Opinion

Faup v. Secretary of Health and Human Services

Court: United States Court of Federal Claims
Filed: Apr 6, 2020
Status: Published
On the bench: Elaine D. Kaplan
Cited by: 0 cases
Authority: More cited than 11.4%

holding that it was legal error for the court of federal claims to “reevaluate[] the evidence and c[ome] to its own findings,” especially regarding fact-intensive conclusions where the “medical evidence of causation is in dispute”

How later courts described this case

holding that it was legal error for the court of federal claims to “reevaluate[] the evidence and c[ome] to its own findings,” especially regarding fact-intensive conclusions where the “medical evidence of causation is in dispute”
finding the failure to consider an expert report was harmless where the report did not contain evidence “that [was] sufficiently detailed or probative of the causation 20 issue to change the outcome determined by the special master”
stating that “while the special master abused his discretion by striking” an expert’s medical report from the record, “it was harmless error to do so,” because the court’s own review of that report showed that it “deserve[d] little or no weight in light of the entire record”

Written by the judges who cited it.

The opinion

In the United States Court of Federal Claims

No. 12-87V

(Filed Under Seal: December 27, 2019 | Reissued: April 6, 2020) *

) Keywords: Vaccine Act; Motion for

LISA FAUP, as Parent of A.F., a minor, ) Review; Systemic Juvenile Idiopathic

) Arthritis (sJIA); Diphtheria-Tetanus-

Petitioner, ) acellular-Pertussis (DTaP) Vaccine;

) Inactivated Polio (IP) Vaccine; Althen

v. ) Causation.

)

SECRETARY OF HEALTH AND HUMAN )

SERVICES, )

)

Respondent. )

)

Sylvia Chin-Caplan, Law Office of Sylvia Chin-Caplan, LLC, Boston, MA, for Petitioner.

Catherine E. Stolar, Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice,

with whom were Gabrielle M. Fielding, Assistant Director, Catharine E. Reeves, Deputy

Director, C. Salvatore D’Alessio, Acting Director, Joseph H. Hunt, Assistant Attorney General.

OPINION AND ORDER

KAPLAN, Judge.

The Petitioner, Lisa Faup, seeks review of a decision dismissing a petition for

compensation issued under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.

§§300aa-1 to -34 (the “Vaccine Act” or “the Act”), as amended, that she filed on behalf of her

daughter, A.F. Dec. on Entitlement, Faup v. Sec’y of Health & Human Servs., No. 12-87V (Fed.

Cl. Spec. Mstr. June 17, 2019), ECF No. 120 (hereinafter the “Decision” or “Dec.”). The Special

Master dismissed the petition based on her conclusion that Petitioner failed to show that the

Diphtheria-Tetanus-acellular-Pertussis (“DTaP”) and inactivated polio (“IP” or “polio”) vaccines

A.F. received on March 13, 2009 caused A.F. to develop systemic Juvenile Idiopathic Arthritis

(“sJIA”).

In her motion for review, Petitioner contends that: 1) the Special Master improperly

heightened her burden of proof by requiring her to prove the validity of the so-called

This opinion was previously issued under seal on December 27, 2019. The parties were given

the opportunity to propose redactions on or before January 10, 2020. Because the parties have

not filed proposed redactions, the Court reissues its decision in its entirety.

“Autoimmune (auto-inflammatory) Syndrome Induced by Adjuvants” theory (“ASIA”),

notwithstanding that her experts’ actual theory was a narrower one specific to A.F.’s medical

history and injury; 2) she ignored some of Petitioner’s evidence regarding causation; and 3) her

decision was not based on the record as a whole. In response, the government argues that the

Special Master applied the correct evidentiary standards and that the record supports the

conclusions she reached regarding Petitioner’s failure to establish causation.

The Court agrees with Petitioner that the Special Master’s decision reflects some

conflation of Petitioner’s specific theory of causation with the more generic ASIA theory. The

Special Master’s error in that regard, however, was a harmless one because the Special Master’s

decision also demonstrates that she rationally concluded based on the evidence before her that: 1)

Petitioner had failed to prove by preponderant evidence the viability of her experts’ specific

theory of causation; and 2) it was more likely that A.F.’s sJIA was triggered by a viral infection

than her vaccinations. The Court further finds unpersuasive Petitioner’s arguments that the

Special Master ignored relevant evidence and/or that her decision was not based on the record as

a whole. In light of the deference the Court owes to the findings and credibility determinations of

special masters under the Vaccine Act, Petitioner’s motion for review must be DENIED.

BACKGROUND

I. Medical History

A.F. was born prematurely on March 9, 2004, the oldest of a set of triplets. Pet’r’s Ex. 1

at 1, 22–23, ECF No. 8-1. She showed no signs of any lasting health concerns at birth. Id. At

seven weeks of age, A.F. was diagnosed with an “innocent heart murmur” but was found

“otherwise normal” by a pediatric cardiologist. Id. at 27–28. A.F. received all of her early

immunizations without incident. Id. at 2.

On March 2, 2009, a pediatrician diagnosed A.F. with an ear infection, known as otitis

media, and prescribed a seven-day course of amoxicillin, an antibiotic. Pet’r’s Ex. 15 at 1, ECF

No. 10-1; Pet’r’s Ex. 1 at 72. Several days later, on March 13, A.F. received her regular DTaP

and polio vaccines. Pet’r’s Ex. 15 at 1.

On March 20, A.F. visited her pediatrician for a maculopapular rash 1 that had developed

on or around March 17. Id.; Pet’r’s Ex. 1 at 16. While at her pediatrician’s office, A.F. did not

have a fever and tested negative for strep throat. Pet’r’s Ex. 1 at 16; Pet’r’s Ex. 11 at 2, ECF No.

8-11. She received prednisone for the rash. Pet’r’s Ex. 15 at 1. A pediatric note from that same

day stated that A.F. “[complains of] . . . [left] elbow [and] wrist pains.” Id. On March 25, A.F.’s

symptoms had worsened, and she returned to her pediatrician for abdominal pain, a swollen

elbow, a painful knee and ankles, and a recurring fever of up to 104 degrees Fahrenheit. Pet’r’s

Ex. 1 at 16. Her pediatrician considered a diagnosis of Henoch-Schönlein purpura (“HSP”). 2

A maculopapular rash is one characterized by “both flat and raised skin lesions . . . [which] are

usually red and can merge together.” Dec. at 3 n.7.

Henoch-Schönlein purpura is “a form of nonthrombocytopenic purpura, sometimes a type of

hypersensitivity vasculitis and sometimes of unknown cause, usually seen in children and

Pet’r’s Ex. 15 at 1. On March 27, A.F. saw an allergist who could not determine whether A.F.’s

rash was allergic or viral but gave her Benadryl to rule out an allergy. Pet’r’s Ex. 3 at 3, ECF No.

8-3. The allergist recommended that A.F. go to the emergency room. Id.

A.F. was admitted to the emergency room at Robert Wood Johnson University Hospital

later that day, where it was noted that she had an itchy “maculopapular rash to her face, trunk,

and extremities, slightly raised, [with] some rashes to her ankles [that were] darker in color[,]

slightly brown and discolored,” and that she experienced “mild difficulty walking due to

discomfort.” Pet’r’s Ex. 2 at 2, ECF No. 8-2. The rash on her “lower extremity” was described as

“with petechia 3 and purpura.” 4 Id. at 4. A.F.’s mother reported that A.F. had a “fever

intermittently over the past 6 days” and that the rash started about ten days earlier as “‘itchy

small pink bumps’ over [her] extremities and buttocks, [which] spread to [the] rest of [her]

body.” Id. at 2. A.F. was diagnosed with HSP and discharged the same day. Id. at 1.

On March 31, A.F. saw an infectious disease specialist at Richmond Pediatrics presenting

with a fever, joint pain, a rash, difficulty walking, and loss of appetite. Pet’r’s Ex. 4 at 1, ECF

No. 8-4. She returned to the same specialist on April 8 and reported a temperature of “102-104

since Saturday . . . [, painful] joints . . . [,] and [swollen] wrists and hands.” Id. at 2. The

specialist documented an impression of “Viral vs. [Juvenile Rheumatoid Arthritis], HSP.” Id.

On April 16, A.F. was seen by Dr. Yukiko Kimura, a pediatric rheumatologist, for an

initial evaluation. Pet’r’s Ex. 5 at 1, ECF No. 8-5. At that time, A.F. “appeared well” and had not

complained of pain for several days. Id. She reported a continuous itchy rash, however, which

worsened when she had a fever. Id. The prednisone prescribed on March 26 “did not seem to

help with the fever,” although Motrin “seem[ed] to help quite a bit.” Id. In a letter summarizing

her evaluations, Dr. Kimura reported that A.F. “received a DTaP/[I]PV on 3/13/09 [and s]he was

also treated with amoxicillin for [otitis media] on 3/2 for 7 days.” Id. Dr. Kimura characterized

A.F.’s rash as “the classic rash of systemic [Juvenile Idiopathic Arthritis (“sJIA”)] on her face,

arms and legs.” Id.5 The doctor’s “impression at that time was that [A.F.] most likely had

associated with symptoms including urticaria, erythema, arthopathy, arthritis, gastrointestinal

symptoms, and renal involvement.” Dorland’s Illustrated Medical Dictionary at 1557 (32nd ed.

2012) (hereinafter “Dorland’s”).

Petechia is “a pinpoint, nonraised, perfectly round, purplish red spot caused by intradermal or

submucous hemorrhage.” Dorland’s at 1422.

Purpura is defined as “any of a group of conditions characterized by ecchymoses or other small

hemorrhages in the skin, mucous membranes, or serosal surfaces; causes include blood disorders,

vascular abnormalities, and trauma.” Dorland’s at 1557.

Juvenile idiopathic arthritis is a type of “rheumatoid arthritis in children, [characterized by]

swelling, tenderness, and pain in one or more joints, which may lead to impaired growth and

development, limitation of movement, ankylosis, and flexion contractures.” Dorland’s at 150.

Systemic onset juvenile idiopathic arthritis is “a form of juvenile idiopathic arthritis

systemic JIA, but that she appeared to be improving without treatment.” Id. at 2. Accordingly,

Dr. Kimura asked A.F.’s mother “to keep a detailed fever and symptom diary,” id., and directed

her to give A.F. Motrin or Naprosyn if her fever or joint pain reappeared, id. at 9. A.F. went to a

follow-up appointment with Dr. Kimura two weeks later on April 28 and reported “only two

days of fever the previous week, and [that she] was otherwise OK except for some joint pain.”

Id. at 2.

For several weeks after that appointment, A.F.’s mother reported that A.F. “seemed to do

well except for [a] rash[, with] no fever or joint pain.” Id. The weekend of May 8, however, A.F.

had a severe flare up of her rash and joint pain and developed a high fever. Id. Dr. Kimura

prescribed naproxen, “which improved her symptoms.” Id.

Early in the week of May 18, A.F. “developed fever and rash at the time that one of her

siblings had strep, and Mrs. Faup started her on amoxicillin.” Id. A.F.’s mother characterized this

rash as a “strep rash” that was “different from the JIA rash.” Id. A.F. had lab work done on May

26, which “showed possible MAS (macrophage activation syndrome—a hemophagocytic

syndrome that can be life threatening in systemic JIA).” Id. Dr. Kimura reported that the “fever

and rash episode that she had early in the week may have been MAS.” Id. Dr. Kimura advised

petitioner that “MAS is a life threatening complication of [s]JIA that can flare at any time, and

that [A.F.] most likely needs steroids or a biologic agent that blocks IL-1, which has been shown

to be very effective in treating children with systemic JIA.” Id.

Immediately after A.F.’s alarming lab results came in on May 27, A.F.’s mother was

advised to take her daughter to the hospital to have the labs repeated immediately. Id. Although

A.F. had no symptoms at this time, with no fever, rash, or joint pain, A.F.’s mother took A.F. to

the Children’s Hospital of Philadelphia emergency department on May 28. Id.; Pet’r’s Ex. 12 at

1, ECF No. 8-12. Rheumatology assessed A.F.’s condition and concurred with the diagnosis of

sJIA. Pet’r’s Ex. 12 at 12. The repeated lab work “showed some improvement (from 5/27),” and

A.F.’s mother was asked to keep a close eye on A.F. and take her immediately to the emergency

room if her symptoms worsened. Pet’r’s Ex. 5 at 2.

On June 4, A.F. remained largely asymptomatic, but had a bone marrow evaluation done

to rule out leukemia or MAS. Pet’r’s Ex. 1 at 65. This test was “normal and showed no evidence

of either malignancy or MAS.” Id. A.F. attended a follow-up appointment with Dr. Kimura the

same day. Id. at 66. Dr. Kimura opined that A.F.’s MAS episode from May had “spontaneously

improved since she [was] asymptomatic at this time.” Pet’r’s Ex. 5 at 2. Dr. Kimura documented

that A.F. had swelling in both ankles, a rash, a low-grade fever, and “occas[ional] joint pain.”

Pet’r’s Ex. 1 at 66–67. Dr. Kimura assessed that A.F.’s sJIA was “still active” although her

“[status post] MAS [was] self controlled.” Id. at 67. On June 16, A.F. saw Dr. Kimura for “some

rash [and] occas[ional] joint pain,” although she had not had a fever since her last visit. Id. at 46.

A.F. began treatment with methotrexate, id., a drug “used as an antipsoriatic and antiarthritic in

the treatment of . . . severe rheumatoid and psoriatic arthritis,” Dorland’s at 1151.

accompanied by systemic manifestations such as spiking fever, transient rash on the trunk and

limbs, hepatosplenomegaly, generalized lymphadenopathy, and anemia.” Id. at 157.

On June 17, 2009, Petitioner took A.F. for an assessment by Dr. Thomas Lehman,

another pediatric rheumatologist. Pet’r’s Ex. 6 at 1–2. Although her symptoms had greatly

improved, Dr. Lehman found that A.F. “ha[d] clearly documented systemic-onset [juvenile

rheumatoid arthritis] by history and laboratory findings,” confirming her sJIA diagnosis by Dr.

Kimura. Id. at 2. 6

A.F. returned to see Dr. Kimura multiple times between July 14, 2009 and July 13, 2010.

Pet’r’s Ex. 1 at 43, 49, 52, 55, 58. Throughout this period, A.F.’s symptoms continued to

dramatically improve, until on July 13, 2010, A.F. reported no symptoms at all since her last

visit. Id. at 58. Around July 16 of 2009, Dr. Kimura advised Petitioner to stop the Naprosyn, and

around June 1, 2010, A.F. stopped taking the methotrexate without any resurgence in symptoms.

Id. at 44, 58–59. Although A.F.’s lab results continued to be abnormal, A.F. remained healthy

with no return of her sJIA symptoms. Pet’r’s Ex. 5 at 78–79; Pet’r’s Ex. 18 at 4, ECF No. 18-1.

II. Procedural Background

A. Pre-Hearing Proceedings Before the Special Master

On February 9, 2012, Petitioner filed a petition alleging that the vaccinations that A.F.

received on March 13, 2009 caused her to suffer “rheumatologic injury.” Pet. For Vaccine

Compensation at ¶¶ 1–2, ECF No. 1. In February and April of 2012, Petitioner submitted A.F.’s

medical records for consideration in connection with her petition. ECF Nos. 8, 10.

On June 18, 2012, the Secretary of Health and Human Services filed a Rule 4(c) Report,

recommending against compensation on the grounds that, in relevant part, Petitioner had failed

to proffer a medical theory causally linking A.F.’s injuries with the vaccines she received on

March 13, 2009. See Resp’t’s Rule 4(c) Report at 1, 14, ECF No. 12.

On September 12, 2013, Petitioner submitted an expert report prepared by Dr. Robert

Sundel, M.D., a pediatric rheumatologist, along with his curriculum vitae and supporting

literature. ECF No. 30. Petitioner submitted Dr. Sundel’s first supplemental expert report on June

15, 2015, ECF No. 44, and his second supplemental expert report on February 5, 2016, ECF No.

51. On February 13, 2017, Petitioner filed an expert report from Dr. Michael Gurish, a Ph.D. in

Experimental Pathology (Immunology). ECF No. 76.

The government submitted an expert report from Dr. Carlos Rose, M.D., C.I.P, a

pediatric rheumatologist, on January 13, 2014, along with his curriculum vitae and supporting

articles. ECF No. 32. On August 14, 2015, the government filed the first supplemental expert

report of Dr. Rose, along with expert reports from Dr. Edward W. Cetaruk, M.D., and Dr. J.

Lindsay Whitton, M.D., Ph.D. ECF No. 45. The government submitted Dr. Whitton’s first

supplemental expert report on August 4, 2016, ECF No. 60, and his second supplemental expert

report on May 30, 2017, ECF No. 86.

Systemic juvenile idiopathic arthritis (JIA) and systemic juvenile rheumatoid arthritis (JRA) are

the same condition. See Dorland’s at 157 (providing the same definition for JIA and JRA).

B. The Entitlement Hearing

An entitlement hearing was held in Washington, D.C. on March 13–14, 2018. ECF Nos.

114, 115. At the hearing, both parties presented the testimony of their experts, which is

summarized below.

1. Petitioner’s Experts 7

a. Opinion of Dr. Robert Sundel

i. Overview

Dr. Robert Sundel, a pediatric rheumatologist, submitted three expert reports in this case

and testified at the entitlement hearing. In his opinion, the DTaP and polio vaccines administered

on March 13, 2009 were the most likely cause of A.F.’s sJIA.

Although the pathogenesis of sJIA is unknown, Dr. Sundel postulated during his

testimony that its cause is likely “multifactorial,” Tr. 27:6–10, ECF Nos. 114, 115, involving “a

multitude of environmental, genetic and epigenetic factors,” Pet’r’s Ex. 24 at 3, ECF No. 51-1

(Second Supplemental Expert Report of Dr. Sundel). Dr. Sundel opined that A.F. developed sJIA

because of her “genetic susceptibility, [the] stimulation of [her] immune system, and the[

immunization which served as the] one final jerk to the immune system.” Tr. at 304:17–18,

303:16–20.

Dr. Sundel based his theory of causation on the “common understanding today [that s]JIA

is an innate immune system inflammatory disorder [(“autoinflammatory disease”)].” Id. at 37:8–

9. The innate immune system, Dr. Sundel testified, is the system’s first responder, id. at 28:6–8,

yet it is the “more primitive” arm of the immune system, id. at 28:17. “[I]t has the advantage of

working quickly and taking care of most of the major early pathogens.” Id. at 28:17–19. It does

so by “rapidly identify[ing] and destroy[ing]” invading organisms. Id. at 28:6–8. After the innate

immune system gets to work, Dr. Sundel explained, the adaptive arm of the immune system

takes over, which “changes its response depending on the exact invader, and also adjusts its

attack on the invader over time.” Id. at 28:9–11. Dr. Sundel explained that “innate [immune]

responses . . . , occur more rapidly than adaptive [immune] responses—minutes to hours rather

than . . . days to weeks.” Pet’r’s Ex. 24 at 2.

Implicated in the innate immune system, sJIA, and MAS, according to Dr. Sundel, are

monocytes, the cytokine 8 “IL-18,” and the cytokines “IL-1 and IL-6 . . . that cause fever and . . .

inflammation.” Tr. at 31:6–13. These “markers of the innate immune system are abnormal in

[s]JIA.” Id. at 31:6–16. Monocytes, he explained, “can become macrophages,” which in turn are

For a recitation of the qualifications of Petitioner’s and the government’s expert witnesses, see

Dec. at 7–16.

Cytokine is the “generic term for nonantibody proteins released by one cell population . . . on

contact with specific antigen, which act as intercellular mediators, as in the generation of an

immune response.” Dorland’s at 466.

primarily responsible for “releasing the cytokines in [MAS]” and are one component of the

body’s innate immune response. Id. at 31:24–32:21. “IL-18,” he further explained, “is the central

cytokine in the innate immune system,” id. at 40:3–5, and it is “much higher in [s]JIA and higher

still in [MAS]” than it is in other inflammatory diseases or infections, id. at 48:6–8. Thus, Dr.

Sundel testified, it is unsurprising that a “significant percentage” of patients with sJIA also suffer

from MAS, and “high levels [of IL-18] are predictive . . . of developing MAS.” Id. at 39:23–

40:8. MAS, Dr. Sundel explained, is a “cytokine storm . . . [,] where the innate immune system[]

and . . . the adaptive immune system[] are all triggered simultaneously.” Id. at 38:22–39:3. The

immune system is overwhelmed, he stated, which causes multiple dangerous symptoms,

including fever. Id. at 39:3–7, 39:19–22.

Autoinflammatory diseases, Dr. Sundel testified, are characterized by a dysregulation of

the innate immune system’s ability to respond, specifically “poor control of inflammation

[where] . . . the normal mechanisms by which the body [controls and prevents inflammation]

continually [do not] work.” Id. at 30:16–20. Therefore, Dr. Sundel concluded, “fever and rashes

and arthritis [occur] in children with systemic JIA, because their innate immune system is . . . out

of control.” Id. at 30:22–24.

Dr. Sundel explained that systemic JIA involves “systemic features of inflammation” in

addition to inflammation of the joints. Id. at 26:13–16. SJIA must be “diagnosed clinically” as its

cause is unknown, and it has “numerous manifestations that can differ from child to child.” Id. at

26:18–22. A.F.’s symptoms supportive of her sJIA diagnosis, Dr. Sundel testified, were her rash,

fever, arthritis, enlarged liver and spleen, and swollen lymph nodes. Id. at 26:24–27:5.

SJIA is triggered, according to Dr. Sundel, when a “genetically susceptible host[],”

Pet’r’s Ex. 20 at 2, ECF No. 30-1 (Expert Report of Dr. Sundel), 9 experiences “low-grade

inflammation that is controlled and then [some trigger] increases the amount of inflammation in

the child, the child is no longer able to maintain control of this low-grade inflammation and . . . it

explodes into a case of [s]JIA,” Tr. at 27:15–21.

Dr. Sundel’s theory is based at least partially on the fact that the DTaP vaccine contains

an aluminum adjuvant (“aluminum” or “alum”). See id. at 45:4–5. 10 Adjuvants, Dr. Sundel

testified, are intentionally designed to “stimulate[]” the innate immune response. Id. at 34:24–25.

Dr. Sundel posited that adjuvants “activate[] the inflammasomes, which are the control center[s]

of the innate immune system, causing release of [the] IL-18 [cytokine], and trigger[ing] . . .

inflammation . . . in the innate immune system.” Id. at 34:24–35:4. Dr. Sundel also explained

that the innate immune system “is built to recognize” another primary component of a vaccine,

the antigen, so that the immune system launches “a speedy attack . . . mediated by the innate

For Pet’r’s Ex. 20, the Court uses the pagination of the PDF document from the CM-ECF

system.

An adjuvant is defined as “a substance that aids another,” or, “in immunology, a nonspecific

stimulator of the immune response, such as BCG vaccine.” Dorland’s at 32. More specifically,

Dr. Sundel explained that “[a]djuvants, particularly aluminum[,] . . . are additives used to

increase the immunologic response to vaccines.” Pet’r’s Ex. 24 at 4.

immune system.” Id. at 34:2–7.11 But while he concluded that A.F.’s sJIA “could[ not] have

happened without the vaccine,” id. at 88:6–8, he stated that there was not “enough data” to

pinpoint specifically which part of the vaccine (i.e., the adjuvants or the antigen) caused her

sJIA, id. at 87:24–25, and he did not know “[w]hether it was essential to have all aspects of the

. . . vaccine,” id. at 310:19–21.

ii. Dr. Sundel’s Discussion of “ASIA”

Of significance to the issues raised in the motion for review, Dr. Sundel’s expert reports

also contained references to research concerning what has been characterized as the

“Autoimmune (auto-inflammatory) Syndrome Induced by Adjuvants” (also known as “ASIA”).

See Pet’r’s Ex. 23 at 3–4, ECF No. 44-1 (First Supplemental Report of Dr. Sundel). 12 The

existence of that syndrome was first proposed in an article published in 2011 in the Journal of

Autoimmunity. See Pet’r’s Ex. 23, Tab D (Yehuda Shoenfeld & Nancy Agmon-Levin, ‘ASIA’ –

Autoimmune/inflammatory syndrome induced by adjuvants, 36 J. Autoimm. 4 (2011)

(hereinafter the “Shoenfeld article”). The article’s authors, Drs. Shoenfeld and Agmon-Levin,

hypothesized that a “genetically susceptible subject may develop an autoimmune or auto-

inflammatory disease . . . following exposure” to an “adjuvant.” Id. at 37. They also posited that

“in rare occasions, . . . vaccines can induce . . . enigmatic inflammatory condition and overt

autoimmune disease . . . weeks and even months or years following vaccination.” Id. at 38. Drs.

Shoenfeld and Agmon-Levin recommended that four different medical conditions that “share

clinical and pathogenic resemblances . . . be included under a common syndrome entitled the

‘Autoimmune (Auto-Inflammatory Syndrome Induced by Adjuvants’ (ASIA).” Id. at 40. These

allegedly related medical conditions included siliconosis, Gulf War syndrome, macrophagic

myofascitis syndrome, and a variety of “post-vaccination phenomena.” Id. at 37. The article

proposed several major and minor criteria that would justify an ASIA diagnosis. Id. at 40.

In his first supplemental expert report, Dr. Sundel included several references to the

ASIA theory, observing that it has “raised the possibility that triggering of arthritis and other

forms of autoimmunity may be the result of immune potentiation by additives to immunizations

rather than the vaccines themselves.” Pet’r’s Ex. 23 at 4 (citing Pet’r’s Ex. 23, Tab D (Shoenfeld

article)). He also wrote that A.F.’s “arthritis is consistent with the . . . rapid response that may

occur when [an] adjuvant triggers pathologic inflammation,” and that the “[d]ata supporting such

a mechanism in the pathogenesis of post-vaccination phenomena” was summarized in the

Shoenfeld article. Id. at 4. Dr. Sundel also cited an article, which attempted to test the ASIA

hypothesis, as “support[ing] a role of aluminum adjuvants particularly in young girls who

develop arthritis shortly after an immunization.” Id. at 5 (citing Pet’r’s Ex. 23, Tab L (Sergio

An antigen is “any substance capable, under appropriate conditions, of inducing a specific

immune response and of reacting with the products of that response . . . [and] may be soluble

substances, such as toxins and foreign proteins, or particulate, such as bacteria and tissue cells.”

Dorland’s at 103.

For Pet’r’s Ex. 23, the Court uses the pagination of the PDF document from the CM-ECF

system.

Cerpa-Cruz et al., Adverse Events Following Immunization with Vaccines Containing

Adjuvants, 56 Immunol. Research 299 (2013)).

Dr. Sundel did not bring up the ASIA theory in his direct testimony, but it was raised by

counsel for the government in her cross-examination. In response to her questions, he

characterized ASIA as “an overly broad generalization of what happens with vaccines.” Tr. at

72:5–6. Nonetheless, he stated that the ASIA theory had value because it showed “[t]hat we had

not been paying enough attention to what the adjuvants do, and we had not been considering

possible adverse effects.” Id. at 74:9–11. “[T]hroughout history,” he continued, “vaccines have

had both good and bad effects, and the relative number of good and bad effects vary, and over

time, the claims that certain good or bad effects are caused by the vaccines are proven or

disproven by scientists.” Id. at 74:11–16. He stated that while the Shoenfeld article was “not

proof,” it provided “a reasonable hypothesis that in some patients [adjuvants have] an adverse

effect.” Id. at 83:9–11.

The Special Master also questioned Dr. Sundel regarding his understanding of ASIA. He

characterized ASIA as “a general theory that there can be adverse effects from the effects of

adjuvants on people, basically, very broadly,” and observed that it was “too broad for a theory

that will have any use in clinical medicine, or even in the legal system.” Id. at 84:18–22. Upon

further questioning by the Special Master, he also stated that another difference between his

theory and ASIA is that he was unsure whether it was the adjuvant, an antigen, or a combination

that caused A.F.’s sJIA. Id. at 88:10–13. He stated that “[i]t couldn’t have happened without the

vaccine,” although he really did not know “was it the IP [vaccine], was it the DTaP, was it

alum?” “[B]ut,” he said, “I do know that the combination was not good for her.” Id. at 88:5–9.

b. Opinion of Dr. Michael Gurish

Dr. Michael Gurish, a Ph.D. in Experimental Pathology (Immunology), submitted one

expert report and testified at the entitlement hearing. Dec. at 10. 13 Dr. Gurish agreed with Dr.

Sundel that “[t]here is good reason to believe the adjuvanted Diphtheria and Tetanus vaccine

induced or provoked the inflammatory response that led to the appearance of [A.F.’s] sJIA.”

Pet’r’s Ex. 29 at 1, ECF No. 76-1 (Expert Report of Dr. Gurish).

At the entitlement hearing, Dr. Gurish began his testimony by explaining, as had Dr.

Sundel, that “the immune system [is] divided into the innate versus the adaptive immune

system.” Tr. at 96:23–24. Dr. Gurish described the innate immune system as “the first to be

activated” in an immune response, id. at. 97:16–18, “which then stimulates the adaptive immune

system . . . by presenting components (antigens) of the pathogens . . . and by their secretion of

mediators (cytokines),” Pet’r’s Ex. 29 at 2. In his expert report, Dr. Gurish observed that sJIA is

an “autoinflammatory reaction,” meaning that it “principally involves innate cells, such as

Dr. Gurish is also an associate immunochemist at Brigham and Women’s Hospital in Boston,

and an associate professor of medicine at Harvard Medical School. Dec. at 10. The Special

Master noted that Petitioner “did not move to admit Dr. Gurish as an expert in the field of

immunology,” but that “he provided opinion testimony in that area.” Id. at 11.

macrophages.” Id. In A.F.’s case, Dr. Gurish wrote, “it appears that [her] innate immunity was

over stimulated and uncontrolled because [A.F. also] experienced [MAS].” Id. at 3.

Dr. Gurish testified that—in combination with a number of other factors, such as A.F.’s

previous ear infection and recent treatment with antibiotics—the alum from the vaccine

“stimulate[d A.F.’s] immune system” and set off a chain of internal immune responses that led to

the “robust innate activation” that ultimately triggered A.F.’s sJIA. Tr. at 114:24–115:4. Dr.

Gurish explained that “alum . . . forms a complex” that “activates the macrophage and induces

the formation of inflammasomes.” Id. at 105:14–16, 105:24–106:2. In turn, “the formation of the

inflammasome” produces “cytokines,” such as “IL-1 and IL-18.” Id. at 106:6–15. The

“subsequent elaboration of cytokines such as IL-1 and IL-6,” Dr. Gurish wrote in explanation,

are “two of the most important mediators of sJIA.” Pet’r’s Ex. 29 at 4.

2. The Government’s Experts

a. Opinion of Dr. Carlos Rose

Dr. Carlos Rose, a pediatric rheumatologist, submitted two expert reports and testified at

the entitlement hearing, where he evaluated and criticized Petitioner’s vaccine-induced theory of

causation and posited an alternative theory of viral causation to explain why A.F. developed

sJIA. Dr. Rose agreed with Petitioner’s experts on a number of points relating to sJIA’s

characterization as an autoinflammatory disease and the immunologic effects of adjuvants on the

body. But he concluded that—contrary to Petitioner’s experts—the vaccine played no role in the

onset of A.F.’s sJIA. Tr. at 141:19–22. Rather, he opined that the cause was more likely viral in

origin, encompassing both the viral ear infection that preceded the vaccination and a possible

exposure to an undiagnosed viral infection “between vaccin[ation] and [the] onset of [her s]JIA.”

Resp’t’s Ex. G at 2, ECF No. 45-1 (First Supplemental Expert Report of Dr. Rose). Dr. Rose

reasoned that if the vaccines had caused “a clinical and relevant activation of the innate immune

system,” then he thought A.F. should have had “at least some fever . . . within . . . 24 or 48

hours” after she was vaccinated. Tr. at 160:1–6.

b. Opinion of Dr. James Whitton

Dr. James Whitton, an immunologist, submitted three expert reports and testified at the

entitlement hearing. In his first supplemental expert report, Dr. Whitton proposed that A.F.’s

sJIA was triggered by her previous ear infection, whose “[b]acterial DNA is a strong stimulator

of the innate immune response.” Resp’t’s Ex. J at 11, ECF No. 60-1 (First Supplemental Expert

Report of Dr. Whitton). He also “note[d] with interest Dr. Rose’s contention that the purpuric

rash that she displayed early in the course of disease might have been reflective of an

undiagnosed viral infection.” Id.

Like Dr. Rose, Dr. Whitton agreed with Petitioner’s experts overview of the basic

mechanics of aluminum’s activation of the innate immune system, Tr. at 201:14–17, and sJIA’s

characterization as an autoinflammatory disease, id. at 238:1–3, 15–18. But the fact that “alum

will be taken up by macrophages and cause a local inflammatory response,” Dr. Whitton warned,

should not be “conflate[d]” with the notion that this can “cause an autoimmune disease.” Id. at

260:1–13. He disagreed with Petitioner’s theory of vaccine-induced causation based primarily on

his opinion that the triggering of the innate immune system that results from alum, including the

production of cytokines, is of limited duration, id. at 201:17–202:4, occurring “usually within the

first 24 to 48 hours and [then] dissipat[ing] fairly rapidly thereafter,” id. at 202:15–20. In Dr.

Whitton’s view, an “ongoing driver” of inflammation is required to “drive a serious

autoinflammatory disease,” and the relatively short-lived activation of the innate immune system

that occurs in response to an alum adjuvant does not provide such a driver. Resp’t’s Ex. J at 8–9

(internal quotation marks omitted).

C. The Special Master’s Decision

Following the hearing, the parties submitted post-hearing briefs. ECF Nos. 116, 118, 119.

On June 17, 2019, the Special Master issued a decision ruling that A.F. was not entitled to

compensation under the Vaccine Act because Petitioner failed to show that A.F.’s condition was

caused by the vaccines. ECF No. 120.

1. Credibility of Petitioner’s Experts

The Special Master began her analysis with a general critique of the credibility of

Petitioner’s experts, Drs. Sundel and Gurish. She acknowledged Dr. Sundel’s “impressive

credentials” and his extensive experience treating sJIA patients but found that his expertise “was

undercut” by what she characterized as “a vague and inconsistent causation theory.” Dec. at 28.

Among other things, she found it significant that despite his “clear assertion that sJIA is an

autoimmune syndrome induced by adjuvants,” Dr. Sundel had “not refer[red] to his theory by the

ASIA acronym well known in the [Vaccine] program.” Id. 14

The Special Master acknowledged that Dr. Sundel had disavowed reliance on the ASIA

theory during his testimony, and that he had stated that, in his view, ASIA is “too broad for a

theory that will have any use in clinical medicine, or even in the legal system.” See id. at 28

(quoting Tr. at 84:20–22). But the Special Master considered his “rejection of ASIA . . .

contradicted by his filed medical literature,” in particular by: 1) his citation of the Cerpa‐Cruz

article, supra, as his “best evidence that aluminum salt adjuvant can trigger pathologic

inflammation or another adverse event,” and 2) the citation of the Shoenfeld article in his expert

report and his statements under questioning by the Special Master in which he “praised Dr.

Shoenfeld’s work while acknowledging that it needs to be understood better,” and “conceded”

that the 2011 article “is not proof,” id. (internal quotation marks and citations omitted).

“For many of the same reasons,” the Special Master also found Dr. Gurish unpersuasive.

Id. at 29. Specifically, she observed that Dr. Gurish—who, like Dr. Sundel, had disavowed

reliance upon ASIA as the basis for his theory of causation—had failed to “explain how he had

The Special Master’s reference to ASIA as being “well-known” in the vaccine program is

based on several decisions that she discussed subsequently in her opinion, in which, she stated,

its validity was “called into doubt.” Dec. at 29.

narrowed Dr. Shoenfeld’s ASIA theory”; nor had he “explained away holes in the [ASIA]

causation theory that relate to its vague symptoms or unspecified triggers.” Id. at 28–29.15

2. Althen Prong One

The Special Master then analyzed whether Petitioner had met her burden to prove by a

preponderance of the evidence that the vaccine caused her injury using the three-prong test set

forth in Althen v. Secretary of Health and Human Services. 418 F.3d 1274 (Fed. Cir. 2005).

Turning to Althen prong one, the Special Master concluded that Petitioner “failed to prove by a

preponderance of the evidence her theory causally connecting A.F.’s DTaP and IP vaccinations

to her sJIA.” Dec. at 29. She noted that Dr. Sundel’s theory was constructed on the basis of

sJIA’s characterization as an autoinflammatory disease, “the general principles of the innate

immune system, and the accepted premise that the DTaP and IP vaccines are designed to elicit an

immune response.” Id.

The Special Master stated that Petitioner’s medical theory “can best be summed up by

Dr. Sundel’s assertion, “was it the IP[vaccine], was it the DTap, was it alum? I don’t really

know, but I know that the combination was not good for her.” Id. at 29 (citing Tr. at 88:5–9)

(testimony of Dr. Sundel). She observed again that despite Dr. Sundel’s critique of the ASIA

theory, his “stated theory is based on the role of adjuvants in the development of adverse events.”

Id. Therefore, she stated, “[Dr. Sundel’s theory] is ASIA and it fails now for the same reasons it

has previously failed: the diagnostic criteria proposed by the ASIA study’s authors are both

vague and flawed.” Id.

Drs. Sundel and Gurish’s reports, she noted, “do not add precision to the ASIA criteria,

elaborate on the role of aluminum or specify how much is needed, provide any further support

from scientific or medical experts in the field, or add any additional evidence to support the

theory.” Id. at 30. In her view, Petitioner’s experts merely “repeat[ed] what has already been

rejected” in previous cases repudiating ASIA. Id. In short, the Special Master concluded,

Petitioner “failed to provide a reputable medical theory” sufficient to prove Althen prong one

because “she is unable to distinguish [her theory] from ASIA” and has “failed to present any new

evidence to overcome” the “previously identified shortcomings” of ASIA. Id. at 31.

3. Althen Prong Two

The Special Master then turned to Althen prong two, which requires a petitioner to

demonstrate a logical sequence of cause and effect showing the vaccination caused the injury.

Id. at 32. According to the Special Master, Dr. Sundel’s conclusion that A.F.’s sJIA was vaccine

induced was grounded in the short period of time between vaccination and the onset of A.F.’s

symptoms and on “the absence of alternative explanations” for her sJIA. Id. (quoting Pet’r’s Ex.

Dr. Gurish testified that he would “echo Dr. Sundel’s opinion that while the ASIA hypothesis

is intriguing in the sense that someone is trying to understand these adverse events on a very

global scale,” the ASIA hypothesis is “also is disruptive in the sense, for me as a scientist, it’s

hard to make predictions based on this global hypothesis . . . , and I want testable hypotheses to

test, to try to prove whether there is a cause-and-effect relationship.” Tr. at 127:24–128:7.

20 at 2). She noted, however, that “Petitioner’s theory does not explain the roles any of the non-

adjuvanted vaccines played in the development of A.F.’s sJIA,” and that Petitioner’s experts did

not say which vaccines were necessary to cause A.F. to manifest symptoms. Id.

The Special Master asserted that Dr. Gurish had stated in his report that the symptoms

A.F. experienced “two to four days after vaccination . . . match both the ASIA criteria and data

from several studies.” Id. (citing Pet’r’s Ex. 29 at 5). She observed that “ASIA’s diagnostic

criteria are unclear” and concluded that “Petitioner has failed to provide preponderant evidence

establishing that ASIA (or the ASIA-like theory proposed by Dr. Sundel) can be applied to any

specific case generally, or A.F.’s specifically.” Id. at 32–33.

The Special Master also found unavailing Dr. Sundel’s testimony that A.F.’s sJIA was

caused by a “confluence of events,” including “her genetic predisposition and a variety of

environmental factors.” Id. at 33. She found more persuasive the alternative theory of causation

proposed by the government’s experts—that A.F.’s sJIA was triggered by a viral infection. Id.

She cited their testimony that the effects of the small amount of aluminum contained in the

vaccines are both localized and short lived and therefore “A.F.’s sJIA could not have been

caused by her vaccines.” Id. (citing Resp’t’s Ex. A at 7–8, ECF No. 32-1 (Expert Report of Dr.

Rose); Resp’t’s Ex. J at 11–12). Further, she observed, they had opined that “A.F.’s genetic

predisposition and MAS, which are both commonly triggered by viral infections, support the

need for an ‘ongoing driver’ that gives rise to sJIA.” Id. In addition, she noted that the

government’s experts had “also explained that because of A.F.’s genetic predisposition to sJIA—

which is linked to the innate immune system via the cytolysis pathway—a similar MAS-like or

JIA-like response would have occurred after every vaccination with an aluminum adjuvant.” Id.

As this did not occur, the Special Master found it “more likely that a viral infection triggered

A.F.’s sJIA.” Id.

The Special Master also found credible Dr. Rose’s explanation that since A.F.’s lab

results did not support the existence of MAS on March 27, 2009, the more likely explanation for

A.F.’s purpuric rash was a viral infection. Id. And, the Special Master found, “[g]iven A.F.’s

genetic predisposition and the symptoms she exhibited at the time, it is more likely that this viral

infection was the substantial factor that triggered her sJIA than the vaccines in question.” Id.

4. Althen Prong Three

Turning to prong three of the Althen test, which requires a petitioner to show a proximate

temporal relationship between vaccination and injury, the Special Master observed that the

parties disagreed on whether A.F.’s sJIA developed in mid-to-late March, i.e., within days after

she was vaccinated on March 13, 2009, or whether its onset occurred weeks later, in early April

2009. Id. at 34. Dr. Sundel’s “proposed time frame for disease onset was four to five days post

vaccination,” the Special Master wrote, which he based on A.F.’s medical records and her

ultimate diagnosis of sJIA. Id. (citing Tr. at 19:13–17). According to the Special Master, this

theory was based on “circular reasoning.” Id. In her view, Dr. Sundel had posited “that because

A.F.’s injury is vaccine induced, the onset of A.F.’s symptoms establishes the appropriate time

frame for a vaccine-related injury.” Id.

The Special Master observed, however, that the government’s expert, Dr. Rose, did not

believe that the purpuric rash A.F. had on March 27 was a symptom of sJIA, and that he had

found that she did not have diagnosable MAS at that time. Id. Dr. Rose concluded on the basis of

lab results that A.F.’s initial rash was caused by a viral infection, “which would place the onset

for sJIA, weeks later, in early April 2009.” Id. The Special Master found that “based on the

preponderant standard, A.F.’s sJIA was more likely caused by a viral infection [and t]he time

frame proposed by Dr. Rose is therefore more appropriate.” Id.

The Special Master explained that neither party had offered medical literature that

discussed an appropriate time frame for vaccine-induced sJIA. Id. It was therefore “[t]he broader

deficiencies with Petitioner’s theory (which did not otherwise establish that the DTaP and IP

vaccines could cause sJIA) [that] render[ed her] unable to find that the timing at issue in this case

of the alleged vaccine-induced sJIA has been shown to be medically acceptable.” Id.

D. The Present Motion for Review

Petitioner filed her motion for review of the Special Master’s Decision with this Court on

July 17, 2019. Petitioner’s Mot. for Review (“Pet’r’s Mot.”), ECF No. 121. In her motion,

Petitioner argues that the Special Master “improperly heightened” her burden of proof, “and

failed to consider the record as a whole.” Id. at 13. Specifically, according to Petitioner, the

Special Master required Petitioner to prove what she characterizes as a new “nebulous” theory,

known as ASIA, that links adjuvanted vaccines to autoinflammatory diseases. Id. She also

contends that the Special Master required “proof of the exact amount of the aluminum adjuvant

needed to cause [s]JIA.” Id. at 23. Finally, Petitioner argues that the Special Master committed

legal error by requiring greater evidence from Petitioner than that articulated in Althen prong

three, and that the Special Master failed to consider the record as a whole in denying entitlement

based on the government’s alternative theory of viral causation, which Petitioner contends is not

supported by the evidence. Id. at 25–26.

The government filed its response to Petitioner’s motion on August 16, 2019. Resp’t’s

Mem. in Resp. to Pet’r’s Mot. for Review, ECF No. 125. It argues that the Special Master

properly identified and applied the legal standard, that Petitioner failed to establish a logical

sequence of causation between the vaccines and the onset of A.F.’s injury, and that Petitioner did

not establish that the timing between vaccination and the onset of her sJIA was medically

appropriate. Id. at 9, 15, 17.

Oral argument was held on December 4, 2019. See ECF No. 127.

DISCUSSION

I. Jurisdiction and Standard of Review

Congress established the National Vaccine Injury Compensation Program in 1986 to

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

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

remedial legislation that should be construed in a manner effectuating its underlying spirit and

purpose. Id.

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

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

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

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

under the [Vaccine Act] Program and the amount of such compensation.” Id.

§ 300aa-12(d)(3)(A).

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

the proceedings before a special master, and authority, upon such review, to:

1) Uphold the findings of fact and conclusions of law of the special master and

sustain the special master’s decision;

2) Set aside any findings of fact or conclusion of law of the special master found to

be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue

its own findings of fact and conclusions of law; or

3) Remand the petition to the special master for further action in accordance with the

Court’s direction. Id. § 300aa-12(e); see also Vaccine Rule 27.

On review of the special master’s decision, the Court applies the arbitrary and capricious

standard to factual findings and the “not in accordance with law” standard to legal rulings.

Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir.

2010). The Court’s scope of review is a narrow one. The Court “do[es] not reweigh the factual

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

probative value of the evidence or the credibility of the witnesses,” because those “are all matters

within the purview of the fact finder.” Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242,

1249 (Fed. Cir. 2011) (citing Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339,

1345 (Fed. Cir. 2010)). “[A]s long as a special master’s finding . . . is ‘based on evidence in the

record that [is] not wholly implausible,’” the Court must uphold it. Id. (quoting Cedillo v. Sec’y

of Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010) (alteration in original)).

“‘[T]he standard of review is uniquely deferential’” to a special master’s decisions. Milik v.

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

Sec’y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). If a special master “‘has

considered the relevant evidence of record, drawn plausible inferences and articulated a rational

basis for the decision,’ then reversible error is ‘extremely difficult to demonstrate.’” Milik, 822

F.3d at 1376 (quoting Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir.

1991)).

II. Petitioner’s Burden of Proving Causation

To secure compensation under the Vaccine Act, a petitioner must prove by a

preponderance of the evidence that the injury at issue was caused by a vaccine. See 42 U.S.C.

§§ 300aa-11(c)(1), -13(a)(1). Where a petitioner sustains an injury in association with a vaccine

listed in the Vaccine Injury Table, causation is presumed. Broekelschen, 618 F.3d at 1341–42

(citing 42 U.S.C. § 300aa-11(c)(1)(C)(i)); Andreu v. Sec’y of Health & Human Servs., 569 F.3d

1367, 1374 (Fed. Cir. 2009)). Where, as in this case, the injury is not listed in the Table, the

petitioner must prove causation in fact. Broekelschen, 618 F.3d at 1342 (citing Moberly, 592

F.3d at 1321). To discharge that burden, “a petitioner must show that the vaccine was not only a

but-for cause of the injury but also a substantial factor in bringing about the injury.” Stone v.

Sec’y of Health & Human Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012) (quotations omitted).

“Once the petitioner has demonstrated causation, she is entitled to compensation unless the

government can show by a preponderance of the evidence that the injury is due to factors

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

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

The three-pronged test that the Federal Circuit announced in Althen v. Sec’y of Health &

Human Servs., 418 F.3d 1274 (Fed. Cir. 2005), guides the causation determination. Under that

test, to make a prima facie case that a vaccination caused the petitioner’s injury, he or she must

provide: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical

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

showing of a proximate temporal relationship between vaccination and injury.” Id. at 1278. If

Petitioner makes her prima facie case under Althen, the burden of proof shifts to the government

“to establish that [a] factor unrelated to the vaccination is the more likely or principal cause of

the injury alleged.” Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d

1363, 1369 (Fed. Cir. 2013).

III. Merits of the Motion for Review

In this case, Petitioner argues that the Special Master “improperly heightened” her burden

of proving causation. Pet’r’s Mot. at 13. Specifically, she contends that the Special Master

faulted her for failing to address and resolve the apparent flaws of the ASIA theory,

notwithstanding that her experts articulated a narrower theory of causation specific to A.F. Id.

She further contends that the Special Master failed to consider the record as a whole and instead

premised her denial of entitlement “on the Petitioner’s failure to prove a different and much

larger theory”—i.e. ASIA. Id. at 22.

For the reasons set forth below, the Court agrees with Petitioner that the Special Master’s

decision includes passages in which she appears to have conflated Petitioner’s specific theory of

causation with the more generic “ASIA theory,” which prior decisions under the Vaccine Act

have found too vague and overbroad to support a causal relationship between vaccines and

autoimmune or autoinflammatory diseases. See Dec. at 29–30 (listing cases). Nonetheless, the

Court concludes that the error was a harmless one because, as explained below, the Special

Master’s decision reflects that she also found that Petitioner failed to show by preponderant

evidence that the specific theory of causation her experts articulated satisfied prongs one and/or

two of the Althen test. Because those findings are “based on evidence in the record that [is] not

wholly implausible,” they must be affirmed. See Porter, 663 F.3d at 1249.16

Because the Court sustains the Special Master’s findings regarding Althen prongs one and

two, it does not address Petitioner’s claims regarding the Special Master’s analysis under prong

three.

A. The Special Master’s Decision Reflects Some Conflation of Petitioner’s Specific

Theory of Causation with the More Generic ASIA Theory

As the Special Master observed, to satisfy prong one of the Althen test, Petitioner was

required to set forth a medical theory explaining how the vaccines A.F. received could have

caused her injury. Dec. at 26–27. (citing Pafford v. Sec’y of Health & Human Servs., No. 01-

01765V, 2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004) aff’d sub nom. Pafford ex

rel. Pafford v. Sec’y of Health & Human Servs., 64 Fed. Cl. 19 (2005), and aff’d sub nom.

Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352 (Fed. Cir. 2006)) (noting that prong

one addresses whether the vaccine at issue can cause the type of injury alleged). To pass muster,

the theory had to be more than merely “plausible” or “possible.” Boatmon v. Sec’y Health &

Human Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019). Instead it was required to be both “sound

and reliable,” Knudsen ex rel. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548

(Fed. Cir. 1994), and to rise to the level of more probable than not, Moberly, 592 F.3d at 1322;