Fisher v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 18-1705V

Filed: May 30, 2024

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JUSTIN FISHER, on behalf of A.F., *

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Petitioner, *

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v. *

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SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

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Respondent. *

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Mark Sadaka, Law Offices of Sadaka Associates, LLC, Englewood, N.J., for Petitioner

Voris Johnson, U.S. Department of Justice, Washington, DC, for Respondent

DECISION ON ENTITLEMENT1

Oler, Special Master:

On November 2, 2018, Justin Fisher (“Petitioner” or “Mr. Fisher”) filed a petition for

compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10,

et seq.2 (the “Vaccine Act” or “Program”) on behalf of his minor daughter, A.F. The petition

alleges that A.F. developed acute disseminated encephalomyelitis (“ADEM”) that was either

caused-in-fact or significantly aggravated by one or more of the vaccines she received on

November 3, 2015. Pet. at 1, ECF No. 1.

1

Because this Decision contains a reasoned explanation for the action 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 Decision 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

National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease

of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa

(2012).

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Upon review of the evidence in this case, I find that Petitioner has not established by

preponderant evidence that the vaccines A.F. received caused her condition. The petition is

accordingly dismissed.

I. Procedural History

Mr. Fisher filed his petition on November 2, 2018. Pet. at 1. He filed medical records (Exs.

1-8) followed by a statement of completion on February 21, 2019. ECF No. 12.3 Respondent

submitted his Rule 4(c) Report on June 13, 2019, stating that “petitioner is not entitled to

compensation under the terms of the Act.” Resp’t’s Rep. at 2, ECF No. 15.

Respondent identified several missing medical records and requested that Petitioner file

those documents. ECF No. 16. Petitioner filed additional medical records on August 20, 2019 and

December 16, 2019. Exs. 9-12.

The parties then filed expert reports in support of their respective positions. (Ex. 13, Expert

Report from Dr. David Younger; Exs. A and C, Responsive Expert Reports from Dr. Gregory

Holmes and Dr. You-Wen He).

After these filings, I requested additional information from the parties. As a result, they

submitted additional expert reports. (Ex. E, Expert Report from Dr. Holmes, Ex. 22, Expert Report

from Dr. Alberto Martinez-Arizala, Ex. F, Responsive Expert Report from Dr. Holmes).

Subsequent to these filings, I conducted a Rule 5 Conference where I tentatively found that A.F.’s

ADEM was more likely caused by her preceding viral infection than by the November 3, 2015

vaccinations. ECF No. 55. I suggested that Petitioner’s counsel speak with Mr. Fisher about

dismissing his petition. I gave counsel 30 days to discuss my preliminary findings with his client

and then submit a status report. Id.

On May 10, 2022, Petitioner filed a status report requesting a decision on the evidentiary

record. ECF No. 59. I set a briefing schedule based on this request. See Scheduling Order dated

May 11, 2022. However, on August 8, 2022, Petitioner filed a status report contending that A.F.

displayed indications of encephalopathy with no documented signs of infection. Petitioner asked,

“Does the Court want to hear from the petitioner’s expert on this matter?” ECF No. 63 at 3. I

granted the parties additional time to file expert reports on this issue. Petitioner filed an expert

report from Dr. Martinez-Arizala. Ex. 41. Respondent elected not to respond and instead filed a

Motion for a Ruling on the Record. ECF No. 68. Petitioner responded, and both parties filed

3

On November 19, 2018, Petitioner filed an amended petition which alleged that A.F. additionally suffered

an intussusception as a consequence of the vaccines she received on November 3, 2015. Amended Pet. at

1. ECF No. 9. During a status conference on August 1, 2019, I informed the parties that it appeared from

my review of the medical records that A.F. did not experience six months of sequela following her

intussusception. Subsequent to that, none of Petitioner’s experts have opined in support of an

intussusception claim, and Petitioner did not brief that A.F. suffered from intussusception in his Response

to the Motion for a Ruling on the Record or in his Sur-Reply. Accordingly, I have not analyzed this issue.

2

A.F. returned to Dr. Ram on August 7, 2015 for continued fussiness. Ex. 2 at 54-55. A.F.’s

mother reported that the fussiness was not worse but had not improved with Zantac, gripe water,

or gas drops. Id. at 54. A.F.’s mother reported that A.F. was feeding well but would become fussy

15-20 minutes after and was spitting up a lot. Id. Dr. Ram noted that A.F.’s weight gain was

adequate but lower than expected. Id. at 55. Dr. Ram prescribed Prevacid5 and recommended that

A.F.’s mother try to avoid milk and soy. Id. Dr. Ram also recommended supplementation with

Alimentum to ensure A.F. was eating enough.

On August 14, 2015, A.F. visited Dr. Daniel O’Connell, a pediatric gastroenterologist, at

the American Family Children’s Hospital, with a chief complaint of fussiness, with possible reflux

or milk protein intolerance. Ex. 4 at 5-7. Dr. O’Connell noted that A.F.’s mother was one week

into a milk/soy elimination diet but he would expect results in two weeks in A.F. Id. at 7. He was

not concerned as A.F. was gaining weight consistently and expressed that it was “difficult to

determine exactly what is causing her to cry – protein intolerance, colic, gas, or other non-GI

problems, but in general I am reassured by her growth and development so far.” Id.

On August 28, 2015, A.F returned to Dr. Ram at Meriter Hospital. Ex. 2 at 63-64. A.F.’s

parents reported that A.F.’s fussiness was improving. Id. Dr. Ram recommended that A.F.’s

mother continue the current plan of the elimination diet and supplementation with Alimentum. Id.

Dr. Ram recommended genetic testing for ankylosing spondylitis and provided a referral to a

pediatric ophthalmologist. Id. at 64.

On September 8, 2015, A.F. had her two month well-child visit. Ex. 2 at 72-75. A.F.’s

mother reported that A.F. experienced more gas during feedings. Id. at 72. A.F. had normal growth

and development. Id. at 73. A.F. experienced improvement with Prevacid. Id. at 74-75, 80. A.F

received her scheduled vaccines. Id. at 75.

On October 8, 2014, A.F. visited the pediatric after-hours clinic at Meriter Hospital. Ex. 2

at 85-87. A.F. had fallen off a couch while her mother’s head was turned. Id. at 85. A.F was found

lying on her back still crying with spit up. Id. A.F. had a history of GERD but no vomiting. Id.

A.F. was not injured and was released with a recommendation to take acetaminophen as needed

for fever or pain. Id. at 86.

On October 22, 2014, A.F. returned to the Meriter Pediatric After Hours Clinic, because

she had been screaming inconsolably for the last few hours. Ex. 2 at 100-03. A.F’s fussiness

resolved during this visit. Id. at 101. A.F.’s mother was concerned about an ear infection because

MEDICAL DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=102068 (last

accessed on May 9, 2024) (“DORLAND’S”).

5

Prevacid: trademark for a preparation of lansoprazole. DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=27578 (last accessed on May 9, 2024);

Lansoprazole: a substituted benzimidazole that acts as a proton pump inhibitor; used to inhibit the secretion

of gastric acid for the symptomatic treatment of duodenal and gastric ulcers and gastroesophageal reflux

disease and for the long-term treatment of hyperchlorhydria; administered orally. DORLAND’S,

https://www.dorlandsonline.com/dorland/definition?id=27578 (last accessed on May 9, 2024).

4

she had started daycare and had been tugging at her right ear. Id. A.F. was negative for redness,

swelling, and fever. Id.

A.F. presented for her four-month wellness visit on November 3, 2015. Ex. 2 at 105-13.

During this visit, the medical record notes that she was congested, and that over the past two days

she had been spitting up more than normal and her stools had been green in color. Id. at 110. She

did not have a fever and was noted to be feeding well. Id. A.F. was diagnosed with a viral illness,

reflux, and milk protein intolerance. Id. at 112. She received the allegedly causal DTaP, Hep B,

IPV, Hib, rotavirus, and PCV vaccinations during this visit. Id.

On November 24, 2015, A.F. visited Dr. Janet Kowalski. The medical records note that

A.F. had recently started attending daycare and that she had been experiencing cold symptoms for

more than four weeks. Ex. 11 at 3. These symptoms included cough, congestion, and wheezing.

Id. A.F. had no fever, had a normal appetite, and was sleeping well. Id. A.F. had been to the doctor

1.5 weeks into her illness and her caregivers were advised that she had a viral illness that would

“run its course.” Id. A.F.’s mother and grandmother brought her back to the doctor because she

was not getting better. Id. During the physical exam, Dr. Kowalski observed “left TM [tympanic

membrane] with pus superiorly” and nasal congestion. Id. at 4. Dr. Kowalski diagnosed A.F. with

acute otitis media of the left ear without perforation of the ear drum and nasopharyngitis (common

cold). Id. at 5. Dr. Kowalski prescribed a 10-day course of amoxicillin. Id.

Petitioner brought A.F. to the doctor on December 12, 2015. Ex. 2 at 125. The medical

record documents that she was a little fussier than normal and had re-developed some congestion

over the past one and one half days, although there was no change in her eating. Id. at 125. The

records note that A.F. “has a [history of] ear infection for which she was treated with amoxicillin”

that she finished about eight days ago. Id. at 125. “Her main symptom[] at that time was congestion

which cleared immediately with the amoxycillin.” Id. A.F.’s temperature was measured at 98.5˚F.

Id. at 126. The physical exam conducted on December 12 documented that A.F. was “well-

appearing, smiling and interactive.” Id. She fussed a little but was easily consolable. Id. A.F. was

diagnosed with a “probable ear viral illness.” Id. at 126.

A.F. returned to the pediatrician (Dr. Miller) on Thursday, December 17, 2015. Her mother

reported that she was notified by daycare that A.F. had a fever of 101.8˚F. Ex. 2 at 138. The

medical record documents that in the beginning of December, A.F. had congestion that cleared

after she was treated with amoxycillin. Id. A.F.’s mother reported that A.F.’s current symptoms

began six days prior, and for the past few days, her “fussiness had actually improved.” Id. At the

visit on the 17th, A.F. was congested, but was otherwise well appearing. Id. She was eating well.

Id. A.F. was diagnosed with a fever (measured at 99.9˚F) with a likely viral etiology. Id. at 138-

39. The doctor discussed otitis media with A.F.’s mother, and directed that A.F. begin antibiotics

only if she did not improve in a couple of days. Id. at 139. Dr. Miller prescribed cefdinir. Id.

On Sunday, December 20, 2015, A.F. returned to the pediatrician. Ex. 2 at 153. The record

documents that on Thursday (December 17), she started with a fever and an ear infection. Id. For

the past three days, A.F. was “very fussy (screaming, crying), not eating, not sleeping, not

coughing, little bit of rattling breathing, spitting up a little more than normal, red face, fever, not

diarrhea.” Id. A.F. began taking the cefdinir that Dr. Miller prescribed on Saturday, December 19,

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and had taken three doses at the time of her appointment on the 20th. Id. A.F.’s physical exam

noted that she was alert and interactive. Id. The exam documented several shallow ulcers in the

posterior pharynx and papules on her chest and back as well as 50% clear fluid bilaterally in the

ears. Id. Her temperature was measured at 98.6˚F. Id. She was diagnosed with herpangina6 and a

bilateral middle ear effusion. Id. The doctor noted it was okay to stop cefdinir. Id.

A.F. visited the emergency room in the morning on December 21, 2015 with a chief

complaint of a fever. Ex. 1 at 13. Her temperature was measured at 100.5˚F. Id. at 14. The ED

provider notes document the following:

This 5 m.o. female patient presents to the ER for multiple symptoms. Parents first

noted child not acting right 10 days ago, was lethargic for 2-3 days. Diminished

appetite. No vomiting. No tactile fever. Patient was checked in clinic and diagnosed

a viral syndrome. Child seems better from Monday through Wednesday of last

week. Last Thursday, the child developed a fever of 101.8. Again, appetite

diminished, increased fussiness and difficult to console. Seen on Thursday and

diagnosed with pink ears, prescribed antibiotic to start if symptoms did not improve

over 24 hours. Advised have not yet been started. Yesterday child was fussy,

diminished appetite, seen at after hours clinic and diagnosed with hand-foot-and-

mouth disease. Advised by the doctor there to use ibuprofen, one dose given this

morning at 5:45 AM. New since awakening this morning, family feels the child has

disconjugate gaze with the left eye deviating preferentially to the right. Child took

a first bottle during this interview in the emergency department, drank 2 ounces. 2

episodes of vomiting at home earlier this morning. Mother noted one loose stool

that was dark red in color yesterday.

Ex. 1 at 14-15. A.F.’s lab results were positive for respiratory syncytial virus (“RSV”). Id. at 18.

She was admitted to the hospital; Dr. Bendegom’s impression was RSV, likely sepsis, and VI

cranial nerve palsy on the left side. Id. at 19.

Upon admission, the HPI portion of the medical record documents the following:

10-day history of intermittent fevers and diarrhea and consulted for abnormal eye

movements. Mother reports over the last approximately 10 days she has been ill,

what she describes as having intermittent diarrhea, intermittent fevers, poor p.o.7

intake, being more fussy, and more sleepy than normal. Her mother reports,

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Herpangina: “an acute infectious disease caused by either group A or group B coxsackievirus or by

echoviruses, chiefly affecting young children in the summer; characteristics include vesiculoulcerative

lesions on the mucous membranes of the throat, dysphagia, vomiting, and fever. Called also aphthous

pharyngitis, vesicular pharyngitis, and herpes angina. DORLAND’S, www.dorlandsonline.com/dorland/

definition?id=22347 (last visited Nov. 7, 2023). Herpangina is a viral infection that spreads quickly among

children, especially in a day care setting. It is closely related to hand, foot, and mouth disease.

www.my.clevelandclinic.org/health/diseases/22508-herpangina (last visited May 10, 2024).

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Per os: by mouth. DORLAND’S, www.dorlandsonline.com/dorland/definition?id=38144&searchterm

=per+os (last visited Nov. 8, 2023).

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however, yesterday she noticed that her left eye could not look outward so she was

brought to an outside emergency room.

Ex. 4 at 139. A.F. had an MRI while she was hospitalized, which led to a diagnosis of ADEM. Id.

at 137. Upon review of the MRI, one of her treating physicians commented that “most cases of

ADEM have an antecedent infection, which AF seems to have had several possible recent

infections. She is also RSV +.” Id. During a consult on December 22, 2015, a treating neurologist

opined as follows: “At this time given her prodromal illness, most likely diagnosis is a

postinfectious process most consistent with acute disseminated encephalomyelitis or ADEM.” Id.

at 140. She was started on methyl prednisone. Id.

On December 24, 2015, attending physician Dr. Shannon Dean noted that A.F. was

exhibiting signs of hypothermia and bradycardia, as well as “decreased perfusion of the lower

extremities likely due to autonomic instability secondary to ADEM.” Ex. 4 at 119. An NJ tube was

placed to help ensure adequate nutrition. Id. A.F. remained very irritable. Id. Dr. Dean opined as

follows:

ADEM is a clinical and radiologic diagnosis. With her preceding apparent viral

illness with fever and non-specific symptoms, this does seem to be the best fit

diagnosis. Parents did ask about immunizations as a culprit. She received her 4

month shots on 11/3/15. I indicated that I did not think the time course fit with that

as an etiology and favored a viral illness as etiology.

Id.

On December 26, 2015, Dr. Dean noted that A.F. had shown improvement in tracking

objects, and was neurologically stable. Ex. 4 at 100.

On December 28, 2015, an MRI documented “Rapidly progressive largely symmetrical

destructive process centered at grey-white matter junction, most likely infectious or parainfectious

demyelination with reactive edema in the central white matter.” Id. at 25. A.F. continued to

improve and was discharged from the hospital on December 31, 2015. Id. at 25-26.

A.F. had a follow-up neurology visit on January 5, 2016. Ex. 4 at 463. A.F.’s grandmother

reported that A.F. had made dramatic improvement and that her eyes seem almost back to normal.

Id. The neurologist noted a “dramatic improvement in mood and behavior since admission.” Id. at

464.

A.F. visited a pediatric neurologist on January 26, 2016, and was noted to be back to her

baseline with no deficits. Id. at 575.

No other medical records necessary to my resolution of this matter have been submitted.

IV. Expert Opinions and Qualifications

A. Petitioner’s Expert: Dr. David Younger, M.D.

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Dr. Younger received his bachelor’s degree from the University of Michigan in 1976 and

his medical degree from Columbia University in 1981. Ex. 14 (“Younger CV”) at 1. He completed

residencies in internal medicine in 1981 and neurology in 1984. Id. Dr. Younger is a professor of

neuroscience at City University Medical School. Id. He is board-certified in internal medicine,

clinical neurophysiology, neurology, and electrodiagnostic medicine. Id.

Dr. Younger submitted one expert report. Ex. 13 (hereinafter “Younger Rep.”). He

described ADEM as “a monophasic, immune-mediated central nervous system (CNS)

demyelinating disorder that predominates among children following specific viral infections

including measles, rubella, and mumps, especially in the spring and winter months, and after

vaccine immunization.” Younger Rep. at 3. Dr. Younger noted that after vaccination, A.F. suffered

from an interim RSV infection and an ear infection before developing ADEM. Id.

Dr. Younger characterized A.F.’s condition as a progressive illness. Younger Rep. at 4. He

noted that her illness began with “GI symptoms, congestion, spitting up, and green stools, milk

protein intolerance, and reflux” and that it progressed to “a fever of 101.8 degrees followed by

fussy, crying, coughing, feverish, rattling breathing, insomnia, and loss of appetite with shallow

ulcers in the posterior pharynx and papules on her chest and back.” Id. He opined this then resulted

in “left eye deviation, VI cranial nerve palsy on the left side and the necessity of steroids for

emergent spastic paraparesis and altered limb tone due to ADEM noted on brain MRI.” Id. Dr.

Younger did not explain how all these signs and symptoms constituted a progressive disease

course.

Dr. Younger opined that A.F.’s clinical course was more likely than not, caused by the

Hepatitis B vaccine. Younger Rep. at 4. He stated that “The disease is due to a heightened immune

response to exogenous stimulation associated with vaccination including activation of polyclonal

B-cells, and explains the proximate effect of the claimant’s vaccination and its ensuing sequence

of events that included acute, subacute and chronic neurological findings…” Id. Specifically, Dr.

Younger opined that the Hep B vaccine provoked the activation of B cells, which resulted in an

“aberrant response” and an “upregulation of antibody production directed against host self-

antigens.” Id. Dr. Younger further opined that “post-vaccination demyelinating encephalomyelitis

is more serious and immune-based when it is amplified by concomitant infection as in this child.”

Id.

Dr. Younger discussed the timing of A.F.’s condition, and stated the following: “Within

the first 48 hours of vaccination with subunit portion of the microbe as antigen for immune

surveillance to confer immunity, the claimant developed systemic symptoms as the initial

manifestation of vaccine injury as expected from the physiology of vaccination.” Younger Rep. at

5. It is difficult to understand to which systemic symptoms Dr. Younger refers. In response to the

question, “please explain when the injury onset occurred”, Dr. Younger replied:

Vaccination promotes an immediate activation of polyclonal B-cells pursuant to

presentation of the vaccination antigen in the trimolecular complex which also

includes naïve T-cells and CD68 macrophage antigen presenting cell in the

presence of main histocompatibility (MHC) type 2 molecules. It is the exposure of

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a vulnerable host to an antigenic challenge multiplied by protective host immunity

and conditioned by genetic factors that causes protective host immunity to become

the source of host autoimmunity and the source of progressive disabling

neurological conditions such as ADEM in this patient.

Id. at 5-6. Dr. Younger concluded his report by stating that all three of the Althen prongs had been

met. Id. at 6.

B. Petitioner’s Expert: Dr. Alberto Martinez-Arizala, M.D.

Dr. Martinez-Arizala graduated with a B.S. from Florida State University and a medical

degree from the University of Miami School of Medicine. Ex. 23 (“Martinez-Arizala CV”) at 1.

He completed an internship at the Walter Reed Army Medical Center and a residency in neurology

in the Letterman Army Medical Center in San Francisco. Id. He is a board certified neurologist

and a Professor of Clinical Neurology at the University of Miami Miller School of Medicine. Id.

at 1, 2.

Dr. Martinez-Arizala submitted two expert reports in this case. Ex. 22 (“First Martinez-

Arizala Rep.”); Ex. 41 (“Second Martinez-Arizala Rep.”). Dr. Martinez-Arizala opined that A.F.’s

ADEM was likely caused by the vaccinations she received on November 3, 2015, specifically the

Hep B vaccine. First Martinez-Arizala Rep. at 1, 6. He provided four reasons for this opinion.

First, he stated that the time between vaccination and onset of symptoms was within the interval

one would expect for vaccine causation. Id. at 6. Dr. Martinez-Arizala noted that vaccination was

on November 3, 2015, and that onset of A.F.’s ADEM was on December 12, 2015 where she was

noted to have a low-grade fever and was observed to be a little fussier than normal. Id. He stated,

“Although this could also have been associated with her viral illnesses, the timing of the onset of

her symptoms implicates the vaccine. By her 12/20/2015 visit to Dr. Kreckman, infant Fisher was

worse, and by 12/21/2015 she had clearly developed a neurological disorder (dysconjugate gaze).”

Id. Second, Dr. Martinez-Arizala noted that A.F. had comprehensive imaging studies and these

studies did not reveal another etiology for her condition. Id. Third, he stated that “the time for

progression and resolution was well within what has been reported for ADEM.” Id. And finally,

Dr. Martinez-Arizala stated that A.F.’s treating physicians all agreed with the diagnosis of ADEM.

Id.

Dr. Martinez-Arizala described ADEM as “a demyelinating disease of the central nervous

system that usually presents as a monophasic disorder associated with multifocal neurologic

symptoms and encephalopathy.” First Martinez-Arizala Rep. at 6. He opined that the most

common causes are an infection or a vaccine and that neurologic symptoms follow “days to weeks

after an infection or vaccination.” Id. at 6-7. Dr. Martinez-Arizala noted that encephalopathy is a

required finding in ADEM cases and that encephalopathy typically develops rapidly, in

conjunction with other neurologic deficits. Id. at 7.

Dr. Martinez-Arizala opined that molecular mimicry is the likely causal mechanism

whereby ADEM would develop after vaccination. He described that molecular mimicry occurs

“where components of the vaccine possess sequence similarities between it and specific human

proteins that results in the cross-activation of autoreactive T or B cells.” First Martinez-Arizala

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Rep. at 7. Dr. Martinez-Arizala referenced the 1976 swine flu vaccine leading to an increased risk

of Guillain Barré syndrome (GBS) as an example of vaccination resulting in disease via molecular

mimicry. Id. Dr. Martinez-Arizala stated it is theorized that post-vaccination ADEM results from

molecular mimicry between infectious agents and self-antigens. Id. In support of this assertion,

Dr. Martinez-Arizala cited to Azumagawa. Azumagawa et al., Post-vaccination MDEM associated

with MOG antibody in a subclinical Chlamydia infected boy, 38 BRAIN AND DEVELOPMENT 690-

93 (2016) (filed as Ex. 18) (hereinafter “Azumagawa”). Azumagawa described a case report of a

young boy who developed multiphasic disseminated encephalomyelitis after vaccinations for

measles and rubella, and the booster immunization for Japanese encephalitis. He tested positive

for both anti-myelin oligodendrocyte glycoprotein (MOG) antibodies and Chlamydophila

pneumoniae antibodies. First Martinez-Arizala Rep. at 7; Azumagawa at 690.

In discussing the logical sequence of cause and effect, Dr. Martinez-Arizala stated:

The Hepatitis B vaccine contains components that triggered the ADEM. The onset

of her neurological symptoms was well within the expected time boundaries of the

vaccine administration. There was no evidence from the medical records that infant

Fisher was suffering from any neurological disorder prior to the vaccination in

question. In fact, the contemporaneous medical records are consistent in placing the

start of her neurological symptoms after the vaccination.

First Martinez-Arizala Rep. at 9. With regard to timing, Dr. Martinez-Arizala opined that it was

consistent with the medical literature. Id. He concluded his report by stating that the weight of the

evidence supports his position that the Hep B vaccine caused A.F. to develop ADEM. Id.

Unlike in his first expert report, in his second report, Dr. Martinez-Arizala opined that the

onset of A.F.’s ADEM was December 10, 2015. Second Martinez-Arizala Rep. at 1. He further

opined that “Assuming that infant Fisher’s ADEM was post-viral, then it is quite plausible the

vaccine worsened her disease.” Id. In support of this position, Dr. Martinez-Arizala analogized

this case to MS, where it is recommended that vaccines not be administered close in time to a flare

of MS to avoid worsening disease symptoms. Id.

C. Respondent’s Expert: Dr. Gregory Holmes, M.D.

Dr. Holmes received his medical degree from Washington and Lee University, and he holds

an honorary medical degree from Harvard Medical School. Ex. B (hereinafter “Holmes CV”) at 1.

He completed his residency in pediatrics at the Yale University School of Medicine and another

residency in neurology at the University of Virginia School of Medicine. Id. He is board certified

in pediatrics, neurology with special competence in child neurology, and clinical

neurophysiology. Id. Dr. Holmes has also held various academic appointments, including his

current positions as professor of neurology and pediatrics at Dartmouth Medical School and Chair

of Neurological Sciences at the University of Vermont. Id. at 2. Dr. Holmes is on the editorial

board for a number of medical and scientific journals including the Journal of Epilepsy, Brain &

Development, Pediatric Neurology, Annals of Neurology, and Neurotherapeutics. Id. at 5. Dr.

Holmes has published over 300 peer-reviewed articles, 76 books and book chapters, and over 400

abstracts. Id. at 40-65, 79-84, 85-115.

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Dr. Holmes authored three expert reports in this case. Ex. A (hereinafter “First Holmes

Rep.”); Ex. E (hereinafter “Second Holmes Rep.”); and Ex. F (hereinafter “Third Holmes Rep.”).

Dr. Holmes provided an extremely thorough recitation of A.F.’s medical history. First

Holmes Rep. at 1-11. Dr. Holmes next provided a summary of ADEM. He stated that ADEM,

synonymous with postinfectious encephalomyelitis, is a “demyelinating disease of the central

nervous system that typically presents as a monophasic disorder associated with multifocal

neurologic symptoms and encephalopathy.” Id. at 12. Dr. Holmes elaborated that ADEM is mostly

preceded by febrile or viral infections affecting young adults and children and an antecedent fever

or infection is found in approximately 75% of children with ADEM. Id. Dr. Holmes added that

neurological symptoms usually appear 4-13 days after the antecedent infection. Id. The diagnostic

criteria for ADEM in children was developed in 2007 and updated in 2012, with major criteria

being: 1) a polyfocal clinical attack of CNS demyelinating disease, 2) encephalopathy that cannot

be explained by fever, systemic illness, or postictal symptoms, 3) the absence of clinical and MRI

findings three or more months after onset, 4) an abnormal brain MRI during the acute phase with

diffuse, poorly demarcated, large lesions in the white matter, and deep gray matter lesions. Id. at

11-12. Dr. Holmes stated that the diagnostic criteria require an “absence of new clinical and MRI

findings three months or more after onset” because ADEM is typically monophasic and

improvement occurs quickly with treatment. Second Holmes Rep. at 2. Recurrent or multiphasic

ADEM is rare and constitutes a separate diagnosis; this issue is not relevant because A.F. suffered

from a single attack of ADEM. Id.

Dr. Holmes opined that A.F.’s ADEM began on December 21, 2015, almost seven weeks

after her November 3, 2015 vaccination. First Holmes Rep. at 13-14. Dr. Holmes cited A.F.’s

treater Dr. Dean, who also believed her 4-month vaccinations did not temporally fit as an etiology.

Id. at 14; see also Ex. 4 at 118-20. A.F. received her next round of vaccinations in February 2016

without incident. First Holmes Rep. at 14; see also Ex. 2 at 180-83.

Dr. Holmes provided his opinion regarding Dr. Younger’s theory of causation. Dr. Holmes

stated that there are studies which demonstrate no relationship between vaccinations and ADEM,

including the Hepatitis B vaccine. First Holmes Rep. at 15. Dr. Holmes contended that the medical

literature submitted by Dr. Younger did not support his causation theory. Id. at 16. Dr. Holmes

opined that Dr. Younger has not submitted any evidence that the Hepatitis B vaccines has a

molecular mimic with the brain. Id.

In Dr. Holmes’ final report, he responded to Dr. Martinez-Arizala’s report. Dr. Holmes

reiterated that Dr. Martinez-Arizala, similar to Dr. Younger, espouses a theory of molecular

mimicry but also has not provided any homology between the Hepatitis B vaccine and any brain

peptide. Third Holmes Rep. at 1-2. Dr. Holmes also criticized Dr. Martinez-Arizala’s use of the

Rojas paper, as the paper discusses four major criteria to support a molecular mimicry theory,

which Dr. Martinez-Arizala did not address. Id. at 2. Dr. Holmes last discussed Dr. Martinez-

Arizala’s Althen prong three analysis, and noted that none of his medical literature supported an

onset of either 39 or 48 days after an antecedent event, nor does his cited literature support

Hepatitis B virus causing ADEM. Id. at 2-3.

11

D. Respondent’s Expert, Dr. You-Wen He, M.D., Ph.D.

Dr. He has been a Professor of Immunology in the Department of Immunology at Duke

University Medical Center since 1986. Ex. D (hereinafter “He CV”) at 1. Dr. He received his

medical degree from the Fourth Military Medical University and his Ph.D. from the University of

Miami School of Medicine. He CV at 1. His research areas include innate and adaptive viral and

bacterial immunity; he directed research on human immune responses to viral infections

including influenza, HIV, HBV, and HCV. See generally id. at 5-7. Dr. He has published over 100

peer-reviewed articles. Id. at 8-15.

Dr. He authored one expert report in this case. Ex. C (hereinafter “He Rep.”). Dr. He opined

that he did not believe the Hepatitis B vaccine that A.F. received caused her ADEM. Id. at 5. A.F.

suffered from a number of infections such as an ear infection, hand, foot, and mouth disease, and

RSV prior to her development of ADEM, and there is “overwhelming evidence” of a connection

between infections and ADEM. Id. Dr. He disagreed with Dr. Younger’s assertion that A.F.

suffered from repeat challenge from the Hepatitis B vaccine, which increased her risk of CNS

inflammatory disease or post-vaccination demyelination encephalomyelitis. Id. at 6. Dr. He also

disputed Dr. Younger’s reliance on the Huynh paper, arguing the 2012 IOM publication was a

more recent and comprehensive analysis on vaccine safety. Id.

Dr. He stated that A.F.’s vaccinations on July 12, 2015, September 8, 2015, and November

3, 2015 could not temporally connect to A.F.’s ADEM. He Rep. at 7. Dr. He cited to A.F.’s

multiple infections in November 2015 as more likely to have caused her neurological symptoms.

Id. A.F was treated for an ear infection from November 24-December 4, 2015; the time frame of

A.F.’s ear infection occurred between 2-21 days before the onset of her neurological symptoms,

which better correlates than the Hepatitis B vaccines. Id. Dr. He opined that the immune response

from A.F.’s infection was more robust than the immune reaction from her vaccinations. Id. at 8.

V. Applicable Law

A. Petitioner’s Burden in Vaccine Program Cases

Under the Vaccine Act, a petitioner may prevail in one of two ways. First, a petitioner may

demonstrate that a vaccinee suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury

Table that occurred within the time period provided in the Table. § 11(c)(1)(C)(i). “In such a case,

causation is presumed.” Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed.

Cir. 2006); see § 13(a)(1)(B). Second, where the alleged injury is not listed in the Vaccine Injury

Table, a petitioner may demonstrate that she suffered an “off-Table” injury. § 11(c)(1)(C)(ii).

For both Table and non-Table claims, Vaccine Program petitioners bear a “preponderance

of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that

leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence

before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s

existence.” Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1324 (Fed. Cir. 2010); see

also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation

12

is insufficient under a preponderance standard). Proof of medical certainty is not required. Bunting

v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a petitioner

must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a

substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v.

Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999)); Pafford v. Sec’y of Health

& Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine

Program award based solely on his assertions; rather, the petition must be supported by either

medical records of by the opinion of a competent physician. Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a

non-Table claim, a petitioner must satisfy all three of the elements established by the Federal

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

Althen requires that petitioner establish by preponderant evidence that the vaccinations he received

caused 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 a proximate temporal relationship between vaccination and

injury.” Id. at 1278.

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioner

must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the

type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, a

petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”

Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must

only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioner may satisfy the first Althen prong without resort to medical literature,

epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical

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

Capizzano, 440 F.3d at 1325-26). Special Masters, despite their expertise, are not empowered by

statute to conclusively resolve what are complex scientific and medical questions, and thus

scientific evidence offered to establish Althen prong one is viewed “not through the lens of the

laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence

standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden

placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of

Health & Hum. Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility … in many cases may be

enough to satisfy Althen prong one” (emphasis in original)), vacated on other grounds, 844 F.3d

1363 (Fed. Cir. 2017). But this does not negate or reduce a petitioner’s ultimate burden to establish

her overall entitlement to damages by preponderant evIdence. W.C. v. Sec’y of Health & Hum.

Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).

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

supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,

569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion

testimony are favored in vaccine cases, as treating physicians are likely to be in the best position

to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the

reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed

13

as particularly trustworthy evidence, because they are created contemporaneously with the

treatment of the patient. Cucuras v. Sec’y of Health & Hum. 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 to adopt the conclusions of such an individual, even if they must be

considered and carefully evaluated. Section 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 v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“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”). As with expert testimony offered to establish a

theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the

reasonableness of their suppositions or bases. The views of treating physicians should also be

weighed against other, contrary evidence also present in the record -- including conflicting

opinions among such individuals. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742,

749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’

conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health &

Hum. Servs., No. 06-522V 2011 WL 1935813 at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.

for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed.

Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between

the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the

phrase “medically acceptable temporal relationship.” Id. A petitioner must offer “preponderant

proof that the onset of symptoms occurred within a timeframe which, given the medical

understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan

v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what

is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine

can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &

Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand on other grounds, 105

Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013). Koehn v. Sec’y of Health

& Hum. Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for

review den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law Governing Analysis of Fact Evidence

The process for making factual determinations in Vaccine Program cases begins with

analyzing the medical records, which are required to be filed with the petition. Section 11(c)(2).

The special master is required to consider “all [] relevant medical and scientific evidence contained

in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s

report which is contained in the record regarding the nature, causation, and aggravation of the

petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic

or evaluative test which are contained in the record and the summaries and conclusions.” Section

13(b)(1)(A). The special master is then required to weigh the evidence presented, including

contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3

F.3d 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to

14

afford greater weight to contemporaneous medical records than to other evidence, such as oral

testimony surrounding the events in question that was given at a later date, provided that such

determination is evidenced by a rational determination).

Medical records created contemporaneously with the events they describe are generally

trustworthy because they “contain information supplied to or by health professionals to facilitate

diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby v.

Sec’y of Health & Hum. Servs., 997 F.3d 1378 (Fed. Cir. 2021) citing Cucuras, 993 F.2d at 1528.

This presumption is based on the linked proposition that (i) sick people visit medical professionals;

(ii) sick people honestly report their health problems to those professionals; and (iii) medical

professionals record what they are told or observe when examining their patients in as accurate a

manner as possible, so that they are aware of enough relevant facts to make appropriate treatment

decisions. Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825 at *2 (Fed.

Cl. Spec. Mstr. Apr. 10, 2013) mot. for rev. denied, 142 Fed. Cl. 247, 251-52 (2019), vacated on

other grounds and remanded, 809 Fed. Appx. 843 (Fed. Cir. Apr. 7, 2020).

Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL

6117475 at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records

are generally found to be deserving of greater evidentiary weight than oral testimony–- especially

where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also

Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d

1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States

v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony

which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)).

However, there are situations in which compelling oral testimony may be more persuasive

than written records, such as where records are deemed to be incomplete or inaccurate. Campbell

v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common

sense and experience, this rule should not be treated as an absolute and must yield where the factual

predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475 at *19 (“[w]ritten

records which are, themselves, inconsistent, should be accorded less deference than those which

are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination

regarding a witness’s credibility is needed when determining the weight that such testimony should

be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,

1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to

contemporaneous medical records, such testimony must be “consistent, clear, cogent and

compelling.” Sanchez, 2013 WL 1880825 at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,

No. 90-2808V, 1998 WL 408611 at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the

accuracy and completeness of medical records, the Court of Federal Claims has listed four possible

explanations for inconsistencies between contemporaneously created medical records and later

testimony: (1) a person’s failure to recount to the medical professional everything that happened

during the relevant time period; (2) the medical professional’s failure to document everything

reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;

15

or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v. Sec’y of Health

& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making

a determination regarding whether to afford greater weight to contemporaneous medical records

or other evidence, such as testimony at hearing, there must be evidence that this decision was the

result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory connecting the vaccine to the injury often

requires a petitioner to present expert testimony in support of his or her claim. Lampe v. Sec’y of

Health & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony

is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert

v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum.

Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195

F.3d 1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony

are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or

technique has been subjected to peer review and publication; (3) whether there is a known or

potential rate of error and whether there are standards for controlling the error; and (4) whether the

theory or technique enjoys general acceptance within a relevant scientific community.” Terran,

195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95).

The Daubert factors play a slightly different role in Vaccine Program cases than they do

when applied in other federal judicial fora. Daubert factors are employed by judges to exclude

evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these

factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health

& Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have

been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of

expert testimony already admitted”). The flexible use of the Daubert factors to evaluate

persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88

Fed. Cl. at 743. In this matter, (as in numerous other Vaccine Program cases), Daubert has not

been employed at the threshold, to determine what evidence should be admitted, but instead to

determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s

case. Where both sides offer expert testimony, a special master’s decision may be “based on the

credibility of the experts and the relative persuasiveness of their competing theories.”

Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing

Lampe, 219 F.3d at 1362). However, 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, 88 Fed. Cl. at 743

(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to

require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592

F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a

particular expert’s credibility, is part of the overall reliability analysis to which special masters

must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the

reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y

16

of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously

explained that special masters are expected to consider the credibility of expert witnesses in

evaluating petitions for compensation under the Vaccine Act”).

D. Consideration of Medical Literature

Finally, although this decision discusses some but not all of the medical literature in detail,

I have reviewed and considered all of the medical records and literature submitted in this matter.

See Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We

generally presume that a special master considered the relevant record evidence even though [s]he

does not explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health &

Hum. Servs., 115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every

piece of evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed.

Cir. 2015).

VI. Analysis

Because Petitioner does not allege an injury listed on the Vaccine Injury Table, his claim

is classified as “off-Table.” As noted above, to prevail on an “off-Table” claim, Petitioner must

prove by preponderant evidence that A.F. suffered an injury and that this injury was caused by the

vaccination at issue. See Capizzano, 440 F.3d at 1320.

A. Althen Prong One

Although Dr. Younger and Dr. Martinez-Arizala have articulated a theory describing how

the vaccines A.F. received can cause ADEM, I need not reach that question. My factual findings,

discussed in the next section, that A.F.’s viral infection was the more likely than not cause of her

condition, make analysis of Petitioner’s causal theory unnecessary. See, e.g., Hibbard v. Sec’y of

Health & Hum. Servs., 698 F.3d 1355, 1365 (Fed. Cir. 2012); Holmes v. Sec’y of Health & Hum.

Servs., 115 Fed. Cl. 469, 488 (2014); Vaughan v. Sec’y of Health & Hum. Servs., 107 Fed. Cl. 212,

222 (2012). Accordingly, in my analysis of Althen prongs two and three, I have assumed, but have

not decided that Petitioner has established a medical theory causally linking the flu vaccine to

ADEM.8

B. Althen Prongs Two and Three

Althen prong two requires Petitioner to establish a logical sequence of cause and effect

demonstrating that the vaccination did cause A.F.’s condition. Althen, 418 F.3d at 1278; Andreu,

569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion

testimony are favored in vaccine cases, as treating physicians are likely to be in the best position

to determine whether a ‘logical sequence of cause-and-effect show[s] that the vaccination was the

reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed

8

As discussed later in this decision, I do not find persuasive Dr. Martinez-Arizala’s brief discussion

involving the purported interplay between vaccination and a viral infection which occurred approximately

one month later.

17

as particularly trustworthy evidence, since they are created contemporaneously with the treatment

of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

The timing prong contains two parts. First, a petitioner must establish the “timeframe for

which it is medically acceptable to infer causation” and second, he must demonstrate that the onset

of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed. Cl. 532,

542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d

without op., 503 F. App’x 952 (Fed. Cir. 2013).

1. A.F. had at least one and likely multiple infections before she developed ADEM

Petitioner contends that A.F.’s ADEM began on December 10, 2015, and further, that her

medical records documented “little to no evidence of a viral infection” before that time. Pet’r’s

Reply at 1. As discussed below, I do not find Petitioner’s position to be persuasive.

It is clear that A.F. had one or more infections in the month prior to her onset of ADEM.

On November 24, 2015, A.F. went to the doctor because she had been sick for four weeks and was

still experiencing congestion. Ex. 11 at 3. Dr. Kowalski observed pus in A.F.’s left tympanic

membrane and diagnosed A.F. with acute otitis media of the left ear without perforation of the ear

drum and nasopharyngitis. Id. at 5. Dr. Kowalski prescribed a 10 day course of amoxicillin. Id.

On December 12, 2015, A.F. was presented to the pediatrician because she had completed

her course of amoxicillin about eight days prior, but had redeveloped some congestion over the

past one and one half days. Ex. 2 at 125. The doctor diagnosed A.F. with a “probable ear viral

illness.” Id. at 126.

Dr. Martinez-Arizala contended that A.F. did not have a viral infection at the time of the

December 12 visit. Second Martinez-Arizala Rep. at 1. He stated as follows: “Dr. Ram also

documented that her main symptom at the time of her []ear infection was congestion, which cleared

immediately after completing the amoxicillin. This indicates that [A.F.] had recovered from the

congestion/illness that she had prior to the onset of her excessive sleepiness/fussiness on or about

December 10, 2015.” Second Martinez-Arizala Rep. at 1. Dr. Martinez-Arizala’s opinion is

difficult to square with the medical record. Indeed, one and one half days before this appointment,

A.F. “redeveloped some congestion.” Ex. 2 at 125. This point suggests that A.F. had not “recovered

from her congestion”, as Dr. Martinez-Arizala argued, but that she was sick; A.F.’s congestion

supports her treating physician’s diagnosis of probable viral ear illness.

A.F. returned to the pediatrician on December 17, 2015. Her mother reported that she was

notified by daycare that A.F. had a fever of 101.8˚F. Ex. 2 at 138. At the visit on the 17th, A.F. was

congested. Id. Her left and right tympanic membranes were observed to be erythematous and dull.

Id. A.F. was diagnosed with a fever, measured at 99.9˚F, with a likely viral etiology. Id. at 138-

39. Dr. Miller discussed otitis media with A.F.’s mother and recommended that A.F. begin

antibiotics if she did not improve in one week. Id. at 139.

On Sunday, December 20, 2015, A.F. returned to the pediatrician. Ex. 2 at 153. The record

documents that for the past three days, A.F. had been very fussy. Id. A.F.’s physical exam

18

documented several shallow ulcers in the posterior pharynx and papules on her chest and back as

well as 50% clear fluid bilaterally in the ears. Id. Her temperature was measured at 98.6˚F. Id. She

was diagnosed with herpangina and a bilateral middle ear effusion. Id.

These medical records clearly document the existence of one and likely more than one

infection. The existence of an infection is significant because the medical literature states that

ADEM has an infectious etiology in a high percentage of cases. In fact, ADEM is also referred to

as postinfectious encephalomyelitis. See Cole at 26 (observing that 55% to 86% of pediatric

ADEM cases are preceded by symptoms of a viral illness); Lotze & Chadwick, Acute disseminated

encephalomyelitis (ADEM) in children: Pathogenesis, clinical features, and diagnosis,

UPTODATE, 1-17, 4 (2020) (filed as Ex. A, Tab 19) (noting that approximately 75% of children

with ADEM have an antecedent fever or infection); Paolilo et al., Acute Disseminated

Encephalomyelitis Current Perspectives, 7 CHILDREN 210, 1-15, 4 (2020) (filed as Ex. C, Tab 6)

(stating that a preceding infection is observed in 70%-80% of ADEM cases).

I acknowledge that Petitioner is not required to eliminate other potential causes of ADEM

in order to be entitled to compensation in the Vaccine Program. See Walther v. Sec’y of Health &

Hum. Servs., 485 F.3d 1146, 1149-52 (Fed. Cir. 2007) (concluding a petitioner does not bear the

burden of eliminating alternative independent potential causes). However, I find it appropriate to

consider other possible sources of injury in making a determination pursuant to Althen prong

two. See Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373, 1379-80 (Fed. Cir. 2012); see

also Winkler v. Sec’y of Health & Hum. Servs., 88 F.4th 958, 963 (Fed. Cir. 2023), pet. for panel

rehearing and rehearing en banc denied, No. 22-1960 (Mar. 28, 2024). A.F.’s illness or illnesses

are a likely source of her injury.9

2. Treating physicians

In weighing evidence, special masters are expected to consider the views of treating

doctors. Capizzano, 440 F.3d at 1326. The views of treating doctors about the appropriate

diagnosis are often persuasive because the doctors have direct experience with the patient whom

9

In his second expert report, Dr. Martinez-Arizala dedicated one paragraph to a new theory. He stated,

“Assuming that infant Fisher’s ADEM was post-viral, then it is quite plausible the vaccine worsened her

disease.” Second Martinez-Arizala Rep. at 1. He cited two articles involving multiple sclerosis as support

for his theory, noting that “[i]n MS it is recommended that vaccines not be administered close to an

exacerbation to avoid worsening the relapse.” Id. Dr. Martinez-Arizala’s new theory is unpersuasive. First,

the two articles he filed were about MS, and not ADEM. Second, these articles note that neurologists

typically do not give prophylactic vaccines (like Hep B) during a “significant relapse” of MS (defined as

“one that causes motor symptoms or severe sensory symptoms that have affected the patient’s usual ability

to carry out daily activities”), because “the vaccination might cause side effects, such as fever, that could

worsen the relapse.” Ex. 44 at 19. A.F. did not have ADEM at the time of vaccination, and thus was not

experiencing a relapse. Finally, Dr. Martinez-Arizala did not explain how a vaccination administered on

November 3 could linger in the body and interact with a subsequent infection or infections and result in the

onset of ADEM 48 days later. This proposed mechanism was left completely unexplained. As such, I do

not find that this causal theory is persuasive or that there is support in the record that it happened in A.F.’s

specific case.

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they are diagnosing. See McCulloch v. Sec’y of Health & Hum. Servs., No. 09-293V, 2015 WL

3640610, at *20 (Fed. Cl. Spec. Mstr. May 22, 2015).

Several of A.F.’s treating physicians documented that A.F.’s condition was likely caused

by an infection. Dr. Samuel Dzodzomenyo, A.F.’s treating neurologist opined: “At this time given

her prodromal illness, most likely diagnosis is a post-infectious process most consistent with

ADEM.” Ex. 4 at 140. Pediatrician Dr. Mary Ehlenbach opined as follows: “MRI findings along

with minimal nucleated cells in the CSF and neurologic symptoms are consistent with a diagnosis

of acute demyelinating encephalomyelitis (ADEM). Most cases of ADEM have an antecedent

infection, which [A.F.] seems to have had several possible recent infections. She is also RSV +.”

Ex. 4 at 137. Dr. Shannon Dean, one of A.F.’s pediatricians noted the following in the medical

record: “My assessment is 5 month-old with bilaterally cranial nerve 6 palsies and MRI findings

suggestive of ADEM. … With her preceding apparent viral illness with fever and non-specific

symptoms, this does seem to be the best fit diagnosis. Parents did ask about immunizations as a

culprit. She received her 4 month shots on 11/3/15. I indicated that I did not think the time course

fit with that as an etiology and favored a viral illness as an etiology.” Ex. 4 at 118-20. None of

A.F.’s treating doctors ascribed causation of her ADEM to the vaccines she received.

These opinions are persuasive evidence and help establish that A.F.’s ADEM was more

likely than not, caused by an infection.

3. Onset of A.F.’s ADEM

Initial symptoms of ADEM are described in the literature as highly variable. Cole at 27.

That being said, most children present with a fever, headache, and nausea. Id. By definition, all

children must have an encephalopathy in order to meet the diagnostic criteria. Id. Encephalopathy

in young children can present as irritability, sleepiness, confusion, lethargy, or coma. Id. at 28.

Cranial nerve deficits are also observed in 18%-39% of ADEM cases. Id.

Petitioner presented different positions on the onset of A.F.’s ADEM. Dr. Younger

contended that the “initial manifestation of vaccine injury” occurred within the first 48 hours of

vaccination. Younger Rep. at 5. This position finds no support in the medical records and will not

be discussed further. Dr. Martinez-Arizala initially opined that “the onset of the illness most likely

dates to her 12/12/2015 visit with Dr. Ram, where she was noted to have a low-grade fever and

being a little fussier than usual. Although this could also have been associated with her viral

illnesses, the timing of the onset of her symptoms implicates the vaccine.” First Martinez-Arizala

Rep. at 6. Dr. Martinez-Arizala did not clarify why he believed the vaccine was causal if the timing

of onset implicated the viral illness. However, in his second report, Dr. Martinez-Arizala argued

that A.F.’s lethargy and fussiness on December 10, 2015 marked the beginning of her ADEM.

Second Martinez-Arizala Rep. at 1. Petitioner advocates this third position in his briefs. See e.g.,

Pet’r’s Reply at 7. While it is true that lethargy and fussiness can be present in ADEM, these are

non-specific symptoms that also exist in many other conditions, including viral infections. Dr.

Holmes opined that A.F. experienced the onset of her condition between December 17 and

December 21, 2015. Second Holmes Rep. at 2; Third Holmes Rep. at 2. Dr. Holmes further opined

that it is “highly unlikely” that A.F. developed ADEM on December 12, 2015. Third Holmes Rep.

at 2.

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In reviewing the medical records, I conclude that Petitioner’s presentation on December

10, December 12, December 17, and December 20 can be explained by the illness or illnesses she

was experiencing. While she was described as fussy on each of these dates, I do not find this

description preponderantly supports the onset of ADEM.

For example, on December 1010 and 12, 2015 A.F. was described as “a little fussier than

normal”, and the medical record notes that her parents brought her to the doctor because she had

been more lethargic than normal for the past 36 hours and had re-developed some congestion

during this 36 hour period of time. However, there was no change in her eating, she was “easily

consolable” and was noted to be “well-appearing, smiling and interactive” on physical exam. Ex.

2 at 125. In the context of the overall medical record, it appears that A.F. was likely still battling

an infection.

On December 17, 2015 A.F. had a fever, was congested, and was fussy. Ex. 2 at 138. Her

left and right tympanic membranes were observed to be erythematous and dull. Id. A.F. was

diagnosed as having a fever with a likely viral etiology. Id. at 138-39. Although A.F. was fussy

during this visit, she also had what appeared to be the continuation of an ear infection.

On Sunday, December 20, 2015, A.F. was “very fussy” and had been for the past three

days. Ex. 2 at 153. A.F.’s physical exam documented several shallow ulcers in the posterior

pharynx and papules on her chest and back as well as 50% clear fluid bilaterally in the ears. Id.

She was diagnosed with herpangina and a bilateral middle ear effusion. Id. A.F.’s extreme

fussiness was likely attributable to her continued ear infection and her new diagnosis of

herpangina.

It is difficult to distinguish between A.F.’s viral illness which likely caused lethargy and

fussiness and the precise onset of her ADEM. However, based on the above, I conclude there is

not preponderant evidence that the fussiness and lethargy A.F. experienced before December 21,

2015, constituted the onset of her condition. I find there is preponderant evidence that A.F.’s fever,

repeated vomiting, and disconjugate gaze, which began the morning of December 21, 2015

represent the onset of her disease course.

4. Onset interval makes it more likely that the infection was causal

The medical literature describes that when patients have prodromal illness, the latency

between infection and onset of ADEM can be measured in days to weeks. For example, Murthy et

al. found that 72% of the children studied had an upper respiratory tract infection between two

days and four weeks prior to onset of ADEM. Murthy at 2. Murthy concluded that on average, 10

days separated the URI from onset of neurologic symptoms. Id. Cole et al. noted that “The latent

period between an inciting viral infection and onset of symptoms is typically about 12 days.” Cole

at 27. Menge et al. observed, “Typically, the latency between a febrile illness and the onset of

neurological symptoms is 7–14 days.” Menge et al., Acute disseminated encephalomyelitis: an

10

Although there is no medical visit for December 10, the visit on the 12th refers to symptoms that began

36 hours prior.

21

acute hit against the brain, 20 CURRENT OPINION IN NEUROLOGY, 247-254, 247 (2007) (filed as

Ex. A, Tab 29). Given the fact that A.F. had symptoms of one or more infections during the 30+

days before the onset of ADEM, I conclude the timing of A.F.’s illness persuasively connects them

with her development of ADEM.

Further, the fact that A.F. developed ADEM 48 days after vaccination, reduces the

likelihood of the vaccine’s causal role. Indeed, Petitioner’s own literature describes onset of

ADEM within days to weeks of vaccination. Huynh et al. discussed the onset of symptoms in

ADEM. They stated: “Depending on the inciting agent, the onset of symptoms may vary slightly:

from 1 to 14 days with non-neural vaccines … and 1 to 3 weeks after rabies vaccination.” Huynh

et al., Post-vaccination encephalomyelitis: Literature review and illustrative case, 15 JOURNAL OF

CLINICAL NEUROSCIENCE, 1315-22, 1319 (2008) (filed as Ex. 19) (hereinafter “Huynh”). Pavone

et al. described that the interval between vaccination and onset of ADEM was seven days. Pavone

et al., Acute Disseminated Encephalomyelitis: A Long-Term Prospective Study and Meta-Analysis,

42 NEUROPEDIATRICS 1-10, 3 (2011) (filed as Ex. 28). The longest interval is described by Dale et

al., who noted that the mean latency between an illness or vaccination and the onset of neurological

signs was 13.0 days, with a range of two to 31 days. Dale at 2410.

These findings regarding the timing of the infection versus the vaccination are in accord

with the opinion of Dr. Dean, one of A.F.’s treating physicians, who noted that she “did not think

the time course fit with [vaccination] as an etiology and favored a viral illness as etiology.” Ex. 4

at 119; see also White v. Sec’y of Health & Hum. Servs., No. 20-1319V, 2023 WL 4204568, at *18

(Fed. Cl. Spec. Mstr. June 2, 2023) (opining that an infection was more likely causal than

vaccination when the infection was closer to the onset of disease than vaccination); mot. for rev.

denied, 168 Fed. Cl. 660 (2023); appeal docketed, No. 2024-1372 (Fed. Cir. Jan. 23, 2024). The

existence of this other source of injury, an infection, weakens the persuasiveness of Petitioner’s

prong two showing in that it reduces the likelihood of the vaccine’s causal role.

In summary, A.F. experienced at least one and likely multiple illnesses in the four weeks

prior to the onset of her condition. The existence of these illnesses, coupled with the opinions of

her treating physicians and the opinion of Dr. Holmes prevent her from establishing that the

vaccines she received “did cause” her condition. Petitioner has not presented preponderant

evidence in support of the second or the third Althen prongs.

VII. Conclusion

Upon careful evaluation of all the evidence submitted in this matter, including the medical

records, the affidavits, as well as the experts’ opinions and medical literature, I conclude that

Petitioner has not shown by preponderant evidence that he is entitled to compensation under the

Vaccine Act. His petition is therefore DISMISSED. The clerk shall enter judgment

accordingly.11

IT IS SO ORDERED.

11

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly

or separately) a notice renouncing their right to seek review.

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s/ Katherine E. Oler

Katherine E. Oler

Special Master

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