Neal v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 17-2020V

(to be published)

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SARAH NEAL and RICHARD C. NEAL * Special Master Corcoran

parents of deceased infant, C.N., *

*

Petitioners, * Filed: July 24, 2018

*

v. *

* Decision without Hearing;

SECRETARY OF HEALTH * Dismissal; Vaccine Act

AND HUMAN SERVICES, * Construction; 1 U.S.C. § 8

* definition of child; Claim

Respondent. * based on in utero receipt of

* vaccine.

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Phyllis Widman, Widman Law Firm LLC, Ocean City, NJ, for Petitioners.

Traci Patton, U.S. Department of Justice, Washington, D.C., for Respondent.

DECISION DISMISSING CASE1

On December 22, 2017, Sarah and Richard Neal, parents of deceased infant, C.N., filed a

petition seeking compensation under the National Vaccine Injury Compensation Program (the

“Vaccine Program”).2 In it, the Neals alleged that the TDaP vaccine Mrs. Neal received on

December 22, 2015, while C.N. was in gestation, caused him to be delivered stillborn on

December 24, 2015. Petition at 1. At the same time this matter was initiated, Mrs. Neal filed a

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This Decision will be posted on the Court of Federal Claims’s website in accordance with the E-Government Act

of 2002, 44 U.S.C. § 3501 (2012). This means the decision will be available to anyone with access to the

internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the decision’s inclusion

of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days

within which to request redaction “of any information furnished by that party: (1) that is a trade secret or

commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar

files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b).

Otherwise, the Decision in its present form will be available. Id.

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The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,

100 Stat. 3758, codified as amended, 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the

Act”]. Individual section references hereafter will be to § 300aa of the Act.

separate petition on her own behalf but based upon the same tragic factual occurrence. See Neal

v. Sec’y of Health & Human Servs., No. 17-2021, filed Dec, 22, 2017 (ECF No. 1).

Respondent interposed a motion to dismiss this case (but not the simultaneously-filed

matter) on April 6, 2018. See Motion to Dismiss (ECF No. 10) (“Mot.”). In it, he stresses the

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undisputed fact that C.N. was delivered deceased. Ex. 2 at 57. As a result, a recent amendment to

the Vaccine Act permitting claims filed on behalf of children alleging injuries sustained in utero

after a mother’s vaccination did not apply – because the Vaccine Act (through its incorporation

of a federal statutory definition of “child”) requires that an allegedly injured child be born alive

to maintain such a claim. Mot. at 2-3, citing 21st Century Cures Act, Pub. L. No. 115-255, 130

Stat. 1033, 1152 (Dec. 13, 2016) (hereinafter, the “Vaccine Act Amendment”); 1 U.S.C. § 8(a)

and (b). Accordingly (and although Mrs. Neal’s individual claim was not similarly deficient),

Petitioners had failed to state a cognizable claim on C.N.’s behalf, and this action warranted

dismissal.

Petitioners filed a brief opposing the motion to dismiss on May 24, 2018. See Petitioners’

Opposition (ECF No. 14) (“Opp.”). Their opposition includes both attacks against Respondent’s

construction of the Vaccine Act Amendment and policy arguments. Opp.at 1. With respect to the

former, Petitioners maintain that the same definition section of the U.S. Code for “child”

includes additional language suggesting that the “born alive” provision cannot be interpreted to

limit the rights of the child before birth – meaning that the alleged in utero effects of a vaccine

should be actionable regardless of whether a fetus is ever later born. Id. at 2-3, citing 1 U.S.C. §

8(c).

Next, Petitioners make a lengthy series of arguments maintaining that Respondent’s

proposed interpretation of the Vaccine Act Amendment is contrary to, or unreasonable in light

of, established law. Thus, they reference “many examples of states in the U.S. that recognized a

torts claim on behalf of an unborn child who died in utero,” citing a single case decided by

Ohio’s Supreme Court. Opp. at 5-6. They note the existence of fetal homicide laws, as well as

dictionary definitions that allow for the possibility of an “unborn” child. Id. at 7-8. And they

invoke common law principles that they argue also support the reasonableness of understanding

the extent of an unborn child’s rights. Id. at 8-9.

Finally, Petitioners propose that if in fact Respondent’s interpretation of the Vaccine Act

Amendment is accurate, then the Amendment itself constitutes a violation of the U.S.

Constitution in several ways. First, it violates the due process clause of the Fifth Amendment to

the U.S. Constitution, because the interpretation offered by Respondent would serve to “deprive”

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Indeed, Respondent’s Reply, dated June 29, 2018 (ECF No. 18), in support of the present motion to dismiss

expressly acknowledges that Mrs. Neal’s claim meets the pleading requirements of the Vaccine Act Amendment

(although he does not concede that she will ultimately succeed in proving entitlement). Reply at 4 n.5.

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C.N. of life without due process, by denying Petitioners the opportunity to obtain redress for an

in utero-suffered injury. Opp. at 9. Second, the Vaccine Act Amendment violates the equal

protection clause of the Fourteenth Amendment (as incorporated in the Fifth Amendment) by

distinguishing the rights of unborn from delivered-live children. Id. at 10-11. Third, the Vaccine

Act Amendment is overly broad in application, resulting in an unlawful denial of a right of

redress for C.N.’s injury under the First Amendment (which guarantees the right to petition the

Government). Id. at 10. And it discriminates on the basis of age. Id. at 11.4

Respondent filed a reply in support of his motion to dismiss on June 29, 2018. Reply

(ECF No. 18). He reiterates, with additional quotation of the operable language from the Vaccine

Act Amendment (as well as an administrative rulemaking process seeking input on what

vaccines should be added to the Table to effect the Amendment’s purpose) that the scope of the

additional cause of action was limited to “live-born” children. Reply at 2-3. He also maintains

that this somewhat exclusionary understanding of what a “child” is comports with the

requirement to construe narrowly the relevant language, given that a Vaccine Act claim reflects

Congress’s determination to waive sovereign immunity. Id. at 5-6. Beyond this, Respondent

questions the relevance of conflicting state or common law definitions of “child,” noting that

federal law definitions preempt application of alternative definitions from such other sources. Id.

at 4-5. Respondent otherwise rejects Petitioners’ Constitutional arguments, noting that the cause

of action created by the Vaccine Act is only subject to review under a “rational basis” standard.

Id. at 6-7 (citing Black v. Sec’y of Health & Human Servs., 93 F.3d 781, 787-88 (1996)).

ANALYSIS

Construing the terms and provisions of the Vaccine Act entails balancing broad policy

concerns against the application of long-held, oft-repeated rules for careful statutory construction

in the federal courts. On the one hand, it is surely the case that “[r]emedial legislation like the

Vaccine Act should be construed in a matter that effectuates its underlying spirit and purpose.”

Cloer v. Sec'y of Health & Human Servs., 675 F.3d 1358, 1362 (Fed. Cir. 2012), aff'd sub nom.,

Sebelius v. Cloer, 569 U.S. 369 (2013). At the same time, there is ample authority for the

proposition - especially where a claim may be brought against the United States, as here, and

thus constitutes a partial waiver of sovereign immunity - that strict construction of the Act’s

provisions is required. Hoffman v. Sec’y of Health & Human Servs., No. 90-3451V, 1995 WL

103334, at *2 (Fed. Cl. Spec. Mstr. Feb. 21, 1995) (collecting case law supporting proposition);

but see Burch v. Sec’y of Health & Human Servs., No. 99-946V, 2010 WL 1676767, at *7

(discussing above jurisprudential concepts but concluding, in light of more recent Supreme Court

case law and in connection with interpretation of the Vaccine Act, that there has occurred a

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Petitioners’ Opposition also addresses arguments raised by Respondent about the underlying merits of the claim,

irrespective of whether it fails to state a cause of action based on the amendment’s definition of “child.”Opp. at 11-

13. My decision does not turn on these matters, however (and it is likely they will be relevant to the parallel claim

brought solely by Mrs. Neal), and I therefore do not address them at this time.

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“general relaxation” in how strictly the sovereign immunity doctrine should be applied when

constructing statutes effecting waiver of it like the Vaccine Act).

The portion of the 21st Century Cures Act pertaining to the Vaccine Act and relevant to

the pending motion states as follows:

(2) PETITION CONTENT.—Section 2111 of the Public Health Service Act (42 U.S.C.

300aa–11) is amended by adding at the end the following:

<< 42 USCA § 300aa–11 >>

“(f) MATERNAL IMMUNIZATION.—

“(1) IN GENERAL.—Notwithstanding any other provision of law, for

purposes of this subtitle, both a woman who received a covered vaccine

while pregnant and any child who was in utero at the time such woman

received the vaccine shall be considered persons to whom the covered

vaccine was administered and persons who received the covered vaccine.

“(2) DEFINITION.—As used in this subsection, the term ‘child’ shall

have the meaning given that term by subsections (a) and (b) of section 8 of

title 1, United States Code, except that, for purposes of this subsection,

such section 8 shall be applied as if the term ‘include’ in subsection (a) of

such section were replaced with the term ‘mean’.”.

<< 42 USCA § 300aa–11 >>

(3) PETITIONERS.—Section 2111(b)(2) of the Public Health Service Act

(42 U.S.C. 300aa–11(b)(2)) is amended by adding “A covered vaccine

administered to a pregnant woman shall constitute more than one

administration, one to the mother and one to each child (as such term is

defined in subsection (f)(2)) who was in utero at the time such woman was

administered the vaccine.” at the end.

Vaccine Act Amendment (130 Stat. at 1152) (emphasis added). The question of whether

an infant in utero had in fact been “administered” a vaccine, for purposes of bringing a Vaccine

Act claim, had in the past limited many otherwise-meritorious claims and caused a great deal of

perplexed reasoning by special masters. See, e.g., Burch, 2010 WL 1676767, at *7-8. As the

above statutory language suggests, a goal in amending the Vaccine Act in this manner was to

codify the availability of a cause of action for receipt of a vaccine both to the expecting mother

and her infant (with, of course, the proper parties in interest acting as representative petitioners),

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even though that infant received the vaccine indirectly, from his mother and while in utero. See

Mot. at 2-3. But this language does not resolve the present question.

The other relevant statutory provision bearing on the present motion is the United States

Code’s definition of “child.” 1 U.S.C. § 8. As that provision states,

(a) In determining the meaning of any Act of Congress, or of any ruling,

regulation, or interpretation of the various administrative bureaus and agencies of

the United States, the words “person”, “human being”, “child”, and “individual”,

shall include [or “mean,” as the Vaccine Act Amendment specifies] every infant

member of the species homo sapiens who is born alive at any stage of

development.

(b) As used in this section, the term “born alive”, with respect to a member of the

species homo sapiens, means the complete expulsion or extraction from his or her

mother of that member, at any stage of development, who after such

expulsion or extraction breathes or has a beating heart, pulsation of the umbilical

cord, or definite movement of voluntary muscles, regardless of whether the

umbilical cord has been cut, and regardless of whether the expulsion or extraction

occurs as a result of natural or induced labor, cesarean section, or induced

abortion.

(c) Nothing in this section shall be construed to affirm, deny, expand, or contract

any legal status or legal right applicable to any member of the species homo

sapiens at any point prior to being “born alive” as defined in this section.

1. U.S.C.A. § 8 (2018) (emphasis added).

Here, Petitioners argue against a plain reading of the definition of the term “born alive,”

which expressly modifies what a “child” is for purposes of the Vaccine Act Amendment. There

is no dispute that C.N. was not “born alive” -- and a reasonable reading of Section 8(b) suggests

this is a precursor element of the definition of child in Section 8(a). Accordingly, because the

facts of this case do not fit the requirements of the Vaccine Act Amendment for bringing a claim

on an infant’s behalf for in utero vaccine injury, the claim cannot be maintained.

My interpretation is consistent with what other federal courts5 have determined, in

construing different federal statutes that might be read to create a cause of action to a child while

in utero. In Sheff v. United States Dep’t of Justice – Civil Div., Rad. Exp. Comp. Pgm., No. 17-

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I have not found any Federal Circuit or Court of Federal Claims decisions interpreting the relevant “born alive”

definition.

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2153, 2018 WL 2058180 (10th Cir. May 2, 2018), for example, the 10th Circuit ruled that a

particular federal statute - (the Radiation Exposure Compensation Act (“RECA”)) - intended to

create a cause of action for individuals injured as a result of nuclear testing or employment in the

uranium industry - did not apply to individuals negatively exposed in utero to radiation, since

that exposure had occurred “prior to birth.” Sheff, 2018 WL 2058180, at *2. In so holding, the

Sheff court distinguished RECA from the Vaccine Act amendment, which did create a cause of

action arising in utero. But RECA, like the present Vaccine Act Amendment, relies on the same

Section 8 definitions relevant herein – definitions that the Sheff court recognized required a live

birth for the cause of action to be viable.

Federal statutes also creating liability for in utero harm to infants similarly illustrates the

propriety of my construction of the Vaccine Act Amendment. The Unborn Victims of Violence

Act, 18 U.S.C. § 1841, not only applies to injurious acts committed against a child in utero, like

the Vaccine Act Amendment, but specifically includes its own definition of “unborn child” that

does not incorporate or refer to the “born alive” language from Section 8(b). 18 U.S.C.A. § 1841

(d) (2018) (“As used in this section, the term “unborn child” means a child in utero, and the term

“child in utero” . . . means a member of the species homo sapiens, at any stage of development,

who is carried in the womb”). The Act Amendment, by contrast, does not go that far in extending

its views about harms done to infants in utero to permit causes of action to be brought on their

behalf even if they are never “born alive.”

It is worth noting that the seeming unfairness of this construction of the Vaccine Act

Amendment should be weighed against the existence of Mrs. Neal’s parallel claim (which

Respondent has not moved to dismiss). Even if the facts of this case prevent the Neals from

asserting a claim on C.N.’s direct behalf, Mrs. Neal still has her own claim, with all attendant

damages (including pain and suffering) available for that loss. As a result, the tragedy for which

the Neals presently seek recompense under the Vaccine Act has not been rendered beyond

remedy (and thus in contravention of the remedial purposes of the Act and this particular

amendment) simply because construction of the Amendment does not permit the claim.

Petitioners’ other arguments in favor of their preferred construction of the Vaccine Act

Amendment are no more successful than the more direct challenges discussed above. First,

arguments that certain provisions of the Vaccine Act could violate the Constitution have been

raised, and disposed of, before numerous times. See, e.g., Black v. Sec’y of Health & Human

Servs., 93 F.3d 781, 787-88 (1996) (“the Vaccine Act does not implicate any fundamental right,

for a noncontractual claim to receive funds from the public treasury enjoys no constitutionally

protected status”) (citing Weinberger v. Salfi, 422 U.S. 749, 772 (1975) (internal quotations

omitted)); see also Leuz v. Sec’y of Health & Human Servs., 63 Fed. Cl. 602, 607-612 (2005)

(finding the same). At bottom, the Court of Federal Claims has repeatedly recognized that the

remedial nature of the Vaccine Act means that its provisions are only subject to review on a

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rational basis standard, and has upheld its provisions repeatedly on that basis. Black, 93 F.3d at

787.

The Court has also affirmed the special masters’s decisions that the Act’s statute of

limitations did not violate petitioner’s “due process” and “equal protection” rights. See Cloer v.

Sec’y of Health & Human Servs., 85 Fed. Cl. 141 (2008), rev’d on other grounds, 603 F.3d 1341,

aff’d en banc, 654 F.3d 1322 (Fed. Cir. 2011). A “rational basis” test applies because no

fundamental right is at stake, and the statute of limitations is rationally related to the purposes of

the Vaccine Act: (1) settling the claims quickly and easily, and (2) protecting manufacturers

from uncertain liability and thus discouraging the production of vaccines. Id. at 151-52.

Second, Petitioners’ arguments about the Vaccine Act Amendment’s definition of child

as contrary to state or common law are unpersuasive. As Respondent has observed, Congress has

the authority under the Supremacy Clause to preempt state or common law when it conflicts with

policies set forth in a federal statute. Reply at 4-5; see Milik v. Sec’y of Health & Human Servs.,

822 F.3d 1367, 1378 (Fed. Cir. 2016) (“[t]here is no doubt Congress has the authority under the

Supremacy Clause to preempt state law causes of action which conflict with the federal standards

and policies set forth in a duly authorized federal statute . . . .”). Accordingly, the availability of

relief under state law to an infant not "born alive" does not invalidate a contrary definition of the

scope of such relief under federal law. In any event, as observed above there are other federal

statutes that incorporated their own definition of “child” despite the language in 1 U.S.C. § 8.

That did not occur here, and it cannot be said to contravene the purposes of the Vaccine Act that

Congress did not so choose to do in this case.

Accordingly, and for the reasons set forth above, the present matter fails to state a proper

claim under the requirements of the Vaccine Act Amendment, and it is accordingly

DISMISSED.

IT IS SO ORDERED.

s/Brian H. Corcoran

Brian H. Corcoran

Special Master

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