2010 D e c i sion s O p inion s of the U nit e d S t at e s C our t of Appe al s for the Thir d C ir c uit 4-14-2010 

# In Re: D iet D ru gs P r e c e de nt i al or N on-P r e c e de nt i al : N on-P r e c e de nt i al D ocke t N o . 09-2424

F o llow thi s and a dd it ion al work s at : http://d i git alc ommon s .l a w . vi ll anova . e du/thir dc ir c uit_2010

Thi s de c i sion i s br ou ght t o you for f r e e and ope n a c c e s s b y the O p inion s of the U nit e d S t at e s C our t of Appe al s for the Thir d C ir c uit at V i ll anova U nive r sity S choo l of L a

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w . vi ll anova . e du/thir dc ir c uit_2010/1512H onor abl e J ane A . R es t ani , C hi ef J udge of the U ni t ed St at es C our tof * I nt ernat i onal T r ade, s i t t i ng bydes i gnat i on. NOT P RE CE DE NT I AL U N IT E D S T A T E S C O U R T O F A P P E A L S F O R T H E T H IR D C IR C U IT N o. 09- 2424 I N R E: DI ET DR UG S ( PHEN TERM I NE/ FENFLURA M I NE/ DEX FENFLURA M I NE) P RO DUC T L I AB I L I T Y L I T I GAT I ON DE NI S E S WANI GAN, A ppel l ant

O n A p p ea l from the U n it ed S tat es D istri ct C o u rt f o r th e E a ste rn D istric t o f P e n n sy lv a n ia ( D . C . C i vi l N o. 99- 20593) D i s t r i ctJ udge: H onor abl e H arveyB art l e, I I I , C hi ef J udge

Subm i t t ed U nderT hi r d C i r cui tL A R 34. 1( a)

A pr i l 13, 2010 B efor e: SL O V I T E R , N Y G A A R D , C i r cui tJ udges , and R E ST A N I , J udge * ( Fi l ed: A pr i l 14, 2010)

OP I NI ON R E S T A N I, Judge .P r i o rt o M a r c h 2 0 0 2 , W y e t h Co rp o r a t i o n wa s k n o wn a s Ame r i c a n Ho me 1 P rod u cts C o rpo rati o n (“A H P ”). T he s ett l ementcl as s i ncl udes “[a ] l l per s ons . . . w ho i nges t ed [di etdrugs ] ” eve n 2 a f te r t h e a c tio n b e g a n . (A p p . 1 1 0 .) 2 D eni s e Sw ani gan appe al s t he or derof the U ni t ed St at es D i s t r i ctC our tforthe E a ste rn D istric t o f

P e n n sy lv a n ia a f

f irm in g a n a rb itrato r’s d e n ial o f a d d iti o n a l b e n e f

its underthe D i etD rug N at i onw i de C l as s A ct i on Set t l ementA gr eement( “Set t l ement A g re e m e n t” ) w ith W y e th C o rp o ra tio n (“ W y e th ” ). W e w ill a f f ir m . 1 I. Sw ani gan, a cl as s m emberunderthe Set t l ementA gr eement , s eeks benef i t s fr om th e AHP S e t t l e me n tT ru s t( “ T ru s t ” ) , wh i c h wa s e s t a b l i s h e d t o r e s o l v e c l a i ms a g a i n s tAHP ar i s i ng fr om t he s al e, di s t r i but i on, and us e of c ert ai n di etdrugs . Sw ani gan s ubm i t t ed a 2 Pi nk For m i n A ugus t2000 t o r egi s t erw i t h t he Trus tand att ache d a s uppor t i ng decl ar at i on byD r. A l bertB row n (“B row n D ecl arat i on ”) t o p rove dietdrug ingest i on . T he T rust det erm i ned thats he w as el i gi bl e t o r ece i ve a s cr eeni ng echoc ar di ogr am and a par t i al r e f u n d f o rt h e d i e td ru g s . Af

t e rh e rs c r e e n i n g , S wa n i g a n r e c e i v e d a $ 6 , 0 0 0 “ F DA P o sit ive” ca sh b en ef

it , w h ich s ign ifi ed that sh e e x h ibit ed so m e n o n -tri v ial leve l of h ea rt val ve l eaka ge, and a $500 Pr es cr i pt i on R ei m bur s ementbenef i t . I n J anuary2003, Sw ani gan s ubm i t t ed a G r een Form t o t he Trus ts t at i ng thatherm edi cal condi t i on ent i t l ed h e r t o a d d itio n a l b e n e f

its . I n Sept ember2003, t he Trus ti s s ued a de fi ci encynot i ce t o Sw ani gan bec aus e her3

p ro o f o f in g e s tio n d o c u m e n ts d id n o t m e e t th e re q u ir e m e n ts o f th e S e ttle m e n t A g re e m e n t. In N o v e m b e r 2 0 0 3 , S w a n ig a n w ro te to th e T ru st in d ica tin g th a t sh e w a s u n a b le to lo c a te D r . B r ow n, and s he s ubm i t t ed af fi davi t s fr om herm other , co- w or ker , fami l ydoct or , and hersel f. B et w een N ov em ber 200 3 an d S eptem ber 200 6, C l ass C ou nsel and the T rust cont act ed Sw ani gan s ever al t i m es byl ett erand t el ephone t o i nqui r e aboutherdi etdrug pr es cr i pt i on. Sw ani gan pr ovi ded no furt herpr oof of di etdrug i nges t i on. I n Sept ember 2006, the Trus tdeni ed Sw ani gan’ s G r een Form cl ai m foraddi t i onal benef i t s . Sw ani gan appea l ed the Trus t ’ s deni al , and the mat t erw as r efe r r ed t o arbi t r at i on pur s uantt o t he S e ttle m e n t A g re e m e n t. T he arbi t r at ori s s ued a r epor tand aw ar d aff i r m i ng the Trus t ’ s det erm i nat i on, w hi ch Sw ani gan appe al ed t o t he D i s t r i ctC our t . I n A pr i l 2008, the D i s t r i ctC our taff i r m ed the arbi tr at or ’ s r epor tand aw ar d, B r ow n v. A m . H om e Pr ods . C orp. ( I n r e D i etD rugs ) , N o. 99- 20593, 2008 W L 1776443 ( E . D . Pa. 2008) , and deni ed Sw ani gan’ s s ubs equentm ot i on for r econ si derat i on and peti t i on t o sub m i tnew evidence. S w anigan n ow app eal s tho se d e c is io n s . II. T hi s C our thas j ur i s di ct i on pur s uantt o 28 U . S. C . § 1291. W hen r evi ew i ng a d istri ct co u rt ’s ord er c o n firm ing an arb itrati o n aw ard , w e re v iew the d istri ct co u rt ’s fin d ing s o f f

ac t fo r clear e rror an d ex erc ise p lena ryrev iew o v er the d istri ct co u rt ’s det erm i nat i on of ques t i ons of l aw . C hi na M i nm et al s M at er i al s I m p. & E xp. C o. , v. C hiI ti s undi s put ed thatSw ani gan di d nots ubm i tanypharm acyorm edi cal r ecor ds 3 document i ng di etdrug us e. 4 M ei C orp. , 334 F. 3d 274, 278 ( 3d C i r . 2003) ( ci t i ng Fi r s tO pt i ons of C hi cago, I nc. v. K a p la n , 5 1 4 U .S . 9 3 8 , 9 4 7

– 4 8 (1 9 9 5 )) . III . Sw ani gan appe al s , cont endi ng thats he pr ovi ded s uffi ci entpr oof of di etdrug i ng est i on . In the ev ent that this C ou rtdo es not agree, S w anigan argues t hat the T rust s h o u l d b e e q u i t a b l ye s t o p p e d f r o m d e n y i n g h e rc l a i m. Al t e r n a t i v e l y , S wa n i g a n c l a i ms thatthi s C our ts houl d bart he Trus tfr om r equi r i ng Sw ani gan t o s ubs t ant i at e herdi etdrug ing esti o n u n d er the d o ctri n e o f lac h es. S w an igan also arg u es th at th e P ink F o rm cons t i tut ed a c ont r actw hi ch r equi r ed W y eth t o cons i derherpr oof of di etdrug i nges t i on su f f icie n t f o r a d d iti o n a l b e n e f

its. F in a lly , S w a n ig a n se e k s to a d m it tw o d o c u m e n ts re g a rd in g D r. B ro w n a s f u rth e r p ro o f

o f h e r d iet d ru g in g e stio n . W e w ill a d d re ss e a c h in tur n. T h e S e ttl e m e n t A g re e m e n t re q u ire s “ d o c u m e n tar yp ro o f ” o f d iet d ru g in g e stio n to co m p let e the su b m issi o n o f a claim . (A p p . 1 8 5 . ) If p h arm ac yo r m ed ical reco rds a re unobt ai nabl e, t he “pr oof m us ti ncl ude . . . an af fi davi t. . . fr om the pr es cr i bi ng phy s i ci an 3
ordi s pens i ng pharm acyi dent i fy i ng the D i etD rug R eci pi ent , the drug( s ) pr es cr i bed or d isp e n se d , the d a te( s), q u a n tity , fr e q u e n c y , d o sa g e a n d n u m b e r o f p re sc rip tio n s o r re f

ill s o f th e D iet D ru g (s) .” (A p p . 1 8 6 .) T h e B ro w n D e c lar a tio n w a s S w a n ig a n ’s a ttem p t to5

f u lf ill th is re q u ir e m e n t. T he D i s t r i ctC our tfound thatthe B r ow n D ecl ar at i on w as i ns uffi ci entt o pr ove di et drug i nges t i on beca us e: ( 1) t he t i m e per i od dur i ng w hi ch D r . B r ow n al l eged he di s pens ed th e d ru g s to S w a n ig a n w a s a m b ig u o u s; (2 ) th a t ti m e p e rio d w a s in c o n sis ten t w ith S w a n ig a n ’s a f

f id a v it reg a rd in g h e r d a tes o f u sa g e ; (3 ) D r. B ro w n a ttes ted th a t h e ill e g a lly di s pens ed the di etdrugs t o Sw ani gan af t erthe drugs w er e r emoved fr om the mar ket ; and ( 4) t he B r ow n D ecl ar at i on s t at es dos ages thatar e i ncons i s t entw i t h t he dos ages atw hi ch th e d ru g s w e re iss u e d . B ro w n , 2 0 0 8 W L 1 7 7 6 4 4 3 , at * 3

– 4 . T h e D istric t C o u rt sim ilarly f o u n d th a t S w a n ig a n ’s a f f id a v its h a d n o p ro b a tiv e v a lu e b e c a u se th e yd id n o t co m p lyw ith the t erm s of the Set t l ementA gr eement . I d. at*3 n. 6. E ven i f the af fi davi t s w er e pr oper form s of pr oof, none s uppl yanydet ai l r egar di ng Sw ani gan’ s di etdrug pr es cr i pt i on or in g e stio n a s re q u ire d b yth e S e ttl e m e n t A g re e m e n t. T h e D istric t C o u rt d id n o t er r w h e n it d e ter m in e d th a t S w a n ig a n d id n o t p ro v id e th e p ro o f o f d iet d ru g in g e stio n re q u ire d to supp orther cl ai m for add i t i on al ben efi t s. Sw ani gan’ s equi t abl e es t oppel cl ai m i s s i m i l ar l yunavai l i ng. E qui t abl e es t oppel

“ a rise s w h e n a p a rtyin ten tio n a llyo r th ro u g h c u lp a b le n e g lig e n c e in d u c e s a n o th e r to b e liev e c e rta in f

a c ts to e x ist a n d th e o th e r p a rtyrig h tf u llyre lies a n d a c ts o n su c h b e lief to it s d etri m en t. ” K ir lei s v . D ickie, M cC am ey& C h il co te, P . C . , 5 6 0 F . 3 d 1 5 6 , 1 6 5 (3d C ir . 2009) ( i nt ernal quot at i on m arks and ci t at i on om i t t ed) . N othi ng i n t he r ecor d s ugges t s t hat A ppel l ees m i s r epr es ent ed the s t atus of Sw ani gan’ s cl ai m , caus i ng hert o r emai n i nact i ve6

in p u rsu in g p ro p e r d o c u m e n tatio n o f in g e stio n f

ro m D r. B ro w n to h e r d e trim e n t. In f a c t, Sw ani gan ac know l edged thatt he che ck s tub forthe bene fi t s s he r ece i ved i n 2001 i nd i cat ed thati f she w ere t o fil e a G reen Fo rm , “t he T rustw i l l determ i ne D i etD rug use [and] dur at i on of us e . . . w i t houtr egar d t o anyof the Trus tdet erm i nat i ons w hi ch qual i fi ed [he r ] t o r ece i ve thi s [bene fi t ] . ” ( A pp. 85. ) T hus , Sw ani gan di d notpr ove that she detr i m ental l yrel i ed o n an ym i sr epresent at i on byA pp el l ees. S wa n i g a n a l s o a r g u e s t h a tt h e e q u i t a b l e d o c t r i n e o f l a c h e s i s a p p l i c a b l e h e r e . “ [ A] partys t i l l m us tunequi vocal l yputi t s pos i t i on befor e the tr i al cour tata poi ntand i n a m annerthatperm i t s t he courtt o cons i deri t s m er i t s . ” Shel l Petr ol eum, I nc. v. U ni t ed St at es , 182 F. 3d 212, 218 ( 3d C i r . 1999) . I ti s notcl earthatSw ani gan’ s m er e ment i on of the t erm “l ache s ” i n herbr i efs s uffi ci ent l yputthi s ar gum entbefor e the D i s t r i ctC our tand w e w i l l not“cons i deri s s ues t hatar e r ai s ed forthe fi r s tt i m e on appe al . ” I d. at219. E ven i f w e w er e t o deci de thatSw ani gan made a l ache s ar gum entthatw as notcons i der ed by the D i stri ctC ou rt , i tw ou l d n ot chang e t he o utcom e of thi s case. L aches i s m ost c o m m o n lyra ise d a s a n a f f irm a tiv e d e f

e n se to a law su it an d re q u ire s in e x c u sa b le d e lay i n br i ngi ng s ui tand pr ej udi ce t o t he def endantas a r es ul tof the del ay . See U ni v. of P itt sb u rg h v . C h a m p io n P ro d s., 6 8 6 F .2 d 1 0 4 0 , 1 0 4 4 (3 d C ir. 1 9 8 2 ). T h e f a c ts o f th is cas e do notfi tt hi s doctr i ne. I n anyevent , the D i s t r i ctC our tdi d noterri n det erm i ni ng thatthe Trus tpl ace d Sw ani gan on not i ce of the i ns uffi ci encyof herpr oof of di etdrug i n g e s t i o n w i t h i n n i n e m o n t h s o f s u b m i t t i n g h e rG r e e n F o r m c l a i m . S e e B r o w n , 2 0 0 8 WLT he Pi nk For m s t at es t hat“[t ] he Set t l ementA gr eement , i ncl udi ng, w i t hout 4 lim itatio n its b e n e f

its a n d its re lea se p ro v isio n s, is in c o rp o ra ted b yre f e re n c e in to th is In d iv id u a l A g re e m e n t a s if f u lly se t o u t a t le n g th .” (A p p . 2 9 .)

7 1776443, at*2. I tdoes nots eem r eas onabl e thatSw ani gan w oul d have c ons i der ed the T rust’s ri g h t t o ask fo r fu rth er su b stan ti ati o n o f d ietd rug ing esti o n ab an d o n ed af ter a m e re n in e m o n th s . Sw ani gan al s o ar gues t hatt he Pi nk For m cons t i tut ed a c ontr actbetw een Sw ani gan and W y eth and thatW y eth w as bound t o cons i derherpr oof of di etdrug i nges t i on s uffi ci entforaddi t i onal benef i t s . She gr ounds hercl ai m i n t he i ns t ruct i ons on t he Pi nk For m , w hi ch i ndi cat ed thatbys uppl y i ng cert ai n i nform at i on the appl i canthas “ful fi l l ed th[e] r equi r ement ” of di etdrug us age. ( A pp. 32. ) T he D i s t r i ctC our ti nt erpr et ed the Pi nk F o rm a s m e re ly im p le m e n tin g th e S e ttle m e n t A g re e m e n t a n d n o t m o d if y in g it in a n yw a y . B r ow n, 2008 W L 1776443, at*2. T he pl ai n m eani ng of the Pi nk For m ’ s l anguage su p p o rts th is in terp re tatio n . C o n se q u e n tly , the D istric t C o u rt d id n o t er r in its 4 d e ter m in a tio n th a t th e P in k F o rm d id n o t cr e a te a n e w a n d in d e p e n d e n t ag re e m e n t w ith th e T ru s t. F in a lly , S w a n ig a n se e k s to a d m it tw o d o c u m e n ts re g a rd in g D r. B ro w n . T h e f irst, a n I l l i n o i s Di v i s i o n o f

P r o f e s s i o n a l Re g u l a t i o n we b s i t e p r i n t - o u t , i n d i c a t e s th a tDr . Br o wn w as arres t ed an d, w hil e i n cu st od y , he instruct ed h i s unli censed em ploy ees t o d i spense co n tr o ll ed su b stan ce s in h is ab sen ce . T h e se co n d d o cu m en t i s an ap p o intm en t sum m ary al l egedl ys how i ng t hatD r . B r ow n r egul ar l ym etw i t h di etdrug s al es m en. Feder al R ul e ofA ppel l at e Pr ocedur e 10( e) ( 2) perm i t s thi s C our tt o corr ectthe omi s s i on of m at er i al

e v id e n c e f

ro m th e d is tr ic t c o u rt re c o rd . S e e F e d . R . A p p . P . 1 0 (e )( 2 ) ( e m p h a s is a d d e d ). T he evi dence Sw ani gan s eeks t o admi t , how ever , i s notm at er i al beca us e i tdoes not s u b s ta n tia te h e r c la im o f d ie t d ru g in g e s tio n .

I V. F o r th e f o re g o in g re a so n s, w e w ill a f f irm th e O rd e rs o f

th e D istric t C o u rt.

8