Case: 23-1032 Document: 45 Page: 1 Filed: 04/15/2024
United States Court of Appeals
for the Federal Circuit
______________________
VICTORIA LEMING, KEVIN LEMING, PARENTS
AND NATURAL GUARDIANS OF A.L., A MINOR,
Petitioners-Appellants
v.
SECRETARY OF HEALTH AND HUMAN SER-
VICES,
Respondent-Appellee
______________________
2023-1032
______________________
Appeal from the United States Court of Federal Claims
in No. 1:18-vv-00232-EDK, Chief Judge Elaine Kaplan.
______________________
Decided: April 15, 2024
______________________
ROBERT JOEL KRAKOW, I, Law Office of Robert J. Kra-
kow, New York, NY, argued for petitioners-appellants.
JULIA COLLISON, Torts Branch, Civil Division, United
States Department of Justice, Washington, DC, argued for
respondent-appellee. Also represented by ALEXIS B. BAB-
COCK, BRIAN M. BOYNTON, C. SALVATORE D'ALESSIO,
HEATHER LYNN PEARLMAN.
______________________
Case: 23-1032 Document: 45 Page: 2 Filed: 04/15/2024
2 LEMING v. HHS
Before MOORE, Chief Judge, STOLL, Circuit Judge, and
BENCIVENGO, District Judge. 1
BENCIVENGO, District Judge
A.L., the daughter of Petitioners-Appellants Victoria
and Kevin Leming, experienced immune thrombocytopenic
purpura after receiving the DTaP, Hib, and MMR vaccines.
As a result of her vaccine injury, she was hospitalized for
two weeks and underwent a bone marrow aspiration and
biopsy. The Court of Federal Claims held that the Lemings
could not establish by a preponderance of the evidence that
A.L. satisfied the “surgical intervention” severity require-
ment of 42 U.S.C. § 300aa-11(c)(1)(D)(iii). Because the
court below relied upon a legally erroneous construction of
“surgical intervention,” we reverse and remand.
BACKGROUND
A
In 1986, the National Childhood Vaccine Injury Act
(the “Vaccine Act”) was enacted to provide compensation to
vaccine recipients who suffered from injury or death caused
by a vaccine. See Pub. L. No. 99-660, § 311, 100 Stat. 3743,
3755-84 (codified as amended at 42 U.S.C. §§ 300aa-1 to -
34).
The Vaccine Act initially restricted recovery to only
those recipients who:
(i) suffered the residual effects or complications of
such illness, disability, injury, or condition for more
than 1 year after the administration of the vaccine,
(ii) incurred unreimbursable expenses due in whole
or in part to such illness, disability, injury, or
1 Honorable Cathy Ann Bencivengo, District Judge,
United States District Court for the Southern District of
California, sitting by designation.
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LEMING v. HHS 3
condition in an amount greater than $1,000, or (iii)
died from the administration of the vaccine[.]
Id. § 311, 100 Stat. at 3761.
In 2000, however, this “severity requirement” was
amended by the Children’s Health Act, Pub. L. No. 106-
310, 114 Stat. 1101, to require Vaccine Act petitioners
prove that the recipient:
(i) suffered the residual effects or complications
of such illness, disability, injury, or condition
for more than 6 months after the admin-
istration of the vaccine, or (ii) died from the
administration of the vaccine, or (iii) suf-
fered such illness, disability, injury, or con-
dition from the vaccine which resulted in
inpatient hospitalization and surgical inter-
vention[.]
42 U.S.C. § 300aa-11(c)(1)(D) (emphasis added).
The burden is on a petitioner to prove that one of these re-
quirements is met by a preponderance of the evidence.
B
On September 6, 2016, Appellants’ daughter, A.L., re-
ceived the DTaP, Hib, and MMR vaccines at her fifteen-
month well-child visit. Appx3. On September 29, 2016,
A.L. was taken to the emergency room with a rash, bleed-
ing gums, and black spots on her tongue. Id. A.L. was ad-
mitted to the hospital where doctors discovered a low
platelet count and presumed A.L. was suffering from im-
mune thrombocytopenic purpura (“ITP”). 2 Appx1102. A.L.
2 ITP is defined in the Vaccine Injury Table as the
“presence of clinical manifestations, such as petechiae, sig-
nificant bruising, or spontaneous bleeding, and by a serum
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4 LEMING v. HHS
received one dose of intravenous immunoglobulin (“IVIG”)
as a treatment for the ITP. A.L. failed to respond to the
initial IVIG treatment. She was transferred to Children’s
Hospital in Omaha, where she received a second dose of
IVIG. She again showed no improvement.
After A.L. failed to respond to two doses of IVIG, the
doctors conducted a bone marrow aspiration and biopsy to
ensure that A.L. was not suffering from cancer or other
blood cell disorders. Appx3. The aspiration and biopsy
showed no evidence of cancer or blood cell disorders. Id.
The doctors then gave A.L. intravenous steroids, which im-
proved her platelet count. Id. On October 12, 2016, A.L.
was discharged from the hospital. Id.
Between October 12 and November 21, 2016, A.L. had
multiple follow-up visits with the treating hematologist,
who consistently noted improving platelet counts and less-
ening symptoms. Appx43-44.
On December 30, 2016, A.L.’s hematologist noted that
A.L. was asymptomatic and had a normal platelet count.
At this visit, it was also noted that A.L.’s ITP “had likely
resolved at this time.” Appx2209. On April 13, 2017, the
hematologist stated that A.L. was “completely free of bleed-
ing symptomology.” Appx2238. At another visit on June
29, 2017, while some bruising was reported on A.L.’s face
and ear, and her blood smear indicated evidence of “giant
platelets,” A.L. had a normal platelet count and the doctor
wrote that A.L.’s mild B cell elevation was “likely due to
the immature immune system at her age and new B cell
differentiation following the ITP episode now resolved.”
Appx2256.
platelet count less than 50,000/mm3.” 42 C.F.R.
§ 100.3(c)(7).
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LEMING v. HHS 5
C
In February 2018, Victoria Leming and Kevin Leming
(“the Lemings”) filed a petition for compensation as guard-
ians of A.L. under the Vaccine Act, alleging that the vac-
cines A.L. received at her fifteen-month well-child visit
caused A.L. to suffer from ITP, immune dysfunction, and
immune deficiency. The Secretary challenged the petition.
The first special master issued a Ruling on the Facts, find-
ing that the Lemings did not establish by a preponderance
of the evidence that A.L. suffered the residual effects of the
vaccine injury for more than six months. However, the spe-
cial master found that the Lemings did establish that A.L.
underwent an inpatient hospitalization and surgical inter-
vention to meet the Vaccine Act’s severity requirement.
On review, the Court of Federal Claims found that the
special master’s decision on “surgical intervention” was
contrary to law. See Leming v. Sec’y of Health & Hum.
Servs., 154 Fed. Cl. 325, 334 (2021). The court below found
that dictionary definitions and the legislative history of §
300aa-11(c)(1)(D)(iii) “suggest that the intent of the ‘surgi-
cal intervention’ language was to cover surgical procedures
that are performed to directly treat or alter the course of a
vaccine-related injury, as opposed to those whose purpose
is to determine what treatment to employ.” Id. Finding
that the bone marrow aspiration and biopsy performed on
A.L. was purely diagnostic, the court below reversed the
decision of the original special master and remanded for
further proceedings.
On remand, the case was reassigned to another special
master who requested the Lemings offer more evidence to
address the “residual effects” prong of the severity require-
ment. The Lemings provided new arguments and a sup-
plemental affidavit from Ms. Leming. The special master
found that the Lemings still could not prove that A.L. suf-
fered from the “residual effects” of the vaccine injury for
more than six months in light of this Court’s decision in
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6 LEMING v. HHS
Wright v. Secretary of Health and Human Services, 22
F.4th 999, 1001-02 (Fed. Cir. 2022), issued after the Court
of Federal Claims’ reversal of the original special master
decision on the Lemings’ petition. The Lemings filed a mo-
tion for reconsideration, which was denied. The Lemings
again appealed to the Court of Federal Claims, which af-
firmed the decision of the second special master on residual
effects.
The Lemings timely appeal both the Court of Federal
Claims’ decision on “surgical intervention,” Leming, 154
Fed. Cl. at 325, and the second special master’s finding on
“residual effects.” We have jurisdiction pursuant to 42
U.S.C. § 300aa-12(f).
DISCUSSION
The statutory construction of “surgical intervention” in
§ 300aa-11(c)(1)(D) is a question of law, subject to de novo
review. See Wright, 22 F.4th at 1004.
A
We are first tasked with defining “surgical interven-
tion” as the phrase is used in the Vaccine Act. 42 U.S.C. §
300aa-11(c)(1)(D)(iii). As explained below, we hold the
term “surgical intervention,” read with the entirety of 42
U.S.C. § 300aa-11(c)(1)(D)(iii), requires a surgical act or
measure, either diagnostic or therapeutic, taken to prevent
harm to a patient or to improve the health of a patient.
Statutory construction “begins with the language of the
statute.” Hughes Aircraft Co. v. Jacobson, 525 U.S. 432,
438 (1999) (internal citations and quotations omitted). We
consider not just a “single sentence or word of the statute,
but rather the ‘provisions of the whole law,’ its object, and
its policy.” Wright, 22 F.4th at 1004 (quoting Dole v. United
Steelworkers of Am., 494 U.S. 26, 35 (1990)). If the statute
provides a clear answer, the inquiry ends there. Hughes
Aircraft Co., 525 U.S. at 438. “Beyond the statute’s text,
[the traditional tools of statutory construction] include the
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LEMING v. HHS 7
statute’s structure, canons of statutory construction, and
legislative history.” Timex V.I., Inc. v. United States, 157
F.3d 879, 882 (Fed. Cir. 1998).
Starting with the phrase “surgical intervention,” like
the Court of Federal Claims, we recognize that the Vaccine
Act does not define this phrase. As such, it is helpful to
look at the phrase’s “ordinary meaning . . . at the time Con-
gress enacted the statute.” Wisconsin Cent. Ltd. v. United
States, 585 U.S. 274, 277 (2018) (quoting Perrin v. United
States, 444 U.S. 37, 42 (1979)). Because neither we nor the
parties were able to find a definition of the phrase “surgical
intervention,” we look to the definitions of its individual
components, “surgery” and “intervention,” for guidance.
In 2000, one medical definition of “surgery” was “the
branch of medicine that treats diseases, injuries, and de-
formities by manual and operative methods.” Dorland’s Il-
lustrated Medical Dictionary at 1736-37 (29th ed. 2000).
This definition does not limit “surgery” to the purpose of
the procedure, e.g., whether it is primarily therapeutic ver-
sus diagnostic. The same dictionary defines “intervention”
as: “1. the act or fact of interfering so as to modify. 2. spe-
cifically, any measure whose purpose is to improve health
or to alter the course of a disease.” Id. at 911. Relying on
these Dorland’s dictionary definitions taken together, we
understand “surgical intervention” to require an act or
measure taken to prevent harming of a patient or to im-
prove the health of a patient, and is of the surgical variety,
for either diagnostic or therapeutic purposes.
It is also helpful to look to neighboring terms and
phrases. See United States v. Williams, 553 U.S. 285, 294
(2008) (“[A] word is given more precise content by the
neighboring words with which it is associated.”). Here,
“surgical intervention” exists in the larger phrase “inpa-
tient hospitalization and surgical intervention.” 42 U.S.C.
§ 300aa-11(c)(1)(D)(iii). “Inpatient hospitalization” works
together with “surgical intervention” to provide a
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8 LEMING v. HHS
benchmark for the class of petitioners that Congress in-
tended to meet the severity requirement of the Vaccine
Act—that is, those individuals who “suffered such illness,
disability, or condition from the vaccine,” that are severe
enough to result in “inpatient hospitalization and surgical
intervention.” Id. By requiring “inpatient hospitalization”
in addition to surgical intervention, Congress limited the
type of injury required to qualify for relief. Notably, Con-
gress did not limit the type of injury required for relief by
limiting the purpose of the surgical intervention received.
Marx v. Gen. Revenue Corp., 568 U.S. 371, 381 (2013) (the
courts should resort to the canon of expressio unius, the in-
clusion of a term means exclusion of the other, when the
context indicates that congress indeed considered “the un-
named possibility and meant to say no to it.”).
The legislative history accords with our understanding
of the term “surgical intervention.” Although the legisla-
tive record leading to the 2000 Amendment of the severity
requirement is sparse, the Amendment’s sponsors referred
to the need to expand compensation for those who suffered
from intussusception, a negative effect of the rotavirus vac-
cine that required surgery to remedy but did not typically
produce residual effects lasting longer than six months.
The 2000 Amendment’s language is not limited to cases of
intussusception, or any other specific vaccine-related in-
jury. One of the cosponsors, in supporting the 2000
Amendment, stated “[t]he modified program makes com-
pensation available if the injury requires a hospital stay or
surgery.” 146 Cong. Rec. H8206 (daily ed. Sep. 27, 2000)
(statement of Rep. Gilman).
Additionally, the original language proposed in 1999
included “(iii) suffered such illness, disability, injury or
condition from which resulted in inpatient hospitalization
and surgical intervention to correct such illness, disability,
injury or condition.” 145 Cong. Rec. S15213 (daily ed. Nov.
19, 1999) (emphasis added). The language in italics was
omitted from the final version of the Amendment. This
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LEMING v. HHS 9
limited legislative history leads us to believe that Congress
intended for the “surgical intervention” language to expand
access to recovery for those injured by the vaccines, not
limit it.
B
Here, the court below distinguished between surgical
procedures that are diagnostic and surgical procedures
that are required to treat the vaccine injury, holding that
purely diagnostic procedures do not qualify as “surgical in-
terventions” under the Vaccine Act. See Leming, 154 Fed.
Cl. at 333. We find no support for this distinction between
diagnostic and therapeutic surgical procedures in the Vac-
cine Act.
The 2000 Amendment requires only that the petition-
ers establish the vaccine recipient “suffered such illness,
disability, injury, or condition from the vaccine which re-
sulted in inpatient hospitalization and surgical interven-
tion.” 42 U.S.C. § 300aa-11(c)(1)(D)(iii). In light of the
conjunctive quality of the clause “inpatient hospitalization
and surgical intervention,” we hold that any surgical pro-
cedure—i.e., a surgical act or measure for diagnostic or
therapeutic purposes taken to prevent harm of a patient or
to improve the health of a patient—required to be con-
ducted as a result of the vaccine injury qualifies, so long as
the vaccine recipient is also hospitalized as an inpatient.
Further, the hospitalization and the surgery must both be
causally related to the recipient’s negative reaction to the
vaccine.
Here, under the proper interpretation of “surgical in-
tervention,” there is no dispute that the bone marrow aspi-
ration and biopsy performed on A.L. was a surgical
intervention. It was a surgical act taken to improve the
health of and prevent harm to A.L. The record demon-
strates that A.L. was hospitalized for two weeks as a result
of her negative reaction to the vaccine, and also had to un-
dergo a bone marrow aspiration and biopsy because she did
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10 LEMING v. HHS
not react to the initial ITP treatment. Appx1102. These
undisputed facts on their face satisfy 42 U.S.C. § 300aa-
11(c)(1)(D)(iii).
CONCLUSION
Accordingly, we reverse the Court of Federal Claims’
determination that A.L. does not satisfy 42 U.S.C. § 300aa-
11(c)(1)(D)(iii) and remand for further proceedings con-
sistent with this opinion. 3
REVERSED AND REMANDED
COSTS
Costs awarded to petitioners.
3 In finding that the Lemings have satisfied the se-
verity requirement via the “surgical intervention” lan-
guage, we find it unnecessary to address the “residual
effects” argument.