# Yalacki v. Secretary of Health and Human Services

> United States Court of Federal Claims · March 6, 2019

URL: https://www.frixlaw.com/law-library/cases/4374299

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** March 6, 2019
- **Precedential status:** Unpublished
- **Opinion:** Opinion
- **Judges:** Brian H. Corcoran
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/4374299

## How later opinions describe it (automated extraction)

- noting that Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under the Vaccine Act” by a preponderance

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-278V
(Not to be published)

************************* Special Master Corcoran
MELANIE YALACKI, *
*
* Filed: January 31, 2019
Petitioner, *
* Entitlement; Hepatitis B
v. * Vaccine; Chronic Fatigue
* Syndrome (“CFS”); Postural
SECRETARY OF HEALTH AND * Orthostatic Tachycardia Syndrome
HUMAN SERVICES, * (“POTS”); Autoimmunity;
* Medically-Acceptable Timeframe.
Respondent. *
*
*************************

Richard Gage, Richard Gage, P.C., Cheyenne, WY, for Petitioner.

Sarah C. Duncan, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION DENYING ENTITLEMENT1

On April 10, 2014, Melanie Yalacki filed a Petition under the National Vaccine Injury
Compensation Program (the “Vaccine Program”2), alleging that the Hepatitis B (“Hep B”) vaccine
she received on June 2, 2011, caused her to suffer chronic fatigue syndrome (“CFS”) and/or
postural orthostatic tachycardia syndrome (“POTS”). Pet. at 1–2 (ECF No. 1).

1
Although this Decision has been formally designated “not to be published,” it will nevertheless be posted on the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.
2
The 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.
A hearing in this matter was held on January 22–23, 2018. After consideration of the record
and testimony provided at hearing, I find that Petitioner is not entitled to a compensation award.
As discussed in more detail below, the Petitioner has not offered a reliable theory explaining how
the Hep B vaccine could cause either of her alleged injuries. In addition, there are legitimate
questions as to whether Petitioner actually suffered from CFS or POTS—but assuming that she
did, the medical record does not support the conclusion that the vaccine likely caused either injury.
The vaccination at issue was simply too remote in time from the record evidence most supportive
of either diagnosis, while the symptoms she points to that occurred closer in time to vaccination
either do not support her alleged injuries or can be explained by her pre-vaccination medical
history.

I. Factual Background

Pre-Vaccination History

Mrs. Yalacki’s medical history reflects numerous occasions on which she sought a
physician’s care. In the three years preceding the June 2011 vaccination in question, Petitioner
sought treatment for a wide variety of injuries that ranged from minor to serious. These include
(but are not limited to) muscle and joint pain, eye problems, dehydration, skin issues, and upper
respiratory infection (“URI”) symptoms.3 See generally Ex. 1, filed Apr. 11, 2014 (ECF No. 5-1).
Some of these doctor’s visits were objectively reasonable—for example, Petitioner sought care for
whiplash, a cervical sprain, and lumbar strain resulting from an April 30, 2010 car accident. Id. at
288. But overall, Mrs. Yalacki’s medical records reveal that she regularly obtained medical
assistance for general health concerns (some of which, in retrospect, do not appear to have merited
immediate attention).

The pre-vaccination medical record also establishes that the Petitioner intermittently
complained of symptoms very similar to those she allegedly experienced after receiving the Hep

3
See, e.g., Ex. 1 at 3–4 (ganglion cyst and wrist tendonitis due to hair twisting in May 2008); id. at 28 (bilateral hand
and finger pain in July 2008); id. at 55–56, 64–65, 68 (deep joint and muscle pain in the upper extremities and a scratch
on her eye from her fingernail in September 2008); id. at 80–82, 89–90 (bilateral hand and finger pain, tingling, and
burning, back pain and inflamed eyelid glands in October 2008); id. at 94–96, 102 (bilateral arm pain, hair pulling,
URI symptoms, and body aches in November 2008); id. at 104, 106–07, 110 (eye floaters, right eye “turning in,” and
feeling dehydrated after being in a sauna in December 2008); id. at 111–14 (severe body aches in January 2009); id.
at 145–46 (weeks of bilateral foot tingling and toe and calf cramps during exercise in February 2009); id. at 189–92,
197–99 (acne and neck strain in June 2009); id. at 238–39 (ankle injury in November 2009); id. at 247–49 (left knee
pain and metatarsalgia in February 2010); id. at 253, 270–73, 302–03 (acne; bilateral knee, foot, and ankle pain in
March 2010); id. at 282–83 (shin contusion in April 2010); id. at 288–92, 306–09, 321–23, 329–31, 420–21, 430–31
(car accident-related lower back and neck pain in May, June, and December 2010); id. at 316–17, 337–40, 343–45
(corneal dystrophy, dry eye syndrome, and groin pain after bike riding in June 2010); id. at 353–54, 359–60 (finger
injury and back pain in July 2010); id. at 404–05 (lower back pain in November 2010); id. at 454–58, 475–76 (allergic
reaction to bed covers, jaw pain, and lower back pain in February 2011); id. at 496–97, 500–01 (stomach ache and
lower back pain in March 2011); id. at 504–10, 523–34 (cough, shortness of breath, and lower back pain in April
2011); id. at 529–30, 539–40 (lower back pain and request for valium refill in May 2011).

2
B vaccine. For example, on June 24, 2008 (three years prior to the vaccination in question), Mrs.
Yalacki sought treatment for dizziness, nausea, shakiness, and near syncope after consuming
several doughnuts. Ex. 1 at 9–13. A few months later, on October 2, 2008, Petitioner complained
of fatigue, dizziness, nausea, and increased heart rate after taking Vicodin. Id. at 70. On four
occasions in January 2009, she reported fatigue, diffuse muscle aches, “burning in [her] chest,”
leg pain, and concern that she had lupus attributable to chemicals in her new car. Id. at 119–20,
126–27, 129–33. And two years later, on February 25, 2011, after being diagnosed with mild
anemia, Petitioner reported that she was “freaking out” and that she had “felt like passing out a
couple of times.” Id. at 482–83.4

Receipt of Hepatitis B Vaccine and Purported Immediate Reaction

On June 2, 2011, Mrs. Yalacki (then thirty-three years old) saw Laura Jarrell, M.D., at the
Kaiser Permanente5 facility in Lakewood, Colorado, to discuss treatment for chronic back pain.
Ex. 2 at 5–7, filed Apr. 11, 2014 (ECF No. 5-2). On the same date, Petitioner received her third
Hep B vaccine (the first two having been administered without incident on May 9, 2000, and
November 7, 2000). Id. at 6, 18, 39; Ex. 1 at 444.6

Almost immediately after, Mrs. Yalacki began reporting to treaters that she was
experiencing an adverse reaction. She phoned the Kaiser Permanente nurse advice line on the
afternoon of June 2, 2011, requesting a call back regarding body aches and fatigue. Ex. 2 at 16.
The nurse returned her call at 5:35 p.m., at which time Mrs. Yalacki stated that she was very tired
and had muscle aches, attributing her symptoms to the Hep B vaccine she had received earlier that
day. Id. Less than one hour later she called the advice line a second time, repeating her concern
that she “fe[lt] bad” after having received the Hep B vaccine. Id. at 17. She called a third time the
next morning, again expressing worries about a “vaccine reaction,” that she pinpointed as having

4
Besides seeking care for physical problems, the record reveals that in the years prior to vaccination, Petitioner also
discussed concerns regarding her mental health with treating physicians. See, e.g., Ex. 1 at 207–09 (July 15, 2009
report of depression and concern regarding short term memory loss and disorganized thoughts, which had begun years
before); id. at 367–69 (July 29, 2010 report of severe depression after stopping breastfeeding); id. at 380–81
(September 24, 2010 report of problems coping with anxiety and depression for many years, but declining
antidepressants or a mental health practitioner referral). However, Petitioner maintains that any such problems were
under control immediately prior to her receipt of the Hep B vaccine, and that she was in fact doing well mentally at
that time. Pet’r’s Post-Hr’g Br. at 2, filed Aug. 20, 2018 (ECF No. 96); Tr. at 237, 241, 392–93; see also Ex. 1 at 295
(“depression stable”), 360 (“depression stable”), 405 (anxiety stable with one dose of valium per week).
5
It appears from the medical record (which shows that Petitioner saw numerous different practitioners with the same
practice focus—for example, family medicine or cardiology) that Mrs. Yalacki did not regularly see a single primary
care physician. This may have been because her insurance was in the form of a health maintenance organization that
allowed her to see any professional available at the time.
6
It is unclear why eleven years elapsed between Petitioner’s second and third Hep B vaccinations. The Centers for
Disease Control and Prevention recommend a one-month gap between the first and second doses of Hep B, and a two-
month gap between the second and third. Immunization Schedules, Centers for Disease Control and Prevention
(Mar. 5, 2018), https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html.

3
begun within an hour and a half of the vaccine’s administration, and leaving her bed-ridden and
dizzy. Id. at 18. Based on such reports, the call log set forth an assessment of “reaction to
immunization.” Id.

Later in the day on June 3, 2011, Mrs. Yalacki returned to Dr. Jarrell based upon the alleged
reaction she had experienced the day before. Ex. 2 at 22–24. Her exam, however, was normal, with
no evidence of muscle weakness. Id. at 23. Dr. Jarrell’s diagnosis was fatigue as a possible side
effect of the vaccination, “though not compatible with allergic reaction,” adding that an unrelated
viral illness or Petitioner’s pre-vaccination anemia might be contributory factors to the symptoms
Petitioner reported. Id.

Despite Dr. Jarrell’s initial assessment, Petitioner continued to express concerns about an
ongoing reaction. Days after her appointment with Dr. Jarrell, Mrs. Yalacki called the nurse advice
line on June 6, 2011, with similar complaints about muscle weakness and fatigue that she reported
had lingered without improvement. Ex. 2 at 34. She reiterated her view that the Hep B vaccine was
the source of her symptoms. Id. That evening, a different physician, Li-Fen Lee, M.D., evaluated
Petitioner. Id. at 38. Noting that she was unable to keep her eyes open during the exam due to
fatigue, Dr. Lee ordered bloodwork. Id.

Based on Mrs. Yalacki’s demonstrated fatigue and her indications that she did not feel she
could adequately care for herself under the circumstances, Dr. Lee proposed that she go to Exempla
St. Joseph’s emergency room (“ER”). Ex. 2 at 39. There, Petitioner again reported five days of
marked fatigue since receiving the Hep B vaccine. Ex. 5 at 4, filed Apr. 11, 2014 (ECF No. 5-5).
Her exam was normal, however, and ER treaters did not propose that the vaccine was causal (or,
for that matter that any other “typical reaction to vaccine” was present). Id. at 5. Petitioner was
discharged that same evening with a diagnosis of fatigue. Id. at 5–7.

In the following days, Mrs. Yalacki continued to express alarm about her purported vaccine
reaction. Specifically, on June 7 and June 15, 2011, Petitioner again reported complaints to Dr.
Jarrell similar to what she had previously reported. See Ex. 2 at 47, 56–57. In response, Dr. Jarrell
contacted an infectious disease specialist, and reported to Petitioner that this specialist had
preliminarily stated that although mild fatigue could occur in association with vaccination,
Petitioner’s claimed symptoms were not consistent with what was ordinarily reported. Id. at 51.
Dr. Jarrell proposed additional bloodwork to check for evidence of an infection or inflammatory
disease. Id.

At her visit with Dr. Jarrell on June 15, 2011, Petitioner brought in “multiple web sites and
blog sites” for Dr. Jarrell to review about “stories of people who claim to be sick themselves or
know someone who has either been sick or died after receiving the hep B shot.” Ex. 2 at 56. Dr.
Jarrell, however, again expressed doubt that Petitioner’s symptoms had anything to do with the

4
vaccination, noting that Petitioner had received it before without incident, and that her blood tests
had raised no notable concerns. Id. at 57. She nevertheless referred Petitioner to an infectious
disease specialist for further evaluation. Id. at 57, 69. Prior to that visit, Petitioner saw Heather
Burton, M.D., on June 16, 2011. After recounting symptoms and a history much as before, Dr.
Burton proposed depression or anxiety as an explanation for Mrs. Yalacki’s condition, although
Petitioner declined to pursue mental health treatment. Id. at 87.

At. Dr. Jarrell’s referral, Mrs. Yalacki saw infectious disease specialist Miguel Mogyoros,
M.D., on June 20, 2011. Ex. 2 at 67–69. She recounted the same post-vaccination history and
symptoms as before, with Dr. Mogyoros noting that Petitioner had been “looking up vaccine side
effects in the internet and is convince[d] her symptoms are due to this vaccine.” Id. at 67.
Consistent with prior treaters, Dr. Mogyoros expressed the view that the Hep B vaccine was not
likely the source of Petitioner’s symptoms, and noted as well that bloodwork revealed no
identifiable other problems, but that Mrs. Yalacki was “not very interested” in his opinion and
seemed convinced the vaccine was causal of her alleged symptoms. Id. at 68. Any blood testing
Dr. Mogyoros performed was also negative. Id. at 72. He did, however, agree to report the claimed
reaction to the Vaccine Adverse Event Reporting System (“VAERS”). Id. at 68.

Although numerous treaters informed Petitioner in the same month she received the Hep
B vaccine that (a) they could not identify the source of her symptoms, and (b) they did not deem
it likely that the vaccine was causal of those symptoms, Mrs. Yalacki continued to seek treatment,7
including self-admission to two different hospital ERs where she informed providers of her
suspicions that the vaccine was related to her illness. See, e.g., Ex. 6 at 3–4, filed Apr. 11, 2014
(ECF No. 6-1) (June 16, 2011 visit at Porter Adventist Hospital ER; neurology work-up
recommended); Ex. 5 at 14–20 (June 18, 2011 visit to Exempla St. Joseph ER). Again, no etiology
was proposed for Petitioner’s symptoms, nor did treaters identify the Hep B vaccine as causal
(despite Petitioner’s assertions to the contrary).

After the second of these ER visits, Mrs. Yalacki received a more in-depth neurologic
work-up from Lynsee Lang, M.D., on June 22, 2011. Ex. 2 at 104–08. Around this time, Petitioner
also began to report experiencing multiple convulsion spells per day. Id. at 106. Dr. Lang noted,
however, that prior neurologic evaluations performed at ERs had discounted seizure as an
explanation for Petitioner’s condition, and an MRI produced normal results. Id. The exam was

7
Treaters also continued to propose to Mrs. Yalacki that her symptoms likely had a psychological component—an
assessment that she rejected. Thus, on June 30, 2011, Petitioner returned to Dr. Jarrell and admitted that she was
depressed, but did not want to be treated for fear of being “pigeon-holed,” and disputed the conclusion that she was
“unstable,” maintaining her belief (based on her own independent research) that the Hep B vaccine explained her
symptoms. Ex. 2 at 123–24. Dr. Jarrell nevertheless “strongly recommended” that Petitioner treat her depression
(based upon the opinion that doing so would ameliorate her symptoms), but Petitioner refused. Id. at 124. The
following month, another neurologic consult produced the opinion that Petitioner’s spells were pseudoseizures (which
are deemed psychological in origin rather than evidence of neurologic injury). Id. at 155–56; Dorland’s Illustrated
Medical Dictionary 1546 (32nd ed. 2012) (hereinafter “Dorland’s”).

5
otherwise unremarkable, as was an electroencephalogram Dr. Lang subsequently ordered. Id. at
107, 117. Dr. Lang concluded that Petitioner’s spells were unlikely true seizure activity “and could
be entirely unrelated to vaccination other than [as] a possible stressor that could have exposed this
phenomenon.” Id. at 108. Despite this work-up, Petitioner that same day requested additional
factors about her purported symptoms be added to the existing VAERS report, to “make sure other
people don’t get sick from this vaccine.” Id. at 79.

Defining Alleged Reaction as CFS or POTS

As Petitioner continued to seek medical guidance in the summer of 2011 for her alleged
vaccine-caused symptoms, she also began proposing her own characterizations of those symptoms
or exploring alternative explanations.

Thus, on July 8, 2011, Julie Cohen, M.D., consulted on Petitioner’s case. Ex. 2 at 136–37.
As before, Petitioner recounted a litany of post-vaccination symptoms, including several she had
not previously reported: cognitive delay, difficulty remembering basic words, and fainting. Id. at
136. Dr. Cohen proposed some repeated testing or seeking second opinions (for example, with
respect to the neurologic consult that Petitioner had received the month before but disputed). Id.
at 142. A few days later, however, on July 11, 2011, Mrs. Yalacki called Dr. Cohen’s office and
stated that she believed she was suffering from CFS. Id. at 146. The next day, she repeated this
assertion (although the record of her subsequent call uses the formal medical term “myalgic
encephalomyelitis” in lieu of CFS). Id. at 150.

On July 28, 2011, Dr. Cohen evaluated Petitioner for syncopal episodes that she reported
had occurred every other day for a week. Ex. 2 at 192. Dr. Cohen’s examination of Mrs. Yalacki
was unremarkable, however, and she concluded that Petitioner did not have CFS, recommending
instead that Petitioner obtain a Holter monitor evaluation8 and echocardiogram to determine an
explanation for her syncopal episodes. Id. at 192–93. Subsequent testing over the next month for
Petitioner’s convulsion-like spells confirmed that they did not meet the clinical criteria for
seizures. Ex. 8 at 25–26, filed Apr. 11, 2014 (ECF No. 6-3). Mrs. Yalacki nevertheless “continued
to hold on to the idea that these [spells] occurred as a result of the HBV vaccination (which we
feel is not the case).” Id. at 23.

On September 8, 2011, Mrs. Yalacki saw cardiologist Joseph Abruzzo, M.D. Ex. 2 at 283–
84. Again she repeated her history since receiving the Hep B vaccine. Id. at 283. The Holter
monitor test revealed sinus rhythm with heart rate ranges between 50 and 140 beats per minute
(“BPM”), and the echocardiogram was normal. Id. Dr. Abruzzo’s initial evaluation, after review
of her file and the substantial testing she has already undergone (none of which had been positive

8
Holter monitors are attached to the body and measure a subject’s heart rate over twenty-four-hour periods. Tr. at 37.

6
for any understood etiology), was that Petitioner possibly was experiencing a “[s]yndrome of
autonomic neuropathy” that was at least temporally associated with the Hep B vaccine
administration. Id. at 284.9 To test this impression, Dr. Abruzzo proposed that Mrs. Yalacki treat
what could be an orthostatic condition with “aggressive water and salt intake,” and also scheduled
her for a tilt table test (in which an individual’s orthostatic readings are continuously taken while
the subject is secured to a flat table that is then tilted up)10—the test deemed most reliable for
diagnosing POTS (see Eduardo E. Bennaroch, Postural Tachycardia Syndrome: A Heterogeneous
and Multifactorial Disorder, 87 Mayo Clinic Proc. 1214, 1220 (2012), filed as Ex. H Tab 1, June
30, 2016 (ECF No. 42-8))—for later that month. Id. The tilt table test was performed on September
20, 2011, as scheduled, and although it was terminated after thirteen minutes due to leg pain, Dr.
Abruzzo (observing that “the HR [heart rate] and BP [blood pressure] did not vary in an important
way from baseline”) concluded that it revealed no evidence of autonomic dysfunction. Ex. 5
at 84.11 Petitioner’s heart rate increased by only ten BPM over the exam period. Id.

Treater Support for Petitioner’s CFS/POTS Diagnoses

Despite the aforementioned records (which are largely unsupportive of the conclusion that
Petitioner suffered from either CFS or POTS), Petitioner did later receive treater evaluations
supportive of some of these diagnoses—although it is not clear from the record how
comprehensive or reliable these diagnoses are.

On September 27, 2011, Petitioner presented to a new primary care physician (“PCP”),
Anisa Moore, M.D. Ex. 2 at 335–36. Dr. Moore’s examination of Mrs. Yalacki produced only
normal results, but based on the history she reported (and without any indication that Dr. Moore
had reviewed the expansive prior medical record), Dr. Moore diagnosed her with CFS. Id. at 335.
In so doing, Dr. Moore noted her view that, except for the temporal requirement, Mrs. Yalacki met

9
The record from this same time period memorializes a call Mrs. Yalacki made to the nurse line in which she
represented that Dr. Abruzzi had definitively informed her that her symptoms were attributable to the Hep B vaccine,
and asked that this be documented in her record. Ex. 2 at 291. The nurse taking the call reviewed the same record
referenced above, and on that basis responded that in fact all Dr. Abruzzo had stated was that there was a temporal
relationship with the vaccine. Id.
10
The standard tilt table test entails the patient remaining in a supine position for twenty minutes, followed by ten
minutes tilted upright, and that the heart rate and blood pressure should be measured minute by minute. Tr. at 265–
66. Preparation for the test begins the day before, to ensure that the patient has consumed sufficient fluids and has not
consumed alcohol or medications that might interfere with the results. Id. at 265.
11
Also in September of 2011, a rheumatologic work-up of Petitioner (intended to evaluate arthralgias that had been
allegedly present since the Hep B vaccination) found no evidence of any joint inflammation or damage, and no signs
to suggest inflammatory arthritis, connective tissue disorder or evidence of serum sickness-like disorder. Ex. 2 at 312–
13.

7
the Center for Disease Control’s (“CDC”) criteria for CFS.12 Id. Dr. Moore did not express an
opinion as to the causal role of the Hep B vaccine, although she forthrightly did not rule out the
possibility. Id.13 Dr. Moore subsequently urged Mrs. Yalacki to obtain treatment for CFS from a
specialist, but it is not evident from the record that Petitioner ever acted on this recommendation.
Id. at 359.

Another primary care physician Petitioner consulted in October 2011—Leslie Pearson,
M.D.—also concurred that Petitioner’s self-reported symptoms described CFS, although Dr.
Pearson added that a “MH [mental health] disorder” was likely contributing to Petitioner’s
symptoms. Ex. 2 at 402–03. Like Dr. Moore, moreover, Dr. Pearson stressed the importance of
obtaining proper specialized treatment for CFS (including cognitive therapy and graduated
exercise), and Dr. Pearson refused to sign short term disability paperwork for Petitioner without
Petitioner’s agreement to actively pursue such treatment. Id. at 402.

In January 2012, Petitioner saw yet another PCP, Andrea Fedele, M.D. (who, as discussed
below, also testified at hearing). Ex. 2 at 425–28. Based on Petitioner’s subjective symptoms and
a review of the CDC criteria, Dr. Fedele confirmed the CFS diagnosis, adding that “it is most
consistent by history as due to the vaccination received on 6/2/2011.” Id. at 428. As with Dr.
Moore’s diagnostic assessment, however, it does not appear from the January record of the visit to
Dr. Fedele that she reviewed or took into account Petitioner’s detailed prior history (although she
did purport to have reviewed prior testing results). See id. at 428.

Petitioner’s condition improved substantially beginning in early March of 2012, with fewer
body aches and less fatigue, as Dr. Fedele recognized. See Ex. 2 at 457–58. By June of that year,

12
The CDC states that a CFS diagnosis requires the following: 1) “clinically evaluated, unexplained persistent or
relapsing chronic fatigue that is of new or definite onset (i.e., not lifelong), is not the result of ongoing exertion, is not
substantially alleviated by rest, and results in substantial reducation [sic] in previous levels of occupational,
educational, social, or personal activities;” and 2) “concurrent occurrence of four or more of the following symptoms:
substantial impairment in short-term memory or concentration; sore throat; tender lymph nodes; muscle pain; multi-
joint pain without swelling or redness; headaches of a new type, pattern, or severity; unrefreshing sleep; and post-
exertional malaise lasting more than 24 hours,” all of which must persist or recur over six consecutive months and
may not have predated the fatigue. Ex. 125 at 1, filed Nov. 21, 2017 (ECF No. 75-2). The CDC also includes a list of
conditions that exclude a diagnosis of CFS, including major depressive disorders with psychotic or melancholic
features, among others. Id.
13
Later on, however, Petitioner took a more pointed approach in challenging Dr. Moore’s reluctance to link the Hep
B vaccine to her symptoms. On October 7, 2011, Mrs. Yalacki and her husband returned to Dr. Moore. Ex. 2 at 358–
59. The record from this visit reveals Dr. Moore’s recollection that Petitioner was “very invested in having the treating
physician and Kaiser Permanente as a corporation acknowledge that the hepatitis B vaccine caused p[atien]t’s
symptoms and condition,” but when Dr. Moore attempted to emphasize that she considered it more important to
provide good treatment to Petitioner than to identify the etiology of a condition that could not be “undone” (as the
vaccine’s damage, if any, occurred when it was administered the prior June), Petitioner and her husband became very
angry and accusatory, insisting that their own research revealed an association, and questioning Dr. Moore’s
competence to opine on the possibility of vaccine causation. Id. at 359.

8
Petitioner was able to do basic tasks such as getting groceries, and while she experienced some
fatigue, she noted that resting helped her feel better. Id. at 465. And then at a September 19th visit,
Petitioner reported that she was doing “much better” and was “far more functional.” Id. at 472.
She was able to resume teaching first grade that fall. Id.

Mere days after that September 19, 2012 visit, however, Petitioner’s health took a dramatic
turn for the worse. See Ex. 2 at 478. She called Kaiser Permanente on September 24th, complaining
of a headache, body aches, and fatigue. Id. Dr. Fedele followed up via telephone the following
day, at which time Mrs. Yalacki reported that she had experienced a “crash” four or five days prior.
Id. at 480. She again called the Kaiser Permanente line on September 28th, stating that she had
experienced exhaustion, body aches, headaches, and pain under her arms since receiving the Hep
B vaccine in June 2011. Id. at 484. However, Dr. Fedele did not perceive Petitioner’s condition to
be as bad as it had been the previous year upon returning her call later that afternoon. Id. at 485.

Subsequent visits to various physicians did not confirm the CFS diagnosis provided by
previous treaters. For example, in November 2012 Mrs. Yalacki saw another neurologist, Julie
Seibert, M.D. (a referral from Dr. Fedele) complaining of heart palpitations. Ex. 2 at 537–39. Dr.
Seibert did not believe that Petitioner had any neurologic problems, however, nor did she see
evidence of autonomic dysreflexia, although she proposed that Petitioner consult with a
cardiologist on the latter point. Id. at 538. Mrs. Yalacki saw Dr. Abruzzo again, in February 2013,
at which time he reviewed a newer echocardiogram and Holter monitor results, noting that both
were normal. Id. at 625. He reaffirmed that Petitioner’s September 2011 tilt table test had been
negative for any possible autonomic dysfunction. Id.

Petitioner nevertheless continued to seek referrals for new neurologists and cardiologists
(based in part on her own POTS and autonomic dysreflexia research) to obtain second and third
opinions. Ex. 2 at 630. To that end, on February 26, 2013, Mrs. Yalacki saw neurologist Karen
Rollins, M.D., who, noting Mrs. Yalacki’s normal neurologic testing results, felt she did not have
anything to add. Id. at 635–40. Dr. Rollins did, however, opine that (a) Petitioner did not have
POTS, (b) her symptoms were unrelated to her June 2011 vaccination, and (c) further medical
treatment was unnecessary. Id. at 636. Significantly (and in contrast to some treater records that
were more deferential to Petitioner’s claims, without independently verifying assertions made
about her history), Dr. Rollins’s treatment record includes a more expansive walkthrough of
Petitioner’s medical history post-vaccination, including her ER visits. Id. at 637–40.

The following month, on March 5, 2013, Mrs. Yalacki saw another cardiologist, Adam
Betkowski, M.D. Ex. 2 at 665–68. He took note of Petitioner’s negative tilt table test results, but
performed his own in-clinic check of blood pressure and heart rate, measuring both while sitting
and while standing. Id. at 667. He determined that her blood pressure and heart rate changes going
from one posture to the other were enough to “suggest possibly [POTS] with possibly borderline

9
orthostatic hypertension.” Id. Dr. Betkowski noted her heart rate as around 70 BPM during a seated
physical exam, which increased to 120 to 130 BPM when she stood up. Id. Dr. Betkowski
concluded that Petitioner “likely” had POTS, but recommended additional testing (including
another tilt table test) in order to confirm the supposition. Id. at 668. Later that same month,
Petitioner’s plasma norepinephrine levels were tested, but found to be well within the normal
range. Ex. 3 at 7, filed Apr. 11, 2014 (ECF No. 5-3).14

It does not appear from the record that a second tilt table test was ever performed despite
Dr. Betkowski’s recommendation. However, one year later (after Petitioner had moved to
California from Colorado), in March 2014 Mrs. Yalacki saw a new PCP, Rebecca Smith, M.D.
Ex. 12 at 1–3, filed June 18, 2014 (ECF No. 9-2). At her initial visit with Dr. Smith, Petitioner
reported that she had in fact been diagnosed with POTS based on a tilt table test, that she had CFS,
and that she had become “very ill” on June 2, 2011 after receiving a Hep B vaccine. Id.

One month later, Petitioner saw cardiovascular physician Brett Berman, M.D. Ex. 13 at 1–
3, filed June 27, 2014 (ECF No. 10-1). She reported that she had been diagnosed with POTS in
March 2013 (presumably relying on Dr. Betkowski’s assessment based solely on standing/sitting
measurements of heart rate and blood pressure). Id. at 1. She also informed him of the prior tilt
table test performed in 2011, although Dr. Berman deemed the results “unclear” based on
Petitioner’s recollections. Id. Dr. Berman’s examination revealed a regular heart rhythm with
mitral regurgitation, and an echocardiogram performed at this time revealed “sinus rhythm at 93
with increased voltage and possible left ventricular hypertrophy with T-wave changes possibly
secondary to repolarization abnormalities.” Id. Dr. Berman’s assessment was orthostatic
hypotension, unspecified chest pain, mitral valve insufficiency/aortic valve stenosis, and
nonspecific abnormal echocardiogram. Id.

In the spring of 2014, Petitioner visited Robert Gillespie, M.D., on two occasions. Ex. 12
at 5–7, 33–35. At her first visit with him on April 18th, she informed him that she had previously
been diagnosed with POTS. Id. at 5. Dr. Gillespie performed a sit-stand test, upon which Mrs.
Yalacki’s heart rate increased by twenty-eight BPM while her blood pressure remained unchanged.
Id. at 7. Based on her self-reported history and the sit-stand test results, Dr. Gillespie opined that
she had POTS. Id. Noting that she attributed her condition to receipt of the Hep B vaccine, he
remarked that he was unfamiliar with the idea that the vaccine could be causal. Id. At her second
visit with Dr. Gillespie on May 22, 2014, Petitioner’s heart rate increased from seventy-one to
eighty-eight BPM in a sit-stand test, with her blood pressure again remaining unchanged. Ex. 12
at 34. Dr. Gillespie reiterated his view that she had POTS at this time. Id.

14
It does not appear from the medical records filed in this case that Petitioner’s plasma norepinephrine levels were
tested at any time post-vaccination before March 24, 2013. As explained by Dr. Low at hearing, such results would
have been helpful in showing whether Petitioner had POTS earlier in time. See Tr. at 277–78.

10
At Dr. Gillespie’s referral, Petitioner went to yet another cardiologist, Elizabeth Noll,
M.D., on July 2, 2014. Ex. 15 at 1–4, filed Aug. 6, 2014 (ECF No. 12-2). After performing an
initial review of the records and an examination, Dr. Noll noted that “[a]lthough the diagnosis of
POTS has been questioned, the patient has also demonstrated significant increase in heart rate
during office exams when placed in an upright position.” Id. at 1. Dr. Noll’s assessment accepted
the prior POTS diagnosis (“currently carries a diagnosis of [POTS]”), but she acknowledged that
other testing (the Holter monitor, for example) did not support the diagnosis, and that the 2011
inconclusive tilt table test “reportedly did not demonstrate the typical heart rate increase seen
within the initial phase of upright tilt,” leading her to suggest that the test should be repeated. Id.
at 3.

No further records of Petitioner’s treatment since July 2014 have been filed. It also does
not appear that Petitioner ever underwent a second tilt table test.

II. Fact and Expert Witnesses

A. Petitioner’s Witnesses

1. Mrs. Melanie Yalacki

Petitioner testified both as part of her direct case and again in rebuttal. She maintained
(somewhat contrary to the record as discussed above, at least with regard to the years immediately
prior to vaccination) that before receipt of the third Hep B shot she was “very energetic” and had
a “zest for life.” Tr. at 236. She noted in particular that she had always been motivated in her work
as a teacher. Id. at 237–39. She also testified about her passions for exercise and spending time
with family. Id. at 240. She also recalled the enthusiasm and energy she had when planning a party
for her mother prior to vaccination. Id. at 241.

After the June 2011 vaccination, however, Petitioner began to feel weak and “really tired”
in a manner that she said was unusual. Tr. at 240. Her purported change in energy and overall
health status prevented her from pursuing her career. In particular, she recalled that by the summer
of 2012 (one year after the vaccination in question) she “started to feel a little better,” and was able
to obtain accommodations from her school administration to allow her to go back to work. Id. at
242. However, her health problems made it too hard to do so. Id. at 243.

In her rebuttal testimony, Mrs. Yalacki attempted to distinguish her pre-vaccination health
status from thereafter. Thus, she recalled that immediately before the June 2011 vaccination, she
was in the process of ending the school year (which, as a teacher, meant closing down her
classroom), preparing for and hosting her son’s seventh birthday party, and organizing the

11
aforementioned party for her mother. Tr. at 391–93. She exercised on the morning she received
the Hep B vaccination, and overall she characterized her health at that time as “stellar.” Id. at 394.

2. Dr. Andrea Fedele

Dr. Fedele was the first of two treating physicians to offer testimony on Petitioner’s behalf.
She also provided a one-page opinion letter. See Ex. 17, filed Apr. 7, 2015 (ECF No. 22-1). She
testified about the circumstances of her treatment of Mrs. Yalacki in 2012–13, and specifically the
bases for the CFS diagnosis she made.

Dr. Fedele practices family medicine in Colorado for Kaiser Permanente (in particular, the
KP Foundation Health Plan), the health provider from whom Petitioner received much of the
treatment at issue in this case. Tr. at 61–62, 104.15 She provided medical services to Mrs. Yalacki
between January 2012 and April 2013. Id. at 63.

Although Dr. Fedele has seen patients with CFS in her time as a physician, treatment of
the condition is not a regular feature of her medical practice, and she admittedly lacks specialized
expertise with it. Tr. at 104. She also has no specialized training in immunology, and Mrs. Yalacki
was not her patient at the time of the 2011 vaccination at issue. Id. at 105–06.

At hearing, Dr. Fedele was questioned about her treatment of Mrs. Yalacki. Tr. at 63–83.
She confirmed that she had diagnosed Petitioner with CFS slightly more than six months after Mrs.
Yalacki received the Hep B vaccine. Id. at 63. Overall, she emphasized that her personal
examination of Mrs. Yalacki revealed (or confirmed, based on Petitioner’s self-reporting) fatigue,
post-exertional malaise, unrefreshing sleep, cognitive impairment, and orthostatic symptoms—all
of which are clinical indicia of CFS. Id. at 64, 81–84.16 She obtained those indicia, however, from
computer diagnostic information maintained by Kaiser Permanente, as opposed to her own
individual expertise in treating others with CFS. Id. at 65, 105. She also noted that, although at
certain points in 2012 Mrs. Yalacki appeared to be recovering from her CFS symptoms, these

15
Dr. Fedele’s curriculum vitae was not filed in this case.
16
On cross examination, Respondent took issue with the record evidence purported to support certain of Dr. Fedele’s
findings with respect to CFS. Thus, Dr. Fedele allowed that shortness of breath was not equivalent to post-exertional
fatigue (something Petitioner reported experiencing). Tr. at 93. She was also asked several questions about the strength
of evidence supporting the conclusion that Petitioner was experiencing “unrefreshing sleep,” acknowledging that
although Petitioner reported being bed-ridden, this was more consistent with generalized fatigue. Id. at 97. In another
instance, Dr. Fedele seemed to interpret being bed-ridden as proof of unrefreshing sleep. Id. at 74 (discussing October
22, 2012 record). Ultimately, however, because CFS can be diagnosed based on multiple criteria, I do not find that
the evidentiary strength of the CFS diagnosis turns on whether in fact Petitioner actually experienced “unrefreshing
sleep.”

12
symptoms soon returned in a way that Dr. Fedele found to be consistent with CFS. Id. at 71–72
(discussing records pertaining to successive visits to Dr. Fedele in September 2012).

Dr. Fedele’s testimony featured a review of all medical records documenting her treatment
of Petitioner throughout the relevant time period. See generally Tr. at 63–83. She frequently read
her notations in particular records aloud without additional comment. See, e.g., id. at 68, 72, 73,
75–79. However, in some instances she provided context for her notes. For example, Dr. Fedele
recalled that as of her first visit with Petitioner (on January 10, 2012), she did not have the benefit
of a complete set of Petitioner’s prior medical records. Id. at 103, 106; see also Ex. 2 at 425.
Although Dr. Fedele stressed that her own examinations of Petitioner revealed symptoms of CFS,
she admitted that records establishing similar symptoms before vaccination would have been
relevant to the accuracy of her diagnosis. Tr. at 96. Her diagnosis was also in some respects based
on Petitioner’s self-reported symptoms; she accepted Petitioner’s reported pain rather than
verifying its sources in her examination. Id. at 94.

Dr. Fedele also addressed the issue of Petitioner’s mental condition, which she conceded
could have explained some of her symptoms such as fatigue. Tr. at 99–100. She acknowledged
that she had not confirmed whether an underlying psychological problem could have contributed
to Mrs. Yalacki’s symptoms, noting that she relied on Petitioner’s denial that she was experiencing
depression or any related condition at the time Dr. Fedele was treating her. Id. at 99. She was,
however, aware of Mrs. Yalacki’s prior treatment for depression and other mental health problems,
and allowed that evidence suggesting prior treaters had associated such underlying health mental
issues with Petitioner’s symptoms was relevant to the CFS diagnosis. Id. at 101–02.

In addition to her testimony (and despite her admitted lack of immunologic expertise), Dr.
Fedele also offered a written letter supporting vaccine causation. See Ex. 17. At trial, however, she
admitted that, although her letter assumed vaccine causation based on the onset of Petitioner’s
symptoms shortly after receiving the Hep B vaccine, she could not establish causality from a
medical or scientific standpoint. Tr. at 83, 92–93, 106–07. In addition, although Dr. Fedele noted
that symptoms experienced by Petitioner before vaccination might be distinguishable from those
she experienced came after, she agreed that the Hep B vaccine could not logically be deemed
causal of any pre-vaccination symptoms. Id. at 108, 109.

3. Dr. Robert Gillespie

Dr. Gillespie was one of the treating cardiologists Petitioner saw in 2014, after she moved
to California. He did not provide a written report, but testified at hearing in support of the
contention that Petitioner was accurately diagnosed with POTS. Tr. at 167–68.

Dr. Gillespie received his B.S. from the University of California-Los Angeles (“UCLA”)
and his M.D. from the University of Chicago, then completed a residency at Loyola University
Medical Center in Maywood, Illinois, followed by a fellowship in cardiovascular medicine at

13
UCLA. Ex. 132 at 1–2, filed Dec. 22, 2017 (ECF No. 80-1). He specializes in cardiovascular
disease, and his practice is based in San Diego, California. Tr. at 165–66. He acknowledged that
he lacks specialized expertise in POTS, although he has diagnosed it and felt that his overall
experience with heart issues made him competent to render an opinion in this case as to its
applicability to Petitioner. Id. at 179.

Dr. Gillespie only saw Mrs. Yalacki on two occasions, both in 2014, and he recalled having
her as a patient. Tr. at 167, 170–71. During the first visit in April 2014, Petitioner informed Dr.
Gillespie that she had previously been diagnosed with POTS. Id. at 169. As he did not possess all
of her prior medical records at the time of this initial visit, Dr. Gillespie attempted to confirm the
diagnosis, and therefore sought to perform a sit-stand test to measure orthostatic hypotension (a
drop in blood pressure) and any heart rate increase when Petitioner stood up (in comparison to
readings obtained while she was seated). Tr. at 169–70; Ex. 12 at 6–7. The orthostatic readings
revealed no substantive change in blood pressure, but Petitioner did display a heart rate increase
of twenty-eight BPM and became symptomatic—that is, she felt so faint upon standing that she
had to lie down. Tr. at 170, 179–80. In Dr. Gillespie’s view, these results were consistent with a
POTS diagnosis, although he allowed that the heart rate increase was just under the thirty BPM
requirement for the diagnosis, and that his records from that visit did not corroborate his
recollection of Petitioner being symptomatic after standing. Id. at 179–80.

Dr. Gillespie next saw Petitioner in May 2014. Tr. at 171. She provided him with her past
medical records at this visit, which he reviewed briefly in in conjunction with his examination of
her. Id. At this visit, Petitioner showed a heart rate increase on standing of only eighteen beats per
minute. Id. at 182; Ex. 12 at 33 (showing heart rate increase from seventy-one BPM when seated
to eighty-eight BPM when standing). Dr. Gillespie nonetheless found this increase sufficient to
seek further testing, so he referred Petitioner to Dr. Noll, an electrophysiologist, for formal
confirmation. Tr. at 172–74, 182. He did not recall, however, whether Petitioner was again
symptomatic after standing, although he surmised she likely was (as the record suggested that he
terminated the sit-stand test prematurely). Id. at 171–72, 180.

On cross examination, Dr. Gillespie was asked about the appropriateness of relying on
orthostatic readings taken from a sit-stand test as opposed to a tilt table test. He acknowledged that
the tilt table test was preferable for diagnosing POTS, but argued nevertheless that a sit-stand test
was an adequate alternative, especially when dealing with a patient like Petitioner, whose
symptoms had previously prevented her from completing her first such test in 2011. Tr. at 178–
79. He also allowed that Petitioner’s medical history allowed for the “understandable concern”
that her post-vaccination symptoms were connected to her pre-vaccination state (and in particular
admitted that deconditioning could exacerbate orthostatic intolerance symptoms), but otherwise
felt it unlikely that anxiety explained Petitioner’s overall condition. Id. at 174, 176. Overall, Dr.

14
Gillespie emphasized that his POTS diagnosis was derived from Petitioner’s actual presentation at
his two visits with her in 2014 (almost three years after vaccination). Id. at 177.

4. Dr. Yehuda Shoenfeld

Dr. Shoenfeld was the sole non-treating medical expert who testified on Petitioner’s behalf
in this case. He offered a theory explaining how the Hep B vaccine could cause POTS and CFS,
as well as an explanation of how the vaccine specifically caused Mrs. Yalacki’s claimed illnesses.

Besides his oral testimony, Dr. Shoenfeld provided a total of five reports on behalf of
Petitioner, modifying his causation theory over time in response to my preliminary determinations
about the theory’s credibility. See generally Ex. 18, filed Dec. 22, 2015 (ECF No. 29-1)
(“Shoenfeld First Rep.”); Ex. 111, filed Mar. 28, 2016 (ECF No. 33-1) (“Shoenfeld Second Rep.”);
Ex. 116, filed Jan. 30, 2017 (ECF No. 53-1); Ex. 117, filed Aug. 31, 2017 (ECF No. 57-1)
(“Shoenfeld Fourth Rep.”); Ex. 127, filed Nov. 29, 2017 (ECF No. 76-1) (“Shoenfeld Fifth
Rep.”).17 In particular, although Dr. Shoenfeld initially proposed a theory he has embraced in other
cases termed “autoimmune/inflammatory syndrome induced by adjuvants” (“ASIA”) to explain
causation, he largely abandoned it in response to my expressed skepticism of its reliability (as
discussed below). Compare Shoenfeld First Rep. at 12–13 (discussing applicability of ASIA
theory to Petitioner’s case) with Shoenfeld Fourth Rep. at 13–14 (explaining theory of causation
based solely on mechanism of molecular mimicry and with no discussion of ASIA).

Dr. Shoenfeld, an internist and clinical immunologist, identifies himself as the head of the
Center for Autoimmune Diseases, which he founded at the Sheba Medical Center in Israel.
Shoenfeld First Rep. at 1; Tr. at 9. He holds the Laura Schwarz–Kipp Chair for Research of
Autoimmune Diseases at Tel Aviv University and has published numerous peer-reviewed articles
and books, primarily in the field of autoimmune and rheumatic diseases. Shoenfeld First Rep. at 1;
Tr. at 9. He serves on the editorial board of thirty-two journals in the field of autoimmunity, and
regularly speaks at conferences centered on autoimmune issues. Shoenfeld First Rep. at 1.18

17
Petitioner also offered a sixth expert report from Dr. Shoenfeld in November 2018, ten months after the conclusion
of the hearing, and three months after both sides had filed post-trial briefs. See Ex. 134, filed Nov. 19, 2018 (ECF No.
97-1). I struck the report from the record because it was (a) untimely, (b) not filed with my permission or at my request,
and (c) was not based on newly-discovered or published literature that could itself not have been filed in a timely
fashion. Order at 2–3, dated Dec. 7, 2018 (ECF No. 101). However, even if I had allowed the report into evidence, it
would not have appreciably aided Petitioner in meeting her burden of proof. The untimely report addresses a single
issue: cross-reactivity between the Hep B vaccine and CFS/POTS based upon possible homology based on a six-
amino acid chain rather than five. Ex. 134 at 1. However, the reliability and plausibility of Petitioner’s causation theory
writ large does not turn on this point in the slightest; for even if accepted as true, it does not make it more likely than
not that any components of the Hep B vaccine could initiate any autoimmune or otherwise aberrant immune response
sufficient to cause CFS or POTS, for the numerous reasons discussed below.
18
On cross-examination, Respondent devoted many questions to undermining Dr. Shoenfeld’s credentials, reported
titles, and research topics and practices. See Tr. at 148–64. For example, Respondent sought Dr. Shoenfeld’s
acknowledgement that he is not actually employed at Sheba Hospital in Tel Aviv (id. at 148–50), that a paper he wrote

15
However, Dr. Shoenfeld does not have specialized expertise in the study or treatment of either
POTS or chronic fatigue, although he did assert that he had published articles on both. Tr. at 9.

At hearing, Dr. Shoenfeld testified about Petitioner’s claimed diagnoses of POTS and CFS,
as well as about possible causal connections between the Hep B vaccine and the two conditions.
Although the opinions he offered differed slightly when discussing each diagnosis, in either case
he opined that the Hep B vaccine could (and in this case did) cause the relevant illness via some
kind of autoimmune process. Dr. Shoenfeld explicitly termed POTS a “classic autoimmune
disease” that could be vaccine-caused. Tr. at 13. CFS, by contrast, only “smell[s] of
autoimmunity,” given the lack of direct scientific support for the position that it is autoimmune,
although he nevertheless proposed it was “probably” autoimmune in origin as well. Id. at 133–35,
208.

Dr. Shoenfeld began his testimony with a discussion of POTS, characterizing it as featuring
a rapidly increased heart rate when a person stands due to a rush of blood to the head. Tr. at 12–
13. He explained further that POTS reflects the working of the autonomic nervous system, which
controls body functions automatically, without will or knowledge on the part of the individual at
issue. Id. at 13. Several different triggers can bring about POTS, including viruses, bacteria, or
vaccines containing adjuvants. Id. at 17–18. The primary diagnostic criteria for POTS, in Dr.
Shoenfeld’s view, is an increased heart rate of at least thirty BPM upon moving from a seated or
recumbent position to standing. Id. at 25. He added, however, that some individuals may
experience a heart rate increase just shy of thirty BPM but still warrant the POTS diagnosis,
especially if the heart rate increase is accompanied by presyncope.19 Id. at 29.

Dr. Shoenfeld also briefly discussed his understanding of the two methods of diagnosing
POTS: the tilt table test and the sit-stand test. Tr. at 25–26. He characterized the tilt table test as

on the ASIA theory’s applicability to the HPV vaccine was later retracted (id. at 162–64), that he appears to serve on
the advisory board of an anti-vaccination group (the group’s website lists him as a board member) (id. at 154–56), and
that the same anti-vaccination group appears to have funded some of his research (id. at 156–62).

These attacks were somewhat successful. Because Dr. Shoenfeld’s medical expertise on immunological matters has
been demonstrated in numerous prior Vaccine Program cases (including cases I have heard personally), evidence of
personal bias or misrepresentations in his CV established by such questioning in this case (which were not established
to be intentional per se) is not enough for me to find him unqualified to testify. Nevertheless, Dr. Shoenfeld’s
combative response to this questioning, coupled with outright evasiveness in responding to certain questions regarding
his background, did reduce his overall credibility as a truthful witness.

In any event, my ultimate decision in this case turns less on Dr. Shoenfeld’s personal credibility and more on the
overall unreliability of the scientific theory he offered when weighed against the strength of Respondent’s expert
evidence. Dr. Shoenfeld is advised, however, to correct any errors in his CV of this nature if he wishes to maintain his
professional credibility as a Vaccine Program expert in future proceedings.
19
Presyncope is a feeling of faintness or lightheadedness. Balance Problems, Mayo Clinic (May 17, 2018),
https://www.mayoclinic.org/diseases-conditions/balance-problems/symptoms-causes/syc-20350474.

16
“elegant,” but deemed the sit-stand test “much more effective” and “more accurate.” Id. at 25–26,
205. In his view, a positive sit-stand test result (revealing a heart rate increase of thirty BPM or
more) would strongly confirm a POTS diagnosis, but a negative result would not rule out a POTS
diagnosis. Id. at 28. He went so far as to disparage the tilt table test, saying, “[w]hat is a tilt test? I
mean, it has a name, and it may impress lay people who are not in the medical field.” Id. at 234.

In Dr. Shoenfeld’s opinion, POTS is an autoimmune disease, a viewpoint he stated is
supported by “several papers.” Tr. at 14–15. Indeed, when questioned as to whether it was always
autoimmune in origin, he proposed that “most if not all POTS . . . cases are autoimmune [in] origin
until proven otherwise.” Id. at 227. Autoimmune disease, he explained, “is a condition in which
the immune system . . . turns toward our own body constituents.” Id. at 11. Such diseases are a
downside to an otherwise evolutionarily advantageous “aggressive immune system,” and he noted
that, as women have more aggressive immune systems than men, autoimmune diseases affect
women at a rate almost ten times higher than they do men. Id. at 11–12. Dr. Shoenfeld explained
that an antibody generated in reaction to a foreign antigen (whether presented by a live virus or
vaccine component) may be identified as pathogenic if it is directed at and affects a “functional
epitope,” or self protein structure in the body, resulting in harm or dysfunction. Id. at 15–16. The
best way to identify a pathogenic autoantibody, in his view, is to inject it into a healthy specimen
to see whether it causes disease, though he also noted that pathogenic autoantibodies can be
identified via in utero transfer from pregnant women to their children. Id. at 16.

Based on review of the record in this case, Dr. Shoenfeld opined that Petitioner in fact
suffered from POTS. Tr. at 57. In support, he referenced the results of her various sit-stand tests,
concluding that her heart rate increase of twenty-eight BPM, though admittedly below the
diagnostic criteria of thirty BPM, was nonetheless indicative of POTS. Id. at 27. This was so even
though some of Mrs. Yalacki’s testing was not completed, since the records (for example, from
Dr. Gillespie’s examination) revealed that testing was halted out of concern that Mrs. Yalacki
might faint. Id. at 51, 54. He also cited POTS diagnoses by three treating cardiologists, the fact
that Petitioner lost consciousness several times in the months following vaccination, and a high
recorded heart rate in a Holter monitor test as a basis for his opinion. Id. at 36–37, 57. By contrast,
he found her initial, negative tilt table test from 2011 to be insignificant, despite the fact that it was
performed closer in time to her receipt of the Hep B vaccine. See id. at 40.

Turning to the question of whether Petitioner’s alleged case of POTS resulted from an
autoimmune process, Dr. Shoenfeld simply (and in a somewhat circular fashion) stated that the
fact that she had the disease was strong evidence of its autoimmune nature. Tr. at 233. Because he
believes that POTS is an autoimmune disease, it follows that it has an autoimmune etiology. Id.
He did, however, cite certain literature filed in this case as supporting his contention that POTS
could be autoimmune. Shoenfeld First Rep. at 8 (citing M. Thieben, et al., Postural Orthostatic
Tachycardia Syndrome: The Mayo Clinic Experience, 82 Mayo Clinic Proc. 308 (2007), filed as

17
Ex. 43, Mar. 31, 2016 (ECF No. 34) (“Thieben”)). Thieben was a retrospective study of 152 POTS
patients seen at the Mayo Clinic over eleven years, and considered the data and test results obtained
during treatment. Thieben hypothesized that a particular autoantibody (the ganglionic
acetylcholine receptor) was associated with neuropathic cases of POTS, although by its own terms
the article does not propose or embrace Dr. Shoenfeld’s contention that POTS is in all cases an
autoimmune disease. Thieben at 308.

Consistent with the above discussion of autoantibodies, Dr. Shoenfeld proposed that the
Hep B vaccine could cause POTS through the mechanism of molecular mimicry. Tr. at 19–20. As
he explained, because of sequential/structural similarities between peptide amino acid sequences
within the viral protein components of vaccines and self protein structures in the human body,
antibodies produced in response to a vaccine might also mistakenly attack the self structures,
thereby turning the antibodies into autoantibodies and causing harm in the form of an autoimmune
disease. Id. at 20. He emphasized the role of the alum adjuvant in vaccines in aiding this process,
as it can drastically increase the production of autoantibodies. Id. at 21.20 In this case, Dr.
Shoenfeld maintained that a particular peptide sequence in the Hep B vaccine—LLLCL—has
homology with “myelin sheets of nerves,” and could therefore result in an autoantibody response
triggered by the vaccine. Id. at 23, 213–18.21 CFS, he later noted, could also be vaccine-caused
through the same mechanism. Id. at 142, 209.

Despite the above, Dr. Shoenfeld acknowledged limitations to his assertions that
Petitioner’s POTS was autoimmune in nature. Thus, he conceded that Mrs. Yalacki was never
tested for the specific autoantibodies known to be associated with POTS. Tr. at 231–32. In
addition, Dr. Shoenfeld maintained that Mrs. Yalacki had undergone plasmapheresis,22 a treatment
directed at autoimmune diseases and which purportedly brought one autoimmune POTS patient
into remission as identified in a scientific study. Id. at 17; Shoenfeld Fifth Rep. at 4 (citing J.
Hendrickson, et al., Complex Regional Pain Syndrome and Dysautonomia in a 14-Year-Old Girl
Responsive to Therapeutic Plasma Exchange, 31 J. Clinical Apheresis 368 (2016), filed as Ex. 128,
Nov. 30, 2017 (ECF No. 77-1)). But he could not point to any medical records establishing that

20
Dr. Shoenfeld did, however, attempt to maintain in so arguing that he was not re-introducing his ASIA theory
through a back door. See Tr. at 122–24.
21
Tangential to his main theory, Dr. Shoenfeld also referenced the condition of small fiber neuropathy—an illness he
acknowledged Petitioner has not been diagnosed with—as nevertheless relevant, given that it purportedly proceeds by
the same molecular mimicry mechanism proposed in this case. Shoenfeld First Rep. at 22; Tr. at 209–11. He did,
however, maintain that it is common for individuals suffering from small fiber neuropathy also to have CFS. Tr. at 212
(discussing M. Martinez-Lavín, Hypothesis: Human Papillomavirus Vaccination Syndrome—Small Fiber Neuropathy
and Dysautonomia Could Be its Underlying Pathogenesis, 34 Clinical Rheumatology 1165 (2015), filed as Ex. 86,
Mar. 31, 2016 (ECF No. 34)).
22
The process of drawing blood, removing the plasma therefrom, and replacing it with another substance, such as
albumin or type-specific fresh frozen plasma. Dorland’s at 1456.

18
Petitioner in fact received plasmapheresis, and I have found in the medical record no evidence that
such treatment occurred. Tr. at 17, 203–04. When faced with the absence of such evidence, Dr.
Shoenfeld again resorted to the same “heads I win, tails you lose” logic that he embraced when
asked about the significance of negative orthostatic testing results in Petitioner’s history, stating
that “[i]f it happened, it supports; if it didn’t happen, it does not exclude.” Id. at 204.

Another deficiency in Dr. Shoenfeld’s contentions concerning the autoimmune character
of POTS was highlighted by his attempt to explain precisely how autoantibodies allegedly
produced in response to the Hep B vaccine would cause POTS. Dr. Shoenfeld pointed to an item
of literature establishing that the gene that codes for norepinephrine transport plays a role “in
regulating the orthostatic reaction,” with the antibodies presumably interfering in some way with
the norepinephrine transporter, affecting its function and resulting in POTS. Tr. at 223, 230
(discussing J. Shannon, et al., Orthostatic Intolerance and Tachycardia Associated with
Norepinephrine-Transporter Deficiency, 342 New England J. Med. 541 (2000), filed as Ex. S, Jan.
17, 2018 (ECF No. 83-1) (“Shannon”)). Shannon compared findings between an individual known
to have orthostatic intolerance and her twin. Shannon at 541. But Dr. Shoenfeld acknowledged
that Shannon does not establish that this same transporter is harmed in the manner alleged, nor
does the article speak about the relevant autoantibodies. Tr. at 223, 225. Indeed, he expressed doubt
that the target of the autoantibody attack could even be identified (id. at 229 (“you can never know
where it might affect”)), and ultimately relied on the reflexive logic of the existence of Petitioner’s
alleged POTS as evidence that the autoimmune process he proposed had in fact occurred. Id. at
221.

Dr. Shoenfeld also maintained that, based upon his review of the medical records,
Petitioner had CFS.23 He began with review of the CDC diagnostic criteria for CFS, noting that
the condition is associated with orthostatic intolerance. Tr. at 129–30. In his view, however, some
criteria (like fatigue) are more significant to the diagnosis than others (such as memory loss). Id.
at 144. He acknowledged as well that depression can overlap with CFS, although he disputed that
the existence of depression is an exclusionary factor, and in fact maintained that a person with
depression would be susceptible to CFS, especially after vaccination. Id. at 116, 117, 131.

In his discussion of CFS, Dr. Shoenfeld conceded that the disease is not widely considered
to be autoimmune, but insisted that it “has an autoimmune flavor.” Tr. at 135. He also admitted
that no pathogenic autoantibodies have been identified in relation to CFS, but argued that it is his
expectation that such autoantibodies will likely be discovered eventually, given CFS’s “association
with other autoimmune diseases,” its “close overlap” with POTS, and the unique prevalence of

23
It is somewhat unclear whether Petitioner maintains that she suffers from both conditions or merely pleads them as
alternative injuries equally supported by the record. In her post-hearing brief, Petitioner states that she suffered from
“CFS and/or POTS.” Pet’r’s Post-Hr’g Br. at 5. Regardless, Dr. Shoenfeld expressed the opinion that both could have
a similar autoimmune character, as well as a similar vaccine-induced origin. Tr. at 142.

19
CFS among women (similar to other autoimmune diseases). Id. at 134–35. He also noted that, as
with other autoimmune diseases, CFS patents can be subject to relapse and remission. Id. at 132.

Part of Dr. Shoenfeld’s testimony involved a chronological review of Mrs. Yalacki’s post-
vaccination medical history, allowing him to point out times and occurrences that he maintained
were consistent with his causation theory. First, looking to early June 2011, he opined that onset
of POTS or CFS did not occur within ninety minutes after vaccination, contrary to Petitioner’s
statements to treaters. Rather, he characterized Petitioner’s state on June 2nd and 3rd as reflective
of a post-vaccination malaise common to any individual who receives a vaccine. Tr. at 117–18
(noting that vaccine package insert anticipates some malaise after vaccination), 120, 124–25.

Not long thereafter, however, Petitioner experienced onset of CFS and/or POTS—although
Dr. Shoenfeld equivocated greatly as to the precise date of onset. Thus, he seemed to identify
June 6, 2011—four days post-vaccination—as the date Petitioner’s CFS began, based on medical
record evidence of a significant worsening of her fatigue that he distinguished from her
immediately-reported reaction. Tr. at 136–37, 141–42, 198. He deemed such a four-day timeframe
medically acceptable, given that this was third Hep B dose Petitioner had received, prompting a
“challenge-rechallenge” effect24 more rapid (in generating antibodies responsive to vaccination)
than an individual would experience if the vaccine were being administered for the first time. Id.
at 59, 60. Subsequently, the medical record revealed ongoing progression of Petitioner’s fatigue
that Dr. Shoenfeld deemed corroborative of her later CFS diagnoses in the following year and
thereafter. Id. at 40, 138, 139.

In some of his prior written reports, however, Dr. Shoenfeld embraced Petitioner’s
immediate malaise reaction (within two hours of vaccination) as a medically acceptable timeframe
for onset of her POTS and/or CFS. Shoenfeld First Rep. at 14; Shoenfeld Fourth Rep. at 13. When
confronted with this discrepancy, Dr. Shoenfeld countered that his understanding of the case had
evolved after closer study. Tr. at 185, 199. At the same time, he maintained that Petitioner’s onset
may have begun within ninety minutes after vaccination (as the records indicate she reported to
treaters), emphasizing that the only important consideration was the fact that onset post-dated
vaccination. Id. at 191 (“[t]he start might have been immediately after the vaccine, the start might
have been several days after the vaccine, the start might have been also several weeks after the
vaccine . . . we cannot know. None of us can know. We can only assume that the vaccine caused
it”), 192, 202 (agreeing with Respondent that “no objective evidence” existed establishing when
Petitioner’s nonspecific vaccine-induced malaise ended and her CFS and/or POTS began).

24
A “challenge-rechallenge” effect occurs “when a patient who had an adverse reaction to a vaccine suffers worsened
symptoms from an additional injection of the vaccine.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317,
1322 (Fed. Cir. 2006). In this case, of course, the eleven-year gap between when Mrs. Yalacki last received the Hep
B vaccine and her June 2011 dose is simply too long to give consideration to this argument (which Dr. Shoenfeld
otherwise did not linger on in his testimony).

20
With regard to onset of Petitioner’s POTS, Dr. Shoenfeld stressed that evidence of
dizziness was more probative than fatigue (although because CFS and POTS had some
symptomatic overlap, fatigue could be a POTS symptom). Tr. at 190, 194. However, he was
reluctant to attribute reports of dizziness the day after vaccination as onset of Petitioner’s POTS.
Id. at 194–96. Rather, Dr. Shoenfeld seemed more comfortable referencing symptoms that
Petitioner displayed a little more than one month later (beginning July 8, 2011) as “classically”
proof of orthostatic intolerance, with a fainting incident reported by Mrs. Yalacki to treaters on
July 28, 2011 as further evidence of her POTS. Id. at 32–33. In August and September of that year,
Petitioner’s orthostatic problems became even more evident, and were subsequently confirmed by
heart rate monitor testing. Id. at 34–36, 38–39 (deeming significant Dr. Abruzzo’s statement from
September 2011 that Petitioner might have an “autonomic neuropathy”).25

Dr. Shoenfeld disputed the existence of reasonable alternative explanations for Petitioner’s
symptoms. He noted that treaters had early on excluded the possibility of a viral infection, ongoing
inflammation, or some similar cause for her reaction and fatigue. Tr. at 126–28. However, he was
more conclusory when discussing Petitioner’s overall history, including the ample evidence of
Petitioner’s preexisting symptoms, which included not only fatigue but considerable mental health
issues that could have related to her post-vaccination condition. See, e.g., id. at 38–39 (“[t]here is
only one time, I believe, that in that file [Petitioner’s medical record] the word ‘tired’ was
mentioned before the hepatitis B”), 140 (maintaining that there is “no comparison” between
Petitioner’s pre- and post-vaccination symptoms relevant to her purported CFS or POTS
diagnoses).

B. Respondent’s Witnesses

1. Dr. Philip Low

Dr. Low filed two reports in this case and also testified at hearing. See Ex. H, filed June
30, 2016 (ECF No. 42-7); Ex. N, filed Oct. 16, 2017 (ECF No. 64-6). Dr. Low offered the opinion
that Mrs. Yalacki suffers from “severe debilitating deconditioning,” and that any associated mild
orthostatic intolerance she has experienced was solely the product of that deconditioning (which
in turn stemmed from her demonstrated anxiety). Tr. at 259, 299.

As noted in his curriculum vitae (“CV”), Dr. Low received his medical and research
doctorate degrees from the University of Sydney in Australia. Ex. I at 1, filed June 30, 2016, ECF
No. 43-7 (“Low CV”); Tr. at 249. He completed a fellowship in internal medicine with the Royal
Australian College of Physicians, as well as a neurology residency at the Mayo Clinic in Rochester,

25
Dr. Shoenfeld also attempted to diminish record proof that undermined or contradicted a POTS diagnosis. Thus,
when asked about determinations in February 2013 by Dr. Rollins that Petitioner did not likely have POTS given the
orthostatic readings she obtained, Dr. Shoenfeld demurred, arguing (as before in his testimony) that while positive
results confirmed his preferred diagnosis, negative tests did not necessarily exclude it. Tr. at 207–08.

21
Minnesota. Low CV at 1–2. Currently, Dr. Low serves as a Professor of Neurology at the Mayo
Clinic Medical School. Id. at 3. During his time at Mayo, Dr. Low has served in various
departmental and academic capacities, including as Director of the Neuroscience Laboratory,
Director of the Autonomic Reflex Laboratory (which he founded), and Chairman of the Division
of Clinical Neurophysiology. Low CV at 3–4; Tr. at 254. Dr. Low has co-authored over four
hundred items of literature in the field of autoimmunity, including many articles on POTS,
antibody-mediated autoimmune neuropathy, and orthostatic intolerance. Low CV at 9–50; Tr.
at 258. Indeed, he is a senior author or author in roughly half of the articles on POTS referenced
in Dr. Shoenfeld’s reports and filed by Petitioner. Tr. at 271. He has served on the editorial boards
of multiple journals centered on autonomic and nervous system research. Low CV at 4.

Over the past forty years, Dr. Low’s time has been divided evenly between patient practice
and research. Tr. at 255–56. During his clinical practice, which is focused on autonomic disorders,
Dr. Low estimates that he sees twenty to thirty patients per week. Id. at 256. He has treated many
patients with POTS, small fiber neuropathy, orthostatic intolerance, CFS, autoimmune disorders,
and autoimmune neuropathies. Id. at 256–57.

At hearing, Dr. Low provided extensive background information on the autonomic nervous
system. As he explained, the autonomic system controls the heart rate and blood pressure,
stabilizing both without conscious effort as people move between different postures and positions.
Tr. at 260. He defined terms relevant to autonomic nervous system dysfunction, including
autonomic neuropathy (“neuropathy due to structural damage of autonomic fibers,” with many
apparent and readily-identified symptoms). Id. at 261. Tests exist to assess possible damage to the
autonomic system, which Dr. Low himself has helped to develop. Id. at 264. He was dismissive of
the term dysautonomia, however, calling it an “almost useless term” that is frequently employed
as a catch-all when a treater “can’t think of something better” to precisely explain the source of an
orthostatic problem. Id. at 261.

Orthostatic intolerance, Dr. Low explained, is an umbrella term for conditions in which
“when you stand up, you feel bad, and if you sit down or lay down, you no longer feel bad.” Tr.
at 262–63. He distinguished between three subcategories of orthostatic intolerance: orthostatic
hypotension, in which an individual’s blood pressure drops when she stands up, unaccompanied
by a significant change in heart rate; POTS, in which the heart rate increases but blood pressure
remains unchanged when an individual stands up; and syncope, in which both the heart rate and
blood pressure undergo a delayed and sudden drop, often leading to fainting. Id. at 263. POTS, Dr.
Low stated, is not usually caused by damage to the autonomic nervous system. Id. at 270. CFS can
be associated with POTS, he noted, though the existence of chronic fatigue is not integral to a
POTS diagnosis. Id.

22
Dr. Low also provided a detailed explanation of deconditioning and its relationship to
orthostatic intolerance and POTS. He deemed it very common for POTS (and other forms of
orthostatic intolerance) to be the result of physical deconditioning,26 whether due to inactivity or
environmental demands. Tr. at 280–81. He described a study of his own, in which he found that
ninety percent of a set of POTS patients had “laboratory-proven” deconditioning. Id.; see also A.
Parsaik, et al., Deconditioning in Patients with Orthostatic Intolerance, 79 Neurology 1435 (2012),
filed as Ex. H Tab 7, June 30, 2016 (ECF No. 43-2) (Dr. Low as co-author). He also referenced
studies involving astronauts upon their return to earth as confirming the effects of the
deconditioning they experienced after spending long amounts of time in space. Tr. at 281.
Accordingly, in Dr. Low’s view, deconditioning can cause POTS (although it more commonly
leads to a “lesser degree” of orthostatic tachycardia). Id. at 281–82. He estimated that the negative
effects of deconditioning could manifest after just two weeks of physical inactivity. Id. at 282.

Dr. Low emphatically contested Dr. Shoenfeld’s view that POTS is predominantly
autoimmune in nature, supporting his position with experiences from his own research at Mayo.
Tr. at 271. Dr. Low agreed that there does exist a form of autonomic neuropathy involving a single
type of ganglionopathy-associated autoantibody, and that Thieben had observed that six of forty-
two studied subjects (or approximately fourteen percent) tested positive for this antibody. Id. at
271–72; Thieben at 311, 313. This kind of neuropathy involves structural damage to the autonomic
nervous system, resulting in POTS-like symptoms as well as many other symptoms not present in
this case (or in most POTS cases for that matter). Tr. at 272, 303–04 (listing loss of blood pressure
control, loss of bladder control, loss of ability to breathe, and tissue injury as other clinical indicia
of existence of autoimmune-mediated autonomic neuropathy). It would also be characterized by
high levels of the relevant autoantibody. Id. at 272.

But Dr. Low indicated that his own extensive research into POTS and the autonomic
nervous system had led him to question the prevalence of autoimmune-caused autonomic
neuropathy. As he explained, his study and treatment of POTS patients had generally revealed
“multiple antibodies at low titers.” Tr. at 272. In addition, Dr. Low noted that since Thieben’s
publication over ten years ago, researchers at Mayo had looked more closely into the correlation
between the autoantibodies it first observed and POTS but found “zero relationship of titer to
autoimmune failure.” Id. As a result, Dr. Low today does not routinely test POTS patients for
particular autoantibodies, “because we have not been able to demonstrate any causative antibody.”
Id. at 274. He also added that, unlike diseases widely understood to be autoimmune (for example,
Guillain-Barré syndrome), POTS cannot be effectively treated with immunosupressants or other
immune-mediating therapies like plasmapheresis. Id. at 274–75.

26
Deconditioning is “a change in cardiovascular function after prolonged periods of weightlessness.” Dorland’s
at 475.

23
There are certain clinical procedures widely recognized as appropriate for diagnosing
POTS. Tr. at 264–66. Contrary to Dr. Shoenfeld, Dr. Low opined that the tilt table test is “essential
for the diagnosis of POTS,” and that a consensus view exists in the medical community that this
is the case. Id. at 265, 297–98, 307. He deemed the sit-stand test, by contrast, “totally inadequate”
to make a formal diagnosis of POTS, although he allowed that it was a reasonable tool for treaters
to use in assessing if a potential POTS diagnosis was worthy of further investigation. Id. at 305–
06. The sit-stand test is unstandardized, and necessarily requires a patient to contract her muscles
(thereby affecting the heart rate reading), which the tilt table test largely avoids. Id. at 266–67,
305. He conceded that the tilt table test is not perfect, however, and that more accurate results
could be obtained by performing a “parachute tilt,” which entails the use of a harness. Id. at 267.
He also noted that a Holter monitor is not a useful diagnostic for POTS, as it simply measures
heart rate over time and does not discount the natural surges in heart rate that many people
experience intermittently, especially when they suffer from anxiety. Id. at 270. Besides the tilt
table test, Dr. Low routinely measures autonomic function to test for POTS, and also measures
plasma norepinephrine levels in the patient’s blood, both while sitting and standing. Id. at 269,
296–70.

Dr. Low reiterated that a measured heart rate increase of at least thirty BPM in a
standardized tilt table test is a critical diagnostic feature of POTS. Tr. at 301. He added, however,
that this is a “very low bar,” and that in addition to the sharp increase in heart rate, a POTS patient
would typically present with a high absolute heart rate as well—typically above 120 BPM. Id.
at 302. This type of heart rate increase and high absolute heart rate would be consistent over
multiple readings for a POTS patient, he noted. Id. at 301.

Based on the above, his own personal knowledge, and his review of the medical records,
Dr. Low opined that Petitioner did not likely have POTS in 2011 or 2012. Tr. at 283. Her tilt table
test (performed in September 2011) lasted for thirteen minutes, longer than the standard ten, but
her heart rate increased by only ten BPM. Id. (discussing Ex. 5 at 84). Records from that same visit
also did not reflect other symptoms of orthostatic intolerance essential for a POTS diagnosis. Id.
at 283–84. Otherwise, throughout Petitioner’s medical records over the relevant time period, there
were “too many normal type recordings” of her heart rate to substantiate a POTS diagnosis. Id.
at 301. In addition, and although not measured until 2013, Mrs. Yalacki’s plasma norepinephrine
levels also tested at normal levels. Id. at 278. At most, she experienced intermittent mild orthostatic
intolerance attributable to deconditioning. Id. at 293–94, 301. He also noted that the many heart
rate increase readings seen in the medical record and cited to as proof of POTS could equally be
attributed to Petitioner’s demonstrated long-standing anxiety. Id. at 296.

To substantiate his conclusions, Dr. Low highlighted numerous aspects of Petitioner’s
medical record. In the years before receiving the Hep B vaccine, Petitioner showed signs of an
overactive sympathetic nervous system (dizziness, nausea, etc.) on several occasions, indicating

24
possible anxiety. Tr. at 279–80 (discussing Ex. 1 at 9, 70 (June and October 2008 records)). He
deemed it common in “patients who have significant deconditioning” to display such symptoms.
Id. at 280. Dr. Low went on to characterize Petitioner’s post-vaccination symptoms beginning June
2011 as a continuation of such prior symptoms. Id. And he took particular note of some of the
neurologic evaluations Petitioner received in 2012 and 2013. Thus, Dr. Seibert deemed it unlikely
in November 2012 that Mrs. Yalacki was suffering from “autonomic dysreflexia” (which Dr. Low
characterized as featuring “storms” in which the autonomic nervous system “goes crazy”). Id. at
293 (discussing Ex. 2 at 537). Dr. Rollins similarly doubted that the existing test results and record
at the time (winter 2013) supported a POTS diagnosis. Tr. at 293 (discussing Ex. 2 at 636).

Dr. Low also reviewed some of the cardiologic exams and associated orthostatic testing
Petitioner underwent in the years after her receipt of the Hep B vaccine, concluding from these
records that there was not strong evidence supporting a POTS diagnosis. For example, he noted
that during Petitioner’s visits to Dr. Betkowski in March 2013 (almost two years after receiving
the Hep B vaccine), testing revealed a blood pressure drop on the sit-stand test—a determination
inconsistent with a POTS diagnosis, even if Petitioner’s heart rate did increase (which could, in
Dr. Low’s view, simply reveal a “healthy heart”). Tr. at 268–69, 286 (discussing Ex. 2 at 667). He
was similarly dismissive of the orthostatic readings obtained at an April 2013 visit with Dr.
Betkowski, noting that while tests revealed a “generous heart rate response,” they similarly showed
a drop in blood pressure that would not be consistent with POTS. Id. at 286–87 (discussing Ex. 2
at 702).

Dr. Gillespie’s examinations of Petitioner in 2014 (which, as noted above, Dr. Gillespie
discussed at hearing) were no more persuasive to Dr. Low of the accuracy of the POTS diagnosis.
He characterized the heart rate increase that Dr. Gillespie measured via a sit-stand test during
Petitioner’s April 2014 exam (from seventy-one to eighty-eight BPM) as “unimpressive,” and
otherwise “very typical of the changes one sees with deconditioning.” Tr. at 288–89 (discussing
Ex. 12 at 6). Indeed, the fact that Petitioner had been able to stand for a lengthy period of time
during this exam to remeasure her standing blood pressure was evidence that she was in fact
“orthostatically tolerant” as of that time. Id. at 288. Dr. Gillespie’s findings at Petitioner’s May
2014 visit were also in Dr. Low’s view unsupportive of a POTS diagnosis, as she experienced a
fairly normal heart rate increase. Id. at 298 (discussing Ex. 12 at 33–34). And at another treater’s
visit in July 2014, Petitioner displayed a modest standing absolute heart rate of 106 BPM, which
Dr. Low deemed insufficient to suggest POTS. Id. at 290 (discussing Ex. 15 at 203). At best, the
heart rate increase Petitioner displayed at this time indicated the need for a repeat of the negative
tilt table test she had received in 2011. Id. at 290–91.

Besides noting the deficiencies in the medical record for a POTS diagnosis, Dr. Low
testified that he saw no evidence in that same record supporting the conclusion that Petitioner
suffered from an autoimmune-mediated autonomic neuropathy that could have caused her POTS

25
symptoms. The medical record, he opined, did not suggest that Mrs. Yalacki had ever suffered any
injury to autonomic structures, nor did she display the secondary symptoms (in addition to
orthostatic intolerance suggestive of POTS) that would reveal the existence of such damage, such
as loss of bladder control or breathing difficulties. Tr. at 294. There is also no evidence in the
record that Petitioner tested positive for the autoantibody discussed in Thieben (and although
Petitioner may not have undergone such testing, Dr. Low suggested that this was likely due to the
fact that treaters saw no need to do so). Id. at 295.

Finally, Dr. Low addressed some specific components of Petitioner’s causation theory. In
his understanding of Dr. Shoenfeld’s testimony, Dr. Shoenfeld had proposed that an “adrenergic
antibody,” presumably produced in response to the Hep B vaccine, was the most likely mechanistic
causal element in triggering POTS. Tr. at 272. But literature offered to support this contention did
not involve an actual measurement of the antibody in question in humans. Id. (discussing H. Li, et
al., Autoimmune Basis for Postural Tachycardia Syndrome, J. Am. Heart Ass’n 1 (2014), filed as
Ex. 58, Mar. 31, 2016 (ECF No. 34) (“Li”)). Rather, the Li study evaluated the effect of an injection
of blood serum from fourteen POTS patients into animals on arteriole contractibility, concluding
that POTS could have an autoimmune pathology. Tr. at 272–73; Li at 9. Dr. Low did not accept
this finding, however, interpreting Li to be observing merely “a secondary phenomenon that occurs
in people who have sympathetic activity, either because of the disease, or because of treatment,”
not that the antibody itself was associated with causing POTS. Tr. at 273–74.

Dr. Low also criticized Dr. Shoenfeld’s reliance on Shannon, which, as noted above,
looked at the norepinephrine transporter responsible for uptake and management of adrenaline in
the blood based on a single-patient evaluation, and which Dr. Shoenfeld argued was evidence of a
plausible antigenic target for his theorized autoimmune attack. Tr. at 275–76 (discussing generally
Shannon). Normally, when a person stands, the sympathetic nerve is activated, causing the release
of norepinephrine (a kind of adrenaline specific to blood vessels), with some norepinephrine
interacting with a receptor while the rest is taken back up by the transporter. Id. at 276. Shannon
considered a single individual who experienced dysfunction of the transporter (likely due to
genetic mutation) in comparison to her healthy twin, concluding that the excess norepinephrine
that was not taken back up due to transporter failure resulted in tachycardia. Id. (discussing
Shannon at 542–44). But Dr. Low questioned the significance of Shannon, noting first that it
involved a single individual, and second that Mrs. Yalacki’s own blood norepinephrine levels were
tested in March 2013 and found to be normal, rendering Shannon’s findings immaterial. Tr. at
276–77 (discussing Ex. 3 at 7), 278 (characterizing the norepinephrine amounts measured in
Petitioner as “not the value you would expect in someone with norepinephrine transporter
blockage”).

26
2. Dr. Peter Donofrio

Peter Donofrio, M.D., provided two written reports on Respondent’s behalf and testified at
hearing. See Ex. A, filed July 27, 2015 (ECF No. 25-1); Ex. O, filed Oct. 16, 2017 (ECF No. 64-
9). Dr. Donofrio offered the opinion that Mrs. Yalacki did not have CFS, and that any post-
vaccination symptoms she did experience were most likely attributable to her prior documented
mental health problems and anxiety.

As reflected in his CV, Dr. Donofrio received his B.S. at the University of Notre Dame in
Indiana, followed by his M.D. at Ohio State University in Columbus. Ex. B at 1, filed July 27,
2015 (ECF No. 25-8) (“Donofrio CV”). He completed a three-year internal medicine residency at
Good Samaritan Hospital in Cincinnati, Ohio, followed by a three-year neurology residency at the
University of Michigan. Id. at 2. He also completed a neuromuscular fellowship at the University
of Michigan. Id. Dr. Donofrio holds board certifications in neurology, nerve conduction studies,
electromyography, and neuromuscular disorders. Tr. at 309. He currently serves as a professor of
neurology at Vanderbilt University School of Medicine in Nashville, Tennessee, and previously
worked as a professor of neurology at Wake Forest University and the University of Michigan.
Donofrio CV at 2–3. In addition to his teaching and research as a professor, he has a clinical
practice as well that takes up half of his time, seeing thirty to forty patients per week with a wide
variety of neurologic illnesses, including peripheral neuropathies, myasthenia gravis, and CFS. Tr.
at 310, 311, 314. He acknowledged, however, that he only encounters CFS a handful of times per
year. Id. at 339.

Dr. Donofrio began his testimony with a discussion of CFS. In his experience, CFS is
reasonably considered as a possible explanation for generalized symptoms of weakness and fatigue
that cannot otherwise be attributed to an identifiable neurologic or muscular problem. Tr. at 314.
Dr. Donofrio disputed that CFS has an autoimmune basis, however, maintaining that (a) no
autoantibody had ever been identified as associated with CFS, and (b) nothing was yet understood
about the “passive physiology” of the condition’s course (meaning how an autoantibody would
interfere with some body process to cause CFS from a pathological perspective). Id. at 332–33.

In analyzing whether Petitioner’s history suggested CFS as a proper diagnosis, Dr.
Donofrio discussed and elaborated upon the same CDC criteria27 reviewed by Dr. Fedele when
she diagnosed Petitioner, adding that their application also required consideration of a patient’s

27
Dr. Donofrio also briefly addressed the proposed CFS criteria articulated by the Institute of Medicine (the “IOM”),
which were released in 2015 and somewhat narrow the relevant criteria, focusing on two (post-exertional malaise and
unrefreshing sleep) over other CFS factors listed in the CDC criteria, and adding additional symptoms to the list of
relevant criteria. Tr. at 329–30 (discussing Ex. A Tab 1, filed July 27, 2015 (ECF No. 25-2)). Dr. Donofrio’s testimony
focused far more on the CDC criteria, and he opined that the IOM criteria are easier to meet, although he said he did
not discount them altogether simply for that reason. Id. at 335.

27
medical history, a physical and mental health status exam, and lab tests. Tr. at 314–15. He
emphasized that these criteria require a new onset of unexplained, persistent or relapsing fatigue
that cannot be attributed to exertion, is not alleviated by rest, and which produces deficits in the
patient’s ability to engage in her life and occupation. Id. at 315 (discussing Ex. 125 at 1). He also
underscored that included as an exclusionary criterion is evidence of “any past or current diagnosis
of major depressive disorder.” Id. at 316–17 (quoting Ex. 125 at 1).

Based upon the above, Dr. Donofrio reviewed Petitioner’s medical record at hearing in an
effort to demonstrate the basis for his opinion that she could not properly be diagnosed with CFS.
He readily admitted that the records displayed many instances in which Petitioner reported
debilitating fatigue. Tr. at 317. He questioned, however, whether any “impairment of memory”
was evident in the medical record, especially since Petitioner was very proactive in seeking
treatment and was otherwise never tested for mental deficits (procedures Dr. Donofrio deemed
easy to perform) when her fatigue was evaluated by treaters. Id. at 317–19. He also noted a lack
of evidence that Petitioner had a sore throat or swollen lymph nodes. Id. at 319. And he opined
that there was a lack of medical record evidence that Petitioner was experiencing unrefreshing
sleep. Id. at 323–24, 331. Dr. Donofrio distinguished this from mere fatigue or experiencing a
“bad” sleep occasionally, adding that differentiating fatigue from persistent unrefreshing sleep
would require careful treater inquiry. Id. at 324.

Dr. Donofrio took particular exception to the conclusion that Mrs. Yalacki demonstrated
muscle pain, noting that there was ample pre-vaccination evidence of similar symptoms that also
predated her 2011 claims of fatigue, reviewing medical records from as far back as 2008 and 2009
to support this contention. Tr. at 319–22 (discussing Ex. 1 at 56, 80, 125, 127). When asked on
cross-examination about the relevance of evidence of symptoms so long before vaccination, he
responded that the CDC criteria provide that such evidence bore on whether the aches or pain were
in fact new, and thus would be proper to consider. Id. at 334–35 (discussing Ex. 125 at 1 (CDC
criteria requires that muscle pain did not predate onset of fatigue in order to constitute a symptom
of CFS)).

Dr. Donofrio also placed emphasis on one particular exclusionary criterion: the existence
of a depressive disorder or other mental health condition. Tr. at 325.28 Thus, he observed that

28
After Respondent inquired of Dr. Donofrio’s credentials and expertise, Petitioner’s counsel objected to Dr. Donofrio
being deemed or qualified as an expert on psychiatric matters, solely based on his neurologic training and background.
Tr. at 312. I noted the reasonableness of the objection, and do not give great weight to testimony by Dr. Donofrio
intending to offer a mental health diagnosis of Mrs. Yalacki. Id. at 312–13. However, because preexisting mental
health issues bear on the appropriateness of a CFS diagnosis, and because Petitioner’s record is replete with references
to a variety of mental health problems, many of which predated vaccination, I give some consideration to such
evidence, and whether (as a treater familiar with CFS) a practitioner like Dr. Donofrio would take such matters into
account. See id. at 325 (Dr. Donofrio confirming a mental health diagnosis was not part of his opinion, even though
he considered record evidence of Petitioner’s reported mental health status in reaching his opinion as to the
appropriateness of a CFS diagnosis).

28
records from before vaccination (and even the same month thereof) to more than one year after
mentioned Petitioner’s long-standing struggles with depression and anxiety. Id. at 325–26
(discussing Ex. 2 at 550 (November 2012 record)), 326–27 (discussing Ex. 1 at 327 (September
2010 record)), 327–28 (discussing Ex. 2 at 123–24 (June 30, 2011 record where treater “strongly
recommended” depression treatment, which Petitioner refused)). He deemed the June 2011 record
especially significant, as it reflected the fact that within a month of vaccination Petitioner was
aware of the possibility that the actual source of her symptoms had nothing to do with the Hep B
vaccine. Id. at 328–29.

The fact that Petitioner also experienced intermittent improvement, as reflected in her
medical history, was further evidence to Dr. Donofrio that the CFS diagnosis was inaccurate. His
read of the medical records suggested that Mrs. Yalacki was not experiencing fatigue or other such
symptoms for approximately six months, from March until September 2012. Tr. at 331. In Dr.
Donofrio’s experience, it was unheard of for patients with CFS to experience “spontaneous six-
month remissions.” Id. at 331, 338. He did, however, admit that the severity of CFS symptoms
could wax and wane from day to day, although an intercurrent infection (a URI, for example)
might also make it mistakenly appear to an individual that her CFS had worsened. Id. at 332, 337–
38.29

3. Dr. J. Lindsay Whitton

Dr. Whitton, an immunologist, was Respondent’s third expert, offering two written reports
in addition to his hearing testimony. See Ex. E, filed June 30, 2016 (ECF No. 38-1); Ex. M, filed
Oct. 16, 2017 (ECF No. 64-1). He opined that Dr. Shoenfeld’s view that the Hep B could cause
CFS or POTS was scientifically unreliable. Tr. at 351.

As shown in his CV, Dr. Whitton received his medical degree, as well as a Ph.D. in
molecular biology, from the University of Glasgow in Scotland. Ex. G at 1, filed June 30, 2016
(ECF No. 42-6) (“Whitton CV”). He currently works as a professor at Scripps Research Institute
in La Jolla, California, where he both teaches and does research on the topics of virology and
immunology. Id.; Tr. at 343–44. His research focuses on immunologic responses to viruses,
making him very familiar with the innate and adaptive immune systems. Tr. at 347–48, 350. He
serves on the editorial board of several reputable medical journals. Whitton CV at 1–2. Although
not licensed as a medical doctor in the United States, Dr. Whitton maintained that the education
and training he had received abroad was sufficient to meet those standards had he sought licensure.
Tr. at 345–46.

29
On cross examination, Dr. Donofrio allowed that such an intercurrent infection would constitute an “immune
challenge,” raising the possibility (to the extent that a person’s existing CFS was worsened by the infection) that CFS
itself is immune-mediated. Tr. at 335–36. However, Dr. Donofrio emphasized that the impact of such an infection
would be felt by any person independent of their preexisting CFS. Id. at 336.

29
Dr. Whitton initially provided a series of definitions relevant to his opinion. He defined
“antigen” as something (usually a protein) that triggers an adaptive immune response, whether in
the form of the production of antibodies or a T cell response. Tr. at 353. Proteins are made up of
chain of amino acids, of which there total twenty standard to the human body. Id. at 353–54. A
chain of amino acids is called a peptide, and molecular mimicry can occur when a peptide in an
antigenic protein shares “homology,” or identity, with a self protein in the body, making both look
the same to any immune response (antibodies or T cells) generated in reaction to the antigen. Id.
at 355. Autoimmune disease will occur if that immune response mistakenly attacks the self protein
or structure. Id. Dr. Whitton added that the term “molecular mimicry” applies only cases actually
resulting in disease, and cautioned that it is incorrect to assume that homology between antigen
components and a self protein will invariably result in harm. Id.

With the above as backdrop, Dr. Whitton turned to Petitioner’s invocation of molecular
mimicry as a mechanism by which the Hep B vaccine could cause an autoimmune response of
some kind resulting in disease. He characterized Dr. Shoenfeld’s argument as holding that a surface
antigen of the vaccine included an amino acid peptide sequence that had homology with
components of the norepinephrine transporter, and that the unusual nature of this homology
resulted in a cross-attack by antibodies produced in response to the vaccine and causing autonomic
dysfunction sufficient to result in CFS or POTS. Tr. at 352. He noted that Dr. Shoenfeld proposed
a pentamer, or five amino acid chain sequence, was sufficient for homology to exist—but in Dr.
Whitton’s view, homology on that scale was wide-spread in the human body, and thus not rare at
all. Id. at 356–58.

In support of this view, he referenced literature confirming that homology was
“commonplace,” and the reasonable result of the fact that human proteins were comprised of a
finite set of amino acids. Tr. at 362–64 (discussing A. Silvanovich, et al., The Value of Short Amino
Acid Sequence Matches for Prediction of Protein Allergenicity, 90 Toxicological Sciences 252
(2006), filed as Ex. E Tab 5, June 30, 2016 (ECF No. 38-6)). In fact, Dr. Whitton noted, if a mere
match between a five-amino acid peptide component of an antigen and a self protein component
were enough to result in molecular mimicry, “we would be dead” from all the autoimmune cross-
reactivity that would result. Id. at 366, 377. Dr. Whitton therefore maintained that the homologous
sequences identified by Dr. Shoenfeld were “cherry picked for this case,” and amounted to
selection bias rather than verified and reliable scientific evidence of a pathologic cross-reaction
spurred by molecular mimicry. Id. at 361.

Dr. Whitton next attacked the bases for Petitioner’s argument that the norepinephrine
transporter is the target antigen for the alleged autoimmune cross-reactive process. Tr. at 366–67.
He opined that Petitioner’s normal plasma norepinephrine test result from 2013 reflected that she
does not have a defect in that protein. Id. at 367. Further, with regard to Petitioner’s argument

30
about homology between the Hep B vaccine and a specific target antigen, Dr. Whitton argued that
Petitioner had mistakenly referenced homologous epitopes from the Hep C rather than Hep B virus,
and that those that were derived from the Hep B virus were actually limited to a single homologous
epitope. Id. at 371–72. And he proposed that the homologous self-epitopes in question are not
“antibody epitopes” that would (mistakenly) recognize antibodies produced in response to the
vaccine, but T cell epitopes, meaning that they were inconsistent with Dr. Shoenfeld’s entire
theory. Id. at 373.

Dr. Whitton also spoke to the purported timeframe in which Petitioner alleges to have
experienced a vaccine reaction. Although he allowed that certain severe and immediate reactions
by the adaptive immune system to vaccination are possible in a short timeframe (for example,
anaphylaxis), he disputed that the record in this case revealed such a clear reaction. Tr. at 378. He
more definitively rejected the notion that Petitioner’s onset occurred within two hours of
vaccination, noting that even Dr. Shoenfeld allowed for the fact that post-vaccine “malaise” might
last for up to twenty-four hours. Id. at 379. In his understanding, the best models for how molecular
mimicry leads to autoimmune cross-reactions have shown that it can take six to ten days for the
antibody upregulation to occur, far longer than the short timeframes argued for by Petitioner. Id.
at 379–81. He added that he would also expect some evidence of nonspecific indicators of an
autoimmune process (such as proof of ongoing inflammation) to exist if Petitioner’s timeframe for
onset were accurate, although he admitted that such speculation on his part went beyond his
expertise in this case as an immunologist and virologist. Id. at 390.

In addition to offering an opinion specific to components of Petitioner’s causation theory,
Dr. Whitton commented on the persuasiveness of that theory in light of the evidence offered in its
support. He maintained that Petitioner had not offered broadly reliable evidence associating the
Hep B vaccine with POTS or CFS. Tr. at 382. When challenged by Petitioner to enumerate what
such evidence would look like, Dr. Whitton responded that he would need to see proof of (a) the
relevant autoantibody, (b) evidence of Mrs. Yalacki’s norepinephrine transporter protein
dysfunction, or (c) some kind of experimental study or model establishing that the Hep B vaccine
had been associated with the injuries alleged. Id. at 383–85. He also attacked Dr. Shoenfeld’s
questioning the possibility that an unidentified wild virus could have caused Petitioner’s POTS or
CFS, noting that in his view a viral infection was generally more likely to trigger disease or an
aberrant immune response than a vaccine. Id. at 387–89.

III. Procedural History

As noted above, this case was initiated in April 2014. Petitioner subsequently filed relevant
medical records, concluding the process on August 6, 2014, with the Statement of Completion

31
(ECF No. 13). Respondent’s Rule 4(c) Report was thereafter filed on October 6th (ECF No. 14),
in which Respondent challenged the appropriateness of an entitlement award.

Petitioner filed Dr. Shoenfeld’s first expert report on December 22, 2015. Noting that Dr.
Shoenfeld relied on his ASIA theory to explain vaccine causation in her case, I stated during a
status conference that other special masters have repeatedly found this theory to be unpersuasive
and scientifically unreliable. See Order, dated Jan. 5, 2016 (ECF No. 30).30 After Petitioner filed
an additional report from Dr. Shoenfeld that largely reiterated his prior statements invoking ASIA,
I again expressed my concerns to Petitioner that reliance on this theory would be inadvisable. See
Order, dated July 19, 2016 (ECF No. 47).

Petitioner subsequently filed additional expert reports from Dr. Shoenfeld that did not raise
ASIA and supporting medical literature, as well as a written evaluation from Jack Kleid, M.D.31
Respondent filed reports and literature from Drs. Low, Donofrio, and Whitton. Petitioner amended
her claim on August 31, 2017, the same day she filed her prehearing brief, arguing in the alternative
in both documents that the Hep B vaccine significantly aggravated a preexisting condition. See
Am. Pet. at 2, filed Aug. 31, 2017 (ECF No. 56); Pet’r’s Pre-Hr’g Br. at 7–14, filed Aug. 31, 2017
(ECF No. 58). Respondent submitted his prehearing brief in October of 2017, and a two-day
entitlement hearing took place on January 22–23, 2018. The parties submitted post-hearing briefs
on August 20, 2018. This case is now ripe for decision.

IV. Applicable Legal Standards

A. Claimant’s 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 and also occurring within a statutorily-prescribed period of

30
In my Order, I directed Petitioner’s attention to the following Vaccine Program cases in which special masters did
not accept the ASIA theory as a scientifically-reliable explanation for vaccine-caused injuries: Rowan v. Sec’y of
Health & Human Servs., No. 10-272V, 2014 WL 7465661 (Fed. Cl. Spec. Mstr. Dec. 8, 2014), mot. for review denied,
2015 WL 3562409 (Fed. Cl. June 9, 2015); D’Angiolini v. Sec’y of Health & Human Servs., No. 99-578V, 2014 WL
1678145 (Fed. Cl. Spec. Mstr. Mar. 27, 2014), mot. for review denied, 122 Fed. Cl. 86 (2015).
31
Although Dr. Kleid’s CV was not filed in this case, his report indicates that he works as an associate professor of
cardiology at the University of California San Diego. Ex. 115 at 15, filed Nov. 17, 2016 (ECF No. 50-1). Dr. Kleid’s
report contains a review of Mrs. Yalacki’s medical record, as well as a discussion of his evaluation of her. See
generally id. He conducted a form of video surveillance over three- and six-day periods in February, April, and
September of 2016. Id. at 2, 12. He proposed other diagnostic tests, including a treadmill stress test, which Petitioner
declined to undergo. Id. at 12. Based on his review of the records and the video surveillance of Mrs. Yalacki, Dr. Kleid
concluded that she suffers from POTS and CFS. Id. at 13. However, because his opinion bears only on her 2016
condition—five years after the vaccination at issue—and because he was not called to testify, I give his written opinion
very little weight.

32
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; see also
Shalala v. Whitecotton, 514 U.S. 268, 270 (1995) (quoting 42 U.S.C. § 11(c)(1)(C)(i)); Moberly
v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of
Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).32 Petitioner in this case asserts
only a non-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).
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).

When a Table Injury claim is successfully established, causation is presumed. 42 C.F.R.
§ 100.3. Table claims must satisfy with evidence the specific elements of the relevant claim,
including the definitions of terms set in the Qualifications and Aids to Interpretation (the “QAI”).
Section 14(b). Case law underscores that, to obtain the benefit of the presumption of causation
associated with a Table claim, the claim’s requirements must be strictly construed. Miller v. Sec’y
of Health & Human Servs., No. 02-235V, 2015 WL 5456093, at *24 (Fed. Cl. Spec. Mstr. Aug.
18, 2015) (requiring petitioner to satisfy the “strict Table definition” of encephalopathy).

For a non-Table claim, proof of medical certainty is not required. Bunting v. Sec’y of Health
& Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In such circumstances, a petitioner must
demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial
factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health
& Human Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human
Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner asserting a non-Table claim must satisfy
all three of the elements established by the Federal Circuit in Althen v. Secretary of Health &
Human Services: “(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.” 418 F.3d
1274, 1278 (Fed. Cir. 2005).

32
Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121,
124 (2003), aff’d, 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-
159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

33
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, the
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory
must only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009)
(citing Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not
empowered by statute to conclusively resolve what are essentially thorny scientific and medical
questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through
the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant
evidence standard.” Id. at 1380. Accordingly, special masters must take care not to increase the
burden placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v.
Sec’y of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844
F.3d 1363 (Fed. Cir. 2017).

In discussing the evidentiary standard applicable to the first Althen prong, many decisions
of the Court of Federal Claims and Federal Circuit have emphasized that petitioners need only
establish a causation theory’s biologic plausibility (and thus need not do so with preponderant
proof). Tarsell v. United States, 133 Fed. Cl. 782, 792–93 (2017) (special master committed legal
error by requiring petitioner to establish first Althen prong by preponderance; that standard applied
only to second prong and petitioner’s overall burden); Contreras, 121 Fed. Cl. at 245
(“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis in
original)); see also Andreu, 569 F.3d at 1375. At the same time, there is contrary authority from
the Federal Circuit suggesting that the preponderance standard applied when evaluating a
claimant’s overall success in a Vaccine Act claim also bears on the first Althen prong. See, e.g.,
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010) (affirming
special master’s determination that expert “had not provided a ‘reliable medical or scientific
explanation’ sufficient to prove by a preponderance of the evidence a medical theory linking the
[relevant vaccine to relevant injury]”) (emphasis added). Regardless, one thing remains: petitioners
always have the burden of establishing their Vaccine Act claim overall with preponderant
evidence. W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations
omitted); Tarsell, 133 Fed. Cl. at 793 (noting that Moberly “addresses the petitioner’s overall
burden of proving causation-in-fact under the Vaccine Act” by a preponderance).

34
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record—including conflicting
opinions among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742,
749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’
conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health &
Human Servs., 100 Fed. Cl. 119, 136 (2011), aff’d, 463 F. App’x 932 (Fed. Cir. 2012); Veryzer v.
Sec’y of Health & Human 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. App’x 765 (Fed. Cir. 2012).

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

35
11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review denied (Fed.
Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law 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 & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the
events in question that was given at a later date, provided that such a determination is evidenced
by a rational determination).

Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”); Rickett v. Sec’y of Health & Human
Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is based
on the linked propositions that (i) sick people visit medical professionals; (ii) sick people honestly
report their health problems to those professionals; and (iii) medical professionals record what they
are told or observe when examining their patients in as accurate a manner as possible, so that they
are aware of enough relevant facts to make a

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/4374299. Public record. Not legal advice.