Sanchez v. Secretary of Health and Human Services

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

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(September 28, 2011), doctors had not reached a diagnosis about Trystan. “The

diagnosis of Trystan Sanchez’[s] disorder has defied the best medical scientists at

three university medical schools as well as other treating physicians for now.”

Exhibit 2 at 2. Nevertheless, the lack of diagnosis did not prevent Dr. Steinman

from offering an opinion. “What we do know, however, is that Trystan Sanchez

was given multiple vaccines, he suffered from fever and he suffered from

seizures.” Id.

Dr. Steinman’s statement that “we do know . . . he suffered from seizures”

suggests a level of certainty that was inconsistent with an earlier portion of Dr.

Steinman’s report. In reviewing the events in Trystan’s history, Dr. Steinman

stated: “Eleven days later in the context of a febrile illness, he may have had a

seizure, manifest by stiffening and ‘holding his arm behind his back with a lot of

tension and jerked his head back.’” Id. at 1 (emphasis added).

Regardless, the remainder of Dr. Steinman’s report is premised upon Trystan

having a seizure. Dr. Steinman summarized his report as presenting an opinion

that “the vaccines due to their components, triggered seizures and that if not for

this vaccine induced seizure disorder, then Trystan Sanchez would not have

suffered such devastating neurological consequences.” Id. at 10. Over the next

four pages, Dr. Steinman presented theories of how the vaccines could cause

seizures. Id. at 10-14. Despite having Mr. Sanchez’s description of Trystan’s

unusual arm movements available to him, nowhere in Dr. Steinman’s first report

does he suggest that the behavior Mr. Sanchez described in his affidavit constituted

dystonia.2

The Secretary challenged the Sanchezes’ entitlement to compensation in his

report, filed pursuant to Vaccine Rule 4 on February 28, 2012. The Secretary

maintained that the Sanchezes “have not demonstrated the threshold facts upon

which the claim is based. Specifically, petitioners have not shown that Trystan

suffered from either seizures or developmental delays within an appropriate

temporal relationship to the February 5, 2009 vaccines.” Resp’t’s Rep. at 11. The

Secretary commented that no medical record created around February 2009

corroborates assertions made in the affidavits from the Sanchez family. Id. at 12.

With his report, the Secretary filed a report from Gerald Raymond, a specialist in

2

Dystonia is “dyskinetic movements due to disordered tonicity of muscle.” Dorland’s

Illustrated Medical Dictionary 576 (32d ed. 2012).

5

genetics and neurology, who has written many reports and testified for the

Secretary during this case. Exhibit A.

Because the parties and their experts disputed whether Trystan displayed

unusual arm movements starting in February 2009, the undersigned received oral

testimony from the five family members on May 15, 2012, in San Diego,

California.3 After the hearing, a status conference was held on May 29, 2012.

In the status conference, the undersigned discussed how the parties could

assist in resolving factual disputes. The process for bringing forward disputed

factual issues had at least three steps. The Sanchezes were instructed to propose a

series of facts, citing evidence supporting their assertion of facts. The Sanchezes

were directed to transmit their proposal to the Secretary and not to file their

proposed submission. The Secretary was instructed to respond to each proposed

finding of fact, either agreeing or disagreeing. If the Secretary disputed the

proposed assertion, the Secretary was to cite evidence supporting his position. The

Secretary was also not expected to file his response. Once the Sanchezes received

this document, they could comment. This back-and-forth was expected to continue

until the parties presented all their points. Then, and only then, the parties were

expected to submit a final version incorporating, in one document, all the

arguments regarding any factual disputes. After the parties had engaged in this

process for about four months, another status conference was held on October 11,

2012. The parties reported that they were close to finishing this process. Order,

issued Oct. 12, 2012.

The parties submitted a document titled “Joint Statement of Uncontroverted

Facts” on November 8, 2012. As noted by the Court of Federal Claims, see

Sanchez v. Sec’y of Health & Human Servs., 142 Fed. Cl. 247, 252-53 (2019),

vacated and remanded, 809 F. App’x 843 (Fed. Cir. 2020) (hereinafter “Opinion

and Order”), the description of the facts as “uncontroverted” reflects an imprecise

word choice to which the undersigned contributed. The undersigned had intended

to set forth a process by which the parties would identify the material facts that the

parties genuinely disputed. The undersigned did not expect that the parties would

produce a stipulation about all facts because, after all, the parties’ dispute about the

3

In considering the issues on remand, the undersigned has re-read the transcript from the

2012 hearing as well as notes, which record demeanor-based observations.

6

events in Trystan’s life necessitated the May 15, 2012 hearing. Instead, the parties

would identify the issues requiring resolution.

To some degree, the parties’ Joint Statement was not as helpful as

anticipated, and the undersigned recognizes that the instructions could have been

more detailed. In the absence of more direct guidance, the parties produced

statements such as “According to Jennifer [Ms. Sanchez], between her birthday and

the next time she took him [Trystan] to the doctor nearly two months later in late

April, Trystan lost control of his head.” Joint Statement ¶ 17 (citing Transcript

(“Tr.”) at 78) (emphasis added).4 The parties could easily agree that transcript

page 78 supports the proposition that Ms. Sanchez testified that Trystan lost control

of his head between February and April. However, the words that Ms. Sanchez

spoke during the hearing are not directly material. The more critical question---

and the one about which the parties disagreed---was whether, in fact, Trystan lost

control of his head between February and April. On this specific point, the

undersigned declined to credit Ms. Sanchez’s testimony because the records from a

pediatrician who saw Trystan at the end of April recorded “no neurological

symptoms.” See Ruling Finding Facts, issued Apr. 10, 2013, ¶¶ 13-14 (citing

exhibit 1 at 50-52).

In the Ruling Finding Facts, the undersigned also found that Trystan did not

exhibit arm contortions around February 16-17, 2009. Id. ¶¶ 8-11. The

undersigned reasoned that if Trystan had moved his arm unusually, then the

Sanchezes would have informed the physician’s assistant who saw Trystan on

February 17, 2009, and the physician’s assistant would have memorialized a

complaint in the notes.

On the other hand, the Ruling Finding Facts did credit the witnesses’

testimony that on the night following the February 5, 2009 vaccination, Trystan

cried inconsolably. He also had a lump on his left thigh and a fever. The fever

ebbed and flowed over the next few days. Ruling Finding Facts ¶ 7.

The Ruling Finding Facts directed the parties to provide it to their experts.

If the experts assumed facts that were not consistent with the Ruling Finding Facts,

4

The transcript page numbering runs consecutively across the three hearings in this case

but does contain some gaps in the numbering: fact hearing (pages 1-231), entitlement hearing

(pages 233-1011), and remand hearing (pages 2000-2179).

7

then the expert was unlikely to be persuasive. Id. at 16 (citing Burns v. Sec’y of

Health & Human Servs., 3 F.3d 415, 417 (1993)).

The Sanchezes filed another report from Dr. Steinman on May 22, 2013.

Exhibit 17. However, Dr. Steinman’s report seemed to resemble very closely his

previous report. For example, Dr. Steinman continued to assert that Trystan had

seizures. This prompted an order directing Dr. Steinman to explain the basis for

his opinion that Trystan had seizures. Order, issued June 14, 2013.

Dr. Steinman’s report did not really answer this question. He stated that

Trystan suffered seizures. Exhibit 28 at 2. He also stated that Trystan suffered one

continuous process. Id. at 3. In a December 6, 2013 status conference, the

Secretary questioned how Dr. Steinman linked an apparently isolated seizure with

developmental delay. Thus, the Sanchezes were ordered to file a status report.

The Sanchezes asserted that Trystan had “a process of continuous and/or

intermittent seizure activities commencing in February 2009.” Pet’rs’ Status Rep.,

filed Dec. 18, 2013, at 4. As evidence of these seizures, the Sanchezes pointed to

(1) the inconsolable crying on February 5, 2009; (2) the loud pitched cry and

kicking feet on February 16, 2009; (3) the inconsolable crying during March 2009,

when his parents watched a boxing match; (4) Trystan’s loss of skills by June 1,

2009; (5) inconsolable crying during the August 8, 2009 baby shower; (6) the

observation by Ms. Marin-Tucker on August 17, 2009, that Trystan’s extremities

seemed soft yet rigid; and (7) the development of tremors or twitching between

October 7, 2009, and November 12, 2009. Id. at 2. The Sanchezes also pointed to

the September 17, 2010 EEG that indicated, to the Sanchezes, partial seizures. Id.

at 3 (citing exhibit 1 at 181-82).

The Sanchezes additionally relied upon an August 2, 2010 note from Dr.

Friedman. There, Dr. Friedman recorded a history in which Trystan had “one

particularly bad night” during which “he would stiffen his arms behind his back, he

would jerk his arms and neck . . . Would do this minutes at a time. Dad would try

to straighten his arms but they would snap back. . . . After that night, this would

come and go.” Id. at 2-3 (quoting exhibit 1 at 194). The Sanchezes justified

reliance on Dr. Friedman’s August 2, 2010 record because the Ruling Finding

Facts stated that the parties agreed that records created after the November 12,

2009 visit with Dr. Michelson were accurate.

The parties discussed this status report about Trystan’s seizures in status

conferences held on January 17 and 28, 2014. The Secretary argued that the

Sanchezes’ reliance on the history recorded in Dr. Friedman’s note was “logical

8

insanity” in that it was not consistent with the Ruling Finding Facts. The Secretary

argued that the Sanchezes’ approach would allow them to go to a doctor “today”

and set forth a history about Trystan’s health in 2009.

A January 31, 2014 order attempted to resolve this dispute by distinguishing

between histories and findings in the reports from doctors. The undersigned stated

that:

paragraph 24 of the Findings of Fact was intended to state that

the medical records created after Trystan’s visit with Dr.

Michelson were accurate to the extent that the medical records

described Trystan’s contemporaneous condition. The

Sanchez[es’] account of remote events in Trystan’s life to Dr.

Friedman does not qualify as a contemporaneous record.

Order, issued Jan. 31, 2014. Accordingly, the parties were directed to confirm that

their experts were not relying upon Dr. Friedman’s record for the basis of events in

Trystan’s life between February 2009 through November 2009.

The Secretary responded to Dr. Steinman’s reports by presenting another

report from Dr. Raymond. 5 Dr. Raymond suggested that Trystan might benefit

from genetic testing because Trystan might have a mutation in his mitochondria.

Exhibit E at 2. Dr. Raymond wondered how Dr. Steinman could say that the

vaccinations caused Trystan’s problems when the doctors have been unable to say

what Trystan’s diagnosis is. Id. The Secretary also presented a report from

Edward Cetaruk, a medical toxicologist, who made the same point. Exhibit G at

17. Based, in part, on the criticisms from the Secretary’s experts, the undersigned

began to question whether a reasonable basis supported the claims set forth in the

petition. Order, issued May 13, 2014.

The Sanchezes produced another report from Dr. Steinman. Exhibit 36. In

response to Dr. Raymond’s suggestion that Trystan might have a genetic mutation

5

Although this decision does not mention each report from every expert, the undersigned

has reviewed and considered all reports submitted into evidence. See Moriarty v. Sec’y of

Health & Human Servs., 844 F.3d 1322, 1330 (Fed. Cir. 2016) (noting that the Vaccine Act

requires a special master to consider all relevant medical and scientific evidence of record).

9

affecting his mitochondria, Dr. Steinman offered a hypothetical opinion that

largely has become the Sanchezes’ claim:

[If Trystan had a genetic mutation,] one should remember that

there had been no issues related to this mutation prior to the

vaccines. Consequently, just in parallel with analysis of what

triggers clinical deficits in mitochondrial disorders, it can be

argued that this mutation was significantly aggravated by the

vaccines, which then progressed to a clinical picture with the

subsequent issues. We know that in many metabolic disorders

a stress like vaccination or in the case of organic acidemias a

protein load, will trigger neurologic deficits.

Exhibit 36 at 2. Dr. Steinman repeated this point later in his report, stating that as

an expert, he felt compelled to reexamine the evidence. Based upon the evidence,

Dr. Steinman wrote that “there is a plausible line of reasoning that Trystan Sanchez

had a mitochondrial disorder that was not expressed prior to his vaccinations; and,

his vaccinations significantly aggravated this disorder.” Id. at 11.

In developing this account, Dr. Steinman again presented a chronology of

events in Trystan’s life. In doing so, Dr. Steinman cited an August 7, 2012 report

from Dr. Haas. Dr. Haas recounted that Trystan had “acute onset regression and

dystonia at six months of age, following vaccination, which repeated with the next

set of vaccines at 12 months.” Id. at 13 (quoting exhibit 26 at 3). As will be

discussed later, Trystan’s dystonia (or lack thereof) is a prominent issue on

remand.

Three months before the start of a hearing previously scheduled for

September 10-12, 2014, the Sanchezes requested a continuance for the hearing so

that Trystan could have the whole exome sequencing performed as Dr. Haas

recommended. Pet’rs’ Status Rep., filed June 23, 2014. The Sanchezes hoped that

the sequencing would provide clarity as to Trystan’s illness. Id. Based on the

Sanchezes’ request, the hearing dates were postponed to May 2015. Order, issued

July 8, 2014. The Sanchezes were ordered to file the results of the genetic testing

as soon as they became available. Order, issued July 21, 2014.

The Sanchezes submitted the results from the first set of testing as exhibit 53

and a report from Dr. Haas about those results as exhibit 54. The genetic testing

showed that Trystan had a heterozygous mutation in the SDHA gene, the

c.667delG mutation. Exhibit 53 at 1-2. Dr. Steinman explained:

10

As the test results indicate, developmental regression,

hypotonia, spasticity, dystonia, seizures, high T2 W signal,

basal ganglia abnormalities and periventricular white matter

changes could be associated with an SDHA-related disorder. I

would add IF he were homozygous, he could have a

mitochondrial disease known as Leigh syndrome. However,

currently, the test results do not show that Trystan is

homozygous.

Exhibit 55 at 1. Dr. Steinman noted that Dr. Haas requested additional genetic

testing. Dr. Steinman added, “as indicated in my last supplemental expert report, if

the additional blood testing supports mitochondrial issues such as Leigh’s

syndrome or if Dr. Haas determines that there is a mitochondrial disorder based

upon the clinical findings, my last supplemental opinion, dated May 24, 2014,

addressed such occurrence.” Id.

The Sanchezes filed testing identifying Trystan’s genetic mutations on

January 23, 2015. Exhibit 59. In the ensuing status conference, the Secretary

emphasized that the genetic testing further undermined the reasonable basis for

continuing the case. However, the Sanchezes wanted to press forward. The parties

noted that they needed additional expert reports, although they also decided to

retain the May 2015 hearing date at that time. Order, issued Feb. 4, 2015. On

February 20, 2015, the Sanchezes filed a status report requesting that the May 2015

hearing be postponed. The Secretary did not object to this request. Order, issued

Mar. 3, 2015. Accordingly, the undersigned cancelled the May 2015 hearing and

scheduled a status conference for late April 2015 to discuss the next steps. Id.

During the April 2015 status conference, the undersigned stated a concern

that the newly-filed information regarding Trystan’s genetic mutations undermined

the Sanchezes’ claim of a vaccine injury because Trystan’s clinical course may be

consistent with what is expected based on the mutations alone. Order, issued May

8, 2015, at 1. The parties also discussed how the burden of proof is allocated in

genetics cases with the Sanchezes asking whether they as petitioners have the

burden to show how Trystan would have been but for the vaccination. The

undersigned encouraged the Sanchezes to develop evidence that would show that

Trystan was worse than would be otherwise expected for someone with his genetic

11

mutations. Id.6 Accordingly, the Sanchezes requested additional time to procure

genetic testing from Trystan’s siblings since the results might shed light on how

Trystan’s disease course may be different than what can be expected for someone

with his same genetic mutations. Id. The Sanchezes’ request was granted, and a

status conference was set for June 2015, to discuss the results from the new genetic

testing and the Sanchezes’ next steps. Id. at 1-2.

The Sanchezes stated that the additional genetic testing would not be

complete before the end of July 2015, and that the Sanchezes currently had an

appointment scheduled with their treating physician for late August 2015, to

discuss the results of this additional genetic testing. Pet’rs’ Status Rep, filed June

23, 2015. The undersigned set a status conference for the end of September 2015.

Order, issued June 24, 2015.

During the September 2015 status conference, the Sanchezes contended that

the Federal Circuit’s opinion in Paluck v. Sec’y of Health & Human Servs., 786

F.3d 1373 (Fed. Cir. 2015), helped to support the reasonable basis for their claim

because, in that case, the Federal Circuit concluded that a vaccination can

aggravate a mitochondrial disorder. In addition, the parties discussed the need for

additional expert reports in light of the new information regarding Trystan’s

genetic mutations. Order, issued Oct. 1, 2015.

Over the course of the next year, both the Sanchezes and the Secretary filed

additional reports from their respective experts. The Sanchezes added a new

expert with a specialty in mitochondrial disorders, Dmitriy Niyazov, whose first

report is exhibit 68. Dr. Niyazov opined that Trystan “experienced developmental

regression, caused by a vaccine reaction, which exacerbated his deficient cellular

energy metabolism due to his SDHA gene mutations.” Exhibit 68 at 7. For the

initial manifestation of Trystan’s Leigh’s disease,7 Dr. Niyazov identified the

6

In April 2015, it appeared that the burden of showing how the vaccinee would have

developed “but for” the vaccination fell to petitioners. See Locane v. Sec’y of Health & Human

Servs., 685 F.3d 1375, 1379 (Fed. Cir. 2012).

However, after the Federal Circuit remanded this case, the Federal Circuit declared that

the petitioners do not bear the burden of proof on this point for cases involving genetic disorders.

Sharpe v. Sec’y of Health & Human Servs., 964 F.3d 1072, 1084-85 (Fed. Cir. 2020).

7

Dr. Haas confirmed Trystan’s diagnosis of Leigh’s disease. See exhibit 62 at 5.

12

“inconsolable crying along with the fever” that occurred within 48 hours of the

February 5, 2009 vaccination. Id. at 8. He continued:

This inflammatory response served as the initial catabolic event

in Trystan that triggered a gradual process of developmental

regression and aggravation leading to [Leigh’s syndrome] over

the next several months which has become more evident around

June 1, 2009 (inconsolable crying, hypotonia, arm contortion,

etc.). However developmental regression was slowly

developing ever since the crying and fever took place as the

result of the vaccination . . . .

Id.

Dr. Niyazov also addressed whether the genetic mutations could inform an

assessment of how Trystan would have developed but for the vaccinations. He

opined that due to “variable expressivity” and “incomplete penetrance,” Trystan

may not have developed Leigh’s syndrome at all. Id. at 10. Dr. Niyazov heavily

relied upon the Levitas article to support his opinion. Id.; see Aviva Levitas et al.,

Familial neonatal isolated cardiomyopathy caused by a mutation in the

flavoprotein subunit of succinate dehydrogenase, 18 Eur. J. Hum. Genetics 1160

(2010), filed as exhibit 79.

Dr. Steinman’s report roughly presented the same view as taken by Dr.

Niyazov in his report. Dr. Steinman’s conclusion was “if not for the vaccinations

on Feb. 5, 2009, Trystan Sanchez would not be suffering from Leigh’s disease.”

Exhibit 95 at 1. Much of Dr. Steinman’s December 10, 2015 report repeats

information presented in his previous reports, reflecting Dr. Steinman’s intention

to present a comprehensive report. For example, Dr. Steinman referenced his

September 13, 2013 report (exhibit 28) in which he stated Trystan began to have

seizures on February 16, 2009, when he was running a fever, having difficulty

breathing, crying with a loud-pitched cry, jerking around, and startling awake. Id.

at 28 (citing Ruling Finding Facts ¶ 8). Like his earlier report, Dr. Steinman again

stated that Dr. Haas’s August 7, 2012 report provided detail about Trystan’s

condition on February 16, 2009. Dr. Steinman reproduced the report in which Dr.

Haas stated, in part, “11 days after the vaccination, [Trystan] had an episode of

‘contortion’ in the upper limbs.” Id. at 39 (reproducing exhibit 26 at 1). Similarly,

Dr. Steinman cited a report from Dr. Haas that describes Trystan as having “acute

regression associated with significant dystonia at 6 months of age following

vaccination. He subsequently had a second episode of developmental regression

13

12 months later.” Id. at 16 (citing exhibit 54 at 1-2).8 Although Dr. Steinman

recognized that Dr. Haas described Trystan as having dystonia following his six-

month vaccinations; that Dr. Friedman noted Trystan had dystonia on August 2,

2010 (exhibit 95 at 11, relying upon exhibit 1 at 198); and that Trystan’s genetic

mutations are associated with dystonia (exhibit 95 at 14, relying upon exhibit 53 at

1-4), Dr. Steinman did not suggest that Trystan suffered dystonia on February 16,

2009.

In response to these two reports and to address the genetic testing, the

Secretary obtained a report from Dr. Raymond. Dr. Raymond concluded that

Trystan is “a child with Leigh syndrome secondary to mutations in the gene

SDHA. This is the sole cause of his neurologic condition and the onset was not

caused by immunizations received and his disease course is consistent with the

condition and was not aggravated by the receipt of vaccination.” Exhibit H at 8.

The primary basis for Dr. Raymond’s opinion was that Trystan’s case matched a

case reported by Parfait in that both Trystan and the Parfait subject had a

compound heterozygous mutation. Id. at 3.

The parties then obtained additional reports from the experts. Essentially,

these reports reinforced the themes from the previous reports. Dr. Niyazov

asserted that mutations can present differently, benignly or pathogenically, and

relied upon Levitas. See exhibit 102. In contrast, Dr. Raymond relied upon Parfait

as a report involving a child very similar to Trystan and the reports that companies

that produce genetic reports characterize Trystan’s mutations as pathogenic. See

exhibit P.

After the parties finished the submission of expert reports, they filed briefs.

The Sanchezes filed their brief on July 7, 2017. The Secretary responded on

September 1, 2017.

In the pre-hearing status conference, the undersigned defined the amount of

time the parties had to elicit testimony from their own witnesses on direct

examination, or from the other party’s witness on cross-examination. See order,

issued Nov. 27, 2017, at 3.

8

While Dr. Steinman accurately cites Dr. Haas’s November 11, 2014 report as saying

that Trystan had dystonia at 6 months of age (exhibit 54 at 1-2), Dr. Haas has carried this history

forward from his first report. See exhibit 26 at 3.

14

A four-day hearing was held on December 4-7, 2017. During the hearing,

the Sanchezes solicited testimony from their two expert witnesses: Dr. Steinman

and Dr. Niyazov. The Secretary solicited testimony from four expert witnesses:

Dr. Raymond, Dr. Stephen McGeady, Dr. Cetaruk, and Professor Dean Jones. The

hearing ended half a day early, with both parties and the undersigned not using all

their allotted time. Among other issues, the evidence concerning Trystan’s arm

contortions and possible dystonia were discussed at the hearing. Specifically, Dr.

Steinman characterized Trystan’s “arm contortions” occurring after the vaccination

when he was six-months old as dystonia. Tr. 357 (“dystonic posturing of his

arm”). He further discussed what he believes was Trystan’s dystonia as being part

of the typical progression of Leigh’s syndrome. Tr. 354. On this basis, Dr.

Steinman concluded that the presence of dystonia during this time “added weight”

to evidence showing that the vaccination was a causal “environmental trigger” of

Trystan’s development of Leigh’s syndrome. Tr. 358. Furthermore, he viewed

what he characterized as the dystonic posturing of Trystan’s arm as an indicator of

a seizure occurring at this time. Tr. 357.

The undersigned found that the Sanchezes were not entitled to compensation

in a decision issued on October 9, 2018. The decision began with a statement of

facts from Trystan’s life. In doing so, the decision attempted to summarize the

April 10, 2013 Ruling Finding Facts. For example, the decision explained that the

undersigned had found notations in medical records created contemporaneously

more persuasive than testimony provided later.

However, in a critical aspect, the October 9, 2018 decision deviated from the

April 10, 2013 Ruling Finding Facts. The Ruling Finding Facts stated that around

February 17, 2009, “Trystan did not begin to exhibit arm contortions.” Ruling

Finding Facts ¶ 11. However, the October 9, 2018 decision stated that around

February 15, 2009, Trystan’s “arms contorted and he was jerking around.

However, these movements were of the type typically displayed by an infant

suffering from a cold.” Sanchez v. Sec’y of Health & Human Servs., No. 11-

685V, 2018 WL 5856556, at *4 (Fed. Cl. Spec. Mstr. 2018), mot. for rev. denied,

142 Fed. Cl. 247, 252-53 (2019), vacated and remanded, 809 F. App’x 843 (Fed.

Cir. 2020) (hereinafter “Decision”). The October 9, 2018 decision did not explain

this inconsistency.

The October 9, 2018 decision also modified the April 10, 2013 Ruling

Finding Facts in one other way, although this change is less important. The April

10, 2013 Ruling stated that Trystan began to lose milestones between May 17,

2009, to June 17, 2009, and specified the mid-point of this range (June 1, 2009).

15

Ruling Finding Facts ¶¶ 18, 20. However, in the December 2017 hearing, the

Sanchezes brought forward evidence suggesting that parents might not

immediately detect the loss of a child’s milestones. Tr. 438-39. Therefore, the

October 9, 2018 adjusted the loss of milestones to “the beginning of May 2009, at

the earliest.” Decision at 8, 2018 WL 5856556, at *4.

After completing a statement of facts about Trystan’s life, the decision set

out the procedural history, the standards for adjudication, and an overview about

genetics (Sections II-IV). The Analysis section (section V) was divided into three

parts. In part A, the undersigned found that the Sanchezes showed that a

vaccination could aggravate an underlying mitochondrial disorder. In part B, the

undersigned found that the Sanchezes did not establish that the vaccinations

affected Trystan’s mitochondrial disorder for two reasons. First, the manifestation

of neurologic delay, which was no earlier than May 1, 2009, occurred too long

after the February 5, 2009 vaccination. Second, during the interim, Trystan

experienced infections that could have caused his metabolic decompensation. In

part C, the undersigned reviewed the genetic evidence, the arguments from Dr.

Niyazov about Levitas, and the arguments from Dr. Raymond about Parfait. The

conclusion was that “the Secretary provided persuasive evidence to show that

Trystan’s mutations were expected to cause serious mitochondrial disease . . . [and]

that Trystan’s actual course is entirely consistent with what is known about his

genetic mutations.” Decision at 40-41, 2018 WL 5856556, at *25.

B. Court of Federal Claims

The Sanchezes disagreed with the decision by filing a motion for review on

November 8, 2018. In their motion for review, the Sanchezes argued that the

undersigned committed reversible error for three reasons. First, the Sanchezes

argued that the undersigned failed to draw reasonable inferences regarding the

timing of Trystan’s symptoms, and erroneously did not credit the Sanchezes’ oral

testimony or reports to various medical providers regarding changes in Trystan’s

condition following vaccination. The Sanchezes also highlighted the

undersigned’s acknowledgement of Trystan’s arm contortions in February 2009

following the vaccination and argued that the conclusion that these were consistent

with a cold (and not necessarily neurological decline) was also in error. Second,

the Sanchezes argued that the undersigned disregarded the Federal Circuit’s

findings in Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373 (Fed. Cir.

2015), or alternatively disregarded evidence regarding the acceptable timing for the

onset of neurodegeneration. Finally, the Sanchezes argued that the undersigned

erroneously disregarded evidence of challenge-rechallenge.

16

In a response filed on December 7, 2018, the Secretary first argued that the

undersigned’s findings regarding the onset of loss of skills were supported by

reasonable inferences because: (1) deeming the earlier, rather than later, medical

records as comparatively more persuasive was not arbitrary or capricious; (2) the

undersigned’s determination that Trystan’s February 2009 symptoms were

consistent with a cold was supported by the record; and (3) the 2009 calendar

entries used by petitioners to support their claim are unreliable. Second, the

Secretary argued that the undersigned properly found that Trystan’s

neurodegeneration did not occur within a medically acceptable time frame

sufficient to infer causation. The Secretary argues this primarily because Trystan’s

first clear sign of neurodegeneration (loss of skills) occurred months after

vaccination, and the assertion that other earlier behavior, such as inconsolable

crying, indicate neurodegeneration that ebbed and flowed following the

vaccination was merely speculative. Finally, the Secretary argued that petitioners’

reliance on Paluck is misplaced because, unlike in that case, the undersigned did

not set a “hard and fast” time constraint for the onset of neurodegeneration and

instead properly weighed evidence regarding the timing of Trystan’s indicator of

neurodegeneration (skill loss) and whether this supported an inference of

causation.

Judge Campbell-Smith issued an opinion denying the motion for review on

February 11, 2019. In so doing, the Court found that the undersigned did not err in

giving little weight to or emphasis on the day planner evidence, given that

petitioners did not provide arguments as to the relevance of this evidence, and that

the differences in recitations of facts that petitioners argued against were the result

of the undersigned giving greater weight to contemporaneous medical records than

petitioners’ testimony.

With respect to the causation analysis, the Court identified five key issues

raised by petitioners: (1) challenge-rechallenge; (2) findings regarding onset of

neurodegeneration; (3) effect of the Paluck II decision; (4) evidence of colds and

infections and petitioners’ failure to address the alternate cause issue; and (5) the

undersigned’s consideration of evidence of arm contortions. First, the Court found

that though the challenge-rechallenge issue was not mentioned in the

undersigned’s decision, he need not address all of petitioners’ arguments and he

had already found that the relevant symptoms had not occurred, making the

challenge-rechallenge argument moot. Second, the finding regarding onset of

neurodegeneration was not arbitrary or capricious. Third, the evidentiary record in

this case was substantially different than that of Paluck II; thus, Paluck II did not

dictate a finding of entitlement in this case. Additionally, the undersigned did not

17

use the temporal measure rejected in Paluck II and did not err in his evaluation of

the expert testimony under Paluck II. Fourth, the undersigned did not err in

finding that petitioners’ arguments regarding colds and infections as an alternate

cause were inadequate. Fifth and finally, though the undersigned changed his

finding between the Ruling Finding Facts and entitlement decision regarding the

occurrence of arm contortions, he maintained that these arm contortions did not

indicate of a neurological condition or cause. Thus, the motion for review was

denied and judgment entered.

C. Federal Circuit

The Sanchezes filed their notice of appeal to the Federal Circuit on April 9,

2019. In their appellate brief, filed on May 24, 2019, the Sanchezes argued: (1)

that the undersigned failed to consider the totality of the record, including Dr.

Niyazov’s expert testimony, regarding the onset of neurodegeneration adequately,

and that Judge Campbell-Smith failed to examine all the evidence in determining

whether the undersigned committed legal error on this point; (2) that the

undersigned erroneously failed to address evidence of challenge-rechallenge; and

(3) that Paluck dictated a finding of entitlement in this case.

In response, the Secretary argued first, that petitioners’ arguments amounted

to asking the Federal Circuit to reweigh evidence and that the undersigned

correctly found (1) that petitioners did not establish by preponderant evidence that

three months was a medically acceptable time frame for onset, and (2) the

undersigned’s conclusion that Trystan’s first manifestation of Leigh’s syndrome

was his loss of skills three months post-vaccination was reasonable. Second, the

Secretary argued that there was no evidence of challenge-rechallenge in this case.

Finally, the Secretary argued that the evidentiary record in this case is substantially

different from Paluck, making petitioners’ reliance on that case misplaced.

After holding oral arguments, the Federal Circuit issued its opinion on April

7, 2020, remanding the case for reconsideration on multiple issues. As a

preliminary issue, the Federal Circuit ruled that the differences between the

evidentiary records of this case and Paluck are substantial enough “such that the

outcome of this case is not dictated by Paluck.” Sanchez v. Sec’y of Health &

Human Servs., 809 F. App’x 843, 852 (Fed. Cir. 2020). Thus, on that question, the

Federal Circuit rejected the Sanchezes’ arguments.

However, for other issues, the Federal Circuit was more receptive to the

Sanchezes’ contentions. The Federal Circuit first identified a “significant”

discrepancy between the undersigned’s Ruling Finding Facts and recitation of facts

18

in Decision regarding the presence of arm contortions in February 2009. Id. at

852-53. Specifically, the Court stated:

Importantly, because of the change in the findings made with

respect to the arm contortions, the special master’s finding that

Trystan’s behavior on the night of February 16 was consistent

with a cold is not supported by expert testimony that

specifically addressed the arm contortions. Because this issue

is of central importance to the causation analysis, it is necessary

to remand for further consideration of the causation issue in

light of the special master’s findings in 2018 regarding

Trystan’s arm contortions.

Id. at 853.

Second, the Federal Circuit directed the undersigned to revisit his analysis of

Althen prongs 2 and 3, specifically “whether there was a logical sequence of cause

and effect linking Trystan’s vaccinations and his injuries as well as a proximate

temporal relationship between the vaccinations and the onset of injuries” and

“whether Trystan’s infections between February and May of 2009 caused the

manifestation of his Leigh’s syndrome, independent of his vaccinations.” Id. The

Federal Circuit noted that the undersigned “treated [Althen prongs 2 and 3]

together as being directed to the single issue of causation,” but specified that the

undersigned should make explicit findings with respect to each of these

considerations separately on remand. Id. In the event that the undersigned finds

that the Sanchezes have made out a prima facie case, he should then address

whether Trystan’s post-vaccination infections triggered the manifestation of his

Leigh’s syndrome, independent of the vaccinations. Id. at 853-54.

Third, the Federal Circuit found that the undersigned had not “implicitly

rejected” the challenge-rechallenge argument in his decision and that “the special

master should address that theory expressly on remand.” Id. at 854. The Federal

Circuit specified that the factual findings upon which the entitlement decision was

based pre-dated expert testimony, much of which asserted challenge-rechallenge.

Additionally, the Federal Circuit noted that the two medical reports from Ms.

Marin-Tucker, upon which the undersigned relied in coming to his factual

conclusion that Trystan did not suffer additional loss of skills following his August

2009 vaccinations, may suggest slight differences or increases with respect to loss

of skills. Id.; see Ruling Finding Facts at 15 n.11 (finding against additional

neurological symptoms following Trystan’s August 2009 vaccinations based on

19

Ms. Marin-Tucker’s reports of the Sanchezes denying “any new complaints” but

reporting “no improvement either” at Trystan’s October 2009 appointment) (citing

exhibit 1 at 57). The Federal Circuit directed the undersigned to explicitly address

challenge-rechallenge in light of these medical reports. Id.

Finally, the Federal Circuit invited further consideration of medical evidence

or literature relevant to whether, because of Trystan’s genetic mutations, “the

timing and severity of his Leigh’s syndrome would have been the same, regardless

of the effect of the vaccinations.” Id. The Federal Circuit noted that this issue was

left open at the end of the entitlement decision and that, given how much time has

passed since the decision was issued and the ever-evolving nature of genetics

research, the undersigned may wish to consider additional evidence related to this

aspect of the case. Id.

D. Office of Special Masters on Remand

When the case returned to the Office of Special Masters, the parties through

their attorneys and expert witnesses worked quickly. After the mandate from the

Federal Circuit issued, the undersigned proposed a schedule that allowed for the

submission of supplemental reports in advance of a hearing. Orders, issued June 3,

2020 and June 12, 2020. As part of this proposed schedule, the undersigned also

ordered the Sanchezes to file a status report answering certain questions regarding

updates on Trystan’s status, including updated medical records and Trystan’s

Individualized Education Plan, and indicating whether they anticipated filing

supplemental expert reports. Order, issued June 3, 2020. The undersigned ordered

the Secretary to submit a status report indicating whether he anticipated filing a

supplemental expert report. Id. The Sanchezes and the Secretary filed their status

reports on June 8, 2020, and June 10, 2020, respectively. They both indicated an

intention to file supplemental expert reports and agreed to the undersigned’s

proposed pre-hearing schedule. The Sanchezes also filed additional updated

medical records and Trystan’s Individualized Education Plan.

The Sanchezes submitted initial expert reports from Dr. Steinman (exhibit

185) and Dr. Niyazov (exhibit 189), and the Secretary submitted an initial expert

report from Dr. Raymond (exhibit P). They also submitted responsive reports.

Exhibits 195, 196, and Q.

A prehearing status conference was held on July 7, 2020, to discuss

proceedings for the hearing. In this status conference, the undersigned asked the

attorneys whether the undersigned might ask questions of the expert witnesses

first, followed by each party’s questioning. Both attorneys agreed to this process.

20

In hearings, special masters are permitted to be inquisitorial. See Doe v. Sec’y of

Health & Human Servs., 76 Fed. Cl. 328, 334 (2007) (commenting on the “active

role of the Special Master in questioning witnesses”); Hines v. Sec’y of Health &

Human Servs., 21 Cl. Ct. 634, 648 (1990), aff’d, 940 F.2d 1518 (Fed. Cir. 1991)

(“The Special Master is not required to be a ‘potted plant’ at the hearing . . .

Rather, the legislative history of the newly-amended Vaccine Act emphasizes that

‘[t]he system is intended to allow the proceedings to be conducted in an

“inquisitorial” format’. . . .” (quoting 135 Cong. Rec. H9476 (daily ed. Nov. 21,

1989))).

A hearing was held on July 9, 2020, during which the experts testified

remotely via videoconferencing. Though the undersigned set aside two days for

the hearing, the parties confirmed that they had no further questions for witnesses

at the conclusion of the first day, and the hearing ultimately only lasted for one

day.

After the hearing, on July 10, 2020, the undersigned issued an order for post-

hearing briefs, which outlined various procedural and substantive questions for the

parties to address. These questions were tailored to address the remand issues

presented by the Federal Circuit and specific items of relevance that arose as part

of the experts’ testimony at the hearing. On an expedited schedule, the parties

submitted two rounds of briefs simultaneously. The parties submitted their first

briefs on July 29, 2020, and they submitted their reply briefs on August 5, 2020.

Along with their initial post-hearing brief, the Sanchezes submitted additional

medical literature aimed at addressing certain points in the undersigned’s briefing

order. The Secretary did not object to this additional medical literature submitted

after the official closing of the evidentiary record. Resp’t’s Status Rep., filed July

31, 2020. With the parties’ briefs and reply briefs submitted, the case is again

ready for adjudication.

III. Qualifications of Experts

The adjudication begins with a review of the qualifications of the six people

whom the parties have advanced as experts. Because the Sanchezes advance the

backgrounds of their experts to support their claim (see, e.g., Pet’rs’ Remand Br. at

12) and because special masters may consider the background of a person offering

opinion testimony, the qualifications are set forth below. As part of the review, the

undersigned also has attempted to search for commentary about each person’s past

testimony even-handedly. See Greene v. Sec’y of Health & Human Servs., 146

Fed. Cl. 655 (2020) (noting that a failure to consider the (lack of) expertise for the

21

Secretary’s experts in the context of considering the (lack of) expertise for the

petitioner’s experts was arbitrary and capricious).

A. The Sanchezes’ Experts

Initially, the Sanchezes relied upon Dr. Steinman. After Trystan’s Leigh’s

syndrome was diagnosed, they added a second expert, Dr. Niyazov.

1. Lawrence Steinman

Dr. Steinman has often been retained by petitioners and special masters have

become accustomed to reviewing his opinions. Dr. Steinman graduated from the

medical school at Harvard University. He was a resident in pediatrics at Stanford

University Hospital in 1974. He had fellowships from 1975-77, including one at

the National Institutes of Health. In 1977-80, he was a resident in pediatric and

adult neurology at the Stanford University Hospital. Beginning in 1980, Dr.

Steinman served in various academic roles, primarily at Stanford University. From

2002 to 2011, he chaired the Stanford University program in immunology. From

2008 to the present, he was the incumbent of the George A. Zimmerman Chair as

professor of neurological sciences, neurology, and pediatrics. Exhibit 168 (Dr.

Steinman’s curriculum vitae). He became board-certified in neurology in 1984.

Dr. Steinman’s research has focused on multiple sclerosis. The National

Multiple Sclerosis Society and the American Academy of Neurology awarded him

the John M. Dystel prize for outstanding contributions in multiple sclerosis

research in 2004. Seven years later, the International Federation of Multiple

Sclerosis Societies awarded him the Charcot Prize for lifetime achievement in

multiple sclerosis research. Many of the more than 500 articles Dr. Steinman has

written or co-written concern how the immune system may cause demyelinating

diseases such as multiple sclerosis. See exhibit 168, passim.

While much of Dr. Steinman’s career has focused on multiple sclerosis, his

earlier work involved subjects much closer to the issues involved in the pending

case. Dr. Steinman researched the pertussis vaccine and obtained one or two

patents related to the pertussis vaccine. Tr. 244-25. Dr. Steinman also discovered

a mitochondrial disease. Tr. 247.

Other special masters have noted that, as Dr. Steinman’s research and

administrative responsibilities have increased, Dr. Steinman’s participation in

patient care has decreased. E.g., Rolshoven v. Sec’y of Health & Human Servs.,

No. 14-439V, 2018 WL 1124737, at *6 (Fed. Cl. Spec. Mstr. Jan. 11, 2018)

22

(indicating that Dr. Steinman sees 10-20 patients per month); Blackburn v. Sec’y

of Health & Human Servs., No. 10-410V, 2015 WL 425935, at *7 (Fed. Cl. Spec.

Mstr. Jan. 9, 2015) (stating that, due to a focus on research, Dr. Steinman has seen

“considerably fewer patients in the last five years than he saw earlier in his career”

and “[d]uring the last five years, has only seen patients approximately one month

out of the year”); see also Tr. 2055 (Dr. Steinman: “my different responsibilities

have varied with the decade and my other activities”).

In their briefing, the Sanchezes advance Dr. Steinman as an expert in

pediatrics. See Pet’rs’ Remand Br. at 12. While Dr. Steinman is the incumbent of

the George A. Zimmerman chair as a professor of neurological sciences,

neurology, and pediatrics, the depth of Dr. Steinman’s experience in pediatrics,

especially with infants, is not especially clear. For example, in the December 2017

hearing, the Sanchezes brought out direct testimony from Dr. Steinman about his

qualifications in neurology and immunology. The Sanchezes offered “Dr.

Steinman as an expert in neurology and immunology,” and he was recognized as

an expert in those two fields. Tr. 250. The Sanchezes did not develop any

information about Dr. Steinman’s background in pediatrics and the Sanchezes did

not offer Dr. Steinman as an expert in pediatrics. In the remand hearing, Dr.

Steinman stated that he has cared for approximately 100 infants in the last year and

sees about six mitochondrial cases per year. Tr. 2014-15. On redirect

examination, the Sanchezes elicited vague testimony about Dr. Steinman’s work in

pediatrics. See Tr. 2056.

With respect to Dr. Steinman’s opinions in the field of pediatrics, especially

for infants, the undersigned has less confidence in them. One reason is that Dr.

Steinman seems to have relatively less direct experience in caring for infants. For

example, Dr. Steinman never became board-certified in pediatrics. Tr. 2014.

When Dr. Steinman was asked about developmental milestones at various months,

he did not answer with much specificity and his demeanor suggested that he could

not answer this question spontaneously. Tr. 2016, 2052-54. Nevertheless, the

undersigned is not rejecting any of Dr. Steinman’s opinions wholesale. The

undersigned merely notes that Dr. Steinman appears to have relatively less

experience with infants than in other areas, such as multiple sclerosis.

Another reason for some skepticism about Dr. Steinman’s opinions is a

concern about the way Dr. Steinman has acted as an expert witness. Special

masters have indicated that Dr. Steinman presents opinions as an advocate for the

petitioners who retain him. See, e.g., D.G. v. Sec’y of Health & Human Servs.,

No. 11-577V, 2019 WL 2511769, at *182 (Fed. Cl. Spec. Mstr. May 24, 2019);

23

Chinea v. Sec’y of Health & Human Servs., No. 15-095V, 2019 WL 1873322, at

*19 (Fed. Cl. Spec. Mstr. Mar. 15, 2019), mot. for rev. denied, 144 Fed. Cl. 378

(2019); Mueller v. Sec’y of Health & Human Servs., No. 06-775V, 2011 WL

1467938, at *19 n.19 (Fed. Cl. Spec. Mstr. Mar. 16, 2011). This observation, too,

does not force an automatic rejection of everything that Dr. Steinman says.

However, the frequency with which special masters have commented on Dr.

Steinman’s performance as an expert witness prompts the undersigned to take Dr.

Steinman’s opinion with, perhaps, an extra grain of salt.

2. Dmitriy Niyazov

While special masters are quite familiar with Dr. Steinman, Dr. Niyazov is

new to the Vaccine Program. Tr. 374, 389-90 (describing previous experience in

one case or two cases with vaccines). Dr. Niyazov graduated with a distinction in

research from the school of medicine for the University of Rochester in 2001. In

the next two years, he had an internship and residency in surgery at Emory

University School of Medicine. But, he found he did not like that specialty and

changed to medical genetics, in which he was a resident from 2005 to 2007.

Exhibit 167 (Dr. Niyazov’s curriculum vitae); Tr. 374-75.

Beginning in January 2008, he has worked in New Orleans, Louisiana, for

the Ochsner Health System as the section head for medical genetics in the

department of pediatrics. Exhibit 167. He has also been an instructor for the

Tulane University School of Medicine. Id.

Dr. Niyazov focuses on treating mitochondrial disorders. He participates in

various organizations and panels about mitochondrial disorders. Tr. 376, 384-85.

In December 2017, Dr. Niyazov was treating approximately 16 cases with

confirmed Leigh’s syndrome and another 25 patients with suspected Leigh’s

syndrome. Id. 387. Some of these patients live in other countries and have seen

on-line presentations. Dr. Niyazov believes that exercise, nutrition, and vitamins

can help treat mitochondrial diseases, although the Food and Drug Administration

has not approved any of these treatments. Id. 388. Some of Dr. Niyazov’s

approximately three dozen publications concern mitochondrial disease. See

exhibit 167 at 2-6.

In the December 2017 hearing, the Sanchezes offered Dr. Niyazov as an

expert in the field of genetics, including mitochondrial disorders, and he was

accepted without objection. The Sanchezes did not offer Dr. Niyazov as an expert

in the field of pediatrics. Tr. 391.

24

In the hearing on remand, Dr. Niyazov acknowledged that he is not board-

certified in pediatrics. Id. 2064. However, in the last five years, Dr. Niyazov has

seen at least 1,000 infants, although not all those children suffered from

mitochondrial disease. While Dr. Niyazov works with developmental

pediatricians, he was generally familiar with developmental milestones during the

first year. Id.

Dr. Niyazov’s demeanor suggested that he expressed his opinions sincerely

in the sense that Dr. Niyazov honestly believed what he was saying. His opinions

regarding genetics, with some exceptions noted below, were grounded in peer-

reviewed articles.

When Dr. Niyazov strayed from the fields of genetics and mitochondrial

disorders, his opinions were shakier. For example, although Dr. Niyazov opined

about oxidative stress, Dr. Niyazov has relatively little experience in that field.

See id. 548-49.9

Dr. Niyazov has limited experience testifying in the context of the Vaccine

Program. However, in the few cases he has been a part of, other special masters

have indicated that while his testimony has been credible overall, it has suffered

from some inconsistencies. Specifically, one special master stated that he has

“waffled” somewhat in his testimony and that his “testimony about the reliability

of his records . . . was somewhat inconsistent.” Reddy v. Sec’y of Health &

Human Servs., No. 13-208V, 2015 WL 5578610, at *17, *20 (Fed. Cl. Spec. Mstr.

Aug. 26, 2015). Additionally, another special master mentioned some concern

with Dr. Niyazov over either not properly supporting contentions with relevant

research literature or overstating the significance of certain studies in coming to his

conclusions. See Reed v. Sec’y of Health & Human Servs., No. 08-650V, 2018

WL 6844458, at *66, *87 (Fed. Cl. Spec. Mstr. Dec. 4, 2018).

B. Secretary’s Experts

In the December 2017 hearing, the Secretary presented opinion testimony

from four people. On remand, the Secretary relies primarily on Dr. Raymond. To

9

Dr. Niyazov’s relative weakness in the field of oxidative stress (especially when

compared to the experience of Dean Jones) did not affect the outcome of the Sanchezes’ case.

The undersigned determined that the Sanchezes could meet their burden regarding Althen prong

1 without establishing the persuasiveness of the oxidative stress theory. Decision at 19-21, 2018

WL 5856556, at *11-12.

25

a lesser extent, the Secretary also relies upon Dr. McGeady. Thus, their

qualifications are reviewed more thoroughly. For the remaining two experts, Dr.

Cetaruk and Dean Jones, the review can be more summary because their opinions

do not meaningfully affect the issues on remand.

1. Gerald Raymond

Dr. Raymond graduated from the University of Connecticut School of

Medicine in 1984. He was first an intern and then a resident in pediatrics at Johns

Hopkins Hospital from 1984 to 1986. He then had another residency in neurology

and fellowship in developmental neuropathology. His final fellowship, which was

from 1990 to 1993, was in genetics and tetralogy at Massachusetts General

Hospital. Exhibit M (Dr. Raymond’s curriculum vitae).

From 1993 to 2012, Dr. Raymond worked as a pediatric neurologist for the

Kennedy Krieger Institute in Baltimore, Maryland. Through this time, he held

academic posts in neurology at the Johns Hopkins University School of Medicine,

culminating in a tenured position as a professor of neurology. Next, Dr. Raymond

became a professor in neurology with tenure at the University of Minnesota School

of Medicine for approximately five years. Then, starting in 2017, he became a

professor in pediatrics and neurology at the Penn State College of Medicine.

Exhibit M at 2; Tr. 779-80.

Dr. Raymond holds board certifications in clinical genetics and in neurology

with a special competence in pediatric neurology. According to Dr. Raymond,

approximately 12-20 people hold dual certifications in genetics and neurology.

From this group, Dr. Raymond mentored 6-10 people. Tr. 785.

In December 2017, Dr. Raymond was spending approximately 60 percent of

his time in clinical duties with the remainder of his time being research and

administration. Tr. 783. Dr. Raymond estimated that he sees approximately 18-20

patients per week. Tr. 781. His patients include children and adults. Tr. 782. In

his previous positions, Dr. Raymond saw six or seven cases of genetically

confirmed Leigh’s syndrome. He also saw other cases in which the disease was

suspected but not confirmed. Tr. 788. At the December 2017 hearing, Dr.

Raymond was no longer following these patients with Leigh’s syndrome. Tr. 787,

844.

Dr. Raymond focuses his research on adrenoleukodystrophies, which are

disorders of the brain’s white matter. Tr. 782, 842. Dr. Raymond has not

26

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

842.

Dr. Raymond held a board certification in pediatrics from 1991-2005.

Exhibit M at 16. He let that certification lapse. Tr. 845, 2114.

Dr. Raymond was offered as an expert in the field of neurogenetics and

pediatric neurology. He was accepted without objection. Tr. 789.

Like Dr. Niyazov, Dr. Raymond appeared to offer sincerely held opinions.

In the field of genetics, Dr. Raymond’s opinions consistently aligned with

publications that appeared in peer-reviewed journals. Dr. Raymond avoided

offering opinions in fields in which he is not qualified.

The consistency between Dr. Raymond’s opinions and the statements found

in peer-reviewed literature left the impression that Dr. Raymond was expressing

opinions about Trystan’s case as he believed them. Although on cross-

examination, Dr. Raymond acknowledged that he usually reviews three cases per

year for the respondent in Vaccine Program cases, Tr. 845, Dr. Raymond did not

appear to be providing testimony simply to advance the Secretary’s position.

In previous cases, special masters have considered Dr. Raymond thorough in

his review of a petitioner’s medical records and in providing ample support

through medical literature in composing his reports. Specifically, Dr. Raymond

discusses a petitioner’s pre-vaccination medical history in detail during his

testimony, incorporating it into his opinion. L.M. v. Sec’y of Health & Human

Servs., No. 14-714V, 2019 WL 4072130, at *14 (Fed. Cl. Spec. Mstr. July 23,

2019). Dr. Raymond closely evaluates cited medical literature. See Oliver v.

Sec’y of Health & Human Servs., No. 10-394V, 2017 WL 747846, at *27 (Fed. Cl.

Spec. Mstr. Feb. 1, 2017), mot. for rev. denied, 133 Fed. Cl. 341 (2017), aff’d, 900

F.3d 1357 (Fed. Cir. 2018), reh’g and reh’g en banc denied, 911 F.3d 1381 (Fed.

Cir. 2019). In past cases with the undersigned, he has also cogently explained

relevant medical concepts, making his testimony and opinions credible. See, e.g.,

Santini v. Sec’y of Health & Human Servs., No. 06-725V, 2014 WL 7891507, at

*1 (Fed. Cl. Spec. Mstr. Dec. 15, 2014), mot. for rev. denied, 122 Fed. Cl. 102

(2015).

2. Stephen J. McGeady

Dr. McGeady received his medical degree from Creighton University in

1967. He was a resident in pediatrics from 1970 to 1972. His fellowship was in

27

psychiatry / allergy from 1972 to 1974. Beginning in 1974, he served in various

academic positions at institutions in Philadelphia, Pennsylvania. From 1996 to

2007, Dr. McGeady was the chief of the allergy, asthma and immunology division

for duPont Hospital for Children in Wilmington, Delaware. Exhibit N (Dr.

McGeady’s curriculum vitae). He became board-certified in pediatrics in 1973.

He added a second board, allergy and immunology, in 1975. Tr. 728.

By the December 2017 hearing, Dr. McGeady had attained emeritus status,

meaning he was working 1 ½ days per week. Tr. 737. In Dr. McGeady’s career,

he had seen some children with Leigh’s syndrome but maybe not any after 1995.

Tr. 738-39.

Other special masters have regarded Dr. McGeady as well-prepared, logical,

and understandable in his testimony. Specifically, he has incorporated an

extensive knowledge of the record during his testimony. Doe/17 v. Sec’y of

Health & Human Servs., No. [redacted]V, 2008 WL 2541188, at *7 (Fed. Cl. Spec.

Mstr. May 30, 2008), mot. for rev. denied, 84 Fed. Cl. 691 (2008). Furthermore,

he is thought to present his testimony in a way that is logical and can answer

questions thoroughly and defend his positions. See Hirmiz v. Sec’y of Health &

Human Servs., No. 06-371V, 2014 WL 4638375, at *10 (Fed Cl. Spec. Mstr. Aug.

26, 2014) (“Dr. McGeady was better able to answer questions and defend his

opinion.”), mot. for rev. denied, 119 Fed. Cl. 209 (2014), aff’d, 618 F. App’x 1033

(Fed. Cir. 2015). Finally, the undersigned has regarded Dr. McGeady in the past as

“explain[ing] the basis of his opinions in an understandable way.” Jaafar v. Sec’y

of Health & Human Servs., No. 15-267V, 2018 WL 4519066, at *3 (Fed. Cl. Spec.

Mstr. Aug. 10, 2018).

3. Edward Cetaruk

Dr. Cetaruk obtained a medical degree from the New York University

School of Medicine in 1991. He became a fellow of the American College of

Medical Toxicology in 2009. Exhibit O (Dr. Cetaruk’s curriculum vitae).

The focus of Dr. Cetaruk’s work in this case was to respond to Dr.

Steinman’s theories of causation, especially the theory that alum can harm the

recipient of a vaccine. See Tr. 593. Because the details of Dr. Steinman’s alum

theory are not an issue on remand, it is not necessary to evaluate the depths of Dr.

Cetaruk’s background.

Other special masters have commented on Dr. Cetaruk’s detail-oriented

approach to his reports and testimony. Specifically, in addition to providing

28

“much greater detail in his reports” than the opposing experts, he “more coherently

and effectively communicated the basis for [his] opinions.” Bushnell v. Sec’y of

Health & Human Servs., No. 02-1648V, 2015 WL 4099824, at *15 (Fed. Cl. Spec.

Mstr. June 12, 2015). He also is not reticent to critique or strongly disagree with

opposing experts’ theories or contentions. See Rogero v. Sec’y of Health &

Human Servs., No. 11-770V, 2017 WL 4277580, at *53 (Fed. Cl. Spec. Mstr. Sept.

1, 2017), mot. for rev. denied, slip op. (Fed. Cl. Jan. 11, 2018), aff’d, 748 F. App’x

996 (2018), petition for cert. denied, 140 S. Ct. 378, 205 (2019), petition for reh'g

denied, 140 S. Ct. 656 (2019); see also Hooker v. Sec’y of Health & Human

Servs., No. 02-472V, 2016 WL 3456435, at *36 (Fed. Cl. Spec. Mstr. May 19,

2016) (“Respondent’s expert medical toxicologist, Dr. Cetaruk, was highly

persuasive in his detailed critique of Dr. Haley’s theory.”).

4. Dean Jones

Professor Jones received his Ph.D. from the Oregon Health Sciences

University in 1976. While he is not a medical doctor, the Emory University

School of Medicine appointed him to be a professor in the department of medicine

in 2003. Exhibit L (Professor Jones’s curriculum vitae).

Professor Jones is an expert in the field of oxidative stress. Tr. 633. In this

case, his task was to evaluate Dr. Niyazov’s theory that vaccines caused Trystan

oxidative stress and this oxidative stress harmed Trystan. Professor Jones did not

find support for this theory. Tr. 646, 659. However, like Dr. Cetaruk’s opinions

regarding alum, Professor Jones’s opinions about oxidative stress are outside the

scope of the remand order.

Other special masters have commented on Professor Jones’s cohesive

testimony. He has “testified knowledgeably and understandably.” Mead v. Sec’y

of Health & Human Servs., No. 03-215V, 2010 WL 892248, at *9 (Fed. Cl. Spec.

Mstr. Mar. 12, 2010). He is also thought to be “logical” in the presentation of his

theories and opinions. Dwyer v. Sec’y of Health & Human Servs., No. 03-1202V,

2010 WL 892250, at *115 (Fed. Cl. Spec. Mstr. Mar. 12, 2010). This is

particularly with respect to his expertise in the concept of oxidative stress—an area

in which his testimony has been considered very persuasive in past cases. See Bast

v. Sec’y of Health & Human Servs., No. 01-565V, 2012 WL 6858040, at *5 (Fed.

Cl. Spec. Mstr. Dec. 20, 2012), mot. for rev. denied sub. nom., M.S.B. v. Sec’y of

Health & Human Servs., 117 Fed. Cl. 104 (2014), app. dismissed, 579 F. App’x

1001 (Fed. Cir. 2014); Dwyer, 2010 WL 892250, at *115.

29

The backgrounds of the experts, particularly Doctors Steinman, Niyazov,

and Raymond, contribute to the resolution of this case.

IV. Standards for Adjudication

Petitioners are required to establish their case by a preponderance of the

evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence

standard requires a “trier of fact to believe that the existence of a fact is more

probable than its nonexistence before [he] may find in favor of the party who has

the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of

Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations

omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &

Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).

Distinguishing between “preponderant evidence” and “medical certainty” is

important because a special master should not impose an evidentiary burden that is

too high. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1379-80

(Fed. Cir. 2009) (reversing special master's decision that petitioners were not

entitled to compensation); see also Lampe v. Sec’y of Health & Human Servs., 219

F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Human Servs., 9 F.3d

958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge’s contention that the

special master confused preponderance of the evidence with medical certainty).

Petitioners bear a burden “to show by preponderant evidence that the

vaccination brought about [the vaccinee’s] injury by providing: (1) a medical

theory causally connecting the vaccination and the injury; (2) a logical sequence of

cause and effect showing that the vaccination was the reason for the injury; and (3)

a showing of a proximate temporal relationship between vaccination and injury.”

Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).

The Althen prongs are reviewed in the sections that follow. Because the

medical theory is foundational to the claim that the DTaP vaccine harmed Trystan,

the medical theory (prong 1) is reviewed first in section V. The medical theory, in

turn, is the basis for determining the time for which an adverse reaction to the

DTaP vaccine is expected to occur. Thus, section VI addresses the appropriate

temporal relationship. As briefly explained at the end of section VI, the Sanchezes

have not persuasively demonstrated that Trystan’s neurologic problem developed

within the expected time. Thus, the Sanchezes do not meet their burden of proof

regarding prong 3. Section VII expands upon when Trystan began to manifest

neurologic problems by reviewing in detail the medical records to show that the

30

Sanchezes have not established a logical sequence of cause and effect between the

vaccination and Trystan’s Leigh’s syndrome.

V. Althen Prong 1

On remand, the parties dispute whether the remand allows for a re-

adjudication of the evidence as to whether the DTaP vaccine can cause

neurodegeneration as part of Leigh’s syndrome. Because of the procedural

posture, the remand does not permit another examination of this evidence.

A. Procedural History regarding Prong 1

The October 9, 2018 decision found the Sanchezes met their burden

regarding prong 1. The decision states:

To demonstrate that vaccinations can cause the onset of Leigh’s

syndrome, the Sanchezes provide evidence showing that the

onset of Leigh’s syndrome is associated with a decompensating

event10 and that vaccination could cause such a decompensating

event. Though a link between vaccination and the onset of

Leigh’s syndrome has not been established to the standard of

medical certainty, for the reasons elucidated below, the

evidence presented is sufficient to conclude that the Sanchezes’

theory is plausible insofar as it is consistent with contemporary

understanding of the biological systems at play. Accordingly,

the Sanchezes have met their statutory burden on this element

as the Federal Circuit has defined it. See Hibbard v. Sec’y of

Health and Human Servs., 698 F.3d 1355, 1365 (Fed. Cir.

2012) (noting that petitioners’ burden is to provide a “viable

medical theory by which a vaccine can cause the injury claimed

by the petitioner”).

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

10

Decompensation is a period of regression that is frequently seen in cases of Leigh’s

disease. Exhibit 148 (Rahman) at 1. Dr. Raymond testified that decompensation in individuals

with Leigh’s syndrome is clinically obvious and is characterized by encephalopathy, decreased

consciousness, weakness, and motor difficulties. Tr. 794-95. Dr. Niyazov largely agreed with

this characterization of decompensation but noted that the decompensation can be followed by

periods of prolonged stabilization and possibly even improvement. See Tr. 417.

31

For a special master to find that a petitioner has met his burden with respect

to prong 1, a petitioner must provide a persuasive – not merely a “plausible” –

medical theory connecting the vaccine to the alleged injury. See Boatmon v. Sec’y

of Health & Human Servs., 941 F.3d 1351, 1357 (Fed. Cir. 2019). The Federal

Circuit has established and reaffirmed the insufficiency of the “plausibility”

standard in multiple cases. See LaLonde v. Sec’y of Health & Human Servs., 746

F.3d 1334, 1339 (Fed. Cir. 2014) (“[S]imply identifying a ‘plausible’ theory of

causation is insufficient for a petitioner to meet her burden of proof.”); Moberly v.

Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010) (rejecting

“proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and injury” as

the applicable statutory standard); see also Boatmon, 941 F.3d at 1360 (“We have

consistently rejected theories that the vaccine only ‘likely caused’ the injury and

reiterated that a ‘plausible’ or ‘possible’ causal theory does not satisfy the

standard.”).

Before the Court of Federal Claims and the Federal Circuit, the Secretary

argued that the undersigned evaluated the evidence according to the wrong

evidentiary standard. Resp’t’s Resp. to Mot. for Rev. at 9 n.10; Br. of Appellee-

Respondent at 16 n.5. In both briefs, the Secretary presented this argument in

footnotes and contended that given the findings on the other Althen prongs, any

error was “harmless.”

The Federal Circuit appeared to endorse the theory that vaccines can cause

fever and fever can cause neurodegeneration based upon its opinion in Paluck.11

Specifically, the Federal Circuit stated that “as in this case, the evidence in Paluck

showed that vaccines can activate the immune system, which in an individual with

a mitochondrial disease can result in oxidative stress that can, in turn, cause

progressive neurological deterioration over time.” Sanchez, 809 F. App’x at 851

(citing Paluck, 786 F.3d at 1380-81).

11

The degree to which Paluck, itself, made findings regarding this theory has been

questioned. See Reed v. Sec’y of Health & Human Servs., No. 08-650V, 2018 WL 6844458, at

*90 n.150 (Fed. Cl. Spec. Mstr. Dec. 4, 2018); Pope v. Sec’y of Health & Human Servs., No. 14-

078V, 2017 WL 2460503, at *11 (Fed. Cl. Spec. Mstr. May 1, 2017) (noting that the Secretary

did not challenge prong 1 after the first remand); H.L. v. Sec’y of Health & Human Servs., No.

10-0197V, 2016 WL 3751848, at *14-15 (Fed. Cl. Spec. Mstr. Mar. 17, 2016), mot. for rev.

denied, 129 Fed. Cl. 165 (2016), aff’d, 715 F. App’x 990 (Fed. Cir. 2017).

32

B. Arguments on Remand regarding Prong 1

The undersigned directed the parties to address whether evaluation of prong

1 was required. Order, issued July 10, 2020. In response, the Secretary maintained

that nothing precludes a further analysis. Resp’t’s Remand Br. at 19. The

Secretary did not discuss either the law of the case doctrine or the mandate rule in

this context.

The Sanchezes’ initial brief was similarly undeveloped. Also without citing

any authority, the Sanchezes maintained that reevaluation of prong 1 is precluded.

Pet’rs’ Remand Br. at 85. But, the Sanchezes expanded those arguments in reply. 12

They contended that noting an objection does not elevate an appellate issue and the

Secretary did not file his own appeal regarding prong 1. Thus, in the Sanchezes’

view, the lack of appellate pursuit of this issue by the Secretary amounts to a

waiver of any argument. Pet’rs’ Reply on Remand at 23-24.

C. Resolution

Preliminarily, the Sanchezes’ suggestion that the Secretary was required to

file an appeal appears misplaced. See Aventis Pharma S.A. v. Hospira, Inc., 637

F.3d 1341 (Fed. Cir. 2011) (granting motion to strike a cross-appeal that did not

seek to expand the putative cross-appellant’s rights under the judgment).

However, the Sanchezes’ comments regarding how the Secretary presented his

“harmless error” argument---in a footnote to the Federal Circuit---may be more

meaningful. See SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312,

1320 (Fed. Cir. 2006) (explaining an argument needs to be developed, not just in a

footnote). Regardless, the undersigned trusts that the Federal Circuit considered

the Secretary’s arguments regarding prong 1. See Allapattah Services, Inc. v.

Exxon Corp., 372 F. Supp. 2d 1344, 1364 (S.D. Fla. 2005) (“This Court will not

presume that the Circuit panel completely disregarded an argument specifically

raised on appeal”). Furthermore, the doctrine of the law of the case, which

precludes relitigation of issues explicitly or implicitly decided on appeal, sheds

light on implicit appellate considerations of arguments. See Travelers Ins. Co. v.

United States, 72 Fed. Cl. 316, 325 (2006) (“The doctrine [of the law of the case],

of course does not constrain a trial court’s consideration of an issue that has not

been considered on appeal. [] But the doctrine extends to issues that were

implicitly addressed.” (citing W.L. Gore & Assocs., Inc. v. Garlock, Inc., 842 F.2d

12

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

33

1275, 1278 (Fed. Cir. 1988) (“The doctrine [of the law of the case] applies not only

to issues discussed and decided but also those decided by necessary

implication.”))); American Satellite Co. v. United States, 34 Fed. Cl. 468, 480

(1995) (“Although the opinion issued by the Federal Circuit did not address the

waiver question . . . further consideration of this issue is precluded by the appellate

decision. . . . [T]he law of the case doctrine applies to issues implicitly decided by

the appellate court.”).

“Upon return of its mandate, the district court cannot give relief beyond the

scope of that mandate, but it may act on matters left open by the mandate.”

Laitram Corp. v. NEC Corp., 115 F.3d 947, 951 (Fed. Cir. 1997) (quoting Caldwell

v. Puget Sound Elec. Apprenticeship & Training Tr., 824 F.2d 765, 767 (9th Cir.

1987)) (internal quotation marks omitted). Here, the Federal Circuit’s mandate

does not indicate that the undersigned should reconsider the findings regarding

prong 1 in the October 9, 2018 decision. Indeed, if anything, the Federal Circuit

seems to be agreeing with the outcome reached in the October 9, 2018 decision on

prong 1.

Accordingly, the finding in the October 9, 2018 decision remains

undisturbed. The theory that the DTaP vaccine can cause neurodegeneration,

potentially through the intermediate step of a fever, is sound and reliable under

prong 1.

VI. Althen Prong 3

“[T]he proximate temporal relationship prong requires preponderant proof

that the onset of symptoms occurred within a timeframe for which, given the

medical understanding of the disorder’s etiology, it is medically acceptable to infer

causation-in-fact.” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347,

1352 (Fed. Cir. 2008). Thus, the third prong of Althen implicitly has two parts. A

petitioner must show the “timeframe for which it is medically acceptable to infer

causation” and that the onset of the disease occurred in this period. Shapiro v.

Secʼy of Health & Human Servs., 101 Fed. Cl. 532, 542-43 (2011), recons. denied

after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d without op., 503 F.

App’x 952 (Fed. Cir. 2013).

As explained in section A, below, the parties have disputed both parts of

prong 3. Thus, the procedural history of the parties’ arguments on prong 3 are set

forth in detail. The procedural history shows that the appropriate temporal

relationship that was found in the October 9, 2018 decision was not disturbed on

appeal. For reasons described in section B, below, this remand decision again

34

finds the same appropriate temporal relationship between a vaccination and the

onset of neurologic deterioration.

A. Procedural History regarding Prong 3

The October 9, 2018 decision discussed evidence regarding the appropriate

timing between a decompensating event and the onset of neurologic symptoms,

including Edmonds (exhibit 75), Shoffner (exhibit 86), and the Poling case report

(exhibit 54). See Joseph L. Edmonds et al., The Otolaryngological Manifestations

of Mitochondrial Disease and the Risk of Neurodegeneration With Infection, 128

Arch Otolaryngol Head Neck Surg. 355 (2002), filed as exhibit 75; John Shoffner

et al., Fever Plus Mitochondrial Disease Could Be Risk Factors for Autistic

Regression, 254 J. Child Neurology 429 (2010), filed as exhibit 86; Jon S. Poling

et al., Developmental Regression and Mitochondrial Dysfunction in a Child With

Autism, 21 J. Child Neurology 170 (2006), filed as exhibit H-15. While these

articles “are far from comprehensive,” they suggested that neurodegeneration

would occur within approximately two weeks. Decision at 26, 2018 WL 5856556,

at *16. However, the October 9, 2018 decision attempted to avoid setting a “hard

and fast deadline,” which would conflict with the dictate in Paluck, 786 F.3d at

1383. Accordingly, the October 9, 2018 decision did not specify the outside time

frame at which neurodegeneration could appropriately be linked to an antecedent

event. But, the October 9, 2018 decision found that the Sanchezes failed to

establish that they were entitled to compensation because of (a) the length of time

between the February 5, 2009 vaccination and the onset of Trystan’s

neurodegeneration, which started no earlier than May 1, 2009 (almost three months

later), and (b) infections that Trystan suffered much closer in time to the onset of

his neurodegeneration.

In their motion for review, the Sanchezes challenged the evaluation of the

appropriate temporal relationship. 13 The Sanchezes argued that the October 9,

2018 decision violated Paluck, interpreted the Edmonds article incorrectly, and

ignored (or overlooked) the testimony of Dr. Niyazov that a fade response could

extend the appropriate temporal relationship out to two or three months. Pet’rs’

Mot. for Rev. at 20-25. In reply, the Sanchezes added an argument that the

13

This aspect of the Sanchezes’ argument corresponds to the first part of Althen prong 3.

The Sanchezes also presented arguments about the second part of Althen prong 3, when Trystan

began to suffer neurodegeneration. Those are addressed in sections VI.B & VI.C below.

35

October 9, 2018 decision conflicted with Paluck in that the undersigned relied

upon small studies.

In denying the Sanchezes’ motion for review, the Court of Federal Claims

rejected the Sanchezes’ arguments. In particular, the Court of Federal Claims

ruled that the undersigned did not violate Paluck because the decision did not set a

hard and fast deadline. The Court further ruled that the special master did not have

to accept the Sanchezes’ argument that the appropriate temporal relationship could

extend to two or three months. Opinion and Order at 255-56.

On appeal to the Federal Circuit, the parties’ arguments with respect to the

appropriate temporal relationship largely, if not entirely, matched their arguments

to the Court of Federal Claims. For example, the Sanchezes again argued that the

special master ignored Dr. Niyazov’s testimony about the Naviaux article. The

Sanchezes also argued that the October 9, 2018 decision erroneously set a hard and

fast deadline, in violation of Paluck.

In disagreement with the Sanchezes’ arguments, the Federal Circuit ruled

that the decision was in accord with Paluck. The Federal Circuit did not comment

upon the usefulness of the Naviaux article. However, the Federal Circuit

remanded for a separate analysis of prong 2 and prong 3. The Federal Circuit

required that the undersigned find whether Trystan’s February 16, 2009 arm

contortions could contribute to finding that the Sanchezes met their burden with

respect to Althen prong 3.

On remand, the parties were instructed to present arguments regarding both

parts of Althen prong 3. Order, issued July 10, 2020. For the temporal interval for

which an inference of causation is appropriate (part 1), the parties appeared to

struggle to set any bounds. Copying from their July 7, 2017 pre-hearing brief, the

Sanchezes argued that neurodegeneration would often occur within two weeks,

possibly three weeks after the inciting event. Pet’rs’ Remand Br. at 53-64. The

Secretary did not specify an appropriate amount of time, other than to maintain that

“several months” is too long. Resp’t’s Remand Br. at 20. In reply, the Sanchezes

presented very little, if anything, about the appropriate temporal relationship. See

Pet’rs’ Remand Reply at 10-14 (discussing prong 2).

B. Analysis of Althen Prong 3, part One

At its foundation, Althen requires “a showing of a proximate temporal

relationship between vaccination and injury.” 418 F.3d at 1278. Subsequent

Federal Circuit cases have developed aspects of this element. For example,

36

Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1358 (Fed. Cir. 2006),

explained “[i]f, for example, symptoms normally first occur ten days after

inoculation but petitioner’s symptoms first occur several weeks after inoculation,

then it is doubtful the vaccination is to blame.” Id. de Bazan linked the medically

acceptable timeframe to the “medical understanding of [a] disorder’s etiology.” de

Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).

In accord with these precedents, special masters may reject an opinion that is so

indefinite about the appropriate temporal relationship that the opinion would

effectively render the third Althen prong a nullity. Hennessey v. Sec’y of Health

& Human Servs., 91 Fed. Cl. 126, 141-42 (2010). Similarly, special masters may

find that when the onset of a disease occurs outside the expected temporal interval,

petitioners are not entitled to compensation. Greene v. Sec’y of Health & Human

Servs., No. 11-631V, 2019 WL 4072110, at *21 (Fed. Cl. Spec. Mstr. Aug. 2,

2019), mot. for rev. denied, 146 Fed. Cl. 655 (2020).

While those cases suggest that sometimes the interval between the

vaccination and the onset of symptoms is too long to support a finding of

causation-in-fact, Paluck cautions against defining the limits too rigidly. With this

guidance, the undersigned attempted to point out that the evidence, imperfect as it

might be, seemed to coalesce around a finding that two weeks from vaccination to

the onset of neurologic decline is an interval that would support a finding of

causation.14 Decision at 25, 2018 WL 5856556, at *15. Yet, at the same time, the

undersigned tried to balance what the evidence showed with Paluck’s recognition

14

The Sanchezes’ criticism that the undersigned erred in relying upon small studies, see

Pet’rs’ Reply in Support of Mot. for Rev. at 11-12; see also Pet’rs’ Mot. for Rev. at 31

(highlighting the portion of Paluck that identifies the Shoffner and Edmonds articles, and Poling

case study, as not establishing a definitive time frame due in part to small patient sample sizes);

Pet’rs’ Remand Br. at 63 (same), seems misplaced in that the Sanchezes introduced the studies,

such as Edmonds and Shoffner, on which the undersigned relied. Special masters have

commented that they base decisions on studies with small samples because “[e]vidence from

small studies may be the only evidence available to support or undercut an opinion on

causation.” Holt v. Sec’y of Health & Human Servs., No. 05-0136V, 2015 WL 4381588, at *30

n.84 (Fed. Cl. Spec. Mstr. June 24, 2015); see also H.L. v. Sec’y of Health & Human Servs., No.

10-0197V, 2016 WL 3751848, at *11 (Fed. Cl. Spec. Mstr. Mar. 17, 2016) (“[T]he Edmonds

study remains the only evidence in this record regarding the expected timing of a neurologic

deterioration[.]”), mot. for rev. denied, 129 Fed. Cl. 165, 175-76 (2016) (rejecting argument that

special master erroneously relied upon Edmonds), aff’d, 715 F. App’x 990, 997 (Fed. Cir. 2017)

(“The special master’s ‘requirement for strong temporal evidence’ in this regard does not

contravene Paluck and is ‘consistent with the third prong of the Althen test.’”).

37

that more studies would be helpful. Cf. Sharpe v. Sec’y of Health & Human

Servs., 964 F.3d 1072, 1083 (Fed. Cir. 2020) (criticizing special master for noting

that different evidence could lead to a different result).

On appeal, the Federal Circuit did not correct this approach. Because the

mandate does not remand for reconsideration of the first part of Althen prong 3, the

undersigned will again primarily look for evidence of neurologic decline within

two weeks of the vaccination. However, if Trystan’s neurologic decline were to

occur slightly outside of two weeks, then the Sanchezes could meet their burden

regarding Althen prong 3.15

C. Analysis of Althen Prong 3, part Two

The ensuing question, a topic of the Federal Circuit’s remand, is whether the

Sanchezes presented persuasive evidence that Trystan began to suffer lasting

neurologic problems within approximately two weeks of the vaccination. 16 The

short answer is that the Sanchezes have not. When the record is considered as a

whole, the symptoms that Trystan displayed on February 5, 2009, as well as on

February 15-16, 2009, including his arm contortions, are not manifestations of a

neurologic disorder. The longer answer and more detailed explanation are

provided as part of the prong 2 analysis below.

VII. Althen Prong 2

On remand, the procedural history of the arguments regarding prong 2,

which is set out in section A, again complicate the issues. A chief question is

when Trystan started to experience neurodegeneration because if, as the

Sanchezes’ theory predicts, Trystan developed neurodegeneration within a short

time (approximately two weeks) after the vaccination, then a “logical” conclusion

might be that the vaccination caused the neurodegeneration. This argument is

15

Even if the Federal Circuit remanded the question of Althen prong 3, part 1, the

undersigned would still find that the evidence weighs in favor of finding that neurodegeneration

would occur within approximately two weeks from an allegedly inciting event. Even Naviaux

indicates that the fade response is “typically delayed two to ten days after a fever.” Tr. 438 (Dr.

Steinman).

16

The qualification of “lasting” problems refers to the requirement that petitioners must

establish that an injury persisted longer than six months. 42 U.S.C. § 300aa-11(c)(1)(D). As

such, while the vaccination caused Trystan to have a fever and to cry inconsolably, this initial

and transient reaction is not compensable.

38

developed in section B, which restates the theory the Sanchezes and their experts

advance. Section B also includes a detailed analysis of Trystan’s health at various

times, corresponding to visits to medical providers. Section B ultimately presents

the finding that Trystan’s neurodegeneration began later than the time predicted by

the Sanchezes’ theory. Within this section on the logical sequence of cause and

effect (section V), there is an analysis of reports from doctors who treated Trystan

because the reports of treaters may influence the outcome on prong 2.

A. Procedural History regarding Logical Sequence of Cause and

Effect / Onset of Neurodegeneration

As discussed above with respect to prong 3, the October 9, 2018 decision

found that the Sanchezes failed to establish that the DTaP vaccination caused

Trystan’s neurologic problems because Trystan lost skills no earlier than May or

June 2009, which was too long after the February 5, 2009 vaccination to infer

causation-in-fact and because Trystan suffered infections in April and May.

Decision at 22-24, 2018 WL 5856556, at *13-15.

In their motion for review, the Sanchezes argued that the undersigned was

arbitrary in that the October 9, 2018 decision failed to address their position that

the neurodegeneration began immediately after the February 5, 2009 vaccination

when Trystan had a fever, inconsolable crying, and a hot spot on his leg. Pet’rs’

Mot. for Rev. at 32. Specifically, the Sanchezes argued that the undersigned did

not adequately address Dr. Steinman’s and Dr. Niyazov’s contentions that “fever,

irritability, and other signs” were indicators of the onset of neurodegeneration as

part of a development process that does not adhere to a “rigid timeframe for when

the clinical symptoms of vaccine-induced neurodegeneration would be expected to

appear.” Id. Similarly, in their motion, the Sanchezes added that the undersigned

improperly ignored evidence that Trystan faded after the vaccination. See id. at

10.

The Court did not accept the Sanchezes’ arguments. The Court ruled that

the Sanchezes were suggesting that the undersigned wrongly weighed evidence

regarding the onset of neurodegeneration. The Court, accordingly, determined that

such an argument about re-weighing evidence was not acceptable and denied the

motion for review on this point. Opinion and Order at 254.

At the Federal Circuit, the Sanchezes returned to the issue of when Trystan’s

neurodegeneration began. The opening section of their initial brief as well as the

opening section of their reply brief is devoted to the topic of the onset of

neurodegeneration. Br. of Appellants-Petitioners at 4; Reply of Appellants-

39

Petitioners at 1. They argued that Trystan’s crying and fever marked the beginning

of his neurodegeneration. Br. of Appellants-Petitioners at 34; Reply of Appellants-

Petitioners at 7. They also compared Trystan to the children in Markovich and

Paluck.

The Federal Circuit did not directly address whether Trystan’s fever and

crying from the day and evening after the February 5, 2009 vaccination constituted

a manifestation of neurodegeneration. However, the Federal Circuit remanded for

consideration of whether Trystan’s February 16, 2009 arm contortions were a

manifestation of a neurological injury. Sanchez, 809 F. App’x at 853.

On remand, the Sanchezes’ position with respect to onset is not thoroughly

consistent. The Sanchezes primarily advance the position that Trystan’s fever and

inconsolable crying on February 5, 2009, were the first manifestation of his

neurologic injury. Pet’rs’ Remand Br. at 42. They fault the October 9, 2018

decision for not addressing their claim that Trystan’s fever, irritability, and

potential encephalopathy are the onset of his neurologic disorder. Id. at 49. They

go so far as to argue that the undersigned’s Remand Decision must address the

fever, inconsolable crying, and arm contortions. Id. at 51. However, by quoting

Dr. Steinman’s June 15, 2020 report, the Sanchezes also state that the February 16,

2019 arm contortions are “evidence of the onset of neurodegeneration.” Id. at 13-

14 (quoting exhibit 185).

The Secretary’s argument with respect to Trystan’s onset of neurologic

problems focuses on Trystan’s behavior on February 16, 2009. The Secretary

appears not to address Trystan’s behavior on February 5, 2009. Resp’t’s Remand

Br. at 19-21; see also Br. of Appellee-Respondent at 17, 24 (attributing all

Trystan’s problems in February 2009 to a cold).

In the sections that follow, the undersigned will address Trystan’s neurologic

status at different periods, including February 5, 2009; February 16-17, 2009; the

end of February through early April 2009; April-May 2009; August 2009; and

October-December 2009. As part of the final section (October-December 2009),

the undersigned will discuss challenge-rechallenge. The undersigned will also

address the contributions of treating doctors in this case and evaluate their

relevance and weight in analyzing the Sanchezes’ claim. But, the analysis of

Althen prong 2 begins with a recapitulation of the Sanchezes’ theory of how the

DTaP vaccine can harm Trystan.

40

B. Summary of Causal Theory

The second element in Althen’s formulation of elements to establish

causation-in-fact is “a logical sequence of cause and effect showing that the

vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. A “logical”

sequence suggests that the vaccinee responded in a way consistent with the causal

theory. For example, when a petitioner presents a theory that a vaccine can attack

the autonomic nerves, the special master may find against the petitioner due to the

lack of preponderant evidence showing an autonomic neuropathy. Hibbard v.

Sec’y of Health & Human Servs., 698 F.3d 1355, 1364 (Fed. Cir. 2012); see also

Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. 43, 54 (2013)

(“Petitioner’s argument fails because . . . the Chief Special Master tested the

proposed mechanism of causation . . . and found that the proposed mechanism, as

applied to the facts of S.S.’s seizures . . . failed to provide a logical sequence of

cause and effect.”); La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl.

184, 205 (2013) (affirming a special master’s determination that the non-existence

of an asserted condition constituted a “missing link” in the Althen prong 2

causation analysis), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). Thus, a petitioner’s

causal theory affects whether the evidence offered in an attempt to show “that the

vaccination was the reason for the injury” is “logical.”

Here, through opinions of their experts and arguments of their attorney, the

Sanchezes maintain that Trystan’s response to the vaccine changed his life. After

the vaccination, Trystan started “a downward cascade.” Tr. 278 (Dr. Steinman).

Dr. Steinman confirmed his opinion in his testimony on remand. Tr. 2033-34. He

saw Trystan’s deterioration as “one continuous process”, Tr. 294, and “evolving in

a continuum,” Tr. 296-97. “[T]he dynamic effect of the shot was to create damage

in the nervous system which, as the child developed, became apparent at different

points with losing skills and other manifestations.” Tr. 295. Dr. Steinman further

stated that, while there are various reasons a child’s loss of skills may be subtle, at

a certain point in Trystan’s medical history, doctors began noting concrete and

serious loss of milestones, which “didn’t happen overnight.” Tr. 296. On remand,

Dr. Steinman characterized Trystan as taking a “big hit” in February. Tr. 2042.

Dr. Niyazov wrote that Trystan’s “developmental regression was slowly

developing ever since the crying and fever took place as a result of the

vaccination.” Exhibit 68 at 8. Dr. Niyazov testified that the vaccination and its

associated inflammation took energy from Trystan from which he could not

recover for two to three months. Tr. 415-16. Dr. Niyazov testified that Trystan’s

41

Leigh’s syndrome started with the fever and inconsolable crying on February 5,

2009. Tr. 457.17

In addition to presenting this testimony from their experts, the Sanchezes

analogize their case to two cases, Markovich and Paluck, which reached the

Federal Circuit. They also compare their case to Poling. Thus, a review of the

facts in those cases is appropriate.

Markovich

Ashlyn Markovich received a set of vaccinations, including the DTaP

vaccine, on July 10, 2000. Markovich v. Sec’y of Health & Human Servs., No. 03-

2015V, 2005 WL 6117470, at *1 (Fed. Cl. Spec. Mstr. July 22, 2005). Later that

day, Ashlyn started to blink her eyes “repeated[ly].” Id. Supported by an affidavit,

the petition alleged that “after Ashlyn’s July 10, 2000 vaccinations and continuing

to August 30, 2000, the parents observed Ashlyn rapidly blinking her eyes.” Id. A

pediatric neurologist who testified for the petitioners, Jean-Ronel Corbier, accepted

the assertions contained in the affidavit. Dr. Corbier opined that “[T]here is a

possibility that these rapid frequent eye blinking episodes may have represented

seizures.” Id. at *1 n.9. Another doctor, Donald H. Marks, opined that the DTaP

vaccination caused the development of the seizure disorder. Id. at *1 n.8.

“Ashlyn’s first full-blown seizure . . . occur[ed] [on] August 30 or 31, 2000.” Id.

at *1.

To determine whether the petition, which was filed on August 29, 2003, was

filed within the three-year statute of limitations, the special master held a hearing

during which the only person to testify was Dr. Corbier. Id. at *2. “Dr. Corbier

explained that although rapid eye blinking alone is insufficient to establish a

seizure disorder diagnosis, as a neurologist, the eye blinking episode would have

raised his suspicions and he would have pursued further investigation[.]” Id. at

*11. Dr. Corbier also made “plain that the eye blinking episodes were part of a

progression of symptoms.” Id. In opining that the July 10, 2000 DTaP vaccination

17

Later, on remand, Dr. Niyazov stated that this testimony was not accurate. Dr.

Niyazov stated that Trystan’s Leigh’s syndrome began on December 15, 2009, when he

underwent an MRI, because an MRI is only mechanism by which Leigh’s syndrome could be

diagnosed. Tr. 2072-73. He stated that he may have misspoke at the original entitlement hearing

by making “a common error where when people sometimes have interchangeable use of the

words mitochondrial complex II deficiency and Leigh’s disease.” Id. 2072. This remand

testimony from Dr. Niyazov was confusing and not persuasive.

42

caused the August 30, 2000 seizure, “Dr. Corbier explained that if there had been

no evidence of brain dysfunction between July 10, 2000, and August 30, 2000, it

would be more difficult to prove that the vaccinations Ashlyn received on July 10,

2000, were the cause of her seizure disorder.” Id. at *13.

Dr. Corbier’s opinion about the significance of the eye blinking episodes

was “critical to the special master’s decision.” Id. The special master found that

because Ashlyn manifested some neurologic problem on July 10, 2000, the statute

of limitations began to run on that day. The special master rejected the petitioners’

arguments that because they did not recognize until later the significance of the eye

blinking episodes, the statute of limitations should not start running until August

30, 2000. Id. at *14. Therefore, despite sympathy for the Markoviches, the special

master found that the statute of limitations barred the petition. 18

In the present case, the Sanchezes compare Trystan to Ashlyn. To the

Sanchezes, Trystan’s “fever, hot spot, and inconsolable crying” are the onset of his

neurological disorder just as Ashlyn’s eye blinking marked a manifestation of her

seizure disorder. To continue the analogy, the Sanchezes state Trystan’s “loss of

skills in May 2009 is similar to the grand mal seizure.” Pet’rs’ Remand Br. at 43.

However, Trystan and Ashlyn differ. The differences are apparent in at least

two ways. First, in Markovich, Dr. Corbier accepted the parental account that

Ashlyn had repeated and frequent episodes of eye blinking between the day of

vaccination and the August 30, 2000 seizure. The numerous instances allowed Dr.

Corbier to see a “progression of symptoms.”19 In contrast, Trystan did not display

any neurologic problems for weeks after the February 16, 2009 incident.

Second, in Markovich, Dr. Corbier’s opinion that the eye blinking

constituted a manifestation of a neurologic disorder was unopposed. Here, while

Dr. Steinman and Dr. Niyazov maintain that Trystan’s neurodegeneration began on

18

The Court of Federal Claims ruled that the special master’s reliance on Dr. Corbier’s

testimony was not arbitrary and denied the petitioners’ motion for review. 69 Fed. Cl. 327

(2005). The Federal Circuit affirmed. 477 F.3d 1353 (Fed. Cir. 2007).

19

In evaluating the motion to dismiss for failure to file within the time the statute of

limitations permits, the special master seemed to accept the reliability of the affidavit. The

Secretary, however, noted that “there is no mention in the medical records of Ashlyn’s eye

fluttering.” Markovich, 2005 WL 6117470, at *2.

43

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

further below.

Paluck

The Sanchezes often compare their case to Paluck. See, e.g., Pet’rs’ Pre-

hear’g Br., filed July 7, 2017, at 17-19, 46-50; Pet’rs’ Mot. for Rev., filed Nov. 8,

2018, at 20-32; Br. of Appellants-Petitioners at 18-19, 23, 28, 35-48; Pet’rs’

Remand Br. at 61-64. Therefore, a brief (not exhaustive) review of the facts of

Paluck is appropriate.

The vaccinee in Paluck was a child named Karl Paluck. He most likely was

born with a mitochondrial disorder. Paluck v. Sec’y of Health & Human Servs.,

113 Fed. Cl. 210, 213 (2013), aff’d, 786 F.3d 1373 (Fed. Cir. 2015). Before

vaccinations around his first birthday in January 2005, Karl was diagnosed with

developmental delays in various domains. Id. at 214. Within two days of the

vaccinations, his daycare provider documented that Karl was running a fever, was

irritable, and had fatigue. Id. at 216. Within the next two weeks, Karl “was often

fussy, did not eat or nap well, and was tired.” Id. at 217.

About three weeks after vaccination, Karl’s parents brought him to a

chiropractor because Karl was having problems sitting, crawling, and walking. Id.

Over the next two months, the chiropractor recorded a series of variable subjective

assessments about Karl’s abilities. Id.

By April 2005, Karl’s pediatrician and a pediatric neurologist to whom Karl

had been referred were identifying worse problems with Karl. In short, Karl was

experiencing “global delayed development.” Id. at 218. He further deteriorated

from April to July. Id. at 219. In July, Karl had a seizure and an MRI suggested

that Karl was suffering from neurodegeneration. Id.

The Court found that the Palucks’ case should be analyzed as a significant

aggravation case, not a new injury case. Id. at 228. The Court then applied the six

elements from Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144

(2009).

With respect to the sixth Loving factor, which corresponds to Althen prong

3, the Court declined to set “a hard and fast time frame” for which a vaccination

would aggravate a mitochondrial disorder. Paluck, 113 Fed. Cl. at 240.

Nevertheless, the Court recognized that, at a minimum, the experts agreed that a

change would begin “within a few weeks.” Id. (quoting testimony from the

44

Secretary’s expert). The experts’ opinions derived, in part, from the Edmonds

article, the Shoffner study, and the Naviaux commentary on the Shoffner study.

The Court found that the Palucks had established their burden of showing

that Karl experienced neurodegeneration within this period. The Court credited the

testimony of the Palucks’ expert who relied upon a relatively early notation by the

chiropractor that Karl was “spastic” on February 11, 2005. According to the

Court, “[s]tarting with this chiropractic notation, the record shows that Karl

experienced a general decline.” Id. Karl exhibited various issues continually

before and after vaccination, including developmental delays, bouts of otitis media

and erythema multiforme, neuromuscular issues, global developmental delay, and

skin lesions. Id. at 213-18.

Poling

Through Dr. Niyazov, the Sanchezes have compared Trystan to Hannah

Poling. See Pet’rs’ Pre-hear’g Br., filed July 7, 2017, at 47-50; Pet’rs’ Mot. for

Rev., filed Nov. 8, 2018, at 26, 31; Pet’rs’ Reply in Support of their Mot. for Rev.

at 11-12.20 While the Poling case carries some renown in the Vaccine Program, the

events in Hannah Poling’s life should be reviewed again.

At age 19 months, Hannah Poling received multiple vaccinations, including

the diphtheria-tetanus-pertussis and varicella vaccines. Within 48 hours, she

developed a fever, inconsolable crying, irritability, and lethargy, and refused to

walk. Four days later, she could not walk up stairs normally. Over the next three

months, she was “irritable and increasingly less responsive verbally, after which

the patient’s family noted clear autistic behaviors.” Exhibit H-15 (Poling) at 170.21

Hannah’s parents sought compensation through the Vaccine Program.22 The

Secretary conceded that the Polings were entitled to compensation because

20

In these contexts, the Sanchezes also rely upon the Court’s citation to Poling in Paluck.

21

The Poling case report as published in the Journal of Child Neurology appears as

exhibit H-18. A manuscript version was filed as exhibit 84.

22

Hannah’s father, Dr. Jon Poling, later stated that he “should have declared [his]

daughter’s identity in a separate letter to [Journal of Child Neurology].” Poling 2008, filed as

exhibit 118. Dr. Poling’s co-authors wrote separately to indicate that “a full disclosure of the

relationship of the patient to the lead author and the submission of the case to the Vaccine

Adverse Event Report System and the U.S. Vaccine Injury Compensation Program should have

been made to the journal prior to publication.” Exhibit 118 and exhibit H-18. The editor-in-

45

Hannah’s case met the Table’s definition of encephalopathy. Poling v. Sec’y of

Health & Human Servs., No. 02-1466V, 2011 WL 678559 (Fed. Cl. Spec. Mstr.

Jan. 28, 2011) (awarding attorneys’ fees and costs); see also R.K. v. Sec’y of

Health & Human Servs., No. 03-0632V, 2015 WL 10911950, at *14-17 (Fed. Cl.

Spec. Mstr. May 23, 2016) (describing Poling case), mot. for rev. denied, 125 Fed.

Cl. 57 (2016), aff’d, 671 F. App’x 792 (Fed. Cir. 2016).

Comparing Trystan and Hannah is difficult. To start, because Hannah was

19 months old when she received the vaccinations, she was capable of climbing

stairs, walking, and some talking. Thus, the loss of these abilities would be more

noticeable to a parent. In contrast, Trystan’s abilities as a six-month-old child

would naturally be more limited.

Even so, Hannah’s father reported to the Journal of Child Neurology that

Hannah’s abilities deteriorated in the three months after vaccination. In this time,

she became “increasingly less responsive verbally.” Within the first few weeks

after receiving her vaccination, Hannah experienced episodes of opistho-tonus

whereby she would not be able to walk up stairs normally, low-grade intermittent

fever, and generalized erythematous muscular rash. Exhibit 84 at 2.

These examples to which the Sanchezes compare Trystan are a foundation

for examining what happened to Trystan. This analysis begins with Trystan’s

health on the day of his vaccination.

1. February 5, 2009

Trystan was taken to his six-month well-baby checkup with Dr. Philip

Brown on February 5, 2009. Exhibit 1 at 44. Dr. Brown found his growth and

development to be normal. Id. at 46. As identified by Dr. Steinman as part of his

hearing testimony, normal developmental milestones for a 6-month-old include

exchanging things from one hand to another, sitting, interacting, smiling, laughing,

engaging, and cooing. Tr. 2052. Six-month milestones also include sitting up and

supporting themselves, also referred to as a “lateral prop.” Tr. 2053-54. Dr.

Brown noted that Trystan was meeting his developmental milestones, including:

turning to sound, self-feeding, self-comforting, responding to his name, sitting with

support, grasping and mouthing objects, smiling, laughing, squealing, showing

chief of the Journal of Child Neurology also stated that the authors should have disclosed

conflict of interest. Exhibit H-18.

46

interest in toys, showing differential recognition of parents, babbling reciprocally,

rolling over from back to front, and standing when placed. Exhibit 1 at 46.

Trystan also had “no head lag when pulled to sit.” Id. On this day, he received the

DTaP, hepatitis B, Haemophilus influenzae type B, inactivated polio, and

pneumococcal conjugate vaccines. Id. Dr. Brown recommended that Trystan

return in two months to receive further vaccinations. Id.; see also Ruling Finding

Facts ¶ 6.

After the wellness check with Dr. Brown, Trystan was inconsolable; he cried

a loud, high-pitched cry, as if he was in pain. Tr. 18-19, 67, 177-79. He began to

run a temperature of 102.2 degrees and developed a lump on his left thigh that was

“really hot.” Tr. 17-20, 32, 67-69, 113, 177-79. Ms. Sanchez gave Trystan

Tylenol for the fever, which ebbed and flowed over the next few days. Tr. 20, 30,

68, 151, 178, 180; see also Ruling Finding Facts ¶ 6.

From this date, three facts about Trystan are the basis for much of the

Sanchezes’ experts’ opinions. These facts are Trystan’s inconsolable crying, his

fever, and the hot spot on his thigh. Tr. 412, 420, 453. Of these three facts, the

most important is the inconsolable crying.

Inconsolable crying can be a manifestation of an encephalopathy or injury to

the nervous system. See Estep v. Sec’y of Health & Human Servs., No. 90-1062V,

1992 WL 357811, at *3 (Fed. Cl. Spec. Mstr. Nov. 3, 1992), mot. for rev. denied,

28 Fed. Cl. 664 (1993); Tr. 2020 (Dr. Steinman). Dr. Steinman, in particular, cited

to the package insert for the pertussis vaccine as a way to demonstrate that

Trystan’s crying was a manifestation of a neurologic disorder. Tr. 257, 261, 282,

2020; see also Tr. 492 (Dr. Niyazov), 873-75 (Dr. Raymond). Dr. Raymond

recognized that high-pitched crying can be compatible with an “encephalopathy,”

as defined in the Vaccine Injury Table. However, the high-pitched crying is not

diagnostic for a Table encephalopathy. Tr. 861, 918. 23

Inconsolable crying does not have to be a manifestation of a neurologic

injury. See Cox v. Sec’y of Health & Human Servs., No. 90-1673V, 1997 WL

101594, at *1 (Fed. Cl. Spec. Mstr. Feb. 18, 1997); 42 C.F.R. § 100.3(c)(2)(i)(C)

23

The relevant Table definition of “encephalopathy” required petitioners to establish that

the vaccinee suffered, among other criteria, a loss of consciousness. 42 C.F.R. § 100.3(b)(2)

(2008). Although Dr. Steinman seemed to equivocate about answering a question regarding

Trystan’s consciousness, Tr. 2036, Trystan did not suffer a loss of consciousness following the

vaccination. Tr. 859, 869, 2119.

47

(2017) (stating “high-pitched and unusual screaming” does not demonstrate an

“acute encephalopathy” as defined in the Vaccine Injury Table). As Dr. Steinman

pointed out during the December 2017 hearing, infants sometimes cry for hours

during a flight. Tr. 288. The Secretary’s experts, Dr. McGeady and Dr. Raymond,

testified that Trystan’s inconsolable crying the day of the vaccination reflected

Trystan’s discomfort and pain after receiving an injection. Tr. 729-30, 762, 872,

2141.24

Likewise, the presence of a fever is non-specific. As the October 9, 2018

decision recognized, the experts appeared to agree that vaccines can cause an

elevation in temperature and the February 5, 2009 vaccination caused Trystan’s

fever later that day. Tr. 412 (Dr. Niyazov).

The finding that the vaccine caused Trystan’s February 5, 2009 fever, which

ebbed and flowed for a few days, does not necessarily mean that Trystan

experienced a prolonged abnormal reaction to the vaccine. A fever is part of the

body’s normal physiology. Tr. 945. 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

This text is long and has been trimmed here. Open the source document for the complete record.