# McCabe v. Secretary of Health and Human Services

> United States Court of Federal Claims · June 19, 2018

URL: https://www.frixlaw.com/law-library/cases/4285796

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** June 19, 2018
- **Precedential status:** Published
- **Opinion:** Opinion
- **Judges:** Christian J. Moran
- **Cited by:** 0 later opinions in the Frix Law Library

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## How later opinions describe it (automated extraction)

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## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
*************************
CATHERINE GERTRUDE McCABE, *
* No. 13-570V
Petitioner, * Special Master Christian J. Moran
*
v. * Filed: May 17, 2018
*
SECRETARY OF HEALTH * Entitlement, flu vaccine,
AND HUMAN SERVICES, * chronic fatigue syndrome.
*
Respondent. *
*************************
Clifford Shoemaker, Shoemaker, Gentry & Knickelbein, for petitioner;
Glenn MacLeod, United States Dep’t of Justice, Washington, DC, for respondent.

PUBLISHED DECISION DENYING COMPENSATION1
Petitioner, Catherine Gertrude McCabe, alleges that influenza (“flu”)
vaccinations caused her to develop chronic fatigue syndrome (“CFS”).2 Ms.
McCabe is seeking compensation pursuant to the National Childhood Vaccine
Injury Compensation Program, codified at 42 U.S.C. § 300aa−10 through 34
(2012).
Ms. McCabe puts forth the opinions of two experts, who together argue that
her 2010 flu vaccine, perhaps in conjunction with previous flu vaccines, caused
dysregulation of Ms. McCabe’s immune system and/or neurological damage. This

1
The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services), requires that the Court post this decision on its
website. Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing
redaction of medical information or other information described in 42 U.S.C. § 300aa-12(d)(4).
Any redactions ordered by the special master will appear in the document posted on the website.
2
There is a substantial amount of debate about the naming of the condition widely
referred to as chronic fatigue syndrome. The syndrome has also been called myalgic
encephalomyelitis (“ME”) and a combination of the two: ME/CFS. The undersigned does not
take any position on the name and uses CFS in this document. However, when referencing
another source, the terminology used by the referenced source is used.
dysregulation and/or neurological damage, in turn, allegedly caused her to develop
CFS, or significantly aggravated her pre-existing CFS. The Secretary disagrees.
The Secretary argues that Ms. McCabe does not have CFS, that the flu vaccine
cannot cause CFS, and even if it could, it did not do so here.
Ms. McCabe’s claim fails for several overlapping reasons. The foundational
issue is that Ms. McCabe’s health before and after the 2010 flu vaccination appears
unchanged. Without a persuasive showing that Ms. McCabe’s health worsened,
Ms. McCabe cannot establish that the September 11, 2010 flu vaccination either
caused her to suffer from CFS or significantly aggravated her pre-existing CFS. In
addition, the evidence does not support a diagnosis of CFS, a condition that none
of Ms. McCabe’s treating doctors have diagnosed her with. Furthermore, Ms.
McCabe fails to present persuasive evidence supporting a potential causal link
between the flu vaccine and CFS. As a result of petitioner’s failure to demonstrate
that she suffered a cognizable injury and her failure to provide sufficient evidence
of causation, her claim for compensation must fail.
I. Facts
Information about the events in Ms. McCabe’s life is drawn from two
sources: records and testimony. The records primarily consist of medical records
that describe her health. Because of the importance of contemporaneously created
medical records (see Cucuras v. Secʼy of Health & Human Servs., 993 F.2d 1525,
1528 (Fed. Cir. 1993)), the medical records are summarized first, in section A
below. Section B provides a summary of the oral testimony from Ms. McCabe.
A. Medical Records3
A critical issue is whether Ms. McCabe’s health changed shortly after the
September 11, 2010 flu vaccination. To facilitate an analysis that compares and
contrasts her health, this section is divided into discrete times. Section 1 presents
information from Ms. McCabe’s medical records before September 11, 2010.
Section 2 reviews Ms. McCabe’s health for the year after the September 11, 2010
vaccination. Section 3 summarizes Ms. McCabe’s health from 2011 until the most
recent medical records were filed.

3
Ms. McCabe also filed employment records, which are discussed in the context of
comparing her functioning before and after vaccination. See Section IV.B.1, below.
2
1. Prior to the September 11, 2010 Flu Vaccination
Ms. McCabe was born on November 17, 1959. Ms. McCabe’s primary care
physician leading up to the time of her vaccination and for several years after was
Dr. Ja Gu Kang. Unfortunately, portions of Dr. Kang’s records are illegible.
Though the entire record has been reviewed, the facts presented here focus on
those portions of the record that legibly state Ms. McCabe’s symptoms at her
regular visits as well as other major health events (e.g., hospital visits). Because
Ms. McCabe alleges the vaccine affected her chronic fatigue syndrome, specific
emphasis is placed on records associated with fatigue (e.g., insomnia, depression,
and records of treatment associated with fatigue).
In the years before her 2010 vaccination, Ms. McCabe repeatedly noted she
experienced depression, insomnia, and/or fatigue. These features are noted on the
following 20 dates: 10/2/06, 12/2/06, 1/6/07, 2/26/07, 3/9/07, 3/31/07, 5/12/07,
6/9/07, 9/29/07, 11/24/07, 5/12/08, 2/17/09, 5/2/09, 9/17/09, 10/19/09, 12/21/09,
2/19/10, 6/3/10, 7/15/10, and 9/11/10 (the date of the vaccination in question).
Exhibit 1 at 1-12.4
Consistent with these reports of fatigue, Ms. McCabe also was repeatedly
administered shots of vitamin B12. These shots are noted on 10/2/06, 3/9/07,
3/31/07, 4/7/07, 5/12/07, 6/9/07, 9/29/07, 11/10/07, 11/24/07, 5/12/08, 12/13/08,
2/19/10, 4/9/2010, and 7/15/2010 (14 times). The purpose of the B12 shots is not
indicated in Dr. Kang’s notes, but Ms. McCabe testified they were to help with her
fatigue. See Tr. at 64 (“Lack of sleep and tiredness. I had been very tired. Now, I
don't know if that’s been ten years ago or if it’s from the flu vaccine, but I am just
constantly tired. So that’s why I was getting B12 shots, to give me energy.”) Ms.
McCabe was also being treated with Effexor (an anti-depressant), Ambien (a sleep
aid), and lorazepam (a benzodiazepine used to treat anxiety disorders, among other
things). Exhibit 1 at 1-12.
In addition to fatigue, depression, and insomnia, Ms. McCabe’s medical
records indicate that she often presented with a persistent cough and diagnoses of
COPD, bronchitis, and asthma were noted throughout Dr. Kang’s record. Id.
Beyond these chronic conditions, Ms. McCabe’s records indicate that she
was treated for other injuries and diseases as well. On April 4, 2008, she was seen
in emergency care for a fall. Exhibit 1 at 48; exhibit 3 at 88. X-rays showed no

4
Due to the illegibility of Dr. Kang’s handwriting, it is impossible to say if these features
appeared in addition to the times noted above. These are the dates when they were legibly noted.
3
fracture, but did reveal spondylosis, patchy opacification, lumbar lordosis, and
degenerative changes. Exhibit 1 at 44-45.
A DEXA scan performed on November 11, 2008, showed borderline
osteopenia. Id. at 60. A bone density study of the lumbar spine showed
compression deformities of the inferior endplates of L3 and L4 and borderline
osteopenia in L5. Exhibit 3 at 135.
On December 4, 2008, she was admitted to the hospital for constipation and
constant abdominal pain. Id. at 21. An ultrasound of the abdomen suggested fatty
infiltration of the liver and gallbladder polyps. Exhibit 1 at 63. A colonoscopy
with upper gastrointestinal endoscopy was performed, with results reported as
normal. Testing for celiac disease was ordered and later reported negative. Id. at
73. Duodenal biopsies were reportedly unremarkable on December 6, 2008, noting
mild reactive gastropathy. Id. at 59.
A barium enema performed on April 3, 2009 showed several diverticuli.
Exhibit 3 at 129. Anxiety, insomnia, and frequent bowel movements for three days
were noted on October 19, 2009. Stool cultures were obtained. Exhibit 1 at 9-10.
A week later, on October 27, 2009, Ms. McCabe was seen for bloody stools and
was diagnosed with pinworm and giardia. Id. at 10. A colonoscopy performed on
February 18, 2010 and was reportedly “ok.” Id. at 10-13. She was diagnosed with
irritable bowel syndrome on April 9, 2010. Id. at 11. Acute cystitis and insomnia
were noted on June 3, 2010. Id. Insomnia, anxiety, depression, neck pain, chest
pain, musculoskeletal pain, bronchitis, gastritis, and tarry stools were noted on July
15, 2010. Id.
Throughout these visits, Ms. McCabe received flu vaccinations on October
2, 2006, September 29, 2007, and October 19, 2009, without any reported
problems.5 Id. at 2, 5, 9.
2. The September 11, 2010 Flu Vaccination and the Following Year
Ms. McCabe visited Dr. Kang on September 11, 2010. Id. at 12. The first
notation in Dr. Kang’s records from that day records that Ms. McCabe was, again,
experiencing fatigue. Id. Dr. Kang also noted gastroesophageal reflux (GERD),

5
Although there is no record of a flu vaccination for 2008, petitioner’s brief reports that
Ms. McCabe was certain that she did receive one that year. Pet’r’s Pre-Hear’g Br., filed Sep. 11,
2017, at 3.
4
depression, and anxiety. Id. She was also, again, given a B12 shot. Id. During
this visit, Ms. McCabe received a flu shot. Id.
An undated VAERS form, referenced by Sanofi-Pasteur in a letter dated
October 25, 2010, identified the site, time, and date of vaccination as right deltoid,
at 11:00 A.M. on September 11, 2010. Id. at 93. A VAERS form dated October
22, 2010, memorialized onset of adverse symptoms at 8:00 P.M. on September 11,
2010. The list of adverse occurrences included vision loss, disorientation,
unsteady gait, nausea, excessive sleep, and lightheadedness. Id. at 91.
Although the VAERS form suggests an onset of problems on September 11,
2010, Ms. McCabe first sought treatment on September 22, 2010. On that date,
Ms. McCabe went to the emergency department of NYU Medical Center for
diffuse weakness and malaise. Exhibit 2 at 6. It was noted that Ms. McCabe had
received an influenza vaccine yearly for 9 years prior to the vaccination on
September 11, 2010. Id. The notes state that she had received the immunization
around 11:00 A.M. on September 11, 2010. Id. At about 5:00 P.M., she suddenly
began to feel diffusely weak, fatigued, and achy, particularly in her shoulders. Id.
She went to bed and slept till 1:45 P.M. the next day. Id. She continued to feel
nauseated, lightheaded, and fatigued when she woke up. Id. She reported
swelling at the injection site in her left arm and a fever of 101. Id. The notes state
that she slept through the day and night and felt sufficiently improved to go to
work on Monday, September 13, 2010. Id. “Since then the p[atien]t has had a
waxing and waning course of lightheadedness, decreased appetite, woozy feeling,
sluggish fatigue with nausea and intermittent h[ead]a[che] and blurred vision but
no diplopia. She denies any focal neurological complaints.” Id. The ER notes
further state that she worked every day and developed a productive cough, nasal
pressure, and sinus pain. She had no fever and experienced intermittent chest
pressure. Id. She went to the ER on September 22, 2010 because “it was a
particularly bad day and she ‘felt like I could not function.’” Id.

Medical personnel observed the following: Ms. McCabe’s gait was steady,
she had normal speech, and she was awake, alert, and oriented according to the
nurse’s intake. Id. at 19, 28. Her blood pressure was 143/91, heart rate was 81,
and she was afebrile. Id. Strength was full and reflexes were symmetrical with
downgoing toes. Id.

Dr. Boes, an emergency physician, opined based on these observations:

50y[ear] o[old] r[ight] h[anded] f[emale] w[ith] diffuse body aches
and weakness w[ith] cough and sinus pressure with many
5
constitutional symptoms occurring after a flu shot 10 days ago.
P[atient]t’s neuro exam [is] normal except for mild Romberg and
tandem difficulty which may be near baseline for this p[atien]t who
gets regular B12 supplementation. Presentation [is] not suggestive of
acute neurological issue but instead c[onsistent] w[ith] viral syndrome
or noninfectious inflammation associated in response to the vaccine.
Although the p[atien]t’s symptoms are often experienced after the flu
shot they do not often persist for 10 days.

Id. at 7.

A CT of the brain was read as normal. Exhibit 1 at 95. Chest x-rays showed
degenerative changes in the thoracic spine. Id. at 98. Ms. McCabe was discharged
later that same day with instructions to return if symptoms worsened. Exhibit 2 at
17, 20.

On September 24, 2010, Ms. McCabe was seen by a neurologist, Dr.
Herbstein. Exhibit 1 at 106. She complained of imbalance, her legs feeling weak,
intermittent memory issues, and difficulty with daily functioning. Id. She
described that “there is a kind of bricks in my head.” Id. Dr. Herbstein
documented an essentially normal neurological examination. Id.

A brain MRI obtained on that same day showed three punctate
hyperintensities in right frontal white matter, which were read as a nonspecific
finding. Id. at 100. A vestibular nystagmogram (VNG) showed normal and
symmetrical responses to caloric stimulation and normal performance of
oculomotor tasks. Id. at 123. Dr. Herbstein noted in a letter dated October 1,
2010, that Ms. McCabe “[s]tates that she slept for a day and afterward she had no
memory that slowly started to come back” and that he was “not sure at this point as
to what the cause was for the transient neurological dysfunction that she reports.”
Id. at 110.

Dr. Kang noted on October 2, 2010, that Ms. McCabe reported feeling off-
balance and feverish. Dr. Kang diagnosed an upper respiratory tract infection. Id.
at 13.

On October 7, 2010, Dr. Herbstein noted that “her neurological examination
remains entirely normal with 2/5 symmetrical reflexes, downgoing toes, normal
strength, and normal cerebellar examination.” Id. at 116. Dr. Herbstein further
noted that “Ms. McCabe insists that her symptoms started after she had the flu
6
shot, but I failed to find any objective abnormalities on my neurological
examination.” Id.

Also on October 7, 2010, she was seen by Dr. Osterweil, an
otolaryngologist. Id. at 131. Ms. McCabe complained of neurological symptoms
including vertigo and gait disturbance. Id. Dr. Osterweil reported that VNG,
balance tests, and reflex tests indicated no abnormalities. Id. He further reported
that he did not associate the MRI hyperintensities to her symptoms. Id. Other than
indications of allergic rhinitis and postnasal drip, the exam was reported as
unremarkable. Id.

Ms. McCabe also began physical therapy on October 7, 2010. Exhibit 7 at
14. The records show that Ms. McCabe was “ambulating very well without cane”
and that “patient’s complaints of significant weakness and numbness [are] not
consistent with findings for normal gait.” Id. Future records from the physical
therapist continue to note that Ms. McCabe’s reports of having poor balance are
inconsistent with her ability to “stop short with minimal loss.” Id. at 22, 24, 26,
28.

Between October 11 and October 13, 2010, Ms. McCabe underwent an
ambulatory EEG examination. Exhibit 5 at 8. During these exams, patients push a
button when they experience a symptom of their condition so that physicians may
be able to associate the symptom with certain brain activity. This examination
revealed that the 77 push-button events for various neurological complaints
reported by Ms. McCabe were not associated with abnormal activity. Id. at 9.
However, occasional left anterior temporal sharp waves were noted during sleep
and rarely during wakefulness. Id. at 8-9.

On October 19, she was seen again by Dr. Kang, who noted complaints of
coughing, headache, ear ringing, decreased memory, and heaviness. Exhibit 1 at
14. Dr. Kang diagnosed acute sinusitis and bronchitis. Id.

Dr. Herbstein noted in a letter dated October 26, 2010, that “[s]he continues
to complain of terrible memory issues, unsteadiness, weakness, numbness of the
extremities, bone pains, etc. She is convinced that all of this is the result of the flu
vaccine. Neurological examination remains within normal limits.” Exhibit 6 at 7.

On October 28, 2010, Ms. McCabe saw a pulmonologist, Dr. Chae, for
trouble breathing, a cough lasting six weeks, and postnasal drip. Exhibit 4 at 10.
Dr. Chae concluded that there was normal pulmonary function and concluded that
7
her condition was “likely self limited.” Id. Four days later, Dr. Chae noted that he
had had a follow-up discussion with Ms. McCabe and that “she is feeling a bit
better.” Id. at 11.

On November 1, 2010, Ms. McCabe was seen by Dr. Forster, a neurologist,
for a second opinion of Dr. Herbstein’s diagnosis. Exhibit 1 at 132. Dr. Forster
noted that since seeing Dr. Herbstein, “she has progressively gotten better.” Id.
Dr. Forster ultimately concluded that “the current examination is grossly without
focal dysfunction” and that he did not think that “beyond the tincture of time and
physical therapy there is anything specific that needs to be done.” Id. at 133. He
concludes “I do think that she suffered a ‘viral’ illness which must take its course.”
Id.

Following the visit with Dr. Forster on November 1, 2010, there was an
extended period of time without any records of medical treatment or complaints.
This gap ends on March 8, 2011, when she returned to see Dr. Forster. Exhibit 8 at
7. Dr. Forster notes: “she is absolutely convinced that the flu vaccine has been the
cause of all her symptoms. She complains of loss of memory, pains in legs,
swelling of the legs, some blurring of vision, etc. She also reports that she is
depressed.” Id. Dr. Forster prescribed her Cymbalta and Lyrica. Id. at 8.

Ms. McCabe underwent a neuropsychological evaluation on May 2 and 23,
2011. Exhibit 8 at 15. The evaluation indicated that she performed within the
“average range of intellectual and cognitive functioning.” Id. at 19. Further, the
neuropsychologist noted that her cognitive functioning was “consistent with our
estimate of her premorbid level of intellectual functioning.” Id. at 20.

Throughout Ms. McCabe’s visits in the year following her vaccination, there
is no indication that any treating physician associated her ongoing symptoms as
being a consequence of the flu vaccine she received on September 11, 2010.

3. From a Year Following Vaccination to Today
Ms. McCabe returned to Dr. Kang for a cough on September 2 and 8, 2011.
Dr. Kang diagnosed her with acute bronchitis and general anxiety disorder.
Exhibit 1 at 15. On the second visit, Dr. Kang referred her again to Dr. Chae, the
pulmonologist. Id.

Ms. McCabe saw Dr. Chae on September 9, 2011, and complained of feeling
weak and tired. Exhibit 4 at 2. Again, the medical records note that she stated that
8
she “[o]verall feels not herself and weaker with leg pains and memory loss since
she had the flu shot 9/10.” Id. Dr. Chae’s records note that Ms. McCabe was
being treated for fibromyalgia, although this diagnosis does not appear in Dr.
Forster’s records. Id. Dr. Chae did not report any significant abnormal findings
and noted that the cough seemed to be resolving. Id. He also stated “[s]he is now
most concerned with subjective fevers and fatigue.” Id.

On a visit to Dr. Kang on December 3, 2011, Ms. McCabe complained of
coughing. Exhibit 1 at 16. During this visit, it was noted for the first time that Ms.
McCabe’s brother has hemochromatosis.6 Id. Fatigue does not appear to be
mentioned, though a B12 shot was administered. Id. Dr. Kang considered acute
bronchitis, rhinosinusitis, generalized anxiety disorder, and hemochromatosis as
diagnoses. Id.

Beyond December 3, 2011, petitioner’s medical records show a number of
visits to specialists that do not appear to relate to the present case. These include
referrals to an orthopedist (exhibit 1 at 147-48), endocrinologist (exhibit 1 at 154),
an otolaryngologist (exhibit 1 at 157-58), a cardiologist (exhibit 1 at 160-61), and a
podiatrist (exhibit 1 at 20). Although the undersigned has reviewed these medical
records, they do not appear to be material and were not developed at the hearing or
in the parties’ pre-hearing briefs. They also do not appear to relate to the central
issue here, which is petitioner’s reported symptoms and diagnoses before and after
the September 11, 2010 flu vaccine as they relate to petitioner’s putative CFS.

On March 24, 2012, petitioner presented to Dr. Kang complaining of
anxiety, cough, stuffy nose, insomnia, leg pain, and GERD. Exhibit 1 at 16.
Again, fatigue does not appear to be noted on this visit, although a B12 shot was
provided. Id. On April 18, 2012, she presented with depression, insomnia, and a
stuffy nose. Id. at 17. Allergic rhinitis, acute rhinosinusitis, depression, insomnia,
and GERD were considered as diagnoses. Id.

On June 16, 2012, she presented with shortness of breath, sore throat, and
coughing. Id. Again, fatigue was not noted, although a B12 shot was given.
Depression and acute bronchitis were also considered. Id.

6
Hereditary hemochromatosis is a disorder of iron metabolism that is hallmarked by
excessive amounts of iron entering the circulatory pool and accumulating in the tissues.
Dorland’s Illustrated Medical Dictionary 838 (32d ed. 2011).
9
On July 21, 2012, she presented with shortness of breath and heart
complaints. Exhibit 1 at 18. COPD was considered. Id. At this visit, no fatigue
was noted and it does not appear that a B12 shot was given. Id. She did wear a
Holter monitor for 24 hours, which showed a mean heart rate of 93 and intermittent
sinus tachycardia. Id. at 164.

On August 10, 2012, she was seen for a sore throat and burning while
urinating. Id. at 18. Fatigue was not noted, although a B12 shot was given. Id.
Dr. Kang considered acute cystitis, GERD, anxiety, and allergic rhinitis as possible
diagnoses. Id.

She was seen on November 6, 2012, with primary complaints of fatigue and
stuffy nose. Id. at 19. Chronic bronchitis, depression, and leg pain were also
noted. Id.

On December 17, 2012, Ms. McCabe was seen for shortness of breath,
coughing and congestion. Id. Fatigue was not noted, although a B12 shot was
given. Id. Dr. Kang considered acute and chronic bronchitis, and anxiety.
“Ireland” was noted in the medical records. Id.

On April 2, 2013, she was seen for burning urination and left hip and lower
back pain. Id. at 20. Fatigue was not noted, although a B12 shot was
administered. Id.

On May 18, 2013, she was seen for a swollen left foot. Id. Though fatigue
is not noted, insomnia is noted and a B12 shot was administered. Id. COPD was
also considered among the diagnoses. Id.

On May 25, 2013, menopause was noted in the medical records for the first
time. Exhibit 100 at 15. She was prescribed Prozac, with the notation that it may
have been “for menopause.” Id. Fatigue was not noted, and no B12 shot was
administered. Id.

On July 13, 2013, she presented with insomnia, anxiety, and coughing.
COPD, anxiety, rhinitis, and GERD were considered as diagnoses. Id. No report
of fatigue was made and it does not appear that a B12 shot was given. Id.

On August 16, 2013, she presented with coughing, which produced yellow
sputum. Id. She noted being both cold and warm. Id. Fatigue was not noted,

10
although a B12 shot was administered. Id. Acute bronchitis, rhinitis, and COPD
were noted. Id.

On September 28, 2013, she was seen for neck pain and shortness of breath.
Id. at 14. While the records from this date are especially difficult to read, again
fatigue was not apparently noted, but a B12 shot was administered. Id. COPD and
chronic bronchitis were noted in the records. Id.

She was seen on December 6, 2013, though the notes are again especially
difficult to decipher for this visit. Id. at 13. The presenting issue appears to be
related to stomach pain, and GERD was noted. Id. Fatigue does not appear to be
noted and a B12 shot does not appear to have been administered. Id.

On February 4, 2014, she was seen for a nasal allergy and a cough that
produced sputum. Id. at 12. Acute bronchitis, COPD and depression were noted.
Id. Fatigue was not noted, although a B12 shot was administered. Id.

On April 3, 2014, a retroesophageal subclavian artery was noted.7 Id. at 11.
COPD, depression and anxiety, and rhinitis were also considered. Id. Fatigue was
not noted. While it appears that Ms. McCabe requested a B12 shot, whether it was
administered is not clear.

On June 2, 2014, she presented with anxiety, COPD, and shortness of breath.
Id. at 10. COPD, anxiety, and depression were recorded as diagnoses. Id. No
mention is made of fatigue or a B12 shot. Id.

On June 30, 2014, anxiety, palpitations and tachycardia, and COPD were
noted in her records. Id. at 9. Sinus tachycardia, anxiety, COPD, and depression
were considered as diagnoses. Id. No note of fatigue is found in the record,
though a B12 shot was given. Id.

On September 20, 2014, she presented complaining of shortness of breath,
coughing, depression, and anxiety. Id. at 8. Acute bronchitis, COPD, anxiety, and
depression were considered. Id. There is no note of fatigue, although a B12 shot
was given. Id.

7
As its name suggests, a retroesophageal subclavian artery is a congenital defect where
the subclavian artery passes behind the esophagus, instead of in front of it. Tr. 690.
11
On October 30, 2014, she presented complaining of leg and foot pain, short
term memory loss, and concentration deficits. Id. at 7. Dr. Kang considered
dysphagia, anxiety, menopause, insomnia, and COPD. Id. There is no mention of
fatigue, although a B12 shot was given. Id.

On December 11, 2014, she presented with acute glaucoma, stuffy nose, and
coughing. Id. at 4. Acute bronchitis, acute rhinosinusitis, COPD, anxiety, and
insomnia were noted. Id. There is no mention of fatigue, although a B12 shot was
noted as requested. Id. The records do not indicate if it was given. Id.

On February 17, 2015, she presented complaining of coughing. Id. at 3.
Acute bronchitis, COPD, anxiety, insomnia, and GERD were considered as
diagnoses. Id. No note of fatigue or a B12 shot is found in the record. Id.

On March 20, 2015, Ms. McCabe began seeing Dr. Malik Megjhani
following Dr. Kang’s retirement. Id. at 24; Tr. 121. Fortunately, Dr. Megjhani
kept legible records. On that day, Ms. McCabe presented with a chief complaint of
cold, cough, shortness of breath, and cold sweats. Exhibit 100 at 24. She also
reported general malaise. Id. She was diagnosed with an upper respiratory
infection, COPD, and allergic rhinitis. Id. No fatigue was noted, though a B12
shot was administered. Id.

On April 11, 2015, she saw Dr. Megjhani for a prescription renewal. Id. at
27. No other complaints were noted other than pain in her left foot. Id. Dr.
Megjhani noted “no systemic symptoms” and maintained an assessment that
included allergic rhinitis, COPD, GERD, insomnia, and anxiety. Id. She also
states that she wanted to be tested for hemochromatosis because her relatives have
it. Id. There was no note of fatigue or a B12 shot. Id.

On April 14, 2015, she had an appointment for the purposes of getting blood
work done. Id. at 30. She requested and received a B12 shot, though no note of
fatigue was made. Id. She also reported that she was not experiencing malaise or
any other systemic symptoms. Id.

On August 8, 2015, she was seen in an office visit by Dr. Min Young Kim.
Id. at 37. Her chief complaint was left shoulder pain and she requested a
prescription renewal. Id. The records note that she is “doing well no complaints”
and has “no intercurrent health problems.” Id. Dr. Kim assessed her with COPD,
GERD, insomnia, and shoulder pain. Id. at 39.

12
On September 10, 2015, she complained of a sore throat. Id. at 41. She
otherwise stated that she was not experiencing malaise. Id. There was no report of
fatigue, but a B12 shot was administered. Id.

On February 2, 2016, she presented with a chief complaint of a cough and
requesting a prescription refill. Id. at 45. She reported that she is not experiencing
malaise. Id. No note of fatigue is made, though she is assessed with insomnia, an
upper respiratory infection, and B12 insufficiency. Id.

On March 31, 2016, she presented for a prescription refill and a B12
injection. Id. at 49. She also noted her ongoing anxiety and insomnia. A battery
of labs was ordered to address her fatigue. Exhibit 11 at 52.

On May 27, 2016, she presented for a prescription refill. Exhibit 100 at 53.
She also complained of chronic nasal congestion and snoring at night. Id. No
systemic symptoms were reported. Id. She was given a shot of B12, though the
record does not note fatigue. Id. For this visit she was referred to an ENT,
physical therapist, and a sleep study. Id. This is the first of, at least, two times that
Ms. McCabe was referred for a sleep study. According to her testimony, she has
never completed the ordered sleep study. Tr. 127. The ENT diagnosed her with
chronic sinusitis and granulomatous disease.8 Exhibit 100 at 61.

On July 16, 2016, she presented for a B12 shot and a prescription refill. Id.
at 57. In this visit she complained of nasal congestion, shortness of breath, and
fatigue. Id.

On September 8, 2016, she presented for her annual physical. Id. at 61. She
complained of a dry cough and also requested a B12 shot. Id. No other symptoms,
including fatigue, were noted. Id. During this physical, she was given a patient
health questionnaire. She was asked if, over the past two weeks, she experienced
(1) “Little interest or pleasure in doing things” or (2) “Feeling down, depressed, or
hopeless?” She responded “no” to both. Id. at 64.

8
Granulomatous disease is an immune disorder caused by dysfunction of certain immune
cells that protect the body from infections. The disease is characterized by frequent infections,
particularly pneumonia and other infections of the lung. Chronic Granulomatous Disease, Mayo
Clinic (accessed May 10, 2018), https://www.mayoclinic.org/diseases-conditions/chronic-
granulomatous-disease/symptoms-causes/syc-20355817.
13
On September 30, 2016, she was seen by Dr. Eugene Shostak, based on a
referral from Dr. Megjhani. Id. at 126. Dr. Shostak noted that Ms. McCabe was
being seen for a chronic cough, lasting five years. Id. He notes that she stated that
“[s]he has never had any prior breathing problems until she got a flu shot and
developed a severe allergic reaction requiring admission to NYU Langone Medical
Center. Since then her cough never stopped.” Id. He stated “[s]he denies fever,
chills, malaise, fatigue, weight loss.” Id. Dr. Shostak referred Ms. McCabe to Dr.
Michael Chandler, since Dr. Shostak’s assessment of her condition was that
sinusitis was the cause of her problem. Id. at 128.

On October 16, 2016, she was seen by Dr. Chandler. Id. at 129. Dr.
Chandler diagnosed right sphenoid sinusitis and an infected nasopharyngeal cyst.
Id. at 133. He concluded that these conditions were consistent with her
laryngospastic symptom patterns. Id. at 133. His overall impression was “[l]ow-
grade background of allergy with isolated sphenoid sinusitis and a complex
architecture of her nose with a significant leftward septal deviation.” Id.

On November 7, 2016, she presented to Dr. Megjhani for a prescription refill
and also requested a B12 shot. Id. at 68. She complained of chronic nasal
congestion and snoring at night. Id. No other systemic issues were identified. Id.
at 69.

On December 19, 2016, she presented with a chief complaint of cough and
nasal congestion. Id. at 72. She also reported experiencing malaise. Id. She was
assessed with allergic rhinitis, primary insomnia, and anxiety disorder. Id.

On January 21, 2017, she presented with a chief complaint of chest pain,
shortness of breath, sore throat, cough, and fatigue. Id. at 75. She was assessed
with an upper respiratory infection. Id. at 77.

On February 15, 2017, she presented to Dr. Zaza Aivazi with a chief
complaint of chest pain and cough. Id. at 79. Dr. Aivazi assessed her with mitral
regurgitation, tricuspid regurgitation, COPD, prediabetes, and anxiety disorder. Id.
at 82.

On April 18, 2017, she was seen for a prescription renewal and B12 shot.
Id. at 170. At the renewal, she reported still experiencing anxiety and difficulty
falling asleep. Id. Otherwise she was reported as having no apparent disease. Id.
She was assessed with anxiety disorder, insomnia, allergic rhinitis, and GERD. Id.
at 171.
14
In the last visit in the records, on September 11, 2017, she was seen with a
primary complaint of shortness of breath, pain in her foot, feeling tired, and losing
weight. Id. at 173. During the evaluation, Ms. McCabe reported that “she
developed leg edema, burning sensation in the feet, snoring, [shortness of breath]
and other chest issues only after getting flu shot.” Id.

Though the record indicates that Ms. McCabe would sometimes state to her
treating physicians that the flu vaccine was the cause of all her symptoms, in the
seven years of medical records following the vaccination there does not appear to
be a single treating physician that documented a belief that the vaccine was the
cause of Ms. McCabe’s ongoing condition.

B. Ms. McCabe’s Testimony
Ms. McCabe testified that she was born in Ireland and moved to New York
City around 1982, where she resides now. Tr. 13-14. She had, approximately, a
9th grade education. Tr. 12; exhibit 8 at 14. When she moved to the United States,
she first worked as a waitress. Tr. 14. Around that time, she became a U.S. citizen
and she trained to become a nurse’s aide. Tr. 16. After receiving her certification,
she began a career as a full-time in-home aide. Tr. 16-17. She continued in this
career up and through the time of the September 11, 2010 vaccination.
Ms. McCabe stated that “[e]verything was great” when asked what her life
was like prior to the vaccination. Tr. 17. “[E]verything was just 100 percent.” Id.
She reported that prior to the vaccination she liked to hike, play ping pong, go on
walks, “parties, had a lot of good friends, go to showers, weddings, all that stuff,
participate, like I enjoyed my life.” Id. She later added “I was very active. I was
able to be out and about. Everybody would think I was, like, a wind machine. I
was running all over the place, and I’d go to all the events. I would go out
walking. I would help people out. I would remember. I had memory that was
unbelievable.” Tr. 26.
When petitioner’s attorney asked if the history of fatigue, depression,
COPD, GERD, anxiety, and insomnia affected her life before the depression, she
said “No.” Tr. 18. She noted that “I was taking medication, but I was doing
okay.” Id.
In her testimony, Ms. McCabe’s counsel elicited additional details on her
previous activities:

15
Q. And you said that you were hiking. I think these were things that
you mentioned in your –

A. Hiking, yeah.

Q. Can you describe what you mean by "hiking"? What's the
difference between hiking and walking?

A. Like in the woods. I would be out in the woods and going to the
lakes and -- you know...

Q. And you were going to parties and dancing. Was dancing one of
your favorite things –

A. Dancing was one of my favorite things. I loved to dance, yes. It
was one of my favorite things, and I enjoyed going to Broadway
shows, and I would be swinging around at the Broadway shows. I
loved to dance, yes.

Tr. 27-28.
During her direct testimony, Ms. McCabe did present some testimony to
explain her previous reports of insomnia and depression in the medical records. In
her early testimony she stated that while she experienced these symptoms, they
were not significant and did not adversely affect her.
Specifically, when asked about the significance of her depression prior to the
vaccination she answered: “Well, basically I think it was to do with – the
depression was basically to do with menopause, I think, that's why I was on
depression pills.” Tr. 20.
Ms. McCabe similarly indicated that the insomnia she experienced used to
be different than it is now. Before the vaccination, she testified that “I just couldn't
sleep great at nights, but I did take Ambien, and I would wake up the next morning
fully refreshed.” Tr. 21. Similarly, she indicated that her fatigue did not present
her with any problems:
Q. Did your fatigue cause you any problems with work or any of your
activities that you described?
A. At that time?

16
Q. Yeah.
A. No, no, because I would be sleeping at night, so I was able to go.
Tr. 21.
However, on cross-examination she appeared to shift towards stating that her
condition prior to the September 11, 2010 vaccinations may not have been minor
but instead reflected adverse reactions to earlier vaccinations:
Q. The reason I ask is Dr. Kang's medical records for those same
periods of time I mentioned in Exhibit 1, page 1 through 7, repeatedly
talk about depression and insomnia.

A. Well, I guess they call it that if you don't sleep, insomnia, right?

Q. That's what he called it.

A. I don't know. I don't know the medical terms.

Q. But you --

A. Which year was that?

Q. 2006 and 2007, 2008.

A. Yeah. I was taking flu vaccines all of that time.

Tr. 64-65.
In describing her current medical condition, Ms. McCabe stated that “[m]y
whole life has changed. My whole life has just been turned upside down. It's like
I'm a different person. I don't get out as much as I used to. I don't dance anymore.
I had swelling all over my legs. I have still pains in my legs. I still am getting
colds on a constant basis.” Id.
When asked how she is when she wakes up from being able to sleep, Ms.
McCabe stated “I have insomnia, so I can’t – I could take an Ambien and I could
be awake all night.” Tr. 41. Again, in describing her current sleep patterns, Ms.
McCabe contrasted her current condition with her condition before the vaccine: “I
was never like this. I was always on the go. It would take a lot to hold me down.

17
Now, my whole life is just a complete nightmare. It's been a nightmare for the last
six years, a nightmare.” Tr. 41.

Ms. McCabe stated that she was no longer able to work full-time as a nurse’s
aide following the vaccination. Tr. 41. She did, however, work the week before
going to the ER on September 22, 2010. Exhibit 2 at 10; Tr. 62. She also
appeared to not stop working as a secretary at Wankel hardware. See Section
IV.B.1. In her testimony, she stated that she went back to work as a nurse’s aide
two years after the flu vaccination. Tr. 61. She further stated that she has since
been able to work part-time, intermittently. Id. She stated that today she works
“two, three days a week.” If she’s too tired, she doesn’t work. Tr. 42.
Ms. McCabe testified that prior to receiving the flu vaccine in question, she
spoke with a nurse who had had an adverse reaction to the flu vaccine. Tr. 51-52.
This conversation led Ms. McCabe to conclude that she herself had an adverse
reaction to the flu vaccine. Specifically, she recalls herself thinking: “Oh, Lily had
a reaction. Could this possibly be a reaction to the flu vaccine?”
The undersigned will return to evaluate the factual history and Ms.
McCabe’s testimony as it relates to her diagnosis in Section IV.B.2, below.
II. Procedural History, Including Presentation of Expert Reports
Ms. McCabe’s case has been pending for several years. As set forth in more
detail below, the case’s prolonged duration is attributed, in large part, to Ms.
McCabe’s multiple changes in her theory of the case. Ms. McCabe initially was
proceeding on a claim that the flu vaccine caused a demyelinating condition. After
the parties explored whether Ms. McCabe suffered a demyelinating injury, she
switched to asserting that the flu vaccine caused cytokine release syndrome (CRS).
When pressed to support this theory with reliable evidence, Ms. McCabe presented
yet another claim: that the flu vaccine caused her to develop CFS. Later, Ms.
McCabe slightly adjusted her theory of the case again by advancing the alternative
cause of action that the flu vaccine significantly aggravated her pre-existing CFS.
These separate stages are set forth below. The backbone of Ms. McCabe’s
case are the collection of expert reports. Thus, the reports from Dr. Axelrod, Ms.
Mikovits, and Dr. Levine are presented in some detail. Additionally and
importantly, the Secretary’s response to those reports and the undersigned’s orders
for more information provide context for the subsequent reports from Ms.
McCabe’s experts.

18
A. Ms. McCabe’s Initial Claim: A Demyelinating Injury
Ms. McCabe filed her original petition on August 12, 2013. Her original
petition does not allege a specific injury, but instead claims she suffered “health
issues” as a result of the vaccine received on September 11, 2010. Pet. at 1. She
filed her statement of completion on October 16, 2013, and respondent reported
that the medical records filed were sufficiently complete. Resp’t’s Status Rep.,
filed Nov. 14, 2013, at 1. The undersigned then set a deadline of January 10, 2014,
for the respondent’s Rule 4(c) report. Order, issued Nov. 18, 2013.
The undersigned extended the deadline for respondent to file his Rule 4(c)
report to March 21, 2014, due to missing medical records. Order, issued Feb. 10,
2014. Respondent timely filed his Rule 4(c) report on March 21, 2014. A status
conference was held on March 31, 2014, to discuss the contents of this report and
the next steps. The possibility of settlement and the need for additional
employment records were also discussed. Order, issued Apr. 2, 2014. In a later
status report, respondent stated that settlement would not be possible unless the
petitioner amended her petition to identify the specific injury she alleges the
vaccine caused. Resp’t’s Status Rep., filed July 8, 2014.
A status conference was held on August 18, 2014, to discuss the need for an
amended petition and additional medical records. Following the conference, the
undersigned ordered the petitioner to file her amended petition by October 2, 2014.
Order, issued Aug. 19, 2014. Petitioner was ordered to identify what injury the
vaccine caused. Id.
On October 2, 2014, petitioner filed her amended petition, stating that the flu
vaccine caused “an aggravation of a pre-existing demyelinating condition.” Am.
Pet. at 1. A status conference was held on October 8, 2014, to discuss the amended
petition. Following the status conference, petitioner was ordered to file an expert
report in 60 days. Order, issued Oct. 9, 2014. Ms. McCabe filed a report from Dr.
Axelrod on October 27, 2014. Exhibit 16.
1. Dr. Axelrod’s Background and First Report
Dr. Axelrod’s Qualifications
When he submitted his report, Dr. David Axelrod was a clinical
immunologist and Associate Professor with the Oakland University - William
Beaumont School of Medicine in Royal Oak, MI. Dr. Axelrod received an
undergraduate and medical degree from the University of Michigan. He also
received a Masters from the University of Michigan School of Public Health. He

19
states that when he worked as principal investigator at the Walter Reed Army
Institutes of Research in 1982-1984, his laboratory participated in vaccine
development.
Dr. Axelrod’s First Report (Exhibit 16)
Dr. Axelrod ultimately did not testify in this matter. However, a brief
review of the contents of his report is helpful in two ways. First, it demonstrates
how petitioner’s other experts adopted portions of his report in making their
conclusions. Second, it provides important context for understanding rebuttals
made by respondent’s experts.
Dr. Axelrod states that the “objective findings suggest dysfunction of parts
of her nervous system. This dysfunction was caused by an immune response to the
vaccine that resulted in damage/dysfunction of her central nervous system,
including demyelinating disease.” Exhibit 16 at 1.
To support his theory, Dr. Axelrod cites articles that, he says, show that
vaccination will cause elevated levels of certain compounds, including interleukin-
6 (IL-6), which will persist in time. Id. at 2-3. These compounds will, according
to Dr. Axelrod, lead to disruption of the blood brain barrier, allowing blood-borne
chemicals to enter and affect the brain. Id. Dr. Axelrod opines that these
chemicals resulted in her anxiety, depression, and the new brain demyelinating
disease that can be associated with the symptoms she experienced following the
September 11, 2010 flu vaccine. Id.
A status conference was held on November 3, 2014, to discuss Dr. Axelrod’s
report. On respondent’s request, respondent was provided 60 days to evaluate the
report to determine whether settlement was possible. Order, issued Nov. 4, 2014.
On January 5, 2015, respondent stated that he would be submitting a report from
Dr. Leist in rebuttal to Dr. Axelrod’s report. Resp’t’s Status Rep. Respondent
filed Dr. Leist’s report on February 20, 2018. Exhibit A.
2. Dr. Leist’s Background and First Report
Dr. Leist’s Qualifications
Dr. Thomas Leist is a neurologist and Professor of Neurology with Thomas
Jefferson University in Philadelphia, PA. Dr. Leist received his diploma and Ph.D.
in Biochemistry from the University of Zurich and his M.D. from the University of
Miami. He now serves as the Chief of the Division of Clinical Neuroimmunology
and the Director of the Comprehensive Multiple Sclerosis Center.

20
Dr. Leist’s First Report (Exhibit A)
Dr. Leist’s initial expert report provides a comprehensive review of Ms.
McCabe’s medical history, which was used as a basis for subsequent expert’s
reports. Exhibit A at 1-7.
Dr. Leist addresses each of the articles referenced by Dr. Axelrod and raises
a number of concerns about each. Id. at 7-8. However, it is not necessary to go
into great depth here given that petitioner decided not to rely on Dr. Axelrod’s
opinion and accompanying articles.
Dr. Leist then presents his opinion in this matter. Id. at 9. He points out that
Ms. McCabe’s alleged neurological symptoms began at approximately 4:30 P.M.
(when she alleged that she “felt so tired” and “could not stand up.”) Id. at 10. This
was approximately five hours after receiving the flu vaccine. He opines: “A four
to five hour time interval between vaccination and symptom onset is too short to
allow occurrence of such a cognate process that as Dr. Axelrod opines: ‘resulted in
damage/dysfunction of her brain related to her anxiety and depression or the
damage/dysfunction of her brain resulted in a new brain demyelinating disease.’”
Id. On the other hand, Dr. Leist opines, her symptoms were fully consistent with
an upper respiratory tract infection. Id.
Further addressing whether Ms. McCabe experienced a focal neurological
insult following the vaccination, Dr. Leist points out that examinations by several
different practitioners did not identify any focal findings. Id. Among these were
neurological examinations by Dr. Herbstein (exhibit 1 at 106), the NYU
emergency department (exhibit 2 at 7), Dr. Forster (exhibit 8 at 8), and Dr. Sivak
(exhibit 8 at 11).
As a result, Dr. Leist ultimately concludes that the influenza vaccine Ms.
McCabe received on September 11, 2010 “did not cause, contribute to, or worsen
the various health conditions from which Ms. McCabe suffered before and after
September 11, 2010.” Exhibit A at 11. He further notes that “Ms. McCabe did not
experience a demyelinating central nervous system injury or aggravate a
preexisting central nervous system injury as a result of the influenza vaccination
she received on September 11, 2010.” Id.
A status conference was held on March 2, 2015, to discuss Dr. Leist’s report.
During the status conference, petitioner was given until April 10, 2015, to file a
responsive report from Dr. Axelrod. Order, issued Mar. 3, 2015. Dr. Axelrod’s
report was timely filed on March 19, 2015. Exhibit 30.

21
3. Dr. Axelrod’s Second Report (Exhibit 30)
In his supplemental report, Dr. Axelrod again cites several articles in support
of his claim that vaccination results in elevated levels of certain compounds that
can cause damage to individuals’ nervous systems. Exhibit 30 at 1. He further
states that the effect of these compounds could be part of a primary immune
response or part of a secondary immune response. Id. at 2-3. Thus, the
vaccination could explain both her immediate symptoms and her symptoms that
developed in the days and weeks following the vaccination. Id.
* * *
In a status conference on March 30, 2015, the undersigned raised the
concern that Dr. Axelrod’s report did not address the issue of significant
aggravation, which was alleged in Ms. McCabe’s amended petition. Order, issued
Mar. 30, 2015. Respondent also requested an opportunity to review and comment
on Ms. McCabe’s MRI images. Id. Ms. McCabe was ordered to produce the
images from the MRI so that respondent’s expert could evaluate them. Id.
4. Change in Counsel and Change in Theory
During a status conference held on May 27, 2015, petitioner’s counsel of
record stated that he intended to transfer the case to substitute counsel. Order,
issued May 28, 2015. Substitute counsel entered an appearance on August 13,
2015. A status conference was set for August 27, 2015. During the status
conference, the parties reviewed the case with petitioner’s new attorney and
revisited the issue of the missing MRI images. Order, issued Aug. 27, 2015.
Petitioner also stated that she intended to have a neurologist provide an opinion.
Id. The undersigned set a deadline of October 28, 2015, for the neurologist’s
report. Id.
Petitioner sought, and was granted, enlargements of time to file the report
from a neurologist on October 26, 2015, and December 28, 2015. Orders, issued
Oct. 27, 2015, and Dec. 29, 2015. Petitioner filed a third motion for an
enlargement of time to file the neurologist’s report on January 28, 2016. The
undersigned deferred ruling on this third motion until after a status conference was
held on February 3, 2016, to discuss the reason for the delay in procuring the
report. Order, issued Jan. 29, 2016. Petitioner’s motion was granted following the
status conference. Order, issued Feb. 4, 2016. Petitioner then filed a fourth motion
for an enlargement of time to file the neurologist’s report on February 29, 2016.
This motion was granted. Order, issued Mar. 2, 2016. Petitioner then filed a fifth

22
motion for enlargement of time on April 13, 2016. This motion was also granted.
Order, issued Apr. 14, 2016.
On June 14, 2016, petitioner moved for a sixth enlargement of time to file
her expert report. However, in this motion, Ms. McCabe stated that the neurologist
from whom she had planned to procure the report had concluded that petitioner
should have an expert in ME/CFS and fibromyalgia review the records, not a
neurologist. Pet’r’s Mot. at 1. The undersigned deferred ruling on this motion until
following a status conference, which was, after being delayed, held on June 29,
2016. Order, issued June 15, 2016. During the status conference, Ms. McCabe
informed the undersigned that an expert report would be filed imminently and
respondent requested 60 additional days to file a responsive report. Order, issued
June 29, 2017. Petitioner filed a report from Ms. Mikovits the next day. Exhibit
40.9
B. Petitioner’s Second Claim – Cytokine Release Syndrome
1. Ms. Mikovits’ Background and First Report
Ms. Mikovits’ Qualifications
Ms. Judy Mikovits is a consultant with MAR Consulting Inc. She earned an
undergraduate degree in chemistry from the University of Virginia and a Ph.D. in
biochemistry from George Washington University. Ms. Mikovits did not attend
medical school and is not a licensed medical doctor.
Ms. Mikovits’ First Report (Exhibit 40)
In her first report, Ms. Mikovits puts forth that cytokine release syndrome
(CRS) is an immune related adverse event seen in a number of immune
compromised patients receiving checkpoint inhibitors. Exhibit 40 at 2. She cites
T.J. Williams et al., Association of Autoimmune Encephalitis With Combined
Immune Checkpoint Inhibitor Treatment for Metastatic Cancer, 73 J. Am. Med.
Assoc. Neurology 928 (2016)10 to support this claim. Ms. Mikovits further notes
that CRS can occur within hours of “treatment” and can be diagnosed by high
levels of several molecules, including IL-6, CRP, ferritin, and lactate. Exhibit 40
at 2. By discussing checkpoint inhibitors in the context of a claim that the flu

9
Ms. Mikovits co-authored reports with Francis Ruscetti. However, Ms. Mikovits
testified and Mr. Ruscetti did not. Therefore, for ease of reference, this decision identifies the
reports as coming from Ms. Mikovits.
10
Petitioner did not file this article into the record.
23
vaccine harmed Ms. McCabe, Ms. Mikovits implies that checkpoint inhibitors are
somehow similar to a flu vaccine, but fails to establish or to explain how. Id.
Ms. Mikovits then cites a 2011 blog post for the proposition that there have
been fatal reactions to Rituxan immunotherapy. Id. (citing Rituximab [Rituxan] –
Fatal Infusion Related Reactions in Patients with Rheumatoid Arthritis,
THERAGENOMICS BLOG (June 6, 2011), https://thassodotcom.wordpress.com/
2011/06/07/rituximab-rituxan-fatal-infusion-related-reactions-in-patients-with-
rheumatoid-arthritis/). Again, she implies that there is a reason to connect Rituxan
treatment to the flu vaccine, but she makes no attempt at connecting the two. See
exhibit 40 at 2.
Ms. Mikovits then points out that COPD, which Ms. McCabe had, is an
inflammatory disorder and further states that individuals with COPD have an
altered lung microbiome. Id. at 2-3. She continues, without support, to say that “it
is likely that vaccine induced changes in the intestinal microbiome can exacerbate
COPD symptoms.” Id. at 3. She then notes that “a balance of the gut-lung axis is
critical to clearance and response to Influenza.” Id. It is not clear whether she was
referring to an influenza virus or influenza vaccine.
Ms. Mikovits opines that administrations of influenza vaccine prior to the
September 2010 administration were responsible for Ms. McCabe’s preexisting
history of depression, fatigue, and insomnia. Id. She notes, without support, that
each of these three disorders is “firmly associated with elevated levels of the pro-
inflammatory cytokines like IL6 and the development of serious even fatal
anaphylactic reactions even after several course[s] of treatment with the immune
therapy.” Id. Ms. Mikovits’ references to anaphylactic reactions appears
misplaced as no evidence of anaphylaxis appears in Ms. McCabe’s medical
records.
Ms. Mikovits then asserts that Ms. McCabe was always ill and should not
therefore have been vaccinated when ill. Id. However, Ms. Mikovits provides no
support or logical basis for this assertion. She continues: “The diagnoses of
chronic multi-cystic thyroiditis and COPD showed that she was predisposed
toward autoimmunity making rapid timing for cumulative autoimmune reactivity
more likely in 2010.” Id. Ms. Mikovits goes on to argue that Ms. McCabe
suffered injuries after each vaccination, noting that “immediate reactivity (e.g.
hives, eczema, angioedema [and] wheezing) occur rarely after influenza
vaccination (all types), but occurred in every instance of Ms. McCabe’s flu
vaccinations since 2007.” Id. at 4-5. However, the bases for Ms. Mikovits’
assertions are not provided. She goes on to note that Ms. McCabe’s reactions got

24
“cumulatively worse leading to anaphylaxis-like reaction.” Id. at 5. It is not clear
in what way Ms. McCabe’s reactions to the vaccine were anaphylactic or
“anaphylaxis-like.” It is also not clear what “anaphylaxis-like” means. Ms.
Mikovits’ willingness to offer a diagnosis not in the record is troubling given that
she is not medically qualified.
Ms. Mikovits states that Ms. McCabe “had an immediate and sustained
reaction developing coughing and wheezing by January 6, 2007 indicating a
dysregulation of the lung microbiome and vasculitis and small airway disease.” Id.
She continues to say that all these symptoms are consistent with “damage of gut-
lung microbiome and immunotherapy / vaccine-induced cytokine release
syndrome.” Id. Ms. Mikovits does not distinguish symptoms that pre-existed the
vaccination from symptoms Ms. Mikovits is associating with cytokine release
syndrome. As Ms. McCabe testified, she had experienced the chronic cough since
her youth. Tr. 24. It is not clear if Ms. Mikovits was aware of this fact.
Furthermore, Ms. Mikovits does not provide any scholarship to support the concept
of “vaccine-induced cytokine release syndrome.” See exhibit 40 at 5.
Ms. Mikovits proceeds to claim that Ms. McCabe’s symptoms throughout
the summer of 2007 constituted a “worsening of inflammatory / autoimmune
symptoms and evidence of lymphatic dysregulation.” Id. Again, this claim is
given little weight because Ms. Mikovits has not identified any doctor who
diagnosed Ms. McCabe with “lymphatic dysregulation.” Moreover, Ms. Mikovits
has not explained why she is qualified to come up with this diagnosis on her own.
In any event, Ms. Mikovits reviews Ms. McCabe’s symptoms from 2007 to 2010,
remarking along the way that “considering the multi-focal inflammatory sequelae
and disease symptoms, it was medically inadvisable to give her an influenza
vaccine on September 11, 2010.” Id. Again, Ms. Mikovits seems to be straying
from her area of expertise when she offers not only medical conclusions, but also
questions the actions of treating physicians.
After reviewing Ms. McCabe’s medial history, Ms. Mikovits returns to
summarize that “[i]t is our contention these previous vaccines were not without
injury primarily encephalopathy (brain inflammation) as well as gut/urinary tract
issues and respiratory tract issues.” Id. at 6. Ms. Mikovits did not identify any
records showing when Ms. McCabe experienced brain inflammation. In the
absence of a medical doctor’s diagnosis of brain inflammation, it is not clear what
factual basis or qualifications Ms. Mikovits has to make this diagnosis.
Ms. Mikovits then summarizes Ms. McCabe’s symptoms following the
administration of the vaccine and noted that “all of these symptoms are consistent

25
with Cytokine Release Syndrome (CRS) and damage mediated by cytokines
including IL-6.” Id. She goes on to state that the symptoms “can be the result of
cumulative autoimmunity resulting from molecular mimicry of tetra and
pentapeptides cross reacting with self-proteins, including myelin basic protein as
recently detailed with H5N1 influenza vaccine.” Id. To support this proposition
she cites D. Kanduc, Peptide Cross-Reactivity: The Original Sin of Vaccines, 4
Frontiers Biosciences 1393 (2012).11
Listing more symptoms (lightheadedness, decreased appetite, wooziness,
sluggishness, and intermittent headache), Ms. Mikovits concludes that these
clinical symptoms are “consistent with CRS and hypothalamic neurodegeneration
mediated by changes in the gut microbiome and aberrant trafficking of innate
immune cells to the CNS via brain lymphatics and a leaky blood brain barrier.”
Exhibit 40 at 6. Again, Ms. Mikovits has identified no medical doctor to
corroborate her opinion that Ms. McCabe suffered from “hypothalamic
neurodegeneration.”
Ms. Mikovits also reviews the opinion presented by the emergency room
physician, Dr. Boes. Dr. Boes had concluded Ms. McCabe’s “presentation is not
suggestive of acute neurological issue but instead consistent with viral syndrome or
noninfectious inflammation associated in response to the vaccine.” Id. (citing
exhibit 2 at 6). Ms. Mikovits points out that “[b]y definition, this is a vaccine
injury as non-infectious inflammation of the brain is the definition of
encephalopathy.” Exhibit 40 at 7.
Ms. Mikovits proceeds to rebut the physician’s claim that Ms. McCabe did
not have an acute neurological condition by stating that this conclusion was
“refuted just two days later by an MRI” which showed three punctate
hyperintensities in right frontal matter. Id. While Dr. Herbstein, the neurologist
that ordered the MRI, concluded that the findings were “nonspecific” for “multiple
etiologies,” exhibit 1 at 100, Ms. Mikovits uses the hyperintensities and the results
of Ms. McCabe’s October 2010 EEG to conclude that Ms. McCabe suffered from
“vaccine-causing brain pathology, even if it was not an obvious acute
encephalopathy.” Exhibit 40 at 7. To be sure, Ms. Mikovits is challenging the
medical diagnosis of Dr. Boes, the emergency department physician, by
disagreeing with the interpretation of Ms. McCabe’s EEG and MRI made by Dr.
Herbstein, Ms. McCabe’s treating neurologist. She does all this without ever even
seeing the EEG or MRI that formed the basis for Dr. Herbstein’s diagnosis.

11
Petitioner did not file this article into the record.
26
Ms. Mikovits then reviews Ms. McCabe’s various symptoms through the
month of October 2010. Id. Specifically, she references acute sinusitis and
bronchitis, reports of memory loss, unsteadiness, weakness, numbness, and bone
pains. Id. Ms. Mikovits states, again without support, that all are consistent with
cytokine release syndrome and overexpression of IL-6. Id. She then states that
Ms. McCabe’s treatment with prednisone supports a diagnosis of CRS. Id.
However, this logic does not seem to follow since Ms. Mikovits is attempting to
infer the diagnosis based on the prescription and not on the actual diagnosis Ms.
McCabe was given. No evidence in the record indicates that the physicians
prescribed prednisone to treat CRS as opposed to other inflammatory conditions
Ms. McCabe was experiencing.
Ms. Mikovits notes that Ms. McCabe’s symptoms continued into 2011 and
criticizes her physicians for not having performed testing that would demonstrate
that Ms. McCabe had myalgic encephalomyelitis (ME), chronic regional pain
syndrome (CRPS), or fibromyalgia (FM). Exhibit 40 at 7.
Ms. Mikovits then states that “recent publications concerning molecular
mimicry following influenza vaccine and brain lymphatics are critical to the
progressive encephalopathy and hypothalamic brain degeneration and peripheral
neuropathy experienced by Ms. McCabe after each influenza vaccine since 2007
with the final blow being the Flu vaccine of 2010.” Id. at 8. Ms. Mikovits did not
identify any record in which a medical doctor diagnosed Ms. McCabe as suffering
from encephalopathy or hypothalamic brain degeneration. So, it appears that Ms.
Mikovits is diagnosing these conditions. It is not clear what factual bases support
this conclusion and it is concerning to the undersigned that Ms. Mikovits is, again,
diagnosing Ms. McCabe’s condition without sufficient expertise to do so.
Ms. Mikovits states that the 2010 Sanofi flu vaccine contained a “new B
antigen” and associates this B antigen with the development of narcolepsy through
molecular mimicry. Id. at 8. Ms. Mikovits does not explain the relevance of
narcolepsy in Ms. McCabe’s case. Ms. Mikovits then concludes “thus, because of
her immune compromised state at the time of inoculation, novel molecular
mimicry and cross reactive epitopes could have resulted in the anaphylactic
response with the symptoms occurring within hours.” Id. Again, it is not clear
what in the record Ms. Mikovits is referring to in relation to this “anaphylactic
response.”

27
Ms. Mikovits concludes that:
Ms. McCabe’s history of abdominal complaints, nausea and vomiting,
gastric reflux, diverticulosis, and urinary tract infections preceding
and following each flu vaccination had cumulative effects that
allowed rapid brain injury occurrence after six hours in contrast to Dr.
Leist’s assertion to the contrary. These chronic GI symptoms had
already altered the blood brain barrier so that rapid microglia
activation released cytokines and chemokines as well as an influx of
inflammatory stimuli. There are many examples of fatigue and
cerebral dysfunction caused by these stimuli. Thus, a chronic
multistep process over years of vaccination predisposed Ms. McCabe
to rapid adverse events following Sept 11, 2010 vaccination.
Id. As with the previous eight pages of her report, Ms. Mikovits provides no
support from either the literature or the record for the claims she presents.
In evaluating the contents of this report, and Ms. Mikovits’ subsequent ones,
the undersigned remains very concerned by Ms. Mikovits’ provision of opinions
outside her field of expertise. By offering diagnoses unsupported by a treating
medical doctor, Ms. Mikovits not only muddies the waters by interjecting into the
record statements that should not be given the weight of expert opinion, but she
also undermines the credibility of all her statements. When experts are asked
questions outside their area of expertise, the expert should decline to answer. If
experts are willing to speak to anything, regardless of their qualifications or
knowledge, it is difficult to know where the reliable testimony ends and the
guesswork begins.
Respondent filed a responsive report by Dr. Whitton on October 5, 2016.
Exhibit C.
2. Dr. Whitton’s Background and First Report
Dr. Whitton’s Qualifications
Dr. J. Lindsay Whitton is a research scientist specializing in immunology at
the Scripps Research Institute in La Jolla, CA. He earned his undergraduate
degree, medical degree, and Ph.D. from the University of Glasgow. He now serves
as a professor in the Department of Immunology. While medically trained, he does
not practice medicine.

28
Dr. Whitton’s First Report (Exhibit C)
Dr. Whitton begins his report by rebutting Dr. Axelrod’s two reports.
Because, after a change in counsel, Ms. McCabe did not proceed with Dr.
Axelrod’s opinion, Dr. Whitton’s criticisms need not be reviewed in depth.
Nonetheless, it is important to note that Dr. Whitton, over the course of six pages,
identified many places where Dr. Axelrod made statements that either
misconstrued or had no basis at all in the literature that he had cited. See generally
exhibit C at 2-7. Ms. McCabe did not obtain a response from Dr. Axelrod, leaving
Dr. Whitton’s critiques unrebutted. Any reliance on Dr. Axelrod’s written report
is, at best, questionable.
Dr. Whitton then addresses Ms. Mikovits’ report, exhibit 40. Dr. Whitton
begins challenging some of Ms. Mikovits’ credentials. Dr. Whitton noted that Ms.
Mikovits co-authored a 2009 paper that was published in the journal Science.
Exhibit C at 8. This paper associated XMRV, a virus, with CFS. Id. Dr. Whitton
notes that this paper has been subsequently refuted and retracted. Id. Citing her
previous stance on the link between vaccination and autism, Dr. Whitton then
accuses Ms. Mikovits of having an established bias against vaccinations. Id.
Specifically, Dr. Whitton references Ms. Mikovits’ previous claim that “a ton of
data” links the two. Id. (citing Dr. Judy Mikovits Condemns Vaccines, Confirms
Role in Autism, VAXXTER (Feb. 28, 2016), http://vaxxter.com/dr-judy-mikovits.12)
Dr. Whitton addresses the substantive aspects of Dr. Mikovits’ reports.
Preliminarily, Dr. Whitton states confusion about the initial statements Ms.
Mikovits made linking checkpoint inhibitors and Rituxan to adverse events
associated with vaccines. Dr. Whitton notes that the flu vaccine is neither a
checkpoint inhibitor nor a drug similar to Rituxan. Id. at 9.
Dr. Whitton then summarizes Ms. Mikovits’ argument as saying that
multiple influenza vaccines over the course of many years were responsible for
Ms. McCabe being “always ill.” Id. (referencing exhibit 40 at 4). Dr. Whitton
further summarizes Ms. Mikovits’ argument as postulating that the September 11,
2010 flu vaccine was the “final straw, tipping her into florid disease.” Exhibit C at
9. Dr. Whitton draws on Ms. Mikovits’ reference to IL-6 to infer that she believes
that Ms. McCabe’s IL-6 levels were chronically high, leading to her chronic
illnesses. Id. Based on this understanding of Ms. Mikovits’ theory of the case, Dr.
Whitton then concisely states the basis for his disagreement with Ms. Mikovits’
theory: “vaccine-induced cytokine responses are both limited and short-lived.

12
Respondent did not file this article into the record.
29
There are no data that indicate that a vaccine can trigger long-term cytokine
production in vivo.” Id. at 9. He states that his opinion that cytokine responses are
not known to behave in such a way is not due to a lack of research in this field but
because cytokines responding in such a manner would “run contrary to everything
that we know about the immune system.” Id.
Dr. Whitton criticizes Ms. Mikovits for making statements regarding Ms.
McCabe’s diagnoses and medical care that she is not qualified to make and that are
wrong. Id. First, Dr. Whitton states that, as a medically-qualified individual, he
disagrees with Ms. Mikovits’ statement that giving Ms. McCabe a flu vaccine was
inadvisable. Id. Further, he states that Ms. Mikovits’ statement that “non-
infectious inflammation of the brain is the definition of encephalopathy” is
“absolutely incorrect.” Id. (citing exhibit 40 at 7).
Dr. Whitton then criticizes Ms. Mikovits’ interpretation of the MRI Ms.
McCabe received on September 24, 2010. Exhibit C at 10. He states that Ms.
Mikovits is not qualified to challenge the treating physician’s diagnosis and that
nothing in the MRI, contrary to Ms. Mikovits’ claim, links Ms. McCabe’s MRI
findings to the vaccine. Id.
Dr. Whitton similarly criticizes Ms. Mikovits for her diagnosis of CRS
based on the symptoms that Ms. McCabe presented to Dr. Herbstein. Id. He states
that her willingness to criticize the treating physicians is not appropriate given her
lack of credentials, and further states that testing that Ms. Mikovits said would be
definitive (i.e., tests for C-reactive protein (CRP) and erythrocyte sedimentation
rates (ESR)) are non-specific and cannot provide a definitive diagnosis. Id. He
further notes that Ms. McCabe actually was tested for ESR in March 2009 and that
the results were normal. Id. (citing exhibit 1 at 76). Finally, Dr. Whitton criticizes
Ms. Mikovits for censuring Dr. Forster for not performing tests that could have
diagnosed CFS. Exhibit C at 10-11. Again, Dr. Whitton states that Ms. Mikovits
is in no position to make such a criticism and that Ms. Mikovits is mistaken in
saying that there exists a definitive test for CFS. Id. at 11.
In the next part of his report, Dr. Whitton states that Ms. Mikovits repeatedly
conflates temporal proximity with correlation. Id. He also accuses Ms. Mikovits
of overlooking relevant evidence to support a preconceived theory of vaccine
causation. Id. Specifically, Dr. Whitton states that Ms. Mikovits’ attempts to
connect the flu vaccine to rapid brain injury, vomiting, gastric reflux,
diverticulosis, and urinary tract infections are based purely on speculation because
no “established scientific fact” supports a connection. Id. Further, he criticizes
Ms. Mikovits for not mentioning evidence that Ms. McCabe demonstrated these

30
symptoms not only following administration of the vaccine, but in the months
preceding the annual flu vaccinations. Id.
In the final section of his analysis, Dr. Whitton argues that Ms. Mikovits
failed to provide any mechanism by which the flu vaccines could actually cause all
of Ms. McCabe’s symptoms. Id. at 11-12. He again states that Ms. Mikovits
failed to cite any evidence that the flu vaccine could cause prolonged cytokine
responses. Id. at 12. Furthermore, he questions Ms. Mikovits’ basis for saying that
Ms. McCabe suffered an anaphylactic reaction. Id. He notes that petitioner’s other
expert, Dr. Axelrod, who is actually a licensed immunologist, never referenced an
anaphylactic reaction. Id. Dr. Whitton similarly questions Ms. Mikovits’ assertion
that molecular mimicry is involved and states that Ms. Mikovits failed to provide
any mechanistic basis for a molecular mimicry explanation linking the vaccine and
the injury. Id.
Dr. Whitton then identifies a number of material errors in Ms. Mikovits’
report. Id. He points out that a figure cited in Ms. Mikovits report, reproduced at
exhibit 40 at 4, does not actually appear in the paper she referenced. Id. at 12. He
further notes that Ms. Mikovits completely misstates the contents of one of her
submitted articles when she states that the article “shows recent data on lung
pathology in response to flu vaccines.” Id. (citing exhibit 40 at 9). Dr. Whitton
points out that the article does not mention the word “lung” or “pathology.”
Exhibit C at 12. Finally, he notes that Ms. Mikovits’ report had 12 references
provided, but actually referenced only six of them in the text of the report. Id.
A status conference was held on October 21, 2016. During the status
conference, the respondent requested that the petitioner again amend her petition
so as to define petitioner’s injury in a manner consistent with the claims made in
her expert reports. Order, issued Oct. 24, 2016. Respondent also requested, again,
a copy of Ms. McCabe’s MRI films. Id. Finally, the parties discussed holding a
hearing in late 2017. Id.
Ms. McCabe filed a status report stating that she would like to file an expert
report responding to Dr. Whitton’s report. Pet’r’s Status Rep., filed Nov. 21, 2016.
Ms. McCabe also requested until January 9, 2017, to amend her petition. Id. Ms.
McCabe was given until that date to file both her amended petition and the
responsive expert report. Order, issued Nov. 22, 2016.

31
3. Concerns Raised on December 19, 2016
The undersigned warned Ms. McCabe about deficiencies in her case in an
order issued on December 19, 2016. The undersigned specifically raised the issue
that Ms. Mikovits was diagnosing medical conditions when she was not qualified
or licensed as a medical doctor. Order at 1. The undersigned also noted that Ms.
McCabe had not produced any evidence supporting a diagnosis of a demyelinating
condition and thus raised the concern that she could not proceed under the
demyelination theory proffered in her petition. Id. Ms. McCabe was reminded
that under Broekelschen v. Sec’y of Health & Human Servs., she must establish
that she suffers from a particular injury or condition. Id. at 2 (citing 618 F.3d
1339, 1346 (Fed. Cir. 2010)). After raising these concerns, an entitlement hearing
was tentatively set for October 18-20, 2017. Order at 2. Ms. McCabe was
reminded to file her expert report and amended petition by January 9, 2017. Id.
C. Petitioner’s Third Theory – Chronic Fatigue Syndrome
On January 9, 2017, Ms. McCabe moved for an extension of time, until
March 31, 2017, to file her expert report and amended petition. While Ms.
McCabe was able to file a report from Ms. Mikovits on January 9, 2017, she stated
that she was unable to find a medical doctor who is an expert in ME/CFS. Exhibit
58; Pet’r’s Mot., filed Jan. 9, 2017, at 1. The undersigned deferred ruling on
petitioner’s motion until after a status conference to be held on February 7, 2017.
Order, issued Jan. 10, 2017. During the status conference, Ms. McCabe reported
that she had identified a suitable expert. Order, issued Feb. 7, 2017. The
undersigned then granted Ms. McCabe’s motion for an extension of time to file her
amended petition and expert report from a medical expert in ME/CFS, giving Ms.
McCabe until April 17, 2017 to file both. Id.
1. Ms. Mikovits’ Second Report (Exhibit 58)
In the first two and a half pages of Ms. Mikovits’ second report, Ms.
Mikovits primarily focused on rehabilitating her background. Exhibit 58 at 1-3.
She notes her history of work in immune therapy in the 1980s and the contribution
of her work to contemporary medicine. Id. at 2. She then details her more recent
work on neuroimmune disorders. Id. She discusses her 2009 paper on the
presence of XMRV in patients with ME/CFS. Id. She defends the paper, noting
that the “retraction of the Science paper was political and not scientific.” Id. She
further notes that a 2010 paper published in the Proceedings of the National
Academy of Sciences confirmed and extended the results published in the retracted
2009 article. Id. at 3 (referencing exhibit N1 (Shyh-Ching Lo et al., Detection of

32
MLV-related Virus Gene Sequences in Blood of Patients with Chronic Fatigue
Syndrome and Healthy Blood Donors, 107 Proc. Nat’l. Acad. Sci. 15874 (2010)13).
Returning to the McCabe matter, Ms. Mikovits defends her use of
checkpoint inhibitors and monoclonal antibody therapy as informative in a case
involving an influenza vaccination. Exhibit 58 at 2. She states that the toxicities
involved in these cases involve overstimulation of the same processes that are
involved in a flu vaccination and thus are informative. Id.
Ms. Mikovits then restates her theory, saying that her theory was that the
September 11, 2010 influenza vaccination significantly exacerbated the active
preexisting inflammatory disease. Id. This worsening was through over activation
and dysregulation of cytokines, chemokines, and inflammatory mediators. Id.
With respect to cytokines, etc., Ms. Mikovits states: “The clinical data clearly
support our theory, and that is found in the report of Dr. Axelrod, which stated that
adjuvants and excipients can cause synergistic immune activation or aberrant
inflammatory function of innate immune cells, including but not limited to:
dendritic cells, macrophages and mast cells.” Id. at 3. Although Ms. Mikovits was
aware of Dr. Whitton’s criticisms of Dr. Axelrod’s report, Ms. Mikovits did not
answer any of Dr. Whitton’s criticisms. She appears to accept Dr. Axelrod’s
opinion without any independent analysis.
Responding to Dr. Whitton’s criticism of Ms. Mikovits’ willingness to make
medical diagnoses and criticize the treating physicians, she states that she “did not
interpret any clinical data.” Id. at 4. Ms. Mikovits’ statement about her lack of
interpretation appears, to the undersigned, to be patently false.
Ms. Mikovits then addresses Dr. Whitton’s criticism that Ms. Mikovits’
theory failed to address how a flu vaccine could cause a long-term cytokine
production in vivo. Id. She states that smallpox vaccination was shown to result in
persistent long-term inflammation. Id.
Ms. Mikovits also notes that the ingredients in the flu vaccine “can and have
been shown to contribute to systemic aberrant immune responses through
overactive inflammatory mediators and persistence of dysfunctional immune cell
subsets.” Id. Although Ms. Mikovits uses the phrase “have been shown,” Ms.
Mikovits did not cite any articles where this was in fact shown.

13
While petitioner did not file this exhibit, respondent did. This decision references
respondent’s exhibit.
33
Ms. Mikovits acknowledges that she incorrectly stated that encephalopathy
was non-infectious inflammation of the brain and provided a revised definition. Id.
at 5. She stated that Ms. McCabe “had many of the symptoms of myalgic
encephalomyelitis within weeks of the September 11, 2012 [sic] influenza
vaccination.” Id. Ms. Mikovits, again, fails to identify the symptoms to which she
is referring. She then states that “[Ms. McCabe] had risk factors and symptoms of
both encephalitis and ME but never had a diagnosis of either. What we were
actually referring to is known as secondary (post-infectious) encephalitis which is
an aberrant immune system reaction that can be caused by vaccinations.” Id. No
support is provided for Ms. Mikovits’ claim that Ms. McCabe had risk factors and
symptoms of encephalitis and no reference is provided for Ms. Mikovits’ claim
that secondary (post-infectious) encephalitis is an aberrant immune system reaction
that can be caused by vaccination. See id. at 5.
Ms. Mikovits then criticizes Dr. Whitton’s assessment of the significance of
the MRI results. Id. at 5. She states that several papers in the literature link
influenza vaccination to a “spectrum of CNS damage including demyelination.”
Id. She cites “Ussel et al., Will et al., and Kim et al.” Id. Ms. Mikovits did not
provide any additional details (e.g., article title, journal name, publication year)
about the papers named. Moreover Ms. McCabe did not enter any of these papers
into the record. Thus, the accuracy of Ms. Mikovits’ assertion cannot be evaluated.
Ms. McCabe filed her amended petition on April 17, 2017. On that same
date she filed an expert report from her new expert, Dr. Levine. Exhibit 59.
2. Dr. Levine’s Background and First Report
Dr. Levine’s Qualifications
Dr. Susan Levine is a physician specializing in internal medicine and
infectious diseases. She earned her undergraduate degree from Hunter College and
medical degree from the Albert Einstein College of Medicine. She has been in
private practice for 28 years. She has participated in clinical research studies
looking at the mechanisms of CFS. She has served as chair of a Federal Advisory
Committee on CFS.
Dr. Levine’s First Report (Exhibit 59)
Dr. Levine begins her report by stating that Ms. McCabe had experienced
“low level symptoms” of CFS following the receipt of the flu vaccine on several
occasions prior to the flu vaccine in question. Exhibit 59 at 2. To demonstrate
this, Dr. Levine states the following:

34
On 1/6/07 following receipt of the influenza vaccine on 10/2/06 she
reports symptoms of insomnia and is being treated with zolpidem, in
addition to Effexor. In February of 2007 she reports wheezing and a
small nodule is reported on Chest X-ray. After that, on 5/12/07, she is
treated with depomedrol for a ‘cough.’ On 5/21/08, she is again
evaluated for a ‘cough.’ The occurrence of allergic symptoms of
which this patient’s cough is a manifestation (most likely post nasal
drip combined with bronchospasm) has been found to predate the
actual onset of CFS. She continues to report low level symptoms of
anxiety and insomnia and is once again administered a flu vaccine on
10/19/08. On 12/8/08 an endoscopy reveals ‘reactive gastritis’ of the
antral mucosa. On 10/27/09 she reports ‘gastritis’ another symptom
that has been found to predate the onset of CFS symptoms in a cohort
of these patients.
Id.
Dr. Levine does not note that Ms. McCabe was experiencing symptoms of
insomnia in the past, as established since her very first medical record filed herein.
See exhibit 1 at 1. This is also true for Ms. McCabe’s cough, which Ms. McCabe
had since she was a child. Tr. 24. Dr. Levine also fails to mention the myriad of
other symptoms that Ms. McCabe presented throughout the years covered by the
records.
Dr. Levine then reviews her proposed mechanism of action linking the
vaccine and Ms. McCabe’s “adverse reaction”. Exhibit 59 at 2-3. She states:
Dr. Axelrod has reviewed the mechanism thought to underlie the
immune response in most human subjects following the receipt of
influenza vaccine. He describes the release of pro-inflammatory
mediators, including IL-6 which proceed to increase permeability of
the blood brain barrier and which result in the various neurological
manifestations observed.
Id. at 3. Dr. Levine, like Ms. Mikovits, thus appears to adopt Dr. Axelrod’s
mechanism of action wholesale, with no attempt to address the numerous
criticisms raised by Dr. Whitton.
Consistent with the IL-6 mediated theory adopted from Dr. Axelrod, Dr.
Levine notes that IL-6 levels are elevated in senescence and that they may thus
play a role in promoting aberrant responses in those at Ms. McCabe’s stage of life.
Id. To support this proposition, Dr. Levine cites exhibit 65 (Nathaniel D. Lambert
35
et al., Understanding the Immune Response to Seasonal Influenza Vaccination in
Older Adults: A Systems Biology Approach, 11 Expert Review Vaccines 985
(2012)).
Dr. Levine then proposes a “kindling” model for the etiology of Ms.
McCabe’s CFS. Exhibit 59 at 3. She states that this theory proposes that repeated
exposure to an initially sub-threshold stimulus can eventually result in a
suprathreshold response, manifesting as “spontaneous seizure like activity.” Id.
Why Dr. Levine references “seizure like activity” is not readily apparent since
seizures do not appear in the record.
Dr. Levine proceeds to state that infectious agents (both live viruses and
vaccines) can “influence secretion of Adrenocorticotropic hormone (ACTH) in the
brain.” Id. Dr. Levine does not provide support for this proposition, however.
She continues to state that this can ultimately lead to “lowered plasma levels of
cortisol” which accounts for the fatigue, insomnia, and adverse response to stress
seen in CFS patients. Id. For this line of logic, Dr. Levine cites exhibit 66
(Leonard A. Jason et al., An Etiological Model for Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome, 2 Neuroscience and Medicine 14
(2011)).
Dr. Levine proceeds by noting that “immunization of humans with vaccines
of many types, including MMR, pneumovax, hepatitis B, tetanus, typhoid and
polio, as well as anthrax have been implicated in the development of CFS.”
Exhibit 59 at 3. In support of this proposition, Dr. Levine cites exhibit 68 (L.D.
Devanur & J.R. Kerr, Chronic Fatigue Syndrome, 37 J. Clinical Virology 139
(2006)).
To further support the link between vaccines and CFS, Dr. Levine cites an
article presenting a case study of a young woman who developed POTS with
chronic fatigue two months following her vaccination with human papillomavirus
vaccine. Exhibit 59 at 3 (citing exhibit 69 (Lucija Tomljenovic et al., Postural
Orthostatic Tachycardia With Chronic Fatigue After HPV Vaccination as Part of
the “Autoimmune/Auto-inflammatory Syndrome Induced by Adjuvants”, 2 J.
Investigative Medicine High Impact Case Reports 2324709614527812 (2014)). In
a similar vein, she states that there has been a link between the Pandemrix flu
vaccine and narcolepsy. Exhibit 59 at 4. She cites two articles in support of this
proposition: exhibit 70 (A. Nellore & T. Randall, Narcolepsy and Influenza
Vaccination-The Inappropriate Awakening of Immunity, 4 Annual Translational
Medicine S29 (2016)) and exhibit 71 (A. Sohail Ahmed & Lawrence Steinman,
Narcolepsy and Influenza Vaccination-induced Autoimmunity, 5 Annual

36
Translational Medicine 25 (2017)). Dr. Levine refers to the case of Pandemrix as a
“related clinical model of neurological dysfunction” that is a “plausible mechanism
to explain the course of this patient’s illness.” Exhibit 59 at 4.
Dr. Levine summarizes her opinion: that Ms. McCabe’s “repeated
exposures” to the flu vaccine in conjunction with her premorbid symptoms
(gastrointestinal, allergic, and neuropsychological) facilitated the 2010 flu vaccine
“catapult[ing]” her into a diagnosis of CFS. Id.
3. Concerns Raised on April 20, 2017.
The undersigned reviewed Dr. Levine’s report in conjunction with the newly
filed petition and identified numerous issues in the report that Ms. McCabe would
need to address. See order, issued April 20, 2017. For one, Dr. Levine failed to
state the diagnostic criteria she was using to diagnose Ms. McCabe with CFS and
what the basis in the record was for this diagnosis. Id. at 1. In addition, Dr. Levine
failed to provide adequate support for the following five items in her report: 1) The
link between IL-6 and CFS and why IL-6 is important in this case; 2) The basis for
her “kindling” theory; 3) The link between ACTH and the influenza vaccine, and
its importance to this case; 4) The link between oxidative stress, the flu vaccine,
and CFS, and its importance to this case; and 5) The importance of the HPV-POTS
case study she cites to Ms. McCabe’s case. Id. at 1-2. The undersigned also stated
that Dr. Levine’s report failed to provide any opinion regarding the appropriate
timing between the flu vaccine and the onset of Ms. McCabe’s putative CFS. Id. at
2-3.
With regard to the amended petition, the undersigned sought to confirm that
Ms. McCabe was not proceeding with either the theory that the flu vaccine caused
her to develop or significantly aggravate a demyelinating condition (as Dr. Axelrod
suggested) or the theory that the flu vaccine caused cytokine release syndrome (as
Ms. Mikovits suggested). Id. at 3. Ms. McCabe was given until May 12, 2017 to
file a supplemental report from Dr. Levine. Id. at 4. Ms. McCabe timely filed the
supplemental report on May 12, 2017. Exhibit 72.
4. Dr. Levine’s Supplement to her First Report (Exhibit 72)
Dr. Levine attempts to address the concerns raised in the April 20, 2017
order. With respect to the diagnosis of CFS, Dr. Levine cites a number of Ms.
McCabe’s symptoms in the years prior to and following the 2010 vaccination and
then concludes that “the complaints reported by the patient in the above Exhibits
match the symptoms and exclusionary criteria contained in the case definitions
provided in References 1 and 2.” Exhibit 72 at 1-2. References 1 and 2 are exhibit
37
61 (Leonard A. Jason et al., Data Mining: Comparing the Empiric CFS to the
Canadian ME/CFS Case Definition, 68 J. Clinical Psychology 41 (2012)) and
exhibit 62 (B.M. Carruthers et al., Myalgic Encephalomyelitis: International
Consensus Criteria, 270 J. Internal Medicine 327 (2011)).
Dr. Levine then expands on her claim that the influenza vaccination can
result in the “release of a major pro-inflammatory cytokine, IL-6.” Exhibit 72 at 2.
She states that a number of links between IL-6 and actual influenza viral infection
are “well established” and states that the same is “presumably” true for influenza
vaccine. Id. However, she provides no basis for why a live infection would cause
the same response as the response to an inert substance. She further notes that
mice lacking IL-6 are not able to respond to viral infections properly. Id. at 2-3
citing exhibit 73 (Sarah N. Lauder et al., Interleukin-6 Limits Influenza-induced
Inflammation and Protects Against Fatal Lung Pathology, 43 European J.
Immunology 2613 (2014)).
Dr. Levine continues, noting that poor sleep quality is associated with
elevated levels of IL-6. Id. at 3. She concludes that this association indicates that
there is a “common pathophysiological mechanism between influenza vaccination
and the pathogenesis of ME/CFS.” The undersigned does not understand how this
premise links to the conclusion she draws. For example, poor sleep quality may
cause an increase in IL-6 or both may be affected by some other biologic process.
To lend additional support to her claim that IL-6 as well as other pro-
inflammatory cytokines have also been implicated in the pathophysiology of
ME/CFS, Dr. Levine cites exhibit 75 (L. Russell et al., Illness Progression In
Chronic Fatigue Syndrome: A Shifting Immune Baseline, 17 BMC Immunology 3
(2016)). Exhibit 72 at 3. She similarly cites to exhibit 76 (Hyong Jin Cho et al.,
Association Of C-Reactive Protein And Interleukin-6 With New-Onset Fatigue In
The Whitehall II Prospective Cohort Study, 43 Psychological Medicine 1 (2013))
to show that “along with C reactive protein, plasma levels of IL-6 were found
elevated in a large scale cohort study that correlated with occurrence of systemic
inflammation with the onset of fatigue.” Exhibit 72 at 3. Dr. Levine concludes her
discussion of the link between IL-6 and CFS by noting that the measurement of
cytokines such as IL-6 is not yet used in clinical settings and that it is not unusual
that Ms. McCabe did not undergo a test for cytokine levels. Id.
Dr. Levine next expands on her “kindling” model of CFS. Id. at 3-4. In
further describing the model, Dr. Levine states that it is a “likely model” for the
pathophysiology of ME/CFS and said it occurs when a subject has repeated
exposure to a subthreshold stimulus. Id. at 3. She states that repeated vaccine

38
administration and co-incident low-level symptoms constituted such a subthreshold
stimulus in Ms. McCabe’s case. Id.
To support this theory, Dr. Levine again cites exhibit 61 (Jason). She stated
that the model puts forth how an “infectious agent like the influenza vaccine” can
affect cortisol secretion. Exhibit 72 at 4 (citing exhibit 61 (Jason)). This, she
argues, can also result in oxidative stress, leading to cognitive dysfunction. Exhibit
72 at 4. Dr. Levine summarizes her kindling model in the case of Ms. McCabe:
Therefore, this theory of ‘kindling’ . . . describes the evolution of this
patient’s symptoms over time as outlined in part by the exhibits above
listing all the symptoms that have been found in studies to PREDATE
the onset of actual ME/CFS, such as insomnia, allergies and gastritis,
until her last influenza vaccine which ‘acts to break the camel’s back’
so to speak and thrusts Ms. McCabe into full blown ME/CFS.
Id.
As evidence of Ms. McCabe’s neurological dysfunction, Dr. Levine
references Dr. Herbstein’s recital of Ms. McCabe’s symptoms. Id. Dr. Levine’s
reliance on Dr. Herbstein is strange since Dr. Herbstein concluded, after actually
examining her, that Ms. McCabe was neurologically normal. See exhibit 6 at 4
(“The patient presents with multiple symptoms and basically a normal neurological
exam”).
Dr. Levine then puts forth exhibit 78 (Ian Hickie et al., Post-Infective and
Chronic Fatigue Syndromes Precipitated by Viral and Non-Viral Pathogens:
Prospective Cohort Study, 333 BMJ 575 (2006)). Exhibit 72 at 4-5. She states
that this article “demonstrates that irrespective of the infectious agent that
‘triggers’ the onset of the symptoms of CFS, there is a reproducible pattern of
illness that occurs in certain susceptible individuals following exposure to such an
agent.” Id. She concludes this line of reasoning by stating that “[t]herefore, HPV
and influenza vaccine can both trigger the symptom complex of ME/CFS in a
vulnerable subject.” Id. at 5. Thus, to Dr. Levine, the case reports linking HPV
vaccine with POTS are relevant to a theory that flu vaccine can cause CFS. Dr.
Levine asserts that “because vaccines induce an immune response similar to
infections, they may also, just like infections, trigger autoimmune diseases.”
Exhibit 72 at 4. Dr. Levine concludes her second report by stating that “two
different theories are plausible in linking the administration of flu vaccine in this
patient and the subsequent onset of ME/CFS.” Id. Unfortunately, her report is not
clear about what these two theories are. She subsequently restates the kindling
theory, identifying some of Ms. McCabe’s medical history and previous flu
39
vaccinations and how these constitute “subliminal” symptoms over a four-year
period. Id. However, her second theory appears to be left unstated.
5. Concerns Raised on May 30, 2017
A status conference was held on May 30, 2017, to discuss Dr. Levine’s
supplemental report. The undersigned noted that Dr. Levine again failed to
identify the appropriate timing for each of her theories linking the vaccine with
Ms. McCabe’s putative CFS. Order, issued June 1, 2017, at 1. Further, Dr. Levine
failed to define what symptoms she attributes to Ms. McCabe’s putative CFS. Id.
Petitioner requested an opportunity to file a supplemental report from Dr. Levine
and the undersigned granted that opportunity. Id. at 1-2. The Secretary was also
ordered to file his responsive reports. Id. at 2. The Secretary noted that he would
be filing a responsive report from Dr. Whitton, and would also be retaining a
rheumatologist to provide an opinion. Id. The Secretary filed Dr. Whitton’s
responsive report on June 27, 2017. Exhibit F.
6. Dr. Whitton’s Responsive Report (Exhibit F)
Dr. Whitton’s second report addressed Ms. Mikovits’ report, exhibit 58.
Generally, Dr. Whitton states that Ms. Mikovits’ second report does not “present
any new, or logical, explanation for why [Ms. Mikovits and Mr. Ruscetti] believe
that the vaccine administered to Ms. McCabe on 9/11/2010 caused harm.” Exhibit
F at 1. Dr. Whitton further states that the second report, like her first, contains
incomplete and incorrect citations while omitting reference to some of the cited
papers. Id.
Dr. Whitton begins his rebuttal by pointing out that Ms. Mikovits failed to
address his point that in the six years since the vaccine, Ms. McCabe has never
been diagnosed with a demyelinating disease. Id. This leads Dr. Whitton to point
out that it is impossible for the vaccine to have caused or aggravated a condition
that Ms. McCabe does not appear to have. Id.
Dr. Whitton then comments on Ms. Mikovits’ defense of her retracted 2009
article. To summarize the previous discussion, Ms. Mikovits claimed that her
article was retracted for political as opposed to scientific purposes. Exhibit 58 at 2.
As support for this claim, Ms. Mikovits stated that a 2010 article published in the
Proceedings of the National Academy of Sciences confirmed the 2009 article’s
findings. Id. (citing exhibit N1 (Lo et al. (2010))). Dr. Whitton states that this
2010 article was also retracted. Exhibit F at 2. The undersigned agrees with Dr.
Whitton that Ms. Mikovits’ citation to two retracted articles without noting either
retraction diminishes her credibility.
40
Dr. Whitton then rebuts Ms. Mikovits’ reference to the smallpox vaccine as
being an example of how a vaccine can result in a prolonged cytokine response.
Exhibit F at 2-3. Dr. Whitton does not disagree that there is a prolonged response
to the smallpox vaccine. Id. at 3. Instead, he points out that the smallpox vaccine
that Ms. Mikovits was referencing was a live-virus vaccine that “replicates quite
well and often causes the formation of a pock that takes some time (7-10 days) to
resolve.” Id. In contrast, he notes, the viral components that make up the
influenza vaccine in question are killed and do not replicate, resulting in “less
marked innate and adaptive immune responses.” Id. In conclusion, Dr. Whitton
states that Ms. Mikovits’ most recent report does not alter his opinion that there is
no evidence to support the conclusion that the flu vaccine can cause, in vivo,
anything more than a “limited and short-lived” cytokine response. Id. at 4-5.
On June 30, 2017, petitioner moved for a two-week extension of time to file
her supplemental report from Dr. Levine. Petitioner’s motion was granted. Order,
issued July 10, 2017. Ms. McCabe timely filed Dr. Levine’s supplemental report
on July 14, 2017. Exhibit 80.
7. Dr. Levine’s Second Supplemental Report (Exhibit 80)
As discussed above, Dr. Levine’s supplemental report was supposed to
respond to the undersigned’s request for clarification on the mechanism Dr. Levine
was proposing to connect the flu vaccine and CFS. Order, issued June 1, 2017.
Dr. Levine was also instructed to opine on the appropriate timing of this proposed
mechanism. Id. Dr. Levine was also ordered to file a clear statement about which
medical records Dr. Levine associated with CFS. Id.
Unfortunately, Dr. Levine’s new report provides little new information. She
states that following her October 2, 2006 flu vaccine, “Ms. McCabe complained of
worse insomnia, a key symptom of ME/CFS, 3 months later.” Exhibit 80 at 1. Dr.
Levine also notes Ms. McCabe’s diagnosis of gastritis two months after her
October 2008 vaccination, which Dr. Levine says is “a notable symptom found in
ME/CFS patients.” Id. Dr. Levine states that these events were kindling to her
“full blown” ME/CFS three days following her September 2010 flu shot. Id. at 2.
Dr. Levine associates this “full blown” ME/CFS with her cognitive complaints
noted on September 14, 2010 as well as the MRI of her brain that noted
demyelinating lesions, which Dr. Levine stated are thought to be autoimmune in
nature. Id. at 1-2.
Dr. Levine asserts that her references to IL-6 are based on research studies
of ME/CFS, although she does not cite any studies. Id. at 1. She states that we do
not know about Ms. McCabe’s IL-6 levels because the physicians treating Ms.
41
McCabe did not realize at the time that she was suffering from ME/CFS. Id. Dr.
Levine revisits the case report of a girl who developed POTS after a HPV
vaccination. Id. at 2. Dr. Levine notes that the girl had elevated antinuclear
antibody (ANA) levels two months after receipt of the HPV vaccination. Id. Dr.
Levine states that “we can assume [that the HPV vaccination] can cause an adverse
reaction similar to that of the influenza vaccine.” Id. Beyond a temporal sequence
of events, there does not appear to be support for the claim presented here that the
HPV vaccination caused the elevated levels of ANA.
Dr. Levine concluded her report by stating:
Finally, the occurrence of symptoms associated with ME/CFS within
months of Ms. McCabe's receipt over a five year period, initially
controllable with medication established a pattern of symptoms
outlined in reference 6, which describes 'kindling'. This is a term that
explains the occurrence of some symptoms, such as insomnia or
migraine headaches or allergies in future ME/CFS patients and which
may act as a harbinger for full blown disease. Ms. McCabe developed
symptoms of insomnia treated with zolpidem on 1/6/07 after receipt of
influenza vaccine on 10/2/06 but was able to continue working.
Three days after receipt of influenza vaccine on 9/11/10 she
developed full blown ME/CFS with symptoms of confusion and
significant cognitive dysfunction which completely interfered with her
life. The timing of the onset of her symptoms after vaccinations in
this case is completely appropriate.
Id.
8. Concerns Raised on August 1, 2017
After reviewing Dr. Levine’s most recent submission (exhibit 80), the
undersigned issued an order on August 1, 2017, stating that the hearing may not be
able to proceed as scheduled due to problems with the reports. See order at 1. The
order reviewed the background of the current issue: A December 19, 2016 order
highlighted major issues with petitioner’s case and directed petitioner to clarify
Ms. McCabe’s specific injury and how that injury was linked to the flu vaccine she
received. Id. at 1. Despite over seven months’ time since that order, petitioner had
still failed to present a cogent expert report. The most recent report from Dr.
Levine, the undersigned noted, failed to explain her conclusion that the temporal
relationship between the flu vaccine and petitioner’s symptoms was appropriate.
Id. at 2.
42
Furthermore, based on Dr. Levine’s most recent reports, the undersigned
noted that it appeared that petitioner was pivoting toward a claim of significant
aggravation without providing any evidence demonstrating significant aggravation
compared to a normal progression of CFS. Id. at 3. In conclusion, the undersigned
noted: “[i]n short, from a review of the reports from the petitioner’s experts, it
appears that petitioner’s case may not be complete and may not be coherent.
Petitioner may, with additional work and additional disclosures, put together a
persuasive case. That development should take place before the hearing.” Id. The
order scheduled a status conference on August 17, 2017, to discuss how the
petitioner would like to proceed. Id.
Prior to, and in the days immediately following, the status conference,
respondent filed responsive reports from Dr. Whitton (exhibit G), Dr. Leist (exhibit
J), and a new expert, Dr. Matloubian (exhibit H).
9. Dr. Whitton’s Third Report (Exhibit G)
Dr. Whitton’s third report responds to Dr. Levine’s first three reports
(exhibits 59, 72, and 80).
Dr. Whitton began by criticizing Dr. Levine for adopting Dr. Axelrod’s
assertion that the influenza vaccine could result in sustained production of IL-6,
resulting in the degradation of the blood brain barrier. Exhibit G at 3. Dr. Whitton
states that this unsupported assumption underlies Dr. Levine’s theory and
incorporates his previous rebuttal to this assertion. Id.
Dr. Whitton then addresses Dr. Levine’s kindling theory, linking
subthreshold neurological insults to the development of ME/CFS. Dr. Whitton
states that he is aware of the kindling theory in relation to seizure disorders. Id.
However, he states that he is not aware of any evidence that supports the concept
of kindling in the realm of immunology and ME/CFS specifically. Id. He further
states that Dr. Levine’s report provides no such evidence. Id.
Dr. Whitton next evaluates exhibit 68 (Devanur), which was cited by Dr.
Levine to support her claim that vaccines have been shown to cause CFS. Exhibit
59 at 3. He states that Dr. Levine mischaracterized what the article was reporting.
According to Dr. Whitton, the article was not itself saying that vaccines have been
shown to cause CFS, but that, and he quotes the article, “immunization with
various vaccines have been reported to trigger CFS.” Id. at 3-4 (quoting exhibit 68
(Devanur) at 7). He further notes that the Devanur article based this association on
case reports only, not on experimental studies demonstrating causation. Exhibit G

43
at 3-4. Thus, to cite exhibit 68 (Devanur) as evidence of causation would be vastly
overstating the strength of the evidence. Id.
Following up on the evidence linking the influenza vaccine with CFS, Dr.
Whitton introduces exhibit G2 (Per Magnus et al., Chronic Fatigue Syndrome /
Myalgic Encephalomyelitis (CFS/ME) Is Associated With Pandemic Influenza
Infection, But Not With An Adjuvanted Pandemic Influenza Vaccine, 33 Vaccine
6173 (2015)). This epidemiological study followed the population of Norway
during the H1N1 pandemic and measured onset of CFS in patients who were either
vaccinated with the H1N1 vaccine (Pandemrix) or who (likely) were infected with
the H1N1 virus.14 Vaccination, infection, and diagnosis of CFS was determined
through the Norwegian immunization registry, reimbursement data from primary
care physicians, the Norwegian surveillance system for communicable diseases,
and the national specialists health care register. The study’s authors tracked
individuals from the onset of the peak of the H1N1 pandemic (October 1, 2009)
through either their emigration, death, or the end of the study (December 2012) and
examined the relative hazard ratio (HR) of vaccination, infection, and their
interaction. The major results are reproduced in the table below:

As the table indicates, infection with the H1N1 virus was associated with a twofold
increase in the relative risk of subjects being diagnosed with CFS. However,
vaccination itself was not associated with any change in the relative risk of subjects
being diagnosed with CFS. As the authors conclude: “This suggests that
development of CFS/ME may be a reaction to fever, malaise, and general
activation of the immune system, rather than the more restricted antigenic
stimulation from a vaccine.” Id. at 6175.
Dr. Whitton then comments on Dr. Levine’s second report (exhibit 72). Dr.
Whitton points out that Dr. Levine’s discussion of IL-6 fails to address how the flu

14
The authors presumed that a diagnosis of a “flu-like” illness during the peak pandemic
period reflected a H1N1 infection, but excluded all diagnoses of “flu-like” illness outside of the
peak pandemic period. When antigenic testing was used to diagnose H1N1, the authors did not
exclude cases based on when the diagnosis occurred.
44
vaccine can trigger a large and/or long-term increase in IL-6 levels. Exhibit G at 4.
This criticism relates back to Dr. Whitton’s comments on Dr. Axelrod’s theory and
his criticism that Dr. Levine adopted this theory without independent examination.
Id.
Regarding the kindling theory, Dr. Whitton states that the kindling theory is
only an untested model that “may have value in relation to the [central nervous
system],” since that is the system in which it has been shown, but that in the realm
of immunology it “barely reaches the level of a hypothesis.” Exhibit G at 4-5.
Dr. Whitton then addresses the “seminal” paper that Dr. Levine put forth as
linking the flu vaccine and Ms. McCabe’s CFS. This article was entered as exhibit
78 (Hickie). To recap, Dr. Levine had stated that the article stood for the
conclusion that “HPV and influenza vaccine can both trigger the symptom
complex of ME/CFS.” Exhibit 72 at 5. Dr. Whitton states that he carefully read
the paper and notes “the word vaccine (nor any relative thereof) does not even
appear in the main text.” Exhibit G at 5.
Dr. Whitton’s assessment of the conclusion of Dr. Levine’s second report
was similar to the undersigned’s insomuch as he is also unable to discern what are
the “two different theories” that Dr. Levine says can account for linking Ms.
McCabe’s flu vaccine with her CFS. Id. (commenting on exhibit 72 at 5).
Finally, Dr. Whitton comments on Dr. Levine’s third report (exhibit 80).
Exhibit G at 5-6. The issues Dr. Whitton claims with regard to Dr. Levine’s third
report parallel the issues he raised with regard to reports one and two. Dr. Whitton
states that Dr. Levine did not provide any additional insight on how a flu vaccine
can cause insomnia three months after one administration of flu vaccine and can
cause gastritis two months after another administration. In addition to the lack of
foundation for a claim of causation, Dr. Whitton notes that Ms. McCabe was
experiencing insomnia at the time of the first submitted medical record from
October 2006. Id. at 6 (citing exhibit 1 at 3).

45
10. Dr. Matloubian’s Background and First Report
Dr. Matloubian’s Qualifications
Dr. Mehrdad Matloubian is a physician-scientist specializing in
rheumatology and internal medicine at the University of California San Francisco.
He earned his undergraduate degree, M.D., and Ph.D. from the University of
California Los Angeles. He now serves as an Associate Adjunct Professor with the
University of California San Francisco.
Dr. Matloubian’s First Report (Exhibit H)
Dr. Matloubian begins by reviewing Dr. Levine’s reports. See exhibit H at
2. He stated that Dr. Levine failed to provide any evidence that the influenza
vaccine leads to persistent elevation of IL-6, or any other cytokine following
immunization. Id. He also stated that Dr. Levine consistently treated an influenza
infection and the influenza vaccine as being somehow equivalent. Id. Dr.
Matloubian states that this is “not scientifically correct.” Id. Finally, he noted that
while some evidence shows that CFS may follow an infection, CFS is not
associated with flu infection, much less a flu vaccine. Id.
Dr. Matloubian then presents the 2015 Institute of Medicine (IOM) report on
CFS. Exhibit M1 (IOM, Beyond Myalgic Encephalomyelitis/Chronic Fatigue
Syndrome: Redefining an Illness, Nat’l Acad. Press (2015)). Dr. Matloubian
summarizes the IOM’s major findings and recommendations, beginning with its
proposed diagnostic criteria. See exhibit H at 2-4.
For diagnosis of CFS, the IOM committee recognized that there does not
exist “objective abnormal findings either clinically or through the use of diagnostic
tools that are readily available” and that “the diagnosis depends solely on patient
reported symptoms after other possibilities have been excluded.” Exhibit H at 2.
According to Dr. Matloubian, the IOM committee’s criteria for ME/CFS requires
the presence of at least three symptoms: profound fatigue not relieved by rest, post-
exertional malaise, and unrefreshing sleep. Exhibit H at 2 (citing exhibit M1
(IOM) at 210). The diagnosis further requires either cognitive impairment or
orthostatic intolerance. Id. Dr. Matloubian concludes that Ms. McCabe’s
symptoms do not support the diagnosis of ME/CFS based on the above criteria for
the following reasons: 1) sleep apnea was never addressed as the cause of Ms.
McCabe’s sleep disturbances and chronic fatigue, and 2) Ms. McCabe had no
neurological impairments or orthostatic intolerance. Id. at 2-3.

46
For the etiology of ME/CFS, Dr. Matloubian then reviews what the IOM
said is known about the etiology of ME/CFS. Id. at 3. In short, he states that “all
experts agree that the cause is unknown.” Id. He does note that the IOM panel
states that there is “high quality” data linking the involvement of the immune
system. Id. (citing exhibit M1 (IOM) at 152). However, it is not clear from this
data whether the immune system changes associated with CFS are a cause or effect
of the disease. Id. Furthermore, while the committee did resolve that some parts
of the immune system are known to be dysregulated in CFS patients (e.g., natural
killer cells), it was not able to reach a definite conclusion regarding cytokine
abnormalities and CFS. Id. As with natural killer cells, it is not known if any
cytokine imbalances (to the extent they exist) are a cause or effect of ME/CFS. Id.
Whether there exists a causal link between IL-6, or any other compound, and
CFS appears to be secondary—in this case, at least—to the question of whether the
flu vaccine is associated with dysregulation of these compounds. That is the next
question that Dr. Matloubian addresses. To begin, Dr. Matloubian reviews the
mechanisms of influenza infections and contrasts this process with what occurs
when one receives a flu vaccination. Exhibit H at 4. As reported in the
manufacturer’s statement, the virus is fixed and killed with formaldehyde and then
broken down using a detergent. Id. at 5. The result is a compound that is
incapable of replication. Id. He further notes that Ms. McCabe’s September 2010
flu vaccine, Fluzone, did not contain any adjuvants. Id. at 6. Because of the
characteristics of the killed and broken down vaccine, the remaining proteins do
not “present as a threat to the individual as does the influenza virus, and hence,
do[] not require the same host defense pathways and cytokines for protection.” Id.
Thus, Dr. Matloubian concludes, the pertinent question for this case under
petitioner’s theory is whether the flu vaccine (and not the flu virus) can cause
sustained production of cytokines such as IL-6. Id. He puts forth exhibit M5 (J.P.
Valensi et al., Systemic Cytokine Profiles In BALB/C Mice Immunized With
Trivalent Influenza Vaccine Containing MF59 Oil Emulsion And Other Advanced
Adjuvants, 153 J. Immunology 4029 (1994)). Referencing this article, Dr.
Matloubian states that the authors measured several cytokines in mice serum
starting three hours after vaccination with an inactivated virus. The study was
done with and without the presence of adjuvants. The results, he states, are that
detectable levels of IL-6 were not found even up to 24 hours after vaccination
when the vaccine was not supplemented with an adjuvant. Exhibit H at 6.
Dr. Matloubian also offers exhibit M6 (J.U. McDonald et al., Inflammatory
Responses to Influenza Vaccination at the Extremes of Age, 151 Immunology 451
(2017)). This article, Dr. Matloubian states, examined both young and old mice’s
47
cytokine levels in response to an inactivated influenza vaccine. Exhibit H at 6. Dr.
Matloubian states that the authors found that any cytokine induction was
“transient” and the levels “returned to baseline values usually within 24 hours after
immunization.” Id.
The studies referenced in exhibits M5 and M6 were both done on mice. Dr.
Matloubian also offers exhibit M7 (J.C. Eriksson et al., Local and Systemic
Cytokine and Chemokine Responses after Parenteral Influenza Vaccination, 1
Influenza and Other Respiratory Viruses 139 (2007)). In this article, Dr.
Matloubian states that the authors did not find significant elevation of
inflammatory cytokines in the sera of immunized human subjects one and two
weeks after immunization. Exhibit H at 6.
Dr. Matloubian concludes on the basis of these studies that “it is not clear
how in a biologically plausible manner [a flu vaccine] could lead to sustained
levels of IL-6.” Id. Because Dr. Levine, Ms. Mikovits, and Dr. Axelrod used IL-6
to connect the vaccine to the putative ME/CFS, it is thus not clear, according to Dr.
Matloubian, how the vaccine and the ME/CFS can be connected. Id.
Dr. Matloubian acknowledges that while ME/CFS has been associated with
certain viral infections, influenza virus is not on the “usual list of culprits.” Id. at
7. He cites exhibit M1 (IOM) at 157-62 and exhibit 78 to support this proposition.
Id. According to Dr. Matloubian, the viruses associated with ME/CFS are usually
those that have large genomes with complex replication cycles that result in a
chronic latent infection. Exhibit H at 7-8. Infections with these viruses can result
in a chronic stimulation of the immune system, driving inflammation. Id. at 8. In
contrast, the flu virus is a small genome virus that does not result in a chronic or
latent infection. Id. at 8. Therefore, the virus is much less likely to be a cause of
ME/CFS.15 Id.
Dr. Matloubian then addresses, in great detail, some of the statements made
by Dr. Levine connecting vaccines to autoimmune disorders. First, he addresses
her point that previous associations between the Pandemrix vaccine and narcolepsy
support her argument connecting the Fluzone vaccine with ME/CFS. Id. Dr.
Matloubian rebuts this by saying that the mechanism thought to associate
autoimmunity and narcolepsy—the HLA DQB1*0602 haplotype—is not present in

15
While influenza may be much less likely to cause CFS compared to other infections, in
at least one epidemiological study, exhibit G2 (Magnus), influenza infection (but not
vaccination) was associated with a two-fold increase in the relative risk of a person being
diagnosed with CFS. See Section II.C.9, above.
48
the case of ME/CFS. Id. Second, unlike CFS, narcolepsy has been associated with
infections with the H1N1 virus.16 Id. Third, the cases showing a connection
between the flu vaccine and narcolepsy occurred with only one specific vaccine
preparation, which was adjuvanted. Id. It has not been associated with other
preparations of the flu vaccine. Id. Further, Dr. Matloubian notes that the
connection between the Pandemrix preparation and narcolepsy is, itself, still a
matter of debate. Id.
Dr. Matloubian then addresses the connection that Dr. Levine raised
between the HPV vaccine and POTS. Id. at 8-9. He notes that the woman in
question may have had a pre-existing autoimmune disease, such as lupus. Id. at 9.
He further states that this case study was merely a case study, and provided no
empirical basis for concluding a causal connection exists. Id. Furthermore, the
mechanism proposed in the case study is not applicable to Ms. McCabe’s case
since the HPV vaccine is adjuvanted, unlike the flu vaccine in question here. Id.
Finally, he asserts that the difference in the genetic makeup between HPV and flu
virus makes a hypothetical mechanism based on molecular mimicry “extremely
unlikely.” Id.
In the last portion of his opinion addressing Dr. Levine’s medical theory, Dr.
Matloubian speaks to Dr. Levine’s assertion that “aberrant ACTH secretion
explains in part the mechanism by which the HPA axis can enhance the effect of an
‘infectious agent’ like the influenza vaccine by lowering cortisol levels (via the
HPA axis) and heightening the pro-inflammatory response.” Exhibit H at 9 (citing
exhibit 72 at 4). Dr. Matloubian, again, notes that inactivated flu vaccine is not an
infectious agent and that to label it as one is not correct. Exhibit H at 9. He further
comments that the IOM committee found that there was insufficient evidence to
conclude that any specific neuroendocrine abnormalities cause ME/CFS. Id.
(citing exhibit M1 (IOM) at 157).
Dr. Matloubian next addresses the issue of timing. He states that based on
animal models with non-adjuvanted influenza vaccines, there are no measureable
systemic levels of IL-6 at 3, 6, 12, and 24 hours after immunization. Exhibit H at
9. In addition to the time it takes to produce the cytokines, he noted there is the
delay between their production and any effect they may have on the subject’s
nervous system function. Id. at 9-10. He comments that this timeline is
inconsistent with petitioner’s claim that the symptoms began 6 hours after her
immunization. Id. at 10. Finally, he returns to his earlier observation that cytokine

16
But see footnote 11 and Section II.C.9, above (at least one epidemiological study has
associated CFS with influenza, but not influenza vaccine).
49
responses are “quite low in magnitude and short-lived” and thus would not explain
symptoms that occurred weeks to months later. Id.
11. Dr. Leist’s Supplemental Report (Exhibit J)
Dr.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/4285796. Public record. Not legal advice.