Judges: Christian J. Moran
Filed: Sep. 22, 2020
Latest Update: Sep. 22, 2020
Summary: 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
Summary: 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 ..
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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 F.
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. Dean Jones, a leading expert on oxidative
stress, stated an assertion that “fever, per se, is oxidative stress . . . is completely
ludicrous.” Tr. 681. Fever can be evidence of an immune response but need not
be. Tr. 762 (Dr. McGeady).
Finally, the presence of a red mark on Trystan’s thigh carries the least
significance as even Dr. Steinman and Dr. Niyazov placed little emphasis on it.
24
The Sanchezes appear to overlook the distinction between their experts and the
Secretary’s experts about the etiology of Trystan’s inconsolable crying on February 5, 2009. Dr.
Niyazov associated Trystan’s crying and fever with an inflammatory (or immunological)
response to the vaccine. Tr. 453. Dr. McGeady associated the crying with a painful response to
the vaccine. Tr. 730. It is not correct to argue that because Dr. McGeady testified that the
vaccine caused Trystan’s crying, Dr. McGeady has agreed with the Sanchezes’ theory that the
vaccine caused a lasting harm. See Pet’rs’ Remand Br. at 13 (citing Tr. 728-29). Dr. McGeady
merely testified as to the crying occurring as an immediate reaction, more as a co-occurrence
with the immediate injection site pain commonly seen after vaccination than a lasting effect of
the vaccine. See Tr. 729 (“I would not call [the red lump at the injection site] abnormal because
the phenomenon is often seen in clinical pediatric practice . . . some hours later a swollen red
area will develop at the injection site.”); Tr. 730-31 (“Q: Do you think the inconsolable crying . .
. [was] caused by the vaccine? A: I think it may very well have been. Q: And why is that? A:
Well, it certainly coincided with the period when the red tender lump appeared . . . so that would
fit that he was having discomfort.”).
48
See Tr. 623 (Dr. Niyazov). But, Dr. McGeady further countered this point by
saying that a red spot is not an abnormal response. Tr. 729, 752.
In short, the Sanchezes and their experts appear to place undue weight on
Trystan’s health on February 5-7, 2009. They seem to reason that because
inconsolable crying can be a manifestation of an encephalopathy or injury to the
nervous system, Trystan must have suffered a neurologic injury. See, e.g., Tr. 288;
Pet’rs’ Remand Br. at 44 (“Given this evidence and findings that fever and
inconsolable crying are symptoms and that they ‘could cause’ the vaccine injury . .
. then the logical conclusion is that fever, inconsolable crying and arm contortions
were evidence that the neurological system had been injured and were the first
onset symptoms of Trystan’s vaccine injury.”). But, Trystan’s health could be
entirely compatible with an expected response to the vaccination given in the
morning of February 5, 2009.
2. February 16-17, 2009
A primary, perhaps the primary, issue for which the Federal Circuit
remanded consideration was to address the significance, if any, of Trystan’s
behaviors February 16-17, 2009. As discussed below, Trystan’s behaviors
included an episode in which he contorted his arms. To address this issue, it is
necessary to cover: (a) the procedural activities regarding arm contortions that
have teed up this issue for consideration on remand, (b) the scope of the remand,
and (c) Trystan’s behaviors and health events occurring February 16-17, 2009,
including their significance to the causation analysis.
a) Procedural Background concerning Arm Contortions
(1) Activities before Remand
The question about arm contortions originated at the beginning of the case.
In Mr. Sanchez’s October 5, 2011 affidavit, he averred that on the evening of
February 16, 2009, 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.” Exhibit 4 ¶ 6. Dr. Steinman, in
turn, quoted this portion of Mr. Sanchez’s affidavit in opining in his first report
that “in the context of a febrile illness, [Trystan] may have had a seizure.” Exhibit
2 (Dr. Steinman’s Sep. 28, 2011 report) at 1. Later, Dr. Steinman added that
Trystan “suffered from seizures.” Id. at 2.
49
Ms. Sanchez averred that she communicated that Trystan had “weird
movements” and was “being very stiff” to Mr. Luna, the physician’s assistant.
Exhibit 3 ¶ 7. However, Mr. Luna’s record does not memorialize any complaint
about abnormal movements. See exhibit 1 at 48-51.
The discrepancy between the Sanchezes’ accounts and Mr. Luna’s record
prompted the undersigned to hold a hearing to determine whether preponderant
evidence supported a finding that Trystan, in fact, contorted his arms on the
evening of February 16, 2009. After hearing testimony from the Sanchez family,
the undersigned found that around February 17, 2009, “Trystan did not begin to
exhibit arm contortions.” Ruling Finding Facts, issued April 10, 2013, ¶ 11. The
Ruling directed the parties to provide the factual findings to the experts to ensure
that any expert presented opinions consistent with the factual findings. Id. at 16
(citing Burns v. Sec’y of Health & Human Servs.,
3 F.3d 415, 417 (Fed. Cir.
1993)).
After some missteps, Dr. Steinman eventually offered opinions that were
based upon factual assumptions consistent with the Ruling. See, e.g., exhibit 95.
With this foundation, the expert witnesses testified at the December 2017 hearing.
On direct examination, Dr. Steinman stated that the significance of arm contortions
is “contextual” and whether it and other symptoms indicate an encephalopathic
event can only be determined by employing an EEG. Tr. 257-58, 284-85.
However, Dr. Steinman did include Trystan’s arm contortions as part of what he
considers the “continuous process” of Trystan’s neurodegeneration. Tr. 298-99.
Dr. Niyazov testified that arm contortions could have been one of multiple
symptoms indicating “another . . . mitochondrial milestone or energy milestone in
that [Trystan] decreased – he achieved a new low in his energy.” Tr. 460.
However, Dr. Niyazov also testified that arm contortions could be seizure activity,
or “just behavioral problems that were created by the energy-starving brain.” Tr.
462-63.
However, with respect to arm contortions, the October 9, 2018 decision
deviated from the Ruling. This decision stated: Trystan’s “arms contorted and he
was jerking around.” Decision at 7, 2018 WL 5856556, at *4. From this premise,
the undersigned also found that Trystan’s “movements were of the type typically
displayed by an infant suffering from a cold.”
Id.
The deviation and associated reasoning were a primary ground for the
Sanchezes’ motion for review. The Sanchezes argued that in the undersigned’s
“new findings of fact, he places the arm contortions and jerking … as starting
50
February 15, 2009. However, [the special master] inappropriately adds his own
fact that the movements were the type typically displayed by infants suffering from
a cold. As previously discussed, no such evidence exists of interpreting medical
symptoms by the parents or by the experts for this conclusion and thus it is
arbitrary and capricious.” Pet’rs’ Mot. for Rev. at 29; accord id. at 4 n.5.
In response, the Secretary accepted the finding that Trystan’s arms
contorted. See Resp’t’s Resp. to Mot. for Rev. at 5 (citing both Ruling Finding
Facts and Decision).25 The Secretary defended the undersigned’s conclusion that
the “movements were of the type typically displayed by an infant suffering from a
cold.” See id. at 14-15.26
At the Federal Circuit, the parties repeated these arguments. The Federal
Circuit ruled that because the Decision found that Trystan contorted his arms
whereas the Ruling Finding Facts did not, the experts did not have an opportunity
to opine on the significance, if any, of the arm contortions. The Federal Circuit
rejected the Secretary’s argument that his experts had linked the arm contortions to
a cold. Thus, the Federal Circuit found it necessary to remand for further
consideration by the experts as to the bearing that Trystan’s arm contortions may
have on the causation analysis.
(2) Developments regarding Arm Contortions on
Remand
On remand, the parties were permitted to have their experts discuss the
significance of Trystan’s arm contortions. Order, issued June 12, 2020. Dr.
Steinman stated that “[a]lthough the Sanchezes described it as seizures . . . , the
arm contortions fall right into this definition [of dystonia].” Exhibit 185 at 2
(ellipses in original). Dr. Steinman also indicated that “[t]he arm contortions
(dystonia) are not a manifestation of the common cold. I searched various
websites on this matter and came up with no evidence whatsoever.” Id. at 3.
Dr.
Steinman added that “the fever and inconsolable crying were also evidence of the
25
In contrast, the Secretary asserted the undersigned committed a “harmless error” in
revising a different finding of fact regarding when Trystan began to manifest a loss of skills.
Resp’t’s Resp. to Mot. for Rev. at 5 n.7.
26
The heading to this section appears to contain a typographical error in that the heading
refers to Trystan’s behavior on April 15-16, 2009, when the correct dates are February 15-16,
2009.
51
onset of neurodegeneration along with Trystan’s arm contortions on February 16,
2009.” Id.
Dr. Raymond differed. Dr. Raymond opined that Trystan’s “discomfort and
irritability are consistent with a fever associated with a viral illness.” Exhibit P at
2. Dr. Raymond then directly addressed the arm contortions: “In terms of the
concerns that his arms were contorting, and he was jerking around, this is
consistent with an uncomfortable ill child who is tired and does not want to be
held.”
Id. Dr. Raymond further reasoned that “[i]f arm ‘contortions’ were the
onset of dystonia and Leigh syndrome due to basal ganglia injury, they would not
be transient and subside rapidly. They would be present when he saw the provider
Mr. Luna on February 17, 2009.”
Id. In response, Dr. Steinman re-asserted that
arm contortions are not a manifestation of the common cold and emphasized the
intermittent and progressive nature of dystonia across stages, citing information
from the National Institutes of Health. Exhibit 196 at 2.
During the remand hearing, the Secretary raised a new point. In cross-
examining Dr. Steinman, the Secretary elicited testimony that six-month-old
children lack the neurological development to move their arms behind their backs
voluntarily. Tr. 2054. Specifically, the process of myelination begins in the brain
and progresses down the body. This progress explains why infants cannot walk
until approximately 12 months old. Six-month-old children can typically pass a
toy from hand-to-hand in front of their body. They may also be able to prop
themselves if tipped from a seated position sideways. However, six-month-old
children cannot catch themselves when tipped from a seated position backwards.
Tr. 2120-24 (Dr. Raymond’s testimony).
While the undersigned closed the evidentiary record after the testimony, see
order issued July 10, 2020, the Sanchezes submitted new exhibits after the hearing,
claiming that Dr. Raymond’s “testimony was new and unexpected.” Pet’rs’
Remand Br. at 20. After a status conference held the day after the parties filed
their briefs, the Secretary decided not to challenge the admissibility of these newly
submitted articles. Resp’t’s Status Rep., filed July 31, 2020. Thus, exhibits 202-
206 are part of the record and the undersigned has considered them.
The Secretary’s position concerning the significance of the evidence
regarding myelination in six-month-old children is somewhat contradictory.
Initially, the Secretary commented that this evidence “is consistent with the Special
Master’s original fact finding that Trystan’s arm contortions began when he was
about a year old. 2013 Fact Ruling at 14.” Resp’t’s Remand Br. at 14. This
52
statement seemed to urge the undersigned to revise the fact-finding with respect to
existence or non-existence of arm contortions on February 16, 2009, again.
However, in reply, the Secretary “does not contest the Special Master’s finding
that Trystan’s ‘arms contorted’ on February 16, 2009.” Resp’t’s Reply on Remand
at 2.
Thus, it appears that there is no dispute that Trystan contorted his arms on
February 16, 2009. See Pet’rs’ Reply on Remand at 9-10. Given this finding, the
ensuing question is what is the significance, if any, of the arm contortions?
b) Scope of Remand
Before discussing the significance of arm contortions, the undersigned must
address the scope of the Federal Circuit’s remand. The Sanchezes may be arguing
that the Federal Circuit did not authorize a hearing on remand regarding the
significance of the arm contortions. Pet’rs’ Reply on Remand at 9.27
To the extent that the Sanchezes are arguing that the undersigned could not
receive evidence about the significance of arm contortions on remand, this
argument is not persuasive. With respect to the meaning of the arm contortions,
the Sanchezes’ case is analogous to E-Pass Techs., Inc. v. 3Com Corp., 473 F.3d
1213 (Fed. Cir. 2007), a case alleging infringement of a patent.
In E-Pass, the district court construed a term that appeared in the patent
“electronic multi-function card.” Based upon this claim construction, the district
court granted 3Com’s motion for summary judgment that its product did not
infringe the patent both literally and under the doctrine of equivalents. However,
on E-Pass’s appeal, the Federal Circuit corrected the claim construction and
remanded to the district court. E-Pass, 473 F.3d at 1216 (reciting procedural
history). On remand, the district court granted summary judgment again, ruling
that “even under a broader construction of ‘card,’ none of the accused devices
could infringe the ‘electronic multi-function card’ limitation.”
Id. at 1217.
On the second appeal, E-Pass argued that the district court’s grant of
summary judgment was inconsistent with the Federal Circuit’s opinion that
27
The Sanchezes’ remand brief is ambiguous in that the Sanchezes might be arguing that
the Federal Circuit did not allow reconsideration of the finding that Trystan’s arm contorted.
But, the remand brief could also be interpreted as arguing that the Federal Circuit did not allow
evidentiary development of the finding that the arm contortions were consistent with a cold.
53
“‘issues of material fact remain in dispute as to both literal and doctrine of
equivalents infringement under the proper construction’ of the term ‘card.’” Id. at
1218
(quoting the previous Federal Circuit opinion, E-Pass Techs., Inc. v. 3Com
Corp.,
343 F.3d 1364, 1365 (Fed. Cir. 2003)). However, the Federal Circuit
rejected this argument. The Federal Circuit reasoned that it “could not have
intended to foreclose a summary judgment of noninfringement because the record
did not yet contain the evidence that the parties would put forward in support of
their infringement and noninfringement contentions under the proper
construction.”
Id.
Thus, E-Pass teaches that when the Federal Circuit corrects an error of the
trial court, the parties may develop evidence before the trial court based upon the
corrected record. In E-Pass, the correction concerned claim construction. In the
present case, the change concerned the existence of arm contortions. Unlike in
Suel v. Sec’y of Health & Human Services,
192 F.3d 981 (Fed. Cir. 1999), cited in
the Sanchezes’ reply on remand, the appellate court in E-Pass remanded based on a
correction to a determination made by the lower court judge that underlay the
ultimate decision. The Federal Circuit in E-Pass thus did not order relitigation of a
critical fact, as prohibited by the law of the case doctrine emphasized in Suel, but
instead remanded for reconsideration of the ultimate decision in light of the
correction. Similarly, here, the Federal Circuit identified a discrepancy in the
undersigned’s conclusions regarding the existence of arm contortions between
findings of fact and the ultimate entitlement decision, and remanded for
reconsideration in light of the arm contortion evidence based on this discrepancy.
The Federal Circuit’s directions for remand dictate that the evidence of arm
contortions be properly considered as part of the causation analysis. Accordingly,
the undersigned may consider on remand how the arm contortions affect the
Sanchezes’ claim that the February 5, 2009 DTaP vaccination harmed Trystan.
c) Trystan’s Behaviors and Health on February
16-17, 2009
Trystan’s arm contortions were just one aspect of his behavior the evening
of February 16, 2009. On Ms. Sanchez’s birthday, February 15, 2009, Trystan had
run a fever again and was congested. Tr. 70-71. During this time, Ms. Sanchez
was pregnant with her third child and suffering from nausea and headaches. Id. at
181. On February 16, 2009, the night after Ms. Sanchez’s birthday, Trystan’s
fever became worse and, around midnight, Mr. Sanchez took a “really loud, high-
pitched” crying Trystan downstairs so that his wife could get sleep.
Id. at 71-72,
183. After Mr. Sanchez was able to calm Trystan, he would startle awake like he
54
could not breathe through his stuffy nose. Id. at 183-84.
One of those times, it
took Mr. Sanchez a bit longer to calm Trystan down and “he kept kicking his feet
and jerking around” in Mr. Sanchez’s arms, “almost as if he didn’t want to be
held.”
Id. at 184;
see also Ruling Finding Facts ¶ 8.
Mr. Sanchez took Trystan back upstairs around one or two o’clock in the
morning to tell his wife about Trystan’s apparent discomfort. Tr. 186. Trystan’s
temperature was 103.2 degrees. Tr. 72, 113. The Sanchezes did not take Trystan
to urgent care during the night, because after they gave him some more fever
reducer and another cool bath, he fell asleep. Id. at 73-74, 187-88; see also Ruling
Finding Facts ¶ 9.
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. at 49. 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;
see also
Ruling Finding Facts ¶ 10.
From these findings of fact, the experts analyze the various symptoms,
including Trystan’s high-pitched cry, fever, congestion, startling awake, jerking
around, and arm contortions, and draw different inferences from them. Dr.
Steinman opined, first, that Trystan had a seizure and, later, that Trystan
experienced dystonia. Both Dr. Steinman and Dr. Niyazov contend that Trystan
demonstrated an episode of neurodegeneration. Tr. 257, 289-90, 516, cited in
Pet’rs’ Remand Br. at 25. In contrast, in the December 2017 hearing, Dr.
Raymond maintained that these conditions (except for the arm contortions)
reflected a common cold. Tr. 830-31, 863-64.
There seems to be little reason to doubt that Trystan suffered from a
common cold or some type of upper respiratory infection. Babies often suffer
from colds during the winter and Trystan had older school-aged siblings who could
have transmitted a virus. Tr. 359, 732. Mr. Luna, the physician’s assistant who
examined Trystan, diagnosed him as suffering from congestion and a common
cold. Exhibit 1 at 48; see also Tr. 731-33 (Dr. McGeady’s testimony about Mr.
Luna’s diagnosis for Trystan). While Dr. Steinman and Dr. Niyazov, at times,
seemed to question the accuracy of the diagnosis of a common cold, see Tr. 413,
55
455; but see Tr. 2037, 2066, 2119, this skepticism over such a basic point tended to
reduce the credibility of Dr. Steinman and Dr. Niyazov. By all accounts, Trystan
recovered from the cold. Tr. 2042, 2066.
Trystan’s February 16, 2009 fever, in turn, derives from the infection. Tr.
772-74; see also Tr. 290 (Dr. Steinman: “a cold can cause fever”). Trystan’s
February 16, 2009 fever differs from the February 5, 2009 fever, which ebbed and
flowed for a “few days.” Ruling Finding Facts ¶ 7; see also id. ¶ 8 (On February
15, 2009, “Trystan had run a fever again”) (emphasis added). As Dr. McGeady
correctly interpreted the Ruling Finding Facts, Trystan’s February 5, 2009 fever
did not last through February 15, 2009. Tr. 731 (Dr. McGeady), 830 (Dr.
Raymond). Dr. Niyazov’s suggestion that Trystan suffered a continuous fever is
not in accord with the Ruling Finding Facts. See Tr. 455, 495. Even so, Dr.
Niyazov could not say that the February 5, 2009 vaccination caused the February
15, 2009 fever. Tr. 502.
Beyond the fever and congestion that are part of a common cold, Trystan
also cried, startled awake, jerked around in his father’s arms, and, most importantly
for this remand decision, contorted his arms. These behaviors are the foundations
for Dr. Steinman’s opinion that Trystan suffered a seizure or dystonia.
The changes in the inferences that Dr. Steinman drew from these behaviors
tend to diminish Dr. Steinman’s credibility. To review, Mr. Sanchez averred that
Trystan’s arms contorted on February 16, 2009. Exhibit 4 ¶ 6. Based upon Mr.
Sanchez’s affidavit, Dr. Steinman’s first report stated that Trystan “may have had a
seizure” and “suffered from seizures.” Exhibit 2 (Dr. Steinman’s Sept. 28, 2011
report) at 1-2.
As revealed during the December 2017 hearing, the confidence with which
Dr. Steinman opined that Trystan suffered a seizure based upon Mr. Sanchez’s
affidavit was overstated. Dr. Steinman recognized that only an
electroencephalogram (EEG) would allow a diagnosis of a seizure. Dr. Steinman
testified:
Kicking feet and jerking around. Is that evidence of a seizure?
Is it evidence of rebelliousness or discomfort? I don’t know. In
any particular feature like that that you hear about in a history
or observe, unless you had a video EEG with a set event,
kicking feet and jerking around, coupled to an
electroencephalogram, you couldn’t say for sure is that a
56
seizure, but kicking feet and jerking around could be an
encephalopathy.
Tr. 257. Later, Dr. Steinman elaborated on the usefulness of an EEG:
[I]f something is in doubt, if there’s a stiff arm or an abnormal
movement, we can hook an EEG up to a free-moving person
and see what’s happening, but in the absence of that, what is
making a lot of speculation on what is a seizure, what is a non-
seizure. And I can’t answer on any piece of history in the
literature that came from a parent or a nurse practitioner or a
doctor recording a history, what exactly was a seizure and what
exactly wasn’t a seizure.
Tr. 284-85. Dr. Steinman also described how even experts in epilepsy have
difficulty determining a seizure in the absence of an EEG. Dr. Steinman stated: “I
go to EEG report when I’m on duty and I see that happening by people who think
about epilepsy all day long and their blinded taste test, so to speak, without the
EEG shows we’re not very good at guessing.” Tr. 285. Dr. Steinman’s first report
in which he stated Trystan “may” have had a seizure and Trystan “suffered”
seizures did not disclose any limitations on the ability of a neurologist to identify a
seizure. Nevertheless, Dr. Steinman’s “educated opinion is that the seizure began
eleven days after the vaccination.” Tr. 288; accord Tr. 357.
After the weakness in his opinion regarding Trystan’s February 16, 2009
behavior as a seizure was brought out, Dr. Steinman shifted to say that a finding
that Trystan suffered a seizure was not necessary to his opinion. Tr. 292, 358. In
this context, Dr. Steinman offered the opinion that Trystan’s arm contortions were
dystonic posturing. Tr. 358. Given that the only source of information about
Trystan’s arm contortions on February 16, 2009, was Mr. Sanchez and this
information was equally available to Dr. Steinman when Dr. Steinman wrote his
first report, Dr. Steinman’s belated conclusion that the February 16, 2009 activities
were dystonic is surprising.28
28
The Secretary takes Dr. Steinman to task for failing to identify Trystan’s arm
contortions in his first five reports. Resp’t’s Remand Br. at 15-16. However, this criticism goes
too far because Dr. Steinman wrote four of those reports after the Ruling Finding Facts
(temporally) removed the arm contortions as a fact on which the experts could base their
57
Regardless of when Dr. Steinman came to the opinion that Trystan had
dystonia on February 16, 2009, Dr. Steinman’s current opinion is that Trystan had
dystonia and a seizure. See exhibit 196 at 3.29 Dr. Steinman’s opinion that Trystan
suffered a seizure on February 16, 2009, is not persuasive.
First, as discussed above, Dr. Steinman undercuts the ability of any
neurologist, even epileptologists, to identify a seizure without an EEG. In Dr.
Steinman’s words, “the batting average of their predictions isn’t that great.” Tr.
285.
Second, when Trystan eventually developed seizures, Trystan’s seizures
involved deviation of his head and eye, an altered consciousness, and a postictal
period. Exhibit 138 at 99 (Dr. Wong’s Dec. 7, 2010 report); see also exhibit P (Dr.
Raymond’s June 19, 2020 report) at 3 (citing this medical record), Resp’t’s
Remand Br. at 16 (citing Dr. Raymond’s report). This presentation seems too
different from the arm contortions on February 16, 2009, and too long after to find
a pattern of seizures.
Third, Dr. Raymond disagreed with Dr. Steinman. Exhibit P at 3. Dr.
Raymond wrote this report after remand for consideration of the arm contortions.
Thus, while Dr. Raymond’s testimony in the December 2017 hearing did not
account for arm contortions, see Tr. 830, his more recent opinion is based upon all
the facts.
Finally, at an August 7, 2012 appointment, one of Trystan’s treating
physicians, Dr. Haas, noted that Ms. Sanchez reported arm contortions following
the February 5, 2009 vaccination. Exhibit 26 at 1. However, while Dr. Haas noted
these arm contortions, this appointment occurred three years after the vaccination,
and Dr. Haas did not assess the arm contortions as indicative of a seizure or
neurological issues. Id. at 3.
The most Dr. Haas did was to memorialize Mr.
opinions. See Pet’rs’ Remand Br. at 24. On the other hand, the Sanchezes are too quick to
exonerate Dr. Steinman because they overlook his first report.
29
After the hearing, the Sanchezes introduced exhibits 202-05 to demonstrate that a
seizure can lead to dystonic posturing. The Sanchezes asserted that these articles were in
response to a question about the consistency of Dr. Steinman’s opinions. Pet’rs’ Remand Br. at
26. However, given that Dr. Steinman had already disclosed an opinion that Trystan suffered
both a seizure and dystonia on February 16, 2009 (exhibit 197), the Sanchezes appear to have
been capable of filing the exhibits in advance of the hearing.
58
Sanchez’s report that Trystan’s cousin “also had a dystonic reaction” to her one-
year-old vaccinations. Id. at 1.
For these reasons, the undersigned finds that the Sanchezes have not
established with preponderant evidence that Trystan suffered a seizure on February
16, 2009. With the elimination of a seizure, the next issue is whether Trystan
suffered dystonia.
Dystonia is “dyskinetic movements due to disordered tonicity of muscle.”
Dorland’s Illustrated Medical Dictionary 576 (32d ed. 2012). “Dyskinesia,” the
root for the term “dyskinetic” in that definition, means “distortion or impairment of
voluntary movement, as in tic, spasm, or myoclonus.” Id. at 572. Dr. Steinman
elaborated that dystonia is a neurologic problem ultimately manifesting in a
problem in posture. Tr. 2025. The source of dystonia is a problem in a part of the
brain known as the basal ganglia. Tr. 2025, 2157. 30 Dystonia can be a
manifestation of many neurologic disorders. Tr. 2026.
Dystonia can be a manifestation of Leigh’s syndrome. In one study of
Leigh’s syndrome, researchers investigated the background of 130 patients with
Leigh’s syndrome. After excluding patients with abnormal motor findings of
unknown onset, the group consisted of 57 patients. Of this group, 15 (or 26
percent) had dystonia at the onset of their Leigh’s syndrome with another 42 (or 74
percent of the 57 patients) developing dystonia later. Court exhibit 1003; accord
Tr. 2155-56 (Dr. Raymond acknowledging that although dystonia often starts later
in Leigh’s syndrome, dystonia can start earlier too). 31 As Dr. Steinman noted
“even though dystonia may be less frequent at onset, [dystonia] is still listed.”
Exhibit 185 at 2; accord Tr. 2157. The cumulative probability of having an onset
of Leigh’s syndrome with dystonia at six months is approximately five percent.
Kalliopi Sofou et al., A multicenter study on Leigh syndrome: disease course and
30
An MRI performed in December 2009 revealed that Trystan had a problem in his basal
ganglia. Exhibit 1 at 142, 130.
31
This Court exhibit comes from an article (Sofou) that Dr. Steinman cited. Exhibit 95
(Dr. Steinman’s Dec. 10, 2015 report) at 17-19; exhibit 185 (Dr. Steinman’s June 15, 2020
report) at 2-3. The Sanchezes filed Sofou as the article was published in written form as exhibit
97. The version of the Sofou article available on-line contains “additional files.” See exhibit 97
at 15. Of those additional files, the Court exhibit contains a relevant additional file, Table S2.
59
predictors of survival, 9 Orphanet J. Rare Diseases, at pdf 6, figure 3 (2014), filed
as exhibit 97; see also Tr. 2117-18.
In Dr. Raymond’s view, the progression of myelination affects the areas in
which dystonia can appear. Dystonia “typically is in those motor patterns that
[infants] have myelinated.” Tr. 2118. Dr. Raymond explained that a condition
called paroxysmal infant dystonia occurs in children a couple months to seven or
eight months old in which infants have abnormal “hand movements in front of
them.” Tr. 2118.
Dr. Steinman and Dr. Raymond disputed the degree to which myelination
permits or prevents six-month-old infants from manifesting dystonia by moving
their arms behind their backs. Although Dr. Steinman recognized that six-month-
old infants lack the ability to prevent themselves from falling backward when
pushed from a seated position, Dr. Steinman pointed out that myelination is a
developmental process. In his view, the myelination process “doesn’t mean that
there’s not enough myelin to transmit abnormal nerve impulses leading to
dystonia.” Tr. 2157-58. In contrast, Dr. Raymond stated that he “disagree[s] that
you can have that type of movement without appropriate myelination. So that
when we look at infantile dystonias, we are typically looking at – no, not typically,
we are always looking at movements that are following their usual repertoire in
that the basal ganglia is affecting that with an abnormality.” Tr. 2176-77.32
As an abstract question whether six-month-old infants are sufficiently
myelinated to experience dystonia by moving their arms backward is difficult to
answer on this case’s evidentiary record. 33 Dr. Steinman and Dr. Raymond are
both neurologists with decades of experience. Each has some experience with
pediatrics—Dr. Steinman holds a chair for pediatrics and Dr. Raymond held a
board certification in pediatrics from 1991-2005.34 Thus, each is qualified to offer
opinions. If the undersigned were forced to credit the opinion of one qualified
32
The transcript at 2176:13 and 2176:21 misidentified the speaker as Ms. Reynaud, the
attorney for the Secretary. The context indicates that Dr. Raymond spoke.
33
After the hearing, the Sanchezes submitted an article concerning the myelination of the
brain. Exhibit 206. However, this article does not help in determining the extent of myelination
in the peripheral nervous system, including the nerves that control the muscles for backward arm
movement.
34
However, as noted earlier in this decision, the Sanchezes did not seek to have Dr.
Steinman admitted as an expert in pediatrics.
60
expert and to reject the opinion of another qualified expert strictly based on
qualifications, the undersigned would be inclined to find Dr. Raymond more
qualified on this narrow point. Early in his career (1989-90), Dr. Raymond was a
fellow in “developmental neuropathology.” Exhibit M (curriculum vitae) at 1. Dr.
Steinman’s fellowship was in chemical immunology. Exhibit 168 (curriculum
vitae) at 1. This difference in advanced specialization would break any tie in Dr.
Raymond’s favor.
On the more specific question as to whether Trystan experienced dystonia on
February 16, 2009, the evidence is firmer that he did not. Both experts agree that
dystonia originates in the basal ganglia. Tr. 2025, 2157. Before the hearing Dr.
Raymond had written: “If Trystan were having arm contortions in February 2009
due to Leigh syndrome and basal ganglia injury, they would have been persistent
and obvious and it is expected that his attentive parents would have brought it to
the attention of his providers as they did for his other illnesses.” Exhibit P at 2-3.
Dr. Raymond’s testimony was similar. He maintained that “[i]f we look at basal
ganglia injury for whatever reason, it typically – it typically presents initially with
hypotonia, and it only much later presents with dystonia.” Tr. 2177. Although
given an opportunity to address this sequence, the Sanchezes did not present any
contrary testimony. Tr. 2177.
Further, it seems unlikely that Trystan would experience an episode of
dystonia that is caused by an injury in his basal ganglia one time in February 2009
and not experience any other motor problems for months. Cf. O’Connell v. Sec’y
of Health & Human Servs., No. 96-63V, 1998 WL 64185, at *12 (Fed. Cl. Spec.
Mstr. Feb. 2, 1998) (deeming “arm jerking” immediately post-vaccination as not
indicating the onset of neurological issues in part because of the lack of medical
attention and follow-up, even where seizure activity developed weeks later), mot.
for rev. denied,
40 Fed. Cl. 891 (1998), aff’d in unpublished op.,
217 F.3d 857
(Fed. Cir. 1999); Lara v. Sec’y of Health & Human Servs., No. 90-1655V,
1993
WL 215068 (Fed. Cl. June 4, 1993) (a child having eye fluttering five to six times
per days several days a week as well as “whole body jerks” from age two-months
to four-months was found to have seizures before receiving a vaccination at age
four-months). While Dr. Steinman states that “the dynamic effect of the shot was
to create damage in the nervous system,” Tr. 295, and that dystonia can be
“intermittent,” see exhibit 196 (Dr. Steinman’s June 22, 2020 report) at 2; Tr.
2029, Dr. Steinman could not specify how frequently even “intermittent” dystonia
appears. Tr. 2029. Dr. Steinman’s opinion suggesting that Trystan could have
dystonia in February but not again for many months is not persuasive.
61
Therefore, the undersigned finds that the Sanchezes have not shown by
preponderant evidence that Trystan’s February 16, 2009 arm contortions were a
manifestation of a seizure or an episode of dystonia. For the reasons explained
above, the February 16, 2009 arm contortions do not constitute a neurologic
abnormality caused by his vaccination. Because the Sanchezes bear the burden to
establish the onset of Trystan’s neurologic injury caused by the vaccination and
because they have not met this burden, the analysis of the arm contortions can end
here.
If more about the arm contortions is needed, then Dr. Raymond’s opinion is
credible. Dr. Raymond stated, “In terms of the concerns that his arms were
contorting, and he was jerking around, this is consistent with an uncomfortable ill
child who is tired and does not want to be held.” Exhibit P at 2. Dr. Raymond’s
post-remand supplemental opinion, which includes arm contortion, is in accord
with his December 2017 testimony. Tr. 863, 874.
Dr. Steinman stated that “‘arm contortions,’ known as dystonic posturing,
are not associated with the common cold.” Exhibit 185 at 2; see also Tr. 460-61,
462-63, 516 (Dr. Niyazov testifying that Trystan’s arm contortions likely
constituted neurodegenerative events). However, the undersigned has found that
Trystan’s February 16, 2009 arm contortions are not a manifestation of dystonic
posturing. Although arm contortions could be a neurologic finding, Tr. 2142, they
do not have to be. For Trystan, in February 2009, the arm contortions were not a
manifestation of a neurologic injury.
3. End of February to beginning of April 2009
The next period of Trystan’s life, from the resolution of his cold near the end
of February through the beginning of April 2009, strongly influences the outcome
of the Sanchezes’ claim for compensation. As noted above, the Sanchezes argue
that the vaccination altered Trystan’s development. In the words of their primary
expert, Dr. Steinman, in February 2009, Trystan took a “big hit.” Tr. 2042.
However, as reviewed in this section, evidence of this alleged “big hit” does not
appear in the ensuing weeks.
Between the February 17, 2009 appointment with Mr. Luna and the April
29, 2009 appointment with Dr. Seleem, Trystan did not see any medical providers.
As detailed in paragraphs 12-13 of the Ruling Finding Facts,
12. Sometime [after February 17, 2009], Trystan’s extended
family gathered to watch a boxing match. Tr. at 25, 219.
62
During this gathering, Trystan was sick, crying, fussy, and
congested. Id. at 191. He was not contorting his arms nor was
he limp or rigid.
13. Between [Ms. Sanchez]’s birthday and the next time she
took him to the doctor nearly two months later in late April,
Trystan suffered from cough and congestion episodically.
Exhibit 1 at 50. During this time, he did not lose control of his
head and trunk, nor did he stop making eye contact or stop
wanting to play anymore. He did not exhibit arm contortions.
Ruling Finding Facts at 13, ¶¶ 12-13. The October 9, 2018 decision similarly
stated that “[b]etween the February 17, 2009 visit with Mr. Luna and the April 29,
2009 visit with Dr. Seleem, Trystan did not have any symptoms that were
inconsistent with a cold.” Decision at 8, 2018 WL 5856556, at *4. These facts are
not contested.35
Neither Dr. Steinman nor Dr. Niyazov can identify any behavior in Trystan
that shows evidence of neurodegeneration or neurologic problem between the
February 16, 2009 cold and Trystan’s loss of skills. Dr. Niyazov was asked about
evidence that Trystan had neurodegenerative events between February 5 th and June
1st. Dr. Niyazov responded: “Inconsolable crying, loud high-pitched crying,
kicking feet and jerking around, contorting arms, and then no walking, standing --
well that’s six months.” Tr. 516. Significantly, Dr. Niyazov has identified
behaviors that happened on February 16, 2009: “Inconsolable crying, loud high-
pitched crying, kicking feet and jerking around, contorting arms.” He did not
identify another behavior in the relevant time as Trystan would not be expected to
walk until around his first birthday. Ms. Marin-Tucker noted a delay in Trystan’s
ability to walk; however, this was at Trystan’s May 2009 appointment, months
later. Exhibit 1 at 54 (“[can] not walk or stand, extremities seem soft yet rigid at
times, rolls a little, head lag, no crawling”).
In lieu of any factual findings that Trystan displayed any abnormal
behaviors, Dr. Steinman and Dr. Niyazov attempt to excuse the lack of findings.
To some extent, as the October 9, 2018 decision recognized, parents may not
35
In their motion for review, the Sanchezes argued that the submission of Ms. Sanchez’s
day planner should have altered the findings of fact. Pet’rs’ Mot. for Rev. at 3. However, the
Court of Federal Claims rejected that argument. Opinion and Order at 250-51. The Sanchezes
did not further pursue this argument to the Federal Circuit.
63
notice that their child is failing to meet milestones or conceivably, parents may not
notice that their child is losing skills he once had. Decision at 27, 2018 WL
5856556, at *16; see also Tr. 313 (Dr. Steinman commenting on observations).
However, according to Dr. Raymond, a child with damaged basal ganglia is likely
to have low tone and maybe abnormalities in eye movement or breathing issues.
Tr. 2127. However, there is no persuasive evidence of abnormal eye movements
or hypotonia from the end of February for many weeks.
Alternatively, the Sanchezes maintain that Trystan experienced a “fade”
response as described in the Naviaux commentary to the Shoffner article. See
Pet’rs’ Remand Br. at 51-53. For this argument, the Sanchezes primarily rely upon
Dr. Niyazov’s testimony, although Dr. Steinman similarly suggested that the
progression of Trystan’s condition might stop and stutter. Tr. 298.
Preliminarily, the value of the Naviaux commentary is uncertain. The
account that Dr. Niyazov presented came from a blog of the website for the group
Autism Speaks. See exhibit 68 (Dr. Niyazov’s report) at 13 (bibliography); Bob
Naviaux, Commentary on Fever Plus Mitochondrial Disease Could Be Risk
Factors for Autistic Regression by Shoffner et al., filed as exhibit 80. Dr. Niyazov
did not know whether the Naviaux commentary was peer-reviewed. Tr. 526.
While the lack of peer review could diminish the value of opinions expressed, Dr.
Niyazov vouched for Dr. Naviaux’s credentials, describing Dr. Naviaux as a “very
trusted and respected person, an expert in the field of mitochondrial disease.” Tr.
526. A second issue is that the underlying Shoffner article and Naviaux
commentary are written about children with autism, which is not Trystan’s disease.
See Tr. 310, 833-34; see also H.L. v. Sec’y of Health & Human Servs., No. 10-
0197V, 2016 WL 3751848, at *17 (Fed. Cl. Spec. Mstr. Mar. 17, 2016)
(petitioner’s witness “admitted that she is not aware of any reliable study
attributing acute metabolic decompensation to a flu vaccine among patients with
Leigh Disease”), mot. for rev. denied,
129 Fed. Cl. 165 (2016), aff’d, 715 F. App’x
990 (Fed. Cir. 2017). But, this issue, too, can be set aside to address the substance
of the argument that Trystan faded.
Dr. Naviaux stated “[w]hen children with the common forms of
mitochondrial disease suffer a regression, it is most often a ‘fade’ response. The
fade response is typically delayed for 2-10 days after a fever resolves.” Exhibit 80
(Naviaux) at 2 (underline in original). Based upon reports from parents, Dr.
Naviaux describes the fade response: “the child was getting better from their cold
or flu, when suddenly, their consciousness fades. The child can become difficult to
fully awaken, or will stop walking, stop talking, stiffen or lose muscle tone, or
have a seizure, or a stroke-like episode.” Id. The Sanchezes state in multiple
64
places that Trystan suffered a fade response. See, e.g., Pet’rs’ Remand Br. at 37,
52. The Sanchezes rightfully point out that Trystan had not yet developed the
ability to walk or to talk.
However, there is not preponderant evidence that Trystan experienced a fade
as Dr. Naviaux has described. There is no evidence that in the months after his
February 5, 2009 vaccination, Trystan began to lose consciousness or was difficult
to awaken. In contrast, the Ruling Finding Facts found that Trystan continued to
play. Similarly, there appears to be no evidence that between February 17, 2009,
and at least May 1, 2009, that Trystan suffered a seizure or stroke-like episode.
Trystan did have arm contortions on February 16, 2009. But, that episode was
short-lived, singular, and did not signify a neurologic injury due to vaccination.
The Ruling Finding Facts found that during a boxing match the family watched
after February 17, 2009, Trystan was neither limp nor rigid. Therefore, the
argument that Trystan is like the children reported in the Naviaux commentary
advanced by Dr. Niyazov is inapt.
So, too, are comparisons between Trystan and Karl Paluck. By way of
review, approximately 2-3 weeks after vaccination, Karl experienced such
worsened stiffness in his limbs that his parents took him to a chiropractor for
several visits. Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1376
(Fed. Cir. 2015). In the ensuing months, Karl’s pediatric neurologist noted that
Karl suffered from “gross motor delay, global developmental delay, and
hypertonicity.”
Id. A later MRI confirmed a thinning of the corporal collosum.
Id. Karl suffered seizures and was later diagnosed with an unspecified
mitochondrial disorder.
Id. Trystan did not manifest a progression of stiffness in
his limbs for which his parents sought medical attention.
While the Sanchezes have also compared Trystan to Hannah Poling, that
analogy does not hold true. Dr. Naviaux pointed to Hannah Poling as an example
of the “flare” response. As weak as the evidence that Trystan suffered a fade is,
any claim that Trystan suffered a flare is even weaker. Dr. Naviaux describes a
flare as “occur[ing] early, at the peak of the fever and inflammatory response,
within 2-3 days of infection. During a flare response, there is a high fever, often
over 102⸰F, and hyperirritability, crying, inconsolability, a disrupted sleep-wake
cycle, and a refusal to walk in children who might otherwise appear physically able
to walk.” Exhibit 80 (Naviaux) at 2 (underline in original). “Following a flare
response, there can be a gradual evolution of other problems from persistent GI
problems and diarrhea, a gradual loss of language over 2-3 months, with the onset
of repetitive movements, to gaze avoidance and social avoidance. It must be
emphasized that a flare response is not simply a high fever, or even a dramatic
65
reaction to a high fever, like a febrile seizure.” Id. Except for inconsolable crying
and fever, Trystan did not have problems such as a disrupted sleep-wake cycle,
gastrointestinal problems, or social avoidance.
In sum, Trystan did not present like any of the children to whom the
Sanchezes have compared him.36 The undersigned recognizes that Trystan does
not have to match any of these prior cases. On the other hand, the prior cases do
start to form a tentative pattern in which children who may have been harmed by a
vaccination show evidence of decline within a few weeks of the vaccination. The
evidence of decline might “ebb and flow.” Tr. 460. But, even a progression that
ebbs and flows has some periods in which the child displays some worsening
symptoms. Here, Trystan did not.
Implications for Althen Prong 3
As discussed earlier, Althen prong 3 requires (a) persuasive evidence about
the timeframe between a vaccination and the onset of a problem for which
inferring causation is appropriate and (b) persuasive evidence that the onset
occurred in that time. The undersigned has found that the evidence tends to
suggest that the expected interval is around two weeks, although this period cannot
be rigidly defined.
Within two weeks, Trystan did experience two episodes. First, on the day
and night of vaccination, he experienced a fever, inconsolable crying, and a mark
on his leg. Second, approximately 11 days later, Trystan had a common cold. In
association with this cold, Trystan experienced a fever, congestion, restlessness,
jerking around, and arm contortions. Taken in isolation, each seems to be a
relatively benign, if not typical, part of infancy.
However, as Dr. Steinman stated, context matters. Tr. 257, 265, 325, 2019,
2057. If, in the following weeks and months, Trystan had displayed neurologic
problems, such as spasticity for which his parents sought treatment like Karl
Paluck or the consistent eye blinking of Ashlyn Markovich, then the relatively
benign episodes could be viewed in context as more significant. But, Trystan did
not display any behaviors that suggested any neurologic problems from February
17, 2009, to at least May 1, 2009, well beyond the approximate two-week onset of
36
In the context of genetics, Dr. Niyazov accused Dr. Raymond of “cherry-picking”
cases that support Dr. Raymond’s opinion. Tr. 2162. But, the comparisons offered in the text
are comparisons from cases and articles that the Sanchezes have offered.
66
symptoms anticipated by the Sanchezes’ medical theory. Consequently, the
Sanchezes have failed to meet their burden of proof regarding prong 3.37
4. April to May 2009
As previously described, from the end of February through approximately
mid-April, Trystan experienced relatively good health. He did have episodes of
coughing and congestion occasionally. Ruling Findings Fact, issued April 10,
2013, ¶ 13.
On April 29, 2009, when pediatrician Dr. Nabil R. Seleem saw
Trystan, then eight and a half months old, he noted that Trystan
had suffered cough and congestion for two weeks. No unusual
arm movements or developmental issues were reported. In his
neurological review, Dr. Seleem noted “[n]o neurological
symptoms.” Ultimately, he diagnosed Trystan with an ear
infection and bronchitis and prescribed amoxicillin. Exhibit 1
at 50-52.
Ruling Finding Facts ¶ 14. Additionally,
Dr. Seleem did not observe any signs consistent with a
neurological injury during the examination performed on
Trystan during the April 29, 2009 visit. Instead, Trystan had a
cold.
Decision at 8, 2018 WL 5856556, at *4.
Trystan’s mother and grandmother brought Trystan back to the
clinic to see Dr. Brown on May 13, 2009. Dr. Brown observed
that Trystan’s infection appeared to be resolving, and
recommended continued use of a humidifier. No reports of the
loss of eye contact or an inability to roll over were made at this
time. Exhibit 1 at 53.
Ruling Finding Facts ¶ 15.
37
To be clear, in determining that the Sanchezes have not met their burden regarding
prong 3, the undersigned has not considered the effect of the colds for which Trystan was treated
on April 29, 2009, and May 13, 2009.
67
As noted in the October 9, 2018 decision, Dr. Steinman and Dr. Niyazov
largely ignored the visits with Dr. Seleem and Dr. Brown. This oversight is most
readily apparent in demonstrative exhibits used during Dr. Steinman’s and Dr.
Niyazov’s testimony. See exhibits 162 and 165; see also Tr. 338-39 (Dr.
Steinman’s testimony in reference to exhibit 162), 458-59 (Dr. Niyazov’s
testimony in reference to his timeline). Both demonstrative exhibits omit a
summary of these visits on their timelines.
Other examples of Dr. Steinman and Dr. Niyazov skipping over the visits for
colds appear as well. Dr. Niyazov testified: “We can only follow February 5th and
16th and August 8th and June 1st.” Tr. 462. This list does not include observations
from Dr. Seleem and Dr. Brown.
In the hearing on remand, when asked for the next data point along Trystan’s
“downward cascade” following the February 16-17, 2009 episode, Dr. Steinman
pointed to the second set of vaccinations, which occurred in August 2009. Tr.
2035-36. Similarly, early in Dr. Steinman’s testimony during December 2017, he
described Trystan as a “healthy well child and following that February 5th
immunization and then even more dramatically after the August -- mid August 2nd
encounter that we call response, he had neurologic deterioration.” Tr. 292.
Similarly, Dr. Steinman stated: “there’s no doubt it began February 5th, it
worsened in mid August.” Tr. 293.
A question from the Sanchezes’ attorney also shows how Dr. Steinman
minimized the illnesses:
Q: If Trystan had a couple colds between February 16 and June
1, would that impact your opinion regarding this continuous
process?
A: No. I mean, children in the winter are going to get
respiratory infections, so it’s the unusual child who would not
have that.
Tr. 298. The question is posed as a hypothetical but there is no dispute that
Trystan had colds in the relevant time.
Dr. Steinman’s dismissal of the sicknesses is inconsistent with his later
testimony that “infections . . . can devastate or kill” children with mitochondrial
diseases. Tr. 312; accord Tr. 2044. Later, in response to a question from the
undersigned, Dr. Steinman recognized that infections could contribute to Trystan’s
68
Leigh’s syndrome but the infections did not because Trystan did not have a fever.
Tr. 360-61. Dr. Steinman repeated this opinion in the remand hearing in which he
stated that “small” colds would not affect Trystan. Tr. 2043-44.
Dr. Niyazov also admitted that “if anything comes in in the meantime
[referring to the period between February 16, 2009, and the loss of skills on June 1,
2009] and hits the child’s system again, like a fever of 103, . . . then that will
contribute to that fade response.” Tr. 459; accord Tr. 2076. Dr. Niyazov did make
some attempt to fit the colds into his overall theory of the case by stressing
Trystan’s vulnerability, as evidenced by the following exchange during the original
entitlement hearing:
Q: Now, if there were some other illnesses between February
16th and June 1st, what impact would those have on Trystan
who’s now more susceptible and his energy levels are ebbing
and flowing, if I’m hearing that correctly?
A: Right. So there will be -- it will have a detrimental effect
and it will decrease the energy further and, at some point, he
would start losing skills.
Tr. 460; accord Tr. 2076.
The undersigned recognizes that in Dr. Steinman’s and Dr. Niyazov’s view,
Trystan started a decline on February 5, 2009. Thus, they could reasonably assert
that the colds in April and May only contributed to an on-going process. The flaw,
however, is that, for the reasons explained at length above, the Sanchezes have not
presented persuasive evidence that Trystan’s decline started on February 5, 2009.
See Tr. 2124 (Dr. Raymond).
Instead, if Trystan did not start a neurologic decline until May 1, 2009, at the
earliest—as the October 9, 2018 decision finds and this decision confirms—then
the analysis proceeds differently. If it is assumed for the sake of argument that a
trigger, such as an upper respiratory infection, could influence the outcome of a
child with Trystan’s genetic mutations, then the infection is a more likely trigger
for the neurologic decline. The sequence of events fits much better. On April 29,
2009, Ms. Sanchez reported that Trystan had been ill for two weeks. Exhibit 1 at
50-52. Then, Trystan started to lose developmental skills perhaps as early as May
1, 2009, which would be approximately two weeks after he became infected. At
the August 17, 2009 primary care visit, Ms. Marin-Tucker noted certain
developmental delays and loss of skills that Ms. Sanchez reported began occurring
69
“2-3 months ago” (i.e., around May 17, 2009, or June 17, 2009). Id. at 54. This
loss of skills included “[can] not walk or stand, extremities seem soft yet rigid at
times, rolls a little, head lag, no crawling, . . . can [not] sit or grasp.”
Id. Ms.
Marin-Tucker also noted “speech and language deficits” and “developmental
delays.”
Id.
As discussed in the context of prong 3, Edmonds and Shoffner suggest that
an appropriate interval to infer causation is approximately two weeks between the
inciting event and the onset of decline. Edmonds and Shoffner, therefore, align
with an account that Trystan’s neurodegeneration began around May 1, 2009. But,
to repeat, the foregoing analysis assumes that a trigger is needed. Thus, assuming
this medical theory and, in light of Trystan’s May 2009 onset of
neurodegeneration, it is more likely that Trystan’s infections between February and
May 2009 caused the manifestation of his Leigh’s syndrome, independent of his
vaccinations.
5. August 2009
The following facts were established in the Ruling Findings Fact:
19. At [Ms. Sanchez]’s baby shower, on August 8, 2009,
Trystan exhibited inconsolable crying. Tr. 25, 45-46, 88-89,
137, 159. At times, instead of being rigid, his body was limp,
as if he had no muscle tone. Id. at 46, 53. At other times
during this day, he was contorting his arm. Id. at 89, 137, 160.
20. At one year old, Trystan was seen by Physician Assistant
Micaela Marin-Tucker for a well-child exam. Exhibit 1 at 54-
56; Tr. 89-90. Ms. Sanchez informed Ms. Marin-Tucker that
she “noticed a change in [Trystan’s] development about 2-3
months ago38 but since she had taken [Trystan to the pediatric
clinic] with Dr. Brown she thought that everything was ok.”39
38
According to this report, Trystan’s developmental changes began between May 17,
2009, and June 17, 2009.
39
Ms. Sanchez testified that she had reported to Ms. Marin-Tucker that Trystan’s
developmental changes began five to six months before his August 17, 2009 visit, which would
be between February 17, 2009, and March 17, 2009. Tr. 90-91. Ms. Sanchez’s August 17, 2009
recounting of the onset of Trystan’s developmental delays is more reliable than testimony
offered more than two years after his visit to Ms. Marin-Tucker. Testimony offered so long after
70
Exhibit 1 at 54. (This history is the basis for the conclusion in
paragraph 18 that Trystan’s loss of skills began around June 1,
2009.) Upon a review of systems, Ms. Marin-Tucker found that
Trystan did not walk, stand, crawl, and hold his head up while
sitting, or make any attempt to move his lower extremities. She
also noted in her examination that his extremities seemed soft,
yet rigid at times. As the result of her examination, Ms. Marin-
Tucker ordered a battery of lab tests. Exhibit 1 at 54-55. She
also referred Trystan to a neurologist, physical therapist, and
occupational therapist. Id. at 55; Tr. 90. Additionally, Trystan
received his third hepatitis B vaccine, as well as his second
doses of the pneumococcal conjugate, DTaP, and Hib vaccines.
Exhibit 1 at 55; Tr. 92. Trystan was to return to the nurse the
next week to receive the remaining vaccinations that were due,
including the measles, mumps, and rubella, varicella, and
hepatitis A vaccines. Exhibit 1 at 55.
Ruling Findings Facts ¶¶ 19-20.
Before considering how Trystan fared after his second set of vaccinations,
Trystan’s developmental status on the day he received his second set of
vaccinations should be established. Some information about Trystan’s health
before the second set of vaccinations comes from his family’s testimony about his
behavior during the baby shower on August 9, 2009.
This testimony credibly established that Trystan lacked muscle tone and was
having arm contortions. Trystan’s behavior appears to fit how Dr. Raymond
asserted that problems originating in the basal ganglia would present: first with
hypotonia and later with dystonia. See Tr. 2177. Furthermore, a decline starting in
May or June through August 17, 2009, would be consistent with Dr. Naviaux’s
fade response. Tr. 833 (Dr. Raymond).
Otherwise, the experts did not focus too much on Trystan’s developmental
status just before August 17, 2009. Dr. Steinman recognized that by the date of
Ms. Marin-Tucker’s examination, Trystan’s loss of skills had been going on for
some time. Tr. 296-97; see also Tr. 2124 (Dr. Raymond). Rather, Trystan’s status
the events in question is less reliable than reports provided closer in time, when the motivation
for accurate explication of symptoms is more immediate.
71
on the day of his second set of vaccinations forms a foundation for the argument
that Trystan experienced a rechallenge.
6. October – December 2009, including Rechallenge
Information about Trystan’s development following his August 17, 2009
vaccinations is scarce. The Ruling Findings Facts stated:
21. About six weeks [after the August 17, 2009 vaccination], on
October 7, 2009, both Jennifer and Germain went to see Ms.
Marin-Tucker for a follow-up. In a review of Trystan’s
systems, Ms. Marin-Tucker noted no seizures, weakness, or
tics. She made no notation of tremors or twitching. Upon
neurologic examination, she found Trystan to be unable to
grasp, sit, crawl, or make much eye contact. Germain reported
that there was “another child in the family with the same
symptoms and doctors [could] find nothing wrong.” Ms.
Marin-Tucker emphasized the importance of making the
appointment with a neurologist as soon as possible. Exhibit 1
at 57-58.
Ruling Finding Facts ¶ 21. This statement also appears in the October 9, 2018
decision.
Based upon Ms. Marin-Tucker’s notes from two appointments, Dr. Steinman
characterized this “as a worsening of [Trystan’s] neurologic condition” after his
second vaccinations. Tr. 336. This conclusion is reasonable. However, the
ensuing question is whether the Sanchezes have established that the challenge-
rechallenge paradigm fits this case.
Evidence of challenge-rechallenge can be powerful evidence in support of a
claim that a vaccine harmed an individual. See Koehn v. Sec’y of Health &
Human Servs., No. 11-355V, 2013 WL 3214877, at *30 (Fed. Cl. Spec. Mstr. May
30, 2013), mot. for rev. denied,
113 Fed. Cl. 757 (2013), aff’d,
773 F.3d 1239
(Fed. Cir. 2014). “A rechallenge event occurs when a patient who had an adverse
reaction to a vaccine suffers worsened symptoms after an additional injection of
the vaccine.” Capizzano v. Sec’y of Health & Human Servs.,
440 F.3d 1317, 1322
(Fed. Cir. 2006). To this basic definition, Dr. Raymond added that “[t]he
challenge should meet the criteria of same latency and same effects, and must
exclude well-accepted alternative explanations.” Exhibit P at 4.
72
The Sanchezes criticize Dr. Raymond for not adopting the “legal definition”
of rechallenge. Pet’rs’ Remand Br. at 38 n.15. However, to the extent that Dr.
Raymond is promoting the idea that the challenge and the rechallenge events
should be similar or the same, this concept has appeared in other cases from a
variety of sources. See, e.g., R.V. v. Sec’y of Health & Human Servs., No. 08-
504V, 2016 WL 3882519, at *19 n.62 (Fed. Cl. Spec. Mstr. Feb. 19, 2016) (relying
upon Dr. Shafrir), mot. for rev. denied,
127 Fed. Cl. 136 (2016), app. dismissed,
Fed. Cir. 16-2400 (Oct. 26, 2016); Tompkins v. Sec’y of Health & Human Servs.,
No. 10-261V,
2013 WL 3498652, at *27 n.68 (Fed. Cl. Spec. Mstr. June 21, 2013)
(citing report from Institute of Medicine), mot. for rev. denied,
117 Fed. Cl. 713
(2014); Freeman v. Sec’y of Health & Human Servs., No. 04-1528V,
2009 WL
5103594, at *12 (Fed. Cl. Spec. Mstr. Dec. 9, 2009) (relying upon opinion of Dr.
Sundel and report from Institute of Medicine); Tosches v. Sec’y of Health &
Human Servs., No. 06-192V,
2008 WL 440285, at *7 (Fed. Cl. Spec. Mstr. Jan. 31,
2008) (relying upon testimony of Dr. McCusker); Stevens v. Sec’y of Health &
Human Servs., No. 99-594V,
2006 WL 659525, at *14 (Fed. Cl. Spec. Mstr. Feb.
24, 2006) (testimony of Prof. Dunbar). The relative resemblance of the two events
would seem to contribute to the strength of the challenge-rechallenge paradigm.
For example, if a person developed a rash one week after receiving one vaccine
and if the person had a seizure one week after receiving the second dose of this
vaccine, the rash and seizure might have different etiologies.
Dwelling on the nuanced points of challenge-rechallenge seems unnecessary
in this case. The Sanchezes have not established the challenge aspect. As
explained above, the Sanchezes have not presented preponderant evidence that
Trystan suffered any neurologic problem within at least one month of the February
5, 2009 vaccine. And, by simple definition, without a “challenge,” there can be no
“rechallenge.”
Moreover, to the extent that similarity in reaction can be considered in an
analysis of challenge-rechallenge, the Sanchezes’ argument weakens even further.
The Sanchezes have alleged that following the first DTaP vaccination, Trystan
reacted acutely by crying inconsolably, running a fever, and developing a red spot
on his thigh. But, there appears to be no persuasive evidence that Trystan suffered
any type of acute reaction to the second DTaP vaccination. The Sanchezes have
not offered any explanation for why an agent that produced (in their view) a sharp
response on Trystan’s first encounter would produce a much different response on
the second encounter.
73
In advancing their challenge-rechallenge argument, the Sanchezes have cited
reports from doctors who obtained histories about Trystan much later. See Pet’rs’
Remand Br. at 32-33 (citing exhibit 1 at 196 (Dr. Friedman’s August 2, 2010
report) and exhibit 26 at 8 (Dr. Haas’s March 26, 2013 report)). A more detailed
analysis of the reports from some treating doctors, including Dr. Friedman and Dr.
Haas, is deferred until section VII.C below. However, the undersigned has
considered Dr. Friedman’s and Dr. Haas’s statements in finding that the Sanchezes
have not met their burden of proof with respect to challenge-rechallenge.
Although Ms. Marin-Tucker observed that Trystan lost developmental abilities in
her appointment on October 7, 2009, that decline does not automatically constitute
a rechallenge.
The Ruling Finding Facts memorializes the next events in Trystan’s history.
It states:
22. Between October 7, 2009, and his neurology visit on
November 12, 2009, Trystan began having “tremors” or
“twitching” of his whole body. Tr. at 199-200; Exhibit 1 at
140.
23. On November 12, 2009, Trystan was taken to see Dr. David
J. Michelson, the neurologist to whom he was referred. Dr.
Michelson recorded reports that Trystan was unable to sit
independently, his hands stayed closed, and his feet went
forward when at rest. He noted that, at times, Trystan could
hold his mouth open tightly and drool, but at other times he
could chew and swallow well. While Trystan had previously
held his right arm stiffly behind him episodically, he had not
done this lately. Dr. Michelson’s review of systems was
positive for muscle spasms, global developmental delay,
weakness, walking problems, constipation and birthmarks.
Dr. Michelson noted that Trystan suffered from “global
developmental delay of unclear etiology, though a genetic
predisposition is suspected based on the family history and a
[central nervous system] cause is suggested by the physical
exam findings.” Exhibit 1 at 140-41.
Ruling Finding Facts ¶¶ 22-23. Dr. Michelson ordered an MRI, which Trystan
underwent in December 2009. The MRI showed problems in Trystan’s basal
ganglia. Exhibit 1 at 142; see also id. at 130 (reinterpretation of same study). A
74
problem in the basal ganglia is often found in people suffering from Leigh’s
syndrome. See Tr. 407, 2126.
The doctors spent several years trying to determine what condition was
afflicting him. Finally, during this litigation, the Sanchezes obtained genetic
testing for Trystan. Exhibits 53 and 59. These tests showed that Trystan suffered
two mutations. Whether these mutations caused Trystan’s Leigh’s syndrome is
discussed in section VIII below.
In sum, this section B has considered both how the Sanchezes’ experts
predicted an adverse reaction to the vaccination would appear and how Trystan
actually appeared. Because of the dichotomy between the predicted and the actual,
the sequence of events is not logical. Thus, the Sanchezes have not met their
burden regarding prong 2.
C. Treating Doctors
With respect to Althen prong 2, the Federal Circuit has instructed special
masters to consider carefully the views of a treating doctor. Capizzano v. Sec’y of
Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). However, the
views of a treating doctor are not absolute. Snyder v. Sec’y of Health & Human
Servs.,
88 Fed. Cl. 706, 745 n.67 (2009).
The Sanchezes argue that treating doctors have indicated that the vaccination
caused Trystan’s problems. They list four doctors. Pet’rs’ Remand Br. at 29. For
the reasons explained below, they overstate the significance of these reports.
Dr. Friedman. In 2010 and 2011, Dr. Friedman stated that Trystan might
have acute disseminated encephalomyelitis. Thus, she suggested that Trystan
could have “ADEM secondary to vaccine” and “other vaccine toxicity.” Exhibit
10 at 7 (Sept. 6, 2011).40
If Trystan suffered from ADEM, then Dr. Friedman’s opinion could be quite
valuable. However, Trystan does not have ADEM. Genetic testing shows that he
has Leigh’s syndrome. Thus, Dr. Friedman’s report does not advance the
Sanchezes’ claim that the vaccinations contributed to Trystan’s Leigh’s syndrome.
40
DTaP and other vaccines have been found to cause ADEM. E.g., Lerwick v. Sec’y of
Health & Human Servs., No. 06-847V, 2011 WL 4537874 (Fed. Cl. Spec. Mstr. Sept. 8, 2011).
75
Dr. Sharma. Akhil Sharma saw Trystan for a new well-child examination on
October 2, 2013. Exhibit 137 at 1. Under “past medical history,” Dr. Sharma has
recorded that Ms. Sanchez told him Trystan “Did well till 6 mo. Got 6 mo shots
for the first time and got fever and seizures [after] that followed by regression of
milestones.” Id. This “past medical history” concludes: “probable vaccine
induced injury.”
Id. Dr. Sharma repeats this history in his June 26, 2015 medical
record.
Id. at 8.
Dr. Sharma’s reports carry little persuasive value. The record appears to
reflect Ms. Sanchez’s account of the events in Trystan’s life as opposed to Dr.
Sharma’s evaluation. Even within Ms. Sanchez’s recollection, Ms. Sanchez seems
to indicate that following the vaccinations when Trystan was six months, Trystan
had a “fever and seizures.” While Ms. Sanchez may sincerely believe that Trystan
had a seizure on the night of February 16, 2009, the record does not persuasively
establish that a seizure happened then. Thus, to the extent that Dr. Sharma reached
an opinion that Trystan had a “probable vaccine induced injury,” Dr. Sharma’s
conclusion seems to derive from an erroneous starting point. As such, the
undersigned gives Dr. Sharma’s opinion about the cause of Trystan’s neurologic
problem little weight. See Dobrydnev v. Sec’y of Health & Human Servs., 566 F.
App’x 976, 983 (Fed. Cir. 2014) (noting special master may reject the testimony of
a doctor who examined the vaccinee when the doctor receives an inaccurate
history); Castaldi v. Sec’y of Health & Human Servs., 119 Fed. Cl. 407, 416
(2014) (determining that special master was not arbitrary in considering that the
reports from a treating doctor “were largely based on [the petitioner’s] recollection
rather than [the doctor’s] own observations”); Balasco v. Sec’y of Health &
Human Servs., No. 17-215V,
2020 WL 1240917, at *21 (Fed. Cl. Spec. Mstr. Feb.
14, 2020) (rejecting statements from treating doctors about diagnosis when the
treaters relied upon history that was not correct).
Dr. Haas. Dr. Haas first saw Trystan on August 7, 2012. Exhibit 26 at 1.
The date of this first visit was approximately three months after the onset hearing
at which Trystan’s family members testified. The history that Dr. Haas obtained is
similar to the testimony the family provided during that hearing. Dr. Haas
recorded:
Trystan was perfectly normal until 6 month vaccines. Parents
report he was saying mama, dada and supporting weight on his
legs at that time. Parents didn't do 2 month or 4 month shots,
then showed up for 6 month vaccines at 5 mo of age. (at this
visit noted to have normal development, rolling back to front
76
and standing when placed, passing objects hand to hand and
rake sand grasping small objects, sitting with support, no head
leg [sic “lag” may have been intended] with pull to sit) Got his
shots, then shortly developed fever and cranky. Then developed
congestion (1-2 weeks after). Were giving him Tylenol. Saw
PMD, Dx otitis media, gave Amox. The fever persisted and he
had inconsolable crying. 11 days after the vaccination, he had
an episode of ‘contortion’ in the upper limbs. He would stiffen
his arms behind his back, he would jerk his arms and his neck,
sometimes at same time, sometimes one after another. No loss
of consciousness. Would do this minutes at a time. Dad would
try to straighten his arms but they would snap back. He would
do this when awake and asleep. No post-ictal.
Exhibit 26 at 1. With respect to immunizations, Dr. Haas recorded: “Not up to
date. . . . Got sick (cough, fever, congestion) right after his second set, and then
started having seizures.” Id. at 2. After obtaining additional information and
conducting a physical exam, Dr. Haas assessed Trystan:
Trystan is a 4 year old boy who had acute onset regression and
dystonia at 6 months of age, following vaccination, which
repeated with the next set of vaccines at 12 months. [41] The
developmental regression reached a plateau soon after, and he is
making some developmental progress ever since. The dystonia
persists, with truncal hypotonia. He has basal ganglia
abnormalities on his MRI scan, and abnormally raised CoQ and
Complex IV in his muscle. The next step would be for his
muscle to be sent for mtDNA sequencing. We will search for
stored muscle.
Id. at 3.
41
The basis for Dr. Haas’s statement that something “repeated with the next set of
vaccines at 12 months” is not readily apparent as the history that Dr. Haas obtained does not
refer to anything happening after Trystan’s vaccinations at 12 months.
77
The Sanchezes emphasize that Dr. Haas wrote that the onset of Trystan’s
regression and dystonia came “following vaccination.” Pet’rs’ Remand Br. at 29. 42
Dr. Haas retained this wording in subsequent records as well. See exhibit 26 at 8
(Mar. 26, 2013); exhibit 52 at 1-2 (June 10, 2014).
On its face, a statement that the illness occurred “following vaccination”
presents a sequence of events. The recitation of a chronological sequence of
events is not the same as an opinion regarding causation. See Cedillo v. Sec’y of
Health & Human Servs., 617 F.3d 1328, 1347-48 (Fed. Cir. 2010); La Londe v.
Sec’y of Health & Human Servs.,
110 Fed. Cl. 184, 206 (2013), aff’d on other
ground,
746 F.3d 1334 (Fed. Cir. 2014); Langland v. Sec’y of Health & Human
Servs.,
109 Fed. Cl. 421, 439 (2013) (stating that the special master was not
arbitrary in finding that the records from treating doctors “reflect no more than
intake histories or temporal associations”); Caves v. Sec’y of Health & Human
Servs.,
100 Fed. Cl. 119, 139-40 (2011), aff’d without op., 463 F. App’x 932 (Fed.
Cir. 2012).
Furthermore, these three statements from Dr. Haas came before the genetic
mutations in Trystan were discovered. After the genetic mutations were identified,
Dr. Haas wrote a letter to other medical providers. Dr. Haas told Trystan’s other
doctors that “Trystan Evan Sanchez has a mitochondrial disease caused by
Complex II deficiency of the respiratory chain. This is a genetic disease causing in
Trystan dystonia, developmental delay, encephalopathy, neuromuscular
disease[, and an] abnormal MRI.” Exhibit 62 at 6. Here, Dr. Haas does not state
that the cause of Trystan’s disease was the vaccination.
Yet, Dr. Haas does not completely ignore the vaccinations. In a September
24, 2019 report, Dr. Haas stated that Trystan has “Leigh’s disease due to complex
II deficiency . . . This boy’s mitochondrial disease is life threatening and he can
deteriorate with stress situations including the possibility of fever after
immunization. For this reason it is medically acceptable for him to avoid
immunizations.” Exhibit 184 at 53.
A recommendation to avoid vaccinations is not necessarily the same as a
statement that a vaccine caused an injury. See Moberly v. Sec’y of Health &
Human Servs., 85 Fed. Cl. 571, 604-05 (2009), aff’d,
592 F.3d 1315 (Fed. Cir.
42
The Sanchezes also cite exhibit 53. However, exhibit 53 is not a report from Dr. Haas.
Exhibit 53 is a GeneDx report, dated November 5, 2014.
78
2010); Rickard v. Sec’y of Health & Human Servs., No. 09-729V, 2011 WL
1979601, at *12 (Fed. Cl. Spec. Mstr. Apr. 11, 2011) (indicating that the doctor
recommended avoiding future vaccinations as part of a standard practice).
Dr. Wong. Upon referral from Dr. Sharma, Derek Wong from the
Children’s Hospital of Los Angeles, division of medical genetics, saw Trystan on
January 28, 2016. In his history, Dr. Wong states that he is quoting a record from
Dr. Haas:
He had vaccines at five months of age, then had fever and
irritability. He developed congestion, and had a fever and otitis
[media]. 11 days after the vaccines, he had stiffening episodes
that lasted for 18 months.[43] After this episode, he lost head
control but regained it 1-2 months later.
Exhibit 139 at 1. The history in Dr. Wong’s report continues:
At 12 months of age, Trystan had some intermittent rigidity of
his extremities, head lag, and significant developmental delay.
[Ms. Sanchez] told me that he had vaccines at 12 months of age
that caused further developmental regression although I am
unclear on the sequence of events after reading Dr. Haas’s
notes. That note states that the patient had cough, fever, and
congestion after his 12 month immunizations, and that seizures
started after that point.
Id. at 1.44
Dr. Wong reviewed the results from other tests including the whole exome
sequencing showing the c.667delG and c.1571C>T mutations. According to Dr.
Wong, “[t]herefore the diagnosis of complex II deficiency secondary to SDHA
mutations was made, and specifically Leigh syndrome.” Id. at 2. When Dr. Wong
reviewed Trystan’s immunization status, Dr. Wong recorded: “Immunizations are
43
The basis for Dr. Wong’s January 2016 statement that Trystan had stiffening for 18
months is not readily apparent.
44
Rather than quoting Dr. Haas’s records, Dr. Wong appears to be significantly
paraphrasing the records. See exhibit 26 at 1-2.
79
not up to date. Note possible reactions to vaccines – developmental regression.”
Id. at 3.
All this description of Trystan’s condition precedes the passage that the
Sanchezes quote. Pet’rs’ Remand Br. at 75. In Dr. Wong’s assessment, he states
Trystan’s “manifestations include developmental regression, following vaccines
and/or viral syndrome.” Exhibit 139 at 5. However, the Sanchezes do not point
out that in the previous sentence, Dr. Wong wrote, “Trystan is a 7 year old male
with mitochondrial complex II deficiency secondary to compound heterozygous
mutations in the succinate dehydrogenase A (SDHA) gene.” Id.
Dr. Wong’s record provides little assistance to the Sanchezes. At best, like
Dr. Haas and Dr. Sharma, Dr. Wong recognizes a temporal sequence in which
Trystan’s developmental regression “follow[ed] vaccines and/or viral syndrome.”
But, even this statement from Dr. Wong must be placed in the context in which Dr.
Wong describes Trystan’s developmental regression as a “manifestation” of a
“mitochondrial complex II deficiency secondary to compound heterozygous
mutations.”
In summary, the records from four doctors who treated Trystan do not help
the Sanchezes meet their burden of showing that the DTaP vaccination contributed
to Trystan’s Leigh’s syndrome. Dr. Friedman presented her opinion before
Trystan’s Leigh’s syndrome was diagnosed after genetic studies. Dr. Sharma and
Dr. Haas obtained histories that are not entirely accurate. Even so, Dr. Sharma, Dr.
Haas, and Dr. Wong appear to present temporal sequences. Accordingly, while
these reports have been considered, they do not constitute persuasive evidence for
the Sanchezes.
VIII. Genetics
The previous sections (V, VI, and VII) constitute the Althen analysis and for
the reasons explained therein, the Sanchezes have not met their burden of proof
and, therefore, are not entitled to compensation. Nevertheless, the Secretary
presented an alternative and independent explanation for finding that the
Sanchezes are not entitled to compensation—Trystan’s genetic mutations.
Like many sections in this remand decision, this section begins with a
summary of the procedural posture (section A) because those steps are the basis for
determining the scope of remand (section B). Then, section C sets forth the
burdens with respect to alternative factors. Information about Trystan’s genetics,
the parties’ arguments, and a summary of the most important articles are developed
80
in sections D, E, and F, respectively. Finally, section G presents the reasons for
finding that the mutations constitute the sole substantial cause of Trystan’s Leigh’s
syndrome.
A. Procedural History regarding Genetics
As noted earlier, Trystan was tested for genetic mutations during this
litigation and the testing showed that he possessed two mutations. The testing
company, GeneDX, described both mutations as pathogenic. Exhibit 53.
The discovery of the genetic mutations added another aspect to the
Sanchezes’ claim that the vaccination harmed Trystan. The Sanchezes brought in
Dr. Niyazov because he has expertise in mitochondrial disorders. Dr. Niyazov
opined that the genetic mutation only predisposed Trystan to developing Leigh’s
syndrome and the vaccination caused this disposition to become a reality. Exhibit
68. Dr. Steinman, too, expressed a similar opinion, although the Sanchezes rely
less upon Dr. Steinman. Exhibit 95. The Secretary’s expert, Dr. Raymond, who,
like Dr. Niyazov, is board-certified in genetics opined that “Trystan Sanchez is a
child with Leigh syndrome secondary to mutations in the gene SDHA. This is the
sole cause of his neurologic condition.” Exhibit H at 8. The parties continued to
develop their points through additional expert reports, briefing in advance of the
hearing, and oral testimony during the December 2017 hearing.
The October 9, 2018 decision found that the Sanchezes did not meet their
burden of proof regarding Althen prongs 2 and 3. Thus, they were not entitled to
compensation. However, because the parties had invested so much into the
genetics issue, the undersigned offered additional views regarding the genetics
aspect of the case. The undersigned concluded that “Trystan’s actual course is
entirely consistent with what is known about his genetic mutations.” Decision at
41, 2018 WL 5856556, at *25.
Following the decision, the Sanchezes filed a motion for review. The
Sanchezes, however, did not present any argument regarding Trystan’s genetics.
Rather, on the thirty-ninth and final page of their motion, the Sanchezes asserted
that “[t]he perceived errors in this part of the Decision are not addressed in this
Motion. Petitioner[s] reserve[] the right to [do] so in the event the issue comes to
the forefront.” Pet’rs’ Mot. for Rev. at 39 n.34. The Secretary did not present any
argument regarding genetics. See Resp’t’s Resp. to Mot. for Rev. The Reply, too,
was silent on this issue. See Pet’rs’ Reply in Support of Mot. for Rev. The
Court’s Opinion and Order denied the motion for review without commenting on
the genetics. See Opinion and Order.
81
The parties’ briefs to the Federal Circuit were similar. Although the
Sanchezes’ initial brief did not discuss the comments in the October 9, 2018
decision regarding genetics, in their reply brief, the Sanchezes presented
essentially the same footnote as they used in their motion for review. Again, the
Sanchezes maintained that they “reserve[] the right to [address perceived errors in
the Decision regarding genetics] in the event the issue comes to the forefront.”
Reply of Appellants-Petitioners at 29 n.12.
During oral argument, a member of the Federal Circuit panel inquired
whether the Secretary was defending the October 9, 2018 decision on the basis of
the genetics. The Secretary stated that he was not.45
The Federal Circuit vacated the judgment based upon the October 9, 2018
decision because of errors in the Althen analysis. In remanding for correction of
these errors, the Federal Circuit permitted additional findings on the genetics issue:
Finally, it may be necessary for the special master to address a
question that was left open in the last two pages of the special
master’s decision denying compensation: whether the
Secretary showed, because of Trystan’s mutations, the timing
and severity of his Leigh’s syndrome would have been the
same, regardless of the effect of the vaccinations.
Sanchez, 809 F. App’x at 854. The Federal Circuit also stated that the special
master could “give the parties an opportunity to supplement the record with any
relevant medical research or reports postdating the hearing held by the special
master two and one-half years ago.” Id.
On remand, the undersigned allowed the parties to present additional reports,
see order, issued June 12, 2020, and the parties did so, addressing genetics along
with other issues. E.g., exhibits 189, 195 (both Dr. Niyazov), P, Q (both Dr.
Raymond). The parties’ experts also discussed genetics during the July 9, 2020
45
Oral Argument at 17:07-17:43, Sanchez v. Sec’y of Health & Human Servs., 809 F.
App’x 843 (2020) (No. 2019-1753), http://www.cafc.uscourts.gov/oral-argument-
recordings?title=Sanchez&field_case_number_value=2019-
1753&field date value2%5Bvalue%5D%5Bdate%5D=2020-02-07; see also Pet’rs’ Remand Br.
at 67, 89.
82
hearing. After the hearing, the parties made arguments regarding genetics in their
briefs.
B. Scope of Remand
Notwithstanding the Federal Circuit’s invitation to consider the genetics
issue, the Sanchezes argue that the undersigned cannot evaluate this evidence on
remand. They maintain, “The genetics portion of the Special Master’s decision
made it clear that it was not how the [special master] decided the case. Therefore, it
was not part of any appeal. The law of the case doctrine applies. Respondent did
not rely on this portion of the Decision at either the Motion for Review or the
Federal Circuit Appeal.” Pet’rs’ Remand Br. at 89; accord Pet’rs’ Reply on
Remand at 20.
However, the Sanchezes appear to misapprehend the law of the case
doctrine. A trial court’s failure to rule on one claim or defense does not create a
waiver for the party advancing the claim or defense. See Exxon Chem. Patents,
Inc. v. The Lubrizol Corp., 137 F.3d 1475 (Fed. Cir. 1998) (an appellate
conclusion that a party did not literally infringe a patent does not prevent the
plaintiff from seeking a new trial under the doctrine of equivalents); Laitram Corp.
v. NEC Corp.,
62 F.3d 1388, 1395 (Fed. Cir. 1995) (reinstating a jury’s verdict
decided on literal infringement and the doctrine of equivalents grounds, based only
on the appellate determination of error with respect to the literal infringement
claim and without reaching the doctrine of equivalents issue).
C. Burdens regarding Alternative Factor
When petitioners carry their burden to show that a vaccine was the cause-in-
fact of an injury, the Secretary may rebut this showing by establishing that the
injury is “due to factors unrelated to the administration of the vaccine.” 42 U.S.C.
§ 300aa–13(a)(1)(B).46 For the government to carry its burden, “the Secretary
refutes the prima facie finding that the vaccination is both the ‘but for’ cause and a
‘substantial factor’ in bringing about an alleged injury. . . . Because the factor
unrelated must be the ‘sole substantial factor,’ the Secretary must establish that the
factor unrelated, not the vaccination, actually caused the injury alleged.”
Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363, 1369 (Fed. Cir.
46
Because the Sanchezes have not met their burden to show that the DTaP vaccine
contributed to Trystan’s injury, the burden of proof actually never shifted to the Secretary.
However, the following analysis assumes that the Sanchezes met their burden of proof.
83
2013). The Secretary’s burden with respect to alternative causation is “the same
as” the standards for “petitioner’s proof of actual causation in fact in off-table
cases.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir.
1994). And, the petitioner’s burden is preponderance of the evidence. Bunting v.
Sec’y of Health & Human Servs.,
931 F.2d 867, 873 (Fed. Cir. 1991).
The Sanchezes argue that the Secretary’s burden to establish an alternative
factor as the cause of an injury is greater than a petitioner’s burden to establish
causation-in-fact. For this proposition, the Sanchezes rely upon de Bazan v. Sec’y
of Health & Human Servs., 539 F.3d 1347, 1351-54 (Fed. Cir. 2008). Pet’rs’
Remand Br. at 10-11, 74-75; Pet’rs’ Reply on Remand at 16-17.
In that case, Adela Quintana de Bazan received a tetanus-diphtheria vaccine
and within eleven hours developed symptoms of a neurologic disease, acute
disseminated encephalomyelitis (ADEM). 539 F.3d at 1349-50. After a hearing,
the special master credited the Secretary’s expert who had opined that eleven hours
was too short to infer causation. On a motion for review, a judge of the Court of
Federal Claims “held that the special master had erred by improperly failing to
shift the burden to the government. The court held that the finding that the eleven-
hour onset of ADEM was not within a medically appropriate timeframe to attribute
to the vaccine was tantamount to finding that de Bazan had failed to prove that no
other cause could have caused her injuries.”
Id. at 1350.
After remand in which
the Secretary presented no new evidence, the special master found in favor of the
petitioner. The Secretary then appealed the judgment to the Federal Circuit.
The Federal Circuit reversed. The Federal Circuit stated, “the court
misunderstood our precedents.” Id. at 1353. The Federal Circuit held that in
requiring Ms. de Bazan to show her ADEM arose in an appropriate amount of time
after the vaccination, the special master did not impose an additional burden on
her. In this context, the Federal Circuit stated that after a petitioner meets her
burden under Althen, “The government then must provide that [contrary] proof by
identifying a particular such factor (or factors) and presenting sufficient evidence
to establish that it was the sole substantial factor in bringing about the injury.”
Id.
at 1354. However, the Federal Circuit was not called upon to address dimensions
of the “sole substantial factor” as the Secretary had not presented any evidence
regarding a factor unrelated to the vaccine.
Id.
The Federal Circuit has ruled that a special master’s finding that a genetic
mutation was the “sole substantial factor” to cause a child’s disease satisfies the
respondent’s burden in showing that the injury was due to factors unrelated to the
84
vaccine. See Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363 (Fed.
Cir. 2013); Stone / Hammitt v. Sec’y of Health & Human Servs.,
676 F.3d 1373
(Fed. Cir. 2012) (separate cases considered together on appeal); see also Snyder v.
Sec’y of Health & Human Servs., 553 F. App’x 994 (Fed. Cir. 2014). While the
children in all three cases47 had a mutation in the SCN1A gene, the most analogous
case is Stone / Hammitt.
When Rachel Hammitt was approximately four months old, she received a
dose of the DTaP vaccine and several other vaccines. That evening, she
experienced a febrile seizure for which she remained hospitalized for several days.
About one month later, Rachel had a second seizure and was again treated in the
hospital. Because of repeated seizures, she was diagnosed with epilepsy by her
first birthday. Testing later showed she has a mutation in the SCN1A gene. Stone,
676 F.3d at 1375.
The petitioner in both Stone and Hammitt relied upon an opinion from
Marcel Kinsbourne.48 “A key component of Dr. Kinsbourne's theory is that the
initial seizure caused some form of lasting brain injury that had downstream
consequences for both children, specifically a lowered seizure threshold.
Accordingly, the special master sought evidence of brain damage resulting from
the initial febrile seizures.” Id. at 1384.
The petitioners failed to establish their
cases because “Dr. Kinsbourne was unable to identify any evidence that either
child had suffered brain damage as a result of those seizures.”
Id. Thus, on
remand, the special master found the petitioner in Hammitt “had not made a prima
facie case.”
Id. at 1378.
On appeal the Federal Circuit ruled that the special
master’s determination was not arbitrary because the petitioners “failed to show
that the vaccines caused any brain damage.”
Id. at 1384.
The special master also found primarily based upon the testimony of Dr.
Raymond, that “respondent proved by a preponderance of the evidence that [the]
SCN1A gene mutation was the sole cause and was principally responsible for [the
child’s disease].” Id. at 1378-79
(second alteration added, and citation omitted).
At the Federal Circuit, the appellants-petitioners challenged a reliance on Dr.
47
Actually, five children because the Federal Circuit consolidated two cases in Stone and
Snyder.
48
The special master expressed concerns about Dr. Kinsbourne’s reliability because he
has not practiced pediatric neurology since 1981. This weakness in Dr. Kinsbourne’s
background is not a problem for Doctors Steinman and Niyazov.
85
Raymond’s opinion. However, the Federal Circuit found that the special master
was not arbitrary in relying upon Dr. Raymond because, in part, Dr. Raymond
considered multiple factors for finding that the SCN1A mutation was the sole
cause of the children’s seizure disorder. Those factors were:
(1) the gene mutation was not inherited but arose de novo, so
the absence of SMEI in either parent was not probative; (2) the
mutation resulted in a non-conservative amino acid change, i.e.,
the mutation produced a new amino acid having very different
physical properties from the corresponding amino acid found in
normal individuals; (3) the mutation affects a functionally
important region, a portion of the sodium channel in neurons
that is crucial to the normal functioning of the nervous system;
(4) the mutation occurs in an area that is well conserved across
species, “indicating that changes here are probably not well
tolerated”; (5) there is an absence of the mutation in the normal
population; (6) medical reports show that a mutation in the
same location has been associated with SMEI; and (7) between
80 and 90 percent of patients with SMEI have an SCN1A gene
mutation.
Id. at 1383.
The Federal Circuit stated that based upon this evidentiary support,
“we cannot conclude that the special master’s conclusion that the SCN1A gene
mutation was solely responsible for [Amelia Stone’s] SMEI was arbitrary or
capricious.”
Id. at 1384.
Here, the Sanchezes give little recognition to the SCN1A cases, saying,
without elaboration, that their case is “unlike” the SCN1A cases. Pet’rs’ Remand
Br. at 76. Rather, the Sanchezes emphasize a precedential opinion that the Federal
Circuit issued while their case was on remand, Sharpe v. Sec’y of Health & Human
Servs., 964 F.3d 1072 (Fed. Cir. 2020).49
Heidi Sharpe, the mother of L.M., noticed her daughter having episodes of
“spacing out” during which L.M. was not responsive for several seconds when she
49
While the Secretary was invited to comment upon Sharpe, the Secretary stated, “the
Federal Circuit has not yet issued its mandate in Sharpe; accordingly, it is premature for the
parties to be speculating about the potential effect of the Sharpe panel’s decision.” Resp’t’s
Remand Br. at 25.
86
was approximately five months old. Id. at 1076.
At six months old, L.M. received
a series of vaccination, including the DTaP vaccine. Later that evening, L.M. was
lethargic, had poor muscle tone, and did not eat. L.M.’s mother called the
hospital’s emergency room twice and her pediatrician later that morning.
According to L.M.’s mother, for the next three days, L.M. remained lethargic, had
poor head control, and did not interact with her environment.
Id. Five days after
vaccination, L.M. had a seizure for which she was brought to the hospital. Doctors
stated that she had “fairly poor head control.”
Id. She was diagnosed with
infantile spasms. At some point, a genetic mutation was discovered.
L.M.’s mother alleged that L.M. had a pre-existing seizure disorder and the
vaccines significantly aggravated it. 50 Under this cause of action, Ms. Sharpe is
required to establish the six elements first enumerated in Loving v. Sec’y of Health
& Human Servs., 86 Fed. Cl. 135, 144 (2009).
Sharpe, 964 F.3d at 1080. The
special master found that Ms. Sharpe had failed to establish elements 3 (a
significant aggravation of the prior condition), 4 (a medical theory), and 5 (a
logical sequence of cause and effect). The special master also found that L.M.’s
“gene mutation, and not the vaccination, was the sole, substantial cause of L.M.’s
significantly aggravated seizure disorder.”
Id.
The Federal Circuit ruled that the special master erred on all four points. For
the Sanchezes’ case, the most important comments from the Federal Circuit
include a holding that petitioners do not bear the burden of establishing that the
vaccinee’s current condition is worse than the normal and expected course of the
underlying disorder. The Federal Circuit also quoted testimony from the
Secretary’s witness that “[t]he dream of the geneticist is to find genotype-
phenotype correlation.”
Id. at 1082
(citation omitted). The Federal Circuit also
found that the special master’s finding that the genetic mutation was the likely sole
substantial factor causing L.M.’s severe seizure disorder was not supported by
substantial evidence. The record did not support the special master’s conclusion
because the specific mutation in L.M. “generally result[s] in non-severe, non-
cognitive disorders.”
Id. at 1086. For these reasons (and more), the Federal
Circuit vacated the judgment based upon the special master’s decision.
50
Ms. Sharpe also alleged that L.M. experienced a significant aggravation of her seizure
disorder due to the DTaP vaccine and claimed compensation as an on-Table injury. The special
master denied compensation on that theory and the Federal Circuit affirmed for reasons not
relevant to the Sanchezes’ case.
87
D. Trystan’s Genetic Mutations
During initial entitlement proceedings, the Sanchezes introduced evidence of
Trystan’s specific genetic mutations. The October 9, 2018 decision articulated
these genetic mutations as follows:
Trystan inherited two heterozygous mutations in his SDHA
gene. Because of the nature of the mutations and their effect on
the SDHA protein, the mutations are considered pathogenic.
The parties dispute whether these two mutations made
Trystan’s disease a fait accompli.
To understand the potential effect of Trystan’s inherited
mutations on Trystan’s clinical course, it is important to review
Trystan’s specific mutations and what is known about them.
Trystan’s two mutations in his DNA are referred to as
c.1571C>T and c.667delG. Exhibit 59 at 1. The first indicates
that at location 1571 in the gene, a cytosine (C) has been
replaced by a thymine (T). The second indicates that a guanine
(G) that is supposed to be present at position 667 has been
deleted. In the case of the first, this mutation changes the
nucleic acid code so that where there is supposed to be an
alanine in the protein, the cell now puts a valine (p.Ala524Val).
In the case of the second, the mutation changes the nucleic acid
sequence in a manner that creates a premature stop signal in the
place of a signal for an amino acid. In other words, the cell
believes that no more of the nucleic acid chain needs to be
translated into amino acid, resulting in a shortened, or
truncated, protein (p. Asp223IlefsX3).
Decision at 31, 2018 WL 5856556, at *19.
E. Overview of Parties’ Positions regarding Genetics
The Secretary maintains that “[t]he onset and progression of Trystan’s
unfortunate condition is entirely explained by what is currently known about
Leigh’s syndrome generally and Trystan’s gene mutations specifically.” Resp’t’s
Remand Br. at 26. The Secretary’s position comes from the opinion of Dr.
Raymond, who relies primarily on the Parfait article, which is discussed below.
88
Primarily through the opinion of Dr. Niyazov, the Sanchezes maintain that
Trystan’s genetic mutations were not sufficient, by themselves, to cause him to
suffer Leigh’s syndrome. Trystan’s genetic mutations would cause Leigh’s
syndrome only after a stressful event, which was his vaccination. See Pet’rs’
Remand Br. at 68.51 Dr. Niyazov relies primarily upon the Levitas article.
F. Important Articles regarding Mutations
In the October 9, 2018 decision, the undersigned outlined and summarized
relevant articles presented by the parties as follows:
Exhibit H, tab 7 (Thomas Bourgeron et al., Mutation of a
Nuclear Succinate Dehydrogenase Gene Results in a
Mitochondrial Respiratory Chain Deficiency, 11 Nature 144-49
(1995)) presents the first account of a mutation in SDHA being
associated with a mitochondrial disease in humans. In this
study, the authors reported that two sisters both had a
homozygous mutation in SDHA (c.1684 C>T) and that both
sisters developed Leigh’s syndrome at 10 months of age. One
died at 19 months and another was still alive at 13 months.
Exhibit 110 (Beatrice Parfait et al., Compound Heterozygous
Mutations in the Flavoprotein Gene of the Respiratory Chain
Complex II in a Patient with Leigh Syndrome, 106 Human
Genetics 246-43 (2000)) presents a case study of a child with
Leigh’s syndrome who, like Trystan, had a compound
heterozygous mutation of her SDHA gene. The child in Parfait
shared one of his two mutations with Trystan (c.1571 C>T).
However, the other mutation was distinct between the two
children. Little is known about the course of the disease for the
young child presented in the Parfait article, other than that she
presented with Leigh’s syndrome at 9 months of age,
demonstrating psychomotor delays and cerebellar ataxia. The
authors in the Parfait article took the additional step of showing
51
The Sanchezes state that the approximately three weeks between the conclusion of the
hearing and the deadline for the submission of their initial brief constituted an “[i]nsufficient
time . . . to outline in full all of the reports and testimony by Dr. Niyazov regarding the gene
mutations[,] the variable expressivity[,] and partial expressivity.” Pet’rs’ Remand Br. at 70.
However, their argument spans many pages. See id. at 66-82, 89-90.
89
that the reduced functioning of the young child’s SDH protein
was attributable to the c.1571C>T mutation (the mutation
Trystan had), confirming the mutation’s pathogenicity.
Exhibit 94 (Rudy Van Coster et al., Homozygous Gly555Glu
Mutation in the Nuclear-Encoded 70 kDa Flavoprotein Gene
Causes Instability of the Respiratory Chain Complex II, 120A
Am. J. Medical Genetics 13-18 (2003)) presents the case study
of a young child with a homozygous mutation in the SDHA
gene (c.1664 G>A) whose symptoms developed at five months
of age and then died two weeks later following a respiratory
infection. Though the child may have had Leigh’s syndrome,
she “died in infancy before any sign of Leigh syndrome could
develop.”
Id. at 4.
Exhibit H, tab 28 (R. Horvath et al., Leigh Syndrome Cased by
Mutations in the Flavoprotein (Fp) Subunit of Succinate
Dehydrogenase (SDHA), 77 J. Neurology Neurosurgery
Psychiatry 74-76 (2006) presents the case of a young girl with a
compound heterozygous mutation in her SDHA gene. Her two
mutations were not seen in any other study. The patient first
showed signs of Leigh's syndrome at five-months of age. While
she had reached 10 years at the time the study was published,
she had also shown an arrest of her psychomotor development
and experienced recurrent seizures.
Exhibit H, tab 27 (Alistair T. Pagnamenta et al., Phenotypic
Variability of Mitochondrial Disease Caused by a Nuclear
Mutation in Complex II, 89 Molecular Genetics and
Metabolism 214-21 (2006)) presents the case of a young boy
with the exact same mutations presented in exhibit 94 (Van
Coster). However, in contrast to the patient described in Van
Coster, the patient in Pagnamenta did not develop symptoms of
Leigh’s syndrome until 22 months of age. While his onset was
rapid, he began showing an improved clinical picture after
turning four. At the time the article was published, the child
was 10 years old and showed variably impaired motor function,
but did not appear to manifest any cognitive deficits and
attended a mainstream school.
90
Exhibit 79 (Aviva Levitas et al., Familial Neonatal Isolated
Cardiomyopathy Caused by a Mutation in the Flavoprotein
Subunit of Succinate Dehydrogenase, 18 European J. Human
Genetics 1160-65 (2010)) is the most recently published article
in the record concerning the significance of SDHA mutations.
The Levitas article is unique for two reasons. First, the authors
presented an examination of fifteen individuals from two large
consanguineous families, allowing for better discrimination
about the penetrance of the mutation. Second, the patients did
not present with Leigh’s syndrome. Instead, with the exception
of one patient, the subjects had, or had died of,
cardiomyopathies of various severities. The onset of the
disease, or death, occurred at earlier than one year of age in all
the children studied. This is all the more fascinating because
the mutation involved in Levitas was the same exact mutation
that was associated with Leigh’s syndrome in Van Coster and
Pagnamenta. Nonetheless, not a single family member
developed Leigh’s syndrome. Even more, at least one patient,
the father, who had the homozygous mutation that was also
present in Van Coster and Pagnamenta (c.1664 G>A), had no
symptoms of disease at all. This astonished the researchers and
they performed several follow-up studies to try to explain this
finding, though they had no success. Importantly, it was
confirmed that this patient had a loss of function of the SDH
gene, much as was the case in Parfait, but nonetheless did not
develop any disease.
Decision at 31-33, 2018 WL 5856556, at *19-20.
In December 2017, when Dr. Niyazov and Dr. Raymond testified, Trystan’s
second mutation (the c.667delG mutation) had not been reported in the literature.
Tr. 2089. With the passage of time, doctors have reported this mutation in the
context of epilepsy and paraganglioma tumors. Exhibit 189 (Dr. Niyazov’s June
19, 2020 report) at 2; see also exhibit P (Dr. Raymond’s June 19, 2020 report) at
5.52
52
Dr. Raymond did not note the appearance of the c667delG mutation in epilepsy and
paraganglioma tumors. See exhibit P. Given that this oversight was brought up during his
91
G. Evaluation of the Genetic Evidence
After discussing pathogenicity and penetrance, the October 9, 2018 decision
found that “Trystan’s actual course is entirely consistent with what is known about
his genetic mutations.” Decision at 41, 2018 WL 5856556, at *25. However, the
undersigned did not make an explicit finding as to whether the genetic mutations
were the sole substantial cause of Trystan’s Leigh’s syndrome.
The undersigned now finds that Trystan’s mutations were the sole
substantial cause of his Leigh’s syndrome. While the reasons for this finding are
presented below, the undersigned first explains why this finding is being made
now, as opposed to October 2018.
The October 9, 2018 decision did not require a finding with respect to the
genetics issue. It was sufficient to find that the Sanchezes did not carry their
burden regarding Althen prong 2 and Althen prong 3. When special masters can
resolve a case a based upon one issue, they do not necessarily need to address all
issues. See, e.g., Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355,
1365 (Fed. Cir. 2012); Vaughan v. Sec’y of Health & Human Servs.,
107 Fed. Cl.
212, 222 (2012).
It is still correct that the genetics issue is an alternative basis for denying
compensation to the Sanchezes in that, even after consideration of the arm
contortions, they have not met their burdens regarding Althen prong 2 and Althen
prong 3. See sections VI and VII above. Nevertheless, under the circumstances of
this case, a finding regarding genetics will advance judicial economy because as
part of the remand process, the undersigned has re-reviewed the evidence
regarding genetics.
Dr. Niyazov has made some points regarding the incomplete penetrance of
some SDHA genetic mutations. The results from the Levitas article cannot be—
and are not—dismissed out of hand.
On the other hand, the Secretary’s burden to show that the genetic mutations
are the sole substantial cause of Trystan’s Leigh’s syndrome is a simple
preponderance of the evidence. The Secretary does not have to present either a
testimony, Tr. 2089, 2092-96, 2134-35, 2169, the Secretary’s statement that “no clinical
information [has been] provided” seems inaccurate. Resp’t’s Remand Br. at 28.
92
clear and convincing case or a case beyond a reasonable doubt. The Secretary is
only required to tip the metaphorical scales of justice.
The Secretary has carried this burden in this case. Much as he was in Stone,
Dr. Raymond was a credible expert. Dr. Raymond’s reliability comes, in part,
from his reliance on the Parfait paper. As indicated in the title of the article, the
child in Parfait suffered from compound heterozygous mutations in the
flavoprotein gene of the respiratory chain complex II. “Heterozygous” means that
one of the child’s parents provided one normal gene and one of the child’s parents
provided one mutation. 53 “Compound” means that the child suffered two different
heterozygous mutations.
Dr. Raymond’s reliance on Parfait stems from the similarity in genetic
mutations between the Parfait child and Trystan. In both children, the genetic
mutation at codon 524 is exactly the same. Tr. 478, 537 (Dr. Niyazov). The
second mutation created a premature stop code in the gene, resulting in a shorter
protein. Although the details of the second genetic mutation in the Parfait child
and Trystan do not match entirely, the end result--a shortened protein—is the
same. Tr. 814-15, 980.
After the Parfait researchers discovered the mutations, they explored the
significance. With respect to the c.1571C>T mutation, the mutation that Trystan
shares, the researchers determined that it was “absent from 150 controls.” Beatrice
Parfait et al., Compound heterozygous mutations in the flavoprotein gene of the
respiratory chain complex II in a patient with Leigh syndrome, 106 Hum. Genetics
236, 236 (2000), filed as exhibit 110. The researchers used fibroblasts to see how
the gene performed in tissue cultures. Id. at 241; Tr. 539. Their experiment
“confirm[ed] the deleterious effect of this mutation.” Exhibit 110 (Parfait) at 241.
The Parfait researchers did not perform a functional analysis on the second
mutation, which may result in a shortened protein. Tr. 995. However, as Dr.
Niyazov recognized, shortened proteins often contribute to disease because the
entire protein is not created. Tr. 912-13; see also Tr. 806-07 (Dr. Raymond
discussing GeneDx report that truncation mutations are almost always pathogenic).
While Dr. Raymond opined that the Parfait article supported a finding that
Trystan’s genetic mutations, and solely his genetic mutations, caused Trystan’s
53
Although Dr. Niyazov maintained that one of the Parfait child’s mutations was
homozygous, Tr. 489, 978, this interpretation seems to be erroneous. Tr. 1001-02.
93
Leigh’s syndrome, Dr. Niyazov’s response to Parfait varied. On the one hand, Dr.
Niyazov agreed that Trystan could be compared to the child in Parfait because one
of the two mutations (the 524 mutation) was the same. Tr. 488. Dr. Niyazov
agreed that the 524 mutation was “deleterious” and an “altering function
mutation.” Tr. 541, 543. Despite this agreement, Dr. Niyazov would not concede
that the mutation caused disease because Dr. Niyazov would “need to see the
clinical features of the patient.” Tr. 542. He defended his position by citing
Levitas.
In the respect of needing to see clinical features of the patient, Dr. Niyazov
seems to be demanding a level of scientific certainty that exceeds the
preponderance of the evidence standard. Contrary to a question posed by the
Sanchezes’ attorney during cross-examination of Dr. Raymond, the Parfait article
does not represent a case report in which the researchers memorialized an event
and an outcome. See Tr. 896-97. While the Federal Circuit in Sharpe warned
against relying upon a single case study, Sharpe, 964 F.3d at 1084 (discussing the
Ambry patient), the Parfait article is not a simple case report. Instead, the Parfait
researchers studied how the gene would be expressed in cell cultures. Exhibit 110
(Parfait) at 241. This experiment strengthens the value of the Parfait article,
making it worthy of more weight than case reports, which petitioners in the
Vaccine Program often supply. See, e.g., Campbell v. Sec’y of Health & Human
Servs.,
97 Fed. Cl. 650, 668-69 (2011); Tompkins v. Sec’y of Health & Human
Servs., No. 10-261V,
2013 WL 3498652, at *23-24 (Fed. Cl. Spec. Mstr. June 21,
2013), mot. for rev. denied,
117 Fed. Cl. 713 (2014). While Dr. Niyazov may be
correct from a scientist’s perspective that an in vivo, as opposed to in vitro,
experiment may be more informative, Dr. Niyazov has not proposed how an in
vivo study could be conducted on the 524 mutation. Furthermore, the Vaccine
Program does not demand this level of proof from petitioners when they attempt to
establish that a vaccine harmed them. Consequently, the Secretary cannot be held
to a standard of proof that requires scientific certainty. Knudsen v. Sec’y of Health
& Human Servs.,
35 F.3d 543, 549 (Fed. Cir. 1994).
The gene expression studies are conducted, as far as the undersigned is
aware, to minimize the contribution, if any, from environmental factors, such as
vaccinations. And based upon the gene expression studies in Parfait, Dr. Niyazov
appropriately conceded that the researchers had determined that the 524 mutation,
which is the mutation Trystan shares with the Parfait child, is an “altered function”
mutation. Tr. 543. From this concession that the 524 mutation alters the function
of its associated protein, it seems reasonable to conclude that the altered function
will lead to a disease, especially when that conclusion is supported by Dr.
94
Raymond’s opinion. From the conclusion that the 524 mutation is likely to cause a
disease, it also seems logical to conclude that the specific disease a compound
heterozygous mutation involving the 524 gene is likely to cause is Leigh’s
syndrome because the Parfait child developed Leigh’s syndrome.
Additional support for the finding that the 524 mutation in combination with
the other mutation caused Trystan’s Leigh’s syndrome can be found by examining
the factors upon which Dr. Raymond relied in Stone.54
Factor in Stone Trystan’s case
(1) the gene mutation was not inherited
Trystan inherited one mutation from
but arose de novo, so the absence of
each parent. Neither parent had both
SMEI in either parent was not
mutations.
probative;
(2) the mutation resulted in a non-
conservative amino acid change, i.e.,
the mutation produced a new amino
Present in Trystan’s case. The second
acid having very different physical
mutation produced a shortened protein.
properties from the corresponding
amino acid found in normal
individuals;
(3) the mutation affects a functionally
important region, a portion of the The gene expression studies on the 524
sodium channel in neurons that is mutation in Parfait suggest that the
crucial to the normal functioning of the relevant region is crucial.
nervous system;
(4) the mutation occurs in an area that
is well conserved across species, The SDHA gene is highly conserved
“indicating that changes here are across species. Tr. 527 (Dr. Niyazov).
probably not well tolerated”;
54
By returning to the list of factors in Stone, the undersigned is not suggesting that the
list amounts to some sort of legal test. However, given that the Federal Circuit in Stone found
Dr. Raymond’s ultimate conclusion not arbitrary, the methodology or factors that he considered
appear relevant.
95
This appears to be true for Trystan.
The Parfait researchers did not find the
524 mutation in 150 controls. See Tr.
909 (Dr. Raymond’s testimony about
(5) there is an absence of the mutation
lack of appearance in the normal
in the normal population;
population), 2169-70 (Dr. Niyazov
discussing, in the context of the Parfait
article, an absence of cases with
Trystan’s specific genetic mutations).
Parfait constitutes a single report (not
plural reports) that a compound
(6) medical reports show that a
heterozygous mutation has been
mutation in the same location has been
reported in Leigh’s syndrome. But the
associated with SMEI;
c.667delG has not been reported in
Leigh’s syndrome.
(7) between 80 and 90 percent of
patients with SMEI have an SCN1A Not present.
gene mutation.
Thus, most of these seven factors tend to align with a finding that Trystan’s
compound heterozygous mutation caused his Leigh’s syndrome.
While a strength to Dr. Raymond’s opinion is that he based his analysis on
the genetic mutations that Trystan has, Dr. Niyazov’s opinion is relatively weaker
because he relies upon Levitas, which reported results on a different genetic
mutation. Dr. Niyazov’s reliance on Levitas is not irrational for Levitas does
illustrate the point that SDHA genes can have variable expressivity. However,
Levitas merits less weight than the Parfait article that included a gene expression
study on the gene that affects Trystan. In other words, Levitas and Dr. Niyazov’s
opinion about Levitas and the other articles he has cited might prevent a finding
that the Secretary had clearly and convincingly established the genetic mutations as
the sole substantial cause. But, the value of Levitas and Dr. Niyazov’s opinion is
not so strong to defeat a claim based upon a preponderance of the evidence.
In addition, despite receiving inaccurate histories concerning Trystan’s
health in the months following the vaccination, two doctors have linked Trystan’s
genetic mutation to his Leigh’s syndrome. As noted above, Dr. Wong, a medical
96
geneticist, stated “Trystan is a 7 year old male with mitochondrial complex II
deficiency secondary to compound heterozygous mutations in the succinate
dehydrogenase A (SDHA) gene.” Exhibit 139 at 5. Dr. Haas also told other
doctors that “Trystan Evan Sanchez has a mitochondrial disease caused by
Complex II deficiency of the respiratory chain. This is a genetic disease . . . .”
Exhibit 62 at 6. These statements reinforce the finding that the pair of genetic
mutations is the sole substantial cause for Trystan’s Leigh’s syndrome.
IX. Summary
After the Federal Circuit’s mandate, the undersigned identified four issues
within the scope of the Federal Circuit’s remand. Order, issued June 12, 2020.
While the reasoning is explained above, the resolution is set forth below concisely.
Issue A: Trystan’s neurologic state in February 2009.
In February 2009, Trystan was neurologically normal.
Issue B: Trystan’s health from end of February 2009 to end of May
2009.
During this time, Trystan suffered from colds periodically. He did not
develop any neurologic problems until he began to lose skills no sooner than May
1, 2009. After May 1, 2009, he continued to lose skills.
Issue C: Trystan’s health in August to October 2009.
From May to August and August to October 2009, Trystan declined
neurologically. However, this decline does not constitute a rechallenge.
Issue D: Leigh’s syndrome.
Trystan’s compound heterozygous mutations are the sole substantial cause
of his Leigh’s syndrome.
X. Conclusion
The Sanchezes have demonstrated their love and concern for Trystan by,
among other things, their persistence in this litigation. Through the Sanchezes’
dedication, the Federal Circuit identified an error in the October 9, 2018 decision
and remanded the case.
97
On remand, the corrected record does not show that the February 5, 2009
DTaP vaccination harmed Trystan. Although Trystan contorted his arm on
February 16, 2009, this isolated event was not a manifestation of a neurologic
problem. For the relevant time after the February 5, 2009 vaccine, Trystan was
developing normally.
Furthermore, Trystan’s genetic mutations are likely to be the sole substantial
cause for his Leigh’s syndrome. The genetic explanation constitutes an alternative
reason to find that the vaccination did not harm Trystan.
Pursuant to Vaccine Rule 28.1(a), the Clerk’s Office is instructed to deliver
this decision to the judge assigned to this case. In the absence of a motion for
review, the Clerk’s Office is instructed to enter judgment in accord with this
decision.
IT IS SO ORDERED.
s/ Christian J. Moran
Christian J. Moran
Special Master
98
