# U ni te d S ta te s Co ur t of A pp ea ls

For the Eig hth Circu it

__ __ __ __ __ __ __ __ __ __ __ __ __ _

No. 1 2- 29 45

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Jo y ce Fu ll in gt on

ll ll ll ll ll ll ll ll ll ll l Pla in ti

ff - App el la nt

v.

Pfi zer, In c.; Wy et h, LLC; Sch warz Ph arm a, In c.; P li va , Inc .; Al av en Ph arm aceu ti cal , LLC; Mu tu al Ph arm aceu ti cal Co m pa ny, Inc.

ll ll ll ll ll ll ll ll ll ll l Defe nd

an ts - App el le es

__ __ __ __ __ __
App eal fro m

Uni te d S ta te s Di st ric t Co ur t fo r th e Eas te rn Dis tri ct of Ark an sa s - Li tt le Ro ck

__ __ __ __ __ __

Su bm it te d: Marc h 1 4, 2 01 3
Fil ed : J ul y

15 , 20 13

__ __ __ __ __ __

Befo re MUR PHY, SMITH, an d GRUENDER, Ci rcu it Ju dg es

.

__ __ __ __ __ __

GRUENDER, Circ ui t J ud ge

.

Jo y ce Fu ll in gt on fil ed a pr od uc t li ab il it y su it ag ai ns t th e m an uf act ur ers of th e

pr es cri pt io n dr ug Reg la n an d it s ge ne ric eq ui va le nt

, m e to cl op ram id e. The di st ric t

co ur t ru le d th at al l of Fu ll in gt on ’s cl ai m s were ei th er no t vi ab le un de r Ark an sa s la w

or were pr eem

pt ed by fed eral la w go ve rn in g dr ug pr od uc t la be li n g

. We affi rm in

pa rt, re ve rs e in pa rt, a nd rem an d fo r fu rth er co ns id erat io n.I. Ba ck gr ou nd

Fro m Apr il 20 08 th ro ug h Apr il 20 09

, Fu ll in gt on in ge st ed th e pr es cri pt io n dr ug

m et oc lo pr am id e. Sh e su bs eq ue nt ly de ve lo pe d a ne ur ol og ic al di so rd er cal le d ta rd iv e dysk in e s i a , al le ge dl y as a res ul t of lo ng -te rm us e of m et oc lo pr am id e. In res po ns e,

Fu ll in gt on fil ed su it ag ai ns t two gr o u p s of ph arm aceu ti cal co m pa ni es , as se rti ng

cau se s of act io n un d e r Ark an sa s la w fo r ne gl ig en ce (in cl ud in g gr os s ne gl ig en ce),

st ric t li ab il it y , b reac h of th e im pl ie d warra nt ie s of m erch an ta bi li ty an d f i t n e s s fo r a

pa rti cu la r pu rp os e, m is rep res en ta ti on , su pp res sio n of ev id en ce, an d frau d. One gr ou p

of de fen da nt s are co m

pa ni es th at at so m e p o i n t

, ei th er di rect ly or th ro ug h

su bs id ia rie s, were in vo lv ed in th e m an uf act ur e of Reg la n: Pfi zer, In c.; W y et h, LLC;

Sch wart z Ph arm a, In c.; an d Alav en Ph arm aceu ti c al

, LLC (co ll ect iv el y , “ Bran d

Defend an ts” ). T he seco nd gr ou p of de fen da nt s, co ns is ti ng of PLIVA, In c. (“ PLIVA”)

a n d Mu tu al Ph arm aceu ti cal Co m pa ny (“ Mu tu al ”) (co ll ect iv el y , “ Gen eri c

Defen da nt s” ), m an uf

act ur e ge ne ric ve rs io ns of Reg la n, kn own as m et oc lo pr am id e. 1

M e to cl op ram id e is no t an ex act du pl ic at e of Reg la n, bu t fed eral reg ul at io ns
si gn ifi can tl y co ns tra in it s co nt en ts an d effe ct s. Man uf act ur ers of ge ne ric dr ug s are

r e q u i red

, as a co nd it io n to en te rin g th e m ark et

, to es ta bl is h th at th ei r pr o d u c t i s

“ ch em ic al ly eq ui va le nt ” an d “bio eq ui va le nt ” to th e refe ren ce li st ed dr ug th ey are

rep li cat in g— ge ne ral ly, as he re, th e b r a n d- na m e dr ug

. Mu. Pha rm. Co

. v. Bar tl et t

, 57 0 U.S.
--- (2 01 3)

, 20 13 W L31 55 23 0, at *4 (ci ti ng 21 U .S.C. § 35 5( j)(2) (A)).

Bec au se ge ne ric dr ug s are so si m il ar to th ei r br an d- na m e co un te rp art s, m an y st at es , in cl ud in g Ark an sa s, pe rm it ph arm aci st s to su bs ti tu te ge ne ric dr u g s whe n fil li ng a

pr es cri pt io n fo r a br a n d

- n a me dr ug

. Se e Ark

. Co de Ann

. § 17 -9 2- 50 3. Su ch a
si tu at io n in fact oc cu rred in Fu ll in gt on ’s cas e: al th ou gh h e r p h ysi ci an wro te a

pr es cri pt io n fo r Reg la n, he r ph arm aci st fil le d he r pr es cri pt io n wit h m et oc lo pr am id e.

Fu ll in gt on in it ia ll y fil ed su it ag ai ns t Tev a Ph arm aceu ti cal s USA, In c. as well

, 1

bu t s he vo lu nt ari ly dis m is se d h er cl ai m s wi th pre jud ic e ag ai ns t t hi s d efen da nt

.

-2

-Re gla n an d m et oc lo pr am id e ha ve be en th e su bjec t of ex te ns iv e pr oduc t lia bil ity

li ti ga ti on

. The se su it s ha ve la rg el y be en br ou gh t by in di vi du al s, su ch as Fu ll in gt on , who de ve lo pe d ta rd iv e dysk in es ia a f t e r us in g ei th er or bo th ve rs io ns of th e dr ug

. Si nc e Reg la n an d m et oc lo pr am i d e w e re fir st ap pr ov ed fo r sa le in th e 19 80 s, th e
Uni te d St at es Fo od a n d D r ug Adm in is tra ti on (“ FDA”) ha s oc cas io na ll y req ui red

m an uf act ur ers to up da te th ei r pr od uc t’s la be li ng to refl ect gr eat er un de rs ta nd in g of

th e ris ks of lo n g

- t e r m us e of Reg la n/ m et oc lo pr am id e. Fo r ex am pl e, in 20 04

, th e

FDA req ui red th e ad di ti on of a bo ld ed warn in g st at in g t ha t u se “ sh ou ld no t ex ceed

12 week s in du rat io n.” Fi ve y ears la te r, th e FDA m an da te d th e in cl us io n of a bl ack

bo x warn in g, whi ch cau ti on s th at “ Pro lo ng ed tre at m en t (g reat er th an 12 week s) wit h

m et oc lo pr am id e sh ou ld be av oi de d i n a ll bu t ra re ca se s.”

W he n a m an uf

act ur er ap pl i e s fo r FDA ap pr ov al fo r a ge ne ric dr ug , it “ is

res po ns ib le fo r en su rin g th at it s warn in g la be l is t h e s a m e as th e br an d na m e’s.”

PLIVA, In c. v. Men si ng , 5 6 4 U

. S

. - - - , 13 1 S. Ct

. 25 67

, 25 74 (2 01 1)

. The Su pr em e

Co ur t in Men si ng up he ld th e FDA’s in te rp ret at io n of it s reg ul at io ns as req ui rin g th at

“ th e warn in g la be ls of a br an d- na m e dr ug an d i t s g e n e r i c co py m us t al way s be th e

sa m e—t hu s , g en eri c dr ug m an uf act ur ers ha ve an on go in g fed eral du ty of

‘sam en es s.’” Id

. at 25 74 -7 5 & n.3

. As a res ul t of t h e s e c o n s t rai nt s, a ge ne ric dr ug

man uf act ur er can no t un il at eral ly s tre ng th en th e warn in gs on it s pr od uc t’s la b e l i n g

. Id

. at 25 75

, 25 78

. The Co ur t in Men si ng cl ari fie d th at “i mp o s s i bi li ty” pr eem pt io n

ex is ts whe re a pa rty can no t “ in de pe nd en tl y do un de r fed eral la w w ha t st at e la w

req ui res of it .” Id

. at 25 79

. Acco rd in gl y , to rt su it s se ek in g to im po se li ab il it y ba se d

on a m an uf

act ur er’s fai lu re to st ren gt he n or m od ify a ge ne r i c d r u g ’s la be li ng are

pr eem pt ed by fed eral dr ug reg ul at io ns

. Id

. at 25 76 -8 1. The lo gi cal co ro ll ary of th is

reg ul at or y sc he m e is th at cert ai n de si gn de fect cl ai m s are pr eem pt ed as well

. As th e

Su pr em e Co ur t rece nt ly ex pl ai ne d, be cau se a ge ne ric dr ug m an uf act ur er is pr oh ib it ed

fro m un il at eral ly red es ig ni ng ei th er its pr od uc t’s lab el in g or des ig n, a de si gn de fect

cl ai m th at wou ld im

po se li ab il it y fo r a fai lu re to un de rta ke on e of th es e two co ur se s

of act io n i s si m il arl y pr eem pt ed

. Bar tl et t

, 20 13 W L 31 55 23 0, at * 8- 10 . Mor eo ve r,

-3

-a ge ne ric m an uf act ur er is no t ob li ga te d to le av e th e m ark et whe n i t i s in cap ab le of

co m pl y in g wit h bo th fed eral an d st at e ob li ga ti on s; im po si ng su ch a Hob so n’s ch oi ce

wou ld ren de r i mp os si bi li ty pr eem pt io n “ al l bu t m ean in gl es s.” Id

. at *1 0 (q uo ti ng

Men si ng , 13 1 S . Ct. at 25 79 ).

The li ti ga ti on in th is cas e sp an s a ti m e pe rio d bo th pr io r an d su bs eq ue nt to th e

Co ur t’s de ci si on in Men si ng , an d it in vo ke s th e sc op e of cl ai m s pr eem pt ed pu rs ua nt

to Men si ng an d no w Bar tl et t

. In Sep te m be r 20 10

, th e di st ric t co ur t gr an te d th e Bran d

Defen da nt s’ m o t i o n fo r su m m ary jud gm en t. The Bran d Defen da nt s arg ue d th at

be ca use the y ne ith er m an

uf ac tu red no r di st rib ut ed th e m et oc lo pr am id e th at Fu lli ngt on

in ge st ed

, Fu ll in gt on ’s pr od uc t li ab il it y cl ai m ag ai ns t th em was no t vi ab le un de r

Ark an sa s la w. The di st ric t co ur t ag reed

, in te rp ret in g Ark an sa s la w as req ui rin g th e pl a i n t i ff to m ak e a “ pr od uc t id en ti fic at io n,” in ot he r wor ds “ al le ge th at th e act ua l

pr od uc t m an uf

act ur ed or di st rib ut ed by th e de fen da nt cau se d th e in ju r y t o th e pl ai nt iff .”

W hi le Men si ng was pe nd in g, th e Gen eri c Defen da nt s ob ta in ed a st ay in th es e

pr oc eed in gs

. Afte r th e Su pr em e Co ur t rel eas ed it s op in io n, th e di st ric t co ur t gr an te d

th e Gen eri c Defen da nt s’ m ot io n t o d is m is s. The di st ric t co ur t co nc lu de d t ha t al l o f

Fu ll in gt on ’s cl ai m s ag ai ns t th e Gen eri c Defen da nt s were pr em is ed on “ fai lu re-t o

warn al le ga ti on s” an d, as su ch

, were pr eem pt ed pu rs ua nt to Men si ng be cau se it wou ld

be im po ss i b l e f

o r th e Gen eri c Defen da nt s to co m pl y wit h bo th fed eral dr ug

reg ul at io ns an d th e m or e rig or ou s w a rn in gs reg ard in g lo ng -te rm us e th at Ark an sa s

la w al le ge dl y req ui red

. The di st ric t co ur t al so ru le d, in th e al te rn at iv e, th at to th e

ex t e n t F u ll in gt on pl ed pr od uc t li ab il it y cl ai m s ot he r th an fai lu re to warn , na m el y

m an uf act ur in g or de si gn de fect cl ai m s, he r al le ga ti on s fai le d to m eet fed eral pl ead in g

st an da rd s. Se e Ash cr of

t v. Iq ba l , 55 6 U.S. 6 62 , 67 8 (2 00 9)

.

Fu ll in gt on th en so ug ht an d ob ta in ed le av e to am en d h e r co m pl ai nt

, ci ti ng

PLIVA’s rece nt di sc lo su re th at it ha d fai le d to up da t e t h e la be li ng on th e

-4

-m et oc lo pr am id e it pr od uc ed

, as req ui red by 20 03 an d 20 04 FDA-m an da te d ch an ge s

to Reg la n’s la be li ng

. Fu ll in gt on di d no t am en d he r m is rep res en ta ti on an d im pl ie d

warra nt y cl ai m s, an d th e di st ric t co ur t su bs eq ue nt ly di sm is se d th es e cl ai m s ba se d on

t h e an al y si s in it s in it ia l op in io n. As to Fu ll in gt on ’s ot he r, am en de d cl ai m s, t h e
di st ric t co ur t de te rm in ed th at each was st il l pr em is ed on al le ga ti on s of in ad eq ua te

warn in gs

. The di st ric t co ur t al so co n c l u d ed th at Fu ll in gt on ’s de si gn de fect

al le ga ti on s rem ai ne d to o co nc lu so ry to m eet fed eral pl ead in g st an da rd s. To th e ex te nt

an y of Fu ll in gt on ’s cl ai m s in vo ke d a ne w ch a l l en ge to th e ad eq ua cy of PLIVA’s

warn i n g s , b a s ed on th e fai lu re to up da te it s la be li ng as req ui red by fed eral la w

2
(“ fai lu re t o u pd at e cl ai m ”), t he di st ric t co ur t ru le d th at su ch a cl ai m was n ot vi ab le

. The di st ric t co ur t ack no wled ge d reas on ab le arg um en ts bo th fo r an d ag ai ns t th e

pr op os it io n th at th is cl ai m was pr eem pt ed un de r Men si ng , bu t it el ect ed no t to de ci de

th e is su e. In st ead

, th e di st ric t cou rt di sm is se d th e cl ai m s bas ed on a pe rcei ve d fata l

in te rn al in co ns is te nc y be twee n Fu ll in gt on ’s th e o r y o f li ab il it y an d he r al le ga ti on s

reg ard in g in ad eq ua te warn in gs

. O n o ne ha nd

, Fu ll in gt on cl ai m ed th at th e Reg la n/ m et oc lo pr am id e la be li ng was de fic ie nt un ti l th e ad di ti on of a bl ack bo x

warn in g in Feb ru ary 20 09 ; y et on th e ot he r ha n d sh e fau lt ed PLIVA fo r fai li ng to

in co rp or at e th e 2 0 0 4 l ab el ch an ge , a ve rs io n of la be li ng th at sh e in si st ed was st il l

in ad eq ua te to fu ll y wa r n of th e da ng ers of lo ng -te rm us e. In a m ot io n fo r

reco ns id erat io n, Fu ll in gt on arg ue d th at sh e ha d be en pl ead in g in th e al te rn at i ve , a

co nt en ti on whi ch th e d is tri ct co ur t re jecte d. 3

Fu ll in gt on di d no t al le ge th at Mu tu al fai le d to in co rp or at e th e 20 03 an d 20 04 2

la be l ch an ge s o nt o i ts pro du ct ’s lab el in g.

The di st ric t co ur t de te rm in ed th at ba se d on th e co m pl ai nt al on e, Fu ll in gt on ’s 3

to rt c la im ag ai ns t PLIVA fo r us e o f m et oc lo pr am id e be twee n Feb ru ary 20 09 , when
th e la be li ng su pp os ed ly became ad eq ua te wit h th e ad di ti on of a bl ack bo x warni ng ,
a n d A pr il 20 09

, whe n Fu ll in gt on st op pe d in ge st in g th e dr ug , co ul d su rv iv e. The
di st ric t co ur t co nv ert ed PLIVA’s m ot io n to di sm is s in to a mo t i o n f o r su m m ary jud gm en t an d of

fere d Fu ll in gt on fo ur t e en da y s to pr es en t ev id en ce th at sh e ha d
in ge st ed PLIVA-m an uf

act ur ed m et oc lo pr am id e du rin g th is pe rio d. In he r m ot io n fo r

-5

-Fu ll in gt on ap pe al s th e d is tri ct co ur t’s ad ve rs e g ran t o f su m m ary jud gm en t to

th e Bran d Defen da nt s an d it s di sm is sa l of he r cl ai m s wit h p r e ju d i c e ag ai ns t th e

Gen eri c Defen da nt s.

II . Cla ims Aga in st the Br an d Defen da nts

W e rev ie w de no vo th e di st ric t co ur t’s gr an t of su m m ary jud gm en t to th e Bran d

Defen da nt s. Kn ut

so n v. Sc hw a n ’

s Home Se rv ic e, In c. , 71 1 F.3 d 91 1, 91 3 (8 th Ci r.

20 13 ). Fu ll in gt on st ip ul at ed th at sh e on ly in ge st ed m et oc lo pr am id e; at no po in t di d

sh e in ge st Reg la n or an y ot he r pr od uc t m an uf act ur e d o r di st rib ut ed by on e of th e

Bran d Defen da nt s. N o n et he le ss , Fu ll in gt on in si st s sh e can m ai nt ai n a pr od uc t

li ab il it y sui t ag ai ns t th e Bran d Defen da nt s. Alt ho ug h Fu ll in gt on co nc ed es th at cl ai m s
ba se d on st ric t li ab il it y or br each of warra nt y r e q u i r e a pr od uc t id en ti fic at io n, sh e

in si st s t h a t A r k an sa s la w do es no t req ui re su ch a sh owi ng if th e pl ai nt iff ’s pr od uc t

li ab il it y cl ai m s are ba se d on ne gl ig en ce, m is rep res en ta ti on , su pp res si on of ev id en ce,

or frau d.

The Ark an sa s Pro du c t Liab il it y Act (“ APLA”) de fin es “ pr od uc t li ab il it y

act io n” as “ al l act io ns br ou gh t fo r or on acco un t of pe rs on al in jury, de at h, or pr op ert y
da m ag e cau se d by or res ul ti ng fro m th e m an uf act ur e, co ns tru ct io n, de si gn , fo rm ul a,

pr ep arat io n, as se m

bl y , tes ti ng , ser vi ce, warn in g, i ns tru ct io n, m ark et in g, pack ag in g,

or la be li ng of an y pr od uc t.” Ark

. Co de An n

. § 16 -1 16 -1 02 (5 ). Not on ly do al l of

Fu ll in gt on ’s cl ai m s fal l wit hi n t h e pl ai n m ean in g of th is de fin it io n of “ pr od uc t

li ab il it y act io n,” bu t a rece nt de ci si on by th is co ur t reg ard in g ne arl y id en ti cal ly-pl ed

cl ai m s vi rtu al ly co m

pe ls th e co nc lu si on th at Fu ll in gt on ’s cl ai m s are a l l “ pr od uc t

reco ns id erat io n, Fu ll in gt on co nc ed ed th at sh e co ul d no t do so

. Acco rd in gl y , th e di st ric t co ur t en te red su m

m ary jud gm en t in fav or of PLIVA on Fu ll in gt on ’s su rv iv in g cl ai m th at PLIVA’s warn in gs were in ad eq ua te aft er Feb ru ary 2 0 09

. On ap pe al

, Fu ll in gt on do es no t arg ue th at de fic ie nc ie s in th e warn in gs acco m pa nyin g PLIVA’s

m et oc lo pr am id e fro m

Feb ru ary to Apri l 2 00 9 c au se d h er t ard iv e d y sk in es ia

.

-6

-li ab il it y act io ns ” un de r Ark an sa s la w. Se e Bell v. Pfi ze r, In c. , --- F.3 d ---, 20 13 W L

26 61 18 9, at *3 (8 th Ci r. Ju ne 14

, 20 13 ). As th e co ur t in Bell al so he ld

, Ark an sa s la w

req ui res pr o d u ct id en ti fic at io n fo r al l pr od uc t li ab il it y act io ns , an d th ere is no

in di cat io n “ th e Ark an sa s Su pr em e Co ur t wou ld crea te an ex cep ti on to th e Ark an sa s

pr od uc t id en ti fic a ti on req ui rem en t to al lo w [Fu ll in gt on ] to ho ld th e [B]ran d
[D]efend an ts li ab le fo r in juri es cau se d b y th ei r co m pe ti to r’s ge ne ric pr od uc ts .” Id

.
at *4

. W e are no t at li be rty to co nt rad ic t an ot he r pa ne l’s in te rp ret at io n of se ct io n 16

- 11 6- 10 2( 5)

. Se e, e

. g

. , U ni te d St at es v. Co ll in s , 32 1 F.3 d 69 1, 69 8 & n.5 (8 th Ci r.

20 03 ). Fu ll in gt on ’s c l a i m s ag ai ns t th e Bran d Defen da nt s are al l “ pr od uc t li ab il it y

act io ns ,” so th ey are on ly vi ab le if sh e is ab le to m ak e a pr o d u c t id en ti fic at io n.

Bec au se Fu ll in gt on st ip ul at ed th at sh e ne ve r us ed Reg la n m an uf act ur ed or di st ributed
by an y of th e Bran d Defen da nt s, sh e “ can no t ho ld th em li ab le un de r Ark an sa s la w.” 4

Bell , 2 01 3 W L 2 66 11 89

, at *4

. The di st ric t c o u r t d i d no t err in gr an ti ng th e Bran d

Defen da nt s’ m ot io n fo r su m m ary jud gm en t.

Lik e th e ap pe ll an t in Bell , F ul li ng to n arg ue s fo r th e fir st ti m e o n a pp eal th at 4

if a pr od uc t id en ti fic at io n req ui rem en t do es ap pl y to he r cl ai m s ag ai ns t th e Bran d
Defen da nt s, sh e ha s sa ti sf ie d it be cau se th e Bran d Defen da nt s are “ m an uf act ur ers ”
of ge ne ric m et oc lo pr am id e as th at te rm is de fin ed in th e APLA. Se e Ark

. Co de Ann

. § 16 -1 16 -1 02 (3 ) (“ ‘Manu fact ur er’ m ean s th e de si gn er, fab ric at or , pr od uc er,

co m po un de r, pr oc es so r, or as se m bl er of an y pr od uc t or it s co m po ne nt pa rts .”). Und er th is th eo ry , th e Bran d Defen d a n t s are “ m an uf act ur ers ” of th e m et oc lo pr am id e Fu ll in gt on co ns um ed be cau se th ey de si gn ed th e dr ug up on whi ch th e ge ne ric ve rs io n is ba se d, an d th ey , in co nju nc ti on wit h th e FDA

, d e t e rm in e th e la be li ng ge ne ric

m an uf act ur ers m

us t rep ro du ce on th ei r own pr od uc ts

. Thi s cl ai m c o n t r a d ic ts
Fu ll in gt on ’s st ip ul at io n to th e di st ric t co ur t th at he r “ cau se s of act io n ag ai ns t [th e Bran d Def

en da nt s] a re no t ba se d on an y cl ai m th at [th ey ] man uf ac tu re d or so ld th e Reg la n/ m et oc lo pr am id e in ge s t e d b y Jo y ce Fu ll in gt on .” (Em ph as is ad de d.) W e de cl in e, as th e Bell co ur t di d, to ad dr es s th is no ve l arg um en t fo r th e fir st t i me on
ap pe al be cau se th ere are no “ ex cep ti on al ci rcu m st an ces ” warra nt in g de pa rtu re fro m th e ge ne ral ru le th at “ we can no t co ns id er is su es no t rai se d in th e di st ric t co ur t.” Bell

, 20 13 W L 26 61 18 9, at *3 n.1 (q uo ti ng Sh an kl in v. Fit zg er al d

, 39 7 F.3 d 59 6, 60 1 (8 th
Ci r. 20 05 )).

-7

-II I. Cla ims Aga in st the Ge neri c Defen da nts

“ W e rev ie w de no vo a di st ric t co ur t’s de ci si on to gr an t a mo t i o n t o di sm is s,

acce pt in g th e co m

pl ai nt ’s al le ga ti on s as tru e.” Gomes v. Am. Cen tu ry Co s. , 71 0 F.3 d

81 1, 81 5 (8 th Ci r. 20 13 ). The ou tc om e of th is ap pe al is co nt ro l l e d in la rg e pa rt by

th is co ur t’s recen t deci si on in Bell v. Pfi ze r, Inc

. The ap pe ll an t in th at cas e, Sh irl ey
Bel l, al so de ve lo pe d ta rd iv e dysk in es ia fo ll owi ng pr ol on ge d us e of m et oc lo pr am id e.

Bell

, 20 13 W L 26 61 18 9, at *1

. Li k e Fu ll in gt on , Bel l br ou gh t a pr od uc t li ab il it y

act io n un de r Ark an sa s la w rai si ng cl ai m s ba se d on “ ne gl ig en ce; st ric t liab il it y ; br each

of war r a nt ie s; m is rep res en ta ti on , su pp res si on of ev id en ce, an d frau d; an d gr os s

ne gl ig en ce.” Id

. Th e d is tri ct co ur t al lo wed Bel l to am en d he r co m pl ai nt po st

M en si ng bu t th en di sm is se d he r cl ai m s wit h pr ejud ic e, fin di ng th at th ey r e mai n e d

pr eem pt ed fai lu re-t o- warn cl ai m s an d, to th e ex te nt he r fai lu re to up da te cl ai m ag ai ns t

PLIVA was no t pr eem

pt ed

, it was ba rred by Ark an sa s’s ap pl i c a t i o n of th e le arn ed

in te rm ed ia ry do ct rin e. Id

. at *6

, 8. On ap pe al , th is co ur t “ ag ree[ d] wit h t he di st ric t

co ur t t ha t th e va st m ajor it y of Bel l’s all eg at io ns in he r am en de d c om pl ai nt set for th

pr eem pt ed fai lu re t o w a r n cl ai m s,” wit h th e ex cep ti on of he r “ de si gn de fect an d

br each of im

pl ie d warra nt y cl ai m s, ot he r th an th os e ba se d on an in ad eq ua te warn in g

or la be li ng .” Id

. at *7

. The co ur t in Bell rev ers ed th e di sm is sa l of th es e la tt er cl ai m s
be cau se th e di st ric t cou rt had in co rrec tl y vi ewed th em as pre em pt ed fai lu re t o warn
cl ai m s and ha d no t anal y zed whe th er the se cl ai m s ot he rwis e “ st at e[d ] vi ab le cla im s

un de r Ark an sa s la w.” Id

. Th e co ur t di d no t reac h th e is su e of whe th er th e ho ld in g

in Men si ng pr eem

pt ed a fai lu re to up da te cl ai m , ag reei ng wit h th e di st ric t co ur t th at

su ch a cl ai m was in an y cas e no t vi ab le gi ve n Ark an sa s’s ad h eren ce to th e le arn ed

in te rm ed ia ry

do ct rin e. Id

. at * 8- 9.

Lik e th e am en de d co m

pl ai nt in Bell

, th e va st m ajor it y of t h e a l l e g a ti on s in

Fu ll in gt on ’s am en de d com pl ai nt are pre m is ed on pre em pt ed fai lu re to warn clai m s.
The ex cep ti on , as th is co ur t det erm in ed in Bell , are h er “ no n- warn in g d es ig n d efec t

an d br each of im

pl ie d warra nt y cl ai m s.” Id

. at *7

. Yet th e di st ric t co ur t in th is cas e,

-8

-jus t li ke th e Bell di st ric t co ur t, st il l cat eg or iz ed th es e la tt er cl ai m s as fai lu re-t o- warn

cl ai m s. The la ng ua ge in Fu ll in gt on ’s am en de d co m pl ai nt reg ard in g br eac h of im pl ie d

warra nt y cl a i ms is su bs ta nt ia ll y si m il ar to th e an al og ou s cl ai m s in Bel l’s am en de d

co m pl ai nt

. Co mpa re Fu ll in gt on Co m pl

. ¶¶ 7.0 9- 7.1 2 wi th Bel l Co m pl

. ¶¶ 4.1 0- 4.1 4.

Acco rd in gl y , we rev ers e th e di sm is sa l of Fu ll in gt on ’s no n- warn in g br each of im pl ie d

warra nt y cl ai m s an d rem an d fo r fu rth er co ns id erat io n as to whe th er th ey “ ad eq ua te ly

st at e vi ab le cl ai m s un de r Ark an sa s la w” an d if so , wh et he r th e Gen er ic Defen da nt s

can no ne th el es s es ta bl is h p reem pt io n. Id

. at * 7.

The re is on e no ta bl e di st in ct io n be twee n th is cas e an d Bell

. The di st ric t co ur t

in th is cas e m ad e an al te rn at iv e h o ld in g reco gn iz in g th at

, to th e ex te nt Fu ll in gt on

art ic ul at ed a de si gn de fect cl ai m in de pe nd en t of a fai lu re to warn cl ai m , th e cl ai m di d

no t sa ti sf y fed eral pl ead in g st an da rd s. The di st ric t co ur t la te r de te rm in ed th at

Fu ll in gt on ’s am en de d c om pl ai nt fai le d t o re ct ify the pro bl em

.

“ To su ccee d on a de si gn de fect cl ai m un de r Ark an sa s l a w , t h e pl ai nt iff m us t

es ta bl is h t ha t th e pr od uc t was in a de fect iv e co nd it io n, th at th e d efec ti ve co nd it io n 5

ren de red th e pr oduct unr ea sona bly da nge rous , an d th at th e de fect pr ox im at el y cau se d

6

th e co m pl ai ne d- of in

jury.” Boe rn er v. Bro wn & W il li ams on To ba cco Co

. , 39 4 F.3 d

5 9 4

, 5 9 8 ( 8t h Ci r. 20 05 ). W e di sa gr ee wit h th e di st ric t co ur t’s co nc lu si on th a t

“‘Defect iv e co nd it io n’ means a co nd it io n of a pr od uc t th at ren de rs it un sa f e 5

fo r reas on ab ly fo res eeab le us e an d co ns um pt io n.” Ark

. Co de Ann

. § 16 -1 16 -1 02 (2 ).

“ ‘U nr eas on ab ly da ng ero us ’ m ean s th at a pr od uc t i s da ng ero us to an ex te nt 6

be y on d th at whi ch wou ld be co nt em pl at ed by th e or di na ry an d reas on ab le bu y er,

co ns um er, or us er who acq ui res o r u se s th e pr od uc t, as su m in g th e or di na ry kn owl ed ge of th e c o mm un it y or of si m il ar bu y ers , us ers , or co ns um ers as to it s ch arac te ris ti cs , pr op en si ti es , ris ks

, da ng ers , an d pr op er an d im pr op er us es , as well as

an y sp eci al kn owl ed ge , tra in in g, or ex pe rie nc e po ss es se d by th e pa rt i c u l a r bu y er,

us er, or co ns um er or whi ch he or sh e was req ui red to po ss es s.” Ark

. Co de Ann

. § 16

- 11 6- 10 2( 7) (A).

-9

-Fu ll in gt on ’s d e s ig n de fect al le ga ti on s were to o co nc lu so ry to su rv iv e a m ot io n to

di sm is s be cau se he r co m

pl ai nt in cl ud es “ su ffi ci en t fa ct ua l m at te r, acce pt ed as tru e,

t o s t a t e a cl ai m fo r rel ie f th at is pl au si bl e on it s face .” Hami lt on v. Pal m , 6 21 F.3 d

81 6, 81 7 (8 th Ci r. 20 10 ) (q uo ti ng Asch cr of t v. Iq ba l

, 55 6 U.S. 6 6 2

, 6 78 (2 00 9) ).

Fu rth erm or e, to th e ex te nt th e di st ric t co ur t fo un d Fu ll in gt on ’s c la im s in su ffi ci en t

be cau se sh e fai le d to su bm it “ fact ua l al le ga ti on s th at PLIVA or Mu tu al

, as op po se d

to th e br an d- na m e m an uf act ur ers , act ua ll y de si gn ed m et oc lo pr am id e,” su ch an

al le ga ti on is un ne ces sa ry un de r Ark an sa s la w. Se e Boe rn er v. Bro wn & W il li ams on

To ba cco Co rp

. , 26 0 F.3 d 83 7

, 84 1 (8 th Ci r. 20 01 ) (ex pl ai ni ng th at Ark an sa s la w

au th or iz es st ric t li ab il it y cl ai m s ag ai ns t th e “ su pp li er of a pr od uc t” who “ is en ga ge d

in th e bu si ne ss of m an uf

act ur in g

. . . or ot he rwis e di st rib ut in g th e pr od uc t.” (q uo ti ng

Ark . Cod e Ann . § 4 -8 6- 10 2( a)))

.

Non et he le ss , th e Su pr em e Co ur t’s rece nt de ci si on in Bar tl et t cas ts do ub t on th e
vi ab il it y of Fu ll in gt on ’s de si gn de fect cl ai m

. In Bar tl et t

, th e Su pr em e Co ur t he ld th at

th e pl ai nt iff ’s de si gn de fect cl ai m , br ou gh t un de r New Ham ps hi re la w, was

pr eem pt ed

. Bar tl et t

, 20 13 W L 31 55 23 0, at *1 0. An “ un reas on ab ly da ng ero us ”

pr od uc t is an el e men t o f a de si gn de fect cl ai m un de r bo th New Ham ps hi re an d

Ark an sa s st at e la w. New Ham ps hi re st at e co ur ts us e a “ ris k- ut il it y ap pr oa ch ” to

d e t e r mi ni ng whe th er a pr od uc t is un reas on ab ly da ng ero us

. Id

. at *8

. Und er th i s

ap pr oa ch

, N ew H am

ps hi re co ur ts te nd to ba la nc e th ree fact or s in de te rm in in g whe th er

th e de fen da nt su pp li ed an un reas on ab ly da ng ero us pr od uc t: th e pr od uc t’s va lu e to th e

pu bl ic

, whe th er th e su pp li er co ul d red uc e th e pr od uc t’s ris ks wit ho ut m ajor ex pe ns e

or se rio us de tri m en t to th e pr od uc t’s effi cacy, an d whe th er an al te rn at e warn in g co ul d

m it ig at e un reas on ab le ris k of ha rm “ fro m hi dd en da ng ers or fro m fo res eeab le us es .”

Id

. (q uo ti ng Vau to ur v. Bod y Mas te rs Sp or ts In du s., In c. , 78 4 A.2d 11 78

, 11 81 (N.H.

20 01 )). The fir st two fact or s, th e Co ur t de te rm in ed

, ne ces sa ril y req ui red ge ne ric dr ug

m an uf act ur ers un il at eral ly to red es ig n th e co m po si ti on of th ei r dr ug s, whi ch fed eral

la w pr ecl ud es ge ne r i c d r u g man uf act ur ers fro m do in g. Id

. As a res ul t, th e on ly

rem ai ni ng m ech an is m by wh ic h a ge ne ric dr ug m an uf act ur er co ul d “ am el io rat e th e

-1 0-dr ug ’s ‘risk -u ti li ty’ pr of il e—a nd th us

. . . es cap e li ab il it y —was to st ren gt he n” th e
dr ug ’s warn in g la be l. Id

. at *9

. As Men si ng pr ev io us ly es ta bl is he d, th is

, to o, ge ne ric

dr ug m an uf

act ur ers can no t in de pe nd en tl y do un de r fed eral l a w

. The de fen da nt

ge ne ric dr

ug m an uf act ur er in Bar tl et t

, no le ss th an in Men si ng , was cau gh t be twee n

th e d ev il an d t he de ep bl ue sea : t he on ly w ay to av oi d st at e-l aw to rt li ab il it y was to

ta ke act io ns for

bi dd en by feder al law.

In co nt ras t to New Ham

ps hi re’s r i s k

- u t il it y ap pr oa ch

, Ark an sa s st at e co ur ts

f oc us on co ns um er ex pe ct at io ns in de te rm in in g whe th er a pr od uc t is un re a s o n a b l y
da n g e r ou s. Se e Ark

. Co de Ann

. § 16 -1 16 -1 02 (7 )(A) (d efi ni ng “ un reas on ab ly

da ng ero us ” in te rm s of th e ex pe ct at io ns of “ th e or di na ry an d reas on ab le bu y er”) ;

Pur in a Mil ls , I

nc . v . As ki ns , 87 5 S.W .2d 84 3, 84 7 (Ark . 1 99 4) ; Berk el ey Pump Co

.

v. Reed -Jo se ph La nd Co

. , 65 3 S.W .2d 12 8, 13 3 (Ark

. 19 83 ). Co ns eq ue nt ly, it is no t

im m ed ia te ly cl ear whe th er Ark an sa s, un li ke New Ham ps hi re, of fers ge n e ric dr ug

m an uf act ur ers an op po rtu ni ty, co ns is te nt wit h fed eral ob li ga ti on s, to so m eh ow al te r

an ot he rwis e un reas on ab ly d an ge ro us dr ug

. The refo re, we rev ers e th e di sm is sa l of

Fu ll in gt on ’s de si gn de fect al le ga ti on s an d rem an d to th e di st r i c t c ou rt fo r fu rth er

co ns id erat io n i n l ig ht of Bar tl et t

. Se e Bel l , 20 13 W L 26 61 18 9, at *6 n.2

.

The on ly cl ai m le ft to be co ns id ered is Fu ll in gt on ’s fai lu re to up da te cl ai m

. The

co ur t in Bell di d no t reac h th e qu es ti on of whe th e r B el l’s an al og ou s cl ai m was

pr eem pt ed un de r Men si ng be cau se th e c o ur t co nc lu de d it was no t vi ab le du e to

Ark an sa s’s le arn ed in te rm ed ia ry do ct rin e. Und er th is do ct rin e, “ a dr ug m an uf act ur er

m ay rel y on th e p res cri bi ng ph y si ci an to warn th e u lt im at e co ns um er o f th e ri sk s o f

a pr es cri pt io n dr

ug .” W es t v. Se ar le & Co

. , 80 6 S.W .2 d 6 0 8, 61 3 (Ark

. 19 91 ). A

m an uf act ur er’s in ad eq ua te warn in g is no t a pr ox im at e cau se of a pl ai nt iff ’s ha rm so

l o n g a s th e pr es cri bi ng ph y si ci an ha d in de pe nd en t kn owl ed ge of th e ris k th at t h e

in a d eq ua te warn in g sh ou ld ha ve co m m un ic at ed

. Bell

, 20 13 W L 26 61 18 9, at *8

. Bel l’s ph y si ci an , li ke Fu ll in gt on ’s, wro te a pr es cri pt io n fo r th e refe ren ce li st ed dr ug , Reg la n, whi ch a ph arm aci st th en fil le d wit h m et oc lo pr am id e. Bel l ad m it te d th at he r

-1 1-pr es cri bi ng ph y si ci an rel ie d on in fo rm at io n pr o v i d ed by th e m an uf act ur er of th e

refe ren ce li st ed dr ug , whi ch in cl ud ed th e up da te d warn in g. A s a r e s ul t, Bel l’s

pr es cri bi ng ph y si ci a n ha d in de pe nd en t kn owl ed ge of th e ris k th e up da te d

m et oc lo pr am id e la be l wo ul d hav e co m m un ic at ed

, an d so th is co ur t d et erm in ed th at

Bel l fai le d to art ic ul at e a cau sa l li nk be twee n he r in jury an d PLIVA’s fai lu re to

up da te it s la be li ng

. Id

. at *9

. Fu ll in gt on al so ad m it s th at “ he r pr es cri bi ng do ct or
rel ie d up on in fo rm at io n pu bl is he d in th e pa ck ag e in se rts an d/ or th e Ph y si ci an s’ Des k

Refe ren ce

. . . o r ot he rwis e d i s se m in at ed by t he Refe ren ce Lis te d Dru g Co m pa ny.”

Ark an sa s’s le arn ed in te rm ed ia ry do ct rin e ap pl ie s, th en , jus t as it di d in Bell

. Alt ho ug h th e di st ric t co ur t rel ie d on al te rn at iv e reas on in g, we can “ affi rm th e di st ric t

co ur t’s d is m is sa l o n a ny bas is su pp or te d b y th e rec or d.” Phi

pp s v. FDIC , 4 17 F.3 d

10 06

, 10 10 (8 th Ci r. 20 05 ). Acco rd in gl y , we affi rm th e di st ric t co ur t’s di sm is sa l of

Fu ll in gt on ’s cla im s ag ai ns t PLIVA fo r fai li ng to up da te it s l ab el in g.

II I. Co ncl us io n

Fo r th e fo reg oi ng reas on s, we affi rm th e gr an t of su m m ary jud gm en t in fav or

of th e Bran d Defen da nt s. W it h res pe ct to th e cl ai m s ag ai ns t th e Gen eri c Defen da nt s,

we affi rm th e di sm is s a l o f Fu ll in gt on ’s f ai lu re to warn an d fai lu re to up da te cl ai m s

an d rev ers e th e di sm is sa l o f F ul li ng to n’s no n- warn in g de si gn de fect an d br each of

im pl ie d war ran ty clai m s an d re m an d fo r fu rth er p ro ceed in gs

.

MURP HY, Circ ui t J ud ge , con cu rri ng

.

I ag ree wit h th e m ajor it y th at th is cas e is co nt ro ll ed by ou r pr ev io us op in io n in

Bel l v. Pf i z e r , In c., 20 13 U.S. App

. LEXIS 12 00 2 (8 th Ci r. Ju ne 14

, 20 13 ). I al so

ag ree th at we can no t co ns id er Fu ll in gt on 's arg um en t th at th e br an d m an uf act ur ers

were "d es ig ne rs " of th e ge ne ric dr ug be cau s e i t w as no t rai se d in th e di st ric t co ur t.

Se e Dob ro vo ln y v. Mo or e, 12 6 F.3 d 11 11

, 11 14 n.2 (8 th Ci r. 19 97 ). If pr op erl y

-1 2-pr es en te d, h owe ve r, su ch a cl ai m m ay ha ve m eri t gi ve n rece nt de ve lo pm en ts in th e

Su pr em e Co ur t's pre sc rip ti on dru g l ia bi li ty j ur is pr ud en ce.

The ov erwh el m in g m ajor it y o f c o u r t s whi ch ha ve co ns id ered whe th er br an d

m an uf act ur ers co ul d be h e l d li ab le fo r ha rm s cau se d by th ei r ge ne ric co un te rp art s
ha ve an swe red in th e ne g a t i v e

. The se cas es ha ve ge ne ral ly be en pr ed ic at ed on th e

as su m pt io n th at th e ge ne ric m an uf act ur ers co ul d in de pe nd en tl y sa feg ua rd an d

st ren gt he n th ei r own la be ls

. See, e.g ., Fo st er v. Am

. Hom e Pro ds

. Co rp ., 29 F.3 d 16 5,

17 0 (4 th Ci r. 19 94 ); Men si ng v. W y et h, In c., 58 8 F.3 d 60 3, 61 2– 14 (8 th Ci r. 20 09 ),

rev 'd in pa rt on ot he r g r o u n d s s u b no m

. Pl iv a, In c. v. Men si ng , 13 1 S. Ct

. 25 67 (2 01 1)

. Si nc e th e br an d an d ge ne ric m an uf act ur ers were as su m ed to ha v e s e p a r a te

du ti es to en su re th ei r la be ls an d warn in gs were ad eq ua te

, th ere was no reas on fo r th e
br an d m an uf

act ur ers to fo res ee th at ge ne ric co ns um ers wou ld rel y on rep res en ta ti on s

m ad e o n t he bra nd dru g's lab el

. Fo st er, 29 F.3d at 17 0. Co ns eq ue nt ly we ob se rv ed

in Men si ng th at th e br an d m an uf act ur ers di d no t owe a du ty of ca r e t o ge ne ric

cu st om ers be cau se th es e m an uf act ur ers "i nt en de d t o co m m un ic at e wit h th ei r

cu st om ers , no t t he cu st om ers of t he ir c om pe ti to rs ." 5 88 F.3d at 6 13 n.9

.

The Su pr em e Co ur t's de ci si on s in Men si ng an d Mu tu al Ph arm aceu ti cal Co

. v.

Bart le tt

, 20 13 U.S. LEXIS 47 02 (J un e 2 4, 2 01 3) , sev erel y ero de d th e fo un da ti on of

th is an al y si s. The se cas es st rip pe d an y di sc ret io na ry a u t h o r i ty fro m th e ge ne ric

m an uf act ur ers to en su re th e sa fet y of t he ir p ro du ct s o r th e ad eq ua cy of th ei r la be ls

, in st ead pl aci ng th e bu rd en en ti rel y on th e br an d m an uf act u r ers

. See Men si ng , 13 1

S. Ct

. at 25 74

. The pr iv il eg ed po si ti on acco rd ed to th e br an d m an uf act ur ers m ay al te r
th ei r st at e la w rel at io ns hi p to th e ge ne ric dr ug s who se co m po si ti on an d la be li ng th ey

co nt ro l, si nc e at th is po in t su ch a m an uf act ur er is "t he pa rty th at act ua ll y co nt ro ls th e

m an uf act ur in g a n d la be li ng of th e pr od uc t in qu es ti on ." Fi el ds v. W y et h, In c., 61 3

F. Su pp

. 2d 10 56

, 10 61 (W. D. Ark

. 20 09 ). Wi t h th e br an d m an uf act ur ers so le ly

res po ns ib l e f

o r th e co nt en t an d up da ti ng of a ge ne ric 's la be ls

, it can no lo ng er be

-1 3-cred ib ly arg ue d th at co m m un ic at io ns reg ard in g th e ris ks of th ei r pr od uc t are no t al so
di rect ed at c on su m ers of t he ge ne ric bi oe qu iv al en ts

. 7

W it h t he se ob se rv at io ns , I join in th e m ajor it y op in io n.

__ __ __ __ __ __ __ __ __ __ __ __ __ __ __

Tha t is pa rti cu la rly ap pa ren t in th i s c a s e , as Fu ll in gt on 's do ct or pr es cri be d 7 Reg la n, whi ch was th en su bs ti tu te d wit h ge ne ric m et oc lo pr am id e by he r ph arm aci st

.

-1 4-