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
3-27-2009 

# B r uesewit z v

. W yeth Inc P r e c e de n t i al or N on-P r e c e de n t i al : P r e c e de n t i al D ocke t N o . 07-3794

F o l low thi s a nd a dd it ion al work s at : http://d i git alc ommon s .l a w . vi l l a no va . e du/thir dc ir c uit_2009

Thi s de c i sion i s br ou ght t o you for f r e e a nd ope n a c c e s s b y the 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 at V i l l a no va U nive r sity S choo l of L a

w Di git al Re posit or y

. It h as be e n a c c ept e d for inclusion in 2009 D e c i sion s b y a n author i z e d a dmini s tr at or of V i l l a no va U nive r sity S choo l of L a

w Di git al Re posit or y

. F or mor e inform at ion, p le as e c on t a ct Be n j amin
. C a rl s on@l a

w . vi l l a no va . e du
. Re c omme nde d C it at ion

" B r ue s ewitz v

. W ye th Inc " (2009). 2009 D e cisio n s . P ape r 1613. http://d i git alc ommon s .l a

w . vi l l a no va . e du/thir dc ir c uit_2009/1613

### 1 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 o. 07- 3794

_____________ RU SS ELL BRU ESEWI TZ; RO BA LEE BRU ESEWI TZ, par ent s and natur al guar di ans of H annah Brue s ew i t z, a m in o r c h ild a n d in th e ir o w n rig h t, A p p e llan ts

v. W YET H I NC. f /k /a W Y ETH LA BO RA TO RI ES, W Y ETH

- A Y ER ST

LA BO RA TO RI ES, W Y ETH LED ER LE, W Y ETH LED ER LE V A CC I N ES, AND LEDERLE LA BO RA TOR I ES

___________________ O n A p p ea l 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 i s t r i ctC our tN o. 05- cv- 05994 D i s t r i ctJ udge: T he H onor abl e M i chae l M

. B ay l s on

____________________2 A r gued Sept ember 11, 2008 B e f o re : M c K E E , S M IT H , a n d W E IS , C i rcui tJud ges ( Fi l ed: M ar ch 27, 2009) C ol l yn A

. Peddi e ( A r gued) W i l l i ams, K her kher , H ar t& B oundas 8441 G ul f Fr eew ay Sui t e 600 H ous t on, T X 77017- 5001 C ouns el f orAppel l ant R ee tu D an d o ra 1650 M ar ketSt r eet 2500 O ne Li ber t yPl ace Phi l adel phi a, PA 19103- 7301 C ouns el f orAppel l ee L a u re n E lli o tt R i char d W

. M ar k ( A r gued) D ani el J

. T hom as ch O r r i ck, H err i ngt on & Sut cl i ffe 666 Fi fth A venue N ew Y or k, N Y 10103 C ouns el f orAppel l ee H enryF. R ei chner M ich a e l T . S c o tt R e e d S m ith 1650 M ar ketSt r eet3 2500 O ne Li ber t yPl ace Phi l adel phi a, PA 19103 C ouns el f orAppel l ee

______________

OP I NI ON

______________ S M IT H , C i r cui tJudge.
T hi s appeal pr es ent s t hr ee que s t i ons r el at ed t o t he N at i onal C hi l dho o d V acc i ne I nj ur yA ct : ( 1) w hethert he A ct pr eempt s al l des i gn defe ctcl ai m s agai ns tt he manufactur erof a vacc i ne; ( 2) w hethert he p lai nt i ffs demonst r at ed thatt he m anufa ctur erfai l ed t o adequa t el yw arn t he pl ai nt i ffs of the r i s ks as s oci at ed w i t h t he vac ci ne; and ( 3) w hethert he pl ai nt i ffs p ro v id e d su f

f icie n t ev id e n c e o f

a m a n u f

a c tu rin g d e f

e c t to s ur vi ve the def

end ant ’ s m ot i on fors um m aryj udgm ent
. T he D i s t r i ctC our thel d that t he A ctpr eempt ed al l des i gn defe ct cl ai m s and conc l uded thatt he pl ai nt i ffs fai l ed t o pr ovi de s uffi ci entevi dence t o s uppor tt he ot hert w o cl ai m s . For t he re a s o n s th a t f

o llo w , w e w ill a f

f ir m . I. A.
H i s t or i cal l y , t he s t at es have pos s es s ed “gr eatl at i tude4 under t hei r pol i ce pow er s t o l egi s l at e as t o t he pr ot ect i on of the liv e s , lim b s , h e a lth , c o m f o rt , a n d q u ie t” o f

th e irc itiz e n s . Metr o. L ife In s. C o . v. Ma ss a c h u se tts , 4 7 1 U .S

. 7 2 4 , 7 5 6 (1 9 8 5 ). T h is has been true w i t h r egar d t o drugs , as t he S u p rem e C our thas d ec lared it “w ell sett led t h at the S tat e ha s b roa d p o li ce p o w ers in re g u latin g th e a d m in istra tio n o f d ru g s b yth e h e a lth pr ofes s i ons . ” W

hal en v. R oe , 429 U

. S. 589, 60 3 (19 7 7 )

. A nd t he poli ce p o w er s ext end t o i m m uni zat i on, as s t at e and l ocal author i t i es have r es ponded t o i l l nes s es l i ke s m al l pox and s ought t o i nocul at e mem ber s of the popul ous . C ent erforB i ol ogi cs E val uat i on and R es ear ch, Food and D rug A dm i ni s t r at i on, Sci ence and the R egulat i on of B i ol ogi cal P r oduct

s : Fr om a R i ch His t or y t o a C hal l engi ng Fut ur e 8 ( 2002)

. D es pi t e ca l l s i n t he late n in e tee n th -c e n tu ryf o r th e f e d e ra l re g u latio n o f

v a c c in e s to p ro m o te u n if

o rm sa f e tyre g u latio n s, C o n g re ss d id n o t ac t u n til 1 9 0 2 , w h e n th irtee n c h ild re n d ied a f te r b e in g v a c c in a ted w ith c o n ta m in a te d d ip th e ri a a n tito x in

. Id

. at12

. O ver t he p ast century , how ever , t he fe der al governm enthas t aken a pr edomi nat e r ol e i n appr ovi ng, r egul at i ng, and prom ot i ng v a c c in e s— f

ro m th e p a ss a g e o f

th e B io lo g ics C o n tr o l A c t in 1 9 0 2 , P u b . L . N o . 5 7 -2 4 4 , w h ich a u th o riz e d a f e d e ra l ag e n c yto iss u e re g u latio n s re late d to v a c c in e s, to th e P u b lic H e a lth Ser vi ce A ct , Pub. L

. N o. 78- 410, w hi ch r equi r ed fe der al author i t i es t o l i cens e vacci nes and vacci ne manufactur er s , t o t he E m er gency

Suppl em en tal A p p rop ri ati ons A ctforR ecove ryfr om a n d Re s p o n s e t o Te r r o r i s t At t a c k s o n t h e Uni t e d St a t e s , Pu b

. L. N o. 107- 9, w hi ch appr opr i at ed money for the ac qui s i t i on of a s uffi ci ent quant i t y of t he s m al l pox vacc i ne t o i nocul at e theT he V acc i ne A ct cr eat ed t he “V acc i ne I nj ur yT abl e. ” 42 1 U

. S

. C

. § 3 0 0 a a -14

. Itset s forth the “vaccines, t he inj uri es, di s abi l i t i es , i l l nes s es , condi t i ons , and deaths r es ul t i ng fr om t he admi ni s t r at i o n ” o f vacci nes forw hi ch i ndi vi dual s m ays eek c o m p e n s a tio n . I

d. 5 c o u n tr y . T he N at i onal C hi l dhood V acc i ne Inj ur yA ct( “V acc i ne A ct ”) i s one s uch ef

for t
. P. L

. 99- 660, T i t l e I I I , 100 St at
. 3743, 3756–3784 ( codi fied at42 U

. S. C

. § 300aa- 1 et s eq. )

. E nact ed i n 1986, t he V acc i ne A ctes t abl i s hed a na t i onal vacc i ne pr ogr am t o “ac hi eve opt i m al pr event i on of hum an i n fect i ous di s eas es t hroug h im m un i z a t i on a ndt o a chieve op t i m al preven t i on against adver s e r eac t i ons t o vacc i nes . ” 42 U

. S. C

. § 300aa- 1. I ts ought t o acc om pl i s h t hi s pr i m ar i l yt hr ough t he cr eat i on of the N at i onal Va c c i n e I n

j u r yCo mp e n s a t i o n P r o g r a m ( “ NVI CP ” ) fo rc l a i ms agai ns tdrug m anufa ctur er s forvacc ine-rel at ed i nj ur i es and deaths

. 42 U

. S. C

. § 300aa- 10 et s eq. T h e N V I C P has t w o par t s . Par tA cr eat es a mandat o ry forum for t he admi ni s t r at i on of cl ai m s

— i tr equi r es a pet i t i oner s eeki ng compensa t i on , i ncl udi ng t he i nj ur ed part y ’ s l egal r epr es ent at i ve, t o fi l e a petit i on i n t he “V acc i ne C our t , ” w hi ch is p a rt o f th e U n ite d S ta te s C o u rt o f F e d e ra l C la im s . I

d. a t § 300aa- 11. T he pet i t i oner i s ent i t l ed t o r ece i ve compens at i on i f: ( 1) t he af

fec ted per s on r ece i ved a va cci ne cove r ed byt he V acc i ne A ct ; ( 2) t he af

fec t ed per s on s uffe r ed a “Tabl e i nj ur y ”; 1

### T h e p arty al s o has t he opt i on of appe al i n g the C our tof 2 F e d e ra l C laim s’ ju d g m e n t to th e U n ited S tate s C o u rt o f A p p e a ls forthe Feder al C i r cui t
. 42 U

. S. C

. § 300aa- 12( f)


### . 6 and ( 3) i t cannot be show n bya pr eponder ance of the evi dence th a t th e in

ju ri e s o r d e a th w e re n o t c a u s e d b yth e v a c c in e . I d. at § § 3 0 0 aa -11 , 3 0 0 aa -13

. A lt ern ati v ely , a p eti ti o n er w h o su ff ers a non- T abl e i nj ur ym ays t i l l obt ain com pens at i on bypr ovi ng a f f ir m a tiv e ly th a t th e v a c c in e c a u s e d th e i n ju ry. See G r antv. S e c ’ y o f HHS , 956 F. 2d 1144, 1148 ( Fed. C i r . 1992)

. Par tB of t he N V I C P per m i t s a pet i t i oner , aft ert he V ac cine Courthas iss u e d a f in a l ju d g m e n t, t o e ith e r ac c e p t o r reje c t th a t ju d g m e n t. 42 U

. S. C

. § 300aa- 21 et s eq . I f the pet i t i onerr ej ect s t he j udgm ent , s he maypur s ue ce r t ai n l i m i t ed cl ai m s i n sta t e or f e d e ra l co u rt. 4 2 U .S .C . § 3 0 0 a a -2 1

.

2
B . Ha n n a h Bru e s e wi t z wa s b o r n o n Oc t o b e r2 0 , 1 9 9 1

. At t he t i m e, t he fed era l A dvi s or yC om m i t t ee on I m m uni zat i on Pr act i ces r ecomm ended thatchi l dr en r ece i ve fi ve dos es of the dipht heri a-per tussi s- t et anu s (“D P T ”) va cci ne du ri ng t he co urse o f th eir ch il d h o o d , o n e d o se a t eac h o f th e f o ll o w ing ag es: (1) 2 m ont hs ; ( 2) 4 m ont hs ; ( 3) 6 m ont hs ; ( 4) 15- 18 m ont hs ; and ( 5) 4- 6 y e a r s . H a nn a h r e c e i ve d h e r fi rs tt hr e e s ho t s of t he D PT v a c c in e a c c o rd in g to th is sc h e d u le. A f ter th e th ird D P T s h o t, m ar ket ed unde rt he tr ade na m e TR I

- I M M U N O L and adm i nis t ered on A pri l 1, 19 92 , she s uff ered a ser i es of sei zures.

### Th e N at i onal H eal t h I ns t i tut e fi r s ti s s ued a pr oduct 3 lice n se f o r T R I-IM M U N O L in 1 9 4 8 to A m e r ic a n C y a n a m id C om pany (“C y an am id”)

. L eder l e Labor at or i es , an u n inco rpo rate d d ivisi o n o f C y an am id, pro d u ce d T R II M M U N O L

. I n 1994, A m er i can H om e Pr oduct s C orpor at i on ( “A H PC ”) acqui r ed C y anami d. I n M ar ch 2002, A H PC change d i t s name t o 

### Wyeth

. 7 D oct or s s ubs equent l ydi agnos ed H annah as havi ng r es i dual s ei zur e di s or der and devel opm ent al del ay . H annah, w ho i s now s event een, w i l l l i kel y r equi r e s om e medi cal car e r el at ed t o t hat c o n d itio n f

o r t h e re m a in d e r o f

h e r l if e . D ef en d an t W y eth, In c . an d it s p red ec esso rs ( “W y eth”) 3 m anufa ctur ed TR I

- I M M U N O L unt i l 1998. A ppr oved i n 1948, th is v a c c in e c o n ta in s th e “ w h o le- c e ll” p e rtu ss is v a c c in e

— it i s prepared usi ng w ho l e, i nacti vated pertussi s bact eri al cel l s. A lth o u g h th e w h o le- c e ll v a c c in e e f f e c tiv e lyre d u c e d p e rtu ss is i n fe cti ons and dea t hs as s oci at ed w i t h t hes e i nfec t i ons , i tw as a lso lin k e d to a v a rie ty o f a d v e rse e v e n ts. T h is l e d to in ter e st in and ef for t s t o devel op a s afe r , ace l l ul arper tus s i s vacc i ne. I n D ece m ber1991, t h e Food and D rug A dm i ni s t r at i on (“ F D A ” ) a p p ro v e d th e d e f e n d a n t’s a p p lica tio n f

o r a n a ltern a te D PT va c c i n e , whi c h was k n o wn a s AC EL- I M UN E. AC ELI M U N E cont ai ns an ac el l ul arper tus s i s component
. W hil e the acel l ular v a c c i ne co ntai ns part s of pe rtussi s bact eri al cel l s, b e c a u se it d o e s n o t co n tain a c o m p lete c e ll, it h a s le ss e n d o to x in

### T h e acellu lar p ertu ssis v accin e co ntain s p e rtu ssis to x in 4 

### and o ther bact eria l c om

po nents. Th es e c om

po nents, ho wever, ar e l es s r ea ctive and cau se f ewer advers e e vents bec ause they h av e b eend e t o x if

iedu sin g ch emical o r g en etic techn iqu es. C enters f

o r D isease C o ntro l an dP rev e n tio n , P ertu ssis Va c c i nat i on: Ac e l lul ar

Pe rt us s i s Va c c i ne for

the Fourth and Fifth D oses of

the D PT Seri es ; Upd at e t o S up plem entary AC IP St at Re c omm e ndat i ons of the Advi s ory Commi tt e e on I m m uni z a t i on Pr a c t ices, O cto b er 9 , 1992, ht t p : / / www . c d c . g o v/

mmwr / p re v iew/m

m wr ht ml/ 0 0 0 4 8 6 1 0

. ht

m. 8 a n d is le ss lik e lyto c a u se a d v e rse e v e n ts. T h e F D A in iti a lly 4 appr oved A C E L

- I M U N E , how ever , foradmi ni s t r at i on as t he f o u rth a n d /o r fif

th D P T d o se in th e se rie s o f f iv e . T h e F D A d id notappr ov e an acel l ul arper tus s i s vacc i ne fort he fi r s tt hr ee shots i n the ser i es unti l Jul y19 96 w hen i tapp roved the l i cense o f Co n n a u g h tL a b o r a t o r i e s , I n c . De f e n d a n t ’ s AC E L

- I M UNE di d notr ece i ve appr oval fort hes e s ame dose s u n ti l D ece m ber 1 9 9 6

. N onethel es s , att he t i m e of va cci nat i on in A pr i l 1992, H annah’ s d oct oradmi ni s t er ed the TR I

- I M M U N O L vacc i ne b e c a u se th e re w e re n o a c e llu lar p e rtu ss is v a c c in e s c o m m e rc ially a v a i l a b l e f

o r t h e t h i r d d o s e . Ha n n a h ’ s p a r t i c u l a rv a c c i n e c a me fr om a l ot t hat gener at ed si xt y - fi ve re por t s of adver s e r eac t i ons w i t h t he F D A and C ent er s forD i s eas e C ont r ol and Pr event i on, in c lu d in g th ir ty- n in e e m e r g e n c y r o o m v isits, six hos pi t al i zat i ons , and tw o deaths

. H annah’ s phy s i ci an l at er

### Ef fect ive M a rc h 1 0 , 1 9 9 5 , ap p ro x im a telyo n e m o n th 5 b e f o re th e p lain tiff

s f iled th e ir p e tit io n w ith th e V a c c in e C o u rt, n e w re g u la ti o n s d e lete d re sid u a l se izu re d iso rd e r a s a T a b le in ju ry f o r D P T v a c c in e . B r u e s e wi t z v . S e c ’ y o f De p ’ to f HHS , N o. 95- 0266V , 2002 W L 31965744, at *1 n. 1 ( Fed. C l

. D ec. 20, 2 0 0 2 ); see al

so N at i onal V acc i ne I nj ur yC om pens at i on Pr ogr am R evisi o n of t he V acc i ne I nj ur yT abl e, 60 Fed. R eg. 7678, 7689–91 ( Feb. 8, 1995 

### ). 9 i ndi cat ed, as par tof t h is li t i gat i on, t hats he w oul d nothave im m u n ize d H a n n a h h a d sh e k n o w n o f th e a d v e rse e v e n t re p o rts a s s o c ia te d w ith th is lo t o f th e v a c c in e . I n 1998, W y eth vol unt ar i l ydi s cont i nued manufactur i ng TRI

- I M M UN OL. C.
H annah’ s par ent s ( “pl ai nti ffs”) f i l ed a pe t i t i on i n t he V acc i ne C our t i n A pr i l 1995, al l egi ng t hat H annah suf fer ed an o n - T a b l e r e s i d u a l s e i z u r e d i s o r d e ra n d e n c e p h a l o p a t h y. 5 B r u e s e wi t

z v . S e c ’ y o f De p ’ to f HHS , N o . 9 5

- 0 2 6 6 V , 2 0 0 2 WL 31965744, at*1 n. 1 ( Fed. C l

. D ec. 20, 2002)

. T he C our thel d a hear i ng i n J ul y2002 and conc l uded i n D ece m b er o f thaty ear t hatH an n ah’ s i nj ur i es w er e non- T abl e i nj ur i es and thatt he p e titio n e rs h a d n o t p ro v e n c a u s a tio n in f a c t. Id

. at *13–17. A c c o rd in g ly, it d is m is s e d th e c la im w ith p re ju d ic e . I d. at*17. H annah’ s par ent s r ej ect ed t he C our t ’ s j udgm enton February14,10 2 0 0 3

. H avi ng exhaus t ed thei radmi ni str at i ve r emedi es , t he pl ai nt i ffs fi l ed a C om pl ai nti n t he Phi l adel phi a C our tof C om m o n P leas i n O ct ober2005. T he compl ai nts ought r ecove r yon fourcl ai m s : ( I ) negl i gentfai l ur e t o pr oduce a s afe r vacc i ne; ( I I ) negl i gentfai l ur e t o w arn; ( I I I ) s t r i ctl i abi l i t y for d e sig n d e f

e c t; an d (IV ) stric t li a b ili ty f o r m a n u f a c tu rin g d e f

e c t. W y eth r emoved t he ac t i on on t he bas is o f di ver s i t yt o t he E astern D istri ct o f P en n sy lvan ia a n d fil ed a m o ti o n fo r sum m ary j ud gm ent
. T he D i s t r i ctC our tdeni ed the mot i on w i t hout p r e j u d i c e b e c a u s e t h e p a r t i e s h a d n o t e n g a g e d i n d i s c o v e r y. Fol l ow i ng compl et i on of di s covery , W y eth agai n m oved for s u m m a ry ju d g m e n t o n a ll f o u r c o u n ts
. A lth o u g h the D istri ct C o u rt d id n o t acc ep t al l of W y eth’s th e o rie s, it g ra n ted su m m a ryju d g m e n t in W y e th ’s f a v o r o n a ll count s on A ugus t 24, 2007. T he D i s t r i ctC our tconcl uded that Sect i on 22( b) ( 1) of the V accin e A ct , 42 U

. S. C

. § 300aa2 2 ( b ) ( 1 ) , pr e e mpt s a l l d e s i g n d e f e c tc l a i ms a r i s i n g f

r o m a vacc i ne- r el at ed i nj ur yor death and di s m i s s ed C ount s I and I I I on that b asis. R eg ard ing C o u n t II, w h ich all eg ed n eg li g en t fail u re t o w arn, t he D i s t r i ct C our t concl uded t hatt he pl ai nt i ffs had not r ebut t ed the s t atut or ypr es um p ti on cr eat ed bySect i on 22( b) ( 2) o f th e V ac cine A ct, 4 2 U

. S

. C

. § 3 0 0 aa -22 (b)(2 ), that W y e th ’s FD A

- compl i antw arni ngs w er e pr oper . A s t o C ountI V , w hi ch al l eged t hat the p art i cularl ot fr om w hich H ann ah’s dose or i gi nat ed w as es peci al l ypr one t o adver s e r eac t i ons due t o a11 m anufa ctur i ng defe ct , t he D i s t r i ctC our tconcl uded thatt he pl ai nt i ffs had fa i l ed t o pr es ents uffi ci ent evi dence t hatt he l ot w a s d e f e c tiv e o r t h a t it c a u s e d H a n n a h ’s in ju ri e s . Th e Di s t r i c tCo u r t ’ s ru l i n g o n t h e f i r s ta n d t h i r d c l a i ms w arr ant s fur t herexa m i nat i on. B ot h count s al l eged a des i gn d e f e c t— C o u n t I a lleg e d th a t H a n n a h ’s v a c c in e w a s n e g lig e n tly des i gned bec aus e the defe ndant knew of a s afe r al t ernat i ve and fai l ed t o pr oduce i t , w hi l e C ountI I I al l eged s t r i ctl i abi l i t ydes i gn d ef ec t. T h e D istri ct C o u rtruled that b o th claim s w ere pree m pt ed byt he V acc i ne A ct
. I tr es t ed thi s deci s i on on four poi nt s . Fi r s t , i t stated t hata ca s e- by

- cas e cons i der at i on of w hethera vac ci ne w as unavoi dabl ys afe w oul d notpr ot ect vacc i ne manufactur er s fr om s ui t
. Second, i tr eas oned that C ongr es s pas s ed t he V acc i ne A ct t o “pr ovi de an umbr el l a under w h ich m a n u f

a c tu re rs w o u ld im p ro v e th e sa f e tyo f th e ir p ro d u c ts w hi l e r emai ni ng i m m une fr om des i gn defe ct cl ai m s . ” T hi r d, t he C our tfound t hatC ongr es s achi eved a n appr opr i at e bal ance by o f f s e t t i n g t h e e f

f e c to f t h e p r e e mp t i o n o f

d e s i g n d e f

e c tc l a i ms w i t h cr eat i on of a c om pens at i on pr ogr am for i ndi vi dual s i nj ur ed byvacc i nes . Fi nal l y , i tconcl uded thatt he V acc i ne A ct p r e e mp t s b o t h s t r i c t l i a b i l i t y a n d n e g l i g e n td e s i g n d e f e c tc l a i ms agai ns t F D A

- appr oved vac ci nes . A ccor di ngl y , i tdi s m i s s ed p la in tif f s ’ f ir s t a n d th ir d c la im s . T h e p lai n ti ff

s ap p ea led. T h eir a p p ea l p rese n ts th is C o u rt w ith th ree quest i on s: (1) do es § 30 0aa-22 (b) (1) actas a c o m p lete b a r to d e sig n d e f e c t c laim s; (2 ) h a v e th e p lain tiff s in12 t hi s cas e met t hei r bur den under§ 22( b) ( 2) of the V acc i ne A ct t o s how thatdefe ndan ts f ai l ed t o pr ovi de an a dequat e w arni ng of t he al l eged danger s of t he vacc i ne; and ( 3) have the pl ai nt i ffs p ro v id e d su f

f icie n t e v id e n c e o f

a m a n u f

a c tu rin g d e f

e c t to su rv iv e th e d e f

e n d a n t’s m o tio n f

o r su m m a ryju d g m e n t. II. Th e D i s t r i c tCo u r th a d j u r i s d i c t i o n u n d e r2 8 U. S

. C. §§ 1332 and 1441, and w e have appel l at e j ur i s di ct i on under28 U

. S. C

. § 1291. O urr evi ew of a D i s t r i ctC our t ’ s gr antof su m m ary jud g m en t is p lena ry , an d w e a p p lythe s am e stan d ard as t he D i s t r i ctC our tt o det er m i ne w hethers um m aryj udgm ent w a s a p p r o p ri a te
. N

or f olk S. Ry. C o. v. B as el lU SA I nc. , 512 F .3 d 8 6 , 9 1 (3 d C ir. 2 0 0 8 ). A g ra n t o f su m m a r y j u d g m e n t is ap p rop ri a te “if the p lead ing s, the d isco v eryan d d iscl o su re m at er i al s on fi l e, and anyaff i davi t s s how t hatt her e i s no g e n u in e iss u e a s to a n ym a ter ia l f a c t an d th a t th e m o v a n t is en ti tl ed to jud g m en t as a m att er o f law

. ” F ed

. R

. C iv. P

. 5 6 (c). I n m aki ng t hi s det er m i nat i on, w e mustvi ew t he fa ct s i n t he l i ght m os t favor abl e t o t he nonmovi ng part yand dr aw al l i nfer ence s in th a t p a rt y ’s f

a v o r. N o rfo lk , 512 F. 3d at91.
III . P reem pti on do ct ri ne is ro o ted i n the Su prem acyC l ause of t he U n i t ed St at es C ons t i tut i on. A r t i cl e V I decl ar es t hatt he l aw s of t he U ni t ed St at es “sha ll b e the s upr eme L aw of the13 L a n d ; . . . an yT h in g in th e C o n stitu tio n o r L a w s o f a n yS tate to t he C ont r arynot w i t hs t andi ng. ” U

. S. C ons t
. ar t
. V I , cl

. 2.

“ U n d e r th e S u p re m a c yC lau se , fe d e ra l law m a ysu p e rse d e sta te l aw i n s eve ral di ffe r entw ay s . ” Hi l l s bor ough C ount

y, F l a. , v. A ut om at ed Med. Labs. , I nc. , 471 U

. S. 707, 713 ( 1985)

. O ver t he y ear s , t he Supr eme C our thas r ecogni zed thr ee types of pr eempt i on: expr es s pr eempt i on, i m pl i ed conf l i ctpr eempt i on, a n d f ie ld p re e m p tio n . I

d.
A f e d e ra l en a c tm e n t ex p re ss lyp re e m p ts s ta te la w if it c o n ta in s la n g u a g e s o re q u ir in g . L o rilla rd T o b a c c o C o . v . R e ill

y , 53 3 U

. S

. 52 5, 54 1 (200 1). T hu s, w he n co nst rui ng an ex press pr eempt i on cl aus e, a re vi ew i ng cour tm us tnece s s ar i l ybegi n by e x a m in in g th e “ p lain w o rd in g o f th e c lau se ,” a s th is “ n e c e ss a rily c o n ta in s th e b e s t e v id e n c e o f C o n g r e s s ’ p re -e m p tiv e in te n t.” Spr i et s m a v. Mer cur

y Ma ri ne , 537 U

. S. 51, 62–63 ( 2002) ( quot i ng CSX

Trans p. v. E as t er w ood , 5 0 7 U

. S. 658, 664 ( 1993) )

. T hough t he l anguage of t he pr ovi s i on offe r s a s t ar t i ng p o in t, co u rts a re o f

te n c a lled u p o n to “ id e n tifyth e d o m a in e x p r e s s l y p r e - e mpt e d b y t h a t l a n g u a g e . ” Medtr oni c, I nc. v. Lohr , 518 U

. S. 470, 484 ( 1996) ( interna l quot at i on m ar ks and c ita tio n s o m itte d ). T h is , in tu rn , is g u id e d b y tw o p ri n c ip le s . I d. a t 4 8 5 . F irst, “C o n g re ss io n a l p u rp o se is th e ‘u lti m a te t ouchs t one’ of ouri nqui r y . ” Lori l l ar d Tobacco C o. , 533 U

. S. at 5 41 ( quot i ng C i

pol l one v. Ligget tG r oup, I nc. , 5 0 5 U. S. 504, 5 1 6 (1 9 9 2 )); see al

so A l tr i a G r oup, I

nc. v. G ood , 129 S. C t
. 538, 5 4 3 ( 2 0 0 8 ) ( “ I f

a f e d e r a l l a w co n t a i n s a n e x p r e s s p r e - e m pt i on cl aus e, i tdoes noti m m edi at el yend the i n q u ir ybeca us e the14 ques t i on of t he s ubs t ance and s cope of C ongr es s ’ di s pl ace m ent of st at e l aw s t i l l r emai ns . ”)

. Second, cour t s m us toper at e under t he “a s s um pt i on t hatt he hi s t or i c pol i ce pow er s of the St at es [a] r e nott o be s uper s eded byt he F eder al A ctunl es s t hat[i s ] t he cl ear an d m ani fes tpurpos e of Congre s s . ” C al

. D i v. of Labor St andar ds E nf

or cem ent v. D il li ngham C ons tr . , N

. A

. , I nc. , 519 U

. S

. 3 1 6 , 3 2 5 (19 9 7 ).
Im pl i ed conf

l i ctpr eempt i on ar i s es w hen s t at e l aw c o n f licts w ith a f

e d e ra l s tatu te in o n e o f tw o situ a tio n s. F irst, it a rise s w h e n it is “im p o ss ib le f o r a p riv a te p a rtyto c o m p lyw ith bot h s t at e and fede r al r equi r ement s . ” E ngl is h v. G ener alE l ec. C o. , 4 9 6 U .S . 7 2 , 7 8

– 7 9 (1 9 9 0 ). It is a lso p re se n t w h e n sta te l aw “s t ands as an obs t acl e t o t he accompl i s hm ent and exe cut i on of t he ful l purpos es and obj ect i ves of C ongr ess. ” Hi nes v. D a v id o w itz , 312 U

. S. 52, 67 ( 1941)

. Fur t her m or e, im p li ed pr eempt i on m ay exi s t even i n t he fac e of a n expr es s pr eempt i on cl aus e. A s t he Supr eme C our tobs er ved i n Fr ei ght l i nerC or

p. v. M yr i ck , 514 U

. S. 280, 288 ( 1995) , “C ongr es s ’ enac t m entof a pr ovi s i on defi ni ng t he pr eempt i ve r eac h of a s t atut e i m pl i es t hat m at t ers be y ond t hatr eac h ar e notpr e- empt ed, ” butt hat“does notm ean thatt he expres s cl aus e ent i r el yfor ecl os es any pos s i bi l i t yof i m pl i ed pr e- empt i on. ”
W hen conf

r ont i ng ar gum ent s t hata l aw s t ands as an o b sta c le to C o n g re ss io n a l o b jec tiv e s, a c o u r t m u st u se its ju d g m e n t: “W h a t is a su f f icie n t o b sta c le is a m a tter o f ju d g m e n t, t o be i nfor m ed by exami ni ng t he fe der al s t atut e as a w hol e and15 i d e n t i f y i n g i t s p u rp o s e a n d i n t e n d e d e f f e c t s . ” C ro sb

y v . N a t’ l Fo re ig n T

ra d e C o u n c il , 5 3 0 U. S

. 3 6 3 , 3 7 3 ( 2 0 0 0 )

. I n f a c t , we m us tl ook t o “‘ t he ent i r e s cheme of t he s t atut e’ ” and det er m i ne
“‘ [i ] f t he purpos e of the [f eder al ] actcannotot herw i s e be acc om pl i s hed— i f i t s oper at i on w i t h i t s chos en fi el d [w oul d] be frus t r at ed and i t s pr ovi s i ons be r efus ed thei rnatur al eff ect
. ’ ” I d. ( quot i ng Savage v

. Jones , 225 U

. S. 501, 533 ( 1912) )

. O nce a g a in , this re q u ire s a n e x a m in a tio n o f th e “ ‘w h o le law , a n d to its obj ectand pol i cy . ’ ” 

### Gadev. Nat ’ l Solid W as tes Mgmt

. Ass n. , 50 5 U .S. 88, 98 (199 2) ( quot i ng P i l ot Li f e I ns . C o. v. D edeaux , 4 8 1 U .S . 4 1 , 5 1 (1 9 8 7 ))

. Field pr eempt i on ar i s es byi m pl i cat i on w hen s t at e l aw occupi es a “fi el d r es er ved forfede r al r egul at i on. ” U ni t ed Stat es v. Locke , 52 9 U

. S

. 89 , 11 1 ( 20 00 ). T his occu rs w hen “C on gress [] leftno r oom fors t at e r egul at i on of thes e mat t er s . ” I d. ; s ee al s o Lori l lard T

o bacco Co. , 533 U

. S. at541. I tm ayal s o be i nferr ed w hen “a n A ctof C ongr es s ‘ t ouch[e s ] a fi el d i n w hi ch t he feder al i nt er es t i s s o dom i nantt hatt he fe der al s y s t em w i l l be a s s u me d t o p r e c l u d e e n f o r c e me n to f

s t a t e l a w s on t h e s a me s ubj ect
. ’ ” En g l is h v . Gen

. El e c . C o. , 4 96 U

. S. 72, 79 ( 1990) ( quot i ng R i ce v . Sant a Fe E le vat orC or p. , 331 U

. S. 218, 230 ( 1947) )

. N onethel es s , beca us e fi el d pr eempt i on t ypi cal l yar i s es in areas t r adi t i onal l yr egul at ed bys t at es undert hei rpol i ce pow er s , “congr es s i onal i nt entt o s uper s ede s t at e l aw s m us tbe

‘ cl earand mani fes t
. ’ ” I d. (c ita tio n o m itte d ).
Y et des pi t e t he deve l opm entof the for egoi ng pr eempt i on16 j uri spruden ce, cou rt s m ustbeg i n thei r a n a ly si s of t hese questi o ns byappl y i ng a pr es um pt i on agai ns tpr eempt i on. C i pol l one v. Ligget tG r oup, I nc. , 5 0 5 U

. S

. 5 0 4 , 5 1 6 (19 9 2 ). “In ar eas of t r adi t i onal s t at e r egul at i on, w e as s um e thata fe der al s t atut e has not su ppl ant ed s t at e l aw unl es s C ongr es s has m ade s uch an i nt ent i on ‘ cl earand mani fes t
. ’ ” B at es v. D ow A gr oSci ence s , 5 4 4 U. S

. 4 3 1 , 4 4 9 ( 2 0 0 5 )

. Wh e n f a c e d wi t h t wo e q u a lly p lau sib le re a d in g s o f sta tu to ry tex t, w e “ h a v e a d u tyto acc eptt he r eadi ng t hatdi sfa vor s pr eempt i on. ” Id; see al so A l tr i a G r oup, I

nc. , 1 2 9 S . C t. at 5 4 3 ; C i pol l one , 505 U

. S. at518. T h i s i s t rue eve n i n t he eve ntof an e xpr es s pr eempt i on cl aus e. R i egel v. Medtr oni c, I

nc. , 128 S. C t
. 999, 1014 ( 2008) ( quot i ng B ates , 544 U

. S. at449)

. T hat i s s ues of hea l t h and s afe t yhave tra d iti o n a llyf

a llen w ith in th e p ro v in c e o f s ta te r e g u latio n is bey ond r efut e. T hats afe t yof vacc i nes i s an i s s ue of he al t h and s a f e ty is e q u a lly c le a r. See, e. g. , Medtr oni c, I nc. , 5 1 8 U. S. at 485. N onethel es s , i n t he fa ce of cl earevi dence , t he pr es um pt i on a g a in s t p re e m p tio n c a n b e o v e rc o m e . See C r os by , 530 U

. S. at 3 7 4 n .8 . (“ A s s u m in g , ar guendo , t hat s om e presum pti on against p re e m p tio n is a p p ro p ria te, w e c o n c lu d e , b a se d o n o u r a n a ly sis b e lo w , tha t th e sta te A c t p re se n ts a su f f icie n t o b sta c le to th e f

u ll acc om pl i s hm entof C ongr es s ’ s obj ect i ves under t he feder al A ct to f in d it p re e m p te d .” ).
W e mu s td e c i d e her e w hethert he pl ai nt i ffs ’ des i gn defe ct clai m s ar e pr eempt ed. A s w e have not ed, t he D i s t r i ctC o u rt re a so n e d th a t f

o u r p o in ts c o u n se led in f a v o r of f in d in g th a t b o th cl ai ms wer e p r e e mpt e d b yt h e Vac c i n e Act : ( 1 ) i f t h e Vac ci ne

### T h e p laintif f s ar gue thatt he D i s t r i ctC our t ’ s deci s i on 6 vi ol at es t he pr i nci pl e thata “di s t r i ctcourt m aynotgr ant su m m a ryju d g m e n t su a sp o n te on gr ounds not r eques t ed byt he m ovi ng par t y . ” J

o h n Dee r e Co. v . Am. Nat ’ lBa nk , 809 F. 2d 1 1 9 0 , 1 1 9 2 (5 th C ir . 1 9 8 7 ). 

### T h is C o urt h as p rev io u sly re m anded a cl ai m

beca use the Distri ct

Co urt granted summ ar

y judgm e nt on agr ound not

offe r e d i n the m ovi ng party ’ s m ot i on. 17 A ctper m i t t ed ca s e- by

- cas e cons i der at i on of des i gn d efect cl ai m s , t he A ctw ould do l i t t l e t o pr ot ectm anufa ctur er s fr om s ui t ; ( 2) C ongr es s i nt ended the V acc i ne A ct t o encour age vacc i ne i m pr ovement s w hi l e pr ovi di ng i m m uni t yfordes i gn defe ctcl ai m s ; ( 3) C ongr es s achi eved a balan ce bet w een m anufa ctur er s and pat i ent s bycr eat i ng t he c o m pens at i on s y s t em to o f f se t d e sig n d e f

e c t im m u n ity ; an d (4 ) th e V a c c in e A c t is b ro a d e r th a n c o m m e n t k o f th e R e sta tem e n t (S e c o n d ) o f T o rts § 402A s uch thatt he A ctencomp asses both s t r i ctl i abi l i t yand negl i gence cl ai m s . A t t he s ame t i m e, t he D i s t r i ctC our tdi d not exp l i ci t l yl ay ou t a fram ew ork fo r com i ng t o these conclusi on s, n o r d id i tst at e w hethert heyw ere pr edicat ed o n ex press , im p lie d , o r f

ie ld p re e m p tio n g ro u n d s . P lain tiff s n o w se e k to tu rn su c h a m b ig u ityto th e ir advant age b y ar gui ng t hatt he D i s t r i ctC our t ’ s deci s i on w as “bas ed on s om e ki nd of i m pl i ed orfi el d pr eempt i on” w hen the defe nd ant’ s m oti on for sum m aryj ud gm ent rai sed on l yexp res s pr eempt i on. T hi s , t heym ai nt ai n, vi ol at ed “w el l- s et t l ed s um m aryjud g m en t pri n ciples.” A cc o rdin g ly , w e m us tcons i der 6

### Brobs t v . Columbus Se rv s . I nte rn. , 76 1 F.2d 1 48 , 159 (3d C ir

. 1 9 8 5 ). F o r th e reaso n s th at f o llo w , w e n e e dn o t d ecid e th is i s s u e . W e n o t e , h o w e v e r , th at o ur r u l i n g i n B ro b st

was p red icated o na d istrict co urt’s o b lig atio nto p ro v id e n o tice to the part i e s be for e r

ul i ng on a part i c ul ar i s s ue . I n thi s c a s e , the plai ntiffs argu ed in thei r r es po ns e to the m otion f or summ ar

y judgm e nt about th e pr opri e ty

of r ul i ng on i m

pl i e d pr e e m

pt i on gr ounds , the r e by

i ndi c at i ng that

the y we r e on n o tice that

the Di s tri c t Court m ay

have be e n c ons i de ri ng i m pl i e d pr e e m

pt i on at th at tim e an df

urth erm o re th at th ey h adano p p o rtun ity to resp o n do nth is issu e. 18 fou r q u est i ons r el at ed t o t he pr eempt i on of the des i gn defe ct cl ai m : (1) w h e th er § 300 aa-22(b) const i tutes an ex press p re e m p tio n p ro v isio n ; ( 2 ) w h e th e r w e m a y u se tra d iti o n a l to o ls of s t atut or yi nt erpr et at i on, i ncl udi ng l egi slat ive hi s t or y , w hen c o n stru in g su c h a p ro v isio n ; (3 ) w h e th e r th is p ro v isio n pre e m p ts pl ai nt i ffs ’ des i gn defe ctcl ai m s ; and ( 4) w hethert he D i s t r i ct C o u rt ’s d e c is io n is c o n s is te n t w ith th is a n a lysis

. A.
Par tB of t he V acc i ne A ct es t abl i s hes t he ci r cumst ance s underw hi ch i ndi vi dual s w ho have r ej ect ed the j udgm entof the V acc i ne C our tm ays ubs equent l yfi l e s ui ti n s t ate o rfede r al c o u rt
. S e c tio n 3 0 0 a a -2 2 , e n title d “ S ta n d a rd s o f R e s p o n s ib ility,” s et s for t h bot h a gener al rul e and s ever al exce pt i ons t o t hatrul e. Itst at es:19 (a ) G e n e ra l ru le E xceptas pr ovi ded i n s ubs ect i ons ( b) , ( c) , and ( e) o f th is s e c tio n S tate law sh a ll ap p ly to a c iv il act i on br oughtfordamages fora vac ci ne- r el at ed i nj ur yordeath. ( b) U navoi dabl e adve r s e s i de ef fec t s ; w arni ngs ( 1) N o vacc i ne manufactur ers hal l be l iabl e i n a ci vi l act i on fordamages ar i s i ng from a vacci ner el a t e d i n

j u r yo rd e a t h a s s o c i a t e d wi t h t he admi ni s t r at i on of a vacc i ne aft erO ct ober1, 1988, if th e in ju ryo r d e a th re su lted f ro m sid e e f

f e c ts t hatw er e unavoi dabl e eve n t hough t he vac ci ne w as pr oper l ypr epar ed and w as acc om pani ed by proper dir ect i on s and w arni ng s. (2 ) F o r p u rp o se s o f p a ra g ra p h (1 ), a v a c c in e sh a ll be pr es um ed t o b e accom pani ed bypr oper d ir ec ti o n s an d w ar ni ngs i f t he vac ci ne m a n u f a c tu re r sh o w s th a t it c o m p lied in a ll m at er i al r es pect s w i t h al l r equi r ement s undert he Feder al Food, D rug, and C os m et i c A ct[21 U

. S. C

. A

. § 301 et

s eq . ] and sect i on 26 2 o f th is t i t l e (i n cl udi ng r egul at i ons i s s ued unders uch pr ovi s i ons ) appl i cabl e t o the vac ci ne and r el at ed t o vacc i ne- r el at ed inj ur yordeath forw hi ch the ci vi l act i on w as b rou ghtunl es s t he pl ai nt i ff show s— ( A ) t hatt he manufactur erengage d in th e c o n d u c t se t f o rth in s ubpar agr aph ( A ) or ( B ) of s ect i on 300aa- 23( d) ( 2) of thi s t i t l e, or20 ( B ) bycl earand convi nci ng evi dence t hatt he manufactur er fa il ed t o ex erc ise d u e c are not w i t h s t andi ng i t s compl i ance w i t h s uch A ctand s ect i on ( and r egul at i ons i s s ued unders uch p rov isi o n s). ( c) D i r ectw arni ngs N o v a c c in e m a n u f

a c tu re r sh a ll b e liab le in a c iv il act i on fordamages ar i s i ng fr om a vac ci ne- r el at ed i nj ur y or death as s oci at ed w i t h t he admi ni s t r at i on o f a v a c c in e a f

ter O c to b e r 1 , 1 9 8 8 , so lelyd u e to t he manufactur er ’ s fai lur e t o pr ovi de di r ect w arni ngs t o t he i nj ur ed part y( ort he i nj ur ed par t y ’ s l egal r epr es ent at i ve) of the pot ent i al danger s r es ul t i ng fr om t he admi ni s t r at i on of the v ac cine m an u fa cture d b ythe m an u fa cture r. ( d) C ons t ruct i on T h e sta n d a rd s o f

re sp o n sib ili typ re sc rib e d b yth is s ect i on ar e nott o be cons t rued as author i zi ng a per s on w ho br oughta ci vi l act i on ford am ages agai ns ta vac ci ne manufactur erfo r a vacc i nerelated injuryo r de ath i n w h ich d am ag es w ere d e n ied o r w h ich w a s d ism iss e d w ith p re ju d ice to br i ng a new ci vi l act i on agai ns ts u ch manufactur er fors uch i nj ur yordeath. ( e) Pr eempt i on N o St a t e ma ye s t a b l i s h o re n f o r c e a l a w w h i ch21 p ro h ib its a n in d iv id u a l f ro m b rin g in g a c iv il act i on agai ns ta vaccine m anufa ctur erfor d a m a g e s f

o r a v a c c in e -re late d in

ju r y o r d e a th if su c h c iv il ac tio n is n o t b a rre d b yth is p a rt. 4 2 U .S .C . § 3 0 0 a a -2 2

. W e ar e gui ded byt w o cas es i nt erpr et i ng l anguage s i m i l ar t o t hat w hi ch appear s i n § 300aa- 22. I n Lori l l ar d Tobacco C o. , t he Supr eme C our ti nt erpr et ed the Feder al C i gar et t e Lab eli ng and A dver t i s i ng A ct , w hi ch st at ed t hat “‘ [n] o s t at ement r el at i ng t o s m oki ng and hea l t h ot h er than the s t at ement r equi r ed by se c tio n 1 3 3 3 o f

th is titl e , sh a ll b e re q u ire d o n a n yc ig a re tte p a c k a g e .’” 5 3 3 U .S

. a t 5 4 1 (q u o tin g 1 5 U .S .C . § 1 3 3 4 ). T h is lan g u a ge is a n a lo g o u s to su b se c tio n 2 2 (b )(1 ) o f th e V a c c in e A c t, w h ich sta tes th a t “ [ n ]o v a c c in e m a n u f a c tu re r sh a ll b e liab le in a c ivil ac ti o n fo r da m ag es a ri sing fro m a v ac cine -relat ed injury ordeath .

. . i f t he i nj ur y or death r es ul t ed fr om s i de eff ect s t hat w er e unavoi dabl e. ” 

### I n both pr ovi s i ons , wi thout us i ng l angua ge su chas “n o state sh all” o r “state law i s p reem p ted ,” C o n g ress h as set f o rthanarea inw h ichstate lawm ay n o t o p erate. I n CSX Trans por t at i on, I

nc. , t he Sup r e me Cou rtc o n s trued the fol l ow i ng p ro v is io n : “ A s ta te m a ya d o p t o r c o n tin u e in f o rc e a n y la w . . . unt i l s uch t i m e as t he Secr et aryhas adopt ed a rul e . . . cover i ng t he s ubj ectm at t erof such St at e re qui r ement
. A s t at e mayadopt o r c o n tin u e in f

o rc e a n a d d itio n a l o r m o re s tr in g e n t la w . . . w hen noti ncompat i bl e w i t h anyFeder al l aw . . . . ” 507 U

. S. at 6 6 2 & n . 2 ( q u o t i n g 4 5 U

. S

. C

. § 4 3 4 ( r e p e a l e d 1 9 9 4 ) )

. S i m i l a r l y, S e c tio n 2 2 ( a ) o f th e V a c c in e A c t es tab lish e s a g e n e ra l ru le per m i t t i ng s t at es t o r egul at e vac ci nes s ubj ectt o s ever al e x c e p tio n s s e t f

o rt h in s u b s e c tio n s (b ), ( c ), a n d (e ).22 I n bot h Lori l l ar d Tobacco C o. and CSX Trans por t at i on, I nc. , t he Supr eme C our tcharac t er i zed the l anguage ati s s ue as an ex p ress p ree m p ti o n p rov isi o n . In th e f o rm er ca se, th e C o u rt decl ar ed that“C ongr es s u n equi vocal l ypr ecl ude[d] t he r equi r ement of any addi t i onal s t at ement s on ci gar et t e pac kages bey ond t hos e provi ded i n § 1333. ” L ori l l ard Tobacco C o. , 533 U

. S. at542. I n t he l at t ercas e, t he C o ur tchar act er i zed the quot ed l anguage as cont ai ni ng “expr es s s avi ng and pr eempt i on cl aus es . ” CSX

Trans p. , I nc. , 5 0 5 U. S

. a t6 6 2

. Ac c o r d i n g l y , we c on c l ud e t ha t § 22 ( a ) a nd § 22 ( b) ( 1) of t he V a c c i ne A c t al so c o n ta in e x p re s s p re e m p tio n c la u s e s . O urconcl us i on i s cons i s t entw i t h pr i orj ur i s prudence fr om t hi s C our t , s tat ing thatexpr es s pr eempt i on “ar i s es w hen t her e i s an expl i ci ts t atut or ycomm and thats t at e l aw be di s pl ace d. ” St

. Thom as - St

. John H ot el & Tour is m A s s ’ n, I

nc. v. G o v’t of th e U

. S

. , V

. I. , 2 1 8 F .3 d 2 3 2 , 2 3 8 (3d C ir

. 2 0 0 0 ). S e c tio n 2 2 ( a ) c lea rlysta tes C o n g re ss ’s in ten t to d isp lac e sta te l aw i n s ever al enumer at ed i ns t ance s , i ncl udi ng as pr ovi ded for i n s ub s ect i on ( b)

. Subse ct i on ( b) t hen dec l ar es t hat m anufa ctur er s ar e i m m une fr om l i abi l i t yforcl ai m s ar i s i ng fr om “unavoi dabl e” i nj ur i es and dea t hs r el at ed t o vacc i ne a d m in istra tio n , the re b yp ro h ib iti n g sta tes f ro m re g u latin g in th is a re a . T h e sc o p e o f a p re e m p tio n p ro v isio n sta tin g th a t “n o sta te s hal l pas s l aw s w i t h t he fol l ow i ng exce pt i ons ” mayw el l be br o ad ert han a pr ovi s i on s t at i ng “s t at e l aw appl i es w i t h t he fol l ow i ng exce pt i ons . ” Y ett he br eadth of a pr ovi s i on does not al t ert he i m por tof the under l y i ng l anguage, and her e that l anguage convey s a cl eari nt entt o overr i de s t at e l aw ci vi l act i on c la im s in p a rt ic u la r, d e f in e d c ir c u m s ta n c e s .23 Y etw e musts t i l l d eterm i ne the s cope a nd r eac h of the expr es s pr eempt i on pr ovi s i on. T he pl ai nt i ffs her e conc ede that t h e s t a tu t e “ e xp r e s s l yp r e c l u d e s o n l yt h o s e s t a t e t o r tc l a i ms i nvol vi ng vacc i nes w i t h side ef fec t s fi r s ts how n t o be
‘ unavoi dabl e, ’ ” butt heyar gue thatavoida b il i t ym us tfi r s tbe det er m i ned “on a ca s e- by

- bas i s ” as par tof a c our t ’ s exami nat i on o f a d e sig n d e f

e c t cla im . In re sp o n se , W y e th a r g u e s th a t th is l anguage “pr eempt s al l cl ai m s ar i s i ng fr om al l egat i ons of des i gn d e f e c t.” A c c o rd in g ly , “w e m u st [ ] ‘id e n tifyth e d o m a in e x p re ss ly p re -e m p ted ’ by [ th e ] l a n g u a g e ” o f th e V a c c in e A c t. Medtr oni c I

nc. , 5 1 8 U .S . a t 4 8 4

.

B. A gai n, w e ar e mi ndful that cour t s s eeki ng t o i dent i fyt he sc o p e o f a n e x p re ss p re e m p tio n p r o v is io n a re c o m p e lled to cons i der“C ongr es s i onal purpos e [] t he ‘ul t i m at e t ouchs t one’ of ouri nqui r y . ” Lori l l ar d Tobacco C o. , 533 U

. S. at541 ( quot i ng C i poll o ne v. Ligget tG r oup, I nc. , 5 0 5 U

. S

. 5 0 4 , 5 1 6 (19 9 2 )). T he Supr eme C our thas decl ar ed o n n u m er ous occa s i ons t hat re v iew in g c o u rts h a v e s e v e ra l to o ls to a id th e m in th e ir i nt erpr et at i on of congr es s i onal purpos e. C our t s m aybe gui ded byt he “ str u cture and purpos e of the s t atut e as a w hol e, as rev ea led n o t o n ly in the tex t, b u t th rou g h the re v iew ing co u rt ’s r eas oned under s t andi ng of the w ay i n w hi ch C ongr es s i nt ended t he s t atut e and i t s s ur r oundi ng r egul at or ys cheme t o aff ect bus i nes s , cons um er s , and the l aw . ” Medtr oni c, I nc. , 518 U

. S. at 4 8 6 ( 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 ); see al so G ade , 50 5 U

. S

. at98 ( “O urul t i m at e t as k i n anypr e- empt i on c a se is to d e ter m in e w h e th e r sta te re g u latio n is c o n sis ten t w ith the s tru cture an d p u rpo se o f th e statute a s a w h o le. ”);24 Ingers ol l

- R and C o. v. McC l endon , 4 9 8 U. S. 1 3 3 , 1 3 8 ( 1990) (“T o d iscern C o n g ress’ inten t w e ex am ine the e x p li citstatu tory l anguage and the s t ructur e and purpos e of the s t atut e. ”)

. B ey ond stru ctu re a n d p u rpo se, th e C o u rth as a lso stated “tha t ‘ [i]n e x p o u n d in g a sta tu te, w e m u st n o t b e g u id e d b y a sin g le s ent ence orm ember of a s ent ence , butl ook t o t he pr ovi s i ons of t he w hol e l aw , and t o i t s obj ectand pol i cy . ’ ” P i l otLi f e I ns . C o. v. D edeaux , 481 U

. S. 41, 51 ( 1987) ( quot i ng Kel l y v. R obi ns on , 4 7 9 U .S . 3 6 , 4 3 (1 9 8 6 ). T h e a b o v e a n aly sis, all o w ing co u rt s to c o n side r a s t atut e’ s p u rpos e, s t ructur e, and r egul at or ys cheme, appl i es even in li g h t of

the p re s u m p tio n ag ains t pree m p ti o n . T h e C o u rt ’s pr eempt i on di s cus s i on i n C i pol l one i s par t i cul ar l yi ns t ruct i ve on t hi s p o i nt
. I n t hatcas e, t he C our tcons i der ed a s t atut e s t at i ng t hat“[n] o s t at ement r el at i ng t o s m oki ng and h ea lth s hal l be re q u ir e d in th e a d v e rt is i n g o f [ p ro p e rl yla b e le d ] c ig a re tte s .” C i pol l one , 5 0 5 U .S . at 5 1 8 (in ter n a l q u o tatio n s a n d e m p h a sis om i t t ed). T he C ou rtre a f f i rm ed the presum pti on against p re e m p tio n . I

d. at 51 6. It al so no t ed the exis t ence o f an e xp res s p re e m p tio n c la u s e , i d. at 517, w hi ch i tcons t rued us i ng s ever al to o ls o f s ta tu to ry c o n s tru c tio n , id

. at 519. T he C our tnot ed the A c t’s e x p licit “ sta tem e n t o f p u rp o se ,” a n d it rea d th is a g a in st a “bac kdr op of r egul at or yact i v it y . ” Id

. I tal s o cons i der ed the “r egul at or y cont ext , ” namel y t he fac t or s t hat s er ved as “t he c a ta lyst f o r th e p a s s a g e ” o f

th e s ta tu te
. I

d. T he C our ts t at ed that t hi s backdr op and cont ext s uppor t ed a narr ow r eading o f t he p re e m p t io n c la u s e . I

d. a t 5 1 8

– 1 9 . In d iss e n t, Ju stic e S c a lia cr i t i ci zed the maj or i t y and ar gued for a br oaderi nt erpr et at i on of t he pr ovi s i on, pr edi cat ed on t he s t atut e’ s us e of the phr as e “no s t at ement
. ” I

d. a t 5 4 9

– 5 0 (S c a lia, J., d iss e n tin g ). T h e m a jo rity25 re jec ted Ju stic e S c a lia’s in ter p re tatio n b e c a u se it “ re lie[ d ] so lely on an i nt erpr et at i on of t hos e t w o w or ds , ar t i fi ci al l ys ever ed fr om bot h t extual and l egi s l at i ve cont ext
. ” I d. a t 5 1 9 n .1 6

. W e have r ecogni zed thatl egi s l at i ve hi s t or y i s notw i t hout its sh o rtc o m in g s a s a to o l o f in ter p re tatio n . “ A s a p o in t o f f a c t, t her e ca n be mul t i pl e l egi s l at i ve i nt ent s beca us e hundr eds of m e n a n d w o m e n m u st v o te in f a v o r o f a b ill in o r d e r f

o r it to become a l aw . ” Mor

gan v. G ay , 466 F. 3d 276, 278 (3d C ir

. 2 0 0 6 ); see al

so Exx o n Mo b i l Cor

p . v . Al l a

p a t t a h S e r v s . , I

nc. , 5 4 5 U .S . 5 4 6 , 5 6 8 (2 0 0 5 ) (n o tin g th a t “le g isla tiv e h isto ryis itse lf o f ten m u rk y , am b ig u o u s, a n d c o n tra d icto ry ,” a n d th a t it
“ m a yg iv e u n re p re se n tativ e com m i tt ee m em be rs— o r, w o rse y e t, unel ect ed s t aff

er s and l obby i s t s

— bot h t he p o w er and t he i ncent i ve t o . . . s ecur e r es ul t s t heyw er e unabl e t o achi eve th ro u g h th e sta tu to ry tex t”)

. Y e t, res o rt to leg isla tiv e h isto ryis ap p rop ri ate “w h en n ec essa ry to i n terpret am b igu o u s statutory t ext
. ” B edRoc Lt d. , LLCv. U ni t ed Stat es , 5 4 1 U .S

. 1 7 6 , 1 8 7 n .8 (2 0 0 4 ) (p lu ra lityo p in io n ). A lth o u g h th is C o u rt h a s d e c lin e d to e mp l o y l e g i s l a t i v e h i s t o r yi f a s t a tu t e i s c l e a ro n i t s f a c e , we have a l l ow ed r ecour s e t o l egi s l at i ve hi s t or yi n the fa ce of a m b ig u ity. See, e. g. , In re Me h ta , 3 1 0 F

. 3 d 3 0 8 , 3 1 1 (3d C ir

. 2002) ( “W e l ook t o t he t ext of a s t at u te t o d et er m i ne congr es s i onal i nt ent , and l ook t o l egi s l at i ve hi s t or y onl y i f t he tex t is a m b ig u o u s.” ); U

ni t ed St at es v. G r egg , 226 F. 3d 253, 257 (3 d C ir. 2 0 0 0 ) (“ T o d e ter m in e a law ’s p lain m e a n in g , w e b e g in w ith th e lan g u a g e o f th e sta tu te. If th e lan g u a g e o f th e s ta tu te ex p resse s C o n g ress’s i nt entw i th s uffi ci en t prec isi o n , the in q u iry end s there .

. . W here t he st atutory l a ng uag e do es not express C o n g re s s ’s in ten t u n e q u iv o c a lly , a c o u rt tra d iti o n a llyre f e rs to th e le g is la tiv e h is to ry . . . .” ).26 Itis, there fo re, a p p rop ri ate to c o n side r l eg isl ati v e h ist o ry t o r es ol ve ambi gui t y in t he s cope of an expr es s pr eempt i on pr ovi s i on. I n C i

pol l one , as par t o f the di s cus s i on of the r e g u l a t o r yc o n t e x to f

t h e s t a tu t e a ti s s u e , t h e Cou r tci t ed l anguage fr om a H ous e of Repr es ent at i ves ’ r epor tt h atw as i s s ued dur ing C ongr es s ’ s cons i der at i on of the l egi s l at i on. C i pol l one , 505 U

. S. at519. Si m i l ar l y , i n L ori l l ard Tobacco C o. , th e C o u rt sta ted th a t it s ta sk w a s to “ id e n tifyth e d o m a in expr es s l ypr e- empt ed, ” 533 U

. S. at 541, and thatt hi s w as ai ded “by cons i der i ng t he pr edec es s or pr e- empt i on pr ovi s i on and the ci r cumst ance s i n w hi ch t he curr ent l anguage w as adopt ed. ” I d. at542. I t w ent on t o ci t e re por t s fr om t he U ni t ed St at es Sur geon G ener al , t he H ous e o f R epr es ent at i ves , and the Senat e i n t he c o u rs e o f its d is c u s s io n . I

d. a t 5 4 2

– 4 4

. W e cannot r es ol ve fr om s t atut or yt extal one the s cope of t h e e x p r e s s p r e e mp t i o n p r o v i s i o n b e f o r e u s . Ac c o r d i n g l y , we w i l l l ook att he l anguage , s t ructur e, and purpos e of t he V acc i ne A ctt o ascert ai n w hetheri tpreem p ts al l desi gn defe ctcl ai m s, and w e w i l l r es or t

— as w e m us t

— t o l egi s l at i ve hi s t or yt o ai d our i nt erpr et at i on. C. W e ar e l eftt o cons t rue the s cope of pr eempt i on cr eat ed b yth e p h r a s e “ if

th e in ju ryo r d e a th re su lted f ro m sid e e f

f e c ts t hatw er e unavoi dabl e . . . . ” § 300aa- 22( b)

. T he phr as e hi nges on t he w or d “unavoi dabl e, ” y ett he t er m is not defi ned i n the V acc i ne A ct
. N ordoes t he s ur r oundi n g lang uage a ns w er q u e s tio n s su ch as w h ethe r all d esig n d ef ec t cl aim s are pr eempt ed orw hethers t at e court s m aydet e rmi n e a v o i d a b i l i t yon27 a ca s e- by

- cas e bas i s . A ccor di ng t o t he O xf ord E ng l ish D i ct i on ary , “unavoi dabl e” m eans “[n] otavoi dabl e; t hat[w hi ch] c a n n o tb e a v o i d e d o re s c a p e d ; i n e v i t a b l e . ” ( 2 d e d

. 1 9 8 9 )

. By i t s el f, t hi s s ucci nctdefi ni t i on i s unhel pful

. Y et , t he s t ructur e of t he pr ovi s i on as a w hol e pr ovi des nece s s arycont ext , and w e ca n c o n c e iv e o f

tw o p o s s ib le in te rp re ta tio n s o f th is la n g u a g e . 1 . T he fi r s tcons t ruct i on w oul d r es ul t i n t he pr eempt i on of so m e d e sig n d e f

e c t cla im s. S u b se c tio n (a ) e x p re ss lyp re e m p ts s t at e l aw t o t he degr ee i ndi cat ed i n s ubs ect i on ( b)

. Subse ct i on ( b) , i n tur n, pr i m ar i l yrelat es t o des i gn defe ctcl ai m s , as evi dence d byt he us e of a s ubor di nat e cl aus e i n tr o d uced by
“ e v e n t h o u g h ” t o r e fe r e nc e c l a i ms t h a tmi g h ta r i s e f r o m a m anufa ctur i ng defe ctorw arni ng defe ct
. T hats t ructur e makes i tcl eart hatw e mustcons i der des i gn defe ct s i n t he fi r s ti ns t ance . C l ear l y , t hen, s ubs ect i on ( a) and (b) w or k i n conce r tt o pr eempt s t a t e l a w a n d e x e mp t ma n u f a c tu r e r s f

r o m l i a b i l i t y fo r s o me d e s ig n d e f

e c t c la im s . Sect i on 300aa–22, t aken a s a w hol e, fur t hercl ar i fi es C on gress ’s i ntentw i t h regard t o d esi gn defe ctcl ai m s. Subse ct i on ( a) di s pl ace s s t at e l aw onl y as defi ned i n s ubs ect i ons ( b ) , ( c ) , a n d ( e )

. Su b s e c t i o n s ( b ) a n d ( c ) e mpl o yi dent i cal i nt r oduct or y l anguage , s t at i ng t hat “[n] o vacc i ne manufactur er s h a l l b e l i a b l e i n a c i v i l a c t i o n f o rd a ma g e s a r i s i n g f

r o m a vacc i ne- r el at ed i nj ur y or deat h as s o c i a t ed w i t h t he admi ni s t r at i on of a vacc i ne . . . . ” Subs ect i on ( e) pr ohi bi t s s t at es fr om for ecl os i ng ci vi l act i ons t hatar e otherw i s e “notbarr ed by this pa rt , ” the re b y stat ing that o ther p arts of § 3 0 0 aa -22 are28 d e s i g n e d t o n o to n l y l i m i tl i a b i l i t y b u tb a rs o m e c l a i m s e n t i r e l y. T hus , byr eadi ng t hes e thr ee pr ovi s i ons t ogether , itbecomes c lea r th a t C o n g re ss in ten d e d th a t su b se c tio n s (b ) an d (c ) sh o u ld b e a n o u tr ig h t b a r t o s o m e c la im s . 

### Ina case p resen tin g d esig n d ef ect claim s similar to th o se i n the pr e s e nt

c a s e , the Ge or gi aSupr e m e Court r e a c he d a di ff e r e nt c on c lus i onr e gar di ngthem eaning of § 

### 2 2 (b ). Am

. H o m e Pro d s. Co rp v. F

erra ri , 6 6 9 S .E .2 d 2 3 6 (G a . 2 0 0 8 ). It foc us e d on the c l aus e “ i f the i njury or de ath r e s ul t e d fr om

s i de ef f ects th at w ere un av o id ab le.” T h at C o urt f irst n o tedth at th is lang uag e is cond itional andim plie s that s om e vac ci ne-r el at ed in j uries an d d e ath s may

b e av o id ed

. I

d. at 24 0. Th e F

erra ri C o urt also reaso n edth at re ad in g th e p reem p tio np ro v isio nto ex clu d e all d esig nd ef

ect claim s w o u ld ren d er th e clau se sup erf lu o u s. I d. at 2 4 0 . T h at C o urt co n clu d edth at if C o n g ress i nt e nde d to pr e e m

pt a l lde s i gn de fe c t

c l a i m s , i t

c oul d have ac hieved that

re sult by om itti ng the “un avoidable” cl ause such that the provisi onwo uld p re vent li abil it y “i f the vaccine was pr operl y pr e par e d and wa s a c c om pani e d by pr ope r di r e c t i ons and w ar ning s. ” I d. We do no t consid erth e F erra riCourt ’ s r e a di ng t o be co m p ellin g . F irst, w h i l e w e reco g n ize th at th e lan g u ag e is c ondi t i ona l , s uc h ar e a di ng doe s not for e c l os e the pr e e m

pt i on o f so m e claim s. Fur t her m or e, i t i s al w ay s pos s i bl e t o cons t ruct th ro u g h h in d sig h t an a ltern a te s tru c tu re f o r a st a tu te w ith al t ernat i ve w or di ng t hatw oul d ren deri tm or e cl ear . For i ns t ance , s ubpar t( b) ( 1) no tes thatm anufa ctur er s m aynotbe l i abl e for unavoi dabl e si de effec t s caus ed bya vac ci ne thatw as “pr oper l ypr epar ed and w as accom pani ed bypr operdi r ect i ons

### Se e, e . g. , Da vi s v . W ye th La bs., Inc. , 399 F. 2d 121, 128 7 

### (9 thC ir. 1 9 6 8 ); Lewis v . Baker , 413 P. 2d 400, 404 ( Or

. 1966) (o v erru ledinp art o no th er g ro un d s). 29 an d w arn ing s, ” a n d su b p art (b)(2) se ts li m it s o n this. In su b p art 22( b) ( 2) , t he s t atut e dec l ar es t hat vacc i nes i s s ued i n acc or dance w i t h fede r al l abel i ng r equi r ement s ar e pr es um ed t o have pr oper dir ect i on s and w arni ng s un l ess one of the fol l ow i ng appl i es : ( 1) th e m a n u f

a c tu re r e n g a g e d in c o n d u c t th a t w o u ld su b jec t itto puni t i ve damages under § 3 0 0 aa- 23 of the V acc i ne A ct , or( 2) t her e i s cl earand convi nci ng evi dence t hatt he manufactur er fai l ed t o exer ci s e due c ar e. § 3 0 0 aa - 22( b) ( 2)

. I f, as pl ai nt i ffs claim , C o n g ress inten d ed to ca rve o u t from su b sec tio n 2 2 (b) a m e c h a n ism to e n a b le sta tes to d e ter m in e w h a t sid e e f f e c ts c o u ld h a v e b e e n a v o id e d th ro u g h a n a ltern a te d e sig n , C o n g re ss c o u ld have don e so in the mannerus ed i n s ubpar t( b) ( 2) t o pr es er ve s om e w arni ng defe ctcl ai m s agai ns tvacc i nes t hatm eetfede r al la b e lin g re q u ir e m e n ts
. 

### Mo re im p o rtantly , we thinkthe F erra riCo urt’ s co n stru ctio nis c o n trary

to th e stru cture o f

th e A ct b ecau se it d o es n o t b ar any

d e s i g nd ef

ect claim s. I f w e i nt erpr ett he V acc i ne Actt o a l l ow cas e- by

- cas e ana l y s i s of w hetherpar t i cul ar v a c c in e sid e e f

f e c ts are a v o id a b le, e v e ryd e sig n d e f e c t cla im is s ubj ectt o eval uat i on b y a co u r t
. Fur t her m or e, i n 1986 w hen C ongr es s enac t ed the V acc i ne A ct, s ever al cour t s had al r eady barr ed s t r i ctl i abi l i t ydes i gn defe ctcl ai m s agai ns tp r es cr i pt i on drug m anufa ctur er s unders t at e l aw . T he FerrariC o u rt ’s 7 c o n s t ru c t i o n o f

§ 3 0 0 a a - 2 2 c o u l d c r e a t e a n a wk wa r d d i c h o t o my i n t he c a s e l a w of

t h e s e s t a t e s

— th e i rc o u r t s wou l d b e r e q u i r edI n W yeth v. Levi ne , S

. C t
. , N o . 0 6

- 1 2 4 9 , 2 0 0 9 WL 8 529172, at*1 ( 2009) , t he Supr eme C our texami ned w hether fede r al l aw pr eempt ed s t at e t or tcl ai m s al l egi n g that a drug m an u fa cture r fa il ed to ad eq u atelyw arn o f th e d an g ers a s s o c ia te d w ith a d ru g . I d. at*1. T hough w e r ecogni ze thatt he Supr eme C our tconcl uded thats t ate tort l aw cl ai m s w er e not p re e m p te d in th a t c a s e , i d. at13 , L evine i s r eadil y d istin g u ish a b le o n se v e ra l g ro u n d s. F irst, th e C o u rt e x p licitly not ed the abs ence of an e xpr es s pr eempt i on pr ovi s i on and found C ongr es s ’ s s i l ence , “coupl ed w i t h i t s cert ai n aw ar enes s of the pr eval ence of s t at e t or tl i t i gat i on, [] pow er ful evi dence

. ” I d. at 10

. In t his case, ho w ever, C on gress i ncluded an ex press pr eempt i on pr ovi s i on t hatw as pr om pt ed, as evi dence d byt he C om m i t t ee Repor t , byt he pr eval ence of st ate t or tl i t i gat i on. Second, i tr ecogni zed that , underfede r al l aw , a drug m anufa cture rcoul d s t r engthen a drug' s l abel w i t hout p re a p p ro v a l f

ro m th e F D A

. I

d. a t 7 . T h is s tan d s in c o n tra st to t he FD A ’ s far

- m or e ext ens i ve contr ol and over s i ghtof the 30 t o engage i n cas e- by

- case anal y s i s of al l s t r i ctl i abi l i t yand n e g lig e n t d e sig n d e f

e c t c laim s b ro u g h t u n d e r th e V a c c in e A c t, w hil e barr i ng stri ctl i abil i t ydesi gn defe ct c lai m s agai nst prescr i pti on drug m anu fact urer s. A s di scussed abo ve, C on gress coul d nothave i nt ended s uch a r es ul t , as § 300aa- 22 m akes cl ear th a t C o n g re s s in te n d e d to p re e m p t a n d b a r c e rt a in c la im s . T hough t her e ar e tw o pos s i bl e i nt erpr et ati o ns of su b se c ti o n (b ), w e c o n c lu d e th a t a “ c lea r a n d m a n if e st” expr e s s i on of

c on gr e s s i on a l i nt e nts up po r t s t he fi rs t in ter p re tatio n . O u r c o n stru c tio n , h o w e v e r, d o e s n o t in d ica te 8a p p ro v a l o f a d ru g ’s d e s ig n a n d a lte ra tio n .

31 w h e th e r su b se c tio n (b ) p re e m p ts a ll d e sig n d e f e c t cla im s o r o n ly s tr ic t lia b ility d e s ig n d e f e c t c la im s . 2. T her e i s no l anguage i n t he st atut e i ndi cat i ng w hethert he Va c c i n e Ac t p r e e mp t s o n l y s t r i c t l i a b i l i t y d e s i g n d e f e c t c l a i ms or al so tho se based in negli gen ce, and t he st ructure and pu rpose o f t h e Ac t a r e o f l i t t l e a s s i s t a n c e i n r e s o l v i n g t h a tq u e s t i o n . As a r es ul t , t her e r emai ns s om e i nher entambi gui t yi n t he s t atut e, and w e mustr es or t to l egi s l at i ve hi s t or yt o r es ol ve that ambi gui t y . T he part ies in thi s cas e ci t e t o di ffe r ent congr es s i on al repor t s t o s uppor tt hei rcl ai m s . E ach a r gum ent w i l l be addr es s ed i n tur n.

a . W y eth ci t es t o a r epor t( “C om m er ce Repor t ”) fr om t he H ous e C om m i t t ee on E ner gyand C om m er ce ( “Ener gyand C om m er ce C om m i t t ee” ) , w hi ch had j ur i s di ct i on overt he Vac c i n e Ac ta n d g u i d e d t h e l e g i s l a t i o n t h r o u g h p a s s a g e . H. R. R ep. N o. 99- 108 ( 1986)

. T he C o m m erce Repor tdecl ar ed that c h ild h o o d v a c c in a tio n s h a v e been “on e of th e m o st s p e c tac u lar ly eff ect i ve publ i c hea l t h i ni t i at i ves thi s countr yhas ever under t aken, ” pr event i ng count l es s deaths and s avi ng bi l l i ons of d o lla rs . I d. at 4. T h e R ep o rtstat ed , h o w ev er, th at “the N ati o n ’s abi l i t yt o m ai nt ai n t hi s l evel of s ucce s s has come i nt o ques t i on” as a r es ul tof t or tclai m s byi ndi vi dual s gr avel yi nj ur ed by32 v ac cine s . I

d. T hi s , i n tur n, caus ed an i ncr eas e i n t he cos tof vacc i nes , t he w i t hdr aw al of s om e manufactur er s fro m t he m a rk e t, a n d a d e c re a s e d ra te o f im m u n iz a tio n . I

d. T h e R ep o rt not ed thatt hes e condi t i ons pr om pt ed the Ener gyand C om m er ce C o m m itte e to re e v a lu a te th e f e d e ra l r e g u la tio n o f

v a c c in e s . I

d. a t 5

. T h o u g h th e C o m m itt e e w a s c o n c e rn e d w ith c o m p e n sa tin g in d iv id u a ls in ju re d b y v a c c in e s, it a lso so u g h t to r educe t he cos t o f su ch cl ai m s i n or dert o s afe guar d t he d ev elopm entand ava i l abi l i t yof s uch vac ci nes . I tnot ed that t her e w as “ n o ‘ per fec t ’ orr eac t i on- fr ee c hi l dhood vacc i ne on the m ar ket ” and thata sm al l num berof chi l dr en s uffe r ed s er i ous re a c tio n s . I

d. at 6. I tt hen s t at ed that“des pi t e thes e pos s i bi l i t i es

. . . itis s a f

e r to tak e th e re q u ire d sh o ts th a n to risk th e h e a lth cons equenc es of contr act i ng t he di s eas es . . . . ” I d. T he C om m i t t ee e xpr es s ed conc ern tha tt he “w i t hdr aw al of eve n a s i ngl e manufactur erw oul d pr ese n t the veryr eal pos s i bi l i t yof v acc i ne s hor t ages , and, i n tur n, i ncr eas i ng num ber s of uni m m uni zed c hi l dr en, and, perhaps , a resu r gence of pr event abl e di s eas es . ” I d. at 7. T he R epor tdemonst r at es t hatt he V ac cine A ct w as m o ti v ated in g rea t m ea s u re b yC o n g ress’s bel i ef thatan al t ernat e compens at i on s y s t em w oul d r educe aw ar ds and cr eat e a s t abl e, pr edi ct abl e bas i s fo r est i m at i ng liab ili ty : “[ T ]h e C o m m itt e e b e liev e s th a t o n c e th is s y ste m is in pl a c e a n d ma n u f

a c tu r e r s h a v e a b e t t e rs e n s e o f t h e i rp o t e n t i al l i ti g at i on obl i gat i ons , a more s t abl e chi l dhood vacc i ne mar ket w i l l evol ve. ” I

d. I mpo rt a n t l y , th e Comme r c e Re p o rts p e ci fi cal l yaddr es s ed § 3 0 0 a a - 2 2 , t h e s e c t i o n a ti s s u e h e r e . Fi r s t , i tn o t e d t h a ts o meT he G eor gi a Supr eme Court t ook t hi s r efe r ence t o m ean 9 t h a tC o n g r e s s i n t e n d e d t o p r e s e r v e s o m e d e s i g n d e f e c tc l a i ms a n d p e r m it ca se -b y -c a se c o n sid e ra tio n o f w h e th e r a v a c c in e is u n a v o id a b ly h a rm f

u l. See Ferrari , 668 S. E

. 2d at23 9

– 4 0. Speci fi cal l y , t he FerrariC o u rt p o in ted to th e f a c t th a t a m a

jo rity o f c o u r t s h a v e i n t e rp r e t e d c o m m e n tk a s p e r m i t t i n g a c a s e - b ycas e ana l y s i s of w hethera vac ci ne’ s s i de eff ect s ar e avoi dabl e. I d. at 23 9

. Itthen d rew o n the V ac cine A ct’s l eg isl ati v e h ist o ry to su p p o rt its c o n c lu sio n th a t C o n g re ss in te rp re ted c o m m e n t k in th e s a m e m a n n e r a s th o s e o th e r c o u rt s . I d. a t 2 4 0

. T h o u g h w e a c k n o w led g e th a t a m a jo rityo f sta tes p e rm it so m e d e sig n d e f

e c t c laim s u n d e r c o m m e n t k , w e d isa g re e w ith th e G e o rg ia S u p re m e C o u rt o n th e re lev a n c e o f th is f a c t. F irst, i t di s count s t hat cour t s i n a s i gni fi cant m i nor i t y of s t at es ha ve hel d t hatcomm entk pr eempt s al l s t r i ctl i abi l i t ydes i gn defe ct c laim s a g a in st F D A -a p p ro v e d d ru g s. S e c o n d , th e c u rre n t sta te of af fai r s w i t h r egar d t o t he i nt erpr et at i on of comm ent k t el l s us l i t t l e aboutw hatC ongress knew i n 1986 w hen i tpas s ed the V acc i ne A ct
. A s one courthas not ed, “i n 1986 cour t s had not y et r eac hed a c ons ens us on t he meani ng of C om m entk, ort he pr opert r eatm entof pr es cr i pt i on drugs i n des i gn defe ct l e g i s l a t i o n . T h u s , w h i l e s o m e c o u r t s c o n c l u d e d t h a t a c a s e - b ycas e ana l y s i s w as necessary. . . ot her s concl uded that 33 provis i on s of the V acci ne A ctw ou l d “ch ang e m ostS t at e l aw s” r el at ed t o vacc i ne i nj ur i es and dea t hs

. Y et , i t d ee m ed thi s an appro p ri at e cha nge “i n l i ghtof the ava i l abi l i t yof a compre hens i ve and f

ai rcompensa t i on s y s t em. ” I d. at25. T hen, t he C om m er ce Repor ts t at ed thatt he V acc i ne A ct r efl ect ed the p rin c ip le of R es t at ement ( Second) of Tort s § 402A comm entk, 9pr escr i pt i on drug m anufa ctur er s w er e gene r al l ynotl i abl e for d e s ig n d e f

e c t c la im s .” Mi l i trano v. L ederl e L ab s. 769 N

. Y

. S. 2d 8 3 9 , 8 4 4

– 4 5 (N

. Y

. S u p . C t. 2 0 0 3 ). 

### Finally , we note that r e gar dl e s s of s t at e c ourt

c ons i de r at i ono f c omm e nt k, we be l i e ve Co n g re ss m ade i t c le ar

wh at it inte nd ed wh en it

invo ked co mm ent k

. Comm e nt k s t at e s the fol l owi ng: 10 

### The r e ar e s om e pr oduc t s w h ic h, i n the pr e s e nt s t at e of hum an knowl e dge , ar e qui t e i nc a pabl e of being m ade s af

e f or thei r i ntended andordinary us e . . . . An out s t andi ng e xam pl e i s th e va c c i ne for th e Pa s t e ur

tr e atm e nt

of r abi e s , whi c h not unc omm onl y

l e a ds t o both s e ri ous and dam a gi ng c ons e que nc e s whe n i t

i s i nje c t e d. Si nc e the di s e a s ei t s e l f i nvari abl y

l e a ds t o a dr e a dfulde ath, bo th the m ar

keti ng and the use of the vaccine ar e f u lly j u stif ied , n o tw ith stan d in g th e un av o id ab le hi gh d eg ree of ri s k whi c h the y i nvol ve . Suc h a pr oduc t , pr ope r l y pr e par e d, and a c c om pani e d by prop er dire ctions and w ar

ning , i s not d efective, nor i s i t unr e a s onabl y

dange r ous . . . . The s e l l e r

of such pr o du ct s, agai n w it h the qu al ific ation that the y are pr ope r l y

pr e par e d and m arke t e d, and p ro p er w arn in g is g iv en , w h ere th e situ atio ncalls 34 w hich st at es t hat s el l ers of ce rt ai n p roducts , i ncludi ng vaccines, sh o u ld n o t b e stric tly liab le f o r ha rm c a u se d b y th e ir p ro d u c ts w hen i ti s notpos s i bl e t o m ake thes e produc t s ent i r el y s afe

. I d. 10

### for i t , i s not

t o b e he l d t o s tri c t

l i abi l i ty for un fo rt un at e c on se qu ence s att ending thei r use , m e r e l y be c aus e he ha s unde rtak e n t o s uppl y the p ub lic w ithanap p ar e ntly u sef u l an dd esirab le p ro du ct, att en d edw itha kn o w nb ut ap p aren tly reaso n ab le risk

. R estatem ent (S eco n d ) o f

T o rts § 

### 4 0 2 Acmt k(1 9 6 6 ). 35 a t 2 5

– 2 6 . T h e R e p o rt d e sc rib e d th e typ e o f v a c c in e c a se s in w hi ch comm ent k w oul d have i m por t

— cas es i n w hi ch i nnocent c h ild re n w o u ld b e “ b a d lyin ju re d o r k ill e d ” b y a v a c c in e , b u t in w hi ch a j ur yw oul d l i kel yi m pos e l i abi l i t y on t he manufactur er “e v en if th e d ef

en d an t m an u fa cture r m ay have made as s afe a vacc i ne as any one r eas onabl ycoul d expec t
. ” H

. R

. R ep. 99–908 a t 2 6 (e m p h a sis a d d e d ). F in a lly , itsta ted in p re c ise a n d c e rta in t er m s t hati t s r efe r ence t o comm entk and the l anguage of 22( b) r es ul t s i n i m m unit y fo r l i abi l i tyforal l des i gn defe ct s , w hether li abi l i t yr es t s on t heor i es of s t r i ctl i abi l i t yornegl i gence : “[i ]f [i nj ur ed i ndi vi dual s ] cannotdemonst r at e underappl i cabl e l aw ei t hert hat a vac ci ne w as i m pr oper l ypr epar ed ort hati tw as acc om pani ed by i m pr oper di r ect i ons or i nadequa t e w arn i ngs [ t h e y ] s h o u l d p u r s u e r e c o mp e n s e i n t he c omp e n s a t i o n s y s t e m, nott he t or ts y s t em. ” I

d. I n our vi ew , t he C om m er ce Repor ts uppor t s t he concl us i on t hatt he V acc i ne A ctpr eempt s al l des i gn defe ct cl ai m s , i ncl udi ng t hos e bas ed i n negl i gence . F ir st, t he C om m i t t ee Repor tr epea t edl ys t r es s ed th e i mpo rt a n ce of vacc i ne devel opm entand ava i l abi l i t y . Second, i texpr essed s er i ous36 conce r n overt he w i t hdr aw al of eve n a s i ngl e vac ci ne m anufa ctur erfr om t he mar ketpl ace . T hi r d, though i tdes cr i bed a r egi m e thats oughtt o compensa t e i ndi vi dual s , t he C om m er ce R epor temphasi zed thatt h e n ew s y s t em w oul d r educe and sta b ili z e lit ig a tio n c o sts w h ile a lso e n a b lin g m a n u f a c tu re rs to e stim a te th e c o sts a ss o c iate d w it h c o m p e n sa tio n . F in a lly , it exp l i ci t l yst at ed thati njur ed indi vidual s could on l yseek redres s i n t he s t at e t or ts y s t em for c er t ai n m anufa cturing defe ctand w a rn in g c la im s . E ac h o f th e o b

jecti v es ex toll ed b y the C o m m erc e R ep o rt w oul d be underm i ned i f design d efe ctcl ai m s w er e perm i t t ed u n d e r th e sta tu te. T h e p lain tiff s’ c o n stru c tio n o f

th e sta tu te w o u ld p e rm it state c o u rts to d e ter m in e o n a c a se -b y -c a se b a sis w hethera vac ci ne manufactur er coul d have conce i vabl ycr eat ed a s afe rvacc i ne. T hi s w oul d undoubt edl yi ncr eas e the cos t s and r i s ks as s oci at ed w i t h l i t i gat i on and w oul d under m i ne a m a n u f a c tu re r’s e f

f o r ts to e stim a te a n d c o n tro l co sts . It w o u ld al s o effect i vel yi m pos e an a ffi r m at i ve obl i gat i on on vacc i ne m anu f a c tu rers t o p ursue, regar dles s of co st , t he co un t l ess avenue s t hr ough w hi ch t hey coul d devel op a s afer vac ci ne. T hes e w er e the verypr obl ems w h ich l ed t o i ns t abi l i t yi n t he vacc i ne mar ket and w hi ch caus ed C ongr es s t o i nt er vene thr ough th e p a s s a g e o f

th e V a c c in e A c t.

b. U nfor tunat el y , ourr evi ew of l egi s l at i ve hi s t or y does not end her e. R athert han r el yon t he C o m m erce Repor t , t he p lai n ti ff s resp o n d that o ther lan g u ag e in the leg isl ati v e h ist o ry s t r on g l yfavor s t hei rpos i t i on t hatdes i gn defe ctcl ai m s ar e not37 pr eempt ed. T he V acc i ne A ct , w hi ch C ongr es s pas s ed i n 1986, di d not i ni t i al l y “i ncl ude a s our ce of paym ent fo r such compensa ti o n and made t he compens at i on pr ogr am and acc om pany i ng t or tr eform s cont i ngenton t he ena ct m ent of a t ax t o pr ovi de fundi ng for t he compens at i on. ” H

. R

. R ep. N o. 100- 3 9 1 (I), a t 6 9 0 (1 9 8 7 ). In 1 9 8 7 , C o n g re ss p a ss e d leg isla tio n to fu n d the co m p en sati o n p rog ram . O n O ctob er 26 , 1 9 8 7 , as p art of t hi s fundi ng l egi s l at i on, t he H ous e C om m i t t ee on the B udget ( “B udget C om m i t t ee” ) i s s ued i t s ow n r epor t( “B udgetR epor t ”) w hi ch s t at ed the fol l ow i ng: I ti s not the C om m i t t ee’ s i nt ent i on t o pr ecl ude cour tact i ons under a ppl i cabl e l aw . T he C om m i t t ee’ s i nt ent at t he t i m e of cons i der i ng t he A ctand i n t hes e amendm ent s w as and i s t o l eave ot herw i s e appl i cabl e l aw unaff ec te d, exce ptas exp res sl yal t ered byt he A ct and t he am end m ents
. A n a m e n d m e n t to e s ta b lish a s p a rt o f th is co m p en sati on s y s t em t hata manufacturer’s fa il u re t o d e v e l o p s a f

e rv a c c i n e was n o tg r o u n d s f or liab ili ty w a s re

jec ted b yth e C o m m itt e e d u rin g its or i gi nal cons i der at ion of the A ct
. Fur t her , t he codi fi cat i on of C om m ent( k) of The R es t at ement (Secon d) of T ort s w as n ot i ntended t o d eci de as a ma t t e r o f l a w t h e c i r c u ms t a n c e s i n whi ch a vacc i ne s houl d be de em ed unavoi dabl yuns afe

. T he C om m i t t ee st r es s es t hatt her e s houl d be no m isu n d e rsta n d in g th a t th e A c t u n d e rto o k to d ec ide as a m att er of law w h ethe r v ac cine s w e re u n a v o id a b lyu n sa f

e o r n o t. T h is q u e stio n is le f t to th e c o u rts to d e ter m in e in a c c o rd a n c e w ith38 a p p l i c a b l e l a w. I d. a t 6 9 1

. A ccor di ng t o t he pl ai nt i ffs , t hi s l anguage dem ons t r at es th a t C o n g re ss c o n sid e re d a n d re jec ted a n a m e n d m e n t th a t w o u ld h a v e e x p licitlyp re e m p ted a ll d e sig n d e f e c t cla im s. T h is ar gum enti s pr emi s ed on the w el l

- s et t l ed not i on t hat“[f ] ew pr i nci pl es of s t a tu t o ryc o n s t ruct i on ar e more compel l i ng t han the p rop o si t i on t hatC ongr es s does noti nt end su b sile n tio t o enac t s t atut or yl anguage t hat i t has ear l i er di s car ded i n favor of other l anguage . ” I

N S v. C ar doz a- Fons eca , 4 8 0 U

. S. 421, 442–443 (19 8 7 ) (i n terna l qu o tat io n m ark s an d cit ati o n o m itted). A ddi t i onal l y , pl ai nt i ffs cl ai m t hatt he B udgetR epor tevi dence s C o n g r e s s ’ s i n t e n tt o p e r m i t c o u r t s t o d e t e r m i n e o n a c a s e - b yc a s e b a s is w h e th e r a v a c c in e ’s s id e e f f e c ts w e re “ u n a v o id a b le .” T h e p rob lem s w ith the B u d g et R ep o rt , h o w ev er, are three -fo ld. First , the B u d g et R e p o rt rep ea tedlyu ses th e term “the C om m i t t ee, ” buti ti s uncl earw hethert hi s r efe r s to the B udgetC om m i t t ee ort he Ener gyand C om m erc e C om m i t t ee. W hi l e the B udgetC om m i t t ee di d not pl ay a rol e i n t he dr aft i ng orpas s age of

t he V acc i ne A ct, t he Ener gyand C om m er ce C om m i t t ee ha d j ur i s di ct i on over the bi l l and hel d s ever al h e a ri n g s o n c h ild h o o d v a c c in e s a n d th e p ro p o s e d le g is la tio n . A subco m m i t t ee of

t he E nergyand C o m m e rce C om m i t t ee al so hel d a hear i ng, know n as a “m ar k- up” hear i ng, on t he V acc i ne A cti n Sept ember 1986 d u ri n g w hi ch t i m e i tcons i der ed

### I nform at i on pe rt a i ni ng t o Congr e s s i ona l pa s s a ge of the 11 

### Va c c i ne Ac t , i nc ludi ng the dat e s of the m arkup hearin g and Commi tt e e c o n s i d e r at i o n , c an b e f o un d o n th e L ib r ary

of Congr e s s ’ s we bs i t e for

l e gi s l at i ve i nform ation. Libr ary of Co ng re ss , TH OM AS , S.17 44 (P.L. 99-66 0): AllCo ng re ss ional Ac t i ons wi t h A m en d m ent s , ht t p: / / t hom a s . l oc . gov/ c gi

- bi n/ bdque ry /z ?d099: SN01744: @@ @S| TOM: / bs s / d099qu ery .h tm l. T he E nergyand C om m erce C om m i t t ee ret ai ns a 12 tra n sc rip t o f

th is h e a rin g , b u t th is tra n sc rip t w a s n o t av a ilab le to u s . 39 amendm ent s t o t he l egi s l a t i o n . Be c aus e the B udgetC om m i t t ee 11 d id n o t c o n sid e r am e n d m e n ts t o th e V a c c in e A c t, w e w ill pr esum e thatr efe r ence s i n t he B udgetR epor tt o “the C om m i t t ee” r efe rt o t he E n ergyand C om m er ce Com m i t t ee. Second, t hough t he E ner gy and C om m er ce C o m m i t t ee con du ct ed a m ark- up hear i ng t o c on si der propo sed am end m ents , no r ecor d i s avai l abl e t o confi r m t hatt he Ener gyand C om m er ce C o m m itt e e c o n sid e re d a n d re jec ted a n a m e n d m e n t re late d to des i gn defe ct s at t hat t i m e. T hi r d, “the vi ew s of a s ubs equent 12 C ongr es s f

o r m a h a z a r d o u s b a s i s f o r i n f e r r i n g t h e i n t e n t o f an ear l i erone. ” U

ni t ed Stat es v. P r i ce , 3 6 1 U

. S

. 3 0 4 , 3 1 3 (19 6 0 ). T h at d an g er is a m p ly p rese n t here , w h ere the s u b seq u en t r ep o rt w as noti s s ued byt he comm i t t ee w i t h jur i s di ct i on overt he l egi s l at i on, butbya com m i t t ee w hi ch pl ay ed no r ol e i n pas s age o f th e V a c c in e A c t. See U nit ed St ates v. U

nit ed M i ne W

orkers o f A m. , 330 U

. S. 258, 281–82 ( 1947)

. W i t houtm or e, w e have n o b a sis to c o n c lu d e th a t th e B u d g e t R e p o rt is a n a c c u ra te40 r efl ect i on of w hat t r ans pi r ed befor e t he E ner gyand C om m er ce C om m i t t ee, orfort hatm at t er , t he mot i vat i ons under l y i ng C o n g re s s ’s e n a c tm e n t o f th e V a c c in e A c t in 1 9 8 6

. F or the s e r easons, and despit e plai nti ffs urgi ng , w e refuse t o vi ew t he r el evant l egi s l at i ve hi s t or y as cont ai ni ng “duel i ng” c o m m itte e re p o rt s . 3. E v en i f C ongr es s di d noti nt end t o pr ohi bi tal l des i gn defe ctcl aim s agai ns tvacc i ne manufactur er s , t he l egi s l at i ve hi s t or yi ndi cat es t hati ti nt ended t o pr eempt t he s peci fi c cl ai m at i s s ue her e. I n t he day s pr i or t o pas s age of t he V acc i ne A ct , t he E ner gyand C om m er ce Com m i t t ee i s s ued a r epor tcont ai ni ng “bac kgr ound i nfor m at i on on t he var i ous i s s ues conce r ni ng c h i l d h o o d v a c c i n e s . . . . ” ( “ Ba c k g r o u n d Re p o r t ” )

. S t a f f o f H. C o m m . o n E n e rg y& C o m m e r c e , 9 9 th C o n g ., C hi ldhood I m m uniz at i ons , atI I I ( 1986)

. T hi s r epor ts t at ed thatt he per tus s i s vacc i ne “i s cons i der ed the mostr eac t i ve of al l t he co m m o n ly u sed v ac cine s an d h as b ee n the o n e o f m o st co n ce rn i n d eb ates ove radver s e ef fec t s of vac ci nes . ” I

d. at 24

. It re c o u n ted th e risk s a n d sid e e f f e c ts a ss o c iate d w ith th e p e rtu ss is vacc i ne, i ncl udi ng neur ol ogi cal pr obl ems and e ven dea t h, and t he eff or t s of par entgr oups t o r ai s e aw ar enes s of thes e s er i ous c o n s e q u e n c e s . I

d. at 24–29. T he B ackgr ound R epor t al s o s t at ed t hat“r es ear ch i s pr ocee di ng on t he effor t t o devel op an ac el l ul ar vacc i ne thatw oul d caus e fe w er si de ef fec t s . ” Id

. at38. N a m e ly , ite x p lain e d th a t r e se a rc h e rs w e re a ttem p tin g to iso late t he r eac t i ve component s of the pertus s is bact er i al cel l s o t hat th e s e c o m p o n e n ts c o u ld b e e x c lu d e d f ro m th e v a c c in e . I

d. at24.41 T he B ackgr ound R epor t al s o expl ai ned t hat J apan ha d us ed s uch a v a c c in e , b u t itin d ica ted th a t th e sa f e tya n d e f

f ica c yo f th is v a c c in e h a d n o t b e e n r e p o rt e d

. I d. I tt hen w arned that
“ c o n d u c tin g c lin ica l tria ls to tes t a n y n e w p e rtu ss is v a c c in e w ill pos e maj orl ogi s t i c, l egal , and ethi cal pr obl ems. ” Id

. T he C om m er ce Repor ton t he V acc i ne A cta l s o c ont ai ned n u m ero u s ref

ere n ce s to the D P T v ac cine

. H

. R

. R ep . 9 9 -90 8

. It not ed the “s er i ous

— and s om et i m es deadl y

— cons equenc es ” of vacc i nes and thatt hi s w as “part i cul ar l yt rue w i t h r egar d t o t he p e rt u s s is ” c o m p o n e n t o f th e D P T v a c c in e . I

d. at 6. B ef

o re w a rn in g o f th e ra m if

ica tio n s o f th e w ith d ra w a l o f “ e v e n a sin g le m anufa ctur er , ” the R epor tal s o hi ghl i ght ed the i n creas i ng num berof l aw s ui t s r el at ed t o t he D PT vacc i ne and r ecogni zed t hatt her e w er e onl yt w o m anufa cturers o f t he D PT vacc i ne at th a t tim e . I

d. a t 6

– 7

. W h e re a s th e p lain tiff

s c o n te n d th a t W y e th a n d its pr edec es s or s knew “form or e than 25 y ear s t hatt he ac el l ul ar vacc ine w as l es s r eac t ogeni c and, ther efor e, s afe rfort he chi l dr en w ho r ece i ve i t ” and s eek t o es t abl i s h l i abi l i t ybyvi r tue of t hatknow l edge, t he two r e p o rt s d i s cus s ed i m m edi at el yabove, t aken t ogether , es t abl i s h t hatC ongr es s i nt ended t o pr eempt s uch cl a i ms . Th e Ba c k g r o u n d Re p o r t i n d i c a t e s t h a t Con g r e s s w as w el l aw ar e of the s t at e of t he ar t conce r ni ng devel opm entof an ace l l ul arD PT vacc i ne. I tal s o evi dence s t hatC ongr es s bel i eved t her e w er e hur dl es befor e s uch a vacc i ne coul d under go cl i ni cal t es t i ng i n the U ni t ed St at es . T he C om m er ce R epor ts t r es s es t he part i cularproblem s faced b yD P T vaccine m anu fact urer s, i n c l u d i n g t h e h i g h n u mb e r o f l a ws u i t s a n d e x i s t e n c e o f o n l yt wo pr oducer s . T he C o m m er ce Repor tt hen conc l udes t hatt he42 “w i t hdr aw al of eve n a s i n g le m anufa ctur erw oul d pr es entt he veryr eal pos s i bi l i t y of vacc i ne s hor t ages . . . [and] a r es ur gence o f p re v e n tab le d ise a se s” a n d th a t th e v a c c in e m a rk e t w ill sta b ili z e o n c e “ m a n u f

a c tu re rs h a v e a b e tter s e n se o f th e ir pot ent i al l i t i g ati on obl i gat i ons . ” I d. at7. T hi s evi dence in d ica tes th a t C o n g re ss w e ig h e d th e v a rio u s c o n c e rn s re late d to the p ertussis v ac cine a n d co n clud ed that D P T m an u fa cture rs s ho u l d b e s h i e l d e d f

r o m l i a b i l i t y f

o r i n j u r i e s a r i s i n g f

r o m t he w h o le -c e ll p e rt u s s is v a c c in e . 4. A s w e s t at ed att he begi nni ng of thi s part , “C ongr es s i onal purpos e is the ‘ ul t i m at e t ouchs t one’ of ouri nqui r y . ” L ori l l ard Tobacco C o. , 533 U

. S. at541 ( quo ti ng C i pol l one , 505 U

. S. at 5 1 6 ). S e c tio n 2 2 (a ) a n d 2 2 (b )(1 ) o f th e V a c c in e A c t co n tain exp res s preem pti on cl auses. F urther, t he st ructure and pu rpose o f § 3 0 0 a a -2 2 o f

th e A c t m a k e c lea r th a t C o n g r e s s in ten d e d to p ree m p t som e d esig n d ef ec t c laim s. T h e leg isl ati v e h ist o ry id e n tifie s th e sc o p e o f

th is pr e e m p tio n , w h ich e n c o m p a ss e s b o th s tr ic t lia b ility a n d n e g lig e n t d e s ig n d e f e c t c la im s . D. T h e D istric t C o u rt d id n o t cle a rlye x p lain th e b a sis o f its s um m aryj udgm ent deci s i on. I t nei t her di s cus s ed t he thr ee types o f pr eempt i on norm ent i oned thatt he mot i on fors um m ary j udgm entr ai s ed onl yexpr es s pr eempt i on. N evert hel es s , t he D i s t r i ctC our tdeci s i on i s cons i s t ent w i t h an expr es s pr eempt i on anal y s i s , and w e t ake i tt o have i nt ended a ppl i cat ion of t hat d o ctri n e. T h e f

o u r po ints discu ssed in th e D istri ct C o u rt ’sT he p art i es di sagree as t o w h e th er Sect i on 22 (b) (2) i s a 13 pr eempt i on cl au se. T hough W y eth cl as s i fi ed i tas s uch, t he D i s t r i ctC our texpr es s l y hel d t hatt he fa i l ur e- t o- w arn cl ai m w as not pr eempt ed. W e need not r eac h t hi s i s s ue, how ever , fort he 43 o p i n i o n we r e g r o u n d e d i n t h e p u rp o s e o f t h e Vac c i n e Ac t
. As di s cus s ed i n Par t I I I

. B above, s uch an anal y s i s i s per m i t t ed w hen c o n stru in g a n e x p re ss p r e e m p tio n c lau se . F u rth e rm o re , in r es p o n s e t o t h e mot i o n f o rs u mma r yj u d g me n t , t h e p l a i n t i ffs c ited to th e V a c c in e A c t’s le g isla tiv e h isto rya n d p u rp o se to s uppor t t hei rar gum entt hatdes i gn defe ctcl ai m s w er e not pr eempted

. A s a r es ul t , w e r ej ectpl ai nt i ffs ’ ar gum entt hatt he D istric t C o u rt’s d e c isio n w a s b a se d o n im p lied o r f ield pr eempt i on gr ounds or t hat i t vi ol at ed w el l

- s et t l ed pr i nci pl es of s u m m a ry ju d g m e n t. I V. P lain tiff s a lso a lleg e th a t W y e th is liab le f o r f a ili n g to w arn H annah’ s doct or , J ane M

. B r eck, M

. D

. , t hatt he vac ci ne a d mi n i s t e r e d t o Ha n n a h c a me f r o m a l o to f

T RI

- I M M UNOL as s oci at ed w i t h atl eas tt w o deaths and m or e t han thi r t yi nj ur i es pr i ort o A pr i l 1992. D r . B r eck t es t i fi ed t hathad s he know n t hat t he vac ci ne ca m e fr om t hi s l ot , s he w oul d nothave a dm i ni s t er ed th e d o s e . A lth o u g h § 2 2 (c ) o f th e V a c c in e A c t ex p re ss ly p ree m p ts fail u re-to-w arn claim s b ase d o n “the m an u fa cture r’s fai l ur e t o pr ovi de di r ec tw arni ngs t o t he i nj ur ed part y( ort he injured p arty ’s l eg al rep rese n tat ive),” 4 2 U

. S

. C

. § 3 0 0 aa -22 (c), not hi ng i n t he V acc i ne A ctexpre s s l ybar s cl ai m s bas ed on f a ilu re to w a rn “ d o c to rs a n d o th e r m e d ic a l in te rm e d ia ri e s .” 13re a s o n s s e t f o rt h in th is s e c tio n .

44 A s d iscu ssed ab o v e, § 2 2 (b)(1 ) st ates tha t m an u fa cture rs sh all n o t b e l iable fo r injuries ca u sed b y“sid e e ff ec ts th at w ere una v o i d a b l e e v e n t h o u g h t h e v a c c i n e . . . was a c c o mpa n i e d by pr operdi r ect i ons and w arni ngs . ” S ec ti o n 22( b) ( 2) s t at es t hat pr operdi r ect i ons and w arni ngs w i l l be pr es um ed w hen the m a n u f a c tu r e r “ c o m p lied in a ll m a ter ial re sp e c ts w ith a ll r equi r ement s under t he Feder al Food, D rug, and C os m et i c A ct

. . . and s ect i on 262 of thi s t i t l e . . . . ” N evert hel es s , t he V acc i ne A ct pr ovi des t w o ci r cumst ance s i n w hi ch t hi s pr es um pt i on can be o v e r r i d d e n : ( 1 ) whe n t h e ma n u f a c tu r e re n g a g e s i n c onduct th a t w o u ld su b

jec t it t o p u n iti v e d a m a g e s u n d e r th e V a c c in e A c t; and ( 2) w hen t he m anufa ctur er “fa i l ed t o exer ci s e due c ar e. ” 42 U .S .C . § 3 0 0 a a -2 2 (b )(2 )(A )-(B ). A s th e D istric t C o u rt c o rre c tly not ed, t hi s cr eat es a s hi ft i ng bur den— o n ce t he manufactur er e sta b lis h e s th a t itc o m p lied w ith f e d e ra l law , the b u rd e n sh if ts to the p lai n ti ff

to es tablish tha t ei ther § 2 2 (b )(2)(A ) or § 2 2 (b )( 2 )( B ) h a s b e e n m e t. T he D i s t r i ctC our tdi s m i s s ed thi s cl ai m on t he gr ound t hatW y eth w as ent i t l ed t o t he s t atutory p res um pt i on of pr oper w arning and thatt he pl ai nt i ffs had fa i l ed t o r ebutt he pr esum pt i on. N ot i ng t hatW y eth had pr es ent ed uncont es t ed evi dence t hatT R I- I M M U N O L and i t s w arni ngs had bee n appr oved byt he FD A , t he D i s t r i ctC our t found thatW y eth w as e n tit led to § 2 2 (b )(2 )’s p re su m p tio n o f p ro p e r w a rn in g . N e x t, t he D i s t r i ctC our tnot ed thatt he A m ende d C o m p l ai ntdi d not al l ege f r aud orw r ongful w i t hhol di ng of i nfor m at i on w i t hi n t he

### Th e D i str ic tC our tacknow l edged thatt he or i gi nal 14 C om pl ai ntal l eged thatW y eth had com m i t t ed fr aud orw r ongful w i t hhol di ng of i nfor m at i on, but the A m ended Com pl ai ntfai l ed t o do s o. N evert hel es s , even i f t he A m ended C om p lai n t ha d re p e a ted th is a ll e g a tio n , the D istric t C o u rt su g g e ste d th a t it w o u ld n o t hav e su rviv ed ap p li ca ti o n o f F ed

. R

. C iv. P. 9(b ), w h ich re q u ire s th a t a lleg a tio n s o f f ra u d b e p led w ith p a rticu lar ity


### . A s t h e D i stri ctC ou rtexp l ai ned , “V A E R S i s a dat abase 15 cr eat ed, pur s uantt o t he V ac cine A ct , byt he FD A and the C e n ter s f o r D ise a se C o n tro l an d P re v e n tio n to re c e iv e re p o rts aboutadver s e event s w hi ch maybe as s oci at ed w i t h vacc i nes 

### .”

45 m eani ng of § 22( b) ( 2) ( A ). T hus , t he onl yr el evantques t i on 14 w as w heth er p l ai nt i ffs had pr es ent ed cl earand convi nci ng e v id e n c e th a t W y e th h a d n o t e x e rc is e d d u e c a re . P l a i nt i ff s pr e s e nt e d a r e po r tof t he V a c c i ne A dv e r se E ventR epor t i ng Sy s t em (“ V A E R S”) confi r m i ng t hatt he l otof 15 T R I

- I M M U N O L t hat i ncl uded t he dos e admi ni s t er ed t o H annah B ru e se w itz w a s a ss o c iate d w ith tw o d e a th s an d m o re th a n th irty i n j u r i e s . T h e ya l s o p r e s e n t e d t h e a f f i d a v i to f Dr

. Don a l d H. M a r k s , who c l a i me d t h a t s u c h a l o t i s s o me t i me s c a l l e d a “hot l ot
. ” D r . M ar ks r el i ed on a 1984 m emora ndum byan epi demi o l o g i s tatt he D epart m entof H eal t h and H um an Ser vi ces (“ H H S ” ) r e g a rd in g t h e “ In v e s tig a tio n o f P o te n tia l H o t L o ts ,” w h ich sa id th a t “p o ten tial h o t f ill lo ts o f D T P v a c c in e ” a re “ f

ill l ot s t hatexce eded a t hr es hol d of 2 d ea ths o r 2 convul s i ons or46 1 0 to tal re p o r ts .” T h e D istric t C o u rt, h o w e v e r, f o u n d it s i gni fi cantt hatt hi s m emora ndum i dent i fi ed s uch l ot s m er el yas
“ p o te n tia l” h o t lo ts
. T he m emora ndum al s o s t at ed t hat“[i ] n or dert o pr ocee d w i t h an i nves t i gat i on by w hi ch w e coul d di ffe r ent i at e r epor t i ng b i a s f r o m a h i g h e r r a t e o f r e a c t i v i t y i n s p e c i f i c f i l l l o t s we neede d i nfor m at i on on t he number of dos es d ist ri but ed and w h ich per cent w ent t o the pub l i c sect or. ” T hu s, i n o rd e r to d i f f e r e n tia te b e tw e e n a “ h o t lo t” a n d a “ p o te n tia l h o t lo t,” in v e stig a to rs m u st k n o w n o t o n ly th e to tal n u m b e r o f in c id e n ts butal s o t h e r at e atw hi ch the i nci dent s occurr ed. B eca us e the “[p] l ai nt i ffs have p rod u ce d no evi dence fr om w hi ch a tr i erof fac tcoul d i n fe r t hatt he dos e i n ques t i on or i gi nat ed” i n s uch a l ot , t he D i s t r i ctC our tconcl ud ed thatt he pl ai nt i ffs had not pr oven thatW y eth fai l ed t o exer ci s e d u e car e bydi s t r i but i ng d o s e s f ro m th is lo t. B efor e thi s C our t , t he pl aintif fs ar gue thatt he D i s t r i ct C our t ’ s r eas oni ng i s fl aw ed on tw o gr ounds : ( 1) W y eth i s not en t i t l e d t o a p r e s u mpt i o n o f p r o p e r warn i n g u n l e s s t h e s i de effects of the vaccine are fir st show n to be un avo i dab l e; becau se t heyal l ege a s afe rvacc i ne des i gn w as avai l abl e, t heyar gue that § 22( b) ( 2) s houl d notappl y ; and ( 2) D r . M ar k’ s opi ni on r ai ses an i s s ue of f

actas t o w hetherH annah’ s dos e ca m e fr om a “hot l ot
. ” W e di s m i s s bot h ar gum ent s . T h e fi r s tar gum entm us tbe di s m i s s ed fort he r eas ons di s cus s ed i n Par tI I I

— t he V acc i ne A ct pr eempt s des i gn defe ctcl ai m s pr emi s ed on the noti on t hatt he m anufa ctur ercoul d have c r eat ed a saf ervacc i ne. T he s econd re q u ir e s m o re d is c u s s io n .

### D r. Marks a l s o a ppr ovi ngl y

c i t e d t o an ol de r

doc um e nt 16 

### f ro m th e F o o dan d D ru g A dmin istratio n . T h is d o cum ent states:

I n anal y zi ng pat t erns o f ad ver s e eve ntr epor t i ng, t he FD A cons i der s m o re than j us tt he number of r epor t s for a l ot
. M or e r epor t s w i l l be re ce ived for a lar g e lott han a sm al l on e, si m plybecau se v ac cine fro m the larg e lot w il l be g ive n to m o re chi l dr en. Som e l ot s cont ai n as m anyas 700, 000

47 A s stated a b o v e, a c o u rt m ayn o t gran t sum m ary ju d g m e n t so lo n g a s the re e x ists a g e n u in e iss u e o f m a ter ial f

a c t. F ed

. R

. C iv. P. 56 (c); Kaucherv. C ount y of B u cks , 455 F. 3d 4 1 8 , 4 2 3 (3 d C ir. 2 0 0 6 ). T o d e ter m in e w h e th e r a f a c tu a l d isp u te i s genui ne, “the cour t ’ s funct i on i s not t o w ei gh t he evi dence or t o det er m i ne the t rut h of the mat t er , butonl yt o det er m i ne w h ethe r t h e e v iden ce o f re co rd is su ch th a t a re aso n ab le j u ry coul d r etur n a ver di ctfort he nonmovi ng par t y . ” O rs at t i v. N

. J. S t a t e P ol i ce , 7 1 F .3 d 4 8 0 , 4 8 2 (3 d C ir. 1 9 9 5 ); see al so A nders on v. Li ber t

y Lobby, I

nc. , 477 U

. S. 242, 248 ( 1986)

. T he “mer e exi s t ence of a s ci nt i l l a of e vi dence ” i n s uppor tof the n o n m o v in g p a rt y ’s c la im is in s u f f ic e n t. A nders on , 477 U

. S. at 2 5 2 . W e w ill re so lv e a ll d o u b ts a n d d ra w a ll rea so n a b le in f e re n c e s in f

a v o r o f th e n o n m o v in g p a rt y . C onos hent i v. P ub. Ser v. E l ec. & G as C o. , 3 6 4 F .3 d 1 3 5 , 1 4 0 (3 d C ir . 2 0 0 4 ). D r. M a rk s id e n tifie d th e H H S m e m o ra n d u m a s th e b a sis on w hi ch he dr ew hi s concl us i ons : “Thi s m emora ndum pr ovi des w h a t I u n d e rs to o d to b e th e o f f ic ia l d e f in itio n o f a ‘H o t L o t’ .” 16do ses, w hil e other s as few as 20,0 00 do ses. Si m i l ar l y , m o r e r epor t s w i l l be r ece i ved fora l ot th a t h a s b e e n in u se f

o r a lo n g tim e th a n a lo t in us e fora s h o r tt i me . Ev e n a mon g l o t s o f s i mi l ar size a n d ti m e in u se, so m e lots w il l r ec eive m o re rep o rt s t han other s s i m pl ydue t o change

. T he FD A cont i nual l yl ooks forl ot s t hat have r ece i ved m or e ser i ous r epor t s t ha[n] s houl d be expect ed on t he bas i s of such f

act or s as s i ze, t i m e i n us e, and c h a n c e v a ri a tio n . P u b . H e a lth S e rv ., D e p ’t o f H e a lth & H u m a n S e rv s ., 

### Vac c ine Adv e r s eEv e nt Re por ting Sy

s te m (VAERS) 2

. O th er auth o rities sup p o rt th is. F o r in stan ce, acco rd in g to 17 

### th e C enters f

o r D isease C o ntro l an dP rev entio n : V acc i ne l ot s ar e nott he s ame. T he si zes of vacc i ne l ot s m i ghtvary from s ever al hundr ed th o u sa n d d o se s to se v e ra l m ill io n , an d so m e a re in d i s t r i b u t i o n m u c h l o n g e r t h a n o t h e r s . N a tu r a l l y a lar g e r l o t o r on e th a t is i n d istrib u tio n lo n g e r w ill be ass oci at ed w i t h m or e adve r s e eve nt s , s i m pl yby ch an ce . A lso, m o re c o inc iden tal d ea ths a re

48 A s th e D istric t C o u rt c o rre c tly n o ted , th e m e m o ra n d u m c lea rly st at es th a t t he inci den tst at i st i cs, ci t ed ab ov e, on l yest abli sh “po t entia l ho tl ots
. ” Itfurt her st at es that i nv est i gator s m ust i dent i fyt he number of dos es admi ni s t er ed t o det er m i ne w hether a part i cularvaccine l ot qu al i fi es as a “hot l ot. ” B ecause 17as s oci at ed w i t h vacc i nes g i ven i n i nfanc yt han late r in c h ild h o o d , sin c e th e b a c k g ro u n d d e a th r at es forchi l dr en ar e hi ghes tdur i ng t he fi r s ty ear of l i fe. So know i ng t hatl otA has been a s s oci at ed w i t h x nu m b er of adve r s e eve nt s w hi l e l otB has b e e n a s s o c i a t e d wi t h y n u mbe r wou l d not n e c e ss a rily sa ya n y th in g a b o u t th e re lativ e sa f e ty o f the tw o l ot s , even i f the vac ci ne d id caus e the e v e n ts


### . Ce nt er s for

Di s e a s e Contr oland Pr e ve nt i on, Som e Comm on M isco n cep tio n s Ab o ut V a c c i n atio nan dH o wto R esp o n dto T h e m, ht tp:/ /w w w . cdc. gov/ vacc i nes / vac- gen/ 6m i s hom e. ht m #T her ear ehot


### . 49 p lai n ti ff s h av e n o t of

fe re d an yev iden ce o n this po int, D r. M ark s’ asse rt ion s an d co n clus ion s are u n su p p o rt ed b ythe v ery m e m o ra n d u m u p o n w h ic h h e re lie s . T he pl a i n t i f

f s a l s o c o n t e n d t h a tt h e s h e e rn u mbe rof a d v e rse e v e n ts a ss o c iate d w ith th is v a c c in e lo t is su f f icie n t to estab li s h “s o m e e v iden ce o f a seriou s h ea lth p rob lem n o [m att er] h o w m a n yd o se s, c irc u m sc rib e d b yth e c o n c e p t o f a b a tch , it cont ai ns . ” W hi l e thi s m aybe true, t he pl ai nt i ffs ’ bur den i s not t o pr oduce “ s om e evi dence ”— a mer e s ci nt i l l a— butevi dence s u f f i c i e n tf o r a r e a s o n a b l e j u r yt o f i n d i n t h e i rf

a v o r . T h e HHS m emora ndum s t at es t hat i nves t i gat or s cannotconcl ude w hether a vac ci ne lot i s a “hotl ot ” w i t houtevi dence on t he number of dos es admi ni s t er ed. T hus , even dr aw i ng al l i nfer en ce s and50 doubt s i n favor of t he pl ai nt i ffs , t her e i s i ns uffi ci ent evi dence on w hi ch a j ur y coul d concl ude thatH annah’ s vacc i ne ca m e fr om a “ho tl ot. ” A ccordi ng l y , t he D i stri ctC ou rtdid not err i n g r a n t i n g s u mma r yj u d g me n to n t h e f a i l u r e t o wa r n c l a i m. V. I n t hei rA m ended Com pl ai nt , t he pl ai nt i ffs al l eged that W y eth’ s “manufactur i ng pr oces s and i nadequa t e qual i t ycontr ol re su lted in re c u rre n t p ro b lem s w ith m a in tain in g th e a p p ro p ria te b a lan c e b e tw e e n n e u ro n -to x in s an d e n d o -to x in s in th e p e rtu ss is vacc i ne. ” Pl ai nt i ffs al s o as s er t , as t heydo befor e thi s C our t , t hat t heyhav e a “cl as s i c manufactur i ng defe ctcl ai m her e: t hatt he v a c c in e lo t u se d o n H a n n a h B ru e se w itz w a s tain ted su c h th a t it w a s a s s o c ia te d w ith tw o d e a th s a n d m o re th a n 6 6 i n j u ri e s , a n u m b e r a n d p e rc e n ta g e f a r i n e x c e s s o f

th a t f o r o th e r l o ts .” U nderPenns y l vani a l aw , a pl ai nt i ff a l l egi ng a ma n u fa ctur i ng defe ct bas ed on a s t r i ctl i abi l i t yt heorym us ts how t hat : ( 1) “the produ ctw as defecti ve;” ( 2) “t he d efect w as a p rox i m at e cause o f th e p lai n ti ff ’s i n

juri es;” a n d (3) the d ef

ec t cau sing the in

jury exi s t ed at t he t i m e t he pr oduct l eft t he s el l er ’ s hands

. ” B e rk e b ile v. B r ant l y H el i copt erC or

p. , 3 3 7 A

. 2 d 8 9 3 , 8 9 8 (P a. 19 7 5 ). T h e D istric t C o u rt h e ld th a t p lain tiff s h a d f a iled to p ro v id e e n o u g h e v id e n c e o f a m a n u f a c tu rin g d e f

e c t to m e e t th e ir bur den forpurpos es of s um m aryj udgm en t. W it h r egar d t o t he fi r s tcl ai m , r el at ed t o t he bal ance of neur o- and endo- t oxi ns , t he D istric t C o u rt c o n c lu d e d th a t “P lain tiff s h a v e o f f e re d a b so lu tely no evi denc e to su ppor tt hi s al l egat i on . . . . ” M or eover , t he D i s t r i ctC ourt n o ted t hi s cl ai m w as di r ect l yr efut ed byW y eth, w h ich o f f e re d u n d isp u ted e v id e n c e th a t it s p e rtu ss is v a c c in e d id51 notcont ai n a neur o- t oxi n component and w as notknow n t o have a n e u ro -t o x ic e f

f e c t. T he D i s t r i ctC our t al s o cons i der ed the pl ai nt i ffs ’ s econd arg u m en t, w h ich w as e ssen ti all ythe sam e as th e “h o t lot” theo ry di s cus s ed above

. T he pl ai nt i ffs ar gued t o t he D i s t r i ctC our tt hat a “hotl ot ” ca n s er ve as ci r cumst ant i al evi dence of a m an u fa cturing d ef

ec t. T h e D istri ct C o u rtn o ted th at t h is th eo ry is k n o w n a s th e “ m a lf

u n c tio n th e o ry :” T h e m a lf

u n c tio n th e o ryp e rm its a p lain tiff to pr ove a de fec ti n a pr oductw i t h evi dence of the occurr ence of a malfu n ct i on and w i t h evi dence el i m i nat i ng abnor m al u se o r re as onabl e, s econda r ycaus es fo r t he mal funct i on. T he p lain tiff is re liev e d f

ro m d e m o n stra tin g p re c ise ly t he def ecty eti tper m i t s t he tr i er - of- fac tt o i nfer one exi s t ed fr om evi dence of the mal funct i on, of t he abs ence of abnor m al us e and of t he abs ence of reas on able s econ darycauses. B ru e se w itz v . W

y e th , 508 F. Supp. 2d 430, 450 ( E

. D

. Pa. 2007) ( quot i ng B ar nish v. K W I B ldg. C o. , 916 A

. 2d 642, 646 (P a . S u p e r. C t. 2 0 0 7 ))

. A s t he D i s t r i ctC our tr ecogni zed, t hi s t heoryhas notbeen appl i ed t o al l egedl ydefe ct i ve vac ci nes . N evert hel es s , w e nee d n o t d e ter m in e if

a n d h o w th is th e o ry o f

liab ili tyw o u ld a p p lyin t hi s cas e. B o th befor e the D i s t r i ctC our tand thi s C our t , t he pl ai nt i ffs pr edi cat ed thei rar gum entfor a manufactur i ng defe ct on t he fa ctt hatH annah’ s vacc i ne ca m e fr om a “hot l ot
. ” F ort he52 r eas ons s t at ed i n Par t I V , aft erdr aw i ng al l r eas onabl e i nfer ence s in f av o r of the p lai n ti ff

s, w e a g ree w ith the D istri ct C o u rt ’s concl us i on t hatt he pl ai nt i ffs h ave notpr ovi ded evi dence fr om w hi ch a j ur ycoul d concl ude thatH annah w as adm i ni s t er ed a v a c c in e f ro m a “ h o t lo t.” B e c a u se p lain tiff s s o le a rg u m e n ts to t hi s C our ton t he manufactur i ng defe cti s s ue r equi r e a f i ndi ng of a “hotl ot , ” w e w i l l al s o aff i r m t he D i s t r i ctC our t ’ s j udgm enton th is c la im

. V I. W e h o ld th a t the p lai n ti ff s d esig n d ef

ec t cl aim s are expr es s l ypr eempt ed byt he V acc i ne A ct
. W e al s o concl ude that t he pl ai nt iffs have fai l ed t o es t abl i s h ei t hera manufactur i ng defe ctora w arni ng defe ctcl ai m under t he V acc i ne A ct
. For t he rea so n s d iscu ssed ab o v e, w e w il l aff irm th e D istri ct C o u rt ’s g ra n t o f s u m m a ry ju d g m e n t in f a v o r o f W y e th

.