Laura Kalajdzic, Bojan Kalajdzic, on Behalf of A.k., Aminor Child v. Secretary of Health and Human Services

N OTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
LAURA KALAJDZIC, BOJAN KALAJDZIC, ON
BEHALF OF A.K., A MINOR CHILD,
Petitioners-Appellants
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee
______________________
2023-1321
______________________
Appeal from the United States Court of Federal Claims
in No. 1:17-vv-00792-CNL, Judge Carolyn N. Lerner.
______________________
Decided: June 20, 2024
______________________
AMBER WILSON, Wilson Science Law, Washington, DC,
argued for petitioners-appellants.
ALEC SAXE, Torts Branch, Civil Division, United States
Department of Justice, Washington, DC, argued for re-
spondent-appellee. Also represented by BRIAN M.
BOYNTON, C. SALVATORE D’ALESSIO, T RACI P ATTON,
HEATHER L YNN P EARLMAN.
______________________
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KALAJDZIC v. HHS 2
Before CHEN, HUGHES , and STARK, Circuit Judges.
CHEN, Circuit Judge.
A.K.’s parents, Laura and Bojan Kalajdzic (collectively,
the Kalajdzics), appeal a decision of the United States
Court of Federal Claims under the National Childhood
Vaccine Injury Act of 1986 (Vaccine Act), affirming a deci-
sion of Chief Special Master Brian H. Corcoran. The Chief
Special Master denied compensation for narcolepsy with
cataplexy allegedly caused by administration of the
FluMist vaccine. Kalajdzic ex rel. A.K. v. Sec’y of Health &
Hum. Servs., No. 17-792V, 2022 WL 2678877 (Fed. Cl. June
17, 2022) (Special Master Op.), aff’d Dkt. No. 79 (Fed. Cl.
Oct. 27, 2022).
We affirm because the Chief Special Master’s decision
applied the correct legal standard; was not arbitrary, ca-
pricious, or an abuse of discretion; and was otherwise in
accordance with the law. See 42 U.S.C. § 300aa-12(e)(2)(B).
We write for the parties and therefore omit the factual and
procedural background from this opinion.
D ISCUSSION
“In Vaccine Act cases, we review a ruling by the Court
of Federal Claims de novo, applying the same standard
that it applies in reviewing the decision of the special mas-
ter.” Moberly ex rel. Moberly v. Sec’y of Health & Hum.
Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010).
Under the Vaccine Act, a petitioner seeking compensa-
tion may prove causation in one of two ways, depending on
whether the case involves a “Table injury” or an “off-Table
injury.” Id. If the injury satisfies the criteria listed in the
Vaccine Injury Table, 42 U.S.C. § 300aa-14(a), and mani-
fested within the specified time period, then causation is
presumed. de Bazan v. Sec’y of Health & Hum. Servs., 539
F.3d 1347, 1351 (Fed. Cir. 2008); see also 42 U.S.C.
§ 300aa-11(c)(1)(C)(i). But if the injury is not listed in the
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KALAJDZIC v. HHS 3
Table or did not manifest within the specified time period,
then the petitioner must prove causation by a preponder-
ance of the evidence. de Bazan, 539 F.3d at 1351; see also
42 U.S.C. §§ 300aa-11(c)(1)(C)(ii), -13(a)(1)(A). This appeal
involves an off-Table injury.
When a petitioner claims to have suffered an off-Table
injury, we apply the test for causation articulated in Althen
v. Secretary of Health and Human Services, 418 F.3d 1274
(Fed. Cir. 2005):
[The petitioner’s] burden is to show by preponder-
ant evidence that the vaccination brought about
her injury by providing: (1) a medical theory caus-
ally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that
the vaccination was the reason for the injury; and
(3) a showing of a proximate temporal relationship
between vaccination and injury.
Id. at 1278.
A.
The Kalajdzics argue that the Chief Special Master er-
roneously applied a heightened evidentiary standard to
their burden of proof under Althen prong one by viewing
the evidence “through the lens of a laboratorian” rather
than “from the vantage point of the [Vaccine] Act’s simple
preponderance standard.” Appellants’ Br. at 58. Whether
the Chief Special Master applied the correct standard is a
legal question, which we review de novo under the “not in
accordance with law” standard. Althen, 418 F.3d at 1277–
78.
The Chief Special Master considered the evidence be-
fore him and determined that Dr. Ahmed’s causation the-
ory was “too specific to Pandemrix, and thus cannot be then
re-applied to [FluMist,] a different vaccine formulation.”
Special Master Op., 2022 WL 2678877, at *22. In the Chief
Special Master’s view, Dr. Ahmed’s theory failed to explain
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KALAJDZIC v. HHS 4
how evidence specific to Pandemrix, an adjuvanted vac-
cine, could be transitively applied to FluMist, a non-adju-
vanted vaccine with lower nucleoprotein levels due to a
different manufacturing process. Id. As for the Kalajdzics’
reliance on Vaccine Adverse Event Reporting System
(VAERS) data and case reports involving adverse events
after receipt of live attenuated influenza vaccines (LAIVs)1
as evidence connecting FluMist to narcolepsy, the Chief
Special Master found that evidence “reflexive” and not es-
pecially probative. Id. at *23.
Contrary to the Kalajdzics’ contention, the Chief Spe-
cial Master did not impose a heightened standard of scien-
tific certainty when evaluating Dr. Ahmed’s theory. Before
stating his findings, he correctly set forth the law pertinent
to the inquiry before him:
Petitioners may satisfy the first Althen prong with-
out resort to medical literature, epidemiological
studies, demonstration of a specific mechanism, or
a generally accepted medical theory. Special mas-
ters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially
thorny scientific and medical questions, and thus
scientific evidence offered to establish Althen prong
one is viewed “not through the lens of the laborato-
rian, but instead from the vantage point of the Vac-
cine Act’s preponderant evidence standard.”
Accordingly, special masters must take care not to
increase the burden placed on petitioners in offer-
ing a scientific theory linking vaccine to injury.
Special Master Op., 2022 WL 2678877, at *17 (citations
omitted).
The Chief Special Master then weighed the evidence
before him and found that the Kalajdzics’ theory had “too
1 FluMist and Pandemrix are both LAIVs.
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KALAJDZIC v. HHS 5
many omissions and gaps to conclude ‘more likely than not’
that FluMist can cause narcolepsy.” Id. at *24. In doing
so, he specifically noted his “rejection of a FluMist-narco-
lepsy association” did “not reflect a mistaken substitution
of a standard of scientific certainty in place of the [Vaccine
Act]’s lower standard of preponderance.” Id. We see no
legal error in this analysis, as we have repeatedly ex-
plained that a petitioner must prove a medical theory by a
preponderance of the evidence that a vaccination can cause
a particular injury. See, e.g., Althen, 418 F.3d at 1278; de
Bazan, 539 F.3d at 1351; W.C. v. Sec’y of Health & Hum.
Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013).
Nothing in the cases the Kalajdzics cite requires other-
wise. In Andreu, although we noted at one point that the
petitioner’s expert presented a “biologically plausible the-
ory,” Althen prong one was not disputed, and we thus could
not have endorsed a lower standard of proof than the pre-
ponderance standard. See Andreu ex rel. Andreu v. Sec’y of
Health & Hum. Servs., 569 F.3d 1367, 1375 (Fed. Cir.
2009). Moreover, neither Kottenstette v. Secretary of Health
and Human Services, 861 F. App’x 433, 439–40 (Fed. Cir.
2021), nor Capizzano v. Secretary of Health and Human
Services, 440 F.3d 1317, 1324 (Fed. Cir. 2006), undercuts
the requirement that a petitioner’s medical theory must be
proven by preponderant evidence.
While the Kalajdzics acknowledged during oral argu-
ment that Althen prong one requires proof by a preponder-
ance of the evidence, Oral Arg. at 3:12–3:43, available at
https://oralarguments.cafc.uscourts.gov/de-
fault.aspx?fl=23-1321_04042024.mp3, they appear to be
arguing that the requirements of the preponderance stand-
ard are more relaxed than what the law mandates. To the
extent they argue for a less than preponderance standard,
that is plainly inconsistent with our precedent. See, e.g.,
Moberly, 592 F.3d at 1322.
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KALAJDZIC v. HHS 6
B.
The Kalajdzics next contend that the Chief Special
Master improperly found that they failed to satisfy Althen
prong one by placing undue weight on his prior decision in
D’Tiole v. Secretary of Health and Human Services, No. 15-
085V, 2016 WL 7664475 (Fed. Cl. Nov. 28, 2016). We dis-
agree.
In D’Tiole, then-Special Master Corcoran found that
the petitioner failed to establish preponderant evidence
that FluMist could cause narcolepsy under Althen prong
one. Id. at *20, *28. In rejecting the Kalajdzics’ theory, the
Chief Special Master expanded upon his analysis in D’Tiole
to address “more recent scientific or medical studies” filed
in A.K.’s case regarding “the Pandemrix-narcolepsy associ-
ation and distinguishable versions of the flu vaccine like
FluMist.” Special Master Op., 2022 WL 2678877, at *22–
23 (“Nothing published or determined since the time of my
prior decisions has been identified in this case that would
alter the analysis.”). He specifically addressed the Sar-
kanen2 meta-analysis and the IABS Report3—two reports
published after D’Tiole issued—and found “neither at all
suggest that a FluMist-narcolepsy association has become
any more likely than it was” when D’Tiole was decided. Id.
at *23.
Contrary to the Kalajdzics’ assertion, the Chief Special
Master rejected Dr. Ahmed’s expert testimony based on
case-specific reliability grounds, not based on another
2 T. Sarkanen et al., Incidence of Narcolepsy After
H1N1 Influenza and Vaccinations: Systematic Review and
Meta-Analysis, 38 Sleep Med. Revs. 177 (2018).
3 K. Edwards et al., Narcolepsy and Pandemic Influ-
enza Vaccination: What We Know and What We Need to
Know Before the Next Pandemic? A Report from the 2nd
IABS Meeting, 60 Biologicals 1 (2019).
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KALAJDZIC v. HHS 7
expert’s testimony from D’Tiole. For example, in rejecting
Dr. Ahmed’s contention that FluMist’s LAIV character
may mimic an adjuvant’s immunologic effect, the Chief
Special Master relied on the IABS Report. Id. at *23. Sim-
ilarly, the Chief Special Master relied on other evidence
filed in A.K.’s case to reject Dr. Ahmed’s other contentions.
See, e.g., id. (“[I]t is not at all clear from the studies or other
evidence filed in this case that narcolepsy is as rare an oc-
currence in children under the age of ten as Dr. Ahmed pro-
posed . . . .”).
To succeed on their claim, the Kalajdzics must satisfy
all three Althen prongs. Our decision upholding the Chief
Special Master’s decision as to prong one is thus sufficient
to affirm his decision.
CONCLUSION
We reject the Kalajdzics’ remaining challenges to the
Chief Special Master’s specific fact findings because those
findings are neither arbitrary nor capricious, and he acted
within his discretion. We have considered the Kalajdzics’
arguments and find them unpersuasive. For the reasons
set forth above, we affirm the Chief Special Master’s denial
of entitlement under the Vaccine Act.
AFFIRMED
COSTS
No costs.
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