FIORELLO v. SECRETARY OF HEALTH AND HUMAN SERVICES

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 17-1869V

Filed: August 12, 2024

STEPHANE FIORELLO and

ANTHONY FIORELLO, on behalf of

their minor child, R.F.,

Petitioner,

v.

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

Andrew Donald Downing, Downing, Allison, & Jorgenson, Phoenix, AZ, for petitioner

Ryan Pohlman Miller, U.S. Department of Justice, Washington, DC, for respondent

Decision1

On December 4, 2017, petitioners filed a petition under the National Childhood

Vaccine Injury Act, 42 U.S.C. § 300aa-10, et seq. (2012),2 alleging that a hepatitis B

vaccination that their minor child, R.F., received on December 4, 2014, caused him to

develop systemic inflammatory response syndrome (“SIRS”). (ECF No. 1; ECF No. 29,

¶¶ 32-33.) For the reasons set forth below, I conclude that petitioners are not entitled to

an award of compensation.

I. Applicable Statutory Scheme

Under the National Vaccine Injury Compensation Program, compensation

awards are made to individuals who have suffered injuries after receiving vaccines. In

1 Because this document contains a reasoned explanation for the action taken in this case, it must be

made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or

at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government

Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic

Government Services). This means the document will be available to anyone with access to the

internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact

medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.

If, upon review, I agree that the identified material fits within this definition, I will redact such material from

public access.

2 Within this decision, all citation to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C. §

300aa-10-34.

1

general, to gain an award, a petitioner must make a number of factual demonstrations,

including showing that an individual received a vaccination covered by the statute;

received it in the United States; suffered a serious, long-standing injury; and has

received no previous award or settlement on account of the injury. Finally – and the key

question in most cases under the Program – the petitioner must also establish a causal

link between the vaccination and the injury. § 300aa-11(c).

In some cases, the petitioner may simply demonstrate the occurrence of what

has been called a “Table Injury.” That is, it may be shown that the vaccine recipient

suffered an injury of the type enumerated in the “Vaccine Injury Table,” corresponding to

the vaccination in question, within an applicable time period following the vaccination

also specified in the Table. If so, the Table Injury is presumed to have been caused by

the vaccination, and the petitioner is automatically entitled to compensation, unless it is

affirmatively shown that the injury was caused by some factor other than the

vaccination. § 300aa-13(a)(1)(A)-(B); § 300aa-11(c)(1)(C)(i); § 300aa-14(a). In this

case, petitioners’ allegations do not implicate any Table Injury.

When the vaccine recipient suffered an injury not of the type covered in the

Vaccine Injury Table, an alternative means exists to demonstrate entitlement to a

Program award. That is, the petitioner may gain an award by showing that the

recipient’s injury was “caused-in-fact” by the vaccination in question.

§ 300aa-13(a)(1)(A); § 300aa-11(c)(1)(C)(ii). In such a situation, of course, the

presumptions available under the Vaccine Injury Table are inoperative. The burden is

on the petitioner to introduce evidence demonstrating that the vaccination actually

caused the injury in question. Althen v. Sec’y of Health & Human Servs., 418 F.3d

1274, 1278 (Fed. Cir. 2005); Hines ex rel. Sevier v. Sec’y of Health & Human Servs.,

940 F.2d 1518, 1525 (Fed. Cir. 1991). In this case, petitioners must meet this burden of

proof for establishing causation-in-fact.

The showing of “causation-in-fact” must satisfy the “preponderance of the

evidence” standard, the same standard ordinarily used in tort litigation.

§ 300aa-13(a)(1)(A); see also Althen, 418 F.3d at 1279-80; Hines, 940 F.2d at 1525.

Under that standard, the petitioners must show that it is “more probable than not” that

the vaccination was the cause of the injury. Althen, 418 F.3d at 1279. The petitioners

need not show that the vaccination was the sole cause but must demonstrate that the

vaccination was at least a “substantial factor” in causing the condition and was a “but

for” cause. Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir.

1999). Thus, the petitioners must supply “proof of a logical sequence of cause and

effect showing that the vaccination was the reason for the injury[,]” with the logical

sequence being supported by “reputable medical or scientific explanation, i.e., evidence

in the form of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278;

see also Grant ex rel. Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148

(Fed. Cir. 1992). A petitioner may not receive a Vaccine Program award based solely

on his or her assertions; rather, the petition must be supported by either medical

records or by the opinion of a competent physician. § 300aa-13(a)(1).

2

In what has become the predominant framing of this burden of proof, the Althen

court described the “causation-in-fact” standard, as follows:

Concisely stated, Althen’s burden is to show by preponderant evidence that

the vaccination brought about her injury by providing: (1) a medical theory

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

of cause and effect showing that the vaccination was the reason for the

injury; and (3) a showing of proximate temporal relationship between

vaccination and injury. If Althen satisfies this burden, she is “entitled to

recover unless the [government] shows, also by a preponderance of the

evidence, that the injury was in fact caused by factors unrelated to the

vaccine.”

Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner

need not necessarily supply evidence from medical literature supporting a causation

contention, so long as the petitioner supplies the medical opinion of an expert. Id. at

1279-80. The court also indicated that, in finding causation, a Program fact-finder may

rely upon “circumstantial evidence,” which the court found to be consistent with the

“system created by Congress, in which close calls regarding causation are resolved in

favor of injured claimants.” Id. at 1280.

II. Procedural History

This case was initially assigned to another special master. (ECF No. 4.) It was

reassigned to the undersigned on August 29, 2019. (ECF No. 43.)

Because this case was filed close to the expiration of the statute of limitations,

the allegations of the initial petition were limited to contending that R.F. had suffered a

severe adverse reaction to his vaccination. (ECF No. 1.) Petitioners filed a statement

by Ms. Fiorello (Ex. 1) and medical records (Exs. 2-17) between December of 2017 and

April of 2018. (ECF Nos. 8-11, 13-14, 16, 18.)

Respondent filed his Rule 4 Report on August 6, 2018. (ECF No. 24.)

Respondent contended that the medical records did not satisfy petitioner’s burden of

proof with respect to proving that R.F. suffered a severe adverse reaction to his

vaccination. (Id. at 12.) Petitioners subsequently filed R.F.’s school records (Exs. 19-

20), additional medical records (Ex. 21), and an amended petition more specifically

alleging that R.F. suffered SIRS. (ECF No. 28; ECF No. 29, ¶¶ 32-33; ECF No. 30.)

On August 27, 2019, petitioners filed an expert report by internist and infectious

disease specialist Ravi Durvasula, M.D. (ECF No. 41; Exs. 22-23; see also ECF No.

45; Exhibits 24-26 (supporting literature).) Respondent filed a responsive expert report

by pediatrician and infectious disease specialist Hayley Gans, M.D., on December 20,

2019. (ECF No. 46; Exs. A-B.) Petitioners then filed a further report by Dr. Durvasula in

March of 2020. (ECF No. 49; Ex. 27.)

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Thereafter, an entitlement hearing was set to be held in December of 2021.

(ECF No. 54-55.) However, in the process of preparing for the hearing, the parties

determined that they preferred to resolve the case on the written record. (ECF No. 59.)

During a status conference held October 28, 2021, I advised the parties that I was

amenable to resolving the case on the written record, but that I required further

clarification from the experts regarding the nature of the conditions at issue, specifically

hypersensitivities, SIRS, and chronic immune dysregulation. (Id. at 1-2.)

Petitioners then filed updated medical records (Exs. 28-29) in December of 2021

and a supplemental report by Dr. Durvasula (Ex. 30) in July of 2022. (ECF Nos. 60,

67.) Respondent filed a supplemental report by Dr. Gans in January of 2023. (ECF No.

71; Ex. C.)

Petitioners filed their brief regarding entitlement and further updated medical

records on April 11, 2023. (ECF Nos 75-76; Ex. 31.) R.F.’s updated medical records

revealed that he had undergone genetic testing and respondent requested an

opportunity to review those results. (ECF No. 78.) Petitioner filed a final set of medical

records on July 17, 2023. (ECF No. 79; Ex. 32.) Respondent filed his response to

petitioners’ brief regarding entitlement on August 8, 2023. (ECF No. 81.) Petitioners

filed their reply brief on August 21, 2023. (ECF No. 82.)

This matter is now ripe for resolution. I have concluded that the parties have had

a full and fair opportunity to develop the record and that it is appropriate to resolve this

case without an entitlement hearing. See Kreizenbeck ex rel. C.J.K. v. Sec’y of Health

& Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (citing Simanski v. Sec’y of

Health & Human Servs., 671 F.3d 1368, 1385 (Fed. Cir. 2012)); see also Vaccine Rule

8(d); Vaccine Rule 3(b)(2).

III. Factual History

a. Medical Records

R.F. is a triplet, who was born prematurely by cesarian section at 29 weeks of

gestation. (Ex. 14, pp. 13-14.) His Apgar scores were eight at one minute and eight at

five minutes. (Id. at 13.) While in the NICU, he was treated for respiratory distress

syndrome, hyperbilirubinemia, choroid plexus cyst, retinopathy of prematurity, apnea,

tachycardia, and feeding difficulties. (Id.)

At his 12-month well visit, mild to moderate speech delay and feeding difficulties

were noted. (Ex. 17, pp. 7-9.) By his two-year well visit, he was receiving regular

speech therapy and received a recommendation for occupational therapy to assist with

sensory integration difficulties. (Id. at 13-15.) By the time of his three-year well visit,

R.F. displayed delays in his gross motor skills and was referred to physical therapy. (Id.

at 22-24.) At his five-year well visit, a neurodevelopmental evaluation was

recommended due to his sensory issues, behavioral problems, fine and gross motor

issues, and speech delays. (Ex. 5, pp. 6-10.) Following that evaluation, R.F. was

4

diagnosed with fine and gross motor delays, a sensory processing disorder, Attention

Deficit Hyperactivity Disorder (“ADHD”), constipation, and mild anxiety. (Ex. 17, pp. 52-

57.)

On August 28, 2014, R.F. received his first hepatitis B vaccination. (Ex. 5, p. 11.)

He returned for his second hepatitis B vaccination, which is the subject of this petition,

on December 4, 2014. (Id. at 14.) The second hepatitis B dose was delayed because

R.F. had an upper respiratory infection in October of 2014. (Id. at 12-13; Ex. 1, ¶ 17.)

Prior to administration of the December 4, 2014 hepatitis B vaccine, R.F.’s medical

records express no concern regarding any immunologic condition or abnormality.

Petitioners’ brief discusses petitioners’ observation that R.F.’s two triplet sisters faced

greater struggles with common childhood illnesses than did R.F. (ECF No. 76, pp. 2-4.)

However, this was a comparative observation with no indication that either R.F.’s or his

sisters’ immune responses were abnormal. Petitioners’ brief also discusses an unusual

sudden onset of colorblindness occurring in the autumn of 2014, as well as eye pain

and other issues with R.F.’s vision. (Id. at 4-17.) While there are some references in

the later medical records questioning whether R.F.’s eye problems were related to his

hepatitis B vaccine (see Ex. 15, p. 1; Ex. 4, pp. 4-9; Ex. 28, p. 30), petitioners have not

argued that this is a part of R.F.’s alleged vaccine injury. R.F. was eventually tested for

optic neuritis, but the etiology of his vision complaints remained “unclear.” (Ex. 15, pp.

1-3.) The course of R.F.’s medical encounters for his vision problems are not

summarized. R.F. also suffered a fracture of his right wrist on November 19, 2014. (Ex.

10, pp. 2-5.) The follow up encounters for that fracture are also not summarized.

The day after vaccination, on December 5, 2014, R.F. presented to urgent care

with pallor and an altered mental state (“intermittently becomes obtunded[3]”), though he

was noted to be oriented to time, place, and person. (Ex. 3, pp. 2-3.) The onset was

acute and occurred after he had been picked up from school. (Id. at 2.) There was no

history of trauma or ingestion and no fever, vomiting, or headache. (Id.) Petitioners

reported a family history of “severe vaccine reactions” and that R.F.’s grandfather had

recently been hospitalized with a staph infection. (Id. at 3.) It was also later reported

that R.F. had been treated for an upper respiratory infection with a full course of

antibiotics just a week early. (Ex. 11, p. 4.) Petitioners also reported R.F.’s “recent

cough and [upper respiratory infection symptoms],” to R.F.’s emergency room

physicians. (Ex. 5, p. 23.) However, no additional medical records have been filed that

reflect this presentation and treatment. Physical exam was otherwise normal.4 (Ex. 3,

p. 2.) Bloodwork revealed elevated ALP, AST, glucose, and white blood cell count, as

3 “Obtund” refers to a reduced level of sensation or alertness.

Obtund, DOLAND’S MEDICAL DICTIONARY

ONLINE, https://www.dorlandsonline.com/dorland/definition?id=34619&searchterm=obtund (last visited

July 15, 2024).

4 In her statement, Ms. Fiorello indicates that R.F.’s temperature was taken repeatedly and confirmed

hypothermia measured at 94⁰F. (Ex. 1, ¶ 21.) However, this is not reflected in the medical record. R.F.’s

initial vitals included a temperature of 96.7⁰F and hypothermia is not noted. (Ex. 3, p. 2.) During

subsequent transport to the hospital, R.F. was observed to be “warm, dry, pale in color.” (Ex. 11, p. 4.)

5

well as low creatinine. (Id. at 3-4.) R.F. was placed on a saline IV and was transferred

via EMS to a pediatric emergency department. (Id. at 4; see also Ex. 11, pp. 2-6.)

Upon arrival at the emergency department, R.F. was seen immediately due to a

high probability of life threatening deterioration. (Ex. 11, p. 12.) He was placed on a

cardiac monitor and an ECG was obtained. (Id.) IV fluids were administered, and

additional lab work was ordered, which showed some improvement in leukocytosis.

(Id.) Pediatric neurology was consulted. (Id.) There was low suspicion for seizures, but

an EEG and further neurology follow up was recommended. (Id.) The initial impression

was “unresponsive episode” with a differential diagnosis including syncope, seizure, or

intercurrent illness. (Id.) R.F. was discharged home the same day. (Id.)

About three months later, on March 6, 2015, R.F. was seen by his pediatrician for

symptoms of an upper respiratory infection. (Ex. 5, pp. 17-19.) It was reported that

R.F. had experienced an episode wherein he “turned pale yesterday & skin was cold.

Mom thought he was going to faint.” (Id. at 17.) He experienced a hypotonic episode of

about 30 minutes with no loss of consciousness, after which he was lethargic and

drowsy. (Id.) He was back to normal after about three hours. (Id.) It was further

reported that R.F. had a “similar episode 6 weeks ago after Hep B vac. [S]aw neuro

who thought it was from the vac. [N]euro report not in EMR.”5 (Id.) Physical exam was

normal except for nasal congestion. (Id.) R.F. was diagnosed with an unspecified

upper respiratory infection and a “hypotonic/hyporesponsive episode.” (Id. at 18.)

Further follow up was recommended to rule out any seizure disorder or other neurologic

problem. (Id.) An EEG was subsequently performed on March 27, 2015, and was

overall normal. (Ex. 9, p. 95.) That record indicates that, in addition to two episodes of

near passing out, R.F. also had a history of migraines. (Id.)

R.F. had his annual exam on March 25, 2015, at which time additional

immunizations, including a further dose of hepatitis B, was recommended.6 (Ex. 5, pp.

20-22.) R.F. was then evaluated by an allergy and immunology specialist, John J.

Oppenheimer, M.D. on April 2, 2015, because “[t]here is concern with regard to next

vaccination and direction is needed.” (Ex. 2, p. 2.) The assessment was as follows:

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

5 Although the emergency department record notes that neurology was consulted, I have not located any

separate neurology consultation record. The emergency department record is limited to noting that the

neurologist “did not feel his symptoms or the story was consistent with a seizure.” (Ex. 11, p. 12.) In her

statement, Ms. Fiorello indicates that the emergency department physician expressed of R.F.’s

presentation that “it did appear this may be vaccine related in reviewing the events of the last 24 hours

and the vaccine was the only thing out of the ordinary.” (Ex. 1, ¶ 24.) However, she appears to indicate

that her discussion with the neurologist was focused instead on a possible optic neuritis (Id. at ¶ 25),

which was subsequently not indicated (Ex. 15, pp. 1-3).

6 He also presented with ear pain. (Ex. 5, p. 20.)

6

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. at 3.)

On May 18, 2015, R.F. presented to another medical center for “other

convulsions.” (Ex. 9, p. 7.) The assessment indicated that R.F. was presenting with

“episodes concerning for seizures” with pallor and limpness.7 (Id. at 15.) In addition to

the two episodes discussed above, the provided history also includes a discussion of

episodes of “eye buggies” primarily in the right eye that last for a few seconds and are

associated with watery eyes. (Id. at 12.) The records are inconsistent regarding the

onset of the “eye buggies,” with one history placing onset in March of 2015 (Id.) and

another placing onset in August of 2014 (Id. at 16). In her statement, Ms. Fiorello

explains: “over the first month of school, [R.F.] began complaining of ‘eye bogies’ where

his eyes would suddenly tear and he would run from the room. He explained the light

was hurting his eyes and making him cry.” (Ex. 1, ¶ 15.) From May 18, 2015 to May

20, 2015, R.F. was hospitalized and underwent a 48-hour video EEG observing him

while both awake and asleep. (Ex. 9, pp. 31-32.) During this period, he experienced

multiple episodes of “bugs in the eyes” and no EEG changes were seen. (Id. at 31.)

The EEG was interpreted as normal and the observed episodes deemed nonepileptic.

(Id. at 31-32.)

R.F. presented with a cough and fever on May 25, 2017. (Ex. 28, pp. 28-31.) It

was reported that R.F. “goes into shock with every new virus, one episode on

Saturday.” (Id. at 28.) These episodes were classified as “immune episodes,” and it

was noted that these episodes “[s]eem[ed] to have started after starting Hep B series.”

(Id. at 29-30.) R.F. was assessed with a fever, with no signs of a bacterial infection, and

“hypotensive episode[s]” with “unclear etiology.” (Id. at 31.) On July 19, 2017, R.F.

established care with Jeffery Siegel, M.D. (Ex. 6, p. 31.) Dr. Siegel explained that he

had reviewed R.F.’s medical records and that R.F. suffered reactions to viral infections

that started after he received both hepatitis B vaccines. (Id. at 31-32.) Dr. Siegel

reported that R.F.’s episodes involved “pallor, hypotension, decreased mental status.”

(Id. at 31.) Dr. Siegel reported that R.F. had been evaluated by an immunologist who

reported that R.F.’s condition was not an allergic or anaphylactic reaction, but is,

instead, an immune reaction. (Id. at 32.) Dr. Siegel assessed petitioner with an

“[i]mmune hypersensitivity reaction by mechanism.” (Id.)

7 The records from this medical center indicate that R.F.’s episodes included a loss of consciousness (Ex.

9, p. 31) whereas the prior records indicated altered mental status without indicating a loss of

consciousness (Ex. 3, pp. 2-3 (obtunded but oriented to time, place, and person) and Ex. 5, p. 17

(specifying no loss of consciousness)).

7

On August 17, 2017, R.F. was evaluated by S. Reed Shimamoto, M.D. for

“immune deficiency.” (Ex. 4, p. 4.) Dr. Shimamoto reported that R.F. was born 29

weeks premature and had an “prolonged NICU stay.” (Id.) He explained that after R.F.

received his first hepatitis B vaccine, “he went color blind had seen ophthalmology for

eye disease.” (Id.) Dr. Shimamoto then reported that, 23 hours after R.F.’s second Hep

B vaccine, “he had symptoms of septic shock” and a decrease in his white blood cell

count. (Id.) Dr. Shimamoto explained that R.F. has continued to suffer from these

episodes following viral infections. (Id. at 4-5.) He describes R.F.’s episodes as “one

quick cough, like a cat clearing its throat and then within 60 seconds he has complete

pallor, non-responsive, floppy, [and] his body temperature drops to 96 [degrees].” (Id. at

5.) Dr. Shimamoto expresses “concern about possible relationship to vaccinations and

these episodes,” however, he was unable to offer a definitive diagnosis. (Id. at 6.) He

then ordered “an immune screen” and recommended reviewing R.F.’s “vaccine

responses from his infant series to see if there is a pattern of specific immune related

disease.” (Id.) R.F. broke his arm again in October of 2017 and was subsequently

diagnosed with osteopenia. (See Ex. 7, pp. 23-26; Ex. 29, pp. 48-53.)

On April 27, 2018, R.F. saw Michael Daines, M.D., and allergy and immunology

fellow Pamela Tongchinsub, M.D., for an “evaluation of suspected vaccination reaction,

after developing fever, leukocytosis, and a range of episodic sins and symptoms

including gagging reflux, cough, body temperature drops, turns pale, lips turn white,

tachycardic.” (Ex. 21, p. 3.) Dr. Tongchinsub noted “these symptoms appear without

occurrence of vaccines as well.” (Id.) She reported that R.F.’s differential diagnosis

included POTS, mastcell, congenital heart disease, and idiopathic anaphylaxis. (Id.)

She explains that R.F.’s condition was unlikely “immunodeficiency or vaccine reaction.”

(Id.) Mast cell was eventually ruled out in August of 2018. (Id. at 12.)

R.F. underwent genetic testing on April 12, 2021, which was normal. (Ex. 32, pp.

35-67.) R.F. was evaluated by cardiologist Theresa Grebe, M.D., on April 21, 2021.

(Id. at 20-23.) After summarizing R.F.’s symptoms and completing an exam, Dr. Grebe

reported that she “can not think of any clear unifying etiology that would explain [R.F.’s]

symptoms,” and she explained that she did not think any cardiology follow up was

necessary. (Id. at 22.) R.F. had a wellness check on August 18, 2021 with Dr. Siegel.

(Ex. 31, p. 10-13.) He was assessed with “immune hypersensitivity reaction by

mechanism,” under which Dr. Siegel reported that his work up remained negative. (Id.

at 13.)

b. Declaration

Petitioner, Stephane Fiorello, filed a statement in this case. (Ex. 1.) Petitioner

explained that her son R.F. is a triplet and was born premature on December 8, 2008.

(Id. at ¶ 3.) R.F. was transferred to the NICU and his “course was unremarkable

beyond the common issues of prematurity, which included retinopathy of prematurity,

respiratory distress syndrome, apnea, tachycardia, and feeding difficulties.” (Id. at ¶ 4.)

R.F. was also diagnosed “with an uncomplicated, unsealed gluteal cleft and a choroid

plexus cyst that resolved shortly after birth.” (Id.)

8

While in the NICU, R.F. received the RSV vaccine. (Ex. 1, ¶ 5.) The rest of

R.F.’s vaccinations were initially postponed until his expected due date in February of

2009, where thereafter, R.F. began the typical vaccine schedule for newborns, except

petitioner declined hepatitis vaccines. (Id.) In mid-January, R.F. transitioned out of the

NICU and was able to go home. (Id. at ¶ 6.) However, he continued to be monitored by

the NICU and he experienced “gross motor delays, speech delays, and sensory

processing issues,” which, petitioner testified, was “typical of prematurely born children.”

(Id. at ¶ 7.) R.F. made improvements in these areas and “was a very happy, very

affectionate child,” however, he did experience stress and anxiety when leaving the

house. (Id. at ¶ 8.) Petitioner also testified that R.F. “generally had a higher resistance

to most viruses rarely suffering more than typical childhood symptoms of nasal/sinus

congestion and to a much lesser duration than what [petitioners] saw with his sisters.”

(Id. at ¶ 11.)

Petitioners were required “to administer the Hep B vaccine prior to school entry,”

and R.F. received the vaccine at his pediatrician’s office. (Ex. 1, ¶¶ 12, 14.) After

receiving the first vaccine, petitioner testified that R.F. developed colorblindness. (Id. at

¶16.) R.F.’s second Hep B vaccination was delayed due to illness, however, he

eventually received it on December 4, 2014. (Id. at ¶ 18.) After his appointment, R.F.

“was very tired and had little appetite,” however, petitioner felt this was normal, given

R.F.’s anxiety. (Id.) The next day, while driving R.F. and his siblings home from school,

petitioner noticed that R.F. had developed a chocking cough. (Id. at ¶ 19.) When

petitioner got her children home and out of the car, she turned around to find R.F.

standing by the car, “completely pale,” and, when they eventually got him inside, his

legs buckled. (Id. at ¶¶ 19-20.) Petitioner took R.F. to urgent care after his condition

did not improve. (Id. at ¶ 20.)

By the time petitioner and R.F. made it to urgent care, R.F. “was showing

cognitive deficits and appeared to be losing consciousness.” (Ex. 1, ¶ 21.) R.F. was

hypotensive and hypothermic and his bloodwork showed that he had a blood infection,

and his WBC was elevated. (Id. at ¶¶ 21-22.) R.F. was taken by ambulance to the

hospital, and he was given IV antibiotics. (Id. at ¶ 24.) Petitioner explained that the

only thing out of the ordinary that R.F. had been exposed to was the vaccine. (Id.)

Petitioner goes on to summarize R.F.’s medical history, which is summarized, in detail,

above. (Id. at ¶¶ 26-37.)

Petitioner testified that, since December of 2014, R.F. has had between six and

seven hypotensive and hypothermic episodes per year. (Ex. 1, ¶ 37.) Petitioner

testified that R.F.’s subsequent episodes have been triggered by viral infections, instead

of vaccinations. (Id.) Petitioner testified that R.F.’s condition has significantly impacted

their lives. (Id. at ¶ 38.) Petitioner specifically described two episodes after R.F. had a

respiratory infection in July of 2017. (Id. at ¶ 39.) Petitioner testified that R.F. “does

have immunity to all previously administered vaccines which is comforting considering

he is still medically exempt from further vaccination in the continued absence of a

diagnosis.” (Id. at ¶ 40.) In October of 2017, R.F. was diagnosed with osteopenia after

9

breaking his wrist. (Id. at ¶ 41.) Petitioner testified that this was surprising because,

before receiving his second hepatitis B vaccination, R.F. had broken his arm, and had

no signs of osteopenia. (Id.)

Petitioner explains that R.F. does not have an official diagnosis, therefore, “all

that is known is that it began with a Hep B vaccine, but by what mechanism is unclear.”

(Ex. 1, ¶ 42.) Due to his condition, petitioners are “hyper vigilant to R.F.’s condition.”

(Id. at ¶ 43.) R.F. “is at high risk for falls and possible serious injury,” and “heart

complications and loss of oxygen to critical organs.” (Id.) Additionally, R.F. has had to

undergo invasive diagnostic methods that have posed additional complications for R.F.

due to his ADD and Sensory Processing Disorder. (Id. at ¶ 44.) Petitioner testified that

“R.F.’s complaints referenced above and those contained in his medical records were

caused-in-fact by the Hepatitis B vaccination received on December 4, 2014.” (Id. at ¶

45.)

IV. Expert Opinions

a. Petitioner’s expert, Ravi Durvasula, M.D.8

After reviewing R.F.’s history, Dr. Durvasula opined that his “health took a very

different course following his hepatitis B vaccines.” (Ex. 22, p. 4.) Dr. Durvasula

explained that prior to vaccination, R.F. had “no particular immune deficiency, disease

vulnerability[,] or developmental disorder.” (Id.) He opines that R.F.’s prematurity at

birth and resulting complications cannot explain his immunologic picture. (Id. at 5.)

After his second hepatitis B vaccination, however, he suffered an “initial reaction

characterized by leukocytosis, hypothermia and hypotonia” that Dr. Durvasula opines

constituted “a clear systemic inflammatory response to vaccination.” (Id. at 4.)

Thereafter, R.F. continued to experience subsequent episodes “all presumably triggered

by viral illnesses” and with “[n]o clear association between these episodes and

additional vaccines.” (Id.) Because etiologies such as bacterial sepsis, seizures, or

cardiovascular disease were excluded, Dr. Durvasula concludes an exaggerated

immune response to vaccination was “the most likely cause.” (Id.) Further to this, Dr.

Durvasula stresses that R.F. was ultimately found to suffer osteopenia post-vaccination,

which is very abnormal for a child and is associated with chronic immunologic disease.

(Id. at 5 (citing Rainer H. Straub et al., Evolutionary Medicine and Bone Loss in Chronic

Inflammatory Diseases – A Theory of Inflammation-Related Osteopenia, 45 SEMINARS

ARTHRITIS & RHEUMATISM 220 (2015) (Ex. 24)).) Thus, he opines that the exaggerated

response to vaccination is the cause of R.F.’s ongoing immune system dysregulation

and resulting recurrent sepsis-like episodes. (Id.)

8 Dr. Ravi Durvasula received both a bachelor’s in biology and his medical degree from McGill University.

(Ex. 23, p. 1.) He completed a residency in internal medicine at Baylor College of Medicine and a

fellowship at Yale University School of Medicine in infectious diseases. (Id. at 3.) Dr. Durvasula currently

works as 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, over 90 peer reviewed abstracts and

conference proceedings, and five books. (Id. at 5-14.)

10

Dr. Durvasula suggests his opinion is in agreement with two treating physicians

who opined that R.F. had suffered a “hyperimmune reaction” as distinct from an allergic

reaction (immunologist Dr. Oppenheimer) or an “immune hypersensitivity reaction”

(primary care provider Dr. Siegel). (Ex. 22, p. 4 (citing Ex. 2, pp. 2-3; Ex. 6, p. 32).) Dr.

Durvasula acknowledges that this is a “very rare complication” for which there is no

specific test that could prove the connection to the vaccination. (Id.) However, he

indicates that “the link between the vaccine, subsequent viral challenges and a severely

exaggerated immune cascade resembling shock is plausible.” (Id.) He indicates that

“[a]ctivation of the immune system, the very basis of vaccines, can become

dysregulated and several triggers – medications, autoimmune signals and infectious

pathogens – play etiologic roles.” (Id.) He suggests that “[t]hermal regulation,

hemodynamic stability and level of arousal may all be correlated with immune-reactive

molecules” and that “[s]uch highly exaggerated responses have been reported in the

literature and abnormal profiles of immunity, though rare, are described.” (Id. at 4-5

(citing L. Beretta et al., Churg-Strauss Vasculitis with Brain Involvement Following

Hepatitis B Vaccination, 19 CLINICAL & EXPERIMENTAL RHEUMATOLOGY 757 (2001) (Ex.

25); Nancy Agmon-Levin et al., Vaccines and Autoimmunity, 5 NATURE REVS.

RHEUMATOLOGY 648 (2009) (Ex. 26)).)

Dr. Durvasula disagrees with Dr. Gans’s opinion on respondent’s behalf that R.F.

suffered a chronic pre-existing immune condition. (Ex. 27, p. 1.) He stresses that there

is a clear association between the onset of R.F.’s symptoms and his hepatitis B

vaccination. (Id.) Thus, especially because Dr. Gans does not identify a specific

condition, he charges that “[t]here is no causal evidence for this argument and it is

simply a refusal to acknowledge the prospect of vaccine-induced hyperimmune

responses without offering an etiology.” (Id.) Dr. Durvasula also disagrees that R.F.’s

condition can be explained as Postural Orthostatic Tachycardia Syndrome (“POTS”).

(Id.) Although POTS was included in at least one differential diagnosis, R.F.’s medical

evaluations were inadequate to support such a diagnosis and his clinical history does

not indicate that his condition is postural, which is the core basis for diagnosing POTS.

(Id.) Whereas Dr. Gans stresses a lack of biologic data to support a causal link to

vaccination, Dr. Durvasula counters that “this case relies on clinical data and physicians’

records. The biologic basis of such reactions I not part of clinical evaluation and

absence of such data should not be used to dismiss this claim.” (Id. at 1-2.)

b. Respondent’s expert, Haley Gans, M.D.9

9 Dr. Hayley Gans received a bachelor’s in biochemistry from Connecticut College and her medical

degree from SUNY Health Science Center at Syracuse. (Ex. B, p. 1.) 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

published 30 peer review articles, nine book chapters, and 34 abstracts. (Id. at 5-10.)

11

Based on her review of R.F.’s medical history, Dr. Gans concludes that R.F. has

suffered an unnamed condition without any known specific etiology. (Ex. A, p. 4.) She

acknowledges that the frequent episodes associated with infectious triggers, history of

allergic tendencies, and family history of autoimmunity has led to a working diagnosis of

self-limited “allergic-like” responses; however, she stresses that R.F.’s condition is

chronic and lacks a single inciting event. (Id.) She notes that the hepatitis B vaccine

has been associated with anaphylaxis, but not chronic conditions. (Id. at 5 (citing

Kathleen R. Stratton, et al., Summary of a Report from the Institute of Medicine, 271 J.

AM. MED. ASS’N 1602 (1994) (Ex. A, Tab 5); Julie Mouchet et al., Hepatitis B Vaccination

and the Putative Risk of Central Demyelinating Diseases – A Systematic Review and

Meta-Analysis, 36 VACCINE 1548 (2018) (Ex. A, Tab 6)).) She further notes that a

seizure disorder has not been entirely ruled out and that an alternative working

diagnosis of POTS has also been proposed. (Id. at 4-5.) Although Dr. Gans appears to

acknowledge that a POTS diagnosis has not been made in this case, she opines that it

is a good fit for his clinical history of episodic lightheadedness, brain fog, and

exaggerated heart rate, as well as his family history of autoimmunity. (Id. at 5.)

Dr. Gans agrees that it may have initially been reasonable to investigate whether

R.F.’s December 2014 event was a response to his vaccination; however, “this is not a

reasonable assumption over time when the events are recurrent and occur after a

heterogenous group of inciting events.” (Ex. A, p. 5.) According to Dr. Gans, “what is

clear is that over time, as R.F. has experienced more episodes and more evaluations

have occurred, his treating physicians have begun to understand R.F.’s chronic

condition better.” (Ex. C, p. 1.) She continues

Over time the allergy/immunology physician, using all of the clinical and

laboratory information, concluded that R.F. did not have anaphylaxis, SIRS

and hyperimmune response and 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; that these recurrent

episodes would occur with many different triggers.

(Id. (citing Ex. 2, pp. 2-10; Ex. 4, pp. 1-9; Ex. 21, pp. 1-3).)

Dr. Gans charges that Dr. Durvasula’s opinion lacks any evidence beyond

temporality to implicate R.F.’s vaccination as an inciting trigger. (Ex. C, p. 1.) Further,

Dr. Gans disagrees with the characterization of R.F.’s condition as “sepsis-like.” (Id. at

2.) She explains that neither a sepsis-like condition nor a SIRS would self-resolve in

hours. (Id. at 2-3; Ex. A, p. 5.) SIRS in particular is not a recurrent condition.10 (Ex. C,

p. 3.) Dr. Gans also challenges Dr. Durvusla’s reliance on a hyperimmune response.

She indicates no biologically plausible explanation has been offered to explain how a

10 Quoting the International Consensus Statement on Pediatric Sepsis (not filed), Dr. Gans characterizes

SIRS as “when a child has an abnormality of temperature (fever of hypothermia) or age-specific

abnormality of the white blood cell count and one of the following: tachycardia, bradycardia, respiratory

distress, or pulmonary condition requiring mechanical ventilation,” which she opines is “clearly” not

consistent with R.F.’s presentation. (Ex. C, p. 3.)

12

hyperimmune response to vaccination would lead to later hyperimmune responses to

subsequent unrelated infectious exposures. (Ex. A, p. 5.) Dr. Gans explains that

The biologic process in hypersensitivity is an abnormal reaction to a specific

antigen which occurs in one of two ways, from either preformed IgE

antibodies to a specific protein or antigen (which is the immediate form) or

from T-Cells also to a specific protein or antigen (which is the delayed form).

The hypersensitivity reaction occurs only to the specific protein or antigen,

and only recurs upon re-exposure to this particular antigen, not unrelated

antigens.

(Ex. C, pp. 2-3 (emphasis original).)

Dr. Gans contends that Dr. Durvasula’s reliance on publications by Staub, et al.,

Beretta, et al., and Agmon-Levin, et al., are inapposite as they involve different

conditions and the reactions discussed in those publications do not fit R.F.’s history.

(Ex. A, pp. 5-6 (citing Straub et al., supra, at Ex. 24; Beretta et al., supra, at Ex. 25;

Agmon-Levin et al., supra, at Ex. 26).) To the extent Dr. Durvasula invokes triggers of

autoimmune disease, he has not identified any autoimmune disorder as being at issue.

(Ex. C, p. 3.)

In her second report, Dr. Gans further questions whether R.F.’s episodes are

actually associated with viral illnesses, which would point away from an immunologic

basis for the condition. (Ex. C, p. 2.) Dr. Gans opines that “R.F. has an underlying

condition, the cause of which is likely genetic, with manifestations after variable triggers.

These triggers do cause the clinical signs and symptoms but do not cause the

underlying condition.” (Id. at 3.) Thus, while the vaccination may have been temporal

to the first episode, the condition otherwise operates independently of the vaccination.

(Id. at 3-4.)

V. Party Contentions

a. Petitioners’ motion

Petitioners explain that their theory under Althen prong one is based on their

assertion that “R.F. suffered a systemic inflammatory response syndrome reaction to

vaccination.” (ECF No. 76, p. 31.) They contend that, although no conclusive

diagnostic test is available, “the link between the vaccine, subsequent viral challenges

and a severely exaggerated immune cascade resembling shock is likely.” (Id. at 32.) In

support of this position, petitioners cite at turns Dr. Durvasula’s explanation of

hypersensitivity reactions and literature addressing triggers of autoimmunity. (E.g., id.)

They further stress the proposed mechanism of action included in the Beretta, et al.,

case report of Churg-Strauss vasculitis following the hepatitis B vaccine, which involves

proinflammatory cytokines recruiting mononuclear cells to lead to local tissue damage.

(Id. at 33 (citing Beretta et al., supra, at Ex. 25).) According to petitioners’, the article by

13

Straub, et al., additionally shows that bone loss is associated with immune

inflammation. (Id. at 34-35 (discussing Straub et al., supra, at Ex. 24).)

Regarding Althen prong two, petitioners stress that prior to his hepatitis B

vaccines, there is no evidence that R.F. was suffering any immune disorder; however,

his health took a very different course subsequent to vaccination. (ECF No. 76, pp. 35-

36.) Thus, Dr. Durvasula opines that “there is a clear association between onset of

R.F.’s symptom complex and hepatitis B vaccination.” (Id. at 35 (quoting Ex. 27, p. 1).)

Further to this, petitioners argue that two of R.F.’s treating physicians, Drs.

Oppenheimer and Siegel, reached the same conclusion as Dr. Durvasula – that R.F.

experienced a hyperimmune reaction. (Id. at 36.) Moreover, the fact that R.F. has been

diagnosed with osteopenia at age 9 supports immune dysregulation and chronic

inflammation as the process underlying R.F.’s clinical syndrome. (Id. at 36-37.)

Petitioners contend that their proposed explanation of events is more likely than the

idea that onset of R.F.’s condition was merely coincident to vaccination. (Id. at 37.)

Regarding Althen prong three, petitioners argue that onset of R.F.’s syndrome in

the form of an acute reaction one day post-vaccination constitutes an appropriate

temporal relationship. (ECF No. 76, p. 37.) Indeed, they urge that “temporality

following vaccination is a major piece of the clinical picture.” (Id.) However, petitioners

do not actually explain the temporal relationship in their brief.

Regarding respondent’s ability to identify any factor unrelated to vaccination as

the cause of R.F.’s condition, petitioners stress that respondent has not explained any

alternative cause. (ECF No. 76, pp. 38-39.) To the extent Dr. Gans invoked POTS,

petitioners dispute that R.F. can reasonably be diagnosed with POTS. (Id. at 37.)

b. Respondent’s response

As a threshold issue, respondent contends that an Althen analysis is not even

necessary, because petitioners have failed to demonstrate that R.F. suffered either

SIRS or any hypersensitivity reaction as alleged. (ECF No. 81, p. 23.) While

respondent acknowledges that Dr. Gans could not otherwise identify R.F.’s condition,

he stresses that SIRS and/or a hypersensitivity reaction cannot explain R.F.’s chronic,

recurrent condition. (Id. at 23-25.)

Regarding Althen prong one, respondent contends that petitioners have not

demonstrated any sound and reliable medically theory supporting the hepatitis B

vaccine as a cause of R.F.’s claimed injuries. (ECF No. 81, p. 25.) Respondent

contends that, while the hepatitis B vaccine can cause anaphylaxis, it is not known to

cause any chronic condition and Dr. Durvasula himself characterized his theory of

immune dysregulation as entirely unsupported by diagnostic testing and instead based

on merely “plausible” association, which does not meet petitioners’ preponderant

burden of proof. (Id. at 26-27 (quoting Ex. 22, p. 5).) R.F. does not have any of the

autoimmune conditions discussed in the literature cited by Dr. Durvasula. (Id. at 27.)

Respondent also challenges the relevance of the relationship between chronic

14

inflammatory diseases and osteopenia, because R.F. had only episodic reactions to

stimuli rather than any chronic inflammatory disease. (Id. at 28.)

Regarding Althen prong two, respondent stresses that just prior to the

vaccination at issue R.F. had also recently suffered an upper respiratory infection.

(ECF No. 81, p. 29 (citing Ex. 5, p. 12; Ex. 11, pp. 2-5).) He acknowledges that the

treating physicians noted the temporal proximity of R.F.’s first episode to vaccination but

contends this does not support petitioners’ claim for two reasons. (Id. at 30.) First,

considering R.F.’s medical history as a whole, later medical records expressed doubt

that the vaccination was implicated after the subsequent episodes occurred. (Id. (citing

Ex. 21, p. 3).) Second, the records of Drs. Oppenheimer and Siegel cited by petitioners

are more equivocal regarding vaccine causation than petitioners suggest. (Id. at 30-32.)

Further, respondent contends that Dr. Siegel did not reach an independent assessment

of R.F.’s initial episode, but merely documented the prior assessments of the other

treating physicians. (Id. at 32.) In any event, even if the treating physicians did opine in

a manner supportive of petitioners’ claim, these opinions must still be assessed for their

reliability. (Id.) Petitioners’ expert, Dr. Durvasula, provided no evidence, apart from

temporality of the first episode, to support his hypothesis of a SIRS or hyperimmune

response. (Id. at 34.) However, respondent stresses the importance of evaluating

R.F.’s condition based the broader history of recurrent episodes. (Id. at 33.)

Regarding Althen prong three, respondent contends that “[i]t is impossible to

know what an appropriate temporal association between vaccination and R.F.’s

condition would be, as the condition is unknown, and the timeline is complicated by the

recurrent, ongoing episodes in response to unknown causes.” (ECF No. 81, p. 34.)

Therefore, respondent contends that petitioners have not met their burden under Althen

prong three.

c. Petitioners’ reply

In reply, petitioners stress that their amended petition alleged SIRS and further

explained that “[a]lthough his immediate systemic response eventually subsided, it left

R.F. with a pronounced immune system dysregulation, such that a new immune system

provocation leads to another, predictable event.” (ECF No. 82, pp. 1-2 (quoting ECF

No. 29, ¶ 32).) Petitioners further argue that R.F.’s initial episode meets the criteria for

SIRS. (Id. at 2-3.) Therefore, petitioners contend that they have both pled and

substantiated a specific injury. (Id. at 3-4.)

In response to respondent’s Althen prong one arguments, petitioners dispute that

the literature respondent has cited shows the hepatitis B vaccine to be considered safe.

Petitioners stress that while vaccinations are safe at a population level, this does not

preclude rare adverse events. (ECF No. 82, pp. 6-7.) Moreover, the publications cited

by respondent are not conclusive. (Id. at 7.) Regarding respondent’s urging that Dr.

Durvasula lacks supporting clinical evidence, petitioners stress that what Dr. Durvasula

acknowledged was that “testing for such a response is not in the realm of standard

clinical care.” (Id. at 7- 8 (quoting Ex. 22, p. 5).) Petitioners argue that they should not

15

be held to account for what testing is or is not available. (Id. at 8.) Petitioners indicate

that it is a mischaracterization of Dr. Durvasula’s opinion to suggest he opined based on

mere plausibility and stress that they are not arguing that plausibility is their burden of

proof. (Id. at 8-9.)

Regarding Althen prong two, petitioners disagree with respondent’s assessment

of Drs. Oppenheimer’s and Siegal’s opinions. (ECF No. 82, pp. 10-14.) Petitioners

stress that it is not the role of treating physicians to flesh out a medical theory of

causation, that the records include “incredibly powerful language supporting [a] vaccine

reaction,” and that picking apart the treaters’ thought process creates an impossible

burden for petitioners. (Id. at 14.) Petitioners charge that respondent’s position

amounts to asserting that any time a treating physician records an impression that does

not support respondent’s view, then that physician “must not have thought things

through correctly.” (Id. at 13-14.)

Regarding Althen prong three, petitioners cite a prior case in which respondent

presented two experts who opined that the SIRS manifests immediately after a

triggering event. (ECF No. 82, pp. 14-15 (citing Ahlum v. Sec’y of Health & Human

Servs., No. 12-763V, 2018 WL 4323623, *44 (Fed. Cl. Spec. Mstr. Aug. 16, 2018).)

VI. Analysis

As discussed above, petitioner’s burden in a cause-in-fact claim is to show the

three-part Althen test, which includes (1) a general theory of causation implicating the

vaccine as a cause of the alleged condition, (2) a logical sequence of cause and effect

implicating the vaccination as a cause of petitioner’s own condition, and (3) appropriate

timing of onset based on the theory of causation, by a preponderance of evidence. 418

F.3d at 1278. In this case, the parties present issues with respect to all three Althen

prongs.11

Importantly, petitioners’ claim has two components. First, petitioners have

confirmed in their briefing that they are asserting that R.F. experienced a

hypersensitivity reaction to his hepatitis B vaccine that resulted in SIRS. Second, they

also contend that, although the initial episode subsided, it resulted in “a pronounced

immune system dysregulation, such that a new immune system provocation leads to

another, predictable event.” (ECF No. 82, p. 2 (quoting ECF No. 29, ¶ 32).) This latter

assertion is crucial to petitioners’ case.

11 If one assumes that R.F. suffered a life-long immune disorder as respondent implicitly argues, then

arguably this case should be evaluated under the Loving test for significant aggravation. See Loving ex

rel. Loving v. Secretary of Health & Human Servs., 86 Fed. Cl. 135 (2009). However, this approach was

not discussed by either party. Petitioners, in particular, argue that R.F.’s condition arose de novo post

vaccination. In any event, there is no debate between the parties that R.F.’s post-vaccination episode

was the first clinical indication that he had any kind of immune disorder. Accordingly, any analysis under

Loving prongs one through three would readily identify a worsening of R.F.’s condition occurring post-

vaccination. The remaining elements of the Loving test would remain the same as the Althen analysis

below. Thus, conceptualizing this case as one of significant aggravation would not change the outcome.

16

Because R.F.’s initial episode, allegedly a vaccine-caused hypersensitivity

reaction resembling SIRS, did not in itself persist for at least six months and did not

result in either death or surgical intervention, it does not standing alone meet the

Vaccine Act’s statutory severity requirement. § 300aa-11(c)(1)(D)(i). Therefore,

petitioners only state a compensable claim if they can present a medical theory and

logical sequence of cause and effect demonstrating not only that a hepatitis B vaccine

can cause a hypersensitivity reaction, but also that R.F.’s alleged post-vaccination

hypersensitivity reaction was in turn the cause of the alleged chronic immune system

regulation they additionally assert as the second component of their claim.12 Wright ex

rel. B.W. v. Sec’y of Health & Human Servs., 22 F.4th 999, 1005 (Fed. Cir. 2022)

(holding that for purposes of § 300aa-11(c)(1)(C)(ii) a vaccine injury must be a

substantial contributing factor and but for cause of any complications or residual effects

under § 300aa-11(c)(1)(D)(i)).

a. Althen prong one

Under Althen prong one, petitioners must provide a “reputable medical theory,”

demonstrating that the vaccine received can cause the type of injury alleged. Pafford v.

Sec’y of Health & Human Servs., 451 F.3d 1352, 1355-56 (Fed. Cir. 2006) (quoting

Pafford v. Sec’y of Health & Human Servs., No. 01-0165V, 2004 WL 1717359, at *4

(Fed. Cl. Spec. Mstr. July 16, 2004)). Such a theory must only be “legally probable, not

medically or scientifically certain.” Knudsen ex rel. Knudsen v. Sec’y of Health &

Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Petitioners may satisfy the first

Althen prong without resort to medical literature, epidemiological studies, demonstration

of a specific mechanism, or a generally accepted medical theory. See Andreu ex rel.

Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009)

(citing Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325-26 (Fed. Cir.

2006)). However, although the theory need not be scientifically certain, “it must still be

‘sound and reliable.’” Boatmon ex rel. J.B. v. Sec’y of Health & Human Servs., 941 F.3d

1351, 1359 (Fed. Cir. 2019) (quoting Knudsen, 35 F.3d at 548-49).

According to Dr. Durvasula, what R.F. experienced was an “initial reaction

characterized by leukocytosis hypothermia and hypotonia,” which was later followed by

subsequent similar episodes involving hypothermia, unresponsiveness, and hypotonia,

each presumably triggered by viral illnesses. (Ex. 22, p. 4.) He further characterizes

the initial episode as a hypersensitivity response and as SIRS. (Id. (explaining that the

initial episode “closely resembled a picture of septic shock and is a clear systemic

inflammatory response to vaccination” and expressing agreement with Dr. Siegel’s

diagnosis of hypersensitivity reaction.) Although Dr. Durvasula invokes SIRS as an

12 R.F.’s ophthalmic condition may have separately persisted for greater than six months; however,

despite raising the fact that R.F. began having vision problems subsequent to his first hepatitis B vaccine,

petitioners have not incorporated that aspect of R.F.’s history into their theory. Dr. Durvasula opined that

any relationship between R.F.’s first hepatitis B vaccine and his visual disturbances is “unclear.” (Ex. 22,

p. 3.) At no point did he incorporate R.F.’s ophthalmic issues into his assessment of R.F.’s allegedly

vaccine-caused condition.

17

explanation for the features of R.F.’s initial clinical presentation, he is clear in basing his

underlying causal theory on a hypersensitivity response.13 (Ex. 30, p. 4.) He agrees

that only the first episode was associated with vaccination.14 (Id.) As Dr. Gans

explains, however, hypersensitivity responses are antigen-specific. (Ex. C, pp. 2-3.)

Accordingly, hypersensitivity alone does not explain R.F.’s episodic presentation given

that the later episodes were triggered by other unspecified viral illnesses. Dr. Gans

opines 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.” (Ex. C, p. 2.) Dr. Gans confirms that

hypersensitivity reactions and SIRS are acute responses that do not present chronically

and/or episodically. (Id. at 3.)

After being prompted to explain how a hypersensitivity reaction can be related to

chronic immune dysregulation, Dr. Durvasula asserted that hypersensitivity “often has

features of cross-reaction or molecular mimicry,” which is an invocation of

autoimmunity. (Ex. 30, p. 4; see also Ex. 22, p. 4 (indicating that “[a]ctivation of the

immune system, the very basis of vaccines, can become dysregulated and several

triggers – medications, autoimmune signals and infectious pathogens – play etiologic

roles.”)) To support that point, Dr. Durvasula relies on a paper by Agmon-Levin, et al.,

for the proposition that autoimmunity can arise in susceptible individuals as a result of

environmental triggers, including from vaccine antigens that stimulate the innate and

adaptive immune responses. (Ex. 30, p. 4 (quoting Agmon-Levin et al., supra, at Ex.

26, p. 2).) Apart from his citation to Agmon-Levin, Dr. Durvasula has not otherwise

articulated how R.F.’s alleged post-vaccination hypersensitivity reaction could have led

to the chronic state of immune dysregulation he posits.

Dr. Durvasula glosses over the details of the proposed relationship between

hypersensitivity and autoimmunity. Indeed, Dr. Durvasula does not even clarify what

type of hypersensitivity he is invoking. (Compare Ex. 30, p. 4 (invoking either

immediate or delayed hypersensitivity) and Ex. C, p. 2 (explaining immediate and

delayed hypersensitivity as involving different mechanisms).) For its part, the Agmon-

Levin paper couches hypersensitivity and autoimmunity as two distinct concepts,

13 Specifically, he explains that hypersensitivity reactions “result in widespread activation of the immune

system resulting in both cellular and humeral derangements that manifest as hypersensitivity. These

reactions may be immediate or delayed and manifestations can overlap with clinical features of Systemic

Inflammatory Response Syndrome.” (Ex. 30, p. 4.)

14 Although Dr. Gans stresses in her first report that the hepatitis B vaccine is “safe and efficacious,” that

discussion is explicitly limited to “chronic conditions.” (Ex. A, p. 5.) Dr. Gans suggests that Dr. Durvasula

has not substantiated any causal relationship between R.F.’s hepatitis B vaccine and his condition and

contends that his overall chronic, episodic condition is not consistent with either SIRS or a

hypersensitivity reaction. (Id. at 4-5.) However, nowhere in either of her reports does she suggest that,

as a general matter, a vaccine cannot cause these types of acute immune reactions. She acknowledges,

for example, that the hepatitis B vaccine can cause anaphylaxis acutely. (Id. at 5.) In her second report,

Dr. Gans appears to explain without any apparent qualification that any antigen has the potential to result

in a hypersensitivity reaction. (See Ex. C, pp. 2-3.) Because this decision turns on other factors, I will

simply assume without deciding that the hepatitis B vaccine can cause hypersensitivity reactions.

18

without discussing the former as a cause of the latter. (Agmon-Levin et al., supra, at

Ex. 26.) But in any event, even if accepting 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.

There is no question that autoimmunity is an established category of disease that can,

in at least some instances, be linked to vaccination. See 42 CFR § 100.3(b)(15).

However, there are various pathways to autoimmunity and many autoimmune

conditions have little to no suspicion of vaccine causation. E.g. Kelly v. Sec’y of Health

& Human Servs., No. 16-1548V, 2023 WL 3274159, at *19 (Fed. Cl. Spec. Mstr. May 5,

2023) (explaining that “[t]here is little debate that myasthenia gravis is an autoimmune

neuromuscular disorder and there is little debate that molecular mimicry is, in general, a

viable theory of autoimmunity that can in at least some contexts implicate vaccination.

Importantly, however, these predicates are not enough to meet petitioner’s burden of

proof.”); Casazza v. Sec’y of Health & Human Servs., No. 17-947V, 2023 WL 6214984,

at *10 (Fed. Cl. Spec. Mstr. Aug 30, 2023) (explaining “there is no dispute that

[rheumatoid arthritis] is an autoimmune condition of uncertain cause” and that [v]ery

little on this record apart from Dr. Gershwin’s say-so associates any vaccine with

[rheumatoid arthritis] whereas much more purports to refute Dr. Gershwin’s opinion.”)

Despite invoking the concept as the sole explanation for the chronic immune

dysregulation he posits, Dr. Durvasula has not substantiated that autoimmunity is

relevant to this case and has not sufficiently articulated a theory based in autoimmunity.

Although Dr. Durvasula opines that R.F.’s presentation is suspicious for an

autoimmune process, he has not purported to invoke any known autoimmune condition.

Instead, Dr. Durvasula highlights two aspects of R.F.’s chronic condition as pertinent to

his theory. First, he indicates that “[t]hermal regulation, hemodynamic stability and level

or arousal may all be correlated with immune-reactive molecules.” (Ex. 22, p. 4.)

Second, he notes that diffuse osteopenia is associated with chronic immunologic

disease. (Id. at 5.) However, he has not identified any autoimmune condition that could

potentially explain these features as part of its clinical presentation. Nor has he

otherwise identified any autoimmune pathway could theoretically result in such a

presentation. As Dr. Gans has pointed out, R.F. does not have any of the various

autoimmune conditions discussed in any of the literature cited by Dr. Durvasula. (Ex. A,

p. 5; Ex. C, p. 3.) In fact, in reviewing R.F.’s history, Dr. Durvasula observes that

“[e]xtensive immunologic and allergy testing failed to reveal a clear abnormality,

immunosuppressive illness or associated disorder of cellular or humoral immunity.” (Ex.

22, p. 3.)

The Beretta, et al., case report posits that pro-inflammatory cytokines may

ultimately lead to recruitment of tissue damaging mononuclear and T cells; however,

this hypothesis is presented in the context of vasculitis, which is explained as involving

a process whereby the endothelial cells of the blood vessels in particular are affected.

(Beretta et al., supra, at Ex. 25.) Again, however, there has been no assertion that R.F.

suffered vasculitis or that vasculitis could explain R.F.’s clinical presentation. Nothing

on this record substantiates that the mechanism of injury discussed within this case

report can be reasonably generalized to other conditions or invoked to explain a

19

presentation such as in this case. For example, Dr. Durvasula has not even explained

as a general matter his assertion that thermal regulation and hemodynamic stability are

immune-mediated. And, in any event, the case report acknowledges that the

hypothesized mechanism of vaccine-induced vasculitis is still a matter of debate. (Id.)

“Because causation is relative to the injury, a petitioner must provide a reputable

medical or scientific explanation that pertains specifically to the petitioner’s case,

although the explanation need only be ‘legally probable, not medically or scientifically

certain.’” Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1345 (Fed.

Cir. 2010) (quoting Knudsen, 35 F.3d at 548-49).) In that regard, “[m]edical recognition

of the injury claimed is critical and by definition a ‘vaccine-related injury,’ i.e. illness,

disability, injury or condition, has to be more than just a symptom or manifestation of an

unknown injury.” Id. at 1349. Thus, without more, Dr. Durvasula’s broad reliance on an

unspecified autoimmune process fails on a fundamental level. Simply, it is too vague to

preponderantly support a theory of causation. Accord J.F. v. Sec’y of Health & Human

Servs., No. 13-799V, 2022 WL 5434214, at *32 (Fed. Cl. Spec. Mstr. Sept. 9, 2022)

(finding that “petitioner is not persuasive in identifying ASIA as a sound and reliable

means of identifying the presence of an autoimmune injury in those who are not

suffering a defined autoimmune condition. Given that petitioner did not suffer any

recognized autoimmune condition, this is fatal to petitioner's Althen prong one

showing.”)

Dr. Durvasula does more specifically state that hypersensitivity can result in

cross reaction and molecular mimicry, which is a known mechanism of autoimmunity.

(Ex. 30, p. 4.) Molecular mimicry “is a generally accepted scientific principle, [but] mere

invocation of the scientific term does not carry a petitioner’s burden in a Program case.”

Deshler, 2020 WL 4593162, at *20 (citing Forrest v. Sec’y of Health & Human Servs.,

No. 14-1046V, 2019 WL 925495, at *3 (Fed. Cl. Spec. Mstr. Jan. 18, 2019)). Even

accounting for the fact that petitioners are not obligated to demonstrate scientific

certainty, prior cases have expressed with regard to the application of molecular

mimicry that “[t]he line must be drawn somewhere between speculation and certainty.”

Brayboy v. Sec'y of Health & Human Servs., No. 15-183V, 2021 WL 4453146, at *19

(Fed. Cl. Spec. Mstr. Aug. 30, 2021). Without requiring direct, testable evidence, this

still generally requires some showing of cross-reactive potential affecting the health and

productivity of a bodily tissue or organ. Id. Here, however, Dr. Durvasula merely

references the possibility of cross-reaction. He does not identify any proposed

homology, any relevant autoantibody, or even explain what specific autoimmune target

within the body would be responsible for “[t]hermal regulation, hemodynamic stability

and level or arousal.” (Ex. 22, p. 4.)

Dr. Durvasula stresses that

Though a variety of cellular assays could be done under laboratory

conditions to elucidate the link between vaccine and environmental virus

antigens and R.F.’s immune reactions, this case relies on clinical data and

physicians’ records. The biological basis of such reactions is not part of

20

clinical evaluation and absence of such data should not be used to dismiss

this claim.

(Ex. 27, pp. 1-2.) However, petitioners’ burden under Althen prong one is to

demonstrate general causation, which is not restricted to an examination of R.F.’s own

history. Accordingly, the limits of R.F.’s own clinical evaluation are not a reason for Dr.

Durvasula to entirely side-step any substantiation of the biological basis for his theory.

Nothing requires the acceptance of an expert’s conclusion “connected to existing data

only by the ipse dixit of the expert,” especially if “there is simply too great an analytical

gap between the data and the opinion proffered.” Snyder ex rel. Snyder v. Sec’y of

Health & Human Servs., 88 Fed. Cl. 706, 743 (2009) (quoting Gen. Elec. Co. v. Joiner,

522 U.S. 136, 146 (1997)); see also Isaac v. Sec’y of Health & Human Servs., No. 08-

601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), aff’d, 108 Fed. Cl.

743 (2013), aff’d, 540 F. Appx. 999 (Fed. Cir. 2013). The Court of Federal Claims has

previously explained that, while the Althen Court rejected the need for scientific

certainty, “[t]he standard of proof does not operate as a sliding scale that varies

depending upon the quantity and quality of the scientific evidence that is available.”

Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. 119, 143 (2011), aff’d, 463 F.

App’x 932 (Fed. Cir. 2012). Here, while the limits of clinical evaluation have some

bearing on what evidence petitioners can reasonably be expected to muster relative to

Althen prong two, such limitations cannot explain the dearth of evidence or explanation

supporting Dr. Durvasula’s opinion regarding general causation.

Considering all of the above, Dr. Durvasula’s opinion does not preponderantly

establish 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.

Therefore, petitioners have not met their preponderant burden of proof with respect to

Althen prong one.15

15 I note that there is one prior Court of Federal Claims decision in which a special master was found to

have erred because he effectively required the petitioner to “demonstrate causation for each recurring

outbreak of a chronic condition triggered by a vaccine and that each recurrence must be separately

analyzed under Althen.” DeLozier ex rel. L.T. v. Sec’y of Health & Human Servs., 152 Fed. Cl. 558, 569

(2021). The instant case is distinguishable. In DeLozier, the special master concluded that petitioner had

established that a child’s vaccination did initially play a causal role in bringing about the autoimmune

condition of alopecia, which was a condition known to have a chronic course that waxed and waned. Id.

at 560. Having concluded that the vaccine played a role in initially causing the condition, the fact that the

condition waxed and waned, consistent with the understood course of such a condition, was not a barrier

to recovery for the entirely of the condition. Id. at 569. Here, however, the initial, allegedly vaccine-

caused, episode, might be a part of a more chronic condition that would appear to present episodically;

however, that condition remains unidentified and the relationship between the initial episode and the

chronic condition is not clear. Moreover, regardless of the nature of that unidentified chronic condition,

respondent and his expert further challenge that the type of immune reaction theorized by petitioners to

explain the initial episode (hypersensitivity or SIRS) can reasonably be implicated as a cause of chronic

immune dysregulation. Accordingly, what was taken for granted in Delozier – that all of the episodes

were manifestations of the underlying condition that was itself vaccine-caused – is a core point of

litigation in this case from which I have concluded that petitioners have not proven their case.

21

b. Althen prong two

The second Althen prong requires proof of a logical sequence of cause and

effect, usually supported by facts derived from a vacinee's medical records. Althen, 418

F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326-27; Grant,

956 F.2d at 1147-48. Medical records are generally viewed as particularly trustworthy

evidence. Cucuras ex rel. Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525,

1528 (Fed. Cir. 1993). However, medical records and/or statements of a treating

physician's views do not per se bind the special master. See § 300aa-13(b)(1)

(providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or

summary shall not be binding on the special master or court”); Snyder, 88 Fed. Cl. at

745 n. 67 (“there is nothing ... that mandates that the testimony of a treating physician is

sacrosanct—that it must be accepted in its entirety and cannot be rebutted.”) A

petitioner may support a cause-in-fact claim through either medical records or expert

medical opinion. § 300aa-13(a). The special master is required to consider all the

relevant evidence of record, draw plausible inferences and articulate a rational basis for

the decision. Winkler v. Sec’y of Health & Human Servs., 88 F.4th 958, 963 (Fed. Cir.

2023) (citing Hines, 940 F.2d at 1528).

i. Treating physician opinions

In their briefing, petitioners stress the opinions of two treating physicians – Drs.

Oppenheimer and Dr. Siegel.16 (ECF No. 82, pp. 10-14.) According to petitioners, their

records include “incredibly powerful language supporting [a] vaccine reaction.” (Id. at

14.) While I agree that these records do state an impression of vaccine-causation vis-à-

vis R.F.’s initial post-vaccination episode, I do not agree that they reliably support

vaccine-causation of R.F.’s condition.

Turning first to Dr. Oppenheimer’s earlier specialist evaluation of April 2, 2015,

he offers two statements that support petitioners’ view. First, addressing R.F.’s

condition as “[s]tatus post episode of hypotonia with systemic complaints following

vaccination to hepatitis B,” he states that “[c]ertainly, it is easy to blame the hepatitis for

this.” (Ex. 2, p. 3.) Second, he explains that “[t]his 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.” (Id.) Dr. Oppenheimer specifies that

he does not believe the episode was an allergic response but does not otherwise

characterize the type of immune response he is considering. Importantly, however,

there are other aspects of Dr. Oppenheimer’s record that are not supportive of

16 In their reply, petitioner’s also quote a record from Phoenix Children’s Hospital as evidence that the

medical records “continue to reflect vaccination involvement.” (ECF No. 82, p. 9 (quoting Ex. 32, p. 20).)

However, this record is not illuminating. The language petitioners’ quote is from the history of present

illness portion of a cardiology consultation, which the record specifies was obtained from petitioners

themselves. (Ex. 32, p. 20.) It does not contain any medical opinion endorsing the reported history of a

vaccine reaction and the cardiologist recorded that the case involved a “confusing clinical situation.” (Id.)

Ultimately the cardiologist’s impression was that “I can not think of any clear unifying cardiac etiology that

would explain his symptoms.” (Id. at 22.)

22

petitioners’ claim. First, Dr. Oppenheimer states that “I wholeheartedly encourage

continued follow up as obviously the differential is protean.” (Id.) Second, he states

that “it would be nice to know what potential triggers may bring this about for future

observation.” (Id.)

Regarding R.F.’s initial post-vaccination presentation, although I agree that Dr.

Oppenheimer’s record includes an impression from a qualified specialist that R.F.’s

initial episode was an immune reaction to the vaccine, it is not ultimately strong

evidence. As respondent stresses, the fact that Dr. Oppenheimer is a treating physician

is not the end of the discussion. (ECF No. 81, p. 32.) The reliability of his impression

must be assessed. In that regard, although Dr. Oppenheimer indicates that it is “easy”

to blame the initial episode on R.F.’s vaccination, there is reason to doubt the factual

assumptions underlying that assessment. In particular, there is no indication that Dr.

Oppenheimer was aware of the fact that R.F. had also been suffering an infection in the

week prior to the episode. (Compare Ex. 2, p. 2 (Dr. Oppenheimer’s April 2015

recorded history making no mention of any upper respiratory infection) and Ex. 5, p. 23

(December 5, 2014 ED triage noting recent URI symptoms) and Ex. 11, p. 4 (December

5, 2014 EMS record stating “Pt was treated for an upper respiratory infection last week,

and has completed a full course of antibiotics.”))17 The omission of this aspect of R.F.’s

history is particularly concerning vis-à-vis Dr. Oppenheimer’s impression because he

separately noted that the fact of a second, questionably viral-related episode, affected

his thinking regarding causation. (Ex. 2, p. 3.) Moreover, in asserting an immune basis

for R.F.’s recurring episodes, petitioners themselves otherwise attribute the episodes to

viral illnesses. (ECF No. 76, pp. 35-37.) Accordingly, the fact that R.F.’s first episode

was preceded not merely by vaccination, but also by a viral illness, has the potential to

be highly significant in that the presence of the viral illness better conforms R.F.’s initial

episode to the overall pattern of his chronic condition.18

Additionally, Dr. Oppenheimer’s documented reasoning is limited and nothing in

Dr. Oppenheimer’s record confirms, for example, that he applied the same reasoning as

Dr. Durvasula in reaching his conclusion as to the initial episode. While petitioners

stress that it is not the role of treating physicians to theorize, the limits of Dr.

Oppenheimer’s assessment remain the limits of his assessment. The fact that Dr.

Oppenheimer did not fully discuss his reasoning is not a basis for speculating that his

reasoning therefore dovetails with that of Dr. Durvasula. In particular, Dr. Oppenheimer

17 As noted in the fact summary above, there are no medical records confirming this reported treatment

with antibiotics, which is concerning. However, nothing in the medical records contradicts the

contemporaneous report of an upper respiratory infection occurring during the week prior to R.F.’s

December 5, 2014 episode. And, even if the single reference to prior antibiotic treatment were somehow

in error, there is at least one other contemporaneous report of a recent upper respiratory infection. (Ex. 5,

p. 23.) In their briefs, petitioners acknowledge these histories without challenging them. (ECF No. 76, p.

8.)

18 Conversely, Dr. Gans raises the separate issue that petitioners’ subsequent reports to R.F.’s treating

physicians appear to suggest in the longer run that R.F.’s episodes may not be related to a viral trigger,

casting at least some doubt on the idea of there being any immunologic basis for the episodes. (Ex. C, p.

2 (citing Ex. 5, pp. 17-19; Ex. 29, p. 32).)

23

did not specify what type of immune reaction he felt explained R.F.’s initial presentation.

In fact, Dr. Oppenheimer’s notation disclaiming an allergic response could potentially

suggest he would disagree that a hypersensitivity response is implicated as the

explanation for R.F.’s initial episode.19 In subsequent encounters, petitioners reported

to other physicians that Dr. Oppenheimer had assessed a “hyper-immune response” to

vaccination. (Ex. 6, p. 32; Ex. 4, p. 6.) Notably, however, when R.F. was subsequently

seen by a different immunologist, that immunologist, Dr. Shimamoto, expressed that he

did not understand what Dr. Oppenheimer meant by “hyper-immune response.” (Ex. 4,

p. 6.) Even after Dr. Shimamoto confirmed in an addendum that he was able to review

Dr. Oppenheimer’s record, he still characterized Dr. Oppenheimer’s encounter as

having provided “no definitive diagnosis.” (Id.)

In any event, even if Dr. Oppenheimer’s assessment was compelling with respect

to R.F.’s initial episode, it does not support petitioners’ broader claim with respect to

R.F.’s chronic course. Dr. Oppenheimer felt it was only “questionable” whether R.F.’s

second episode was triggered by his viral infection and specifically noted that “it would

be nice to know” (i.e., we do not know) what potential triggers cause R.F.’s episodes.

(Ex. 2, p. 3.) Additionally, nothing in Dr. Oppenheimer’s assessment reflects any hint

that he believed R.F. was experiencing an autoimmune process as Dr. Durvasula has

opined. In particular, Dr. Oppenheimer declined to pursue any testing even though

there is testing that can speak to whether autoimmunity may be occurring. Instead, he

stressed that R.F.’s differential diagnosis remained “protean,” (Id.) which I interpret to

mean varied and/or unsettled. Finally, nothing in Dr. Oppenheimer’s record indicates

that he believes R.F.’s initial episode was the cause of his chronic condition, as Dr.

Durvasula opines, rather than simply being a manifestation of his chronic condition, as

Dr. Gans opines. On the whole, Dr. Oppenheimer’s record is ambiguous in that

respect.

Turning then to Dr. Siegel’s later primary care record, he reports as of July 19,

2017, an impression of “immune hypersensitivity reaction by mechanism – pt with very

rare immune reaction seems to have been triggered by Hep B vaccine.” (Ex. 6, p. 32.)

He further explains, however, that R.F. had a prior “extensive work up” and “was seen

by very experienced immunologist in NYC who felt he was having a hyper immune

reaction which was turned on and would cont[inue] to be triggered whenever his

immune system is challenged.” (Id.) For his part, Dr. Siegel indicates that “no

19 An “allergic reaction” is defined, simply, as a “hypersensitivity r[eaction]; used particularly to denote a

type I hypersensitivity r[eaction],” and “hypersensitivity reaction” is defined as “a reaction in which the

body mounts an exaggerated or inappropriate immune response to a substance either foreign or

perceived as foreign, resulting in local or general tissue damage.” Allergic Reaction, DORLAND’S MEDICAL

DICTIONARY ONLINE,

https://www.dorlandsonline.com/dorland/definition?id=102313&searchterm=allergic+reaction (last visited

July 30, 2024); Hypersensitivity Reaction, DORLAND’S MEDICAL DICTIONARY ONLINE,

https://www.dorlandsonline.com/dorland/definition?id=102386 (last visited July 30, 2024). Therefore,

while “allergic reaction” most often refers to type-I, i.e., immediate, hypertensive response, it can also be

used to refer to any of the hypersensitivity reaction types. As discussed under Althen prong one, above,

Dr. Durvasula discussed both immediate and delayed hypersensitivity without specifying which type of

reaction he felt was at issue.

24

treatment plan [is] offered” and he “discussed [that petitioners] will get another opinion

in town on dx [i.e., diagnosis] and management.” (Id.) Considering Dr. Siegel’s record

holistically, and especially given his recommendation that petitioners seek a diagnostic

opinion elsewhere, I agree with respondent that this record is better interpreted as mere

acceptance of Dr. Oppenheimer’s prior evaluation than any independent assessment of

vaccine causation. (ECF No. 81, p. 32.) I do acknowledge that Dr. Siegel’s assessment

did indicate “hypersensitivity reaction by mechanism” while separately describing Dr.

Oppenheimer’s prior assessment more generically as a “hyper immune reaction.” (Ex.

6, p. 32.) As discussed above, Dr. Oppenheimer did not actually assess a

hypersensitivity response specifically. However, to the extent one could therefore

interpret Dr. Siegel as having independently assessed hypersensitivity as the operative

mechanism, the remoteness of his evaluation and his lack of specialization as an

immunologist reduce the value of such an assessment. See Nuttall v. Sec’y of Health &

Human Servs., 122 Fed. Cl. 821, 832-33 (2015) (finding that a treating physician who

“only saw the patient after the injury,” is not entitled to the same amount of weight as a

treating physician “who had observed the patient as the condition unfolded.”)

When petitioners did follow up with a new immunologist at Dr. Siegel’s

suggestion, Dr. Shimamoto assessed R.F. as having a “disorder involving the immune

mechanism – unspecified” and expressed that it is “unclear” why he is having his

repeated spells. (Ex. 4, pp. 4, 6.) Dr. Shimamoto recommended evaluating R.F.’s

infant immunization series to see if there is any pattern fitting a specific immune related

disease, but otherwise suggested that further specialist evaluation in pediatric immune

deficiencies would be necessary. (Id. at 6.) Dr. Shimamoto’s assessment is more

consistent with Dr. Gans’s opinion than it is with Dr. Durvasula’s. That is, Dr.

Shimamoto indicates that, while R.F. likely has an ongoing unidentified immune

disorder, the reason(s) for his repeated episodes (which would include the first,

allegedly vaccine-caused episode) remain unestablished.

In light of all of this, and considering the record as a whole, the medical records

are not entirely devoid of medical opinion at least partly supportive petitioners’ claim;

however, treating physician opinion does not reliably or preponderantly support

petitioners’ claim without more.

ii. Expert opinions

Dr. Durvasula’s opinion is short on explanation of the initial immune response at

issue, which cannot be blamed entirely on the limits of R.F.’s clinical workup. At various

points he indicates that it “resembled a picture of septic shock,” constituted an

“exaggerated immune response,” was a “clear systemic inflammatory response,” was a

“severely exaggerated immune cascade,” was a “hyperimmune response,” constituted a

hypersensitivity reaction, either immediate or delayed, and had clinical features of SIRS.

(Ex. 22, p. 4; Ex. 27, p. 1; Ex. 30, p. 4.) Dr. Durvasula’s reports are imprecise in

seeming to use these terms interchangeably. As Dr. Shimamoto suggested in his

review of Dr. Oppenheimer’s evaluation, it is not clear whether “hyperimmune response”

has any specific pathophysiologic meaning. (Ex. 4, p. 6.) And, as noted under Althen

25

prong one, Dr. Durvasula acknowledges that there are different mechanisms of

hypersensitivity, though he does not specify which he is invoking. (See Ex. 30, p. 4.)

Dr. Durvasula expressed agreement that the condition was neither anaphylaxis nor an

allergic reaction, but otherwise indicated that “[t]he biological basis of such reactions is

not part of clinical evaluation . . .” (Ex. 22, p. 4; Ex. 27, p. 2.) Thus, his overall

conclusion is limited to characterizing R.F.’s initial episode as a “clinical syndrome”

having an “immunologic nature.” (Ex. 30, p. 2.) Though Dr. Durvasula suggests

hypersensitivity and SIRS may overlap clinically (Ex. 30, p. 4.), Dr. Gans further

explains that the two conditions are distinct. (See Ex. C, pp. 2-3.) Dr. Gans asserts that

R.F.’s initial presentation is not consistent with either hypersensitivity or SIRS,

explaining that neither condition is likely to self-resolve within hours as R.F.’s episode

did. (Ex. A, p. 5.) Dr. Durvasula has not effectively addressed that point in his

responsive reports.

Additionally, it should be noted that Dr. Durvasula mischaracterizes the

difference of opinion between himself and Dr. Gans regarding R.F.’s more chronic

course. Specifically, he asserts of Dr. Gans’s opinion:

An unnamed and unspecified chronic disorder cannot be used as a basis

for rebuttal of this claim. There is no causal evidence for this argument and

it is simply a refusal to acknowledge the prospect of vaccine-induced

hyperimmune responses without offering an etiology. Furthermore, there is

a clear association between onset of R.F.’s symptom complex and hepatitis

B vaccination. No symptoms were noted prior to administration of vaccines.

(Ex. 30, p. 3.) However, the issue in this case is not whether the presence of an

unspecified chronic condition rebuts Dr. Durvasula’s opinion.

As discussed above, while Dr. Durvasula does posit a mechanism of

hypersensitivity with respect to R.F.’s initial post-vaccination episode, petitioners’ claim

hinges on the relationship between that episode and R.F.’s more chronic, episodic

presentation. In that regard, Dr. Durvasula has based his opinion on the concept of

autoimmunity without identifying any actual autoimmune condition that can explain

R.F.’s presentation. Thus, Dr. Gans and Dr. Durvasula are actually in agreement that

R.F. suffers an unnamed and unspecified chronic disorder and Dr. Durvasula relies on

the presence of such a disorder to the same extent as Dr. Gans. Where the experts

differ is instead only with regard to the relationship between R.F.’s initial episode and

his chronic condition.

Without knowing what the chronic condition actually is, it is speculative to reach

any conclusion one way or the other as to whether the initial episode was the cause of

that condition, as Dr. Durvasula opines, or merely a manifestation of the condition, as

Dr. Gans opines. This remains true regardless of the fact that Dr. Durvasula purports to

identify the chronic condition as being an immune condition of some kind. As discussed

under Althen prong one, Dr. Durvasula acknowledged that “[e]xtensive immunologic and

allergy testing failed to reveal a clear abnormality, immunosuppressive illness or

26

associated disorder of cellular or humoral immunity.” (Ex. 22, p. 3.) Thus, Dr. Gans

persuasively charges that Dr. Durvasula’s position is unsupported. As Dr. Gans

explains “while Dr. Durvasula’s report is a thorough account of R.F.’s records, it is

devoid of specific causal connections between the cited vaccine responses and R.F.’s

condition. Additionally, plausible biologic evidence for an episodic reaction to different

infectious stimuli has not been presented.” (Ex. A, p. 6.)

Because petitioners bear the initial burden of proof, these limitations are

detrimental to their claim, even as respondent effectively acknowledges that given the

limits of R.F.’s clinical evaluations no other definitive explanation is available. While Dr.

Durvasula portrays his own opinion has having a firmer grounding in the clinical history

as compared to Dr. Gans’s assessment, the above quotation from Dr. Durvasula’s

report reveals that he bases his opinion on temporal association alone, which does not

support petitioners’ burden of proof. Grant, 956 F.2d at 1148. Given that Dr.

Durvasula’s opinion is speculative and that petitioners bear the initial burden of proof,

the fact that Dr. Gans likewise recognizes R.F.’s condition to be unidentified does not

bolster petitioners’ claim. Moreover, like Dr. Oppenheimer, Dr. Durvasula does not

adequately account for the fact that R.F. was reportedly suffering an upper respiratory

infection during the week leading up to his vaccination. (See Ex. 22, p. 3 (describing

R.F.’s history without reference to the upper respiratory infection).) Especially in light of

the assertion that subsequent similar episodes were brought on by viral illnesses, this

dramatically undercuts the purported significance of the temporal relationship to the

vaccination.

For all the reasons discussed above, petitioners have not met their preponderant

burden of proof with respect to Althen prong two.

c. Althen prong three

The third Althen prong requires establishing a “proximate temporal relationship”

between the vaccination and the injury alleged. Althen, 418 F.3d at 1278. A petitioner

must offer “preponderant proof that the onset of symptoms occurred within a timeframe

for which, given the medical understanding of the disorder's etiology, it is medically

acceptable to infer causation.” de Bazan v. Sec'y of Health & Human Servs., 539 F.3d

1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable

timeframe must coincide with the theory of how the relevant vaccine can cause an injury

(Althen prong one's requirement). Id.; Shapiro v. Sec’y of Health & Human Servs., 101

Fed. Cl. 532, 542 (2011), mot. for recons. den’d after remand, 105 Fed. Cl. 353 (2012),

aff’d, 503 F. App’x. 952 (Fed. Cir. 2013); Koehn ex rel. Koehn v. Sec’y of Health &

Human Servs., No. 11-355V, 2013 WL 3214877, at *26 (Fed. Cl. Spec. Mstr. May 30,

2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

As discussed in the factual history above, R.F. received his second hepatitis B

vaccine on December 4, 2014, and he then suffered his first episode, which petitioners

allege is a hypersensitivity reaction resembling SIRS, in the afternoon on the following

day. (Ex. 5, p. 14; Ex. 3.) Petitioners have not substantiated that this timing of onset is

27

medically appropriate on this record. Petitioners cite the opinions of respondent’s

experts in the prior Ahlum case (ECF No. 82, pp. 14-15 (citing Ahlum ex rel. TA v. Sec’y

of Health & Human Servs., No. 12-763V, 2018 WL 4323623, at *38-39 (August 16,

2018)); however, these opinions are not actually a part of the record of this case. On

this record, Dr. Durvasula does not actually identify an appropriate period of onset. To

the extent petitioners urge the same mechanism as discussed in the Beretta, et al.,

case report, I do not see how the timing of onset of that vasculitis case is readily

comparable to the clinical history in this case.

For all these reasons, petitioners have not met their preponderant burden of

proof with respect to Althen prong three. But in any event, even if accepting that the

timing of onset in this case did have the potential to implicate R.F.’s hepatitis B vaccine

as a cause of his initial episode occurring one day later, petitioners’ satisfaction of

Althen prong three would not allow them to prevail given their failure to meet their

burden of proof under either Althen prong one or two. Althen, 418 F.3d at 1278; see

also Grant, 956 F.2d at 1148.

d. This is not a close case

I am mindful that the Federal Circuit has suggested that this program represents

a “system created by Congress, in which close calls regarding causation are resolved in

favor of injured claimants.” Althen, 418 F.3d at 1280. In that regard, I acknowledge that

there are aspects of this case that at first blush appear compelling. R.F., as a minor

child, received a routine vaccination and the next day suffered a frightening episode.

Especially in the absence of a better explanation, his treating physicians initially felt the

circumstances potentially implicated his vaccination. In hindsight, even though this first

episode resolved, it marked a turning point in R.F.’s health and his condition remains

enigmatic, though even the government’s expert agrees he has an ongoing chronic

disorder of some kind that is being episodically triggered. Ultimately, however, this is

not a close case despite these circumstances.

The Vaccine Act only relaxes proof of causation for Table Injuries only. Grant,

956 F.2d at 1147-48. A cause-in-fact claim requires petitioner to do the “heavy lifting” of

affirmatively proving by preponderant evidence that R.F.’s vaccination was the cause of

his injury. Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)

(indicating that in the absence of a Table Injury, “the heavy lifting [of proving causation]

must be done by the petitioner, and it is heavy indeed”); see also Althen, 418 F.3d at

1280 (clarifying that “heavy lifting” characterizes the preponderant evidence standard

and not any heightened burden of proof.) Temporality alone does not establish

causation-in-fact. Grant, 996 F.2d at 1148.

Here, petitioners were unpersuasive in seeking to explain R.F.’s chronic course

as an unspecified autoimmune condition. Thus, even if R.F.’s initial episode was

vaccine related, the relationship between R.F.’s various episodes, and the relationship

between each episode and his unidentified underlying condition, would still remain

entirely unclear. And, although petitioners contend that the chronicity of R.F.’s

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unspecified underlying condition has separately resulted in osteopenia, they have not

identified any condition that marries these two aspects of R.F.’s clinical history as part of

any known clinical presentation. Thus, they have not demonstrated that the individual

episodes of hypothermia/hypotonia are the cause of that osteopenia, have a cumulative

effect, or otherwise change the course of the underlying condition. Because petitioners

bear the initial burden of proof, all of these issues are detrimental to their case.

Petitioners contend that their proposed explanation of events is more likely than

the idea that onset of R.F.’s condition was merely coincident to vaccination. (ECF No.

76, p. 37.) However, for all the reasons discussed above, this decision does not turn on

the notion of coincidence. Even if one were to find R.F.’s hepatitis B vaccine compelling

as a potential trigger of his first episode, this does not lead invariably to the conclusion

that a compensable injury has occurred. Petitioners themselves theorize that each of

R.F.’s episodes have a separate trigger. In that vein Dr. Gans has further explained on

respondent’s behalf that R.F.’s post-vaccination episode can be a manifestation of his

underlying immune disorder without being a cause of the underlying condition. This

reasoning applies regardless of whether R.F.’s vaccination is implicated as a trigger of

that single episode. Standing alone, R.F.’s initial episode alone does not meet the

Vaccine Act’s severity requirement.

VII. Conclusion

R.F. has clearly suffered and for that he and his family have my sympathy.

However, for all the reasons discussed above, petitioners have not demonstrated by

preponderant evidence that his condition was caused by his vaccination. Accordingly,

this case is dismissed.20

IT IS SO ORDERED.

s/Daniel T. Horner

Daniel T. Horner

Special Master

20 In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter

judgment accordingly.

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