Hughes v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-930V
(to be published)

*************************
KIRA HUGHES, * Chief Special Master Corcoran
*
*
Petitioner, *
* Filed: January 4, 2021
v. *
* Dismissal without hearing;
SECRETARY OF HEALTH AND * HPV vaccine; POTS;
HUMAN SERVICES, * Chronic Regional Pain Syndrome;
Expert qualifications; Causation
*
* Respondent.
*
*************************

Braden Blumenstiel, DuPont and Blumenstiel LLC, Dublin, OH, for Petitioner.

Kyle Pozza, U.S. Dep’t of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION 1

On August 3, 2016, Patrice Moczek filed a petition seeking compensation under the
National Vaccine Injury Compensation Program (the “Vaccine Program” 2), on behalf of her then-
minor daughter, Kira Hughes. (Ms. Hughes became the Petitioner after she turned 18). In the
Petition, Ms. Hughes alleges that the human papillomavirus (“HPV”), meningococcal, and tetanus
diphtheria-acellular-pertussis (“Tdap”) vaccines that she received on August 15, 2013, caused her

1
This Decision will be posted on the United States Court of Federal Claims’ website in accordance with the E-
Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to anyone with access
to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published
Decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party
has fourteen (14) 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 entire Decision will be available to the public in its current form. Id.
2The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”).
All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.
to suffer from leg pain, headaches, and fatigue, among other things. See Petition (“Pet.”) at 1. She
has since refined her claim, arguing that she experienced complex regional pain syndrome
(“CRPS”) and/or postural orthostatic tachycardia syndrome (“POTS”) specifically due to the HPV
vaccine. See Petitioner’s Response to Respondent’s Motion for Order to Show Cause, filed on Jan.
13, 2020 (ECF No. 75) at 5, 7.

After appellate practice occasioned by Petitioner’s failure to meet scheduling deadlines
was resolved, and then some intervening back-and-forth between the parties, I invited Respondent
to seek dismissal of the case based solely on the filed record and expert reports. Motion for Ruling
on Record, dated May 7, 2020 (ECF No. 81) (“Mot.”). Petitioner has reacted to the motion, making
it now ripe for resolution. Petitioner’s Memorandum Contra to Respondent’s Motion for Ruling
on The Record, dated August 21, 2020 (ECF No. 86) (“Opp.”).

Although Respondent moves for dismissal of this case without ever having filed any expert
reports of his own, I find his motion is well-taken and appropriately granted. As discussed in
greater detail below, even after the filing of multiple expert reports, Petitioner cannot meet her
preponderant burden of proof, making a hearing unnecessary. The present record does not allow
the conclusion that it is more likely than not the nonspecific symptoms she did experience (certain
of her alleged injuries, such as POTS and CRPS, are not bulwarked with preponderant evidence)
were vaccine-caused—or that the HPV vaccine could cause them. I have now repeatedly heard
claims arguing that the HPV vaccine causes a variety of similar injuries, and no arguments made
herein were any more persuasive, or reliably established, than those prior cases in which I
(similarly) denied entitlement. Indeed—the experts offered to substantiate Petitioner’s theory
herein were especially unpersuasive or unqualified to offer the opinions they embraced.

I. Medical History

Relevant Pre-Vaccination Events

Ms. Hughes (who was close to 13 years old when she received the vaccines at issue) had
some prior medical history events bearing on her claim. Ms. Hughes reports previously
experiencing (among other things) ovarian cysts, heavy menses, occasional back pain, and multiple
urinary tract infections (“UTI”). Ex 1 at 6. She also had some emergency treater visits that parallel
certain of her post-vaccination treatment incidents. For example, on November 27, 2012
(approximately nine months prior to the vaccinations in question), Petitioner was seen at Wheeling
Hospital in Wheeling, West Virginia, for “problems with breathing, high heart rate, SOB
[shortness of breath], dizzy feeling,” and she reported at this time a family history of anxiety
(which treaters settled on as explanatory after a normal EKG). Ex. 2 at 5.
A month later, on December 10, 2012, Ms. Hughes saw a physician’s assistant at Clay-
Battelle Community Health Center in Blacksville, West Virginia, complaining of three days of
dizziness, two weeks of headache, and heavy menstrual periods for two months. Ex 1 at 20. Blood

2
 testing, however, produced normal results, and Petitioner was assessed only with general
“dizziness,” which was thought possibly to be the product of an inner ear or optical issue. Id. at
19, 22. Then, on January 4, 2013, Petitioner went to a different treater, reporting bruising
following a fall and associated knee pain. The history indicated that patient had a left patella
subluxation which spontaneously reduced one-to-two years prior, and she was referred for
physical therapy in association with this knee problem. Ex. 1 at 15 –16.

Vaccinations and Purported Symptoms Onset

On August 15, 2013, Petitioner went back to the physician’s assistant she had seen in
December 2012 at Clay-Battelle Community Health Center for “immunization need.” Ex. 1 at 6.
The medical record of this visit indicated a history of “migraines.” Id. Ms. Hughes received the
Meningococcal, Tdap, and HPV vaccines that she alleges were causal of her subsequent medical
issues. Id. at 7. There is no evidence in the record of any immediate reaction to these vaccines—
although within a week of their receipt, Petitioner returned to Clay-Battelle Community Health
Center on August 21, 2013, with “complaints of a urinary tract infection,” along with purported
flank pain and occasional nausea for the prior two days. Ex. 1 at 4. On exam, she displayed mild
generalized abdominal tenderness, but her lower extremities were described as not tender, and she
largely appeared to be comfortable and pain-free. Id. at 3. Based on the conclusion that she was
experiencing another UTI, Ms. Hughes was prescribed an antibiotic and underwent a urine culture
that subsequently came back negative. Id. at 5.

Two days later (now eight days post-vaccination), on August 23, 2013, Petitioner was seen
by Cynthia Walsh, M.D. (an obstetrics and gynecology specialist) for unspecified lower
abdominal pain that she reported had begun four days prior, adding that her menses had started
the day before vaccination and was still causing some spotting. Ex. 24 at 8. Her exam was
unremarkable (including a pelvic ultrasound, which ruled out another cyst as explanatory), and
the assessment merely noted that Ms. Hughes had (within a period of days) twice reported
abdominal pain during menses. Id. at 9. The following month (September 2013), she returned to
Dr. Walsh and was assessed with dysmenorrhea (cramping and pain associated with
menstruation) and prescribed a low-dose oral contraceptive to help limit the symptoms. Id. at 6–
7.

October 2013 Symptoms

Ms. Hughes’s treatments and emergency care doctor’s visits greatly increased in October
2013, although even by this time (seven to nine weeks post-vaccination) no medical professionals
had proposed any connection between her symptoms and the vaccines she had received nearly
two months prior. Petitioner alleges, however, that immediately following receipt of the HPV
vaccine in August 2013, she experienced pain in her arm that was so severe that once she got

3
 home, she felt like she was going to pass out. Affidavit of Kira Hughes at 2, filed on Jan. 26,
2018 as Ex. 46 (ECF No. 54-4) (“First Hughes Aff.”). She described her arm as “swelled [sic]
and [] mottled,” and recalls crying for four hours straight because of pain. First Hughes Aff. at 2.
Petitioner’s mother also alleges that Ms. Hughes experienced very similar immediate symptoms
to what Petitioner described, adding that soon after vaccination, her daughter also began
complaining of severe abdominal pain and back pain. Affidavit of Patrice Moczek at 3, filed on
Jan. 26, 2018 as Ex. 45 (ECF No. 54-4) (“Moczek Aff.”). Ms. Moczek goes on to allege that over
the next few weeks (following vaccination), her daughter’s “symptoms progress[ed] and she
became mostly bedridden with pain and fatigue.” Moczek Aff. at 3. She added that “[i]t seemed
every other day a new symptom was being added to the myriad already existing.” Id. As already
noted, however, the contemporaneous medical record does not corroborate these contentions
(although it does reveal Petitioner reported abdominal pain deemed by treaters to be associated
either with a UTI or menses).

On October 16, 2013, Petitioner returned to Dr. Walsh, now complaining of bilateral “leg
pain,” which she stated had begun three days before. Ex. 24 at 3. To assess a possible etiology
for this pain, it was proposed that Petitioner undergo a Doppler study of her lower legs (Id.)—
but the study revealed no evidence of any deep vein thrombosis. Id. at 5; Ex. 4 at 4. Two days
after (October 18, 2013), however, Ms. Hughes went to the Monongalia General Hospital
emergency department in Morgantown, West Virginia, reporting “leg cramping since the
weekend,” as well as headache and back pain. Ex. 7B at 16. But after all testing and x-ray imaging
produced normal results, her treaters proposed that her symptoms were attributable to “myalgia;
growing pains,” and it was recommended that she receive an over-the-counter pain medication.
Id. at 20.

Petitioner continued thereafter to report ongoing symptoms similar to those she had
complained of at these two care visits. A few days after her ER visit, Ms. Hughes was seen by
Joseph Li, M.D., on October 22, 2013, reporting leg pain for ten days. Ex. 3 at 5. She specifically
described the pain as worse in the morning, associated at times with limping, and although it
could occur in her back was generally more intense in her legs. Id. She denied, however, any
associated weakness, numbness, or sensation changes, and also reported that she had ceased
taking the contraceptive that Dr. Walsh had prescribed. On exam, Petitioner reported tenderness
in her lower extremities when touched, and testing revealed slightly elevated muscle enzyme
levels (which could be suggestive of muscle injury), 3 but she tested negative for Lyme disease
and revealed a normal rheumatoid factor. Id. at 8; Ex. 7B at 7 –11. Ms. Hughes was diagnosed
with a nonspecific myalgia, and prescribed a muscle relaxant. Ex. 3 at 9.

3 Aldolase, a muscle enzyme, is used in the glycolytic breakdown of glucose. Mosby’s Manual of Diagnostic and

Laboratory Tests 41 (6th ed. 2018). Elevated aldolase levels are seen in patients with primary muscular disorders, and
thus testing for it is useful for identifying muscular or hepatic cellular injury or destruction. Id.

4
 A week later, on October 29, 2013, Petitioner saw another treater on referral from Dr.
Li for the recent leg pain she had been experiencing that month. Ex. 6A at 4. She reported that
the pain was worse with walking, her left leg was weaker than her right, but that her ER visit
had produced a “growing pains” diagnosis. Id. at 8. 4 Petitioner underwent a CT scan of her
lumbar spine, plus more lab testing, but all results were normal. Id. at 14 –15. In addition, a
physical exam revealed inconsistent results, with “indirect” observation of the Petitioner (in
terms of strength, sensation, and range of motion) suggesting less problems than when she was
directly being examined. Id. at 8. Indeed, the physician treater also noted in the record from this
visit that Ms. Hughes generally seemed cheerful and unconcerned by the complained-of
problems. Id. Thus, although evaluating treaters who saw Petitioner at this visit initially
proposed that Petitioner’s leg pain complaints could be a function of a neurologic or
musculoskeletal disorder, it was ultimately concluded that her inconsistent complaints made it
difficult to identify a proper diagnosis. Id. at 6, 9. 5 As a result, treaters decided to admit
Petitioner for further evaluation and testing. Id. at 15.

On October 29, 2013, Ms. Hughes was admitted to the West Virginia University
Hospital in Morgantown, West Virginia, by Jeffrey Lancaster, M.D. Ex. 6A at 11. On exam, she
again revealed multiple areas of abdominal, back, and lower extremity tenderness, leading
treaters to characterize her presentation as “multiple vague complaints,” with no evidence of an
acute inflammatory disorder that might explain her symptoms. It was noted that Petitioner’s
symptoms might qualify as fibromyalgia, but treaters added that her young age made that
diagnosis unlikely. Id. at 15. The records from this admission also indicate that Ms. Moczek
again speculated that Petitioner’s receipt of the HPV vaccine explained her symptoms, although
treaters pushed back against that supposition. Ex. 6A at 16, 19.

In the course of Petitioner’s hospitalization, a variety of diagnostic possibilities were
explored. Inflammatory myopathy and malignancy were ruled out, along with an Epstein-Barr
viral infection or Lyme disease (given negative testing results), and although a post-viral myalgia
syndrome was deemed possible, it was considered difficult to confirm by testing. Ex 6A at 23.
Hospital treaters again gave no credence to the possibility (raised by Ms. Moczek) that the HPV
vaccine might be causal, urging Petitioner’s family instead to consider a brain MRI to rule out
multiple sclerosis (a proposal the family initially rejected). Id. at 23, 26 –27. Anxiety, however,

4In addition, Ms. Moczek informed the treater at this time of her nascent view that Ms. Hughes’s symptoms had begun
after, and were possibly associated with, her receipt of the HPV vaccine in August earlier that year. Ex. 6A at 4.
5
During this October 29, 2013 emergency room visit, Petitioner was seen by multiple treaters who had slightly varying
opinions. See Ex. 6A at 3-16. Treater Monica Shaffer’s recorded impression, for example, was of concern for
musculoskeletal disorder, neurological disorder, or other etiology. Id. at 5. An attending note by Dr. Anna Marie Scott
said that Petitioner had already been seen by multiple physicians, was referred here for pediatric neurology, and that
inconsistent exam made differential difficult. Id. at 8. And Dr. Jeffrey Lancaster (the physician who ultimately
admitted Petitioner to the hospital) raised the possibility of fibromyalgia. Id. at 14.

5
was given a “high likelihood” as explanatory, in light of the nonspecific overall nature of
Petitioner’s complaints and the lack of objective lab or exam findings that would substantiate
them. Id. at 23, 27.
On October 31, 2013, Ms. Hughes had a consultation with neurologist Jodi Lindsey,
M.D., to rule out a neurologic etiology for her complaints. Petitioner summarized for Dr.
Lindsay her overall course of symptoms (leg and back pain, fatigue, headaches, jaw pain,
constipation, bad menstrual cramps, night sweats, dizziness/tunnel vision when getting up too
fast, etc.), and Ms. Moczek repeated her suspicions regarding the HPV vaccine. Ex. 6A at 28.6
On exam, Ms. Hughes had “giveaway weakness” in her left lower extremity, with slight
hyperreflexia in the lower extremities as well. Id. at 29. The assessment was “[n]o true weakness
but give-away weakness” and “[m]ajority of symptoms might be related to chronic
constipation.” Id. at 32. Dr. Lindsey ordered an MRI of the lumbar spine, but it showed only
some minor disc bulging deemed unlikely to cause her symptoms, and all other lab testing
produced “unremarkable” results. Id. at 24, 33.

Petitioner was discharged on November 1, 2013. Ex. 6A at 36. Dr. Lancaster’s discharge
summary observed that there was “no clear etiology” for Petitioner’s complained-of symptoms,
given that the entirety of her work-up (which included evaluations for neuropathic,
rheumatologic, malignant and musculoskeletal causes) had produced normal findings. Id.
Anxiety was again proposed as possibly explanatory—despite rejection of that diagnosis by Ms.
Hughes’s family, and their continued view that her symptoms instead arose from the HPV
vaccine. Id. A brain MRI was once again recommended. Id. On November 4, 2013, Ms. Hughes
underwent a brain and spine MRI which were “[a]ll normal except the MRI of the spine read as
subtle loss of height of disc space at L4-5 level.” Ex. 3 at 11.

About a week after her discharge, on November 6, 2013, Ms. Hughes went back to Dr.
Li for a follow-up. Dr. Li’s history from this visit notes the “[g]eneral consensus” that no physical
explanation for Petitioner’s symptoms had been identified. Ex. 3 at 16. Dr. Li, however,
specifically observed at this time disparities between Petitioner’s complained-of symptoms and her
conduct during the exam. For example, Ms. Hughes moved “without difficulties” while in Dr. Li’s
office, although on departure “her gait was unsteady and stiff when she left.” Id. at 13. In
addition, in order to be examined she easily removed her tightly-fitting jeans with no reaction or

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A November 1, 2013, a spiritual care note from Kristen Taylor of West Virginia University Hospitals indicates that
Petitioner’s family expressed frustration that their concerns about the HPV vaccine’s possible role in her symptoms
(especially given their ambiguity) were not being taken seriously by treaters, noting that based on their own research,
“every one of [Petitioner’s] symptoms matches up with these bad reactions,” and setting forth their intent to pursue
the matter independently once Petitioner was discharged. Ex. 6A at 83, 84.

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expressions of pain to her legs, yet in response to light touching associated with Dr. Li’s exam
she expressed severe pain—then clothing herself thereafter with no apparent discomfort. Id. 7
At this time, Petitioner otherwise continued to complain of symptoms comparable to
what she had previously reported, including “malaise and anorexia,” gastrointestinal
“cramping,” “myalgias and stiffness,” “weakness,” mild back pain, and anxiety associated with
the aforementioned symptoms. Ex. 3 at 12. Dr. Li offered the possibility that “somatization
disorder” 8 might explain Petitioner’s symptoms. Id. at 12, 16. In response, Ms. Moczek asked
again about whether the HPV vaccine could explain Petitioner’s symptom—a proposal Dr. Li
rejected, although he did not oppose Petitioner obtaining treatment from a practitioner of holistic
medicine. Id.
Treatment in 2014
In 2014, Petitioner and her family continued to seek an explanation for her constellation
of symptoms. The record from the time reveals additional physician determinations that Ms.
Hughes’s complaints were more likely attributable to a mental/cognitive problem—but also that
Petitioner and her family rejected such assessments, in favor of her family’s preferred view that
the HPV vaccine explained her symptoms, and that treaters of questionable competence were
sought to confirm that view.
Thus, on January 7, 2014, Petitioner had an outpatient neurology follow-up visit with Dr.
Lindsey, at which time all her hospitalization testing results (which had produced normal
results), plus the post-hospital assessment of anxiety, were considered in light of her ongoing
complaints. Ex. 6C at 29. As before, Ms. Hughes and Ms. Moczek expressed their belief that
Petitioner’s symptoms were the product of “an inflammatory process ongoing triggered by the
administration of the [HPV] vaccine,” and that her prior symptoms of headache, leg pain, etc.
continued, although these symptoms were alleviated by a diet recommended by a naturalist and
other vitamin supplements. Id.
Dr. Lindsey performed a neurologic exam which produced normal results and again
noted “no clear evidence for a myopathy or neuropathy,” as well as a lack of evidence of an

7
Dr. Li’s notes also mention Ms. Hughes’s stay-at-home status as of the beginning of November 2013 (since she now
had reportedly missed three weeks of school due to her symptoms). Ex. 3 at 16. In response to Dr. Li’s comments that
Petitioner could go back to school if she got better, she cried, objecting that she was “not pretending to be sick.” Id.
at 15. She also denied that her symptoms were the product of anxiety about school problems, but objected when Dr.
Li discussed “the possibility of somatization/conversion of her symptoms.” Id. at 11.
8
Somatization disorder is a mental disorder characterized by multiple somatic complaints that cannot be fully
explained by any known general medical condition or the direct effect of a substance, but are not intentionally feigned
or produced, beginning before the age of 30 and occurring over several years. Somatization disorder, Dorland’s
Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=71227&searchterm=somatization+disorder (last visited
October 20, 2020). Complaints comprise a combination of at least multiple pain symptoms, multiple gastrointestinal
symptoms, a sexual symptom, and a neurologic symptom. Id. They are often presented in a dramatic, vague, or
exaggerated way, with involvement of numerous physicians, numerous diagnostic evaluations, and unnecessary
medical treatment or surgery. Id.

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existing/ongoing inflammatory process. Ex. 6C at 32. Dr. Lindsey did not feel an EMG was
warranted, questioned Ms. Moczek’s contentions about the role the HPV vaccine had played,
and (like Dr. Li) proposed that treatment for somatization disorder was more appropriate. Id. Dr.
Lindsey also disputed that Petitioner revealed any clinical indicia characteristic of CRPS, and
suggested a management protocol to assist Ms. Hughes with headaches. Id.
Around the start of 2014 Ms. Hughes also began to see Dr. Phillip DeMio—a purported
specialist in treatment of Lyme disease and autism, and one of her three experts in this case—at
Whole Health & Wellness in Worthington, Ohio. 9 See generally Ex. 10A. The December 2013
intake form (which, like many of the records associated with Dr. DeMio is in scribbled
handwriting that is virtually impossible to decipher) indicates that Petitioner was experiencing
myalgias, headaches, and constipation, and provided some of her history (including receipt of
the HPV vaccine). Id. at 2 –3. Dr. DeMio also noted Ms. Moczek’s claim that Petitioner had an
“uneven smile” that could be suggestive of a “mild Bell palsy on the left side of her face.” Id. at
4. Dr. DeMio started the Petitioner on several vitamin and mineral supplements, and ordered
several labs to test for infection, metabolic disorders, hormone imbalance, myositis, heavy metal
toxicity and immunodeficiency.
Two months later, on March 19, 2014, Petitioner returned to Dr. Li, continuing to
complain of persistent pain that she reported began in October 2013 (two months after the
vaccinations at issue). Ex. 3 at 18. Ms. Moczek informed Dr. Li that Dr. DeMio had proposed
that Petitioner might have some kind of Lyme disease (although Dr. Li observed in response that
his own testing had been negative for Lyme disease) Id. Petitioner’s family also requested a
referral to a rheumatologist.
In reaction, and consistent with his observations from November 2013, Dr. Li again noted
the disparity between the persistent pain reported by Petitioner and her seemingly healthy
demeanor and conduct during the exam. Ex. 3 at 22. Dr. Li also attempted to reaffirm to
Petitioner’s family that the sum total of his prior work-up for Ms. Hughes was negative, and that
he did not see the need for the testing that Dr. DeMio had requested. Id. Diagnoses proposed by
Dr. Li after this visit included myalgia and somatization disorder, and he indicated that he would
refer Petitioner to a rheumatologist, although if such a specialist could not identify an
explanation for the complained course of symptoms, “then we really have to focus on getting
her psychiatric help.” Id. at 24.
On March 31, 2014, Ms. Hughes was seen in an adolescent medicine clinic at West
Virginia University Hospital by Ahmad Al-Huniti, MD for chronic pain in her back, legs, and
shoulders, plus headaches, fatigue, and sleep interference at night (which in turn was causing
her sleepiness during the day). Ex. 6C at 205 –12. Her 2014 visits to “Lyme specialist” Dr. DeMio
were noted. Id. at 207. Dr. Al-Huniti’s assessment recorded the presence of “multiple complaints

9
Dr. DeMio's website states that his practice focuses on medical testing and treatment for autism, AD/HD disorders,
and Lyme disease. See About Dr. DeMio, http://drdemio.com/dr-phillip-demio/ (last visited on October 20, 2020).

8
without clear etiology,” which he proposed “could be psychogenic or related to complex regional
pain syndrome, chronic fatigue syndrome, Ehlers-Danlos/POTS,” while also allowing that a
mental health origin could also be explanatory. Id. at 211. Dr. Al-Huniti proposed follow-up in
three weeks, but it is not evident from the record that this occurred.
On April 22, 2014, Ms. Hughes had her initial rheumatology evaluation at Nationwide
Children’s Hospital in Columbus, OH, by Bethanne Thomas, CPNP and Sharon Bout-Tabaku,
M.D. for “chronic fatigue and generalized pain”. Ex. 5 at 6. The HPV vaccine was again reported
by Petitioner and her family to have initiated Petitioner’s symptoms, although at this visit Ms.
Moczek described a more immediate onset of pain in August 2013, despite a lack of prior record
support for such assertions. Id. Treater impressions were benign hypermobility syndrome,
amplified musculoskeletal pain, and fatigue, and they recommended desensitization by
massaging areas of pain to help retrain her overstimulated nervous system. Id. at 67-68. They
noted that joint hypermobility as well as psychological factors can increase the risk of developing
amplified musculoskeletal pain, however, and thus also suggested treatment for anxiety. Id.
In the meantime, Petitioner underwent the testing proposed by Dr. DeMio, obtaining the
results at the end of April 2014. Ex. 10B at 13 –69. Such testing resulted in normal thyroid studies
(including negative thyroglobulin antibody), no evidence of Lyme disease, and negative
serologies for cytomegalovirus. Id. at 28 –32. Other studies, however, revealed elevated
Mycoplasma IgG and IgM antibodies, which were deemed suggestive of a current (reflected in
the IgM findings) or prior/resolved (for IgG) infection, with the IgG levels specifically positive
for Human Herpesvirus-6, although numerous other infectious diseases were ruled out. Id. at 33–
34, 35 –51. 10 In addition, no MTHFR mutation was observed, and Petitioner’s
estrogen/testosterone levels were normal. Id. at 43.
In early May 2014, Ms. Hughes was seen in a genetics clinic at West Virginia University
Hospital by Tara Narumanchi, M.D. for “joint hypermobility and chronic pain” and assessment
for any possible genetic etiology. See generally Ex. 6C at 222 –27. But following examination,
Dr. Narumanchi proposed that there was no need for further testing. Instead, she recommended
physical therapy (hydrotherapy), plus a pediatric cardiology evaluation with a tilt table test “due
to concern of POTS,” although is not evident from this record (other than Petitioner’s mother
expressing concern to treaters) why POTS was considered at all (beyond the fact that POTS had

10 “Immunoglobulin G (IgG) and Immunoglobulin M (IgM) are antibodies produced in response to infection, and their
titer levels can help monitor or detect immune deficiencies. IgM is an indicator of current infection, while IgG reflects
exposure to a past infection. Increased levels of IgG or IgM are indicia of hepatic diseases (including connective tissue
diseases and acute/chronic infections), while decreased levels are found in patients with primary/secondary immune
deficiencies.” See Knorr v. Sec. of Health & Human Servs., No. 15-1169V, 2018 WL 6991548, at *34 n.7 (Fed. Cl.
Spec. Mstr. Dec. 7, 2018) (citing Immunoglobulins (IgG, IgA, and IgM), Serum, Mayo Clinic Med. Laboratories,
https://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/8156 (last accessed June 14,
2018)).

9
come up in Dr. Al-Huniti’s evaluation from March 2014). Id. at 225. 11 Later on that same month,
in mid-May 2014, Ms. Hughes was treated at Ohio Valley Medical Center emergency room for
abdominal pain and vomiting. Ex. 8 at 4. An X-ray revealed large fecal material and Petitioner
was given an enema, relieving the pain. Id. at 7. No explanation was offered for the incident that
would conceivably relate it to Petitioner’s purported HPV-caused symptoms. Id. at 3 –4.
Additionally, on June 25, 2014, Petitioner had an initial evaluation by Dr. Freeda Flynn
in Saint Clairsville, Ohio for reported “HPV Complications.” Ex. 23 at 18. 12 The differential
diagnosis included mycoplasma (acute), HSV-6 and possible HPV reaction, but Dr. Flynn’s
handwritten assessment was solely “headaches, rash, palpitations” with a notation suggestive of
her conclusion that Petitioner should obtain an evaluation from a pediatric cardiologist. Id. at 20.
Id. Ms. Hughes was prescribed Vitamin C, magnesium supplements, and an antibiotic. Id.
Petitioner followed up with Dr. Flynn on August 22, 2014. Id. at 14. Her physical exam revealed
muscle tenderness at what Dr. Flynn deemed “fibromyalgia trigger points”(Id. at 17). And Dr.
Flynn’s assessment was consistent with the past, but also added “reaction to Gardasil [HPV],”
although the records from this visit contain no explanation for the basis for that determination.
Id.
Toward the fall of 2014, Petitioner continued to obtain more treatment from those
providers whose assessments were consistent with the views of her family regarding the role the
HPV vaccine played in her symptoms, with no evidence of further treatment from those
providers who did not so conclude. For example, Dr. DeMio prescribed pain medication in late
September 2014 to Petitioner, although she did not take it due to fears of nausea side effects. Ex.
17 at 9. In a follow-up visit, she described intense pain after attempting to return to school. Id.
at 14. Dr. DeMio opined that it was still possible (despite negative results) that Ms. Hughes had
Lyme disease, and for treatment he prepared a 19-item list, featuring numerous supplements,
antivirals, and antibiotics. Id. at 17.
That same month, Dr. Flynn prepared a “To-Whom-It-May-Concern” letter stating that
Ms. Hughes was being “treated for a mycoplasma infection and Gardesil [sic] Syndrome. It is in
her best interest to remain home bound from August 19-December 19.” Ex. 23 at 27. And in
mid-September 2014, Petitioner went to the Wheeling Hospital emergency room complaining

11This record also references a letter attachment (Ex. 6C at 225), in which it can be presumed that Dr. Narumanchi
expanded on the bases for her conclusions, but the letter itself does not appear to have been filed.
12
It is not self-evident why Dr. Flynn was consulted to assist with Petitioner’s treatment. Somewhat bearing on the
credibility of her medical assessment, however, is the fact that her practice was raided by the U.S. Drug Enforcement
Agency in 2019 for suspicion of Medicare fraud, and Dr. Flynn was charged with eight counts of distribution of
controlled substances, and one count of health care fraud for her alleged participation in the unlawful prescription of
controlled substances outside of the course of professional practice and without a legitimate medical purpose, and
health care fraud for the submission of claims for services which were medically unnecessary and/or performed below
medically-accepted standards. See Press Release, The United States Department of Justice, Second Appalachian
Region Prescription Opioid Strikeforce Takedown Results in Charges Against 13 Individuals, Including 13 Physicians
(Sept. 24, 2019), https://www.justice.gov/opa/pr/second-appalachian-region-prescription-opioid-strikeforce-
takedown-results-charges-against-13.

10
of heart palpitations after dancing at a wedding. Ex. 18 at 4. Although Ms. Hughes and her
mother again identified the HPV vaccine as causal to emergency care treaters, EKG and chest
x-ray were essentially normal, and she was advised to follow up with outpatient treatment. Id.
2015 and Beyond
From early 2015 to the present, the record establishes that Petitioner has obtained
additional treatment from Dr. DeMio. In January 2015, Dr. DeMio prepared a letter similar to
that penned by Dr. Flynn, noting that he was treating Ms. Hughes “for multiple diseases and
disorders,” including Lyme disease and “Autoimmune and Metabolic Disorders,” and that
because her condition could cause “extreme fatigue, pain, and brain fog,” she required a limited
school schedule. Ex. 10A at 44. Yet, extensive lab testing (re)conducted by Dr. DeMio in May
2015 revealed hardly any abnormal results. Id. at 31 –48.
In August 2020, Petitioner filed a two-page medical record excerpt from the Cleveland
Clinic Neurology Department, dated January 13, 2020, purportedly establishing associated
diagnoses of POTS, sleep pattern disturbance, and insomnia of an unspecified type. Ex. 47, filed
on Jan. 13, 2020 (ECF No. 76-1). The record did not indicate that Petitioner had undergone any
kind of specialized tests that would corroborate these diagnoses, however, nor is it corroborated
with any other records, and thus the probative value of this document is greatly limited. Id.

II. Petitioner’s Expert Opinions

A. Dr. Philip DeMio

Dr. DeMio offered a two-page report in support of Petitioner’s claim, based upon his own
direct experience treating her, and it was filed at the outset of the matter. Report, dated July 30,
2016, filed as Ex. 11 (ECF No. 8-1) (“DeMio Rep.”).

Dr. DeMio obtained his Bachelor of Science degree from Creighton University in 1980,
and his M.D. from Case Western Reserve University in 1984. See CV, filed as Ex. 49 (ECF 76-8)
at 1. He thereafter completed a residency in pathology at the University Hospitals of Cleveland,
and Medicine and Emergency Medicine residencies at Mt. Sinai Medical Center. Id. at 2. His
practice primarily consists of the treatment of chronic tick-borne and other infections and Autism
Spectrum Disorder, plus some treatment of chronic pain or diseases. Id. Dr. DeMio’s curriculum
vitae lists several medical faculty positions he has held (although it gives no dates of service),
including positions at the Cleveland Clinic Foundation, Case Western Reserve University School
of Medicine, Mt. Sinai Medical Center, American College of Surgeons, and the American Heart
Association, as well as certifications he holds from the American College of Emergency
Physicians, and in Advanced Pediatric Life Support and Advanced Trauma Life Support for
Physicians. Id. at 2, 3. Dr. DeMio has written articles on arthritis, gout, inflammation,

11
gastrointestinal issues, and nutrition, and has spoken at conferences covering topics such as chronic
spine injuries and Lyme disease. Id. at 3.

Other special masters have noted, however, that Dr. DeMio’s training and credentials do
not cover the medical or scientific subjects upon which he purports to offer specialized expert
opinions. See, e.g., Holt v. Sec'y of Health & Hum. Servs., No. 05-136V, 2015 WL 4381588, at
*16 (Fed. Cl. Spec. Mstr. June 24, 2015) (“[Dr. DeMio] is board certified in emergency medicine.
He has no formal specialized training in ... any of the several areas [pediatrics, immunology,
neurology, or gastroenterology], in which he proffered opinions. His only publications involved
chapters on arthritis, gout, inflammation, and nutrition in an integrative medicine textbook”); mot.
for review den’d, 132 Fed. Cl. 194 (2017). They have also routinely observed a lack of rigor and
specificity in the opinions he offers. Dia v. Sec. of Health & Human Servs., No. 14-954V, 2017
WL 2644695, at *3 –4 (Fed. Cl. Spec. Mstr. May 25, 2017). As a result, special master
determinations to give little weight to opinions provided by Dr. DeMio have been upheld on
appeal. Bailey Jr. v. Sec. of Health & Human Servs., No. 15-1417V, mot. for rev. denied, slip op.
(Fed. Cl. Nov. 10, 2020) (denying compensation for injuries allegedly caused by flu vaccine based
on conclusion that Petitioner suffered from ALS, not vaccine induced GBS); Wyatt v. Sec'y of
Health & Hum. Servs., No. 14-706V, 2018 WL 7017751, at *22 (Fed. Cl. Spec. Mstr. Dec. 17,
2018), mot. for review denied, 144 Fed. Cl. 531 (2019), aff’d, 825 F. App'x 880 (Fed. Cir. 2020)
(denying compensation because Petitioner failed to prove she suffers from a definitive vaccine-
related injury or that any alleged vaccine-related injury lasted longer than the requisite six months).

Dr. DeMio’s report states that Ms. Hughes was in “very good health” prior to her receipt
of vaccines on August 15, 2013, but thereafter experienced a worsening course of symptoms.
DeMio Rep. at 1. He references her January 2014 initial visit with him, at which time he claims to
have observed on exam “emotional lability,” “tender asymmetric lower extremity muscle masses,”
asymmetric deep tendon reflexes, mottled skin and abnormal toenails. Id. In response, Dr. DeMio
conducted testing and “treated [Petitioner] for findings of immunologic and metabolic
dysfunction.” Id. at 2. He opines that Petitioner’s health declined due to receipt of the three
vaccines in August 2013, rendering her “medically disabled” on a permanent basis. Id.

To support this contention, Dr. DeMio’s report lightly sketches a conclusory theory for
how the vaccines sickened Petitioner. The vaccines she received contain “aluminum adjuvants,
immunogenic microbial proteins, and microbial DNA,” all of which function to “elicit intense
long-lasting reactions in the body.” DeMio Rep. at 2. But these vaccine components can produce
“pathologic responses . . . resulting in lesions in vascular structures and to end organs, via cellular
damage in many tissues.” Id.; L. Tomljenovic et al., Postural Orthostatic Tachycardia with
Chronic Fatigue After HPV Vaccination as Part of the “Autoimmune/Auto-inflammatory
Syndrome Induced by Adjuvants”: Case Report and Literature Review, J. of Investigative Med.
High Impact Case Rep. 1 –8 (2014), filed on Jan. 1, 2018 as Ex. 36 (ECF No. 48-2). It was Dr.

12
DeMio’s view that such harm likely occurred here—especially given the “ruling out” of other
causes as reflected by Petitioner’s test results. Id.

Dr. DeMio specifically argued that the HPV vaccine likely played a role in Petitioner’s
injury. He maintained that (a) this vaccine was not adequately tested before being deemed safe for
administration nationally, and (b) that it has been associated with death in pediatric cases like that
of Petitioner. Finally, he disputed that somatization disorder explained Ms. Hughes’s symptoms,
proposing that certain of her symptoms, like muscle atrophy, or lab findings could not be explained
in this manner. DeMio Rep. at 2.

B. Dr. James Lyons-Weiler, Ph.D.

Dr. Lyons-Weiler’s expert report was the second filed on Petitioner’s behalf. Report, dated
December 12, 2016, filed as Ex. 20 (ECF No. 15-3) (“Lyons-Weiler Rep.”). This report
specifically focused on purported safety issues with the HPV vaccine, with some passing
references to how it might have harmed Ms. Hughes.

As reflected in his CV, Dr. Lyons-Weiler received his B.A. from the State University of
New York-Oswego, followed by a Master’s degree in Zoology from the Ohio State University and
a Ph.D. in ecology, evolution, and conservation biology from the University of Nevada in Reno.
Ex. 21 at 1, filed December 15, 2016 (ECF No. 15-4) (“Lyons-Weiler CV”). Dr. Lyons-Weiler
reports that he is the CEO and Director of “The Institute for Pure and Applied Knowledge,” which
(as its website indicates), is a not-for-profit organization that “help[s] investigators in their efforts
to reduce human pain & suffering through biomedical and related forms of research.” IPAK,
http://ipaknowledge.org/ (last visited October 21, 2020). The website describes Dr. Lyons-
Weiler’s primary interests “in the development of prediction models of adverse outcomes of
biomedical treatments, therapies, and biologic prophylatics [sic]…” Id. It also provides HPV
vaccine information for parents and patients. IPAK, http://ipaknowledge.org/HPV-Vaccine---
Information-for-Parents-and-Patients.php (last visited October 21, 2020).

Thus, as the aforementioned should make clear, Dr. Lyons-Weiler appears to have a
personal interest in vaccine composition, safety, or the molecular processes by which the immune
system reacts to vaccination (and the possible deleterious effects of the same). However, his
training and background render him ill-equipped to offer the opinion he has fashioned for this
matter, as it goes into issues relating to molecular biology and immunology in which he has no
demonstrated expertise. 13 See Bailey Jr. v. Sec. of Health & Human Servs., No. 15-1417V, slip op.

13
Dr. Lyons-Weiler has also participated in numerous public interviews, available on the internet, sharing his opinions
on COVID-19 and the current pandemic, and in so doing has expressed views that could be charitably deemed
interesting. For example, Dr. Lyons-Weiler “explained how the coronavirus’s genetic sequence—which has been
publicly released by China—contains a unique ‘middle fragment’ encoding a SARS (sever acute respiratory
syndrome) spike protein that appears, according to his genome analysis, to have been inserted into the 2019-nCoV

13
(Fed. Cl. Nov. 10, 2020) (sustaining decision of special master denying compensation and noting
that Petitioner’s expert, Dr. Lyons-Weiler, is “not a medical doctor”).

Dr. Lyons-Weiler began by noting the general proposition that “vaccines can trigger
autoimmune disorders,” citing some items of literature in support. 14 Lyons-Weiler Rep. at 1. He
then moved onto a discussion of the propensity of the HPV vaccine to injure. He allowed that
certain epidemiologic studies had concluded an absence of “autoimmune safety concerns”
regarding the vaccine, but maintained that “serious issues” with such studies existed. Id. at 1, 8,
15. He also devoted large portions of his opinion to attempting to lay out safety concerns based on
purported evidence about the dangers of the HPV vaccine generally (and its manufacture more
specifically) that in his view had never been adequately considered. Lyons-Weiler Rep. at 15 –16.15
Dr. Lyons-Weiler maintained that an ample set of individual case studies, or written reports
compiling several case studies, showed in fact that there was a link between the HPV vaccine and
“adverse neurological and immune reactions.” Lyons-Weiler Rep. at 1. None, however, provide
factual similarity to the facts at hand.

For example, Dr. Lyons-Weiler cited one study discussing three case reports involving
rheumatic injuries like lupus or arthritis—injuries not in contention in this case. Lyons-Weiler Rep.
at 2, J.M. Anaya et al., Autoimmune/Auto-Inflammatory Syndrome Induced by Adjuvants (ASIA)
After Quadrivalent Human Papillomavirus Vaccination in Columbians: A Call for Personalized
Medicine, 33(4) Clin. Exp. Rheumatol. 545 –48 (2015), filed on Nov. 30, 2020 as Ex. 54 (ECF No.
90-2). Another referenced article considered 18 young women who were evaluated for
“neuropathy with autonomic dysfunction,” manifesting between one and 20 days post-receipt of
the HPV vaccine. B. Palmieri et al., Severe Somatoform and Dysautonomic Syndromes after HPV
Vaccination: Case Series and Review of Literature, Immunol. Res. (2016), filed on Nov. 30, 2020
as Ex. 82 (ECF No. 93-3) (“Palmieri”). Notably, however, Palmieri’s authors speculated that the
case study subjects had experienced a form of immune dysfunction injury termed

virus using ‘pShuttle’ technology. This technique can only be done in a lab, as it has never occurred naturally in
nature.” Press Release, APR Newswire, Did the Internet News Program “The HighWire With Del Bigtree” Break the
Coronavirus Code? (Feb. 4, 2020) available at https://apnews.com/press-release/pr-
prnewswire/ff548c99a03afb0d69bb7871f7cd4fc0 (last visited Nov. 19, 2020). He also has previously offered support
for the popular misconception that vaccines can cause autism. See e.g., James Lyons-Weiler, Human Studies that
Indicate Autism/Vaccine Link, https://jameslyonsweiler.com/human-studies-that-indicate-autismvaccine-link/ (last
visited Dec. 8, 2020).

14
This is not a controversial overall point in the context of the Vaccine Program, where petitioners routinely succeed
in establishing that a vaccine likely could, and did, cause a particular disease process known to be autoimmune in
pathogenesis. For that reason, I do not include any discussion of the authorities offered to support this particular
contention.
15Because the success of a Program case turns not at all on evaluation of error in vaccine manufacture or governmental
approval, but instead on an intentional “no-fault” analytic inquiry specific to the claimant at issue, there is no need for
lengthy consideration of such arguments. See generally Holmes v. Merck & Co., 697 F.3d. 1080 (9 th Cir. 2012).

14
“autoimmune/inflammatory syndrome induced by adjuvants, or “ASIA”—a causation theory that
has been soundly, and routinely, rejected in Program cases as medically/scientifically unreliable,
thus calling into question the reliability of Palmieri’s conclusions more broadly.16

Other literature cited by Dr. Lyons-Weiler purportedly linking the HPV vaccine to injury
was of similar questionable evidentiary value, especially in light of prior decisions discussing the
very same items. Thus, Dr. Lyons-Weiler referenced another article involving a case study set of
53 female patients who received the HPV vaccine and then reported autonomic dysfunction
thereafter, manifesting as orthostatic intolerance, fatigue, POTS, etc. Lyons-Weiler Rep. at 2; L.
Brinth et al., Suspected Side Effects to the Quadrivalent Human Papilloma Vaccine, 62(4) Dan.
Med. J. A5064 filed on Nov. 30, 2020 as Ex. 61 (ECF No. 91-2) (“Brinth”). But (as I specifically
have noted in other decisions also involving the purported harmful effects of the HPV vaccine),
Brinth’s reliability is greatly diminished by the self-selectivity of its subjects, all of whom sought
out treatment based on the apprehension that their symptoms were vaccine-caused, but were never
compared in a case-control manner (whether to individuals who did not receive the vaccine or
persons who received it but did not report symptoms). Brinth at 1, 4; Johnson v. Sec’y of Health
& Hum. Servs., No. 14-254V, 2018 WL 2051760, at *24 (Fed. Cl. Spec. Mstr. Mar. 23, 2018)
(discussing Brinth’s deficiencies). And Brinth’s authors admitted they could not confirm the causal
link the article explored. Brinth at 4.

Dr. Lyons-Weiler went on to propose a biologic mechanism for how any vaccine could
“lead to permanent injury.” Lyons-Weiler Rep. at 3. He began by describing the autoimmune
process driven by molecular mimicry, or antigenic similarity, between foreign molecules and self-
structures—which can in some instances result in a process whereby antibodies produced to fight
the foreign invader turn on the antigenically-similar self structure. Lyons-Weiler Rep. at 3 –4. An
aberrant immune process proceeding in this manner would be heightened by the inclusion of
adjuvants (substances that up a vaccine’s immunogenicity) in the vaccine—but in particular
aluminum, which Dr. Lyons-Weiler proposed could have an unpredictable impact, especially when

16
See, e.g., Faup v. Sec. of Health & Human Servs., No. 12-87, WL 9313600 (Fed. Cl. Spec. Mstr. June 17, 2019)
(denying entitlement and finding that Petitioner’s experts failed to address established flaws in the ASIA theory),
motion for rev. denied, 147 Fed. Cl. 445, 462–63 (Fed. Cl. 2019); Garner v. Sec’y of Health & Human Servs., No. 15–
063V, 2017 WL 1713184, at *8 (Fed. Cl. Spec. Mstr. Mar. 24, 2017) (observing that the ASIA theory “is, at a
minimum, incomplete and preliminary—and therefore unreliable from an evidentiary standpoint”); Johnson v. Sec’y
of Health & Human Servs., No. 10–578V, 2016 WL 4917548, at *7–9 (Fed. Cl. Spec. Mstr. Aug. 18, 2016) (rejecting
Petitioner’s expert’s expansive medical theory that “any adjuvant [is] capable of causing any autoimmune disease,”
finding it “overbroad, generalized, and vague, to the point that it could apply to virtually everyone in the world who
received a vaccine containing an adjuvant and then at some time in their lives developed an autoimmune disease”);
D’Angiolini v. Sec’y of Health & Human Servs., 122 Fed. Cl. 86, 102 (2015) (upholding special master’s
“determin[ation] that ASIA does not provide[ ] a biologically plausible theory for recovery”), aff’d, 645 Fed. Appx.
1002 (Fed. Cir. 2016); Rowan v. Sec’y of Health & Human Servs., No. 10–272V, 2014 WL 7465661, at *12 (Fed. Cl.
Spec. Mstr. Dec. 8, 2014) (rejecting the ASIA theory because it “is not a proven theory” and no “persuasive or reliable
evidence” supports it), aff’d WL 3562409 (Fed. Cl. 2015).

15
multiple vaccines were administered at once. Id. at 4, 8. Moreover, the HPV vaccine itself was
understood to be far more immune-stimulative (in terms of producing antibodies) than its wild
virus analog. Id. As a result, “an initial hyper-stimulation of the immune system plus molecular
mimicry led [Ms. Hughes] to develop autoimmunity following HPV vaccination due to the
combined effects of adjuvants in multiple doses of vaccines.” Id. at 4.

The medical record in this case, Dr. Lyons-Weiler maintained, also supported the
conclusion of HPV vaccine causality. He noted that Petitioner had herself attributed her symptoms
to the vaccine, along with “a physician” that he does not identify. Lyons-Weiler Rep. at 6. He
pointed to evidence of a single biomarker of inflammation (the BUN/Creatine ratio)17 from testing
Petitioner received in October 2013, during her hospitalization, as significant—despite the fact
that her treaters at the time, like Dr. Lancaster, did not conclude from the overall clinical evidence
and testing that she was experiencing an inflammatory disorder or inflammation-driven disease
process. Id. at 9; compare Ex. 6A at 36. Dr. Lyons-Weiler also offered the opinion that (despite a
total lack of diagnostic support or corroborative proof from the record) “vaccine-induced
spondylosis” was a possible diagnosis, given the “array of conditions” Petitioner had experienced.
Id. at 6 –7, 9.

Finally, Dr. Lyons-Weiler opined that the timeframe in which Petitioner’s symptoms
manifested was medically acceptable. He specifically maintained that “[l]ong onset of
autoimmunity post-vaccination has also been established in the medical literature.” Lyons-Weiler
Rep. at 4; M. Gatto, Human Papillomavirus Vaccine and Systemic Lupus Erythematosus, 32 Clin.
Rheumatol. 1301 –1307 (2013) (“Gatto”). 18 In Gatto, six individuals who experienced the
progression of non-specific symptoms to “full-blown autoimmunity” were considered. Dr. Lyons-
Weiler allowed that causality could not be assumed from such a limited number of case reports,
but felt that because they involved “laboratory-verified” proof of autoimmunity (in that the
presence of autoantibodies was confirmed), they still had some evidentiary value. Lyons-Weiler
Rep. at 5. Dr. Lyons-Weiler did not otherwise explain in any more specific fashion why

17An elevated BUN to creatinine measurement is evidence of blood volume depletion. McKown v. Sec. of Health &
Human Services, No. 15-1451V, 2019 WL 4072113, at *15 (Fed. Cl. Spec. Mstr. July 15, 2019). The BUN (or “blood
urea nitrogen”) test is a blood test used to measure the amount of urea nitrogen in the blood. See Blood Urea Nitrogen
(BUN) Test, Mayo Clinic, https://www.mayoclinic.org/tests-procedures/blood-ureanitrogen/about/pac-20384821 (last
visited on October 21, 2020). Urea nitrogen is a chemical waste product that is typically removed from the body
through the kidneys. Id. A higher than normal BUN test can suggest that the kidneys or liver may not be working
properly. Id. Creatinine is a chemical waste product produced by muscle metabolism. See Creatine Test, Mayo Clinic,
https://www.mayoclinic.org/tests-procedures/creatinine-test/about/pac-20384646 (last visited on October 21, 2020).
Properly functioning kidneys filter creatine from the blood. Id. A creatine test—which measures the level of creatinine
in the blood —can thus indicate kidney irregularities. Id.

Although Gatto was cited by Dr. Lyons-Weiler in his expert report, the reference was never filed in this case despite
18

an order to do so. See Order, dated Oct. 21, 2020 (ECF. No. 89).

16
Petitioner’s initial symptoms manifestation could have taken up to two months to appear, or how
the process would have become chronic, although he did make conclusory representations that
“available science” suggested her overall autoimmune reactive course would last at least eight
years. Id. at 9.

C. Dr. Michael Miller

Dr. Miller, a pediatric rheumatologist, has prepared three expert reports on Petitioner’s
behalf. Report, dated November 15, 2017, filed as Ex. 27 (ECF No. 41-2) (“First Miller Rep.”);
Report, dated January 12, 2020, filed as Ex. 48 (ECF No. 76-2) (“Second Miller Rep.”); Report,
dated August 21, 2020, filed as Ex. 50 (ECF No. 87-1) (“Third Miller Rep.”). He maintains
Petitioner’s injury is best characterized as CRPS, although she also experienced POTS, and that
both were attributable primarily to the HPV vaccine.

Dr. Miller is a Professor of Pediatrics at Feinberg School of Medicine, Northwestern
University. Ex. 27 at 3. Although he identified himself as board certified in pediatric
rheumatology, he could only describe himself as “board eligible” in allergy and immunology—a
nonspecific designation that could cover virtually any medical professional who has not yet taken
the board exams in that specialty but has familiarity with the topics from his general medical
experience. First Miller Rep. at 3. Dr. Miller nevertheless reports to have treated children with
both autoimmune diseases and CRPS, and has had the occasion to evaluate if such diseases were
related to vaccination. Id.

First Report

Dr. Miller’s first, three-page report was notably perfunctory. 19 Looking at the overall
record, Dr. Miller specifically agreed with the notation from the Nationwide Children’s Hospital
record that Petitioner’s overall symptoms and clinical course were consistent with CRPS—
although that record does not itself contain that diagnosis for Petitioner. First Miller Rep. at 3; Ex.
5. Dr. Miller described CRPS as “neuropathy causing severe pain.” Id. at 2. Dr. Miller’s initial
report made no specific reference to any other records that would substantiate this diagnostic
contention.

In addition, Dr. Miller’s first report opined that the HPV vaccine specifically could cause
CRPS, maintaining that the vaccine had been previously associated with neurologic damage.

19
As the docket to this case reveals, Petitioner’s former counsel represented that he was in the process of obtaining
this first report from Dr. Miller (which was eventually filed in November 2017) for months before its filing – and it
was eventually only filed when former counsel “learned” that he had repeatedly missed deadlines I had set in this
matter. It is therefore unclear why this first report, intended to remedy the deficiencies of the reports previously filed
from Drs. DeMio and Lyons-Weiler, was so conclusory and succinct, given the amount of time Petitioner had for its
preparation.

17
Although the literature Dr. Miller offered admittedly showed an extremely low likelihood of such
injury, he proposed that the rarity of the event did not rebut its possibility. First Miller Rep. at 3;
E. Moreira et al., Safety Profile of the 9-Valent HPB Vaccine: A Combined Analysis of 7 Phase III
Clinical Trials, 138(2) Pediatrics 1 –31 (2016), filed on Jan. 11, 2018 as Ex. 30 (ECF No. 46-3)
(three subjects out of 15,000 “experienced severe neurologic disease”). Case reports also existed
that associated the HPV vaccine to small fiber neuropathies or central nervous system disease.
First Miller Rep. at 3; J. Kafaie et al., Small Fiber Neuropathy Following Vaccination, 18(1) Clin.
Neuromuscular Disease 37 –40 (September 2016), filed on Jan.13, 2020 as Ex. 48AF (ECF No. 76-
3) (“Kafaie”). Dr. Miller otherwise maintained that “rare individuals” were likely to experience an
abnormal reaction to the HPV vaccine due to an aberrant immune response, although (due to the
very rarity of their individualized response) they could not be identified in advance and hence
shielded from receipt of the vaccine. First Miller Rep. at 2.

As a mechanism for how the HPV vaccine might trigger disease akin to CRPS, Dr. Miller
proposed that the vaccine could elicit a B cell response causing the production of autoantibodies
that (in what he described as a case of “mistaken identity”) would attack self structures on the
nerves—in effect, the same theory of molecular mimicry proposed by Dr. Lyons-Weiler. First
Miller Rep. at 2. While this cross-reaction would, in his explanation, initiate at the site of injection,
eventually the relevant autoantibodies would “travel into circulation” and injure nerves as well as
cause secondary scarring harm to tissues, which he deemed fibrosis. Id. The damaged nerve cells
would be impaired in function, resulting in “severe, persistent pain” akin to what Ms. Hughes
alleges to have experienced. Id. But Dr. Miller did not offer anything, whether in the way of
literature or other evidence, either describing CRPS consistent with his testimony, or showing how
it could be deemed the product of a pathologic immune response. He otherwise found significant
that Petitioner’s reported onset and subsequent symptomatic course had a temporal relationship to
the vaccination, deeming that alone “diagnostic for post-vaccine Adverse Event,” although he
made no specific argument about (i) when a person would under his theory be expected to manifest
symptoms, or (ii) what about this case fit that theory. Id. at 1.

Second Report

Dr. Miller’s next report (offered by Petitioner in reaction to Respondent’s initial motion to
dismiss) was even shorter than the first, although it contained a bit more substantiation for his
positions and opinions. Regarding his theory that the HPV vaccine had been associated with
injuries like CRPS, Dr. Miller referenced a Japanese study. Second Miller Rep. at 2, citing 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 –29 (2017), filed on Jan. 13, 2020 as Ex. 48C (ECF No. 76-5) (“Ozawa”). Researchers
in Ozawa observed that affected vaccine recipients reported various symptoms, most of which
were ascribed to orthostatic intolerance, CRPS, and/or cognitive dysfunction. Id. at 9. Ozawa itself,

18
however, notes that CRPS occasionally develops in adolescent girls, and a questionnaire-based
study performed during the same time period reported that a group of symptoms, including CRPS,
which were seen in HPV-vaccinated girls, also occurred in Japanese girls with no history of HPV
vaccination—not to mention the study’s other acknowledged limitations that make it comparable
in unreliability to Brinth (e.g., lack of control group, self-selection of studied subjects, etc.) Id.

Dr. Miller also maintained that the feelings of faintness and hypotension that Petitioner had
displayed were consistent with POTS. Second Miller Rep. at 2. However, the medical record filed
in this case does not confirm that Ms. Hughes ever formally received a true, substantiated POTS
diagnosis apart from an “associated diagnosis” in 2020. Dr. Miller nevertheless deemed POTS
another adverse event (albeit independent from the chronic-pain related problems she reports) that
is associated with the HPV vaccine. Second Miller Rep. at 2; S. Blitshteyn, Postural Tachycardia
Syndrome Following Human Papillomavirus Vaccination, 21 European J. of Neurology 135–139,
filed on Jan. 13, 2020 as Ex. 48D (ECF No. 76-6) (“Blitshteyn”); see also Brinth. Blitshteyn was
a case series following six young women who developed new onset POTS six days to two months
following HPV vaccination, and concluded that the temporal association is significant but deserves
further investigation for assessment of a possible causal relationship. Blitshteyn at 138.

In addition, Dr. Miller spent some time pointing out other aspects of Petitioner’s medical
history that he considered supportive of his theory. He re-emphasized the temporal relationship
between her symptoms and vaccination, emphasizing that pre-vaccination she “did not have the
combination of symptoms of the post-Gardasil Adverse Event.” Second Miller Rep. at 1. He
maintained that her onset of symptoms “a few weeks” after receiving the HPV vaccine was
consistent with case report evidence, again referencing articles previously cited like Kafaie. Id. at
2. And he took direct issue with Respondent’s contentions (raised in seeking dismissal) that
somatization disorder was the most substantiated explanation for Petitioner’s symptoms,
maintaining that she did not meet the clinical criteria for that diagnosis (for example, by displaying
a “persistent high level of anxiety”). Id.

Third Report

The final and most recent report filed by Dr. Miller is the most substantive of the three
(although it displays the same foundational deficiencies characterizing his first two). Half of the
report sought to bulwark Dr. Miller’s prior points regarding his causation theory. See generally
Third Miller Rep. at 5 –6. To that end, Dr. Miller again reiterated his claim that literature
persuasively linked the HPV vaccine to CRPS, citing some additional articles for this contention.
Id. at 5; see, e.g., S. Richards et al., Complex Regional Pain Syndrome Following Immunization,
(0) Arch. Dis. Child. 1 –3 (2012), filed Aug. 21, 2020 as Ex. 50F (ECF No. 87-7) (“Richards”).

19
 But the articles filed with Dr. Miller’s third report do not reliably support his contentions.
Richards, for example, discusses four individual case studies in which an adolescent allegedly
experienced CRPS after receipt of the HPV vaccine. In each case, the patient subject experienced
immediate pain and symptoms onset, followed by demonstrated pain, paresthesia, or weakness
within one to two weeks—fact patterns wholly inapposite to Ms. Hughes’s medical history (and
the prolonged, inconsistent pattern of symptoms it reveals). Richards at 1 –2. Richards’s authors
also seemed to place greater weight on the “painful stimulus” of vaccination itself as instigating
the CRPS, rather than the subsequent antigenic/immune response—consistent with what is known
about CRPS but not consistent with Dr. Miller’s theory—and further noted that its four subjects
were all encouraged to receive vaccines in the future, diminishing any possible conclusion that the
HPV vaccine was deemed especially risky in causing CRPS. Richards at 3. In fact, one of the new
articles filed by Dr. Miller along with his third report expressly discounts any association between
the HPV vaccine and CRPS. See F. Huygen et al., Investigating Reports of Complex Regional Pain
Syndrome: An Analysis of HPV-16/18-Adjuvented Vaccine Post-Licensure Data, 2 EBioMedicine
1114 –21 (2015), filed on Aug. 21, 2020 as Ex. 50B (ECF No. 87-3) at 1119 (“Huygen”)
(“[a]ltogether, based on the outcomes of this valuation, there is not sufficient evidence to suggest
an increased risk of developing CRPS following vaccination with HPV-16/18/-adjuvanted
vaccine”).

Dr. Miller further claimed that scientific literature similarly bulwarked the relationship
between the HPV vaccine and POTS. Third Miller Rep. at 6. But he relied for this contention on a
single questionnaire-based study that focused on a very small number of individuals who reported
onset of a chronic ailment soon after HPV vaccination. See M. Martinez-Lavin et al., HPV
Vaccination Syndrome. A Questionnaire-Based Study, 34 Clin. Rheumatology 1981–83 filed on
Aug. 21, 2020 as Ex. 50H (ECF No. 87-9) (“Martinez-Lavin”). He also referenced articles
previously (but unpersuasively) offered by Dr. Lyons-Weiler, like Brinth. Nothing cited by Dr.
Miller was appreciably different —or more persuasive—than literature I have encountered in many
prior cases alleging that the HPV vaccine can cause POTS. And he attempted a slight clarification
of his causation theory, explaining that the initial inflammatory response instigated by vaccination
generally would be sufficient to cause the nervous system to misfire in transmitting signals, later
“making permanent the experience of pain” that characterizes CRPS. Third Miller Rep. at 6. But
he cited no literature at all (beyond what is partially referenced above) substantiating the
association between vaccination and this process—and there is little to no testing evidence from
the period close in time to Petitioners’ vaccination that would suggest the existence of the
complained-of inflammation (as opposed to the nonspecific complaints of leg or other pain).

The second half of the third report provided a more detailed review of Petitioner’s alleged
injuries and how the record connected them to vaccination. First, Dr. Miller set forth a full
explication of the clinical features of CRPS, noting that they can be triggered by independent
autoimmune diseases (a distinguishable contention from the argument that CRPS is itself

20
autoimmune in pathogenesis—something no proof filed by Petitioner substantiates). Third Miller
Rep. at 1 –2; R. Harden et al., Validation of Proposed Diagnostic Criteria (the “Budapest
Criteria”) for Complex Regional Pain Syndrome, 150 Pain 2:268 –74 (Aug. 2010), filed on Aug.
21, 2020 as Ex. 50c (ECF No. 87-4) (the “Budapest Criteria”). He then cited references from the
record that he maintained were consistent with his favored CRPS diagnosis—although close
review of those cites reveals careful selection of one-time instances consistent with individual
criteria, without a treater ever tying them together as Petitioner urges. See, e.g., Third Miller Rep.
at 2 (citing subjective complaints to treaters of severe pain as evidence of hyperalgesia 20 to support
CRPS diagnosis); Third Miller Rep. at 2 (citing Petitioner’s complaints in medical record of pain
due to menstruation to support CRPS diagnosis).

Dr. Miller similarly reviewed the clinical criteria for POTS, noting that Petitioner had
received the diagnosis after proper testing, albeit several years after receipt of the HPV vaccine in
2013. Third Miller Rep. at 3; Ex. 47 at 1. He added that POTS has been suggested to be
autoimmune, noting its association with certain specific autoantibodies. Third Miller Rep. at 2–3.
But to support his contentions, Dr. Miller again cited Blitshteyn, in which only six case studies of
post-HPV vaccine POTS were discussed, with three of the six having been diagnosed with small
fiber neuropathy. Blitshteyn at 136. Although Blitshteyn does favor classification of POTS as
autoimmune, it does not state that small fiber neuropathy is linked to POTS. Id. at 138.

In addition, Blitshteyn’s case studies involved symptoms onset occurring no later than two
months post-vaccination, and the article’s author hedged in suggesting the reliability of the
conclusion that the HPV vaccine was causal. Blitshteyn at 138 (temporal association between HPV
vaccine and POTS “deserves further investigation for assessment of a possible causal relationship”
(emphasis added)). Id. The proposition made by Dr. Miller is not new in the Program. In fact, I
have heard numerous cases, all equally unpersuasive, in which Petitioner’s experts attempt to
connect the HPV vaccine specifically to POTS. 21 Dr. Miller did not also explain how a diagnosis
obtained almost three years after vaccination could be credibly linked to that event, although it
seems his argument mostly assumes that Petitioner’s general course is all connected, and led to the
late-arriving diagnosis.

Dr. Miller took pains as well to attempt to rebut contrary record proof that undermines
Petitioner’s theory and related factual contentions. Regarding treater speculation that Ms. Hughes
suffered from somatization disorder, Dr. Miller reviewed more specifically the criteria for the
diagnosis but deemed it inappropriate under the facts of the case, relying on the same contentions
from his earlier report. Third Miller Rep. at 4. He also directly disagreed with the fact (as amply

20Hyperalgesia is abnormally increased nociception (pain sense); called also hyperalgia. Hyperalgesia, Dorland’s
Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=23666&searchterm=hyperalgesia (last visited Dec. 8, 2020).
21
See e.g., Johnson, 2018 WL 2051760 at *8; McKown, 2019 WL 4072113 at *21.

21
illustrated by the record) that almost all of Petitioner’s treaters, from August 2013 until she saw
Dr. DeMio, disputed the purported role of the HPV vaccine in causing her symptoms, questioning
their credentials to reach this conclusion (although his own, only cursory expertise in immunology
renders him vulnerable to the same accusation). Id. at 6 –7.

Finally, Dr. Miller attempted to substantiate his prior assertions about the reasonableness
of the timeframe for Petitioner’s post-vaccination onset. He claimed at least one item of literature
suggested onset of “HPV syndrome”-like symptoms could begin within 24 hours of vaccination,
although more commonly it would start two to three weeks post-vaccination (despite the fact that
the record does not particularly document Petitioner’s pain as beginning in that period). Third
Miller Rep. at 6; Martinez-Lavin at 1.

Not much weight can be given to this type of questionnaire-based study, however.
Martinez-Lavin’s authors attempted to gather data by e-mailing three questionnaires to individuals
who had reported the onset of chronic disease soon after HPV vaccination. Martinez-Lavin at
1982. But the target population was identified with the help of HPV vaccine web-blog managers,
and by seeking out patients who had previously contacted the researchers after the publication of
an article discussing the topic, rendering the article subject to the defect of selection bias. Id.
(“[i]ndividuals were asked to fill-out the questionnaire only if they had reasons to believe that the
HPV vaccination was related to the onset of their chronic illnesses” (emphasis added)). Moreover,
the concept of “HPV syndrome” itself is amorphous. When discussing limitations of the study,
Martinez-Lavin’s authors explained that HPV vaccination syndrome bears resemblance to various
ailments including but not limited to headaches, fatigue, fibromyalgia, myalgic
encephalomyelitis/fatigue syndrome, and ASIA syndrome—making it virtually indistinguishable
from any grouping of these symptoms. Id. at 1983. And Martinez-Lavin’s authors acknowledged
the lack of direct medical examination of its sample as a clear limitation. Id.

Blitshteyn, Dr. Miller maintained, also allowed for a medically-acceptable onset between
six days and two months post-vaccination—a timeframe more consistent with the record proof of
Petitioner’s first symptoms in October 2013. However, those initial symptoms Ms. Hughes
reported are not particularly consistent with POTS. 22 (For example, Ms. Hughes initially reported
bilateral leg pain accompanied by tenderness to touch (Ex. 24 at 3). Later however, she reported
vague symptoms that happen to overlap with those associated with POTS, such as gastrointestinal
symptoms or lightheadedness.) In addition, Blitshteyn’s case studies have otherwise been
repeatedly criticized in the Vaccine Program as not especially probative. See, e.g., Balasco v. Sec.
of Health & Human Servs., 17-215V, 2020 WL 1240917, at *30 (Fed. Cl. Spec. Mstr. Feb. 14,
2020) (noting that Blitshteyn’s case studies appear to group together reports of adverse events,

22
As Blitshteyn states, “POTS is a heterogeneous disorder of the autonomic nervous system characterized by
orthostatic tachycardia, other symptoms of orthostatic intolerance, and non-orthostatic symptoms such as fatigue,
gastrointestinal disturbance and migraine headache. POTS primarily affects women of reproductive age with a female-
to-male ratio of 5:1 and can commonly be triggered by a virus, surgery, pregnancy or trauma.” Blitshteyn at 4.

22
many of which are non-specific symptoms, in a conclusory manner); Johnson, 2018 WL 2051760,
at *24. Otherwise, Dr. Miller did not propose to explain how this onset would evolve into a chronic
disease process.

III. Procedural History

The matter was initiated in August 2016. Prior to the filing of the Rule 4(c) Report,
Petitioner had already filed the expert reports from Drs. DeMio and Lyons-Weiler. After some
delay occasioned by the parties’ efforts to locate records relevant to the claim, Respondent filed
his Rule 4(c) Report in May 2017 contesting entitlement. ECF No. 31. I reviewed the Report, and
based on its contents informed Petitioner that she would need to obtain a third expert, since I had
serious misgivings about the credibility and persuasiveness of the reports offered from Drs. DeMio
and Lyons-Weiler, in light of my prior Program experience as well as review of the actual reports.
Docket Entry, dated July 7, 2017. To that end, I ordered Petitioner to file such a report by early
September 2017. Docket Entry, dated July 31, 2017.

In the fall of 2017, I dismissed the matter after a series of orders I had issued directing the
Petitioner to file a supplemental expert report were ignored. Decision, dated Sept. 29, 2017 (ECF
No. 38). I also denied Petitioner’s request for relief from the dismissal judgment that subsequently
entered in the case. Order, dated Feb. 16, 2018 (ECF No. 58) (“Order”). But Ms. Hughes was
successful in reviving the case after her appeal of dismissal to the Federal Circuit was granted.
Moczek v. Sec'y of Health & Human Servs., 776 F. App’x 671 (Fed. Cir. 2019). I therefore held a
status conference with the parties in the summer of 2019, ordering Respondent to file expert reports
by the end of October 2019 in reaction to those already filed by Petitioner. Docket Entry, dated
Aug. 8, 2019.

Instead of doing so, Respondent filed a motion requesting an order to show cause why the
case should not (again) be dismissed. Dismissal Motion, dated Oct. 21, 2019 (ECF No. 71). In this
motion, Respondent (observing prior comments in my Dismissal Decision about the weaknesses
of the claim) argued that the existing expert showing by Petitioner was simply deficient, and did
not rise to the level of a prima facie showing for a non-Table, causation-in-fact claim. Dismissal
Motion at 6–7, citing Decision at 11–12. In particular, Respondent highlighted my observations in
the Decision that (a) the record largely did not appear to support Petitioner’s claim, (b) the opinions
offered by her initial two experts were unreliable or weak for other reasons, and (c) the newest
report from Dr. Miller did not remedy any of the above. Dismissal Motion at 2–4.

After some additional delay, Petitioner responded to the motion. Response, dated Jan. 13,
2020 (ECF No. 75). She questioned the procedural appropriateness of Respondent’s motion,
suggesting it constituted a motion for summary judgment that avoided calling itself that. Response
at 3. She also argued that the evidence offered in the case to date was sufficient to meet the burden

23
of proof set forth in the seminal Federal Circuit case Althen v. Sec’y of Health & Human Servs.,
418 F.3d 1247 (Fed. Cir. 2005). Id. at 6–12.

I considered all these filings, and thereafter denied Respondent’s motion. Order, dated
February 19, 2020 (ECF No. 77). In so doing, I noted that (from a summary judgment perspective)
Petitioner’s showing was barely adequate enough to survive Respondent’s motion. Order at 2–3. I
also took into account the Federal Circuit’s observation that Petitioner had at least succeeded in
making out a reasonable basis-level case for her claim, since the objective medical records detailed
her persistent efforts to obtain treatment for the symptoms she complained of, as well as the fact
of vaccination. Moczek, 776 F. App’x at 675–76. However, I added that Respondent could recast
his request to dismiss as one seeking a ruling on the record, and therein attempt to show in more
detailed fashion (whether or not he chose to offer his own experts) that the record and expert
reports filed in the matter simply did not meet Petitioner’s preponderant burden of proof. Order at
3. And I reminded both parties (in keeping with the performance of my inquisitorial role as special
master) that I did not expect Petitioner would ultimately succeed in establishing entitlement, for
the reasons I had voiced many times prior. Order at 3–4.

Respondent took me up on my offer and moved formally for a ruling on the record in May
of this year. See generally Mot. Petitioner opposed the motion in August, offering another
supplemental report (discussed above) from Dr. Miller to support her claim. See generally Opp.
Respondent did not file a reply, and the matter is now fully ripe for resolution.

IV. Parties’ Respective Arguments

Respondent argues that Petitioner has failed to preponderantly establish that her August
15, 2013 vaccination caused the collection of symptoms she experienced thereafter. Mot. at 8.
Respondent supports this contention with evidence arising from Petitioner’s pre-vaccination
records in which she complained of symptoms substantially similar to those she alleges were later
caused by the HPV vaccine. Id. at 9.

Petitioner opposes dismissal, maintains that she has provided evidence establishing a prima
facie case, through medical records, affidavits, and expert reports supporting her claim, and that
Respondent has provided no evidence refuting or disputing the evidence set forth. Opp. at 9.
Petitioner argues that she has met her burden and, as a result, the burden has shifted to Respondent
to show there is an alternate causation. Id. Petitioner asserts that, at a minimum, Respondent should
be ordered to obtain and file a rebuttal report from a qualified expert. Id. at 10.

24
V. Applicable Law

A. Petitioner’s Overall Burden in Vaccine Program Cases

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

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

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, 418 F.3d at 1278: “(1) a medical theory causally connecting the vaccination and
the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason
for the injury; and (3) a showing of proximate temporal relationship between vaccination and
injury.”

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”

25
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must
only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Andreu, 569 F.3d 1367, 1380. Accordingly, special masters must take care not to
increase the burden placed on petitioners in offering a scientific theory linking vaccine to injury.

The Federal Circuit has consistently rejected the contention that the first Althen prong can
be satisfied merely by establishing a proposed causal theory’s scientific or medical plausibility.
See Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also
LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in
the past we have made clear that simply identifying a ‘plausible’ theory of causation is insufficient
for a petitioner to meet her burden of proof.” (citing Moberly, 592 F.3d at 1322)). Rather, this
prong (like the other two) requires a preponderant showing. This naturally flows from the
overarching fact that Program petitioners always have the ultimate burden of establishing their
claim with preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356
(Fed. Cir. 2013) (citations omitted); Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017) (noting
that Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under the
Vaccine Act” by a preponderance standard).

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

Medical records and statements of a treating physician, however, do not per se bind the
special master to adopt the conclusions of such an individual, even if they must be considered and

26
carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,
test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y
of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates
that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and
cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the
opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their
suppositions or bases. The views of treating physicians should be weighed against other, contrary
evidence also present in the record—including conflicting opinions among such individuals.
Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious
for special master to weigh competing treating physicians’ conclusions against each other), aff’d,
698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,
2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review denied, 100 Fed.
Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must align with the theory of how the relevant vaccine can
cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum.
Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,
2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. denied (Fed. Cl. Dec. 3,
2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Legal Standards Governing Factual Determinations

The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,
condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the

27
events in question that was given at a later date, provided that such determination is evidenced by
a rational determination).

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

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

There are, however, 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 & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“’[w]ritten
records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent’”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness’s credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).

28
 When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,
No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional’s failure to document everything
reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;
or (4) a person’s purposeful recounting of symptoms that did not exist. Lalonde v. Sec’y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, there must be evidence that this decision was the result of a rational
determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

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

The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora (such as the district courts). Daubert factors are usually
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health
& Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not

29
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.

A special master’s decision may be “based on the credibility of the experts and the relative
persuasiveness of their competing theories.” Broekelschen v. Sec’y of Health & Hum. Servs., 618
F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). However, nothing requires the
acceptance of an expert’s conclusion “connected to existing data only by the ipse dixit of the
expert,” especially if “there is simply too great an analytical gap between the data and the opinion
proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997));
see also Isaac v. Sec’y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed.
Cl. Spec. Mstr. July 30, 2012), mot. for rev. denied, 108 Fed. Cl. 743 (2013), aff’d, 540 F. Appx.
999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of
expert testimony, based on a particular expert’s credibility, is part of the overall reliability analysis
to which special masters must subject expert testimony in Vaccine Program cases. Moberly, 592
F.3d at 1325–26 (“[a]ssessments as to the reliability of expert testimony often turn on credibility
determinations”); see also Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed.
Cir. 2011) (“this court has unambiguously explained that special masters are expected to consider
the credibility of expert witnesses in evaluating petitions for compensation under the Vaccine
Act”).

Expert opinions based on unsupported facts may be given relatively little weight. See
Dobrydnev v. Sec’y of Health & Hum. Servs., 556 F. Appx. 976, 992–93 (Fed. Cir. 2014) (“[a]
doctor’s conclusion is only as good as the facts upon which it is based”) (citing Brooke Group Ltd.
v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993) (“[w]hen an expert assumes
facts that are not supported by a preponderance of the evidence, a finder of fact may properly reject
the expert’s opinion”)). Expert opinions that fail to address or are at odds with contemporaneous
medical records may therefore be less persuasive than those which correspond to such records. See
Gerami v. Sec’y of Health & Hum. Servs., No. 12-442V, 2013 WL 5998109, at *4 (Fed. Cl. Spec.
Mstr. Oct. 11, 2013), aff’d, 127 Fed. Cl. 299 (2014).

D. Consideration of Medical Literature

Petitioner has filed medical and scientific literature in this case, but not every filed item
factors into the outcome of this decision. While I have reviewed all the medical literature submitted
in this case, I discuss only those articles that are most relevant to my determination and/or are
central to Petitioner’s case—just as I have not exhaustively discussed every individual medical
record filed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016)
(“[w]e generally presume that a special master considered the relevant record evidence even
though he does not explicitly reference such evidence in his decision”) (citation omitted); see also
Paterek v. Sec’y of Health & Hum. Servs., 527 F. Appx. 875, 884 (Fed. Cir. 2013) (“[f]inding

30
certain information not relevant does not lead to—and likely undermines—the conclusion that it
was not considered”).

E. Consideration of Comparable Special Master Decisions

In reaching a decision in this case, I have taken into account other decisions issued by
special masters (including my own) involving similar injuries, vaccines, or circumstances. I also
reference some of those cases in this Decision, in an effort to establish common themes, as well as
demonstrate how such prior determinations impact my thinking on the present case.

There is no error in doing so. It is certainly correct that prior decisions from different cases
do not control the outcome herein. 23 Boatmon, 941 F.3d at 1358–59; Hanlon v. Sec’y of Health &
Hum. Servs., 40 Fed. Cl. 625, 630 (1998). Thus, the fact that another special master reasonably
determined elsewhere, on the basis of facts not in evidence in this case, that preponderant evidence
supported the conclusion that vaccine X caused petitioner’s injury Y does not compel me to reach
the same conclusion in this case. Different actions present different background medical histories,
different experts, and different items of medical literature, and therefore can reasonably result in
contrary determinations.

However, it is equally the case that special masters reasonably draw upon their experience
in resolving Vaccine Act claims. Doe v. Sec’y of Health & Hum. Servs., 76 Fed. Cl. 328, 338–39
(2007) (“[o]ne reason that proceedings are more expeditious in the hands of special masters is that
the special masters have the expertise and experience to know the type of information that is most
probative of a claim”) (emphasis added). They would therefore be remiss in ignoring prior cases
presenting similar theories or factual circumstances, along with the reasoning employed in
reaching such decisions. This is especially so given that special masters not only routinely hear
from the same experts in comparable cases but are also repeatedly offered the same items of
medical literature regarding certain common causation theories. It defies reason and logic to
obligate special masters to “reinvent the wheel”, so to speak, in each new case before them, paying
no heed at all to how their colleagues past and present have addressed similar causation theories
or fact patterns. It is for this reason that prior decisions can have high persuasive value—and why
special masters often explain how a new determination relates to such past decisions. 24 Even if the

23By contrast, Federal Circuit rulings concerning legal issues are generally binding on special masters in all cases.
Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see
also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan.
16, 2014). Special masters are also bound within a specific case by determinations made by judges of the Court of
Federal Claims after a motion for review is resolved.

24
Consideration of prior determinations is a two-way street that does not only inure to the benefit of one party. Thus,
I would likely take into account the numerous decisions finding no association between vaccination and autism when
confronted with a new claim asserting autism as an injury and have informed such claimants early in the life of their
case that the claim was not viable for just that reason. But I would also deem a non-Table claim asserting GBS after

31
Federal Circuit does not require special masters to distinguish other relevant cases (Boatmon, 941
F.3d at 1358), it is still wise to do so.

F. Evaluation of Expert Credentials and Professional Competence

It is common in Program cases for special masters to evaluate competing expert opinions
when deciding non-Table claims—and that process can be very difficult when the experts are
equally well-credentialed and qualified to provide the opinion offered. Under such circumstances,
resolution of a claimant’s success in establishing causation turns on the comparative reliability of
the scientific/medical contentions each side makes, rather than a measure of each particular
expert’s baseline qualifications against the other. See, e.g., D'Tiole v. Sec'y of Health & Human
Servs., No. 15-085V, 2016 WL 7664475, at *20 (Fed. Cl. Nov. 28, 2016) (determination that
causation theory was unreliable did not arise from adequacy of Petitioner’s expert, who was
expressly deemed well-qualified to provide the opinion given), mot. for review den’d, 132 Fed. Cl.
421 (2017), aff'd, 726 F. App'x 809 (Fed. Cir. 2018).

In other circumstances, however, weighing the probative value of an expert’s opinion fairly
takes into account that same expert’s qualifications or professional experience. This is most
obviously necessary when an expert offers an opinion that plainly exceeds his training or
individual competence. Domeny v. Sec’y of Health & Human Servs., No. 94-1086V, 1999 WL
199059, at * 15 (Fed. Cl. Spec. Mstr. Mar. 15, 1999) (dentist not qualified to offer diagnostic
opinion on whether petitioner had experienced a neuropathy), mot. for review den’d, slip op., May
25, 1999 (Fed. Cl.), aff’d, 232 F.3d 912 (Fed. Cir. 2000). But it can even be an issue with experts
who possess immense and impressive credentials, and who in prior cases may have offered reliable
opinions. See, e.g., Rolshoven v. Sec'y of Health & Human Servs., No. 14-439V, 2018 WL
1124737, at *21 (Fed. Cl. Spec. Mstr. Jan. 11, 2018) (otherwise-competent expert with significant
Vaccine Program undermined his credibility in part with constant commentary about relevant legal
standards to be applied in case). This problem becomes amplified when an expert testifies often in
Vaccine Act cases, repeating the same “tics” or errors before numerous special masters in case
after case. 25

receipt of the flu vaccine as not requiring extensive proof on Althen prong one “can cause” matters, for the simple
reason that the Program has repeatedly litigated the issue in favor of petitioners.
25
The degree to which “frequent flyer” experts pose such problems in the Vaccine Program is likely not fully
apprehended by the tribunals that sit in appellate review of the decisions issued by special masters. To give but one
possible example, former Special Master Millman noted that one expert who testified before her had been expert of
record in nearly 40 published entitlement decisions over a ten-year period—and that he in fact justified the
contradictions and opinion shifts in the large number of reports he offered in the case then before her on the fact that
he was so busy with other matters. D.G. v. Sec'y of Health & Human Servs., No. 11-577V, 2019 WL 2511769, at
*191, n.171 (Fed. Cl. Spec. Mstr. Cl. May 24, 2019).

32
 Given the foregoing, special masters can properly deem particular opinions subject to
limited weight if the opinion exceeds the expert’s background competency. Wyatt, 825 F. App'x
at 886 (special master properly gave expert opinion from Dr. DeMio lower weight because (a)
opinion was based mostly on second-hand information, and (b) expert lacked credentials to provide
opinion on autoimmune or neurologic issues). In addition—and in keeping with the fact that the
special masters are expressly intended to draw on their expertise in deciding Vaccine Act claims—
special masters may in some circumstances take note of an expert’s conduct in other cases, and
how they have been received. Yalacki v. Sec'y of Health & Human Servs., No. 14-278V, 2019 WL
1061429, at *33 (Fed. Cl. Spec. Mstr. Jan. 31, 2019) (expert offered same unreliable opinion about
the prevalence of autoimmune reactions to vaccination that had been rejected in prior cases), mot.
for review den’d, 146 Fed. Cl. 80 (2019).

This case presents just such circumstances—and it is why I have cited other cases in which
certain experts offering opinions in this matter have been questioned in the past. I do so not to
embarrass the expert, or provide a basis for ignoring the opinion—rather, my analysis herein
should underscore that the opinions of the relevant experts were not ignored. Indeed, it is to
illuminate better why the opinion might be properly amounted little probative value. Doing so is
hardly arbitrary or capricious—it is in fact the polar opposite of “arbitrary” to point out that an
expert in a case before me has repeatedly been chastised by my colleagues, past and present, for
exceeding his expertise, or repeatedly offering an opinion lacking in scientific rigor or foundation.

G. Determining Entitlement Via Ruling on the Record

I am resolving this claim on the papers, rather than by holding a hearing. The Vaccine Act
and Rules not only contemplate but encourage special masters to decide petitions on the papers
where (in the exercise of their discretion) they conclude that doing so will properly and fairly
resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu
of hearing has been affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d
1362, 1366 (Fed. Cir. 2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V,
2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where
special masters decided case on the papers in lieu of hearing and that decision was upheld). I am
simply not required to hold a hearing in every matter, no matter the preferences of the parties.
Hovey v. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special
master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy
v. Sec’y of Health & Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr.
19, 1991).

33
 ANALYSIS

I. Overview of HPV Vaccine Cases and Primary-alleged Injuries

I have several times evaluated claims relying in whole or substantial part on the contention
that the HPV vaccine can cause injuries akin to what is alleged herein—but never have I ruled for
a petitioner under such circumstances. See, e.g., Sullivan v. Sec'y of Health & Hum. Servs., No.
17-480V, slip op. (Fed. Cl. Spec. Mstr. Nov. 13, 2020) (HPV vaccine not causal of POTS,
narcolepsy, chronic fatigue, small fiber neuropathy, or exacerbation of type 1 diabetes), appeal
docketed, Dec. 14, 2020 (Fed. Cl.); McKown v. Sec'y of Health & Hum. Servs., No. 15-1451V,
2019 WL 4072113 (Fed. Cl. Spec. Mstr. July 15, 2019) (HPV vaccine did not cause POTS or
chronic eczema); Johnson, 2018 WL 2051760 (HPV vaccine not found causal of leg and joint
pain, fatigue, or POTS); Combs v. Sec'y of Health & Hum. Servs., No. 14-878V, 2018 WL 1581672
(Fed. Cl. Spec. Mstr. Feb. 15, 2018) (HPV vaccine not causal of vasovagal syncope).

These prior decisions contain expansive reviews of the expert opinions plus medical and
scientific evidence (to the extent it exists) offered to support a connection between the HPV
vaccine and these related injuries, and I will therefore not recount in great detail the basis for these
holdings. As already noted, they do not mandate the outcome in this case. I merely reference them
to emphasize my great familiarity with the arguments about the HPV vaccine commonly made—
along with the fact that these arguments (at least as of today’s date) have often lacked credible,
reliable scientific/medical support. I also note that as I became more familiar with the nature of
these kinds of HPV-focused claims, I saw less need for holding a hearing. Compare Sullivan
(decided in 2020 without hearing) with McKown and Johnson (decided after hearing in 2018–
19). 26 And these prior cases involve the same literature, and even the same experts. In McKown,
for example, the petitioner also offered treater support from Dr. DeMio, who proposed the
petitioner suffered from “Gardesil [sic] Syndrome,” although I rejected the contention. McKown,
2019 WL 4072113 at *7.

Because CRPS is the primary injury embraced by Dr. Miller (Petitioner’s most credible
expert), some brief discussion of its features is warranted. CRPS has been defined as a “chronic
and incurable condition” impacting the central nervous system. Dixon-Jones v. Sec’y of Health &
Human Servs., No. 14-934V, 2019 WL 7556374, at *16, 31 (Fed. Cl. Spec. Mstr. Sept. 4, 2019)
(petitioner failed to show that flu vaccine caused Petitioner’s CRPS); Dorland’s Medical

26
I also held a hearing in 2019 in a case alleging the HPV vaccine caused POTS and other nonspecific complaints
(like weakness) akin to what is asserted herein, but by Petitioner’s motion the case was dismissed before I had issued
an entitlement determination. Otto v. Sec. of Health & Human Servs., No. 16-1144V, 2020 WL 4719285 (Fed. Cl.
Spec. Mstr. June 17, 2020). I noted in my dismissal decision, however, that after hearing the evidence and live expert
testimony, I would not have ruled for Petitioner in the end, even if he had not asked for dismissal. Id. at 2.

34
Dictionary Online, available at https://www.dorlandsonline.com/dorland/definition?id=110437
(last visited November 17, 2020). Type 1 (called also reflex sympathetic dystrophy) often follows
tissue injury, but without demonstrable nerve injury. Id. CRPS typically involves ongoing pain
“disproportionate to any inciting event,” focusing on an arm or leg and developing fairly rapidly
after injury, a surgery, a stroke or a heart attack. Dixon-Jones, 2019 WL 7556374, at *16, 26 (a
needle prick could cause CRPS); see also Budapest Criteria at 18. The Budapest Criteria relied
upon by Dr. Miller to illustrate the basis for his proposed diagnosis or CRPS have been recognized
as providing a reasonable yardstick for the condition—although diagnosing CRPS is ultimately
(given the current state of medical science) dependent wholly on clinical evidence, since there is
no lab testing that can substantiate it. Dixon-Jones, 2019 WL 7556374, at *16; see generally
Budapest Criteria at 1.

The contention that CRPS can be vaccine-caused has been considered in prior Program
cases, and has resulted in some entitlement rulings favorable to petitioners (including cases I have
adjudicated), although without much in the way of analysis that could be taken into account in
resolving the present case. See, e.g., Garcia v. Sec'y of Health & Human Servs., No. 18-1688V,
2020 WL 6285315 (Fed. Cl. Spec. Mstr. Sept. 24, 2020) (Respondent conceding in case before me
that evidence supported claim that flu vaccine caused CRPS); Brown v. Sec'y of Health & Human
Servs., No. 13-594V, 2014 WL 831967 (Fed. Cl. Spec. Mstr. Feb. 5, 2014) (same). In such cases,
however, the Petitioner has generally demonstrated that vaccine administration itself precipitated
trauma close-in-time to vaccination that later resulted in CRPS—not (as alleged here) that the
vaccine precipitated over time a series of progressive, nonspecific symptoms. See, e.g., Garcia,
No. 18-1688, Petition, dated November 1, 2018 (ECF. No. 1) at 1 (onset within three hours of
vaccination). In fact, in cases like Garcia the petitioner initially sought to demonstrate that he had
experienced a shoulder injury related to vaccine administration, or “SIRVA”—a common Table
claim in the Program involving rapid (within two days) onset of post-vaccination pain, and thus
circumstances distinguishable from what the medical record shows Ms. Hughes experienced. Id.
at 5.

By contrast, special masters who have engaged in a more detailed consideration of the
science purportedly linking different vaccines to CRPS have determined that the causation theories
were largely wanting. In Dixon-Jones, for example, Special Master Oler’s decision to dismiss the
claim turned in part 27 on her conclusion that the flu vaccine had not been preponderantly shown
to cause CRPS. Dixon-Jones, 2019 WL 7556374, at *42–43. She noted that although most of what
is known about CRPS associates it with direct or traumatic injury, the petitioner’s theory depended

27The Dixon-Jones decision also arose from Special Master Oler’s finding that the Petitioner’s symptoms could not
preponderantly be shown to constitute CRPS, since (a) the petitioner had not received the diagnosis, (b) petitioner’s
pain was better described as “widespread” or “migratory” rather than “regional,” i.e. focused on one or more limbs
(with the latter consistent with CRPS but not the former), and (c) petitioner’s pain course waxed and waned, and
therefore was not “unrelenting” as would be the case for CRPS. Dixon-Jones, 2019 WL 7556374, at *33–40.

35
on vaccine-instigated inflammation—a mechanism that the literature did not support for the
condition’s pathogenesis. Id. at *42 (“the state of literature at this time does not suggest that the
systemic immune response involved in vaccination can trigger nerve damage or neuronal injury
and the subsequent complex central sensitization process that eventually leads to CRPS”). She
further observed that the claimant’s causation theory heavily relied on the concept of cytokine
activation as driving the inflammatory process—a theory that had been repeatedly rejected in
disparate Vaccine Program cases. Id. at *43 (citations omitted).

II. Petitioner Has Not Carried Her Burden of Proof

A. Petitioner Has Not Demonstrated on the Present Record That She Suffered from
CRPS or POTS 28

As a threshold matter, certain injuries alleged by the Petitioner are not preponderantly
supported by the record. It is well-recognized by Program precedent that determining the existence
of an alleged injury is a preliminary step to conducting the Althen analysis in many cases—for
there can be no vaccine injury claim without proof of an injury. Broekelschen, 618 F.3d at 1346.
Here, neither CRPS nor POTS find corroboration in the record, and thus Petitioner’s claims that
she experienced either must fail at the outset.

First, and most importantly, the record does not support Dr. Miller’s supposition that CRPS
adequately characterizes Petitioner’s overall basket of symptoms. Petitioner’s history is not
preponderantly congruent with CRPS as set forth in the diagnostic criteria filed by Dr. Miller, but
instead reveals (a) some issues close-in-time to vaccination associated with a UTI or menses,
followed by (b) unexplained pain two months later, the etiology of which that clinical exam and
testing (which was comprehensive and included a neurologic evaluation) could not illuminate.
Such a course is inconsistent with CRPS, the hallmark of which is persistent, burning pain greatly
exceeding the injury believed to have precipitated it, and located “regionally” rather than
systematically. Budapest Criteria at 18. And the record thereafter continued to feature an absence
of corroboration of a regional pain syndrome (unless the views of obviously less-qualified medical
treaters like Dr. DeMio are given weight they do not otherwise deserve).

In addition, Ms. Hughes’s pain cannot be characterized at all as “unrelenting.” Budapest
Criteria at 18. On the contrary—Petitioner was even observed in some treater encounters, such as
her November 6, 2014 visit with Dr. Li to seem well during those times when the actual exam was
not being performed. Ex. 3 at 11. And none of Petitioner’s actual treaters (and there were many)

28 Dr. Lyons-Weiler’s contention that Ms. Hughes may actually have suffered from spondylosis is particularly
untenable, and merits no further comment. Besides his total lack of medical qualifications to offer that counter-
diagnosis, it finds absolutely no support in the medical record, and also is not endorsed by Dr. Miller—the expert
retained by Petitioner after I initially warned her counsel about the inadequacy of her existing expert opinions.

36
ever proposed CRPS as a possible diagnosis, despite ample chance to do so, instead offering no
clear etiology. This fact does not “open the door” to Dr. Miller’s diagnosis (given the absence of
another firmly agreed-upon diagnostic etiology)—for it is a petitioner’s burden to prove injury as
alleged, not Respondent’s to prove the negative. K.L. v. Sec. of Health & Human Servs., 134 Fed.
Cl. 579, 606 (Fed. Cl. 2017).

Second, the record in this case is unsupportive of POTS as a credible diagnosis. At bottom,
almost no evidence has been filed to substantiate it. POTS is a form of orthostatic intolerance,
often triggered upon standing up from a seated or reclined position. Cleveland Clinic, POTS:
Causes, Symptoms, Diagnosis & Treatment, available at
https://my.clevelandclinic.org/health/diseases/16560-postural-orthostatic-tachycardia-syndrome-
pots (last visited Aug. 17, 2020) filed on Aug. 21, 2020 as Ex. 50D at 1. It is characterized
specifically by a heart rate increase not also associated with a change in blood pressure, and is best
confirmed by a tilt table test (in which the subject is strapped to a table that is slowly turned from
horizontal to vertical, while heartrate and other readings are taken). Id.; Mayo Clinic, Tilt Table
Test, available at https://www.mayoclinic.org/tests-procedures/tilt-table-test/about/pac-20395124
(last visited November 17, 2020); Yalacki, 2019 WL 1061429, at *40, n.10.

Here, Petitioner displayed none of the most common characteristics of POTS in the months
immediately after vaccination, such as syncope, faintness on standing, or fatigue. The first treater
to even propose it as a possibility worthy of inclusion in the diagnostic differential was Dr. Al-
Huniti in March 2014—but by that time (more than six months post-vaccination) Ms. Hughes had
received comprehensive diagnostic workups, with no other treaters also so suggesting or observing
symptoms that might raise it a viable diagnostic proposal. Petitioner also does not appear ever to
have received a tilt table test that would formally confirm the diagnosis. The incomplete January
2020 record from the Cleveland Clinic merely asserts the diagnosis—it does not substantiate or
corroborate it. Ex. 47. Thus, it is just as likely, without more, that the record is repeating assertions
about medical histories provided to treaters by Petitioner or Ms. Moczek, rather than setting forth
confirmable treater diagnoses. The POTS diagnosis is not preponderantly supported by this record.

B. Petitioner’s Symptoms Have Not Been Shown to be Vaccine-Caused or Related
(Althen Prong Two) 29

The most compelling reason for dismissal of Petitioner’s case also illuminates my rationale
for deciding the case without a hearing. For even if I could find that the HPV vaccine is capable
of causing a series of nonspecific symptoms consistent with those Ms. Hughes experienced, I could

29
I address the Althen prongs herein in order of their importance to my determination, rather than in their sequential
order.

37
not also find on this record that she has preponderantly established that her symptoms were related
to or caused by that vaccine, or any others she received.

The record does not suggest that Ms. Hughes began experiencing any symptoms close-in-
time to vaccination that manifested the start of some immunologic-driven changes that became
chronically pathologic. And no testing results she received—from October 2013, when she first
presented to treaters, until the present—are consistent with her experiencing a vaccine-produced
injury (for example, that which would demonstrate the presence of ongoing inflammation). Her
hospitalization in October 2013 and the work-up she received at this time are particularly
persuasive in suggesting petitioner had not at this time been harmed by vaccination. And although
(as noted by Dr. Miller) CRPS is characterized by continuing pain disproportionate to any inciting
event (Third Miller Rep. at 1), the record in this case reflects that Petitioner’s pain was not constant
and typically waxed and waned, even within the same short temporal period. See, e.g., Ex. 3 at 16
(Dr. Li noted petitioner could remove tight skinny jeans off her legs without having pain) and 2
(Dr. Li noted disparity between the persistent pain reported by Petitioner and her seemingly healthy
demeanor and conduct during exam).

In reaching this conclusion, I acknowledge the existence of record evidence that Petitioner
was complaining of pain and other symptoms within a month of her receipt of the HPV vaccine.
For instance, Ms. Hughes did repeatedly report to treaters persistent lower limb and back pain,
headaches, fatigue, and abdominal pain. She also alleges a more immediate reaction, although such
allegations find no support in the contemporaneous record. See Pope v. Sec. of Health & Human
Servs., No. 14-078V, 2017 WL 2460503 at *19 (Fed. Cl. Spec. Mstr. May 1, 2017) (noting that
Petitioner’s allegations need not be accepted based simply upon uncorroborated allegations,
especially where those after-the-fact allegations are rebutted by contemporaneous proof).30 But
putting aside the subjective nature of these complaints (and specifically the fact that testing never
corroborated an underlying disease process correctly led treaters to propose that Ms. Hughes
suffered from somatization disorder), petitioner has not preponderantly established that this
grouping of overall-nonspecific symptoms was likely caused by the HPV vaccine or any of the
other vaccines she received in August 2013.

Petitioner can also reference little persuasive evidence that any treaters associated her
complained-of symptoms with the HPV vaccine. Any providers who have so opined that actually
saw her, like Drs. DeMio or Flynn, either possess significant credibility issues that make it
impossible to give their views much weight, or have utterly failed to explain the bases for their

30
I do not give significant weight to the witness statements/affidavits provided by Petitioner or Ms. Moczek, as their
contentions about a purported immediate vaccine reaction are not corroborated by record proof. See Burns v. Sec’y of
Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine
whether to afford greater weight to contemporaneous medical records than to other evidence, such as oral testimony
surrounding the events in question that was given at a later date, provided that such determination is evidenced by a
rational determination).

38
diagnostic conclusions. By contrast, a greater number of credible and competent medical providers
of varied specialties (Drs. Li, Lindsay, and Lancaster) seen by Petitioner soon after the
vaccinations at issue consistently rejected Ms. Moczek’s layperson view that the HPV vaccine had
likely propagated Petitioner’s symptoms—and their opinions were based on actual exam and lab
work.

In the face of the above, Petitioner relies on the temporal relationship of the start of her
symptoms to vaccination, reasoning that (because she purports to have been in excellent health
pre-vaccination) her turn of circumstances must be vaccine-caused. This sort of reasoning is
rejected out of hand in the Program, however. Moberly, 592 F.3d at 1323 (“a proximate temporal
association alone does not suffice to show a causal link between the vaccination and the injury”)
(citations omitted). Absent credible and probative evidence that the vaccine “did cause” her
injuries, Petitioner cannot prevail merely by pointing out a change in her purported health
circumstances post-vaccination.

A final, but significant, evidentiary point weighing against Petitioner on her Althen prong
two showing are the numerous instances in the record in which treaters proposed that her
symptoms might reflect somatization disorder, rather than a vaccine-related injury. Somatization
disorder is defined as “[t]he process by which psychological needs are expressed in physical
symptoms.” Doe v. Sec'y of Health & Hum. Servs., 94 Fed. Cl. 597, 606 n.15 (2010), aff'd, 656
F.3d 1343 (Fed. Cir. 2011). In other unsuccessful Program cases, treater views that somatization
disorder might explain a petitioner’s overall presentation are often found in the medical records.
See, e.g., Pless v. Sec. of Health & Human Servs., No. 16-271, 2017 WL 836610 at * (Fed. Cl.
Spec. Mstr. Feb. 6, 2017) (treater documented in record that he was very suspicious of an element
of a somatization disorder); Floyd v. Sec. of Health & Human Servs., No. 10-739, 2014 WL
1392376 at *2 (Fed. Cl. Spec. Mstr. Mar. 20, 2014) (multiple treaters noting in medical record
probable somatization disorder).

Here, treaters who saw Ms. Hughes in the months immediately following her August 2013
vaccinations proposed somatization disorder as a more likely explanation for her symptoms. See,
e.g., Ex. 6C at 30 (Dr. Lindsey indicated in the record “I feel that the underlying etiology of her
symptoms is a somatization disorder and I feel strongly that she would benefit from Cognitive
Behavioral Therapy”). Some treaters reached this conclusion after exams and other clinical tests
failed to identify an alternative etiology, or (in Dr. Li’s case) after personally observing a
divergence between Petitioner’s claimed pain symptoms and her behavior once an in-office exam
had concluded. Ex. 6A at 23 (diagnostic consideration of “[a]nxiety/[m]ood disorder: This is of
high likelihood given the nature of the complaints and the lack of objective findings to substantiate
the complaints”); Ex. 3 at 16 (Dr. Li noting “..she [Petitioner] was wearing tight skinny jeans.
When she was taking them off her legs (it was tight and required some pulling) she could do it
without having pain or showing any grimacing. However, when I do light tough (just my

39
fingertips)… it was extremely painful enough to bring tears...”); Thus, the record establishes the
possibility of somatization disorder as a reliable, evidence-based explanation for Petitioner’s
overall condition that was not proposed in passing.

I readily acknowledge that this record does not contain a fully-substantiated, formal
diagnosis for somatization disorder, even if (contra Dr. Miller’s contentions) there is ample proof
of Petitioner’s anxiety when displayed to treaters or discussed with them. And as special master I
am not called upon (or even qualified) to make such a diagnosis myself. But it remains undisputed
that several qualified medical treaters, approaching the Petitioner from different diagnostic
“angles” and based on their various expertise, proposed this as a possible etiology for her
symptoms. Petitioner has not rebutted their determinations or provided any persuasive reason to
find the possibility unlikely (outside of Dr. Miller’s ipse dixit), further undermining the success of
her Althen prong two showing. K.L., 134 Fed. Cl. 579, 598 (“regardless of whether the burden of
proof ever shifts to the respondent, the special master may consider the evidence presented by the
respondent in determining whether the petitioner has established a prima facie case”) (internal
citations omitted).

C. Petitioner Has Not Demonstrated that the HPV Vaccine Can Cause Injuries
Similar to Those Complained-of in this Case (Althen Prong One)

Besides being unable to show a cognizable, vaccine-caused injury, or that the HPV vaccine
was likely responsible for her basket of symptoms, Petitioner was also unable to preponderantly
demonstrate that the HPV vaccine “can cause” POTS or CRPS.

Contentions regarding POTS being caused by the HPV vaccine are more easily resolved.
As stated above, I have repeatedly ruled against petitioners alleging that the HPV vaccine could
cause POTS. See e.g., McKown, 2019 WL 4072113; Combs, 2018 WL 1581672; see also Otto v.
Sec’y of Health & Hum. Servs., No. 16-1144V, 2020 WL 4719285 (Fed. Cl. Spec. Mstr. June 17,
2020) (case dismissed after hearing on claimant’s request, but noting that petitioner had not
successfully met his burden of proof). As I note above, these cases do not compel the same result
herein, but they involve arguments similar to what has been put forward here, with Petitioner
relying on much of the same reasoning previously rejected but without offering any new bases for
reexamination of prior conclusions.

My prior determinations about the lack of demonstrated, reliable association between
POTS and the HPV vaccine are the product of intensive and careful evaluation, focusing on what
is known about POTS and its relationship to the immune system. POTS is most commonly not
considered attributable to an autoimmune process interfering with the autonomic nervous system
(and thus would not likely be the product of an aberrant immune response triggered by
vaccination). Rather, it is thought to reflect the autonomic system functioning properly in response

40
to stressors (for example, hypovolemia, in which a person’s dehydrated states produces orthostatic
imbalance). See, e.g., McKown, 2019 WL 4072113, at *52. Thus, POTS can occur in the context
of a functioning autonomic nervous system.

Moreover, while it is true that some evidence has emerged in the last ten years that in rare
cases POTS might sometimes be attributable to an autoimmune process involving anti-adrenergic
antibodies (which can cause heart rate increases), this is the exception to the rule—and to date, not
nearly enough is known about how this process works or what would initiate it, to draw
conclusions in Program cases sufficient to meet the preponderance level of evidence.31 Further, in
none of these cases was it preponderantly established, through citation to reliable scientific
evidence or expert testimony, that the HPV vaccine could cause the production of the anti-
adrenergic autoantibodies posited to cause POTS in some limited circumstances. 32

Against this backdrop, nothing offered in this case by Petitioner or her experts provides
more recent or reliable scientific/medical evidence, in whatever form (literature, expert testimony,
etc.) supporting the conclusion that the HPV vaccine might cause POTS. For example, Dr. Lyons-
Weiler could only offer evidence in the form of case study-oriented association, like Brinth, which
is weak and dependent on self-selected patient populations rather than scientifically-reliable
studies. Further, Dr. Lyons-Weiler’s critiques of epidemiologic studies that discount the HPV
vaccine-POTS relationship are equally unpersuasive. Lyons-Weiler Report at 15, referencing C.
Chao et al., Surveillance of Autoimmune Conditions Following Routine Use of Quadrivalent
Human Papillomavirus Vaccine, 271 J. Internal Med. 193–203 (2012) (“Chao”). 33 Chao was a
peer-reviewed observational study analyzing a database comprised of the medical histories of
approximately 189,000 women in California to determine whether the studied population had
developed a variety of autoimmune conditions after receiving the HPV vaccine. Chao at 194. As I
have previously observed, Chao is very strong evidence rebutting the contention that the HPV
vaccine likely elicits any autoimmune diseases. Johnson, 2018 WL 2051760 at *25.

31
Another case I decided (although not involving the HPV vaccine specifically) is instructive on this point. See
Yalacki, 2019 WL 1061429, at *18 (discussing change in medical views on the likelihood that HPV might in some
cases be an autoimmune-driven condition).
32In Yalacki, the petitioner’s experts proposed that an “adrenergic antibody,” presumably produced in response to the
hepatitis B vaccine, was the most likely mechanistic causal element in triggering Petitioner’s POTS. Yalacki, 2019
WL 1061429 at *20. However, the literature offered to support this contention did not involve an actual measurement
of the antibody in question in humans. Id. While the petitioner was able to offer some reliable literature exploring the
possibility that some cases of POTS might be autoimmune-mediated, Petitioner acknowledged that more recent
research moved away from autoimmunity as the most likely explanation for POTS, in the majority of individuals. Id.
at *31.
33
Dr. Lyons-Weiler refers to the Chao study multiple times in his expert report, but this item of literature was never
filed in this case (despite my order that Petitioner do so). See Order, dated Oct. 21, 2020 (ECF No. 89). I have, however,
in other decisions discussed Chao at length, and am thus very familiar with its findings. See e.g., McKown, 2019 WL
4072113, at *36; Johnson, 2018 WL 2051760, at *15, 25; Maciel v. Sec. of Health & Human Servs., No. 15-362V,
2018 WL 6259230, at *14 (Fed. Cl. Spec. Mstr. Oct. 12, 2018).

41
 Petitioner also puts too much emphasis on case reports, or literature that depends on a
curated selection of case reports like Blitshteyn. Although case studies in which a temporal
correlation was observed between receipt of the HPV vaccine and POTS or comparable kinds of
orthostatic intolerance are some evidence that should be considered as part of a special master’s
overall entitlement determination, they are not particularly probative of causation, and for that
reason do not in most instances merit significant weight. See R.V. v. Sec. 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). And as noted above, many of these items
of literature (e.g., Brinth or Ozawa) are facially deficient and unreliable evidence establishing a
link between POTS, or other allegedly-autoimmune conditions, and the HPV vaccine.

Petitioner’s showing associating CRPS with the HPV vaccine was similarly deficient,
although in a somewhat less clear-cut manner. I have not previously addressed in a prior decision
whether the HPV vaccine can cause CRPS, but other persuasively-reasoned decisions directly
considering this issue have not been favorable to petitioners. See Balasco, 2020 WL 1240917, at
*31 (noting that the American Autonomic Society has concluded that the data do not support a
causal relationship between HPV vaccination and CRPS, POTS, or other forms of dysautonomia)
(internal citations omitted). As more specifically noted in Balasco, an association between HPV
vaccination and various symptoms such as CRPS, POTS, or SFN is cast further into doubt by the
fact that, notwithstanding the assumption that all three conditions involve autonomic activity,
“there is little or no substantiation of any shared pathophysiology.” Id. Nothing offered in this case
provides me with a basis for reaching a different outcome herein.

Moreover, decisions I have rendered involving the HPV vaccine and its general association
with similar injuries to that alleged herein are also not supportive of Petitioner’s theory that the
HPV vaccine can initiate (whatever the proposed mechanism) an autoimmune response sufficient
to cause any kind of neuropathic condition. McKown, 2019 WL 4072113, at *48-49 (holding that
even if it was determined that a rare, neuropathic/autoimmune form of POTS could include
symptoms consistent with Petitioner’s skin rashes and syncope, there remained substantial
deficiencies in Petitioner’s theory that HPV vaccine could trigger or exacerbate such additional
symptoms via an autoimmune process); Combs, 2018 WL 1581672, at *19 (petitioner could not
substantiate her theory that she experienced vasovagal/reflex syndrome as a result of HPV
vaccination, with even indirectly-relevant reliable scientific or medical evidence).

Petitioner’s experts in this case were unable to offer new perspectives on the issue of HPV
vaccine causation that would persuasively establish a reason for me to look anew at similar
contentions. Dr. Lyons-Weiler, for example, either repeated general points about causation that
come close to bromides in the Program (such as “molecular mimicry” as the mechanistic heart of

42
any pathologic process allegedly resulting in a vaccine-induced injury), or made contentions about
the HPV vaccine’s potentiality for cross-reaction due to homology (amino acid sequence or
structure similarity) that I have heard, but rejected, many times before. Sullivan v. Sec’y of Health
& Hum. Servs., No. 10-398V, 2015 WL 1404957, at *17–18, n. 30 (Fed. Cl. Spec. Mstr. Feb. 13,
2015) (while the law does not require Petitioner to “prove” homology in a Program case, mere
assertion that HPV strain shares sequences with human body such that molecular mimicry might
occur resulting in injury was by itself insufficient to satisfy burden). He similarly invoked literature
(such as Brinth) to which I have not given significant weight in the past.

Compounding the specific deficiencies listed above, the general credentials and
qualifications of the experts in this case also harmed Petitioner’s Althen prong one showing—
especially those of Drs. DeMio and Lyons-Weiler. Neither have immunologic experience or
trustworthy background in the kinds of injuries complained of herein—and Dr. Lyons-Weiler’s
credentials are not even medically-oriented in the first place. 34 Duncan v. Sec’y of Health &
Human Servs., No. 16-1367V, 2020 WL 6738118 at *2 (Fed. Cl. Spec. Mstr. Oct. 19, 2020) (noting
that Dr. Lyons-Weiler is not a medical doctor but rather has a Ph.D. in ecology).

These two experts also have also been previously been criticized for espousing unreliable
opinions. See, e.g., Sterling v. Sec'y of Health & Hum. Servs., No. 16-551V, 2019 WL 5098964,
at *11 (Fed. Cl. Spec. Mstr. Aug. 27, 2019) (observing the “meandering, confusing nature” of Dr.
Lyons-Weiler’s reports, along with the fact that he had no demonstrated training or expertise in
immunologic matters); Kamppi v. Sec'y of Health & Hum. Servs., No. 15-1013V, 2019 WL
5483161, at *11 (Fed. Cl. Spec. Mstr. July 24, 2019) (giving little weight to Dr. Lyons-Weiler’s
opinion that “did not advance any theory” bearing on how the influenza vaccine could cause GBS
15 weeks later, and that was not otherwise bulwarked by evidence of his “background, his past
research, or his area of expertise”); Wyatt, 2018 WL 7017751, at *22 (noting that Dr. DeMio “has
been criticized by this Court in the past for testifying in cases regarding medical theories which he
is not qualified to render,” and finding that the opinion he offered was conclusory and unreliable).
I have reached the same conclusions. A.S. v. Sec'y of Health & Hum. Servs., No. 16-551V, 2019
WL 5098964, at *7 n4 (Fed. Cl. Spec. Mstr. Aug. 27, 2019) (noting that Dr. Lyons-Weiler cited
literature that did not support his positions, and that he appeared to be wholly unqualified to opine
on the question of vaccine causation); Wolf v. Sec. of Health & Human Services, No. 14-342V,
2016 WL 6518581 at *16 (Fed. Cl. Spec. Mstr. Sept. 15, 2016) (finding Dr. DeMio’s opinion

34
In so maintaining, I certainly do not purport that only medical doctors may credibly testify in the Program. A Ph.D.
without a medical license or degree can certainly persuasively testify on his or her area of expertise if relevant to a
claim (for example, a research immunologist might credibly testify as to vaccine function). And there are physicians
who lack an M.D., such as osteopaths, who nevertheless possess ample, real-world experience in treating medical
conditions that renders them effective and useful experts, especially on diagnostic disputes. But an ecologist like Dr.
Lyons-Weiler, with no demonstrated treatment background or training in immunology, cannot expect to be taken
seriously as a Program expert when offering an opinion on matters of vaccine causation that facially lie well outside
his actual field—and it cannot be deemed arbitrary or capricious for a special master to observe such a credential
deficiency and give it probative weight in analyzing the expert’s opinion.

43
conclusory and unsupported by reliable science and that he lacked sufficient expertise to
persuasively establish how vaccine would affect Petitioner from immunologic standpoint).

Overall, Drs. DeMio and Lyons-Weiler possessed serious credibility deficiencies—as I
informed Petitioner early on in the case’s life, when urging her to obtain a supplemental expert.
Although I have reviewed their opinions and discuss them, and have also attempted to give
consideration to articles or literature referenced in their reports, these two experts overall did not
offer opinions that warranted significant evidentiary weight.

Dr. Miller, by contrast, was more facially-credentialed, and he has offered reports that do
arise from his immediate expertise, and which otherwise merited a more careful evaluation. But
his opinion was ultimately unreliable, and/or inconsistent with the medical record in this case. In
particular, it ignored, or unpersuasively attempted to rebut, record evidence that was contrary to
his favored CRPS diagnosis (which, as noted above, none of Petitioner’s actual treaters ever
embraced). His views as a rheumatologist were also undercut by the determinations of
rheumatologic workups that Petitioner actually received. Ex. 7B at 7 –11; Ex 6A at 36. He offered
literature like Huygen that directly undercut his arguments about CRPS and its association with
the HPV vaccine. Huygen at 1114. And he has no particularized expertise in immunology that
would imbue his contentions about the HPV vaccine with added heft missing from the literature
or other evidence filed in this case. Indeed—Dr. Miller made other contentions about vaccine
causation that he was somewhat unqualified to advance, at least in any persuasive manner. His
report overall embraces a diagnosis that finds little corroboration from the medical record, and his
three reports, while an improvement when compared to those Petitioner offered from her other two
experts, were still not sufficient to meet the preponderant standard of proof in establishing the “can
cause” prong.

D. Petitioner Has Not Demonstrated that the Timeframe for Onset of Her
Symptoms was Medically Acceptable (Althen Prong Three)

The third Althen prong also does not favor Petitioner, although it presents a slightly closer
question. On the one hand, there is no reliable evidence that Petitioner began to experience any
symptoms arguably vaccine-related before October 2013. Those problems she encountered close-
in-time to vaccination were distinguishable (for example, attributable to menses), and affirmations
or sworn statements to the contrary, whether from Petitioner or Ms. Moczek, are not sufficiently
corroborated by record proof to be deemed superior to what the first records from Petitioner’s
hospitalization reveal. Petitioner’s sole credible expert, Dr. Miller, has not offered much beyond
case reports, or scientific articles I have previously deemed weakly probative, like Ozawa, to
support the conclusion that receipt of the HPV vaccine could begin to produce manifest clinical
signs two months after its administration—especially in a record devoid of any inflammatory or
immune-driven process occurring within that two-month timeframe.

44
 Petitioner’s POTS allegations and their timing are also questionable. POTS is not even
proposed by a treater for inclusion in the diagnostic differential until six to seven months post-
vaccination, with little to no evidence prior to that time of an onset (as reflected in the kind of
symptoms typically associated with POTS, like syncope). In addition, Petitioner’s purported POTS
diagnosis 35 was obtained on August 15, 2019—exactly four years after her first and only HPV
vaccination. Although diagnosis is distinguishable from onset, the credibility of the contention that
Petitioner experienced POTS onset in a medically acceptable timeframe after vaccination is greatly
undercut when it has taken years for treaters to even consider the diagnosis as a possibility given
the overall record.

At the same time, however, Petitioner has offered some reliable proof consistent with her
theory that the HPV vaccine could cause CRPS in a two-month timeframe. And there are some
decisions in which a special master has found similar timeframes to be medically reasonable. See,
e.g., Dixon-Jones, 2019 WL 7556374 (finding expert’s testimony persuasive who opined that
CRPS is expected “to develop rapidly, certainly within two months, probably within a month…”).
Because I have already determined that insufficient preponderant evidence was offered in this case
to establish that the HPV vaccine “can cause” the kinds of symptoms Ms. Hughes complained of,
or that she even likely suffered from CRPS, it is somewhat a moot point whether her symptoms
began in a medically acceptable timeframe. But I allow that the issue of timeframe is a closer one
than the other two prongs. Had Petitioner’s theory associating CRPS and the HPV vaccine been
more reliably established, the close showing on this prong would likely have been favorable to her
claim as well.

III. This Case was Properly Resolved Without a Trial

In ruling on the record, I am choosing not to hold a hearing. Determining how best to
resolve a case is a matter that lies generally within my discretion, but I shall explain my reasoning
(especially given the likelihood of further appeals in this matter).

Prior decisions have recognized that a special master’s discretion in deciding whether to
conduct an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to “afford[] each
party a full and fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 400–01 (citing Rule
3(b)). But that rule also includes the obligation of creation of a record “sufficient to allow review
of the special master’s decision.” Id. Thus, the fact that a claim is legitimately disputed, such that
the special master must exercise his intellectual faculties in order to decide a matter, is not itself
grounds for a trial (for if it were, trials would be required in every disputed case). Special masters

35
See Ex. 47 at 1.

45
are expressly empowered to resolve fact disputes without a hearing—although they should only
so act if a party has been given the proper “full and fair” chance to prove their claim.

In this case, no hearing was required to resolve the present claim in a manner fair to
Petitioner. Although Petitioner offered three expert opinions, only one (Dr. Miller’s) came from
an individual with enough professional credibility and expertise to be taken seriously. But the
opinions Dr. Miller’s three reports set forth were deficient and scientifically unreliable, as
previously discussed, thus deserving of little evidentiary weight. Accordingly, and even giving
that opinion as much credit as possible, as I have attempted to do, there was not enough evidence-
wise to carry the day for Petitioner—and no hearing would have increased the likelihood of a
more favorable outcome.

She has also had ample opportunity to substantiate her claim. My concerns about the
claim’s viability arose not only from my misgivings about the quality of Drs. DeMio’s and Lyons-
Weiler’s reports, but also from my review of the record itself—replete as it is with treater denials
of a vaccine relationship to her symptoms, along with reasoned proposals that those same
symptoms reflected somatization disorder. These concerns were brought to the attention of her
counsel over three years ago, and prompted the filing of Dr. Miller’s three reports. But those
reports did not resolve the problems with her claim, and they could not persuasively or credibly
rebut fact record proof that was unsupportive of her contentions. It thus cannot be said that my
misgivings about the claim’s strength were unexpectedly sprung on the Petitioner, or that she was
deprived of the chance to make a good case for entitlement given the medical record.

The fact that Respondent offered no experts of his own did not obligate me to give
Petitioners’ arguments (and/or the testimony of their experts) a credence that they did not merit,
or to hold a hearing. I am never required in any case before me to accept blindly the say-so of
any expert, pro or con, simply because the other side chooses not to counter an expert position
with a rebuttal opinion.36 I was able to draw on my experience in Vaccine Act cases generally (as
well as consider some relevant prior cases discussed above) to ascertain the significant limitations
undermining the expert opinions. Only one of Petitioner’s three experts, Dr. Miller, had baseline
credibility, but even his opinion (set forth in three reports) was insufficiently substantive to be
deemed preponderant. There also existed sufficient relevant decisions regarding HPV vaccine
and its injury-causative capacity to aid my analysis—and those decisions strongly suggested that
this case would produce the same outcome. The evidence simply did not even rise to a threshold
preponderant showing that would require Respondent expert input to resolve.

36
For example, if a petitioner called Dr. Andrew Wakefield, the discredited expert who testified in the Omnibus
Autism Proceeding for the petitioners, maintaining that autism is vaccine-caused in a “new” autism injury case, I
would not likely require Respondent to offer his own expert to counter Dr. Wakefield’s position (absent some truly-
novel research casting into doubt all that is known presently about the lack of a relationship between autism and
vaccines).

46
 Admittedly, in some cases weak evidentiary showings can still satisfy (if barely) a
petitioner’s preponderant burden if not countered or rebutted by the Respondent. See, e.g., Barone
v. Sec'y of Health & Hum. Servs., No. 11-707V, 2014 WL 6834557 (Fed. Cl. Spec. Mstr. Nov.
12, 2014) (ruling on record in favor of petitioner in case alleging GBS after the flu vaccine, where
Respondent did not offer expert report to rebut assertions of Petitioner’s expert); Gerhardt v.
Sec'y of Health & Hum. Servs., No. 09-180V, 2014 WL 4712690, at *11 (Fed. Cl. Spec. Mstr.
Aug. 29, 2014) (concise, undetailed expert opinion on causation offered by petitioner had not
been countered by any rebutting opinion filed by Respondent). But this case does not present
such circumstances, because the sufficiency of a bare evidentiary showing is more often than not
a function of the nature of the claim asserted. While a claim arising from well-trod ground (such
as one alleging GBS after the flu vaccine) might require a bit less scrutiny overall, this is not the
case where (as here) a claimant seeks to allege an injury that has been rarely compensated, based
on a theory I personally have been tasked with evaluating, but rejected, numerous times.

It cannot be disputed that Petitioner offered some evidence in support of her claim—and
the foregoing Decision should establish that this evidence was carefully scrutinized and
evaluated. But the expert reports she filed were overall too deficient to stand as reliable scientific
evidence that could push Petitioner’s showing across the preponderance “line,” and this remained
the case even after Petitioner was afforded the chance to obtain additional expert assistance. I
was not compelled to give such evidence extra weight solely because it was not challenged with
contrary expert opinions—the evidence offered by itself came nowhere close to constituting
preponderant proof in Petitioner’s favor.37

Overall, this case exemplifies precisely the kind of Vaccine Program claim that does not
warrant a hearing—and keeping in mind that petitioners always have the ultimate burden of proof
helps frame why this is so. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed.
Cir. 2013) (citations omitted); see also Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017)
(noting that Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under
the Vaccine Act” by a preponderance standard). Program claimants cannot obtain a damages
award simply by arguing that they were sickened after vaccination without record evidence
establishing their injury, within the Althen framework, and bulwarked by reliable medical or

37
The fact that the Federal Circuit (in ruling to permit the case’s reopening) observed the existence of some evidence
supporting Petitioner’s claim also does not compel the holding of a hearing—let alone suggest Petitioner’s showing
was anything close to evidentiarily preponderant. At the time I dismissed the claim, I expressly noted my conclusion
that reopening the matter would likely be futile. Moczek v. Sec. of Health & Human Servs., No. 16-930V, at 12, slip
op. (Fed. Cl. Spec. Mstr. Feb. 16, 2018). The panel disagreed, noting that Petitioner could point to some record
evidence of injury, and thus the claim could likely survive summary judgment (thereby undermining the conclusion
that relief from judgment would be futile). Moczek v. Sec. of Health & Human Servs., 776 Fed. Appx. 671, 675 (Fed.
Cir. 2019). But such comments did not amount to a weighing of the evidence, let alone a determination that Petitioner
would prevail based solely on the evidence allowed, whether the claim was resolved at hearing or on the record.
Having now performed that evidentiary balancing/weighing task (as I am compelled to do as special master), I find
the evidence in this case hardly supported holding a hearing.

47
scientific evidence, regardless of its form, on the capacity of the vaccine at issue to cause injury
consistent with that alleged. A record like this one—that does not corroborate the claim, but rather
shows treater after treater disputing the nature of Petitioner’s complaints, while also disputing
causation itself—unquestionably is unsupportive of entitlement. The length and detail of the
present decision should manifest the work I have undertaken to reach my conclusions—and also
should alleviate any lingering concerns that there was some fact issue or credibility determination
that might have turned the tide in Petitioner’s favor, had this matter been permitted to go to
hearing. No such outcome was possible based on the record.

CONCLUSION

Petitioner has been provided ample opportunity to substantiate her claim with reliable
evidence that the HPV vaccine can cause the sorts of injuries she alleges, and did so herein. But
she has not carried her burden. The deficiency of her showing is, if anything, highlighted by the
fact that Respondent did not offer his own expert opinions to undermine her case—Petitioner’s
showing by itself, while supported by some objective evidence, did not rise to the level of
preponderance such that rebuttal expert proof was necessary to resolve the claim.

Accordingly, this claim is dismissed. 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 accord with this
decision. 38

IT IS SO ORDERED.
s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master

38
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.

48