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

For the Eig hth Circu it

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

No. 1 3- 13 50

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

Tim ot hy Boeh m

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

ff - App el la nt

v.

Eli Lil ly & Com

pa ny

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

an t - Ap pe ll ee

__ __ __ __ __ __
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: Sep te m

be r 26 , 20 13
Fil ed : M arch 10 , 20 14

__ __ __ __ __ __

Befo re LOKEN, COLLO TON, and BENTON, Circu it Ju dg es

.

__ __ __ __ __ __

LOKEN, Ci rcu it Ju dg e.

Zy pr ex a (act iv e in gr ed ie nt ol an zap in e) is an “ at y pi cal ” or “ se co nd ge ne rat io n”

an ti ps y ch ot ic dr ug m an uf act ur ed an d so ld by Eli Lil ly & Co m pa ny (“ Lil ly”).

Tim ot hy Bo eh m ’s do ct or s pr es cri be d Zy pr ex a to tre at hi s bi po la r di so r d e r f r om

Ja nu ary 20 03 u n t i l Mar ch 20 07

, whe n he de ve lo pe d sym pt om s la te r di ag no se d as

ta rd iv e dysk in es i a ( “TD ” )
-- an in vo lu nt ary m ov em en t di so rd er lo ng reco gn iz ed asa s i d e effe ct of an ti ps y ch ot ic dr ug s. Bo eh m br ou gh t th is act io n, la te r rem ov ed b y

Lil ly, as se rti ng pe rs on al in jury an d pr od uc t li ab il it y cl ai m s. The di s tri ct co ur t 1

gr an te d su m

m ary jud gm en t di sm is si ng th e fai lu re-t o- warn cl ai m , ap pl y in g th e

A rkan sa s le arn ed in te rm ed ia ry do ct rin e an d co nc lu di ng th at Lil ly ad eq ua te ly warn ed 2

Bo eh m ’s tre at in g an d pr es cri bi ng ph y si ci an s of th e ris k of de ve lo pi ng m ov em en t

di so rd e r s li ke TD. Afte r Bo eh m di sm is se d hi s rem ai ni ng cl ai m s, th e di st ric t co ur t 3

en te red fin a l ju dg m en t di sm is si ng th e co m pl ai nt

. Bo eh m ap pe al s th e su m m ary jud gm en t or de r, i nc lu di ng th e di st ric t co ur t’s de ci si on to ex cl ud e ex pe rt te st im on y

th at fif te en pe rcen t of Zy

pr ex a us ers wil l de ve lo p TD aft er th ree y ears of us e.

Rev ie win g th e ex cl us io n of exp ert ev id en ce for abu se of di sc ret io n and th e gr an t of

su m m ary jud gm en t de no vo , we affi rm

.

I.

The te st im on y an d m ed ic al reco rd s of two ph y si ci an s who pr es cri be d Zy pr ex a

to tre at Bo eh m ’s bi po la r di so rd er ar e r e l e va nt to th e su m m ary jud gm en t is su es on

ap pe al

. Dr. Fo rres t Mi ll er, a ge ne ral pr act it io ne r, fir st pr es cri be d Zy pr ex a in Ja nu ary

20 03 , wh en Bo eh m

co m pl ai ne d o f sl eep pro bl em s, o ve rwh el m in g an xi et y , a raci ng

m in d, an d de pr es si on

. Dr. Mi ll er’s no te s reco rd th at Bo eh m ha d be en ta ki ng li th iu m , bu t it was no t effe ct iv el y co nt ro ll in g th es e sym pt om s an d was rel at iv el y un sa fe fo r

The Hon or ab le D.P. Mar sh al l, Jr

., Uni te d St at es Dis tri ct Ju dg e fo r th e East ern 1

Dis tri ct of Ark an sa s.

“ Thi s do ct rin e pr ov id es th at a dr ug m an uf act ur er m ay rel y on th e pr es cri bi ng 2 ph y si ci an to warn th e ul ti m at e co ns um er of t h e ris ks of a pr es cri pt io n dr ug

. The ph y si ci an act s as th e ‘learn ed in te rm ed ia ry ’ be twee n th e m an uf act ur e r an d th e ul ti m at e co ns um er.” West v. Se arl e & Co ., 80 6 S .W .2d 60 8, 6 13 (Ark . 19 91 ).

The di st ric t co ur t di sm is se d two cl ai m s wit ho ut pr ejud ic e. At or al arg um en t, 3

Bo eh m ag reed to acce pt di sm is sa l of th os e c l a i ms w it h pr ejud ic e to en su re th at we ha ve a fi na l o rd er t o re vi ew.

-2

-a pa ti en t li ke Bo e h m w h o was no t m on it or ed reg ul arl y

. Dr. Mi ll er pr es cri be d

Zy pr ex a an d an an ti de pr es sa nt

. In th e fo ll owi ng m on th s, Dr. Mi ll er no te d th at Bo eh m

ga i n e d w ei gh t (a co m

m on Zy pr ex a si de effe ct ). Bu t Bo eh m li ke d Zy pr ex a m uc h

be tt er th an li th iu m , an d hi s bi po la r di so rd er was do in g “ ex tre m el y well .” Dr. Mi ll er

te st ifi ed th at he pl an ne d t o c o nt in ue pr es cri bi ng Zy pr ex a to Bo eh m “ un ti l it qu it s

wor ki ng .” Th o u g h Bo eh m sa w Dr. Mi ll er on ly sp or ad ic al ly, ph arm acy an d cl in ic

r e c o r ds sh ow th at Dr. Mi ll er refi ll ed Zy pr ex a pr es cri pt io ns an d pr ov id ed B o e h m Zy pr ex a sa m

pl es th ro ug h J un e 3 0, 2 00 6.

In Aug us t 20 06

, Dr. Greg or y Kacze ns ki

, a ps y ch ia tri st

, be ga n tre at in g Bo eh m

whe n he was ho sp it al iz ed fo r in crea se d de pr es si on an d irr it ab il it y

. Afte r Bo eh m ’s

di sc ha rg e, Dr. Kacze ns ki co nt in ue d pr es cri bi ng Zy pr ex a un ti l lat e Aug us t, when he

pr es cri be d a di ffer en t se co nd -g en erat io n an ti ps y ch o t ic

, Geo do n, be cau se Bo eh m

was n’t sl eep in g well an d hi s ap pe ti te ha d in crea se d. Dr. Kacze ns ki ag ai n pr es cri be d
Zy pr ex a in Octo be r whe n Boe hm rep or te d th at he pr efer red Zy pr ex a to Geo do n. In

Mar ch 20 07

, Dr. Kacze ns ki no te d th at Bo eh m ha d “ so m e di ffi cu lt y wit h art ic ul at io n”

an d “ a rep et it iv e m ov em en t of hi s ne ck

, pu ll in g hi s he ad to ward s th e le ft sh ou ld er.”

Su sp ect in g ei th er d yst on ia or TD, Dr. Kacze ns ki st op pe d pr es cri bi ng Zy pr ex a

b e c a u s e it was th e m os t li ke ly cau se of th es e in vo lu nt ary m ov em en ts

. Ano th e r ph y si c i a n su bs eq ue nt ly di ag no se d Bo eh m as su ffer in g fro m TD cau se d by

an ti ps y ch ot ic dru g u se . Boe hm als o c la im s t o h av e to rti co ll is , a type o f dyst on ia

. 4

Dr. Mi ll er an d Dr. Kacze ns ki te st ifi ed th at th ey were well aware of t h e r i s ks

an d be ne fit s of an ti ps y ch ot ic s. Dr

. Mi ll er be cam e fam il ia r wit h th e si de effe ct s of

ol de r, “ fir st -g en erat io n” an ti ps y ch ot ic s, i n c l u di ng m ov em en t di so rd ers , whe n he

at te nd ed m ed ic al sc ho ol acro ss th e st reet fro m a st at e ho sp it al an d ob se rv ed pa ti en ts

TD in vo lv es rep et it i v e i n vo lu nt ary m us cl e m ov em en ts

. Dy st on ia in vo lv es 4

in vo lu nt ary su st ai ne d m

us cl e co nt ract io ns

. Tort ic ol li s is a type of dysto ni a th at
in vo lv es twi st in g of th e ne ck m us cl es

. Bo eh m al le ge s th at pa in fu l in vo lu nt ary ne ck

twi st in g m ot io ns m ak e h im un ab le to work an d c au se m en ta l an gu is h.

-3

-who su ffer ed fro m th es e si de effe ct s. Dr. Kac z e n s k i ’s ex pe rie nc e wit h th e si de

effe ct s of fir st -g en erat io n an ti ps y ch ot ic s be ga n wit h hi s res id en cy at a st at e ho sp it al

, whe re it was “ ve ry , ve ry co m m on ” to se e pa ti en ts su ffer in g fro m m ov em en t disorde rs

. Bec au se of th es e si de effe ct s, Dr. Mi ll er do es no t p r e s c r i be fir st -g en erat io n

a nt ip sycho ti cs , an d Dr. Kacze ns ki av oi ds pr es cri bi ng th em

. Bo th do ct or s i n s t e a d

pr es cr ib e at y

pi cal se co nd ge ne rat io n an ti ps y ch ot ic s li ke Zy pr ex a. In th ei r ex pe ri en ce , th es e ne wer dr ug s are effe ct iv e in tre at in g se rio us ps y ch ia tri c di se a s e s , s u ch as

sc hi zo ph ren ia an d bi po la r di so rd er; whi le th ey can cau se th e sa m e m ov em en t

di so rd ers as th e fir st ge ne rat io n dr ug s, th ey do so m uc h le ss freq ue nt ly. Bo th do ct or s

co nt in ue to pre sc rib e Zy

pr ex a.

Si nc e Zy pr ex a fir st cam e on th e m ark et

, Lil ly’ s FDA-ap pr ov ed pa ck ag e in se rt

ha s ex pr es sl y

warn ed ab ou t t he ris k o f de ve lo pi ng TD:

Ta rd iv e Dys ki ne si a -- A synd ro m e of po te nt ia l l y irr ev ers ib le

, in vo lu nt ary, dysk in et ic m ov em en ts m ay de ve lo p in pa ti en ts tre at ed wit h

an ti ps y ch ot ic dr ug s.

. . . W he th er an ti ps y ch ot ic dr ug pr od uc ts di ffer in
th ei r po te nt ia l t o c au se tar di ve dyski ne si a is un kn own

.

The ris k of de ve lo pi ng ta rd iv e dysk in es ia an d th e li ke li ho od th at it

w i l l be co m e irr ev ers ib le are be li ev ed to in crea se as th e du rat io n o f

tre a tm en t an d th e to ta l cu m ul at iv e do se of an ti ps y ch ot ic dr ug s ad m in is te red to th e p at ie nt in crea se

. . . .

The re is no kn own tre at m en t fo r es t a b l i s h ed cas es of ta rd iv e dysk in es ia

, al th ou gh th e synd ro m e m ay rem it

, pa rti al ly or co m pl et el y , if a nt ip sycho ti c tr eat m en t i s wi th dr awn

. . . .

Giv en th es e co ns id erat io ns , ol an zap in e sh ou ld be pr es c r i b e d in a

m an ne r th at is m os t li ke ly to m in im iz e th e o c c ur ren ce of ta rd iv e dysk in es i a.

. . . In pa ti en ts who do req ui re ch ro ni c tre at m en t, th e

s mal le st do se an d th e sh or te st du rat io n of tre at m en t pr od uc in g a

sa ti sf act or y cl in ic al res po ns e sh ou ld be so ug ht

. The ne ed fo r co nt in ue d

tre at m en t s ho ul d b e rea ss es se d p eri od ic al ly.

-4

-If si gn s an d sym pt om s of ta rd iv e dysk in es ia ap pe ar in a pa ti en t on ol an zap in e, dr ug di sc on ti nu at io n sh ou ld be co ns id ered

. Howev er, so m e

pa ti en ts m ay

req ui re treat m en t with ol an zap in e de sp it e th e pr es en ce of
th e synd ro m e.

(Em ph as is ad de d.) The pa ck ag e in se rt al so no te s: “ The re is no b o d y o f ev id en ce

av ai la bl e fro m co nt ro ll ed tri al s to gu id e” m ai nt en an ce treat m en t of bip ol ar dis or de r

wit h Zyprex a, m ean in g t reat m en t fo r lo ng er t ha n a m on th

. 5

Dr. Mi ll er te st ifi ed th at h i s p r a c t i c e is to read a dr ug ’s pa ck ag e in se rt be fo re

ev er pr es cri bi ng it

, an d to re-r ead th e in se rt oc cas io na ll y to refr es h hi s m em or y

. Dr.

Kacze ns ki co ns ul ts th e Ph y si ci an s’ De sk Refe ren ce, whi ch co nt ai ns pa ck ag e in se rt

in fo rm at io n, an d re-r e a d s pa ck ag e in se rts whe n th ey are up da te d. Dr. Kacze ns ki

te st ifi ed th at Lil ly’ s pa ck ag e in se rt was ad eq ua te to warn hi m of th e ris k of TD wit h
Zy pr ex a us e. In de pe nd en t of th e pa ck ag e in se rt, Dr. Mi ll er a n d Dr. Kacze ns ki

le arn ed ab ou t Zy

pr ex a’s si de effe ct s fro m th ei r own cl in ic al ex pe rie nc e an d fro m

sp eak in g wit h th ei r co ll eag ue s. Bo th do ct o r s t e s t ifi ed th at an al te rn at iv e warn in g

ab ou t th e ris k of m ov em en t di so rd ers wou ld no t ha ve ch an ge d t h e i r d eci si on s to

pr es cri be Zy

pr ex a to tre at Bo eh m ’s bi po la r di so rd er.

Bas ed on th e ex pr es s TD warn in g it ga ve al l ph y si ci an s, and th e te st im on y of

Bo eh m ’s pr es cr ibi ng ph y si ci an s th at th ey read th e warn in g an d co ns id ered it ad eq ua te

in de ci di ng to pr es cri be Zy pr ex a, Lil ly m ov ed for

pa rti al su m

m ary jud gm en t o n t he

fai lu re-t o- warn cla im , rel y in g o n t he lea rn ed in te rm ed ia ry do ct rin e.

The pa ck ag e in se rt al so r ep or te d th at th e in ci de nc e of dysto ni a (in cl ud in g 5

to rti co ll is ) in a Zy

pr ex a cl in ic al tri al was no t si gn ifi can tl y hi gh er th an wit h a pl aceb o. On ap pe al

, Bo eh m as se rts th at th is was far sh or t of an adeq ua te warn in g. W e ag ree wit h th e d is tri ct co ur t th at “ Bo eh m ha s no t pr od uc ed an y rel ia bl e ev id en ce to sh ow

an in crea se d ris k of to rti co ll is an d dysto ni a as so ci at ed wit h Zy pr ex a [an d th eref

or e]
ha s n ot de m on st rat ed th e n eed for a warn in g.”

-5

-II

.

In op po si ng su m

m ary jud gm en t, Bo eh m arg ue d th at Lil ly fai le d to ad eq ua te ly

warn ph y si ci an s of th e ris k of de ve lo pi ng TD aft er lo ng -te rm us e of Zy pr ex a. Bo eh m

fo cu se d o n a dd it io na l dep os it io n tes ti m on y by Dr. Mi ll er and Dr. Kaczen sk i. Aft er

Dr. Kacze ns ki de sc rib ed weig ht ga in an d m ov em en t di so rd ers as two si de effe ct s th at

can oc cu r wit h l on g- te rm Zy pr ex a u se , he was ask ed :

[Bo eh m ’s co un s e l ]: I ’m go in g to as k y ou ab ou t so m et hi ng th at -- a fig ur e th at I ha ve se en he re, tha t 15 pe rcen t -- an d I will as k y ou if y ou

are aware of th is

. Bu t 15 pe rcen t of th os e who ha ve ta ke n ne ur ol ep ti cs ,
su ch as Zyprex a, fo r th ree years, d ev el op tar di ve dyski ne si a?

[Dr. Kacze ns ki ]: Yes, t ha t’s a n um be r I h av e k no wn fo r a l on g t im e.

Co un se l us ed th at an swe r in cro ss -ex am in in g Dr. Mi ll er at hi s su bs eq ue nt de po si ti on :

[Bo eh m ’s Co un se l]: Did y ou rece iv e an y in fo rm at io n th at on ce a pa ti en t is pr es cri be d Zyp r e x a fo r th ree y ears , on e in si x pa ti en ts wil l de ve lo p

ta rd iv e d y sk in es ia ? W ere you to ld th at ?

* * * * *

[Dr. Mi ll er]: No.

Q: All rig ht

. If y ou ha d kn own t h a t

, a n d th at is an es ta bl is he d fact in
th is cas e p ur su an t t o Do ct or Kacze ns ki ’s d ep os it io n te st im on y * * * --
th at th e in ci de n[ ce] of ta rd iv e dysk in es ia in crea se s to on e in si x pa ti en ts aft er th ree y ears of us e, wou ld y ou st il l ha ve pr es cri be d th a t t o Tim

Bo eh m ?

* * * * *

A: No t fo r th at lo ng

.

-6

-Q: Al l ri gh t. Tha t’s jus t t oo lo ng , is n’t i t?

A: Th at ’s to o l on g.

To sa ti sf y it s du ty t o war n , t h e man uf act ur er of an “ un av oi da bl y un sa fe” bu t

be ne fic ia l pr es cri pt io n dr ug m us t m ak e “ an ad eq ua te warn in g” to pr es cri bi ng ph y si ci an s of th e ris ks of a d v ers e si de effe ct s. W es t, 80 6 S.W .2d at 61 3, ap pl y in g

co m m en t k to § 40 2A of th e Res ta te m en t (Sec on d) of Tort s an d th e l earn ed

i n t erm ed ia ry do ct rin e. Afte r in it ia l br ie fin g, th e di st ric t co ur t co nc lu de d “ th at th is

te st im on y [b y Dr. Mi ll er], if su pp or te d, co ul d crea te a tri ab l e i s s u e ” a s to th e

ad eq ua cy of Lil ly’ s TD warn in g. Bu t th e co ur t no te d th at “ Dr. Kacze ns ki di d no t

of fer th e 15 % ris k fig ur e on hi s own ; th e pe rcen ta ge was pa rt of a le ad in g qu es ti on .”

Acco rd in gl y , th e co ur t “ req ue st ed br ie fin g on whe th er

. . . th e al le ge d 15 % ris k was

su pp or te d by [s ci en ti fic ] ev id en ce th at wou ld be ad m is si bl e un de r D au be rt [v

. Mer rel l

Dow Ph arm aceu ti cal s, In c., 50 9 U.S. 5 79 (19 93 )].”

In res po ns e, Bo eh m rel ie d on th e op in io n of hi s ex pe rt, ps y ch ia tri st Dr. St efan

Kru sz ews ki

. Bas ed on “ cl in ic al ex pe rie nc e an d re v i e w o f rel ev an t li te rat ur e,” Dr.

Kru sz ews k i o p in ed th at “ Zy pr ex a is cap ab le of a hi gh rat e of in ci de nt ta rd iv e dysk in es ia /d y st on ia aft er th ree y ears of us e, affe ct in g be twee n 15

- 2 0 % of th os e

p r e s c r i b e d th e dr ug .” W he n Lil ly ch al le ng ed th at op in io n as la ck in g sc ie nt ifi c

su pp or t, Dr. Kru sz ews ki su bm it te d two su pp le m en ts to hi s rep or t. The fir st

su pp le m en t ci te d two ad di ti on al so ur ces

. Fi rs t was an art ic le by Dr. Pat ric ia Deeg an

pu bl is he d on the Nati on al Em po werm en t Cen te r web si te cl ai m in g: “ Diff eren t st ud ie s

qu ot e di ffer en t rat es of ta rd iv e dysk in es ia ran gi ng fro m 15 %-2 0% fo r pe op le us in g [an ti ps y ch ot ic s] fo r m or e th an th ree y ears .” The art ic le st at ed th at Zy pr ex a “ ha s be en

fo un d to cau se TD” bu t li st ed no so ur ces fo r it s in fo rm at io n. The se co nd ne w so ur ce

was a web pa ge whe re Dr. Pet er Br eg gi n adv ert is es hi s work as an ex pe rt witn es s in

TD-rel at ed cas es

. W it ho ut ci ti ng a so ur ce, t he web pa ge cl ai m s: “ The rat es fo r TD

are as tro no m ic al

. In ot he rwis e ph y si ca l l y h e al th y ad ul ts

, 5%- 8% pe r y ear wil l

-7

-de ve lo p th e di so rd er, wit h cu m ul at iv e rat es in th e ran ge of at le as t 15 %-2 0% fo r th e

fir st th ree y ears .” Dr. Breg gi n cl ai m s it is “ si m pl y un tru e” th at “ th e ne wer or at y pi cal

an ti ps y ch ot ic dr ug s cau se TD at a ve ry lo w rat e.” Aga in

, th e on ly Zy pr ex a-s pe ci fic

cl ai m was t ha t i t ca n c au se TD. 6

Dr. Kru sz ews ki ag ai n su pp le m en te d hi s re por t w ith a 2010 pe er -r ev ie wed st ud y

co m pa rin g TD in c i de nc e rat es fo r us ers of fir st -g en erat io n an d se co nd -g en erat io n

an ti ps y ch ot ic dr ug s. The st ud y co nc lu de d: “ [T]he in ci de nc e rat e of TD wit h at y pi cal 7

an ti ps y ch ot ic s, whi le m od es tl y red uc ed

, rem ai ns su bs ta nt ia l

. . . . Des pi te th e feel in g

am on g so m e cl in ic ia ns th at TD is m uc h le ss of a p r o b l e m no w in th e at y pi cal era,

su ch a co nc lu si on may un fo rtu na te ly be pr em at ur e.” As Lil ly po in te d ou t, two

im pl ic at io ns of th e st ud y da ta su gg es t th at bi po la r pa ti en ts ta ki ng Zy pr ex a can ex pe ct

be tt er res ul ts th an ot he r pa ti en ts

. Fi rs t, th e W oo ds st ud y no te s: “ Lit tl e TD ad va nt ag e

fo r at y pi cal s was ap pa ren t in sc hi zo ph ren ia su bjec ts

, whi l e a rel at iv el y st ro ng

ad va nt ag e was es ti m at ed in affe ct iv e di so rd er su bjec ts .” Seco nd

, ba se d on av ai la bl e

da ta di ffer en ti at in g s pe ci fic dr ug s, th e st ud y rep or te d th at “ ol an zap in e [Zy pr ex a]

sh owe d t he lo wes t re la ti ve TD rate” in th e se co nd -g en erat io n g ro up

.

The di st ric t co ur t co nc lu de d th at Dr. Krus zews ki ’s firs t s up pl em en t -- a bl og

po st an d web si te ad ve rti si ng -- “ are a de fic ie nt fo un da ti on ” t o su pp or t Dr.

The ci te fo r Dr. Deeg an ’s art ic le is Tard iv e Dy sk in es ia an d Tard iv e Dy st on ia : 6

whe re y ou can tu rn fo r he lp

, Nati on al Em po werm en t Cen te r, ht tp :/ /www.p owe r2 u.

or g/ art ic le s/ se lfh el p/ ta rd iv e.h tm l (la st vi si te d Dec. 10

, 20 13 ). Dr. Breg gi n’s ci te is
Sel ect ed Tard iv e Dy sk in e s i a (TD) cas es , Ps y ch ia tri c Dru g Fact s wit h Dr. Pet er Breg gi n, ht tp :/ /b reg gi n.c om /i nd ex .ph p? op ti on =co m

_c on te nt &t as k= vi ew&i d= 18 4 (la st vi si te d Dec. 10

, 20 13 ). Co pi es of th es e in te rn et m at e r i a ls are on fil e in th e Cl erk ’s Offic e.

W oo ds , S .W ., e t. al ., In ci de nc e of Tard iv e Dy sk in es ia wit h At yp i c a l Vers us 7

Co nv en ti on al Ant ip sycho ti c Med ic at io ns : A P r o s p e ct iv e Co ho rt St ud y , J. Cl in

. Ps y ch ia try 71 (4 ): 4 63 -4 74 (20 10 ) (t he “ W oo ds st ud y ”).

-8

-Kru sz ews ki ’s 15 % ris k fig ur e. Tho ug h th e se co nd su pp le m en t was a pe er-r ev ie wed

st ud y in a well res pe ct ed jou rn al

, th e co ur t reas on ed

, th e Woo ds st ud y “ was no t

de si gn ed to es ta bl is h th e ris k of a pa rti cu la r dr ug , on ly th e ris k of a cl as s of dr ug s to

whi ch Zy pr ex a be lo ng s.” The W oo ds st ud y “ do es no t ev en at te m pt to es ta bl is h th at
Zy pr ex a is a twi n to co nv en ti on al an ti ps y ch ot ic s,” a n d it “ in di cat es th at Zy pr ex a

carr ie s a lo wer ris k of [TD] th an ot he r at y pi cal an ti ps y ch ot ic s.” Co nc lu di ng th ere “ is

to o gr eat an an al y ti cal ga p to ex tra ct f r o m th e W oo ds st ud y th e 15 % i nc id en ce rat e

Dr. Mi ll er sa id wou ld ha ve ch an ge d hi s pr es cri bi ng de ci si on s,” th e co ur t ex cl ud ed al l

ev id en ce of th at ris k pe rcen ta ge un de r Dau be rt. The co ur t th en gr an te d s um m ary jud gm en t di sm is si ng Bo eh m ’s fai lu re-t o- warn cl ai m s be cau se th ere was no ge nu in e

is su e o f m at eri al fact as t o t he ad eq ua cy of Li ll y ’s TD warni ng s.

II I.

On ap pe al

, Bo eh m arg ue s th e di st ric t cour t er re d in excl ud in g Dr. Kru sz ews ki ’s

ex pe rt op in io n th at 15 % o f Zyp r e x a us ers wil l de ve lo p TD a fte r th ree y ears of us e.

Bec au se th e gr an t of su m

m ary jud gm en t tu rn ed on th is ru li ng , we wil l rev ie w it fir st

. Ju nk v. Term in ix In t’l Co

., 62 8 F.3 d 43 9, 44 7 (8 th Ci r. 20 10 ), cert

. de ni ed

, 13 2 S. Ct

. 94 an d 95 (2 01 1)

. “ W e rev ers e a tri al co ur t’s de ci si on on th e ad m is si bi li ty of ex pe rt

ev id en ce o nl y

on th e b as is of a cle ar an d p reju di ci al ab us e o f di sc ret io n.” Id.

In de te rm in in g whe th er to ad m it a qu al ifi ed ex pe rt’s op in io n te st im on y un de r

Ru le 70 2 of th e Fed eral Ru le of Ev i d e n c e , th e di st ric t co ur t act s as a ga te ke ep er to

“ en su re th at an y an d al l sc ie nt ifi c te st im on y or ev id en ce ad m it te d is no t on ly rel ev an t,

bu t rel ia bl e.” Dau be rt, 50 9 U.S. at 58 9. If “ op in io n ev id e n c e

. . . i s co nn ect ed to

ex is ti ng da ta on ly by th e ip se di xi t of th e ex pe rt,” a di st ric t co ur t “ m ay co nc lu de th at

th ere is si m

pl y to o gr eat an an al y ti cal ga p be twee n th e d a t a a n d t h e op in io n

pr of fere d.” Gen. El ec. Co . v. J oi ne r, 52 2 U.S. 1 36 , 14 6 (1 99 7)

.

-9

-Here, aft er gi vi ng Bo eh m am pl e op po rtu ni ty to su pp le m en t Dr. Kru sz ews ki ’s

in it ia l, i na de qu at el y

su pp or te d o pi ni on , th e di st ric t cou rt reas on ab ly co nc lu de d t ha t

Bo eh m ha d n ot pro vi de d s uf

fic ie nt sci en ti fic su pp or t fo r th at op in io n. Th e in te rn et

m at eri al s in th e fi r s t s up pl em en t pr ov id ed no su pp or ti ng da ta or so ur ces fo r th ei r

ge ne ral as se rti on s rel at in g to Zy pr ex a; th e W oo ds s t ud y , whi le pe er-r ev ie wed

, was

no t de si gn ed to es ta bl is h a TD i n c i d e n c e rat e fo r Zy pr ex a an d in fact co nt ai ne d

fin di ng s th at unde rm

ine d D r. K ru sz ews ki ’s op in io n th at Zy pr ex a cau se s TD in bi po la r

pa ti en ts at t he same 15 -2 0% ra te as f irs t-g en erat io n a nt ip sycho ti cs . On th is reco rd

,

we co nc lu de th at it was well wit hi n th e di st ric t co ur t ’s s u b s t a n ti al di sc ret io n to

ex cl ud e Dr. Kru sz ews ki ’s 15 % ris k o pi ni on

.

IV.

Bo eh m fu rth er arg ue s th e di st ric t co ur t erre d in gr an ti n g su m m ary jud gm en t

di sm is si ng th e fai lu re-t o- warn cl ai m , ev en wit ho ut Dr. Kr u s z ews ki ’s 15 % ris k

op in io n. The le arn ed in te rm ed ia ry do ct rin e do es no t ap pl y , Bo eh m arg ue s, be cau se

he pr es en te d su bs ta nt ia l ev id en ce th at Lil ly’ s warn in g to ph y si ci an s as to th e ris k of

de ve lo pi ng TD aft er lo ng -te rm us e of Zy pr ex a was in ad eq ua t e

. Th e di st ric t co ur t

care fu ll y su m

m ari zed “ th e es se nt ia l an d un di sp ut ed m at eri al fact s” th at warra nt ed th e

gr an t of su m

m ary jud gm en t ab se nt rel ia bl e sc ie nt ifi c ev id en ce of a kn own 15 % ris k

fact or for lo ng -te rm

us e o f Zy

pr ex a:

Lil ly’ s pa ck ag e in se rt warn ed th e pr es cri bi ng do ct or s th at

, th ou gh [TD]

was an in freq ue nt si de effe ct

, th e ris k th at it wo ul d oc cu r an d be co m e irr ev ers ib le

. . . was be li ev ed to in c r e a s e a s tre at m en t co nt in ue d ov er ti m e an d th e pa ti e n t ’s to ta l cu m ul at iv e do se in crea se d.

. . . No st ud ie s

or ot he r ev id en ce ex is te d to gu id e pr es cri be rs ab ou t de pl oyin g th e dr ug fo r m or e th an on e m on th

. . . . Drs. Mi ll er an d Kacze ns ki kn ew al l th es e ris ks fro m read in g th e Zy

pr ex a pa ck ag e in se rt an d fro m th ei r ex pe rie nc e wit h fir st an d se co nd ge ne rat io n an ti -p sycho ti c m ed ic in es

. Th ey

pr es cri be d Zy

pr ex a fo r Tim ot hy Bo eh m acro ss man y y ears be cau se , weig hi ng th e ris ks ag ai ns t th e b en efi ts of tre at in g hi s bi po la r di so rd er,

-1 0-in th ei r op in io n th e dr ug he lp ed hi m

. The se two mai n pr es cri be rs

th ou gh t Lil ly’ s warn in g ad eq ua te

. Bo th are st il l pr es cri bi ng Zy pr ex a to

ot he r pa ti en ts

.

Afte r care fu l co ns id erat io n of th e ex te ns iv e su m m ary jud gm en t reco rd

, we ag ree. On

ap pe al

, Bo eh m pl aces gr eat em ph as is on th e t e s t im on y in whi ch Dr. Mi ll er ag reed

th at pr es cri bi ng Zy

pr ex a fo r th ree ye a r s w as “ to o lo ng ” gi ve n th e 15 % ris k of

de ve lo pi ng TD. Bu t th at te st im on y was ba se d on Bo eh m ’s co un se l in st r u c t i n g Dr.

Mi ll er th at a 15 % ris k fact or fo r Zy pr ex a us ers ha d be en es t a b l i sh ed by Dr.

Kacze ns ki ’s te st im on y , whi ch was un tru e. On th is reco rd

, th e di st ric t co ur t pr op erl y

ap pl ie d t he lea rn ed in te rm ed ia ry do ct rin e in di sm is si ng th e fai lu re-t o- warn cla im

.

V.

Bo eh m fu rth er arg ue s th e di st ric t co ur t erre d in r eject in g hi s co nt en ti on th at

Lil ly’ s ov erp ro m ot io n of Zy pr ex a ne ga te d an ot he rwis e ad eq ua te warn in g of th e ris k

th at us ers wil l de ve lo p m ov em en t di so rd ers in cl ud in g TD. A few co ur ts ha ve

reco gn iz ed an ov erp ro m ot io n “ ex cep ti on ” to th e le arn ed in te rm ed ia ry do ct rin e. The

S u p r e me Co ur t of Ark an sa s ha s no t ad dr es se d th e is su e. The ex cep ti on ap pl ie s in

“ un us ua l cas es ” whe re a pl ai nt iff can “ es ta bl is h wit h in di vi du al iz ed pr oo f” th at a dr ug

m an uf act ur er’s ex ces si ve pr om ot io n of it s pr od uc t “ cau se d th e [p la in ti ff’s] ph y si ci an

to in it ia te or m ai nt ai n th e pr es cri pt io n at is su e

. ” I n r e Zy pr ex a Pro ds

. Liab

. Lit ig

., 64 9 F . Sup p. 2 d 1 8, 3 3 (E.D.N.Y. 20 09 ) (em ph as is in ori gi na l).

Here, th e di st ric t co u r t e x pr es se d do ub t th at th e Su pr em e Co ur t of Ark an sa s

wou ld reco gn iz e an ov erp ro m ot io n ex cep ti on to th e le arn ed in te rm ed ia ry do ct rin e.

Bu t in an y ev en t, t h e c o u r t c on cl ud ed

, th e ex cep ti on wou ld no t ap pl y in th is cas e

be cau se Bo eh m pr es en te d “ no ev id en ce th at an y rep res en ta ti on by a sa le sp ers on

affe ct ed a pr es cri bi ng do ct or ’s de ci si on to co nt in ue Bo eh m on Zy pr ex a,” an d be cau se

-1 1-“ [t]he re is no rel ia bl e ev id en ce th at Zy pr ex a ha d si gn ifi can tl y m or e ris k of m ov em en t

di so rd ers th an th e d ru g re ps all eg ed ly said it ha d.” W e ag ree.

The su m m ary jud gm en t reco rd in cl ud es su bs ta nt ia l ev id en c e t ha t Lil ly

ag gr es si ve ly m ark et ed Zy pr ex a to do ct or s, i nc lu di ng Dr. Mil le r an d Dr. Kac zen sk i,

in st ru ct in g it s m ark et in g rep res en ta ti ve s to m ak e pe rs on al cal ls to pr om ot e Zy pr ex a by di sc us si ng bi p o l ar sym pt om s an d st res si ng Zy

pr ex a’s “ sa fet y ,” “ effi cacy,” an d

“ eas e of us e” fo r tre at in g bi po la r pa ti en ts

. Bu t th ere is n o e v id en ce th at an y

rep re s e n t at iv e m ad e st at em en ts to Dr. Mi ll er or to Dr. Kacze ns ki th at ne ga te d th e

pa ck ag e in se rt warn in g, an d th ere is no ev id en ce th ei r pr es cri bi ng de ci si on s were

affe ct ed by th e Lil ly rep res en ta ti ve s’ st at em en ts reg ard in g th e ris k of TD. The refo re,

ev en if Ark an sa s wou ld reco gn iz e t h i s ex cep ti on , Bo eh m fai le d to pr ov e th at Lil ly

ov erp ro m ot ed Zy

pr ex a, th at it s pr om ot io na l effo rts ne ga te d th e writ te n warn in gs , or

th at th es e p ro m ot io na l ef fo rts ha d an y effe ct on th e d eci si on s b y Dr. Mil le r an d Dr.

Kacze ns k i t o p r es cri be Zy pr ex a fo r th e co nt in ue d tre at m en t of Bo eh m ’s bi po la r

di so r d e r

. Acco rd Dean v. Eli Lil ly & Co

., 38 7 Fed

. App ’x 28

, 30 (2 d Ci r. 20 10 )
(u np ub li sh ed ); Pa t t e s o n v

. Ast raZen eca, L.P., 87 6 F. Su pp

. 2d 27

, 34 -3 7 (D.D.C.

20 12 ); I n re Zy

pr ex a Lit ig at io n, 6 49 F. Sup p. 2 d a t 3 3.

The jud gm en t o f th e d is tri ct co ur t i s af fir m ed

.

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

-1 2-