In the United States Court of Federal Claims
No. 16-930V
(Filed: June 4, 2021)1
(Re-filed: July 12, 2021)
**************************
KIRA HUGHES, National Childhood
Vaccine Injury Act, 42 U.S.C.
§§300aa-1 to -34 (2018);
Petitioner, Motion for review; HPV
vaccine; Off-table injury;
v. Injury in-fact; Dismissal
without a hearing; CRPS;
SECRETARY OF HEALTH POTS.
AND HUMAN SERVICES,
Respondent.
**************************
Braden Blumenstiel, Dublin, OH, for petitioner.
Kyle E. Pozza, Trial Attorney, Torts Branch, Civil Division,
Department of Justice, Washington, DC, with whom were Brian M. Boynton,
Acting Assistant Attorney General, C. Salvatore D’Alessio, Acting Director,
Heather L. Pearlman, Acting Deputy Director, and Alexis B. Babcock,
Assistant Director, for respondent.
OPINION
BRUGGINK, Judge.
In this action, brought pursuant to the National Childhood Vaccine
Injury Act, petitioner alleges that she suffers from pain and a heart condition
caused by vaccines she received on August 15, 2013. The case is before the
court on petitioner’s motion for review of the January 4, 2021 entitlement
1
This Opinion was held for fourteen days during which the parties were
permitted to propose to chambers any appropriate redactions. They did
not do so, and thus we reissue the decision without redactions.
decision denying compensation. Hughes v. Sec’y of Health & Human Servs.,
No. 16-930V, 2021 WL 839092 (Fed. Cl. Spec. Mstr. Jan. 4, 2021). The
motion is fully briefed, and oral argument is unnecessary. The Special
Master’s conclusion that the petitioner has not established that she suffers
from the injuries alleged was neither arbitrary nor capricious. We therefore
deny the motion for review.
BACKGROUND
I. Factual History
Petitioner’s relevant medical history begins on November 27, 2012,
when she visited the Wheeling Hospital in Wheeling, WV, complaining of
breathing problems, elevated heart rate, and dizziness. Two weeks later, Ms.
Hughes visited a community health center for headaches, heavy menstrual
period and again dizziness. Blood tests were normal, and the physician’s
assistant thought that the dizziness might have been the result of ear or optical
problems. On January 4, 2013, petitioner presented again at the health center
with knee pain and posterior bruising after falling down the stairs.
Cardiovascular and lung examinations were normal. The physician’s
assistant referred petitioner to physical therapy. On August 15, 2013, Ms.
Hughes visited the community health center again for immunizations. The
records of that visit state that she had a history of migraines. Petitioner
received the Meningococcal, Tdap, and HPV vaccines at that time.2
A week later, petitioner returned to the health center, complaining a
urinary tract infection, abdominal pain, and nausea. The treating doctor
recorded that the examination revealed no pain in petitioner’s legs. Pet.’s
Ex. 1 at 4 (ECF No. 6-1). Nor were skin rashes observed. A urine culture
came back negative. On August 23, 2013, Ms. Hughes visited an OBGYN
specialist, Dr. Walsh, again for pain in her abdomen. This visit included an
ultrasound to check for cysts, but none were found. The notes from that visit
also indicate that petitioner had by then complained twice of belly pain
during her menses. The following month, in September 2013, Dr. Walsh
proscribed oral contraceptives after Ms. Hughes again presented with lower
abdominal pain during her period.
2
“Tdap” is short for tetanus diphtheria-acellular-pertussis and “HPV” is
short for human papillomavirus.
2
On October 16, 2013, petitioner returned to Dr. Walsh, reporting leg
pain in both legs. The record of that visit shows that petitioner said that the
pain had begun three days prior. Pet.’s Ex. 24 at 3 (ECF No. 24-1). An
ultrasound examination of her legs was ordered and performed. It revealed,
however, nothing regarding the root of the pain. Id. at 5. Two days later,
Ms. Hughes went to the emergency room at the Monongalia General Hospital
in Morgantown, WV, for leg cramping, which she reported began three days
earlier, as well as for headaches, and back pain. The treating doctor at the
hospital conducted a physical exam, and then ordered blood testing and an
x-ray of petitioner’s legs. Nothing remarkable was found. The records of
that visit indicate no neurological deficits or other motor or sensory
problems. The doctor’s differential diagnoses included sciatica, spinal
stenosis, scoliosis, Guillian Barre syndrome, or a viral syndrome. Pet.’s Ex.
7B at 17 (ECF No. 7-5).
Petitioner’s complaints of leg pain continued. On October 22, 2013,
Ms. Hughes visited Dr. Joseph Li, M.D., for leg pain that she reported had
been ongoing for 10 days. Consistent with the hospital notes, she reported
no neurological or sensory problems other than an occasional limp in the
morning. She also told Dr. Li that she had stopped taking birth control pills.
Dr. Li’s examination revealed tenderness in her legs. A blood test showed
slightly elevated muscular enzymes, but she was negative for Lyme disease
and rheumatoid disorders. Pet.’s Ex. 3 at 8 (ECF No. 6-3); Pet.’s Ex. 7B at
7-11 (ECF No. 7-5). Dr. Li’s diagnosis was “myalgia,” and he prescribed a
muscle relaxant. Pet.’s Ex. 3 at 9.
One week later, petitioner was admitted to the West Virginia
University Hospital due to complaints of continued pain in her abdomen,
back, and legs. She stated that her pain level was a seven on a ten-point scale.
Pet.’s Ex. 6A at 16 (ECF No. 7-1). The examiners, and the treating doctor,
Dr. Jeffrey Lancaster, M.D., found no evidence of inflammatory disorders.
Id. at 15. Dr. Lancaster noted that fibromyalgia fit the vague description of
symptoms, but that it was unlikely given Ms. Hughes’ youth. Records from
that visit indicate that Ms. Hughes or her family asked about the possibility
that the Gardasil vaccine (HPV) could have caused the pain. Pet.’s Ex. 6B
at 25 (ECF No. 7-2). Ms. Moczek, petitioner’s mother, requested a toxin
screen to check for an adverse reaction, but the notes from Dr. Lancaster
indicate that he and other treaters looked into the components of the vaccine
and concluded that it was very unlikely to be the source of the pain. Pet.’s
Ex. 6A at 19. The hospital suggested an MRI to look for multiple sclerosis,
but petitioner’s family declined.
3
On October 31, 2021, petitioner was seen by a neurologist, Dr. Jodi
Lindsey, M.D. Dr. Lindsey found “giveaway weakness” in petitioner’s left
leg and overactive reflexes in both legs. Id. at 29. Dr. Lindsey’s finding was
that Ms. Hughes did not present a real weakness and that most of the
symptoms might be explained by chronic constipation. Id. at 32. This time,
an MRI was performed on petitioner, but it showed nothing extraordinary,
the same result as the previous lab tests. Petitioner was discharged the next
day. Dr. Lancaster wrote that there was no clear cause of Ms. Hughes’ pain
and that, given the extensive nature of her examinations and testing, anxiety
might be to blame. Id. at 36.
On November 4, 2013, petitioner underwent a brain and spine MRI.
Nothing remarkable was discovered other than a “subtle loss of height of disc
space at the L4-5 level.” Ex. 3 at 11 (ECF No. 6-3). On November 6, 2013,
petitioner went to Dr. Li for a follow-up visit. Dr. Li’s notes indicate that,
after reviewing all available records and lab reports, including the MRI
results, there was a consensus among the treating physicians that no physical
etiology of petitioner’s pain had been found. Notable was the observation
by Dr. Li that, despite his light touch causing her pain during examination,
Ms. Hughes was able to take on and off “skin tight jeans” without pain. Pet.’s
Ex. 3 at 13. He also recorded that, although petitioner complained of pain in
the mornings, to the point where she could not walk to school, in the
afternoon, in his office, she was walking normally, and her movements were
fluid. Id. at 11. The notes also reveal that Ms. Hughes was upset and cried
when discussing returning to school although she stated that she did want to
return. Id. at 13. Upon leaving Dr. Li’s office, Ms. Hughes’ gait became
unsteady and her legs stiff.
Ms. Moczek again proposed that the HPV vaccine might be to blame,
but Dr. Li’s notes indicate that her daughter’s symptoms were not consistent
with the side effects recorded for Gardasil in the medical literature. Id. at 16.
Petitioner cried when Dr. Li suggested that the pain might be mental in
origin. His notes from the visit include that the “active problems” were
“myalgia and myositis” and “somatization.” Id. at 12. Dr. Li suggested
counseling. The record of the visit also indicates that Dr. Lancaster had
agreed that petitioner could try alternative medicine, and Dr. Li provided a
referral to a practitioner.
Early the next year, petitioner followed up with the neurologist, Dr.
Lindsey, at an outpatient visit. The notes of that visit indicate that the leg
4
pain continued and that severe headaches had begun since the hospital stay
in 2013. Petitioner also reported continued constipation and poor sleep.
Petitioner “den[ied] any clear noted social stressors.” Pet.’s Ex. 6C at 30
(ECF No. 7-3). Petitioner and her mother reiterated their vaccine-induced
pain theory, this time including additional detail regarding an “inflammatory
process.” Dr. Lindsey concluded otherwise, however, noting neither
evidence of an inflammatory issue after repeated blood testing nor any
neurological problems. Id. at 32. The doctor recommended “Cognitive
Behavioral Therapy” to deal with stress and pain somatization. Id.
Also around this time, petitioner began to consult with Dr. Phillip
DeMio, one of petitioner’s experts in this case. The intake forms for Dr.
DeMio’s practice, located in Worthington, OH, indicated pain, headaches,
and constipation. See Pet.’s Ex. 10A at 2-3 (ECF No. 7-7). Some of
petitioner’s relevant medical history was also provided, including the
administration of the HPV vaccine. Those forms also state that petitioner
presented an “uneven smile,” which Dr. DeMio indicated might be indicative
of bell palsy. Id. at 4. In the box labeled “Adverse reactions and allergies to
drugs, supplements, foods, anything else,” “Gardasil-adverse reaction” was
listed. Id. at 3.
Dr. DeMio’s records are very difficult to read as they are often
handwritten and dates or frequently missing or are indecipherable. He
continued to treat Ms. Hughes through 2016. A chronological recital is both
impossible and unnecessary. Over his several years of involvement with
petitioner, he recommended, which were performed, a host of blood tests for
various diseases, genetic conditions, and hormonal levels. He prescribed an
extensive list of homeopathic remedies, vitamins, and minerals. See id. at
11-23. Antiviral medications were also recommended. Most of the tests
were negative or unremarkable other than one set of antibodies indicative of
a viral infection from the herpes family.
On March 19, 2014, Ms. Hughes returned to Dr. Li with the same pain
complaints, reporting that her myalgia began in October 2013. Petitioner’s
mother informed Dr. Li that Dr. DeMio had thought that Lyme disease might
be to blame. Dr. Li explained that petitioner had already tested negative for
Lyme disease. Dr. Li again recorded the difference between the pain reported
and petitioner’s demeanor and reactions during the exam. Pet.’s Ex. 3 at 22.
He advised that Dr. DeMio’s testing was unnecessary and again proposed
somatization as the likely diagnosis. Petitioner requested a rheumatoid
referral, which Dr. Li agreed to provide.
5
On March 31, 2014, petitioner went to a clinic at the West Virginia
University Hospital for her chronic pain, headaches, fatigue, and sleep
problems. The treating physician, Dr. Ahmad Al-Huniti, M.D., noted the
lack of a clear etiology and thus concluded a potential “psychogenic” root
and/ or “complex regional pain syndrome, chronic fatigue syndrome, Ehler’s
Danlos/POTS.”3 Pet.’s Ex. 6C at 211.
Ms. Hughes had a rheumatology examination at the Nationwide
Children’s Hospital in Columbus, OH, on April 22, 2014. The records of
that visit indicate that petitioner’s mother explained that her daughter’s pain
began in August 2013, two months earlier than previously reported. Pet.’s
Ex. 5 at 6 (ECF No. 6-5). The treaters at the Children’s Hospital noted
hypermobility and excessive pain and fatigue. Psychological causes were
also proposed as potential etiology and anxiety treatment recommended. Id.
at 67-68.
The next month, petitioner visited a genetics clinic back at the West
Virginia University Hospital. Following examination, Dr. Tara Narumanchi,
M.D., did not recommend genetic testing. She did recommend hydrotherapy
and a cardiology evaluation with a “tilt table test” due to “concern of POTS.”4
Ex. 6C at 225.
In June 2014, Ms. Hughes visited Dr. Freeda Flynn, M.D., in Saint
Clairsville, Ohio for “HPV Complications.” Pet.’s Ex. 23 at 18 (ECF No.
22-1). The printed record of that visit indicates a 15-minute office visit and
an electrocardiogram. Id. at 19. The diagnoses listed on the two-page printed
record were an unspecified mycoplasma infection and a heart murmur. Id.
Dr. Flynn’s handwritten notes on the next page also indicate a viral infection
and “possible Gardasil reaction.” Id. at 20.
Dr. Flynn continued to see and order tests on petitioner through 2016.
These included a cortisol serum test in August 2014, chest x-rays and an EKG
in September 2014, and spinal x-rays in August 2016. See id. at 21-26. Dr.
3
“POTS” is short for postural orthostatic tachycardia syndrome.
4
The Special Master noted that it was not clear why Dr. Narumanchi included
POTS as an issue during the genetics consultation other than the fact that
petitioner’s mother had previously brought it up to other treating physicians
and Dr. Al-Huniti’s notations in March 2014. 2021 WL 839092 at *7.
6
Flynn authored a general letter, dated September 11, 2014, stating that
petitioner was in her care for “Gardesil [sic] Syndrome” and a bacterial
infection. Id. at 27. The letter stated that it was in Ms. Hughes’ best interest
to “remain home bound” until December 19, 2014. Id.
Also in September 2014, petitioner again saw Dr. DeMio, who
prescribed pain medication, but records indicate that she did not take the
medicine for fear of nausea. Pet.’s Ex. 17 at 9 (ECF No. 8-7). Dr. DeMio
saw Ms. Hughes again that month and opined that Ms. Hughes might have
Lyme disease and recommended a slate of treatments consisting of antivirals,
antibiotics, and various nutritional supplements. Id. at 17. After attending
and dancing at a wedding in mid-September, Ms. Hughes presented to the
emergency room at the Wheeling Hospital for heart palpitations. An EKG
and chest x-ray were unremarkable, however. Pet.’s Ex. 18 at 14-15 (ECF
No. 12-1).
In January 2015, Dr. DeMio issued a letter similar to Dr. Flynn’s. In
it, he stated that he was treating petitioner for several diseases and disorders,
among which were Lyme disease, autoimmune problems, and metabolic
disorder. Pet.’s Ex. 10A at 44 (ECF No. 7-7). His recommendation was a
limited school schedule.
After filing the lawsuit, petitioner also submitted a two-page record
from the Cleveland Clinic Neurology Department, dated August 15, 2019.
That document states that petitioner was referred by a Certified Nurse
Practitioner for back pain and sciatica. The document indicates “associated
diagnos[e]s” of POTS and insomnia. Pet.’s Ex. 47 (ECF No. 76-1). The
Special Master found the probative value of that document to be limited,
however, due to the lack of explanation or other corroborative testing. 2021
WL 839092 at *8.
II. Procedural History
On August 3, 2016, petitioner’s mother, on behalf of her then-minor
daughter,5 timely filed a petition for compensation under the National
Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§300aa-1 to -34 (2018)
(“Vaccine Act”). Shortly thereafter, petitioner filed the medical records
discussed above and other records as they became available. Petitioner also
5
Ms. Hughes was eventually substituted as the petitioner when she reached
the age of majority.
7
initially filed expert reports from Dr. DeMio and and Dr. James Lyons-
Weiler. The Special Master stated in his opinion that he reviewed the reports
and instructed petitioner to provide a third expert report due to misgivings he
had about the experts based on his prior experience with them and the
substance of their reports. 2021 WL 839092 at *17. A minute order entered
on July 31, 2017, directed such by September 8, 2017. It is not clear from
the opinion below nor the docket entries if the Special Master’s substantive
doubts were communicated nor how petitioner knew what the third expert
report was to address.
Although petitioner did eventually submit several reports from a third
expert, Dr. Michael Miller, M.D., on September 29, 2017, the Special Master
dismissed the petition for failure to prosecute due to repeated failures to file
documents on time. ECF No. 38. He denied reconsideration on February
16, 2018. ECF No. 58. Petitioner then filed a motion for review, which we
denied. ECF No. 63. Those decisions were reversed, however, by the
Federal Circuit in 2019. Moczek v. Sec'y of Health & Human Servs., 776 F.
App’x 671 (Fed. Cir. 2019) (holding that dismissal for failure to prosecute
was an abuse of discretion due to the nature of the Vaccine Act’s intent to
create a less formal litigation process).
After remand, respondent moved for an order to show cause why the
case should not be dismissed on the basis that the petition, records, and expert
reports were insufficient to meet the Vaccine Act’s causation standard.
Petitioner opposed on the basis that the motion was a thinly veiled attempt at
summary judgment and that it was inappropriate to grant on the record
already established. The Special Master agreed and denied the motion on
February 19, 2020. ECF No. 77. The Special Master advised, however, that
the government could revisit the issue by moving for a ruling on the record.
Id. at 4. The Special Master reiterated that he found petitioner’s case
particularly unpersuasive and that he was unlikely to ultimately order
compensation.
Respondent moved for a ruling on the record in May 2020. Petitioner
opposed and submitted a final expert report from Dr. Miller. Respondent
submitted neither expert opinion nor any other form of evidence for the
Special Master to consider.
8
III. Petitioner’s Experts
Petitioner presented reports from three experts. The first, Dr. DeMio,
as summarized above, also examined Ms. Hughes during her complained of
symptoms prior to the action at bar.
A. Dr. DeMio
Dr. DeMio has an M.D. from Case Western Reserve University and
completed residencies in pathology and emergency medicine. He now
primarily treats Lyme disease and autism spectrum disorders but does see
patients with chronic pain, such as Ms. Hughes. He has authored several
papers on chronic conditions such as arthritis, gout, and general
inflammatory problems. He has spoken at conferences about spinal injuries
and Lyme disease. Pet.’s Ex. 49 at 3 (ECF No. 76-8) (DeMio CV).
His report in this case describes petitioner’s health as generally “very
good” prior to her immunizations in 2013. He details that, at his initial
examination, he found tender areas in her legs, differences in her tendon
reflexes, mottled skin, and an otherwise unexplained “emotional liability.”
Pet.’s Ex. 11 at 1 (ECF No. 8-1). After testing, he treated Ms. Hughes for
immune problems and “metabolic dysfunction.” Id. at 2. He believes that
petitioner’s health rapidly declined after the vaccines and that she has now
been rendered permanently disabled. He draws a causal link between them.
His report states that the vaccines administered to Ms. Hughes
contained elements which elicited an “intense long-lasting reaction[] in the
body.” Id. These adjuvants, microbial DNA, and microbial proteins, in his
view, can and did create a “pathologic response” damaging end organs by
way of cellular damage in those tissues, opines Dr. DeMio. Id. He cites an
article from the Journal of Investigative Medicine High Impact Case Report
from 2014.6 This article appears in the record as Pet.’s Ex. 36 (ECF No. 48-
2). Dr. DeMio rules out other causes based on petitioner’s test results. He
further singles out the HPV vaccine as the likely perpetrator based on his
opinion that it was insufficiently tested and its relationship to other pediatric
cases. Pet.’s Ex. 11 at 2. The report concludes that a psychological
6
Tomljienovic, 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).
9
explanation for petitioner’s pain was unlikely because symptoms, such as
muscle wasting, would not be explained by somatization. Id.
The Special Master, in his background section of the entitlement
decision, prefaces his detailed summary of Dr. DeMio’s report with the
conclusion that the expert was unqualified to offer his opinion on the
vaccine’s causation. The Special Master cites four other instances in which
special masters have reached similar conclusions contrary to Dr. DeMio’s.
2021 WL 839092 at *9.
B. Dr. Lyons-Weiler, PHD
Dr. Lyons-Weiler has a Master’s degree in Zoology from Ohio State
University and a PHD in ecology, evolution, and conservation biology from
the University of Nevada in Reno. His resume lists his current position as
the CEO and Director of The Institute for Pure and Applied Knowledge, a
nonprofit aimed at reducing human pain and suffering through biomedical
research. Pet.’s Ex. 21 at 1 (ECF No. 15-4); see also 2021 WL 839092 at
*10(citing http://ipaknowledge.org/ (last visited October 21, 2020)). After
examining Dr. Lyons-Weiler’s website, the Special Master concluded that,
although Dr. Lyons-Weiler had a personal and professional interest in
vaccine safety and molecular processes involved, his training left him “ill-
equipped to offer the opinion he fashioned for this matter.” 2021 WL 839092
at *10.
The opinion offered by Dr. Lyons-Weiler centers on his investigation
of the safety of the HPV vaccine in general, especially as it involves its
manufacture. The report also states the general proposition that vaccines can
trigger autoimmune disorders, which the opinion below accepted as
generally recognized among Special Masters. Pet.’s Ex. 20 at 14 (ECF No.
15-3). Dr. Lyons-Weiler went on to state that studies to the contrary
involving the HPV vaccine were flawed. See, e.g., id. at 14-15. He also
discusses several case studies purportedly drawing the link between HPV
vaccines and “adverse neurological and immune reactions.” Id. at 1. As the
Special Master noted, however, those studies involve arthritis, lupus,
neuropathy, and somatoform disorders. Id. at 2. The Palmieri article7
proposes a theory of autoimmune inflammatory syndrome brought on by
7
B. Palmieri et al., Severe Somatoform and Dysautonomic Syndromes after
HPV Vaccination: Case Series and Review of Literature, Immunol. Res.
(2016), filed as Pet.’s Ex. 82 (ECF No. 93-3).
10
vaccine adjuvants, which the Special Master noted in his background
discussion had been routinely rejected by him and his colleagues at the court.
A list of Special Master decisions was then included. 2021 WL 839092 at
*11 n.16.
Other cited literature in Dr. Lyons-Weiler’s report was dismissed as
similarly untrustworthy, previously having been found unconvincing by
other Special Masters. Id.8 The report then goes on to describe a process of
injury to petitioner caused primarily by similarity between vaccine molecules
intended to induce an autoimmune response and Ms. Hughes’ own tissues
whereby the antigens produced by her body attacked her own cellular
structures due to their similarity to the vaccine’s structures. Pet.’s Ex. 20 at
3. This process, states Dr. Lyons-Weiler, would have been made worse by
the HPV vaccine’s aluminum adjuvants, especially since multiple vaccines
were administered at the same time. Id. at 4.
Dr. Lyons-Weiler focused on one result from an October 2013 blood
test of petitioner which showed one heightened inflammatory marker. This
Bun/Creatine ratio was evidence to Dr. Lyons-Weiler of “vaccine-induced
spondylosis.” Id. at 6-7. He also found significant the timing of the onset of
symptoms after the immunizations. This “long onset” after vaccination was,
according to Dr. Lyons-Weiler “established in the medical literature.” Id. at
4. He cites a study in which six individuals suffered a variety of symptoms,
some nonspecific and others more concrete, indicating Lupus disease after
the HPV vaccine. Id. (citing M. Gatto, Human Papillomavirus Vaccine and
Systemic Lupus Erythematosus, 32 Clin. Rheumatol. 1301–1307 (2013)).
That case study was not in evidence, however. As the Special Master noted,
Dr. Lyons-Weiler’s report does not explicitly draw the link between the
Gatto study and the two-month gap between vaccination and onset in this
case. It is also unclear how a diagnosis of spondylosis supports petitioner’s
theories.
C. Dr. Miller
Dr. Miller is a professor of pediatrics at Northwestern University and
a staff member at the Children’s Hospital of Chicago. Pet.’s Ex. 27 (1st
Miller Rep.) (ECF No. 41-2). He prepared and petitioner submitted three
8
E.g., Brinth et al., Suspected Side Effects to the Quadrivalent Human
Papilloma Vaccine, 62(4) Dan. Med. J. A5064, filed as Pet.’s Ex. 61 (ECF
No. 91-2).
11
reports in this matter. To summarize all three, he diagnosed Ms. Hughes with
complex regional pain syndrome (“CRPS”), although he noted she also
suffered from POTS since vaccination. His first report explains that Dr.
Miller has treated children with CRPS and has evaluated in his practice
whether it and other autoimmune diseases were causally related to vaccines.
Id. at 3.
Dr. Miller’s first report states his general opinion that the onset of
symptoms and subsequent course of events “is diagnostic for post-vaccine
Adverse Event,” although he recognizes that other causes for CRPS are
possible. Id. at 1. His opinion, however, is that only the vaccines could have
caused this injury to petitioner given the fact that the testing administered
since the vaccine “excluded all other possible causes.” Id. He goes on to
describe CRPS as a neuropathy (nerve damage) and states that Gardasil “has
been associated with neuropathy and related neurological side effects” in
medical journals. Id. at 2. He recognizes that the precise biological
mechanism has not been identified but postulates that the HPV vaccine
“causes an immune response in which . . . [white blood cells] mount an
antibody response directed against viral antigens . . . and [adjuvants] in the
vaccine.” Id. These white blood cells “experience a case of mistaken
identity” which causes them to attack “parts of their own body.” Id. This,
in turn causes swelling and even scarring (fibrosis) of these nerve tissues. Id.
This caused untreatable pain, according to Dr. Miller, because the scarring is
not treatable with anti-inflammatories. Id. The third of four pages in his
report discusses four case studies in medical literature in which patients
experienced neurologic pain or encephalomyelitis after HPV vaccination.
Dr. Miller’s second report, submitted in response to the motion to
show cause, attempted to support his earlier opinions by including some
additional literature support for the idea that Gardasil can cause CRPS. See
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
as Pet.’s Ex. 48C (ECF No. 76-5). Dr. Miller also further opined that
petitioner’s symptoms supported a diagnosis of POTS as well, which he
deemed a second adverse reaction to the vaccine. He supported this assertion
with a European study which followed six young women who developed
POTS within two months following HPV immunization. See S. Blitshteyn,
Postural Tachycardia Syndrome Following Human Papillomavirus
Vaccination, 21 European J. of Neurology 135–139, filed Pet.’s Ex. 48D
12
(ECF No. 76-6). That article stated that investigation into a causal
relationship was warranted. Id. at 138.
Dr. Miller’s second report also took issue with the somatization
diagnoses in petitioner’s contemporary records by opining that Ms. Hughes
did not experience the persistently high level of anxiety required for such a
diagnosis. Pet.’s Ex. 48 at 2 (ECF No. 76-2). He also concluded that
petitioner’s medical records precluded a diagnosis of CRPS prior to
administration of Gardasil, which he also found indicative of the casual
relationship between the two. Id. at 1.
Dr. Miller’s third report, Pet.’s Ex. 50 (ECF No. 87-1), submitted in
August 2020, is his most robust and is responsive to respondent’s motion for
a ruling on the record. The seven-page report begins with the statement that
Dr. Miller has diagnosed Ms. Hughes with both CRPS and POTS caused by
the HPV vaccine. He then details the symptoms associated with CRPS,
which he states is well recognized “to be triggered by autoimmune diseases.”
Pet.’s Ex. 50 at 1. He then lists the diagnostic criteria known as the
“Budapest criteria.” Id. at 1-2. These include disproportionate pain to any
inciting event and at least one symptom that is sensory, vasomotor, edema,
or motor, and must include “a sign in two or more of the following categories:
(1) Sensory . . . (2) Vasomotor . . . (3) Edema . . . (4) motor.” Id. Finally,
“no other diagnosis . . . better explains the patient’s signs and symptoms”
according to Dr. Miller. Id. at 2.
Dr. Miller continues that CRPS is the appropriate diagnosis because
Ms. Hughes experienced continuing pain disproportionate to the
administration of the vaccine, hyperalgesia and hypoesthesia (sensory
symptoms), abnormal skin coloration (vasomotor), sweating (edema), and
changes to her hair, skin, and nails along with moto deficits. Id. The next
page goes through the same rubric for POTS, which he offers is also an
autoimmune disorder. The report states that petitioner’s diagnosis of POTS
by the Cleveland Clinic and her display of a variety of symptoms associated
with POTS establish, in his view, the correctness of a diagnosis with the
syndrome. Id. at 2-3.
Dr. Miller also again offers that somatization is inapposite as a
diagnosis because petitioner does not fit the diagnostic criteria of “excessive
thoughts, feelings, or behaviors related to the somatic symptoms” which
manifest as either “disproportionate and persistent thoughts about the
seriousness of one’s symptoms,” high levels of persistent anxiety about them,
13
or “excessive time and energy “devoted to these symptoms or health
concerns.” Id. at 4. The diagnostic criteria for somatization were also filed
as Pet.’s Ex. 50E (ECF No. 87-6). This state is persistent, more than six
months in duration. Id. Dr. Miller rejects somatization because no
competent psychologist or psychiatrist diagnosed petitioner, and he found no
evidence that Ms. Hughes’ reports of her symptoms were disproportionate or
excessive to the point of anxiety. Id.
Dr. Miller concluded his report by explaining that the other diagnoses
by petitioner’s treating physicians were inaccurate because neither Drs.
Lancaster nor Li are immunologists, neurologists, nor rheumatologists. Id.
at 6. Thus, as pediatric and internal medicine practitioners, they were out of
their proverbial wheelhouses when dismissing the vaccines as a causal agent
of Ms. Hughes’ ailments, according to Dr. Miller.
IV. The Special Master’s Decision
By the time the case was ripe for adjudication on the merits,
petitioner’s theory had become one of Gardasil-caused immune reaction by
molecular mimicry causing CRPS and POTS. According to her experts, not
only was the HPV vaccine dangerous and causal here, but her symptoms
were consistent with those diagnoses, and the onset of pain and associated
issues was consistent with the diagnosis. The Special Master disagreed on
all points.
The Special Master exhaustively detailed the medical records, expert
opinions, and medical literature presented by petitioner. Although prior
rejections of similar theories were cited in the background discussion of these
materials, each aspect of petitioner’s case was treated on its own as well as
weighed collectively and compared with petitioner’s medical records and
examined under the Daubert factors for indicators of reliability. E.g., 2021
WL 839092 at *22 (stating that the Special Master would apply Daubert v.
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993)). As the Special
Master explained, in this court, the Daubert analysis is used, not as a
gatekeeping tool, but instead as an analytical lens for testing the reliability of
expert testimony and opinion. Davis v. Sec’y of Health & Human Servs., 94
Fed. Cl. 53, 66-67 (2010).
The opinion below also explains the Special Master’s consideration
and citation to prior vaccine decisions involving the same experts or similar
theories of causation. These are, he states, cited to “establish common
14
themes as well as demonstrate how such prior determinations impact my
thinking on the present case.” 2021 WL 839092 at *23. Although not
controlling and leaving room for the possibility of a different result here, the
Special Master states that he would be remiss to ignore prior cases and their
reasoning given that Special Masters draw upon their experience in deciding
these matters. “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.” Id.
The opinion goes on to also explain that the Special Master’s job
includes the rejection of expert opinion outside of the expert’s subject matter
expertise. A circumstance that the Special Master found himself in in this
case. Id. at *24-25. And, given the discussion above, he states that it would
hardly be “arbitrary” to point out when such a determination had been made
about an expert previously. Id. at *25.
The analysis of the evidence begins with a significant review of HPV
vaccine-caused theories made to the Special Masters. Id. at *25-26. He
explains that, while not controlling, he “referenced them to emphasize [his]
great familiarity with the arguments about the HPV vaccine commonly made
. . . .” Id. at 25. The more familiar the Special Master became with these
theories, he explains, the less necessary a hearing on entitlement in similar
cases has appeared to him. Id. One was unnecessary here, he concluded,
given the Special Master’s own experience previously rejecting Dr. DeMio’s
“Gardasil Syndrome” theory. Id. (citing McKown v. Sec’ y of Health &
Human Servs., No. 15-1451V, 2019 WL 4072113, at *7 (Fed. Cl. Spec. Mstr.
July 15, 2019)).
Next, the Special Masters’ treatment of CRPS as a vaccine-caused
injury was summarized with examples of entitlement decisions for and
against petitioners. The key distinction drawn between the present case and
prior successful ones was the presence of vaccine-induced trauma “close-in-
time to vaccination that later resulted in CRPS” as contrasted with the less
specific precipitation of symptoms over time here. Id. at 26.
The opinion then turns to petitioner’s burden. The first, and outcome-
determinative conclusion, was that petitioner had not established by a
preponderance of evidence that she suffered from POTS or CRPS. The
Special Master rejected Dr. Miller’s conclusion that petitioner’s symptoms
fit within the criteria for CRPS. The Special Master found instead that the
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contemporaneous evidence suggested close-in-time symptoms associated
with menses and a urinary tract infection, followed by the development of
more general pain in the back and legs two months later. Id. at 27. The
extent of testing and number of examinations performed on petitioner with
no suggestion of CRPS or of a trauma near-in-time to the vaccine suggested
to the Special Master that that the CRPS diagnosis was unreliable.
Central to his holding was the “absence of corroboration of a regional
pain syndrome” other than less-than-reliable and unqualified medical
opinions from Dr. DeMio and Dr. Flynn. Id. Also very important to the
Special Master was Dr. Li’s notes that Ms. Hughes’ symptoms would abate
at times during her visit when she was not being examined for them and when
she disrobed and then put her tight pants back on. This, to the Special Master,
was evidence that the pain symptoms were not unrelenting, a necessary
finding under the Budapest Criteria. Id. Lastly, on the issue of CRPS, the
lack of any suggestion of CRPS from the treating doctors prior to genesis of
the vaccine theory, was similarly decisive for the Special Master. Id. He
afforded no weight to Dr. Miller’s suggestion that the lack of an alternative
etiology offered by the treating doctors should be deemed evidence of a
vaccine cause because it is the petitioner’s burden establish an injury. Id.
On the question of whether petitioner suffered from POTS, the
opinion details the lack of substantiation in the records of any of the common
symptoms of POTS in the months immediately following the vaccine. Id.
Dr. Al-Huniti’s listing of POTS as a potential explanation more than six
months after vaccine administration was afforded little weight given lack of
supporting evidence and the extensive testing performed on Ms. Hughes,
including cardiac testing. Id. The Special Master also noted the fact that a
tilt table test was never performed, which, according to the petitioner, is the
“gold standard of POTS diagnosis.” Pet.’s Ex. 50D at 1 (webpage of the
Cleveland Clinic regarding POTS). The Cleveland Clinic’s 2020 write up,
which listed POTS as a potential explanation, was discounted as insufficient
considering the other record evidence or lack thereof. 2021 WL 839092 at
*27.
The opinion goes on to treat each of the Federal Circuit’s factors for
causation and rejects each in this case as unsupported by the record. It is
unnecessary to detail each of those holdings, however, because we agree with
the Special Master on the first point, that it was reasonable to conclude that
petitioner has not established an injury in fact. There was insufficient proof
of either CRPS or POTS.
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DISCUSSION
This court has jurisdiction to review the Special Master’s decision
under the Vaccine Act. 42 U.S.C. § 300aa-12. Our review is deferential. We
will only overturn an entitlement decision if it is “arbitrary, capricious, an
abuse of discretion, or otherwise not in accordance with law.” Id. § 300aa-
12(e). When the Special Master has considered the relevant evidence and
articulated a rational basis for the decision, reversible error is “extremely
difficult to demonstrate.” Hines v. Sec’y of Health & Human Servs., 940
F.2d 1518, 1528 (Fed. Cir. 1991). We do not reweigh the evidence or make
new reliability or credibility determinations. Porter v. Sec’y of Health &
Human Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011). Those are for the
Special Master.
A petitioner may seek compensation for “any illness, disability,
injury, or condition” sustained or significantly aggravated by a vaccine. 42
U.S.C. §§ 300aa-11(c)(1) to 13(a)(1)(A). When a petitioner seeks
compensation for an injury other than those listed on the Vaccine Injury
Table, petitioner must prove causation in fact. Althen v. Sec’y of Health &
Human Servs., 418 F.3d 1278, 1278 (Fed. Cir. 2005) (citing 42 U.S.C. §
300aa-13(a)(1)(A)). Petitioner must show that the vaccination caused the
injury by proving three elements by a preponderance of the evidence: “(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 a proximate temporal relationship
between vaccination and injury.” Id. Identification of an injury is
prerequisite to the Althen inquiry, however. Broekelschen v. Sec’y of Health
& Human Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010). If the evidence does
not support the injury alleged, causation cannot be established, and the
petition fails for lack of proof. Id. In other words, without proof of the
asserted injury, the theory of causation is a priori unreliable and unsupported
by the evidence, and it is unnecessary to go through the remaining Althen
factors.
Here, we find just such a case. Although the Special Master
recognized Dr. Miller as sufficiently qualified to offer his opinion on the
subject—a qualification not afforded to Dr. DeMio nor Dr. Lyons-Weiler—
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he found Dr. Miller’s conclusions unsupported or contraindicated by the bulk
of the contemporaneous medical records.9
Petitioner responds on review that there was ample evidence of
symptoms that demonstrate the propriety of Dr. Miller’s diagnoses. Ms.
Hughes’ health took a c-turn in the months following vaccination, and the
differential diagnoses are sufficient under the Daubert standard to infer
causation, avers counsel. The documented pain in Ms. Hughes’ legs and
back is sufficient to support a diagnosis of CRPS, according to petitioner,
and the cardiovascular symptoms recorded, such as sleeping problems and
heart palpitations, carry the burden to support a finding of POTS. Pet.’s Mot.
for Review 6. Petitioner points to the records of Dr. Flynn and the two-page
record from the Cleveland Clinic as support of her position. Lastly,
petitioner argues that she meets the Budapest criteria for CRPS and the
diagnostic criteria for POTS, as listed by Dr. Miller. Procedurally, petitioner
also finds error in the Special Master’s decisions not to hold a hearing and
not to require respondent to file a report on entitlement.
We find these arguments, although not completely without record
support, unavailing because they do not address the central point of the
Special Master’s holding. Even were we to agree that the evidence is, in a
vacuum, sufficient to support a diagnosis of CRPS and POTS, the Special
Master clearly considered all of it but disagreed as to the conclusion. He did
not miss the import of Dr. Miller’s application of the diagnostic criteria. It
is in fact those criteria that provide sound footing for the Special Master’s
contrary conclusion. He compared the criteria with Ms. Hughes’ records.
He found they did not fit. That is within his purview under the Vaccine Act.
It is insufficient to point out contrary evidence when the Special Master is
vested with the authority to weigh it, which he did. Dr. Flynn’s, Dr. DeMio’s,
and the Cleveland Clinic’s records were considered and given less weight
than other contemporaneous records. Dr. Li’s observations were particularly
damning. The Special Master’s consideration of all of it makes clear that he
was not missing any facts or failing to understand the points made.
9
Even were we to find that these conclusions were arbitrary and capricious,
an issue we need not reach nor presented by the motion for review, the
conclusion would not change. The comparison of the record to the diagnostic
criteria was supported by the record and not unreasonable. Additionally, the
opinions of Drs. DeMio and Lyons-Weiler were directed more at the question
of how the HPV vaccine would have caused the injuries asserted, not to
establish the injuries themselves.
18
Specifically, on the criteria for CRPS, the onset of pain two months
after immunization and Dr. Li’s observations provide the evidence necessary
to reach the conclusion that the Special Master did. Dr. Li’s notes
contraindicate the criteria of unrelenting pain under the Budapest criteria.
This also answers petitioner’s criticism that it was arbitrary not to require
evidence from respondent. It was unnecessary to have opinion or other
medical literature to weigh against that submitted by petitioner because her
own medical records were sufficient ground for the Special Master’s
conclusion to find purchase. 10
On the issue of POTS, the record is even clearer that the Special
Master was well within the zone of reasonableness in reaching his
conclusion. In sum, although plaintiff suspected cardiac problems and
sought treatment for them, none were ever discovered by testing, nor was the
single most determinative test for POTS ever performed. It was thus not
irrational to find the record unavailing for petitioner on this diagnosis.
Although the discussion in the opinion of the Special Master’s role
and consideration of prior results achieved by the same experts or by similar
causation theories was unnecessary and distracting, his holding regarding the
injury is not irrational. In the final analysis, his conclusions were based on
the evidence, or in some respects, the lack of it, in this case. The Special
Master considered all the record evidence. He examined and explained why
the literature presented by petitioner was insufficient to bridge the gaps in
the record. He applied the very diagnostic criteria supplied by petitioner’s
expert and compared them with petitioner’s medical records. More is not
asked for on review.
CONCLUSION
Because the Special Master did not err in holding that petitioner had
not established by preponderant evidence the injuries alleged, the petition
was properly dismissed. Accordingly, petitioner’s motion for review (ECF
No. 96) is denied. The Clerk of Court is directed to enter judgment
accordingly.
10
We also do not find error in the decision not to hold a hearing. Petitioner
has not explained how the evidence would have been different or why a
credibility determination would be necessary to support the Special Master’s
holding that the diagnoses of CRPS and POTS do not fit with the evidence.
A hearing was unnecessary in these circumstances.
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s/Eric G. Bruggink
ERIC G. BRUGGINK
Senior Judge
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