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

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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.

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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

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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) o

This text is long and has been trimmed here. Open the source document for the complete record.