538 U.S. of millions dollars of claims hundreds 1239, (2003) 155 S.Ct. L.Ed.2d 247 123 promoted illegally an prescriptions (quoting United States v. Neifert-White drug. complaint alleges facts on based 228, Co., 232, 19 U.S. S.Ct. personal 'knowledge, collabo (1968)). Congress has relators’ L.Ed.2d others, research. ration extensive expansive position. backed from this down stage proceedings, “the At Congress To the amended contrary, in .the complaint must construe the Court strengthen Act “to the Govern plaintiff, accept claims, most light favorable fighting hand ment’s false true, allegations factual deter all encourage private more enforcement suits,” contains Cty. Soil & mine whether Graham Water Conser enough facts to state a claim relief that Dist. v. United States ex rel. Wil vation son, 280, ex plausible 559 U.S. its face.” United States S.Ct. *18 924 Living pleading v. a strict stan applying
rel. Prather
Brookdale Senior
When
Prather,
(6th
Inc.,
750,
prior
in eases
we left
Cir. dard
Cmtys.,
838 F.3d
761
possibility that a
can sur
2016)
open the
relator
rel.
(quoting United States
ex
vive a motion to dismiss when the relator
SNAPP,
Co.,
v. Ford Motor
532 F.3d
Inc.
strong
pled
support
“has
facts which
a
2008)).
496,
(6th
502
Cir.
that a claim was
inference
submitted.”
fraud,
sounding
brought
in
When
Prather,
(quoting
838
at 769
Chesb
F.3d
9(b)’s
satisfy
must
under the FCA
A,
461,
(6th
P.C., 655 F.3d
rоugh v. VP
471
that the
fraudulent
requirement
relevant
2011)); see also United States ex rel.
Cir.
particulari
circumstances be stated “with
Network,
Kettering
v.
Sheldon
Health
816
9(b);
ty.”
P.
see
Fed. R. Civ.
also United
(6th
2016).
399,
Prather,
414
In
F.3d
Cir.
Cmty.
ex
v.
Health
States
rel. Bledsoe
every
ap
that
circuit that has
we noted
(6th
Inc.,
493, 504
Sys.,
501 F.3d
Cir. plied
heightened pleading
a
standard “has
2007).
pleading in this con
Particularized
requirement
from such a
in
retreated
requires
showing of
typically
a
a false
text
in which
cases
other
factual alle
detailed
actually
claim
that was
submitted
strong
that
gations support a
inference
Bledsoe,
(“A
government.
501
at 505
F.3d
Prather,
claims were
838 F.3d
submitted.”
[pleading]
meet
relator cannot
stan
917-18;
Thayer,
(citing
at 772
765 F.3d
alleging
specific
dard without
which
false Lemmon,
1172;
614
F.3d
United States
FCA.”).
claims constitute
violation
Props.
Cty.,
ex
v. R&F
Lake
rel. Walker
But,
concluded,
our sister circuits have
as
1349,
(11th
2005)).
Inc.,
F.3d
1360
Cir.
433
particularity
necessarily synonymous
is not
adoption
our
of that
“confirmed]
We then
representative samples. Particularity
holding
exception,”
plaintiff
that
can
may
a rеlator “al-
also be satisfied where
by pleading
“survive a motion to dismiss
of a
leg[es] particular details
scheme
specific
personal billing-
facts
based
her
claims paired
submit false
with reliable
support
strong
knowledge
related
a strong
specific
inference that
indicia that lead
inference that
false claims were
actually
payment.”
claims were
submitted.” United
925
er, Inc.,
(1st
specific
2007)).
January
2008 at
CVS
733
paid by
employed
bill
pharmacy;
the
was
These relators
this
method
$370.59
off-
The use was
Massachusetts Medicaid.
support
examples
the
of false claims de-
because,
time, Abilify
at the
had not
foremost,
label
First
scribed above.
and
the re-
patients
for
un-
medically
been
indicated
personal knowledge
lators have
of
cor-
the
As
age
the
of thirteen.
another exam-
der
strategies employed
porate
promote
off-
ple, April
personal-
in
relator Ibanez
Abilify. They
provide
label uses
also
ly
meeting discussing
in on a
sat
hоw
extensive statistical evidence that creates
Abilify
to a
promote
specif-
off-label use
strong
the
inference both that this scheme
in
psychiatrist
ic child
adolescent
Cin-
and
and that it
in
occurred
substantial
resulted
124
just
That doctor had
written
cinnati.
paid by
government.
claims
the
Abilify
prescriptions
had been
majority opinion points
The
out that the
filled between November
and Janu-
in
complaint
facts
are not
identical
ary
paid
by Kentucky
Medic-
and
Prather,
in
those
where
relator alleged
the
majority opinion,
in
aid. As discussed
the
“specific personal knowledge that relates
(cid:127)prescriptions
for off-label use
Abilify
directly
billing practices.”
Maj. Op. at
juvenile
paid
written for
D.M.
were
and
Prather,
769).
I
(quoting
838 F.3d at
by
Maj. Op. at 920-21. The
Ohio Medicaid.
agree that the
this case were
of in-
majority is
the lack
concerned with
personally
billing.
not
involved
Howev-
formation about D.M.’s
Medicaid
receipt
er,
the relators here have nonetheless
gap
pro-
reimbursements and the
between
“pled
support
strong
facts which
infer-
filling
prescription.
motion
the
Id. But
and
Prather,
ence that a
claim
submitted.”
complaint explains
the
that relator Ibanez
(quoting Chesbrough,
fore KERR, Hope KERR, for Hank W. Deceased, Plaintiff-Appellant, OF SOCIAL COMMISSIONER SECURITY, Defendant-
Appellee. No. 16-6673 Appeals, United States Court Sixth Circuit. Argued: June 1, 2017 Decided and Filed: November