S. v. Secretary of Health and Human Services

In the United States Court of Federal Claims
No. 16-1083 V
Filed: January 12, 2023
Re-issued: February 13, 20231
)
J.S., )
)
Petitioner, )
)
v. )
)
SECRETARY OF HEALTH )
AND HUMAN SERVICES, )
)
Respondent. )
)
Robert J. Krakow, Law Office of Robert J. Krakow, P.C., for Petitioner.
Zoe Wade, Trial Attorney, United States Department of Justice, Torts Branch, Civil Division,
Washington, D.C., for Respondent.
OPINION AND ORDER
MEYERS, Judge.
Pending before the Court is J.S.’s petition for review of the Chief Special Master’s
decision denying her claim for compensation under the National Vaccine Injury Compensation
Program. Petitioner contends that she developed postural orthostatic tachycardia syndrome and
inappropriate tachycardia from her vaccinations for Hepatitis A and human papillomavirus. The
Chief Special Master concluded that Petitioner’s medical records did not establish either injury
by a preponderance of the evidence in this case; rather, the record indicated that it was more
likely that other causes led to her symptoms. And the Chief Special Master concluded that
Petitioner’s theory that the vaccines at issue could cause the claimed injuries would, in any
event, fail to establish causation in this case. Therefore, he denied Petitioner’s claim. Because
the Chief Special Master considered the evidence before him and articulated a reasoned basis for
his conclusion, the Court sustains the Chief Special Master’s decision denying entitlement.
I. FACTUAL AND PROCEDURAL BACKGROUND
1
The Court initially filed this opinion under seal to allow the Parties to propose redactions. This
re-issued opinion has incorporated the proposed redactions.
J.S. filed her petition for compensation under the National Childhood Vaccine Injury Act
of 1986 (the “Vaccine Act”), 42 U.S.C. § 300aa-10 to 34 (2018), on August 30, 2016, alleging
that receipt of the Hepatitis A (“Hep. A”) and human papillomavirus (“HPV”) vaccines caused
her to develop inappropriate tachycardia,2 autonomic dysfunction, and postural orthostatic
tachycardia syndrome (“POTS”).3 ECF No. 1 ¶¶ 18-20 (“Pet.”). Specifically, Petitioner claimed
that she experienced “convulsions, shortness of breath, rapid heartbeat, . . . loss of feeling in her
left leg[,] . . . pain in her joints, hyperventilation, heart palpitations, dizziness, [and] nausea, . . .
[which] were caused-in-fact by her Gardasil vaccination received on August 19, 2015.” Pet. at 3,
¶¶ 18-20. “Approximately one day after receiving the Gardasil HPV vaccination, and 16 days
after receiving . . . a Hepatitis A vaccination, [Petitioner] experienced the onset of these
conditions.” ECF No. 114 at 2.
On April 20, 2017, Petitioner filed a motion to substitute counsel and a motion requesting
interim attorney’s fees and costs for her prior counsel. ECF Nos. 30 & 31. On June 7, 2017,
Special Master Sanders issued an Order Deferring Resolution of Petitioner’s request for fees,
finding that it was speculative to determine whether the proceedings would become protracted at
that stage, and it would have been “extremely difficult to determine the case’s reasonable basis”
without Respondent’s position in the record. ECF No. 40 at 4-5. On August 2, 2018, Special
Master Sanders issued a Decision Awarding Interim Attorney’s Fees and Costs, with certain
reductions to the amount requested. ECF No. 72.
Respondent filed its Rule 4(c) Report on June 12, 2017, asserting that, “Congress
authorized the Vaccine Program to compensate only those individuals who can substantiate their
claims either through a presumption of causation (i.e., proof of a Table case) or by proving a
causal link between the alleged injuries and a covered vaccine[,] . . . [and] petitioner has not met
her prima facie burden to show causation-in-fact . . . .” ECF No. 41 at 11. In response,
Petitioner submitted “a 19-page memorandum, ECF No. 42, clarifying and correcting points
contained in Respondent’s Rule 4(c) Report[,] . . . [which] form[s], in part, the basis of
Petitioner’s challenge to the Decision in the Motion for Review.” ECF No. 114 at 2-3.
Thereafter, the Parties collectively “filed ten expert reports, offering competing takes on a
causation theory . . . that the HPV and Hep. A vaccines can stimulate the production of
autoantibodies that could be causal of autonomic disfunction, primarily manifesting as
2
Tachycardia is “excessive rapidity in the action of the heart” and sinus tachycardia is
“tachycardia originating in the sinus node.” ECF. No. 114 at 1-2 n.1 (internal citations omitted).
“Inappropriate sinus tachycardia, also called chronic nonparoxysmal sinus tachycardia, is an
unusual condition that occurs in individuals without apparent heart disease or other cause for
sinus tachycardia, such as hyperthyroidism or fever, and is generally . . . defined as a resting
heart rate >100 beats per minute (with a mean heart rate>90 beats per minute over 24 hours)
associated with highly symptomatic palpitations . . . .” Id.
3
“POTS is a circulation disorder characterized by a group of symptoms (not including
hypotension) that sometimes occur when a person assumes an upright position, including
tachycardia, tremulousness, lightheadedness, sweating, and hyperventilation.” ECF No. 109 at
26 (citing Postural orthostatic tachycardia syndrome, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=111236 (last visited July 14, 2022)).
2
orthostatic intolerance.” ECF No. 109 at 2. Summaries of Petitioner’s medical records and each
Party’s expert opinions are set forth in detail below.
On July 12, 2018, the Parties informed the Court that they were not engaged in settlement
discussions and requested a hearing date. See ECF No. 72 at 4. That day, Special Master
Sanders issued an Order providing that “[d]ue to the high volume of cases that are ready for
entitlement hearings and the limited number of Special Masters, no additional hearings will be
scheduled until further notice. Chambers will reach out to the parties when hearing dates become
available.” ECF No. 71. In March 2021, this case was reassigned to Chief Special Master
Corcoran, who directed the Parties to conclude filing expert reports and briefings, and indicated
that the matter would be resolved by a ruling on the record. See Docket Entry Order, dated
March 23, 2021. The Chief Special Master issued his Decision on July 15, 2022. ECF No. 109.
A. Petitioner’s Medical History
1. Pre-Vaccination Medical History
Petitioner was born on March 3, 1997. Pet’r’s Ex. 2 at 1 (ECF No. 6-2). Petitioner
claims that her health had been generally “stable” prior to receiving the Hep. A and HPV
vaccinations at issue, and “the emergence of symptoms [did not occur until] after the August 4,
2015 and August 19, 2015 vaccinations.” ECF No. 114 at 8-9. In issuing his decision the Chief
Special Master reviewed the administrative record, including Petitioner’s relevant medical
history, and identified “three notable events” based on her pre-vaccination medical records:
First, she saw a cardiologist in June 2008 for episodes of shortness of breath and
difficulty breathing while swimming, but her symptoms were later attributed to asthma.
Second, she underwent a head MRI on October 1, 2008, for occipital migraines, which
showed evidence for sinusitis, but was otherwise normal. Finally, in March 2012 she was
evaluated by an endocrinologist for autoimmune thyroid disease. At that time, she tested
positive for antibodies relevant to the disease, but was not yet symptomatic, although she
did report joint aches and ongoing abdominal complaints.
ECF No. 109 at 2 (citing Pet’r’s Ex. 2 at 55-56, 58-61 (ECF No. 6-2); Pet’r’s Ex. 15 at 1-2 (ECF
No. 12-1)).
Petitioner contests the significance of each “notable event[]” cited by the Chief Special
Master. First, Petitioner argues that, although the June 10, 2008, medical report suggests
“episodes of shortness of breath and difficulty breathing while swimming” related to asthma, the
“record shows no diagnosis or other reference to asthma or reactive airway disease.” ECF No.
114 at 7 (citing Pet’r’s Ex. 3 at 58-62 (ECF No. 6-3)) (emphasis in original). However, pursuant
to the 2008 report, “[a]n electrocardiogram was preformed which . . . show[ed] sinus rhythm
alternating with an atrial ectopic rhythm.” Pet’r’s Ex. 3 at 58 (ECF No. 6-3). While Petitioner’s
treating physician indicated this was “nothing of concern by itself[,]” he found Petitioner’s
“symptoms appear more compatible with reactive airway disease than the classic cardiac
findings of syncope in a pool with relevant family history.” Id. at 59. Second, Petitioner
concedes she submitted to an MRI in October 2008, which was “normal, except for noting
3
evidence of sinusitis.”4 ECF No. 114 at 8. She suggests, however, that the MRI was intended to,
and did in fact, rule out occipital migraine as cause for her eye pain, loss of vision, and nausea,
thereby failing to render it “notable.” Id. at 7-8; see Pet’r’s Ex. 3 at 10 (ECF No. 6-3). Finally,
Petitioner agrees that her “thyroid functioning was normal, despite the presence of antibodies
indicative of autoimmune thyroid disease” in 2012. ECF No. 114 at 8. Specifically, she
“presented to Riverview Medical Center on August 17, 20125 with a history of diarrhea, fever,
nausea, abdominal pain, nasal discharge, fatigue, and cough . . . [and] had slightly positive tests
for campylobacter jejuni and Coxsackie A and B viruses.” Id. at 9; see Pet’r’s Ex. 7 at 281-300
(ECF No. 6-9). These tests indicated “strong evidence of current or recent infection.” Pet’r’s
Ex. 7 at 292-93 (ECF No. 6-9).
2. Post-Vaccination Hospitalizations
Petitioner received the Hep. A vaccine on August 4, 2015, and the first dose of the
Gardasil HPV vaccine on August 19, 2015. Pet’r’s Ex. 3 at 29 (ECF No. 6-3). On August 20,
2015, Petitioner began experiencing anxiety and hyperventilation, and sought treatment at
Riverview Medical Center. Pet’r’s Ex. 7 at 211-13 (ECF No. 6-9). There, Petitioner reported
experiencing recent feelings of sadness, was planning to leave for college the next day, and,
according to a Nurse’s Note, that she “broke up with [her] boyfriend.”6 Id. at 224. The treating
physician diagnosed her with an “anxiety reaction” and instructed her to follow up with a
psychologist in one to two days. Id. at 229. The next day, Petitioner returned to the hospital by
ambulance, again complaining of anxiety. Id. at 180-84. She appeared distressed to a degree
“inappropriate for [her] age” and underwent a complete blood panel, metabolic panel, toxicology
screen, and pregnancy test—each resulting in negative or noncontributory findings. Id. at 180-
84, 187. She was ultimately discharged with a prescription for Ativan to take as needed for her
diagnosed anxiety reaction. Id. at 189-90, 192.
On August 22, 2015, Petitioner returned to the hospital by ambulance. She appeared
awake, anxious, and to experience “twitching” movements. Pet’r’s Ex. 6 at 57, 72 (ECF No. 6-
7). She transferred to Jersey Shore Hospital for further evaluation and heightened care. Id. at
57-58, 72. Petitioner reported experiencing “3 days of episodes of tonic-clonic jerking that last
20-40 minutes each and are associated with hyperventilation.” Id.at 77. She also indicated this
“[j]erking involves all 4 extremities. . . . [She] has never had episodes like this before. . . . [She]
reports having a headache with mild sensitivity to light but states it is normal for her as she has a
4
Petitioner’s MRI radiology report references a history of occipital migraines, while otherwise
finding “[n]ormal magnetic resonance imaging of the brain” with “nonspecific . . . evidence of
left-sided maxillary sinus . . . .” Pet’r’s Ex. 3-1 at 56-57 (ECF No. 6-3).
5
Petitioner takes issue with Respondent’s “incorrect reporting of dates, [which suggests] that
Petitioner’s symptoms predated her August 4, 2015 Hepatitis A and August 19, 2015 Gardasil
vaccinations . . . .” ECF No. 114 at 8-9 n.6. Indeed, the correct date of Petitioner’s visit is
August 17, 2012, rather than August 17, 2015, as included in Respondent’s briefing. Pet’r’s Ex.
7 at 281-300 (ECF No. 6-9).
6
Petitioner disputes that she had broken up with her boyfriend and argues the hospital record is
incorrect on this point. However, resolution of this fact does not impact the resolution of this
case.
4
h/o [history of] migraines.” Id. The medical intake form does not reference Petitioner’s hospital
visits over the preceding three days—only that she visited the “ER . . . (not admitted) for MVA 3
months ago.” Id. Petitioner received an initial diagnosis of “pseudoseizures”7 while treating
physicians continued to evaluate her. Id. at 38, 40-42, 80, 131.
Petitioner submitted to a video EEG on August 23-24, 2015, which was normal despite
jerking episodes not accompanied by electrical discharge. Id. at 92; see also id. at 40 (“EEG has
shown that [Petitioner] has not had any seizure-like activity.”). Petitioner also underwent
consultations for infectious diseases (Dr. Davis), neurological disorders (Dr. Sultan), and
psychiatric conditions (Dr. Vincent), acknowledging her recent trip to Nicaragua and familial
history of autoimmune issues, including a grandmother with myasthenia gravis. Id. at 33-42.
Dr. Davis “observed the temporal association with [Petitioner’s] receipt of the first HPV dose,
and even wondered whether she may have had an adverse reaction, but felt that her symptoms
would resolve with time.” ECF No. 109 at 4 (citing Pet’r’s Ex. 6 at 35 (ECF No. 6-7)). Dr.
Sultan cited acute anxiety disorder, indicating Petitioner was unlikely experiencing “myoclonic
seizure,” while failing to rule out PANDAS8 variant, underlying cardiac pathology, and reaction
to the Gardasil vaccine. Pet’r’s Ex. 6 at 38 (ECF No. 6-7). Dr. Vincent diagnosed Petitioner
with panic attacks and advised her to seek therapy at college, although he did not rule out
possible vaccine reaction or neurological issues. Id. at 42. The attending physician, Dr. Chin,
also found Petitioner’s “[c]ardiac evaluation [to be] normal, and [her symptoms] unlikely to be
related to an underlying cardiac etiology.” Id. at 130. On August 26, 2015, Dr. Topilow
submitted a Vaccine Adverse Event Reporting System report highlighting Petitioner’s
“twitching” and “jerking” symptoms following the HPV vaccine administered on August 19,
2015. Pet’r’s Ex. 3 at 37 (ECF No. 6-3). Petitioner’s final diagnosis was “[a]nxiety based events
not related to vaccine.” Pet’r’s Ex. 6 at 131 (ECF No. 6-7).
On September 2, 2015, Dr. Wells, a neurologist at NYU, further evaluated Petitioner.
She described for him several episodes of “prolonged tachycardia” and “myoclonic jerking”
initiating on August 20, 2015. Pet’r’s Ex. 21 at 1-6 (ECF No. 28-1). Dr. Wells reviewed a video
of an episode taken on Petitioner’s mother’s smartphone and was unable to determine if the
“jerking” movements were involuntary. Id. at 4. Dr. Wells concluded that Petitioner “appears to
be having episodes that are primarily anxiety based. They are unlikely to be seizures given the
normal video EEG while having myoclonic episodes.” Id. He surmised that the Gardasil
vaccination is an unlikely cause for her symptoms and, rather, recommended that she visit a
therapist for counseling. Id.
7
“A pseudoseizure is ‘an attack resembling an epileptic seizure but being a type of conversion
disorder; it lacks the electroencephalographic characteristics of epilepsy and the patient may be
able to stop it by an act of will.’” ECF No. 109 at 3 n.5 (citing Pseudoseizure, Dorland’s Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=111236 (last visited
July 14, 2022)).
8
“‘PANDAS’ stands for Pediatric Autoimmune Neuropsychiatric Disorder Associated with
Streptococcus infections.” ECF No. 109 at 4 n.6 (citing Bains v. Sec’y of Health & Hum. Servs.,
No. 18-1212V, 2019 WL 4121084, at *1 (Fed. Cl. Spec. Mstr. July 26, 2019)).
5
On September 12, 2015, Petitioner went to the emergency room at Rhode Island Hospital
complaining of “shaking, tremor episodes, . . . myoclonic jerks . . . [and] her joints beginning to
‘lock up . . . .’” ECF No. 114 at 11 (citing Pet’r’s Ex. 5 at 3-4 (ECF No. 6-6)). Petitioner’s
mother, who accompanied her to the hospital, informed physicians “that these reactions increase
with loud noises[,] ‘when she is startled and scared[,]’ . . . [and are] exacerbated by stressful
factors.” Pet’r’s Ex. 5 at 3-4 (ECF No. 6-6). The hospital administered an ECG, which was
negative, and reviewed prior psychologist consultation records, which indicated anxiety may be
causing her symptoms. Id. at 4, 15.
Five days later, on September 17, 2015, Petitioner was admitted to Riverview Medical
Center “under observation status with intravenous Ativan on call for seizure-like activity.”
Pet’r’s Ex. 7 at 90 (ECF No. 6-8). The results of her ECG were “normal” noting “normal sinus
rhythm with sinus arrhythmia.” Id. at 46. A subsequent neurology consultation suggested
“[p]robable pseudoseizures.” Id. at 67. The neurologist reported Petitioner’s condition “[s]eems
to be some stress related psycho-somatization[,] somatization . . . [or] anxiety associated panic . .
. from ongoing stress” rather than “post-vaccine complication[s] causing seizures.” Id. He
advised “further psych evaluation and treatment for . . . psycho-somatization or psych disorder”
if Petitioner’s evaluation for seizures continued to yield negative results. Id.; see Pet’r’s Ex. 9 at
25 (ECF No. 7-1) (describing “negative imaging, negative vEEG, and negative infectious
workup”).
Petitioner transferred to New York Hospital on September 18, 2015, for further
evaluation. There, her laboratory testing, autoimmune testing, and EKG were normal. Pet’r’s
Ex. 7 at 77-80, 130 (ECF No. 6-8); Pet’r’s Ex. 9 at 62 (ECF No. 7-1). A two-day video EEG
captured a “shaking episode” following a BP reading of 79/52, “but there was no evidence of
seizure activity on the EEG. The vEEG findings, along with the long duration of most of her
episodes (20-40 minutes), lack of tongue biting and incontinence, and maintenance of
awareness/verbal communication point towards a psychogenic non-epileptic seizure
(pseudoseizure).” Pet’r’s Ex. 9 at 62, 64, 70 (ECF No. 7-1) (“One of her typical spells was
captured, characterized by jerking and shaking movements with no EEG correlation[.] [These]
findings indicate nonepileptic events.”). Accordingly, Petitioner was “cleared from neurologic
perspective [and] discharged home with follow up.” Id. at 66. A pediatric resident reviewed
Petitioner’s concerns regarding the onset of symptoms following receipt of the HPV vaccination,
commenting that “[the] literature largely disclaims an association between the vaccination and
neurologic disease . . . [and] most likely this is not the underlying etiology.” Id. at 58.
Additionally, a neurology attending noted that Petitioner’s condition is “compelling for
psychogenic spells” and encouraged “therapeutic intervention” to address “an underlying
subconscious stressor causing the events.” Id. at 70-71. Petitioner was discharged on September
22, 2015. Id. at 71.
3. 2015 Medical Evaluations
On October 2, 2015, Petitioner saw Dr. Lefkowitz, a cardiologist. Pet’r’s Ex. 3 at 92
(ECF No. 6-4). Dr. Lefkowitz reviewed Petitioner’s medical history, acknowledging that her
prior “video EEG . . . showed no seizure activity during myoclonic activity” and noting
Petitioner’s record of IgA deficiency, antithyroid antibodies, and anti-insulin antibodies. Id. Dr.
Lefkowitz conducted a “sit-stand” test, which revealed an increase in heart rate, from 62 bpm to
6
99 bpm, but no corresponding increase in blood pressure. Id. at 93. He also administered a 24
Hour Holter Report, which indicated Petitioner’s “maximum heart rate was 150 bpm . . . during
sinus tachycardia” and she experienced “46 runs of supraventricular tachycardia/paroxysmal
atrial tachycardia.” Pet’r’s Ex. 12 at 12 (ECF No. 7-4). After completing his examination, Dr.
Lefkowitz provided the following findings:
Problem #1: Shy-Drager syndrome9 (ICD-333.0) (ICD10-G90.3) The patient appears to
have developed generalized autonomic dysfunction either on the basis of a reaction to her
various vaccines that occurred at the same time, or possibly on the basis of a viral
syndrome that she acquired while traveling through the jungles of Central America. Her
MRI was apparently difficult to interpret in terms of demyelination, and should be
reevaluated. She does respond to fluids and hydration, and to salt intake. This syndrome
whether a self-limited immune response to the vaccine, i.e. a form fruste of multiple
sclerosis, or a viral response which was stimulated immune reaction such as is seen in
Guillain-Barre syndrome, with both ultimately be self-limited. They would respond to
fluid intake, and a slow increase in exercise tolerance. I believe that this will be self-
limited. I do believe she should hydrate aggressively with G2 or Smart water, and I
believe that we have shown that the tonic-clonic movements are unrelated to seizure
activity based upon the EEG. She also had no loss of urine or bowel. I think the final
answer regarding the tonic-clonic movements will depend on either a different
interpretation of the MRI, or perhaps a repeat MRI.
Problem #2: Palpitations, recurrent (ICD-785.1) (ICD10-R00.2) The patient's Holter is
consistent with inappropriate sinus tachycardia. This can be seen in the setting of
autonomic dysfunction. While I believe the autonomic dysfunction is on the basis of
either vaccines, or viral exposure, this should be a way to address whether or not the
antibody to insulin can cause autonomic dysfunction in the setting of a diabetic-like state.
I doubt that this is the case. Thyroid function testing was unremarkable, therefore she is
not hyperthyroid despite the presence of antibodies. The palpitations and inappropriate
sinus tachycardia should respond to fluids and rest, but I'm going to prescribe low-dose
metoprolol to take when they become very uncomfortable. Eventually I suspect she will
no longer needs to beta-blockade over time. Fortunately, there is no evidence of
malignant arrhythmia, or an arrhythmia that would need to be ablated.
Problem #3: Chest pain, precordial (ICD-786.51) (ICD10-R07.2) The chest pain is a little
bit more difficult to explain. The patient has a normal EKG, and normal left ventricular
function. Her right side is not dilated, and pulmonary artery systolic pressures are normal,
so I don't think it is likely that she had a pulmonary embolus that would cause her to have
pain. Her oxygen saturation is normal as well. . . . Whether or not the chest pain is
secondary to pericarditis, is unclear. While she has evidence of concordance of the
9
“Shy-Drager syndrome is another term for multiple system atrophy (“MSA”)—‘a rare,
degenerative neurological disorder affecting your body’s involuntary (autonomic) functions,
including blood pressure, breathing, bladder function and motor control.’ It shares many
Parkinson’s disease-like symptoms, such as slow movement, rigid muscles, and poor balance.”
ECF No. 109 at 7 (quoting ECF No. 106 at 8 n.6).
7
pericardium, there is no evidence of pericarditis on her EKG, and sedimentation rate and
CRP are both normal. If she had pericarditis, she had it in the past in my opinion. . . .
Problem #4: Symptom, convulsions NOS (ICD-780.39) (ICD10- R56.9) As outlined
above, there is no correlation with seizure activity on EEG. This may be some reaction of
the central nervous system 20 over the median stimulant this. I await the repeat MRI
interpretation, and possibly a repeat neurology evaluation.
Pet’r’s Ex. 3 at 93-94 (ECF No. 6-4).
On October 13, 2015, Petitioner saw Dr. Nash, an infectious disease and pulmonary
specialist. Dr. Nash found the psychogenic seizure diagnosis incompatible with her clinical
presentation and personality/behavior presentation. Pet’r’s Ex. 4 at 3 (ECF No. 6-5).
Specifically, Dr. Nash commented that “the multiplicity of [Petitioner’s] symptoms (twitching,
shortness of breath, fever, chest pain) is well beyond what one would expect from
straightforward panic/anxiety reaction.” Id. He suggested “[t]he timing of her symptoms and the
immunizations may represent coincidence or perhaps that she had a degree of autoimmune
encephalopathy provoked by immunizations in a susceptible patient with an autoimmune
predisposition.” Id. Alternatively, he considered whether her symptoms could be caused by “an
infection that she picked up while in Nicaragua.” He concluded that the infections “that would
cause CNS symptoms typically are associated with eosinophilia and an abnormal MRI.” Id. He
also opined that “[s]he has minor orthostatic changes which are not consistent with POTS or
significant autonomic instability.” Id. Dr. Nash recommended further testing for inflammation
and infection, autoimmune encephalitis, and cerebral spinal fluid evaluation for seizure-like
activities. Id. Such testing yielded unremarkable results that did not corroborate the presence of
an autoimmune condition or autonomic dysfunction. See Id. at 7 (MRI results showing white
matter disease “associated with migraine headaches, vasculopathy, toxins, prior trauma, or prior
inflammatory diseases, all of which can give a similar appearance.”).
On November 18, 2015, Dr. Kaufmann and Dr. Palma—both neurology specialists in
dysautonomia—submitted Petitioner to neurological, autonomic, and paraneoplastic autoimmune
testing. Pet’r’s Ex. 18 at 1-3 (ECF No. 18-1). Such testing included a “tilt table” test,10 during
which Petitioner experienced “an episode of bilateral convulsive movements with no loss of
consciousness accompanied by palpitations, sinus tachycardia, and shortness of breath.” Id. at 3.
Petitioner’s blood pressure rose from 108 to 136 after 11 minutes of head-tilt, and her plasma
concentration of norepinephrine increased from 252 to 619 when tilted. Id. The results of the
autoimmune panel revealed no abnormal antibodies, and Petitioner “preserved cardiovascular
autonomic reflexes with no evidence of orthostatic hypotension.” Id. Further, her testing
indicated that Petitioner’s “observed episode, as well as her previous episodes[,] are consistent
with non-epileptic seizures.” Id. Testing did not establish that Petitioner suffered from POTS.
10
“The standard tilt table test entails the patient remaining in a supine position on an adjustable
table for twenty minutes, followed by ten minutes tilted upright, with the heart rate and blood
pressure measured minute by minute, to detect changes as position is altered.” ECF No. 109 at 7
(citing Yalacki v. Sec’y of Health & Hum. Servs., No. 14-278V, 2019 WL 1061429, at *40 n.10
(Fed. Cl. Spec. Mstr. Jan. 31, 2019), mot. for review den’d, 146 Fed. Cl. 80 (2019)). This test is
“often considered the ‘gold standard’ in diagnosing POTS.” Id.8
Dr. Kaufmann and Dr. Palma concluded that “[t]he marked increase in circulating epinephrine
(from 17 to 160 pg/ml) . . . typically occurs in panic disorders.” Id.; see also ECF No. 109 at 8
n.11 (“Epinephrine is a hormone released by the adrenal glands in response to stress”). The
neurologists explained to Petitioner “how repeated panic attacks result in reuptake of epinephrine
by sympathetic nerves, and as result, episodes of sympathetic activation, like exercise, may
produce excessive epinephrine release and panic-like symptoms.” Pet’r’s Ex. 18 at 3 (ECF No.
18-1). Accordingly, they suggested techniques to improve symptoms, which included “cognitive
behavioral therapy, biofeedback[,] . . . mindfulness, yoga[,] breathing . . . [and] [b]eta-blockade
(e.g., Toprol)[,] [which] is successful for managing stage fright and other stressful situations . . .
.” Id.Later that month, Petitioner had a follow-up appointment with Dr. Lefkowitz, where she
reported feeling “less orthostatic” and “much better overall.” Pet’r’s Ex. 3 at 97 (ECF No. 6-4).
She also stated that “[s]he no longer has palpitations, dizziness, or tremors.” Id. Dr. Lefkowitz
found her “asymptomatic” with respect to shy-drager syndrome, which had “[c]linically much
improved.” Id. at 98. He also suggested “whatever the immunoresponse that stimulated [her
convulsions] resolved nearly completely.” Id.
Despite these improvements, Petitioner was admitted to the emergency department at
Robert Wood Johnson University Hospital on December 5, 2015, exhibiting “convulsions.”
Pet’r’s Ex. 11 at 2 (ECF No. 7-3). The intake report indicates that, according to Petitioner’s
mother, she “has had pseudo-seizures since August when she received [her] first round of
Gaurdasil [sic].” Id. The initial assessment provided that Petitioner “is a 18 year old with IgA
deficiency presenting after sudden loss of consciousness and left lower extremities weakness
with likely etiology autonomic dysfunction secondary to Gardasil vaccination.” Id. at 72. While
her laboratory tests were normal, an EKG showed sinus tachycardia. Id. at 8-10.
A few days later, Petitioner was admitted to the Monmouth Medical Center Emergency
Department, complaining of “generalized body aches . . . with mild sore throat” and “occasional
chest pressure.” Pet’r’s Ex. 3 at 88 (ECF No. 6-4). The intake report now noted “a history of
POTS” and “extensive evaluation for episodes of tachycardia, leg weakness and pseudoseizures
following her initial immunization of Gardasil several years ago.” Id. at 88. While admitted,
Petitioner experienced an episode of chest pain and tachycardia; however, the ECG, EKG,
cardiac monitor, and oxygenation levels remained normal. Id. at 91. Dr. Snyder subsequently
ordered her discharge and “encouraged strongly the child start[] beta blockers11 for prevention.”
Id.
4. 2016-2020 Medical Evaluations and Treatment
In February 2016, Dr. Lefkowitz submitted Petitioner to Zio Patch Electrocardiography
Monitoring for two weeks. Pet’r’s Ex. 12 at 4 (ECF No. 7-4). The results showed a maximum
heart rate of “203 bpm which occurred during a 13 beat or 6.4 second run of ventricular
11
“Beta blockers, also known as beta-adrenergic blocking agents, can be recommended for
reducing anxiety, because they inhibit the effects of adrenaline.” ECF No. 109 at 9 n.13 (citing
Beta Blockers, Mayo Clinic, https://www.mayoclinic.org/diseases-conditions/high-blood-
pressure/in-depth/beta-blockers/art-20044522 (last accessed on June 30, 2022)).
9
tachycardia” as well as instances of premature atrial and ventricular contractions and paroxysmal
atrial tachycardia. Id. “There was no supraventricular tachycardia” and “no atrial fibrillation or
atrial flutter.” Id. Nevertheless, on June 26, 2016, Dr. Lefkowitz provided Petitioner with a
letter that indicated he “diagnosed her with an autonomic disfunction due to the HPV vaccine . . .
. [and,] [a]s a result of this, she cannot complete the course of the HPV vaccine.” Id. at 3. The
letter also cleared Petitioner to return to college “without restriction.” Id.
In April 2016, Petitioner went to Riverview Medical Center complaining of nausea,
vomiting, and abdominal pain. Pet’r’s Ex. 13 at 10 (ECF No. 9-1). Her medical history, as
reported, included POTS disease and a history “of being immunocompromised secondary to the
Gardasil vaccination.” Id. She was discharged following a physical evaluation, which did not
yield abnormal results. Id.
In September 2016, Petitioner arrived at Roger Williams Medical Center exhibiting body
tremors and hyperventilation. Pet’r’s Ex. 14 at 2 (ECF No. 10-1). While her physical evaluation
was normal, an EKG showed sinus tachycardia. Id. In November, Petitioner returned to the
emergency room “for evaluation of near syncopal episode and tachycardia onset . . . secondary to
missing a dose of Metoprolol . . . .” Pet’r’s Ex. 29 at 32 (ECF No. 56-1). She was “informed
that [she] may have pre-hypertension and hypertension based on a blood pressure reading” and
was discharged after her condition improved. Id. at 34.
In April 2017, Petitioner returned to the emergency room complaining of possible
tachycardia and seizure. Id. at 60. Her blood pressure was documented as high, in the 150s, and
her “blood pressure was fluctuating.” Id. Treating physicians reiterated that she “may have pre-
hypertension and hypertension based on a blood pressure reading” and recommended following
up with her primary care provider following discharge. Id. at 63.
In October 2017, Dr. Lefkowitz performed an echocardiogram in reaction to Petitioner’s
claim of “chest pain.” Dr. Lefkowitz also recommended an MRI to evaluate an intermittent mass
near her heart. Pet’r’s Ex. 33 at 26. Dr. Lefkowitz identified myxoma12 as possible explanation
for her presentation. Pet’r’s Ex. 33 at 27 (ECF No. 60-1). He also indicated Petitioner’s “blood
pressure goes up and her heart rate goes down as opposed to the opposite which would be more
consistent with potts [sic] syndrome.” Id. at 26. Testing suggested Petitioner’s symptoms were
“consistent with massive activation” and her pulse and blood pressure were “consistent with
orthostasis.” Id. Additionally, Petitioner’s vivid dreams, anemia, abdominal pain, and nausea
“could be associated with porphyria.” Id.
Petitioner’s medical records indicate that she did not seek medical attention again until
March 28, 2019, when she presented to North Attleboro Urgent Care with complaints of
abdominal pain. Pet’r’s Ex. 36 at 4 (ECF No. 77-1). A CT scan revealed “no acute intra-
abdominal or pelvic abnormality” and was otherwise negative, except for “[l]arge fecal loading
of the entire colon.” Id. at 25. The following year, in March 2020, Petitioner consulted Dr.
12
“Myxoma is ‘a benign tumor composed of primitive connective tissue cells and stroma
resembling mesenchyme.’” ECF No. 109 at 10 n.14 (citing Myxoma, Dorland’s Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=111236 (last visited
July 14, 2022)).
10
Vargas, a neurologist, regarding “an abnormal MRI and cognitive complaints.” Pet’r’s Ex. 38 at
12 (ECF No. 77-3). Dr. Vargas reported that “[s]ince our last visit, [Petitioner] had labs which
were WNL [within normal limits].” Id. at 12. She also indicated that Petitioner’s MRI “was
stable in terms of lesions but did show a tiny 3 mm hypoenhancing focus related to the pituitary
gland.” Id. at 12.
In 2016 and 2020, Petitioner submitted blood samples for further antibody laboratory
testing. CellTrend GmbH, a laboratory in Germany, tested Petitioner for adrenergic and
muscarinic antibodies13 in February 2016, two of which were found to be positive. Pet’r’s Ex.
16 at 1-2 (ECF No. 12-2). Further, results received in August 2016 indicated high levels of GAD
antibodies, IA-2 antibodies, Zinc Transporter 8 antibodies, and antinuclear antibodies (ANA).
Pet’r’s Ex. 15 at 11 (ECF No. 12-1). Four years later, in March 2020, Petitioner was retested by
CellTrend GmbH.14 The results showed positive levels of Anti alpha-1 adrenergic antibodies
measuring 19.4 Units/ml, Pet’r’s Ex. 37 at 1 (ECF No. 77-2), which exceeded the 2016
measurement of 7.1 Units/ml.1, Pet’r’s Ex. 16 at 1 (ECF No. 12-2). Petitioner’s results were
otherwise negative, except for one at risk value for Anti ETAR antibodies, which measured at
12.1 Units/ml. Pet’r’s Ex. 37 at 1 (ECF No. 77-2). The following month, Petitioner underwent
testing for neuromuscular antibodies at Washington University School of Medicine. The results
were negative, except one “borderline” positive reading for IgM vs Neurofascin-155, which “has
been associated with chronic and acute neuropathies with distal weakness, sensory loss and
tremor.” Pet’r’s Ex. 40 at 1 (ECF No. 77-5).
B. Expert Opinions
Petitioner relies upon expert opinions to show that her HPV vaccination caused her
claimed injuries, and Respondent relies upon expert opinions to show that Petitioner’s HPV
vaccination did not cause her claimed injuries. See ECF No. 41 at 10-11, ECF No. 43 at 1.
Ultimately, the Chief Special Master reviewed ten expert reports from four medical experts. See
Ex. 28 (ECF No. 49-1), Ex. A (ECF No. 63-1), Ex. C (ECF No. 65-1), Ex. 35 (ECF No. 68-1),
Ex. E (ECF No. 70-1), Ex. 49 (ECF No. 92-1), Ex. 60 (ECF No. 93-1), Ex. F (ECF No. 99-1),
Ex. G (ECF No. 99-14), and Ex. 63 (ECF No. 100-1).
1. Dr. Steinman’s First Report
Petitioner’s initial expert report is by Dr. Lawrence Steinman. See Pet’r’s Ex. 28 (ECF
No. 49-1). Dr. Steinman is a neurologist who has practiced adult and pediatric neurology for 37
years. Id. at 1. He is also Professor of Neurology at Stanford University. Id.
13
Petitioner filed medical literature indicating a possible connection between positive adrenergic
and muscarinic antibodies and patients diagnosed with POTS. See Pet’r’s Ex. 23 (ECF No. 42-
5). The report further suggested “[t]he temporal relationship of . . . symptoms to HPV
vaccination and the detection of numerous relevant antibodies raise[s] the hypothesis of an
autoimmune basis for [the] symptoms.” Id.
14
Petitioner indicated that such testing was secured to support an autoimmune etiology
evidenced by elevated norepinephrine levels. ECF No. 108 at 6-7.
11
Dr. Steinman concluded “by a preponderance of evidence” that “the Hepatitis A vaccine
received by J.S. on August 4, 2015, and the Gardasil vaccine received by J.S. on August 19,
2015” caused Petitioner to develop an “autoimmune dysautonomia with inappropriate
tachycardia.” Id. at 18. Dr. Steinman’s theory is based “on the concept of molecular mimicry.”
Id. at 6. According to his theory, “a vaccine can trigger a cross-reactive autoimmune response
directed to self” when the vaccine contains an “effective molecular mimic.” Id. at 6-9. An
effective molecular mimic is one that is “capable of inducing clinical paralysis when injected
into an experimental animal of the right genetic background,” a standard Dr. Steinman based on
two peer reviewed papers. Id. at 9; see A. Guatam, A Viral Peptide with Limited Homology to a
Self Peptide Can Induce Clinical Signs of Experimental Autoimmune Encephalomyelitis, 161 J.
Imunol. 60 (1998), filed as Ex. 28, Ref. 16 on Oct. 29, 2017 (ECF No. 48-7); A. Guatam,
Minimum Structural Requirements for Peptide Presentation by Major Histocompatibility
Complex Class II Molecules: Implications in Induction of Autoimmunity, 91 Proc. Natl. Acad.
Sci. USA 767 (1994), filed as Ex. 28, Ref. 17 on Oct. 29, 2017 (ECF No. 48-8). According to
these papers, paralysis was induced when vaccine components shared “a stretch of 12 amino
acids where at least 5 are identical” with the patient’s adrenergic receptor. Pet’r’s Ex. 28 at 7, 9-
10 (ECF No. 49-1).
Dr. Steinman found that Petitioner has alpha 1 adrenergic receptor antibodies. Id. at 15
(discussing Ex. 16 (ECF No. 12-2)). The presence of these antibodies had been “associated with
POTS, dysautonomia and inappropriate tachycardia, which are mainly autoimmune to adrenergic
receptors.” Id. at 6 (citing H. Li, Autoimmune Basis for Postural Tachycardia Syndrome, J. Am.
Heart Assoc. 1 (2014) (filed as Ex. 28, Ref. 12 on October 29, 2017 (ECF No. 48-3)).
Theorizing that Petitioner’s Gardasil or Hep. A vaccines triggered her antibodies, Dr. Steinman
looked at the components of the vaccines and “performed BLAST searches at the website of the
National Library of Medicine to search for relevant structural homologies.” Id. at 7-8. Dr.
Steinman “found some highly relevant molecular mimics in both the hepatitis A vaccine and in
the Gardasil vaccine.” Id. at 8. When Dr. Steinman compared the Gardasil vaccine to the alpha
1 adrenergic receptor, he found one sequence of 13 amino acids that contained 7 identical amino
acids, and another sequence of 12 amino acids that contained 6 identical amino acids. Id. at 11-
12. And when he compared the Hep. A vaccine to the alpha 1 adrenergic receptor, he found one
sequence of 10 amino acids that contained 7 identical amino acids, another sequence of 8 amino
acids that contained 5 identical amino acids, and a sequence of 9 amino acids that contained 5
identical amino acids. Id. at 13-14.15 Due to the similarities, Dr. Steinman concluded that “the
components of the Gardasil vaccine and the Hepatitis A vaccine have sufficient identity to
human adrenergic receptor” to have triggered Petitioner’s antibodies. Id. at 14-15. Dr. Steinman
opined they did so, and he believed that their existence indicated that the vaccines caused
Petitioner’s autoimmune dysautonomia with inappropriate tachycardia. Id. at 18.
15
Dr. Steinman acknowledged that the “adrenergic receptor sequences elicited by Gardasil
vaccine and by the Hepatitis A vaccine are different,” but was not concerned because due to
intramolecular epitope spreading, “once tolerance is broken to one component of an antigen the
immune response can spread to other regions of the molecule.” Pet’r’s Ex. 28 at 15 (ECF No.
49-1).
12
Dr. Steinman asserted that his theory is consistent with Petitioner’s symptoms. As he
pointed out, the rapid onset of adverse reactions, including syncope, has been reported following
Gardasil vaccination. Id. Also, Petitioner’s heart began racing “within a day of the Gardasil
vaccine,” and “15 to 16 days after the Hepatitis A vaccine,” a response Dr. Steinman found
“totally consistent with timing of adverse events reported in the package insert for Gardasil, and
from the velocity of the recall response described in the 2012 IOM report.” Id.
Dr. Steinman also contended that his theory and analysis satisfy the Althen test. Id. at 19.
He claimed causation is established by his theory of molecular mimicry, which shows that the
Gardasil and Hep. A vaccines elicited immunity to adrenergic receptors associated with
dysautonomia and inappropriate tachycardia. Id. He then observed that his theory proved the
vaccination was the reason for Petitioner’s injury by demonstrating that the Gardasil vaccine
antigens were sufficient to trigger a neuroinflammatory response when injected into Petitioner,
resulting in an immune response which triggered a post-vaccine antibody mediated attack on the
alpha 1 adrenergic receptor. Id. He also noted that a proximate temporal relationship between
vaccination and injury was fulfilled by the onset of “heart racing” in the day or days after the
Gardasil vaccine and 15 to 16 days after the Hep. A vaccine. Id.
2. Dr. MacGinnitie’s First Report
Respondent provided a competing opinion by Andrew MacGinnitie, M.D., Ph.D. See
Resp’t’s Ex. A (ECF No. 63-1). Dr. MacGinnitie is an Allergist/Immunologist who has
practiced for 16 years and is currently Attending Physician and Clinical Director for the Division
of Immunology at Boston Children’s Hospital overseeing clinical operations for
Allergy/Immunology, Rheumatology and Dermatology. Id. at 1. He is also Associate Professor
of Pediatrics at Harvard Medical School. Id. Dr. MacGinnitie found “to a reasonable degree of
medical certainty” that “it is extremely unlikely that J.S.’s symptoms are due to an immune
reaction triggered by vaccination.” Id. at 9. Dr. MacGinnitie based his conclusion on the
implausibility of Dr. Steinman’s theory of molecular mimicry. Id. at 4.
According to Dr. MacGinnitie, Dr. Steinman’s theory of molecular mimicry has
significant flaws regarding causation. First, according to Dr. MacGinnitie, Dr. Steinman’s
theory gives “too much credence to the presence of anti-adrenergic receptor antibodies, which
are frequently present in normal controls.” Id. at 4. Second, Dr. MacGinnitie believed that Dr.
Steinman “rel[ied] on an outdated view of molecular mimicry.” Id. Finally, Dr. MacGinnitie
believed that Dr. Steinman “ignore[d] data that POTS is not, in fact, an autoimmune condition
and that extensive epidemiologic data shows [sic] that Gardasil (HPV) and VAQTA (Hep A)
vaccines are not associated with autoimmunity.” Id.
a) POTS and Autoimmunity
Dr. MacGinnitie found that there is “little evidence and no consensus that
POTS/dysautonomia is an autoimmune disease.” Id. at 4. He observed that Dr. Steinman
“ignores data that POTS is not, in fact, an autoimmune condition and that extensive
epidemiologic data shows that Gardasil (HPV) and VAQTA (Hep A) vaccines are not associated
with autoimmunity.” Id. He also pointed to four studies that indicate “no relationship between
HPV or Hep A/VAQTA vaccination and autoimmune disease.” Id. at 8-9.
13
Dr. MacGinnitie admitted that Dr. Steinman cited the Li article in support of his theory
that “POTS, dysautonomia and inappropriate tachycardia, which are mainly autoimmune to
adrenergic components.” Id. at 4. However, he pointed out that the study was “small” and that
reviewers took issue with it. Id. He also observed that the study was not “a relevant model of
human disease” because it “uses a completely different methodology in which antibodies (IgG)
from patients and controls are added to a culture of rat cremaster arterioles.” Id. 5-6.
b) CellTrend Assay
Dr. MacGinnitie observed that the Loebel article indicated “serious issues” with
Petitioner’s reliance on her CellTrend assay, which showed that she has alpha 1 adrenergic
receptor antibodies. Id. at 5; see M. Loebel, Antibodies to β Adrenergic and Muscarinic
Cholinergic Receptors in Patients with Chronic Fatigue Syndrome, 52 Brain, Behavior, and
Immunity 32 (2015) (filed as Ex. A, Tab 7 on Feb. 7, 2018 (ECF No. 63-8)). Dr. MacGinnitie
himself took issue with the assay because it “is not approved by the Food and Drug
Administration (‘FDA’),” because “J.S.’s [reference] value was 7.3, barely above the cited upper
range of normal (7.0) [in the assay] and . . . a value that is frequently seen in normal controls,”
and because a “more extensive panel of autoantibodies associated with dysautonomia was
completely negative.” Resp’t’s Ex. A at 5-6 (ECF No. 63-1) (citing Ex. 18 (ECF No. 18-1)).
Not only was Petitioner’s value only slightly above the upper range, Dr. MacGinnitie
opined that because five percent of normal individuals will have values outside the normal range,
Petitioner’s value “[wa]s likely not indicative of elevated levels, but within the range of normal
variation.” Id. at 5. Dr. MacGinnitie also distinguished the Loebel article because it was limited
to patients with Chronic Fatigue Syndrome and provided no data on POTS or autonomic
dysfunction. Id.
c) Mouse Model
Dr. MacGinnitie took issue with Dr. Steinman’s reliance on the Guatam articles, which
indicated that a vaccine with a stretch of 12 amino acids where at least 5 are identical with a
patient’s adrenergic receptor would cause humans to experience a cross-reactive autoimmune
response directed to self. Id. at 6. Dr. MacGinnitie believes the references are of “at best
marginal” significance because they rely on a mouse model, and there are “multiple examples of
data in animals failing to translate into human disease.” Id. Additionally, the mouse model used
Complete Freund’s Adjuvant, “a mix of mycobacterial proteins and mineral oil” that is “so
powerful that it is not suitable for use in human use,” whereas “[w]hile Gardasil and VAQTA
use an adjuvant, it is aluminum, which is relatively weak and well tolerated.” Id. at 6-7. The
mouse model was also “of demyelination,” which is “the basis of multiple sclerosis and related
illnesses in humans” but not the basis of dysautonomia and POTS. Id. at 6.
3. Dr. Bingham’s First Report
Respondent also filed a report by Dr. Peter M. Bingham. See Resp’t’s Ex. C (ECF No.
65-1). Dr. Bingham is a Pediatric Neurologist and clinical researcher with 25 years’ post-
residency experience in general child neurology. Id. at 1. Dr. Bingham concluded that it is
“more likely than not” that Petitioner “did not suffer her symptoms . . . as a result of Gardasil
14
vaccination.” Id. at 6.16 Dr. Bingham based his theory on the lack of epidemiological evidence
associating Gardasil and POTS in the “considerable discussion in the literature, case reports,
[and] case series, regarding a potential link.” Id.
Dr. Bingham characterized Petitioner’s symptoms and positive antibody findings as
“non-specific” and that “in many cases, individuals without any neurological disease may harbor
these antibodies.” Id. at 6-8. Moreover, “[n]ot all patients with POTS harbor these antibodies.”
Id. Because not all POTS patients have the adrenergic antibodies and it is not known how many
people without POTS have the antibodies, Dr. Bingham concludes that the presence of the
antibodies does not prove that Petitioner had an autoimmune disease.
He also opined that Dr. Steinman’s opinion does not satisfy “the standards for causal
attribution set by the Institute of Medicine regarding adverse effects of medicine” because it
requires “a number of assumptions.” Id. at 6.17 For example, Dr. Bingham observed that there
was a “relatively long period of latency before induction of the autoimmune response that [Dr.
Steinman] and his colleagues elicited in mice.” Id. at 7.
Based on his review, Dr. Bingham concluded if Petitioner had POTS, it was more likely
than not that she did not develop it because of her Gardasil vaccination.
4. Dr. Steinman’s Second Report
Petitioner responded to Respondent’s experts with another report by Dr. Steinman. See
Pet’r’s Ex. 35 (ECF No. 68-1). After reading Respondent’s reports, Dr. Steinman’s “conclusions
in this matter are unchanged.” Id. at 20. Dr. Steinman acknowledged that Dr. MacGinnitie was
correct that “immunity to nervous system antigens like myelin is rather widespread in normals.”
Id. at 3. However, he reiterated that “many diseases that are adjudicated in this court do not have
a finally universally agreed mechanism of pathogenesis. Many disease entities have multiple
mechanisms of pathogenesis. The Petitioner is asked to compose a theory. I base my theory in
this case and in all others on the peer-reviewed literature.” Id. at 10. He emphasized that his role
“is not to provide a massive theory that proves how autoimmune disease is caused at a level of
certainty,” but rather “to provide a theory on how Petitioner’s disease could be caused, based on
solid peer reviewed publications.” Id. at 18. Dr. Steinman then responded to Respondent’s
reports.
a) Dr. MacGinnitie
(1) POTS and Autoimmunity
16
Dr. Bingham disagreed with Dr. Steinman that Petitioner had developed POTS because she did
not demonstrate its core symptoms, “chronic, recurrent, orthostatic intolerance.” Resp’t’s Ex. C
at 5 (ECF No. 65-1).
17
Dr. Bingham seemingly proposed that the Court rely on a test similar to the standards outlined
in the Institute of Medicine report on Adverse Effects of Vaccinations rather than the Althen test,
whose criteria he claimed are “considerably less stringent.” Resp’t’s Ex. C at 8 (ECF No. 65-1).
15
Dr. Steinman emphasized that the Li article and two supplemental reports “discuss
autoantibodies in POTS.” Id. at 10; see Ex. 18; M. Thieben, Postural Orthostatic Tachycardia
Syndrome: The Mayo Clinic Experience, 82 Mayo Clin. Proc. 308 (2007), filed as Ex. 35, Ref. 1
on Apr. 19, 2018 (ECF No. 68-2); X. Wang, Autoimmunoreactive IgGs from Patients with
Postural Orthostatic Tachycardia Syndrome, 6 Proteomics Clin. Appl. 615 (2012), filed as Ex.
35, Ref. 2 on Apr. 19, 2018 (ECF No. 68-3). Dr. Steinman observed that Dr. MacGinnitie’s
statement that Dr. Steinman “ignores data that POTS is not, in fact, an autoimmune condition
and that extensive epidemiologic data shows that Gardasil (HPV) and VAQTA (Hep A) vaccines
are not associated with autoimmunity” is contradictory because “he states that POTS is not an
autoimmune disease, and then he cites four references stating that the vaccines in Petitioner’s
theory are not associated with autoimmunity.” Pet’r’s Ex. 35 at 8 (ECF No. 68-1). Dr. Steinman
reviewed Dr. MacGinnitie’s four references and noted that they did not search for POTS
specifically, and so “in no way rule out an association between POTS and the vaccines in
question.” Id.
Dr. Steinman took issue with Dr. MacGinnitie’s portrayal of his words “POTS,
dysautonomia and inappropriate tachycardia, which are mainly autoimmune to adrenergic
components,” stating the quotation was only partial and inaccurately portrayed him as qualifying
his autoimmune theory to “all POTS patients.” Id. at 10-11. Dr. Steinman then quoted the full
passage which clarified that his opinion explained increased standing plasma norepinephrine and
excessive tachycardia in “many POTS patients.” Id. Dr. Steinman defended his use of the Li
article and claimed that it “is a valid assay to measure anti-adrenergic antibodies.” Id. at 15.
(2) CellTrend Assay
Dr. Steinman disagreed that the Loebel article indicates “serious issues” with the
CellTrend assay and requested that Respondent explain what this assertion meant. Id. at 12-14.
He then responded to Dr. MacGinnitie’s comments about the FDA by explaining that lab testing
“is not necessarily ever ‘approved by the FDA.’” Id. at 13. He responded to Dr. MacGinnitie’s
comments about Petitioner’s barely elevated antibody levels by saying “‘above the cited upper
range of normal’, means EXACTLY that.” Id. at 14. He also disagreed with Dr. MacGinnitie’s
description of Exhibit 18 as “a more extensive panel of autoantibodies,” saying “it is simply a
different panel and did NOT include anti-adrenergic antibodies.” Id. at 12.
Dr. Steinman emphasized that the negative panel of antibodies Dr. MacGinnitie referred
to, the Paraneoplastic assay, Exhibit 18, did not measure anti-adrenergic antibodies, and that
Petitioner’s CellTrend assay showed high levels of M4 antibodies. Id. at 12, 15. While Dr.
Steinman admitted that “[t]he significance of antibodies to M4 in POTS is unknown,” he
emphasized that research indicates “patients with ‘idiopathic’ orthostatic hypotension (OH) have
a strong association with activating autoantibodies.” Id.
(3) Mouse Model
Dr. Steinman responded to Dr. MacGinnitie’s critiques of the mouse model by explaining
he relied on “a standard model of autoimmune disease – EAE – to support Petitioner’s theory”
because he did not have an “animal model of autoimmune POTS.” Id. at 16. Dr. Steinman also
cited a new report where researchers caused paralysis by “passively transferr[ing] T cells that
16
cross-reacted with myelin basic protein and HPV.” Id. at 17; see R. Ufret-Vincenty, In Vivo
Survival of Viral Antigen-Specific T Cells that Induce Experimental Autoimmune
Encephalomyelitis, 188 J. Experimental Medicine 1725 (1998), filed as Ex. 35, Ref. 5 on Apr.
19, 2018 (ECF No. 68-6). The report concluded that “mimicry between a virus and myelin basic
protein can lead to clinical paralysis.” Pet’r’s Ex. 35 at 17 (ECF No. 68-1).
(4) Anti-Adrenergic Receptor Antibodies
Dr. Steinman acknowledged that Dr. MacGinnitie was correct that molecular mimicry
may be widespread in healthy normal individuals, but Steinman remained convinced that
“molecular mimicry is a key mechanism in understanding how tolerance to ‘self’ structures like
myelin proteins is broken.” Id. at 1-4, 18. Dr. Steinman reemphasized what he said in his first
report: “[o]ther genetic and environmental factors are necessary before these self-reactive
immune responses to neural antigens like adrenergic receptors might lead to an autoimmune
disease of the autonomic nervous system.” Id. at 3-4. Dr. Steinman also observed that he has
published nine publications on molecular mimicry from 1994-2016, whereas Respondent’s
experts have not published on the topic at all. Id. at 4-8.
b) Dr. Bingham
Dr. Steinman restated his belief that Petitioner does have autoimmune dysautonomia with
inappropriate tachycardia. Id. at 19. Dr. Steinman reiterated his reliance on the Althen criteria.
Id. Finally, Dr. Steinman defended the timing and latency before induction of the autoimmune
response elicited in mice, and stated that he “relied on the criteria in humans from the IOM
report on Adverse Vaccinations” that Dr. Bingham himself considered more stringent than
Althen. Id. at 20.
5. Dr. MacGinnitie’s Second Report
Respondent responded to Dr. Steinman’s second report by submitting another report by
Dr. MacGinnitie. See Resp’t’s Ex. E (ECF No. 70-1). Dr. MacGinnitie referred to “a very
recent article” that concludes “at this time there is no conclusive evidence support [sic] a causal
relationship between the human papillomavirus vaccine and POTS. Though a causal relationship
has been postulated, it is of utmost importance to recognize that while temporal associations may
be observed, conclusion of causality cannot be drawn from case reports and case studies due to
the small sample size and lack of a control population.” Id. at 4 (citing B. Butts, Human
Papillomavirus Vaccine and Postural Orthostatic Tachycardia Syndrome: A Review of Current
Literature, J. Child Neurology 1 (2017), filed as Ex. E, Tab 3 (ECF No. 70-4)). He also
responded to Dr. Steinman’s second report.
a) POTS and Autoimmunity
Dr. MacGinnitie reiterated that the studies cited by Dr. Steinman suggesting a possible
autoimmune cause of POTS were unreliable. Resp’t’s Ex. E at 2-3 (ECF No. 70-1). Dr.
MacGinnitie responded to Dr. Steinman’s criticism that his opinions are contradictory by
asserting that the premise that “POTS is not an autoimmune disease” was not inconsistent with
the premise that “vaccines in Petitioner’s theory are not associated with autoimmunity.” Id. at 2.
Dr. MacGinnitie also observed that he “could not find any report of POTS being successfully
17
treated with immunosuppressive drugs such as steroids, which are the typical therapy for
autoimmune diseases.” Id. at 3.
b) CellTrend Assay
Dr. MacGinnitie defended his comments about the FDA, explaining that lab testing
developed and performed by a single laboratory is regulated by the Centers for Medicare &
Medicaid Services (CMS) and Centers for Disease Control (CDA), which can grant certification
under the Clinical Laboratory Improvement Amendments (CLIA), but that a kit or test developed
for use at multiple laboratories comes under FDA jurisdiction. Id. at 3-4. Dr. MacGinnitie
emphasized that the CellTrend assay has neither CLIA nor FDA certification. Id. at 4. Dr.
MacGinnitie also noted that the Loebel and Li articles present “no data relating the mild
elevation of auto-adrenergic receptor antibodies in this case with POTS.” Id. at 3.
Dr. MacGinnitie admitted that Dr. Steinman is correct that the panel of autoimmune
antibodies sent by the dysautonomia specialists did not include anti-adrenergic antibodies, but
pointed out that sending this panel instead of the CellTrend assay indicated the specialists did not
find the CellTrend assay meaningful. Id. at 3. Dr. MacGinnitie observed that while Petitioner’s
CellTrend assay showed “significant levels of anti M4 antibodies,” the article Dr. Steinman cited
to demonstrates the antibodies’ relevance “does not discuss antibodies against the M4 receptor or
present evidence that these antibodies are involved in POTS.” Id. Dr. MacGinnitie found the
presence of two anti beta-cell antibodies in Petitioner irrelevant because they are not associated
with POTS and are often seen in siblings of patients with Insulin-dependent Diabetes Mellitus,
which Petitioner’s sister has. Id.
c) Mouse Model
Dr. MacGinnitie reemphasized that the reliability of the mouse model Dr. Steinman relied
on to support his theory of molecular mimicry is “at best questionable” because it “refers to
injecting non-physiologic amounts of protein plus powerful adjuvants not used in humans
(complete Freund’s adjuvant) as a model (experimental autoimmune encephalomyelitis or EAE)
for a disease (multiple sclerosis) that no one asserts JS suffers from.” Id. at 2. Similarly, Dr.
MacGinnitie found Dr. Steinman’s newly cited Ufret-Vincenty report, that EAE can be induced
by transferring T-cells between groups of mice, irrelevant, because “even if we accept his
assertions regarding cross-reactivity and molecular mimicry,” the report does not provide an
animal model of autoimmune POTS and therefore cannot establish a foundation for his theory of
molecular mimicry. Id.
d) Anti-Adrenergic Receptor Antibodies
Dr. MacGinnitie admitted that Dr. Steinman has published more on molecular mimicry,
but emphasized that Dr. Steinman “does not present any data contradicting the fact that there is
extensive overlap between viral and bacterial proteins and human ones which far exceed the
degree of homology between proteins in Gardasil and adrenergic receptors that he cites in his
original report.” Id. at 1-2. Dr. MacGinnitie emphasized that “the presence of anti-adrenergic
and anti-cholinergic antibodies is the sole evidence of autoimmunity potentially associated with
18
POTS in this case” and noted that this is a “crucial weakness” in Dr. Steinman’s opinion because
“immunity against self-antigens is common in the absence of clinical disease.” Id. at 1.
6. Dr. Brawer
Petitioner responded to Dr. MacGinnitie’s second report by filing three reports by Dr.
Arthur E. Brawer. See Pet’r’s Ex. 49 (ECF No. 92-1); Pet’r’s Ex. 60 (ECF No. 93-1); Pet’r’s Ex.
63 (ECF No. 100-1). Dr. Brawer concurred with the presence of adrenergic antibodies as one of
the grounds for satisfying the Althen test. See Pet’r’s Ex. 49 at 3 (ECF No. 92-1). However,
Petitioner “chose[] not to rely upon his expertise in presenting her case” because “Dr. Brawer did
not develop the adrenergic antibody approach any further.” Pet’r’s Mot., filed Dec. 6, 2021 at 3
(ECF No. 105).18 Because Petitioner did not rely on Dr. Brawer, the Court will not summarize
Dr. Brawer’s reports.
Respondent filed two reports in response to Dr. Brawer. See Resp’t’s Ex. F (ECF No. 99-
1) (Report by Dr. Andrew MacGinnitie, Ph.D.); Resp’t’s Ex. G (ECF No. 99-14) (Report by Dr.
Peter M. Bingham). These reports dealt with arguments made by Dr. Brawer. Because
Petitioner no longer relies on Dr. Brawer, there is no need to summarize these expert reports.
C. Chief Special Master’s Decision
On December 6, 2021, Petitioner filed a Motion for Ruling on the Record, which
included a request for a hearing. ECF No. 105. The Chief Special Master issued his Decision on
July 15, 2022, denying entitlement to compensation under the Vaccine Act and denying
Petitioner’s request for a hearing. ECF No. 109 at 26, 37 (“It is simply not the case that every
Vaccine Act Claim need be resolved by hearing—even where the [P]etitioner explicitly so
requests.”). Ultimately, the Chief Special Master found that Petitioner failed to show, “on the
basis of th[e] medical record, that she experienced any arguably vaccine-caused disease or
condition—and it is more likely her symptoms reflect somatization.” Id. at 2 (emphasis in
original). Further, the Chief Special Master emphasized that to “date, [he has] never ruled that
the HPV vaccine likely causes any form of dysautonomia. The medical science that has been
offered on this contention in case after case simply does not support that conclusion—and [he is]
aware of no counter, persuasive analyses that would suggest the alternative.” Id. at 36 (emphasis
in original). He also provided “that this particular case lacks reasonable basis going forward”
and warned that attorney’s fees would not be awarded if Petitioner “opts to extend this claim’s
life further . . . .” Id. at 36 n.41 (emphasis in original).
18
Petitioner’s reluctance to rely on Dr. Brawer may have stemmed from Dr. Brawer’s personal
attacks on Respondent’s experts. See, e.g., Pet’r’s Ex. 63 at 3 (ECF No. 100-1) (“[T]he tone of
Dr. Bingham’s report suggests that he himself may in part be suffering from a functional
neurological disorder.”). Respondent moved to strike Dr. Brawer’s second report due to this
language. See ECF No. 102. The Special Master denied the motion, but informed the Petitioner
that this sort of language was “a reason for deeming the attacking expert’s report to deserve less
weight than an even-handed report would receive.” ECF No. 104 at 2.
19
Petitioner timely filed a motion for review on August 14, 2022. ECF Nos. 112 & 114.
Petitioner’s numbered objections to the Decision are as follows:
Numbered Objection 1
The Special Master’s Decision is arbitrary, capricious, an abuse of discretion and
contrary to law in finding tachycardia cannot be deemed a primary condition
compensable by the Vaccine Program (a “cognizable vaccine injury” (Dec. at 28-29, 30-
32); see Tarsell United States, 133 Fed. Cl. 782, 794 (2017). While tachycardia might
often be accompanied by other symptoms, the Decision identified no basis for denying its
status as a primary condition or cognizable vaccine injury.
Numbered Objection 2
By prospectively denying the availability of attorneys’ fees for the present Motion for
Review, the Decision was arbitrary, capricious, an abuse of discretion and contrary to
law. (Dec. at 36, fn. 41). Where the Decision determined for the first time that the
Petition had lost reasonable basis, thus denying review or improperly burdening
Petitioner with the costs of review, the special master interjected a chilling effect thereby
undermining the Vaccine Act procedure for review and appeal established in 42 U.S.C. §
300aa-12(e), and violated judicial procedure prohibiting a judge from determining an
appeal of his or her own decision. Title 28, Section 47.
Numbered Objection 3
The special master engaged in an arbitrary pattern of result-oriented and generalized
factfinding that is unsupported by the medical record. The special master’s arbitrary
factfinding featured unfounded rejection or silent avoidance of objective medical
evidence to allow the unsupported conclusion that petitioner’s condition was a mental
disorder. The Decision was arbitrary and capricious in summarily finding petitioner’s
condition was more likely a mental disorder than a physiological disorder in the face of a
medical record that contained no straightforward evidence of a mental disorder diagnosis.
The arbitrary pattern of factfinding was manifest in the Decision’s one-sided
interpretation of petitioner’s objective testing, including the interpretation of medical
findings of tachycardia, which were central to petitioner’s case, but were cast by the
special master as psychiatric (or “mental disorder”) phenomena. (Dec. at 35).
Numbered Objection 4
The Decision is arbitrary, capricious and an abuse of discretion in its internally
contradictory finding that dysautonomia might be attributable to an autoimmune process
in rare cases such as the those in the present case, where anti-adrenergic antibodies
caused heart rate increases, while simultaneously admonishing petitioners to avoid
bringing claims involving HPV vaccination and allegations of dysautonomia. Thus, while
acknowledging that in rare cases there may be a basis to pursue an autoimmune claim in
connection with the vaccine's inducement of dysautonomia, the special master foreclosed
this avenue of evidence entirely. Thus, the Decision was arbitrary in foreclosing the
possibility that petitioner could prove the very same claim the court found potentially
plausible. (Dec. at 36).
Numbered Objection 5
20
The special master’s decision was arbitrary, capricious, and contrary to law in deeming
petitioner’s proffered medical theory of causation as insufficient. The Petitioner
demonstrated a sufficient relationship between molecular mimicry and the increase in
anti-adrenergic antibodies to satisfy Althen prong 1, contrary to the special master’s
holding (Dec. at 32).
Numbered Objection 6
The special master was arbitrary, capricious, and abused his discretion in denying an
evidentiary hearing where the issue of petitioner’s mental state and her behavior was
central to the Decision’s findings of fact. The abuse of discretion is evident where the
special master found that preponderant evidence strongly supports the conclusion that
“some other kind of mental disorder explains [petitioner’s] symptoms” based on a
medical record which reveals no clear psychiatric or psychological diagnosis of
Petitioner. Thus, the special master abused his discretion in substituting a diagnosis that
is absent from the medical record, while at the same time denying a hearing where the
Petitioner could fully develop the issue of her mental state. (Dec. at 35-36).
ECF No. 112 at 1-3. Respondent filed its response on September 14, 2022. ECF No.
118. After reviewing the filings, the Court upholds the Chief Special Master’s findings of fact
and conclusions of law and sustains the Chief Special Master’s decision.
II. DISCUSSION
A. Jurisdiction & Standard of Review
The United States Court of Federal Claims exercises jurisdiction to review vaccine
decisions pursuant to § 300aa-12(e)(1) of the Vaccine Act. In reviewing a special master’s
decision, this Court may:
(A) uphold the findings of fact and conclusions of law of the
special master and sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the
special master found to be arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law and issue its
own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further action in
accordance with the court’s direction.
42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court of Federal Claims reviews the
Chief Special Master’s decision to determine if it is ‘arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with the law.’ 42 U.S.C. § 300aa-12(e)(2)(B).” Markovich v.
Sec’y of Health & Human Servs., 477 F.3d 1353, 1355-56 (Fed. Cir.), cert. denied, 552 U.S. 816(2007).
Specifically, “[f]indings of fact of the special master are reviewed under the arbitrary and
capricious standard, conclusions of law are reviewed under the ‘not in accordance with law’
21
standard, and discretionary rulings are reviewed under the abuse of discretion standard.”
Broekelschen v. Sec’y of Health & Human Servs., 89 Fed. Cl. 336, 343 (2009), aff’d, 618 F.3d
1339 (Fed. Cir. 2010) (citations omitted). “An abuse of discretion may be found when (1) the
court’s decision is clearly unreasonable, arbitrary, or fanciful; (2) the decision is based on an
erroneous conclusion of the law; (3) the court’s findings are clearly erroneous; or (4) the record
contains no evidence upon which the court rationally could have based its decision.” Simmons v.
HHS, 875 F.3d 632, 635 (Fed. Cir. 2017) (quoting Hendler v. U.S., 985 F.2d 1364, 1380 (Fed.
Cir. 1991)). As such, the Vaccine Act “provide[s] for a limited standard for appeal from the
[special] master’s decision” and its legislative history shows “that this procedure [should not] be
used frequently, but rather in those cases in which a truly arbitrary decision has been made.”
H.R. Rep. No. 101-386, at 517 (1989) (Conf. Rep.), reprinted in 1989 U.S.C.C.A.N. 3018, 3120.
Indeed, the arbitrary and capricious standard is “well understood to be the most
deferential possible.” Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 870
(Fed. Cir. 1992). As such, when evaluating factual findings of the special master, 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—
these are all matters within the purview of the fact finder.” Porter v. Sec’y of Health & Human
Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011); see also Hodges v. Sec’y of Dept. of Health &
Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (“[O]n review, the Court of Federal Claims is
not to second guess the Special Master[’]s fact-intensive conclusions; the standard of review is
uniquely deferential for what is essentially a judicial process.”). “Rather, as long as a special
master’s finding of fact is ‘based on evidence in the record that [is] not wholly implausible, [the
Court is] compelled to uphold that finding as not being arbitrary or capricious.’” Porter, 663
F.3d at 1249 (first alteration in original and second alteration added) (quoting Cedillo v. Sec’y of
Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010)). Where “the special master has
‘considered the relevant evidence of record, drawn plausible inferences, [and stated] a rational
basis for the decision,’ reversible error is extremely difficult to establish.” Silva v. Sec’y of
Health & Human Servs., 108 Fed. Cl. 401, 405 (2012) (quoting Hines v. Sec’y of Health &
Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).
B. Vaccine Act Legal Standard
To receive compensation under the Vaccine Act, petitioner must prove either 1) that she
suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table – that
corresponds to the vaccination received, or 2) that she suffered an injury that was caused-in-fact
by a vaccine. See 42 U.S.C. §§ 300aa-13(a)(1)(A) & 300aa-11(c)(1). Here, Petitioner does not
allege, and the record does not show, that she suffered a “Table Injury” caused by the Hep. A or
HPV vaccination. See Vaccine Injury Table, 42 U.S.C. § 300aa-14. Rather, Petitioner argues
that these vaccinations caused her injury in-fact.
In Althen v. Secretary of Health & Human Services, the Federal Circuit articulated a
three-part test outlining a petitioner’s burden to establish causation-in-fact under the Vaccine
Act. 418 F.3d 1274, 1278 (Fed. Cir. 2005). To prove causation-in-fact, a petitioner must:
[S]how by preponderant evidence that the vaccination brought
about her injury by providing (1) a medical theory causally
22
connecting the vaccination and the injury; (2) a logical sequence of
cause and effect showing that the vaccination was the reason for
the injury; and (3) a showing of a proximate temporal relationship
between vaccination and injury.
Id.; see also Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1355 (Fed. Cir. 2019)
(holding that a petitioner must “prove[] all three Althen prongs by a preponderance of the
evidence”); 42 U.S.C. § 300aa–13(a)(1)(A) (Petitioner must prove causation-in-fact “by a
preponderance of the evidence.”). “A careful reading of Althen, shows that each prong . . . is
decided relative to the injury: (1) medical theory connecting the vaccination to the injury; (2)
cause and effect showing the vaccination was the reason for the injury; and (3) proximate
temporal relationship between the vaccination and the injury.” Broekelschen v. Sec’y of HHS,
618 F.3d 1339, 1346 (Fed. Cir. 2010) (citing Althen, 418 F.3d at 1278). Identifying the injury is
therefore a prerequisite to the analysis. Id.The Federal Circuit has “held that causation-in-fact in the Vaccine Act context is the
same as the ‘legal cause’ in the general torts context.” De Bazan v. Sec'y of Health & Human
Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008). “Therefore, drawing from the Restatement
(Second) of Torts, the vaccine is a cause-in-fact when it is ‘a substantial factor in bringing about
the harm.’” Id. (quoting the Restatement (Second) of Torts § 431(a)). Accordingly, to establish
causation, “[Pe]titioner must show that the vaccine was ‘not only a but-for cause of the injury but
also a substantial factor in bringing about the injury.’” Id. at 1351 (quoting Shyface v. Sec’y of
Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)). A “‘substantial factor’
standard requires a greater showing than ‘but for’ causation.” Id. (quoting Shyface, 165 F.3d at
1352). But a petitioner is not required to establish the causation to a scientific certainty:
Causation in fact under the Vaccine Act is thus based on the
circumstances of the particular case, having no hard and fast per se
scientific or medical rules. The determination of causation in fact
under the Vaccine Act involves ascertaining whether a sequence of
cause and effect is “logical” and legally probable, not medically or
scientifically certain.
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). The Vaccine
Act permits proof of causation through “the use of circumstantial evidence envisioned by the
preponderance standard.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325
(Fed. Cir. 2006) (internal citation and quotation marks omitted). Petitioner’s claim must be
“substantiated by medical records or medical opinion.” Althen, 418 F.3d at 1279.
III. DISCUSSION
Petitioner presents six numbered objections for this Court’s review. Objections 1 and 3
challenge the Chief Special Master’s finding that Petitioner failed to establish a cognizable injury
compensable under the Vaccine Act. Objection 5 challenges the Chief Special Master’s finding
that, although he need not engage in a thorough Althen analysis, Petitioner failed to meet her
burden under Althen prong 1. Objection 4 challenges the Chief Special Master’s rejection of the
scientific evidence supporting the viability of Petitioner’s theory of causation. Objection 6
23
challenges the Chief Special Master’s decision to decide the case on the record without a
hearing. Finally, Objection 2 challenges the Chief Special Master’s prospective denial of
attorney’s fees. See ECF No. 112 at 1-3.
A. The Chief Special Master’s finding that Petitioner failed to establish a
cognizable vaccine injury is neither arbitrary nor capricious.
Petitioner argues the “Special Master’s Decision is arbitrary, capricious, an abuse of
discretion and contrary to law in finding tachycardia cannot be deemed a primary condition
compensable by the Vaccine Program.” ECF No. 112 at 1 (citing ECF No. 109 at 28-29, 30-32).
Specifically, Petitioner claims “[w]hile tachycardia might often be accompanied by other
symptoms, the Decision identified no basis for denying its status as a primary condition or
cognizable vaccine injury . . . .” Id. Further, Petitioner alleges “an arbitrary pattern of result-
oriented and generalized factfinding that is unsupported by the medical record . . . [which]
featured unfounded rejection or silent avoidance of objective medical evidence to allow the
unsupported conclusion that petitioner’s condition was a mental disorder.” Id. at 2. According
to Petitioner, the “medical record . . . contained no straightforward evidence of a mental disorder
diagnosis. . . . [T]he Decision’s one-sided interpretation of petitioner’s objective testing,
including the interpretation of medical findings of tachycardia . . . w[as] cast by the special
master as psychiatric (or “mental disorder”) phenomena[,]” resulting in arbitrary factfinding. Id.
at 2 (citing ECF No. 109 at 35).
It is well established that the Vaccine Act “places the burden on the petitioner to make a
showing of at least one defined and recognized injury.” Lombardi v. Sec'y of Health & Human
Servs., 656 F.3d 1343, 1353 (Fed. Cir. 2011). Petitioner must, therefore, “show by a
preponderance of the evidence that she suffered from [a] medically recognized ‘injury,’ not
merely a symptom or manifestation of an unknown injury.” Lombardi, 656 F.3d at 1353. “If the
existence and nature of the injury itself is in dispute, it is the special master’s duty to first
determine which injury was best supported by the evidence presented in the record before
applying the Althen test to determine causation of that injury.” Id. at 1352 (citing Broekelschen,
618 F.3d at 1346). This duty “is mandated by the Vaccine Act, which creates a cause of action
for persons suffering a ‘vaccine-related injury . . . .’” Id. (citing 42 U.S.C. § 300aa-11(a)).
The Chief Special Master found that although the “medical record . . . strongly
establishes that Petitioner regularly sought medical treatment, often on an emergency basis, after
her vaccinations in 2015[,] . . . that record simply does not preponderantly establish any actual
injury that could be grounds for a Program claim.” ECF No. 109 at 28 (emphasis in original).
Respondent argues the Decision is “supported by the absence of reliable evidence pointing to a
physiological condition, such as a dysfunctional autonomic nervous system, that otherwise
persuasively explains her condition.” ECF No. 118 at 15-16. Specifically, the Chief Special
Master found Petitioner “was never legitimately diagnosed with POTS” and her “other reported
symptoms—whether characterized as ‘inappropriate tachycardia or something else [(e.g.,
dysautonomia)]—do not, individually or collectively, amount to a cognizable condition of any
kind that could be shown to be vaccine-caused.” ECF No. 109 at 29. Although Petitioner
exhibited symptoms suggestive of injury, such as increased heart rate and blood pressure levels,
no “testing evidence has been filed that would confirm the diagnosis.” Id. “At most,” the Chief
Special Master explains, “Respondent’s expert Dr. Bingham allowed the possibility that the
24
November [2015 tilt-table] testing could support POTS—but that is not the same as an admission
(consistent with the preponderant standard applicable herein) that it was likely.” Id.
Petitioner argues that “a close review of the record reveals a clear pattern of illness—
tachycardia and arrhythmia related to autonomic dysfunction.” ECF No. 114 at 23. But
Petitioner’s symptoms, as Dr. Bingham observed, “were consistently non-specific” and
“transient/intermittent19—and this is especially true of the purported ‘inappropriate
tachycardia.’” ECF No. 109 at 29. Petitioner explains that tachycardia typically applies “to a
heart rate above 100 beats per minute” and sinus tachycardia, which originates in the sinus node,
“is normal during exercise or anxiety and occurs abnormally associated with shock, hypotension,
hypoxia, congestive heart failure, fever, and various high output states.” ECF No. 114 at 1 n.1.
Such sinus tachycardia “can in some instances be inappropriate or pathologic.” Id. Therefore,
Respondent emphasizes the Chief Special Master’s finding that sinus tachycardia, in some cases,
may merely reflect a normal physiological response to stressors—such as anxiety or exercise—
and is not in each case necessarily injurious or inappropriate. See ECF No. 109 at 29. And
“while Petitioner might have displayed occasions of post-vaccination tachycardia at times in
th[e] record, it cannot be deemed to be a persistent condition that could reasonably be linked to
vaccination.” Id.; see, e.g., Pet’r’s Ex. 18 at 1-3 (ECF No. 18-1) (autonomic testing performed in
connection with tilt-table test did not identify measurable orthostatic intolerance). That
Petitioner’s physicians prescribed medication for her condition does not, by itself, “verify[] the
validity of the diagnoses of inappropriate sinus tachycardia and autonomic disorder.” ECF No.
114 at 26. Nor does the fact that Petitioner’s heart rate rose by more than 40 points during the
November 2015 tilt-table test establish a persuasive diagnosis for POTS. See Pet’r’s Ex. 18 at 1-
3 (ECF No. 18-1). In the end, the Chief Special Master weighed the record evidence of
tachycardia and this Court does not find any basis to disturb that weighing of the evidence.
Similarly, while Petitioner reported “clonic-tonic seizures” following receipt of the Hep.
A and Gardasil vaccinations, her medical records reflect diagnoses of “pseudoseizures” and
related manifestations of an underlying psychological condition. Pet’r’s Ex. 6 at 4, 38, 40-42,
80, 130-131, 134 (ECF No. 6-7); Pet’r’s Ex. 12 at 11 (ECF No. 7-4). Petitioner argues “there
was never a confirmed psychiatric diagnosis, other than ‘anxiety,’ which . . . is frequently seen in
POTS and dysautonomia[] disorders [and where] patients ‘may be incorrectly labeled as having
panic disorder or chronic anxiety.’” ECF No. 114 at 29 (citing Pet’r’s Ex. 25, Phillip Low et al.,
Postural Tachycardia Syndrome (POTS), J Cardiovasc Electrophysiol. 2009 March; 20(3): 352–
358. (“Patients with orthostatic intolerance often present with complaints of exercise intolerance,
lightheadedness, diminished concentration, tremulousness, nausea and recurrent syncope, and
may be incorrectly labeled as having panic disorder or chronic anxiety.”)). However, the Chief
Special Master described in detail repeated instances where physicians evaluated Petitioner,
expressed the opinion that her symptoms were likely psychological in nature and related to
anxiety, and failed to identify an underlying physiological condition. See ECF No. 109 at 3-6.
19
Petitioner’s argument that “[t]he Decision elevated [her] burden of proof by requiring an
unrealistic and unreachable level of proof showing continuous tachycardia” is similarly without
merit. ECF No. 114 at 23. The Chief Special Master considered the transient and intermittent
nature of Petitioner’s symptoms in light of her medical record as a whole, rather than as a
dispositive factor in rendering his Decision.
25
To be sure, “[n]o formal medical testing ever later confirmed the presence of any epileptic
etiology or factors that might cause seizure activity—and in fact the absence of such evidence
was clear not long after the relevant vaccinations.” Id. at 29; see Pet’r’s Ex. 6 at 130 (ECF No.
6-7); Pet’r’s Ex. 9 at 64-68 (ECF No. 7-1). Again, the Court will not reweigh the record
evidence.
Petitioner contends that “[t]here is nothing in the Decision that controverts the medical
record evidence showing a dysautonomia based tachycardia. A finding of arrhythmia caused by
Gardasil . . . has been validated as a ‘cognizable’ or primary vaccine injury in Court of Claims
and Office of Special Masters decisions.” ECF No. 114 at 29 (citing Tarsell v. United States,
133 Fed. Cl. 782 (2017)). However, the Special Master must “evaluate[] the utility of evidence
differently in light of all facts relevant in a specific claim,” and “a different evidentiary record
can lead to different outcomes.” Rickett v. HHS, 468 F. App’x 952, 959 (Fed. Cir. 2011). And it
is reasonable to conclude that “[b]ecause the facts of Tarsell differ widely from the facts of the
present case, a different outcome is warranted.” ECF No. 118 at 15.
In Tarsell, Petitioner developed acute disseminated encephalomyelitis within days of
receiving the tetanus-diphtheria-acellular-pertussis vaccination and suffered unexpected death
only weeks later. Tarsell, No. 10-251V, 2017 WL 4583233, at *16 (Fed. Cl. Sept. 25, 2017).
Not only did the Court find that Petitioner successfully established her claimed injury, but it also
found “preponderant evidence of a logical sequence of cause and effect,” connecting Petitioner’s
injury to her receipt of the vaccination. Id. at *16. Whether the Petitioner’s arrythmia was a
cognizable injury, based on the facts in that case, was not at issue. Conversely, here, upon
weighing the evidence in the record, the Chief Special Master found “numerous, credible
instances in which treaters proposed or surmised that Petitioner’s symptoms had a psychologic
component, reflecting either somatization, excessive anxiety, or some other mental trauma that
precipitated a heightened heart rate and other panic-like symptoms.” ECF No. 109 at 30 (citing
Pet’r’s Ex. 6 at 80 (August 21, 2018 visit with treaters finding Petitioner experienced
pseudoseizure); Pet’r’s Ex. 7 at 36 (ECF No. 6-8) (August 23, 2015 neurology consult
diagnosing Petitioner with acute anxiety disorder); Pet’r’s Ex. 9 at 47 (ECF No. 7-1) (September
22, 2015 neurology evaluation discussing recent stressors in Petitioner’s life that may have
caused seizure-like activity); Pet’r’s Ex. 13 at 213 (ECF No. 9-1) (September 19, 2015 neurology
consultation with a clinical impression of “probable pseudo-seizures”, “stress related psycho-
somatization or somatization”, and “probable anxiety associated panic”)). Accordingly, the
Chief Special Master had reasonable basis to find “[t]he possibility of a psychological factor as
causal of Petitioner’s symptoms[,] [which] also strongly negates the conclusion that Petitioner
did in fact experience something that reasonably could be seen [as] a potential vaccine injury.”
ECF No. 109 at 31.
Petitioner complains that “[i]n glossing over the persistent findings of objective evidence
over an extended time period showing tachycardia, arrhythmia, dysautonomia and autoimmunity,
in favor of a vague special master diagnosed ‘mental disorder’, the Court has engaged in an
arbitrary exercise of selective citation to the record and abused its discretion . . . .” ECF No. 114
at 30-31. To illustrate, Petitioner discusses the Chief Special Master’s discreditation of her
February 2016 CellTrend laboratory results, which showed elevated levels of adrenergic and
muscarinic antibodies. Pet’r’s Ex. 16 at 1-2 (ECF No. 12-2). Petitioner argues, because “it
cannot be determined on th[e] records that she possesse[d] these specific antibodies in the
26
immediate one to ten days after the receipt of the HPV vaccine[,]” the Decision “imposed,
without explanation or justification, a heightened burden of proof on Petitioner to show the
presence of antibodies within one to ten days of vaccination.” ECF No. 114 at 36 (citing ECF
No. 109 at 31). Further, Petitioner believes the Chief Special Master ignored the “dramatic
increase [of antibodies] over time” as evidenced by testing showing increased antibody levels in
March 2020, see Pet’r’s Ex. 37 at 1 (ECF No. 77-2), which “signifies that Petitioner experienced
an autoimmune reaction rather than a manifestation of psychiatric symptoms,” ECF No. 114 at
36. However, the Chief Special Master carefully considered and weighed this evidence and did
not find it supportive of Petitioner’s claim. To be sure, “neither [P]etitioner’s treating providers,
nor her own expert, Dr. Steinman, ever related these results to [P]etitioner’s post-vaccination
symptoms.” ECF No. 118 at 17. And, showing elevated antibodies nearly five years later does
not sufficiently establish a causal connection between Petitioner’s claimed injuries, which began
within days of her vaccination.
The Chief Special Master clearly considered Petitioner’s antibody testing between 2016
and 2020 but did not find it persuasive. According to the Decision: “I give little weight to the
testing results Petitioner obtained in 2020—almost five years after her vaccination, and nearly
four years after the case was filed—suggesting she possessed certain anti-adrenergic
autoantibodies theorized to cause dysautonomia.” ECF No. 109 at 31. The Chief Special Master
found other record evidence more compelling. For example, he assessed Petitioner’s November
2015 neurological exam, where her autoimmune antibody panel was negative, and her symptoms
were described as consistent with a panic disorder. Id. at 7-8; Pet’r’s Ex. 18 at 1-3 (ECF No. 18-
1). The Chief Special Master also acknowledged reasonable objections raised by Dr.
MacGinnitie, who questioned the legitimacy of leveraging anti-adrenergic autoantibody test
results to support a causal theory for dysautonomia. ECF No. 109 at 31 n.35. It is not for this
Court to reweigh that evidence and it will not do so. The Decision also recognized that although
Petitioner’s “infectious evaluation seemed to allow for a possible autoimmune injury, [it] more
expressly discounted dysautonomia, noting that Petitioner displayed only ‘minor orthostatic
changes which are not consistent with POTS or significant autonomic instability.’” Id. at 30
(quoting Pet’r’s Ex. 4 at 3 (ECF No. 6-5)). This did not impose a heightened standard on
Petitioner; rather, the Chief Special Master had sound footing to determine that the totality of
Petitioner’s medical record, including the temporal distance between her receipt of the
vaccination and the laboratory testing, weighed against her claim. It was therefore neither
arbitrary nor capricious for the Chief Special Master to find “no record evidence . . . that
Petitioner possessed these antibodies in the fall of 2015 . . . [and to] not add any legitimate
weight to the contention that Petitioner did in fact experience an actual injury post-vaccination.”
Id. at 31.
Finally, Petitioner argues that, after multiple visits to the emergency room where she
exhibited symptoms of tachycardia, Dr. Lefkowitz “identified a persistent pattern of tachycardia
and other autonomic symptoms, which was verified by objective testing on the date of
examination.” ECF No. 114 at 24; Pet’r’s Ex. 12 at 1, 10-11 (ECF No. 7-4) (diagnosing
Petitioner with “Shy-Drager syndrome,” symptoms consistent with “inappropriate sinus
tachycardia,” and “autonomic disfunction due to the HPV vaccine”). Specifically, Petitioner
references the Zio Patch Electrocardiography Monitoring Report reviewed by Dr. Lefkowitz,
which showed instances of premature atrial and ventricular contractions and paroxysmal atrial
tachycardia. See Pet’r’s Ex. 12 at 4 (ECF No. 7-4). However, the Chief Special Master observed
27
that “Dr. Lefkowitz not only appears to have relied heavily on Petitioner’s self-reported history
(which did not emphasize the extent to which her prior multiple ER visits never corroborated an
underlying psychologic explanation for her episodes)” but he also did not have the benefit of the
tilt-table results to include in his evaluation. ECF No. 109 at 30. More importantly, the Chief
Special Master did not ignore the record evidence; rather, after reviewing Petitioner’s
comprehensive medical history—including the objective evidence—he recognized multiple
instances of tachycardia. But he concluded that the record did not establish that Petitioner’s
episodes were pathologic in this case. Accordingly, he determined that, even if tachycardia can
be inappropriate in some cases, Petitioner failed to preponderantly establish a cognizable injury
here. He also found Dr. Lefkowitz’s assessment incomplete, and grounded, at least in part, on
Petitioner’s self-report of her own medical history, which he believed merited less weight. The
Chief Special Master acknowledged that “[w]hat one treater is told, or understands, about a
claimant’s history at a certain point in time can be incomplete, or reflect a tentative, initial
diagnostic proposal that later on is not confirmed by . . . testing or the course of the injured
party’s medical disease.”20 Id. Therefore, in weighing the totality of the evidence, it was
reasonable for the Chief Special Master to conclude that Dr. Lefkowitz’s diagnosis appeared
“speculative and . . . in any event unsubstantiated by the record.” Id.
“Clearly it is not . . . the role of this court to reweigh the factual evidence, or to assess
whether the special master correctly evaluated the evidence.” Munn, 970 F.2d at 870 n.10.
Indeed, the Court will not “examine the probative value of the evidence or the credibility of the
witnesses. These are all matters within the purview of the fact finder.” Id. The Court must
therefore review the Chief Special Master’s decision to determine whether it is reasonably based
on the evidence in the record. Milik, 822 F.3d at 1376. Here, the Chief Special Master
sufficiently considered the record evidence and articulated a reasonable basis for finding
Petitioner failed to demonstrate, by a preponderance, that she “experienced any cognizable
illness or injury that could be attributed to vaccination in any manner other than temporally (an
insufficient basis for entitlement, as well-recognized in the Program).” ECF No. 109 at 31. And
it is insufficient to merely highlight contrary evidence on review when it is the charge of the
Chief Special Master, rather than this Court, to weigh and assess its credibility. The Chief
Special Master appropriately considered the record evidence and his conclusion was not
arbitrary, capricious, or otherwise not in accordance with law.
B. The Chief Special Master’s finding that Petitioner failed to meet her burden
under Althen Prong 1 is neither arbitrary nor capricious.
Petitioner complains the Chief Special Master’s Decision “was arbitrary, capricious, and
contrary to law in deeming [her] proffered medical theory of causation as insufficient . . . [where
she] demonstrated a sufficient relationship between molecular mimicry and the increase in anti-
adrenergic antibodies to satisfy Althen prong 1 . . . .” ECF No. 112 at 2-3. If a Special Master
determines that the record evidence does not support the injury alleged, the Special Master need
20
The Chief Special Master also indicated Dr. Lefkowitz’s diagnosis of Shy-Drager syndrome
undercut his credibility, as this theory was rejected by both Parties’ experts, and largely
abandoned by Dr. Lefkowitz in later years. ECF No. 109 at 30; see, e.g., Pet’r’s Ex. 33 at 27
(ECF No. 60-1) (raising myxoma as a new diagnosis in October 2017).
28
not “undertake and answer the separate (and frequently more difficult) question whether there is
a medical theory, supported by ‘reputable medical or scientific explanation,’ by which a vaccine
can cause the kind of injury that the petitioner claims to have suffered.” Hibbard v. Sec’y of
Health & Human Servs., 698 F.3d 1355, 1365 (Fed. Cir. 2012) (quoting Althen, 418 F.3d at
1278). Indeed, absent sufficient “proof of the asserted injury, the theory of causation is a
priori unreliable and unsupported by the evidence, and it is unnecessary to go through the
remaining Althen factors.” Hughes v. Sec’y of HHS, 154 Fed. Cl. 640, 650 (2021) (citing
Broekelschen, 618 F.3d at 1346). It was reasonable for the Chief Special Master to conclude that
Petitioner failed to establish a compensable injury, and therefore a thorough Althen analysis was
not required. For completeness, however, the Chief Special Master provided an Althen prong 1
analysis.
“Under the first [Althen] prong, a petitioner must demonstrate that the vaccine at issue
can cause the injury alleged.” Greene v. Sec’y of Health & Human Servs., 146 Fed. Cl. 655, 663
(2020) (citing Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355-56 (Fed. Cir.
2006)). To make this showing, “a petitioner must provide a reputable medical or scientific
explanation that pertains specifically to the petitioner’s case, although the explanation need only
be ‘legally probable, not medically or scientifically certain.’” Broekelschen, 618 F.3d at 1345(quoting Knudsen, 35 F.3d at 548–49). “The special master or court may not make such a
finding based on the claims of a petitioner alone, unsubstantiated by medical records or by
medical opinion.” 42 U.S.C. § 300aa-13(a)(1). Petitioner argues that “Dr. Steinman has
painstakingly shown how his theories of causation, especially his molecular mimicry theory, is
based on a ‘sound and reliable medical or scientific explanation.’” ECF No. 114 at 40 (quoting
Boatmon, 941 F.3d at 1351. Specifically, Petitioner cites precedent embracing molecular
mimicry “as a reliable scientific mechanism for explaining the pathophysiology of certain
immune-mediated conditions, including many demyelinating disorders.” ECF No. 114 at 41
(quoting Morgan v. Sec’y of Health & Human Servs., No. 15-1137V, 2019 WL 7498665, at *19
(Fed. Cl. Dec. 4, 2019), review denied, decision aff’d, 148 Fed. Cl. 454 (2020).
Dr. Steinman grounded his argument on theoretical homology between the HPV vaccine
and nerve receptors, theorizing that the “HPV and Hepatitis A vaccines could elicit T cell
immunity to significant stretches of the alpha-adrenergic receptor . . . [which] can spread to other
regions of the molecule.” Pet’r’s Ex. 28 at 15 (ECF No. 49-1). However, the Chief Special
Master found “insufficient reliable corroborative proof supporting the conclusion that the
homology is meaningful from a pathogenic sense. Merely showing via BLAST searches that
some homology exists between amino acid sequences in the HPV vaccine components and nerve
cells,” he explains, “does not amount to a preponderant showing that the vaccine can produce
antibodies that will likely cross-react against those cells.” ECF No. 109 at 32. The Chief Special
Master also considered, and accepted, Dr. MacGinnitie’s opinion that, “although amino acid
sequential/component homologies are easily demonstrated in nature, . . . their presence does not
also mean concurrent cross-reactivity is inevitable.” Id. To this end, he found that Respondent’s
experts “persuasively established that the vaccines at issue were highly unlikely to cause POTS
specifically or orthostatic intolerance generally.” Id. Rather, he concluded that “the medical
records filed in this case reliably suggest that Petitioner’s symptoms were more likely
attributable to somatization or some anxiety condition, rather than an independent illness,
vaccine-caused or not.” ECF No. 109 at 34 (citing Pet’r’s Ex. 7 at 224, 226–27, 233 (ECF No.
6-8) (August 20, 2015 ER visit complaining of anxiety, hyperventilation, and a panic attack);
29
Pet’r’s Ex. 9 at 47 (ECF No. 7-1) (September 22, 2015 neurology evaluation noting the recent
stressors in petitioner’s life may have caused seizure-like activity); Pet’r’s Ex. 13 at 213 (ECF
No. 9-1) (September 19, 2015 neurology consultation stating the clinical impression is “probable
pseudo-seizures”, “stress related psycho-somatization or somatization”, and “probable anxiety
associated panic”)). Finally, he explained “[t]he contention that the HPV vaccine could be
associated with ‘clonic-tonic’ seizures or comparable movements is also thin . . . [as it is] largely
(if not wholly) . . . derived from the HPV vaccine package insert[,]21 . . . [which is not]
particularly probative evidence for injury causation . . . .” ECF No. 109 at 33.
It is well settled that the “Special Master has discretion to determine the relative weight
of evidence presented, including contemporaneous medical records and oral testimony.”
Whitfield v. Sec’y of HHS, 154 Fed. Cl. 167, 190-91 (2021) (citing Hibbard, 698 F.3d at
1368 (finding it was not arbitrary or capricious for the Special Master to weigh diagnoses of
different treating physicians against one another, including when their opinions conflict)). Here,
the Chief Special Master considered expert theories connecting the HPV vaccine and nerve
receptors, but, on multiple occasions, found this theory “wanting because (a) it was not reliably
shown that the vaccine could likely trigger the production of offending autoantibodies, or (b) the
claimant’s injury was not established to fall into the narrow category of autoimmune-driven
POTS (which is almost exclusively not an autoimmune condition.).” ECF No. 109 at 32. The
Chief Special Master weighed, and rejected, “opinion[s]22 to this end in many such cases” where
experts opined “that the HPV vaccine can result in the production of autoantibodies sufficient to
cause POTS through an autoimmune process—more often than not alleged to interfere with
certain adrenergic nerve receptors.” Id. at 31-32. He also determined, while the medical record
demonstrates post-vaccination instances of transient tachycardia, the causation “theory offered
by Petitioner was not reliably-established—and is otherwise unpersuasive.” Id. at 31.
In sum, “[u]nder the Vaccine Act, Special Masters are accorded great deference in
determining the . . . reliability of expert witnesses.” Cedillo, 617 F.3d at 1347; see Hanlon v.
Sec’y of Health & Human Servs., 191 F.3d 1344, 1349 (Fed. Cir. 1999). The Chief Special
Master exhaustively detailed the medical records, expert opinions, and medical literature, and
sufficiently articulated a rational basis for Petitioner’s failure to meet her burden under Althen
prong 1. ECF No. 109 at 32 (“[N]othing offered in this case by Petitioner or her experts provides
more recent or more reliable evidence supporting the conclusion that the HPV vaccine might
cause POTS (or any . . . autonomic-associated symptoms for that matter).”).
21
The Chief Special Master also explains that the HPV package insert is specific to syncope,
which generally occurs “close-in-time to vaccination.” ECF No. 109 at 33 (finding the 15-
minute observation recommendation on the insert “cannot reasonably be read to suggest that the
HPV vaccine is associated with a persistent risk of syncope”). According to the Decision,
however, there is no persuasive evidence of a close-in-time syncopal event. Id.22
See, e.g., Pet’r’s Ex. 23 (ECF No. 42-5) (emphasizing “that a temporal relationship between
vaccination and symptom onset does not confirm causality” and “antibody presence does not
confirm vaccine causality of symptoms”).
30
C. The Chief Special Master’s findings with respect to the viability of
Petitioner’s HPV claims are neither arbitrary nor capricious.
Petitioner contends that the Decision is internally inconsistent in “finding that
dysautonomia might be attributable to an autoimmune process in rare cases . . . while
simultaneously admonishing petitioners to avoid bringing claims involving HPV vaccination and
allegations of dysautonomia.” ECF No. 112 at 2 (citing ECF No. 109 at 36). Specifically,
Petitioner argues that the Chief Special Master “forecloses [such claims] entirely” by providing
that there is “no reasonable basis for Petitioner to pursue Review of the Entitlement Decision.”
ECF No. 114 at 38. In support, Petitioner explains that, “[i]t is reasonable to infer from the
Decision’s holding . . . that [while] proof could be developed in support of a dysautonomia
claim[,] . . . there simply has not been enough knowledge and research yet generated to support
such claims.” Id. And such a “forward-looking prohibition on new cases is inappropriate”
where “[t]he generalized state of scientific knowledge credited in the Decision . . . changes
month to month . . . .” Id.Respondent is correct that “the Chief Special Master “did not ‘foreclose’ future claims,
but rather, forewarned counsel that attorney’s fees will not be awarded ad infinitum for meritless
claims that continue to present the same causal theory that has been rejected time and time
again.” ECF No. 118 at 27. Indeed, the Decision emphasizes that Petitioner’s proposed causal
theory has been evaluated, and consistently rejected, in multiple prior instances. ECF No. 109 at
36 (“I have never ruled that the HPV vaccine likely causes any form of dysautonomia.”)
(emphasis in original); see id. at 27 (citing prior cases). Specifically, the Chief Special Master
has found that such “claims reflect merely a (literal) temporal ‘coincidence’ between vaccination
and onset—something well recognized not to support causation.” Id. at 36 (citing Grant, 956
F.2d at 1148). Further, the Chief Special Master explained that current “science suggest[s]
‘dysautonomia’ is generally not autoimmune in character, and not otherwise capable of being
vaccine induced.” Id. at 2. As such, Petitioner “conflates that Chief Special Master’s
recognition that some evidence has emerged that in very rare cases POTS may be attributable to
an autoimmune process,” although it is most commonly not considered attributable, with a
connection between the HPV vaccination and dysautonomia. ECF No. 118 at 27, 29. Therefore,
while recognizing that “medical science may someday reach more reliable conclusions about this
subject matter that would present an occasion for reconsideration of [his] conclusions, that day
has yet to come.” ECF No. 109 at 36. In other words, the Chief Special Master simply made
clear that the current science does not support Petitioner’s theory. If the science changes, there
is nothing in the Decision that precludes a successful claim.
“Congress assigned to a group of specialists, the Special Masters within the Court of
Federal Claims, the unenviable job of sorting through these painful cases and, based upon their
accumulated expertise in the field, judging the merits of the individual claims.” Hodges, 9 F.3d
at 961. The standard of review attributed to this Court, therefore, “is uniquely deferential for
what is essentially a judicial process. Our cases make clear that, on our review . . . we remain
equally deferential. That level of deference is especially apt in a case in which the medical
evidence of causation is in dispute.” Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d
1362, 1366 (Fed. Cir. 2013) (citing Hodges, 9 F.3d at 961). Accordingly, the Chief Special
Master explains that the science, in its current state, does not support the vaccine theory of
causation offered by Petitioner. ECF No. 109 at 27 (“[N]ot nearly enough is known about how
31
such an uncommon form of autoimmune-mediated POTS would occur to draw conclusions in
Program cases sufficient to meet the preponderance level of evidence.”). The Chief Special
Master has seen no such persuasive, well written decisions that reach a contrary outcome, or
which successfully establish that compensable tachycardia was vaccine-caused. Id. at 28. “At
most, tachycardia has been a secondary symptom of other cognizable injuries.” Id. And, while
not foreclosing future claims based on these theories with new science supporting them, it is not
arbitrary, capricious, or otherwise not in accordance with law for the Chief Special Master to
find such cases will lack reasonable basis until the science changes.
D. The Chief Special Master did not abuse his discretion is deciding not to hold
a hearing.
Petitioner argues the Chief Special Master “was arbitrary, capricious, and abused his
discretion in denying an evidentiary hearing” when he attributed Petitioner’s symptoms to
“‘some other kind of mental disorder[,]’” particularly where the “medical record . . . reveals no
clear psychiatric or psychological diagnosis . . . .” ECF No. 112 at 3 (“[T]he special master
abused his discretion in substituting a diagnosis . . . absent from the medical record”). In
support, Petitioner explains that “[a]n evidentiary hearing usually provides petitioner opportunity
to put on live testimony which aids the Special Master most in cases where witness credibility is
in issue or where there is a need . . . to obtain information not contained in, or not self-evident
from, the existing filings.” ECF No. 114 at 50 (quoting D’Toile v. HHS, 132 Fed. Cl. 421, 433-
34 (Fed. Cl. 2017), aff’d mem., 726 Fed. Appx. 809 (Fed. Cir. 2018)). Petitioner believes this
case warranted a hearing to allow exploration of divergent expert opinions, and in-depth
discussion of her medical condition, e.g., as related to whether she had a “mental disorder” and
whether her tachycardia was “transient.” Id. at 44. Respondent explains that, under the Vaccine
Act, Special Masters “promulgate rules that ‘include the opportunity for parties to submit
arguments and evidence on the record without requiring routine use of oral presentations, cross
examinations, or hearings.’” Kreizenbeck v. Sec’y of HHS, 945 F.3d 1362, 1365-66 (Fed. Cir.
2020) (citing 42 U.S.C. § 300aa-12(d)(2)(D)). Indeed, “[t]here is no requirement that oral
testimony be taken to resolve differences in scientific or expert opinion. Opportunity for
confrontation or cross examination is not required.” Id. at 1366 (quoting Hale v. HHS, 22 Cl. Ct.
403, 409 (Fed. Cl. 1991)).
“Special [M]asters have wide discretion in determining whether to conduct an evidentiary
hearing. Id. at 1365 (citing 42 U.S.C. § 300aa-12(d)(3)(B)(v) (providing that a special master
“may conduct such hearings as may be reasonable and necessary” (emphasis added)). This
discretion is limited in instances where the record is not comprehensive or fully developed,
creating a need for Special Masters to observe expert witnesses personally to assess their
credibility. See Murphy v. HHS, No. 90-882V, 1991 WL 71500, at *2 (Cl. Ct. Spec. Mstr. Apr.
19, 1991). Respondent argues that Petitioner failed to offer a “credible basis for concluding that
the Chief Special Master exceeded his discretionary authority in resolving this case . . . on the
record. Petitioner makes no claim that the record was not fully developed . . . but rather,
identifies a number of abstract benefits that a live hearing might provide.” ECF No. 118 at 31. I
agree. Where Petitioners are given a “full and fair” opportunity to present their case, see Hovey
v. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 400–01 (1997), Vaccine Rule 8(d) permits
Special Masters to “decide a case on the basis of written submissions without conducting an
evidentiary hearing.”
32
Here, the Chief Special Master articulated a rational basis for exercising his discretion to
decide this case on the record. Specifically, he “was able to evaluate the evidentiary strength of
[Petitioner’s] asserted injury through a close review of the medical record” and determined that
the “record overwhelmingly undermines the contention that [the HPV or Hep. A] vaccination
harmed Petitioner.” ECF No. 109 at 35. Rather, the Chief Special Master found that Petitioner
failed to establish a cognizable injury, and there existed an alternative explanation for her
symptoms. Id. He found this conclusion to be “self-evident from a careful review of the record
itself, and did not require a hearing for their complete explication.” Id. Accordingly, this Court
concludes that the Chief Special Master did not abuse his discretion by opting to resolve the case
on the record.
E. Petitioner’s prospective demand for attorney’s fees is not ripe for review.
In his Decision, the Chief Special Master provided that “counsel acts at his own risk if he
opts to extend this claim’s life further, such as through unnecessary motion for review or
additional appeals.” Id. at 36 n.41. He continued to warn that he would “not award any fees
incurred for such work (although [he was] prepared to award fees reasonably devoted to the
claim’s prosecution up to this point).” Id. Petitioner argues that “[b]y prospectively denying the
availability of attorneys’ fees . . . the special master interjected a chilling effect thereby
undermining the Vaccine Act procedure for review and appeal established in 42 U.S.C. § 300aa-
12(e), and violated judicial procedure . . . .”23 ECF No. 112 at 1-2. Indeed, 28 U.S.C. § 47provides that “[n]o judge shall hear or determine an appeal from the decision of a case or issue
tried by him.” And prospectively determining that fees will not be paid should Petitioner seek
review of his Decision effectively undermines judicial procedure. But this Court (and perhaps
the Federal Circuit) is acting the judge of Petitioner’s appeal, not the Chief Special Master.
To the extent the objection is that the Chief Special Master may not approve fees for this
Court’s (or the Circuit’s) review, that objection is not yet ripe. “The case or controversy
requirement of Article III of the United States Constitution prohibits federal courts from issuing
advisory opinions or deciding disputes that are not concrete and adverse.” Massachusetts Bay
Transp. Authority v. U.S., 21 Cl. Ct. 252, 257 (1990). “Although established under Article I, the
Claims Court traditionally has applied the case or controversy requirement unless jurisdiction
conferred by Congress demands otherwise.” Id.; see also C.W. Government Travel, Inc. v. U.S.,
46 Fed. Cl. 554, 557-58 (2000). Respondent clarifies that “[a] claim is not ripe where it rests
upon contingent future events that may not occur as anticipated, or indeed may not occur at all.”
ECF No. 118 at 21 (citing Armoring Service, Inc. v. U.S., 123 Fed. Cl. 309, 328 (2015)).
Petitioner has not submitted a request for attorney’s fees and, unless such request is
submitted and denied, this question is not ripe for review. The Chief Special Master’s comment
23
Petitioner argues that the determination this case lacks reasonable basis going forward
“deprives petitioner of counsel or, if counsel proceeds, burdens counsel with the prospect of
providing services without compensation for his or her labor, thereby obstructing the effective
prosecution of the Petition on review or appeal.” ECF No. 114 at 32. However, as previously
explained in Section C herein, I do not find the Chief Special Master’s holding with respect to
this claim’s viability—absent a change in the scientific evidence—to be arbitrary, capricious, or
otherwise not in accordance with law.
33
therefore does not impede Petitioner’s right to meaningful review and does not contravene Due
Process and Equal Protection of the law.24
IV. CONCLUSION
For the reasons stated above, the Court DENIES the Petitioner’s Motion for Review and
SUSTAINS the Chief Special Master’s decision. The Clerk is directed to enter judgment
accordingly.
IT IS SO ORDERED.
s/ Edward H. Meyers
Edward H. Meyers
Judge
24
That said, the Court does have some concern about the blanket denial of fees for review of the
Chief Special Master’s decision. Simply finding Petitioner’s experts unpersuasive is not
generally a sufficient basis to find Petitioner lacked a reasonable basis to proceed. See Heath v.
HHS, No. 08-86V, 2011 WL 4433646, at *7 (Fed. Cl. Spec. Mstr. August 25, 2011). The Court,
however, will not resolve this matter until there is a fee petition and decision by the Chief
Special Master fully explaining the denial of any portion of the fees sought for this review. To
be clear, there is nothing improper with the Chief Special Master informing counsel in future
cases that fees will not be awarded for cases brought on this theory, the only potential concern is
with cutting off the reasonable basis to seek review in this case.
34