D.G. v. Secretary of Heath and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 11-577V

Filed: May 24, 2019

To be Published

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D.G., *

*

Petitioner, *

*

v. * Influenza (“flu”) vaccine; seizures;

* autoimmune autonomic neuropathy;

SECRETARY OF HEALTH * gastroparesis; POTS; myasthenia

AND HUMAN SERVICES, * gravis; conversion disorder

*

Respondent. *

*

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Lisa A. Roquemore, Rancho Santa Maria, CA, for petitioner.

Justine E. Walters, Washington, DC, for respondent.

MILLMAN, Special Master

DISMISSAL DECISION1

On September 9, 2011, petitioner filed a petition under the National Childhood Vaccine

Injury Act, 42 U.S.C. § 300aa-10-34 (2012), alleging that influenza (“flu”) vaccine administered

on August 23, 2009 caused her muscle weakness, fatigue, dizziness, excessive sweating

especially after meals, whose onset was 10 days post-vaccination. On September 12, 2009, she

alleged she had seizure and fainting after breakfast. On September 17, 2009, she alleged

1

Vaccine Rule 18(b) states that all decisions of the special masters will be made available to the public unless they

contain trade secrets or commercial or financial information that is privileged and confidential, or medical or similar

information whose disclosure would constitute a clearly unwarranted invasion of privacy. This means the decision

will be available to anyone with access to the Internet. When such a decision is filed, petitioner has 14 days to

identify and move to redact such information prior to the document’s disclosure. If the special master, upon review,

agrees that the identified material fits within the banned categories listed above, the special master shall redact such

material from public access. On August 16, 2017, petitioner filed a status report in which she informally moved to

change the caption to reflect just her initials “for privacy reasons.” S.R., at 2. On the same date, the undersigned

granted petitioner’s informal motion to redact her name to her initials and ordered the Clerk of Court to change the

case caption, which the Clerk of Court did. This case is already redacted.

vasovagal syncope,2 benign systolic murmur, positive ANA,3 multiple somatic complaints,

anxiety, dystonia, neurocardiogenic syncope,4 and postural orthostatic tachycardia syndrome

(“POTS”).5 Pet. at ¶¶ 9, 12, 13, 15, 15, 19, 20, 23, 25, 28. 31, 34, 38, 41. Petitioner’s affidavit,

dated September 7, 2011, was attached without an exhibit number.

PROCEDURAL HISTORY

On September 9, 2011, this case was assigned to former Special Master Daria J. Zane.

On February 21, 2012, petitioner filed a status report regarding record collection in which

petitioner’s original counsel Robert J. Krakow stated that he was having difficulty obtaining

treatment records from Dr. Rashid A. Buttar because of an unpaid bill reflected in Exhibit 56.

S.R., at 5. Mr. Krakow states that Generation Rescue offered to pay for all medical treatment

and expenses for petitioner’s medical treatment by Dr. Buttar, an osteopath. Id. at 6. The

condition for Generation Rescue’s payment of petitioner’s medical treatment and expenses was

petitioner’s agreement to being on video during Dr. Buttar’s treatment of her. Id. Mr. Krakow

states that for reasons Generation Rescue did not explain to petitioner, Generation Rescue

discontinued its involvement with Dr. Buttar’s treatment of petitioner and refused to pay her

medical bills for that treatment. Id.

On May 9, 2012, petitioner filed as Exhibit 58 an external terabyte hard drive with the

name “DG Copy” consisting of files of videos. Each video is marked by the name of the digital

file or folder as the files appear on the hard drive.

On July 16, 2012, petitioner’s counsel filed a motion to withdraw. Mot. Petitioner wrote

her counsel on May 30, 2012, stating that “she wished to ‘take over representation of my case’

and instructed counsel to discontinue representation of her before the Court for all purposes.”

Mot., at 1.

On October 2, 2012, petitioner filed a consented Motion to Substitute Attorney, which

former Special Master Zane granted on October 22, 2012.

2

Vasovagal syncope is “a transient vascular and neurogenic reaction marked by pallor, nausea, sweating,

bradycardia, and rapid fall in arterial blood pressure which, when below a critical level, results in loss of

consciousness and characteristic electroencephalographic changes. It is most often evoked by emotional stress

associated with fear or pain.” Dorland’s Illustrated Medical Dictionary 1818 (32nd ed. 2012) [hereinafter,

“Dorland’s”].

3

ANA or antinuclear antibodies are “antibodies directed against nuclear antigens; ones against a variety of different

antigens are almost invariably found in systemic lupus erythematosus and are frequently found in rheumatoid

arthritis, scleroderma (systemic sclerosis), Sjögren syndrome, and mixed connective tissue disease. Antinuclear

antibodies may be detected by immunofluorescent staining. Serologic tests are also used to determine antibody

titers against specific antigens.” Dorland’s at 101.

4

Neurocardiogenic syncope is “a serious type of vasovagal syncope precipitated by a stimulus that causes either

bradycardia, a decrease in vascular tone, or both at once.” Dorland’s at 1818.

5

Postural orthostatic tachycardia syndrome (POTS) is “a group of symptoms (not including hypotension) that

sometimes occur when a person assumes an upright position, including tachycardia, tremulousness, lightheadedness,

sweating, and hyperventilation; this is seen more often in women than in men, and the etiology is uncertain.”

Dorland’s at 1844.

2

On December 6, 2012, petitioner filed a Statement of Completion.

On March 19, 2013, respondent filed his Rule 4(c) Report, recommending against

compensation.

On June 11, 2013, petitioner filed a status report regarding her review of video footage

and attached a list of those videos which she contended were relevant and irrelevant. Videos

included interviews on the television shows “20/20,” “Inside Edition,” “60 Minutes,” “NBC

Washington,” “Fox D.C. News,” and “NBC Charlotte News,” videos of petitioner incapable of

walking forward and then running races, and multiple videos during the week she spent at Dr.

Buttar’s treatment center in North Carolina.

On July 7, 2013, former Special Master Zane issued a decision awarding interim

attorneys’ fees and costs to petitioner’s former attorney, stating that the special master concluded

a reasonable basis existed only up to the point of petitioner’s former counsel’s withdrawal.

“Whether a reasonable basis existed beyond this point and continues to exist to date cannot be

decided based on the record at present, and this decision should not be construed as making any

such decision.” Int. Fees Dec. at 5 n.7. Former Special Master Zane awarded petitioner’s former

counsel $44,961.65 in fees and costs. Id. at 8. Judgment entered on August 2, 2013.

On September 4, 2013, this case was reassigned to former Special Master Lisa Hamilton-

Fieldman.

On October 22, 2013, petitioner filed the expert report of Dr. Lawrence Steinman, a

neurologist. Ex. 65. This was over two years after she filed her petition.

On April 25, 2014, respondent filed the expert report of Dr. Peter D. Donofrio. Ex. B.

On May 30, 2014, former Special Master Hamilton-Fieldman issued a decision awarding

petitioner’s interim costs of $2,950.29. Judgment entered on July 1, 2014.

On August 14, 2014, petitioner filed the first supplemental expert report of Dr. Steinman.

Ex. 92.

On August 19, 2014, former Special Master Hamilton-Fieldman issued an Order for

petitioner to file a second supplemental report from Dr. Steinman, explaining how demyelination

led to the variety of petitioner’s symptoms.

On August 28, 2014, petitioner filed Dr. Steinman’s second supplemental report. Ex.

108.

On January 13, 2015, respondent filed the expert report of Dr. Eric Lancaster, a

neurologist. Ex. H.

On January 15, 2015, the case was reassigned to the undersigned.

On February 20, 2015, respondent filed the expert report of Dr. J. Lindsay Whitton. Ex.

Z.

On June 1, 2015, petitioner filed a third supplemental report of Dr. Steinman. Ex. 118.

3

On August 11, 2015, respondent filed a Motion for Issuance of Subpoena to obtain any

and all documentation, video files, audio files, news releases, reporting, or broadcasts, and/or

website postings/updates relating to petitioner posted on Dr. Buttar’s websites. On the same

date, the undersigned granted respondent’s motion.

On September 4, 2015, respondent filed the first supplemental expert reports of Dr.

Lancaster (Ex. RR) and Dr. Whitton (Ex. SS).

On October 13, 2015, petitioner filed a supplemental declaration in support of her

petition (Ex. 139). She explains how she became a media star by saying she alerted her family

and friends about her physical problems. Ex. 139, at 4. One of her former colleagues was

working for the county newspaper and asked if he could do an article in his paper explaining her

condition and its being tied to flu vaccine. Petitioner writes she agreed since he was a friend and

struggling to get started in his new job. Petitioner writes:

After I learned that the flu vaccine was causing my issues, I

thought I was doing a public service by speaking out as perhaps the

batch of vaccine I received was tainted. From there the media

circus began, starting with local stations contacting me to national

syndicates. However, I remember one of my doctors or

psychologists recommending later on that I should avoid the media

as the chaos was probably not helping my symptoms, but likely

contributing to them.

Id.

Petitioner continues in her supplemental declaration by saying that she thought her first

attorney Robert Krakow, whom her then-husband hired per Stan Kurtz’s recommendation, was

involved to help her deal with media relations. Id. She continues:

At this time, I was also contacted by Stan Kurtz from Generation

Rescue, who is an anti-vaccine advocate. He and his organization

quickly commandeered my injury to turn it into a poster story for

their cause against vaccines[.] [I]n exchange they promised to

“cure” me with the help of Dr. Buttar. Upon the advice of Dr.

Buttar, I declined Dr. Cintron’s plasmaparesis [sic]

recommendation and started receiving [Dr. Buttar’s] protocol of

several bags of IV hydration mixed with his own cocktail of

vitamins. This began to relieve quite a bit of the dizziness and

fainting I had when I stood up or ate. Slowly, my speech started to

improve and I could eat, but limited amounts of food. . . .

Id. at 4-5. Petitioner then goes through the videos respondent’s neurologic expert Dr. Lancaster

saw and about which he comments in his first expert report (Ex. H). Petitioner gives her own

interpretation of them. Id. at 8-25. She mentions giving an interview to channel 5 and stating

she could not walk or talk normally and the only thing she could do was run. Id. at 10. She

4

states her voice returned when she was running. She told John Henry of Channel 5 that when

she runs, her heart rate would go down to 60, whereas when she walked, her heart rate was in the

130s. Id. at 10.

She mentions that Dr. Buttar talked about getting thousands of patients after airing on

television petitioner’s treatment with him. Id. at 23. He talked about people paying $500-600

for his drops. Petitioner states she is not sure how the drops work, but they did seem to improve

her muscle weakness, but much faster than her myasthenia drugs do because of the drops’ rapid

absorption through her skin. Id. Petitioner describes getting an EEG with Ms. Preston, whom

she refers to as “Dr.” Preston even though she is a Ph.D., not a medical doctor. Id. at 24.

Petitioner says Dr. Preston determined petitioner was having seizure. Id.

On January 13, 2016, petitioner filed a fourth supplemental report of Dr. Steinman. Ex.

141.

On April 26, 2016, respondent filed a CD with Exhibits AAA-JJJ, consisting of the

following: Ex. AAA, “20/20” broadcast, approximately July 25, 2010; Ex. BBB, “Inside Edition

Update,” February 4, 2010; Ex. CCC, “20/20” broadcast followed by Robert Scott Bell show;

Ex. DDD, [D.G.] update, October 29, 2009; Ex. EEE, “NBC Washington,” October 15, 2009;

Ex. FFF, “Fox 5 DC News,” October 15, 2009; Ex. GGG, “Inside Edition,” October 16, 2009;

“Ex. HHH, “Fox 5 DC News,” October 19, 2009; Ex. III, “NBC Charlotte,” November 5, 2009;

and Ex. JJJ, “Fox 5 DC News,” November 19, 2009. 6

From June 14-17, 2016, the undersigned held a four-day hearing. On the second day of

the hearing, petitioner sank from her chair to the floor in the hearing room, making growling

noises. The undersigned asked petitioner’s expert Dr. Steinman to attend to her while the

undersigned’s law clerk called 911. Petitioner was transported by ambulance to MedStar

Georgetown University Hospital, which necessitated the obtaining of those hospital records and

the subsequent opinions of the experts interpreting those records after the hearing.

On July 14, 2016, respondent filed the second supplemental expert report of Dr. Whitton.

Ex. YYY.

Also, on July 14, 2016, petitioner filed the fifth supplemental expert report of Dr.

Steinman. Ex. 181.

On September 7, 2016, petitioner filed her second supplemental declaration (Ex. 190).

Attached to her declaration is a copy of e-mail she sent to her treater Dr. Joey R. Gee consisting

of her question and his response (Attachment 2): [D.G.] “Given the positive GAD7 antibody

6

Respondent also relied on the videos respondent identified as Respondent’s Trial Exhibit 58-1 to Respondent’s

Trial Exhibit 58-66, which were specific videos derived from petitioner’s Exhibit 58 (the external terabyte hard

drive). Doc 143. Respondent relied on additional videos identified by dates from October 17, 2009 to October 22,

2009 including nine undated videos. Multiple videos come from Dr. Buttar’s treatment center. Respondent’s expert

Dr. Lancaster identifies the videos upon which he relies as support for his opinion in his first expert report (Ex. H).

Respondent added Respondent’s Trial Exhibit 58-66 to the prior list of Respondent’s Trial Exhibit 58-1 to

Respondent’s Trial Exhibit 58-65 at the hearing, noted in a filing dated June 21, 2016. Doc 147.

7

GAD or glutamate decarboxylase or glutamic acid decarboxylase is “an enzyme of the lyase class that catalyzes

5

result, do you think this explains some of the spasms and tremors you saw in the videos online

when you first took me on as a patient.” Petitioner then says that when she tried to go off

gabapentin8 a year previously, a lot of her symptoms returned, necessitating her going back on

gabapentin, and she wondered if the drug were masking her symptoms. Dr. Gee responded, “It

just might…I did think about that. The spasms can be quite extreme. I am dealing with this

same issue now with a new patient and her GAD have been fluctuating between 10 to over 100[;]

she is on IVIG now.”

On October 14, 2016, petitioner filed the sixth supplemental expert report of Dr.

Steinman. Ex. 191.

On December 16, 2016, respondent filed the third supplemental expert report of Dr.

Whitton (Ex. ZZZ) and the second supplemental expert report of Dr. Lancaster (Ex. FFFF).

On May 16, 2017, petitioner filed the seventh supplemental expert report of Dr.

Steinman. Ex. 198.

On May 17, 2017, petitioner filed her third supplemental declaration (Ex. 205), arguing

that respondent’s neurologic expert Dr. Lancaster was wrong for assuming Dr. Gee told the

treating doctors at MedStar Georgetown University Hospital that petitioner had a “non-organic

(psychogenic)9 gait disorder.” Ex. 205, at 3. She asserts that in the five years she has been

seeing Dr. Gee, he never “even insinuated” that she had an underlying psychogenic illness. Id.

Also, on May 17, 2017, the undersigned issued an Order to petitioner that she file by June

19, 2017 a statement from Dr. Gee indicating whether he believed petitioner had a high GAD

antibody in 2009 and, if she did, whether the high GAD antibody could have caused some of

petitioner’s spasms and tremors that she manifested in 2009 in her videos. Moreover, the

undersigned asked Dr. Gee to opine whether he thought petitioner had myasthenia gravis in 2009

and, if he did not think she did, then how would a purportedly high GAD antibody be connected

to her spasms and tremors in 2009. Dr. Gee never provided petitioner with answers to the

undersigned’s questions. Therefore, the undersigned never learned if petitioner’s assertions in

her third supplemental declaration (Ex. 205) as to what Dr. Gee told her were accurate.

On June 19, 2017, petitioner filed the eighth supplemental expert report of Dr. Steinman,

answering the questions the undersigned asked Dr. Gee to answer in her Order of May 17, 2017,

even though the undersigned addressed those questions to Dr. Gee and not to Dr. Steinman. Ex.

206.

On September 15, 2017, petitioner filed an amended petition, which repeats in detail her

prior allegations. She states flu vaccine caused her the following conditions: (1) autoimmune

the decarboxylation of glutamate to form ƴ-aminobutyrate (GABA). The enzyme is a pyridoxal phosphate protein,

and the reaction occurs within the mitochondria in kidney, and outside the mitochondria in brain. Deficiency of the

brain enzyme may be the cause of convulsions that begin in infancy and are responsive to pyridoxine therapy.”

Dorland’s at 790.

8

Gabapentin is “an anticonvulsant that is a structural analogue of ƴ-aminobutyric acid (GABA), used as adjunctive

therapy in the treatment of partial seizures; administered orally.” Dorland’s at 753.

9

Psychogenic means “produced or caused by psychological factors. See also psychosomatic.” Dorland’s at 1549.

6

autonomic neuropathy/dysautonomia;10 (2) myasthenia gravis11 and in parenthesis states the

following: petitioner admits myasthenia gravis is not her expert Dr. Steinman’s “favorite”

diagnosis; instead it is Dr. Geoffrey L. Sheean’s diagnosis and Dr. Steinman puts a high value on

Dr. Sheean’s opinion; and (3) autoimmunity to GAD. Am. Pet. at ¶ 60.

On October 30, 2017, petitioner filed the ninth supplemental expert report of Dr.

Steinman. Ex. 208. On the same date, respondent filed the fourth supplemental expert report of

Dr. Whitton (Ex. MMMM) and the third supplemental expert report of Dr. Lancaster (Ex.

QQQQ).

On February 7, 2018, petitioner filed her post-hearing brief.

On May 31, 2018, respondent filed his responsive post-hearing brief.

On July 2, 2018, petitioner filed her reply post-hearing brief.

Petitioner filed 209 exhibits and respondent filed 80 exhibits, for a total of 289. The

undersigned has read all of them and the entire 1,110-page transcript. The undersigned has

weighed the conflicting opinions of the experts and observed their demeanor at trial. The

undersigned has seriously considered the opinions of the 58 treating/diagnosing doctors and two

psychologists.

Because the evidence in this case as well as the more persuasive opinions of respondent’s

experts and supporting medical literature show that petitioner did not have an adverse reaction to

flu vaccine, the undersigned DISMISSES this case.

FACTS

Prevaccination Records

Petitioner was born on December 23, 1983. She is 35 years old.

Prior to vaccination, petitioner was generally healthy without significant medical

problems. She had a medical history of bronchitis, nose surgery, bulimia,12 and breast

augmentation surgery. Med. recs. Ex. 2, at 11-12; Ex. 9, at 2-3; Ex. 21, at 1-2; Ex. 22, at 24-26.

On November 29, 2004, petitioner saw Dr. Michael Rodriguez of Broadlands Family

Practice, complaining of a fungus for the past week or two. Med. recs. Ex. 11, at 33. Petitioner

10

Dysautonomia is “malfunction of the autonomic nervous system.” Dorland’s at 575.

11

Myasthenia gravis is “an autoimmune disease of neuromuscular function due to the presence of antibodies to

acetylcholine receptors at the neuromuscular junction; characteristics include muscle fatigue and exhaustion that

fluctuates in severity, without sensory disturbance or atrophy. It may be restricted to one muscle group or become

generalized with severe weakness and sometimes respiratory insufficiency. It may affect any muscle of the body,

but especially those of the eyes, face, lips, tongue, throat, and neck.” Dorland’s at 1214.

12

Bulimia is “episodic binge eating usually followed by behavior designed to negate the excessive caloric intake,

most commonly purging behaviors such as self-induced vomiting or laxative abuse but sometimes other methods

such as excessive exercise or fasting.” Dorland’s at 259.

7

weighed 137 pounds. She had a temperature of 100 degrees. Her blood pressure was 130/60.

Id. Dr. Rodriguez diagnosed petitioner with tinea nigra13 (ringworm). Id. at 34.

On November 16, 2006, petitioner saw Dr. Rodriguez of Broadlands Family Practice, for

tinea nigra. Id. at 32.

On July 2, 2008, petitioner saw PA-C Deirdre Ellis at Broadlands Family Practice,

needing a health screening for work. Med. recs. Ex. 22, at 29. Her history included rare to

occasional EtOH (ethanol). Id.

On December 16, 2008, petitioner saw Dr. Huong Thai-Kemprowski, an allergist and

immunologist, for an evaluation of environmental allergies. Id. at 82. Petitioner stated she had

rhinorrhea, nasal congestion, and constant sniffing. She said she had had constant nasal

congestion for the prior 10 years. She has sneezing and itchy eyes in the spring. Her father had

allergic rhinitis. She has post-nasal drip. Id. Physical examination of petitioner’s nose showed

enlarged turbinate with nasal obstruction left greater than right. Id. at 83. Test results showed no

sensitivity to tree pollens, grass pollens, weed pollens, dust mites, cockroach, cat, dog, horse, and

mold spores. Dr. Thai-Kemprowski’s impression was there was no evidence of allergic rhinitis.

Id.

In March 2009, petitioner became a Washington Redskins Cheerleader Ambassador14 as

a public relations representative for the Washington Redskins. Med. recs. Ex. 31, at 2.

On April 10, 2009, petitioner and her then-husband saw psychologist Christine M.

Cosgrave for petitioner’s then-husband’s psychotherapy. Med. recs. Ex. 187, at 1, 3.

On May 14, 2009, petitioner saw Dr. Elizabeth Mann at Broadlands Family Practice,

complaining of headache, sore throat, and chills. Med. recs. Ex. 31, at 27. Dr. Mann diagnosed

petitioner with allergic rhinitis. Id. at 28.

On May 18, 2009, petitioner saw Dr. Rodriguez at Broadlands Family Practice,

complaining of moderate to severe cough for several days. Id. at 25. She felt tired, achy, and

had trouble sleeping. Id. Dr. Rodriguez diagnosed her with acute bronchitis. Id. at 26.

On June 22, 2009, petitioner went to Dr. Rodriguez, complaining of moderate to severe

cough for several days. Id. at 23. She felt tired, achy and had trouble sleeping. Id. Dr.

Rodriguez diagnosed petitioner with acute bronchitis. Id. at 24.

Postvaccination Records

13

Tinea nigra is “a minor fungal infection, caused by Hortaea werneckii, having dark lesions that look like spattered

silver nitrate on the skin of the hands or occasionally other areas.” Dorland’s at 1930.

14

“Selected during the Redskins Cheerleaders auditions process every April, the Ambassadors’ main focus is

interacting with fans during all Redskins home games at FedExField. While the Redskins Cheerleaders captivate the

90,000+ fans with energetic dance routines, the Ambassadors are in the AAA Ultimate Fan Zone, Touchdown Club

and Suites—and even in the stands—bringing a personal, up-close interaction with fans.” Washington Redskins

Cheerleader Ambassadors, ULTIMATE CHEERLEADERS, https://ultimatecheerleaders.com/tag/ambassadors/ (last

visited Mar. 18, 2019).

8

On August 23, 2009, petitioner received flu vaccine at a Safeway Pharmacy in Reston,

Virginia. Med. recs. Ex. 4, at 3.

On September 12, 2009, petitioner was transported via emergency medical services

(“EMS”) to the emergency department (“ED”) at Inova Loudoun Hospital, complaining of

weakness, overall not feeling well for the last nine days, subjective fevers, body aches,

weakness, and dizziness although she worked full time and ran every day to train for a 5K race.

Med. recs. Ex. 5, at 6, and Ex. 51, at 112. Petitioner reported having bronchitis four to five times

since February 2009 treated with antibiotics, although she still had a productive cough and

fatigue. Id. The assessment was rhabdomyolysis,15 near syncope, recurrent respiratory issues,

elevated liver function test. Med. recs. Ex. 51, at 113. Petitioner had no problem getting out of

bed to a chair and her speech and thoughts were clear. Id. The nursing assessment noted

petitioner was hyperventilating, complaining of fever, syncope, dizziness, nausea, non-

productive cough, pain in her left upper quadrant, shivering, and feeling cold. Her speech was

clear and understandable. Her temperature was normal. Med. recs. Ex. 5, at 15. The onset of

symptoms was sudden. She did not have any associated shortness of breath. She reported that

she “was watching TV and almost passed out and began to shake.” Id. at 9. She reported a

history of lightheadedness, dizziness, weakness, subjective fevers, and body aches over the

previous nine days. Id. at 6, 9. Petitioner said she had a sore throat for several days the prior

week. Id. at 10.

On physical examination, Dr. Zachary Malachias noted petitioner was well-appearing,

alert and oriented, appeared comfortable, and had a normal pulse and blood pressure, but an

increased respiratory rate. Id. Neurologically, she did not have focal motor deficits, focal

sensory deficits, or nystagmus.16 She had intact cranial nerves and normal speech. She was

oriented, and had normal affect, insight, and concentration. Id. Her EKG was normal. Id. Her

oxygen saturation was normal. Id. at 11. Petitioner was admitted to the hospital. Id. On blood

testing in the ED, petitioner’s mono percentage was high at 10.9. Id. at 12. She tested negative

for both influenza A antigen and influenza B antigen, indicating she did not have the flu. She

tested negative for mono. Id. Her creatine kinase (“CK”)17 tested high at 12,018 U/L when the

normal range is between 19-204. Id. at 13. Her myoglobin18 tested high at 675 ng/mL when the

15

Rhabdomyolysis is “disintegration or dissolution of muscle, associated with excretion of myoglobin in the urine.”

Dorland’s at 1637. Myoglobin is “the oxygen-transporting pigment of muscle [which] combines with oxygen

released by erythrocytes, stores it, and transports it to the mitochondria of muscle cells, where it generates energy by

combustion of glucose to carbon dioxide and water.” Id. at 1223.

16

Nystagmus is “an involuntary, rapid, rhythmic movement of the eyeball, which may be horizontal, vertical,

rotatory, or mixed.” Dorland’s at 1307.

17

Creatine kinase (CK) is “an Mg2+-activated enzyme of the transferase class that catalyzes the phosphorylation of

creatine by ATP to form phosphocreatine. The reaction effectively stores the energy of ATP as phosphocreatine in

muscle and brain tissue and holds the muscle concentration of ATP nearly constant during the initiation of exercise.”

Dorland’s at 429. ATP is adenosine triphosphate. Id. at 173. Adenosine triphosphate is “a nucleotide, the 5’-

triphosphate of adenosine, involved in energy metabolism and required for RNA synthesis; it occurs in all cells and

is used to store energy in the form of high-energy phosphate bonds. The free energy derived from hydrolysis of

ATP is used to drive metabolic reactions including the synthesis of nucleic acids and proteins, to move molecules

against concentration gradients (active transport), and to produce mechanical motion (contraction of microfibrils and

microtubules).” Id. at 30.

18

Myoglobin (Mb) is “the oxygen-transporting pigment of muscle, a type of hemoprotein resembling a single

9

normal range is 0-62. Id. at 14. Her CKMB19 mass tested high at 7.49 ng/mL when the normal

range is 0.00-3.38. Id.

As an inpatient, petitioner reported during a History and Physical that she had bronchitis

four to five times since February 2009 and was treated with antibiotics, although she still had a

productive cough and fatigue. Id. at 6. Despite her symptoms, petitioner was working full-time

and running every morning to train for a 5K race. Id. Petitioner had a history of eating disorder

years ago. Id. Her history also includes turbinate20 reduction, rhinoplasty,21 and breast

augmentation. She reported a questionable blood transfusion during her breast augmentation

surgery. Id. Her white count was 10.9. Id. She had no acute findings on chest x-ray. Id. She

was negative for flu. Id. at 7.

On physical examination, petitioner was alert and oriented. Id. She was not in acute

distress. The diagnosis was rhabdomyolysis, leukocytosis,22 and near syncope. Petitioner did

not have any gross neurologic deficits. She was out of bed to a chair without difficulty. Her

speech and thoughts were clear. Petitioner had recurrent respiratory issues of an ongoing cough

and fatigue. Id. She had an increased respiratory rate, but she was otherwise afebrile with no

abnormalities. Id. at 10. Petitioner was diagnosed with rhabdomyolysis, leukocytosis, near

syncope, recurrent respiratory issues, elevated liver function tests, and a heart murmur. Id. at 7.

She was admitted to the hospital for hydration with IV fluids. Id. at 7. The results of her chest

x-ray on September 12, 2009 and brain CT scan were normal. Id. at 25, 26. Her chest x-ray on

September 13, 2009 showed small non-specific hypodensities in her thyroid. Id. at 28. Her EKG

on September 12, 2009 was normal. Id. at 31.

Petitioner was discharged on September 14, 2009. Med. recs. Ex. 5, at 2. Dr. Brian A.

Hazen wrote the discharge summary stating serial laboratory tests included a CPK which was

12,018 on September 12, 2009, but 6,546 on September 13, 2009; an AST23 which was 366 on

September 12th, but 167 on September 14th; and an ALT24 which was 102 on September 12th, but

80 on September 14th. Id. Dr. Hazen stated these test results were probably reflective of muscle

damage and not a hepatic process. Petitioner’s long-term goal was long-distance running. Dr.

Hazen told her to get one more test of her CPK and liver function before ensuring she had

completely resolved from the muscle damage of rhabdomyolysis. In the meantime, he said it

subunit of hemoglobin, composed of one globin polypeptide chain and one heme group (containing one iron atom);

it combines with oxygen released by erythrocytes, stores it, and transports it to the mitochondria of muscle cells,

where it generates energy by combustion of glucose to carbon dioxide and water.” Dorland’s at 1223.

19

CKMB is “CK2 (MB) … primarily in cardiac muscle.” Dorland’s at 429.

20

Turbinate is “any of the nasal conchae.” Dorland’s at 1991.

21

Rhinoplasty is “a plastic surgical operation on the nose, either reconstructive, restorative, or cosmetic.” Dorland’s

at 1640.

22

Leukocytosis is “a transient increase in the number of leukocytes in the blood; seen normally with strenuous

exercise and pathologically accompanying hemorrhage, fever, infection, or inflammation.” Dorland’s at 1028.

23

AST is aspartate transaminase. Dorland’s at 167. “The serum level of aspartate transaminase (SGOT) and that of

other transaminases are frequently elevated in a variety of disorders causing tissue damage.”

24

ALT is alanine transaminase. Dorland’s at 54. Alanine transaminase is “an enzyme found in serum and body

tissues, especially in the liver. Serum enzyme activity (SGPT) is greatly increased in liver disease and also elevated

in infectious mononucleosis.” Id. at 43.

10

was all right for her to do very light, brief aerobic exercise, to stay hydrated, not to do anaerobic

exercise, and to avoid excessive heat. Id. Petitioner’s diagnosis was mild rhabdomyolysis. Id.

On September 17, 2009, petitioner returned to the ED at Inova Loudoun Hospital,

complaining of sudden lightheadedness, blackout, and shortness of breath, noting immediate

restoration of normal mental status. Med. recs. Ex. 51, at 13. Dr. Pranav Vermani did a physical

examination, noting weakness bilaterally in the upper extremities and profound weakness

bilaterally in the lower extremities. Id. at 14. On the same day, during a consultation with Dr.

Sarbjot S. Dulai, a neurologist, petitioner reported that she had subjective fevers, chills, body

aches, generalized fatigue, weakness, and intermittent lightheadedness. Id. at 21. She had

shortness of breath and tingling in her feet and hands when she was hyperventilating. Id.

Petitioner continued to train for a 5K race. Although she was admitted to Inova Loudoun

Hospital on September 12, 2009 and discharged on September 14, 2009, she continued to have

subjective chills and fevers, generalized body aches, and intermittent lightheadedness. She

claimed multiple brief episodes of passing out which occurred only when she was sitting or

standing. She thought her shortness of breath was related to hyperventilation, when she would

get some tingling in her feet and hands. Petitioner received intravenous hydration in the

emergency room. She reported some headaches without visual changes or problems with

speech, swallowing, or balance. Id. Dr. Dulai noted petitioner had very minimal weakness

proximally in the lower extremities. Id. at 4, 23. Petitioner’s neurologic examination was

otherwise unremarkable. Id. at 23. Dr. Dulai’s impression was that petitioner’s symptoms were

due to a continuation of her viral syndrome and possibly a component of dehydration. Id.

On September 17, 2009, petitioner’s AST was high at 60 U/L when the normal range is

5-40. Med. recs. Ex. 6, at 6. Her ALT was also high on September 17, 2009 at 61 U/L when the

normal range is 7-56. Id. On September 17, 2009, petitioner’s ANA was 1:80 when normal is

less than 1:40. Med. recs. Ex. 22, at 76. On September 18, 2009, petitioner’s AST returned to

normal at 38 and her ALT returned to normal at 48. Med. rec. Ex. 6, at 6. On September 17,

2009, petitioner’s CK was elevated at 485 U/L when the normal range is 19-204. Id. at 7. It was

still elevated, but less so, on September 18, 2009 when the CK measured 236 U/L. Id. On

September 17, 2009, petitioner’s C-reactive protein was negative. Id. at 17.

On September 17, 2009, petitioner had a brain MRI with and without contrast. Id. at 37,

and Ex. 51, at 48. Dr. Ho-Song Lee wrote the brain MRI was normal. There was no mass,

hemorrhage, or extra-axial fluid collection. The gray matter, intracranial vessels and

postcontrast exam were normal. Petitioner had mild left maxillary sinus membrane thickening.

Id.

On September 18, 2009, petitioner had a consultation with Dr. Jeffrey S. Luy, a

cardiologist, who observed normal muscle strength and tone on physical exam. She also had

normal and appropriate affect. Med. recs. Ex. 51, at 25; Ex. 6, at 1-4; Ex. 22, at 58-59. Dr.

Luy’s impression was that petitioner’s syncope was “probably vasovagal due to some relative

element of dehydration,” prior rhabdomyolysis which had improved, and benign systolic heart

murmur. Med. recs. Ex. 51, at 25. Dr. Luy recommended discharge with fluid, Tylenol, and

rest. Id. On the same day, petitioner was discharged with a diagnosis of “syncope, likely

11

vasovagal, history of recent rhabdomyolysis, underlying etiology not clear, possible viral illness

with complaint of still being tired and fatigued” and instructions to follow up with her primary

care physician (“PCP”). Id. at 4-5 and med. recs. Ex. 22, at 48.

On September 21, 2009, petitioner visited her primary care physician (“PCP”) Dr.

Michael Rodriguez at Broadlands Family Practice with concerns of multiple episodes of near

syncope over the past couple of weeks. Med. recs. Ex. 22, at 19. She said that she would feel

dizzy, nauseated, and as if she were going to pass out. Id. She asked Dr. Rodriguez to review

her ED records and tests because she was convinced that her symptoms were due to Lyme

disease even though a Lyme test was negative. Id. On physical examination, Dr. Rodriguez

observed normal joints and muscles. Id. at 20. Dr. Rodriguez referred petitioner to an infectious

diseases specialist, Dr. Sarfraz A. Choudhary, and a rheumatologist, Dr. Alexia Gospodinoff. Id.

On September 22, 2009, petitioner visited Dr. Choudhary with complaints of headache,

neck pain, multiple joint pains, and pseudoseizures. Id. at 56. On physical examination, Dr.

Choudhary found nothing remarkable. Id. Dr. Choudhary stated the possibilities included

“psychological as [petitioner] had a history of bulimia, tick borne illness like Lyme disease, and

viral illnesses like West Nile.” Id. at 57. He ordered a spinal tap with Inova Loudoun Hospital

to rule out any neurological etiology. Id. Dr. Choudhary also recommended counseling and

reassurance, discussed different infection control precautions, and had petitioner follow up with

her neurologist and cardiologist. Id. A lumbar puncture was performed on September 24, 2009

and the evaluation of lupus was negative. Med. recs. Ex. 7 at 1 and Ex. 44, at 16, 29.

Petitioner’s lumbar puncture showed a normal cerebrospinal fluid (“CSF”) of 24 mg/dL when

the normal range is 15-60. Med. recs. Ex. 7, at 2.

On September 26, 2009, petitioner went to Inova Fairfax Hospital ED, complaining of

three days of unsteady gait, difficulty with speech, syncope when standing up, shakiness,

constant fatigue, an achy neck, headache, and difficulty sleeping. Med. recs. Ex. 44, at 136.

Petitioner told Dr. Scott Weir that she was recently discharged from Loudon Hospital on

September 21, 2009 for the same symptoms and that she received flu vaccine three days before

her symptoms began. Id. Petitioner arrived via stretcher since she was unable to ambulate. Id.

at 137. Petitioner’s speech was clear and understandable. Her bilateral hand grasp was weak

and toes were progressing upward. Petitioner reported “it feels like numb spots in my mind.” Id.

Petitioner’s family reported petitioner seemed confused at times and sometimes could not finish

her sentences. Id. Her C-reactive protein was normal. Id. at 142. Petitioner said the onset of

symptoms was gradual and occurred on September 3, 2009, starting with a fever and headache.

She developed syncopal episodes after meals, difficulty speaking and concentrating, tremors in

her neck, head, and arms, weakness in her legs, and a wide-based and unsteady gait. She said

she received flu vaccine on August 30, 2009 (the wrong date; she received flu vaccine on August

23, 2009). She was admitted to Loudoun Hospital for a cardiac syncopal workup and discharged

on September 21, 2009 with no definitive diagnosis. Petitioner stated she developed intermittent

paresthesia25 in her legs and arms. She developed seizure-like episodes two days previously with

25

Paresthesia is “an abnormal touch sensation, such as burning, prickling, or formication, often in the absence of an

external stimulus.” Dorland’s at 1383.

12

jerking of her arms and legs, but no postictal period or incontinence. Petitioner states she knew

what was happening but could not stop her muscles. She denied slurred speech and stated she

has difficulty concentrating and difficulty getting words out. Id. Petitioner reported chills,

fatigue, weakness, vision changes, seeing visual spots, syncope, nausea, arthralgias, myalgias,

and joint stiffness. Id.

Physical examination showed petitioner was ill-appearing and uncomfortable. Id. at 143.

The range of movement of her neck was within normal but difficult due to tremulous movements

and stiff motions. She had a tremulous head. Her extremities had 4/5 strength. She had

dysmetria26 on cerebellar examination. Petitioner was admitted to the hospital for neurologic

examination. Id.

On admission, petitioner complained of a four-day history of worsening and bilateral

lower and upper extremity weakness, difficulty ambulating, and generalized tremors with

multiple vague somatic complaints. Med. recs. Ex. 9, at 1-2; Ex. 44, at 1 (complaining of

syncope, low blood pressure, with an admitting diagnosis of other malaise and fatigue); Ex. 22,

at 50. She complained of having “sweating” in the central core area and mid-epigastric pain that

stopped beneath the sternum. Med. recs. Ex. 44, at 55. She was discharged on September 29,

2009 with a principal diagnosis of abnormal involuntary movement not elsewhere classified

(“NEC”), and secondary diagnoses of lack of coordination, other malaise and fatigue, conversion

disorder,27 obstructive sleep apnea, and stuttering. Med. recs. Ex. 44, at 8.

Dr. Mohammed A. Mannan was petitioner’s attending physician. Med. recs. Ex. 9, at 1.

Petitioner told Dr. Mannan that she had been in excellent health until around August 30, 2009

(which would be one week after she received flu vaccine). Id. She said within a few days after

getting a flu vaccination, she had a flu-like illness with upper respiratory symptoms,

bronchorrhea,28 sore throat, mild nonproductive cough, fevers, chills, and diffuse myalgias. She

had some lightheadedness, dizziness, and syncopal episodes and presented to Inova Loudon

Hospital. (She went to Inova Loudon Hospital on September 12, 2009.) Id. Dr. Mannan notes

in petitioner’s records that petitioner had a positive ANA “which was only 1:80.” Id.

26

Dysmetria is “a condition in which there is improper estimation of distance in muscular acts, with disturbance of

the power to control the range of muscular movement, often resulting in overreaching.” Dorland’s at 578.

27

Conversion disorder is “a mental disorder characterized by conversion symptoms (loss or alteration of voluntary

motor or sensory functioning suggesting physical illness, such as seizures, paralysis, dyskinesia, anesthesia,

blindness, or aphonia) having no demonstrable physiological basis and whose psychological basis is suggested by

(1) exacerbation of symptoms at times of psychological stress, (2) relief from tension or inner conflicts (primary

gains) provided by the symptoms, or (3) secondary gains (support, attention, avoidance of unpleasant

responsibilities) provided by the symptoms. Many patients exhibit “la belle indifference,” a lack of concern about

the impairment caused by the symptoms; histrionic personality traits are also common. Symptoms are neither

intentionally produced nor feigned, and are not limited to pain or sexual dysfunction.” Dorland’s at 549.

Dyskinesia is “distortion or impairment of voluntary movement, as in tic, spasm, or myoclonus.” Id. at 578.

Myoclonus is “shocklike contractions of a portion of a muscle, an entire muscle, or a group of muscles, restricted to

one area of the body or appearing synchronously or asynchronously in several areas.” Id. at 1222. Aphonia is loss

of voice, mutism. Id. at 115.

28

Bronchorrhea is “excessive discharge of mucus from the bronchi.” Dorland’s at 253.

13

Petitioner complained that she had progressive deterioration in the prior four days and

some new symptoms, including symmetric lower greater than upper extremity weakness and

difficulty ambulating, as if her legs were going to buckle due to weakness. She was much more

fatigued and very easily winded with minimal exertion. However, she denied any shortness of

breath at rest, but stated she got very exhausted and short of breath with any minimal exertion.

She reported difficulty sleeping. She stated she had onset of worsening uncontrollable tremors at

times that became worse with effort or exertion. She had intermittent headaches, but no vision

changes. She stated that, at times, she had trouble concentrating and had stuttering speech, but

not specific slurring. She denied the following: difficulty swallowing, chest pain, recent cough,

palpitations, nausea, vomiting, abdominal pain, diarrhea, constipation, urinary changes, calf pain,

swelling, orthopnea, or PND (paroxysmal nocturnal dyspnea29). She described occasional

shooting tingling pains in her lower extremities more than in her upper extremities which was

symmetric. She stated her sensation was intact. She reported intermittent, mainly frontal but

occasionally diffuse, headaches, giving a vague description of occasionally feeling cold spots in

the back of her head. She reported some fainting episodes and occasional lightheadedness which

was somewhat worse when she was upright. She described recent fevers as occasional hot

flashes but did not measure them. She said she received a flu vaccine two to three years ago

without problems. Id. at 2. Her past medical history included chronic bronchitis, bulimia,

obstructive sleep apnea with turbinate reduction around 2008, rhinoplasty, breast augmentation,

intestinal surgery in early childhood, and oral and genital herpes. Id. at 2-3. A chest x-ray done

on September 26, 2009 because petitioner complained of shortness of breath was stable. Dr.

Elise Berman noted petitioner had degenerative change to her right AC (acromioclavicular) joint.

Id. at 7.

On physical examination, petitioner’s blood pressure was 110/60 and her pulse 70. Id. at

3. She was alert and oriented, well-nourished, somewhat anxious, and generally fatigued, but

generally comfortable. She was very easily fatigued with minimal activity. Id. She did not have

a heart murmur. Id. at 4. Her C3 and C4 complement levels were normal at 85 and 15

respectively.

Dr. Mannan’s impression was multiple somatic complaints following flu vaccination

initially with flu-like illness with myalgia, rhabdomyolysis, and mild transaminitis (high level of

enzymes), all of which resolved. She had recurrent near syncope and syncope. Id. Petitioner

did not lose her distal deep tendon reflexes. Conversely, she complained of generalized tremors

and possible hyperreflexia, more so in the upper extremities and worse with effort. Dr. Mannan

wrote that “Etiology regarding above constellation of symptoms is not entirely clear at present.”

Id.

On September 27, 2009, Dr. Jonathan Bresner, a neurologist, saw petitioner because of

abnormal movements. Med. recs. Ex. 44, at 29. Petitioner said that on September 23, 2009, she

had shooting pains in various parts of her body and sensory changes in her head. She felt as

though her whole body was hot although her hands and feet were cold. She described seeing

white spots in her vision and had intermittent headaches. She had lab work done and the only

29

Dyspnea is “breathlessness or shortness of breath; difficult or labored respiration.” Dorland’s at 582.

14

abnormality was an ANA of 1:80. Petitioner’s lumbar puncture was normal. Id. A family friend

who is a physician was concerned petitioner had GBS because of her difficulty breathing, which

is why she returned to the ED. Id. at 29-30. She had a history of bronchitis five times in the last

year and going to the ED for severe abdominal pain. Id. at 30. On physical examination,

petitioner had fluent speech, but also stuttering and halting speech. She was alert, oriented, and

anxious. Her strength was 5/5 throughout. Her tone was alternating and uncoordinated with

tremors, contractions, dystonic30 posturing, and myoclonic jerks. She had spastic jerking

movements of the limbs and at times dystonic posturing as well. Her reflexes were 1 to 2+. She

was able to walk unassisted, but had jerking movements of her entire body while she was

walking. Id.

Petitioner’s lab results were normal for CK, C-reactive protein, and erythrocyte

sedimentation rate. Id. at 31. The protein in her CSF was 24. Dr. Bresner’s impression was

multiple complaints progressing over the last month as well as progressive tremulousness and

abnormal body movements for the prior several days. Dr. Bresner states:

The observed movements are extremely peculiar and not easily

described from a neurological standpoint. It is also odd that the

patient’s symptoms resolved for a long enough period each

morning for her to apply makeup but then return so forcefully that

she is unable to speak or move her limbs in any sort of coordinated

motion. The patient is able to walk despite her inability to control

her limbs . . . . I am reassured that her neurological exam is

otherwise normal and had an extensive workup including

laboratory CSF and reportedly a brain MRI are also unremarkable,

excluding a borderline elevated ANA. … I was originally asked to

assess the patient for Guillain-Barre syndrome. There is [sic]

currently no signs or symptoms on her exam to suggest this

diagnosis. A psychogenic etiology to the patient’s symptoms

remains a consideration. The patient might benefit from

psychological counseling or psychiatric evaluation. . . .

Id. at 31-32.

On September 28, 2009, petitioner had a psychiatric consultation on a question of

conversion disorder with Dr. Paul M. Dellemonache. Med. recs. Ex. 21, at 1-6, and Ex. 44, at

33-38. Petitioner reported that she had a history of bulimic and self-induced vomiting behavior

during her teens “to control something since my father controlled me.” Med. recs. Ex. 21, at 2.

Neurology had seen petitioner and did not feel her signs and symptoms were consistent with a

clear neurologic etiology and questioned a psychogenic element. Id. at 1. The only stressor

petitioner could mention within the past year was her younger sister’s suicide attempt. Id.

Petitioner felt her sister did that to get attention as she had apparently done before. Petitioner

stopped speaking with her sister who had since moved out of petitioner’s house and back in with

30

Dystonia is “dyskinetic movements due to disordered tonicity of muscle.” Dorland’s at 582.

15

petitioner’s father. Petitioner reported her other siblings agree with her regarding her sister, but

denied that this caused any difficult family strife. Petitioner did not speak to her mother after her

parents’ separation when she was 18 years old. Id. Petitioner thought her mother was jealous of

petitioner’s relationship with her father. Id. at 3. She was not distressed when her parents

separated because she felt her father could do better. Petitioner moved out of the house when she

was 18 to her own house which she then flipped and moved into a bigger house but lost its equity

when the housing market declined. She went straight to work at AOL after high school. In order

to get onto the Washington Redskins cheerleading team, she had breast augmentation which she

felt was a necessity to get onto the team. She practices once or twice a month and enjoys it. She

also enjoys marathon running. Id. Petitioner noted that her illness had brought her then-husband

and her “even closer together.” Id. at 5.

Petitioner said she had bronchitis several times over the prior year and thought her

symptoms might be due to Lyme disease because she had several coworkers and friends who

themselves or their family members had Lyme disease with similar presentations and she had

many tick bites on her legs in the past from running outside. Id. at 2. She also mentioned that

she had a flu vaccination at the end of August which might or might not be related to her

symptoms. Id. Dr. Dellemonache noted that conversion disorder is a “diagnosis of exclusion,”

which could not be conclusively diagnosed until all other workups were exhaustive and

continued to be negative. Id. A lupus anticoagulant evaluation done on September 28, 2009

resulted in no detection. Med. recs. Ex. 8, at 6, 9. Testing for Epstein-Barr virus antibody and

IgG was positive, but IgM was negative. Id. at 10. Cytomegalovirus was not detected. Id. at 16.

On September 28, 2009, petitioner and her then-husband met with a social worker

Michelle Ougheltree. Med. recs. Ex. 44, at 57. Petitioner still had a significant stutter.

Petitioner was assisted in walking that morning by two persons because her knees buckled and

currently her knees and hips hurt. Petitioner was interested in outpatient therapy. Petitioner’s

then-husband requested SW Ougheltree complete a short-term disability form as petitioner’s sick

leave had run out. The social worker would give the form to petitioner’s PCP. Id.

On September 29, 2009, petitioner was discharged. Dr. Mannan diagnosed her with

“multiple somatic complaints and progressive but fluctuating neurologic deficits (including

abnormal movements/tremors and speech) of unclear etiology, not fitting any particular pattern.

Possible psychogenic etiology. No evidence of GBS.” Id. at 13. He also said that petitioner’s

orthostatic hypotension was likely due to volume depletion and it improved with intravenous

hydration. Dr. Mannan writes that at the time of petitioner’s presentation, she had “very odd

neurological symptoms with difficulty walking and tremors during evaluation of strength.” Id.

However, petitioner’s reflexes were normal, and she did not have any focal findings. Id. Dr.

Bresner in the ED suspected petitioner’s neurological symptoms were not consistent with GBS

and there could be a psychogenic component to her symptoms. Id. at 13-14.

In his discharge summary, Dr. Mannan drew attention to the fact that petitioner “was

unable to hold a cup of water in her hand without spilling; however, she was able to fully put

makeup on in the morning during hospitalization, including eyeliner, without complication until

confronted by the nursing staff, after which she no long could do this task.” Id. at 14. All of

16

petitioner’s lab tests, including Lyme disease, repeat ANA, antiphospholipid antibody panel,

West Nile, and H1 N1, were negative. Id. Dr. Mannan discussed with petitioner’s then-husband

putting petitioner on doxycycline even though multiple tests for Lyme disease were negative.

Her then-husband said petitioner had been very concerned about possible Lyme disease after

researching it on the internet and he felt petitioner would be greatly reassured by empiric

treatment for it. Dr. Mannan gave petitioner a one-week course of doxycycline upon discharge.

In addition, petitioner was treated with IV hydration to help with orthostatic and volume

depletion during this hospitalization. Id. Dr. Mannan spoke with petitioner’s PCP Dr. Rodriguez

who also did not see any clear evidence of obvious organic etiology, and seemed concerned

about a psychogenic etiology, and agreed with a psychiatric evaluation. Id. Petitioner requested

a note for short-term disability but Dr. Mannan suggested she follow up with Dr. Rodriguez

because there was no clear diagnosis. Id. Lab results showed a negative C-reactive protein and a

sedimentation rate of 19. Her cortisol at 10.7 was normal as was her B-12. ANA was detected

with a ratio of 1:80. Lyme antibodies were negative. Med. recs. Ex. 22, at 49.

On October 2, 2009, petitioner saw Dr. Garry Ho at Broadlands Family Practice, for a

consultation and to review her recent medical problems. Med. recs. Ex. 22, at 15-17. She

discussed multiple sclerosis (“MS”) with Dr. Ho. Id. at 15. Petitioner reported that she woke up

on September 24, 2009 with trouble walking “like I had MS.” Id. She also reported that she

developed dysarthria and stuttering when she tried to talk out loud on September 26, 2009. Id.

At that time, petitioner was in the process of setting up an admission to Johns Hopkins Hospital’s

neuromuscular neurology service. Id. On physical examination, Dr. Ho found petitioner had a

broad-based, spastic, stamping and waddling gait, and dysarthric and stuttering speech. Id. at 16-

17.

On October 2, 2009, petitioner went to Johns Hopkins Medicine ED and spoke to Dr.

Julius C. Pham. Med. recs. Ex. 55, at 24. Johns Hopkins was to evaluate whether petitioner had

GBS since she reported lower leg weakness that progressed to her upper legs, increased

difficulty speaking and walking, and shortness of breath. Id. She had uncontrollable bobbing of

her head when speaking or making intentional movements. She also described electric-like

shooting pains starting in her legs and moving around her body. She also had symptoms of

dysphonia that whispering or singing in a high-pitched voice relieved. She had difficulty using

her lower limbs for prolonged periods of time because either they gave out or she had

uncontrollable movements in them. Id. Petitioner complained of a headache at the base of her

neck which was constant and dull. Id. When it went away, she had diffuse, cool spots all around

or she developed a headache behind her right eye and again had cool sensations. Id. at 24-25.

Petitioner said she had episodes of uncontrollable blinking that she was unaware of and

photophobia. Id. at 25. She had mild congestion and intermittent tinnitus in her left ear that

woke her. She had dysgeusia.31 Petitioner had inappropriate episodes of uncontrollable laughter.

She had autonomic dysfunction with hot flushing at the core and cool extremities. She had

syncopal episodes associated with eating, and loss of consciousness without incontinence or

tongue biting after she had bobbing of her head. Her sleep cycle was off. She had increased

31

Dysgeusia is parageusia. Parageusia is “a bad taste in the mouth.” Dorland’s at 577, 1375.

17

appetite and a recent two-pound weight loss. Warm water worsened her symptoms, particularly

at her knees. Petitioner told Dr. Pham she received flu vaccine on August 30, 2009 (not the true

date of August 23, 2009). She was taking doxycycline and prednisone.32 Id.

On physical examination, petitioner did not have nystagmus. Id. Her lower extremities

were cool to the touch. Id. at 26. On motor examination, petitioner had an abnormal, ataxic,

waddling/wide stance. Her strength was 4/5 in the upper and lower extremities. Her right upper

extremities were weaker, but her grip was equal. Petitioner tapped her foot and her head bobbed.

Dr. Pham’s final assessment was that petitioner presented with multiple neurologic findings both

central and peripheral in nature. The final diagnosis was weakness. Dr. Pham wrote petitioner

had a complex problem, which was likely neurological, but for which she had not received a

diagnosis even though several outside medical facilities and neurologists had evaluated her.

About one month ago, she was normal. Since then, she developed lower extremity weakness,

paresthesia, and some dysphonia. The differential diagnosis included GBS, MS, Lyme, and

myasthenia gravis. Id. Petitioner awaited admission to neurology for unexplained ascending

weakness and head bobbing. Id.

A nursing assessment dated October 2, 2009 notes that petitioner was brought to a room

by wheelchair with ED staff. Id. at 27. Petitioner told RN Michelle E. Charron that she had pain

in both ears when she tried to speak. Petitioner said she had difficulty breathing “like I can’t get

enough oxygen.” Id. She said she had nausea after eating and weight loss despite increased food

intake. She had 5/5 muscle strength throughout. She had severely stuttering speech which began

one week previously. She reported progressive weakness in her lower extremities moving up her

legs. Id. RN Pia L. Bolano did a reassessment, during which petitioner denied shortness of

breath, and denied nausea, vomiting, diarrhea or abdominal pain. Id. RN Czereyna C. Pearl

similarly wrote petitioner denied shortness of breath, nausea, vomiting, diarrhea or abdominal

pain. Id. at 28. RN Pearl noted petitioner’s positive stuttering. Id. at 28. A chest x-ray done on

October 2, 2009 was normal. Id. at 33. On October 2, 2009, petitioner had an MRI of her

lumbar spine which did not show abnormal enhancement within the cervical, thoracic, or lumbar

spinal cord or cauda equina. Id. at 18. She had mild degenerative changes including a T7-T8

disc bulge and annular tears in the L4-L5 and L5-S1 discs. Id.

On October 3, 2009, petitioner was admitted to Johns Hopkins Hospital. Med. recs. Ex.

2, at 11. Dr. Anjajl Sharrief took a history that petitioner received flu vaccine on August 30,

2009 (not the true date of August 23, 2009). Three days afterward, she woke with a sore throat

and congestion, progressing to fever and fatigue. She then had severe fatigue and muscle aches

but continued to work. She came to the emergency department on September 12, 2009 with

generalized weakness and lightheadedness. On the day she presented, she reportedly had

generalized convulsions and an episode of syncope. Her CK was 12,000 on presentation with

MB of 7.5. Myoglobin was 75. Troponin was negative. AST and ALT were elevated at 366

and 102 respectively. Her white blood cell count was 10.6 on admission. This was thought to be

secondary to a viral illness. CK and liver function tests came down with IV fluid hydration. She

32

Prednisone is “a synthetic glucocorticoid derived from cortisone, administered orally as an anti-inflammatory and

immunosuppressant in a wide variety of disorders.” Dorland’s at 1509.

18

was admitted from September 12 to 14, 2009 and discharged home. She went back to work on

September 17, 2009 and began feeling weak with nausea and fainting at work. She began

trembling uncontrollably and was readmitted to the hospital. She was discharged the following

day.

Since her lethargy continued, she saw her PCP on September 21, 2009 who said

petitioner’s ANA was positive at 1:80 and that she had systemic lupus erythematosus (“SLE”).33

Petitioner began having reproducible chest pain and was referred to an infectious disease

specialist and a rheumatologist. When she saw the infectious disease specialist on September 22,

2019, she fainted with convulsions. The doctor had a lumbar puncture performed. Petitioner

began having difficulty ambulating with knees buckling and continued nausea, chills, sweats,

and lightheadedness. She described that at this point she began having vivid dreams and

difficulty sleeping. Id. Petitioner also began having headaches which she told Dr. Sharrief felt

like cold spots in the back of her head. She returned to the hospital on September 27, 2009 with

unsteadiness and difficulty speaking. She described it as pain in her face and neck when she

spoke. She sounded as if she were stuttering. She could talk normally if she whispered. She

began to have symptoms in her toes which petitioner described as their moving erratically and

misfiring. Several specialists whom she saw could not determine the etiology of her symptoms.

She began taking doxycycline for possibly Lyme disease. She also started taking

methylprednisolone34 Dosepak for chest pain which her PCP prescribed. Petitioner’s symptoms

persisted and progressed to intermittent uncontrollable blinking, difficulty focusing, pain in her

neck muscles, uncontrollable shaking, cold feelings in her feet, and sharp pain in her legs. She

was referred to Johns Hopkins ED. Id.

Petitioner’s history was rhinoplasty, breast augmentation, and oral and genital herpes. Id.

at 12. She has a half-sister who had an autoimmune disorder at age four. Her cousin has

Grave’s disease and now breast cancer. Her maternal great aunt has multiple sclerosis. Her

mother’s father’s mother had fibromyalgia. Her maternal grandmother had breast cancer. Her

maternal grandfather had lung cancer. Her father has a benign brain tumor. Petitioner said she

has possible tick bites from a 5K run in August 2009. Id.

On physical examination, Dr. Sharrief noted that petitioner was well-appearing, sitting up

in a stretcher in no apparent distress. Her face was “very well made up.” Id. Her heart rate was

77, and blood pressure 111/63. Neurologically, petitioner was spontaneously alert and oriented.

She was able to give a full history which was limited only by her inability to speak properly. She

had good attention and a normal fund of knowledge. She registered 4 out of 4 items and recalled

4 out of 4 after five minutes. Id. Petitioner spoke in a broken voice taking deep gasps of air

between words. Id. at 13. Her speaking appeared labored. She was able to whisper without a

33

Systemic lupus erythematosus is “a chronic, inflammatory, often febrile multisystemic disorder of connective

tissue that proceeds through remissions and relapses; it may be either acute or insidious in onset and is characterized

principally by involvement of the skin …, joints, kidneys, and serosal membranes.” Dorland’s at 1080.

34

Methylprednisolone is “a synthetic glucocorticoid derived from progesterone, used in replacement therapy for

adrenocortical insufficiency and as an anti-inflammatory and immunosuppressant in a wide variety of disorders.”

Dorland’s at 1154.

19

broken voice. Petitioner explained this by saying speaking in a normal voice caused a strain on

her face and neck muscles.

Petitioner’s shoulder shrug was 5 out of 5. She had normal bulk and tone. She had a

jerky vertical tremor of her head which waxed and waned in intensity depending on her level of

exertion. Tremor also affected her arms and legs. Her strength was 5 out of 5 proximally in the

upper extremities including deltoids, biceps, and triceps. Petitioner had mild weakness (4+ out

of 5) in wrist extension, finger extension, and finger flexors on the left hand. She was strong in

these groups on the right. Her lower extremity strength was notable for some component of

giveaway weakness. Id. Her reflexes were 2+/brisk in her bilateral biceps, triceps,

brachioradialis, patellae, and Achilles. She did not have clonus. Her toes were downgoing

bilaterally. She had intact and symmetric sensation to light touch and temperature proximally

and distally. Her vibratory sensation was intact. Her finger-nose-finger coordination was slow

and brought out severe vertical head tremor as did heel-to-shin testing. She was able to stand

without assistance. Her gait was narrow-based. After taking 2-3 steps, she began to have severe

shaking of her head in a vertical motion and then a bouncing motion of her legs as if her knees

were going to give way. She asked to sit down. Id.

Petitioner’s lab studies showed erythrocyte sedimentation rate on September 26, 2009 of

12, negative results for: ANA, anti-double stranded DNA, lupus, Epstein Barr virus (“EBV”)

IgM. Her EBV IgG was greater than 5, and her EBV viral capsule antigen IgG was 3.8 high. On

September 17, 2009, her C-reactive protein was low titer negative, cortisol was 10.7, ANA was

detected at 1:80, and HIV western blot negative. A lumbar puncture on September 24, 2009

showed zero white blood cells, and a protein of 24. Her Lyme antibodies were negative. Id. On

October 4, 2009, petitioner’s erythrocyte sedimentation rate was normal at 6 mm/hr when normal

is 4-25. Med. recs. Ex. 55, at 66. On October 4, 2009, petitioner’s ANA was positive at 1:320.

Her Lyme disease antibody was negative. Id.

Petitioner’s September 17, 2009 brain MRI was normal with no mass hemorrhage or

extra-axial fluid. She had mild left maxillary sinus membrane thickening. A chest CT on

September 13, 2009 showed soft tissue in the anterior mediastinum probably residual findings

without mass effect. A head CT done on September 12, 2009 was normal. Dr. Sharrief

reviewed the September 17, 2009 brain MRI. The T1 and T2 images showed no signal

abnormality. Id. There was no evidence of masses, ischemic stroke, bleeding, or a

demyelinating process. Med. recs. Ex. 2, at 14.

Dr. Sharrief’s assessment was petitioner did not have significant medical problems until

four weeks before she came to Johns Hopkins. Her presentation began with what seemed like a

viral illness. She had constitutional symptoms and upper respiratory symptoms. She was

admitted to another hospital and found to have elevated CK and elevated liver function tests.

These tests eventually normalized. She had progressive symptoms including some

lightheadedness, many episodes of syncope, tremor in her head, pain in her neck and face which

affected her voice, and inability to ambulate because of perceived weakness in her legs. An

extensive workup included brain MRI, lumbar puncture, and multiple laboratory studies, none of

which were revealing. Her ANA was positive with a low titer of 1:80. Lyme studies were

20

negative. Inflammatory markers were not elevated. She began on doxycycline and prednisone,

but there was no evidence to begin these drugs. Petitioner’s neurologic examination had many

components which were not physiologic. Nevertheless, it was possible that her viral syndrome

had persistent effects which debilitated her. She could have had exposure to ticks within weeks

of her initial presentation. Tickborne illness might explain some of her symptoms, but not many

of her neurologic complains. Dr. Sharrief thought there was currently a likely component of

“psychological overlay contributing to her symptoms.” Id.

Dr. Victor C. Urrutia, a neurologist, assessed that petitioner’s symptoms clearly had a

strong psychogenic component but noted that petitioner did have elevated liver enzymes and

CPK, and could have had a mild post-vaccination reaction with neurological symptoms. Id. He

reassured petitioner that she did not have GBS and there was no evidence that she had SLE or

Lyme. He recommended she stop taking doxycycline and prednisone. He thought if the workup

were negative, she might have had a mild reaction and she would get better soon without specific

treatment. Petitioner told him she saw a psychologist that ruled out stress. Petitioner was

admitted because she could not walk. Id. and med. recs. Ex. 55, at 12. A neurology progress

note dated October 3, 2009 states astasia-abasia.35 Med. recs. Ex. 55, at 85.

On October 3, 2009, petitioner had a brain MRI, which did not show an acute process or

abnormal enhancement. Id. at 15.

On October 4, 2009, Dr. Urrutia further evaluated petitioner. Med. recs. Ex. 2, at 10.

Petitioner stated she felt better and was able to walk backwards and sideways but still not

forward. A physical therapist mentioned dystonia to her. After receiving Ativan36 the prior

night, petitioner felt much better. An MRI of her brain was normal. On examination, petitioner

continued to stutter when she spoke but talked normally if she whispered. She did not have any

focal deficits. She was able to get off the bed and walk normally backwards, but when she

walked forward, she buckled and seemed jerky, but did not fall or hit herself. She managed to

turn around and sit on the bed. Dr. Urrutia’s assessment was that petitioner had “symptoms that

do not fit a physiologic paradigm.” Id. Her symptoms might be a reaction due to anxiety. He

suggested petitioner see a therapist. He prescribed clonazepam37 for management of her

symptoms as they were likely related to anxiety and because she felt better after taking Ativan.

His impression was speech dysfunction and gait dysfunction. Id. On the same day, petitioner

was discharged.

On October 4, 2009, Dr. Christopher B. Oakley wrote the discharge summary. Med.

recs. Ex. 55, at 6. Under the impression that petitioner received flu vaccine on August 30, 2009,

35

Astasia-abasia is “motor incoordination with an inability to stand or walk despite normal ability to move the lower

limbs when sitting or lying down, a form of hysterical ataxia.” Dorland’s at 167. Ataxia is “failure of muscular

coordination; irregularity of muscular action.” Id. at 170. Hysterical ataxia is “ataxia that is part of a conversion

disorder.” Id. at 171.

36

Ativan is “trademark for preparations of lorazepam.” Dorland’s at 173. Lorazepam is “a benzodiazepine with

anxiolytic and sedative effects, administered orally in the treatment of anxiety disorders and short-term relief of

anxiety symptoms and as a sedative-hypnotic agent.” Id. at 1074.

37

Clonazepam is “a benzodiazepine used as an anticonvulsant in the treatment of Lennox-Gastaut syndrome and of

atonic and myoclonic seizures and as an antipanic agent in the treatment of panic disorders.” Dorland’s at 373.

21

Dr. Oakley wrote that petitioner developed URI symptoms that progressed to severe fatigue and

muscles aches, but she continued to work. Petitioner told Dr. Oakley that she was told she had

lupus and Lyme disease. MRIs of petitioner’s cervical, thoracic, and lumbar spine were normal

as was a brain MRI. After receiving Valium,38 she improved. With no other intervention, her

symptoms improved and she was discharged on clonazepam. Her symptoms were thought to be

a stress reaction to what happened weeks earlier when her liver enzymes and CPK were elevated.

Her symptoms might be an anxiety reaction, which was explained to her. She was advised to

undergo physical therapy and have psychological support with a therapist or psychiatrist. “She

was also informed that the relationship with the flu vaccine was not clear.” Id. She was

expected to improve on clonazepam, positive encouragement, and time. Id. Petitioner was able

to speak without abnormalities in a soft whisper with some mild stuttering that improved with

encouragement. Id. at 7. Her eyes did not have nystagmus. On motor examination, she had

normal bulk and tone. Her strength was 5 out of 5 in all extremities. Her reflexes were 2+/brisk

with no clonus and downgoing toes. Finger-nose-finger was slow and brought out severe

vertical head tremor as did heel-to-shin-testing. She was able to stand without assistance. Her

gait was narrow-based. After taking two to three steps, she began to have severe shaking of her

head in a vertical motion, then began to have a bouncing motion of her legs as if her knees were

going to give way, but she did not fall. Her gait improved with reassurance and encouragement.

On October 6, 2009, petitioner visited her PCP Dr. Ho. Med. recs. Ex. 22, at 12.

Petitioner reported that when she touched her anterior left thigh or fastened a belt around her left

thigh, she could walk completely normally. Id. When she did not do this, she could only run

forward, but she could walk backward and sideways normally. Id. She also reported that her

difficulty with talking was relieved by placing a hand on her chin. Id. Petitioner also claimed

that when she took her husband’s 5mg Valium tabs, she was “perfectly normal” for about 10

hours. Id. She had plans to see a dystonia specialist at Mayo Clinic in November 2009. Id.

Upon physical examination, Dr. Ho noted that petitioner was well-nourished and well-groomed,

and had normal strength and tone overall with no atrophy, spasticity or tremors while seated. Id.

at 14. Dr. Ho suggested that if further extensive workups were unrevealing, he would strongly

consider a conversion disorder, delusional disorder, or other psychogenic etiology. Id. at 14.

On October 7, 2009, petitioner completed a Vaccine Adverse Event Reporting System

(“VAERS”) form, giving the wrong date of vaccination, August 30, 2009, and stating onset was

on September 3, 2009 at 6:20 a.m. Med. recs. Ex. 3, at 2. She described the adverse event

symptoms as sore throat, nasal congestions, followed by fever, body aches, chills, and headache.

She states she was hospitalized for eight days and her reaction resulted in permanent disability.

She states that three days after her flu vaccination, on September 3, 2009 (which was 10 days

after her flu vaccination on August 23, 2009), she came down with flu-like symptoms. On

September 12, 2009, she began fainting and going into violent convulsions. Two weeks later,

her legs began to fatigue and her neck began to shake periodically. On September 23, 2009, she

lost the ability to walk and walked as if she had MS. She could not walk straight and her entire

38

Valium is “trademark for preparations of diazepam.” Dorland’s at 2020. Diazepam is “a benzodiazepine used as

an anti-anxiety agent in the treatment of anxiety disorders and for short-term relief of anxiety symptoms, … also as a

skeletal muscle relaxant, anticonvulsant, antitremor agent, antipanic agent . . . .” Id. at 512.

22

body shook when she walked. Id. On September 24, 2009, she lost the ability to talk (stuttering)

and had neck pulls and strains when talking. Her symptoms continued and she was diagnosed

with dystonia. Id. at 3.

On October 9, 2009, petitioner saw Dr. Christine M. Cosgrave, a psychologist, for her

cognitive and emotional issues.39 Med. recs. Ex. 45, at 1-3. Petitioner displayed significant

physical and neurological difficulties and Dr. Cosgrave recommended that petitioner seek an

evaluation by a neurologist and neuropsychologist. Id. at 2. Dr. Cosgrave referred petitioner to

Dr. Sidney W. Binks III, a clinical neuropsychologist, for a neuropsychological evaluation. Id.

On October 12, 2009, petitioner saw physical therapist Dallas A. Simons, a visit that Ms.

Simons described in a letter entitled “To Whom It May Concern,” dated May 12, 2010. Med.

recs. Ex. 16, at 1. Petitioner told PT Simons that she had a muscular problem, which she felt was

a complication of flu vaccination. On October 12, 2009, PT Simons evaluated petitioner’s gait

and found petitioner could walk backward fairly normally, but was very ataxic walking forward.

If petitioner held her thigh, she could walk much more normally. Petitioner spoke very softly,

but if she held her chin, her volume and cadence improved. PT Simons felt this was beyond her

competency to evaluate and did not complete a formal evaluation. PT Simons gave petitioner the

name and phone number of a physical therapist more experienced in neurological problems and

dystonia and did not provide petitioner with treatment. Id.

On October 13, 2009, petitioner saw Dr. Ho, requesting a medical letter supporting

extension of her disability benefits. Med. recs. Ex. 22, at 9. She said that when she touched her

anterior left thigh or fastened a belt around her left thigh, she could walk completely normally.

When she did not do this, she could only run forward, not walk, but she could walk backward

and sideways normally. Her difficulty talking was eased by placing a hand on her chin. She was

discharged from Johns Hopkins on Klonopin40 but, after her first dose, she had “convulsions.”

Id. When she took one of her husband’s Valium tablets, she was perfectly normal for about 10

hours. Id. Dr. Ho discussed petitioner’s findings in her rather extensive work up and said if

further extensive workups at academic centers were unrevealing, he “would strongly consider a

conversion d/o [disorder], delusional d/o, or other psychogenic etiology.” Id. at 10 and 11. Dr.

Ho performed a physical examination and found her reflexes normal, but her gait broad-based

“(VERY ERRATIC [Dr. Ho’s emphasis])”, spastic, stamping (sensory ataxia) and waddling. Id.

at 11. Dr. Ho provided a letter to excuse petitioner from work or school due to her “undergoing

work up and treatment for dystonia of uncertain etiology.” Id. at 38.

39

Petitioner first met Dr. Christine M. Cosgrave on April 10, 2009, when she accompanied her then-husband, B.J.,

for an initial psychotherapy intake session for him. Med. recs. Ex 187, at 3. However, by referral from her

physician, petitioner began her own individual psychotherapy with Dr. Cosgrave on October 9, 2009 to obtain

cognitive and emotional help “associated with possible reaction to an influenza vaccine she reportedly received in

September 2009.” Id. Subsequently, petitioner obtained services from Dr. Cosgrave on October 9, 2009, December

7, 2009, February 12, 2010, and March 5, 2010. Id.

40

Klonopin is “trademark for a preparation of clonazepam.” Dorland’s at 989. For the definition of Clonazepam,

see supra, n.33.

23

On October 15, 2009, petitioner and her then-husband saw Dr. Ruben Cintron,41 a

neurologist. Med. recs. Ex. 1, at 10. The history was that within a few weeks of flu vaccination

in August, she developed flu-like and numerous neurological symptoms, including sensory

symptoms. She had a fair amount of difficulty with her motor system, i.e., speech, gait,

movements, tolerance to eating, and syncope, which had been labeled as a dystonic reaction or

disorder related to vaccination. Id. She was initially diagnosed with rhabdomyolysis with a

CPK in the 13,000 range and elevation of her liver enzymes. MRI of the brain, spinal fluid

analysis, and multiple serologies were all unremarkable. She could not walk forward or

sideways,42 only backward. When she walks, she has jerking episodes. Id. During physical

examination, petitioner was alert and oriented. Her speech was interrupted and non-fluid,

although much better when whispering or singing. Id. at 10. She did not have visual

dysmorphism or dystonic features. Id. at 10-11. When she tried to exert power, she had a fair

amount of clinical rhythmic jerking throughout her shoulder girdles. Id. at 11. At least once,

petitioner lost control with an episode of jerking that seemed to take over her ability to function

motorally. During that time, her heart rate did not seem to have changed, she was aware, and she

came back quickly without lying down. When petitioner tried to walk forward, her legs

collapsed. When she walked backward, she did better. Her reflexes were symmetrical with

downgoing toes. She had normal CSF, brain MRI, test results for Lyme disease and other

serologies. Her CPK elevation ranged from 13,000 to 300. Id. Dr. Cintron’s impression was

that petitioner’s history did “suggest vaccination induced motor disorder, with some dystonic and

myoclonic features.” Id. Dr. Citron did not believe that petitioner had a functional disorder

based on her behavior and the consistency of the behavior. Id. Dr. Cintron prescribed

Cogentin43 and gave petitioner and her then-husband information on plasmapheresis44 and

intravenous immunoglobulin (“IVIG”). Id.

From October 19-22, 2009 and October 26-28, 2009, and on November 18, 2009, and

December 1, 2009, petitioner had treatments with Dr. Rashid Buttar, D.O.45 at his Center for

41

Dr. Cintron received his MD at Wake Forest School of Medicine. He did an internship in internal medicine at

Georgetown University Hospital, followed by a residency there in neurology. He did a fellowship in Neuromuscular

Diseases and Electrodiagnostic Medicine at George Washington University Medical Center. In 1995-1996, Dr.

Cintron became board certified in Adult Neurology and Neuromuscular /EMG. He considers himself a general

neurologist with special interest in neuromuscular disorders/EMG, migraines, movement disorders and memory

disorders. Physicians and Practitioners, NEUROSCIENCE CONSULTANTS, PLC, www.nscpic.com/ruben-cintron-m-d/

(last visited Jan. 9, 2019).

42

This is the first medical record to note petitioner could not walk sideways. In previous histories, she said she

could walk sideways and backward.

43

Cogentin is “trademark for preparations of benztropine mesylate.” Dorland’s at 382. Benztropine mesylate is “an

antidyskinetic believed to act by partially blocking central cholinergic receptors, so that cholinergic and

dopaminergic activity in the basal ganglia is more balanced; used in the treatment of parkinsonism . . . .” Id. at 209.

44

Plasmapheresis is “the removal of plasma from withdrawn blood, with retransfusion of the formed elements into

the donor; generally, type-specific fresh frozen plasma or albumin is used to replace the withdrawn plasma.”

Dorland’s at 1456.

45

The North Carolina Board of Medical Examiners issued a reprimand to Dr. Buttar on March 26, 2010 for not

informing his patients about the types of treatment and therapies he was recommending to them. Dr. Buttar

consented to the reprimand. Licensee Information: Rashad Ali Buttar- DO Full and Unrestricted, NORTH CAROLINA

MEDICAL BOARD,

https://wwwapps.ncmedboard.org/Clients/NCBOM/Public/LicenseeInformation/Details.aspx?EntityID=66840&Pub

24

Advanced Medicine & Clinical Research in Huntersville, North Carolina. See med. recs. Ex. 59,

at 59-83. Petitioner arrived at Dr. Buttar’s clinic with her then-husband, brother-in-law, Stan

Kurtz,46 and a camera crew on October 19, 2009. Id. at 80. Petitioner heard about Dr. Buttar47

from Generation Rescue. Id. at 304.

Petitioner gave Dr. Buttar a timeline including her impression she received flu vaccine on

August 30, 2009. Id. at 90. She described waking up on September 3, 2009 with a sore throat

and congestion. That afternoon, she started feeling fatigue and was very hot. She took a

decongestant and two Aleve. After dinner, she started feeling hot and nauseated. She lay on the

couch and had body aches all over, most severely at the hip muscle and biceps where she had

been working out. From September 4-7, 2009, she mostly slept, had no appetite, and was very

lethargic. Her sore throat and congestion continued. Id. From September 8-11, 2009, she went

back to work, but was constantly lethargic and fatigued. She had a mild sore throat in the

morning, continuing congestion, and a green ball of mucus in the morning. In the evening of

September 11th, she drank a glass of wine and two mixed drinks over a four-hour period starting

at 7:00 p.m. At 11:00 p.m., she started vomiting violently and uncontrollably. On September

12th, she woke up very weak, dehydrated, and tired. She drank lots of fluids and ate breakfast.

Around 11:00 a.m., she became very lightheaded and hot, but her hands and feet were cold. Id.

She fainted while sitting on the couch. She lost all muscle control while trying to walk. She

states she began convulsing and hyperventilating in the car. Id. From September 18-20, 2009,

petitioner states she was still lethargic and weak. She “finally figured out I was fainting and

going into convulsions after eating.” Id. Petitioner would eat while lying down to avoid

fainting. She still was congested with greenish yellow mucus each morning. Id. Petitioner

notes that even by September 28, 2009, she still had congestion with yellow and white mucus.

Id. at 95.

Dr. Buttar stated that petitioner presented to his clinic “in emergent state, in severe

distress with labored breathing, experiencing multiple witnessed, back to back seizures or

contractures, extraordinary gross motor deficits, loss of coordination, absence of fine motor

skills, inability to articulate with dysphonia, and unable to ambulate.” Id. at 74. Petitioner

reported that she had done an 8K race two days previously. Id. Petitioner claimed that she was

able to breathe better while running than at rest. Id. Petitioner lost ten pounds over the last five

licFile=1 (last updated Jan. 16, 2019). On February 10, 2011, the Hawaii Medical Board denied Dr. Buttar’s

application for medical licensure due to the NC Board action. Id. Dr. Buttar lists his area of practice as

occupational and environmental medicine. Id. He was licensed in Texas until 1994. Id. Dr. Buttar does not have

any hospital affiliations. Health, U.S. NEWS & WORLD REPORT, https://health.usnews.com/doctors/rashid-buttar-

626895 (last visited Jan. 19, 2019).

46

Mr. Kurtz has invented treatments to cure autism and was awarded top 20 “Hall of Fame” status by Generation

Rescue. www.stankurtz.org/about/affiliations.html (last visited Jan. 10, 2019). Generation Rescue is an

organization promoting treatment for autism. www.generationrescue.org/who-we-are/ (last visited Jan. 10, 2019).

47

Dr. Buttar has a website: https://www.drbuttar.com (last visited Feb. 12, 2019). It states on its home page that

The Center for Advanced Medicine and Clinical Research specializes in addressing the needs of patients suffering

from chronic disease, treatment failures, difficult to diagnose conditions, cancer, autism, cardiovascular disease,

neurodegenerative disease, environmental toxicity, heavy metal toxicity, chemical toxicity, and metabolism

disorders. It also states its treatments are “so effective that even the North Carolina Medical Board is trying to

suppress the truth” and cites to another website: DrButtarTruth.org. Id.

25

to seven days and experienced inability to “keep foods down.” Id. Dr. Buttar noted that

petitioner experienced nausea, vomiting, and dry heaving throughout the day. Id. at 80. Dr.

Buttar diagnosed petitioner with dystonia by history, acute respiratory distress; acute viral, post-

immunization encephalopathy; allergic reaction to medicinal substance; and rule out heavy metal

toxicity. Id. at 75.

During the following days after arriving at Dr. Buttar’s office on October 19, 2009,

petitioner received IV chelation therapy to “have ability to speak and walk.” Id. at 68-80. Dr.

Buttar noted on October 19, 2009 that petitioner tolerated the IV well and it made a “huge

difference.” Id. at 70-71. In his note of October 20, 2009, Dr. Buttar stated petitioner was

“ecstatic” and the nursing staff was “celebrating” since petitioner was able to walk into the IV

suite and talk in a normal voice. Id. at 69. On October 21, 2009, petitioner received IV

treatment and hyperbaric oxygen therapy (“HBOT”). Id. at 79. On the same day, petitioner

called Dr. Buttar with complaints of seizing again and her voice going out. Id. at 67. Dr. Buttar

visited petitioner and gave her TD-DMPS,48 and eventually petitioner stated that she felt good.

Id.

On October 22, 2009, petitioner continued to have the ability to speak and walk and

underwent a quantitative electroencephalogram (“qEEG”). Id. Myra A. Preston,49 Ph.D.,

evaluated petitioner’s qEEG data and concluded petitioner’s left parietal and temporal regions

contained abnormal activity that should be further investigated. Id. at 87-89. During the time

that Ms. Preston thought petitioner was having a seizure, the qEEG recording consisted of

muscle artifact as petitioner had strong muscle contractions in her facial muscles. Id. at 88.

Then the “seizure” subsided and the qEEG returned to baseline. Petitioner applied a cream to

her forearms and the qEEG data began to appear more normal in the parietal and temporal

48

TD-DMPS stands for transdermal 2,3-Dimercaptopropane-1-sulfonate, which “is a metal chelator approved in

Europe for oral or intravenous use for heavy metal poisoning. Transdermally applied DMPS (TD-DMPS) is used by

some alternative practitioners to treat autism, despite the absence of evidence for its efficacy.” Plasma and urine

dimercaptopropoanesulfonate concentrations after dermal application of transdermal DMPS (TD-DMPS), 9 J MED

TOXICOL 9-15, at 9 (2013).

49

Ms. Preston has a website called www.siberimaging.com in which she states that she offers through qEEG and

neurofeedback enhancement of central nervous system functioning to promote peak performance, intelligence,

alertness, focus, strength, balance, positive mood, and awareness. She claims she and Kim Phillips, Clinical

Director, developed and patented this in 1993. SIBER IMAGING, WWW.SIBERIMAGING.COM (last visited Jan. 11,

2019). Ms. Preston claims success in training individuals with the following disorders: alcohol & substance abuse,

medical reduction & withdrawal, depression, post-traumatic stress disorder, panic disorder, obsessive compulsive

disorder, bipolar disorder, dementia, eating disorders, attention deficit disorder, attention deficit hyperactivity

disorder, adult attention deficit disorder, chronic fatigue syndrome/myalgic encephalomyelitis, various sleeping

disorders, fibromyalgia, post-viral syndromes, premenstrual stress syndrome, migraine headache, hypertension,

gastrointestinal dysfunction, bowel dysfunction, bladder dysfunction, heart rate regulation, chronic pain syndrome,

vulvodynia pain, dysautonomia, epilepsy seizure disorders, Tourette’s syndrome, tic disorder, autism, autism

spectrum disorders, brain injury, closed head injury, spinal cord injury, anoxic brain injury, and stroke. Id. Chronic

Fatigue Immune Dysfunction Syndrome (“CFIDS”) was the focus of Ms. Preston’s Ph.D. dissertation. Id. She

claims that the reasons CFIDS clients have normal EEG results on conventional EEGs is that they are done with the

client’s eyes closed. Ms. Preston does qEEGs on CFIDS clients with their eyes open, and gets an abnormal response

showing the clients have metabolic encephalopathy. Id. Ms. Preston received her doctorate in Psychophysiology in

1994 from The Union Institute. Id. The North Carolina Medical Board accused Ms. Preston of practicing medicine

without a license through her company Siber Imaging, and selling a BrainMaster “brain mapping machine.”

Medicine, COURTHOUSE NEWS SERVICE (Feb. 22, 2011), http://www.courthousenews.com/medicine-2.

26

regions for 10 to 15 minutes. However, neither region became completely normal. Ms. Preston

did not see any additional seizures and petitioner began to speak normally. Id. During the next

21 minutes, petitioner applied more of the cream and the qEEG maintained improvements. Id.

Ms. Preston characterized the one seizure as an absence seizure. Id. In addition, Ms. Preston

added that, in her experience, “the data acquired from the left temporal and parietal regions most

resemble data correlated with myoclonic seizures,” and went on to note that medical literature

identifies these types of findings with acute insults. Id. at 89. However, Ms. Preston also noted

that “this evaluation should not be considered diagnostic.” Id. at 87.

While seeking treatment at Dr. Buttar’s office, petitioner’s urine tests revealed high levels

of mercury, nickel, copper, lead, zinc, and manganese. Id. at 16-40. Petitioner’s urine test

revealed low levels of molybdenum. Id. at 42.

On October 30, 2009, petitioner visited Dr. Cintron for a neurological follow-up. Med.

recs. Ex. 1, at 13. She reported that she had been working in Charlotte with chelating therapy

and felt that she was making progress. Dr. Cintron thought petitioner had a minor seizure in his

waiting area but by using a compound that Dr. Buttar gave her, she dropped into her forearm and

was able to calm down. Her speech seemed somewhat easier to understand. Id. Dr. Cintron also

ordered an EEG, the result of which was normal. Id.

On December 7, 2009, petitioner saw Dr. Cosgrave again and her gait and speech had

“somewhat improved.” Med. recs. 45, at 2.

Also, on December 7, 2009, petitioner visited Dr. Randolph R. Stephenson, a neurologist.

Med. recs. Ex. 22, at 36-37. Petitioner stated that in September, she was hospitalized for

rhabdomyolysis following either a viral illness or flu vaccination. Afterward, she started

developing problems with walking and speech. She felt as though she had difficulty moving her

legs while walking, but “remarkably,” she had no problems running. Id. at 36. She had

problems with stuttering. She said numerous doctors suggested she might be having a stress

reaction and suggested she see a neuropsychologist. She was going to North Carolina for

chelation therapy, “although it is unclear what is being chelated.” Id. She reported that she was

having frequent “seizures” at the rate of around 60 per day, during which she would shake

frequently. She denied losing consciousness or having urinary incontinence during these

episodes. She did not appear to be having these episodes anymore at the same frequency. Id. at

36. Petitioner also reported that she continued to exercise regularly, but after running she

sometimes passed out. Id.

On physical examination, petitioner’s blood pressure was 166/86. Id. at 37. Dr.

Stephenson noted petitioner had normal cognition, comprehension, and vocabulary, but

frequently talked in a British or Australian accent. Id. Petitioner said it was part of the changes

in her speech. Id. She also had frequent stuttering. Petitioner had normal muscle bulk, strength,

and tone. Id. When Dr. Stephenson asked her to point or hold or write something, petitioner

would start shaking her head and hands vigorously. The tremor would be in several planes of

direction and was highly distractible. There was also a highly suggestible component to it so that

Dr. Stephenson could easily bring out the tremor just by having petitioner talk about it. She had

normal light touch, pinprick, temperature, and vibratory sensation. Her reflexes were 1 to 4 and

27

symmetric at the biceps, triceps, patellae, and ankles. Her toes were downgoing. Petitioner had

a “very clear” astasia-abasia gait when walking. Id. She would often appear off balance without

actually falling. When Dr. Stephenson watched her closely, he saw clearly that her balance was

actually better than average given some of the positioning her body took while walking. Id. Dr.

Stephenson’s stated he was not entirely sure what caused all of petitioner’s movement

complaints. However, he wrote she had “a very clear functional component to the majority of

her exam. There were no neurological findings that would suggest any particular organic disease

process.” Id.

On December 11, 2009, petitioner saw Dr. Sidney W. Binks, III, Ph.D., at the

recommendation of Dr. Christine Cosgrove, the clinical psychologist. Med. recs. Ex. 19, at 1.

Dr. Binks is a neuropsychologist and clinical psychologist. Id. While giving a history to Dr.

Binks, petitioner said that her MRI had been painful as if she were on fire. Id. at 2. She said that

looking at carpet patterns could cause her whole body to shake and a speech problem. She said

she was having 60 seizures a day. She reported great difficulty with fine motor coordination.

Her mental health history was positive for bulimia at age 13 for one year. She was currently in

psychotherapy with Dr. Cosgrove. Her sister had attempted suicide. Dr. Binks interviewed

petitioner on December 11, 2009 and evaluated her on December 19, 2009 and January 16, 2010

for about seven hours. Petitioner drove herself to and from the testing on both days. She did not

have any muscle contractions or involuntary movement as she entered or exited Dr. Binks’ office

on either testing day. However, on the day of the interview, she walked extremely awkwardly.

She could not walk forward but instead walked sideways. Dr. Binks interviewed her when she

was with her then-husband who often reported her history because she had difficulty speaking

and recalling. Id.

Petitioner frequently became frustrated during testing when she was asked to pronounce

words. She had muscle contractions and seemed to put great effort into producing the answer.

She also had a stutter. Her arm muscles and face muscles would simultaneously contract during

these times. Her right-sided muscle movement was more pronounced, including her arm and

face. The more frustrated she became, the more the muscle movements increased. Dr. Binks

did not observe these muscle contractions during general conversations. Her general speech had

somewhat of a British accent. Her volume would occasionally be high-pitched. Id.

Petitioner reported she had difficulty focusing on a page when asked to perform certain

tasks such as sentence comprehension, and she used a piece of blank paper with a small cut in

the middle to read line by line. She would spell a word out loud as she wrote it on the paper

because she indicated that made it easier. She said attempting to look at pages gave her a

headache. Id. Petitioner had great difficulty pressing her finger down on a button and had

muscle contraction increase in the finger tapping test. Id. at 3. Petitioner reported that some of

her physical complaints had lessened, but her speech and cognitive symptoms had recently

worsened. Id.

Dr. Binks also conducted a personality/psychopathology test in addition to the interview.

Id. Petitioner’s validity scales suggested that she was “uncomfortable acknowledging personal

faults” and presented herself in an extremely positive light by denying many minor faults and

28

shortcomings that most people acknowledge.” Id. Dr. Binks noted that “this level of virtuous

self-presentation is uncommon and likely resulted in an underestimate of personality-related

clinical findings.” Id. Dr. Binks stated that due to petitioner’s preoccupation with physical

health concerns, “she is likely prone to developing physical symptoms in response to stress.” Id.

at 4. Dr. Binks concluded, “Problems with her emotional life, thought process and behavior

could not be ruled out given the tendency to under-report even normal psychological

imperfections.” Id. Dr. Binks’ impression was that petitioner had weakened, but not impaired,

cognitive skills. Id. Dr. Binks believed that intensive speech and language evaluation/therapy

should be pursued, working on lowering petitioner’s expectations to realistic levels could be

helpful, and stress reduction techniques would be useful. Id. Although petitioner’s cognitive

skills were currently weakened, Dr. Binks did not consider them impaired but at functional

levels. He suggested psychotherapy to help lower her perfectionism to realistic levels. Dr. Binks

noted petitioner was under tremendous stress and he suggested stress reduction. He stated, “She

would do well to avoid the pull toward being a public spokesperson for others and instead focus

on her own wellbeing and rehabilitation. It is clear that stress exacerbates her symptoms.” Id.

On December 18, 2009, petitioner saw Dr. Cintron for a neurological follow-up. Med.

recs. Ex. 1, at 14. Petitioner’s gait and speech were better, but she still had difficulty walking

unless she walked sideways, and her speech tone changed during her visit. The EEG50 done in

Charlotte implied petitioner had epilepsy, but Dr. Cintron did an EEG himself and it was normal.

He looked at the Charlotte EEG with petitioner and did not see any abnormalities. Petitioner

“alleged” [Dr. Cintron’s verb] that her heart beat went to almost 200 when she exercised and Dr.

Cintron told her to stop exercising until she saw a cardiologist. He states, “Ultimately, this

appears to be a very complicated situation with post vaccination disorder. . . .” Id.

On December 18, 2009, petitioner saw Dr. Mark P. Tanenbaum at the Cardiovascular

Group, P.C., for a cardiology assessment for her increased heart beat while running. Med. recs.

Ex. 13, at 7. Petitioner said she received flu vaccine on August 23, 2009 and, within a couple of

weeks, she developed apparent flu-like symptoms, neurologic symptoms, and sensory symptoms.

She had some motor, gait, and speech abnormalities. She had an episode including syncope on

September 12th after eating. She was admitted to Loudoun Hospital which diagnosed her with

rhabdomyolysis. She was discharged on September 14th but readmitted on September 17th with

recurrent syncope. She was discharged, but she was readmitted with similar symptoms at Fairfax

Hospital on September 26th. She said she was told she may have GBS related to her flu

vaccination. She went to Johns Hopkins University Hospital and was treated with Ativan and

Klonopin. She had an EEG which was normal. She went to Charlotte, NC, for chelation therapy

to remove apparent excess mercury. She had been usually quite active, running three miles in 25

minutes. During the last several months, when she ran, her heart rate would increase more

quickly up to 180 beats a minute associated with fatigue. Id. In a review of systems, Dr.

Tanenbaum wrote petitioner denied any difficulty speaking. On physical examination, petitioner

did not have any gross motor or sensory deficits. Id. at 8. Dr. Tanenbaum’s impression was

50

This must be the qEEG that Ms. Preston did since there is no other EEG that petitioner underwent while staying in

North Carolina to receive evaluation and treatment from Dr. Buttar.

29

“apparent vaccination-induced motor disorder, along with apparent dystonic and myoclonic

features.” Id. Dr. Tanenbaum suspected that petitioner’s elevated heart rate represented sinus

tachycardia, which “might be exacerbated by her ongoing problem with apparent vaccination-

induced motor disorder, along with apparent dystonic and myoclonic features.” Id. at 8.

On December 21, 2009, petitioner had a stress echocardiogram. Id. at 11. Dr. Nick

Cossa concluded petitioner had a normal stress echocardiogram without evidence of ischemia.

She had a normal heart rate and blood pressure response to exercise, normal exercise capacity,

no chest pain, ischemic EKG changes, or left ventricular wall motion abnormalities with

exercise. She had a transient syncope after exercise secondary to neurocardiogenic hypotension.

Id.

On December 28, 2009, petitioner went to a follow up appointment with Dr. Cintron.

Med. recs. Ex. 1, at 15. He thought petitioner walked better and her speech was more fluid. She

still had an “accent” [quotation marks are by Dr. Cintron]. She sounded dystonic and still had

some occasional syncopal episodes although her blood pressure in Dr. Cintron’s office was fine.

Apparently, she had a syncopal episode while on a treadmill in the cardiologist’s office, but the

office felt she did not have arrhythmia. Petitioner found that Valium allowed her to run better

and she took it sporadically. She still had better heat intolerance to some extent, and she was

better with not being overwhelmed in a stimulating environment. Dr. Cintron concluded that

petitioner’s problem was vaccine related consisting of dystonia and possibly some autonomic

problem. Id.

On January 19, 2010, petitioner saw Dr. Cintron. Med. recs. Ex. 1, at 9. She seemed

better. She had learned that with pain in her left quadriceps, she was able to walk better because

she got distracted. She also learned that by looking to the left, she could walk straighter.

Petitioner’s speech was significantly better that day. Dr. Cintron thought petitioner had some

type of dystonia related to her insult and he did not believe her situation was functional,

“although certainly there is some bizarre aspects to her disease.” Id.

On February 5, 2010, Dr. Cintron had petitioner undergo a Transcranial Doppler because

of her vertigo/dizziness and vertebrobasilar51 syndrome. Med. recs. Ex. 1, at 22. The result was

normal. He also checked her carotid arteries for stenosis52 because of transient ischemic attacks.

Id. at 23. The result was no significant stenosis in the right internal carotid artery and minimal 1-

15% stenosis in her left internal carotid artery. Both external carotid arteries had no significant

stenosis. Id.

On February 5, 2010, petitioner went to the Reston Hospital ED, complaining of

vomiting. Med. recs. Ex. 50, at 5. This started the day before. Id. at 6. Petitioner said she felt

dizzy on standing and had increased thirst. On physical examination, her motor exam was

normal in all extremities and her sensory exam intact. She had no abnormalities on the

cerebellar exam. Her cardiac rate and rhythm were normal. Her extremities were normal.

Petitioner told Dr. David Kruse that she had autonomic dysfunction after a flu shot. Id.

51

Vertebrobasilar pertains to vertebrae and arteries. Dorland’s at 2051.

52

Stenosis is “an abnormal narrowing.” Dorland’s at 1769.

30

Petitioner had driven herself to see Dr. Cintron that morning and “developed a syncopal episode

with thickened speech with a British accent and inability to walk.” Id. at 12. Her glucose was

low at 73 when the normal range is 74-106 mg/DL. Id. at 19. Dr. Kruse diagnosed petitioner

with clinical dehydration and discharged her. Id. at 7.

On February 8, 2010, petitioner went to Inova Fair Oaks Hospital Rehabilitation Center

Speech-Language Pathology (SLP) for an evaluation, to which Dr. Cintron sent her. Med. recs.

Ex. 17, at 7. The onset of petitioner’s speech difficulty was noted as September 3, 2009. The

history was that petitioner developed an adverse reaction to a flu vaccination, and was

hospitalized for seizures and decreased ambulation. She also developed vasodepressor syncope

and reported a decrease in speech manifesting as stuttering, foreign accent, and blocks. She

stated she had a decrease in doing simple math and in memory. Id. The assessment was

moderately severe cognitive, language processing/mild speech production disorders. Processing

deficits were noted for combined modalities. She had significant breakdowns in attention skills,

including selective and divided. This impacted her ability to complete basic routines of activities

of daily living (“ADLs”). When petitioner’s cognition, processing, and attention are challenged,

this impacted her verbal expression complicated by dysfluencies/blocks. Id. The pathologist

(whose signature is illegible) wrote petitioner would benefit from skilled speech therapy

intervention to improve her cognitive skills for ADLs. Id. As part of petitioner’s evaluation, the

therapist noted petitioner spoke English with an Australian accent and when stressed, her speech

became extremely dysarthric with spasmodic head movements which the therapist diagnosed as

transient neurogenic stuttering brought on by stress, cognitive stress vs. distraction and auditory

distraction. Id. at 8. During more testing on February 15, 2010, the therapist noted that

petitioner was able to jog in place to “refresh” herself with more normalized speech afterwards.

Id. at 9. On March 15, 2010, the therapist noted that a low dosage of Valium appeared to

facilitate petitioner’s ability to tolerate multi-modal stimulation and function more optimally. Id.

at 5.

On February 12, 2010, Dr. Cintron sent petitioner to Cardiovascular Group again.

Petitioner saw Dr. Pradeep Nayak. Med. recs. Ex. 13, at 4; Ex. 53, at 66. Dr. Nayak diagnosed

petitioner with vasodepressor53 syncope, demonstrated following her stress echocardiogram

about six weeks previously. Med. recs. Ex. 12, at 5. He also diagnosed her with “apparent

vaccination-induced motor disorder,” elevated heart rate early in exercise, mild rhabdomyolysis

in 2009, and a leg injury with desire to return to running. Id. He recommended she see Dr.

Walter L. Atiga.

On February 23, 2010, petitioner saw Dr. Cintron. Med. recs. Ex. 1, at 8. Her speech

was mildly impaired with mild dystonic-type filter. Dr. Cintron found that her

neuropsychological testing was somewhat confusing in his interpretation. He thought it

interesting that when petitioner exercised, she did better.

53

Vasodepression is a “decrease in vascular resistance with hypotension.” Dorland’s at 2027.

31

On February 26, 2010, Dr. Cosgrave, petitioner’s psychologist, mailed a letter to

petitioner’s former attorney. Ex. 11, at 1, and Ex. 45, at 2. She states that the extent of

petitioner’s impairments was beyond her scope of expertise. Id.

On March 2, 2010, petitioner underwent a brain MRI for foreign accent syndrome.54

Med. recs. Ex. 53, at 68. Dr. Arun Kumar compared the results with petitioner’s brain MRI,

done October 3, 2009. Petitioner’s ventricles, sulci, and cisterns were normal for her age. She

did not have hydrocephalus, abnormal signal intensity in the brain parenchyma, hemorrhage,

mass, mass effect, or midline shift. She did not have evidence of restricted diffusion to suggest

an acute or subacute infarction. Her mesial temporal lobe structures were symmetric. She did

not have evidence of cortical dysplasia. Her flow voids were maintained. There was mucosal

inflammation in the mastoid sinuses, ethmoidal air cells, and frontal sinuses. Her orbits were

normal. Her mastoid air cells were clear. Dr. Kumar’s impression was petitioner did not have an

acute intracranial process and she had mild sinus disease. Id.

On March 3, 2010, petitioner underwent a F-18 FDG PET/55CT scan of her brain for

cognitive impairment and foreign accent syndrome. Id. at 69. Dr. Stuart A. Fruman compared

the results with petitioner’s brain MRI, done on October 2, 2010. Petitioner had symmetric

distribution of FDG metabolism through her brain parenchyma. She did not have any abnormal

areas of increased or decreased isotope accumulation. Dr. Fruman wrote petitioner had a normal

brain PET/CT scan. Id.

On March 16, 2010, petitioner and her then-husband saw Dr. Cintron. Med. recs. Ex. 1,

at 7. Petitioner’s PET scan was normal. He told petitioner and her then-husband that he had not

seen any evidence of any irreversible changes to any part of her central nervous system and he

felt confident she would recover. At this point, he empirically labeled petitioner as having

dystonic-type illness with other “not very well explained features and possible autonomic

dysfunction secondary to her vaccination.” Id. She seemed to have an exaggerated vasovagal

syndrome because she faints after eating and exercising. Dr. Cintron states, “From the

neurological perspective the symptoms are still bizarre, she has an accent which fluctuates, she is

able to walk sideways but not forward, but no objective evidence on exam of where the problems

are coming from.” Id.

On March 23, 2010, petitioner saw Dr. Atiga, a cardiologist, for an evaluation and

management of syncope. Med. recs. Ex. 13, at 1. Dr. Nayak referred petitioner to Dr. Atiga for

54

“Foreign accent syndrome (FAS) is speech disorder that causes a sudden change to speech so that a native speaker

is perceived to speak with a ‘foreign’ accent. FAS is most often caused by damage to the brain caused by a stroke or

traumatic brain injury. Other causes have also been reported including multiple sclerosis and conversion disorder

and in some cases no clear cause has been identified.” What is Foreign Accent Syndrome?, THE UNIVERSITY OF

TEXAS AT DALLAS, https://www.utdallas.edu/research/FAS/ (last visited Jan. 25, 2019).

55

Positron emission tomography (PET) is “tomography accomplished by detection of gamma rays emitted from

tissues after administration of a natural biochemical substance (e.g., glucose, fatty acids) into which positron-

emitting isotopes have been incorporated. The paths of the gamma rays, which result from collisions of positrons

and electrons, are interpreted by a computer, and the resultant tomogram represents local concentrations of the

isotope-containing substance.” Dorland’s at 1935. FDG is 18fluorodeoxyglucose. Neil M. Davis ed., MEDICAL

ABBREVIATIONS 144 (12th ed. 2005) [hereinafter “Med. Abbrev.”].

32

management of vasovagal syncope. Petitioner stated she was healthy and active as a runner until

she started having problems late summer 2009. She received flu vaccine for the third year in a

row. A couple of weeks later, she started having recurrent episodes of syncope preceded by

lightheadedness, warmth, and cold hands and feet. These would always occur soon after eating.

The symptoms got so bad she would take a sip of water and then pass out, having nausea and

vomiting afterwards. She went to Loudoun Hospital, and then Johns Hopkins, but was not able

to get a clear and definitive diagnosis. She was featured on the local channel 5 news because she

thought her symptoms were due to flu vaccine. Having read that news story, an organization that

believes vaccines may cause autism contacted her because her symptoms could be consistent

with mercury toxicity. As a result, she went to North Carolina and underwent chelation

treatment because of elevated levels of mercury. The chelation therapy helped her feel better,

but since it was prohibitively costly, she could not continue with it.

Presently, petitioner discovered that if she exercised, such as went running, she could eat

without becoming nauseated, vomiting, or passing out. On days when she did not run, she had

presyncope or syncope. She tore her left quadriceps and could not run. Since then, she has had a

recurrence of symptoms so that she cannot eat without passing out. She is very sensitive to heat

and, if she goes out on a warm day, she has lightheadedness, warmth, presyncope, syncope,

nausea, and vomiting. Her then-husband hugged her tightly and compressed her neck at one

point, and she passed out and had seizure-like activity. She had the same symptoms while

undergoing a carotid Doppler examination. At her worst, she was unable to walk forward but

could walk sideways or backward. However, when she began taking Neurontin56 and after the

dosage was increased, she was able to walk forward. Another “interesting” symptom was that

she developed what sounds like a British accent although she is from Ohio. Id. at 1. She

increased her salt intake by 2,000 mg of sodium and increased her fluids, but they did not have

an effect. Id. at 1-2. Under job description, Dr. Atiga wrote professional cheerleader. Id. at 2.

Dr. Atiga’s impression was that petitioner’s symptom complex “does certainly time out

with her receiving the flu vaccination.” Id. Her symptoms were consistent with a vasovagal or

neurocardiogenic mechanism. He writes, “It is interesting that on days when she has heavier

physical exertion, her symptoms are improved enough that she can actually eat,” but on days

when she does not do this, her symptoms are worse. She also seemed to have evidence of carotid

sinus hypersensitivity. Dr. Atiga writes, “I believe that she has an unusual form of

neurocardiogenic syncope in that she has very heightened vagal tone and the reason that the

exercise improves her on that day is because it increases her sympathetic tone.” Id. To reduce

petitioner’s vagal tone, Dr. Atiga offered her either a Scopolamine57 patch or Norpace.58 Either

56

Neurontin is “trademark for preparations of gabapentin.” Dorland’s at 1268. For a definition of gabapentin, see

supra, n.8.

57

Scopolamine is “an anticholinergic alkaloid, derived from several solanaceous plants, including Atropa

belladonna, Hyoscyamus niger, Datura species, and Scopolia species. It has effects on the autonomic nervous

system similar to those of atropine. It is used as an antiemetic, particularly in motion sickness.” Dorland’s at 1681.

58

Norpace is “trademark for preparations of disopyramide phosphate.” Dorland’s at 1291. Disopyramide is “a

cardiac depressant with anticholinergic properties, used as an antiarrhythmic.” Id. at 547. An antiarrhythmic is “an

agent that prevents or alleviates cardiac arrhythmia.” Id. at 100.

33

drug would put her parasympathetic and sympathetic tone in more balance. He prescribed

Norpace. Id.

On March 25, 2010, petitioner saw Dr. Cintron. Med. recs. Ex. 1, at 6. He states she is a

very pleasant woman whom he follows for neurological implications secondary to exposure to a

flu vaccine. She was doing significantly better since he increased her Neurontin to 200mg twice

a day. She could walk forward. Her voice sounded much better. but she still had some difficulty

eating unless she exercised. She was working with Dr. Atiga to help with her dysautonomia. Id.

Throughout February and April 2010, petitioner sought treatment at the Physical

Medicine and Rehabilitation unit at Inova Fair Oaks Hospital. Med. recs. Ex. 53, at 41-59.

Petitioner sought cognitive treatment that focused on processing multiple stimuli simultaneously

and tuning out extraneous stimuli. Id. at 41. Through a hierarchy of graduated attention tasks

and possibly a change in medications to help control her dystonia, Wendy Morgan, MS, CCC-

SLP, wrote that petitioner had made significant gains in all cognitive areas. Petitioner was

discharged because she moved out of the area. Id.

On May 21, 2010, petitioner saw Dr. Cintron. Med. recs. Ex. 1, at 5. Petitioner was

trying to control her syncopal episodes that occurred when she was overheated. She seemed to

be somewhat able to prevent them by exercising excessively as if she were trying to get her

adrenaline going. Petitioner was seeing Dr. Atiga to see if she could get help with what appeared

to be autonomic imbalance. From a neurological perspective, petitioner continued to have

dystonia and speech difficulty, but had significantly improved over time. She was getting ready

to move to California. Id.

On May 24, 2010, petitioner saw Dr. Farhad Zangeneh for an endocrine evaluation.

Med. recs. Ex. 43, at 28. Petitioner was on disability and wanted Dr. Zangeneh to evaluate her

adrenal gland, thyroid, and overall endocrine status. Id. A comprehensive metabolic test result

was normal. Id. at 29. Dr. Zangeneh wrote that petitioner’s blood pressure both sitting and

standing was nearly identical, and she did not have orthostatic hypotension. Petitioner was on

Depo-Provera. Dr. Zangeneh discussed with petitioner that, from an endocrine standpoint, he

did not recommend Depo-Provera because of an increased risk for bone loss and for the

development of metabolic syndrome. Id. On June 4, 2010, Dr. Zangeneh informed Dr. Ho that

petitioner’s lab results were normal and there was no endocrine etiology for petitioner’s

symptoms. Id. at 27.

On July 2, 2010, after petitioner moved to California, she saw Dr. Neil Q. Tran as her

new PCP, at the Mission Internal Medicine Group. Med. recs. Ex. 42, at 28. In his note, Dr.

Tran listed multiple problems including petitioner’s intolerance to heat over 75oF, anxiety,

dystonia, autonomic dysfunction, dizziness, fatigue, diarrhea, and facial weakness. Id.

On July 2, 2010, petitioner began keeping a log of events and blood sugar readings. Med.

recs. Ex. 42, at 26. She noted that on July 1, 2010, she last engaged in 30+ minutes of aerobics

at noon. On Friday, July 2, 2010, she did not have any trouble all day eating or drinking. On

Saturday, July 3, 2010, she became nauseated, dizzy, and unable to walk and talk after breakfast.

This continued throughout the day at every meal. Later in the day, meals resulted in diarrhea.

34

On Sunday, July 4, 2010, she had very little appetite. Water now triggered her symptoms.

Immediately after eating breakfast, she went into the hyperbaric chamber to stop her symptoms.

She ate a peach and chicken with water. She became unable to walk or talk, became dizzy, had a

headache, chest pain, and an upset stomach. She found the smell of food disgusting. She had an

upset stomach upon drinking sips of water. She was dizzy when she got out of bed quickly. She

had stomach pain. On Tuesday, July 6, 2010, she had a breakfast sandwich with apricots, a bagel

with cream cheese and salmon, a pomegranate smoothie, and a small bowl of cereal with almond

milk. She lost the ability to walk and talk, and had a painful headache upon simply sipping water

if not allowed to lie down. She ate all her meals lying down. Her blood sugar was 100mg/dl

before breakfast right after waking up, 117mg/dl ten minutes after eating breakfast, 203mg/dl

two hours after eating, 92mg/dl at 2:51 p.m., and 82mg/dl at 7:29 p.m., which was two hours

after eating. On Wednesday, July 7, 2010, she had a breakfast sandwich with apricots. She lost

the ability to walk and talk, and had a headache when not able to lie down. She was extremely

tired. She slept most of the morning. She felt she might be coming down with a cold because

she had a sore/swollen throat, felt weak, and had a heavy chest for the prior couple of days. She

had a lot more irritability with throbbing pain in her teeth. Her blood sugar was 82mg/dl before

breakfast right after waking up, 99mg/dl two hours after eating, 125mg/dl at 4:45 p.m., and

97mg/dl before going to bed at 8:47 p.m. Id.

On July 12, 2010, petitioner was tested for levels of epinephrine and norepinephrine in

her urine. The results were reported on July 16, 2010. Med. recs. Ex. 42, at 41. Her total was

low at 1559 when normal should be 26-121.

On July 15, 2010, Dr. Atiga conducted a tilt-table test. Med. recs. Ex. 23, at 1. Upon

upright tilt, petitioner immediately developed slurred speech that progressively worsened over

the next 15 minutes so that she could not speak at all. This occurred despite her having normal

peripheral blood pressure and heart rate. She was then provoked with 0.4mg sublingual

nitroglycerin and, shortly thereafter, she became dystonic, progressing to more severe dystonia,

with tonic/clonic movements without loss of consciousness. Her blood pressure was 169/123

with a heart rate of 120 beats per minute. She was laid flat with her legs elevated. Petitioner had

rapid resolution of dystonia, but her slurred speech persisted for nearly one hour. Id. Dr. Atiga

wrote petitioner might have a form of cerebral syncope in which she had dysregulation of

cerebral blood flow to upright posture, especially with orthostatic stress. Id. at 2.

On August 4, 2010, petitioner saw Dr. Frisca Yan-Go, a neurologist, at UCLA Health

System on the recommendations of Dr. Cintron and Dr. Atiga. Med. recs. Ex. 18, at 2.

Petitioner saw Dr. Yan-Go for dysautonomia, the main component of which was syncopal attack

when standing, but also inability to eat or drink without her body expelling food or liquid. She

needed to engage in 10 minutes or more of aerobic activity before she could tolerate eating.

59

Low levels of epinephrine and norepinephrine can contribute to a variety of physical and mental conditions,

including: anxiety, depression, fibromyalgia, hypoglycemia, migraine headaches, restless leg syndrome, and sleep

disorders. Chronic stress, poor nutrition, and taking certain medications, such as methylphenidate (Ritalin) can

make someone produce less epinephrine and norepinephrine. What’s the Difference Between Epinephrine and

Norepinephrine?, HEALTHLINE NEWSLETTER, https://www.healthline.com/health/epinephrine-vs-norepinephrine

(last visited Jan. 8, 2019).

35

Once she stopped exercising, she could not eat and quickly lost weight and became severely

dehydrated. She is very intolerant to heat and humidity. She cannot lift her legs to walk, her

speech becomes slurred and she has nausea, dizziness, and profuse sweating. After eating, she

gets very dizzy. Sometimes, when she has to talk or gets short of breath with chest pain, this

triggers a dystonic reaction in which her jaw tightens, she slurs her words, and she adopts

abnormal positioning of her extremities, all while she is conscious. She had a tilt-table test on

July 15th and apparently her blood pressure did not change much, but her heart rate increased

from 70 to 125, and she had presyncope, resulting in stopping the test. Id.

Dr. Yan-Go went through petitioner’s history. She received her first flu shot in October

2007 and had flu symptoms. She received her second flu shot in October 2008 and developed a

flu and bronchitis pneumonia 30 days after the shot. On September 3, 2009, she had her third

seasonal flu shot [this is incorrect; her flu vaccination in 2009 occurred on August 23, 2009; Dr.

Yan-Go is basing this history on petitioner’s recounting her history to her]. Petitioner said she

had total body aches and fatigue. Nine days later, on September 12, 2009, she could not move

much, was very fatigued, and went to the hospital which said she had increased creatine kinase

and diagnosed her with rhabdomyolysis. On September 17, 2009, she saw an infectious disease

specialist who thought she might have Lyme disease. Her speech got worse and she felt fatigued

and weak. In retrospect, they thought she might have a form of postinfectious GBS.

On September 27 and 28, 2019, petitioner had low orthostatic tolerance and orthostatic

hypotension, but not a full faint. By October, she had to lie down most of the time. In December

2009, she fainted again. In March 2010, she saw an endocrinologist and other specialists who

said she might have a form of GBS-like symptoms which triggered a dysautonomia. The

dysautonomia fluctuated in intensity intermittently. She could not change position from sitting

or bending to standing without being dizzy or fainting. Norpace controlled it 60 percent. She

cannot hold her breath for more than five seconds without becoming dizzy and then she loses

some speech and the ability to walk. Even at 75 degrees in temperature, she has extreme fatigue

and then chest pain and headache especially when she was walking and standing. She slept quite

well and sometimes had to sleep for 10 hours at night and four hours in the day. Id.

She gets depressed if she cannot exercise. She cannot tolerate stress without sharp chest

pain, slurred speech, weakened muscles, and dizziness. She has extreme difficulty eating and

consuming or retaining water if she cannot complete 10 to 20 minutes of exercise like running,

biking, rowing, or stair stepping. Then her symptoms would return and she could not tolerate

food. She cannot control her leg muscles without Neurontin. Sometimes, she can soothe the

dystonia with a sensory trick like touching her left eye. She cannot tolerate multiple noises,

sounds, or flashing lights, which result in a “violent convulsion,” but she has 90 percent control

with low-dose Neurontin. She cannot multitask and has intermittent difficulty speaking, which

speech therapy did not improve. Id. Many times, she has extreme difficulty with cognition

concerning calculating, remembering things, strategizing, and recalling, but she did not mention

whether she improved in a supine position from being upright. Id. at 2-3. Her Epworth

Sleepiness Scale was 15, with normal being less than 9. Id. at 3. She has been observed to have

36

sleep talking and sleep walking. Her Beck Inventory60 is rated slightly elevated at 14 with

normal being less than 9. Id.

On physical examination, Dr. Yan-Go notes that petitioner was not orthostatic. Id. at 3.

Dr. Yan-Go hyperventilated her for only 10 seconds. Her eyes looked glassy, but she was still

conscious and then she went into almost a tetany61 state. Her jaw locked and her extremities

went dystonic for about 10 to 15 seconds. Dr. Yan-Go told her to close her mouth and stop

hyperventilating. Petitioner then came back to baseline in 30 seconds. Dr. Yan-Go wrote this

was more of a tetany reaction to respiratory alkalosis and not the usual chronic dystonic

syndrome because petitioner did not have dystonic posturing in baseline except when she was

being hyperventilated. Dr. Yan-Go put petitioner on a bed and was able to get her to breathe

very slowly. She was able to breathe about 20-30 seconds without dystonic posturing if she

breathed slowly and was recumbent. Id. Dr. Yan-Go noted petitioner did not have Raynaud’s

phenomenon62 and had some increased sweating while she was hyperventilating.

In her assessment, Dr. Yan-Go writes:

This is a very complex set of symptomatology. It is very hard to

put it all together, but the way I analyze it is that she is born with

normal nervous system and autonomic nervous system.

Id.

On August 25, 2010, petitioner saw Dr. Yan-Go again. Id. at 1. Dr. Yan-Go states

petitioner “has a very complex symptomatology, many of which I cannot explain by unified

disorder.” Id. Dr. Yan-Go thought petitioner’s tilt-table test was interesting because when she

was tilted, she had dystonic posturing and slurred speech. Dr. Yan-Go thought petitioner had

some symptoms of orthostatic intolerance or maybe POTS, and might have some presyncopal

phenomena, but not full syncopal phenomena. If petitioner did not exercise vigorously for 30

minutes, she could not get a sip of water or a bolus of food without having slurred speech and

she would get very dystonic and fall. She had neurologic testing, imaging, and neuropsychologic

testing without a diagnosis. She was referred to Dr. Yan-Go for dysautonomia. Dr. Yan-Go said

she would not be able to explain all of petitioner’s symptoms such as walking sideways or else

she gets dystonia. Dr. Yan-Go observed all these events that day in her office. Petitioner took

herself off Neurontin and Norpace in the prior two weeks because she had to do that before

undergoing autonomic testing. She told Dr. Yan-Go that she could not tolerate the heat because

she is intolerant of heat and cold temperatures and barometric pressure. Petitioner could not

60

Beck Depression Inventory is “a self-report questionnaire for measuring the symptoms of depression, focusing on

the cognitive symptoms.” Dorland’s at 955.

61

Tetany is “hyperexcitability of nerves and muscles due to decrease in concentration of extracellular ionized

calcium, which may be associated with such conditions as parathyroid hypofunction, vitamin D deficiency, and

alkalosis or result from ingestion of alkaline salts; it is characterized by carpopedal spasm, muscular twitching and

cramps, laryngospasm with inspiratory stridor, hyperreflexia, and choreiform movements.” Dorland’s at 1904.

62

Raynaud’s phenomenon is “intermittent bilateral ischemia of the fingers, toes, and sometimes ears and nose, with

severe pallor and often paresthesias and pain, usually brought on by cold or emotional stimuli or anatomical

abnormality.” Dorland’s at 1430.

37

swallow one gulp of water in front of Dr. Yan-Go without exercising for 30 minutes. Then she

got dystonic speech. Dr. Yan-Go wrote, “I am really out of ideas today and so I said if she needs

to resume her Neurontin and Norpace so that she could eat and exercise 30 minutes but not

hyperventilate so she would not faint,” she could do so. Dr. Yan-Go suggested petitioner see a

gastroenterologist and take some swallowing tests and motility63 testing to determine if she has

dysmotility of the GI tract. Dr. Yan-Go said she “entertained” the idea that petitioner might have

dysautonomia, but Dr. Yan-Go observed petitioner did not have seizures because petitioner could

talk, this was gradual, and petitioner came back with no change of her sensorium. In addition,

petitioner had an EEG during these spells and the EEGs were normal. “I am worried whether

this also has some functional overlay and subconscious effect of conversion reaction or not.” Id.

Dr. Yan-Go stated it was very difficult, and whether petitioner had true triggers for movement

disorder, dystonic movement was “very very hard to differentiate.” Id.

On August 26, 2010, petitioner saw Dr. Kevin Ghassemi, a gastroenterologist, at UCLA.

Id. at 8. Petitioner complained that she would vomit if she had not exercised for 30 minutes prior

to eating. Id. However, if she exercised for 30 minutes, she was able to swallow solid food and

liquid for the next 24 hours. Id. In addition, she felt a sense of throat constriction, dizziness,

sweating, chest discomfort, and some slurring of her speech. Id. Petitioner reported that even

drinking water could immediately lead to slurring of speech. Id. Dr. Ghassemi reviewed her

laboratory testing. Petitioner had a normal C-peptide, morning cortisol level, metabolic panel,

lipid panel, and renin-angiotensin-aldosterone64 labs. Her ACTH level was slightly below the

reference range. Id. On physical examination, when Dr. Ghassemi palpated petitioner’s carotid

arteries, she developed slurred speech which immediately improved on lying in the supine

position. Id. at 9. She had a normal gait except for an episode of slurred speech when she

appeared to have unsteadiness. When she developed episodes of slurred speech during carotid

palpation and when she provoked symptoms by drinking water, she had twitching of her eyes

and lips, was unable to stick out her tongue, and had unsteady gait. Id. Dr. Ghassemi’s

impression was, “Dysphagia65 and vomiting in the setting of a complex group of symptoms.” He

found no reason to conclude petitioner had a structural gastrointestinal abnormality, given that

she experienced periods of tolerating both solids and liquids without dysphagia. He stated

petitioner might have a motility disorder but in the setting of her other symptoms, “it is unlikely

that she has a primary gastrointestinal motility disorder.” Id.

On August 30, 2010, petitioner returned to Dr. Ghassemi after undergoing esophageal

manometry66 and an upper GI series, both of which were normal. Id. at 11. Both tests provoked

a feeling of dysphagia and nausea. Since her manometry, after each meal, within 10 to 15

minutes, petitioner began to experience diarrhea while she was lying down. Subsequently, while

she was sitting to defecate, she would start to vomit. She recalled having similar problems

63

Gastric motility is “the spontaneous movements of the stomach muscles that grind food and mix it with gastric

secretions, and move the products into the duodenum.” Dorland’s at 1182.

64

Renin-angiotensin-aldosterone system (RAAS) is “the regulation of sodium balance, fluid volume, and blood

pressure by renal secretions.” Dorland’s at 1862.

65

Dysphagia is “difficulty in swallowing.” Dorland’s at 579.

66

Manometry is “the measurement of pressure by means of a manometer.” Dorland’s at 1104. A manometer is “an

instrument for measuring the pressure or tension of liquids or gases.” Id.

38

lasting about four days when she took an SSRI67 for her symptoms. She worried about becoming

dehydrated. On physical examination, petitioner went in and out of speaking with a British

accent. Petitioner asked Dr. Ghassemi if she had postprandial68 hypotension and he said he

could not find in the literature a specific controlled way of making this diagnosis. Dr. Ghassemi

assumed petitioner had an underlying neurologic disorder, “possibly related to autonomic

dysfunction” without evidence of esophageal dysmotility. Id.

On September 9, 2010, petitioner had an evaluation of autonomic disorder at The Ohio

State University Department of Neurology. Med. recs. Ex. 13, at 13 and Ex. 37, at 1-2. The tilt

test findings were consistent with grade II orthostatic intolerance or POTS. Med. recs. Ex. 37, at

2. The technologist conducting the test commented that petitioner “experienced symptoms of

feeling hot, focused in her upper trunk and head, with slight diaphoresis.69 The patient’s hands

and feet were cold and moist to the touch.” Id. at 1. Dr. Sheri Hart wrote that the tilt test

findings were consistent with Grade II Orthostatic Intolerance (Postural Orthostatic Tachycardia

Syndrome). Id. at 2. Petitioner’s heart rate-deep breathing study was normal. Her blood

pressure and pulse pressure were normal, but variable during 15 minutes of orthostatic stress.

Her heart rate variability in response to deep breathing was normal. Id.

On September 14, 2010, petitioner saw Dr. Yan-Go. Med. recs. Ex. 18, at 6. Dr. Yan-Go

reviewed Dr. Kevin Ghassemi’s complete GI test. Petitioner did not have a structurally

abnormal GI problem and no true dysfunctional GI problem in motility. Dr. Yan-Go’s opinion

was that petitioner did not have a serious, pure, autonomic failure or degenerative dysautonomia.

Dr. Yan-Go was confident that she could treat petitioner’s symptoms to prevent deconditioning

and prevent chronic patterning in her brain that might lead to further disability. Dr. Yan-Go

listed two choices. First, petitioner could have another full diagnostic study at the Mayo Clinic,

but the clinic cannot manage her treatment. Second, she can manage each symptom locally. Dr.

Yan-Go suggested nutritional management and directed petitioner to the website mypyramid.gov

to look at a high-protein, complex-carbohydrate, nutrient-dense diet with fluids and small

feedings. Dr. Yan-Go said petitioner had to condition her nervous system. She told petitioner

not to do aerobic exercises. Dr. Yan-Go preferred petitioner do aquatic exercise in an indoor

pool with controlled light, humidity, and temperature. Dr. Yan-Go said petitioner might have to

repattern her brain by seeing a psychologist for repatterning or cognitive behavioral therapy. She

also had to have proper sleep. Id.

On October 4, 2010, petitioner saw Dr. Robert A. Wohlman at NW Gastroenterology

Associates with the chief complaint of postprandial hypotension. Med. recs. Ex. 42, at 16.

Petitioner stated that “whenever she eats, within 15 minutes she becomes allergic, dizzy,

diaphoretic, and sweaty.” Id. Petitioner had to have her feet elevated after eating to help control

her symptoms. He described petitioner’s medical condition as “unusual.” Id. Petitioner said she

developed a “huge amount of neuropathy” after having a flu shot several years previously. Id.

Petitioner did not have any anorexia, weight loss, fever, musculoskeletal complaints, or other

67

SSRI stands for selective serotonin reuptake inhibitor. Dorland’s at 1759.

68

Postprandial means after a meal. Dorland’s at 1502.

69

Diaphoresis is sweating. Dorland’s at 509.

39

gastrointestinal or systemic complaints. Id. However, under review of systems, Dr. Wohlman

listed petitioner complained of diarrhea, abdominal pain, constipation, nausea, vomiting, and

getting full quickly at meals. Id. at 17. Petitioner’s gait was normal and she could undergo

exercise testing and/or participate in an exercise program. Id. at 18. Petitioner’s memory was

intact for recent and remote events. Dr. Wohlman’s assessment was that petitioner had

autonomic dysfunction manifested especially postprandially. Id.

On October 28, 2010, petitioner saw Dr. Cintron, her neurologist. Med. recs. Ex. 1, at 2.

Her voice and walking were better. Her problem continued to be memory and decompensating

when she tried to work hard cognitively. In addition, she had fainting episodes when she ate. Id.

On December 15, 2010, petitioner saw Dr. Daniel V. Wilkinson Jr., a cardiologist at

Swedish Medical Center. Med. recs. Ex. 12, at 3. Under history of present illness, he wrote

petitioner had a very unfortunate history of a profound immunologic reaction to a flu shot,

resulting in autonomic dysfunction which she characterized as POTS. She responded reasonably

well to Norpace. She subsequently developed profound postprandial hypotension. She

manifested virtual collapse with loss of speech and was placed on Sandostatin70 intramuscularly,

causing “a dramatic improvement.” Id. Petitioner was extremely heat intolerant and reported

that if she walked into a heated building, her blood pressure would drop and she would become

presyncopal. She did not have a history of palpitations. Id.

On January 14, 2011, petitioner saw Dr. Cintron, who noted that petitioner was able to

walk better, run better, and tolerate food significantly better. Med. recs. Ex. 1, at 1. Dr. Cintron

stated the biggest cognitive problem petitioner still had was speaking in her accent which was

more prominent, and cognitive function when she was in a hot temperature and standing,

compared to when she was lying down. Id.

On February 3, 2011, Dr. Cintron wrote a medical summary. Med. recs. Ex. 26, at 1. He

states, “In summary, her medical and neurological situation has been at best confusing and very

difficult to intellectually define.” Id. He concludes that her main physiological pathology

involved her autonomic nervous system and regulation of cerebral blood flow, resulting in

extreme sensitivity to collapse and fainting for which she tried to compensate by exercising

“almost to a pathological amount” and taking medications to augment vasomotor tone. Id.

Because of ongoing cerebral hypoperfusion, she developed cognitive processes and issues which

fluctuated and changed her intonation. Dr. Cintron states, “I don’t know if these particular

problems are related to the initial insult, versus ongoing cerebral hypoperfusion. All of this is in

my opinion is casually [sic] related to her flu vaccination, which is not unknown to cause post-

70

Sandostatin is “trademark for preparations of octreotide acetate.” Dorland’s at 1667. Octreotide is “an eight-

amino acid synthetic analogue of somatostatin, having actions similar to those of somatostatin but having a

prolonged duration of effect.” Id. at 1312. Octreotide acetate is “the acetate salt of octreotide, used as a treatment

adjunct for the palliative treatment of diarrhea associated with gastrointestinal endocrine tumors.” Id. Somatostatin

is “any of several cyclic tetradecapeptides elaborated primarily by the median eminence of the hypothalamus and by

the delta cells of the pancreatic islets; they inhibit release of growth hormone, thyrotropin, and corticotropin by the

adenohypophysis, of insulin and glucagon by the pancreas, of gastrin by the gastric mucosa, of secretin by the

intestinal mucosa, and of renin by the kidney.” Id. at 1735.

40

vaccination neuropathies, which can present with autonomic instability.” Id. He goes on to state

that petitioner is not able to be gainfully employed and is totally disabled. Id.

On February 3, 2011, petitioner saw Dr. Wilkinson. Med. recs. Ex. 12, at 1. Petitioner

continued to deal with abnormal neurovascular activity with symptomatic hypotension. She was

taking very potent medications. She had multiple “very unusual symptoms” including changes

in her speech and language patterns associated with presumed drop in blood pressure. Her

exercise tolerance was poor. She stated walking up two flights of stairs caused her to lose her

speech and become presyncopal. She started taking midodrine,71 but it was difficult to know if

she had a significant response. She also took disopyramide72 and gabapentin. She took

Sandostatin which apparently allowed her to eat reasonably. She denied palpitations. She did

not have unusual syncope. She was frequently presyncopal presumably on an orthostatic basis.

She said she had episodic chest pain which totally went away with exercise and she felt best

when exercising vigorously. Id. Dr. Wilkinson’s impression was that petitioner had severe

vasodepressive syndrome, “apparently following viral syndrome,” and “unusual manifestations”

of hypotension which in addition to presyncope included change of voice and dialect. Id. at 2.

On February 15, 2011, petitioner wore a Holter monitor73 for 23 hours and 55 minutes

because of syncope and collapse. Id. at 5. Petitioner reported symptoms of shortness of breath

and chest pain, but the monitor showed they were clearly not related to arrhythmia. Id.

On July 29, 2011, petitioner was evaluated by Dr. Blair Grubb at the Cardiac

Electrophysiology and Autonomic Function Clinic at the University of Toledo Medical Center.

Med. recs. Ex. 38, at 1. Dr. Grubb writes petitioner developed POTS because of flu vaccination.

Dr. Grubb was under the impression that petitioner received flu vaccine on September 3, 2009,

rather than the actual date which was August 23, 2009. Therefore, his statement that “shortly

thereafter” (i.e., shortly after the vaccination), petitioner began to experience muscle weakness,

fatigue, and exercise intolerance as well as POTS is inaccurate. Petitioner continued to

misinform Dr. Grubb because he notes petitioner was diagnosed with GBS as a consequence of

vaccination.74 Id. On physical examination, petitioner’s supine blood pressure was 148/78 and

her upright blood pressure was 148/84. Her pulse in both supine and upright positions was 79.

Id. To Dr. Grubb, “it sounds as though she has developed an autonomic neuropathy” as the

result of a reaction to the vaccination. Id. at 1-2. Dr. Grubb stated that he had “personally seen

this on several occasions previously” and “in most cases of postural tachycardia syndrome in

adults, they were well either until a viral infection or similar immunologic stimulus caused them

to produce autoantibodies against peripheral acetylcholine receptors in the sympathetic and

parasympathetic system.” Id. at 2. Dr. Grubb suggested adding pyridostigmine (Mestinon) to

71

Midodrine hydrochloride is “a direct-acting sympathomimetic agent, which stimulates the ɑ-adrenergic receptors

of the arteriolar and venous vasculature; used as a vasopressor in the treatment of orthostatic hypotension.”

Dorland’s at 1165. A vasopressor stimulates “contraction of the muscular tissue of the capillaries and arteries.” Id.

at 2027.

72

Norpace. See supra, n.58.

73

A Holter monitor is a type of ambulatory EKG. Dorland’s at 1175.

74

Petitioner’s history to Dr. Grubb and his reliance on it are inconsistent with petitioner’s medical records where her

treating doctors ruled out GBS. Med. recs. Ex. 44, at 17.

41

petitioner’s medical treatment of Neurontin, Norpace, midodrine, and octreotide. While noting

Mestinon was initially used to treat myasthenia gravis, its use has extended to autonomic nervous

system disease. For petitioner’s cognitive impairment, he prescribed Cerefolin NAC. He

described it as a modified form of folic acid frequently used to treat cognitive impairment

associated with chemotherapy. Dr. Grubb spent two and one-half hours with petitioner. Id.

On August 12, 2011, petitioner had a single-photon emission computed tomography

(“SPECT”) brain scan at Cedars-Sinai Medical Center that Dr. Kelly E. Williams, petitioner’s

new PCP, requested. Med. recs. Ex. 39, at 2-3; Ex. 52, at 5-6; Ex. 54, at 13. According to the

report, Dr. Alan D. Waxman noted marked reduction in perfusion of the watershed75 areas of the

frontal lobes extending to the posterior brain and a decrease in perfusion in the right thalamus

when compared to the left. Med. recs. Ex. 39, at 2, and Ex. 54, at 13. The periventricular white

matter/ventricular regions were within normal limits. There was a slight but definite decrease in

the right cerebellum when compared to the left. Dr. Waxman’s impression was that the findings

were consistent with a vascular process, mainly impacting the small vessels and, to some extent,

branches of the right middle cerebral artery and left posterior cerebellar artery. Dr. Waxman

stated these findings were highly associated with systemic lupus or other autoimmune processes,

including antiphospholipid antibody syndrome. Id. Lyme disease was a consideration as well.

Med. recs. Ex. 39, at 3.

However, petitioner’s laboratory testing for antiphospholipid antibodies, C-reactive

protein, Cyclic Citrullinated Peptide (“CCP”) antibody, and ANA choice Cascade antibody were

all normal. Med. recs. Ex. 41, at 1-5, and Ex. 42, at 30-37. A handwritten note on the laboratory

test report stated “. . . blood tests all normal. No evidence of autoimmune disease.” Med. recs.

Ex. 42, at 30. The filing of Exhibit 42 lists more blood tests than the filing of Exhibit 41

although they both reflect testing done on August 31, 2011 with reports issued on September 6,

2011. Exhibit 42 includes petitioner’s negative testing for not only phosphatidylserine

antibodies, but also cardiolipin antibodies, IgG, IgM, and IgA. Med. recs. Ex. 42, at 31.

On November 2, 2011, petitioner saw Dr. Elmer Y. Chang, a gastroenterologist, in

Mission Viejo, California, upon Dr. Williams’ referral for an evaluation for postprandial

hypotension. Med. recs. Ex. 114, at 1. In August 2010, petitioner went to UCLA for an upper

endoscopy, CT scan of her abdomen and pelvis, esophageal manometry, and a gastric emptying

study, all of which were reportedly normal. Id. at 2. She was diagnosed with postprandial

hypotension secondary to autonomic dysfunction. Id. She was started on octreotide with

dramatic improvement of her symptoms. Id. at 2-3. Since then, she had not had any further GI

symptoms. Id. at 3. Dr. Chang found petitioner’s vitals and physical examination unremarkable.

His impression was:

This is a very unusual case of postprandial hypotension. Normally,

one would expect [a] slight decrease in systemic blood pressure

following meals due to increased splanchnic blood flow.

75

Watershed is “an area where the peripheries of two vascular beds meet, particularly in the brain.” Dorland’s at

2076.

42

However, because of her autonomic dysreflexia, she develops an

exaggerated blood pressure response. The reason why octreotide

may work for her is that it decreases splanchnic blood flow,

thereby increasing systemic blood pressure. Obviously, large

meals would also increase splanchnic blood flow and should be

avoided.

Id. Dr. Chang recommended petitioner continue with octreotide, which his clinic would

administer to her. In addition, she should eat small meals multiple times a day instead of large

meals so as to decrease the chance of postprandial hypotension. Id.

On December 8, 2011, petitioner saw Dr. Mariko L. Ishimori, a rheumatologist, at

Cedars-Sinai Medical Center, for an assessment of her abnormal SPECT scan and concern for a

possible central nervous system vasculitis. Med. recs. Ex. 54, at 4. Petitioner told Dr. Ishimori

that she had had a severe and unusual reaction to flu vaccination resulting in an autoimmune

reaction two years previously. It started with postprandial hypotension and progressed to

orthostatic hypotension which required hospitalization. Within the first few days of

hospitalization, she developed rhabdomyolysis with CPK peaking at 13,000. She said all these

symptoms progressed and accelerated over one week, escalating over a two-month period during

which she was hospitalized consistently at Inova Fairfax Hospital. Id.

Serologic testing resulted in a negative result for an extensive panel of antiphospholipid

antibodies. Petitioner’s ANA was negative as well. Petitioner stated that she had only one

positive ANA test during her acute hospitalization, and the highest was 1:80. Id. Dr. Ishimori

ordered ANA testing on December 8, 2011. Med. recs. Ex. 57, at 1. Two results are listed:

1:320 (speckled pattern) and 1:40 (homogeneous pattern). Petitioner tested negative for the

following: anti-centromere antibody, anti-SCL-70 antibody, anti-Sm antibody, anti-RNP

antibody, anti-RO antibody, anti-LA antibody, anti-DS DNA antibody, and anti-chromatin

antibody. Anti-DS DNA antibody tested 3.0 when normal is less than 7.0. Petitioner’s

complement C3 tested at 110 when normal is between 79 and 152 mg/dL. Petitioner’s

complement C4 tested at 25 when normal is between 16 and 49 mg/dL. Petitioner tested

negative to cardiolipin, IgG, IgA, and IgM. She tested negative to citrulline, rheumatoid factor,

and thyroid microsomal P antibody. Id.

Petitioner said she tried to exercise 20 hours per week by running, cycling, and

weightlifting. Id. at 5. She did not have a problem with sleep. Petitioner said she had an allergy

to lidocaine,76 Carbocaine,77 Ativan, Zoloft,78 Klonopin, transdermal Scopolamine patch,

Benadryl,79 and NyQuil, all of which resulted in heart palpitations, slurred speech, fainting, and

76

Lidocaine is “a drug having anesthetic, sedative, analgesic, anticonvulsant, and cardiac depressant activities, used

as a local anesthetic.” Dorland’s at 1034.

77

Carbocaine is “trademark for preparations of mepivacaine hydrochloride.” Dorland’s at 288. Mepivacaine

hydrochloride is “a local anesthetic, an analogue of lidocaine.” Id. at 1136.

78

Zoloft is “trademark for preparations of sertraline hydrochloride.” Dorland’s at 2092. Sertraline hydrochloride is

“a selective serotonin reuptake inhibitor, used to treat depressive, obsessive-compulsive, and panic disorders.” Id. at

1699.

79

Benadryl is “trademark for preparations of diphenhydramine hydrochloride.” Dorland’s at 208.

43

difficulty breathing. Id. Dr. Ishimori did a review of systems. Petitioner had fatigue, weakness,

pain, ringing in her ears, and dry mouth. Id. She claimed irregular heart beat and chest pains.

Id. at 6. She had occasional shortness of breath and difficulty breathing at night. She had nausea

and recurrent diarrhea. She had morning sickness lasting one hour, and joint pain involving her

hands and feet. She had headaches, dizziness, fainting, muscle spasm, loss of consciousness,

memory loss, and night sweats, all related to orthostatic hypotension. She had excessive thirst.

Id.

On physical examination, petitioner had a blood pressure of 122/79. She was well-

nourished. She did not have synovitis in the MCP,80 PIP,81 or DIP82 joints. Her hands had full

range of mot

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