# Miller v. Secretary of Health and Human Services

> United States Court of Federal Claims · February 9, 2017

URL: https://www.frixlaw.com/law-library/cases/4124743

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** February 9, 2017
- **Precedential status:** Published
- **Opinion:** Opinion
- **Judges:** Laura D Millman
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/4124743

## Opinion text

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 ov

[Text truncated at 120,000 characters. The full text is on the page linked above.]

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/4124743. Public record. Not legal advice.