VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-00637
Package ID: USCOURTS-cofc-1_17-vv-00637
Petitioner: B.M.
Filed: 2017-05-15
Decided: 2025-07-25
Vaccine: ProQuad
Vaccination date: 2014-11-07
Condition: vasculitis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On May 15, 2017, Danielle Dotson, as the parent and natural guardian of her minor son B.M., filed a petition for compensation under the National Childhood Vaccine Injury Act. Ms. Dotson alleged that a ProQuad vaccine, specifically the varicella component administered on November 7, 2014, caused B.M. to develop vasculitis. B.M. was approximately 15 months old at the time of vaccination. Approximately three weeks later, on December 2, 2014, B.M. presented with fever and seizures and was hospitalized for about two weeks. During his hospitalization, physicians considered various diagnoses, including vasculitis and coronavirus infection, and B.M. underwent extensive testing. Despite these efforts, no definitive cause was identified, although coronavirus OC-43 was detected. B.M. was discharged and later readmitted, eventually receiving rehabilitation therapy. Ms. Dotson retained experts M. Eric Gershwin (rheumatologist/immunologist), David Wilson (radiologist), and Yuval Shafrir (pediatric neurologist) who opined that B.M. suffered from vasculitis and that the varicella vaccine caused it. The respondent, the Secretary of Health and Human Services, opposed the claim, retaining experts Michael Kruer (pediatric neurologist) and William Zucconi (radiologist), who opined that B.M. had viral encephalitis, not vasculitis, and that the varicella vaccine did not cause his condition. After extensive expert reports and briefing, Special Master Christian J. Moran issued a decision on January 31, 2025, denying entitlement. The Special Master assumed, for the sake of argument, that B.M. had vasculitis but found that Ms. Dotson failed to establish a medical theory causally connecting the varicella vaccine to the injury, a requirement under the first prong of the Althen test for off-Table claims. The Special Master noted deficiencies in the petitioner's expert reports, including a lack of clarity regarding the theory of causation and reliance on unreliable data sources like VAERS. The Special Master concluded that Ms. Dotson did not meet her burden of proof. On review, Judge Robin M. Meriweather of the U.S. Court of Federal Claims affirmed the Special Master's decision on July 25, 2025, finding that the Special Master's findings were not arbitrary and capricious and that Ms. Dotson failed to establish causation in fact. Entitlement to compensation was denied.

Theory of causation field:
ProQuad vaccine, particularly the varicella component, on November 7, 2014, age about 15 months, followed about 25 days later by fever, seizures, hospitalization, and alleged vasculitis. DENIED. Petitioner Danielle Dotson relied on Dr. M. Eric Gershwin and theories including molecular mimicry, immune complexes, and cytokines; respondent disputed diagnosis and causation and emphasized coronavirus OC-43 and lack of reliable vaccine-vasculitis proof. Special Master Moran dismissed the petition January 10, 2025, and Judge Robin M. Meriweather affirmed July 25, 2025. No injury compensation awarded.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_17-vv-00637-1
Date issued/filed: 2025-01-31
Pages: 48
Docket text: PUBLIC DECISION (Originally filed: 01/10/2025) regarding 194 DECISION of Special Master. Signed by Special Master Christian J. Moran. (jjb) Service on parties made.
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Case 1:17-vv-00637-RMM Document 195 Filed 01/31/25 Page 1 of 48
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
DANIELLE DOTSON, as parent and *
natural guardian of B.M., a minor, * No. 17-637V
*
Petitioner, * Special Master Christian J. Moran
*
v. *
* Filed: January 10, 2025
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * *
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner;
Naseem Kourosh, United States Dep’t of Justice, Washington, DC, for respondent.
DECISION DENYING ENTITLEMENT1
Danielle Dotson alleges a ProQuad vaccine (specifically the varicella
portion) harmed her son, B.M. The basic chronology is that B.M. was vaccinated
and approximately three weeks later, developed a severe neurologic problem for
with he was hospitalized for about two weeks.
While he was being treated, the doctors did not reach a consensus about the
condition afflicting him. Possibilities included either vasculitis in his central
1 Because this Decision contains a reasoned explanation for the action taken in this case,
it must be made publicly accessible and will be posted on the United States Court of Federal
Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal
Management and Promotion of Electronic Government Services). This means the Decision will
be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the
parties have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. Any changes will appear in the
document posted on the website.

Case 1:17-vv-00637-RMM Document 195 Filed 01/31/25 Page 2 of 48
nervous system or an encephalitis potentially due to an infection with a strain of
the coronavirus. Unfortunately, the illness has impaired B.M.’s development.
In this litigation, Ms. Dotson has retained three experts to support her claim.
They are M. Eric Gershwin, a rheumatologist with additional training in
immunology; David Wilson, a radiologist; and Yuval Shafrir, a pediatric
neurologist. Together, they opined that B.M. suffered from vasculitis and the
varicella vaccine caused the vasculitis.
The Secretary opposes an award of compensation. He has retained two
experts, Michael Kruer (a pediatric neurologist) and William Zucconi (a
radiologist). Collectively, they opine that viral encephalitis, not vasculitis, is the
appropriate diagnosis for B.M. They also maintain that the varicella vaccine did
not harm B.M. After the experts disclosed their opinions, the parties advocated
through two rounds of briefing.
A review of this material leads to the conclusion that Ms. Dotson is not
entitled to compensation. The complicated question of whether B.M. suffered
from vasculitis as opposed to encephalitis need not be resolved. Even if Ms.
Dotson had established with preponderant evidence that B.M. suffered from
vasculitis as her experts assert, Ms. Dotson has not met her burden of establishing
that the varicella vaccine caused B.M.’s vasculitis.
I. Facts
A. Early Medical History
B.M. was born in August 2013. Exhibit 6 at 16. He periodically saw his
pediatrician during his first five years of life. Exhibit 2 at 36-55.
B.M. had a well-child visit on November 7, 2014. Exhibit 2 at 31. His
development was normal. Id. at 31-35. B.M. received a dose of the allegedly
causal ProQuad vaccine.2
Twenty-four days later, B.M. returned to his pediatrician due to a fever,
which had started the day before. Exhibit 2 at 27 (Dec 2, 2014). His mother
2 The ProQuad vaccine contains attenuated, but live, measles, mumps, rubella, and
varicella viruses. Riley v. Sec’y of Health & Hum. Servs., No. 15-104V, 2021 WL 4592821, at
*12 (Fed. Cl. Spec. Mstr. Aug. 31, 2018). B.M. also received doses of the hepatitis A, influenza,
and pneumococcal vaccines. However, his claim rests upon the varicella component of the
ProQuad vaccine. Am. Pet., filed Nov. 7, 2014.
2

Case 1:17-vv-00637-RMM Document 195 Filed 01/31/25 Page 3 of 48
reported that the previous night, his temperature had reached 103.2°. On
examination, his temperature was 101.6°. Id. The examination also revealed that
B.M. was lethargic and not responsive. An examination of his ears revealed
erythematosus in his left eardrum. The pediatrician diagnosed him as suffering
from fever, seizures, and otitis media. Id. at 27-29. Dr. Kruer opined that B.M.’s
initial presentation of a fever and otitis media was consistent with B.M. having a
viral infection. Exhibit C at 2. Because the pediatrician was concerned about
seizures, B.M. was sent to the emergency room at Norton’s Children’s Hospital in
Louisville, Kentucky.
B. Norton’s Children’s Hospital3
B.M. stayed for approximately two weeks. During this time, as the doctors
ran various tests and prescribed treatments, their assessments of what was affecting
B.M. changed. While an overview of his treatment can be found in the discharge
report (Exhibit 3 at 6-35), the most relevant records are summarized on a roughly
day-to-day basis.
1. December 2, 2014
B.M. was actively seizing when he arrived at the emergency department.
Exhibit 3 at 313-16. For the seizures, doctors gave him Ativan (lorazepam),
Keppra (levetiracetam), and fosphenytoin. Id. at 6, 314-16.
B.M.’s mother also reported that he had a one-day history of fever,
decreased activity, and decreased responsiveness. The doctors prescribed
Rocephin (ceftriaxone, an antibiotic), acyclovir (an antiviral), and IV fluids. Id. at
6, 54, 316.
CT of brain
B.M. was sent for a CT scan of his brain. The interpreting radiologist,
Marilee Benson, reported “No acute intracranial process is seen.” Exhibit 3 at 194.
However, the radiologists in this litigation said it was abnormal. Exhibit 54 (Dr.
Wilson’s report) at 2; Exhibit V (Dr. Zucconi) at 3-4.
From the emergency department, B.M. was transferred to the pediatric
intensive care unit (PICU). He was unresponsive, hypertonic, and hyperreflexic.
3 According to Dr. Kruer, Norton Children’s Hospital is a tertiary care level facility.
Exhibit C at 4; see also Resp’t’s Br. at 33 n.6.
3

Case 1:17-vv-00637-RMM Document 195 Filed 01/31/25 Page 4 of 48
Exhibit 3 at 6, 11, 53, 64. He had a fever (38.3 degrees Celsius). In the PICU,
B.M. underwent a spinal tap, which is also known as a lumbar puncture. Exhibit 3
at 40-41.
Results of Spinal Tap
During the lumbar puncture, B.M. did not have elevated pressure. The
spinal tap revealed 1 white blood cell, 5 red blood cells, 64 glucose and 118
protein. Exhibit 3 at 38; Exhibit C at 1. When the cerebrospinal fluid (“CSF”)
contains elevated amounts of proteins but few cells, the condition is called
albuminocytological dissociation. Dorland’s Illus. Med. Dict. 45 (33rd ed.); see
also Resp’t’s Br. at 34.
The experts drew significantly different inferences from the CSF results. To
Dr. Shafrir, the presence of a single white blood cell meant that B.M. did not have
a viral infection. Exhibit 84 at 47. On the other hand, Dr. Kruer opined that the
elevated protein level can be found in different conditions, including encephalitis.
Exhibit BB at 3. Dr. Kruer also maintained that the lack of CSF pleocytosis and
the lack of an elevated pressure made CNS vasculitis less likely. Exhibit BB at 4.
In addition to the spinal tap, the doctors ordered other laboratory tests.
These included a respiratory pathogen panel (sometimes abbreviated “RPP”) and
standard blood work.
Respiratory Pathogen Panel / Coronavirus
The respiratory pathogen panel revealed that B.M. was infected with a strain
of the coronavirus, OC-43. Exhibit 3 at 68; see also Exhibit 3 at 13 (discharge
report). This strain of the coronavirus differs from the strain that caused the
pandemic, starting in 2020. Exhibit P at 2. The detection of the coronavirus is a
foundation for the Secretary’s position that an infection caused B.M.’s
encephalitis. See Resp’t’s Br. at 31.
Ms. Dotson’s set of experts responded to the detection of encephalitis
differently. To start, Dr. Gershwin asserts that the test was a false positive.
Exhibit 18 at 4 (“the team at Norton’s Children’s Hospital was misled by the
PCR”). However, Dr. Gershwin provides neither a reliable nor persuasive reason
to negate the test results. More credibly, Ms. Dotson’s other experts question
whether the coronavirus can cause encephalitis.
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Case 1:17-vv-00637-RMM Document 195 Filed 01/31/25 Page 5 of 48
Routine Blood Work
In the set of labs, a test for liver enzymes showed AST was high at 1273 and
ALT was also high at 1271. Exhibit 3 at 37.
Again, Dr. Shafrir and Dr. Kruer disputed the meaning of elevated liver
enzymes. Dr. Shafrir proposed that B.M.’s liver function was impaired possibly
because of vasculitis. Exhibit 84 at 44. Dr. Kruer stated elevations in liver
enzymes can occur for many reasons, including a coronavirus infection. Exhibit
BB at 6. Dr. Kruer claimed: “Arguing that elevated liver enzymes indicate
vasculitis is akin to arguing that a headache can only be explained by a brain
tumor.” Id.
2. December 3, 2014
Dr. Ruppe wrote that B.M.’s condition was “very concerning for
meningoencephalitis or other CNS injury.” Exhibit 3 at 53. The doctor also stated
that B.M.’s “LP does not suggest infection, but would treat broadly. Coronavirus
on RPP could be first evidence of viral syndrome.” The doctor anticipated that an
MRI, which was planned for later in the morning, could add information. Exhibit
3 at 53. B.M. was intubated in anticipation of the MRI. Exhibit 3 at 53.
December 3, 2014 Brain MRI
The interpreting radiologist, Karen Moeller, identified “multiple areas of
signal abnormality.” Exhibit 3 at 196. Based upon this information, Dr. Moeller
considered “embolic infarctions or fat emboli syndrome.” Id.
In this litigation, some experts reviewed the imaging from the December 3,
2014 brain MRI. Doctor Wilson basically concurred with Dr. Moeller’s
interpretation. Exhibit 54 at 3. Dr. Zucconi also agreed. Exhibit V at 4.
CT Angiogram
A CT angiogram was conducted on B.M.’s head and neck on December 3,
2014. Exhibit 3 at 199. A CT angiogram “is a minimally invasive form of
angiography in which contrast material is injected intravenously through a small
needle . . . and precise, detailed images of the vascular system are produced by
computed tomography.” Dorland’s at 83. One purpose is to detect “abnormalities
of cerebral circulation.” Kathleen D. Pagana & Timothy J. Pagana, Mosby’s
Manual of Diagnostic and Laboratory Tests 930 (6th ed. 2018). For B.M., no
vascular malformation was detected. Exhibit 3 at 189-90, 199.
5

Case 1:17-vv-00637-RMM Document 195 Filed 01/31/25 Page 6 of 48
The experts disputed the significance of the CT angiogram. Dr. Wilson
stated that it was potentially abnormal. Exhibit 54 at 3-5. Dr. Wilson stated: “In
the literature, 30% of patients with Varicella-Zoster virus (VZV) vasculitis have a
normal angiogram because of predominant small-vessel involvement.” Exhibit 54
at 5, citing Exhibit 57 at 107.4 Dr. Shafrir asserted that people with vasculitis in
their central nervous system can be negative on an angiogram. Exhibit 84 at 45,
48. On the other hand, Dr. Kruer maintained that the normal CT angiogram made
a diagnosis of vasculitis less likely. Exhibit C at 3.
On December 3, 2014, a neurologist, Darren Farber (attending), reviewed
the results from the December 3, 2014 brain MRI. Dr. Farber discussed with “the
ICU [intensive care unit] team that the likely etiology for [B.M.’s] presentation
was a CNS vasculitis. MRI findings are not suggestive of a demyelinating process,
and a primary infectious process (encephalitis/meningitis) is not likely given NL
[normal] CSF WBC.” Exhibit 3 at 71. The neurologist did not close the door to
other conditions as he added: “vasculitis may be assoc w/ certain viruses, etc.” Id.
“Will also [discuss with] [neurosurgery] need for formal angiogram.” Id.
Echocardiogram
On December 3, 2014, an echocardiogram was performed. Exhibit 3 at 176.
Dr. Lee noted that the echocardiogram showed: “Normal cardiac anatomy,
chamber sizes, and systolic function. No evidence of RV hypertension. No
pericardial effusion. No evidence of gross vegetations or thrombi. TTE does not
rule out small vegetations or thrombi.” Id.
MR Angiogram
Dr. Farber consulted Dr. Dashti and they agreed to proceed with an
“emergent MRI Angiography today.” Exhibit 3 at 368. The purpose was to rule
out vasculitis. Id. at 189. There was “No angiographic evidence of vasculitis.” Id.
at 190; accord Exhibit 3 at 330.
In the litigation, Dr. Wilson reviewed the MR Angiogram and concurred this
study was normal. Exhibit 54 at 3. Dr. Wilson attempted to reconcile the results
of this angiogram with the previous angiogram, which Dr. Wilson described as
potentially abnormal. Dr. Wilson hypothesized that either the earlier CT
angiogram had technical limitations that suggested an irregularity that did not
4 Maria A. Nagel & Andrew N. Bubak, Varicella Zoster Virus Vasculopathy, 218 J. OF
INFECTIOUS DISEASES 107 (2018); filed as Exhibit 34.
6

Case 1:17-vv-00637-RMM Document 195 Filed 01/31/25 Page 7 of 48
actually exist or B.M. improved between studies. Id. at 3-4. Dr. Zucconi said the
MR Angiogram was normal. Exhibit V at 6.
After the MRI and MR angiogram were completed, specialists in pediatric
infectious diseases, Dr. Rabalais (attending) and Dr. Rebecca Hart (resident), saw
B.M. They wrote that the MRI and MR angiogram made an infectious etiology
“less likely.” Exhibit 3 at 97. They noted the presence of coronavirus on the
respiratory pathogen panel and stated. “Unclear significance in relation to the brain
lesions.” Id. at 99. The infectious disease specialists changed the antibiotics to
vancomycin, meropenem, and Bactrim. Id. at 98-99. The infectious disease
specialists also discontinued acyclovir. Id. at 98.
3. December 4, 2014
A rheumatologist, Kenneth Schikler, saw B.M. Dr. Schikler was concerned
about “Small Vessel CNC [sic] vasculitis which can be secondary to infectious,
non-infectious inflammatory autoimmune or autoinflammatory diseases as well as
metabolic/mitochondrial disorders.” Exhibit 3 at 149. This doctor recommended a
series of tests, including a test for von Willebrand re: antigen, in the context of
potentially starting cyclophosphamide. Id.
Cyclophosphamide is a medication to treat various types of cancer.
Dorland’s at 451. It can also be used as an “immunosuppressive agent . . . in the
treatment of certain diseases with abnormal immune function.” Id. A trademarked
preparation of cyclophosphamide is called “Cytoxan.” Dorland’s at 462.
On December 4, 2014, a test for von Willebrand related antigen was ordered
by Dr. Morgan and performed. Exhibit 3 at 171 and 260. Von Willebrand factor is
a “glycoprotein synthesized in endothelial cells… that circulates complex to factor
VIII; it mediates adhesion of platelets to damaged epithelial surfaces.” Dorland’s
at 670.
Von Willebrand factor (vWF) antigen is a plasma protein
that is synthesized by megakaryocytes and endothelial
cells and is released when vascular endothelium is
damaged or inflamed. As a result, this vessel-derived
factor may be more responsive to changes in vasculitic
disease activity and less influenced by systemic stimuli
than other inflammatory markers.
7

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Exhibit 98 (Cellucci) at 734-35.5
For B.M., the results for Factor VIII related Ag were elevated at greater than
150. Exhibit 3 at 171. Dr. Schikler noted that based on the “elevated factor VIII re
Ag which is indicative of vasculitis, in spite of the ‘nl’ arteriogram (which is not
unusual in Small Vessel CNS Vasculitis svCNS V) and lack of brain tissue from a
biopsy, and [B.M.’s] condition I have discussed this with Dr. Farber and agree that
aggressive Rx for [svCNS] vasculitis is appropriate.” Id. at 150.
An important consultation with the pediatric infectious disease specialists
occurred on December 4, 2014. Dr. Woods (attending) was attempting to
determine the etiology for B.M.’s altered mental status. The “MRI/MRA with
multiple lesions throughout cerebrum, cerebellum [and] brainstem [were]
concerning for embolic infarct vs. vasculitis, less likely infectious etiology.”
Exhibit 3 at 343. Dr. Woods noted that B.M. is “Coronavirus positive—there are
brief accounts in the literature of presenting with seizure activity or
encephalopathy, but case reports are minimal and would not be expected to present
with MRI finding seen.” Id. The doctor offered another idea:
“Postinfectious/post-viral encephalopathy is also a possibility. [B.M.] has received
a varicella vaccine (his first dose) in the last month prior to presentation, and there
are some minimal case reports of varicella encephalitis and vasculitis, although
none are reported after vaccination in children.” Id.
The treatment recommendations illustrate how the doctors were struggling to
treat B.M., as they weighed the advantages and disadvantages of different
approaches. Id. at 343-44. The impression was that B.M.’s process “is unlikely
infectious in nature though it could be a post-infectious inflammatory syndrome.
VZV-related vasculitis is not impossible, but unlikely.” Id. at 345.
Commentary on the December 4, 2014 Report from the Infectious Disease
Specialist
Although Dr. Woods had indicated that the results of the MRI suggested an
infectious etiology was “less likely,” Dr. Zucconi disagreed. Exhibit V at 9;
Exhibit Y at 2.
5 Tania Cellucci & Susanne M. Benseler, Diagnosing central nervous system vasculitis in
children, 22 CURRENT OPINIONS IN PEDIATRICS 731 (2010); filed as Exhibit 98.
8

Case 1:17-vv-00637-RMM Document 195 Filed 01/31/25 Page 9 of 48
As part of his recommendations, the infectious disease expert ordered testing
for varicella zoster virus. Exhibit 3 at 344.
Results of Varicella Zoster Virus Testing
Type of Test Result Date Result Page within Exhibit 3
Returned
CSF PCR Unable to 12/7/2014 472, 497
Perform
Bone marrow Negative 12/9/2014 1516
PCR
CSF antibody Negative 12/12/2014 1535-36
12/18/2014 1548
Serum PCR Negative 12/16/2014 303, 592
A pediatric neurologist conferred with B.M.’s parents. Dr. Farber informed
them that B.M.’s “MRI is suggestive of a small vessel vasculitis, and often times
the angio may be [normal] in this situation.” Exhibit 3 at 369. Based upon this
information, B.M.’s parents asked whether B.M. could be transferred to Toronto’s
Children’s Hospital, whose staff has “the most experience w/ CNS vasculitis in
children, and we discussed that [B.M.] is not stable enough for transfer. [But,]
Toronto’s protocol is well published, and that we will start Cytoxan.” Id.
Part of the neurologist’s consultation concerned whether to biopsy B.M.’s
brain. “A biopsy is the most definitive test to [diagnose] a small vessel CNS
vasculitis, and is [recommended if] the formal angio is [normal] but it is an
invasive procedure, and will not change our current management.” Id. B.M.’s
parents and his medical team “decided to hold off on this for now.” Id.
In the meantime, the neurologist wanted to obtain another MRI of B.M.’s
brain tomorrow “to assess for new areas of ischemia, cerebral edema or
[hemorrhage].” Id. The neurologist also wanted to “maximize his
immunosuppression [treatment] and will start IVIG.” Id.
The general progress notes agree with the pediatric neurology notes from
December 4, 2014 that the working diagnosis is a small vessel vasculitis. Exhibit 3
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at 368. Dr. Farber noted that B.M.’s “neuro exam unchanged, however has
developed autonomic instability, suggestive of a disease progression.” Id. at 369.
Dr. Farber discussed the need for a brain biopsy with B.M.’s parents because a
biopsy “is the most definitive test to [diagnose] a small vessel CNS vasculitis, and
is [recommended if] the formal angio is [normal].” Id. Dr. Farber also discussed
the need for anticoagulation because B.M. did not appear to have a primary
thrombo-embolic disease, and Dr. Farber was “concerned for the potential of
bleeding given his high ischemia burden.” Id.
4. December 5, 2014
The pediatric rheumatologist, Dr. Schikler, considered the appropriate
treatment course for B.M. in light of uncertainties:
Based on the elevated factor VIII re Ag which is
indicative of vasculitis, in spite of the “nl” arteriogram
(which is not unusual in Small Vessel CNS Vasculitis
svCNSV) and lack of brain tissue from a biopsy, and
[B.M.’s] condition I have discussed this with Dr. Farber
and agreed this aggressive Rx for svCNS vasculitis is
appropriate.
Exhibit 3 at 150.
Dr. Schikler “discussed with [B.M.’s] mom and dad the drug itself and its
side effects and risks and they understand why it is being recommended and agreed
to its use.” Id. Accordingly, the doctor ordered Cytoxan and prednisone. Id.
Second Brain MRI on December 5, 2014
As the neurologist had ordered on December 4, 2014, B.M. had another MRI
on December 5, 2014. Exhibit 3 at 206. The MRI revealed: “Multiple lesions are
again visualized scattered throughout both cerebral hemispheres.… There are also
lesions in the basal ganglia brainstem and cerebellum. The corpus callosum is also
involved.” Id. The impressions of the radiologist (Dr. Moeller) included: “The
differential diagnosis includes an atypical ADEM or perhaps a small vessel
vasculitis.” Id. at 207.
The pediatric neurology follow up on December 5, 2014 stated that: “Brain
MRI was essentially stable, no significant new areas of cytotoxic edema.” Exhibit
3 at 408. “Today had lengthy [discussion with] family along [with] peds heme-
onc, we discussed that his ANC was dropping for reasons that were not entirely
10

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clear, but likely related to his underlying autoimmune/rheumatolic disorder, and
therefore would obtain a bone marrow biopsy/aspirate.” Id. Additionally, “also
[discussed with] parents that on his abd US, liver showed ? Areas of inflammation
(LFTs have been improving), ? Liver biopsy as well at some point in his workup
. . . given his low PLT, and small area of hge on MRI, would not place him on any
anti-LPT TX or anti-coagulation.”6 Id. “[Neuro] exam stable today, no significant
changes.” Id.
The experts drew different conclusions from the second MRI. Dr. Wilson
stated that abnormalities on the December 5, 2014 brain MRI included T2 or
“gradient” images that are sensitive to hemorrhage. Exhibit 54 at 4; Pet’r’s Br. at
21. Dr. Shafrir compared the results of the two MRIs. In his opinion, the lack of
progression was inconsistent with a viral etiology. Exhibit 84 at 48; Pet’r’s Br. at
29. In contrast, Dr. Zucconi opined that the prominent areas of T2 signal
hyperintensity without a corresponding diffusion abnormality were most
compatible with a viral encephalitis. Exhibit V at 8-9; see also Resp’t’s Br. at 32.
The infectious disease specialist, Dr. Rabalais, saw B.M. on December 5,
2014. His impressions included:
1. Stable neurologically with as yet unexplained multiple acute lesions in
brain thought to be a vasculitic process
2. Coronavirus infection
3. [Status/post] varicella immunization: PCR pending
4. Continued fall in WBC, [platelets] and [hemoglobin] are of concern
Exhibit 3 at 397. His recommendations show that B.M.’s medical team was
balancing several factors.
1. Acyclovir dosing as in Dr. Hart’s note above; if renal toxicity along with
other medications is of concern, would stick with low dose. Consider
stopping [acyclovir] if blood PCR is negative. I think there is a very very
low likelihood that this CNS process represents a varicella vaccine
complication, but until we have a definitive answer, it seems reasonable to
continue for now.
2. Continue [vancomycin] and Meropenem for now. All cultures are negative
and there has been no progression of the lesions to suggest multiple septic
6 It is not readily apparent in the record whether ‘hge’ is an abbreviation for hemorrhage
or not.
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emboli with evolution to small brain abscesses so again, the likelihood of
this being a bacterial infection is very low.
3. Consider bone marrow exam given fall in hematologic parameters to rule out
leukemia as precipitating event for these lesions.
Id. at 397. A bone marrow biopsy showed no evidence of leukemia. Exhibit 3 at
175, 240-42 (Dec. 6, 2014); Pet’r’s Br. at 13.
As the doctors had planned with B.M.’s parents, Cytoxan was started.
Exhibit 3 at 429; Pet’r’s Br. at 13. Dr. Shafrir interpreted the prescription of
Cytoxan as indicating that the “treating physician did not think that it is acute viral
encephalitis. The[y] actually took a bold move and started to treat the patient
immediately with high do[s]es methylprednisolone and cyclophosphamide.”
Exhibit 84 at 46; Pet’r’s Br. at 31. Dr. Shafrir reasoned: “if he had acute viral
encephalitis, one would expect this treatment to make the patient worse. They
would not have done that if they would have any worry about acute viral
encephalitis.” Id. On the other hand, the Secretary argues: “Dr. Shafrir has
provided no evidence for the notion that B.M. would not have been given Cytoxan
by his physicians if he had had encephalitis.” Resp’t’s Br. at 34.
5. December 6, 2014
The neurologist, Dr. Farber, saw B.M. and assessed him as “slightly
improved” on examination. Exhibit 3 at 444. Dr. Farber’s note again shows the
complexity of the case: “Current working diagnosis is a small vessel vasculitis.
Patient is currently being treated with steroids, IVIG and Cytoxan to cover for
vasculitides and demyelinating disorders as his presentation and workup is not
classic for either.” Id.
6. December 7, 2014
An infectious disease specialist saw B.M. The assessment begins by stating
that there are “multiple possible etiologies” for B.M.’s “altered mental status.”
Exhibit 3 at 471-72. Dr. Hart recounted that the “Current thinking given [patient’s]
Factor VIII related antigen levels is that this may represent a small vessel CNS
vasculitis vs. Demyelinating process. [Patient] has no evidence of vasculitis on
cerebral angiogram but per Dr. Schikler this is not unexpected.” Id.
The note from the infectious disease specialist from December 7, 2014 also
memorializes that B.M. was receiving various medications: B.M. is now status post
“IVIG x 1 on 12/4, 3 doses of pulse IV Solu-Medrol, and Cytoxan on 12/5.” Id. at
472.
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This December 7, 2014 note echoed the earlier December 3, 2014 note in
that both discussed that B.M. was coronavirus positive and that he had received a
varicella vaccine in the month before presentation. The December 7, 2014 note
added that B.M.’s “VZV PCR in the serum is negative (unable to obtain on CSF).
Id. at 472.
7. December 8-10, 2014
B.M. was more responsive and was extubated. Exhibit 3 at 151-52; Pet’r’s
Br. at 13; Resp’t’s Br. at 5.
Flow Cytometry
An immunologist was consulted because B.M. was having persistent
leukopenia. (“Leukopenia” means the person has a reduction in the number of
white blood cells. Dorland’s at 1015 (defining “leukocyte”), 1017 (defining
“leukopenia” in reference to leukocytes.) The immunologist ordered flow
cytometry. “Flow cytometry” measures and characterizes cells and cellular
constituents. Dorland’s at 461. In Dr. Gershwin’s view, flow cytometry is
complex and fraught with error. Exhibit 47 at 4; Pet’r’s Br. at 25.
B.M.’s flow cytometry was abnormal. He lacked T-memory cells. Exhibit 3
at 12-13, 229-30, 1509-10. In the opinion of Dr. Kruer, B.M.’s immunodeficiency
would predispose him to a neural invasion from a coronavirus. Exhibit C at 4;
Exhibit P at 2-3; Exhibit X at 3-4.
A new pediatric neurologist, Vinay Puri, began treating B.M. on December
8. He stated that B.M. was “stuporous” and had “left sided weakness.” Exhibit 3
at 525. Dr. Puri assessed B.M. as having “ADEM with a small vessel vasculitic
component.” Id. at 524. He added that: “This could be related to Corona virus.”
Id. at 525.
A new pediatric rheumatologist started to see B.M. on December 9, 2014.
Dr. Kara Murphy Schmidt repeated what the neurologist had said the day before –
the “working diagnosis is ADEM with small vessel vasculitic component.”
Exhibit 3 at 559. Dr. Murphy Schmidt also requested a repeat Von Willebrand
factor antigen test to assess for improvement in vasculitis. Exhibit 3 at 559.
B.M.’s history in the pediatric intensive care unit was summarized when he
was moved from the PICU to the pediatric floor. See Exhibit 3 at 565-70. At the
time of transfer, the current differential diagnosis was “ADEM vs small vessel
vasculitis.” Id. at 566
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8. December 11-15, 2014
Another flow cytometry was ordered on December 11, 2014. The results
were again abnormal. Exhibit 3 at 229-30. An immunologist, Gerald Lee, who
saw B.M. on December 15, 2014 suggested that B.M.’s immunodeficiency was
likely secondary due to immunosuppression therapy. Id. at 176.
On December 12, 2014, Gregory Barnes became the attending neurologist.
An advanced practice nurse on Dr. Barnes’s team stated that the “MRI findings
[were] concerning for ADEM alongside a small cell vasculitic process post viral
illness.” Exhibit 3 at 586. For diagnosis, Dr. Barnes wrote that: “The child likely
has ADEM.” Id.
A pediatric infectious disease doctor also stated that: “Diagnosis felt to be
consistent w/ small vessel CNS vasculitis vs. ADEM.” Exhibit 3 at 591 (Dec 12,
2014). Dr. Hart ruminated on potential causes:
Infectious etiologies are considered unlikely as [patient]
has had normal blood and CSF [cultures] (as well as
normal CX from B.M.A), normal echo and CTA. Post-
infectious or post-vaccine response is a possible cause for
ADEM and vasculitis, and Coronavirus (for which
[patient’s] RPP was positive) has been reported to cause
ADEM with current infection in some case reports.
While [patient] did receive several vaccinations
(including varivax, MMR, flu) in the month prior to
presentation, there is less evidence for vaccinations as a
cause of ADEM.
Id.
The attending doctor (Dr. Woods) noted that test for various infectious
organisms were negative. “No evidence of [herpes simplex virus] or VZV
infection, thus acyclovir can be discontinued.” Exhibit 3 at 592.
Dr. Woods concluded: “Best estimate of diagnosis is small vessel vasculitis
+/- ADEM as a postinfectious manifestation of coronavirus infection. Recent
vaccines are unlikely to be the triggering event based on epidemiologic studies.”
Id.
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Discharge on December 15, 2014
B.M. was discharged from Norton Children’s Hospital to a rehabilitation
hospital on December 15, 2014. Exhibit 3 at 6, 14. Dr. Puri, who authored the
report, reviewed the lesions in B.M.’s brain and stated that the “process is likely
viral [in] its etiology.” Id. at 15. The discharge report stated that B.M. “was
treated aggressively upon admission with IV Solu-Medrol, IVIG and Cytoxan.
The patient is now manifesting a neutropenia secondary to Cytoxan.” Id. Dr. Puri
also stated: “no evidence for a CNS vasculitis based on formal angiography.” Id.
C. Rehabilitation, Rehospitalization, and Second Rehabilitation7
B.M. stayed at an inpatient rehabilitation facility, Frazier Rehab Institute, for
five days. Exhibit 5 at 14-15 (December 15-19, 2014).
Due to a high fever, B.M. was readmitted to the hospital from December 19
through December 23, 2014. During this stay, he tested negative for the
coronavirus. Exhibit 3 at 1576 (Dec 19, 2014). He was described as
developmentally delayed. Exhibit 3 at 1559-60, 1562.
For the next month, B.M. had a second inpatient rehabilitation. For this
month, B.M. received daily physical, occupational, and speech therapy. When he
was discharged, B.M. was sitting independently and standing with hands-on
assistance. Exhibit 5 at 10-11.
D. Remainder of 2015
B.M. followed up with the pediatric rheumatologist, Kara Schmidt. Her
assessment was “ADEM with small vessel vasculitic component.” Exhibit 14 at 2
(Jan. 26, 2015). Around this time, B.M. was receiving speech therapy, physical
therapy, and occupational therapy three times per week. Exhibit 4 at 9-17.
At a stroke clinic in February 2015, B.M. saw his neurologist, Dr. Puri. He
had left-sided weakness and increased tone. He could not walk independently.
While on Keppra, he had not had any seizures since his hospitalization.
7 The medical records created after B.M. was discharged from Norton Children’s
Hospital are relatively less valuable in determining whether the varicella vaccine harmed him.
Thus, these records are described more summarily. For additional details, see Pet’r’s Br. at 18-
19; Resp’t’s Br. at 8-11.
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Assessments included vasculopathy and cerebral palsy. Dr. Puri recommended
repeating the immunologic testing, EEG, and MRI. Exhibit 8 at 19-22.
The repeated immunologic testing included another flow cytometry. The
results showed decreased absolute numbers of T cells and B cells, suggesting a
primary or secondary immunodeficiency. Exhibit 3 at 1823-24, 1849-51.
The repeated neurologic testing occurred in April 2015. The EEG was
within normal limits. Exhibit 8 at 23-24. The brain MRI showed “near-complete
interval resolution of multiple lesions throughout both cerebral hemispheres and
cerebellum compared to December 2014 suggestive of a resolved ADEM or
perhaps an unusual resolved viral encephalitis.” Exhibit 8 at 31.
This MRI was reviewed by Dr. Puri in the stroke clinic. B.M.’s parents
stated that he was making significant gains in development, including pulling
himself up and crawling. However, he could not walk independently. Exhibit 8 at
14 (May 7, 2015). Dr. Puri wrote that the “neuroimaging of the brain
demonstrated multiple small areas of infarction believed to be secondary to a viral
encephalitis/vasculitis caused by Coronavirus.” Id. The parents mentioned that
B.M. was scheduled to see immunology again. The assessment was largely the
same as in February 2015 --- such as cerebral palsy. Dr. Puri stated that the
cerebral palsy was milder than expected based upon B.M.’s initial presentation. Id.
at 17-18.
Another flow cytometry happened the next month. Although the results
were similar to the February 17, 2015 flow cytometry, the “percentage and total
number of CD4+ T-cells has increased resulting in an normal CD4:CD8 ratio and
total T-memory cells are within expected range.” Exhibit 12 at 9.
Dr. Lee saw B.M. about three months later. Dr. Lee wrote that he
“consulted on [B.M.] while hospitalized for encephalomyelitis following
coronavirus infection. He was treated with Cytoxan and corticosteroids and
developed lymphopenia, which at the time I felt was more secondary to his
treatment rather than an immune deficiency.” Exhibit 12 at 2 (May 18, 2015).
Based, in part, on the results from a flow cytometry, Dr. Lee stated that B.M.’s
lymphopenia was “improving.” Id. at 6. Dr. Lee reiterated he suspected that the
lymphopenia was “secondary to immune suppression rather than primary immune
deficiency.” Id.
In December 2015, B.M. returned to the stroke clinic. He was no longer
taking Keppra and had not had any seizures. Exhibit 8 at 8, 18. Dr. Puri, the
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neurologist, observed that B.M. had speech, language, and motor delays, and was
likely to have long-term motor deficits. The history included an “acute central
nervous system vasculopathy which I believe was viral in etiology.” Id. at 12.
E. 2016 and More Recent
“B.M. continued to be followed by multiple specialists and engaged in
rehab.” Pet’r’s Br. at 19. The parties did not further summarize medical records.
See Pet’r’s Br. at 19; Resp’t’s Br. at 10-11.
Ms. Dotson averred that B.M. did not see an immunologist after 2015.
Exhibit 115 (affidavit, signed Apr. 15, 2024) ¶ 5. She also stated that B.M. has not
tested positive for the pandemic’s coronavirus. SARS-CoV-2. Id. at ¶ 7.
II. Procedural History
A. Development before Expert Reports
Represented by attorneys from Maglio Christopher and Toale, Ms. Dotson
alleged various vaccines caused B.M. to suffer ADEM. Pet., filed May 15, 2017.
Ms. Dotson supported her claim by filing medical records and affidavits.
The Secretary reviewed this material and recommended against
compensation. Resp’t’s Rep., filed Nov. 9, 2017. The Secretary challenged Ms.
Dotson’s claim that B.M. suffered from ADEM and argued that, even if B.M. did
suffer from ADEM, the evidence in the record did not support a finding that the
ADEM was caused-in-fact by the vaccines B.M. received. Part of the deficiency,
according to the Secretary, was that Ms. Dotson did not present expert opinion
linking the vaccination to the alleged condition. Id. at 10-11.
Because it seemed likely that Ms. Dotson would attempt to present an
opinion from an expert, a set of instructions for experts were proposed. Order,
issued Nov. 27, 2017. After neither party interposed any objection, the instructions
became final. Order, issued Dec. 12, 2017.
Ms. Dotson did not speedily present a report from an expert. See First Order
to Show Cause, issued Apr. 29, 2019 (recounting reasons for not filing an expert
report). During this time, an attorney from Maglio Christopher & Toale was
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replaced as counsel of record. Attorney Richard Gage became counsel of record
on August 14, 2018, and has represented Ms. Dotson since then.8
Slightly more than two months after Mr. Gage’s appearance, the Secretary
sought dismissal due to the lack of an expert report. Resp’t’s Mot. to Dismiss,
filed Nov. 27, 2018. Mr. Gage stated that he had become counsel of record on
August 14, 2018, and that he anticipated that he would file a report from Lawrence
Steinman after the first of the year. Pet’r’s Status Rep., filed Nov. 28, 2018.
Based upon this representation, the Secretary’s motion to dismiss was denied.
Order, issued Dec. 6, 2018. This order set a deadline of January 7, 2019 for Ms.
Dotson to provide more information about a report from Dr. Steinman.
B. Dr. Gershwin’s Initial Reports
Consistent with the representation in the November 28, 2018 status report,
Ms. Dotson proposed filing a report from Dr. Steinman in 60 days. Pet’r’s Status
Rep., filed Jan. 7, 2019. Ms. Dotson was afforded the time she had requested.
Order, issued Jan. 8, 2019 (setting deadline of March 8, 2019). On the deadline,
Ms. Dotson requested additional time. Pet’r’s Mot., filed Mar. 8, 2019. Ms.
Dotson was again granted the amount of time she had requested. Order, issued
Mar. 13, 2019.
Ms. Dotson did not file a report from Dr. Steinman. Instead, Ms. Dotson
submitted a letter from M. Eric Gershwin. Exhibit 15. This statement from Dr.
Gershwin asked for more information and in the statement, Dr. Gershwin did not
opine that any vaccination harmed B.M. Due to the multiple unsuccessful efforts
to support the case with an expert report, Ms. Dotson was faced with a dismissal of
her case. First Order to Show Cause, issued Apr. 29, 2019.
Ms. Dotson supported her claim by filing a six-page report from Dr.
Gershwin, dated May 14, 2019. Exhibit 18.9 (This decision treats the May 14,
2019 report as Dr. Gershwin’s first report.) Dr. Gershwin opined that a varicella
vaccine caused B.M. to suffer vasculitis in his central nervous system. Id. at 6. In
discussing the events in B.M.’s medical history, Dr. Gershwin was “concerned
8 Before Mr. Gage became counsel of record, a motion for an award of attorneys’ fees
and costs on an interim basis was filed. This motion was denied. Interim Fees Decision, issued
Feb. 28, 2019.
9 Throughout the litigation, the parties filed medical articles on which their experts relied.
The dates of those various submissions are not detailed in this Decision. Ms. Dotson filed two
exhibits as exhibit 18. Dr. Gershwin’s expert report is ECF No. 55.
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about two potential factual errors in the medical records that will lead to incorrect
interpretation of the data and therefore an incorrect diagnosis in this youngster.”
Id. at 4. The first potential error was that in Dr. Gershwin’s opinion, B.M. did not
have an immune deficiency. Id. The second potential error was that in Dr.
Gershwin’s opinion, B.M. did not suffer from an infection with a coronavirus. Id.
at 4-5.
While describing vasculitis, Dr. Gershwin cited an article by Twilt and
Bender. Id. at 5 (reference 16). The Twilt and Benseler article is about CNS
vasculitis in children. Exhibit 36.10 Dr. Gershwin wrote that the “mechanism of
varicella-induced vasculopathy appears to be that of vasculitis and the authors note
that the most common etiology is infection and they emphasize varicella.” Exhibit
18 at 5.
The Secretary argued that Ms. Dotson’s case should be dismissed. Resp’t’s
Mot., filed May 29, 2019. In the Secretary’s view, Ms. Dotson “has failed to meet
the requirements for compensation for a causation-in-fact injury claim.” Id. at 3.
This lack of proof was due, in part, because “Dr. Gershwin’s reports are patently
insufficient to meet petitioner’s burden of proof.” Id.
Ms. Dotson’s response to the Secretary’s May 29, 2019 motion to dismiss
took two forms. First, Ms. Dotson argued that the Secretary’s motion to dismiss
without an evidentiary hearing was procedurally improper because the only way to
dismiss a case without a hearing was through summary judgment. Pet’r’s Resp.,
filed June 12, 2019.11 Second, Ms. Dotson added another report from Dr.
Gershwin. Exhibit 40. This June 18, 2019 report is approximately one page.
Although Dr. Gershwin asserts that this supplemental report “will focus on the
three (3) Althen prongs,” id. at 1, Dr. Gershwin wrote approximately one sentence
on Althen prong one and two sentences on Althen prong two. The balance of the
report was about Althen prong three.
Dr. Gershwin’s reports were deemed not satisfactory. Ms. Dotson, thus,
faced dismissal again. Second Order to Show Cause, issued Sep. 6, 2019. The
10 Marinka Twilt & Susanne M. Benseler, The spectrum of CNS vasculitis in children and
adults, 8 NATURE REV. RHEUMATOL. 97 (2012); filed as Exhibit 36.
11 The Federal Circuit later rejected this argument. Kreizenbeck v. Sec’y of Health &
Hum. Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2020).
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Second Order to Show Cause identified problems that continue to impair Ms.
Dotson’s case.
A problem was that Dr. Gershwin may not have disclosed a theory
explaining how the varicella vaccine can cause vasculitis. Second Order to Show
Cause, issued Sep. 6, 2019, at 3. The undersigned “stretch[ed] what Dr. Gershwin
[had] written” to understand that Dr. Gershwin may have been proposing a theory
based upon “either a varicella infection or a hypersensitivity reaction. Both are
problematic.” Id. at 3. First, although the varicella vaccine might lead to a
varicella infection as a matter of theory, Ms. Dotson could not prevail upon this
theory because Dr. Gershwin wrote: “I submit that there is no evidence of
infection.” Exhibit 18 at 4. Alternatively, Dr. Gershwin may have proposed a
hypersensitivity reaction. But, this theory seemed incapable of resulting in an
award of compensation to Ms. Dotson because (a) “Dr. Gershwin has not cited
evidence that B.M. suffered an allergic reaction” and (b) “the latency between the
vaccination . . . and the date of hospitalization . . . (25 days) appears to exceed the
amount of time expected for an allergic reaction to manifest.” Second Order to
Show Cause at 4. Thus, Ms. Dotson was given another opportunity to present “a
comprehensive, complete, and reliable report from Dr. Gershwin.” Id. Ms. Dotson
was directed to have Dr. Gershwin comply with the Instructions and to submit “a
single, stand-alone report.” Id.
Ms. Dotson attempted to comply by filing another report from Dr. Gershwin.
Exhibit 47. This October 2, 2019 report is approximately eight pages. As
permitted in the Second Order to Show Cause, Dr. Gershwin copied much of the
material from his previous reports into this report. For example, Dr. Gershwin
continued to deny that B.M. suffered from “immune deficiency” and Dr. Gershwin
continued to dispute B.M. was infected with a coronavirus. Id. at 4. Dr. Gershwin
also maintained that B.M suffered from “small vessel vasculitis.” Id.
As for the theory by which a varicella vaccine can cause small vessel
vasculitis, Dr. Gershwin’s October 2, 2019 report was not a model of clarity.
Under the heading “Theory, Althen 1,” Dr. Gershwin wrote approximately four
paragraphs. Exhibit 47 at 5-6. However, discerning a theory within this section is
difficult. For example, Dr. Gershwin wrote: “The ‘theory’ is that Varicella
antigens, whether from a live virus or from a live viral Varicella vaccine can cause
CNS vasculitis. The cause and effect relationship between the Varicella antigen
and CNS vasculitis is known and accepted by the medical community.” Id. at 6.
For the proposition, that the medical community accepts this relationship Dr.
Gershwin cited a series of case reports as well as one article, Wise. Under the
heading, “Althen III,” Dr. Gershwin wrote another paragraph and within this
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paragraph, Dr. Gershwin discussed timing in the context of molecular mimicry. Id.
at 6.
In conjunction with the submission of Dr. Gershwin’s October 2, 2019
report, Ms. Dotson amended her petition. Ms. Dotson now alleged the November
7, 2014 varicella vaccine caused B.M. to suffer “the immune-mediated injury of
cerebral vasculitis.” Am. Pet., filed Oct. 3, 2019, ¶ 5.
Dr. Gershwin’s October 2, 2019 report appeared adequate.12 Thus, a status
conference was held.
C. Development of Additional Expert Opinions
During the October 23, 2019 status conference, the parties discussed Dr.
Gershwin’s most recent report. It appeared that Dr. Gershwin was relying upon the
theory of molecular mimicry. Order, issued Oct. 23, 2019. Thus, the Secretary
was directed to respond. Id.
The Secretary responded to Dr. Gershwin’s opinions by presenting a report
from Dr. Kruer, which is approximately four pages. Exhibit C. Dr. Kruer made
three points and added one request. First, Dr. Kruer asserted B.M. likely suffered
an infection with a primary coronavirus. Id. at 2. Second, Dr. Kruer stated that a
“diagnosis of vasculitis was never confirmed.” Id. at 3. Third, Dr. Kruer opined
that B.M. suffered a primary immunodeficiency. Id. Dr. Kruer’s request was to
obtain original images of various studies. Id.
In due course, the images were obtained and provided to Dr. Kruer. Dr.
Kruer wrote a second report, which was slightly longer than three pages. Dr. Kruer
presented opinions about the images. Exhibit P at 1-3. Dr. Kruer also commented
upon the Althen prongs. In Dr. Kruer’s opinion, Dr. Gershwin “has not proffered a
theory of causality.” Id. at 3. Dr. Kruer also posited that it was “far more likely
than not B.D.’s symptoms were due to the Coronavirus OC43 in the context of his
underlying immunodeficiency.” Id. at 4.
In the ensuing status conference, Ms. Dotson expressed an intention to retain
a radiologist to review images. Ms. Dotson also planned to submit a short
supplemental report from Dr. Gershwin. See Order, issued June 3, 2020.
12 Whether Mr. Gage and Dr. Gershwin should be compensated and what a reasonable
amount of compensation would be for the largely ineffective efforts may depend upon the
Secretary’s position. See Vaccine Rule 13(a)(3).
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Ms. Dotson presented a seven-page report from David Wilson. Exhibit 54.13
Dr. Wilson presented his interpretations of various imaging studies. Id. at 2-4.
From this information and a limited amount of clinical information, Dr. Wilson
concluded that the most likely explanation for B.M.’s condition was a
“vasculopathy which may have been of infectious or immunogenic origin; however
this vasculopathy was almost certainly not caused by the cited pathogen OC43.”
Id. at 4. Dr. Wilson acknowledged that from “an imaging perspective, this is a
challenging case.” Id. Dr. Wilson’s report suggested different possible diagnoses
of 1) a vasculopathy, 2) a cerebritis/cerebellitis caused by an infectious agent, 3)
acute demyelinating injury, either ADEM or AHEM, and 4) embolic stroke. Id.
Dr. Wilson opined that since “increased signal on [diffusion-weighted imaging]
can be seen in demyelinating disease, and the relationship of injury to vaccine
administration, ADEM/AHEM is an important consideration in this case.” Id. at 6.
Dr. Wilson continued to state that the DWI signals seen are more consistent with
acute stroke than demyelinating disease. Id.
In conjunction with Dr. Wilson’s report, Ms. Dotson submitted another
report from Dr. Gershwin. In this one-page report, Dr. Gershwin essentially says
that he agrees with Dr. Wilson’s opinions and maintains his previously expressed
opinions. Exhibit 76.
In the next status conference, because Ms. Dotson had presented a report
from Dr. Wilson, the Secretary expressed an interest in obtaining a report from a
neuroradiologist. The Secretary also wanted to obtain a supplemental report from
Dr. Kruer. Order, issued Oct. 19, 2020.
The Secretary filed these two reports on January 6, 2021. Dr. Zucconi’s
January 6, 2021 report is nine pages. Like Dr. Wilson, Dr. Zucconi reviewed
images from various studies on B.M. Exhibit V at 2-6. Dr. Zucconi considered
different diagnoses. Ultimately, Dr. Zucconi concluded that “[a]cute viral
encephalitis is considered most likely” with HCoV-OC43 the “leading pathogen.”
Id. at 9.
The second report filed on January 6, 2021 was Dr. Kruer’s next report,
which is approximately six pages. Dr. Kruer stated that “Dr. Gershwin’s report did
13 Dr. Wilson’s first report was originally filed on September 30, 2020. But, one page
was illegible and it was struck. The legible version of Dr. Wilson’s first report was filed on
October 7, 2020.
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not contain new assertions.” Exhibit X at 1. Thus, Dr. Kruer’s opinions were
directed to Dr. Wilson.
With respect to diagnosis, Dr. Kruer found common ground in how Dr.
Wilson interpreted B.M.’s imaging. “I agree with Dr. Wilson’s assessment: BM’s
neuroimaging is highly unusual. It is not ‘typical’ of anything, and so we are very
likely to be dealing with either a rare disease, or an atypical manifestation of a
common disease, or some combination of the two.” Id. at 1. With this caveat, Dr.
Kruer confirmed his earlier opinion that the “most likely diagnosis” is “an atypical
coronavirus OC43 encephalitis in the context of an underlying immunodeficiency.”
Id. Dr. Kruer explained the bases for this opinion over the next four pages. Id. at
1-5.
Dr. Kruer also addressed the Althen factors briefly. He opined that the work
of Dr. Gershwin and Dr. Wilson were not sufficient to show that the varicella
vaccine caused B.M. to suffer vasculitis. Instead, the evidence was more
consistent with an OC43 infection. Id. at 5-6.
Another status conference was held. Ms. Dotson stated that she planned to
speak with Dr. Gershwin and Dr. Wilson about whether either or both would
respond. Ms. Dotson also inquired about setting a date for a hearing. However, a
hearing would not be set until after the parties advocated through briefs, which
would be after the experts had finished disclosing their opinions. See Order, issued
Jan. 15, 2021.
Ms. Dotson submitted another report from Dr. Gershwin, which was
approximately two pages. In conclusion, Dr. Gershwin “agree[d] B.M.’s
symptomologies are unusual but that they are consistent with a VZV
vasculopathy.” Exhibit 77 at 2.
A March 12, 2021 scheduling order required each party to act. Ms. Dotson
was directed to file updated medical records. The Secretary was directed to state
whether a response to Dr. Gershwin’s most recent report was required. The
Secretary did so and wanted to file additional reports. Resp’t’s Status Rep., filed
March 26, 2021.
The Secretary filed another pair of reports on May 21, 2021. Dr. Zucconi’s
two-page report addresses why a varicella infection was unlikely and why the
imaging supports acute viral encephalitis. Exhibit Y. Dr. Kruer challenges Dr.
Gershwin’s opinion that B.M. suffered from VZV vasculopathy. Exhibit Z.
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Due to the relative repetitiveness and brevity of the most recent reports, it
appeared that the case was likely to proceed to the briefing stage. As part of this
process, Ms. Dotson filed some updated medical records as well as school records.
Exhibits 80-82.
D. Addition of Dr. Shafrir and Development of More Expert
Opinions
In the June 23, 2021 status conference, Ms. Dotson proposed adding another
expert, a neurologist. In her view, Dr. Wilson’s experience as a neuroradiologist
did not exactly match the background of a neurologist. Although the Secretary did
not object---provided he was entitled to respond, the Secretary noted that in fall
2020, Mr. Gage seemed eager to set the case for a hearing. Because of an interest
in allowing Ms. Dotson to present her evidence, she was permitted to add another
expert.
Ms. Dotson submitted Dr. Shafrir’s first report on December 20, 2021.
Exhibit 84. Although this report is approximately 50 pages, the bulk (about 41
pages) summarize medical records through 2016. In the “discussion” section, Dr.
Shafrir mainly addressed diagnosis. Dr. Shafrir opined that three potential
diagnoses were ADEM, encephalitis, and vasculitis. Exhibit 84 at 43-44. Of these
choices, Dr. Shafrir stated that vasculitis was the most likely. Dr. Shafrir generally
agreed with Dr. Gershwin that the varicella vaccine was the most likely cause of
the vasculitis, although Dr. Shafrir’s opinion as to a potential causal connection
between the varicella vaccine and the vasculitis was not particularly robust. See id.
at 44-45. Dr. Shafrir also explained why acute viral encephalitis is not an
appropriate diagnosis. Id. at 45-46. Dr. Shafrir critiqued some aspects of Dr.
Kruer’s opinion. However, Dr. Shafrir declined to address immunological parts of
Dr. Kruer’s second report because Dr. Shafrir anticipated that Dr. Gershwin would
respond. Likewise, Dr. Shafrir did not discuss the radiology as addressed by Dr.
Wilson and Dr. Zucconi.
Again, the Secretary responded with a pair of reports. Perhaps not
surprisingly, given that Dr. Shafrir did not comment on the radiology, Dr. Zucconi
maintained his opinion, which was that B.M. had acute viral encephalitis caused by
a coronavirus. Exhibit AA.
Dr. Kruer’s six-page report responded to Dr. Shafrir, nearly paragraph-by-
paragraph. Dr. Kruer continued his opinions. Exhibit BB.
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The parties discussed the completeness of the expert reports in a May 4,
2022 status conference. Ms. Dotson stated that for expert opinions, the parties
have reached the bottom of the well. Thus, the next step was for the attorneys to
organize the evidence through briefs. See Order, issued May 5, 2022. A July 28,
2022 order offered some guidance with respect to the expected content of the
briefs. With respect to Althen prong one, which concerns a theory, Ms. Dotson
was directed to “begin by summarizing the theory explaining how the varicella
vaccine can cause cerebral vasculitis. The summary should not merely quote from
the expert reports.” Order, issued July 28, 2022, at 5. To the extent that she was
attempting to demonstrate the soundness and reliability of any opinion causally
connecting the varicella vaccine to vasculitis, the parties were directed to “include
at least one paragraph about the article.” Id. at 6.
Approximately only one week after the briefing order was issued, Ms.
Dotson filed another report from Dr. Shafrir. Exhibit 99. This report was five
pages and Dr. Shafrir cited eight articles.14 Dr. Shafrir concludes: “Dr. Kruer’s
report contains no data to cause one to believe that BM suffered from
coronaviruses OC43 encephalitis rather than CNS vasculitis.” Id. at 5.
The Secretary objected to the submission of a report from Dr. Shafrir.
Resp’t’s Status Rep., filed Aug. 15, 2022. A status conference was held on August
17, 2022. Ms. Dotson’s defended the submission because she had a right to submit
evidence. See Pet’r’s Status Rep., filed Aug. 17, 2022. Furthermore, the July 28,
2022 briefing order specifically authorizes parties to file a reasonable number of
medical articles when accompanied by a statement from an expert explaining them.
In contrast, the Secretary maintained that the filing of an additional expert report
after the briefing order issued frustrates the orderly presentation anticipated in the
briefing order. The Secretary also argued that the submission of another expert
report was inappropriate after Mr. Gage had represented in the May 4, 2022 status
conference that the experts were done.
The Secretary’s objection to Dr. Shafrir’s August 3, 2022 report was
overruled and this report remains in the record. The objection was overruled for
two reasons: first, the July 28, 2022 order for briefs did allow for supplementation
of expert reports and second, the Secretary would not be prejudiced. The Secretary
could respond with more reports from Dr. Kruer and Dr. Zucconi.
14 Dr. Shafrir, at times, criticizes Dr. Kreur with language that is potentially inflammatory
and excessively personal. Dr. Shafrir is expected to express his opinions more respectfully and
any counsel retaining Dr. Shafrir is also expected to monitor Dr. Shafrir’s writing.
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The Secretary did not file another report from Dr. Zucconi, probably
because Dr. Shafrir’s previous report did not really contest any opinions that Dr.
Zucconi made about the imaging. However, the Secretary obtained another report
from Dr. Kruer, which was filed on October 25, 2022. Attempting to refute Dr.
Shafrir’s criticisms, Dr. Kruer wrote approximately five more pages and cited five
more articles. Exhibit CC.
E. Summary of Expert Reports
Dr. Kruer’s report completed the submission of written reports from the
experts. This process began with Dr. Gershwin’s first report filed in April 2019.
The highlights of the expert reports are presented below:
# Ex. Party Author Summary
Diagnosis = vasculitis. Challenge to immune
1 18 P1 Gershwin
deficiency and coronavirus infection.
2 40 P2 Gershwin Althen prong 3.
Copied much of prior two reports. Added some
3 47 P3 Gershwin
on theory / Althen prong 1.
Diagnosis: coronavirus infection in context of
4 C R1 Kruer
immunodeficiency.
Review of imaging. Some discussion of Althen
5 P R2 Kruer
prongs.
Review of imaging. Diagnosis = vasculopathy.
6 54 P4 Wilson
Not coronavirus.
7 76 P5 Gershwin One page, agreeing with Dr. Wilson.
Review of imaging. Diagnosis = acute viral
8 V R3 Zucconi
encephalitis.
Diagnosis = atypical coronavirus encephalitis.
9 X R4 Kruer
Brief discussion of Althen prongs.
10 77 P6 Gershwin Diagnosis = VZV vasculopathy.
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# Ex. Party Author Summary
Two pages about images supporting acute viral
11 Y R5 Zucconi
encephalitis.
12 Z R6 Kruer Disputing diagnosis of VZV vasculopathy.
Detailed (40 pages) review of facts with
commentary. Vasculitis is most likely diagnosis.
13 84 P7 Shafrir
Little or nothing about immunology and
radiology.
Diagnosis: acute viral encephalitis caused by a
14 AA R7 Zucconi
coronavirus.
15 BB R8 Kruer Responding to Dr. Shafrir.
Briefing Order, filed July 28, 2022
Challenge to diagnosis of coronavirus
16 99 P8 Shafrir
encephalitis, rather than vasculitis.
17 CC R9 Kruer Responding to Dr. Shafrir.
F. Briefing Stage
After the parties finished disclosing the opinions from their experts, the next
step was for the attorneys to marshal the evidence. Order, issued July 28, 2022.
This process contained one wrinkle.
Ms. Dotson argued her case through a 40-page brief, filed Nov. 14, 2022.
Ms. Dotson began by suggesting that a hearing regarding only diagnosis was
appropriate. Although Ms. Dotson was “convinced” that the appropriate diagnosis
for B.M. was vasculitis, the Secretary was contending that B.M. suffered from an
encephalitis. Pet’r’s Br. at 1. Ms. Dotson proposed that if the evidence were found
to preponderate in favor of encephalitis as a diagnosis, then she “would present
evidence dealing with vaccine caused encephalitis.” Id. at 2.
This path was not contemplated in the July 28, 2022 briefing order. Thus,
the Secretary was directed to respond only this aspect of Ms. Dotson’s brief.
Order, issued Nov. 22, 2022.
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The Secretary objected to a plan in which entitlement could restart. Resp’t’s
Status Rep., filed Dec. 2, 2022. During a December 22, 2022 status conference,
Ms. Dotson withdrew her request for a hearing limited to diagnosis. However, she
maintained her request for a hearing. Order, issued Dec. 22, 2022. Because the
case was moving forward on all issues, the Secretary was directed to file his brief.
Id.
The Secretary argued against a finding of entitlement in a 51-page brief,
filed Jan. 31, 2023. The Secretary challenged (a) whether vasculitis was an
appropriate diagnosis, (b) whether Ms. Dotson met her burden with respect to a
theory, (c) whether Ms. Dotson met her burden with respect to a logical sequence
of cause and effect, and (d) whether Ms. Dotson met her burden with respect to
timing.
Ms. Dotson had what appeared to be the final word by filing a reply on
March 2, 2023. This reply was approximately 10 pages.
Typically, the submission of a reply makes the case ready for adjudication.
However, a preliminary review showed that Ms. Dotson had not articulated the
theory (or theories) by which a varicella vaccine can cause vasculitis. See Order,
issued Mar. 15, 2024. Thus, Ms. Dotson was directed to file a short memorandum.
Id. The March 15, 2024 order also specified that “If petitioner is advancing more
than one theory, petitioner shall separately number each theory.” She was also
instructed to tie up some loose ends, such as providing information about B.M.’s
experience with the coronavirus circulating during the pandemic.
Ms. Dotson attempted to take care of these matters. She submitted a status
report regarding theories. Pet’r’s Mem., filed Apr. 3, 2024. She explained that
B.M. has not tested positive for the current coronavirus. Exhibit 115 (affidavit).
The Secretary was permitted an opportunity to respond. Order, issued July
17, 2024 (also allowing Ms. Dotson to reply). The Secretary stated that he
previously addressed the failure of Ms. Dotson’s experts to present a cogent
medical theory. Resp’t’s Status Rep., filed Aug. 7, 2024, citing Resp’t’s Br. at 41-
45. The Secretary continued: “As to petitioner’s status report, she did not number
or name the theory or theories as instructed, and it is therefore not clear what
respondent should be addressing.” Id. The Secretary, nevertheless, made four
points as to why Ms. Dotson had not satisfied Althen prong one.
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Ms. Dotson was entitled to address these points through a reply brief. Order,
issued July 12, 2024. However, she did not. The lack of reply leaves many points
unrebutted. Regardless of the lack of reply, the case is ready for adjudication.
G. Adjudication without a Hearing
Special masters possess discretion to decide whether an evidentiary hearing
will be held. 42 U.S.C. § 300aa-12(d)(3)(B)(v) (promulgated as Vaccine Rule 8(c)
& (d)), which was cited by the Federal Circuit in Kreizenbeck v. Sec’y of Health &
Hum. Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2018). Here, a hearing is not
necessary to resolve Ms. Dotson’s case. Ms. Dotson has submitted eight reports
from experts and argued her case through briefs. She has had a full and fair
opportunity to establish that she is entitled to compensation.
III. Standards for Adjudication
A petitioner is required to establish her case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact's existence.” Moberly v. Sec’y of
Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &
Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.
Cir. 2009) (reversing special master's decision that petitioners were not entitled to
compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357
(Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.
Cir. 1993) (disagreeing with dissenting judge's contention that the special master
confused preponderance of the evidence with medical certainty).
Petitioners bear a burden “to show by preponderant evidence that the
vaccination brought about [the vaccinee’s] injury by providing: (1) a medical
theory causally connecting the vaccination and the injury; (2) a logical sequence of
cause and effect showing that the vaccination was the reason for the injury; and (3)
a showing of a proximate temporal relationship between vaccination and injury.”
Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
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IV. Analysis
Often, when the parties dispute the diagnosis, special masters resolve the
question of diagnosis first. As the Federal Circuit has explained, in some
circumstances, the special master may “first determine which injury was best
supported by the evidence in the record before applying the Althen test.”
Broekelschen v. Sec’y of Health and Hum. Servs., 618 F.3d 1339, 1346 (Fed. Cir.
2010). However, Ms. Dotson’s case is unusual in that (a) B.M.’s diagnosis is a
challenging question and (b) the case can be analyzed without resolving the
question of diagnosis. As demonstrated below, even if B.M. were assumed to have
vasculitis, Ms. Dotson’s case still falters.
Ms. Dotson has failed to meet all the elements necessary to show that the
varicella vaccine was the cause-in-fact of (an assumed) vasculitis. In most cases,
the prong one inquiry is distinct from the prong two question. The former is about
general causation, and the latter is about specific causation. Piscopo v. Sec’y of
Health & Hum. Servs., 66 Fed. Cl. 49, 54 (2005). For Ms. Dotson, the separation
is not so stark. Her attempts to present a creditable prong one theory were largely
unsuccessful, negating the need for an extensive prong two analysis. To the extent
that Ms. Dotson has presented a passable prong one theory, her case falls apart at
prong two.
A. Althen Prong One - Theory
After multiple rounds of expert reports and rounds of briefing, whether Ms.
Dotson has disclosed any theory is debatable. Ms. Dotson was notified repeatedly
that the presentation of any theory was not adequate. She did largely not cure this
deficiency. See Section IV.A.1. below.
To be fair, Ms. Dotson has not ignored her obligation to present a theory
entirely. She has cited a handful of articles. This evidence is reviewed in Section
IV.A.2, below.
An assessment of the evidence Ms. Dotson has advanced reveals that for the
most part, the evidence falls short of meet her burden. Potentially, one theory may
be viable. See Section IV.A.,3, below. But, that theory (a direct viral invasion)
does not help Ms. Dotson establish that the varicella virus harmed B.M. See
Section IV.B., below.
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1. Opportunities to Disclose a Medical Theory
Represented by attorneys with experience in the Vaccine Program (Ms.
Toale and Mr. Gage), Ms. Dotson knew that to prevail in this litigation she was
required to present “a medical theory causally connecting the vaccination and the
injury.” Althen, 418 F.3d at 1278. This requirement was reinforced in final
Instructions for experts, issued December 12, 2017.
Dr. Gershwin’s first two attempts to put forward a minimally competent
medical theory fell well short. After Dr. Gershwin wrote his May 14, 2019 report,
the Secretary argued that the case should be dismissed. Resp’t’s Mot., filed May
29, 2019. Ms. Dotson did not attempt to defend the adequacy of this report.
Instead, she added a second report. Any disclosure in the second report was also
deficient as explained in the Second Order to Show Cause, issued Sep. 6, 2019.
This Second Order to Show Cause explained that Ms. Dotson was unlikely to
prevail if her expert advanced a theory based upon either a varicella infection or a
hypersensitivity reaction. Id. at 3.
Dr. Gershwin’s third report was sufficiently improved that the case could
proceed. Dr. Gershwin appeared to have disclosed the theory of molecular
mimicry. Exhibit 47 at 6, see also Order, issued Oct. 23, 2019 (memorializing
discussions in a status conference in which Mr. Gage stated that Dr. Gershwin was
advancing molecular mimicry).
However, this disclosure appeared not apparent to Dr. Kruer. In Dr. Kruer’s
second report, he asserted that Dr. Gershwin “has not proffered a theory of
causality.” Exhibit P at 3.
After Dr. Kruer’s second report, the parties added more reports. However,
these reports generally focused on diagnosis. See Section III.C., above (describing
procedural history). Although Dr. Gershwin wrote more reports, Dr. Gershwin did
not address Dr. Kruer’s comment that he (Dr. Gershwin) did not disclose a theory.
See Exhibit 76 (one page report from Dr. Gershwin agreeing with Dr. Wilson
about diagnoses), Exhibit 77 (Dr. Gershwin maintaining the diagnosis of VZV
vasculopathy).
Conceivably, Ms. Dotson’s addition of Dr. Shafrir might have assisted her
with meeting her burden for Althen prong one. See Thompson v. Sec’y of Health
& Hum. Servs., No. 15-671V, 2023 WL 21234 (Fed. Cl. Spec. Mstr. Jan. 3, 2023);
Quinones v. Sec’y of Health & Hum. Servs., No. 11-154V, 2019 WL 4745123
(Fed. Cl. Spec. Mstr. Sep. 4, 2019). However, Dr. Shafrir’s first and lengthy report
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also focused on diagnosis. Exhibit 84. At best, Dr. Shafrir discussed the potential
causal association between the varicella vaccine and vasculitis in two paragraphs.
Id. at 44. These two paragraphs do not meaningfully advance Ms. Dotson’s
evidence as Dr. Shafrir begins by stating “As indicated by Dr. Gershwin . . .” Id.
Dr. Shafrir cites two articles, which Dr. Gershwin had already cited. Two pages
later, Dr. Shafrir essentially repeats these two paragraphs. Id. at 46. This was the
last expert report to comment upon a prong one theory as Dr. Shafrir’s second
report again was about diagnosis. See Exhibit 99.
When the parties were instructed to brief the issues, Ms. Dotson was
reminded to set forth the theory or theories on which she was asserting. Order,
issued July 28, 2022. Both parties were directed to identify the articles that
supported or detracted from the soundness of any medical theory. Id. at 6.
In Ms. Dotson’s brief, she discussed Althen prong one in approximately two
double-spaced pages. Pet’r’s Br. at 36-38. This section begins “There is abundant
evidence linking varicella to vasculitis. The literature treats it as a given.” Id. at
36. She did not identify any theory. For example, although Mr. Gage had
represented in the October 23, 2019 status conference that Dr. Gershwin was
asserting molecular mimicry, the term “mimic” does not appear in this brief. Ms.
Dotson did, however, write a paragraph or two paragraphs about four articles---
Gilden (Exhibit 51),15 Nagel (Exhibit 33),16 Strauss (Exhibit 46),17 and Agger
(Exhibit 95).18
In response, the Secretary generally argued that these four articles did not
support Ms. Dotson’s claim. Resp’t’s Br. at 42-43. In doing so, the Secretary
commented that as “Dr. Kruer has noted, petitioner has not offered any cogent
theory of causation.” Id. at 43, citing, among other items, Exhibit P at 3.
15 Don Gilden et al., Varicella zoster virus vasculopathies: diverse clinical manifestations,
laboratory features, pathogenesis, and treatment, 8 LANCET NEUROL. (2009); filed as Exhibit 51.
16 Maria A. Nagel & Don Gilden, Developments in Varicella Zoster Virus Vasculopathy,
16 CURR. NUEROL. NUEROSCI. REP. (2016); filed as Exhibit 33.
17 Stephen E. Straus, Varicella-Zoster Virus Infections, 108 ANNALS OF INTERNAL
MEDICINE 221 (1988); filed as Exhibit 46.
18 William A. Agger et al., Increased Incidence of Giant Cell Arteritis After Introduction
of a Live Varicella Zoster Virus Vaccine, OPEN FORUM INFECTIOUS DISEASES (2020); filed as
Exhibit 95.
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Ms. Dotson seems to have attempted to address this point. She block-quoted
a portion of Dr. Gershwin’s third report, which contains the term “molecular
mimicry.” Pet’r’s Reply at 2. (The lengthy quotation is inconsistent with the July
28, 2022 briefing order, which directed the parties not to quote from the expert’s
reports). In this context, Ms. Dotson did not discuss any additional articles. (The
block quote actually eliminated references within Dr. Gershwin’s report).
To ascertain whether Ms. Dotson had presented any medical theory, an order
was issued for clarification from Ms. Dotson. Order, issued March 24, 2024. Ms.
Dotson was instructed to specify the theories on which she was relying.
Ms. Dotson repeated a block quote from Dr. Gershwin’s second report and,
this time, included two references, references 5 and 6. Pet’r’s Status Rep., filed
Apr. 3, 2024, at 1. For sake of completeness, Ms. Dotson’s argument is
reproduced in full:
“It should be emphasized that vasculitis are a very
heterogeneous group of rare diseases that are typically
classified based on the size of the blood vessel involved
and the anatomic location. In all cases, there is significant
inflammation, which is driven by mononuclear cells
and/or immune complex-mediated inflammatory
processes. The occurrence herein within 4 weeks would
be consistent with either mechanism, i.e. either the
production of mononuclear cells specific for vascular
antigens, the presence of crossreactive antibodies, i.e.
molecular mimicry, and /or antibody-[dependent] cells-
mediated cytotoxicity (5,6).”
Pet’r’s Status Rep., filed Apr. 3, 2024, at 1, quoting Exhibit 40 (Dr. Gershwin’s
June 18, 2019 report) at 1. Reference 6 is an article by Guillevin (Exhibit 41).19
Ms. Dotson did not elaborate on any argument based upon reference 5, which is an
article by Rojas and filed as Exhibit 45.20 Ms. Dotson’s status report also includes
19 Loic Guillevin & Thomas Dörner, Vasculitis: mechanisms involved and clinical
manifestations, 9 ARTHRITIS RESEARCH & THERAPY (2007); filed as Exhibit 41.
20 Manuel Rojas et al., Molecular mimicry and autoimmunity, 95 J. OF AUTOIMMUNITY
100 (2018); filed as Exhibit 45.
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a block quote from Twilt (Exhibit 87).21 Ms. Dotson included about one sentence
from three other articles: Cellucci & Benseler (Exhibit 98), Nagel & Gilden
(Exhibit 33) and Wise (Exhibit 37).22 Finally, without any descriptive information,
she cited eight other articles. She wrote: “Also see Exhibits 34, 35, 50, 71, 72, 73,
78 and 87.” Pet’r’s Status Rep., filed Apr. 3, 2024, at 1.23
21 Marinka Twilt & Susanne M. Benseler, CNS vasculitis in children, 2 MULTIPLE
SCLEROSIS AND RELATED DISORDERS 162 (2012); filed as Exhibit 87.
22 Robert P. Wise et al., Postlicensure Safety Surveillance for Varicella Vaccine, 284 J.
OF THE AM. MED. ASS’N 1271 (2000); filed as Exhibit 37.
23 In other briefs, Ms. Dotson slightly developed arguments based upon two articles,
which are Exhibit 34 (Nagel and Bubak) and Exhibit 87 (Twilt and Benesler). These two articles
are consequently discussed below.
For the remaining articles in this string cite, Ms. Dotson’s citation to the articles without
any explanation of their relevance could justify striking the articles. See Sheller v. Sec’y of
Health & Hum. Servs., 121 F.4th 1301, 1309 (Fed. Cir. 2024); Order for Briefs, issued July 28,
2022, at 6 (“for every article that the party finds relevant, the brief will include at least one
paragraph about the article. . . . Conversely, the omission of an article from the brief is likely to
be interpreted as an indication that the article is not important. Unimportant articles are subject to
being struck from the record”).
Nevertheless, out of an abundance of caution, the undersigned has reviewed these
articles. In absence of any advocacy from Ms. Dotson, the undersigned recognizes that three of
the six remaining articles appear to discuss how a varicella infection is associated with a
vasculitis. These are Exhibit 50 (Isabella Uhoda, Varicella-Zoster Virus Vasculitis: A Case of
Recurrent Varicella without Epidermal Involvement, 200 DERMATOLOGY 173 (2000)); Exhibit
72 (Maria A. Nagel and Don Gilden, Developments in Varicella Zoster Virus Encephalopathy,
16(12) CURR NEUROL NEUROSCI REP 11 (2016)); Exhibit 78 (Don Gilden et al., Varicella zoster
virus vasculopathies: diverse clinical manifestations, laboratory features, pathogenesis, and
treatment, 8(8) LANCET NEUROL. 731 (2009)). These three articles, which have some overlaps in
authorships, largely repeat information presented in other articles discussed in the text.
At least two of the cited, but undiscussed, articles focus on conditions not at issue in Ms.
Dotson’s case. See Exhibit 71 (Elaine Wirrell, Stroke after Varicella Vaccination, 145 J.
PEDIATRICS 845 (2004)) and Exhibit 73 (Til Menge, Acute Disseminated Encephalomyelitis, 62
ARCH NEUROL 1673 (2005)). Ms. Dotson has not persuasively explained why B.M.’s asserted
condition is analogous to either stroke or acute disseminated encephalomyelitis.
The final cited, but undiscussed, article, is a case report concerning a different vaccine.
Exhibit 35 (Vikram Puram et al., A Unique Case Report on Hypersensitivity Vasculitis as an
Allergic Reaction to the Herpes Zoster Vaccine, 53(1) VASCULAR AND ENDOVASCULAR
SURGERY 78 (2019)). In general, case reports provide little, if any, information helpful to
determining causation because they present only a temporal sequence of events in which the
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The Secretary maintained that Ms. Dotson’s experts have “fail[ed] to put
forward a cogent medical theory that causally connects the varicella vaccine to
vasculitis.” Resp’t’s Status Rep., filed Aug. 7, 2024, at 2. The Secretary also
pointed out that Ms. Dotson did not comply with the requirement in the March 15,
2024 order that she separately number the theories she was asserting.
Ms. Dotson had one final chance to identify the theories she was asserting
by filing a reply brief. See Order, issued July 12, 2024. However, she was silent.
Given these opportunities, Ms. Dotson’s lack of clarity about the theory (or
theories) is detrimental to her case. Presenting a sound and reliable theory is
essential to Ms. Dotson’s case. A theory causally connecting the vaccine to the
injury is the first Althen prong. When petitioners fail to establish this element,
compensation is denied. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d
1351, 1360-62 (Fed. Cir. 2019). Moreover, the theory advanced for Althen prong
one influences the remaining two Althen prongs. For the second Althen prong,
which addresses whether a logical sequence connects the vaccine to the injury,
special masters may consider whether the vaccinee responded in a way consistent
with the theory being offered. Hibbard v. Sec’y of Health & Hum. Servs., 698
F.3d 1355, 1364 (Fed. Cir. 2012); Miller v. Sec’y of Health & Hum. Servs., 172
Fed. Cl. 762, 784 (2024) (finding special master did not err in denying entitlement
when petitioner did not establish that she had immune complexes after asserting a
theory involving immune complexes); Dodd v. Sec’y of Health & Hum. Servs.,
114 Fed. Cl. 43, 52-57 (2013); La Londe v. Sec’y of Health & Hum. Servs., 110
Fed. Cl. 184, 205 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). Similarly, the
third Althen prong, which concerns timing, depends, at least in part, upon the
theory being offered. Langland v. Sec’y of Health & Hum. Servs., 109 Fed. Cl.
421, 443 (2013); see also Koehn v. Sec’y of Health & Hum. Servs., 773 F.3d 1239,
1244-45 (Fed. Cir. 2014) (holding that special master was not arbitrary in finding
an onset of injury seven months after vaccination was incompatible with a theory
based upon cytokines). Without a defined theory, attempting to determine whether
preponderant evidence supports the logical sequence or timing is difficult or
impossible.
Consistent with an obligation to resolve cases based upon the entire record
(42 U.S.C. § 300aa–13(a)), the undersigned has attempted to discern the theory (or
vaccination preceded an adverse health event. See K.O. v. Sec’y of Health & Hum. Servs., No.
13-472V, 2016 WL 7634491, at *11-12 (Fed. Cl. Spec. Mstr. July 7, 2016) (discussing appellate
precedent on case reports).
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theories) that Ms. Dotson is advancing. The undersigned took the unusual step of
giving Ms. Dotson and her attorney, Mr. Gage, a second opportunity to clarify her
theory by issuing the March 15, 2024 order.
In response to the direct question contained in the March 15, 2024 order
(what is petitioner’s theory or theories?), Ms. Dotson should have provided a direct
answer. She did not. This vagueness does not help her case. Judicial officers “are
not like pigs hunting for truffles buried in briefs.” Parus Holdings, Inc. v. Google,
L.L.C., 70 F.4th 1365, 1371-72 (Fed. Cir. 2023); Pipes v. United States, 123 F.4th
1324, 1331 (Fed. Cir. 2024); accord Wheless v. United States, 173 Fed. Cl. 215,
227 (2024) (“The Court cautions parties against throwing half-baked arguments
against the wall to see if the Court will do the work to make them stick”).
2. Articles Ms. Dotson Has Discussed
As extensively discussed above, Ms. Dotson’s presentations made in reports
from her experts and in briefs are far from a model of clarity. Nevertheless, she
has advanced some articles.
a) Wise and Epidemiological Studies
A primary piece of evidence is the article by Wise.24 Dr. Gershwin cited
that article in his first report and his third report. See Exhibit 18 at 5 (reference
13), Exhibit 47 at 5 (exhibit 37). Ms. Dotson did not cite this article in her brief or
her reply. However, in the April 3, 2024 status report, she asserted that the authors
reported cases of vasculitis after a varicella vaccine.
In this article, Robert P. Wise and colleagues searched Vaccine Adverse
Event Reporting System (VAERS). “VAERS data are typical of passive drug
safety surveillance programs.” Exhibit 37 at 1272. For reports filed between
March 17, 1995 through July 25, 1998, the researchers searched for diseases that
were reported to develop after a varicella vaccine. Id. They found 15 cases of
vasculitis. Id. at 1273 (Table 2). “Among 15 vasculitis reports, 3 children aged 1
to 3 years appeared to have Kawasaki syndrome, and 10 patients developed
Henoch-Schönlein purpura within 7 weeks of vaccination.” Id. at 1275. The
authors recognized several “inherent limitations” of VAERS data. Id. at 1276.
24 Although Ms. Dotson characterizes Wise as an epidemiological study, Wise did not
contain any controls. Thus, whether Wise is a “study” of any type is questionable.
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They proposed additional research, including projects involving the Vaccine Safety
Datalink Project. Id. at 1278.25
The Secretary’s expert, Dr. Kruer, criticized this article for its “major
confounding factors and the lack of a control group.” Exhibit BB at 2. Dr. Kruer
cited a different study by Di Pietrantonj.
The Di Pietrantonj article is relatively long, exceeding more than 400 pages,
according to its Table of Contents. (The Secretary excerpted 86 pages in Exhibit
BB, tab 2.)26 A review of this article did not readily identify any places in which
the authors assessed whether the varicella vaccine can cause vasculitis.27 Thus,
from one perspective, Dr. Kruer is correct in asserting that “no evidence linking
varicella vaccine . . . to vasculitis was identified.” Exhibit BB at 2. However, the
“no evidence” could reflect a lack of studies investigating this possibility.
Therefore, this Di Pietrantonj article does not undermine the claim that a varicella
vaccine can cause vasculitis.28
The relative weakness of the Di Pietrantonj article does not elevate the value
of the Wise article. Wise’s methodology of extracting data from the VAERS
database is not reliable. See H.L. v. Sec’y of Health & Hum. Servs., 715 Fed.
App'x 990, 995-96 (Fed. Cir. 2017); Analla v. Sec’y of Health & Hum. Servs., 70
Fed. Cl. 552, 558 (2006).
Through Dr. Shafrir, Ms. Dotson advanced an epidemiologic study in which
researchers investigated whether a live attenuated herpes zoster vaccine (ZVL)
affected the incidence of giant cell arteritis. Exhibit 95 (Agger); see also Exhibit
84 (Dr. Shafrir’s report) at 45; Pet’r’s Br. at 37. Giant cell arteritis “causes
inflammation in the walls of medium and large elastic arteries of the head.”
25 In a different case, Dr. Wise testified that his purpose in writing this article was to
summarize adverse events. Casey v. Sec’y of Health & Hum. Servs., No. 97-612V, 2005 WL
3597263, at *14 (Fed. Cl. Spec. Mstr. Dec. 12, 2005).
26 Carlo Di Petrantonj et al., Vaccines for measles, mumps, rubella, and varicella in
children, 11 COCHRANE DATABASE SYST. REV. (2021); filed as Exhibit BB, tab 2.
27 The authors had “low” certainty about a finding that the mumps-measles-rubella
vaccine could cause Henoch-Schönlein purpura. Exhibit BB, tab 2 at 21 (finding 14), 56.
However, Ms. Dotson has not claimed that the MMR portion of the Pro-Quad vaccine that her
son received harmed him.
28 By way of contrast, studies investigated whether MMR vaccines are associated with
autism and did not find a link. See Exhibit BB, tab 2 at 21 (finding 9).
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Exhibit 95 at 1. People who suffer from giant cell arteritis are usually older than
50 years. Id. at 2 (discussing diagnostic criteria). All the people in this study were
at least 60 years old. Id. (discussing population). The researchers found that the
“ZVL vaccination was associated with an increased risk of GCA diagnosis.” Id. at
3. The authors explained that the “association may potentially be attributed to (1)
subacute or persistent arterial wall infection with ZVL, (2) a ZVL vaccine-driven
cellular immune response to VZV already present in the arterial walls, or (3) a non-
viral specific autoimmune reaction triggered by ZVL.” Id. at 4.
Dr. Kruer distinguished the Agger study on giant cell arteritis because giant
cell arteritis “is essentially unheard of in children.” Exhibit CC at 3. Thus, in Dr.
Kruer’s view, the Agger study holds “doubtful relevance to this case as BM was a
small child at the time his injury occurred.” Id.
Although an affirmative epidemiological study could have helped Ms.
Dotson establish that the varicella vaccine can cause vasculitis, the Wise study is
not persuasive evidence for this proposition. See Stapleford v. Sec’y of Health &
Hum. Servs., No. 03-234V, 2009 WL 1456441, at *8 (Fed. Cl. Spec. Mstr. May 1,
2009) (finding that petitioner did not establish that a varicella vaccine caused a
seizure disorder and discussing Wise). But the lack of an epidemiological study
does not doom the claim because a petitioner is not required to present an
epidemiologic study. Althen, 418 F.3d at 1280.
b) Nagel and Gilden / Exhibit 33
Dr. Gershwin cited this article as reference 15 in his first report. Exhibit 18
at 5. After Ms. Dotson filed it as exhibit 33, Dr. Gershwin again cited it in his
third report. Exhibit 47 at 5. Ms. Dotson cited this article. Pet’r’s Br. at 36-37;
Pet’r’s Status Rep. at 3.
In this article, the co-authors focused on the association of varicella zoster
virus and stroke. A stroke is due to “productive VZV infection of cerebral
arteries.” Exhibit 33 (Nagel and Gilden) at 1.29 The authors elaborated that “VZV,
a highly neurotrophic member of the herpes family, is the only human virus that
has been shown to replicate in arteries and produce disease.” Id. at 2. Under
pathogenesis, the article states: “After reactivation from cranial nerve ganglia,
VZV likely spreads transaxonally to the outermost adventitial layer of the artery
wall; infected cerebral arteries contain a thickened intima composed of
29 Ms. Dotson submitted a manuscript version, not a copy of the article as it appears in
publication.
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myofibroblasts, a disrupted internal elastic lamina, and a paucity of smooth muscle
cells.” Id. at 3.
The Nagel and Gilden article also discussed varicella vaccines and
vasculopathy. The article distinguished between the Zostavax vaccine, which is
given to adults to prevent shingles, and Varivax, which is given to children. The
authors cited one report in which two children developed ischemic strokes 5 days
and 3 weeks after a varicella immunization. Id. at 4. In a third case, an
immunocompromised child developed multifocal large artery vasculopathy after a
varicella vaccine. Id.
c) Strauss / Exhibit 46
Dr. Gershwin cited this article in his second report (Exhibit 40 at 2
(reference 1)) and in his third report (Exhibit 47 at 7). Ms. Dotson cited this
article. Pet’r’s Br. at 37.
This article reported a complication of a zoster infection was
cerebrovasculopathy. Exhibit 46 at 228. The references supporting this assertion
are from 1983 and 1986.
With respect to live varicella vaccines, the article reported some side effects.
However, vasculitis does not appear among them. Exhibit 46 at 233-34.
d) Gilden / Exhibit 51
Dr. Gershwin cited this article in his third report as supporting an asserting
that “vascular lesions produced by Varicella are reflective of a productive viral
infection in cerebral arteries.” Exhibit 47 at 7. Gilden corroborates this assertion
as the article states “VZV vasculopathy is caused by productive viral infection in
arteries.” Exhibit 51 at 8.30
e) Nagel and Bubank / Exhibit 3431
Dr. Gershwin cited this article (reference 12) in his first report in support of
a statement that in 13 cases, children who received varicella vaccine were reported
to develop vasculitis. Exhibit 18 at 5. In his third report, Dr. Gershwin again cited
30 Ms. Dotson filed a manuscript version of this article.
31 Maria A. Nagel & Andrew N. Bubak, Varicella Zoster Virus Vasculopathy, 218 J. OF
INFECTIOUS DISEASES 107 (2018); filed as Exhibit 34. This article was also filed as Exhibit 57.
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this report. Exhibit 47 at 7. Ms. Dotson cites this article only twice in her brief.
The information in this article resembles the information presented in Nagel and
Gilden article.
f) Rojas / Exhibit 45 & Guillevin / Exhibit 41
In the context of Althen prong three, Dr. Gershwin cited these two articles as
references 5 and 6, respectively. Exhibit 40 at 1. Dr. Gershwin wrote that the
development of vasculitis within four weeks of the vaccination “would be
consistent with either mechanism, i.e. either the production of mononuclear cells
specific for vascular antigens, the presence of cross-reactive antibody, i.e.
molecular mimicry, and/or antibody-dependent cell-mediated cytotoxicity.” Id.
When called upon to present a comprehensive opinion, Dr. Gershwin
slightly revised this portion. Again, Dr. Gershwin cited these articles in the
context of Althen prong three. He wrote: “The mechanism herein is similar to
other causes of vasculitis. . . . priming and generation of mononuclear cells that
cross react with Varicella antigens found in blood vessels.” Exhibit 47 at 6
(ellipses in Dr. Gershwin’s report). This reference to “cross react” is consistent
with molecular mimicry, which was mentioned in the second report.
These articles are absent from Ms. Dotson’s primary brief. However, the
March 1, 2023 reply block-quoted from Dr. Gershwin’s third report, including the
passage about “cross react.” Pet’r’s Reply at 2. However, Ms. Dotson otherwise
did not expand upon what theory or theories the Rojas article and the Guillevin
article supported. Ms. Dotson’s April 3, 2024 status report quotes one sentence
from the Guillevin article and does not discuss the Rojas article.
Rojas article has limited usefulness in providing a theory to explain how
varicella vaccine can cause vasculitis in Ms. Dotson’s case. Manuel Rojas and
colleagues (including Dr. Gershwin) discussed how infections may induce
autoimmune diseases through molecular mimicry. Exhibit 45. They detail
evidence in approximately a dozen diseases, but none are vasculitis. See id. at 4-9.
The other article Dr. Gershwin in this context is by Loic Guillevin and
Thomas Dörner. Ms. Dotson quoted, accurately, a passage from the abstract:
“Various pathogenic mechanisms have been implicated in the induction of
vasculitis, including cell-mediated inflammation, immune complex-mediated
inflammation and autoantibody-mediated inflammation.” Exhibit 41 at 1. The
authors provided examples of each potential pathogenesis: cell-mediated
inflammation is for giant cell arteritis, immune complex-mediated inflammation is
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for Henoch-Schönlein purpura, and autoantibodies for necrotizing
glomerulonephritis. Id. at 2. This division suggests that different diseases have
different pathologic pathways. Guillevin and Dörner did not discuss varicella as an
inciting agent.
g) Celluci and Benesler / Exhibit 98 & Twilt and Beneseler /
Exhibit 87
The discussion of potential pathologic mechanisms in Guillevin and Dörner
resembles, in some respects, two other articles Ms. Dotson put forward: an article
by Tania Cellucci and Sussane M. Benseler (Exhibit 98) and an article by Marinka
Twilt and Susanne M. Benseler (Exhibit 87). See Pet’r’s Status Rep., April 3,
2024, at 2-3. Dr. Shafrir cited Cellucci and Benseler as well as Twilt and Benseler
to support his opinion that a person can be suffering from vasculitis in the central
nervous system even if an angiography is negative. Exhibit 84 at 45, 48. In other
words, Dr. Shafrir was relying upon these articles for diagnosis, not a theory.
Nonetheless, Ms. Dotson quoted the Cellucci and Benseler article as saying “CNS
vasculitis secondary to infection may result from direct pathogen invasion of the
vessels or may be due to an immune-mediated response provoked by molecular
mimicry, immune complex deposition, secretion of cytokines, and/or superantigen-
mediated responses.” Exhibit 98 at 733. The Twilt and Benseler article, in turn,
also discussed different methods by which vasculitis might develop:
Activated immune cells, such as T- and B-cells, and
macrophages can cause an inflammatory response with
production of cytokines and antibodies which can target
different brain structures such as specific segments of
blood vessels, neurons, or CNS proteins such as myelin,
cell surface receptors, channels or enzymes.
Inflammatory pathways can then be activated and cause
characteristic clinical, radiographic and histological
findings.
Exhibit 87 at 163. In the preceding sentence, the authors stated that “Inflammatory
brain diseases represent a spectrum of illnesses that can occur in the context of an
underlying focal or systemic condition (secondary Inflammatory brain diseases)
such as an infection.” Id.
This concludes the set of articles about which Ms. Dotson wrote at least one
sentence in the context of Althen prong one.
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3. Assessment
As noted earlier, neither the Wise article nor the Agger study carry Ms.
Dotson’s burden to demonstrate that the varicella vaccine can cause vasculitis.
The analysis of that evidence will not be repeated in this section. Instead, this
section focuses upon the theories that potentially have been advanced. They are
organized into two categories: first, a bucket of other theories and second, the
direct viral invasion theory.
a) Miscellaneous Theories
Except for a theory based upon direct viral invasion, which is discussed
below, any other theories were presented in such an abbreviated form that they are
not sound and reliable. Examples include molecular mimicry, immune complexes,
and cytokines.
Molecular Mimicry. Molecular mimicry often appears as a theory in
Vaccine Program cases See Hoffman v. Sec’y of Health & Hum. Servs., No. 19-
111V, 2024 WL 4444773 (Fed. Cl. Spec. Mstr. Sept. 13, 2024) (appendix listing
cases). The Rojas article demonstrates that some people in the medical community
propose molecular mimicry as a theory to explain how some autoimmune diseases
develop. Exhibit 45.
It is also the case that Dr. Gershwin’s reports at least mention the idea. His
second report includes the phrase “the presence of cross-reactivity antibody, i.e.
molecular mimicry” in the context of Althen prong three. Exhibit 40 at 1.
Likewise, Dr. Gershwin’s third report uses the phrase “cross react with Varicella
antigens.” Exhibit 47 at 6. This phrase was included as part of a block quote when
Ms. Dotson was advocating. Pet’r’s Reply at 2.
Ms. Dotson’s evidence and arguments regarding molecular mimicry are too
general to be persuasive. Special masters are not arbitrary in refraining from
crediting an opinion based upon molecular mimicry when the petitioner’s expert
“never actually explains how molecular mimicry might occur from the [relevant]
vaccine specifically.” Dennington v. Sec’y of Health & Hum. Servcs., 167 Fed. Cl.
640, 653 (2023), app dismissed, No. 24-1214, 2024 WL 1255318 (Fed. Cir. 2024).
Immune Complexes. Like molecular mimicry, the theory of immune
complexes has appeared in Vaccine Program cases. E.g. Miller, 172 Fed. Cl. at
784 (denying motion for review when petitioner did not establish that she suffered
from immune complexes). However, the evidence about immune complexes as a
way to explain how a varicella vaccine can cause vasculitis in this case is meager.
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To start, Dr. Gershwin wrote about “immune complexes” in one sentence of
his second report and repeated this sentence in his third report. See Exhibits 40 at
1 and Exhibit 47 at 6. Otherwise, he did not elaborate. The theory of immune
complexes is mentioned in at least two articles. The Celluci & Benseler article
mentions “immune complex deposition” as one of several methods by which CNS
vasculitis might originate. Exhibit 98 at 733. However, this article does not
propose that any immune complexes would involve a vaccine.
The other article proposing immune complexes as a way to explain some
forms of vasculitis is by Guillevin and Dorner. Exhibit 41 at 1. These authors
state that inflammation mediated by immune complexes causes Henoch-Schönlein
purpura. Exhibit 41 at 2. However, again, the authors do not link the creation of
immune complexes with vaccines. Moreover, Ms. Dotson has not presented
persuasive evidence that Henoch-Schönlein purpura is analogous to CNS
vasculitis.
Cytokines. A third theory that arguably is in play involves cytokines.
However, the source of information about cytokines in this case is not Dr.
Gershwin. None of his three reports use the term cytokines. See Exhibits 18, 40,
and 47. Because petitioners must rely upon medical records or medical opinions
(42 U.S.C. § 300aa–13(a)), the lack of disclosure from Dr. Gershwin appears to
prevent Ms. Dotson from prevailing on this theory. See Vaccine Rule 8(f)(1).
Rather, the term “cytokines” appears in two articles, which Dr. Shafrir cited
regarding diagnosis. See Exhibit 98 (Cellucci and Benseler) at 733, Exhibit 87
(Twilt and Benseler) at 163.
Evaluation. These theories lack sufficient development. One sentence or
two sentences do not establish the soundness of any of them.
The Court of Federal Claims has ruled that special masters are not arbitrary
when they reject unsubstantiated theories. Examples include: Temes v. Sec’y of
Health & Hum. Servs., 151 Fed. Cl. 448, 461 (2020) (“Dr. Bellanti did not provide
any support—by way of medical literature or otherwise—for his opinion that either
molecular mimicry or bystander activation played a role”); Shapiro v. Sec’y of
Health & Hum. Servs., 105 Fed. Cl. 353, 359 (2012) (agreeing with special
master’s assessment that petitioner’s expert’s presentation of some theories was
“extremely cursory”), aff’d without op., 403 Fed. App’x 952 (2013); see also
Baron v. Sec’y of Health & Human Servs., No. 14-341V, 2019 WL 2273484, at
*17 (Fed. Cl. Spec. Mstr. Mar. 18, 2019) (petitioners “need to propose something
more than taking a vague ‘kitchen sink’ approach and listing eleven mechanisms
that have been previously submitted in the Program for claims of vaccine-caused
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injury with various degrees of success. Petitioners have listed many possibilities
but have not identified a sound and reliable explanation that can be applied to the
vaccines and injury in this case”).
Accordingly, molecular mimicry, immune complexes, and cytokines are
found to be inadequate under Althen prong one due to the lack of evidence
supporting their reliability as a means to explain how the varicella vaccine can
cause vasculitis.
b) Direct Viral Invasion
According to some articles, a varicella infection may lead to complications
because the infection is “productive.” Exhibit 33 (Nagel & Gilden) at 1. Because
the varicella vaccine contains a live, but attenuated, virus, a theory that the
varicella vaccine can cause an injury that the virus itself can cause seems to
possess some minimal amount of soundness and reliability.
A greater amount of disclosure from Ms. Dotson’s experts could have
enhanced the value of the theory. Nevertheless, if only for the sake of advancing
the analysis, it is assumed that (a) Ms. Doston intended to advance “viral infection”
as a theory to explain how the varicella vaccine can cause vasculitis and (b) this
theory satisfies the first prong of Althen. See Astle v. Sec’y of Health & Hum.
Servs., No. 14-369V, 2018 WL 2682974, at *21 (Fed. Cl. Spec. Mstr. May 15,
2018) (stating that the varicella virus “is known to infect nerves and blood vessels
in the brain”).32
B. Althen Prong Two
As alluded to earlier, presenting an adequate theory under Althen prong one
is an essential prerequisite to assessing whether a petitioner has met the burden
with respect to a logical sequence of cause and effect. “The causal theory accepted
under the first prong determines which theory of causation the special master must
consider under the second prong.” Quintana v. Sec’y of Health & Hum. Servs.,
No. 15-1273V, 2022 WL 1873849, at *10 (Fed. Cl. 2022); accord Miller, 172 Fed.
Cl. at 775.
32 Although the parties were directed to cite reasoned opinions from special masters about
the causal theory proposed, Order, issued July 28, 2022, at 7, Ms. Dotson did not cite Astle or
any other case supporting her theory.
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As explained at length above, the theory with the most robust support---and
the only theory advanced with any meaningful corroboration---is the theory that
the varicella virus from the vaccine infects a person to cause CNS vasculitis.33
Regardless of the strength of this theory as an abstract proposition, the
theory of a direct viral invasion does not help Ms. Dotson show that the varicella
vaccine caused her son’s vasculitis. The Second Order to Show Cause, issued
September 6, 2019, tentatively found that Ms. Dotson could not be found entitled
to compensation based upon the theory of a direct invasion. Strong evidence
against the usefulness of this theory in the context of B.M. came from Dr.
Gershwin, who wrote: “I submit that there is no evidence of infection.” Exhibit 18
at 4. Ms. Dotson agreed. See Pet’r’s Resp. to Second Order to Show Cause, filed
June 12, 2019, at 5 (“Dr. Gershwin points out that the medical records record no
symptoms of infection”). The Secretary, too, stated that B.M. did not have a
varicella infection: B.M.’s “clinical symptoms and findings were not consistent
with a varicella-mediated disease. B.M. did not have symptoms or findings of a
varicella skin disease, as he had no varicella type of rash, which would be a
requirement for a disseminated varicella vaccine-strain disease. B.M.’s
[cerebrospinal fluid] [varicella zoster virus] [polymerase chain reaction] was
negative.” Resp’t’s Rep. at 10-11. The disconnect between what the theory
proposes---a viral infection with varicella---and what actually happened to B.M.---
a lack of preponderant evidence showing a varicella infection---means that Ms.
Dotson cannot prevail on prong two. For examples of appellate authorities ruling
that special masters were not arbitrary in finding that a vaccinee did not respond as
the theory predicted, see Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d
1355, 1364 (Fed. Cir. 2012) (when petitioner’s theory was based upon the vaccine
causing an autonomic neuropathy, “it was plainly necessary” for petitioner to
establish she suffered from an autonomic neuropathy); Miller v. Sec’y of Health &
Hum. Servs., 172 Fed. Cl. 762, 784 (2024) (when asserted a theory involving
immune complexes, petitioner was required to show that she had immune
complexes); Dodd v. Sec’y of Health & Hum. Servs., 114 Fed. Cl. 43, 52-57
(2013) (when petitioner hypothesized a lowering of seizure threshold, special
master could find that the evidence did not support such a lowering); La Londe v.
Sec’y of Health & Hum. Servs., 110 Fed. Cl. 184, 202-05 (2013) (petitioner’s
33 The phrasing “with the most support” should not be interpreted as implying that Ms.
Dotson presented preponderant support for a theory based upon a direct viral infection. Instead,
Ms. Dotson presented negligible support for the other theories, such as molecular mimicry. It is
largely due to the deficiencies on these other theories that the direct viral invasion has risen to
the top.
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theory was premised on a loss of oxygen but evidence did not show an ongoing
loss of oxygen), aff’d, 746 F.3d 1334 (Fed. Cir. 2014); Ricci v. Sec’y of Health &
Hum. Servs., 101 Fed. Cl. 385, 391 (2011) (petitioner’s theory predicted
inflammation but no evidence showed child-vaccinee suffered inflammation); see
also Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1362-63 (Fed.
Cir. 2019) (when petitioner’s claim is premised upon a child-vaccinee having a
brainstem abnormality, petitioner must present proof that child-vaccinee had such
abnormality).
The foregoing presupposes that B.M. suffered from vasculitis, which is the
condition proposed by Ms. Dotson and her experts. However, the Secretary
contends the more fitting diagnoses is an encephalitis caused by an infection with a
coronavirus. Resolving this challenging question is unnecessary because even
assuming that Ms. Dotson’s suggested diagnosis were established preponderantly,
the remainder of Ms. Dotson’s case lacks coherence.
C. Althen Prong Three
The timing prong actually contains two parts. A petitioner must show the
“timeframe for which it is medically acceptable to infer causation” and the onset of
the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101
Fed. Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105
Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013). Here,
the parties dispute the “medically acceptable” time.
The parties do not dispute the onset of B.M.’s disease. They agree that
B.M.’s illness started with a fever on December 1, 2014, which is 21 days after the
vaccination. See Resp’t’s Br. at 50 n.13. This agreement about onset leaves the
question about the appropriate interval.
As with prong two, any analysis of the first part of Althen prong three
requires an acceptance of a theory under prong one. Langland., 109 Fed. Cl. at
443. The theory is linked to the expected temporal interval because different
theories might take different amounts of time. For example, a theory driven by
cytokines is likely to take no more than a few days because cytokines develop and
fade quickly after a vaccination. See Gram v. Sec’y of Health & Hum. Servs., No.
15-515V, 2022 WL 17687972, at *31, *51 (Fed. Cl. Spec. Mstr. Nov. 16, 2022)
(finding more than 15 days too long for a theory that the MMR vaccine caused
afebrile seizures).
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Ms. Dotson’s best theory, again, is a theory that the virus from the varicella
vaccine infected B.M. and caused him to suffer vasculitis. If one were to set aside
the dispositive fact that B.M. was not found to be infected with the varicella virus,
then the direct viral invasion theory could work for Ms. Dotson with respect to
prong three. A varicella infection preceded an ischemic stroke by three weeks in
one report. Exhibit 33 (Nagel & Gilden) at 4. This evidence appears to be
sufficient to find that Ms. Dotson might have prevailed upon Althen prong three.
A more detailed assessment is not required because Ms. Dotson’s claim
falters on Althen prong two. Even if the timing were appropriate, she would not
necessarily be entitled to compensation. Grant v. Sec’y of Health & Hum. Servs.,
956 F.2d 1144, 1148 (Fed. Cir. 1992) (“Temporal association is not sufficient,
however, to establish causation in fact.”).
D. Elements of Respondent’s Case
The analysis began with an assumption that Ms. Dotson had presented
preponderant proof that B.M. suffered from vasculitis. This assumption was made
because from one perspective, the question of diagnosis does not determine the
outcome of Ms. Dotson’s claim. As the analysis shows, Ms. Dotson did not
present a theory (or theories) to explain how a varicella vaccine can cause CNS
vasculitis very well. The only potentially viable theory is that the attenuated but
live virus infected B.M. But, this theory does not match what actually happened to
B.M. because he was not shown to have suffered a varicella infection. For these
reasons, Ms. Dotson did not meet her burden of proof and the Secretary is not
obligated to present an alternative cause. See LaLonde v. Sec’y of Health & Hum.
Servs., 746 F.3d 1334, 1340 (Fed. Cir. 2014).
It bears repeating that one of the Secretary’s primary arguments is that B.M.
suffered from an encephalitis due to an infection with the coronavirus. See
Resp’t’s Br. at 26-36. Resolving the dispute over diagnosis is not required for this
opinion but a finding in Ms. Dotson’s favor would be required to award her
compensation.
V. Conclusion
Regardless of the label put on B.M.’s condition, the medical records show
that his December 2014 illness has caused him a tremendous amount of trouble.
Ms. Dotson and B.M. are entitled to sympathy for their suffering. However,
special masters are required to resolve cases based upon evidence, not emotion. In
this case, the evidence does not preponderate in Ms. Dotson’s favor.
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The Clerk's Office is instructed to enter judgment in accord with this
decision unless a motion for review is filed. Information about filing a motion for
review, including the deadline, can be found in the Vaccine Rules, which are
available on the website for the Court of Federal Claims.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
48

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_17-vv-00637-2
Date issued/filed: 2025-07-25
Pages: 20
Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) re: 202 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge Robin M. Meriweather. (bad) Service on parties made.
--------------------------------------------------------------------------------
Case 1:17-vv-00637-RMM Document 204 Filed 07/25/25 Page 1 of 20
In the United States Court of Federal Claims
DANIELLE DOTSON, as parent and natural
guardian of B.M., a minor,
Petitioner, No. 17-vv-0637
(Filed Under Seal: July 10, 2025
v. Reissued for Publication: July 25, 2025)
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent.
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for Petitioner.
Naseem Kourosh, Torts Branch, Civil Division, United States Department of Justice,
Washington, D.C., for Defendant. With her on the briefs were Yaakov M. Roth, Acting
Assistant Attorney General, C. Salvatore D’Alessio, Director, Heather L Pearlman, Deputy
Director, and Voris E. Johnson, Jr., Assistant Director.
OPINION AND ORDER
Meriweather, Judge.
Petitioner, Danielle Dotson, as parent and guardian of her minor son, B.M., seeks review
of Special Master Moran’s Entitlement Decision (“Decision”), denying her entitlement to
compensation pursuant to the National Childhood Vaccine Injury Act of 1986. See 42 U.S.C.
§§ 300aa-1 to -34 (“Vaccine Act” or “Act”); see generally Pet’r’s Mot. for Review, ECF No. 197
(“Mot.”). Specifically, Ms. Dotson argues that the Special Master’s fact finding concerning her
burden of proof under prong one of the causation-in-fact test set forth in Althen v. Secretary of
Health & Human Services, 418 F.3d 1274, 1278 (Fed. Cir. 2005), was arbitrary and capricious
because the Special Master “erred . . . by not considering the [record] evidence . . . as a whole[]
and [by] improperly imposing a heightened burden of proof of scientific certainty.” Mot. at 1 ¶¶
1–3. On March 11, 2025, Respondent, Secretary of Health and Human Services (the
“Secretary”) filed his Memorandum in Response to Petitioner’s Motion for Review
(“Response”), wherein he argues that the Special Master properly denied entitlement in this case
because Ms. Dotson failed to “establish by preponderant evidence that the vaccination [] B.M.
received” was the factual cause of his later-developed neurological condition. Resp’t’s Mem. in
 Pursuant to Vaccine Rule 18(b), this Opinion was initially filed on July 10, 2025, and
the parties were afforded fourteen days to propose redactions. The parties did not propose any
redactions and, accordingly, this Opinion is reissued in its original form for publication.

Case 1:17-vv-00637-RMM Document 204 Filed 07/25/25 Page 2 of 20
Resp. to Pet’r’s Mot. for Review at 2, ECF No. 199 (“Resp.”). Having considered the parties’
oral arguments, reviewed the relevant filings,1 the law, and for the reasons explained herein, the
Court hereby DENIES Ms. Dotson’s Motion for Review and SUSTAINS the Special Master’s
decision.
BACKGROUND
A. Factual Background
The Special Master set forth the factual and procedural background of this case, including
summarizing B.M.’s medical records for the relevant time period, and both parties’ expert
reports, in his Decision. See generally Decision. For purposes of the pending motion, the Court
will briefly summarize the relevant facts incorporated in that Decision, which are not in dispute.
B.M. was born on August 16, 2013, and on November 7, 2014, he received a ProQuad
vaccine, which is a combined vaccination that “contains attenuated, but live, measles, mumps,
rubella, and varicella2 viruses.” Id. at 2 n.2. On December 2, 2014, B.M. returned to his
pediatrician, presenting with an intermittent fever that started the day before. Id. at 2. That
pediatrician diagnosed B.M. as suffering from fever, seizures, and an ear infection. Id. at 3.
Concerned by the seizures, B.M.’s pediatrician sent B.M. to the emergency room at Norton’s
Children’s Hospital in Louisville, Kentucky. Id.
By the time he arrived at the emergency department, B.M. was actively seizing, and was
quickly transferred to the pediatric intensive care unit. See id. B.M. remained in the hospital for
approximately two weeks, during which time he underwent significant testing—including a brain
CT, a spinal tap, a respiratory pathogen panel, blood work, a brain MRI, a CT angiogram, an
echocardiogram, an MR angiogram, a von Willebrand related antigen panel,3 a second brain
MRI, and flow cytometry—and received varying treatments in an attempt to determine the cause,
and reduce the severity of, his worsening neurological symptoms. Id. at 3–14.
Despite that extensive testing, B.M.’s treating physicians could not identify a clear
1 The following filings are relevant to this Order: Pet. for Compensation, ECF No. 1
(“Pet.”); Am. Pet. for Compensation, ECF No. 64 (“Am. Pet.”); Decision Den. Entitlement, ECF
No. 194 (“Decision”); Mot., ECF No. 197; Resp., ECF No. 199. Throughout, page citations to
documents in the record refer to the document’s original pagination, unless the page is
designated with an asterisk (e.g., *1), in which case the reference is to the pagination assigned by
PACER/ECF.
2 Varicella, colloquially referred to as the chickenpox, is a viral disease commonly
associated with itchy, fluid-filled blisters. Sandeep Kumar & Haitham M. Saleh, Varicella-
Zoster Virus (Chickenpox), NIH (Apr. 27, 2025),
https://www.ncbi.nlm.nih.gov/books/NBK448191/.
3 Von Willebrand factor is a “glycoprotein” that assists with clotting. See Decision at 7.
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explanation for his symptoms and “drew different conclusions.” See id. at 3–15, 11. Ultimately,
B.M.’s physicians posited that there were “multiple possible etiologies,” id. at 12, which could
explain his symptoms, and made their “[b]est estimate[s]” as to B.M.’s diagnosis, id. at 14,
including considering vasculitis4 and coronavirus OC-43,5 which B.M. tested positive for, see id.
at 4, among other potential causal diagnoses. And although B.M.’s physicians considered the
possibility that the varicella component of his earlier vaccination could have contributed to
B.M.’s symptoms, ultimately, all tests for the presence of the varicella virus were negative. See
id. at 9, 45 (noting that Dr. Gershwin agreed “there is no evidence of infection”); Mot. at 39
(“Neither party to this case has proposed that B.M. got infected with chickenpox.”).
On December 15, 2014, B.M. was discharged from Norton’s Children Hospital to a
rehabilitation hospital. See Decision at 15. On December 19, 2014, B.M. was readmitted to the
hospital due to a high fever. See id. Following his second hospital discharge, B.M. was
readmitted for rehabilitation, where he “received daily physical, occupational, and speech
therapy.” Id. For the remainder of 2015, B.M. continued this therapy and underwent additional
testing. See id. at 15–17. B.M.’s parents reported that he “was making significant gains in
development . . . [h]owever, he [still] could not walk independently,” and his physicians posited
that B.M. would likely “have long-term motor deficits” as a result of his ordeal. Id. at 16–17.
B. Procedural Background
On May 15, 2017, Ms. Dotson filed her Petition for Compensation, wherein she alleged
that various vaccines caused B.M. to suffer acute disseminated encephalomyelitis (“ADEM”),6
which she supported by subsequently filing B.M.’s medical records and various affidavits. See
id. at 17 (citing Pet.). The Secretary “challenged Ms. Dotson’s claim that B.M. suffered from
ADEM and argued that, even if B.M. did suffer from ADEM,” the record evidence was
insufficient to support a finding that any of the vaccines B.M. received was the factual cause of
B.M.’s alleged ADEM diagnosis because “Ms. Dotson did not present expert opinion linking the
vaccination to the alleged condition.” Id. (citing Resp’t’s Rep., ECF No. 20). Accordingly, the
Special Master issued instructions for expert reports, but Ms. Dotson failed to timely submit her
4 Vasculitis involves inflammation of the blood vessels, which can cause organ and tissue
damage. See Vasculitis, Mayo Clinic (Feb. 5, 2025), https://www.mayoclinic.org/diseases-
conditions/vasculitis/symptoms-causes/syc-20363435. There are multiple types of vasculitis,
most of which are uncommon. See id.
5 “OC-43” is one variant of the common human coronavirus, which usually causes mild
to moderate upper-respiratory-tract illnesses. See Common Human Coronavirus, CDC,
https://www.cdc.gov/coronavirus/downloads/Common-HCoV-fact-sheet-508.pdf (last visited
July 9, 2025). “This strain of the coronavirus differs from the strain that caused the pandemic.”
Decision at 4.
6 ADEM is a rare neurological condition causing central nervous system inflammation.
See Acute Disseminated Encephalomyelitis (ADEM), Cleveland Clinic (May 30, 2023),
https://my.clevelandclinic.org/health/diseases/14266-acute-disseminated-encephalomyelitis-
adem. ADEM can be caused by both viral and bacterial infections. See id.
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expert reports. See id. (citing Order Regarding Expert Reps., ECF No. 22).
Nearly a year later, following repeated extensions, see ECF Nos. 27, 29, 32, 35, 41, Ms.
Dotson still had not filed any expert reports; thus, the Secretary sought dismissal based on the
lack of those reports. See Decision at 18 (citing Mot. to Dismiss, ECF No. 43). Ms. Dotson’s
counsel notified the Special Master that he would file a report from Lawrence Steinman shortly,
and, based upon that representation, the Special Master denied the Secretary’s motion, affording
Ms. Dotson additional time to file Dr. Steinman’s expert report. Id. (setting January 7, 2019 as
the deadline for Ms. Dotson’s expert reports). After another extension, Ms. Dotson finally filed
her expert “report” on April 22, 2019—not from Dr. Steinman as she initially represented—but
from M. Eric Gershwin. Id. (citing Ex. 15, ECF No. 53-1).
1. Dr. Gershwin’s Initial Expert Reports
In Dr. Gershwin’s first “report,” a two-page letter, he did not opine that any vaccination
harmed B.M., nor did he present any conclusions as to a potentially causative medical theory.
See Ex. 15 at 1–2; Decision at 18. Rather, he stated that he “required additional information,” as
described within that two-page letter, to “be in a better position to prepare a report.” Ex. 15 at 1–
2; Decision at 18. The Special Master issued a Show Cause Order, warning Ms. Dotson that her
case may be dismissed for failure to prosecute because although Ms. Dotson “ha[d] been
obligated to file an expert report for a significant time,” she had failed to do so. Order to Show
Cause at 1, ECF No. 54. As the Special Master noted in that Order, Dr. Gershwin’s “report,” “at
its basic level” did not attempt to comply with the instructions for expert reports; did not opine
that any vaccination harmed B.M. in any manner; and Ms. Dotson did not “present any plan by
which she would obtain the information Dr. Gershwin ha[d] requested.” Id. at 2. The Special
Master found that letter was so rudimentary, so conclusory, and so unsupportive of Ms. Dotson’s
case, that he queried whether it had even been “intended for submission to the Court.” Id.
Thereafter, Ms. Dotson filed a six-page report from Dr. Gershwin dated May 14, 2019,
see Ex. 18, ECF No. 55-1, wherein he “opined that a varicella vaccine caused B.M. to suffer
vasculitis,” and stated that he was “concerned about two potential factual errors in the medical
records that will lead to incorrect interpretation of the data and therefore an incorrect diagnosis in
this youngster.” Decision at 18–19 (quoting Ex. 18 at 4–6, ECF No. 55 (discussing two
perceived errors, namely: (1) that B.M. did not have an immune deficiency; and (2) that B.M. did
not suffer from an infection with a coronavirus)).
After the Secretary filed a second motion to dismiss, once again arguing that Ms. Dotson
“failed to meet the requirements for compensation for a causation-in-injury claim” because “Dr.
Gershwin’s reports [were] patently insufficient to meet [her] burden of proof,” Mot. to Dismiss
at 3, ECF No. 56, Ms. Dotson added another report from Dr. Gershwin. See Ex. 40, ECF No. 61.
That supplemental report “is approximately one page. . . . Dr. Gershwin wrote approximately one
sentence on Althen prong one and two sentences on Althen prong two.” Decision at 19 (noting
that the “balance of the report was about Althen prong three”). Although the Special Master
“stretched what Dr. Gershwin had written to understand that Dr. Gershwin may have been
proposing a theory based upon either a varicella infection or hypersensitivity reaction,” id. at 20
(quoting Order to Show Cause, ECF No. 62), the Special Master concluded that neither theory
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supported Ms. Dotson’s case. Id. at 19–20 (citing Order to Show Cause, ECF No. 62). The
Special Master concluded the first causative theory was “problematic” because “although the
varicella vaccine might lead to a varicella infection as a matter of theory, Ms. Dotson could not
prevail upon this theory” because, as Dr. Gershwin himself acknowledged, “there is no evidence
of infection.” Id. at 20 (citing Ex. 18 at 4). The Special Master similarly concluded that Dr.
Gershwin’s hypersensitivity reaction theory was equally “incapable of resulting in . . .
compensation to Ms. Dotson because: (1) ‘Dr. Gershwin ha[d] not cited evidence that B.M.
suffered an allergic reaction’; and (2) ‘the latency between the vaccination and the date of
hospitalization (25 days) appears to exceed the amount of time [] for an allergic reaction to
manifest.’” Id. (quoting Order to Show Cause at 4, ECF No. 62) (cleaned up). “Thus, Ms.
Dotson was given another opportunity to present a comprehensive, complete, and reliable report
from Dr. Gershwin,” and was “directed to have Dr. Gershwin comply with the instructions.” Id.
(cleaned up).
Although “Ms. Dotson attempted to comply,” id., with the Special Master’s second Show
Cause Order by filing another, approximately eight-page report from Dr. Gershwin, see Ex. 47,
ECF No. 63-1, that report “was not a model of clarity.” Decision at 20. Indeed, “Dr. Gershwin
copied much of the material from his previous reports.” Id. (identifying the ways in which
Exhibit 47 is duplicative). The Special Master found this report so conclusory that “discerning
a[ny medical] theory . . . is difficult.” Id. Dr. Gershwin dedicated a scant, four paragraphs to his
“Theory, Althen 1.” See id. The Special Master summarized Dr. Gershwin’s theory in his
Decision as follows—
[As] Dr. Gershwin wrote: “The ‘theory’ is that Varicella antigens, whether from a
live virus or from a live viral Varicella vaccine can cause CNS vasculitis. The
cause and effect relationship between the Varicella antigen and CNS vasculitis is
known and accepted by the medical community.” For the proposition, that the
medical community accepts this relationship Dr. Gershwin cited a series of case
reports as well as one article, Wise. Under the heading, “Althen III,” Dr.
Gershwin wrote another paragraph and within this paragraph, Dr. Gershwin
discussed timing in the context of molecular mimicry.
Id. at 20–21 (internal citations omitted). Following Dr. Gershwin’s latest report, which the
Special Master initially found was at least “adequate,” Ms. Dotson amended her petition to allege
that B.M.’s varicella vaccine caused B.M. to suffer from vasculitis. Id. at 21 (citing Am. Pet.).
2. Dr. Kruer’s Initial Expert Reports
The Secretary responded to Dr. Gershwin’s opinions by presenting an approximately
four-page report from Dr. Kruer, wherein he requested original images of various studies and
opined that: (1) B.M. likely suffered an infection with a primary coronavirus; (2) “a diagnosis of
vasculitis was never confirmed”; and (3) B.M. suffered a primary immunodeficiency. Id. (citing
Ex. C, ECF No. 70-1). After obtaining those requested diagnostic images, Dr. Kruer submitted a
supplemental report, wherein he contended that Dr. Gershwin failed to “proffer[] a theory of
causality,” and that it was “far more likely than not B.M.’s symptoms were due to the
Coronavirus OC43 in the context of his underlying immunodeficiency.” Id. (quoting Ex. P at 3–
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4, ECF No. 77-1).
3. Dr. Wilson’s Initial and Dr. Gershwin’s Supplemental Expert
Reports
Thereafter, Ms. Dotson submitted a seven-page report from David Wilson. See Ex. 54,
ECF No. 90-1; Decision at 22. Based on his review of various imaging studies and a “limited
amount of clinical information,” Dr. Wilson acknowledged that “this [was] a challenging case”
and concluded that “the most likely explanation for B.M.’s condition was a vasculopathy7 which
may have been of infectious or immunogenic origin; however, this vasculopathy was almost
certainly not caused by the cited pathogen OC43.” Decision at 22 (quoting Ex. 54 at 2–4)
(internal citations omitted). In reaching this conclusion, Dr. Wilson suggested a number of
different possible diagnoses that might explain B.M.’s symptomology including: (1) a
vasculopathy; (2) a cerebritis/cerebellitis8 caused by an infectious agent; (3) acute demyelinating
injury either ADEM or acute hemorrhagic encephalomyelitis9 (“AHEM”); or (4) an embolic
stroke. See id.
In conjunction with Dr. Wilson’s report, Ms. Dotson submitted another one-page report
from Dr. Gershwin, wherein he largely “agree[d] with Dr. Wilson’s opinions and maintains his
previously expressed opinions,” which he presented in an abbreviated format, i.e., a bulleted list.
See id. (citing Ex. 76, ECF No. 88).
4. Dr. Zucconi’s Initial and Dr. Kruer’s and Dr. Gershwin’s
Supplemental Expert Reports
On January 6, 2021 the Secretary filed a six-page supplemental report from Dr. Kruer,
wherein he largely “agree[d] with Dr. Wilson’s assessment[] [that] B.M.’s neuroimaging [was]
highly unusual” because that imaging “is not ‘typical’ of anything.” Id. at 22–23 (quoting Ex. X
at 1, ECF No. 95-1) (noting that “Dr. Kruer’s opinions were directed to Dr. Wilson” because Dr.
Kruer concluded that “Dr. Gershwin’s report did not contain any new assertions”). Given B.M.’s
atypical diagnostic imaging, Dr. Kruer posited that “we are very likely [] dealing with either a
rare disease, [] an atypical manifestation of a common disease, or some combination of the two.”
Id. at 23 (quoting Ex. X at 1). After accounting for this caveat, Dr. Kruer reiterated his earlier
7 Vasculopathy is a general term that refers to any disease or abnormality affecting the
blood vessels. See Vascular Disease (Vasculopathy), Cleveland Clinic (March 22, 2022),
https://my.clevelandclinic.org/health/diseases/17604-vascular-disease.
8 Cerebritis is a type of encephalitis involving inflammation of the cerebrum, the largest
part of the brain. See Encephalitis, Mayo Clinic (May 16, 2024),
https://www.mayoclinic.org/diseases-conditions/encephalitis/symptoms-causes/syc-20356136.
Cerebellitis is another type of encephalitis involving inflammation of the cerebellum, the part of
the brain largely responsible for controlling muscle movement. See id.
9 AHEM is a rare, central nervous system disease characterized by rapid and progressive
inflammation of the brain’s white matter. See Decision at 21 (citing Ex. 54 at 6).
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opinion that “the most likely diagnosis” is “an atypical coronavirus OC43 encephalitis in the
context of an underlying immunodeficiency,” the bases for which he then explained in greater
detail in the remainder of his report. Id. (citing Ex. X at 1–5). Within that report, Dr. Kruer also
opined that Dr. Gershwin’s and Dr. Wilson’s reports were insufficient to show that the varicella
vaccine caused B.M. to suffer vasculitis as opposed to a coronavirus infection. Id. (citing Ex. X
at 5–6).
Ms. Dotson submitted another two-page report from Dr. Gershwin, wherein Dr.
Gershwin “agreed B.M.’s symptomologies are unusual” but ultimately maintained that such
symptomologies “are consistent with a [] vasculopathy.” Id. (citing Ex. 77 at 2, ECF No. 99-1).
On May 21, 2021, the Secretary filed a two-page report from Dr. Zucconi, which
addressed why a varicella infection was unlikely and why the imaging supports acute viral
encephalitis, as well as an additional report from Dr. Kruer, which challenged Dr. Gershwin’s
conclusion that a diagnosis of vasculopathy was most likely. Id. at 23 (citing Ex. Y, ECF No.
106-1; Ex. Z, ECF No. 107-1).
5. Dr. Shafrir and Additional Expert Testimony
Given the Special Master’s “interest in allowing Ms. Dotson to present her evidence” he
“permitted [her] to add another expert”; thus, on December 20, 2021, Ms. Dotson submitted an
approximately 50-page report from Dr. Shafrir. Id. at 24. As the Special Master noted, the bulk
of this report, approximately 41 pages, merely summarized B.M.’s medical records through
2016. See id. (citing Ex. 84, ECF No. 124-1). In the remainder of that report, Dr. Shafrir opined
that the three most likely potential causative diagnoses were ADEM, encephalitis, and vasculitis,
and concluded that, of these three possible diagnoses, vasculitis was the most likely. See id.
(citing Ex. 84 at 43–45). The Special Master found that although Dr. Shafrir generally concurred
with Dr. Gershwin that the varicella vaccine was the most likely cause of the vasculitis, “Dr.
Shafrir’s opinion as to a potential causal connection between the varicella vaccine and the
vasculitis was not particularly robust.” Id. (citing Ex. 84 at 44–45) (noting that “Dr. Shafrir
declined to address immunological parts of Dr. Kruer’s second report” and “[l]ikewise . . . did
not discuss the radiology [] addressed by Dr. Wilson and Dr. Zucconi”).
The Secretary responded by filing a pair of supplemental reports from Dr. Zucconi and
Dr. Kruer. See id. (citing Ex. AA, ECF No. 131-1; Ex. BB, ECF No. 132-1). Unsurprisingly,
given Dr. Shafrir’s failure to comment on B.M.’s radiology results, Dr. Zucconi maintained his
initial conclusion that B.M. had acute viral encephalitis caused by a coronavirus infection. See
id. And Dr. Kruer’s six-page report responded to Dr. Shafrir “nearly paragraph-by-paragraph.”
Id. (citing Ex. BB).
In a May 4, 2022 status conference, Ms. Dotson represented that there were no remaining
expert opinions to be proffered in this case; accordingly, the Special Master issued a briefing
order. See id. at 25 (citing Order, ECF No. 135). Despite this representation, Ms. Dotson filed
an additional five-page report from Dr. Shafrir just one week after that briefing order was issued,
which the Special Master noted “criticizes Dr. Kruer with language that is potentially
inflammatory.” Id. at 25 n.14 (citing Ex. 99 at 3, ECF No. 138-1). The Secretary objected to Dr.
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Shafrir’s report, but the Special Master overruled that objection, allowing the report to remain in
the record, in part, because “the Secretary would not be prejudiced” and “could respond with
more reports.” Id. at 25.
The Secretary filed one last report from Dr. Kruer in response, wherein Dr. Kruer refutes
Dr. Shafrir’s contentions. See id. at 26 (citing Ex. CC, ECF No. 151-1). The parties proceeded
to briefing the issues, including the threshold dispute concerning the appropriate diagnosis for
B.M., with Ms. Dotson “convinced” that the appropriate diagnosis was vasculitis and the
Secretary alternatively contending that B.M. suffered from encephalitis. Id. at 27 (quoting
Pet’r’s Br. at 1, ECF No. 157).
6. The Special Master’s Decision Denying Entitlement and Ms.
Dotson’s Instant Motion
In his Decision, the Special Master, after first assuming for purposes of his argument that
B.M.’s ultimate diagnosis was vasculitis,10 see id. at 30, concluded that “Ms. Dotson [] failed to
meet all the elements necessary to show that the varicella vaccine was the cause-in-fact of (an
assumed) vasculitis.” Id. In reaching this conclusion, the Special Master took the “unusual step”
of allowing Ms. Dotson multiple opportunities to clarify her causative theory as described above,
see id. at 36, then carefully and comprehensively reviewed all of Ms. Dotson’s submitted expert
reports and literature. See id. at 31–42. The Special Master ultimately found that Ms. Dotson
failed to present any theory causally connecting the vaccine at issue to B.M.’s assumed vasculitis
as required under Althen prong one. See id. at 35 (“Ms. Dotson had one final chance to identify
the theories she was asserting by filing a reply brief. However, she was silent.”). Accordingly,
the Special Master denied entitlement, concluding that Ms. Dotson had not met her Althen prong
one burden of proof because she failed to establish by preponderant evidence that B.M.’s
November 7, 2014 vaccination caused him to develop the assumed vasculitis. See id.
On February 10, 2025, Ms. Dotson filed her Motion for Review, arguing that the Special
Master: (1) acted arbitrarily and capriciously when making fact findings concerning Ms.
Dotson’s Althen prong one proof; (2) erred by not “considering the evidence on the record as a
whole”; and (3) erred by improperly heightening Ms. Dotson’s burden of proof to require
“scientific certainty” rather than preponderance. See Mot. at 2. The Secretary contends that the
Special Master, after conducting a “thorough review of the record” and after “thoughtfully
weigh[ing] [all] the evidence,” “properly denied entitlement” in this case. Resp. at 2. On June
20, 2025, the Court held oral argument on Ms. Dotson’s Motion.
10 The Federal Circuit has held that a special master may, in the unusual case where the
alleged injury is disputed, “first determine which injury was best supported by the evidence in
the record before applying the Althen test.” Decision at 30 (quoting Broekelschen v. Sec’y of
Health & Hum. Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010)). Although the Secretary
“maintains . . . that [the] alleged diagnosis of vasculitis was not preponderantly established,” the
Secretary proceeds to “address[] [Ms. Dotson’s] arguments on appeal based upon the Decision as
issued.” Resp. at 4 n.2. Given that Ms. Dotson does not contend the Special Master’s threshold
determination was in error, the Court proceeds on the assumption that the alleged injury in this
case is vasculitis.
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LEGAL STANDARD
“Under the Vaccine Act, the Court of Federal Claims reviews the decision of a special
master to determine if it is arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1350 (Fed.
Cir. 2008) (citing Althen, 418 F.3d at 1277). In Vaccine Act cases, this Court uses three distinct
standards of review—fact findings are reviewed under the “arbitrary and capricious” standard;
legal conclusions are reviewed de novo under the “not in accordance with the law” standard; and
discretionary rulings under the “abuse of discretion” standard. Munn v. Sec’y of Health & Hum.
Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992) (cleaned up).
The arbitrary and capricious “standard of review [applicable to vaccine cases] is uniquely
deferential for what is essentially a judicial process,” and the Federal Circuit has warned against
“second guess[ing] the Special Master[’]s fact-intensive conclusions,” particularly in those cases
“in which the medical evidence of causation is in dispute.” Hodges v. Sec’y of Health & Hum.
Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). “The law is settled that this Court cannot substitute its
judgment for that of the Special Master merely because it might have reached a different
conclusion.” Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 718 (2009) (cleaned up);
see Broekelschen, 618 F.3d at 1345. Thus, this Court “does 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.” Broekelschen, 618 F.3d at 1349
(cleaned up). “If [a] special master has considered the relevant evidence of record, drawn
plausible inferences[,] and articulated a rational basis for the decision, reversible error will be
extremely difficult to demonstrate.” Hines v. Sec’y of Health & Hum. Servs., 940 F.2d 1518,
1528 (Fed. Cir. 1991). Accordingly, this Court should not find that a special master’s fact
conclusions are arbitrary and capricious unless they are “so implausible that [they] could not be
ascribed to a difference in view.” Id. at 1527 (cleaned up). Indeed, if a special master’s
“conclusion is based on evidence in the record that is not wholly implausible, [this Court is]
compelled to uphold that finding as not being arbitrary or capricious.” Cedillo v. Sec’y of Health
& Hum. Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010); see also Lampe v. Sec’y of Health & Hum.
Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000).
DISCUSSION
The Special Master’s Fact Conclusions Under Althen Prong One Were Rational
and Well-Supported.11
The Vaccine Act, enacted in 1986, created the National Vaccine Injury Compensation
Program, through which claimants can petition to receive compensation for vaccine-related
injuries or death. See generally 42 U.S.C. § 300aa-10(a). Under the Act, there are two ways a
11 This section addresses Ms. Dotson’s arguments that the Special Master’s “fact finding
in relation to [her] Althen prong 1 [sic] proof was arbitrary and capricious.” Mot. at 2.
Accordingly, the Court reviews the Special Master’s findings of fact under that “uniquely
deferential” standard of review. Hodges, 9 F.3d at 961; see also Munn, 970 F.2d at 870 n.10.
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petitioner can establish causation and thus qualify for compensation. First, a petitioner may
establish that the vaccinee, after receiving a designated vaccine, suffered an injury listed on the
Vaccine Injury Table within the requisite time period—commonly called a “Table Injury,” see
42 C.F.R. § 100.3(a)—in which case causation is presumed. See 42 U.S.C. § 300aa-11(c)(1).
Alternatively, if a petitioner claims entitlement for an injury not listed in the Vaccine Injury
Table, i.e., an “Off-Table case,” the petitioner must instead prove that the vaccination was the
cause-in-fact (“actual causation” or “causation in fact”) of the vaccinee’s asserted injury. See id.
§ 300aa-11(c)(1)(C)(ii)(I).
The Federal Circuit has long affirmed that the standard for proving causation in fact
under the Vaccine Act is the same as the standard for proving “legal cause” in the general torts
context. See Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999); de
Bazan, 539 F.3d at 1351. Specifically, the Federal Circuit has “adopt[ed] the Restatement rule
for purposes of determining vaccine injury,” and “[a vaccine] is the ‘legal cause’ of harm if that
[vaccine] is a ‘substantial factor’ in bringing about the harm, and [if] that [] harm would not have
occurred but for the [vaccination].” Shyface, 165 F.3d at 1352 (citing Restatement (Second) of
Torts § 431(a) (Am. L. Inst. 1965)). To establish that a vaccine is a “substantial factor” in
bringing about the alleged harm, the petitioner in an “Off-Table Injury” case such as this one
must satisfy the three-prong test first articulated in Althen and establish—
by preponderant evidence that the vaccination brought about [B.M.’s] injury by
providing: (1) a medical theory causally connecting the vaccination and the
injury; (2) a logical sequence of cause and effect showing that the vaccination was
the reason for the injury; and (3) a showing of a proximate temporal relationship
between vaccination and injury.
Althen, 418 F.3d at 1278; see also Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351,
1355 (Fed. Cir. 2019); Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 (Fed.
Cir. 2010). It is well-settled that a petitioner must prove “each of the three Althen prongs by a
preponderance of the evidence,” Boatmon, 941 F.3d at 1355, and that “failure to establish any
one prong is dispositive.” Exum v. Sec’y of Health & Hum. Servs., 175 Fed. Cl. 681, 702 (2025).
A. The Special Master Carefully Weighed and Considered All Relevant
Evidence to Support His Well-Reasoned Findings.
Ms. Dotson contends that the Special Master rejected her Althen prong one evidence “out
of hand,” without offering any “reasons,” “explanation,” or “foundation.” Mot. at 27–29. The
Court disagrees. The Special Master afforded Ms. Dotson repeated opportunities to support her
claim, “drew generous inferences in [her] favor,” Resp. at 6, exhaustively reviewed Ms. Dotson’s
briefing and the evidence (even in those circumstances, where it was questionable whether he
was required to do so), and rationally supported his findings in support of his determination that
Ms. Dotson failed to meet her burden under Althen prong one. See Althen, 418 F.3d at 1278.
Accordingly, “reversible error will be extremely difficult to demonstrate.” Hines, 940 F.2d at
1528.
First, the Special Master did not reject Dr. Gershwin’s reports “out of hand,” Mot. at 29,
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rather, he undertook a “painstaking review” of those reports, “for anything resembling a coherent
theory,” Resp. at 8, but ultimately concluded that Dr. Gershwin’s “attempts to put forward a
minimally competent medical theory fell well short.” Decision at 31. As noted above, Dr.
Gershwin’s first “report,” a two-page letter, was patently insufficient, as, somewhat
confoundingly, given that this a case seeking compensation for an alleged vaccine injury—he did
not opine that any vaccination harmed B.M. See Ex. 15 at 1–2; Decision at 18. That first report
was so conclusory, and so unsupportive of Ms. Dotson’s case, that the Special Master questioned
whether it had even “be[en] intended for submission.” Order to Show Cause at 2, ECF No. 54.
Dr. Gershwin’s second report was equally “problematic.” Decision at 20. Although the Special
Master, again, afforded Dr. Gershwin leniency, “stretch[ing] what Dr. Gershwin had written” to
understand that Dr. Gershwin was proposing either a varicella infection or a hypersensitivity
reaction theory, the Special Master concluded neither of those theories were viable as presented,
id. at 19–21 (quoting Order to Show Cause, ECF No. 62), in part, because as Dr. Gershwin
himself acknowledges, and Ms. Dotson concedes, “there is no evidence of [varicella] infection”
here. Id. at 20 (citing Ex. 18 at 4).
Similarly, Dr. Gershwin’s third report, “copied much of the material” from his previous
two reports, “was not a model of clarity,” and only included four, conclusory paragraphs under
the heading “Theory, Althen I.” Id. at 20 (citing Ex. 47 at 5–6). In that report, Dr. Gershwin
stated “[t]he ‘theory’ is that Varicella antigens, whether from a live virus or from a live viral
Varicella vaccine can cause CNS vasculitis. The cause and effect relationship between the
Varicella antigen and CNS vasculitis is known and accepted by the medical community.” Ex. 47
at 5–6 (citing, in support of this proposition, a series of case reports, and one article, the Wise
article). Despite these clear deficiencies, again, the Special Master afforded significant leniency,
interpreting this report as proposing a causative theory of “molecular mimicry” under Althen
prong one and finding that third report sufficiently “adequate” for the case to proceed. Decision
at 21. But Dr. Gershwin never explained or further elaborated on this theory beyond this cursory
statement in his third report, that is—the “evidence and arguments regarding molecular mimicry
[were] too general to be persuasive.” Id. at 42 (noting that Dr. Gershwin’s reports “at least
mention the idea” of molecular mimicry and that “[h]is second report includes the phrase . . .
‘molecular mimicry’ in the context of Althen prong three”).
In Orloski, the Federal Circuit concluded that the Special Master did not err by refusing
to consider the petitioner’s primary expert opinion which the Special Master determined was
“too conclusory and underdeveloped to be persuasive.” Orloski v. Sec’y Health & Hum. Servs.,
839 Fed. Appx. 538, 541 (Fed. Cir. 2021). In that case, although the Special Master gave the
petitioner “several opportunities to bolster her case and provide a more detailed expert report,”
those reports the petitioner did submit “did not provide any reasoning for how or why [the
vaccinations] would cause” the alleged injury. Id. at 541–42. Here, as in Orloski, the Special
Master afforded Ms. Dotson multiple opportunities to supplement her reports, and specifically
identified why the reports submitted were deficient. But Dr. Gershwin’s ultimate submissions
never articulated “any reasoning for how or why” the varicella vaccination could cause
vasculitis. Id. The Special Master here was “entitled to require some indicia of reliability to
support” Dr. Gershwin’s conclusory assertions, Moberly, 592 F.3d at 1324, he found none, and
the Court declines to “reweigh th[at] [] evidence.” Broekelschen, 618 F.3d at 1349; see also
Perreira v. Sec’y of Health & Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (“An expert
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opinion is no better than the soundness of the reasons supporting it.”).
And, “[f]or [the] sake of completeness,” the Special Master quoted Ms. Dotson’s12
argument concerning Dr. Gershwin’s molecular mimicry causative theory in full—which he was
able to do easily due to its conclusory nature—remarking that she “did not elaborate” on that
argument, “included [a mere] one sentence from three [of the cited] articles,” and “without any
descriptive information,” cited another eight articles. Decision at 33–34. The Special Master
specifically noted that although Ms. Dotson discussed Althen prong one in her brief, she did so
“in approximately two double-spaced pages,” and simply asserted, without support, that “[t]here
is abundant evidence linking varicella to vasculitis,” and “[t]he literature treats it as a given.” Id.
at 32. Notably, this is the same argument that Ms. Dotson quotes verbatim in her pending
Motion. Compare Decision at 33, with Mot. at 17. The Special Master did not err by
“conclud[ing] that there [was] simply too great an analytical gap between the data and the
opinion proffered.” Cedillo, 617 F.3d at 1339.
The Special Master similarly exhaustingly examined the “primary piece of evidence,” in
this case, the Wise article, which Dr. Gershwin cites in both his first and third reports. Decision
at 36; see also Ex. 18 at 5; Ex. 47 at 5. As described by the Special Master, “[i]n this article,
Robert P. Wise and his colleagues searched Vaccine Adverse Event Reporting System
(“VAERS”) . . . [where] [t]hey found 15 cases of vasculitis . . . [a]mong [those] 15 vasculitis
reports, 3 children . . . appeared to have Kawasaki syndrome, and 10 patients developed Henoch-
Schönlein purpura within 7 weeks of vaccination.” Decision at 36 (citing Ex. 37 at 1272–75,
ECF No. 59-3). The Special Master analyzed the Wise article in conjunction with a different
study cited by the Secretary’s expert, Dr. Kruer, in response to the Wise article, and found both
unpersuasive—“[t]he relative weakness of [Dr. Kruer’s cited] article does not elevate the value
of Wise article.” Id. at 37 (criticizing Dr. Kruer’s cited article because “[upon] review of this
article [he] did not readily identify any places in which the authors assessed whether the varicella
vaccine can cause vasculitis”). The Special Master concluded that the Wise article should be
afforded little weight because “Wise’s methodology of extracting data from the VAERS database
is not reliable.” Id. The Special Master did not err in making that finding. Indeed, this “Court
uniformly has upheld [a] [] Special Master’s concerns about the reliability of VAERS data,”
Analla v. Sec’y of Health & Hum. Servs., 70 Fed. Cl. 552, 558 (2006) (collecting cases), and
found that VAERS data “has extremely limited value to prove causation due to the manner in
which it is collected, the lack of confirmation of the reported information[,] and the lack of any
systematic analysis.” Capizzano v. Sec’y of Health & Hum. Servs., 63 Fed. Cl. 227, 231 (2004)
(vacated on other grounds); see also Manville v. Sec’y of Health & Hum. Servs., 63 Fed. Cl. 482,
494 (2004) (affirming special master’s finding that a “VAERS report can be filed by anyone,
thereby bringing into question the quantity and quality of the information gathered and creating
the possibility of bias”). Accordingly, the Special Master’s determination that the VAERS
evidence should be afforded little to no weight was both proper and reasonable. See Ryman v.
Sec’y of Health & Hum. Servs., 65 Fed. Cl. 35, 43 (2005).
Next, the Special Master, acting “out of an abundance of caution” even reviewed those
12 Ms. Dotson’s argument is taken verbatim from Dr. Gershwin’s June 18, 2019 expert
report. Compare Decision at 33 (quoting Pet’r’s Status Report, ECF No. 180), with Ex. 40 at 1.
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articles Ms. Dotson cited in her briefing “without any explanation of their relevance[,] [which]
could [have] justif[ied] [his] striking th[ose] articles.” Decision at 34 n.23; see also Sheller v.
Sec’y of Health & Hum. Servs., 121 F.4th 1301, 1309 (Fed. Cir. 2024) (concluding that “the
Special Master did not abuse his discretion in striking [certain] medical articles” once he
“assessed the relevance of each medical article and only struck those determined not to be
relevant”). Despite, once again, affording Ms. Dotson this additional leniency, the Special
Master here still concluded that those cited articles did not support Ms. Dotson’s theory of
causation because they were duplicative, “focus[ed] on conditions not at issue in Ms. Dotson’s
case,” and “concern[ed] [] different vaccine[s]” than the vaccine alleged to have caused B.M.’s
vasculitis. Id. (discussing Ex. 71, ECF No. 88-6, and Ex. 73, ECF No. 88-8, which focused on
possible correlations between the varicella vaccine and stroke and ADEM respectively and
explaining that “Ms. Dotson has not persuasively explained why B.M.’s asserted condition [of
vasculitis] is analogous to either” of those two conditions discussed by the proffered evidence)
(also discussing Ex. 35, ECF No. 59-1, “a case report concerning a different vaccine,” i.e., the
herpes zoster vaccine). In other words, some of the materials Ms. Dotson put forth discussed
neither the varicella vaccine nor vasculitis at all. See H.L. v. Sec’y of Health & Hum. Servs., 715
Fed. App’x 990, 996 (Fed. Cir. 2017) (finding no error in a special master’s determination that
certain articles were not persuasive when those “articles discuss circumstances that are not
directly analogous to [the present] case”). The Special Master further found that Exhibit 35, the
Puram case report, was unreliable because it “provide[s] little, if any, information helpful to
determining causation [as] [it] present[s] only a temporal sequence of events in which the
vaccination preceded an adverse health event.” Decision at 34–35 n.23; see also K.O. v. Sec’y of
Health & Hum. Servs., No. 13-vv-0472, 2016 WL 7634491, at *11 (Fed. Cl. Spec. Mstr. July 7,
2016) (“The only Federal Circuit case to discuss the value of case reports in the Vaccine
Program found no error in a special master’s giving the case reports little weight.”). The Special
Master carefully weighed this evidence (even though he conceivably was not required to do so)
to reach plausible conclusions. The Court declines to “second guess” the Special Master’s “fact-
intensive” conclusions, which were well within his purview. Hodges, 9 F.3d at 961.
The Special Master proceeded to comprehensively review each of the remaining articles
proffered by Ms. Dotson, and relied upon by her experts, in turn, including: the Nagel and Gilden
article (Ex. 33, ECF No. 58-6); the Strauss article (Ex. 46, ECF No. 61-7); the Gilden article (Ex.
51, ECF No. 63-5); the Nagel and Bubank article (Ex. 34, ECF No. 58-7; Ex. 57, ECF No. 87-2);
the Rojas article (Ex. 45, ECF No. 61-6); the Guillevin article (Ex. 41, ECF No. 61-2); the
Celluci and Benesler article (Ex. 98, ECF No. 125-5); and the Twilt and Beneseler article (Ex.
87, ECF No. 124-4). See Decision 38–41. Although Ms. Dotson wrote “at least one sentence in
the context of Althen prong one,” about these articles, the Special Master devotes three, single-
spaced pages to his fulsome analysis. Id. at 41. The Special Master afforded these remaining
articles little weight for varying reasons, including that some of those articles, like those articles
discussed above, do not discuss the varicella vaccine or vasculitis. See id. at 40. For example,
he observed that the “Rojas article has limited usefulness in providing a theory to explain how
[the] varicella vaccine can cause vasculitis,” given that the authors “discussed how infections
may induce autoimmune diseases through molecular mimicry[,] [t]hey detail evidence in
approximately a dozen diseases, but none are vasculitis.” Id. He further noted that “Guillevin . .
. did not discuss varicella as an inciting agent.” Id. at 41. Ms. Dotson takes issue with the
Special Master’s approach, contending that he improperly “picked off each piece of [] evidence
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individually.”13 Mot. at 31. But this Court cannot imagine another way for the Special Master to
have evaluated Ms. Dotson’s evidence other than to look at each article on its own merits.
Rather, as the Secretary posits—“it would be error to fail to review the articles individually and
to instead only consider the literature as an undifferentiated mass” because a special master must
evaluate all the evidence in the record. Resp. at 14; see also Rule 8(b)(1), Vaccine Rules of the
Office of Special Masters (requiring that the Special Master “must consider all relevant and
reliable evidence”); Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 541 (2011)
(“[C]onsistent with the duties imposed by the Vaccine Act, the task of a Special Master is to
consider [all] the relevant evidence in the record.” (internal citations omitted)).
Ms. Dotson’s alternative argument14 that the Special Master failed to review the evidence
in the “record as a whole,” is similarly unpersuasive.15 Mot. at 29, 31–33. That argument is
undermined by Ms. Dotson’s contention that the Special Master diligently “picked off,” id. at 31,
each piece of evidence one by one—if the Special Master reviewed each and every piece of
record evidence, how could he have also failed to review the record in its entirety? There is
simply no indication that the Special Master improperly excluded evidence or failed to consider
Ms. Dotson’s proffered evidence either individually or collectively. Rather, as identified
throughout this Opinion, the Special Master’s review was exhaustive, he acted permissively in
affording Ms. Dotson additional opportunities to present her case, see Decision at 35, assumed
certain arguments on Ms. Dotson’s behalf, see id. at 43, and evaluated evidence that potentially
could have been stricken, see id. at 34 n.23. There is no basis to disturb the Special Master’s
findings of fact on those grounds.
Finally, Ms. Dotson asserts that the Special Master erred by “ignor[ing]” that B.M.’s
treating physicians “included the varicella vaccine in B.M.’s differential diagnosis.” Mot. at 29.
But the Special Master did not ignore B.M.’s medical records—he cited them explicitly
throughout his Decision. See Decision at 8, 11–14. While the Special Master took great care to
relate all B.M.’s relevant medical history and contemporaneous treating physician notes, the
Court notes that perhaps he could have included a more detailed analysis of those records within
his Decision. Regardless of whether this Court may disagree with the weight afforded to that
evidence, the Special Master was “not required to cite to [nor discuss] every piece of evidence so
13 To the extent that Ms. Dotson is arguing that the totality of these articles should have
persuaded the Special Master, despite each of the articles’ individual deficiencies, the Court
agrees with the Secretary that this argument is illogical. See Resp. at 14. “[T]he sum of many
zeros is still zero.” Id.
14 It is unclear whether Ms. Dotson, in making this argument, is asserting that the Special
Master failed to abide by the Vaccine Act; whether she is asserting the Special Master failed to
review the record evidence cumulatively, and therefore assigned that evidence inappropriate
weight; or whether she is asserting that the Special Master improperly excluded certain evidence.
The Court reviews these arguments de novo, under the arbitrary and capricious standard, and
under the abuse of discretion standard respectively. See Munn, 970 F.2d at 870 n.10. Under any
standard of review, Ms. Dotson’s argument is unavailing.
15 See supra note 11 and accompanying text.
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long as [he] conducts a detailed review of the testimony, medical records, and medical
literature.” Cozart v. Sec’y of Health & Hum. Servs., 126 Fed. Cl. 488, 495 (2016); see also
Simanski v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is
not required to discuss every piece of evidence or testimony in his or her decision.” (collecting
cases)). In fact, as the Federal Circuit has affirmed, this Court presumes that the Special Master
reviewed all the evidence presented absent an explicit expression to the contrary. Hazlehurst v.
Sec’y of Health & Hum. Servs., 604 F.3d 1343, 1352 (Fed. Cir. 2010) (“[E]ven if the Special
Master had made no explicit reference to the [referenced] evidence . . . we would presume that
she considered that evidence.”).
Ultimately, the Special Master, after first generously assuming that Ms. Dotson also
advanced a direct viral invasion theory that was only alluded to in one her articles, but never
directly advanced by her experts, concluded that all of the “theories [presented] lack[ed]
sufficient development” because “one sentence or two sentences [cannot] establish the soundness
of any of them.” Decision at 43–44 (assuming that Ms. Dotson “intended to advance ‘viral
infection’ as a theory to explain how the varicella vaccine can cause vasculitis,” “if only for the
sake of advancing the analysis”). The Special Master gave Ms. Dotson and her experts every
possible opportunity to make their case but found that the evidence presented fell far short of
meeting Ms. Dotson’s burden. Ms. Dotson’s own attempt to show that the Special Master failed
to consider all the evidence, by including block quotations of that allegedly un-reviewed
evidence in her Motion, again only underscores that the Special Master committed no error here
because he, in fact, considered each of those same pieces of evidence. Compare Mot. at 18–23
(citing Ex. 33 (Nagel); Ex. 34, ECF No. 58-7 (Nagel); Ex. 35, ECF No. 59-1 (Puram); Ex. 36,
ECF No. 59-2 (Twilt); Ex. 37 (Wise); Ex. 41 (Guillevin); Ex. 45 (Rojas); Ex. 51 (Gilden); Ex. 87
(Twilt); Ex. 98 (Cellucci)), with Decision at 38–39 (discussing Ex. 33 (Nagel)), 39–40
(discussing Ex. 34 (Nagel)), 19 n.10 (discussing Ex. 36 (Twilt)), 34 n.23 (discussing Ex. 35
(Puram)), 36–37 (discussing Ex. 37 (Wise)), 40–41 (discussing Ex. 41 (Guillevin) and Ex. 45
(Rojas)), 39 (discussing Ex. 51 (Gilden)), 41 (discussing Ex. 87 (Twilt) and Ex. 98 (Cellucci)).
Indeed, after a thorough review of the record evidence and the Special Master’s decision below,
this Court has been unable to identify a single piece of relevant evidence that the Special Master
failed to carefully consider, analyze, and weigh. See Hines, 940 F.2d at 1528.
In sum, the Special Master scoured the record for any evidence that might support Ms.
Dotson’s claim, while affording Ms. Dotson multiple opportunities to correct the deficiencies he
identified, but “simply found the evidence lacking.” Resp. at 11. He comprehensively
considered and weighed both the expert reports and literature, alongside Ms. Dotson’s briefing,
drew plausible inferences, and rationally concluded that Ms. Dotson’s theories were too
unsubstantiated, vague, and undeveloped to carry her burden under Althen prong one. See Hines,
940 F.2d at 1528. Accordingly, this Court is “compelled to uphold that finding as not being
arbitrary or capricious.” Cedillo, 617 F.3d at 1338.
The Special Master’s Conclusion that Ms. Dotson Failed to Satisfy her Burden of
Proof Under Althen Prong One Was in Accordance with the Law.
A. The Special Master Did Not Impermissibly Raise Ms. Dotson’s Burden of
Proof.
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Ms. Dotson contends that the Special Master improperly heightened her Althen one prong
burden of proof; arguing that the Special Master impermissibly required her to prove causation
by “produc[ing] evidence . . . of scientific certainty” instead of mere preponderance.16 Mot. at
33. Ms. Dotson is correct that “[t]he standard of proof required by the Act is simple
preponderance of evidence . . . not scientific certainty.” Bunting v. Sec’y of Health & Hum.
Servs., 931 F.2d 867, 873 (Fed. Cir. 1991) (emphasis added) (“[I]t is not [petitioner’s] burden to
disprove every possible ground of causation . . . nor must the findings of the [Special Master]
meet the standards of the laboratorian.” (internal citations omitted)); Althen, 418 F.3d at 1280.
In other words, “the statutory standard of preponderance of the evidence requires a petitioner to
demonstrate that the vaccine more likely than not caused the condition alleged.” LaLonde v.
Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1338–39 (Fed. Cir. 2014) (“[T]he burden of
showing something by a preponderance of the evidence . . . simply requires the trier of fact to
believe that the existence of a fact is more probable than its nonexistence.”).
A special master improperly heightens a petitioner’s burden by requiring “objective
confirmation that the vaccine administered is potentially [causative] [of] the injury alleged,”
Althen, 418 F.3d at 1279, either through “identification and proof of specific biological
mechanisms,” or presentation of “epidemiologic studies, rechallenge, the presence of
pathological markers or genetic disposition, or general acceptance in the scientific or medical
communities.” Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1325 (Fed. Cir.
2006) (quoting Althen, 418 F.3d at 1280; Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d
543, 549 (Fed. Cir. 1994)). “[S]uch an approach is inconsistent with allowing the use of
circumstantial evidence envisioned by the preponderance standard.” Id.
And as Althen clarifies, although “scientific certainty” is not the applicable standard of
proof, a petitioner’s “theory of causation must [still] be supported by a reputable medical or
scientific explanation.” Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379–80 (Fed.
Cir. 2009); see also Broekelschen, 618 F.3d at 1345 (“[A] petitioner must provide a reputable
medical or scientific explanation that pertains specifically to the [vaccinee’s] case, although
th[at] explanation need only be ‘legally probable.’”); Knudsen, 35 F.3d at 548 (requiring a
“sound and reliable medical or scientific explanation”). Thus, neither a “special master [n]or
[this] [C]ourt may [] make . . . a finding [of causation] based on the claims of a petitioner alone,
unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa-13(a)(1).
Accordingly, the Federal Circuit has “consistently rejected theories that the vaccine only ‘likely
caused’ the [alleged] injury and [has] reiterated that a ‘plausible’ or ‘possible’ causal theory does
not satisfy the [preponderance] standard.” Boatmon, 941 F.3d at 1360 (collecting cases); see
also LaLonde, 746 F.3d at 1339 (“[W]e have made clear that simply identifying a ‘plausible’
theory of causation is insufficient for a petitioner to meet [their] burden of proof.”); Moberly,
592 F.3d at 1322 (noting that the “traditional” standard is “more likely than not” and that “a
[mere] plausible or possible causal link between the vaccine and the injury, [] is not the statutory
16 Ms. Dotson argues that the Special Master erred by improperly heightening her burden
of proof, a legal argument. Accordingly, the Court reviews the Special Master’s conclusion as to
the proper evidentiary burden de novo, but reviews those factual conclusions reached in
assessing whether Ms. Dotson had met the applicable burden of proof under the arbitrary and
capricious standard. See Munn, 970 F.2d at 870 n.10.
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standard”).
Here, the Special Master did not impermissibly heighten Ms. Dotson’s burden of proof.
Rather, the Special Master properly held Ms. Dotson to a preponderance standard, and simply
found the evidence she presented insufficient to preponderantly establish “a medical theory
causally connecting [the ProQuad] vaccination and [B.M.’s] injury.” Althen, 418 F.3d at 1278.
Indeed, the Special Master correctly identified that Ms. Dotson was “required to establish her
case by a preponderance of the evidence” and took care to note that “[d]istinguishing between
preponderant evidence and medical certainty is important because a special master should not
impose an evidentiary burden that is too high.” Decision at 29 (quoting Andreu, 569 F.3d at
1379–80). The Special Master also correctly stated, in accordance with controlling Federal
Circuit precedent, that “[p]resenting a sound and reliable [medical] theory is essential to Ms.
Dotson’s case” under Althen prong one. Id. at 35; see also Andreu, 569 F.3d at 1379;
Broekelschen, 618 F.3d at 1345; Knudsen, 35 F.3d at 548 (requiring a “sound and reliable
medical or scientific explanation”). “The Decision correctly articulated that standard here.”
Exum, 175 Fed. Cl. at 704. In fact, “the Federal Circuit recently affirmed a different decision of
the Chief Special Master in which he articulated the standard in nearly the same way.” Id.
(citing Kalajdzic v. Sec’y of Health & Hum. Servs., No. 23-cv-1321, 2024 WL 3064398, at *2
(Fed. Cir. June 20, 2024)).
And although the Special Master repeatedly reminded Ms. Dotson of her obligation to
present a viable causative theory, affording her multiple, additional opportunities to present such
a theory, ultimately the “evidence Ms. Dotson [] advanced . . . f[ell] short of meet[ing] her
burden.” Decision at 30, 36 (“After multiple rounds of expert reports and rounds of briefing,
whether Ms. Dotson has disclosed any theory is debatable. Ms. Dotson was notified repeatedly
that the presentation of any theory was not adequate. She did largely not cure this deficiency.”).
In fact, even though “Ms. Dotson had one final chance to identify the theories she was asserting
by filing a reply brief,” she failed to do so. Id. at 35.
Despite Ms. Dotson’s continued failure to put forth evidence sufficient to support any
theory, the Special Master still thoughtfully, carefully, and deliberately reviewed all the evidence
that Ms. Dotson did put forth, as discussed in more detail, supra, ultimately concluding that none
of that evidence “carr[ied] Ms. Dotson’s burden to demonstrate that the varicella vaccine can
cause vasculitis.” Id. at 31–42. Given the Special Master’s careful consideration of the relevant
record evidence, and the plausible inferences drawn therefrom, this Court declines to “reweigh
the factual evidence” and declines to “[re]assess whether the Special Master correctly evaluated
th[at] evidence” to support his conclusion that Ms. Dotson failed to put forth any viable causative
theory. Munn, 970 F.2d at 871.
Contrary to Ms. Dotson’s argument, the Special Master could not have reasonably
determined that Ms. Dotson preponderantly put forth a causative medical theory in this case
because neither the Special Master nor this Court may “make . . . a finding [of causation] based
on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.”
42 U.S.C. § 300aa-13(a)(1). That is, once the Special Master rationally concluded that all of Ms.
Dotson’s potential causative theories “were presented in such an abbreviated form that they are
not sound and reliable,” he was obligated to find that she failed carry her burden under Althen
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prong one. Decision at 42–43 (“[Ms. Dotson’s] theories lack sufficient development. One
sentence or two sentences do not establish the soundness of any of them.”). It would have been
error for the Special Master to find that Ms. Dotson had met her burden—after finding all the
proffered evidence too vague, irrelevant, and implausible to support any causative theory—
because such a holding would have been premised on nothing other than Ms. Dotson’s assertions
alone. See id. at 45 n.33 (“Ms. Dotson presented negligible support for [her] theories.”). Indeed,
the Federal Circuit has consistently affirmed that mere plausibility is insufficient to meet the
preponderance of evidence standard. See, e.g., Boatmon, 941 F.3d at 1360; W.C. v. Sec’y of
Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (“[P]etitioner must do more than
demonstrate a ‘plausible’ or ‘possible’ causal link between the vaccination and the injury.”). But
see Mot. at 15–17, 26, 29 (referencing a “plausible” medical theory). Accordingly, any such
holding that Ms. Dotson’s causative theory was sufficient on this record would have improperly
lessened Ms. Dotson’s burden of proof under controlling precedent. See Boatmon, 941 F.3d at
1360 (collecting cases); LaLonde, 746 F.3d at 1339 (“[S]imply identifying a ‘plausible’ theory of
causation is insufficient for a petitioner to meet [their] burden of proof.”).
Ms. Dotson’s remaining arguments on this point fare no better.17 Specifically, although
Ms. Dotson argues that the Special Master improperly heightened her burden by requiring her to
produce epidemiological studies to support her claim, see Mot. at 34, the record explicitly
forecloses this argument. While it is true that the Special Master noted that “an affirmative
epidemiological study could have helped Ms. Dotson establish that the varicella vaccine can
cause vasculitis,” he did not in fact require Ms. Dotson to put forth such a study. Decision at 38.
Instead, he clarified—despite Ms. Dotson’s insistence that the Wise article was epidemiological,
he did not believe the Wise paper was an epidemiological study as it lacks the traditional
characteristics of those studies—that “the lack of an epidemiological study does not doom the
claim because a petitioner is not required to present an epidemiologic study.” Id. The Special
Master further noted that: “the Wise study is not persuasive evidence for th[e] proposition” that
the varicella vaccine can cause vasculitis—not because the Wise study is non epidemiological,
but rather because the Wise study itself is unreliable—and cites another Special Master decision
discussing, and discarding, that same study. Id. (citing Stapleford v. Sec’y of Health & Hum.
Servs., No. 03-vv-0234, 2009 WL 1456441, at *8 (Fed. Cl. May 1, 2009) (“[T]he Wise article[]
cannot reasonably be cited as evidence for a conclusion that the varicella vaccine can cause
seizures.”)). Thus, the Special Master did not require Ms. Dotson to proffer epidemiological
studies to support her claims, “he merely discounted the persuasiveness of the one proposed.”
Munoz v. Sec’y of Health & Hum. Servs., 174 Fed. Cl. 276, 289 (2024).
17 “In an attempt to show that the Special Master heightened her burden, [Ms. Dotson]
brings up the Wise paper again and then engages in a hypothetical discussion regarding statistical
significance and confidence intervals.” Resp. at 16–17. The Court agrees with Respondent that
this argument, premised on pure conjecture and speculation, and “devoid of any citations,” is
irrelevant to Ms. Dotson’s pending Motion, as it does not identify any evidence that the Special
Master failed to review, nor does it argue that the Special Master misapplied the law. See id. at
17. The Court therefore declines to address it.
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B. Neither the Special Master nor the Secretary Was Required to Disprove Ms.
Dotson’s Theory of Causation.
At various points throughout her Motion, Ms. Dotson contends that the Special Master
erred by not affirmatively disproving her theory of causation.18 See, e.g., Mot. at 27. For
example, she states, “[w]hat evidence is in this record that SM Moran could rely on to counter
this world class immunologist [and] all of the medical literature . . . ? The answer to this
question is NOTHING.” Id. Ms. Dotson similarly faults the Secretary for failing to disprove her
causative theory. See id. at 24 (arguing that the Special Master’s Decision should be reversed, in
part, because Dr. Kruer failed to provide commentary on Dr. Gershwin’s medical theory);19 id. at
27 (“Dr. Kruer provided no counter opinions.”); id. at 28 (referencing the lack of a “counter
medical opinion”) (contending that none of the “hundreds of medical articles filed in this case . .
. prove[] [] Dr. Gershwin is wrong”). In so arguing, Ms. Dotson “appears to misunderstand the
burden of proof.” Resp. at 6. “[T]he caselaw is clear,” id., “it is [Ms. Dotson’s] burden to prove
causation” in the first instance. W.C., 704 F.3d at 1359. “In Off-Table cases, petitioners bear the
burden to prove actual causation.” Bechel v. Sec’y of Health & Hum. Servs., 168 Fed. Cl. 602,
615 (2023). Neither the Secretary nor the Special Master bore “the burden of proving a prima
facie case.” Doe v. Sec’y of Health & Hum. Servs., 601 F.3d 1349, 1356 (Fed. Cir. 2010).
C. The Secretary Was Not Required to Show an Alternative Cause.
Ms. Dotson argues that the Special Master’s decision should be reversed because the
Secretary failed to present “any viable alternate cause.”20 Mot. at 38. Again, Ms. Dotson is
mistaken on the law—because the Special Master concluded that Ms. Dotson failed to meet her
burden of proof, and because this Court concludes that determination was well-supported and in
accordance with the law—“the Secretary [wa]s not obligated to present an alternative cause.”
Decision at 47.
It is well-settled that the framework articulated in Althen is a burden-shifting framework.
See Bechel, 168 Fed. Cl. at 616 (“If a petitioner presents adequate evidence on the three essential
aspects of causation, and thus makes a prima facie case for liability, the burden shifts to the
Government to prove, by a preponderance of evidence, an alternate cause of the alleged
18 The Court reviews this additional legal argument de novo. See Munn, 970 F.2d at 870
n.10; supra note 11.
19 The Court notes that it might very well have been exceedingly difficult, if not
impossible, for Dr. Kruer to provide substantive commentary refuting each of Dr. Gershwin’s
contentions, although he did in fact attempt to do so, because as the Special Master noted, Dr.
Gershwin’s attempts to “put forward a minimally competent medical theory fell well short.”
Decision at 31. Indeed, it was Dr. Kruer’s opinion that Dr. Gershwin failed to “proffer[] [any]
theory of causality” to which he could respond. Id. at 31–32 (quoting Ex. P at 3) (noting that Dr.
Kruer opined that “petitioner has not offered any cogent theory of causation”).
20 The Court reviews this additional legal argument de novo. See Munn, 970 F.2d at 870
n.10; supra note 11.
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injury.”); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). That
is, the Secretary is obligated to “show[], also by a preponderance of evidence, that the injury was
in fact caused by factors unrelated to the vaccine” if, and only if, petitioner first “satisfies [her]
burden” to preponderantly meet the three Althen prongs. LaLonde, 746 F.3d at 1338. In other
words, because Ms. Dotson “fail[ed] to establish a prima facie case, the burden [did] not shift to
Respondent.” Exum, 175 Fed. Cl. at 702; de Bazan, 539 F.3d at 1354 (“[T]his latter showing [to
preponderantly establish that the injury was caused by an alternate cause] is the government’s
burden once the petitioner has met her burden.” (emphasis added)). Thus, the Secretary was not
obligated to establish an alternate cause here.
CONCLUSION
Although the Court both understands and appreciates the pain Ms. Dotson experienced
watching her child suffer through a significant and life-altering medical ordeal, for the reasons
set forth herein, the Court finds that the Special Master’s determination that Ms. Dotson failed to
satisfy Althen prong one was neither arbitrary and capricious nor contrary to law. Ms. Dotson’s
Motion for Review, ECF No. 197, is therefore DENIED and the Special Master’s decision is
SUSTAINED. The Clerk shall enter JUDGMENT accordingly.
IT IS SO ORDERED.
________________________
ROBIN M. MERIWEATHER
Judge
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