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.