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 COMPENSATION1

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.
2

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-tetanusacellular 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 
3

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 
4

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 sixmonth 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 
5

(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).
6

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. 
7

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).
8

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 
9

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 

5Although 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).
10

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:
11

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 
12

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.
13

“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 
14

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 sixmonth 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. 
15

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). 
16

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.
17

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 
18

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 
19

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 
20

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. 
21

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 posthearing 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 
22

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) 
23

(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); 
24

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. 
25

In the hearing on remand, Dr. Niyazov acknowledged that he is not boardcertified 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 peerreviewed 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.
26

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 
27

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 crossexamination, 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 
28

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 1⁄2 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 
29

“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. 
30

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 
31

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 readjudication 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.
32

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 AppelleeRespondent 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). 
33

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. 
34

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 
35

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. 
36

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, 
37

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.’”).
38

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. 
39

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-
40

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 AppellantsPetitioners 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. 
41

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 
42

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. 
43

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. 
44

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’ Prehear’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 
45

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-
46

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. 
47

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. 
48

(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.”).
49

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. 
50

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 
51

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. 
52

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 crossexamining 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 
53

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. 
54

“‘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, highpitched” 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 
55

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, 
56

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 
57

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 nonseizure. 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 
58

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. 
59

Sanchez’s report that Trystan’s cousin “also had a dystonic reaction” to her oneyear-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. 
60

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-monthold 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. 
61

expert and to reject the opinion of another qualified expert strictly based on

qualifications, the undersigned would be inclined to find Dr. Raymond more 

qualified on this narrow point. Early in his career (1989-90), Dr. Raymond was a 

fellow in “developmental neuropathology.” Exhibit M (curriculum vitae) at 1. Dr. 

Steinman’s fellowship was in chemical immunology. Exhibit 168 (curriculum 

vitae) at 1. This difference in advanced specialization would break any tie in Dr. 

Raymond’s favor. 

On the more specific question as to whether Trystan experienced dystonia on 

February 16, 2009, the evidence is firmer that he did not. Both experts agree that 

dystonia originates in the basal ganglia. Tr. 2025, 2157. Before the hearing Dr. 

Raymond had written: “If Trystan were having arm contortions in February 2009 

due to Leigh syndrome and basal ganglia injury, they would have been persistent 

and obvious and it is expected that his attentive parents would have brought it to 

the attention of his providers as they did for his other illnesses.” Exhibit P at 2-3. 

Dr. Raymond’s testimony was similar. He maintained that “[i]f we look at basal 

ganglia injury for whatever reason, it typically – it typically presents initially with 

hypotonia, and it only much later presents with dystonia.” Tr. 2177. Although 

given an opportunity to address this sequence, the Sanchezes did not present any 

contrary testimony. Tr. 2177. 

Further, it seems unlikely that Trystan would experience an episode of 

dystonia that is caused by an injury in his basal ganglia one time in February 2009 

and not experience any other motor problems for months. Cf. O’Connell v. Sec’y 

of Health & Human Servs., No. 96-63V, 1998 WL 64185, at *12 (Fed. Cl. Spec. 

Mstr. Feb. 2, 1998) (deeming “arm jerking” immediately post-vaccination as not 

indicating the onset of neurological issues in part because of the lack of medical 

attention and follow-up, even where seizure activity developed weeks later), mot. 

for rev. denied, 40 Fed. Cl. 891 (1998), aff’d in unpublished op., 217 F.3d 857 

(Fed. Cir. 1999); Lara v. Sec’y of Health & Human Servs., No. 90-1655V, 1993 

WL 215068 (Fed. Cl. June 4, 1993) (a child having eye fluttering five to six times 

per days several days a week as well as “whole body jerks” from age two-months 

to four-months was found to have seizures before receiving a vaccination at age 

four-months). While Dr. Steinman states that “the dynamic effect of the shot was 

to create damage in the nervous system,” Tr. 295, and that dystonia can be 

“intermittent,” see exhibit 196 (Dr. Steinman’s June 22, 2020 report) at 2; Tr. 

2029, Dr. Steinman could not specify how frequently even “intermittent” dystonia 

appears. Tr. 2029. Dr. Steinman’s opinion suggesting that Trystan could have 

dystonia in February but not again for many months is not persuasive. 
62

Therefore, the undersigned finds that the Sanchezes have not shown by 

preponderant evidence that Trystan’s February 16, 2009 arm contortions were a 

manifestation of a seizure or an episode of dystonia. For the reasons explained 

above, the February 16, 2009 arm contortions do not constitute a neurologic 

abnormality caused by his vaccination. Because the Sanchezes bear the burden to 

establish the onset of Trystan’s neurologic injury caused by the vaccination and 

because they have not met this burden, the analysis of the arm contortions can end 

here. 

If more about the arm contortions is needed, then Dr. Raymond’s opinion is 

credible. Dr. Raymond stated, “In terms of the concerns that his arms were 

contorting, and he was jerking around, this is consistent with an uncomfortable ill 

child who is tired and does not want to be held.” Exhibit P at 2. Dr. Raymond’s 

post-remand supplemental opinion, which includes arm contortion, is in accord 

with his December 2017 testimony. Tr. 863, 874. 

Dr. Steinman stated that “‘arm contortions,’ known as dystonic posturing, 

are not associated with the common cold.” Exhibit 185 at 2; see also Tr. 460-61, 

462-63, 516 (Dr. Niyazov testifying that Trystan’s arm contortions likely 

constituted neurodegenerative events). However, the undersigned has found that 

Trystan’s February 16, 2009 arm contortions are not a manifestation of dystonic 

posturing. Although arm contortions could be a neurologic finding, Tr. 2142, they 

do not have to be. For Trystan, in February 2009, the arm contortions were not a 

manifestation of a neurologic injury. 

3. End of February to beginning of April 2009

The next period of Trystan’s life, from the resolution of his cold near the end 

of February through the beginning of April 2009, strongly influences the outcome 

of the Sanchezes’ claim for compensation. As noted above, the Sanchezes argue 

that the vaccination altered Trystan’s development. In the words of their primary 

expert, Dr. Steinman, in February 2009, Trystan took a “big hit.” Tr. 2042. 

However, as reviewed in this section, evidence of this alleged “big hit” does not 

appear in the ensuing weeks. 

Between the February 17, 2009 appointment with Mr. Luna and the April 

29, 2009 appointment with Dr. Seleem, Trystan did not see any medical providers. 

As detailed in paragraphs 12-13 of the Ruling Finding Facts, 

12. Sometime [after February 17, 2009], Trystan’s extended 

family gathered to watch a boxing match. Tr. at 25, 219. 
63

During this gathering, Trystan was sick, crying, fussy, and 

congested. Id. at 191. He was not contorting his arms nor was 

he limp or rigid. 

13. Between [Ms. Sanchez]’s birthday and the next time she 

took him to the doctor nearly two months later in late April, 

Trystan suffered from cough and congestion episodically. 

Exhibit 1 at 50. During this time, he did not lose control of his 

head and trunk, nor did he stop making eye contact or stop 

wanting to play anymore. He did not exhibit arm contortions. 

Ruling Finding Facts at 13, ¶¶ 12-13. The October 9, 2018 decision similarly 

stated that “[b]etween the February 17, 2009 visit with Mr. Luna and the April 29, 

2009 visit with Dr. Seleem, Trystan did not have any symptoms that were 

inconsistent with a cold.” Decision at 8, 2018 WL 5856556, at *4. These facts are 

not contested.35 

Neither Dr. Steinman nor Dr. Niyazov can identify any behavior in Trystan 

that shows evidence of neurodegeneration or neurologic problem between the 

February 16, 2009 cold and Trystan’s loss of skills. Dr. Niyazov was asked about 

evidence that Trystan had neurodegenerative events between February 5th and June 

1

st

. Dr. Niyazov responded: “Inconsolable crying, loud high-pitched crying, 

kicking feet and jerking around, contorting arms, and then no walking, standing --

well that’s six months.” Tr. 516. Significantly, Dr. Niyazov has identified 

behaviors that happened on February 16, 2009: “Inconsolable crying, loud highpitched crying, kicking feet and jerking around, contorting arms.” He did not 

identify another behavior in the relevant time as Trystan would not be expected to 

walk until around his first birthday. Ms. Marin-Tucker noted a delay in Trystan’s 

ability to walk; however, this was at Trystan’s May 2009 appointment, months 

later. Exhibit 1 at 54 (“[can] not walk or stand, extremities seem soft yet rigid at 

times, rolls a little, head lag, no crawling”).

In lieu of any factual findings that Trystan displayed any abnormal 

behaviors, Dr. Steinman and Dr. Niyazov attempt to excuse the lack of findings. 

To some extent, as the October 9, 2018 decision recognized, parents may not 

35 In their motion for review, the Sanchezes argued that the submission of Ms. Sanchez’s 

day planner should have altered the findings of fact. Pet’rs’ Mot. for Rev. at 3. However, the 

Court of Federal Claims rejected that argument. Opinion and Order at 250-51. The Sanchezes 

did not further pursue this argument to the Federal Circuit. 
64

notice that their child is failing to meet milestones or conceivably, parents may not 

notice that their child is losing skills he once had. Decision at 27, 2018 WL 

5856556, at *16; see also Tr. 313 (Dr. Steinman commenting on observations). 

However, according to Dr. Raymond, a child with damaged basal ganglia is likely 

to have low tone and maybe abnormalities in eye movement or breathing issues. 

Tr. 2127. However, there is no persuasive evidence of abnormal eye movements 

or hypotonia from the end of February for many weeks. 

Alternatively, the Sanchezes maintain that Trystan experienced a “fade” 

response as described in the Naviaux commentary to the Shoffner article. See

Pet’rs’ Remand Br. at 51-53. For this argument, the Sanchezes primarily rely upon 

Dr. Niyazov’s testimony, although Dr. Steinman similarly suggested that the 

progression of Trystan’s condition might stop and stutter. Tr. 298. 

Preliminarily, the value of the Naviaux commentary is uncertain. The 

account that Dr. Niyazov presented came from a blog of the website for the group 

Autism Speaks. See exhibit 68 (Dr. Niyazov’s report) at 13 (bibliography); Bob 

Naviaux, Commentary on Fever Plus Mitochondrial Disease Could Be Risk 

Factors for Autistic Regression by Shoffner et al., filed as exhibit 80. Dr. Niyazov

did not know whether the Naviaux commentary was peer-reviewed. Tr. 526. 

While the lack of peer review could diminish the value of opinions expressed, Dr. 

Niyazov vouched for Dr. Naviaux’s credentials, describing Dr. Naviaux as a “very 

trusted and respected person, an expert in the field of mitochondrial disease.” Tr. 

526. A second issue is that the underlying Shoffner article and Naviaux 

commentary are written about children with autism, which is not Trystan’s disease. 

See Tr. 310, 833-34; see also H.L. v. Sec’y of Health & Human Servs., No. 10-

0197V, 2016 WL 3751848, at *17 (Fed. Cl. Spec. Mstr. Mar. 17, 2016) 

(petitioner’s witness “admitted that she is not aware of any reliable study 

attributing acute metabolic decompensation to a flu vaccine among patients with 

Leigh Disease”), mot. for rev. denied, 129 Fed. Cl. 165 (2016), aff’d, 715 F. App’x 

990 (Fed. Cir. 2017). But, this issue, too, can be set aside to address the substance 

of the argument that Trystan faded. 

Dr. Naviaux stated “[w]hen children with the common forms of 

mitochondrial disease suffer a regression, it is most often a ‘fade’ response. The 

fade response is typically delayed for 2-10 days after a fever resolves.” Exhibit 80 

(Naviaux) at 2 (underline in original). Based upon reports from parents, Dr. 

Naviaux describes the fade response: “the child was getting better from their cold 

or flu, when suddenly, their consciousness fades. The child can become difficult to 

fully awaken, or will stop walking, stop talking, stiffen or lose muscle tone, or 

have a seizure, or a stroke-like episode.” Id. The Sanchezes state in multiple 
65

places that Trystan suffered a fade response. See, e.g., Pet’rs’ Remand Br. at 37, 

52. The Sanchezes rightfully point out that Trystan had not yet developed the 

ability to walk or to talk. 

However, there is not preponderant evidence that Trystan experienced a fade 

as Dr. Naviaux has described. There is no evidence that in the months after his 

February 5, 2009 vaccination, Trystan began to lose consciousness or was difficult 

to awaken. In contrast, the Ruling Finding Facts found that Trystan continued to 

play. Similarly, there appears to be no evidence that between February 17, 2009, 

and at least May 1, 2009, that Trystan suffered a seizure or stroke-like episode. 

Trystan did have arm contortions on February 16, 2009. But, that episode was 

short-lived, singular, and did not signify a neurologic injury due to vaccination. 

The Ruling Finding Facts found that during a boxing match the family watched 

after February 17, 2009, Trystan was neither limp nor rigid. Therefore, the 

argument that Trystan is like the children reported in the Naviaux commentary 

advanced by Dr. Niyazov is inapt. 

So, too, are comparisons between Trystan and Karl Paluck. By way of 

review, approximately 2-3 weeks after vaccination, Karl experienced such 

worsened stiffness in his limbs that his parents took him to a chiropractor for 

several visits. Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1376 

(Fed. Cir. 2015). In the ensuing months, Karl’s pediatric neurologist noted that 

Karl suffered from “gross motor delay, global developmental delay, and 

hypertonicity.” Id. A later MRI confirmed a thinning of the corporal collosum. 

Id. Karl suffered seizures and was later diagnosed with an unspecified 

mitochondrial disorder. Id. Trystan did not manifest a progression of stiffness in 

his limbs for which his parents sought medical attention. 

While the Sanchezes have also compared Trystan to Hannah Poling, that 

analogy does not hold true. Dr. Naviaux pointed to Hannah Poling as an example 

of the “flare” response. As weak as the evidence that Trystan suffered a fade is, 

any claim that Trystan suffered a flare is even weaker. Dr. Naviaux describes a 

flare as “occur[ing] early, at the peak of the fever and inflammatory response, 

within 2-3 days of infection. During a flare response, there is a high fever, often 

over 102⸰F, and hyperirritability, crying, inconsolability, a disrupted sleep-wake 

cycle, and a refusal to walk in children who might otherwise appear physically able 

to walk.” Exhibit 80 (Naviaux) at 2 (underline in original). “Following a flare 

response, there can be a gradual evolution of other problems from persistent GI 

problems and diarrhea, a gradual loss of language over 2-3 months, with the onset 

of repetitive movements, to gaze avoidance and social avoidance. It must be 

emphasized that a flare response is not simply a high fever, or even a dramatic 
66

reaction to a high fever, like a febrile seizure.” Id. Except for inconsolable crying 

and fever, Trystan did not have problems such as a disrupted sleep-wake cycle, 

gastrointestinal problems, or social avoidance. 

In sum, Trystan did not present like any of the children to whom the 

Sanchezes have compared him.36 The undersigned recognizes that Trystan does 

not have to match any of these prior cases. On the other hand, the prior cases do 

start to form a tentative pattern in which children who may have been harmed by a 

vaccination show evidence of decline within a few weeks of the vaccination. The 

evidence of decline might “ebb and flow.” Tr. 460. But, even a progression that 

ebbs and flows has some periods in which the child displays some worsening 

symptoms. Here, Trystan did not. 

Implications for Althen Prong 3

As discussed earlier, Althen prong 3 requires (a) persuasive evidence about 

the timeframe between a vaccination and the onset of a problem for which 

inferring causation is appropriate and (b) persuasive evidence that the onset 

occurred in that time. The undersigned has found that the evidence tends to 

suggest that the expected interval is around two weeks, although this period cannot 

be rigidly defined. 

Within two weeks, Trystan did experience two episodes. First, on the day 

and night of vaccination, he experienced a fever, inconsolable crying, and a mark 

on his leg. Second, approximately 11 days later, Trystan had a common cold. In 

association with this cold, Trystan experienced a fever, congestion, restlessness, 

jerking around, and arm contortions. Taken in isolation, each seems to be a 

relatively benign, if not typical, part of infancy. 

However, as Dr. Steinman stated, context matters. Tr. 257, 265, 325, 2019, 

2057. If, in the following weeks and months, Trystan had displayed neurologic 

problems, such as spasticity for which his parents sought treatment like Karl 

Paluck or the consistent eye blinking of Ashlyn Markovich, then the relatively 

benign episodes could be viewed in context as more significant. But, Trystan did 

not display any behaviors that suggested any neurologic problems from February 

17, 2009, to at least May 1, 2009, well beyond the approximate two-week onset of 

36 In the context of genetics, Dr. Niyazov accused Dr. Raymond of “cherry-picking” 

cases that support Dr. Raymond’s opinion. Tr. 2162. But, the comparisons offered in the text 

are comparisons from cases and articles that the Sanchezes have offered. 
67

symptoms anticipated by the Sanchezes’ medical theory. Consequently, the 

Sanchezes have failed to meet their burden of proof regarding prong 3.

37

4. April to May 2009

As previously described, from the end of February through approximately 

mid-April, Trystan experienced relatively good health. He did have episodes of 

coughing and congestion occasionally. Ruling Findings Fact, issued April 10, 

2013, ¶ 13. 

On April 29, 2009, when pediatrician Dr. Nabil R. Seleem saw 

Trystan, then eight and a half months old, he noted that Trystan 

had suffered cough and congestion for two weeks. No unusual 

arm movements or developmental issues were reported. In his 

neurological review, Dr. Seleem noted “[n]o neurological 

symptoms.” Ultimately, he diagnosed Trystan with an ear 

infection and bronchitis and prescribed amoxicillin. Exhibit 1 

at 50-52.

Ruling Finding Facts ¶ 14. Additionally,

Dr. Seleem did not observe any signs consistent with a 

neurological injury during the examination performed on 

Trystan during the April 29, 2009 visit. Instead, Trystan had a 

cold.

Decision at 8, 2018 WL 5856556, at *4.

Trystan’s mother and grandmother brought Trystan back to the 

clinic to see Dr. Brown on May 13, 2009. Dr. Brown observed 

that Trystan’s infection appeared to be resolving, and 

recommended continued use of a humidifier. No reports of the 

loss of eye contact or an inability to roll over were made at this 

time. Exhibit 1 at 53. 

Ruling Finding Facts ¶ 15.

37 To be clear, in determining that the Sanchezes have not met their burden regarding 

prong 3, the undersigned has not considered the effect of the colds for which Trystan was treated 

on April 29, 2009, and May 13, 2009. 
68

As noted in the October 9, 2018 decision, Dr. Steinman and Dr. Niyazov

largely ignored the visits with Dr. Seleem and Dr. Brown. This oversight is most 

readily apparent in demonstrative exhibits used during Dr. Steinman’s and Dr. 

Niyazov’s testimony. See exhibits 162 and 165; see also Tr. 338-39 (Dr. 

Steinman’s testimony in reference to exhibit 162), 458-59 (Dr. Niyazov’s 

testimony in reference to his timeline). Both demonstrative exhibits omit a 

summary of these visits on their timelines. 

Other examples of Dr. Steinman and Dr. Niyazov skipping over the visits for 

colds appear as well. Dr. Niyazov testified: “We can only follow February 5th and 

16th and August 8

th and June 1st.” Tr. 462. This list does not include observations 

from Dr. Seleem and Dr. Brown.

In the hearing on remand, when asked for the next data point along Trystan’s 

“downward cascade” following the February 16-17, 2009 episode, Dr. Steinman 

pointed to the second set of vaccinations, which occurred in August 2009. Tr. 

2035-36. Similarly, early in Dr. Steinman’s testimony during December 2017, he 

described Trystan as a “healthy well child and following that February 5th

immunization and then even more dramatically after the August -- mid August 2nd 

encounter that we call response, he had neurologic deterioration.” Tr. 292. 

Similarly, Dr. Steinman stated: “there’s no doubt it began February 5th, it 

worsened in mid August.” Tr. 293. 

A question from the Sanchezes’ attorney also shows how Dr. Steinman

minimized the illnesses: 

Q: If Trystan had a couple colds between February 16 and June 

1, would that impact your opinion regarding this continuous 

process?

A: No. I mean, children in the winter are going to get 

respiratory infections, so it’s the unusual child who would not 

have that.

Tr. 298. The question is posed as a hypothetical but there is no dispute that 

Trystan had colds in the relevant time. 

Dr. Steinman’s dismissal of the sicknesses is inconsistent with his later 

testimony that “infections . . . can devastate or kill” children with mitochondrial 

diseases. Tr. 312; accord Tr. 2044. Later, in response to a question from the 

undersigned, Dr. Steinman recognized that infections could contribute to Trystan’s 
69

Leigh’s syndrome but the infections did not because Trystan did not have a fever. 

Tr. 360-61. Dr. Steinman repeated this opinion in the remand hearing in which he 

stated that “small” colds would not affect Trystan. Tr. 2043-44. 

Dr. Niyazov also admitted that “if anything comes in in the meantime 

[referring to the period between February 16, 2009, and the loss of skills on June 1, 

2009] and hits the child’s system again, like a fever of 103, . . . then that will 

contribute to that fade response.” Tr. 459; accord Tr. 2076. Dr. Niyazov did make 

some attempt to fit the colds into his overall theory of the case by stressing 

Trystan’s vulnerability, as evidenced by the following exchange during the original 

entitlement hearing: 

Q: Now, if there were some other illnesses between February 

16th and June 1st, what impact would those have on Trystan 

who’s now more susceptible and his energy levels are ebbing 

and flowing, if I’m hearing that correctly?

A: Right. So there will be -- it will have a detrimental effect 

and it will decrease the energy further and, at some point, he 

would start losing skills.

Tr. 460; accord Tr. 2076. 

The undersigned recognizes that in Dr. Steinman’s and Dr. Niyazov’s view, 

Trystan started a decline on February 5, 2009. Thus, they could reasonably assert 

that the colds in April and May only contributed to an on-going process. The flaw, 

however, is that, for the reasons explained at length above, the Sanchezes have not 

presented persuasive evidence that Trystan’s decline started on February 5, 2009. 

See Tr. 2124 (Dr. Raymond). 

Instead, if Trystan did not start a neurologic decline until May 1, 2009, at the 

earliest—as the October 9, 2018 decision finds and this decision confirms—then 

the analysis proceeds differently. If it is assumed for the sake of argument that a 

trigger, such as an upper respiratory infection, could influence the outcome of a 

child with Trystan’s genetic mutations, then the infection is a more likely trigger 

for the neurologic decline. The sequence of events fits much better. On April 29, 

2009, Ms. Sanchez reported that Trystan had been ill for two weeks. Exhibit 1 at 

50-52. Then, Trystan started to lose developmental skills perhaps as early as May 

1, 2009, which would be approximately two weeks after he became infected. At 

the August 17, 2009 primary care visit, Ms. Marin-Tucker noted certain 

developmental delays and loss of skills that Ms. Sanchez reported began occurring 
70

“2-3 months ago” (i.e., around May 17, 2009, or June 17, 2009). Id. at 54. This 

loss of skills included “[can] not walk or stand, extremities seem soft yet rigid at 

times, rolls a little, head lag, no crawling, . . . can [not] sit or grasp.” Id. Ms. 

Marin-Tucker also noted “speech and language deficits” and “developmental 

delays.” Id. 

As discussed in the context of prong 3, Edmonds and Shoffner suggest that 

an appropriate interval to infer causation is approximately two weeks between the 

inciting event and the onset of decline. Edmonds and Shoffner, therefore, align 

with an account that Trystan’s neurodegeneration began around May 1, 2009. But, 

to repeat, the foregoing analysis assumes that a trigger is needed. Thus, assuming 

this medical theory and, in light of Trystan’s May 2009 onset of

neurodegeneration, it is more likely that Trystan’s infections between February and 

May 2009 caused the manifestation of his Leigh’s syndrome, independent of his 

vaccinations. 

5. August 2009

The following facts were established in the Ruling Findings Fact:

19. At [Ms. Sanchez]’s baby shower, on August 8, 2009, 

Trystan exhibited inconsolable crying. Tr. 25, 45-46, 88-89, 

137, 159. At times, instead of being rigid, his body was limp, 

as if he had no muscle tone. Id. at 46, 53. At other times 

during this day, he was contorting his arm. Id. at 89, 137, 160. 

20. At one year old, Trystan was seen by Physician Assistant 

Micaela Marin-Tucker for a well-child exam. Exhibit 1 at 54-

56; Tr. 89-90. Ms. Sanchez informed Ms. Marin-Tucker that 

she “noticed a change in [Trystan’s] development about 2-3 

months ago38 but since she had taken [Trystan to the pediatric 

clinic] with Dr. Brown she thought that everything was ok.”39 

38 According to this report, Trystan’s developmental changes began between May 17, 

2009, and June 17, 2009.

39 Ms. Sanchez testified that she had reported to Ms. Marin-Tucker that Trystan’s 

developmental changes began five to six months before his August 17, 2009 visit, which would 

be between February 17, 2009, and March 17, 2009. Tr. 90-91. Ms. Sanchez’s August 17, 2009 

recounting of the onset of Trystan’s developmental delays is more reliable than testimony 

offered more than two years after his visit to Ms. Marin-Tucker. Testimony offered so long after 
71

Exhibit 1 at 54. (This history is the basis for the conclusion in 

paragraph 18 that Trystan’s loss of skills began around June 1, 

2009.) Upon a review of systems, Ms. Marin-Tucker found that 

Trystan did not walk, stand, crawl, and hold his head up while 

sitting, or make any attempt to move his lower extremities. She 

also noted in her examination that his extremities seemed soft, 

yet rigid at times. As the result of her examination, Ms. MarinTucker ordered a battery of lab tests. Exhibit 1 at 54-55. She 

also referred Trystan to a neurologist, physical therapist, and 

occupational therapist. Id. at 55; Tr. 90. Additionally, Trystan 

received his third hepatitis B vaccine, as well as his second 

doses of the pneumococcal conjugate, DTaP, and Hib vaccines. 

Exhibit 1 at 55; Tr. 92. Trystan was to return to the nurse the 

next week to receive the remaining vaccinations that were due, 

including the measles, mumps, and rubella, varicella, and 

hepatitis A vaccines. Exhibit 1 at 55.

Ruling Findings Facts ¶¶ 19-20. 

Before considering how Trystan fared after his second set of vaccinations, 

Trystan’s developmental status on the day he received his second set of 

vaccinations should be established. Some information about Trystan’s health 

before the second set of vaccinations comes from his family’s testimony about his 

behavior during the baby shower on August 9, 2009. 

This testimony credibly established that Trystan lacked muscle tone and was 

having arm contortions. Trystan’s behavior appears to fit how Dr. Raymond 

asserted that problems originating in the basal ganglia would present: first with 

hypotonia and later with dystonia. See Tr. 2177. Furthermore, a decline starting in 

May or June through August 17, 2009, would be consistent with Dr. Naviaux’s 

fade response. Tr. 833 (Dr. Raymond). 

Otherwise, the experts did not focus too much on Trystan’s developmental 

status just before August 17, 2009. Dr. Steinman recognized that by the date of 

Ms. Marin-Tucker’s examination, Trystan’s loss of skills had been going on for 

some time. Tr. 296-97; see also Tr. 2124 (Dr. Raymond). Rather, Trystan’s status 

the events in question is less reliable than reports provided closer in time, when the motivation 

for accurate explication of symptoms is more immediate.
72

on the day of his second set of vaccinations forms a foundation for the argument 

that Trystan experienced a rechallenge. 

6. October – December 2009, including Rechallenge

Information about Trystan’s development following his August 17, 2009 

vaccinations is scarce. The Ruling Findings Facts stated: 

21. About six weeks [after the August 17, 2009 vaccination], on 

October 7, 2009, both Jennifer and Germain went to see Ms. 

Marin-Tucker for a follow-up. In a review of Trystan’s 

systems, Ms. Marin-Tucker noted no seizures, weakness, or 

tics. She made no notation of tremors or twitching. Upon 

neurologic examination, she found Trystan to be unable to 

grasp, sit, crawl, or make much eye contact. Germain reported 

that there was “another child in the family with the same 

symptoms and doctors [could] find nothing wrong.” Ms. 

Marin-Tucker emphasized the importance of making the 

appointment with a neurologist as soon as possible. Exhibit 1

at 57-58.

Ruling Finding Facts ¶ 21. This statement also appears in the October 9, 2018 

decision. 

Based upon Ms. Marin-Tucker’s notes from two appointments, Dr. Steinman 

characterized this “as a worsening of [Trystan’s] neurologic condition” after his 

second vaccinations. Tr. 336. This conclusion is reasonable. However, the 

ensuing question is whether the Sanchezes have established that the challengerechallenge paradigm fits this case. 

Evidence of challenge-rechallenge can be powerful evidence in support of a 

claim that a vaccine harmed an individual. See Koehn v. Sec’y of Health & 

Human Servs., No. 11-355V, 2013 WL 3214877, at *30 (Fed. Cl. Spec. Mstr. May 

30, 2013), mot. for rev. denied, 113 Fed. Cl. 757 (2013), aff’d, 773 F.3d 1239 

(Fed. Cir. 2014). “A rechallenge event occurs when a patient who had an adverse 

reaction to a vaccine suffers worsened symptoms after an additional injection of 

the vaccine.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1322 

(Fed. Cir. 2006). To this basic definition, Dr. Raymond added that “[t]he 

challenge should meet the criteria of same latency and same effects, and must 

exclude well-accepted alternative explanations.” Exhibit P at 4. 
73

The Sanchezes criticize Dr. Raymond for not adopting the “legal definition” 

of rechallenge. Pet’rs’ Remand Br. at 38 n.15. However, to the extent that Dr. 

Raymond is promoting the idea that the challenge and the rechallenge events 

should be similar or the same, this concept has appeared in other cases from a 

variety of sources. See, e.g., R.V. v. Sec’y of Health & Human Servs., No. 08-

504V, 2016 WL 3882519, at *19 n.62 (Fed. Cl. Spec. Mstr. Feb. 19, 2016) (relying 

upon Dr. Shafrir), mot. for rev. denied, 127 Fed. Cl. 136 (2016), app. dismissed, 

Fed. Cir. 16-2400 (Oct. 26, 2016); Tompkins v. Sec’y of Health & Human Servs., 

No. 10-261V, 2013 WL 3498652, at *27 n.68 (Fed. Cl. Spec. Mstr. June 21, 2013) 

(citing report from Institute of Medicine), mot. for rev. denied, 117 Fed. Cl. 713 

(2014); Freeman v. Sec’y of Health & Human Servs., No. 04-1528V, 2009 WL 

5103594, at *12 (Fed. Cl. Spec. Mstr. Dec. 9, 2009) (relying upon opinion of Dr. 

Sundel and report from Institute of Medicine); Tosches v. Sec’y of Health & 

Human Servs., No. 06-192V, 2008 WL 440285, at *7 (Fed. Cl. Spec. Mstr. Jan. 31, 

2008) (relying upon testimony of Dr. McCusker); Stevens v. Sec’y of Health & 

Human Servs., No. 99-594V, 2006 WL 659525, at *14 (Fed. Cl. Spec. Mstr. Feb. 

24, 2006) (testimony of Prof. Dunbar). The relative resemblance of the two events 

would seem to contribute to the strength of the challenge-rechallenge paradigm. 

For example, if a person developed a rash one week after receiving one vaccine 

and if the person had a seizure one week after receiving the second dose of this 

vaccine, the rash and seizure might have different etiologies. 

Dwelling on the nuanced points of challenge-rechallenge seems unnecessary 

in this case. The Sanchezes have not established the challenge aspect. As 

explained above, the Sanchezes have not presented preponderant evidence that 

Trystan suffered any neurologic problem within at least one month of the February 

5, 2009 vaccine. And, by simple definition, without a “challenge,” there can be no 

“rechallenge.” 

Moreover, to the extent that similarity in reaction can be considered in an 

analysis of challenge-rechallenge, the Sanchezes’ argument weakens even further. 

The Sanchezes have alleged that following the first DTaP vaccination, Trystan 

reacted acutely by crying inconsolably, running a fever, and developing a red spot 

on his thigh. But, there appears to be no persuasive evidence that Trystan suffered 

any type of acute reaction to the second DTaP vaccination. The Sanchezes have 

not offered any explanation for why an agent that produced (in their view) a sharp 

response on Trystan’s first encounter would produce a much different response on 

the second encounter. 
74

In advancing their challenge-rechallenge argument, the Sanchezes have cited 

reports from doctors who obtained histories about Trystan much later. See Pet’rs’ 

Remand Br. at 32-33 (citing exhibit 1 at 196 (Dr. Friedman’s August 2, 2010 

report) and exhibit 26 at 8 (Dr. Haas’s March 26, 2013 report)). A more detailed 

analysis of the reports from some treating doctors, including Dr. Friedman and Dr. 

Haas, is deferred until section VII.C below. However, the undersigned has 

considered Dr. Friedman’s and Dr. Haas’s statements in finding that the Sanchezes 

have not met their burden of proof with respect to challenge-rechallenge. 

Although Ms. Marin-Tucker observed that Trystan lost developmental abilities in 

her appointment on October 7, 2009, that decline does not automatically constitute 

a rechallenge. 

The Ruling Finding Facts memorializes the next events in Trystan’s history. 

It states: 

22. Between October 7, 2009, and his neurology visit on 

November 12, 2009, Trystan began having “tremors” or 

“twitching” of his whole body. Tr. at 199-200; Exhibit 1 at 

140.

23. On November 12, 2009, Trystan was taken to see Dr. David 

J. Michelson, the neurologist to whom he was referred. Dr. 

Michelson recorded reports that Trystan was unable to sit 

independently, his hands stayed closed, and his feet went 

forward when at rest. He noted that, at times, Trystan could 

hold his mouth open tightly and drool, but at other times he 

could chew and swallow well. While Trystan had previously 

held his right arm stiffly behind him episodically, he had not 

done this lately. Dr. Michelson’s review of systems was 

positive for muscle spasms, global developmental delay, 

weakness, walking problems, constipation and birthmarks. 

Dr. Michelson noted that Trystan suffered from “global 

developmental delay of unclear etiology, though a genetic 

predisposition is suspected based on the family history and a 

[central nervous system] cause is suggested by the physical 

exam findings.” Exhibit 1 at 140-41. 

Ruling Finding Facts ¶¶ 22-23. Dr. Michelson ordered an MRI, which Trystan 

underwent in December 2009. The MRI showed problems in Trystan’s basal 

ganglia. Exhibit 1 at 142; see also id. at 130 (reinterpretation of same study). A 
75

problem in the basal ganglia is often found in people suffering from Leigh’s 

syndrome. See Tr. 407, 2126. 

The doctors spent several years trying to determine what condition was 

afflicting him. Finally, during this litigation, the Sanchezes obtained genetic 

testing for Trystan. Exhibits 53 and 59. These tests showed that Trystan suffered 

two mutations. Whether these mutations caused Trystan’s Leigh’s syndrome is 

discussed in section VIII below. 

In sum, this section B has considered both how the Sanchezes’ experts 

predicted an adverse reaction to the vaccination would appear and how Trystan 

actually appeared. Because of the dichotomy between the predicted and the actual, 

the sequence of events is not logical. Thus, the Sanchezes have not met their 

burden regarding prong 2. 

C. Treating Doctors

With respect to Althen prong 2, the Federal Circuit has instructed special 

masters to consider carefully the views of a treating doctor. Capizzano v. Sec’y of 

Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). However, the 

views of a treating doctor are not absolute. Snyder v. Sec’y of Health & Human 

Servs., 88 Fed. Cl. 706, 745 n.67 (2009). 

The Sanchezes argue that treating doctors have indicated that the vaccination 

caused Trystan’s problems. They list four doctors. Pet’rs’ Remand Br. at 29. For 

the reasons explained below, they overstate the significance of these reports. 

Dr. Friedman. In 2010 and 2011, Dr. Friedman stated that Trystan might 

have acute disseminated encephalomyelitis. Thus, she suggested that Trystan 

could have “ADEM secondary to vaccine” and “other vaccine toxicity.” Exhibit 

10 at 7 (Sept. 6, 2011).40 

If Trystan suffered from ADEM, then Dr. Friedman’s opinion could be quite 

valuable. However, Trystan does not have ADEM. Genetic testing shows that he 

has Leigh’s syndrome. Thus, Dr. Friedman’s report does not advance the 

Sanchezes’ claim that the vaccinations contributed to Trystan’s Leigh’s syndrome. 

40 DTaP and other vaccines have been found to cause ADEM. E.g., Lerwick v. Sec’y of 

Health & Human Servs., No. 06-847V, 2011 WL 4537874 (Fed. Cl. Spec. Mstr. Sept. 8, 2011). 
76

Dr. Sharma. Akhil Sharma saw Trystan for a new well-child examination on 

October 2, 2013. Exhibit 137 at 1. Under “past medical history,” Dr. Sharma has 

recorded that Ms. Sanchez told him Trystan “Did well till 6 mo. Got 6 mo shots 

for the first time and got fever and seizures [after] that followed by regression of 

milestones.” Id. This “past medical history” concludes: “probable vaccine 

induced injury.” Id. Dr. Sharma repeats this history in his June 26, 2015 medical 

record. Id. at 8. 

Dr. Sharma’s reports carry little persuasive value. The record appears to 

reflect Ms. Sanchez’s account of the events in Trystan’s life as opposed to Dr. 

Sharma’s evaluation. Even within Ms. Sanchez’s recollection, Ms. Sanchez seems 

to indicate that following the vaccinations when Trystan was six months, Trystan 

had a “fever and seizures.” While Ms. Sanchez may sincerely believe that Trystan 

had a seizure on the night of February 16, 2009, the record does not persuasively 

establish that a seizure happened then. Thus, to the extent that Dr. Sharma reached 

an opinion that Trystan had a “probable vaccine induced injury,” Dr. Sharma’s 

conclusion seems to derive from an erroneous starting point. As such, the 

undersigned gives Dr. Sharma’s opinion about the cause of Trystan’s neurologic 

problem little weight. See Dobrydnev v. Sec’y of Health & Human Servs., 566 F. 

App’x 976, 983 (Fed. Cir. 2014) (noting special master may reject the testimony of 

a doctor who examined the vaccinee when the doctor receives an inaccurate 

history); Castaldi v. Sec’y of Health & Human Servs., 119 Fed. Cl. 407, 416 

(2014) (determining that special master was not arbitrary in considering that the 

reports from a treating doctor “were largely based on [the petitioner’s] recollection 

rather than [the doctor’s] own observations”); Balasco v. Sec’y of Health & 

Human Servs., No. 17-215V, 2020 WL 1240917, at *21 (Fed. Cl. Spec. Mstr. Feb. 

14, 2020) (rejecting statements from treating doctors about diagnosis when the 

treaters relied upon history that was not correct).

Dr. Haas. Dr. Haas first saw Trystan on August 7, 2012. Exhibit 26 at 1. 

The date of this first visit was approximately three months after the onset hearing 

at which Trystan’s family members testified. The history that Dr. Haas obtained is 

similar to the testimony the family provided during that hearing. Dr. Haas 

recorded: 

Trystan was perfectly normal until 6 month vaccines. Parents 

report he was saying mama, dada and supporting weight on his 

legs at that time. Parents didn't do 2 month or 4 month shots, 

then showed up for 6 month vaccines at 5 mo of age. (at this 

visit noted to have normal development, rolling back to front 
77

and standing when placed, passing objects hand to hand and 

rake sand grasping small objects, sitting with support, no head 

leg [sic “lag” may have been intended] with pull to sit) Got his 

shots, then shortly developed fever and cranky. Then developed 

congestion (1-2 weeks after). Were giving him Tylenol. Saw 

PMD, Dx otitis media, gave Amox. The fever persisted and he 

had inconsolable crying. 11 days after the vaccination, he had 

an episode of ‘contortion’ in the upper limbs. He would stiffen 

his arms behind his back, he would jerk his arms and his neck, 

sometimes at same time, sometimes one after another. No loss 

of consciousness. Would do this minutes at a time. Dad would 

try to straighten his arms but they would snap back. He would 

do this when awake and asleep. No post-ictal.

Exhibit 26 at 1. With respect to immunizations, Dr. Haas recorded: “Not up to

date. . . . Got sick (cough, fever, congestion) right after his second set, and then 

started having seizures.” Id. at 2. After obtaining additional information and 

conducting a physical exam, Dr. Haas assessed Trystan: 

Trystan is a 4 year old boy who had acute onset regression and 

dystonia at 6 months of age, following vaccination, which 

repeated with the next set of vaccines at 12 months.[41] The

developmental regression reached a plateau soon after, and he is 

making some developmental progress ever since. The dystonia 

persists, with truncal hypotonia. He has basal ganglia

abnormalities on his MRI scan, and abnormally raised CoQ and 

Complex IV in his muscle. The next step would be for his 

muscle to be sent for mtDNA sequencing. We will search for

stored muscle. 

Id. at 3. 

41 The basis for Dr. Haas’s statement that something “repeated with the next set of 

vaccines at 12 months” is not readily apparent as the history that Dr. Haas obtained does not 

refer to anything happening after Trystan’s vaccinations at 12 months. 
78

The Sanchezes emphasize that Dr. Haas wrote that the onset of Trystan’s 

regression and dystonia came “following vaccination.” Pet’rs’ Remand Br. at 29.42 

Dr. Haas retained this wording in subsequent records as well. See exhibit 26 at 8 

(Mar. 26, 2013); exhibit 52 at 1-2 (June 10, 2014). 

On its face, a statement that the illness occurred “following vaccination” 

presents a sequence of events. The recitation of a chronological sequence of 

events is not the same as an opinion regarding causation. See Cedillo v. Sec’y of 

Health & Human Servs., 617 F.3d 1328, 1347-48 (Fed. Cir. 2010); La Londe v. 

Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 206 (2013), aff’d on other 

ground, 746 F.3d 1334 (Fed. Cir. 2014); Langland v. Sec’y of Health & Human 

Servs., 109 Fed. Cl. 421, 439 (2013) (stating that the special master was not 

arbitrary in finding that the records from treating doctors “reflect no more than 

intake histories or temporal associations”); Caves v. Sec’y of Health & Human

Servs., 100 Fed. Cl. 119, 139-40 (2011), aff’d without op., 463 F. App’x 932 (Fed. 

Cir. 2012). 

Furthermore, these three statements from Dr. Haas came before the genetic 

mutations in Trystan were discovered. After the genetic mutations were identified, 

Dr. Haas wrote a letter to other medical providers. Dr. Haas told Trystan’s other 

doctors that “Trystan Evan Sanchez has a mitochondrial disease caused by 

Complex II deficiency of the respiratory chain. This is a genetic disease causing in 

Trystan dystonia, developmental delay, encephalopathy, neuromuscular 

disease[, and an] abnormal MRI.” Exhibit 62 at 6. Here, Dr. Haas does not state 

that the cause of Trystan’s disease was the vaccination. 

Yet, Dr. Haas does not completely ignore the vaccinations. In a September 

24, 2019 report, Dr. Haas stated that Trystan has “Leigh’s disease due to complex 

II deficiency . . . This boy’s mitochondrial disease is life threatening and he can 

deteriorate with stress situations including the possibility of fever after 

immunization. For this reason it is medically acceptable for him to avoid 

immunizations.” Exhibit 184 at 53. 

A recommendation to avoid vaccinations is not necessarily the same as a 

statement that a vaccine caused an injury. See Moberly v. Sec’y of Health & 

Human Servs., 85 Fed. Cl. 571, 604-05 (2009), aff’d, 592 F.3d 1315 (Fed. Cir. 

42 The Sanchezes also cite exhibit 53. However, exhibit 53 is not a report from Dr. Haas. 

Exhibit 53 is a GeneDx report, dated November 5, 2014. 
79

2010); Rickard v. Sec’y of Health & Human Servs., No. 09-729V, 2011 WL 

1979601, at *12 (Fed. Cl. Spec. Mstr. Apr. 11, 2011) (indicating that the doctor 

recommended avoiding future vaccinations as part of a standard practice). 

Dr. Wong. Upon referral from Dr. Sharma, Derek Wong from the 

Children’s Hospital of Los Angeles, division of medical genetics, saw Trystan on 

January 28, 2016. In his history, Dr. Wong states that he is quoting a record from 

Dr. Haas: 

He had vaccines at five months of age, then had fever and 

irritability. He developed congestion, and had a fever and otitis 

[media]. 11 days after the vaccines, he had stiffening episodes 

that lasted for 18 months.[43] After this episode, he lost head 

control but regained it 1-2 months later. 

Exhibit 139 at 1. The history in Dr. Wong’s report continues: 

At 12 months of age, Trystan had some intermittent rigidity of 

his extremities, head lag, and significant developmental delay. 

[Ms. Sanchez] told me that he had vaccines at 12 months of age 

that caused further developmental regression although I am 

unclear on the sequence of events after reading Dr. Haas’s 

notes. That note states that the patient had cough, fever, and 

congestion after his 12 month immunizations, and that seizures 

started after that point. 

Id. at 1.44

Dr. Wong reviewed the results from other tests including the whole exome 

sequencing showing the c.667delG and c.1571C>T mutations. According to Dr. 

Wong, “[t]herefore the diagnosis of complex II deficiency secondary to SDHA 

mutations was made, and specifically Leigh syndrome.” Id. at 2. When Dr. Wong 

reviewed Trystan’s immunization status, Dr. Wong recorded: “Immunizations are 

43 The basis for Dr. Wong’s January 2016 statement that Trystan had stiffening for 18 

months is not readily apparent. 

44 Rather than quoting Dr. Haas’s records, Dr. Wong appears to be significantly 

paraphrasing the records. See exhibit 26 at 1-2.
80

not up to date. Note possible reactions to vaccines – developmental regression.” 

Id. at 3. 

All this description of Trystan’s condition precedes the passage that the 

Sanchezes quote. Pet’rs’ Remand Br. at 75. In Dr. Wong’s assessment, he states 

Trystan’s “manifestations include developmental regression, following vaccines 

and/or viral syndrome.” Exhibit 139 at 5. However, the Sanchezes do not point 

out that in the previous sentence, Dr. Wong wrote, “Trystan is a 7 year old male 

with mitochondrial complex II deficiency secondary to compound heterozygous 

mutations in the succinate dehydrogenase A (SDHA) gene.” Id.

Dr. Wong’s record provides little assistance to the Sanchezes. At best, like 

Dr. Haas and Dr. Sharma, Dr. Wong recognizes a temporal sequence in which 

Trystan’s developmental regression “follow[ed] vaccines and/or viral syndrome.” 

But, even this statement from Dr. Wong must be placed in the context in which Dr. 

Wong describes Trystan’s developmental regression as a “manifestation” of a 

“mitochondrial complex II deficiency secondary to compound heterozygous 

mutations.” 

In summary, the records from four doctors who treated Trystan do not help 

the Sanchezes meet their burden of showing that the DTaP vaccination contributed 

to Trystan’s Leigh’s syndrome. Dr. Friedman presented her opinion before 

Trystan’s Leigh’s syndrome was diagnosed after genetic studies. Dr. Sharma and 

Dr. Haas obtained histories that are not entirely accurate. Even so, Dr. Sharma, Dr. 

Haas, and Dr. Wong appear to present temporal sequences. Accordingly, while 

these reports have been considered, they do not constitute persuasive evidence for 

the Sanchezes. 

VIII. Genetics

The previous sections (V, VI, and VII) constitute the Althen analysis and for 

the reasons explained therein, the Sanchezes have not met their burden of proof 

and, therefore, are not entitled to compensation. Nevertheless, the Secretary 

presented an alternative and independent explanation for finding that the 

Sanchezes are not entitled to compensation—Trystan’s genetic mutations. 

Like many sections in this remand decision, this section begins with a 

summary of the procedural posture (section A) because those steps are the basis for 

determining the scope of remand (section B). Then, section C sets forth the 

burdens with respect to alternative factors. Information about Trystan’s genetics, 

the parties’ arguments, and a summary of the most important articles are developed 
81

in sections D, E, and F, respectively. Finally, section G presents the reasons for 

finding that the mutations constitute the sole substantial cause of Trystan’s Leigh’s 

syndrome. 

A. Procedural History regarding Genetics

As noted earlier, Trystan was tested for genetic mutations during this 

litigation and the testing showed that he possessed two mutations. The testing 

company, GeneDX, described both mutations as pathogenic. Exhibit 53. 

The discovery of the genetic mutations added another aspect to the 

Sanchezes’ claim that the vaccination harmed Trystan. The Sanchezes brought in 

Dr. Niyazov because he has expertise in mitochondrial disorders. Dr. Niyazov

opined that the genetic mutation only predisposed Trystan to developing Leigh’s 

syndrome and the vaccination caused this disposition to become a reality. Exhibit 

68. Dr. Steinman, too, expressed a similar opinion, although the Sanchezes rely 

less upon Dr. Steinman. Exhibit 95. The Secretary’s expert, Dr. Raymond, who, 

like Dr. Niyazov, is board-certified in genetics opined that “Trystan Sanchez is a 

child with Leigh syndrome secondary to mutations in the gene SDHA. This is the 

sole cause of his neurologic condition.” Exhibit H at 8. The parties continued to 

develop their points through additional expert reports, briefing in advance of the 

hearing, and oral testimony during the December 2017 hearing. 

The October 9, 2018 decision found that the Sanchezes did not meet their 

burden of proof regarding Althen prongs 2 and 3. Thus, they were not entitled to 

compensation. However, because the parties had invested so much into the 

genetics issue, the undersigned offered additional views regarding the genetics 

aspect of the case. The undersigned concluded that “Trystan’s actual course is 

entirely consistent with what is known about his genetic mutations.” Decision at 

41, 2018 WL 5856556, at *25.

Following the decision, the Sanchezes filed a motion for review. The 

Sanchezes, however, did not present any argument regarding Trystan’s genetics. 

Rather, on the thirty-ninth and final page of their motion, the Sanchezes asserted 

that “[t]he perceived errors in this part of the Decision are not addressed in this 

Motion. Petitioner[s] reserve[] the right to [do] so in the event the issue comes to 

the forefront.” Pet’rs’ Mot. for Rev. at 39 n.34. The Secretary did not present any 

argument regarding genetics. See Resp’t’s Resp. to Mot. for Rev. The Reply, too, 

was silent on this issue. See Pet’rs’ Reply in Support of Mot. for Rev. The 

Court’s Opinion and Order denied the motion for review without commenting on 

the genetics. See Opinion and Order.
82

The parties’ briefs to the Federal Circuit were similar. Although the 

Sanchezes’ initial brief did not discuss the comments in the October 9, 2018 

decision regarding genetics, in their reply brief, the Sanchezes presented 

essentially the same footnote as they used in their motion for review. Again, the 

Sanchezes maintained that they “reserve[] the right to [address perceived errors in 

the Decision regarding genetics] in the event the issue comes to the forefront.” 

Reply of Appellants-Petitioners at 29 n.12. 

During oral argument, a member of the Federal Circuit panel inquired 

whether the Secretary was defending the October 9, 2018 decision on the basis of 

the genetics. The Secretary stated that he was not.45 

The Federal Circuit vacated the judgment based upon the October 9, 2018 

decision because of errors in the Althen analysis. In remanding for correction of 

these errors, the Federal Circuit permitted additional findings on the genetics issue: 

Finally, it may be necessary for the special master to address a 

question that was left open in the last two pages of the special 

master’s decision denying compensation: whether the 

Secretary showed, because of Trystan’s mutations, the timing 

and severity of his Leigh’s syndrome would have been the 

same, regardless of the effect of the vaccinations.

Sanchez, 809 F. App’x at 854. The Federal Circuit also stated that the special 

master could “give the parties an opportunity to supplement the record with any 

relevant medical research or reports postdating the hearing held by the special 

master two and one-half years ago.” Id.

On remand, the undersigned allowed the parties to present additional reports, 

see order, issued June 12, 2020, and the parties did so, addressing genetics along 

with other issues. E.g., exhibits 189, 195 (both Dr. Niyazov), P, Q (both Dr. 

Raymond). The parties’ experts also discussed genetics during the July 9, 2020 

45 Oral Argument at 17:07-17:43, Sanchez v. Sec’y of Health & Human Servs., 809 F. 

App’x 843 (2020) (No. 2019-1753), http://www.cafc.uscourts.gov/oral-argumentrecordings?title=Sanchez&field_case_number_value=2019-

1753&field date value2%5Bvalue%5D%5Bdate%5D=2020-02-07; see also Pet’rs’ Remand Br. 

at 67, 89. 
83

hearing. After the hearing, the parties made arguments regarding genetics in their 

briefs. 

B. Scope of Remand

Notwithstanding the Federal Circuit’s invitation to consider the genetics 

issue, the Sanchezes argue that the undersigned cannot evaluate this evidence on 

remand. They maintain, “The genetics portion of the Special Master’s decision 

made it clear that it was not how the [special master] decided the case. Therefore, it 

was not part of any appeal. The law of the case doctrine applies. Respondent did 

not rely on this portion of the Decision at either the Motion for Review or the 

Federal Circuit Appeal.” Pet’rs’ Remand Br. at 89; accord Pet’rs’ Reply on 

Remand at 20. 

However, the Sanchezes appear to misapprehend the law of the case 

doctrine. A trial court’s failure to rule on one claim or defense does not create a 

waiver for the party advancing the claim or defense. See Exxon Chem. Patents, 

Inc. v. The Lubrizol Corp., 137 F.3d 1475 (Fed. Cir. 1998) (an appellate 

conclusion that a party did not literally infringe a patent does not prevent the 

plaintiff from seeking a new trial under the doctrine of equivalents); Laitram Corp. 

v. NEC Corp., 62 F.3d 1388, 1395 (Fed. Cir. 1995) (reinstating a jury’s verdict 

decided on literal infringement and the doctrine of equivalents grounds, based only 

on the appellate determination of error with respect to the literal infringement 

claim and without reaching the doctrine of equivalents issue). 

C. Burdens regarding Alternative Factor

When petitioners carry their burden to show that a vaccine was the cause-infact of an injury, the Secretary may rebut this showing by establishing that the 

injury is “due to factors unrelated to the administration of the vaccine.” 42 U.S.C. 

§ 300aa–13(a)(1)(B).46 For the government to carry its burden, “the Secretary 

refutes the prima facie finding that the vaccination is both the ‘but for’ cause and a 

‘substantial factor’ in bringing about an alleged injury. . . . Because the factor 

unrelated must be the ‘sole substantial factor,’ the Secretary must establish that the 

factor unrelated, not the vaccination, actually caused the injury alleged.” 

Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363, 1369 (Fed. Cir. 

46 Because the Sanchezes have not met their burden to show that the DTaP vaccine 

contributed to Trystan’s injury, the burden of proof actually never shifted to the Secretary. 

However, the following analysis assumes that the Sanchezes met their burden of proof. 
84

2013). The Secretary’s burden with respect to alternative causation is “the same 

as” the standards for “petitioner’s proof of actual causation in fact in off-table 

cases.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 

1994). And, the petitioner’s burden is preponderance of the evidence. Bunting v. 

Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). 

The Sanchezes argue that the Secretary’s burden to establish an alternative 

factor as the cause of an injury is greater than a petitioner’s burden to establish 

causation-in-fact. For this proposition, the Sanchezes rely upon de Bazan v. Sec’y 

of Health & Human Servs., 539 F.3d 1347, 1351-54 (Fed. Cir. 2008). Pet’rs’ 

Remand Br. at 10-11, 74-75; Pet’rs’ Reply on Remand at 16-17. 

In that case, Adela Quintana de Bazan received a tetanus-diphtheria vaccine 

and within eleven hours developed symptoms of a neurologic disease, acute 

disseminated encephalomyelitis (ADEM). 539 F.3d at 1349-50. After a hearing, 

the special master credited the Secretary’s expert who had opined that eleven hours 

was too short to infer causation. On a motion for review, a judge of the Court of 

Federal Claims “held that the special master had erred by improperly failing to 

shift the burden to the government. The court held that the finding that the elevenhour onset of ADEM was not within a medically appropriate timeframe to attribute 

to the vaccine was tantamount to finding that de Bazan had failed to prove that no 

other cause could have caused her injuries.” Id. at 1350. After remand in which 

the Secretary presented no new evidence, the special master found in favor of the 

petitioner. The Secretary then appealed the judgment to the Federal Circuit. 

The Federal Circuit reversed. The Federal Circuit stated, “the court 

misunderstood our precedents.” Id. at 1353. The Federal Circuit held that in 

requiring Ms. de Bazan to show her ADEM arose in an appropriate amount of time 

after the vaccination, the special master did not impose an additional burden on 

her. In this context, the Federal Circuit stated that after a petitioner meets her 

burden under Althen, “The government then must provide that [contrary] proof by 

identifying a particular such factor (or factors) and presenting sufficient evidence 

to establish that it was the sole substantial factor in bringing about the injury.” Id.

at 1354. However, the Federal Circuit was not called upon to address dimensions 

of the “sole substantial factor” as the Secretary had not presented any evidence 

regarding a factor unrelated to the vaccine. Id. 

The Federal Circuit has ruled that a special master’s finding that a genetic 

mutation was the “sole substantial factor” to cause a child’s disease satisfies the 

respondent’s burden in showing that the injury was due to factors unrelated to the 
85

vaccine. See Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363 (Fed. 

Cir. 2013); Stone / Hammitt v. Sec’y of Health & Human Servs., 676 F.3d 1373

(Fed. Cir. 2012) (separate cases considered together on appeal); see also Snyder v. 

Sec’y of Health & Human Servs., 553 F. App’x 994 (Fed. Cir. 2014). While the 

children in all three cases47 had a mutation in the SCN1A gene, the most analogous 

case is Stone / Hammitt. 

When Rachel Hammitt was approximately four months old, she received a 

dose of the DTaP vaccine and several other vaccines. That evening, she 

experienced a febrile seizure for which she remained hospitalized for several days. 

About one month later, Rachel had a second seizure and was again treated in the 

hospital. Because of repeated seizures, she was diagnosed with epilepsy by her 

first birthday. Testing later showed she has a mutation in the SCN1A gene. Stone, 

676 F.3d at 1375. 

The petitioner in both Stone and Hammitt relied upon an opinion from 

Marcel Kinsbourne.48 “A key component of Dr. Kinsbourne's theory is that the 

initial seizure caused some form of lasting brain injury that had downstream 

consequences for both children, specifically a lowered seizure threshold. 

Accordingly, the special master sought evidence of brain damage resulting from 

the initial febrile seizures.” Id. at 1384. The petitioners failed to establish their 

cases because “Dr. Kinsbourne was unable to identify any evidence that either 

child had suffered brain damage as a result of those seizures.” Id. Thus, on 

remand, the special master found the petitioner in Hammitt “had not made a prima 

facie case.” Id. at 1378. On appeal the Federal Circuit ruled that the special 

master’s determination was not arbitrary because the petitioners “failed to show 

that the vaccines caused any brain damage.” Id. at 1384. 

The special master also found primarily based upon the testimony of Dr. 

Raymond, that “respondent proved by a preponderance of the evidence that [the] 

SCN1A gene mutation was the sole cause and was principally responsible for [the 

child’s disease].” Id. at 1378-79 (second alteration added, and citation omitted). 

At the Federal Circuit, the appellants-petitioners challenged a reliance on Dr. 

47 Actually, five children because the Federal Circuit consolidated two cases in Stone and 

Snyder. 

48 The special master expressed concerns about Dr. Kinsbourne’s reliability because he 

has not practiced pediatric neurology since 1981. This weakness in Dr. Kinsbourne’s 

background is not a problem for Doctors Steinman and Niyazov. 
86

Raymond’s opinion. However, the Federal Circuit found that the special master 

was not arbitrary in relying upon Dr. Raymond because, in part, Dr. Raymond 

considered multiple factors for finding that the SCN1A mutation was the sole 

cause of the children’s seizure disorder. Those factors were: 

(1) the gene mutation was not inherited but arose de novo, so 

the absence of SMEI in either parent was not probative; (2) the 

mutation resulted in a non-conservative amino acid change, i.e., 

the mutation produced a new amino acid having very different 

physical properties from the corresponding amino acid found in 

normal individuals; (3) the mutation affects a functionally 

important region, a portion of the sodium channel in neurons 

that is crucial to the normal functioning of the nervous system; 

(4) the mutation occurs in an area that is well conserved across 

species, “indicating that changes here are probably not well 

tolerated”; (5) there is an absence of the mutation in the normal 

population; (6) medical reports show that a mutation in the 

same location has been associated with SMEI; and (7) between 

80 and 90 percent of patients with SMEI have an SCN1A gene 

mutation. 

Id. at 1383. The Federal Circuit stated that based upon this evidentiary support, 

“we cannot conclude that the special master’s conclusion that the SCN1A gene 

mutation was solely responsible for [Amelia Stone’s] SMEI was arbitrary or 

capricious.” Id. at 1384. 

Here, the Sanchezes give little recognition to the SCN1A cases, saying, 

without elaboration, that their case is “unlike” the SCN1A cases. Pet’rs’ Remand 

Br. at 76. Rather, the Sanchezes emphasize a precedential opinion that the Federal 

Circuit issued while their case was on remand, Sharpe v. Sec’y of Health & Human 

Servs., 964 F.3d 1072 (Fed. Cir. 2020).49 

Heidi Sharpe, the mother of L.M., noticed her daughter having episodes of 

“spacing out” during which L.M. was not responsive for several seconds when she 

49 While the Secretary was invited to comment upon Sharpe, the Secretary stated, “the 

Federal Circuit has not yet issued its mandate in Sharpe; accordingly, it is premature for the 

parties to be speculating about the potential effect of the Sharpe panel’s decision.” Resp’t’s 

Remand Br. at 25. 
87

was approximately five months old. Id. at 1076. At six months old, L.M. received 

a series of vaccination, including the DTaP vaccine. Later that evening, L.M. was 

lethargic, had poor muscle tone, and did not eat. L.M.’s mother called the 

hospital’s emergency room twice and her pediatrician later that morning. 

According to L.M.’s mother, for the next three days, L.M. remained lethargic, had 

poor head control, and did not interact with her environment. Id. Five days after 

vaccination, L.M. had a seizure for which she was brought to the hospital. Doctors 

stated that she had “fairly poor head control.” Id. She was diagnosed with 

infantile spasms. At some point, a genetic mutation was discovered. 

L.M.’s mother alleged that L.M. had a pre-existing seizure disorder and the 

vaccines significantly aggravated it.50 Under this cause of action, Ms. Sharpe is 

required to establish the six elements first enumerated in Loving v. Sec’y of Health 

& Human Servs., 86 Fed. Cl. 135, 144 (2009). Sharpe, 964 F.3d at 1080. The 

special master found that Ms. Sharpe had failed to establish elements 3 (a 

significant aggravation of the prior condition), 4 (a medical theory), and 5 (a 

logical sequence of cause and effect). The special master also found that L.M.’s 

“gene mutation, and not the vaccination, was the sole, substantial cause of L.M.’s 

significantly aggravated seizure disorder.” Id. 

The Federal Circuit ruled that the special master erred on all four points. For 

the Sanchezes’ case, the most important comments from the Federal Circuit 

include a holding that petitioners do not bear the burden of establishing that the 

vaccinee’s current condition is worse than the normal and expected course of the 

underlying disorder. The Federal Circuit also quoted testimony from the 

Secretary’s witness that “[t]he dream of the geneticist is to find genotypephenotype correlation.” Id. at 1082 (citation omitted). The Federal Circuit also 

found that the special master’s finding that the genetic mutation was the likely sole 

substantial factor causing L.M.’s severe seizure disorder was not supported by 

substantial evidence. The record did not support the special master’s conclusion 

because the specific mutation in L.M. “generally result[s] in non-severe, noncognitive disorders.” Id. at 1086. For these reasons (and more), the Federal 

Circuit vacated the judgment based upon the special master’s decision. 

50 Ms. Sharpe also alleged that L.M. experienced a significant aggravation of her seizure 

disorder due to the DTaP vaccine and claimed compensation as an on-Table injury. The special 

master denied compensation on that theory and the Federal Circuit affirmed for reasons not 

relevant to the Sanchezes’ case. 
88

D. Trystan’s Genetic Mutations

During initial entitlement proceedings, the Sanchezes introduced evidence of 

Trystan’s specific genetic mutations. The October 9, 2018 decision articulated 

these genetic mutations as follows:

Trystan inherited two heterozygous mutations in his SDHA 

gene. Because of the nature of the mutations and their effect on 

the SDHA protein, the mutations are considered pathogenic. 

The parties dispute whether these two mutations made 

Trystan’s disease a fait accompli. 

To understand the potential effect of Trystan’s inherited 

mutations on Trystan’s clinical course, it is important to review 

Trystan’s specific mutations and what is known about them.

Trystan’s two mutations in his DNA are referred to as 

c.1571C>T and c.667delG. Exhibit 59 at 1. The first indicates 

that at location 1571 in the gene, a cytosine (C) has been 

replaced by a thymine (T). The second indicates that a guanine 

(G) that is supposed to be present at position 667 has been 

deleted. In the case of the first, this mutation changes the 

nucleic acid code so that where there is supposed to be an 

alanine in the protein, the cell now puts a valine (p.Ala524Val). 

In the case of the second, the mutation changes the nucleic acid 

sequence in a manner that creates a premature stop signal in the 

place of a signal for an amino acid. In other words, the cell 

believes that no more of the nucleic acid chain needs to be 

translated into amino acid, resulting in a shortened, or 

truncated, protein (p. Asp223IlefsX3). 

Decision at 31, 2018 WL 5856556, at *19.

E. Overview of Parties’ Positions regarding Genetics

The Secretary maintains that “[t]he onset and progression of Trystan’s 

unfortunate condition is entirely explained by what is currently known about 

Leigh’s syndrome generally and Trystan’s gene mutations specifically.” Resp’t’s 

Remand Br. at 26. The Secretary’s position comes from the opinion of Dr. 

Raymond, who relies primarily on the Parfait article, which is discussed below. 
89

Primarily through the opinion of Dr. Niyazov, the Sanchezes maintain that 

Trystan’s genetic mutations were not sufficient, by themselves, to cause him to 

suffer Leigh’s syndrome. Trystan’s genetic mutations would cause Leigh’s 

syndrome only after a stressful event, which was his vaccination. See Pet’rs’ 

Remand Br. at 68.51 Dr. Niyazov relies primarily upon the Levitas article. 

F. Important Articles regarding Mutations

In the October 9, 2018 decision, the undersigned outlined and summarized 

relevant articles presented by the parties as follows:

Exhibit H, tab 7 (Thomas Bourgeron et al., Mutation of a 

Nuclear Succinate Dehydrogenase Gene Results in a 

Mitochondrial Respiratory Chain Deficiency, 11 Nature 144-49 

(1995)) presents the first account of a mutation in SDHA being 

associated with a mitochondrial disease in humans. In this 

study, the authors reported that two sisters both had a 

homozygous mutation in SDHA (c.1684 C>T) and that both 

sisters developed Leigh’s syndrome at 10 months of age. One 

died at 19 months and another was still alive at 13 months. 

Exhibit 110 (Beatrice Parfait et al., Compound Heterozygous 

Mutations in the Flavoprotein Gene of the Respiratory Chain 

Complex II in a Patient with Leigh Syndrome, 106 Human 

Genetics 246-43 (2000)) presents a case study of a child with 

Leigh’s syndrome who, like Trystan, had a compound 

heterozygous mutation of her SDHA gene. The child in Parfait 

shared one of his two mutations with Trystan (c.1571 C>T). 

However, the other mutation was distinct between the two 

children. Little is known about the course of the disease for the 

young child presented in the Parfait article, other than that she 

presented with Leigh’s syndrome at 9 months of age, 

demonstrating psychomotor delays and cerebellar ataxia. The 

authors in the Parfait article took the additional step of showing 

51 The Sanchezes state that the approximately three weeks between the conclusion of the 

hearing and the deadline for the submission of their initial brief constituted an “[i]nsufficient 

time . . . to outline in full all of the reports and testimony by Dr. Niyazov regarding the gene 

mutations[,] the variable expressivity[,] and partial expressivity.” Pet’rs’ Remand Br. at 70. 

However, their argument spans many pages. See id. at 66-82, 89-90. 
90

that the reduced functioning of the young child’s SDH protein 

was attributable to the c.1571C>T mutation (the mutation 

Trystan had), confirming the mutation’s pathogenicity. 

Exhibit 94 (Rudy Van Coster et al., Homozygous Gly555Glu 

Mutation in the Nuclear-Encoded 70 kDa Flavoprotein Gene 

Causes Instability of the Respiratory Chain Complex II, 120A 

Am. J. Medical Genetics 13-18 (2003)) presents the case study 

of a young child with a homozygous mutation in the SDHA 

gene (c.1664 G>A) whose symptoms developed at five months 

of age and then died two weeks later following a respiratory 

infection. Though the child may have had Leigh’s syndrome, 

she “died in infancy before any sign of Leigh syndrome could 

develop.” Id. at 4.

Exhibit H, tab 28 (R. Horvath et al., Leigh Syndrome Cased by 

Mutations in the Flavoprotein (Fp) Subunit of Succinate 

Dehydrogenase (SDHA), 77 J. Neurology Neurosurgery 

Psychiatry 74-76 (2006) presents the case of a young girl with a 

compound heterozygous mutation in her SDHA gene. Her two 

mutations were not seen in any other study. The patient first 

showed signs of Leigh's syndrome at five-months of age. While 

she had reached 10 years at the time the study was published, 

she had also shown an arrest of her psychomotor development 

and experienced recurrent seizures. 

Exhibit H, tab 27 (Alistair T. Pagnamenta et al., Phenotypic 

Variability of Mitochondrial Disease Caused by a Nuclear 

Mutation in Complex II, 89 Molecular Genetics and 

Metabolism 214-21 (2006)) presents the case of a young boy 

with the exact same mutations presented in exhibit 94 (Van 

Coster). However, in contrast to the patient described in Van 

Coster, the patient in Pagnamenta did not develop symptoms of 

Leigh’s syndrome until 22 months of age. While his onset was 

rapid, he began showing an improved clinical picture after 

turning four. At the time the article was published, the child 

was 10 years old and showed variably impaired motor function, 

but did not appear to manifest any cognitive deficits and 

attended a mainstream school. 
91

Exhibit 79 (Aviva Levitas et al., Familial Neonatal Isolated 

Cardiomyopathy Caused by a Mutation in the Flavoprotein 

Subunit of Succinate Dehydrogenase, 18 European J. Human 

Genetics 1160-65 (2010)) is the most recently published article 

in the record concerning the significance of SDHA mutations. 

The Levitas article is unique for two reasons. First, the authors 

presented an examination of fifteen individuals from two large 

consanguineous families, allowing for better discrimination 

about the penetrance of the mutation. Second, the patients did 

not present with Leigh’s syndrome. Instead, with the exception 

of one patient, the subjects had, or had died of, 

cardiomyopathies of various severities. The onset of the 

disease, or death, occurred at earlier than one year of age in all 

the children studied. This is all the more fascinating because 

the mutation involved in Levitas was the same exact mutation 

that was associated with Leigh’s syndrome in Van Coster and 

Pagnamenta. Nonetheless, not a single family member 

developed Leigh’s syndrome. Even more, at least one patient, 

the father, who had the homozygous mutation that was also 

present in Van Coster and Pagnamenta (c.1664 G>A), had no 

symptoms of disease at all. This astonished the researchers and 

they performed several follow-up studies to try to explain this 

finding, though they had no success. Importantly, it was 

confirmed that this patient had a loss of function of the SDH 

gene, much as was the case in Parfait, but nonetheless did not 

develop any disease.

Decision at 31-33, 2018 WL 5856556, at *19-20.

In December 2017, when Dr. Niyazov and Dr. Raymond testified, Trystan’s 

second mutation (the c.667delG mutation) had not been reported in the literature. 

Tr. 2089. With the passage of time, doctors have reported this mutation in the 

context of epilepsy and paraganglioma tumors. Exhibit 189 (Dr. Niyazov’s June 

19, 2020 report) at 2; see also exhibit P (Dr. Raymond’s June 19, 2020 report) at 

5.52

52 Dr. Raymond did not note the appearance of the c667delG mutation in epilepsy and 

paraganglioma tumors. See exhibit P. Given that this oversight was brought up during his 
92

G. Evaluation of the Genetic Evidence

After discussing pathogenicity and penetrance, the October 9, 2018 decision 

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

his genetic mutations.” Decision at 41, 2018 WL 5856556, at *25. However, the 

undersigned did not make an explicit finding as to whether the genetic mutations 

were the sole substantial cause of Trystan’s Leigh’s syndrome. 

The undersigned now finds that Trystan’s mutations were the sole 

substantial cause of his Leigh’s syndrome. While the reasons for this finding are 

presented below, the undersigned first explains why this finding is being made 

now, as opposed to October 2018. 

The October 9, 2018 decision did not require a finding with respect to the 

genetics issue. It was sufficient to find that the Sanchezes did not carry their 

burden regarding Althen prong 2 and Althen prong 3. When special masters can 

resolve a case a based upon one issue, they do not necessarily need to address all 

issues. See, e.g., Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355, 

1365 (Fed. Cir. 2012); Vaughan v. Sec’y of Health & Human Servs., 107 Fed. Cl. 

212, 222 (2012).

It is still correct that the genetics issue is an alternative basis for denying 

compensation to the Sanchezes in that, even after consideration of the arm 

contortions, they have not met their burdens regarding Althen prong 2 and Althen

prong 3. See sections VI and VII above. Nevertheless, under the circumstances of 

this case, a finding regarding genetics will advance judicial economy because as 

part of the remand process, the undersigned has re-reviewed the evidence 

regarding genetics. 

Dr. Niyazov has made some points regarding the incomplete penetrance of 

some SDHA genetic mutations. The results from the Levitas article cannot be—

and are not—dismissed out of hand. 

On the other hand, the Secretary’s burden to show that the genetic mutations 

are the sole substantial cause of Trystan’s Leigh’s syndrome is a simple 

preponderance of the evidence. The Secretary does not have to present either a 

testimony, Tr. 2089, 2092-96, 2134-35, 2169, the Secretary’s statement that “no clinical 

information [has been] provided” seems inaccurate. Resp’t’s Remand Br. at 28. 
93

clear and convincing case or a case beyond a reasonable doubt. The Secretary is 

only required to tip the metaphorical scales of justice. 

The Secretary has carried this burden in this case. Much as he was in Stone, 

Dr. Raymond was a credible expert. Dr. Raymond’s reliability comes, in part, 

from his reliance on the Parfait paper. As indicated in the title of the article, the 

child in Parfait suffered from compound heterozygous mutations in the 

flavoprotein gene of the respiratory chain complex II. “Heterozygous” means that 

one of the child’s parents provided one normal gene and one of the child’s parents 

provided one mutation.53 “Compound” means that the child suffered two different 

heterozygous mutations. 

Dr. Raymond’s reliance on Parfait stems from the similarity in genetic 

mutations between the Parfait child and Trystan. In both children, the genetic 

mutation at codon 524 is exactly the same. Tr. 478, 537 (Dr. Niyazov). The 

second mutation created a premature stop code in the gene, resulting in a shorter 

protein. Although the details of the second genetic mutation in the Parfait child 

and Trystan do not match entirely, the end result--a shortened protein—is the 

same. Tr. 814-15, 980. 

After the Parfait researchers discovered the mutations, they explored the 

significance. With respect to the c.1571C>T mutation, the mutation that Trystan 

shares, the researchers determined that it was “absent from 150 controls.” Beatrice 

Parfait et al., Compound heterozygous mutations in the flavoprotein gene of the 

respiratory chain complex II in a patient with Leigh syndrome, 106 Hum. Genetics 

236, 236 (2000), filed as exhibit 110. The researchers used fibroblasts to see how 

the gene performed in tissue cultures. Id. at 241; Tr. 539. Their experiment 

“confirm[ed] the deleterious effect of this mutation.” Exhibit 110 (Parfait) at 241. 

The Parfait researchers did not perform a functional analysis on the second 

mutation, which may result in a shortened protein. Tr. 995. However, as Dr. 

Niyazov recognized, shortened proteins often contribute to disease because the 

entire protein is not created. Tr. 912-13; see also Tr. 806-07 (Dr. Raymond 

discussing GeneDx report that truncation mutations are almost always pathogenic). 

While Dr. Raymond opined that the Parfait article supported a finding that 

Trystan’s genetic mutations, and solely his genetic mutations, caused Trystan’s 

53 Although Dr. Niyazov maintained that one of the Parfait child’s mutations was 

homozygous, Tr. 489, 978, this interpretation seems to be erroneous. Tr. 1001-02. 
94

Leigh’s syndrome, Dr. Niyazov’s response to Parfait varied. On the one hand, Dr. 

Niyazov agreed that Trystan could be compared to the child in Parfait because one 

of the two mutations (the 524 mutation) was the same. Tr. 488. Dr. Niyazov

agreed that the 524 mutation was “deleterious” and an “altering function 

mutation.” Tr. 541, 543. Despite this agreement, Dr. Niyazov would not concede 

that the mutation caused disease because Dr. Niyazov would “need to see the 

clinical features of the patient.” Tr. 542. He defended his position by citing 

Levitas. 

In the respect of needing to see clinical features of the patient, Dr. Niyazov

seems to be demanding a level of scientific certainty that exceeds the 

preponderance of the evidence standard. Contrary to a question posed by the 

Sanchezes’ attorney during cross-examination of Dr. Raymond, the Parfait article 

does not represent a case report in which the researchers memorialized an event 

and an outcome. See Tr. 896-97. While the Federal Circuit in Sharpe warned 

against relying upon a single case study, Sharpe, 964 F.3d at 1084 (discussing the 

Ambry patient), the Parfait article is not a simple case report. Instead, the Parfait 

researchers studied how the gene would be expressed in cell cultures. Exhibit 110 

(Parfait) at 241. This experiment strengthens the value of the Parfait article, 

making it worthy of more weight than case reports, which petitioners in the 

Vaccine Program often supply. See, e.g., Campbell v. Sec’y of Health & Human 

Servs., 97 Fed. Cl. 650, 668-69 (2011); Tompkins v. Sec’y of Health & Human 

Servs., No. 10-261V, 2013 WL 3498652, at *23-24 (Fed. Cl. Spec. Mstr. June 21, 

2013), mot. for rev. denied, 117 Fed. Cl. 713 (2014). While Dr. Niyazov may be 

correct from a scientist’s perspective that an in vivo, as opposed to in vitro, 

experiment may be more informative, Dr. Niyazov has not proposed how an in 

vivo study could be conducted on the 524 mutation. Furthermore, the Vaccine 

Program does not demand this level of proof from petitioners when they attempt to 

establish that a vaccine harmed them. Consequently, the Secretary cannot be held 

to a standard of proof that requires scientific certainty. Knudsen v. Sec’y of Health 

& Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994).

The gene expression studies are conducted, as far as the undersigned is 

aware, to minimize the contribution, if any, from environmental factors, such as 

vaccinations. And based upon the gene expression studies in Parfait, Dr. Niyazov

appropriately conceded that the researchers had determined that the 524 mutation, 

which is the mutation Trystan shares with the Parfait child, is an “altered function”

mutation. Tr. 543. From this concession that the 524 mutation alters the function 

of its associated protein, it seems reasonable to conclude that the altered function 

will lead to a disease, especially when that conclusion is supported by Dr. 
95

Raymond’s opinion. From the conclusion that the 524 mutation is likely to cause a 

disease, it also seems logical to conclude that the specific disease a compound 

heterozygous mutation involving the 524 gene is likely to cause is Leigh’s 

syndrome because the Parfait child developed Leigh’s syndrome. 

Additional support for the finding that the 524 mutation in combination with 

the other mutation caused Trystan’s Leigh’s syndrome can be found by examining 

the factors upon which Dr. Raymond relied in Stone.

54

Factor in Stone Trystan’s case

(1) the gene mutation was not inherited 

but arose de novo, so the absence of 

SMEI in either parent was not 

probative;

Trystan inherited one mutation from 

each parent. Neither parent had both 

mutations. 

(2) the mutation resulted in a nonconservative amino acid change, i.e., 

the mutation produced a new amino 

acid having very different physical 

properties from the corresponding 

amino acid found in normal 

individuals;

Present in Trystan’s case. The second 

mutation produced a shortened protein. 

(3) the mutation affects a functionally 

important region, a portion of the 

sodium channel in neurons that is 

crucial to the normal functioning of the 

nervous system;

The gene expression studies on the 524 

mutation in Parfait suggest that the 

relevant region is crucial. 

(4) the mutation occurs in an area that 

is well conserved across species, 

“indicating that changes here are 

probably not well tolerated”;

The SDHA gene is highly conserved 

across species. Tr. 527 (Dr. Niyazov). 

54 By returning to the list of factors in Stone, the undersigned is not suggesting that the 

list amounts to some sort of legal test. However, given that the Federal Circuit in Stone found 

Dr. Raymond’s ultimate conclusion not arbitrary, the methodology or factors that he considered 

appear relevant. 
96

(5) there is an absence of the mutation 

in the normal population;

This appears to be true for Trystan. 

The Parfait researchers did not find the 

524 mutation in 150 controls. See Tr. 

909 (Dr. Raymond’s testimony about 

lack of appearance in the normal 

population), 2169-70 (Dr. Niyazov

discussing, in the context of the Parfait 

article, an absence of cases with 

Trystan’s specific genetic mutations). 

(6) medical reports show that a 

mutation in the same location has been 

associated with SMEI;

Parfait constitutes a single report (not 

plural reports) that a compound 

heterozygous mutation has been 

reported in Leigh’s syndrome. But the 

c.667delG has not been reported in 

Leigh’s syndrome. 

(7) between 80 and 90 percent of 

patients with SMEI have an SCN1A 

gene mutation.

Not present. 

Thus, most of these seven factors tend to align with a finding that Trystan’s 

compound heterozygous mutation caused his Leigh’s syndrome. 

While a strength to Dr. Raymond’s opinion is that he based his analysis on 

the genetic mutations that Trystan has, Dr. Niyazov’s opinion is relatively weaker 

because he relies upon Levitas, which reported results on a different genetic 

mutation. Dr. Niyazov’s reliance on Levitas is not irrational for Levitas does 

illustrate the point that SDHA genes can have variable expressivity. However, 

Levitas merits less weight than the Parfait article that included a gene expression 

study on the gene that affects Trystan. In other words, Levitas and Dr. Niyazov’s 

opinion about Levitas and the other articles he has cited might prevent a finding 

that the Secretary had clearly and convincingly established the genetic mutations as 

the sole substantial cause. But, the value of Levitas and Dr. Niyazov’s opinion is 

not so strong to defeat a claim based upon a preponderance of the evidence. 

In addition, despite receiving inaccurate histories concerning Trystan’s 

health in the months following the vaccination, two doctors have linked Trystan’s 

genetic mutation to his Leigh’s syndrome. As noted above, Dr. Wong, a medical 
97

geneticist, stated “Trystan is a 7 year old male with mitochondrial complex II 

deficiency secondary to compound heterozygous mutations in the succinate 

dehydrogenase A (SDHA) gene.” Exhibit 139 at 5. Dr. Haas also told other 

doctors that “Trystan Evan Sanchez has a mitochondrial disease caused by 

Complex II deficiency of the respiratory chain. This is a genetic disease . . . .” 

Exhibit 62 at 6. These statements reinforce the finding that the pair of genetic 

mutations is the sole substantial cause for Trystan’s Leigh’s syndrome. 

IX. Summary

After the Federal Circuit’s mandate, the undersigned identified four issues 

within the scope of the Federal Circuit’s remand. Order, issued June 12, 2020. 

While the reasoning is explained above, the resolution is set forth below concisely.

Issue A: Trystan’s neurologic state in February 2009. 

In February 2009, Trystan was neurologically normal. 

Issue B: Trystan’s health from end of February 2009 to end of May 

2009. 

During this time, Trystan suffered from colds periodically. He did not 

develop any neurologic problems until he began to lose skills no sooner than May 

1, 2009. After May 1, 2009, he continued to lose skills. 

Issue C: Trystan’s health in August to October 2009. 

From May to August and August to October 2009, Trystan declined 

neurologically. However, this decline does not constitute a rechallenge. 

Issue D: Leigh’s syndrome. 

Trystan’s compound heterozygous mutations are the sole substantial cause 

of his Leigh’s syndrome. 

X. Conclusion

The Sanchezes have demonstrated their love and concern for Trystan by, 

among other things, their persistence in this litigation. Through the Sanchezes’

dedication, the Federal Circuit identified an error in the October 9, 2018 decision 

and remanded the case. 
98

On remand, the corrected record does not show that the February 5, 2009 

DTaP vaccination harmed Trystan. Although Trystan contorted his arm on 

February 16, 2009, this isolated event was not a manifestation of a neurologic 

problem. For the relevant time after the February 5, 2009 vaccine, Trystan was 

developing normally. 

Furthermore, Trystan’s genetic mutations are likely to be the sole substantial 

cause for his Leigh’s syndrome. The genetic explanation constitutes an alternative 

reason to find that the vaccination did not harm Trystan. 

Pursuant to Vaccine Rule 28.1(a), the Clerk’s Office is instructed to deliver 

this decision to the judge assigned to this case. In the absence of a motion for 

review, the Clerk’s Office is instructed to enter judgment in accord with this 

decision. 

IT IS SO ORDERED.

s/ Christian J. Moran

Christian J. Moran

Special Master