Bruesewitz v. Wyeth LLC

(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) cre

ated 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 le

gitimate vaccine-inflicted injuries too costly and difficult. The Act

provides that a party alleging a vaccine-related injury may file a peti

tion 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 pro

tections. 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 af

ter 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, al

leging, 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 com

mon law. Wyeth removed the suit to the Federal District Court. It

granted Wyeth summary judgment, holding that the relevant Penn

sylvania 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 ac

tion for damages arising from a vaccine-related injury or death asso

ciated 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 manufac

ture and warning) with respect to the particular design. This conclu

sion is supported by the fact that, although products-liability law es

tablishes 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 incorporat

ing Restatement (Second) of Torts §402A, Comment k, which exempts

from strict liability rules “unavoidably unsafe products.” “Unavoid

able” 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 in

juries 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’ com

peting 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 Admini

stration regulations that pervasively regulate the drug manufactur

ing 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 men

tioned in the Act, strongly suggests that design defects were not men

tioned because they are not a basis for liability. The Act’s mandates

lead to the same conclusion. It provides for federal agency improve

ment of vaccine design and for federally prescribed compensation,

which are other means for achieving the two beneficial effects of de

sign-defect torts—prompting the development of improved designs,

and providing compensation for inflicted injuries. The Act’s struc

tural 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 de

fect virtually unaltered, would hardly coax them back into the mar

ket. 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 considera

tion 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, Wash

ington, 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 42U. S. C. §300aa–22(b)(1).

2 See P. Hutt, R. Merrill, & L. Grossman, Food and Drug Law 912–

913, 1458 (3d ed. 2007).

3 Centers 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 dis

eases 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 de

lays. 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 manufactur

ers, 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 with

draw; and the remaining manufacturer, Lederle Laborato

ries, 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

——————

4 See Mortimer, Immunization Against Infectious Disease, 200 Sci

ence 902, 906 (1978).

5 See National Vaccine Advisory Committee, A Comprehensive Re

view 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).

6 See 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).

7 See id., at 52.

8 See Centers for Disease Control, Diptheria-Tetanus-Pertussis Vac

cine Shortage, 33 Morbidity and Mortality Weekly Report 695–696

(Dec. 14, 1984).

9 See 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 com

pensation threatened to depress vaccination rates even

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

officials, since vaccines are effective in preventing out

breaks of disease only if a large percentage of the popula

tion is vaccinated.12

To stabilize the vaccine market and facilitate compensa

tion, Congress enacted the NCVIA in 1986. The Act estab

lishes 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 per

son 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 simi

larly 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).

10 Mortimer, supra, at 906.

11 See Hagan, 45 Food Drug Cosm. L. J. 477, 479 (1990).

12 See R. Merrill, Introduction to Epidemiology 65–68 (2010).

13 See 42 U. S. C. §300aa–11(a)(1).

14 See §300aa–12(d)(3).

15 See §300aa–12(e), (g).

16 See §300aa–21(a).

4 BRUESEWITZ v. WYETH LLC

Opinion of the Court

adverse side effects; and indicates how soon after vaccina

tion those side effects should first manifest themselves.17

Claimants who show that a listed injury first manifested

itself at the appropriate time are prima facie entitled to

compensation.18 No showing of 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 de

signed.

Successful claimants receive compensation for medical,

rehabilitation, counseling, special education, and voca

tional training expenses; diminished earning capacity;

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

deaths.21 Attorney’s fees are provided, not only for suc

cessful 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 tort

liability protections for vaccine manufacturers. The Act

requires claimants to seek relief through the compensation

program before filing suit for more than $1,000.24 Manu

facturers are generally immunized from liability for fail

——————

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

Table).

18 See 42 U. S. C. §§300aa–11(c)(1), 300aa–13(a)(1)(A).

19 See §300aa–13(a)(1)(B).

20 See §300aa–11(c)(1)(C)(ii).

21 See §300aa–15(a).

22 See §300aa–15(e).

23 See §300aa–15(i)(2); 26 U. S. C. §§4131, 9510.

24 See 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 re

quirements) and have given the warning either to the

claimant or the claimant’s physician.25 They are immu

nized from liability for punitive damages absent failure to

comply with regulatory requirements, “fraud,” “intentional

and wrongful withholding of information,” or other “crimi

nal 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 ac

tion for damages arising from a vaccine-related injury

or death associated with the administration of a vac

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

sulted from side effects that were unavoidable even

though the vaccine was properly prepared and was ac

companied by proper directions and warnings.”27

B

The vaccine at issue here is a DTP vaccine manufac

tured 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 ac

cording to the Center for Disease Control’s recommended

childhood immunization schedule. Within 24 hours of her

April 1992 vaccination, Hannah started to experience

——————

25 See §300aa–22(b)(2), (c). The immunity does not apply if the plain

tiff establishes by clear and convincing evidence that the manufacturer

was negligent, or was guilty of fraud, intentional and wrongful with

holding 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).

——————

28 See 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).

30 See id., at *1.

31 See 561 F. 3d at 237. The complaint also made claims based upon

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

issue.

32 See 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 ac

tion for damages arising from a vaccine-related injury

or death associated with the administration of a vac

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

sulted from side effects that were unavoidable even

though the vaccine was properly prepared and was ac

companied by proper 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 con

sidered “unavoidable” under the statute. Provided that

there was proper manufacture and warning, any remain

ing 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 un

avoidability (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 42U. S. C. §300aa–22(b)(1).

35 The 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 conclu

sion. 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 pre

served, it would be strange to mention specifically only

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

been much easier (and much more natural) to provide 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.” Barn

hart v. Peabody Coal Co., 537 U. S. 149, 168 (2003). Ex

pressio 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 vac

cine’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 un

avoidable” “plainly implies that some side effects stem

ming 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 proba

bly have no real-world effect.

36 W. 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 “unavoid

able” 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 un

avoidable). Under the latter view, the condition estab

lished 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 manufac

tured. 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 com

ment 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 dan

gerous 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.

39 See Brief for Petitioners 29.

40 Restatement §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).

42 See, 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 Memo

rial 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 label

ing 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

——————

43 The 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 acci

dent, and leaves open two unstated possibilities: (1) that other, un

stated 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.)

44 See W. Follett, Modern American Usage: A Guide 61 (1966).

45 Post, at 9, 17.

46 Post, at 3–5.

47 The 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 elimi

nate “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 interpreta

tion 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 accom

panied by proper directions and warnings.” The interven

ing 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 pre

scribe that a passage which could have been more terse

does not mean what it says. The rule applies only if ver

bosity and prolixity can be eliminated by giving the offend

ing 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 inde

pendent 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.

48 Because the dissent has a superfluity problem of its own, its reli

ance on Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), is mis

placed. See id., at 449 (adopting an interpretation that was “the only

one that makes sense of each phrase” in the relevant statute).

49 That 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) sug

gests. A vaccine’s license spells out the manufacturing

method that must be followed and the directions and

warnings that must accompany the product.50 Manufac

turers ordinarily must obtain the Food and Drug Admini

stration’s (FDA) approval before modifying either.51 De

viations 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 manufac

turer its regulatory-compliance defense.54

Design defects, in contrast, do not merit a single men

tion 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

——————

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

51 See §601.12.

52 See §§211.1 et seq., 600.10–600.15, 600.21–600.22, 820.1 et seq.

53 See §§211.46, 211.48.

54 See 42 U. S. C. §300aa–22(b)(2).

55 Hutt, 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 uni

verse of alternative designs to be limited only by an ex

pert’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 exten-

sive 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 pro

vides 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 re

search, and to coordinate federal vaccine safety and effi

——————

56 See 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 regard

ing 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 Na

tional 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 pro

gram 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

——————

59 See §§300aa–2(a)(1)–(3), 300aa–3.

60 See §300aa–25(b).

61 See NVAC 18–19.

62 See 21 CFR §601.5(b)(1)(vi) (2010).

63 The 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.

64 See 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.

65 See 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 sugges

tion. 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 preemp

tion 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 under

stood” 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

——————

66 See post, at 21–24.

67 H.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 Com

ment k is appropriate and necessary as the policy for civil

actions seeking damages in tort.”70 The dissent’s interpre

tation 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 legisla

tive 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 compen

sation 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 interpre

tation.72 Post-enactment legislative history (a contradic

tion in terms) is not a legitimate tool of statutory interpre

tation. 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 defini

tion “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 syllo

gism: 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 “un

avoidably unsafe”; many others thought it categorically

exempted certain types of products from strict liability.77

——————

73 Pub. L. 99–960, §323(a), 100 Stat. 3784.

74 H. R. Rep. No. 100–391, pt. 1, p. 701 (1987).

75 See, 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.

77 See 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 judg

ment) (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 plain

tiffs 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 “authori

tative” account of Congress’ intent in drafting the pre

emption 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” vaccine

injured persons

“cannot demonstrate under applicable law either that

a vaccine was improperly prepared or that it was ac

companied 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 manu

facturing 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 sys

tem, not the tort system.” Ibid.

The strongest contrary argument rests upon the Re

port’s earlier description of the statute as “set[ting] forth

the principle contained in Comment k” (of the Restate

ment 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 “un

avoidable” 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 de

fects. 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 manufac

turers 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, Re

thinking Conscious Design Liability for Prescription

Drugs: The Restatement (Third) Standard Versus a Negli

gence Approach, 63 Geo. Wash. L. Rev. 76, 79 (1994–1995)

(“[C]ourts [had] adopted a broad range of conflicting inter

pretations” 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 gen

erally 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 vacci

nation 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 whoop

ing 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); Prevent

ing Tetanus, Diphtheria, and Pertussis Among Adoles

cents: Use of Tetanus Toxoid, Reduced Diptheria Toxoid

and Acellular Pertussis Vaccines, 55 Morbidity and Mor

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

inafter Preventing Tetanus) (statistics for 1934–1943),

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

of Health and Human Services, Centers for Disease Con

trol 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) (here

inafter 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 Hear

ings) (testimony of the American Academy of Pediatrics);

see California Dept. of Public Health, Pertussis Re-

port (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 pro

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

ings 20–21; see Gangarosa et al., Impact of Anti-Vaccine

Movements on Pertussis Control: The Untold Story, 351

Lancet 356–361 (Jan. 31, 1998) (when vaccination pro

grams are disrupted, the number of cases of whooping

cough skyrockets, 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 dis

eases.” 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 compensa

tion program. Id., at 5, 24.

Given these broad general purposes, to read the pre

emption 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 In-

jury Table. 42 U. S. C. §300aa–14; ante, at 3–4; A

Comprehensive Review of Federal Vaccine Safety Pro

grams 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 second

guess those determinations is to substitute less expert for

more expert judgment, thereby threatening manufacturers

with liability (indeed, strict liability) in instances where

any conflict between experts and 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 re

sulting 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 with

drawal 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 Acad

emy of Pediatrics, the American Academy of Family Phy

sicians, the American College of Preventive Medicine, the

American Public Health Association, the American Medi

cal Association, the March of Dimes Foundation, the Pedi

atric Infectious Diseases Society, and 15 other similar

organizations. Brief for American Academy of Pediatrics

et al. as Amici Curiae (hereinafter AAP Brief). The Ameri

can Academy of Pediatrics has also supported the reten

tion 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 un

dermine 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 thor

ough understanding” of the complicated and technical

subject matter of immunization policy, and it is compara

tively more “qualified to comprehend the likely impact of

state requirements.” Geier v. 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 par

ticularly 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, mis

construes 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 ade

quately take account of scientific and technological ad

vancements when designing or distributing their products.

Because nothing in the text, structure, or legislative his

tory 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 ac

tion for damages arising from a vaccine-related injury

or death associated with the administration of a vac

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

sulted from side effects that were unavoidable even

though the vaccine was properly prepared and was

accompanied 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 prop

erly 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 direc

tions 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

——————

1 W. 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 pre

sent. Because §22(b)(1) is invoked by vaccine manufactur

ers 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 ab

sence 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 prod

ucts 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 avoid

able. 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

——————

2 See 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 pre

sumption that, for purposes of §22(b)(1), “a vaccine shall

be presumed to be accompanied by proper directions and

warnings if the vaccine manufacturer shows that it com

plied in all material respects with” federal labeling re

quirements. 42 U. S. C. §300aa–22(b)(2). Similarly, in

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

damages “[i]f . . . the 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 condi

tional “if ” clause in §§22(b)(2) and 23(d)(2) to require a

specific inquiry in each case while using the same condi

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

emption 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 countermea

sure[s],” Congress provided that subject to certain excep

tions, “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’ interpreta

tion 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 prin

ciple contained in Comment K of Section 402A of the

Restatement of Torts (Second) that a vaccine manu

facturer should not be liable for injuries or deaths re

sulting 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

——————

3 This leaves the question of what precisely §22(b)(1) means by “un

avoidable” 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”;

——————

4 Comment 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 pre

scription 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 qualifica

tion 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

——————

5 See, 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 avail

ability . . . of any alternative product that would have as effectively

accomplished the full intended purpose of the subject product”), disap

proved 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 enact

ment 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 co

existence 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 omit

ted)). 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.

6 The 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 Secu

rity, 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’ interpreta

tion 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 “un

avoidable,” 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 par

ticular 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.

7 See, 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 Con

gress 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

——————

8 Respondent 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 im

proper directions or inadequate warnings [they] should pursue recom

pense 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 com

ment 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 under

mined 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 tradi

tional mechanism for such review (i.e., design defect liability), particu

larly 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, Con

gress passed legislation to fund the compensation pro

gram. 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 manu

facturer’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 provi

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

——————

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

whether the 1987 Report was authored by the House Budget Commit

tee 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 Com

mittee Prints approved by the Committee on Energy and Commerce for

inclusion in the forthcoming reconciliation bill.” 1987 Report 377, 380.

10 The 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 com

pensation program, the views of the Congress that enacted

that funding legislation are a proper and, indeed, authori

tative 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 danger

ous precedent.” Ante, at 18. The difference, of course, is that appro

priations 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 reluc

tance to view appropriations legislation as modifying substantive

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

bearing here.

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

proposal).

12 See, 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 par

ticular, 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, Ameri

can 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 compro

mising 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 vio

lence to the statutory text, misconstrues the legislative

history, and draws the wrong conclusions from the struc

ture 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 re

spects. First, the majority’s categorical reading rests on a

faulty and untenable premise. Second, its reading func

tionally excises 13 words from the statutory text, including

the key term “unavoidable.” And third, the majority en

tirely 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, accord

ing to the majority, will always be able to point to a differ

ently designed vaccine not containing the “harmful ele

ment,” and if that were sufficient to show that a vaccine’s

side effects were not “unavoidable,” the statute would pre

empt 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 con

taining 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 con

templated that there would be some instances in which a

vaccine’s side effects are “unavoidable” and other in

stances in which they are not. See supra, at 3. The major

ity’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 ig

nores 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

——————

13 SeeAmerican 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 legisla

tive 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 necessar

ily invalid.

The majority’s reading suffers from an even more fun

damental defect. If Congress intended to exempt vaccine

manufacturers categorically from all design defect liabil

ity, 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. An

drews, 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 (quot

ing 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 [re

spondent] and the United States is any plausible al

ternative 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 require

ments 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 Con

gress added the remainder of the provision is evidence

of its intent to draw a distinction between state label

ing 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) func

tionally 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 compen

sation, 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 major

ity, 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 ma

jority’s contention, then, the “even though” clause serves

an important function by limiting the scope of the pre

emption afforded by the preceding “if ” clause.14

The majority’s only other textual argument is based on

——————

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

subordinat[ing]” fashion, ante, at 11, in accord with normal grammati

cal 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 equiva

lent: 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 de

fects, “[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 vaccine

related injury or death.” 42 U. S. C. §300aa–22(a). Be

cause §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 func

tions to limit the applicability of that defense. The lack of

express language in §22(b)(1) specifically preserving de

sign 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

——————

15 This 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 Con

gress.” 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 pre

empting 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 pro

vided that manufacturers would be liable for “defective

manufacture, defective directions or warning, and defec

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

ted). Putting aside the fact that §22(a) already preserves

design defect claims (to the extent §22(b)(1) does not ap

ply), 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 enact

ment 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 ap

plied 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)).

16 See 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 recog

nized in other jurisdictions that had expressly adopted comment k.

17 See, 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 avail

ability 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 rea

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

fects 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 in

tended 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 comprehen

sive 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 unavoid

ably unsafe, the plaintiff is deprived of the advantage of a strict liabil

ity cause of action, but may proceed under a negligence cause of ac

tion”).

18 See 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 pre

clude court actions under applicable law. The Commit

tee’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 compen

sation 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 be

tween 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) en

sure that licensed vaccines keep pace with technological

and scientific advances.19 Rather, the function of ensuring

——————

19 See, 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 de

fects. Cf. Bates, 544 U. S., at 451 (“ ‘[T]he specter of dam

age actions may provide manufacturers with added dy

namic 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 manufac

turers, 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 vac

cines listed on the routine childhood immunization sched

ule.” 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 deter

rence 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 under

staffed 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 re

sponse 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).

21 The majority mischaracterizes my position as expressing a general

“skeptic[ism] of preemption unless the congressional substitute oper

ate[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 com

peting interests of vaccine-injured persons and vaccine

manufacturers. As the legislative history indicates, the

Act addressed “two overriding concerns”: “(a) the inade

quacy—from both the perspective of vaccine-injured per

sons 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 manu

facturers 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.

22 The 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 tradi

tional 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 na

ture of the required findings, and the relative certainty

and generosity of the system’s awards will divert a signifi

cant number of potential plaintiffs from litigation”). In

deed, although complete pre-emption of tort claims would

have eliminated the principal source of the “unpredictabil

ity” 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 compensa

tion program is if the cost of the excise tax has an impact on the num

ber 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.

23 See Brief for United States as Amicus Curiae 28 (“Department of

Justice records indicate that 99.8% of successful Compensation Pro

gram claimants have accepted their awards, foregoing any tort reme

dies 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 dis

covery—that are not available in administrative proceed

ings under the compensation program. See §§300aa–

12(d)(2)(E), (d)(3). Congress thus clearly believed there

was still an important function to be played by state tort

law.

Instead of eliminating design defect liability entirely,

Congress enacted numerous measures to reduce manufac

turers’ 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 “un

avoidable” 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 vac

cine 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 judg

ment” 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

——————

25 Respondent 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. Accord

ing 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 claim

ants 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 necessar

ily 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 sub

stantial 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 (in

cluding 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 manufac

turers 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 Con

gress intended them to have.

28 BRUESEWITZ v. WYETH LLC

SOTOMAYOR, J., dissenting

pre-empt all design defect claims against vaccine manu

facturers 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 competi

tion in the vaccine market, will often have little or no

incentive to improve the designs of vaccines that are al

ready generating significant profit margins. Nothing in

the text, structure, or legislative history remotely suggests

that Congress intended that result.

I respectfully dissent.