The opinion
FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
ERIN HOLMES; SHAWN HOLMES, No. 08-16557
Plaintiffs-Appellants, D.C. No.
v. 2:04-cv-00608-
MERCK & CO., INC., BES-GWF
Defendant-Appellee.
OPINION
Appeal from the United States District Court
for the District of Nevada
Brian E. Sandoval, District Judge, Presiding
Argued and Submitted December 3, 2009
Resubmitted on April 1, 2011
San Francisco, California
Filed September 25, 2012
Before: Betty B. Fletcher, Sidney R. Thomas, and
N. Randy Smith, Circuit Judges.
Opinion by Judge Thomas
11791
HOLMES v. MERCK & CO., INC. 11793
COUNSEL
Eckly M. Keach and Robert E. Murdock, Las Vegas, Nevada,
for the appellants.
11794 HOLMES v. MERCK & CO., INC.
Denice Barton, Las Vegas, Nevada, and Donald F. Zimmer,
San Francisco, California, for the appellees.
OPINION
THOMAS, Circuit Judge:
Erin and Shawn Holmes appeal the district court’s grant of
summary judgment in favor of Merck & Company in their
diversity action alleging wrongful death. They contend that
the district court erred in applying the standards of the
National Childhood Vaccine Injury Act (Vaccine Act or the
Act), 42 U.S.C. § 300aa-22, to their individual claims for
damages. We have jurisdiction pursuant to 28 U.S.C. § 1291.
We affirm.
I
When Jacob Holmes was one year old, his pediatrician
administered M-M-R II,1 a vaccine manufactured and distrib-
uted by Merck, in conformity with the recommendations set
by the Centers for Disease Control and Prevention. Within
nine days, Jacob began experiencing seizures and developed
encephalopathies. He died approximately six months later.2
Acting on behalf of their son Jacob’s estate, Erin and Shawn
Holmes petitioned for compensation from a government fund
created by the Vaccine Act. They received $250,000 through
the program.
1
M-M-R II, the Measles, Mumps, and Rubella, Virus Vaccine Live, was
approved by the Food and Drug Administration (“FDA”) in 1978 for dis-
tribution in the United States. The vaccine has led to more than a ninety-
nine percent decrease in those diseases since its introduction.
2
The parties disagree about whether the vaccine caused Jacob’s death,
but causation was not at issue in the district court’s summary judgment
ruling.
HOLMES v. MERCK & CO., INC. 11795
Subsequently, acting in their individual capacity and pursu-
ant to Nevada Revised Statute section 41.085, the Holmes ini-
tiated this wrongful death lawsuit in Clark County, Nevada.3
Their complaint set forth allegations of negligence, strict
product liability, negligent design, failure to warn, misrepre-
sentation, express warranty, implied warranty of merchanta-
bility, implied warranty of fitness for a particular purpose, and
punitive damages. Merck removed the case to the United
States District Court for the District of Nevada.
After three years of discovery, Merck filed a motion for
summary judgment, arguing, as is relevant here, that the Vac-
cine Act foreclosed Plaintiffs’ lawsuit. The district court only
partially agreed, holding that the Act limited Plaintiffs’ strict
liability and negligence claims to the extent that the claims
relied on allegations of design defect and failure to warn. But
the district court disagreed with Merck’s assertion that the
Vaccine Act limited Plaintiffs’ other state law claims. The
district court therefore granted in part and denied in part
Merck’s summary judgment motion and requested supple-
mental briefing on Plaintiffs’ claims of misrepresentation,
breach of warranty, and punitive damages. Following supple-
mental briefing on these remaining state law claims, the dis-
trict court granted Merck summary judgment. Plaintiffs then
filed a timely appeal to this court, challenging only the district
court’s application of Section 22 of the Vaccine Act to their
3
As is relevant, Nevada’s Wrongful Death Statute states:
When the death of any person, whether or not a minor, is caused
by the wrongful act or neglect of another, the heirs of the dece-
dent . . . may each maintain an action for damages against the
person who caused the death . . . . The heirs may prove their
respective damages in the action . . . and the court or jury may
award each person pecuniary damages for the person’s grief or
sorrow, loss of probable support, companionship, society, com-
fort and consortium, and damages for pain, suffering or disfigure-
ment of the decedent.
Nev. Rev. Stat. § 41.085(2)-(4).
11796 HOLMES v. MERCK & CO., INC.
design defect and failure to warn claims. After oral argument,
we deferred submission of the case to await the Supreme
Court’s decision in Bruesewitz v. Wyeth, 562 U.S. ___, 131 S.
Ct. 1068 (2011).
We review de novo a district court’s decision to grant sum-
mary judgment. See, e.g., Universal Health Servs., Inc. v.
Thompson, 363 F.3d 1013, 1019 (9th Cir. 2004). We also
review de novo a district court’s interpretation and construc-
tion of a federal statute. Lively v. Wild Oats Mkts., Inc., 456
F.3d 933, 938 (9th Cir. 2006).
II
A
The question in this appeal is whether the National Child-
hood Vaccine Injury Act preempts all or part of the Plaintiffs’
claims. The National Childhood Vaccine Injury Act is part of
the federal government’s larger program of approving, regu-
lating, and promoting vaccines. See National Childhood Vac-
cine Injury Act of 1986, Pub. L. No. 99-660, Tit. III, 100 Stat.
3743, 3756-3784 (codified as amended at 42 U.S.C. § 300aa-
1 et seq.). The Act arose out of an attempt to balance the need
for widespread childhood vaccinations with the need for “op-
timal prevention against adverse reactions to vaccines.” 42
U.S.C. § 300aa-1. Congress passed the law after hearing testi-
mony that, although vaccines inevitably harmed only a very
small number of people, litigation arising from these injuries
was threatening the stability of the nation’s vaccine program.
See H.R. Rep. No. 99-908, at 4-7 (1986), reprinted in 1986
U.S.C.C.A.N. 6344, 6345-48. In particular, injured persons
complained about the tort law system’s uncertain and inequi-
table recoveries, while vaccine manufacturers testified that the
high cost of litigation was causing insurance premiums to rise
and reducing the number of manufacturers willing to sell
childhood vaccines. See id. at 6-7; see also Bruesewitz, 131
HOLMES v. MERCK & CO., INC. 11797
S. Ct. at 1072-74 (describing impetus behind Vaccine Act’s
creation).
[1] Congress addressed these concerns by establishing a
“no fault” national vaccine injury compensation program
through which vaccine-injured persons might quickly and eas-
ily obtain damage awards from a “Vaccine Court.” See
Schafer v. Am. Cyanamid Co., 20 F.3d 1, 2 (1st Cir. 1994)
(describing compensation system and coining “Vaccine
Court” term).
Part II of the Act set forth the parameters of this compensa-
tion scheme and instituted a “Vaccine Injury Table” to cover
the vaccines and injuries, for which individuals could seek com-
pensation.4 42 U.S.C. § 300aa-14. Two provisions within Part
II—Section 11 and Section 22—are central to the issues pre-
sented in this case.
[2] First, in Section 11, Congress stipulated that any claim-
ant “qualified” to bring a claim in Vaccine Court must do so
in advance of bringing a civil suit. 42 U.S.C. § 300aa-
4
Specifically, a claimant may file a petition for compensation with a
specially constituted “Vaccine Court,” operating under the United States
Court of Federal Claims. 42 U.S.C. §§ 300aa-11, 300aa-12. In almost all
circumstances, a special master makes a decision on the claimant’s peti-
tion within 240 days. § 300aa-12(d)(3). The Court of Federal Claims then
reviews any objections to the special master’s decision and enters final
judgment within 120 days. § 300aa-12(e). This informal adjudication
relies on the Act’s “Vaccine Injury Table,” which describes the side
effects associated with each vaccine and provides a timetable as to when
those effects should manifest themselves. § 300aa-14(a); 42 C.F.R.
§ 100.3 (current Vaccine Injury Table). Unlike in tort suits, a claimant
whose injuries fall within the Table does not need to show causation or
fault; rather the claimant need only show by a preponderance of the evi-
dence that he received a listed vaccine and then suffered certain symptoms
within a defined period of time. 42 U.S.C. §§ 300aa-13, 300aa-14. Follow-
ing the adjudication, a claimant may either accept the court’s judgment
and forego a traditional tort suit for damages, or reject the judgment and
seek tort relief from the vaccine manufacturer. § 300aa-21(a).
11798 HOLMES v. MERCK & CO., INC.
11(a)(2)(A).5 The Act specifies that a qualified claimant is
“any person who has sustained a vaccine-related injury” after
“receiv[ing] a vaccine set forth in the Vaccine Injury Table.”
§ 300aa-11(b)-(c). If a person is not qualified to file a petition
for compensation under the Program, then this subsection’s
exhaustion requirement does not apply. § 300aa-11(a)(9).
[3] Finally, if the person who sustained the vaccine-related
injury is a minor, disabled or deceased, the Act permits that
person’s parent or legal representative to file for compensa-
tion on behalf of the injured person’s estate. § 300aa-
11(b)(1)(A). A parent or legal representative may not, how-
ever, file in Vaccine Court for compensation of his or her own
individual damages. See § 300aa-15(d)(2) (“Compensation
awarded under the Program may not include . . . compensa-
tion for other than the health, education, or welfare of the per-
son who suffered the vaccine-related injury with respect to
which the compensation is paid.”) (emphasis added). Thus,
although we have never had an occasion to rule on the ques-
tion, our sister courts have consistently held that Section 11’s
exhaustion requirement does not apply to a parent’s claim for
his or her individual injuries. See, e.g., Moss v. Merck & Co.,
381 F.3d 501, 505-06 (5th Cir. 2004); Schafer, 20 F.3d at 5-
7.
Section 22 of the Vaccine Act meanwhile provides vaccine
manufacturers “significant tort-liability protections,”
Bruesewitz, 131 S. Ct. at 1074, by eliminating liability for
injuries from “unavoidable side effects,” 42 U.S.C. § 300aa-
5
In relevant part, 42 U.S.C. § 300aa-11(a)(2)(A) provides:
No person may bring a civil action for damages . . . against a vac-
cine administrator or manufacturer in a State or Federal court for
damages arising from a vaccine-related injury or death associated
with the administration of a vaccine . . . and no such court may
award damages . . . for such a vaccine-related injury or death,
unless a petition has been filed, in accordance with section
300aa-16 of this title, for compensation under the Program for
such injury or death[.]
HOLMES v. MERCK & CO., INC. 11799
22(b)(1); eliminating liability for not providing direct warn-
ings to a claimant, § 300aa-22(c); and imposing a presump-
tion that a manufacturer provided proper directions and
warnings if the manufacturer complied with FDA require-
ments, § 300aa-22(b)(2).6 In this way, the Act sets up a quid
6
In relevant part, Section 22 states:
(a) General Rule
Except as provided in subsections (b), (c), and (e) of this sec-
tion State law shall apply to a civil action brought for dam-
ages for a vaccine-related injury or death.
(b) Unavoidable adverse side effects; warnings
(1) 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 pre-
pared and was accompanied by proper directions and warn-
ings.
(2) For purposes of paragraph (1), a vaccine shall be pre-
sumed to be accompanied by proper directions and warnings
if the vaccine manufacturer shows that it complied in all
material respects with all requirements under the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. § 301 et seq.] and
section 262 of this title (including regulations issued under
such provisions) applicable to the vaccine and related to
vaccine-related injury or death for which the civil action was
brought unless the plaintiff shows—
(A) that the manufacturer engaged in the conduct set forth in
subparagraph (A) or (B) of section 300aa-23(d)(2) of this
title [fraud or intentional and wrongful withholding of infor-
mation from the Secretary during any phase of a proceeding
for approval of the vaccine, after its approval, or other crimi-
nal or illegal activity relating to the safety and effectiveness
of vaccines], or
(B) by clear and convincing evidence that the manufacturer
failed to exercise due care notwithstanding its compliance
with such Act and section (and regulations issued under such
provisions).
(c) Direct warnings
11800 HOLMES v. MERCK & CO., INC.
pro quo: easier and more certain compensation in exchange
for limited remedies within the traditional tort system. See,
e.g., Bruesweitz, 131 S. Ct. at 1080 (“[T]he Act’s structural
quid pro quo leads to the same conclusion: The vaccine man-
ufacturers fund from their sales an informal, efficient com-
pensation program for vaccine injuries; in exchange they
avoid costly tort litigation and the occasional disproportionate
jury verdict.”).
Putting these two provisions together, Plaintiffs argue that,
because Section 11 of the Vaccine Act renders them ineligible
for compensation through the Vaccine Court, no other part of
the Act, and particularly not Section 22’s tort-liability limita-
tions, should apply to their claims in state court. We disagree.
The exhaustion requirement in Section 11 is only a subsection
of Congress’s larger statutory scheme to ensure that vaccine
manufacturers have an affordable and predictable way of han-
dling injured parties’ compensation claims. Though parents
are not bound by Section 11’s exhaustion requirement, they
are not free from the Act’s tort liability limitations. Regard-
less of whether a plaintiff is the vaccine-recipient or the par-
ent of one, Section 22 expressly preempts design-defect
claims seeking compensation for injury or death caused by a
vaccine’s unavoidable side effects. § 300aa-22(b). Section 22
expressly preempts tort suits based “solely” on the manufac-
turer’s failure to provide direct warnings to the injured party.
§ 300aa-22(c). In reaching these conclusions, we do not sug-
gest that the Act otherwise forecloses a parent’s state law
claims.
No vaccine manufacturer shall be liable in a civil action for
damages arising from a vaccine-related injury or death asso-
ciated with the administration of a vaccine after October 1,
1988, solely due to the manufacturer’s failure to provide
direct warnings to the injured party (or the injured party’s
legal representative) of the potential dangers resulting from
the administration of the vaccine manufactured by the manu-
facturer.
HOLMES v. MERCK & CO., INC. 11801
B
Preemption law begins with the presumption that Congress
does not “intend to displace state law.” Maryland v. Louisi-
ana, 451 U.S. 725, 746 (1981). State action may nonetheless
be “foreclosed by express language in a congressional enact-
ment, by implication from the depth and breadth of a congres-
sional scheme that occupies the legislative field, or by
implication because of a conflict with a congressional enact-
ment.” Lorillard Tobacco v. Reilly, 533 U.S. 525, 541 (2001)
(internal citations omitted). Thus, when construing an express
preemption clause, a reviewing court must necessarily begin
by examining the clause’s “plain wording,” as this “necessar-
ily contains the best evidence of Congress’ pre-emptive
intent.” Sprietsma v. Mercury Marine, 537 U.S. 51, 62-63
(2002). “We must not be guided by a single sentence or mem-
ber of a sentence, but look to the provisions of the whole law,
and to its object and policy.” Pilot Life Ins. Co. v. Dedeaux,
481 U.S. 41, 51 (1987); see also Freightliner Corp. v. Myrick,
514 U.S. 280, 288 (1995) (“The fact that an express definition
of the pre-emptive reach of a statute ‘implies’—i.e., supports
a reasonable inference—that Congress did not intend to pre-
empt other matters does not mean that the express clause
entirely forecloses any possibility of implied pre-emption.”).
[4] Congress included several clauses in Section 22 that
inform our preemption determination. First, in Section 22(a),
the Act establishes a default that traditional state tort remedies
remain except in several enumerated instances, including as
provided for in subsection (b). 42 U.S.C. § 300aa-22(a)
(“Except as provided in subsections (b), (c), and (e) of this
section State law shall apply to a civil action brought for dam-
ages for a vaccine-related injury or death.”). Subsection
(b)(1), in turn, declares that manufacturers shall not be liable
for injuries caused by “side effects that were unavoidable
even though the vaccine . . . was accompanied by proper
directions and warnings.” And subsection (b)(2) states that
proper directions and warnings will be presumed when the
11802 HOLMES v. MERCK & CO., INC.
manufacturer “complied in all material respects with all
requirements under the Federal Food, Drug, and Cosmetic Act
. . . .” To rebut this presumption, the Act requires a plaintiff
to show that the manufacturer had (1) engaged in conduct that
would subject it to punitive damages under the Vaccine Act;
or (2) failed to exercise due care. § 300aa-22(b)(2)(A)-(B).
Pursuant to subsection (c), manufacturers are generally
immunized from liability for failure to warn if they have com-
plied with regulatory requirements and have given the warn-
ing to the healthcare professional, the vaccine recipient, or the
vaccine recipient’s legal representative. § 300aa-22(c); see
also Bruesewitz, 131 S. Ct. at 1074 n.25 (“[I]mmunity does
not apply if the plaintiff establishes by clear and convincing
evidence that the manufacturer was negligent, or was guilty
of fraud, intentional and wrongful withholding of information,
or other unlawful activity.”). Finally subsection (e) prohibits
any state law that is more restrictive than the Vaccine Act. 42
U.S.C. § 300aa-22(e) (“No State may establish or enforce a
law which prohibits an individual from bringing a civil action
against a vaccine manufacturer for damages for a vaccine-
related injury or death if such civil action is not barred by this
part.”).
[5] The text of these clauses indicates that Congress
expressly intended to prohibit states from regulating large
aspects of tort suits against vaccine manufacturers. The Third
Circuit explained the potential scope of this preemption provi-
sion: although “stating that ‘no state shall pass laws with the
following exceptions’ may well be broader than a provision
stating ‘state law applies with the following exceptions’ . . . .
[,] the breadth of a provision does not alter the import of the
underlying language, and here that language conveys a clear
intent to override state law civil action claims in particular,
defined circumstances.” Bruesewitz v. Wyeth Inc., 561 F.3d
233, 243 (3d Cir. 2009), aff’d, 131 S.Ct. at 1068; see also id.
at 242-43 (comparing language in Section 22 of Vaccine Act
to analogous express preemption language in Federal Ciga-
HOLMES v. MERCK & CO., INC. 11803
rette Labeling Act and Advertising Act); see, e.g., Lorillard,
533 U.S. at 541; CSX Transp., Inc. v. Easterwood, 507 U.S.
658, 662 n.2 (1993).7
In its recent decision affirming the Third Circuit’s reason-
ing in Bruesewitz, the Supreme Court elaborated:
The “even though” clause [in Section 22(b)(1)] . . . .
delineates the preventative measures that a vaccine
manufacturer must have taken for a side-effect to be
considered “unavoidable” under the statute. Provided
that there was proper manufacture and warning, any
remaining side effects, including those resulting
from design defects, are deemed to have been
unavoidable. State-law design-defect claims are
therefore preempted.
131 S. Ct. at 1075.
In Bruesewitz, the Supreme Court also discussed the inter-
play between subsections (b)(2) and (b)(1):
The structure of the [Vaccine Act] and of vaccine
regulation in general reinforces what the text of
§ 300aa-22(b)(1) suggests. A vaccine’s license spells
out the manufacturing method that must be followed
and the directions and warnings that must accom-
pany the product. Manufacturers ordinarily must
7
Other courts have reached the similar conclusion that design defect
claims are expressly preempted by Section 22. See, e.g., Abbot v. Am.
Cyanamid Co., 844 F.2d 1108, 1117 (4th Cir. 1988) (Sections 22(b), (c),
and (e) “expressly preempt state law in several respects”); Blackmon v.
Am. Home Prods. Corp., 328 F. Supp. 2d 659, 662-66 (S.D. Tex. 2004)
(same). Courts have likewise recognized the Vaccine Act’s express limita-
tions on failure to warn claims. See, e.g., Sykes v. Glaxo-SmithKline, 484
F. Supp. 2d 289, 295 (E.D. Pa 2007) (“Vaccine Act clearly bars claims
based on a vaccine manufacturer’s failure to provide warnings to an indi-
vidual who receives its vaccine.”).
11804 HOLMES v. MERCK & CO., INC.
obtain the Food and Drug Administration’s (FDA)
approval before modifying either. Deviations from
the license thus provide objective evidence of manu-
facturing defects or inadequate warnings. Further
objective evidence comes from the FDA’s
regulations—more than 90 of them—that perva-
sively regulate the manufacturing process, down to
the requirements for plumbing and ventilation sys-
tems at each manufacturing facility. Material non-
compliance with any one of them, or with any other
FDA regulation, could cost the manufacturer its
regulatory-compliance defense.
Id. at 1078-79.
Plaintiffs argue that the express preemption discussed in
Bruesewitz does not apply to their case because Bruesewitz
involved a claim brought on behalf of an injured minor child.
In such situations, Plaintiffs do not disagree that Section 22
would expressly limit some claims for compensation. But,
where as here, a plaintiff could not have first filed in Vaccine
Court for compensation of individual injuries, Plaintiffs claim
Section 22’s tort suit limitations are inapplicable. Plaintiffs
contend this construction is supported by the fact that Con-
gress did not discuss claims by parents for individual damages
in either the Vaccine Act or the Act’s legislative history.8 See
8
To support their interpretation that Section 22 has a narrow reach,
Plaintiffs heavily rely on two cases from our Sister Circuits—Schafer v.
American Cyanamid Co. and Moss v. Merck & Co.—which both held that
Section 11’s exhaustion requirement did not apply to bar parents from fil-
ing directly in state court. See Schafer, 20 F.3d at 2 (“The question before
us in this appeal . . . is whether the Act also bars the family of . . . a person
[injured by a vaccine] from bringing a tort suit to obtain compensation for
their own, related, injuries, in particular, for loss of companionship or con-
sortium. Assuming that state law permits such suits, we find nothing in the
Act that explicitly or implicitly bars them.); Moss, 381 F.3d at 505 (“The
program delays the filing of only those tort claims for which it first pro-
vides an alternate source of compensation.”). Plaintiffs cite to numerous
HOLMES v. MERCK & CO., INC. 11805
Schafer, 20 F.3d at 6 (discussing parents’ claims in context of
legislative history).
[6] We disagree with Plaintiffs’ cramped interpretation of
the Vaccine Act. Given the structure and broad purpose of the
Act as a whole, it is most reasonable to apply Section 22 to
all design defect and failure to warn claims arising out of a
vaccine-related injury or death, not just those that could have
first been brought in the Vaccine Court.
First, Part II of the Vaccine Act, in which Sections 11 and
22 appear, is much broader than Plaintiffs would have us con-
strue it. Part II not only establishes the vaccine compensation
program and Vaccine Table, but it also outlines the duties of
the Secretary of the Department of Health along with the
responsibilities and liability of vaccine manufacturers. More-
over, Part II provides any citizen—regardless of whether that
person was directly or indirectly harmed by a vaccine-related
injury—with a cause of action “against the Secretary where
there is alleged a failure of the Secretary to perform any act
or duty under [Part II of the Act].” 42 U.S.C. § 300aa-31(a).
The structure of Section 11 further demonstrates that the
Act is meant to apply broadly. As subsection (a)(9) in Section
11 explains, Section 11 “applies only to a person who has sus-
tained a vaccine-related injury or death and who is qualified
district and state court decision for the same proposition as well. See, e.g.,
Bertrand v. Aventis Pasteur Labs., Inc., 226 F.Supp. 2d 1206, 1214 (D.
Ariz. 2002); Hobart v. Holt, 194 P.3d 820, 825 (Or. Ct. App. 2008). But
critically, none of the cases cited by Plaintiffs discuss Section 22’s tort lia-
bility limitations. Cf. Schafer, 20 F.3d at 5 ([T]he Act subsection [in Sec-
tion 11] that creates the tort action bar says that [the bar] does not apply
to this kind of lawsuit.”) (emphasis added). Framed another way, these
cases interpreted Section 11 to permit parents to file directly in state court.
The current case thus picks up where these other cases left off: it considers
the claims that may be made against a vaccine manufacturer once a parent
is actually in court.
11806 HOLMES v. MERCK & CO., INC.
to file a petition[.]” § 300aa-11(a)(9). While this provision
makes clear that the subsection’s exhaustion requirements
apply only to those who personally suffered a vaccine-related
injury or death, the provision implies that other sections
throughout the Act apply to all types of potential plaintiffs.
Section 22, by comparison, applies to any “civil action for
damages arising from a vaccine-related injury.” § 300aa-
22(b). Critically, it does not contain a limiting provision
equivalent to the one in Section 11. Thus, Congress’s inclu-
sion of the restriction in Section 11—specifically its mention
that the bar applies only to that “subsection”— coupled with
the lack of such a restriction in Section 22 strongly suggest
that Congress did not intend for us to apply the Act’s tort suit
limitations in the narrow manner urged by Plaintiffs. See Paul
Revere Ins. Group v. United States, 500 F.3d 957, 962 (9th
Cir. 2007) (“It is generally presumed that Congress acts inten-
tionally and purposely when it includes particular language in
one section of a statute but omits it in another.”) (internal quo-
tation marks and citations omitted).
Section 23, entitled “Trial,” confirms this interpretation. In
particular, the section sets forth three stages—a liability
phase, a compensatory damages phase, and a punitive dam-
ages phase—by which a civil action “not barred by section
300aa-11(a)(2) of th[e Vaccine Act] shall be tried.” § 300aa-
23. By using this language to qualify the types of cases which
may proceed to trial, Congress opted for a framework inclu-
sive of all civil actions not otherwise barred by Section 11’s
exhaustion requirement. Indeed, only applying the trifurcated
scheme to lawsuits filed by injured vaccine-recipients, and not
to their parents, creates a convoluted trial and liability sce-
nario because the child’s case would be subject to the trifurca-
tion, while the parental claim would presumably proceed in a
traditional single-phased manner. Under that scenario, the
jury would apply the Section 22(b) defenses to the child’s
claims, but would apply a different set of state legal rules to
the parental claims. This interpretation would thus require us
to assume that Congress gave greater rights to family mem-
HOLMES v. MERCK & CO., INC. 11807
bers of those injured by vaccines than it did to the injured
vaccine-recipients themselves. Given that the Act’s main pur-
pose is to maintain the nation’s vaccine supply while compen-
sating the victims of vaccine-related injuries, this assumption
makes no sense.
Moreover, if we were to conclude that the parents of those
suffering a vaccine-related injury could bring design defect
and failure to warn claims outside of Section 22’s limitations,
we would be acting contrary to the statute’s central purpose
of managing vaccine manufacturers’ liability because our
construction would do little to protect the vaccine manufactur-
ers from suit. Cf. Bruesewitz, 131 S. Ct. at 1075 (“If a manu-
facturer 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.”).
Finally, in several cases where parent-plaintiffs have filed
civil actions for injuries allegedly caused by vaccines and
have sought recovery individually and on behalf of child-
plaintiffs, courts have applied Section 22 without distinguish-
ing between the claims. Most notably, this scenario played out
in American Home Products Corp. v. Ferrari, 668 S.E.2d 236
(Ga. 2008), vacated, 131 S.Ct. 1567 (2011), remanded to 710
S.E.2d 771 (Ga. 2011).
In Ferrari, two parents, individually and on behalf of their
son, sued various vaccine manufacturers alleging that mercury
in a vaccine preservative had caused the child neurological
damage. The Ferraris’ complaint also alleged several separate
state law claims for their own loss of services and emotional
distress. In reviewing these claims, the district court held that
Section 22 preempted the alleged design defect claims,
regardless of whether the parents could have first filed their
11808 HOLMES v. MERCK & CO., INC.
suit in Vaccine Court. The Georgia appellate courts reversed.
668 S.E.2d at 237. But then United States Supreme Court
vacated the Georgia courts’ judgment, making no mention of
the difference between the claims of the parents and of the
vaccine recipient. See 131 S.Ct. at 1567. On remand, the
Georgia courts did not readily address this issue either. See
710 S.E.2d at 772. In interpreting Section 22, it is thus telling
that the Ferrari Courts treated the claims of the parents and
the claims of the vaccine recipient as equally limited. See also
Sykes, 484 F. Supp. 2d at 299-301 (Section 22 barred recov-
ery for alleged design defect and failure to warn in action
filed by parents “individually and as parents of Wesley
Sykes”); Militrano v. Lederle Labs., 810 N.Y.S.2d 506, 506
(N.Y. App. Div. 2006) (Section 22 barred recovery for “the
plaintiffs” design defect and failure to warn claims based on
immunizations administered to one “infant plaintiff”); Wright
v. Aventis Pasteur, Inc., 14 A.3d 850, 852 (Pa. Super. Ct. Jan.
11, 2011) (pursuant to Section 22, no recovery for allegedly
defective design or warnings in products liability action filed
by plaintiffs “Jacqueline and Howard Wright in their own
right, and as parents and natural guardians of Jared Wright, a
minor child”), vacated, 33 A.3d 1262 (Pa. 2011); Blackmon,
328 F. Supp. 2d at 662-66.
[7] We recognize that a parent’s loss of a child is an injury
distinct from the harm the child himself suffered. But despite
Plaintiffs’ protests to the contrary, applying Section 22 to
their claims does not leave them without a remedy for their
injuries. Plaintiffs alleged eight claims plus a claim for puni-
tive damages in their state wrongful death action. Application
of Section 22 affects only two of these claims—the strict
products liability and negligence claims to the extent that they
were based upon allegations of design defect and failure to
warn. Therefore six of Plaintiffs’ claims remain unaffected by
the Act and each of these provide a possible remedy to the
injuries that they suffered as a result of Jacob’s illness and
death. Accordingly, our conclusion is in keeping with the
strong presumption that Congress does not, “without com-
HOLMES v. MERCK & CO., INC. 11809
ment, remove all means of judicial recourse for those injured
by illegal conduct.” Silkwood v. Kerr-McGee Corp., 464 U.S.
238, 251 (1984); Cf. Shafer, 20 F.3d at 6.
C
[8] Having concluded that Section 22 generally applies to
limit tort liability in a parent’s claim for individual injuries,
we must determine the extent to which it alters Plaintiffs’ law-
suit here. Said another way, we now consider if Plaintiffs’ suit
is a “civil action for damages arising from a vaccine-related
injury or death associated with the administration of a vac-
cine,” and thus limited by the Act. 42 U.S.C. § 300aa-
22(b)(1). We conclude that the Plaintiffs’ suit is so limited.
First, the Act defines the term “vaccine-related injury or
death” as “an illness, injury, condition, or death associated
with one or more of the vaccines set forth in the Vaccine
Injury Table . . . .” § 300aa-33(5). Here, the complaint alleges
“physical and emotional injuries,” and that “plaintiffs were
injured in their bodies and their spirit . . . .” Furthermore,
recovery under the Nevada wrongful death statute is for an
“injury.” See Moyer v. United States, 593 F. Supp. 145, 146
(D. Nev. 1984) (“The Nevada wrongful death statute, NRS
41.085, designates the only types of injury for which pecuni-
ary damages may be recovered in a wrongful death action.”).
Second, the injuries are “associated with a vaccination.” The
complaint alleges that the family suffered injuries “as a direct
and proximate result” of Jacob’s vaccination. Finally, there is
no debate that the M-M-R II vaccine is listed in the Vaccine
Injury Table. See 42 C.F.R. § 100.3.
III
[9] For these reasons, there is no cause to disturb the dis-
trict court’s application of Section 22 to Plaintiffs’ state law
products liability claims of design defect and failure to warn.
Nor was the district court’s grant of summary judgment in
11810 HOLMES v. MERCK & CO., INC.
favor of Merck error. During the proceedings below, Merck
produced evidence that it had complied with all regulatory
requirements related to M-M-R II. But Plaintiffs failed to sub-
mit evidence sufficient to show that the vaccine had not been
properly prepared or that it had not been accompanied by
proper directions and warnings.
Plaintiffs do not challenge on appeal the district court’s res-
olution of the state law claims that the district court held were
not preempted by the National Childhood Vaccine Injury
Compensation Act.
AFFIRMED.