# Sanchez v. Secretary of Health and Human Services

> United States Court of Federal Claims · September 22, 2020

URL: https://www.frixlaw.com/law-library/cases/4567817

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** September 22, 2020
- **Precedential status:** Unpublished
- **Opinion:** Opinion
- **Judges:** Christian J. Moran
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/4567817

## How later opinions describe it (automated extraction)

- noting that petitioners’ burden is to provide a “viable medical theory by which a vaccine can cause the injury claimed by the petitioner”
- reversing special master's decision that petitioners were not entitled to compensation
- noting that the Vaccine Act requires a special master to consider all relevant medical and scientific evidence of record
- rejecting “proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and injury” as the applicable statutory standard

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS

*********************
TRYSTAN SANCHEZ, by and *
through his parents, GERMAIN * No. 11-685V
SANCHEZ and JENNIFER * Special Master Christian J. Moran
SANCHEZ, *
* Filed: August 26, 2020
Petitioners, *
v. * Entitlement; DTaP; Leigh’s
* syndrome; mitochondrial disorder;
SECRETARY OF HEALTH * decompensation;
AND HUMAN SERVICES, * genetic mutation; SDHA; remand
*
Respondent. *
*********************
Lisa A. Roquemore, Law Offices of Lisa A. Roquemore, Rancho Santa Margarita,
CA, for petitioners;
Jennifer L. Reynaud, United States Dep’t of Justice, Washington, DC, for
respondent.

PUBLISHED DECISION ON REMAND DENYING COMPENSATION 1

Following an October 9, 2018 decision by the undersigned special master
and a February 11, 2019 Opinion and Order by the Court of Federal Claims, the
Federal Circuit vacated the February 11, 2019 judgment and remanded for
additional consideration. The undersigned, as the Federal Circuit instructed, has

1
Because this decision contains a reasoned explanation for the action in this case, the
undersigned is required to post it on the United States Court of Federal Claims' website in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal
Management and Promotion of Electronic Government Services). This means the decision will
be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b),
petitioners have 14 days to identify and move to redact medical or other information, the
disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the
undersigned agrees that the identified material fits within this definition, the undersigned will
redact such material before posting the decision.
considered the parties’ new evidence and arguments as well as reconsidered the
parties’ old evidence and arguments. The undersigned finds that the Sanchezes are
not entitled to compensation on their claim that the vaccinations their son, Trystan,
received at six-months caused or significantly aggravated his Leigh’s syndrome.

The denial of compensation rests upon two independent grounds. First, the
evidence shows that Trystan did not experience neurologic deterioration until
many weeks after his six-months vaccination. This passage of time in which
Trystan appeared neurologically normal exculpates the vaccinations. Second, the
Secretary has carried his burden of demonstrating that two genetic mutations solely
caused Trystan’s Leigh’s syndrome.

I. Overview of Events in Trystan’s Life

Trystan was born in August 2008, but a critical event happened before he
was born. When he was conceived, he inherited from his father a mutation in a
gene known as an SDHA gene. Coincidentally, he inherited from his mother a
different mutation in the SDHA gene. However, these mutations were not detected
for many years. In the litigation, the parties dispute the consequences of these
mutations.

After Trystan was born, he received relatively little medical care for his first
six months. At the age of six-months, on February 5, 2009, Trystan was seen by a
pediatrician who found Trystan to be developing normally. In this appointment,
Trystan received a series of vaccinations including a dose of the diptheria-tetanus-
acellular pertussis (DTaP) vaccination.

On the day and evening following the vaccination, Trystan cried
inconsolably. He also had a hot red mark on his thigh, and developed a fever that
ebbed and flowed for a few days.

On February 16, 2009, Trystan was suffering from a common cold. In the
course of this illness, he was congested, had a fever, and jerked around in his
father’s arms. Trystan also contorted his arms.

Trystan had more colds for which his parents brought him to a pediatrician
at the end of April 2009 and in May 2009. During this time, Trystan began to lose
some developmental skills.

Trystan’s parents brought him for medical attention in August 2009. During
this appointment, a physician’s assistant noticed his lack of development and
2
referred him to additional medical services. This referral eventually led to an
appointment with a neurologist, who also documented problems with Trystan.

For many years, the precise nature of Trystan’s illness eluded the doctors
who treated him. Eventually, he was diagnosed with Leigh’s syndrome. “Leigh
Syndrome usually refers to a severe neurological disorder that often presents in the
first year of life and is characterized by progressive loss of mental and movement
abilities and typically results in death within a couple years.” Exhibit 140 (report
of Dr. Haas) at 5. A genetic test revealed the mutations with which he was born.

Trystan, today, is developmentally delayed. Specifically, he is described as
“[g]lobally delayed but metabolically stable” and experiencing a seizure disorder,
muscle hypotonia, and failure to thrive over the past 2-3 years. See exhibit 181 at
2, 10, 23 (Dr. Haas). His condition reflects a child with Leigh’s syndrome.

The foregoing summary is intended to provide a general overview about
Trystan’s life. Additional details are discussed in the context of evaluating the
parties’ arguments as to whether the DTaP vaccination harmed Trystan. See
section VII (Althen prong 2) below.

II. Procedural History

This case has had four different phases. The case began at the Office of
Special Masters (part A below). After a decision denying entitlement, the
Sanchezes filed a motion for review, moving the case to the Court of Federal
Claims (part B below). After judgment against them, the Sanchezes appealed to
the Federal Circuit (part C below). The Federal Circuit vacated the judgment and
remanded the case back to the Office of Special Masters (part D below).

A. Office of Special Masters

Trystan’s parents alleged that before Trystan received his six-months
vaccinations, he was developing normally. When he received his vaccinations, he
changed. By the time of the petition, Trystan had become developmentally
delayed. Pet., filed Oct. 17, 2011, at 11.

Shortly after filing the petition, the Sanchezes submitted evidence to support
their claim. The evidence can be divided into three types. Some evidence was in
the form of medical records from doctors who treated Trystan. E.g., exhibits 1, 8-
12. Other evidence was in the form of affidavits from Trystan’s family members,
including his mother and father. Exhibits 3-7. Finally, the Sanchezes presented a

3
report from Lawrence Steinman, a pediatric neurologist, who has presented
multiple reports and testified on the Sanchezes’ behalf throughout this case.
Exhibit 2.

As discussed below, the evidence showed that Trystan was taken to his six-
month well-baby checkup with Dr. Philip Brown on February 5, 2009. Exhibit 1 at
44. During this visit, Trystan received the allegedly causal vaccinations.

The medical records also show that on the morning of February 17, 2009,
Trystan returned to the pediatrician for an urgent care visit during which he was
examined and treated by Physician Assistant Jonathan P. Luna. Mr. Luna
diagnosed Trystan with a “[c]ommon cold” and “[v]iral syndrome.” Exhibit 1 at
48. Trystan’s temperature was 98.9 degrees and “fever” was noted. Id. at 49. Ms.
Sanchez told Mr. Luna that Trystan had been coughing and congested with fever.
Id. The records do not indicate that Ms. Sanchez told Mr. Luna anything about
Trystan exhibiting unusual arm movements or other signs of a neurological
condition. See id. at 48-49.

However, in their affidavits, Trystan’s family members recollected different
events. Most critically, Trystan’s father asserted that on the evening of February
16, 2009, Trystan displayed unusual movements:

Trystan was very hot with a fever of 103.2 and kept crying
inconsolably. . . . When I held Trystan in my arms and tried to
calm him down, I noticed a changed in Trystan. He felt very
stiff and uncomfortable. Originally, I thought he was throwing
some kind of fit and trying to show how miserable he felt by
stiffening his body. . . . I had never seen a child do that before.
Trystan began to hold his arm behind his back with a lot of
tension and jerk his head back. When I tried to comfort him
and gently put his arm back to the normal position, Trystan
would go right back to holding it behind his back again. This
lasted for only a few minutes. . . . (We later learned that this
was likely a seizure, but we had no idea at the time that it was
occurring.) We continued to rock Trystan to sleep and this
strange behavior slowly subsided.

Exhibit 4 (Germain Sanchez affidavit, signed Oct. 5, 2011) at 3, ¶ 6.

Mr. Sanchez’s assertion is critical because Dr. Steinman relied upon it in his
first report. Dr. Steinman acknowledged that when he wrote his first report
4
(September 28, 2011), doctors had not reached a diagnosis about Trystan. “The
diagnosis of Trystan Sanchez’[s] disorder has defied the best medical scientists at
three university medical schools as well as other treating physicians for now.”
Exhibit 2 at 2. Nevertheless, the lack of diagnosis did not prevent Dr. Steinman
from offering an opinion. “What we do know, however, is that Trystan Sanchez
was given multiple vaccines, he suffered from fever and he suffered from
seizures.” Id.

Dr. Steinman’s statement that “we do know . . . he suffered from seizures”
suggests a level of certainty that was inconsistent with an earlier portion of Dr.
Steinman’s report. In reviewing the events in Trystan’s history, Dr. Steinman
stated: “Eleven days later in the context of a febrile illness, he may have had a
seizure, manifest by stiffening and ‘holding his arm behind his back with a lot of
tension and jerked his head back.’” Id. at 1 (emphasis added).

Regardless, the remainder of Dr. Steinman’s report is premised upon Trystan
having a seizure. Dr. Steinman summarized his report as presenting an opinion
that “the vaccines due to their components, triggered seizures and that if not for
this vaccine induced seizure disorder, then Trystan Sanchez would not have
suffered such devastating neurological consequences.” Id. at 10. Over the next
four pages, Dr. Steinman presented theories of how the vaccines could cause
seizures. Id. at 10-14. Despite having Mr. Sanchez’s description of Trystan’s
unusual arm movements available to him, nowhere in Dr. Steinman’s first report
does he suggest that the behavior Mr. Sanchez described in his affidavit constituted
dystonia.2

The Secretary challenged the Sanchezes’ entitlement to compensation in his
report, filed pursuant to Vaccine Rule 4 on February 28, 2012. The Secretary
maintained that the Sanchezes “have not demonstrated the threshold facts upon
which the claim is based. Specifically, petitioners have not shown that Trystan
suffered from either seizures or developmental delays within an appropriate
temporal relationship to the February 5, 2009 vaccines.” Resp’t’s Rep. at 11. The
Secretary commented that no medical record created around February 2009
corroborates assertions made in the affidavits from the Sanchez family. Id. at 12.
With his report, the Secretary filed a report from Gerald Raymond, a specialist in

2
Dystonia is “dyskinetic movements due to disordered tonicity of muscle.” Dorland’s
Illustrated Medical Dictionary 576 (32d ed. 2012).

5
genetics and neurology, who has written many reports and testified for the
Secretary during this case. Exhibit A.

Because the parties and their experts disputed whether Trystan displayed
unusual arm movements starting in February 2009, the undersigned received oral
testimony from the five family members on May 15, 2012, in San Diego,
California.3 After the hearing, a status conference was held on May 29, 2012.

In the status conference, the undersigned discussed how the parties could
assist in resolving factual disputes. The process for bringing forward disputed
factual issues had at least three steps. The Sanchezes were instructed to propose a
series of facts, citing evidence supporting their assertion of facts. The Sanchezes
were directed to transmit their proposal to the Secretary and not to file their
proposed submission. The Secretary was instructed to respond to each proposed
finding of fact, either agreeing or disagreeing. If the Secretary disputed the
proposed assertion, the Secretary was to cite evidence supporting his position. The
Secretary was also not expected to file his response. Once the Sanchezes received
this document, they could comment. This back-and-forth was expected to continue
until the parties presented all their points. Then, and only then, the parties were
expected to submit a final version incorporating, in one document, all the
arguments regarding any factual disputes. After the parties had engaged in this
process for about four months, another status conference was held on October 11,
2012. The parties reported that they were close to finishing this process. Order,
issued Oct. 12, 2012.

The parties submitted a document titled “Joint Statement of Uncontroverted
Facts” on November 8, 2012. As noted by the Court of Federal Claims, see
Sanchez v. Sec’y of Health & Human Servs., 142 Fed. Cl. 247, 252-53 (2019),
vacated and remanded, 809 F. App’x 843 (Fed. Cir. 2020) (hereinafter “Opinion
and Order”), the description of the facts as “uncontroverted” reflects an imprecise
word choice to which the undersigned contributed. The undersigned had intended
to set forth a process by which the parties would identify the material facts that the
parties genuinely disputed. The undersigned did not expect that the parties would
produce a stipulation about all facts because, after all, the parties’ dispute about the

3
In considering the issues on remand, the undersigned has re-read the transcript from the
2012 hearing as well as notes, which record demeanor-based observations.

6
events in Trystan’s life necessitated the May 15, 2012 hearing. Instead, the parties
would identify the issues requiring resolution.

To some degree, the parties’ Joint Statement was not as helpful as
anticipated, and the undersigned recognizes that the instructions could have been
more detailed. In the absence of more direct guidance, the parties produced
statements such as “According to Jennifer [Ms. Sanchez], between her birthday and
the next time she took him [Trystan] to the doctor nearly two months later in late
April, Trystan lost control of his head.” Joint Statement ¶ 17 (citing Transcript
(“Tr.”) at 78) (emphasis added).4 The parties could easily agree that transcript
page 78 supports the proposition that Ms. Sanchez testified that Trystan lost control
of his head between February and April. However, the words that Ms. Sanchez
spoke during the hearing are not directly material. The more critical question---
and the one about which the parties disagreed---was whether, in fact, Trystan lost
control of his head between February and April. On this specific point, the
undersigned declined to credit Ms. Sanchez’s testimony because the records from a
pediatrician who saw Trystan at the end of April recorded “no neurological
symptoms.” See Ruling Finding Facts, issued Apr. 10, 2013, ¶¶ 13-14 (citing
exhibit 1 at 50-52).

In the Ruling Finding Facts, the undersigned also found that Trystan did not
exhibit arm contortions around February 16-17, 2009. Id. ¶¶ 8-11. The
undersigned reasoned that if Trystan had moved his arm unusually, then the
Sanchezes would have informed the physician’s assistant who saw Trystan on
February 17, 2009, and the physician’s assistant would have memorialized a
complaint in the notes.

On the other hand, the Ruling Finding Facts did credit the witnesses’
testimony that on the night following the February 5, 2009 vaccination, Trystan
cried inconsolably. He also had a lump on his left thigh and a fever. The fever
ebbed and flowed over the next few days. Ruling Finding Facts ¶ 7.

The Ruling Finding Facts directed the parties to provide it to their experts.
If the experts assumed facts that were not consistent with the Ruling Finding Facts,

4
The transcript page numbering runs consecutively across the three hearings in this case
but does contain some gaps in the numbering: fact hearing (pages 1-231), entitlement hearing
(pages 233-1011), and remand hearing (pages 2000-2179).

7
then the expert was unlikely to be persuasive. Id. at 16 (citing Burns v. Sec’y of
Health & Human Servs., 3 F.3d 415, 417 (1993)).

The Sanchezes filed another report from Dr. Steinman on May 22, 2013.
Exhibit 17. However, Dr. Steinman’s report seemed to resemble very closely his
previous report. For example, Dr. Steinman continued to assert that Trystan had
seizures. This prompted an order directing Dr. Steinman to explain the basis for
his opinion that Trystan had seizures. Order, issued June 14, 2013.

Dr. Steinman’s report did not really answer this question. He stated that
Trystan suffered seizures. Exhibit 28 at 2. He also stated that Trystan suffered one
continuous process. Id. at 3. In a December 6, 2013 status conference, the
Secretary questioned how Dr. Steinman linked an apparently isolated seizure with
developmental delay. Thus, the Sanchezes were ordered to file a status report.

The Sanchezes asserted that Trystan had “a process of continuous and/or
intermittent seizure activities commencing in February 2009.” Pet’rs’ Status Rep.,
filed Dec. 18, 2013, at 4. As evidence of these seizures, the Sanchezes pointed to
(1) the inconsolable crying on February 5, 2009; (2) the loud pitched cry and
kicking feet on February 16, 2009; (3) the inconsolable crying during March 2009,
when his parents watched a boxing match; (4) Trystan’s loss of skills by June 1,
2009; (5) inconsolable crying during the August 8, 2009 baby shower; (6) the
observation by Ms. Marin-Tucker on August 17, 2009, that Trystan’s extremities
seemed soft yet rigid; and (7) the development of tremors or twitching between
October 7, 2009, and November 12, 2009. Id. at 2. The Sanchezes also pointed to
the September 17, 2010 EEG that indicated, to the Sanchezes, partial seizures. Id.
at 3 (citing exhibit 1 at 181-82).

The Sanchezes additionally relied upon an August 2, 2010 note from Dr.
Friedman. There, Dr. Friedman recorded a history in which Trystan had “one
particularly bad night” during which “he would stiffen his arms behind his back, he
would jerk his arms and neck . . . Would do this minutes at a time. Dad would try
to straighten his arms but they would snap back. . . . After that night, this would
come and go.” Id. at 2-3 (quoting exhibit 1 at 194). The Sanchezes justified
reliance on Dr. Friedman’s August 2, 2010 record because the Ruling Finding
Facts stated that the parties agreed that records created after the November 12,
2009 visit with Dr. Michelson were accurate.

The parties discussed this status report about Trystan’s seizures in status
conferences held on January 17 and 28, 2014. The Secretary argued that the
Sanchezes’ reliance on the history recorded in Dr. Friedman’s note was “logical
8
insanity” in that it was not consistent with the Ruling Finding Facts. The Secretary
argued that the Sanchezes’ approach would allow them to go to a doctor “today”
and set forth a history about Trystan’s health in 2009.

A January 31, 2014 order attempted to resolve this dispute by distinguishing
between histories and findings in the reports from doctors. The undersigned stated
that:

paragraph 24 of the Findings of Fact was intended to state that
the medical records created after Trystan’s visit with Dr.
Michelson were accurate to the extent that the medical records
described Trystan’s contemporaneous condition. The
Sanchez[es’] account of remote events in Trystan’s life to Dr.
Friedman does not qualify as a contemporaneous record.

Order, issued Jan. 31, 2014. Accordingly, the parties were directed to confirm that
their experts were not relying upon Dr. Friedman’s record for the basis of events in
Trystan’s life between February 2009 through November 2009.

The Secretary responded to Dr. Steinman’s reports by presenting another
report from Dr. Raymond. 5 Dr. Raymond suggested that Trystan might benefit
from genetic testing because Trystan might have a mutation in his mitochondria.
Exhibit E at 2. Dr. Raymond wondered how Dr. Steinman could say that the
vaccinations caused Trystan’s problems when the doctors have been unable to say
what Trystan’s diagnosis is. Id. The Secretary also presented a report from
Edward Cetaruk, a medical toxicologist, who made the same point. Exhibit G at
17. Based, in part, on the criticisms from the Secretary’s experts, the undersigned
began to question whether a reasonable basis supported the claims set forth in the
petition. Order, issued May 13, 2014.

The Sanchezes produced another report from Dr. Steinman. Exhibit 36. In
response to Dr. Raymond’s suggestion that Trystan might have a genetic mutation

5
Although this decision does not mention each report from every expert, the undersigned
has reviewed and considered all reports submitted into evidence. See Moriarty v. Sec’y of
Health & Human Servs., 844 F.3d 1322, 1330 (Fed. Cir. 2016) (noting that the Vaccine Act
requires a special master to consider all relevant medical and scientific evidence of record).

9
affecting his mitochondria, Dr. Steinman offered a hypothetical opinion that
largely has become the Sanchezes’ claim:

[If Trystan had a genetic mutation,] one should remember that
there had been no issues related to this mutation prior to the
vaccines. Consequently, just in parallel with analysis of what
triggers clinical deficits in mitochondrial disorders, it can be
argued that this mutation was significantly aggravated by the
vaccines, which then progressed to a clinical picture with the
subsequent issues. We know that in many metabolic disorders
a stress like vaccination or in the case of organic acidemias a
protein load, will trigger neurologic deficits.

Exhibit 36 at 2. Dr. Steinman repeated this point later in his report, stating that as
an expert, he felt compelled to reexamine the evidence. Based upon the evidence,
Dr. Steinman wrote that “there is a plausible line of reasoning that Trystan Sanchez
had a mitochondrial disorder that was not expressed prior to his vaccinations; and,
his vaccinations significantly aggravated this disorder.” Id. at 11.

In developing this account, Dr. Steinman again presented a chronology of
events in Trystan’s life. In doing so, Dr. Steinman cited an August 7, 2012 report
from Dr. Haas. Dr. Haas recounted that Trystan had “acute onset regression and
dystonia at six months of age, following vaccination, which repeated with the next
set of vaccines at 12 months.” Id. at 13 (quoting exhibit 26 at 3). As will be
discussed later, Trystan’s dystonia (or lack thereof) is a prominent issue on
remand.

Three months before the start of a hearing previously scheduled for
September 10-12, 2014, the Sanchezes requested a continuance for the hearing so
that Trystan could have the whole exome sequencing performed as Dr. Haas
recommended. Pet’rs’ Status Rep., filed June 23, 2014. The Sanchezes hoped that
the sequencing would provide clarity as to Trystan’s illness. Id. Based on the
Sanchezes’ request, the hearing dates were postponed to May 2015. Order, issued
July 8, 2014. The Sanchezes were ordered to file the results of the genetic testing
as soon as they became available. Order, issued July 21, 2014.

The Sanchezes submitted the results from the first set of testing as exhibit 53
and a report from Dr. Haas about those results as exhibit 54. The genetic testing
showed that Trystan had a heterozygous mutation in the SDHA gene, the
c.667delG mutation. Exhibit 53 at 1-2. Dr. Steinman explained:

10
As the test results indicate, developmental regression,
hypotonia, spasticity, dystonia, seizures, high T2 W signal,
basal ganglia abnormalities and periventricular white matter
changes could be associated with an SDHA-related disorder. I
would add IF he were homozygous, he could have a
mitochondrial disease known as Leigh syndrome. However,
currently, the test results do not show that Trystan is
homozygous.

Exhibit 55 at 1. Dr. Steinman noted that Dr. Haas requested additional genetic
testing. Dr. Steinman added, “as indicated in my last supplemental expert report, if
the additional blood testing supports mitochondrial issues such as Leigh’s
syndrome or if Dr. Haas determines that there is a mitochondrial disorder based
upon the clinical findings, my last supplemental opinion, dated May 24, 2014,
addressed such occurrence.” Id.

The Sanchezes filed testing identifying Trystan’s genetic mutations on
January 23, 2015. Exhibit 59. In the ensuing status conference, the Secretary
emphasized that the genetic testing further undermined the reasonable basis for
continuing the case. However, the Sanchezes wanted to press forward. The parties
noted that they needed additional expert reports, although they also decided to
retain the May 2015 hearing date at that time. Order, issued Feb. 4, 2015. On
February 20, 2015, the Sanchezes filed a status report requesting that the May 2015
hearing be postponed. The Secretary did not object to this request. Order, issued
Mar. 3, 2015. Accordingly, the undersigned cancelled the May 2015 hearing and
scheduled a status conference for late April 2015 to discuss the next steps. Id.

During the April 2015 status conference, the undersigned stated a concern
that the newly-filed information regarding Trystan’s genetic mutations undermined
the Sanchezes’ claim of a vaccine injury because Trystan’s clinical course may be
consistent with what is expected based on the mutations alone. Order, issued May
8, 2015, at 1. The parties also discussed how the burden of proof is allocated in
genetics cases with the Sanchezes asking whether they as petitioners have the
burden to show how Trystan would have been but for the vaccination. The
undersigned encouraged the Sanchezes to develop evidence that would show that
Trystan was worse than would be otherwise expected for someone with his genetic

11
mutations. Id.6 Accordingly, the Sanchezes requested additional time to procure
genetic testing from Trystan’s siblings since the results might shed light on how
Trystan’s disease course may be different than what can be expected for someone
with his same genetic mutations. Id. The Sanchezes’ request was granted, and a
status conference was set for June 2015, to discuss the results from the new genetic
testing and the Sanchezes’ next steps. Id. at 1-2.

The Sanchezes stated that the additional genetic testing would not be
complete before the end of July 2015, and that the Sanchezes currently had an
appointment scheduled with their treating physician for late August 2015, to
discuss the results of this additional genetic testing. Pet’rs’ Status Rep, filed June
23, 2015. The undersigned set a status conference for the end of September 2015.
Order, issued June 24, 2015.

During the September 2015 status conference, the Sanchezes contended that
the Federal Circuit’s opinion in Paluck v. Sec’y of Health & Human Servs., 786
F.3d 1373 (Fed. Cir. 2015), helped to support the reasonable basis for their claim
because, in that case, the Federal Circuit concluded that a vaccination can
aggravate a mitochondrial disorder. In addition, the parties discussed the need for
additional expert reports in light of the new information regarding Trystan’s
genetic mutations. Order, issued Oct. 1, 2015.

Over the course of the next year, both the Sanchezes and the Secretary filed
additional reports from their respective experts. The Sanchezes added a new
expert with a specialty in mitochondrial disorders, Dmitriy Niyazov, whose first
report is exhibit 68. Dr. Niyazov opined that Trystan “experienced developmental
regression, caused by a vaccine reaction, which exacerbated his deficient cellular
energy metabolism due to his SDHA gene mutations.” Exhibit 68 at 7. For the
initial manifestation of Trystan’s Leigh’s disease,7 Dr. Niyazov identified the

6
In April 2015, it appeared that the burden of showing how the vaccinee would have
developed “but for” the vaccination fell to petitioners. See Locane v. Sec’y of Health & Human
Servs., 685 F.3d 1375, 1379 (Fed. Cir. 2012).
However, after the Federal Circuit remanded this case, the Federal Circuit declared that
the petitioners do not bear the burden of proof on this point for cases involving genetic disorders.
Sharpe v. Sec’y of Health & Human Servs., 964 F.3d 1072, 1084-85 (Fed. Cir. 2020).
7
Dr. Haas confirmed Trystan’s diagnosis of Leigh’s disease. See exhibit 62 at 5.

12
“inconsolable crying along with the fever” that occurred within 48 hours of the
February 5, 2009 vaccination. Id. at 8. He continued:

This inflammatory response served as the initial catabolic event
in Trystan that triggered a gradual process of developmental
regression and aggravation leading to [Leigh’s syndrome] over
the next several months which has become more evident around
June 1, 2009 (inconsolable crying, hypotonia, arm contortion,
etc.). However developmental regression was slowly
developing ever since the crying and fever took place as the
result of the vaccination . . . .

Id.

Dr. Niyazov also addressed whether the genetic mutations could inform an
assessment of how Trystan would have developed but for the vaccinations. He
opined that due to “variable expressivity” and “incomplete penetrance,” Trystan
may not have developed Leigh’s syndrome at all. Id. at 10. Dr. Niyazov heavily
relied upon the Levitas article to support his opinion. Id.; see Aviva Levitas et al.,
Familial neonatal isolated cardiomyopathy caused by a mutation in the
flavoprotein subunit of succinate dehydrogenase, 18 Eur. J. Hum. Genetics 1160
(2010), filed as exhibit 79.

Dr. Steinman’s report roughly presented the same view as taken by Dr.
Niyazov in his report. Dr. Steinman’s conclusion was “if not for the vaccinations
on Feb. 5, 2009, Trystan Sanchez would not be suffering from Leigh’s disease.”
Exhibit 95 at 1. Much of Dr. Steinman’s December 10, 2015 report repeats
information presented in his previous reports, reflecting Dr. Steinman’s intention
to present a comprehensive report. For example, Dr. Steinman referenced his
September 13, 2013 report (exhibit 28) in which he stated Trystan began to have
seizures on February 16, 2009, when he was running a fever, having difficulty
breathing, crying with a loud-pitched cry, jerking around, and startling awake. Id.
at 28 (citing Ruling Finding Facts ¶ 8). Like his earlier report, Dr. Steinman again
stated that Dr. Haas’s August 7, 2012 report provided detail about Trystan’s
condition on February 16, 2009. Dr. Steinman reproduced the report in which Dr.
Haas stated, in part, “11 days after the vaccination, [Trystan] had an episode of
‘contortion’ in the upper limbs.” Id. at 39 (reproducing exhibit 26 at 1). Similarly,
Dr. Steinman cited a report from Dr. Haas that describes Trystan as having “acute
regression associated with significant dystonia at 6 months of age following
vaccination. He subsequently had a second episode of developmental regression

13
12 months later.” Id. at 16 (citing exhibit 54 at 1-2).8 Although Dr. Steinman
recognized that Dr. Haas described Trystan as having dystonia following his six-
month vaccinations; that Dr. Friedman noted Trystan had dystonia on August 2,
2010 (exhibit 95 at 11, relying upon exhibit 1 at 198); and that Trystan’s genetic
mutations are associated with dystonia (exhibit 95 at 14, relying upon exhibit 53 at
1-4), Dr. Steinman did not suggest that Trystan suffered dystonia on February 16,
2009.

In response to these two reports and to address the genetic testing, the
Secretary obtained a report from Dr. Raymond. Dr. Raymond concluded that
Trystan is “a child with Leigh syndrome secondary to mutations in the gene
SDHA. This is the sole cause of his neurologic condition and the onset was not
caused by immunizations received and his disease course is consistent with the
condition and was not aggravated by the receipt of vaccination.” Exhibit H at 8.
The primary basis for Dr. Raymond’s opinion was that Trystan’s case matched a
case reported by Parfait in that both Trystan and the Parfait subject had a
compound heterozygous mutation. Id. at 3.

The parties then obtained additional reports from the experts. Essentially,
these reports reinforced the themes from the previous reports. Dr. Niyazov
asserted that mutations can present differently, benignly or pathogenically, and
relied upon Levitas. See exhibit 102. In contrast, Dr. Raymond relied upon Parfait
as a report involving a child very similar to Trystan and the reports that companies
that produce genetic reports characterize Trystan’s mutations as pathogenic. See
exhibit P.

After the parties finished the submission of expert reports, they filed briefs.
The Sanchezes filed their brief on July 7, 2017. The Secretary responded on
September 1, 2017.

In the pre-hearing status conference, the undersigned defined the amount of
time the parties had to elicit testimony from their own witnesses on direct
examination, or from the other party’s witness on cross-examination. See order,
issued Nov. 27, 2017, at 3.

8
While Dr. Steinman accurately cites Dr. Haas’s November 11, 2014 report as saying
that Trystan had dystonia at 6 months of age (exhibit 54 at 1-2), Dr. Haas has carried this history
forward from his first report. See exhibit 26 at 3.

14
A four-day hearing was held on December 4-7, 2017. During the hearing,
the Sanchezes solicited testimony from their two expert witnesses: Dr. Steinman
and Dr. Niyazov. The Secretary solicited testimony from four expert witnesses:
Dr. Raymond, Dr. Stephen McGeady, Dr. Cetaruk, and Professor Dean Jones. The
hearing ended half a day early, with both parties and the undersigned not using all
their allotted time. Among other issues, the evidence concerning Trystan’s arm
contortions and possible dystonia were discussed at the hearing. Specifically, Dr.
Steinman characterized Trystan’s “arm contortions” occurring after the vaccination
when he was six-months old as dystonia. Tr. 357 (“dystonic posturing of his
arm”). He further discussed what he believes was Trystan’s dystonia as being part
of the typical progression of Leigh’s syndrome. Tr. 354. On this basis, Dr.
Steinman concluded that the presence of dystonia during this time “added weight”
to evidence showing that the vaccination was a causal “environmental trigger” of
Trystan’s development of Leigh’s syndrome. Tr. 358. Furthermore, he viewed
what he characterized as the dystonic posturing of Trystan’s arm as an indicator of
a seizure occurring at this time. Tr. 357.

The undersigned found that the Sanchezes were not entitled to compensation
in a decision issued on October 9, 2018. The decision began with a statement of
facts from Trystan’s life. In doing so, the decision attempted to summarize the
April 10, 2013 Ruling Finding Facts. For example, the decision explained that the
undersigned had found notations in medical records created contemporaneously
more persuasive than testimony provided later.

However, in a critical aspect, the October 9, 2018 decision deviated from the
April 10, 2013 Ruling Finding Facts. The Ruling Finding Facts stated that around
February 17, 2009, “Trystan did not begin to exhibit arm contortions.” Ruling
Finding Facts ¶ 11. However, the October 9, 2018 decision stated that around
February 15, 2009, Trystan’s “arms contorted and he was jerking around.
However, these movements were of the type typically displayed by an infant
suffering from a cold.” Sanchez v. Sec’y of Health & Human Servs., No. 11-
685V, 2018 WL 5856556, at *4 (Fed. Cl. Spec. Mstr. 2018), mot. for rev. denied,
142 Fed. Cl. 247, 252-53 (2019), vacated and remanded, 809 F. App’x 843 (Fed.
Cir. 2020) (hereinafter “Decision”). The October 9, 2018 decision did not explain
this inconsistency.

The October 9, 2018 decision also modified the April 10, 2013 Ruling
Finding Facts in one other way, although this change is less important. The April
10, 2013 Ruling stated that Trystan began to lose milestones between May 17,
2009, to June 17, 2009, and specified the mid-point of this range (June 1, 2009).
15
Ruling Finding Facts ¶¶ 18, 20. However, in the December 2017 hearing, the
Sanchezes brought forward evidence suggesting that parents might not
immediately detect the loss of a child’s milestones. Tr. 438-39. Therefore, the
October 9, 2018 adjusted the loss of milestones to “the beginning of May 2009, at
the earliest.” Decision at 8, 2018 WL 5856556, at *4.

After completing a statement of facts about Trystan’s life, the decision set
out the procedural history, the standards for adjudication, and an overview about
genetics (Sections II-IV). The Analysis section (section V) was divided into three
parts. In part A, the undersigned found that the Sanchezes showed that a
vaccination could aggravate an underlying mitochondrial disorder. In part B, the
undersigned found that the Sanchezes did not establish that the vaccinations
affected Trystan’s mitochondrial disorder for two reasons. First, the manifestation
of neurologic delay, which was no earlier than May 1, 2009, occurred too long
after the February 5, 2009 vaccination. Second, during the interim, Trystan
experienced infections that could have caused his metabolic decompensation. In
part C, the undersigned reviewed the genetic evidence, the arguments from Dr.
Niyazov about Levitas, and the arguments from Dr. Raymond about Parfait. The
conclusion was that “the Secretary provided persuasive evidence to show that
Trystan’s mutations were expected to cause serious mitochondrial disease . . . [and]
that Trystan’s actual course is entirely consistent with what is known about his
genetic mutations.” Decision at 40-41, 2018 WL 5856556, at *25.

B. Court of Federal Claims

The Sanchezes disagreed with the decision by filing a motion for review on
November 8, 2018. In their motion for review, the Sanchezes argued that the
undersigned committed reversible error for three reasons. First, the Sanchezes
argued that the undersigned failed to draw reasonable inferences regarding the
timing of Trystan’s symptoms, and erroneously did not credit the Sanchezes’ oral
testimony or reports to various medical providers regarding changes in Trystan’s
condition following vaccination. The Sanchezes also highlighted the
undersigned’s acknowledgement of Trystan’s arm contortions in February 2009
following the vaccination and argued that the conclusion that these were consistent
with a cold (and not necessarily neurological decline) was also in error. Second,
the Sanchezes argued that the undersigned disregarded the Federal Circuit’s
findings in Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373 (Fed. Cir.
2015), or alternatively disregarded evidence regarding the acceptable timing for the
onset of neurodegeneration. Finally, the Sanchezes argued that the undersigned
erroneously disregarded evidence of challenge-rechallenge.
16
In a response filed on December 7, 2018, the Secretary first argued that the
undersigned’s findings regarding the onset of loss of skills were supported by
reasonable inferences because: (1) deeming the earlier, rather than later, medical
records as comparatively more persuasive was not arbitrary or capricious; (2) the
undersigned’s determination that Trystan’s February 2009 symptoms were
consistent with a cold was supported by the record; and (3) the 2009 calendar
entries used by petitioners to support their claim are unreliable. Second, the
Secretary argued that the undersigned properly found that Trystan’s
neurodegeneration did not occur within a medically acceptable time frame
sufficient to infer causation. The Secretary argues this primarily because Trystan’s
first clear sign of neurodegeneration (loss of skills) occurred months after
vaccination, and the assertion that other earlier behavior, such as inconsolable
crying, indicate neurodegeneration that ebbed and flowed following the
vaccination was merely speculative. Finally, the Secretary argued that petitioners’
reliance on Paluck is misplaced because, unlike in that case, the undersigned did
not set a “hard and fast” time constraint for the onset of neurodegeneration and
instead properly weighed evidence regarding the timing of Trystan’s indicator of
neurodegeneration (skill loss) and whether this supported an inference of
causation.

Judge Campbell-Smith issued an opinion denying the motion for review on
February 11, 2019. In so doing, the Court found that the undersigned did not err in
giving little weight to or emphasis on the day planner evidence, given that
petitioners did not provide arguments as to the relevance of this evidence, and that
the differences in recitations of facts that petitioners argued against were the result
of the undersigned giving greater weight to contemporaneous medical records than
petitioners’ testimony.

With respect to the causation analysis, the Court identified five key issues
raised by petitioners: (1) challenge-rechallenge; (2) findings regarding onset of
neurodegeneration; (3) effect of the Paluck II decision; (4) evidence of colds and
infections and petitioners’ failure to address the alternate cause issue; and (5) the
undersigned’s consideration of evidence of arm contortions. First, the Court found
that though the challenge-rechallenge issue was not mentioned in the
undersigned’s decision, he need not address all of petitioners’ arguments and he
had already found that the relevant symptoms had not occurred, making the
challenge-rechallenge argument moot. Second, the finding regarding onset of
neurodegeneration was not arbitrary or capricious. Third, the evidentiary record in
this case was substantially different than that of Paluck II; thus, Paluck II did not
dictate a finding of entitlement in this case. Additionally, the undersigned did not
17
use the temporal measure rejected in Paluck II and did not err in his evaluation of
the expert testimony under Paluck II. Fourth, the undersigned did not err in
finding that petitioners’ arguments regarding colds and infections as an alternate
cause were inadequate. Fifth and finally, though the undersigned changed his
finding between the Ruling Finding Facts and entitlement decision regarding the
occurrence of arm contortions, he maintained that these arm contortions did not
indicate of a neurological condition or cause. Thus, the motion for review was
denied and judgment entered.

C. Federal Circuit

The Sanchezes filed their notice of appeal to the Federal Circuit on April 9,
2019. In their appellate brief, filed on May 24, 2019, the Sanchezes argued: (1)
that the undersigned failed to consider the totality of the record, including Dr.
Niyazov’s expert testimony, regarding the onset of neurodegeneration adequately,
and that Judge Campbell-Smith failed to examine all the evidence in determining
whether the undersigned committed legal error on this point; (2) that the
undersigned erroneously failed to address evidence of challenge-rechallenge; and
(3) that Paluck dictated a finding of entitlement in this case.

In response, the Secretary argued first, that petitioners’ arguments amounted
to asking the Federal Circuit to reweigh evidence and that the undersigned
correctly found (1) that petitioners did not establish by preponderant evidence that
three months was a medically acceptable time frame for onset, and (2) the
undersigned’s conclusion that Trystan’s first manifestation of Leigh’s syndrome
was his loss of skills three months post-vaccination was reasonable. Second, the
Secretary argued that there was no evidence of challenge-rechallenge in this case.
Finally, the Secretary argued that the evidentiary record in this case is substantially
different from Paluck, making petitioners’ reliance on that case misplaced.

After holding oral arguments, the Federal Circuit issued its opinion on April
7, 2020, remanding the case for reconsideration on multiple issues. As a
preliminary issue, the Federal Circuit ruled that the differences between the
evidentiary records of this case and Paluck are substantial enough “such that the
outcome of this case is not dictated by Paluck.” Sanchez v. Sec’y of Health &
Human Servs., 809 F. App’x 843, 852 (Fed. Cir. 2020). Thus, on that question, the
Federal Circuit rejected the Sanchezes’ arguments.

However, for other issues, the Federal Circuit was more receptive to the
Sanchezes’ contentions. The Federal Circuit first identified a “significant”
discrepancy between the undersigned’s Ruling Finding Facts and recitation of facts
18
in Decision regarding the presence of arm contortions in February 2009. Id. at
852-53. Specifically, the Court stated:

Importantly, because of the change in the findings made with
respect to the arm contortions, the special master’s finding that
Trystan’s behavior on the night of February 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 consideration of the causation issue in
light of the special master’s findings in 2018 regarding
Trystan’s arm contortions.

Id. at 853.

Second, the Federal Circuit directed the undersigned to revisit his analysis of
Althen prongs 2 and 3, specifically “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 injuries” and
“whether Trystan’s infections between February and May of 2009 caused the
manifestation of his Leigh’s syndrome, independent of his vaccinations.” Id. The
Federal Circuit noted that the undersigned “treated [Althen prongs 2 and 3]
together as being directed to the single issue of causation,” but specified that the
undersigned should make explicit findings with respect to each of these
considerations separately on remand. Id. In the event that the undersigned finds
that the Sanchezes have made out a prima facie case, he should then address
whether Trystan’s post-vaccination infections triggered the manifestation of his
Leigh’s syndrome, independent of the vaccinations. Id. at 853-54.

Third, the Federal Circuit found that the undersigned had not “implicitly
rejected” the challenge-rechallenge argument in his decision and that “the special
master should address that theory expressly on remand.” Id. at 854. The Federal
Circuit specified that the factual findings upon which the entitlement decision was
based pre-dated expert testimony, much of which asserted challenge-rechallenge.
Additionally, the Federal Circuit noted that the two medical reports from Ms.
Marin-Tucker, upon which the undersigned relied in coming to his factual
conclusion that Trystan did not suffer additional loss of skills following his August
2009 vaccinations, may suggest slight differences or increases with respect to loss
of skills. Id.; see Ruling Finding Facts at 15 n.11 (finding against additional
neurological symptoms following Trystan’s August 2009 vaccinations based on

19
Ms. Marin-Tucker’s reports of the Sanchezes denying “any new complaints” but
reporting “no improvement either” at Trystan’s October 2009 appointment) (citing
exhibit 1 at 57). The Federal Circuit directed the undersigned to explicitly address
challenge-rechallenge in light of these medical reports. Id.

Finally, the Federal Circuit invited further consideration of medical evidence
or literature relevant to whether, because of Trystan’s genetic mutations, “the
timing and severity of his Leigh’s syndrome would have been the same, regardless
of the effect of the vaccinations.” Id. The Federal Circuit noted that this issue was
left open at the end of the entitlement decision and that, given how much time has
passed since the decision was issued and the ever-evolving nature of genetics
research, the undersigned may wish to consider additional evidence related to this
aspect of the case. Id.

D. Office of Special Masters on Remand

When the case returned to the Office of Special Masters, the parties through
their attorneys and expert witnesses worked quickly. After the mandate from the
Federal Circuit issued, the undersigned proposed a schedule that allowed for the
submission of supplemental reports in advance of a hearing. Orders, issued June 3,
2020 and June 12, 2020. As part of this proposed schedule, the undersigned also
ordered the Sanchezes to file a status report answering certain questions regarding
updates on Trystan’s status, including updated medical records and Trystan’s
Individualized Education Plan, and indicating whether they anticipated filing
supplemental expert reports. Order, issued June 3, 2020. The undersigned ordered
the Secretary to submit a status report indicating whether he anticipated filing a
supplemental expert report. Id. The Sanchezes and the Secretary filed their status
reports on June 8, 2020, and June 10, 2020, respectively. They both indicated an
intention to file supplemental expert reports and agreed to the undersigned’s
proposed pre-hearing schedule. The Sanchezes also filed additional updated
medical records and Trystan’s Individualized Education Plan.

The Sanchezes submitted initial expert reports from Dr. Steinman (exhibit
185) and Dr. Niyazov (exhibit 189), and the Secretary submitted an initial expert
report from Dr. Raymond (exhibit P). They also submitted responsive reports.
Exhibits 195, 196, and Q.

A prehearing status conference was held on July 7, 2020, to discuss
proceedings for the hearing. In this status conference, the undersigned asked the
attorneys whether the undersigned might ask questions of the expert witnesses
first, followed by each party’s questioning. Both attorneys agreed to this process.
20
In hearings, special masters are permitted to be inquisitorial. See Doe v. Sec’y of
Health & Human Servs., 76 Fed. Cl. 328, 334 (2007) (commenting on the “active
role of the Special Master in questioning witnesses”); Hines v. Sec’y of Health &
Human Servs., 21 Cl. Ct. 634, 648 (1990), aff’d, 940 F.2d 1518 (Fed. Cir. 1991)
(“The Special Master is not required to be a ‘potted plant’ at the hearing . . .
Rather, the legislative history of the newly-amended Vaccine Act emphasizes that
‘[t]he system is intended to allow the proceedings to be conducted in an
“inquisitorial” format’. . . .” (quoting 135 Cong. Rec. H9476 (daily ed. Nov. 21,
1989))).

A hearing was held on July 9, 2020, during which the experts testified
remotely via videoconferencing. Though the undersigned set aside two days for
the hearing, the parties confirmed that they had no further questions for witnesses
at the conclusion of the first day, and the hearing ultimately only lasted for one
day.

After the hearing, on July 10, 2020, the undersigned issued an order for post-
hearing briefs, which outlined various procedural and substantive questions for the
parties to address. These questions were tailored to address the remand issues
presented by the Federal Circuit and specific items of relevance that arose as part
of the experts’ testimony at the hearing. On an expedited schedule, the parties
submitted two rounds of briefs simultaneously. The parties submitted their first
briefs on July 29, 2020, and they submitted their reply briefs on August 5, 2020.
Along with their initial post-hearing brief, the Sanchezes submitted additional
medical literature aimed at addressing certain points in the undersigned’s briefing
order. The Secretary did not object to this additional medical literature submitted
after the official closing of the evidentiary record. Resp’t’s Status Rep., filed July
31, 2020. With the parties’ briefs and reply briefs submitted, the case is again
ready for adjudication.

III. Qualifications of Experts

The adjudication begins with a review of the qualifications of the six people
whom the parties have advanced as experts. Because the Sanchezes advance the
backgrounds of their experts to support their claim (see, e.g., Pet’rs’ Remand Br. at
12) and because special masters may consider the background of a person offering
opinion testimony, the qualifications are set forth below. As part of the review, the
undersigned also has attempted to search for commentary about each person’s past
testimony even-handedly. See Greene v. Sec’y of Health & Human Servs., 146
Fed. Cl. 655 (2020) (noting that a failure to consider the (lack of) expertise for the

21
Secretary’s experts in the context of considering the (lack of) expertise for the
petitioner’s experts was arbitrary and capricious).

A. The Sanchezes’ Experts

Initially, the Sanchezes relied upon Dr. Steinman. After Trystan’s Leigh’s
syndrome was diagnosed, they added a second expert, Dr. Niyazov.

1. Lawrence Steinman

Dr. Steinman has often been retained by petitioners and special masters have
become accustomed to reviewing his opinions. Dr. Steinman graduated from the
medical school at Harvard University. He was a resident in pediatrics at Stanford
University Hospital in 1974. He had fellowships from 1975-77, including one at
the National Institutes of Health. In 1977-80, he was a resident in pediatric and
adult neurology at the Stanford University Hospital. Beginning in 1980, Dr.
Steinman served in various academic roles, primarily at Stanford University. From
2002 to 2011, he chaired the Stanford University program in immunology. From
2008 to the present, he was the incumbent of the George A. Zimmerman Chair as
professor of neurological sciences, neurology, and pediatrics. Exhibit 168 (Dr.
Steinman’s curriculum vitae). He became board-certified in neurology in 1984.

Dr. Steinman’s research has focused on multiple sclerosis. The National
Multiple Sclerosis Society and the American Academy of Neurology awarded him
the John M. Dystel prize for outstanding contributions in multiple sclerosis
research in 2004. Seven years later, the International Federation of Multiple
Sclerosis Societies awarded him the Charcot Prize for lifetime achievement in
multiple sclerosis research. Many of the more than 500 articles Dr. Steinman has
written or co-written concern how the immune system may cause demyelinating
diseases such as multiple sclerosis. See exhibit 168, passim.

While much of Dr. Steinman’s career has focused on multiple sclerosis, his
earlier work involved subjects much closer to the issues involved in the pending
case. Dr. Steinman researched the pertussis vaccine and obtained one or two
patents related to the pertussis vaccine. Tr. 244-25. Dr. Steinman also discovered
a mitochondrial disease. Tr. 247.

Other special masters have noted that, as Dr. Steinman’s research and
administrative responsibilities have increased, Dr. Steinman’s participation in
patient care has decreased. E.g., Rolshoven v. Sec’y of Health & Human Servs.,
No. 14-439V, 2018 WL 1124737, at *6 (Fed. Cl. Spec. Mstr. Jan. 11, 2018)
22
(indicating that Dr. Steinman sees 10-20 patients per month); Blackburn v. Sec’y
of Health & Human Servs., No. 10-410V, 2015 WL 425935, at *7 (Fed. Cl. Spec.
Mstr. Jan. 9, 2015) (stating that, due to a focus on research, Dr. Steinman has seen
“considerably fewer patients in the last five years than he saw earlier in his career”
and “[d]uring the last five years, has only seen patients approximately one month
out of the year”); see also Tr. 2055 (Dr. Steinman: “my different responsibilities
have varied with the decade and my other activities”).

In their briefing, the Sanchezes advance Dr. Steinman as an expert in
pediatrics. See Pet’rs’ Remand Br. at 12. While Dr. Steinman is the incumbent of
the George A. Zimmerman chair as a professor of neurological sciences,
neurology, and pediatrics, the depth of Dr. Steinman’s experience in pediatrics,
especially with infants, is not especially clear. For example, in the December 2017
hearing, the Sanchezes brought out direct testimony from Dr. Steinman about his
qualifications in neurology and immunology. The Sanchezes offered “Dr.
Steinman as an expert in neurology and immunology,” and he was recognized as
an expert in those two fields. Tr. 250. The Sanchezes did not develop any
information about Dr. Steinman’s background in pediatrics and the Sanchezes did
not offer Dr. Steinman as an expert in pediatrics. In the remand hearing, Dr.
Steinman stated that he has cared for approximately 100 infants in the last year and
sees about six mitochondrial cases per year. Tr. 2014-15. On redirect
examination, the Sanchezes elicited vague testimony about Dr. Steinman’s work in
pediatrics. See Tr. 2056.

With respect to Dr. Steinman’s opinions in the field of pediatrics, especially
for infants, the undersigned has less confidence in them. One reason is that Dr.
Steinman seems to have relatively less direct experience in caring for infants. For
example, Dr. Steinman never became board-certified in pediatrics. Tr. 2014.
When Dr. Steinman was asked about developmental milestones at various months,
he did not answer with much specificity and his demeanor suggested that he could
not answer this question spontaneously. Tr. 2016, 2052-54. Nevertheless, the
undersigned is not rejecting any of Dr. Steinman’s opinions wholesale. The
undersigned merely notes that Dr. Steinman appears to have relatively less
experience with infants than in other areas, such as multiple sclerosis.

Another reason for some skepticism about Dr. Steinman’s opinions is a
concern about the way Dr. Steinman has acted as an expert witness. Special
masters have indicated that Dr. Steinman presents opinions as an advocate for the
petitioners who retain him. See, e.g., D.G. v. Sec’y of Health & Human Servs.,
No. 11-577V, 2019 WL 2511769, at *182 (Fed. Cl. Spec. Mstr. May 24, 2019);
23
Chinea v. Sec’y of Health & Human Servs., No. 15-095V, 2019 WL 1873322, at
*19 (Fed. Cl. Spec. Mstr. Mar. 15, 2019), mot. for rev. denied, 144 Fed. Cl. 378
(2019); Mueller v. Sec’y of Health & Human Servs., No. 06-775V, 2011 WL
1467938, at *19 n.19 (Fed. Cl. Spec. Mstr. Mar. 16, 2011). This observation, too,
does not force an automatic rejection of everything that Dr. Steinman says.
However, the frequency with which special masters have commented on Dr.
Steinman’s performance as an expert witness prompts the undersigned to take Dr.
Steinman’s opinion with, perhaps, an extra grain of salt.

2. Dmitriy Niyazov

While special masters are quite familiar with Dr. Steinman, Dr. Niyazov is
new to the Vaccine Program. Tr. 374, 389-90 (describing previous experience in
one case or two cases with vaccines). Dr. Niyazov graduated with a distinction in
research from the school of medicine for the University of Rochester in 2001. In
the next two years, he had an internship and residency in surgery at Emory
University School of Medicine. But, he found he did not like that specialty and
changed to medical genetics, in which he was a resident from 2005 to 2007.
Exhibit 167 (Dr. Niyazov’s curriculum vitae); Tr. 374-75.

Beginning in January 2008, he has worked in New Orleans, Louisiana, for
the Ochsner Health System as the section head for medical genetics in the
department of pediatrics. Exhibit 167. He has also been an instructor for the
Tulane University School of Medicine. Id.

Dr. Niyazov focuses on treating mitochondrial disorders. He participates in
various organizations and panels about mitochondrial disorders. Tr. 376, 384-85.
In December 2017, Dr. Niyazov was treating approximately 16 cases with
confirmed Leigh’s syndrome and another 25 patients with suspected Leigh’s
syndrome. Id. 387. Some of these patients live in other countries and have seen
on-line presentations. Dr. Niyazov believes that exercise, nutrition, and vitamins
can help treat mitochondrial diseases, although the Food and Drug Administration
has not approved any of these treatments. Id. 388. Some of Dr. Niyazov’s
approximately three dozen publications concern mitochondrial disease. See
exhibit 167 at 2-6.

In the December 2017 hearing, the Sanchezes offered Dr. Niyazov as an
expert in the field of genetics, including mitochondrial disorders, and he was
accepted without objection. The Sanchezes did not offer Dr. Niyazov as an expert
in the field of pediatrics. Tr. 391.

24
In the hearing on remand, Dr. Niyazov acknowledged that he is not board-
certified in pediatrics. Id. 2064. However, in the last five years, Dr. Niyazov has
seen at least 1,000 infants, although not all those children suffered from
mitochondrial disease. While Dr. Niyazov works with developmental
pediatricians, he was generally familiar with developmental milestones during the
first year. Id.

Dr. Niyazov’s demeanor suggested that he expressed his opinions sincerely
in the sense that Dr. Niyazov honestly believed what he was saying. His opinions
regarding genetics, with some exceptions noted below, were grounded in peer-
reviewed articles.

When Dr. Niyazov strayed from the fields of genetics and mitochondrial
disorders, his opinions were shakier. For example, although Dr. Niyazov opined
about oxidative stress, Dr. Niyazov has relatively little experience in that field.
See id. 548-49.9

Dr. Niyazov has limited experience testifying in the context of the Vaccine
Program. However, in the few cases he has been a part of, other special masters
have indicated that while his testimony has been credible overall, it has suffered
from some inconsistencies. Specifically, one special master stated that he has
“waffled” somewhat in his testimony and that his “testimony about the reliability
of his records . . . was somewhat inconsistent.” Reddy v. Sec’y of Health &
Human Servs., No. 13-208V, 2015 WL 5578610, at *17, *20 (Fed. Cl. Spec. Mstr.
Aug. 26, 2015). Additionally, another special master mentioned some concern
with Dr. Niyazov over either not properly supporting contentions with relevant
research literature or overstating the significance of certain studies in coming to his
conclusions. See Reed v. Sec’y of Health & Human Servs., No. 08-650V, 2018
WL 6844458, at *66, *87 (Fed. Cl. Spec. Mstr. Dec. 4, 2018).

B. Secretary’s Experts

In the December 2017 hearing, the Secretary presented opinion testimony
from four people. On remand, the Secretary relies primarily on Dr. Raymond. To

9
Dr. Niyazov’s relative weakness in the field of oxidative stress (especially when
compared to the experience of Dean Jones) did not affect the outcome of the Sanchezes’ case.
The undersigned determined that the Sanchezes could meet their burden regarding Althen prong
1 without establishing the persuasiveness of the oxidative stress theory. Decision at 19-21, 2018
WL 5856556, at *11-12.

25
a lesser extent, the Secretary also relies upon Dr. McGeady. Thus, their
qualifications are reviewed more thoroughly. For the remaining two experts, Dr.
Cetaruk and Dean Jones, the review can be more summary because their opinions
do not meaningfully affect the issues on remand.

1. Gerald Raymond

Dr. Raymond graduated from the University of Connecticut School of
Medicine in 1984. He was first an intern and then a resident in pediatrics at Johns
Hopkins Hospital from 1984 to 1986. He then had another residency in neurology
and fellowship in developmental neuropathology. His final fellowship, which was
from 1990 to 1993, was in genetics and tetralogy at Massachusetts General
Hospital. Exhibit M (Dr. Raymond’s curriculum vitae).

From 1993 to 2012, Dr. Raymond worked as a pediatric neurologist for the
Kennedy Krieger Institute in Baltimore, Maryland. Through this time, he held
academic posts in neurology at the Johns Hopkins University School of Medicine,
culminating in a tenured position as a professor of neurology. Next, Dr. Raymond
became a professor in neurology with tenure at the University of Minnesota School
of Medicine for approximately five years. Then, starting in 2017, he became a
professor in pediatrics and neurology at the Penn State College of Medicine.
Exhibit M at 2; Tr. 779-80.

Dr. Raymond holds board certifications in clinical genetics and in neurology
with a special competence in pediatric neurology. According to Dr. Raymond,
approximately 12-20 people hold dual certifications in genetics and neurology.
From this group, Dr. Raymond mentored 6-10 people. Tr. 785.

In December 2017, Dr. Raymond was spending approximately 60 percent of
his time in clinical duties with the remainder of his time being research and
administration. Tr. 783. Dr. Raymond estimated that he sees approximately 18-20
patients per week. Tr. 781. His patients include children and adults. Tr. 782. In
his previous positions, Dr. Raymond saw six or seven cases of genetically
confirmed Leigh’s syndrome. He also saw other cases in which the disease was
suspected but not confirmed. Tr. 788. At the December 2017 hearing, Dr.
Raymond was no longer following these patients with Leigh’s syndrome. Tr. 787,
844.

Dr. Raymond focuses his research on adrenoleukodystrophies, which are
disorders of the brain’s white matter. Tr. 782, 842. Dr. Raymond has not

26
published any papers on Leigh’s syndrome or on mutations in the SDHA gene. Tr.
842.

Dr. Raymond held a board certification in pediatrics from 1991-2005.
Exhibit M at 16. He let that certification lapse. Tr. 845, 2114.

Dr. Raymond was offered as an expert in the field of neurogenetics and
pediatric neurology. He was accepted without objection. Tr. 789.

Like Dr. Niyazov, Dr. Raymond appeared to offer sincerely held opinions.
In the field of genetics, Dr. Raymond’s opinions consistently aligned with
publications that appeared in peer-reviewed journals. Dr. Raymond avoided
offering opinions in fields in which he is not qualified.

The consistency between Dr. Raymond’s opinions and the statements found
in peer-reviewed literature left the impression that Dr. Raymond was expressing
opinions about Trystan’s case as he believed them. Although on cross-
examination, Dr. Raymond acknowledged that he usually reviews three cases per
year for the respondent in Vaccine Program cases, Tr. 845, Dr. Raymond did not
appear to be providing testimony simply to advance the Secretary’s position.

In previous cases, special masters have considered Dr. Raymond thorough in
his review of a petitioner’s medical records and in providing ample support
through medical literature in composing his reports. Specifically, Dr. Raymond
discusses a petitioner’s pre-vaccination medical history in detail during his
testimony, incorporating it into his opinion. L.M. v. Sec’y of Health & Human
Servs., No. 14-714V, 2019 WL 4072130, at *14 (Fed. Cl. Spec. Mstr. July 23,
2019). Dr. Raymond closely evaluates cited medical literature. See Oliver v.
Sec’y of Health & Human Servs., No. 10-394V, 2017 WL 747846, at *27 (Fed. Cl.
Spec. Mstr. Feb. 1, 2017), mot. for rev. denied, 133 Fed. Cl. 341 (2017), aff’d, 900
F.3d 1357 (Fed. Cir. 2018), reh’g and reh’g en banc denied, 911 F.3d 1381 (Fed.
Cir. 2019). In past cases with the undersigned, he has also cogently explained
relevant medical concepts, making his testimony and opinions credible. See, e.g.,
Santini v. Sec’y of Health & Human Servs., No. 06-725V, 2014 WL 7891507, at
*1 (Fed. Cl. Spec. Mstr. Dec. 15, 2014), mot. for rev. denied, 122 Fed. Cl. 102
(2015).

2. Stephen J. McGeady

Dr. McGeady received his medical degree from Creighton University in
1967. He was a resident in pediatrics from 1970 to 1972. His fellowship was in
27
psychiatry / allergy from 1972 to 1974. Beginning in 1974, he served in various
academic positions at institutions in Philadelphia, Pennsylvania. From 1996 to
2007, Dr. McGeady was the chief of the allergy, asthma and immunology division
for duPont Hospital for Children in Wilmington, Delaware. Exhibit N (Dr.
McGeady’s curriculum vitae). He became board-certified in pediatrics in 1973.
He added a second board, allergy and immunology, in 1975. Tr. 728.

By the December 2017 hearing, Dr. McGeady had attained emeritus status,
meaning he was working 1 ½ days per week. Tr. 737. In Dr. McGeady’s career,
he had seen some children with Leigh’s syndrome but maybe not any after 1995.
Tr. 738-39.

Other special masters have regarded Dr. McGeady as well-prepared, logical,
and understandable in his testimony. Specifically, he has incorporated an
extensive knowledge of the record during his testimony. Doe/17 v. Sec’y of
Health & Human Servs., No. [redacted]V, 2008 WL 2541188, at *7 (Fed. Cl. Spec.
Mstr. May 30, 2008), mot. for rev. denied, 84 Fed. Cl. 691 (2008). Furthermore,
he is thought to present his testimony in a way that is logical and can answer
questions thoroughly and defend his positions. See Hirmiz v. Sec’y of Health &
Human Servs., No. 06-371V, 2014 WL 4638375, at *10 (Fed Cl. Spec. Mstr. Aug.
26, 2014) (“Dr. McGeady was better able to answer questions and defend his
opinion.”), mot. for rev. denied, 119 Fed. Cl. 209 (2014), aff’d, 618 F. App’x 1033
(Fed. Cir. 2015). Finally, the undersigned has regarded Dr. McGeady in the past as
“explain[ing] the basis of his opinions in an understandable way.” Jaafar v. Sec’y
of Health & Human Servs., No. 15-267V, 2018 WL 4519066, at *3 (Fed. Cl. Spec.
Mstr. Aug. 10, 2018).

3. Edward Cetaruk

Dr. Cetaruk obtained a medical degree from the New York University
School of Medicine in 1991. He became a fellow of the American College of
Medical Toxicology in 2009. Exhibit O (Dr. Cetaruk’s curriculum vitae).

The focus of Dr. Cetaruk’s work in this case was to respond to Dr.
Steinman’s theories of causation, especially the theory that alum can harm the
recipient of a vaccine. See Tr. 593. Because the details of Dr. Steinman’s alum
theory are not an issue on remand, it is not necessary to evaluate the depths of Dr.
Cetaruk’s background.

Other special masters have commented on Dr. Cetaruk’s detail-oriented
approach to his reports and testimony. Specifically, in addition to providing
28
“much greater detail in his reports” than the opposing experts, he “more coherently
and effectively communicated the basis for [his] opinions.” Bushnell v. Sec’y of
Health & Human Servs., No. 02-1648V, 2015 WL 4099824, at *15 (Fed. Cl. Spec.
Mstr. June 12, 2015). He also is not reticent to critique or strongly disagree with
opposing experts’ theories or contentions. See Rogero v. Sec’y of Health &
Human Servs., No. 11-770V, 2017 WL 4277580, at *53 (Fed. Cl. Spec. Mstr. Sept.
1, 2017), mot. for rev. denied, slip op. (Fed. Cl. Jan. 11, 2018), aff’d, 748 F. App’x
996 (2018), petition for cert. denied, 140 S. Ct. 378, 205 (2019), petition for reh'g
denied, 140 S. Ct. 656 (2019); see also Hooker v. Sec’y of Health & Human
Servs., No. 02-472V, 2016 WL 3456435, at *36 (Fed. Cl. Spec. Mstr. May 19,
2016) (“Respondent’s expert medical toxicologist, Dr. Cetaruk, was highly
persuasive in his detailed critique of Dr. Haley’s theory.”).

4. Dean Jones

Professor Jones received his Ph.D. from the Oregon Health Sciences
University in 1976. While he is not a medical doctor, the Emory University
School of Medicine appointed him to be a professor in the department of medicine
in 2003. Exhibit L (Professor Jones’s curriculum vitae).

Professor Jones is an expert in the field of oxidative stress. Tr. 633. In this
case, his task was to evaluate Dr. Niyazov’s theory that vaccines caused Trystan
oxidative stress and this oxidative stress harmed Trystan. Professor Jones did not
find support for this theory. Tr. 646, 659. However, like Dr. Cetaruk’s opinions
regarding alum, Professor Jones’s opinions about oxidative stress are outside the
scope of the remand order.

Other special masters have commented on Professor Jones’s cohesive
testimony. He has “testified knowledgeably and understandably.” Mead v. Sec’y
of Health & Human Servs., No. 03-215V, 2010 WL 892248, at *9 (Fed. Cl. Spec.
Mstr. Mar. 12, 2010). He is also thought to be “logical” in the presentation of his
theories and opinions. Dwyer v. Sec’y of Health & Human Servs., No. 03-1202V,
2010 WL 892250, at *115 (Fed. Cl. Spec. Mstr. Mar. 12, 2010). This is
particularly with respect to his expertise in the concept of oxidative stress—an area
in which his testimony has been considered very persuasive in past cases. See Bast
v. Sec’y of Health & Human Servs., No. 01-565V, 2012 WL 6858040, at *5 (Fed.
Cl. Spec. Mstr. Dec. 20, 2012), mot. for rev. denied sub. nom., M.S.B. v. Sec’y of
Health & Human Servs., 117 Fed. Cl. 104 (2014), app. dismissed, 579 F. App’x
1001 (Fed. Cir. 2014); Dwyer, 2010 WL 892250, at *115.

29
The backgrounds of the experts, particularly Doctors Steinman, Niyazov,
and Raymond, contribute to the resolution of this case.

IV. Standards for Adjudication

Petitioners are required to establish their case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of
Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &
Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).

Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1379-80
(Fed. Cir. 2009) (reversing special master's decision that petitioners were not
entitled to compensation); see also Lampe v. Sec’y of Health & Human Servs., 219
F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Human Servs., 9 F.3d
958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge’s contention that the
special master confused preponderance of the evidence with medical certainty).

Petitioners bear a burden “to show by preponderant evidence that the
vaccination brought about [the vaccinee’s] injury by providing: (1) a medical
theory causally 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.”
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).

The Althen prongs are reviewed in the sections that follow. Because the
medical theory is foundational to the claim that the DTaP vaccine harmed Trystan,
the medical theory (prong 1) is reviewed first in section V. The medical theory, in
turn, is the basis for determining the time for which an adverse reaction to the
DTaP vaccine is expected to occur. Thus, section VI addresses the appropriate
temporal relationship. As briefly explained at the end of section VI, the Sanchezes
have not persuasively demonstrated that Trystan’s neurologic problem developed
within the expected time. Thus, the Sanchezes do not meet their burden of proof
regarding prong 3. Section VII expands upon when Trystan began to manifest
neurologic problems by reviewing in detail the medical records to show that the

30
Sanchezes have not established a logical sequence of cause and effect between the
vaccination and Trystan’s Leigh’s syndrome.

V. Althen Prong 1

On remand, the parties dispute whether the remand allows for a re-
adjudication of the evidence as to whether the DTaP vaccine can cause
neurodegeneration as part of Leigh’s syndrome. Because of the procedural
posture, the remand does not permit another examination of this evidence.

A. Procedural History regarding Prong 1

The October 9, 2018 decision found the Sanchezes met their burden
regarding prong 1. The decision states:

To demonstrate that vaccinations can cause the onset of Leigh’s
syndrome, the Sanchezes provide evidence showing that the
onset of Leigh’s syndrome is associated with a decompensating
event10 and that vaccination could cause such a decompensating
event. Though a link between vaccination and the onset of
Leigh’s syndrome has not been established to the standard of
medical certainty, for the reasons elucidated below, the
evidence presented is sufficient to conclude that the Sanchezes’
theory is plausible insofar as it is consistent with contemporary
understanding of the biological systems at play. Accordingly,
the Sanchezes have met their statutory burden on this element
as the Federal Circuit has defined it. See Hibbard v. Sec’y of
Health and Human Servs., 698 F.3d 1355, 1365 (Fed. Cir.
2012) (noting that petitioners’ burden is to provide a “viable
medical theory by which a vaccine can cause the injury claimed
by the petitioner”).

Decision at 18, 2018 WL 5856556, at *11.

10
Decompensation is a period of regression that is frequently seen in cases of Leigh’s
disease. Exhibit 148 (Rahman) at 1. Dr. Raymond testified that decompensation in individuals
with Leigh’s syndrome is clinically obvious and is characterized by encephalopathy, decreased
consciousness, weakness, and motor difficulties. Tr. 794-95. Dr. Niyazov largely agreed with
this characterization of decompensation but noted that the decompensation can be followed by
periods of prolonged stabilization and possibly even improvement. See Tr. 417.

31
For a special master to find that a petitioner has met his burden with respect
to prong 1, a petitioner must provide a persuasive – not merely a “plausible” –
medical theory connecting the vaccine to the alleged injury. See Boatmon v. Sec’y
of Health & Human Servs., 941 F.3d 1351, 1357 (Fed. Cir. 2019). The Federal
Circuit has established and reaffirmed the insufficiency of the “plausibility”
standard in multiple cases. See LaLonde v. Sec’y of Health & Human Servs., 746
F.3d 1334, 1339 (Fed. Cir. 2014) (“[S]imply identifying a ‘plausible’ theory of
causation is insufficient for a petitioner to meet her burden of proof.”); Moberly v.
Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010) (rejecting
“proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and injury” as
the applicable statutory standard); see also Boatmon, 941 F.3d at 1360 (“We have
consistently rejected theories that the vaccine only ‘likely caused’ the injury and
reiterated that a ‘plausible’ or ‘possible’ causal theory does not satisfy the
standard.”).

Before the Court of Federal Claims and the Federal Circuit, the Secretary
argued that the undersigned evaluated the evidence according to the wrong
evidentiary standard. Resp’t’s Resp. to Mot. for Rev. at 9 n.10; Br. of Appellee-
Respondent at 16 n.5. In both briefs, the Secretary presented this argument in
footnotes and contended that given the findings on the other Althen prongs, any
error was “harmless.”

The Federal Circuit appeared to endorse the theory that vaccines can cause
fever and fever can cause neurodegeneration based upon its opinion in Paluck.11
Specifically, the Federal Circuit stated that “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
progressive neurological deterioration over time.” Sanchez, 809 F. App’x at 851
(citing Paluck, 786 F.3d at 1380-81).

11
The degree to which Paluck, itself, made findings regarding this theory has been
questioned. See Reed v. Sec’y of Health & Human Servs., No. 08-650V, 2018 WL 6844458, at
*90 n.150 (Fed. Cl. Spec. Mstr. Dec. 4, 2018); Pope v. Sec’y of Health & Human Servs., No. 14-
078V, 2017 WL 2460503, at *11 (Fed. Cl. Spec. Mstr. May 1, 2017) (noting that the Secretary
did not challenge prong 1 after the first remand); H.L. v. Sec’y of Health & Human Servs., No.
10-0197V, 2016 WL 3751848, at *14-15 (Fed. Cl. Spec. Mstr. Mar. 17, 2016), mot. for rev.
denied, 129 Fed. Cl. 165 (2016), aff’d, 715 F. App’x 990 (Fed. Cir. 2017).

32
B. Arguments on Remand regarding Prong 1

The undersigned directed the parties to address whether evaluation of prong
1 was required. Order, issued July 10, 2020. In response, the Secretary maintained
that nothing precludes a further analysis. Resp’t’s Remand Br. at 19. The
Secretary did not discuss either the law of the case doctrine or the mandate rule in
this context.

The Sanchezes’ initial brief was similarly undeveloped. Also without citing
any authority, the Sanchezes maintained that reevaluation of prong 1 is precluded.
Pet’rs’ Remand Br. at 85. But, the Sanchezes expanded those arguments in reply. 12
They contended that noting an objection does not elevate an appellate issue and the
Secretary did not file his own appeal regarding prong 1. Thus, in the Sanchezes’
view, the lack of appellate pursuit of this issue by the Secretary amounts to a
waiver of any argument. Pet’rs’ Reply on Remand at 23-24.

C. Resolution

Preliminarily, the Sanchezes’ suggestion that the Secretary was required to
file an appeal appears misplaced. See Aventis Pharma S.A. v. Hospira, Inc., 637
F.3d 1341 (Fed. Cir. 2011) (granting motion to strike a cross-appeal that did not
seek to expand the putative cross-appellant’s rights under the judgment).
However, the Sanchezes’ comments regarding how the Secretary presented his
“harmless error” argument---in a footnote to the Federal Circuit---may be more
meaningful. See SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312,
1320 (Fed. Cir. 2006) (explaining an argument needs to be developed, not just in a
footnote). Regardless, the undersigned trusts that the Federal Circuit considered
the Secretary’s arguments regarding prong 1. See Allapattah Services, Inc. v.
Exxon Corp., 372 F. Supp. 2d 1344, 1364 (S.D. Fla. 2005) (“This Court will not
presume that the Circuit panel completely disregarded an argument specifically
raised on appeal”). Furthermore, the doctrine of the law of the case, which
precludes relitigation of issues explicitly or implicitly decided on appeal, sheds
light on implicit appellate considerations of arguments. See Travelers Ins. Co. v.
United States, 72 Fed. Cl. 316, 325 (2006) (“The doctrine [of the law of the case],
of course does not constrain a trial court’s consideration of an issue that has not
been considered on appeal. [] But the doctrine extends to issues that were
implicitly addressed.” (citing W.L. Gore & Assocs., Inc. v. Garlock, Inc., 842 F.2d

12
The Secretary’s reply did not address the mandate rule in the context of prong 1.

33
1275, 1278 (Fed. Cir. 1988) (“The doctrine [of the law of the case] applies not only
to issues discussed and decided but also those decided by necessary
implication.”))); American Satellite Co. v. United States, 34 Fed. Cl. 468, 480
(1995) (“Although the opinion issued by the Federal Circuit did not address the
waiver question . . . further consideration of this issue is precluded by the appellate
decision. . . . [T]he law of the case doctrine applies to issues implicitly decided by
the appellate court.”).

“Upon return of its mandate, the district court cannot give relief beyond the
scope of that mandate, but it may act on matters left open by the mandate.”
Laitram Corp. v. NEC Corp., 115 F.3d 947, 951 (Fed. Cir. 1997) (quoting Caldwell
v. Puget Sound Elec. Apprenticeship & Training Tr., 824 F.2d 765, 767 (9th Cir.
1987)) (internal quotation marks omitted). Here, the Federal Circuit’s mandate
does not indicate that the undersigned should reconsider the findings regarding
prong 1 in the October 9, 2018 decision. Indeed, if anything, the Federal Circuit
seems to be agreeing with the outcome reached in the October 9, 2018 decision on
prong 1.

Accordingly, the finding in the October 9, 2018 decision remains
undisturbed. The theory that the DTaP vaccine can cause neurodegeneration,
potentially through the intermediate step of a fever, is sound and reliable under
prong 1.

VI. Althen Prong 3

“[T]he proximate temporal relationship prong requires preponderant proof
that the onset of symptoms occurred within a timeframe for which, given the
medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347,
1352 (Fed. Cir. 2008). Thus, the third prong of Althen implicitly has two parts. A
petitioner must show the “timeframe for which it is medically acceptable to infer
causation” and that the onset of the disease occurred in this period. Shapiro v.
Secʼy of Health & Human Servs., 101 Fed. Cl. 532, 542-43 (2011), recons. denied
after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d without op., 503 F.
App’x 952 (Fed. Cir. 2013).

As explained in section A, below, the parties have disputed both parts of
prong 3. Thus, the procedural history of the parties’ arguments on prong 3 are set
forth in detail. The procedural history shows that the appropriate temporal
relationship that was found in the October 9, 2018 decision was not disturbed on
appeal. For reasons described in section B, below, this remand decision again
34
finds the same appropriate temporal relationship between a vaccination and the
onset of neurologic deterioration.

A. Procedural History regarding Prong 3

The October 9, 2018 decision discussed evidence regarding the appropriate
timing between a decompensating event and the onset of neurologic symptoms,
including Edmonds (exhibit 75), Shoffner (exhibit 86), and the Poling case report
(exhibit 54). See Joseph L. Edmonds et al., The Otolaryngological Manifestations
of Mitochondrial Disease and the Risk of Neurodegeneration With Infection, 128
Arch Otolaryngol Head Neck Surg. 355 (2002), filed as exhibit 75; John Shoffner
et al., Fever Plus Mitochondrial Disease Could Be Risk Factors for Autistic
Regression, 254 J. Child Neurology 429 (2010), filed as exhibit 86; Jon S. Poling
et al., Developmental Regression and Mitochondrial Dysfunction in a Child With
Autism, 21 J. Child Neurology 170 (2006), filed as exhibit H-15. While these
articles “are far from comprehensive,” they suggested that neurodegeneration
would occur within approximately two weeks. Decision at 26, 2018 WL 5856556,
at *16. However, the October 9, 2018 decision attempted to avoid setting a “hard
and fast deadline,” which would conflict with the dictate in Paluck, 786 F.3d at
1383. Accordingly, the October 9, 2018 decision did not specify the outside time
frame at which neurodegeneration could appropriately be linked to an antecedent
event. But, the October 9, 2018 decision found that the Sanchezes failed to
establish that they were entitled to compensation because of (a) the length of time
between the February 5, 2009 vaccination and the onset of Trystan’s
neurodegeneration, which started no earlier than May 1, 2009 (almost three months
later), and (b) infections that Trystan suffered much closer in time to the onset of
his neurodegeneration.

In their motion for review, the Sanchezes challenged the evaluation of the
appropriate temporal relationship. 13 The Sanchezes argued that the October 9,
2018 decision violated Paluck, interpreted the Edmonds article incorrectly, and
ignored (or overlooked) the testimony of Dr. Niyazov that a fade response could
extend the appropriate temporal relationship out to two or three months. Pet’rs’
Mot. for Rev. at 20-25. In reply, the Sanchezes added an argument that the

13
This aspect of the Sanchezes’ argument corresponds to the first part of Althen prong 3.
The Sanchezes also presented arguments about the second part of Althen prong 3, when Trystan
began to suffer neurodegeneration. Those are addressed in sections VI.B & VI.C below.

35
October 9, 2018 decision conflicted with Paluck in that the undersigned relied
upon small studies.

In denying the Sanchezes’ motion for review, the Court of Federal Claims
rejected the Sanchezes’ arguments. In particular, the Court of Federal Claims
ruled that the undersigned did not violate Paluck because the decision did not set a
hard and fast deadline. The Court further ruled that the special master did not have
to accept the Sanchezes’ argument that the appropriate temporal relationship could
extend to two or three months. Opinion and Order at 255-56.

On appeal to the Federal Circuit, the parties’ arguments with respect to the
appropriate temporal relationship largely, if not entirely, matched their arguments
to the Court of Federal Claims. For example, the Sanchezes again argued that the
special master ignored Dr. Niyazov’s testimony about the Naviaux article. The
Sanchezes also argued that the October 9, 2018 decision erroneously set a hard and
fast deadline, in violation of Paluck.

In disagreement with the Sanchezes’ arguments, the Federal Circuit ruled
that the decision was in accord with Paluck. The Federal Circuit did not comment
upon the usefulness of the Naviaux article. However, the Federal Circuit
remanded for a separate analysis of prong 2 and prong 3. The Federal Circuit
required that the undersigned find whether Trystan’s February 16, 2009 arm
contortions could contribute to finding that the Sanchezes met their burden with
respect to Althen prong 3.

On remand, the parties were instructed to present arguments regarding both
parts of Althen prong 3. Order, issued July 10, 2020. For the temporal interval for
which an inference of causation is appropriate (part 1), the parties appeared to
struggle to set any bounds. Copying from their July 7, 2017 pre-hearing brief, the
Sanchezes argued that neurodegeneration would often occur within two weeks,
possibly three weeks after the inciting event. Pet’rs’ Remand Br. at 53-64. The
Secretary did not specify an appropriate amount of time, other than to maintain that
“several months” is too long. Resp’t’s Remand Br. at 20. In reply, the Sanchezes
presented very little, if anything, about the appropriate temporal relationship. See
Pet’rs’ Remand Reply at 10-14 (discussing prong 2).

B. Analysis of Althen Prong 3, part One

At its foundation, Althen requires “a showing of a proximate temporal
relationship between vaccination and injury.” 418 F.3d at 1278. Subsequent
Federal Circuit cases have developed aspects of this element. For example,
36
Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1358 (Fed. Cir. 2006),
explained “[i]f, for example, symptoms normally first occur ten days after
inoculation but petitioner’s symptoms first occur several weeks after inoculation,
then it is doubtful the vaccination is to blame.” Id. de Bazan linked the medically
acceptable timeframe to the “medical understanding of [a] disorder’s etiology.” de
Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).
In accord with these precedents, special masters may reject an opinion that is so
indefinite about the appropriate temporal relationship that the opinion would
effectively render the third Althen prong a nullity. Hennessey v. Sec’y of Health
& Human Servs., 91 Fed. Cl. 126, 141-42 (2010). Similarly, special masters may
find that when the onset of a disease occurs outside the expected temporal interval,
petitioners are not entitled to compensation. Greene v. Sec’y of Health & Human
Servs., No. 11-631V, 2019 WL 4072110, at *21 (Fed. Cl. Spec. Mstr. Aug. 2,
2019), mot. for rev. denied, 146 Fed. Cl. 655 (2020).

While those cases suggest that sometimes the interval between the
vaccination and the onset of symptoms is too long to support a finding of
causation-in-fact, Paluck cautions against defining the limits too rigidly. With this
guidance, the undersigned attempted to point out that the evidence, imperfect as it
might be, seemed to coalesce around a finding that two weeks from vaccination to
the onset of neurologic decline is an interval that would support a finding of
causation.14 Decision at 25, 2018 WL 5856556, at *15. Yet, at the same time, the
undersigned tried to balance what the evidence showed with Paluck’s recognition

14
The Sanchezes’ criticism that the undersigned erred in relying upon small studies, see
Pet’rs’ Reply in Support of Mot. for Rev. at 11-12; see also Pet’rs’ Mot. for Rev. at 31
(highlighting the portion of Paluck that identifies the Shoffner and Edmonds articles, and Poling
case study, as not establishing a definitive time frame due in part to small patient sample sizes);
Pet’rs’ Remand Br. at 63 (same), seems misplaced in that the Sanchezes introduced the studies,
such as Edmonds and Shoffner, on which the undersigned relied. Special masters have
commented that they base decisions on studies with small samples because “[e]vidence from
small studies may be the only evidence available to support or undercut an opinion on
causation.” Holt v. Sec’y of Health & Human Servs., No. 05-0136V, 2015 WL 4381588, at *30
n.84 (Fed. Cl. Spec. Mstr. June 24, 2015); see also H.L. v. Sec’y of Health & Human Servs., No.
10-0197V, 2016 WL 3751848, at *11 (Fed. Cl. Spec. Mstr. Mar. 17, 2016) (“[T]he Edmonds
study remains the only evidence in this record regarding the expected timing of a neurologic
deterioration[.]”), mot. for rev. denied, 129 Fed. Cl. 165, 175-76 (2016) (rejecting argument that
special master erroneously relied upon Edmonds), aff’d, 715 F. App’x 990, 997 (Fed. Cir. 2017)
(“The special master’s ‘requirement for strong temporal evidence’ in this regard does not
contravene Paluck and is ‘consistent with the third prong of the Althen test.’”).

37
that more studies would be helpful. Cf. Sharpe v. Sec’y of Health & Human
Servs., 964 F.3d 1072, 1083 (Fed. Cir. 2020) (criticizing special master for noting
that different evidence could lead to a different result).

On appeal, the Federal Circuit did not correct this approach. Because the
mandate does not remand for reconsideration of the first part of Althen prong 3, the
undersigned will again primarily look for evidence of neurologic decline within
two weeks of the vaccination. However, if Trystan’s neurologic decline were to
occur slightly outside of two weeks, then the Sanchezes could meet their burden
regarding Althen prong 3.15

C. Analysis of Althen Prong 3, part Two

The ensuing question, a topic of the Federal Circuit’s remand, is whether the
Sanchezes presented persuasive evidence that Trystan began to suffer lasting
neurologic problems within approximately two weeks of the vaccination. 16 The
short answer is that the Sanchezes have not. When the record is considered as a
whole, the symptoms that Trystan displayed on February 5, 2009, as well as on
February 15-16, 2009, including his arm contortions, are not manifestations of a
neurologic disorder. The longer answer and more detailed explanation are
provided as part of the prong 2 analysis below.

VII. Althen Prong 2

On remand, the procedural history of the arguments regarding prong 2,
which is set out in section A, again complicate the issues. A chief question is
when Trystan started to experience neurodegeneration because if, as the
Sanchezes’ theory predicts, Trystan developed neurodegeneration within a short
time (approximately two weeks) after the vaccination, then a “logical” conclusion
might be that the vaccination caused the neurodegeneration. This argument is

15
Even if the Federal Circuit remanded the question of Althen prong 3, part 1, the
undersigned would still find that the evidence weighs in favor of finding that neurodegeneration
would occur within approximately two weeks from an allegedly inciting event. Even Naviaux
indicates that the fade response is “typically delayed two to ten days after a fever.” Tr. 438 (Dr.
Steinman).
16
The qualification of “lasting” problems refers to the requirement that petitioners must
establish that an injury persisted longer than six months. 42 U.S.C. § 300aa-11(c)(1)(D). As
such, while the vaccination caused Trystan to have a fever and to cry inconsolably, this initial
and transient reaction is not compensable.

38
developed in section B, which restates the theory the Sanchezes and their experts
advance. Section B also includes a detailed analysis of Trystan’s health at various
times, corresponding to visits to medical providers. Section B ultimately presents
the finding that Trystan’s neurodegeneration began later than the time predicted by
the Sanchezes’ theory. Within this section on the logical sequence of cause and
effect (section V), there is an analysis of reports from doctors who treated Trystan
because the reports of treaters may influence the outcome on prong 2.

A. Procedural History regarding Logical Sequence of Cause and
Effect / Onset of Neurodegeneration

As discussed above with respect to prong 3, the October 9, 2018 decision
found that the Sanchezes failed to establish that the DTaP vaccination caused
Trystan’s neurologic problems because Trystan lost skills no earlier than May or
June 2009, which was too long after the February 5, 2009 vaccination to infer
causation-in-fact and because Trystan suffered infections in April and May.
Decision at 22-24, 2018 WL 5856556, at *13-15.

In their motion for review, the Sanchezes argued that the undersigned was
arbitrary in that the October 9, 2018 decision failed to address their position that
the neurodegeneration began immediately after the February 5, 2009 vaccination
when Trystan had a fever, inconsolable crying, and a hot spot on his leg. Pet’rs’
Mot. for Rev. at 32. Specifically, the Sanchezes argued that the undersigned did
not adequately address Dr. Steinman’s and Dr. Niyazov’s contentions that “fever,
irritability, and other signs” were indicators of the onset of neurodegeneration as
part of a development process that does not adhere to a “rigid timeframe for when
the clinical symptoms of vaccine-induced neurodegeneration would be expected to
appear.” Id. Similarly, in their motion, the Sanchezes added that the undersigned
improperly ignored evidence that Trystan faded after the vaccination. See id. at
10.

The Court did not accept the Sanchezes’ arguments. The Court ruled that
the Sanchezes were suggesting that the undersigned wrongly weighed evidence
regarding the onset of neurodegeneration. The Court, accordingly, determined that
such an argument about re-weighing evidence was not acceptable and denied the
motion for review on this point. Opinion and Order at 254.

At the Federal Circuit, the Sanchezes returned to the issue of when Trystan’s
neurodegeneration began. The opening section of their initial brief as well as the
opening section of their reply brief is devoted to the topic of the onset of
neurodegeneration. Br. of Appellants-Petitioners at 4; Reply of Appellants-
39
Petitioners at 1. They argued that Trystan’s crying and fever marked the beginning
of his neurodegeneration. Br. of Appellants-Petitioners at 34; Reply of Appellants-
Petitioners at 7. They also compared Trystan to the children in Markovich and
Paluck.

The Federal Circuit did not directly address whether Trystan’s fever and
crying from the day and evening after the February 5, 2009 vaccination constituted
a manifestation of neurodegeneration. However, the Federal Circuit remanded for
consideration of whether Trystan’s February 16, 2009 arm contortions were a
manifestation of a neurological injury. Sanchez, 809 F. App’x at 853.

On remand, the Sanchezes’ position with respect to onset is not thoroughly
consistent. The Sanchezes primarily advance the position that Trystan’s fever and
inconsolable crying on February 5, 2009, were the first manifestation of his
neurologic injury. Pet’rs’ Remand Br. at 42. They fault the October 9, 2018
decision for not addressing their claim that Trystan’s fever, irritability, and
potential encephalopathy are the onset of his neurologic disorder. Id. at 49. They
go so far as to argue that the undersigned’s Remand Decision must address the
fever, inconsolable crying, and arm contortions. Id. at 51. However, by quoting
Dr. Steinman’s June 15, 2020 report, the Sanchezes also state that the February 16,
2019 arm contortions are “evidence of the onset of neurodegeneration.” Id. at 13-
14 (quoting exhibit 185).

The Secretary’s argument with respect to Trystan’s onset of neurologic
problems focuses on Trystan’s behavior on February 16, 2009. The Secretary
appears not to address Trystan’s behavior on February 5, 2009. Resp’t’s Remand
Br. at 19-21; see also Br. of Appellee-Respondent at 17, 24 (attributing all
Trystan’s problems in February 2009 to a cold).

In the sections that follow, the undersigned will address Trystan’s neurologic
status at different periods, including February 5, 2009; February 16-17, 2009; the
end of February through early April 2009; April-May 2009; August 2009; and
October-December 2009. As part of the final section (October-December 2009),
the undersigned will discuss challenge-rechallenge. The undersigned will also
address the contributions of treating doctors in this case and evaluate their
relevance and weight in analyzing the Sanchezes’ claim. But, the analysis of
Althen prong 2 begins with a recapitulation of the Sanchezes’ theory of how the
DTaP vaccine can harm Trystan.

40
B. Summary of Causal Theory

The second element in Althen’s formulation of elements to establish
causation-in-fact is “a logical sequence of cause and effect showing that the
vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. A “logical”
sequence suggests that the vaccinee responded in a way consistent with the causal
theory. For example, when a petitioner presents a theory that a vaccine can attack
the autonomic nerves, the special master may find against the petitioner due to the
lack of preponderant evidence showing an autonomic neuropathy. Hibbard v.
Sec’y of Health & Human Servs., 698 F.3d 1355, 1364 (Fed. Cir. 2012); see also
Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. 43, 54 (2013)
(“Petitioner’s argument fails because . . . the Chief Special Master tested the
proposed mechanism of causation . . . and found that the proposed mechanism, as
applied to the facts of S.S.’s seizures . . . failed to provide a logical sequence of
cause and effect.”); La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl.
184, 205 (2013) (affirming a special master’s determination that the non-existence
of an asserted condition constituted a “missing link” in the Althen prong 2
causation analysis), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). Thus, a petitioner’s
causal theory affects whether the evidence offered in an attempt to show “that the
vaccination was the reason for the injury” is “logical.”

Here, through opinions of their experts and arguments of their attorney, the
Sanchezes maintain that Trystan’s response to the vaccine changed his life. After
the vaccination, Trystan started “a downward cascade.” Tr. 278 (Dr. Steinman).
Dr. Steinman confirmed his opinion in his testimony on remand. Tr. 2033-34. He
saw Trystan’s deterioration as “one continuous process”, Tr. 294, and “evolving in
a continuum,” Tr. 296-97. “[T]he dynamic effect of the shot was to create damage
in the nervous system which, as the child developed, became apparent at different
points with losing skills and other manifestations.” Tr. 295. Dr. Steinman further
stated that, while there are various reasons a child’s loss of skills may be subtle, at
a certain point in Trystan’s medical history, doctors began noting concrete and
serious loss of milestones, which “didn’t happen overnight.” Tr. 296. On remand,
Dr. Steinman characterized Trystan as taking a “big hit” in February. Tr. 2042.

Dr. Niyazov wrote that Trystan’s “developmental regression was slowly
developing ever since the crying and fever took place as a result of the
vaccination.” Exhibit 68 at 8. Dr. Niyazov testified that the vaccination and its
associated inflammation took energy from Trystan from which he could not
recover for two to three months. Tr. 415-16. Dr. Niyazov testified that Trystan’s

41
Leigh’s syndrome started with the fever and inconsolable crying on February 5,
2009. Tr. 457.17

In addition to presenting this testimony from their experts, the Sanchezes
analogize their case to two cases, Markovich and Paluck, which reached the
Federal Circuit. They also compare their case to Poling. Thus, a review of the
facts in those cases is appropriate.

Markovich

Ashlyn Markovich received a set of vaccinations, including the DTaP
vaccine, on July 10, 2000. Markovich v. Sec’y of Health & Human Servs., No. 03-
2015V, 2005 WL 6117470, at *1 (Fed. Cl. Spec. Mstr. July 22, 2005). Later that
day, Ashlyn started to blink her eyes “repeated[ly].” Id. Supported by an affidavit,
the petition alleged that “after Ashlyn’s July 10, 2000 vaccinations and continuing
to August 30, 2000, the parents observed Ashlyn rapidly blinking her eyes.” Id. A
pediatric neurologist who testified for the petitioners, Jean-Ronel Corbier, accepted
the assertions contained in the affidavit. Dr. Corbier opined that “[T]here is a
possibility that these rapid frequent eye blinking episodes may have represented
seizures.” Id. at *1 n.9. Another doctor, Donald H. Marks, opined that the DTaP
vaccination caused the development of the seizure disorder. Id. at *1 n.8.
“Ashlyn’s first full-blown seizure . . . occur[ed] [on] August 30 or 31, 2000.” Id.
at *1.

To determine whether the petition, which was filed on August 29, 2003, was
filed within the three-year statute of limitations, the special master held a hearing
during which the only person to testify was Dr. Corbier. Id. at *2. “Dr. Corbier
explained that although rapid eye blinking alone is insufficient to establish a
seizure disorder diagnosis, as a neurologist, the eye blinking episode would have
raised his suspicions and he would have pursued further investigation[.]” Id. at
*11. Dr. Corbier also made “plain that the eye blinking episodes were part of a
progression of symptoms.” Id. In opining that the July 10, 2000 DTaP vaccination

17
Later, on remand, Dr. Niyazov stated that this testimony was not accurate. Dr.
Niyazov stated that Trystan’s Leigh’s syndrome began on December 15, 2009, when he
underwent an MRI, because an MRI is only mechanism by which Leigh’s syndrome could be
diagnosed. Tr. 2072-73. He stated that he may have misspoke at the original entitlement hearing
by making “a common error where when people sometimes have interchangeable use of the
words mitochondrial complex II deficiency and Leigh’s disease.” Id. 2072. This remand
testimony from Dr. Niyazov was confusing and not persuasive.

42
caused the August 30, 2000 seizure, “Dr. Corbier explained that if there had been
no evidence of brain dysfunction between July 10, 2000, and August 30, 2000, it
would be more difficult to prove that the vaccinations Ashlyn received on July 10,
2000, were the cause of her seizure disorder.” Id. at *13.

Dr. Corbier’s opinion about the significance of the eye blinking episodes
was “critical to the special master’s decision.” Id. The special master found that
because Ashlyn manifested some neurologic problem on July 10, 2000, the statute
of limitations began to run on that day. The special master rejected the petitioners’
arguments that because they did not recognize until later the significance of the eye
blinking episodes, the statute of limitations should not start running until August
30, 2000. Id. at *14. Therefore, despite sympathy for the Markoviches, the special
master found that the statute of limitations barred the petition. 18

In the present case, the Sanchezes compare Trystan to Ashlyn. To the
Sanchezes, Trystan’s “fever, hot spot, and inconsolable crying” are the onset of his
neurological disorder just as Ashlyn’s eye blinking marked a manifestation of her
seizure disorder. To continue the analogy, the Sanchezes state Trystan’s “loss of
skills in May 2009 is similar to the grand mal seizure.” Pet’rs’ Remand Br. at 43.

However, Trystan and Ashlyn differ. The differences are apparent in at least
two ways. First, in Markovich, Dr. Corbier accepted the parental account that
Ashlyn had repeated and frequent episodes of eye blinking between the day of
vaccination and the August 30, 2000 seizure. The numerous instances allowed Dr.
Corbier to see a “progression of symptoms.”19 In contrast, Trystan did not display
any neurologic problems for weeks after the February 16, 2009 incident.

Second, in Markovich, Dr. Corbier’s opinion that the eye blinking
constituted a manifestation of a neurologic disorder was unopposed. Here, while
Dr. Steinman and Dr. Niyazov maintain that Trystan’s neurodegeneration began on

18
The Court of Federal Claims ruled that the special master’s reliance on Dr. Corbier’s
testimony was not arbitrary and denied the petitioners’ motion for review. 69 Fed. Cl. 327
(2005). The Federal Circuit affirmed. 477 F.3d 1353 (Fed. Cir. 2007).
19
In evaluating the motion to dismiss for failure to file within the time the statute of
limitations permits, the special master seemed to accept the reliability of the affidavit. The
Secretary, however, noted that “there is no mention in the medical records of Ashlyn’s eye
fluttering.” Markovich, 2005 WL 6117470, at *2.

43
February 5, 2009, Dr. Raymond opposes this opinion. This point is developed
further below.

Paluck

The Sanchezes often compare their case to Paluck. See, e.g., Pet’rs’ Pre-
hear’g Br., filed July 7, 2017, at 17-19, 46-50; Pet’rs’ Mot. for Rev., filed Nov. 8,
2018, at 20-32; Br. of Appellants-Petitioners at 18-19, 23, 28, 35-48; Pet’rs’
Remand Br. at 61-64. Therefore, a brief (not exhaustive) review of the facts of
Paluck is appropriate.

The vaccinee in Paluck was a child named Karl Paluck. He most likely was
born with a mitochondrial disorder. Paluck v. Sec’y of Health & Human Servs.,
113 Fed. Cl. 210, 213 (2013), aff’d, 786 F.3d 1373 (Fed. Cir. 2015). Before
vaccinations around his first birthday in January 2005, Karl was diagnosed with
developmental delays in various domains. Id. at 214. Within two days of the
vaccinations, his daycare provider documented that Karl was running a fever, was
irritable, and had fatigue. Id. at 216. Within the next two weeks, Karl “was often
fussy, did not eat or nap well, and was tired.” Id. at 217.

About three weeks after vaccination, Karl’s parents brought him to a
chiropractor because Karl was having problems sitting, crawling, and walking. Id.
Over the next two months, the chiropractor recorded a series of variable subjective
assessments about Karl’s abilities. Id.

By April 2005, Karl’s pediatrician and a pediatric neurologist to whom Karl
had been referred were identifying worse problems with Karl. In short, Karl was
experiencing “global delayed development.” Id. at 218. He further deteriorated
from April to July. Id. at 219. In July, Karl had a seizure and an MRI suggested
that Karl was suffering from neurodegeneration. Id.

The Court found that the Palucks’ case should be analyzed as a significant
aggravation case, not a new injury case. Id. at 228. The Court then applied the six
elements from Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144
(2009).

With respect to the sixth Loving factor, which corresponds to Althen prong
3, the Court declined to set “a hard and fast time frame” for which a vaccination
would aggravate a mitochondrial disorder. Paluck, 113 Fed. Cl. at 240.
Nevertheless, the Court recognized that, at a minimum, the experts agreed that a
change would begin “within a few weeks.” Id. (quoting testimony from the
44
Secretary’s expert). The experts’ opinions derived, in part, from the Edmonds
article, the Shoffner study, and the Naviaux commentary on the Shoffner study.

The Court found that the Palucks had established their burden of showing
that Karl experienced neurodegeneration within this period. The Court credited the
testimony of the Palucks’ expert who relied upon a relatively early notation by the
chiropractor that Karl was “spastic” on February 11, 2005. According to the
Court, “[s]tarting with this chiropractic notation, the record shows that Karl
experienced a general decline.” Id. Karl exhibited various issues continually
before and after vaccination, including developmental delays, bouts of otitis media
and erythema multiforme, neuromuscular issues, global developmental delay, and
skin lesions. Id. at 213-18.

Poling

Through Dr. Niyazov, the Sanchezes have compared Trystan to Hannah
Poling. See Pet’rs’ Pre-hear’g Br., filed July 7, 2017, at 47-50; Pet’rs’ Mot. for
Rev., filed Nov. 8, 2018, at 26, 31; Pet’rs’ Reply in Support of their Mot. for Rev.
at 11-12.20 While the Poling case carries some renown in the Vaccine Program, the
events in Hannah Poling’s life should be reviewed again.

At age 19 months, Hannah Poling received multiple vaccinations, including
the diphtheria-tetanus-pertussis and varicella vaccines. Within 48 hours, she
developed a fever, inconsolable crying, irritability, and lethargy, and refused to
walk. Four days later, she could not walk up stairs normally. Over the next three
months, she was “irritable and increasingly less responsive verbally, after which
the patient’s family noted clear autistic behaviors.” Exhibit H-15 (Poling) at 170.21

Hannah’s parents sought compensation through the Vaccine Program.22 The
Secretary conceded that the Polings were entitled to compensation because

20
In these contexts, the Sanchezes also rely upon the Court’s citation to Poling in Paluck.
21
The Poling case report as published in the Journal of Child Neurology appears as
exhibit H-18. A manuscript version was filed as exhibit 84.
22
Hannah’s father, Dr. Jon Poling, later stated that he “should have declared [his]
daughter’s identity in a separate letter to [Journal of Child Neurology].” Poling 2008, filed as
exhibit 118. Dr. Poling’s co-authors wrote separately to indicate that “a full disclosure of the
relationship of the patient to the lead author and the submission of the case to the Vaccine
Adverse Event Report System and the U.S. Vaccine Injury Compensation Program should have
been made to the journal prior to publication.” Exhibit 118 and exhibit H-18. The editor-in-
45
Hannah’s case met the Table’s definition of encephalopathy. Poling v. Sec’y of
Health & Human Servs., No. 02-1466V, 2011 WL 678559 (Fed. Cl. Spec. Mstr.
Jan. 28, 2011) (awarding attorneys’ fees and costs); see also R.K. v. Sec’y of
Health & Human Servs., No. 03-0632V, 2015 WL 10911950, at *14-17 (Fed. Cl.
Spec. Mstr. May 23, 2016) (describing Poling case), mot. for rev. denied, 125 Fed.
Cl. 57 (2016), aff’d, 671 F. App’x 792 (Fed. Cir. 2016).

Comparing Trystan and Hannah is difficult. To start, because Hannah was
19 months old when she received the vaccinations, she was capable of climbing
stairs, walking, and some talking. Thus, the loss of these abilities would be more
noticeable to a parent. In contrast, Trystan’s abilities as a six-month-old child
would naturally be more limited.

Even so, Hannah’s father reported to the Journal of Child Neurology that
Hannah’s abilities deteriorated in the three months after vaccination. In this time,
she became “increasingly less responsive verbally.” Within the first few weeks
after receiving her vaccination, Hannah experienced episodes of opistho-tonus
whereby she would not be able to walk up stairs normally, low-grade intermittent
fever, and generalized erythematous muscular rash. Exhibit 84 at 2.

These examples to which the Sanchezes compare Trystan are a foundation
for examining what happened to Trystan. This analysis begins with Trystan’s
health on the day of his vaccination.

1. February 5, 2009

Trystan was taken to his six-month well-baby checkup with Dr. Philip
Brown on February 5, 2009. Exhibit 1 at 44. Dr. Brown found his growth and
development to be normal. Id. at 46. As identified by Dr. Steinman as part of his
hearing testimony, normal developmental milestones for a 6-month-old include
exchanging things from one hand to another, sitting, interacting, smiling, laughing,
engaging, and cooing. Tr. 2052. Six-month milestones also include sitting up and
supporting themselves, also referred to as a “lateral prop.” Tr. 2053-54. Dr.
Brown noted that Trystan was meeting his developmental milestones, including:
turning to sound, self-feeding, self-comforting, responding to his name, sitting with
support, grasping and mouthing objects, smiling, laughing, squealing, showing

chief of the Journal of Child Neurology also stated that the authors should have disclosed
conflict of interest. Exhibit H-18.

46
interest in toys, showing differential recognition of parents, babbling reciprocally,
rolling over from back to front, and standing when placed. Exhibit 1 at 46.
Trystan also had “no head lag when pulled to sit.” Id. On this day, he received the
DTaP, hepatitis B, Haemophilus influenzae type B, inactivated polio, and
pneumococcal conjugate vaccines. Id. Dr. Brown recommended that Trystan
return in two months to receive further vaccinations. Id.; see also Ruling Finding
Facts ¶ 6.

After the wellness check with Dr. Brown, Trystan was inconsolable; he cried
a loud, high-pitched cry, as if he was in pain. Tr. 18-19, 67, 177-79. He began to
run a temperature of 102.2 degrees and developed a lump on his left thigh that was
“really hot.” Tr. 17-20, 32, 67-69, 113, 177-79. Ms. Sanchez gave Trystan
Tylenol for the fever, which ebbed and flowed over the next few days. Tr. 20, 30,
68, 151, 178, 180; see also Ruling Finding Facts ¶ 6.

From this date, three facts about Trystan are the basis for much of the
Sanchezes’ experts’ opinions. These facts are Trystan’s inconsolable crying, his
fever, and the hot spot on his thigh. Tr. 412, 420, 453. Of these three facts, the
most important is the inconsolable crying.

Inconsolable crying can be a manifestation of an encephalopathy or injury to
the nervous system. See Estep v. Sec’y of Health & Human Servs., No. 90-1062V,
1992 WL 357811, at *3 (Fed. Cl. Spec. Mstr. Nov. 3, 1992), mot. for rev. denied,
28 Fed. Cl. 664 (1993); Tr. 2020 (Dr. Steinman). Dr. Steinman, in particular, cited
to the package insert for the pertussis vaccine as a way to demonstrate that
Trystan’s crying was a manifestation of a neurologic disorder. Tr. 257, 261, 282,
2020; see also Tr. 492 (Dr. Niyazov), 873-75 (Dr. Raymond). Dr. Raymond
recognized that high-pitched crying can be compatible with an “encephalopathy,”
as defined in the Vaccine Injury Table. However, the high-pitched crying is not
diagnostic for a Table encephalopathy. Tr. 861, 918. 23

Inconsolable crying does not have to be a manifestation of a neurologic
injury. See Cox v. Sec’y of Health & Human Servs., No. 90-1673V, 1997 WL
101594, at *1 (Fed. Cl. Spec. Mstr. Feb. 18, 1997); 42 C.F.R. § 100.3(c)(2)(i)(C)

23
The relevant Table definition of “encephalopathy” required petitioners to establish that
the vaccinee suffered, among other criteria, a loss of consciousness. 42 C.F.R. § 100.3(b)(2)
(2008). Although Dr. Steinman seemed to equivocate about answering a question regarding
Trystan’s consciousness, Tr. 2036, Trystan did not suffer a loss of consciousness following the
vaccination. Tr. 859, 869, 2119.

47
(2017) (stating “high-pitched and unusual screaming” does not demonstrate an
“acute encephalopathy” as defined in the Vaccine Injury Table). As Dr. Steinman
pointed out during the December 2017 hearing, infants sometimes cry for hours
during a flight. Tr. 288. The Secretary’s experts, Dr. McGeady and Dr. Raymond,
testified that Trystan’s inconsolable crying the day of the vaccination reflected
Trystan’s discomfort and pain after receiving an injection. Tr. 729-30, 762, 872,
2141.24

Likewise, the presence of a fever is non-specific. As the October 9, 2018
decision recognized, the experts appeared to agree that vaccines can cause an
elevation in temperature and the February 5, 2009 vaccination caused Trystan’s
fever later that day. Tr. 412 (Dr. Niyazov).

The finding that the vaccine caused Trystan’s February 5, 2009 fever, which
ebbed and flowed for a few days, does not necessarily mean that Trystan
experienced a prolonged abnormal reaction to the vaccine. A fever is part of the
body’s normal physiology. Tr. 945. D

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/4567817. Public record. Not legal advice.