1 (Slip Opin i o n) OCTOBER T ERM, 20 10 Sy llabu s N O TE : Wh er e it i s feas ibl e , a s y llab u s (h ead n ot e) wil lbe rel e as ed , as is bein g d o n e incon n ecti onwithth is cas e , a tth e ti meth e op in i o n is is s u ed

. Th e s y ll abu s con s titu tes n o p a rt of th e op in i o nof th eC o u r t bu t h a s be en pre p are dbyt h e Re po rte ro f De ci sio n s fo r t h e co nveni e nce of t h e reade r . Se e United Statesv. Detroit Timbe r& Lumb er Co., 200U. S

. 3 21, 337

. 

# SUPREME CO URT O FTHE UNI TED STATES
Sy llabu s 

### BRU ESEW ITZ ET AL


### . v . WYETH LLC, FKA 

### WYETH, I N C., ET AL


### . CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT No. 09–1 52. Ar g u ed Oc tober12, 2010—Dec i ded Febr uar y22, 2011 The National Childhood Vaccine InjuryAct of 19 86 ( N C VIA or Ac t) c r e ated a no-faul t c o mpensatio npr ogr a m to stab ili ze a v a c c i ne mar k et a dvers ely a ffect ed b ya nincrea s e in va ccine-rela t ed tortlit igat ion and to f a cilit a t e compensa ti on to clai man t s who found pursuing le

gi tima te v a c c i ne-inflic ted injur i es too c o s t lyand diffic u l t
. The Ac t pr ov ides th at a par t y allegi n ga v a c c i n e -r elated in ju r ymayfile a pet i

tion forc o mpensation in t h e Cour t of Feder a l Cla i ms , namingthe Health and H u man Serv ic es Sec r e ta r ya s the r e spond e nt; that the c o ur t must r e solv e the c a se bya spec ifie d deadl i ne; a n d that the cla i m a ntca n t h en decide w h et her t oa c ce ptt h e cou r t ’ s j u dgm e ntor rej e ctita n d seek t o rtrelief fromt h e va cci ne m a nufa c t u rer. Awa r ds ar e paidou t o f a fu n dc r e at ed byanexcise t a x on ea ch va ccine dos e . As a quid pro quo, manufacturers enjoy signif icant tort-liab ility pro

tections. Most importantly, the Act elimina t es manufactu rer liability for a vaccine’s unavoidable, adverse side effects.

Ha nna h Brue s e witz’s pa ren t s filed ava ccine-inj ury peti tion in the Cou r t of Feder a l Claim s , c l aimin gth at Han n a hbec a me disab l ed af

t e r receivin g adipht h eria , t e t a nus , a n d pert us s i s (DTP) va ccine manufactured by Lederle Laboratories ( n ow owned b yrespondent Wy eth). After that c o ur t denied thei rc l aim, theyelec ted to r ejec tthe u n f av or able ju dg men tan d fi led su it inPe n n s y lv a n i a st ate c o u r t, al

leging, i n ter a lia, that the defective design of Lederle’s DTP vaccine c a u s ed Han n a h ’ s disabil i tie s , an d th at Leder l e was su bjec t to str i c t liab ility and l i abi lity for negligent design under Penns ylvania com

mon law. Wy eth r e mov e d t h e suit to the Feder a l Dis t r i c tCour t. I t g r anted Wy eth summar yjudg ment, holdingthat the r e lev a nt Penn

sy lv an ia l a w was pr eempte dby4 2 U. S. C. §30 0aa–2 2(b)(1), wh ic h2 BRUE S EWIT Z v. WYETH LLC Sy llabu s pr ov ides that “[n]o v a c c i ne manufac tu rer shall be liable in a civil ac

t i on for da mages a r is ing froma va cci n e -r elatedin ju r yordeath as so c i ated withth e admin i str a ti onof a v a c c i ne afterOc tober1, 1988, if the injury or death resultedfromside-effe cts that were unavoidable even tho u gh th e vaccine was proper lypr epar ed an d was ac c o mpan ied by proper dire ctions and warnings .” TheT h ird Circuit af firmed. Held: The NCVIA preempt s all de sign-d efec t c l aims a g ainst v a c c i ne

man u f ac tu r e rs br ou gh t byplain t iff s seek ing compensation for injury ordeathc a u s ed bya v a c c i n e ’s side effec t s. Pp. 7–19.

(a) Sec t ion30 0aa–2 2(b)(1)’ s tex tsu g g e sts th at a v a c c i n e ’s desig n is not open to question in a tor tac ti on. If ama nufa c turer could b eheld liable for fai l ure to use a dif f eren t desig n , the “ev e n tho u gh” c l ause would do no work. A vaccine side effect could alway shave been av oidable by u s e of adiffe r e n tv a ccine not conta i ning the ha rmful element. The language of th e prov isionth u s su g g e sts th e desig nis not subjec t to question in a t o r tac tion. What the statute establi s he s as a complete defense must be unavoidability (given safe manufac

tur eand war n ing) with r e sp ec t to th e part icular design. This conclu

sionis su ppor t ed by th e fac tthat, althoughpr oduc ts-liabili tylaw e s tabl ishes three gro unds for liabilit y—defective manufacture, ina d eq ua t e direct ions or wa rnings , a n d defect ive des i gn—t he Act mentions onlyma nufa c ture a n d wa rn ing s . Itthus se ems that the Ac t’ s failur eto mention desig n -defec t liabi li ty is “b y delibe r ate choice, notina dvert ence.” Barnhar tv. Peabody Coal Co. , 537 U

. S. 149, 1 68. Pp. 7–8.

(b) Contr a r yto peti tioner s’ ar g u ment, ther e is no r e a s o nto be liev e th at §30 0 a a
– 2 2 (b)(1)’ s ter m “u n av o idable” is a ter mof ar t in c o r p or at

ing Restate m e n t (Second) of Torts §402A, Comment k, wh i c he x e m p t s from strict liabili ty rules “unavo idab l y uns a f e products .” “Unavoid

ab l e” is ha rdly ara rely us ed word, a n d ca s e s int e rpret i ng com m e nt k att a ch specialsignificance onlyto the ter m“unav o idablyunsafe pr oduc ts,” not the wor d“unav o idabl e” s t an din galon e. Moreover, reading the p h rase “side eff e cts thatwere unavoidable ” to exempt in

juries caused by flawed design wo uld r e quir e tr eating“ev e n though” a s acoordina ting co nj un ction linkinginde pendent idea s whenit is a conces s ive, s u b o rdina t ing conj un ct ion conveyin g t h a tone cla u s e weakens or qualifies the other. Th e c a nonag ain s t su per f lu itydoe s not under mine this Cour t’ s inter p r e tatio nbec a use petitioner s’ c o m petin gin ter p retationh a s su per f lu itypr oblems of its own

. Pp. 8–12. (c) The structure of the NCVIA and of va ccine regula t i on in genera l r e in for c e s what §3 00 aa– 22(b)(1)’ s tex t su g g e sts. D e sig ndefec t s d o not mer i t a single mention in the Ac t or in Food and Dr ugAdmini

str a tion r e g u lations that pe rv asiv elyr e gulate the dr ug manufac tur

ing proces s . This la ck of guida n ce for de s i gn defect s , com b ined with3 Cite as: 56 2 U

. S. ____ (2011) Sy llabu s the extensive guidance fo r th e two liabilit y grounds spe c ifically men

tion ed inth e Ac t, str o n glysu g g e sts th at d e sig ndefec t s w e r en o t men

tioned because they are not a basis forl i ab ili ty
. The Ac t’ s m a ndate s lead to the sa me c o nc lusion. It provides for federal agency improve

m e ntof va ccine des i gn a n d for federa lly pres crib e d c o m p ens a tion, wh ic har e othermean s forac h i ev in g the two beneficialeffects of de

sign-defect torts—promptin g the de velopment of impr oved designs, and providing compensationfor inf lict e d inj u ries

. The Act ’ s s t ruc tur a l qu idpro qu oalso lea d s to th e sa m ec o n c lu sion. Th e v a c c i n e manufac tur e rs fund an infor m al, effic i ent c o mpensationpr og r a m for va ccine inj u rie s in excha n ge for av oiding co s t ly t o rt litigat ion a n d t h e occa s i ona ldisproport iona t ej u ry ve rdic t. Tax i ngtheirp r oduc t to fund the compensation program, while le aving their liabi lity f o r design de

fectvirt ua lly una lt ered, would ha rdly coa xt h emb a c k int ot h e m a r ket. Pp. 13–16. 561 F. 3d 23 3, affir m ed.

S CALIA , J., delivered the opinion of the Cour t, in whic h R OBERTS , C. J., and K E NNEDY , T HOMA S , B REYER , an d ALITO , JJ., j o ined. B REYER , J., filed a concurring opinion. S OTOMAYOR , J., filed a diss enting opinion, in which G IN S B U R G , J., joined. K AGAN , J., took no part i nthe considera

tion or decision of the case._________________

_________________ 1 Cite as: 56 2 U

. S. ____ (2011) Opinion of theCourt NOTIC E : Th is op i n ionis subjec t to f o rma lrevi si onbef o r e publicat ioninth e p r eli m in ary p rin t of th e U n it edS t at es R e p o rts
. R e ad ers ar e r e qu es ted to n o tif yth e R e p o rt e rof D e c i s i on s , Su p r em e C o u rt of th e U n ited St at es , Wa s h

ington, D. C. 2054 3, of any typ o gra p hical or other f o rmal err o rs , in or der th atc o rr ect i on sm a y b e mad eb e f o r e th ep r e lim in aryp rin t go es t o p r es s . 

# SUPREME CO URT O FTHE UNI TED STATES
No. 09–1 52 

### RUSSEL L BRU ESEW ITZ, ET AL 

### ., PETITIONERS v. WYETH LL C, FKA 

### WYETH, INC., FKA 

### WYETH LAB O RAT O RIE S , ET AL


### . ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEAL S FOR THE THIRD CIRCUIT [Febr u ar y22, 2011] 

### J USTICE 

### S CALIA 

### delivered the opini o n of the Co urt. We consider whether apreemption provision enacted i n the National Childhood Vaccine Injury Act of 1986 (NCVIA) 1 

### bars state-law design-defect claims against vaccine manufacturers

. I A For the last 66 years, vaccines have been subj ect to th e same feder a l premarket approv al process as prescription drugs, and compensation for vacc ine-related injuries has been left la rgely to the States. 2 

### Under thatregime, the eliminationof communicable disea s es through vaccination became “on e of the greatest achievements” of public healt h in the 20th century. 3 

### But in the 1970’s and 1980’s vac

-

——————

1 42 U. S. C. §300a a– 22(b)( 1 ). 2 See P. Hutt, R. Merrill, & L. Gr ossman, Food and Drug Law 91 2– 913, 14 58 (3d ed. 2007).

3 Centers for Disea s e Control, Achi ev emen t s inPu blicHealth , 190 0– 1 9 9 9 : Im pa ct of Va ccines Univers a lly Recom m e nded forChildren, 48 M o rb idityan d M o r t alityWeeklyRepor t243, 247 (Apr . 2, 199 9).2 BRUE S EWIT Z v. WYETH LLC Opinion of theCourt 

### cines became, one might say, vic t ims of their own succe ss. They had been s o effective in p r eventing infectious di s eases that the public became much less ala r med at the threat of th ose diseases, 4

### and much more concerned with the risk of injury from the vaccines themselves. 5 

### Much of the concern center ed around vaccines against diphtheria, tetanus, and pertus s is (DTP), which we re blamed forchildren’s disabilities and devel o pmental d e lays. This l e d to a mas s ive increase in vaccine -related tort litigation. Whereas between 1978 and 1981 only nine product-lia bility suits were filed against DTP manufactur

ers, by the mid-1980’s the suits numbered more than 20 0 each year. 6

### This destabilized th e DTP vaccine market, causing two of the three domestic manufacturers to with

draw; and the remaining manufacturer, Lede rle Laborato

ries, estima ted that its potential tort liability exceeded its annual sales by a factor of 200. 7 

### Vaccine shortages arose when Lederle had production problems in 1984

. 8 

### Despite the large number of suits, there were many complaints that obta ining comp ensation for legitimat e vaccine-inflicted injuries was too costly and difficult. 9 

### A

——————

4 See Mortimer, Immunizatio nAgai ns t Infectious Dis e ase, 2 0 0 S c i

en c e902, 906 (197 8).

5 See Nationa lVaccine Adv i soryCommit t ee, A Compre hensiv e Re

view of Federal Vaccine Saf e ty Prog r a ms and PublicHealth Ac tiv i t i es 2–3 (Dec. 2008) (her einafter NVAC), h ttp ://www.hhs.gov/nvpo/nvac/ documents/vaccine-safety-review.pdf (as v i sitedFeb. 1 8 , 20 11, an d available in Cl erk of Cour t’ s c a se file).

6 See Sing & Willian, Supplyi ng Vaccine s: An Ove rview of the Market and Regulator yContext, in SupplyingVaccines: An Economic Analy s i s of Cr itic al I s s u es 45, 5 1–5 2 (M . Pau l y , C. Robin s on , S. S e pe, M

. Sin g , & M. William ed s. 1996).

7 See id., at 52. 8 See Centers for Disease Co ntrol, Dipther i a - Teta nus -Pertus s i s Va c cine S h ort a ge, 3 3 Morb idity a n d Mort a lit y Weekly Report6 9 5

– 696 (Dec . 14, 1984).

9 See Apolinsky& Van Dett a, Rethinki n gLiabil i tyforVac c in e In ju ry, 19 Cor n ell J. L. & Pu b. Pol’ y537, 550 –5 5 1 (2 010); T. B u r k e, Lawy er s,3 Cite as: 56 2 U

. S. ____ (2011) Opinion of theCourt 

### significant number of parents were alre ady declini n g vaccinationfor their c h ildren, 10

### an d concerns about com

pensation threatened to depress vaccinationrates eve n further. 11 

### This was a source of concern to public health officials, si nce vaccine s are effective in preventing out

break s of disease on ly i f a large percentage of the popula

tion is vaccinated. 12 

### To stabilize the vaccine market and facilitate compensa

tion, Congress enacted the NCVIA in 1986. Th e Act estab

lishes a no-fault compensation program “desig ned to work faster and with greate r ease thanthe civil t o rt system. ” Shalalav. Whitecotton , 514 U. S. 268, 269 (1 995). A per

son injured by ava cci ne, or his legal guardi an, may fil e a petition for compensation in the United States Court of Federal Claims, naming the Se cretar yof Health an d Human Se rvices as the respondent. 13 

### A special master then makes an informal adjudication of the petition within (except for two limited exceptions) 240 days. 14 

### The Court of Federal Claims must review o bjections to the special master’s decision and enter final judgment u n der a simi

larly tight statutory deadline. 15

### At that point, a claimant has two options: to acc e pt the court’s judgmen tand forgo a traditional tort suitfordamage s, o rto reject t h e judgmen t and seek tort relief from the vaccine manufacturer. 16 

### Fast, informal adjudication is made possible by the Act’s Vaccine Inj u ry Table, which list s the vacci nes covered under the Act; desc ribes each vaccine’s compensable,

—————— Lawsuits, andLeg a l Righ ts : The Battle ov erLitig a tio nin Amer ic an Soc i ety146 (2 002).

10 Mort im er, sup r a , at 906. 11 See Hag a n , 45 Food Dru gCosm. L. J. 477, 479 (1 99 0). 12 See R. Merrill, Introduction to Epidemio lo gy65–68 (20 1 0 ). 13 See 42 U. S. C. §300aa–1 1(a) (1). 14 See §300a a– 1 2 (d)(3). 15 See §300a a– 1 2 (e), (g). 16 See §300a a– 2 1 (a).4 BRUE S EWIT Z v. WYETH LLC Opinion of theCourt 

### adverse side effects; and indicates how soon after vac c ina

tion those side effects should first manifest themselves. 17 

### Claimants who show that a listed injury first manifested itself at the appropriate time are prima facie entitled to compensation. 18

### No showing of cau s ation is necessary; the Secretar ybears the burden of disproving cau s ation. 19 

### A claimant may also recover for unlisted side effects, and for listed side effects that occur at times otherthan thos e specified in the Table, but for those the claimant must prove causation. 20

### Unlike in tort suits, claim ants under the Act are not required to show that the administered vaccine wa s defectively manuf actured, labeled, or de

signed. Successful claimants r e ceive compensation for medical, rehabilitation, counsel ing, special education, and voca

tional training expen s es; diminished earning ca pacit y ; pain and suffering; and $250,000 for vaccine-related deaths. 21 

### Attorney’s fees are provided, not on ly for suc

cessful cases, but even for unsucce ssful claims that a r e not frivolous. 22 

### These awards are paid out of a fund created b y an excise tax on each vaccine dose. 23 

### The quid pro quo for this, designed to stabilize the vaccine market, was the provision of significant tort

liability protections for va ccine manufacturers. The Act requires claimants to seek relief through the c o mpensation program before filing s u it for mor e than $1,0 00. 24 

### Manu

facturers are generally immunized from liability for fail

-

——————

17 See §300 aa– 1 4 (a); 42 C F R §100.3 ( 2 0 09) (c u r r e n tVacc in e In ju ry Table).

18 See 42 U. S. C. §§300aa–1 1(c )(1), 300a a– 13 (a)(1)(A). 19 See §300a a– 1 3 (a)(1)(B). 20 See §300a a– 1 1 (c )(1)(C)(ii). 21 See §300a a– 1 5 (a). 22 See §300a a– 1 5 (e). 23 See §300a a– 1 5 (i)(2); 26 U. S

. C. §§4131, 95 10. 24 See 42 U. S. C. §300aa–1 1(a) (2).5 Cite as: 56 2 U

. S. ____ (2011) Opinion of theCourt 

### ure to warn if they have complied with all regulatory requiremen t s (including but not limited to warning re

quirements) and have given the warning e i ther to th e claimant or the claima nt’s physici an. 25 

### They are immu

nized from liability for puniti ve damages absent failure to comply wit hregulatory require ments, “fraud,” “intentional and wrongf ul withholding of infor m ation,” or other “crimi

nal or illeg a l activity.” 26

### And most relevant to the present case, the Act expressly eliminates liability for a vaccine’s unavoidable, adverse side effects: “No va ccine manufactu rer shall be liable in a civil ac

tion for da mages arising from a v a ccine-related injury or death as sociated wi th the adm i nistration of a vac

cine after October 1, 1988, if the injury or death re

sulted from side effects that were unavoidable even though the vaccine was properly prepared and was ac

companied by proper di rections and warnings. ” 27 

### B The vaccin e at issue here is a DTP va ccin e manufac

tured by L e derle Laboratories. It first received feder a l approval in1948 and received supplemental approvals i n 1953 and 1970. Respondent Wyeth purchased Lederle in 1994 and stopped manufacturing the vaccine in 1998. Hannah Bruesewitz was born on October 20, 1991. Her pediatrician administered doses of the DTP vaccine ac cording to t h e Center for Di sease Control’s recommended childhood immunization schedule. Within 24 hours of her April 1992 vaccination, Hannahstarted to experience

——————

25 See §300aa–22(b)(2), (c). The imm unity does not a pplyif the pla i n t i ff es tab l is hes b yclea r a n d convin cing e vidence t h a tt h e m a nufa c t u rer was negligent, or was guilty of frau d, int e ntional and wrongful with

holding of information, or othe ru n l awfu l ac tiv i ty
. See §§30 0aa– 22(b)( 2 ), 300a a–2 3(d)(2).

26 §300a a–2 3(d)( 2 ). 27 §300a a–2 2(b)( 1 ).6 BRUE S EWIT Z v. WYETH LLC Opinion of theCourt 

### seizures. 28

### She suffered over 100 seizures durin gthe next month, and her doctors eventually diagnosed her with “residual seizure disorder” and “developmental delay.” 29 

### Hannah, now a teenager, is still diagnosed with both conditions. In April 19 95, Hanna h’s parents, Russell and Robalee Bruesewitz, filed a vaccine injurypetition in the United States Court of Federal Claims, alleging t hat Hannah suffered from on-Table residual seizure disorder and encephalopathy injurie s . 30

### A Special Master denied their claims on various grounds, though they were awarded $126,800 inattorney’s fees and costs. The B r uesewitzes elected to r eject the unfavorable judgment, and in October 2005 filed this lawsuit in Pennsylvania state court. Their complaint alleged (as relevant here) that defective design of Lederle’s DTP vaccine caused Hannah’s disabilities, an d that Lederl e was subje ct to strict l i ability, and liability for negligent design, under Pennsylva nia common law. 31 

### Wyeth removed the suit to the United Sta t es Distric t Court for the Eastern District of Pennsylvania, which granted Wyeth summary judgme nt on the s trict-liability and negligence design -defect claims, holding that th e Pennsylvania law pro viding thos e causes of action wa s preempted by 42 U. S. C. §300aa– 22(b)(1). 32 

### The United States Cou rt of Ap peals for the Third Circui taffirmed. 33 

### We granted certiorari. 559 U. S. ___ (2010).

——————

28 See Bruesewitz v. Sec reta r y of Health an d Hum a n Serv s. , No. 95– 026 6V, 20 02 WL 319 657 44, *3 (Ct. Cl., Dec

. 20, 2002).

29 561 F. 3d 233, 236 (CA 3 20 0 9 ). 30 See id., at *1. 31 See 561 F. 3dat 237. Th e c o mplain t al so made c l aim s based u p on failure to war nand defecti v e manuf acture. These are no longer at issu e.

32 See id., at 237 –23 8. 33 Id., at 235.7 Cite as: 56 2 U

. S. ____ (2011) Opinion of theCourt 

### II A We set forth again the statutory text at issue: “No va ccine manufactu rer shall be liable in a civil ac

tion for da mages arising from a v a ccine-related injury or death as sociated wi th the adm i nistration of a vac

cine after October 1, 1988, if the injury or death re

sulted from side effects that were unavoidable even though the vaccine was properly prepared and was ac

companied by proper di rections and warnings. ” 34 

### The “even though” clause clarifies the word that precedes it. It delin eates the preventa tive measures that a vacci ne manufacturer mustha ve taken fo r a side-effect to be con

sidered “unavoidable” under th e statute. Provided that there was proper manufacture an d warning, any remain

ing side effects, including those resulting from design defects, are deemed to have b een unavoidable. State-law design-defect claims are therefore preempted. If a manufa cturer could be held liable for failu re to use a different design, the word “una voidable” would do no work. A si de effect of a vaccine could alwa yshave been avoidable b yuse of a differently designed vaccine not containing the harmfu lelement. The language of the provision thus suggests that the design of the vaccine is a given, not s ubject to question in the tort action. What the statute establishes as a complete defense must be un

avoidability (given safe manufacture and warning) with resp ec t to the par t icul ar de sign

. Which plainly implies that the design itself is not open to question. 35

——————

34 42 U. S. C. §300a a– 22(b)( 1 ). 35 Th e dissen tadv o c a tes foran oth e rpossibi lity : “[A] sid eeffec tis ‘unavoidable’ .

. . where there is nofeasible alter n ati v e desig nth at would eliminate the si de eff e ct of the v a c c i ne without c o mpr o misingit s cost and utilit y.” Po st , at 1 5 (opinion of S OTOMAYOR , J. ). Th e dissen t makes n oeffo r tto g r ou n dt h at pos i tion i nth e tex tof § 300 aa–22(b)(1 ).8 BRUE S EWIT Z v. WYETH LLC Opinion of theCourt 

### A further t e xtual indication leads to the same conclu

sion. Products-liability law establishes a cla ssic and well known triumvirate of grounds for liability: defecti ve manufacture, inadequ a te directions or warnings, and defective design. 36 

### If all three were intended to be pre

served, it would be strange to mention specifically only two, and leave the third to implication. It would have been much easier (and much more natural) to provide tha t manufacturers would b e liable for “defective manufacture, defective directions or warning, a n d defective design.” It seems thatthe statute fails to mention design-defect liability “by deliberate choice, not inadvertence.” Bar n hartv. Peabody Coal Co. , 537 U. S. 149, 168 (2003). Ex

pres sio unius, exclusio alte rius

. B The dissen t ’s principa l textual argument is mistaken

. We agree with its premise that “ ‘side effects that we re unavoidable’ must refer to side effects caused by a vac

cine’s desig n . ” 37

### We do not comprehend, however, th e second step of its reasoning, which is that the use of the conditional term “if ” in the introductory ph rase “if the injury ord e ath resulted from sid e effects th at were un

avoidable” “plainly implies that some side effects stem

ming from a vaccine’s design are ‘unavoidable,’ while

—————— We dou b t th a tCon g r e ss w o u l d in tr odu c e su c hanamor ph ou s test by implica t ion when it otherwise mi crom a n a ges va ccine m a nufa c t u rer s . See infra , at 13– 14. We h av en oideah o w mu c hmor eex pen s iv e a n a l t e rna t ive des i gn ca n b e before it“ c omprom is [es ] ” a va ccine’s cos tor how m u ch effica cy a na l t e rna t ive des i gn ca n s a crifice t o im prove s a fety. Neither does the dissent. And neithe r will the judges who must rule o n motions to d i smis s, mot i ons for summar yjudg ment, and motions fo r judg ment as ama tterof law

. Whic h mea n s thatthe te st would pr oba

bly have nore al-world effect.

36 W. Keeton, D. Dobbs, R. Keeton, & D. Owe n , Prosser andKeeton on Law of Tor t s 695 (5thed. 19 84); Rest atem en t (Th i r d) of Tor t s §2 (199 9 )

.

37 Post , at 3.9 Cite as: 56 2 U

. S. ____ (2011) Opinion of theCourt 

### others are avoidable.” 38 

### That is not so. The “if ” clause makes total sense whether the design to which “unavoid

able” refers is (as the dissent believes) any feasible design (making th e side effects of th e design used forthe vaccine at issue avo i dable), or ( a s we bel i e v e) the particular design used for the vaccine at issue (making its side effects un

avoidable). Under the latter view, the condition estab

lished by t h e “if” clau se is that the vaccine have bee n properly la beled and manufactured; and under the form er, that it have beenproperly design e d , labeled, and manufac

tured. Ne ither view renders the “if ” clause a nullit y. Which of the two varia n ts must b e preferred is addressed by our textual analysis, and is in no way de termined by the “if ” clause. Petitioners’ and the dissent’s textual argu ment also rests upon the proposition thatthe word “unavoidable” in §300aa–22(b)(1) is a term of art that incorporates com

ment kto Restatement (Second) of Torts §4 02A (1963– 1964). 39

### The Restatement generally holds a m anufacturer strictly liab l e for harm to person or property caused by “any produ ct in a defective condition unrea sonably dan

gerous to the user.” 40 

### Comment kexempts from this strict-liability rule “unavoid ably unsafe products.” An unavoidably unsafe product is defined by a h o dge-podge of criteria an d a few ex amples, such as the P a steur rabi es vaccine and experimental pharmaceuticals. Despite this lackof clarity, petitioners seize upon one phrase in the comment kanalysis, an d assert th at by 1986 a majority of courts had made this a sine qua non requirement for an “unavoidably unsafe product”: a ca se-specific showing tha t the productwas “quite incapable of being made safer for

——————

38 Ibid. 39 See Brief for Petitioners 29. 40 Restate m en t §402 A, p. 347.10 BRUE S EWIT Z v. WYETH LLC Opinion of theCourt 

### [its] intended . . . use.” 41



### We have noneed to consider the finer points of comment k

. Whatever consistent judicial gloss that comment may have been gi ven in 198 6, there is no reason t o believe th at §300aa–22(b)(1) was invoking it. The comment creates a special category of “un a voidably unsafe products,” whil e the statute refers to “side effects that were unavoidable.” That the latter uses the adjective “unavoidable” and the former the adverb “un a voidably” does not es tablish that Congress had comment kin m i nd. “Unavoidable” is hardly a ra rely used word. Even t h e cases petitioners cite as putting a definitive gloss on comment kus e the precis e phrase “un a voidably unsafe product”; 42 

### none attaches special significance to the term “unavoida ble” standing alone. The textualproblems with peti tio n ers’ interp retation do

——————

41 Id., Comment k , p. 353; Pe t i tion er s c i te, inter alia , Ke a r l v. Lederle Labs. , 172 Ca l. App. 3d 812, 828– 83 0, 218 Cal. Rptr

. 453, 463 –4 6 4 (198 5); Belle Bonfils Memorial Blood Bankv. Hansen , 665 P. 2d 1 1 8 , 122 (Colo. 1 9 8 3 ).

Though it is n o t pertinent t oour an aly s is , we poin t ou t th at a lar g e numberof c o ur ts di sag r eed with that r e a d ingof c o mment k , and took i t to say that m a nufacturers did not face st rict liab ility fo r side effects o f properly m a n u fa ct ured pre s cript ion drug s t h a twere a ccom p a n ied b y adequate warnings. See, e. g., Brownv. S u perio rCourt , 22 7 C a l. Rp tr
. 768, 77 2– 775 (Cal. App. 198 6), (offic i allydepu blish e d), aff’ d 44 Cal. 3d 104 9, 75 1 P. 2d 47 0 (1 988) ; McKe ev. Moore , 648 P. 2d 21, 23 (Okl a. 198 2); Stonev. Sm ith, Kli n e & F r e n ch Lab s . , 447 So. 2d 130 1, 130 3– 130 4 (Al a . 19 84); Lindsayv. Ort h o Pharm. Corp. , 637 F. 2d 87, 90 –9 1 (CA2 1980) (applying N. Y. law); Wolfgrub e rv. Upjohn Co. , 72 App. Div

. 2d 5 9 , 61, 4 23 N. Y

. S. 2d 95, 96 (1 97 9); Cham b ers v. G

. D. Searle& Co. , 441 F. Su pp. 377, 38 0–3 81 (D M d

. 197 5); Baskov. Sterling Dr ug, In c . , 416 F. 2d 41 7, 425 (C A2 19 69 ) (apply i n gCon n . law).

42 See, e. g . , Jo h n sonv. Ameri c an Cyanami dCo. , 239 Kan

. 279, 285, 718 P. 2d 1 3 1 8 , 132 3 (19 8 6 ) ; Feldmanv. Lederle Labs. , 97 N. J. 429 , 440, 4 4 6–44 7, 479 A. 2d 37 4, 380, 3 8 3 –38 4 (198 4); Belle Bonfils Memo

rial Blood Ba nk supra , at 121 –1 23; Cass isiv. Maytag Co. , 396 S o . 2d 114 0, 11 44, n
. 4, 114 6 (Fla. App. 198 1); Racerv. Utte rman , 629 S. W. 2 d 387, 39 3 (M o. App. 198 1).11 Cite as: 56 2 U

. S. ____ (2011) Opinion of theCourt 

### not end there. The phrase “even though” in the clause “even though the vaccine was properly prepared and [labeled]” is meant to s i gnal the unexpected: unavoidable side effects persist despitebest m anufacturin gand label

ing practices. 43

### But p e titioners’ reading eliminates any opposition between the “even though” clause—called a concessive subordinate clause by grammaria n s—and the word “unavoidable.” 44

### Their reading mak e s preemption turn equally on unavo i dability, proper preparation, and proper labeling. Thus, the dissent t w ice re fers to the requiremen t s of proper prepar ation and proper labeling as “two additional prerequisites” for preemption independent of unavoidability. 45

### The primary te xtual justifi c ation for the dissent’s positiondepends on that independence. 46 

### But linking independent ideas is the job of acoordinating junction like “and,” not a subordinating juncti on like “even though.” 47

——————

43 The dissent’ s asser t ion th atwe tr eat “ev e n though” as a sy nony m for“bec au se” misses th e su btle di s t inc t ion between “bec ause” a n d “despi te.” See post, at 17, n

. 14. “ Even though” is a close cousin of the latter

. See Webster ’ s New In ter n ation a l Dic t ion a r y709, 2631 (2d e d

. 195 7). Th e s t ate m en t “th e c a rac c i den twas u n av o idab le des p ite h i s quic k r e flex es” indic a tes th at quic k reflexes could not avoid the acci

dent, a n d leaves open two uns ta ted poss ib ilities : (1 ) tha tother, un

stated means of avoiding th e accide nt b e sides quick reflexes existed, but c a me up shor t as well; or(2) that quick reflexes were the only possi ble way to avoidthe accident. Our interpretati on of §300aa– 22(b)( 1 ) ex pla i n s wh ywe th in k Co ng r e ss me ant the lat t erin thi s context. (Inci d entally, the state m en t“t he ca r a ccidentwa s unavoidab le because of his quick reflexes” makes no sense.)

44 See W. Follett, M o dernAmer ic anUsag e: A Gu ide 61 (196 6). 45 Post , at 9, 17. 46 Post , at 3–5. 47 The dissent re sponds that these “a ddi tional prerequisite s” act “in a c o n c essiv e , su bor d in atin gfa sh ion , ” post, at 1 7 , n . 14 (in t er n a l qu otat io n mar k s and br ac kets omi tte d). But thati s n om o r et r u eo f t h ed i s s e n t ’ s conj un ct ive in t e rpret a t i on of t h e present te xt than i ti s of all provisions th at se t for t haddit i on al r e qu ir emen ts— m ean i n gth at we c o u l d elimi

nate “ev e n though” fr om our English le xicon, its function being entirely12 BRUE S EWIT Z v. WYETH LLC Opinion of theCourt 

### Petitioners and the dissent contend that the interpreta

tion we propose would render part of §300aa–22(b)(1) superfluous: Congress could have more tersely and more clearly pree mpted desi gn-defect claims by barring liability “if . . . the vaccine was properly prepared and was acco m panied by proper directions and warnings.” The interven

ing passage (“the injury or deat h resulted from side effects that were u navoidable even though”) is unnecessary. Tru e enough. But the rule against gi ving a portion of text an interpretati on which r e nders it s u perfluous does not pr e scribe that a passage which could have been more ter s e does not m e an what it says. The rule applies only if ver

bosity and prolixity ca n be elimin ated by giving the offen d

ing passag e , or the remainder of the text, a competin g interpretati on. Thatis not the c a se here. 48 

### T o b e s u r e , petitioners’ and the dissent’s interpretatio ngives in de

pendent meaning to the intervening passage (t he supposed meaning of comment k); but it does so only at t h e expense of renderin g the remainder of th e provisionsuperfluou s. Since a va ccine is not “quite incapable of bein g made safe r for [its] intended use” if manufacturing defects could ha ve been e limi nated or better warnings provide d , the enti re “even though” clause is a us eless appendage. 49

### I tw o u l d suffice to s a y “if the i n juryor de ath resulted from sid e effects that were unavoidable”—full stop.

—————— performed by “and.” No, we thin k “ev e n though” has a di stinc t iv e conces s ive, s ub o rdina t ing ro le t opla y .

48 Because the d i ssenthas a s u perfluity pro b lem of it s ow n, its reli

ance on Batesv. Dow Ag ros c ien c e s LLC, 544 U. S. 431 (200 5), is m i s placed. See id

. , at 449 (adoptin ganin ter p r e tationth at was “th e on ly one that makes sense of each ph r a se” in the r e lev a nt statute).

49 Th at is tr u er e g a r d less of wh eth e r§300aa– 22(b)( 1 ) in c o r p or ates c o mment k

. S ee Res t ate m e n t §40 2 A, Co mment k , pp. 353, 35 4 (n oti n g th at “u n av o id ablyu n s afe p r odu c ts” ar e exempt from strict li abil i ty “withth e qu al ific ationth at th eyar e prop erly prepared and marketed , and proper wa rning is given” ).13 Cite as: 56 2 U

. S. ____ (2011) Opinion of theCourt 

### III The structu re of the NCVIA and o f vaccine re gulation in general reinforces what the text of §300aa–22(b)(1) sug

gests. A vaccine’s license spells out the m anufacturin g method that must be followed and the directions and warnings t hat must a ccompany t h e product. 50 

### Manufac

turers ordi narily must obtain the Food and Drug Admini

stration’s (FDA) ap pr oval before modifying either. 51 

### D e viations from the license thus provide objective evidence of manufacturing defects or inadequate warnin gs. Furthe r objective evidence comes from the FDA’ s regulations— more than 90 of them 52

### —that pe rvasively r e gulate the manufacturing process, downto the requirements for plumbing a n d ventilati on systems at eachm anufacturin g facility. 53

### M a terial noncompliance with any one of them, or with any other FDA regulation, could cost the manufac

turer its re gulatory-co m pliance defense. 54 

### Design defects, in cont rast, do notmerit a si ngle men

tion in the NCVIA or the FDA’s regulations. Indeed, th e FDA has never even spelled ou t in regulations the criteria it uses to decide whether a va ccine is safe and effective for its intended use. 55

### An dthe decision is surely not an easy one. Drug manufacturers often could trade a little les s efficacy for a little mor e safety , bu t the safest design is not always the best one. Stri king th e right balance between safety and efficacy is especia lly difficult wi th respect to vaccines, which affect public as well as individual health. Yet the Act, which in every other respect mi cromanages manufacturers, is silent on how to evaluate competin g designs. Are manufacturers liable only for f a iling to em

-

——————

50 See 42 U. S. C. §262(a), ( j); 21 CFR §§60 1 .2 (a), 314.10 5(b) (2010). 51 See §601.12. 52 See §§211.1 et seq
. , 600.10– 6 00.15, 6 00.21

– 600.2 2 , 820.1 et s e q . 53 See §§211.46, 211.4 8

. 54 See 42 U. S. C. §300aa–2 2(b) (2). 55 Hutt, Merrill, & Grossman, Foodand DrugLaw, at 685, 891.14 BRUE S EWIT Z v. WYETH LLC Opinion of theCourt 

### ploy an alternative design t hat the FDA has a pproved for distribution (an approval it takes years to ob tain 56

### )? Or does it suffice that a vaccine design has been approved in other count ries? Or could ther e be liability for failure to use a design that exists only in a lab? Neither the Act no r the FDA regulations provide an answer, leaving the uni

verse of alternative designs to be limited only by an ex

pert’s imagi nation. Jurors, of course, often decide similar ques t ions with little guidance, and we do not s u ggest that the absen ce of guidance alone suggests preemption. But the lackof guidance f o r design defects co mbined with the ext e nsive guidance for the two grounds of liab ility specifically mentioned i nthe Act strongly suggests that de sign defects were not mentioned because they are not a basis for liability. The manda t es contained in the Act lead to the same conclusion. Design-d efect to rts, broadly speak i ng, have two beneficial effects: (1) pr ompti n g the development of improved designs, and (2) providing compensation f o r inflicted injuries. The NCVIA provides other means for achieving both effects. We have already discussed the Act’s generous compensation scheme. And the Act pro

vides many means of improving vaccine design. It directs the Secreta ry of Healt hand Hum an Services to promote “the development of childhood vaccines th at result i n fewer and less serious adverse reactions.” 57

### It establishes a National Vaccine Pro gram, whos e Director is “to achieve optimal prevention of h u man infectious disea s e s . . . and to achieve optimal prevention against adverse reactions.” 58 

### The Progra m is to setpriori ties for federal vaccine re

search, andto coordin a te federal vaccine saf e ty and effi

-

——————

56 See Sing & Willia m, Supplying Vaccines, at 66– 67. 57 42 U. S. C. §300a a– 27(a)( 1 ). 58 §300a a–1.15 Cite as: 56 2 U

. S. ____ (2011) Opinion of theCourt 

### cacy testing. 59

### The Ac t requires vaccine ma nufacturers and health-care providers to report adverse si de effects, 60 

### and provid es for monitoring of vaccine safety througha collaboration with eight manage d -care organizations. 61 

### And of course whenever the FDA concludes that a va ccine is unsafe, itmay revoke the licens e . 62 

### These provisions for federal agency impro v ement of vaccine des i gn, and forfederally p r escribed co mpensation, once again suggest tha t§300aa–22(b)(1)’s silence regard

ing design-defect liability was not inadvertent. It instea d reflects a sensible choice to leave complex epi d emiologica l judgments about vacci ne design to the FDA and the Na

tional Vaccine Program rather tha njuries. 63 

### And finally, the Act ’ s structu ral quid pro quoleads to the same conclusion: The vacci ne manufacturers fun d from their sales an informal, efficient compensation pr o gram for v a ccine injuries; 64

### in exchange they avoid costly tort litigation and the occasi onal disproportionate jury verdict. 65 

### But design -defect allegations are the mos t speculative and difficult type of products liability claim to

——————

59 See §§300a a– 2(a)(1)–( 3 ), 30 0aa–3. 60 See §300a a– 2 5 (b). 61 See NVAC 18–19. 62 See 21 CFR § 601.5(b)(1)(v i) (201 0). 63 The dissent quotes just p a rt of this senten c e , to make it appeartha t we believe co mplex epidem iological ju dg ments ough t to be assig n ed in t h a tf a s h i o n . S e e post , at 26. We do not state our p r eference, but mer e lynote that it i s Cong r e ss’ s ex pressed preference—and in order to pr ec lu de th e ar g u men tth at it is abs ur d to think Cong r e s s enac ted suc h a thing , we a s s er t tha t the c h oic eis reaso n able and exp r ess so me of the r e ason s wh y . Leav in git to t h e ju r ymay(ormayn o t) be r e ason able as well; we e x pre s s no view.

64 See 42 U. S. C. §300 aa–1 5( i)(2); Pu b. L. 99– 66 0, §32 3 ( a), 10 0 S t at. 3 7 8 4
. The dis s e nt’s uns upported s p ecula t ion that dema nd in the vaccine market is inelastic , see post , at24, n

. 22, sh eds n ol i gh t on whet her Co ngres s rega rded t h e t a x a s a quid proq u o , m o st M e mber s o f Congres s b e ing neitherprof es s i ona l economists nor law-and-economics sc h o lar s .

65 See 42 U. S. C. §§300aa–1 1( a)(2), 300 aa–2 2.16 BRUE S EWIT Z v. WYETH LLC Opinion of theCourt 

### litigate. Taxing vaccine manufa cturers’ pro d uct to fun d the compensation program, while leaving their liability for design defect virtual ly unal tered, would hardly coax manufacturers back into the market. The dissentbeli eves th e Act’s mandates are irrelevant because they do not sp ur innovation in precis ely the sam e way as state-law tort systems. 66

### That is a n o vel sugges

tion. Although we previously have expresseddoubt that Congress would quietl ypreempt product-liability claims without pro viding a federal substitute, see Me dtronic, Inc. v. Lohr , 51 8 U. S. 470, 486–488 (1 996) (plurality opinion), we have ne ver suggested we would be sk eptical of preemp

tion unless the congressional substitute operated like the tort system
. We decline to adopt that stanc e today. The dissent’s belief that the FDA and the National Vaccine Program ca nnot alone spur adequate vaccine innovation is probably questionable, but surely beside the point. IV Since our interpretati on of §300a a–22(b)(1) is the only interpretati on supported by th e text andstru cture of the NCVIA, e v en those of us who belie ve legislative history is a legitimate tool of statutor y in t e rpretation have no n eed to resort to it. In an y c a se, the dissent’s conte n tion that i t would contr a dict our co nclusion is mistaken. The dissent ’s legislative history relies onthe fol l owing syllogism: A 1986 House Committee Report states tha t §300aa–22(b)(1) “sets forth the principle contained in Comment k of Section 402A of th e Restatement of Torts (Second);” 67

### in 1986 comment kwas “commonly under

stood” to re quire a cas e -specific showing tha t“no feasible alternative design” existed; Congre ss thereforemust have intended §300aa–22(b)(1) to require that showing. 68

### T h e

——————

66 See post , at 21–24. 67 H. R. Rep. No. 99–9 08, pt. 1, p. 25 (198 6) (h er ein a fter198 6 Repor t). 68 Post , at 7–8.17 Cite as: 56 2 U

. S. ____ (2011) Opinion of theCourt 

### syllogism ignores unhelpful statements in the Report and relies upon a term of art that did n o t exist in 1986. Immediately after the language quoted by the dissent, the 1986 Report notes the difficul t y a jury would have in faithfully assessing whether a fe asible alter native design exists when an innocent “young ch ild, often badly injure d or killed” is the plaintiff. 69 

### Eliminating that concern is why the R e port’s aut hors “strongly believ[e] that Com

ment k is appropriate and necess ary as the policy for civil actions seeking damag e s in tort.” 70 

### The dissent’s interpre

tation of §300aa–22(b)(1) and its version of “the principle in Commen tK” a d opted by the 1986 Report leave tha t concern unaddressed. The dissentburies an other unfavorable piece of legis l a tive history. Because the Report believes t hat §300aa– 22(b)(1) should incorporate “the pr inciple in C o mment K” and because the Act provides a generous no-fault compen

sation scheme, the Report counsels injured parties who cannot prove a manufacturing or l abeling defect to “pu r su e recompense in the co mpensation system, n o t the tort system.” 71 

### That counsel echoes our interpretation of §300aa–22(b)(1). Not to wor r y , the dissent re torts, aCommittee Report b y a later Congress “auth o ritative[l y] ” vindicates its interpre

tation. 72 

### Post-enactment legislative history (a contradic

tion in terms) is not a legitima te tool of statutory interp re tation. See Jonesv. United Sta t es , 526 U. S. 227, 238

——————

69 1986 Re por t , at 2 6 ; see ibid. (“[E]ven if the de fendant ma nufac tur e r mayh av emade as safe a v a c c i n eas an y o n er e ason ablyc o u l d ex pec t , a court or jury undoubtedly will find itdi fficult to rule in favor of t h e ‘innoce nt’ ma nufa c ture r if the eq ua lly ‘innoce nt’ c h ild ha s to b e a rthe ris kof los s with no othe r pos s ibi lity of reco mpense”).

70 Ibid. 71 Ibid. 72 Post , at 12. Th is is a c o u r ag eou s adv e rb sin c e we h av epr ev iou s ly held that the onlyauthor itative source of statutory meaning is the text tha tha s pas s e d through the Article I proce ss. See Exxon Mobil Corp. v. Allapattah Se r v ices , In c. , 545 U. S. 546, 568 (2005).18 BRUE S EWIT Z v. WYETH LLC Opinion of theCourt 

### (1999); Uni t ed S t a t es v. Mine Wor k ers , 330 U. S. 258, 281– 282 (1947). Real (pre-enactment) legislative history is persuasive to some because it is thought to s h ed light o n what legislators understood an a m biguous statutory te xt to mean when they voted to enact it into law. See Exxon Mobil Corp. v. Allapa ttah Servi c es, Inc. , 545 U. S. 546, 568 (2005). Bu t post-enactment legis l ative history by defini

tion “could have had n o effect on the congressional vote,” D i st r i ctof C o lumbiav. Heller , 55 4 U. S. 570, 605 (2008). It does notmatter that §300aa– 22(b)(1) did not take effect until the later Congress passed the excise tax that funds the compensation scheme, 73

### and that the supposedly dispositive Committee Report is a ttached to t hat funding legislation. 74

### Those who voted on the relevant statutory language were not necessarily the same persons who crafted the statements in the later Committee Report; or if they were d i d not necessarily have the same views at that earlier time; and no one voting at that earlier time could possibly have been inf o rmed by those later statements. Permitting the legislative history of subseq uent funding legislation to alter the meaning of a statute would set a dangerous precedent. Many pro visions of federal law depend on appropriati o ns orinclude sunset provisions; 75 

### they cannot be made the device for unenacted statutory revision. That brings us to the s e cond flaw in the dissent’s syllo

gism: Comment kdid not have a “commonly understo o d meaning” 76

### in the mid-1980’s. So me courts thought it required a case-specific showing t hat a prod uct was “u n avoidably unsafe”; many others thought itcategorical l y exempted certain types of products from strict liability. 77

——————

73 Pu b. L. 99–96 0, §323(a), 1 0 0 Stat. 3 784. 74 H. R. Rep. No. 100– 39 1, pt. 1, p. 701 (1987). 75 See, e.g. , Pu b. L. 10 4–2 08, §§40 1 , 4 03( a) , 110 S t at. 3 009 –6 55 to 300 9– 656, 30 0 9–6 59 to 30 09 –66 2, a s am en ded, n o te follo win g8 U. S. C. §132 4a (2 006 ed., Supp. III) (E-Verify program expires Sept. 30, 201 2).

76 Post , at 8. 77 See n. 39, sup r a; post , at 7–8, n

. 5.19 Cite as: 56 2 U

. S. ____ (2011) Opinion of theCourt 

### When “all (or nearly all) of the” re levant judicial decision s have given a term or co ncept a co n s istent judicial gloss, we presume Congress intended the term or concept to hav e that meaning when it incorporated it into a l a ter-enacte d statute. Me rck & Co. v. Reynolds , 559 U. S. ___, ___ (2010) (S CALI A 

### , J., concurring in part and concurri ng in judg

ment) (slip op., at 5). The cons istent gloss represents the publi c u n de rst a n din g o f the te r m . We ca n n ot ma ke t h e same assu mption when widespread disagreement exis ts among the lower courts

. We mu st make do wi th giving the term its m o st plausible meaning using the tradi tional tools of statutory inte rpretation. That is what we hav e done today. * * * For the for e going reasons, we hold that the National Childhood Vaccine Injury Act preempts all design-defect claims against vaccine manufactu rers brought by plain

tiffs who seekcompensation for injury or death caused by vaccine side effects. Th e judg ment of the Court of Appeals is affirmed. It is so orde red. J USTICE 

### K AGAN

### took no part i nthe cons ideration or decision of t h is case._________________

_________________ 1 Cite as: 56 2 U

. S. ____ (2011) B REYER , J ., concu rrin g 

# SUPREME CO URT O FTHE UNI TED STATES
No. 09–1 52 

### RUSSEL L BRU ESEW ITZ, ET AL 

### ., PETITIONERS v. WYETH LL C, FKA 

### WYETH, INC., FKA 

### WYETH LAB O RAT O RIE S , ET AL


### . ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEAL S FOR THE THIRD CIRCUIT [Febr u ar y22, 2011] 

### J USTICE 

### B RE YE R 

### , concu rring. I join the Court’s judgment and opinion. In my view, the Court has the better of the purely textu a l argument. But the te xtual question considered alone is a clos e one. H e nce, lik e the dissent, I would lo okto othe r sources, in cluding legislative his t ory, statutory purpos e, and the views of the f e deral administrative agency, her e supported b yexpert m e dical opinion. Unlike the dissent, however, I believethese ot hersources reinforce the Court’s con c lusion. I House Committee Report 99–908 contains an “authori

tative” a cco unt of Con gress’ inte nt in d r aft i ng the p r e emption clause of the National Childhood Vaccine Injury Act of 1986 (NCVI A or Act). See Gar c iav. Unit e dSt at es , 469 U. S. 70, 76 (1984) (“[T]he authoritative source for finding the Legislature’s intent lies in the Committee Reports on the bill”). That Report says that, “if” vaccine

injured persons “cannot demonstrate under applicable law either that a vaccine was improperly prepare dor that it was ac

companied by impro p er directi ons or inadequate warnings [ t hey] should pursue recompense in the2 BRUE S EWIT Z v. WYETH LLC B REYER , J ., concu rrin g 

### compensation system, not the tort system.” H. R. Rep. No. 99–908, pt. 1, p. 24 (1986) (hereinafter H. R. Rep.). The Reportlists two specific kind s of tort suits that the clause does not pre-empt (sui ts based on improper manu

facturing and imprope rlabeling), while going on to state that compe n sation for other tort c l aims, e.g. , design-defect claims, lies in “the [NCVIA’s no-f ault] compensation sys

tem, not the tort system.” Ibid. The strong est contrar yargumen trests upon the Re

port’s earlier description of the st atute as “set[ting] fort h the princip l e contained in Comm ent k” (of the Restate

ment Second of Torts’ strict liabili ty section, 4 02A) that “a vaccine manufacturer should no t be liab l e for injuries or deaths resulting from unavoidableside effects.” Id. , a t23 (emphasis added). But the appearance of the word “un

avoidable” in this last-menti oned sentence cannot provide petitioners with much help. That is because nothing in the Report suggests that the s t atute means the word “unavoidable” to sum m on up anotherwise unmentioned third exception encom p assing sui t s based on design de

fects. Nor c an the Rep o rt’s refere nce to com m ent kfill the gap. The Report itself refers, not to comment k ’s details, but only to its “ princi ple, ” namely, that vaccine manufa c turers should notbe h e ld liable f o r unavoidable injuries. It says nothing at all about who—judge, ju ry, or federal safety age n cy—should decide whether asafer vac c ine could have been design ed. Indeed, at the ti me Congres s wrote this Report, diff erent state courts had come to ver y different conclusions about that matter. See Cupp, Re

thinking Conscious Design Li ability for Prescripti o n Drugs: The Resta t eme n t (Third) Standard Versus a Negli

gence Approach, 63 Geo. Wash. L. Rev. 76, 79 (1994–1995) (“[C]ourts [had] adopted a broad range of conf licting inter

pretations” of comment k). Neither the word “una void

-3 Cite as: 56 2 U

. S. ____ (2011) B REYER , J ., concu rrin g 

### able” nor the phrase “the princi ple o f Co mment k” te lls us which cour ts’ view Co ngress intended to ad opt. Silenc e cannot tell us to followthose States where ju ries decided the design-defect question. II The legisla t ive history describes t h e statute more gen erally as tr ying to p r otect the liv es of children, in part by ending “the instability and unpredictability of the childhood vaccine mark et.” H

. R. Rep., at 7; see ante, at 2–3. As the Committee Report makes clear, routine vacci

nation is “ o ne of the most spect a cularly eff e ctive public health initiatives this country has ever undertaken

. ” H

. R. Rep., at 4. Before the develo pment of routine whoo p ing cough vaccination, for examp l e, “nearly all children” in the United States caught the disease an d more than 4,000 people died ann ually, mostof them in fants. U. S. Dept. of He alth and Human Servi c es, Centers for Disease Control and Preventi on, What Would Happen if W e Stopped Vaccinations? http://www.cdc.gov/vaccines/v ac-gen/ whatifstop. h tm (all Internet materials as visited Feb. 17, 2011, and available in Clerk of Co urt’s case fi le); Prevent

ing Tetanus, Diphtheria, and Pertussis Among Adoles

cents: Use of Tetanus Toxoid , Re duced Diptheria Toxoid and Acellular Pertussis Vaccines, 55 Morbidity and Mor

tality Weekly Report, No. RR–3, p. 2 (Mar. 24, 2006) (here

inafter Preventing Tetanus) (statistics for 1934–1943), http://www.cdc.go v/mmwr/PDF/rr/rr5503.pdf; U. S. Dept. of Health and Human Services, Centers for Disease Con

trol and Prevention, Epidemiolo gy and Prevention of Vaccine-Pre ventable Diseases 20 0 (11th ed. rev. May 2009). After vaccinati o n became common, the number of annual cas e s of whooping cough declinedfrom over 200,000 to about 2,300, and the number of deaths fro m about 4,000 to about 12. Preventin gTetanus 2 ; Childhood Immunizations, H o useCommittee on Energy and Com

-4 BRUE S EWIT Z v. WYETH LLC B REYER , J ., concu rrin g 

### merce, 99thCong., 2d Sess., 10 (Comm. Print 1986) (here

inafter Childhood Imm unizations). But these gains are fragile; “[t]he causative agents for these preventable chil dhood illn esses are ever present in the environment, waiting for th e opportunity to atta ck the unprotected individual.” Hearing on S. 827 before the Senate Committee on Labor and Human Resources, 99th Cong., 2d Sess., pt. 2, pp. 20–21 (1985) (hereinafter Hear

ings) (testimony of the American Academy of Pediatrics); see Calif ornia Dept. of Public Health, Pertussis Report (Jan. 7, 2011), www.cdph. c a.gov/program s /immunize/ Documents/PertussisReport2011–01–07.pdf (In 2010, 8,383 people in California caught whooping cough, and 1 0 infants died). Even a brief period when vaccination pro

grams are disrupted can lead to children’s deaths. Hear

ings 20–21; see Gangarosa et al., Impact of Anti-Vaccine Movements on Pertussis Control: The Untold Story, 351 Lancet 356–361 (Jan. 31, 1998) (when vaccination pro

grams are disrupted, the number of cases of whooping cough skyrockets, incre asing by orders of magnitude). In considering the NCVIA, Congress found that a sharp increase in tort suits brought agai nst whooping cough and other vacci ne manufacturers between 1980 and 1985 ha d “prompted manufacturers to question th eir continued participatio nin the vaccine market.” H. R

. Rep., at 4; Childhood Immunizations 85–86. Indeed, t w o whooping cough va cci ne manufacturers with drew from the market, and other vaccine manufacturers, “fac[ing] great difficulty in obtainin g [product liability] in surance,” told Congres s that they were considering “a s i milar course of action.” H. R. Rep., at 4; Chil dhood Immunizations 68–70. The Committee Report explains that, si nce there were only on e or two manufacturers of many childhood vaccines, “[t]he loss of anyof the existing man u facturers of childhood vaccines .

. . could crea t e a genuine public health hazard”; it “would present the very real pos s ibility of vaccine short

-5 Cite as: 56 2 U

. S. ____ (2011) B REYER , J ., concu rrin g 

### ages, and, in turn, increasing numbers of unimmunized children, and, perhaps, a resurgence of preventable dis

eases.” H. R. Rep., at 5. At the same tim e , Congress sought to provide generous compensation to those whom vaccines injured—as d e termined by an expert compensa

tion program. Id., at 5 , 24. Given these broad ge neral purposes, to read the pre

emption cl ause as preserving design-defect suits seem s anomalous. The Department of Health and Huma n Services (HH S ) decides when a va ccine is saf e enough t o be licensedand which licensedvaccines, with whi c h associated injuries, should be placed on the Vaccine I n jury Table. 42 U. S. C. §300aa–14; ante, at 3–4; A Comprehensive Review of Federal Vaccine Safety Pro

grams an d Public Health Activities 13–15, 32–34 (Dec. 200 8), http://www.hhs.gov/nvpo/nva c/documents/ vaccine-safety-review.pdf. A spe c ial master in the Act’s compensation program determines whether someone h a s suffered an injury listed on the Injury Table and, if not, whether th e vaccine n o netheless caused the injury. Ante, at 3–4; §300aa–13. To allow a jury in effect to secon d

guess those determinations is to substitute less expert for more expert judgment, thereby threatening manufacturers with liability (indeed, strict liability) in instances where any conflict between experts and n o nexperts is likely to b e particularlysevere—instances where Congress intende d the contrary. That is because pot e ntial tort plaintiffs are unlikely to bring suit unless the s p ecialized compensation program h a s determined that t h ey are not entitled to compensation (say, because it concludes that the vacci n e did not cause the injury). Brie f for Unite dS t ates a s Amicus Cu riae28 (“9 9 .8% of successful Compensation Program cl aimants have accepted their awards, foregoin g any tort re medies against vacci n e manufacturers”). It is difficult to reconcile these po tential conflicts and the re

sulting tort liabiliti e s with a st atute that seeks to diminish6 BRUE S EWIT Z v. WYETH LLC B REYER , J ., concu rrin g 

### manufacturers’ product liability while simultaneous l y augmentingthe role of experts in making co mpensation decisions. III The United States, reflecting the views of HH S, urges the Court t o read the Act as I and the majority would d o . It notes that the compensation program’s lis ted vac c ines have survi v ed rigorou s administrative safetyreview. I t says that to read the Act as permittingdesign-defect lawsuits could lead to a recurren c e of “exact ly the crisis that precipi t ated the Act,” namely withdra w al s of vaccines or vaccine manufacturers from th e market, “disserv[ing] the Act’s central purpo s es,” and hampering the ability of the agency’s “expert r e gulato rs, in conjunction with the medical community, [ t o] control t h e availability and wi t h

drawal of a given va ccine.” Bri e f for United States as Amicus Cu riae30, 31. The United States is supported in this claim by leading public health organizations, including the Am erican Acad

emy of Pediatrics, the Amer ican Academy of Family Ph y sicians, the American College of Preventive Medicine, the American Public Health Association, the Am erican Medi

cal Association, the March of Dime s Foundation, the Pedi

atric Infect ious Diseases So ciety, and 15 other similar organizations. Brief for American Academy of Pediatrics et al. as Amici Curi ae(hereinafter AAP Brief). The Ameri

can Acade m y of Pediatrics has also suppor ted the reten

tion of vaccine manufa cturer tort liability (provided that federal law structured state-law liabi lity conditions i n ways that would take proper account of fed e ral agency views about safety). Hearings 1 4–15. But it nonetheless tells us here, in respec t to th e specific question before us, that the petitioners’ interpretatio nof the Act would un

dermine its basic purposes by threatening to “halt the future production and developmen t of childho od vaccines7 Cite as: 56 2 U

. S. ____ (2011) B REYER , J ., concu rrin g 

### in this country,” i.e., b y“threaten[i ng] a resur g ence of th e very problems which . . . caused Congress to intervene” b y enacting th is statute. AAP Brief 24 (internal quotation marks omit ted). I would give significant weight t o the view s of HHS

. The law charges HHS with re sponsibility for overseeing vaccine pro d uction andsafety. It is “likely to have a thor

ough understanding” of the complicated and technical subject matter of immunization policy, and it is compara

tively more “qualified to comprehend the likely impact of state requirements.” Geier v. Am erican Honda Motor Co., Inc. , 529 U. S. 861, 883 (2000) (in t ernal quotation marks omitted); se e Medtroni c, Inc. v. Lohr , 518 U. S. 470, 506 (1996) (B RE YER 

### , J., concurring in part and co ncurring in judgment) ( t he agency is in the best position to determine “whether (or the extent to which) state requirements may interfere with federal objective s”). HHS’s position is par

ticularly p e rsuasive here be cause expert public health organizations support its views and the matter concerns a medical and scientific question of great importance: how best to save the lives of children. See Skidmorev. Swift & Co. , 323 U. S. 134 (1944). In sum, con gressional r e ports and history, the statute’s basic purpose as revealed by t hat history, and the views of the expert a g ency alongwith those of relevant medical and scientific as sociations, all support the Court’s conclusions. I consequen t ly agree wi th the Court._________________

_________________ 1 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

# SUPREME CO URT O FTHE UNI TED STATES
No. 09–1 52 

### RUSSEL L BRU ESEW ITZ, ET AL 

### ., PETITIONERS v. WYETH LL C, FKA 

### WYETH, INC., FKA 

### WYETH LAB O RAT O RIE S , ET AL


### . ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEAL S FOR THE THIRD CIRCUIT [Febr u ar y22, 2011] 

### J USTICE 

### S OTOMAYOR 

### , with who m J USTICE 

### G INSB URG 

### joins, dissenting. Vaccine manufacturers have long been subjec t to a legal duty, rooted in basic principles of products liability law, to improve the designs of their vaccines in l i ght of advances in science and techno logy. Un ti l today, th at duty wa s enforceable througha traditional state-law to rt ac tion for defective design. In holding that §22(b)(1) of the National Childhood Vaccine Injury Act of 1 986 (Vaccin e Act or Act), 42 U. S. C. §300aa–22 (b)(1), pre-empts all design defect claims for i n juries stemming from vaccines covered under the Act, the Court imposes its o w n bare policy preference over the considered judgment of Congress. In doing so , the Court e x cises 13 words from t h e statutor y text, mis

construes the Act’s le gislative history, and disturbs th e careful balance Congr e ss struck between compensating vaccine-injured children and stabilizing the childhood vaccine ma rket. Its d e cision leav es a regulatory vacuu m in which no one ensures that va cci ne manufacturers ade

quately take account of scientificand technological ad

vancements when designing or distributing the i r products. Because nothing in the text, stru cture, or legislative his

tory of the Vaccine Ac t remo tely suggests that Congress intended such a result, I respectfully dissent.2 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### I A Section 22 of the Vaccine Act provides “[s]tandards of responsibility” to gov e rn civil actions against vaccin e manufacturers. 42 U. S. C. §300aa–22. Secti on 22(a) sets forth the “[g]eneral rule” that “St a te law shall apply to a civil action broughtf o r damage s for a vaccine-related injury or death.” §300aa–22(a). This baseline rule that state law a pplies is subject to th r ee narrow exceptions, one of which, §22(b)(1), is at issue in this case. Section 22(b)(1) provides: “No va ccine manufactu rer shall be liable in a civil ac

tion for da mages arising from a v a ccine-related injury or death as sociated wi th the adm i nistration of a vac

cine after October 1, 1988, if the injury or death re

sulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied byprop er directio n s and warnings.” §300aa–22(b)(1). The provision contains two key cl auses: “if the injury or death resulted from side effe cts that were u navoidable” (the “if ” cla u se), and “ e ven thoughthe va cci ne was pro p erly prepared and was accompanied by proper directions and warnin gs” (the “ev e n though” clause). Blackletter products liability law generally recognizes three differ e nt ty pes of product defects: de sign defect s, manufacturing defects, and labelin g defects ( e. g. , failure to warn). 1 

### Th e reference in the “ev e n though” clause to a “properly p r epared” va ccine “acco mpanied by proper direc

tions and warnings” i s an obvious reference to two such defects—m anufacturin gand labeling defects. The plain terms of the “even though” cla u se thus indicate th at

——————

1 W. Keeton , D. Dobbs , R. Ke eton, & D

. Ow en, P r os s e r an d Keeton o n Law of Tor t s 695 (5thed. 19 84).3 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### §22(b)(1) ap plies only where neither kind of defect is p r e sent. Because §22(b)( 1 ) is invoked by va ccin e manufactur

ers as a def e nse to tort liabili ty, it follows that the “even though” cla u se requires a vaccine manufactu rer in each civil action to demonstrate t hat its vaccine is free from manufacturing and la beling defects to fallwithin th e liability exemption of §22(b)(1). 2 

### Given thatthe “even though” cl ause requires the ab

sence of manufacturing and la beling defects, the “if ” clause’s reference to “ s ide effects that were unavoidable” must refer to side effec t s c aused by something other tha n manufacturing and lab e ling defects. The only remaining kind of p r oduct defectrecogn ized under traditional prod

ucts liability law is a design defect. Thus, “side effects that were u navoidable” must re fer to side effects caused b y a vaccine’s design th at were “unavoidable.” Because §22(b)(1) uses the conditional term “if,” moreover, the tex t plainly implies that some side effects stemm i ng from a vaccine’s de sign are “u navoidable, ” while others are avoid

able. See Webster’s Third New International Dictionary 1124 (2002) (“if ” means “in the eve n t that, ” “so long as,” or “on condition that”). Accordingly, because the “if ” clause (like the “even though ” clause) sets forth a condition to invoke §22(b)(1)’s defense to tort liability, Congress must also have in tended a vaccine manufacturer to demonstrate in each civ il action th at the part icular side effects of a vaccine’s de sign were “unavoidable.” Congress’ use of conditional “if ” clauses in two othe r provisions of the Vacci ne Act supp orts the conclusion that §22(b)(1) requires aninquiry in each case in which a manufacturer seeks to invoke the provision’s exception to

——————

2 See Silkwoodv. Ke rr -M cG ee Cor p . , 464 U. S. 23 8, 2 55 ( 1 984); Brown v. Earthboard Sports USA, Inc. , 481 F. 3d 901, 9 12 (C A6 20 0 7 ) (“ ‘[F]ederal preemption is an affi rmati v e defense upon which th e defendants be ar the burden of proof ’ ” (quoting Fifth Third Bank v. CSX Corp. , 415 F. 3d 741, 74 5 (CA7 2 005)))

.4 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### state tort liability. In §22(b)(2), Congress created a pre

sumption that, for purposes of §22(b)(1), “a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it com

plied in all material respe cts wit h” federal labeling re

quirements. 42 U. S. C. §300aa–22(b)(2). Similarly, in §23(d)(2), Congress created an exemption from punitive damages “[i]f . . . the m anufacturer shows that it complied , in all material respects,” with applicable federal laws, unless it engages in “fraud,” “in t entional and wrongfu l withholding of inf o rmation” from federal regulators, or “other crim i nal or illegal activity.” §300aa–23(d)(2). I t would be h i ghly anomalous for C o ngress to use a condi

tional “if ” clause in §§22(b)(2) and 23(d)(2) to require a specific inq u iry in eac hcase whil e using the same condi

tional “if ” clause in §22(b)(1) to denote a categorical ex

emption from liability. Cf. Erlen b aughv. Unit e dSt a t es , 409 U. S. 239, 243 (19 72) (“[A] legislative body generall y uses a particular word with a consistent meaning ina given context”). Indeed, when Congress intends to pre-empt design defect claims categor i cally, it d oes so using cate gorical ( e.g. , “all”) and/or declarative language (e.g. , “shall”), rather tha na conditional term (“if ”). For example, in a related c o ntext, Con gress has a u thorized t h e Secretar y of Health and Huma n Services to design ate a va cci ne designed to prevent a pandemic or epidemic as a “covered countermeasure.” 4 2 U. S. C. §§247d–6d(b), (i)(1), (i)(7)(A)(i). With respect to such“covered c o untermea

sure[s],” Co ngress prov ided that s ubject to certain excep

tions, “a covered perso n shall be immune from suit and liability un der Federal and State law with re spect to all claims for loss causedby, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure,” §2 47d–6d(a)(1) (emphasis added), including specifically claims relating to5 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### “the design” of the countermeasure, §247d–6d(a)(2)(B). The plain text and st r u cture of t h e Vaccine Act thu s compel the conclusion t hat §22(b)(1) pre-empts some—bu t not all—design defect claims. Contrary to t h e majority’s and respondent’s categ o rical reading, petitioners correctl y contend th at, where aplaintiff h a s proved that she has suffered an injury resulting from a side effect caused b y a vaccine’s design, a vaccinemanufacturer may invoke §22(b)(1)’s liability exemption on ly if it demonstrates that the side effect stemming from t h e particul a r vac c ine’s design is “unavoidable, ” and tha tthe vaccine is otherwis e free from manufacturin gand labeling defects. 3 

### B The legislative historyconfirms p e titioners’ interpreta

tion of §22(b)(1) and sheds further light on its pre-emptive scope. The H o use Energy and Commerce Committee Report acco mpanying t h e Vaccine Act, H. R. Rep. No. 99– 908, pt. 1 (1986) (hereinafter 1986 Report), explains in relevant part:

“ Subsection(b)—Unavoidable Ad verse Side Effects; Dire ct Wa r n ings .—Thi s provision sets forth the prin

ciple contained in Com m ent K of Section 402A of the Restatement of Torts ( S econd) that a vaccine manu

facturer sh ould not be liable for injuries or deaths re

sulting from unavoidable side eff e cts even though the vaccine was properly prepared and accompanied by proper dire ctions and warnings. “The Com m ittee has set forth C o mment K in this bill because it intends that the pri n ciple in Comment K rega rdin g ‘unavoida bly unsafe’ products, i. e., those products which in the present state of human skill and knowle dge cannot be made saf e , apply to the vac

-

——————

3 This leaves the question of whatpr ec isel y§22(b)(1) me an s by“u n av oidable ” sid eeffec t s, w h i c hI addr ess in th e n e x tsec t ion

.6 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### cines covered in the bill and that such products not be the subject of liability in the tort system.” Id. , at 25– 26. The Report expressly adopts comment kof §402A of the Restatement of Torts (Second) (1 963–1964) (hereinafter Restatement), whichprovides tha t“una voidably unsafe” products— i.e

. , those that “in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinar y use”—are not defective. 4

### A s “[a]n outstanding example” of a n“[u]navoidably unsafe” product, co mment kc i tes “the v a ccine for the Pasteu r treatment of rabies, which no t uncommonly leads to very serious anddamaging consequenc es when it is injected”;

——————

4 Comment kprovides as follows : “ Unavoidably unsaf e products

. There aresome products which, in the present state of human knowledg e, ar e qu ite in c a pable of bein g made safe fortheirintended and or dinary use. Theseare especiall y common in the field of drugs. An outstan d ing example is the vaccine for the Paste u r treatment of rabies , which not uncom m only leads t o verys e rious a n d da ma ging cons eq uences when it is injected. Sincethe disea s e it self i n v a r i ablylead s to a dr eadfu ldeath , botht h e mar k etin g and the use of the vaccine are fullyj u s t ified, notwiths ta nding the unavoidable high degree of risk which they involv e. Such a product , pr oper lypr epar ed, an d ac c o mpan ied byproper directions and warning, is not defective, nor is it unreaso nab l ydangero u s. The same i s true of ma ny other dr ugs , va cci nes , a n d the like, ma ny of whic h forthis very rea s on ca nnotlega lly b e s o ld exceptto p h ysicians, or under the pre

scription of a physician. It is also true inpa rticula rof ma ny new o r experimenta l drugs a s to which, b e ca us e of la ck of time and opportunity for s u fficient m e dica l experience, t h ere ca n b eno a s s u rance of s a fety, or perhaps even of purity of ingredient s, bu t su c hex per i e n ce as there is justifie s the marketing and use of th e dru gnotwiths ta nding amedica lly r e c o gn izable r i sk. Th e selle rof su c hpr odu c ts, ag ainwithth e qu alific a tion that they are prop erly prepared and marketed, and p r oper warning is given, whe r e the situation calls fo r it , is not to beheld to strict liab ility for unfortunate consequenc es attending their use, merely b e ca us e he h a s underta ken to s u pply the pub lic with a na ppa rently u s efu lan d de sir able pr odu c t, at te nded with aknown but a ppa rently r e ason able r i s k .” Restate m e n t 353– 35 4.Cite as: 56 2 U

. S. ____ (2011) 7 S OTOMAYOR , J., dissen t in g 

### “[s]ince the disease its e lf invariably leads to a dreadful death, both the marke t ing and th e use of the vaccine are fully justified, notwithstanding the unavoidable high degree of riskwhich they involve.” Id ., at 353. Comment kthus provides that “seller[s]” of “[u]navoidably unsafe” products are “not to be held to s trict liability” provided that such p r oducts “ar e prop erly prepared and mark ete d , and proper warning is given.” Ibid. As the 1986 Report explains, Congress intended that the “principle in Comment K re garding ‘unavoidably unsafe’ products” apply to the vaccines covered in the bill. 19 86 Report 26. That intent, in turn, is manifested in the plain text of §22(b)(1)—in pa rticular, Co ngress’ use of the word “unavoidable,” as well as the phra ses “properly prepared” and “acco mpanied by proper d i rections and warnin gs,” which were taken nearly verbati m from comment k

. 42 U. S. C. §300aa–22(b)(1); see Resta t ement 353–354 (“Such a[n unavoidably unsafe] product, properly prepared, an d accompanied by prope rdirection s and warning, is not defective”). By the tim e of the Vaccine Act’s e nactment in 1986, numerous state and federal courts had interpreted comment k to mean th at a product is “unavoi dably unsafe” when, give n proper m anufacture and labelin g, no feasib le alternative design would redu ce the safety risks without compromising the product’s cost and utility. 5 

### Given Con

-

——————

5 See, e. g. , Sm ith ex rel . Sm ith v. Wyet h L a bs., Inc

. , No. Civ

. A 84– 200 2, 198 6 WL 7207 92, *5 (SD W. Va., Aug

. 21, 1986) (“[A] pr esc r i ption drugis not ‘ u navoidab l y un s a fe’ whenits da ngers ca n b eelimina t e d through design changes that do not und uly affect its cost or utility”); Kearl v. Lederle Labs. , 172 Cal. Ap p. 3d 812, 830, 21 8 Cal. Rp tr
. 45 3 , 464 (1 985) (“ u n av o idabili ty” tu r n s on “(i) wh eth e rthe pr odu c t was desig n ed to mi nimize—to the ex tent scienti f ically knowable at the tim e it w a s d i str i b u ted—th e r i sk in h e r e n t in th e product, and (ii) the avail

abil i ty
. . . of an yalter n ati v e pr odu c t th at wou l d h av e as effectiv el y ac c o mplished the full intended purposeof the subjec t p r oduc t”), disa p proved in part byBrownv. Superio rCt. , 4 4Cal. 3d 104 9 , 751 P. 2d 470 (198 8); Belle Bonfils Memorial Blood Bank v. Hansen , 665 P. 2d 1 1 8 ,8 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### gress’ ex pre ssed intent to codifyth e “principle in Comment K,” 1986 Report 26, th e term “un a voidable” in §22(b)(1) is best understood as a term of art, which incorporates the commonly understood meaningof “unavoidably unsafe” products u n der comm ent kat th e time of th e Act ’ s enact

ment in 1986. See McDermo tt In t’l, Inc. v. Wilander , 4 98 U. S. 337, 342 (1991) (“[W]e assume that wh en a statute uses . . . a term [of art], Congress intended it to have i t s establishedmeaning”); Morisse ttev. Uni t edSta t es , 342 U. S. 246, 263 (1952) (same). 6

### Similarly, courts applyi ng

—————— 122 (Colo. 198 3) (“[A]p plicab ility of com m e n t k .

. . depends upon the co

existence of several factors,” includin gthat“the pr oduc t’ sbenefits must not b ea c hievab le in a n other ma nner; a n d the ris kmus tbe unavoidab l e under thepre s ent state of knowledg e”); see also 1 L. Frumer & M. Fr iedman , Produ c ts Liabil i t y§§8.07[1]–[ 2], pp. 8–277 to 8–2 78 (2 01 0) (c omment k a pplies “onlyto defec t s in de sig n ,” and the r e “must be no feasib le alter n ativ e desig nwh ic h on bala n c eacc o mplis h e s th e su bject pr odu c t’ s purpose w i tha lesserr i sk” (internal quotati o n marks omit

ted)). To be s u r e , a number of c o ur ts at t h e time of the Vac c i ne Ac t’ s enac tment had inter p r e ted c o mment kto preclude design defect claims ca t e gorica lly for cert a i n kin d s of product s , s ee Hill v. Se a r leL a bs

. , 8 84 F. 2d 106 4, 1 0 68 (C A8 198 9) (c ollec t in gc a ses), bu t as in dic a ted by th e sour c e s c i ted abov e , the c o ur ts thathad c o nstr ued c o mment kto a p p l y on aca s e -s pecific b a s is genera lly a g r eed o nthe basic elements of what cons tituted a n“unavoidab ly uns a f e” product. S e e a l s on . 8 , infra

. The major i ty ’ s sug g e stion that “j udg e s who must r u le on motions to dismis s, motions for summar yjudg m e nt, and mot i o n s forjudg ment as a ma tter of law” ar e in c a pab l e of adju dic a tin gc l aim s allegi n g“u n av o idable ” si d e effects, ante , at 7–8, n

. 35, is th u s belied b yth e ex per i enc eof th e many c o ur ts that had ad judic a te d suc hc l aims fory e ar s bythe time of th e Vac c i ne Ac t’ s enac tment.

6 The m a j o rit y refus e s t oreco gnize t h at “u nav o idable ” is ater mof ar t derived from comment k , sugges t ing t h a t“ ‘[u]navoidab l e’ is ha rdly a ra rely us ed word.” Ante , at 10. Infac t , h o wev e r , “u n av o idable” is a n extremely rare word in thereleva nt cont ext. It a ppears exa c tly once ( i.e. , in§300a a–2 2(b)(1)) inth e en tir e tyof Title 42 of th e U. S. Cod e (“Pu blicHealt han d Welfar e”), wh ic h g o ver n s, int er ali a , Soc i al Sec u r i ty , see 42 U. S. C. §301 et seq ., Medica re , s ee §1 39 5 et se q . , and s e veral other of the F e deral Government’s largest entitle m ent p r ograms. The s i ngula rra rityin whic h Co ngres s us ed th e term s u pp orts the con c lu

-9 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### comment khad long required manufacturers invokin g the defense to demonstrate t hat their products were not only “unavoidably unsa f e” but also properly manufacture d and labeled

. 7

### By requiring “p rope[r] prepa r [ a tion]” and “proper dir e ctions and warnings” in §22(b)(1), Congress plainly intended to inc o rporate these additional comment krequirements. The 1986 Report thu s confirms petitioners’ interpreta

tion of §22(b)(1). The Report makes clear that “side effec t s that were unavoidable” in §22(b)(1) refers to side effec t s stemming from a vacci ne’s desi gn that were “unavoidable.” By explaining what Congre ss meant by the term “un

avoidable,” moreover, the Repo rt also co nfirms tha t whether aside effec tis “unavoidable” for purposes of §22(b)(1) involves a specific inquiry in each case as to whether the vaccine “in the present state of human sk ill and knowledge cannot be made saf e ,” 1986 Report 26— i.e. , whether a feasible alt e rnative de sign existed thatwou l d have elim i nated the adverse side effects of the vaccine without co mpromising its cost and utility. See Brief for Kenneth W. Starr et al. as Amici Curiae 14– 15 (“If a pa r ticular plaintiff could show that her injury at issue was avoidable .

. . through the use of a feasib le alternative design for a specific vaccine, then she would satisfy the plain language of the statute, because she would have demonstrated that the side effects were notun avoidable”). Finally, the Report con f irms that t h e “even though” clause is properly read to establish two additional prerequisites

— proper manufacturing and proper labeling—to qualify for

—————— sionth at “u n av o idable” i s a t e r mof ar t.

7 See, e. g . , Brochuv. Ort h o P h arm a ceu tical Corp. , 642 F. 2d 652, 65 7 (CA1 19 81); Needham v. White Lab s ., Inc. , 639 F. 2 d39 4, 4 0 2 (C A7 198 1); Reyes v. Wyeth Lab s . , 498 F. 2d 126 4, 12 74– 1 275 (C A5 1 9 7 4); Davis v. Wyet h Labs. , 399 F. 2d 12 1, 1 2 7 –12 9 (C A9 19 68); Feldman v. Lede rle Lab s . , 97 N. J. 429, 448, 479 A. 2d374, 3 84 (198 4); see als o Toner v. Lederle Labs. , 112 Idah o 328, 33 6, 732 P. 2d 297, 305 (19 87).10 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### §22(b)(1)’s liability exemption. 8 

### In addition to the 1986 Report, one other piece of the Act’s legislative history provid es further confirmation of the petition ers’ textual reading of §22(b)(1). When Con

gress enacted the Vaccine Act in 1986, it did not initially include a source of pay m ent for th e no-fault compensation program th e Act established. The Act thus “made the compensation program and accompanyingtort reforms contingent on the enactment of a tax to pro vide fundin g

——————

8 Respon den ts u g g e sts anal ter n ativ e r e adin gof th e 1986 Repor t
. Accordingt or e s p ondent , “ t h e principle in Comment K” i s simp lythat of nonliab ility for “unavoidab l y uns a f e” pr oducts , a n d thus Congres s ’ sta t ed intenti nthe 19 86 Re por tto applyt h e “pr i nc iple i nComment K ” to “the vaccines covered in the bill” mea n s that Congress viewed the covered va c c in es as a cla s s to b e“ ‘unavoidab l y uns a f e.’ ” 1 986 Repor t 25– 26; Br ief forRespon den t42. Th e c o n c u r r e n c e makes a s i mi lar ar g u men t
. An t e , at 1–2 (opin i onof B REYER , J.). This inter p r e tation fin d s some su ppor tinth e 1986 Re por t , wh ic hstates th at “if [in j u r ed individua l s ] ca nnot demonstra t e und er applicable laweither that a vaccine was i m properly prepared ortha titwas accompanied by im

proper direct ions or ina d equa t ewa rnings [t hey] s h ould purs ue recom pense in the c o mpensation system, no t th e tor tsy s t em. ” 1 9 8 6Repor t 26. It al so fin d s so me su pp or t inth e pr e- Vac c i n eAc t c a se law , w h ic h reflected considerable di sagreement inthe courts over “w hether com

ment k applie s to phar mac e utic al pr oduc ts ac r o ss the b o ar d oronlyon a c a se- b y - c a se ba sis. ” Au sn ess, Un av oi dablyUn s a fe Pr odu c ts an d Strict Products Liab il ity: Wh at Liab il ity Rule Should b eAppliedto t h e Seller s of Ph ar mac e u t ic al Pr odu c ts? 78 Ky . L. J. 705, 708, an d n

. 11 (198 9–1 99 0) (collecting cases )

. This interp retation, however, is under

m i ned b yt h e fa ctt h a tCongres s ha s never direct ed t h e Food a n d Dru g Administratio n(FDA) or any other fe de ral agency to review vaccines for opt i m a l va ccine des i gn , s ee infra , at 20–2 2, an d n

. 1 9 , an d th u s it s eems highly unlikely tha t Congres s intended to elim i n ate the tr adi

tional mec h anism for suc hrev i ew ( i.e. , design defect liabili ty), particu

lar l ygiv e nits ex pr ess r e ten t ionof st ate tor tlaw in the Vaccine Act, see 42 U. S. C. §3 00a a– 22(a). I nan yev en t, to th e ex ten tth er e is a m big u i t y as to how pr ec iselyCong r e ss intended the “pr i nc iple in C o mment K” to a pply t ot h e covered va c c in es , t h a ta m bi guity is explicitly resolved in petitioner s’ fa v o rbythe 19 8 7 Ho use Energyand Comm erce Commit t e e Repor t , H. R. Rep. No. 100

– 391, pt

. 1, pp. 690 –6 91 (h er ein a fter198 7 Report). See inf r ath is pag e an d 11– 12.11 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### for the com p ensation.” 1987 Report 690. In 1987, Co n gress passed legislation to fund the compensation pro

gram. The H o use E n ergy and Commerce Committee Report 9

### accompanying that legislation specific ally stated that “the co dification of Comment (k) of The Restatement (Second) of Torts was n o t intended to decide as a matterof law the ci rcumstance s in which a vaccine should be deemed un avoidably unsafe.” Id. , at 691. The Committee noted that “[a]n amendment to establish .

. . that a manu

facturer ’ s f a ilure to develo p [a] safer vacci ne was not grounds for liability was rejecte d by the Committee duri ng its original consideration of the Act.” Ibid. I nl i gh to f t h a t rejection, the Committee emphasiz ed that “the r e should b e no misunderstanding that the Ac t undertook t o decide as a matter of l a w whether vaccines were unavoidably unsafe or not,” and that “[t]h i s question is left to t h e courts to determine in accordanc e with applicable law.” Ibid

. To be sure, postenactment le gislative history created b y a subsequent Congres s is ordina rily a hazardous basis from whichto infer th e intent of the enacting Cong ress. See Sullivanv. Fink els t ein , 496 U. S. 617, 631 –632 (1990) (S CALI A 

### , J. , concurrin gin pa rt). Bu t unlike ordinar y postenactment legislative history, which i s justifiably given little or no weight, th e 1 987 Report reflects the intent of th e Congress that enacte d the fundi n g legislation necessary to give operative effect to the principal prov i

sions of the Vaccine Act, including §22(b)(1). 10 

### Congress in

——————

9 The Third C i rcuit’s opinion belo w ex pressed unc er taintyas to wh eth e rth e 1 987 Repor twas au th or ed b yth e Hou s e Bu dg et Commit

tee orth e House En er gyan d Commer c eCommit t ee. See 561 F. 3d 2 33, 250 ( 2 0 09). As pet i tion er s ex plain , alth ou ghth e Bu dg et Commi tte e compiled and issued the Re port, the Ener gyand Comm er c eCommitte e wrote and ap proved there levant la nguage. Title IV of the Report, entitled “Co m mittee on Ene r gyand Com m er c e ,” c o mprises “ t wo Com

mittee Pr ints appr ov ed byt h e Commi ttee on Ener gyandCommer c efo r inclusion in the forthcoming reconcilia tion bill.” 19 87 Re port 377, 38 0.

10 The major i ty sug g e sts tha t the 19 87 legi s l ationc r e atin gth e fu n d

-12 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### 1987 had a number of options before it, including adopting an entirely different compensation scheme, as the Reaga n administration was proposing; 11 

### establishing different limitations on tort liability, including elimina t ing design defect liability, as pharmaceutical industry l e aders were advocating; 12 

### or not funding the co mpensationprogram at all, which would have effectively nullifi e d the relevant portions of the Act. Because the tort reform s in the 1986 Act, including §22(b)(1), had no operative legal eff e ct unless and until Congress provided funding for the com

pensation p r ogram, the views of the Congress that enacte d that funding legislation are a proper and, indeed, authori

tative guide to the m e aning of §2 2(b)(1). Th ose views, as reflected inthe 1987 Report, pro vide unequ ivocal confir

-

—————— ing mechanism is akin to appropriat ions legisla t ion a n d that giving weight to the l e gislative history of such legisla t ion “would set a danger

ous precedent.” Ante , at 18. The difference, of course, is that ap pro priations legislat ion ordina rily f unds congres s i ona lena c tments tha t already have operative legal effect; in co ntrast, operation of the tort r e for m s inth e 1986 Ac t, in c l u d in g§22(b)(1), was ex pr esslyc o n d ition e d on the enac tment of a separ a te t a xto fund the compensation program. S ee §32 3 ( a) , 10 0 S t at . 37 84

. Accordingly, t h is Court ’ s genera l reluc

tan c e to v i e wappr opr i ati o n s legi sl atio nas modify i n gsu bstan t iv e legisla t ion, see, e. g. , TV Av. Hill , 437 U. S. 153, 19 0 (197 8), h a s n o bear in gh e r e .

11 See 198 7 Rep o r t700 (desc r ibin gth e ad min i str a tion ’ s alter n ativ e proposal).

12 See, e. g. , Hearings on F unding of the Chi l dhood Vaccine Program before the Subcommittee o nSelect Revenue Measuresof the House Commi ttee onWay s an d M e an s, 100 thCon g ., 1st S e ss., 85 (1 987 ) (“[T]he liabili t yprovisions of the 1 986 Ac t sh ou ld be ame n ded to a ssu r e that manufact u rers will notbe found liable in the tort system if they have fully co mplied wi th a pplicable government regul a tions. In p a r t i cula r, m a nufa c t u rers s h ould notfa ce liab ilit yunder a‘des ign defect ’ theory in cases where plaintiffs challe nge the decisions of public health authorities an d federal regulators that the licensed vaccines are the best av ail able wayto pr otec t c h ildr e nfr omdeadlydise as es” (s tate men t of Robert B. Johnson, P r esident, Le derle Laboratories Division, Ameri

c a nCy an amid Co.)).13 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### mation of petitioners’ reading of §2 2(b)(1). In sum, the text, struct ure, and legi slative hist ory of the Vaccine Ac tare fully c o nsistent with petitioners’ reading of §22(b)(1)

. Accordingly, I bel i eve §22(b) (1) exempts vaccine manufacturers from tort liability only upon a showing by the manufa cturer in each case that the vaccine was properly manufactured and labeled, and t hat the side effects stemming from the vaccine’s design could not have been prevented by a fe asible alter native design that wo uld have eliminated the adverse side effects without compro

mising the vaccine’s co st and utility. II In contrast to the interpre tation of §22(b)(1) set fort h above, the majority’s i n terpretati on does considerable vio

lence to th e statutory text, misconstrues the legis l ative history, and draws the wrong co nclusions from the struc

ture of the Vaccine Act and the broader federal scheme regulating vaccines. A As a textu a l matter, the majority’s interp r e tation of §22(b)(1) is fundamentally flawe din three central re spects. Fir s t, the majority’s categ o rical reading rests on a faulty and untenable premise. S e cond, its r e ading func

tionally excises 13 words from the statutory text, includin g the key term “unavoidable.” And third, the majority en

tirely ignor e s the Vaccine Act’s default rule preserving state tort law. To begin, t h e majority states that “[a] side effect of a vaccine could always have been avoidable b yuse of a differently designed vaccine not containing the harmfu l element.” Ante , at 7. From that premise, the majority concludes that the statute must mean that “the designof the vaccine is a gi ven, not subject to question in the to rt action,” because construing the statute otherwise would14 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### render §22(b)(1) a nullity. Ibid

. A tortclai mant, accor d

ing to the majority, will a l ways be able to point to a diff er ently designed vaccin e not containing the “harmful ele

ment,” and if that were sufficient to show that a vaccine’s side effects were not “u navoi dable, ” the statute would pre

empt nothing. The startin gp r emise of the maj o rity’s inte rpretation, however, is fatally flawed. Although in the most literal sense, as t h e majority notes, a side effect ca n always be avoided “by use of a di fferently de signed vaccine not con

taining the harmful element,” ibid ., this interpretation of “unavoidable” would effectively read the term out of the statute, an d Congress could not h a ve intended that result. Indeed, §22 (b)(1) specifically uses the conditional phras e “if the injury or death resulted from side effects that wer e unavoidable,” which plainly indic a tes that Congress con

templated that there would be s o me instances in whicha vaccine’s side effects are “unavoidable” an d other in

stances in which they are not. See supra , at 3. The maj o r ity’s premise that a va ccine’s side effects can always be “avoid[ed] by use of a diffe rently designedvaccine n o t containing the harmful elem ent,” ante , at 7, entirely ig

nores the f a ct that re moving the “harmful element” will often result in a less effective (or entirely ineffective) vaccine. A vaccine, b yits nature, ordinarily employs a killed or weakened form of a bacteria or virus to stimulate antibody production; 13

### removing that bacteri a or virus might remove the “harmful element,” but it would also necessarily render the vaccine inert. As expl ained above, the legislative history of the Vaccine Act and the cases interpreting comment kma ke cl ear thata side effect is

——————

13 See American Academy of Pediatri cs, Questions and Answers about Vaccine Ingre d ients (Oct. 2008), http://www.aap.org/im m unization/ familie s/faq/V a ccineingredients.pdf (a ll Int e rnet material s as visite d Feb. 18, 201 1, an d av ailable i nCler k of Cour t’ s c a se file).15 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### “unavoidable” for pu rposes of §22(b )(1) only wh ere there i s no feasible alternative design that would eliminate t h e side effect of the vacc ine without compromising its cost and utility. See supra , at 7. The majority’s premise—that side effects stemming from a vacc ine’s design are always avoidable—is thus belied by the statutory te xt and legisla

tive history of §22(b)(1). And beca use its starting premise is invalid, its conclusion—that the design of a vaccine is not subject to challenge in a tort action—is also necessar

ily invalid. The majority’s readingsuffers from an even more fun

damental defect. If Congress intended to exempt vaccin e manufacturers categori cally from all design defect liabil

ity, it more logically would have provided: “No vaccin e manufacturer shall be liable in a civil action for damages arising from a vaccin e -related injury or death associated with the administration of a vaccine after October 1, 198 8, if the vaccine was properly prepared and was accompanied by proper directions and wa rnin gs.” There would have been no need for Congress to include the additional 13 words “the injury or death resulted from side effects tha t were unavoidable even though.” See TR W Inc. v. An

drews , 534 U. S. 19, 31 (2001) (n oting “cardi nal principle of statutory construction that a statute ought, upon the whole, to be so construed that, if it can be prevented, no clause, sentence, or word shall be superfluous, void, or insignificant” (internal quotation marks omit ted)). In Bate sv. Dow Ag rosc ience sLLC, 544 U. S. 431 (2005), this Court considered an analogous situation where an express pre - emption provision stated that certain Sta t es “ ‘shall not impose or continue in effect any requirement s for labeling or packagi n g in addition to or different from those required under this subchapter.’ ” Id. , at 436 (quot

ing 7 U. S. C. §136v(b) (2000 ed.)). The Bates Cour t stated:16 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### “Conspicuously absent from the submission s by [re

spondent] and the Uni t ed States i s any plausible al

ternative interpretatio nof ‘in addition to or different from’ that would give that ph rase meaning. Instead, they appea rto favorr e ading those words ou t of the statute, wh ich would l e ave the following: ‘Su c h State shall not impose or continue in effect any require

ments for labeling orpackaging.’ This a m putated version of [the statute ] would no doubt have clearly and succinctly commanded the pre-emption of all state requirements concerning la beling. Th at Con

gress added the remainder of the provision is e vidence of its intentto draw a distinction between state label

ing requirements that are pre-empted and th ose that are not.” 544 U. S., at 448–449. As with the statutoryinterpre tati on rejected by this Cou r t in Bates , t h e majority ’s interpret a tion of §22(b)(1) func

tionally excises 13 words out of th e statute, i n cluding th e key term “u navoidable.” See Duncanv. Wa lke r , 533 U. S. 167, 174 (2001) (“We are especially unwillin g” to treat a statutory te rm as surplusage “when the term occupies so pivotal a pl ace in the statutory s c heme”). Although the resulting “amputated version” of the statutory provision “would no doubt have clearly and succinctl y commanded the pre-emption of all state” desig ndefect claims, the fac t “[t]hat Con gress addedthe remai n der of the provision” is strong evid ence of its intent not t o pre-empt design defect claims categorically. Bates , 544 U. S., at 449; see als o Americ a n Home Prods. Corp. v. Ferr ari , 28 4 Ga. 384, 393, 668 S. E. 2d 236, 242 (2 008) (“ ‘If Congress had intended to deprive injured parties of a long available fo rm of compen

sation, it s u rely would have expressed that intent more clearly’ ” (q uoting Ba te s , 544 U. S., at 449)), cert. pendin g, No. 08–1120. Stri kingly, the majority concedes that its interpretation17 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### renders 13 words of th e statute entirely superfluous. See ante , at 12 (“The intervening pa ssage (‘the injury or death resulted from side ef fects that were unavoidable even though’) is unnecessary. True enough”). Ne vertheless, the majority co ntends that“the rule against givin ga portion of text an int e rpretation which ren d ers it superfluous .

. . applies onlyif verbosity and prolixity can be el iminated by giving the offending passage, or the remainder of the text, a competing interp reta tion.” Ibid

. Ac cording t o the major

ity, petitioners’ reading of §22(b)(1) renders the “ev e n though” cla u se superfluous beca use, to reac h petitioners ’ desired outcome, “[i]t would suffi ce to say ‘if the injury or death resulted from side effects that were unavoidable’— full stop.” Ibid. As explained above, however, the “even though” clause establis hes two additional prerequisites

— proper manufacturing and proper labeling—to qualify for §22(b)(1)’s exemption from liability. Contrary to the ma

jority’s cont ention, then, the “even though” c l ause serves an important function by limiting the scope of the pre

emption afforded by the preceding “if ” clause. 14 

### The majority’s only other textual argument is based on

——————

14 In this m a nner , the “ev e n though” c l au se fu n c tion s ina “ c on c e ssiv e subordinat[ing]” fashion, ante , at 11, inacc o r dwith n o rmal g r amma ti

c a l usag e. Ac c o r d ingto the major i ty , howev e r , the “ev e n though” c l ause “clarifies the word that precedes i t” by “ d elineat[ing] ” the c o nditions th at make a side effec t“u n av o idable” u n derth e statu t e. An t e , at 7. The major i ty ’ s inter p r e tatio nhar d ly tr eats the c l ause a s “c onc e ssiv e ,” and indeed strains the meaning of “e v e n though .” In the ma jor i ty ’ s v i ew, pr oper man u f ac tu r i ngan d labelin g are the sole prerequisites th at r e n d er a v a c c in e’ s side effec t s u n av o idable. Thu s , an in ju r i ou s side effect is unavoidable b ecauseth e v a cc i n e w a s p r o p erly prepared and labeled, not “e v e n though” itwas. Thetwo conj u n ctions a r e not eq uiva

lent: The s e ntence “I a mhappy even t h ou ghit is rainin g” can hardly be r e ad to me an that “ I a mha ppy b ecauseitis raining.” I nany event, the mor efundamental point is that peti tioners’ interpret a tion actually giv e s meaningto the wor d s “ev e n tho u gh ,” wher ea s the m a jor i t y concedes t h a tit s int e rpret a t i on effect ively rea d s t h os e words ent i rely out of the statute. See supra this page.18 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### the expres si o unius , exclusio alte ri uscanon. Accordin g t o the majority, because blackletter products liability l a w generally recognizes three different types of product d e fects, “[i]f all three were intend ed to be preserved, it would be strange [for Congress] to m e ntion specifically only two”—nam ely, manufacturing an d labeling defects in the “even though” clause—“and leave the third to implication.” Ante , at 8. The majority’s argu ment, however, ignores that the de fault rule u n der the V a ccine Ac t is that sta t e law is preserved. As explained above, §22( a) expressly provides that the “[g]eneral rule” is that “Sta te law shall apply to a civil action brou ght fordamages for a vaccine

related injury or death

. ” 42 U. S. C. §300aa–22(a). Be

cause §22( a) already preserves state-law design defect claims (to t h e extent the exempti o n in §22(b )(1) does n o t apply), there was no need for C o ngress separately and expressly to preserve design def e ct claims in §22(b)(1). Indeed, Congress’ principal aim in enacting §22(b)(1) was not to preserve manufacturing and labeling claims (those, too, were already preserved by §22(a)), but rather, to federalize comment k -type prote ction for “unavoidably unsafe” vaccines. The “even thou gh” clause simply func

tions to l i m i t the appli c ability of that defense. The lack of express lan guage in §22(b)(1) specifically preserving de

sign defect claims th us cannot fairly be u n derstood as impliedly ( and categorically) pre-empting suc htraditional state tort claims, whic h had already been p r eserved b y §22(a). 15

——————

15 This Court, moreover, has long ope r ated on “the assumption that the historic po lice powers of the Stat e s are not to be superseded by the Federal Act unless that w a s the cle a r an d manife st purpose of Con

g r ess. ” AltriaGroup, Inc

. v. Good , 555 U. S. ___, ___ (2008) (sli p op., a t 5) (inter nal quotation mar k s and alter a ti on omitted). Giv e n the long h i stor yof sta t e r e g u lationof v a c c i n e s, see Br ief forPetiti on er s 3–6, th e pr esu m ptionp r ov ides anad dition alr e aso nn o t to r e ad §22(b)( 1 ) a s pr e empting all de sign defect cla i ms, espe cia l ly givenCongre s s ’ inclus ion of19 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### The majority also suggests that i f Congress wished to preserve design defect claims, it could have simply pro

vided that manufacturers woul d be liable for “defective manufacture, defective directi ons or warnin g, and defec

tive design.” Ante , at 8 (internal quotation marks omit

ted). Putting aside th e fact that §22(a) alrea d y preserve s design defect claims ( t o the exten t§22(b)(1) does not ap

ply), the m a jority’s pro p osed solution would not have fully effectuated Congress’ intent. As the legislative history makes clear, Congress used the term “unavoidable” to effectuate its intent t hat the “p rinciple in CommentK regarding ‘unavoidably unsafe’ products .

. . apply to the vaccines covered in the bill.” 19 86 Report 26; see a l s o 1987 Report 691. At the time of the Vaccine Act’s enact

ment in 19 86, at lea s t one State had expressly rejected comment k , 16

### while many others had not addressed the applicability of comment kspecifically to vaccines or ap

plied comment kto civil actions proceeding on a theory other than strict liability ( e.g. , negligence 17

### ). A sta t ute

—————— anex pr ess s a v in gc l au se inth e sa me st atut ory s e ct i o n, s ee 42 U

. S

. C

. §300 aa–22( a), an d it s u s e o f th e c o n d itio n a l “if” c l au se indefin i n gth e pre-emptive scope of the pro v ision. See Bates v. Dow Agro scie n c es LLC, 544 U. S. 4 31, 44 9 (2 00 5) (“ I nar eas of tr a d ition a lst ate r e g u lation , we assu me th a ta feder a l stat u t e h a s n o t s u pplan ted sta t e lawu n l es s Congres s ha s ma de s u ch a nintention clea r a n d ma nifes t” (interna l quotation marks omitted)).

16 See Collins v. Eli Lilly Co. , 116 Wis. 2d 1 66, 1 97, 342 N. W. 2d 37, 52 (1 984) ( “W ec o n c lu de that th e r u le embodied inc o mmen tk is t oo restrictive and, therefore, not co mmensur ate with str i c tpr oduc ts liab ility l a w i nWisconsin”). Collins did, however, “re c ognize that i n some ex ig ent c i r c u mstanc es it m a ybe nec e ssar yto pl ac e a dr ugon the mar k et befor eadequate te st ingc a n be done.” Ibid

. It thus a d opted a na rrowe r defens e (b as ed on“ e xigentcirc um s t a n ces ” ) tha nt h a trecog nized in other j u ris d ictions tha thad expre ssly adopte d comment k

.

17 See, e. g . , Kea r l , 172 Cal. App. 3d, at 831 , n . 15, 218 Cal. Rptr ., at 465, n

. 15 (“[T]h e un av oidablydan g er ou s pr odu c tdoc t r i n emer e l y exempts the product from a strict liabil i t ydesig ndef e c tan aly s i s ; a pla i ntiff remains free to pur s ue his de sign defect theory on the basis of20 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### that simply stated tha tvaccine manufacturers would be liable for “defective design” woul d be silent as to the a v ail

ability of a comment k -type de fense for “unavoidably unsafe” vaccines, and t hus would not have fu lly achieved Congress’ aim of extending gre a ter liability p r otecti on to vaccine manufacturers by pro viding com m ent k -type protection in all civil actions as a matter of federal law. B The majorit y ’s st ructu r a l arguments fare no b e tter than its textual ones. The principal thrust of the majority’s position is that, since nothing in the Vaccine Act or the FDA’ s regu lations governing vac c i nes expressly mentions design defects, Congre ss must have intended to remove issues concerning the design of FDA-licensed vaccines from the to rt sys t em. Ante , a t13. The flaw in that rea

soning, of course, is that the FDA’s silence on design de

fects existed long before th e Va ccine Ac t was enacte d. Indeed, the majority i t self concedes that th e “FDA ha s never even spelled out in regulations the criteria it uses t o decide whe t her a va cc ine is safe and effectiv e for its in

tended use.” 18 

### Ibid. And yet it is undisputed that prior to the Act, va ccine manufacturers h a d long been subject to liability under state to rt law for defective vaccine design. That the V a ccine Act did not itself set forth a comprehen

sive regulatory schem e with resp ect to design defects is thus best u n derstood to mean not that Congress suddenly decided to change course sub silentioand pre-empt a

—————— negligence”); Toner , 112 Idah o, at 340, 732 P. 2d, at309 –31 0 (“T h e authorities universally agree that where a product is deemed unavoid

ablyu n s afe, t h e plain t iff is depr iv ed of th e adv a n t ag e of a str i c tli abi l

ity cause of action, but may proceedund er a negligence cause of ac tion”).

18 See 42 U. S. C. §262(a)( 2 )( C)(i)(I) (“Th e Sec r e tar ysh all appr ov e a biologics license applica t ion

. . . on th e basis of a demon s t r ationth at .
. . the biological product thati s the subj ec t o f the applic a t i o n is safe, pur e , and potent”).21 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### longstanding, traditional cate goryof state tort law, but rather, tha tCongress intended to leave the status quo alone (except, of cours e , with res p ect to those aspects of state tort l a w that th e Act expre ssly altered). See 1987 Report 691 (“It is notthe Comm ittee’s intention to pr e clude court actions under applica b le law. The Commit

tee’s intent at the time of considering the Ac t .
. . was . . . to leave otherwise applicable la w unaffected, except a s expressly altered by the Act”). The majority also suggests that Congress necessarily intended to pre-empt design defect claims since the aim of such tort suits is to promote the developmentof improve d designs and provide co mpensationfor injured individuals, and the Va ccine Ac t “ p rovide s other means for achievin g both effects”—most notably through the no-fault compen

sation prog ram and th e National Vaccine P r ogram. Ante , at 14, and nn. 57–60 (citing 42 U. S. C. §§300aa–1, 300aa– 2(a)(1)–(3), 300aa–3, 300aa–25(b), 300aa–2 7(a)(1)). But the majority’s position elides a significant difference be

tween state tort law a n d the federal regulat o ry scheme. Although t h e Vaccine Act cha r ges the Secret a ry of Heal th and Huma n Services with the obligation to “promote the development of childhood vaccines” and “make or assure improvements in . . . vaccines, a n d researchon vac c ines,” §300aa–27( a), neither the Act nor any other provision of federal law places a legal dutyon vaccine m anufacturers to improve the design of their vaccines to account f o r scientific a n d technological advances. Indeed, the FDA does not condition approval of a vaccine on it being the most optimally designed among reasonably available alternatives, nor does it (or any other federal entity) en

sure that li censed vacc ines keep p a ce withte chnological and scientific advances. 19 

### Rather, the function of ensuring

——————

19 See, e. g. , H u rleyv. L e de rle Lab s . , 863 F. 2d 11 73, 1 1 7 7 (CA5 1 9 8 8) (“[T]he FDA is a passive agency: it co nsiders whether to appro v e22 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### that va ccin e s are optimally desi gned in light of existing science and technology has tra ditionally beenleft to the States th rough the im position of damages for design de

fects. Cf. Bat e s , 544 U. S., at 451 (“ ‘[T]he spec ter of dam

age actions may provide manufa cturers with added dy

namic incentives to continue to k eep abreastof al l poss ib le injuries ste m ming from use of their product[s] so as to forestall such actions through product im provement’ ”); Wyeth v. Levine , 555 U. S. ___, ___ (2009) (slip op., at 22–

—————— va ccine des i gn s only if a n d when m a nufa c t u rers com eforwa r d wit ha proposal”); Jones v. L e de rle Lab s . , 695 F. Su pp. 700, 7 1 1 (EDNY 198 8) (“[T]he agency takes th e drugs a n d manufa c ture rs a s it finds them. While it s goal is to oversee i n oculation with the bes tpos s ible vaccine, it is lim ited to reviewing o n ly those dr u g s submit ted byv a r i ou s man u f ac t u rers , re ga rdles s of t h eir fla w s ” ). Alt h ough t h e FDA ha s a u t h ority underex istingr e gulations to r e v o kea man u f ac tu r e r’ s biologic s lic en ses, that authority can be exercised onlywhere (as relevan there) “[t]he licensed product is not safe a n d effectiv e for all of i t s inte nded uses.” 21 CFR §6 01.5(b) (1)(v i) (201 0); see §60 0 .3(p) ( d efin in g“safet y” as “r elativ e freedomfrom ha rm ful effectt opers ons a ffect ed, direct l yorindirect ly , bya pr odu c t wh enpr u d en tlyadmin i ster ed, taking into consideratio n the c h ar ac ter of the pr oduc t in r e lati on to the condition of the re cipient at the time ”). The r e g u lation does not author ize the F D A to r e v o ke a biologics license for a manufacture r ’ s failur eto adopt an optima l va ccine des i gnin light of exi s ting s c ience a n d technology . S ee Conk, Is There a Design Defe ct in th e Restat e m e n t (Third) of Torts: Products Liabi lity ? 10 9 Y a le L. J. 108 7, 112 8– 11 29 (199 9–2 00 0) (“ Th e FDA does not c l aim to rev i ew pr od uc t s foroptimal desig n. . . . FDA r e v i ew thu s asks les s of dr ug. . . manufac tur e r s than the c o mmon l a w of pr oduc ts liab ility a s ks of other kind s of ma nufact u rers”). At oral argument, couns el for am i c u s United States stated thatthe Centers for Disease Control and P r evention (CDC) routin ely performs comparative analyses of v a c c i n e s th at ar e alr e adyonth e mar k et. See Tr . of Or al Ar g . 44– 45; id. , at 52–5 3 (desc r ibin gCDC’ s c o mpar isonof Sabinan d Salk poli o va ccines )

. Ne it her t h e Unit ed S t at es nor a n y of t h e pa rt ies , however, has represented that CDC examin es whet her as a fer a l t e rna t iv e va ccine could have b e en des i gne d given p r actical and s c ientific limits , t h e cent ra l inq u iry in as t at e t o rtla w a c t i on for des i gn defect

. CDC does not i ssue biologics licen ses, mor eover, and thus has no authority to r e qu ir e a man u f ac tu r e r to adopt a differ e n tv a c c i n edesign

.23 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### 23) (noting that the FDA has “trad i tionally regarded stat e law as a complementary form of drug re gulation” a s “[s]tate tort suits uncover unkno wn dru gh a zards and provide incentives fordrug manufacturers to disclos e safety risks promptly”). 20

### The importance of the States’ traditional regulatoryrole is only unders c ored by t h e unique features of the vaccine ma rket, inwhi c h there a r e “only one or t w o manu facturers fo r a majorit yof the vac cines listed on the routine ch ildhood immuniz a tion sched

ule.” Brief for Respondent 55. The normal competitive forces that spur innovation and i m provements to existi ng product lines in other mark ets thus operate with less fo rce in the vaccine market, particularlyfor vaccines that have already been released and marketed to the public. Absent a clear statutory man d ate to the contrary, there is no reason to t h ink that Congress intended in the vaccine context to eliminate t h e traditional incentive and det e r rence functions servedby state tort liability i nfavor of a federal regulatory scheme pr oviding only carrots and no sticks. 21 

### See Levine , 555 U. S., at ___ (slip op., at18) (“The

——————

20 Indeed, we observed in Levine that the F D A is perpetually under

staffed and underfunded , see 555 U. S ., at ___, n. 11 (slip op., at 2 2 , n . 11), an d th e ag en c yh a s beenc r i ti cized in t h e pa st for it s s l ow re sponse in f a il ing to withdraw orwa rn ab o ut potentia lly da ngerous products, see, e.g . , L

. L e v e t o n , H

. S o x , & M

. S o t o , I n s t i t u t eo f M e d i c i n e , HIV and the Blood Supp l y : An Anal ysis of Cris is Decisionmaki ng (1 9 9 5 ) (crit i cizing FDA res p ons et o transmi ssion of AIDS through blood supply). The s e practical shortcomin g s rein for c eth e con c lu sionth a t “st a te l a w offer s anaddi ti on al, an d im por t an t, lay e rof c o n s u m er pr otec tion tha tc o mplement s FDA r e g u lati on.” Levine , 555 U. S., at

__ _ (s lip op., at 23).

21 The major i tymisc har a c t er izes my posit i o nas ex pr essin ga g e n e r a l “skeptic[i sm] of preemption unless th e congressional substitute oper

ate[s] like the tort system.” Ante , a t1 6

. Congres s could, of cours e , adopt a r e g u lator yr e gi me that oper ates differently from state tort sy stem s, an d su c ha differ e n c e is n o t n e c e ssar ily a r e a s onto qu estio n Congress’ pre- emptive intent

. In the specific context of the Vaccine Act, howev e r , the relev a nt point i s that thi s Co ur t should notlightly assum e24 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### case for federal pre-emption is particularlyweak whe r e Congress has indicated its aware n ess of the operation of state law in a field of federal interest, and has nonetheles s decided to stand by both concep ts and to tolerate whatev er tension there is between them.” (i nternal quotation marks and alteration omitted)). III In enacting the Va cc ine Act, C o ngress established a carefully wrought fede ral scheme that balan ces the com

peting interests of vaccine-injured persons and vaccin e manufacturers. As the legislativ e history indicates, the Act add r essed “two overriding c o ncerns”: “(a) the inade

quacy—fro m both the perspective of vaccin e -injured per

sons as well as vacci ne manufacturers—of the current approach to compensating those who have be en damaged by a vaccine; and (b) the instabili ty and unpredictability of the childhood vaccine market.” 1986 Report 7. When viewed in the context of the Vaccine Act as a whole, §22(b)(1) is just one part of a broader statutory schem e that balances the need for compensating vaccine-injure d children wi th added liability protections for va ccine manu

facturers to ensure a st able childhood vaccine market. The princip a l innovation of the Act was the creation of the no-fault compensation program—a scheme fund ed entirely thr o ugh an exc i se tax on v a ccines. 22 

### Th rough that

—————— that Cong r e ss intended sub silentio to displac ea lon g st an din gspec ies of state tort li abil i ty where, as he re, Congress specifica lly included a n ex pr ess sav i n gc l au se pr eserv i n gst ate l a w, there is a long history o f state-law regulation of vaccine de sign, a n d pre-emption of state law would leave a nimportan t r e g u lator yfunc tion— i.e. , ensuring optimal v a c c i n edesig n—en tir e lyu n a ddr essed byth e c o ng r e ssion al su bsti tu te.

22 The major i ty ’ s sug g e stion t h at “v ac c i ne manufac tur e rs fund fr om their sale s” the compensationprogram is mi slead i ng. Ante , at 15

. Althoughthe manufac tur e rs nominallyp a y the tax, the amount of the tax is specifically included in the vaccine price charge d to purchasers. See CDC Vaccine P r ice List (F eb. 15, 2011), http ://www.cdc.gov/25 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### program, Congress relieved vaccin e manufacturers of the burden of compensating victims of vaccine-related injuries in the vastmajority o f cases 23

### —an extremely significant economic benefit that “functi onally creat[es ] a valuabl e insurance policy for vaccine-relat ed injuries.” Reply Brief for Petitioners 10. Th e structu re and legislative history , moreover, point clearly to Co ngress’ intention to diver t would-be tort claimant s into the compensation program , rather than elim inate a longstanding category of tradi

tional tort claims. See 1986 Rep o rt 13 (“Th e Committee anticipates that the speed of the compensation program, the low t r a n saction costs of the s y stem, the no-fault na

ture of the required f i ndings, and the relat i ve certaint y and generosity of the s y stem’s awards will di vert a signifi

cant numb e r of potential plaintiffs from litigation”). In

deed, although comple te pre-emption of tort claims would have eliminated the p r incipal source of the “u npredictabi l

ity” in the vaccine market, Congress specific ally chose no t to pre-emptstate tort c l aims categorically. See 42 U. S. C

. §300aa–22( a) (providing as a “[g]eneral rule” that “State law shall apply to aci vil action b r ought for damages for a vaccine-related injury or death” ). That decision reflects Congress’ recognition that cour t actions are essential

—————— va ccines /pro g r a m s /vfc/cdc- v a c -price-lis t
. ht m . Accordin gly, t h e onl yway the v a c c i ne m a nufac tur e r s can be said to a c tually“fund” the c o mpensa tion program is if the cost of the excise tax has an imp a ct on the num

b e r of va c c ine s s o ld b yt h e va ccine m a nuf a c t u rer. The m a j o rit ypoints to no evidence that the excise ta x—which ordina rily a m ounts to 7 5 c e n t s perdose , 26 U. S. C. §413 1(b)—h as an yimpac twh atsoev eront h e dem a nd for va ccines

.

23 See Brief for United St ate s as Am icus Cu riae28 (“Depar tmen tof J u s t ice record s indica t et h at9 9

. 8 % of s u cces s f ul Com p ens a t i on Pro

gra mcla i m a n t s have a ccepted t h eir a w a r ds , foregoing a n y t o rtrem e dies a g a i nst va ccine ma nuf a c turers ”); S

. Plotkin, W. Orens t ein, & P. Offit, Vac c i n e s 1 673 (5th ed. 200 8) (n otin gth at “[v] ir tu allyall

. . . petitioners, even those who were not awarded c o mpensa tion” underthe compensation program, choo se to a cceptt h e progra m ’ s de t e rm ina t ion).26 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### because they provide injured p e rsons with significant procedural tools—inclu d ing, most importantly, civil dis

covery—tha t are not a v ailable in administrative proceed

ings under the compensation program. See §§300aa– 12(d)(2)(E), (d)(3). Congress thus clearly believed there was still an important function to be played by state tort law. Instead of eliminating design defect liability entirely, Congress enacted num erous meas ures to reduce manufac

turers’ liability exposure, including a limitedregulatory compliance presumption of adequate warnings, see §300aa–22(b)(2), elimination of c l aims bas ed on failur e to provide direct warnings to patients, §300aa–22(c), a heightened standard for puni tive dama ges, §300aa– 23(d)(2), and, of course, immunity from damages for “un

avoidable” side effects, §300aa–2 2(b)(1). Considered in light of the Vaccine Act as a whole, §22(b)(1)’s exemption from liability for una voidably unsafe vaccines is just one part of a broader statutory schem e that reflects Congres s ’ careful bala n ce between providing adequate c o mpensation for vaccine-injured children and conferring substantial benefits on vaccine manufacturers to ensure a stable and predictable childhood vaccine supply. The majority’s decision today d i sturbs that carefu l balance bas ed on abare policy preference that it is b e tter “to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.” An t e , a t15. 24 

### To be sure, reasonable minds can disagree about the wisdom of having juri es weigh the relative cost s and benefits of a particular vac

cine design. But wha t ever the merits of the majority’s

——————

24J US TI CE B RE YER ’s se parat econcurre nceis even mor eexplicitly policy driven, reflecting his own pref erence for the “mor eexpert judg

ment” of fede ral agencies over the “less expert” judg ment of juries. Ante , at 5.27 Cite as: 56 2 U

. S. ____ (2011)

S OTOMAYOR , J., dissen t in g 

### policy preference, the decisionto bar all design defect claims against vaccine manufacturers is one t hat Congre ss must make , not this Court. 25

### B y construing §22(b)(1) to

——————

25 Respondent notes that there are so me 5, 000 peti tions allegi nga c a u s al lin k betweenc e r t ainv a cc in es and au tism spec tr u mdisor d er s that are currently pending in an omnibus proceeding in the Court of Feder a l Clai m s (Vac c i n eCou r t). Br ief for Respon den t56–5 7. Ac c o r d

ing to respondent, a ruling that § 22(b)( 1 ) does not pr e-empt de sign defectcla i ms could unlea s ha “ crus h ing wave” of t o rt lit iga t ion t h at would b a n kru p t va ccine ma nufa c turers and deplete vaccine supply. Id. , at 28. Th is c o n c er n un der lies manyof the polic y ar g u ments i n res p ondent’s b r ief a n d a ppears to underlie the ma j o rity and conc ur ring opinions in th is case. In th e ab se nce of any empirica l data, however, the prospect of an onslau gh t of autism-r el ated tor tli tig a tion byc l aim

a n t s denied relief b yt h e Va ccine Co urt s eems wholly speculative. As an initi a l mat t er, the specia l ma sters in the a u tis m ca ses have thus far uniform ly rej e ct ed t h e a lleged ca us a llin k betweenv a cc ines an d au tism. See Brief for American Academ y of Pedi atrics et al. as Amici Curiae 2 0

– 2 1 , n. 4(co llect ing ca s e s )

. To b es u re, t h os e rulings d onotneces s a r ilymean that no suc h causal link exists, cf. Brief for United State s a s Am icus Cu riae 29 (noting that injuries h ave been adde d to the Vaccine Injur yTable f o rex istingv a c c i nes), orthat c l aimant s willnot ultim a tel y be able to pr o v e su c ha lin k ina state tor tac tion , par t i c u l ar lywithth e added tool of civil discovery. Bu t these ruling s do high light the s u b

s t a n t i a lhurdles t orecovery acla i m a ntfa ces . S ee Schaf e rv. Am e r ica n Cyanamid Co. , 20 F. 3d 1, 5 (CA1 19 94) (“[A] peti tion e rto wh om th e Vac c i ne Cour t giv e s nothingmaysee no po i n t in tr y i ngto ov er c o me tor t law’ s y e t mor eser i ous obst ac les to r e c o ver y”). Tr ial cour ts, mor eover , have considerable experience in e fficiently handling and disposing of mer i tles s pr oduc ts liabili tyc l aims, and decades of tor tlit igation (i n cluding for de s i gn defect) in t h e pres cript ion-dru gcont e x thave notle d to shortages i nprescription drugs. Despite the doomsd ay predictions of respondent and the various amicicit e d b yt h e conc ur ren c e, ante , at 6– 7, the possi bili tyof a tor r e nt of mer i tles s la wsuits b a nkr u ptingmanufac

t u rers a n d ca us ing va c c ines h ort a ges s e em s rem o t eatb e s t
. More fundamentally , whatever the merits of these policy arguments, the issue in this case is what Co ngress has decided, and as to that question, the text, structure, and legi slative history compel the conclusion that Cong r e ss intended to leav e the c o ur thouse doors open f o r childre n who have s u ffered s e vere inj u rie s fromdefect ively des i gned va ccines

. T h e m a j o rit y ’s policy-drive n de cis i on t ot h e co nt ra ry us urpsCongres s ’ rol e a n d deprives s u ch va ccine-i nj ured childre n of akey rem e dy t h a tCon

g r ess intended them to hav e .28 BRUE S EWIT Z v. WYETH LLC S OTOMAYOR , J., dissen t in g 

### pre-empt all design defect claims against va ccine manu

facturers f o r covered vaccines, the majority’s decision leaves a regulatory va cuum in which no one—neither the FDA nor any other federal agency, nor state and federa l juries—ensures that vaccine ma nufacturers adequately take accoun t of scientific and technological advancements. This concern is especially acute with respec t to vaccin e s that have already been relea s ed and marketed to the public. Manufacturers , given the lack of robust competi

tion in the vaccine market, will often have little or n o incentive to improve the designs of vaccines that are al

ready generating signi f icant profi tmargins. Nothing i n the text, str u cture, orlegislative history remo tely suggest s that Congre ss intended that result. I respectfully dissent.