### NUM BERS 13-0 7-00 301- CV 

## COURT OF A PP EA LS T H I R T E E N T H D I S T R I C T O F T E X AS C OR P U S C H R I S T I -E D I N B U R G
CEN TOC OR, INC
. A pp ellan t,
v. PATRICIA

HA M ILTON, THOM AS HA M ILTON, A ND M ICH A EL G. B UL LE N, M .D., A pp ellees .

On a p p ea l f ro m C o u n ty C o u rta t L awN o . 4 of N ue ces Co un ty , T exas . 

## O P I N I O N B efo re J u st ic es Y añ ez , R o d rig u ez , a n d V el a

Opin ion b y

Ju stice Ya ñe z Our me dical-legal jurispruden ce is based on ima ges of hea lth care that no l ong er

ex is t. At an earl ier

time, medi cal adv ic e w as re cei v ed i n the doct or ’s off ic e from a phy si ci an w ho mos t li kel y m ade house cal ls if needed. The pati ent u sual ly

pai d a s mall su m of money to t he doctor

. Nei g hbor hood phar maci sts co mpounded p re sc ri bed medici nes. W it hout bei ng pej orati v e,2

iti s s afe to say that the prev ail ing atti tude of l aw and medic ine w as that the “docto r know s best. ” Pharmaceut ic al manufacturers n ev er adv erti sed thei r product s t o pati ents , but ra ther direct ed all sal es efforts at ph y si ci ans. I n thi s c omforti ng settin g, the law create d an ex cept ion to the tradition al dut y of man ufactu rers t o w a r n c o n s u me rs d i re c t l y o f r i s k s a s s o c i a t e d w i t h t h e p ro d u c tas l ong as they w ar ned hea lt h- care prov ide rs of thos e r is ks

. Fo r goo d or il l, th a t h a s a ll ch a n ged . Me d ica l se rvi c e s a re in la rge me asure provi ded b y man aged care o rg anizations. M edicine s are purchas ed i n the phar macy depar tment of super mark ets and often pai d for by thi rd -p arty

prov ide rs
. Dr ug manufacturers now direct ly adv erti se product s to con sum ers on th e rad io , t elevision, the Inte rnet, billboards o n pu blic transp ortat ion, a nd in m agazi nes. Perez v. W yeth Lab s. , 734 A.2d 124 5, 12 46-4 7 (N.J. 199 9) (citation om itted ). Ag ain st thi s b ack drop, w e are c all ed upon to deci de w hether a dr ug manufacturer
can re ly on it s adeq uate w ar nin g s to phy si ci ans to sat is fy it s duty to w ar n th e ul ti mate
cons umer, the pati ent, w hen i t di re ctl y adv erti se s t o the pati ent i n a mi sl eadi ng fashi on. W e hol d i t c annot. Patr ic ia and Thomas Hami lt on s ued C entoc or , I nc. and othe rs after Pat ri ci a s uffered from a dr ug -i nduce d l upus- li ke sy ndrome all eg edl y caus ed by her us e of Re mic ade, a dr ug Cen toc or

manufa ctured

. Patr ic ia w as show n a v ide o tha t s he al leg ed ov er-e mphasi z ed the b enefits of Remi cade but i ntent ion all y omi tted w ar nin g s a bout the a dv erse si de- effect s she su f fered

. A jury foun d in favor of the Ham iltons on all issues presente d. T he trial cou rt entered j udg ment on the j ur y ’s v erd ict i n Patri ci a’s fav or for $ 4,687, 461.70 in act ual and pun itiv e dam ages, and in T hom as’s favor for $12 0,8 33. 71 in actu al and pun itiv e da ma ges, based on t he j ur

y ’s findi ng of fraud. By numerous is sues , C entoc o r a rg ues that (1 ) the “l ear ned i nter mediar

y ” doct ri ne precl udes the Ha m il tons ’ cl aims bec ause Cen toc or adeq uatel y

w ar ned Pa tr ic ia’ s p hy si ci ans; ( 2) the Hami lt ons faile d to presentl eg all y andT he H am i l t ons f i l ed a condi t i onal cr oss- appea l ar gui ng t hat i f t he “ l ear ned i nt erm ed i ary ” d oct r i ne 1 appl i es t o no n- pr escr i bi ng d oc t ors, t hen t hi s C our t shou l d gr anta new t r i al f orH am i l t on’ s cl ai m s aga i nst M i chael Bul l en, M

. D

. Because we r ecogni z e an except i on t o t he “ l ear ned i nt er m edi ar y ” doct r i ne i n t hi s case, w e d o n o t re a c h th i s c o n d i ti o n a l c ro s s -is s u e
. See T EX
. R. A PP
. P. 47. 1. 3 factu ally su f f icient evidence of

ca usat ion; (3) th e evidence of f raud byomission is l egally and factu all y

i nsuffici ent; (4 ) the Hami lt ons canno t maint ain a caus e of act ion for i mpli ed mis re p re s e n t a t i o n , a n d t h e i r i mp l i e d mi s re p re s e n t a t i o n c l a i ms fa i l i n d i v i d u a l l y ; (5 ) the Ham iltons failed to prese nt expert test imo ny on th e stan dard of care; (6) there is no cau se of acti on for neg li g ent mi sbrandi ng ; ( 7) the dis tr ibu ti on of the v ide otape did not cons ti tute negligent und ertakin g; ( 8) the e v iden ce of f utu re dam ages is leg al ly a n d factu ally ins uff ic ien t; (9 ) Thomas c annot re cov er on h is der iv ati v e c lai ms; and ( 10) the jud g ment shoul d be re mitt ed bec ause the t ri al cour t mi sappl ied the puni ti v e damag es cap. Todayw e re cog niz e an ex cept ion to the lea rn ed i nter mediar y doctr ine w hen a dr ug
ma nufactu rer directly

advertises to its co nsum ers in a f raud ulen t ma nne r. W e f urthe r hold 1 that the c ausat ion ev ide nce and t he ev ide nce of f ra ud is leg all y and factual ly

su ff ic ien t t o supp ort the judgme nt. W e ho ld, ho w ever, that Pa tricia did notpresen t suf f icient evidence of f utu re pain a nd men tal an guish dam ages. Finally , w e ho ld tha t the trial court prope rly app lied the pun itiv e da ma ges cap. Accordin gly , w e rev erse the t rial cou rt’s award o f f utu re pain and men tal anguish dam ages, mo dif y the judgme nt to ref lect this cha nge, an d af f irm
as modified

. I. B A CKGRO UND A . Crohn’s Disea se a nd Remicade Accordin g to Pa tricia’s g astroent erol og i s t, R on al d H au pt ma n, M .D., Crohn’s dise ase is a n a u toim mu ne d isease thatcause s a chronic inf lam ma tion o f the inte stines. It can4

involv e an y

part of t h e g a s trointe stinal tract f rom th e mo uth to the anu s, butit primarily inv olv es the d is tal smal l bowe l and t he c olo n. Crohn’ s d is ease beg ins w it h a “ flare” of infla mmation that caus es ser iou s pai n i n the i ntes ti nes, w hic h ty pic all y i ncreases i n s ev er ity and durati on. There is cu rre n tl y no “ cure” for C ro hn’ s d is ease; how ev er , t here are s ev eral treat me nt op tions. Dr . Haup tm an te stif ied th at th e treat me nt fo r a patien t’s Crohn’s dis ease depends on t he sev er ity of t he dis ease both before a nd atthe ti me of treatment. The g oal of treatment is to cont ro l the i ntes ti nal i nflammati on. In re cent medic al his tor

y , ste ro ids w ere the first dr ug s u sed to t re at C ro hn’ s d is ease. For ex ample, dur ing a “fla re ” of t he dis ease, predni sone is a s teroid treatment that can be used to redu ce inf lam ma tion. As techno lo gy ad v ance d, drugs called “5-ASA ” w ere dev elo ped, w hic h are ant i- infla mmator y medic ati ons doct ors use to maint ain re mis si on of the d is ease. Lat er , i mmunosuppress ants w ere dev elo ped i n an attemptto a ddress the imm une sy stem problem and supp ress t he i nfl am ma to r y c om pon entthatatta cks the bo w el. Imuran i s a n i mmunosuppress ant freq uentl y us ed for thi s p ur pose. If lef t unt reate d, Crohn ’s disease can cau se the patie nt to lose the abilityto digest food . A sev ere flare, w ithou t ef fective treatm ent , can resu lt in a patie nt requiring surgery to remov e i nflamed por ti ons of the bowel, wh ich i s ca ll ed a “resecti on.” Ad dit ion all y , a col ost omyca n be per formed, w here the bow el is di v erted t o ex itt h e abdomen. A colosto my bag i s then atta ched t hatp ermits the p atien t to pa ss stools into the ba g, w hich must be drain ed by

the pati ent, ins tead of the nor mal w ast e el imi nati on proces s. Cen toc or is a subs idi ar y of Johns on & Johns on, I nc. I n N ov ember 1998, C entoc or
re cei v ed approv al from the federal F ood and D ru g Admi n ist rati on ( “F DA ”)for t he dr ug5

Remi cade, w hic h w as approv ed to treat C ro hn’ s d is ease. Lat er , Remi cade w as approv ed to t re at r heumatoi d arthr it is

. Remi cade is an immunos uppress ant. It w or ks by bi ndi ng to and blocking the ha rmf ul ef fects of tum or necrosis facto r ( “TNF”), a substa nce n at u ra lly produce d by

the body

thatca uses i nflammati on. Cen toc or

ca ll ed Bar bara M atthews, M.D. , t o tes ti fy at t ri al about the a pprov al proces s a t t he F DA

. Dr . M atthe w s wor ked for th e F DA between 199 4 and 2000 an d w as the c li nic al re v iewer

for Centoc or ’s appli cat ion for FDA approv al of Remi cade. Ac cordin g to D r. Ma tthews, w hen a dr ug is approv ed, the d ru g manufacturer drafts w hat i s c all ed a “packa ge insert,” w hich contain s w arnings and oth er informa tion abou t the drug. The FDA
rev iew s the pro pose d pa ckage insert an d ma kes revi s ions. After the packa ge insert is approv ed, i t i s ty pic all y rev is ed ov er

ti me as new

i nformati on bec omes a v ail abl e. On A ug us t 8, 2 00 1, t he Remicad e pa c k ag e i ns er t w ar ne d of l up us - l i k e s y nd rom e
as follo w s: PR EC A UT ION S: A utoimmunity Treat ment w it h R EM IC AD E may resul t in t he format ion of autoant ibo die s and, ra re ly , i n the dev elo pment of a lu p u s-l ike sy ndrome. If a pati ent dev elo ps sy mptoms sug g est iv e of a lup us- li ke sy ndrome foll ow ing treatment w it h R EM IC AD E, t re atment shoul d be dis cont inu ed ( see AD VER SE RE A CT I O NS , A u to a n t

ib o d ie s / L u p u s -l ike S y n d ro me ).

. . . . A DV ER SE R EACT ION S:

. . . . A ut oan ti bo di es/L up us- like Sy nd ro me In t he ATTRAC T rhe umatoi d ar thr it is st udy

th roug h w eek 54, 4 9% o f RE MI CA DE -t re ated pati ents dev elo ped ant i- nucl ear anti bodi es (A NA ) betw een sc re eni ng and las t ev alu ati on, compared to 21% of plac ebo- treated6

pati ents . An ti -d sD NA

anti bodi es deve lo p ed i n approx imat ely 10% of RE MI CA DE -t re ated pati ents , c ompared to none of the pl acebo -t re ated pati ents

. No ass oci ati on w as seen betw een R EM IC AD E dos e/s chedu le and dev elo pment of AN A or anti -d sD NA

. Of Crohn’ s d is ease pati ents treated w it h R EM IC AD E w ho w ere ev alu ated for anti nucl ear

anti bodi es (A NA ), 34% dev elo ped AN A betw een s creeni ng and las t ev alu ati on. Anti -d sDN A ant ibo die s d ev elo ped i n approx imat ely 9% of Crohn’s disea se pat ients treat ed wi th REMICADE. T he d evelopm entofantidsD NA anti bodi es w as not rela ted t o ei ther the dose or

durati on of RE M I C A D E t r e a t me n t

. H o w e v e r , b a s e l i n e t h e r apy w it h an immunos uppress ant i n C ro hn’ s dis e ase pati ents w as ass oci ated w it h the redu ced d evelopm entof ant i- d sDNA antibo dies (3% com pare d to 21 % in p a t i e n t s n o tre c e i v i n g a n y i mm u n o s u p p re s s a n t )

. C ro h n ’ s d i s e a s e pati ents w ere ap proximate ly

2 time s mo re likely

to develop a nti-dsDNA an tibod ies if t h e y we re A NAp o s it ive a tst u d y e n t ry. In c li nic a l s t udi es, three pat ien ts dev elo ped c li nic al sy mptoms cons is tent w it h lupu s-like sy ndro me , tw o w ith rheu ma toid a rt hritis and o ne wi th Crohn ’s dis ease. Al l three patien ts improv ed foll ow ing disc onti nuati on of therapy and appropr iat e medi cal treatment. No cas es of lupus -l ik e react ion s h av e been obser v ed i n up to t hree y ears o f long -t er m foll ow up ( see PR EC

AU TI ON S, Autoi m m unity ). Dr . M atthe w s e x pla ine d tha t i f a ri sk ass oci ated w it h a d ru g ’s treatment is i ncl uded on the pack ag e i nser

t, that ri sk

i s reason abl y

as soc iat ed w it h the treatment. B. Ev idence of Centocor’s Mark eting Strategy As of June 200 0, Cen toco r’s marketing strategy include d a two-pronged ap proa ch that inc lud ed educa ti ng phy si ci ans to “refine thei r defini ti on of the ta rg et R emic ade pat ien t” and t o tea ch pati ents to “d emand Remi cade. ” Cen toc or ’s g oal w as to make Remi cade “t op
o f m in d ” fo r e ve ry r h e u m a t o id a rt h ri t is p a t ie n t

. A c h a rta d m it t e d in t o e vid e n c e sh o ws Cen toc or ’s p l a n fo r a d d re s s i n g p a t i e n t s , a n d i t s t a t e s t h a t t h e g o a l i s t o “ [ m] a k e the
cons umer aw are the [medi cal ] probl em is t re atabl e” and to “ [e]nc ourag e the pati ent t o request a spe cif ic drug.” Cen toc or

al so re q uired i ts sal es ass oci ates t o s ell a s peci fic n umber of v ial s o f7

Remi cade to do cto rs ’ off ic es. Dav id Du ll nig , C entoc or ’s l ocal R eg ion al Trai nin g M anag er for sales, te stif ied th at as of A ugust 200 2, his goal was to “work on [d octo rs] being more ag g re ss iv e i n presc ri bin g R emic a d e .” One of these strateg ies i ncl uded en courag ing doct ors to provide Remica d e in f usion s in their of f ice to m aximiz e the prof its the do ctors coul d real iz e from presc ri bin g R emic ade. D r. H auptman tes ti fied th at a re present ati v e from Cen toc or

approache d hi m to d is cus s t he ec onomicbenefit s t hat c oul d be obta ined beca use Med icare and Medicaid w ill pay fo r Remicad e inf usion s; thu s the do ctors could
ma ke mo ney from prescribing Remicad e an d providing the inf usion s in their of f ices. Cento cor also att e m p t e d to m inimize negative publicityabo ut th e po ten tially dan gerous side ef

fects of Remicad e. T he Ham il t o n s called T hom as Schia ble, th e v ice presi dent of medic al affairs for C entoc or , w ho tes ti fied about a s ci enti fic s tudy sc hedul ed to be publ is hed i n the Ne w Eng lan d J our nal of Me dic ine on F ebr uar y 13, 2003, demonst ra ti ng thatprobl ems w it h R emic ade had been understa ted. Ins tead of addre ss ing the s ubst anti v e s afetyco ncer ns ra is ed i n the ar ti cl e, C entoc or ’s “ Communica ti ons Program” recogniz ed th at th e New E n gl and Journa l of Medicine “traditio nally garners significan t me dia at ten tion, ” w hich includ es mu ltiple stories f iled by the Associat ed Pre ss. Ce n t o c o r’ s st a t e d o bje c t ive s in re s p o n d in g t o t h e n e ga t ive a rt ic le we re t o : (1 ) n e u t ra li ze the c ommerc ial i mpact of the publi cat ion , (2) confine the stor y to one new s cy cl e, an d ( 3) prov ide co ntext t o the st or ies thatappear
. Fur ther more, C entoc or

pl anned t o “[ d]ec re ase/ eli minat e news v alu e by pre- posi ti oni ng data as a ‘non- sto ry ’ w it h k ey medi a.” Dr. M atth ews t es ti fi ed t ha t i t w ou l d be “ hi g hl y u nu s ua l ” for

a d r ug c om pa ny

t o un de rtake a prog ra m to d il ute t he effect of a neg ati v e peer rev iew ar ti cl e. C. Dr ug -I nd uced L up us- Li ke Sy nd ro meD ur i ng t he t r i al , t he wi t nesses r ef er r ed t o “ l upus- l i k e sy ndr om e” and “d rug - i nduced l upus” 2 i n te rc h a n g e a b l y .

Le uk op en i a m ea ns a “[ l ] ow er t ha n t he no rm al am ou nt of w hi t e b l oo d c el l s
. ” See M edi ci neN et

. com , 3 D ef i ni t i on o fLeu k openi a, ht t p: / /www . m edt er m s. com / scr i pt / m ai n/ ar t

. as p ? a r t i c l e ke y = 4 1 4 9 ( l a s t v i si t ed Feb. 11, 20 10 ). Per i car di t i s i s def i ned as “ [ i ] nf l am m at i on o ft he l i ni ng a r ound t he h ear t ( t he p er i car di um ) causi ng

4 c he s t pa i n a nd ac c um ul ati on of fl ui d a rou nd t he he art (peri c ard i al effus i on ). ” See M edi ci neN et

. com , D ef i ni t i on of P eri c ard i t i s , http:// w w w . m ed t erm s
. c om / s c ri pt/ m ai n/art

. as p? art i c l ek ey =4 83 3 (l as t vi s i t ed F eb

. 11 , 20 10 ). 8 At t ri al, there w ere numerous desc ri pti ons of “l upus- li ke sy ndrome.” D r. H auptman and M ar y Ol sen, M .D ., an ex per t hired by

C entoc or

but cal led by

the Hami lt ons, tes ti fied tha t lupu s-like sy ndro me has cha racteristics similar to the auto imm une disorder systemic lup us er y sth ematos us (“ SLE” ), but iti s caus ed by a dr ug
. As so on as the offendi ng ag ent 2 is remov ed, t he s y mptoms g o aw ay
. Accordin g to all o f

t he doct ors t hatt estif ied on the subject , diagnosis of lupus-like sy nd ro m e c a n b e dif

f icult. Th ey generally agreed th at th e sy mp tom s of “lupus-like sy ndrome” inc lud e w eig ht ga in, join t pain and sw ell ing , fati g ue, u nusua l w eakne ss , rash,
oral ulc ers, fev er , l eukop eni a, and per ic ardit is

. A pati ent w it h C ro h n ’s di seas e or w it h 3 4 rheu ma toid a rthritis, a not her aut o-imm une d isease , could p resen t w ith similar sy mp tom s, li ke joi nt pa in. Laborator

y tes ts can be condu cte d to chec k for anti -n ucl ear

anti bodi es (“ AN A” ) and dou ble-stran ded DNA antibo dies (“anti-dsDNA” or “doub le-strand ed DNA an t ib odie s”). Adr ian a Pop- Mo ody , M .D ., tes ti fied th at t he AN A tes t i s “ li ke a s creen t est ” for l upus, but iti s n ot de finit iv e. Acc ordin g to Ati ll a Er tan, M. D. , t he mos t i mport ant t estfor d iag nosi ng lu p u s-like sy ndro me is the dou ble-stran ded DNA antibo dy test. Dr . Ertan testif ied th at if a pa tientt ests positive for d oub le-strand ed DNA a ntibo dies, the test is sugg estive of lupus-Sar coi dosi s i s def i ned as 5 [a ] d is e a s e o fu n k n o w n o r ig in th a t c a u s e s s m a ll lu m p s ( g r a n u lo m a s ) d u e to c h r o n ic i nf l am m at i on t o de v el op i n a gr eat ra nge ofbod y t i ssues. Sar coi dosi s can appea r i n al m ost anybod y or gan, butm ost of t en st ar t s i n t he l ungs orl y m ph n odes. I t al so aff ect s t he e y es, l i v erand sk i n; and l ess of t en t he spl een, bones, j oi nt s, sk el et al m uscl es, hea r t and cent r al ner v ous sy st em ( br ai n an d spi nal cor d)

. I n t he m aj or i t y of cases, t he g r anul om as cl earup wi t h orwi t hout t r eat m ent

. I n case s wher e t he g r anul om as do nothea l and di sappea r , t he t i s s ue s t en d t o rem ai n i nfl am ed an d b ec om e s c arred (f i bro t i c ). 9 li ke syn d rome. D r. Ol sen als o tes ti fied th at a tes t c an be condu cte d for “a nti his tone anti bodi es, ” w hic h woul d al so be s ug g est iv e of a dr ug -i nduce d l upus- li ke sy ndrome. Di ff ic ult ies ar is e i n di ag nosi ng a pati ent on Remic ade w it h a posi ti v e ANA t estand a pos it iv e doubl e- stranded D NA anti body tes t becau se pati ents re cei v ing R emic ade may tes t pos it iv e for thes e ant ibo die s w it h o u t h a vi ng l upus- li ke sy ndrome. Thus, Dr . O ls en explained thatto diagnose lupus-like sy ndro me , a doct or m ust look at bot h the laborat ory test resu lts and the clinical pres e n tatio n of sy mp tom s. According to Dr. Olsen, be cause a pos it iv e AN A and doubl e- stranded D NA anti body tes t may be p ro duced by

the Remi cade itself , a test tha t is p ositive for a ntihisto ne ant ibod ies gets h er a tten tion a nd ind icates lup usli ke sy ndrome. D. Pat rici a’s M edi cal H ist or y Pr io r t o 2001 P a t ri c ia h a s a co m p li c a t e d m e d ic a l h is t o ry. Att h e t im e o f t ri a l, P a t ri c ia wa s fo rt yseven y ears old a nd h ad su f fered f rom Crohn ’s disease for mo st of h er life. She w as f inally dia g nosed in 1977, w hen she w as sev enteen y ears old. Ov er the course of the d is ease, Pat ricia had un dergone multip le surgeries, inv olvi ng th e remo v al of section s of

her bowel, colon , and rectum ; she also had a perm ane nt co lo s t o m y. During one of the surgeries, Patr ic ia cont ra cte d hepati ti s C from a blo od transfusi on. Patr ic ia als o w as dia g nosed w it h sarcoido sis. 5See M edi c i neN e t

. com , D e f i n i t i o n of S arc o i d o s i s , M e d i c i neN e t

. com ,

h ttp ://w w w .m e d te rm s .c o m /s c rip t/m a i n /a rt.a s p ? a rti c l e k e y = 1 3 4 3 0 (l a s t vi s i te d F e b . 1 1 , 2 0 1 0 ).

Accor di ng t o t he t est i m onyat t r i al , rh eum at ol ogyi s a f i el d ofi nt er nal m edi ci ne speci al i z i ng i n t r eat i ng, 6 a m o n g o th e r th i n g s , j o i n t p a i n , i n fla m m a ti o n , a n d a u to -im m u n e d i s e a s e s , i n c l u d i n g l u p u s a n d s a rc o i d o s i s
.

D r
. H aupt m an’ s r ecor ds i ndi cat e t hat at t he t i m e Pat r i ci a f i r st cam e t o hi s o ffi c e, s he w as t aki ng 7 C el ebr ex. M i chael G ui r l , M

. D

. , t est i f i ed t hat C el ebr ex i s an ant i
- i nf l am m at or y m edi cat i on t hat i s used t o t r eat a v ar i et y of

cond i t i ons, i ncl udi ng a r t hr i t i s. 10 E. Ro nal d Hau pt man , M.D. On Jun e 1, 20 00, Patricia beca me a patie nt of Dr. Haup tm an, a gastroent erologist then pract ic ing i n C or pus Chr is ti , for her Crohn’ s dis ease. At that ti me, Pat ri ci a w as tak ing
v ar iou s medic ati ons re lat ed to he r medic al condi ti ons, i ncl udi ng the immunos uppress ant Imuran. Patr ic ia re por

ted t o Dr . Haupt man that s he w as not t aki ng any 5-ASA medic ati ons becau se she had an all erg icreact ion to thos e ty pe of dr ug s i n the pas t. In addi ti on to Crohn's dise ase, Pat ricia repo rted a h istoryof bleed ing from a duo den al ulcer, he pat itis C, ga s t ro e s o p h a ge a l re f lu x d is e a s e , sa rc o id o s is , a n d h o rm o n a l re p la c e m e n tt h e ra p y. Fur ther more, Pat ri ci a repor ted t o D r. H auptman that she had r heumatoi d ar thr it is

. Patr ic ia testi f ie d thatpr ior to mov ing to Cor pus Chr is ti , s he had seen a rh eumatol og is t i n Ty ler , Tex as, for p a in she w as ex per ien ci ng i n her hands

. The 6 rheu ma tologist told her tha t “any sof t tissue sw elling w as rheu ma toid a rthritis.” How ever, lab orator y tes ti ng for r heumatoi d ar thr it is w as not c onducte d o n P a tr ic ia at t hat t ime. Pat ricia ex plaine d tha t she rep orted this as part of her history t o D r. Ha upt ma n be cause she did not w ant t o l eav e outanythi ng thatmig ht be i mport ant. She sta ted t hat t he j oin t pain she experience d w as no t sig nif icant a nd th at atthe tim e she f irst w entto Dr. Hau ptman, she w as not t aki ng any medi cat ion for j oin t pai n. Dr . H auptman’ s n otes from 7 Patr ic ia’ s first v is itst ate t hat s he repor ted a “ rh eumatoi d ar

thr it is hi sto ry ” an d stated that11

“her han ds an d hips bo the r her the w orst.” Dr . H auptman re ferred Pa tr ici a t o a p ri mary ca re physi ci an, R obb Sh er ro n, M .D ., and t o a respi ra tor

y therapi st, i denti fied on lyas D r. M il ler , for her sa rc oid osi s. D r. M il ler performe d lab w ork o n Jun e 19 , 200 0. At tha t time , Patricia test ed n egative fo r r heu ma toid factor , w hic h i s t he i ndi cat or for r heum a toi d ar

thr it is

. Dr . H auptman conc eded t hat h e
never saw

any l abo ratory testin g tha t indicat ed th at Pa tricia had rhe um ato id arthritis. Addi ti onal ly , Pa tr ic ia’ s c hestx-ray sh ow ed no si g ns of sarcoi dos is. Dur ing thi s t ime, Patr ic ia' s C ro hn's di seas e w as asy mptomati c. In S eptember

2001, Pat ri ci a's C ro hn's di seas e ag ain bec ame s ymptomat ic

. In Decem ber 20 01, af

ter cond ucting diagnost ic tests, Dr. Haup tm an dete rmine d tha t Patricia
w as sufferin g a “ moderate f la re " o f h e r Crohn' s d is ease. Ba sed on her ex is ti ng medi cal
re g imen and her re por

ted all erg ic re act ion to the 5 -A SA c ateg or y of dr ug s, Dr . H auptman tes ti fied th at P atr ic ia' s o nly two treatment opti ons w ere s teroid s o r Remi cade. Dr . H auptman cl aimed that he di sc uss ed bot h opti ons w it h Patr ic ia. He tes ti fied th at Patr ic ia did not w ant t o tak e s teroid s b ecaus e s he did not li ke how she felt w hen s he to ok them. Althoug h Patri ci a c lai med thatD r. H auptman did not offer her a c ourse of steroid s
as an o ption , she agreed tha t she prob ably to ld Dr. Hau ptm an tha t she did no t like steroids. Dr . H auptman tes ti fied th at he als o di sc uss ed th e r is ks of usi ng R emic ade, inc lud ing the risk of d eveloping a lupus-like syndrome . Patricia and Th om as, ho w ever, de nied t hatDr. Haup tm an e v er discussed the risk of l u p u s -l ik e sy ndro me . Patricia testif ied th at in Dec ember

2001, she did not know w hat lupus or lupus -l ik e sy ndrome w as, and that hav ing that know led g e w oul d hav e been impor tant to he r. D r. H auptman presc ri bed an ind uct ion
ser ies of three dos es of Remi cade to be admi nis tered at an infusi on cl ini c o v er a s ix-weekT e s ti m o n y a t tri a l e s ta b l i s h e d th a t a n i n fu s i o n i n v o l v e s p l a c i n g a c a th e te r i n to th e p a ti e n t’ s a rm w i th 8 i n tra v e n o u s tu b i n g a n d i n fu s i n g th e m e d i c a ti o n d i re c tl y i n to th e p a ti e n t’ s ve i n
. 12 per iod from D ecember

19, 2001, to J anuar

y 30, 2002. F. Th e C ent oco r V id eo Dr . H auptman re ferred Pat ri ci a to the infusi on cli nicof Mic hael G. Bul len , M .D ., to
re cei v e the R emic ade i nfusion s. Pa trici a first w ent t o the cl ini c o n D ecember 17, 2001, 8 to recei v e a tubercul osi s tes t, w hic h mustbe p er formed before R emic ade c an be sta rt ed. At t hat t ime, Pol ly

Sw inn e y, a n u rse at the i nfusion cl ini c, took a hi sto ry

from Pa tr ic ia. Sw inn ey note d tha t Pa tr ici a r e por ted a hi sto ry

of arthr it is , butPat ri ci a di d notrepor t any pain associat ed wi th th e arthritis at th e time she f irst came to the clinic. Dr . Bu ll en testi fied that becaus e the decis ion to tak e Remic ade has al re ady been made by the ti me a pat ien t ar ri v es at hi s i nfusion cl ini c, he does not ty pic all y w ar n pat ien ts about adv erse si de ef

fects, ex ceptto prov ide them infor mati on abou t react ion s t hat mi g ht
occ ur dur ing the infusi on proces s. D r. Bul len tes ti fied th at he has a computer thatpr int s out dr ug infor mati on sheet s. H e c lai med thatw hen Pa tr ic ia came t o the i nfusion cl ini c o n Dec ember

19, 2001, for her

first infusi on, h e g av e Pat ri ci a one of these sheet s. H e di d not hav e a c opy

of the e x actsh eet t hat h e g av e Pat ri ci a, ex pla ini ng thatthe comput er i s n ow upd ate d w ith ne w

informa tion. How ever, a copy tha t he pri n t ed o ut in 20 04 right before trial did notconta in a w arning abo ut lup us-like sy ndro me . Dr . Bullen testif ied th at he did not war n Pat ri ci a aboutl upus- li ke sy ndrome. Sw inn ey st ated that she does not rev iew drug packag e inser

ts w it h patient s, and s he did not re v iew

the pack ag e i nser

t for Remi cade w it h Pat ri ci a at any ti me. R ather , s he compl etes a “ Pati ent Teac hin g Che ck li st, ” w hic h re q uires her to adv ic e pati ents of onl y the13

follo w ing side effect s: “headac he, chi ll s, fev er , nau sea, v omit ing , dyspnea , v erti g o, up per
re spi ra tor

y i nfecti ons, hy per

tens ion , [ and] hy potens ion .” Sw inn ey tes ti fied that thes e s ide effect s were ex pect ed and w atc hed for dur ing the infusi on proces s i tse lf. In ad dition to the checklist, Sw inne y showed pat ients a v ideo produ ced b y Cento cor. On D ecember 19, 2001, w hil e Patr ic ia w as re cei v ing her firs t infusi on, she w as show n the Cen toc or

v ide o, w hic h D r. Bul len referred to as a “ treatment companion ” ki t. D r. Bul len tes ti fied th at t he pur pose of the v ide o w as to s how “ some o f the e f

fe cts of the dr ug on
cer tai n peopl e. .
. . It' s v er y dramati c i n s ome peopl e.” T he video w as sho w n to th e jury . It begins by showin g a wo m a n wi th he r fa mily (“ Pati ent 1 "). Pa ti ent 1 st ates thatsh e has had thi s c ondi ti on for a w hil e now , and i t’ s s topped me from doi ng the ev er y day things tha t I used to do a ll th e t ime . I have two children , and [it] w as v ery h a rd fo r me t o fu l fi l l w h a t t h e y e x p e c t e d t h e i r mo m t o d o
. M y q u a l it yof l i fe wa s d e t e ri o ra t in g, a n d I wa s n o th a p p y. N ext, a ma n ap pe ars ( “ Pa ti en t 2" )

. H e s ta te s : “ I’ v e tr i ed s ev eral d i fferent d ru g s
. S om e
w ere more succ ess ful than othe rs , butnone re all y l ast ed a lon g ti me.” A different w oman then appears (“ Pati ent 3"). She is show n movi ng abouther ki tch en nor mall y , ope nin g the
re frig erator

. Pati ent 3 cl aims sh e w as “n ot ab le to do a l ot of thi ng s t hat I woul d hav e l ik ed to ha v e done. I felt li ke myl ife w as li mite d.” Pat ient 1 app ears again an d stat es: W e c oul dn’ t c ontrol wha t I had and t he doctors real ly w ere tr y ing many different medic ati ons for me. And basi cal ly thi ng s ju stw ent from bad t o w ors e
. Th e d e c i s i o n t o t r y R e mi c a d e w a s ma d e w i t h my d o c t ors. Itw as present ed to me th at t his mig ht he lp. W hile Pati ent 1 i s s peaki ng , s he i s s how n w alk ing nor mall y dow n the st re et an d i nto a bui ldi ng
. A nurse appears a nd ex pla ins thatthe infusi ons can tak e pl ace in a hos pit al or14

an inf usion clinic. Pat ient 1 ente rs an inf usion clinic and is g reete d by a nurse in a f riendly
ma nne r. A doct or app ears , i d e ntif ied as Ala n Safdi, M.D., w ho e x plains th at Rem icade is admini ste re d by

i ntrav enous i nfusion

. Dr . Sa fdi ex pla ins the infusi on proces s, and Pa ti ent 1 beg ins recei v ing an i nfusion . She is smi li ng and loo ks co mfortabl e. She s ay s t hat t he
w orst par

t of the procedu re is ins erti ng the needl e into a ve in. Dr . Sa fdi ex pla ins thatthe infusi on l ast s tw o to three hours. The three pat ien ts then tak e tur ns ex pla ini ng how , dur ing the i nfusion proces s, peopl e sleep , eat, watc h tel ev is ion , read, or make frie nds. The v ide o pai nts a po rt ra itof a rela x ed at mosphere. Pati ent 1 ex pla ins thata do cto r comes to chec k o n her dur ing her

i nfusion s. She sta tes thathe i s c heck ing to see if “ anythi ng i mmediat e is happeni ng dur ing the i nfusion .” Dr . Sa fdi the n s tates : Phy si ci ans shoul d di sc uss w it h the ir pati ents al l p o te n ti al si de effects that ma y occur during these inf usion s. Th ere are r e p o rts of serious infection s, includin g sepsis an d tub erculosis, th at m ay be life threa ten ing. So if y ou a re prone t o or

hav e a h is tor

y of infect ion s, cur re ntl y h a ve o n e or dev elo p one w hile ta king R emic ade, tel l y our doctor r ig ht away
. Al so tel l y our doctor before b eg inn ing treatment if y ou hav e had re centcl ose cont actw it h or i f y ou hav e had past

ex posure to peopl e w it h tuberc ulo si s, or if y ou hav e anyothe r re ason to be li ev e y ou may be a t r is k. There are a lso repor ts of ser iou s infusi on react ion s l ik e hiv es, diff ic ulty breathi ng , and l ow

bl ood press ure. If y ou hav e a d emy eli nati ng di seas e s uch as mult ipl e s cl erosi s, tel l y our doctor before you are treated. I n rare cases peopl e w it h demy eli nati ng di seas e w ho w ere treated w it h Remi cade hav e seen thei r sy mptoms int ensi fy. Up to on e in four peo ple ex per ien ced the fol low ing side effect s in cl ini cal st udi es: upp er re spi ra tor

y infect ion s, headac he, n ausea , c oug h, s inu si ti s, or mil d react ion s to the inf usion such as rash or itchy skin. But th e v ast m ajority of patie nts, in our ex per ien ce, hav e no probl ems w it h the i nfusion

. Dr . Sa fdi ex pla ins that after the infusi on, pati ents are k ept a t t he i nfusion ce nter for t h irty m in u t e s fo r o b s e rva t io n a n d t h a tm o s tp e o p le d ri ve t h e m s e lve s h o m e
. P a t ie n t2 sa ys15

that after his i nfusion s, he can do w hatev er he w ants , li ke “g ra b somethi ng to eat. I ca n g o bac k t o wor k i f I l ik e. I c an g o to the p ar k, w hatev er I w oul d ordin ar il y

hav e done. ” The vide o sh o ws Pa ti e n t 1 get ti n g up f ro m th e ch a ir in th e in f u sio n ce n te r an d le a ving. Dr . Sa fdi the n s ay s: Af ter the in f usion t here are v erylittle side ef fects th at pe ople nee d to watch for. If they have anydiscom fort, w e ask the m to g iv e us a call. But th ose reactio ns, again, are extremely rare. A nd the v ast m ajority of patie nts really ex per ien ce no s ide effect s. T he video again sho w s Patien t 1 w alking dow n the street. Sh e says: I u s u a ll y fe e l re a ll y go o d a f t e r th e in f u s io n a n d t h e n wh e n I ge t h o m e I re a li ze I’m tired . My

husb and w ill com e ho me early f rom work and let me rest a little b i t

. B u t t h a t ’ s a b o u t i t

. A n d t h e n I s t a rt fe e l i n g b e t t e r
. R e a ll ybett er
. And that’ s w hat I l ook forw ard to. Dr . Sa fdi appea rs ag ain and ex pla ins thatpati ents may not hav e a “ peak” effectfor
a w eek or

two after

i nfusion

. He says tha t th e d ru g i s “ q uit e effect iv e.” A dis cl aimer appears o n the sc re en th at s ay s, "RE SU LTS M AY VARY .” Pati ent 1 i s s how n agai n w alk ing dow n the st re et an d purchas ing flow ers, then she meets her family

. She pic ks up h er ch il dren and hug s t hem. Then she st ates , “ Remi cade is the drug thathelpe d me get bet ter. P eop le w ho [sic] w antto know i f that ’s g oing to ma ke them feel bette r, and for me, itwor ked. ” Pati ent 2 i s s how n g etti ng on a nd off a subw ay train and jog g ing up t he s tai rs out of the subw ay

stati on. He cl aims , “Si nce I beg an taki ng the dr ug , the qual ity of my l ife has def initely imp rov ed. ” Dr. Safdi the n exclaims, “I’m extremely en thu siastic abo ut this w hole
new cl ass of d ru g s! W e’v e hel ped peo ple w it h di seas e tha t has n’trespon ded t o oth er forms o f therap y .” Patient3 app ears in he r kitchen m aking cof fee. She s t a t e s, “I would def initely tell som eon e to try Rem icade . It’s def initely help ed m e.” Dr. S a fdi the n says,16

“Th is is a ne w

era for me dicine. T h is ty pe o f therap y . And it’s provided a lot of peo ple tremendous benefit

. And I w o u ldn’tbe s cared of the infusi on proces s i n and of its elf.” Pati ent 2 i s s how n throw ing a bal l w it h hi s d og
. He sta tes , “ It’ s b een not hin g but a g re at
suc ces s for

me.” Finally , Pat ient 1 is sh own w alking dow n som e stairs hold ing her children’s han ds. Sh e ea s i l y

p i c k s o ne o f he r

c hi l dren u p. S he st at es , “ The fact th att he re i s n o c ure for my condi ti on mak es it v er

y difficul t, but hav ing a dr ug that ’s g oin g to g iv e me bac k my q ual ity of li fe is the bestthatw e c oul d as k for .” At the end of

the video, a disclaim er rolls dow n the screen th at says: If y ou h ave any ques t io n s af ter w atch ing this v ideo , talk to your health care provider. Y ou ca n also visi t our w ebsite at w w w .rem icade .com for mo re infor mati on on RE MI CA DE

. This v ide o s houl d notbe u sed as a s ubst it ute for tal ki ng w it h y our

doctor

. Ind ication s REMICADE (inf lix ima b) is indicat ed for t he treat me nt of rhe um ato id arthritis and C ro hn’ s d is ease. Rheu ma toid a rthritis RE MI CA DE , i n c ombina ti on w it h methot re x ate, is i ndi cat ed for reduci ng the signs and sympto ms an d inhibitin g the progression of structural da ma ge in pati ents w it h moderatel y to sev erely

acti v e r heumatoi d ar

thr it is w ho hav e had an i nadeq uate re spons e to methotrex ate. Crohn’ s D is ease REMICADE is ind icated for t he redu ction in signs an d sy mp tom s of Crohn’s dis ease in pati ents w it h moderatel y to sev erely

acti v e Crohn’ s d is ease w ho hav e had an ina deq uate re spons e to conv enti onal therapi es. The s afetyand eff ic acy of therapy

co nti nued be y ond a s in gle dos e hav e notbeen est abl is hed. RE MI CA DE i s i ndi cat ed for the reduct ion i n the num b e r o f drai nin g17

enterocut aneous fist u la e i n pat ien ts w it h fis tul iz ing C ro hn’ s d is ease. The safety and eff ic acy

of therapy cont inu ed bey ond t hree dos es hav e notbeen stu die d. RE MI CA DE sh o u l d n o tb e a d m in is t e re d t o p a t ie n t s wit h kn o wn hy persens it iv ity

to any mur ine protei ns or

othe r componen t of the product

. T here are rep or

ts o f s er i ou s i nfe c ti on s , i nc l ud i ng s ep s i s a nd t ub erc ul os i s, that maybe l ife- threateni ng
. So, if you a re p ro ne to or hav e a h is tor

y of infection s, currently hav e on e, or d evelop one while ta king R EMICADE, te ll y our do c t o r ri gh t aw ay. Also tell y our do ctor before be ginning treatm entif y ou hav e had re cent cl ose cont act w it h, or if y ou hav e had pastex posure to peopl e w it h tub ercul osi s, or if y ou hav e anyother re ason to be li ev e y ou may be a t risk. T here are also repo rts of serious inf usion reaction s w ith hives, difficul ty breathi ng , and l ow

bl ood press ure. If y ou h a ve a de- my eli nati ng dis ease suc h as mul ti ple sc lerosi s, tel l y our doctor b e fo re y ou are treated. In rare c ases , peo ple w it h d e- my eli nati ng di seas e w ho w ere treated w it h REMICADE have seen their sy mp tom s inten sif y . Up t o o n e in fo ur peo ple experience d the followi ng side ef fects in clin ical studie s: upp er respiratory infect ion s, heada ch e , n ausea , c oug h, s inu si ti s o r mil d react ion s t o the i nfu s i on s uc h as ras h or i tc hy s k i n. ( Pl ea s e s ee th e ac c om pan y ing Full Presc ri bin g Infor mati on)

. It is undi sput ed th at t he v ide o di d notl is t l upus- li ke sy ndrome as a po tenti al si de effect

. Patr ic ia sai d tha t after wat ch in g t he v ide o, s he "feltv er y g ood abo ut R emic ade treatment. ” S h e e xpl ain ed, “ I t houg ht i t w as g oin g to chang e my l ife and make me feel g re at l ik e all the peopl e i n the v ide o." Patr ic ia sta ted t hat s he di d nothav e any co ncer ns about tak ing addi ti onal i nfusion s a fter watc hin g the v ide o and did not bel iev e she needed to do any

addi ti onal re search. Thomas te sti fied th at he w atc hed t he v ide o w it h Pat ri ci a at the i nfusion cl ini c. H e s tated thatthe v ide o “d idn 't re all y address anythi ng aboutsa fety , but
ev er y body se emed to be v er

y happy to hav e i t, on th e v ide otape. ” Sw in n ey testif ied th at th e v ideo tap es f rom Cen toco r come in boxes w rapp ed in celloph ane and that the boxes cont aining the v ideo s usua lly com e w ith “the video, a co uple of brochu res in there to tell abou t the drug

. . . and it usua lly com es w ith the packa ge insert18

that comes al so w it h the m edi cat ion s.” She stat ed th at t he pac kag e i nser t “ tel ls al l sor

ts of thin g s a bout the medi cat ion i tse lf: [h]ow it w as manufactured, s ome of the t est ing that
w as done, the s ide effect s, adv erse re act ion s, all those s o rt s, and t he dos ing .” Sh e tes ti fied th at t he “ full presc ri bin g i nformati on” refers to t he pac kag e i nser t. Sw inn ey adm itted , howev er, tha t she open ed the box and remo v ed the v ideo tap e to sho w Patricia the v ide o. Sw inn ey

cl aimed that after Patr ic ia w atc hed the v ide o, S w inn ey put the v ide o back i n the box

and g av e Pat ri ci a the box to tak e home. Patr ic ia came b ack

to the i nfusion ce nter

for tw o more i nfusion s o f Remi cade, one on Ja nua ry

2, 200 2, an d ano the r on Janu ary30, 20 02. At some pointin between th e f irst and s econd i nfusion s, Sw inn ey g av e Pat ri ci a a d if

fe re nt C entoc or

v ide o to tak e to her si ste r, w ho had rh eumatoi d ar thr it is

. This v ide o w as mark ed as Pl ain ti ff ’s Ex hib it35. The b o x con ta in in g th is vid e o ha s a pl a st ic sle e ve o n t h e i n sid e c o ver th a t co n ta in s t h e pa ck a ge ins ert for Remi cade. The v ide o s how n to Patr ic ia at t he i nfusion ce nter , howev er , w as m a rked a s Pl ain ti f f ’s Exh ibi t 34. I t doe s n ot ha v e a p las ti c s lee v e on the i nsi de to hol d any w ri tten mater ial s, and t he box onl y co ntai ns the v ide o. Sw inn ey admi tted thati f

a ny w ri tten mater ial s were i n the box , s he wo u ld hav e had to remov e the m to a cc ess the v ide o. Sw inn ey cl aimed that after she showed the v ide o to Patr ic ia, sh e putthe v ide o bac k i n the box and pla ced th e w ritten info rmat ion on top b efore she shut th e bo x . Patricia, ho w ever, testif ied th at she w as no t of fer e d a n y

w ritten m ate rials along w ith the v ideo . Patricia deni ed th at t he box

Sw inn ey g av e her cont ain ing the v ide o she w atc hed had any w ri tten infor m a tion i n i t. Pat ri ci a s tated thatsh e nev er opened the box

ag ain after

w atc hin g the
v ideo at the inf usion cente r, and i f t h e re w as an y

w ritten informa tion p rov ided , it would19

have bee n in the box w hen she gav e it to he r lawy er. Sw inn ey tes ti fied th at after

st arti ng the v ide otape, sh e di d notrevie w any othe r mater ial s w it h Pat ri ci a, an d s he di d notg iv e h e r a n y w ri tten mater ial s reg ardin g the si de effect s o f Remi cade. Sw inn ey furth er st ated thats h e d id not dis cus s t he pos si bil ity of lup us- li ke sy ndrome w it h Pat ri ci a. Initially, Patricia had a g ood respon se to t h e R e m ic a d e the rapy. Af ter her f irst infusi on, S w inn ey

ca ll ed Patr ic ia to see how she w as doin g , and Patri ci a repor ted that she
w as alread y

feeling bet ter. At he r second inf usion , Patricia told Sw inne y that“she had n’t felt be tter i n a long time and tha t she [felt] l ike she w as getting relief f rom her arthritis pain
as w ell as her

C ro hn’ s d is ease. ” After two i nfusion s, Dr . H auptman per formed a col onosc opy

thati ndi cat ed to hi m thatPat ri ci a’s C ro hn’ s dis ease w as in re mis si on. At h er thi rd i nfusion on Janua ry 30, 2002, Patr ic ia re por ted to Sw inn ey that she w as sti ll feeli ng much b etter

. At t hat p oin t, Patr ic ia bel iev ed that she w oul d onl y recei v e three R emic ade infusi ons and woul d be done. Iti s u ndi sput ed that sin ce rec eiv ing Remic ade, Patr ic ia has not h ad any

probl ems rela ted t o her C ro hn’ s d is ease, w hic h i s s ti ll i n remis si on. G. Patric ia’s Decline and Treatme nt by Adriana Pop-Mo ody , M.D. Patr ic ia ex pla ine d tha t i n M arch 2002, she beg an hav ing “ all ki nds of j oin t pai n and
w as hav ing a l ot of di ff ic ult ies .” Sh e tes ti fied th at s he h a d a r a sh a ll ov er her body , her throa t hurt , a n d sh e w as hu rting all over. T hom as test if ied th at Pa tricia w as in so mu ch pain t hatsh e could n ot dress herse lf o r pe rform h er norm al f unct ions. Sh e w entto see Dr. S h e rro n , h e r fa m il y p ra c t it io n e r. He o rd e re d b lo o d wo rk , a n d P a t ri c ia t h e n t e s t e d p o s it ive for r heumatoi d factor

and for AN A. Dr . Sh er ro n referred Pat ri ci a to Dr . Po p- Mo ody , a rh eumatol og is t. Pat ri ci a first v is it ed D r. Pop- Mo ody on A pr il 3, 2002.20

Dr . Po p- Mo ody

se nt a letter

to Dr . Sh er ro n after Pat ri ci a’s fir stvis it

. She
summar iz ed th e appoi ntment and her v iew of Patr ic ia’ s c ondi ti on: Mrs. Hami lt on has had Crohn’ s d ise a se si nce the a g e of 6 and for many y ears s he had joi nt pa ins

. Ini ti all y the hands w ere i nv olv ed. She ha d sw ell ing and pai n the n the r ig ht foot a nd th e r ig ht hi p. She di d nothav e l ots of f unct ion al li mita ti on and lot s o f dis comforti n t h e join ts[ ,] and t hey al l g ot bette r w hen s he w as hav ing the treatment done for C ro hn’ s w it h s teroid s o r Imuran. In Dec ember

and Janua ry

sh e recei v ed th e R emic ade t re atment. She receiv ed th ree do ses. T he f irst and seco nd d oses were tw o w eeks ap ar t[ ,] an d th e th i rd w as on e mo nt h ap ar t[ ,] an d th e C roh n’s sy mpto ms improv ed dramati cal ly

al ong w it h the j oin t s y mptoms. A pprox imat ely ei g ht w eeks after

the las t dos e of Remi cade she had a big flare- up of j oin t pai ns[ ,] and new joints are involv ed this time

. T he h and s and the right fo ot are very in f la m e d , very pa in f u l[ ,] bu t n o w sh e ha s sh o u ld e r pa in w it h di m in ish e d ran ge of motion, ankl e pai n and sw ell ing , w ri st and nec k p ain , t horaci c p ain [,] and als o l ow bac k p ain . S h e r e a ch e d the poi nt t hat s he c oul d hardly us e her hands

. Al so, sh e c annot dress hersel f, not ha v ing enoug h rang e of moti on in the shou lders. Dr . Pop-M oody

testi fied that Pa tr ic ia tol d her thatthe three dos es of Remi cade had dramati cal ly

al lev iat ed her

ar thr it is pai n, but in the tw o months si nce her l asttreatment, sh e had ex per ien ced a "flare" of ar thr it is pain

. D r. Pop- Mo ody presc ri bed a low

dos ag e of pred nison e, w hich is a steroid

. She also prescribed furth er inf usion s of Remicad e. Pat ricia tes ti fied th at, at t hat p oin t, she bel iev ed th at s he had dev elo ped r heumatoi d ar thr it is and
w oul d be on R emic ade for the restof her l ife. At Dr

. Pop- Mo ody ’s direct ion , Patr ic ia re cei v ed an infusi on of R emic ade on Apr il 10, 2002. Pat ri ci a tes ti fied th at w hen s he recei v ed a Remi cade infusi on, s he wou ld hav e a period of relief w here she co u ld resu me her norm al activi ties. Af ter the inf usion in April, Patr ic ia mis understo od that she w as suppos ed to sl ow ly tape r- off her predni sone, and she sto pped t he medi cat ion too ear ly

. She suffered a sev ere flare of ar thr it is st arti ng on M ay 12, 200 2. Her pain w as so ba d tha t she cou ld n o ts leep , could barely w alk, an d could21

bare ly get in and out of cars. Dr. Pop -Moody prescribed pred nison e again, an d P a t ri c ia g ot s li g htl y

bett er
. Patr icia ’s se cond infusi on of R emic ade und er Pop- Mo ody ’s ca re w as on M ay 23, 2002. W h e n s he s aw

D r. Pop- Mo ody

on J une 27, 2002, D r. Pop- Mo ody obs er v ed th at Patr ic ia w as doi ng “ bette r on R emic ade,” but for th e w eek pr ior to the v is it , Pa tr ic ia’ s h ands had bec ome st iff and pai nful w it h s ome l oss of g ri p streng th. Dr. Pop-M oody tes ti fied th at she condu cte d l ab wor k, and Patr ic ia w as posi ti v e for ANA. Dr. Pop-M oody

ex pla ine d tha t she w as not c oncer ned w it h l upus- li ke sy ndrome at thi s p oin t: E ve ryb o d y h a s t h e p e rc e p t io n — a n d d o c t o rs , lo t s o f d o c t o rs , i f

yo u h a ve posi ti ve— a re p o sit iv e AN A, h ey , I mig ht ha v e l upus.
. . . An d al so, i t' s n ot only that, th ere is ano the r test w hich i s more specif ic fo r lupus. So th e ANA t e s t , it ' s li k e a s c re e n t e s tfo r l u p u s , a n d if yo u h a ve a p o s it ive a n d yo u h a ve no s y mptoms, because there are v er y good cr it er ia to diag nose lu pus, then y ou're g onna g o f urther dow n, an d the y 're tr

y ing to see if y ou hav e any othe r ant ibod ies, aut o, —w e call it “ aut oan tibod ies” of imm unity, —auto ant ibod ies, w hich cou ld sugg est th at you have a conn ect tissue disease , and lupus is number one. Now , w hat is v er y par ti cul ar for all thes e medic ati ons, for t he Remi cade and for Imuran and Humi ra , al l of them, t hey are—t hey hav e a degree of

imm uno genicity , as he m ent ion [ s ic], ma ny time s. And you are gonna have this test po sitiv e, to o. 17—I think the num ber w ent a l ittle bit hig her , bec ause now they see more and more, about 19 percent of pati ents w ho are on thi s medi cat ion are g onna ha v e thi s p osi ti v e tes t for lup us. N ow w hen w e g o to doubl e- stranded DN A, b ecaus e I did that , t oo, s he had— but ithad no s ig nific ance. 20 percentof thes e pat ie n ts are g onna ha v e a posi ti v e and w e are g onna j ustw atc h and see w hat' s h appeni ng
. But, y ou know , as w e menti oned, w e k new thatthe lup us- li ke sy ndrome i s v er y rare, but you g et prepared for it

. Y o u g et your st uff there and y ou w atc h i t, becau se thi s i s w hat you need to do. At t hat p oin t, Dr . Po p- Mo ody pla nned to beg in w eani ng Patr ic ia off of her predni sone and to con tinue g iv ing her Remicad e treat me nts every tw o mo nth s. Patri cia had a thi rd R emic ade i nfusion under D r. Pop- Mo ody ’s ca re on J uly 10, 2002. She finis hed t aki ng predni sone on J uly 28, 2002. D r. Pop- Mo ody sa w her ag ain on22

August 9, 200 2. Dr. P o p -M ood y testif ied th at after stop ping the pre dniso ne, Patricia sta rt ed ex per ien ci ng more pai n i n her s houl ders, elb ow s, w ri st s, a n d hands. Dr . Po pMo ody ’s note s i ndi cat e tha t Pa tr ic ia was “v er y st iff in t he mor nin g and pretty
unco mfortab le[,] a nd a t night she has prob lem s sleep ing due to the pain .” Her note s also indicat e tha t “[t]he la bs don e on 6/2 7 showed a po sitiv e ANA an d an ti-[ds]DNA w as also posi ti v e at 35. She ha d nor mal compl ements a n d t h e E NAscreen w as w it hin nor mal limits.” Her notes sta te th at Pa tricia had “[p] ositive serology for SLE. ” Dr. Pop-Mood y

ex plaine d tha t the se testresults w ere no t eno ugh to diagno se Patr ic ia w it h lup us- li ke sy ndrome becau se acc ordin g to he r, tw enty percentof pati ents on Remi cade w il l tes t pos it iv e for AN A and doubl e- stranded D NA anti bodi es. D r. Pop- Mo ody presc ri bed a shotof kenal og i nst ead of predni sone and dec ide d to cont inu e R emic ade treatments ev er

y two months

. Patr ic ia had ano ther

R emic ade i nfusion on A ug ust28, 2002, and she s aw D r. PopMo ody on S eptember

20, 2002. D r. Pop- Mo ody t e sti fied Pat ri ci a had an "ex cel len t respo nse" to this treat me nt, b ut by the time ano the r treat me nt was due , Patricia w as again experiencing pain. Dr . Pop -Moody testif ied th at atthattime, she did no t forese e Pat ricia
ev er bei ng abl e to sto p treatment w it h R emic ade. Patr ic ia' s fifth Remi cade infusi on presc ri bed by D r. Pop- Mo ody

w as on October

14, 2002. At an off ic e v is it on Nov ember 15, 2 002, Patr ic ia re por ted t hat s he w as ex per ien ci ng a "flare of ar

thr it is al l ov er

for t he l astten day s. " Pa tr ici a t old D r. Pop- Mo ody thatthe Remi cade enabl ed her

to functi on full y

and nor mall y , buti t w as only ef fecti v e in c ontroll ing her ar thr it is pai n for a few

w eeks foll ow ing eac h treatme n t. At t hat t ime she w as experiencing neck p a in , s hou lder pain , and w rist and ha nd p ain w ith sw elling. H er hips,23

knees , ank les , and feet w ere v er y pai nful and s ti ff

. At t his poi nt, Dr . Po p- Mo ody dec ide d to i ncrease the d ose of Remi cade and decrease the int er v al betw een infusi ons. H er note s indicat e tha t she be liev ed that Patricia “fu nction s v eryw ell w ith this m edica tion[ ,] an d it is
w orth i t t o c hang e the sc hedul e of admin is trati on.” Patr ic ia‘ s s ixth R emic ade i nfusion under D r. Pop- Mo ody ’s ca re w as on N ov ember 25, 200 2, an d he r sev ent h inf usion w as on Janu ary9, 200 3. A t an of f ice v isit on Janu ary 17, 2 003, Patr ic ia 's joi nt pai n had improv ed. Howev er , Pa tr ic ia re por ted t hat s he had an
u p p e r re spirato ry

infection in the f irst part of Janu aryinv olvi ng a cough, fever, chest press ure, an d anot her

flare of join t pain. She had been admitted to the emerg ency room and w as dia g nosed w it h per ic ardit is

. Patr ic ia re por ted t hat a fter recei v ing R emic ade on Janua ry 9, her j oin t pain was m uch improv ed, a nd s he g enerall y felt bette r. D r. PopMood y ’s note s indicat e tha t she believed the “[a]cu te pericarditis [w as] most likelyv iral in nature. The re i s a p o ss ibi li ty of an aut oimmune per ic ardit is as w ell .” D r. Pop- Mo ody decid ed to contin ue th e Rem icade inf usion s. Dr. Pop-Mood y

saw Patricia again on Janu ary24, 2 0 03. At this time, Patricia
re p o rt e d fe e li n g fa t ig u e d a n d wa s e xp e ri e n c in g m o re sh o rt n e s s o f b re a t h t h a n p re vio u s ly. Dr. Pop-Mood y

note d tha t an ech oca rd io gram w as pe rforme d tha t showed a sma ll per ic ardia l eff usi on. Patr ic ia had s u f fered w eig ht l oss of tw elv e pound s. In her
ass ess ment, Dr . Po p- Mo ody note d tha t t he per ic ardit is w as “mos t l ik ely v iral in nature but in the p re senc e of di ag nosi s o f sarcoi dosi s[, ] a flare -u p o f this co ndi ti on s houl d be
cons ide re d too ev en th oug h the pati ent receiv e d i mmunosuppress ion and als o the Rem icade t reatm ent .” Dr. Po p-Mood y a gain p rescribed pred nison e, an d she saw Patricia ag ain on J anuar

y 31, 2002, to moni tor

her predni sone use.P l eu ri s y i s de fi ne d a s “[ i ] nfla m m a ti on of t he pl eu ra, t he l i ni ng s su rr ou nd i ng t he l un gs
. ” See 9 M e d i c i n e N e t.c o m , D e fin i ti o n o f P l e u ris y , ht t p: / / www . m edt er m s. com / s c r i p t/ m a i n / a r t

. a s p ? a r t i cl ekey =494 8 ( l ast vi s i t ed F eb

. 11 , 20 10 ). 24 On F ebr uar

y 20, 2003, Patr ic ia had an eig hth infusi on of R emic ade presc ri bed by Dr . Po p- Mo ody

. On M arch 27, 2 003, Patr ic ia cal led Dr. Pop-M oody ’s of fice to repor

t t hat she w as run nin g a hig h fev er and had pain all ov er

her body . At an off ic e v is iton A pr il 4, 2003, Patr ic ia ag ain co mplai ned of j oin t pai n i n her s houl ders, neck , w ri sts , han ds, and ankl es. Pa tr ic ia re por

ted hav ing a fev er of 10 2 deg re es and ches t pai n on th e l eft si de of her che st, w hich w as exacerbat ed b y breath ing and m oveme nt. Pa tric ia h a d see n Dr. She rron on March 31 , 200 3, w ho p erforme d an echo cardiogram a nd a chestx-ray. T here
w ere no si g ns of pl eur is y or per ic ardit is at that ti me. D r. Pop- Mo ody ’s as ses sment w as 9 that “t here [w as] a q uest ion betw een rheumat oid ar thr it is and enteropathi c a rt hr it is

. The pati ent h as posi ti v e s erolo g ies for r heumatoi d fa cto r[ ,] w hic h make s t he di ag nosi s o f rheu ma toid a rthritis more likely[,] but at the same time she has inf lam ma tory bowel disease
w hic h coul d p re s e n tt h e s a me w a y t o o
. ” A d d i t i o n a l l y , D r
. P o p - M o o d y ’ s n o t e s re fl e c t ed “[ p]os it iv e s erolo g y

for S LE w hic h c oul d be ind uced by Remi cade[ ,] but now there are oth er question s a bou t her developin g clinical lu pus in v iew of previ ous p ericarditis and the che st pain w hich she had recently w hich are h ighly sugg estive of

pleurisy.” Dr . P o p -Mo o d y test ified thatat that ti me, s he bel iev ed th at t he dev elo pment of lup us- li ke sy ndrome as soc iat ed w it h Remic ade w as an extremely rare s it uati on, a nd i t was “[l]ow on the dif

feren tial.” She sta ted thatbase d on the packa ge inse rt’s de scription of only three c a s e s of

lupus, she be liev ed it w as extreme ly unlikely tha t Patricia ha d lupu s-like sy ndrome. Ne vert h e le ss , Dr . P o p -Mo o d y’s n o te s in d ica te th a t s h e di sc u ss e d th e po ss ibi li ty25

of lupus -l ik e s y ndrome w it h Pat ri ci a: I discu ss e d w it h the pati ent a ll thes e pos si bil it ies [,] and w e mi g ht ne ed to sto p the R emic ade atthi s p oin t. Pos itive serol og y for l upus is not unusu al w it h the R emic ade[, ] but dev elo pin g sy mptoms of l upus w oul d i ndi cat e tha t the patie nt ha s the con dition and then the Rem icade i nf usion s w on’t b e so hel pful. At the pres ent moment, she doesn’ t w ant t o g iv e up the R emic ade infusi on bec ause she is feeli ng v er y w ell for about fiv e to si x w eeks after

the in f u s io n [ , ] a n d we d e c id e d t o go a h e a d wit h t h is in f u s io n [ , ] a n d a f t e r t h a twe reallyn eed t o w eigh t he advanta ges o r disa dvantages of a lpha in hibition in her ca se[ ,] and w e (me and the pati ent) need to make a joi nt deci si on abou t the future of her

treatment. Dr. Pop-Mood y

testif ied tha t she decid ed to run mo re la b w ork t o test Pat ricia’s ANA l evels and to look for “comp lem ent s,” w hich she explained w ere i mp ortan t to dia gnosing lupusli ke sy ndrome. She ex pla ine d that if the “c omplement s” go dow n and the d oubl e- stranded DN A g oes up, t hen s he woul d be w or ri ed. On Ap ril 7, 20 03, Pat ricia had a nint h inf usion of Remicad e un der Dr. Pop-Moo dy’s
care. Dr . Po p- Mo ody

recei v ed a cal l from Pat ri ci a on Apr il 21, 2003 , and Patr ic ia ask ed if sh e c oul d l ow er

her predni sone dosag e bec ause she w as feeli ng bette r. D r. Pop- Mo ody ag re ed, b ut on Apr il 23, 2 003, Patr ic ia came t o D r. Pop- Mo ody co mplai nin g of pai n i n her ches t w hen s he to ok a deep breath. Dr . Po p- Mo ody ’s note s i ndi cat e tha t s he recei v ed th e tes t resul ts from the lab wor k s he ordered ear li er i n Apr il : W it h the l astv is itI re peated a r heumatoi d factor [,] and sur pr is ing ly the rheu ma toid facto r is negative. Th e ANA pa nel show ed again a positive ANA and p o s i t i v e d o u b l e [ s t ra n d e d ] D N A a t a l o w e r t i t e r
. Th i s t i me i t w a s 28[, ] and t he pat ien t had a t it e r of more t han 35 one y ear ag o. Al so, the com plem ent s w ere w ithin no rmal limits. Dr. Pop-Mood y ’s assessm entand diagnosis in her no te s s h o w t h a tbythe en d of April 2003, she w as se rious ly co nsi der ing w hether

Pat ri ci a may

hav e SLE or

dr ug -i nduce d lupu s:26

I nf lam ma tory arthritis mo st likely ent erop ath ic arthritis. Initially we cons idere d r heumatoi d ar thr it is due to t he pos it iv ity of rh eumatoi d factor w hic h al most ex cl uded an enteropathi c a rt hr it is w hic h bel ong s t o the g ro up of seroneg ati v e s pondy loa rt hopothy w hic h are s uppos ed to be s eroneg ati v e. Ma ny ti mes w hen w e are deal ing w it h autoi mmune dis eases y ou can see the sw it chi ng of se ro lo g ies w it h the sa me cl ini cal co mplai nts

. The posi ti v ity of AN A and anti -D NA

w as cons ide re d up unti l now bei ng i nduce d by

TNF al pha therapy but in v iew

of the p er ic ardit is w hic h the pati ent h ad i n the month of Febr uar y , t he pos si bil ity

of SLE i s rais ed. There a re repor ts cas es [si c] to develop cl ini cal SLE meanw hil e the y are tak ing TNF al pha i nhi bit ion

. I d is c u s s e d wit h t h e p a t ie n te xt e n s ive ly a ll o f t h e s e p o s s ib il it ie s [ , ] a n d st il l we do nothav e a fir m di ag nosi s of lup us due to the fact th at t he ti me w hen s he had t he per ic ardit is sh e di d hav e s y mptoms of an upper respi ra tor

y i nfecti on. The pati ent i s a w are of the fact th at t he TNF al pha t herapy ca n ind u ce a lup us flare w hic h w e ha ve as an unde rl y ing co ndi ti on[,] but at t he present mo me nt she doe s not want to stop the Rem icade treatm ent b e cause this sta bil iz ed her

C ro hn’ s s y mptoms w h ich w ere v er y pronounc ed. She ha d re peated surg er ies done for i t[, ] and sh e does n o t wan t to retur n to that si tua t i o n a g a i n
. A l s o , t h e j o i n tp a i n s a n d s t i ffn e s s a re v e r y w e l l c o n t ro l led w it h Remic ade[, ] and this enabl es her to int eg ra te normal ly

i n her l ife s o s he is v er y relu cta nt t o s top t he medi cat ion es p eci all y i f I do no t hav e anythi ng els e to offe r h e r
. C o n s e q u e n t l y s h e i s g o i n g t o re a d mo re a b o u tSLE s ym p t o m s [ , ] a n d we wil l fo ll o w h e r ve ry c lo s e ly. Dr . Pop -Mo o d y t est ified thatsh e g av e Pat ri ci a l it erature on lup us and t hat P atr ic ia w as going to read it. She claime d tha t she advi sed Patricia of the sy mp to m s o f lu p u s -l ike sy ndrome, s uch as ra shes and “c hestpai ns w hic h c ome and g o, and theyhurt y ou w hen y ou take a d eep breath .” D r. Pop-Moo dy adm itted thatthe increa sed join t pain thatPatricia
ex per ien ced coul d be from dr ug -i nduce d l upus- li ke sy ndrome. Thomas re cal led that Patr ic ia came h ome from an appoi ntment w it h D r. Pop- Mo ody
w ith a pa mp hlet o n lupu s, and he stat ed th at Pa tricia “was sup pose d to go throu gh these lup us sy mptoms and dec ide w hether or not—or

to deci de w hether

or not she w as hav ing any of these sy mp tom s. Th is w ay, they could talk abo ut it next time th ey me t.” Patricia tes ti fied th at she rec all ed Dr . Pop-M oody di sc uss ing l upus w it h her i n the Spr ing of 2003, alt houg h s he di d notsp eci fy the e x actdate

. Howev er , Pa tr ic ia deni ed th at D r. Pop- Mo ody27

infor med her that the Remic ade coul d be caus ing dr ug -i nduce d l upus; sh e tes ti fied th at s he deci ded t o c onti nue on Remi cade becau se she bel iev ed, a t t hat t ime, thatR emic ade w as the o nly opti on to prov ide her

w it h any

reli ef. She tes ti fied t hat s he di d notkn ow that Remi cade w as the c ause of her probl ems atthatti me. Dr . Po p- Mo ody ’s note s, how ev er , w ere sent to Dr

. Sher ro n, and i n her anal y si s, she not ed th at Pa tricia w as con sidering legal action against Cento cor: I do no t know i f

y ou a re aw are tha t she is lookin g fo r le gal action against Cen tac or

[s ic]. The pat ien t w ants to hav e par t of her c o- pay

pai d by Cen tac or

[s ic] bec ause she thi nks thatsh e s tar ted h av in g t h e j oin t c om pl ai nt s s o pron ou nc ed o nl y aft er th e R em i c ad e w as g i v en to he r
. I n my opi nio n s he benefitt ed from Remi cade extremely due to the s tabi li z ing of her Cro h n ’s sym p t o m s a n d a ls o o f t h e j o in ts ym p t o m s b u twe a re i n a se n s it ive situat ion an d she has to t a k e t h e respon sibility to go ahea d w ith this treatment as lon g as w e hav e a sus pic ion of lupus and not to make any body respo nsible in case w e have mo re com plication s. I am not sure ho w she is going to reactto the se prob lem s but I w anty ou t o b e i n forme d ab outall the se de v elop me nts. Patr ic ia ex pla ine d tha t “ at t hat t ime m y u ndersta ndi ng w as I woul d be on th is dr ug ind efini tel y

and the R emic ade had actual ly ca used the f la re o f

rheumatoi d ar

thr it is thatI
w as now sufferin g from and hav ing to be treated w it h the same dr ug ." She bel iev ed th at she w oul d hav e to cont inu e R emic ade i ndefini tel y . On M ay 13, 2003, Patr ic ia had her tent h R emic ade i nfusion , fo ll ow ed by anot her inf usion on Jun e 10 , 200 3. On Jun e 27 , 200 3, Pa tricia saw D r. P o p -M o o d y . Patricia
re por ted t hat p ri or

to her i nfusion on J une 10, sh e ex per ien ced aches i n al most all of her joints an d ha d prolon ged stif f ness in the m orning. Patricia also com plaine d of shortne ss of breat h butno c hestpai n. Dr . Pop-M oody testi fied that at that ti me, th ere w as nothi ng ind ic ati ng to her

thatPat ri ci a had SLE o r dr ug -i nduce d l upus- li ke sy ndrome. Patr ic ia had t hree more R emic ade i nfusion s o n J uly 8, Aug ust5, and Se ptember28

2, 20 03. Dr . Pop-M oody ex amined Patri ci a after her i nfusion on S eptember 2. D r. PopMood y note d tha t the August inf usion o nly provided relief for tw o w eeks, and then Patricia had a big flare of jo int pai ns and sw ell ing in the s houl ders, hands , k nees, hi ps, and feet. Dr. Pop-Mood y ’s note s indicate tha tt h e “jo in t pain s are getting more an d mo re pronounc ed.” They

al so ind ic ate t hat D r. Pop- Mo ody dec id e d t o s top t he R emic ade therapy w hil e Patri ci a soug ht a sec ond opini on: “W e had an extens iv e disc uss ion about the s it uati on th at atthe present t im e t h ere i s n o us e for Remi cade any more.
. . . I am
re luctant to prov ide her w it h thi s medi cat ion any more w it hout hav ing a s econd opi nio n.” Dr. Pop-Mood y

testif ied th at by this time, Pa tricia's f lares of joint pain w ere becomi ng more i ntens e, an d the durati on of the re li ef peri ods follo w ing each treatment w as becomi ng sh orter

. Dr . Po p- Mo ody referred Pat ri ci a to a g ro up of phy sic ia n s a t the Uni v ersi ty

of Tex as Hea lt h Sc ien ce Cen ter i n H oust on for cons ult ati on and treatment. H. Th e H ou st on D oct ors O n S e p t e m b er 30, 2 003 , Patricia w entto the Univ ersityof Te x as Health Science Cen ter in Hou sto n and saw Ma ureen D. Ma y es, M. D. ; Noranna B. W ar ner , M. D. ; a nd Leslie W ilson, M.D. T hom as claime d tha t he f irst heard th e term “drug- indu ced lup us” in Hou sto n from D r. W ar ner
. Pat ri ci a tes ti fied th at i t w as not u nti l she w ent t o H oust on th at she dis cov ered th at t he R emic ade w as caus ing her probl ems. Dr . M ay es and D r. W il son w ro te a letter to Dr . Pop-M oody

on September

30 a fter seei ng Pat ri ci a. The doct ors made the follo w ing as ses sment: 1. Symme tric poly arthrit i s i nvol v i ng t he h an ds , elbow s, shou lders, kne es, and feet that coul d be cons is tent w it h lupus (potent ial ly dr ug -i nduce d by Rem icade ), althou gh the literatu re is limited in suppo rtiv e evidence of this enti ty

. The re hav e been sev eral stu die s s how ing thatthe p re s e n c e o f

d o u b le s t ra n d e d DN Aa n t ib o d ie s in p a t ie n t s wh o re c e ive“ Sar coi dosi s” i s scr at ched t hr ough on t he d ocum ent wi t h an i nk pen. W e ar e un abl e t o t el l f r om t he 10 r ecor d who scr at ched t hr ough t he wor d. 29

Remi cade is not uncommon; how ev er , t here hav e been li mite d c ases of lupus-like sy ndro me seen w ith this me dicatio n. T he p atien t, at th is ti me, does appear

to hav e a s y ndrome thatco u ld be c las si fied a syste micl upus er

y sth ematos us. The cl ini cal pict ure i s l ess co nsi ste nt w ith sarcoido sis or

ar thr it is assoc iat ed w it h s arcoi dosi s. The c li nic al [10] prese nta tion could be consiste nt w ith ent erop ath ic arthri t is

. This could be arth ritis associated w ith he pat itis C v irus. 2. Leuko peni a—pos si bly se conda ry

to lup us- li ke sy ndrome or a s ide effectof Imuran. .
. . T he d octo rs decided to discon tinue f urthe r treatm entw ith Rem icade be c a u se Pat ricia apparentl y

w as no long er

benef itti ng from i t. Ins tead, they presc ri bed i ncreased dos ag es of othe r m edica tions Pa tricia had ta ken o f f and on, includ ing prednison e. T he d octo rs pla nned t o foll ow

Pat ri ci a’s se ro log ies for the n e xt fewmonths to monit or her “ AN A, a nti dou ble stran ded DNA, and an ti histon e level.” At a se cond v is iton O cto ber 15, 2003, Patr ic ia 's co ndi ti on had improv ed. In a l etter to D r. Pop- Mo ody , t he H oust on doctors w ro te: T he p ati e n tp resen ted to our clinic for evaluation of possible lupus-like sy ndrome w hic h may

hav e been ind uced by R emic ade th erapy
. Upo n ev alu ati on by her rh eumatol og is t in Cor pus Chr is ti , the pati ent w as found to hav e a p osi ti v e AN A and posi ti v e doubl e- stranded D NA antibodi es. O ther si g nific ant his tor

y inc lud ed the epi sode of pe ri cardit is i n J anuar y of 2003 an d the p re senc e of le ukope nia ( absol ute l y mphopeni a) . Upon i nit ial present ati on to our

cl ini c a few

w eeks ag o, t he pati ent’ s p hy si cal ex am showed s ig nific ant tender ness on int er nal and exter nal rotati on of both of her shou l d e rs
. Th e re w a s a l s o s o me s w e l l i n g o f t h e fi n g e rs , p a rt i c u l a r l yi n the PIP joi nts bi lat erall y . There w as decreased hand g ri p s econd ar y to pai n. Today , t he pat ien t s tatesthatsh e i s much improv ed sinc e her prev iou s v is it

. She w as able to g o to the z oo earl ier thi s week and w as abl e to w alk around for approx imat ely

4 ho urs w it hout si g nific ant joi nt pain. She has res umed her dai ly acti vi ti es inc lud ing dress ing hersel f and car ing for h ersel f w it hout needi ng as si sta nce from her hus band. The pat ien t s tates thatsh e has no30

significan t mo rning stiff ness a t this time . She occa siona lly has som e pa in in her sh oul ders a nd uppe r extremit ies but feels that she is much improv ed si nce her

l astv is it

.

. . . . ASS ESS MENT: Sy mm etric polyarthritis i nvolv ing han ds, shoulde rs, knees, feet, w hic h i s c onsi ste nt w it h a lup us- li ke sy ndrome ( potent ial ly dr ug -i nduce d byR e mi c a d e )

. Th e p a t i e n t h a s i mp ro v e d o n a n i n c re a s e d d o s e o f I muran 150 mg dai ly , inc re ased from 100 mg dai ly

. The pati ent a ls o had inc re ased h e r p re d n is o n e d o s e f ro m 1 0 m g d a il y t o 1 5 m g d a il y. It w as un dispu ted thataf ter Pat ricia stoppe d takin g the Remicad e, her arthritis pain imp rov ed co mp letely. Patricia testif ied th at, h ad sh e kno w n tha t Re m ic a d e could cau se lup us- li ke sy ndrome, she w oul d hav e ask ed more q uest ion s before maki ng a deci si on to tak e R emic ade. I. Exp ertT est imo ny o n Pat rici a’s D iag no sis Dr . Er tan tes ti fied as an e x per t for Cen toc or
. He re v iewed th e not es from the Ho u s t o n d o c t o rs , a n d h e s t a t e d t h a t h e a gre e d wit h t h e m t h a t P a t ri c ia a p p e a re d t o h a ve lupu s-like sy ndro me . Additio nally, D r. O ls en was hired by Cento cor to provide expert tes ti mony , butsh e w as cal led by the pla int iffs to tes ti fy as an adv erse w it ness
. Dr . O ls en tes ti fied th at i t w as her

opi nio n tha t Pa tr ic ia had dr ug -i nduce d l upus. Sh e ex pla ine d: In te rms of

diagnosing a lupu s p resen tatio n, the re are certain clinical cr iteria tha t are use d. T hatinclude s sy mp tom s, sig ns, an d the n the re's laborat ory stu die s. In ter ms of dr ug -i nduce d, ob v iou sly, i t' s n ot on ly the dia g nosi s o f lupu s, butw het her the re w as a drug pre [sic] tha t set it of f . And th en o nce y ou remov e the of

fending drug sy mptoms g o aw ay
. And t hen t here c an be, in addi ti on, c e rt a in anti bodi es in dr ug -i nduce d l upus cal led "anti his tone ant ibod ies" th at are importa nt. So in term s of the ration ale fo r lupus—I'm still flipp ing throug h my

pag es, here. I mig ht ha v e i n thi s p arag ra ph new features , i ncl udi ng j oin t s w ell ing , pos it iv e AN A, p osi ti v e doubl e- stranded DN A, p osi ti v e ant ihi sto ne ant ibo dy , l eukop eni a, l y phoepeni a, rash, hi sto ry of oral ulcers, fever and seritosis w ith a pe ricardial ef f usion . All of th ose a re c li n ic a l fe a t u re s t h a tco u ld b e s u gge s t ive o f lu p u s , a n d a n t ih is t o n e a n t ib o d y, specif ically

drug-i ndu ced lup us. T here w as som e pleu ritic chest pain . Th ere31

can be s erosi ti s o r ple ur is y i n lupus . How ev er , s he di d hav e the co mpli cat ing his tory o f

sarc oid , s o one w it h g ood emphas is [woul d] k now w hether that coul d be sarcoi d or

l upus- re lat ed. But thos e w ere the rati onal e for that. Dr . O ls en te sti fied th at s he bel iev ed Pat ri ci a’s sy mptoms re v eal ed a dis cer nib le ca se of lup us- li ke sy ndrome i n J anuary 2003, w hen Pa tr ic ia dev elo ped per ic ardit is

. Dr . O ls en explained w hy she b elieved tha t w as a de term inative facto r: Beca use p rior to that, her joint complicat ions had certainly w orsen ed, but it w as no t clear-cut w hatthatw orsen ing was du e to. C e rt a in ly, rheum ato id arthr it is would h av e been an i nit ial co nsi derati on, b ecaus e s he di d hav e a bilate ral sy mm etric polyarticular sy novitis process, w hich is a classic fe atu re for r h e umatoi d. Cer

tai nly , i t c oul d hav e been enteropathi c a rt hr it is

. I find th at a l i tt l e l es s l i k el y , be c au s e of h er t rea tm en t of m ul ti pl e j oi nt s
. A nd s om e of t h e o t h e r sero logic feat ures, he r blood te st feat ures, he r painf ul ANA posi ti v ity , and [anti- ]ds DN A posi ti v ity , in the study of T NF bl ock er

us e c an be seen jus t al ong for t he r ide and not a ctu all y be pathog eni c, so thos e features sti ll don' t make y ou hav e to re ass ess the si tuati on. But a per ic ardia l eff usi on doe s g e t o n e ’ s a t t e n t i o n t o s a y , w e l l , w h a t c o u l d t h i s b e d u e t o ? I s i t an infect ion ? I s i t rela ted t o the ar thr it is ? Rarely in rh eumatoi d it can occ ur
. Is itrela ted t o per haps a dr ug -i nduce d lupus ? Y es, it coul d be seen in that. So one woul d hav e to be rethi nki ng i t atthatpoi nt. Dr . Ols en testi fied that she beli ev ed earl y on, Patr ic ia re cei v ed s ome reli ef f ro m the Remi cade, but lat er , as the p ain worsened , D r. Ol sen bel iev ed th at more of the re li ef w as comi ng from s teroid s. Ja mes W il d, M .D ., Dr . Bu ll en’ s e x per t w it ness w h o wa s c all ed as an adv erse w it ness by the Hami lt ons, tes ti fied th at a pati ent w ho recei v es st eroid s a nd Remi cade coul d bel iev e tha t t he reli ef she were get ti ng w as comi ng from t he R emic ade the rapy w hen , in fact, th e Rem icade w as ma king i t w orse. W hen asked if h e b e li e v ed if “i nformati on to a pa ti ent w ho has condi ti ons li ke Mrs. Ha mil ton had, t hat R emic ade t herapy coul d i nduce l upus, could hav e influenc ed—c oul d influenc e tha t pat ien t i n dec idi ng not to take the Rem icade ,” Dr . W ild state d, “Possib le, y es.” Davi d T rock, M. D. , an expert for the Ham iltons w ho was called as an a dverseW e n o te th a t a l th o u g h H a m i l to n fi l e d s u i t a g a i n s t C e n to c o r o n M a rc h 1 9 , 2 0 0 3 , s h e c o n ti n u e d to 11 ta k e i n fu s i o n s o f R e m i c a d e th ro u g h S e p te m b e r 2 , 2 0 0 3

.

T he Ham i l t ons a l so al l eged causes ofact i on f orneg l i ge nce, gr oss ne gl i gence, and 12 m i s re p re s e n ta ti o n
. 32 w it ness by

Centoc or , als o testi fied throu g h his depos it ion testi mony that he bel iev ed th at Patr ic ia develo p e d “syste micl upus
. . . i n the mid dle of 2002.” W hen as ked how to dis ti ng uis h s y ste micl upus from dr ug -i nduce d l upus and w hether Pat ri ci a had dr ug -i nduce d lup us- li ke sy ndrome, D r. Troc k e x pla ine d: W ell , a few thi ng s to cons ide r. [Pat ri ci a] did fulfill the 1982 A CRcr it er ia for lu p u s in th e yea r, ce rt a in ly in e a rly 20 0 3 . If it’ s ne ce ss a ry to d ist in gui sh dru gindu ced lup us f rom sy stem ic lup us the re a re a few things tha t are ordina rily done

. A n d one of them i s t o det er mine if there’s an o ffendi ng ag ent re spons ibl e, t o w it hdraw i t, and s ee w hat happens to the p ati ent. And as far a s I ’m a wa re o f

t h e r e c o rd , t h a t ’s wh a th a p p e n e d

. So sh e d id in d e e d h a ve lup us in probabl y

as earl y as mid 2002, and t he not ion of dr ug -i nduce d l upus alo ng the w ay
. I’ m not ex act ly sure wh e n b ut c ertai nly i n J anuar

y of ‘03 w hen she w as ad mitt ed to a hosp ital w ith pericarditis, to me it w as no more q uest ion

. The setti ng of the r ig ht s erolo g y , lyphopenia, l eukop eni a, an d per ic ardit is thatsh e at lea st had l upus, be i t drug -i nduce d or s y ste mic , atthat ti me it wasn ’tc le ar
. But in re trospect I woul d s ay thati t w as dr ug -i nduce d becau se the presenc e of hi sto ne anti bodi es and the cl ini cal im p ro v ement upon s toppi ng the offendi ng ag ent w hic h i n thi s c ase w as Remi cade. Dr. Trock the n stat ed th atit w as his opin ion th at Pa tricia had d rug-i ndu ced lup us, w hich manifest ed i tse lf physi cal ly i n Pat ri ci a by

the ar thr it icpai n s he ex per ien ced and t he per ic ardit is

. J. The Jury ’s Findings and the Judgment The Ha mil tons sued Cen toc or on Ma rc h 19, 2 003, and lat er named D r. H auptman, 11 Dr. P op- Mo ody , D r. Bul len , and D r. Bul len ’s i nfusion cl ini c a s d efendants. The pe ti ti on all eg ed th at C entoc or

co mmitt ed fraud, among other caus es of acti on. The Ha mil tons 12 all eg ed that Dr . Haupt man, Dr . Pop-M oody , and D r. Bul len fail ed to adeq uatel y w ar n herT h e ju r y a ls o f o u n d C e n to c o r lia b le f o r n e g l i g e n t m i s b r a n d in g , n e g lig e n t m a r k e tin g to P a tr ic ia ’s 13 doct or s, m i sr epr esent at i on t o Pat r i ci a’ s doct or s, and negl i gent under t aki ng. Because we aff i r m t he j udgm ent o n th e b a s is o fth e f r a u d f in d in g , w e d o n o t a d d r e s s th e o th e r c a u s e s o fa c tio n f o u n d b y th e ju r y.

D r
. Pop- M oody set t l ed wi t h t he H am i l t ons f or $50, 000, and D r
. H aupt m an se t t l ed f ora conf i dent i al 14 a m o u n t. 33 of the risks associate d w ith Rem icade and failed to obta in her informe d con s e n t to such treat me nt. Followi n g a jury trial, the trial court granted a directed v erdict in favor of Dr. Bul len and his i nfusion cl ini c. The jur y found that Cent ocor

w as li abl e for

f ra ud. It awarded Pa tr ic ia $1.2 mil li on

13 for pas t pai n and mental ang uis h, $1 mil li on for future pai n and mental ang uis h, $1 .1 mil li on for pastphy si cal impair ment, and $65,908.00 in past medic al care ex pense s. The jur y al so aw arded Thomas $50,000 .00 for l oss of cons orti um and house hol d s er v ic es. The jur y appor ti oned l iab il ity

for H amil ton’ s d amag es as follo w s: C ent o co r, 85% ; D r. PopMo ody , 10% ; and D r. H auptman, 5%. The j ur y found thatthe fraud wa s e st a b li shed by cl ear and conv inc ing ev ide nce, and itaw arded Pa tr ic ia $15 mi ll ion and Thomas $1 mi ll ion in ex emplar

y damag es for C entoc or ’s fraudul ent c onduct. Before entr

y of jud g ment, Drs. Hau ptman an d P o p -Mood y se ttl ed w it h the Hami lt ons, and the H am ilt o n s n on- sui ted t hose defendants. The t ri al cour t app li ed 14 settl ement c re dit s a nd appo rt ion ed respon si bil ity , ent ered j udg ment ag ain st Cen toc or base d on t h e f raud claim, an d awarded act ual an d pu nitive dama ges and inte rest, for a tota l aw ard of

$4,6 87, 461 .70 to Pat ricia a n d $12 0,8 33. 71 to Th om as against Cen toco r. The ju dg ment s tates thati n the alt er nati v e, the Hami lt ons shoul d recov er actual damag es under the v ar iou s o ther

theo ri es present ed to the jur y . This appeal ens ued. II. L E A RNE D I N TER M EDI A R Y D OCT RI NE34

W it hin i ts firs t, sec ond, thi rd , and fourt h i ss ues, C entoc or arg ues that the “ lea rn ed in t e rmed iary ” doct rine preclud es the Ham iltons’ recovery beca use, as a ma tter of la w, Cen toc or ’s w ar nin g s to Patr ic ia’ s phy si ci ans w ere adeq uate. Cen toc or arg ues that ithad
n o d u ty t o wa rn P a t ri c ia d ir e c t ly. Fo r t h e re a s o n s e xp la in e d b e lo w, we d is a gre e , a n d we
re cogn iz e an ex cept ion to the d oct ri ne w hen a dr ug manufacturer eng ag es in direct -t ocons umer adv erti si ng thatfraudul entl y tout s t he dr ug ’s eff ic acy w hil e fail ing to w ar n of

the risks. A . Ori gi ns of

t he “L earn ed In te rme di ary ” D oct rin e in T exas T he “learn ed int erme diary” doctrine in Te x as can be trace d ba ck to this Court’s opi nio n i n Gr

avi s v . Pa rk e- Dav is & C o., 502 S. W .2d 8 63, 8 69- 71 ( Tex . C iv . Ap p.–C or pus Chr is ti 1973, w ri t re f’d n.r .e.)

. In that cas e, the pla int iff had surg er y to cor re ct an i ntes ti nal obstru ct ion. Id. at 864- 65. She recei v ed a spi nal anes theti c for the surg er

y thatw as compos ed of a combi nati on of t hree dr ug s— nov ocai ne, dextrose, and ad re n ali ne—an d pentot hal so diu m. Id. The no v ocai ne and dextrose w ere m anufactured by W int hrop Laborator ies and Ster li ng D ru g C ompany ; t he adrenal ine w as manufactured by Par keDavi s and Comp any; and the pen toth al sodiu m w as ma nufactu red by Abbot t Lab orato ries. Id. at 865. Afte r the s urg er

y , t he pl ain ti ff

co uld not mov e her

l eg s, and s he s uffered from bla dder dy sfuncti on, phl ebi ti s of t he left leg , hig h blo od press ure, and other probl ems w it h her l ow er extremit ies

. Id. Sh e s ued W int hrop Labo ra tor ies , Ster li ng D ru g C ompany , and Par ke- Dav is , al leg ing thatthey w ere s tr ictl y

l iab le for her

i nju ri es. Id. at 864. T he trial cou rt g ra nted summar

y j udg ment for the defendants, and w e re v ersed the summar y j udg ment35

and remanded for

tr ial

. Id

. At t he c oncl usi on of the cas e i n c h ie f , the dr ug co mpanie s
mov ed for a di re cte d v erdict, w hic h the t ri al cour t g ra nted. Id. The pl ain ti ff then appeal ed to t his C our

t. Id. A doct or tes ti fied at tr ial that W int hrop Laborator ies inc lud ed a w ar n in g in its pack ag e ins ert for the n ov ocai ne. Id. at 866. T he packag e i nser t, w hic h w as direct ed at physicians, w arne d as follows: In i sol ated ins tanc es one or se v eral of the foll ow ing co m p lic a ti o ns or si de effect s may

be o bser

v ed dur ing or

after sp ina l anest hesi a. Cau da eq uin a and lu m b osac ra l cord c ompli cat ion s ( usual ly co nsi sti ng of arachno idi ti s a nd demeli niz ati on) [r ]es ult in los s or impai rment of mot or and senso ry f unct ion of

the sad dle area (bladd er, rectum ) and one or both legs. Thes e c o mp l i c a t i o n s h a v e o c c u r re d a ft e r t h e u s e o f m o s t , i f n o ta l l , s p ina l anest heti cs
. The lo ss or i mpair ment of moto r functi on may be p er manent, or partial recovery

may slowly

occur. Various e x plan ation s for such com plication s have been advanced , such as h y perse nsitivi ty or intolera nce to t he anes theti c a g ent w it h a resul tant my e lo lyti c o r neurotox iceffect ; pool ing or

rela ti v ely

hi g h c oncen trati ons of an e st h eti c s olu ti on around t he caud a e q u i n a a n d s p i n a l c o rd b e fo re d i ffu s i o n ; a n d a c c i d e n t a l i n j e c t i on of irritatin g ant iseptics or de tergents (as w hen sy ringes are incom plete ly clean sed o r w hen the am pule storage soluti o n ente rs a cracked am pule ). Hen ce, many

anes thes iol og is ts prefer t o aut ocl av e ampul es in order to d e st ro y ba ct e ria on th e exte rio r be fo re op e n in g. In an ar ti cl e on the h az ards of lumbar puncture[,] D ri pps and Vanda m (J .A.M .A. 147:111 8, N ov . 17, 1951) p oin ted o ut t hat p ro lon g ed and occ asi onal ly

per manent s ensor

y or motor ab nor mali ti es mayresul t from directtrauma to ner

v e roots w hen t he punct ure is per formed. In some of the re por ted cas es of ne urolo g ic seq uel ae itw as found that the d is tur bance w as due t o preex is ti ng di seas e of the v ertebral col umn or ce ntral ner

v ous syste m (for example , cord tum ors, ma lig nan t me tasta ses, m ultiple sclerosis). Id. at 866- 67. The pack ag e i nser

t furt her w ar ned: CONTRAI NDICATI ONS AND PRECAUTI ONS W ith the ex cept ion of

infection in or abou t t h e lum bar area and certain36

ser iou s dis eases of t he cent ra l ner v ous syste m or of t he lumba r vert e bral colum n, m ost ane sthe siologists co nside r th e followi ng co nditio ns to be only re lat iv e c ontrain dic ati ons. The de ci si on w hether or not to us e s pin al anest hesi a i n an ind iv idu al cas e depends on t he physi ci an's apprais al of the adv antag es as oppos ed to the ri sk and on hi s a bil ity

t o c ope w it h the compl ic ati ons that mayar is e. Id. at 867. On ap pea l, the pla intif

f argued tha t the trial court erred in g rantin g a directe d v erdict becau se the d ru g co mpanie s fai led to w ar n her of a pos si ble i nju ry , ev e n t h o u gh the producti tse lf w as not d efecti v e. Id. at 869. W e hel d that the dr ug co mpanie s h av e a d uty to w ar n ab ou t da ng ers a nd r i s k s a s s oc i at ed w i th t he u s e of t he i r p rod ucts , bu t th att heir duty can be sat is fied by w ar nin g phy si ci ans, w ho are “l ear ned int er mediar ies ” betw een t he dr ug co mpany

and the p ati ent: Anot h e r questio n before us i s w hether the manufacturer

w as re q uired to w ar n M rs . G ra v is of the d ang ers i n the dr ug s. T he broc hure ac company ing the a mpules of nov ocai ne g av e the m e d ica l personne l inv olv ed det ail ed ins tr uct ion s and w ar nin g s c oncer nin g the handl ing and admini strati on of the d ru g. T h e wa rn in gs we re d ir e c t e d t o t h e a t t e n d in g p h ys ic ia n
. W e b e li e ve th a t itw a s u n re a so n a b le to su p p o se th a t a dru g ma n u fa ct u re r m u stgo bey ond t he physi cia n a n d g iv e actual w ar nin g s t o the pati ent. Onc e the phy si ci an has been w ar ned, the c hoi ce of w hic h dr ug s t o us e, an d the duty to ex pla in the r is ks i nv olv ed, i s h is

. Th e se d ru g s were manufactured for adm inistrat io n o nly by a ph y sician or oth er auth oriz ed p erson . Gene rally spea king, onlya physician would und erstan d the prop ensitie s and dan gers inv olv ed. The doct or

i s a l ear ned i nter mediar y between t he manufactu re r and t he ul ti mate c onsumer
. If the do cto r has been proper ly w ar n e d o f the poss ibl e s ide ef

fects, then w e beli ev e i t i s h is duty to conv ey

thi s war nin g on to t he pat ien t c ompati b le wit h s uch a reason abl e di sc los ure as the law impos es. See K

ar p v . C ooley, 349 F . Su pp. 8 27 ( S.D . Tex . 197 2) and author it ies cite d t h erein

. In t he Cooley c as e i t w as s ug g es te d th ats om e dis cl osures mayso di stu rb the pati ent [ that] theys e rve a s a hi ndrance to needed treatment. See al so Hal l v. United S tates , 136 F. Sup p. 187 (W .D. La. 195 5). I n t h is ca s e , t h e p h ys ic ia n , t h e a n e s t h e t is t , a n d t h e h o s p it a l h a ve settl ed w it h the pl ain ti ff i n anoth e r la w sui t. The q uest ion i s mootas to w het her the specif ic doct or or oth ers brea ched the ir duty to w arn Mrs. Grav is.I n t wo pr i orcases, t he T exas Supr em e Cour t hel d t hat a dr ug m anuf act ur ercoul d be l i abl e f or 15 i n ju rie s w h e re i t m i s re p re s e n te d to o r fa i l e d to p ro p e rlyw a rn p h y s i c i a n s o f a r i s k a s s o c i a te d w i th a d ru g
. See Br ist ol
- M yer

s C o. v. G onz ales , 5 6 1 S .W .2 d 8 0 1 , 8 0 4 (T e x . 1 9 7 8 ); C rocker v. W inthr

op L abs. , D i v. of

St er ling D rug, I nc. , 514 S. W

. 2d 4 29, 433 ( T ex. 197 4)

. T hose cases, however , di d not expr essl y st at e orapp l y what l at er becam e k nown as t he “ l ear ned i nt er m edi ar y ” doct r i ne, whi ch, as we expl ai ned i n G r a v is , al l ows a d r ug m a n u fa c tu re r to s a ti s fy i ts d u tyto w a rn th e u l ti m a te c o n s u m e r b y w a rn in g p h y s i c i a n s
. See G r avis v. Par ke- D avis & C o. , 50 2 S

. W

. 2d 86 3, 87 0 (T ex
. C i v. A pp
. –C orp us C hri s t i 19 73 , w ri t ref' d n

. r. e.)

. 37 W e ho ld th a t itis u n re a so n a b le to de m a n d th a t t h e m a n u fa ct u re r of dru gs spec ifica lly w ar n eac h and ev er y pati ent t hat recei v es dr ug s p re sc ri bed by the p hy si ci an or

othe r author ized p ersons
. The enti re syste m of drug dis tr ibu ti on i n Amer ic a i s s et up so as to pla ce th e respon si bil ity of dis tr ibu ti on and use upon professi onal p e o p le

. The la w s a nd reg ula ti ons prev ent p re sc ri pti on ty pe drug s f ro m bei ng purch ased by indi v idu als w it hout the advice, g uida nce a nd co nsen t of licensed physici ans a nd p harm acists. These professi onal s a re i n the best posi ti on to eva lua te the w ar nin g s p ut ou t by the drug i ndu stry . Our holding in n o w ay relieve[s] t he d rug compa ny in the ir duty to w arn or to provide a prod uct f ree of defects. Id. at 87 0. The Tex as Supreme Cour t f irst ack now led g ed the “le ar ned inter mediar y ” doct ri ne in Al m v. Alum inu m Co. of A m ., 717 S .W .2d 5 88, 5 91-9 2 (Te x . 198 6). In thatcase, Alm 15
w as inj ur ed w h e n a b o t t l e c a p e x p l o d e d o ff o f a 7
- U p b o t t l e , h i t t i n g h i m i n t h e fa c e and inj ur ing hi s e y e. Id. at 590. Aluminu m Compan y of Amer ic a ( “A lc oa” ) had manufact ured a bottl e- cappi ng machi ne and sol d i t t o JFW Enterp ri ses ( “J FW ”) , w ho us ed th e mach ine to cap s oda bottl es. Id. a t 5 8 9

. A l c o a w a r n e d J F W t h a t a b l o w - o ff c o u l d oc cur i f the cl osure w as improper

or the g las sw are w as not t o s p e cif icati on, b ut i t di d notw ar n of personal i nju ri es, and JF W di d notw ar n c onsumers a bout the p oss ibi li ty of inj ur ies

. Id. at 593. Al m sued Al coa, and Al coa arg ued t hat i t ha d r e lie d o n JFW to w ar n the ul ti mate
cons umers
. Id. at 591. Rel y ing on Gravis and federal cas e l aw , t he Tex as Supreme Cour t rec og niz ed th at in som e circumst ance s, a ma nufactu rer of a produ ct ma y

rely on an interm edia ry to pa ss38

alo ng a war nin g to the u lt imat e c onsumer : W e ag re e tha t a manufacturer or suppl ier may , in cer

tai n si tuati ons, depend o n a n i nter mediar

y t o c o mm u n i c a t e a w a r n i n g t o t h e u l t i ma t e u s e r o f a prod uct. Howev er, the mere presen ce of an interm edia ry

d oes notex cuse the manu facturer

from w ar nin g thos e w hom i t shoul d re asona bly ex pectto be enda ng ered by

the use of its product

. The is sue in ev er y ca se is w hether the orig inal ma nufactu rer has a r easo nab le assuran ce tha t its w arning w ill re ach thos e endan g ered by the use of its product

. In s ome si tuati ons, co urts hav e recog niz ed th at a w ar nin g to an int er mediar

y fulfil ls a s uppl ier's duty to w ar n ul timate c onsumers. F or ex ample, w hen a dr ug manufacturer proper ly w ar ns a presc ri bin g physi ci an of the dang erous propens it ies of it s p ro duct , t he manufactu re r is ex cus ed f rom warning each patie nt w ho rece ive s t he d rug. T he d octo r stands a s a learne d inte rmed iary

b etween the m anu factu rer a nd the ultima te con sum er. Generall y , onl y

the doct or

co uld understa nd th e pro p e n si ti es and dan gers i nvolv ed in th e use of a giv en drug. In this situa tion, it is reaso nab le for the ma nufactu rer to rely on the i nte rmed iary to pass o n it s wa rnings. How ever, ev en in th ese circum stan ces, w hen the w arning to the interm edia ry is i n a d e q u a t e o r

m i s l e a d i n g , t h e m a n u fa c t u re r re ma i n s l i a b l e fo r

i nju ri es sus tai ned by

the ult imat e us er
. Id. at 591 -92 (citation s omitt ed). As the s upreme co urt ex pla ine d i n Al m , a dr ug manufacturer has a duty to war n the ult imat e c onsumers o f its product s a bout dang e rs a ss oci ated w it h the product s, and t he “l ear ned int er mediar

y ” doct ri ne is merel y a means of s how ing that the dr ug company compl ied w it h i ts duty

. Wy e t h
- A y e r s t L a b s
. C o
. v

. Me d r a n o, 2 8 S

. W

. 3 d 8 7 , 9 1 (T e x. Ap p. –Te x ar k an a 20 00 , no p et .)( “ The l ea r ne d i nt er me diary do c tr i ne s ta te s t ha t, i n s om e si tuati ons, a war nin g to an i nter mediar y fulfil ls a s uppl ier's du ty to w ar n ul ti mate
co n su m e rs. ”) (ci ti n g Alm , 717 S.W .2d at 591)

. Thus, to the extent that Cen toc or arg ues that itow ed no duty

to Patricia , i t mi sc onst ru es the l aw
. The duty to w ar n the ul ti mate
cons umer w as alway s t here—t he onl y q uest ion i s w h e ther

C entoc or

ca n rely

on i ts adeq uate w a rn ing s t o physi ci ans to s ati sfythatduty w hen i t di re ctl y

adv erti ses to the39

pati ent i n a mi sl eadi ng fashi on. To unde rst a n d the answer to that q uest ion , w e ex amine the t heoreti cal und erpinn ings of

the “learne d inte rmed iary ” doct rine and its recogniz ed e x cept ions, a s w ell
as the c ur re nt l andsc ape of medi cal treatment and direc t- to -cons umer adv erti si ng , t o det ermin e if

the con cerns giv ing r ise to the “learned in term edia ry ” doctrine rem ain app licable w hen a drug man ufactu rer directly marke ts its produ cts to con sum ers. B. The Theoretica l Underpinnings of t he Doctrine From the cas e l aw , w e c a n gl e an s ev eral ra ti onal es for appl y ing the “l ear ned int er mediar

y doctr ine

. Fi rs t, cour

ts hav e hel d tha t t he c hoi ce of w hic h dr ug s t o presc ri be proper ly bel ong s to t h e doctor bec ause presc ri pti on dr ug s a re manufactured for admini strati on onl y

by a ph ysi ci an or

othe r author iz ed person. Gravis , 502 S.W .2d a t 870

. W e hel d i n Gravis that “[ t]he enti re sy ste m of drug di str ibu ti on i n Amer ic a i s s et up so as to place the respon sibility of distribution and use up on p rofession al peo ple.” Id. Beca use onl y a do ctor ca n p re sc ri be medi ci ne, t he arg ument g oes, a do cto r shoul d recei v e the
w ar nin g and pass i t al ong to his or her pati ents

. Id. Seco nd, Tex as cour

ts hav e hel d tha t “ onl y a ph y si ci an woul d understa nd th e prop ensitie s and dan gers i nvolv ed. ” Id. ; see Alm , 717 S.W .2d a t 592

. This speci al st andard for presc ri pti on drug s is an understa ndabl e ex cept ion to th e Resta tem ent 's g ene ral rule th at on e w ho m arkets good s mustw arn forese eabl e ulti mate users of dang ers inherent in his products. Pres cr ipt ion drugs are likely t o be comp lex me dicines, esote ric i n formu la and v aried in effect

. As a medic al ex per t, the p re sc ri bin g physi ci an c an ta ke int o ac count the prope nsities of

t he drug, as w ell as the su scept ibilities of his patien t. His is the tas k o f w eig hin g the benefits of any medi cat ion agai nsti ts potent ial dang ers. The choi ce he makes is an infor med one, an i ndi v idu ali z ed medi cal jud g ment bottomed on a k now led g e of both pati ent a nd pal li ati v e.40

Me dr ano , 2 8 S .W .3 d a t 9 1 (quo ti n g Reyes v. W yeth Lab s. , 498 F.2d 12 64, 127 6 (5th Cir. 1974) ); see Patr ic k C ohoon, An An swer to the Q uest

ionof W hy the T im e H a s Co meto Abr ogate the L ear

ned Inter m edi ar y R ulei n theCase of D ir

ect -to- Con sum er

Adv er ti si ng of Pr escri pti on D rugs , 42 S. T EX
. L. R EV
. 1333, 1336 ( 2001)

. Third, c our

ts around the count ry hav e been re luctant to int er fere w it h the physi ci anpati ent rela ti onship by

req uir ing a di re ct w ar nin g from t he manufactu re r to t he pat ien t becau se w ar nin g s t hat c ontradi ct the a dv ic e g iv en by a ph ys ic ian may

under mine the pati ent’ s c onfidenc e i n the physi ci an. See Lars N oah, Thi s is Your Pr

oducts L ia b ility Res tatem ent O n D rugs , 74 B ROO K
. L. R EV
. 839, 891 ( 2009) ; C ohoon, 42 S. T EX
. L. R EV . at 1336. This C our

t recog niz ed i n Gravis that some dis cl osures may so dis tur b pat ien ts that they may hi nder needed treatment. Gravis , 502 S.W .2d a t 870

. Fourth , it has be en a ssum ed th at do ctors are in a b ette r position to w arn the ir pati ents than the dr ug manufacturers, w ho ty pic all y d o n o t h a v e effect iv e means to communi cat e w it h the pati ents

. Noa h, 74 B ROO K
. L. R EV
. at 89 1- 92; C ohoon, 42 S. T EX
. L. R EV . at1336. “ Fi nal ly , bec ause of t he compl ex ity of r is k i nformati on abou t presc ri pti on dr ug s, comprehens ion probl ems woul d c ompli cat e any effort by m anufacturers to transl ate phy si ci an l abel ing for l ay pati ents .” N oah, 74 B ROO K
. L. R EV
. at 89 2; see Coh oon, 42 S. T EX
. L. R EV . at1336- 37. C. Reco g n i z ed Exc eptions and the Restateme nt ( Third) of Torts: Products Liabili ty Ov er the y ears, v ar iou s c our ts hav e recog niz ed e x cept ion s t o the l ear ned int er mediar

y doctr ine i n c ertai n s etti ng s, w here the abov e premis es under ly ing the doct ri ne did not appl y . For

ex ample, as earl y

as 1968, the Ni nth C ircui t hel d tha t t he manufactu re rI n 1986, howev er , t he Nat i onal C hi l dhood Vacci nat i on Act was pa ssed, whi ch r ej ect ed t he “ m ass 16 i m m uni z at i on” excep t i on t o t he l ear ned i nt er m edi ar y doct r i ne wi t h r espect t o m anuf act ur er s of chi l dhood v a c c i n e s b e c a u s e o f th e “ s u p p o s e d r i s k to m a n u fa c tu re rs .” P a tri c k C o h o o n , An Answ er t o the Q uestion o f W hy the Tim e Has C om e t o Abr ogat e the L ear

ned I nt er

m ediar y R ule i n the C as e of

D irect
- t o- C onsum er Advertising o f

Prescr i ption Drugs , 4 2 S. T EX
. L. R EV
. 1 3 3 3 , 1 3 3 8 (2 0 0 1 ) (c i ti n g 4 2 U .S .C

. § 3 0 0 a a -2 2 (c )) ; see also I n r e Sw ine Fl u I m m uni

z ation Pr

ogr am , 5 3 3 F . S u p p . 7 0 3 , 7 1 7 ( D . U ta h 1 9 8 2 ) ( d is c u s s in g th e S w in e F lu Act and t hat i t re s ul t ed because dr ug m anuf act ur er s r ef used t o sel l swi ne- f l u v acci nat i ons u nl ess t he go vern m en t provi de d l i ab i l i t y protec t i on ). 41 of a polio vaccine retain ed a duty t o w arn the ultima te con sum er beca use in th e ma ss immuni z ati on c li nic s w here the vac ci ne w as admini ste re d, a phy si ci an w as not pres ent t o
w eig h the ris ks and benefits of the d ru g for e ach pati ent. See Davis v. W yeth Lab s., Inc. , 3 9 9 F

. 2 d 1 2 1 , 1 3 1 ( 9 t h C i r
. 1 9 68) ; se e a lso R eyes , 498 F .2d a t 127 6- 78; cf. Hurley v. Lederle Lab s. Div. o f Am

. Cyana m id, Inc. , 863 F. 2d 1173, 1178- 79 (5 th Ci r. 1984)( hol din g lea rn ed i nter mediar

y theo ry appl ied i n case inv olv ing DPT v acc ine , w hic h w as presc ri bed and adm inistered und er supe rv ision of physici an). 16 Addi ti onal ly , sev eral cour ts hav e re cog niz ed an ex cept ion to the “learn ed int er mediar

y ” doct ri ne i n oral cont ra cept iv es cas es. These c ases reason that : (1 ) pati ents take contrace ptives as a mat ter of choice; (2) patie n ts person ally select the ir cont ra cept iv es; ( 3) physi ci ans pla y a reduce d role in the decis ion -mak ing proce ss ; and ( 4) often, th ese dr ug s are mark eted direct ly to cons umers w it hout communi cat ing the har mf ul si de effect s i n a mean ing ful w ay
. See, e.g., Odgers v. Orth o Phar

m s. Cor p. , 609 F . Su pp. 867, 872 (E.D . Mi ch. 1985) ; Stephe ns v. G.D . Se ar le & C o. , 602 F. Sup p. 37 9, 38 2 (E.D. Mi ch. 1985) ; Ma cDo nald v . O rt ho Pha rm s. Cor

p. , 475 N .E.2 d 65, 74 ( Ma ss . 198 5) ; see als o Coh oon, 42 S. T EX
. L. R EV
. at 13 37- 38. I n o the r words, in situa tions where an exceptio n to th e “learne d inte rmed ia ry” doct ri ne hasbeen re cog niz ed, c our ts hav e focus ed on (1 ) the e xtent to w hic h the doctor42

is i nv olv ed i n the dec is ion -mak ing proces s a nd th e s ele cti on of t h e d ru g i tse lf; and ( 2)
w hether there is a reason abl e l ik eli hood t hat war nin g s w il l be adeq uatel y co nv ey ed to the pati ent. The Amer ic an Law Ins ti tute re cog niz ed th is trend i n the ca se law w hen i t ado pted
s e c t io n 6 (d ) o f

t h e Re s t a t e m e n t(T h ird ) o f T o rt s : Pro d u c t s L ia b il it y: (d ) A p re sc rip ti on dr ug or medic al dev ic e is not re asona bly safe due t o ina deq uate ins tr uct ion s o r w ar nin g s i f reas onabl e i nst ru cti ons or w ar nin g s reg ardin g fores eeabl e r is ks of har m are notprov ide d to: ( 1 ) pr esc ri bin g and othe r h e a l t h
- c a re p ro v i d e rs w ho are i n a posi ti on to reduce the ri sk s o f harm i n ac cordance w it h the ins tr uct ion s o r w ar nin g s; or (2) the patient

w h e n t h e m a n u f

a c tu r e r k n o ws o r h a s r e a s o n to know t hat h e a lth -car

e pr ovi der s wi ll not be i

n a p ositi

on to re duce the ri

sk s of harmin ac cor

dancewit

h thei nst ru cti ons or wa rnings. R E S TA TE ME NT (T HI RD ) OF T O RT S : P R OD U C T S L I A B I LIT Y § 6( d) ( 1997) ( emphasi s a dded)

. As the c omments ex plain, se cti on 6( d) (1 ) re flect s t he tradi ti onal “ lea rn ed int er mediar

y ” doct ri ne, w hil e secti on 6(d) (2 ) recog niz es that dr ug manufacturers retai n a duty to w ar n the co nsumer

w hen t he phy si ci an’ s ro le in ev alu ati ng and maki ng a de ci si on
as to t he c hoi ce of drug i s d imi nis hed:

The obl ig ati on of a manufacturer to w ar n aboutr is ks att endant to t he use of drug s a nd medi cal dev ic es that mayb e s o ld o n ly pursuantto a h e a lt h -ca re pro vide r's pre sc rip ti o n tra d it io n a lly ha s re qui re d w a rn i n gs d ire cted to hea lth-care providers and not to patie nts. T he ratio nale supp orting this "learn ed int erme diary" rule is t hatonly hea lth-care profession als are in a po sition to und e rs t a nd th e significa nce o f the risks inv olv ed and t o as ses s t he rela ti v e adv antag es and di sadv antag es of a g iv en form of presc ri pti on- based therapy . The du ty then dev olv es on th e heal th- care prov ide r to s uppl y to the p ati ent s uch infor mati on as i s d eemed appropr iat e under

the ci rc umstan ces s o t h at t he pat ien t c an mak e an infor med ch oic e as to therapy . Su bsecti on ( d) (1 ) re tai ns the "l ear ned int er mediar

y " r ule

. Howev er , in cer tai n li mite d therapeuti c rela ti onshi ps the phy si ci an or

othe r heal th- care prov ide r has a much -d imi nis hed role as an ev alu ator

or dec is ion maker

. In t h e se i n st ances i t may be a ppropr iat e to43

impos e on the manu facturer the duty to w ar n the pati ent d irect ly

. Id. cm t

. b

. T h e c o m m e n t s f u rt h e r re c o gn ize t h e e xc e p t io n s t o t h e “l e a rn e d in t e rm e d ia ry” d o c t ri n e t h a th a ve d e ve lo p e d in t h e ca s e la w: W ar nin g s a nd i nst ru cti ons w it h reg ard to dr ug s or medic al dev ic es that can be s old l eg all y

onl y pursuantto a presc ri pti on are, un der the “ lea rn ed int er mediar

y ” ru le, di re cte d to hea lt h -care prov ide rs
. Subs ect ion ( d) (2 ) re cog niz es that direct w ar nin g s and i nst ru cti ons to pa ti ents are w ar ra nted for dr ug s t hat a re di spens ed or admi nis tered to pa ti e n ts w it hout the p ersonal int er v enti on or

ev alu ati on of a hea lt h- care prov ide r. An ex ample is the admini strati on of a v acc ine i n cli nic s w here mass i nocul ati ons are per formed. In many su ch prog ra ms, heal th- care prov ide rs are noti n a p o siti on to ev alu ate t he r is ks attendant upon use of the drug or dev ic e or to rel ate t hem to pati ents

. W hen a manufacturer suppl ies presc ri pti on dr ug s for di str ibu ti on to pa ti ents i n th is typ e o f unsuper v is ed env ironment, if a di re ct w ar nin g to pati ents i s feasi ble and can be effect iv e, the law re q uires measures to t hat effect

. Id. cmt . e. Commente t o secti on 6 furthe r ex pla ins thatthe Amer ic an Law Ins ti tute re cog niz ed the arg ument that w hen a dr ug m anufacturer direct ly adv erti ses to cons umers , i t has a du ty to w ar n the consumer

of dangers inherent in the dr ug ’s us e. Id. T he In stitute , howev er, d e t e rm in e d itb e s tt o le a ve t h e is s u e t o t h e d e ve lo p in g c a s e la w: Al thoug h the l ear ned i nter mediar y r ule i s g enerall y

ac cept ed and a dr ug manufacturer

fulfil ls i ts leg al obl ig ati on to w ar n by prov idi ng adeq uate w ar nin g s t o the heal th- care p ro v ide r, arg uments hav e been adv anced that in tw o o t h e r a re a s c o u rt s s h o u l d c o n s i d e r i mp o s i n g t o rt l i a b i l i tyon d ru g manufacturers that fail to prov ide di re ct w ar nin g s t o c onsumers. In the first, g ov er nmental reg ula tor y agenc ies hav e mandated that patien ts be i nformed of risks atte nda nt to the u s e o f a drug. A noted ex am ple is the FDA re qu ir e m e n tt h a tb i rt h co n t ro l p il ls b e so ld t o p a t ie n t s a c c o m p a n ie d b y a pati e n t pac kag e i nser

t. In the s econd , manufact urers h av e adv erti sed a presc ri pti on dr ug and it s i ndi cat ed u se i n the mass medi a. Gov er nmental re g ula ti ons re q uire tha t, w hen dr ug s a re so adv erti sed, they mustbe acc o mp a n i e d b y

a p p ro p r i a t e i n fo r ma t i o n c o n c e r n i n g r i s ks o a s t o p ro v ide bal anced adv erti si ng
. The q uest ion in both ins tanc es is w hether adeq uate w ar nin g s t o the a p p ro pr iat e heal th- care prov ide r shoul d i nsul ate t he m a n u fa c t u re r f ro m t o rtli a b il it y.E f f e c tiv e S e p te m b e r 1 , 2 0 0 3 , t h e T e x a s L e g is la tu r e a d o p te d s e c tio n 8 2 .0 0 7 o fth e T e x a s C iv il 17 Pr act i ce an d Rem edi es Code, whi ch cr eated a re bu t t abl e pr esum pt i on t hat a war ni ng a ccom pany i ng a p re s c rip ti o n d ru g “i n i ts d i s tri b u ti o n ” i s a d e q u a te i f i t i s a p p ro v e d b y th e F D A

. T EX
. C IV
. P RAC
. & R EM
. C OD E A NN
. § 8 2 .0 0 7 ( V e r n o n 2 0 0 5 ) . T h is s ta tu te b e c a m e e ff e c tiv e a fte r th is s u it w a s f ile d a n d is n o t r e tr o a c tiv e in i t s app l i cat i on; t hus, i t has no a ppl i cat i on t o t hi s case. Act of June 11, 2003, 78t h Le g. , R

. S. , ch. 204 , § 23. 02, 2003 T EX
. S ESS
. L AW S E RV
. 898- 99 ( 2003)

. M or eov er , i t i s not cl eart hat t hi s st at ut e was i nt ended t o cov er s om ethi ng ot he r t ha n a pa c k ag e i ns ert , w hi c h a c c om pa ni es a p res c ri pti on drug “i n i t s di s t ri bu t i on , ” and t he re wa s no e v i de nc e pr es en t ed a t t r i al t ha t t he v i de o sh ow n t o Pat r i ci a wa s ev era pp r ov ed b y t he FDA. 44 T hose w ho a ssert the nee d for a dequa te w arnings directlyto consu me rs cont end thatma n u factu rers that com mu nicate directly w ith con sum ers shoul d notes cape li abi li ty si mply becau se the deci si on to presc ri be the d ru g w as ma de by

the heal th- care prov ide r. Proponent s o f the l ear ned int er mediar

y r ule arg ue th a t, notw it hst andi ng di re ct communi cat ion s t o the cons umer, drug s cannotbe dis pense d unles s a heal th- care prov ide r makes an ind iv idu ali z ed deci si on that a dr ug is appropr iat e for a par ti cul ar pati ent, and t hat i t i s for t he heal th- care prov ide r to de ci de w hic h r is ks are rele v ant to t he par

ti cul ar pati ent. The I nstitute l eav es to de v elo pin g ca se law w hether ex cept ion s t o the l ear ned i nter mediar y r ule in t h e se or

othe r si tuati ons shoul d be re cog niz ed. Id. Th u s , th e In s t i t u t e r e fu s e d to ta k e a po s i t i o n on di re c t
- ma r k e t i n g cl a i ms an d h a s l e ft 17 itup t o c our

ts, su ch as ours, to resol v e the i ss ue, w hic h w e do next. D. Ch ang es in Ph arm aceu ti cal Advert isin g and t he Pro v isio n of H ealt hcare W hen the “learne d inte rmed iary ” doct rine w as f irst develope d, drug ma nufactu rers did not adv erti se to t he g eneral publ ic

. Sta te ex. Rel. John son & Jo hnso n Co. v. Karl , 647 S.E. 2d 899, 907 (W . Va . 200 7) ( ci ti ng F ra nci s B . Pa lumbo & C . Dani el Mu ll ins , The Dev elopm ent o f D ir

ect -to- Con sum er

Pr escri pti on D rug Adve rt

ising R egul ati on , 57 F OOD & D RUG L.J. 4 2 2 , 4 2 4 ( 2 0 0 2 ) ; O z l e m A

. B o rd es, The Lear ned Inter

m edi ar y D oct ri ne and Di re ct- to- Con sum er

Adv er ti si ng: Should thePhar

m aceutica l Ma nufac tur er Be Shielded fr omLi abi lity, 81 U. D ET
. M E R C Y L. R EV
. 267, 274- 75 (S pr ing 2004) ). “ Si g nific ant c hang es in the drug i ndu stry have post -date d the ado ption of the learne d interm edia ry doct rine in the majo rity

of state s in w hich it is fo llow ed. ” Id

. In p a rt i c u la r, t h o s e ch a n ge s h a ve45

inc lud ed “ the i nit iat ion and i ntens e proli ferati on of di re ct- to- cons umer adv erti si ng , al ong
w ith its impa ct on th e ph y sician/p atien t relation ship . . . .” Id. The f irs t dr ug manufacturer to adv erti se direct ly

to cons umers w as Upj ohn Co m p a n y , w hen i t adv erti sed for th e men’ s h air-l oss treatment, R og ain e. SeeJon D. Han son & D oug las A. Ky sar , Tak ing Behavi or ali smSeri ousl y: Som e Ev

ide nce of M

ar ket Ma nip ula ti

on , 112 H A RV
. L. R EV
. 1420, 1456 ( 1999)

. Upj ohn’ s a dv erti sementas ked the question , “Can an em erging bald spo t . . . d a m a ge your abilityto get along w ith oth ers, influ ence y our

ch ance of obtai nin g a job or date or

ev en i nter

fere w it h y our

j ob performa nce? ” Id. “ Anothe r ad featured an attract iv e female s tati ng uneq uiv ocal ly , ‘ I k now tha t a ma n w ho ca n af

ford Rogaine is a ma n w ho ca n af ford m e.’” Id. Com me nta tors have not ed th at since the first direct-to-co nsum er advertiseme nt in the 1 980s, “ ‘al most all phar maceut ic al compani es hav e eng ag ed i n thi s d irectmar ket ing practice .’” Id. (q uoti ng Bar bara J. Ty ler & R ober t A. C ooper , Bl

inded by the Hy pe: Shif ti ng the B ur den When Manufac tur

er s Engage in Di

re ct to C onsum er

Adv er ti si ng of Pr escri pti on Dr ugs , 21 V T
. L. R EV
. 1073, 1096 ( 1997) ). I n fact, “ from 1 9 9 5 t o 1 9 9 6 , dr ug co mpanie s increase d ad v ertising directed to consu me rs by nine ty perce nt.” Per ez , 734 A.2 d at 1251. By 1997, annual “ adv erti si ng cos ts of ph ar maceut ic al product s sur pass ed the h alf- bil li on dollar m ark for the first time , ‘easily out pacin g prom otion al ef forts directe d to ph y sicians.’” Id. ( q uoti ng Lars N oah, Adve rt ising Pr escription Dr

ugs to C onsum er

s: Ass essing

the Reg ula tor

y a nd Li

abi lity Iss ues , 32 G A
. L. R EV
. 1 4 1 , 1 4 1 ( 1 9 9 7 ) )

. A n d i n 2 0 01, phar maceut ic al compani es spent$2.38 bill ion on d irect -t o- cons umer mark eti ng
. Pal umbo & M ull ins , 57 F OOD & D RUG L.J. at 42 3.46

One n eed onl y

t u rn o n the tel ev is ion to see the e ffect s. See Bordes, 81 U. D ET
. M E R C Y L. R EV
. at 27 5. “A ny one w h o w atc hes tel ev is ion i s reg ula rl y bombarded w it h a
v ariety of p h a rm aceu tical produ cts w hich suggest thatthe ultim ate consu me r ask his physician to prescribe a particula r advertised produ ct.” Larkin v. Pfizer, Inc. , 153 S.W .3d 758, 771 (Ky . 200 4) ( W int ersc hei mer, J., dis sent ing ). It is no w onder that phar maceut ic al
com pan ies have expand ed the ir ad v ertising be cause , accordin g to est ima tes, co nsum ers now spend more than $1 trillion on hea lth-care prod ucts and serv ices per y ear, wi th roughly $70 bil li on bei ng spent on presc ri pti on dr ug s. C ohoon, 42 S. T EX
. L. R EV
. at 1353. And as
more adv erti si ng is direct ed at c onsumers, thos e ex pendi tures inc re ase. See Per ez , 734 A.2d at 12 52. Alon gside the increa se in direct m arketin g, the practice of med icine ha s dram atically chang ed. Al thoug h a doct or sti ll must w ri te a presc ri pti on for presc ri pti on dr ug s, “[ i] nformed
cons ent n ow

req uires a pat ien t- based dec is ion rather than the pat e rnali sti c a pproach of the 197 0s.” Id. at 12 55; see a lso Karl , 647 S.E.2d at 910. Ph y si ci ans no l ong er make the final dec is ion as to w hether a pa ti ent w il l tak e a dr ug —pat ien ts make thos e dec is ion s. See Teres a M oran Sc hw artz , Con sum er -D ir ected Pr

escri pti on D rug Adv

er ti si ng and the Lea rned Inte rm edia ry Rule , 46 F OOD D RUG C OSM
. L.J. 82 9, 83 1 ( 19 91 )

. M oreo v er , th e ti me doct ors s pend w it h the ir pati ents , and thus the ti me spe nt i n a s e rio u s dis cus si on of the ri sk s o f pharmac euti cal s, has chang ed—manag ed c are has reduc ed the ti me al lotted p er pati ent t o ten - or fifteen-mi nute appoi ntments , and now pati ents spend more ti me i n w ait ing
ro oms than they

do w it h the ir

doctor

. See Per

ez , 734 A.2 d at 1255. “ ‘I n a 1 997 s ur v ey of 1,0 00 p atien ts, the F.D.A. foun d tha t only one-third ha d received informa t io n f ro m th eir47

doct ors abo ut th e da ngerous side ef fects of drugs they w ere takin g.’” Id. (qu o t in g S h e ryl Gay Sto lbe rg , Faulty W

ar nin g Label

s Add to Ri

sk i n Pr escri pti on D rugs , N. Y. T I M ES , J une 4, 19 99, a t A2 7)

. T he im pacto f

a dvertising o n the p hysici an-p atien t relation ship ha s bee n dram atic. In 19 82, t he F DA

formal ly req uest ed a morat or ium on directadv erti si ng in order to all ow itto stu dy

the is sue. Pa lumbo & M ull ins , 57 F OOD & D RUG L.J. at 424. The F DA st udi es
re v eal ed th at c onsumers w ho v iewed adv erti si ng for presc ri pti on dr ug s ty pic all y “ re tai ned
mo re informa tion a bou t the b e n e f it s of the pro duct s than the risks.” Id. ( ci ti ng Loui s A

. Mo rr is & L loyd G. M il ls tei n, Dr ug Adv er ti si ng toC onsum er

s: Effe cts

of For m ats for Ma gaz ineand Televi

si on Adv er ti sem ents , 39 F OOD & D RUG L.J. 497 (19 84)). Th e FDA also found that “ cons umers w anted more in formati on about presc ri pti on dr ug s a nd woul d v iew direct-to-co nsum er advertising favorably .” Id. ( ci ti ng Loui s A. Mo rr is , Dav id Br inb erg & R on Kl imberg et al. , The Atti tudes of Con sum er

s Towar d Di re ct Adve rt

ising o f Prescri

pti on Dr ugs, 101 P UB
. H E A L TH R EP
. 82 ( 1986) ). After y ears o f patie nts bei ng su bje cte d to directadv erti si ng , physician s st ate thatthey are increasingly asked and pressured bytheir pati ents to presc ri be dr ug s t hat t he pat ien t has se en adv erti sed. F or ex ample, the die t dr ug co mbinat ion s k now n as fen-phe n w as presc ri bed despi te l ittl e hard s ci enti fic ev ide nce of i ts potent ial si de effect s. Physi ci ans are under

attack for presc ri bin g pill s too of

ten and too readi ly

to ina ppropr iat e pati ents

. Phy si ci ans arg ue i t i s n ot t hei r fault; ra ther , t hey cl aim pushy pati ents, prodded b y [di re ct- to- cons umer] adv erti sement s, press ed, w heedl ed, b eg g ed and berated them for q uic k t re atments

. . . . Physi ci ans claim th at it is impossib le to com pet e w ith ph a rm a c e utical com pan ies’ ma ssive advertising bud gets, and resig n the mse lv es to th e fact th at if cons umers make enoug h noi se, they w il l ev entuall y re len t t o pat ien t press ure. Tamar V. T erz ian , N ote, Di re ct- to- Con sum er

Pr escri pti on D rug Adv

er ti si ng, 25 A M
. J. L. &48

M ED
. 149 , 157 -58 (199 9). E. The Theoretica l Underpinnings of the Doctrine Do NotA pply When a Manufacturer Direc tly Markets to the Patient The chan g es in the d eli v er y of heal thc are broug ht ab out b y dire ctm a rketing and
m a n a ge d ca re d e m o n s t ra t e t h a tt h e t h e o re t ic a l u n d e rp in n in gs of the “learne d in t e rm e d ia ry” doct ri ne do not a ppl y

w hen a dr ug manufacture r d irect ly mar ket s t o i ts cons umers , t he pat ients. Fi rst, altho ugh a doct or mu st still w rite a prescription for prescription drugs, it i s cl ear thatmany

doctors a re not spend ing the amount o f time n e ce ss a ry t o pas s a lon g
w ar nin g s bypharmace uti cal companies

. See Per ez , 734 A.2 d at 12 55. The problem this
creates i s c ompounded by the fact that patie nts nowm ake the u lt imat e dec is ion s reg ardin g the d ru g s t hey

w il l tak e and often ask for dr ug s by name. Id. Secon d, drug ma nufactu rers wh o d ir e c t ly m a rk e tt h e ir p ro d u c t s t o co n s u m e rs a re h a rd -p re s s e d t o a rg u e t h a to n ly a physician w ould und erstan d the prope nsities an d da n ge rs i n vo lv ed a nd th at th ey lack effect iv e means to communi cat e di re ctl y w it h c onsumers. In fact, by direct ly mar ket ing to
c o n s u m e rs a n d p ro vid in g wa rn in gs in t h o s e a d ve rt is e m e n t s , d ru g m a n u fa c t u re rs h a ve compl etel y

undermi ned t hei r ow n arg uments

. See id. at 125 6. T hird, an d similarly , “it i s ill o gi c al tha t requiri ng man ufactu rers to provi de d irect w arnings to a con sum er w ill under mine the p ati ent- phy si ci an rela ti onshi p, w hen, by i ts v er y natu re , c onsumer-d irect ed adv erti si ng enc ro aches on t hat rela ti onshi p by enc ourag ing co nsumers t o as k for advertised pro duct s bynam e.” Id. ( q uoti ng Sus an A. C asey , C omment, L ayingan Old Doc tr ine to Res t: Cha llengi

ng th e Wisdomof the L ear ned Inter m edi ar y D oct ri ne , 19 W M
. M I T C H ELL L. R EV
. 931, 956 (1993) ( footnotes omi tted) ). I n s um, th e premis es under ly ing the doct ri ne are unpersuas iv e w hen cons ide re d in li g ht of di re ct mark eti ng to pati ents

. Id.As a cor ol l ar y , C ent ocor ar gues as par t of i t s f i r st i ssue t hat beca use Pat r i ci a’ s doct or s knew about 18 t he r i sk of

l upus- l i k e sy ndr om e, t he d oct or ’ s knowl edge negat es cau sat i on i n a war ni ng d ef ect cl ai m
. T hat i s tru e i n c a s e s w h e re th e d u tyto w a rn c a n b e s a ti s fie d b y a d e q u a te l y w a rn i n g a l e a rn e d i n te rm e d i a ry. See St ew art v. Janss en P har

m aceuti ca, I nc. , 78 0 S

. W

. 2d 91 0, 91 2 (T ex
. A pp
. –E l P as o 1 98 9, w ri t de ni ed ). H o w e v e r , w e h o ld t o d a y t h a t C e n to c o r c a n n o t r e ly o n its a d e q u a te w a r n in g s to P a tr ic ia ’s p h ys ic ia n s w h e n it d ir e c tlym i s re p re s e n te d i ts p ro d u c t’ s d a n g e ro u s p ro p e n s i ti e s to P a tri c i a
. In o th e r w o rd s , i t i s P a tri c ia ’s k nowl edge t hat i s r el ev ant , not her doct or s’ k nowl edge. L i k ewi se, wi t hi n i t s secon d i ssue, C ent ocorar gues t hat t her e was n o exp er t t est i m onyest abl i shi ng t hat a di ff er ent w ar ni ng woul d hav e cha nged Pat r i ci a’ s doct or s’ deci si on t o pr escr i be Rem i cade. Because we ha v e hel d t ha t C en t oc orcann ot r el y on i t s war ni ngs t o he r p h y s i c i a n s to s h i e l d i t fro m l i a b i l i tyi n th i s c a s e , w e o v e rr u l e th o s e i s s u e s
. 49 T he situ ation presen ted is more similar to the recogniz ed ex cept ions to the doctrine , w here
cour ts cons ide ri ng the is sue hav e found i t was unreason abl e for a manufacturer

to re ly on an i nter mediar

y to conv ey

a war nin g , g iv en th at di re ct a d vert isi ng and chang es in the prov is ion of heal thc are impactthe doct or ’s role and promote more acti v e i nv olv ement by the p ati ent. See s upr a Par t I I.C

. U nder

thes e c ircumsta n ce s, w e hol d tha t w hen a pha rmace utical com pan y directly marke ts to a pa tient , it must do so w ithou t f raud ulen tly misrep resen ting th e risks associated w ith its produ ct. Accordingly , w e overrule Centoco r’s firs t, sec ond, thi rd , and fourt h i ss ues to t he extent thos e i ss ues re ly o n the lea rn ed int er mediar

y doctr ine

. 18 III . E VI DENCE OF C A US A TI ON By i ts sec ond and fourt h i ss ues, C entoc or arg ues that the j udg ment s houl d be
re v ersed becau se Patr ic ia fail ed to presentl eg all y and factual ly

su ff ic ien t ev ide nce that (1 ) Remi cade caus ed th e i nju ri es she all eg edl y su f fe re d , and ( 2) di fferent war nin g s b y Cen toc or

woul d hav e prev ented thos e i nju ri es. A . St and ard o f Rev iew W hen cond ucting a legal suf f iciency rev iew , w e v iew the evidence in the light most favorable to th e v erdict to d ete rmine w het her the ev iden ce at trial w ould allow reason able50

and fair-mi nded pe opl e to re ach the v erdict und er rev iew

. Cit

y o f K e l le r v . Wils on, 168 S.W .3 d 80 2, 8 27 ( Tex

. 20 05 )

. W e "mu s t c red i t fav orab l e ev i de nc e i f rea s on ab l e j urors coul d, and dis re g ard cont ra ry ev ide nce unl ess reason abl e j urors c oul d not ." Id. W e w ill
sus tai n a c h a lle n ge to the l eg al suffici ency of ev ide nce onl y

i f: ( 1) there i s a co mplet e abse nce o f

ev iden ce of

a v ital fac t ; ( 2 ) th e cou rt is barred byrules of law or of ev iden ce f rom giv ing we ig h tto the only evidence o f fered to prove a v ital fact; (3) the ev iden ce offered to prov e a v it al fact i s n o more than a mere sc int il la; or (4 ) the e v ide nce est abl is hes
conc lus iv ely the oppos it e of a v it al fact. Id. at 81 0. More tha n a scintilla of ev iden ce exists, and t he ev ide nce is leg all y suff ic ien t, if the ev ide nce furni shes so me reason abl e bas is for differi ng co ncl usi ons by re asona ble minds abouta v it al fact's ex is tenc e. Lee Lew is Constr. Co. v. Har

ri son , 70 S.W .3d 7 78, 7 82- 83 ( Tex . 200 1)

. Howev er , "w hen t he ev ide nce offered to prov e a v it al fact i s s o w eak as to do no more than create a mere s ur mis e or su spi ci on of its ex is tenc e, t he ev ide nce is no more tha n a s ci nti ll a and, i n l eg al effect , i s n o
ev ide nce. " For

d Motor C o. v . Ridg way, 1 3 5 S. W .3 d 59 8 , 60 1 (T e x. 20 0 4 ) (ci ti n g Ki ndr ed
v. Con /Chem , Inc ., 65 0 S.W .2d 61, 63 (Tex. 1983 )). In c onducti ng a fact ual su ff ic ien cy rev iew , w e do not subs ti tute our judg ment for

that of t h e jur

y ; rather , w e v iew

al l the e v ide nce in a neut ra l li g ht t o det er mine w hether the evid en c e i s s o w ea ko r t he fi nd i ng i s s o c on trar y t o th e g rea t w ei g hta nd p rep on de rance of t he ev ide nce as to be manifest ly unj ust , shoc k t he c onsc ien ce, or cl ear ly demons trate bia s. See Cit

y o f Ke ller

, 168 S.W .3d a t 826 ; Golden Eagle Ar cher y, Inc . v . Jack son , 116 S.W .3d 7 57, 7 61 ( Tex . 200 3) ; Pool v. F or d Motor C o. , 715 S .W .2d 6 29, 6 35 (Te x . 198 6); Villago m ez

v. Ro ckwo od Spe cialties, In c. , 210 S.W .3d 7 20, 7 49 ( Tex . Ap p.–C or pus Chr is ti51

200 6, pe t. de nied ). B. Rem icad e as th e C ause o f Pat rici a’s S y mp to ms Cen toc or

co ntends thatthere w as no ev ide nce, di re ct or othe rw is e, t hat t he dr ug Remi cade caus ed Pat ri ci a’s i nju rie s. Spec ific all y , C entoc or arg ues that Patr ic ia did not presentany

ev ide nce of caus ati on by i ntroduci ng epi demiol og ic al stu die s s how ing that Remi cade inc re ased the r is ks of her al leg ed i njuri es. Ad dit ion all y , C entoc or arg ues that “[n]o comp ete nt w itness te stif ied th at ta king R em icade cause d Ham ilton’s alleged injuries; instea d, th e jury

w as lef t to m ake th at con clusion b ased on the t iming o f e v ent s” becau se the e v ide nce show ed onl y that (1 ) Patr ic ia took Remi cade, and (2 ) some t ime after tak ing Remi cade, sh e s uffered v ar iou s i nju ri es. Before w e add re ss t h e m er it s o f these arg uments , w e not e tha t C entoc or di d not
ra is e the se arg uments i n i ts moti ons for di re cte d v erdict, obj ect ion s t o the j ur y ch arg e, or
mo tions for judgme n t notw ithsta ndin g the v erdict. Rath er, Cento cor f irst raised these chal len g es to t he c a u sa ti o n e vi dence i n i ts moti on for new tr ial

. Thus, ev en i f w e ag re e wit h Ce n t o c o r t h a tt h e re is n o le ga ll y su f f ic ie n te vid e n c e o f c a u s a t io n o n t h is gro u n d , we mayonl y g ra nt C entoc or

a ne w tr ial

. See W

ern e r v
. Co lwe ll , 909 S.W .2d 8 66, 8 70 n. 1 (Tex . 199 5)

. Cen toc or

arg ues that Patr ic ia did not presentepi demiol og ic al st udi es to prov e tha t Remi cade can cau se l upus- li ke sy ndrome i n the g eneral popul ati on i n order to show g eneral caus ati on. See Me rr il l Dow Phar

m s., Inc . v

. Havner , 9 5 3 S

. W

. 2 d 7 0 6 , 7 1 4 (T e x. 1998) ( address ing us e of epi demiol og ic al stu die s as ev ide nce of caus ati on)

. It is tr ue th at Pat ricia did not pre sentepide mio logical stu d ies to prove general causa tion. Centoco r, howev er, doe s not ad dress on app eal ev iden ce showing general causation , som e of w hich52

C e n t o c o r i t s e l f p re s e n t e d a t tr ial

. Me dina v. Hart , 2 4 0 S

. W

. 3 d 1 6 , 2 2 -2 4 (T e x. App .–Corp us Christi 2007 , pet . den ied) (holdin g tha t w hile expert testim ony w as usu ally required to esta blish ne gli gence an d causa tion, testim ony adm itted bydefend ant , w hich defendant di d notaddress on a ppeal , c oul d s uppor t t he v erdict)

. For ex am ple, f irst, the pa ckage insert issued by Cento cor and app rov ed b y the FDA ack now led g es that lu pus- li ke sy ndrome is a ris k ass oci ated w it h taki ng Remic ade. The pack ag e i nser

t i tse lf des cr ibe d findi ng s from C entoc or ’s cl ini cal tr ial s p ri or to FD A approv al that found that some p ati ents may rar ely su ffer from l upus- li ke sy ndrome as a resul t of Remica d e
. C entoc or ’s w it ness , D r. M atthe w s, tes ti fied th at i f a ri sk as soc iat ed w it h a dr ug ’s treat ment is in cl uded on the pack ag e inser t, that ri sk

is “reason abl y

as soc iat ed” w it h the t re atment. S e c o n d , P a t ri c ia ’s d o c t o rs re p e a t e d ly t e s t if ie d t h a tt h e y knew of the r is ks of Remi cade treatment—spec ifica lly, the r is k o f lupus -l ik e s y ndrome. In fact , C entoc or
arg ued as much in i ts b rief: “ In t his ca se, the undi sput ed ev ide nce at t ri al prov ed th at Ham ilton’s do ctors knew ab outt he risks of Re mica de trea tm ent , particula rly of lupus-like sy ndro me .” B RI EF O F A P P E L L A NT at 14

. For ex ample, w hen as ked w hat D r. Bul len kn ew abo ut lup us, he answered, “W ell, I knew [Rem icade ] cause d a lupu s-like il lness. It’s v ery rare, bu t it cause d a lupu s-like problem , notlupus. ” Dr. Hauptm an te stif ied th at th e “rare si de effect of lu pus w as broug ht up w it h M rs . H amil ton,” and he ex pla ine d that he g ot t he not ion th at th e side ef fect w as rare f rom th e pa ckage inse rt a nd a lso f rom literat ure publ is hed by

doctors w ho w ere s ponso re d by C entoc or
. Mo re i mp o rt a n t l y , h o w ev er , C entoc or i tse lf put on ex pert t est imony that dem onst rated thatRemicad e cou ld cause lupus-like sy ndro me
. Ce nto cor re ad Dr. Trock’s53

depos it ion i nto t he record. Dr

. Troc k tes ti fied that in the g eneral popul ati on, “ about one out of ev ery 400 wom en o f

child-bea ring age ma y g et c o n c urrent lup us” along w ith the ir Crohn’ s dis ease. That conv er ts to a percen tag e of

0.25% of the popul ati on. Later i n the tes ti mony , D r. Troc k t est if ie d t hat i n recenttr ial s, the n umber of pati ents treated w it h Rem icade w ho d eveloped lupus-like sy ndro me w ent“up to two o r three per 100 ,” w hich converts t o a percen tage of 2% or 3%. Next, Cent ocor read the de positio n of Herbert Bonk ov sky ., M. D. H e tes ti fied th at l upus is a “ ra re but re cog nized c o m p lic ati on of the admini strati on of [R emic ade]

. . . .” Cen toc or it sel f put on thi s tes ti mony , and i t doe s n ot poi nt to any cont ra ry

ev ide nce in the record. See Havner , 953 S.W .2d at 717. C entoc or h a s n o te xp la in e d wh y t h is e vid e n c e co u ld n o th a ve su p p o rt e d t h e ju ry' s ve rd ic t , a n d we
now hol d tha t i t is both leg all y and factual ly

suff ic ien t to suppor

t t he v erdict. See Medi na , 240 S. W .3d a t 22- 24. Cen toc or n e xt arg ues that Patr ic ia did not put o n ev ide nce of spec ificca usat ion , proving thatR emic ade c aused her dr ug -i nduce d l upus- li ke sy ndrome. It conc edes that “[ e]v ide nce of an ev ent fol lowed cl osel y by mani festati on of or

treatment for c ondi ti ons
w hic h di d notappear before the ev ent rai ses suspi ci on that t he ev ent a t i ss ue c aused the
c o n d it io n s.” Guev

ar a v . F er re r , 247 S.W .3d 662 , 668 (Tex. 2007 ). C ent ocor argues, how ev er , t hat “ sus pic ion has not been and i s n ot l eg all y su ff ic ien t t o s uppor

t a findi ng of legal causa tion. ” Id. Cento cor a rg ues tha t besid es sequen ce-of-ev ent s ev iden ce, Pa tricia did not presentany

ev ide nce that Remi cade caus ed her i nju ri es; thus , Pa tr ic ia did not prov e s p e ci fic c ausat ion

. To re ach thi s c oncl usi on, a g ain , C entoc or i g nores most of the
ev ide nce in the record, i ncl udi ng ev ide nce from i ts ow n ex per ts. Fi rs t, Dr . Er

tan was an ex per

t w it ness for C entoc or
. He tes ti fied th at he w as the54

principa l inv estigator for Cento cor w hen it tested Rem icade ’s ef f icacy in treatin g Crohn’s d ise a se an d th a t he a gre e d w it h Pa tr ici a ’s d o ct o rs in Ho u st o n th a t P a tr ici a de velo p e d dru gind uced lup us- li ke sy ndro me
. S econd , C entoc or ’s othe r ex per t w it ness , D r. Ol sen, tes ti fied that she d ia g nosed Pat ri ci a w it h dr ug -i nduce d l upus- li ke sy ndrome ca used by her Re m ica d e tre a tm e n t. Fin a lly, Dr . T ro ckt e s ti f ie d th a t h e di a gno se d Pa tr ici a w it h dru gind uced lu pus- li ke sy ndrome caused by her Remi cade treatment. C entoc or does not poi nt t o a n y co n t ra ry e vid e n c e in t h e re c o rd

. Ce n t o c o r d o e s n o td is c u s s t h is e vid e n c e , wh ic h we hol d i s l eg all y

and factual ly

su ff ic ien t t o s uppor

t t he v erdict. See Medi na , 240 S.W .3d a t 22- 24. C. In adeq uat e Warn in g as a Cau se o f Pat rici a’s I nj ur ies Fi nal ly , C entoc o r a rg ues that there i s n o ev ide nce that a di fferent war nin g by Cen toc or

woul d h a ve p re v ented Patr ic ia’ s i nju ri es and t hat t he al leg edl y fraudul ent sta tements i n the v ide o di d notca use Patr ic ia to t ake Remi cade becau se she w atc hed t he
v ide o after

D r. H auptman p re sc ribed Re mic ade w hil e s he w as re cei v ing a R emic ade infusi on. Cen toc or

furth er arg ues that there i s n o ev ide nce that Patr ic ia w oul d hav e acted di fferen tl y

h ad a d i fferen t w ar ni ng b ee n prov i ded beca use e v en a fte r P at r i c i a be c am e
aw are of the ri sk

of lup us- li ke sy ndrome, w hic h i t argu e s o cc ur re d w hen D r. Pop- Mo ody dis cus sed lup us w it h her i n the sp ri ng of 2003, Patricia c o nti nued t o recei v e R emic ade inf usion s. How ever, once again, Cento cor d oes nota ddre ss a ll the evidence in th e record that coul d hav e s uppor ted t he j ur

y ’s v erdict. Patr ic ia deni ed th at D r. Pop- Mo ody tol d her thatR em ica d e c o uld be causing her lup us- li ke sy ndrome, and D r. Pop- Mo ody ’s note s i ndi cat e tha t s he to ld her on ly th at

“ [p ]o s i ti v e s erol og y

for l up us i s n otu nu s ua l w i th t he R em i c ad e bu t de v el op i ng s y mp to ms55

of lupus w oul d i ndi cat e tha t t he pati ent has the condi ti on and then the R emic ade i nfusion s
w on'tbe s o hel pful.” Thus, it is not cl ear , as Cen toc or seems to arg ue, that in the s pr ing of 200 3, Pa tricia w as aware that ad dition al inf usion s might w orsen her proble ms. To the c ontrar

y , D r. Pop- Mo ody ’s note s an d Pat ri ci a’s tes ti mony i ndi cat ed th at at that ti me, she did not w ant to stop treatment w it h R emic ade bec ause she bel iev ed i t w as the only thing gi v ing her relief f rom h er sy mp tom s. And th e evidence showed that , albe it for a short amount o f time a fter e ach infusi on, P atr ic ia did hav e s ome reli ef f ro m her sy mptoms. Pa tr ic ia tes ti fied that af ter w atc hin g the Cen toc or

v ide o, s he di d notbel iev e s he had t o do any

furth er research or

as k a ny m ore ques ti ons, and she als o tes ti fied th at ha d she b een w arne d of lupu s-like sy ndro me , she would have asked mo re question s. It is also
re a s o n a b le t o a s s u m e t h a t , h a d P a t ri c ia b e e n a d e qu a t e ly war n e d , s h e wo u l d n o th a ve been un der

the impress ion thatR emic ade w as the i nst ru ment of her reli ef f ro m her

jo int pai n. Cen toc or

does not address thi s t est imony or ex pla in why itd id not s uppor t t he
v erdict. Furthe rmore , the fact that Patricia w atch ed the v ideo af ter Dr. Haup t m a n f irst presc rib e d R emic ade doe s n ot ne ces sar il y under mine a findi ng of caus ati on. The
ev ide nce at t ri al showed th at D r. H auptman presc ri bed a n i nduct ion se ri es of three infus io n s o f

R emic ade ov er

a s ix-week per iod

. Patr ic ia deni ed th at D r. H auptman discusse d lupu s-like sy ndro me w ith her at the t ime h e prescribed t he Rem icade

. Patricia
saw the v ide o dur ing her

first in fusion presc ri bed byD r. H auptman. Sh e tes ti fied th at after
w atch ing the v ideo , she " feltv eryg ood abo ut Rem icade treatm ent .” She explained , “I thoug ht i t w as g oin g to chang e my l ife and make me fe e l great l ik e al l the p eopl e i n the
v ide o."56

The facts of this ca se show that at the ti me Dr

. Hau ptman presc ri bed t he R emic ade, Patr ic ia bel iev ed s he woul d o n ly n eed t hree i nfusion s. H ow ev er , after thos e first three infusi ons she beg an ex per ien ci ng se v ere j oin t pai n, an d s he v is it ed D r. Pop- Mo ody , w ho adv is ed th at P atr ic ia cont inu e the R emic ade i nfusion s i ndefini tel y . T hus, Pat ri ci a w as again required to make a decision as to w het her to take Rem icade inf usion s after w atc hin g the v ide o. S h e t e st if ied thatsh e di d nothav e any co ncer ns about tak ing addi ti onal infusi ons after w atc hin g the v ide o, w hic h c onv inc ed her thatsh e did n o t n e e d t o do any addi ti onal research. O nce ag ain , C entoc or does notaddress w hy

thi s e v ide nce does not suppo rtthe jud g ment, and w e bel iev e thi s e v ide nce w as leg all y and factual ly

su ff ic ien t t o demonst ra te c ausat ion

. See Medi na , 240 S. W .3d a t 22- 24; see, e. g., Merck & Co., In c.
v. Gar za, 277 S.W .3d 4 30, 438 (Tex . App.–San Anton io 2008, pet. g ra nted) ( hol din g that
w here a doct or

co nti nued presc ri pti on of dr ug presc ri bed by pr ior doctor , and enl arg ed t im e p e ri o d o f

p re s c ri p t io n , t h e re le va n tis s u e wa s wh e t h e r a d e qu a t e wa rn in g wo u ld h a ve prevente d seco nd p rescription). In s um, w e ov er ru le Ce ntoc or ’s second and four th is sues bec ause w e hol d tha t t he
ev ide nce, mostof w hic h C entoc or co mplet ely

i g nores, i s l eg all y

and factual ly

su ff ic ien t t o suppo rtthe findi ng of caus ati on. See Medi na , 240 S.W .3d a t 22- 24. IV. A D EQU A C Y OF TH E WA RNI NG By it s thi rd is sue, Cen toc or arg ues that it s war nin g w as adeq uate. F irst, C entoc or
ass erts th a t Pa tr ic ia faile d to presentl eg all y and factual ly

su ff ic ien t ev ide nce that the
w arnings w ere inad equate beca use n o expert testif ied th at th e Rem icade w arnings w ere inad equate

. Seco nd, Cento cor argues thatthe risk of lupus-like sy ndro me did notmake57

Remi cade unreason abl y dang erous. W e di sag re e. A . Expe rt Testimony Fi rs t, Cen toc or

arg ues that it“ unq uest ion ably ” prov ide d w ar nin g s t o Pat ri ci a, inc lud ing a pa ck ag e i nser t and a v ide otape, and that Pa tr ic ia w as re q uired to prov e tha t thes e w ar nin g s were i nadeq uate. Centoc or , how ev er , ig nores si g nific ant t est imony from it s o w n ex per

t w it ness , D r. M atthe w s, that sat is fied th is req uirement. Testi mony

from Dr. Ma tthews, Cen toc or ’s ex per t, confir ms t hat t he c omplet e
a b s e n c e o f

a w a r n i n g i n t h e v i d e o re g a rd i n g l u p u s - l i k e s y n d ro m e fa i l e d t o s a t i s fy Cen toc or ’s duty

to w ar n a pati ent direct ly of k now n si de effect s. Dr . M atthe w s t est ified at len g th ab o u t what i nformati on mus t be inc lud ed i n adv erti sement s b y phar maceut ic al
com pan ies. Patricia introd uced a copy of chap ter 21 o f

the Cod e of

Federa l Reg ulatio ns,
secti on 202. 1, w hic h gov er ns adv erti sement s bydrug companies

. See21 C .F .R . § 202.1 (2 002)

. Dr

. Ma tthews ex pla ine d that thi s re g ula ti on w oul d appl y to t he v ide o produce d by Cen toc or

and show n to Patr ic ia at t he i nfusion cl ini c. Dr . M atthe w s tes ti fied th at ad v erti sement s for dr ug s, inc lud ing the Cen toc or v ide o,
are req uired to i ncl ude “ fair bal ance” infor mati on, a nd s he referred to 21 C .F .R . s ect ion 202 .1(e)(3)(i) and (ii i), w hich provides: (3) Scop e of info rm ation to be inclu ded ; app licability to th e en tire adver ti sem ent. (i ) The req uirement of a t ru e s tatement of informat ion rela ti ng to side ef

fects, co ntrain dicatio ns, an d ef fe c t ive n e ss app lies to the entire adv erti sement

. Unt ru e or mis le a d in g informati on i n any par t of the advertisem entw ill notbe correcte d by the in c lu s ion in an oth er distinct pa rt of the adv erti sementa br ief s tatementco ntai nin g tr ue informati on rela ti ng to si de effects, co ntrain dic ati ons, and effect iv eness of the dr ug
. If any

part or theme of the adv erti sementw oul d make the adv erti sementfals e or mis lea din g by

reason of the omis si on of ap propr iat e q ual ific ati on or per ti nent infor mati on, t hat p art or theme shal l inc lud e the appropr iat e q ual ific ati on or p e rt in e n tin fo r m a t io n , wh ic h m a y b e co n c is e if itis su p p le m e n t e d b y a58

prom inen t referen ce on each page to the prese nce a nd loca tion e lsew here in the a dv erti sementof a more compl ete dis cus si on of s uch q ual ific ati on or infor mati on.

. . . . (iii ) The info rm ation relating to side effe cts and contrain dic ation s shall dis close each specif

ic si de ef fec t and co ntr ain dicati ons (which include side effe cts, w

arning s, preca ution s, and contrain dicatio ns an d include an y such information under such head ings as caut

ions, spe c ia l co nside ration s, im por tant not e s, e tc; s ee par agr aph ( e) (1) of t his se cti on) co ntai

ned i n the re qui re d, appr

oved, or per m itted l abel ing for the adver

tised dr ug dos age for m (s );

. . . . Id. § 20 2.1( e) (3 )( i) , ( ii i) ( emphasi s a dded)

. Dr . M atthe w s s tated that an adv erti sement must inc lud e tr ue i nformati on reg ardin g “s ide ef fects, w ar nin g s, precaut ion s, cont ra ind ic ati ons, and inc lud es any su ch infor mati on under su ch headi ng s a s c auti ons, sp e cial co nsi derati ons, i mport ant n otes , and so forth , and effecti v eness .” Dr . M atthe w s t hen admi tted that an adv erti sementi s n ot a tr ue sta tement if “ iti s fal se or mis lea din g w it h respect t o s ide e f fe cts , c ontrain dic ati ons, or effect iv eness .” Sh e agreed that an adv erti sementis als o mi sl eadi ng i f it “fai ls to present
a fai r bal ance betwee n i n for mati on rela ti ng to si de effects and c ontrain dic ati ons and in fo rm a t io n re la t e d t o e f fe c t i v e n e s s o f

t h e d ru g. ” (E m p h a s is a d d e d ). Dr

. Ma t t h e ws tes ti fied, h ow ev er , t hat a n adv erti sementi s n ot mi sl eadin g if the “ present ati on of tr ue informa tion relat ing to side ef fects an d con traind ication s is compa rable in de pth and deta il
w ith the claims for ef

fectiveness an d safety.” Mo st impor

tantl y , w it h respect t o s ide effect s, Dr. Ma tt hews e x pla ine d tha t adv erti sement s must inc lud e infor mati on that is “c onsi ste nt w it h w hat’ s i n the l abel ing , t he pack ag e i nser

t.” Dr . M atthe w s a g re ed th at t he i ntentof the re g ula ti ons of dr ug adv erti si ng59

was n o t t o requ ire p a ti e n ts to re a d p a ck a ge ins e rt s, whic h sh e refe rre d to as th e “la b e lin g” ins tead of adv erti si ng
. H ow ev er , s he c lar ified thatthe pack ag e i nser t i nter re lat es w it h dr ug advertising because “it has to be w hat ’s in the labe l.” Dr . Matt hews then test ified that she beli ev ed that t he v ide o w as not mi sl eadi ng , and inc lud ed “ fair

bal ance” i nformati on, b ecaus e the “ theme” of the vid eo w as the i nfusion proce ss. She disa greed thatthe video sho w ed m ore informa tion a bou t Remic ade ’s effect iv eness than w ar nin g s a bout the d ru g
. Dr . Mat th e w s a g re ed th at t here w as no
w ar nin g aboutl u p u s-l ike s y ndrome, butsh e c lai med thatthe v ide o w as fair ly bal anced beca use it “said t o also ask y our physician and t hen t o referen ce the p ackage inse rt, w hich I w as under

the impress ion w hen you s aw the v ide o y ou w ere gi v en a li ttl e c ard and then als o the pac kag e i nser t.” It w as un dispu ted thatthe video itself did notprovi d e a wa rn ing abou t lupu s-like sy ndrome. And P atr ic ia tes ti fied th at t he pac kag e inser t w as not i ncl uded w it h the v ide o sh e w a tc h e d

. T h e b o x co n ta in in g t h e vid e o d id n o t h a ve a p la st ic sle e ve to h o ld a pa ck a ge inse rt , as did a late r v ideo produ ced b y Cento cor. Cento cor doe s not ad dress this evidence, w hich allowed the jury to conclu de th at Pat ricia rece iv ed no w arning abo ut lup usli ke sy ndrome from t he v ide o i t dire ct ly mar ket ed to her

or from any

ac company ing document ati on. In t his ca se, w e hol d t h a t Dr. Ma tthews’ s t est imony , puton b y C entoc or , s ati sfied the req uirement of ex per t t est imony

on h ow to jud g e the adeq uacy of t he w ar nin g , and the only i ssue left for the jury to de cide w as w het her the facts w ere as Cen toco r’s ex pert
ass u m e d t hem to be. For ex ample, i n Medina v. Hart , a me dical ma lpractice case , Hart
su e d hi s d o ct o r, Dr. Med in a , a f te r he rec e ived se co n d an d th ird -d e g r e e b u rn s d u rin g a60

surg er y to re mov e a k idn ey

st one. 240 S.W .3d a t 18- 19. Dr . M edi na had pla ced an IVbag fill ed w it h flui d under Har t’ s ri g ht ar m to posi ti on and cus hio n Har t dur ing the surg er

y . Id. at 18

. W hen H art awoke from su rg er y , he had bur ns under

hi s r ig ht ar m w here the IV bag had bee n pl aced. Id. at 19. Dr . M edi na te sti fied attr ial

. She a d m it ted t hat i t w as her duty to ensure tha t her pati ent woul d notbe i nju re d dur ing su rg er y , w hic h incl uded the duty to proper ly

pos it ion the pati ent for

su rg er y . Id. at 20. She ad m it te d t h a t it w oul d be a breach of the s tandard of
care to pla ce a hot IV b ag under a pa ti ent’ s a rm dur ing su rg er y . Id. Sh e al so admitted t hat
som eho w

the IVbag she p la c e d un der Hart’s arm be cam e he ate d an d cau sed Hart’s bur ns. Id. The mai n dis pute at tr ial , therefore, w as ov er how the bag became heated. Id. at2 1. Dr

. M ed i na t es ti fi ed t ha t th e ba g w as n oth otw he n s he p l ac ed i t un de r H ar t’ s a r m, but H art’ s w ife tes ti fied th at a nurse tol d her that the bag had been he ated and w ra pped in a towel pr ior

to bei ng pl aced under

H art’ s a rm. Id. Hart’s w ife test if ied th at a nurse told he r a bo uta c on v ers at i on s he had with Dr. M ed i na d ur i ng w hi c h D r
. M ed i na b ec am e ag it ated after the nurse q uest ion ed w hether the bag had been heated. Id. Dr . Medina ’s assistan t the n stat ed, “I w ish som e pe ople w ould just simply tell the truth.” Id. On a p p e a l , D r
. M e d i n a a rg u e d t h a t t h e re w a s n o e x p e rt t e s t i mo n y o n s t a n d a rd of
care, breach, and caus ati on. Id. at 22. W e hel d tha t D r. Me d in a h ad j udi ci all y admi tted negligence an d cau sation bystating t hatplacing a hea ted bag unde r a patien t’s arm w ould be neg li g ent a nd c oul d c ause a bur n l ik e H art’ s. Id. a t 24. W e f urthe r held tha t the only is sue in dis pute w as one of fact w hic h w as for th e j ur y to deci de—ho w

and w hen t he bag became hot. Id.61

In t his ca se, D r. M atthe w s, Cen toc or ’s ex per t, tes ti fied th at a w ar nin g i n an adv erti sementmusti ncl ude the informati on in the packag e inser t. She tes ti fied th at s he bel iev ed th at t he w ar nin g s i n the v ide o w ere adeq uate becau se she ass umed tha t a pati ent
w atc hin g the Cen toc or

v ide o w oul d als o re cei v e the pack ag e ins ert, w hic h woul d prov ide the comp lete warning. In con trast to th is, the jury also he ard test imo ny f rom Pa tricia
s t a t i n g t h a tt h e p a c k a g e i n s e rtw a s n o ti n c l u d e d a l o n g w i t h t h e vi deo. See B ur ro ughs W ellcom e Co. v. Crye , 907 S.W .2d 4 97, 4 99- 500 ( Tex . 1995) ( hol din g ex per t’ s c oncl usi on could b e disregarded when base d on assum ed facts notsupp orted bytestim ony at trial). T he jur y w as en ti tl ed to rel y on D r
. M atth ews ’ s op i ni on th at an ad eq ua te w ar ni ng must inc lud e the i nformati on i n the pac kag e i nser t, and res olv e the fact i ss ue of w hether or not th e vid e o incl uded s uch infor mati on. It re sol v ed th at i ss ue i n Pat ri ci a’s fav or
. Id. W e
ov er ru le Cen toc or ’s i ss ue i n thi s reg ard. B. Un av oi dab ly

U nsaf e Prod uct Next, Centocor

arg ues that Patr ic ia faile d to prov e tha t t he w ar nin g s made Remi cade defecti v e by render ing i t unreason abl y dang erous. C entoc or arg ues that the undi sput ed ev ide nce showed th at dr ug -i nduce d l upus- li ke sy ndrome w as not da ng erous becau se the s y mptoms are not“ sev ere,” i n the sens e that Patr ic ia re q uired hos pit ali z ati on, and bec ause dis cont inu ing the Remi cade treatment eli minat ed the sy mptoms. In addi ti on, Cen toc or

arg ues that Re m ic ade “ w or ked” by putt ing Pat ri ci a’s C ro hn’ s d is ease int o
re mis si on and temporar il y g av e Pat ri ci a reli ef f ro m her ar thr it is

. Cen toc or

ac know led g es that Patr ic ia suffered pai n betw een infusi ons, but it urg es the Cou rt to hol d “ as a matt er of l a w ” th a tte mp o ra r

y p a i n i s n o tt h e ty p e o f danger thatmakes a presc ri pti on dr ug defecti v e,C ent ocorar gues i n one sent ence i n t hi s i ssue t hat t he j ur y di d no t hav e t he o ppor t uni t y t o de t er m i ne 19 i fR em i cade was def ect i v e be cause t he t r i al cour t r ef used C ent ocor ’ s pr oposed “ m ar k et i ng d ef ect ” i nst r uct i on wi t h r espect t o Cent ocor ’ s neg l i gence cl ai m
. Cent ocor , howev er , doe s notbr i eft hi s as an i ssue a nd d i d no t a s k f o r th is in s tr u c tio n w ith r e s p e c t t o th e f r a u d c la im , w h ic h is th e c a u s e o f a c tio n o n w h ic h th e ju d g m e n t is b a s e d

. See T EX
. R. A PP
. P. 38

. 1(i ). 62 citing section 40 2A of

the Resta tem entof

To rts (Second ). 19 Fi rs t, w e not e tha t ag ain , C entoc or i g nores m u ch of the record to make i ts conclu sions. Pa tricia’s sy mp tom s, w hile tem pora ry , w ere certainly sev ere. Pat ricia could not d re ss hersel f becaus e her sh oul ders were s o pai nful. She al so tes ti fied th at s he w as afrai d to dr iv e her

ca r becau se she w as afrai d tha t her p a in w oul d prev ent h er from ope rating it safely. Patricia’s husba nd, Th om as, testif ied that she could no longer perform her dai ly functi ons, i ncl udi ng ca ri ng for h er co los tomy

. This pai n, w hil e temporar il y reli ev ed by the Remi cade infusi ons, persi ste d from Ma rc h of 20 01 unti l Oct ober of 2003, w hen s he
w as w eaned o ff

R emic ade. And Cen toc or ’s arg ument t hat P a tr ici a nev er had to be hospi tal iz ed i s n ot s uppor ted b y the re cord—Pa tr ic ia w as hospi tal iz ed w hen s he s uffered from per ic ardit is , w hic h w as a s y mptom of her l upus- li ke sy ndrome. Nev erthel ess , as sumi ng w it hout deci din g that Patr ic ia had to prov e tha t R emic ade
w as unreason abl y

dang e ro u s to recov er

on h er fraud cl aim, C entoc or

does not ci te an y cas e l aw i n s uppor

t of i ts arg ument t hat a dr ug mustca use a per manent si de ef fect in order to be u n re asona bly

dang erous as mark eted, and w e refuse to hol d as much. C entoc or
arg ues that some p ro duct s “ canno t pos si bly be made entirely

safe for all co nsumpt ion , and any food or drug necess ar il y

inv olv es some ri sk

of har m, i f only

from ov er-c onsumpt ion .” R E S TA TE ME NT (S E COND ) OF T OR T S § 402 A cmt

. i (19 65). Cento cor f urthe r arg ues th at th ere
are s ome products w hic h are “q uit e incap abl e of being m ade safe for their intended and
ord i n a r y u s e
. . . . S u c h a p ro d u c t , p ro p e r l y p re p a re d , a n d a c c o mp a n i e d b y properW i t hi n i t s fou rt h i s s ue , C en t oc or al s o m ak es s eve ral arg um en t s reg ard i ng t he l ea rne d i nterm ed i ary 20 doct r i ne a nd ca usat i on, whi ch we h av e al r eadyadd r essed. 63 direction s and w arning, is not de fective, nor is it unre ason ably dangerous. ” Id. cmt . k

. Cen toc or

reli es on th is l ang uag e to arg ue th at i t has no l iab il ity bec ause Remi cade could not po ssibly

be m ade entirely safe. T he a rg um entt h e n p ro gr e sses to Cen toco r’s
co n clu sio n th a t itm a y sel l a pro d u ctth a t is da n gero u s e ven w it h o u t a n ad e qua te w a rn in g, merel y bec ause the dang erous cons eq uence s a re onl y temporar

y . But Cen toc or

i g nores th e R e s t a t e me n t ’ s s o l u t i o n t o a n u n a v o i d a b l y u n s a fe p ro d u c t

— p ro v i d e a n a d e q uate
w ar nin g
. Id. ( “The sel ler of suc h product s, aga in with the qu alif ic a t io n that they are pr oper ly prepar ed and m ar

keted, and proper

war nin g is giv

en, wher e thesituati

on c all s f or it , is not to be hel d to str ict l iab il ity for u n fo rt u n a te cons eq uence s a ttend ing thei r use, merel y bec ause he has under tak en to su ppl y

the publ ic with an app arentl y us eful and desi ra ble product , attended w it h a k now n butapparentl y reason abl e r is k.” ). C omment k to sect ion 402A mayprov ide a defense to a de si g n defect cl aim, but itce rt ain ly does not absol v e a man ufacturer of it s l iab il ity

for c omplet ely

fail ing to w ar n of a dang erous si de eff ect

. See Car la P. H er ro n & Kel li L. Deg eeter , C an T exas E s c ap e th e U

na v oi da bly Uns afe Medici

ne of Com m ent k by Adopti ng Secti on 8 of the Propos ed Thi rd R est atem ent of Torts? , 49 B A Y L OR L. R EV
. 73, 78 (199 7) (“Thu s, once co m m e n tki s a pplied , all q uest ion s o f a product 's desi g n become ir re lev ant and the focus sh ifts to t he adeq uacy , or
reaso nab lene ss, of the w arning of the prod uct's r isks.”). Accordin gly , we o ve rrule Cen toc or ’s thi rd i ss ue. V. Ev idence of Fraudulent Intent 20 W it hin i ts fourth is su e , Ce n toc or arg ues that there i s n o ev ide nce that iti ntended64

that Patr ic ia re ly

on a mater ial omis si on. Spec ific all y , there is no ev ide nce that Cen toc or int ended for

Pat ri ci a to tak e R emic ade w it hout adeq uate know led g e of t he poss ibl e s ide ef fects. It asse rts tha t the v ideo directed patie nts to conta ct the ir phy sicians ab outpossible si de effects and c ontai ned t he pac kag e i nser t t hat d is cl osed all of the a ss o ci ated si de effect s. C entoc or

furth er arg ues that, becau se the jur y ’s findi ng of puni ti v e damag es w as p re d i c a t e d o n t h e f r a u d f i n d i n g , t h e p u n i t i v e d a m a g e s a w a rd m u s tb e re v e rs e d

. W e dis ag re e. A misl e a d i n g p a rt i a l d i s c l o s u re o f i n fo r ma t i o n i s a c t i o n a b l e i f i ti s m a d e w i t h t he int ent t o i nduce acti on by anot her

. Se ar

s, R oe bu ck

&C o. v . Mea do ws , 877 S.W .2d 2 81, 282 ( Tex . 199 4) ; see Colu m bia/HCA Hea lthcare Corp

. v. Cottey, 7 2 S

. W

. 3 d 7 3 5 , 7 4 5 (T e x. App.–W aco 2002, no pet .) ( “The p ro p er q uest ion as to the e lementof ‘i ntent ’ is w hether Cottey prov ed that, at the ti me he acc epted employ ment, Appel lan ts int ended for C ottey to act or rely on t h e ir p arti al dis cl osure aboutthe pla n w hic h omi tted menti on of the rescission provision.”). “ Inte nt is a fact question u niquely w ithin the rea lm of t he trier o f

fact becau se itso depends upon the credi bil ity of the w it ness es and t he w eig ht t o be g iv en to the ir testimo ny.” Spo ljaric v. Percival Tours, In c. , 708 S.W .2d 4 32, 4 34 ( Tex . 198 6)

. Inten t maybe i nferred from a par ty ’s acti ons before and after the fraudul ent conduct and m ay be prov en by

the ci rc umstan ces su rroundi ng the fraud. Id. Here, t he v ide o s peaks for i tse lf. Al thoug h the vid e o does adv is e the pati ent t hat a doctor sh oul d ex pla in Remi cade’ s s ide effect s, the v ide o i mpli es that all the si de effects associa ted w ith the drug are addresse d in the v ideo beca use some of the side ef fects are act ual ly address ed. This i s p arti cul ar ly so b e ca u se in the s ame di sc uss ion i n w hic h he advises v iew ers t o consu lt t heir doct ors, Dr. Sa fdi state s that“the v ast m ajority of patie nts,65

in our ex per ien ce, hav e no probl ems w it h the i nfusion .” H e furt her st ates that“ [a]fter

the infusi on th ere are v er

y l ittl e s ide effect s t hat p eop le n e e d t o w atc h for. I f they hav e any dis comfort , w e as k t hem to g iv e us a cal l. But th ose re act ion s, ag ain , are extremely rare. And t he v astmaj or ity

of pati ents real ly

ex per ien ce n o s ide effect s.” Thi s i mpli ed th at “discom fort” w as the only side ef fect t o wa t ch for af

ter the inf usion process, which is demonst ra bly

fals e gi v en that the packag e inser t w ar ns of sev eral other side effect s t hat mayoc cur

after the infusi on. Dr . Bu l l e n t e s t i fi e d t h a tt h e p u r p o s e o f t h e v i d e o w a s t o s h o w t h e d r u g ’ s e ffe c ton peopl e, w hic h w as dramati c. In fact, the main thr ustof the v ide o w as to s how how w ell the p a ti e n ts fe lto n R e m ica d e
. T h ro u gho u t th e f ilm , th e p a ti e n ts are sh o wn walk in g, ru n n in g,
car ry ing thei r chi ldren, a nd ex cl aimi ng howg re at t hey feel. F ina ll y , t he ev ide nce showed that the p ack ag e i nser

t w as not i ncl uded w it h the v ide o show n and g iv en to Patri ci a. The state me nts regarding the ef f icacy of the drug is not bala nced w ith any disclosure of the risk of lupus -l ik e s y ndrome, or the othe r ris ks assoc iat ed w it h the dr ug bes ide s i mmediat e reactio ns to th e inf usion process. The e vide nce of Cent ocor ’s mar ket ing st ra teg ies sh ow s t hat t his emphas is of the dr ug ’s eff ic acy

and the o mis si on of r is k i nformati on w as int ended t o i ndu ce d o ctors to presc ri be R emic ade and to ind uce pati ents to seek treat ment w it h R emic ade. As of June 2000, Ce n tocor’ s mar ket ing st ra teg y i ncl uded a tw o- prong ed approach that inc lud ed edu cating physicians to “ref ine the ir de f inition of t he target Rem icade patie nt” and to tea ch pati ents to “d emand Remic ade.” Fi rs t, Cent ocor sales represent ati v es w ere i nst ru cte d to
w or k o n maki ng doctors “ ag g re ss iv e” in pres cr ibi ng Remic ade, and C entoc or req uired i ts sales asso ciates to sell a specif ic num ber of v ials of Remicad e to do ctors’ of f ices.T he Ham i l t ons a r gue t hat an e- m ai l f r om C ent ocor ’ s di r ect orofI m m unol ogyM ar k et i ng shows t hat 21 C ent ocor ’ s sal es f or ce “ begge d” t o r em ov e “ f ai r bal ance” i nf or m at i on f r om t he “ pat i ent success st or y ” v i deos b e c a u s e “ p a tie n ts w e r e g e tt in g f r ig h te n e d .” H o w e v e r , th is e - m a il w a s n e v e r a d m itt e d in to e v id e n c e a t t r ia l; r a th e r , it a p p e a r s in th e r e c o r d a s a n a tt a c h m e n t to t h e H a m ilto n s ’ r e s p o n s e t o C e n to c o r ’s m o tio n f o r n e w tr ia l. A s d a m a g i n g a s th i s e -m a i l i s , w e c a n n o t c o n s i d e r i t b e c a u s e i t w a s n o t m a d e p a rt o f th e re c o rd a t t ria l

. See M axim um Med. I m pr

ovem ent, I nc. v. C ount y of D al las , 272 S. W

. 3d 8 32, 834 n. 3 ( T ex. App. –D al l as 20 08, no pe t

. ). 66 Cen toc or

represent ati v es ev en promoted t he i dea t hat doct ors c oul d max imi z e the ir profits from presc ribing R emic ade by prov idi ng i n- off ic e i nfusion s t hat woul d be pai d for by Me dic are and Me dic aid

. Seco nd, Ce nto cor’s goal w as to m ake Rem icade “top of mind ” fo r ev eryrheum ato id
arthr it is pati ent. A c har t admi tted int o e vide n ce shows C entoc or ’s pl an for address ing pati ents , and i t s tates thatthe g oal i s t o “ [m]ak e the consumer aw are the [medi cal ] probl em is treatabl e” and to “ [e]nc ourag e the pati ent t o req uesta s pecif ic d ru g.” O bv iou sl y , t he Ce n t o c o r vi d e o wa s p a rto f t h is m a rk e t in g s t ra t e gy. 21 F u rt h e rm o re , t h e re wa s si gn if ic a n tt e s t im o n y a b o u tCe n t o c o r’ s a t t e m p t s t o m in im ize neg a ti ve publ ic ity

about the dang erous si de effects of Remi cade. A sc ien ti fic s tudy publ is hed i n the N ew

Eng lan d J our nal of Me dic ine demons trated that probl em s w it h Remi cade had been unders tated

. Ins tead of addres si ng the subs tanti v e s afetyco ncer ns
ra is ed i n the ar

ti cl e, C entoc or ’s “ Communica ti ons Prog ra m” re cog niz ed th at t he N ew England Journa l of

Medicine “traditio nally garners sig nif icant m edia a t t ent ion,” w hich inc lud es mult ipl e sto ri es filed by the Ass oci ated Press
. Cen toc or ’s mar ket ing pl an s tates
as it s obj ect iv es: (1 ) neutrali z e the commerci al impact of t he publ ic ati on, ( 2) co nfine t he sto ry to one news cy cl e, and (3) prov ide context t o the st or ies thatappear
. Fur ther more, Cen toc or pla nned to “[ d]ec re ase/ eli minat e news v alu e by pre- posi ti oni ng data as a ‘ nonsto ry ’ w it h k ey

medi a.” D r. M atthe w s t est ified thati t w oul d be “h ig hly unusu al” for a dr ug67

company

to under tak e s uch a prog ra m to dil ute the effect of a neg ati v e peer rev iew ar ti cl e. Al l thi s e v ide nce ind ic ates an i ntentby C entoc or

to ind uce pati ents , l ik e Pat ri ci a, t o
re ly o n i t s ma r k e t i n g ma t e r i a l s , w h i c h o mi t t e d s i g n i fi c a n t r i s k i n fo r ma t i o n , a n d to s eek treat me nt w ith Rem icade . Centoco r does no t add ress any of this test imo ny, w hich w e ho ld is le ga ll y a n d fa c t u a ll y su f f ic ie n tt o su p p o rta f in d in g o f f ra u d u le n tin t e n t

. Ac c o rd in gl y, we
ov er ru le Cen toc or ’s fourt h i ss ue. VI. E VI DENCE OF F U TU R E D A M A GES The ju ry aw arded Pa tr ici a $ 1 mi ll ion i n damag es for physi cal pai n and mental ang uis h tha t, in re asona ble probabi li ty , Patr ic ia w il l sus tai n i n the future. By i ts tenth i ss ue, Cento cor argues thatthe e vid ence is l egally and factu ally

insuf f icient to supp ort the se dam ages. First, Cento cor cont end s tha t Pat ricia’s lupu s-like sy ndro me w as a tem pora ry si de effect tha t c eased w hen Pa tr ic ia sto pped t aking R emic ade, and t hat t here w as no evidence th at th is sy mp tom w ould spon tan eou sly reoccu r. Cento cor argues tha t the re is
no ev ide nce that Patr ic ia w il l suffer any physi cal pai n i n the f uture rel ated to her Remi cade treatments

. Seco nd, C entoc or arg ues that there i s n o ev ide nce of future mental ang uis h. It notes thatPat ri ci a di d nottes ti fy that she w oul d s uffer mental angu ish i n the future, except tha t she feare d ad v erse react ions in the f utu re unrel a t e d t o he r lupus-like sy ndro me . In respon se, Pa tricia arg ues th at a p laintif f nee d no t presen t direct evidence of the nat ure, du ra ti on, o r sev er ity of her mental ang uis h in order to re cov er becau se she suffered s ev ere pai n and dis abi li ty in the past

. W e ag re e w it h Cen toc or and re v erse the
aw ard of future pai n and mental ang uis h. A . A pp licab le L aw68

W e ap ply the tradition al legal and factu al suf f iciency stan dard s outline d ab ove in Part IV. A. T o supp ort an award of m ent al anguish dam ages, the plaintif f ’s ev iden ce mu st d e sc rib e "t h e na tu re , d u ra ti o n , a n d se veri ty of th e ir m e n ta l a n g u i s h , t h u s e st a b lis h in g a subs tanti al dis ru pti on i n the pl ain ti ffs' dai ly routi ne." S e e F

i f t h Clu b , In c
. v

. R a m i r e z, 196 S.W .3d 7 88, 7 97 ( Tex . 200 6) ( q u o t in g Par kway Co. v. Woodruff

, 901 S. W .2d 4 34, 4 44 (Tex . 199 5) ). The Tex as Supreme C our t has hel d th a t " some ty pes of dis tur bin g or shoc ki ng i nju ri es hav e been found suff ici e n t to s uppor t an inference that the i nju ry w as
acc ompani ed by

mental ang uis h." Par

kway, 901 S.W .2d at 445. For ex ample, as ear ly

as 188 8, th e T exas Suprem e Court recognized tha t serious bo dily injury “inv olvi ng fract ures, dislocat ions, e tc.” thatresult in “protracte d disab ility and conf inem entto bed ” necessa rily
re sul t i n s ome deg re e of phy si cal a n d m e n ta l sufferin g
. See B ro wn v. Sul livan , 7 1 T e x. 4 7 0 , 1 0 S

. W

. 2 8 8 , 2 9 0 ( 1 8 8 8 )

. To s u p p o rta n a w a rd fo r fu t u re m e n t a l a n g u i s h , a p l a i n t i ff must demonst ra te “ a reason abl e probabi li ty ” thathe o r she w il l “s uffer co mpensabl e mental anguish in th e f utu re.” Adam s v . YM CA of San A ntoni o, 26 5 S

. W

. 3 d 9 1 5 , 9 1 7 (T e x. 2008)

. In Ra mirez , t h e Te x a s S u p re me C o u rt a p p l i e d t h e fo re g o i n g r u l e s t o a n a w a rd of future mental ang uis h damag es. 196 S.W .3d a t 797

. Rami re zatt empted t o ent er a ni g ht cl ub and eng ag ed i n an alt ercat ion w it h a p ri v ate s ecur ity guard wor ki ng at the n ig ht c lub

. Id. at 790 . Th e secu rity g uard slamm ed Ram irez ’s h e a d a gainst a w all, knockin g him
u n c o n s c i o u s , a n d t h e n s t r u c k h i m s e v e ra l t i me s. Id. Ramirez’s skull w as f ractured as a
re sul t, and he suffered ot her i nju ri es as w ell

. Id. Ram irezsued the club and claimed f utu re mental ang uis h damag es. Id. O n appeal, the cl ub arg ued that there w as no ev ide nce to69

suppo rtthe aw ard of future damag es. Id. at 797 -98. T he T exas S upre me Court
sum ma riz ed th e evidence on m ent al anguish as follows: Rami rez a n d h is w ife tes ti fied th at R amirezco nti nued t o be depress ed, humil iat ed, n on- communi cat iv e, un abl e to sl eep, and ang ry , c onti nued t o have hea dach es an d nightm ares, an d tha t hi s dailyactiv ities and his relation ships w ith hi s wife an d da ughter con tinue d to be detrim ent ally a f fect ed al most two y ears a fter t he i nci dent. R amirezal so present ed ev ide nce of the s ev er ity of the i ntent iona l b e a ting by W est , i ncl udi ng significan t injuries to his he ad a nd b ody, h is loss of consciou sness, and his v is it s t o the h o sp it al. The ev ide nce shows t he nat ure of Ra mirez 's mental anguish, its lasting dura tion, and the severity of his injuries, and is the refore legally suf f icient to supp ort f utu re me nta l anguish dam ages. Id. Th e c ou rt ac k no w l ed g ed th at th ere w as no di rect ev i de nc e th at R am i rez w ou l d, i n
re asona ble probabi li ty , s uffer co mpensabl e mental a ng uis h i n the future, bu t i t hel d tha t the severe beat ing received by R am irezprovi ded an adequa te basis for the jury to reason abl y

co ncl ude t hat h e woul d c ontinue t o s uffer su bst anti al disrupt ions i n his daily routin e of the kind described in his a n d h is wife's testim ony that he had alread y suf fered in the past

. T he e v iden ce in this case amounts t o f a r more than w or ry thatmedi cal bi ll s mi g ht no t g et pa id

. . . or that someone is di stu rb ed and upset

. . . . Id. at 798. B. Lu pu s- like Sy nd ro me Pat ricia does no t dispu te t h a taf ter she sto ppe d takin g Rem icade , her lupu s-like sy ndrome, and the pai n assoc iat ed w it h it, w ent a w ay
. There w as no te sti mony present ed
a tt ri a l t h a tlu p u s -l ik e syn d ro m e wo u ld re a p p e a r a f t e r d is c o n t in u in g R e m ic a d e t h e ra p y. Nev erthel ess , Pa tr ic ia arg ues that her pain and temporar il y

disabl ing inju ri es are m ore tha n adeq uate to s uppor

t t he jur y ’s f uture damage aw ard. Rel y ing on Ram ir ez , Pa tr ic ia arg ues t h a tsh e d id n o th a ve t o p re s e n td ir e c te vid e n c e t h a tsh e wo u ld , in re a s o n a b le p ro b a b il it y,70

s u ffe r me n t a l a n g u i s h i n t h e fu t u re b e c a u s e t h a t i s n o l o n g e r re q u i re d w h e n a pl ain t i ff suffers personal i nju ri es. W e di sag re e tha t Ram ir ez st ands for th at proposi ti on. Al thoug h Pat ri ci a s uffered pai n and dis a b ili ty w hil e on Remi cade, the pai n and suffering she felt sto pped on ce the R emic ade di sc onti nued. M oreov er , Pa tr ic ia did not presentany

tes ti mony re g ardin g the mental ang uis h that she suffered after sh e s topped taking Remica de, if an y , or thatshe an ticip a ted men tal an guish in the f utu re. Pat ricia’s injuries certain ly

supp ort an inferen ce tha t she suf fered p hysical pa in and m ent al anguish in the p ast , and C entoc or does not dis pute that, but her i nju ri es w e re n ot t he s ort of “s hock ing ” inj ur ies thatwoul d s uppor t an inference of f uture mental ang uis h. Cou rt s h av e al lowed an inference of f uture mental ang uis h i n c ases i nv olv ing the
ser iou s i nju ry

or deat h of a f a m ily m ember

and mis handl ing of a c or pse. See Par kway, 901 S. W .2d a t 445 ; s ee al s o Se r v . C or p. In t’ l v . Gue rra , N o
. 1 3
- 0 7
- 0 0 7 0 7
- C V , 2 0 0 9 WL 3210940, at *4 ( Tex . Ap p.–C or pus Chr is ti Oct. 8, 2009, pet. fil ed) ( mem. op.)

. In Ibrah im
v. Young, the E ast lan d C our t of Appea ls opi ned t hat R a m i r e z doe s not extend this inferen ce to ev ery perso nal i njury case claiming f utu re dam ages, butonly to th ose in which the i nju ri es are “s hock ing ” or “d is tur bin g .” 253 S.W .3d 790, 807 ( Tex . Ap p.–Eas tl and 200 8, pet. deni ed)

. In Ib ra h im, the pla int iff sued her employ er

and a f ur nit ure manufact urer for inj ur ies sh e s ust ain ed w hen her off ic e c hai r broke and s he fell

. Id. at 795. She re cei v ed
an aw ard of future mental ang uis h damag es, but she prov ide d no directev ide nce to s how that she w oul d suffer mental ang uis h damag es in the future. Id. at 807. On appeal , s he
e qua ted h er

i nju ri es w it h tho se suffered by the pla int iff in Ram ir

ez
. Id. a t 8 0 6. The East lan d C our

t of Appea ls hel d tha t71

Fi fth Club does not s tand for th e propos it ion that mental ang uis h damag es can be i nferred i n al l personal injur y ca ses
. The cour

t' s h old ing w as premis ed on the ex is tenc e of a di stu rb ing or

sh ock ing i nju ry
. Fal li ng off of an off ic e c hai r is not the ty pe of sho ck ing or di stu rb ing i nju ry

thatw e bel iev e the supreme co urt had i n mi nd. Id. at 807. W e a g re e t h a t Ra mir

ez , and othe r cas es in w hic h future mental ang uis h c an be presumed, are dis ti ng uis habl e from Patr ic ia’ s fraud c lai m. P atr ic ia’ s i nju ri es w ere notas “s hock ing ” or

“ dis tur bin g ” as los ing a famil y member , hav ing a c or pse mis han d le d , or hav ing a s kul l crack ed by bei ng sl ammed i nto a co ncre te wa ll. In the absen ce of any testim ony abou t me nta l anguish and physi cal pain she would suf fer in the f utu re, the aw ard of f uture damag es must be rev ersed. C. Li v er I nj ur

y Al ong w it h her

cl aims based on lup us- li ke sy ndrome, Pa tr ic ia spenta l arg e amount of time a t trial arg uing thatCento cor misrepre sent ed th e risk of i n ju ry t o he r li v er, and it faile d to w ar n her

thatR emic ade coul d w orsen her pre- ex is ti ng hepatit is C

. Patr ic ia arg ues th atR em i c ad e altere d he r D N A i n a ma nn er

t ha t ren de rs h er

i ne l i g i bl e to t ak e s om e transpl ant medi cat ion s i n the future, i n the ev ent s he ev er needs a l iv er

tra n splant. Sh e did not presentany

ev ide nce, how ev er , t hat s he actual ly su ffered any

i nju ry to her l iv er as
a resu l t of R em i c ad e, th at s he w ou l d l i k el y ne ed a l i v er tran s pl an t, or th at s he w ou ld, in
re asona ble probabi li ty , s uffer any i nju ry i n t h e f uture as a resul t of R emic ade. C entoc or argues tha t und er Tem

ple -Inla nd For

est Pr oduct s C or p. v . C ar ter , Patr ic ia cann ot ba se her
aw ard of fu tu re pai n and sufferin g or future mental ang uis h on her “ fear” thatsh e mi g ht suffer an adv erse ev ent in the future that has not present ly manifest ed. See993 S.W .2d72

88, 9 3 ( Tex . 199 9)

. W e ag re e. In Car ter , th e T e xas S upreme C our t hel d tha t wor kers w ho w ere ex posed to asbes tos co uld not re cov er damag es for th eir

fear of the pos si bil ity of dev elo pin g an asbes tos -rela ted inj ur

y in the future. Id. The cour t ex pla ine d the pol icy

behi nd th is hol din g as follows: In al most all i nst ances i nv olv ing person a l injur y , t he l aw

al lows for

the re cov er y of acc ompany ing mental ang uis h damag es, e ven i f the mental anguish is notitself

physically

man ifeste d. Butif

b o d il y injury

is at most laten t and any eventua l conse quence s unce rtain, as w hen a p e rson's exposure to asbe stos has notp rodu ced disea se, th en th e case for recovery of mental ang uis h damag es is much w eaker

. A pers on ex posed to asbes tos can cer tai nly dev elo p s er iou s h eal th probl ems, but he or sh e al so maynot. The difficul ty in predi cti ng w hether ex posure w il l caus e any dis ease and i f so, w hat d is ease, and the l ong lat ency per iod ch aract er is ti c o f asbes tos -rela ted disea ses, m ake it very dif f icult for ju d ges and juries to e v alua te w hich ex posure c lai ms are s er iou s a nd w hic h are not

. This diff ic ulty i n tur n make s liability unp redicta ble, wi th som e claims resu lting i n significa nt recovery w hile v ir tual ly i ndi sti ng uis habl e c lai ms are de nie d al tog ether

. Some c lai mants w oul d i nev it abl y

be o v ercompens ated w hen, in the course of time, i t hap pens that th e y nev er

dev elo p the di seas e the y feared, and others woul d be und ercom pen sate d w hen it turns out th at th ey develope d a d is e a se mo re ser iou s e v en t h a n t hey feared. Al so, cl aims for e x posure c oul d proli ferate becau se in ours o ciety , as the Supreme C our t obs er v ed, “ cont act s, ev en extensive contact s, w ith serious ca rcinogens are com mo n.” In d eed , mo st Amer ic ans are dai ly subj ect ed to tox ic subs tanc es in the a ir they breathe and the foo d t h e y e a t. Suits for me nta l anguish dam ages cause d by ex posu re tha t has no t resulted in disease w ould comp ete w ith s u it s for ma nifest dis eases for t he l eg al syste m's l imi ted resources
. If rec ov er y w ere al lowed in the abse nce o f

presen t disea se, i ndividuals might fee l obliged to bring suit for such recovery

proph y lactically, against th e po ssibilit y o f f utu re cons eq uence s from w hat i s n ow an i nchoa te ri sk

. This w oul d ex acer bate not only the mu ltiplicity

of suits but th e un pred ictability of results. Id. For the same reason s, w e ho ld tha t Patricia’s f utu re pain a nd m ent al anguish award
canno t be predi cat ed on her fear of dev elo pin g a li v er inju ry , w hen s he di d notpresentany evidence o f

a prese nt i njury to her liv er. Furthe rmore , her fear tha t she m ay notbe ab le to t ake transpl ant medi cat ion i s p re mis ed on the ide a that she w il l need a transpl ant i n the73

future, w hic h s he di d notprov e. Ac co rd ing ly , w e s ust ain C entoc or ’s tent h i ss ue and
rev erse the aw ard of

f utu re pain a nd m ent al anguish da ma ges. VII. T ho mas’ s D erivat ive C laim s B y it s e le ve n t h is s u e , Ce n t o c o r a rg u e s t h a tb e c a u s e T h o m a s ’s c la im s a re d e ri va t ive of Patr ic ia’ s c lai ms and Pat ri ci a c annot re cov er , w e mustrev erse the a ward of los s o f
conso rtium and house hold serv ices to Tho ma s. Beca use w e have susta ined Patricia’s f raud cl a im , howev er, Cento cor’s arg um enthas no merit. Accord ingly , w e overrule Cen toc or ’s el ev enth is sue. VIII . Pun it ive D amag es B y it s twe lft h i s s u e , Ce n t o c o r a rg u e s t h a tt h e t ri a l c o u rtm is a p p li e d t h e p u n it ive damag es cap w hen c alc ula ti ng the final damages

. Spec ific all y , C entoc or co mplai ns that the t ri al cour

t app li ed th e c ap to the total damag es aw arded t o the H amil tons w it hout tak ing int o acc ount that Cen toc or w as onl y found 85% li abl e for the damag es. The Ha mil tons do notdisput e tha t the caps ap ply t o the judgmen t butargue that(1) C ent ocor w aived this
arg ument be caus e i t nev er rais ed i t in the tri al cour t, and (2) the tr ial co urt proper ly appl ied the caps. The ju ry awarded Pa tr ic ia $1.2 mil li on for pastpai n and mental ang uis h, $1 mil li on for future pai n and mental ang uis h, $1 .1 mi ll ion fo r p a st phy si cal i mpair ment, and $65 ,90 8.0 0 in pastmed ical care expense s. Th e jury aw arde d T hom as $50 ,00 0.0 0 for loss of cons orti um and house hol d serv ic es. T he tr ial co ur t app li ed th e formul a s et ou t i n s ect ion 41.008 of the c iv il pract ic e and re medies co de, w hic h al lows recov er y of tw o ti mes t he amount o f economi c damag es plu s a n amounteq ual to any non- econo micdamag es foundT he pr i or , 2001 v er si on of t hi s st at ut e ap pl i es t o t he Ham i l t ons’ cl ai m s. W e no t e, howev er , t hat t he 22 s ta tu to ry a m e n d m e n ts s i n c e 2 0 0 1 h a v e n o t a l te re d th e d a m a g e c a p a m o u n ts

. C om pa re Act of M ay 21, 200 1, 77t h Le g. , R

. S. , ch. 643 , § 3, 200 1 T EX
. S ESS
. L AW
. S E RV . 1 1 3 6 , 1 1 3 7 (V e rn o n 2 0 0 1 ); w i th Act of June 2, 200 3, 78t h Le g. , R

. S. , ch. 204 , § 13. 06, 200 3 T EX
. S ESS
. L AW
. S E RV . 8 4 7 , 8 8 8 (V e rn o n 2 0 0 3 ); w i th Act of M ay 17, 2007, 80t h Le g. , R

. S. , ch. 593 , § 3. 03, 200 7 T EX
. S ESS
. L AW
. S E RV . 1 1 2 2 , 1 1 3 2 (V e rn o n 2 0 0 7 ). 74 by the jur y , not t o ex ceed $750,00 0. See T EX
. C IV
. P R AC
. & R EM
. C OD E § 41. 008 ( Ver non Supp. 2009)

. The econo micdamag es w ere $65, 908, w hic h w as doubl ed to $131, 816.

22 Then the tr ial co urt add ed $750 ,000, for a total aw ard of $8 81,816. 00 in puni ti v e damag es to t he H amil tons

. Assum ing that Cent ocor prop erly p re s e rv ed th is issue, the trial court prope rly appl ied the ex emplar

y damag es cap. Ex emplar y damag es are calc ula ted o n a p er defendant basi s. See Sem ino le Pi pel ine Co. v. Br

oad Leaf Par

tner s, Inc ., 979 S. W .2d 7 30, 751- 52 ( Tex . Ap p.–H oust on [1 4th D is t.] 1998, no p et.) ; see a lso W acken hut

Corp. v. De la Rosa , No. 13- 06- 00692- CV , 2009 W L 866791, at*48 ( Tex . Ap p.–C or pus Chr is ti Apr . 2, 2009, no pet.)

. The Four teent h Cou rt of A ppeal s i n Sem ino le Pi pel inerelied on th e plain lan g uag e of the sta tute, w hic h, at that ti me, sai d that “e x emplar y damag es aw arded aga inst a def endant may note xceed four

ti mes t he amountof act ual damag es. ” 979 S.W .2d a t 751. The c ur re nt v ersi on k eeps the s ame l ang uag e e xce p t chang es the a mount of the cap. See T EX
. C IV
. P R AC
. & R EM
. C OD E § 41.008( b)

. The cour t furt her reli ed on sta tements by the st a tu te ’s l eg is lat iv e s ponso r, w ho prov ide d the foll ow ing ex ample of how the cap shoul d appl y , and i ndi cat ed th at t he c ap appl ies w it hout re fere n ce t o the propor ti on of li abi li ty as si g ned t o a p arti cul ar defendant: The pl ain ti ff 's actual damag es are $100, 000. Pl ain ti ff is 20% respon si ble for the lo ss ; defendant A i s 3 0% respon si ble ; and defendant B i s 5 0% re spons ibl e. The jur

y imposes puniti v e damages agai nstdefendant A i n the amount o f $25 0,000 and ag ain st defendant B i n the amount of $1,000,0 00. A c c o rd in g t o S e n a t o r M o n tfo rd , t h e p la in t if f is e n t i t l e d t o co ll e c tp u n it iveI n it s r e m a in in g is s u e s , C e n to c o r c h a lle n g e s t h e a lte r n a tiv e b a s e s f o r th e ju d g m e n t. S p e c if ic a lly, 23 by i t s f i ft h i ssue, C ent ocorar gues t hat t he j udgm ent shou l d be r ev er sed b ecause Pat r i ci a’ s cl ai m s f ori m pl i ed m i sr epr esent at i on u ndersect i on 402B of t he R est at em ent (Secon d) ofT or t s, as st at ed i n Q uest i ons 3 and 4 of t he j ur y char ge, cannot be m ai nt ai ned because sect i on 4 02B onl y app l i es t o exp r ess m i sr epr esent at i ons. By i t s si xt h i ssue, i t ar gues t hatt hose cl ai m s f ai l on t he ev i dence. C ent ocor ar gues i n i t s sev ent h i ssue t hat t he Ham i l t ons’ neg l i gence cl ai m s shou l d be r ev er sed b ecause Pat r i ci a f ai l ed t o pr esent exper t t est i m onyon t he st andar d of

car e an d br each oft hat st andar d. Byi t s ei ght h i s s ue, C ent ocorar gues t hat neg l i gent m i sbr andi ng i s notr ecogni z ed a s a cause ofact i on i n T exas. Cent ocor ’ s ni nt h i ssue a r gues t hat t he di s t ri bu t i on o f a vi de otap e do es n ot c on s t i t ute a n eg l i ge nt un de rt ak i ng as a m att er of l aw
. Be c au s e w e h ave s u s ta i n e d th e v e rd i c t o n P a tri c i a ’ s fr a u d c l a i m , w e n e e d n o t a d d re s s th e s e i s s u e s
. See T EX
. R. A PP
. P. 47. 1. 75 damag es of $6 50,000, namely , $250,00 0 from defendant A an d $400, 000 (4 x $100, 000) from defendantB. Sem ino le Pi

pel ine , 979 S

. W

. 2 d a t 751 n.21 . Accordingly , w e ho ld tha t the trial court proper ly appl ied the puni ti v e damag es cap, and w e ov er ru le Cen toc or ’s tw elfth i ss ue. IX. Conclusion 23 W e hav e ov er ru led Centoc or ’s chall eng es to t he j udg ment on the H amil tons ’ fraud claim, ex ceptthatw e ha ve su staine d Cent ocor’s challen ge to the $ 1 million f utu re damag es aw ard. W e modi fy the j udg ment ag ain stC e n to cor to del ete t he aw ard of $1 mil li on i n future pai n and mental ang uis h damag es, and w e aff ir m the j u d gm e n t as modified

.

Lin da R . Y añez J u s t i c e

Del iv ered and filed the 4 th da y

of Ma rc h, 20 10.