Howard v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-878V
(to be Published)

*************************
HANNAH COMBS, *
* Special Master Corcoran
Petitioner, *
* Dated: February 15, 2018
v. *
* Entitlement Decision; Human
* Papillomavirus (“HPV”) Vaccine;
SECRETARY OF HEALTH AND * Vasovagal Syncope; Autonomic
HUMAN SERVICES, * Nervous System
*
Respondent. *
*
*************************

Andrew D. Downing, Van Cott & Talamante, Phoenix, AZ, for Petitioner.

Debra A. Begley, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION DENYING ENTITLEMENT1

On September 22, 2014, Jenny Howard filed a petition seeking compensation under the
National Vaccine Injury Compensation Program (“Vaccine Program”)2 on behalf of her minor
daughter, Hannah Combs (who become the named Petitioner after she reached the age of majority).
Ms. Combs alleges that she experienced vasovagal/reflex syncope as a result of receiving doses of
the Human Papillomavirus (“HPV”) vaccine on November 9, 2011; February 3, 2012; and
September 13, 2012.

1
This Decision will be posted on the Court of Federal Claims’s website in accordance with the E-Government Act of
2002, 44 U.S.C. § 3501 (2012)). This means that the Decision will be available to anyone with access to the
internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Decision’s inclusion
of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days
within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial
or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the
disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the
whole Decision will be available to the public. Id.
2
The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the
Act”]. Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).
 An entitlement hearing in this matter was held on August 1, 2017, in Washington, DC. For
the reasons stated below, I find that Petitioner has not established entitlement to a vaccine injury
damages award. Petitioner’s causation theory – that the HPV vaccine could damage the autonomic
nervous system - was scientifically unreliable and unpersuasive, and Petitioner was also unable to
demonstrate, based upon her medical history, that her syncope was vaccine-caused, and/or that it
occurred due to autonomic nervous system damage caused by a vaccine.

I. Factual Background

First Two HPV Vaccine Doses and Purported Initial Manifestations of Syncope

Ms. Combs received her first HPV vaccine dose on November 9, 2011, when she was
13. Her past medical history is significant for polycystic ovarian disease, hirsutism,
hypothyroidism, anxiety, and depression. Ex. 2 at 9. She also had a prior traumatic experience
that resulted in diagnoses of post-traumatic stress disorder (“PTSD”), hypervigilance, nightmares,
dissociation, suicidal thoughts, anxiety, and depression. Id. at 52; see generally Ex. 11. At the
time of her HPV immunizations, Ms. Combs was taking oral contraceptives and medication for
depression. Ex. 4 at 17. The medical records make no reference to any reaction to the first HPV
dose, although (as discussed below) Mrs. Howard has testified that Ms. Combs did begin to
experience some initial symptoms. See generally Tr. at 9-10.

On February 3, 2012, Ms. Combs received her second HPV vaccine dose. Ex. 10 at 1. As
with the first, the record is devoid of any mention of an immediate reaction to this vaccination.
Almost seven weeks later, however, on March 16, 2012, Petitioner sought medical treatment after
she fell during a hike in her backyard. Ex. 6 at 75. As the records reveal from that visit, Ms.
Combs reported that she “fell over an embankment,” and as a result was experiencing pain in her
lower back, neck, right hip, right shoulder, and right upper leg. Id. at 74. She further reported that
during the fall she “hit her head and was unable to see at first,” and she had been suffering head
pain ever since. Id. at 75.

Significantly, the medical record from this incident did not state that Ms. Combs had
fainted, or had experienced any pre-syncopal symptoms that could have caused her fall (although
the fall occurred in the time period in which, according to Mrs. Howard, Petitioner was generally
experiencing dizziness (Tr. at 13)). In addition, the location of Petitioner’s fall (her backyard) was
a hilly area with notable elevation changes, and hence a location that a person might foreseeably
fall even if she did not feel dizzy. Tr. at 50. Ms. Combs was assessed with a chest wall and cervical
strain, and a knee and leg sprain. Ex. 6 at 79.

Several months passed without a need for medical treatment. Then, on June 4, 2012,
Ms. Combs presented to the emergency room (“ER”) at the Paul B. Hall Regional Medical

2
 Center in Paintsville, Kentucky, because she was feeling faint. Ex. 6 at 54. She reported a four-
day history of headaches similar to ones she experienced in the past. Id. at 51. Specifically,
while at work that day, she claimed to have felt as though she were going to pass out, and also
experienced numbness and tingling in her legs and feet, plus shortness of breath while travelling
to the hospital. Id. at 54. Upon evaluation, Ms. Combs’s vital signs indicated a 40 beats per
minute (“bpm”) increase, and her blood pressure levels indicated systolic drop, coupled with a
diastolic increase from 52 to 80, then back to 62. Id. at 55. Ms. Combs was diagnosed with a
vasovagal reaction and discharged. Id. at 58.

Ms. Combs then visited her primary care physician, Dr. Rhonda Meadows, on June 15,
2012, at which time she reported the pre-syncopal event from earlier in the month that had
resulted in her ER visit. Ex. 4 at 15. Mrs. Howard accompanied Petitioner to the examination,
and at that time expressed the concern that Ms. Combs’s condition could be cardiac in nature.
Id. An EKG showed sinus bradycardia3, but Holter monitor4 results were normal. Id. at 16. Ms.
Combs subsequently saw Dr. Meadows four more times over the next year, but never reported
any additional syncopal or pre-syncopal episodes. Id. at 7-16.

Third Dose and Additional Symptoms

On September 13, 2012, Ms. Combs received her third HPV vaccination. Ex. 10 at 1. The
medical records reveal no reaction to the vaccine akin to what has been alleged in this case until
November 13, 2012 (two months after), when Ms. Combs went again to the ER after she fainted
at work. Ex. 6 at 28. In the course of being transported to the ER, emergency treaters noted that
Petitioner’s blood sugar was low, and therefore gave her a tube of oral glucose. Id. While in the
ER, her symptoms improved, and she was diagnosed with hypoglycemia and transferred to Cabell
Huntington Hospital (“CHH”) for further care. Id. at 23.

Ms. Combs was an inpatient at CHH for a single night. In the course of being treated, she
reported during a neurology consultation that she had been “having episodes once a week since
April/May [two to three months after the second dose] where she feels like she is going to pass
out, but hasn’t until last night.” Ex. 9 at 13. She described the episodes as “feeling dizzy, weak in
her legs and right arm,” along with shortness of breath and feeling like her heart was racing. Id. At
CHH she saw endocrinologist Dr. James Bailes, who noted that although Petitioner reported

3
Bradycardia is defined as “slowness of the heartbeat.” Dorland’s Illustrated Medical Dictionary at 245 (32nd ed.
2012) [hereinafter Dorland’s]. Sinus Bradycardia is a “slow sinus rhythm” evidenced by a heart rate of less than 60
bpm. Id. It is common in young adults and athletes, but can also indicate a possible disorder. Id.

4
A Holter monitor (named for American biophysicist Norman Jefferis Holter) is a small, wearable heart monitor used
to track heart rhythm. Holter Monitor, Mayo Clinic, https://www mayoclinic.org/tests-procedures/holter-
monitor/about/pac-20385039 (last accessed on Feb. 2, 2018). Holter monitors are traditionally used if a standard
monitor, such as an electrocardiogram, cannot capture a suspected irregular heartbeat. Id.

3
experiencing dizziness and other pre-syncopal symptoms in the past, she had never actually passed
out until November 13, 2012. Id. at 11. Dr. Bailes remarked that all of Petitioner’s symptoms
“could be explained by hypoglycemia,” and he recommended that she alter her diet. Id. at 12.

Besides Dr. Bailes, Ms. Combs also saw a cardiologist, Dr. Jack Stines, and conveyed to
him that a couple of times per week she was experiencing “symptoms of dizziness,
lightheadedness, and visual changes,” along with chest pain and heart palpitations, but that these
symptoms usually resolved on their own. Ex. 9 at 15. Dr. Stines noted that Petitioner’s EKG was
normal, and he opined that there “may be some component of vasovagal symptoms present here
as it is very common in teenagers and her story is typical,” expressing his agreement with Dr.
Bailes’s hypoglycemia diagnosis (which was officially recorded at discharge). Id. at 18, 28. She
had a normal EEG5 as well, although the physician who administered the EEG, Dr. Mary Payne,
noted that Petitioner was tachycardic and pale during the EEG, indicating possible autonomic
dysfunction. Id. at 12, 29. Petitioner was discharged with a glucose monitor and advised to check
her blood sugar when she experienced future pre-syncopal events. Id.

On December 17, 2012, Ms. Combs returned to Dr. Stines as an out-patient, reporting
continued episodes of syncope, weakness, dizziness, and lightheadedness. Ex. 3 at 1. It was noted
that Petitioner’s blood sugars remained low, at a 50-60 blood glucose level, during the episodes,
and that she was working with Dr. Bailes to modify her diet to help manage her hypoglycemia.
Id. Dr. Stines found no evidence of any heart problems, proposing instead that Petitioner’s syncope
was “explained by her hypoglycemia.” Id. at 2. Dr. Bailes also maintained the same diagnostic
opinion. Ex. 5. at 1. Ms. Combs was encouraged to increase her fluid intake, as this would help
address any vasovagal component to her episodes. Id.

Symptoms in 2013 and Beyond

The medical records are silent for almost the next six months as to Petitioner’s condition.
On June 12, 2013, however, Ms. Combs had another ER visit after fainting again while at work.
Ex. 8 at 106. She reported three episodes of syncope lasting three seconds each, as well as
symptoms consistent with what she had previously related in her prior ER visits (i.e., shortness of
breath, chest pain, and heart palpitations). Id. Petitioner also had a brief episode of shaking while
she was passed out, although her treating physicians did not deem it consistent with a seizure. Id.
at 109. Ms. Combs was diagnosed with a vasovagal syncope and discharged. Id. Then, on June
13, 2013, during a visit with Dr. Tiffany Mills, Mrs. Howard expressed the concern that Petitioner
may have been having seizures. Ex. 4 at 5. In particular, she reported witnessing an event in the
ER the day before in which Ms. Combs had “turned pale and her eyes rolled back in her head and
she began jerking her arms and legs.” Id.
5
An EEG or electroencephalogram is an instrument used to perform an encephalography. Dorland’s at 600. An
encephalography is a recording that measures electric currents in the brain by way of electrodes attached to the scalp.
Id.

4
 Dr. Mills admitted Petitioner to the University of Kentucky Hospital (“UKH”) for further
evaluation. Ex. 4 at 6. Upon admission, Ms. Combs reported having suffered between seven and
ten episodes of fainting or near-fainting since November 2012 (two months from the date of her
final HPV dose), although as previously noted there are no medical records of any such instances
from most of the first half of 2013. Ex. 7 at 62. She described the June 12, 2013, episode as having
occurred at work three hours after she ate breakfast, and that she felt “weak, started to have tunnel
vision, SOA [shortness of air], heavy chest and was gasping, before she passed out.” Id. at 62.
Mrs. Howard added that per the store manager’s report, Ms. Combs had lost consciousness three
times over a five-to-ten minute period. Id.

While at UKH, Ms. Combs had a consultation with child psychiatrist, Dr. Kimberly
Robinson, and reported that sometimes her episodes were triggered by stress and anxiety, but
that other times the symptoms occurred without an identifiable trigger. Ex. 7 at 52. Dr. Robinson
opined that “given [petitioner’s] past history of trauma and anxiety, it is likely . . . that her
syncopal episodes may be due to panic attacks with hyperventilation.” Id. at 56. Dr. Robinson
strongly recommended that petitioner restart therapy and increased her antidepressant
medication. Id. During a neurology consultation at UKH, Ms. Combs stated that taking hot
showers often triggered her episodes. Id. at 57.

Petitioner’s mother also commented to the neurologist that during one of petitioner’s
shaking episodes, petitioner was shaking so violently, it almost knocked her out of bed. Ex. 7
at 57. The neurologist wrote “jerking intense enough to take patient off bed, is concerning for
pseudoseizure vs. syncope.” Id. at 59. But following a normal EEG, the neurologist decided not
to place petitioner on anti-seizure medication. Id. In summarizing Ms. Combs’s prior history,
the neurologist noted that she had experienced “multiple episodes of classic syncope: feels hot,
gets tunnel vision, loses consciousness, if she sits down she can stop the spell from progressing
to full loss of consciousness.” Id. at 49. The discharge diagnoses included syncope and collapse,
panic attack, anxiety, and PTSD. Id. at 62-63.

The next filed medical record is from April 5, 2014, when Ms. Combs went to the ER
complaining of a panic attack. Ex. 6 at 7. She was feeling anxious, had trouble breathing, was
shaking, and her chest hurt. Id. After receiving Ativan,6 however, her symptoms resolved. Id.
at 11. The discharge diagnosis was panic disorder. Id. at 13. No medical records beyond the
spring of 2014 have been filed, although Ms. Combs alleges that she continues to “have problems
and experience more syncopal episodes at a rate of approximately once per week,” and that
generally “she still constantly feels unwell, unhealthy, and does not know exactly when one of

6
Ativan is the trademark name for Lorazepam. Dorland’s at 173. Lorazepam is used to treat anxiety disorders,
including depression. Lorazepam (Oral Route), Mayo Clinic, https://www mayoclinic.org/drugs-
supplements/lorazepam-oral-route/description/drg-20072296 (last accessed on Feb. 2, 2018).

5
 these fainting episodes will occur.” See Petitioner’s Prehearing Submission, dated Apr. 20, 2017
(ECF No. 39) at 7.

II. Witness Testimony

A. Mrs. Jenny Howard

Mrs. Howard was the only fact witness to testify in this action. See Tr. at 5-55. She
generally testified about reactions Petitioner allegedly had to her HPV doses that were not captured
in the medical record.

She recalled Ms. Combs to be very healthy and active before receiving the first dose of the
vaccine, but then experiencing an immediate reaction, although Mrs. Howard did not realize at the
time it had anything to do with the vaccine. Id. at 14-15, 27. In so testifying, she acknowledged
that her statements were inconsistent with her witness statement, which identified reactions as
beginning only after the second dose (Ex. 1 (ECF No. 6-1) at ¶ 3) – but she attempted to explain
the discrepancy, stating that she meant only that Petitioner’s dizziness or fainting began after the
second dose in February 2012. Id. at 9-11, 35. Mrs. Howard did not, however, realize the
significance of such symptoms at the time, and therefore did not seek medical treatment for her
daughter. Id. at 11-12.

Mrs. Howard was asked questions about Petitioner’s March 2012 fall in their backyard.
She described the backyard as featuring many “banks and hills” that Petitioner enjoyed climbing.
Tr. at 50. Ms. Combs fell from a “pretty steep” embankment, rolling down the hill. Id. at 50-51,
53. She acknowledged that Petitioner arrived at the hospital before her, and therefore gave an
initial history to treaters (which says nothing about dizziness as precipitating the fall). Id. at 36.
However, Mrs. Howard insisted that dizziness was the cause of the Petitioner’s fall regardless of
what the records set forth. Id. at 37-38. She added that her supplemental witness statement (Ex. 13
(ECF No. 20-1)) confirmed a discussion she had with Ms. Combs, in which Petitioner told her that
dizziness preceded the fall (although, because this instance of dizziness occurred before Petitioner
began feeling faint as often as she did later, Mrs. Howard did not realize it was related to her
daughter’s later symptoms). Id. at 38-39.7

Thereafter, Mrs. Howard stated, Ms. Combs began feeling worse and worse, such that by
the end of 2012 she was regularly missing school and no longer felt like participating in activities
she used to enjoy. Tr. at 13-14. Petitioner also began passing out after dizzy spells, with the first

7
As noted, Ms. Combs did not testify in the hearing (nor did she file a witness statement (Tr. at 33-34)), leaving only
Mrs. Howard to relate what was told to her. Although it is well understood that virtually any kind of evidence is
admissible in a Program case, and will therefore be considered by a special master in determining if an entitlement
award is appropriate, the hearsay character of what Petitioner purportedly told Mrs. Howard is self-evident. As a result,
I give such statements little evidentiary weight.

6
instance of fainting occurring while at her job at McDonalds in the summer of 2012. Tr. at 15-16.
Often the feeling that Ms. Combs was going to faint preceded, but did not always lead to, fainting.
Id. at 40-42. These episodes would occur in many different places – at Ms. Combs’s work, in the
shower, etc. Id. at 19-20. Although Petitioner was treated after her episode that summer, Mrs.
Howard acknowledged that she did not seek greater medical evaluation for her daughter at the time
(although she now wishes she had), and that nothing was identified as wrong after Ms. Combs was
treated for the June 2012 incident. Id. at 17.

Mrs. Howard represented that she was concerned by the time of the third HPV vaccine
dose (September 2012) about the possible side effects of the vaccine, based upon research she had
done on her own, but that Ms. Combs wanted to receive it because her school nurse was providing
store gift cards to individuals who completed the three-dose course. Tr. at 18. Not long thereafter,
Ms. Combs experienced her second work incident in November 2012 that resulted in her CHH
hospitalization. Id. at 20-21. From this point on, Ms. Combs became “progressively worse,” and
would usually experience some pre-syncope symptoms before actually passing out. Id. at 22-23.
It was around this time that Ms. Combs was diagnosed with vasovagal syncope – as Mrs. Howard
admitted, the most consistently-provided explanation for her symptoms (other than
hypoglycemia). Id. at 21, 46-47. Ms. Combs continues today to experience symptoms similar to
what she displayed at that time, although in Mrs. Howard’s estimation “it’s not as bad” as it was
originally. Id. at 25.

On cross examination, Mrs. Howard provided some additional details about her daughter’s
treatment and condition. She acknowledged that Ms. Combs had struggled with anxiety and other
mental health issues before receiving any of the HPV vaccine doses, although she denied hearing
from Ms. Combs or any treaters that her syncope symptoms could have been caused by such
problems. Tr. at 29, 47-48. She also noted that some treaters, as early as the November 2012
hospitalization, had proposed that Ms. Combs undergo a “tilt table” test8 often used to evaluate an
individual’s orthostatic tolerance, but it was not performed. Id. at 54-55. And she took issue with
contemporaneous medical records that did not record the extent of symptoms she now alleges Ms.
Combs experienced after her first and second HPV doses, claiming that she attempted to inform
treaters of what she had seen but that they had not recorded her statements (and were otherwise
not aware of what she witnessed firsthand at home). Id. at 31, 34, 43.

8
A tilt table test is used to evaluate syncope by measuring heart rate and blood pressure in response to the body’s
change in position. Tilt Table Test, Mayo Clinic, https://www.mayoclinic.org/tests-procedures/tilt-table-
test/about/pac-20395124 (last accessed Feb. 8, 2018). During the test, the patient begins by lying flat on a table for
around 15 minutes. Id. The table is then quickly tilted upright to change the body’s position from lying down to
standing up. Id. The table generally remains upright for 45 minutes to allow the doctor to monitor the patient’s
cardiovascular response. Id.

7
 B. Dr. Patrick Nemechek

Dr. Nemechek, Petitioner’s sole expert witness, filed two expert reports in this case and
testified at hearing. See Expert Report, dated Sept. 22, 2015, filed as Ex. 14 (ECF No. 23-1) (“First
Nemechek Rep.”); Expert Report, dated Jan. 29, 2016, filed as Ex. 73 (ECF No. 32-1) (“Second
Nemechek Rep.”); Tr. at 56-158. He provided the opinion that Ms. Combs’s syncope was the
result of autonomic damage caused by her receipt of the HPV vaccine.

In cross examination, Respondent raised threshold questions about whether Dr. Nemechek
possessed the expertise necessary to provide a reliable expert opinion in this case. Dr. Nemechek
is an osteopath (educated at the Kansas City University of Health Sciences in Kansas City,
Missouri), has never held board certification in immunology, neurology, or the sub-specialty of
the autonomic nervous system, and has no experience conducting research into some of the matters
his opinion touched upon, such as the function of cytokines in the immune system. See generally
Nemechek CV, filed as Ex. 15 (ECF No. 23-2); Tr. at 94-95, 154. He is in fact not board certified
in any particular specialty at all at the moment (although he was previously board certified in
internal medicine). Id. at 59. He also cited numerous publications in his CV, some of which he
represented dealt with immune system dysfunction. Id. at 61. In fact, close inspection of the listed
publications revealed them to largely consist of abstracts, articles he reviewed pre-publication but
for which he did not serve as a primary author, letters to the editor of journals, or items not actually
published in a peer-reviewed publication. Id. at 96-110. He maintained that he received specialized
training in the study and treatment of autonomic problems in Portugal in 2010, but could not
provide any details as to the course taken or individuals or institutions responsible for the course.
Id. at 110-12.

Instead, Dr. Nemechek relied almost wholly on his own experience in his present clinical
practice – and in particular on his efforts to treat problems attributed to autonomic dysfunction -
for his views on the neurologic and immunologic matters in contention. Tr. at 61-64, 110, 153-54.
Dr. Nemechek currently works in Arizona9, where he operates “Nemechek Autonomic Medicine,”
a medical practice aimed at treating autonomic dysfunction, which (as its website indicates) is
purported to be “present in most all chronic diseases.”10 See Tr. at 62-64. As pointed out on cross
examination, Dr. Nemechek’s website asserts that he has developed a “protocol” for reversing
brain inflammation that, in turn, can successfully treat autonomic damage. Id. at 141. The protocol

9
Before relocating to Arizona, Dr. Nemechek had practiced medicine in Kansas, where for a time he focused on
assisting individuals with weight loss. Tr. at 115-17. At some point in that prior timeframe, Dr. Nemechek received a
warning from the Food and Drug Administration regarding the adequacy of certain of his study parameters. Id. at 113-
14.
10
See Autonomic Disorders, Nemechek Autonomic Medicine, https://www nemechekconsultativemedicine.com/
disorders/ (last accessed on Feb. 2, 2018).

8
is claimed to have been effective in the treatment of Alzheimer’s disease11 and seizure thresholds,
and has also been deemed to be helpful in individuals with autism (Id. at 142) – although Dr.
Nemechek admitted that the protocol lacks reliable clinical support, and has never been the subject
of any peer-reviewed publications. Id. at 143.

Dr. Nemechek’s opinion began with an overview of the autonomic nervous system and its
relevance to Ms. Combs’s alleged vaccine injury. See generally First Nemechek Rep. at 3-4. As
Dr. Nemechek explained, the autonomic system is responsible for the “coordination and
regulation” of organ function, metabolism, and other “background” body functions that occur
without conscious intent. Id. at 3; Tr. at 66-67. One of its branches, the sympathetic nervous
system, functions as a “complete controlling mechanism” for immune system function and
inflammation. Tr. at 67. Autonomic dysfunction, or “dysautonomia,” includes orthostatic
intolerance, which he defined as the “inability to maintain proper blood pressure in your head when
you’re standing upright.” Id. at 68. Damage to the sympathetic nerve system, attributable to a lack
of “proper sympathetic inputs,” can result in this kind of dysautonomia as well as other symptoms.
Id. at 69. Dr. Nemechek made clear that his opinion is that Ms. Combs experienced autonomic
system damage as a result of the HPV vaccines, and not merely that the vaccines caused autonomic
dysfunction. Id. at 118.

One condition Dr. Nemechek deemed particularly relevant to his theory herein was
hypoglycemia, which he defined as a suboptimal blood sugar level. Tr. at 70. The autonomic
system helps regulate blood sugar levels, reacting with a variety of symptoms (e.g., sweating and
tachycardia) in the form of a “sympathetic discharge” if levels are driven too low. Id. at 71.
Accordingly, the sympathetic nervous system provides a “defense mechanism” to prevent
hypoglycemia. Id. at 71-72. Hypoglycemia can be dangerous – especially “neuroglycopenia,”
which Dr. Nemechek defined as lacking sufficient blood sugar levels in the brain to maintain
proper brain function, and which can result in a loss of consciousness. Id. at 77.

Dr. Nemechek then turned to the role a vaccine could play in causing dysautonomia. In his
view, vaccines have the capability of damaging the autonomic system, and can do so in different
ways. For example, a vaccine can induce an autoimmune reaction, by “triggering the production
of autoantibodies” that attack self structures. First Nemechek Rep. at 3; Tr. at 78. Alternatively,
cytokines (which Dr. Nemechek defined as chemicals produced by the immune system in response
to infection or injury that serve a “critical role in coordinating the body’s defensive [immune]
system”) can “surge” in production after stimulation by a vaccine, thereby causing injury. First
Nemechek Rep. at 7; Tr. at 78. Such an overproduction of cytokines could thereafter become
chronic, when microglia – non-neuronal glial cells in the brain that also play an immune defense

11
Alzheimer’s disease is categorized as a progressive central neurodegenerative disorder. Dorland’s at 528. The first
signs of Alzheimer’s disease include slight memory loss and personality changes, but these typically progress into
profound dementia in five to ten years. Id.

9
role – are primed to become an excess source of cytokine production, often as a result of some
prior insult (e.g., stress or a concussion). Tr. at 78, 140-41.

The receipt of multiple doses of HPV vaccines, Dr. Nemechek maintained, could amount
to an “immunological concussion” sufficient to prime such microglia. Once an individual had
microglia primed to produce cytokines, recovery from the initial insult would be thwarted,
resulting in “continual leakage of cytokines in the brain,” and a “growing level of . . . sympathetic
damage.” Tr. at 90-91. Thus, the ongoing primed microglia would encourage “persistent
inflammation” in the brain, worsening with each subsequent dose of HPV vaccine, until after the
third, when hypoglycemia could result from a person’s now-damaged autonomic nervous system,
resulting in syncope. Id. at 92-93. A “pattern of increasing symptomology” with each HPV dose
would, Dr. Nemechek opined, stand as strong evidence that microglial priming was in fact
occurring. Id. at 157.

To support his contention that “the development of cumulative brain injury from a vaccine-
induced inflammatory insult is now a proven fact” (Second Nemechek Rep. at 2), Dr. Nemechek
cited a single article, C. Cunningham, Microglia and Neurodegeneration: The Role of Systemic
Inflammation, 61 Glia 71 (2013), filed as Ex. 74 (ECF No. 32-2) (“Cunningham”). Tr. at 84.
Cunningham is a review article that (through reference to other studies) considers how “systemic
inflammation negatively impacts on chronic neurodegenerative disease,” such as Alzheimer’s
disease, Parkinson’s disease, or amyotrophic lateral sclerosis. Cunningham at 72, 78. It does not
discuss how a vaccine might prime microglia, however, to produce cytokines in a chronic fashion.
Dr. Nemechek also referenced case reports involving the disease rheumatoid arthritis, and a drug
that helped patients improve their autonomic function by blocking a particular cytokine, in order
to corroborate the argument that cytokine overproduction could be pathologic. Tr. at 79.

Dr. Nemechek acknowledged that he could point to no literature that would establish how
a vaccine would initiate a chronic cytokine production process capable of causing injury akin to
what Petitioner has experienced. Tr. at 154. Nevertheless, he did attempt to offer some literature
involving the HPV vaccine that he maintained supported the conclusion that the HPV vaccine had
the potential to cause “changes reflective of abnormal function” in the autonomic nervous system.
Id. at 130. In particular, he relied on an article discussing 40 instances of reported neurologic
symptoms in Japanese girls who received the HPV vaccine between mid-2013 and the first quarter
of 2014. Tr. at 148; T. Kinoshita et al., Peripheral Sympathetic Nerve Dysfunction in Adolescent
Japanese Girls Following Immunization with the Human Papillomavirus Vaccine, 53 Intern. Med
2185 (2014), filed as Ex. 22 (ECF No. 24-7) (“Kinoshita”). Of the 40 subjects in Kinoshita, eight
met diagnostic criteria for orthostatic intolerance, while four met the clinical standard for postural
orthostatic tachycardia syndrome (“POTS”). Kinoshita at 2193, 2198. On cross examination,
however, Dr. Nemechek admitted that (in addition to involving disorders that Petitioner did not
have) the association Kinoshita proposed between the HPV vaccine and injuries involving the

10
sympathetic nerve system, like POTS, has been called into question. Tr. at 131-32.12

Dr. Nemechek similarly cited an article co-authored by Dr. Mark Geier (D. Geier and M.
Geier, A Case-Control Study of Quadrivalent Human Papillomavirus Vaccine-Associated
Autoimmune Adverse Events, 34 Clin. Rheumatology 1225 (2015), filed as Ex. 46 (ECF No. 27-
1)) – an individual whose qualifications to provide expert testimony in Vaccine Program cases
have been consistently rejected in numerous published decisions. Tr. at 134-36; see also King v.
Sec’y of Health & Human Servs., No. 03-584V, 2010 WL 5470787, at *10 (Fed. Cl. Spec. Mstr.
Dec. 13, 2010) (“[i]n many cases, stretching over many years, special masters or judges of this
court have offered negative comments on the credibility, credentials, honesty, or other aspects of
the testimony or opinions of Dr. Mark Geier”).

Relying upon the above, Dr. Nemechek reviewed Ms. Combs’s record to illustrate how his
theory applied to her circumstances. He asserted that there was nothing in her record before the
first HPV vaccination to suggest she suffered from any form of orthostatic intolerance or syncope
(thereby allowing the inference that the vaccine was a factor in its subsequent development). Tr.
at 82. He deemed Mrs. Howard’s testimony of worsening after the second HPV dose significant,
since that evidenced recurrent microglial priming due to additional exposure to the vaccine,
producing injury that could not heal. Id. at 84. He also pointed to Petitioner’s June 2012 orthostatic
test results, which (among other things) revealed heart palpitations significant enough in rate
increase from sitting to standing to be considered abnormal – and even evidence of POTS. Id. at
87 (referencing Ex. 6 at 55). Tachycardia could, he proposed, establish that Ms. Combs had
experienced underlying autonomic harm. Tr. at 92. And he emphasized that Ms. Combs’s
purported “polycystic ovarian syndrome” (PCOS)13 was understood to precipitate insulin
regulation problems that could contribute to hypoglycemia. Id. at 76.

Dr. Nemechek’s theory did not embrace the diagnosis of vasovagal syncope that
Petitioner’s physicians reached after treating her, and he expressly denied it could explain her
symptoms. Tr. at 124. He agreed that an individual could experience vasovagal syncope without

12
Respondent’s expert, Dr. Low, specifically took issue with Kinoshita as supporting a connection between HPV and
autonomic conditions like POTS, stating that subsequent evaluation of its data by European medical institutions
revealed that the supposed correlation between vaccination and the onset of such injuries could be attributed more to
the age of onset of the subjects rather than time of vaccination, and that the incidence rates of such conditions were
no different than what would be expected for all girls in the relevant age groups – thereby suggesting that any increase
was merely a statistical artifact attributable to “overreporting” rather than establishing a significant and reliable
association. Tr. at 210-11.

13
Polycystic Ovarian Syndrome is a hormonal disorder common in young women of reproductive age, causing the
ovaries to develop small fluid-filled follicles. Symptoms include irregular periods, excess androgen (male hormone),
and polycystic ovaries. The cause is unknown, but long-term complications can include type 2 diabetes and heart
disease. Polycystic Ovary Syndrome (PCOS), Mayo Clinic, https://www.mayoclinic.org/diseases-
conditions/pcos/symptoms-causes/syc-20353439 (last accessed on Feb. 2, 2018). Ms. Combs’s medical records
suggest that she was diagnosed with PCOS in early September 2012. Ex. 2 at 7-8.

11
also suffering from autonomic damage, although he also maintained that such damage could cause
it as well. Tr. at 125-26 (citing E. Lambert et al., Sympathetic Dysfunction in Vasovagal Syncope
and the Postural Orthostatic Tachycardia Syndrome, 5 Frontier in Physiology 1 (2014), filed as
Ex 75 (ECF No. 32-3)). Indeed, Dr. Nemechek acknowledged that there were many possible
causes for vasovagal syncope apart from damage to the autonomic system. Tr. at 127-29.

Dr. Nemechek also opined that the timeframe in which Ms. Combs developed syncope was
medically acceptable. He attributed some of her overall course (in which she allegedly began
exhibiting pre-syncope symptoms in March 2012, a month after the second HPV dose, but then
experienced them in an up-down pattern over the next several months) to the “unique feature of
this microglia priming phenomenon,” which became self-perpetuating as chronic cytokine
production began. Tr. at 81-82. But Ms. Combs may reasonably have not realized at first that her
earliest symptoms (for example, the purported dizziness that resulted in her March 2012 fall) were
serious. Id. at 144. Ultimately, he generally referenced Cunningham as supporting the
reasonableness of the timeframe, stating it could possibly support the initiation of neurologic
damage beginning as soon as a week after vaccination. Id. at 145-47.

On cross-examination, Dr. Nemechek acknowledged reliability problems with the part of
his theory that identified microglial activation as a source of Petitioner’s alleged autonomic
damage. He agreed that there was no test that existed to establish microglial activation was
occurring at all, and that Petitioner’s treaters had never performed any testing that might indirectly
or directly confirm this. Tr. at 137-38, 156. He also admitted to holding the belief that a wide
variety of instigating factors that individuals regularly encounter could just as likely cause
microglial activation as a vaccine. For example, a diet deficient in omega-3 fatty acids14 could
result in such activation, and could also be treated with a diet including a different kind of oil that,
while not capable of reversing activation, could at least be “protective” against the purported
inflammation that the activation purportedly encourages. Tr. at 139.

Dr. Nemechek was also unable to deny that his theory had larger deficiencies. Thus, he
could not specifically identify where in Petitioner’s body the alleged sympathetic damage being
caused as a result of the HPV vaccine was occurring (although a charitable reading of his theory
would place it as initiating in the brain). Tr. at 126-27. He could point to no independent,
corroborative evidence that Ms. Combs’s symptoms were the product of cytokine overproduction,
such as inflammation. Id. at 158. He also noted the circularity of his theory, which relied on
objective evidence of orthostatic intolerance (for example, the blood pressure and pulse readings
taken for Ms. Combs in June 2012) to establish the autonomic damage he was alleging to have

14
Omega-3 fatty acids are a category of fats necessary for body cells to properly function. The most common (and
crucial) omega-3 fatty acids are eicosapentaenoic (EPA) and docosahexaenoic (DHA). Omega-3 fatty acids are
typically found in oily fish, such as salmon, tuna, and trout. What Are Omega-3 Fatty Acids From Fish Oil?, Mayo
Clinic, https://www.mayoclinic.org/what-are-omega-3-fatty-acids-from-fish-oil/art-20232583 (last accessed Feb. 2,
2018).

12
occurred – even though he simultaneously admitted that such orthostatic results could be obtained
for a person with a functioning, undamaged autonomic nervous system. Tr. at 119-20, 122. And
he allowed that, although his theory seemed to propose that hypoglycemia in the brain explained
most of Ms. Combs’s syncopal events, she had not been consistently shown to be hypoglycemic
in each episode. Tr. at 123.

C. Dr. Phillip Low

Dr. Low offered a single expert report in this case and testified at the hearing. See Expert
Report, dated Dec. 16, 2015, filed as Ex. A (ECF No. 31-1).

In contrast to the many reasonable points raised by Respondent about the credentials of
Petitioner’s expert, Dr. Low’s background and medical/scientific qualifications were significantly
more impressive and trustworthy. See generally Tr. at 160-72. Dr. Low received his medical and
research doctorate degrees from the University of Sydney in Sydney, Australia. See Low CV, filed
as Ex. B (ECF No. 31-10) (“Low CV”). Following graduation, Dr. Low completed a fellowship in
internal medicine with the Royal Australian College of Physicians. Tr. at 161. Currently, Dr. Low
serves as a Professor of Neurology at the Mayo Clinic Medical School. Low CV at 4.

During his time with the Mayo Clinic, Dr. Low has served in various departmental and
academic capacities, including Director of the Neuroscience Laboratory, Director of the
Autonomic Reflex Laboratory, and Chairman of the Division of Clinical Neurophysiology. Low
CV at 3-4. At Mayo, he founded the autonomic reflex lab, which focuses on the clinical aspects of
the nerve micro-environment (including the blood nerve barrier, nerve oxygenation, glucose, and
endoneurial fluid pressure and contents). Tr. at 164. Dr. Low has co-authored over 400 items of
literature in the field of autoimmunity, including the largest series of publications centered on
antibody-mediated autoimmune neuropathies. Id. at 170-71; see also Low CV at 10-51. Dr. Low
has also published on the role of cytokine autonomic issues. Tr. at 171. He has served on the
editorial boards of multiple journals centered on autonomic and nervous system research, including
the Journal of Clinical Neurophysiology. Low CV at 5. He also consistently serves as a research
advisor to postdoctoral fellows at the Mayo Clinic Medical School. Id. at 7-9.

Over the past forty years, Dr. Low’s time has been divided evenly between patient practice
and research. Tr. at 167. During his clinical practice (focused on autonomic disorders), Dr. Low
estimated, he sees thirty patients per week in a supervisory role and five patients on a more
intensive basis. Id. He has diagnosed “thousands” of patients with autonomic disorders and
autoimmune neuropathies. Id. at 167-68. Dr. Low also stated that he has treated patients with reflex
syncope. Id. at 168. Dr. Low was thus amply qualified to provide expert testimony in this case

13
useful to its resolution.15

Like Dr. Nemechek, Dr. Low began his testimony with an overview of some of the medical
terms and concepts relevant herein. Dr. Low deemed the autonomic nervous system
“neurovegetative,” meaning that it “functions in the background” of the central nervous system.
Tr. at 172-73. He took pains to distinguish between autonomic failure and dysfunction, deeming
the former attributable to some serious structural nerve system failure. Id. at 173-74. Dr. Low
acknowledged that diseases can cause autonomic damage – but in such cases the damage would
be testable and corroborated by multiple pieces of evidence of symptomology. Id. at 243-44. He
cited autonomic neuropathy, such as a neuropathy caused by diabetes, as an example of such a
disease capable of harming the autonomic system. Id. at 174, 245. When a person has a diabetic
neuropathy, she will often experience a wide variety of concurrent symptoms affecting many
disparate organ systems, such as hypotension, bladder dysfunction, erectile dysfunction, and
gastroparesis.16 Very often, the disease causing autonomic failure will predate the symptoms
resulting from autonomic damage. Id. at 245. Testing exists to measure whether the autonomic
nervous system has been damaged, and to pinpoint the structures at issue. Id. at 176-77.

Autonomic dysfunction, by contrast, is inherently less serious. It can simply reflect a
normal or expected autonomic reaction (for example, feeling dizzy or faint after missing a meal)
that is not indicative of greater autonomic failure. Tr. at 178, 227. As a result, Dr. Low views the
term “dysautonomia” to be a “terrible” and imprecise term to describe autonomic problems that
cannot be attributed to identifiable autonomic failure. Id. at 173.

Dr. Low also discussed several kinds of autonomic dysfunction relevant to the claim herein.
In his understanding, orthostatic intolerance (meaning in essence that a person feels different when
she stands up) can be caused by many different things, but is not necessarily indicative of
autonomic failure, and in fact can exist without such failure. Tr. at 176, 215-16. Dr. Low deemed
reflex syncope a “type” of orthostatic intolerance commonly presenting in a person’s teen years.
Id.at 181-82. It is characterized by sudden blood pressure drops due to “a switching off of the

15
I acknowledge that Dr. Low has less overall experience and background in immunology than autonomic-related
matters – although Dr. Nemechek’s expertise in immunology is no better (if not substantially worse). But since the
Petitioner bears the burden of proof in this case, the fact that neither expert has the kind of credentials to opine on
immunologic topics that I would prefer in other cases cuts only against Petitioner and not Respondent. See Dean v.
Sec’y of Health & Human Servs., No. 13-808, 2017 WL 2926605, at *15-16 (Fed. Cl. Spec. Mstr. June 9, 2017).
16
Gastroparesis is a condition characterized by “delayed gastric emptying,” thus causing digestive interference. See
Morgan v. Sec’y of Health & Human Servs., No. 12-77V, 2017 WL 6893079, at *10 (Fed. Cl. Spec. Mstr. Dec. 6,
2017). The condition affects the normal movement of muscles in the stomach, resulting in slower motility and
difficulty emptying the stomach. Symptoms can include nausea, vomiting, digestive problems, and nutrition problems.
Gastroparesis, Mayo Clinic, https://www mayoclinic.org/diseases-conditions/gastroparesis/symptoms-causes/syc-
20355787 (last accessed on Feb. 2, 2018).

14
sympathetic efferents,”17 often triggered by a sympathetic surge. Id. at 177, 213. Hypoglycemia
can also trigger a sympathetic surge resulting in syncope, but is not itself evidence of structural
damage to the autonomic system, especially given how reversible it is (as eating can readily raise
blood sugar levels). Id. at 178-80. By contrast, neuroglycemia (reduced glucose in the brain) is a
slowly-developing process, and is characterized by extreme symptoms, like coma, that result from
exceedingly low blood sugar levels not comparable to hypoglycemia, which can be abrupt. Id. at
181.

Dr. Low offered the opinion that Petitioner’s symptoms were best characterized as
reflex/vasovagal syncope (the etiology of which is unknown), with no evidence in the medical
record of true damage to the autonomic nervous system. Tr. at 172, 205, 221, 244. Referencing the
consensus statement on the recognized clinical features of syncope (Ex. G), Dr. Low opined that
Ms. Combs’s presentation included them, such as the abrupt, “premonitory symptoms” of
orthostatic intolerance and the short duration of episodes in which she was unconscious. Tr. at 185.
Her frequently slow relative heart rate was further corroboration of the accuracy of the syncope
diagnosis. Id. at 183. In fact, the symptoms she experienced reflected a strong sympathetic
response, and hence refuted Dr. Nemechek’s conclusion that her autonomic system had been
damaged. Id. at 184 (having studied “thousands of patients with syncope” in part “to sort out who
has autonomic failure and who has not,” evidence of strong autonomic reactions makes one “darn
sure” that “the sympathetic is intact”), 223. And her overall pattern of syncope events was not
evidence to Dr. Low of autonomic nervous system injury. Id. at 218.

To support his opinion, Dr. Low engaged in a detailed walkthrough of Ms. Combs’s
medical records. He deemed the symptoms reported from her June 2012 syncopal event to
constitute “compelling” evidence of “prominent sympathetic activity.” Tr. at 186, 236. He
particularly took note of her blood pressure readings, which showed a modest systolic drop,
coupled with a “dramatic increase” in diastolic pressure, attributing this to “intense
vasoconstriction” and therefore proof of a functioning sympathetic nerve system. Id. at 18718 At
that time, her glucose levels were also normal, discounting hypoglycemia as a cause. Id. at 188.
The November 2012 records were consistent, although Dr. Low acknowledged they did reveal
moderate hypoglycemia (although he noted this could have been a transient occurrence and not
evidence, as Petitioner argues, of a chronic condition originating in the brain). Id. at 189, 191.
17
A sympathetic efferent is a motor nerve that carries impulses from the central nervous system toward the periphery.
Dorland’s at 1252.
18
Systolic pressure is produced by the systole, or contraction of the heart by which blood is forced into the aorta.
Dorland’s at 1865. Diastolic pressure is produced during the heart’s dilation period, or interval between the second
and first heart sounds. Id.at 511. The American Heart Association defines systolic pressures as the amount of pressure
your blood exerts against the artery wall when the heart beats. Diastolic pressure, in turn, is defined as the amount of
pressure exerted against the artery wall when the heart is resting between beats. Understanding Blood Pressure
Readings, Am. Heart. Assoc., http://www heart.org/HEARTORG/Conditions/HighBloodPressure/
Know/Your/Numbers/Understanding-Blood-Pressure-Readings_UCM_301764_Article.jsp#.WnzIV2eWyUk (last
accessed Feb. 8, 2018).

15
 Dr. Low commented extensively on the records generated during Ms. Combs’s November
2012 hospital stay. The CHH neurologic consult she obtained at this time revealed a history
provided to treaters that Dr. Low deemed a “nice description of sympathetic activation,” rather
than evidence of autonomic structural damage. Tr. at 190. He similarly characterized the notation
that during her EEG, Ms. Combs was pale, hyperventilating, and displaying an increased heart rate
(see Ex. 9 at 12) as proof of a functional “sympathetic burst.” Id. at 191-92. The cardiology consult
she received (Ex. 9 at 15) was also consistent with reflex syncope, while not reflecting a dangerous
hypoglycemic reaction, which would entail far more “frightening” symptoms (very low glucose
readings, a comatose patient, etc.). Id. at 193. He thus found the cardiologist’s diagnosis (vasovagal
syncope) accurate, along with his treatment advice that she increase fluid intake and avoid caffeine.
Id. at 194. Dr. Low pointed out other record instances from this time period which were consistent
with his interpretation of the proper diagnosis. Id. at 196-97, discussing Ex. 9 at 148-49.

Records from treatment Ms. Combs received in 2013 were in Dr. Low’s view also
reflective of a person suffering from reflex syncope rather than autonomic damage. As the June
2013 records demonstrated, Petitioner’s pre-syncopal feelings of lightheadedness constituted the
“gray area” before syncope that Dr. Low understands to be indicative of a healthy rather than
damaged autonomic system. Tr. at 199. Her June 12, 2013 orthostatic readings (Ex. 8 at 130)
showed a heart rate increase but normal blood pressure – evidencing some tachycardia but not
enough to find that her sympathetic system was injured. Tr. at 200. Dr. Low was also asked to
compare orthostatic readings taken three separate times between June 2012 and June 2013. Tr. at
202-03, referencing Ex. 6 at 55, Ex. 9 at 149, and Ex. 8 at 130. He noted that the tachycardia levels
were “all over the place,” with some normal and some not, suggesting to him that the “trigger” for
syncope was less likely caused by structural harm to the autonomic nervous system than by
differences in Ms. Combs’s management of factors within her control. Tr. at 203. He reiterated his
earlier point that true autonomic failure would not be evidenced, as here, by increases in diastolic
pressure. Id.

In commenting on the medical records, Dr. Low proposed several alternative explanations
for Ms. Combs’s syncope. Deconditioning, or the physiological response to decreased activity, is
a “powerful trigger” for syncope caused by sympathetic overactivity, and Dr. Low found evidence
of deconditioning in aspects of the record. See, e.g., Tr. at 195 (citing Ex. 9 at 43), 218-19. He also
identified stress and anxiety as plausible explanations. Id. at 202 (citing Ex. 7 at 52). Even an
instance in which Ms. Combs reported syncopal symptoms after a hot shower provided a credible
explanation, because the heat from the water could cause vasodilation leading to a blood pressure
decrease. Id. at 200-01 And Dr. Low placed all of the above in the overall context of Petitioner’s
age, noting that a young person might in fact experience symptoms like those complained of in
this case and not even meet the actual clinical criteria for syncope at all. Id. at 204.

16
 Dr. Low did not find Petitioner’s causation theory persuasive. As he noted, that theory was
heavily dependent on the finding that Ms. Combs’s syncope was the product of autoimmune
damage to the autonomic nervous system, resulting in hypoglycemia-instigated losses of
consciousness – a theory that in his view “doesn’t make any sense.” Tr. at 205-06. In so opining,
he emphasized the overall lack of correlation in the medical records of hypoglycemia of the
severity necessary to produce a loss of consciousness. Id. at 205. Indeed, Dr. Low observed
instances in which the Petitioner experienced syncopal events without any evidence of preceding
hypoglycemia. Id. at 228. Had low glucose been the cause of her syncope, Dr. Low would also
have expected evidence of neurologic deficits or seizure19 – all absent in Ms. Combs’s case. Id. at
228.

Besides criticizing the extent to which Petitioner’s theory did not match the record, Dr.
Low contested Dr. Nemechek’s assertion that a component mechanism of her injury was
attributable to microglial activation resulting in chronic cytokine production. He noted that he has
in fact been studying an uncommon disease involving microglial activation, and hence has first-
hand awareness of the concept. Tr. at 206-07. But in his experience, except in rare circumstances
microglial activation was more commonly a transient rather than chronic occurrence. Id. Dr. Low
was unaware of any research or literature supporting the contention that a vaccine can cause
microglial activation sufficient to harm the autonomic nervous system via cytokine production,20
and he characterized the embracing of such an argument as reflecting a “lack of understanding of
an important part of the nervous system.” Id. at 207. When asked whether Cunningham supported
this component of Petitioner’s theory, Dr. Low demurred, pointing out that the article addressed
known, extremely serious neurodegenerative disorders, like Alzheimer’s, with a “clear hypothesis
about the mechanism of microglial activation,” whereas here there was no evidence of a
“progressive process,” just repeated occurrences of syncope. Id. at 208, 246-47.

Dr. Low also disputed the reliability of theorizing that the HPV vaccine could instigate
syncopal symptoms akin to what Ms. Combs experienced via an autoimmune process caused by
the mechanism of molecular mimicry. In so doing, he took issue with the contention that POTS
stood as an example of an autoimmune-caused kind of orthostatic intolerance. Tr. at 209-10. He
termed such a theory “loose thinking,” and referenced an item of literature filed by Petitioner that

19
Dr. Low acknowledged an instance from the medical records in which it appeared that Petitioner had displayed
reported abnormal movements in connection with a loss of consciousness, but dismissed its significance, observing
that true seizure activity for Ms. Combs had not been confirmed on an EEG, and that in any event “normal people can
have syncopal episodes and have a few jerks” without it being deemed proof of a seizure. Tr. at 229.
20
Dr. Low was also dismissive of the component of Petitioner’s theory relying on cytokines as mediators of autonomic
damage, noting that in his view “there’s a lot of nonsense spoken about cytokines” based on a lack of “meaningful”
data about the role they actually play in an autoimmune process, especially since cytokines are released by the body
in response to wide variety of stimuli. Tr. at 171; see also 247-48 (characterizing theories dependent on cytokines as
causing aberrant immunologic responses as “very loose,” and “something that’s often evoked when you don’t get a
better explanation” from a comprehensive look at a disease process).

17
Dr. Low had actually co-authored, M. Thieben, et al., Postural Orthostatic Tachycardia
Syndrome: The Mayo Clinic Experience, 82 Mayo Clin. Proc., 308 (2007), filed as Ex. 71 (ECF
No. 29-6) (“Thieben”). As Thieben indicated, Dr. Low’s own research at the Mayo Clinic had
initially identified an antibody that arguably was evidence of an autoimmune basis for POTS
(Thieben at 311-12), but Dr. Low’s group had subsequently determined that there was “no
correlation” with autonomic injury and the identified antibody, leading the Mayo researchers to
recommend that others not test for the antibody since to do so was a “waste of time and effort.”
Tr. at 210; see also Tr. at 249 (after looking at “many more cases,” and “the association between
antibody titer and the course of illness,” no association was found to suggest POTS was
autoimmune in nature).

On cross examination, Dr. Low was asked about the evidence in the record suggesting that
Petitioner’s symptoms had worsened in correlation to the HPV doses she received over time, but
maintained that this did not reflect “challenge/re-challenge”21 evidence that subsequent doses were
causing swifter and more severe reactions. Tr. at 224. For re-challenge to be evident, Dr. Low
maintained, there would need to be “highly specific” proof of a heightened and more robust
immune response, such as biomarkers understood to be associated with the vaccine at issue. Id. He
would also have expected to see proof of progressive damage to Ms. Combs’s autonomic system,
when no such evidence was seen at all in this record. Id. at 225-26. Dr. Low also denied that the
vasovagal/reflex syncope diagnosis was undercut by record instances in which the Petitioner’s
heart rate raced rather than was slow, agreeing that a low rate was more consistent with the
diagnosis, but that an increased rate was also consistent with sympathetic overactivity (which
precedes syncope), and that such readings did not otherwise suggest to him the diagnosis was
incorrect. Id. at 230-32.

III. Procedural History

As stated above, this case was initiated in September 2014. After several months of medical
records gathering and filing, Respondent filed his Rule 4(c) Report in April 2015 (ECF No. 17),
recommending against an entitlement award. In September 2015, Ms. Combs filed Dr.
Nemechek’s first expert report and numerous items of medical literature in support, and in
response Dr. Low’s report was filed by Respondent in December of that same year. Petitioner filed
a rebuttal report from Dr. Nemechek in January 2016, and then (after the parties determined that
settlement was not possible), August 1, 2017 was agreed to as the date for the entitlement hearing

21
Challenge/re-challenge is “a paradigm for exploring whether one substance caused an adverse reaction. Under this
model, an individual who has had an adverse reaction to an initial vaccine dose (the challenge event) suffers a
worsening of symptoms after a second or third injection (the re-challenge event.)” Viscontini v. Sec’y of Health &
Human Servs., No. 98-619V, 2011 WL 5842577, at *22 (Fed. Cl. Spec. Mstr. Oct. 21, 2011) (quoting Doe/70 v. Sec’y
of Health & Human Servs., 95 Fed. Cl. 598, 603 (2010) (quotations omitted)), mot. for review den’d, 103 Fed. Cl. 600
(2012).

18
in this matter. The hearing went forward as scheduled, and the parties did not request the
opportunity to file post-hearing briefs. The matter is ripe for adjudication.

IV. Applicable Legal Standards

A. Petitioner’s Overall Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table –
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).22
In this case, Petitioner does not assert a Table claim.

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344,
1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1)
a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause

22
Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121,
124 (2003), aff’d 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-
159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

19
and effect showing that the vaccination was the reason for the injury; and (3) a showing of
proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory
must only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of
Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility . . . in many cases may be
enough to satisfy Althen prong one” (emphasis in original)), vacated on other grounds, 844 F.3d
1363 (Fed. Cir. 2017). But this does not negate or reduce a petitioner’s ultimate burden to establish
his overall entitlement to damages by preponderant evidence. W.C. v. Sec’y of Health & Human
Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).23

The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

23
Although decisions like Contreras suggest that the burden of proof required to satisfy the first Althen prong is less
stringent than the other two, there is ample contrary authority for the more straightforward proposition that when
considering the first prong, the same preponderance standard used overall is also applied when evaluating if a reliable
and plausible causal theory has been established. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339,
1350 (Fed. Cir. 2010).

20
 However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing . . . that mandates that the testimony of a treating physician is sacrosanct – that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record – including conflicting opinions
among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011)
(not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions
against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Dept. of Health &
Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.
for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed.
Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for
what is a medically acceptable timeframe must also coincide with the theory of how the relevant
vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of
Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl.
353 (2012), aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human
Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review
den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law Governing Analysis of Fact Evidence

The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,
condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then

21
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the
events in question that was given at a later date, provided that such determination is evidenced by
a rational determination).

Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health &
Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is
based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people
honestly report their health problems to those professionals; and (iii) medical professionals record
what they are told or observe when examining their patients in as accurate a manner as possible,
so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez
v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.
Apr. 10, 2013); Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993
F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to
accurately report the onset of their daughter’s symptoms.”).

Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical
records are generally found to be deserving of greater evidentiary weight than oral testimony –
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,
968 F.2d 1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United
States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that
oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).

However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon
common sense and experience, this rule should not be treated as an absolute and must yield where
the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19
(“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than

22
those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human
Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human
Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In
determining the accuracy and completeness of medical records, the Court of Federal Claims has
listed four possible explanations for inconsistencies between contemporaneously created medical
records and later testimony: (1) a person’s failure to recount to the medical professional everything
that happened during the relevant time period; (2) the medical professional’s failure to document
everything reported to her or him; (3) a person’s faulty recollection of the events when presenting
testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v.
Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir.
2014). In making a determination regarding whether to afford greater weight to contemporaneous
medical records or other evidence, such as testimony at hearing, there must be evidence that this
decision was the result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Human Servs., 219 F.3d
1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to
the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339
(Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir.
1999). “The Daubert factors for analyzing the reliability of testimony are: (1) whether a theory or
technique can be (and has been) tested; (2) whether the theory or technique has been subjected to
peer review and publication; (3) whether there is a known or potential rate of error and whether
there are standards for controlling the error; and (4) whether the theory or technique enjoys general
acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316 n.2 (citing Daubert,
509 U.S. at 592-95).

The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial for a (such as the district courts). Daubert factors are usually
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health

23
& Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742-45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 91997)); see also Isaac v. Sec’y of Health &
Human Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot.
for review den’d, 108 Fed. Cl. 743 (2013), aff’d, 540 Fed. App’x 999 (Fed. Cir. 2013) (citing
Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony,
based on a particular expert’s credibility, is part of the overall reliability analysis to which special
masters must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325-26
(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);
see also Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this
court has unambiguously explained that special masters are expected to consider the credibility of
expert witnesses in evaluating petitions for compensation under the Vaccine Act”).

D. Consideration of Medical Literature

Both parties filed medical and scientific literature in this case, with Petitioner for her part
filing approximately 65 separate items. But not every filed item factors into the outcome of this
decision. While I have reviewed all of the medical literature submitted in this case, I discuss only
those articles that are most relevant to my determination and/or are central to Petitioner’s case –
just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec’y
of Health & Human Servs., No. 2015-5072, 2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016)
(“[w]e generally presume that a special master considered the relevant record evidence even
though he does not explicitly reference such evidence in his decision”) (citation omitted); see also
Paterek v. Sec’y of Health & Human Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“[f]inding
certain information not relevant does not lead to – and likely undermines – the conclusion that it
was not considered”).

24
 ANALYSIS

I. Althen Prong One

The reliability of Petitioner’s causation theory is immediately called into question in light
of Respondent’s effective cross examination regarding Dr. Nemechek’s qualifications and
expertise. Dr. Nemechek has a demonstrated interest in autonomic damage and the relationship
between the autonomic nervous system and other illnesses, and appears to have attempted to
develop that interest through personal study, but he has been persuasively shown by Respondent
to lack a trustworthy grounding in such topics, whether in terms of his training or clinical expertise.
His voicing of opinions in this case does not automatically entitle them to credence, as it is well
understood in the Program that I am not obligated to accept an expert’s opinion ipse dixit, but may
weigh the expert’s credentials and competence in evaluating it as part of the first Althen prong
analysis. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997); see also Madariaga v. Sec’y of
Health & Human Servs., No. 02-1237V, 2015 WL 6160215, at *7 (Fed. Cl. Spec. Mstr. Sept. 26,
2015). Overall, the basis for Dr. Nemechek’s expertise on autonomic matters was never established
by Petitioner.

Nevertheless – Petitioner has also offered numerous pieces of medical and scientific
literature to support the causation theory Dr. Nemechek advanced, and has also attempted to
articulate that theory elsewhere, such as in her prehearing filing. See Petitioner’ Pre-hearing
Submission, dated Apr. 20, 2017 (ECF No. 39) (“Petitioner’s Pre-hearing Submission”) at 10-12.
Sufficient evidence has therefore been offered to review whether that theory stands on its own
based on the “more likely than not” evidentiary test, even if the expert tasked with providing it
was unpersuasive. See Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed.
Cir. 2009).

Petitioner maintains that her syncopal condition was caused by damage to the sympathetic
branch of the autonomic nervous system, which was in turn the product of a neuroglycemia
stimulated by the HPV vaccine doses she received over time. See Petitioner’s Pre-hearing
Submission at 14-15. She offered little in the way of direct evidence associating the vaccine, or
any other, to her injury (although it is axiomatic in the Program that direct proof need not be offered
to prevail),24 but what she did offer is not particularly compelling. Kinoshita, for example, involved

24
Although I am not bound by the decisions of other special masters, even to the extent they involve the same vaccine
and injury, I note that those few written decisions involving the HPV vaccine and injuries comparable to what Ms.
Combs alleges herein do not favor her theory. See, e.g., L.A.M. v. Sec’y of Health & Human Servs., No. 11-852V,
2017 WL 527576 (Fed. Cl. Spec. Mstr. Jan. 31, 2017) (HPV vaccine not found to cause POTS); Turkupolis v. Sec’y
of Health & Human Servs., No. 10-351V, 2014 WL 2872215 (Fed. Cl. Spec. Mstr. May 30, 2014) (HPV vaccine not
shown to cause neurocardiogenic syncope). By contrast, in one of the only decisions I have found involving HPV
vaccine and syncope, an entitlement finding was premised on Respondent’s concession that “the immediate temporal
association between [the petitioner’s] receipt of the Gardasil vaccine and her syncopal episode was medically

25
a very limited number of case studies (which in turn also involved disorders distinguishable from
the present circumstances, such as POTS). See R.V. v. Sec’y of Health & Human Servs., No. 11-
504V, 2016 WL 3882519, at *41 (Fed. Cl. Spec. Mstr. Feb. 19, 2016) (“individual patient case
reports . . . are not, in general, strong evidence of causation”) (internal quotation marks omitted),
mot. for rev. denied, 127 Fed. Cl. 136 (2016). Kinoshita’s findings were also persuasively rebutted
by Respondent’s expert as not subsequently corroborated. Tr. at 184, 205-06, 218.

Beyond the above, Petitioner could not substantiate her theory with even indirectly-
relevant reliable scientific or medical evidence. Her centerpiece argument about microglial
activation leading to chronic hypoglycemia was particularly unpersuasive. As Dr. Low noted, such
arguments were especially thin and loose, and required the application of literature like
Cunningham, which involved severe neurodegenerative diseases having no bearing on the present
circumstances, while also assuming a chronic, pathologic impact of cytokines that has not been
demonstrated to be possible after the HPV vaccine, or to be causal of repeated syncopal episodes.
Such evidence simply did not establish a reliable, plausible theory for how any vaccine, let alone
the HPV vaccine, might encourage chronic hypoglycemia sufficient to result in ongoing syncope.

II. Althen Prong Two

Even if I had found that Petitioner’s theory had sufficient evidentiary heft to support an
Althen prong one determination in her favor, the medical record does not allow for the conclusion
that the HPV vaccine more likely than not “did cause” Petitioner’s syncope. There is no record
evidence that Ms. Combs was experiencing any kind of reaction to any of the doses of HPV vaccine
she received, in the form of proof of ongoing inflammation or some test result that would permit
an inference of an existing process (for example, proof of the chronic cytokine production that Dr.
Nemechek opined was connected to Petitioner’s alleged microglial activation). Mrs. Howard’s
claim that her daughter’s dizziness preceded her fall in March 2012 was unsupported by the
medical record (which made no mention of dizziness as precipitating the fall) as well as the
circumstances of the accident, which were consistent with the location of the occurrence. See Tr.
at 49-53.

In addition, no treaters ever proposed that any HPV dose Petitioner received had anything
to do with her condition. Tr. at 241. Other than the temporal association between Petitioner’s
episodes and her vaccinations, nothing in the record would reasonably link one to the other. There
is no discernible pattern of reaction from Petitioner’s first dose of the HPV vaccine to the last, nor
evidence that reactions to subsequent doses were more powerful than earlier ones, thereby
undermining the conclusion that Petitioner experienced a “re-challenge” reaction. And as Dr. Low
pointed out, Petitioner’s argument that “symptoms” worsened after the second or third dose was

appropriate.” Vanscoy v. Sec’y of Health & Human Servs., No. 13-266V, 2013 WL 3871008, at *1 (Fed. Cl. Spec.
Mstr. July 3, 2013) (emphasis added).

26
less durable evidence of re-challenge than test results establishing a greater number of relevant
biomarkers. Tr. at 224. Otherwise there was absolutely no proof offered that Petitioner’s
autonomic nervous system was damaged; Petitioner largely relied upon evidence of her syncopal
spells to establish such damage.25

In contrast to the inadequate quality of Dr. Nemechek’s opinion, Dr. Low provided a
thorough and persuasive interpretation of the medical record that strongly supports the conclusion
that Petitioner’s syncope was vasovagal in nature, as her treaters proposed. His counterintuitive
argument that in fact Ms. Combs’s presentation was consistent with a healthy autonomic system,
rather than evidence of the contrary, was particularly compelling. Dr. Low’s impressive
background in the study of autonomic matters gave his opinion significant ballast. He not only was
amply qualified to testify on the subjects of the autonomic system and what constitutes damage to
it, but is in fact one of the foremost such authorities in the entire U.S. It was entirely reasonable to
place considerable weight on the pronouncements of such an expert.

I am mindful that it is not the special master’s function to propose what the proper diagnosis
for an individual is. See Andreu, 569 F.3d at 1382 (quoting Knudsen, 35 F.3d at 549). However, I
am called upon to determine what diagnosis the evidence best supports. In this case, that evidence
far better supports the conclusion that Ms. Combs suffered from vasovagal syncope of an unknown
etiology, as her treaters seem to have concluded, rather than due in any respect to autonomic
damage caused by the HPV vaccine.

III. Althen Prong Three

Because Petitioner’s causation theory was so unpersuasive and unreliable, I do not need to
evaluate the reasonableness of her arguments about the timeframe in which her syncope began.
See, e.g., Lasnetski v. Sec’y of Health & Human Servs., 128 Fed. Cl. 242, 264 (2016), aff’d, 696
F. App’x 497 (Fed. Cir. 2017) (not error for special master to forego Althen analysis after
determining that a petitioner had not in fact experienced the disease or illness alleged to have been
vaccine-caused). I will observe, however, that in support of this Althen prong, Petitioner can point
to little more than the fact that she experienced her “episodes” after the vaccine’s administration –
a temporal relationship which is widely understood in the Program to be insufficient evidence for
a causation determination. See, e.g., Morris v. Sec’y of Health & Human Servs., No. 13-601V,
2017 WL 2461226 (Fed. Cl. Spec. Mstr. May 9, 2017). Moreover, and as noted above, Ms. Combs
took longer to experience another syncopal episode after the third dose of HPV vaccine than the
second, undercutting the conclusion that her immune system was primed to react to it. Petitioner

25
In other cases, I have noted the circular quality of arguments that proof of a symptom or reaction is evidence in
support of Petitioner’s causation theory at work. See, e.g., Morris v. Sec’y of Health & Human Servs., No. 13-601V,
2017 WL 2461226, at *14-15 (Fed. Cl. Spec. Mstr. May 9, 2017). If a causation theory cannot be corroborated by
some indirect evidence, it cannot be enough to point to the claimant’s injury to substantiate the theory.

27
did not otherwise establish that the symptoms she experienced post-vaccination occurred in a
medically appropriate timeframe.26

CONCLUSION

The record does not support Petitioner’s contention that the HPV vaccine caused her to
develop syncope, and the expert support offered for her claim was deficient. Petitioner has
therefore not established entitlement to a damages award, and I must DISMISS her claim.

In the absence of a timely-filed motion for review (see Appendix B to the Rules of the Court),
the Clerk shall enter judgment in accordance with this decision.27

IT IS SO ORDERED.

/s/ Brian H. Corcoran
Brian H. Corcoran
Special Master

26
For comparison purposes, there is some utility in considering what a Table-based syncope injury claim looks like
in terms of onset. Every Table claim based on post-vaccination syncope requires establishing that the syncope began
within an hour of receipt of the relevant vaccine. See, e.g., §100.3(I)(D) and (II)(D). Even in those rare non-Table
circumstances where a claimant has succeeded on such a claim, onset has been found to have begun soon after
vaccination - not the month to two-month period at issue (arguably) in this case. See, e.g., Vanscoy, 2013 WL 3871008,
at *1.
27
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.

28