562 U. S. ____ (2011)
562 U. S. ____ (2011)
562 U. S. ____ (2011)
SUPREME COURT OF THE UNITED STATES
NO. 09-152
RUSSELL BRUESEWITZ, et al., PETITIONERS
v. WYETH LLC, fka WYETH, INC., fka WYETH LABORATORIES,
et al.
on writ of certiorari to the united states court of
appeals for the third circuit
[February 22, 2011]
Justice Sotomayor, with whom
Justice Ginsburg joins, dissenting.
Vaccine manufacturers have long
been subject to a legal duty, rooted in basic principles of
products liability law, to improve the designs of their vaccines in
light of advances in science and technology. Until today, that duty
was enforceable through a traditional state-law tort action for
defective design. In holding that §22(b)(1) of the National
Childhood Vaccine Injury Act of 1986 (Vaccine Act or Act), 42 U.
S. C. §300aa–22(b)(1), pre-empts all design defect claims for
injuries stemming from vaccines covered under the Act, the Court
imposes its own bare policy preference over the considered judgment
of Congress. In doing so, the Court excises 13 words from the
statutory text, misconstrues the Act’s legislative history, and
disturbs the careful balance Congress struck between compensating
vaccine-injured children and stabilizing the childhood vaccine
market. Its decision leaves a regulatory vacuum in which no one
ensures that vaccine manufacturers adequately take account of
scientific and technological advancements when designing or
distributing their products. Because nothing in the text,
structure, or legislative history of the Vaccine Act remotely
suggests that Congress intended such a result, I respectfully
dissent.
I
A
Section 22 of the Vaccine Act
provides “[s]tandards of responsibility” to govern civil actions
against vaccine manufacturers. 42 U. S. C. §300aa–22. Section
22(a) sets forth the “[g]eneral rule” that “State law shall apply
to a civil action brought for damages for a vaccine-related injury
or death.” §300aa–22(a). This baseline rule that state law applies
is subject to three narrow exceptions, one of which, §22(b)(1), is
at issue in this case. Section 22(b)(1) provides:
“No vaccine manufacturer shall be liable in a civil
action for damages arising from a vaccine-related injury or death
associated with the administration of a vaccine after October 1,
1988, if the injury or death resulted from side effects that were
unavoidable even though the vaccine was properly prepared and was
accompanied by proper directions and warnings.”
§300aa–22(b)(1).
The provision contains two key clauses: “if the
injury or death resulted from side effects that were unavoidable”
(the “if ” clause), and “even though the vaccine was properly
prepared and was accompanied by proper directions and warnings”
(the “even though” clause).
Blackletter products liability law generally
recognizes three different types of product defects: design
defects, manufacturing defects, and labeling defects
(
e.g., failure to warn).[
Footnote 1] The reference in the “even though” clause to a
“properly prepared” vaccine “accompanied by proper directions and
warnings” is an obvious reference to two such defects—manufacturing
and labeling defects. The plain terms of the “even though” clause
thus indicate that §22(b)(1) applies only where neither kind of
defect is present. Because §22(b)(1) is invoked by vaccine
manufacturers as a defense to tort liability, it follows that the
“even though” clause requires a vaccine manufacturer in each civil
action to demonstrate that its vaccine is free from manufacturing
and labeling defects to fall within the liability exemption of
§22(b)(1).[
Footnote 2]
Given that the “even though” clause requires
the absence of manufacturing and labeling defects, the “if ”
clause’s reference to “side effects that were unavoidable” must
refer to side effects caused by something other than manufacturing
and labeling defects. The only remaining kind of product defect
recognized under traditional products liability law is a design
defect. Thus, “side effects that were unavoidable” must refer to
side effects caused by a vaccine’s
design that were
“unavoidable.” Because §22(b)(1) uses the conditional term “if,”
moreover, the text plainly implies that some side effects stemming
from a vaccine’s design are “unavoidable,” while others are
avoidable. See Webster’s Third New International Dictionary 1124
(2002) (“if ” means “in the event that,” “so long as,” or “on
condition that”). Accordingly, because the “if ” clause (like
the “even though” clause) sets forth a condition to invoke
§22(b)(1)’s defense to tort liability, Congress must also have
intended a vaccine manufacturer to demonstrate in each civil action
that the particular side effects of a vaccine’s design were
“unavoidable.”
Congress’ use of conditional “if ”
clauses in two other provisions of the Vaccine Act supports the
conclusion that §22(b)(1) requires an inquiry in each case in which
a manufacturer seeks to invoke the provision’s exception to state
tort liability. In §22(b)(2), Congress created a presumption that,
for purposes of §22(b)(1), “a vaccine shall be presumed to be
accompanied by proper directions and warnings if the vaccine
manufacturer shows that it complied in all material respects with”
federal labeling requirements. 42 U. S. C. §300aa–22(b)(2).
Similarly, in §23(d)(2), Congress created an exemption from
punitive damages “[i]f . . . the manufacturer shows that it
complied, in all material respects,” with applicable federal laws,
unless it engages in “fraud,” “intentional and wrongful withholding
of information” from federal regulators, or “other criminal or
illegal activity.” §300aa–23(d)(2). It would be highly anomalous
for Congress to use a conditional “if ” clause in §§22(b)(2)
and 23(d)(2) to require a specific inquiry in each case while using
the same conditional “if ” clause in §22(b)(1) to denote a
categorical exemption from liability. Cf.
Erlenbaugh v.
United States,
409 U. S. 239, 243
(1972) (“[A] legislative body generally uses a particular word with
a consistent meaning in a given context”).
Indeed, when Congress intends to pre-empt
design defect claims categorically, it does so using categorical
(
e.g., “all”) and/or declarative language (
e.g.,
“shall”), rather than a conditional term (“if ”). For example,
in a related context, Congress has authorized the Secretary of
Health and Human Services to designate a vaccine designed to
prevent a pandemic or epidemic as a “covered countermeasure.” 42 U.
S. C. §§247d–6d(b), (i)(1), (i)(7)(A)(i). With respect to such
“covered countermeasure[s],” Congress provided that subject to
certain exceptions, “a covered person
shall be immune from
suit and liability under Federal and State law with respect to
all claims for loss caused by, arising out of, relating
to, or resulting from the administration to or the use by an
individual of a covered countermeasure,” §247d–6d(a)(1) (emphasis
added), including specifically claims relating to “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.[
Footnote 3]
B
The legislative history confirms
petitioners’ interpretation of §22(b)(1) and sheds further light on
its pre-emptive scope. The House Energy and Commerce Committee
Report accompanying the Vaccine Act, H. R. Rep. No. 99–908,
pt. 1 (1986) (hereinafter 1986 Report), explains in relevant
part:
“
Subsection (b)—Unavoidable
Adverse Side Effects; Direct Warnings.—This provision sets
forth the principle contained in Comment K of Section 402A of the
Restatement of Torts (Second) that a vaccine manufacturer should
not be liable for injuries or deaths resulting from unavoidable
side effects even though the vaccine was properly prepared and
accompanied by proper directions and warnings.
“The Committee has set forth Comment K in this
bill because it intends that the principle in Comment K regarding
‘unavoidably unsafe’ products, i.e., those products which in the
present state of human skill and knowledge cannot be made safe,
apply to the vaccines 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.[
Footnote 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”; “[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.[
Footnote 5] Given Congress’ expressed intent
to codify the “principle in Comment K,” 1986 Report 26, the term
“unavoidable” in §22(b)(1) is best understood as a term of art,
which incorporates the commonly understood meaning of “unavoidably
unsafe” products under comment
k at the time of the Act’s
enactment in 1986. See
McDermott Int’l, Inc. v.
Wilander,
498 U. S. 337, 342
(1991) (“[W]e assume that when a statute uses … a term [of art],
Congress intended it to have its established meaning”);
Morissette v.
United States,
342 U. S. 246, 263
(1952) (same).[
Footnote 6]
Similarly, courts applying 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.[
Footnote
7] By requiring “prope[r] prepar[ation]” and “proper directions
and warnings” in §22(b)(1), Congress plainly intended to
incorporate these additional comment
k requirements.
The 1986 Report thus confirms petitioners’
interpretation of §22(b)(1). The Report makes clear that “side
effects that were unavoidable” in §22(b)(1) refers to side effects
stemming from a vaccine’s design that were “unavoidable.” By
explaining what Congress meant by the term “unavoidable,” moreover,
the Report also confirms that whether a side effect is
“unavoidable” for purposes of §22(b)(1) involves a specific inquiry
in each case as to whether the vaccine “in the present state of
human skill and knowledge cannot be made safe,” 1986 Report
26—
i.e., whether a feasible alternative design existed
that would have eliminated the adverse side effects of the vaccine
without compromising its cost and utility. See Brief for Kenneth W.
Starr et al. as
Amici Curiae 14–15 (“If a particular
plaintiff could show that her injury at issue was avoidable …
through the use of a feasible alternative design for a specific
vaccine, then she would satisfy the plain language of the statute,
because she would have demonstrated that the side effects were
not unavoidable”). Finally, the Report confirms that the
“even though” clause is properly read to establish two additional
prerequisites—proper manufacturing and proper labeling—to qualify
for §22(b)(1)’s liability exemption.[
Footnote 8]
In addition to the 1986 Report, one other
piece of the Act’s legislative history provides further
confirmation of the petitioners’ textual reading of §22(b)(1). When
Congress enacted the Vaccine Act in 1986, it did not initially
include a source of payment for the no-fault compensation program
the Act established. The Act thus “made the compensation program
and accompanying tort reforms contingent on the enactment of a tax
to provide funding for the compensation.” 1987 Report 690. In 1987,
Congress passed legislation to fund the compensation program. The
House Energy and Commerce Committee Report[
Footnote 9] accompanying that legislation specifically
stated that “the codification of Comment (k) of The Restatement
(Second) of Torts was not intended to decide as a matter of law the
circumstances in which a vaccine should be deemed unavoidably
unsafe.”
Id., at 691. The Committee noted that “[a]n
amendment to establish … that a manufacturer’s failure to develop
[a] safer vaccine was not grounds for liability was rejected by the
Committee during its original consideration of the Act.”
Ibid. In light of that rejection, the Committee emphasized
that “there should be no misunderstanding that the Act undertook to
decide as a matter of law whether vaccines were unavoidably unsafe
or not,” and that “[t]his question is left to the courts to
determine in accordance with applicable law.”
Ibid.
To be sure, postenactment legislative history
created by a subsequent Congress is ordinarily a hazardous basis
from which to infer the intent of the enacting Congress. See
Sullivan v.
Finkelstein,
496 U. S. 617, 631–632
(1990) (Scalia, J., concurring in part). But unlike ordinary
postenactment legislative history, which is justifiably given
little or no weight, the 1987 Report reflects the intent of the
Congress that enacted the funding legislation necessary to give
operative effect to the principal provisions of the Vaccine Act,
including §22(b)(1).[
Footnote
10] Congress in 1987 had a number of options before it,
including adopting an entirely different compensation scheme, as
the Reagan administration was proposing;[
Footnote 11] establishing different limitations on
tort liability, including eliminating design defect liability, as
pharmaceutical industry leaders were advocating;[
Footnote 12] or not funding the
compensation program at all, which would have effectively nullified
the relevant portions of the Act. Because the tort reforms in the
1986 Act, including §22(b)(1), had no operative legal effect unless
and until Congress provided funding for the compensation program,
the views of the Congress that enacted that funding legislation are
a proper and, indeed, authoritative guide to the meaning of
§22(b)(1). Those views, as reflected in the 1987 Report, provide
unequivocal confirmation of petitioners’ reading of §22(b)(1).
In sum, the text, structure, and legislative
history of the Vaccine Act are fully consistent with petitioners’
reading of §22(b)(1). Accordingly, I believe §22(b)(1) exempts
vaccine manufacturers from tort liability only upon a showing by
the manufacturer in each case that the vaccine was properly
manufactured and labeled, and that the side effects stemming from
the vaccine’s design could not have been prevented by a feasible
alternative design that would have eliminated the adverse side
effects without compromising the vaccine’s cost and utility.
II
In contrast to the interpretation
of §22(b)(1) set forth above, the majority’s interpretation does
considerable vio-lence to the statutory text, misconstrues the
legislative history, and draws the wrong conclusions from the
structure of the Vaccine Act and the broader federal scheme
regulating vaccines.
A
As a textual matter, the
majority’s interpretation of §22(b)(1) is fundamentally flawed in
three central respects. First, the majority’s categorical reading
rests on a faulty and untenable premise. Second, its reading
functionally excises 13 words from the statutory text, including
the key term “unavoidable.” And third, the majority entirely
ignores the Vaccine Act’s default rule preserving state tort
law.
To begin, the majority states
that “[a] side effect of a vaccine could
always have been
avoidable by use of a differently designed vaccine not containing
the harmful element.”
Ante, at 7. From that premise, the
majority concludes that the statute must mean that “the
design of the vaccine is a given, not subject to question
in the tort action,” because construing the statute otherwise would
render §22(b)(1) a nullity.
Ibid. A tort claimant,
according to the majority, will always be able to point to a
differently designed vaccine not containing the “harmful element,”
and if that were sufficient to show that a vaccine’s side effects
were not “unavoidable,” the statute would 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 containing
the harmful element,”
ibid., this interpretation of
“unavoidable” would effectively read the term out of the statute,
and Congress could not have intended that result. Indeed, §22(b)(1)
specifically uses the conditional phrase “if the injury or death
resulted from side effects that were unavoidable,” which plainly
indicates that Congress contemplated that there would be some
instances in which a vaccine’s side effects are “unavoidable” and
other instances in which they are not. See
supra, at 3.
The majority’s premise that a vaccine’s side effects can always be
“avoid[ed] by use of a differently designed vaccine not containing
the harmful element,”
ante, at 7, entirely ignores the
fact that removing the “harmful element” will often result in a
less effective (or entirely ineffective) vaccine. A vaccine, by its
nature, ordinarily employs a killed or weakened form of a bacteria
or virus to stimulate antibody production;[
Footnote 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 “unavoidable” for
purposes of §22(b)(1) only where there is no feasible alternative
design that would eliminate the side effect of the vaccine without
compromising its cost and utility. See
supra, at 7. The
majority’s premise—that side effects stemming from a vaccine’s
design are always avoidable—is thus belied by the statutory text
and legislative history of §22(b)(1). And because its starting
premise is invalid, its conclusion—that the design of a vaccine is
not subject to challenge in a tort action—is also necessarily
invalid.
The majority’s reading suffers from an even
more fundamental defect. If Congress intended to exempt vaccine
manufacturers categorically from all design defect liability, it
more logically would have provided: “No vaccine manufacturer shall
be liable in a civil action for damages arising from a
vaccine-related injury or death associated with the administration
of a vaccine after October 1, 1988, if the vaccine was properly
prepared and was accompanied by proper directions and warnings.”
There would have been no need for Congress to include the
additional 13 words “the injury or death resulted from side effects
that were unavoidable even though.” See
TRW Inc. v.
Andrews,
534
U. S. 19, 31 (2001) (noting “cardinal principle of statutory
construction that a statute ought, upon the whole, to be so
construed that, if it can be prevented, no clause, sentence, or
word shall be superfluous, void, or insignificant” (internal
quotation marks omitted)).
In
Bates v.
Dow Agrosciences
LLC,
544 U. S. 431 (2005), this Court
considered an analogous situation where an express pre-emption
provision stated that certain States “ ‘shall not impose or
continue in effect any requirements for labeling or packaging in
addition to or different from those required under this
subchapter.’ ”
Id., at 436 (quoting 7 U. S. C.
§136v(b) (2000 ed.)). The
Bates Court stated:
“Conspicuously absent from the submissions by
[respondent] and the United States is any plausible alternative
interpretation of ‘in addition to or different from’ that would
give that phrase meaning. Instead, they appear to favor reading
those words out of the statute, which would leave the following:
‘Such State shall not impose or continue in effect any requirements
for labeling or packaging.’ This amputated version of [the statute]
would no doubt have clearly and succinctly commanded the
pre-emption of
all state requirements concerning labeling.
That Congress added the remainder of the provision is evidence of
its intent to draw a distinction between state labeling
requirements that are pre-empted and those that are not.” 544 U.
S., at 448–449.
As with the statutory interpretation rejected by
this Court in
Bates, the majority’s interpretation of
§22(b)(1) functionally excises 13 words out of the statute,
including the key term “unavoidable.” See
Duncan v.
Walker,
533
U. S. 167, 174 (2001) (“We are especially unwilling” to treat a
statutory term as surplusage “when the term occupies so pivotal a
place in the statutory scheme”). Although the resulting “amputated
version” of the statutory provision “would no doubt have clearly
and succinctly commanded the pre-emption of
all state”
design defect claims, the fact “[t]hat Congress added the remainder
of the provision” is strong evidence of its intent not to pre-empt
design defect claims categorically.
Bates, 544 U. S., at
449; see also
American Home Prods. Corp. v.
Ferrari, 284 Ga. 384, 393, 668 S. E. 2d 236, 242
(2008) (“ ‘If Congress had intended to deprive injured parties
of a long available form of compensation, it surely would have
expressed that intent more clearly’ ” (quoting
Bates,
544 U. S., at 449)), cert. pending, No. 08–1120.
Strikingly, the majority concedes that its
interpretation renders 13 words of the statute entirely
superfluous. See
ante, at 12 (“The intervening passage
(‘the injury or death resulted from side effects that were
unavoidable even though’) is unnecessary. True enough”).
Nevertheless, the majority contends that “the rule against giving a
portion of text an interpretation which renders it superfluous …
applies only if verbosity and prolixity can be eliminated by giving
the offending passage, or the remainder of the text, a competing
interpretation.”
Ibid. According to the majority,
petitioners’ reading of §22(b)(1) renders the “even though” clause
superfluous because, to reach petitioners’ desired outcome, “[i]t
would suffice to say ‘if the injury or death resulted from side
effects that were unavoidable’—full stop.”
Ibid. As
explained above, however, the “even though” clause establishes two
additional prerequisites—proper manufacturing and proper
labeling—to qualify for §22(b)(1)’s exemption from liability.
Contrary to the majority’s contention, then, the “even though”
clause serves an important function by limiting the scope of the
pre-emption afforded by the preceding “if ” clause.[
Footnote 14]
The majority’s only other textual argument is
based on the
expressio unius,
exclusio alterius
canon. According to the majority, because blackletter products
liability law generally recognizes three different types of product
defects, “[i]f all three were intended to be preserved, it would be
strange [for Congress] to mention specifically only two”—namely,
manufacturing and labeling defects in the “even though” clause—“and
leave the third to implication.”
Ante, at 8. The
majority’s argument, however, ignores that the default rule under
the Vaccine Act is that state law is preserved. As explained above,
§22(a) expressly provides that the “[g]eneral rule” is that “State
law shall apply to a civil action brought for damages for a
vaccine-related injury or death.” 42 U. S. C. §300aa–22(a).
Because §22(a) already preserves state-law design defect claims (to
the extent the exemption in §22(b)(1) does not apply), there was no
need for Congress separately and expressly to preserve design
defect claims in §22(b)(1). Indeed, Congress’ principal aim in
enacting §22(b)(1) was not to preserve manufacturing and labeling
claims (those, too, were already preserved by §22(a)), but rather,
to federalize comment
k-type protection for “unavoidably
unsafe” vaccines. The “even though” clause simply functions to
limit the applicability of that defense. The lack of express
language in §22(b)(1) specifically preserving design defect claims
thus cannot fairly be understood as impliedly (and categorically)
pre-empting such traditional state tort claims, which had already
been preserved by §22(a).[
Footnote 15]
The majority also suggests that if Congress
wished to preserve design defect claims, it could have simply
provided that manufacturers would be liable for “defective
manufacture, defective directions or warning, and defective
design.”
Ante, at 8 (internal quotation marks omitted).
Putting aside the fact that §22(a) already preserves design defect
claims (to the extent §22(b)(1) does not apply), the majority’s
proposed solution would not have fully effectuated Congress’
intent. As the legislative history makes clear, Congress used the
term “unavoidable” to effectuate its intent that the “principle in
Comment K regarding ‘unavoidably unsafe’ products … apply to the
vaccines covered in the bill.” 1986 Report 26; see also 1987 Report
691. At the time of the Vaccine Act’s enactment in 1986, at least
one State had expressly rejected comment
k,[
Footnote 16] while many others had not
addressed the applicability of comment
k specifically to
vaccines or applied comment
k to civil actions proceeding
on a theory other than strict liability (
e.g.,
negligence[
Footnote 17]). A
statute that simply stated that vaccine manufacturers would be
liable for “defective design” would be silent as to the
availability of a comment
k-type defense for “unavoidably
unsafe” vaccines, and thus would not have fully achieved Congress’
aim of extending greater liability protection to vaccine
manufacturers by providing comment
k-type protection in
all civil actions as a matter of federal law.
B
The majority’s structural
arguments fare no better than its textual ones. The principal
thrust of the majority’s position is that, since nothing in the
Vaccine Act or the FDA’s regulations governing vaccines expressly
mentions design defects, Congress must have intended to remove
issues concerning the design of FDA-licensed vaccines from the tort
system.
Ante, at 13. The flaw in that reasoning, of
course, is that the FDA’s silence on design defects existed long
before the Vaccine Act was enacted. Indeed, the majority itself
concedes that the “FDA has never even spelled out in regulations
the criteria it uses to decide whether a vaccine is safe and
effective for its intended use.”[
Footnote 18]
Ibid. And yet it is undisputed that
prior to the Act, vaccine manufacturers had long been subject to
liability under state tort law for defective vaccine design. That
the Vaccine Act did not itself set forth a comprehensive regulatory
scheme with respect to design defects is thus best understood to
mean not that Congress suddenly decided to change course
sub
silentio and pre-empt a longstanding, traditional category of
state tort law, but rather, that Congress intended to leave the
status quo alone (except, of course, with respect to those aspects
of state tort law that the Act expressly altered). See 1987 Report
691 (“It is not the Committee’s intention to preclude court actions
under applicable law. The Committee’s intent at the time of
considering the Act … was … to leave otherwise applicable law
unaffected, except as expressly altered by the Act”).
The majority also suggests that
Congress necessarily intended to pre-empt design defect claims
since the aim of such tort suits is to promote the development of
improved designs and provide compensation for injured individuals,
and the Vaccine Act “provides other means for achieving both
effects”—most notably through the no-fault compensation program and
the National Vaccine Program.
Ante, at 14, and nn. 57–60
(citing 42 U. S. C. §§300aa–1, 300aa–2(a)(1)–(3), 300aa–3,
300aa–25(b), 300aa–27(a)(1)). But the majority’s position elides a
significant difference between state tort law and the federal
regulatory scheme. Although the Vaccine Act charges the Secretary
of Health and Human Services with the obligation to “promote the
development of childhood vaccines” and “make or assure improvements
in . . . vaccines, and research on vaccines,” §300aa–27(a), neither
the Act nor any other provision of federal law places a legal
duty on vaccine manufacturers to improve the design of
their vaccines to account for scientific and technological
advances. Indeed, the FDA does not condition approval of a vaccine
on it being the most optimally designed among reasonably available
alternatives, nor does it (or any other federal entity) ensure that
licensed vaccines keep pace with technological and scientific
advances.[
Footnote 19]
Rather, the function of ensuring that vaccines are optimally
designed in light of existing science and technology has
traditionally been left to the States through the imposition of
damages for design defects. Cf.
Bates, 544 U. S., at 451
(“ ‘[T]he specter of damage actions may provide manufacturers
with added dynamic incentives to continue to keep abreast of all
possible injuries stemming from use of their product[s] so as to
forestall such actions through product improvement’ ”);
Wyeth v.
Levine, 555 U. S. ___, ___ (2009) (slip
op., at 22–23) (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”).[
Footnote 20] The importance of the
States’ traditional regulatory role is only underscored by the
unique features of the vaccine market, in which there are “only one
or two manufacturers for a majority of the vaccines listed on the
routine childhood immunization schedule.” Brief for Respondent 55.
The normal competitive forces that spur innovation and improvements
to existing product lines in other markets thus operate with less
force in the vaccine market, particularly for vaccines that have
already been released and marketed to the public. Absent a clear
statutory mandate to the contrary, there is no reason to think that
Congress intended in the vaccine context to eliminate the
traditional incentive and deterrence functions served by state tort
liability in favor of a federal regulatory scheme providing only
carrots and no sticks.[
Footnote
21] See
Levine, 555 U. S., at ___ (slip op., at 18)
(“The case for federal pre-emption is particularly weak where
Congress has indicated its awareness of the operation of state law
in a field of federal interest, and has nonetheless decided to
stand by both concepts and to tolerate whatever tension there is
between them.” (internal quotation marks and alteration
omitted)).
III
In enacting the Vaccine Act,
Congress established a carefully wrought federal scheme that
balances the competing interests of vaccine-injured persons and
vaccine manufacturers. As the legislative history indicates, the
Act addressed “two overriding concerns”: “(a) the inadequacy—from
both the perspective of vaccine-injured persons as well as vaccine
manufacturers—of the current approach to compensating those who
have been damaged by a vaccine; and (b) the instability and
unpredictability of the childhood vaccine market.” 1986 Report 7.
When viewed in the context of the Vaccine Act as a whole, §22(b)(1)
is just one part of a broader statutory scheme that balances the
need for compensating vaccine-injured children with added liability
protections for vaccine manufacturers to ensure a stable childhood
vaccine market.
The principal innovation of the
Act was the creation of the no-fault compensation program—a scheme
funded entirely through an excise tax on vaccines.[
Footnote 22] Through that program,
Congress relieved vaccine manufacturers of the burden of
compensating victims of vaccine-related injuries in the vast
majority of cases[
Footnote
23]—an extremely significant economic benefit that
“functionally creat[es] a valuable insurance policy for
vaccine-related injuries.” Reply Brief for Petitioners 10. The
structure and legislative history, moreover, point clearly to
Congress’ intention to divert would-be tort claimants into the
compensation program, rather than eliminate a longstanding category
of traditional tort claims. See 1986 Report 13 (“The Committee
anticipates that the speed of the compensation program, the low
transaction costs of the system, the no-fault nature of the
required findings, and the relative certainty and generosity of the
system’s awards will divert a significant number of potential
plaintiffs from litigation”). Indeed, although complete pre-emption
of tort claims would have eliminated the principal source of the
“unpredictability” in the vaccine market, Congress specifically
chose
not to pre-empt state tort claims categorically. See
42 U. S. C. §300aa–22(a) (providing as a “[g]eneral rule” that
“State law shall apply to a civil action brought for damages for a
vaccine-related injury or death”). That decision reflects Congress’
recognition that court actions are essential because they provide
injured persons with significant procedural tools—including, most
importantly, civil discovery—that are not available in
administrative proceedings under the compensation program. See
§§300aa–12(d)(2)(E), (d)(3). Congress thus clearly believed there
was still an important function to be played by state tort law.
Instead of eliminating design defect liability
entirely, Congress enacted numerous measures to reduce
manufacturers’ liability exposure, including a limited regulatory
compliance presumption of adequate warnings, see §300aa–22(b)(2),
elimination of claims based on failure to provide direct warnings
to patients, §300aa–22(c), a heightened standard for punitive
damages, §300aa–23(d)(2), and, of course, immunity from damages for
“unavoidable” side effects, §300aa–22(b)(1). Considered in light of
the Vaccine Act as a whole, §22(b)(1)’s exemption from liability
for unavoidably unsafe vaccines is just one part of a broader
statutory scheme that reflects Congress’ careful balance between
providing adequate compensation for vaccine-injured children and
conferring substantial benefits on vaccine manufacturers to ensure
a stable and predictable childhood vaccine supply.
The majority’s decision today disturbs that
careful balance based on a bare policy preference that it is better
“to leave complex epidemiological judgments about vaccine design to
the FDA and the National Vaccine Program rather than juries.”
Ante, at 15.[
Footnote
24] To be sure, reasonable minds can disagree about the wisdom
of having juries weigh the relative costs and benefits of a
particular vaccine design. But whatever the merits of the
majority’s policy preference, the decision to bar all design defect
claims against vaccine manufacturers is one that Congress must
make, not this Court.[
Footnote
25] By construing §22(b)(1) to pre-empt all design defect
claims against vaccine manufacturers for covered vaccines, the
majority’s decision leaves a regulatory vacuum in which no
one—neither the FDA nor any other federal agency, nor state and
federal juries—ensures that vaccine manufacturers adequately take
account of scientific and technological advancements. This concern
is especially acute with respect to vaccines that have already been
released and marketed to the public. Manufacturers, given the lack
of robust competition in the vaccine market, will often have little
or no incentive to improve the designs of vaccines that are already
generating significant profit margins. Nothing in the text,
structure, or legislative history remotely suggests that Congress
intended that result.
I respectfully dissent.
Footnote 1
W. Keeton, D. Dobbs, R. Keeton, & D.
Owen, Prosser and Keeton on Law of Torts 695 (5th ed. 1984).
Footnote 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))).
Footnote 3
This leaves the question of what precisely
§22(b)(1) means by “unavoidable” side effects, which I address in
the next section.
Footnote 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
prescription of a physician. It is also true in particular of many
new or experimental drugs as to which, because of lack of time and
opportunity for sufficient medical experience, there can be no
assurance of safety, or perhaps even of purity of ingredients, but
such experience as there is justifies the marketing and use of the
drug notwithstanding a medically recognizable risk. The seller of
such products, again with the qualification that they are properly
prepared and marketed, and proper warning is given, where the
situation calls for it, is not to be held to strict liability for
unfortunate consequences attending their use, merely because he has
undertaken to supply the public with an apparently useful and
desirable product, attended with a known but apparently reasonable
risk.” Restatement 353–354.
Footnote 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 availability … of any
alternative product that would have
as effectively
accomplished the
full intended purpose of the subject
product”), disapproved in part by
Brown v.
Superior
Ct., 44 Cal. 3d 1049, 751 P. 2d 470 (1988);
Belle
Bonfils Memorial Blood Bank v.
Hansen, 665 P. 2d
118, 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
omitted)). To be sure, a number of courts at the time of the
Vaccine Act’s enactment had interpreted comment
k to
preclude design defect claims categorically for certain kinds of
products, see
Hill v.
Searle Labs., 884
F. 2d 1064, 1068 (CA8 1989) (collecting cases), but as
indicated by the sources cited above, the courts that had construed
comment
k to apply on a case-specific basis generally
agreed on the basic elements of what constituted an “unavoidably
unsafe” product. See also n. 8,
infra. The majority’s
suggestion that “judges who must rule on motions to dismiss,
motions for summary judgment, and motions for judgment as a matter
of law” are incapable of adjudicating claims alleging “unavoidable”
side effects,
ante, at 7–8, n. 35, is thus belied by the
experience of the many courts that had adjudicated such claims for
years by the time of the Vaccine Act’s enactment.
Footnote 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 Security, see 42 U. S. C.
§301
et seq., Medicare, see §1395
et seq., and
several other of the Federal Government’s largest entitlement
programs. The singular rarity in which Congress used the term
supports the conclusion that “unavoidable” is a term of art.
Footnote 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).
Footnote 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 improper directions or inadequate warnings [they]
should pursue recompense in the compensation system, not the tort
system.” 1986 Report 26. It also finds some support in the
pre-Vaccine Act case law, which reflected considerable disagreement
in the courts over “whether comment k applies to pharmaceutical
products across the board or only on a case-by-case basis.”
Ausness, Unavoidably Unsafe Products and Strict Products Liability:
What Liability Rule Should be Applied to the Sellers of
Pharmaceutical Products? 78 Ky. L. J. 705, 708, and n. 11
(1989–1990) (collecting cases). This interpretation, however, is
undermined by the fact that Congress has never directed the Food
and Drug Administration (FDA) or any other federal agency to review
vaccines for optimal vaccine design, see
infra, at 20–22,
and n. 19, and thus it seems highly unlikely that Congress
intended to eliminate the traditional mechanism for such review
(
i.e., design defect liability), particularly given its
express retention of state tort law in the Vaccine Act, see 42 U.
S. C. §300aa–22(a). In any event, to the extent there is
ambiguity as to how precisely Congress intended the “principle in
Comment K” to apply to the covered vaccines, that ambiguity is
explicitly resolved in petitioners’ favor by the 1987 House Energy
and Commerce Committee Report, H. R. Rep. No. 100–391, pt. 1, pp.
690–691 (hereinafter 1987 Report). See
infra this page and
11–12.
Footnote 9
The Third Circuit’s opinion below expressed
uncertainty as to whether the 1987 Report was authored by the House
Budget Committee or the House Energy and Commerce Committee. See
561 F. 3d 233, 250 (2009). As petitioners explain, although
the Budget Committee compiled and issued the Report, the Energy and
Commerce Committee wrote and approved the relevant language. Title
IV of the Report, entitled “Committee on Energy and Commerce,”
comprises “two Committee Prints approved by the Committee on Energy
and Commerce for inclusion in the forthcoming reconciliation bill.”
1987 Report 377, 380.
Footnote 10
The majority suggests that the 1987
legislation creating the funding mechanism is akin to
appropriations legislation and that giving weight to the
legislative history of such legislation “would set a dangerous
precedent.”
Ante, at 18. The difference, of course, is
that appropriations legislation ordinarily funds congressional
enactments that already have operative legal effect; in contrast,
operation of the tort reforms in the 1986 Act, including §22(b)(1),
was expressly conditioned on the enactment of a separate tax to
fund the compensation program. See §323(a), 100 Stat. 3784.
Accordingly, this Court’s general reluctance to view appropriations
legislation as modifying substantive legislation, see,
e.g.,
TVA v.
Hill,
437 U. S. 153, 190
(1978), has no bearing here.
Footnote 11
See 1987 Report 700 (describing the
administration’s alternative proposal).
Footnote 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 particular, manufacturers
should not face liability under a ‘design defect’ theory in cases
where plaintiffs challenge the decisions of public health
authorities and federal regulators that the licensed vaccines are
the best available way to protect children from deadly diseases”
(statement of Robert B. Johnson, President, Lederle Laboratories
Division, American Cyanamid Co.)).
Footnote 13
See American Academy of Pediatrics, Questions
and Answers about Vaccine Ingredients (Oct. 2008),
http://www.aap.org/immunization/
families/faq/Vaccineingredients.pdf (all Internet materials as
visited Feb. 18, 2011, and available in Clerk of Court’s case
file).
Footnote 14
In this manner, the “even though” clause
functions in a “concessive subordinat[ing]” fashion,
ante,
at 11, in accord with normal grammatical usage. According to the
majority, however, the “even though” clause “clarifies the word
that precedes it” by “delineat[ing]” the conditions that make a
side effect “unavoidable” under the statute.
Ante, at 7.
The majority’s interpretation hardly treats the clause as
“concessive,” and indeed strains the meaning of “even though.” In
the majority’s view, proper manufacturing and labeling are the sole
prerequisites that render a vaccine’s side effects unavoidable.
Thus, an injurious side effect is unavoidable
because the
vaccine was properly prepared and labeled, not “even though” it
was. The two conjunctions are not equivalent: The sentence “I am
happy
even though it is raining” can hardly be read to
mean that “I am happy
because it is raining.” In any
event, the more fundamental point is that petitioners’
interpretation actually gives meaning to the words “even though,”
whereas the majority concedes that its interpretation effectively
reads those words entirely out of the statute. See
supra
this page.
Footnote 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 Congress.”
Altria Group, Inc. v.
Good, 555 U. S. ___, ___ (2008) (slip op., at 5) (internal
quotation marks and alteration omitted). Given the long history of
state regulation of vaccines, see Brief for Petitioners 3–6, the
presumption provides an additional reason not to read §22(b)(1) as
pre-empting all design defect claims, especially given Congress’
inclusion of 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)).
Footnote 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 recognized in other
jurisdictions that had expressly adopted comment
k.
Footnote 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
negligence”);
Toner, 112 Idaho, at 340, 732 P. 2d, at
309–310 (“The authorities universally agree that where a product is
deemed unavoidably unsafe, the plaintiff is deprived of the
advantage of a strict liability cause of action, but may proceed
under a negligence cause of action”).
Footnote 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”).
Footnote 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
vaccine designs only if and when manufacturers come forward with a
proposal”);
Jones v.
Lederle Labs., 695
F. Supp. 700, 711 (EDNY 1988) (“[T]he agency takes the drugs
and manufacturers as it finds them. While its goal is to oversee
inoculation with the best possible vaccine, it is limited to
reviewing only those drugs submitted by various manufacturers,
regardless of their flaws”). Although the FDA has authority under
existing regulations to revoke a manufacturer’s biologics licenses,
that authority can be exercised only where (as relevant here)
“[t]he licensed product is not safe and effective for all of its
intended uses.” 21 CFR §601.5(b)(1)(vi) (2010); see §600.3(p)
(defining “safety” as “relative freedom from harmful effect to
persons affected, directly or indirectly, by a product when
prudently administered, taking into consideration the character of
the product in relation to the condition of the recipient at the
time”). The regulation does not authorize the FDA to revoke a
biologics license for a manufacturer’s failure to adopt an optimal
vaccine design in light of existing science and technology. See
Conk, Is There a Design Defect in the Restatement (Third) of Torts:
Products Liability? 109 Yale L. J. 1087, 1128–1129 (1999–2000)
(“The FDA does not claim to review products for optimal design . .
. . FDA review thus asks less of drug . . . manufacturers than the
common law of products liability asks of other kinds of
manufacturers”). At oral argument, counsel for
amicus
United States stated that the Centers for Disease Control and
Prevention (CDC) routinely performs comparative analyses of
vaccines that are already on the market. See Tr. of Oral Arg.
44–45;
id., at 52–53 (describing CDC’s comparison of Sabin
and Salk polio vaccines). Neither the United States nor any of the
parties, however, has represented that CDC examines whether a safer
alternative vaccine
could have been designed given
practical and scientific limits, the central inquiry in a state
tort law action for design defect. CDC does not issue biologics
licenses, moreover, and thus has no authority to require a
manufacturer to adopt a different vaccine design.
Footnote 20
Indeed, we observed in
Levine that
the FDA is perpetually understaffed and underfunded, see 555 U. S.,
at ___, n. 11 (slip op., at 22, n. 11), and the agency
has been criticized in the past for its slow response in failing to
withdraw or warn about potentially dangerous products, see,
e.g., L. Leveton, H. Sox, & M. Soto, Institute of
Medicine, HIV and the Blood Supply: An Analysis of Crisis
Decisionmaking (1995) (criticizing FDA response to transmission of
AIDS through blood supply). These practical shortcomings reinforce
the conclusion that “state law offers an additional, and important,
layer of consumer protection that complements FDA regulation.”
Levine, 555 U. S., at ___ (slip op., at 23).
Footnote 21
The majority mischaracterizes my position as
expressing a general “skeptic[ism] of preemption unless the
congressional substitute operate[s] like the tort system.”
Ante, at 16. Congress could, of course, adopt a regulatory
regime that operates differently from state tort systems, and such
a difference is not necessarily a reason to question Congress’
pre-emptive intent. In the specific context of the Vaccine Act,
however, the relevant point is that this Court should not lightly
assume 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.
Footnote 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/
vaccines/programs/vfc/cdc-vac-price-list.htm. Accordingly, the only
way the vaccine manufacturers can be said to actually “fund” the
compensation program is if the cost of the excise tax has an impact
on the number of vaccines sold by the vaccine manufacturer. The
majority points to no evidence that the excise tax—which ordinarily
amounts to 75 cents per dose, 26 U. S. C. §4131(b)—has any
impact whatsoever on the demand for vaccines.
Footnote 23
See Brief for United States as
Amicus
Curiae 28 (“Department of Justice records indicate that 99.8%
of successful Compensation Program claimants have accepted their
awards, foregoing any tort remedies against vaccine
manufacturers”); S. Plotkin, W. Orenstein, & P. Offit, Vaccines
1673 (5th ed. 2008) (noting that “[v]irtually all … petitioners,
even those who were not awarded compensation” under the
compensation program, choose to accept the program’s
determination).
Footnote 24
Justice Breyer’s separate concurrence is even
more explicitly policy driven, reflecting his own preference for
the “more expert judgment” of federal agencies over the “less
expert” judgment of juries.
Ante, at 5.
Footnote 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. According to respondent, a ruling that
§22(b)(1) does not pre-empt design defect claims could unleash a
“crushing wave” of tort litigation that would bankrupt vaccine
manufacturers and deplete vaccine supply.
Id., at 28. This
concern underlies many of the policy arguments in respondent’s
brief and appears to underlie the majority and concurring opinions
in this case. In the absence of any empirical data, however, the
prospect of an onslaught of autism-related tort litigation by
claimants denied relief by the Vaccine Court seems wholly
speculative. As an initial matter, the special masters in the
autism cases have thus far uniformly rejected the alleged causal
link between vaccines and autism. See Brief for American Academy of
Pediatrics et al. as
Amici Curiae 20–21, n. 4
(collecting cases). To be sure, those rulings do not necessarily
mean that no such causal link exists, cf. Brief for United States
as
Amicus Curiae 29 (noting that injuries have been added
to the Vaccine Injury Table for existing vaccines), or that
claimants will not ultimately be able to prove such a link in a
state tort action, particularly with the added tool of civil
discovery. But these rulings do highlight the substantial hurdles
to recovery a claimant faces. See
Schafer v.
American
Cyanamid Co., 20 F. 3d 1, 5 (CA1 1994) (“[A] petitioner
to whom the Vaccine Court gives nothing may see no point in trying
to overcome tort law’s yet more serious obstacles to recovery”).
Trial courts, moreover, have considerable experience in efficiently
handling and disposing of meritless products liability claims, and
decades of tort litigation (including for design defect) in the
prescription-drug context have not led to shortages in prescription
drugs. Despite the doomsday predictions of respondent and the
various
amici cited by the concurrence,
ante, at
6–7, the possibility of a torrent of meritless lawsuits bankrupting
manufacturers and causing vaccine shortages seems remote at best.
More fundamentally, whatever the merits of these policy arguments,
the issue in this case is what Congress has decided, and as to that
question, the text, structure, and legislative history compel the
conclusion that Congress intended to leave the courthouse doors
open for children who have suffered severe injuries from
defectively designed vaccines. The majority’s policy-driven
decision to the contrary usurps Congress’ role and deprives such
vaccine-injured children of a key remedy that Congress intended
them to have.
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