McCabe v. Secretary of Health and Human Services

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. Leist submitted a brief supplemental report on August 23, 2017, which

provided an analysis of the MRI performed on Ms. McCabe on September 24,

2010. Exhibit J. Dr. Leist said that he concurs with the radiologists’ assessment

that the three subcortical white matter hyperintensities were not specific for any

particular pathobiology. Id. at 1. Furthermore, he associates the hyperintensities

with Ms. McCabe’s history of cardiovascular disease (including chest pain,

palpitations, tachycardia, and COPD). Id. To support his assertion that these

cardiovascular conditions are “known to be associated” with cerebral white matter

changes, Dr. Leist cites one article. Exhibit J at 1 (citing exhibit J2 (C.A. Spilling

et al., White Matter Lesions Characterize Brain Involvement In Moderate To

Severe Chronic Obstructive Pulmonary Disease, But Cerebral Atrophy Does Not,

17 BMC Pulmonary Medicine 92 (2017))).

12. Concerns Raised in August 2017 Status Conferences

During an August 17, 2017 status conference, petitioner’s attorney stated

that he was not familiar with the contents of the August 1, 2017 order. Order,

issued Aug. 17, 2017, at 1. He attributed his lack of preparedness to an unexpected

family development. Id. The undersigned conveyed to the petitioner that between

the issues presented in the August 1, 2017 order and the issues identified by Dr.

Whitton’s and Dr. Matloubian’s more recently filed expert reports, there was a

concern that a reasonable basis for proceeding to the hearing did not exist. Id. A

status conference was set for August 30, 2017, to further discuss the issues. Id.

During the August 30, 2017 status conference, petitioner stated that she

intended to proceed with the hearing. Order, issued Aug. 31, 2017, at 1. The

Secretary argued that a hearing was not appropriate because petitioner had failed to

present evidence regarding the appropriate timing for the link between the

vaccination and CFS. Id. In addition, the Secretary argued that no evidence of

significant aggravation had been presented. Id. The undersigned stated his

concern that there were significant gaps in petitioner’s case and urged Ms. McCabe

to address these gaps in her pre-trial brief and final expert statements. Id. at 1-2.

13. Ms. Mikovits’ Final Report (Exhibit 81)

Ms. Mikovits submitted a final report on September 5, 2017. Exhibit 81.

50

In this report Ms. Mikovits states that the status of Ms. McCabe’s health,

particularly with respect to the worsening inflammatory gastrointestinal disease she

suffered in the year prior to the vaccination, resulted in a critical and profound

disruption of the gut microbiota. Id. at 2. The September 11, 2010 vaccination,

because it was given prior to the resolution of this condition, resulted in the

immediate development of severe and life-changing ME/CFS from which she has

not recovered. Id.

Ms. Mikovits comments that at the time of her 2010 vaccination, Ms.

McCabe had been diagnosed with sinusitis, bronchitis, severe gastritis, COPD,

asthma, IBS, diverticulitis, and depression. Id. Ms. Mikovits asserts that these are

“all inflammatory diseases” that are “caused in part by dysregulation of

inflammatory cytokines and chemokines.” Id.

Regarding her diagnosis, Ms. Mikovits notes that at the time of the

September 11, 2010 vaccination, the International Consensus diagnostic criteria for

ME/CFS had not yet been published. Id. She then states that the “most rigorous”

criteria at the time was the Canadian Consensus Criteria (CCC). Id. Ms. Mikovits

states that the CCC does not provide for a diagnosis of ME/CFS if the patient has

received any other diagnosis for the symptoms. Id. In other words, it was strictly a

diagnosis of exclusion. Therefore, because Ms. McCabe had been diagnosed with

another disorder that could account for her symptoms (e.g., depression, insomnia),

she was precluded from a ME/CFS diagnosis at that time. Id. Ms. Mikovits

concluded that “under today’s definition, [Ms. McCabe] would have received a

diagnosis of ME/CFS.” Id. at 2. It is notable, given Ms. Mikovits’ proclamations

to the contrary, that no treating physician has ever diagnosed Ms. McCabe with

CFS. Ms. Mikovits again appears to be playing (medical) doctor.

Ms. Mikovits states that Ms. McCabe had numerous disorders “strongly

associated with dysregulation of inflammatory cytokines and chemokines central to

the development of ME/CFS.” Id. at 3. She cites exhibit 83 (Vincent C. Lombardi

et al., Xenotropic Murine Leukemia Virus-related Virus-associated Chronic

Fatigue Syndrome Reveals a Distinct Inflammatory Signature, 25 In Vivo 307

(2011)) as evidence of the inflammatory signature of severely ill CFS patients

whose CFS was triggered by an unknown viral illness. Exhibit 81 at 3.

Ms. Mikovits also cites exhibit 84 (Jose G. Montoya et al., Cytokine

Signature Associated with Disease Severity in Chronic Fatigue Syndrome Patients,

114 Proc. National Academy of Sciences E7150 (2017)) as further evidence of a

“cytokine signature” in CFS patients. Exhibit 81 at 3.

51

In summary, she says, “whether or not the prior influenza vaccines did or did

not contribute to Ms. McCabe’s medical status at the time she received the

September 11, 2010 vaccination, there is no question that she had been previously

sensitized to the components of the influenza vaccines and that the timing of her

reaction to the September 11 vaccination was completely appropriate.” Id. at 4.

The bases for many of Ms. Mikovits’ declaratory statements remain unclear.

14. Dr. Levine’s Final Report (Exhibit 90)

In her final report, Dr. Levine again reviews parts of Ms. McCabe’s medical

records, observing that she experienced insomnia three months after her October 2,

2006 flu vaccination. Exhibit 90 at 1. Again, Dr. Levine overlooks Ms. McCabe’s

treatment for insomnia for some time prior. Dr. Levine also notes Ms. McCabe’s

diagnosis with gastritis two months after her October 2008 flu vaccination. Id.

She concludes “[c]learly, she was sensitized to influenza vaccines and the reaction

to that final vaccination was an appropriate temporal relationship.” Id. Dr. Levine

provides no persuasive reason why this is so.

Dr. Levine, again, states that heightened levels of IL-6 are associated with

ME/CFS and other inflammatory diseases. Id. Without citing any literature, Dr.

Levine asserts that “[t]he elevated Interleukin-6 levels that I mention in my

original report are found by researchers studying ME/CFS patients and account for

the abnormal blood brain barrier and thus the cognitive symptoms found in patients

with this disease.” She also, again, notes that since IL-6 is not used in a clinical

setting, it is not surprising that Ms. McCabe never had her IL-6 levels measured.

Id.

Dr. Levine’s final report presents an “alternative theory” that she believes is

“plausible.” Id. at 2. She puts forth the possibility that Ms. McCabe had CFS prior

to her September 11, 2010 vaccination. Id. In fact, Dr. Levine says it is “likely”

that Ms. McCabe had CFS all along. Id. Dr. Levine then asserts that the

September 11, 2010 flu vaccine “worsened” her CFS, causing her to be unable to

function. Id.

Dr. Levine concludes by saying that “[t]he symptoms Ms. McCabe

experienced within six hours and in the subsequent days following the September

10, 2010 Flu Vaccination, completely support the appropriate temporal sequence

of ME/CFS significant aggravation”. Id. Again, no support is given for this

statement beyond her ipse dixit about it being an “appropriate temporal sequence.”

52

15. Concerns Raised on September 6, 2017

Ms. McCabe submitted her pre-trial brief on September 5, 2017. Her

witness list did not include Dr. Axelrod.

In an order dated the next day, the undersigned identified numerous issues

with the brief and directed Ms. McCabe to file a revised version of the document.

Order, issued Sep. 6, 2017, at 1. Chief among the undersigned’s concerns were: 1)

It was not clear if Ms. McCabe believes she had CFS before the vaccination; 2)

Insufficient factual development of Ms. McCabe’s current condition; 3) A lack of

evidence about how one would expect CFS to develop in the absence of the

vaccination; 4) An insufficiently developed medical theory linking the vaccine to

CFS; and 5) The lack of evidence pertaining to the appropriate timing between the

vaccine and the onset, or worsening of, her CFS. Id. at 2-3. The undersigned also

stated a concern that the lack of testimony from Dr. Axelrod would undermine the

weight of Ms. Mikovits’ and Dr. Levine’s testimony because they both adopted his

opinions in their reports. Id. at 3.

Ms. McCabe filed a revised pre-hearing brief on September 11, 2017. The

Secretary filed his brief on September 29, 2017. At the same time, the Secretary

filed the final reports from Dr. Whitton and Dr. Matloubian. Exhibit K; exhibit L.

16. Dr. Whitton’s Final Report (Exhibit K)

Dr. Whitton began his report by questioning Ms. Mikovits’ previous

statement that she had “submitted voluminous literature including a 2014 book

chapter . . . that included 153 references to the potential role of inflammatory

cytokines generated by vaccines in acting as a necessary trigger for the initiation

and progression of disease.” Exhibit K at 1 (citing exhibit 81 at 1). Dr. Whitton

states that he has reviewed the material and “neither that chapter, nor any of the

153 references therein, provides any reliable scientific data regarding the cytokine

responses of humans in response to influenza vaccination.” Exhibit K at 1. Dr.

Whitton specifically points out that the chapter contains only two references to

vaccinations at all and that neither reference to vaccination is supported by a

reference. Id.

Dr. Whitton comments favorably on petitioner’s exhibit 84 (Montoya) and

states that the paper does “extend several published studies suggesting that CFS

may be accompanied by low-level inflammatory responses.” Exhibit K at 1.

However, he notes that this paper has nothing to do with vaccines and

reemphasizes his previous point that the article, like Ms. Mikovits’ previous

53

reports, fails to “provide any reliable data whatsoever regarding the cytokine

responses that occur following flu vaccination.” Id. at 1-2.

Dr. Whitton then comments on Dr. Levine’s final report. His comment is

succinct enough to cite almost in whole:

Dr. Levine claims that flu vaccine triggered cytokine production that

caused disease, but – despite this being her fourth opportunity to do so

– she fails to provide any data to support her assertion. The Court will

recall that, in previous reports, she based her assertion on the

petitioner’s report from Dr. Axelrod – a report that I debunked in Exh.

C. Moreover, Dr. Levine failed to address a paper that I had cited in

Exh. G (my response to her first three reports), in which the authors

had explicitly stated that CFS was NOT associated with adjuvanted

flu vaccination.

Exhibit K at 2.

17. Dr. Matloubian’s Final Report (Exhibit L)

Dr. Matloubian’s final report comments on Dr. Levine’s previous report

(exhibit 90). He stated: “Dr. Levine has not provided any additional information or

literature in support of the diagnosis of ME/CFS in the petitioner” and has “failed

again to provide a medical theory that is supported by evidence in the literature to

link an inactivated non-adjuvanted influenza vaccine to development or

exacerbation of ME/CFS.” Exhibit L at 1.

Dr. Matloubian again rebuts Dr. Levine’s point that Ms. McCabe’s

“gastritis” is evidence of her ME/CFS. Id. Dr. Matloubian points out that Ms.

McCabe was diagnosed with gastropathy, not gastritis. Id. Citing exhibit L2 (M.

Feldman & P. Jensen, Classification and Diagnosis of Gastritis and Gastropathy,

UpToDate (Dec. 17, 2015), www.uptodate.com)), Dr. Matloubian distinguishes

gastritis from gastropathy: “gastritis is predominantly an inflammatory process,

while the term gastropathy denotes a gastric mucosal disorder with minimal to no

inflammation.” Id. Dr. Matloubian adds that gastropathy is associated with the

chronic congestion, which Ms. McCabe experienced. Exhibit L at 2.

Dr. Matloubian disagrees with Dr. Levine’s statement that Ms. McCabe’s

insomnia three months following her September 11, 2010 vaccination could be

associated with the vaccine. Id. He states that she does not provide any

mechanism for elevated cytokine levels being present three months following the

vaccination and provides no explanation for how Ms. McCabe’s vaccine reaction

54

could be three months afterwards for the 2006 vaccination and 6 hours afterwards

for the 2010 vaccination . Id. This criticism dovetails with a later point Dr.

Matloubian raises: “in the absence of even a basic understanding of the cause or

consequence of [ME/CFS], it is virtually impossible to attribute causation or

exacerbation to a specific event, such as vaccination with any degree of medical

certainty.” Id. at 3. Similarly, he states, “it is impossible to define the appropriate

medical time-frame that an event such as vaccination could allegedly lead to

development or aggravation of [CFS].” He concludes: “This likely explains why,

despite multiple opportunities to do so, Dr. Levine has been unwilling, or unable,

to state what the accepted general timeframe is for vaccine-induced ME/CFS.” Id.

18. Concerns Raised on October 4, 2017

A pre-hearing status conference was held on October 4, 2017. The

undersigned again raised the concern that, based on the submitted record, a

reasonable basis for proceeding to the hearing did not exist. Order, issued Oct. 10,

2017, at 3. The undersigned stated that this concern involved both the question of

Ms. McCabe’s diagnosis and the issue of causation. Id.

Ms. McCabe requested a ruling, prior to the hearing, on whether reasonable

basis existed. Without such a ruling, Ms. McCabe stated a concern that proceeding

to the hearing would present a risk of undue hardship. Pet’r’s Mot., filed Oct. 6,

2017. As an alternative, Ms. McCabe requested that the hearing, or at least the

portion concerning causation, be postponed. Id.

Ms. McCabe’s motion was denied. Order, issued Oct. 11, 2017. The

undersigned did advise that Ms. McCabe could always voluntarily conclude her

case prior to the hearing or move for a decision on the record. Id. Ms. McCabe

was ordered to file a status report on her decision regarding how to proceed in this

matter. Id. at 3.

On October 13, 2017, Ms. McCabe stated that she intended to proceed with

the hearing. A three-day hearing was held on October 18-20, 2017. The period for

submitting evidence was closed on October 25, 2017, leaving the matter ripe for

adjudication.

III. Standards for Adjudication

Compensation under the Vaccine Act is available in two major forms. Table

injuries, which presume causation, can be established if a prescribed injury occurs

during a set period of time following a specific vaccination. 42 U.S.C. § 300aa-

11(c)(1)(C)(i). Alternatively, petitioners can receive compensation for injuries not

55

provided for in the Vaccine Injury Table by bringing a successful petition for

compensation under 42 U.S.C. § 300aa-11(c)(1)(C)(ii) of the Vaccine Act.

Here, Ms. McCabe does not claim that CFS constitutes a Table injury under

the Vaccine Act. As an “off-Table Injury,” Ms. McCabe must demonstrate that the

vaccine caused her injury.

Petitioner’s burden of proof as an off-Table injury is explicitly defined by

Congress. The Act provides that a petitioner must show, by a preponderance of the

evidence, that the vaccine sustained or significantly aggravated her illness or

injury. See 42 U.S.C. § 300aa–13(a)(1) and 42 U.S.C. § 300aa-11(c). See also

Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)

(noting that petitioners must prove causation by the traditional tort standard of

preponderance). As for what is specifically required to meet this burden, the

statute requires that the conclusion of the court or special master may not be

“based on the claims of a petitioner alone, unsubstantiated by medical records or

by medical opinion.” 42 U.S.C. § 300aa-13. The statute does not speak to the

strength or reputability of the medical opinion, just that a medical opinion or

medical records are necessary for a claim to be meritorious. Id.

In drawing conclusions on causation, the Federal Circuit has noted that

special masters must be careful not to raise petitioners’ burden by establishing tests

that create requirements not in the statute itself. Capizzano v. Sec'y of Health &

Human Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006) (rejecting a test that required

“epidemiologic studies, rechallenge, the presence of pathological markers or

genetic disposition, or general acceptance in the scientific or medical

communities”); Althen, 418 F.3d at 1279 (rejecting a test requiring “confirmation

of medical plausibility from the medical community and literature” in order to

prove causation-in-fact); Knudsen v. Sec'y of Health & Human Servs., 35 F.3d

543, 549 (Fed. Cir. 1994) (“to require identification and proof of specific

biological mechanisms would be inconsistent with the purpose and nature of the

vaccine compensation program”).

Instead, special masters must consider all the evidence and decide whether

the causal link between the vaccine and the injury was logical and legally probable.

See Knudsen, 35 F.3d at 549 (“The sole issues for the special master are, based on

the record evidence as a whole and the totality of the case, whether it has been

shown by a preponderance of the evidence that a vaccine caused the [] injury.”);

Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)

(“Causation in fact requires proof of a logical sequence of cause and effect

showing that the vaccination was the reason for the injury.”); Hines v. Sec'y of

56

Health & Human Servs., 940 F.2d 1518, 1525 (Fed. Cir. 1991) (“causation in fact

requires proof of a logical sequence of cause and effect showing that the

vaccination was the reason for the injury.”).

IV. Analysis

Three major findings, independently, preclude compensation for Ms.

McCabe. First, the evidence submitted does not provide preponderant proof that

Ms. McCabe suffers from her claimed injury, CFS. Second, the evidence

submitted does not present preponderant proof that her overall condition changed

following the September 11, 2010 flu shot. This finding also means that Ms.

McCabe cannot prevail on a cause of action that the flu vaccine significantly

aggravated her CFS. Third, the evidence submitted does not present preponderant

proof that the flu vaccine caused Ms. McCabe’s injury.

A. Petitioner’s Claimed Injury—CFS

Though not explicitly incorporated into the Althen analysis, the Federal

Circuit has recognized that implicit in the causation-in-fact analysis is the

identification of petitioner’s injury. As the Federal Circuit notes, “a careful

reading of Althen, shows that each prong of the Althen test is decided relative to

the injury.” Broekelschen, 618 F.3d at 1346. The Federal Circuit concludes from

this that “identifying the injury is a prerequisite to the analysis.” Id. This logic

was extended in Lombardi to hold that “the statute places the burden on the

petitioner to make a showing of at least one defined and recognized injury.”

Lombardi v. Sec'y of Health & Human Servs., 656 F.3d 1343, 1353 (Fed. Cir.

2011). Any question about the reach of the preliminary analysis envisioned by the

panels in Broekelschen and Lombardi was, at least partially, quelled in Hibbard,

when the Federal Circuit noted “[i]f a special master can determine that a petitioner

did not suffer the injury that she claims was caused by the vaccine, there is no

reason why the special master should be required to undertake and answer the

separate (and frequently more difficult) question whether there is a medical theory,

supported by ‘reputable medical or scientific explanation,’ by which a vaccine can

cause the kind of injury that the petitioner claims to have suffered.” Hibbard v.

Sec'y of Health and Human Servs., 698 F.3d 1355, 1365 (Fed. Cir. 2012).

Ms. McCabe has not demonstrated that she suffers from her claimed

injury—CFS. Given that Ms. McCabe’s case hinges on her assertion that she

suffers from CFS, her lawyer and her experts should have spent more effort to

establish this central fact. This lack of development occurred despite the

57

undersigned’s reminders that Ms. McCabe had not sufficiently established the facts

necessary to prove that she suffers from CFS.

Granted, demonstrating that a person has CFS is, in one respect, a difficult

task. The underlying pathology of CFS is not known. See generally exhibit M1

(IOM). As a result, there is no “gold standard” test for what is and is not CFS.

This has led to the development of multiple criteria, with the IOM noting that no

fewer than 20 different ways of diagnosing someone with CFS exist. Id. at 38.

This multiplicity could create a challenge if Ms. McCabe were to argue that she

met one criteria, while the Secretary were to argue that she failed under another.

The task here does not present that challenge since Ms. McCabe—despite there

being 20 different criteria to choose from—has not presented a single criteria that

indicates that she suffers from CFS.

In another respect, however, establishing CFS is straightforward. Ms.

McCabe merely could have presented any recognized set of diagnostic criteria and

then attempted to establish facts that show that she meets the criteria. In an order

issued on April 10, 2017, Ms. McCabe was directed to have her expert do just that.

In response, Ms. McCabe submitted a report from Dr. Levine that said, in relevant

part:

Reference 1 describes:

Page 5 (exclusion of other causes of fatigue, including 'cardiac and

pulmonary dysfunction') as was done by normal [chest x-ray] and

troponin level (to exclude myocardial infarction)

Page 6 (under last paragraph Canadian ME/CF Case definition); 'short

term memory' and 'lightheadedness')

Reference 2 describes:

Under 'B Neurological Impairments' page 329

Short term memory loss'

'Pain': significant pain'

Sleep disturbances: 'disturbed sleep patterns'

58

Under 'C Immune, Gastrointestinal and genitourinary impairments'

'Nausea' page 330

Thus, 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 2.

It would appear, based on Dr. Levine’s analysis, that she diagnosed Ms.

McCabe simply by cherry-picking certain parts of the diagnostic criteria (e.g.,

‘short term memory loss’) and matching those terms with some of Ms. McCabe’s

complaints. This approach to her diagnosis fails for two reasons. First, she failed

to present the entire criteria for any definition that she used and, as such, failed to

address all of the required elements of the proposed diagnostic criteria. Second, in

attempting to satisfy specific elements of the diagnostic criteria, Dr. Levine

sometimes failed to address findings from Ms. McCabe’s own treating physicians

demonstrating that she did not have the impairments that Dr. Levine assumed she

did. These points are addressed below.

1. Diagnostic Criteria for CFS

Dr. Levine cites different criteria, never landing on a preferred set. In her

report, as quoted above, Dr. Levine refers to two different criteria: “Reference 1”

and “Reference 2”. Exhibit 72 at 6. “Reference 1” is an article that, briefly,

covers the Canadian Consensus Criteria (CCC). “Reference 2” is the International

Consensus Criteria (ICC). Although Dr. Levine referenced the International

Consensus Criteria, her hearing testimony indicates that she based her conclusion

that Ms. McCabe suffered from CFS on the Canadian Consensus Criteria. See Tr.

443-44 (Dr. Levine testifying that this was because she views the CCC as being

“more tested in time”). Then, in her testimony, Dr. Levine added a third set — the

criteria from the IOM.17 Because it is not clear which criteria the petitioner

17

Dr. Levine’s delayed discussion of the IOM report was surprising. The IOM issued its

report in 2015, making it much more current than either the CCC from 2003 or the ICC from

2011. The IOM is also recognized for the credentials of its members and the quality of its

reports. Therefore, it would seem that the 2015 IOM report would be the first stop, not the third.

Moreover, because Dr. Levine’s practice is devoted to treating patients with CFS, it

would be easy to infer that, as an expert in the field, Dr. Levine would know about the 2015 IOM

59

embraced, all three criteria are evaluated below. All three diagnostic criteria are

divided into inclusionary criteria and exclusionary criteria. The analysis for the

exclusionary criteria are relatively homogenous and thus are described together

after reviewing the inclusionary criteria for all three first.

Canadian Consensus Criteria

The CCC was published in 2003 to provide a working case definition to

those making diagnoses of CFS. Exhibit M1 (IOM) at 48. Even though Dr.

Levine concluded that Ms. McCabe satisfies the CCC, she never actually presented

the criteria. However, the CCC is summarized in the IOM report:

Required Symptoms:

 Fatigue

 Post-exertional malaise (PEM) and/or fatigue

 Sleep dysfunction

 Pain

 Two or more neurological/cognitive manifestations

 At least one symptom from two of the following categories:

 Autonomic

 Neuroendocrine

 immune

 Illness lasting ≥ 6 months

Exhibit M1 (IOM) at 42 (Table 3-1).

report. However, even this slight inference is not necessary because Dr. Levine was a reviewer

of the 2015 IOM report. Exhibit M1 (IOM) at 9.

60

Several of these criteria are problematic given the facts. It is not clear that

Ms. McCabe can satisfy the requirements of fatigue,18 PEM, and pain.19 It is also

unclear whether Ms. McCabe has one symptom from two of either autonomic,

neuroendocrine, or immune dysfunction.

Resolving whether Ms. McCabe has established, on a preponderance of the

evidence basis, these criteria is not necessary however, because she almost

certainly does not fulfill another criteria: “Two or more neurological/cognitive

manifestations.” Two neurologists examined her and found her normal. Exhibit 6

at 4 (Dr. Herbstein); exhibit 8 at 5 (Dr. Forster). In addition, a neuropsychologist

also found her normal. Exhibit 8 at 19 (Ms. Borod, Ph.D.). The evaluations from

these professionals weigh more heavily than Ms. McCabe’s testimony that she

suffers from short term memory loss and other cognitive symptoms. See

Capizzano, 440 F.3d at 1326 (noting the importance of contemporaneously created

medical records). As a result, Ms. McCabe cannot satisfy the CCC on this basis

alone.

International Consensus Criteria

Dr. Levine also references the International Consensus Criteria (ICC). See

exhibit 62 (Carruthers). The ICC was published in 2011 and was developed using

the CCC as a foundation, but made “significant changes.” Id. at 328. While the

ICC now calls the condition Myalgic Encephalitis (ME) as opposed to CFS, it

appears that 1) this decision was not without criticism, and 2) that it is ultimately a

18

While it is undisputed that Ms. McCabe had long-standing fatigue, different CFS

criteria require different levels of fatigue. For example, the revised CCC requires a “substantial

reduction in functioning.” Exhibit M1 (IOM) at 72. Dr. Levine said that in evaluating her

patients to see if the level of fatigue reaches the level necessary for a diagnosis of CFS, she has

them complete a questionnaire, filed as exhibit 91. Exhibit 90 at 2.

As explained in more detail below, see Section IV.B, Ms. McCabe did not present

persuasive evidence that her functioning was substantially reduced. For instance, Ms. McCabe

never completed Dr. Levine’s questionnaire. The same general critique is true for whether Ms.

McCabe experiences PEM.

19

Ms. McCabe periodically reported pain. But, as respondent points out, Ms. McCabe’s

pain has been associated with degeneration in her back. Exhibit H at 2 (“The petitioner had other

explanations for her musculoskeletal complaints, such as back pain, which could be related to the

documented degenerative joint disease affecting her spine.”). See also exhibit A at 9 (“Ms.

McCabe has known multilevel degenerative disk disease in cervical, thoracic, and lumbar spine

and osteoporosis which were known to be present before September 11, 2010 and which are

expected to cause intermittent or more enduring symptoms.”). As noted in Section IV.A.1.d, a

known etiology for certain symptoms can preclude their use as being indicia of CFS.

61

matter of semantics. For ease of consistency, this decision will continue to refer to

the condition as CFS.

The ICC, as an initial matter, requires that a patient have symptoms that

result in a substantial reduction in activity compared to premorbid activity levels.

A 50 percent reduction is only considered “mild.” Id. at 329. Based on the record,

it is not clear if Ms. McCabe experienced such a decrease in her activity levels.

See footnote 18, above. Beyond this, the ICC also requires:

 Post-exertional neuroimmune exhaustion (PENE)

 At least one symptom from three of the following four neurological

impairment categories:

o neurocognitive impairments

o pain

o sleep disturbance

o neurosensory, perceptual, and motor disturbances

 Immune, gastrointestinal, and genitourinary impairments. At least one

symptom from three of the following five categories:

o flu-like symptoms

o susceptibility to viral infections with prolonged recovery periods

o gastrointestinal tract

o genitourinary

o sensitivities to food, medications, odors, or chemicals

 At least one symptom from energy production/transportation impairments:

o cardiovascular

o respiratory

o loss of thermostatic stability

o intolerance of extremes of temperature

Id. at 329-31.

Dr. Levine asserted that Ms. McCabe met this definition because Ms.

McCabe had short term memory loss, pain, sleep disturbances, and nausea.

Exhibit 72 at 2. Dr. Levine does not explicitly explain how these four items fulfill

the criteria. Even without this explanation, it seems readily apparent that Ms.

McCabe does not fulfill all the criteria. For example, the neurologists’ and

neuropsychologist’s records indicate that Ms. McCabe does not have a

neurocognitive impairment. Dr. Levine also did not cite any medical record

indicating that Ms. McCabe suffered from “neurosensory, perceptual, and motor

62

disturbances.” Therefore, it appears that Ms. McCabe did not fulfill the second

criteria of the ICC.

Institute of Medicine Criteria

The third criteria Dr. Levine referenced is the IOM criteria for CFS. Dr.

Levine actually served as a reviewer for the IOM report, which she testifies,

constitutes “the latest case definition of this illness.” Tr. 276.

The IOM criteria benefits from a certain simple elegance compared to the

other criteria. A diagnosis of CFS is satisfied when a patient demonstrates (i) a

substantial decrease in function, (ii) that decrease persists for greater than 6

months, (iii) is characterized by post-exertional malaise and unrefreshing sleep,

and (iv) the patient has either 1) a cognitive impairment, or 2) orthostatic

intolerance. Exhibit M1 (IOM) at 210.

As stated above, the records do not demonstrate that Ms. McCabe has a

cognitive impairment. Every neurological exam in the record returns a normal

result. Thus, for Ms. McCabe to fulfill the IOM criteria, she must establish

“orthostatic intolerance.”20, 21

Ms. McCabe did not persuasively establish that she has “orthostatic

intolerance.” Preliminarily, Ms. McCabe did not identify any reports from treating

doctors diagnosing her with orthostatic intolerance. As a result, she had Dr.

Levine interpret the notes in the record and, based on those notes, provide an

opinion that Ms. McCabe had orthostatic intolerance. See Pet’r’s Revised Br. at 22

(“Ms. McCabe [was diagnosed with] Sinus Tachycardia which is Postural

Orthostatic Tachycardia (POTS)”). Dr. Levine expanded on this conclusion in her

testimony. When asked if Ms. McCabe “probably has POTS,” she responded:

A. Yes, POTS, right, is an -- and let me just explain that briefly.

POTS has to do with reduced cardiac output, and so what happens is

20

This assumes that Ms. McCabe demonstrated the other criteria, including “a substantial

decrease in functioning” and “post-exertional malaise.”

21

Orthostatic intolerance is a general term that can refer to a wide range

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