VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-00722
Package ID: USCOURTS-cofc-1_17-vv-00722
Petitioner: K.N.
Filed: 2017-05-31
Decided: 2023-08-03
Vaccine: Tdap
Vaccination date: 2014-06-07
Condition: Myelin Oligodendrocyte Glycoprotein (MOG) Antibody Disease (MOGAD)
Outcome: compensated
Award amount USD: 194139

AI-assisted case summary:
On May 31, 2017, L.C. filed a claim on behalf of her minor daughter, K.N., alleging that K.N. suffered a neurological demyelinating disorder as a result of receiving a Tdap vaccine on June 7, 2014. K.N. was ten years old at the time of vaccination. Within two weeks of vaccination, K.N. began experiencing headaches and vision problems, leading to a diagnosis of bilateral optic neuritis (ON) and suspected acute disseminated encephalomyelitis (ADEM). Over the following months, K.N. experienced further neurological symptoms, including left-sided weakness, and was diagnosed with Myelin Oligodendrocyte Glycoprotein (MOG) Antibody Disease (MOGAD). Petitioner presented expert testimony from Dr. Robert Stone, who argued that the Tdap vaccine caused K.N.'s MOGAD through mechanisms such as molecular mimicry or bystander activation. Respondent's expert, Dr. Marc Bouffard, opined that the vaccine did not cause the MOGAD, citing a lack of reliable evidence linking vaccines to MOGAD and arguing that other conditions are not interchangeable with MOGAD. Chief Special Master Brian H. Corcoran issued an Entitlement Ruling on July 2, 2021, finding that Petitioner met her burden of proof and was entitled to compensation. A subsequent Decision Awarding Damages, issued by Chief Special Master Corcoran on August 3, 2023, awarded K.N. $194,139.19. This award comprised $190,000.00 for pain and suffering, $2,190.00 for future unreimbursed expenses, and $1,949.19 for past unreimbursed expenses. Petitioner K.N. later filed a Motion for Review regarding redaction of her name and birth date from public records, which was partially granted by Judge Marian Blank Horn on August 22, 2023, allowing her name to be redacted to initials and her birth date to only the year, but not her mother's name. Petitioner counsel was Ronald Craig Homer, and respondent counsel was Mollie Gorney, later Naseem Kourosh.

Theory of causation field:
Petitioner K.N., a 10-year-old female, received a Tdap vaccine on June 7, 2014. Within two weeks, she developed headaches and vision problems, progressing to bilateral optic neuritis (ON) and later diagnosed with Myelin Oligodendrocyte Glycoprotein (MOG) Antibody Disease (MOGAD), a neuroinflammatory condition. Petitioner's expert, Dr. Robert Stone, argued that the Tdap vaccine caused K.N.'s MOGAD through molecular mimicry or bystander activation, citing literature linking vaccines to similar acute demyelinating injuries like ADEM and ON, and noting that MOGAD is a recently defined entity potentially misdiagnosed as ADEM in the past. Respondent's expert, Dr. Marc Bouffard, contended that there was insufficient evidence to link vaccines to MOGAD and that MOGAD is not interchangeable with other demyelinating conditions. Chief Special Master Brian H. Corcoran found that Petitioner met the Althen prongs, establishing a medically acceptable theory (Tdap can cause MOGAD), a logical sequence of cause and effect (symptoms began within weeks of vaccination and progressed consistent with MOGAD), and a proximate temporal relationship (onset within three weeks of vaccination). The Special Master ruled that Petitioner was entitled to compensation. Damages were awarded on August 3, 2023, totaling $194,139.19 ($190,000.00 for pain and suffering, $2,190.00 for future unreimbursed expenses, and $1,949.19 for past unreimbursed expenses). Petitioner's counsel was Ronald Craig Homer, and respondent's counsel was Mollie Gorney, later Naseem Kourosh. Chief Special Master Corcoran issued the entitlement ruling, and Judge Marian Blank Horn later addressed redaction requests.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_17-vv-00722-1
Date issued/filed: 2021-08-17
Pages: 28
Docket text: PUBLIC ORDER/RULING (Originally filed: 07/06/2021) regarding 88 Ruling on Entitlement Signed by Chief Special Master Brian H. Corcoran. (omg) Service on parties made.
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Case 1:17-vv-00722-MBH Document 95 Filed 08/17/21 Page 1 of 28
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-722V
(To be published)
Chief Special Master Corcoran
L.C., parent of K.N., a minor,
Petitioner,
Dated: July 2, 2021
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, for Petitioner.
Mollie Gorney, U.S. Department of Justice, Washington, DC, for Respondent.
ENTITLEMENT RULING1
On May 31, 2017, L.C. filed a claim filed on behalf of her minor daughter, K.N., for
compensation pursuant to the National Vaccine Injury Compensation Program (the “Vaccine
Program”).2 The Petition alleged that K.N. suffered from a neurological demyelinating disorder as a
result of her receipt of a Tetanus-diphtheria-acellular pertussis (“Tdap”) vaccine on June 7,
2014. Petition (ECF No.1) at 1. An entitlement hearing in the matter was held on March 16,
2021.
Having reviewed the materials filed in this case and considered the parties’
arguments, I hereby find that Petitioner has met her burden of proof, and is therefore
entitled to damages. As discussed in greater detail below, the experts on both sides agreed
that K.N. likely suffered from
1 Because this Decision contains a reasoned explanation for the special master’s action in this case, it will be posted
on the United States Court of Federal Claims’ website in accordance with the E-Government Act of 2002. See 44
U.S.C. § 3501 note (2012) (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, it will be redacted from public access.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”).
All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.
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Myelin Oligodendrocyte G lycoprotein (“MOG”) Antibody Disease (“MOGAD”), a
neuroinflammatory condition and recently-coined diagnostic concept. Although not much is yet
known about MOGAD’s pathogenesis, I find sufficient preponderant evidence was offered in this
case to support Petitioner’s contention that the Tdap vaccine could cause MOGAD, and did so
here.
I. Medical History
K.N. was born in 2004. Ex. 1 at 1. Prior to vaccination, she was a healthy ten year-old
girl. See generally Ex. 2. On June 7, 2014, K.N. received the Tdap vaccine. Ex. 1 at 2; Ex. 2
at 9. Afterwards, K.N. traveled to France for a family vacation, during which time her mother
reported she experienced no medical issues. Ex. 3 at 24-26. Within a couple of weeks of
receiving the vaccine, however, Petitioner asserts that K.N. started complaining of headaches,
and then at the beginning of July began having problems with her vision. Ex. 10 at 2. On July
4, 2014, K.N. woke up crying, telling her mother that she could not see anything. Id. L.C.
therefore rushed K.N. to the emergency room at the California Pacific Medical Center in San
Francisco, California. Id.
Emergency care treaters recorded K.N. as experiencing bilateral vision loss which had
started approximately two to three days earlier. Ex. 3 at 4, 24, 175. It was also noted that K.N. had
a “recent sick contact” with her cousin, who had a fever, but K.N. had not felt ill herself. Id. at 24.
The results of a brain MRI showed “[s]uspected bilateral optic neuritis.” Id. at 168. She received
treatment with high-dose steroids, and on July 5, 2014, was transferred out of the intensive care
unit. Id. at 175. Her pediatric neurologist proposed K.N. had acute disseminated encephalomyelitis
(“ADEM”). Id. at 146.
K.N. remained hospitalized until July 7, 2014, and during that time her vision improved
following treatment with steroids. Ex. 3 at 5. Upon discharge, K.N.’s diagnosis was parainfectious
optic neuritis (“ON”), and her prognosis was deemed excellent. Id. On July 8, 2014, K. N.
underwent a neuro-ophthalmology evaluation with Richard Imes, M.D. Ex. 2 at 50. Petitioner
reported that K.N. “may have [had] a mild fever with a headache a couple of weeks prior to losing
[her] vision.” Id. K.N.’s optic disc swelling had improved, and Dr. Imes recommended tapering
her steroid treatment over the next ten days. Id. He concluded that K.N. most likely had
experienced ON “despite the vague history of an antecedent viral illness… Post-immunization
bilateral optic neuritis is well reported but not after DTaP vaccine.” Id.
On July 23, 2014, K.N. had a follow-up appointment for her ON. Ex. 4 at 1083. Her vision
was 20/150 in her right eye and 20/200 in her left eye. Id. at 1084. The impression was that K.N.
had isolated papillitis bilaterally, and her treater noted it was “[v]ery unlikely to be [multiple
sclerosis] or other systemic pathology and ot [sic] related to recent vaccination as no other cortical
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leukoencephalopathy [was] seen. This condition is thought to be post-viral.” Id. at 1086. On July
29, 2014, K.N. visited ophthalmology for another follow-up and the record noted that the “[p]atient
feels like visual acuity improved…Medications: stopped steroids 2 days ago… Assessment/plan:
optic neuritis: Improving, now feels like visual acuity almost back to baseline.” Ex. 8 at 1.
On August 26, 2014, K.N.’s pediatrician examined her for a recent headache with a fever
(which improved with ibuprofen) and vomiting. Ex. 2 at 8. K.N. also reported decreased energy,
but she denied eye pain or blurriness. Id. Two days later, on August 28, 2014, K.N. presented to
the emergency room at the University of California – San Francisco due to acute onset left-sided
“body shaking, numbness, and weakness.” Ex. 4 at 56. By this time, K.N.’s ON had “nearly
completely resolved.” Id. at 56-57. She was admitted to the pediatric intensive care unit and
underwent a lumbar puncture; the results were “concerning for infection [versus] inflammatory
process.” Id. at 57. An MRI angiography did not show signs of a stroke, mass, or a demyelinating
process, but revealed an “abnormal vascular flow in [the right] hemisphere including the occipital
lobe possibly concerning for a vasculitis.” Id. The attending neurologist added:
Acute onset weakness in tri-phasic illness with multiple lesions not severe
appearing in MRI. This is mostly consistent with an auto-immune reaction… She
had NMO [neuromyelitis optica] negative titers, but will need to follow up on this,
as this seems most likely. She is of Japanese descent, which also increases the risk
for NMO. For follow up and prognostic purposes, would also consider [lumbar
puncture] to get repeat titers and to get spinal MRI. Treat with pulse steroids with
taper. If she does not respond to this, would consider IVIg or PLEX.
Id. at 299.
K.N. thereafter had an infectious disease consultation on August 29, 2014 with Dr. Nicole
Learned, who noted that lab findings were not consistent with any particular infectious etiology,
and that instead a vasculitic or immune-modulated process was the more likely causal. Ex. 4 at
297.After improvement with steroid treatment, K.N. was discharged on September 5, 2014. Id. at
67.The discharge summary stated that a “very broad laboratory work-up has returned all negative
data,” and K.N.’s neurological function had improved such that she was “nearly back to baseline.”
Ex. 2 at 120; Ex. 4 at 67. Her diagnosis was left-sided weakness, and she remained on many
medications, including prednisone. Ex. 2 at 61, 77. K.N. also developed a urinary tract infection,
and antibiotics were prescribed. Id. at 77-78.
On September 11, 2014, K.N. saw Dr. Creig Hoyt, a neuro-ophthalmologist, who noted
that her “optic neuritis with edema of optic disc” had “completely resolved.” Ex. 4 at 1089.
Approximately one month later, on October 9, 2014, K.N. began outpatient physical therapy for
muscle weakness secondary to encephalitis. Ex. 3 at 213. The notes state that “[diagnosis] still
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under investigation but MD suspects viral infection, possibly from Tdap vaccine.” Id. at 222.
Fatigue and mild gait deviation were also observed. Id. at 215; see also Id. at 242-43, 258-59, 274-
75 (documenting additional sessions).
On October 13, 2014, K.N. was assessed at the University of California – San Francisco
pediatric multiple sclerosis (“MS”) clinic by Dr. Jennifer Graves. Ex. 2 at 176-92. Following a
thorough examination, K.N.’s treating physician concluded that her symptoms and response to
steroids in July 2014 were consistent with acute demyelinating ON. Id. at 191. The “second clinical
event occurred in the setting of 5-7 days of fever and has some features consistent and others less
consistent with a prolonged (20 [minute]) seizure and sequelae… She may have had an infectious
related encephalopathy.” Id. K.N. was instructed to complete the steroid taper and to follow-up
with the clinic; the recommendations also state to “[a]void live vaccines if possible, but vaccines
in the setting of prior optic neuritis can be evaluated with a risk benefit approach.” Id. at 192. The
record from this assessment also contains the first reference to K.M. testing positive for MOG
antibodies, although Dr. Graves only deemed their presence of “possible interest.” Id. at 191.
From October 29-31, 2014, K.N. was hospitalized at the University of California – San
Francisco following an episode of pain with eye movement and blurred vision. Ex. 2 at 203. K.N.’s
treating neurologist and rheumatologist concurred that her MRI imaging was “most consistent with
[a] vasculitic process, not MS.” Id. at 205. Upon discharge, K.N.’s working diagnosis was
“autoimmune [central nervous system] vasculitis.” Id.; Ex. 4 at 943.
K.N. continued to follow-up with numerous doctors, and on November 21, 2014, she was
evaluated by her rheumatologist for her “steroid-dependent [central nervous system] inflammatory
condition associated with abnormal MRI findings.” Ex. 2 at 228. Her vision had returned to
normal, but she still reported left-sided weakness with physical activity; she was participating in
physical therapy. Id. K.N. was tolerating her medications, and continued monitoring was
recommended. Id. at 228, 232.
Throughout 2015, K.N. had multiple appointments with various treating physicians. E.g.,
Ex. 4 at 1134-96, 1213, 1442. As of June 11, 2015, possible diagnoses included central nervous
system (“CNS”) vasculitis, MS with MOG antibodies of unclear significance, or NMO, although
the latter was deemed unlikely. Id. at 1183. K.N. continued to follow-up with neurology,
ophthalmology, gastroenterology, and rheumatology throughout 2016, 2017, and 2018. See, e.g.,
Ex. 34 at 244. She stopped taking immunosuppressant medication in January 2018, and in August
2018 was noted to be in remission, with migraine headaches and fatigue as remaining issues. Ex.
34 at 247, 269. In February 2019, the headaches that she was having were considered to be
unrelated to her “recurrent ON.” Ex. 35 at 31.
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On February 18, 2020, K.N. had a follow-up pediatric neurology visit. Ex. 36 at 5-13. The
record noted that K.N. had remained MOG antibody-positive 1/100 over the past two years, and
lab worked revealed that testing confirmed she remained positive that day as well. Id. at 5-13, 18.
II. Expert Testimony
A. Petitioner’s Expert – Dr. Robert Thompson Stone, M.D.
Dr. Stone, a pediatric neurologist, was Petitioner’s sole expert, and he both testified at
hearing and offered two written expert reports. Tr. at 4-54; Report, dated March 16, 2018, filed as
Ex. 11 (ECF No. 28-1) (“Stone Rep.”); Report, October 10, 2018, filed as Ex. 32 (ECF No. 35-1)
(“Stone Supp. Rep.”). Dr. Stone contended that it was more likely than not that the Tdap
vaccination K.N. received on June 7, 2014, caused the onset of MOGAD—manifesting as two
episodes of ON and one episode of ADEM-like illness. Stone Rep. at 10.
Dr. Stone obtained his medical degree from New York University School of Medicine, and
his residency training in Adult and Child Neurology at the University of Rochester School of
Medicine and Dentistry. Curriculum Vitae, filed as Ex. 11 on March 16, 2018 (ECF No. 28-1)
(“Stone CV”) at 2. He is licensed to practice medicine in the state of New York and board certified
in neurology with special qualifications in child neurology. Stone CV at 4. Dr. Stone was appointed
in 2011 to a faculty position as Assistant Professor in the Department of Neurology and Pediatrics
where he still currently serves. Id. at 2. He is also Director of the Rochester Pediatric Multiple
Sclerosis and Neuroimmunology Program. Id. Dr. Stone has authored numerous articles and
publications on various topics within the field of neurology and has received several grants for
neurological research. Id. at 4-5.
Dr. Stone began with an overview of MOGAD. As he explained, MOGAD is a CNS
inflammatory disorder that in recent years has been more fully described to be a distinct entity
from neuromyelitis optica (“NMO”), multiple sclerosis, and other acute demyelinating conditions
like ON or transverse myelitis (“TM”). Tr. at 16; First Stone Rep. at 7; E. Hennes et al., Prognostic
Relevance of MOG Antibodies in Children with an Acquired Demyelinating Syndrome, 89
Neurology 900-908 (2017), filed as Ex. 13 on Feb. 16, 2021 (ECF No. 74-1) (“Hennes”); Y.
Hacohen et al., Diagnostic Algorithm for Relapsing Acquired Demyelinating Syndromes in
Children, 89 Neurology 269-278 (2017), filed as Ex. 14 on Feb. 16, 2021 (ECF No. 74-2)
(“Hacohen”); Tr. at 13. MOGAD is associated with the presence of the anti-MOG antibodies.
Stone Rep. at 7. Those antibodies are thought to cause an attack on the MOG, or myelin
oligodendrocyte glycoprotein, a minor myelin protein expressed on the surface of the myelin
sheaths that wrap around the nerve cells. Tr. at 26.
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MOGAD manifests symptomatically as ADEM, ON,3 and/or TM, any of which could
constitute a singular and distinct disorder. Tr. at 41. Since MOGAD’s classification, however,
paitents presenting with ON and/or ADEM-like symptoms will now be tested for anti-MOG
antibodies. Id. Approximately sixty percent of children with MOGAD experience a monophasic
course, with the remainder suffering some symptoms relapse. Id. at 13-14. The risk of relapse is
higher in children who have not been immunosuppressed after the initial episode for at least three
months, with relapses occurring after immunosuppression (usually via corticosteroids) is ceased.
Id. at 14. Dr. Stone’s review of relevant literature revealed that it is common in patients with
MOGAD (even those whose course is self-limiting) to persistently test positive for the antibody—
with seventy percent of patients having persistent antibodies (although typically low titer) after the
condition goes into remission. Id. at 15.4
The cause of MOGAD is still currently unknown. It is understood that the target of the
autoimmune attack that results in the myelin destruction manifesting in CNS clinical symptoms
are the oligodendrocytes on the myelin surface, and that factors making MOGAD more likely
include gender and a genetic susceptibility. Tr. at 68-69. But much of what is known about
comparable acute/monophasic demyelinating conditions, like ADEM, could also be applicable. Id.
at 42. Indeed, Dr. Stone felt it likely that medical science had (before MOGAD was better
understood) likely misconstrued many cases of MOGAD as instead ADEM, which in the past was
not diagnosed with serologic tests. Id. at 66-67. But ADEM could have different causes and
pathologic paths—from a prior infection to the first manifestation of neuromyelitis optica spectrum
disorder (“NMOSD”), which is well understood to be propelled by a different autoantibody—
despite a common phenotype. Id. at 67-68.
Research has revealed that MOGAD has been around for quite some time, although it was
only recently proposed as a disease/condition entity. Tr. at 49. As a result, at the time of K.N.’s
inflammatory episodes (2014), her medical team unsurprisingly did not discern the diagnostic
importance of the positive MOG antibody finding that testing had revealed. Stone Rep. at 6; Ex. 2
at 191 (“[s]he has positive anti-MOG antibodies, and while these are of possible interest, a clear
syndrome involving these antibodies or treatment for such a syndrome have not been clearly
3 Dr. Stone described ON as inflammation of the optic nerve which can have a variety of causes (including idiopathic,
post-infectious, or post-vaccination), and can be a single event or the precursor/presenting symptom of a larger and
more chronic demyelinating disease, like multiple sclerosis or NMO Tr. at 16. ON leads to acute or subacute pain with
eye movement, vision loss, color desaturation, and decreased visual acuity on exam. Id.
4 At hearing, Dr. Stone also discussed how the difference in pathology between NMO spectrum disorder, a longer-
term and chronic condition, and the more acute/monophasic MOGAD is mirrored by the differences in treatment. Tr.
at 62. If NMO spectrum disorder is left untreated, many patients die within ten years or are left blind. Id. Modern
medicine has discovered the most effective treatment for NMO spectrum disorder is a medication called Rituximab.
Id. Patients treated with Rituximab, which depletes antibodies, see a far lower relapse risk. Id. In contrast, Rituximab
does not seem to be a particularly good treatment for MOG antibody disease. Id. at 63.
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defined in the literature). However, by the latter half of 2017, knowledge of MOGAD was
increasing, and commercial testing for the antibody became more widely available. Id.; Tr. at 13.
Dr. Stone reviewed a number of items of literature shedding light on the nature of
MOGAD. Stone Rep. at 6. Hacohen, for example, evaluated a cohort of 26 children who tested
positive for the anti-MOG antibody. Hacohen at 269. These children had initially presented with
what had appeared to be either an NMO spectrum disorder, multiphasic ADEM, or relapsing ON—
with 43.2% of these children presenting initially with ON (like K.N.). Hacohen at 273. 46.2% of
children with MRI abnormalities had “predominantly confluent, hazy/poor marginated lesions
involving both gray and white matter.” Id, at 274. Thus, MOGAD likely has some kind of impact
on the CNS (and the brain particularly) that has something to do with its varied presentation.
Another published report detailed the clinical presentation in MOGAD based on 252
patients found positive for the antibody. Stone Rep. at 7; M. Jurynczyk et al., Clinical Presentation
and Prognosis in MOG-Antibody Disease: a UK Study, 140 Brain 3128-3138 (2017), filed as Ex.
15 on Feb. 16, 2021 (ECF No. 74-3) (“Jurynczyk”). Jurynczyk observed that 55% of the studied
subjects presented with unilateral or bilateral ON, and 18% with ADEM or an “ADEM-like”
illness. Jurynczyk at 3128. In addition, 44% were relapsing, and 78% of patients had full or good
recovery in patients with ADEM-like or ON presentations. Id.
Review of K.N.’s medical history from July to October-November 2014 persuaded Dr.
Stone that she likely suffered from MOGAD. Stone Rep. at 2-6; Tr. at 15. Her first and third
inflammatory events (in July5 and October 2014, respectively) were consistent with ON, based on
her clinical findings, neuroimaging, and her treating physician’s impressions. Stone Rep. at 6. By
August, she began also to experience different recurring neurologic symptoms, plus fever and
fatigue, and cerebrospinal fluid (“CSF”) testing and MRIs both revealed the presence of
inflammation. Tr. at 18-19.
Dr. Stone acknowledged that this intervening set of symptoms proved to be a more
challenging assessment for her treating physicians, but it was nevertheless consistent with an
ADEM-like inflammatory event that in turn could constitute part of a MOGAD presentation. Stone
Rep. at 6. This was because the nature of these ADEM-like symptoms were not particularly
consistent with a monophasic case of classic ADEM, which would not typically follow ON, as
occurred in K.N.’s case. Tr. at 20. Its specific features herein, moreover—focal neurologic deficits,
including left hemiparesis, left facial weakness, and left visual field abnormality—were not
5 Dr. Stone commented on the July 29th record (Ex. 4 at 1086) in which a treater suggests that K.N.’s ON might not
be vaccine-related, testifying that he did not give great weight to the suggestion that the absence of cortical
leukoencephalopathy evidence made other etiologies, like a viral infection, more likely. TR 97-99. Ultimately, this
record comment is too vague and off-hand to give it significant evidentiary value—especially since a more holistic
and contextual consideration of the record (through at least October/November 2014) reveals that the true nature of
K.N.’s condition was not fully grasped at the time she received treatment for her initial ON symptoms.
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particularly consistent with classic ADEM.6 Stone Rep. at 7. K.N.’s MRI scan was also considered
atypical for ADEM, since it included gray matter lesions. MOGAD disease, by contrast, can
produce lesions involving both the gray and white matter. Id. at 7; Ex. 4 at 57.
Even before the second ON occurrence (and third event in total) , K.N.’s disease
progression continued, in Dr. Stone’s reading, to reflect something other than ON. A follow-up
MRI in September 2014 revealed “cellular swelling injury,” plus changes in cerebral blood flow,
all of which looked somewhat like a noninfectious inflammatory disease. Tr. at 19. K.N. also began
to display oligoclonal bands in CSF testing, an indicator of CNS inflammation. Id. At this point,
Dr. Stone deemed K.N.’s diagnosis to be “a bit elusive,” although the record pointed to “a single
process that was most likely consistent with an inflammatory or immune etiology.” Id. at 20.
Then, in October 2014, K.N. was seen by a pediatric neurologist, and at that time her
positive anti-MOG results were observed, along with new MRI scans showing resolution of signal
abnormalities (which Dr. Stone deemed “typical for ADEM”), plus decreased thickness of retinal
neurofiber, likely a function of her prior ON. Tr. at 22. Now (and in particular after her second
occurrence of ON), K.N. began to receive the kind of immunosuppressive treatment that in Dr.
Stone’s understanding would be appropriate in addressing injury attributable to the anti-MOG
antibody. Id. at 23. Indeed, Dr. Stone felt K.N. likely would have experienced more attacks after
October but for these treatments. Id. at 64-65. And in fact, her disease course was far less acute
thereafter (although Dr. Stone opined that the correct and effective treatment intervention made it
difficult to assess what would otherwise have befallen K.N. in the absence of treatment). Id. at 92.
Dr. Stone went on to discuss what is known about MOGAD’s potential association with
vaccination. Stone Rep. at 7. MOGAD is part of the spectrum of autoimmune, inflammatory CNS
demyelinating disorders, which also includes MS, TM, ON, ADEM, and NMO. Id. It is known by
medical science that both genetic and environmental factors contribute to developing such
conditions. Id. And recent infection or vaccinations (which mimic infectious processes) have been
clearly shown to trigger the onset of some of these disorders. Id.; see also E. Applebaum et al.,
Neurological Complications Following Antirabies Vaccination, 151(3) JAMA 188-191 (1953),
filed as Ex. 18 on Feb. 16, 2021 (ECF No. 74-6) (“Applebaum”); W. Huynh et al., Post-
Vaccination Encephalomyelitis: Literature Review and Illustrative Ca se, 15 J. Clinical
Neuroscience 1315-1322 (2008), filed as Ex. 20 on Feb. 16, 2021 (ECF No. 74-8) (“Huynh”).
For example, it was initially shown in 1953 that the Semple rabies vaccine had a strong
association with the development of ADEM. Stone Rep. at 7; Applebaum at 188. Since then,
ADEM has been found to be associated with multiple vaccines, including smallpox, MMR,
6 ADEM or ADEM-like inflammatory events typically feature initial non-specific symptoms like fever, headache, or
fatigue. Tr. at 20-22. Patients may also have polyfocal neurologic deficits, and an MRI scan usually shows bilateral
multifocal lesions. Id. at 22.
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Japanese B encephalitis, pertussis, influenza, and hepatitis B. Stone Rep. at 7; Huynh; D. Karussis
et al., The Spectrum of Post-Vaccination Inflammatory CNS Demyelinating Syndromes, 13
Autoimmunity Rev. 215-224 (2014), filed as Ex. 24 on Feb. 16, 2021 (ECF No. 75-2) (“Karussis”);
R. Baxter et al., Acute Demyelinating Events Following Vaccines: A Case-Centered Analysis,
63(11) Clinical Infectious Diseases 1456-62 (2016), filed as Ex. 21 on Feb. 16, 2021 (ECF No.
74-9) (“Baxter”). Baxter was particularly relevant, observing a statistically significant risk for
developing ADEM after the Tdap vaccine (based on >9 million subjects), with an odds ratio of
15.8. Baxter at 1456. While Dr. Stone acknowledged that Baxter’s findings were based on a small
sample, and that the frequency of vaccine-driven ADEM would have to be very uncommon, his
experience as a child neurologist and neuroimmunologist treating and managing children with
extremely rare diseases suggested to him that its findings still carried weight. Tr. at 70-72; Stone
Supp. Rep. at 2. ON is also commonly associated with vaccinations in the literature. Stone Rep. at
8; C. Ray et al., Bilateral Optic Neuropathy Associated with Influenza Vaccination, 16 J.
Neuroophthalmology, 182-184 (1996), filed as Ex. 25 on Feb. 16, 2021 (ECF No. 75-3).
Dr. Stone could not identify literature specifically associating MOGAD with vaccination.
At best, he referenced a single case report involving a boy who developed multi-phasic ADEM
(“MDEM”) associated with MOG antibodies after vaccination in the setting of a subclinical
infection. Stone Rep. at 8; K. Azumagawa et al., Post-Vaccination MDEM Associated with MOG
Antibody in a Subclinical Chlamydia Infected Boy, 38 Brain and Development 690-693 (2016),
filed as Ex. 28 on Feb. 16, 2021 (ECF No. 75-6) (“Azumagawa”); see also N. Kumar et al., Case
Report: Postvaccination Anti‐Myelin Oligodendrocyte Glycoprotein Neuromyelitis Optica
Spectrum Disorder: A Case Report and Literature Review of Postvaccination Demyelination,
22(2) Int. J. MS Care 85-90, filed as Ex. 37 on Feb. 16, 2020 (ECF No. 72-1) (“Kumar”) (37-year-
old woman presented with viral prodromal symptoms three weeks after receiving the tetanus
vaccine and two weeks after receiving the measles, mumps, and rubella and the varicella vaccines).
But Dr. Stone stressed that MOGAD’s novelty as a diagnostic category explained the
dearth of relevant literature studying it. Tr. at 34; Stone Rep. at 8. And he did not deem it
unreasonable to consider what was already known about comparable acute/monophasic
demyelinating conditions and their vaccine associations. It is well known that CNS demyelinating
diseases share certain characteristics with regard to their risk factors, pathophysiology, and
treatment strategies. Stone Supp. Rep. at 1. Thus, while neuroinflammatory autoimmune diseases
are not “interchangeable,” it is fair to make associations between conditions with similar
mechanisms. Id. This is especially the case given that such diseases are generally treated in a
common manner (i.e., with immunosuppression and/or steroids). Id. In addition, research has
revealed that forty to fifty percent of children previously diagnosed with ADEM actually likely
had MOGAD. Thus, reliance on literature regarding vaccine association with ADEM and ON is
fair, given the pathologic and symptomatic overlap for these related diseases. Tr. at 32.
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In addition, Dr. Stone maintained that some MOGAD-specific articles suggested a possible
vaccine association. S. Jarius et al., MOB-IgG in NMO and Related Disorders: A Multicenter Study
of 50 Patients, 13(280) J. Neuroinflamm. (2016) 1-45, filed as Ex. 32 Tab C on Feb. 16, 2021
(ECF No. 76-2) (“Jarius”). In Jarius, one out of fifty patients had disease onset of recurrent myelitis
and ON two weeks after receipt of a polyvalent vaccine against tetanus, diphtheria, and pertussis.
Tr. at 43; Jarius at 41. Although Jarius’s authors accepted that a causal link between the two events
could not be conclusively proven on this basis, “the close temporal association is highly suggestive
of vaccine-medicated immune activation.” Jarius at 41; Stone Supp. Rep. at 2. Moreov er,
symptoms started within two weeks after a polyvalent vaccination against tetanus, diphtheria, and
pertussis (as well as polio and influenza virus) in a second MOG-IgG positive patient in this cohort.
Id.
Dr. Stone also attempted to distinguish certain items of literature that Respondent’s expert
offered to rebut a MOGAD-vaccine association. One, a large-scale French study, looked at the
clinical and radiologic features of MOGAD in nearly 200 adults. A. Cobo-Calvo et al., Clinical
Spectrum and Prognostic Value of CNS MOG Autoimmunity in Adults, 90 Neurology 1858-1869
(2018), filed as Ex. 32 Tab A on Feb. 16, 2021 (ECF No. 76-1) (“Cobo-Calvo”). Dr. Stone,
however, noted that Cobo-Calvo did not involve children, and otherwise said nothing about
vaccine causality, as this was not the study’s intent. Stone Supp. Rep. at 1.
Dr. Stone further underscored the significance of patient age as a factor in associating
vaccination with MOGAD. Stone Rep. at 8. One recent study suggested that vaccination of any
type received by individuals younger than 50 years old was statistically associated with an
increased risk of CNS acute demyelinating syndromes. Id.; Tr. at 30; A. Langer-Gould et al.,
Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating
Disorders, 71(12) JAMA Neurology 1506-1513 (2014), filed as Ex. 27 on Feb. 16, 2021 (ECF No.
75-5), refiled as Ex. 32 Tab E on Oct. 10, 2018 (ECF No. 35-6) (“Langer-Gould”). Langer-Gould
specifically observed a two-fold increase in the first 30 days after vaccination—roughly the same
timeframe at issue for K.N. Stone Supp. Rep. at 2; Langer-Gould at 1506. MOGAD’s similarity
to other autoimmune CNS demyelinating conditions meant the same could be true here, in Dr.
Stone’s view, even though Langer-Gould could be read to apply only to demyelination associated
with more classically-monophasic conditions. Tr. at 81.
Besides a possible general association between MOGAD and vaccination, Dr. Stone
proposed two potential mechanisms to explain how K.N.’s vaccination could have initiated an
autoimmune inflammatory process. Stone Rep. at 8. First, he opined that molecular mimicry could
explain K.N.’s autoimmune inflammatory reaction. Id. He described molecular mimicry as
occurring where antigenic epitopes (i.e., pieces of a molecule in a vaccine or wild virus that can
induce an immune response) are similar or identical to a relevant CNS protein (here, MOG). Id.
Autoreactive immune cells induced by vaccine response could develop that can enter the CNS
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during routine immune surveillance and cause inflammation by reacting against homologous self-
targets. Id. at 8-9. The inflammatory response then leads to demyelination, and the clinical
symptoms of ADEM and ON. Id.; Tr. at 28; Huynh; R. Fujinami et al., Molecular Mimicry,
Bystander Activation, or Viral Persistence: Infections and Autoimmune Disease, 19(1) Clinical
Microbiology Reviews 80-94 (2006), filed as Ex. 29 on Feb. 16, 2021 (ECF No . 75-7)
(“Fujinami”).7 Alternatively, stimulation of preexisting anti-myelin-specific “bystander” T cells
already present in the body, but quiescent due to suppression by regulatory immune cells in an
effort to maintain tolerance to self, could be stimulated by the immune response elicited by
vaccination, which would then engage in an autoimmune reaction. Stone Rep. at 9; Tr. at 28;
Fujinami (modeling the experimental autoimmune encephalomyelitis model of MS).
Finally, Dr. Stone opined that the timing of K.N.’s MOGAD onset post-vaccination was
medically acceptable. Her first ON episode occurred approximately three weeks post-vaccination,
which he deemed typical for a vaccine-caused autoimmune CNS injury. Stone Rep. at 9; Tr. at 30;
A. Rowhani-Rahbar et al., Biologically Plausible and Evidence-Based Risk Intervals in
Immunization Safety Research, 31(1) Vaccine 271-277 (2012), filed as Ex. 31 on Feb. 16, 2021
(ECF No. 75-9) (neurological symptoms presenting in patients between six days and six weeks).
And he saw no other preceding incident to explain K.N.’s symptoms. Stone Rep. at 9; Tr. at 31.
K.N. had experienced no clear prior infection, for example, and the angiitis considered as
diagnostic for her second demyelinating episode could be ruled out, given that her recovery was
rapid with corticosteroids alone and there was significant resolution of the lesions on repeated MRI
imaging. Stone Rep. at 9.
B. Respondent’s Expert – Marc Albert Bouffard, M.D.
Dr. Bouffard, a neurologist with a specialty in neuro-ophthalmology, provided two written
reports and testified at hearing on behalf of Respondent. Tr. at 55-106; Report, dated July 12, 2018,
filed as Ex. A (ECF No. 33-1) (“Bouffard Rep.”); Report, March 5, 2019, filed as Ex. C (ECF No.
42-1) (“Bouffard Supp. Rep.”). Dr. Bouffard opined that it is more likely than not that the Tdap
vaccine did not cause K.N.’s MOGAD-related symptoms.
7 To support this argument, Dr. Stone cited literature involving T-cell mediated MS (see Stone Rep. at 8 n.18)—
despite the fact, as Respondent’s expert noted, that MOGAD is understood to be B cell mediated (since it is the anti-
MOG antibodies that drive the pathologic cross-reaction). Stone Supp. Rep. at 2. In response, Dr. Stone maintained
that denoting an autoimmune process as driven solely by B cells or T cells is overly simplistic, since (a) both interact
in an autoimmune process, and (b) literature suggests that molecular mimicry can arguably stimulate production of
either kind of immune cell. Id.; L. Albert, Molecular Mimicry and Autoimmunity, 34(27) New England J. of Med.
2068-2074, filed as Ex. 32 Tab F on Feb. 16, 2021 (ECF No. 76-3).
Respondent’s criticism of this component of Dr. Stone’s opinion is apt. This is amplified by the fact that Dr. Stone
lacks expertise in immunology (although that limitation in expert credentials is shared by Respondent’s expert).
However, and as discussed below, proof of mechanism is not required in vaccine cases generally, and I still find
preponderant evidence supports Petitioner’s “can cause” showing—even if mechanism itself was not well supported.
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Dr. Bouffard obtained his medical degree from Tufts University School of Medicine in
Boston, Massachusetts. Curriculum Vitae, filed as Ex. B on July 12, 2018 (ECF No. 33-14)
(“Bouffard CV”) at 1. He completed a neurology residency at Beth Israel Deaconess Medical
Center, a neuro-ophthalmology fellowship at the Massachusetts Eye and Ear Infirmary, and a
fellowship in Advanced General and Autoimmune Neurology at the Massachusetts General
Hospital. Bouffard CV at 1. Dr. Bouffard is licensed to practice medicine in the Commonwealth
of Massachusetts and is currently employed by the Harvard Faculty of Medical Physicians and
sees patients at the Beth Israel Deaconess Medical Center. Id. He routinely evaluates patients with
a variety of autoimmune disorders and currently treats a dozen patients with MOG antibody
associated disorders. Tr. at 57; Bouffard Rep. at 1. Dr. Bouffard has also published several articles
and book chapters in the field of neurology. Bouffard CV at 1-2.
Dr. Bouffard began with a review of MOGAD, which largely paralleled Dr. Stone’s
testimony. See generally Tr. at 59-61. He did not dispute the le gitimacy of MOGAD
diagnostically, and accepted the likelihood that K.N. had experienced it. Bouffard Rep. at 4; Tr. at
64. He emphasized that MOGAD is understood to involve specific antibodies, and thus B cells are
of primary importance in its pathogenesis. Bouffard Rep. at 5; Tr. at 53; L. Chen et al., Different
Features Between Pediatric-Onset and Adult-Onset Patients Who are Seropositive For MOG-
IGG: A Multicenter Study in Southern China, 321 J. Neuroimmunol. 83-91 (2018), filed as Ex. A
Tab 7 on July 12, 2018 (ECF No. 33-8) (“Chen”), at 89. But it remains unclear if the anti-MOG
antibodies are truly pathologic themselves. Tr. at 61; Karussis. At most, he speculated that the anti-
MOG antibody might influence the structural integrity of the target antigen, the oligodendrocyte,
which provides the fatty insulation around nerve axons that permits them to conduct electrical
signals from one place to another. Tr. at 61-62. Dr. Bouffard admitted, however, that recent
research about antibody-mediated diseases reveals they also involve abnormal function of “cell-
mediated” immunity, or T cells, in stimulating an inflammatory response. Id. at 53.
Dr. Bouffard noted some distinctions in MOGAD depending upon the age of the patient.
The constituent parts of the CNS impacted by MOGAD are similar for children and adults: the
optic nerve, the spinal cord, and/or brain. Tr. at 63. However, less than ten percent of adult cases
entail primarily an ADEM-like inflammation of the brain, while for children approximately fifty
percent do. Id.8 Otherwise the differences in adults and children with MOGAD were subtle (and
studies like Hacohen had relevance to pediatric cases). Bouffard Rep. at 4; Chen at 83.
8 Dr. Bouffard also testified that ADEM overall is more commonly monophasic when experienced by children,
although many children may subsequently experience chronic relapse or characteristic clusters of attacks when
treatments are suspended or limited. Tr. at 64.
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There is, however, in Dr. Bouffard’s view limited to no reliable evidence associating
vaccination and MOGAD’s initiation. Bouffard Rep. at 4.9 He noted, for example, a lack of
published epidemiologic data linking vaccines to MOGAD, adding that Dr. Stone seemed to accept
this absence of evidence as well. Id. at 4-5. Further, he rejected the notion that what was known
about other comparable neuroinflammatory conditions and illnesses could be applied herein,
arguing that such other diseases were not interchangeable with MOGAD. Thus, while it is believed
at the present that the anti-MOG antibodies central to MOGAD are likely pathogenic (as opposed
to the unexplained byproduct of the disease), the pathogenesis of comparable CNS demyelinating
conditions, such as ADEM, is far less understood, with no similar causative antibody having been
identified. Id.10 Indeed, Dr. Bouffard maintained that drawing a link between MOGAD and ADEM
was “particularly fraught,” noting that pediatric MOGAD cases who experience an ADEM-like
phenotype usually retain a progressive, relapsing course, whereas classic ADEM tends to be
monophasic, suggesting a fundamentally different mechanism by which both initiate and are
propagated. Bouffard Supp. Rep. at 2, 3.
Dr. Bouffard further opined that the scientific evidence connecting comparable
autoimmune neuroinflammatory diseases to vaccines was itself not especially robust, criticizing
some of the ADEM-oriented literature Dr. Stone offered. Bouffard Rep. at 5. Baxter, for example,
may have observed an increased incidence of post-Tdap ADEM, but this conclusion was based
only on the experience of two patients in total. Bouffard Rep. at 5; Baxter at 1456.11 Baxter’s
authors in fact disclaimed that their findings proved a causal link. Tr. at 70. And (since ADEM is
not per se interchangeable with MOGAD) Baxter’s findings were even less probative. Id. at 70-
72, 96. Langer-Gould’s observation of an increased risk of CNS demyelinating disease in the first
30 days following vaccination diminished in the subsequent timeframe, suggesting an absence of
long-term risk of disease—which in turn indicated to Dr. Bouffard that vaccination at best could
cause symptoms flare but not the underlying disease itself. Bouffard Rep. at 5; Langer-Gould at
1506.
9 Dr. Bouffard’s reports also both included lengthy sections where he addressed the “Hill criteria” for evaluating
scientific causation as a general matter. E.g., Bouffard Rep. at 6-7. Although interesting, this aspect of Dr. Bouffard’s
report revealed more about how he personally evaluated the persuasiveness of arguments regarding causation in this
case than their actual persuasiveness as a legal matter—a determination that I must make based on principles
applicable in Vaccine Program cases that are independent of the logical structures a given expert relies upon to decide
if the evidence for a causation is persuasive. I will therefore disregard these components of his opinion.
10 Dr. Bouffard also highlighted differences between NMO and MS to demonstrate the invalidity of applying
conclusions drawn from one disease to another. Bouffard Rep. at 5. NMO is understood to be mediated by the
aquaporin-4 antibody, whereas no pathologic antibody has ever been identified for MS. Id. In addition, the disease
processes for these two conditions vary for different populations, present differently, and require distinct treating
strategies. Id.; M. Jurynczyk et al., Overlapping CNS Inflammatory Disease: Differentiating Features of NMO and
MS, 86 J. Neurol. Neurosurg. Psychiatry 20-25 (2015), filed as Ex. A Tab 8 on July 12, 2018 (ECF No. 33-9).
11 On cross-examination, however, Dr. Bouffard admitted that Baxter’s findings regarding ADEM were statistically
significant. Tr. at 87.
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Other items of literature, Dr. Bouffard proposed, were no more supportive of Petitioner’s
theory. He acknowledged that studies like Cobo-Calvo or Hacohen did not seek to examine a
putative link between vaccination and MOGAD, but pointed out each included thorough chart
reviews of medical events antecedent to diagnosis—neither of which mentioned vaccines as a
likely cause. Bouffard Supp. Rep. at 1; Cobo-Calvo at 1862; Hacohen at 482. Jarius only observed
temporal vaccine associations to MOGAD, in circumstances with confounding facts such as
concurrent diseases. Jarius at 15, 26, 41, 42. Thus, Dr. Bouffard denied that “two cases of a
temporal association between rarely correlated events” was a sufficient basis for causation.
Bouffard Supp. Rep. at 2.
Dr. Bouffard also attempted to distinguished case reports cited by Dr. Stone. For example,
the Huynh case report involved ON after receipt of a flu vaccine—not Tdap—and discussed only
associations between ADEM and the flu vaccine. Huynh at 1315; Tr. at 35-36. The Cheong case
report also involved the flu vaccine and ADEM, and featured a patient with an identified
infection—a much more common trigger than vaccination. Tr. at 36-37. The Azumagawa case
report involved ADEM after a measles, mumps, and rubella (“MMR”) vaccination plus a Japanese
encephalopathy vaccine—again distinguishable from K.N.’s case. Azumagawa at 690; Tr. at 38.
And Kumar involved anti-MOG demyelination two and three weeks after MMR and tetanus
vaccination, respectively. Kumar at 85-86. Other case reports, like Applebaum, involve the rabies
vaccine, which contained brain tissue (an ingredient not included in Tdap), and hence “the
incidence of post-vaccination CNS demyelination was a lot higher” for reasons having to do with
the specific vaccine’s composition. Tr. at 25.
More specifically, Dr. Bouffard questioned the persuasiveness of Petitioner’s proposed
causation mechanism. In so doing, he reiterated his prior arguments about the problem of relying
on what is known about facially-comparable autoimmune CNS demyelinating diseases, observing
that because so little is known about most demyelinating conditions understood to involve
autoantibodies (whether NMO or MOGAD), it is difficult to delineate a coherent mechanism by
which the Tdap vaccine could specifically cause the production of the antibodies. Tr. at 61. Dr.
Bouffard also acknowledged the scientific legitimacy of molecular mimicry, but noted that the fact
that the anti-MOG antibodies might not drive the disease process diminished the utility of the
theory—especially since cross-reactivity featuring antibodies attacking homologous structures
would be the product of a B cell process. Id.; Tr. at 61.
Dr. Bouffard also considered K.N.’s actual medical history, but he did not seem to identify
much about it that suggested Dr. Stone’s causation theory was wrong. Bouffard Rep. at 1-3. He
deemed K.N.’s course to be “fairly typical for anti-MOG antibody mediated neuroinflammation.”
Id. at 4. Dr. Bouffard compared K.N.’s case to those described in Jarius, noting that clinically-
apparent attacks in these patients affected the optic nerve at some point for the majority of patients,
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consistent with what K.N. experienced. Jarius at 5. The response to steroids was also often marked,
as was K.N.’s case. Id.; Bouffard Rep. at 4. In addition, MRI brain abnormalities were common
and affected both the white matter and meninges, as seen in K.N. Jarius at 8; Bouffard Rep. at 4.
And he agreed that K.N.’s positive anti-MOG testing results would not have been understood in
2014 to have the same significance as today. Bouffard Rep. at 3.
Dr. Bouffard did, however, suggest that K.N.’s course—which featured three intervening
events separated by a few weeks—was not wholly consistent with the contention that the Tdap
vaccine caused upregulation of the anti-MOG antibodies. Even if vaccination could cause an initial
increase in antibodies, titer levels would likely drop once the effect of the vaccine’s initial immune
stimulation wore off, diminishing the likelihood of further attacks—as the record revealed
occurred here. Tr. at 75-76.
The timing of K.N.’s disease onset was not medically acceptable in Dr. Bouffard’s
estimation. Although he admitted that Langer-Gould observed a hi gher odds ratio f or
demyelinating injuries in 30 days after vaccination, he disputed whether the finding had statistical
significance, adding that because half of its of subjects had MS, with only one ADEM occurrence,
“it doesn’t translate to our patient’s disease” in this case. Tr. at 74.
Dr. Bouffard also proposed that there could be alternative explanations for K.N.’s
MOGAD—which, if potentially vaccine-caused, could be attributable as well to other “pathogenic
exposures.” Tr. at 78. He highlighted the fact that some of the case reports filed in this matter often
showed preexisting infection as confounding factor in development of a CNS autoimmune
inflammatory illness. Id. at 78-79. And he stressed that the record revealed K.N. had traveled
abroad prior to her vaccination, raising the possibility that K.N.’s travel could have constituted
sufficient antigenic stimulation to reduce the likelihood the vaccine was the instigating factor.
Bouffard Rep. at 6. She also had been exposed to family member with a reported upper respiratory
infection. TR at 79, 93-94. But Dr. Bouffard ultimately admitted that these alternatives were
speculative in nature, and could not be corroborated by record proof (for example, a test result
establishing the existence of a viral infection). Id. at 78, 93.
III. Procedural History
This matter commenced with the filing of the Petition on May 31, 2017 and was originally
assigned to Special Master Sanders. Over the following months, Petitioner filed medical records
in support of her claim. Respondent thereafter filed a Rule 4(c) Report on November 6, 2017
asserting that compensation was not appropriate in this case. Respondent’s Report, filed Nov. 6,
2017 (ECF No. 22). After the scheduling and canceling of a Rule 5 conference, Petitioner was
ordered to submit an expert report in support of her claim no later than February 14, 2018. See
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Docket Entry, dated Nov. 16, 2017. Following an extension, Petitioner subsequently filed expert
reports from Dr. Stone and accompanying medical literature on March 16, 2018.
Respondent filed a responsive report by Dr. Bouffard on July 12, 2018 along with literature
in opposition to Petitioner’s position. Petitioner filed an amended Petition on October 10, 2018.
After an interim fees motion, this matter was transferred to Special Master Danial Horner on
August 28, 2019. Both parties then filed supplemental expert reports. An Interim Fees Decision
was issued on September 9, 2019. The matter was reassigned to me on July 29, 2020, after which
I set it down for a hearing. A one-day entitlement hearing took place on March 16, 2021. The
parties elected to file post-hearing briefs, doing so on May 28, 2021. Petitioner’s Brief (ECF No.
86) (“Petitioner’s Post-Hearing Br.”); Respondent’s Brief (ECF No. 87). The matter is now fully
ripe for resolution.
IV. Applicable Law
A. Petitioner’s Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). In
this case, Petitioner does not assert a Table claim.
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, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation 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,
1352–53 (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 or by the opinion of a competent
physician. Section 13(a)(1).
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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 Hum. Servs., 418 F.3d 1274, 1278 (2005): “(1) a
medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause
and effect showing that the vaccination was the reason for the injury; and (3) a showing of
proximate temporal relationship between vaccination and injury.”
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
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.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. 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 essentially thorny 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.” Andreu, 569 F.3d 1367, 1380. Accordingly, special masters must take care not to
increase the burden placed on petitioners in offering a scientific theory linking vaccine to injury.
The Federal Circuit has consistently rejected the contention that the first Althen prong can
be satisfied merely by establishing a proposed causal theory’s scientific or medical plausibility.
See Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also
LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in
the past we have made clear that simply identifying a ‘plausible’ theory of causation is insufficient
for a petitioner to meet her burden of proof.” (citing Moberly, 592 F.3d at 1322)). Rather, this
prong (like the other two) requires a preponderant showing. This naturally flows from the
overarching fact that Program petitioners always have the ultimate burden of establishing their
claim with preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356
(Fed. Cir. 2013) (citations omitted); Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017) (noting
that Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under the
Vaccine Act” by a preponderance standard).
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,
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569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; 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 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).
Medical records and statements of a treating physician, however, 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 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); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,
2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review denied, 100 Fed.
Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 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 align 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, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. Appx. 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 rev. denied (Fed. Cl. Dec. 3,
2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
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B. Legal Standards Governing Factual Determinations
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. 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 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to 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 that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”), aff’d sub nom. Rickett v. Sec’y of Health
& Hum. Servs., 468 F. Appx. 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption
is based on the linked propositions 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); Cucuras v. Sec’y of Health & Hum. Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993
F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to
accurately report the onset of their daughter’s symptoms”).
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 Dep’t of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991) (citing United States
v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
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testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).
There are, however, situations in which compelling 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;
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, 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 often requires a petitioner to present
expert testimony in support of his 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 Pharmaceuticals,
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
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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 (such as the district courts). Daubert factors are usually
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. 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 the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742–45. 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.
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));
see also Isaac v. Sec’y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed.
Cl. Spec. Mstr. July 30, 2012), mot. for rev. denied, 108 Fed. Cl. 743 (2013), aff’d, 540 F. Appx.
999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of
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. Moberly, 592
F.3d at 1325–26 (“[a]ssessments as to the reliability of expert testimony often turn on credibility
determinations”); see also Porter v. Sec’y 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”).
Expert opinions based on unsupported facts may be given relatively little weight. See
Dobrydnev v. Sec’y of Health & Hum. Servs., 556 F. Appx. 976, 992–93 (Fed. Cir. 2014) (“[a]
doctor’s conclusion is only as good as the facts upon which it is based”) (citing Brooke Group Ltd.
v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993) (“[w]hen an expert assumes
facts that are not supported by a preponderance of the evidence, a finder of fact may properly reject
the expert’s opinion”)). Expert opinions that fail to address or are at odds with contemporaneous
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medical records may therefore be less persuasive than those which correspond to such records. See
Gerami v. Sec’y of Health & Hum. Servs., No. 12-442V, 2013 WL 5998109, at *4 (Fed. Cl. Spec.
Mstr. Oct. 11, 2013), aff’d, 127 Fed. Cl. 299 (2014).
D. Consideration of Medical Literature
Petitioner has filed medical and scientific literature in this case, but not every filed item
factors into the outcome of this decision. While I have reviewed all the medical literature submitted
in this case, I discuss only those articles that are most relevant to my determination and/or are
central to Petitioner’s case—just as I have not exhaustively discussed every individual medical
record filed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016)
(“[w]e generally presume that a special master considered the relevant record evidence even
though he does not explicitly reference such evidence in his decision”) (citation omitted); see also
Paterek v. Sec’y of Health & Hum. Servs., 527 F. Appx. 875, 884 (Fed. Cir. 2013) (“[f]inding
certain information not relevant does not lead to—and likely undermines—the conclusion that it
was not considered”).
E. Evaluation of Expert Credentials and Professional Competence
It is common in Program cases for special masters to evaluate competing expert opinions
when deciding non-Table claims—and that process can be very difficult when the experts are
equally well-credentialed and qualified to provide the opinion offered. Under such circumstances,
resolution of a claimant’s success in establishing causation turns on the comparative reliability of
the scientific/medical contentions each side makes, rather than a measure of each particular
expert’s baseline qualifications against the other. See, e.g., D'Tiole v. Sec'y of Health & Hum.
Servs., No. 15-085V, 2016 WL 7664475, at *20 (Fed. Cl. Nov. 28, 2016) (determination that
causation theory was unreliable did not arise from adequacy of Petitioner’s expert, who was
expressly deemed well-qualified to provide the opinion given), mot. for review den’d, 132 Fed. Cl.
421 (2017), aff'd, 726 F. App'x 809 (Fed. Cir. 2018).
In other circumstances, however, weighing the probative value of an expert’s opinion fairly
takes into account that same expert’s qualifications or professional experience. This is most
obviously necessary when an expert offers an opinion that plainly exceeds his training or
individual competence. Domeny v. Sec’y of Health & Hum. Servs., No. 94-1086V, 1999 WL
199059, at * 15 (Fed. Cl. Spec. Mstr. Mar. 15, 1999) (dentist not qualified to offer diagnostic
opinion on whether petitioner had experienced a neuropathy), mot. for review den’d, slip op., May
25, 1999 (Fed. Cl.), aff’d, 232 F.3d 912 (Fed. Cir. 2000). But it can even be an issue with experts
who possess immense and impressive credentials, and who in prior cases may have offered reliable
opinions. See, e.g., Rolshoven v. Sec'y of Health & Hum. Servs., No. 14-439V, 2018 WL 1124737,
at *21 (Fed. Cl. Spec. Mstr. Jan. 11, 2018) (otherwise-competent expert with significant Vaccine
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Program experience undermined his credibility in part with constant commentary about relevant
legal standards to be applied in case).
ANALYSIS
Petitioner Has Established Each of the Althen Prongs
A. Prong One
As described in detail above, a Program petitioner must show that the vaccine at issue “can
cause” the alleged injury, by proposing a scientifically and medically reliable causation theory.
Here, Dr. Stone offered his opinion as to causation, bulwarked with literature suggesting that
individuals at risk for developing MOGAD could have their disease process triggered or
accelerated by receiving a vaccination, and emphasized that comparable diseases in scope and
nature had been vaccine-associated. He also presented two possible mechanisms—molecular
mimicry and bystander activation—by which the Tdap vaccine could precipitate an autoimmune
response. Although Petitioner’s showing was far from robust, it was sufficiently preponderant to
carry her Althen prong one burden.
I begin with some discussion of other relevant decisions for guidance.12 I have not
identified cases in which a petitioner successfully demonstrated a vaccine triggered or caused
MOGAD—but this is probably attributable to the newness of the diagnostic classification, and
accompanying lack of literature/research on the topic—as both experts acknowledged to be the
case. Bouffard Rep. at 4; Stone Rep. at 7. Other petitioners have, however, successfully
demonstrated that the anti-MOG antibody was vaccine-induced, causing an individual to
experience a CNS demyelinating injury. See, e.g., White v. Sec’y of Health & Hum. Servs., No. 15-
1521V, 2019 WL 7563239 (Fed. Cl. Spec. Mstr. Dec. 19, 2019) (HPV vaccine caused anti-MOG
antibody-mediated TM). There is thus some recognition in the Program that vaccination could play
a role in the propagation of these antibodies, even if the greater disease itself has not previously
been evaluated in a reasoned decision.
12 It is certainly correct that prior decisions from different cases do not control my decision in this case. Only Federal
Circuit rulings concerning legal issues are generally binding on special masters in all cases. Guillory v. Sec’y of Health
& Hum. Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004). But it is reasonable, and in fact
prudent, when deciding a Vaccine Act case to consider and be guided by other relevant reasoned decisions involving
the same theory, injury, and/or vaccine. This flows from the fact that special masters reasonably draw upon their
experience in resolving Vaccine Act claims. Doe v. Sec’y of Health & Hum. Servs., 76 Fed. Cl. 328, 338–39 (2007)
(“[o]ne reason that proceedings are more expeditious in the hands of special masters is that the special masters have
the expertise and experience to know the type of information that is most probative of a claim”) (emphasis added).
They would therefore be remiss in ignoring prior cases presenting similar theories or factual circumstances, along
with the reasoning employed in reaching such decisions.
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There are, however, numerous reasoned decisions in which special masters determined that
a petitioner had successfully established that an acute and monophasic CNS demyelinating injury
was vaccine-caused—including due to the Tdap vaccine. See generally, Kennedy v. Sec'y of Health
& Hum. Servs., No. 09–474V, 2012 WL 1929801 (Fed. Cl. Spec. Mstr. May 8, 2012) (petitioner
who received the meningococcal and Tdap vaccines and then developed ADEM was entitled to
compensation based on the theory of molecular mimicry); Lerwick v. Sec'y of Health & Hum.
Servs., No. 06–847V, 2011 WL 4537874 (Fed. Cl. Spec. Mstr. Sept. 8, 2011) (ADEM and
DTaP/Hep B vaccines); Kuperus v. Sec'y of Health & Hum. Servs., No. 01–0060V, 2003 WL
22912885 (Fed. Cl. Spec. Mstr. Oct. 23, 2003) (awarding compensation in a DTaP/ADEM case
based on the theory of immune-mediated attack); Johnson v. Sec'y of Health & Hum. Servs., No.
99–0219V, 2000 WL 1141582 (Fed. Cl. Spec. Mstr. July 27, 2000) (ADEM and Tdap vaccine).13
I acknowledge Dr. Bouffard’s point that separate categories of CNS-demyelinating injuries
are not interchangeable—and that distinctions between them, particularly with respect to
pathology, often matter when evaluating causation .14 I nevertheless deem these prior
determinations helpful to the decision I must reach in this action. Dr. Stone persuasively
established that even if MOGAD featured more than one demyelinating incident (here, two flares
of ON with ADEM-like symptoms in the middle), it is likely (especially when experienced by
children) to feature a cluster of related demyelinating events, with greater relapse only likely if
prompt treatment does not arrest the overall disease process. Thus, although MOGAD may be
driven by a specific antibody distinct from whatever underlies the pathogenesis of a single
occurrence of TM or ON, Dr. Stone persuasively established that it is sufficiently akin to the CNS
demyelinating injuries that are more acute in nature to rely somewhat on what is known about
them for comparative purposes. Stone Rep. at 8; Tr. at 23-32. Indeed, certain instances of ADEM
diagnosed in the past may actually have constituted MOGAD. Tr. at 32.
13 By contrast, I have denied compensation in some recent cases alleging comparable acute demyelinating injuries
after the Tdap vaccine. See, e.g., I.J. v. Sec’y of Health & Hum. Servs., No. 16-864V, 2021 WL 1232733 (Fed. Cl.
Spec. Mstr. Jan. 4, 2021) (TM not caused by Tdap vaccine). However, I.J. is facially distinguishable. There, the
petitioner’s expert relied on Baxter, the same study cited herein—but despite the fact that Baxter expressly did not
find a statistically significant relationship between TM and the Tdap vaccine. Baxter is far more supportive of this
claim, since it did find an association between ADEM and Tdap (and ADEM is more comparable to some of K.N.’s
symptoms than TM).
14 I would particularly distinguish cases involving acute and monophasic CNS demyelinating diseases from those
where a chronic demyelinating injury, like MS, is experienced. I have generally not found that the latter are likely
vaccine-caused, since it cannot usually be reliably established that a vaccine would (alone or predominantly) set into
motion a chronic/relapsing disease process, with no predictable course or treatment that could stop it thereafter. See
Morgan v. Sec’y of Health & Hum. Servs., 148 Fed. Cl. 454, 466-67 (Fed. Cl. 2020) (citing Morgan v. Sec’y of Health
& Hum. Servs. No. 15-1137V, 2019 WL 7498665 at 16 (Fed. Cl. Spec. Mstr. Dec. 4, 2019)), aff’d, No. 2020-2107,
2021 WL 1115436 (Fed. Cir. Mar. 24, 2021). Self-limiting acute disease processes, by contrast, more credibly could
be attributed to a single vaccination event, which itself is self-limiting.
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With the foregoing as backdrop, Dr. Stone presented a persuasive theory that the Tdap
vaccine could cause MOGAD, by stimulating production of the anti-MOG antibodies. Tr. at 25,
46-47. These antibodies, in turn, cause CNS demyelination, which can present as ON or ADEM-
like episodes. Id. at 25-26, 47. Dr. Stone also proposed reliable mechanisms that could explain
MOGAD’s pathogenesis. Molecular mimicry and bystander activation have been accepted in other
Program cases as scientifically-accepted mechanistic explanations for the pr ogression of
comparable autoimmune-mediated demyelinating illnesses. Raymo v. Sec'y of Health & Hum.
Servs., No. 11–0654V, 2014 WL 1092274 (Fed. Cl. Spec. Mstr. Feb. 24, 2014), rev. den’d, aff’d
129 Fed.Cl. 691 (Fed. Cl. 2016).
Admittedly, Petitioner’s evidence regarding mechanism constituted a weak link in her
causation theory. Dr. Stone’s reliance on evidence relating to T cell-driven autoimmune processes
was inconsistent with the fact that MOGAD, as an antibody-oriented disease, would be B cell-
driven. Yet both experts in this case agreed that the relevant cross-reactive process herein is “more
complicated than simple amino acid sequence homology.” Tr. at 28-29, 77; Langer-Gould at 1511-
12 (“[v]accines could theoretically increase the risk of CNS ADS [acquired central nervous system
demyelinating syndromes] through mechanisms similar to those induced by infection. Infections
are known to cause or enhance autoimmunity through expansion of autoreactive T-cell clones by
molecular mimicry, later stimulation of autoreactive T-cell clones, or enhancement of antigen
presentation by bystander activation, epitope spreading, adjuvant effect, and enhanced antigen
presentation”). Dr. Stone in fact opined that MOGAD “isn’t purely a B-cell driven disease, but
there’s also abnormal function of cell-mediated immunity or T cells” (Tr. at 53), and that the
pathogenic nature of the anti-MOG autoantibody might only be exhibited in the presence of a T
cell-mediated inflammatory response. Tr. at 53-54 (citing Azumagawa at 690). This (plus the fact
that mechanism need not even be proved in a Vaccine Act case) leads me to find that the evidence
offered on potential MOGAD mechanisms stimulated by vaccination was adequately substantiated
(although barely so).
Respondent also raised valid arguments about the absence of more direct evidence
establishing that the Tdap vaccine co uld stimulate production of the MOGAD -related
autoantibodies. Tr. at 76-77. But I return to the fact that somewhat comparable acute demyelinating
CNS illnesses, like ON or ADEM, have been linked to the same vaccine—and, as Dr. Stone noted,
it is likely that up to forty or fifty percent of patients so previously diagnosed actually had
MOGAD. Tr. at 32. Since “the purpose of the Vaccine Act’s preponderance standard is to allow
the finding of causation in a field bereft of complete and direct proof [as to] how vaccines affect
the human body” (Althen at 1280), and given MOGAD’s diagnostic novelty, I do not find
Respondent’s objections in this case to causation merit the same weight they might receive in a
case involving a more-studied illness, or where more substantial rebutting evidence was offered.
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In sum, the evidence supporting Petitioner’s contention that the Tdap vaccine could be
causal of MOGAD is far from overwhelming. Certainly the limited science studying what is a
fairly recent diagnostic classification provides some explanation for this paucity—although I must
be careful in accepting such excuses, since all vaccine cases involve matters not fully understood
by medicine or science. Petitioners are still required to meet the preponderant burden of proof,
which is recognized to be substantial. Hodges v. Secretary of Health & Hum. Servs., 9 F.3d 958,
961 (Fed.Cir.1993) (while “the [Vaccine Act] does the heavy lifting” when a claimant seeks to
establish a Table injury, in the causation-in-fact context “the heavy lifting must be done by the
petitioner, and it is heavy indeed”). Nevertheless, Petitioner did persuasively establish through Dr.
Stone’s credible testimony that it may be scientifically correct to think of MOGAD as a refinement
and expansion on what was previously understood about related acute/monophasic illnesses like
TM or ADEM—injuries that are frequently compensated in the Program, via reasoned decisions.
I thus find that this is no worse than a “close” case—and such circumstances counsel for a
determination in the Petitioner’s favor on this prong of the Althen test. Andreu, 569 F.3d at 1378.
Of course, my determination leaves ample room for doubt—as indeed, any determination that a
claimant has carried his preponderant burden on the “can cause” prong is not akin to a finding that
a vaccine is medically certain to cause injury. As scientific understanding of MOGAD, and the
role that anti-MOG antibodies play in its pathogenesis, expands and develops, evidence far more
convincing than offered in this matter may come into existence suggesting that the Tdap vaccine
does not likely cause MOGAD. If such evidence is offered in a future case, it could well result in
a denial of entitlement. But Respondent did not so establish here, and/or rebut Petitioner’s
otherwise barely-preponderant showing herein.
B. Prong Two
The record in this case is generally consistent with the conclusion that the Tdap vaccine
likely caused K.N.’s MOGAD. Both experts agreed she had MOGAD. Stone Rep. at 6; Bouffard
Rep. at 4. K.N.’s course began with the onset of severe neurological symptoms approximately
three weeks after receipt of the Tdap vaccine. Tr. at 31. K.N. suffered from “frontal headaches”
approximately one week following vaccination, and then experienced an episode of optic neuritis
approximately three weeks post-vaccination, in July 2014. Id. at 16. MRI imaging showed
abnormal optic nerve enhancement plus swelling/edema which confirmed the existence of bilateral
optic neuritis. Id. at 17. There was no evidence of prior infection or illness to explain a possible
pathology, and testing was negative for antibodies associated with other CNS demyelinating
diseases. Id. at 16, 17, 19-20. Thus, these initial symptoms, leading up to what looked (at first) like
ON alone, are consistent with the conclusion that K.N. had begun experiencing an autoimmune
inflammatory process characteristic of MOGAD, even if she had not yet been tested for anti-MOG
antibodies (which as of 2014 were not understood to be as significant as they are today).
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K.N. was prescribed steroids and then prednisone which resulted in a good recovery of
vision and a subsequent steroidal taper by her treaters in August 2014. Tr. at 18. However, shortly
after the steroid taper, K.N. experienced recurrent neurological symptoms presenting as ADEM-
like inflammatory event and an episode of left optic neuritis. Although the second event proved to
be more of a diagnostic dilemma for her medical treaters, in retrospect was most likely an “ADEM-
like” event consistent with MOGAD. Stone Rep. at 7. Between the second and third event, testing
revealed K.N. was positive for MOG antibodies (although their significance was less understood
in 2014 than today). Tr. at 24-25. She later had a second bout with ON, and then steroid treatments
proved effective in arresting her disease course. Although K.N.’s overall course was not classically
monophasic (in that it featured a cluster of three related events within five months, rather than a
single event), Dr. Stone persuasively established that MOGAD’s kind of course often presents in
this way.
Petitioner’s medical treaters also documented the development of symptoms in the context
of vaccination on several occasions. For example, in a July 17, 2014 letter, Dr. Imes, a neuro-
ophthalmologist, wrote that K.N. “had a DTAP immunization a month earlier and an insect bite
the same day she told her parents she was having difficulty seeing.” Ex. 8 at 2. The next month,
on August 29, 2014, Dr. Von Scheven, a rheumatologist, wrote, “[i]mmunizations up to date; in
fact she received Tdap on 6/7 which was about a week before her symptoms of headache first
began.” Ex. 4 at 262. And on October 13, 2014, K.N.’s treating pediatric neurologist, Dr. Graves,
wrote:
Her first visual or neurological symptom[] was in July 2014…Before this episode,
June 7th she had a TDAP vaccine, she had frontal headaches around June 17th
while[e] on trip to France but no clear vision symptoms…Avoid live vaccines if
possible, but vaccines in the setting of prior optic neuritis can be evaluated with a
risk benefit approach.
Ex. 4 at 1090-1105. Such treater evidence also supports the conclusion that K.N.’s receipt of the
Tdap vaccine likely played a role in her subsequent symptoms.
C. Prong Three
The third Althen prong also finds support in the record, and the evidence of the timing for
symptoms onset is consistent with Petitioner’s causation theory. As Petitioner and her expert
established, an acceptable range of onset for immune-mediated CNS demyelinating reactions
triggered by vaccination is within thirty days/three to four weeks following vaccination. Tr. at 30;
Langer-Gould; Karussis. Here, Petitioner’s onset fell squarely within that range, since she
experienced her symptoms within one to three weeks after receiving the Tdap vaccine. Respondent
for his part did not establish that this timing was not medically acceptable or unreliable—in fact,
27

Case 1:17-vv-00722-MBH Document 95 Filed 08/17/21 Page 28 of 28
Respondent’s expert agreed at hearing that a three -to-four week onset was an appropr iate
timeframe for an immune-mediated reaction. Tr. at 94. I therefore find that Petitioner has offered
preponderant evidence in support of the conclusion that the timeframe for post-vaccination onset
of K.N.’s symptoms was medically acceptable.
CONCLUSION
Not nearly enough is currently known about MOGAD to say more definitively that it likely
can be, or cannot be, caused by vaccination. In a case with more evidence directly involving
MOGAD, I might well have determined that the causal association had not been demonstrated.
But a combination of Petitioner’s persuasive expert, apt analogies to recognized Program injuries,
and the general novelty of MOGAD from a diagnostic standpoint, all lead me to conclude that the
preponderant “line” was crossed herein—and thus that damages for K.N.’s vaccine-caused injury
are warranted.
In order to guide the parties through the damages phase of the action, a separate damages
order will issue.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
28

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DOCUMENT 2: USCOURTS-cofc-1_17-vv-00722-2
Date issued/filed: 2023-08-03
Pages: 12
Docket text: PUBLIC DECISION (Originally filed: 01/03/2023) regarding 116 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (saj) Service on parties made.
--------------------------------------------------------------------------------
Case 1:17-vv-00722-MBH Document 134 Filed 08/03/23 Page 1 of 12
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-722V
(not to be published)
* * * * * * * * * * * * * * * * * * * * * * * * *
*
K.N., *
*
Petitioner, * Filed: January 3, 2023
*
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, Petitioner
Naseem Kourosh, U.S. Dep’t of Justice, Washington, DC, Respondent.
DECISION AWARDING DAMAGES1
On May 31, 2017, Linda Chen filed a claim filed on behalf of her then-minor child,
K.N., for compensation pursuant to the National Vaccine Injury Compensation Program (the
“Vaccine Program”).2 K.N. became the named petitioner after she turned 18 years old. ECF
No. 114. The Petition alleged that K.N. suffered from a neurological demyelinating disorder as a
result of her receipt of a Tetanus-diphtheria-acellular pertussis (“Tdap”) vaccine on June 7,
2014. Petition (ECF No. 1) at 1.
1 Because this Decision contains a reasoned explanation for the action in this case, the undersigned is required to post
it on the United States Court of Federal Claims’ website in accordance with the E-Government Act of 2002. 44 U.S.C.
§ 3501 note (2012) (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, the undersigned agrees that the identified material fits within this
definition, the undersigned will redact such material from public access.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”).
All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.

Case 1:17-vv-00722-MBH Document 134 Filed 08/03/23 Page 2 of 12
I ruled in Petitioner’s favor on July 2, 2021. See Ruling, dated July 2, 2021 (ECF No. 88)
(“Ruling on Entitlement”). My ruling noted that Petitioner’s most-likely injury, based on the
record, was Myelin Oligodendrocyte Glycoprotein (“MOG”) Antibody Disease (“MOGAD”), a
neuroinflammatory condition. The parties could not come to an agreement on the proper quantum
of damages, and I therefore ordered them to brief their respective positions. See Petitioner’s Brief,
dated May 31, 2022. ECF No. 107 (“Br.”); Respondent’s Brief, dated July 29, 2022. ECF No. 110
(“Opp.”); Petitioner’s Reply, dated August 15, 2022. ECF No. 113 (“Reply”).
After review of the briefs and record, and for the reasons set forth below, I find that
Petitioner is entitled to an award of damages in the amount of $194,139.19, representing
$190,000.00 for actual pain and suffering, $2,190.00 for future unreimbursed expenses, and
$1,949.19 for past unreimbursed expenses.
I. Factual Background3
K.N. was born on 2004. Ex. 1 at 1. Prior to vaccination, she was a healthy
ten-year-old girl. See generally Ex. 2. On June 7, 2014, K.N. received the Tdap vaccine. Ex. 1 at
2; Ex. 2 at 9. Afterwards, K.N. traveled to France for a family vacation, during which time her
mother reported she experienced no medical issues. Ex. 3 at 24–26. Within a couple of weeks of
receiving the vaccine, however, Petitioner started complaining of headaches, and then at the
beginning of July began having problems with her vision. Ex. 10 at 2. On July 4, 2014, K.N.
woke up crying, telling her mother that she could not see anything. Id. K.N.’s mother therefore
rushed her daughter to the emergency room at the California Pacific Medical Center in San
Francisco, California. Id.
Emergency care treaters recorded K.N. as experiencing bilateral vision loss which had
started approximately two to three days earlier. Ex. 3 at 4, 24, 175. It was also noted that
K.N. a had a “recent sick contact” with her cousin, who had a fever, but K.N. had not felt ill
herself. Id. at 24. The results of a brain MRI showed “[s]uspected bilateral optic neuritis.” Id.
at 168. She received treatment with high-dose steroids, and on July 5, 2014, was transferred
out of the intensive care unit. Id. at 175. Her pediatric neurologist proposed K.N. had
acute disseminated encephalomyelitis (“ADEM”). Id. at 146.
K.N. remained hospitalized until July 7, 2014, and during that time her vision
improved following treatment with steroids. Ex. 3 at 5. Upon discharge, K.N.’s diagnosis was
parainfectious optic neuritis (“ON”), and her prognosis was deemed excellent. Id. On July 8,
2014, K.N. underwent a neuro-ophthalmology evaluation with Richard Imes, M.D. Ex. 2 at 50.
K.N.’s mother reported that her daughter “may have [had] a mild fever with a headache a
couple of weeks prior to losing [her] vision.” Id. K.N.’s optic disc swelling
3 In the interest of efficiency, I am summarizing herein relevant portions of the Ruling on Entitlement. ECF No. 88 at
2–5.
2

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had improved, and Dr. Imes recommended tapering her steroid treatment over the next ten
days. Id. He concluded that K.N. most likely had experienced ON “despite the vague history
of an antecedent viral illness… Post-immunization bilateral optic neuritis is well reported but not
after DTaP vaccine.” Id.
On July 23, 2014, K.N. had a follow-up appointment for her ON. Ex. 4 at 1083. Her
vision was 20/150 in her right eye and 20/200 in her left eye. Id. at 1084. The impression was
that K.N. had isolated papillitis bilaterally, and her treater noted it was “[v]ery unlikely to be
[multiple sclerosis] or other systemic pathology and ot [sic] related to recent vaccination as
no other cortical leukoencephalopathy [was] seen. This condition is thought to be post-viral.”
Id. at 1086. On July 29, 2014, K.N. visited ophthalmology for another follow-up and the
record noted that the “[p]atient feels like visual acuity improved…Medications: stopped
steroids 2 days ago… Assessment/plan: optic neuritis: Improving, now feels like visual acuity almost
back to baseline.” Ex. 8 at 1.
On August 26, 2014, K.N.’s pediatrician examined her for a recent headache with a fever
(which improved with ibuprofen) and vomiting. Ex. 2 at 8. K.N. also reported decreased
energy, but she denied eye pain or blurriness. Id. Two days later, on August 28, 2014, K.N.
presented to the emergency room at the University of California – San Francisco due to acute
onset left-sided “body shaking, numbness, and weakness.” Ex. 4 at 56. By this time, K.N.’s
ON had “nearly completely resolved.” Id. at 56–57. She was admitted to the pediatric
intensive care unit and underwent a lumbar puncture; the results were “concerning for
infection [versus] inflammatory process.” Id. at 57. An MRI angiography did not show signs
of a stroke, mass, or a demyelinating process, but revealed an “abnormal vascular flow in
[the right] hemisphere including the occipital lobe possibly concerning for a vasculitis.” Id.
The attending neurologist added:
Acute onset weakness in tri-phasic illness with multiple lesions not severe appearing in
MRI. This is mostly consistent with an auto-immune reaction… She had NMO
[neuromyelitis optica] negative titers, but will need to follow up on this, as this seems most
likely. She is of Japanese descent, which also increases the risk for NMO. For follow up
and prognostic purposes, would also consider [lumbar puncture] to get repeat titers and to
get spinal MRI. Treat with pulse steroids with taper. If she does not respond to this, would
consider IVIg or PLEX.
Id. at 299.
K.N. thereafter had an infectious disease consultation on August 29, 2014 with Dr.
Nicole Learned, who noted that lab findings were not consistent with any particular infectious
etiology, and that instead a vasculitic or immune-modulated process was the more likely causal.
3

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Ex. 4 at 297. After improvement with steroid treatment, K.N. was discharged on
September 5, 2014. Id. at 67. The discharge summary stated that a “very broad laboratory
work-up has returned all negative data,” and K.N.’s neurological function had improved such
that she was “nearly back to baseline.” Ex. 2 at 120; Ex. 4 at 67. Her diagnosis was left-
sided weakness, and she remained on many medications, including prednisone. Ex. 2 at 61,
77. K.N. also developed a urinary tract infection, and antibiotics were prescribed. Id. at 77–78.
On September 11, 2014, K.N. saw Dr. Creig Hoyt, a neuro-ophthalmologist, who noted
that her “optic neuritis with edema of optic disc” had “completely resolved.” Ex. 4 at 1089.
Approximately one month later, on October 9, 2014, K.N. began outpatient physical therapy
for muscle weakness secondary to encephalitis. Ex. 3 at 213. The notes state that
“[diagnosis] still under investigation but MD suspects viral infection, possibly from
Tdap vaccine.” Id. at 222. Fatigue and mild gait deviation were also observed. Id. at 215; see
also Id. at 242–43, 258–59, 274–75 (documenting additional sessions).
On October 13, 2014, K.N. was assessed at the University of California – San
Francisco pediatric multiple sclerosis (“MS”) clinic by Dr. Jennifer Graves. Ex. 2 at 176–
92. Following a thorough examination, K.N.’s treating physician concluded that her
symptoms and response to steroids in July 2014 were consistent with acute demyelinating ON.
Id. at 191. The “second clinical event occurred in the setting of 5-7 days of fever and has some
features consistent and others less consistent with a prolonged (20 [minute]) seizure and
sequelae… She may have had an infectious related encephalopathy.” Id. K.N. was instructed to
complete the steroid taper and to follow-up with the clinic; the recommendations also state to
“[a]void live vaccines if possible, but vaccines in the setting of prior optic neuritis can be
evaluated with a risk benefit approach.” Id. at 192. The record from this assessment also
contains the first reference to K.N. testing positive for MOG antibodies, although Dr.
Graves only deemed their presence of “possible interest.” Id. at 191.
From October 29-31, 2014, K.N. was hospitalized at the University of California – San
Francisco following an episode of pain with eye movement and blurred vision. Ex. 2 at 203.
K.N.’s treating neurologist and rheumatologist concurred that her MRI imaging was “most
consistent with [a] vasculitic process, not MS.” Id. at 205. Upon discharge, K.N.’s working
diagnosis was “autoimmune [central nervous system] vasculitis.” Id.; Ex. 4 at 943.
K.N. continued to follow-up with numerous doctors, and on November 21, 2014, she was
evaluated by her rheumatologist for her “steroid-dependent [central nervous system]
inflammatory condition associated with abnormal MRI findings.” Ex. 2 at 228. Her vision
had returned to normal, but she still reported left-sided weakness with physical activity; she
was participating in physical therapy. Id. K.N. was tolerating her medications, and continued
monitoring was recommended. Id. at 228, 232.
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Throughout 2015, K.N. had multiple appointments with various treating
physicians. See, e.g., Ex. 4 at 1134–96, 1213, 1442. As of June 11, 2015, possible
diagnoses included central nervous system (“CNS”) vasculitis, MS with MOG
antibodies of unclear significance, or neuromyelitis optica (“NMO”), although the latter was
deemed unlikely. Id. at 1183. K.N. continued to follow-up with neurology, ophthalmology,
gastroenterology, and rheumatology throughout 2016, 2017, and 2018. See, e.g., Ex. 34 at 244.
She stopped taking immunosuppressant medication in January 2018, and in August 2018 was
noted to be in remission, with migraine headaches and fatigue as remaining issues. Ex. 34 at
247, 269. In February 2019, the headaches that she was having were considered to be
unrelated to her “recurrent ON.” Ex. 35 at 31.
On February 18, 2020, K.N. had a follow-up pediatric neurology visit. Ex. 36 at 5–13.
The record noted that K.N. had remained MOG antibody-positive 1/100 over the past two
years, and lab worked revealed that testing confirmed she remained positive that day, as well.
Id. at 5–13, 18.
On March 15, 2022, at the age 18 years old, K.N. saw her neurologist, reporting that
she had been experiencing severe depression since before the pandemic, for which she had
missed the prior week of school, and that she had tried Lexapro, Zoloft (sertraline, an
anti-depressant), and Wellbutrin (bupropion, an anti-depressant). Ex. 40 at 67–68. K.N.
reported that she had not experienced visual symptoms or seizures in the previous two years, and
did not report any tingling, numbness, weakness, imbalance, or sphincter issues. Id. at 68. She had
not experienced migraines “in a while,” but had mild headaches twice a week. And
experienced some chronic fatigue. Id. The neurologist recommended that K.N. resume
taking magnesium and riboflavin to prevent headaches and migraines, continue seeing a
therapist and psychiatrist, and undergo another brain/orbit MRI. Id. at 74.
At a March 30, 2022 ophthalmology visit, K.N. underwent visual field testing, visual
evaluation, and optical coherence tomography. Ex. 40 at 76–77. The results showed normal and
stable distance and near card visual acuity, mild blue color deficits in the right eye, subtle
worsening of blue color perception in the left eye, preserved acuity, and generally stable retinal
nerve fiber layer and macular volumes with baseline low nerve fiber layer thickness since 2019.
Id.
On May 31, 2022, K.N.’s mother filed an affidavit stating that K.N.’s mental health has
been severely affected by her illness, and that she is being treated by a therapist and psychiatrist
for depression, anxiety, and post-traumatic stress disorder, but no additional medical
records were filed. Ex. 41 at 2–4.
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II. Legal Standards for Vaccine Program Damages Components
Compensation awarded pursuant to the Vaccine Act shall include “actual and projected
pain and suffering and emotional distress from the vaccine-related injury,” but only up to a capped
sum of $250,000.00. Section 15(a)(4). Additionally, a petitioner may recover “actual
unreimbursable expenses incurred before the date of judgment awarding such expenses which (i)
resulted from the vaccine-related injury for which the petitioner seeks compensation, (ii) were
incurred by or on behalf of the person who suffered such injury, and (iii) were for diagnosis,
medical or other remedial care, rehabilitation . . . determined to be reasonably necessary.” Section
15(a)(1)(B). The petitioner bears the burden of proof with respect to each element of compensation
requested. Brewer v. Sec’y of Health & Hum. Servs., No. 93-0092V, 1996 WL 147722, at *22-23
(Fed. Cl. Spec. Mstr. Mar. 18, 1996).
Determining the sum to be awarded for an injured party’s pain and suffering can be more
difficult than calculating other damages components, since there is no mathematic formula for
assigning a monetary value to a person’s pain and suffering/emotional distress. I.D. v. Sec’y of
Health & Hum. Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14,
2013); Stansfield v. Sec’y of Health & Hum. Servs., No. 93-0172V, 1996 WL 300594, at *3 (Fed.
Cl. Spec. Mstr. May 22, 1996) (“the assessment of pain and suffering is inherently a subjective
evaluation”). Factors to be considered when determining an award for pain and suffering include:
1) awareness of the injury; 2) severity of the injury; and 3) duration of the suffering. I.D., 2013
WL 2448125, at *9 (citing McAllister v. Sec’y of Health & Hum. Servs., No 91-1037V, 1993 WL
777030, at *3 (Fed. Cl. Spec. Mstr. Mar. 26, 1993), vacated and remanded on other grounds, 70
F.3d 1240 (Fed. Cir. 1995)).
I may also consider prior awards to aid my resolution of the appropriate amount of
compensation for pain and suffering in this case. See, e.g., Doe 34 v. Sec’y of Health & Hum.
Servs., 87 Fed. Cl. 758, 768 (2009) (finding that “there is nothing improper in the chief special
master’s decision to refer to damages for pain and suffering awarded in other cases as an aid in
determining the proper amount of damages in this case”). And of course I may rely on my own
experience adjudicating similar claims. Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961
(Fed. Cir. 1993) (noting that Congress contemplated that the special masters would use their
accumulated expertise in the field of vaccine injuries to judge the merits of individual claims).
Although pain and suffering in the past was often determined based on a continuum, as
Respondent argues, that practice was cast into doubt by the Court several years ago. See generally
Graves v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 579 (Fed. Cl. 2013). The Graves opinion
maintained that to do so resulted in “the forcing of all suffering awards into a global comparative
scale in which the individual petitioner’s suffering is compared to the most extreme cases and
reduced accordingly.” Id. at 589-90. Instead, Graves assessed pain and suffering by looking to the
6

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record evidence, prior pain and suffering awards within the Vaccine Program, and a survey of
similar injury claims outside of the Vaccine Program. Id. at 593-95. Under this alternative
approach, the statutory cap merely cuts off higher pain and suffering awards—it does not shrink
the magnitude of all possible awards as falling within a spectrum that ends at the cap. Graves is
not controlling of my determination herein, but it stands as a reasonable construction of the pain
and suffering cap.
III. Appropriate Compensation in this Matter
A. Pain and Suffering
In this case, awareness of the injury is not disputed. Even though Petitioner was a
child when her injury occurred, the affidavits provided by her mother establish that K.N. was
and continues to be aware of her condition. This leaves only the severity and duration
of Petitioner’s injury to be evaluated in calculating the pain and suffering component of
damages. When performing this analysis, I review the record as a whole to include the
medical records and affidavits filed and all assertions made by the parties in written documents.
Petitioner seeks $250,000.00 in pain and suffering. Br. at 77. K.N.’s medical records
and her mother’s affidavits provide descriptions of the pain and suffering she experienced
during the height of her illness, and what she continues to experience present day. In her
Motion, she cites to a damages decision involving MS—a chronic condition unlike the
acute and monophasic condition she experiences, but which she deems comparable
nevertheless due to the fear of relapse common to that claimant and herself. Hitt v. Sec'y of
Health & Hum. Servs., No. 15-1283V, 2021 WL 3598322, at *5–8 (Fed. Cl. Spec. Mstr. July
29, 2021) (awarding pain and suffering at the statutory cap amount of $250,000.00, based on
the determination that the total amount was higher).
In addition, Petitioner references a number of cases involving acute/monophasic injuries
like ON and ADEM that were resolved informally (and hence not via a reasoned decision) and
which resulted in pain and suffering awards of between $125,000.00 and $175,000.00. Br. at 74–
77; Hulett v. Sec'y of Health & Hum. Servs., No. 17-392V, 2018 WL 2772548 (Fed. Cl. Spec.
Mstr. May 14, 2018) (awarding $175,000); Boyer v. Sec'y of Health & Hum. Servs., No. 15-1160V,
2017 WL 2537371 (Fed. Cl. Spec. Mstr. May 18, 2017) (awarding $160,000); Smith v. Sec'y of
Health & Hum. Servs., No. 10-486V, 2012 WL 1131932 (Fed. Cl. Spec. Mstr. Feb. 28, 2012)
(awarding $125,000). She also cites to claims involving ADEM that were resolved informally
between the same range. See, e.g., Robinson v. Sec'y of Health & Hum. Servs., No. 19-2011V,
2021 WL 6067264 (Fed. Cl. Spec. Mstr. N ov. 15, 2021) (awarding $125,000 in pain and
suffering); Remmes Sec'y of Health & Hum. Servs., No. 19-736V, 2021 WL 5180239 (Fed. Cl.
Spec. Mstr. Oct. 14, 2021) (awarding $176,625). Petitioner argues that she is entitled to a larger
award, however, in light of the severity and length of her injury, and with consideration of her
7

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unique circumstances (young age of onset, ongoing visual decline, and likelihood of future pain).
Id. at 73–77.
In contrast, Respondent proposes the lesser sum of $125,000.00. Opp. at 1. He argues that
even if Petitioner continues to experience mild visual deficits (that were not noticeable and have
not caused a discernible impact on her vision), her other continuing symptoms are not sequelae of
her injury. Opp. at 16–17. Otherwise, Petitioner’s injuries were limited and have mostly resolved.
Id. at 16. Petitioner’s course included three hospitalizations (totaling 14 days) over the course of
three months and ten PT sessions, at which time she responded well to treatment and improved
rapidly. Id. at 16–17. And though Petitioner had several follow-up visits with providers in the
subsequent years, she has had no disease recurrences and suffered no major side effects of her
medication, and she remains stable and free of neurological symptoms after discontinuing
medications. Id.
In defending a lower sum, Respondent maintains that Hitt is distinguishable because of the
long-term, chronic character of MS, and its associated more-severe treatment course due to
associated flares (as were evident in the case of the Hitt injured party). Opp. at 21–22; Hitt,
2021 WL 3598322, at *2–3, 6. K.N.’s injury was far more acute, and resolved within a year
regardless of its subsequent sequelae and need for monitoring-oriented treatment. Opp. at 22.
Respondent also distinguished a case involving the more acute condition of NMO. Day v. Sec'y of
Health & Hum. Servs., No. 12-630V, 2016 WL 3457749, at *6–7 (Fed. Cl. Spec. Mstr. May 31,
2016), mot. for review den’d, 129 Fed. Cl. 450 (2016) (awarding $250,000.00). Respondent deems
NMO a “lifelong condition,” and the injured child therein had suffered numerous relapses and
required extensive treatment. Opp. at 23.
Respondent also observed that the stipulated or settled cases involving pain and suffering
awards in ON a nd ADEM cases were o f limited utility, since the reasonin g behind their
determinations could not be ascertained. Opp. at 23–24. By contrast, Respondent referenced a pain
and suffering determination from a c ase involving Guillain-Barré syndrome (“GBS”)—a
peripheral neuropathy that is largely distinguishable even if it also involves autoimmune-caused
nerve demyelination. Id. at 24–25, citing Day v. Sec’y of Health & Hum. Servs., No. 20-588, 2021
WL 5143925, at *1 (Fed. Cl. Spec. Mstr. Oct. 5. 2021). Day actually involved an award exceeding
what Respondent proposes ($175,000.00 rather than $125,000.00), but Respondent maintains that
Petitioner’s course herein was generally less severe. Opp. at 25.
After reviewing the record in this case and considering the parties’ arguments, I find that
the record best supports the conclusion that Petitioner suffered a somewhat moderate neurological
demyelinating injury—as far as that kind of injury goes (an important qualification). There is a
considerable lack of other comparable damages decisions from other ON and ADEM cases
(and I have not been able to identify a case specific to MOGAD, which likely explains K.N.’s
8

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injury). Ruling on Entitlement at 26. MOGAD appears to be mostly acute and monophasic in
nature, and arguably is a better explanation for clustering instances of TM, ON, and/or ADEM that
were observed in the past but understood to be distinct. Id. at 5–6, 12 (expert discussions of
MOGAD). Thus, and despite its alarming and acutely-presenting character, it is qualitatively
different from a longer-term demyelinating condition—whether CNS-oriented or impacting the
peripheral nervous system. In addition, the considerations that always impact a pain and suffering
award—length of hospitalization, degree and number of procedures for treatment, post-treatment
recovery, etc.— remain relevant.
I do not find that Petitioner’s preferred comparable in Hitt to provide compelling guidance
herein, since it involves MS, a far more alarming and long-lasting form of CNS injury.4 I also note
that the series of settled cases referenced by Petitioner all involve a lower range of award (albeit
in excess, for the most part, of what Respondent proposes). See generally Robinson, 2021 WL
6067264; Remmes, 2021 WL 5180239; Hulett, 2018 WL 2772548; Boyer, 2017 WL 2537371;
Smith v. Sec'y of Health & Hum. Servs., 2012 WL 1131932. While this “range” does not explicitly
govern the outcome herein (even less so since none of these are reasoned decisions), the cases that
create it collectively suggest that an award lower than what Petitioner seeks is more likely
appropriate.
A comparable determination that I deem somewhat helpful herein comes from a case
involving NMO suffered by a child. Day v. Sec'y of Health & Hum. Servs., No. 12-630V, 2015
WL 8028393, at *1, 4–5 (Fed. Cl. Spec. Mstr. Nov. 13, 2015).5 The injured child in Day presented
to the emergency room on numerous occasions—even three years after her diagnosis she was
hospitalized ten times in a single year. Id. at *4. Her symptoms included weight loss, fever,
irregular pupils, leg weakness and numbness, and the child’ mother repeatedly had to watch her
daughter relearn to walk several times. Id. If she stopped taking oral steroids, the child’s NMO
symptoms would return. Id. Overall, her illness made it difficult for her to have a normal life,
causing her to gain weight and rendering her unable to engage in her favorite sports and passions.
Id. $250,000.00 in pain and suffering was ultimately awarded. Day v. Sec'y of Health & Hum.
Servs., No. 12-630V, 2016 WL 3457749, at *6–7 (Fed. Cl. Spec. Mstr. May 31, 2016), mot. for
review den’d on other grounds, 129 Fed. Cl. 450 (2016).
K.N. was also a minor at the time of her vaccination—but her overall experience has not
been nearly as severe, even though more than minor pain and suffering has been
established. Br. at 55, 63–64. She endured hardship to obtain her diagnosis, presenting to
the
4 I also note that I have never determined that any vaccine can cause MS in the first place—further diminishing the
value of the damages determination from a contrary case.
5 As noted in the Ruling on Entitlement, NMO is a distinguishable condition, even if MOGAD and NMO are on the
same overall spectrum of autoimmune inflammatory CNS demyelinating disorders. Ruling on Entitlement at 5, 6 n.3,
8
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emergency room on three separate occasions (totaling 14 days) over the course of three months,
prolonged treatment with side effects, and ten PT sessions. Id. at 52–53, 56–60. Petitioner’s
sequelae included chronic weakness, loss of facial muscle control, pain, and chronic fatigue. Id.
at 1, 53–54. However, K.N.’s injury resolved, and she was able to stop taking her
immunosuppressant medication in January of 2018 and was noted to be in remission by August of
2018. Ex. 34 at 247, 269.
By March 2022 she reported that she had not experienced visual symptoms or seizures in
the past two years and did not report any additional sequalae from her injury. Ex. 40 at 67–68. In
that s ame month, results from a visual f ield test visual evaluation, and optical coherence
tomography showed normal and stable distance and near card visual acuity, mild blue color deficits
in the right eye, subtle worsening of blue color perception in the left eye, preserved acuity, and
generally stable retinal nerve fiber layer and macular volumes with baseline low nerve fiber layer
thickness since 2019. Ex. 40 at 76–77.
Not all of Petitioner’s post-injury symptoms can be shown to be related, however. Her
remaining issues of migraine headaches and fatigue were considered unrelated to her injury. Ex.
35 at 31. Petitioner argues that her medical condition has impacted her mental health leading to
depression, anxiety, and adjustment disorder. Br. at 61, 64–65, 68–70. Although I recognize the
difficulty in processing these events as a child, a relationship between Petitioner’s demyelinating
illness and her later mental health problems have not been substantiated, and the records that have
been filed do not establish that these mental health issues that arose in 2019 relate to her illness,
(which arose over five years after vaccination).
This is not to say that Petitioner has fully recovered from her injury and has no ongoing
sequelae. The record indicates a visual deficit that needs to be monitored, as addressed in
Petitioner’s request for future unreimbursed expenses. This impact of Petitioner’s vision is
documented but has not caused a discernible impact on her functional vision.
For these reasons, I find that Respondent’s proposal of $125,000.00 is far too modest, even
though I accept his argument that not all of Petitioner’s post-vaccination sequelae were
related. Respondent’s proposed figure fails to properly recognize K.N.’s experience with her
initial symptoms, diagnosis, hospitalization and treatment course for her injury, and the significant
impact on her life. Rather, the “best” pain and suffering sum to be awarded is substantially
higher, and more in keeping (if not in excess of) the range of determinations from the
stipulated results discussed above.
At the same time, however, Petitioner’s preferred sum is excessive under
the circumstances. K.N.’s residual symptoms that are attributable to her injury appear to be mild.
I also deem her “actual” pain and suffering to be less significant than in Day—and that her
10

Case 1:17-vv-00722-MBH Document 134 Filed 08/03/23 Page 11 of 12
future prognosis is not severe enough to so exceed the cap. Accordingly, balancing the severity of
the injury and Petitioner’s personal loss against the relatively moderate severity of disease course
and little follow-up treatment requirements, and considering the arguments presented by both
parties, a review of the cited cases, and based on the record as a whole, I find that $190,000.00 in
total compensation for actual/past pain and suffering is reasonable and appropriate in this case.
This figure is above the range of results discussed, as well as Respondent’s preferred comparable
from the later Day GBS case,6 but is more appropriate for a largely one-time injury that will not
likely recur or negatively progress.
B. Past Unreimbursed Expenses
The parties agree on the amount of $1,949.19 for past unreimbursed expenses. Br. at 49–
50; Opp. at 26 n.4. That sum is therefore adopted in this damages decision.
C. Future Unreimbursed Expenses
Petitioner also requests future costs in the amount of $30.00 per year (through age 26) for
the costs of annual neurology and ophthalmology visits, increasing to $50.00 per year thereafter
(from age 27 through 65 years old) for the costs of annual ophthalmology visits—$2,190.00 total.
Br. at 50–51; Reply at 6–8. Respondent maintains that Petitioner’s request was not previously
raised and is not supported by the evidence. Opp. at 26 n.4. I find that this damages component
has preponderantly been connected to Petitioner’s vaccine injury.
First, Petitioner has persuasively pointed to specific instances where future medical costs
were outlined within her settlement demand and communicated with Respondent’s former counsel
and forwarded to current counsel. Reply at 6. Second, the record reveals that Petitioner’s treaters
have routinely recommended regular follow-up visits with neurology and ophthalmology and
follow-up testing for her continuing visual deficits. Ex. 36 at 3–13; Ex. 40 at 67–74; Br. at 50–51;
Reply at 6–8. Petitioner also explained her expenses in detail by filing the average co-payment for
specialty visits from a leading healthcare provider, and thus has reasonably substantiated this
aspect of damages. Br. at 51, 85–91. Respondent did not sufficiently address this matter (but for
in a footnote) and did not file anything further to express his issues with the amount requested.
Accordingly, I find that Petitioner has established that these costs are reasonably associated with
her treatment; therefore, I find that Petitioner is entitled to compensation for future unreimbursed
medical expenses.
6 This Day case is not the same as the 2015-16 Day case involving NMO that I have referenced.
11

Case 1:17-vv-00722-MBH Document 134 Filed 08/03/23 Page 12 of 12
CONCLUSION
For all the reasons discussed above and based on consideration of the record as a whole, I
hereby award a lump sum of $194,139.19, in the form of a check payable to Petitioner,
reflecting the following:
• $190,000.00, representing an award of actual pain and suffering;
• $2,190.00, representing future unreimbursed expenses; and
• $1,949.19, representing past unreimbursed expenses.
These amounts represent compensation for all damages that would be available under
Section 15(a).
Absent a timely motion for review, the Clerk of Court is directed to enter judgment in
accordance with this Decision.7
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
7 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing
the right to seek review.
12

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_17-vv-00722-3
Date issued/filed: 2023-08-22
Pages: 22
Docket text: JUDGE VACCINE REPORTED ORDER (PUBLIC VERSION) re: 133 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Senior Judge Marian Blank Horn. (jm5) Service on parties made. Modified on 8/22/2023 to add case linkage (sw).
--------------------------------------------------------------------------------
Case 1:17-vv-00722-MBH Document 138 Filed 08/22/23 Page 1 of 22
In the United States Court of Federal Claims
No. 17-722V
Filed: August 2, 2023
Reissued for Publication: August 22, 20231
* * * * * * * * * * * * * * * *
K.N., *
*
Petitioner, *
v. *
*
SECRETARY OF THE DEPARTMENT *
OF HEALTH AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * *
Ronald C. Homer, Conway Homer, P.C., Boston, MA, for petitioner. With him was
Christina Ciampolillo, Conway Homer, P.C., Boston, MA.
Naseem Kourosh, Trial Attorney, Torts Branch, Washington, DC, for respondent.
With her were Lara A. Englund, Assistant Director, Torts Branch, Washington, DC,
Heather L. Pearlman, Deputy Director, Torts Branch, Washington, DC, C. Salvatore
D’Alessio, Director, Torts Branch, Washington, DC, Brian M. Boynton, Principal Deputy
Assistant Attorney General, all of the Civil Division, United States Department of Justice,
Washington, DC.
O R D E R
HORN, J.
The Motion for Review before this court was filed as a result of the denial by Chief
Special Master Brian Corcoran of the current petitioner’s request to redact her full name
to initials, redact her birth day and month, redact her mother’s full name to initials and
redact petitioner’s mental health diagnoses and prescription medications from the Chief
Special Master’s January 3, 2023 Decision Awarding Damages. In her Motion for Review,
unlike in previous Motions to Redact that petitioner had filed with the Chief Special Master,
petitioner did not request to redact petitioner’s mental health diagnoses and prescription
1 This Order was issued under seal on August 2, 2023. The parties did not propose any
redactions to the August 2, 2023 Order, and the court, therefore, issues the Order without
redactions for public distribution.

Case 1:17-vv-00722-MBH Document 138 Filed 08/22/23 Page 2 of 22
medications. Prior to the Motion for Review filed in this court, a number of unreported
orders and reported decisions had been issued in this case, as well as multiple Motions
to Redact filed before the Office of Special Masters.
On May 31, 2017, the original vaccine petition was filed with the Office of Special
Masters by the petitioner’s mother with the following caption: Linda Chen, parent of K.N.,
a minor v. Secretary of Health and Human Services, Case No. 17-722V. An amended
petition was filed on October 10, 2018, with the same case caption. The amended petition
alleged that the current petitioner had received a Tetanus-diphtheria-acellular pertussis
vaccination on June 7, 2014 and alleged that she suffered injuries as a result. The case
was originally assigned to Special Master Herbrina Sanders on June 1, 2017. On August
28, 2019, the case was reassigned to Special Master Daniel Horner. On September 23,
2019, a Decision Awarding Interim Attorneys’ Fees and Costs was issued as an
unreported decision by Special Master Horner, which reflected the mother’s name in the
case caption, but referred to the mother only as “petitioner” in the body of the decision
and referred to the current petitioner by her initials in the case caption and in the body of
the decision. See Chen v. Sec’y of Health & Hum. Servs., No. 17-722V, 2019 WL 5293486
(Fed. Cl. Spec. Mstr. Sept. 23, 2019). On July 30, 2020, the case was reassigned to Chief
Special Master Brian Corcoran.
Thereafter, on July 2, 2021, the Chief Special Master issued an Entitlement Ruling
in favor of the petitioner, with the caption L.C. v. Secretary of Health and Human Services,
No. 17-722V, 2021 WL 3630315 (Fed. Cl. Spec. Mstr. July 2, 2021). Subsequently, on
August 2, 2021, the Chief Special Master granted a Motion to Redact petitioner’s mother’s
name to initials, as well as granted the request to redact the still minor petitioner’s name
to initials whenever the names appeared in the July 2, 2021 Entitlement Ruling, including
in the case caption. In the Order Granting the Motion to Redact the Entitlement Ruling,
the Chief Special Master indicated that “[t]he Vaccine Rules make mandatory the
redaction of a minor’s name, but adult petitioners’ names (which are not similarly
protected automatically) may also be redacted if the movant establishes proper grounds
for so doing.” (alteration added). The Chief Special Master also stated:
Applying the relevant legal standards, Petitioner has sufficiently justified the
redaction of her name from the Decision. As is consistent with Vaccine
Program practice, K.N. has already had her name reduced to initials. Thus,
leaving Petitioner’s name unredacted would circumvent the benefit of the
minor name redaction in this case, especially given the unique nature of
medical harms alleged. The public purpose of the Vaccine Program is not
otherwise furthered by identifying the name of the Petitioner herein.
On May 31, 2022, petitioner filed a motion to amend the case caption, in which the
current petitioner indicated that she had turned eighteen, “making her the appropriate
petitioner rather than her mother.” This motion to amend the case caption also requested
that the “case caption refer only to her [the current petitioner] by initials,” (alteration
added), because, as indicated by petitioner,
2

Case 1:17-vv-00722-MBH Document 138 Filed 08/22/23 Page 3 of 22
[d]ue to the nature of K.N.’s injury, and that it specifically involves a
traumatic brain injury, petitioner remains concerned that publication of this
information could adversely affect K.N.’s future education and employment
opportunities. Additionally, in the event that pre-existing injuries will
influence private health insurance coverage in the future, petitioner is
concerned that publication of the details of K.N.’s injuries could adversely
affect her ability to obtain adequate and affordable coverage.
(alteration added; internal reference omitted).
On September 6, 2022, the Chief Special Master issued an order which granted
the current petitioner’s second request to redact and to change the case caption to reflect
the current petitioner’s name instead of her mother’s name because the current petitioner
had turned eighteen, but the Chief Special Master denied petitioner’s request for
redaction of her name from her full name to initials. The Chief Special Master found that
“redaction has not been shown to be appropriate” because “the concerns argued as
justifying redaction are far more speculative in nature,” than the concrete and tangible
concerns raised in other vaccine cases, without specifying which other vaccine cases.2
Regarding the petitioner’s request, the Chief Special Master also stated:
In the present matter, Petitioner argues that due to the nature of K.N.’s
injury, publication of the details concerning it and associated treatment
could adversely affect her ability to obtain adequate and affordable health
care coverage. Moreover, Petitioner asserts that if her name remains
discoverable, disclosure of such information would not only constitute an
unwarranted invasion of privacy but could greatly impact future education
and employment endeavors.
Citing W.C. v. Secretary of Health and Human Services, 100 Fed. Cl. 440 (2011) and
Langland v. Secretary of Health and Human Services, No. 07-36V, 2011 WL 802695
(Fed. Cl. Spec. Mstr. Feb. 3, 2011), two cases which provide guidance on how to interpret
the Vaccine Act’s direction to allow redaction of “medical files and similar files the
disclosure of which would constitute a clearly unwarranted invasion of privacy,” 42 U.S.C.
§ 300aa-12(d)(4)(B)(ii), the Chief Special Master stated:
While these justifications have logic, I find them to be somewhat speculative
at present—and thus not grounds for redaction, because the Petitioner has
failed to elucidate how she meets the W.C. or Langland standards. Rather,
the motion mainly relies on a naked assertion that Petitioner is concerned
that “if her full name were to remain on the case caption, a simple internet
search of her name will retrieve any Decision published to the Court’s
website” and that due to the unique nature of her injury, Petitioner remains
2 In his denial of the current petitioner’s request for redaction, the Chief Special Master,
in a footnote, cited the Vaccine Act, 42 U.S.C. § 300aa-12(d)(4)(B)(ii) (2018), which
provides that certain information may be redacted if its disclosure would constitute “a
clearly unwarranted invasion of privacy.”
3

Case 1:17-vv-00722-MBH Document 138 Filed 08/22/23 Page 4 of 22
concerned that publication of such information will constitute an
unwarranted invasion of privacy and adversely affect future opportunities.
But this assertion is true of literally every Vaccine Act litigant—and hence
proposes too broad, and thus easily met, a standard. I have allowed a
claimant’s name to be redacted to their initials when they can show a current
specific reason why the publication of their full name could harm them.
(emphasis in original; internal references omitted).
On January 3, 2023, the Chief Special Master issued his to be reported Decision
Awarding Damages with the caption using petitioner’s full name. The January 3, 2023
Decision Awarding Damages indicated:
Because this Decision contains a reasoned explanation for the action in this
case, the undersigned is required to post it on the United States Court of
Federal Claims’ website in accordance with the E-Government Act of 2002.
44 U.S.C. § 3501 note (2012) (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, the undersigned agrees
that the identified material fits within this definition, the undersigned will
redact such material from public access.
(emphasis in original).
On January 17, 2023, the current petitioner filed a third Motion to Redact with the
Chief Special Master, this time regarding the January 3, 2023 Decision Awarding
Damages. Petitioner requested:
• The Court redact her full name to her initials only (i.e. “K.N.”) in the case
caption, as well as the body of January 3, 2023 Decision Awarding
Damages;
• The Court redact petitioner’s mother’s full name to initials only (i.e.
“L.C.”) in the body of the January 3, 2023 Decision Awarding Damages;
• The Court redact petitioner’s birth date and month, leaving only the birth
year, in the body of January 3, 2023 Decision Awarding Damages; and,
• The Court redact reference to petitioner’s mental health diagnoses and
prescription medications prescribed to treat her mental health
diagnoses.
(capitalization in original).
4

Case 1:17-vv-00722-MBH Document 138 Filed 08/22/23 Page 5 of 22
In the third Motion to Redact, petitioner argued:
As an initial matter, petitioner’s injury involved a traumatic brain injury. If
petitioner’s full name remains discoverable, this could negatively impact her
future education, employment, career opportunities and access to
insurance, as an internet search could easily populate with the Court’s
Decision Awarding Damages. Similarly, because she intends to pursue a
career in scientific research, the public disclosure and easy identification of
her claim in the Vaccine Program could adversely affect her future by giving
the impression of anti-vaccination leanings on this politically divisive issue.
Petitioner’s injury occurred while she was a minor and her claim was filed
by her parents, on her behalf. As such, she did not overtly consent to the
filing of her claim and did not anticipate that her medical history would be
detailed in a Decision that could be published to the internet. Petitioner
remains concerned that the Court’s Decision Awarding Damages discusses
diagnoses and treatment for her mental health.
(capitalization in original; internal references omitted). According to petitioner’s third
Motion to Redact, she had entered college and intends to “pursue a career in the scientific
field, specifically scientific research focusing on microbiology, immunology and vaccines.”
On February 1, 2023, the Chief Special Master issued a roughly four-page Order
denying petitioner’s third Motion to Redact the January 3, 2023 Decision Awarding
Damages, of which approximately two pages contained the analysis of why the Chief
Special Master had denied petitioner’s redaction requests in full. In his February 1, 2023
Order, the Chief Special Master referenced his previous discussion of the W.C. case and
the Langland case in his September 6, 2022 Order on a motion to redact by the petitioner.
The Chief Special Master had found that petitioner had not sufficiently justified her most
recent, third request for redaction, and stated in his February 1, 2023 Order, he was
not ultimately persuaded that redaction is appropriate. I certainly find some
logic in Petitioner’s explanations for why she seeks redaction. However, she
has not made out a current, concrete specific interest that justifies
redaction—such as the fact that her employment is endangered by
publication of her name or the fact of involvement in this case.
(emphasis in original). The Chief Special Master further indicated that he considered the
current petitioner’s articulated concern about the impact of revealing her diagnoses and
medication as speculative and not warranting redaction as “a clearly unwarranted
invasion of privacy,” and that not including her name but using initials would create “some
administrative issues for the Court, and makes it more difficult to distinguish cases from
each other.”3
3 On February 28, 2023, following publication of the Decision Awarding Damages, initially
filed on January 3, 2023, but made available to the public on February 27, 2023, petitioner
filed an emergency motion to retract publication, which the Chief Special Master
temporarily granted on March 1, 2023.
5

Case 1:17-vv-00722-MBH Document 138 Filed 08/22/23 Page 6 of 22
On March 3, 2023, petitioner timely filed a Motion for Review of the Chief Special
Master’s February 1, 2023 denial of her request to redact the Chief Special Master’s
January 3, 2023 Decision Awarding Damages with this court, pursuant to the Vaccine
Act, 42 U.S.C § 300aa-12(e)(2), and the Motion for Review was assigned to the
undersigned Judge. In the Motion for Review currently before this court, petitioner only
requests that the court:
• Redact petitioner’s full name to her initials only (i.e. “K.N.”) in the case
caption, as well as the body of January 3, 2023 Decision Awarding
Damages;
• Redact petitioner’s mother’s full name to initials only (i.e. “L.C.”) in the
body of January 3, 2023 Decision Awarding Damages; and
• Redact petitioner’s birth date and month, leaving only the birth year, in
the body of the January 3, 2023 Decision Awarding Damages.
As noted above, unlike in previous Motions to Redact, the Motion for Review currently
before this court, does not include a request to redact reference to petitioner’s mental
health diagnoses and prescription medications prescribed to treat her and does not argue
that redaction is necessary to maintain access to health insurance.
After the filing of the Motion for Review currently under consideration by this court,
the government filed a response supporting the Chief Special Master’s denial of the third
Motion to Redact, arguing, “Petitioner has not shown that the Chief Special Master’s
denial of redaction was arbitrary, capricious, an abuse of discretion, or not in accordance
with law. Thus, the Chief Special Master’s Order should be affirmed.”
DISCUSSION
The Vaccine Act was designed to achieve a number of goals, including to offer a
user friendly forum for petitioners to pursue vaccine injury claims, build a history of usable
decisions for reference, and increase public awareness of vaccines and possible medical
conditions that have occurred after vaccination. See 42 U.S.C. § 300aa-10; W.C. v. Sec’y
of Health & Hum. Servs., 100 Fed. Cl. at 461. Underlying how to approach requests for
redaction is the general congressional intent that, in order to advance public health and
public awareness about vaccines, and to collect and disseminate information about
vaccines, including adverse reactions and injuries, Congress specifically required in the
Vaccine Act that Special Masters’ decisions generally be made available to the public.
See 42 U.S.C. § 300aa–12(d)(4)(B); see also N.B. v. Sec’y of Health & Hum. Servs., No.
20-151V, 2023 WL 167011, at *3 (Fed. Cl. Spec. Mstr. Jan. 12, 2023) (“The disclosure of
the additional information contained in the Fact Ruling is necessary to inform the public
of the type of injuries related to the vaccination.”); Windhorst v. Sec’y of Health & Hum.
Servs., No. 13-647V, 2017 WL 728045, at *5 (Fed. Cl. Spec. Mstr. Jan. 10, 2017)
(“Special masters have noted that in-depth decisions are necessary for the development
of the common law in Vaccine Act cases.”).
6

Case 1:17-vv-00722-MBH Document 138 Filed 08/22/23 Page 7 of 22
The Vaccine Act states:
A decision of a special master or the court in a proceeding shall be
disclosed, except that if the decision is to include information which are
medical files and similar files the disclosure of which would constitute a
clearly unwarranted invasion of privacy, and if the person who submitted
such information objects to the inclusion of such information in the decision,
the decision shall be disclosed without such information.
42 U.S.C. § 300aa-12(d)(4)(B)(ii). The Vaccine Act further states that “[w]ithin 30 days
after the Secretary receives service of any petition filed under section 300aa–11 of this
title the Secretary shall publish notice of such petition in the Federal Register.” 42 U.S.C.
§ 300a–12(b)(2) (alteration added). The Federal Register notice in petitioner’s case reads
in full: “Linda Chen on behalf of K.N., Boston, Massachusetts, Court of Federal Claims,
No. 17-0722V,” with no personal, medical, or prescription information included.
Also, pursuant to the Vaccine Act, the United States Court of Federal Claims
promulgated specific Vaccine Rules which govern practice in vaccine cases before the
court and before the Special Masters, including a rule regarding requests for redaction of
decisions issued by Special Masters and by Judges of this court. Vaccine Rule 18(b)
states:
A decision of the special master or judge will be held for 14 days to afford
each party an opportunity to object to the public disclosure of any
information furnished by that party:
(1) that is a trade secret or commercial or financial in
substance and is privileged or confidential; or
(2) that includes medical files or similar files, the disclosure
of which would constitute a clearly unwarranted invasion of
privacy.
An objecting party must provide the court with a proposed redacted version
of the decision. In the absence of an objection, the entire decision will be
made public.
Vaccine Rule 18(b) (2023) (emphasis in original).
In the Motion for Review currently before the court, petitioner has not specifically
asked for redaction of “trade secret or commercial or financial” information. See 42 U.S.C.
§ 300aa-12(d)(4)(B); Vaccine Rule 18(b). Rather, as indicated above, she only has
requested redaction of her “full name to her initials,” her “mother’s full name to initials,”
and “petitioner’s birth date and month, leaving only the birth year.” Although she had
previously requested redaction of “medical files or similar files” in front of the Chief Special
Master, the petitioner has not done so again in the Motion for Review currently under
review by this court.
7

Case 1:17-vv-00722-MBH Document 138 Filed 08/22/23 Page 8 of 22
The court also notes that Rule 5.2 of the Rules of the United States Court of
Federal Claims (RCFC), titled “Privacy Protection For Filings Made with the Court,”
instructs:
(a) Redacted Filings. Unless the court orders otherwise, in an electronic or
paper filing with the court that contains an individual’s social-security
number, taxpayer-identification number, or birth date, the name of an
individual known to be a minor, or a financial-account number, a party or
nonparty making the filing may include only:
(1) the last four digits of the social-security number and taxpayer-
identification number (see RCFC 9(m) when pleading a claim for a tax
refund);
(2) the year of the individual’s birth;
(3) the minor’s initials; and
(4) the last four digits of the financial-account number.
RCFC 5.2 (2023) (emphasis in original).
The Vaccine Act at 42 U.S.C. § 300aa-12(e)(2) provides that when reviewing a
Special Master’s decision, a Judge of the United States Court of Federal Claims shall:
(A) uphold the findings of fact and conclusions of law of the special master
and sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the special master
found to be arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law and issue its own findings of fact and conclusions of
law, or
(C) remand the petition [filed under § 300aa-11] to the special master for
further action in accordance with the court’s direction.
42 U.S.C. § 300aa-12(e)(2) (alteration added); see also Munn v. Sec’y of Health & Hum.
Servs., 970 F.2d 863, 867 (Fed. Cir. 1992); Civatte v. Sec’y of Health & Hum. Servs., 165
Fed. Cl. 520, 527 (2023) (“This court ‘may set aside the decision of a special master only
if the special master’s fact findings are arbitrary and capricious, its legal conclusions are
not in accordance with law, or its discretionary rulings are an abuse of discretion.’”
(quoting Turner v. Sec’y of Health & Hum. Servs., 268 F.3d 1334, 1337 (Fed. Cir. 2001));
Henkel v. Sec’y of Health & Hum. Servs., 165 Fed. Cl. 153, 157 (2023). As explained by
the United States Court of Appeals for the Federal Circuit:
With regard to both fact-findings and fact-based conclusions, the key
decision maker in the first instance is the special master. The Claims Court
owes these findings and conclusions by the special master great
deference—no change may be made absent first a determination that the
special master was “arbitrary and capricious.”
8

Case 1:17-vv-00722-MBH Document 138 Filed 08/22/23 Page 9 of 22
Munn v. Sec’y of Health & Hum. Servs., 970 F.2d at 870; see also 42 U.S.C. § 300aa-
12(e)(2)(B); Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir.
2011) (“We do 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—these are all matters within the purview of the fact finder.”
(citing Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1349 (Fed. Cir.
2010) (citing Munn v. Sec’y of Health & Hum. Servs., 970 F.2d at 871))).
Before this court is the petitioner’s Motion for Review of the Chief Special Master’s
February 1, 2023 Order Denying Petitioner’s Motion to Redact the January 3, 2023
Decision Awarding Damages. The Chief Special Master’s denial stated:
I am not ultimately persuaded that redaction is appropriate. I certainly find
some logic in Petitioner’s explanations for why she seeks redaction.
However, she has not made out a current, concrete specific interest that
justifies redaction—such as the fact that her employment is endangered by
publication of her name or the fact of involvement in this case. See, e.g.,
S.B. v. Sec’y of Health & Hum. Servs., No. 14-918V, slip op. (Fed. Cl. Spec.
Mstr. Feb. 9, 2016) (finding that petitioner had established that his
professional life could be negatively impacted by knowledge of his claim
and details relating to his medical treatment); K.L. v. Sec’y of Health & Hum.
Servs., No. 12-312V, 2015 WL 11882259 (Fed. Cl. Spec. Mstr. Oct. 30,
2015) (granting petitioner’s renewed motion for redaction because she
established that disclosure of her injuries would cause her harm in the
employment context).
(emphasis in original). The Chief Special Master also indicated that
the harm Petitioner envisions—that one day she may work in a science or
health care context—remains speculative and inchoate. Such
circumstances—where a claimant anticipates harm that does not emanate
from some demonstrated existing interest—have not been deemed
sufficient grounds to redact a claimant’s name from a Vaccine Program
opinion.
(emphasis in original). Moreover, according to the Chief Special Master, he did not
consider the petitioner’s articulated concerns about the impact of revealing her diagnoses
and medication to be “a clearly unwarranted invasion of privacy.”
In petitioner’s Motion for Review currently before this court, she argues that the
Chief Special Master improperly required her to show a “current, concrete specific interest
that justifies redaction.” (emphasis in original). Petitioner states:
While the Vaccine Act requires a petitioner to demonstrate a “clearly
unwarranted invasion of privacy” (§12(d)(4)(B)), and the US Supreme
Court, as adopted by the CFC [Court of Federal Claims], indicates the
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invasion of privacy becomes significant when personal information is linked
to individual identity (W.C., citing [United States Dep’t of State v. ]Ray[, 502
U.S. 164 (1991)]), Chief Special Master’s requirement that petitioner
demonstrate a “current and concrete” specific interest to justify redaction is
not in accordance with law. Indeed, nowhere in the Vaccine Act or caselaw
is a standard of “current and concrete” defined or designated as the
appropriate standard by which redaction is justified.
(emphasis in original; alterations added; internal references omitted).
Also in her Motion for Review currently before this court, petitioner articulates her
concerns as to the negative impact to petitioner of the availability of a published vaccine
decision which includes her name. Petitioner contends that if her full name is not redacted,
it will be easy to connect her case to her mental health diagnosis and treatment. Petitioner
states that “disclosure of her mental health conditions may adversely affect employment
opportunities,” including her future in the field of microbiology, immunology, and vaccines
because “anything that may suggest a connotation of an antivaccine sentiment (such as
a claim of vaccine injury) would be detrimental to my future goals.” Petitioner also argues
that her concerns are not “speculative and inchoate” as suggested by the Chief Special
Master, but that, “college serves as the foundation of an individual’s career, often
involving internships and networking that create a career.” (emphasis in original). In
further support, petitioner states she “has already spent time in scientific labs to further
her career.” Specifically, petitioner states in her Motion for Review:
First and foremost, the Court’s Damages Decision discusses a brain injury,
as well as mental health diagnoses and treatment. Damages Decision, page
5 (discussing “severe” depression, anxiety and post traumatic stress
disorder, as well as treatment with three (3) prescription medications) and
page 10 (discussing that depression, anxiety and adjustment disorder
appear to be unrelated to her vaccine injury). As petitioner explained,
“Mental health issues continue to carry a stigma in our society, and I do not
wish for such details, derived from private medical records, to be published
on the internet.”
(alteration added; internal reference omitted).4
4 As noted above, in the Motion for Review currently before this court, unlike in petitioner’s
previous Motions to Redact, although still concerned about making her medical
information public, petitioner only asks that her name and her mother’s name be redacted
to initials and that only her birth year be publishable, and not her birth date and month,
presumably so that it would be more difficult to connect petitioner with her medical
information in the future.
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In addition, petitioner argues before this court:
The Third Redaction Order denying redaction of the Damages Decision
cannot be reconciled with his [the Chief Special Master’s] First Redaction
Order granting redaction of the Entitlement Ruling. Approximately eighteen
(18) months elapsed between the First and Third Redaction Orders, during
which petitioner reached the age of majority, which serves as the only
change in circumstances upon which redaction was denied.
(alteration added). Petitioner argues that she “has demonstrated that the circumstances
of her claim justify redaction under governing law and legal guidance, but has also
demonstrated a specialized showing of harm that would result from disclosure of her
medical history and mental health history in connection with her identity.” Moreover, in
her Motion for Review, petitioner also argues that “the Chief Special Master’s denial of
redaction in petitioner’s case is inconsistent with his rulings in other recent cases.”
Respondent, however, argues that “petitioner fails to show any error by the Chief
Special Master in denying redaction.” Quoting Chief Special Master Corcoran’s February
1, 2023 Order Denying the Motion to Redact the January 3, 2023 Decision Awarding
Damages, respondent argues that “petitioner has identified no concrete, particularized
reason that publication of certain details regarding her medical history would constitute a
‘clearly unwarranted invasion of privacy.’” Further, respondent argues that “the Chief
Special Master considered petitioner’s arguments that publication could negatively impact
a future career in scientific research. But he found that the envisioned harm ‘remains
speculative and inchoate,’ as petitioner ‘anticipates harm that does not emanate from
some demonstrated existing interest.’” (emphasis in original). Citing the Chief Special
Master’s February 1, 2023 Order Denying Redaction of the January 3, 2023 Decision
Awarding Damages, respondent asserts “there is a significant Program interest in not
having every case caption in the Program reduced to initials.” Respondent, again quoting
the Chief Special Master, claims:
The Court now has a standard practice of redacting minors’ names to
initials, but the parents and/or guardians remain named, thus allowing for
intelligible identification of case precedent. Here, as noted, petitioner is no
longer a minor; thus, standard practice would be to include her name in the
case caption and the Damages Decision now that she is an adult. As the
Chief Special Master noted: “Redaction also creates some administrative
issues for the Court, and makes it more difficult to distinguish cases from
each other. It thus must be reserved for the limited cases where it is
demonstrably appropriate.”
By their very nature, cases brought under the Vaccine Act, filed with the Office of
Special Masters, involve personal and medical information. The court recognizes that
each different vaccine, when administered to different petitioners with different medical
histories, can result in individualized medical reactions and can require specific medical
treatment. Therefore, each case requires careful individualized analysis when ruling on
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entitlement, damages, fees, and redaction requests.5 Regarding redaction, the Vaccine
Act articulates a standard of “a clearly unwarranted invasion of privacy” to determine
whether or not to redact information when requested. See 42 U.S.C. § 300aa-
12(d)(4)(B)(ii).6 Furthermore, the Vaccine Rules contemplate a method for redactions as
Vaccine Rule 18(b) provides, in part: “A decision of the special master or judge will be
held for 14 days to afford each party an opportunity to object to the public disclosure of
any information furnished by that party. . . .” Vaccine Rule 18(b).
As indicated above, in his February 1, 2023 denial of petitioner’s request to redact
the January 3, 2023 Decision Awarding Damages, the Chief Special Master cited to a
number of earlier vaccine decisions. The Chief Special Master explained
it is important that special masters apply the standards set in Langland and
W.C. carefully when redaction is requested—and ensure that a sufficiently
specific showing has been made before allowing it. Redaction cannot be
treated as a secret, “off the menu” item that is readily provided to claimants
who know to ask for it, but denied to all others who fail to so move—even
though it is highly likely such claimants would also prefer the facts of their
specific case not be disclosed. Even though the relief sought by redaction
requests may seem quite minimal, and may not in most cases inhibit the
policy goals of publishing vaccine injury decisions, there must be some
standards applied when determining whether to grant it. If it is readily
5 The Chief Special Master himself recently recognized the individualized nature of
Vaccine Act cases, when considering a claim for the pain and suffering, the Chief Special
Master noted in footnote,
Respondent averred that Petitioner’s injury is comparatively less severe,
and thus, should not receive the statutory maximum. Nevertheless,
Respondent accepted Graves [v. Secretary of Health and Human Services,
109 Fed. Cl. 579 (2013)] “to the extent it calls for an individualized
assessment of damages based on the specific facts of a petitioner’s case,”
– which is in fact the proper the focus of the analysis.
Campbell v. Sec’y of Health & Hum. Servs., No. 20-381V, 2023 WL 1512589, at *5 (Fed.
Cl. Spec. Mstr. Feb. 3, 2023) (alteration added; internal citations omitted).
6 The court recognizes that the Vaccine Act directs that upon the filing of a petition, a
petitioner’s name generally is made public by including his or her name in the Federal
Register. This notice, as quoted above, however, is only a notice that a complaint has
been filed and this posting does not contain substantive medical information. See 42
U.S.C. § 300a-12(b)(2) (“Within 30 days after the Secretary receives service of any
petition filed under section 300aa–11 of this title the Secretary shall publish notice of such
petition in the Federal Register.”). As described above, the notice in petitioner’s case
stated in full: “Linda Chen on behalf of K.N., Boston, Massachusetts, Court of Federal
Claims, No. 17-0722V.”
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awarded on thin grounds, then the question is raised why all Program
petitioners do not receive it, as well.
(emphasis in original). Although the Chief Special Master cites both Langland and W.C.,
and their respective interpretations of the redaction standard in the Vaccine Act, 42 U.S.C.
§ 300a-12(d)(4)(B)(ii), the Chief Special Master’s February 1, 2023 Order denied the
current petitioner’s redaction request because she had not “made out a current, concrete
specific interest that justifies redaction,” (emphasis in original), which was not the
standard that was stated or applied in either Langland or in W.C.
In 2011, in W.C. v. Secretary of Health and Human Services, the Special Master
assigned to the case denied the motion to redact the petitioner’s name to initials, arguing
that there is a common law right to public access to judicial files. See W.C. v. Sec’y of
Health & Hum. Servs., 100 Fed. Cl. at 459–60. On a motion for review, the reviewing
United States Court of Federal Claims Judge found that the issue of redaction required
statutory interpretation of the Vaccine Act and, therefore, was subject to de novo review.
See id. at 457 (citing Hawkins v. United States, 469 F.3d 993, 1000 (Fed. Cir. 2006)). The
Judge’s decision in W.C. stated that the court “treats the issue of redaction as a question
of law with a relatively minimal attendant question of applying law to the facts.” Id. The
Judge in W.C. also compared the privacy provisions of the Vaccine Act to provisions in
the Freedom of Information Act (FOIA), 5 U.S.C. § 552(b)(6) (2006). See W.C. v. Sec’y
of Health & Hum. Servs., 100 Fed. Cl. at 458 (stating that the government must make
information publicly available except for “personnel and medical files and similar files the
disclosure of which would constitute a clearly unwarranted invasion of personal privacy”).
The Judge in W.C. further relied on the FOIA “balancing of interests” test in his decision,
stating, 5 U.S.C. § 552(b)(6) “requires the Court to balance ‘the individual’s right of
privacy’ against the basic policy of opening ‘agency action to the light of public scrutiny.’”
W.C. v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. at 459 (quoting United States Dep’t
of State v. Ray, 502 U.S. at 175). Not deferring to the Special Master’s decision, the
reviewing Judge in W.C. stated that the purposes of the Vaccine Act are not served by
requiring the petitioner’s name to be disclosed to the public and indicated that “[s]uch
disclosure may discourage potential petitioners from filing new cases, thus tending to
inhibit public awareness of vaccines and their risks.” Id. at 460 (alteration added).
Weighing the W.C. petitioner’s privacy interest against the public interest regarding
disclosure under the Vaccine Act, the Judge in W.C. reversed the Special Master’s denial
of the motion to redact, and redacted the petitioner’s name, who was not a minor when
his case was filed, to initials in the entitlement decision, and the Special Master’s decision
on redaction. See id. at 461.
Also in 2011, in Langland v. Secretary of Health and Human Services, a husband
and wife filed a petition on behalf of their minor child, who had received a vaccine. The
Langland Special Master indicated that Congress had conferred authority on the Special
Masters only to redact a specific subset of information as outlined in 42 U.S.C. § 300aa–
12(d)(4)(B)(i) and (ii), including information, which if disclosed, would constitute “a clearly
unwarranted invasion of privacy.” See Langland v. Sec’y of Health & Hum. Servs., 2011
WL 802695, at *6. According to the Langland Special Master’s decision:
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While Congress did not state explicitly in section 12(d)(4)(B)(ii) what it
intended by information which, if disclosed, would constitute a clearly
unwarranted invasion of privacy, “Congress does not legislate in a vacuum.”
Ortega v. Holder, 592 F.3d 738, 743 (7th Cir. 2009). Among other sources
of law, Congress legislates “against a backdrop that includes the decisional
law of the Supreme Court.” Hispanos Unidos v. Virgin Islands, 314 F. Supp.
2d 501, 504 (D. Vi. 2004) (citing Sea–Land Serv., Inc. v. United States, 874
F.2d 169 (3d Cir. 1989)). Thus, the privacy interests typically recognized by
federal courts provide guidance as to the meaning of the terms “clearly
unwarranted invasion of privacy.” The judiciary’s tradition of public access
to decisions, exemplified by its strict limitations on permitting filings under
seal, supports construing the Vaccine Act to restrict redaction.
Langland v. Sec’y of Health & Hum. Servs., 2011 WL 802695, at *7. The Langland Special
Master found that the petitioners had not satisfied the criteria for redaction of medical
information or made a special showing that disclosure was “clearly unwarranted.” See id.
at *8. The Langland Special Master also cited to the E-Government Act of 2002, Pub. L.
No. 107-347, 116 Stat. 2899 (2002), codified as amended at 44 U.S.C. § 3501 note
(2006). See Langland v. Sec’y of Health & Hum. Servs., 2011 WL 802695, at *2–3. The
Langland Special Master limited the scope of identifying information that should be
redacted to require a showing of “particularized harm outweighing the public interest in
disclosure,” id. at *8, as “consistent with the traditional presumption affording public
access to judicial actions and serves the Vaccine Act’s express purpose in promoting
public awareness of vaccine safety.” Langland v. Sec’y of Health & Hum. Servs., 2011
WL 802695, at *6; see also 42 U.S.C. § 300aa–12(d)(4)(b). The Langland Special Master
only partly granted the Langland petitioners’ request “by replacing the name of their minor
child with initials and redacting the child’s birth date,” see Langland v. Sec’y of Health &
Hum. Servs., 2011 WL 802695, at *11, but denied petitioner’s request to redact “‘any
other identifying information, such as case number, or name or location or medical
facilities or providers,’” and denied “redaction of any information that may have come from
or been part of any medical file, including any reference to a medical condition, disease,
or injury.” See id. at *2.
Petitioner in the above captioned case argues that both the approach taken by the
Special Master in Langland v. Secretary of Health and Human Services, 2011 WL
802695, and the approach taken by the Judge of the United States Court of Federal
Claims in W.C. v. Secretary of Health and Human Services, 100 Fed. Cl. 440, “can be
read in concert to support redaction in petitioner’s claim,” (emphasis in original), and that,
therefore, “Petitioner’s request for redaction satisfies the analyses in both Langland and
W.C.” With respect to the case of Langland v. Secretary of Health and Human Services,
as it applies to the case currently before this court, petitioner states:
Langland included redaction of the minor’s full name to initials and redaction
of the minor’s birthdate in the body of the Court’s Entitlement Ruling. In the
present case, petitioner’s vaccine injury occurred when she was ten (10)
years old, and her subsequent treatment continued throughout her
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adolescence. Her vaccine claim was pending in the Program from May 2017
through January 2023. Because the processing of her claim took almost six
(6) years to reach adjudication, she reached the age of majority. The privacy
afforded to minor petitioners in this Program should not be hastily cast aside
simply because the processing of the claim was protracted and the minor
reached the age of majority, especially when the injury and bulk of the
treatment occurred while petitioner remained a minor. Doing so essentially
renders any privacy afforded to minors null and void from the start.
(emphasis in original). Petitioner highlights in her Motion for Review, that the Judge in
W.C. “found that linking the disclosure of personal medical history with an individual’s
identity can constitute an unwarranted invasion of privacy, and therefore redacted the
petitioner’s full name to initials in order to satisfy both interest in individual privacy of
medical information and public disclosure of information surrounding vaccine injuries.”
The Chief Special Master’s February 1, 2023 Order, however, does not contain
meaningful analysis of the petitioner’s case as guided by Langland or W.C., nor other
relevant caselaw. The Chief Special Master’s February 1, 2023 Order rather notes that,
citing his September 6, 2022 Order Denying Redaction: “My prior redaction orders set
forth the general legal parameters governing redaction requests in the Vaccine Program,
and I incorporate them by reference herein.” The Chief Special Master stated in his prior
Order Denying Redaction in petitioner’s case, issued on September 6, 2022:
As I have noted in previous decisions concerning redaction, W.C. and
Langland set forth two somewhat-opposed interpretations of how strict the
standard for obtaining redaction should be. Applying the Langland standard,
special masters have held that a petitioner seeking redaction of a ruling or
decision must establish a “compelling reason, tailored to meet the individual
interest it serves”—a general preference for privacy is not enough, even if
reasonable in nature. Andrews v. Sec’y of Health & Human Servs., No. 08-
0396V, 2014 WL 3294656, at *5 (Fed. Cl. Spec. Mstr. June 4, 2014)
(quoting Langland, 2011 WL 802695, at *7–8). Based on the language of
the Vaccine Act itself, and the provisions in it discussing redaction, “a
petitioner requesting redaction of a decision must [] make an affirmative,
factual showing that redaction is proper” to prevail. See Castagna v. Sec’y
of Health & Human Servs., No. 99-411V, 2011 WL 4348135, at *10 (Fed.
Cl. Spec. Mstr. Aug. 25, 2011).
W.C., by contrast, emphasizes that a petitioner’s privacy interests should
be balanced against “the public purpose of the Vaccine Act” in the same
manner as such interests are balanced under the FOIA (given the
similarities of its privacy provisions). W.C., 100 Fed. Cl. at 460–61. In so
doing, “unwarranted” or “significant” invasions of privacy occasioned by
disclosure of sensitive information weigh in favor of redaction. Id. The
standard W.C. applies to redaction requests is thus somewhat more lenient,
as it asserts that the “right to access public records in civil cases” that
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counsels in favor of the disclosure of names and other sensitive information
need not be as carefully guarded in Vaccine Program cases, which are
statutorily intended to be more summary and less in adversarial nature. Id.
at 460. As W.C. reasons, because Vaccine Program decisions serve the
purpose of disseminating information about possibly adverse vaccine
reactions, disclosure of a petitioner’s name or information about her illness
is not always necessary to effectuate that purpose. Id.
(alteration in original). Although the previous September 6, 2022 Order provides more
explanation regarding the standards articulated in Langland and W.C., Chief Special
Master Corcoran did not fully apply the standard of either decision in his February 1, 2023
Order denying petitioner’s request to redact the January 3, 2023 Decision Awarding
Damages.
In the February 1, 2023 Order, the Chief Special Master also cited two of his own
prior decisions for support of his decision to deny the petitioner’s redaction request: S.B.
v. Secretary of Health and Human Services, No. 14-918V, which addressed a request for
redaction of a case caption prior to the public issuance of a decision, and K.L. v. Secretary
of Health and Human Services, 2015 WL 11882259, in which the Chief Special Master
addressed redaction of an Interim Fee Decision, as requiring a “current, concrete specific
interest that justifies redaction.” (emphasis in original).
In S.B. v. Secretary of Health and Human Services, Chief Special Master Corcoran
granted a request for redaction of the case caption, prior to the issuance of a decision.
The Order issued by Chief Special Master Corcoran granting the redaction stated in its
entirety:
On September 29, 2014, [petitioner] filed a petition seeking
compensation under the National Vaccine Injury Compensation Program.
Petitioner subsequently filed a motion to amend the case caption to reflect
only his initials (rather than his full name) on November 21, 2014.
Thereafter, on February 27, 2015, I issued an order denying Petitioner’s
motion on the grounds that the request was premature.
On March 13, 2015, Petitioner renewed his request to redact the
case caption, citing the potential adverse effect revealing his medical
information could have on his professional career (including future
employment opportunities). I discussed this request with the parties during
a status conference in this case on February 8, 2016. Respondent indicated
that she still believes that the request is premature, but she did not voice a
substantive objection.
Although no decision has yet issued in the case, the nature of the
facts alleged (as elucidated in Petitioner’s recent expert report) suggests to
me that it is appropriate to grant the leave sought by Petitioner. Accordingly,
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I have now agreed to amend the case caption to reflect only Petitioner’s
initials.
S.B. v. Sec’y of Health & Hum. Servs., No. 14-918V (alterations and emphasis added).
K.L. v. Secretary of Health and Human Services is the second of his own cases
cited by the Chief Special Master in his February 1, 2023 Order denying the current
petitioner’s request for redaction in the January 3, 2023 Decision Awarding Damages. In
K.L., the Chief Special Master originally denied redaction of an interim fees decision
because he found that petitioner K.L. had only asserted “in conclusory fashion that
disclosure in the Interim Fee Decision of her name and/or information about the illnesses
she alleges she has experienced after receipt of the HPV [Human Papillomavirus] vaccine
would constitute an unwarranted invasion of privacy.” K.L. v. Sec’y of Health & Hum.
Servs., 123 Fed. Cl. 497, 505 (2015) (alteration added).7 Thereafter, in an unpublished
decision, the Chief Special Master indicated that
7 In K.L. v. Secretary of Health and Human Services, after the Chief Special Master denied
the initial motion to redact the Interim Fees Decision, the K.L. petitioner filed a motion for
review which was assigned to the undersigned. At the time, the undersigned denied the
motion to review, stating that the Chief Special Master’s decision from an unpublished
interim fees decision, “cannot be determined to be obviously arbitrary and capricious.”
K.L. v. Sec’y of Health & Hum. Servs., 123 Fed. Cl. at 509. The undersigned, however,
explained:
If the undersigned had been the original reviewer of petitioner’s Interim
Petition for Attorney Fees and Costs, the court would not have included the
medical information the Special Master gratuitously inserted at the
beginning of his Interim Fees Decision, which denied the petitioner’s
request for such fees and costs. The medical information included by the
Special Master was not of any relevance to the reasoning offered in support
of his rejection of the interim fees and costs award.
Id. The undersigned also stated, at the time
Petitioner’s independent disclosure of her condition to her employer
suggests that she is responsible for managing her condition and weakens
her claim that her primary concern is that employers might find out from
public court documents that she has a medical condition. Moreover, the
Special Master left the door open in his Order denying the Motion for
Redaction and his Order denying the Motion for Reconsideration to a future
request to redact medical information or other information from the record
and future opinions, once the case has progressed further. The Special
Master explained his standard, stating that redaction may be appropriate if
petitioner offers a “particularized showing that her personal circumstances
or employment would cause the disclosure of such information to be more
invasive or harmful to her than to other Vaccine Program petitioners,” or
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Ms. L [K.L.] has now offered a second affidavit in an attempt to substantiate
why disclosure of those injuries in the Interim Fees Decision is harmful to
her, and it significantly strengthened her grounds for seeking redaction.
Accordingly, upon review of the information provided, I find that Ms. L’s
Supplemental Motion for Reconsideration remedies the deficiencies in her
argument that caused me to deny the original Redaction Motion (as well as
the Motion for Reconsideration). Ms. L has now demonstrated that the
Interim Fees Decision contains information the disclosure of which rises to
the level of an unwarranted invasion of privacy.
K.L. v. Sec’y of Health & Hum. Servs., 2015 WL 11882259, at *2 (alteration added;
internal reference omitted). In the January 3, 2023 Decision Awarding Damages, the
Chief Special Master stated that the standard for redaction was the “unwarranted invasion
of privacy” standard, however, in his February 1, 2023 Order denying redaction, the Chief
Special Master stated that the K.L. case had applied the “current, concrete specific
interest that justifies redaction” standard. (emphasis in the January 3, 2023 Decision
Awarding Damages).
As indicated above, in his February 1, 2023 Order denying petitioner’s Motion to
Redact the January 3, 2023 Decision Awarding Damages, the Chief Special Master
“after a substantive decision has been issued that discusses the petitioner’s
symptoms in sufficient detail to constitute a ‘clearly unwarranted’ invasion
of privacy.” (emphasis in original). Although the undersigned is not
convinced a comparative standard between petitioners, rather than a case-
by-case analysis, is appropriate, the Special Master did invite petitioner to
continue to more explicitly demonstrate any potential negative impacts on
her current or future circumstances at a later date in order to convince him
that all or part of the record warrants redaction. The undersigned also is not
convinced that waiting for a final entitlement decision is proper, if redaction
otherwise would be appropriate.
Id. at 508–09. Moreover, the undersigned indicated:
Although not directing the Special Master to redact his Interim Fees
Decision, the court strongly urges the Special Master to reconsider his
refusal to do so, and to consider redacting the medical information before
the Special Master’s Interim Fees Decision and related documents
submitted and decided as part of the Special Master’s consideration of the
Motion for Redaction and the Motion for Reconsideration are released to
the public, which, after investigation, it appears has not yet occurred.
Different considerations may or may not be relevant when the Special
Master issues a decision on the merits of petitioner’s case. This court
addresses only petitioner’s request with respect to the Special Master’s
Interim Fees Decision and subsequent litigation regarding that Decision.
Id. at 509.
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stated he “incorporated” by reference the legal reasoning from his earlier September 6,
2022 Order which also denied redaction of the current petitioner’s full name to initials in
the case caption. In the February 1, 2023 Order, the Chief Special Master denied the
current petitioner’s request because
she has not made out a current, concrete specific interest that justifies
redaction—such as the fact that her employment is endangered by
publication of her name or the fact of involvement in this case. See, e.g.,
S.B. v. Sec’y of Health & Hum. Servs., No. 14-918V, slip op. (Fed. Cl. Spec.
Mstr. Feb. 9, 2016) (finding that petitioner had established that his
professional life could be negatively impacted by knowledge of his claim
and details relating to his medical treatment); K.L. v. Sec’y of Health & Hum.
Servs., No. 12-312V, 2015 WL 11882259 (Fed. Cl. Spec. Mstr Oct. 30,
2015) (granting petitioner’s renewed motion for redaction because she
established that disclosure of her injuries would cause her harm in the
employment context).
(emphasis in original). The Chief Special Master did not state in the S.B. case or in the
K.L. case that the S.B. or K.L. petitioners had demonstrated a “current, concrete specific
interest that justifies redaction.” (emphasis in original). In fact, the indication that the Chief
Special Master adopted the “current, concrete specific interest that justifies redaction”
requirement in the S.B. case or the K.L. case is from the Chief Special Master’s own
subsequent orders denying the redaction requests by the current petitioner. (emphasis in
original). Moreover, the Chief Special Master did not provide details about what made
redaction appropriate or inappropriate in the S.B. case or in the K.L. case, or in his
redaction decisions regarding the current petitioner. Each request for redaction must be
made by applying the specifics in the case in which the redaction request is made, and
the Chief Special Master did not provide the necessary analysis regarding the current
petitioner to explain the specific circumstances which would make redaction inappropriate
in the above captioned case. In addition, both the S.B. and K.L. cases differ from the
current petitioner’s case insofar as the current petitioner was a minor when her case was
filed, during which time her name was redacted to initials, but she turned eighteen during
the pendency of her case, and the Chief Special Master denied redaction to the current
petitioner of her name thereafter. In contrast, both the S.B. and K.L. petitioners were not
minors when their cases were filed or decided.
The Chief Special Master also cited to certain additional decisions issued by other
Special Masters in his denial of the current petitioner’s redaction request, specifically
Jennings v. Secretary of Health and Human Services, No. 16-779V, 2020 WL 9259598
(Fed. Cl. Spec. Mstr. Sept. 15, 2020), and Anderson v. Secretary of Health and Human
Services, No. 8-396V, 2014 WL 3294656 (Fed. Cl. Spec. Mstr. Jun. 4, 2014), to argue
that the current petitioner’s stated harm “remains speculative and inchoate” and,
therefore, did not warrant redaction. In Jennings v. Secretary of Health and Human
Services, the assigned Special Master found that petitioner, who was a minor when the
case was filed, was not entitled to compensation due to receiving the HPV vaccination.
See Jennings v. Sec’y of Health & Hum. Servs., 2020 WL 925958, at *7. The Jennings
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petitioner requested that her medical records, which indicated that she had asthma, be
redacted because it would have a stigmatizing effect on her college applications and
potential employment, see id. at *3, the Special Master found insufficient justification for
redaction because “Asthma does not seem to be a condition that carries any social
stigma.” Id. at *7. The Jennings Special Master denied Ms. Jennings’ “request for a
redaction of her name to initials or to eliminate all reference to medical conditions.” Id.
Although cited by the Chief Special Master in his February 1, 2023 Order, the Jennings
v. Secretary of Health and Human Services case differs from the current petitioner’s case
because the possible employment harm alleged in Jennings was more remote than for
the current petitioner who stated in her redaction requests that she was already pursuing
a career in microbiology, immunology, and vaccines, and “has already spent time in
scientific labs to further her career.” Moreover, the Jennings petitioner sought redaction
of “medical information,” see id. at *1, and as described above, the current petitioner is
not requesting redaction of medical information in her pending Motion for Review and she
is now only requesting redaction of identifying personal information, including the full
name of herself and her mother, and of petitioner’s birth date and month.
In Anderson v. Secretary of Health and Human Services, 2014 WL 3294656,
petitioners, who brought suit on behalf of their minor child, sought “deletion of any item of
information that would link the identity of the petitioners to any personal medical,
educational or related information.” Id. at *1 (emphasis in original). The Anderson
petitioners argued that the request for redaction was “‘based primarily on their substantial
need to protect the privacy of their minor child.’” Id. at *4. The Anderson Special Master
found that “[r]ather than complying with the statute and establishing that the disclosure of
particular information would constitute a clearly unwarranted invasion of privacy,
petitioners assume they are entitled to protection from the disclosure of all educational
and medical information contained in my ruling.” Id. (alteration added). The Special
Master in Anderson v. Secretary of Health and Human Services denied the Andersons’
request for redaction because “they have failed to provide any specific reasons that the
information (already known to many third parties) would damage their child.” Id. at *8. The
Anderson case differs from petitioner’s redaction request currently under review because
the Special Master in Anderson relied on the fact that the information sought to be
redacted was “already known to many third parties,” see id., a fact which has not been
established in the current petitioner’s case and was not a basis for the Chief Special
Master to deny redaction in petitioner’s case. Notably, the entire reference to Anderson
in the Chief Special Master’s February 1, 2023 Order was: “Anderson v. Sec’y of Health
& Hum. Servs., No. 08-0396V, 2014 WL 3294656, at *9 (Fed. Cl. Spec. Mstr. June 4,
2014) (‘speculative harm is not sufficient to justify redaction under § 12(d)(4)(B)(ii)’).”
After review of the relevant statutes, rules, and cases, the information provided by
petitioner in her Motions to Redact filed with the Chief Special Master, and in her current
Motion for Review before this court, this court finds that, in the specific context of
petitioner’s case, there is limited public interest in the disclosure of this petitioner’s full
name or of the exact day and month of her birth, as previous orders and decisions in
petitioner’s case are not in the public domain with her full name and full birth date. The
current petitioner was a minor when the initial petition was filed by her mother on her
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behalf, and, therefore, at the time her full name automatically was redacted to only her
initials. As described above, the prior Entitlement Ruling published by the Chief Special
Master on July 2, 2021, solely referred to the current petitioner by her initials. Moreover,
in the Chief Special Master’s Order granting redactions in both the case caption and the
body of the Entitlement Ruling, the Chief Special Master indicated that “leaving
Petitioner’s name unredacted would circumvent the benefit of the minor name redaction
in this case, especially given the unique nature of medical harms alleged. The public
purpose of the Vaccine Program is not otherwise furthered by identifying the name of the
Petitioner herein.” It was inconsistent, arbitrary, and capricious given the facts of
petitioner’s case for the Chief Special Master now to include petitioner’s name, birth date
and month in his published decision, just because she reached the age of eighteen, during
the pendency of her case, especially given the extended length of the litigation, over six
years, and that petitioner’s name was redacted while she was a minor during most of the
litigation in the case. See C.F. v. Sec’y of Health & Hum. Servs., No. 15-731V, 2023 WL
2583513, at *2 (Fed. Cl. Spec. Mstr. Mar. 21, 2023) (“Petitioner raises several persuasive
points favoring her redaction request,” including “even though petitioner is now an adult,
the petition was initially filed at a time when she was a minor and she further stresses that
the medical history at issue is her childhood medical history, which in the ordinary course
would not be public. The Vaccine Rules generally provides [sic] for use of initials when
identifying a minor. Here, because this case was filed on her behalf as a minor, she should
not necessarily be held to the standard of anticipating at that time the ramifications of the
future medical disclosures threatened by publication of the decision ultimately resolving
this case.” (alteration added; internal references omitted)). Considering each of
petitioner’s requests included in her Motion for Review: using petitioner’s initials, and
redacting her birth date and month, when weighed against leaving the year of her birth,
as well as petitioner’s mental health diagnoses and petitioner’s prescription medications,
makes sufficient information available, and allowing the medical information to be
available to increase the body of vaccine information resulting in a balancing of the public
interests and petitioner’s interests in a fair and appropriate manner.
Therefore, given the applicable statutory and caselaw guidelines, as well as the
history and specific facts of petitioner’s case, and reviewing petitioner’s Motion for Review
of the February 1, 2023 Order Denying Petitioner’s Motion to Redact the January 3, 2023
Decision Awarding Damages, the court finds petitioner’s request to redact her name to
initials and to redact her birth date and birth month, but leaving her birth year, reasonable,
appropriate, and consistent with the history of her case, given petitioner’s chosen
professional field, balances the public’s interest, and avoids “a clearly unwarranted
invasion of privacy” in petitioner’s case. Granting petitioner’s more limited redaction
request in her Motion for Review also will allow the building of a searchable body of
caselaw to advise the public about vaccines, one of the aims of the Vaccine Act. See 42
U.S.C. § 300aa.
The court concludes, however, that, although inconsistent with the previous filings
and the Chief Special Master’s previous rulings, the Chief Special Master’s determination
not to redact petitioner’s mother’s name was not arbitrary and capricious as not “a clearly
unwarranted invasion of privacy,” 42 U.S.C. § 300aa-12(d)(4)(B)(ii), in the current
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petitioner’s case. Petitioner’s mother is not the petitioner, is an adult and was an adult
when she filed the petition, and she is not entitled to the same level of privacy protection
under the Vaccine Act. See Langland v. Sec’y of Health & Hum. Servs., 2011 WL 802695,
at *11. Moreover, as it relates to petitioner’s arguments for redaction of her mother’s name
to initials, petitioner’s mother’s full name, both first and last, is different from petitioner’s
full name, first and last, making it more unlikely for a current or potential employer of
petitioner, or for a researcher or reader, to connect the petitioner’s vaccine case history
to the current petitioner.
CONCLUSION
Petitioner’s Motion for Review of the Chief Special Master’s February 1, 2023
Order Denying petitioner’s Motion to Redact the January 3, 2023 Decision Awarding
Damages is GRANTED IN PART and DENIED IN PART. With respect to published
orders or decisions in petitioner’s case, including the January 3, 2023 Decision Awarding
Damages, petitioner’s name shall be redacted to her initials and reference to her date of
birth shall be limited only to her birth year. Petitioner’s mother’s name may remain
unredacted.
IT IS SO ORDERED.
s/Marian Blank Horn
MARIAN BLANK HORN
Judge
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