NOT P RE CE DE NT I AL UN I TED STATES CO UR T OF A PP EALS F O R T H E T H IR D C IR C U IT N os . 09- 1426, 09- 3598 and 09- 4120

M . G. b ya n d th ro u g h h e r p a re n ts a n d n a tu ra l g u a rd ia n s ,

K . a n d J .G ., A ppel l ant/ C r os s A ppel l ee i n 09- 1426 and 09- 3598 v. A. I . DUP ONT HOS P I T AL F OR CH I L DR E N; NE M OUR S F OUNDA T I ON; N E M O U R S C A R D IA C C E N T E R ; W IL L IA M I. N O R W O O D ,M .D .,P H .D ; N U M E D ,IN C .; A L L E N J. T O W E R ; N E M O U R S D E IN S T IT U T IO N A L R E V IE W B O A R D ; J OHN MURP HY A ppel l ant s / C r os s A ppel l ees i n 09- 4120 A p p ea ls from the U n it ed S tat es D istri ct C o u rt f o r th e E a ste rn D istric t o f P e n n sy lv a n ia ( D . C . C i vi l N o. 2: 08- cv- 00228) D i s tr i ctJ udge: H onor abl e R . B ar cl aySur r i ck

A r gued J ul y12, 2010 B efore: R E N D E L L , JO R D A N and G R E E N A W A Y , JR . , C i rcui tJudg es. ( Fi l ed: A ugus t24, 2010) B a rb a ra R . A x e lr o d , E s q . [ ARGUE D] J ames E. B eas l ey , J r . , E s q. C ather i ne A . R othenber ger , E s q. T h e B ea sleyF irm 1125 W al nutSt r eet Phi l adel phi a, PA 191072

C ouns el f orAppel lant

/ C r os s -Appel l ee D a v id J . C re a g a n , E s q . [ ARGUE D] D avi d E . E dw ar ds , E s q. W h i t e & W i l l i a ms 1650 M arketSt r eet O ne Li bertyPl ace , Sui t e 1800 Phi l adel phi a, PA 19103 C o u n se l fo r Ap

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e m o u rs Fo u n da tio n In c ., N e m o u rs C a r d ia c C e n te r, W illia m I. N

o r w o o d , N u m e d In c ., A l l en J. Tow ers , N

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ns t i t ut i onalR evi ew B oar d and John Mur

phy R . N i chol as G i m bel , E s q. M cC art er & E ng l i sh 1735 M arketSt r eet , Sui t e 700 Phi l adel phi a, PA 19103 S a ra L . P e tr o s k y , E s q . [ ARGUE D] Suzanne Pr i t char d, E s q. M cC ann & G es chke 1 8 0 0 Jo h n F . K en n ed yB o u leva rd Sui t e 801 Phi l adel phi a, PA 19103 C o u n s e l fo rAp

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p o n t Ho s p ita l fo rC h ildr e n , N e m o u rs Fo u n da tio n In c ., N e m o u rs C a r d ia c C e n te r, W illia m I. N

o rw o o d , N um ed I nc. , A l l en J. Tow ers , N

em ours D e I

ns t i t ut i onalR evi ew B oar d and John Mur

phy J ohn M . H udgi ns , I V , E s q. W ei nber g, W heel er , H udgi ns , G unn & D i al 950 E as tPaces FerryR oad A t l ant a, G A 20236 C hr i s t opherE . A ppel , E s q. M ark A . B ehr ens , E s q. Shook, H ar dy& B acon 1 1 5 5 F . S tr e e t , N . W. Sui t e 2003

W as hi ngt on, D C 20004 C ouns el f orA m i cus Appel l ees A m er i can C oat i ngs A s s n, A m er i can I ns . A s s n. A m e r ic a n P e tr o In s titu te , A m e r ic a n T o r t R e fo r m A s s n ., A m er i can C hem is tr

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orLi t igat i on Jus t i ce, I

nc. N F IB Sm all B usi ness Leg al C enter, N at' lA ssoci ati on of M

an ufacturers, P h a r m a c e u tic a l R e s e a r c h a n d Ma n u fa c tu r e rs , P r o du c t L ia b ility A dv is o r y C o u n c il, P r o

p e r ty C a s u a lty In s u r e rs A s s n . of A m er i ca, and U

ni t ed Stat es C ham berof C om m er ce J ames M . B eck, E s q. D ec h ert 2 9 2 9 A rc h S tre e t 1 8 F loo r, C ir a C en tr e th Phi l adel phi a PA 19104 C ouns el f orA m i cus Appel l ee P ro du c t L ia b ili ty A dv iso ry C o u n c il OPI NI ON O F THE COURT R E N D E L L , C i r cui tJ udge. M . G . ( “Pl ai nt i ff” ) appea l s the D i s tr i ctC our t ’ s gr antof s um m aryj udgm enton her cl ai m of negl i gence i n favorof def endant s A . I . duPontH os pi t al forC hi l dr en, the N emours Foundat i on, the N emours C ar di ac Cent er , N emours D el aw ar e I ns t i tut i onal R evi ew B oar d ( col l ect i vel y , the “I ns t i tut i onal D efe ndant s ”) ; D r . W i l l i am N orw ood and D r . J ohn M urphy( the “M edi cal D efe ndant s ”) ; and N uM ed, I nc. T he I ns t i tut i onal D efe ndant s , M edi cal D efe ndant s , and N uM ed ( col l ect i vel y , “D efe ndant s ”) , cr os s appea l the D i s tr i ctC our t ’ s deni al of s um m aryj udgementon Pl ai nt i ff’ s m edi cal m oni t or i ng claim . F o r th e f

o ll o w ing rea so n s w e w il l aff irm the D istri ct C o u rt ’s gra n t of su m m aryIn itia lly, th e p a re n ts o f th re e c h ild re n , in c lu d in g P la in tif f , b ro u g h t a c la s s a c tio n . 1 In A p ril 2 0 0 7 , the p a rties stip u late d to c o n v e rt th e a c tio n f ro m a c las s a c tio n to se p a ra te c iv il a c tio n s . O n ly P la in tif f’s c a s e is b e f

o re u s . 4 jud g m en t as t o the n eg li g en ce claim an d rev erse the D istri ct C o u rt ’s de n ial o f su m m ary j u d g me n ta s t o th e me d i c a l mo n i t o r i n g c l a i m. 1 I. P lain tiff w a s b o rn w ith D o w n S yn d ro m e a n d a c o m b in a tio n o f th re e h e a rt d e f

e c ts thatar e uncomm on butw el l - know n congeni t al car di ac mal form at i ons thatacc om pany D o w n S yn d rom e. A s a re su lto f h er c o n d it ion , P lai n ti ff u n d erw en t trea tm en t atthe A . I. d u P o n t H o sp ital f

o r C h ild re n in W ilm in g to n , D e law a re , w h e re it w a s d e ter m in e d th a t a s hunt i ng pr ocedur e know n as the Font an pr ocedur e w as the mostappr opr i at e tr eatm ent f o r P lain tiff ’s c o n d iti o n . T h e F o n tan p ro c e d u re m o d if ies th e p h y sio lo g yo f

th e h e a rt to d e a l w ith th e p rim a rye f f e c t o f P lain tiff ’s h e a rt d e f

e c ts— th e in a b ili tyo f

h e r h e a rt to a d e q u a telyp u m p b lo o d to h e r lu n g s to b e o x y g e n a ted . A F o n tan p h y sio lo g yis typ ica lly cr eat ed i n a tw o- s t ep pr oces s , a H emi - Font an fol l ow ed bya s ur gi cal Font an C om pl et i on, e a c h o f w h ich tra d iti o n a llyre q u ire s o p e n h e a rt su rg e ry . H e re , the M e d ica l D e f e n d a n ts achi eved the Font an C om pl et i on notthr ough s ur gery , butthr ough a r el at i vel ynew cather i zat i on pr ocedur e ( “C ather i zat i on Font an”) thati ncl uded the i m pl ant at i on of a C heatham P l at i num St ent( “C P St ent ”) . T he C P St enthad notbeen appr oved bythe Food and D rug A dm i ni s tr at i on, a fa ctunknow n t o Pl ai nt i ff’ s par ent s atthe t i m e of the p ro c e d u re .5

F o l l o w i n g i m p l a n t a t i o n o f th e C P S t e n ta n d th e c r e a t i o n o f th e F o n t a n p h ys i o l o g y, P lain tiff b e g a n to d e v e lo p p ro tein lo sin g e n ter o p a th y(“ P L E ” ) a n d p las tic b ro n c h iti s ( “ P B” ) . P L E a n d P B a r e r a r e a n d l i f e - th r e a t e n i n g c o n d i t i o n s , b u ta r e k n o wn compl i cat i ons of a Font an phy s i ol ogy . A l though i ni t i al l yunderthe ca r e of the M edi cal a n d I n s t i tu t i o n a l De f

e n d a n t s f o rtr e a tme n to f

h e rP LE a n d P B, P l a i n t i f f’ s p a r e n t s b e c a me d issati sfied w ith the c are P lai n ti ff w as re ce iving , an d tr an sfe rred h er to the C h il d ren ’s H os pi t al of Penns y l vani a ( “C H O P”) . W hi l e Pl ai nt i ff’ s PL E di s s i pat ed, herPB r emai ned per s i s t ent , l eadi ng Pl ai nt i ff’ s phy s i ci ans atC H O P t o concl ude thatthe bes tcour s e of tr e a tmentw ou l d b e t o f e ne s tr a t e , orpu ta ho l e i n, the CP St e nt . Eve ntua l l y , Pl a i nt i ff’ s PB nece s s i t at ed mul t i pl e fe nes tr at i on pr ocedur es and the i m pl ant at i on of tw o addi t i onal s t ent s . Pl ai nt i ff’ s phy s i ol ogi cal condi t i on, under l y i ng devel opm ent al i s s ues , and cont i nui ng s truggl e w i th PB , nece s s i t at e ongoi ng m edi cal car e and s urvei l l ance . Pl ai nt i ff’ s or i gi nal compl ai ntcont ai ned s i x di s t i nctcount s : ( I ) N egl i gence : L ack of I n f o rm e d C o n s e n t , ( I I ) F r a u d a n d I n t e n t i o n a l M i s r e p r e s e n t a t i o n , ( I I I ) A s s a u l ta n d B a t t e ry, (IV ) S tr ictP rod u cts L iabili ty , (V ) B rea ch o f E x p ress a n d Im p li ed W arran ti es, an d (V I) M e d i c a l M o n i t o r i n g . P l a i n t i f f’ s c o mp l a i n ta s s e r t s th a th e r“ e x p o s u r e t o th e Nu M ED CP St entand I m pl ant at i on Pr ocedur e . . . caus ed and w i l l cont i nue t o caus e [he r ] t o s uffe r phy s i cal pai n, m ent al angui s h, m edi cal and otherr el at ed per s onal i nj ur i es and/ or expens es . ” A pp. 149. Speci fi cal l y , Pl ai nt i ff c ont ended that“as a di r ectr es ul tof the s t ent pl ace m entand i t s r es ul t i ng phy s i ol ogi c ef fec t s ” s he deve l oped “a tl eas ttw o s er i ousT he D i s tr i ctC our tconduct ed a c hoi ce of l aw anal y s i s thati s uncont es t ed on 2 a p p e a l. T h e D istric t C o u rt f o u n d D e law a re law a p p lica b le b e c a u se , alth o u g h P lain tiff is fr om N ew J er s eyand Penns y l vani a i s the forum s t at e, the compl ai ned- of conduc t o c c u rre d in D e law a re , P lain tiff in ten tio n a llytra v e led to D e law a re to re c e iv e tre a tm e n t, and D el aw ar e has an i nt er es ti n r egul at i ng act i vi tyw i thi n i t s bor der s and mai nt ai ni ng the predi ct abil i tyof it s heal th care regul at i on s. 6 m edi cal condi t i ons . . . Pr ot ei n L os i ng E nt er opathy( PL E ) and pl as t i c br onchi t i s [PB ] . ” A p p . 1 5 8 . II. O n February6, 2009, the D i s tr i ctC our ti s s ued tw o m emora nda and a ccompany i ng o rd e rs, o n e re so lv in g th e c laim s a g a in st th e M e d ica l an d In stitu tio n a l D e f e n d a n ts ( her ei naft er , “Fi r s tM emora ndum ”) , the otherr es ol vi ng the cl ai m s agai ns tN uM E D , I nc. a n d its C E O A lle n T o w e r ( h e re in a f te r, “ S e c o n d M e m o ra n d u m ” ). A . Fi r s tM emora ndum I n the Fi r s tM emora ndum , the D i s tr i ctC our tappl i ed D el aw ar e l aw and not ed that 2 the D elaw are H ea lth C are M alpra cti ce Insu ran ce an d L it igation A ct (th e “ H ea lth C are A ct ”) , 18 D el . C . §§ 6801 et s eq . , governed the cl ai m s ati s s ue, s i nce i tdefi nes m edi cal negl i gence i n an al l - encompas s i ng m anneras “anyt or torbr eac h of contr actbas ed on h e a l th c a r e o rp r o f

e s s i o n a l s e rv i c e s r e n d e r e d , o rw h i c h s h o u l d h a v e b e e n r e n d e r e d , b y a heal th car e pr ovi dert o a pat i ent . ” A pp. 23 ( ci t i ng 18 D el . C . § 6801( 7) ) . T he D i s tr i ct C o u rt c o n tin u e d :

A corner s t one of the H eal th C ar e A cti s the r equi r ementthat plai nti ffs assert i ng cl ai m s agai nsthealthcare providers m ustTh e Di s tr i c tCo u r th a d p r e v i o u s l yd i s mi s s e d P l a i n t i f f’ s a s s a u l ta n d b a t t e ryc l a i m, 3 str ictli ab il ityclaim , an d b rea ch o f e x p ress a n d im p li ed w arran ti es c lai m ag ains t D r. N o rw o o d a n d D r. M u rp h y , an d e x ten d e d th a t co n c lu sio n to th e In stitu tio n a l D e f e n d a n ts in thi s deci s i on. Pl ai nt i ff doe s notaddr es s thi s i s s ue orthes e cl ai m s i n heropeni ng br i ef, a n d s o th e s e c la im s h a v e b e e n w a iv e d . 7

s uppor tthos e cl ai m s w i th expertt es t i m onyr egar di ng the heal thcar e pr ovi der ’ s devi at i on fr om the s t andar d of ca r e and the c au sal co n n ec ti o n b etw ee n the h ea lth ca re p rov ider’s d e v ia tio n a n d p la in tif

f’s in ju ry. See 18 D el . C . § 6853( e) (“N o li abil i tyshal l be b ased up on assert ed n egli gen ce un l ess expertm edi cal t es t i m onyi s pr es ent ed as t o the al l eged d e v iatio n f

ro m th e a p p lica b le s tan d a rd o f c a re in th e sp e c if

ic ci r cumst ance s of the ca s e and a s t o the ca us at i on of the al l eged pe r s onal i nj uryordeath . . . . ”) . I ndeed, the t es t i m ony of a c om pet entm edi cal experti s an es s ent i al el ementof any m edical neg l i gen ce cl ai m , i ncludi ng i nfo rm ed co nsent cl ai m s, i n D el aw ar e. A pp. 24. T he D i s tr i ctC our tfound thatPl ai nt i ff’ s m edi cal negl i gence , l ack of i nform ed cons ent , and fr aud cl ai m s al l fai l ed bec aus e Pl ai nt i ff di d nots at i s fyherbur den of pr oduci ng m edi cal expertt es t i m onythates t abl i s hed ca us at i on. A ccor di ngl y , the D i s tr i ct 3 C o u rtg ra n te d th e m o tio n s f o r s u m m a ry ju d g m e n t w ith re s p e c t to th e s e c la im s . T he D i s tr i ctC our tal l ow ed Pl ai nt i ff’ s “M edi cal M oni t or i ng” cl ai m t o pr ocee d, d en y ing the m o ti o n fo r sum m aryjud g m en t w ith resp ec t t o this co u n t. T h e D istri ct C o u rt acknow l edged that , al though Penns y l vani a and N ew J er s eyr ecogni ze medi cal m oni t or i ng as a ca us e of a ct i on, i n D el aw ar e, “i ti s notcl earw hetherm edi cal m oni t or i ng i s an i ndepende ntt or torw hetherm edi cal m oni t or i ng i s s i m pl ya r emedy , as i ti s i n m anyother j ur i s di ct i ons . ” A pp. 22. T he D i s tr i ctC our tnot ed thatthe “D el aw ar e Supr eme C our thasT he D i s tr i ctC our tdi s m i s s ed Pl ai nt i ff’ s s tr i ctl i abi l i tycl ai m on the gr ounds that 4 D el aw ar e l aw bar s s tr i ctpr oductl i abi l i tycl ai m s , and the br eac h of expr es s and i m pl i ed w a rr a n tie s c la im s f

a ile d f o r a v a ri e ty o f

n o n -c a u s a tio n re la te d re a s o n s . 8 acknow l edged medi cal m oni t or i ng buthas neverexpl i ci t l yr ecogni zed medi cal m oni t or i ng as a l egal l ycogni zabl e ca us e of a ct i on, ” and that , as a r es ul t , the D i s tr i ct C our ts i t t i ng i n di ver s i ty“mustpr edi cthow the s t at e’ s s upr eme courtw oul d r es ol ve the i s s ue, gi vi ng cons i der at i on t o the dec i s i ons of i nt erm edi at e s t at e court s . ” A pp. 39. T he D i s tr i ctC our tthen pr edi ct ed thatthe D el aw ar e Supr eme C our tw oul d perm i ta cl ai m for m e d ica l m o n ito rin g o n th is re c o rd . T h e D istric t C o u rt su g g e ste d th a t b e c a u se D e f e n d a n ts caus ed Pl ai nt i ff t o come i nt o cont actw i th an adul t er at ed medi cal devi ce a nd thi s cont act (a n d th e c o n tin u e d p re se n c e o f th e d e v ice in P lain tiff ’s b o d y ) w ill re q u ire P lain tiff to r e c e i v e c o n t i n u e d me d i c a l mo n i t o r i n g s p e c i f i c a l l ywi th r e s p e c tt o th e e f f e c t s o f th e CP S te n t, P la in tif

f m ig h t b e a b le to s u s ta in a m e d ic a l m o n ito ri n g c la im .

B. S e c o n d M e mo r a n d u m I n the Second M emora ndum , w hi ch dea l tw i th the cl ai m s agai ns tN uM E D , I nc. ( the manufactur erof the C P St ent ) , and A l l en Tow er( the s ol e s har ehol derand C E O of N u M E D , In c .), th e D istric t C o u rt a g a in f o u n d th a t D e law a re law a p p lied w ith re sp e c t to the v ariou s tort cl aim s in C o u n ts I thro u g h V , an d that, ag ain, P lai n ti ff ’s claim s w ere bl ocked due t o heri nabi l i tyt o demonstr at e ca us at i on. Pl ai nt i ff doe s notar gue for 4
r e v e r s a l o f

s u mma ryj u d g me n to n a n yo f th e s e f i v e c o u n t s wi th r e s p e c tt o e i th e rNuM ED orT ow er , i ncl udi ng the l ack of i nform ed cons entcl ai m , and s o thes e i s s ues have be en9

w a iv e d . T h e Di s tr i c tCo u r td e n i e d Nu M E D’ s mo t i o n f o rs u mm a ryj u d g me n ta s t o Co u n tVI (th e m e d ica l m o n ito rin g c laim ) w ith re sp e c t to N u M E D , fo r th e sa m e re a so n s th a t it d en ied th e m o ti o n fo r sum m aryjud g m en t i n the o ther d ec isi o n . T h e D istri ct C o u rt gr ant ed the mot i on fors um m aryj udgm entw i th r es pectt o A l l en Tow er , on the gr ounds th a t, ap p ly in g N e w Y o rk law (th ro u g h a n e w c h o ice o f law a n a ly sis ), P lain tiff f a iled to pr ove “c om pl et e domi nat i on” and t o pi er ce the corpor at e vei l . A gai n, Pl ai nt i ff doe s not ar gue forr ever s al of the entryof j udgm enti n favorof A l l en Tow eri n heropeni ng br i ef, a n d s o th a t is s u e is w a iv e d . C . R emai ni ng I s s ues on A ppeal A l though Pl ai nt i ff’ s N ot i ce of A ppeal i ndi cat ed thats he w as appea l i ng the di s m i s s al of C ount s I thr ough V , the onl yone of thes e fi ve count s s he addr es s ed i n her O p e n in g B rie f

is h e r n e g lig e n c e -b a se d lac k o f in f o rm e d c o n se n t cla im se t f o rth in C o u n t I o f h e r C o m p la in t a g a in s t th e M e d ic a l D e f e n d a n ts a n d th e In s titu tio n a l D e f e n d a n ts . A c c o rd in g ly, th e o th e r i s s u e s h a v e b e e n w a iv e d . See Tr aci nda C or p. v. D ai m l er C hr

ys l er AG , 502 F. 3d 212, 236 n. 18 ( 3d C i r . 2007) ( “[I ] ti s w el l - s ett l ed i n thi s courtthatan appel l ant ’ s fai l ur e t o i dent i fyorar gue an i s s ue i n hi s openi ng br i ef c ons t i tut es w ai verof th a t issu e o n a p p e a l.” (in ter n a l q u o tatio n m a rk s a n d c itatio n s o m itt e d )); U ni t ed Stat es v. P e lu llo , 39 9 F . 3d 19 7, 20 1 n . 2 (3d C i r. 20 05 ) ( “W here, as here, an ap pell ant fai l s t o rai se an i s s ue i n an appe l l at e br i ef, even i f i tw as l i s t ed i n the N ot i ce of A ppeal , i ti s deemed10

w a iv e d .” ), cer tdeni ed , 5 4 6 U .S . 1 1 3 7 (2 0 0 6 ). N uM E D , the M edi cal D efe ndant s , and the I ns t i tut i onal D efe ndant s al l cr os s appea l th e d e n ia l o f

s u m m a ry ju d g m e n t o n th e m e d ic a l m o n ito ri n g c la im . III . T he D i s tr i ctC our thad j ur i s di ct i on pur s uantt o 28 U . S. C . § 1332. W e have j ur i s di ct i on overPl ai nt i ff’ s appea l pur s uantt o 28 U . S. C . § 1291, and overthe D efe ndant s ’ cr os s - appea l pur s uantt o 28 U . S. C . § 1292( b) . W e exe r ci s e pl enaryr evi ew overa gr antordeni al of s um m aryj udgementand appl ythe s ame st andar d us ed bythe D is tr ic t C o u rt . G i l es v. Kearney , 5 7 1 F . 3 d 3 1 8 , 3 2 2 (3d C ir . 2 0 0 9 ). A g ran t of su m m ary j udgm ent“s houl d be r ender ed i f the pl eadi ngs , the di s coveryand di s cl os ur e mat er i al s on fi l e, and anyaff

i davi t s s how thatther e i s no genui ne i s s ue as t o anym at er i al fac tand that the movanti s ent i t l ed t o j udgm entas a mat t erof l aw . ” Fed. R . C i v. P. 56( c) . W e vi ew th e f a c ts in th e lig h t m o st f

a v o ra b le to th e n o n m o v in g p a rty , d ra w in g a ll rea so n a b le i nfer ence s i n the non- m ovant ’ s favor . H ow ever , “[t ] he mer e exi s t ence of a s ci nt i l l a of evi dence i n s uppor tof the pl ai nt i ff’ s pos i t i on w i l l be i ns uffi ci ent ; ther e mustbe evi dence on w hi ch the j urycoul d r eas onabl el yfi nd forthe pl ai nt i ff. ” A nders on v. Li ber t y Lobby, In c ., 4 7 7 U .S . 2 4 2 , 2 5 2 (1 9 8 6 ). A . N egl i gence : L ack of I nform ed C ons ent A s the D istri ct C o u rtn o ted, m ed ical ne g li g en ce ac ti o n s b rou g h t un d er D elaw are l aw ar e governed bythe H eal th C ar e A ct . T he H eal th C ar e A ctdefi nes m edi cal11

negl i gence as “anyt or torbr eac h of contr actbas ed on hea l th car e orpr ofes s i onal s ervi ces r ender ed, orw hi ch s houl d have be en r ender ed, bya hea l th car e pr ovi dert o a pat i ent . ” 18 D el . C . § 6801( 7) . U nders ect i on 6853, t i t l ed “A ffi davi tof M er i t , expertm edi cal t est i m on y , ” the H eal th C are A ctexp l i ci t l yst at es:

N o li abil i tyshal l be b ased up on assert ed n egli gen ce un l ess expertm edi cal t es t i m onyi s pr es ent ed as t o the al l eged d e v iatio n f

ro m th e a p p lica b le s tan d a rd o f c a re in th e sp e c if

ic ci r cumst ance s of the ca s e and a s t o the ca us at i on of the a lle g e d p e rs o n a l in

ju ry o r d e a th . . . 1 8 D el. C . § 6 8 5 3 (e). T h u s, u n d er the H ea lth C are A ct, a c lai m an t m u st sho w , b yex p ert m edi cal t es t i m ony , ( 1) the appl i cabl e s t andar d of ca r e, ( 2) the devi at i on fr om that stan d ard , an d (3) tha t th is de v iat ion ca u sed the a ll eg ed p erso n al i n juryo r de ath. D elaw are la w re q u ir e s th a t c a u s a tio n m e e t th e “ b u t f o r” c a u s a tio n s ta n d a rd , se e E dw a rd s v . Fa m ily P r act i ce Ass oci at es , I

nc. , 79 8 A . 2d 10 59 , 10 66 (D el . S up er. C t . 20 02 ) ( “P l ai nti ffs m ust s how s uch negl i gence w as a pr oxi m at e ca us e of i nj ury ; thati s , butforthe negl i gence , the i nj uryw oul d nothave happened. ”) , w hi ch means thatthe cl ai m antm us ts how thatthe harm w oul d nothave oc curr ed i f notforthe def endant ’ s devi at i on fr om the s t andar d of c a re . See Burkhar tv. D avi es , 6 0 2 A .2 d 5 6 , 5 9 (D e l. 1 9 9 1 ). T h e In f o rm e d C o n se n t S tatu te o f th e H e a lth C a re A c t, 18 D e l. C . § 6 8 5 2 , is co n tai n ed w ith in, and g o v ern ed b y , the “ M ed ical N eg li g en ce ” c h ap ter of the D elaw are C o d e . See Brz os ka v. O l s on , 668 A . 2d 1355, 1366 ( D el . 1995) ( “I f a he al th car e pr ovi der viol at es hi s or herdu tyof ca re i n o btai ning the co nsent of the p at i ent byfai l i ng t o d i scl ose12

al l r el evanti nform at i on ( r i s ks ) thata r eas onabl e per s on w oul d deem si gni fi canti n m aki ng a dec i s i on t o have the pr ocedur e, the ac t i on s houl d be pl eade d i n negl i gence — not batt ery . ”). T he H eal th C are A ctdefines i nfo rm ed co nsent as :

the c o n sen t of

a p ati en t t o the p erf

o rm an ce o f h ea lth ca re serv ices b ya h ea lth ca re p rov ider g iven af ter th e h ea lth ca re p ro v id e r h a s in f

o rm e d th e p a tien t, t o a n e x ten t re a so n a b ly compre hens i bl e t o gener al l ayunder s t andi ng, of the natur e of the pr opos ed pr ocedur e ortr eatm entand of the r i s ks and a ltern a tiv e s to tre a tm e n t o r d iag n o sis w h ich a re a so n a b le pat i entw oul d cons i derm at er i al t o the dec i s i on w hetherornot t o u nd ergo the tr eat m ent ordiagnosi s. 1 8 D e l. C . § 6 8 0 1 (6 ). C o n se q u e n tly , as w ith o th e r c laim s u n d e r th e H e a lth C a re A c t, t o s ucce ed on a l ack of

i nform ed cons entcl ai m s uch as thi s one, a pl ai nt i ff musts how that byfai l i ng t o obt ai n i nform ed cons ent , a def endantfel l bel ow the appl i cabl e s t andar d of car e. I n part i cul ar , the cl ai m antm us tpr ove “bya pr eponder ance of evi dence thatthe heal th car e pr ovi derdi d nots uppl yi nform at i on r egar di ng s uch tr eatm ent , pr ocedur e or s ur geryt o the ext entcus t om ar i l ygi ven t o pat i ent s , orotherper s ons author i zed t o gi ve cons entforpat i ent s byotherl i cens ed hea l th car e pr ovi der s i n the s ame ors i m i l arfi el d of m edi ci ne as the def

endant . ” 18 D el . C . § 6852( a) . T he pl ai nt i ff mustal s o s how thatthe devi at i on fr om the s t andar d of ca r e ca us ed the harm , s uppor t i ng thi s evi dent i arybur den w ith th e p re se n tatio n o f e x p e rt tes tim o n y . T h is re q u ire m e n t h a s b e e n e x p licitlya p p lied to la c k o f in f o rm e d c o n s e n t c la im s . See V alent i ne v. M

ark , 2 0 0 4 W L 2 4 1 9 1 3 1 , at * 3 (D e l. Super . C t . O ct . 20, 2004) ( “M or e i m por t ant l y , an i nform ed cons entact i on s t i l l r equi r es e x p e rt tes tim o n ya s to c a u sa tio n . . . . S e c tio n 6 8 5 3 m a k e s it a b u n d a n tlyc lea r th a t . . . o n ly13

expertt es t i m onycan pr ove the es s ent i al el ementof ca us at i on. Sect i on 6852 [the i nform ed cons entpr ovi s i on] cannotther efor e be us ed as a bac kdoorar ound the req u ir em en t th at ca u sati o n in m ed ical ne g li g en ce ca ses b e su p p o rt ed b yex p ert tes tim o n y .”). A c c o rd in g ly , in o rd e r to p re v a il o n a c a u se o f a c tio n f o r in f o rm e d c o n se n t, D el aw ar e l aw r equi r es a cl ai m antt o s how notj us ta devi at i on fr om the s t andar d of ca r e, butt o s how byexpertt es t i m onythatthe devi at i on compl ai ned of i s the “butfor ” ca us e of a le g a lly c o g n iz a b le h a rm . W e a g ree w ith the D istri ct C o u rtthat P lai n ti ff h as n o t prese n ted th e n ec essa ry expertt es t i m onyt o demonstr at e thatthe devi at i on fr om the s t andar d of ca r e bythe D efe ndant s w as the “butfor ” ca us e of the harm s he s uffe r ed. Pl ai nt i ff ha s demonstr at ed thatfol l ow i ng the C ather i zat i on Font an and the i m pl ant at i on of the C P St ent , s he s uffe r ed fr om PL E and cont i nues t o s truggl e w i th PB . H ow ever , the compl i cat i ons s uffe r ed by Pl ai nt i ff a r e know n compl i cat i ons of the Font an phy s i ol ogy , and Pl ai nt i ff di d notpr oduce exp ertm edical t est i m on yshow i ng that these ha rm s w ere caused bythe D efen dan t s’ f a ilu re to in f

o rm a s to th e u se o f

th e C P S ten t o r b yth e C a th e riz a tio n F o n tan . T h e o n ly m e d ica l ex p e rt P lain tiff p ro d u c e d , D r. P a u l G ro ss f e ld , tes tifie d th a t P L E a n d P B a re b o th know n compl i cat i ons of the Font an phy s i ol ogythatcan a nd do devel op even i n the abs ence of negl i gence bythe tr eat i ng phy s i ci an. A pp. 242- 44. I n r es pons e t o the di r ect ques t i on of w hetherPl ai nt i ff’ s compl i cat i ons w er e due t o the C P st entorthe us e of the cather i zat i on pr ocedur e, D r . G r os s fel d r epl i ed “I don’ tknow , ” and “ I don’ tknow . I thi nkP l ai nti ff u rges on ap peal that herharm i s not l i m i t ed to PL E and P B , bu tal so 5 i n c l u d e s th e h a rm o f

b e i n g r e q u i r e d “ t o u n d e r g o mu l t i p l e p r o c e d u r e s t o f e n e s tr a t e [ th e CP St ent ] , ” A ppel l ant ’ s B r . 48, and t o under go “addi t i onal pr ocedur es t o expand the s t entas sh e g ro w s” in th e f

u tu re . A p p e llan t’s R e sp . B r. 1 1 . P lain tiff c o n ten d s th a t h e r p a re n ts w oul d nothave c ons ent ed t o the C P St enti m pl ant at i on i f theyhad bee n gi ven al l of the i nform at i on. A ccor di ngl y , Pl ai nt i ff ur ges thatthe mul t i pl e fe nes tr at i on pr ocedur es s he had t o under go atC H O P, as a r es ul tof the C P St ent , and the cr eat ed nee d t o di l at e or e x p a n d th e ste n t in th e f u tu re , rep re se n t h a rm th a t b u t f o r D e f e n d a n ts’ a c tio n s (in p ro c e e d in g w ith o u t in f

o rm e d c o n s e n t) s h e w o u ld n o t h a v e to e n d u re . I n r es pons e, D efe ndant s ur ge thatthe tr eatm entPl ai nt i ff unde rw entatC H O P— the fene s tr at i on pr ocedur es — ar e a r es ul tof know n compl i cat i ons of Font an phy s i ol ogythat Pl ai nt i ff w oul d have ha d t o under go r egar dl es s of w hetherthe Font an w as compl et ed by s ur geryorcathet er . D efe ndant s ’ pos i t i on i s thati f s ur gi cal compl et i on had t aken pl ace , Pl ai nt i ff w oul d have ha d a G or e- T ex tube i m pl ant ed, w hi ch w oul d have r equi r ed Pl ai nt i ff’ s C H O P doct or s t o punch a hol e orfene s tr at e the s ame G or e- T ex mat er i al that w a s u se d f

o r th e C P S ten t. W e not e, fi r s t , thatPl ai nt i ff di d nots peci fi cal l yi dent i fythe nee d t o under go m u lti p le f

e n e stra tio n p ro c e d u re s a s a h a rm in h e r in iti a l co m p lain t. E v e n lea v in g th is co n ce rn a side , P lai n ti ff ’s arg u m en t i s u n av ail ing as sh e d o es n o t i d en ti fyan yex p ert t es t i m onyi n the r ecor d thates t abl i s hes thatD efe ndant s ’ act i ons w er e a “ butfor ” ca us e of th e n e e d f

o r m u ltip le f

e n e s tr a tio n p ro c e d u re s .

14 th a t’ s u n lik e ly,” r e s p e c tiv e ly. A p p . 2 4 3 -4 4 . T he D i s tr i ctC our t ’ s concl us i on s eems i nes capabl e. Pl ai nt i ff di d notm eether b u rd e n w ith re sp e c t to c a u sa tio n , an d su m m a ryju d g m e n t w a s a p p ro p ria telyg ra n ted w ith r e s p e c tt o th i s c l a i m. 5 B . M edi calM oni t or i ng Pl ai nt i ff’ s or i gi nal s i xth caus e of a ct i on w as a cl ai m ent i t l ed “M edi cal M oni t or i ng. ” She cont ended that“[a ] s a di r ectr es ul tof def endant s ’ act s , om i s s i ons , and conduct , pl ai nt i ffs . . . w ho have r ece i ved N uM E D C P st enthave be en expos ed t o a15

haza r dous pr ocedur e and pr oduct , and s uffe r ed a s i gni fi cant l yi ncr eas ed r i s k of the s i de eff ect s caus ed bythi s devi ce. T hi s i ncr eas ed r i s k m akes per i odi c di agnos t i c and medi cal exami nat i ons r eas onabl e and ne ces s ary . ” A pp. 178. T he compl ai ntcont i nued:

“ M e d i c a l mon i t o r i n g i s n e c e s s a ryb e c a u s e : ( a ) Th e NuM ED C P St enti s a pr oven and a dm i t t edl yhaza r dous pr oduct ; ( b) P lai n ti ff s’ ex p o su re to the h az ard o u s p rod u ct an d p roc ed u re w as pr oxi m at el ycaus ed bydefe ndant s ’ t or t i ous conduct ; ( c) M e d i c a l mo n i t o r i n g wi l l d e t e c ti n j u r i e s f r o m th e Nu M ED CP St entand i t s i m pl ant at i on; ( d) T hi s m oni t or i ng w i l l be d if f e re n t f ro m w h a t n o rm a llyis re c o m m e n d e d to in d iv id u a ls w ho di d notr ece i ve a N uM E D C P St ent ; and ( e) M edi cal m oni t or i ng w i l l as s i s ti n pr event i ng furtheri nj ur i es fr om oras a cons equenc e of i m pl ant at i on of the N uM E D C P St ent . ” A pp. 178- 79. Pl ai nt i ff pos ed the medi cal m oni t or i ng cl ai m as an i ndepende ntcaus e of a c tio n , n o t m e re lya s a re m e d yf o r n e g lig e n c e o r so m e o th e r to rtio u s c o n d u c t, de sp ite condi t i on ( b) , w hi ch r efe r s t o “def endant s ’ t or t i ous conduct . ” A s n o ted a b o v e , the D istric t C o u rt a llo w e d P lain tiff ’s “ M e d ica l M o n ito rin g ” c laim t o pr ocee d, deny i ng the mot i on fors um m aryj udgm entw i th r es pectt o thatcount . T he D i s tr i ctC our tacknow l edged thati n D el aw ar e, “i ti s notcl earw hetherm edi cal m o n ito rin g is a n in d e p e n d e n t to rt o r w h e th e r m e d ica l m o n ito rin g is s im p lya re m e d y , as it is i n m an yo ther jurisdicti o n s. ” A p p . 2 2 . T h e D istri ct C o u rtn o ted th at th e “ D elaw are Supr eme C our thas acknow l edged medi cal m oni t or i ng buthas neverexpl i ci t l yr ecogni zed m edi cal m oni t or i ng as a l egal l ycogni zabl e ca us e of a ct i on, ” and that , as a r es ul t , the D istric t C o u rt sitting in d iv e rsity“ m u st p re d ict h o w th e sta te’ s s u p re m e c o u rt w o u ld r es ol ve the i s s ue, gi vi ng cons i der at i on t o the dec i s i ons of i nt erm edi at e s t at e court s . ” A pp.16

3 9 . T h e D istric t C o u rt th e n p re d icte d th a t th e D e law a re S u p re m e C o u rt w o u ld p e rm it a c la im f o r m e d ic a l m o n ito ri n g o n th is re c o rd . I n an A ugus t28, 2009 O r der , the D i s tr i ctC our tcert i fi ed the fol l ow i ng thr ee i s s ues f o r im m e d iate in ter lo c u to rya p p e a l to th is C o u rt: 1) W oul d the D el aw ar e Supr eme C our tr ecogni ze am edi cal m oni t or i ng caus e of act i on i f pr es ent ed w i th the r ecor d i n thi s cas e? 2) I f the appe l l at e courtans w er s the fi r s tcert i fi ed ques t i on i n the af fi rm at i ve, w oul d Pl ai nt i ff be abl e t o s t at e a c l ai m form edi cal m oni t or i ng i n D el aw ar e? 3) I f the appe l l at e courtans w er s the fi r s ttw o cert i fi ed ques t i ons i n the af fi rm at i ve, w oul d Pl ai nt i ff meethers um m aryj udgm entbur den of e s t abl i s hi ng a genui ne i s s ue o f f a c tf o rtr i a l r e g a r d i n g h e rme d i c a l mon i t o r i n g c l a i m? A p p . 9 9 -1 0 0 . B e c a u se w e f

in d th a t P lain tiff

is u n a b le to e sta b lish th e e lem e n ts n e c e ss a ryto sta te a cl ai m form edi cal m oni t or i ng, w e dec l i ne t o r eac h the ques t i ons pos ed bythe D i s tr i ct C o u rt, an d w ill , fo r th e f o llo w in g re a so n s, re v e rse th e d e n ial o f su m m a ryju d g e m e n t. D ef en d an ts argu e tha t th e D istri ct C o u rterred in p red ict ing that the D elaw are S u p rem e C o u rtw o u ld ad o p t a st an d -alon e c au se o f a cti o n fo r m ed ical m o n it o ri n g . In part i cul ar , D efe ndant s cont end thatthe D i s tr i ctC our terr ed i n ext endi ng D el aw ar e l aw bey ond the bounds of the r ecogni zed medi cal m oni t or i ng cl ai m i n w hi ch a pl ai nt i ff al l eges l ong- t erm expos ur e t o a pr oven t oxi c s ubs t ance w i th know n t endenc i es t o pr oduce s e ri o u s f u tu re m e d ic a l in

ju ri e s . W e a g re e . N ei therthe D i s tr i ctC our tnorPl ai nt i ff poi nt s t o anycas e i n thi s C i r cui t , l etal oneT he D el aw ar e Supr eme C our thas notr ecogni zed acaus e of a ct i on form edi cal 6 m o n ito rin g , a f

a c t th e D istric t C o u rt a c k n o w led g e d . T h e D istric t C o u rt n o tes th a t co u rts in D e law a re h a v e “ a c k n o w led g e d ” m e d ica l m o n ito rin g tac itl yw ith o u t “e x p re ss ly addr es s i ng i t s vi abi l i tyas a ca us e of a ct i on. ” A pp. 39 n. 8 ( ci t i ng A lderm an v. C l ean E ar th, I nc. , N o. 04C - 06- 181, 2007 D el . Super . L E X I S 191, at*8 ( D el . Super . C t . J une 26, 2 0 0 7 ); B r

z os ka v. O l

s en , N o . 9 2 C -0 6 -1 4 2 , 1 9 9 4 D e l. S u p e r. L E X IS 2 3 0 , at * 9 (D e l. S u p e r. C t. M a y2 , 1 9 9 4 ), af f’ d i n par t

, r ev’ d on othergr ounds , 6 6 8 A .2 d 1 3 5 5 (D e l. 1 9 9 5 ); In re A sb e sto s L iti g ., N o . 8 7 C -0 9 -2 4 , 1 1 9 9 4 D e l. S u p e r. L E X IS 6 8 5 , at * 5 (D e l. S u p er. C t. A u g . 5 , 1 9 9 4 )). 17 in D e law a re , in w h ich a f re e -sta n d in g m e d ica l m o n ito rin g c laim h a s b e e n a llo w e d to p ro c e e d a lth o u g h th e p lain tiff h a s n o t d e m o n stra ted sig n if ica n t ex p o su re to a to x ic (p o iso n o u s) o r p ro v e n h a z a rd o u s s u b sta n c e . M e d ica l m o n ito rin g w a s a d d re ss e d b yth is 6 C o u rt in lit ig a tio n su rro u n d in g th e p lain tiff s’ e x p o su re o f

p o ly c h lo rin a ted b ip h e n y ls (P C B s ) f ro m w o rk in g in o r l iv in g a d ja c e n t to a ra il- y a rd . I

n r e Pa o l iRa i lr o a d

Ya r d PCB Li t igat i on , 9 1 6 F . 2 d 8 2 9 (3d C ir . 1 9 9 0 ) (P a o liI) ; 35 F . 3 d 7 1 7 (3d C ir . 1 9 9 4 ) (P a o liII) ; 1 1 3 F . 3 d 4 4 4 (3d C ir . 1 9 9 7 ) (P a o liIII ) . I n P a o liII, thi s C our tfound thatm edi cal m on i t ori ng i s a vi able cl ai m un der Pen nsy l van i a l aw and re- art i culat ed the foll ow i ng t est f r o m P a o li I

, concl udi ng thatthes e el ement s ar e nec es s aryt o m ake outa medi cal m oni t or i ng cl ai m i n Penns y l vani a:

1. Pl ai nt i ff w as s i gni fi cant l yexpos ed t o a pr oven haz ar dous su b sta n c e th ro u g h th e n e g lig e n t ac tio n s o f th e d e f e n d a n t. 2. A s a proxi m at e res ultof ex po sure, plai nti ff suff ers a s i gni fi cant l yi ncr eas ed r i s k of contr act i ng a s er i ous l at ent di s eas e. 3. T hati ncr eas ed r i s k m akes per i odi c di agnos t i c medi cal e x a m i n a t i o n s r e a s o n a b l y n e c e s s a ry.18 4. M oni t or i ng and t es t i ng pr ocedur es exi s tw hi ch make the ear l ydet ect i on and tr eatm entof the di s eas e pos s i bl e and b e n e f icia l. 3 5 F .3 d a t 7 8 7 . P la in tif f id e n tif ie s a s in g le c a s e , Sut t on v. St . Jude M ed, S. C . , I

nc. , 419 F .3 d 5 6 8 (6 th C ir. 2 0 0 5 ), in w h ich a c o u rt su g g e ste d th a t re c o v e ryo f f u tu re m e d ica l co sts m i ghtbe appr opr i at e out s i de of the “t oxi c t or t ” cont ext . I n Sut t on , the Si xth C i r cui tfound that S u tt o n h ad stan d ing to se ek m ed ical t esti n g an d m o n it o ri n g all eg ed lym ad e n ec essa ry bythe i m pl ant at i on of a medi cal devi ce thathad noty etm al funct i oned orcaus ed Sut t on a n yp h y s ic a l in

ju ri e s . Id . at575. T he Sut t on C our tonl ydi s cus s ed bas i c s t andi ng doctr i ne; i tdi d notfi nd thatSut t on coul d r ecove rform edi cal m oni t or i ng, nordi d i tfi nd that m ed ical m o n it o ri n g co u ld b e a p p li ed as a fre e-stan d ing tortclaim in a n o n -t o x ic t o rt s c e n a ri o . T h u s, th e D istric t C o u rt’s p re d ictio n th a t th e D e law a re S u p re m e C o u rt w o u ld perm i ta cl ai m form edi cal m oni t or i ng on thi s r ecor d r equi r es s ever al “l eaps ” fr om the curr ents t at e of the l aw , gener al l y , l etal one D el aw ar e l aw . H er e, ther e i s no t oxi c or haza r dous s ubs t ance , as s uch. W hi l e unappr oved devi ces ar e t erm ed “a dul t er at ed”, they are notnecessari l yharm ful, and cert ai nlyno tt ox i c. M oreove r, the ri sk here i s not a r i sk o f “ c o n tr a c tin g a s e ri o u s la te n t d is e a s e .” R a th e r, i t is a ri s k o f th e n e e d f

o r f u rt h e r c a re . Fur therexami nat i ons ar e nott o “moni t or ” the r i s k of di s eas e, butt o per form r out i ne o v e rs ig h t. I n r e a c h i n g th i s c o n c l u s i o n , we d e c l i n e t o p r e d i c twh e th e rth e De l a wa r e S u p r e meW e a l s o n o t e th e w e l l - e s t a b l i s h e d p r i n c i p l e th a ta f e d e r a l c o u r ts i t t i n g i n d i v e r s i ty, 7 w h e n c a lle d u p o n to m a k e a p re d ic tio n o f s ta te la w , s h o u ld a c t c o n s e rv a tiv e ly. See, e. g. , D ay & Zi m m erm an, I

nc. v. C hal l oner , 4 2 3 U . S . 3 , 4 (19 7 5 ) (pe r cu ri am ) (“A fe d era l cou rt i n a di ver s i tycas e i s notfr ee t o engr aftont o thos e s t at e rul es exce pt i ons orm odi fi cat i ons w hi ch maycomm end themsel ves t o the fe der al court , butw hi ch have notcomm ended th e m se lv e s to th e S tate in w h ich th e f e d e ra l co u rt sits.” ); Trav elers I ndem ni t y C o. v. D am m ann & Co, I

nc. , 594 F. 3d 238, 253 ( 3r d C i r . 2010) ( “[I ] n r eac hi ng ourconcl us i on w e h av e e x erc ised restrai n t i n ac co rda n ce w ith the w ell -estab li sh ed p ri n ciple tha t w h ere ‘ tw o compet i ng y ets ens i bl e i nt erpr et at i ons ’ of s t at e l aw exi s t , ‘ w e s houl d optforthe i nt erpr et at i on thatr es tr i ct s l i abi l i ty , r atherthan expa nds i t , unt i l the Supr eme C our tof [th at st ate] d ec ides d iffe ren tl y ’. ” (intern al cit ati o n s o m itted)). 19 C our tm i ghtacknow l edge s om e var i antof a medi cal m oni t or i ng cl ai m . E ven i f the D el aw ar e Supr eme C our tw oul d r ecogni ze a“s t andar d” medi cal m oni t or i ng cl ai m , s uch as the one i dent i fi ed i n P a o li , w h ich re q u ir es a p lai n ti ff to d em o n str ate tha t a de fe n d an t’ s negl i gence caus ed the pl ai nt i ff t o be expos ed t o a pr oven haz ar dous s ubs t ance that r es ul t ed i n a s i gni fi cant l yi ncr eas ed r i s k of contr act i ng a s er i ous l at entdi s eas e, the pl ai nt i ff he r e ca nnotdemonstr at e thats he has been e xpos ed t o a pr oven haz ar dous subst ance, nor can she p rove that s uch exp osure r esul t ed in a si gn i fi cantl yi ncreased ri sk o f c o n tra c tin g a se rio u s la ten t d ise a se . A c c o rd in g ly , w e f in d th a t P lain tiff

is u n a b le to 7 es t abl i s h the el ement s nece s s aryt o m ake outa cl ai m form edi cal m oni t or i ng. Forthe forego i ng reas on s, w e revers e the o rderof the D i stri ctC ou rtden y i ng D efen dan t s’ m o tio n s f

o r su m m a ryju d g m e n t. I V. T h e D is tr ic t C o u rtis h e re b ya f f ir m e d in p a rta n d re v e rs e d in p a rt .