(Slip Opinion) OCTOBER TERM, 2010 1 

Syllabus 

NOTE: Where it is feasible, a syllabus (headnote) will be released, as is

being done in connection with this case, at the time the opinion is issued.

The syllabus constitutes no part of the opinion of the Court but has been

prepared by the Reporter of Decisions for the convenience of the reader. 

See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337. 

SUPREME COURT OF THE UNITED STATES 

Syllabus 

BRUESEWITZ ET AL. v. WYETH LLC, FKA WYETH, INC., 

ET AL. 

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR 

THE THIRD CIRCUIT 

No. 09–152. Argued October 12, 2010—Decided February 22, 2011 

The National Childhood Vaccine Injury Act of 1986 (NCVIA or Act) created a no-fault compensation program to stabilize a vaccine market 

adversely affected by an increase in vaccine-related tort litigation

and to facilitate compensation to claimants who found pursuing legitimate vaccine-inflicted injuries too costly and difficult. The Act 

provides that a party alleging a vaccine-related injury may file a petition for compensation in the Court of Federal Claims, naming the 

Health and Human Services Secretary as the respondent; that the 

court must resolve the case by a specified deadline; and that the

claimant can then decide whether to accept the court’s judgment or 

reject it and seek tort relief from the vaccine manufacturer. Awards 

are paid out of a fund created by an excise tax on each vaccine dose. 

As a quid pro quo, manufacturers enjoy significant tort-liability protections. Most importantly, the Act eliminates manufacturer liability

for a vaccine’s unavoidable, adverse side effects. 

Hannah Bruesewitz’s parents filed a vaccine-injury petition in the 

Court of Federal Claims, claiming that Hannah became disabled after receiving a diphtheria, tetanus, and pertussis (DTP) vaccine

manufactured by Lederle Laboratories (now owned by respondent 

Wyeth). After that court denied their claim, they elected to reject the 

unfavorable judgment and filed suit in Pennsylvania state court, alleging, inter alia, that the defective design of Lederle’s DTP vaccine 

caused Hannah’s disabilities, and that Lederle was subject to strict

liability and liability for negligent design under Pennsylvania common law. Wyeth removed the suit to the Federal District Court. It 

granted Wyeth summary judgment, holding that the relevant Pennsylvania law was preempted by 42 U. S. C. §300aa–22(b)(1), which 
2 BRUESEWITZ v. WYETH LLC 

Syllabus 

provides that “[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if 

the injury or death resulted from side-effects that were unavoidable 

even though the vaccine was properly prepared and was accompanied

by proper directions and warnings.” The Third Circuit affirmed. 

Held: The NCVIA preempts all design-defect claims against vaccine 

manufacturers brought by plaintiffs seeking compensation for injury 

or death caused by a vaccine’s side effects. Pp. 7–19.

(a) Section 300aa–22(b)(1)’s text suggests that a vaccine’s design is 

not open to question in a tort action. If a manufacturer could be held 

liable for failure to use a different design, the “even though” clause 

would do no work. A vaccine side effect could always have been 

avoidable by use of a different vaccine not containing the harmful 

element. The language of the provision thus suggests the design is

not subject to question in a tort action. What the statute establishes 

as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design. This conclusion is supported by the fact that, although products-liability law establishes three grounds for liability—defective manufacture, 

inadequate directions or warnings, and defective design—the Act 

mentions only manufacture and warnings. It thus seems that the 

Act’s failure to mention design-defect liability is “by deliberate choice, 

not inadvertence.” Barnhart v. Peabody Coal Co., 537 U. S. 149, 168. 

Pp. 7–8.

(b) Contrary to petitioners’ argument, there is no reason to believe

that §300aa–22(b)(1)’s term “unavoidable” is a term of art incorporating Restatement (Second) of Torts §402A, Comment k, which exempts 

from strict liability rules “unavoidably unsafe products.” “Unavoidable” is hardly a rarely used word, and cases interpreting comment k 

attach special significance only to the term “unavoidably unsafe

products,” not the word “unavoidable” standing alone. Moreover, 

reading the phrase “side effects that were unavoidable” to exempt injuries caused by flawed design would require treating “even though”

as a coordinating conjunction linking independent ideas when it is a 

concessive, subordinating conjunction conveying that one clause 

weakens or qualifies the other. The canon against superfluity does

not undermine this Court’s interpretation because petitioners’ competing interpretation has superfluity problems of its own. Pp. 8–12.

(c) The structure of the NCVIA and of vaccine regulation in general 

reinforces what §300aa–22(b)(1)’s text suggests. Design defects do

not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process. This lack of guidance for design defects, combined with 
Cite as: 562 U. S. ____ (2011) 3 

Syllabus 

the extensive guidance for the two liability grounds specifically mentioned in the Act, strongly suggests that design defects were not mentioned because they are not a basis for liability. The Act’s mandates 

lead to the same conclusion. It provides for federal agency improvement of vaccine design and for federally prescribed compensation,

which are other means for achieving the two beneficial effects of design-defect torts—prompting the development of improved designs, 

and providing compensation for inflicted injuries. The Act’s structural quid pro quo also leads to the same conclusion. The vaccine 

manufacturers fund an informal, efficient compensation program for

vaccine injuries in exchange for avoiding costly tort litigation and the 

occasional disproportionate jury verdict. Taxing their product to fund

the compensation program, while leaving their liability for design defect virtually unaltered, would hardly coax them back into the market. Pp. 13–16. 

561 F. 3d 233, affirmed. 

SCALIA, J., delivered the opinion of the Court, in which ROBERTS, 

C. J., and KENNEDY, THOMAS, BREYER, and ALITO, JJ., joined. BREYER, 

J., filed a concurring opinion. SOTOMAYOR, J., filed a dissenting opinion, 

in which GINSBURG, J., joined. KAGAN, J., took no part in the consideration or decision of the case. 
_________________ 

_________________ 

Cite as: 562 U. S. ____ (2011) 1 

Opinion of the Court 

NOTICE: This opinion is subject to formal revision before publication in the

preliminary print of the United States Reports. Readers are requested to

notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in order

that corrections may be made before the preliminary print goes to press. 

SUPREME COURT OF THE UNITED STATES 

No. 09–152 

RUSSELL BRUESEWITZ, ET AL., PETITIONERS v. 

WYETH LLC, FKA WYETH, INC., FKA WYETH

LABORATORIES, ET AL. 

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE THIRD CIRCUIT

 [February 22, 2011] 

JUSTICE SCALIA delivered the opinion of the Court. 

We consider whether a preemption provision enacted in

the National Childhood Vaccine Injury Act of 1986

(NCVIA)1 bars state-law design-defect claims against

vaccine manufacturers. 

I 

A 

For the last 66 years, vaccines have been subject to the

same federal premarket approval process as prescription 

drugs, and compensation for vaccine-related injuries has

been left largely to the States.2 Under that regime, the 

elimination of communicable diseases through vaccination 

became “one of the greatest achievements” of public health

in the 20th century.3 But in the 1970’s and 1980’s vac-

—————— 

1 42 U. S. C. §300aa–22(b)(1). 2See P. Hutt, R. Merrill, & L. Grossman, Food and Drug Law 912–

913, 1458 (3d ed. 2007). 3Centers for Disease Control, Achievements in Public Health, 1900– 

1999: Impact of Vaccines Universally Recommended for Children, 48 

Morbidity and Mortality Weekly Report 243, 247 (Apr. 2, 1999). 
2 BRUESEWITZ v. WYETH LLC 

Opinion of the Court 

cines became, one might say, victims of their own success.

They had been so effective in preventing infectious diseases that the public became much less alarmed at the 

threat of those diseases,4 and much more concerned with 

the risk of injury from the vaccines themselves.5 

Much of the concern centered around vaccines against 

diphtheria, tetanus, and pertussis (DTP), which were 

blamed for children’s disabilities and developmental delays. This led to a massive increase in vaccine-related tort 

litigation. Whereas between 1978 and 1981 only nine 

product-liability suits were filed against DTP manufacturers, by the mid-1980’s the suits numbered more than 200

each year.6 This destabilized the DTP vaccine market, 

causing two of the three domestic manufacturers to withdraw; and the remaining manufacturer, Lederle Laboratories, estimated that its potential tort liability exceeded its

annual sales by a factor of 200.7 Vaccine shortages arose

when Lederle had production problems in 1984.8 

Despite the large number of suits, there were many

complaints that obtaining compensation for legitimate

vaccine-inflicted injuries was too costly and difficult.9 A 

—————— 

4See Mortimer, Immunization Against Infectious Disease, 200 Science 902, 906 (1978). 5See National Vaccine Advisory Committee, A Comprehensive Review of Federal Vaccine Safety Programs and Public Health Activities

2–3 (Dec. 2008) (hereinafter NVAC), http://www.hhs.gov/nvpo/nvac/

documents/vaccine-safety-review.pdf (as visited Feb. 18, 2011, and 

available in Clerk of Court’s case file). 6See Sing & Willian, Supplying Vaccines: An Overview of the Market

and Regulatory Context, in Supplying Vaccines: An Economic Analysis

of Critical Issues 45, 51–52 (M. Pauly, C. Robinson, S. Sepe, M. Sing, &

M. William eds. 1996). 7See id., at 52. 8See Centers for Disease Control, Diptheria-Tetanus-Pertussis Vaccine Shortage, 33 Morbidity and Mortality Weekly Report 695–696

(Dec. 14, 1984). 9See Apolinsky & Van Detta, Rethinking Liability for Vaccine Injury, 

19 Cornell J. L. & Pub. Pol’y 537, 550–551 (2010); T. Burke, Lawyers, 
Cite as: 562 U. S. ____ (2011) 3 

Opinion of the Court 

significant number of parents were already declining 

vaccination for their children,10 and concerns about compensation threatened to depress vaccination rates even

further.11 This was a source of concern to public health

officials, since vaccines are effective in preventing outbreaks of disease only if a large percentage of the population is vaccinated.12 

To stabilize the vaccine market and facilitate compensation, Congress enacted the NCVIA in 1986. The Act establishes a no-fault compensation program “designed to work 

faster and with greater ease than the civil tort system.” 

Shalala v. Whitecotton, 514 U. S. 268, 269 (1995). A person injured by a vaccine, or his legal guardian, may file a

petition for compensation in the United States Court of 

Federal Claims, naming the Secretary of Health and

Human Services as the respondent.13 A special master

then makes an informal adjudication of the petition within

(except for two limited exceptions) 240 days.14 The Court 

of Federal Claims must review objections to the special 

master’s decision and enter final judgment under a similarly tight statutory deadline.15 At that point, a claimant 

has two options: to accept the court’s judgment and forgo a

traditional tort suit for damages, or to reject the judgment

and seek tort relief from the vaccine manufacturer.16 

Fast, informal adjudication is made possible by the Act’s

Vaccine Injury Table, which lists the vaccines covered 

under the Act; describes each vaccine’s compensable, 

—————— 

Lawsuits, and Legal Rights: The Battle over Litigation in American 

Society 146 (2002). 10Mortimer, supra, at 906. 11See Hagan, 45 Food Drug Cosm. L. J. 477, 479 (1990). 12See R. Merrill, Introduction to Epidemiology 65–68 (2010). 13See 42 U. S. C. §300aa–11(a)(1). 14See §300aa–12(d)(3). 15See §300aa–12(e), (g). 16See §300aa–21(a). 
4 BRUESEWITZ v. WYETH LLC 

Opinion of the Court 

adverse side effects; and indicates how soon after vaccination those side effects should first manifest themselves.17 

Claimants who show that a listed injury first manifested

itself at the appropriate time are prima facie entitled to

compensation.18 No showing of causation is necessary; the

Secretary bears the burden of disproving causation.19 A 

claimant may also recover for unlisted side effects, and for

listed side effects that occur at times other than those 

specified in the Table, but for those the claimant must 

prove causation.20 Unlike in tort suits, claimants under 

the Act are not required to show that the administered 

vaccine was defectively manufactured, labeled, or designed.

Successful claimants receive compensation for medical, 

rehabilitation, counseling, special education, and vocational training expenses; diminished earning capacity;

pain and suffering; and $250,000 for vaccine-related 

deaths.21 Attorney’s fees are provided, not only for successful cases, but even for unsuccessful claims that are not 

frivolous.22 These awards are paid out of a fund created by

an excise tax on each vaccine dose.23

 The quid pro quo for this, designed to stabilize the

vaccine market, was the provision of significant tortliability protections for vaccine manufacturers. The Act 

requires claimants to seek relief through the compensation 

program before filing suit for more than $1,000.24 Manufacturers are generally immunized from liability for fail-

—————— 

17See §300aa–14(a); 42 CFR §100.3 (2009) (current Vaccine Injury 

Table). 18See 42 U. S. C. §§300aa–11(c)(1), 300aa–13(a)(1)(A). 19See §300aa–13(a)(1)(B). 20See §300aa–11(c)(1)(C)(ii). 21See §300aa–15(a). 22See §300aa–15(e). 23See §300aa–15(i)(2); 26 U. S. C. §§4131, 9510. 24See 42 U. S. C. §300aa–11(a)(2). 
Cite as: 562 U. S. ____ (2011) 5 

Opinion of the Court 

ure to warn if they have complied with all regulatory

requirements (including but not limited to warning requirements) and have given the warning either to the 

claimant or the claimant’s physician.25 They are immunized from liability for punitive damages absent failure to 

comply with regulatory requirements, “fraud,” “intentional 

and wrongful withholding of information,” or other “criminal or illegal activity.”26 And most relevant to the present

case, the Act expressly eliminates liability for a vaccine’s 

unavoidable, adverse side effects: 

“No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury

or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even 

though the vaccine was properly prepared and was accompanied by proper directions and warnings.”27 

B 

The vaccine at issue here is a DTP vaccine manufactured by Lederle Laboratories. It first received federal 

approval in 1948 and received supplemental approvals in

1953 and 1970. Respondent Wyeth purchased Lederle in

1994 and stopped manufacturing the vaccine in 1998. 

Hannah Bruesewitz was born on October 20, 1991. Her 

pediatrician administered doses of the DTP vaccine according to the Center for Disease Control’s recommended

childhood immunization schedule. Within 24 hours of her 

April 1992 vaccination, Hannah started to experience 

—————— 

25See §300aa–22(b)(2), (c). The immunity does not apply if the plaintiff establishes by clear and convincing evidence that the manufacturer

was negligent, or was guilty of fraud, intentional and wrongful withholding of information, or other unlawful activity. See §§300aa– 

22(b)(2), 300aa–23(d)(2). 26 §300aa–23(d)(2). 27 §300aa–22(b)(1). 
6 BRUESEWITZ v. WYETH LLC 

Opinion of the Court 

seizures.28 She suffered over 100 seizures during the next 

month, and her doctors eventually diagnosed her with

“residual seizure disorder” and “developmental delay.”29 

Hannah, now a teenager, is still diagnosed with both

conditions. 

In April 1995, Hannah’s parents, Russell and Robalee 

Bruesewitz, filed a vaccine injury petition in the United 

States Court of Federal Claims, alleging that Hannah

suffered from on-Table residual seizure disorder and 

encephalopathy injuries.30 A Special Master denied their

claims on various grounds, though they were awarded

$126,800 in attorney’s fees and costs. The Bruesewitzes 

elected to reject the unfavorable judgment, and in October 

2005 filed this lawsuit in Pennsylvania state court. Their 

complaint alleged (as relevant here) that defective design 

of Lederle’s DTP vaccine caused Hannah’s disabilities, and 

that Lederle was subject to strict liability, and liability for 

negligent design, under Pennsylvania common law.31 

Wyeth removed the suit to the United States District

Court for the Eastern District of Pennsylvania, which

granted Wyeth summary judgment on the strict-liability 

and negligence design-defect claims, holding that the 

Pennsylvania law providing those causes of action was

preempted by 42 U. S. C. §300aa–22(b)(1).32 The United 

States Court of Appeals for the Third Circuit affirmed.33 

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

—————— 

28See Bruesewitz v. Secretary of Health and Human Servs., No. 95– 

0266V, 2002 WL 31965744, *3 (Ct. Cl., Dec. 20, 2002). 29 561 F. 3d 233, 236 (CA3 2009). 30See id., at *1. 31See 561 F. 3d at 237. The complaint also made claims based upon

failure to warn and defective manufacture. These are no longer at

issue. 

32See id., at 237–238. 33 Id., at 235. 
Cite as: 562 U. S. ____ (2011) 7 

Opinion of the Court 

II 

A 

We set forth again the statutory text at issue: 

“No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury

or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even 

though the vaccine was properly prepared and was accompanied by proper directions and warnings.”34 

The “even though” clause clarifies the word that precedes

it. It delineates the preventative measures that a vaccine 

manufacturer must have taken for a side-effect to be considered “unavoidable” under the statute. Provided that 

there was proper manufacture and warning, any remaining side effects, including those resulting from design

defects, are deemed to have been unavoidable. State-law 

design-defect claims are therefore preempted. 

If a manufacturer could be held liable for failure to use a 

different design, the word “unavoidable” would do no 

work. A side effect of a vaccine could always have been 

avoidable by use of a differently designed vaccine not 

containing the harmful element. The language of the

provision thus suggests that the design of the vaccine is a 

given, not subject to question in the tort action. What the 

statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with 

respect to the particular design. Which plainly implies

that the design itself is not open to question.35 

—————— 

34 42 U. S. C. §300aa–22(b)(1). 35The dissent advocates for another possibility: “[A] side effect is 

‘unavoidable’ . . . where there is no feasible alternative design that 

would eliminate the side effect of the vaccine without compromising its 

cost and utility.” Post, at 15 (opinion of SOTOMAYOR, J.). The dissent 

makes no effort to ground that position in the text of §300aa–22(b)(1). 
8 BRUESEWITZ v. WYETH LLC 

Opinion of the Court 

A further textual indication leads to the same conclusion. Products-liability law establishes a classic and well

known triumvirate of grounds for liability: defective

manufacture, inadequate directions or warnings, and 

defective design.36 If all three were intended to be preserved, it would be strange to mention specifically only 

two, and leave the third to implication. It would have 

been much easier (and much more natural) to provide that

manufacturers would be liable for “defective manufacture, 

defective directions or warning, and defective design.” It 

seems that the statute fails to mention design-defect 

liability “by deliberate choice, not inadvertence.” Barnhart v. Peabody Coal Co., 537 U. S. 149, 168 (2003). Expressio unius, exclusio alterius. 

B 

The dissent’s principal textual argument is mistaken.

We agree with its premise that “‘side effects that were 

unavoidable’ must refer to side effects caused by a vaccine’s design.”37 We do not comprehend, however, the 

second step of its reasoning, which is that the use of

the conditional term “if” in the introductory phrase “if the 

injury or death resulted from side effects that were unavoidable” “plainly implies that some side effects stemming from a vaccine’s design are ‘unavoidable,’ while 

—————— 

We doubt that Congress would introduce such an amorphous test by

implication when it otherwise micromanages vaccine manufacturers. 

See infra, at 13–14. We have no idea how much more expensive an

alternative design can be before it “compromis[es]” a vaccine’s cost or 

how much efficacy an alternative design can sacrifice to improve safety. 

Neither does the dissent. And neither will the judges who must rule on

motions to dismiss, motions for summary judgment, and motions for 

judgment as a matter of law. Which means that the test would probably have no real-world effect. 36W. Keeton, D. Dobbs, R. Keeton, & D. Owen, Prosser and Keeton on 

Law of Torts 695 (5th ed. 1984); Restatement (Third) of Torts §2 (1999). 37 Post, at 3. 
Cite as: 562 U. S. ____ (2011) 9 

Opinion of the Court 

others are avoidable.”38 That is not so. The “if” clause 

makes total sense whether the design to which “unavoidable” refers is (as the dissent believes) any feasible design

(making the side effects of the design used for the vaccine 

at issue avoidable), or (as we believe) the particular design 

used for the vaccine at issue (making its side effects unavoidable). Under the latter view, the condition established by the “if” clause is that the vaccine have been

properly labeled and manufactured; and under the former,

that it have been properly designed, labeled, and manufactured. Neither view renders the “if” clause a nullity. 

Which of the two variants must be preferred is addressed 

by our textual analysis, and is in no way determined by 

the “if” clause. 

Petitioners’ and the dissent’s textual argument also

rests upon the proposition that the word “unavoidable” in

§300aa–22(b)(1) is a term of art that incorporates comment k to Restatement (Second) of Torts §402A (1963– 

1964).39 The Restatement generally holds a manufacturer 

strictly liable for harm to person or property caused by

“any product in a defective condition unreasonably dangerous to the user.”40 Comment k exempts from this

strict-liability rule “unavoidably unsafe products.” An 

unavoidably unsafe product is defined by a hodge-podge of

criteria and a few examples, such as the Pasteur rabies 

vaccine and experimental pharmaceuticals. Despite this

lack of clarity, petitioners seize upon one phrase in the 

comment k analysis, and assert that by 1986 a majority of 

courts had made this a sine qua non requirement for an

“unavoidably unsafe product”: a case-specific showing that

the product was “quite incapable of being made safer for 

—————— 

38 Ibid. 

39See Brief for Petitioners 29. 40Restatement §402A, p. 347. 
10 BRUESEWITZ v. WYETH LLC 

Opinion of the Court 

[its] intended . . . use.”41 

We have no need to consider the finer points of comment 

k. Whatever consistent judicial gloss that comment may 

have been given in 1986, there is no reason to believe that 

§300aa–22(b)(1) was invoking it. The comment creates a 

special category of “unavoidably unsafe products,” while 

the statute refers to “side effects that were unavoidable.” 

That the latter uses the adjective “unavoidable” and the

former the adverb “unavoidably” does not establish that 

Congress had comment k in mind. “Unavoidable” is 

hardly a rarely used word. Even the cases petitioners cite 

as putting a definitive gloss on comment k use the precise 

phrase “unavoidably unsafe product”;42 none attaches 

special significance to the term “unavoidable” standing 

alone. 

The textual problems with petitioners’ interpretation do 

—————— 

41 Id., Comment k, p. 353; Petitioners cite, inter alia, Kearl v. Lederle 

Labs., 172 Cal. App. 3d 812, 828–830, 218 Cal. Rptr. 453, 463–464 

(1985); Belle Bonfils Memorial Blood Bank v. Hansen, 665 P. 2d 118, 

122 (Colo. 1983). 

Though it is not pertinent to our analysis, we point out that a large

number of courts disagreed with that reading of comment k, and took it 

to say that manufacturers did not face strict liability for side effects of

properly manufactured prescription drugs that were accompanied by

adequate warnings. See, e.g., Brown v. Superior Court, 227 Cal. Rptr.

768, 772–775 (Cal. App. 1986), (officially depublished), aff’d 44 Cal. 3d

1049, 751 P. 2d 470 (1988); McKee v. Moore, 648 P. 2d 21, 23 (Okla. 

1982); Stone v. Smith, Kline & French Labs., 447 So. 2d 1301, 1303– 

1304 (Ala. 1984); Lindsay v. Ortho Pharm. Corp., 637 F. 2d 87, 90–91 

(CA2 1980) (applying N. Y. law); Wolfgruber v. Upjohn Co., 72 App. Div. 

2d 59, 61, 423 N. Y. S. 2d 95, 96 (1979); Chambers v. G. D. Searle & Co., 

441 F. Supp. 377, 380–381 (D Md. 1975); Basko v. Sterling Drug, Inc., 

416 F. 2d 417, 425 (CA2 1969) (applying Conn. law). 42See, e.g., Johnson v. American Cyanamid Co., 239 Kan. 279, 285, 

718 P. 2d 1318, 1323 (1986); Feldman v. Lederle Labs., 97 N. J. 429, 

440, 446–447, 479 A. 2d 374, 380, 383–384 (1984); Belle Bonfils Memorial Blood Bank supra, at 121–123; Cassisi v. Maytag Co., 396 So. 2d 

1140, 1144, n. 4, 1146 (Fla. App. 1981); Racer v. Utterman, 629 S. W. 2d 

387, 393 (Mo. App. 1981). 
Cite as: 562 U. S. ____ (2011) 11 

Opinion of the Court 

not end there. The phrase “even though” in the clause

“even though the vaccine was properly prepared and 

[labeled]” is meant to signal the unexpected: unavoidable 

side effects persist despite best manufacturing and labeling practices.43 But petitioners’ reading eliminates any

opposition between the “even though” clause—called a 

concessive subordinate clause by grammarians—and the

word “unavoidable.”44 Their reading makes preemption 

turn equally on unavoidability, proper preparation, and 

proper labeling. Thus, the dissent twice refers to the 

requirements of proper preparation and proper labeling as

“two additional prerequisites” for preemption independent 

of unavoidability.45 The primary textual justification for 

the dissent’s position depends on that independence.46 

But linking independent ideas is the job of a coordinating 

junction like “and,” not a subordinating junction like “even

though.”47 

—————— 

43The dissent’s assertion that we treat “even though” as a synonym

for “because” misses the subtle distinction between “because” and 

“despite.” See post, at 17, n. 14. “Even though” is a close cousin of the

latter. See Webster’s New International Dictionary 709, 2631 (2d ed. 

1957). The statement “the car accident was unavoidable despite his

quick reflexes” indicates that quick reflexes could not avoid the accident, and leaves open two unstated possibilities: (1) that other, unstated means of avoiding the accident besides quick reflexes existed,

but came up short as well; or (2) that quick reflexes were the only 

possible way to avoid the accident. Our interpretation of §300aa– 

22(b)(1) explains why we think Congress meant the latter in this 

context. (Incidentally, the statement “the car accident was unavoidable 

because of his quick reflexes” makes no sense.) 44See W. Follett, Modern American Usage: A Guide 61 (1966). 45 Post, at 9, 17. 46 Post, at 3–5. 47The dissent responds that these “additional prerequisites” act “in a 

concessive, subordinating fashion,” post, at 17, n. 14 (internal quotation 

marks and brackets omitted). But that is no more true of the dissent’s 

conjunctive interpretation of the present text than it is of all provisions

that set forth additional requirements—meaning that we could eliminate “even though” from our English lexicon, its function being entirely 
12 BRUESEWITZ v. WYETH LLC 

Opinion of the Court 

Petitioners and the dissent contend that the interpretation we propose would render part of §300aa–22(b)(1)

superfluous: Congress could have more tersely and more 

clearly preempted design-defect claims by barring liability 

“if . . . the vaccine was properly prepared and was accompanied by proper directions and warnings.” The intervening passage (“the injury or death resulted from side effects 

that were unavoidable even though”) is unnecessary. True 

enough. But the rule against giving a portion of text an

interpretation which renders it superfluous does not prescribe that a passage which could have been more terse 

does not mean what it says. The rule applies only if verbosity and prolixity can be eliminated by giving the offending passage, or the remainder of the text, a competing

interpretation. That is not the case here.48 To be sure, 

petitioners’ and the dissent’s interpretation gives independent meaning to the intervening passage (the supposed

meaning of comment k); but it does so only at the expense 

of rendering the remainder of the provision superfluous. 

Since a vaccine is not “quite incapable of being made safer 

for [its] intended use” if manufacturing defects could have 

been eliminated or better warnings provided, the entire 

“even though” clause is a useless appendage.49 It would 

suffice to say “if the injury or death resulted from side

effects that were unavoidable”—full stop. 

—————— 

performed by “and.” No, we think “even though” has a distinctive 

concessive, subordinating role to play. 48Because the dissent has a superfluity problem of its own, its reliance on Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), is misplaced. See id., at 449 (adopting an interpretation that was “the only

one that makes sense of each phrase” in the relevant statute). 49That is true regardless of whether §300aa–22(b)(1) incorporates 

comment k. See Restatement §402A, Comment k, pp. 353, 354 (noting

that “unavoidably unsafe products” are exempt from strict liability

“with the qualification that they are properly prepared and marketed,

and proper warning is given”). 
Cite as: 562 U. S. ____ (2011) 13 

Opinion of the Court 

III 

The structure of the NCVIA and of vaccine regulation in 

general reinforces what the text of §300aa–22(b)(1) suggests. A vaccine’s license spells out the manufacturing

method that must be followed and the directions and 

warnings that must accompany the product.50 Manufacturers ordinarily must obtain the Food and Drug Administration’s (FDA) approval before modifying either.51 Deviations from the license thus provide objective evidence of

manufacturing defects or inadequate warnings. Further 

objective evidence comes from the FDA’s regulations—

more than 90 of them52—that pervasively regulate the 

manufacturing process, down to the requirements for 

plumbing and ventilation systems at each manufacturing

facility.53 Material noncompliance with any one of them, 

or with any other FDA regulation, could cost the manufacturer its regulatory-compliance defense.54 

Design defects, in contrast, do not merit a single mention in the NCVIA or the FDA’s regulations. Indeed, the 

FDA has never even spelled out in regulations the criteria 

it uses to decide whether a vaccine is safe and effective for 

its intended use.55 And the decision is surely not an easy 

one. Drug manufacturers often could trade a little less

efficacy for a little more safety, but the safest design is not 

always the best one. Striking the right balance between 

safety and efficacy is especially difficult with respect to 

vaccines, which affect public as well as individual health.

Yet the Act, which in every other respect micromanages

manufacturers, is silent on how to evaluate competing 

designs. Are manufacturers liable only for failing to em-

—————— 

50See 42 U. S. C. §262(a), (j); 21 CFR §§601.2(a), 314.105(b) (2010). 51See §601.12. 

52See §§211.1 et seq., 600.10–600.15, 600.21–600.22, 820.1 et seq. 53See §§211.46, 211.48. 54See 42 U. S. C. §300aa–22(b)(2). 55Hutt, Merrill, & Grossman, Food and Drug Law, at 685, 891. 
14 BRUESEWITZ v. WYETH LLC 

Opinion of the Court 

ploy an alternative design that the FDA has approved for

distribution (an approval it takes years to obtain56)? Or 

does it suffice that a vaccine design has been approved in

other countries? Or could there be liability for failure to

use a design that exists only in a lab? Neither the Act nor 

the FDA regulations provide an answer, leaving the universe of alternative designs to be limited only by an expert’s imagination. 

Jurors, of course, often decide similar questions with

little guidance, and we do not suggest that the absence

of guidance alone suggests preemption. But the lack of 

guidance for design defects combined with the extensive guidance for the two grounds of liability specifically

mentioned in the Act strongly suggests that design defects 

were not mentioned because they are not a basis for 

liability.

The mandates contained in the Act lead to the same 

conclusion. Design-defect torts, broadly speaking, have

two beneficial effects: (1) prompting the development of

improved designs, and (2) providing compensation for 

inflicted injuries. The NCVIA provides other means for

achieving both effects. We have already discussed the

Act’s generous compensation scheme. And the Act provides many means of improving vaccine design. It directs 

the Secretary of Health and Human Services to promote 

“the development of childhood vaccines that result in

fewer and less serious adverse reactions.”57 It establishes 

a National Vaccine Program, whose Director is “to achieve 

optimal prevention of human infectious diseases . . . and to 

achieve optimal prevention against adverse reactions.”58 

The Program is to set priorities for federal vaccine research, and to coordinate federal vaccine safety and effi-

—————— 

56See Sing & William, Supplying Vaccines, at 66–67. 57 42 U. S. C. §300aa–27(a)(1). 58 §300aa–1. 
Cite as: 562 U. S. ____ (2011) 15 

Opinion of the Court 

cacy testing.59 The Act requires vaccine manufacturers

and health-care providers to report adverse side effects,60 

and provides for monitoring of vaccine safety through a

collaboration with eight managed-care organizations.61 

And of course whenever the FDA concludes that a vaccine 

is unsafe, it may revoke the license.62 

These provisions for federal agency improvement of 

vaccine design, and for federally prescribed compensation, 

once again suggest that §300aa–22(b)(1)’s silence regarding design-defect liability was not inadvertent. It instead 

reflects a sensible choice to leave complex epidemiological

judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.63 

And finally, the Act’s structural quid pro quo leads to 

the same conclusion: The vaccine manufacturers fund 

from their sales an informal, efficient compensation program for vaccine injuries;64 in exchange they avoid costly 

tort litigation and the occasional disproportionate jury

verdict.65 But design-defect allegations are the most

speculative and difficult type of products liability claim to 

—————— 

59See §§300aa–2(a)(1)–(3), 300aa–3. 60See §300aa–25(b). 61See NVAC 18–19. 62See 21 CFR §601.5(b)(1)(vi) (2010). 63The dissent quotes just part of this sentence, to make it appear that

we believe complex epidemiological judgments ought to be assigned in 

that fashion. See post, at 26. We do not state our preference, but

merely note that it is Congress’s expressed preference—and in order to

preclude the argument that it is absurd to think Congress enacted such

a thing, we assert that the choice is reasonable and express some of the

reasons why. Leaving it to the jury may (or may not) be reasonable as

well; we express no view. 64See 42 U. S. C. §300aa–15(i)(2); Pub. L. 99–660, §323(a), 100 Stat. 

3784. The dissent’s unsupported speculation that demand in the 

vaccine market is inelastic, see post, at 24, n. 22, sheds no light on

whether Congress regarded the tax as a quid pro quo, most Members of 

Congress being neither professional economists nor law-and-economics 

scholars. 65See 42 U. S. C. §§300aa–11(a)(2), 300aa–22. 
16 BRUESEWITZ v. WYETH LLC 

Opinion of the Court 

litigate. Taxing vaccine manufacturers’ product to fund

the compensation program, while leaving their liability for 

design defect virtually unaltered, would hardly coax 

manufacturers back into the market. 

The dissent believes the Act’s mandates are irrelevant 

because they do not spur innovation in precisely the same

way as state-law tort systems.66 That is a novel suggestion. Although we previously have expressed doubt that 

Congress would quietly preempt product-liability claims

without providing a federal substitute, see Medtronic, Inc. 

v. Lohr, 518 U. S. 470, 486–488 (1996) (plurality opinion),

we have never suggested we would be skeptical of preemption unless the congressional substitute operated like the 

tort system. We decline to adopt that stance today. The 

dissent’s belief that the FDA and the National Vaccine 

Program cannot alone spur adequate vaccine innovation is

probably questionable, but surely beside the point. 

IV 

Since our interpretation of §300aa–22(b)(1) is the only 

interpretation supported by the text and structure of the

NCVIA, even those of us who believe legislative history is 

a legitimate tool of statutory interpretation have no need 

to resort to it. In any case, the dissent’s contention that it

would contradict our conclusion is mistaken. 

The dissent’s legislative history relies on the following 

syllogism: A 1986 House Committee Report states that

§300aa–22(b)(1) “sets forth the principle contained in

Comment k of Section 402A of the Restatement of Torts 

(Second);”67 in 1986 comment k was “commonly understood” to require a case-specific showing that “no feasible 

alternative design” existed; Congress therefore must have 

intended §300aa–22(b)(1) to require that showing.68 The 

—————— 

66See post, at 21–24. 67H. R. Rep. No. 99–908, pt. 1, p. 25 (1986) (hereinafter 1986 Report). 68 Post, at 7–8. 
Cite as: 562 U. S. ____ (2011) 17 

Opinion of the Court 

syllogism ignores unhelpful statements in the Report and

relies upon a term of art that did not exist in 1986. 

Immediately after the language quoted by the dissent, 

the 1986 Report notes the difficulty a jury would have in 

faithfully assessing whether a feasible alternative design

exists when an innocent “young child, often badly injured

or killed” is the plaintiff.69 Eliminating that concern is

why the Report’s authors “strongly believ[e] that Comment k is appropriate and necessary as the policy for civil

actions seeking damages in tort.”70 The dissent’s interpretation of §300aa–22(b)(1) and its version of “the principle

in Comment K” adopted by the 1986 Report leave that

concern unaddressed. 

The dissent buries another unfavorable piece of legislative history. Because the Report believes that §300aa–

22(b)(1) should incorporate “the principle in Comment K”

and because the Act provides a generous no-fault compensation scheme, the Report counsels injured parties who

cannot prove a manufacturing or labeling defect to “pursue 

recompense in the compensation system, not the tort

system.”71 That counsel echoes our interpretation of 

§300aa–22(b)(1). 

Not to worry, the dissent retorts, a Committee Report by

a later Congress “authoritative[ly]” vindicates its interpretation.72 Post-enactment legislative history (a contradiction in terms) is not a legitimate tool of statutory interpretation. See Jones v. United States, 526 U. S. 227, 238 

—————— 

69 1986 Report, at 26; see ibid. (“[E]ven if the defendant manufacturer 

may have made as safe a vaccine as anyone reasonably could expect, a

court or jury undoubtedly will find it difficult to rule in favor of the 

‘innocent’ manufacturer if the equally ‘innocent’ child has to bear the

risk of loss with no other possibility of recompense”). 70 Ibid. 

71 Ibid. 

72 Post, at 12. This is a courageous adverb since we have previously

held that the only authoritative source of statutory meaning is the text 

that has passed through the Article I process. See Exxon Mobil Corp. v. 

Allapattah Services, Inc., 545 U. S. 546, 568 (2005). 
18 BRUESEWITZ v. WYETH LLC 

Opinion of the Court 

(1999); United States v. Mine Workers, 330 U. S. 258, 281– 

282 (1947). Real (pre-enactment) legislative history is

persuasive to some because it is thought to shed light on

what legislators understood an ambiguous statutory text 

to mean when they voted to enact it into law. See Exxon 

Mobil Corp. v. Allapattah Services, Inc., 545 U. S. 546, 568 

(2005). But post-enactment legislative history by definition “could have had no effect on the congressional vote,”

District of Columbia v. Heller, 554 U. S. 570, 605 (2008). 

It does not matter that §300aa–22(b)(1) did not take

effect until the later Congress passed the excise tax that

funds the compensation scheme,73 and that the supposedly

dispositive Committee Report is attached to that funding

legislation.74 Those who voted on the relevant statutory 

language were not necessarily the same persons who

crafted the statements in the later Committee Report; or if

they were did not necessarily have the same views at that 

earlier time; and no one voting at that earlier time could 

possibly have been informed by those later statements. 

Permitting the legislative history of subsequent funding 

legislation to alter the meaning of a statute would set a

dangerous precedent. Many provisions of federal law 

depend on appropriations or include sunset provisions;75 

they cannot be made the device for unenacted statutory 

revision. 

That brings us to the second flaw in the dissent’s syllogism: Comment k did not have a “commonly understood 

meaning”76 in the mid-1980’s. Some courts thought it 

required a case-specific showing that a product was “unavoidably unsafe”; many others thought it categorically 

exempted certain types of products from strict liability.77 

—————— 

73Pub. L. 99–960, §323(a), 100 Stat. 3784. 74H. R. Rep. No. 100–391, pt. 1, p. 701 (1987). 75See, e.g., Pub. L. 104–208, §§401, 403(a), 110 Stat. 3009–655 to 

3009–656, 3009–659 to 3009–662, as amended, note following 8 U. S. C. 

§1324a (2006 ed., Supp. III) (E-Verify program expires Sept. 30, 2012). 76 Post, at 8. 77See n. 39, supra; post, at 7–8, n. 5. 
Cite as: 562 U. S. ____ (2011) 19 

Opinion of the Court 

When “all (or nearly all) of the” relevant judicial decisions 

have given a term or concept a consistent judicial gloss, we 

presume Congress intended the term or concept to have

that meaning when it incorporated it into a later-enacted 

statute. Merck & Co. v. Reynolds, 559 U. S. ___, ___ (2010)

(SCALIA, J., concurring in part and concurring in judgment) (slip op., at 5). The consistent gloss represents 

the public understanding of the term. We cannot make the 

same assumption when widespread disagreement exists

among the lower courts. We must make do with giving the

term its most plausible meaning using the traditional 

tools of statutory interpretation. That is what we have 

done today. 

* * * 

For the foregoing reasons, we hold that the National

Childhood Vaccine Injury Act preempts all design-defect 

claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by 

vaccine side effects. The judgment of the Court of Appeals 

is affirmed. 

It is so ordered. 

JUSTICE KAGAN took no part in the consideration or 

decision of this case. 
_________________ 

_________________ 

Cite as: 562 U. S. ____ (2011) 1 

BREYER, J., concurring 

SUPREME COURT OF THE UNITED STATES 

No. 09–152 

RUSSELL BRUESEWITZ, ET AL., PETITIONERS v. 

WYETH LLC, FKA WYETH, INC., FKA WYETH

LABORATORIES, ET AL. 

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE THIRD CIRCUIT

 [February 22, 2011] 

JUSTICE BREYER, concurring. 

I join the Court’s judgment and opinion. In my view,

the Court has the better of the purely textual argument. 

But the textual question considered alone is a close 

one. Hence, like the dissent, I would look to other 

sources, including legislative history, statutory purpose, 

and the views of the federal administrative agency, here

supported by expert medical opinion. Unlike the dissent, 

however, I believe these other sources reinforce the 

Court’s conclusion. 

I 

House Committee Report 99–908 contains an “authoritative” account of Congress’ intent in drafting the preemption clause of the National Childhood Vaccine Injury

Act of 1986 (NCVIA or Act). See Garcia v. United States, 

469 U. S. 70, 76 (1984) (“[T]he authoritative source for 

finding the Legislature’s intent lies in the Committee

Reports on the bill”). That Report says that, “if” vaccineinjured persons 

“cannot demonstrate under applicable law either that

a vaccine was improperly prepared or that it was accompanied by improper directions or inadequate 

warnings [they] should pursue recompense in the 
2 BRUESEWITZ v. WYETH LLC 

BREYER, J., concurring 

compensation system, not the tort system.” H. R. Rep.

No. 99–908, pt. 1, p. 24 (1986) (hereinafter H. R.

Rep.). 

The Report lists two specific kinds of tort suits that the 

clause does not pre-empt (suits based on improper manufacturing and improper labeling), while going on to state 

that compensation for other tort claims, e.g., design-defect

claims, lies in “the [NCVIA’s no-fault] compensation system, not the tort system.” Ibid. 

The strongest contrary argument rests upon the Report’s earlier description of the statute as “set[ting] forth

the principle contained in Comment k” (of the Restatement Second of Torts’ strict liability section, 402A) that “a

vaccine manufacturer should not be liable for injuries or 

deaths resulting from unavoidable side effects.” Id., at 23 

(emphasis added). But the appearance of the word “unavoidable” in this last-mentioned sentence cannot provide 

petitioners with much help. That is because nothing in

the Report suggests that the statute means the word 

“unavoidable” to summon up an otherwise unmentioned 

third exception encompassing suits based on design defects. Nor can the Report’s reference to comment k fill the 

gap. The Report itself refers, not to comment k’s details, 

but only to its “principle,” namely, that vaccine manufacturers should not be held liable for unavoidable injuries.

It says nothing at all about who—judge, jury, or federal

safety agency—should decide whether a safer vaccine 

could have been designed. Indeed, at the time Congress

wrote this Report, different state courts had come to very

different conclusions about that matter. See Cupp, Rethinking Conscious Design Liability for Prescription 

Drugs: The Restatement (Third) Standard Versus a Negligence Approach, 63 Geo. Wash. L. Rev. 76, 79 (1994–1995) 

(“[C]ourts [had] adopted a broad range of conflicting interpretations” of comment k). Neither the word “unavoid-
Cite as: 562 U. S. ____ (2011) 3 

BREYER, J., concurring 

able” nor the phrase “the principle of Comment k” tells us

which courts’ view Congress intended to adopt. Silence 

cannot tell us to follow those States where juries decided 

the design-defect question. 

II 

The legislative history describes the statute more generally as trying to protect the lives of children, in part

by ending “the instability and unpredictability of the

childhood vaccine market.” H. R. Rep., at 7; see ante, at 

2–3. As the Committee Report makes clear, routine vaccination is “one of the most spectacularly effective public

health initiatives this country has ever undertaken.” 

H. R. Rep., at 4. Before the development of routine whooping cough vaccination, for example, “nearly all children”

in the United States caught the disease and more than 

4,000 people died annually, most of them infants. U. S. 

Dept. of Health and Human Services, Centers for Disease 

Control and Prevention, What Would Happen if We

Stopped Vaccinations? http://www.cdc.gov/vaccines/vac-gen/ 

whatifstop.htm (all Internet materials as visited Feb. 17, 

2011, and available in Clerk of Court’s case file); Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diptheria Toxoid 

and Acellular Pertussis Vaccines, 55 Morbidity and Mortality Weekly Report, No. RR–3, p. 2 (Mar. 24, 2006) (hereinafter Preventing Tetanus) (statistics for 1934–1943),

http://www.cdc.gov/mmwr/PDF/rr/rr5503.pdf; U. S. Dept.

of Health and Human Services, Centers for Disease Control and Prevention, Epidemiology and Prevention of 

Vaccine-Preventable Diseases 200 (11th ed. rev. May 

2009). After vaccination became common, the number of 

annual cases of whooping cough declined from over 

200,000 to about 2,300, and the number of deaths from 

about 4,000 to about 12. Preventing Tetanus 2; Childhood 

Immunizations, House Committee on Energy and Com-
4 BRUESEWITZ v. WYETH LLC 

BREYER, J., concurring 

merce, 99th Cong., 2d Sess., 10 (Comm. Print 1986) (hereinafter Childhood Immunizations).

But these gains are fragile; “[t]he causative agents for

these preventable childhood illnesses are ever present in 

the environment, waiting for the opportunity to attack 

the unprotected individual.” Hearing on S. 827 before the

Senate Committee on Labor and Human Resources, 99th 

Cong., 2d Sess., pt. 2, pp. 20–21 (1985) (hereinafter Hearings) (testimony of the American Academy of Pediatrics);

see California Dept. of Public Health, Pertussis Report (Jan. 7, 2011), www.cdph.ca.gov/programs/immunize/

Documents/PertussisReport2011–01–07.pdf (In 2010, 

8,383 people in California caught whooping cough, and 10

infants died). Even a brief period when vaccination programs are disrupted can lead to children’s deaths. Hearings 20–21; see Gangarosa et al., Impact of Anti-Vaccine

Movements on Pertussis Control: The Untold Story, 351

Lancet 356–361 (Jan. 31, 1998) (when vaccination programs are disrupted, the number of cases of whooping 

cough skyrockets, increasing by orders of magnitude). 

In considering the NCVIA, Congress found that a sharp

increase in tort suits brought against whooping cough and 

other vaccine manufacturers between 1980 and 1985 had 

“prompted manufacturers to question their continued 

participation in the vaccine market.” H. R. Rep., at 4;

Childhood Immunizations 85–86. Indeed, two whooping 

cough vaccine manufacturers withdrew from the market,

and other vaccine manufacturers, “fac[ing] great difficulty 

in obtaining [product liability] insurance,” told Congress

that they were considering “a similar course of action.”

H. R. Rep., at 4; Childhood Immunizations 68–70. The 

Committee Report explains that, since there were only one

or two manufacturers of many childhood vaccines, “[t]he 

loss of any of the existing manufacturers of childhood 

vaccines . . . could create a genuine public health hazard”;

it “would present the very real possibility of vaccine short-
Cite as: 562 U. S. ____ (2011) 5 

BREYER, J., concurring 

ages, and, in turn, increasing numbers of unimmunized 

children, and, perhaps, a resurgence of preventable diseases.” H. R. Rep., at 5. At the same time, Congress 

sought to provide generous compensation to those whom

vaccines injured—as determined by an expert compensation program. Id., at 5, 24. 

Given these broad general purposes, to read the preemption clause as preserving design-defect suits seems 

anomalous. The Department of Health and Human 

Services (HHS) decides when a vaccine is safe enough to

be licensed and which licensed vaccines, with which 

associated injuries, should be placed on the Vaccine Injury Table. 42 U. S. C. §300aa–14; ante, at 3–4; A 

Comprehensive Review of Federal Vaccine Safety Programs and Public Health Activities 13–15, 32–34 

(Dec. 2008), http://www.hhs.gov/nvpo/nvac/documents/

vaccine-safety-review.pdf. A special master in the Act’s 

compensation program determines whether someone has

suffered an injury listed on the Injury Table and, if not, 

whether the vaccine nonetheless caused the injury. Ante, 

at 3–4; §300aa–13. To allow a jury in effect to secondguess those determinations is to substitute less expert for

more expert judgment, thereby threatening manufacturers 

with liability (indeed, strict liability) in instances where 

any conflict between experts and nonexperts is likely to be

particularly severe—instances where Congress intended

the contrary. That is because potential tort plaintiffs are 

unlikely to bring suit unless the specialized compensation 

program has determined that they are not entitled to

compensation (say, because it concludes that the vaccine 

did not cause the injury). Brief for United States as 

Amicus Curiae 28 (“99.8% of successful Compensation

Program claimants have accepted their awards, foregoing 

any tort remedies against vaccine manufacturers”). It is 

difficult to reconcile these potential conflicts and the resulting tort liabilities with a statute that seeks to diminish 
6 BRUESEWITZ v. WYETH LLC 

BREYER, J., concurring 

manufacturers’ product liability while simultaneously 

augmenting the role of experts in making compensation 

decisions. 

III 

The United States, reflecting the views of HHS, urges 

the Court to read the Act as I and the majority would do.

It notes that the compensation program’s listed vaccines 

have survived rigorous administrative safety review. It 

says that to read the Act as permitting design-defect

lawsuits could lead to a recurrence of “exactly the crisis 

that precipitated the Act,” namely withdrawals of vaccines 

or vaccine manufacturers from the market, “disserv[ing] 

the Act’s central purposes,” and hampering the ability of 

the agency’s “expert regulators, in conjunction with the

medical community, [to] control the availability and withdrawal of a given vaccine.” Brief for United States as 

Amicus Curiae 30, 31. 

The United States is supported in this claim by leading 

public health organizations, including the American Academy of Pediatrics, the American Academy of Family Physicians, the American College of Preventive Medicine, the

American Public Health Association, the American Medical Association, the March of Dimes Foundation, the Pediatric Infectious Diseases Society, and 15 other similar 

organizations. Brief for American Academy of Pediatrics

et al. as Amici Curiae (hereinafter AAP Brief). The American Academy of Pediatrics has also supported the retention of vaccine manufacturer tort liability (provided that 

federal law structured state-law liability conditions in

ways that would take proper account of federal agency 

views about safety). Hearings 14–15. But it nonetheless 

tells us here, in respect to the specific question before us,

that the petitioners’ interpretation of the Act would undermine its basic purposes by threatening to “halt the

future production and development of childhood vaccines 
Cite as: 562 U. S. ____ (2011) 7 

BREYER, J., concurring 

in this country,” i.e., by “threaten[ing] a resurgence of the 

very problems which . . . caused Congress to intervene” by

enacting this statute. AAP Brief 24 (internal quotation

marks omitted). 

I would give significant weight to the views of HHS.

The law charges HHS with responsibility for overseeing 

vaccine production and safety. It is “likely to have a thorough understanding” of the complicated and technical

subject matter of immunization policy, and it is comparatively more “qualified to comprehend the likely impact of

state requirements.” Geier v. American Honda Motor Co., 

Inc., 529 U. S. 861, 883 (2000) (internal quotation marks 

omitted); see Medtronic, Inc. v. Lohr, 518 U. S. 470, 506 

(1996) (BREYER, J., concurring in part and concurring in

judgment) (the agency is in the best position to determine 

“whether (or the extent to which) state requirements may

interfere with federal objectives”). HHS’s position is particularly persuasive here because expert public health

organizations support its views and the matter concerns a

medical and scientific question of great importance: how

best to save the lives of children. See Skidmore v. Swift & 

Co., 323 U. S. 134 (1944).

In sum, congressional reports and history, the statute’s

basic purpose as revealed by that history, and the views of 

the expert agency along with those of relevant medical and 

scientific associations, all support the Court’s conclusions. 

I consequently agree with the Court. 
_________________ 

_________________ 

Cite as: 562 U. S. ____ (2011) 1 

SOTOMAYOR, J., dissenting 

SUPREME COURT OF THE UNITED STATES 

No. 09–152 

RUSSELL BRUESEWITZ, ET AL., PETITIONERS v. 

WYETH LLC, FKA WYETH, INC., FKA WYETH

LABORATORIES, ET AL. 

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE THIRD CIRCUIT

 [February 22, 2011] 

JUSTICE SOTOMAYOR, with whom JUSTICE GINSBURG 

joins, dissenting. 

Vaccine manufacturers have long been subject to a legal

duty, rooted in basic principles of products liability law, to 

improve the designs of their vaccines in light of advances 

in science and technology. Until today, that duty was

enforceable through a traditional state-law tort action for

defective design. In holding that §22(b)(1) of the National

Childhood Vaccine Injury Act of 1986 (Vaccine Act or Act),

42 U. S. C. §300aa–22(b)(1), pre-empts all design defect 

claims for injuries stemming from vaccines covered under

the Act, the Court imposes its own bare policy preference 

over the considered judgment of Congress. In doing so, 

the Court excises 13 words from the statutory text, misconstrues the Act’s legislative history, and disturbs the 

careful balance Congress struck between compensating

vaccine-injured children and stabilizing the childhood

vaccine market. Its decision leaves a regulatory vacuum

in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.

Because nothing in the text, structure, or legislative history of the Vaccine Act remotely suggests that Congress 

intended such a result, I respectfully dissent. 
2 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

I 

A 

Section 22 of the Vaccine Act provides “[s]tandards of

responsibility” to govern civil actions against vaccine

manufacturers. 42 U. S. C. §300aa–22. Section 22(a) sets 

forth the “[g]eneral rule” that “State law shall apply to a

civil action brought for damages for a vaccine-related

injury or death.” §300aa–22(a). This baseline rule that 

state law applies is subject to three narrow exceptions, one 

of which, §22(b)(1), is at issue in this case. Section 22(b)(1)

provides: 

“No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury

or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even 

though the vaccine was properly prepared and was 

accompanied by proper directions and warnings.” 

§300aa–22(b)(1). 

The provision contains two key clauses: “if the injury or

death resulted from side effects that were unavoidable” 

(the “if” clause), and “even though the vaccine was properly prepared and was accompanied by proper directions

and warnings” (the “even though” clause). 

Blackletter products liability law generally recognizes

three different types of product defects: design defects, 

manufacturing defects, and labeling defects (e.g., failure to 

warn).1 The reference in the “even though” clause to a 

“properly prepared” vaccine “accompanied by proper directions and warnings” is an obvious reference to two such 

defects—manufacturing and labeling defects. The plain

terms of the “even though” clause thus indicate that 

—————— 

1W. Keeton, D. Dobbs, R. Keeton, & D. Owen, Prosser and Keeton on 

Law of Torts 695 (5th ed. 1984). 
Cite as: 562 U. S. ____ (2011) 3 

SOTOMAYOR, J., dissenting 

§22(b)(1) applies only where neither kind of defect is present. Because §22(b)(1) is invoked by vaccine manufacturers as a defense to tort liability, it follows that the “even

though” clause requires a vaccine manufacturer in each 

civil action to demonstrate that its vaccine is free from 

manufacturing and labeling defects to fall within the 

liability exemption of §22(b)(1).2 

Given that the “even though” clause requires the absence of manufacturing and labeling defects, the “if” 

clause’s reference to “side effects that were unavoidable” 

must refer to side effects caused by something other than

manufacturing and labeling defects. The only remaining

kind of product defect recognized under traditional products liability law is a design defect. Thus, “side effects 

that were unavoidable” must refer to side effects caused by

a vaccine’s design that were “unavoidable.” Because 

§22(b)(1) uses the conditional term “if,” moreover, the text

plainly implies that some side effects stemming from a

vaccine’s design are “unavoidable,” while others are avoidable. See Webster’s Third New International Dictionary 

1124 (2002) (“if” means “in the event that,” “so long as,” or

“on condition that”). Accordingly, because the “if” clause 

(like the “even though” clause) sets forth a condition to 

invoke §22(b)(1)’s defense to tort liability, Congress must 

also have intended a vaccine manufacturer to demonstrate 

in each civil action that the particular side effects of a

vaccine’s design were “unavoidable.” 

Congress’ use of conditional “if” clauses in two other 

provisions of the Vaccine Act supports the conclusion that

§22(b)(1) requires an inquiry in each case in which a 

manufacturer seeks to invoke the provision’s exception to 

—————— 

2See Silkwood v. Kerr-McGee Corp., 464 U. S. 238, 255 (1984); Brown 

v. Earthboard Sports USA, Inc., 481 F. 3d 901, 912 (CA6 2007) 

(“ ‘[F]ederal preemption is an affirmative defense upon which the 

defendants bear the burden of proof’” (quoting Fifth Third Bank v. 

CSX Corp., 415 F. 3d 741, 745 (CA7 2005))). 
4 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

state tort liability. In §22(b)(2), Congress created a presumption that, for purposes of §22(b)(1), “a vaccine shall

be presumed to be accompanied by proper directions and 

warnings if the vaccine manufacturer shows that it complied in all material respects with” federal labeling requirements. 42 U. S. C. §300aa–22(b)(2). Similarly, in

§23(d)(2), Congress created an exemption from punitive

damages “[i]f . . . the manufacturer shows that it complied,

in all material respects,” with applicable federal laws,

unless it engages in “fraud,” “intentional and wrongful

withholding of information” from federal regulators, or 

“other criminal or illegal activity.” §300aa–23(d)(2). It 

would be highly anomalous for Congress to use a conditional “if” clause in §§22(b)(2) and 23(d)(2) to require a

specific inquiry in each case while using the same conditional “if” clause in §22(b)(1) to denote a categorical exemption from liability. Cf. Erlenbaugh v. United States, 

409 U. S. 239, 243 (1972) (“[A] legislative body generally 

uses a particular word with a consistent meaning in a

given context”).

Indeed, when Congress intends to pre-empt design

defect claims categorically, it does so using categorical

(e.g., “all”) and/or declarative language (e.g., “shall”),

rather than a conditional term (“if”). For example, in

a related context, Congress has authorized the Secretary

of Health and Human Services to designate a vaccine 

designed to prevent a pandemic or epidemic as a “covered 

countermeasure.” 42 U. S. C. §§247d–6d(b), (i)(1),

(i)(7)(A)(i). With respect to such “covered countermeasure[s],” Congress provided that subject to certain exceptions, “a covered person shall be immune from suit and 

liability under Federal and State law with respect to all 

claims for loss caused by, arising out of, relating to, or 

resulting from the administration to or the use by an

individual of a covered countermeasure,” §247d–6d(a)(1) 

(emphasis added), including specifically claims relating to 
Cite as: 562 U. S. ____ (2011) 5 

SOTOMAYOR, J., dissenting 

“the design” of the countermeasure, §247d–6d(a)(2)(B).

The plain text and structure of the Vaccine Act thus

compel the conclusion that §22(b)(1) pre-empts some—but

not all—design defect claims. Contrary to the majority’s

and respondent’s categorical reading, petitioners correctly 

contend that, where a plaintiff has proved that she has 

suffered an injury resulting from a side effect caused by

a vaccine’s design, a vaccine manufacturer may invoke 

§22(b)(1)’s liability exemption only if it demonstrates that 

the side effect stemming from the particular vaccine’s

design is “unavoidable,” and that the vaccine is otherwise

free from manufacturing and labeling defects.3 

B 

The legislative history confirms petitioners’ interpretation of §22(b)(1) and sheds further light on its pre-emptive 

scope. The House Energy and Commerce Committee 

Report accompanying the Vaccine Act, H. R. Rep. No. 99–

908, pt. 1 (1986) (hereinafter 1986 Report), explains in

relevant part: 

“Subsection (b)—Unavoidable Adverse Side Effects; 

Direct Warnings.—This provision sets forth the principle contained in Comment K of Section 402A of the 

Restatement of Torts (Second) that a vaccine manufacturer should not be liable for injuries or deaths resulting from unavoidable side effects even though the 

vaccine was properly prepared and accompanied by

proper directions and warnings. 

“The Committee has set forth Comment K in this 

bill because it intends that the principle in Comment

K regarding ‘unavoidably unsafe’ products, i.e., those 

products which in the present state of human skill 

and knowledge cannot be made safe, apply to the vac-

—————— 

3This leaves the question of what precisely §22(b)(1) means by “unavoidable” side effects, which I address in the next section. 
6 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

cines covered in the bill and that such products not be

the subject of liability in the tort system.” Id., at 25– 

26. 

The Report expressly adopts comment k of §402A of the 

Restatement of Torts (Second) (1963–1964) (hereinafter

Restatement), which provides that “unavoidably unsafe” 

products—i.e., those that “in the present state of human 

knowledge, are quite incapable of being made safe for 

their intended and ordinary use”—are not defective.4 As 

“[a]n outstanding example” of an “[u]navoidably unsafe” 

product, comment k cites “the vaccine for the Pasteur 

treatment of rabies, which not uncommonly leads to very 

serious and damaging consequences when it is injected”; 

—————— 

4Comment k provides as follows: 

“Unavoidably unsafe products. There are some products which, in 

the present state of human knowledge, are quite incapable of being

made safe for their intended and ordinary use. These are especially 

common in the field of drugs. An outstanding example is the vaccine 

for the Pasteur treatment of rabies, which not uncommonly leads to

very serious and damaging consequences when it is injected. Since the 

disease itself invariably leads to a dreadful death, both the marketing 

and the use of the vaccine are fully justified, notwithstanding the 

unavoidable high degree of risk which they involve. Such a product,

properly prepared, and accompanied by proper directions and warning,

is not defective, nor is it unreasonably dangerous. The same is true of 

many other drugs, vaccines, and the like, many of which for this very

reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or

experimental drugs as to which, because of lack of time and opportunity 

for sufficient medical experience, there can be no assurance of safety, or 

perhaps even of purity of ingredients, but such experience as there is 

justifies the marketing and use of the drug notwithstanding a medically 

recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning 

is given, where the situation calls for it, is not to be held to strict

liability for unfortunate consequences attending their use, merely 

because he has undertaken to supply the public with an apparently

useful and desirable product, attended with a known but apparently 

reasonable risk.” Restatement 353–354. 
Cite as: 562 U. S. ____ (2011) 7 

SOTOMAYOR, J., dissenting 

“[s]ince the disease itself invariably leads to a dreadful

death, both the marketing and the use of the vaccine are 

fully justified, notwithstanding the unavoidable high

degree of risk which they involve.” Id., at 353. Comment 

k thus provides that “seller[s]” of “[u]navoidably unsafe” 

products are “not to be held to strict liability” provided 

that such products “are properly prepared and marketed, 

and proper warning is given.” Ibid. 

As the 1986 Report explains, Congress intended that the

“principle in Comment K regarding ‘unavoidably unsafe’ 

products” apply to the vaccines covered in the bill. 1986 

Report 26. That intent, in turn, is manifested in the plain

text of §22(b)(1)—in particular, Congress’ use of the word

“unavoidable,” as well as the phrases “properly prepared”

and “accompanied by proper directions and warnings,” 

which were taken nearly verbatim from comment k. 42 

U. S. C. §300aa–22(b)(1); see Restatement 353–354 (“Such

a[n unavoidably unsafe] product, properly prepared, and 

accompanied by proper directions and warning, is not 

defective”). By the time of the Vaccine Act’s enactment in 

1986, numerous state and federal courts had interpreted 

comment k to mean that a product is “unavoidably unsafe”

when, given proper manufacture and labeling, no feasible 

alternative design would reduce the safety risks without

compromising the product’s cost and utility.5 Given Con-

—————— 

5See, e.g., Smith ex rel. Smith v. Wyeth Labs., Inc., No. Civ. A 84– 

2002, 1986 WL 720792, *5 (SD W. Va., Aug. 21, 1986) (“[A] prescription

drug is not ‘unavoidably unsafe’ when its dangers can be eliminated

through design changes that do not unduly affect its cost or utility”); 

Kearl v. Lederle Labs., 172 Cal. App. 3d 812, 830, 218 Cal. Rptr. 453,

464 (1985) (“unavoidability” turns on “(i) whether the product was

designed to minimize—to the extent scientifically knowable at the time

it was distributed—the risk inherent in the product, and (ii) the availability . . . of any alternative product that would have as effectively 

accomplished the full intended purpose of the subject product”), disapproved in part by Brown v. Superior Ct., 44 Cal. 3d 1049, 751 P. 2d 470 

(1988); Belle Bonfils Memorial Blood Bank v. Hansen, 665 P. 2d 118, 
8 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

gress’ expressed intent to codify the “principle in Comment 

K,” 1986 Report 26, the term “unavoidable” in §22(b)(1) is

best understood as a term of art, which incorporates the

commonly understood meaning of “unavoidably unsafe” 

products under comment k at the time of the Act’s enactment in 1986. See McDermott Int’l, Inc. v. Wilander, 498 

U. S. 337, 342 (1991) (“[W]e assume that when a statute

uses . . . a term [of art], Congress intended it to have its

established meaning”); Morissette v. United States, 342 

U. S. 246, 263 (1952) (same).6 Similarly, courts applying 

—————— 

122 (Colo. 1983) (“[A]pplicability of comment k . . . depends upon the coexistence of several factors,” including that “the product’s benefits must

not be achievable in another manner; and the risk must be unavoidable 

under the present state of knowledge”); see also 1 L. Frumer & M. 

Friedman, Products Liability §§8.07[1]–[2], pp. 8–277 to 8–278 (2010)

(comment k applies “only to defects in design,” and there “must be no 

feasible alternative design which on balance accomplishes the subject

product’s purpose with a lesser risk” (internal quotation marks omitted)). To be sure, a number of courts at the time of the Vaccine Act’s 

enactment had interpreted comment k to preclude design defect claims 

categorically for certain kinds of products, see Hill v. Searle Labs., 884 

F. 2d 1064, 1068 (CA8 1989) (collecting cases), but as indicated by the 

sources cited above, the courts that had construed comment k to apply

on a case-specific basis generally agreed on the basic elements of what 

constituted an “unavoidably unsafe” product. See also n. 8, infra. The 

majority’s suggestion that “judges who must rule on motions to dismiss,

motions for summary judgment, and motions for judgment as a matter

of law” are incapable of adjudicating claims alleging “unavoidable” side

effects, ante, at 7–8, n. 35, is thus belied by the experience of the many

courts that had adjudicated such claims for years by the time of the 

Vaccine Act’s enactment. 6The majority refuses to recognize that “unavoidable” is a term of art

derived from comment k, suggesting that “ ‘[u]navoidable’ is hardly a 

rarely used word.” Ante, at 10. In fact, however, “unavoidable” is an 

extremely rare word in the relevant context. It appears exactly once 

(i.e., in §300aa–22(b)(1)) in the entirety of Title 42 of the U. S. Code

(“Public Health and Welfare”), which governs, inter alia, Social Security, see 42 U. S. C. §301 et seq., Medicare, see §1395 et seq., and several 

other of the Federal Government’s largest entitlement programs. The 

singular rarity in which Congress used the term supports the conclu-
Cite as: 562 U. S. ____ (2011) 9 

SOTOMAYOR, J., dissenting 

comment k had long required manufacturers invoking

the defense to demonstrate that their products were not 

only “unavoidably unsafe” but also properly manufactured 

and labeled.7 By requiring “prope[r] prepar[ation]” and

“proper directions and warnings” in §22(b)(1), Congress

plainly intended to incorporate these additional comment 

k requirements.

The 1986 Report thus confirms petitioners’ interpretation of §22(b)(1). The Report makes clear that “side effects

that were unavoidable” in §22(b)(1) refers to side effects 

stemming from a vaccine’s design that were “unavoidable.” 

By explaining what Congress meant by the term “unavoidable,” moreover, the Report also confirms that

whether a side effect is “unavoidable” for purposes of 

§22(b)(1) involves a specific inquiry in each case as to 

whether the vaccine “in the present state of human skill 

and knowledge cannot be made safe,” 1986 Report 26—i.e., 

whether a feasible alternative design existed that would

have eliminated the adverse side effects of the vaccine 

without compromising its cost and utility. See Brief for 

Kenneth W. Starr et al. as Amici Curiae 14–15 (“If a particular plaintiff could show that her injury at issue was

avoidable . . . through the use of a feasible alternative

design for a specific vaccine, then she would satisfy the 

plain language of the statute, because she would have

demonstrated that the side effects were not unavoidable”).

Finally, the Report confirms that the “even though” clause 

is properly read to establish two additional prerequisites—

proper manufacturing and proper labeling—to qualify for 

—————— 

sion that “unavoidable” is a term of art. 7See, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 F. 2d 652, 657 

(CA1 1981); Needham v. White Labs., Inc., 639 F. 2d 394, 402 (CA7 

1981); Reyes v. Wyeth Labs., 498 F. 2d 1264, 1274–1275 (CA5 1974); 

Davis v. Wyeth Labs., 399 F. 2d 121, 127–129 (CA9 1968); Feldman v. 

Lederle Labs., 97 N. J. 429, 448, 479 A. 2d 374, 384 (1984); see also 

Toner v. Lederle Labs., 112 Idaho 328, 336, 732 P. 2d 297, 305 (1987). 
10 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

§22(b)(1)’s liability exemption.8 

In addition to the 1986 Report, one other piece of the

Act’s legislative history provides further confirmation of 

the petitioners’ textual reading of §22(b)(1). When Congress enacted the Vaccine Act in 1986, it did not initially 

include a source of payment for the no-fault compensation

program the Act established. The Act thus “made the 

compensation program and accompanying tort reforms

contingent on the enactment of a tax to provide funding 

—————— 

8Respondent suggests an alternative reading of the 1986 Report.

According to respondent, “the principle in Comment K” is simply that of 

nonliability for “unavoidably unsafe” products, and thus Congress’ 

stated intent in the 1986 Report to apply the “principle in Comment K”

to “the vaccines covered in the bill” means that Congress viewed the 

covered vaccines as a class to be “ ‘unavoidably unsafe.’ ” 1986 Report 

25–26; Brief for Respondent 42. The concurrence makes a similar 

argument. Ante, at 1–2 (opinion of BREYER, J.). This interpretation 

finds some support in the 1986 Report, which states that “if [injured

individuals] cannot demonstrate under applicable law either that a 

vaccine was improperly prepared or that it was accompanied by improper directions or inadequate warnings [they] should pursue recompense in the compensation system, not the tort system.” 1986 Report 

26. It also finds some support in the pre-Vaccine Act case law, which 

reflected considerable disagreement in the courts over “whether comment k applies to pharmaceutical products across the board or only on

a case-by-case basis.” Ausness, Unavoidably Unsafe Products and

Strict Products Liability: What Liability Rule Should be Applied to the 

Sellers of Pharmaceutical Products? 78 Ky. L. J. 705, 708, and n. 11 

(1989–1990) (collecting cases). This interpretation, however, is undermined by the fact that Congress has never directed the Food and Drug

Administration (FDA) or any other federal agency to review vaccines 

for optimal vaccine design, see infra, at 20–22, and n. 19, and thus it 

seems highly unlikely that Congress intended to eliminate the traditional mechanism for such review (i.e., design defect liability), particularly given its express retention of state tort law in the Vaccine Act, see 

42 U. S. C. §300aa–22(a). In any event, to the extent there is ambiguity 

as to how precisely Congress intended the “principle in Comment K” to 

apply to the covered vaccines, that ambiguity is explicitly resolved in

petitioners’ favor by the 1987 House Energy and Commerce Committee

Report, H. R. Rep. No. 100–391, pt. 1, pp. 690–691 (hereinafter 1987

Report). See infra this page and 11–12. 
Cite as: 562 U. S. ____ (2011) 11 

SOTOMAYOR, J., dissenting 

for the compensation.” 1987 Report 690. In 1987, Congress passed legislation to fund the compensation program. The House Energy and Commerce Committee 

Report9 accompanying that legislation specifically stated 

that “the codification of Comment (k) of The Restatement 

(Second) of Torts was not intended to decide as a matter of 

law the circumstances in which a vaccine should be 

deemed unavoidably unsafe.” Id., at 691. The Committee 

noted that “[a]n amendment to establish . . . that a manufacturer’s failure to develop [a] safer vaccine was not 

grounds for liability was rejected by the Committee during 

its original consideration of the Act.” Ibid. In light of that

rejection, the Committee emphasized that “there should be

no misunderstanding that the Act undertook to decide as a

matter of law whether vaccines were unavoidably unsafe 

or not,” and that “[t]his question is left to the courts to 

determine in accordance with applicable law.” Ibid. 

To be sure, postenactment legislative history created by

a subsequent Congress is ordinarily a hazardous basis

from which to infer the intent of the enacting Congress. 

See Sullivan v. Finkelstein, 496 U. S. 617, 631–632 (1990) 

(SCALIA, J., concurring in part). But unlike ordinary

postenactment legislative history, which is justifiably

given little or no weight, the 1987 Report reflects the 

intent of the Congress that enacted the funding legislation 

necessary to give operative effect to the principal provisions of the Vaccine Act, including §22(b)(1).10 Congress in 

—————— 

9The Third Circuit’s opinion below expressed uncertainty as to 

whether the 1987 Report was authored by the House Budget Committee or the House Energy and Commerce Committee. See 561 F. 3d 233, 

250 (2009). As petitioners explain, although the Budget Committee

compiled and issued the Report, the Energy and Commerce Committee

wrote and approved the relevant language. Title IV of the Report,

entitled “Committee on Energy and Commerce,” comprises “two Committee Prints approved by the Committee on Energy and Commerce for

inclusion in the forthcoming reconciliation bill.” 1987 Report 377, 380. 10The majority suggests that the 1987 legislation creating the fund-
12 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

1987 had a number of options before it, including adopting

an entirely different compensation scheme, as the Reagan

administration was proposing;11 establishing different

limitations on tort liability, including eliminating design

defect liability, as pharmaceutical industry leaders were 

advocating;12 or not funding the compensation program at 

all, which would have effectively nullified the relevant 

portions of the Act. Because the tort reforms in the 1986 

Act, including §22(b)(1), had no operative legal effect 

unless and until Congress provided funding for the compensation program, the views of the Congress that enacted 

that funding legislation are a proper and, indeed, authoritative guide to the meaning of §22(b)(1). Those views, as 

reflected in the 1987 Report, provide unequivocal confir-

—————— 

ing mechanism is akin to appropriations legislation and that giving 

weight to the legislative history of such legislation “would set a dangerous precedent.” Ante, at 18. The difference, of course, is that appropriations legislation ordinarily funds congressional enactments that

already have operative legal effect; in contrast, operation of the tort 

reforms in the 1986 Act, including §22(b)(1), was expressly conditioned 

on the enactment of a separate tax to fund the compensation program. 

See §323(a), 100 Stat. 3784. Accordingly, this Court’s general reluctance to view appropriations legislation as modifying substantive 

legislation, see, e.g., TVA v. Hill, 437 U. S. 153, 190 (1978), has no 

bearing here. 11See 1987 Report 700 (describing the administration’s alternative 

proposal). 12See, e.g., Hearings on Funding of the Childhood Vaccine Program

before the Subcommittee on Select Revenue Measures of the House 

Committee on Ways and Means, 100th Cong., 1st Sess., 85 (1987)

(“[T]he liability provisions of the 1986 Act should be amended to assure

that manufacturers will not be found liable in the tort system if they

have fully complied with applicable government regulations. In particular, manufacturers should not face liability under a ‘design defect’ 

theory in cases where plaintiffs challenge the decisions of public health 

authorities and federal regulators that the licensed vaccines are the

best available way to protect children from deadly diseases” (statement

of Robert B. Johnson, President, Lederle Laboratories Division, American Cyanamid Co.)). 
Cite as: 562 U. S. ____ (2011) 13 

SOTOMAYOR, J., dissenting 

mation of petitioners’ reading of §22(b)(1). 

In sum, the text, structure, and legislative history of the 

Vaccine Act are fully consistent with petitioners’ reading

of §22(b)(1). Accordingly, I believe §22(b)(1) exempts 

vaccine manufacturers from tort liability only upon a 

showing by the manufacturer in each case that the vaccine 

was properly manufactured and labeled, and that the side 

effects stemming from the vaccine’s design could not have

been prevented by a feasible alternative design that would 

have eliminated the adverse side effects without compromising the vaccine’s cost and utility. 

II 

In contrast to the interpretation of §22(b)(1) set forth

above, the majority’s interpretation does considerable violence to the statutory text, misconstrues the legislative

history, and draws the wrong conclusions from the structure of the Vaccine Act and the broader federal scheme 

regulating vaccines. 

A 

As a textual matter, the majority’s interpretation of

§22(b)(1) is fundamentally flawed in three central respects. First, the majority’s categorical reading rests on a

faulty and untenable premise. Second, its reading functionally excises 13 words from the statutory text, including

the key term “unavoidable.” And third, the majority entirely ignores the Vaccine Act’s default rule preserving

state tort law. 

To begin, the majority states that “[a] side effect of a 

vaccine could always have been avoidable by use of a

differently designed vaccine not containing the harmful

element.” Ante, at 7. From that premise, the majority

concludes that the statute must mean that “the design of 

the vaccine is a given, not subject to question in the tort 

action,” because construing the statute otherwise would 
14 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

render §22(b)(1) a nullity. Ibid. A tort claimant, according to the majority, will always be able to point to a differently designed vaccine not containing the “harmful element,” and if that were sufficient to show that a vaccine’s 

side effects were not “unavoidable,” the statute would preempt nothing.

The starting premise of the majority’s interpretation,

however, is fatally flawed. Although in the most literal

sense, as the majority notes, a side effect can always be 

avoided “by use of a differently designed vaccine not containing the harmful element,” ibid., this interpretation of

“unavoidable” would effectively read the term out of the

statute, and Congress could not have intended that result.

Indeed, §22(b)(1) specifically uses the conditional phrase

“if the injury or death resulted from side effects that were

unavoidable,” which plainly indicates that Congress contemplated that there would be some instances in which a

vaccine’s side effects are “unavoidable” and other instances in which they are not. See supra, at 3. The majority’s premise that a vaccine’s side effects can always be

“avoid[ed] by use of a differently designed vaccine not 

containing the harmful element,” ante, at 7, entirely ignores the fact that removing the “harmful element” will 

often result in a less effective (or entirely ineffective) 

vaccine. A vaccine, by its nature, ordinarily employs a

killed or weakened form of a bacteria or virus to stimulate 

antibody production;13 removing that bacteria or virus 

might remove the “harmful element,” but it would also

necessarily render the vaccine inert. As explained above,

the legislative history of the Vaccine Act and the cases

interpreting comment k make clear that a side effect is 

—————— 

13See American Academy of Pediatrics, Questions and Answers about 

Vaccine Ingredients (Oct. 2008), http://www.aap.org/immunization/ 

families/faq/Vaccineingredients.pdf (all Internet materials as visited 

Feb. 18, 2011, and available in Clerk of Court’s case file). 
Cite as: 562 U. S. ____ (2011) 15 

SOTOMAYOR, J., dissenting 

“unavoidable” for purposes of §22(b)(1) only where there is

no feasible alternative design that would eliminate the

side effect of the vaccine without compromising its cost 

and utility. See supra, at 7. The majority’s premise—that

side effects stemming from a vaccine’s design are always

avoidable—is thus belied by the statutory text and legislative history of §22(b)(1). And because its starting premise 

is invalid, its conclusion—that the design of a vaccine is

not subject to challenge in a tort action—is also necessarily invalid.

The majority’s reading suffers from an even more fundamental defect. If Congress intended to exempt vaccine

manufacturers categorically from all design defect liability, it more logically would have provided: “No vaccine

manufacturer shall be liable in a civil action for damages

arising from a vaccine-related injury or death associated 

with the administration of a vaccine after October 1, 1988, 

if the vaccine was properly prepared and was accompanied 

by proper directions and warnings.” There would have 

been no need for Congress to include the additional 13

words “the injury or death resulted from side effects that

were unavoidable even though.” See TRW Inc. v. Andrews, 534 U. S. 19, 31 (2001) (noting “cardinal principle 

of statutory construction that a statute ought, upon the

whole, to be so construed that, if it can be prevented, no 

clause, sentence, or word shall be superfluous, void, or

insignificant” (internal quotation marks omitted)). 

In Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005),

this Court considered an analogous situation where an

express pre-emption provision stated that certain States

“‘shall not impose or continue in effect any requirements

for labeling or packaging in addition to or different from

those required under this subchapter.’” Id., at 436 (quoting 7 U. S. C. §136v(b) (2000 ed.)). The Bates Court 

stated: 
16 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

“Conspicuously absent from the submissions by [respondent] and the United States is any plausible alternative interpretation of ‘in addition to or different 

from’ that would give that phrase meaning. Instead, 

they appear to favor reading those words out of the 

statute, which would leave the following: ‘Such State

shall not impose or continue in effect any requirements for labeling or packaging.’ This amputated 

version of [the statute] would no doubt have clearly 

and succinctly commanded the pre-emption of all 

state requirements concerning labeling. That Congress added the remainder of the provision is evidence 

of its intent to draw a distinction between state labeling requirements that are pre-empted and those that 

are not.” 544 U. S., at 448–449. 

As with the statutory interpretation rejected by this Court

in Bates, the majority’s interpretation of §22(b)(1) functionally excises 13 words out of the statute, including the

key term “unavoidable.” See Duncan v. Walker, 533 U. S. 

167, 174 (2001) (“We are especially unwilling” to treat a 

statutory term as surplusage “when the term occupies so 

pivotal a place in the statutory scheme”). Although the

resulting “amputated version” of the statutory provision 

“would no doubt have clearly and succinctly commanded

the pre-emption of all state” design defect claims, the fact

“[t]hat Congress added the remainder of the provision” is 

strong evidence of its intent not to pre-empt design defect

claims categorically. Bates, 544 U. S., at 449; see also 

American Home Prods. Corp. v. Ferrari, 284 Ga. 384, 393, 

668 S. E. 2d 236, 242 (2008) (“‘If Congress had intended to

deprive injured parties of a long available form of compensation, it surely would have expressed that intent more 

clearly’” (quoting Bates, 544 U. S., at 449)), cert. pending, 

No. 08–1120. 

Strikingly, the majority concedes that its interpretation 
Cite as: 562 U. S. ____ (2011) 17 

SOTOMAYOR, J., dissenting 

renders 13 words of the statute entirely superfluous. See 

ante, at 12 (“The intervening passage (‘the injury or death 

resulted from side effects that were unavoidable even 

though’) is unnecessary. True enough”). Nevertheless, the 

majority contends that “the rule against giving a portion of 

text an interpretation which renders it superfluous . . .

applies only if verbosity and prolixity can be eliminated by 

giving the offending passage, or the remainder of the text,

a competing interpretation.” Ibid. According to the majority, petitioners’ reading of §22(b)(1) renders the “even 

though” clause superfluous because, to reach petitioners’ 

desired outcome, “[i]t would suffice to say ‘if the injury or 

death resulted from side effects that were unavoidable’— 

full stop.” Ibid. As explained above, however, the “even

though” clause establishes two additional prerequisites—

proper manufacturing and proper labeling—to qualify for 

§22(b)(1)’s exemption from liability. Contrary to the majority’s contention, then, the “even though” clause serves 

an important function by limiting the scope of the preemption afforded by the preceding “if” clause.14 

The majority’s only other textual argument is based on 

—————— 

14 In this manner, the “even though” clause functions in a “concessive

subordinat[ing]” fashion, ante, at 11, in accord with normal grammatical usage. According to the majority, however, the “even though” clause 

“clarifies the word that precedes it” by “delineat[ing]” the conditions

that make a side effect “unavoidable” under the statute. Ante, at 7. 

The majority’s interpretation hardly treats the clause as “concessive,” 

and indeed strains the meaning of “even though.” In the majority’s 

view, proper manufacturing and labeling are the sole prerequisites that 

render a vaccine’s side effects unavoidable. Thus, an injurious side 

effect is unavoidable because the vaccine was properly prepared and

labeled, not “even though” it was. The two conjunctions are not equivalent: The sentence “I am happy even though it is raining” can hardly be 

read to mean that “I am happy because it is raining.” In any event, the 

more fundamental point is that petitioners’ interpretation actually

gives meaning to the words “even though,” whereas the majority

concedes that its interpretation effectively reads those words entirely 

out of the statute. See supra this page. 
18 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

the expressio unius, exclusio alterius canon. According to

the majority, because blackletter products liability law 

generally recognizes three different types of product defects, “[i]f all three were intended to be preserved, it would 

be strange [for Congress] to mention specifically only 

two”—namely, manufacturing and labeling defects in the

“even though” clause—“and leave the third to implication.” 

Ante, at 8. The majority’s argument, however, ignores 

that the default rule under the Vaccine Act is that state 

law is preserved. As explained above, §22(a) expressly 

provides that the “[g]eneral rule” is that “State law shall 

apply to a civil action brought for damages for a vaccinerelated injury or death.” 42 U. S. C. §300aa–22(a). Because §22(a) already preserves state-law design defect 

claims (to the extent the exemption in §22(b)(1) does not 

apply), there was no need for Congress separately and

expressly to preserve design defect claims in §22(b)(1). 

Indeed, Congress’ principal aim in enacting §22(b)(1) was

not to preserve manufacturing and labeling claims (those, 

too, were already preserved by §22(a)), but rather, to

federalize comment k-type protection for “unavoidably 

unsafe” vaccines. The “even though” clause simply functions to limit the applicability of that defense. The lack of 

express language in §22(b)(1) specifically preserving design defect claims thus cannot fairly be understood as

impliedly (and categorically) pre-empting such traditional 

state tort claims, which had already been preserved by

§22(a).15 

—————— 

15This Court, moreover, has long operated on “the assumption that 

the historic police powers of the States are not to be superseded by the 

Federal Act unless that was the clear and manifest purpose of Congress.” Altria Group, Inc. v. Good, 555 U. S. ___, ___ (2008) (slip op., at

5) (internal quotation marks and alteration omitted). Given the long

history of state regulation of vaccines, see Brief for Petitioners 3–6, the

presumption provides an additional reason not to read §22(b)(1) as preempting all design defect claims, especially given Congress’ inclusion of 
Cite as: 562 U. S. ____ (2011) 19 

SOTOMAYOR, J., dissenting 

The majority also suggests that if Congress wished to

preserve design defect claims, it could have simply provided that manufacturers would be liable for “defective 

manufacture, defective directions or warning, and defective design.” Ante, at 8 (internal quotation marks omitted). Putting aside the fact that §22(a) already preserves 

design defect claims (to the extent §22(b)(1) does not apply), the majority’s proposed solution would not have fully

effectuated Congress’ intent. As the legislative history 

makes clear, Congress used the term “unavoidable” to 

effectuate its intent that the “principle in Comment K 

regarding ‘unavoidably unsafe’ products . . . apply to the 

vaccines covered in the bill.” 1986 Report 26; see also 

1987 Report 691. At the time of the Vaccine Act’s enactment in 1986, at least one State had expressly rejected 

comment k,16 while many others had not addressed the

applicability of comment k specifically to vaccines or applied comment k to civil actions proceeding on a theory 

other than strict liability (e.g., negligence17). A statute 

—————— 

an express saving clause in the same statutory section, see 42 U. S. C.

§300aa–22(a), and its use of the conditional “if” clause in defining the

pre-emptive scope of the provision. See Bates v. Dow Agrosciences LLC, 

544 U. S. 431, 449 (2005) (“In areas of traditional state regulation, we 

assume that a federal statute has not supplanted state law unless

Congress has made such an intention clear and manifest” (internal 

quotation marks omitted)). 16See Collins v. Eli Lilly Co., 116 Wis. 2d 166, 197, 342 N. W. 2d 37, 

52 (1984) (“We conclude that the rule embodied in comment k is too 

restrictive and, therefore, not commensurate with strict products 

liability law in Wisconsin”). Collins did, however, “recognize that in

some exigent circumstances it may be necessary to place a drug on the

market before adequate testing can be done.” Ibid. It thus adopted a 

narrower defense (based on “exigent circumstances”) than that recognized in other jurisdictions that had expressly adopted comment k. 17See, e.g., Kearl, 172 Cal. App. 3d, at 831, n. 15, 218 Cal. Rptr., at 

465, n. 15 (“[T]he unavoidably dangerous product doctrine merely

exempts the product from a strict liability design defect analysis; a 

plaintiff remains free to pursue his design defect theory on the basis of 
20 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

that simply stated that vaccine manufacturers would be 

liable for “defective design” would be silent as to the availability of a comment k-type defense for “unavoidably 

unsafe” vaccines, and thus would not have fully achieved 

Congress’ aim of extending greater liability protection 

to vaccine manufacturers by providing comment k-type

protection in all civil actions as a matter of federal law. 

B 

The majority’s structural arguments fare no better than

its textual ones. The principal thrust of the majority’s

position is that, since nothing in the Vaccine Act or the

FDA’s regulations governing vaccines expressly mentions 

design defects, Congress must have intended to remove

issues concerning the design of FDA-licensed vaccines 

from the tort system. Ante, at 13. The flaw in that reasoning, of course, is that the FDA’s silence on design defects existed long before the Vaccine Act was enacted.

Indeed, the majority itself concedes that the “FDA has 

never even spelled out in regulations the criteria it uses to

decide whether a vaccine is safe and effective for its intended use.”18 Ibid. And yet it is undisputed that prior to

the Act, vaccine manufacturers had long been subject to 

liability under state tort law for defective vaccine design. 

That the Vaccine Act did not itself set forth a comprehensive regulatory scheme with respect to design defects is

thus best understood to mean not that Congress suddenly 

decided to change course sub silentio and pre-empt a 

—————— 

negligence”); Toner, 112 Idaho, at 340, 732 P. 2d, at 309–310 (“The

authorities universally agree that where a product is deemed unavoidably unsafe, the plaintiff is deprived of the advantage of a strict liability cause of action, but may proceed under a negligence cause of action”). 18See 42 U. S. C. §262(a)(2)(C)(i)(I) (“The Secretary shall approve a

biologics license application . . . on the basis of a demonstration that . . . 

the biological product that is the subject of the application is safe, pure, 

and potent”). 
Cite as: 562 U. S. ____ (2011) 21 

SOTOMAYOR, J., dissenting 

longstanding, traditional category of state tort law, but 

rather, that Congress intended to leave the status quo

alone (except, of course, with respect to those aspects of

state tort law that the Act expressly altered). See 1987 

Report 691 (“It is not the Committee’s intention to preclude court actions under applicable law. The Committee’s intent at the time of considering the Act . . . was . . .

to leave otherwise applicable law unaffected, except as

expressly altered by the Act”). 

The majority also suggests that Congress necessarily

intended to pre-empt design defect claims since the aim of 

such tort suits is to promote the development of improved

designs and provide compensation for injured individuals, 

and the Vaccine Act “provides other means for achieving 

both effects”—most notably through the no-fault compensation program and the National Vaccine Program. Ante, 

at 14, and nn. 57–60 (citing 42 U. S. C. §§300aa–1, 300aa–

2(a)(1)–(3), 300aa–3, 300aa–25(b), 300aa–27(a)(1)). But 

the majority’s position elides a significant difference between state tort law and the federal regulatory scheme.

Although the Vaccine Act charges the Secretary of Health 

and Human Services with the obligation to “promote the 

development of childhood vaccines” and “make or assure

improvements in . . . vaccines, and research on vaccines,” 

§300aa–27(a), neither the Act nor any other provision of 

federal law places a legal duty on vaccine manufacturers 

to improve the design of their vaccines to account for 

scientific and technological advances. Indeed, the FDA 

does not condition approval of a vaccine on it being the

most optimally designed among reasonably available

alternatives, nor does it (or any other federal entity) ensure that licensed vaccines keep pace with technological 

and scientific advances.19 Rather, the function of ensuring 

—————— 

19See, e.g., Hurley v. Lederle Labs., 863 F. 2d 1173, 1177 (CA5 1988) 

(“[T]he FDA is a passive agency: it considers whether to approve 
22 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

that vaccines are optimally designed in light of existing 

science and technology has traditionally been left to the

States through the imposition of damages for design defects. Cf. Bates, 544 U. S., at 451 (“‘[T]he specter of damage actions may provide manufacturers with added dynamic incentives to continue to keep abreast of all possible

injuries stemming from use of their product[s] so as to 

forestall such actions through product improvement’”); 

Wyeth v. Levine, 555 U. S. ___, ___ (2009) (slip op., at 22– 

—————— 

vaccine designs only if and when manufacturers come forward with a 

proposal”); Jones v. Lederle Labs., 695 F. Supp. 700, 711 (EDNY 1988)

(“[T]he agency takes the drugs and manufacturers as it finds them.

While its goal is to oversee inoculation with the best possible vaccine, it

is limited to reviewing only those drugs submitted by various manufacturers, regardless of their flaws”). Although the FDA has authority 

under existing regulations to revoke a manufacturer’s biologics licenses,

that authority can be exercised only where (as relevant here) “[t]he

licensed product is not safe and effective for all of its intended uses.” 21 

CFR §601.5(b)(1)(vi) (2010); see §600.3(p) (defining “safety” as “relative

freedom from harmful effect to persons affected, directly or indirectly,

by a product when prudently administered, taking into consideration 

the character of the product in relation to the condition of the recipient 

at the time”). The regulation does not authorize the FDA to revoke a

biologics license for a manufacturer’s failure to adopt an optimal

vaccine design in light of existing science and technology. See Conk, Is 

There a Design Defect in the Restatement (Third) of Torts: Products 

Liability? 109 Yale L. J. 1087, 1128–1129 (1999–2000) (“The FDA does

not claim to review products for optimal design . . . . FDA review thus 

asks less of drug . . . manufacturers than the common law of products

liability asks of other kinds of manufacturers”). At oral argument,

counsel for amicus United States stated that the Centers for Disease 

Control and Prevention (CDC) routinely performs comparative analyses 

of vaccines that are already on the market. See Tr. of Oral Arg. 44–45; 

id., at 52–53 (describing CDC’s comparison of Sabin and Salk polio 

vaccines). Neither the United States nor any of the parties, however, 

has represented that CDC examines whether a safer alternative 

vaccine could have been designed given practical and scientific limits,

the central inquiry in a state tort law action for design defect. CDC 

does not issue biologics licenses, moreover, and thus has no authority to

require a manufacturer to adopt a different vaccine design. 
Cite as: 562 U. S. ____ (2011) 23 

SOTOMAYOR, J., dissenting 

23) (noting that the FDA has “traditionally regarded state

law as a complementary form of drug regulation” as

“[s]tate tort suits uncover unknown drug hazards and 

provide incentives for drug manufacturers to disclose 

safety risks promptly”).20 The importance of the States’ 

traditional regulatory role is only underscored by the 

unique features of the vaccine market, in which there are 

“only one or two manufacturers for a majority of the vaccines listed on the routine childhood immunization schedule.” Brief for Respondent 55. The normal competitive

forces that spur innovation and improvements to existing 

product lines in other markets thus operate with less force

in the vaccine market, particularly for vaccines that have 

already been released and marketed to the public. Absent 

a clear statutory mandate to the contrary, there is no 

reason to think that Congress intended in the vaccine 

context to eliminate the traditional incentive and deterrence functions served by state tort liability in favor of a 

federal regulatory scheme providing only carrots and no 

sticks.21 See Levine, 555 U. S., at ___ (slip op., at 18) (“The 

—————— 

20 Indeed, we observed in Levine that the FDA is perpetually understaffed and underfunded, see 555 U. S., at ___, n. 11 (slip op., at 22,

n. 11), and the agency has been criticized in the past for its slow response in failing to withdraw or warn about potentially dangerous 

products, see, e.g., L. Leveton, H. Sox, & M. Soto, Institute of Medicine, 

HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 

(1995) (criticizing FDA response to transmission of AIDS through blood 

supply). These practical shortcomings reinforce the conclusion that

“state law offers an additional, and important, layer of consumer 

protection that complements FDA regulation.” Levine, 555 U. S., at ___ 

(slip op., at 23). 

21The majority mischaracterizes my position as expressing a general 

“skeptic[ism] of preemption unless the congressional substitute operate[s] like the tort system.” Ante, at 16. Congress could, of course, 

adopt a regulatory regime that operates differently from state tort 

systems, and such a difference is not necessarily a reason to question

Congress’ pre-emptive intent. In the specific context of the Vaccine Act,

however, the relevant point is that this Court should not lightly assume 
24 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

case for federal pre-emption is particularly weak where

Congress has indicated its awareness of the operation of 

state law in a field of federal interest, and has nonetheless 

decided to stand by both concepts and to tolerate whatever

tension there is between them.” (internal quotation marks 

and alteration omitted)). 

III 

In enacting the Vaccine Act, Congress established a 

carefully wrought federal scheme that balances the competing interests of vaccine-injured persons and vaccine

manufacturers. As the legislative history indicates, the

Act addressed “two overriding concerns”: “(a) the inadequacy—from both the perspective of vaccine-injured persons as well as vaccine manufacturers—of the current 

approach to compensating those who have been damaged 

by a vaccine; and (b) the instability and unpredictability of 

the childhood vaccine market.” 1986 Report 7. When 

viewed in the context of the Vaccine Act as a whole, 

§22(b)(1) is just one part of a broader statutory scheme

that balances the need for compensating vaccine-injured

children with added liability protections for vaccine manufacturers to ensure a stable childhood vaccine market. 

The principal innovation of the Act was the creation of

the no-fault compensation program—a scheme funded 

entirely through an excise tax on vaccines.22 Through that 

—————— 

that Congress intended sub silentio to displace a longstanding species 

of state tort liability where, as here, Congress specifically included an

express saving clause preserving state law, there is a long history of

state-law regulation of vaccine design, and pre-emption of state law

would leave an important regulatory function—i.e., ensuring optimal

vaccine design—entirely unaddressed by the congressional substitute. 22The majority’s suggestion that “vaccine manufacturers fund from 

their sales” the compensation program is misleading. Ante, at 15. 

Although the manufacturers nominally pay the tax, the amount of the 

tax is specifically included in the vaccine price charged to purchasers. 

See CDC Vaccine Price List (Feb. 15, 2011), http://www.cdc.gov/ 
Cite as: 562 U. S. ____ (2011) 25 

SOTOMAYOR, J., dissenting 

program, Congress relieved vaccine manufacturers of the

burden of compensating victims of vaccine-related injuries

in the vast majority of cases23—an extremely significant 

economic benefit that “functionally creat[es] a valuable 

insurance policy for vaccine-related injuries.” Reply Brief

for Petitioners 10. The structure and legislative history,

moreover, point clearly to Congress’ intention to divert

would-be tort claimants into the compensation program,

rather than eliminate a longstanding category of traditional tort claims. See 1986 Report 13 (“The Committee 

anticipates that the speed of the compensation program, 

the low transaction costs of the system, the no-fault nature of the required findings, and the relative certainty

and generosity of the system’s awards will divert a significant number of potential plaintiffs from litigation”). Indeed, although complete pre-emption of tort claims would 

have eliminated the principal source of the “unpredictability” in the vaccine market, Congress specifically chose not 

to pre-empt state tort claims categorically. See 42 U. S. C. 

§300aa–22(a) (providing as a “[g]eneral rule” that “State

law shall apply to a civil action brought for damages for a

vaccine-related injury or death”). That decision reflects 

Congress’ recognition that court actions are essential 

—————— 

vaccines/programs/vfc/cdc-vac-price-list.htm. Accordingly, the only way 

the vaccine manufacturers can be said to actually “fund” the compensation program is if the cost of the excise tax has an impact on the number of vaccines sold by the vaccine manufacturer. The majority points 

to no evidence that the excise tax—which ordinarily amounts to 75

cents per dose, 26 U. S. C. §4131(b)—has any impact whatsoever on the

demand for vaccines. 23See Brief for United States as Amicus Curiae 28 (“Department of

Justice records indicate that 99.8% of successful Compensation Program claimants have accepted their awards, foregoing any tort remedies against vaccine manufacturers”); S. Plotkin, W. Orenstein, & P. 

Offit, Vaccines 1673 (5th ed. 2008) (noting that “[v]irtually all . . . 

petitioners, even those who were not awarded compensation” under the

compensation program, choose to accept the program’s determination). 
26 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

because they provide injured persons with significant

procedural tools—including, most importantly, civil discovery—that are not available in administrative proceedings under the compensation program. See §§300aa– 

12(d)(2)(E), (d)(3). Congress thus clearly believed there

was still an important function to be played by state tort 

law. 

Instead of eliminating design defect liability entirely, 

Congress enacted numerous measures to reduce manufacturers’ liability exposure, including a limited regulatory 

compliance presumption of adequate warnings, see 

§300aa–22(b)(2), elimination of claims based on failure

to provide direct warnings to patients, §300aa–22(c), a 

heightened standard for punitive damages, §300aa–

23(d)(2), and, of course, immunity from damages for “unavoidable” side effects, §300aa–22(b)(1). Considered in 

light of the Vaccine Act as a whole, §22(b)(1)’s exemption

from liability for unavoidably unsafe vaccines is just one 

part of a broader statutory scheme that reflects Congress’ 

careful balance between providing adequate compensation

for vaccine-injured children and conferring substantial

benefits on vaccine manufacturers to ensure a stable and 

predictable childhood vaccine supply.

The majority’s decision today disturbs that careful

balance based on a bare policy preference that it is better 

“to leave complex epidemiological judgments about vaccine

design to the FDA and the National Vaccine Program

rather than juries.” Ante, at 15.24 To be sure, reasonable 

minds can disagree about the wisdom of having juries 

weigh the relative costs and benefits of a particular vaccine design. But whatever the merits of the majority’s 

—————— 

24 JUSTICE BREYER’s separate concurrence is even more explicitly

policy driven, reflecting his own preference for the “more expert judgment” of federal agencies over the “less expert” judgment of juries. 

Ante, at 5. 
Cite as: 562 U. S. ____ (2011) 27 

SOTOMAYOR, J., dissenting 

policy preference, the decision to bar all design defect 

claims against vaccine manufacturers is one that Congress 

must make, not this Court.25 By construing §22(b)(1) to 

—————— 

25Respondent notes that there are some 5,000 petitions alleging a

causal link between certain vaccines and autism spectrum disorders

that are currently pending in an omnibus proceeding in the Court of 

Federal Claims (Vaccine Court). Brief for Respondent 56–57. According to respondent, a ruling that §22(b)(1) does not pre-empt design 

defect claims could unleash a “crushing wave” of tort litigation that 

would bankrupt vaccine manufacturers and deplete vaccine supply. 

Id., at 28. This concern underlies many of the policy arguments in

respondent’s brief and appears to underlie the majority and concurring 

opinions in this case. In the absence of any empirical data, however,

the prospect of an onslaught of autism-related tort litigation by claimants denied relief by the Vaccine Court seems wholly speculative. As 

an initial matter, the special masters in the autism cases have thus far

uniformly rejected the alleged causal link between vaccines and autism.

See Brief for American Academy of Pediatrics et al. as Amici Curiae 

20–21, n. 4 (collecting cases). To be sure, those rulings do not necessarily mean that no such causal link exists, cf. Brief for United States as 

Amicus Curiae 29 (noting that injuries have been added to the Vaccine 

Injury Table for existing vaccines), or that claimants will not ultimately

be able to prove such a link in a state tort action, particularly with the 

added tool of civil discovery. But these rulings do highlight the substantial hurdles to recovery a claimant faces. See Schafer v. American 

Cyanamid Co., 20 F. 3d 1, 5 (CA1 1994) (“[A] petitioner to whom the 

Vaccine Court gives nothing may see no point in trying to overcome tort

law’s yet more serious obstacles to recovery”). Trial courts, moreover, 

have considerable experience in efficiently handling and disposing of

meritless products liability claims, and decades of tort litigation (including for design defect) in the prescription-drug context have not led 

to shortages in prescription drugs. Despite the doomsday predictions of 

respondent and the various amici cited by the concurrence, ante, at 6–7, 

the possibility of a torrent of meritless lawsuits bankrupting manufacturers and causing vaccine shortages seems remote at best. More 

fundamentally, whatever the merits of these policy arguments, the

issue in this case is what Congress has decided, and as to that question,

the text, structure, and legislative history compel the conclusion that 

Congress intended to leave the courthouse doors open for children who

have suffered severe injuries from defectively designed vaccines. The 

majority’s policy-driven decision to the contrary usurps Congress’ role 

and deprives such vaccine-injured children of a key remedy that Congress intended them to have. 
28 BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

pre-empt all design defect claims against vaccine manufacturers for covered vaccines, the majority’s decision 

leaves a regulatory vacuum in which no one—neither the 

FDA nor any other federal agency, nor state and federal

juries—ensures that vaccine manufacturers adequately 

take account of scientific and technological advancements. 

This concern is especially acute with respect to vaccines 

that have already been released and marketed to the 

public. Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no 

incentive to improve the designs of vaccines that are already generating significant profit margins. Nothing in

the text, structure, or legislative history remotely suggests

that Congress intended that result. 

I respectfully dissent.