Bruesewitz v. Wyeth LLC

WYETH LLC, BRUESEWITZ et fka WYETH, al. v. INC., et al. Argued 12, 2010 09-152. October February 22, No. Decided C. Frederick David the cause argued for petitioners. Ho, T. Derek Brendan J. Crim- were him the briefs With Collyn Williams, and mins, John Eddie A. Peddie. M.

Kathleen Sullivan argued the cause for respondent. Gay, were Faith E. I. Weis- her on the With brief Sanford burst, Adams, B. Daniel Thomasch, William J. Richard W Mark, Rosenkranz, E. Joshua Elliot, Lauren J. and John L. Ewald.

Benjamin J. Horwich cause argued the for the United curiae States as amicus affirmance. With urging him Acting Katyal, Solicitor General Assistant were brief Attorney Deputy West, General Solicitor Kneedler, General * M. Solet, S. Irene David Raab, Michael Benor. and of amici curiae urging

*Briefs reversal were filed for the American Nannery by for et Valerie M. and Leslie Brueck- al. Association Justice J., ner; by Vaccine Center Robert for the National Information et al. Holland; Mary Krakow S. Injured and for the Vaccine Petitioners Bar Maglio Anne Gore H. Meyers; et al. by and Peter Association for Jennifer Geistfeld, pro se; Mr. by A. for Mark and Kenneth Geistfeld W. Starr et al. Massey. by Jonathan S. Briefs of amici curiae urging were filed affirmance American Lawton; F. by and Stephan Lorane Hebert E. Academy of et al. Pediatries by David for the Chamber of Commerce of States of America United Gossett, Conrad, Sarwal; and Amar M. Robin S. D. for GlaxoSmithKline of the Court. delivered opinion Scalia Justice enacted provision consider whether pre-emption We Act of 1986 Injury the National Childhood Vaccine (NCVIA)1 vac- against bars state-law claims design-defeet cine manufacturers.

I A the last 66 vaccines have been to the years, subject For federal premarket approval process same as prescription for vaccine-related has injuries compensation drugs, left to the States.2 Under regime, been largely vaccination elimination communicable diseases through “one achievements” health became greatest public 198Q’s 20th in the But the 1970’s and vaccines century.3 one victims became, say, of their own success. might They infectious so effective diseases that preventing had been threat much less alarmed of those became the public risk diseases,4 and much more concerned of injury themselves.5 the vaccines Clement, Daryl Joseffer, Sangiamo, D. Dino S. David Paul by et al. LLC Owens, Bradley Wolff; S. Washington M. Diane Legal Gray, S. Andrews; Popeo Cory J. L. and for Patricia A. Daniel Foundation S. al. Martin et Buffter Kaufman. Lipton filed amicus curiae. Marguerite brief for Willner as M. Ann 300aa-22(b)(1). U. S. C. 1 42 Merrill, Grossman, 912-913, Hutt, Drug & L. Food Law R. P. (3d 2007). ed. 1458 3 Control, Health, in Public Achievements 1900- for Disease Centers Universally Children, Recommended for 48 Mor Impact of Vaccines 1999: Mortality Weekly Report 243, (Apr. 2, 1999). 247 bidity and 4 Against Disease, Infectious 200 Mortimer, Immunization Science See (1978). 902, 906 5 Advisory Committee, A Comprehensive Review Vaccine National See Safety Programs Public Activities 2-3 and Health Vaccine of Federal NVAC), 2008) (hereinafter (Dec. http://www.hhs.gov/nvpo/nvac/documents/ (as 2011, 18, visited available in vaceine-safety-review.pdf Feb. and Clerk file). case of Court’s

227 against the concern centered around Much of vaccines (DTP), pertussis diphtheria, tetanus, and which were blamed developmental delays. and disabilities children’s for This litigation. increase to a massive vaccine-related tort led only products-liability 1978 and 1981 between nine Whereas against DTP were filed manufacturers, suits mid- year.6 suits numbered more than 200 each 1980’s This causing DTP vaccine market, destabilized two domestic manufacturers withdraw; and the three remain- ing manufacturer, Laboratories, Lederle estimated its potential exceeded its tort annual sales a factor of shortages production arose Vaccine when Lederle had 200.7 problems in 1984.8 large

Despite many number of suits, there were com- obtaining compensation legitimate plaints that for vaccine- injuries costly significant and inflicted was too difficult.9 A parents already declining number of were vaccination for compensation children,10 concerns about their threatened depress even vaccination rates further.11 This was a public of concern to health officials, source since vaccines are preventing only large effective outbreaks disease if population percentage vaccinated.12 6 Sing Willian, Supplying See & Vaccines: An Overview of the Market Regulatory Context, in An Supplying Analysis Vaccines: Economic C, (M. Pauly, Robinson, & M. Sepe, Sing, Issues 51-52 S. M. Critical 1996). eds. Willian 7 id., See 52. 8 Control, Diphtheria-Tetanus-Pertussis See Centers Disease Vaccine (Dec. Morbidity Mortality Weekly Shortage, Report 33 695-696 1984). Detta, Liability Apolinsky Rethinking See & Van Injury, Vaecine Pol’y 537, 550-551 (2010); Burke, Lawyers, Cornell J. L. & Pub. T. Law suits, Legal Rights: Litigation Over Society Battle American (2002). 10Mortimer, supra, at 906. Schemes, Hagan, Compensation Drug See Vaccine Food Cosm. L. J. (1990). 477, 479 (5th Merrill, 2010). Epidemiology R. Introduction to 65-68 ed.

228 compensa facilitate market and

To stabilize the vaccine Act estab enacted the 1986. The tion, NCVIA “designed compensation program to work a no-fault lishes system.” greater ease tort than the civil faster (1995). person 268, 269 A Whitecotton, v. 514 U. S. Shalala legal petition guardian, may injured a a file vaccine, or his compensation Court of Federal in the United States Secretary naming and Human the of Health Services Claims, respondent.13 special infor A master then makes an as (except adjudication petition lim within two mal days.14 exceptions) 240 Court Federal Claims ited objections special review master’s decision and must similarly statutory tight judgment final under deadl enter options: accept point, has two At that a claimant ine.15 forgo judgment tort suit for court’s traditional damages, reject judgment tort and seek relief from manufacturer.16 adjudication possible is made Act’s informal

Fast, Injury Table, lists the vaccines which covered under Vaccine compensable, each vaccine’s side describes adverse Act; after how soon vaccination those side indicates effects; and first manifest themselves.17 Claimants who effects should injury appro- first itself at the listed manifested show compensation.18 prima entitled to priate are facie No time necessary; Secretary showing bears the causation is may disproving A also re- causation.19 claimant burden of еffects, side side and for listed effects that for unlisted cover specified Table, other than those but times occur 13 1(a)(1). §300aa-1 S. C. See 42 U. 14 300aa-12(d)(3). § See 300aa-12(e), (g). § See 300aa-21(a). § See (2009) (current §100.3 300aa-14(a); Injury 42 CFR Vaccine See Table). 300aa-13(a)(1)(A). 300aa-11(c)(1), §§C. 42 U. S. See 300aa-13(a)(1)(B). prove must the claimant causation.20 for those Unlike in required the Act not suits, claimants under are tort show defectively was vaccine the administered manufactured, designed. or labeled, compensation receive claimants for medical,

Successful re- special counseling, education, habilitation, and vocational earning capacity; training pain expenses; diminished and suf- fering; Attorney’s $250,000 for vaccine-related deaths.21 provided, only for are not successful cases, fees but even for claims unsuccessful that are frivolous.22 These awards by paid of a fund are out created an excise tax on vac- each cine dose.23 pro quo quid designed

The this, for to stabilize the vaccine provision significant protec tort-liability was market, requires Act tions for vaccine manufacturers. The claim through compensation program to seek relief ants before filing gener $1,000.24 for more than suit Manufacturers are liability ally they immunized from for failure warn if have regulatory complied requirements all (including with but not warning requirements) given limited and have the warn ing physician.25 either to claimant or the claimant’s They liability punitive damages are immunized from ab comply regulatory requirements, sent failure “fraud,” wrongful withholding “intentional and information,” or activity.”26 illegal “criminal or other And most relevant to 20 300aa-11(e)(1)(C)(ii). § See §300aa-15(a). See 300aa-15(e). § See 300aa-15(i)(2); §§4131, § C. See 26 U. S. 9510. §300aa-11(a)(2). C. See 42 U. S. (c). 300aa-22(b)(2), immunity not apply plaintiff See does if the convincing dear and evidence establishes manufacturer was fraud, guilty of negligent, wrongful or was intentional and withholding of information, activity. §§300aa-22(b)(2), or other unlawful 300aa- 23(d)(2). 26 300aa-23(d)(2). expressly present eliminates case, the Act unavoidable, adverse side effects:

vaccine’s in a ac- vaccine shall liable civil “No manufacturer arising injury damages tion for vaccine-related administration of vaccine death associated with the injury if or death 1, 1988, after October resulted though that were unavoidable even from side effects prepared accompanied properly was was warnings.”27 proper directions and

B here is a DTP vaccine manufactured vaccine at issue The approval It received federal Lederle Laboratories. first supplemental approvals and in 1953 1948 and received Wyeth purchased Respondent Lederle in 1994 and 1970. manufacturing stopped the vaccine in 1998. 20, was born on October 1991. Her Bruesewitz

Hannah pediatrician of the DTP vaccine administered doses accord- ing Center Disease Control’s recommended child- to the April 24 her schedule. Within hours of immunization hood experience started to vaccination, Hannah seizures.28 1992 during 100 seizures the next and month, over suffered She eventually diagnosed her with “residual seizure doctors her delay.”29 “developmental Hannah, a now disorder” teenager, diagnosed both conditions. still with parents, April Hannah’s Russell and 1995, Robalee In petition injury a vaccine filed United Bruesewitz, alleging that Hannah Claims, Federal suf- Court States encepha- residual seizure disorder and on-Table fered lopathy Special injuries.30 A denied their Master claims though they were awarded in at- grounds, $126,800 various 27 300aa-22(b)(1). 28 Secretary Servs., Dept. Health and Human v. See Bruesewitz (Ct. 2002). 31965744, Cl., 20, *3 Dec. 95-0266V, 2002 WL No. (CA3 2009). 233, 236 F. 3d supra, Bruesewitz, *1. torney’s reject fees costs. Bruesewitzes elected judgment, and in October 2005 unfavorable filed this law- Pennsylvania complaint alleged Their state court. suit here) (as that defective relevant Lederle’s DTP disabilities, caused Hannah’s and that Lederle vaccine was liability, subject negligent design, strict Pennsylvania common law.31 under

Wyeth the suit to the removed United States District Pennsylvania, District of for the Eastern Court which Wyeth summary judgment granted strict-liability on the negligence holding design-defect Pennsylva claims, that the providing pre-empted by those action law causes of was nia 300aa-22(b)(1).32 The United 42 U.S.C. States Court of Appeals granted for the Third affirmed.33 Circuit We cer (2010). tiorari. U. S.

II A statutory again We text set forth at issue: shall be “No vaccine manufacturer liable in civil ac- damages arising injury tion for from vaccine-related death the administration of associated injury if after or death October resulted though from side effects were unavoidable even properly prepared accompanied by vaccine and was was proper warnings.”34 directions and though” precedes

The “even clause clarifies word that preventative It it. measures that a delineates vaccine have taken ‍​​​‌​​‌‌​‌‌​‌​​​​‌​​‌​​​‌​‌‌​​‌​​‌‌‌​​​‌‌‌​​‌​​​‍a side effect to manufacturer for be consid- must ered “unavoidable” under the statute. Provided there

31 also 3d, complaint See F. 237. The upon 561 at made claims based longer to warn and defective manufacture. These are no at failure issue. 32 id., See at 237-238. 33 Id., at 235. 300aa-22(b)(1). 42 U. S. C. warning, any remaining proper side was manufacture including resulting design are effects, defects, those design-defect to have deemed been unavoidable. State-law pre-empted. claims are therefore

If a be to manufacturer could held for failure use liable design, do no work. different the word “unavoidable” would always A have side effect of a vaccine could been avoidable differently designed containing use of a not language sug- provision harmful element. The thus gests design given, subject to that the of the vaccine is question in the tort What statute action. establishes as complete (given unavoidability defense must be safe manu- respect design. warning) particular facture to implies open plainly design that the itself is not to Which question.35 A textual to the further indication leads same conclusion. Produets-liability law a classic well establishes known grounds liability: manufacture, triumvirate defective inadequate warnings, design.36 directions or and defective preserved, were to it If all intended would be three strange specifiсally only two, mention leave the to third (and implication. It have would been much easier much natural) provide that manufacturers would be liable more possibility: effect “[A] advocates another side is ‘un The dissent design is no feasible alternative . where there that would . . avoidable’ compromising effect of the vaccine without its cost and side eliminate the J.). Post, Sotomayor, (opinion The dissent makes utility.” at no 300aa-22(b)(1). position text We doubt to ground effort amorphous by implication an introduce such test would infra, micromanages vaccine manufacturers. it when otherwise expensive more an design idea how much alternative no We have 238. efficacy “compromisfesj” a vaccine’s cost how much can be before improve safety. can sacrifice Neither does dis alternative dismiss, who judges will the must rule on motions sent. And neither summary judgment, judgment and motions for as a matter of motions for probably test would have real-world that the no effect. means law. Which Keeton, Owen, & Dobbs, R. D. and Keeton Keeton, Prosser D. W. (Third) (1999). (5th 1984); §2 Restatement Torts ed. Law Torts manufacture, for “defective defective directions warning, or design.” defective It seems that the statute fails to design-defeet liability “by mention deliberate choice, not in- Peabody Barnhart v. Co., advertence.” Coal 537 U. S. 149, (2003). Expressio unius, eadusio alterius.

B principal argument The dissent’s textual is mistaken. We premise agree its that “‘side effects that were unavoid by able’ must refer to side effects caused a vaccine’s de sign.” comprehend, do not We step however, the second reasoning, its which is that the use of the conditional term introductory phrase injury “if” “if the or death re from side “plainly sulted effects that were unavoidable” im plies stemming that some side effects from a design vaccine’s ”38 while ‘unavoidable,’ are others are avoidable. That is not The “if” clause so. makes total design sense whether the (as believes) which “unavoidable” refers is any the dissent design (making feasible the side effects of the used (as avoidable), believe) the vaccine at issuе we particular design (making used the vaccine at issue its unavoidable). effects side Under the latter view, the condi by tion established “if” clause is that the vaccine have properly been labeled and manufactured; and under the for properly designed, that it have been mer, labeled, and manu nullity. factured. view renders “if” Neither clause a preferred two Which variants must is addressed analysis, way our textual and is in no determined “if” clause. argument

Petitioners’ and the dissent’s textual also rests proposition upon 22(b)(1) that the word “unavoidable” in 300aa- incorporates is a term of art that comment k to Re- (Second) (1963-1964).39 statement of Torts 402A The Re- 37Post, at 252.

38Ibid. Brief for Petitioners 29.

234 strictly generally a for liable

statement holds manufacturer by “any product person property in a de- harm to caused unreasonably dangerous fective condition to the user.”40 strict-liability exempts this “unavoid- Comment k rule unavoidably ably products.” product An unsafe unsafe examples, hodge-podge of a defined a criteria and few phar- experimental such as the Pasteur rabies vaccine and clarity, petitioners Despite lack seize maceuticals. this phrase analysis, upon that one comment k and assert majority qua had this a non 1986 courts made sine “unavoidably requirement product”: for an unsafe a case- product “quite specific showing incapable of was being [its] intended made safe ... use.”41 points k. no need consider finer of comment

We have judicial may gloss consistent that comment Whatever given 1986, have there is no reason believe that been 300aa-22(b)(1) invoking it. comment creates was “unavoidably products,” special category of while the unsafe to “side effects were That statute refers unavoidable.” adjective the former uses “unavoidable” and latter “unavoidably” does not establish that the adverb 40 §402A, at 347. Restatement 41 k, alia, Id., 353; inter Kearl v. Lederle cite, petitioners Comment 828-830, 453, Labs., 812, Rptr. (1985); App. 3d 218 463-464 172 Cal. Cal. Hansen, (Colo. 1983). 118, 122 Blood Bank v. Belle Mem. P. 2d 665 Bonfils pertinent point analysis, large to our we that a Though out it is k, disagreed reading with of comment and took number courts not face say did strict side effects that manufacturers drugs accompanied by prescription were ade properly manufactured Court, e. g., See, Brown v. Superior Rptr. 768, warnings. 227 Cal. quate 1986) (officially (Cal. depublished), 1049, 44 aff’d 3d 751 App. Cal. 772-775 Moore, (Okla. McKee v. v. 1982); Stone (1988); 21, 648 P. 23 2d 2d P. 470 Labs., (Ala. Smith, French Lind 1984); 447 So. 2d 1301, 1303-1304 Kline & (CA2 1980) Corp., 87, 90-91 637 say v. Ortho Pharmaceutical (apply F. 2d Co., Wolfgruber Upjohn 59, 61, v. App. Div. 2d ing law); Y.N. Co., G. (1979); v. Chambers D. & Searle Supp. 377, F. Y. S. 2d N. (CA2 Sterling Drug, Inc., Basko v. 1975); (Md. 416 F. 2d 380-381 law). 1969) (applying Conn. k in mind. comment had “Unavoidable” is hardly rarely Even the word. cases petitioners used cite as a de- putting k use the on comment finitive gloss precise phrase “unavoid- unsafe none product”;42 attaches ably special significance to term “unavoidable” alone. standing The textual problems petitioners’ interpretation do not end there. The “even phrase though” in the clause “even though was properly prepared [la- is meant signal beled]” unexpected: unavoidable side despite persist effects best manufacturing labeling prac- But petitioners’ tices.43 reading eliminates any opposition the “even though” between clause —called a concessive sub- ordinate clause by grammarians the word “unavoid- —and Their able.”44 makes reading pre-emption turn equally on unavoidability, proper preparation, and proper labeling. the dissent Thus, twice refers the requirements of proper and proper as “two preparation labeling additional prerequi- for pre-emption sites” of independent unavoidability.45 The textual primary justification the dissent’s position de- 42See, g., Cyanamid e. Johnson v. Co., American 279, 239 Kan. 285, 718 1318, (1986); P. Labs., 2d v. Feldman Lederle 429, 440, N. J. 446- 447, 374, 380, (1984); 479 A. 2d 383-384 Belle Bank, Mem. Blood Bonfils 121-123; supra, Co., at v. Maytag Cassisi 1140, 1144, So. 2d 4, 1146 n. (Fla. 1981); App. Utterman, (Mo. Racer v. 387, 393 629 S. W. 1981). 2d App. 43The dissent’s assertion that we treat “even though” as a synonym for “because” misses the subtle distinction between “because” and “despite.” post, at n. 14. “Even though” is a close eousin of the latter. (2d See Webster’s New International Dictionary 709, 1957). ed. The “the ear statеment accident was despite unavoidable quick his reflexes” quick indicates that reflexes could not avoid accident, open leaves (1) possibilities: other, two unstated unstated avoiding means of quick existed, accident besides reflexes up but came well; short as or (2) quick possible only way reflexes were the to avoid the accident. 300aa-22(b)(1) interpretation of explains Our why we Congress think meant the latter in this (Incidentally, context. the statement “the car accident was unavoidable quick because his sense.) reflexes” makes no Follett, (1966). See W. Modern Usage: American A Guide 61 45Post, at 265. linking independent independence.46

pends on that But job coordinating junction “and,” is of a like not a ideas subordinating junction though.”47 “even like interpretation

Petitioners and dissent contend that 300aa-22(b)(1) part superflu propose we would render tersely clearly pre more and more ous: could have design-defect empted by barring “if . claims . . the prepared accompanied by properly was vaccine was intervening warnings.” passage proper directions and (“the injury or death resulted from side effects that were unnecessary. enough. though”) even True unavoidable against portion giving interpreta text the rule But superfluous prescribe it does not that a tion which renders passage been which could have more terse does not mean verbosity applies only prolixity says. if it The rule what offending passage, giving the can be eliminated competing interpretation. text, That remainder petitioners’ sure, here.48 To be and the ease dissent’s not the meaning gives independent interpretation intervening (the k); meaning supposed passage comment but does so rendering provi only expense the remainder of the “quite superfluous. incapable Since a is not sion manufacturing [its] being if intended use” de made safer warnings pro- eliminated have been or better fects could 46Post, 251-253. at 47 prerequisites” responds that these “additional act “in a The dissent (internal fashion,” pоst, quotation subordinating at n. 14 concessive, omitted). But that more is no true of dissent's marks and brackets present provisions it is text than of all interpretation conjunctive we requirements meaning that could set eliminate that forth additional — lexicon, per English being entirely our its function though” “even No, though” “even has we think distinctive conces- by “and.” formed play. subordinating role to sive, 48 superfluity own, problem of its its dissent has reliance Because LLC, (2005), misplaced. 544 U. Agrosciences S. 431 is See on Bates v. Dow interpretation only an that was “the one id., (adopting makes 449 at statute). relevant in the phrase” of each sense though” append- the entire “even vided, clause is useless say injury “if age.49 It would suffice or death resulted stop. were from side effects unavoidable”—full Ill regulation structure of the NCVIA and of vaccine 300aa-22(b)(1) general the text suggests. reinforces what spells manufacturing A license out the vaccine’s method that warnings must followed the directions and that must accompany product.50 ordinarily Manufacturers must (FDA) Drug Pood approval obtain the Administration’s modifying either.51 before Deviations from the license thus objective provide manufacturing evidence of defects or inad warnings. objective equate Further evidence comes from regulations FDA’s than 90 of perva them52—that —more sively regulate manufacturing process, down to the re quirements plumbing systems and ventilation at each manufacturing facility.53 noncompliance Material any any regulation, them, one or with other FDA could cost regulatory-compliance the manufacturer its defense.54 Design single contrast, do not defects, merit a mention regulations. in the NCVIA the FDA’s Indeed, the FDA spelled regulations out has never even the criteria it uses decide whether a vaccine is safe and effective for its in- surely easy use.55 And the decision tended one. Drug often could efficacy manufacturers trade a little less §300aa-22(b)(1) regardless That is true of whether incorporates com k, k. 402A, ment See Restatement Comment (noting “unavoidably products” exempt unsafe are from strict “with the they qualification properly prepared marketed, are proper warning given”). 314.105(b) §262(a), (j); (2010). §§ 601.2(a), See U. S. C. 21 CFR §601.12. seq., seq. et 820.1 et 600.10-600.15, 600.21-600.22, §§211.1 See §§211.46, See 211.48. §300aa-22(b)(2).

54 See 42 U. S. C.

55 Hutt, Grossman, Merrill, Drug Law, at 685, & Food and 891. always safety, design is not more but safest

for a little safety Striking right one. balance between the best respect efficacy especially which vaccines, difficult with public Act, as health. Yet the which affect well as individual every respect micromanages other silent manufacturers, designs. competing to evaluate Are manufacturers on how only failing employ design for an alternative liable (an approval approved FDA has for it takes the years distribution obtain56)? design it suffice that a Or does vaccine approved in other countries? Or could there be has been design only for in a failure to use a exists lab? provide regulations answer, the Act the FDA an Neither nor only designs leaving the of alternative to be universe limited expert’s imagination. questions Jurors, course, often decide similar with little suggest guidance, guidance we do that the absence guidance suggests pre-emption. But the lack of alone guidance design defects combined with the for the extensive liability specifically grounds of mentioned in Act two suggests strongly defects were not mentioned they liability. are not basis for because Act mandates contained in the lead to same con- broadly Design-defect speaking, torts, have two clusion. (1) prompting development improved effects: beneficial (2) providing compensation injuries. designs, for inflicted achieving provides other means both effects. The NCVIA generous already compensation the Act’s discussed We have many provides improving means of Act And the scheme. Secretary design. It directs Health and development promote “the of childhood Services Human in fewer and less serious adverse reac- result vaccines Program, Vaccine whose National It establishes tions.”57 optimal prevention of human infec- achieve is “to Director оptimal prevention against and to achieve ... tious diseases Willian, Vaccines, Supplying & 66-67. Sing 300aa-27(a)(1). C. U. S. Program priorities reactions.”58 The is to set adverse for research, and to federal vaccine coordinate federal vaccine efficacy safety testing.59 requires The Act vaccine man- providers report and healthcare ufacturers adverse side provides monitoring safety for effects,60 and of vaccine through eight managed-care organiza- a collaboration with And of course whenever the tions.61 FDA concludes that a may unsafe, vaccine is it revoke the license.62 provisions agency improvement federal These for of vac federally prescribed design, compensation, cine once §300aa-22(b)(1)’s again suggest that regarding silence design-defect liability not was inadvertent. It instead re complex a sensible choice to epidemiological flects leave judgments design about vaccine to the FDA and the Na Program juries.63 tional Vaccine rather than finally, pro quid quo And the Act’s structural leads to the same The vaccine conclusion: manufacturers fund from their compensation program informal, sales an efficient for vaccine injuries;64 exchange they costly litigation avoid tort 58 §300aa-1. §§300aa-2(a)(1)-(3), See 300aa-3. §300aa-25(b). See 61See NVAC 18-19. §601.5(b)(1)(vi) (2010).

62 See21 CFR just quotes part sentence, 63 The dissent of this appear make it complex epidemiological we judgments ought believe assigned 274. post, fashion. at We do state our preference, but merely Congress’s expressed preference note in order to —and preclude the argument that it is absurd to think Congress enacted such a thing, we assert the choice is and express reasonable some of the (or why. not) Leaving jury may reasons it to the may be reasonable as well; express we no view. 300aa-15(i)(2); 323(a), See 42 U. S. C. 100 Stat. 3784. The dissent’s unsupported speculation that demand in the vaccine market inelastic, 272-273, post, see n. light sheds no on whether Congress regarded quid the tax pro quo, as a most being Members of profes neither sional nor economists law-and-eeonomies scholars. design- disproportionate jury occasional But verdict.65 allegations speculative type are the difficult

defect most litigate. products-liability Taxing claim manu- product compensation program, to fund the while facturers’ leaving virtually unaltered, their defect hardly back into would coax manufacturers the market. The dissent the Act’s mandates be- believes are irrelevant they way precisely spur in cause do not innovation the same systems.66 suggestion. That is a as state-law tort novel Although previously expressed Congress we have doubt that quietly products-liability pre-empt pro- claims would without viding a substitute, Medtronic, Lohr, v. federal see Inc. 518 (1996) (plurality opinion), S. 486-488 we have never U. skeptical suggested pre-emption of unless we would be operated system. congressional like the substitute tort We today. adopt stance The that belief decline dissent’s that Program FDA and the National Vaccine cannot alone adequate probably questionable, spur vaccine innovation surely point. beside but

IV 300aa-22(b)(1) interpretation only of is the in our Since by supported terpretation the text and structure of the legislative history us of who even those believe is a NCVIA, statutory interpretation legitimate of no need tool have any case, the In dissent’s that it to it. contention resort our conclusion is mistaken. would contradict legislative history following syl- relies The dissent’s Report logism: House Committee A states 1986 300aa- 22(b)(1) principle k forth contained in “sets Comment of (Second);”67 Restatement Torts 402A Section “commonly require k was understood” 1986 comment 65 1(a)(2), §§300aa-1 42 300aa-22. C. See U. S. post, 269-272. (hereinafter 99-908, (1986) pt. Report). p. Rep. H. R. No. showing case-specific design” that “no feasible alternative §300aa- therefore have existed; must intended showing.68 require syllogism ignores unhelpful Report upon statements the 1986 and relies not exist in art did 1986. term

Immediately quoted language after the dissent, Report difficulty jury notes the the 1986 would have in faithfully assessing whether a feasible alternative “young badly injured child, when an innocent often exists plaintiff.69 Eliminating why killed,” is that concern is Report’s “strongly believ[e] authors the 1986 that Com necessary appropriate policy k as the ment for civil damages seeking interpre in tort.”70 The actions dissent’s §300aa-22(b)(1) principle and its version tation of “the adopted Report K” the 1986 Comment leave con unaddressed. cern piece legislative another

The dissent buries unfavorable history. Report §300aa- Because believes that incorporate principle in should “the K” Comment generous provides compen the Act a and because no-fault Report injured parties scheme, the 1986 sation counsels prove manufacturing labeling a who cannot or defect to compensation recompense “pursue system, in the not system.”71 ‍​​​‌​​‌‌​‌‌​‌​​​​‌​​‌​​​‌​‌‌​​‌​​‌‌‌​​​‌‌‌​​‌​​​‍interpretation That counsel echoes tort our 300aa-22(b)(1). worry, Report by retorts, Not to the dissent Committee “authoritatively]” Congress interpreta- a later vindicates its 68Post, at 255-257. (“[E]ven 26; see ibid. if Report, at 69 1986 defendant manufacturer anyone

may reasonably as expect, have made safe a vaccine as could undoubtedly will jury or find difficult to rule favor of court the ‘inno equally manufacturer if ‘innocent’ has cent’ child to bear the risk possibility recompense”). no other loss with 70 Ibid.

71 Ibid.

242 (a legislative history

tion.72 Post-enactment contradiction terms) statutory interpretation. legitimate not a tool of (1999); States, v. 526 U. S. United 227, Jones United (1947). Workers, 258, Mine 330 U. Real States v. S. 281-282 history persuasive (pre-enactment) legislative to some be- light legislators thought shed under- cause it is on what ambiguous statutory they stood an text to when voted mean Corp. Allapattah into to enact it See Exxon Mobil v. law. (2005). post-enactment Inc.,

Services, But U. S. legislative history by definition had on “could have no effect congressional vote,” Heller, District v. Columbia (2008). U. S. 300aa-22(b)(1) not

It not matter did take effect does passed until later that funds the excise tax compensation supposedly dispositive scheme,73and that Report funding legislation.74 is attached to that Committee statutory language the relevant voted on were Those who necessarily persons who the same crafted the statements Report; they or if were did not neces in the later Committee sarily views at time; the same that earlier and no one have possibly voting time at that earlier could have been informed Permitting legislative later statements. his those subsequent funding legislation meaning tory to alter the precedent. dangerous Many provi would set aof statute depend appropriations law include sun federal sions of they cannot be made the un- provisions;75 device for set statutory revision. enacted courageous previously is a adverb since we Post, This have at 261. statutory meaning source of is the text only authoritative

held that Corp. See Exxon Mobil process. Article I through the v. passed that has (2005). Inc., Services, 546, 545 U. S. 568 Allapattah 73 323(a), Stat. 3784. 100 (1987). 100-391, pt. 1, p. 701 Rep. No. H. R. 403(a), 3009-656, 110 Stat. §§401, 3009-655 to 3009-659 See, e.g., (2006 amended, following ed., Supp. note 8 U. S. C. 1324a 3009-662, as 2012). expires Sept. 30, III) (E-Verify program brings syllogism: us to second flaw in the dissent’s That “commonly k not have a did understood mean- Comment thought required ing”76 courts in the mid-1980’s. Some it showing product case-specific “unavoidably that a was un- many thought categorically exempted others safe”; certain (or liability.77 products types nearly from strict “all When all) judicial given relevant of the” decisions have a term or judicial gloss, presume concept a consistent we in- concept meaning term or to have tended the when it incorporated it into later-enacted statute. Merck & Co. v. (2010) Reynolds, concurring U. J., S. (Scalia, concurring judgment). part gloss consistent represents public understanding of the term. We cannot assumption widespread disagreement same when make the among giv- courts. We must make exists lower do with plausible meaning using ing term its most the traditional statutory interpretation. tools of That is what we have today done

[*] ^{[*] [*]} foregoing we reasons, For the hold that the National Injury pre-empts design-defect all Childhood Vaccine Act against brought by plaintiffs vaccine manufacturers claims compensation injury seek or death who caused vac- judgment Appeals cine effects. The Court of side affirmed.

It is so ordered. Kagan Justice took no part consideration or deci- case. sion this Breyer,

Justice concurring. join opinion. judgment my I In Court’s view, purely argument. has the better of the Court textual But question the textual considered alone is a close one. Hence, 76 Post,at 257. 39, supra; post, See n. n. 5. including leg- sources, I look to dissent,

like the would other history, statutory purpose, and views of the fed- islative the agency, supported expert here medi- eral administrative opinion. I dissent, these however, cal Unlike the believe the other conclusion. sources reinforce Court’s

I Report 99-908 contains an “authori- House Committee No. Congress’ drafting pre- intent in the tative” account of emption Injury Act clause of National Childhood Vaccine (NCVIA Act). States, 469 or See Garcia v. of 1986 United (1984)(“[T]he finding authoritative U. S. source Reports Legislature’s in intent lies the Committee bill”). says vaceine-injured persons Report “if” That applicable under law either that

“cannot demonstrate improperly prepared was or that it was accom- vaccine inadequate warnings panied improper or directions recompense pursue [they] compensation should system.” Rep. system, not the tort H. R. 99-908, No. (1986)(hereinafter Rep. Report). pt. p. 26 H. R. specific Report suits two kinds of tort that the lists The (suits improper pre-empt based on manufac- clause does going improper labeling), while on to turing state that g., design-defect compensation claims, claims, for other tort e. system, compensation no-fault] [NCVIA’s not in “the lies system.” Ibid. tort contrary argument upon Report’s strongest rests “set[ting] prin- description forth of the statute as

earlier (of k” ciple Restatement Second Comment contained 402A) “a manu- section, strict of Torts’ injuries resulting liable for or deaths not be facturer should added). (emphasis Id., effects.” аt 25 side unavoidable last- appearance of word “unavoidable” this But the petitioners provide much cannot sentence mentioned nothing Report suggests in the help. because That the word means “unavoidable” summon the statute up unmentioned third exception otherwise suits encompassing can the based oh defects. Nor reference to Report’s k fill The refers, comment itself com- gap. Report “principle” to its details, only ment fc’s but namely, vac- should not liable cine manufacturers held for unavoidable It at all about says nothing injuries. judge, jury, who — federal decide whether a safety agency safer vaccine —should Indeed, could have been designed. at the time Congress this different wrote state courts had Report, come to very different conclusions about that matter. Re- Cupp, Conscious Design Liability for thinking Prescription Drugs: (Third) The Restatement Standard Versus Negligence Ap- (1994-1995) (“[Cjourts 63 Geo. Wash. L. Rev. 76, proach, adopted a broad of range conflicting [had] interpretations” k). of comment Neither the word “unavoidable” nor k” “the Comment phrase tells us which principle courts’ view Congress intended Silence cannot tell us to adopt. follow those States where juries decided the design-defect question.

II history describes the statute more legislative gener- of children, as ally lives trying protect part end- “the ing instability unpredictability childhood ante, 7; H. R. vaccine market.” see at Rep., 227-228. As clear, makes routine vaccination “one of Report most effective health spectacularly public initiatives this H. has ever undertaken.” R. at 4. country Rep., Before the of routine development cough vaccination, for exam- whooping “nearly all children” in the United ple, States caught dis- 4,000 ease and more than annually, died most of them people infants. U. S. Health and Human Dept, Services, Centers Prevention, for Disease Control and Would What Happen if We Stopped Vaccinations? http.7/www.cdc.gov/vaccines/ (all Internet materials as visited vac-gen/whatifstop.htm 2011, and available file); Feb. in Clerk of Court’s case Preventing Diphtheria, Among Ado- Tetanus, Pertussis Diphtheria Toxoid, Use Reduced Toxoid lescents: of Tetanus Morbidity Mortality Vaccines, and Acellular Pertussis (hereinafter (Mar. 2006) Weekly Report, p. 2 RR-3, No. Tetanus) (statistics 1934-1943), http://www. Preventing Dept, cdc.gov/mmwr/PDF/rr/rr5503.pdf; U. S. Health and Services, Human for Disease and Preven- Centers Control Epidemiology and Prevention Vaccine-Preventable tion, 2009). (11th May Diseases rev. After vaccination ed. be- whooping cough of annual came number cases common, from over and the 200,000 2,300, declined to about number of Preventing to about 4,000 deaths from about 12. Tetanus Energy 2; Commerce, House Committee on Childhood (Comm. 1986) Cong., Sess., Immunizations, 99th 2d Print (hereinafter Immunizations). Childhood fragile; agents “[t]he gains are

But these causative present preventable childhood illnesses are ever these waiting opportunity environment, attack Hearing unprotected S. individual.” on before the on Labor and Human Committee 99th Resources, Senate (hereinafter (1985) pt. pp. Cong., 20-21 Sess., 2, 1st Hear- Academy (testimony Pediatrics); ings) of the American of (Jan. Dept, Report Public of Pertussis Health, see California 2011), www.cdph.ca.gov/programs/immunize/Documents/ (In people PertussisReport2011-01-07.pdf 2010,8,383 in Cal- died). whooping cough, caught and 10 infants Even ifornia disrupted programs period are when vaccination can a brief Hearings Gangarosa 20-21; see deaths. children’s lead Impact of Anti-Vaccine Movements Pertussis Con- al., et (Jan. 1998) Story, 356-361 Lancet trol: The Untold (when disrupted, programs are the number of vaccination cough skyrockets, increasing whooping orders of cases magnitude). Congress sharp considering NCVIA, found that In against brought whooping cough and suits in tort increase manufacturers between and 1985 had vaccine other question par- their “prompted manufacturers continued Rep., ticipation in the vaccine market.” H. at 7; . R. Child- whooping cough Indeed, 85-86. Immunizations two hood from the market, withdrew manufacturers vaccine other “fac[ing] great difficulty obtaining manufacturers, vaccine liability] Congress they [products insurance,” told were considering Rep., course of action.” R. “a similar H. at 6; Report The Immunizations 68-70. Committee Childhood explains only one there were that, since two manufactur- any “[t]he many vaccines, loss of childhood ers exist- ing vaccines manufacturers childhood . . . could create a present public genuine very hazard”; health “would shortages, possibility increasing and, turn, real perhaps, children, and, of unimmunized numbers resur- preventable Rep., gence of diseases.” H. R. at 5. At the sought provide generous compensa- time, same injured to those vaccines whom tion determined —as compensation program. expert Id., at 5, 24. general purposes, pre-

Given these broad to read the emption preserving design-defeet as clause suits seems Department anomalous. Health and Human Services (HHS) enough safe decides when vaccine is to be licensed injuries, which vaccines, licensed with which associated placed Injury on the Vaccine should Table. 42 U. S. C. Comprehensive ante, A 800aa-14; 228; Review of Fed- Safety Programs eral Vaccine and Public Health Activities (Dec. 2008), http://www.hhs.gov/nvpo/nvac/ 32-34 13-15, documents/vaccine-safety-review.pdf. special A master in compensation program Act’s the determines whether some- injury Injury has one suffered listed the Table and, injury. not, whether the vaccine if nonetheless the caused §300aa-13. jury Ante, 228; To allow a effect to second-guess those determinations is to substitute less ex- expert judgment, pert thereby threatening for more manu- liability (indeed, liability) facturers with strict in instances any experts nonexperts likely where conflict between is in- severe —instances where to be particularly the is because tort That contrary. potential tended plain- to unless the are suit unlikely specialized compen- tiffs bring has they determined are not entitled sation program (say, because concludes that the vaccine did compensation Amicus the Brief injury). not cause United States as (“99.8% Curiae of successful Compеnsation Program their tort awards, claimants have accepted foregoing any manufacturers”). against vaccine It difficult to remedies the reconcile these conflicts and tort lia- potential resulting statute seeks diminish manufacturers’ bilities the while role simultaneously augmenting products of decisions. experts making compensation

Ill States, reflecting HHS, the views of the urges The United I the Act as and the would to read do. It majority Court listed vaccines have compensation program’s Brief). (hereinafter Academy AAP The American Curiae supported has also retention of vaccine of Pediatrics liability (provided tort that federal manufacturer law struc- ways liability conditions in state-law would take tured agency safety). about proper of federal views account Hear- ings respect us here, But it nonetheless tells 14-15. to question petitioners’ specific interpre- us, before that the purposes by Act undermine basic of the would its tation threatening production development to “halt the future and country,” by “threatening] e., in this vaccines i. childhood resurgence very problems of the which... caused (inter- by enacting AAP this statute. intervene” Brief 24 omitted). quotation marks nal give significant weight to the views of

I would HHS. The charges responsibility overseeing HHS with law safety. “likely production thorough and It is to have a un derstanding” complicated subject and technical matter policy, comparatively “quali of immunization more likely comprehend impact requirements.” state fied Co., v. American Honda Motor Geier U. S. 861, 883 (internal (2000) omitted); quotation marks see Medtronic, (1996) concurring Lohr, 470, 506 J., Inc. v. U. S. (Breyer, (the part concurring judgment) agency inis (or which) position best determine “whether extent to may requirements objectives”). interfere with federal state particularly persuasive position expert here HHS’ because organizations support public health its views and the matter question great impor concerns a medical scientific how best save the lives of children. tance: See Skidmore (1944). Co., U. S. v. & Swift congressional reports history,

In sum, the statute’s history, purpose as revealed basic and the views of expert agency along with those of relevant medical and support all associations, scientific the Court’s conclusions. consequently agree with the Court. I Ginsburg whom Sotomayor, with Justice

Justice dissenting. joins, long subject legal been to a

Vaccine manufacturers have duty, principles products law, rooted in of basic designs improve light of their vaccines of advances in technology. today, duty that Until was enforce- science through a traditional state-law tort action for able defective § design. holding In that of National Childhood (Vaccine Act), Injury Act Act or 42 U. S. C. Vaccine 300aa-22(b)(l), § pre-empts inju- all defect claims stemming Act, covered from vaccines under ries imposes preference policy its own over the con- bare Court doing judgment Congress. In Court so, the ex- sidered statutory text, 13 words from misconstrues the cises history, legislative and disturbs the careful balance Act's vaccine-injured compensating Congress struck between chil- stabilizing the vaccine childhood market. Its deci- dren regulatory vacuum in which one leaves a no ensures sion adequately take vaccine manufacturers account scien- technological designing advancements when or dis- tific and tributing products. nothing Because in the their text, history legislative remotely of the Vaccine Act structure, or respect- a such I suggests result, intended fully dissent.

I A “ provides [standards the Vaccine Act re- Section against govern civil actions vaccine manufac- sponsibility” to 22(a) § 300aa-22. forth C. Section sets S. turers. U. apply civil that “State law shall a action “[gjeneral rule” damages injury brought for vaccine-related or death.” 300aa-22(a). applies baseline rule that state law This §22(b)(1), exceptions, which, subject one of narrow to three 22(b)(1) provides: case. Section this issue in is at shall be “No vaccine manufacturer liable in civil ac ‍​​​‌​​‌‌​‌‌​‌​​​​‌​​‌​​​‌​‌‌​​‌​​‌‌‌​​​‌‌‌​​‌​​​‍ arising damages injury from a tion for vaccine-related associated the administration of or death injury 1988, if October or after death resulted though side effects were unavoidable from even properly prepared accompanied by vaccine was and was 300aa-22(b)(1). warnings.” proper directions key provision injury contains two clauses: “if the (the resulted side effects were death unavoidable” clause), though properly pre- and “even “if” the vaccine was accompanied by pared proper and was directions and warn- (the clause). though” ings” “even products liability generally recognizes

Blackletter law types product design defects: defects, three different ufacturing man- labeling (e.g., defects, and defects failure to warn).1 though” The reference in “even clause to a “properly prepared” “accompanied by proper vaccine direc- warnings” reference tions and is obvious such to two de- manufacturing labeling plain defects. The terms fects— 22(b)(1) though” § ap- clause of the “even thus indicate that only present. plies neither where kind of defect Because 22(b)(1) § by a invoked vaccine manufacturers as defense liability, though” to tort follows that the “even clause re- quires a vaccine manufacturer in each civil to action demon- manufacturing strate that its is free from and label- § ing liability 22(b)(1).2 exemption to fall within the defects though” requires “even clause Given the absence manufacturing labeling defects, the “if” clause’srefer- to ence “side effects that unavoidable” were must refer to Keeton, Dobbs, Owen, & D. R. Keeton, 1 W. D. Prosser and Keeton on (5th 1984). of Torts 695 ed. Law Corp., Kerr-McGee 238, 255 (1984); v. Silkwood Brown v. U. S. USA, Inc., (CA6 (“ Sports 2007) Earthboard 481 F. 3d ‘[F]ederal upon preemption is an affirmative defense which defendants bear the ” Corp., Bank CSX proof’ v. Third (quoting 415 F. 3d 741, burden Fifth (CA7 2005))). something manufacturing by other effects caused than side only remaining product labeling kind defects. recognized products traditional law is defect under design a “side effects that were defect. unavoidable” Thus, design caused must refer side effects vaccine’s §22(b)(1) “unavoidable.” uses the conditional were Because plainly implies text side “if,” moreover, term that some stemming a vaccine’s are “unavoidable,” effects others avoidable. See Webster’s Third Inter- while are New (2002) (“if” Dictionary 1124 means “in the event national that”). long Accordingly, that,” as,” “so or “on condition be- clause) (like though” cause “if” clause the “even sets 22(b)(l)’s § liability, forth a condition invoke defense tort Congress must also intended a vaccine manufacturer have particular action that the demonstrate each civil side ef- design were of a vaccine’s “unavoidable.” fects Congress’ pro- “if” of conditional clauses in other use two supports Act of the Vaccine the conclusion visions § inquiry requires an each case which manu- provision’s exception to invoke the to state facturer seeks 22(b)(2), liability. presumption In created tort 22(b)(1), presumed purposes of “a vaccine shall that, warnings accompanied proper directions and if to be complied that it in all shows material manufacturer requirements. labeling respects federal with” U. S. C. 300aa-22(b)(2). § Similarly, 23(d)(2), Congress § created punitive “[i]f damages exemption from . . . the manufac- an complied, respects,” it in all material turer shows engages laws, “fraud,” “inten- applicable unless federal withholding wrongful of information” from federal tional and §300aa- illegal activity.” or regulators, “other criminal or 23(d)(2). highly Congress anomalous for to use would It 23(d)(2) 22(b)(2) §§ to clause re- “if” a conditional inquiry using in each quire specific case while same a 22(b)(1) § categorical “if” clause in to denote conditional liability. exemption Erlenbaugh Cf. v. States, United (1972)(“[A]legislative body generally 239, 243 409 U. S. uses particular meaning given word with a consistent a context”). in a Congress pre-empt design intends

Indeed, when de (e. categorically, using categorical g., claims it does so fect (e. “all”) language g., “shall”), and/or declarative rather (“if”). example, term than conditional For in a related Congress Secretary has context, authorized the of Health designate designed Human Services a vacсine pandemic epidemic prevent a as a “covered countermeas §§247d-6d(b), (i)(1), (i)(7)(A)(i). ure.” U. S. C. With re spect to such “covered pro countermeasure[s],” subject exceptions, vided that to certain person “a covered immune shall be from suit and under Federal and respect law with to all by, State claims for loss caused arising relating resulting out of, to, or from the adminis countermeasure,” by tration or the use an individual of a covered -6d(a)(1) (emphasis added), §247d including specifi cally relating design” claims to “the of the countermeasure, 247d-6d(a)(2)(B). § plain text and structure of the Vaccine Act thus com 22(b)(1) §

pel pre-empts conclusion some—but not design Contrary majority’s defect claims. to the all— respondent’s categorical reading, petitioners correctly con plaintiff proved where a that, tend has that she has suffered injury resulting from a side effect caused vaccine’s design, 22(b)(1)’s may a vaccine manufacturer invoke liabil ity exemption only if it demonstrates that the side effect stemming particular from the vaccine’s is “unavoid able,” and that the vaccine is otherwise free from manufac turing labeling defects.3 question This leaves precisely of what means “unavoid effects, side I

able” which address in the next section.

B interpretation legislative history petitioners’ The confirms light pre-emptive scope. of and further sheds its Report Energy The Committee accom- House and Commerce (1986) pt. Rep. panying the H. Act, 99-908, R. No. Vaccine (hereinafter Report), explains part: in relevant (b) Adverse Side

“Subsection Effects; —Unavoidable Warnings. provision princi- Direct forth sets —This ple of in Comment k of Section 402A the Re- contained (Second) that a of Torts vaccine manufacturer statement injuries resulting not or deaths should be liable though effects even the vaccine was unavoidable side accompanied by properly proper prepared and directions warnings. has set forth K in “The Committee Comment this bill principle it in Comment K intends re- because 'unavoidably products, prod- garding unsafe’ i. e., those present in state of human which skill and ucts knowledge apply to the safe, made cannot vaccines products in bill that such not be covered system.” subject Id., at of the tort 25-26. §402A expressly Report adopts comment k of of (Second) (1963-1964) (hereinafter Torts of the Restatement Restatement), provides “unavoidably which unsafe” present products e., those “in the state of human —i. incapable being quite knowledge, safe made for their are ordinary “[a]n use”—are not defective.4 As intended k as provides follows: Comment products. There “Unavoidably which, products are some unsafe knowledge, being quite incapable of human are made present safe state ordinary especially are use. These common intended for their outstanding example is the for the An Pasteur drugs. field of rabies, uncommonly very leads to serious and dam- which treatment injected. invariably Since the itself when disease consequences aging death, marketing both and the use the vaccine dreadful leads to a degree notwithstanding high risk the unavoidable fully justified, are outstanding example” “Unavoidably product, of an unsafe” k “the comment cites the Pasteur treatment uncommonly very which rabies, not leads to of serious and consequences injected”; damaging “[s]ince when is the dis- invariably a itself leads to dreadful ease both death, the mar- fully keting justified, the use of the vaccine are and notwith- high standing degree they the unavoidable of risk which provides thus Id., involve.” at 353. Comment k that “sell- “Unavoidably products [s]” er unsafe” are “not to be held liability” provided products properly to strict that such “are prepared proper warning and given.” marketed, and is Ibid. explains, Report

As the 1986 intended that the “principle regarding ‘unavoidably in Comment K unsafe’ products” apply to the vaccines covered the bill. 1986 Report 26. That plain intent, turn, is manifested in the particular, Congress’ text of use of the word —in phrases “properly “unavoidable,” as prepared” well as the by proper “accompanied warnings,” and directiоns and which nearly taken were verbatim comment k. 42 U. S. C. (“Such §300aa-22(b)(l); a[n see Restatement 353-354 un avoidably product, unsafe] properly prepared, accompa and they product, properly which involve. Such a prepared, and accompanied defective, proper warning, directions and not is nor is it unreasonably dangerous. many drugs, vaccines, The same is true of other like, and the many very of which for legally this reason cannot except physi- sold cians, prescription physician. or under the of a It is particular also true in many experimental new or drugs which, as to because of lack of time opportunity and for sufficient experience, medical there can be no assur- safety, perhaps purity ance of even ingredients, but such experi- justifies ence marketing as there is of the drug use notwithstand- ing medically recognizable risk. The products, seller such again with qualification they properly are prepared marketed, warning proper given, is it, where the situation calls for is not to be held liability for consequences to strict unfortunate use, attending their merely supply because he has public undertaken with apparently useful product, and desirable attended apparently known but reasonable risk.” Restatement 353-354. defective”).

nied directions and proper warning, numer time Act’s enactment By Vaccine comment k ous state and federal courts had interpreted mean that product when, unsafe” “unavoidably given manufacture and no alternative de proper labeling, feasible reduce the sign would risks without safety compromising in cost Given product’s utility.5 Congress’ expressed 5See, g., Labs., Inc., Wyeth Smith ex rel. 84-2002, e. Smith v. No. A Civ. (SD 21, 1986) (“[A] 720792, Va., Aug. prescription drug 1986 WL *5 W. ‘unavoidably dangers through not unsafe’ when its can be eliminated de unduly Lederle sign changes utility”); do not its v. Kearl affect cost or Labs., (1985) (“unavoid- App. 812, 830, Rptr. 453, 172 3d 464 Cal. 218 Cal. “(i) ability” product designed on the turns whether was to minimize —to scientifically the the extent at time it was distributed —the risk knowable (ii) any product, availability ... inherent in and the оf alternative the effectively pur as have intended product accomplished that would full pose Superior by Brown subject product”), disapproved part in v. of the Ct., 1049, (1988); Belle Memorial Blood 751 470 44 P. 2d Cal. 3d Bonfils 1983) Hansen, (Colo. 118, (“[Ajpplieability P. v. 665 122 of Bank 2d com upon factors,” including k depends . the co-existence of several ment . . manner; must in benefits not be achievable product’s that “the another present knowledge”); under the state of see risk be unavoidable must & M. 8.07[1]-[2], Friedman, Liability §§ 1 L. Frumer Products also (2010) (comment k applies “only to in design,” defects pp. 8-277 to 8-278 no alternative which balance design be feasible accom and there “must (internal product’s purpose quota with a risk” subject lesser plishes the omitted)). sure, To of courts at time of number tion marks k preclude interpreted design had comment enactment Vaccine Act’s Hill Searle categorically products, for certain kinds of see v. defect claims (CA8 1989) 1064, 1068 cases), (collecting Labs., but as indicated F. 2d comment k above, the cited courts had construed by the sources ease-specific generally agreed on the basic elements basis apply on a 8, “unavoidably product. unsafe” n. also what constituted infra. “judges who rule on suggestion that must motions to dis majority’s The judgment summary motions as a mat judgment, miss, motions alleging adjudicating claims incapable of “unavoidable” side are ter law” many 232, 35, by experience n. is thus belied effects, ante, at adjudicated years such claims for the time of the Vac courts that had cine Act’s enactment. codify “principle Report

tent to K,” Comment 26, 22(b)(1) § term “unavoidable” in is best as a understood incorporates commonly art, which term understood meaning “unavoidably products unsafe” under comment k time of the Act's enactment in 1986. See McDermott (1991) (“[W]e Int’l, Wilander, Inc. v. 498 U. S. as [of that when a Congress sume statute uses ... a term art], meaning”); have intended its established Morissette v. (1952) (same).6 States, 342 U. Similarly, United S. applying long required courts comment k had manufacturers invoking the defense to products demonstrate that their only “unavoidably properly were unsafe” but also manu By requiring “prope[r] factured and labeled.7 preparation]” § “proper warnings” 22(b)(1), directions Congress plainly incorporate intended these additional comment k requirements. Report petitioners' thus interpretation confirms 22(b)(1). Report The 1986 makes clear that “side effects were unavoidable” refers to side effects

stemming from a vaccine's that were “unavoidable.” By explaining what meant the term “unavoid- 6 majority reeognize The refuses to that “unavoidable” is a term of art “ k, from comment suggesting derived that ‘[unavoidable’ is hardly a Ante, rarely fact, however, used word.” at 235. In “unavoidable” is an extremely rare in the word relevant appears context. It exactly once (i. e., 300aa-22(b)(1)) §in in entirety (“Pub 42 of Title of the U. S. Code Welfare”), alia, lic inter governs, Health and which Social Security, see 42 § seq., U. S. C. 301 et Medicare, seq., see 1395 et and several other of the largest Federal Government’s programs. entitlement singular rarity in which used the supports term the conclusion that “unavoid a able” is term of art. 7See, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 652, F. 2d 657 (CA1 1981); Labs., Inc., Needham v. White (CA7 394, 639 F. 2d 402 1981); Reyes Wyeth Labs., (CA5 v. 1264, F. 2d 498 1974); 1274-1275 Davis v. Labs., Wyeth (CA9 399 F. 121, 127-129 1968); 2d Labs., Feldman v. Lederle 429, 448, J. A. 374, (1984); 97 N. 2d 384 Toner v. also Labs., see Lederle 328, (1987). P. 112 Idaho 2d confirms that whether moreover, also able,” 1986 Report §of in- for purposes side effect “unavoidable” to vac- case as whether the specific volves a in each inquiry skill and can- knowledge “in the state of human present cine e., 26 —i. whether a feasible safe,” not be made 1986 Report that would have eliminated alternative existed vaccine without its compromising adverse side effects of the cost and Brief for Kenneth W. Starr et al. as utility. See Amici Curiae (“If 14-15 show could particular plaintiff her at avoidable ... the use through issue was injury for then she vaccine, a feasible alternative design specific statute, she because satisfy [plain] language would the side effects were not un- have demonstrated would avoidable”). confirms Finally, the 1986 Report clause is read to establish two “even addi- though” properly la- manufacturing tional prerequisites proper proper — 22(b)(l)’s liability exemption.8 beling qualify —to 8Respondent suggests reading Report. of the 1986 alternative Ac principle K” is cording respondent, simply “the Comment that of “unavoidably products, nonliability Congress’ unsafe” and thus stated Report “principle apply the in Comment K” to “the intent in the 1986 in the bill” that Congress means viewed the covered vaccines covered ‘“unavoidably 25-26; to be unsafe.’” 1986 Report a class vaccines as 42. argument. a similar Respondent The concurrence makes Brief for J.). (opinion Breyer, interpretation Ante, This finds some 244-245 Report, [injured which states that “if can support individuals] in the law either that a applicable improperly under vaccine was not demonstrate accompanied it was improper inadequate directions or prepared or recompense pursue compensation in the warnings [they] system, should Report 26. It some support also finds system.” 1986 the tort law, disagreement reflected case which considerable pre-Vaccine Act applies pharmaceutical k products comment “whether courts over only case-by-case Ausness, Unavoidably on a basis.” the board across Liability: Liability and Strict Products What Rule Products Unsafe Ky. Sellers Pharmaceutical Products? 78 L. Applied J. Be Should cases). (1989-1990) (collecting This interpretation, 705, 708, n. Congress fact that by the has never however, directed the undermined (FDA) or any Administration other federal to re- Drug agency Food and

259 to the 1986 one other Report, piece addition the Act’s In provides further confirmation of history the pe- legislative 22(b)(1). textual reading Congress When titioners’ Act in it 1986, the Vaccine did not initially include a enacted for the no-fault of payment compensation program the source The Act established. thus “made Act compensation pro- tort reforms and on the en- accompanying contingent gram to of a tax for provide funding the cоmpensation.” actment In 1987, Congress 690. Report passed legislation to the compensation program. fund House Energy and Committee that Report9 accompanying Commerce legisla- stated “the tion codification specifically Comment (Second) (k) The Restatement Torts was not intended as a matter of law the decide circumstances which a should unavoidably be deemed vaccine unsafe.” at 691. Id., noted that The Committee amendment establish “[a]n . .. a manufacturer’s failure to safer develop vaccine was [a] was grounds rejected by Committee dur- infra, design, 269-270, optimal vaccines for see view and n. Congress highly unlikely thus seems and intended eliminate the (i. e., for such mechanism review liability), partic- traditional defect ularly given express its retention of state tort law in Act, the Vaccine see §300aa-22(a). event, any S. C. In to the 42 U. ambiguity extent there is precisely how the “principle intended as Comment K” to vaccines, ambiguity to the apply explicitly covered in peti- resolved favor the 1987 House Energy and tioners’ Commerce Committee Re- (hereinafter 100-391, Rep. pt. 1, H. R. port, pp. No. 690-691 Report). page this and 260-261. See infra opinion expressed The Third uncertainty Circuit’s below as to whether Report authored Budget was the House Committee or the Energy (2009). and Commerce House Committee. See 561 F. 3d explain, although Budget petitioners compiled As Committee and is Report, Energy sued Commerce wrote ap Committee proved language. Report, the relevant Title IV of the 1987 entitled Energy Commerce,” comprises “Committee “two Committee approved by Energy Prints the Committee on Commerce inclusion forthcoming Report 377, in the reconciliation bill.” 380.

260 original light ing of the Ibid. In its Act.” consideration emphasized rejection, that “there should that the Committee misunderstanding the no that Act undertook to decide as unavoidably matter of were law vaccines unsafe whether question “[t]his and that is to the courts to deter- not,” left applicable Ibid. mine in accordance law.” legislative history postenactment To sure, he created ordinarily subsequent Congress is a hazardous basis from Congress. enacting infer of the which to the intent See Sul (1990) 496 U. S. 631-632 Finkelstein, livan v. (Scalia, ordinary concurring part). postenactment J., But unlike justifiably legislative history, given is or no little which Congress weight, Report reflects the intent of the the 1987 necessary funding legislation give oper the that enacted provisions principal the Act, to the Vaccine ative effect 22(b)(1).10 § including had a in 1987 number of including adopting entirely options it, different before Reagan prop compensation as the administration was scheme, establishing liability, osing;11 different limitations on tort ehminating design liability, pharmaceuti including defect as advocating;12 industry funding or not leaders were cal 10 creating the 1987 suggests legislation funding majority appropriations legislation giving weight mechanism akin history legislation dangerous set a prece of such “would legislative Ante, difference, course, that appropriations 242. The at dent.” ordinarily congressional already funds enactments have legislation effect; contrast, operation of the tort reforms in the 1986 legal operative 22(b)(1), expressly § Act, was conditioned on enactment of a including compensation program. 323(a), 100 fund Stat. separate tax to general to view Accordingly, appropriations this Court’s reluctance 3784. g., Hill, e. legislation, see, TVA v. modifying substantive legislation as (1978), bearing has here. no 153, 190 U. S. Report (describing administration’s alternative See 1987 proposal). Funding Hearings Program be g., e. See, Childhood Vaccine on Select Revenue Measures of the House Commit the Subcommittee fore (1987) (“[T]he Means, 1st Cong., Sess., 100th Ways and tee on all, which would program have effectively compensation the relevant of the Act. Because the tort portions nullified 22(b)(1), in the 1986 Act, reforms had no including operative unless and until Congress provided effect legal funding compensation views program, Congress that and, indeed, enacted are funding legislation proper 22(b)(1). § to of authoritative the guide meaning Those as reflected in the 1987 views, Report, provide unequivocal 22(b)(1). § of petitioners’ confirmation of reading sum, text, the structure, In legislative history Act fully petitioners’ are consistent with Vaccine of reading 22(b)(1). 22(b)(1) § I Accordingly, believe exempts § vaccine only tort liability from a upon manufacturers showing by in each case the manufacturer that vaccine the was prop- labeled, manufactured the side erly effects the stemming from vaccine’s could not have design been a feasible alternative design would have prevented the adverse side effects without eliminated compromising and utility. vaccine’s cost the

II 22(b)(1) the of contrast to interpretation In set forth the does above, majority’s interpretation considerable vio- the text, to misconstrues statutory lence the his- legislative and draws the from conclusions the tory, wrong structure Act and Vaceine the broader federal scheme the regulating vaccines. Act be

provisions the 1986 should amended assure that manufactur system they not liable in tort if fully will be found the complied ers have regulations. particular, applicable government In manufacturers ‘design theory face a not under defect’ plain where should cases challenge public the decisions of health authorities and federal regula tiffs protect the way licensed are best available tors vaccines chil (statement deadly Johnson, President, diseases” of Robert B. dren Co.)). Div., Cyanamid Labs. American Lederle A majority’s interpretation of a matter, As textual fundamentally respects. flawed in three central faulty majority’s categorical reading a First, rests functionally premise. reading Second, untenable its excises key statutory including text, term words from the majority entirely ignores third, the “unavoidable.” And preserving state law. Vaccine Act’s default rule tort begin, majority “[a] To states that side effect a vac- always differently could use cine have been avoidable containing designed vaccine the harmful element.” not premise, majority Antе, 232. concludes From statute mean that “the vaccine that the must subject question given, action,” not the tort because §22(b)(1) construing the statute would render otherwise according majority, nullity. A claimant, Ibid. tort differently designed always point able to to a will containing the element,” “harmful and if that were suffi- a that vaccine’s were not “unavoid- cient to show side effects pre-empt nothing. the statute would able,” premise majority’s starting interpretation, how- The fatally Although sense, flawed. in the most literal ever, always majority a can be side effect avoided notes, as the differently containing designed “by vaccine not use of a interpretation ibid., this of “unavoidable” element,” harmful effectively statute, read the term out of the and Con- would 22(b)(1) § gress Indeed, have intended that result. not could phrase injury specifically the conditional “if or death uses effects that were which unavoidable,” side from resulted Congress contemplated there plainly indicates which vaccine’s side are instances effects be would some they in which not. other instances are “unavoidable” majority’s premise supra, 252. The vaccine’s at See by always differently “avoid[ed] be use of can side effects containing ante, the harmful designed element,” vaccine ignores removing entirely the fact that the “harmful 232, at (or entirely result in a will often less effective inef- element” fective) ordinarily vaccine, A nature, vaccine. its em- ploys weakened form a killed or a bacteria or of virus production;13 antibody removing stimulate that bacteria or might element,” virus remove “harmful but it would also necessarily explained render vaccine inert. As above, history legislative the Yaceine Act and the cases inter- preting k make clear that a comment side effect is “unavoid- purposes only able” for where there is no feasible design that would alternative eliminate the side effect of the compromising utility. without vaccine its cost and majority’s premise supra, 256. The side effects —that stemming design always from a vaсcine’s are avoidable—is statutory legislative history text thus belied 22(b)(1). starting premise And because its its invalid, design subject a vaccine conclusion—that is not challenge necessarily in a tort action—is also invalid. majority’s reading suffers from an even more funda- exempt

mental defect. If intended to vaccine categorically liability, from manufacturers all defect logically provided: it more would have “No vaccine manufac- damages arising in a turer shall liable civil action for from injury a vaccine-related or death associated with the admin- of a vaccine after 1, istration October if the prepared properly accompanied ‍​​​‌​​‌‌​‌‌​‌​​​​‌​​‌​​​‌​‌‌​​‌​​‌‌‌​​​‌‌‌​​‌​​​‍ by proper was was di- warnings.” There rections have would no been need Congress to injury include the additional words “the death resulted side effects that were unavoidable even (2001) though.” Inc. Andrews, See TRW v. U. S. (noting principle statutory “cardinal construction that a ought, upon whole, statute to be so construed that, prevented, if it be clause, can no sentence, or word shall Academy Pediatrics, Questions See American of and Answers About (Oct. Ingredients 2008), http://www.aap.org/immunization/families/ Vaccine (all faq/Vaceineingredients.pdf 18, 2011, Internet materials as Feb. visited file). in Clerk of and available Court's case (internal insignificant” quotation superfluous, void, or omitted)).

marks (2005), Agrosciences LLC, In Dow 544 U. S. 431 Bates v. analogous where an ex- this situation Court considered press pre-emption provision stated that certain States “ requirements any impose ‘shall not in effect or continue labeling packaging or or different from those in addition to required subchapter.’” (quoting Id., at 436 under this (2000 136v(b) ed.)). U. The Bates Court stated: S. C. “Conspicuously by [re- absent the submissions plausible any spondent] and United States is alterna- the interpretation ‘in to or different from’ tive addition they phrase meaning. ap- give Instead, that would reading pear statute, those to favor words out the following: leave State which would ‘Such shall requirements any impose or continue effect label- amputated [the ing packаging.’ This version of stat- succinctly clearly ute] no doubt have com- would pre-emption requirements of all state manded labeling. concerning That added the remain- provision is evidence its intent draw der of requirements labeling between state a distinction pre-empted those are at S., not.” 544 U. are 448-449. statutory rejected by interpretation this Court

As interpretation majority’s function- Bates, key including ally out of the statute, 13 words excises Walker, See Duncan v. 533 S. U. term “unavoidable.” (“We (2001) especially unwilling” statutory are to treat a occupies pivotal surplusage “when the term so term as scheme”). resulting statutory Although place in the statutory provision no “amputated version” “would succinctly clearly pre- commanded the have doubt “[t]hat emption defect claims, state” fact of all

265 provision” strong added the remainder of the is pre-empt of its intent not to evidence defect claims categorically. Bates, S., 449; 544 U. at see also Ameri Corp. v. Ferrari, Home Prods. can Ga. 384, (2008) (“‘If Congress 2d had S. E. intended de parties long prive injured compensa of a available form of surely expressed it tion, would have intent more ” clearly’ 449)), (quoting pending, Bates, S.,U. at cert. 08-1120. No.

Strikingly, majority interpretation the that its concedes entirely superfluous. renders 13 of the statute words (“The (‘the intervening passage injury ante, at 236 or death from side effects that were resulted unavoidable even unnecessary. though’) enough”). True Nevertheless, the majority against giving portion contends that “the rule interpretation superfluous ap- text an which renders ... verbosity plies only prolixity by giv- if can be eliminated offending ing passage, the or the remainder of text, the competing interpretation.” According major- Ibid. to the ity, petitioners’ reading of the renders “even though” superfluous petitioners’ clause because, reach de- say “[i]t injury ‘if outcome, sired would sufficeto the or death stop.” resulted from side effects were unavoidable’—full explained Ante, above, at 237. As however, “even though” prerequisites— two clause establishes additional proper manufacturing proper labeling qualify —to 22(b)(l)’s liability. exemption Contrary major- to the ity’s though” “even contention, then, clause serves an im- portant limiting by scope pre-emption function preceding “if” afforded clause.14 manner, though” In this “even clause functions in a “concessive ante, fashion, 235, in subordinat[ing]” grammatical accord with normal usage. According majority, however, to the though” “even clause ” it” precedes “delineating] “clarifies the word the conditions that Ante, make a “unavoidable” under the side effect statute. at 231. The ma jority’s interpretation hardly “concessive,” treats clause as and indeed majority’s argument only on the based other textual According

expressio unius, canon. exclusio alterius majority, products generally law because blackletter types product “[i]f recognizes all defects, three different strange preserved, were to be it would be three intended Congress] only specifically namely, [for mention to two”— manufacturing though” labeling “even defects in the implication.” Ante, the at 232. clause —“and leave third ignores majority’s argument, that default however, The preserved. under Act is that state law is rule Vaccine 22(a) § explained expressly provides above, As that “[g]eneral apply to a rule” that “State law shall civil action injury brought damages for vaccine-related or death.” 300aa-22(a). 22(a) § § already preserves C. Because U. S. (to design exemption claims state-law defect extent 22(b)(1) apply), § Congress not there was no need for in does expressly preserve design separately and defect claims 22(b)(1). enacting § Congress’ principal in Indeed, aim 22(b)(1) § preserve manufacturing labeling was not §22(a)), (those, preserved by already were too, but claims A;-typeprotection for federalize comment “unavoid- rather, to though” simply ably vaccines. The “even clause unsafe” applicability to limit the of that The defense. functions 22(b)(1) § language specifically preserv- express lack of fairly design ing claims cannot as defect thus be understood (and categorically) pre-empting impliedly such traditional majority’s view, proper meaning though.” of “even In the strains labeling are that prerequisites the sole render vac- manufacturing Thus, injurious effect is unavoid- unavoidable. side effects cine’s side prepared properly labeled, was not “even the vaccine able because conjunctions two are not equivalent: The The sentence it was. though” though it raining” hardly can read to even mean happy “I am any event, In because raining.” it is the more fundamental happy “I am interpretation gives to the actually meaning petitioners’ point is that majority interpreta- whereas that its though,” concedes “even words supra entirely those words out of statute. effectively reads tion page. this claims, which been tort had already preserved by

state 22(a).15 § if also suggests Congress wished majority pre defect could have claims, provided simply

serve would manufacturers be liable “defective manufac defective directions and defective ture, warning, design.” Ante, at 233 (internal omitted). marks quotation Putting 22(a) already the fact defect preserves design aside (to the extent does apply), claims majority’s would fully solution not have effectuated Congress’ proposed history clear, As the makes legislative intent. the term effectuate its intent “unavoidable” to that the

used K regarding 'unavoidably Comment unsafe’ “principle to the covered in ... vaccines the bill.” 1986 apply products At see also 691. the time 26; Report Report at Act’s enactment in least one 1986, State ex had Vaccine comment while k,16 others had rejected many not ad- pressly 15 Court, moreover, long operated assumption has on “the This that the are not to be police powers superseded by States historic Fed was the purpose that clear and manifest of Congress.” Act unless eral Good, (2008) (internal Group, 70, Inc. v. 77 quotation 555 U. S. Altria omitted). long history regulation of alteration Given state marks vaccines, 3-6, for presumption provides Brief Petitioners see an of pre-empting to read as design reason not all defect additional Congress’ of an claims, especially given express saving inclusion clause in section, statutory 300aa-22(a), see C. 42 U. S. and its use of same in defining pre-emptive scope the provision. “if” clause conditional LLC, (2005) (“In Agrosciences 431, Bates v. Dow U. 544 S. 449 areas regulation, that a we assume federal traditional state statute has not state law unless has made such intention supplanted clear omitted)). (internal quotation manifest” marks Co., 166, Lilly v. Eli 197, 2d See Collins 37, 342 N. W. Wis. 2d (“We that in is (1984) conclude the rule comment k too embodied restric and, therefore, products liability with strict commensurate law tive Wisconsin”). did, “recognize Collins however, exigent that some neeessary place drug may it on the market before circumstances Ibid. testing adopted It thus adequate can be done.” a narrower de circumstances”) (based “exigent than that recognized on in other fense comment k. expressly adopted had jurisdictions specifically applicability to vac- of comment k dressed applied proceeding on a k to civil actions or cines comment (e. g., theory negligence17). A stat- than other strict simply manufacturers would be ute vaccine stated design” would be silent as the avail- liable for “defective “unavoidably ability fe-type defense unsafe” of comment fully Congress’ not have achieved vaccines, thus would liability protection extending greater aim man- k-type protection providing in all ufacturers comment civil actions as federal law. a matter

B majority’s arguments no than The structural fare better principal majority’s posi- its textual thrust of the ones. nothing in that, tion is since the Vaccine Act the FDA's expressly regulations governing design vaccines mentions Congress must intended to remove con- have issues defects, cerning design of FDA-licensed vaccines from the tort reasoning, system. Ante, course, at 237. The flaw that long is FDA’s defects that the silence existed be- majority Indeed, fore Act was еnacted. it- the Vaccine spelled that the “FDA even out in has never self concedes regulations it the criteria uses to decide whether a vaccine yet its intended Ibid. And effective use.”18 safe and prior undisputed Act, to the vaccine manufacturers Kearl, 465, g., 3d, e. Cal. at App. Rptr., n. 218 Cal. See, merely unavoidably dangerous (“[T)he product exempts doctrine n. 15 liability analysis; plaintiff a design a strict defect remains product Toner, design theory negligence”); defect on the his basis pursue free to (“The 2d, 340, 732 universally at agree P. 309-310 authorities Idaho, at unavoidably unsafe, plaintiff is deemed is de product a where liability action, may of a strict advantage pro cause but prived of the action”). negligence cause of ceed a under §262(a)(2)(C)(i)(I) (“The Secretary approve C. shall bio- S. See 42 U. ... on of a . . . application the basis demonstration that logies license subject application safe, pure, is the product biological potent”). and subject long been to state

had under tort law for design. vaccine That the Vaccine Act did defective not itself comprehensive regulatory respect forth scheme with set design defects is thus best understood to mean not to suddenly Congress change decided course sub silentio and longstanding, category pre-empt a traditional of state tort rather, that law, but intended leave the status (except, respect quo aspects of course, alone with to those altered). expressly law that the tort Act state Re- (“It port preclude is not the Committee’s intention to applicable actions under law. court The Committee’s intent considering the time of the Act . . . was ... to leave applicable except expressly law unaffected, otherwise as al- Act”). by the tered majority suggests Congress necessarily also in pre-empt design

tended defect claims since the aim of such promote development improved is to designs tort suits provide compensation injured individuals, and the “provides achieving Aсt other Vaccine means both ef notably through compensation pro fects”—most the no-fault gram Program. National Vaccine Ante, at 238-239, §§ (citing 300aa-2(a)(1)-(3), 57-60 and nn. U. 300aa-l, S. C. 300aa-27(a)(1)). 300aa-25(b), majority’s 300aa-3, But the position significant elides a difference between state tort law regulatory Although federal and the scheme. the Vaccine charges Secretary Act of Health and Human Services obligation “promote development with the of childhood .,. improvements vaccines” “make or assure vaccines, §300aa-27(a), vaccines,” and research on neither the Act nor any provision places duty legal other of federal law on vac improve manufacturers to cine of their vaccines technological to account for scientific advances. Indeed, approval does being the FDA not condition aof optimally designed among reasonably the most available al (or any entity) nor does it ternatives, other federal ensure keep pace technological that licensed vaccines and sci- 270 the of Rather, ensuring

entific advances.19 function are of existing vaccines science optimally designed light the to technology left traditionally has been States the of for defects. through imposition design damages Bates, 544 U. (“ 451 of actions S., damage Cf. ‘[T]he specter manufacturers with dynamic added incentives may provide of all injuries to to possible stemming continue abreast keep of use their so as such to forestall actions product[s] 19 (CA5 1988) Labs., See, Hurley 1173, e.g., 2d 1177 v. Lederle F. (“[T]he passive approve a it to agency: FDA is considers whether vaccine a only proposal”); if designs and when manufacturers come forward (EDNY 1988) (“[T]he Labs., Supp. F. agency v. Lederle Jones goal drugs and its to the manufacturers as them. While takes finds possible vaccine, inoculation with the best it is limited to oversee review manufacturers, regardless only drugs various of ing those submitted flaws”). existing regulations authority the FDA has Although under their authority biologies licenses, can manufaсturer’s be exer to revoke (as here) product only “[t]he licensed is not safe and where relevant cised §601.5(b)(1)(vi) (2010); its of uses.” CFR effective for all intended see (defining “safety” as “relative from harmful 600.3(p) freedom effect to affected, directly indirectly, product prudently persons when ad ministered, taking product of into consideration character in rela time”). at the recipient regulation condition does tion a biologies FDA to revoke license a manufacturer’s not authorize optimal design existing vaccine of adopt light science and failure to Conk, Design There a in the Is Defect Restatement technology. See Liability? (Third) J. Products Yale L. Torts: 1128-1129 of (“The (1999-2000) products optimal does not claim review design.... FDA . drug . . asks less manufacturers than common review thus FDA manufacturers”). asks other At oral products kinds law of for amicus United that the States stated Centers for argument, counsel (CDC) routinely performs comparative and Prevention Control Disease already Arg. that are Tr. of Oral analyses market. See of vaccines (describing comparison CDC’s 44-45; id., polio Sabin Salk at 52-53 vaccines). however, nor any parties, States United has Neither examines whether a CDC safer alternative vaccine could represented that given practical limits, inquiry central designed scientific have been action for defect. CDC issue biologies does not in a tort law state moreover, has no authority require and thus licenses, manufacturer design. adopt a different v. Levine, improvement’”); Wyeth product 555 U. through S. (2009) 578-579 that the FDA has (noting “traditionally a state law as form of regarded complementary drug regula as tort suits uncover tion” unknown “[s]tate hazards drug and incentives manufacturers to provide drug disclose The risks of the safety importance promptly”).20 States’ role is regulatory only traditional underscored by unique market, features vaccine which there are one “only for a majority or two manufacturers of vaccines listed the routine immunization childhood schedule.” Brief for 55. The normal forces that Respondent competitive in spur to and novation improvements existing product lines other thus less force in the operate markets vaccine market, already for vaccines that have been released particularly and to marketed Absent a clear public. statutory mandate is no contrary, to the there reason to think that Congress in the context intended eliminate the traditional incentive and deterrence functions served state tort lia in favor of a federal bility scheme regulatory providing only Levine, and (“The carrots no sticks.21 See U. S., at 575 20Indeed, we observed in Levine that the FDA perpetually under underfunded, S., at 578, staffed and see 555 U. agency n. and the has past response criticized in the for its slow in failing been to withdraw g., potentially dangerous products, see, e. Leveton, or warn about L. Sox, Stoto, Medicine, & M. of H. Institute HIV Supply: Blood (1995) Analysis Decisionmaking (criticizing An Crisis response FDA through supply). practical AIDS blood transmission These shortcom reinforce the ings conclusion “state law offers an additional, im layer portant, protection complements of consumer regulation.” FDA Levine, S., 555 U. at 579. majority my position mischaraeterizes expressing general as a congressional unless “skeptictism] pre-emption operate[s] substitute Ante, system.” Congress could, the tort at 240. course, like a adopt regime operates differently regulatory from state tort systems, and necessarily question Congress’ difference is not reason to pre such intent. emptive specific Act, In the context of the however, Vaccine point is that should not lightly this Court assume Congress relevant sub silentio longstanding displace species intended state tort liabil- pre-emption particularly for federal where Con- case weak operation gress has its awareness of of state indicated law in a field of interest, federal has nonetheless decided concepts to stand both tolerate tension whatever (internal quotation there is between them” alter- marks and omitted)). ation

Ill enacting In Act, the Vaccine established a care- fully wrought competing federal scheme that balances vaccine-injured persons interests of and vaccine manufactur- legislative history As the indicates, ers. the Act addressed “(a) overriding inadequacy “two concerns”: both —from vaccine-injured perspective persons of the as vaccine well as approach compensating manufacturers —of the current (b) damaged by a vaccine; those who have been the insta- bility unpredictability the of childhood vaccine market.” Report 7. When viewed in the context of the Vaccine just part is whole, Act as a one of a stat- broader utory compensating the that for balances need scheme liability protections vaccine-injured children with added for to ensure a stable childhood vaccine vaccine manufacturers market. principal of the the innovation Act was creation of the

The entirely program compensation scheme funded no-fault —a Through program, through vaccines.22 tax on that excise an Congress here, specifically express saving an clause where, included ity as law, long history regulation there is a of state-law preserving state important pre-emption of state law would leave design, vaccine e., entirely ensuring optimal vaccine unad- regulatory function —i. — congressional substitute. by the dressed suggestion that from their “vaccine manufacturers fund majority’s The Ante, program misleading. Although 239. compensation sales” tax, pay specifi amount of the nominally tax is the manufacturers price charged purchasers. CDC Vac cally the vaccine See included (Feb. 15, 2011), http://www.cdc.gov/vaccines/programs/vfc/ cine Price List way Accordingly, only manufactur vaccine cdc-vac-price-list.htm. compensation program if the cost actually “fund” the can said to ers relieved vaccine manufacturers burden victims of vaccine-related compensating injuries the vast of cаses23—an extremely majority significant economic bene- “functionally fit valuable creat[es] insurance policy for vaccine-related Brief for injuries.” Reply Petitioners structure and legislative history, moreover, point 10.. intention to divert clearly Congress’ would-be tort claim- into the ants rather compensation than program, eliminate a of traditional tort category claims. longstanding See 1986 (“The Committee Report anticipates speed the low compensation program, transaction costs of the sys- tem, the no-fault nature of the required findings, and the certainty relative generosity system’s awards will number of significant divert potential plaintiffs from liti- Indeed, gation”). although complete pre-emption tort have claims would eliminated source principal of the “un- in the market, predictability” Congress specifically chose not state tort claims pre-empt categorically. 300aa-22(a) S. C. as a U. (providing rule” “[gjeneral law to a “State shall civil action apply brought damages death”). a vaccine-related injury That decision re- flects Congress’ court actions recognition are essential because they provide injured persons with significant proce- dural most civil including, importantly, discovery— tools — that are available administrative under proceedings compensation program. (d)(3). §§300aa-12(d)(2)(E), impact of the excise tax has an on the number of vaccines sold majority points vaccine manufacturer. The to no evidence that the excise ordinarily dose, 4131(b)— per tax —which amounts to 75 cents 26 U. S. C. any impact has whatsoever on the demand for vaccines. 23See Brief for United States as Amicus Curiae (“Department of Justice records indicate that of Compensation 99.8% successful Program accepted awards, forgoing any claimants have their against tort remedies manufacturers”); Plotkin, Orenstein, vaccine S. Offit, W. & P. Vaccines 1673 (5th 2008) “[virtually (noting petitioners, ed. that all .. . even those who compensation” compensation were not under the program, awarded choose determination). accept program's to important clearly Congress there still thus was believed played by to tort function state law. entirely, liability eliminating design of

Instead defect Con- gress to enacted measures reduce manufacturers’ numerous compliance liability exposure, including regulatory a limited warnings, §300aa-22(b)(2), presumption adequate of see provide direct of on failure to elimination claimsbased warn- §300aa-22(e), heightened pu- ings patients, a standard for §300aa-23(d)(2), immunity damages, and, course, of nitive §300aa- damages effects, for “unavoidable” side 22(b)(1). light Act as a whole, Considered Vaccine §22(b)(l)’s unavoidably exemption from unsafe just statutory part one a broader scheme vaccines is Congress’ providing between ade- careful balance reflects vaccine-injured compensation quate children and confer- ring substantial benefits on vaccine manufacturers ensure supply. predictable childhood vaccine a stable today majority’s careful decision disturbs balance policy preference that it “to on a bare is better leave based epidemiological judgments design complex about vaccine Program ju- Vaccine rather than FDA and National Ante, at sure, 239.24 To be minds can reasonable dis- ries.” juries weigh having agree the wisdom relative about particular design. of a vaccine But what- benefits costs and policy majority’s preference, ofthe the deci- ever the merits design against vaccine defect claims all manufac- sion to bar By this make, must Court.25 one turers is Breyer's separate explicitly policy concurrence is even more Justice preference expert judgment” for the his own “more reflecting driven, Ante, judgment juries. expert” the “less over 247. agencies federal 5,000 petitions alleging there are some notes that causal Respondent spectrum autism vaeeines and disorders are cur certain between link proceeding in omnibus the Court Federal Claims in an rently pending (Vaccine Court). Respondent According respondent, 56-57. Brief for pre-empt claims does not defect could un ruling that bankrupt litigation of tort vaccine wave” that would “crushing leash Id., deplete supply. at 28. This concern un- manufacturers to all construing pre-empt design defect claims vaccine manufacturers for covered vaccines, the ma- against decision leaves a regulatory vacuum in which jority’s no the FDA nor other any one —neither federal nor agency, federal and that vaccine juries state manufacturers —ensures take account of scientific and adequately ad- technological This concern is vancements. acute especially with respect that have been already to vaccines released and marketed to many policy arguments respondent’s in derlies brief appears and majority concurring opinions the in underlie this case. In the absence data, any empirical however, prospect the onslaught of autism- litigation by tort claimants related denied relief the Vaccine Court wholly speculative. matter, As an Special initial seems the Masters in the uniformly rejected have alleged autism cases thus far causal link be- vaccines and Academy tween autism. Brief for American of Pediat- cases). al. as Amici 20-21, Curiae (collecting n. 4 sure, rics et To be those necessarily not rulings do mean that no exists, such causal link cf. Brief Amicus Curiae (noting United States injuries for as have been Injury existing vaccines), to the Vaccine Table for added or that claimants ultimately prove able such a link in a action, will state tort discovery. tool civil particularly the added But these rulings do highlight recovery the substantial hurdles to a claimant faces. See Co., (CA1 Cyanamid American 1994) v. (“[A] F. 3d peti- Schafer gives whom the Court nothing may point tioner to Vaccine see no trying in yet tort law’s recovery”). to overcome more serious obstacles to Trial moreover, courts, have experience efficiently considerable handling and products claims, disposing of meritless litiga- decades of tort defect) (including prescription-drug tion context have not shortages drugs. in prescription Despite doomsday predictions led respondent and the various amici concurrence, ante, cited 248-249, possibility torrent of meritless lawsuits bankrupting causing shortages manufacturers seems remote at best. fundamentally, policy arguments, More whatever merits of these decided, Congress this case is what has question, issue and as to that text, structure, history compel legislative the conclusion that Con- open intended to gress leave the doors courthouse children who have injuries defectively severe designed suffered major- vaccines. The ity’s policy-driven contrary usurps Congress’ decision role and de- vaccine-injured remedy prives key such children of a in- them to have. tended given competi- public. the lack Manufacturers, ‍​​​‌​​‌‌​‌‌​‌​​​​‌​​‌​​​‌​‌‌​​‌​​‌‌‌​​​‌‌‌​​‌​​​‍of robust in the in-

tion will often have little or no market, improve designs already centive to vaccines are margins. Nothing generating significant profit text, in the legislative history remotely suggests structure, or that Con- gress intended that result. respectfully

I dissent. notes administrative It safety says review. rigorous survived the Act as permitting design-defect lawsuits could read of “exactly crisis that precipitated recurrence lead of withdrawals vaccines or vaccine manu- Act,” namely, market, the Act’s “disserv[ing] central facturers ability hampering agency’s “expert purposes,” with the medical conjunction community, [to] regulators, availability and withdrawal a given vaccine.” control Amicus Curiae as 31. States for United Brief in this claim by supported States leading United the American including Academy health organizations, public Physicians, American Academy Family Pediatrics, Medicine, the College of Preventive American American Association, the American Medical Associa- Health Public Foundation, Dimes Pediatric Infec- tion, the March other similar Society, organizations. Diseases tious Pediatrics et al. as Amici Academy for American Brief

Case Details

Case Name: Bruesewitz v. Wyeth LLC

Court Name: Supreme Court of the United States

Date Published: Feb 22, 2011

Citation: 562 U.S. 223

Docket Number: 09-152

Court Abbreviation: SCOTUS