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-

M BES-GWF ERCK & CO., INC.,

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
COUNSEL

Eckly M. Keach and Robert E. Murdock, Las Vegas, Nevada,

for the appellants.

HOLMES v. MERCK & CO., INC. 11793
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 distributed 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. 

1M-M-R II, the Measles, Mumps, and Rubella, Virus Vaccine Live, was

approved by the Food and Drug Administration (“FDA”) in 1978 for distribution in the United States. The vaccine has led to more than a ninetynine percent decrease in those diseases since its introduction. 

2The parties disagree about whether the vaccine caused Jacob’s death,

but causation was not at issue in the district court’s summary judgment

ruling. 

11794 HOLMES v. MERCK & CO., INC.
Subsequently, acting in their individual capacity and pursuant to Nevada Revised Statute section 41.085, the Holmes initiated this wrongful death lawsuit in Clark County, Nevada.3

Their complaint set forth allegations of negligence, strict

product liability, negligent design, failure to warn, misrepresentation, express warranty, implied warranty of merchantability, 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 Vaccine 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 supplemental briefing on Plaintiffs’ claims of misrepresentation,

breach of warranty, and punitive damages. Following supplemental briefing on these remaining state law claims, the district 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

3As 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 decedent . . . 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, comfort and consortium, and damages for pain, suffering or disfigurement of the decedent. 

Nev. Rev. Stat. § 41.085(2)-(4). 

HOLMES v. MERCK & CO., INC. 11795
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 summary 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 construction 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 Childhood 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, regulating, and promoting vaccines. See National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, Tit. III, 100 Stat.

3743, 3756-3784 (codified as amended at 42 U.S.C. § 300aa1 et seq.). The Act arose out of an attempt to balance the need

for widespread childhood vaccinations with the need for “optimal prevention against adverse reactions to vaccines.” 42

U.S.C. § 300aa-1. Congress passed the law after hearing testimony 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 inequitable 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

11796 HOLMES v. MERCK & CO., INC.
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 easily 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 compensation scheme and instituted a “Vaccine Injury Table” to cover

the vaccines and injuries, for which individuals could seek compensation.4

 42 U.S.C. § 300aa-14. Two provisions within Part

II—Section 11 and Section 22—are central to the issues presented in this case. 

[2] First, in Section 11, Congress stipulated that any claimant “qualified” to bring a claim in Vaccine Court must do so

in advance of bringing a civil suit. 42 U.S.C. § 300aa4Specifically, 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 petition 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 evidence 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. Following 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). 

HOLMES v. MERCK & CO., INC. 11797
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 compensation on behalf of the injured person’s estate. § 300aa11(b)(1)(A). A parent or legal representative may not, however, 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 . . . compensation for other than the health, education, or welfare of the person 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 question, 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. § 300aa5

In relevant part, 42 U.S.C. § 300aa-11(a)(2)(A) provides: 

No person may bring a civil action for damages . . . against a vaccine 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[.] 

11798 HOLMES v. MERCK & CO., INC.
22(b)(1); eliminating liability for not providing direct warnings to a claimant, § 300aa-22(c); and imposing a presumption that a manufacturer provided proper directions and

warnings if the manufacturer complied with FDA requirements, § 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 section State law shall apply to a civil action brought for damages 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 prepared and was accompanied by proper directions and warnings. 

(2) For purposes of paragraph (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 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 information from the Secretary during any phase of a proceeding

for approval of the vaccine, after its approval, or other criminal 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 

HOLMES v. MERCK & CO., INC. 11799
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 manufacturers fund from their sales an informal, efficient compensation 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 limitations, 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 handling 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. Regardless of whether a plaintiff is the vaccine-recipient or the parent 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 manufacturer’s failure to provide direct warnings to the injured party.

§ 300aa-22(c). In reaching these conclusions, we do not suggest 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 associated 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 manufacturer. 

11800 HOLMES v. MERCK & CO., INC.
B

Preemption law begins with the presumption that Congress

does not “intend to displace state law.” Maryland v. Louisiana, 451 U.S. 725, 746 (1981). State action may nonetheless

be “foreclosed by express language in a congressional enactment, by implication from the depth and breadth of a congressional scheme that occupies the legislative field, or by

implication because of a conflict with a congressional enactment.” 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 “necessarily 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 member 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 preempt 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 damages 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

HOLMES v. MERCK & CO., INC. 11801
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 complied with regulatory requirements and have given the warning 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 vaccinerelated 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 provision: 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 Ciga11802 HOLMES v. MERCK & CO., INC.
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 reasoning 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 interplay 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 accompany the product. Manufacturers ordinarily must

7Other 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 limitations 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 individual who receives its vaccine.”).

HOLMES v. MERCK & CO., INC. 11803
obtain the Food and Drug Administration’s (FDA)

approval before modifying either. Deviations from

the license thus provide objective evidence of manufacturing defects or inadequate warnings. Further

objective evidence comes from the FDA’s

regulations—more than 90 of them—that pervasively regulate the manufacturing process, down to

the requirements for plumbing and ventilation systems at each manufacturing facility. Material noncompliance 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 Congress did not discuss claims by parents for individual damages

in either the Vaccine Act or the Act’s legislative history.8See

8To 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 filing 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 consortium. 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 provides an alternate source of compensation.”). Plaintiffs cite to numerous

11804 HOLMES v. MERCK & CO., INC.
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 construe 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. Moreover, 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 sustained 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 liability limitations. Cf. Schafer, 20 F.3d at 5 ([T]he Act subsection [in Section 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. 

HOLMES v. MERCK & CO., INC. 11805
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.” § 300aa22(b). Critically, it does not contain a limiting provision

equivalent to the one in Section 11. Thus, Congress’s inclusion 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 intentionally and purposely when it includes particular language in

one section of a statute but omits it in another.”) (internal quotation 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 damages phase—by which a civil action “not barred by section

300aa-11(a)(2) of th[e Vaccine Act] shall be tried.” § 300aa23. By using this language to qualify the types of cases which

may proceed to trial, Congress opted for a framework inclusive 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 scenario because the child’s case would be subject to the trifurcation, 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 mem11806 HOLMES v. MERCK & CO., INC.
bers of those injured by vaccines than it did to the injured

vaccine-recipients themselves. Given that the Act’s main purpose is to maintain the nation’s vaccine supply while compensating 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 manufacturers from suit. Cf. Bruesewitz, 131 S. Ct. at 1075 (“If a manufacturer could be held liable for failure to use a different

design, the word ‘unavoidable’ would do no work. A side

effect of a vaccine could always have been avoidable by use

of a differently designed vaccine not containing the harmful

element. The language of the provision thus suggests that the

design of the vaccine is a given, not subject to question in the

tort action.”). 

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 childplaintiffs, courts have applied Section 22 without distinguishing 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

HOLMES v. MERCK & CO., INC. 11807
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 recovery 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 punitive 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 com11808 HOLMES v. MERCK & CO., INC.
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’ lawsuit 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 vaccine,” and thus limited by the Act. 42 U.S.C. § 300aa22(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 pecuniary 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 district 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

HOLMES v. MERCK & CO., INC. 11809
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 submit 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 resolution of the state law claims that the district court held were

not preempted by the National Childhood Vaccine Injury

Compensation Act.

AFFIRMED.

11810 HOLMES v. MERCK & CO., INC.