us ex rel. ge v. takeda pharmaceutical company, 1st cir. (2013)

7/26/2019 US ex rel. Ge v. Takeda Pharmaceutical Company, 1st Cir. (2013)

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United States Court of AppealsFor the First Circuit

No. 13- 1088

UNI TED STATES ex r el . HELEN GE, M. D. ,

Rel at or , Appel l ant ,

STATE OF CALI FORNI A; STATE OF DELAWARE; STATE OF FLORI DA;STATE OF GEORGI A; STATE OF HAWAI I ; STATE OF I LLI NOI S; STATE OF

LOUI SI ANA; STATE OF I NDI ANA; STATE OF MI CHI GAN; STATE OFMI NNESOTA; STATE OF MONTANA; STATE OF NEVADA; STATE OF NEW

HAMPSHI RE; STATE OF NEW J ERSEY; STATE OF NEW MEXI CO; STATE OF NEWYORK; STATE OF NORTH CAROLI NA; STATE OF OKLAHOMA; STATE OF RHODE

I SLAND; STATE OF TENNESSEE; STATE OF TEXAS; STATE OF WI SCONSI N;COMMONWEALTH OF MASSACHUSETTS; COMMONWEALTH OF VI RGI NI A;

DI STRI CT OF COLUMBI A,

Pl ai nt i f f s,

v.

TAKEDA PHARMACEUTI CAL COMPANY LI MI TED;TAKEDA PHARMACEUTI CAL NORTH AMERI CA, I NC. ,

Def endant s, Appel l ees.

No. 13- 1089

UNI TED STATES ex r el . HELEN GE, M. D. ,

Rel at or , Appel l ant ,

STATE OF CALI FORNI A; STATE OF DELAWARE; STATE OF FLORI DA; STATEOF GEORGI A; STATE OF HAWAI I ; STATE OF I LLI NOI S; STATE OFLOUI SI ANA; STATE OF I NDI ANA; STATE OF MI NNESOTA; STATE OF

MONTANA; STATE OF NEVADA; STATE OF NEW HAMPSHI RE; STATE OF NEWJ ERSEY; STATE OF NEW MEXI CO; STATE OF NEW YORK; STATE OF NORTHCAROLI NA; STATE OF OKLAHOMA; STATE OF RHODE I SLAND; STATE OF

TENNESSEE; STATE OF TEXAS; STATE OF WI SCONSI N; COMMONWEALTH OFMASSACHUSETTS; COMMONWEALTH OF VI RGI NI A; DI STRI CT OF COLUMBI A,

Pl ai nt i f f s,

v.


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TAKEDA PHARMACEUTI CAL COMPANY LI MI TED;TAKEDA PHARMACEUTI CAL NORTH AMERI CA, I NC. ,

Def endant s, Appel l ees.

APPEALS FROM THE UNI TED STATES DI STRI CT COURTFOR THE DI STRI CT OF MASSACHUSETTS

[ Hon. F. Denni s Sayl or I V, U. S. Di st r i ct J udge]

Bef or e

Lynch, Chi ef J udge,St ahl and Howar d, Ci r cui t J udges.

Mi chael Sul l i van, wi t h whom The Ashcr of t Gr oup, Mi chael L.Baum, Bi j an Esf andi ar i , R. Br ent Wi sner , and Baum, Hedl und, Ar i st ei& Gol dman, P. C. wer e on br i ef , f or appel l ant .

Br i an J . Mur r ay, wi t h whomMorgan R. Hi r st , Mar r on A. Mahoney,Chr i st opher M. Mor r i son, J oseph B. Sconyer s, and J ones Day wer e onbr i ef , f or appel l ees.

Mel i ssa N. Pat t er son, At t or ney, Appel l at e St af f , Ci vi lDi vi si on, wi t h whom St uar t F. Del er y, Act i ng Assi st ant At t or neyGener al , Car men M. Or t i z, Uni t ed St at es At t or ney, and Mi chael S.Rabb, At t or ney, Appel l at e St af f , Ci vi l Di vi si on, wer e on br i ef , f ort he Uni t ed St at es of Amer i ca as Ami cus Cur i ae.

December 6, 2013


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LYNCH, Chief Judge. I n J une 2010 Dr . Hel en Ge or i gi nal l y

f i l ed t hese t wo qui t amact i ons agai nst her f or mer empl oyer , Takeda

Pharmaceut i cal Company Lt d. and i t s subsi di ary Takeda

Phar maceut i cal Nor t h Amer i ca, I nc. ( col l ect i vel y, "Takeda") , under

t he f eder al Fal se Cl ai ms Act ( "FCA") , 31 U. S. C. 3729 et seq. , and

var i ous anal ogous st at e st at ut es. The t wo act i ons concer n

di f f er ent dr ugs. She has si nce amended each of her compl ai nt s

t wi ce. The Uni t ed St at es has decl i ned t o ent er t he case as a

par t y. I n a successf ul qui t am acti on, t he r el at or col l ects a

por t i on of t he award t o t he government r egardl ess of whet her t he

gover nment i nt ervenes. See Uni t ed St ates ex r el . Duxbur y v. Or t ho

Bi ot ech Pr ods. , L. P. ( "Duxbur y I ") , 579 F. 3d 13, 16 ( 1st Ci r .

2009) .

Dr . Ge has al l eged i n her second amended compl ai nt s t hat

Takeda had f ai l ed t o di scl ose adequat el y t he r i sks associ at ed wi t h

f our of i t s dr ugs and gener al l y t hat t hi s f ai l ur e r esul t ed i n t he

submi ssi on of f al se cl ai ms by var i ous t hi r d- par t y pat i ent s and

physi ci ans f or government payment t hr ough, f or exampl e, Medi car e or

Medi cai d r ei mbur sement .

On Takeda' s mot i ons t o di smi ss, t he di st r i ct cour t

di smi ssed bot h of Dr . Ge' s act i ons under Feder al Rul e of Ci vi l

Pr ocedur e 9( b) f or f ai l ur e t o pl ead f r aud wi t h par t i cul ar i t y and,

i n addi t i on, under Feder al Rul e of Ci vi l Pr ocedur e 12( b) ( 6) f or

f ai l ur e t o st at e a cl ai m. Uni t ed St at es ex r el . Ge v. Takeda

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Phar m. Co. Lt d. , Nos. 10- 11043- FDS, 11- 10343- FDS, 2012 WL 5398564

( D. Mass. Nov. 1, 2012) . Dr . Ge proposed t o amend t he second

amended compl ai nt yet agai n, asser t i ng st i l l mor e t heor i es of FCA

l i abi l i t y. The di st r i ct cour t decl i ned t o al l ow f ur t her amendment .

Dr . Ge now appeal s, maki ng t hree l evel s of argument s:

( 1) as t o t he Rul e 9( b) di smi ssal , t hat her compl ai nt s cont ai n

suf f i ci ent al l egat i ons concer ni ng " t he who, what , wher e, and when"

of Takeda' s mi sconduct t o sat i sf y Rul e 9( b) ' s par t i cul ar i t y

r equi r ement , see Duxbur y I , 579 F. 3d at 30 ( quot i ng Rodi v. S. New

Eng. Sch. of Law, 389 F. 3d 5, 15 ( 1st Ci r . 2004) ) ( i nt er nal

quot at i on mar k omi t t ed) , ( 2) t he di st r i ct cour t abused i t s

di scr et i on i n r ej ect i ng wi t hout opi ni on t wo request s, one pr e-

j udgment and one post - j udgment , by Dr . Ge t o amend her compl ai nt s

agai n, and ( 3) as t o Rul e 12( b) ( 6) , t hat t he di st r i ct cour t ' s

anal ysi s r el i es on an over l y r est r i ct i ve concept i on of FCA

l i abi l i t y.

Thi s opi ni on concer ns t he f i r st t wo ar guments. We af f i r m

t he di st r i ct cour t on i t s Rul e 9( b) and deni al of amendment

r ul i ngs, and do not r each t he 12( b) ( 6) i ssue.

I .

I n Sept ember 2008, Dr . Ge took a posi t i on wi t h Takeda as

a cont r act physi ci an, cont r act i ng t o per f or m medi cal r evi ews of

adver se event r epor t s. Dr . Ge was r esponsi bl e f or r epor t s of

adver se event s, i ncl udi ng t hose concer ni ng f our speci f i c dr ugs f or

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speci f i c di seases: Act os ( t ype 2 di abet es) , Ul or i c ( gout ) ,

Kapi dex/ Dexi l ant ( gast r oesophageal r ef l ux di sease) , and Pr evaci d

( same) . Takeda sel l s al l f our dr ugs and each r equi r ed Food and

Dr ug Admi ni st r at i on ( "FDA") appr oval f or t hese uses. Dr . Ge' s

t asks i ncl uded ascer t ai ni ng t he ser i ousness of a repor t ed event ,

det er mi ni ng whet her t he associ ated dr ug was causal l y r esponsi bl e

f or t hat event , and det er mi ni ng whet her t hat event const i t ut ed a

"saf et y si gnal , " t hat i s whet her t he r epor t ed event si gnal ed t he

need f or addi t i onal saf et y war ni ngs. Dr . Ge wor ked f or Takeda

unt i l J anuary 2010. She asser t s that when she compl ai ned about

i mpr oper r epor t i ng at Takeda, her cont r act was summar i l y

t er mi nated.

On J une 18, 2010, Dr . Ge f i l ed an FCA compl ai nt under

seal agai nst Takeda per t ai ni ng t o Act os. Uni t ed St at es ex r el .

Hel en Ge v. Takeda Pharmaceut i cal Co. , et al , 10- 11043- FDS. On

March 1, 2011, Dr . Ge f i l ed a second compl ai nt under seal

per t ai ni ng t o Ul or i c, Kapi dex/ Dexi l ant , and Pr evaci d. Uni t ed

St at es ex r el . Hel en Ge v. Takeda Phar maceut i cal Co. , et al ,

11- 10343- FDS. I n Dr . Ge' s compl ai nt s, she al l eged on behal f of t he

Uni t ed St at es1 t hat t hr ee FCA sect i ons wer e vi ol at ed: ( a) 31 U. S. C.

1 Dr . Ge' s compl ai nt s al so br ought cl ai ms on behal f ofCal i f or ni a, Del awar e, Fl or i da, Geor gi a, Hawai i , I l l i noi s, I ndi ana,Loui si ana, Massachuset t s, Mi chi gan, Mi nnesot a, Mont ana, Nevada, NewHampshi r e, New J ersey, New Mexi co, New Yor k, Nor t h Carol i na,Okl ahoma, Rhode I sl and, Tennessee, Texas, Vi r gi ni a, Wi sconsi n, andt he Di st r i ct of Col umbi a, al l egi ng vi ol at i ons by Takeda of si mi l arst at e st at ut es. Mi chi gan i s onl y a par t y t o t he Act os appeal .

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3729( a) ( 1) ( A) , whi ch i mposes l i abi l i t y on any per son who

"knowi ngl y pr esent s, or causes t o be pr esent ed, a f al se or

f r audul ent cl ai m f or payment or appr oval , " ( b) 3729( a) ( 1) ( B) ,

whi ch i mposes l i abi l i t y on any per son who "knowi ngl y makes, uses,

or causes t o be made or used, a f al se r ecord or st atement mater i al

t o a f al se or f r audul ent cl ai m, " and ( c) 3729( a) ( 1) ( C) , whi ch

i mposes l i abi l i t y on any per son who conspi r es t o commi t a vi ol at i on

of , among ot her t hi ngs, 3729( a) ( 1) ( A) or 3729( a) ( 1) ( B) .

I n l at e 2011 and ear l y 2012, Dr . Ge f i l ed amended

compl ai nt s i n bot h cases whi l e bot h compl ai nt s wer e st i l l under

seal . Bet ween l at e Mar ch and ear l y Apr i l 2012, Dr . Ge f i l ed a

second set of amended compl ai nt s af t er t he compl ai nt s were

unseal ed. Dr . Ge' s second amended compl ai nt s are t he ones di r ect l y

at i ssue on appeal .

Dr . Ge al l eged Takeda had f ai l ed t o r epor t pr ompt l y and

accur at el y to the FDA a number of post - appr oval adver se event s

associ at ed wi t h t he f our subj ect dr ugs. The FDA i s r esponsi bl e f or

t he appr oval of dr ugs f or commer ci al market i ng. See 21 U. S. C.

355. The FDA i s aut hor i zed af t er appr oval t o cont i nue t o

eval uat e the saf et y and ef f ect i veness of t he dr ug and, wher e

appr opr i at e, t o wi t hdr aw appr oval or r equi r e a change i n l abel i ng.

See i d. 355( k) . FDA r egul at i ons r equi r e pr ompt , accur at e r epor t s

of adver se dr ug event s by dr ug manuf actur er s. 21 C. F. R. 314. 80,

314. 81. The r ecei pt of an adver se r epor t does not i n and of i t sel f

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show a causal r el at i onshi p bet ween a dr ug and t he i l l ness ment i oned

i n a r epor t . N. J . Car pent er s Pensi on & Annui t y Funds v. Bi ogen

I dec, I nc. , 537 F. 3d 35, 53 ( 1st Ci r . 2008) .

I t i s undi sput ed t hat Takeda di d submi t adver se event

r epor t s and t her e i s no speci f i c al l egat i on t hat any of t he event s

whi ch ar e t he subj ect of t he compl ai nt wer e not event ual l y r epor t ed

i n some f or mt o t he FDA. As t o t he dr ug Act os, Dr . Ge al l eged t hat

she was asked by Takeda t o mi sr epor t adver se event s i ncl udi ng

i nci dences of hear t f ai l ur e, r enal f ai l ur e, pancreat i c cancer , and,

most not abl y, bl adder cancer . Dr . Ge al l eged t hat she compl i ed

wi t h t hose di r ect i ons on cer t ai n occasi ons af t er havi ng made known

her obj ect i ons. I n addi t i on, Dr . Ge al l eged t hat she had

di scover ed syst emat i c under - r epor t i ng by Takeda of t he i nci dence of

bl adder cancer i n adver se event r epor t s.

The FDA di d r ecei ve i nf or mat i on on bl adder cancer r i sk

because i n J une 2011, t he FDA i ssued an of f i ci al war ni ng " t hat use

of t he di abet es medi cat i on Act os ( pi ogl i t azone) f or mor e t han one

year may be associ at ed wi t h an i ncr eased r i sk of bl adder cancer . "

FDA Dr ug Saf et y Communi cat i on: Updat e t o ongoi ng saf et y r evi ew of

Act os ( pi ogl i t azone) and i ncr eased r i sk of bl adder cancer ( J une 15,

2011) , ht t p: / / www. f da. gov/ Dr ugs/ Dr ugSaf ety/ ucm259150. htm. The FDA

al so mandat ed a l abel change. FDA Dr ug Saf et y Communi cat i on:

Updat ed dr ug l abel s f or pi ogl i t azone- cont ai ni ng medi ci nes ( Aug. 4,

2011) , ht t p: / / www. f da. gov/ dr ugs/ dr ugsaf et y/ ucm266555. ht m. But i t

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al so i ssued a suppl ement al appr oval of Act os af t er knowi ng of t he

bl adder cancer r i sk. Dr . Ge al l eges t hat af t er t he l abel i ng change

t he sal es of Act os pl ummet ed.

As t o t he dr ugs Ul or i c, Kapi dex/ Dexi l ant , and Pr evaci d,

Dr . Ge al l eged t hat Takeda pr essured her t o f al si f y her medi cal

concl usi ons, aski ng her t o cl assi f y event s as "non- ser i ous" or t o

change her causal i t y assessment t o "unr el at ed" so as t o avoi d

" r epor t i ng wi t hi n 15 days" as r equi r ed by FDA r egul at i on. See 21

C. F. R. 314. 80( c)( 1) ( i ) ( r equi r i ng r epor t of "ser i ous and

unexpect ed" adver se event wi t hi n 15 days) . Speci f i cal l y, Dr . Ge

al l eged t hat she was di r ect ed t o al t er her anal ysi s of r epor t ed

adver se event s i nvol vi ng t he i nt er act i ons bet ween the thr ee dr ugs

and ot her medi cat i ons l i kel y t o be t aken by seni or ci t i zens. Dr .

Ge di d not cl ear l y al l ege t hat she compl i ed wi t h Takeda' s

di r ect i ons. Dr . Ge di d al l ege, however , t hat on var i ous occasi ons

Takeda of f i ci al s al t er ed her assessments di r ect l y.

As t o Ul or i c, at some poi nt Takeda submi t t ed a

Suppl ement al New Dr ug Appl i cat i on t o updat e t he Adver se React i ons

sect i on of t he Ul or i c l abel . The FDA appr oved t hi s suppl ement al

appl i cat i on on J anuar y 28, 2011. 2

2 At t i mes Dr . Ge' s compl ai nt appear s t o be di r ect ed agai nstt he FDA f or i t s f ai l ur e t o r equi r e gr eat er war ni ngs on l abel s, suchas f or Pr evaci d.

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As t o al l f our dr ugs Dr . Ge asser t s t hat Takeda shoul d

have r epor t ed adver se event s ear l i er , and t hat Takeda consi st ent l y

t ook act i ons t o r esi st l abel changes t hr ough under - r epor t i ng.

On May 11, 2012, Takeda f i l ed i t s mot i on t o di smi ss. Dr .

Ge f i l ed a memorandum i n opposi t i on on J ul y 17, 2012. At t he end

of her memor andum but not as a separat e mot i on, Dr . Ge r equest ed

l eave t o amend her compl ai nt s a t hi r d t i me, i f t he cour t was

i ncl i ned t o di smi ss, and suppor t ed i t wi t h a decl ar at i on f r om one

of her at t or neys t hat i ncl uded an at t achment pr ovi di ng t he t ot al

expendi t ures by t he f ederal government f or Act os. On August 27,

2012, Takeda f i l ed a mot i on t o st r i ke t hat decl ar at i on.

On November 1, 2012, t he di st r i ct cour t di smi ssed i n a

wr i t t en or der Dr . Ge' s cl ai ms under Rul e 9( b) , r easoni ng t hat

"al t hough r el at or has al l eged f act s t hat woul d demonst r at e a

' f r aud- on- t he- FDA' wi t h r espect t o i nt ent i onal under - r epor t i ng of

adver se event s, she has f ai l ed t o al l ege t he speci f i c det ai l s of

any cl ai ms t hat wer e al l egedl y r ender ed ' f al se' as a r esul t . "

Takeda, 2012 WL 5398564, at *4. The di st r i ct cour t not ed t hat Dr .

Ge had at t empt ed t o cur e t hi s def ect by r ef er r i ng t o her at t or ney' s

decl ar at i on, whi ch at t ached t he t ot al aggr egat e expendi t ur e dat a by

t he gover nment f or Act os. I d. The di st r i ct cour t hel d, however ,

t hat even assumi ng i t was per mi ssi bl e f or t he cour t t o consi der t he

Act os dat a, such aggr egat e expendi t ur e data di d not sat i sf y Rul e

9( b) ' s par t i cul ar i t y r equi r ement . I d. The di st r i ct cour t

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cont r ast ed Dr . Ge' s pl eadi ngs wi t h t he pl eadi ngs of t he r el at or i n

Duxbur y I , whi ch i dent i f i ed ei ght speci f i c medi cal pr ovi der s who

al l egedl y submi t t ed f al se cl ai ms, t he r ough t i me per i ods,

l ocat i ons, and amount s of t he cl ai ms, and t he speci f i c gover nment

pr ograms t o whi ch t he cl ai ms wer e made. Takeda, 2012 WL 5398564,

at *4 ( ci t i ng Duxbur y I , 579 F. 3d at 29- 30) .

Fr om t he absence of such speci f i cs i n Dr . Ge' s

compl ai nt s, t he di st r i ct cour t i nf er r ed t hat Dr . Ge meant t o asser t

t hat al l cl ai ms f or t he subj ect dr ugs dur i ng t he r el evant t i me

per i od wer e r ender ed f al se by Takeda' s al l eged mi sconduct . I d. at

*5. The di st r i ct cour t hel d t hat Dr . Ge had not pr ovi ded t he

speci f i c f act ual al l egat i ons necessar y t o suppor t t he i nf er ence

t hat t he FDA woul d have wi t hdr awn appr oval f r om al l f our dr ugs

i mmedi at el y upon r ecei vi ng t he wi t hhel d i nf or mat i on. I d. ; see al so

21 C. F. R. 314. 80( j ) , 314. 81( d) ( "I f an appl i cant f ai l s t o

est abl i sh and mai nt ai n r ecords and make r epor t s r equi r ed under t hi s

sect i on, FDA may wi t hdr aw appr oval of t he appl i cat i on and, t hus,

pr ohi bi t cont i nued mar ket i ng of t he dr ug pr oduct t hat i s t he

subj ect of t he appl i cat i on. ") ( emphasi s added) . The di st r i ct cour t

went beyond t hat t o poi nt out t hat even wer e i t t o accept t he

unsubst ant i ated pr emi se t hat dr ugs woul d have been t aken of f t he

mar ket , t her e wer e st i l l no al l egat i ons about how t he f r audul ent

r epor t i ng woul d r ender f al se t hose cl ai ms whi ch wer e f i l ed bef or e

t he adver se event s occur r ed.

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I n t he same November 1, 2012 order , t he di st r i ct cour t

al so di smi ssed Dr . Ge' s cl ai ms under Rul e 12( b) ( 6) f or f ai l ur e t o

st at e a cl ai m, hol di ng t hat Dr . Ge had not adequatel y est abl i shed

t hat compl i ance wi t h adver se- event r epor t i ng r equi r ement s was a

"mat er i al pr econdi t i on" t o t he payment of t he cl ai ms at i ssue.

Takeda, 2012 WL 5398564, at *6; see al so Uni t ed St at es ex r el .

Hut cheson v. Bl ackst one Med. , I nc. , 647 F. 3d 377, 392 ( 1st Ci r .

2011) ( hol di ng t hat FCA l i abi l i t y exi st s wher e cl ai ms submi t t ed

"mi sr epr esent ed compl i ance wi t h a pr econdi t i on of payment so as t o

be f al se or f r audul ent " and wher e "t hose mi sr epr esent at i ons wer e

mat er i al ") . The di st r i ct cour t obser ved t hat i t i s wi t hi n t he

FDA' s di scr et i on t o r espond t o vi ol at i ons of adver se- event

r epor t i ng r equi r ement s i n a number of ways, onl y t he harshest of

whi ch i s t he wi t hdr awal of drug approval . Takeda, 2012 WL 5398564,

at *6. The di st r i ct cour t not ed i n addi t i on t hat t he FDA' s

enf or cement pr ocedur es provi de the oppor t uni t y f or ci t i zens t o

pet i t i on t he FDA t o br i ng act i on agai nst speci f i c vi ol at or s. I d.

( ci t i ng 21 C. F. R. 10. 30) . The di st r i ct cour t r easoned t hat "[ i ] t

i s t hr ough t hat mechani sm, r at her t han an FCA l awsui t , t hat r el at or

shoul d have br ought t he r epor t i ng i ssues i l l umi nat ed i n t he

compl ai nt s t o t he at t ent i on of t he FDA. " I d.

Fi nal l y, t he di st r i ct cour t di smi ssed i n t hat same or der

Dr . Ge' s var i ous st at e- l aw cl ai ms bot h because t hey f ai l ed t o st at e

a cl ai m under st at e l aw and because t hey f ai l ed t o pl ead wi t h

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speci f i ci t y t he det ai l s of any cl ai ms f or payment made t o any of

t he st at es. I d. The di st r i ct cour t di d not addr ess Dr . Ge' s

r equest f or l eave t o amend. J udgment was ent ered f or def endant s on

November 1, 2012.

On November 29, 2012, Dr . Ge f i l ed a f ormal mot i on f or

r econsi der at i on pur suant t o Rul e 59( e) al ong wi t h a mot i on f or

l eave t o amend her compl ai nt . Dr . Ge' s mot i ons were suppor t ed by

( a) an economi c model const r uct ed by a phar maceut i cal economi cs

pr of essor f r omt he School of Phar macy at t he Uni ver si t y of Sout her n

Cal i f or ni a pur por t i ng t o show t he amount of cl ai ms f or Act os t hat

woul d not have been submi t t ed f or government payment but f or

Takeda' s al l eged mi sconduct , and ( b) t he decl ar at i ons of ei ght

i ndi vi dual s at t est i ng t hat an i ndi vi dual pat i ent woul d not have

submi t t ed hi s or her cl ai m i f Takeda had pr ompt l y and accur at el y

di scl osed t he l i nk between Act os and bl adder cancer . On December

18, 2012, t he di st r i ct cour t deni ed Dr . Ge' s mot i ons wi t hout

opi ni on. On J anuar y 14, 2013, Dr . Ge f i l ed a t i mel y not i ce of

appeal . 3

3 Appear i ng as ami cus cur i ae i n suppor t of nei t her par t y, t heUni t ed St at es makes a l i mi t ed ar gument t hat t he di st r i ct cour ter r ed i n i t s Rul e 12( b) ( 6) anal ysi s t o t he ext ent t hat i t r easoned( 1) t he avai l abi l i t y of al t er nat i ve admi ni st r at i ve r emedi es

pr ecl udes FCA l i abi l i t y, and ( 2) t he f ai l ur e t o compl y wi t h FDApost - appr oval r epor t i ng r equi r ement s i s per se i mmat er i al t o theGover nment ' s deci si on whet her t o r ei mbur se a cl ai mand hence coul dunder no ci r cumst ances ser ve as a basi s f or FCA l i abi l i t y.Accor di ng t o t he Uni t ed St at es, f ai l ur e t o compl y wi t h FDA post -appr oval r epor t i ng r equi r ement s coul d serve as a basi s f or FCAl i abi l i t y onl y i n "r ar e ci r cumst ances. " I t was obj ecti ng onl y t o

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I I .

We r evi ew de novo t he di st r i ct cour t ' s di smi ssal or der

f or f ai l ur e t o compl y wi t h Rul e 9( b) . Uni t ed St at es ex r el . Gagne

v. Ci t y of Wor cest er , 565 F. 3d 40, 45 ( 1st Ci r . 2009) . Rul e 9( b)

pr ovi des: "I n al l egi ng f r aud or mi st ake, a par t y must st at e wi t h

par t i cul ar i t y t he ci r cumst ances const i t ut i ng f r aud or mi st ake. "

Fed. R. Ci v. P. 9( b) .

The di st r i ct cour t cor r ect l y ci t ed t he r el evant pl eadi ng

r equi r ement s: Rel at or s ar e r equi r ed t o set f or t h wi t h

par t i cul ar i t y t he "' who, what , when, wher e, and how' of t he al l eged

f r aud. " Uni t ed St at es ex. r el Wal sh v. East man Kodak Co. , 98 F.

Supp. 2d 141, 147 ( D. Mass. 2000) ( quot i ng Uni t ed St ates ex r el .

Thompson v. Col umbi a/ HCA Heal t hcar e Cor p. , 125 F. 3d 899, 903 ( 5t h

Ci r . 1997) ) ; see al so Ar r uda v. Sear s, Roebuck & Co. , 310 F. 3d 13,

18- 19 ( 1st Ci r . 2002) .

As we not ed a f ew mont hs ago i n Uni t ed Stat es ex r el .

Duxbur y v. Or t hobi ot ech Pr oduct s, L. P. ( "Duxbur y I I " ) , 719 F. 3d 31,

33 ( 1st Ci r . 2013) :

"Al t hough [ t he FCA' s] f i nanci al i ncent i veencour ages woul d- be rel at or s t o expose f r aud, "Uni t ed St at es ex r el . Pot eet v. Bahl er Med. ,I nc. , 619 F. 3d 104, 107 ( 1st Ci r . 2010) , i tal so at t r act s " ' par asi t i c' r el at or s who br i ng

a per se appr oach. The Uni t ed St at es t akes no posi t i on as t owhet her Dr . Ge' s compl ai nt s cont ai n suf f i ci ent al l egat i ons t o st at ea cl ai m f or pur poses of Rul e 12( b) ( 6) . Nor does t he Uni t ed St at est ake a posi t i on as t o whet her Dr . Ge' s pl eadi ngs sat i sf y t hepar t i cul ar i t y r equi r ement of Rul e 9( b) .

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FCA damages cl ai ms based on i nf or mat i on wi t hi nt he publ i c domai n or t hat t he r el at or di d notot her wi se di scover , " Uni t ed St at es ex r el .Rost v. Pf i zer , I nc. , 507 F. 3d 720, 727 ( 1stCi r . 2007) .

For t hose r easons, t her e ar e a number of l i mi t at i ons on qui t am

act i ons, i ncl udi ng t he par t i cul ar i t y requi r ement s of Rul e 9( b) .

As we expl ai ned i n Uni t ed St at es ex rel . Kar vel as v.

Mel r ose- Wakef i el d Hospi t al , 360 F. 3d 220 ( 1st Ci r . 2004) :

[ A] r el at or must pr ovi de det ai l s t hat i dent i f ypar t i cul ar f al se cl ai ms f or payment t hat wer esubmi t t ed t o t he government . I n a case suchas t hi s, det ai l s concer ni ng t he dat es of t hecl ai ms, t he cont ent of t he f or ms or bi l l ssubmi t t ed, t hei r i dent i f i cat i on number s, t heamount of money charged t o t he gover nment , t hepar t i cul ar goods or ser vi ces f or whi ch t hegover nment was bi l l ed, t he i ndi vi dual si nvol ved i n t he bi l l i ng, and t he l engt h oft i me bet ween t he al l eged f r audul ent pr act i cesand t he submi ss i on of cl ai ms based on t hosepr act i ces ar e t he t ypes of i nf or mat i on t hatmay hel p a r el at or t o st at e hi s or her cl ai mswi t h par t i cul ar i t y. These det ai l s do notconst i t ut e a checkl i st of mandat or yr equi r ement s t hat must be sat i sf i ed by eachal l egat i on i ncl uded i n a compl ai nt . However ,. . . we bel i eve t hat "some of t hi si nf or mat i on f or at l east some of t he cl ai msmust be pl eaded i n or der t o sat i sf y Rul e9( b) . "

I d. at 232- 33 ( quot i ng Uni t ed St at es ex rel . Cl ausen v. Lab. Cor p.

of Am. , 290 F. 3d 1301, 1312 n. 21 ( 11t h Ci r . 2002) ) . Kar vel as al so

r ej ect s t he not i on t hat t he Rul e 9( b) pl eadi ng st andar d i s r el axedf or FCA cl ai ms. See i d. at 228- 31.

I n a qui t am act i on i n whi ch t he def endant i s al l eged t o

have i nduced t hi r d par t i es t o f i l e f al se cl ai ms wi t h t he

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gover nment , a rel at or can sat i sf y t hi s r equi r ement by "pr ovi di ng

' f act ual or st at i st i cal evi dence t o st r engt hen t he i nf er ence of

f r aud beyond possi bi l i t y' wi t hout necessar i l y pr ovi di ng det ai l s as

t o each f al se cl ai m. " Duxbur y I , 579 F. 3d at 29 ( quot i ng Rost , 507

F. 3d at 733) .

Because FCA l i abi l i t y at t aches onl y t o f al se cl ai ms,

Kar vel as, 360 F. 3d at 225, mer el y al l egi ng f act s r el at ed t o a

def endant ' s al l eged mi sconduct i s not enough, Rost , 507 F. 3d at

732- 33. Rat her , a compl ai nt based on 3729( a) ( 1) ( A) must

"suf f i ci ent l y est abl i sh t hat f al se cl ai ms wer e submi t t ed f or

gover nment payment " as a resul t of t he def endant ' s al l eged

mi sconduct . Rost , 507 F. 3d at 733.

We wi l l assume t hat t he di st r i ct cour t was cor r ect t hat ,

as t o the al l egat i ons of f r aud on t he FDA, t he al l eged mi sconduct

suf f i ces. Dr . Ge has, however , al l eged next t o no f act s i n suppor t

of t he pr oposi t i on t hat Takeda' s al l eged mi sconduct r esul t ed i n t he

submi ssi on of f al se cl ai ms or f al se st at ement s mat er i al t o f al se

cl ai ms f or gover nment payment . Dr . Ge al l eges a concl usi on t hat

numerous cl ai ms f or t he f our subj ect dr ugs woul d not have been

submi t t ed f or government payment but f or Takeda' s mi sconduct , but

al l eges no more t han t hat . What i s mi ssi ng are any suppor t i ng

al l egat i ons upon whi ch her concl usi on r est s and any par t i cul ar s.

Dr . Ge' s pl eadi ngs f al l f ar shor t of what was f ound bar el y adequat e

i n Duxbur y I , see 579 F. 3d at 29- 30, and ar e f ar l ess par t i cul ar

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t han t hose t her e whose suf f i ci ency was deemed a "cl ose cal l , " i d.

at 30.

Ther e, t hi s cour t r eversed t he di st r i ct cour t ' s di smi ssal

under Rul e 9( b) of some of t he r el at or ' s cl ai ms, r easoni ng t hat t he

r el at or ' s i dent i f i cat i on of ei ght speci f i c medi cal pr ovi der s who

al l egedl y submi t t ed f al se cl ai ms, pl us r ough t i me per i ods,

l ocat i ons, and amount s of t he cl ai ms, and t he speci f i c gover nment

progr ams t o whi ch t he cl ai ms were made, were j ust enough t o

const i t ut e a pl eadi ng of f r aud wi t h par t i cul ar i t y. I d. at 30. 4

Her e, by cont r ast , Dr . Ge pr ovi ded i n r esponse t o t he mot i ons t o

di smi ss, at most , aggr egat e expendi t ur e dat a f or one of t he f our

subj ect dr ugs, wi t h no ef f or t t o i dent i f y speci f i c ent i t i es who

submi t t ed cl ai ms or government pr ogr am payers, much l ess t i mes,

amounts, and ci r cumst ances.

Dr . Ge t hus made no at t empt i n her compl ai nt s t o al l ege

f act s t hat woul d show t hat some subset of cl ai ms f or government

payment f or t he f our subj ect dr ugs was render ed f al se as a r esul t

of Takeda' s al l eged mi sconduct . And any t heor y t hat al l cl ai ms

submi t t ed dur i ng t hi s per i od wer e f al se has even l ess basi s t o

sur vi ve. Dr . Ge at t empt s t o sat i sf y t he Rul e 9( b) r equi r ement s

wi t h a per se r ul e t hat i f suf f i ci ent al l egat i ons of mi sconduct ar e

4 Af t er di scover y, t hose ver y cl ai ms wer e di smi ssed onsummar y j udgment as unsuppor t ed. Uni t ed Stat es ex r el . Duxbur y v.Or t ho Bi ot ech Pr ods. , L. P. , No. 03- 12189- RWZ, 2012 WL 3292870 ( D.Mass. Aug. 13, 2012) , af f ' d, 719 F. 3d 31 ( 1st Ci r . 2013) .

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made, i t necessar i l y f ol l ows t hat f al se cl ai ms and/ or mat er i al

f al se i nf or mat i on wer e f i l ed. We r ej ect t hat appr oach, whi ch

vi ol at es t he speci f i ci t y r equi r ement s of Rul e 9( b) .

On appeal , Dr . Ge ar t i cul at es t hr ee new t heor i es

pur por t i ng t o suppor t t he not i on t hat al l cl ai ms submi t t ed dur i ng

t he rel evant per i od f or t he f our subj ect dr ugs must have been

r ender ed f al se by Takeda' s al l eged mi sconduct ; and t hat al l egat i ons

of f al si t y woul d per se suf f i ce t o const i t ut e compl i ance wi t h Rul e

9( b) . Al l t hr ee t heor i es ar e wai ved, however , not havi ng been

r ai sed pr oper l y bef or e t he di st r i ct cour t .

We do not r ul e on whet her , had t hey not been wai ved, any

of t hese t heor i es under any subsect i on woul d have added t he needed

speci f i ci t y under Rul e 9( b) , and mer el y say i t i s doubt f ul . 5 See

Cl ausen, 290 F. 3d at 1311 ( comment i ng t hat Rul e 9( b) does not

per mi t an FCA pl ai nt i f f "mer el y t o descr i be a pr i vat e scheme i n

det ai l but t hen t o al l ege si mpl y and wi t hout any st at ed r eason f or

hi s bel i ef t hat cl ai ms r equest i ng i l l egal payment s must have been

submi t t ed, wer e l i kel y submi t t ed or shoul d have been submi t t ed t o

5 We r ecogni ze t hat , under Al l i son Engi ne Co. v. Uni t edSt ates ex r el . Sander s, 553 U. S. 662 ( 2008) , as const r ued i n Gagne,565 F. 3d at 46 & n. 7, t he "present ment " r equi r ement appl i es onl y t o

her subsect i on ( a) ( 1) ( A) cl ai ms and not her subsect i on ( a) ( 1) ( B) orsubsect i on ( a) ( 1) ( C) cl ai ms. However , Rul e 9( b) ' s par t i cul ar i t yr equi r ement appl i es wi t h f ul l f or ce t o al l t hr ee subsect i ons. SeeGagne, 565 F. 3d at 42, 45. Her e, Dr . Ge has not al l eged i n hersecond amended compl ai nt s, wi t h speci f i ci t y, f act s t hat compl y wi t hRul e 9( b) as t o any of her cl ai ms. I n any event , as di scussedi nf r a, her new t heor i es of FCA l i abi l i t y wer e wai ved.

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t he [g] over nment " ) ; see al so Uni t ed St at es ex r el . Nat han v. Takeda

Phar m. N. Am. , I nc. , 707 F. 3d 451, 457 ( 4t h Ci r . 2013) ( " [ We] hol d

t hat when a def endant ' s act i ons, as al l eged and as r easonabl y

i nf er r ed f r om t he al l egat i ons, coul d have l ed, but need not

necessar i l y have l ed, t o t he submi ssi on of f al se cl ai ms, a r el at or

must al l ege wi t h par t i cul ar i t y t hat speci f i c f al se cl ai ms actual l y

were present ed t o the government f or payment . " ( emphasi s added) ) ;

Uni t ed St at es ex r el . At ki ns v. McI nt eer , 470 F. 3d 1350, 1359 ( 11t h

Ci r . 2006) ( "[ Rel at or ] has descr i bed i n det ai l what he bel i eves i s

an el aborat e scheme f or def r audi ng t he government by submi t t i ng

f al se cl ai ms. . . . [ Rel at or ] f ai l s to pr ovi de t he next l i nk i n t he

FCA l i abi l i t y chai n: showi ng t hat t he def endant s act ual l y submi t t ed

r ei mbur sement cl ai ms f or t he servi ces he descr i bes. " ) .

A. I mpl i ed War r ant y

Dr . Ge' s f i r st addi t i onal t heor y of per se i nel i gi bi l i t y

f or f eder al r ei mbur sement of al l cl ai ms f or t he f our dr ugs r est s on

t he asser t i on t hat t he subj ect dr ugs wer e not "as saf e as Takeda

pur por t ed t hem t o be. " Dr . Ge cont ends t hat t hr ough l abel s and

par t i ci pat i on i n t he adver se event r epor t i ng pr ocess, Takeda

r epr esent ed t o al l pat i ent s, doct or s, and t he gover nment t hat t he

subj ect dr ugs possessed cer t ai n r i sks and benef i t s. Dr . Ge

al l eges, however , t hat t he subj ect dr ugs " di d not possess t he

saf et y pr of i l e Takeda cl ai med t hey woul d. " And f r om t hi s Dr . Ge

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i nf er s t hat she has adequat el y st at ed t hat al l cl ai ms submi t t ed t o

t he government f or t hose dr ugs were f al se.

Dr . Ge' s f i r st t heor y i s wai ved, havi ng been r ai sed onl y

i n "cur sor y f ashi on" bef or e t he di st r i ct cour t . See Rodr guez v.

Muni ci pal i t y of San J uan, 659 F. 3d 168, 175 ( 1st Ci r . 2011) ( " I t

shoul d go wi t hout sayi ng t hat we deem wai ved cl ai ms not made or

cl ai ms adver t ed to i n a cur sor y f ashi on, unaccompani ed by devel oped

ar gument . ") . Dr . Ge asser t ed t o t he di st r i ct cour t onl y t hat

Takeda' s al l eged f r audul ent conduct l ed t o t he submi ssi on of cl ai ms

t hat woul d not have ot her wi se occur r ed, wi t hout pr ovi di ng any

speci f i ci t y, and al l egi ng not hi ng mor e. But t hat i s i nadequat e;

cour t s shoul d not be asked t o guess t he cont ent s of a theory of

l i abi l i t y. "[ I ] ssues adver t ed t o i n a per f unct or y manner ,

unaccompani ed by some ef f or t at devel oped ar gument at i on, ar e deemed

wai ved. " Uni t ed St at es v. Zanni no, 895 F. 2d 1, 17 ( 1st Ci r . 1990) .

Dr . Ge di d of f er a bi t mor e ar gument at i on i n her Rul e

59( e) mot i on f or reconsi der at i on. That was t oo l at e. "To t he

ext ent t hat appel l ant s' r econsi der at i on mot i on sought t o r ai se an

ar gument wai ved at t he t r i al st age, i t must necessar i l y f ai l . "

Di Mar co- Zappa v. Cabani l l as, 238 F. 3d 25, 34 ( 1st Ci r . 2001) .

B. "Reasonabl e and Necessar y"

Dr . Ge on appeal i nvokes 42 U. S. C. 1395y( a) ( 1) ( A) ,

whi ch pr ohi bi t s Medi care payment s f or t r eatment s t hat are not

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" r easonabl e and necessary. "6 Accor di ng t o Ge, as a r esul t of

Takeda' s al l eged mi sconduct , cer t ai n r ei mbur sement cl ai ms wer e

r ender ed f al se under t he FCA because t hey i mpl i edl y - - and

i ncor r ect l y - - cer t i f i ed t hat t he subj ect dr ugs wer e "r easonabl e

and necessary. "

No such t heor y was proper l y pr esent ed t o t he di st r i ct

cour t bef or e di smi ssal . Dr . Ge concedes t hat she di d not ci t e or

di scuss 42 U. S. C. 1395y( a) ( 1) ( A) bef or e t he di st r i ct cour t i n her

memorandum i n opposi t i on t o Takeda' s mot i ons t o di smi ss. Dr . Ge

di d pr ovi de a bar e ci t at i on of 1395y( a) ( 1) ( A) i n her second

amended compl ai nt s. However , Dr . Ge di d not al l ege i n t hose

compl ai nt s t hat Takeda' s al l eged mi sconduct r ender ed cl ai ms f or t he

f our subj ect dr ugs " [ un] r easonabl e" or " [ un] necessary. " Nor di d

she make any ef f or t t o expl ai n why that woul d be so. See Pan v.

Gonzal es, 489 F. 3d 80, 87 ( 1st Ci r . 2007) ( "We l ong have hel d t hat

l egal t heor i es advanced i n skel etal f orm, unaccompani ed by some

devel oped ar gument at i on, ar e deemed abandoned. " ) .

C. "Mi sbr anded"

On appeal Dr . Ge newl y argues t hat f al se cl ai ms must have

been submi t t ed t o the government f or t he f our dr ugs on t he t heor y

t hat Takeda' s f ai l ur e t o pr oper l y updat e t he subj ect dr ugs' l abel s

6 Var i ous st at e st at ut es and r egul at i ons gover ni ng Medi cai dr ei mbur sement i mpose si mi l ar r est r i ct i ons. See, e. g. , 130 Mass.Code Regs. 450. 204 ( "The MassHeal t h agency wi l l not pay a pr ovi derf or ser vi ces t hat ar e not medi cal l y necessar y . . . . ") ( emphasi sadded) .

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caused t hose dr ugs t o be "mi sbr anded" f or pur poses of t he f eder al

Food, Dr ug, and Cosmet i cs Act ( "FDCA") , 21 U. S. C. 352( a) , and so

t hey wer e i nel i gi bl e t o ent er i nt er st at e commer ce, i d. 331( a) .

Consequent l y, she now says t hey wer e i nel i gi bl e f or r ei mbur sement .

At best , t her e was a gest ur e t o Dr . Ge' s " mi sbr andi ng" t heor y

bef or e t he t r i al cour t , and i t i s wai ved.

Dr . Ge r ej oi ns t hat she di d adequat el y r ai se a

"mi sbr andi ng" ar gument bef or e t he di st r i ct cour t . Her second

amended compl ai nt s al l eged t hat Takeda f ai l ed t o update t he l abel

f or Act os t o accur at el y r ef l ect t he dr ug' s r i sks, as r equi r ed by

t he FDCA. However , as t o i nel i gi bi l i t y, Dr . Ge' s compl ai nt s st at e

onl y: " [ The FDCA] f or bi ds ' mi sbr andi ng' and pr ovi des a r ange of

ci vi l and cr i mi nal enf or cement mechani sms agai nst i naccur at e

pr oduct l abel i ng. " Dr . Ge made no ment i on of i nel i gi bi l i t y f or

i nt er st at e commer ce, l et al one of i nel i gi bi l i t y f or r ei mbur sement

on t hat basi s. At most , a f oot not e i n her memorandum opposi ng

di smi ssal r ef er r ed t o mi sbrandi ng but nothi ng more. The argument

was wai ved. See Ci t y of Bangor v. Ci t i zens Commc' ns Co. , 532 F. 3d

70, 95 n. 11 ( 1st Ci r . 2008) ( deemi ng wai ved argument "pr esent ed

onl y i n a passi ng f ashi on i n a f oot not e" ) . The ment i on of

mi sbr andi ng i n Dr . Ge' s Rul e 59( e) mot i on was t oo l i t t l e, t oo l at e.

See Cochr an v. Quest Sof t war e, I nc. , 328 F. 3d 1, 11 ( 1st Ci r . 2003)

( "Li t i gat i on i s not a game of hopscot ch. I t i s gener al l y accept ed

t hat a par t y may not , on a mot i on f or r econsi der at i on, advance a

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new argument t hat coul d ( and shoul d) have been pr esent ed pr i or t o

t he di s t r i ct cour t ' s or i gi nal rul i ng. " ) .

To sumup: Dr . Ge wai ved al l of her new arguments t o t he

ef f ect t hat t he f our subj ect dr ugs wer e per se i nel i gi bl e f or

government r ei mbur sement dur i ng t he r el evant per i od on t hese

var yi ng t heor i es. Dr . Ge' s cl ai ms on al l t heor i es whi ch wer e

pr esent ed f ai l under Rul e 9( b) .

I I I .

Thi s cour t r evi ews t he di st r i ct cour t ' s deni al of an

appel l ant ' s mot i on to amend and f or r econsi der at i on f or abuse of

di screti on. Fbr i ca de Muebl es J . J . l var ez, I ncor por ado v.

I nver si ones Mendoza, I nc. , 682 F. 3d 26, 31 ( 1st Ci r . 2012) ;

Tor r es- Al amo v. Puer t o Ri co, 502 F. 3d 20, 25 ( 1st Ci r . 2007) .

Dr . Ge ar gues t hat she coul d have cur ed any def ect s i n

her compl ai nt s had she been provi ded wi t h l eave t o amend the t wo

t i mes she asked. She had al r eady t wi ce amended bot h of her

compl ai nt s i n t he 21 mont hs af t er t he f i l i ng of her i ni t i al

compl ai nt . The f i r st r equest , af t er Takeda f i l ed i t s mot i on t o

di smi ss i n 2012, was i n her memorandum i n opposi t i on t o Takeda' s

mot i on t o di smi ss and condi t i onal l y di d st at e t hat i f t he cour t was

i ncl i ned t o di smi ss, t hen she woul d l i ke t o amend. 7 The di st r i ct

7 Ther e, Dr . Ge' s condi t i onal r equest t o amend consi st ed j ustof t wo sent ences:

I f t he Cour t wer e t o det er mi ne t hat Rel at or ' sCompl ai nt s are def i ci ent i n any regar d, Rel at orr espect f ul l y r equest s t hat t hi s Cour t af f or d her an

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cour t di d not expl i ci t l y di scuss t he r equest , but di d di scuss t he

addi t i onal appended mater i al on Act os and sai d i t di d not cur e t he

def i ci enci es i n t he pl eadi ng.

The second of her r equest s came i n t he f or m of a mot i on

t o amend, f i l ed post - j udgment on November 29, 2012 i n conj unct i on

wi t h her mot i on f or r econsi der at i on under Rul e 59( e) of t he

j udgment of di smi ssal . The di st r i ct cour t di smi ssed t hi s l at e

mot i on wi t hout opi ni on i n i t s December 18, 2012 or der .

When a mot i on t o amend i s proper l y made bef or e ent r y of

j udgment , t he di st r i ct cour t i s t o eval uat e t hat mot i on under t he

"l i ber al st andar d of Fed. R. Ci v. P. 15( a) . " Pal mer v. Champi on

Mor t g. , 465 F. 3d 24, 30 ( 1st Ci r . 2006) . "Amendment s may be

per mi t t ed pr e- j udgment , even af t er a di smi ssal f or f ai l ur e t o st at e

a cl ai m, and l eave t o amend i s ' f r eel y gi ven when j ust i ce so

r equi r es. ' " I d. ( quot i ng Fed. R. Ci v. P. 15( a) ) . The "r equest "

was not pr oper l y made.

By cont r ast , as t o post - j udgment mot i ons " a di st r i ct

cour t cannot al l ow an amended pl eadi ng wher e a f i nal j udgment has

oppor t uni t y t o amend her compl ai nt . Feder al Rul eof Ci vi l Pr ocedur e 15( a) pr ovi des t hat l eave t oamend a pl eadi ng "shal l be f r eel y gi ven when

j ust i ce so r equi r es, " and r ef l ect s a l i beralamendment pol i cy. O' Connel l v. Hyat t Hotel s ofP. R. , 357 F. 3d 152, 154 ( 1st Ci r . 2004) ; Rost , 507F. 3d at 733- 34 ( same) ; see al so Foman v. Davi s, 371U. S. 178, 182 ( 1962) ( l eave t o amend shoul d be"f r eel y gi ven") .

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been r ender ed unl ess t hat j udgment i s f i r st set asi de or vacat ed

pur suant t o Fed. R. Ci v. P. 59 or 60. " Mal donado v. Domi nguez, 137

F. 3d 1, 11 ( 1st Ci r . 1998) . "The gr ant i ng of a mot i on f or

r econsi der at i on i s ' an ext r aor di nar y r emedy whi ch shoul d be used

spar i ngl y. ' " Pal mer , 465 F. 3d at 30 ( quot i ng 11 Char l es Al an

Wr i ght et al . , Feder al Pr act i ce and Pr ocedur e 2810. 1 ( 2d ed.

1995) ) . The movi ng par t y "must ' ei t her cl ear l y est abl i sh a

mani f est er r or of l aw or must pr esent newl y di scover ed evi dence. ' "

Mar i e v. Al l i ed Home Mor t g. Cor p. , 402 F. 3d 1, 7 n. 2 ( 1st Ci r .

2005) ( quot i ng Pomer l eau v. W. Spr i ngf i el d Pub. Schs. , 362 F. 3d

143, 146 n. 2 ( 1st Ci r . 2004) ) . A mot i on f or r econsi der at i on

"cer t ai nl y does not al l ow a par t y t o i nt r oduce new evi dence or

advance argument s t hat coul d and shoul d have been present ed t o t he

di st r i ct cour t pr i or t o t he j udgment . " Aybar v. Cr i spi nReyes, 118

F. 3d 10, 16 ( 1st Ci r . 1997) ( quot i ng Mor o v. Shel l Oi l Co. , 91 F. 3d

872, 876 ( 7t h Ci r . 1996) ) .

Dr . Ge rel i es on Foman v. Davi s, 371 U. S. 178 ( 1962) ,

whi ch st at ed:

Of cour se, t he gr ant or deni al of anoppor t uni t y t o amend i s wi t hi n t he di scr et i onof t he Di st r i ct Cour t , but out r i ght r ef usal t ogr ant t he l eave wi t hout any j ust i f yi ng r easonappear i ng f or t he deni al i s not an exer ci se of

di scret i on; i t i s mer el y abuse of t hatdi scret i on and i nconsi st ent wi t h t he spi r i t oft he Feder al Rul es.

I d. at 182. Dr . Ge cont ends t hat t he di st r i ct cour t ' s deni al s

wi t hout a st at ement of r easons f or her t wo request s amount ed t o

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j ust t he sor t of "out r i ght r ef usal . . . wi t hout any j ust i f yi ng

r eason" t hat Foman pr oscr i bes.

As expl ai ned i n Si l ver st r and I nvest ment s v. AMAG

Phar maceut i cal s, I nc. , 707 F. 3d 95, 107- 08 ( 1st Ci r . 2013) , wher e,

as her e, a request t o f i l e an amended compl ai nt consi st s of not hi ng

mor e t han "boi l er pl at e sent ences st at i ng t he wel l - set t l ed ' f r eel y

gi ven' st andard under whi ch a request f or l eave to amend i s

gener al l y anal yzed, " a di st r i ct cour t "act[ s] wel l wi t hi n i t s

di scr et i on when compl et el y di sr egar di ng t he r equest . "8 I ndeed, i n

Gr ay v. Ever cor e Rest r uct ur i ng LLC, 544 F. 3d 320 ( 1st Ci r . 2008) ,

a case i nvol vi ng a near l y i dent i cal r equest , t hi s cour t expl ai ned

t hat except per haps i n "except i onal ci r cumst ances, " a bar e request

i n an opposi t i on t o a mot i on t o di smi ss does not const i t ut e a

mot i on t o amend f or pur poses of Rul e 15( a) . I d. at 327 ( "Al t hough

a cour t ' s deni al of a mot i on t o amend i s t ypi cal l y r evi ewed f or an

abuse of di scr et i on, i n t hi s case t he di st r i ct cour t nei t her

gr ant ed nor deni ed a mot i on t o amend. . . . As [pl ai nt i f f ] f ai l ed

t o r equest l eave t o amend, t he di st r i ct cour t cannot be f aul t ed f or

f ai l i ng t o gr ant such l eave sua spont e. ") ; accor d Fi sher v. Kadant ,

8 Dr . Ge ar gues t hat Si l ver st r and i s i napposi t e because her

post - di smi ssal r equest f or l eave t o amend consi st ed of sever alpages of ar gument and was accompani ed by t wo pr oposed amendedcompl ai nt s and st at i st i cal and anecdot al evi dence of t he ef f ect s ofTakeda' s al l eged mi sconduct . Dr . Ge' s second r equest i s nei t herher e nor t her e wi t h r espect t o whet her t he di st r i ct cour t ' sr ej ect i on of her f i r st , "boi l er pl at e" r equest amount ed t o an abuseof di scr et i on.

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I nc. , 589 F. 3d 505, 509- 10 ( 1st Ci r . 2009) . And even at t hat ,

Foman i dent i f i es " r epeat ed f ai l ur e t o cur e def i ci enci es by

amendment s pr evi ousl y al l owed" as r eason f or denyi ng a mot i on f or

l eave t o amend under t he permi ss i ve Rul e 15( a) st andard. 371 U. S.

at 182.

Ther e was al so no abuse i n denyi ng Dr . Ge' s second

r equest . I t came af t er j udgment , when t he l i ber al l eave t o amend

l anguage of Rul e 15( b) does not appl y. I d. I n or der t o gr ant Dr .

Ge' s second r equest , t he di st r i ct cour t woul d have had f i r st t o set

asi de i t s j udgment pur suant t o Dr . Ge' s mot i on t o r econsi der under

Rul e 59( e) . I t di d not and di d not abuse i t s di screti on.

Her argument , i n any event , has no l egs. Dr . Ge coul d

har dl y cont end t hat t he so- cal l ed "newl y di scover ed evi dence"

accompanyi ng her second r equest was "not pr evi ousl y avai l abl e. "

Pal mer , 465 F. 3d at 30. Dr . Ge coul d have sought t he t est i mony of

an exper t wi t ness and/ or subj ect dr ug users much ear l i er . Nor

coul d Dr . Ge pl ausi bl y i dent i f y some "mani f est er r or of l aw"

commi t t ed by t he di st r i ct cour t . I d.

The di st r i ct cour t ' s di smi ssal or der i dent i f i ed t he

evi dent i ar y def ect s i n Dr . Ge' s compl ai nt s af t er Dr . Ge had t wi ce

amended her compl ai nt s and af t er havi ng consi der ed ar guendo Dr .

Ge' s cont est ed decl arat i on and accompanyi ng expendi t ur e data. As

t hi s cour t has st at ed pr evi ousl y:

To r equi r e t he di st r i ct cour t t o permi tamendment her e woul d al l ow pl ai nt i f f s t o

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pur sue a case t o j udgment and then, i f t heyl ose, t o r eopen t he case by amendi ng thei rcompl ai nt t o t ake account of t he cour t ' sdeci si on. Such a pr act i ce woul d dr amat i cal l yunder mi ne t he ordi nary r ul es gover ni ng t hef i nal i t y of j udi ci al deci si ons, and shoul d not

be sanct i oned i n t he absence of compel l i ngci r cumst ances.

J ames v. Wat t , 716 F. 2d 71, 78 ( 1st Ci r . 1983) ( Br eyer , J . ) . So

t oo, her e.

I V.

We af f i r mt he di st r i ct cour t ' s or der s di smi ssi ng r el at or

Dr . Ge' s cl ai ms and denyi ng l eave t o amend her second amended

compl ai nt s. Cost s are awarded t o Takeda.

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us ex rel. ge v. takeda pharmaceutical company, 1st cir. (2013)

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