Case: 19-1753 Document: 32 Page: 1 Filed: 04/07/2020
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
TRYSTAN SANCHEZ, BY AND THROUGH HIS
PARENTS, GERMAIN SANCHEZ, JENNIFER
SANCHEZ,
Petitioners-Appellants
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee
______________________
2019-1753
______________________
Appeal from the United States Court of Federal Claims
in No. 1:11-vv-00685-PEC, Judge Patricia E. Campbell-
Smith.
______________________
Decided: April 7, 2020
______________________
LISA A. ROQUEMORE, Law Offices of Lisa A. Roquemore,
Rancho Santa Margarita, CA, argued for petitioners-appel-
lants.
HEATHER LYNN PEARLMAN, Vaccine/Torts Branch, Civil
Division, United States Department of Justice, Washing-
ton, DC, argued for respondent-appellee. Also represented
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2 SANCHEZ v. HHS
by JOSEPH H. HUNT, C. SALVATORE D'ALESSIO, CATHARINE
E. REEVES, JENNIFER LEIGH REYNAUD.
______________________
Before NEWMAN, BRYSON, and REYNA, Circuit Judges.
BRYSON, Circuit Judge.
This is an appeal from a decision of the Court of Fed-
eral Claims (“the Claims Court”) reviewing the decision of
a special master denying a petition for compensation under
the National Vaccine Injury Compensation Program (“the
Vaccine Act”), 42 U.S.C. § 300aa-10 et seq. Sanchez v. Sec’y
of Health & Human Servs., 142 Fed. Cl. 247 (2019). The
parties, the special master, and the Claims Court judge
have all put enormous time and thoughtful attention into
this complex and difficult case. For that reason, it is with
reluctance that we have come to the conclusion that it is
necessary to burden the parties and the adjudicators with
additional work. Nonetheless, because the record has left
certain critical issues unresolved, we are required to vacate
the judgment and remand for further proceedings.
I
A
Trystan Sanchez received several vaccines in February
2009 when he was six months old. Shortly after his vac-
cinations, he developed a fever and displayed what his par-
ents characterized as “inconsolable crying.” Several days
later, he again developed a fever and was congested. He
was diagnosed at that time with a common cold.
In August 2009 Trystan received a second round of vac-
cinations. Trystan’s mother reported at that time that she
had noticed a change in Trystan’s development. A neurol-
ogist who saw Trystan in November 2009 determined that
he was exhibiting global developmental delays. Trystan
continued to show developmental delays for the next sev-
eral years.
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SANCHEZ v. HHS 3
In 2011, suspecting that the 2009 vaccinations had
been responsible for Trystan’s developmental difficulties,
the Sanchezes filed a petition for compensation under the
Vaccine Act. While the petition was pending, Trystan un-
derwent genetic testing. Based on two mutations in
Trystan’s DNA discovered during that testing, Trystan was
diagnosed with Leigh’s syndrome. Leigh’s syndrome is a
rare but severe genetic disorder that typically manifests it-
self in the first year of life and causes progressive loss of
mental and physical abilities, usually resulting in early
death.
B
Prior to Trystan’s genetic testing and his Leigh’s syn-
drome diagnosis, the special master who was assigned to
the case held a hearing to determine the facts relating to
Trystan’s condition. Based on the evidence at the hearing
and the parties’ joint statement of stipulated facts, the spe-
cial master then entered a detailed Ruling Finding Facts
in April 2013. In several instances in his factual findings,
the special master chose to credit the written medical re-
ports’ descriptions of Trystan’s symptoms over the testi-
mony of Trystan’s parents.
The special master found that Trystan appeared
healthy and was developing normally before February 5,
2009, when he received his first round of vaccines. Shortly
after his pediatric visit that day, however, Trystan began
to cry inconsolably, he ran a temperature of 102.2, and he
developed a lump on his left thigh that was hot to the touch.
The fever ebbed and flowed over the next several days.
On February 15, Trystan became congested and began
running a fever again. The following night, his fever be-
came worse, and he began what his mother described as
“loud, high-pitched” crying. His father sought to calm
Trystan by holding him, but when Trystan would fall
asleep, he would repeatedly startle awake. According to
his father, Trystan “kept kicking his feet and jerking
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4 SANCHEZ v. HHS
around” in his father’s arms, “almost as if he didn’t want to
be held.” His father testified that Trystan was “jerking his
body” and “holding his arm behind his back kind of in an
uncomfortable position.” Trystan’s father said that when
he “went to put [Trystan’s] arm back to the normal posi-
tion,” he could “feel that he had a lot of tension in that arm.
And when I did put it back, his arm went right back holding
it back towards the back of his body.” In his 2013 Ruling
Finding Facts, the special master did not appear to credit
Trystan’s father’s testimony regarding Trystan’s arm
movements. In that ruling, the special master said that
“[a]t this time, Trystan did not begin to exhibit arm contor-
tions.”
The following morning, Trystan’s mother took Trystan
to the pediatrician’s office, where he was examined by Jon-
athan P. Luna, a certified physician’s assistant. Mr. Luna
diagnosed Trystan with a “common cold” and “viral syn-
drome.” Ms. Sanchez testified that she told Mr. Luna about
Trystan’s arm contortions, but Mr. Luna did not make a
note of her observations in his record of the visit. In light
of the absence of a report of the arm contortions in Mr.
Luna’s record of the visit, the special master found that
Trystan did not begin to exhibit arm contortions at that
time.
Trystan suffered from coughing and congestion episod-
ically for the next couple of months. Ms. Sanchez testified
that during that period, Trystan continued to have arm
contortions, sometimes several times a day. In addition,
she testified that Trystan “started to lose control of his
head,” that his “trunk . . . was not as strong,” that he “didn’t
have any eye contact,” and that he “didn’t want to play”
anymore. Again, however, the special master did not credit
Ms. Sanchez’s testimony because it was not corroborated
by medical reports.
On April 29, 2009, after Trystan had suffered from a
cough and congestion for two weeks, his mother took him
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SANCHEZ v. HHS 5
to a pediatrician, Dr. Nabil R. Seleem. She testified that
she told Dr. Seleem about Trystan’s arm contortions. Dr.
Seleem, however, did not note any such comments in his
record of the visit, and his notes reflect his observation that
Trystan appeared to be neurologically normal. Based on
Dr. Seleem’s report, the special master found that Ms.
Sanchez did not report any “unusual arm movements or
developmental issues” to Dr. Seleem. Dr. Seleem diag-
nosed Trystan with an ear infection and bronchitis, for
which he prescribed an antibiotic.
Trystan returned to the clinic on May 13, 2009, at
which time the examining pediatrician, Dr. Philip S.
Brown, noted that Trystan’s infection seemed to be resolv-
ing. Ms. Sanchez testified that she told Dr. Brown about
“the weird movement, the contortion of the arm,” and the
issue with Trystan’s head control. Dr. Brown’s report of
the visit did not include any reference to those neurological
complaints, however, and the special master found that
Trystan had not experienced any loss of skills at that point.
On August 17, 2009, Trystan was seen by physician’s
assistant Micaela Marin-Tucker for his one-year well-baby
exam. Ms. Marin-Tucker’s notes reflect that Trystan’s
mother said she had noticed a change in Trystan’s develop-
ment about two to three months earlier. Ms. Sanchez tes-
tified that Ms. Marin-Tucker’s notes were wrong and that
she told Ms. Marin-Tucker she had noticed a change in
Trystan’s development that began five to six months ear-
lier. The special master credited Ms. Marin-Tucker’s con-
temporary notes over Ms. Sanchez’s testimony and found
that Trystan began to lose skills only as of about the begin-
ning of May 2009 at the earliest.
In the course of her examination, Ms. Marin-Tucker
found that Trystan did not walk, stand, crawl, and hold his
head up while sitting. She also found that Trystan did not
attempt to move his lower extremities, and she noticed that
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6 SANCHEZ v. HHS
his extremities seemed generally soft, but rigid at times.
Ms. Marin-Tucker referred Trystan to a neurologist.
During the August 2009 clinic visit, Trystan received
another round of vaccinations. Following those vaccina-
tions, Ms. Sanchez testified, Trystan “got sick again” and
“started contorting his arm even more.”
Six weeks later, Trystan returned to the clinic for a fol-
low-up visit. At that time, Ms. Marin-Tucker noted that
Trystan had “no seizures, weakness, or tics.” In the report
of her neurological examination, however, she stated that
Trystan was “unable to grasp, sit, crawl, or make much eye
contact.” She again urged the family to have Trystan ex-
amined by a neurologist.
In November of that year, Trystan was seen by a neu-
rologist. Prior to that visit, Trystan began having tremors
or twitching of his whole body. The neurologist recorded
reports that Trystan was unable to sit independently, his
hands stayed closed, and his feet went forward when he
was at rest. His examination was positive for muscle
spasms, weakness, and global developmental delay, among
other problems. Based on his examination and Trystan’s
history, the neurologist concluded that Trystan was suffer-
ing from “global developmental delay of unclear etiology,
though a genetic predisposition is suspected based on the
family history and a [central nervous system] cause is sug-
gested by the physical exam findings.” An MRI performed
in December 2009 revealed abnormalities in Trystan’s ba-
sal ganglia, and the treating physicians began to suspect a
metabolic disorder.
During the ensuing five years, Trystan was examined
on numerous occasions, without a firm diagnosis being
reached. Genetic testing in December 2014, over a year af-
ter the special master’s initial factual findings, revealed
that Trystan had two mutations in his SDHA gene. Based
on those mutations, Trystan’s treating physician confirmed
a diagnosis of Leigh’s syndrome.
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SANCHEZ v. HHS 7
C
Following Trystan’s diagnosis with Leigh’s syndrome,
the petitioners’ theory changed. Rather than arguing that
the vaccines directly caused his condition, they acknowl-
edged that Trystan’s Leigh’s syndrome was the product of
his genetic condition. They argued, however, that the first
round of vaccinations Trystan received on February 5,
2009, either caused his genetic condition to be expressed or
significantly aggravated the course of his disease. They
also argued that Trystan’s second set of vaccinations, on
August 17, 2009, further aggravated the effects of his dis-
ease.
To address these issues, the special master held a sec-
ond hearing in December 2017 at which experts for the par-
ties testified. At that four-day hearing, two experts
testified for the petitioners—Dr. Lawrence Steinman and
Dr. Dmitriy Niyazov. Four experts testified for the govern-
ment—Dr. Gerald Raymond, Dr. Stephen McGeady, Dr.
Edward Cetaruk, and Dr. Dean Jones.
The petitioners’ experts testified that Trystan’s devel-
opmental regression began shortly after his first vaccina-
tions on February 5, 2009. Dr. Niyazov testified that the
symptoms Trystan experienced immediately after receiv-
ing those vaccines were evidence of an immune response.
Because of Trystan’s genetic mutations, which resulted in
decreased mitochondrial function, the vaccines started an
inflammatory response affecting Trystan’s brain. That re-
sponse, according to Dr. Niyazov, “triggered a gradual pro-
cess of developmental regression” that became more
evident around June 1, 2009.
Dr. Steinman similarly testified that the vaccines
stressed the energy sources in Trystan’s cells. Because of
Trystan’s mitochondrial disease, Dr. Steinman testified,
Trystan was “on the edge all the time, and this vaccine trig-
ger[ed] a downward cascade that began on February 5th
when he got the vaccine.” Dr. Steinman and Dr. Niyazov
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8 SANCHEZ v. HHS
testified that Trystan’s inconsolable high-pitched crying
and his jerking and arm contortions were evidence of neu-
rodegenerative events, and were not consistent with a com-
mon cold.
Drs. Niyazov and Steinman also testified that Trystan
suffered what is known as a “challenge-rechallenge.” That
is, his regression and dystonia following his initial vaccina-
tions was repeated following his August 2009 vaccinations,
except that his condition worsened significantly after that
time. Dr. Steinman referred to the aftermath of Trystan’s
second set of vaccines as “an accelerated neurological de-
generation due to a recall response.” Dr. Niyazov agreed
that the second set of vaccinations set Trystan back again.
One of the government’s experts, Dr. McGeady, testi-
fied that while Trystan’s inconsolable crying on the day of
his initial vaccinations “may very well have been” a re-
sponse to the vaccines, the fever that he ran on February
16, 2009, was caused by the viral respiratory infection he
suffered at that time. The other principal government ex-
pert, Dr. Raymond, testified that in his opinion, the evi-
dence did not show that Trystan had a seizure on February
16. Instead, he testified that “[k]icking of the legs, resist-
ing being held, is not, in my opinion, epileptic activity.”
Following the December 2017 hearing, the special ma-
ter entered his Published Decision Denying Compensation.
In that detailed order, he reviewed his earlier factual find-
ings and then turned to deciding the issue of compensation
in light of the expert evidence adduced at the second hear-
ing.
At the outset, the special master addressed the first of
the three factors to be considered in assessing a vaccine
compensation claim under this court’s decision in Althen v.
Secretary of Health & Human Services, 418 F.3d 1274,
1278 (Fed. Cir. 2005): whether the petitioners have shown
“a medical theory causally connecting the vaccination and
the injury.” In this case, that factor required the special
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SANCHEZ v. HHS 9
master to determine whether the petitioners had shown
that the vaccines Trystan received could have caused the
manifestation or aggravation of his Leigh’s syndrome.
After reviewing the expert testimony and the medical
literature, the special master concluded that “though a link
between vaccination and the onset of Leigh’s syndrome has
not been established to the standard of medical certainty,”
the evidence presented was “sufficient to conclude that the
Sanchezes’ theory is plausible insofar as it is consistent
with contemporary understanding of the biological systems
at play.” The special master explained that the “first man-
ifestation of Leigh’s syndrome is known to follow an inter-
current illness in many, if not most, cases.” In particular,
the special master concluded that the Sanchezes had pre-
sented “a plausible medical theory explaining how
Trystan’s vaccines may have caused his injury” by showing
that it was more plausible than not that the vaccine that
Trystan received “is known to sometimes cause fever,” and
that “fever can cause decompensation in someone with a
pre-existing mitochondrial disease.” 1 In light of the evi-
dence before him, the special master concluded that the
government had not rebutted either of those theories, and
“that both premises are likely to be consistent with contem-
porary medical thought.”
The special master then turned to the question
whether the vaccine had in fact triggered or aggravated
Trystan’s Leigh’s syndrome, for which his genetic muta-
tions predisposed him. The special master noted that the
petitioners and their experts argued that Trystan’s neuro-
logical deterioration began on February 5, 2009, the day he
received his vaccinations. The special master concluded,
however, that the evidentiary record “does not support this
1 As the special master explained, “decompensation” is
a period of regression or loss of skills frequently seen in
children with Leigh’s syndrome.
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10 SANCHEZ v. HHS
premise that is so central to the Sanchezes’ argument.” In-
stead, the special master found that “approximately three
months passed between when Trystan received the Febru-
ary 5, 2009 vaccinations and the earliest possible onset of
his neurological regression.” Based on that finding, the
special master asked whether a delay of that magnitude “is
consistent with vaccine-causation.” In light of the medical
literature in evidence, he concluded that it was not. In-
stead, summarizing the literature, the special master con-
cluded that regression would generally be expected to occur
in such patients within about two weeks or less after the
triggering event, such as a fever or infection.
The special master made a series of factual findings
bearing on the issue. In particular, he found that in the
hours after the February 5 vaccination, Trystan developed
a fever and displayed inconsolable crying. The fever ebbed
and flowed for a few days.
The special master found that the vaccines Trystan
was given on February 5 caused him to develop a fever. He
also found that fever, including fever following vaccination,
can cause decompensation in a patient with a metabolic
disease such as Trystan’s.
On February 15, Trystan developed another fever and
was crying inconsolably again. He “was congested and had
difficulty breathing.” In addition, the special master found,
Trystan’s “arms contorted and he was jerking around.”
However, the special master found that those movements
“were of the type typically displayed by an infant suffering
from a cold.” The special master also found that Trystan’s
family did not convey to physician’s assistant Luna, who
examined Trystan the following day, that Trystan had dis-
played any symptoms consistent with a neurological injury
as opposed to a cold, and Mr. Luna did not detect any signs
in the course of his examination that were consistent with
a neurological injury as opposed to a cold.
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SANCHEZ v. HHS 11
The special master also found that Trystan’s parents
took him to see Dr. Seleem on April 29, 2009, because of
concern about his cough and congestion that had lasted for
two weeks, and that they did not convey to Dr. Seleem that
Trystan had displayed any symptoms consistent with a
neurological injury. The special master further found that
Dr. Seleem did not observe any signs that were indicative
of neurological injury during the examination he performed
on Trystan.
Finally, the special master credited the report pre-
pared by physician’s assistant Marin-Tucker, who stated
that Trystan’s mother had said during the August 17, 2009,
visit that Trystan first started showing signs of loss of
skills approximately two to three months earlier. Based on
that evidence, the special master concluded that the first
signs of Trystan’s loss of skills occurred by the beginning of
May 2009 at the earliest.
The special master then addressed the question
whether the delay between the date of the vaccinations and
when Trystan’s parents noticed his loss of skills was at-
tributable to the fact that in a child as young as Trystan,
the loss of skills may not be immediately obvious. Based
on the literature, the special master found that “there is
some truth to that claim.” In addition, the special master
deemed that there is “a non-insignificant chance that the
Sanchezes relayed a concern [about Trystan’s develop-
ment] at the May 13, 2009, visit with Dr. Brown that did
not end up in the records.” Nonetheless, the special master
concluded, that possibility did not account for the three-
month period during which the medical records “show[ed]
no indication of Trystan having, or the parents being con-
cerned about, a neurological condition.” Instead, the spe-
cial master found, the parents “appeared to be focused on
Trystan’s multiple colds.”
The special master acknowledged that “if Trystan did
not experience any other decompensating events between
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12 SANCHEZ v. HHS
the vaccination and the onset of his Leigh’s syndrome, it
may very well make his parents’ claims of causation less
improbable.” However, the special master pointed out that
during the three months “leading up to when his loss of
skills first manifested, Trystan suffered from multiple up-
per respiratory infections.” Such infections, the special
master noted, “are known to precipitate mitochondrial de-
compensation.” Trystan’s upper respiratory infections be-
tween March and May of 2009, the special master
concluded, “are entirely consistent with the infections be-
ing the intercurrent infection that induced his metabolic
decompensation . . . .”
The special master further stated that the petitioners’
failure to address “a conspicuous and probable alternate
cause for the manifestation of Trystan’s Leigh’s syndrome
weighs against a finding that the vaccination caused
Trystan’s injury.” He determined that the presence of a
probable alternative cause, “in combination with the un-
likelihood of a multiple-month delay between the vaccine
and the onset of his neurodegeneration, makes a finding
that the vaccine was, more likely than not, a substantial
factor in Trystan’s Leigh’s syndrome untenable.” The spe-
cial master therefore denied the petition for compensation.
D
The petitioners filed a motion for review of the special
master’s decision with the Claims Court. After conducting
a detailed review of the evidence and the special master’s
findings, the court upheld the special master’s decision
denying compensation.
The Claims Court rejected petitioners’ contention that
the special master had erred in finding that Trystan’s vac-
cine-related injury occurred within an acceptable time
frame. The court declined the petitioners’ “invitation to re-
weigh the evidence as to disease onset,” because nothing in
the allegations of fact or the expert opinions relied on by
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SANCHEZ v. HHS 13
the petitioners showed that the special master’s findings as
to disease onset were arbitrary or capricious.
The Claims Court also rejected the petitioners’ argu-
ment that the special master had ignored their “challenge-
rechallenge” argument based on the combined effect of the
February and August 2009 vaccinations. The court found
that the special master had “weighed the relevant evidence
of rechallenge symptoms” but “found the evidence to be un-
persuasive.” For that reason, the court concluded, “it was
not error for the special master to also find petitioners’ ex-
pert testimony as to rechallenge to be so unpersuasive as
to be unworthy of mention . . . .”
II
On appeal, the petitioners challenge the special mas-
ter’s decision (and the Claims Court’s affirmance of that
decision) on three principal grounds. First, the petitioners
contend that the rulings of the special master and the
Claims Court are contrary to the 2015 decision of this court
in Paluck v. Secretary of Health & Human Services, 786
F.3d 1373 (Fed. Cir. 2015). Second, they argue that the
central component of the special master’s ruling—that
Trystan’s Leigh’s syndrome was not triggered by his Feb-
ruary 5, 2009, vaccinations—is contrary to the evidence.
Third, they argue that the special master failed to address
their “challenge-rechallenge” argument, i.e., their conten-
tion that the combination of the first vaccination in Febru-
ary 2009, and the second vaccination, in August 2009,
triggered or aggravated Trystan’s condition.
We are mindful that our authority to review factual
findings made by the special master is extremely limited.
As this court explained in Paluck, 786 F.3d at 1378, “we
review findings of fact under the arbitrary and capricious
standard.” See also Porter v. Sec’y of Health & Human
Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011).
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14 SANCHEZ v. HHS
A
In Paluck, we affirmed the Claims Court’s decision
overturning a special master’s denial of compensation to
Vaccine Act claimants in circumstances similar in several
respects to this case. We agree with the petitioners that
this case has some features in common with Paluck, and
that this court’s analysis in Paluck provides helpful guid-
ance for the analysis of the merits of the petitioners’ claims
in this case.
Like this case, Paluck involved a child with a mitochon-
drial disorder. And, as in this case, the evidence in Paluck
showed that vaccines can activate the immune system,
which in an individual with a mitochondrial disease can
result in oxidative stress that can, in turn, cause progres-
sive neurological deterioration over time. See Paluck, 786
F.3d at 1380–81. In fact, several of the scientific papers
that the courts in Paluck pointed to as supporting the
Palucks’ theory of liability were introduced by the
Sanchezes in this case.
While there are similarities between this case and
Paluck, there are differences as well, and because of those
differences, this case cannot be decided based on Paluck
alone. In particular, the Claims Court in Paluck rejected
the special master’s conclusion that the child’s post-vac-
cination deterioration did not align with the medical theory
on which the petitioners relied, in that the regression was
not “linear” and the child did not manifest identifiable
symptoms of neurologic injury within three weeks of his
vaccinations. The court sustained the Claims Court’s rul-
ing that the special master’s decision was arbitrary and ca-
pricious in that respect; the Claims Court held that the
special master disregarded significant probative evidence
that the child “experienced rapid and progressive neurolog-
ical deterioration within a medically acceptable interval
following his vaccinations.” 786 F.3d at 1380. In light of
the “compelling evidence of post-vaccination neuro-
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SANCHEZ v. HHS 15
developmental regression,” this court concluded that the
special master had “no reasonable basis for concluding that
[the child] did not experience the progressive neurodegen-
eration predicted” by the petitioners’ medical theory. Id. at
1382.
This court in Paluck also concluded that the special
master had erred by “setting a hard and fast deadline of
three weeks between vaccination and the onset of clinically
apparent symptoms of neurological injury,” which the court
found was not supported by the medical literature in evi-
dence. Id. at 1382–83. The court also found several of the
inferences from the evidence drawn by the special master
to be unsupported, and it concluded that the special master
had improperly disregarded MRI evidence indicating pro-
gressive neurodegeneration and contemporaneous state-
ments from the child’s treating physicians. Id. at 1384–86.
In this case, unlike in Paluck, the special master did
not adopt a strict time limit or a requirement of “linearity”
for the manifestation of signs of Trystan’s neurological re-
gression. Instead, the special master considered the period
of time, together with the other evidence of the progression
of Trystan’s disease, in attempting to determine the issue
of causation. Nor did the special master draw the improper
inferences noted by this court in Paluck or disregard med-
ical evidence or the observations of the treating physicians.
In fact, the special master in this case relied heavily on the
observations (or the absence of observations) by the treat-
ing physicians in determining whether to credit the testi-
mony given by Trystan’s parents. In sum, while there are
substantial parallels between this case and Paluck, the dif-
ferences between the two cases are such that the outcome
of this case is not dictated by Paluck.
B
We next turn to the petitioners’ challenge to the special
master’s causation analysis. That issue requires a close ex-
amination of the evidence in the record.
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16 SANCHEZ v. HHS
The special master found the vaccines Trystan received
on February 5, 2009, are known to cause fever, and fever
can cause neural decompensation in someone with a preex-
isting mitochondrial disease. The special master concluded
that Trystan clearly suffered a loss of skills after receiving
the vaccine, and that the loss of skills was the manifesta-
tion of his Leigh’s syndrome. The critical finding made by
the special master as to the effect of the vaccination, how-
ever, was that the period of time between the vaccinations
in February 2009 and Trystan’s loss of skills no earlier
than May 2009 was too long for the vaccinations to have
been the likely trigger for his Leigh’s syndrome. It is that
finding that is the principal focus of the petitioners’ chal-
lenge to the special master’s ruling.
In support of their argument on causation, the petition-
ers point to testimony from their experts that Trystan’s fe-
ver and inconsolable crying were evidence of the onset of
neurodegeneration, and that Trystan’s arm contortions on
February 16, 2009, only 11 days after his vaccinations,
were also indicative that he had suffered an adverse neu-
rological event.
The special master rejected that argument, in large
part because he concluded that Trystan was diagnosed
with a cold on February 17, and that his symptoms the
night before were of the type typically displayed by infants
suffering from a cold. The petitioners do not challenge the
finding that Trystan was suffering from a cold, but they
contend that the evidence shows that he was also suffering
from a neurological injury at that time. In particular, the
petitioners dispute the special master’s finding that
Trystan’s symptoms—his arm contortions in particular—
were symptoms of a cold. That finding, they contend, is
wholly lacking in record support.
Analyzing this issue is complicated by the manner in
which the special master made factual findings relating to
the events of February 16, 2009. In his 2013 Ruling
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SANCHEZ v. HHS 17
Finding Facts, the special master found that although
Trystan “kept kicking his feet and jerking around” in his
father’s arms on that evening, he “did not begin to exhibit
arm contortions” at that time, and he “did not exhibit arm
contortions” between that time and the time Ms. Sanchez
took him to the doctor in late April 2009. In the 2018 Pub-
lished Decision Denying Compensation, however, the spe-
cial master found that on that evening, Trystan’s “arms
contorted and he was jerking around.”
That discrepancy is significant. The government’s ex-
pert witnesses, testifying based on the special master’s
2013 findings, said that the symptoms exhibited by
Trystan on the night of February 16, 2009—inconsolable,
high-pitched crying and “jerking around” in his father’s
arms—were consistent with a cold and were not indicative
of a seizure. However, the government’s witnesses did not
have before them the special master’s later finding that
Trystan’s arm contortions began as early as February 16.
Moreover, if the special master’s 2018 finding was based on
the testimony of Trystan’s father, it seems plausible that
Mr. Sanchez’s testimony—that Trystan repeatedly held his
arm behind his back and kept returning it to that posi-
tion—could be regarded as evidence of a seizure or dysto-
nia, as the petitioners’ expert Dr. Steinman testified. And
a seizure or dystonia at that time, Dr. Steinman testified,
“could be evidence of brain damage.”
Importantly, because of the change in the findings
made with respect to the arm contortions, the special mas-
ter’s finding that Trystan’s behavior on the night of Febru-
ary 16 was consistent with a cold is not supported by expert
testimony that specifically addressed the arm contortions.
Because this issue is of central importance to the causation
analysis, it is necessary to remand for further considera-
tion of the causation issue in light of the special master’s
findings in 2018 regarding Trystan’s arm contortions.
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18 SANCHEZ v. HHS
A related issue that the special master should consider
on remand has to do with the application of the second and
third Althen factors: “(2) a logical sequence of cause and ef-
fect showing that the vaccination was the reason for the
injury, and (3) a showing of a proximate temporal relation-
ship between vaccination and injury.” Althen, 418 F.3d at
1278. The special master treated those two factors to-
gether as being directed to the single issue of causation, on
which the petitioners bore the burden of proof. While it is
true that the entire Althen test is generally directed to the
issue of causation, Althen distinguishes between the three
factors that are necessary to make out a prima facie case
(on which the petitioners bear the burden of proof) and the
question whether the injury was caused by factors unre-
lated to the vaccine (on which the government bears the
burden of proof). If petitioners make a prima facie case un-
der the first three factors, they are entitled to prevail un-
less the government shows, by a preponderance of the
evidence, that the injury was in fact caused by factors un-
related to the vaccine. Althen, 418 F.3d at 1278; see
Shalala v. Whitecotton, 514 U.S. 268, 270–71 (1995); 42
U.S.C. § 300aa-13(a)(1)(B).
In this case, there is no question that Trystan suffered
neurodegeneration beginning no later than May or June of
2009. But for the cold he suffered on February 16, 2009,
and the other infections he suffered during the spring of
that year, the vaccinations might have been prime suspects
as the triggering mechanism for his mitochondrial disease
to manifest itself. To be sure, there was a several-month
delay between the initial vaccines and the time the special
master found that Trystan’s loss of skills began to be no-
ticed. But that delay, by itself, was not necessarily dispos-
itive. As the special master noted, there is some force to
the point that in a child as young as Trystan, loss of skills
would not be immediately noticed.
For that reason, it is important for the special master
to make explicit findings as to two separate issues: (1)
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SANCHEZ v. HHS 19
whether there was a logical sequence of cause and effect
linking Trystan’s vaccinations and his injuries as well as a
proximate temporal relationship between the vaccinations
and the onset of the injuries; and (2) whether Trystan’s in-
fections between February and May of 2009 caused the
manifestation of his Leigh’s syndrome, independent of his
vaccinations. If the special master finds that the petition-
ers have not met their burden as to the first issue, it is un-
necessary for the special master to address the second
issue. But if the special master finds that the petitioners
have met their burden of establishing a prima facie case as
to the first issue, he must determine whether the govern-
ment has met its burden as to the second.
C
The petitioners also contend that the special master
did not address the “challenge/rechallenge” claim raised by
the petitioners’ experts. That theory of causation was that
the combined effect of the February and August vaccina-
tions caused or aggravated Trystan’s condition. Although
that issue was raised in the petitioners’ pre-hearing brief
and by the evidence, the special master did not address
that theory in his Published Decision Denying Compensa-
tion.
On review of the special master’s ruling, the Claims
Court held that it was not necessary for the special master
to address that issue expressly, in that the argument ap-
peared to have been implicitly rejected in the special mas-
ter’s factual findings. However, the findings that the
special master made in his Ruling Finding Facts predated
the testimony of the petitioners’ experts, much of which fo-
cused on the challenge/rechallenge theory. Moreover, the
special master based his factual conclusion that Trystan’s
condition did not deteriorate after the August 2009 vac-
cinations on the fact that the contemporaneous medical
records did not corroborate the Sanchezes’ testimony to
that effect. The record closest in time to the August
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20 SANCHEZ v. HHS
vaccinations was the record prepared by Ms. Marin-Tucker
regarding the August 17, 2009, visit when Trystan received
his vaccinations. Based on that report the special master
found that Trystan could not stand, walk, crawl, or hold his
head up while sitting.
Six weeks later, when Trystan returned to the clinic for
a follow-up visit. Based on Ms. Marin-Tucker’s report for
that visit, the special master found that Trystan was “un-
able to grasp, sit, crawl, or make much eye contact.” While
the two medical reports are generally similar, the special
master’s findings with regard to the two reports suggest
that Trystan may have suffered at least some additional
loss of skills during the period between August and October
2009, an issue the special master did not expressly address.
The challenge/rechallenge theory is not frivolous, and
does not appear to have been implicitly rejected. For those
reasons, we conclude that the special master should ad-
dress that theory expressly on remand and decide whether
it supports compensation in this case.
D
Finally, it may be necessary for the special master to
address a question that was left open in the last two pages
of the special master’s decision denying compensation:
whether the Secretary showed, because of Trystan’s muta-
tions, the timing and severity of his Leigh’s syndrome
would have been the same, regardless of the effect of the
vaccinations.
This is a difficult issue on which the science has been
developing rapidly. Each party’s experts testified on this
issue at the December 2017 hearing. In light of the speed
with which medical understanding of the course of genetic
disorders such as Leigh’s syndrome has been expanding,
however, the special master on remand may wish to give
the parties an opportunity to supplement the record with
any relevant medical research or reports postdating the
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SANCHEZ v. HHS 21
hearing held by the special master two and one-half years
ago.
For the reasons given, we vacate the judgment in this
case and remand for further proceedings consistent with
this opinion.
No costs.
VACATED AND REMANDED