Miller v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 11-852V

January 31, 2017

To be Published

***************************************

L.A.M., *

*

Petitioner, * Human papillomavirus (“HPV”) vaccine

* (“Gardasil”); migraines; postural

v. * orthostatic tachycardia syndrome

* (“POTS”); chronic fatigue syndrome;

SECRETARY OF HEALTH * conversion disorder; undifferentiated

AND HUMAN SERVICES, * connective tissue disease (“UCTD”);

* small fiber polyneuropathy.

Respondent. *

***************************************

Patricia A. Finn, Piermont, NY, for petitioner.

Debra A. Filteau Begley, Gordon Shemin, Lara A. Englund, Washington, DC, for respondent.

MILLMAN, Special Master

DECISION 1

On December 6, 2011, when petitioner was still a minor, her father 2 filed a petition pro se

under the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10–34 (2012), alleging

that human papillomavirus vaccine (“Gardasil”) administered on December 3, 2008 caused his

1

Vaccine Rule 18(b) states that special masters shall make all decisions available to the public unless the

decision contains 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. When a special master files a decision, a 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 categories listed above, the special master shall redact such material

from public access. See also 42 U.S.C. § 300aa-12(d)(4)(B)(i) and (ii). Because petitioner requested the

court reporter at trial to redact her name to initials, being under the impression that the transcript would be

publicly available (which is not the case), the undersigned is cognizant that petitioner would want this

decision also to be redacted. Therefore, sua sponte, the undersigned redacts it without petitioner’s

motion.

2

Petitioner’s father is a thoracic and cardiac surgeon at the medical center where petitioner received most

of her medical care.

daughter severe and debilitating headaches, photophobia, 3 phonophobia, 4 extreme fatigue,

dizziness, and gait disturbances. Pet. Preamble & ¶ 2. His daughter having reached the age of

majority, on February 2, 2012, the original petitioner moved to substitute his daughter as

petitioner, which motion the undersigned granted. The current petitioner is the vaccinee.

From December 6, 2011 until June 25, 2012, petitioner’s father (at that time, he was

petitioner) did not file any medical records. On June 25, 2012, petitioner’s father advised the

undersigned during a telephonic status conference he attended with petitioner that petitioner had

retained the services of an attorney, Patricia A. Finn. On July 16, 2012, Ms. Finn moved to

substitute as attorney of record, which the undersigned granted. Ms. Finn said she would obtain

and file the medical records.

On October 19, 2012, petitioner filed a Certificate of Completion, stating that she had

filed a complete set of medical records.

On November 13, 2012, the undersigned issued an Order to Show Cause why the case

should not be dismissed based on the medical records showing that the same symptoms about

which petitioner complained Gardasil caused had occurred prior to vaccination on two occasions,

i.e., in May and June 2007, which her treating doctors attributed to a virus. The undersigned

suggested in the Order to Show Cause that if petitioner wanted to continue her petition, she

should amend her petition to allege significant aggravation. In addition, the undersigned noted in

the Order to Show Cause that the symptoms about which petitioner complained Gardasil caused

had occurred two months after her second Gardasil vaccination in the immediate aftermath of a

sore throat, fever, and swollen glands on February 15, 2009, suggesting that this diagnosed upper

respiratory viral infection triggered the resumption of her pre-vaccination symptoms.

On November 16, 2012, the undersigned held a telephonic status conference with counsel

during which petitioner’s counsel asked for 90 days to find an expert.

On February 25, 2013, the undersigned held another telephonic status conference with

counsel during which petitioner’s counsel said she had contacted Dr. Yehuda Shoenfeld, an

immunologist, who was willing to provide an opinion, which she expected in a month.

Four months later, on June 24, 2013, petitioner filed Dr. Shoenfeld’s response to the

questions the undersigned raised in her November 13, 2012 Order to Show Cause (Exhibit 24)

and also filed Dr. Shoenfeld’s expert report (Exhibit 38). In his response to the Order to Show

Cause, Dr. Shoenfeld attributed petitioner’s condition to aluminum adjuvant in Gardasil vaccine,

basing his analysis on a theory of autoimmune (auto-inflammatory) syndrome induced by

adjuvants (“ASIA”). Ex. 24, at 3 (the pages of the exhibit are unnumbered; the undersigned is

3

Photophobia is “abnormal visual intolerance to light.” Dorland’s Illustrated Medical Dictionary 1441

(32nd ed. 2012) (hereinafter, “Dorland’s”).

4

Phonophobia is “irrational fear of sounds or of speaking aloud.” Dorland’s at 1435.

2

using the CM-ECF numbering). In his expert report, Dr. Shoenfeld discusses the new ASIA

syndrome, which he first described in 2011. Ex. 38, at 2. He also opines that Gardasil caused

petitioner’s postural orthostatic tachycardia syndrome (“POTS”) and chronic fatigue syndrome

(“CFS”). Id. at 6. He notes that POTS and CFS are manifestations of ASIA syndrome. Id. at

10.

On July 19, 2013, respondent filed the expert report of Dr. J. Lindsay Whitton, an

immunologist, disputing the validity of Dr. Shoenfeld’s ASIA hypothesis. Ex. A. On the same

date, respondent filed the expert report of Dr. Edward W. Cetaruk, a toxicologist and specialist in

emergency medicine, also disputing the validity of Dr. Shoenfeld’s ASIA theory. Ex. VV.

On July 26, 2013, Dr. Shoenfeld responded to Dr. Cetaruk’s expert report, defending the

ASIA syndrome. Ex. 137. On August 8, 2013, Dr. Shoenfeld responded to Dr. Whitton’s expert

report, defending the ASIA syndrome. Ex. 249.

On December 6, 2013, respondent filed her Rule 4(c) Report, stating that petitioner did

not have a compensable case.

Together with her Rule 4(c) Report, respondent filed reports from the following three

experts:

(1) Dr. Carlos Rosé, a pediatric rheumatologist (Exhibit RRR);

(2) Dr. Max Wiznitzer, a pediatric neurologist (Exhibit BBBB); and

(3) Dr. Stephen McGeady, a pediatrician and immunologist (Exhibit MMMM).

On March 13, 2014, Dr. Shoenfeld responded to the expert reports of Dr. Rosé, Dr.

McGeady, and Dr. Wiznitzer. Exs. 471, 472, and 473.

On November 18, 2014, petitioner filed the affidavit of her father. Ex. 551. He states

that on or about February 15, 2009, petitioner developed a sore throat, fatigue, low grade

temperature, and swollen glands, which lasted about one week. Id. at ¶ 5. He also states that on

or about February 20, 2009, petitioner began to develop a headache and said it was about a 5 out

of 10 on the pain scale. Id. at ¶ 6. On February 21, 2009, petitioner’s headache worsened and

was about 9 out of 10 on the pain scale. Id. at ¶ 7. She began to experience nausea,

photophobia, and phonophobia, and she had no appetite and refused to eat or drink. She lay on a

couch in a dark, quiet room and did not move. Id. On February 26, 2009, petitioner’s primary

care physician, Dr. Kennette, diagnosed her with migraines and prescribed Lortab and Imitrex.

Id. at ¶ 8. Because the medications did not work, petitioner returned to Dr. Kennette on March 2,

2009. Id. at ¶ 9. Petitioner could not find her balance to walk, although she never had true

vertigo or nystagmus. Id. Petitioner would seem to collapse onto the floor, explaining that her

legs just went weak and she cried all day and night. Id. at ¶ 10. Petitioner was prescribed

Depakene and Antivert, which also did not work. Id. On March 6, 2009, petitioner went to the

Albany Medical Center Emergency Room and received Compazine, Toradol, and Benedryl. Id.

at ¶ 11. Dr. Nichter, a pediatric neurologist, evaluated petitioner and she received Depacon,

3

Reglan, and Compazine. Id. Conversations with Dr. Nichter resulted in an increase in the

dosage of Topamax and the beginning of multivitamins, vitamin B-2, melatonin for sleep, and

Maxalt-MLT. Id. at ¶ 12. He increased her dosage of Topamax three more times. Id. at ¶¶ 12,

14, 17. On April 6, 2009, petitioner saw Dr. Nichter who ordered a steroid pulse and prescribed

Dexamethasone. Id. at ¶ 16. On May 4, 2009, petitioner saw Dr. Magdi Sobeih, a pediatric

neurologist at Boston Children’s Hospital, who found nothing wrong with petitioner. Id. at ¶20.

When Dr. Sobeih suggested petitioner see a psychiatrist or psychologist, petitioner told Dr.

Sobeih her opinion of his diagnosis. Id. On May 21, 2009, petitioner saw Dr. Nichter who

prescribed Elavil and told her to wean off Topamax. Id. at ¶ 23. He increased the dosage of

Elavil three times. Id. at ¶¶ 24, 27, 30. He also prescribed Ativan. Id. at ¶ 30. Hypnosis failed

to resolved petitioner’s headaches. Id. at ¶ 31. On September 8, 2009, Dr. Nichter discontinued

Ativan and started petitioner on Cymbalta. Id. at ¶ 32. On September 16, 2009, petitioner tried

Reglan and Depakote, and a higher dosage of Inderal and Cymbalta. Id. at ¶ 34.

On October 6, 2009, petitioner saw Dr. Nichter because she was having syncopal

episodes: she would see black spots and fall to the floor. Id. at ¶ 35. He noted petitioner had

tachycardia, and weaned her off Inderal. Dr. Nichter said physical therapy was imperative. Id.

On October 21, 2009, petitioner took Ambien for sleep issues. Id. at ¶ 37. On November 6,

2009, petitioner saw Dr. Charles Rheeman, a neuro-ophthalmologist, because she complained of

difficulties with reading. Id. at ¶ 39. Dr. Rheeman examined petitioner and found her normal.

Id. at ¶ 40. Dr. Rheeman thought stressors caused petitioner’s difficulties with reading, which

infuriated petitioner. Id. On December 4, 2009, Dr. Petri suggested petitioner take Plaquenil.

Id. at ¶ 43. On December 17, 2009, petitioner took Midrodine for POTS. Id. at ¶ 44. On

January 14, 2010, petitioner took Florinef. Id. at ¶ 45. On February 11, 2010, petitioner stopped

taking Florinef and started taking Midrodine again, and the doctor increased the dosage March

11, 2010. Id. at ¶¶ 47, 49. On March 1, 2010, Neurontin was increased. Id. at ¶ 48. (The

undersigned counts 23 medications listed in this affidavit, most of them for headache.)

On December 19, 2014, the parties filed a stipulation of interim attorneys’ fees and costs.

The undersigned issued a decision on the same date, awarding interim attorneys’ fees and costs

based on the stipulation.

On May 14, 2015, respondent filed a supplemental expert report of Dr. Rosé. Ex.

AAAAAA.

On June 11, 2015, petitioner filed additional medical records. Exs. 552, 553.

On June 15, 2015, petitioner filed her affidavit. Ex. 554. Petitioner states that on

February 15, 2009, she developed a sore throat, fatigue, a low-grade temperature, and swollen

glands, which continued for about one week. Id. at ¶ 5. On February 20, 2009, she developed a

very painful headache. Id. at ¶ 6. On February 21, 2009, her headache worsened and felt like it

was 9 out of 10 on the pain scale. Id. at 7. She also had nausea, photophobia, and phonophobia.

She had no appetite and refused to eat or drink. She lay on the couch in a dark, quiet room and

4

did not move. Id. Petitioner saw her primary care physician, Dr. Kennette, on February 26,

2009. Id. at ¶ 8. Dr. Kennette diagnosed her with migraines and prescribed Lortabs and Imitrex.

Id. On May 4, 2009, petitioner saw Dr. Magdi Sobeih, a pediatric neurologist, who concluded

there was nothing wrong with petitioner and suggested petitioner see a psychiatrist or

psychologist, which petitioner stated was extremely upsetting to her and traumatized her. Id. at ¶

16. She saw Dr. Steven Sandler, a pediatric psychiatrist, at the end of summer 2009, who told

her he did not suspect her symptoms were psychosomatic, but his attempt to help her headaches

with hypnosis failed. Id. at ¶ 25. Once petitioner started school in September 2009, her

headaches worsened and her improvement in her ability to walk and her gait declined, resulting

in her not attending school. Id. at ¶ 27. On October 6, 2009, petitioner saw Dr. Nichter. At this

point, she was having dizzy episodes where she would see black spots and fall to the floor. Id. at

¶ 29. She also had tachycardia. Id. On October 21, 2009, she saw Dr. Sandler again 5 for

sleeping issues. Id. at ¶ 30. He prescribed Ambien, which resulted in her having severe

disorientation and hallucinations. Dr. Sandler then prescribed Trazadone, but she did not take it

for fear of side effects. Id. On November 6, 2009, she saw Dr. Charles Rheeman, a neuro-

ophthalmologist, for her difficulties in reading but he thought that stress was causing those

problems. She became very upset “because I knew I was suffering from something that was real

and the doctor’s opinion seemed to dismiss everything I had been going through.” Id. at ¶ 33.

On March 1, 2010, petitioner saw Dr. Nichter who questioned the diagnosis of POTS and

petitioner’s being treated with steroids. Id. at ¶ 41. Petitioner states she continues to have

difficulty reading. Id. at ¶¶ 50, 51.

On June 22, 2015, petitioner filed additional medical records. Exs. 573, 574. On that

same date, respondent filed the supplemental expert report of Dr. J. Lindsay Whitton, discussing

and disagreeing with Dr. Shoenfeld’s ASIA theory. Ex. BBBBBB.

On June 24, 2015, petitioner filed additional medical records. Ex. 575.

From July 13-15, 2015, the undersigned held a hearing in this case. Petitioner provided

additional exhibits in this case, which were marked as exhibits 577 and 578 with a color version

of exhibit 576.

On July 21, 2015, respondent filed Ex. AAAAAAA (or for easier reading, Ex. 7A),

consisting of a medical history, dated August 1, 2010, which petitioner’s father prepared and

from which he testified. Petitioner’s father notes that petitioner’s first post-vaccination headache

occurred on February 20, 2009, which was five days after she had a severe sore throat, fatigue, a

low-grade temperature, and swollen glands, but 11 weeks and two days after her second Gardasil

vaccination, administered on December 3, 2008. Ex. 7A, at 1. He dates her inability to walk to

March 2, 2009, or 12 weeks (three months) after her second Gardasil vaccination, describing her

inability as an inability to find balance to walk, although never any true vertigo or nystagmus.

She would just seem to collapse onto the floor. She would describe her legs as just going weak.

5

Petitioner has not filed the medical record reflecting her visit to Dr. Sandler for sleeping issues.

5

Her pain was now 10++ and she was crying throughout the day and night. Id. He notes that on

May 28, 2009, petitioner had increased lower extremity weakness and her headaches were still

problematic. Dr. Nichter described her gait as abasia/astasia. Id. at 2. Petitioner began physical

therapy with Adrian Fil on July 14, 2009. Id. at 3. Petitioner had brain MRIs on March 18, 2009

and June 9, 2009. Both were normal. Id. at 2, 3. She had an EMG nerve conduction study on

July 20, 2009, the results of which were normal. Id. at 3. Petitioner’s father notes that school

began on September 10, 2009. Petitioner tried to make it at school with assistance, but the

crowds, noise, and light became too much. Her headaches worsened even though she had

improved over the summer in her walking and gait. Id. Petitioner’s father notes that petitioner’s

passing out episodes became problematic. She said she saw black spots and then fell to the floor.

She had tachycardia. Physical therapy was deemed imperative. Id. Petitioner’s father notes that

petitioner saw Dr. Sandler for help with sleep problems, and he prescribed Ambien. Petitioner

had severe disorientation and hallucinations that night, including seeing the death of her brother.

Dr. Sandler then recommended Trazadone, but petitioner was reluctant to take it because of her

experience with Ambien. Id. at 4.

Petitioner’s father notes that petitioner saw Dr. Charles Rheeman a neuro-

ophthalmologist because of her difficulty reading. Petitioner’s father notes that the office was

tiny with people and staff everywhere. Dr. Rheeman found petitioner normal after examination

and suggested that stressors were the root of her problem. Petitioner’s father writes that

petitioner promptly told Dr. Rheeman off. Id. Petitioner’s father notes that, from late March to

late April 2010, petitioner had a period of gradual good improvement. Id. at 5. Her headaches

were 3/10. Her school time increased to several hours each morning. She began to play the flute

again. She had been released from physical therapy, but stamina and fatigue were still

problematic. She enjoyed herself on a cruise during Easter break, but had times of needing to

crash. Id. Petitioner’s father notes that, beginning in late April 2010 through May, she had

severe worsening with headaches of “40”/10, according to petitioner. Id. On May 5 and 6, 2010,

petitioner’s father e-mailed petitioner’s story to Dr. Julian Stewart, a pediatric

electrophysiologist at Westchester Medical Center. He replied that petitioner’s blood pressure

that low while supine was not part of POTS at all. He said that even hypotension while upright

is not part of POTs, although late during a tilt-table test, there are gradual vasodepressor

responses. Dr. Stewart inquired whether petitioner had been checked for Addison’s and for any

other symptoms of autonomic failure. Id. (Dr. Stewart’s e-mail response is not part of the

record.) Petitioner’s father notes that, on July 29, 2010, after a consultation with Dr. Jill

Abelseth, an endocrinologist, a Cortrosyn 6 stimulation test for adrenocorticotropic hormone

(“ACTH”) was done, and the result was normal. Id. at 6. Petitioner’s father notes that petitioner

saw Dr. Peter Rowe, a pediatrician, at Johns Hopkins, who felt petitioner had chronic fatigue

6

Cortrosyn is “trademark for a preparation of cosyntropin.” Dorland’s at 422. Cosyntropin is “a

synthetic polypeptide identical with the first 24 amino acids of corticotropin, having the corticotropic

activity of corticotropin but lacking its allergenicity; used in the diagnosis of adrenal insufficiency by

plasma corticol response following subcutaneous, intramuscular, or intravenous injection.” Dorland’s at

424.

6

syndrome. Id. Petitioner’s father notes that from September 2010 to June 2011, petitioner was

back to school full time and missed only two weeks in total. He states she easily fatigued and

always had a headache. Her school absences were related to fatigue or headache worsening. Id.

Petitioner’s father’s chronology ends after June 2011.

On October 28, 2015, petitioner filed her posthearing brief.

On February 1 29, 2016, respondent filed her posthearing brief.

FACTS

Pre-vaccination Records

Petitioner was born on February 2, 1994.

On April 5, 2004, petitioner went to her pediatrician, Dr. Karen M. Kennette at Pondview

Pediatrics, complaining of having a cold for two and one-half weeks. Med. recs. Ex. 575, at 1.

She still had a low-grade fever and was sleeping nonstop. Her father was worried because she

had been sleeping a lot since she had a strep throat possibly in December. Id. On physical

examination, petitioner’s tympanic membranes were congested, her nose had copious drainage,

and her throat was beefy red with a thick post-nasal drip. Her nasal mucosa were inflamed with

the left nostril completely occluded. Id. A quick strep test was negative. Dr. Kennette

diagnosed petitioner with pharyngitis/sinusitis and prescribed Flonase, albuterol inhaler, and

Zithromax. Id.

Also on April 5, 2004, petitioner’s Epstein-Barr virus (“EBV”) nuclear antigen 7 was

weakly positive at 1:10. Med. recs. Ex. 8, at 16.

On March 14, 2005, petitioner saw Dr. Richard L. Uhl, an orthopedist, for a fracture to

her left ring finger. Med. recs. Ex. 14, at 1.

On April 4, 2005, petitioner returned to Dr. Uhl, complaining her ring finger was still

tender and painful. Id. at 2.

On April 29, 2005, petitioner returned to Dr. Uhl. Her finger fracture completely healed.

Id. at 3.

On October 24, 2005, petitioner went to Dr. Uhl with a right heel injury. The x-rays did

not show any abnormalities. Id. at 4.

7

Nuclear antigens are “the components of cell nuclei with which antinuclear antibodies [ANA] . . . react.”

Dorland’s at 105. “Antinuclear” is destructive to or reactive with components of the cell nucleus, as

antinuclear antibody.” Id. at 108.

7

On April 6, 2006, petitioner went to Dr. Uhl, complaining of a right ankle injury, which

he diagnosed as a fracture. He recommended a short leg cast. Id. at 5.

On April 17, 2006, Dr. Uhl switched petitioner into an equalizer boot. The x-rays

showed no displacement. Id. at 6.

On April 25, 2006, petitioner saw Dr. Uhl on an urgent basis because of a new injury to

her right lower extremity. Id. at 7. She gave a history that her leg fell through a beach chair and

she hit her ankle. She had increased pain in her foot, ankle, and knee. She said her knee was

bruised. Dr. Uhl evaluated petitioner’s knee and found it was not particularly bruised or tender.

The ankle was slightly tender. X-rays showed absolutely no displacement from the initial films.

Dr. Uhl suspected this was a contusion. Id.

On May 6, 2006, petitioner saw Dr. Uhl, complaining of pain in her foot, which was

slowly improving. Id. at 8.

On June 26, 2006, petitioner saw Dr. John A. DiPreta, another orthopedist with the same

group as Dr. Uhl. Id. at 9. He said petitioner had a history of recurrent ankle injuries. Petitioner

and her mother felt she had not really gotten any better and the ankle was not quite right. She

had pain in various parts of her ankle since her injury. Petitioner had another injury on June 25,

2006 after getting out of the pool when her ankle gave out. She had sharp, shooting pains.

Petitioner and her mother were quite frustrated because they felt this interfered with petitioner’s

ability to participate in activities. On physical examination, her sensory exam was normal. The

range of motion of her ankle, hindfoot, and midfoot were within normal limits. Strength

measured 4+/5. X-rays were unremarkable. Dr. DiPreta’s impression was petitioner had right

ankle pain. He questioned whether petitioner had some sort of deconditioning and would benefit

from physical therapy. Id.

On March 30, 2007, petitioner saw Dr. Uhl for pain to the end of her right thumb. Id. at

10. X-rays were negative for fracture and the thumb did not droop. Id.

On June 6, 2007, when petitioner was 13 years old, she went to Pond View Pediatrics,

complaining that, for the prior six days, she had had severe headaches, great sensitivity to light,

and dizziness. Med. recs. Ex. 12, at 16 (same record at Ex. 574, at 3). She said she felt as if she

were on a boat. Id. She was afebrile and did not have cold symptoms. Id. When she stood up,

she felt very dizzy. Id. Dr. Kennette examined petitioner in a dark room where petitioner was

wearing dark sunglasses. Id. Petitioner’s gait was slightly slow secondary to her headaches. Id.

The doctor’s differential diagnosis was migraine, 8 Lyme disease, and viral meningitis. Id.

8

Migraine is “an often familial symptom complex of periodic attacks of vascular headache, usually

temporal and unilateral in onset, commonly associated with irritability, nausea, vomiting, constipation or

diarrhea, and often photophobia. Attacks are preceded by constriction of the cranial arteries, often with

8

On June 7, 2007, petitioner’s father called Dr. Kennette to say that petitioner still had a

severe headache. Med. rec. Ex. 12, at 17 (same record at Ex. 574, at 6). On June 7, 2007,

because of petitioner’s headaches, she underwent a brain MRI. Med. recs. Ex. 552, at 46 (same

record at Ex. 574, at 1). It was normal. Id.

On June 8, 2007, petitioner’s mother called the pediatrician to say that petitioner was still

complaining of a headache. Med. recs. Ex. 12, at 18. It was absolutely no better. Petitioner was

taking her medicines and resting. She had to lie in a dark room. The mother said petitioner’s

brain MRI was negative and she wanted to know what else could be done. Petitioner’s mother

was very upset. Id. The pediatrician’s staff telephoned petitioner’s mother to take petitioner to

Albany Medical Center emergency room since her pain was no better. Id. Petitioner could get a

neurologist to check her there and obtain IVIG medications. Id.

On June 8, 2007, petitioner went to Albany Medical Center Emergency Department at the

suggestion of her pediatrician. Med. recs. Ex. 1, at 1. Dr. Noah White examined her and took a

history that she had an episode three weeks earlier while refereeing a children’s soccer match in

which she felt as if her head were spinning, and she had some headache associated with that

feeling. Id. She had had to sit down. Id. This episode resolved within 24 hours. Id. Petitioner

said she had been fine until about one week previously when she again developed a headache

similar to the previous headache. Id. It was bilateral and frontal. Id. She had only a mild

amount of dizziness. Id. She also had photophobia, phonophobia, and associated nausea. Id.

She saw her primary care physician, who recommended she have a neurology consult. Id. She

had some associated nausea, but no vomiting. Id. In addition, petitioner had been at the

Emergency Department on June 7, 2007 for the same problem, during which she participated in

tests, including a brain MRI. The test results were normal, except for a complete blood count,

which had an elevated white count of 10,600. Id. On physical examination, petitioner was

sitting in a darkened room and appeared to have a mild amount of discomfort. Id. Dr. White

diagnosed petitioner with migrainous headache, prescribed Compazine, and recommended she

have a neurologic consultation. Id. at 2. The neurologist on call was Dr. Jerome Haller, a

pediatric neurologist, who saw petitioner and agreed she had migrainous-type headache. Id. Dr.

Haller believed her history suggested she had a basilar migraine three weeks earlier, and

prescribed Imitrex with a follow up with a neurologist in six to eight weeks. Id. After the

administration of Compazine and Benadryl, petitioner said her headache had significantly

improved to a 2/10 from a prior 6/10. Id. The final diagnosis was migraine. Id. Dr. White also

discussed the case with Dr. Chame Blackburn, an emergency medicine physician. Id. at 2, 3.

On June 20, 2007, petitioner saw Dr. Uhl, complaining of reinjuring her right ankle.

Med. recs. Ex. 14, at 11. X-rays were normal. Id.

resultant prodromal sensory (especially ocular) symptoms . . .; the migraines themselves commence with

the vasodilation that follows. Two primary types are distinguished [migraines with aura and migraines

without aura]; the variety without an aura is more common.” Dorland’s at 1166.

9

On August 14, 2007, petitioner complained to her pediatrician of being tired when she

was walking while on a trip with her family. It was unclear what was the etiology for her fatigue

when she was walking. Dr. Kennette told her to keep a log. Med. recs. Ex. 12, at 11 (same

record at Ex. 574, at 2.)

On December 10, 2007, petitioner saw Dr. Uhl, complaining of injuring her right ankle

again. Med. recs. Ex. 14, at 12. Dr. Uhl suspected a ligament sprain. Id.

On January 9, 2008, petitioner saw Dr. Uhl, who noted she was improving following her

sixth ankle sprain. Id. at 13. She needed to go to physical therapy. Id.

On March 14, 2008, petitioner saw Dr. Uhl with an injured left thumb. Id. at 14. This

appeared to be a sesamoid fracture. Id.

On March 25, 2008, petitioner returned to Dr. Uhl, complaining that the cast was

bothering her and that she had pain in her thumb. Id. at 15. Dr. Uhl removed the cast. New x-

rays showed the alignment maintained. All splints tried on petitioner were uncomfortable. They

settled on a particular splint. Id.

On March 26, 2008, petitioner’s mother called Dr. Uhl and said petitioner’s thumb was

discolored and quite cool. Id. at 16. They came in and Dr. Uhl removed the splint. He made a

new splint molded around the thumb, which she seemed to tolerate much better. He discussed

the possibility of a regional pain syndrome. Id.

On April 2, 2008, petitioner returned to Dr. Uhl with her left thumb looking better. Id. at

17. However, petitioner complained that her pain persisted and she held her hand in a flexed

position. Dr. Uhl recommended petitioner start Neurontin 100 mg. in the evening for nerve-

related pain. Id. Petitioner complained of numbness and tingling throughout the thumb. Id.

On April 14, 2008, petitioner returned to Dr. Uhl saying she was no better, but her thumb

in fact looked better. Id. at 18. Her hand was moving better. Dr. Uhl wanted to increase her

Neurontin to twice a day. Id.

On May 5, 2008, petitioner returned to Dr. Uhl, looking somewhat better. Id. at 19.

On June 9, 2008, petitioner returned to Dr. Uhl, having made minimal progress. Id. at 20.

She was unable to move her thumb particularly well. She had spasms when attempting to do so.

Her hand was not particularly swollen. Dr. Uhl suspected petitioner had a complex regional pain

syndrome in addition to her microtrabecular fractures. Id.

10

On June 30, 2008, petitioner returned to Dr. Uhl, having reinjured her left thumb. Id. at

22. X-rays were negative. Id. He thought she should look for other causes of her discomfort.

Id.

Post-vaccination Records

On August 26, 2008, petitioner received her first Gardasil vaccination. Med. recs. Ex.

13, at 3.

On September 2, 2008, petitioner returned to Dr. Uhl with an injury to her left ankle.

Med. recs. Ex. 14, at 23. X-rays showed a non-displaced fracture. Her left thumb was doing

much better. Id.

On September 8, 2008, petitioner saw Dr. Uhl for a left distal fibula fracture. Id. at 25.

She was having problems with the cast rubbing her big toe. Dr. Uhl did not even see a fracture

on x-ray. But he thought she did have one. Id.

On September 22, 2008, petitioner returned to Dr. Uhl. Her left ankle fracture was

healing slowly. Id. at 24.

On October 8, 2008, petitioner saw Dr. Uhl, having reinjured her left ankle. Id. at 26. X-

rays did not show any specific abnormalities. Id.

On December 3, 2008, petitioner received her second Gardasil vaccination. Med. recs.

Ex. 13, at 3.

On February 26, 2009, two and three-quarters months after vaccination, petitioner went

to Pond View Pediatrics to see her pediatrician Dr. Kennette, complaining of a bad headache she

had since February 21, 2009, of feeling not good, and having weak pain, cold symptoms, nausea,

fever, dizziness, and photophobia. Med. recs. Ex. 12, at 26. That morning, she took two Advil

and drank ginger ale without any change in her headache. Id. She had been on Cipro 9 since the

prior Thursday. Id. Her father, a physician, wrote the prescription for Cipro for presumed

sinusitis. Id. The pediatrician diagnosed petitioner with photophobia, bitemporal squeezing

9

Cipro is the trademark name “for preparations of ciprofloxacin hydrochloride.” Dorland’s at 362.

Ciprofloxacin is “a fluoroquinolone antibacterial effective against many gram-positive and gram-negative

bacteria. . . .” Id. Some of the possible side effects of Cipro are: headache with chest pain and severe

dizziness; fainting; fast or pounding heartbeats; muscle pain or weakness; being more sensitive to

temperature, light touch, or the sense of body position; changes in mood or behavior, including

depression, confusion, hallucinations, paranoia, tremors, feeling restless or anxious, unusual thoughts or

behavior, insomnia, and nightmares; increased pressure inside the skull, including severe headaches,

ringing in the ears, vision problems, and pain behind the eyes; severe skin reaction, including a red or

purple skin rash that spreads; and nausea, vomiting, and diarrhea.

https://www.drugs.com/ciprofloxacin.html (last visited: January 7, 2017).

11

pain, and migraine. Id. Petitioner walked out of the doctor’s office holding onto her mother’s

arm. Id. The physician presumed petitioner had sinusitis. Id.

On March 1, 2009, at 8:30 p.m., the pediatrician’s office notes a telephone call regarding

petitioner. Id. at 27. Petitioner had had a headache for one week and saw Dr. Kennette, who

gave her Lortab and Imitrex and petitioner got some relief, but she was crying in pain and

nauseated. Id. She did not vomit, but had photophobia. Id. Petitioner was advised to try two

tablets of Lortab and see if they helped. Id. If petitioner did not have relief, she was told to go to

the emergency room. Id.

On March 2, 2009, at 10:40 a.m., the pediatrician’s office notes a telephone call

regarding petitioner. Id. Petitioner did not go to the emergency room. She took the Lortab and

in six to seven hours after she used ice, she seemed a little better. Id. Petitioner just woke up

about 20 minutes earlier. She still had a headache but it was not as bad. She had no other

symptoms and was not ill. Id. Petitioner could move her head and neck fine. Her mother would

watch her that day. If she got worse, she was to call back for an appointment that day. If she

woke on the following morning and still had a headache, she should call for an appointment that

day. Id.

On March 3, 2009, petitioner’s EBV nuclear antigen was weakly positive at 1:10. 10 Med.

recs. Ex. 8, at 16.

On March 6, 2009, petitioner went to the Albany Medical Center Emergency Department

where she saw Dr. Joshua J. Hurwitz, who admitted her as an in-patient. Med. recs. Ex. 1, at 4.

Petitioner said she had two and one-half weeks of migraine headache pain (putting onset in the

third week of February 2009, or two and three-quarters months after the second Gardasil

vaccination.) Id. She complained of alternating symptoms of pressure, stabbing, multilocational

pain, bitemporal pressure, vertigo, nausea and vomiting with low-grade fever. Id. She stated she

had had one previous episode like this in July 2008 (one month before her first Gardasil

vaccination) when she had a couple of weeks of headache pain, which the doctors diagnosed as

migraine after a normal brain MRI. Id. One new symptom was retro-orbital pressure and ataxia.

Id. She felt as if the room were spinning. Id. Her pediatrician was Dr. Karen Kennette. Id.

Over the prior couple of weeks, she had tried Percocet, Imitrex, NSAIDs, Benadryl, Compazine,

Depakene, and Antivert. Id. None of these medications addressed her pain. Id. On physical

examination, petitioner had a negative Romberg sign 11 yet she appeared to overcorrect with loss

of balance. Id. at 5. Her gait was narrow-based, but ataxic with petitioner requiring assistance in

order to ambulate without falling. Id.

10

This was the same result as on April 5, 2004 (pre-vaccination). Med. recs. Ex. 8, at 16.

11

The Romberg sign is “swaying of the body or falling when standing with the feet close together and the

eyes closed; the result of loss of joint position sense, seen in tabes dorsalis and other diseases affecting the

posterior columns.” Dorland’s at 1715.

12

On March 6, 2009, on recommendation from Dr. Hurwitz, petitioner saw Dr. Charles

Nichter, a pediatric neurologist. Id. at 7. He took a history from petitioner and her parents. Id.

Unlike the history petitioner gave Dr. Hurwitz in the Emergency Department, petitioner told Dr.

Nichter that there was no clear nausea or vomiting with her headaches. Id. She also told him

that, two years previously (2007), she had a similar event, which was brief. Id. Petitioner’s

family history was positive for multiple sclerosis. Id. On physical examination, petitioner had a

normal gait. Id. at 8. She did tandem gait with “an ever so slight wobble.” Id. She hopped on

one foot and two feet. Id. She squatted without difficulty. Id. Dr. Nichter assessed petitioner as

having headaches and dizziness. Id. He felt she did not have concerning ataxia or vertigo. Id.

She also did not have nystagmus. Id. He felt her variety of medications might have been

exacerbating her headaches. Id. Dr. Nichter prescribed Reglan and then Depacon. Id. In future,

he would decide whether to prescribe Depakote or Topamax. Id.

On March 8, 2009, petitioner’s father telephoned the staff physician to report that

petitioner had a good day March 7, 2009, but on March 8, 2009, she had a headache of 9/10 and

difficulty sleeping the prior night. Id. at 11. She could walk with a little assistance. Id.

On March 13, 2009, Dr. Kennette wrote a letter to petitioner’s high school, explaining

that petitioner had been unable to attend school for the prior two to three weeks due to severe

daily headaches. Petitioner had been unable to sit, stand, or concentrate long enough to attend

classes. Id. at 33.

On March 16, 2009, petitioner’s mother telephoned Dr. Nichter to say that petitioner was

a little better, had less headache, and functioned better. Med. recs. Ex. 1, at 12. Petitioner went

walking for half a block the day before. Id. She had some dizziness and a sense of spinning. Id.

She was able to get out of bed and went to school for half a day the prior week. Id. Dr. Nichter

advised increasing petitioner’s vitamin B2 and continuing on multivitamins with B complexes

and magnesium. Id. She was to continue on Topamax. Id.

On March 18, 2009, petitioner underwent a brain MRI because of her migraine

headaches. Med. recs. Ex. 552, at 45. The MRI was normal. Id.

On March 26, 2009, Dr. Nichter saw petitioner with her parents as a follow up visit to his

initial visit with her in the Emergency Room on March 6, 2009 for migraines. Med. recs. Ex.

553, at 115. Petitioner gave Dr. Nichter a history that she had a sore throat after receiving

Gardasil vaccine, and then, a week or two afterwards, had significant migraine headaches. Id. at

116. Since the emergency room visit, petitioner’s mother states petitioner was better. Id. Her

headaches started at 2-3/10 in the morning. Id. By the afternoon, they might increase to 4-5/10,

and by evening, 8/10. Id. She did not have stabbing, sharp pains. Id. The headaches were more

throbbing and pressure-like. Id. She had significant photophobia and significant vertigo. Id.

Overall she was minimally to mildly better. Id. Petitioner’s headaches, vertigo, and photophobia

made her dysfunctional even when she wore sunglasses. Id. Petitioner did not have frank

weakness, but rather just unsteadiness. She did not have marked lethargy or unresponsiveness.

13

She did not have any activity to suggest seizures. There was a family history of multiple

sclerosis, but no headaches. Her brain MRI, MRA, and MRV were unremarkable. Id. On

physical examination, she had no focal weakness. She could hop on one foot and two feet, but

required support from a table or a chair. Id. at 117. She could walk 10 feet, but often sought her

mother’s support. Id. Dr. Nichter’s assessment was that her significant migraine might relate to

Gardasil, “although there is no clear literature to support that.” Id. His plan was to increase

petitioner’s vitamin B2 and her Topamax dosage. Id. He considered steroids (Decadron or

prednisone) in the future. Id.

On March 31, 2009, Dr. Kennette’s office received a telephone call from petitioner’s

mother. Med. recs. Ex. 12, at 35. Petitioner’s mother wanted the lot number of the Gardasil that

petitioner had received. She said that petitioner’s headaches had been ongoing since petitioner

received Gardasil. In addition, a friend had received the same lot number of Gardasil and she

had the same problem as petitioner. Id.

Also on March 31, 2009, Dr. Kennette filled out a VAERS (Vaccine Adverse Event

Reporting System) form, writing that petitioner received Gardasil on December 3, 2008 and the

onset of her vaccine reaction on February 21, 2009 or eleven weeks and three days later. Med.

recs. Ex. 12, at 34. The only adverse event Dr. Kennette described was protracted headache. Id.

Dr. Kennette states on the VAERS form that petitioner recovered. Id.

On April 6, 2009, petitioner and her parents saw Dr. Nichter again. Med. recs. Ex. 1, at

16. She had slight improvement, but on Thursday night and Friday, she was working on a school

project and sleep was difficult. Id. On Friday, her headaches were 9/10 to 10/10, bitemporal,

and crushing, associated with photophobia, and phonophobia. Id. She did not vomit, but her

appetite had significantly decreased, and she had lost four pounds. Id. She swayed from side to

side and, sometimes, her legs felt like jello with her knees about to give out. Id. Sometimes, the

fragrance of foods nauseated her. Id. On physical examination, petitioner could sit but tended to

lean. Id. at 17. When she walked, she leaned along furniture without frank ataxia, but with a

leaning on objects kind of gait. Id. She could not stand independently. Id. Dr. Nichter assessed

petitioner as having minimally improved migraine, and a wobbly gait although not formally

vertigo (she said nothing was spinning or tilting), and no clear ataxia. Id.

Also on April 6, 2009, petitioner’s ANA was 1:640 with an atypical discrete speckled

pattern. Med. recs. Ex. 1, at 19.

On April 13, 2009, petitioner and her parents saw Dr. Nichter again. Med. recs. Ex. 1, at

19. She had significant photophobia, but her blurred vision resolved. Id. She had a slight

improvement in appetite. Id. Besides her headaches, her gait was of concern. Id. Her legs

seemed to her as if they were going to give in. Id. At times, she had more of a slither to the

ground than a frank direct fall from a standing position. Id. She had a little left neck tenderness

that appeared mild. Id. After a physical examination, Dr. Nichter wrote her migraines had

14

improved, petitioner had minimal to no vertigo and minimal to no ataxia. Id. at 20. She had a

wobbly gait, without evidence of posterior column dysfunction. Id.

On April 22, 2009, Dr. Kennette’s office called petitioner’s mother. Med. recs. Ex. 12, at

37. Petitioner still had daily headaches, which were worse at night, and felt that her legs were

not part of her body. She was unable to walk without holding onto objects. She had been unable

to attend school for the past month. There was a lot of stress at home since petitioner’s maternal

grandmother died on March 22, 2009 and petitioner’s father had surgery during the past month.

Id. Petitioner’s father was meeting with Dr. Sarah Elmendorf and would like Dr. Kennette to

call him. Id. Dr. Kennette’s office notes on April 23, 2009 that there were telephone calls over

the prior 24 hours with petitioner’s mother, father, and Dr. Elmendorf. Id. at 39. Petitioner was

not improving at all. She had headaches, weakness, poor appetite, and had lost some weight. Id.

On April 23, 2009, petitioner’s mother phoned Dr. Kennette’s office. Id. at 38. She

wanted the vaccination dates and lot numbers for the Gardasil petitioner received and the name

of who administered the vaccination. This information had been previously sent to petitioner’s

mother, but she misplaced it and needed it immediately because she, her husband, and petitioner

were going to Boston and putting together a log of events. In addition, she wanted the dates of

petitioner’s visits for headaches. Dr. Kennette’s assistant started with June 2007. Id.

On April 24, 2009, petitioner’s father called, concerned that petitioner now complained

of muscle pains and had Theraband for home exercises. Id. at 40. There was a question whether

her symptoms represented a myositis syndrome or if she had conversion syndrome because of

astasia-abasia. Id.

On April 28, 2009, petitioner’s mother called Dr. Kennette’s office. Id. at 41. Petitioner

was getting worse. Dr. Kennette was supposed to be setting up a visit to a doctor in Boston.

Petitioner’s father wanted to speak to Dr. Kennette. Id.

On May 1, 2009, petitioner visited Dr. Kennette for a reevaluation of her “weakness”

(which Dr. Kennette put in quotation marks) and headaches. Id. at 42. Petitioner had not been in

school for two months and was unable to walk or stand from a sitting position without assistance.

Her feet felt cold and she weighed 116.5 that day. Petitioner walked down the hall hugging the

wall. She sat in a dark room with sunglasses on. When she sat on the examination table, she

leaned against the wall. Her muscle tone had decreased. The strength in her lower extremities

seemed to be 4+ to 5 out of a maximum of 5. Her deep tendon reflexes in her lower extremities

were difficult to elicit. Petitioner’s mood was depressed but her orientation normal. She felt

tired, sad, and frustrated. She had normal skin temperature and color over her feet and hands.

She was wearing a T-shirt, sweatshirt, and heavy sweat pants. The outside temperature was

about 65 degrees. Petitioner had protracted inability to walk without support, a persistent

“migraine”-like headache (Dr. Kennette put “migraine” in quotation marks), mild anorexia, an

eight-pound weight loss over 8-10 months, and mild depression. She questioned whether

petitioner had an undiagnosed neuromuscular condition. Id.

15

On May 4, 2009, petitioner saw Dr. Magdi Sobeih, a behavioral neurologist, at Children’s

Hospital in Boston. Med. recs. Ex. 2, at 1. Dr. Sobeih saw petitioner to evaluate her headache

and walking difficulties. “After a thorough evaluation I have concluded that there are no

neurobiological abnormalities or neuropathological concerns to [petitioner]’s complaints.” Id.

Dr. Sobeith recommended petitioner participate in therapy and take Elavil. He did not

recommend that she have any further neurological workup but follow up with her primary

physician. The history petitioner’s parents gave was that during February break, petitioner

complained of a sore throat and was ill for one week. On Monday, she went to school but the

school sent her home because she was feeling ill. On Tuesday, she went back to school and

complained of headaches with a stabbing type of pain all around, more on the right side. She

described it as vise-like, which then progressed to a pressure-like headache. She stated it felt as

if someone were dropping an anvil on it. She described pressure all around her head. None of

the therapeutic interventions made any difference. Loud noise or attempts to read made her

headaches worse. Her appetite decreased and she lost ten pounds. Certain smells bothered her.

She complained of dizziness. She felt unsteady and needed to lean on a wall. This resulted in

her inability to ambulate effectively. She tended to slide along a wall. “There has been some

suggestion of temporal association according to the family with [petitioner] having received the

HPV vaccine and then subsequently had the sore throat and a week later having headaches.” Id.

Because of her headaches, her doctor started her on Topamax, vitamin B2, magnesium, a

multivitamin, and Ibuprofen. None made any difference to her headache in any way. Id. at 2.

The most recent symptoms had been difficulty in ambulation. She felt as if she were swaying

from side to side and her legs and knees were going to give out. She had to lean on a wall in

order to get up or to walk. She also wore dark glasses because light bothered her eyes. She was

unable to attend school for many weeks and had a home tutor. All of petitioner’s lab work was

negative. She had negative Lyme titers, negative Epstein-Barr virus titers, and a normal C-

reactive protein of 0.2. Dr. Sobeih believed petitioner’s antinuclear antibody of 1:640 with an

atypical discrete speckled pattern was probably a false positive. Her sedimentation rate was

eight, which is normal. Id. Her DNA antibody was negative for double-stranded DNA. Id. at 2-

3. Her brain MRI, MRA, and MRV were normal. Id. at 3. On physical examination, petitioner

could not bear weight on her legs and walk. She complained of photophobia and covered her

eyes. On gait testing, petitioner had a significant amount of astasia-abasia. 12 She had a

12

Abasia-astasia or 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. Hysterical ataxia is “ataxia that is part of a conversion disorder.” Id. at 171. Ataxia is

“failure of muscular coordination; irregularity of muscular action.” Id. at 170. 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 gain) provided by the symptoms, or (3) secondary gains (support, attention, avoidance of

unpleasant responsibilities) provided by the symptoms. . . . [H]istrionic personality traits are also

common. Symptoms are neither intentionally produced nor feigned. . . .” Id. at 549. “Histrionic” is

16

completely functional 13 gait without weakness. Sensory examination and coordination were

normal. She did not have dysmetria or ataxia. Dr. Sobeih wrote:

I had a long discussion with the parents that there is no

neuropathological finding. There is no focality on neurological

exam; there is no neurological cause for [petitioner]’s symptoms.

This did present as a functional gait disturbance.

Id. Dr. Sobeih recommended that petitioner have ongoing counseling. He stated, “I do not feel

there is any association between the Gardasil HPV vaccine and the onset of these symptoms.”

Id. He continued:

I discussed this at length with the parents. I discussed that this is

presenting as a mood disorder that needs appropriate care. . . . It

would be very important to[o] that [petitioner] continue under the

care of appropriate psychological or psychiatric services and

someone to monitor her response to any medications such as

amitriptyline. However I do not feel there is any need for any

further neurological workup or followup. I discussed this with the

parents and with [petitioner] and I counseled further mental health

care should be provided.

Id. at 3-4.

On May 5, 2009, petitioner’s mother called Dr. Kennette. Med. recs. Ex. 12, at 44. The

consultant in Boston felt petitioner had nothing neurologically wrong with her, that she never

had migraines, and was depressed. Id.

Also on May 5, 2009, Dr. Kennette filled out a child and adolescent psychiatric telephone

consultation request to Four Winds Foundation, asking if a psychiatrist would see petitioner for

conversion syndrome. Id. at 48. Petitioner had been seen in Boston where she received an

assessment of “no neurological disease” and a question arose concerning whether petitioner were

depressed and should have a trial antidepressant and therapeutic counseling. Id. The

recommendation was to have petitioner’s parents call for an appointment.

“excessively dramatic or emotional; of or relating to the behavioral characteristics of histrionic

personality disorder.” Id. at 864. Histrionic personality disorder is “a personality disorder marked by

excessive emotionality and attention-seeking behavior.” Id. at 550.

13

A functional disorder is “a disorder of physiological function having no known organic basis. . . . [T]he

term is often used in psychiatry as roughly equivalent to ‘psychogenic disorder’ . . . .” Dorland’s at 550.

17

On May 6, 2009, petitioner’s mother called Dr. Kennette. Id. at 45. Petitioner was going

back to school. The school needed a note stating she could return and limit herself to part-time

attendance. Petitioner would be in a wheelchair. Id.

On May 7, 2009, Dr. Kennette called petitioner’s father to discuss where to go from

there. Id.

On May 8, 2009, a nurse’s note from Dr. Kennette’s office states that petitioner was

concerned because Boston doctors suggested a psychiatrist assess her. Id. at 47. Petitioner

requested a meeting with Dr. Kennette to discuss this. In addition, when petitioner’s mother

brought the doctor’s note to school, indicating petitioner would be coming back to school part-

time, the mother ran into petitioner’s former coach and gym teachers. While discussing

petitioner, the coaches indicated that a lot of girl athletes seemed to be “sick” (the nurse used

quotation marks around “sick”) now and were unable to do sports. Petitioner’s mother was

obtaining a list of the girls’ names from the teachers and coaches and was having the parents call

her to see if these girls’ sicknesses were associated with Gardasil. Id.

On May 8, 2009, Dr. Kennette met first with petitioner’s parents and spoke to them for

20 minutes. Id. at 46. Then, Dr. Kennette met with petitioner and spoke to her for about an hour

alone. They discussed how petitioner felt, what had and had not helped, the need for her to go

back to school, strategies for coping with food, sound and light sensitivity, dealing with parental

and friends’ expectations, etc. Dr. Kennette emphasized that petitioner needed to go back to

school, with or without a wheelchair, on a full-time basis. She needed to work with the gym and

music teachers for alternative work, e.g., physical therapy sessions instead of gym, composition

instead of playing in music class. Petitioner needed to check with her neurologist regarding her

use of Topamax since it was not helping. Perhaps she should start a new medicine such as Elavil

for headache and mood. She needed a positive outlook on improvement. Id.

On May 12, 2009, petitioner saw Dr. Jason Mouzakes, an ear, nose, and throat specialist,

for a vestibular evaluation. Med. recs. Ex. 4, at 1. Petitioner was taking melatonin,

multivitamins, Topamax, and Vitamin B-12. She complained of an eating disorder, migraine

headaches, and vertigo. Petitioner gave a history that, over the prior three months, she had

episodes of debilitating headache and dizziness, as well as photophobia, nausea, and

phonophobia. She had tried several medications including Antivert and Depakene without

improvement. She had a normal head MRI. All lab work, including Lyme titer, was normal. Id.

Dr. Mouzakes wrote that petitioner’s physical examination was reassuring. Id. at 2. He ordered

that petitioner have an ENG study for further evaluation of her inner ear balance system. He also

ordered an audiogram to evaluate her middle and inner ear findings. Since petitioner had missed

more than three months of school, he would expedite the ENG testing. Id.

On May 13, 2009, petitioner had audiologic testing at the hearing center at Albany

Medical Center Hospital. Id. at 3. Under “Complaint” is the note that onset of symptoms of

dizziness and hypersensitivity to sounds and light was in February 2009 “correspond[ing] with

18

the administration of Gardasil vaccine” (although the vaccine was administered December 3,

2008). Id. Petitioner’s hearing test results were normal bilaterally. She had normal middle ear

function and normal outer hair cell function in the cochlea. Id.

On May 14, 2009, petitioner and her parents saw Dr. Nichter. Med. recs. Ex. 1, at 22.

Since her last visit to Dr. Nichter, she had seen a pediatric neurologist in Boston who thought

petitioner had a major psychological or psychiatric component to an ill-defined headache

syndrome. Id. The Boston doctor was not convinced petitioner even had migraines. Id.

Petitioner’s mother said petitioner’s headaches were better since Dr. Nichter first saw petitioner

in the ER, but they were quite variable. Id. On May 13, 2009, petitioner underwent vestibular

testing and she had a significant headache. Id. But, at other times, her headaches were better.

Id. She still had photophobia and phonophobia. Id. Normal sounds were extremely loud and

regular lights created major photophobia. Id. What Dr. Nichter found most pronounced was

petitioner’s abasia-astasia type gait (consistent with Dr. Sobeih’s diagnosis). Id. She would

lurch onto an arm or side of a chair or a wall. Id. At night, she would fall to the floor and sort of

get up to go to the bathroom. Id. She stated it was difficult for her to concentrate even with a

homebound school program for a few hours. Id. She was unable to walk, and had decreased

appetite. Id. Smell or fragrance of food was problematic. Id. at 22-23. On physical

examination, she bore weight but had swaying when she tried to walk. Id. at 23. However,

when Dr. Nichter swayed in the opposite direction while walking with petitioner, petitioner

seemed to adjust her swaying and, when he moved her arm in a different way, she also adjusted

accordingly. Id. When Dr. Nichter tested her sensation, petitioner said “sharp” when he placed a

dull object on her leg. Id. However, she was not consistent when he placed sharp and dull

objects on the same area. Id. Dr. Nichter prescribed Elavil and suggested decreasing Topamax.

Id.

On May 18, 2009, Dr. Kennette wrote a letter to petitioner’s high school, requesting

permission for petitioner to return to school on a graduated basis. Med. recs. Ex. 12, at 49.

Petitioner was trying to regain strength and ambulation, but might need to use a wheelchair

between classes and asked for accommodation for her to do so. In addition, Dr. Kennette asked

the school to work with petitioner’s family in obtaining any necessary academic support to make

up work she missed, including tutoring. Id.

On May 22, 2009, Jamie Steck, a pediatric physical therapist, evaluated petitioner. Med.

recs. Ex. 11, at 1. Petitioners’ parents and neurologist, Dr. Nichter, referred petitioner for

physical therapy because of parental ongoing concerns regarding her inability to walk

independently, unstable standing balance, weakness, and decondition noted since she had a sore

throat about three months earlier just prior to February School Vacation week. Id. A few days

after the sore throat, she complained of headaches. On Friday of that vacation week, petitioner

had significant sensitivity to light and sound, was exhausted, and complained of severe headache.

She was given migraine medication, but had no change. She subsequently went to Albany

Medical Center emergency room for severe headaches and was given a migraine cocktail

combination, but reacted to the medicine. She had frantic, anxious behavior, which led to her

19

being seen by a neurologist. Dr. Nichter prescribed a multivitamin, Topomax, and Elavil. She

continued to complain of headaches that were band-like on the lateral side of her head. Her

headache symptoms increased with neck hyperextension and rotation motions. Boston

Children’s Hospital neurology also evaluated petitioner and petitioner’s mother reported that the

hospital thought her symptoms were psychological. Petitioner had a very limited diet due to

sensitivity to smell and taste. She had lost 20 pounds since becoming ill. She had progressively

greater difficulty with balance and standing and got weaker as time passed.

Petitioner also said she could not make her legs do what she wanted them to do and they

felt as if they were going to give out on her. P-T Steck was concerned about petitioner’s

severely limited standing balance, inability to walk independently, decreased coordination, speed

of her limb motion noted more in the left leg than in the right, and decreased positional sense of

her left lower extremity. Dr. Mouzakes evaluated petitioner for vestibular problems, and ruled

out vertigo. She had a negative MRI and a normal EEG. Previous neurological examinations

did not reveal any neurologic involvement despite her inability to sustain balance independently

or to coordinate independent gait. Petitioner’s mother reported she had been “clutsy” as a child

and often injured herself playing soccer. She fractured her left ankle in August 2008.

Petitioner’s mother wondered if petitioner’s second Gardasil vaccination in December 2008

affected petitioner’s current status. Petitioner’s mother reported petitioner currently attended

school two hours a day while sitting in a wheel chair, and was exhausted upon return home.

Petitioner had been an A student and now had extreme difficulty reading and attending at school.

Petitioner reported that, while reading, things became blurry and words moved on the page. She

continued to have light sensitivity and her eyelids drooped over half of her eye throughout the

evaluation. Petitioner presented with a low affect and tended to look in a downward gaze with

her neck held in a forward flexed position with a slight rotation to the left. Despite being given

verbal prompts to encourage eye contact or hold her head up, she continued to posture her neck

down. During gross visual testing, petitioner was able to move her eyes in all directions, and P-T

Steck noted petitioner’s eyelid motion, but, at rest in sitting, her eyelids were lowered covering

half of her eyes. Id. Petitioner reported having a very difficult time keeping up with her school

work, and falling a lot at home. Id. Petitioner showed a decrease in the rate of her language

output and a slow reaction time in answering questions. Id. at 2.

Petitioner had muscle tone on the low end of normal throughout her trunk and

extremities. Id. When supported with maximum assistance in standing, petitioner laterally

glided and pushed her weight dangerously toward the right in dystonic motion. She presented

with ataxic arm and leg motions, especially in the left leg. During assisted standing, petitioner

held her left leg abducted and externally rotated at her hip, with the knee in hyperextension.

While attempting assisted steps, petitioner circumducted her left leg (circled her leg from the hip

to generate swing phase), showed plantar flexion (foot drop), and then hyperextended her knee

upon weight bearing with a flat foot placement that maintained her left ankle in a plantar flexed

position. Id. Petitioner had generalized muscle weakness throughout her trunk and extremities

due to deconditioning. During manual muscle testing, she had strength within functional limits

through her trunk and extremities at a good minus grade with the exception of left ankle eversion

20

and supination control, which was fair. Petitioner was able to lie down and sit up on her own,

but her movement showed decomposition, which was slow and mechanical like a puppet. She

showed incoordination in all functional movement. Her grip strength was weak, but her writing

skills remained intact. Id. P-T Steck recommended physical therapy three times a week. Id. at

4. She spoke with petitioner’s neurologist and pediatrician, and her neurologist would see her

again. Her symptoms and movement pattern were typical for cerebellar involvement. In

addition, her limited diet and nutrition had an effect on her symptoms. P-T Steck recommended

an ophthalmologist examine petitioner considering her visual concerns. She recommended home

exercises.

On May 28, 2009, petitioner and her parents saw Dr. Nichter on an urgent basis for

petitioner’s weakness, gait disturbance, and migraine. Med. recs. Ex. 1, at 25. A physical

therapist thought she had weakness in her left leg and foot drop. Petitioner’s mother stated she

did see a circumduction of petitioner’s left leg at times although there was no catch at the left

foot or stumbling. Petitioner would turn her left foot in at times. This was noticeable when

petitioner had significant activity or a stressful day. There was no new weakness in her arm or

weakness in her face. It was not clearly related to the severity of her migraines. There was no

new ataxia. If there were a social event where music played, petitioner’s headache would be

quite severe. She used sunglasses a bit less now than previously. She had stopped Topamax and

vitamin B2. Id. She was taking magnesium, multivitamins, and Elavil. Id. at 25-26. Physical

examination showed full strength in her arms, but occasional give-away weakness in the

quadriceps and hamstrings. Id. at 26. She had variable responses to position sense, but she was

correct at least 75 to 85 percent of the time. Id. Vibratory sense was normal. Id. When

petitioner walked, she still lurched to one side or the other. Id. At times, she would invert her

left foot, but there was never a foot drop. Id. The foot inversion was intermittent, i.e.,

inconsistent. Id. Dr. Nichter assessed petitioner’s migraines and photophobia as a little bit

better. Id. Her gait remained in the abasia-astasia category. Id.

On June 7, 2009, petitioner had a brain MRI done because of her headaches. Med. recs.

Ex. 574. Her brain MRI was negative. Id.

On June 25, 2009, petitioner saw Dr. Hilaire J. Meuwissen, an allergist and

immunologist. Med. recs. Ex. 573, at 1. Petitioner’s illness began approximately February 15,

2009 with a severe sore throat and fatigue, low-grade temperature, and swollen glands for about

a week, about two months after she received her second Gardasil vaccination. Id. No doctor

made a definite diagnosis after migraine therapy failed. Petitioner told Dr. Meuwissen that

concentration was difficult and reading not easy because words moved back and forth and

became larger and smaller haphazardly. Id. Petitioner walked close to the wall with support

from the wall and reported she had many bruises from bumps and almost falling. Id. at 2. She

looked pale and distressed and wore sunglasses because of extreme sensitivity to light. She was

very sensitive on percussion of her frontal and maxillary sinus. Dr. Meuwissen’s assessment was

that petitioner might have a neurologic condition that her upper respiratory infection in February

caused. Id. There was a remote possibility she might have a variant form of Guillain-Barré

21

syndrome secondary to Gardasil vaccination although the interval between vaccination and onset

was long. Id.

On June 30, 2009, petitioner’s antinuclear antibody (“ANA”) was 1:640 in an atypical

discrete speckled pattern. Med. recs. Ex. 8, at 17.

On July 6, 2009, petitioner and her parents saw Dr. Nichter. Med. recs. Ex. 1, at 28.

Petitioner had undergone a brain MRI and MRA, both of which were normal. Her family said

petitioner was 30 to 40 percent better. Her headaches were fewer, lasting an entire day or a few

hours. She was able to walk more upright, although she still needed support. She could tolerate

sunlight and her appetite was better. Her mood and disposition were better. She complained of

belly pain twice a week. Id. On physical examination, her strength was 5/5 with occasional

giveaway weakness. Id. at 29. She had less lurching gait. She took two to three steps on her

own without leaning as much. There was no foot drop or involuntary movement. Dr. Nichter’s

assessment was that petitioner’s migraines and abasia-astasia were both improving. Muscle

strength testing was quite variable as she had giveaway weakness but sometimes she generated

more force. Id.

On July 14, 2009, petitioner started physical therapy with Adrienne Fil at Sunnyview

Rehabilitation Hospital. Med. recs. Ex. 11, at 6. According to Ms. Fil’s record of August 13,

2009, after 14 P-T sessions, petitioner’s “physical presentation with mobility continues to be

incongruent with objective measurements.” Id. at 8. Ms. Fil questioned the possibility of

petitioner having a conversion disorder. Id. When Ms. Fil drew less focus to petitioner’s

impairments, petitioner had spontaneous improvement in her lower extremity function. Id. at 8-

9. Petitioner’s mother became concerned about petitioner continually blacking out and

collapsing. Id. at 9. During the P-T session, petitioner was standing for at least 50 minutes of

the hour-long session without difficulty while doing activities. Id. Ms. Fil was aware that

petitioner was referred for a psych intervention earlier in her diagnosis and petitioner became

physically worse. “Perhaps with her physically improving now she may be more open to

counseling. . . .” Id. Ms. Fil mentioned this to petitioner’s parents, but not to petitioner directly.

Id.

On July 20, 2009, petitioner had a nerve conduction study (“NCS”), electromyography

(“EMG”), and F Wave test done to determine if she had inflammatory neuropathy. Med. recs.

Ex. 9, at 6. Dr. Matthew J. Murnane concluded the tests were normal without evidence of a

peripheral neuropathy. Id. at 7.

On August 10, 2009, petitioner’s father wrote Dr. David Cornbluth, stating that petitioner

in February 2009 developed what seemed to be a viral illness two months after a Gardasil

immunization. Med. recs. Ex. 3, at 3. This rapidly progressed to severe headaches, photophobia,

phonophobia, complete loss of appetite, and a balance/gait disturbance. A multitude of testing

was unrevealing. She had been out of school since February with home tutoring since then. She

would sit in a dark, quiet room, unable to tolerate playing her flute, with no stamina for any

22

activity, although previously she had been an avid flute player and on the soccer and track teams.

Standard migraine prescriptions were not helpful, including IV Depakote. Previously, petitioner

was wheelchair-bound or wall walking only. Now she did some walking on her own.

Petitioner’s father asked if Dr. Cornbluth would be willing to see petitioner. Id.

On August 12, 2009, Dr. Kennette recorded petitioner’s 15 year and six month old visit.

Med. recs. Ex. 12, at 50. Petitioner was doing physical therapy at Sunnyview with Adrienne Fil

at least three times a week since the end of June. Petitioner’s nerve conduction and EMG studies

were normal. Id. Petitioner’s sensation was stronger on her right. She was currently taking

Periactin, multivitamins, and Elavil. She had gained two pounds. Her blood pressure was

108/64. She weighed 113 and ¼ pounds. Her height was 5’5 and ¼ inches. Her BMI was 18,

which put her in the 10-25% group. She was wearing sunglasses. She had cool, bluish feet. Her

left calf was smaller than her right calf. Her proximate strength was 4+/5. Petitioner had

ongoing issues with gait, headaches, photophobia, hyperacusis, 14 change in taste, and food

aversion for five to six months. Id. There was no specific diagnosis made up to that date.

Petitioner’s parents were considering consulting with Dr. David Cornbluth in Baltimore. There

was a follow up with the neurologist the following week. Perhaps petitioner should have a

lumbar puncture. Id.

On August 17, 2009, petitioner and her parents saw Dr. Nichter. Med. recs. Ex. 1, at 31.

Petitioner underwent EMG and nerve conduction studies, which were normal. Since Dr. Nichter

last saw petitioner on July 6, 2009, she had had “enormous variability.” Id. She could walk on a

board, walk independently, and, on one occasion, walk a few miles. The headaches were

variable, from mild to so severe she was weeping. She had photophobia and phonophobia. She

had a significant decrease in appetite. Petitioner’s father was researching vaccine-related

individuals. Id. On physical examination, petitioner could walk and move from chair to

standing. Id. at 32. She took several steps walking on her own and leaned on the side of the wall

as she moved from the clinic to the checkout area. She did not have footdrop. There was an

occasional inturning of her left foot. Id. Dr. Nichter’s assessment was that petitioner was

improving and her gait was significantly better. She was down to one severe headache a week.

He increased her Elavil. He also recommended she do five sit-ups a day and continue physical

therapy three times a week, one of which times was aquatherapy. Id.

On August 25, 2009, petitioner’s parents met with Dr. Steven Sandler, 15 a pediatrician

and psychiatrist at Albany Medical College, to find out if petitioner’s multiple physical

14

Hyperacusis is “exceptionally acute hearing; the hearing threshold being unusually low. It may or may

not be accompanied by pain.” Dorland’s at 886.

15

Dr. Steven Bruce Sandler was board-certified in psychiatry on October 30, 1990. This board

certification is valid indefinitely. He was board-certified in child and adolescent psychiatry on November

11, 2000 through December 31, 2010, but his status as of January 23, 2017 was not board-certified in

child and adolescent psychiatry. https://application.abpn.com/verifycert/verifyCert.asp?a=1&u=1# (last

visited: Jan. 23, 2017).

23

symptoms were psychological in origin. Petitioner was not with her parents at this first

conference with Dr. Sandler. Med. recs. Ex. 7, at 1. Petitioner’s parents were concerned that

Gardasil vaccination in December 2008 may have caused her whole problem. In February 2009,

petitioner developed a viral illness with headache and malaise. She also developed photophobia,

phonophobia, and annoyance with smells. After two or three weeks, she had a gait problem. A

number of physicians saw her. Her strength and physical examinations were normal. Her testing

was normal except for an elevated antinuclear antibody (“ANA”). A presumptive diagnosis was

migraines. Petitioner became so incapacitated that she had been in a wheelchair and out of

school since February. Petitioner seemed to be depressed and had lost weight, mostly because

the smell, taste, and consistency of food troubled her. Id. A child neurologist at Boston

Children’s Hospital felt the cause might be psychological. A physical therapist, Adrian Fil, at

Sunnyview Hospital, noted petitioner’s sensitivity to sound and light as well as her gait had

improved slightly, but Ms. Fil pointed out to petitioner’s parents that petitioner’s examination

was inconsistent from one day to the next. Id. Petitioner was a high honors student, and

remained a high honors student even while at home and studying with a home tutor. She had

trouble reading and had to isolate one line at a time with an index card. Nevertheless, she read

three books on her own in the summer. Id. Petitioner told her parents she did not want to go

back to her high school because of the students and their reaction to her illness. Id. Petitioner

took Imitrex, hydrocodone, Benadryl, intravenous Depakene, Maxalt, Compazine, and B

vitamins for migraine headaches. She was currently on Amitriptyline, Periactin, and

multivamins. Id. Petitioner had an older brother and a younger sister. Id. at 2.

On September 1, 2009, petitioner saw Dr. Sandler. Id. at 3. He notes: “She says it all

began with a sore throat in February. Then, she developed flu symptoms, a headache,

wobbliness, and a sense that the halls were spinning at school. The headache has persisted ever

since. It is mostly bitemporal but sometimes she feels it at the back of her head too.” The

quality of the headache varied. Sometimes it felt like a knife, but at other times it pulsed or

throbbed or felt like pressure. It never went away and varied from 2/10 to 10/10. She said she

wanted to go back to school (the opposite of what petitioner’s parents told Dr. Sandler on August

25, 2009). Id. at 3. Petitioner also had photophobia and phonophobia. Id. Petitioner told Dr.

Sandler that she had a headache for a week in the seventh grade, which was diagnosed as a

migraine and which resolved completely. Id. She also told Dr. Sandler that she was quite happy

in February 2009 and had no particular stressors. Id. Besides her headache, and the annoyance

of loud or high-pitched sounds and of light, petitioner said food tasted weird to her, being either

too salty or too bitter. Id. Her appetite had declined and she had lost weight. Petitioner said she

and her mother were best friends, but she had not seen much of her father growing up because he

worked long hours as a physician. Petitioner denied depression (the opposite of what petitioner’s

parents told Dr. Sandler on August 25, 2009). She said she woke up a lot at night. Id.

Dr. Sandler noted that petitioner came to the office with the assistance of her mother

because she was unstable walking on her own. However, she did walk unassisted as she left Dr.

Sandler’s office, but walked very slowly and not steadily. He noted she was alert, oriented, very

cooperative with the interview, and made good eye contact. Her speech was clear and normal in

24

flow and volume. Her thought process was entirely normal and she appeared alert and oriented

with normal intellectual capacities. Dr. Sandler summarized his impression. Petitioner’s parents

believed her symptoms since February 2009 were due to a Gardasil immunization. She sounded

quite eager to go back to school and join her friends and activities. Dr. Sandler had “no

suspicion that she is malingering 16 or trying to play a sick role.” Id. He did not suspect her

symptoms were psychosomatic. 17 She read several books that summer with great effort. Id. He

offered her a session of hypnosis to alleviate her headache pain and she agreed to come back in a

week to do that. Id. at 4. He concluded that petitioner did not seem to be suffering from

significant anxiety or depression that might exacerbate her symptoms or worsen her perception

of physical pain. Id.

What is noticeable about Dr. Sandler’s opinion is he has no notation that he ever read

petitioner’s medical records including the physical examinations that other physicians performed

on petitioner, or performed his own physical examination of her. (He could not have seen

petitioner’s father’s summary of petitioner’s medical records because petitioner’s father did not

create it until a year after this visit.18) Moreover, he never comments about the discrepancy

between petitioner’s parents’ statements and petitioner’s own statements. For example,

petitioner’s parents told Dr. Sandler on August 25, 2009 that petitioner was depressed. Petitioner

denied depression when she saw Dr. Sandler on September 1, 2009. Petitioner’s parents told Dr.

Sandler on August 25, 2009 that petitioner did not want to go back to school because of her

classmates’ reaction to her illness. On September 1, 2009, petitioner conveyed the impression

that she was quite eager to return to school, rejoin her friends, and resume activities. These

discrepancies passed without Dr. Sandler’s comment.

On September 8, 2009, petitioner and her parents saw Dr. Nichter. Med. recs. Ex. 1, at

34. Using Ativan gave her a paradoxical reaction where she was seeing bugs and it did not

assuage her headache. Id. Her headaches occurred at least three times a week and Elavil was not

helpful. Excedrin Migraine with caffeine seemed to wire her up as well. Therapy was going

well. She could walk more independently and consistently. Her left leg seemed to turn in. She

saw Dr. Sandler who did not think petitioner was having a conversion reaction. He was going to

try hypnosis on her. Id. On physical examination, she had variable results in her legs. Id. at 35.

Sometimes she had giveaway weakness. At other times, the left foot would turn in. There was

no ataxia. Dr. Nichter’s assessment was that petitioner continued to improve slowly. She had

16

Malingering is “the willful, deliberate, and fraudulent feigning or exaggeration of the symptoms of

illness or injury, done for the purpose of a consciously desired end.” Dorland’s at 1099.

17

Psychosomatic disorder is “a disorder in which the physical symptoms are caused or exacerbated by

psychological factors, such as migraine headache, lower back pain, or irritable bowel syndrome. The

synonym psychophysiologic disorders, used in previous official nomenclatures and defined as ‘physical

disorders of presumably psychogenic origin,’ has been replaced in DSM-IV by the more neutral phrase

psychological factors affecting physical condition, which may be applied to any physical condition

judged to be adversely affected by one or more psychological or behavioral factors, and is subtyped on

the basis of the specific factors involved.” Dorland’s at 552.

18

See Exhibit AAAAAAA, medical history dated August 1, 2010 prepared by petitioner’s father.

25

some dizziness upon standing which was separate from headache. Dr. Nichter prescribed

hypnosis with the psychiatrist. Petitioner’s parents were not interested in acupuncture. Id.

Also, on September 8, 2009, petitioner again saw Dr. Sandler. Med. recs. Ex. 7, at 5.

Her headaches persisted and were currently 4-5/10 in severity. Dr. Sandler diagnosed petitioner

with mood euthymia. 19 He used hypnosis, guided imagery, and Thought Field Therapy.

Petitioner had some relief (her headache was then 4/10) with guided imagery. His plan was that

petitioner would have no further visits unless needed and she would practice at home. Id.

On September 16, 2009, Dr. Nichter wrote a Transfer Summary for the pediatric

Emergency Room. Med. recs. Ex. 1, at 38. The history he wrote was that petitioner developed

severe migraine in February 2009 after a sore throat. Id. In light of some mild depression, she

saw Dr. Sandler who tried hypnosis with minimal or no success. Id. Petitioner recently went to

school and was able to persist until around 1:00 p.m. but not on the subsequent day. Id. She had

severe headaches and on the prior night, which were associated with phonophobia and

photophobia. Id. There had been a question of numbness and tingling in the left leg. Id. When

the headache was less, her leg was nearly normal. Id. She did reasonably well in school. Id.

For petitioner’s physical examination, petitioner was in a dark room with her parents. Id. Dr.

Nichter’s assessment was that petitioner had migraines that might be related to Gardasil

administered one or two months before the onset of her migraines. Id.

On September 16, 2009, at 1:30 p.m., petitioner went to the Albany Medical Center

Emergency Room where she saw Dr. Cha Pranati. Id. at 40. Petitioner’s history was gait

disturbance and migraine-like headaches. Dr. Pranati writes, “[I]t was thought that these

complaints might have been secondary to her Gardasil vaccine, which was given in December

2008. She started with gait disturbance in February 2009. According to mom, she was not able

to walk without significant support February 2009 to July 2009.” Id. Petitioner’s headache was

persistent accompanied by photophobia and phonophobia. Id. Medical staff performed multiple

investigations, including MRI and MRA, and everything was normal. Id. Her ANA was high at

1:640, but her ds-DNA 20 was normal. Id. Petitioner came to the ER with more severe headache

since school opened. While her appetite had decreased, her photophobia and phonophobia were

more pronounced. Petitioner’s mother said they had tried many different medications for

migraine and nothing worked very well for petitioner. Petitioner reported her pain was 9-10/10.

Petitioner also complained of an abnormal sensation in her left leg, but she was able to walk

without support. Petitioner had a history of two ankle fractures in the past. Id. Petitioner was on

Elavil, Periactin, and Endural. Id. at 40-41. On physical examination, she was lying in bed with

the lights switched off. Id. at 41. Petitioner had full strength and no sensory deficit. Her

aggravated migraine-like headache had persisted for four to five days. All her investigations had

been negative. Dr. Dorothy T. Damore, a pediatric neurologist assisting in the Emergency

19

Euthymia is “a state of mental tranquility and well-being; neither depressed nor manic.” Dorland’s at

655.

20

“Ds-DNA” is double-stranded DNA. Dorland’s at 568.

26

Department, recommended doing a lumbar puncture to rule out pseudotumor cerebri. Petitioner

received 5 mg of Reglan IV and 1000 mg of Depacon and the lumbar puncture was performed.

One hour after receiving Reglan, petitioner reported minimal improvement. Id. Dr. Pranati

diagnosed petitioner with headache, likely migraine. Id. at 42. Dr. Pranati did a physical

examination which showed petitioner had 5/5 strength in her arms and legs and no sensory

deficit. Med. recs. Ex. 553, at 56. Dr. Nichter, in a note to the pediatric emergency department,

dated September 16, 2009, commented that the stress of school might have brought out the worst

again in petitioner’s migraines. Id. at 59.

On September 30, 2009, the physical therapist Adrienne Fil at Sunnyview Rehabilitation

Hospital noted that petitioner had had 29 P-T sessions and had shown functional gains, but had a

recent setback after a significant increase in her headaches resulting in her going to the

emergency room September 16, 2009. Med. recs. Ex. 11, at 10. Petitioner’s mother said

petitioner had a bad reaction to pain medications with no relief in her pain. Petitioner’s lower

extremity function, gait quality, and balance declined. Id. Ms. Fil noted that petitioner had low

tone with functional mobility with a floppy upper body and left lower extremity despite having

strength on muscle testing. Id. at 12. Petitioner had depression in her earlier treatments,

frequently reporting she was unable to sleep and had no appetite. Id. As her function improved,

she was more social and had better endurance. But with the recent setback, she appeared more

depressed. She continued to be unable to attend a full day of school due to headaches and had an

aide for safety while negotiating between classes. Id.

On October 6, 2009, Dr. Nichter wrote petitioner’s pediatrician, Dr. Kennette, stating he

saw petitioner and her parents for petitioner’s migraines and gait disturbance. Med. recs. Ex. 1,

at 44. The history he recounts is that petitioner developed a sore throat and afterward a profound

migraine at the end of February 2009 and went to the emergency room in early March 2009. She

had received a Gardasil vaccination a few weeks earlier. Testing included nerve conduction and

EMG to rule out Guillain-Barré syndrome. She also had MRI, MRA, and lumbar puncture, the

results of which were also unremarkable. Ativan was unsuccessful and she continued to have

headaches, which were diffuse, ranging from 4/10 to 8/10. There were no clear precipitators.

Elavil was discontinued and she was on Periactin, Propranolol, and Cymbalta. Cymbalta had not

affected the severity of the headaches. Dr. Nichter was seeing petitioner now for syncopal

episodes occurring at least five to seven times a week during which she would stand up and walk

toward the kitchen or another location, have black spots, and be on the floor. She was a bit

tachycardic after the event. With the introduction of the Propranolol, these events significantly

increased. Her gait was not as efficient after the lumbar puncture as before it, but she was

improving. The lumbar puncture was benign and the opening pressure was 16. Dr. Sandler did

not see any pathologic or psychological issues. Id. During her physical examination, petitioner

wore sunglasses and lay her head on her mother’s lap during most of the visit. Id. at 45.

Petitioner was able to jump on two feet. She balanced on one foot for about ten seconds. Her

gait was slow, but not lurching. Dr. Nichter’s assessment was that petitioner’s gait continued to

improve. Propranolol may have exacerbated her syncope. Id. There was no clear successful

intervention in her headaches. Id. at 46. His plan was to decrease the Propranolol and stop at

27

three- to four- day intervals, continue Cymbalta and Periactin, and to make an appointment with

Dr. Argoff to facilitate any new or different pain management such as Botox or acupuncture. Id.

On October 21, 2009, petitioner’s mother called Dr. Kennette’s office to complain that

petitioner had fever, chest pain from coughing, and a migraine-like headache. Med. recs. Ex. 12,

at 54. Petiitoner’s mother was concerned because petitioner’s headaches were getting worse.

She wanted to speak with Dr. Kennette. Petitioner’s fever the day before was 100.4 degrees.

That day it was over 101 degrees. She had a sore throat and cough for over two days, upper

chest pain, severe headache with the cough, and “faints” (the notetaker put “faints” in quotation

marks) when she tried to stand up. Her heart rate ranged from the 90s to 144 with blood pressure

90s/70s. Dr. Kennette instructed the mother to seek emergency room care. Id.

On October 23, 2009, petitioner and her parents saw Dr. Joel M. Kremer, a

rheumatologist. Med. recs. Ex. 10, at 1. They gave a history of a six-week interval between

petitioner’s second Gardasil and the onset of her symptoms of sore throat and headache. Id.

Petitioner’s mother has Raynaud’s. 21 Id. at 2. Dr. Kremer noted that the etiology of petitioner’s

severe headaches and various neurologic deficits was obscure at that time. He noted a five-page

summary from VAERS (Vaccine Adverse Events Reporting System) comparing events

following Gardasil vaccination vs. Menactra vaccination through November 30, 2008. The

summary seemed to indicate that there was an increased incidence of general reactions to

Gardasil compared to Menactra, specifically pain, paralysis, syncope, vasculitis, and lupus.

There were 28 cases of lupus reported following Gardasil compared to six lupus cases reported

following Menactra. Dr. Kremer gave this VAERS summary to petitioner’s parents. He

scheduled further tests: a repeat ANA, CH50, DNA antibody, C3, C4, FSH, LH, cardiolipin

antibody, lupus anticoagulant, and cryoglobulins together with a metabolic panel and routine

urine. Id.

Also on October 23, 2009, in the evening, petitioner went with her parents to Albany

Medical Center Emergency Department, complaining of difficulty breathing at home. Med. recs.

Ex. 553, at 52. Over the last three days, she had some increasing congestion, including bringing

up a productive sputum. That day, however, she began having a fever and started Tamiflu.

However, her cough persisted, similar to a croup cough, and she had stridorous respirations to

the point she was having difficulty breathing. Upon arrival in the Emergency Department, her

breathing improved significantly and her parents stated that she had significant improvement on

the way to the Emergency Department. Id. Dr. John Burton did a physical examination and

found some mild tonsillar hypertrophy to the oropharynx, but no exudate or erythema. Id. at 53.

Oxygen saturation was normal. She did not have any stridor or retractions. Her lungs were clear

without wheezes or rales. Dr. Burton diagnosed petitioner with viral syndrome and tracheitis.

21

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

and relieved by heat; it is usually due to an underlying disease or anatomical abnormality. When it is

idiopathic or primary it is called Raynaud disease.” Dorland’s at 1430.

28

He states in the medical record, “In the Emergency Department, the etiology of this patient’s

difficulty breathing over the last 2 days and particularly this evening was somewhat unclear,

although this seems to be consistent with a history of a viral tracheitis.” Id. A chest x-ray was

normal and she had a normal epiglottis and normal retropharyngeal tissues. Id.

On October 27, 2009, petitioner’s hexagonal phospholipid was 7.3 whereas less than 6.2

was negative and greater than 6.2 was positive. Med. recs. Ex. 8, at 5. On the same date,

petitioner had an abnormal lupus anticoagulant panel. Id. Petitioner’s ANA was 1:1280 with a

speckled pattern. Id. at 17.

On November 5, 2009, Dr. Charles E. Argoff, a neurologist with special qualifications in

pain management, wrote a progress note. Id. at 47. The history was that petitioner was in her

usual state of health until the end of February 2009 when she began to experience a daily

headache. “This appeared to be in association with her use of Gardasil. . . .” Id. [Dr. Argoff’s

record does not reflect that the end of February is nearly three months after December 8th when

petitioner received Gardasil.] Testing included lumbar puncture, MRI, MRA, and

“electrophysiological studies because she was at times unable to walk.” Id. Dr. Argoff writes he

spent over 45 minutes in face to face contact with petitioner in the presence of her parents. To

date, all diagnostic studies were negative. Petitioner currently complained of daily headaches

with photophobia, severe pounding, sharp and stabbing type of headache across her entire head,

and inability to function as well as to attend school. In addition, when she took certain

medication, she had difficulty walking and had a dystonic reaction to Reglan when the ER at

Albany Medical Center gave it to her. More recently, she was prescribed Ambien to help her

sleep and she had a similar reaction. Today, petitioner had difficulty walking in Dr. Argoff’s

office and her parents told him this difficulty occurred frequently. She had been treated with a

variety of agents including Cymbalta, Topamax, amitriptyline, Aleve, Periactin, Ativan,

Propranolol, magnesium, multivitamins, and vitamin B2 and nothing had helped her. Petitioner

complained of words not appearing as words when she looked at them, but she had not seen her

ophthalmologist recently. She had not seen a neuro-ophthalmologist either. A pediatric

neurologist at Boston Children’s Hospital told her that her complaints were somatic, but did not

perform any diagnostic studies. Dr. Sandler, a psychiatrist at Albany Medical Center, saw her

but did not feel she had any significant psychiatric issues. Id. Petitioner had headaches daily.

Id. at 48. On physical examination, petitioner was able to walk normally, but unable to perform

tandem heel and toe gait comfortably because she felt unsteady. However, the Romberg sign

was negative. Dr. Argoff’s impression was that petitioner had chronic neurological symptoms of

uncertain etiology. She appeared to have apraxic 22 difficulties from the motor function point of

view, but her difficulty with gait was difficult to diagnose. He recommended that petitioner see

Dr. Changizi, one of his movement disorder colleagues, for evaluation of any movement

disorder. He also recommended that petitioner see Dr. Rheeman, a neuro-ophthalmologist,

because of petitioner’s difficulty reading words. Petitioner was already scheduled to see Dr.

22

Motor apraxia is “impairment of skilled movements that is greater than or different in form from that

caused by weakness of the affected parts; the patient appears clumsy rather than weak.” Dorland’s at 121.

29

David Cornblath at Johns Hopkins University because of his involvement with the Merck

Gardasil studies. Dr. Argoff thought petitioner’s headaches might be better controlled with the

use of botulinum toxin chemosurgical therapy or specific Botox injections. But he deferred this

recommendation. Id.

On November 8, 2009, petitioner saw Dr. Charles Rheeman, a neuro-ophthalmologist, to

evaluate petitioner for difficulty in reading. Med. recs. Ex. 15, at 2. She gave a history that she

developed numerous symptoms in February 2009. Id. She received two doses of Gardasil, the

second in December 2008. Id. Since February 2009, she had had daily severe headaches

associated with photophobia and phonophobia. Id. She also developed problems with walking

and was undergoing physical therapy. Id. Her main visual complaint was difficulty reading

because the words “float.” Id. She used a paper for alignment in order to read. Id. She also had

trouble sleeping and eating, having lost about thirty pounds. Id. She reportedly had a negative

MRI and negative lumbar puncture. Id. She had taken numerous migraine headache medicines

without relief. Id. Dr. Rheeman stated that petitioner’s entire eye examination was normal. Id.

He wrote in a letter to Dr. Charles Argoff:

I do not have a good explanation for why she is having trouble

reading. At this point, I could not entirely rule out a non-organic

cause. For example, as far as her difficulty ambulating is

concerned, you told me you did not find any weakness or

numbness on exam. She could barely walk without her mother’s

assistance today. However, the patient’s mom told me [petitioner]

was able to walk about two miles trick or treating on Halloween

night.

Id.

On November 10, 2009, petitioner and her parents went to Johns Hopkins University to

see Dr. David Reid Cornblath, a neurologist, about petitioner’s headaches because he consulted

with Merck regarding Gardasil. Med. recs. Ex. 3, at 7. Petitioner’s father sent in advance a 100-

page notebook to Dr. Cornblath on Gardasil adverse reactions. Id. Dr. Cornblath recounted

petitioner’s short series of headaches in 2007 after a soccer game. The headaches were mild and

resolved, and she had a negative head MRI. Petitioner received two Gardasil vaccinations, the

first on August 26, 2008, and the second on December 3, 2008. She was well until about

February 15, 2009 when she developed a sore throat, fatigue, low-grade fever, and swollen

glands, lasting a week. Id. After that, she had headaches, which worsened and were associated

with nausea, photophobia, phonophobia, and loss of appetite. Id. Her pediatrician Dr. Kennette

diagnosed her on February 26, 2009 with migraine and prescribed Lortab and Imitrex. Id.

Symptoms continued and, by March 2009, petitioner developed a profound inability to maintain

balance in order to walk, although never having true vertigo or nystagmus. Id. Symptoms

continued with severe unremitting headaches for nine months. Id. Over that time, she had

extensive testing including MRI and spinal tap, both of which were normal. She saw a number

30

of physicians, none of whom was able to find her abnormal neurologically. Id. Her grades were

excellent (high 80s to 90s except for math where she had a 99), whether home-schooled or back

at school. Id.

Petitioner’s laboratory studies were normal for the following tests: CBC, cryoglobulins,

PT, PTT, hexagonal phospholipids, Russell viper venom, CSF (0 cells, glucose 56, protein 22),

CMP, CK, iron, homocysteine, quantitative immunoglobulins, CRP, serum immunofixation,

FSH, LH T4, TSH, antithyroglobulin antibodies, thyroid peroxidase antibodies, vitamin D, Lyme

C6, EBV, cardiolipin, double-stranded DNA, C3, C4, T-cell subsets, and total complement. Id.

Her ANA on October 27, 2009 was 1:1280. On April 6, 2009 and June 30, 2009, her ANA was

1:640. MRA done on June 9, 2009 was normal. MRA of the neck done on October 13, 2009

was normal. MRV done on March 18, 2009 was normal. Brain MRIs done on March 18, 2009

and June 9, 2009 were normal. A nerve conduction study of July 20, 2009 was normal. Id. at 8.

Petitioner filled out a new-patient questionnaire for Dr. Cornblath. Petitioner listed the

following symptoms: (1) altered taste and smell; (2) change in appetite; (3) weight loss; (4)

difficulty sleeping; (5) fatigue; (6) neck pain; (7) joint pain; (8) difficulty concentrating; (9)

dizziness; (10) headaches; (11) lethargy; (12) balance problem; (13) blurred vision; (14) double

vision; (15) trouble concentrating; (16) numbness in legs; (17) poor balance; (18) poor

coordination; (19) trouble walking; (20) weakness in legs, left more than right; (21) fainting; (22)

abdominal pain; (23) hoarseness; (24) shooting pains; (25) fainting spells; and (26) trouble with

smell. Id.

Her medications included: Topamax (no effect), Amitriptyline (no effect), Propranolol

(no benefit but petitioner developed presyncope); dexamethasone (no effect), Cymbalta (no

effect), Ambien (violent hallucinations), and Reglan (created intense anxiety). Id.

On physical examination, Dr. Cornblath found petitioner’s gait striking. Id. at 9. When

she walked with her mother, petitioner held on quite tightly and appeared as though she were

going to fall. Id. But when petitioner walked with Dr. Cornblath, she hardly required any real

assistance. Id. She could rise from a chair without the use of her hands. Id. Dr. Cornblath’s

assessment was that, after a viral infection in mid-February, petitioner developed what became

incapacitating daily headaches. Id. Dr. Cornblath stated that he discussed Gardasil with

petitioner and her parents:

I have explained to the family why I do not believe her current

symptoms can be related to the Gardasil vaccine. We have gone

over the concepts of biological possibility and the kinds of events

of a neuroimmune nature that are known to occur following

vaccines at a low incidence. Her symptoms began two months

after vaccination and were closely in time follow[ing] some sort of

viral infection. Thus, I do not believe there is any relationship

31

between her current symptoms and her receipt of the Gardasil

vaccine.

Id. Dr. Cornblath wrote that the cause of petitioner’s headache remained unknown. He

pondered whether the dosages of petitioner’s various medications had been high enough to work.

He suggested that petitioner talk with her physicians about returning to those medications and

raising their dosage. Dr. Cornblath spoke with Dr. Nichter who told him that, in treatment of

pediatric migraine, low dosage is standard practice. Id.

Dr. Cornblath wrote:

There is no clear neurological explanation for her gait dysfunction.

This has been noted multiple times in her past records where her

gait has been called “astasia-abasia.”

At the end of the interview, [petitioner] asked me if I thought she

was crazy. I told her that she had a serious set of symptoms for

which the doctors had been unable to find the cause. However, in

most people of her age who have a normal neurologic examination

and extensive normal neurological testing, she has an excellent

prognosis for her recovery. I explained . . . however that a

recovery of her medical condition requires close cooperation with

her [doctors] and a positive attitude on her part.

Id. Dr. Cornblath recommended biofeedback as a possible help in a conversation with Dr.

Nichter. Dr. Cornblath noted that petitioner’s parents were still convinced that Gardasil caused

petitioner’s problems. Id.

On November 13, 2009, Dr. Kremer, the rheumatologist, spoke with petitioner’s mother

and then petitioner’s father. Med. recs. Ex. 10, at 3. Petitioner had a positive ANA of 1:1280

speckled and a weakly positive hexagonal phospholipid neutralization test with a norm INR,

negative anti-cardiolipin antibody, and negative beta 2 glycoprotein 1. Dr. Kremer told both

parents that he found it difficult to connect these lab test results with petitioner’s clinical picture

given the multiple negative imaging studies she had. He recommended they see Dr. Michelle

Petrie at Johns Hopkins Medical Center in Baltimore. They mentioned they had just returned

from Johns Hopkins after seeing Dr. Cornblath, a neurologist, who suggested increasing

petitioner’s dosage of Topamax. Dr. Kremer said he would e-mail Dr. Petrie to see if she would

consider seeing petitioner as an additional consultant. Id.

On November 17, 2009, petitioner and her parents visited Dr. Nichter. Med. recs. Ex. 1,

at 50. Among petitioner’s other tests, her sedimentation rate and C-reactive protein were normal.

Petitioner and her parents met Dr. Cornblath in Baltimore, and he did not feel that Gardasil was

related to her present clinical condition. In a personal phone call Dr. Cornbluth made to Dr.

32

Nichter, “he stated he thought most of the findings were not physiologic.” Id. Petitioner also

saw a neuro-ophthalmologist who found her entire eye examination was benign. He raised

questions as to stressors in petitioner’s life. Petitioner and her parents met with Dr. Sandler who

felt she did not have any major psychologic or psychiatric dysfunction, and recommended

trazadone for sleep. But after taking Ambien once and having almost a hallucinatory response in

terms of seeing death in her brother, petitioner was quite agitated and confused. Petitioner and

her parents saw Dr. Argoff who recommended Botox injections but also recommended they see a

movement disorder specialist, Dr. Changizi, “but the family did not wish to go that route.” Id.

Petitioner’s headaches waxed and waned. At times, she did well. For example, she walked most

likely five miles during a Halloween event. She seemed fatigued, but still walked over three to

five miles. After her experience with Ambien, she had a severe headache. Id. Of note, Periactin

did not result in significant improvement. Id. at 50-51. Propranolol resulted in a syncopal-like

process. Id. at 52. Cymbalta made no difference. On physical examination, petitioner’s

weakness seemed quite variable. At times, she was weaker on the left than on the right, but it

was inconsistent. “She could barely walk during the examination, and yet when coming in, she

walked from the parking lot to the sitting room without any assistance.” Id. She could not jump

on two feet without some assistance. Id. at 51-52. There was some decrease in vibratory sense

at the left toe, but it was very inconsistent. Id. at 52. Dr. Nichter’s assessment was that

petitioner’s gait overall was much improved compared to three to four months previously, but

there was a dip approximately two months ago. Headache continued to be quite a serious

problem. Syncopal events had subsided. Id. Petitioner was not on any medicines and Dr.

Nichter did not recommend that she go on any medicines. In light of petitioner’s hair falling out,

he recommended that she take a good multivitamin with minerals including selenium. He

recommended that petitioner and her parents discuss with Dr. Kennette, petitioner’s pediatrician,

a psychiatric evaluation and specifically any medications that would be a mild mood elevator.

Id.

On December 4, 2009, petitioner went to Dr. Michelle A. Petri and Dr. Saru Sachdeva at

Johns Hopkins University for a second opinion regarding her headaches and positive ANA.

Med. recs. Ex. 5, at 1. Petitioner told Dr. Petri that she had a short series of headaches in 2007

and, on February 15, 2009, she developed a sore throat, low-grade fever, and swollen lymph

nodes, lasting for about one week. Id. She also had mild headaches at that time. Id. One week

later, on February 21, 2009, her headaches worsened. Id. She was diagnosed with migraine. Id.

Her symptoms continued until March. Id. She also developed an inability to maintain balance in

order to walk. She did not have vertigo or nystagmus. Id. Her headaches worsened. Id. She

began various medications, including multivitamins and melatonin. Id. She had lower extremity

weakness and, on June 30, 2009, testing showed she had an elevated ANA. Id. at 1, 2. On

November 11, 2009, she saw Dr. Cornblath at Johns Hopkins, who did not feel that Gardasil

caused her symptoms. Id. at 2. He evaluated her and did not find any objective evidence of

neurological deficits. Id. On October 23, 2009, petitioner had a positive ANA at a titer of

1:1280 and a borderline low hematocrit. Her hexagonal phospholipid was positive. She had a

normal Russell viper venom time. Her anti-cardiolipin antibodies were negative. Her iron

studies, serum immunoglobulin, and thyroid studies were normal. Her 25-hydroxyvitamin D

33

was mildly low at 33.6. Petitioner complained of headaches, bluish discoloration of her toes,

photophobia, and phonophobia. She was wearing sunglasses. Her mother had possible

rheumatoid arthritis although the family is uncertain about this. On review of systems, the

pertinent positives were excessive hair loss and bluish discoloration of the toes. She stated she

felt dizzy upon getting up from a supine position and felt weakness and numbness in her left

lower extremity. She stated her right knee was painful because of over compensation as she used

her right leg more. Id.

On physical examination, Dr. Petri did not find any alopecia (hair loss). Id. at 3.

Petitioner had livedo 23 around both knees and forearms. There was cyanosis 24 in the toes. On

neurological exam, petitioner did not have any objective evidence of sensory or motor deficits.

Her Romberg’s test was negative. Dr. Petri diagnosed petitioner with undifferentiated

connective tissue disease (“UCTD”) based on petitioner’s positive ANA, Raynaud’s disease,

livedo, and lupus anticoagulant. Id. She recommended petitioner take Plaquenil. In answer to

petitioner’s parents’ concern that Gardasil caused petitioner’s headaches, Dr. Petri wrote that

symptom onset was six weeks post-vaccination. (Actually, it was 10 weeks post-vaccination.)

Id. Dr. Petri engaged in a detailed discussion with the family. She said there is a mean of three

to four years between positive serologies and clinical onset of symptoms in systemic lupus

erythematosus (“SLE”). Plaquenil would delay the progression of UCTD to SLE. Ten percent

of UCTD progressed to SLE. Petitioner needed to avoid sunlight, garlic, G-CSF, echinacea,

melatonin, Bactrim, and alfalfa sprouts. Dr. Petri gave petitioner a headache prevention diet and

recommended nortriptyline. Petitioner was advised to take 2.5 mg. of amlodipine for her

Raynaud’s syndrome. If her lupus anticoagulant remained positive, she should consider starting

aspirin. She should stop taking melatonin as this worsened SLE. Dr. Petri recommended

petitioner take a tilt table test to rule out neutrally mediated hypotension. Id. Dr. Petri noted that

she could not connect petitioner’s UCTD to Gardasil. Id.

On December 16, 2009, Dr. Nichter called Dr. Kennette to discuss the apparent lack of

effective treatment offered to petitioner as of that date and what, if anything could be considered

next. Med. recs. Ex. 12, at 57. Dr. Kennette suggested petitioner’s returning to see Dr. Sandler,

the psychiatrist, was in her best interests. Id.

On December 17, 2009, Dr. Kennette called Dr. Sandler who said he was ready to see

petitioner whenever she was ready to return. Id.

Also on December 17, 2009, petitioner underwent a transthoracic echo, which was

abnormal, showing a trace mitral regurgitation, tricuspid regurgitation, and aortic insufficiency. 25

Med. recs. Ex. 13, at 3. She had normal left ventricular function. Id.

23

Livedo is “a discolored spot or patch on the skin.” Dorland’s at 1067.

24

Cyanosis is “a bluish discoloration.” Dorland’s at 452.

25

Mitral regurgitation is “the backflow of blood from the left ventricle into the left atrium, owing to

mitral valve insufficiency; it may be acute or chronic, and is usually due to mitral valve prolapse,

34

On January 6, 2010, petitioner wore a Holter monitor, which showed occasional

tachycardia of 160 beats per minute at 1:34 a.m., dizziness reported with normal sinus rhythm

and a heart rate of 70 beats per minute, and rare PACs. 26 Id. at 4.

On January 14, 2010, petitioner saw Dr. James O’Brien, a cardiologist, for syncope and

palpitations. Id. at 5. He reviewed her January 14, 2010 EKG which showed sinus rhythm with

an incomplete right bundle branch block, 27 as well as the results of her January 6, 2010 Holter

monitor. Id. Dr. O’Brien attributed petitioner’s near syncope to vasovagal 28 intolerance. Id. at

6.

On January 19, 2010, petitioner saw Dr. Nichter. Med. recs. Ex. 18, at 1. The cardiology

department at the Children’s Hospital at Albany Medical Center felt she met the criteria for

POTS. Id.

Also on January 19, 2010, petitioner’s hexagonal phospholipid was now 6.2 which was

borderline since negative was below 6.2 and positive was above 6.2. Med. recs. Ex. 8, at 5. She

again had an abnormal lupus anticoagulant panel. Id. Her ANA was 1:640 with an atypical

discrete speckled pattern. Id. at 17.

On February 11, 2010, petitioner saw Dr. O’Brien for an evaluation of her syncope and

palpitations. Med. recs. Ex. 13, at 8. An EKG done on February 11, 2010 showed sinus rhythm

rheumatic heart disease, or a complication of cardiac dilatation.” Dorland’s at 1621. Tricuspid

regurgitation is “the backflow of blood from the right ventricle into the right atrium, owing to tricuspid

valve insufficiency.” Id. Aortic insufficiency is “defective functioning of the aortic valve, with

incomplete closure resulting in aortic regurgitation.” Id. at 945.

26

PAC stands for “premature atrial complex.” Dorland’s at 1359. Atrial premature complex is “a single

ectopic atrial beat arising prematurely, manifest electrocardiographically as an abnormally shaped

premature P wave, usually with a slightly increased PR interval. It occurs in normal hearts, sometimes

associated with the use of stimulants, but may be associated with structural heart disease.” Id. at 395.

The P wave is “in the electrocardiogram, the initial deflection of the cardiac cycle, representing excitation

of the atria.” Id. at 2077. The PR interval is “the portion of the electrocardiogram between the onset of

the P wave (atrial depolarization) and the onset of the QRS complex (ventricular depolarization), lasting

approximately 0.12 to 0.20 second in the adult. It is the time taken for an impulse to traverse the

atrioventricular node, bundle of His, and bundle branches.” Id. at 951.

27

A bundle branch block is an “interruption of conduction in one of the main bundle branches, left or

right; the sequence of ventricular depolarization is altered since the impulse reaches one ventricle and

then travels to the other.” Dorland’s at 226.

28

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 at 1818.

35

with normal intervals. Id. Dr. O’Brien felt the best diagnosis was vasovagal intolerance. Id. at

9.

On March 1, 2010, Dr. Nichter noted that petitioner’s ANA went from 1:1280 to 1:640.

Med. recs. at Ex. 18.2, at 1. Her cardiolipin was minimally elevated or basically within normal

limits. Id. Her gait had significantly improved and she could almost run. Id. More recently,

petitioner developed POTS. Id. She had a vesicular rash on her skin occasionally and a reddish

hue on her cheeks, but that did not meet the criteria for a butterfly rash of systemic lupus

erythematosus. Id. at 2. Dr. Nichter queried whether there was any relationship between POTS

and rheumatological disorders. Id.

On May 20, 2010, Dr. Nichter noted that petitioner had headache with major visual

complaints and abnormal autonomic function, although other aspects of autonomic dysfunction,

such as sweating, bowel, bladder, and gastric emptying, had been completely normal. Med. recs.

Ex. 18.3, at 2-3. Her tests for Hashimoto’s encephalopathy and thyroid peroxidases were

completely normal. Id. Dr. Nichter stated, “One cannot cogently bring all components to her

history into a single story.” Id. He said autonomic dysfunction was a consideration. Id.

On July 20, 2010, petitioner saw Dr. Jill M. Abelseth, an endocrinologist. Med. recs. Ex.

17, at 1. Petitioner had normal adrenal and thyroid function studies. Id. at 2.

On July 29, 2010, petitioner had the same borderline 6.2 for hexagonal phospholipid as

she had on January 19, 2010. Med. recs. Ex. 8, at 5. Her lupus anticoagulant panel had become

borderline whereas, previously, it was abnormal. Id. Testing for AChReceptor 29 (“AChR”)

(muscle) binding antibody was negative. Id. at 21. Testing for N type calcium channel antibody

was negative. Id. Testing for P/Q type calcium channel antibody was negative. Id. at 22.

Testing for AChR ganglionic neuronal antibody was negative. Id. Testing for neuronal voltage-

gated potassium channel antibody was negative. Id. Petitioner’s ANA was 1:1280 with an

atypical discrete speckled pattern. Id. at 17.

On August 6, 2010, petitioner saw Dr. Kennette for her 16-year, five-month check-up.

Med. recs. Ex. 12, at 60. She had headaches 24/7, which were on a 6/10 scale that day. She had

taken a Caribbean cruise in April and was going to Disney World during the New Year. She had

low blood pressure attacks and fell down. Her blood pressure was very low and her heart rate

dropped usually with body position changes. She was taking Aleve and Tylenol PM. She did

minimal walking of less than one mile when tolerated. Her periods were irregular for four

29

ACh stands for “acetylcholine.” Dorland’s at 14. Acetylcholine is “a reversible acetic ester of choline;

it is a cholinergic agonist and serves as a neurotransmitter at the myoneural junctions of striated muscles,

at autonomic effector cells innervated by parasympathetic nerves, at the preganglionic synapses of the

sympathetic and parasympathetic nervous systems, and at various sites in the central nervous system.” Id.

at 12. “Myoneural” pertains “to both muscle and nerve; said of the nerve terminations in muscles.” Id. at

1224.

36

months, ranging from three to eight weeks. She weighed 120 pounds. Her BMI was 19. She

seemed sullen and upset. Her heart rate was 68-72. She had a one and one-half year history of

daily headaches ranging from 3/10 to “40”/10 (Dr. Kennette used quotation marks), which were

unresponsive to myriad interventions. Petitioner’s previous episodes of abnormal gait were now

resolved. Now she had episodes of syncope secondary to lower blood pressure and abnormal

pulse. Her ANA was between 640 and 1280 for the past year. She had Raynaud’s disease.

Petitioner did not wish to discuss guidance or counseling that day, but desired to keep in regular

contact with Dr. Kennette by telephone for “emotional support” (Dr. Kennette used quotation

marks). Id. at 60-61. The total time Dr. Kennette spent with petitioner and her parents was one

hour and 45 minutes. Id. at 61.

In an addendum to her August 6, 2010 visit notes, Dr. Kennette recorded that petitioner’s

father brought an extensive set of medical records which included reviews of information that

Dr. Kennette had not received, e.g., from Dr. O’Brien, the cardiologist, an update from Dr. Sarah

Elmendorf, 30 an infectious disease expert, and information from an upcoming visit to Johns

Hopkins Hospital. Id. at 62. Dr. Kennette reviewed the various medication trials, e.g., Florinef

(petitioner did not tolerate it), and Midodrine (petitioner did not feel it was helpful). She

reviewed laboratory data not previously provided, e.g., EKG, Holter monitor, echocardiogram,

and basic metabolic profile, all of which were normal. She reviewed Dr. O’Brien’s provisional

diagnoses of tachycardia and dysautonomia. Dr. Kennette had an extensive one-on-one

interview with petitioner alone to update her on her condition and discuss her current status at

home and her impression of how she felt. Plus Dr. Kennette reviewed with petitioner current

strategies for school limitations based on her physical abilities. Id. Dr. Kennette discovered

after reviewing all of the reports given to her that day by petitioner’s family that petitioner had

not received the Western blot examination of blood for Lyme disease or empiric treatment for

Lyme disease. Id. at 63. Dr. Kennette was going to add a request for the Western blot test to be

done on July 29, 2010. After speaking to petitioner’s father, Dr. Kennette wanted to empirically

treat petitioner for Lyme disease with Doxycycline 200 mg. daily for two to four months and

reassess her symptoms. Id.

On August 9, 2010, Dr. Kennette telephoned petitioner’s mother. Id. Petitioner had not

yet started taking Doxycycline because she was “not feeling well enough to eat much” (Dr.

Kennette used quotation marks) over the weekend. Petitioner was going to seek an opinion at

Johns Hopkings with Dr. Rowe, a pediatric diagnostic clinician, and might try Doxycycline at a

lower dose when she and her parents returned, perhaps 300 mg/day instead of 400 mg/day. Id.

30

Petitioner did not file any medical records from Dr. Sarah Elmendorf. Petitioner’s father testified that

he has known Dr. Elmendorf since medical school, they were both on the overgoverning board of the

hospital for well over ten years, they have sat on many committees together, and they live six blocks

apart. Tr. at 168. He used Dr. Elmendorf as a sounding board to discuss petitioner’s condition and

treatment, and any avenues petitioner and her parents could pursue for diagnosis and treatment. Id. at

169.

37

On August 11, 2010, petitioner saw Dr. Peter C. Rowe at Johns Hopkins University for

further evaluation of her orthostatic intolerance, fatigue, and other problems. Med. recs. Ex. 6, at

4. She was quite flexible as a child and could put her leg behind her head, had a positive Gorlin

sign, 31 and could make a clover-like configuration with her tongue. She had a number of

fractures. At age 8, she fell on her wrist and fractured it. She sprained her left ankle soon

afterwards, requiring a cast and then a walking boot. At age 11, she fractured her left fourth

finger when someone stepped on her hand. At age 12, petitioner had a fracture at the epiphysis

of the right ankle while playing soccer and was in a cast and a boot for a total of seven weeks.

She underwent nuclear medicine scanning at that time because of persistent pain and concern

about complex regional pain syndrome. At age 14, she fractured several bones in the left hand

after hyperextending her thumb in volleyball. Also at age 14, she fractured her left fibular in

soccer and refractured this bone when she fell walking up stairs. She had some headaches in

2007 that resolved. Id.

Dr. Rowe noted that petitioner did not have an immediate reaction to either of her two

Gardasil vaccinations, the first on August 26, 2008 and the second on December 3, 2008. Id.

Her main problems began on February 15, 2009, when she suddenly developed a sore throat,

fatigue, and swollen glands that lasted a week, followed within five days by a headache, which

became progressively worse, associated with photophobia, phonophobia, and diminished

appetite. Id. She had not been well since the onset of this illness. By early March 2009,

petitioner was collapsing, weak, unable to walk, and spent much of the day reclining. She did

not walk much until August 2009. Although Dr. Petrie diagnosed petitioner with UCTD and had

recommended Plaquenil, petitioner had not started Plaquenil. Id.

Petitioner had seen cardiologist, Dr. James O’Brien, on December 17, 2009, who felt she

had vasovagal syncope and an associated POTS. Id. at 5. Trials of Florinef and midodrine were

31

The Gorlin sign is “the ability to touch the tip of the nose with the tongue, frequently a sign of Ehlers-

Danlos syndrome.” Dorland’s at 1711. Ehlers-Danlos syndrome is “a group of inherited disorders of the

connective tissue; they were formerly classified into ten types, but more recently only six types are

distinguished, varying widely in severity. The major manifestations include hyperextensible skin and

joints, easy bruisability, friability of tissues with bleeding and poor wound healing, calcified

subcutaneous spheroids, and pseudotumors. The hypermobility type (formerly type III) is autosomal

dominant and most common type; mitral valve prolapse accompanies the skin and joint anomalies. The

classical type (formerly types I and II) has both autosomal dominant and autosomal recessive subtypes; it

includes mitral valve prolapse as well as fibrous growths on pressure areas such as the knees and elbows.

The vascular type (formerly type IV) is autosomal dominant and is characterized by fragile blood vessels

and organs that may rupture, as well as distinctive facial features such as protruding eyes and thin nose

and lips. The kyphoscoliosis type (formerly type VI) is a rare, autosomal recessive type characterized by

kyphoscoliosis and eye fragility accompanying bone and joint anomalies. The arthrochalasis type

(formerly types VIIA and VIIB) is a rare, autosomal dominant type in which joints are particularly loose

and prone to dislocation; patients also suffer from arthritis and bone loss. The dermatosparaxis type

(formerly type VIIC) is an autosomal recessive type characterized by particularly fragile and sagging

skin. Most types are related to defects in procollagen . . . .” Id. at 1828-29.

38

ineffective. Petitioner increased her intake of salt and fluids. Nevertheless, her systolic

pressures have been in the 60-80 range. On electrocardiogram, she had normal left ventricular

function, a normal aortic root of 2.5 cm, and echocardiographic evidence of trace mitral

regurgitation, tricuspid regurgitation, and aortic insufficiency, but no murmur.

Currently, petitioner reported headaches, lightheadedness, syncope, fatigue, cognitive

problems, photophobia, phonophobia, gastrointestinal symptoms, some hair loss, problems

regulating temperature, cold feet and hands, numbness in an ulnar distribution which awakened

her every other night, insomnia, racing of her heart, occasional shortness of breath, acne, and

increased thirst. Petitioner reported a constant headache that never resolved, but also clusters of

more intense worsened headaches. Sometimes, the headaches felt like a vise, exerting pressure

within her head, and stabbing, causing downward pressure on the top of her head. Loud noises

and bright lights aggravated the intensity of her headache, although lately the photophobia had

not been as bad. She slept with earplugs. She often skipped breakfast. She stated she never had

a problem with lightheadedness and syncope until her illness in February 2009. Her legs would

give out in March 2009 and her heart raced. She had a poorly coordinated gait that may have

been related to weakness and deconditioning. Lightheadedness and syncope were more clearly

reported in April or May 2009 whenever she would move from sitting to standing after she had a

month or more of almost total inactivity. Her Holter monitor average heart rate was 76 beats per

minute with a range of 52-160 beats. She had a true loss of consciousness with syncope about 12

times over the course of the illness, but syncope was less frequent in recent months. She still had

some lightheadedness with dimming of her vision when she stood up, but tended to hold on

tightly to something and resolved the lightheadedness fairly promptly. She had a number of

orthostatic intolerance postures, such as sitting with her knees to her chest frequently. Fatigue

occurred daily, although she had occasional spurts of better energy. Activity and sleeping too

much or too little worsened her fatigue. After a syncopal episode, her fatigue was often worse.

It was also worse after shopping. Id. Hot weather also worsened her fatigue. Id. at 6. She could

force herself to attend a special event or have a special day, but then her malaise increased for

one to two days afterward. She had a variable attention span and concentration. Her

understanding tended to flag when she was more tired. However, her grades had been good. She

was still quite sensitive to sounds within her house although her photophobia and phonophobia

were slightly better. Her gastrointestinal symptoms included a sense of tightness in the

epigastric area and a feeling that she could not breathe. This occurred less than five days a week

and lasted a couple of hours when present. She had reflux one to three times a week and early

satiety but no aphthous ulcers. She lost 20 pounds early in her illness, but regained about 10

pounds over the last year. Going off milk for a month did not improve her. She said she had lots

of hair in her brushes and in the drains, but she did not have any complete patches of alopecia on

examination. Petitioner preferred the temperature in her room to be about 67 degrees and often

felt quite hot. Her temperature regulation problems varied substantially. Her parents

occasionally found her lying on the hot driveway in the summer sun with winter clothing on,

trying to get warm. Her Lyme test, Ehrlichia test, and Babesia test were negative. The family

history is notable for allergies in her father and a paternal aunt. Id.

39

On physical examination, Dr. Rowe detected petitioner had blue sclerae, 32 a positive

Gorlin sign, and subluxation/clicking of the temporomandibular joint (“TMJ”) with mouth

opening. She could place her palms flat on the floor. Since her Beighton score was only 1, she

did not meet the full criteria for joint hypermobility. She had diffuse acrocyanosis. 33 He did not

see evidence of Raynaud’s phenomenon during this visit. Romberg sign was negative. She was

a bit unsteady with tandem gait. She had hypermobility on straight leg raise, with stretch elicited

at 70 degrees bilaterally, with end-range 120 degrees on the right and 110 degrees on the left, far

greater than normal. Dr. Rowe performed a standing test to evaluate petitioner’s orthostatic

tolerance. Her lowest resting heart rate supine was 47 beats per minute with a blood pressure of

103/56. On standing, she had an immediate increase to 82 beats per minute and continued to

increase gradually to a maximum of 98 beats per minute after nine minutes. Id. Petitioner had

an initial increase in her lightheadedness with standing that improved after about a minute, but

her fatigue level and lightheadedness increased modestly over the 10 minutes of standing. Id. at

7.

Dr. Rowe’s assessment was that petitioner had a post-viral fatigue illness that now met

the criteria for chronic fatigue syndrome since she had fatigue for more than six months, post-

exertional worsening of malaise, new-onset headaches, myalgias, cognitive problems, and

unrefreshing sleep. Id. at 7. Petitioner had resting hypotension without formal tilt testing and

had recurrent syncope that was consistent with neutrally-mediated hypotension. Her standing

test that day was entirely consistent with POTS. She had a 51-beat per minute increase in heart

rate within 10 minutes of standing, essentially doubling her heart rate associated with some

modest increases in fatigue and lightheadedness. Her heart rate changed despite taking high salt

and fluid. Petitioner had a lot in the way of allergies or asthma, some mild acne, and

deconditioning. She had a number of phenotypic features usually seen in association with

connective tissue laxity, but did not meet the full Beighton score criteria for hypermobility, but

had a number of other features, such as blue sclerae, the Gorlin sign, and extreme hypermobility

at the hips. Dr. Rowe said, “I suspect the connective tissue phenotype is allowing excessive

vascular compliance in the dependent circulation, and is a factor contributing to her orthostatic

intolerance, along with the deconditioning, which in turn causes a loss of plasma volume.” Id.

He suggested petitioner increase her exercise and improve her conditioning status with physical

therapy. Id. For the orthostatic intolerance, Dr. Rowe suggested she raise the head of her bed

and wear compression garments. She could use postural counter-maneuvers such as clenching

32

Sclera is “the tough white outer coat of the eyeball.” Dorland’s at 1678. Blue sclerae is “a prominent

feature of osteogenesis imperfecta, and is seen in certain other abnormalities.” Id. at 1679. Osteogenesis

imperfecta is “a group of inherited connective tissue disorders characterized by brittle, easily fractured

bones and sometimes other manifestations, including blue sclerae, wormian bones, shortened limbs and

limb deformities, fragile skin, muscle weakness, lax joints, bleeding and easy bruising, hearing loss,

dyspnea, and dentinogenesis imperfecta.” Id. at 1346.

33

Acrocyanosis is “symmetrical cyanosis of the extremities, with persistent, uneven blue or red

discoloration of the skin of the digits, wrists, and ankles accompanied by profuse sweating and coldness

of the digits. Called also Raynaud sign.” Dorland’s at 19.

40

her fists when she began to stand or when she felt lightheaded. He also suggested petitioner

receive two-liter infusions of normal saline over one to two hours to modulate autonomic tone.

Id.

On November 2, 2010, petitioner returned to Dr. Rowe much improved after adopting his

suggestions, such as raising the head of her bed, increasing her salt intake, and using postural

maneuvers. Id. at 9. Her school grades were in the 90s and she was taking up the flute and the

drama club. Id.

On January 23, 2011, petitioner saw Dr. Uhl, the orthopedist, with an injured right knee

while climbing on a snow bank. Med. recs. Ex. 14, at 28. Dr. Uhl suspected medial collateral

ligament injury, but he could not explain her complaint of some numbness. He noted that “in the

past the patient has had altered sensations and may be predisposed to RSD [reflex sympathetic

dystrophy also known as complex regional pain syndrome 34].” Id. He also noted that petitioner

had a prolonged period of thumb pain “with no specific explanation.” Id.

On February 11, 2011, petitioner and her parents saw Dr. Nichter. Med. recs. Ex. 18.4, at

1 . Since her last visit, petitioner had made significant progress. Id. Her gait was basically

normal. Id. Her vertigo was much improved. Id. She continued to have headaches. Id. She

still had fatigue and some elements of POTS. Id. Fluids and salt had been helpful. Id. She did

quite well academically, having an over 90 percent average. Id.

On September 9, 2011, petitioner saw Dr. Kennette, complaining of a sore throat for three

days. Med. recs. Ex. 12, at 65. She had a very busy summer and felt good. She was alert,

active, and chatty. She was not wearing sunglasses. Dr. Kennette diagnosed petitioner with

pharyngitis and tonsillitis. She prescribed penicillin as a “rescue” prescription, but on September

12, 2011, petitioner’s throat culture was negative. Id.

On September 12, 2011, petitioner’s rheumatoid factor was 22, which is higher than

normal, which is below 20. Med. recs. Ex. 8, at 17. Her ANA was 1:640 in an atypical discrete

speckled pattern. The normal result should be below 1:320. Id. Her EBV IgG was positive at

1:10 and weakly positive at 1:640. Id. at 16. Her EBV IgM was also positive. Id.

On September 16, 2011, petitioner saw Dr. Kennette for her 17-year, seven-month visit.

Med. recs. Ex. 12, at 66. Her monospot test 35 was positive and she had a slight elevation in her

white blood cells. Petitioner was in school all day. She had been on penicillin for seven days.

She was occasionally on a treadmill. She had normal gait and strength. Petitioner was much

improved concerning non-specific chronic headaches, decreased blood pressure with irregular

Dorland’s at 585, 1826.

34

The mononucleosis spot test or monospot test is “a type of heterophile antibody test for infectious

35

mononucleosis. . . .” Dorland’s at 1894.

41

heart rate, and fatigue. She had a recent diagnosis of mono. She had acne, for which Dr.

Kennette prescribed Clindamycin. 36

On September 19, 2011, Dr. Kennette wrote a letter to petitioner’s high school, stating

petitioner was clearly much improved from the prior year. Id. at 67. However, at times,

petitioner might need a modified school environment and/or time frames for assignments and

tests. She frequently had headaches, but they were not usually as severe as the ones she had in

the past. But she might need access to large print books or books on tape and must be allowed

access to frequent water breaks throughout the day. Id.

On October 12, 2012, petitioner saw Dr. David Palat, a pulmonologist, for bronchitis,

chest pain, and cough. Med. recs. Ex. 21, at 1. In his review of systems, Dr. Palat notes

petitioner had no vision problems. Id. He also notes petitioner did not have palpitations, her

heart rate was not fast, and her hands and feet were not cold. Id. at 2. He notes that petitioner

did not feel weak. She did not have finger pain or blanching with cold. She did not have

arthritis. She did not have localized joint pain or localized joint stiffness. She did not have

dizziness, sleep disturbances, or insomnia. Id. Dr. Palat measured petitioner’s blood pressure. It

was 112/80. Her pulse rate was 84 beats per minute. Id. She weighed 133 pounds and was five

feet 7 inches tall. Id. Petitioner’s gait and stance were normal. Id. at 3. Dr. Palat’s assessment

was bronchitis. Id.

On November 21, 2012, petitioner and her mother saw Dr. Jennifer Lindstrom, a

pediatrician and internal medicine specialist, for the first time (to replace Dr. Kennette). Med.

recs. Ex. 552, at 23. Petitioner’s mother believed that Gardasil caused all her medical problems,

including gait instability, severe headaches, an elevated ANA, and orthostatic hypotension. Id.

Petitioner had been on multiple headache medications without success. Hypnosis failed to help

her. Petitioner refused to follow up with neurology again. Petitioner saw a rheumatologist about

her elevated ANA and she diagnosed petitioner with undifferentiated connective tissue disease.

Petitioner had not followed up on this. Dr. O’Brien recommended petitioner take midodrine and

Florinef for her orthostatic hypotension, but petitioner was no longer taking them. She instead

tried to follow a high sodium diet. Id. Petitioner was drinking four to eight alcoholic drinks on

the weekend, which qualified as binge drinking. Id. at 24. Petitioner’s headaches failed to

respond to Topamax, Imitrex, Lortab, Cymbalta, Toradol, Compazine, and Benadryl. Id. at 25.

Dr. Lindstrom counseled petitioner that four to eight drinks on the weekend qualified as binge

drinking. Id. at 24. Petitioner said she would cut back. Id. at 25.

On March 7, 2013, petitioner with her parents saw Dr. Nichter, complaining of a

significant exacerbation of her migraines. Med. recs. Ex. 552, at 20. The prior week she had a

lot of pain and told her father to cut her head off. The headaches were frontal, temporal, and

sometimes extending to the back. They could be 10/10 and petitioner was crying at times. She

had photophobia. Id. Petitioner had academic stresses and social stresses with her roommate at

36

Clindamycin is an antibiotic “effective primarily against gram-positive bacteria.” Dorland’s at 372.

42

college. Id. Lortab, Imitrex, Ativan, and Reglan did not improve her headaches, with the latter

two causing negative adverse reactions. Benadryl had given her “a buzz” and was not sedative.

Id. at 21. Petitioner’s physical examination was normal. Petitioner had been in good health.

She did not have joint swelling or decline in vision or hearing. Petitioner was “alert and

interactive with a wonderful fund of knowledge. She was quite articulate in explaining why she

understands playing the role of another person i[s] understanding herself.” Id. Dr. Nichter’s

assessment was that the cause of petitioner’s migraines was most likely multifactorial in that

stressors had accumulated and exacerbated her migraines. Dr. Nichter discussed with petitioner

and her parents going to the emergency room to have a combination of Toradol, Benadryl, and

Reglan administered, but they decided not to do that. Id. Dr. Nichter provided the name and

telephone number of an acupuncturist. Id.

On March 28, 2013, Dr. Nichter wrote a letter to the campus center of the college

petitioner attended, requesting a single dormitory room for her because her living arrangement

with a roommate exacerbated petitioner’s headaches. Sleeping continued to be a challenging

problem for her. Id. at 19.

On January 23, 2014, petitioner saw Dr. Laura El Hage for her annual examination. Id. at

15. Petitioner had chronic daily headache but they did not worsen when she began oral

contraceptives. She did not have any abnormal neurologic symptoms such as numbness or

weakness during her headaches. Id. Petitioner occasionally used EtOH (ethyl alcohol). 37

Petitioner said she did not binge. She denied any other illicit drug use. She said she woke

frequently during the night, 15 times a night and could wake up for an hour at a time. She did

not have difficulty walking. All other systems reviewed were negative. Her strength was intact

and equal in all four extremities. Sensation was intact throughout. Id. Dr. El Hage diagnosed

petitioner with chronic fatigue syndrome and chronic migraine without aura. Id. at 17.

On December 12, 2014, petitioner and her mother again saw Dr. Lindstrom. Id. at 13.

Petitioner had general malaise in terms of decreased sleep, daytime fatigue, stressful dreams,

inability to focus, and feeling restless. Id. She had some difficulty with her first semester at

college and took an incomplete in one course. Petitioner had been crying more. She was

interested in going back to see Dr. Nichter whom she had not seen in two years. Id. On physical

examination, petitioner was at times almost tearful. Id. Dr. Lindstrom diagnosed petitioner with

multiple symptoms of mood disorder, not otherwise specified, with some feelings of reliving

stressful dreams, some crying, decreased sleep, and some symptoms of inattention. Dr.

Lindstrom believed petitioner needed a neuropsychiatric evaluation to assess her for inattentive

disorders, post-traumatic stress disorder, and stress reactions. Dr. Lindstrom thought petitioner

37

Ethyl alcohol is ethanol. Dorland’s at 45. Ethanol is “a primary alcohol existing as a transparent,

colorless, volatile, flammable liquid, miscible with water, methanol, ether, chloroform and acetone; it is

formed by microbial fermentation of carbohydrates or by synthesis from ethylene. Excessive ingestion

results in acute intoxication, with psychological, gastrointestinal, neurological, and motor abnormalities. .

. .” Id. at 650.

43

would benefit from counseling. As for orthostatic hypertension, petitioner’s blood pressure was

stable that day. Petitioner had been using table salt. She had chronic migraines headaches for

which she would see Dr. Nichter. Id. at 14.

On December 31, 2014, petitioner and her parents saw Dr. Nichter. Id. at 9. Stress was

an issue for petitioner. Over the last several weeks, she had such difficulty with stress that she

would hyperventilate sometimes and have a 15- and 20-minute period where she was not in

control of herself. This exacerbated over the last few weeks. She had a significant sleep

dysfunction. Before trying to sleep, she would take Tylenol PM, which contains Benadryl, and

then perhaps a glass of wine a few times a week. Id. She had daily headaches. She did not take

any medication for POTS but used various salts. Id. On physical examination, she had normal

gait. Id. at 10. There was nothing to suggest seizures or a neurodegenerative process. She did

not have an upper or lower motor neuron disease. Dr. Nichter found her to be “a bright young

lady who may have put a number of stressors and possibly too many on her plate.” Id. She was

“alert, fluent. She had a wonderful fund of knowledge.” Id. As for petitioner’s sleeping

difficulties, Dr. Nichter stated it “would be helpful to decrease and stop the alcohol. It would be

helpful to stop the Benadryl and Tylenol PM.” Id. Dr. Nichter’s plan was for the family to

consider counseling vs. psychiatry. The family was fine with the plan. Id.

On March 2, 2015, petitioner saw Dr. El Hage for her annual exam. Id. at 6. Her mother

accompanied her. She had chronic daily migraine. Petitioner was using a lot of Aleve (three to

six pills per day at 220 mg. each). She did not have any abnormal neurologic symptoms during

her headaches. As for her POTS, she had frequent pre-syncopal events, but no true syncopal

episodes. She could exercise without difficulty. She denied chest pain or palpitations during

exercise. Id. She drank 16 ounces of coffee with two shots of espresso daily. Id. at 7. She lifted

weights and used the elliptical machine. Her major was theater and political science. She

wanted to do theater professionally. She woke 15 times per night and could wake for an hour at

a time. She felt tired in the morning. All other systems were negative. Id. Overall, petitioner

was doing well except for her chronic migraines. Id. at 8. Dr. El Hage discussed medication

overuse with petitioner and her mother. She recommended that petitioner avoid NSAIDs

(Motrin, Advil, Aleve) and take Tylenol as needed for headache. She should avoid Advil

because it can cause gastrointestinal side effects and renal issues long term. If petitioner

improved, Dr. El Hage would discuss with her that Tylenol can also cause overuse headache and

petitioner should be conscientious with its use long term as well. Id.

On March 16, 2015, petitioner saw Dr. Nichter on an urgent basis in light of increased

seizure. Id. at 4. Petitioner came with her parents. Approximately two to three weeks earlier,

petitioner had increasing headaches. At one point, she came home from college and assumed a

fetal position, crying constantly. She tried oxycodone and slept a while. The headache tended to

be diffuse and pounding with photophobia and phonophobia. Petitioner switched from Aleve to

Tylenol. Yet, on some days, even four days, she took nothing, but on other days, she took five to

seven in a day. Probably, every week, she took at least four pills a week. Medications she tried

but which failed included Topamax, Benzodiazepine, Reglan, and Maxalt. Two precipitating

44

factors contributed to her headaches: (1) academic stressors, and (2) sleep dysfunction. Id.

Petitioner would pull an all-nighter and then have significant headaches. Yet she had a double

major and a minor and was a high achieving student. She did not have any major deficit in terms

of gait, vision, or hearing. She did not have swallowing difficulties. She did not have weakness

or ataxia. She did not have bowel or bladder problems. She used salts and fluids to help her

POTS and they worked reasonably well. Review of systems was benign. Id. On neurological

examination, she was normal. Id. at 5. Dr. Nichter wrote: “She is a bright young lady,

introspective and has a wonderful fund of knowledge.” Id. Dr. Nichter diagnosed her with a

history of migraines and a multifactorial stressful life. She had tried acupuncture without

success. The drug Restoril did not improve her sleep. Dr. Nichter prescribed Elavil. 38 He

advised her to work on her sleep hygiene. Although Dr. Argoff recommended Botox, petitioner

said she did not want it. Dr. Nichter also recommended she increase her dosage of melatonin.

Id.

On May 7, 2015, petitioner saw PA Sujata Kane, complaining of low back pain and a

rash. Id. at 1. Petitioner said she had low back pain for the prior four to five days. She had been

lifting a free weight of approximately 50 pounds, which was heavier than what she usually lifted

in the gym. She knew her posture was not the best when she did this. She also had a rash on her

right lower extremity for two days. Petitioner said she has pre-lupus and a connective tissue

disorder with a history of significantly elevated ANA. She told PA Kane she had never been to a

rheumatologist. She said she was allergic to Ambien, Reglan, Toradol, Compazine, and

Depakote. Id. She said she stopped taking Elavil because she thought it did not work. PA Kane

diagnosed petitioner with a back muscle spasm. Id. at 2.

Expert Reports

On June 24, 2013, petitioner filed the expert report of Dr. Yehuda Shoenfeld, an

immunologist, as Exhibit 24. He worded his report as answers to seven questions the

undersigned raised in the undersigned’s Order to Show Cause, dated November 13, 2012.

In answer to question 1, that petitioner had the same symptoms prior to receiving

Gardasil as she had after Gardasil, Dr. Shoenfeld responded that she had recovered from these

symptoms in 2007 and they did not cause long-term disability. Ex. 24, at 1. 39 Moreover, she

had new symptoms after Gardasil, including recurrent syncope, fatigue, neck pain, joint pains,

numb legs, cognitive disturbances, blurred vision, unrefreshing sleep, tachycardia, dyspnea,

impaired thermoregulation, cold extremities (subsequently diagnosed as Raynaud’s disease), toe

discoloration, excessive hair loss, gastrointestinal disturbances, lessened appetite, altered sense

of taste, and significant weight loss. Id. She also had positive findings for ANA, anti-

phospholipid antibodies, and lupus anticoagulant. Id. Dr. Shoenfeld stated none of these

38

Elavil is an antidepressant also used for chronic pain. Dorland’s at 598, 63

39

Dr. Shoenfeld’s expert report is not paginated. The undersigned is using the page numbers on the top

right of the page that are part of the CM-ECF system.

45

manifestations was present prior to her February 2009 illness. Id. To Dr. Shoenfeld, that meant

Gardasil triggered them. Id. He did not mention, much less discuss, petitioner’s prior viral

illness on February 15, 2009.

In answer to question 2, that the 2007 symptoms dissipated and then returned after the

February 15, 2009 viral illness, Dr. Shoenfeld responded that petitioner’s 2009 viral illness was

only presumed because she had flu-like symptoms such as sore throat and enlarged nodes, but

not actually verified by laboratory testing. Id. Tests for bacterial infection were negative. Id.

Dr. Shoenfeld doubted that petitioner’s flu-like symptoms in 2009 were viral-based because they

are well-recognized symptoms for chronic fatigue syndrome (“CFS”), otherwise known as

myalgic encephalomyelitis. Id. Dr. Shoenfeld believed petitioner satisfied the criteria for CFS

because she had persistent fatigue for over six months, headaches, unrefreshing sleep, and

cognitive disturbances. Id. He then related that flu-like symptoms and CFS are associated with

certain vaccines, particularly vaccines containing aluminum and other adjuvants. Id. He stated

that because vaccines induce an immune response similar to infections, they may also trigger

autoimmune and immune-mediated inflammatory diseases, just as infections do. Id. Unlike

infections, however, vaccines frequently contain adjuvants, and Dr. Shoenfeld stated these

adjuvants enhance immune stimulation above the levels of natural infections. Id. To Dr.

Shoenfeld, this enhancement suggested “vaccines may provoke more exaggerated, anarchic

immune responses than infections.” Id. at 2. He found his observation particularly relevant

because vaccines, including Gardasil, typically are administered repeatedly over relatively short

periods of time, i.e., weeks or months. Id. Dr. Shoenfeld continued that vaccines have been

reported to precede CFS after exposure to multiple vaccinations and/or as an adverse response to

a vaccine adjuvant. Id. He stated that, since petitioner’s symptoms began after her second

Gardasil, “it is probable that her illness was triggered by an exaggerated pathological vaccine-

related autoimmune response.” Id. Dr. Shoenfeld mentioned numerous VAERS reports of

similar adverse manifestations, i.e., headaches, myalgia, fatigue, weakness, dizziness, flu-like

symptoms, autoimmune disorders, with comparable symptom onset, i.e., two to four months,

following receipt of Gardasil booster shots. Id.

In answer to question 3, that all of petitioner’s treating doctors noted the significance of

petitioner’s February 15, 2009 viral illness, Dr. Shoenfeld responded that these doctors only

presumed a virus was the cause based on her symptom presentation and not on any concrete

laboratory findings. Id. But, because flu-like symptoms are recognized as within the CFS

diagnosis, and CFS is “solidly linked” to vaccines, especially those containing aluminum

adjuvant, including Gardasil, he believed petitioner’s flu-like symptoms were due to her CFS and

not to a viral illness. Id. Dr. Shoenfeld also noted that VAERS reports describe flu-like illnesses

and thus are “possible adverse reactions to vaccines.” Id.

In answer to question 4, that there was a two-month interval between petitioner’s second

Gardasil and the onset of her renewed symptoms, Dr. Shoenfeld responded that a two-month

onset is not unusual for vaccine-related cases and has been previously reported after Gardasil.

Id. He noted that this is shown in supplementary Table 1, but did not provide this table with his

46

report. Id. Dr. Shoenfeld then cited to a medical case report of a teenage girl who died

unexpectedly six months after her third Gardasil booster. Id. In the autopsy blood and splenic

tissues HPV-16 L1 gene DNA fragments corresponding to 16 separate Gardasil vials from

different vaccine lots, suspected of being contaminants, were found, suggesting Gardasil caused

her death. Id. at 2-3. These particles were protected from degradation because they were bound

to particulate aluminum adjuvant used in the vaccine formulation. Id. at 3. In another case

report, Dr. Shoenfeld said there were three cases of systemic lupus erythematosus, including

exacerbation of pre-existing lupus, after Gardasil vaccination. Id. Symptom onset was between

two to four months post-vaccination. Id. Dr. Shoenfeld’s search of VAERS reports of those

complaining of flu-like symptoms, chronic fatigue, myalgia, headaches, weakness, dizziness,

joint pains, weight loss, photophobia, and lupus occurred mostly two to four months after

Gardasil. Id. He attributed flu-like symptoms and chronic fatigue to autoimmune illness

following Gardasil acting as the trigger. Id. Dr. Shoenfeld thought that treating doctors do not

attribute these events to the vaccine and frequently misdiagnose them as due to viral or microbial

illness despite lack of corroborative serological evidence. Id.

In answer to question 5, asking how Gardasil significantly aggravated petitioner’s pre-

existing symptoms, Dr. Shoenfeld responded that individual susceptibility factors play an

important role in determining the severity of adverse reactions. Id. Those risk factors include a

previous history of relevant symptoms and a family history of Raynaud’s disease. Id. These

may have made petitioner more susceptible to having a serious adverse reaction after Gardasil.

Id. Referencing a case study, Dr. Shoenfeld said that two out of three lupus cases fitting the

criteria for ASIA following Gardasil were exacerbations of pre-existing conditions. Id. He

noted that 21 percent of hepatitis B vaccine ASIA cases had either a personal or family history of

autoimmune diseases, referencing another article. Id. Since the estimated occurrence of

autoimmunity in the general population is from 5-8 percent, Dr. Shoenfeld suggested that those

with susceptibility are more likely to suffer disease exacerbation after vaccination. Id.

In answer to question 6, asking how the February 15, 2009 viral syndrome is not itself the

trigger of petitioner’s post-viral fatigue syndrome, Dr. Shoenfeld responded that his answers to

questions 2-4 respond to that. Id. at 4. He also stated that based on petitioner’s clinical

presentation, her flu-like symptoms were most likely an adverse reaction to Gardasil. Id.

In answer to question 7, asking why the advice of one of petitioner’s t

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