FIORELLO v. SECRETARY OF HEALTH AND HUMAN SERVICES

In the United States Court of Federal Claims

)

STEPHANE AND ANTHONY FIORELLO, )

on behalf of their minor child, R.F., )

)

Petitioners, ) No. 17-1869V

) (Filed Under Seal: February 20,

v. ) 2025. Reissued for Publication

) 3/10/2025) *

SECRETARY OF HEALTH AND HUMAN )

SERVICES, )

)

Respondent. )

)

Courtney Christine Jorgenson, Siri & Glimstad, LLP, Phoenix, AZ, for Petitioners.

Ryan Pohlman Miller, Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice,

Washington, DC, with whom were Julia C. Collison, Assistant Director, Heather L. Pearlman,

Deputy Director, C. Salvatore D’Alessio, Director, for Respondent.

OPINION AND ORDER

This case arises under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§

300aa-1 to -34 (“Vaccine Act” or “the Act”). It is currently before the Court on the Petitioners’

motion for review. Pet’rs’ Mot. for Rev., ECF No. 85. Petitioners challenge Special Master

Daniel T. Horner’s decision that they failed to prove that the hepatitis B vaccine caused their son

R.F. to experience chronic dysregulation of his immune system characterized by recurrent

hypersensitive reactions to viral infections. See Decision of Spec. Mstr., ECF No. 83 [hereinafter

“Dec.”]; see also Fiorello v. Sec’y of Health & Hum. Servs., 2024 U.S. Claims LEXIS 2330,

2024 WL 4133302 (Fed. Cl. Spec. Mstr. Aug. 12, 2024).

For the reasons set forth below, the Court finds that the special master’s decision was

neither arbitrary and capricious, nor contrary to law. Petitioners’ motion for review is therefore

DENIED.

*

Pursuant to Vaccine Rule 18(b), this opinion was initially filed on February 20, 2025, and the

parties were afforded fourteen days to propose redactions. The parties did not propose any

redactions and, accordingly, this Opinion is reissued in its original form for publication.

BACKGROUND

I. Medical History

On December 8, 2008, R.F., the third of a set of triplets, was born by cesarean section at

29 weeks. Pet’rs’ Ex. 14, at 13, ECF No. 16-1. After his birth, R.F. was put in the NICU, where

he was treated for respiratory distress syndrome, hyperbilirubinemia, choroid plexus cyst,

retinopathy of prematurity, apnea, tachycardia, and feeding difficulties—all of which are

common in premature births. Id. R.F. responded well to treatment and was discharged on January

20, 2009. Id. at 12. He experienced developmental delays common in premature births and by his

five-year well visit had been diagnosed with fine and gross motor delays, a sensory processing

disorder, attention deficit hyperactivity disorder, and mild anxiety. Pet’rs’ Ex. 17, at 52–57, ECF

No. 18-1.

On December 4, 2014, R.F. received his second dose of the hepatitis B vaccine. Pet’rs’

Ex. 5, at 14, ECF No. 9-1. 1 About 23 hours later, on December 5, 2014, Pet’rs’ Ex. 11, at 11,

ECF No. 13-1, R.F. was taken to urgent care where he presented with “[a]ltered mental status

with episodes of pallor,” Pet’rs’ Ex. 3, at 2, ECF No. 8-3. R.F. was described as “oriented to

time, place and person” but it was noted that he “[i]ntermittently” became less responsive. Id. A

full blood culture was not obtained “because infectious etiology was lower on the differential

initially,” but a complete blood count and a comprehensive metabolic panel were obtained. See

id. at 2–3. The tests revealed an abnormally high white blood cell count which, according to the

pediatrician who examined R.F., might “point towards infectious etiology or [might] represent

stress response.” Id. at 2. Otherwise, the results of R.F.’s exams, including a nonfocal exam and

an electrocardiogram, were normal. Id.

After the urgent care examination, R.F. was transferred to a hospital emergency room.

See id. at 4. The ambulance team described his “accident or illness” as “syncope and collapse,”

but noted that R.F.’s condition was improved and that he was alert when examined. Pet’rs’ Ex.

11, at 1–2. R.F. was described as “warm, dry, pale in color” and “acting normal according to his

mother.” Id. at 4. At the hospital, at around 6:30 PM, he was described as “awake[,] alert[,] and

oriented.” Id. at 8. Blood tests revealed that his white blood cell count was continually

improving. Id. at 12. The results of other examinations were normal. See id. at 8–15.

The hospital records also note that R.F. had been experiencing a cough with no associated

fever since the second week in September. Id. at 13. Though no official diagnosis was provided,

the attending doctor stated that “differential diagnosis includes syncope, seizure, or intercurrent

illness not evident on . . . evaluation” and R.F. was discharged the same day around 10:30 PM

with orders for a sleep-deprived electroencephalogram (“EEG”) and a follow-up with his

pediatrician. Id. at 12, 15, 22.

Several months later, on March 6, 2015, R.F. had a check-up with his pediatrician during

which he presented with symptoms of an upper respiratory infection. See Pet’rs’ Ex. 5, at 17–19.

1

R.F. received his first dose of the hepatitis B vaccine on August 28, 2014. Pet’rs’ Ex. 5, at 11;

see also Pet’rs’ Ex. 1, at 2–3, ECF No. 8-1.

2

R.F.’s mother reported to the pediatrician that he had experienced another incident on December

5, during which he was pale, cold, hypotonic, and less responsive than usual. Id. R.F. again

recovered completely from the episode after a few hours. Id.; see also Pet’rs’ Ex. 1., at 5.

The pediatrician diagnosed R.F. with an unspecified upper respiratory infection and a

“hypotonic/hyporesponsive episode,” and recommended ruling out a seizure disorder or other

neurological problems. Pet’rs’ Ex. 5, at 18. R.F.’s physical exam was otherwise normal. Id. at

17–19. Subsequently, on March 27, 2015, R.F. underwent an EEG. Pet’rs’ Ex. 9, at 95–96, ECF

No. 11-3. The EEG report noted R.F. had a history of migraine headaches but identified no other

neurological issues. Id.

On April 2, 2015, R.F. consulted with Dr. John Oppenheimer, an allergy and

immunology specialist. The purpose of the consultation was to provide Petitioners with direction

regarding R.F.’s future vaccinations. Pet’rs’ Ex. 2, at 2, ECF No. 8-2. Dr. Oppenheimer

diagnosed R.F. with severe seasonal allergic rhinoconjunctivitis but did not formally diagnose

R.F. with any condition related to his hypotonic/hyporesponsive episodes. Id. In his assessment,

Dr. Oppenheimer wrote:

Status post episode of hypotonia with systemic complaints following vaccination

to hepatitis B. Certainly, it is easy to blame the hepatitis vaccine for this; however,

mechanistically, this is by no means an allergic response. Thus, skin testing will

not aid. This certainly appears to be potentially an immune response and may speak

to why three months later he had another episode when questionably it was a viral

related illness. I am [aware] that neurology is following and I wholeheartedly

encourage continued follow up as obviously the differential is protean. Presently,

they are looking for potential seizures or migraines as etiology; however, it would

be nice to know what potential triggers may bring this about for future observation.

Id.

On May 18, 2015, R.F. was admitted to the Overlook Medical Center, with an admitting

diagnosis of “other convulsions.” Pet’rs’ Ex. 9, at 7. He was assessed for “episodes concerning

for seizures [with] pallor [and] limpness.” Id. at 15. His recorded history described the two

episodes discussed above as well as unrelated eye issues. Id. at 12. Upon the recommendation of

a physician at the facility, R.F. was hospitalized for a 48-hour video EEG, which observed him

both awake and asleep from May 18 to May 20, 2015. See id. at 31–32. The pediatric neurologist

who conducted the exam noted R.F.’s eye issues during the exam, but the video EEG displayed

normal, non-epileptic events. Id. at 16, 19, 31–32.

On May 25, 2017, R.F. paid a visit to Dr. Mercy Chong, complaining of a cough and

fever. Pet’rs’ Ex. 28, at 28–31, ECF No. 60-1. Dr. Chong reported that R.F. “goes into shock

with every new virus,” and noted that there had been an episode the preceding Saturday. Id. at

28. The doctor described these as “immune episodes,” and noted that they “[s]eem to have

started after starting Hep B Series” but that “[t]here is some disagreement between the

specialists.” Id. at 29–30. R.F. was assessed as having experienced “hypotensive episode[s]”

with “unclear etiology.” Id. at 31. The attending physician also noted that there were “no labs,

results, notes to go on.” Id.

3

Approximately two months later, on July 19, 2017, R.F. had a well-child visit with Dr.

Jeffrey Siegel at North Scottsdale Pediatrics. See Pet’rs’ Ex. 6, at 30–32, ECF No. 10-1.

Petitioners reported that R.F. could not undergo anesthesia, have vaccinations, or take new

medications. Id. They also informed the doctor that an “immunology specialist” who had

evaluated R.F. thought that he had a hyperimmune reaction, which they believed was caused by

the hepatitis B vaccine. Id.

In his assessment, Dr. Siegel opined that R.F. experienced an “immune hypersensitivity

reaction by mechanism,” and observed that the “very rare immune reaction seems to have been

triggered by Hep B vaccine.” Id. at 32. Dr. Siegel also noted that R.F.’s episodes “always self

resolve[],” and that getting a genetics opinion had been discussed. Id. He referred R.F. to Dr. S.

Reed Shimamoto, an allergist at San Tan Allergy & Asthma. Id.

On August 17, 2017, Petitioners consulted with Dr. Shimamoto for evaluation of an

immune deficiency. Pet’rs’ Ex. 4, at 4–9, ECF No. 8-4. Dr. Shimamoto noted “there has been

concern about possible relationship [between] vaccinations and these episodes but they persist

despite no recent vaccines.” Id. at 6.

Dr. Shimamoto noted that the immunologist in New Jersey (presumably Dr.

Oppenheimer) had used the term “[h]yper-immune response” and not “allergic reaction.” Id. He

observed that “no diagnosis has been made” but questioned how a vaccine could “break [R.F.’s]

entire immune system.” Id. He added that “[a]t this point, everyone is just kind of stuck and no

real answer as to why, why did it start at age 5–6 and not a congenital type of problem.” Id. at 6.

Dr. Shimamoto also provided comments on Dr. Oppenheimer’s evaluation. He observed

that Dr. Oppenheimer had conducted no tests. He further observed that Dr. Oppenheimer had

deemed R.F. “hyper-immune,” but that he (Dr. Shimamoto) was “not sure exactly what th[at]

refers to.” Id. at 5–6. Dr. Shimamoto recommended an immune screen as well as the record of

vaccine responses from his infant series to check for a pattern of specific immune-related

disease. Id. at 6.

On October 6, 2017, Petitioners took R.F. to Dr. Siegel, complaining of extreme pain in

his left arm. Pet’rs’ Ex. 6, at 28. X-rays were taken and revealed that R.F. had a fractured distal

radius and ulna. See Pet’rs’ Ex. 6, at 28–30, 40. 2

A few days later, on October 10, 2017, R.F. was evaluated at Phoenix Children’s sports

medicine practice. The orthopedist noted that R.F.’s x-rays were concerning for osteopenia. Id. at

17–18. He referred R.F. to an endocrinologist, Dr. Madhia Shahid, who saw R.F. on November

9, 2017. Pet’rs’ Ex. 7, at 25, ECF No. 11-1. Dr. Shahid noted that the “‘shock’ like episodes

which [R.F.] gets 7-8 x year could be due to hypoglycemia,” but his concern about chronic

hypoglycemia was “very low.” Id. at 25–26. Dr. Shahid also diagnosed R.F. with osteopenia. Id.

at 25.

2

R.F. had previously broken his arm on November 19, 2014, Pet’rs’ Ex. 10, at 5, ECF No. 11-4,

but reportedly that injury healed normally, see Pet’rs’ Ex. 1, at 7.

4

On April 27, 2018, R.F. was evaluated for “suspected vaccination reaction” by Dr.

Michael Daines, and Dr. Pamela Tongchinsub, an allergy and immunology fellow. Pet’rs’ Ex.

21, at 3, ECF No. 30-1. Dr. Tongchinsub concluded that “since episodes occur without inci[t]ing

incident of vaccines each time, his symptom constellation is unlikely . . . immunodeficiency or

vaccine reaction.” Id. Instead, she listed R.F.’s differential diagnoses as postural orthostatic

tachycardia syndrome (“POTS”), mast cell, congenital heart disease, and idiopathic anaphylaxis,

though she also noted the “vagueness of symptoms.” Id.

Three years later, in April of 2021, R.F. underwent genetic testing which returned normal

results. Pet’rs’ Ex. 32, at 35–67, ECF No. 79-1. The geneticist listed the differential diagnoses as

familial dysautonomia, other hypersensitivity reactions, POTS, abdominal migraines, and

mitochondrial disorders, “among others.” Id. at 54. A cardiologist evaluated R.F. on April 21,

2021, and reported that she “cannot think of any clear unifying cardiac etiology that would

explain his symptoms,” and opined that no cardiology follow up was necessary. Id. at 22.

Dr. Siegel saw R.F. for a wellness check on August 18, 2021, and again assessed R.F.

with “immune hypersensitivity reaction by mechanism,” with diagnostic code “T78.40XD:

Allergy, unspecified, subsequent encounter.” Pet’rs’ Ex. 28, at 13–14. Dr. Siegel again

recommended following up with Dr. Shimamoto for advice on further vaccination, id., but no

later records were cited by the parties or the Special Master.

II. Proceedings Before the Special Master

On December 4, 2017, Petitioners, on behalf of R.F., filed a petition for compensation

under the National Childhood Vaccine Injury Act of 1986. 42 U.S.C. §§ 300aa-1 to -34. See

Pet., ECF No. 1. Petitioners claimed that R.F. had suffered an injury caused by the hepatitis B

vaccine he received on December 4, 2014. Pet’rs’ Mot. for Rev., at 1–2.

Over the next six years, Petitioners filed additional medical records, see ECF Nos. 8–11,

13–14, 16, 18, 28, 30, 60, 75, 79, and medical literature, see ECF No. 45. They also filed three

reports prepared by their expert, Dr. Ravi Durvasula. See ECF Nos. 41, 49, 67. The Secretary

filed his report under Vaccine Rule 4(c), see Resp’t’s Rep., ECF No. 24; see also RCFC App. B,

Vaccine Rule 4(c). The Secretary also submitted two reports prepared by the government’s

expert, Dr. Hayley Gans, see ECF Nos. 46, 71. Petitioners filed an amended petition on

September 5, 2018. Am. Pet., ECF No. 29.

On August 29, 2019, this case was reassigned to Special Master Daniel Horner. ECF No.

43. The parties jointly requested to forgo an entitlement hearing in favor of a ruling on the

record. See ECF No. 59; see also Pet’rs’ Mem. Supp. Pet., ECF No. 76; Resp’t’s Resp. to Pet’rs’

Mem. Supp. Pet., ECF No. 81; Pet’rs’ Reply Mem. Supp. Pet., ECF No. 81.

III. Decision of the Special Master

On August 12, 2024, Special Master Horner ruled that Petitioners were not entitled to an

award of compensation. Dec. at 1. He found that, even assuming R.F.’s first episode of altered

mental status and pallor was caused by the second dose of the hepatitis B vaccine he received,

that injury was not compensable as it did not persist for six months nor result in either death or

5

surgical intervention. Id. at 17 (citing 42 U.S.C. § 300aa-11(c)(1)(D)(i)). Therefore, the special

master explained, Petitioners’ entitlement to compensation was dependent upon whether they

could prove that the initial hypersensitivity reaction allegedly caused by the vaccine in turn

caused R.F. to develop chronic immune system dysregulation. Id.

In resolving that issue, the special master applied the three-prong test for establishing

causation set forth by the court of appeals in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d

1274 (Fed. Cir. 2005). Under that test, to show causation a petitioner must provide: (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 “temporal relationship between vaccination and injury.” 418 F.3d at 1278. The special

master held that Petitioners failed to satisfy any of the three prongs, and so failed to make a

prima facie case that the hepatitis B vaccine caused R.F.’s alleged injury. Dec. at 21, 27–28.

IV. Motion for Review

Petitioners filed their motion for review of the special master’s decision and a supporting

memorandum on September 11, 2024. See Pet’rs’ Mot. for Rev., ECF No. 85; Pet’rs’ Mem.

Supp. Mot. for Rev., ECF No. 88 [hereinafter Pet’rs’ Mem.]. They argue that the special master’s

findings on each of the three Althen prongs were not in accordance with law.

The Secretary filed a response on October 9, 2024. Resp’t’s Resp. to Pet’rs’ Mot. for

Rev., ECF No. 90. The Secretary contends that Petitioners have not identified any reversible

errors, that Petitioners are asking this Court to improperly reweigh the evidence in the record,

and that the special master’s decision was neither arbitrary and capricious, nor contrary to law.

Id.

With the Court’s leave, see ECF No. 93, Petitioners filed a reply brief on October 16,

2024. Pet’rs’ Reply Mem. Supp. Mot. for Rev., ECF No. 92. The Court has determined that oral

argument is unnecessary and that the case is ripe for disposition.

DISCUSSION

I. Jurisdiction

Congress established the National Vaccine Injury Compensation Program in 1986 to

provide a no-fault compensation system for vaccine-related injuries and deaths. Figueroa v.

Sec’y of Health & Hum. Servs., 715 F.3d 1314, 1316–17 (Fed. Cir. 2013). The Vaccine Act is

remedial legislation that “should be construed in a manner that effectuates its underlying spirit

and purpose.” Id. (quoting Cloer v. Sec’y of Health & Hum. Servs., 675 F.3d 1358, 1362 (Fed.

Cir. 2012) (en banc)).

A petition seeking compensation under the Vaccine Act is filed in the Court of Federal

Claims, after which the Clerk of the Court forwards it to the chief special master for assignment

to a special master. 42 U.S.C. § 300aa-11(a)(1). The special master to whom the petition is

assigned “issue[s] a decision on such petition with respect to whether compensation is to be

provided under the [Vaccine Act] and the amount of such compensation.” Id. § 300aa-

12(d)(3)(A).

6

The Vaccine Act grants the Court of Federal Claims jurisdiction to review the decisions

of special masters with authority to:

(A) uphold the findings of fact and conclusions of law of the special master and sustain

the special master’s decision,

(B) set aside any findings of fact or conclusion of law of the special master found to be

arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with

law and issue its own findings of fact and conclusions of law, or

(C) remand the petition to the special master for further action in accordance with the

court’s direction.

42 U.S.C. § 300aa-12(e)(2); see also Vaccine Rule 27.

II. Standard of Review

The Court reviews a special master’s legal determinations de novo, applying the “not in

accordance with law” standard. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321

(Fed. Cir. 2010); Althen, 418 F.3d at 1278–79. Judicial review of a special master’s factual

determinations, on the other hand, is circumscribed and “uniquely deferential.” Milik v. Sec’y of

Health & Hum. Servs., 822 F.3d 1367, 1376 (Fed. Cir. 2016) (quoting Hodges v. Sec’y of Health

& Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)). The court may only set aside a special

master’s factual determinations where they are arbitrary, capricious, and/or reflect an abuse of

discretion. Moberly, 592 F.3d at 1321.

In conducting judicial review, the court does not reweigh the evidence, examine its

probative value, or judge the credibility of the witnesses, for those “are all matters within the

purview of the fact finder.” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1254 (Fed.

Cir. 2011) (citing Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1349 (Fed.

Cir. 2010)). Thus, if a special master “‘has considered the relevant evidence of record, drawn

plausible inferences[,] and articulated a rational basis for the decision,’ then reversible error is

‘extremely difficult to demonstrate.’” Milik, 822 F.3d at 1376 (quoting Hines v. Sec’y of Health

& Hum. Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).

III. The Special Master’s Finding that Petitioners Failed to Satisfy Althen Prong One

To establish entitlement to compensation under the Vaccine Act, a petitioner must prove

by a preponderance of the evidence that the “illness, disability, injury, or condition” at issue was

caused—or significantly aggravated—by a vaccine. See 42 U.S.C. §§ 300aa-11(c)(1), -13(a)(1).

For an on-table claim, causation is presumed if the petitioner can show that (1) they received a

vaccination listed in the Vaccine Injury Table, 42 U.S.C. § 300aa-14, as revised by 42 C.F.R. §

100.3(a); and (2) they suffered the injury associated with that vaccine in the Table within the

period of time prescribed by the Table. See Andreu ex rel. Andreu v. Sec’y of Health & Hum.

Servs., 569 F.3d 1367, 1374 (Fed Cir. 2009) (citing 42 U.S.C. § 300aa-11(c)(1)(C)(i)).

7

There is no presumption of causation, however, for off-table claims like the one at issue

in this case. For those claims, a petitioner must establish causation in fact by proving by

preponderant evidence “that the vaccine was not only a but-for cause of the injury but also a

substantial factor in bringing about the injury.” Stone v. Sec’y of Health & Hum. Servs., 676

F.3d 1373, 1379 (Fed. Cir. 2012) (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d

1344, 1352–53 (Fed. Cir. 1999)). If a petitioner makes that showing, then the burden shifts to the

government to “show by a preponderance of the evidence that the injury [wa]s due to factors

unrelated to the vaccine.” Broekelschen, 618 F.3d at 1342 (citing Doe v. Sec’y of Health &

Hum. Servs., 601 F.3d 1349, 1351 (Fed. Cir. 2010)); see also 42 U.S.C. § 300aa-13(a)(1)(B).

As discussed above, in Althen, the court of appeals established a three-prong test

petitioners must satisfy to meet their burden of proving causation by preponderant evidence. For

the reasons set forth below, the Court concludes that the special master’s finding that Petitioners

failed to provide a sound and reliable medical theory causally connecting R.F.’s vaccination with

his injury, as required under Althen prong 1, was neither arbitrary and capricious nor contrary to

law. And, because failure to satisfy any one of the Althen prongs is fatal to a petitioner’s case,

the court finds it unnecessary to address Petitioners’ challenges to the special master’s finding

that they also failed to satisfy prongs two and three. See DePena v. Sec’y of Health & Hum.

Servs., 133 Fed. Cl. 535, 549 (2017), aff'd, 730 F. App’x 938 (Fed. Cir. 2018).

A. Petitioners’ Medical Theory

Althen prong one requires petitioners to supply “a medical theory causally connecting the

vaccination and the injury.” Althen, 418 F.3d at 1278. The theory need not be “medically or

scientifically certain,” but it must be “supported by sound and reliable medical or scientific

explanation.” Knudsen ex rel. Knudsen, 35 F.3d 543, 548–49 (Fed. Cir. 1994); see also Pafford

v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355–56 (Fed. Cir. 2006) (stating under prong

one “a petitioner must provide a reputable theory” that connects the vaccine to the injury).

Petitioners’ expert, Dr. Ravi Durvasula, reviewed R.F.’s medical records as well as

several published articles that he found pertinent, and articulated Petitioners’ theory of medical

causation. See Pet’rs’ Ex. 22, ECF No. 41-1; Pet’rs’ Ex. 30, ECF No. 67-1. 3 Dr. Durvasula

opined that after R.F. received his second dose of the hepatitis B vaccine, he experienced a

hypersensitivity reaction characterized by leukocytosis, hypothermia, and hypotonia. Pet’rs’ Ex.

22, at 4. Dr. Durvasula described R.F.’s reaction as “closely resembl[ing] a picture of septic

3

Dr. Durvasula is board certified in internal medicine and infectious diseases. Pet’rs’ Ex. 23, at

30, ECF No. 41-2. He completed a bachelor’s degree in biology and a medical degree from

McGill University a residency in internal medicine at Baylor College of Medicine, and a

fellowship at Yale University School of Medicine in infectious diseases. Id. at 1. Dr. Durvasula

is currently the Chairman of the Department of Medicine and the John W. Clark Endowed

Professor of Medicine in the Department of Public Health Sciences at Loyola University Stritch

School of Medicine. Id. at 1. He has published 75 peer-reviewed manuscripts and book chapters,

over 90 peer-reviewed abstracts and conference proceedings, and five books. Id. at 5–14.

8

shock,” and “a clear systemic inflammatory response to vaccination.” Id. He observed that

“[e]tiologies such as bacterial sepsis, seizures, or cardiovascular disease were excluded.” Id.

Therefore, Dr. Durvasula found the “most likely cause” of R.F.’s symptoms was “an exaggerated

immune response to the recombinant hepatitis B vaccine.” Id.

Dr. Durvasula observed that after this initial reaction, which he attributed to the vaccine,

R.F. continued to experience similar episodes several times per year. Id. These subsequent

episodes, he theorized, were “all presumably triggered by viral illnesses.” Id. Dr. Durvasula

acknowledged that there was “no specific diagnostic test” that could prove an association

between the vaccine, a hyperimmune reaction, and subsequent hyperimmune reactions to viral

illnesses, and that R.F. was experiencing a complication that was “very rare.” Id. Nonetheless, he

opined, “the link between the vaccine, subsequent viral challenges and a severely exaggerated

immune cascade resembling shock is plausible.” Id.

Dr. Durvasula explained that “the activation of the immune system, the very basis for the

use of vaccines, can become dysregulated.” Id. He stated that “several triggers—medications,

autoimmune signals and infectious pathogens—play etiologic roles.” Id. According to Dr.

Durvasula, “[c]ommon respiratory viruses that had little effect on [R.F.] prior to [his] hepatitis B

vaccination became triggers following [his] exposure.” Id. His “pattern of immune reactivity to

viral infections,” Dr. Durvasula further noted, was “predictable and consistent.” Id.

Dr. Durvasula stated that “such highly exaggerated responses have been reported in the

literature,” and that “abnormal profiles of immunity, though rare, are [also] described” in the

medical literature. Id. (citing L. Beretta et al., Churg-Strauss Vasculitis with Brain Involvement

Following Hepatitis B Vaccination, 19 Clinical & Experimental Rheumatology 757 (2001)

(Pet’rs’ Ex. 25, ECF No. 45-2); Nancy Agmon-Levin et al., Vaccines and Autoimmunity, 5

Nature Revs. Rheumatology 648 (2009) (Pet’rs’ Ex. 26, ECF No. 45-3)). He also took note of

Dr. Shahid’s October 2017 finding that R.F. had diffuse osteopenia. Id. at 5. According to Dr.

Durvasula, this finding provided a further reason to suspect immune dysregulation given R.F.’s

age and the association between chronic immunologic diseases and osteopenia, bone

abnormalities, and risk of fracture. Id.

Dr. Durvasula cited Dr. Oppenheimer’s report in support of his theory. Specifically, he

noted, Dr. Oppenheimer referred to R.F.’s initial episode as a “hyper-immune reaction, triggered

by the second dose of the hepatitis B vaccine.” Id. at 4 (quoting Pet’rs’ Ex. 2, at 2–3). Dr.

Oppenheimer also opined that the immune reaction “may speak to why three months later he had

another episode when questionably it was a viral related illness.” Id. (quoting Pet’rs’ Ex. 2, at 2–

3).

Dr. Durvasula also cited the observations of Dr. Siegel, R.F.’s treating physician. Id. Dr.

Siegel stated that R.F. had experienced an “immune hypersensitivity reaction by mechanism,”

and a “very rare immune reaction [that] seems to have been triggered by Hep B vaccine.” Id.

(quoting Pet’rs’ Ex. 6, at 32).

Based on the foregoing, Dr. Durvasula concluded that “vaccination with recombinant

antigens to confer immunity to hepatitis B is the likely cause of [R.F.’s] recurrent sepsis-like,

inflammatory response to viral infections.” Id. at 5. He characterized R.F.’s immune system as in

9

a state of “dysregulation.” Id. And, he opined, although “diagnostic testing for such a response is

not in the realm of standard clinical care,” that fact “should not detract from the plausibility of

this association.” Id.

B. The Government’s Response

Dr. Hayley Gans prepared an expert report for the government. Resp’t’s Ex. A, ECF No.

4

46-1. She concluded that Dr. Durvasula’s theory of causation lacked a reliable scientific basis.

Preliminarily, Dr. Gans observed that “no chronic conditions [have been] associated with

[the] Hepatitis B vaccine.” Id. at 5. She also noted that the evidence Dr. Durvasula cited to show

a relationship between the hepatitis B vaccine and R.F.’s initial episode was temporal and not

causal in nature. Id. Dr. Gans stated that the passage of time since the initial December 2014

episode made it less reasonable to assume that the vaccine caused the episode, because R.F.

continued to experience similar episodes that were triggered by other “inciting events.” Id. Dr.

Gans stated that “what is clear is that over time, as RF has experienced more episodes and more

evaluations have occurred, his treating physicians have begun to understand RF’s chronic

condition better.” Resp’t’s Ex. C, at 1, ECF No. 71-1. “Over time,” Dr. Gans observed, “the

allergy/immunology physician, using all of the clinical and laboratory information, concluded

that RF did not have anaphylaxis, [systemic inflammatory response syndrome (“SIRS”)] and

hyperimmune response;” “that the Hepatitis B vaccine that had initially been a consideration

given the temporal relationship to the first episode was not the ‘cause’ of the recurrent episodes;”

and “that these recurrent episodes would occur with many different triggers.” 5 Id.

Dr. Gans also disagreed with Dr. Durvasula’s characterization of R.F.’s episodes as

“sepsis-like” or as an episode of systemic inflammatory response syndrome (“SIRS”). She noted

that neither sepsis nor SIRS self-resolve in a few hours, as routinely occurred in R.F.’s case.

Resp’t’s Ex. A, at 5. And SIRS, she said, is not a recurrent condition. Id. Dr. Gans also

emphasized that “the onset of a chronic illness, even forms of immunodeficiency, are insidious

and develop over time with inciting events before their onset and a different reaction once the

condition manifests.” Id. As such, Dr. Gans emphasized that the immunologists who saw R.F. in

4

Dr. Gans received a bachelor’s degree in biochemistry from Connecticut College and her

medical degree from SUNY Health Science Center at Syracuse. Resp’t’s Ex. B, at 1, ECF No.

46-8. She completed an internship and residency program in the Department of Pediatrics and a

fellowship in the Division of Pediatric Infectious Diseases at Stanford University School of

Medicine. Id. Dr. Gans currently works as a clinical professor and Director of Fellowship

Education in the Department of Pediatrics, and the Fellowship Associate Program Director of

Pediatrics Infectious Diseases at Stanford University Medical Center. Id. Dr. Gans has published

30 peer-reviewed articles, nine book chapters, and 34 abstracts. Id. at 5–10.

5

The “allergy/immunology physician” to whom Dr. Gans referred appears to be Dr.

Tongchinsub. See Resp’t’s Ex. C, at 1 (citing Pet’rs’ Ex. 21, at 1–3). As described above, she

opined that it was “unlikely” that R.F.’s constellation of symptoms was caused by a vaccine,

because his subsequent episodes recurred without the incitement of a vaccine. Pet’rs’ Ex. 21, at

3.

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2017 and 2018 were better able to understand R.F.’s chronic condition than Dr. Oppenheimer,

who saw R.F. in 2014. Id.

Dr. Gans further asserted that Dr. Durvasula’s report was flawed in that it provided “no

biologic plausible explanation” to explain “how a hyper immune response to [a] Hepatitis B

vaccine would cause a hyperimmune response to subsequent unrelated infectious exposures.” Id.

In addition, she criticized Dr. Durvasula’s reliance on publications that were inapposite because

they involved different conditions, and the reactions described in the literature did not fit R.F.’s

history. See id. at 5–6.

Dr. Gans concluded that “[R.F.’s] episodes are a result of a predisposing condition and

are not dependent on any specific inciting event, as is the rule with chronic conditions.” Id. at 6.

Further, she said, “[t]here is no biologic plausibility to one specific insult causing a condition

that recurs upon exposure to unrelated insults, and no data to support the receipt of a vaccine

with a chronic recurring condition.” Id. at 6.

Dr. Gans also questioned whether R.F.’s episodes were actually associated with his viral

illnesses. See Resp’t’s Ex. C, at 2. She opined that “RF has an underlying condition, the cause of

which is likely genetic, with manifestations after variable triggers.” Id. at 3. She stated further

that “[t]hese triggers do cause the clinical signs and symptoms but do not cause the underlying

condition.” Id. In short, she explained, while the vaccine “was only temporally associated with

one of many events,” “the cause of RF’s recurring episodes can be explained entirely by an

underlying condition which is entirely independent of the vaccine.” Id. at 3–4.

C. The Special Master’s Opinion

The special master conducted a detailed review of R.F.’s medical records and a

comprehensive analysis of the expert reports and the medical literature, which he discussed at

length in his opinion. See Dec. at 17–21. He concluded, in agreement with Dr. Gans, that

Petitioners failed to present sufficient evidence in support of their theory that the hepatitis B

vaccine “can cause a hypersensitivity reaction that would in turn cause chronic immune

dysregulation resulting in episodic presentations of hypothermia, unresponsiveness, and

hypotonia, coupled with diffuse osteopenia.” Id. at 21. He therefore found that Petitioners had

failed to meet their burden of supplying a medical theory of causation that is “supported by

sound and reliable medical or scientific explanation.” See Knudsen ex rel. Knudsen, 35 F.3d at

548.

As the special master observed, Dr. Durvasula characterized R.F.’s initial reaction to the

hepatitis B vaccine as a hypersensitivity response. Dec. at 17–18. He noted that Dr. Durvasula

had opined that the response caused R.F. to suffer similar subsequent episodes that, unlike his

initial reaction, were triggered by viral illnesses. Id. (citing Pet’rs’ Ex. 22, at 4). The special

master found this theory was not supported by a sound and reliable scientific explanation. He

noted Dr. Gans’s observations that “hypersensitivity reactions and SIRS are acute responses that

do not present chronically and/or episodically” and that “hypersensitivity responses are antigen-

specific.” Dec. at 18 (citing Resp’t’s Ex. C, at 2–3). “[H]ypersensitivity alone [did] not explain

R.F.’s episodic presentation,” the special master reasoned, “given that the later episodes were

triggered by other unspecified viral illnesses.” Id. Quoting Dr. Gans, the special master observed

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that “there is no biologic condition where one trigger, e.g. a vaccine, causes a ‘normal’ response

to suddenly chronically dysregulate so that all subsequent unrelated exposures cause the same

dysregulation.” Id. (quoting Resp’t’s Ex. C, at 2). In the special master’s view, Dr. Durvasula

“glosse[d] over the details of the proposed relationship between hypersensitivity and

autoimmunity” and did not fully “articulate[] how R.F.’s alleged post-vaccination

hypersensitivity reaction could have led to the chronic state of immune dysregulation he posits.”

Id.

Further, Dr. Durvasula had relied on the Agmon-Levin article for the proposition that

“autoimmunity can arise in susceptible individuals as a result of environmental triggers,

including from vaccine antigens.” Id. (referring to Pet’rs’ Ex. 26). But the article did not

specifically discuss the hepatitis B vaccine nor any condition that matched R.F.’s symptoms. See

Pet’rs’ Ex. 26. Moreover, the Special Master observed, even accepting Dr. Durvasula’s theory

that a vaccine could result in hypersensitivity leading to autoimmunity, Dr. Durvasula’s ultimate

reliance on autoimmunity in this case “would still be unsupported ipse dixit that cannot be

credited.” Dec. at 19. The special master acknowledged that “[t]here is no question that

autoimmunity is an established category of disease that can, in at least some instances, be linked

to vaccination.” Id. (citing 42 C.F.R. § 100.3(b)(15)). “However,” the special master noted,

“there are various pathways to autoimmunity and many autoimmune conditions have little to no

suspicion of vaccine causation.” Id. “Despite invoking the concept as the sole explanation for the

chronic immune dysregulation he posits,” the special master found, “Dr. Durvasula has not

substantiated that autoimmunity is relevant to this case and has not sufficiently articulated a

theory based in autoimmunity.” Id.

The special master also found Dr. Durvasula’s theory unsupported because he did not

identify which type of hypersensitivity R.F. experienced, id. at 18 (citing Pet’rs’ Ex. 30, at 4),

nor which autoimmune disorder R.F. suffers from or even might suffer from, id. at 19

(“[M]edical recognition of the injury claimed is critical and by definition a ‘vaccine-related

injury,’ . . . has to be more than just a symptom or manifestation of an unknown injury.” (quoting

Broekelschen, 618 F.3d at 1349)).

The special master acknowledged that Dr. Durvasula had referenced the possibility that

“hypersensitivity can result in cross reaction and molecular mimicry, which is a known

mechanism of autoimmunity.” Dec. at 20. He also acknowledged that “[m]olecular mimicry ‘is a

generally accepted scientific principle,’” but noted that its “mere invocation” was not sufficient

to carry Petitioners’ burden to show causation. Id. (quoting Deshler v. Sec’y of Health & Hum.

Servs., 2020 WL 4593162, 2020 U.S. Claims LEXIS 1418 (Fed. Cl. July 1, 2020)). Further, the

special master observed that Dr. Durvasula “[did] not identify any proposed homology, any

relevant autoantibody, or even explain what specific autoimmune target within the body would

be responsible for [R.F.’s symptoms].” Id. In short, the Special Master found Dr. Durvasula’s

analysis was “too vague to preponderantly support a theory of causation.” Id.

D. Petitioners’ Prong One Arguments

As the foregoing shows, the special master discussed the evidence at length, explaining

why he gave greater weight to the opinions of the government’s expert, Dr. Gans, than to those

of Petitioners’ expert, Dr. Durvasula. See Dec. at 17–21. He concluded that there was a “dearth”

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of evidence or explanation supporting Dr. Durvasula’s opinion that hepatitis B vaccine could

cause a hypersensitivity reaction that would result in chronic immune system dysregulation

leading to episodes of hypothermia, unresponsiveness, and hypotonia. Id. at 21. And for that

reason, he found that Petitioners had not met their burden as to general causation under Althen

prong 1.

In their motion for review, Petitioners cast these determinations as legally erroneous.

However, Petitioners’ objections are not grounded in the law; they are grounded in a

disagreement about the weight the special master assigned to the evidence upon which the

parties relied. See Pet’rs’ Mem. at 34–39. Their objections are therefore subject to the “uniquely

deferential” standard of review applicable to a special masters’ findings of fact.

Petitioners have not shown that the special master’s determination that they failed to

satisfy prong one was arbitrary and capricious or an abuse of discretion. In fact, the section of

their brief that addresses prong one consists largely of lengthy block quotes from Dr.

Durvasula’s expert reports. Id. at 37–38. Petitioners also reference and quote at length a passage

from the court’s decision in Caves v. Sec’y of Health & Hum. Servs., which held that

petitioners must supply something more than a “plausible” theory to meet their burden of proof

under Althen prong one. Id. at 35–36 (quoting 100 Fed. Cl. 119, 143 (2011), aff’d sub nom.,

463 F. App’x 932 (Fed. Cir. 2012)).

As best the Court can follow their argument, it appears that Petitioners’ main critique of

the special master’s ruling on prong one concerns the impact that the absence of a definitive

diagnosis had on his reasoning. Petitioners imply that, in finding that they lacked a reliable

theory of causation, the special master improperly depended upon the fact that R.F. was

diagnosed with an “unspecified” disorder of the immune system. See id. at 39.

As Petitioners note, the special master commented that because a specific autoimmune

disorder had not been identified it would be “speculative” to determine that the cause of the

disorder was R.F.’s reaction to the vaccine, as opposed to a condition that pre-existed his receipt

of the vaccine. Dec. at 26. But this was by no means the sole or even principal reason the

special master found that Petitioners failed to satisfy prong 1.

To the contrary, as described above, the special master found Dr. Durvasula’s theory

unsupported because he had “glosse[d] over the details of the proposed relationship between

hypersensitivity and autoimmunity.” Id. at 18. In addition, Dr. Durvasula did not “clarify what

type of hypersensitivity he [invoked].” Id. (citing Pet’rs’ Ex. 30). Further, Dr. Durvasula relied

on medical literature to support his claim that hypersensitivity can lead to autoimmunity, but

that literature did not discuss the hepatitis B vaccine nor any autoimmune condition similar to

R.F.’s. Id.; see also Pet’rs’ Ex. 30 (quoting Pet’rs’ Ex. 26). And Dr. Durvasula did not

“identif[y] any autoimmune pathway [that] could theoretically result in [R.F.’s symptoms].”

Dec. at 19.

In addition, the special master based his determination on Dr. Gans’s observations that

hypersensitivity responses are antigen-specific, that “there is no biologic condition where one

trigger, e.g. a vaccine, causes a ‘normal’ response to suddenly chronically dysregulate so that all

subsequent unrelated exposures cause the same dysregulation,” and that “hypersensitivity

13

reactions and SIRS are acute responses that do not present chronically and/or episodically.” Dec.

at 18 (quoting Resp’t’s Ex. C, at 2–3). The special master found that all of these observations

undermined Petitioners’ arguments.

As the court of appeals has observed, in vaccine cases “[t]he special master's decision

often times is based on the credibility of the experts and the relative persuasiveness of their

competing theories.” Broekelschen, 618 F.3d at 1347 (citing Lampe v. Sec’y of Health & Hum.

Servs., 219 F.3d 1357, 1362 (Fed. Cir. 2000)). In such cases, “[t]he statute makes clear that, on

review, the Court of Federal Claims is not to second guess the Special Masters fact-intensive

conclusions.” Milik, 822 F.3d at 1376 (quoting Hodges, 9 F.3d at 961). Petitioners have not

persuaded the Court that the special master abused his discretion in crediting the opinions of the

government’s expert over those of their own. And because they have failed to satisfy Althen

prong one, their motion for review must be denied.

CONCLUSION

For the foregoing reasons, the special master’s determination that Petitioners failed to

satisfy Althen prong one was neither arbitrary and capricious, nor contrary to law. Petitioners’

motion for review is therefore DENIED and the decision of the special master is SUSTAINED.

The Clerk is directed to enter judgment accordingly.

IT IS SO ORDERED.

s/ Elaine D. Kaplan

ELAINE D. KAPLAN

Chief Judge

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