Johnson v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-254V
(to be Published)

*****************************
KAILEY JOHNSON, *
*
* Special Master Corcoran
Petitioner, *
* Dated: March 23, 2018
v. *
* Entitlement Decision; Human
* Papillomavirus (“HPV”) Vaccine;
SECRETARY OF HEALTH AND * Postural Orthostatic Intolerance
HUMAN SERVICES, * Syndrome (“POTS”); Chronic
* Fatigue Syndrome.
Respondent. *
*
*****************************

Sean F. Greenwood, The Greenwood Law Firm, Houston, TX, for Petitioner.

Ilene C. Albala, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION1

On March 31, 2014, Charmaine Johnson filed a petition seeking compensation under the
National Vaccine Injury Compensation Program (“Vaccine Program”)2 on behalf of her then-
minor daughter, Kailey Johnson, now the named petitioner.3 Ms. Johnson alleges that she suffers
from a variety of injuries, including leg pain, joint pain, difficulty breathing, eye drooping, and

1
This Decision has been designated “to be published,” which means I am directing it to 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). 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).

3
The caption was changed after Ms. Johnson turned 18.
fatigue, and/or postural orthostatic tachycardia syndrome (“POTS”), as a result of receiving the
third dose of the human papillomavirus (“HPV”) vaccine on February 16, 2011.

An entitlement hearing was held in the case on October 3 and 12, 2017. Now, having
considered the record, the parties’ filings, and the testimony from the hearing, I find that Petitioner
has not successfully carried her burden of proof. As discussed in more detail below, assuming the
HPV vaccine could cause POTS or any of her other claimed injuries, onset of any symptoms that
arguably might be related to POTS occurred far too long after the relevant vaccine administration
date to find the temporal gap medically appropriate. Petitioner otherwise did not successfully
establish that the HPV vaccine could cause POTS or any similar symptoms of orthostatic
intolerance.

I. Factual Background

Vaccination and Doctor’s Visits in 2011

Ms. Johnson received her third dose of HPV vaccine on February 16, 2011, when she was
11. Ex. 2 at 44. Approximately six weeks later (with no intervening medical records memorializing
any response or reaction to this vaccination), Petitioner saw Dr. Robert Gilbert, D.O., on March
29, 2011, for a cough, but complained of no other symptoms (and specifically denied dyspnea
(shortness of breath). Ex. 3 at 26-29. A lung exam was normal, and her throat and sinuses were
red. Petitioner was diagnosed with a viral upper respiratory infection, and prescribed an oral
antibiotic. Id. at 26.

On May 19, 2011 – now three months after receiving the HPV vaccine, and seven weeks
from the aforementioned March visit – Petitioner returned to Dr. Gilbert complaining of two days
of a worsening, productive cough, along with chest pain. Ex. 3 at 20-23. A chest X-ray indicated
a right lower lung infiltrate. Id. at 23. “Change of seasons” was identified as a trigger – suggesting
that allergies were suspected as a cause. Id. at 20. Her exam was otherwise normal, making no
mention of shortness of breath or fatigue, and she was diagnosed with acute bronchitis and (as with
her March 2011 visit) treated with antibiotics. Id. at 22.

The next month, on June 11, 2011, Ms. Johnson returned to Dr. Gilbert. Ex. 3 at 14-18.
She now (and for the first time in the medical records relevant to this claim) reported shortness of

2
breath “on exertion.” Id. at 14. The description of Petitioner’s onset of symptoms is somewhat
confused in this record. Thus, the record suggests her shortness of breath began only three days
before – but also states that it was “gradual,” and followed a respiratory infection from five weeks
before (most likely the May 2011 bronchitis diagnosis). Id. However, Petitioner also described her
shortness of breath as mild and intermittent, and denied feeling lightheaded. Id. An exam,
including a lung exam, was normal. Id. at 17. The assessment was a resolving upper respiratory
infection that would be monitored going forward. Id. at 16-17.

Three months passed before Ms. Johnson returned to a physician. On September 11, 2011,
she went back to see Dr. Gilbert. Ex. 3 at 8-11. She again reported experiencing mild occasions of
shortness of breath beginning two days before. Id. at 8. However, Petitioner also complained of a
sore throat, and testing revealed she was positive for strep throat. Id. at 9, 11. A chest X-ray showed
haziness in her right lower lung, but a chest CT scan performed two days later, on September 13,
2011, was negative for any acute or active problem. Ex. 3 at 6. Ms. Johnson received an antibiotic
prescription for her strep throat. Id. at 10-11. There are no additional medical records for the
remainder of 2011 suggesting that these symptoms were ongoing or progressive.

2012 and More Severe Symptoms

On March 27, 2012 (now a year since Petitioner’s receipt of the final dose of HPV vaccine),
Ms. Johnson again visited Dr. Gilbert, complaining of a sore throat for one week and also a
headache. Ex. 3 at 1. She was diagnosed with a viral infection, pharyngitis, and headache. Testing
for strep throat and mononucleosis was negative. Id. at 3-4. This record makes no reference to
shortness of breath or lightheadedness, and it does not allude to any of Petitioner’s various visits to
Dr. Gilbert in 2011, or the symptoms described at those visits.

Almost five weeks later, however, Petitioner experienced a new symptom distinct from what
she had previously reported to her medical providers. Ms. Johnson saw Diane Dietlein, M.D., at
Children’s Hospital of Alabama in Pinson, Alabama, on May 4, 2012, complaining of worsening
headaches over the prior two weeks which could be alleviated with over-the-counter pain
medication but did not completely resolve. Ex. 2 at 38-39. In particular, the record from this visit
stated that Petitioner reported a history of normal sinus headaches, but had recently experienced
two weeks of more severe pain – particularly located in her right eye, with her eyelid drooping, or

3
ptsosis (although Petitioner denied experiencing any resulting visual changes). Id. at 38. Dr.
Dietlein’s exam of Ms. Johnson was notable for mild ptosis of the right eye. A head CT was
ordered (in part to rule out a tumor), and Petitioner was referred to an ophthalmologist. Id. at 41.
That scan, however, was largely deemed normal, and detected no intracranial masses or ongoing
inflammation. Id. at 30-31.

Ms. Johnson went to ophthalmologist Dr. Martin Cogen on May 14, 2012, at the Callahan
Eye Foundation Hospital in Birmingham, Alabama, for an evaluation of her overall vision. Ex. 8
at 8. Dr. Cogen recommended that Petitioner be screened for myasthenia gravis 4, given the
constellation of symptoms she complained of, and referred her to a neuro-ophthalmologist, Dr.
Michael Vaphiades. Id. at 7. By the time Petitioner saw Dr. Vaphiades on May 25, 2012, she was
experiencing worsened symptoms, including fatigue, more shortness of breath (particularly after
exertion), and pain. Id. at 1-3. Dr. Vaphiades confirmed with an exam that Ms. Johnson’s eyes
were healthy and her vision normal, and indicated that she had not tested positive for any
antibodies associated with myasthenia gravis, but nevertheless noted that (in part because the
Johnsons were about to move from Alabama to Texas) the consensus between the Johnson family
and the relevant treaters was for Petitioner to be admitted to Children’s Hospital ER in Birmingham
in order to fully rule out myasthenia gravis. Id. at 2.

Ms. Johnson was thereafter admitted as an inpatient on May 25, 2012, and discharged the
next day. Ex. 2 at 10-11, 18-23. According to the history obtained by neurologist Leon Dure, M.D.,
Petitioner had been experiencing daily headaches in her right eye for approximately six weeks, or
since early April. Id. at 6. She also felt sickly overall and tired. A brain MRI performed at that
time, however, was normal, except for a small cyst-appearing area that was thought to be
incidental. Id. at 25-27. After consideration of all of the above, Dr. Dure could only confirm
Petitioner’s ptosis, and noted that he deemed this an “unusual presentation for myasthenia,” but
that it could nevertheless be associated with a cerebral aneurysm (although the MRI results tended
to make that unlikely as well). Id. at 9.

4
Myasthenia gravis is a disorder of neuromuscular transmission marked by fluctuating weakness and fatigue of certain
voluntary muscles, including those innervated by brainstem motor nuclei. Dorland’s Illustrated Medical Dictionary
1214 (32nd ed. 2012) [hereinafter Dorland’s].

4
 Upon discharge, Dr. Dure referred Ms. Johnson to another neurologist in order to fully rule
out myasthenia gravis by performing a “Jolly test.”5 Ex. 2 at 10. Neurologist Pierre Fequiere, M.D.,
subsequently performed EMG/NCV studies on Petitioner’s right ulnar, facial and accessory nerves
on May 29, 2012. Id. at 1-2. The NCV studies were normal, and an EMG of the right upper
extremity and face was also normal. Id. It does not appear thereafter that any of Ms. Johnson’s
treaters again raised the possibility that her symptoms reflected myasthenia gravis or anything else
so severe.

Five months later, Ms. Johnson was seen by Majorie Quarles, M.D., of Texas Children’s
Pediatrics in Conroe, Texas, on November 2, 2012, complaining of ongoing difficulties breathing
that were not effectively remedied by asthma medication. Ex. 4 at 107.6 The record notes that
Petitioner’s shortness of breath had been “off and on” for two years (a period of time which, if
literally true, would place onset of her symptoms before she received the vaccination at issue in
February 2011) but had worsened, along with episodes of chest pain that felt like intense heartburn.
Id. Dr. Quarles did not propose an etiology for Petitioner’s shortness of breath, but wrote that “there
is likely an exercise-induced asthma component since we have seen some improvement in that
respect.” Id. at 108. A few weeks later, on November 26, 2012, Petitioner saw a different
pediatrician at the same location, Dr. Richard Calvin, complaining of a cough and sore throat –
but not the shortness of breath she had reported to Dr. Quarles. Id. at 104. Petitioner’s chest exam
was clear, and she was diagnosed with a cough, cough-equivalent asthma, and pharyngitis. Id. at
105.

Treatment in 2013

Over the next two years, Petitioner saw a number of treaters in an effort to address
symptoms similar to those addressed above, but explanations for her condition were elusive. Thus,
on January 11, 2013, Ms. Johnson saw pulmonologist Michelle Mann, M.D., complaining of
exercise intolerance. Ex. 4 at 100-02. Her exam was mostly normal (and in particular denied

5
A Jolly test refers to “a sequence of repetitive nerve stimulation (RNS) studies specifically designed to look for
neuromuscular junction disease” and is helpful in diagnosing myasthenia gravis. Myasthenia Gravis, Yale Sch. of
Med., https://medicine.yale.edu/neurology/patients/neuromuscular/mg.aspx (last accessed on Mar. 6, 2018).

6
This record references an earlier treatment visit complaining of shortness of breath to the same provider the month
before, but the relevant document substantiating the earlier visit does not appear to have been filed.

5
dyspnea), and was diagnosed with asthma. Ex. 4 at 102. Dr. Mann also indicated that “work up
this far most suggestive of weakness as cause of exercise intolerance and shortness of breath given
abnormal pulmonary mechanics. Unclear etiology of weakness.” Id. (emphasis added).

The following month, Petitioner was hospitalized for pneumonia on February 7, 2013, at
the pediatric intensive care unit at Texas Children’s Hospital. Ex. 4 at 83, 94-99. According to
an attending physician’s note, Ms. Johnson was admitted for acute respiratory disease, decrease
in size of meals, drooling, dry cough, and change in quality of voice that was concerning for
evolving bulbar weakness and decreased strength. Id. at 88. A history given to Petitioner’s
emergency providers stated that she had been well until April 2011, when she developed
pneumonia and was treated with antibiotics. She recovered slowly over the next four to six
months but never returned to baseline. Id. at 84. The history also emphasized the extent to which
Petitioner’s unexplained weakness and shortness of breath was associated with physical
activity, and the fact that she had lost ten pounds over the prior four months. Id. During the
hospitalization, she received oxygen and antibiotics and was later discharged February 12, 2013.
Id. at 74-77. Neurologist Amitha Ananth, M.D., consulted and recommended additional testing,
noting the concern from 2012 for myasthenia gravis. Id. at 82.

Two weeks after this hospitalization, Petitioner saw neurologist Garrett Burris, M.D.,
on February 25, 2013. Ex. 4 at 69-73. The history Dr. Burris received again placed onset of
Petitioner’s symptoms as the spring of 2011, and emphasized her ongoing shortness of breath,
weakness, and now “dizziness when she stands up.” Id. at 70. Dr. Burris’s examination,
however, revealed “close to normal, if not normal, strength and reflexes,” although he also
noted the possibility that her episodes of weakness and dizziness had a “postural trigger.” Id. at
73.

Later that summer, on July 15, 2013, Ms. Johnson was taken to a pediatric neurologist,
Timothy Lotze, M.D. Ex. 4 at 53-57. Dr. Lotze’s history noted, among other things, that
Petitioner had undergone a muscle biopsy in March that was unremarkable, and that since that
time she had “overall been healthy,” other than some ongoing fatigue along with intermittent
leg pains. Id. at 53. She had (as noted above) received a negative work-up for myasthenia gravis,
and other studies for metabolic myopathy were normal. Her neurological exam was normal, and
Dr. Lotze observed that “I cannot find a neurological condition to explain her complaints of

6
 muscle aches and joint pains.” Id. at 57. He also noted that Mrs. Johnson expressed to him the
opinion that Petitioner’s symptoms were related to the Gardasil vaccine, but did not make any
further comment. Id.

Petitioner returned to Dr. Quarles on August 7, 2013, reporting ear pain, plus ongoing
weakness and leg pain of unknown etiology. Ex. 4 at 50. Mrs. Johnson expressed the concern
that no diagnosis had been made to explain the cause of her daughter’s symptoms, and raised
again “the possibility of association with Gardasil administration,” adding that the Johnsons
claimed familiarity with other young women who had experienced the same purported reaction.
Id. Dr. Quarles found nothing specifically wrong after examination, and proposed that Petitioner
consider seeing a rheumatologist. Id. at 51.

Later that month, on August 21, 2013, Petitioner saw Amber Yates, M.D., a
hematologist, expressing concerns about a low white blood cell count that had been discovered
by a wellness treater she had been seeing.7 Ex. 4 at 46. Dr. Yates also was informed of Mrs.
Johnson’s view that the HPV vaccine was the source of Petitioner’s symptoms, and was told that
“less than two months after [Petitioner] received it she began to have joint pain,” plus ptosis six
weeks later (although as the record indicates, it did not begin until nearly a year after receipt of
the last HPV dose). A follow-up white blood cell count was normal, and Dr. Yates characterized
any low white blood cell counts Petitioner had experienced as likely the product of her “chronic
medical illness,” although so mild that she was not recommended for additional hematology
follow-up visits. Id. at 48-49.

Ms. Johnson next had a rheumatology consultation with Anna Gironella, M.D., on
October 18, 2013. Ex. 4 at 17. She provided a history of ongoing weakness and associated
symptoms since receiving the third HPV vaccine dose, similar to that given to other treaters in
2013. Id. A physical exam was normal, however, including normal neurologic, muscular, and
respiratory work-ups. As a result, Dr. Gironella assessed the Petitioner as not suffering from any
autoimmune inflammatory condition, whether lupus, dermatomyositis, or a mixed connective

7
See Ex. 4 at 1-11 (testing records from Petitioner’s visits with Dr. Mila McManus at Woodlands Institute for Health
and Wellness). Dr. Lotze also referenced treatments Petitioner received from a similar institution (perhaps the same
one, although incomplete records of these particular treatments were filed), where Petitioner was to undergo
“detoxification” as well as receive screening for “heavy metals.” Ex. 4 at 53.

7
 tissue disease. Id. at 40.

POTS Diagnosis and Tilt Table Test

Even after this case’s filing in 2014, Petitioner and her family continued to seek an
explanation for her symptoms. To that end, they consulted by telephone with Dr. Svetlana
Blitshteyn, a neurologist with a demonstrated expertise in autonomic dysfunction such as
POTS.8 The Johnsons first spoke to Dr. Blitshteyn on July 29, 2015, providing her a history
consistent with what they had given to other providers (and emphasizing their view that
Petitioner’s shortness of breath and weakness began a few weeks after receipt of the third HPV
vaccine dose). Ex. 15 at 1. After reviewing the records provided to her, Dr. Blitshteyn proposed
POTS or some other autonomic disorder as a potential diagnosis, and that it was at least
temporally associated with the relevant HPV vaccine dose. Id. at 2. She proposed, however, a
tilt table test (in which a patient lies flat on a table, which is elevated to measure the tested
individual’s change in blood pressure) to confirm the diagnosis.9 Id. A little more than a month
later, the Johnsons spoke with Dr. Blitshteyn a second time. See Record, dated September 2,
2015 (filed as Ex. 15 at 4-6). The contents of Dr. Blitshteyn’s write-up and evaluation were
largely the same as the July record, and again noted that a tilt table test could confirm a POTS
diagnosis. Id.

Thereafter, and while this case was pending, I proposed that Petitioner obtain a tilt table
test, assuring her that because such a test would be useful in resolving her claim, its cost could
be reimbursed as part of an attorney’s fees award in this matter. See Order, dated August 9, 2016
(ECF No. 47). Petitioner did so on September 16, 2016, at Children’s Memorial Hospital in
Houston, Texas, obtaining a result that the doctor performing the test deemed evidence of “mild

8
Dr. Blitshteyn has previously submitted expert reports and testified in multiple Vaccine Program cases where
petitioners allege a vaccine-induced POTS injury or an HPV vaccine-induced injury. See, e.g., Rivera v. Sec’y of
Health & Human Servs., No. 15-487V, 2017 WL 2460690 (Fed. Cl. Spec. Mstr. Apr. 20, 2017); Martin v. Sec’y of
Health & Human Servs., No. 14-325V, 2016 WL 4437961 (Fed. Cl. Spec. Mstr. July 25, 2016); Turkupolis v. Sec’y
of Health & Human Servs., No. 10-351V, 2014 WL 2872215 (Fed. Cl. Spec. Mstr. May 30, 2014).
9
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 Mar. 6, 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.

8
 to moderate autonomic dysfunction.” See Ex. 19 (filed as ECF No. 52-1). Petitioner did not,
however, obtain any supplemental reports or treater views interpreting the results, from Dr.
Blitshteyn or anyone else. See Status Report, dated October 21, 2016 (ECF No. 53).

II. Witness Testimony

A. Kailey Johnson

Petitioner was the first fact witness to testify in this action. See Tr. at 182-94. She began
by discussing her childhood leading up to vaccination, describing her early years as “pretty
normal.” Id. at 183. She participated in a number of athletic activities, including softball and
basketball. Id. at 183-84. Apart from a cold (or something similar), Ms. Johnson stated that she did
not have any medical problems prior to receiving the third HPV vaccine dose in February 2011.
Id. at 184.

Ms. Johnson denied having any immediate adverse reaction to the HPV vaccine (including
lightheadedness or fainting), although she recalled that the actual administration of the vaccine
was painful. Tr. at 184-85. Thereafter, however, she began to notice adverse symptoms (including
joint and leg pain, and concerns relating to “falling behind in [sports] workouts”) between April
and May 2011. Id. at 185. Such concerns were not present when she saw Dr. Gilbert in March of
that same year to treat a cold. Id. She started to notice her symptoms more in April 2011, when she
participated in a tornado relief effort in Tuscaloosa, Alabama. Id. at 186-87. At that time, she
remembered being generally tired, and having to “sit down a lot” during the entire trip. Id. She
contemporaneously informed her mother about the symptoms she was experiencing. Id. at 187.

Ms. Johnson testified that such symptoms continued through the 2011 summer and into the
new school year. Tr. at 187. She continued to struggle with keeping up in basketball practice due
to the fatigue she felt on exertion, and eventually quit the team. Id. Her course of symptoms
worsened around the time of her family’s move to Texas in 2012. Id. at 188-89. She now began
experiencing problems concentrating in school, and started to miss classes. Id. at 190. She would
constantly feel “really tired” and need extra sleep to regain her energy. Id.

Ms. Johnson also recalled the day she presented for the tilt table test in September 2016.
At this time, she felt normal during the test, apart from some occasional tightening in her chest.

9
Tr. at 191. However, later in her testimony, she stated that she did feel lightheaded or “a little
spotty” during the testing, but noted she did not complain because she felt this way generally when
she stood up during her everyday activities. Id. at 192. Following the tilt table test and a change to
her medication, she began to feel much better, and with that her feelings of faintness after standing
subsided. Id. at 192-93.

B. Charmaine Johnson

Petitioner’s mother, Mrs. Charmaine Johnson, testified about her daughter’s health history
and symptomology course following her receipt of the third HPV vaccine. See Tr. at 146-82. Mrs.
Johnson described her daughter as a happy, healthy, “easy to raise child,” who was a good student
with many sports and extracurricular activities. Id. at 147. She accompanied Petitioner to the
appointment where she received her third round of the HPV vaccine, and observed no immediate,
adverse reaction to it. Id. at 148. She did not display any symptoms relevant to the claim herein at
the March 2011 doctor’s visit, such as shortness of breath. Id. at 149. However, by April 2011 -
two months following her third HPV vaccine – Petitioner began complaining of joint and leg pain,
as well as difficulty taking deep breaths. Id. at 149, 151. Mrs. Johnson characterized this time as
when Petitioner first experienced the symptoms relevant to her alleged vaccine injury. Id. at 181.

Mrs. Johnson observed Petitioner’s symptoms become more severe in May 2011. Tr. at
152. During this time, Ms. Johnson described Petitioner as feverish and “much sicker, in bed, [and]
not able to go to school.” Id. Petitioner was diagnosed with bronchitis, and Mrs. Johnson recalled
that her daughter had trouble breathing during the visit and appeared “full in her chest.” Id. at 154.
Although the medical record from the May 19th appointment states that symptoms had started two
days prior, Mrs. Johnson interpreted the doctor’s note to mean actually that the symptoms had
become progressively worse over the previous two-day period – not that they began two days
before. Id. at 152-53. Mrs. Johnson next recalled taking Petitioner back to the doctor on June 11,
2011. Id. at 154-55. Petitioner was still experiencing adverse symptoms (including droopiness,
lethargy, and fatigue). Id. at 155. She disputed the accuracy of medical records characterizing these
symptoms as mild, maintaining instead that they were far more severe, although they were
progressing in only a gradual manner. Id. at 156, 160-61.

By the time school started in August, Petitioner’s complaints concerning shortness of

10
breath had worsened, and she became unable to participate in school sports due to leg pain and
respiratory problems. Tr. at 157, 161. In Mrs. Johnson’s view, her symptoms were now progressive
in character (and she disputed other record assertions about symptoms beginning only a few days
prior, such as stated in the record from Petitioner’s September 2011 doctor’s visit). Id. at 159-60.
By 2012, Petitioner’s increasingly worse symptoms (in particular, headaches) resulted in her
hospitalization in order to rule out myasthenia gravis – and even if that diagnosis was then
discounted, Mrs. Johnson found it frustrating that treaters could not figure out what was wrong
with Petitioner. Id. at 162-63.

Over the next three years, Mrs. Johnson testified, the Johnson family obtained a variety of
potential explanations for Petitioner’s symptoms (including asthma, pneumonia, bronchitis, brain
tumor, brain aneurysm, and myasthenia gravis). Tr. at 168. Eventually, Petitioner’s weakness,
“brain fog,” and sleepiness were severe enough to limit her ability to attend high school due to
absences. Id. at 169-70. Her symptoms did, however, seem to “level[] off” for the remainder of
2014-2015. Id. at 170.

Mrs. Johnson also provided some details about Petitioner’s consultation with Dr.
Blitshteyn and her proposed POTS diagnosis. Tr. at 171-72. Dr. Blitshteyn also recommended that
Ms. Johnson request that Kailey be prescribed certain medication, including Amitriptyline and
Florinef.10 Id.at 172. And Mrs. Johnson testified that she attended the tilt table test for her daughter
in September 2016. Id. at 174. At this time, Petitioner expressed few physical complaints during
the procedure, apart from experiencing a “little chest pain” – something that Mrs. Johnson said
surprised the testing physician, who observed a large heart rate increase of 40 beats per minute. Id.
at 176. Since Petitioner was prescribed Florinef, she has experienced some improvement in how
she feels. Id. at 177.

C. Brady Johnson

Mr. Brady Johnson, Petitioner’s father, also testified at hearing. His testimony largely
mirrored that of her mother’s statements, and included an overall view of his daughter’s health
course following her vaccination. See Tr. at 194-201. According to Mr. Johnson, the Petitioner

10
According to Dr. Blitshteyn’s notes, she prescribed Amitriptyline for “headache prevention and widespread body
pain,” and Florinef for “volume expansion.” Ex. 15 (ECF No. 34-1) at 5.

11
was an active child who participated in a number of activities, including basketball, and was very
successful overall. Id. at 195-96. Mr. Johnson first began to notice a change in Petitioner’s health
when she was in the sixth grade, specifically during basketball tryouts in fall 2011, when she
started to feel short of breath and display lethargy when exerting herself physically. Id. at 196-97.
Although Mrs. Johnson attended the majority of Petitioner’s doctor’s appointments, he was aware
of the nature of her symptoms, and was frustrated they could not be explained. Id. at 198-99. He
did, however, notice improvement after her POTS diagnosis and change in medication. Id. at 199-
200.
III. Expert Testimony

A. Dr. Yehuda Shoenfeld

Dr. Shoenfeld filed three expert reports in this case and testified at hearing. See Expert
Report, dated September 6, 2015, filed as Ex. 49 (ECF No. 84-16) (“Shoenfeld First Rep.”); Expert
Report, dated March 31, 2016, filed as Ex. 44 (ECF No. 84-11) (“Shoenfeld Second Rep.”)11;
Expert Report, dated August 30, 2017, filed as Ex. 34 (ECF No. 84-1) (“Shoenfeld Third Rep.”);
Tr. at 5-138. He provided the opinion that Ms. Johnson suffered from POTS as a result of receiving
the third HPV vaccine. Id. at 8, 11.

Dr. Shoenfeld, an internist and clinical immunologist, identifies himself as heading the
Center for Autoimmune Diseases, which he founded at the Sheba Medical Center in Israel.
Shoenfeld First Rep. at 1; Tr. at 7. He also holds the Laura Schwarz-Kipp Chair for Research of
Autoimmune Diseases at Tel Aviv University. Shoenfeld First Rep. at 1. His experience focuses
on autoimmune and rheumatic diseases, and he has published many peer-reviewed papers in
journals and books on these topics. Id. He is on the editorial board of 32 journals in the field of
autoimmunity, and regularly partakes in speaking engagements at conferences centered on
autoimmune issues. Id. However, Dr. Shoenfeld lacks specialized expertise in POTS or POTS-

11
Earlier in the case, much of Dr. Shoenfeld’s theory relied heavily on the concept that an aluminum-derived adjuvant
contained in the vaccine was a mechanism for the autoimmune process that he proposed was the cause of Ms.
Johnson’s POTS. However, in the course of the matter’s adjudication, I pointed out to the Petitioner that this theory
(referred to as “autoimmune syndrome induced by adjuvants,” or “ASIA”) had been rejected several times in the
Program in other cases as scientifically unreliable, and I was not disposed to accepting it myself. See Order, dated
January 8, 2016 (ECF No. 40). Petitioner thereafter opted to pursue her claim without relying on ASIA as an
explanatory mechanism, and Dr. Shoenfeld at hearing avoided embracing it (at least openly). See Tr. at 57-58, 77-78.

12
related diseases (or pediatric diseases), is not himself a pediatrician, and has no identified history
of treating or diagnosing pediatric patients with any such illnesses. Id. at 105.

Dr. Shoenfeld described POTS as an “inadequate reaction to the change of position” -- for
example, going from a lying down position to standing. Tr. at 91. POTS is properly classified as a
“dysfunction of the autonomic system,” which can result from dysregulation of the blood vessels
responsible for adjusting the heart rate when the body changes position. Id. at 24. According to
Dr. Shoenfeld, patients suffering from POTS typically experience an increased heart rate,
accompanied by a drop in blood pressure, due to the heart’s attempt to compensate for lack of
blood supply to the brain. Id. Symptoms can include lightheadedness, dizziness, syncope, and
severe fatigue. Id. at 11, 92. He was somewhat vague, however, in explaining whether POTS is a
condition distinct from orthostatic intolerance, or merely a kind of orthostatic intolerance. Id. at
93.

Dr. Shoenfeld asserted that POTS is a progressive, slowly-developing condition. Tr. at 95;
see also K. Ozawa, et al., Suspected Adverse Effects After Human Papillomavirus Vaccination: a
Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in
Japan, 40 Drug Saf. 1219, 1-11 (https://doi.org/10.1007/s40264-017-0574-6) (2017), filed as Ex.
91 (ECF No. 89-1) (“Ozawa”). He also proposed that it is autoimmune in nature. In so testifying,
Dr. Shoenfeld explained that autoimmune diseases generally manifest as a result of both genetic
and environmental factors, and typically occur in young women. Tr. at 14-15. An autoimmune
disease or disorder is in essence an instance in which an individual’s immune system reacts
hyperactively, attacking self along with foreign infectious agents. Id. at 15-16. With respect to
POTS specifically, Dr. Shoenfeld relied on the presence of certain autoantibodies in patients
diagnosed with POTS as evidence of its autoimmune nature. Id. at 23. He also offered some
literature that he said established this – in particular, a Mayo Clinic article prepared by eminent
members of Mayo’s Autonomic Disorders Center. Id.; M. Thieben, et al., Postural Orthostatic
Tachycardia Syndrome: the Mayo Clinic Experience, 82 Mayo Clin. Proc. 308, 308-13 (2007),
filed as Ex. 20 (ECF No. 54-1) (“Thieben”) (finding approximately 14 percent of tested POTS

13
patients had low positive values for ganglionic12 AChR antibody13). And he noted as well other
research involving lupus (known to be an autoimmune condition) that had observed that a large
percentage of lupus patients also experienced orthostatism, thereby allowing the inference that
orthostatic disorders could themselves also be autoimmune in nature. Tr. at 24.

To connect the HPV vaccine specifically to POTS, Dr. Shoenfeld cited several items of
literature discussing case reports that he maintained support such a link. Tr. at 25. For example, a
Japanese study recorded four instances of POTS in a group of 40 teenage girls who had recently
received the HPV vaccine, plus eight more who displayed signs of orthostatic hypotension. T.
Kinoshita, et al., Peripheral Sympathetic Nerve Dysfunction in Adolescent Japanese Girls
Following Immunization with the Human Papillomavirus Vaccine, 53 Intern. Med. 2185, 2185-
2200 (2014), filed as Ex. 89 (ECF No. 85-24) (“Kinoshita”). Kinoshita, however (as later pointed
out by Respondent’s expert), was somewhat marred by self-selection,14 since the studied
individuals all voluntarily reported to a Japanese syncope clinic (and therefore the study lacked
any control group), and it did not involve any specific investigation into the actual causal role of
the vaccine. A similarly-structured study in Denmark (focusing on young women who had recently
received the HPV vaccine and were then referred to a syncope treatment unit due to reported
orthostatic intolerance symptoms) observed 21 cases of POTS out of 35 studied individuals. L.
Brinth, et al., Orthostatic Intolerance and Postural Tachycardia Syndrome as Suspected Adverse
Effects of Vaccination Against Human Papillomavirus, 33 Vaccine 2602, 2602-05 (2015), filed as
Ex. 24 (ECF No.54-4) (“Brinth”). He also attempted to relate POTS to the HPV vaccine by noting
that POTS patients frequently experience small fiber neuropathy – a condition that has been
vaccine-associated (although not connected to the HPV vaccine specifically). Tr. at 29-30.15

12
Ganglionic is defined as “pertaining to a ganglion.” Dorland’s at 760. A ganglion is an anatomical term for a “group
of nerve cell bodies located outside the central nervous system.” Id. at 757. The term can also be applied to a group
of nuclear cell groups within the brain. Id.
13
A ganglionic AchR antibody is the most commonly detected marker for autoimmune dysautonomia. See Testing for
Autoimmune Disorders, Mayo Clinic, https://www mayomedicallaboratories.com/articles/features/autoimue/index.
html (last accessed on Mar. 6, 2018).

14
Self-selection or self-reporting can be a form of selection bias. Selection bias is defined as “systematic error due to
[a] nonrandom selection of subjects for study.” Reference Manual on Scientific Evidence 296 (3rd ed. 2011).

15
Petitioner also offered an article written by the primary treater who diagnosed her POTS, Dr. Blitshteyn. See S.
Blitshteyn, Postural Tachycardia Syndrome Following Human Papillomavirus Vaccination, 21 Eur. J. Neurol. 134-

14
 Based on such literature and studies, Dr. Shoenfeld maintained that there was a plausible
biologic mechanism by which the HPV vaccine could cause POTS: molecular mimicry. Shoenfeld
First Rep. at 19-20. Dr. Shoenfeld described molecular mimicry as occurring when the body is
exposed to an environmental factor (such as a vaccine or infection), which results in a cross-
reaction between autoantibodies (produced by the body) and a self structure that the foreign antigen
has mimicked. See N. Agmon-Levin, et al., Vaccines and Autoimmunity, 5 Nat. Rev. Rheumatol.
648, 650 (2009), filed as Ex. 81 (ECF No. 85-16) (“Agmon-Levin”); Tr. at 38; Shoenfeld First
Rep. at 18-20. In so proposing, Dr. Shoenfeld relied almost exclusively on a single scientific article
to establish homology between protein components of the HPV vaccine and human protein
structures. Tr. at 22; D. Kanduc, et al., Quantifying the Possible Cross-Reactivity Risk of an HPV16
Vaccine, 8 J. Experimental Therapeutics & Oncology 65, 65-76 (2009), filed as Ex. 84 (ECF No.
85-19) (“Kanduc”); Shoenfeld First Rep. at 20. Kanduc examined the HPV16 polyprotein and
recorded amino acid sequence similarities to the human proteome at the heptamer level,
concluding that the proteome contains eighty-two heptapeptides and two octapeptides also found
in the HPV16 vaccine. Kanduc at 65. There was thus, in Dr. Shoenfeld’s view, sufficient identity
between a vaccine component and “our body constituents” for a cross-reaction to theoretically
occur. Tr. at 22. He admitted that most homology between a foreign antigen and self protein
structure is not meaningful in a pathogenic sense, but nevertheless maintained that “it’s [a]
completely different story” when vaccine is involved, given a vaccine’s capacity to stimulate the
immune system (due largely to the adjuvants contained therein). Id. at 100-02.

Dr. Shoenfeld was somewhat less certain as to where in the body this cross-reaction was
purportedly occurring. At best, he proposed that the target antigen for the reaction involved in his
theory is the channel receptor (potassium or calcium). Tr. at 136. More specifically, he categorized
the location as a nerve ending receptor, “maybe in the heart, or where the autonomic nervous
system resides.” Id. at 137. Dr. Shoenfeld did not submit literature to support his target antigen
opinion, however, but relied on literature supporting a broad application of his theory, suggesting

39 (2014), filed as Ex. 21 (ECF No. 54-2) (“Blitshteyn”). In it, Dr. Blitshteyn reviews six case studies of post-
HPVvaccine POTS, three of whom had also been diagnosed with small fiber neuropathy. Blitshteyn at 136,Table 1.
Although the article does favor classification of POTS as autoimmune, it does not state that small fiber neuropathy is
linked to POTS. Blitshteyn at 138. In addition, Blitshteyn’s case studies all involved symptoms onset occurring no
later than two months post-vaccination (see Table 1), and Dr. Blitshteyn hedged in suggesting the reliability of the
conclusion that the HPV vaccine was causal. Id. (temporal association between HPV vaccine and POTS “deserves
further investigation for assessment of a possible causal relationship” (emphasis added)).

15
that the cross-reaction occurs between the vaccine component and self antigens generally or host
tissue expressing antigens. See Agmon-Levin at 3; Kanduc at 1. Even so, this aspect of his theory
otherwise reflected a topic outside of his immediate research expertise or practical experience, and
he cited no literature directly addressing the autoimmune nature of POTS. Indeed – he largely
admitted that, other than evidence of homology between the HPV vaccine and certain self proteins,
and some speculation as to the target for the autoimmune attack, he could offer little in the way of
evidence suggesting that the HPV vaccine had ever been shown from a reliable experiment or
study to be pathogenic in the way argued herein. Id. at 138.

Dr. Shoenfeld also proposed a possible inciting factor in the theorized autoimmune cross-
reaction: alum, an adjuvant included in the HPV vaccine due to its ability to elicit a more vigorous
immune response. Tr. at 16, 28, 38; Shoenfeld First Rep. at 18. In support, he referenced several
pieces of literature exploring the precise means by which alum accomplishes its immune system-
stimulating function, resulting in an increase in autoimmune manifestations in humans. See, e.g.,
Agmon-Levin; N. Agmon-Levin, et al., Chronic Fatigue Syndrome with Autoantibodies – The
Result of an Augmented Adjuvant Effect of Hepatitis-B Vaccine and Silicone Implant, 8
Autoimmun. Rev. 52, 52-55 (2008), filed as Ex. 63 (ECF No. 84-30). Dr. Shoenfeld opined that if
the HPV vaccine had not contained the alum adjuvant, Ms. Johnson would not have experienced
any autoimmune reaction resulting in POTS. Tr. at 38.16

After outlining his theory, Dr. Shoenfeld attempted to apply it to Ms. Johnson’s medical
history. First, he maintained that Ms. Johnson’s medical record established the accuracy of her
POTS diagnosis. He documented POTS symptoms that he maintained the medical record
established: lightheadedness, dizziness, syncope, palpitations, exacerbation by exercise, weakness,
dyspnea, shortness of breath, cold extremities, visual disturbances, nausea, and trouble sleeping.
Tr. at 11, 30-31. He also noted that she had a somewhat low white blood cell count, which can
evidence a lack of blood supply to the periphery. Id. at 12. Dr. Shoenfeld acknowledged, however,
that Ms. Johnson had displayed a low white blood cell count prior to vaccination. Id. at 47-48.

16
In making this argument, Dr. Shoenfeld was careful to add that he was not invoking ASIA theory (see, e.g., Tr. at
57-58) – although such protestations were undermined by the very fact that he could not help but stress the role of the
vaccine’s adjuvant in causing the alleged autoimmune reaction, even if he did not refer to this with the ASIA acronym.

16
 Additional evidence of the autoimmune character of Petitioner’s POTS was the fact that
Ms. Johnson tested positive for a high (or, more accurately, a “weak elevated”) antinuclear
antibody (“ANA”) level during a visit to a rheumatologist in October 2013. Tr. at 12-13, 45, 133.
Dr. Shoenfeld stressed that even a slightly positive ANA could support the existence of an
autoimmune disease. Id. at 41. He later, however, acknowledged that ANAs are not associated
directly with POTS, and that positive ANA levels were otherwise not primary evidence of the
existence of an autoimmune disease.17 Id. at 46. He also stressed the importance of family history
suggesting a common susceptibility to autoimmune diseases, noting that Petitioner’s family had
reported several autoimmune conditions. Id. at 17-19, 178-79 (Mrs. Johnson testifying about
family disease history such as hypothyroidism).18 Dr. Shoenfeld noted that there are genetic
markers correlated with a tendency to develop autoimmune diseases, although he acknowledged
that he was not aware of one specifically associated with POTS. Id. at 135.

However, Dr. Shoenfeld admitted that even circumstantial proof corroborating the
autoimmune character of Ms. Johnson’s symptoms was limited. For example, treaters never tested
Ms. Johnson for any of the autoantibodies that arguably might be related to POTS or other
dysautonomic disorders or diseases. Tr. at 24. But he opined generally that autoimmune diseases
generate “plenty” of autoantibodies, and the lack of specific evidence that an individual possesses
a particular one does not diminish the conclusion herein that Ms. Johnson experienced autoimmune
POTS due to the third dose of the HPV vaccine. Id. Overall, Dr. Shoenfeld opined that the main
factors evidencing an immune reaction in the Petitioner included her course of symptoms, the
presence of the elevated ANA levels, and the fact of the POTS diagnosis itself (which he insisted
is known to be an autoimmune condition). Id. at 134 (“we don’t need more than the disease is of
an autoimmune nature”). Id.

As to onset, Dr. Shoenfeld opined that Ms. Johnson initially developed POTS symptoms

17
In his expert report, Dr. Shoenfeld also stated that Ms. Johnson’s test results indicated the presence of
antiphospholipid antibodies and lupus anticoagulant, which he relied upon in opining as to the underlying autoimmune
nature of Ms. Johnson’s condition. Tr. at 48. However, he later corrected that statement, confirming that her results
did not indicate the presence of either. Id.; see also Id. at 49-50. In so doing, he admitted that part of his original report
had been mistakenly copied from a report submitted on behalf of a different Vaccine Program petitioner. Id. at 53-55.
18
Respondent’s expert, Dr. Kenneth Mack, agreed that individuals genetically predisposed to autoimmunity would
more likely have an abnormal response to vaccination (although, as discussed below, he largely disputed the
contention that POTS is broadly an autoimmune condition. Tr. at 274.

17
five weeks post-vaccination, or by March 29, 2011, becoming progressively worse over the next
year or more. Tr. at 32-33, 61, 65, 70. In so arguing, Dr. Shoenfeld forcefully maintained that even
though the records from the March 29th visit do not mention symptoms that could be deemed
evidence of POTS, such as shortness of breath, they were incorrect, reflecting a misdiagnosis or a
treater’s view that her shortness of breath was not severe enough to constitute “true” dyspnea. Id.
at 69, 102, 104.19 Thus, Dr. Shoenfeld proposed that where a record stated that treaters observed a
cough, or that Petitioner had informed them she was coughing, the record was in error. Id. at 32,
64. He relied in part on Mrs. Johnson’s testimony for this interpretation of the record, suggesting
that she more reliably recalled her daughter’s symptoms than contemporaneous treaters. Id. at 71.20
He also proposed that, because Petitioner was an early adolescent, she had likely confused her own
shortness of breath for a cough, and thus misinformed her treaters. Id. at 65, 103. And the fact that
Petitioner did not report in March 2011 other POTS symptoms, such as fatigue, was dismissed by
Dr. Shoenfeld as irrelevant, given his view that POTS would invariably progress over time. Id. at
64, 65, 94-95.

Dr. Shoenfeld similarly attempted to rebut other contemporaneous medical records that
were inconsistent with his theory. When asked about Petitioner’s May 2011 records (when she was
diagnosed with bronchitis, and an x-ray revealed lung congestion suggestive of pneumonia), Dr.
Shoenfeld maintained that the fact that she did not report a fever at the time was “unusual,” since
he would associate any such inflammatory condition with fever – and therefore her treaters again
likely misdiagnosed her. Tr. at 68-69. He also pointed to the absence of complaints of dyspnea at
this time (a significant clinical factor, under his theory, evidencing POTS) as undermining the
suggestion she had pneumonia, since in his view “there is no pneumonia . . . without shortness of

19
Dr. Shoenfeld went quite far in his attempt to dispute the accuracy of Ms. Johnson’s diagnosis at this time (and in
doing so made some assertions that were highly unpersuasive, if not confusing). For example, he challenged the
accuracy of the URI diagnosis by arguing that her treaters never identified the exact viral infection at issue via testing,
and therefore their diagnosis lacked foundation. Tr. at 65-66. He also seemed to suggest that whether Ms. Johnson’s
infection was bacterial or viral was significant to her diagnosis, although he did not articulate in a clear fashion why
this was so. Id. at 67-68.

20
Dr. Shoenfeld’s trust in the accuracy of Mrs. Johnson’s testimony and recollection about the nature of Petitioner’s
symptoms, in contrast to what the record sets forth, was inconsistent. Thus, although the May 2011 records seem to
indicate that Petitioner was diagnosed with pneumonia and/or bronchitis – something Mrs. Johnson’s witness
statement admits (Tr. at 154) – Dr. Shoenfeld maintained that this diagnosis was also incorrect, and that all Mrs.
Johnson was doing was repeating what she was told. Tr. at 73-75.

18
breath.” Id. at 70. By June 2011, when Petitioner did report shortness of breath but her treaters
characterized that as reflecting her recovery from bronchitis, Dr. Shoenfeld proposed instead
(along with his consistent contention that these treaters erred) that Petitioner’s 2015 diagnosis of
POTS revealed, in hindsight, the error of this interpretation of her symptoms. Id. at 87. Dr.
Shoenfeld offered comparable critiques of Ms. Johnson’s September 2011 doctor’s visit, when she
was diagnosed with strep throat. Id. at 88-90.

By contrast, Dr. Shoenfeld asserted that the records of Ms. Johnson’s 2012 hospitalization,
and suspicion that she was suffering from myasthenia gravis, were wholly consistent with his
theory. Myasthenia gravis is considered an autoimmune disease, with autoantibodies similar to
those thought related to POTS. Tr. at 97-98. Dr. Shoenfeld was, however, compelled to admit that
Petitioner had not tested positive for such autoantibodies. Id. at 98-99.

While diminishing the accuracy of early treater views, Dr. Shoenfeld placed great weight
on Dr. Blitshteyn’s POTS diagnosis, coupled with the 2016 tilt table test, despite the fact that both
were obtained more than five years after Petitioner’s HPV vaccination. Tr. at 59, 94-94, 135. In
his view, the delayed diagnosis was somewhat consistent with the condition itself, stating that “you
cannot actually see the orthostatism” early in POTS, both due to its progressive nature as well as
the fact that individuals suffering from it will take steps to avoid symptoms (for example, by not
standing abruptly). Id. at 97, 123-24. Dr. Shoenfeld argued, however, that Ms. Johnson likely
would have been diagnosed with POTS as early as 2012 had she been properly tested. Id. at 116.

As far as the appropriateness of the timing of Ms. Johnson’s alleged onset, Dr. Shoenfeld
proposed that five weeks was adequate. Indeed – he allowed that an onset of up to seven months,
if not several years, could be medically appropriate, depending on the type of autoantibodies
induced by the vaccine. Tr. at 131-32. For support, Dr. Shoenfeld referenced Ozawa, which found
that the average appearance of symptoms following HPV vaccine was 360 days from vaccination.
Id. at 87; Ozawa at 9. Ozawa itself, however, notes that the average time for onset observed was
“very long in comparison with the adverse effects of conventional vaccinations,” attributing this
in part to the fact that “it is rather difficult to determine the exact time of onset” – not to mention
the study’s other acknowledged limitations (lack of control group, self-selection of studied
subjects, etc.). Ozawa at 9. Dr. Shoenfeld for his part was dismissive of placing any time limit on

19
what would be reasonable for onset of a vaccine-induced injury, arguing that (based on his
expertise in studying autoimmune illnesses) a post-vaccination onset of several weeks was no more
reliable or appropriate than several months. Tr. at 33.

As an overall matter, Dr. Shoenfeld acknowledged that his opinion was based to a large
extent on the discrepancy between Ms. Johnson’s pre-vaccination health record (which revealed
no documented medical problems prior to vaccination) and her subsequent problems, as well as
the fact that her many treaters (before Dr. Blitshteyn) were unable to identify an explanation for
her condition more persuasive than the POTS diagnosis. Tr. at 12, 27.

B. Dr. Kenneth Mack

Dr. Mack served as Respondent’s expert, filing two reports in the case and testifying at
trial. See Report, dated December 7, 2015, filed as Ex. A (ECF No. 39-1) (“First Mack Rep.”);
Report, dated February 10, 2017, filed as Ex. C (ECF No. 59-1) (“Second Mack Rep.”); Tr. at 202-
336.21

As his CV indicates, Dr. Mack is the chair of child and adolescent neurology at the Mayo
Clinic in Rochester, Minnesota. CV, filed as Ex. P (ECF No. 94-1) at 2 (“Mack CV”); Tr. at 203.
Dr. Mack received his undergraduate degree, medical degree, and PhD from the University of
Illinois. Mack CV at 2; Tr. at 204-06. Following medical school, he completed residencies in both
pediatrics and neurology, and a fellowship in child neurology at Washington University. Mack CV
at 1. Currently, he is board certified in neurology with special qualifications in child neurology.
Mack CV at 3. At hearing, Dr. Mack testified that 90 percent of his time is devoted to seeing
patients – mostly children – and his specialty is headaches and associated symptoms, such as
dizziness. Tr. at 206. His opinion in this case was based solely on his own expertise and review of
the Petitioner’s medical records. Id. at 248-49.

Dr. Mack is admittedly not an expert on autonomic issues or POTS, although he does see
hundreds of patients a year who suffer from it or some other form of orthostatic intolerance. Tr. at

21
Respondent also filed (on August 18, 2017) a one-page clarification of Dr. Mack’s second report, in order to correct
a statement therein. His second report had said that he agreed Ms. Johnson had POTS – but he meant to say only that
she had “symptoms of” POTS, without accepting Dr. Blitshteyn’s diagnosis. Ex. N, filed as ECF No. 79-2.

20
206. He also has published a few articles on POTS. Id. at 207. In particular, Dr. Mack co-authored
with some of his Mayo Clinic colleagues a review article on the existing scientific and medical
thinking about POTS, and also more recently co-authored an article specifically exploring whether
there is a reasonable scientific association between the HPV vaccine and POTS. J. Johnson, et al.,
Postural Orthostatic Tachycardia Syndrome: A Clinical Review, 42 Ped. Neurol. 77, 77-85 (2010),
filed as Ex. A, Tab. 7 (ECF No. 46-2) (“Johnson”); B. Butts, et al., Human Papillomavirus Vaccine
and Postural Orthostatic Tachycardia Syndrome: A Review of Current Literature, 20 J. Child
Neurol. 10:1-10 (2017), filed as Ex. O (ECF No. 79-3) (“Butts”).22 Dr. Mack’s writing on these
topics renders him (in his view) “one of the more knowledgeable people in the United States” on
the condition. Tr. at 247. Dr. Mack does not, however, have specific training in immunology. Id.
at 249.

Dr. Mack began with a discussion of POTS. He deemed it a type of orthostatic intolerance,
characterized by dizziness and lightheadedness upon standing, but which can be alleviated by
“recumbency” (sitting or lying down). Tr. at 210-12. It is a common in adolescence, although it
can vary in how it presents and its overall symptoms. Id. at 210. Dr. Mack did not deem it a
progressive condition, noting that some individuals may experience POTS symptoms in a transient
manner, while others will display consistent symptoms over a long period of time, without ever
experiencing an increase in severity. Id. at 335-36. The etiology of POTS is uncertain, although
Dr. Mack did allow that it can develop secondarily to a chronic illness, as a result of
“deconditioning” - where an individual has greatly limited her physical activity, resulting in a
weakening of blood vessels and a corresponding inability to respond to orthostatic changes. Id. at
214, 217-18.

Dr. Mack agreed with Dr. Shoenfeld that it is not easy to diagnose POTS, although he did

22
Dr. Mack admitted under cross-examination that at the time Butts was written, he was consulting with the
Government with respect to Vaccine Program matters, and was also aware that he could be asked to testify on the
issues relating to POTS discussed in Johnson (although he denied that the paper was prepared for that purpose). Tr. at
267-68. Problems can arise when any expert offers his own literature to support an opinion – especially if that literature
has been prepared with some eye toward its use in litigation. However, I do not find in this case that Dr. Mack’s
authorship of this article raises a tenable credibility problem impacting the weight to be afforded his testimony –
especially given his demonstrated expertise with POTS from a clinical perspective. If it did, then I would also have to
consider not only the fact that Dr. Shoenfeld references (by my count) 20 articles he co-authored as supporting his
opinion, but also that he has (in certain cases in which he offered expert opinions) referenced literature directly
addressing the relevant petitioner. 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).

21
propose that the criteria for formal diagnosis in adolescents and children are fairly fixed. Tr. at
264. In particular, he maintained that a POTS diagnosis would need to be supported by a properly-
conducted tilt table test, demonstrating a heart rate increase of 40 beats per minute (“bpm”) for
adolescents and children – more than the 30 bpm necessary to diagnose POTS in an adult. Id. at
211, 293-94, 306, 325-26; see also Butts at 8 (citations omitted). Dr. Mack rejected the concept
that shortness of breath is associated with POTS, although he distinguished it from exercise
intolerance and post-exercise windedness. Tr. at 255-56. Chronic fatigue, on the other hand, can
be a presenting symptom, and individuals diagnosed with chronic fatigue syndrome frequently
have POTS as well. Id. at 261; Johnson at 78. Weight loss often precedes POTS, but POTS does
not lead to it. Id. at 261-62.

Given the nature of Dr. Shoenfeld’s causation theory, Dr. Mack was asked many questions
about his views regarding the purported autoimmune nature of POTS. He acknowledged that
vaccines have been associated with autoimmune diseases, and admitted as well that a particular
ganglionic antibody was at one time considered to have a potential association with certain
instances of POTS (although not all occurrences of POTS could be deemed autoimmune). Tr. at
214-15, 273-74; Johnson at 81; Thieben at 308 (“[o]ur findings suggest . . . a substantial percentage
of [POTS] cases may be autoimmune”), 311 (6 of 42 tested subjects, or 14.3 percent, were positive
for the ganglionic antibody).23 However, he stressed as well that subsequent research and study
had not corroborated a causal relationship with this autoantibody and POTS in any reliable sense.
Tr. at 292. He also emphasized that Petitioner had not been shown to possess this particular
autoantibody. Id. at 298. Dr. Mack otherwise rejected Dr. Shoenfeld’s argument that Ms. Johnson’s
positive ANA was evidence of the autoimmune etiology of her POTS, noting that a significant
number of individuals without an autoimmune illness test positive for heightened ANA titers.24 Id.
at 215, 252-53. Because there was no other record evidence suggesting that Ms. Johnson had ever
experienced any symptoms that might reflect an ongoing autoimmune process, “I struggle to see

23
Dr. Mack also pointed out that Thieben used the term “neuropathic” to describe the kind of cases in which POTS
could be autoimmune (Thieben at 308), but he did not deem that to be coterminous with autoimmunity. Tr. at 291.

24
Dr. Mack made a point of stressing that elevated ANA titers actually raise rheumatologic concerns, since they are
principally associated with known autoimmune rheumatologic diseases like lupus. Tr. at 254. But in Ms. Johnson’s
case, testing evidenced in the medical record (such as C3 or C4 complement levels) never corroborated the presence
of any such diseases, nor did they reveal the presence of ongoing inflammation. Id. at 253.

22
an autoimmune condition here.” Id. at 279, 333-34.25

Dr. Mack directly contested the concept that the HPV vaccine could cause POTS,
frequently referencing studies and literature referenced in Butts (which specifically endeavored to
evaluate the current literature suggesting such a link). See generally Tr. at 236-41 (“there is no
high-quality evidence to show [a] causal relationship”). Butts included evaluation of numerous
items of literature offered in this case by Petitioner, such as Kinoshita and Brinth. Butts at 3-4
(Tables I and II). Butts ultimately concluded, after consideration of each type of scientific evidence
examining the alleged relationship between the HPV vaccine and POTS, that causality could not
be determined even on the basis of the extensive amount of literature examined. Id. at 7-8.

Dr. Mack also pointed out that a number of large-scale cohort epidemiologic studies had
not confirmed any relationship between the vaccine and autoimmune diseases, as well as
conditions involving orthostatic intolerance, such as syncope. Id. at 216-17. In support,
Respondent filed a particular article involving such a large-scale study that often is raised in cases
involving the HPV vaccine, C. Chao, et al., Surveillance of Autoimmune Conditions Following
Routine Use of Quadrivalent Human Papillomavirus Vaccine, 271 J. Intern. Med. 193, 193-203
(2012), filed as Ex. A, Tab 4 (ECF No. 45-4) (“Chao”). Chao (funded but not authored by
Gardasil’s manufacturer, Merck & Co.) was a peer-reviewed observational study analyzing a
database comprised of the medical histories of approximately 189,000 women (members of two
of Kaiser Permanente’s managed care health organizations in the State of California) to determine
whether the studied population had developed a variety of autoimmune conditions after receiving
the Gardasil vaccine. Chao at 194. The researchers compared the results of the studied vaccinated
population with unvaccinated, similarly-situated individuals also enrolled with Kaiser Permanente
in Southern California, in order to compare incidence ratios for the identified autoimmune
conditions. Id. at 194-95. Chao did not observe an increased risk of developing autoimmune

25
Dr. Mack also commented on other aspects of Petitioner’s theory attempting to associate POTS with other conditions
known (or speculated) to be autoimmune. For example, he acknowledged that individuals with small fiber neuropathy
(which is thought to be autoimmune) might also display some autonomic dysfunction, but disagreed that the conditions
are coterminous or closely linked. Tr. at 297-98, 303. And he allowed that, as reflected in Ozawa, the Japanese Health
Ministry had at one point proposed an association between the HPV vaccine and chronic regional pain syndrome
(“CRPS”) - but denied that this association had been reliably demonstrated, disputed that CRPS was associated with
POTS, and also questioned if CRPS could be deemed autoimmune in character. Id. at 305-06.

23
conditions following receipt of the Gardasil vaccine (although Chao did not specifically look for
POTS). Tr. at 238, 281; Chao at 197.26 Other large epidemiologic studies produced similar
outcomes, thereby casting doubt on an association between the HPV vaccine and POTS or some
comparable form of orthostatic intolerance. Tr. at 270-71, 282, 286-88.27 To the extent scientific
or medical articles observed any correlation, they were merely recording a temporal association
attributable simply to the fact that teenage women (the group most likely to experience POTS)
were the primary group receiving the vaccine in the first place. Id. at 277 (“most people who would
develop POTS are at the age where they have been recently exposed to the HPV vaccine”).

Turning to Petitioner’s medical records, Dr. Mack opined that he saw no evidence of any
POTS-associated symptoms any time before her doctor’s visit with Dr. Burris in February 2013.
Tr. at 209, 213. Nothing in Ms. Johnson’s presentation from her March 2011 doctor’s visit was
suggestive of POTS, such as fatigue or dizziness upon standing. Id. at 219-20. Her symptoms
reported in May 2011, such as a productive cough, were (as the contemporaneous treaters
proposed) consistent with pneumonia or bronchitis, but not POTS. Id. at 221, 258. And the
shortness of breath reported after exercise, as reflected in Ms. Johnson’s June 2011 records, was
not significant diagnostically without complaints of light-headedness, which she denied. Id. at 222.

Dr. Mack also commented on aspects of the record discussing instances in which Petitioner
complained of headache – more often in her records beginning in 2012, around the time myasthenia
gravis was suspected. He allowed that headache is a comorbid condition with POTS, but explained
that in his experience, the kind of headache would be different from what Petitioner reported. Tr.
at 226-27, 259. POTS patients most frequently report what Dr. Mack called a “coat hanger”
headache, emanating bilaterally from the neck and shoulders. Id. at 226. The medical record for

26
When cross examined, Dr. Mack admitted that Chao did seem to find an association with Hashimoto’s disease,
which is known to be autoimmune. Tr. at 277-78. However, Dr. Mack noted that Chao stated that “further investigation
of the temporal relationship and biological plausibility revealed no consistent evidence for a safety signal for
autoimmune thyroid conditions.” Id. at 278, quoting Chao at 193.
27
One study referenced by Dr. Mack involved the review of over 600,000 instances of HPV vaccinations given to
females between the ages of nine and twenty-six over a three-year period, and found no statistically-significant
increased risk for a number of adverse events, including syncope. J. Gee, et al., Monitoring the Safety of Quadrivalent
Human Papillomavirus Vaccine: Findings from the Vaccine Safety Datalink, 29 Vaccine 8279, 8279-94 (2011)
(“Gee”). Petitioner attempted to point out language in Gee suggesting its authors’ acknowledgment that it was not
sufficiently powered to detect “rare” occurrences. Tr. at 286. In response, Dr. Mack proposed the view that POTS was
not particularly rare. Id.

24
Ms. Johnson from this time, however, suggested a unilateral headache involving her right eye, and
Dr. Mack could not on the basis of the records available conclude that the headaches she was
experiencing were evidence of POTS. Id. at 227-28, 259-60. He also noted that Petitioner’s ptosis
was not a symptom clinically associated with POTS. Id. at 229.

By the time of Petitioner’s February 2013 visit with Dr. Burris, however, Dr. Mack allowed
that Petitioner was unquestionably experiencing symptoms that made a POTS diagnosis more
credible (even though he did not accept that diagnosis ultimately in this case). Tr. at 229, 249-50,
296. In particular, the record revealed evidence of weakness, recent rapid weight loss, and (most
notably) dizziness when standing up – a strongly-associated presenting symptom of POTS. Id. at
230-33. Because this record noted that Ms. Johnson had been experiencing this set of symptoms
for about three months (Ex. 4 at 70), it was reasonable to conclude their onset had manifested in
November 2012. Id. at 330-31. He affirmatively stated that had he been presented by such a fact
pattern at this time, he would have then ordered a tilt table test to obtain the data needed for a
formal POTS diagnosis. Id. at 335.

With respect to onset, Dr. Mack acknowledged that POTS (if autoimmune in character)
could develop after some kind of trigger within “days to weeks,” although he disputed the
possibility of it developing several months later – let alone almost two years. Tr. at 242, 250. In
his own experience with known autoimmune neurologic illnesses (citing Sydenham’s chorea 28 in
particular), Dr. Mack had never observed an autoimmune pathologic process take more than six
months to occur, and he deemed that timeframe an “outer limit.” Id. at 250-51. He did not accept
the reliability of certain literature cited by Petitioner in support for a longer onset, such as Ozawa,
noting that the case report nature of the study, coupled with the fact that its subjects were self-
selected, greatly diminished its trustworthiness as persuasive scientific evidence – not to mention
the fact that he simply deemed a lengthy onset timeframe to be inherently unreliable. Id. at 318
(“something that had happened [a year] ago does not have a bearing on your current symptoms”),
322-24.

28
Sydenham’s chorea is an acute neurological disorder usually occurring in children between the ages of five and
fifteen. Dorland’s at 354. It is closely linked with rheumatic fever. Id. Symptoms can include involuntary movements
that gradually become more severe (hindering gait, arm movements, and speech). Id. Symptoms can be localized,
affecting only a small portion of the body, or may take the form of muscular rigidity (paralytic chorea). Id.

25
 Dr. Mack was asked on cross examination questions about some of the literature Petitioner
cited in support of her contention that the HPV vaccine is associated with POTS (much of which
he was already familiar with due to his co-authorship of Butts). See, e.g., Tr. at 319-20. As a
general matter, Dr. Mack expressed the view that Petitioner’s literature consistently relied on
passive surveillance reporting or case studies which lacked controls, and therefore merely reported
a correlation that was more likely attributable to the overlap between the age group of POTS
patients and the age of HPV vaccine recipients. Id. at 276, 308. He deemed case reports inherently
less trustworthy than cohort studies, which attempt to compare only like individuals and employ
proper scientific methodologies. Id. at 309-10. As a result, he greatly discounted the value of
literature like Kinoshita or Brinth, both of which involved self-selection by the studied subjects
(since only those who chose to seek treatment for syncope were included as subjects) and otherwise
lacked the scientific reliability of large-scale cohort study. Id. at 307, 314, 316.

Dr. Mack ultimately did not accept the POTS diagnosis made by Dr. Blitshteyn, noting that
no other treaters in Ms. Johnson’s medical history supported it. Tr. at 236, 247-48. He also disputed
the accuracy of the 2016 tilt table test, maintaining that medication the Petitioner was taking at the
time might have skewed the results, and also questioning whether the test in fact was conducted
appropriately or measured the 40 bpm increase necessary to make the diagnosis for an adolescent.
Id. at 233-36, 262, 327, 329. At best, he allowed for the fact that Petitioner had some symptoms
that could be deemed associated with POTS. Id. at 244. He also acknowledged that the complexity
of her overall presentation made an overarching diagnosis difficult. Id. at 213, 244.

IV. Procedural History

As stated above, this case was initiated in March 2014. After nearly a year of medical
records gathering and filing, Respondent filed her Rule 4(c) Report in March 2015 (ECF No. 23),
recommending against an entitlement award.

In September 2015 (after three requests for an extension), Ms. Johnson filed Dr.
Shoenfeld’s first expert report and numerous items of medical literature in support. In response,
Dr. Mack’s expert report was filed by Respondent in December of that same year. Petitioner
responded by filing two additional expert reports from Dr. Shoenfeld, one in March 2016 (ECF
No. 84-11), and a second in August 2017 (ECF No. 84-1). Petitioner submitted one supplemental

26
report from Dr. Mack in February 2017 (ECF No. 59-1).

After the filing of expert reports, a hearing was set in this matter for October 12, 2017 (ECF
No. 69). 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.

V. 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).29
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.

29
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).

27
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
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

28
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).30
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).
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 Health & Human
Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for

30
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).

29
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
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

30
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
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

31
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).

32
 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
& 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”).

33
 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 article 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”).

ANALYSIS

I. POTS and Orthostatic Intolerance

Although I have discussed above each expert’s views on POTS and its nature and etiology,
a few additional observations relevant to my disposition of this case are in order. First, POTS is
unquestionably a subset of orthostatic intolerance – not something apart from it. See R. Freeman,
et al., Consensus Statement on the Definition of Orthostatic Hypotension, Neurally Mediated
Syncope and the Postural Tachycardia Syndrome, 21 Clin. Auton. Res. 69, 69-72 (2011), filed as
Ex. L (ECF No. 78-9) (“Freeman”); B. Grubb, et al., The Post Tachycardia Syndrome: A Concise
Guide to Diagnosis and Management, 17 J. Cardiovasc. Electrophysiol. 1, 1-5 (2006), filed as Ex.
50 (ECF No. 84-17) (“Grubb”). As a result, evidence relating to orthostatic intolerance conditions
generally, as well as what can cause it, has relevance herein even if POTS is not directly implicated
in that evidence.

Second, POTS is reflective of some kind of dysfunction in the autonomic nervous system
(the passive arm of the overall nervous system), which literature filed in this case explains as an
increase in heart rate caused by a change in body position from the supine position to the upright
position. See Grubb at 1; Freeman at 4. In POTS, the “body’s ability to recover from the initial

34
hemodynamic shift” resulting when an individual makes a positional, or orthostatic, change has
been impacted in some way, leading to feelings of dizziness and lightheadedness plus other
symptoms. Johnson at 78. Thus, a claimant alleging a vaccine injury of POTS is arguing that the
relevant vaccine has done something to the autonomic system sufficient to cause this chronic
response to orthostatic change. There should, therefore, be some evidence in this case that a
vaccine could accomplish this – whether in general, or specifically with respect to the Petitioner
herself.

II. Petitioner Has Not Satisfied her Burden of Proof

I am addressing the three Althen prongs in order of their importance to my decision, rather
than in their numeric order.

A. The Timeframe for Petitioner’s POTS Onset was not Medically Acceptable (Althen
Prong Three)

In evaluating if Petitioner’s alleged POTS began in a medically acceptable timeframe, I
must first determine when the records suggest it most likely began. Based upon the medical record
and the competing expert interpretations of it, I find that the record does not contain persuasive
proof of symptoms that could be associated with POTS before November 2012 – 21 months after
Petitioner’s HPV vaccination. As Dr. Mack noted (based on his established record treating
individuals with orthostatic problems like POTS), the February 2013 record of Petitioner’s visit
with Dr. Burris is the strongest evidence in the record of any time when she complained of enough
POTS-associated symptoms (dizziness when standing up, weakness) that it could be reasonably
concluded that she might have the condition. Because this record suggests this collection of
symptoms had been ongoing for three months, onset can be placed in November 2012.

The record in the almost two-year period prior to that time, by contrast, is not suggestive
of POTS. Rather, Ms. Johnson experienced either symptoms that are distinguishable (ptsosis),
associated with an entirely different disease that she did not in fact suffer from (myasthenia gravis),
or generalized symptoms, such as fatigue, that are too nonspecific to attribute to orthostatic
intolerance. The symptoms that caused her to visit the doctor in March and May 2011 cannot
credibly be deemed to be POTS-related, but instead reflect what the records say: that Petitioner

35
was suffering at the time from URIs of varying intensity, one severe enough to be diagnosed as
bronchitis and to encourage treaters to perform a chest x-ray. These records do not reflect POTS
symptoms - and Dr. Shoenfeld’s strained efforts to argue that I should interpret them to the
contrary, reading “cough” to mean “shortness of breath,” when the latter was explicitly denied,
were completely unpersuasive.

Taking the above into account, I can evaluate whether Petitioner’s onset was medically
appropriate. Petitioner’s causation theory (assuming for the moment that it is reliable and/or
supported by preponderant evidence) proposes that the HPV vaccine caused an autoimmune cross-
reaction resulting in POTS. Dr. Mack allowed that the biologic process resulting in an autoimmune
disease would occur within six months at most; Dr. Shoenfeld was far less constrained in proposing
what a reasonable onset would be, but primarily maintained that Ms. Johnson’s POTS began within
two months of the vaccine’s receipt – something my fact determination precludes. But this record
does not even support the conclusion that six months from the date of receipt of the vaccine (or by
August 2011) Ms. Johnson was experiencing any symptoms reflective of POTS. There is only
medical record evidence suggesting that Petitioner might have been experiencing shortness of
breath associated with strep throat (and thus another upper respiratory problem). Thus, the medical
record would not support even Dr. Mack’s admission for a possible maximum onset timeframe.31

Dr. Shoenfeld did not otherwise successfully establish that an even longer timeframe could
be medically acceptable. First, I do not find persuasive his suggestions that POTS develops in a
gradual or progressive manner (even though I do accept both experts’ contention that it can be
difficult to diagnose, and hence some delay from onset to diagnosis is to be expected), thereby
allowing for a long temporal period in which symptoms accumulated. Dr. Mack was persuasive in
establishing the contrary. Second, as I have stated in other cases in which Dr. Shoenfeld so argued,
to allow virtually any amount of time that passes from vaccination to onset to be deemed medically
appropriate would subvert the very purpose of this causation evidentiary element. See, e.g., Garner
v. Sec’y of Health & Human Servs., No. 15-063V, 2017 WL 1713184, at *16-17 (Fed. Cl. Spec.

31
Mr. and Mrs. Johnson did provide unrebutted testimony that beginning in the summer of 2011 and then thereafter,
they increasingly noticed that Petitioner exhibited greater and greater exercise intolerance. But without complaints of
parallel symptoms more closely associated with POTS – most notably dizziness on standing up – and because I do not
otherwise find that POTS would progress as argued, with symptoms building upon each other, I do not conclude that
Petitioner’s instances of exercise intolerance allow for an onset determination earlier than Dr. Mack’s proposal.

36
Mstr. Mar. 24, 2017), mot. for review den’d, 133 Fed. Cl. 140 (2017); see also Hennessey v. Sec'y
of Health & Human Servs., 91 Fed. Cl. 126, 142 (2010) (rejecting Dr. Shoenfeld’s attempt to
satisfy the third prong by positing that any timeframe is appropriate). Yet Dr. Shoenfeld implied
this is his actual view. Tr. at 32-33. This position lacks sufficient scientific support for it to be
deemed reliable, and therefore it does not aid Petitioner herein in arguing that the timeframe for
her onset was medically appropriate.

B. Petitioner Has Not Offered a Reliable Causation Theory (Althen Prong One)

As noted above, Petitioner has offered extensive amounts of medical and scientific
literature to support her claim, and also employed an expert with a strong background in
autoimmune and immunologic matters. And she includes components within her theory that are
routinely deemed valid in Vaccine Program cases, such as the mechanism of molecular mimicry
to explain how the protein components of a vaccine could cause an autoimmune cross-reaction.
Nevertheless, I do not find that the theory proposed in this case is sufficiently reliable, or
bulwarked in crucial places by reliable evidence, to find in turn that it has been established by
preponderant evidence.

First, Petitioner has not offered adequate evidence supporting the contention that any
association exists generally between the HPV vaccine and POTS. She relies heavily on articles
involving case studies in which a temporal correlation was observed between receipt of the HPV
vaccine and POTS, or comparable kinds of orthostatic intolerance. See, e.g., Ozawa; Kinoshita;
Brinth; Blitshteyn. But it is well recognized in the Program that while case studies are evidence
that should be considered as part of a special master’s overall entitlement determination, they are
not necessarily probative of causation, and for that reason do not in most instances merit significant
weight. 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). Dr. Mack convincingly explained in particular why many of the items of literature that
relied on such case study data were untrustworthy – the studied subjects voluntarily had sought
treatment for their orthostatic symptoms, making the studied group too self-selected to draw
conclusions from correlations observed with respect to that population. See Evanson v. Sec’y of

37
Health & Human Servs., No. 90-775V, 1991 WL 179085, at *4 (Fed. Cl. Spec. Mstr. Aug. 28,
1991) (suggesting “major methodological problems” exist with studies relying on self-reporting).
He also reasonably proposed that any association observed between HPV vaccine recipients and
POTS was attributable to the fact that young women were both the population most likely to
develop POTS and the population most likely to receive the HPV vaccine – rendering any
association between the two (not otherwise supported by a proper scientific experiment with
reliable controls) the product of chance.

Dr. Shoenfeld’s personal expertise could not fill in this evidentiary gap. He has written
extensively on the pathologic capacities of different vaccines, but has not been shown to possess
particularized knowledge of the autonomic nervous system or orthostatic intolerance conditions,
whether from a clinical practice or research. I listened to his testimony and, given his demonstrated
immunologic credentials, considered it carefully – but I did not find it to be credible simply
because it came out of his mouth.32

The alleged autoimmune nature of POTS is also a notably deficient element of Petitioner’s
case. Here – as in many vaccine injury claims – the Petitioner seeks to establish that the implicated
vaccine has initiated an injurious autoimmune process. It is undeniable that autoimmune diseases
have been associated with many vaccines, and many severe or alarming symptoms are attributable
to, or associated with, autoimmune diseases. See, e.g., Lozano v. Sec’y of Health & Human Servs.,
No. 15-369V, 2017 WL 3811124 (Fed. Cl. Spec. Mstr. Aug. 4, 2017). But the Petitioner cannot
prevail simply by arguing that other petitioners successfully established that the disease or
condition they experienced has been shown to be autoimmune, and therefore the same is plausible
here.

The evidence that POTS is in all instances, or even the majority of instances, autoimmune
was fairly thin. Petitioner did have Dr. Shoenfeld’s support for the contention, and his expertise in
studying autoimmunity entitles his opinion to some weight (although that opinion was
simultaneously undermined by his lack of experience studying or treating POTS). In addition, Dr.

32
In other Program cases, Dr. Shoenfeld has advanced the broad opinion that virtually any autoimmune illness or
disease could be vaccine-caused – a sweeping view that lacks reliability, at least based on present science. See, e.g.,
Hennessey v. Sec’y of Health & Human Servs., 91 Fed. Cl. 126, 135 (2010) (rejecting Dr. Shoenfeld’s theory that
“every vaccine can potentially cause an autoimmune disease” as “so broad as to be meaningless”) (internal quotation
marks omitted)).

38
Mack did not categorically deny that POTS could ever be autoimmune in nature. However, the
circumstances in which the condition might be autoimmune appear extremely limited - i.e., where
an individual possesses a specific ganglionic autoantibody - are inapplicable in this case (as
Petitioner was not shown to possess that autoantibody), and otherwise have not been shown
applicable to the form of POTS suffered in this case. The literature filed in the case better supports
the conclusion that POTS is more commonly not autoimmune in origin.33

In addition, Dr. Mack referenced reliable and credible epidemiologic evidence, like Chao,
that further weakened Petitioner’s contention that the HPV vaccine has been associated with any
autoimmune illnesses. I have often had the occasion to consider Chao in cases involving the HPV
vaccine, and I deem it a probative, persuasive piece of evidence that is not diminished in reliability
merely because it was funded in part by a pharmaceutical company. See Sullivan v. Sec’y of Health
& Human Servs., No. 10-398V, 2015 WL 1404957, at *11-12 (Fed. Cl. Spec. Mstr. Feb. 13, 2015).
While it is true that petitioners are not obligated to offer epidemiologic evidence to support their
claim, it can be considered (especially when it exists and is especially relevant to the causal theory
at issue) in evaluating the success of a Vaccine Act petitioner in meeting her evidentiary burden.34
Here, such evidence was not effectively rebutted.

33
I also note that some of the foundational support for the contention that POTS can be autoimmune has been called
into question. In a recent Vaccine Program matter before me also involving POTS and the HPV vaccine, one of Dr.
Mack’s Mayo Clinic colleagues, Dr. Philip Low – a neurologist with a deep background in autonomic disease, and a
foremost authority on the topic as well as orthostatic intolerance more generally – testified as an expert. In so doing,
Dr. Low spoke about Thieben (which he co-authored), and the views expressed therein regarding the possibility of an
autoimmune association for some cases of POTS. See Combs v. Sec’y of Health and Human Servs., No. 14-878, slip.
op. (Fed. Cl. Spec. Mstr. Feb. 15, 2018). Dr. Low opined that the association (based on the same ganglionic
autoantibodies testified to by Dr. Shoenfeld) had not been borne out by subsequent research, and in fact he regretted
it had even been mentioned in Thieben (an article cited by Petitioner and which many of the other items of literature
she cited relies upon), since it misled treaters into placing undue emphasis on testing for the presence of the
autoantibody when evaluating POTS. Combs at 17-18.

34
Petitioners in Program cases, when confronted with strong epidemiologic evidence, are often quick to retort that
they cannot be “required” to offer it as part of their evidentiary showing – and therefore merely to consider it
constitutes an unfair heightening of their evidentiary burden. See D’Toile v. Sec’y of Health & Human Servs., 132
Fed. Cl. 421, 430 (2017), appeal docketed, No. 17-1982 (Fed. Cir. May 4, 2017). But this conflates what evidence a
petitioner must offer to prevail with what a petitioner must do in rebutting such evidence - when it exists. Petitioners
can obtain entitlement without ever resorting to epidemiologic evidence, and there are many circumstances where that
category of evidence could be shown as not deserving of substantial weight (for example, epidemiologic evidence that
the flu vaccine is mostly safe would not rebut equally reliable scientific evidence that the flu vaccine has been
associated with rare illnesses, like certain peripheral neuropathies). But sound and reliable epidemiologic evidence
that bears on a vaccine injury claim cannot be swept under the carpet with the argument that it is categorically
irrelevant.

39
 Moreover, even if I found that the autoimmune character of POTS had been established in
limited circumstances, Dr. Shoenfeld’s overall opinion remains unreliable from a scientific and
medical standpoint. Dr. Shoenfeld repeatedly made clear that his causation opinion also depended
on additional points: (a) theoretical homology between components of the HPV vaccine for
molecular mimicry to be a reasonable mechanism explaining how the HPV vaccine could cause
an autoimmune reaction resulting in POTS, (b) the existence of a positive ANA titer level as
indicating a susceptibility to autoimmune conditions, and (c) the fact that Petitioner ultimately
received a POTS diagnosis. Tr. at 40-41, 133-34. But each of these additional points was
inadequately established, in different ways.

Regarding homology and molecular mimicry, I acknowledge that claimants need not
establish a specific biologic mechanism to prevail, and also that the mechanism of molecular
mimicry has been accepted in numerous Program cases to explain how an autoimmune process
can work. Nevertheless – Petitioners cannot simply invoke the concept of molecular mimicry and
call it a day. See Devonshire v. Sec’y of Health & Human Servs., No. 99-031V, 2006 WL 2970418,
at *15 (Fed. Cl. Spec. Mstr. Sept. 2006), aff’d, 76 Fed. Cl. 452 (2007). Rather, they need to offer
reliable and persuasive medical or scientific evidence of some kind (whether expert testimony or
literature) that suggests the vaccine components could interact with self structures as maintained.
Here, all Petitioner has done is observe that protein sequences contained in the HPV vaccine can
be shown to possess some sequential and/or structural similarity with proposed targets of where
the autoimmune reaction resulting in POTS is speculated to occur – not evidence that (a) the HPV
vaccine has been established to so perform, or (b) that reliable science has demonstrated that any
kind of external insult, whether viral or vaccine, would produce a reaction resulting in POTS at
the proposed locus. Tr. at 136-38. There is thus a missing, but vital, link to this aspect of
Petitioner’s theory.

The existence of a somewhat positive ANA level is an even more attenuated consideration
in favor of Petitioner’s causation theory. Dr. Shoenfeld himself admitted that it alone was not
strong evidence supporting his theory. Tr. at 41. But ANA levels are not even directly associated
with POTS – and the autoantibodies that arguably are, such as the ganglionic antibodies referenced
in Thieben, were never detected in this case. Rather, as Dr. Mack established, ANA levels are most
directly relevant to whether an individual has a rheumatologic disease, like lupus – a disease not

40
at issue herein. And individuals can possess positive ANA titers and not experience an autoimmune
disease. In effect, Dr. Shoenfeld is conflating all autoimmune conditions, and the biomarkers
associated therewith, as comparable and interchangeable.35

Finally, Dr. Shoenfeld’s theory, by his own admission, was heavily dependent on the mere
fact of Petitioner’s diagnosis. This, however, is the definition of the kind of circular reasoning –
injury being cited as proof that the vaccine could cause that injury – that has often been rejected
in other cases. See, e.g., Holmes v. Sec’y of Health & Human Servs., No. 08-185V, 2011 WL
2600612, at *14 (Fed. Cl. Spec. Mstr. Apr. 26, 2011), aff’d, 115 Fed. Cl. 469 (2014). It is no more
persuasive here.

C. Petitioner Has Not Demonstrated her POTS was Vaccine-Caused (Althen Prong
Two)

A threshold question presented under the “did cause” Althen analysis is whether Ms.
Johnson had POTS at all. Although Dr. Mack disputes the diagnosis, I find that it is supported by
preponderant evidence. Dr. Blitshteyn is a qualified neurologist with an interest in POTS (at least
as reflected in her publications) comparable to that of Dr. Mack. Although she did not formally so
diagnose Petitioner, she strongly suggested a POTS diagnosis would be appropriate, and she did
so on the basis of several years of medical records. What is more, the results of the tilt table test
that I requested Petitioner undergo were mostly supportive of the diagnosis, Dr. Mack’s criticisms
notwithstanding. Although a more reliable and complete diagnosis might be preferable (for
example, one made by a treater who saw Ms. Johnson in person, and closer in time to when the
symptoms began), the diagnosis herein has enough evidentiary support to find that it meets the
preponderance test.

The overall record does not, however, contain preponderant evidence that the HPV vaccine

35
Dr. Shoenfeld also could not help but allude to the ASIA theory in arguing for the importance of the vaccine adjuvant
in inducing the alleged autoimmune reaction. See, e.g., Tr. at 19-20 (“[t]he adjuvant, per se, in someone who is at risk
of developing autoimmune disease, can induce autoimmunity”). I had previously warned Dr. Shoenfeld to steer clear
of this as a component of his causation theory, and for good reason: similar ASIA theories have repeatedly been found
to be unpersuasive by other special masters, because the theory is (at a minimum) too preliminary or unreliable based
on present science. See, e.g., Rowan v. Sec’y of Health & Human Servs., No. 10-272V, 2014 WL 7465661 (Fed. Cl.
Spec. Mstr. Dec. 8, 2014); mot. for review den’d, 2015 WL 3562409 (Fed. Cl. 2015); D’Angiolini v. Sec’y of Health
& Human Servs., No 99-578V, 2014 WL 1678145 (Fed. Cl. Spec. Mstr. Mar. 27, 2014), mot. for review den’d, 122
Fed. Cl. 86 (2015).

41
caused Petitioner’s POTS via the proposed autoimmune process. The medical record does not
support the conclusion that the HPV vaccine had any deleterious effect on Ms. Johnson within
even eighteen months of receipt. Rather, she had several URIs with associated symptoms that later
resolved, or unrelated problems (ptosis, suspected myasthenia gravis) that are not reasonably
linked to her subsequent POTS diagnosis. There is certainly little evidence in 2011 or 2012 that
Petitioner was experiencing any of the hallmarks of an autoimmune disease, like inflammation,
and the fact that she was positive for certain autoimmune markers (for example, her slightly
elevated ANA levels) cannot be leveraged into a finding that she was beginning to experience
POTS – especially since she has not been shown to possess the autoantibodies that (at least at one
time) have been deemed to be potentially associated with POTS. And the anecdotal evidence that
Petitioner’s family members had experienced autoimmune illnesses, and/or that Petitioner herself
was at certain points considered to be experiencing one (myasthenia gravis in particular) does not
establish preponderant proof that she did actually have some genetic risk (and indeed Dr.
Shoenfeld admitted he could not even identify what the relevant genetic marker might be for POTS
(Tr. at 135)). Thus, even if Dr. Blitshteyn’s 2015 diagnosis is unassailable, the evidence of
Petitioner’s course from February 2011 to the time she first displayed POTS-related symptoms in
late 2012 does not reflect a vaccine-induced condition.

Dr. Shoenfeld’s testimony in interpreting Petitioner’s medical records on these matters was
especially unpersuasive. He repeatedly argued with treater findings, attempting to twist self-
evident record notations (such as the fact that the Petitioner reported she had a cough in March
2011) into evidence of “shortness of breath” that was in fact a harbinger of POTS. Although
experts can successfully dispute the accuracy of treater notes, or provide persuasive alternative
interpretations based on facts gleaned from contemporaneous records or their own experience, Dr.
Shoenfeld’s argumentative approach was ineffective. He was also unsuccessful in proposing that
POTS was a progressive condition that would unfold over time, as allegedly occurred in
Petitioner’s circumstances. Although ample evidence offered in this case supports the conclusion
that it can take treaters some time to diagnose POTS, Dr. Mack was more persuasive in explaining
that POTS does not unfold or develop progressively. If Petitioner had been suffering from POTS
as early as she alleges, the record should have more evidence of symptoms classically associated
with it – but it does not.

42
 Overall, the medical record and other evidence does not preponderate in favor of the
conclusion that (assuming POTS is autoimmune in Petitioner’s case) the HPV vaccine had
anything more than a remote temporal association with the onset of her POTS-associated
symptoms – not enough for entitlement.

CONCLUSION

The Johnson family’s demonstrated efforts to identify a cause for Petitioner’s condition,
and to take the best care of her possible, are laudable. But the record does not support Petitioner’s
contention that the HPV vaccine caused her to develop POTS, 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.36

IT IS SO ORDERED.

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

36
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.

43