Ronald E. White v. Secretary of Health and Human Services

United States Court of Appeals
for the Federal Circuit
______________________
RONALD E. WHITE,
Petitioner-Appellant
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee
______________________
2024-1372
______________________
Appeal from the United States Court of Federal Claims
in No. 1:20-vv-01319-TMD, Judge Thompson M. Dietz.
______________________
OPINION ISSUED: August 27, 2025
OPINION MODIFIED: December 22, 2025*
______________________
LISA A. ROQUEMORE, Law Offices of Lisa A. Roquemore,
Rancho Santa Margarita, CA, argued for petitioner-appel-
lant.
ALEC SAXE, Torts Branch, Civil Division, United States
Department of Justice, Washington, DC, argued for re-
spondent-appellee. Also represented by C. SALVATORE
* This opinion has been modified and reissued fol-
lowing a petition for rehearing filed by the appellant.
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WHITE v. HHS 2
D'ALESSIO, VORIS EDWARD JOHNSON, JR., HEATHER LYNN
PEARLMAN, YAAKOV ROTH, DARRYL R. WISHARD.
______________________
Before LOURIE, REYNA, and STARK, Circuit Judges.
LOURIE, Circuit Judge.
Ronald E. White appeals from a decision of the United
States Court of Federal Claims (“the Claims Court”) sus-
taining a special master’s denial of his claim for compensa-
tion under the National Childhood Vaccine Injury Act of
1986, 42 U.S.C. §§ 300aa-1 et seq. (“the Vaccine Act”).
White v. Sec’y of Health & Hum. Servs., 168 Fed. Cl. 660
(2023) (“Claims Court Decision”); White v. Sec’y of Health
& Hum. Servs., No. 20-1319V, 2023 WL 4204568 (Fed. Cl.
June 2, 2023) (“Special Master Decision”). We affirm.
BACKGROUND
White received a flu vaccine on November 1, 2017. Spe-
cial Master Decision, at *1. Over a month later, on Decem-
ber 5, 2017, he went to a clinic with a two-day history of
dry cough, nasal congestion, runny nose, fatigue, and a fe-
ver. Id. While there, a “nurse practitioner diagnosed him
with a viral infection.” Id. Five days later, on December
10, 2017, White went to the emergency department com-
plaining of sudden generalized weakness that began ear-
lier that day and ongoing upper respiratory symptoms that
he reported had lasted ten days without improvement. Id.
at *2. The attending physician suspected his generalized
weakness was a symptom of Guillain-Barré Syndrome
(“GBS”)—a neurologic condition in which the body’s im-
mune system mistakenly attacks the peripheral nerves—
while continuing to note that White was also likely still ex-
periencing a viral illness. Id.
That same day, White’s healthcare providers trans-
ferred him to a different medical center and placed him in
an intensive care unit (“ICU”) for “close monitoring of his
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WHITE v. HHS 3
respiratory status.” Id. While there, White’s providers
continued to suspect that he had GBS “given his clinical
presentation.” Id. And throughout his hospitalization
“many of his treating physicians opined or speculated that
his neurologic, GBS-like symptoms were associated with
his preceding/ongoing respiratory infection.” Id.; see id. at
*8 (“[A]t least 14 treaters associated [White’s] upper res-
piratory infection with the development of his GBS.”).
Meanwhile, none of his providers “at this time proposed his
more recent symptoms had anything to do with the flu vac-
cine he had received almost six weeks before.” Id. at *2.
Four days later, “on December 14, 2017, a sputum sam-
ple from [White’s] lungs was taken and the culture of it re-
vealed an H. influenzae infection,” i.e., a bacterial infection.
Id. at *3 (footnote omitted). Consistent with that test re-
sult, chest X-rays also showed worsening conditions in both
lungs. Id. About a week later, on December 20, 2017,
White’s doctors transferred him from the ICU to another
unit to conduct further testing to rule out GBS mimics. Id.
White’s providers “continued to repeat the hospital sum-
mary that [he] likely had experienced H. influenza[e] pneu-
monia” and upon discharge he was diagnosed with “GBS
and H. influenzae pneumonia.” Id.
On October 5, 2020, White sought compensation under
the Vaccine Act by filing a petition at the Claims Court,
which assigned his case to a special master. Id. at *1.
White alleged that his GBS-related injury was caused by
the flu vaccine that he received on November 1, 2017. Id.
The special master determined that although White had
established a prima facie case that the flu vaccine caused
his alleged injury, id. at *15, he could not prevail because
the government adequately showed that his unrelated
H. influenzae infection was the “sole substantial factor”
causing his GBS, see id. at *17–19. In so finding, the spe-
cial master also explicitly eliminated the vaccine as a
causal factor. See, e.g., id. at *18 n.16.
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WHITE v. HHS 4
White sought review of the special master’s decision in
the Claims Court. See Claims Court Decision, 168 Fed. Cl.
at 664. He argued there that the special master “erred by
making arbitrary and capricious findings of fact and by
failing to apply the correct burden of proof to the govern-
ment.” Id. The Claims Court rejected his arguments and
sustained the special master’s decision denying White en-
titlement to compensation under the Vaccine Act. Id.
White timely appealed, and we have jurisdiction under
28 U.S.C. § 1295(a)(3) and 42 U.S.C. § 300aa-12(f).
DISCUSSION
White argues that there were at least two errors in the
special master’s decision denying his petition for compen-
sation. First, White argues that the special master’s deci-
sion was not in accordance with the law because it failed to
apply the appropriate legal standard. See Appellant
Br. 19–23, 40–54. Specifically, he argues that the special
master did not hold the government to its burden of prov-
ing that a factor unrelated to the vaccine was the sole sub-
stantial cause of his GBS-related injury. Id. If the special
master had applied the correct legal standard, White con-
tends, then the special master would have found that the
evidence stands in “equipoise,” and that White is thus nec-
essarily entitled to compensation. See id. at 37–40. Sec-
ond, White argues that the special master’s findings under
the first and third prongs of the Althen test were arbitrary
and capricious.1 See id. at 24–37; Althen v. Sec’y of Health
1 White also argues that the special master’s finding
under Althen prong two was flawed, but only to the extent
that we agree with his arguments on Althen prongs one and
three. See Appellant Br. 37. Because we affirm the special
master’s findings under Althen prongs one and three, we
need not address Althen prong two.
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WHITE v. HHS 5
& Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). For
the following reasons, we disagree.
I
“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). As such, we
review the special master’s factual findings under the “ar-
bitrary and capricious standard,” and we review his legal
rulings to determine whether they are “not in accordance
with law.” Id.; Lampe v. Sec’y of Health & Hum. Servs.,
219 F.3d 1357, 1360 (Fed. Cir. 2000). The “arbitrary and
capricious [standard] is a highly deferential standard of re-
view. If the special master has considered the relevant ev-
idence of record, drawn plausible inferences and
articulated a rational basis for the decision, reversible er-
ror will be extremely difficult to demonstrate.” Hines ex
rel. Sevier v. Sec’y of Dep’t of Health & Hum. Servs.,
940 F.2d 1518, 1528 (Fed. Cir. 1991) (cleaned up).
“The Vaccine Act distinguishes between so-called ‘Ta-
ble injuries,’ for which causation is presumed when a des-
ignated condition follows the administration of a
designated vaccine within a designated period of time, see
42 U.S.C. §§ 300aa-11(c), 300aa-14, and all other injuries
alleged to be caused by a vaccine, known as ‘off-Table inju-
ries,’ for which causation must be proved in each case.”
Moberly, 592 F.3d at 1321; de Bazan v. Sec’y of Health &
Hum. Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008). Thus,
for Table cases, the Vaccine Act “removes the petitioner’s
difficult burden of proving actual causation by allowing the
petitioner to rely on a table[-based] injury and a presump-
tion of causation.” Knudsen ex rel. Knudsen v. Sec’y of Dep’t
of Health & Hum. Servs., 35 F.3d 543, 547 (Fed. Cir. 1994).
And if petitioners can overcome their initial burden of es-
tablishing that presumption, “they are entitled to recover
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WHITE v. HHS 6
unless the government shows . . . by a preponderance of the
evidence[] that the injury was in fact caused by factors un-
related to the vaccine.” Id. (cleaned up); see 42 U.S.C.
§ 300aa-13(a)(1)(B).
To prove actual causation for the factor unrelated to
the vaccine, we apply the same standards that apply to a
petitioner’s proof of actual causation in fact in off-Table
cases. See Knudsen, 35 F.3d at 549 (“[T]he standards that
apply to a petitioner’s proof of actual causation in fact in
off-[T]able cases should be the same as those that apply to
the government’s proof of alternative actual causation in
fact.”). Therefore, the government must
show by preponderant evidence that the [factor un-
related] brought about [petitioner’s] injury by
providing: (1) a medical theory causally connecting
the [factor unrelated] and the injury; (2) a logical
sequence of cause and effect showing that the [fac-
tor unrelated] was the reason for the injury; and
(3) a showing of a proximate temporal relationship
between [factor unrelated] and injury.
Althen, 418 F.3d at 1278. In addition to proving causation
under Althen, the government must also establish that the
factor unrelated is the agent “principally responsible for
causing the petitioner’s illness, disability, injury, condition,
or death.” 42 U.S.C. § 300aa-13(a)(2)(B) (emphasis added).
We have described this “principally responsible for” lan-
guage as a requirement that the government “present[] suf-
ficient evidence to establish that [the factor unrelated] was
the sole substantial factor in bringing about the injury.” de
Bazan, 539 F.3d at 1354 (emphasis added).
A
White first argues that the special master erred by fail-
ing to hold the government to its burden of proof with re-
spect to causation and therefore that his findings are
arbitrary and capricious. See Appellant Br. 19–23. In
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WHITE v. HHS 7
particular, White contends that the government failed to
exclude the vaccine as causal and that the special master
overlooked that failure in assessing whether the govern-
ment had met its burden on alternative causation for the
factor unrelated. Id. at 23. In doing so, White heavily re-
lies on a Table case, Knudsen, 35 F.3d at 547. See Appel-
lant Br. at 19–23.
White’s case is distinct from Knudsen, however. Here,
unlike in Knudsen, the special master did “specifically
find” that the parties’ competing “evidence preponderated
in favor of alternative causation.” Knudsen, 35 F.3d at
550–51; compare id. (explaining that “the special master
did not specifically find” whether the evidence preponder-
ated one way or the other), with Special Master Decision,
at *17 (“[T]he record preponderantly supports [the govern-
ment’s] contention that [White’s] demonstrated H. [i]nflu-
enza[e] infection was the more likely sole substantial factor
causing [White’s] GBS . . . .”), and id. at *18, n.16 (“I con-
clude it ‘more likely than not’ that the vaccine is excluded
as causal.”).
In finding that the government had shown that the vac-
cine was not a substantial factor contributing to White’s
injury, the special master first noted that White’s expert
merely stated in “conclusory form” that “the flu vaccine was
still likely . . . a substantial factor in [White’s] injury,” id.
at *5, and that the expert relied on the vaccine being “pre-
sumed causative,” id. at *6 (citation omitted). The special
master then reviewed the relevant evidence to determine
whether the government established a factor unrelated ac-
tually caused White’s injury. Specifically, he reviewed the
medical literature and expert reports. See, e.g., id. at *17
(explaining that the “risk” of developing a GBS-related in-
jury from vaccination “is consistently deemed lesser in
comparison [to infection] (and in some studies
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WHITE v. HHS 8
unfounded).”);2 id. (explaining that in some cases “[i]t has
even been documented that vaccination might play a pro-
tective role against GBS.”).3 Based on his review of that
medical literature, the special master drew the plausible
inference that the government “has also shown that in the
general context of vaccination and infection, vaccination
will usually be less likely causal (thus helping [the govern-
ment] to exclude the vaccine in this case as part of his en-
hanced burden to show factor unrelated).” Id. at *17.
In addition to the medical literature, the special master
also reviewed White’s medical records, which “establish[ed]
that the infection . . . occurred far closer in time than vac-
cination.” Id. at *18. From that, he drew the plausible in-
ference that “[t]his medical history is not consistent with
the vaccine playing even a contributory role to [White’s]
GBS.” Id. We therefore conclude that the special master’s
decision to exclude the vaccine as a substantial causal fac-
tor is grounded in the relevant record evidence and sup-
ported by plausible inferences and thus it is not arbitrary
and capricious.
2 F. DeStefano et al., Principal Controversies in Vac-
cine Safety in the United States, CLINICAL INFECTIOUS
DISEASES 1, 4 (2019), J.A. 499–504.
3 J. Stowe et al., Investigation of the Temporal Asso-
ciation of Guillain-Barré Syndrome with Influenza Vaccine
and Influenza like Illness Using the United Kingdom Gen-
eral Practice Research Database, 169 AM. J. EPIDEMIOLOGY
OF 382, 385–86 (2008), J.A. 466–67; L. Grimaldi-Bensouda
et al., Guillain-Barré Syndrome, Influenzalike Illnesses,
and Influenza Vaccination During Seasons With and With-
out Circulating A/H1 N1 Viruses, 174 AM. J. OF
EPIDEMIOLOGY 3, 326, J.A. 473.
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WHITE v. HHS 9
B
White next argues that the special master’s findings
under the first and third prongs of Althen are arbitrary and
capricious. Regarding prong one, the government’s burden
was to show by preponderant evidence “a medical theory
causally connecting the [factor unrelated] and the injury,”
i.e., that the factor unrelated can cause the injury suffered.
Althen, 418 F.3d at 1278. White argues that the govern-
ment did not provide a “sound and reliable medical or sci-
entific explanation.” Appellant Br. 26 (citation omitted).
Specifically, he argues that the government did not offer
“sufficient evidence specific to the infection in question,
[and] how it could cause GBS.” Id. at 29 (emphasis omit-
ted). White contends that for the government to have pre-
ponderantly established Althen prong one, it “needed to
provide evidence of the biological mechanism of how the
H[.] [i]nfluenza[e] could cause GBS.” Id. We disagree.
“Althen makes clear that a claimant’s theory of causa-
tion must be supported by a ‘reputable medical or scientific
explanation.’” Andreu ex rel. Andreu v. Sec’y of Dep’t of
Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009)
(quoting Althen, 418 F.3d at 1278). Whether a theory of
causation is “reputable” can depend on the scientific evi-
dence. Id. at 1380. But medical studies and data “must be
viewed . . . not through the lens of the laboratorian, but in-
stead from the vantage point of the Vaccine Act’s prepon-
derant evidence standard,” which does not require
“scientific certainty” or disproving “every possible ground
of causation.” Id. (citation omitted); see Broekelschen v.
Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed.
Cir. 2010); Moberly, 592 F.3d at 1325; see also Lobo v. Dep’t
of Just., 139 F.4th 1311, 1317 (Fed. Cir. 2025) (noting that
“‘medical certainty’ . . . is more demanding than the pre-
ponderance standard of more likely than not”). The gov-
ernment, like a petitioner when the burden is on him, is
therefore “not required to present proof of causation to the
level of scientific certainty,” Moberly, 592 F.3d at 1324, or
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WHITE v. HHS 10
to “provide conclusive evidence in the medical literature,”
Andreu, 569 F.3d at 1377. Nor is “identification and proof
of specific biological mechanisms” required. Knudsen,
35 F.3d at 549. Rather, “causation can be found in vaccine
cases based on epidemiological evidence and the clinical
picture.” Id. (citation omitted). White’s argument is there-
fore premised on an incorrect articulation of our case law.
Moreover, White has failed to demonstrate that the
special master’s decision was arbitrary and capricious un-
der the appropriate requirements for Althen prong one.
The special master considered the relevant record evi-
dence, see, e.g., Special Master Decision, at *17 (relying on
an article stating that “[m]olecular mimicry and cross-re-
active immune responses have also been identified after
some types of preceding infection, including H. influen-
zae.”);4 id. at *7, *17 (relying on a study that determined
that six GBS patients had elevated anti-H. influenzae an-
tibodies compared with only one in normal controls, sug-
gesting an association),5 and drew plausible inferences
from said evidence, see, e.g., id. (finding that the evidence
“demonstrat[ed] an association between the risk of GBS fol-
lowing infection generally,” as well as a risk of GBS “spe-
cific to the H. influenza[e] infection.”). We therefore see no
reversible error regarding the special master’s analysis of
the first prong of Althen. See Hines, 940 F.2d at 1528 (“If
the special master has considered the relevant evidence of
record, drawn plausible inferences and articulated a ra-
tional basis for the decision, reversible error will be
4 P. van Doorn et al., Clinical Features, Pathogene-
sis, and Treatment of Guillain-Barré Syndrome, 7 LANCET
939, 941 (2008), J.A. 522.
5 Y.Y. Ju et al., Haemophilus Influenzae as a Possi-
ble Cause of Guillain-Barré Syndrome, 149 J.
NEUROIMMUNOLOGY 160, 165–66 (2004) (“Ju”), J.A. 552–
53.
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WHITE v. HHS 11
extremely difficult to demonstrate.”); see also Munn v. Sec’y
of Dep’t of Health & Hum. Servs., 970 F.2d 863, 871 (Fed.
Cir. 1992) (“[I]t is not then the role of this court to reweigh
the factual evidence, or to assess whether the special mas-
ter correctly evaluated the evidence.”).
Regarding Althen prong three, the government’s bur-
den was to show by preponderant evidence that there was
a “proximate temporal relationship between [the factor un-
related] and injury.” Althen, 418 F.3d at 1278. White ar-
gues that the “temporal association was determined,
without any evidence proffered by [the government].” Ap-
pellant Br. 35–37. He also takes issue with the special
master’s analogy to another Claims Court case finding that
12 days was a medically acceptable immune response time.
Id. at 35–36 (citing Randolph v. Sec’y of Health & Hum.
Servs., No. 15-146V, 2021 WL 5816271, at *23 (Fed. Cl.
Nov. 12, 2021)). He argues that because “the case the [spe-
cial master] relies upon does not support his conclusion,”
since the onset here is only 10 days, and because “no dis-
cussion by [the government’s] expert exists about an ‘adap-
tive immune response’ in this case,” the special master
could not “properly determine the temporal association in
this case.” Id. at 36. Once again, we disagree.
The burdened party must offer “preponderant proof
that the onset of symptoms occurred within a timeframe
for which, given the medical understanding of the disor-
der’s etiology, it is medically acceptable to infer causation-
in-fact.” de Bazan, 539 F.3d at 1352 (citing Althen,
418 F.3d at 1281 (equating “proximate temporal relation-
ship” with the phrase “medically-acceptable temporal rela-
tionship”)). White’s argument that the special master
made a finding based on “no evidence,” Appellant Br. 36, is
not accurate and mischaracterizes the special master’s de-
cision.
The special master reviewed White’s clinical course
and found that “[t]he medical records establish that the
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WHITE v. HHS 12
infection (which first manifested 10 days before [White’s]
neurologic symptoms on December 10, 2017) occurred far
closer in time than vaccination—but within a timeframe
that would be reasonable for an antibody-driven, adaptive
immune system autoimmune process to occur.” Special
Master Decision, at *18. The special master also found “no
record evidence of any close-in-time vaccine reaction.” Id.
Furthermore, the special master reviewed the relevant
medical literature offered by both experts, see id. at *6–7
(citing Ju, J.A. 547), and offered a reasoned explanation
analogizing a 12-day timeframe for an onset of symptoms
to the 10-day timeframe in this case, see id. at *18 (citing
Randolph, 2021 WL 5816271, at *23). Again, we will not
second guess the special master’s reasoned assessment of
the evidence and expert reports. See Munn, 970 F.2d at
871.
Finally, White argues that the special master erred by
using the term “likely” in describing White’s “likely infec-
tion.” Appellant Br. 35–36 (citing Special Master Decision,
at *18). He contends that “[l]ikely[] does not meet the ‘more
likely than not’ standard of proof.” Id. at 35 n.9. But White
takes the use of “likely” out of context. The special master
used the term “likely” to account for the uncertainties in-
herent in medical diagnoses, not to draw a causal compar-
ison between the infection and vaccine. That is evident
elsewhere in his decision, where he makes clear that he
found that White did have an H. influenzae infection. See
Special Master Decision, at *17 (explaining that “the med-
ical records also establish that [White’s] H. influenzae in-
fection likely ‘did cause’ his GBS”); id. (explaining that the
evidence—that White experienced a URI with a ten-day
history of symptoms, his sputum findings positive for H.
influenzae and that his chest X-ray findings showed wors-
ening lung conditions—were persuasive); id. at *8 (“[A]t
least 14 treaters associated [White’s] upper respiratory in-
fection with the development of his GBS.”). He also clearly
articulated and applied the “more likely than not” standard
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WHITE v. HHS 13
to the government’s evidence and argument. See, e.g., Spe-
cial Master Decision, at *18 n.16 (“I emphasize again: this
determination is the result of the preponderance standard.
I conclude it ‘more likely than not’ that the vaccine is ex-
cluded as causal.”).
In sum, the special master’s conclusion that “the record
preponderantly supports [the government’s] contention
that [White’s] demonstrated H. [i]nfluenza[e] infection was
the more likely sole substantial factor causing [White’s]
GBS,” id. at *17, reflects a careful review of the record evi-
dence, including the medical literature and expert reports,
and is therefore not arbitrary and capricious.
CONCLUSION
We have considered White’s remaining arguments and
find them unpersuasive. For the foregoing reasons, we con-
clude that the special master’s decision is in accordance
with the law and his findings are not arbitrary and capri-
cious. Accordingly, we affirm the Claims Court’s upholding
of the special master’s denial of White’s claim for compen-
sation under the Vaccine Act.
AFFIRMED
COSTS
No costs.
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