Y. v. Secretary of Health and Human Services

In the United States Court of Federal Claims

No. 17-850V

(Filed: February 1, 2021)

(Reissued: March 2, 2021)1

)

A.Y., by his parents and natural )

guardians, )

J.Y. and S.Y. )

)

Petitioners, )

)

v. )

)

SECRETARY OF HEALTH & )

HUMAN SERVICES, )

)

Respondent. )

)

Renee J. Gentry, Vaccine Injury Litigation Clinic, George Washington University Law

School, Washington, D.C., for Petitioner.

Jeremy Fugate, United States Department of Justice, Civil Division, Washington, D.C., for

Respondent. On the brief were Ethan P. Davis, Acting Assistant Attorney General, Civil

Division, C. Salvatore D’Alessio, Acting Director, Catherine E. Reeves, Deputy Director,

and Jennifer L. Reynaud, Torts Branch, Civil Division, United States Department of

Justice, Washington, D.C.

OPINION AND ORDER

SOLOMSON, Judge.

On June 22, 2017, Petitioners, [* * *], filed a petition for compensation on behalf

of their minor son, A.Y, pursuant to the National Childhood Vaccine Injury Act of 1986

1On February 1, 2021, the Court issued under seal an unredacted version of this opinion and

order in accordance with Rule 18(b) of the Vaccine Rules (Appendix B) of the Court of Federal

Claims. The Court provided the parties with 14 days to propose redactions. On February 16,

2021, Petitioners filed proposed redactions, ECF No. 60–1, to which the government did not file

an objection. The Courts adopts Petitioners’ proposed redactions and accordingly reissues this

public version of this opinion and order.

(the “Vaccine Act”), 42 U.S.C. §§ 300aa-1 et seq. Petitioners alleged that A.Y.

experienced a skin rash in 2014 or 2015 because of a varicella vaccine that he received,

seven-years earlier, on November 15, 2007. Chief Special Master Corcoran denied the

petition, concluding that Petitioners failed to prove by a preponderance of the evidence

that: (1) A.Y. actually experienced a reactivation of varicella; (2) varicella could

reactivate seven years after vaccination; and (3) given A.Y.’s complicated medical

history, that the varicella vaccine caused the alleged post-reactivation symptoms. A.Y.

v. Sec’y of Health & Human Servs., 2020 WL 5351342, *1 (Fed. Cl. Spec. Mstr. June 26,

2020) (ECF No. 45). Petitioners seek review of Chief Special Master Corcoran’s decision,

arguing that he abused his discretion in reaching these factual conclusions, that he

utilized medical research from outside the pleadings, and improperly declined to credit

the opinion of Petitioners’ expert witness. Respondent, the United States, counters that

Chief Special Master Corcoran provided a reasonable explanation for his decision and

that, in accordance with the highly deferential standard of review applicable to this

case, this Court should not second-guess that reasoned decision.

For the reasons explained below, the Court denies Petitioners’ motion for review

and sustains the Chief Special Master’s denial of Petitioners’ claim for compensation.

I. Factual And Procedural Background2

A. A.Y.’s Medical History

On November 14, 2006, A.Y., the eldest of triplets, was born prematurely. A.Y.,

2020 WL 5351342 at *2. He spent the subsequent month in the hospital’s neonatal

intensive care unit. Id. During that time, he was treated for reflux. Id. In November

2007, when A.Y. was one-year old, he received the varicella vaccine. Id. He did not

experience any immediate symptoms as a result of vaccination. Id.

Shortly thereafter, [* * *] became concerned that A.Y. was experiencing

developmental delays. Id. Beginning in December 2007, A.Y. started receiving speech

and occupational therapy through early childhood intervention services; on June 25,

2008, A.Y. was further evaluated for developmental delays at the Helping Hands Clinic

in San Antonio, Texas. Id. During this time, the [* * *] also became concerned with

A.Y.’s gastrointestinal health. Id. A.Y.’s pediatrician noted that A.Y. was eating certain

solids, but had difficulty with yogurt, cheese, or meat. Id. In 2009, A.Y. was evaluated

2For the purpose of resolving the pending motion for review, the Court summarizes the facts as

presented in the Chief Special Master’s decision and does not make independent findings of

fact. See, infra, Section II; see also Pafford v. Sec’y of Health & Human Servs., 64 Fed. Cl. 19, 22 n.4

(2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006).

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by Dr. Ricki G. Robinson, a clinical pediatric professor, at Descanso Medical Center for

Development and Learning in LeCanada, California, who documented A.Y.’s eating

difficulties. Id. A.Y. tested negative for celiac disease and his antibody levels were

found to be within the normal range. Id.

In November 2009, after A.Y. turned three-years old, he was formally diagnosed

with autism. A.Y., 2020 WL 5351342 at *2. In light of this diagnosis and his persistent

gastrointestinal issues, the [* * *] took A.Y. to Dr. Jerrold Kartzinel at the Kartzinel

Wellness Center in Orlando, Florida for further observations. Id. In a July 2010 “to

whom it may concern” letter, Dr. Kartzinel asserted that “A.Y. had been diagnosed with

epilepsy, gastroesophageal reflux, encephalopathy, metabolism disorder, sleep

disorder, immune mechanism disorder, and abnormal feces.” Id. at *3. Dr. Kartzinel

also recommended a specific diet for A.Y. Id.

Over the ensuing four years (from 2010 until 2014), “A.Y. received a dizzying

number of treatments and medications.” Id. A.Y. was administered a “‘mito cocktail’ of

supplements to treat a purported mitochondrial/energy processing disorder” and was

prescribed numerous medications, including:

(a) three 90-day courses of Acyclovir/Valtrex (an antiviral

drug used primarily for treatment of herpes and chickenpox);

(b) antibiotics and antifungal medication for “mouthing”;

(c) leucovorin/folinic acid, most commonly used to treat

chemotherapy side effects or folate deficiencies;

(d) Gabapentin/Neurontin (nerve pain medication and

anticonversant);

(e) an attention-deficit/hyperactivity disorder medication;

and

(f) a medication used to treat dementia and Alzheimer's

disease.

Id. (internal citations omitted). Additionally, “A.Y. received hyperbaric oxygen therapy,

a questionably-effective therapy often employed in the treatment of autism[, a]nd in the

late fall of 2013, A.Y. received stem cell therapy as well.” Id. (internal citations omitted).

In September 2013, A.Y. was diagnosed with a “cycle of abdominal pain” that

“continued off and on, varying in [its] severity.” Id. To treat his abdominal issues, in

late 2014, A.Y. received immunoglobulin and steroidal treatments, in addition to stem

cell treatments. Id.

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In January 2015, A.Y., now eight-years old, “developed a rash, starting on his

neck and spreading throughout his body.” A.Y., 2020 WL 5351342 at *4. A.Y.’s

pediatrician diagnosed the rash as “possible atypical varicella” and prescribed Acyclovir

(the same anti-viral medication that A.Y. had received years earlier). Id. (emphasis

added). The rash “almost cleared up” within a few days; A.Y.’s pediatrician did not

conduct testing to confirm the varicella diagnosis. Id. On January 8, 2015, in an on-line

discussion with Dr. Kartzinel, the [* * *] reported that the rash “[n]ever caused itching

or discomfort.” Id.

In November 2015, the [* * *] consulted with Dr. Kartzinel again, at which time

they discussed A.Y.’s stomach pains and “the beginnings of a chick[en] pox type rash.”

Id. That same month, Dr. Arthur Krigsman, a gastroenterologist, examined A.Y. as part

of a pre-endoscopy and colonoscopy physical. Id. at *5. At this time, the [* * *]

claimed that A.Y. had experienced five episodes of “chickenpox lesions” over the past

eleventh months but had been successfully treated with Acyclovir. Id. Following A.Y.’s

endoscopy and colonoscopy, Dr. Krigsman diagnosed him with autism spectrum

disorder-associated enteritis. Id. Subsequently, Dr. Anne Gershon, a researcher and

professor at Columbia University College of Physicians and Surgeons, reviewed the

biopsy results from the endoscopy and colonoscopy. Id. Dr. Gershon informed

Dr. Krigsman that she “found RNA transcripts of 3 [varicella] genes . . . in the intestinal

specimens.” Id. (bracketed alteration in original). Dr. Gershon advised the [* * *] that

A.Y. should take Valacyclovir for his stomach pains and that he should see Dr. Raffi

Tachdjian, an allergist and immunologist. Id.

In December 2015, Dr. Tachdjian evaluated A.Y. Id. Dr. Tachdjian found that

A.Y.’s medical history was not entirely consistent with a reactivation of a varicella

infection. Id. Specifically, he noted that photos of A.Y.’s rash was “not that of classic

varicella” and that A.Y. previously had tested negative for antibodies. Id. To help with

A.Y.’s “poor antibody function,” Dr. Tachdjian prescribed IVIG therapy. Id. On

February 3, 2016, A.Y. was seen by Dr. Paul Krogstad, a pediatric disease specialist, who

opined that while the rashes were “compatible with varicella,” because they quickly

cleared up after being treated with Acyclovir, other possible causes, such as viral

exanthemas or enterovirus infections, should be considered. Id. at *6. In an August

2016 letter, Dr. Tachdjian reiterated his belief that the cause of A.Y.’s rash was still

undetermined but noted that a saliva test performed on A.Y. in February 2016 that

tested positive for varicella appeared to corroborate Dr. Gershon’s findings that A.Y.

suffered from a “recurrent Varicella infection.” Id. at *5.

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B. Procedural History

1. The [* * *] File A Petition For Compensation

On June 22, 2017, the [* * *] filed a petition for compensation pursuant to the

Vaccine Act. ECF No. 1. On November 7, 2017, Petitioners filed portions of A.Y.’s

relevant medical records but did not complete these records until August 2018.3 ECF

Nos. 7, 8, 26. The [* * *] alleged that A.Y. developed a varicella skin rash in 2014 or

2015 as a result of a varicella vaccine that he received on November 15, 2007. A.Y., 2020

WL 5351342 at *9. They also alleged that, because of the reactivation of varicella, A.Y.

suffered a significant aggravation of his preexisting abdominal and behavioral issues.

Id. On November 15, 2018, the government filed its report, recommending denying the

petition. ECF No. 29. Given the novelty of the [* * *]’ claim that varicella vaccine

could reactivate seven-years later, Chief Special Master Corcoran ordered additional

briefing on that issue and the parties filed timely responses. ECF Nos. 38, 41, 44.

2. Expert Testimony

On March 28, 2019, the [* * *], in support of their contentions, presented expert

opinion testimony from three doctors: Dr. Robinson, Dr. Richard A. Honaker, and

Dr. Gershon. ECF No. 34; see A.Y., 2020 WL 5351342 at *6. Dr. Robinson submitted a

three-page report that largely summarized A.Y.’s medical history based on her personal

knowledge of his autism-related developmental challenges. Id. While Dr. Robinson

assumed that A.Y.’s worsening behavioral changes were caused by the varicella

reactivation, she did not purport to have “direct knowledge pertaining to how a vaccine

might result in viral reactivation.” Id. (emphasis in original). Instead, Dr. Robinson’s

opinion relied entirely upon Dr. Gershon’s opinion that the November 2015 biopsy

revealed the same varicella strain as contained in the vaccine that A.Y. received seven-

years earlier. Id.

Dr. Honaker, who had never treated A.Y. and only reviewed his medical records,

likewise was only able offer a medical chronology but could not directly testify as to the

likelihood of A.Y. having experienced a varicella reactivation from the vaccine. Id. at *7.

He admitted that “he lacks specialization in the medical or scientific areas put into

dispute in this case” and recommended “contacting other professionals to conduct a

multidisciplinary interaction amongst them to ascertain the issues in this case.” Id.

(internal citations omitted). As part of his report, Dr. Honaker attached an article co-

3Because of deficiencies with these filings, A.Y.’s medical records were refiled on February 20,

2019. ECF Nos 32, 33. Chief Special Master Corcoran noted that even after refiling, it was

“impossible to conclude that the records are now complete.” A.Y., 2020 WL 5351342 at *1 n.4.

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authored by Dr. Gershon, Varicella-Zoster Virus and the Enteric Nervous System, 218 J.

Infect. Diseases, Supp. 2, S113-19 (Nov. 2018) (the “Gershon Article”), relevant to her

opinion of varicella reactivation. A.Y., 2020 WL 5351342 at *7–*8. The Gershon Article

primarily focused on the latency of the varicella virus but also mentioned “that

vaccination has been found to be capable of latency and reactivation.” Id. at *8. Chief

Special Master Corcoran noted that the medical articles cited in the Gershon Article for

the proposition that varicella vaccine is capable of latency and reactivation were not

filed as part of the record. Id.

Dr. Gershon offered her expert opinion based on having “researched [Varicella

Zoster Virus], Zoster, and latency and reactivation throughout her career.” Id. at *7. In

her opinion, “it is medically understood that the wild varicella virus can stay latent for

long periods of time . . . but can then be reactivated to cause infection.” Id. at *8.

Dr. Gershon presumed that, by extension, the live viral components of the varicella

vaccine could act in the same manner. Id. Dr. Gershon further reported that after

reviewing A.Y.’s 2015 biopsy, she found that he “was experiencing an ‘active’ varicella

infection” and that this conclusion was further bolstered by a 2016 saliva test, at which

time A.Y. tested positive for varicella. Id. Chief Special Master Corcoran noted that that

record did not contain a contemporaneous report from Dr. Gershon regarding her

analysis of the 2015 biopsy; rather, Dr. Gershon had submitted a one-page report dated

November 9, 2017, in which she documented her findings from two years earlier. Id.

Chief Special Master Corcoran further noted that “[n]o backup materials relating to this

[2015] testing” or any evidence of the 2016 saliva tests was submitted for the record. Id.

3. The Chief Special Master’s Decision

On June 26, 2020, Chief Special Master Corcoran rendered his decision, denying

entitlement for compensation. A.Y., 2020 WL 5351342 at *1. Chief Special

Master Corcoran found that, as an initial matter, the [* * *] failed to establish by a

preponderance of evidence that A.Y. suffered a varicella-type rash in 2015. A.Y., 2020

WL 5351342 at *20. Moreover, Chief Special Master Corcoran determined that the [* *

*]’ timeframe argument – that there could exist a seven-year gap between the alleged

onset of varicella and A.Y. receiving the vaccine – was not medically accepted. Id. at

*21. Chief Special Master Corcoran noted that the expert opinions of Drs. Robinson and

Honaker did not go to the issue of causation. Id. at *24. While he acknowledged

Dr. Gershon’s expert opinion in this matter, Chief Special Master Corcoran ultimately

determined that her report based on the 2015 biopsy findings “suffer[s] from reliability

concerns” and that her theory of varicella vaccine reactivation was unproven, at least as

applied to the facts of this case involving a seven-year gap between vaccination and

reactivation. Id. at *20–*21, *24. He also found that the “dizzying plethora of

treatments” that A.Y. received for his “autism-related developmental problems and

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gastrointestinal symptoms” during that seven-year span reasonably could have served

as intervening causes for the varicella-like rash. A.Y., 2020 WL 5351342 at *22.

Finally, Chief Special Master Corcoran concluded that the [* * *] failed to

establish, by preponderant evidence, their significant aggravation claim that the

varicella vaccine reactivation impacted A.Y.’s preexisting gastrointestinal and

behavioral issues. Id. at *22. Chief Special Master Corcoran reasoned that the record

evidence supported that A.Y. experienced serious behavioral and gastrointestinal issues

before the purported 2015 reactivation and that the [* * *] thus had failed to

demonstrate that A.Y.’s alleged worsening symptoms were attributable to a reactivation

of varicella. Chief Special Master Corcoran also opined that the alleged aggravation of

A.Y.’s symptoms could just as likely be attributable to the treatments for “A.Y.’s autism

and other conditions that certain of their treaters, like Dr. Krigsman have associated

with [autism].” Id. at *22–*23.

4. Petitioners File A Motion For Review

On July 27, 2020, Petitioners filed a motion for review of the Chief Special

Master’s decision pursuant to Rule 23 of the Court of Federal Claims, Appendix B

(“Vaccine Rules”). ECF No. 48 (“Pet. Mot.”) at 1. In seeking such review, Petitioners

argue that the Chief Special Master: (1) abused his discretion by misconstruing A.Y.’s

claim as arising from autism instead of a “varicella reactivation causing a varicella-like

rash”; (2) abused his discretion by relying on scientific and medical literature that

Petitioners did not introduce into the record; and (3) incorrectly required A.Y. to prove

his injury by “direct evidence” rather than a “preponderance of the evidence” standard

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

Pet. Mot. at 3. Accordingly, Petitioners ask this Court to reverse the Chief Special

Master’s decision regarding their varicella reactivation claim, or, in the alternative,

remand the case for further consideration. Id. at 2. Petitioners did not seek review of

the denial of their significant aggravation claim.

On August 26, 2020, the government filed its response to Petitioners’ motion for

review. ECF No. 51 (“Resp. Br.”) at 1. On November 12, 2020, the Court held oral

argument. ECF No. 54.

II. Jurisdiction And Standard Of Review

This Court possesses jurisdiction, pursuant to the Vaccine Act, to review a special

master’s decision upon the filing of a petition from the unsuccessful party within thirty

days of that decision. 42 U.S.C. § 300aa-12(e)(1). The Court may: “(A) uphold the finds

of fact and conclusions of the special master . . ., (B) set aside the findings of fact or

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conclusions of law . . ., or (C) remand the petition to the special master for further action

in accordance with the court’s direction.” Id. § 300aa-12(e)(2). Legal conclusions are

reviewed de novo, whereas discretionary decisions are reviewed for abuse of discretion.

Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). The

special master’s factual findings are reviewed under the highly deferential “arbitrary

and capricious” standard. Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343,

1350 (Fed. Cir. 2011); Tullio v. Sec’y of Health & Human Servs., 149 Fed. Cl. 448, 456 (2020)

(“The arbitrary and capricious standard is well understood to be the most deferential

possible.” (internal quotation marks omitted)).

III. Petitioners’ Motion For Review

The Vaccine Act provides a framework permitting petitioners to seek

compensation for a vaccine-related “illness, disability, injury, or condition” that lasts

“more than 6 months.” 42 U.S.C. §§ 300aa-11(c)(1)(C), (c)(1)(D)(i); see Broekelschen v.

Sec’y of Health & Human Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010) (“identifying the

injury is a prerequisite to the [causation] analysis”). For vaccines administered after

October 1, 1988, petitions must be filed within “36 months after the date of the

occurrence of the first symptom . . . of such injury.” 42 U.S.C. § 300aa-16(a)(2). For

injuries not already recognized by the Vaccine Injury Table, see id. § 300aa-14, such as

the case at issue here, “the petitioner must prove actual causation by a preponderance

of the evidence.” W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir.

2013); see Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)

(holding that “preponderant evidence” necessitates more than a “’plausible’ or

‘possible’ causal link between the vaccine and the injury”). To prove causation in fact,

the petitioner must provide: “(1) a medical theory casually 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 proximate temporal relationship

between vaccination and injury.” Althen v. Sec’y of Health & Human Servs., 418 F.3d

1274, 1278 (Fed. Cir. 2005). The third Althen prong requires “preponderant proof that

the onset of symptoms occurred within a framework 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)

(emphasis added); see Veryzer v. Sec’y of Health & Human Servs., 100 Fed. Cl. 344, 356

(2011) (“Merely showing that injury occurred after the administration of a vaccine is

insufficient.”).

The [* * *] argue that the Chief Special Master overemphasized A.Y.’s

preexisting autism diagnosis when evaluating the varicella vaccine claim. Pet. Mot. at

13–16. Furthermore, the [* * *] contend that the Chief Special Master improperly

relied on medical literature and reports not contained in the record, and which the [* *

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*] argue they did not have an opportunity to address. Id. at 16–18. Finally, the [* * *]

assert that the Chief Special Master improperly discredited Dr. Gerson’s expert

testimony. Id. 18–19. While the Court sympathizes deeply with the [* * *] regarding

A.Y.’s numerous medical issues, the Court finds that the Chief Special Master’s decision

was not arbitrary, capricious, or an abuse of discretion, and, accordingly, the Court

sustains his decision for the reasons explained below.

A. The Chief Special Master Did Not Act Arbitrarily By Referencing

A.Y.’s Autism Diagnosis

The [* * *] argue that the Chief Special Master abused his discretion, as “his

entire review of the medical records in this case cast it almost exclusively as an autism

case, i.e. that Petitioners are alleging A.Y.’s autism was caused by his vaccinations.”

Pet. Mot. at 15. The [* * *] note that the Chief Special Master used the terms “autism”

and “autism spectrum disorder” a combined 41 times in the decision, that he “is highly

critical of two of A.Y.’s treating doctors . . . as they pertain to autism,” and that the Chief

Special Master made “several negative statements about the treatments [they] sought

for him – for his autism.” Id. at 13–15 (emphasis in original). In their view, this

demonstrates that autism “was the lens through which [the Chief Special Master]

viewed the evidence.” Id. at 16.

Although the [* * *] invoke the “abuse of discretion” standard, that standard is

limited to discretionary decisions and “rarely come[s] into play.” Munn, 970 F.2d at 870

n.10 (holding that exclusion of evidence is subject to abuse of discretion standard); see

also Harding v. Sec’y of Health & Human Servs., 146 Fed. Cl. 381, 393–94 (2019)

(“contesting a special master’s determination of reasonable attorney’s fees, the

applicable standard of review is abuse of discretion”). Because the [* * *] in essence

contest the Chief Special Master’s findings of fact, this Court properly evaluates his

weighing of the evidence and resulting factual conclusions pursuant to the “arbitrary

and capricious” standard of review. See Munn, 970 F.2d at 870 n.10.

Accordingly, on a motion to review, this Court “do[es] not reweigh the factual

evidence, assess whether the special master correctly evaluated the evidence, or

examine the probative value of the evidence or credibility of the witnesses–these are all

matters within the purview of the fact finder.” Porter v. Sec’y of Health & Human Servs.,

663 F.3d 1242, 1249 (Fed. Cir. 2011); see Cedillo v. Sec’y of Health & Human Servs., 617 F.3d

1328, 1338 (Fed. Cir. 2010) (“Our role is not to second guess the Special Master’s fact-

intensive conclusions[.]” (brackets and quotation marks omitted)). Because “the special

masters have broad discretion to weigh evidence and make factual determinations,”

Dougherty v. Sec’y of Health & Human Servs., 141 Fed. Cl. 223, 229 (2018), “reversible error

will be extremely difficult to demonstrate.” Hibbard v. Sec’y of Health & Human Servs.,

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698 F.3d 1355, 1363 (Fed. Cir. 2012). In sum, “if the special master’s conclusion is based

on evidence in the record that is not wholly implausible, [this Court is] compelled to

uphold that finding as not being arbitrary and capricious.” Deribeaux v. Sec’y of Health &

Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013) (brackets and quotation marks

omitted).

The Court does not deny that the Chief Special Master continuously references

A.Y.’s autism throughout his decision. And, indeed, the Court concurs with Petitioners

that the case law does not “support the denial of a petitioners [sic] claim on the basis of

preexisting autism.” Pet. Mot. at 16. That is, of course, where a petitioner’s claim does

not involve an allegation that a vaccine precipitated autism. See, e.g., Yates v. Sec’y of

Health & Human Servs., 150 Fed. Cl. 575, 577–78 (2020) (reviewing petition of individual

with “a history of autism” for injuries allegedly caused after receiving the Menactra

vaccine); Spahn v. Sec’y of Health & Human Servs., 133 Fed Cl. 588, 591–92 (2017)

(reviewing petition of individual, who was diagnosed with autism, claiming that

tetanus-diphtheria vaccine significantly aggravated obsessive-compulsive disorder). In

this case, however, the [* * *] asserted two claims for compensation based on the

alleged reactivation of the varicella vaccine: (1) A.Y.’s alleged varicella skin rash, and

(2) significant aggravation of A.Y.’s autism-related behavioral and intestinal issues. See A.Y.,

2020 WL 5351342 at *1. Thus, to be fair, the [* * *] themselves placed A.Y.’s autism at

the center of their petition for compensation. The Chief Special Master was, in turn,

required to evaluate the onset and severity of A.Y.’s autism-related issues in

determining the legitimacy of the significant aggravation claim. Once the [* * *]

submitted related medical records and supporting materials into the record, it is

unsurprising (if not required) that the Chief Special Master also considered whether the

myriad of autism treatments provided a possible alternative explanation for the alleged

skin rash or exacerbated behavioral and other symptoms.

Arguing that the Chief Special Master mischaracterized Dr. Gershon’s expert

opinion, the [* * *] are highly critical of the Chief Special Master’s observation that

“[t]he causation theory in this case has numerous ‘echoes’ with such previously-litigated

[autism] claims.” Pet Mot. at 16 (emphasis added) (quoting A.Y., 2020 WL 5351342 at

*24 n.34). And, when read in a vacuum, that comment certainly appears to be

supportive of the [* * *]’ argument. A closer examination of the Chief Special Master’s

decision, however, demonstrates that he appropriately qualified his observation, as

follows:

My determination not to hold a hearing was also influenced

in minor part by the undeniable fact that this case presents

circumstances common to many other ASD injury cases

previously litigated in the Program, in which well meaning

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parents pursue questionable medical treatments that may

themselves have unpredictable complications, while also insisting

that vaccination played some role in the child's condition. . . . The

causation theory in this case has numerous “echoes” with

such previously-litigated claims—in particular to the extent it

sought to establish that certain aspects of A.Y.’s ASD-related

behaviors were worsened by the purported varicella reactivation—

and those parallels underscored for me why resolution on the

papers was preferable to hearing.

A.Y., 2020 WL 5351342 at *24 n.34 (emphasis added) (internal citation omitted). The

“echoes” that the Chief Special Master referenced were the [* * *]’ significant

aggravation claim of A.Y.’s preexisting behavioral issues and the myriad of

controversial treatments that A.Y. received during the seven years in between

vaccination and the alleged reactivation. Additionally, the Chief Special Master does

not appear to have relied on similarities between the present case and previous autism

cases to deny the [* * *]’ petition; rather his observation was made merely in the

context of deciding that a hearing was unnecessary. In sum, the Chief Special Master

did not act arbitrarily in weighing all of the autism-related medical information that

was provided by the [* * *].

B. The Chief Special Master Did Not Commit Reversable Error By

Consulting Medical Literature Outside Of The Pleadings

The [* * *] next contend that the Chief Special Master abused his discretion by

improperly consulting medical literature, websites, and reports not submitted by

Petitioners or the government. Pet. Mot. at 16–18. The [* * *] assert that due process

considerations required the Chief Special Master to have provided the [* * *] with a

meaningful opportunity to examine and address all materials that he relied upon in

reaching his decision to deny A.Y. compensation. Id. The [* * *] maintain that they

were not provided with such an opportunity, and, thus, that the Chief Special Master’s

decision should be reversed. Id.

Our appellate court, the United States Court for the Federal Circuit, has held that

“[i]t is axiomatic that special masters in vaccine cases have great leeway in building a

record for decision.” Davis v. Sec’y of Health & Human Servs., 94 Fed. Cl. 53, 65 (2010),

aff’d, 420 F. App’x 973 (Fed. Cir. 2011). In admitting evidence for the record, special

masters are provided “flexible and informal standards,” 42 U.S.C. § 300aa-12(d)(2)(B),

and are “not . . . bound by common law or statutory rules of evidence.” Vaccine Rule

8(b)(1). This flexibility must be balanced with the directive that “core concepts of due

process apply to proceedings before a special master.” Davis, 94 Fed. Cl. at 65. In that

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regard, a special master is required to “provide adequate notice to the parties of

evidentiary issues” and “to decide [the case] on the record.” Id. (citing 42 U.S.C. §§

300aa-12(d)(3)(B)(iv),(v), and 300aa-13(a)(1)); see Campbell v. Sec’y of Health & Human

Servs., 69 Fed. Cl. 775, 778 (2006) (“Moreover, consistent with due process, this fairness

surely entails notice and an effective opportunity to be heard at a meaningful time and

in a meaningful manner.”).

Within this framework, the Federal Circuit has recognized that it may be

appropriate for special masters to take judicial notice of certain facts without notifying

the parties. Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1526 (Fed. Cir. 1991);

see Rodriguez v. Sec’y of Health & Human Servs., 91 Fed. Cl. 453, 460 (2010) (“the [Federal

Circuit] has approved the taking of judicial notice in a case arising under the Vaccine

Act”). Judicial notice of facts that are “not subject to reasonable dispute” from “sources

whose accuracy cannot reasonably be questioned,” does not violate due process, the

Federal Circuit reasoned, because the party still has the opportunity to challenge any

prejudice arising from that information on review before the Court of Federal Claims.

Hines, 940 F.2d at 1526. Indeed, the Federal Circuit noted that “[w]ell-known medical

facts are the types of matters which judicial notice may be taken.” Id.

In his decision, the Chief Special Master cited seven sources that were not

presented by the parties. See A.Y., 2020 WL 5351342 at *17–*18, *21, *21 n.29.

Specifically, in the section of his decision entitled “Varicella Reactivation and Relevant

Varicella Vaccine Cases,” the Chief Special Master considered two medical textbooks –

Atlas of Pediatric Physical Diagnosis 444 (5th ed. 2007) and Nelson Textbook of

Pediatrics 1579–84 (R. Kliegman et al., 20th ed. 2016) – to establish generally accepted

propositions about the varicella virus, including its symptoms, potential for latency and

reactivation, and common treatments. Id. at *17. Because this information was sourced

in two medical textbooks, “both are within the bounds of judicial notice as they contain

commonly known information which need not be proved.” Griffin v. Sec’y of Health &

Human Servs., 124 Fed. Cl. 101, 107 (2014) (citing B.V.D. Licensing Corp. v. Body Action

Design, 846 F.2d 727, 728 (Fed. Cir. 1988)).

The Chief Special Master also cited three websites not presented by the parties.

A.Y., 2020 WL 5351342 at *18, *21. One such website was a government website – the

Federal Drug Administration website. Id. at *21. The Chief Special Master consulted

that website for generally available information about the viral contents of the varicella

vaccine (known as varivax). Id. The other two websites were the Mayo Clinic website

and an online microbiology journal available on a website associated with the National

Institutes of Health. Id. at *18. As with the medical dictionaries, the Chief Special

Master utilized these online sources to further explain the ability of the varicella virus to

remain latent and reactivate after lengthy periods of inactivity. Id. Again, because the

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accuracy of this information available through these reputable sources is not seriously

subject to debate, the Chief Special Master did not err in taking judicial notice of their

contents.4 See Griffin, 124 Fed. Cl. at 107.

More significantly, in the [* * *]’ motion for review – other than asserting that

they were not afforded an opportunity to examine these medical textbooks and online

materials before the Chief Special Master rendered his decision – the [* * *] fail to

explain (or even allege) precisely how they were prejudiced by the Chief Special

Master’s consideration of these materials.5 See Pet. Mot. at 16–18. On the contrary, as

the government correctly notes in its response, these materials were at least partially “to

the advantage of petitioners” in that they provided some factual support about the

latency and reactivation capabilities of the varicella virus. Resp. Br. at 11.

Finally, the Chief Special Master considered two of the references footnoted by

the Gershon Article, which the [* * *] submitted for the record as part of

Dr. Honaker’s expert opinion. A.Y., 2020 WL 5351342 at *21 n.29. For the proposition

that varicella vaccine could remain latent and reactivate in the same manner as varicella

virus, the Gershon Article referred to two medical journal articles: I. Kamiya et al.,

Viremic Phase in Leukemic Child After Live Varicella Vaccination, 89 Pediatrics 147 (1992),

and S. Weinmann et al., Incidence and Clinical Characteristics of Herpes Zoster Among

Children in the Varicella Vaccine Era, 208 J. Infectious Disease 1859 (2013). Upon

reviewing those unfiled articles, the Chief Special Master observed, in a footnote, that

neither article “appear to stand strongly for the proposition that a vaccine administered

years before could have the same reactivation potential as the wild virus” and thus

“does not identify strong support for Dr. Gershon’s assertions.” A.Y., 2020 WL 5351342

at *21 n.29. These articles, however, were not filed by the [* * *] and the Chief Special

Master did not notify them that he would consider or otherwise address these sources

as part of his decision. See Pet. Mot. at 17 n.12 (asserting that the Chief Special Master’s

critique of these sources was prejudicial to their claim).

This gives the Court some pause. On the one hand, a learned colleague of this

Court has concluded, on facts similar to those at issue here, that it is improper for a

special master to undertake a review of materials that were not expressly submitted for

4The Court notes, however, that it would be inappropriate for a special master to take judicial

notice of information posted on unreliable websites. See Campbell, 69 Fed. Cl. at 780-82 (finding

that a special master committed reversable error in relying on information, not submitted by the

parties, from Wikipedia and other websites which contained reliability disclaimers).

5Because the [* * *] have not attempted to respond substantively to the medical information

that the Chief Special Master consulted, such failure likely constitutes waiver. See Hines, 940

F.2d at 1526; see also Vaccine Rule 8(f).

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the record. See Davis v. Sec’y of Health & Human Servs., 94 Fed. Cl. 53, 64–66 (2010)

(Lettow, J.) (holding that it was improper for the special master to draw an adverse

inference from a medical study, which was cited in an article included in the record, not

itself submitted by the petitioner). On the other hand, in the special master’s role as fact

finder, he or she must examine an expert opinion’s analysis and not just accept the

expert’s ipse dixit conclusions. See Isaac v. Sec’y of Health & Human Servs., 108 Fed. Cl.

743, 768 (2013) (“[A] special master does not need to credit expert opinion testimony

that is connected to the existing data or methodology only by the ipse dixit of the

expert . . . .” (internal citation marks and footnote omitted)). To the extent that the

Gershon Article effectively incorporated other articles by reference to support its

analysis, the Court cannot conclude that the Chief Special Master improperly reviewed

those cited articles as well. Cf. Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d

1272, 1282 (Fed. Cir. 2010) (“Incorporation by reference provides a method for

integrating material from various documents into a host document . . . by citing such

material in a manner that makes clear that the material is effectively part of the host

document as if it were explicitly contained therein.” (emphasis added)); Love Terminal

Partners v. United States, 97 Fed. Cl. 355, 385 (2011) (noting that “Courts ‘have allowed

consideration of matters incorporated by reference or integral to the claim’” in deciding

a motion to dismiss (quoting 5B Charles A. Wright & Arthur R. Miller, Federal Practice

& Procedure § 1357 (3d ed. 2004))). If a special master were not permitted to evaluate

the substance and articulated rationale supporting a particular piece of scientific

evidence, that would be tantamount to concluding that a special master must accept an

expert’s ipse dixit. Put differently, the Court does not see why a special master’s review

of citations that Petitioners themselves effectively have placed into the record is all that

different from checking an expert’s math.

The Court need not definitively resolve that issue, however, because just as

Judge Lettow ultimately concluded in Davis, 94 Fed. Cl. at 66, even if the citations the

Chief Special Master considered are deemed outside of the record – and thus

improperly considered – it was harmless error. When “the special master’s decision

was based on a number of factors and [petitioner] has not shown that the reliance on the

[information] . . . was likely critical to the result,” such a mistake constitutes “harmless

error” and does not justify reversing the special master’s decision. Hines, 940 F.2d at

1526; see Doe v. Sec’y of Health & Human Servs., 601 F.3d 1349, 1356 n.2 (Fed. Cir. 2010)

(holding that the special master taking judicial notice of table of brain weights “was

harmless[, as t]his table was not the only fact the special master relied on, or even the

most important one, in declining to credit Dr. Shane’s theory” (internal citation

omitted)); see also Broekelschen, 618 F.3d at 1346–47 (characterizing assessment of witness

demeanor as “at most . . . harmless error”); Cedillo, 617 F.3d at 1342–44 (“any error in

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considering the . . . testimony was, in fact harmless, as it did not affect the outcome of

the proceeding”).

In this case, the Court concludes that there is significant other evidence in the

record, as detailed in the following section, that the Chief Special Master relied upon in

rejecting Dr. Gershon’s causation theory in this case. See infra Section III.C. Moreover,

the Chief Special Master made his observations of the Gershon Article based on his

review of the two unfiled articles in a footnote, not in the body of his decision, further

indicating that these referenced articles played a minimal role in his ultimate decision.

Given the totality of the record evidence and the [* * *]’ failure to show that the Chief

Special Master substantially relied on his outside-the-record research in reaching his

ultimate decision, the Court concludes that, even if this action was improper, it was

harmless error.

C. The Chief Special Master Did Not Act Arbitrarily In His Evaluation

Of Dr. Gershon’s Expert Opinion

“[A]s the finder of fact, the special master [is] responsible for assessing the

reliability of [the expert's] testimony by looking for reliable medical or scientific

support.” Lalonde v. Sec'y of Health & Human Servs., 746 F.3d 1334, 1340 (Fed. Cir. 2014).

The special master “is not required to accept an expert's opinion simply because the

expert is found qualified to opine in a medical or scientific discipline.” Bean-Sasser v.

Sec’y of Health & Human Servs., 127 Fed. Cl. 161, 165 (2016). While “[a] finding of

preponderant evidence of causation in fact may be based on medical opinion

alone[,] . . . the special master is entitled to require some indicia of reliability to support

the assertion of the expert witness.’” Davis, 94 Fed. Cl. at 63 (internal citation omitted)

(quoting Moberly, 592 F.3d at 1324); see Snyder v. Sec’y of Health & Human Servs., 88 Fed.

Cl. 706, 743 (2009) (“A [special master] may conclude that there is simply too great an

analytical gap between the data and the opinion proffered.” (quotation omitted)).

When it is evident that the special master “clearly considered all of the pertinent

evidence provided[, t]his Court cannot reweigh the evidence at hand to arrive at a new

conclusion without infringing upon the great deference afforded special masters in

making compensation decisions.” Caruso v. Sec’y of Health & Human Servs., 137 Fed Cl.

386, 394 (2018) (emphasis in original).

The [* * *] contend that the Chief Special Master did not afford appropriate

deference to Dr. Gershon’s expert testimony that: (1) it is medically acceptable that the

varicella vaccine could reactive many years later; and (2) A.Y. was actively experiencing

a varicella infection in 2015. Pet. Mot. at 18–20. Petitioners attempt to frame this

argument as the Chief Special Master’s having “committed legal error” by raising their

“burden of proof by requiring direct evidence and scientific confirmation . . . rather than

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a preponderance of the evidence.” Pet. Mot. at 18, 20. Under such a theory, this Court

would need to undertake a de novo review. See Munn, 970 F.2d at 870 n.10. However, a

fair reading of the [* * *]’ argument reveals that they essentially contest the Chief

Special Master’s assessment of Dr. Gershon’s credibility. Accordingly, as with any time

this Court is asked to reweigh the special master’s evaluation of an expert’s

persuasiveness, this claim is properly viewed under the deferential “arbitrary and

capricious” standard of review. See Milik v. Sec’y of Health & Human Servs., 822 F.3d

1367, 1380 (Fed. Cir. 2016).

Petitioners assert that Dr. Gershon is “a leading expert in the field [of varicella

latency and reactivation] who remains unchallenged in the record.” Pet. Mot. at 19.

The Chief Special Master, however, acknowledged both Dr. Gershon’s credentials and

her conclusion that it was medically accepted that the varicella virus could remain

dormant and reactivate years later. A.Y., 2020 WL 5351342 at *7, *17–*18. Nevertheless,

based on the record, the Chief Special Master also found that “Petitioners have offered

no evidence establishing what period of time from vaccination to reactivation would be

medically acceptable” in terms of attributing the reactivation to the vaccine. Id. at *21

(emphasis in original). The Chief Special Master further expanded on this point, noting

that, because “varicella vaccine (which includes a live but attenuated varicella virus

strain) is intended to be less virulent than the wild virus . . . it cannot simply be assumed

that the same latency periods apply to both.” Id. (emphasis in original). He also

determined that, given “the timeframe in question (from vaccination to onset) is so

lengthy,” Dr. Gershon failed to appropriately consider all the various treatments that

A.Y. received during that time. Id. at *22. In light of those myriads of treatments, many

of which the Chief Special Master characterized as “lack[ing] general medical

community or [autism] treater acceptance,” he was unable to conclude that there was

“no possible intervening triggers” for the skin rash. Id. (emphasis in original).

Regarding the [* * *]’ other contention that “[o]bjective medical testing showed

that A.Y. had an active [varicella] infection,” Pet. Mot. at 19, the Chief Special Master

explained that the record entirely lacks a confirmed diagnosis that the marks and rashes

which A.Y. experienced in 2015 were actually varicella. A.Y., 2020 WL 5351342 at *20.

Additionally, the Chief Special Master observed, that A.Y. did not suffer from other

indicia of a varicella infection, like fever, and that “[n]o blood testing, antibody

findings, or other serologic evidence has been offered to corroborate that a varicella

infection existed as of the winter of 2015.” Id. On the contrary, the Chief Special Master

noted Dr. Tachdjian’s opinion that A.Y.’s antibody tests “were not consistent with the

conclusion that A.Y. had experienced a varicella infection.” Id. (emphasis in original).

Furthermore, even assuming that the skin rash was varicella, the Chief Special Master

noted that, because the record revealed that the rash cleared up quickly with Acyclovir,

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there was no basis for recovery pursuant to the Vaccine Act’s six-month rule. Id. (citing

42 U.S.C. § 300aa-11(c)(1)(D)(i)). Conversely, the Chief Special Master reasoned, to the

extent that the record demonstrated that A.Y. had been using Acyclovir “throughout his

life,” that would suggest that he had initial symptoms of varicella infections earlier in

life, prior to 2015, thus barring compensation under the Vaccine Act’s three-year statute

of limitations period. Id.

While the Chief Special Master acknowledged Dr. Gershon’s findings of varicella

strains in A.Y.’s intestine during the winter of 2015, the Chief Special Master reasoned

that the report suffered from “reliability concerns.” Id. Dr. Gershon had created the

report in 2017, two years after her review of the 2015 biopsy report and included “no

substantive back-up data for the findings has been filed, making it impossible to

confirm the accuracy of these representations.” Id. Moreover, the [* * *] did not

provide any further corroborating evidence that the alleged evidence of the varicella

strains in A.Y.’s intestine related to virus reactivation, especially when considering all

the possible intervening causes during the prior seven years. Id.

In sum, while the [* * *] clearly would have preferred that the Chief Special

Master have afforded more weight to Dr. Gershon’s theory linking latency and

reactivation of the varicella virus and the varicella vaccine and her analysis of A.Y.’s

2015 biopsy, the Chief Special Master evaluated all the medical information available in

the record in reaching his reasoned conclusion. The Chief Special Master did not

simply disagree with Dr. Gershon’s conclusions; rather, he scrutinized her theory and

accompanying analysis as applied to the specific facts of this case “and reached the

reasonable conclusion that, in the absence of supporting studies or other evidence, [her]

expert testimony was unreliable.” Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl.

119, 133–34 (2011), aff’d, 463 F. App’x 932 (Fed. Cir. 2012). Because “[d]etermining what

weight should be afforded to the testimony of a fact witness, expert witness, or medical

records is a finding well within the discretion of the Special Master, . . . this Court will

not endeavor to infringe upon that well-established discretion.” Caruso, 137 Fed Cl. at

393.

CONCLUSION

For all the above reasons, the Court DENIES Petitioners’ motion for review and

sustains the Chief Special Master’s decision. The Clerk shall enter JUDGMENT for

Respondent accordingly.

IT IS SO ORDERED.

s/ Matthew H. Solomson

Matthew H. Solomson

Judge

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