2009 D e c i sion s O p inion s of the U nit e d S t at e s C our t of Appe al s for the Thir d C ir c uit 7-24-2009 

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A p p e llan ts v. BAXTER HEALT HCARE CORP ORATI ON; THE AM ERI CAN RED CROS S ; DR. GLE NN D UBOV; R. N. NURSE J AYSHE DOE, l a s tn a me b e i n g f i c t i t i o u s ; ROBER T W O O D J O H N SO N H O SPITA L ; J O H N D O E S 1- 5, s ai d names be i ng fi ct i t i ous

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( O pi ni on Fi l ed: J ul y24, 2009)

_________ OP I NI ON

_________ P E R C UR I AM C oll een M aryG robel nyand R ob ertG robel ny , w i fe an d h usban d, app eal pro seT here i s som e qu est i on regar ding w hich preci se produ ctC oll een recei ved . S he fir st 1 al l eged thats he w as gi ven ei t herB axt er ’ s G amm agar d S/ D ort he R ed C r os s ’ s Pol y gam S/ D . She l at ercl ai m ed t o have i dent i fi ed the l otnum berof the I G I V t r eatm entas cont ai ni ng Pol y gam, butdefe ndant s cl ai m t hatt hatl otw as notcl ear ed forr el eas e unt i l t he m o n th af ter she rec eive d the trea tm en t. In a n yev en t, the w arn ing s fo r bo th G am m ag ard a n d P o lyg a m a re c o n ta in e d in th e re c o rd a n d th e o p e ra tiv e la n g u a g e o f e a c h is id e n tic a l. T he def endant s and the D i s t r i ctC our tt hus as s um ed thatC ol l een r ece i ved Pol y gam as p la in tif f s a s s e rt , a n d s o w ill w e . 2 fro m the D istri ct C o u rt ’s en tryo f su m m aryjud g m en t i n fa v o r of B ax ter H ea lth ca re C orpor at i on ( “B axt er ”) and The A m er i can Red C r os s ( t he “Red C r os s ”) . Fort he f o l l o wi n g r e a s o n s , we wi l l a f f i r m. I. T h e G ro b e ln y s w e re re p re se n ted b yc o u n se l at a ll rele v a n t ti m e s p rio r to th is appea l . I n 2005, t heyfi l ed a c om pl ai nti n t he N ew J er s eySuper i orC our tforM i ddl es ex C ount y , al l egi ng t hatC ol l een s uffe r ed s ever e adve r s e r eac t i ons t o i nt r avenous i m m unogl obul i n ( “I G I V ”) t r eatm ent s admi ni s t er ed on February7 and 8, 2002. H er t r eat i ng phy s i ci an, D r . B runo Fang, pr es cr i bed thos e tr eatm ent s i n pr epar at i on fort he r emoval of hers pl een, w hi ch D r . Fang r ecomm ended t o combata bl eedi ng di s or dercal l ed I di opathi c Thrombocyt openi c Purpur a ( “I T P”) . T he tr eatm ent s caus ed hert o s uffe r m u lt iple “thro m b o ti c e v en ts”— i. e., the f o rm ati o n o f b loo d clots in a b loo d v esse l, artery orvei n. T hos e eve nt s r es ul t ed, i nt eral i a, i n t he perm anentr educt i on of herl eftki dney f u n c tio n a n d a p u lm o n a ry e m b o lis m . A m on g the defen dan t s nam ed in the co m plai nt w ere B axterand t he R ed C ross , w h ic h a lle g e d ly m a n u f

a c tu re d a n d d is tr ib u te d th e IV IG tr e a tm e n t a t is s u e , a n d D r. F a n g . 1D efe ndant s r enew t hi s ar gum enton appea l . I n l i ghtof ourdi s pos i t i on, w e nee d not 2 re a c h it. 3 P lai n ti ff s all eg ed that B ax ter an d the R ed C ross fa il ed to ad eq u atelyw arn o f th e IV IG tre a tm e n t’s p o ten tial a d v e rse re a c tio n s a n d th a t D r. F a n g c o m m itt e d m a lp ra c tice in var i ous r es pect s . T he s t at e courtdi s m i s s ed the cl ai m s agai ns tD r . Fang for noncompl i ance w i t h N ew J er s ey ’ s aff i davi tof m er i tr equi r ement , N . J . S. A . 2A : 53A - 27, and t w o o t her defen dan tph y si ci ans w ere di sm i ssed i n st at e cou rtas w el l . T he R ed C ross , aft erl at erbei ng s erved w i t h t he compl ai nt , t i m el yr emoved t he s ui tt o fede r al cour tunder 2 8 U .S .C . § § 1 4 4 1 a n d 1 4 4 6 p u rs u a n t to th e te rm s o f its f e d e ra l c h a rt e r. S e e 3 6 U .S .C . § 300105( a) ( 5) ( form er l y36 U . S. C . § 2) ; A m er i can N at ’ l R ed C r os s v. S. G . , 505 U . S. 247, 2 5 7 (19 9 2 ); D o e v . A m erican R ed C ross , 1 4 F . 3 d 1 9 6 , 1 9 7 -98 (3d C ir . 1 9 9 3 ). T h ere af ter, pl ai nt i ffs vol unt ar i l ydi s m i s s ed thei rcl ai m s agai ns tal l r emai ni ng defe ndant s exce pt B a x te r a n d th e R e d C ro s s . B axt erand the R ed C r os s fi l ed a mot i on fors um m aryj udgm ent , ar gui ng t hatt he w arni ngs t heyi s s ued had be en appr oved byt he Food and D rug A dm i ni s t r at i on, t hats uch w arni ngs w er e thus pr es um ed ade quat e underN ew J er s eyl aw , s ee N . J . S. A . 2A : 58C - 4, and thatpl ai nt i ffs had fa i l ed t o pr es entevi dence s uffi ci entt o r ebutt hatpr es um pt i on. 2 P lai n ti ff s o p p o sed the m o ti o n , an d to the irresp o n se a tt ac h ed the re p o rto f th eir ex p ert, D r. J ohn N . D . W urpel , w ho opi ned thatt he I V I G tr eatm entcaus ed C ol l een’ s i nj ur i es but offe r ed no opi ni on on t he ade quacyof the w arni ngs . T he D i s t r i ctC our tdeni ed defe ndant s ’ m ot i on byor derent er ed A ugus t12, 2007, aft erfi ndi ng, i n an or al opi ni onT he oper at i ve or deri s docket ed atD ocketN o. 55 and s t at es t hati ts uper cede s t he 3 or derdat ed M ay22, 2008, and docke t ed atD ocketN o. 54. 4 r ender ed on A us t3, 2007, t hatdefe ndant s had pr es ent ed no pr oof thatt he w arni ngs had b e e n a p p r o v e d b yt h e F DA. D e f e n d a n ts m o v e d f

o r re c o n sid e ra tio n , arg u in g th a t p lain tiff s w e re re q u ire d to s uppor tt hei ri nadequa t e w arni ng cl ai m w i t h expertt es t i m onybutt hatD r . W urpel had o ff ere d n o o p inion o n that issue . B yo rde r en tered A p ri l 7, 20 0 8 , the D istri ct C o u rt co n clud ed that ex p ert t esti m o n yw as in d ee d req u ir ed to sh o w that the w arn ing s w ere i nadequa t e. T he D i s t r i ctC our tal s o cons t rued def endant s ’ m ot i on forr econs i der at i on as “more aki n” t o a mot i on i n l i m i ne and s chedul ed a D auberthear i ng, s ee D aubertv. M err el l D ow Phar m s . , I nc. , 509 U . S. 579 ( 1993) , atw hi ch i tdi r ect ed pl ai nt i ffs t o pr offe r D r . W u rp e l ’ s t e s t i m o n y. T he hea r i ng w as conduct ed on M ay15, 2008, and the D i s t r i ctC our tent er ed an o p inion an d o rde r on M ay2 3 , 2 0 0 8 . T h e D istri ct C o u rtruled o n ce ag ain th at ex p ert 3 t es t i m onyw as r equi r ed t o demonstr at e the i nadequa cyof the w arni ngs . T he D i s t r i ct C our tfur t herrul ed thatD r . W urpel w as qual i fi ed t o t es t i fyt hatt he I V I G t r eatm entcaus ed C ol l een’ s i nj ur i es and t o “expl ai n t echni cal as pect s ” of the w arni ngs , s uch as defi ni ng t he relev an t t erm s, b u t no t t o o ff er a n o p inion o n their ov era ll ad eq u ac y . T h e D istri ct C o u rt co n clud ed , h o w ev er, th at plaintiffs c o u ld m ee t th eir bu rde n o f p roo f w ith D r. W u rpe l’ s t es t i m onyi n conj unct i on w i t h t he expe ct ed fa ctual t es t i m onyof D r . Fang ( t he tr eat i ng p h y sic ian , w h o m th e sta te c o u rt h a d d ism iss e d a s a d e f e n d a n t) re g a rd in g h isT h e tra n sc rip t o f th e a rg u m e n t an d th e D istric t C o u rt’s o ra l ru lin g e rro n e o u slyre f e rs to 4 D r. F a n g a s “ D r. F ra n k ” th ro u g h o u t. 5 under s t andi ng of the w arni ngs . ( T he D i s t r i ctC our tw r ot e thatpl ai nt i ffs ’ couns el had m ade ce rt ai n represent at i on s t o itabo ut D r. F ang ’s exp ect ed tes t i m on y . T ho se re p re se n tatio n s d o n o t ap p e a r o f re c o rd , an d d e f

e n d a n ts s tate th a t th e yw e re “ n o t p riv y ” to th e m .) T her eaf

t er , t he part i es depos ed D r . Fang. D efe ndant s t hen r enew ed thei rm ot i on fors um m aryj udgm ent , ar gui ng t hatD r . Fang’ s t es t i m onydemonstr at es t hatt he w arni ngs w e re a d e q u a te a n d th a t p lain tiff s h a d p re se n ted n o e v id e n c e to th e c o n tra ry . D e f e n d a n ts fi l ed thei rm ot i on on J ul y16, 2008, r eques t i ng t hatt he D i s t r i ctC our thearar gum enton Ju ly1 8 , 2 0 0 8 (th re e d a y s b e f o re th e c a se w a s s c h e d u led f o r tria l). P lain tiff

s’ c o u n se l d id notfi l e a br i ef i n oppos i t i on ors ubm i tanyaddi t i onal document s t o t he D i s t r i ctC our t , but h e d id n o t o b

je c t to th is p ro c e d u re a n d th e p a rt ie s p re s e n te d o ra l a rg u m e n t o n J u ly 1 8 . T he D i s t r i ctC our tgr ant ed def endant s ’ m ot i on fr om t he benc h t hats ame day . Pl ai nt i ffs 4 a p p e a l. II. W e h av e jurisdicti o n u n d er 2 8 U . S . C . § 1 2 9 1 . “O u r rev iew o f th e D istri ct C o u rt ’s deci s i on i s pl enary , and w e appl yt he s ame st andar d as t he D i s t r i ctC our tt o det erm i ne w h e th e r su m m a ryju d g m e n t w a s a p p ro p ria te. A g ra n t o f su m m a ryju d g m e n t is appr opr i at e ‘ i f the pl eadi ngs , t he di s coveryand di s cl os ur e mat er i al s on fi l e, and any aff i davi t s s how t hatt her e i s no genui ne i s s ue as t o anym at er i al fac tand thatt he movant6

is en ti tl ed to jud g m en t as a m att er o f law . ’” S tat e A u to P rop . & C as. Ins. C o . v . P ro D es i gn, P. C . , 566 F. 3d 86, 89 ( 3d C i r . 2009) ( quot i ng Fed. R . C i v. P. 56( c) ) ( i nt ernal c itatio n o m itt e d ). In re sp o n se to a p ro p e rly -su p p o rte d m o tio n f o r su m m a ryju d g m e n t, “the non- m ovi ng par t ym us tpoi ntt o s om e evi dence i n t he r ecor d t hatcr eat es a genui ne i ssue of m at eri al fact ” and “m ustrebutt he m oti on w i t h fac t s i n the r ecord an d can no tres t s ol el yon as s er t i ons m ade i n t he pl eadi ngs , l egal m emora nda, oror al ar gum ent . ” B er ckel eyI nv. G r oup, L t d. v. C ol ki t t , 455 F. 3d 195, 201 ( 3d C i r . 2006) ( ci t at i ons om i t t ed) . O urpl enaryr evi ew i s nece s s ar i l yl i m i t ed t o t he r ecor d t hatw as befor e the D i s t r i ctC our t . See C averv. C i t yof Tre nt on, 420 F. 3d 243, 257 ( 3d C i r . 2005) ; Fas s et tv. D el t a K appa Epsi l on ( N ew Y or k) , 807 F. 2d 1150, 1165 ( 3d C i r . 1986) . W e r evi ew t he D i s t r i ctC our t ’ s rul i ngs r egar di ng t he admi s s i bi l i t yof expe r tt es t i m onyforabus e of d iscreti o n . S ee P ined a v . F o rd M o tor C o . , 5 2 0 F . 3 d 2 3 7 , 2 4 3 (3d C ir . 2 0 0 8 ). T he part i es and the D i s t r i ctC our tas s um ed thatt hi s cas e i s governed byt he s ubs t ant i ve l aw of N ew J er s ey , w her e the G r obel ny s r es i de and Col l een r ece i ved the t r eatm ent s ati s s ue, and w e s ee no ba s i s t o ques t i on t hatas s um pt i on. “[T] he N ew J er s ey P ro d u c t L iab ili tyA c t . . . is ‘th e so le b a sis o f re lief u n d e r N e w Je rse ylaw a v a ilab le to c o n s u m e rs in

ju re d b ya d e f

e c tiv e p ro d u c t.’ ” P o rt A u th . o f N .Y . & N .J . v . A rc a d ia n C o rp ., 1 8 9 F .3 d 3 0 5 , 3 1 3 (3 d C ir. 1 9 9 9 ) (c itatio n s o m itt e d ). T h e A c t p ro v id e s in re lev a n t p a rt: [T ]he m an u fa cture r or se ll er sh all n o t be liable f o r ha rm ca u sed b ya f

ail u re to w a rn if

th e p ro d u c t co n tain s a n a d e q u a te w a rn in g . . . . A n a d e q u a te pr oductw arni ng ori ns t ruct i on i s one thata r eas onabl yprudentper s on i n t he s ame ors i m i l arci r cumst ance s w oul d have pr ovi ded w i t h r es pectt o t heT h e N e w Je rse yS u p re m e C o u rt h a s h e ld th a t th is d o c trin e d o e s n o t ap p lyto 5 pharm ace ut i cal pr oduct s t hatm anufa ctur er s m arketdi r ect l yt o cons um er s , s ee Per ez v. W y eth L abs . I nc. , 734 A . 2d 1245, 1257 ( N . J . 1999) , butt her e has been no s ugges t i on t hat t he I V I G pr oductati s s ue her e qual i fi es fort hatexce pt i on. 7 dangerand thatcomm uni cat es adequa t e i nform at i on on t he dange r s and sa f e u se o f th e p ro d u c t, . . . in th e c a se o f p re sc rip tio n d ru g s, ta k in g in to acc ountt he cha r act er i s t i cs of, and the or di naryknow l edge c om m on t o, t he p re s c ri b in g p h y s ic ia n . N . J . S. A . 2A : 58- C - 4. T hi s pr ovi s i on codi fi es t he “l earned i nt erm edi ary ” doctr i ne, under w h ich “ a p h a rm a c e u tica l m a n u f a c tu re r g e n e ra llyd isc h a rg e s its d u tyto w a rn th e u lti m a te u ser o f p resc ri p ti o n d rug s b ysu p p ly ing p h y sici an s w ith inf o rm ati o n ab o u t th e d rug ’s d an g ero u s p rop en sit ies. ” N iem iera v . S ch n eide r, 5 5 5 A . 2 d 1 1 1 2 , 1 1 1 7 (N . J. 1 9 8 9 ). 5 A ccor di ngl y , t he cruci al ques t i on i s w hethert he w arni ng w as adequa t e t o appr i s e a p h y s ic ia n , n o t a c o n s u m e r, o f th e ri s k s . S e e id . W e agr ee thatpl ai nt i ffs fai l ed t o pr es entt he D i s t r i ctC our tw i t h evi dence on t hat ques t i on s uffi ci entt o r ai s e a ge nui ne i s s ue fort r i al . T he w arni ngs ati s s ue, cont ai ned i n a p a c k a g e in se rt, rea d in re lev a n t p a rt: 

### P r e c aut io ns G eneral T her e i s cl i ni cal evi dence of a pos s i bl e as s oci at i on betw een I m m une G lo b u lin In tr a v e n o u s (H u m a n ) ( IV IG ) a d m in is tr a tio n a n d th ro m b o tic e v e n ts . T h e e x a c t ca u se o f

th is is u n k n o w n ; th e re f o re , ca u tio n sh o u ld b e e x e rc ise d in t he pr es cr i bi ng and i nfus i on of I V I G i n pat i ent s w i t h a hi s t or yof cardi ov ascul ar di sease or throm bo t i c epis od es. *** 

### A dve r seR e ac ti ons8

*** In g e n e ra l, rep o rte d a d v e rse re a c tio n s to . . . P o ly g a m ® , in p a tien ts w ith ei t hercongeni t al oracqui r ed i m m unodefi ci enci es ar e s i m i l ari n ki nd and frequen cy . V ari ou s m i no r r eact i on s, such as h eadac he, fat i gu e, chil l s, backa che, l eg cr amps, l i ght heade dnes s , feve r , ur t i car i a, fl us hi ng, s l i ght elev ati o n o f b loo d p ressu re, na u sea an d v o m it ing m ayo cc asio n all yo cc u r. *** I di o pa t hi c Thr o mbo c yt o pe ni c Pur pu r a ( I TP) D u rin g th e c lin ica l stu d yo f P o ly g a m ® f

o r th e tre a tm e n t o f

[ IT P ], th e o n ly adver s e r eac t i on r epor t ed w as heada che w hi ch occ ur r ed i n 12 outof 16 p ati en ts ( 7 5 % ). (D e f s .’ M o t. f

o r S u m m . J ., R ic h a rd I. S c h if f , M .D ., P h .D . D e c la ra tio n , E x . 1 a t 6 -7 .) P l ai nti ffs argue t hat these w arni ng s ar e i nsuff i ci ent because t hey(1) l i m i tt he ri sk o f th ro m b o tic e v e n ts to p a tien ts “ w ith a h isto ryo f c a rd io v a sc u lar d ise a se o r th ro m b o tic e p iso d e s,” n e ith e r o f

w h ich C o llee n h a d , an d (2 ) c o n v e yth e im p re ss io n th a t th e o n ly pot ent i al adver s e r eac t i ons ar e mi l d ones s uch as heada ches , w hi ch w as t he onl yr epor t ed rea cti o n fo r th o se, l ike C o ll ee n , w ith IT P . T h e q u esti o n , h o w ev er, i s n o t ho w an o rdin ary cons um erm i ghthave r ead thes e w arni ngs , buthow a pr es cr i bi ng phy s i ci an w oul d r ead t hem, “t aki ng i nt o acc ountt he cha r act er i s t i cs of, and the or di naryknow l edge c om m on t o, t he pr es cr i bi ng phy s i ci an. ” N . J . S. A . 2A : 58- C - 4. T he D i s t r i ctC our tpr oper l yconcl uded t hatevi dence i n addi t i on t o t he w arni ngs t hemsel ves w as nece s s aryt o ans w ert hat ques t i on. T he D i s t r i ctC our tconcl uded thatpl ai nt i ffs coul d m eett hei rbur den w i t h ( 1) t he expe r tt es t i m onyof D r . W urpel r egar di ng t he meani ng of t erm s cont ai ned i n t he w arni ng s ( t ho ug h n ot theiradeq uacy ), and (2) t he tes t i m on yof D r. F ang , app arent l yas a fac tw i t nes s , r egar di ng hi s under s t andi ng of the w arni ngs . O n appea l , pl ai nt i ffs chal l engeD r . W urpel ’ s r epor toffe r s no opi ni on on t he ade quacyof the w arni ngs . Pl ai nt i ffs 6 quot e a port i on of D r . W urpel ’ s depos i t i on t es t i m ony , i n w hi ch he l at eropi ned that“I don’ tbel i eve thatt hes e w arni ngs . . . w oul d be s uffi ci entt o adequa t el yal er tt he phy s i ci an that thro m b o ti c e v en ts an d ren al ev en ts w ere h igh lyli k ely . ” T h at po rt ion o f D r. W u rpe l’ s depos i t i on i s notcont ai ned i n t he r ecor d, buthe t es t i fi ed t o t he s ame effe ctdur i ng t he D auberthear i ng. ( M ay15, 2009 T r ans . at23. ) H e al s o t es t i fi ed, how ever , t hat pharm ace ut i cal w arni ngs w er e notw i t hi n hi s expert i s e, t hathe has no exper i ence w i t h t he FD A orappl i cabl e r egul at i ons , and thathe i s nota cl i ni ci an and ha s neverpr es cr i bed m edi cat i on. ( I d. at27- 33. ) M or eover , he “w aff l ed” ( as t he D i s t r i ctC our tchar act er i zed i t ) on hi s opi ni on of the w arni ngs ’ adequa cy , and hi s fi nal w or ds on t he s ubj ectw er e that “ it’s d if f icu lt t o m a k e a n o p in io n .” (I d . at 5 1 .) F o r th o se re a so n s, th e D istric t C o u rt d id notabus e i t s di s cr et i on i n pr ecl udi ng D r . W urpel fr om t es t i fy i ng t o t he ade quacyof the w a rn in g s. C f. P in e d a , 5 2 0 F .3 d a t 2 5 4 & n .1 2 (h o ld in g th a t D istric t C o u rt a b u se d its di s cr et i on i n pr event i ng engi neerfr om t es t i fy i ng t o t he nec es s i t yof a w arni ng w her e no w arni ng w as gi ven, butopi ni ng t hati f pl ai nt i ff’ s cl ai m w as “thatan exi s t i ng w arni ng or instruction w as in ef

fe cti v e, m isl ea d ing , o r oth erw ise d ef ec ti v e, a tru e ‘w arn ing s’ ex p ert m igh t be re q u ir ed ”). 9 nei t hert he D i s t r i ctC our t ’ s rul i ng t hatexpertt es t i m onyw as r equi r ed nori t s pr ecl us i on of D r . W urpel fr om t es t i fy i ng as t o t he ade quacyof the w arni ngs , and w e per cei ve no err or i n those ruli ng s. 6 T hos e rul i ngs l eftD r . Fang’ s s t i l l - unr ece i ved t es t i m onyas t he onl yevi dence p o ten tiallyre lev a n t to th e a d e q u a c yo f th e w a rn in g s. P lain tiff s’ c o u n se l ap p a re n tly r epr es ent ed t o t he D i s t r i ctC our tt hatD r . Fang w oul d t es t i fyt hathe bel i eved the w arni ngs w er e i nadequa t e. D r . Fang, how ever , di d nott es t i fyt o t hateff ectathi s depos i t i on. I ns t ead, he t es t i fi ed that , befor e he pr es cr i bed I V I G t r eatm entforC ol l een, he had r ead the w arn ing s an d k n ew , b o th f rom the w arn ing s an d fro m o ther m ed ical sou rce s, that there w as an as s oci at i on betw een I V I G t r eatm entand thr om bot i c eve nt s . ( D efs . ’ R enew ed M ot . forSum m . J . , E x. 1 at15: 18- 16: 9, 17: 5- 9, 55: 21- 56: 2, 75: 6- 12. ) H e furt hert es t i fi edT he r ecor d cont ai ns onl yt hos e por t i ons of the tr ans cr i ptof D r . Fang’ s depos i t i on 7 te s tim o n yth a t d e f

e n d a n ts f ile d w ith th e irre n e w e d m o tio n f o r s u m m a ry ju d g m e n t. P lain tiff s d id n o t f

ile a n yo th e r p o rtio n s o f th e tra n sc rip t w ith th e D istric t C o u rt, an d d id notar gue thatanyot herpor t i on of D r . Fang’ s t es t i m onys uppor t ed thei rcas e. 10 t hat, con t raryt o p l ai nti ffs’ ar gu m ent, he d i d n ot underst and t he w arni ng s t o li m i tt hat r i sk t o pat i ent s w i t h a hi s t or yof ca r di ovas cul ardi s eas e ort hr om bot i c epi s odes , butr ead them in s te a d to s ta te th a t th e ri s k w a s p re s e n t f o r a ll p a tie n ts , “ w ith o r w ith o u t” th a t h is to ry. ( I d. at113: 8- 114: 7. ) Fi nal l y , he t es t i fi ed thathe pr es cr i bed I V I G t r eatm ent n o tw ith sta n d in g th e risk o f th ro m b o tic e v e n ts b e c a u se C o llee n h a d re sp o n d e d p o sitiv e ly t o t he tr eatm enti n t he pas tand he be l i eved the r i s ks of tr eatm entw er e outw ei ghed byt he b e n e f its . (I d . a t 5 3 :1 -5 4 :1 8 , 5 5 :2 1 -5 6 :1 1 , 1 2 5 :1 7 -1 2 6 :5 .) 7 I n s um , t her e i s no t es t i m onyfr om D r . Fang i n t he r ecor d t hatt he w arni ngs ati s s ue w e re in a d e q u a te in a n yw a y , an d th e o n lyre a so n a b le in f e re n c e f ro m h is te stim o n yis to t he contr ary . Pl ai nt i ffs came forw ar d w i t h no evi dence t hatm i ghthave unde r m i ned that t es t i m ony , and i tr ai s es no i s s ue r egar di ng D r . Fang’ s cr edi bi l i t yon i t s fac e. See W a sk o v ich v . M o rg a n o , 2 F .3 d 1 2 9 2 , 1 2 9 6 (3 d C ir. 1 9 9 3 ) (f a c ts te stif

ied to in

“‘ depos i t i on t es t i m ony. . . i f ther e i s no contr adi ct or yevi dence . . . m aybe ac cept ed as t rue fors um m aryj udgm entpurpos es w i t houtan as s es s m entof the cr edi bi l i t yof the w i t nes s ’ ”) ( ci t at i on om i t t ed) . W e agr ee that , i n l i ghtof D r . Fang’ s t es t i m ony , and plai nti ffs’ fai l ure t o p res ent anyotherevidence regardi ng t he ad equ acyof the w arni ng s, d e f e n d a n ts w e re e n tit led to su m m a ryju d g m e n t. Pl ai nt i ffs r ai s e thr ee a r gum ent s on appea l . Fi r s t , pl ai nt i ffs as s er tt hatD r . FangFort hatr eas on, defe ndant s ’ m ot i on t o s t r i ke por t i ons of pl ai nt i ffs ’ appel l at e appe ndi x, 8 i ncl udi ng D r . Fang’ s offi ce not e and otherdocument s pr es ent ed fort he fi r s tt i m e on appea l , i s gr ant ed. Pl ai nt i ffs ’ m ot i on t o expand the r ecor d on appea l i s deni ed. 11 i ni t i al l ybel i eved thatC ol l een’ s adver s e r eac t i on w as caus ed bya ki dneys t one. T hey fur t heras s er tt hatC ol l een then pr es ent ed hi m w i t h an FD A w arni ng r egar di ng t he l i nk betw een I V I G and “c l ot - r el at ed pr obl ems, ” and thatD r . Fang s ai d t he i nform at i on w as “veryi nt er es t i ng” and thathe pr evi ous l yhad notbeen a w ar e of i t . O n appea l , pl ai nt i ffs have pr es ent ed D r . Fang’ s J ul y17, 2002 not e of the off i ce vi s i tm emori al i zi ng t hat ex ch an g e. P lai n ti ff

s also p u rpo rtto q u o te i n their rep lyb ri ef fro m a p o rt ion o f D r. F an g ’s dep osi t i on , atw hich he ap parent l yackn ow l edg ed the con t ents of thatno t e. P l ai nti ffs, how ever , s ubm i t t ed nei t herD r . Fang’ s offi ce not e nort hatpor t i on of hi s depos i t i on t o t he D istri ct C o u rt . P lai n ti ff s n ev erthe less arg u e tha t D r. F an g ’s no te an d o ther d o cu m en ts are par tof the r ecor d, appar ent l ybeca us e theyw er e pr oduced dur i ng di s coveryorm arked as exhi bi t s atdepos i t i ons . B eca us e none of t he part i es fi l ed thes e document s w i t h t he D i s t r i ctC our t , how ever , t heyar e noti ncl uded i n t he r ecor d on appea l . See Fed. R . A pp. P . 1 0 (a). T h u s, w e m ayn o t con side r th em . S ee , e.g., F asse tt , 8 0 7 F . 2 d at 11 6 5 . In 8 addi t i on, pl ai nt i ffs di d notr ai s e thes e ar gum ent s i n t he D i s t r i ctC our t , s o t heyar e w ai ved o n ap p ea l. S ee In re S ton e & W eb ster, Inc . , 5 5 8 F . 3 d 2 3 4 , 2 4 1 n . 8 (3d C ir . 2 0 0 9 ). Second, pl ai nt i ffs r el yon M cN ei l v. W y eth, 462 F. 3d 364 ( 5t h C i r . 2007) , i n w hi ch t he courtr ever s ed the entr yof s um m aryj udgm entaft era di s t r i ctcour tfound a pharm ace ut i cal w arni ng l abel adequa t e as a mat t erof l aw . I n t hatcas e, how ever , t he12

t r eat i ng phy s i ci an gave confl i ct i ng t es t i m onyaboutw hetherhe w oul d have pr es cr i bed the drug ati s s ue i f the pharm ace ut i cal defe ndanthad gi ven hi m t he w arni ngs t hatt he pl ai nt i ff cl ai m ed i ts houl d have gi ven. See i d. at372. T he r ecor d cont ai ns no s uch conf l i ct i ng t es t i m onybyD r . Fang her e. T he l egal cont exti s al s o di s t i nct . I n M cN ei l , t he pl ai nt i ff pr es ent ed s ubs t ant i al evi dence on t he i s s ue of w hethert he w arni ngs w er e ade quat e, and t he tr eat i ng phy s i ci an’ s t es t i m onydi d notr el at e t o t hati s s ue. I ns t ead, i tr el at ed t o t he iss u e o f c a u sa tio n — i.e., w h e th e r th e p h y sic ian w o u ld h a v e p re sc rib e d th e m e d ica tio n if he had be en gi ven an a dequat e w arni ng. I n t hi s cas e, t he D i s t r i ctC our tdi d notr eac h t hat i s s ue, and w e nee d notdo s o, beca us e pl ai nt i ffs fai l ed t o pr es ents uffi ci entevi dence t hat t he w arni ng w as i nadequa t e i n t he fi r s tpl ace . F in a lly , p lain tiff

s d e v o te m u c h o f

th e ir b rie f

s to a rg u in g th a t D r. F a n g ’s d e c isio n to p re sc rib e IV IG tre a tm e n t w a s u n re a so n a b le. D r. F a n g , h o w e v e r, w a s d ism iss e d a s a p a rty befor e thi s s ui tw as r emoved t o fede r al cour tand thatdi s m i s s al i s notbefor e us for r evi ew . T hos e ar gum ent s ar e notr el evantt o anyi s s ue on appe al , and w e expr es s no o p i n i o n o n t h e m. A ccor di ngl y , t he j udgm entof the D i s t r i ctC our tw i l l be af fi r m ed.