Reddy v. Secretary of Health and Human Services ( 2015 )

IN THE UNITED STATES COURT OF FEDERAL CLAIMS
OFFICE OF SPECIAL MASTERS
No. 13-208V
Filed: August 26, 2015
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HOWARD REDDY and HANAN TARABAY, *
as parents and natural guardians of *
A.H.R., a minor *
Petitioners, * Fact Ruling; Statute of
v. * Limitations; Onset;
* Autism; Encephalopathy;
SECRETARY OF HEALTH * Developmental Delay;
AND HUMAN SERVICES, * Significant Aggravation.
Respondent. *
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Marcus J. Michles, Michles & Booth P.A., Pensacola, FL, for petitioners.
Heather L. Pearlman, U.S. Department of Justice, Washington, DC, for respondent.
DECISION DISMISSING THE PETITION AS UNTIMELY FILED1
Vowell, Chief Special Master:
On March 22, 2013, Howard Reddy and Hanan Tarabay [“Mr. Reddy,” “Ms.
Tarabay,” or “petitioners”] filed a petition for compensation on behalf of their minor child,
A.H.R., under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-
10, et seq.2 [the “Vaccine Act” or “Program”]. The petition alleged that the diphtheria,
tetanus, and acellular pertussis ["DTaP"], haemophilus-influenzae type b ["Hib"],
influenza, and varicella vaccinations A.H.R. received on November 3, 2009, caused
A.H.R. to suffer from encephalopathy and developmental delays. Petition at 1.
After conducting a fact hearing to ascertain the precise nature of A.H.R.’s
symptoms and when they first occurred, I find that A.H.R. first displayed symptoms of
1Because this unpublished ruling contains a reasoned explanation for the action in this case, it will be
posted on the United States Court of Federal Claims' website, in accordance with the E-Government Act
of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). In accordance with Vaccine Rule
18(b), petitioners have 14 days to identify and move to delete medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified
material fits within this definition, I will delete such material from public access.
2National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for
ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
developmental delay more than 36 months prior to the filing of this petition. This
developmental delay was the first symptom of his autism spectrum disorder [“ASD”].
Although petitioners now claim that the ASD diagnosis is the result of an underlying
mitochondrial disorder which first manifested as a developmental regression on March
23, 2010,3 what led to the ASD diagnosis is not material to the issue of timing. The first
symptom of A.H.R.’s developmental delay and encephalopathy (the conditions listed in
the petition for which compensation was requested) occurred more than 36 months
before the petition was filed. See § 300aa-16(a)(2). Accordingly, the petition is
dismissed as untimely filed.
I. Procedural History.
Shortly after filing the petition, petitioners filed A.H.R.’s medical records (Pet.
Exs. 1-8, 11-14), their affidavits (Pet. Exs. 9, 10, 19), and affidavits from two treating
physicians, pediatrician Dr. Randall Reese (Pet. Ex. 15), and geneticist Dr. Dmitriy
Niyazov (Pet. Ex. 16).
This case was reassigned to me on June 11, 2013. After petitioners filed some
additional medical records, respondent moved to dismiss this case as untimely filed.
Rule 4(c) Report and Motion to Dismiss [“Mot. to Dismiss”], filed Oct 31, 2013. An
expert report from Dr. (Ph.D.) Judith Miller accompanied the motion. After filings of
additional affidavits, petitioners filed a response to the Mot. to Dismiss, which denied
that A.H.R. exhibited any symptoms of ASD prior to March 23, 2010. Petitioners’
Response [“Pet. Resp.”] at 1, filed February 19, 2014. Additional evidence from both
parties was filed between February and July 2014, including two affidavits from pediatric
neurologist Dr. Weldon Mauney (Pet. Exs. 22 and 25), and supplemental affidavits from
Dr. Reese (Pet. Ex. 21), Dr. Niyazov (Pet. Exs. 24 and 26) and petitioners (Pet. Ex.
23).4
During a status conference on July 23, 2014, petitioners requested that I conduct
an onset hearing to resolve the controverted factual issues in this case in order to
resolve the motion to dismiss. That hearing was conducted in Pensacola, FL, on
November 20-21, 2014.
Based on the record as a whole, I conclude that this case was untimely filed.
The reasons for my conclusion are set forth in more detail below but, in summary, the
contemporaneous records establish that A.H.R. had speech delay, a symptom of ASD,
prior to administration of the allegedly causal vaccinations. This speech delay and
behaviors symptomatic of ASD (problems in cognition, self-help, socialization, and play
3 This date is 36 months prior to the filing of this petition.
4The supplemental affidavit of Dr. Reese (Pet. Ex. 21), affidavit of Dr. Mauney (Pet. Ex. 22) and the joint
supplemental affidavit of petitioners (Pet. Ex. 23) are each Bates stamped “Petitioners’ Exhibit 21” on the
bottom right corner of each page, just above the consecutive page numbers. However, the Notice of
Filing accompanying these three affidavits (ECF 29, filed Feb. 19, 2014), properly listed the affidavits as
separate exhibits 21-23. Throughout the decision, I refer to the affidavits by the separate exhibit numbers
assigned by counsel at the time the Notice of Filing was generated.
2
skills) were documented in A.H.R.’s medical records as occurring more than 36 months
before the petition was filed. His parents expressed concerns to his pediatrician that he
might have ASD more than 36 months before the petition was filed. Although
something occurred on March 23, 2010 that caused Dr. Reese, A.H.R.’s primary
pediatrician, to refer A.H.R. to a neurologist on March 25, 2010, I find that the behaviors
A.H.R. displayed on March 23-24, 2010 were symptoms of the ASD petitioners already
suspected that A.H.R. had, even though his formal diagnosis was not made until
months later. Doctor Mauney’s opinion (Pet. Ex. 22 at 106-07) about A.H.R.’s condition
before he began treating him in April 2010 is both speculative and inaccurate because
A.H.R.’s missing speech milestone was not the only evidence of his ASD prior to March
23, 2010.5 As Dr. Dmitriy Niyazov, the geneticist who subsequently diagnosed A.H.R.
with a mitochondrial disorder, testified (see Transcript [“Tr.”] at 261-62), the ASD
diagnosis was one of the clinical symptoms he relied upon in making the mitochondrial
disorder diagnosis. See also Pet. Ex. 13, p. 292 (letter from Dr. Niyazov stating that the
mitochondrial disease diagnosis “explains his developmental delays and autism”).
Thus, the first symptom of ASD would have been a symptom of the purported
mitochondrial disorder as well.
II. Summary of Relevant Medical Records.
A. Birth and Early Health and Development.
A.H.R. was born in early August 2008. Pet. Ex. 1. His Apgar scores were 8 and
9, reflecting that he was a healthy newborn.6 Pet. Ex. 3 at 23. A.H.R.’s growth and
development were essentially normal throughout his first year of life. See generally,
Pet. Ex. 4, pp. 42, 53-54, 58-61. Although he had some minor childhood illnesses,
including otitis media, upper respiratory infections, rash, and fever, A.H.R. had no
serious illnesses or hospitalizations. Id. He received the usual childhood vaccinations
during the first year of his life.7 He achieved developmental milestones on time. Pet.
Exs. 3, p. 26; 5, pp. 195-96.
5 The affidavit reflects that Dr. Mauney reviewed the records of Drs. Reese and Niyazov, but does not
specifically mention the February 2010 well-child visit at which Dr. Reese noted that A.H.R. missed
several milestones other than vocabulary. The speech pathology and early intervention records were not
listed as records he reviewed. Pet. Ex. 22 at 106. Thus, while I considered Dr. Mauney’s affidavit, I did
not give it much weight. I did consider carefully his medical records, including the histories therein.
6 The Apgar score is a numerical assessment of a newborn’s condition (with lower numbers indicating
problems), usually taken at one minute and five minutes after birth. The score is derived from the infant’s
heart rate, respiration, muscle tone, reflex irritability, and color, with from zero to two points awarded in
each of the five categories. See DORLAND’S ILLUSTRATED MEDICAL DICTIONARY (32nd ed. 2012)
[“DORLAND’S”], at 1682; NELSON TEXTBOOK OF PEDIATRICS (19th ed. 2011) [“NELSON’S ”] at 536-37.
7 Before his first birthday, A.H.R. received three doses each of hepatitis B, rotavirus, Prevnar, and
Pentacel vaccines, as well as an influenza vaccine. Pentacel is the trade name for a combined DTaP,
inactivated polio [“IPV”], and Hib vaccine. Shortly after his first birthday, A.H.R. received initial doses of
the hepatitis A and measles, mumps, and rubella vaccines, and his fourth dose of the Prevnar vaccine.
Pet. Ex. 5, pp. 195-96.
3
At A.H.R.’s 12 month well-child visit, Dr. Reese found A.H.R.’s growth and
development normal. According to the record from this visit, A.H.R. was able to say
“mama” or “dada” and one to three words, “[p]oints to desired objects”, and
“[c]omprehends speech.” Pet. Ex. 4, p. 62.
B. Allegedly Causal Vaccinations and Early Indications of Developmental Delay.
At A.H.R.’s 15 month well-child visit on November 3, 2009, he met nearly all of
the expected developmental milestones. However, he did not use five to ten words.
Pet. Ex. 4, p. 65. Based on this apparent speech delay, Dr. Reese referred A.H.R. to
speech therapy. Id., p. 67. In an open diagnoses list found in Dr. Reese’s records,
speech delay is included, with an onset date of November 3, 2009. Id., p. 99.
At this visit, A.H.R. received the allegedly-causal DTaP, Hib, influenza, and
varicella vaccinations. Id., p. 67; Pet. Ex. 5, pp. 195-96. Two weeks later, on
November 17, 2009, A.H.R. received an H1N1 influenza vaccination.8 Pet. Ex. 4, p. 69.
He was referred to an audiologist during this visit. Id.
C. Evaluations for Developmental Delay
A.H.R. visited the Andrews Institute of Rehabilitation on November 18, 2009,
where he was evaluated by speech therapist Kyle C. Lakas, CCC-SLP. Pet. Ex. 6, p.
197. Ms. Lakas recommended an audiology evaluation. She also indicated that A.H.R.
should return in two to two and one half months if he failed to develop additional words
and sounds. Id. The audiologist who conducted A.H.R.’s audiology evaluation found
his hearing within normal limits for speech in at least the better ear. See Pet. Ex. 7, pp.
199-201. However, she recommended a re-evaluation in six months “to monitor hearing
sensitivity and in an attempt to obtain a more complete audiogram.” Id., p. 199.
The first documentation of parental concern regarding A.H.R.’s speech was in
the December 16, 2009 telephone record from Dr. Reese’s practice. Pet. Ex. 28, p.
327. The notation states that “dad would like to speak with you. [Patient] doesn’t speak,
mom is concerned that [patient] may be autistic.” Id. Their disquiet was consistent with
A.H.R.’s referral to speech therapy for a speech delay diagnosis on January 25, 2010
and Dr. Reese’s diagnosis of a speech delay and additional referral to speech therapy
on February 1, 2010. See Pet. Ex. 4, pp. 72-73, 188-89.
During A.H.R.’s 18 month well-child exam on February 1, 2010, Dr. Reese noted
several developmental problems, including A.H.R.’s inability to say six words, combine
words, or name body parts. Pet. Ex. 4, p. 72; Tr. at 34. Once again, Dr. Reese
diagnosed A.H.R. with a speech delay and recommended speech therapy. Id., p. 73.
8In 2009, the H1N1 influenza vaccine was administered separately from the trivalent seasonal influenza
vaccine and was not a vaccine included on the Vaccine Injury Table. Thus, petitioners have made no
causation claim regarding this vaccination.
4
On February 3, 2010, Ms. Lakas determined that A.H.R. “require[d] skilled
rehabilitative therapy in conjunction with a home exercise program” due to his difficulties
with approximating sounds, identifying body parts, and comprehending oral directions.
Pet. Ex. 8, p. 202. A.H.R. was babbling but did not have any spontaneous jargon. Id.
Whether A.H.R. was using any words at all was not addressed in this report, but no
“spontaneous jargon” certainly suggests that A.H.R. was not using word approximations
spontaneously. Id. In one specific area, she noted a decline in A.H.R.’s performance,
recording “Decreased Identification of Body Parts.”9 Id. The tone of this report
contrasts significantly with that of the report Ms. Lakas prepared just three and one-half
months earlier. In the November 18, 2009 report, Ms. Lakas commented that she gave
the parents tips and ideas to use in helping with speech and sound production and that
therapy was not needed. Pet. Ex. 6, p. 197. This evaluation was communicated to Dr.
Reese’s office on February 11, 2010. See Pet. Ex. 4, p. 29.
A.H.R. was evaluated by Early Steps on March 16, 2010, based on a referral
dated March 11, 2010.10 Pet. Ex. 11, pp. 212 (referral), 213-16 (initial information
gathering). Based on the testing performed, A.H.R. was formally assessed on April 14,
2010 with delays in cognition, self-help, socialization, and communication of greater
than 25%. Id., pp. 217. The individual family support plan [“IFSP”] was dated April 14,
2010. Id., pp. 218-21. A speech and language evaluation took place in the family home
on April 14 as well (id., pp. 224-25), resulting in a Treatment Plan of Care signed on
April 28, 2010 by Brandi Hook, the speech and language pathologist who conducted the
evaluation, and signed on April 29, 2010 by Dr. Reese, A.H.R.’s pediatrician (id., pp.
226-27).
The Early Steps records from the initial information gathering session reflected a
number of parental concerns, including A.H.R.’s strange behaviors in playing with toys
and whether his lack of vocabulary might be associated with ASD. Pet. Ex. 11, pp. 215-
16. Petitioners reported to the evaluator that A.H.R. enjoyed playing with socks. The
evaluator noted that “[A.H.R.] will do the same with belts, string and watch them, shake
and mom notes he gets stuck with that activity. If he looses [sic] it, he will have a ‘hissy
fit.’” Id., p. 215. Her evaluation also highlighted some of A.H.R.’s peculiar behaviors, as
reported by his parents, including that he “[p]lay[ed] with toys [in a manner] different
from other children. He will observe from upside down and will observe how it works
and will move on to another activity.” Id.; see also Tr. at 110. In a section of the Early
Steps evaluation, entitled “Family’s Areas of Concern,” the form reflected a notation that
“[A.H.R.] has no words, Also is this autism? If on [spectrum], mom feels he will be on
the ‘other end.’” Pet. Ex. 11, p. 215.
9 At A.H.R.’s 15 month well-child visit, he was noted to point at body parts appropriately; at the 18 month
visit, he failed the milestone of naming body parts appropriately. Pet. Ex. 4, pp. 66, 72. When reading
the speech evaluation in conjunction with the pediatric records, the problem of whether decreased
identification of body parts represents a true loss of skills is unclear, but what is clear is that Ms. Lakas
had altered her impression of A.H.R.’s development and now saw real problems.
10The referral and initial information gathering took place before the March 24, 2010 sick-child visit. Pet.
Ex. 11, pp. 212-16.
5
A.H.R. saw Dr. Reese on March 24, 2010. The listed reasons for the visit were a
fever, runny nose, and sneezing. Pet. Ex. 4, p. 75. On examination, A.H.R. had a fever
of 101° and bilateral bulging and erythematous ear drums. Id. Doctor Reese diagnosed
him with a URI and bilateral otitis media. Id., pp. 75-76. According to the medical
records, A.H.R.’s parents raised concerns about his lack of speech and unspecified
“self-stimulating” behaviors. Id., p. 75. Doctor Reese diagnosed A.H.R. with an
unspecified developmental disorder. Id., p. 76. The next day, Dr. Reese completed a
referral of A.H.R. to a neurologist. The referral type was “routine,” but the form
contained the notation “very concerned “with devel[opmental] del[ay].” Id., p. 181. It
also reflected that A.H.R. was receiving speech therapy. Id. Doctor Reese’s list of
open diagnoses reflects this visit as the date of diagnosis for “Developmental disorder,
unspecified.” Id., p. 99.
On April 14, 2010, speech and language pathologist Brandi Hook, M.S., CCC-
SLP, saw A.H.R. as a part of the Early Steps evaluation.11 Pet. Ex. 11, pp. 224-25.
This assessment was conducted in the family home, with A.H.R. and Mr. Reddy
present, as well as the Early Steps service coordinator and a developmental specialist.
Id., p. 224. He did not “readily engage” with Ms. Hook, kept his distance from her and
the other evaluators, made sporadic eye contact, and was observed to flap his arms.
Id. Using the Preschool Language Scale, A.H.R.’s auditory comprehension and
expressive communication were assessed at the level of a five-month old child. He was
“unable to demonstrate appropriate use of toys.” Id., p. 225. He did not react to voices
or sounds, and had a vocabulary consisting only of “mama.” Id. Ms. Hook wrote that
A.H.R.’s “speech and language characteristics are similar to those with Autism
Spectrum Disorders and should be further assessed.” Id., p. 225.
On April 23, 2010, pediatric neurologist Weldon A. Mauney, III, M.D., evaluated
A.H.R. at the Child Neurology Center of Northwest Florida for his “history of delayed
speech as well as suspected autistic behavior.” Pet. Ex. 12, p. 236. The patient history
form prepared for the initial visit reflected that A.H.R. was being seen by the practice for
“delayed speech, hand flapping, question of ASD.” Id., p. 286. The patient history
recorded by Dr. Mauney at the initial visit reflected Ms. Tarabay’s report that “over the
last few months,” A.H.R. had been saying syllables such as “Di-Di,” and over the last
three weeks, had been babbling frequently, a new behavior. Id. The visit notes
reflected that A.H.R. had good eye contact, but would not point to objects, imitate
behavior, and only occasionally responded to his name. Id. Doctor Mauney noted
frequent hand flapping, particularly when A.H.R. was excited, and that A.H.R. frequently
rubbed his fingers against his teeth or tongue. Id. Although Dr. Mauney’s affidavit
indicated that A.H.R. presented at this visit with “self-stimulatory facial slapping” (Pet.
Ex. 22 at 106) and that his “facial stimulation was exaggerated, constant, and physically
violent” (id. at 106-07), there is no mention of facial slapping or self-injurious behavior in
the record from this initial visit. This includes the parental history, Dr. Mauney’s
11The evaluation lists April 14, 2010 as the “Date of Consultation.” Pet. Ex. 11, p. 224. This was
apparently a follow-on to the March 16, 2010 Early Steps evaluation appearing at id., pp. 212-16.
6
observations, and the physical examination section.12 Pet. Ex. 12, pp. 236-38. The
diagnosis of a developmental speech/language disorder is the only one appearing in Dr.
Mauney’s records from this visit. Pet. Ex. 12, p. 238.
According to Dr. Mauney, Ms. Tarabay indicated that A.H.R. had frequent
tantrums. Pet. Ex. 12, p. 236. He fixated on signs at the park and lines on the football
field. Id. Doctor Mauney noted that, by history, A.H.R. “has never spoken intelligible
words, has never used multiple word phrases.” Id. His behavior was described as
“autistic-like,” with poor language function. Id., p. 237. Doctor Mauney recommended
Early Steps intervention, speech therapy, and a neuropsychological evaluation to
complete the ADOS (Autism Diagnostic Observation Schedule).13 Id., pp. 238, 288;
Pet. Ex. 4, p. 158 (referral for ADOS). He also ordered several tests including a brain
MRI, some genetic testing, a thyroid panel, and serum lead levels. Id., p. 238. The test
results were reported as normal. Id., p. 239.
On April 28, 2010, Ms. Hook signed a treatment plan of care for A.H.R.that noted
he had speech and language characteristics “similar to those with Autism Spectrum
Disorders.” Pet. Ex. 11, pp. 226-27. Ms. Hook recommended A.H.R. be evaluated by
an occupational therapist and attend speech therapy two to three times per week. Id.
This form was also signed by Dr. Reese on April 29, 2010. Id.
On May 12, 2010, occupational therapist Elizabeth Mains conducted an
evaluation at Florida Elks Children’s Therapy Services. Pet. Ex. 18, pp. 22-23. Ms.
Mains found A.H.R. had delays in language, motor, and self-help skills. Id., p. 23. She
observed that he “appears to be a sensory seeker – constantly seeking vestibular and
oral stimulation which is significantly affecting his daily functional performance.” Id., p.
23. She recommended weekly followup visits in order to address his developmental
delays, sensory issues, and low muscle tone. Id.
12 Later records from July-November 2010 continued to describe self-stimulatory behaviors with parental
reports that he rubbed his cheek and tongue with his index finger, which occurred more frequently when
excited (Pet. Ex. 12, p. 239) and unspecified self-stimulatory behavior at several visits (id., pp. 241, 243,
245). A specific report of “frequent self stimulatory behavior, consisting mainly of almost frequent and
constant swiping of the corner of his mouth with his hands and playing with her [sic] saliva. This has
caused a significant irritation require [sic] frequent application [of] ointments and creams to the perioral
tissue. This behavior has improved significantly after applying soft minced [likely meaning ‘mittens’] to the
hands” was made in December 2010. Id., p. 246. There is no specific report of self-injurious behavior in
any of Dr. Mauney’s records. The only indication that Dr. Mauney considered the self-stimulatory
behaviors to be serious is the fact that he prescribed various drug therapies to help control them. See
generally Pet. Ex. 12.
13 It does not appear that the ADOS was ever administered. See Pet. Ex. 12, p. 263 (notes from Dr.
(Ph.D.) Karen Hagerott, a psychologist, to Drs. Reese and Mauney). Doctor Hagerott indicated that her
clinical impression was “Autism—nonverbal/no language dev[elopment]—severe stereotypies.” Id. She
thought the autism diagnosis was correct and added that she did not think the ADOS would “add
diagnostic info or change treatment plan. Therefore we will hold administration unless needed for an
agency.” Id.
7
D. Subsequent Evaluations and Formal ASD Diagnosis.
A.H.R. had ear tubes placed on June 1, 2010, based on his history of ear
infections. Pet. Ex. 4, pp. 145-46, 160. He did well postoperatively. Id., p. 161.
On June 9, 2010, A.H.R. saw Dr. Reese, who spent 40 minutes consulting with
the family about A.H.R.’s lack of speech, inability to focus during his speech therapy
sessions, the neurology evaluation, and “ASD, and medical management options.” Pet.
Ex. 4, p. 79. Doctor Reese suggested a neuropsychological evaluation and continued
speech therapy. Id., p. 80. His list of open diagnoses for A.H.R. reflects this date for a
“Stereotyped repetitive movements” diagnosis. Id., p. 99.
In a followup appointment with neurologist Dr. Mauney on July 14, 2010, Dr.
Mauney noted A.H.R.’s continued self-stimulatory behavior and developmental delay.
Pet. Ex. 12, pp. 239-40. On July 27, 2010, A.H.R.’s parents completed a “Confidential
Child Neuropsychology History,” detailing his inability to use real words and his self-
stimulatory behavior. Pet. Ex. 14, pp. 402-05. However, they noted his strong eye
contact and their impression that he shared an emotional connection with his parents.
Id., pp. 402.
During A.H.R.’s two year well-child visit on September 3, 2010, he failed to meet
numerous language milestones, including naming one picture, combining words,
pointing to four pictures, and using two-word phrases. Pet. Ex. 4, p. 88. He was unable
to point to body parts. Id. He did not have a 30-50 word vocabulary. Id. Delays in
social skills were also noted. Id. He was again referred to speech therapy. Id., p. 90.
On September 7, 2010, Dr. Mauney noted that A.H.R.’s sleep EEG14 was normal
and that he was no longer taking certain medications, which included Prozac and
clonidine. Pet. Ex. 12, pp. 241, 271. During A.H.R.’s October 4, 2010 visit with Dr.
Mauney, he noted that A.H.R. had a history of “static encephalopathy with
developmental delays.” Id., p. 243.
At his speech therapy assessment on September 7, 2010, Ms. Hook commented
on A.H.R.’s “excellent attendance and family involvement.” Pet. Ex. 11, p. 231. She
also noted that, prior to a month long vacation in Ireland, A.H.R. was able to sort some
objects, had some understanding of simple cause and effect, and would touch his
mother’s hand to request her to sing, but had not adjusted back to his previous routine
upon return. Id. He babbled at times, but “still doesn’t have any meaningful words.”
She described A.H.R. as calming himself with oral stimulation, which involved putting
his fingers in his mouth and pushing secretions from side to side. Continued speech
therapy was recommended. Id.
14 An electroencephalogram (EEG) is “a recording of the potentials on the skull generated by the currents
emanating spontaneously from nerve cells in the brain. . . . [f]luctuations in potential are seen in the form
of waves, which correlate well with different neurologic conditions and so are used as diagnostic criteria.”
DORLAND’S at 600.
8
On September 15-16, 2010, A.H.R. was examined by Debbie Keremer at the
Sacred Heart Health System Autism Resource Center. Pet. Ex. 18, pp. 31-36. Ms.
Keremer noted her concerns that A.H.R.’s “profound sensory issues” were obstructing
his therapy, with specific mention of his continued self-stimulation behavior. Id., p. 31.
The history provided at the September 15, 2010 interview with both parents indicated
that “[b]y Christmas added stimming – escalating quickly from beginning of 2010
continues to increase.” Id.
Doctor Mauney noted in November 2010 that A.H.R. had “shown significant
improvement with current interventions including occupational therapy, speech therapy,
and behavioral development [] therapy.” Pet. Ex. 12, p. 245.
In March, 2011, A.H.R. saw Dr. (Ph.D.) Hagerott, a pediatric neuropsychologist,
for the first time, although Dr. Reese had made a referral to her in June 2010. Pet. Ex.
14, p. 395 (initial evaluation form); see also Pet. Ex. 4, p. 180 (form reflecting the 2010
referral). Her notes from the referral reflect that A.H.R. was non-verbal, had no imitative
skills, was intensely sensory seeking, and engaged in self-stimulatory behaviors. Pet.
Ex. 14, p. 395. She noted that he had received a thorough neurological workup and
indicated that the etiology of his condition would likely remain unknown and that
A.H.R.’s parents should pursue therapies, including the addition of ABA therapy,
designed to encourage language acquisition. Id. She stated that the autism diagnosis
was “clear [and] appropriate.” Id. Her assessment was that A.H.R.’s autism was
“severe.” Id., p. 396. She encouraged petitioners to continue with treatment by medical
“professionals well versed in child neurodev[lopmental] disorders” and to “Avoid
[treatments without] empirical data” to support them. Id., p. 396.
A typewritten page apparently prepared by petitioners was a part of Dr. (Ph.D.)
Hagerott’s records. Pet. Ex. 14, p. 398. The typewritten entries recite some of A.H.R.’s
history but another copy of the same page (id., p. 397) also contains clarifying notes by
Dr. Hagerott.15 The history indicates that petitioners “first began noticing sensory
issues” when A.H.R. was about “16-18 months” of age, “[s]pecifically [putting his] hand
to [his] mouth. This has consistently worsened.” Pet. Ex. 14, p. 397. Doctor Hagerott’s
notes indicated that A.H.R. “stopped progressing” but that there was no regression. Id.
A.H.R. was 16 months old in early December 2009, and 18 months old in early
February 2010. Petitioners also included a paragraph on A.H.R.’s sensory issues. Id.
Doctor Hagerott’s notes indicated that “last year” A.H.R. began putting a sock on his
hand and in his mouth and that “6 mos ago” he began doing something undecipherable
with saliva and his fingers to make a sound and that “now” he puts his fingers on his
lower lip, flaps and watches his fingers, or slaps his face. Id. The typewritten entries
reflect petitioners’ concerns about what “triggered” their son’s condition and that they
sought Dr. Hagerott’s opinion about vaccines and thimerosal, a link between Pitocin and
autism, genetic predisposition, gene mutation, and environmental triggers. Id.
15Mr. Reddy addressed this document during his testimony, confirming his authorship of portions of the
typewritten document, but denying either writing or making any statements similar to the handwritten
notations. Tr. at 124-25; Pet. Ex. 14, p. 397.
9
In July 2011, petitioners consulted Dr. Reese about A.H.R., indicating that they
were “not happy” with his pediatric neurologist (presumably Dr. Mauney). Pet. Ex. 4, p.
95. They discussed medications to treat A.H.R.’s self-stimulatory behavior and
“meltdowns.” Id. Doctor Reese’s records of open diagnoses reflect an autism diagnosis
as of July 13, 2011. Id., p. 99.
At an August 2011 evaluation of A.H.R.’s progress in speech therapy, he was
noted to be non-verbal, scored in the first percentile on the Preschool Language Scale,
had a vocabulary of three signs (“water, iPad and crackers”), was unable to identify
body parts or items of clothing, and poor play skills. Pet. Ex. 11, pp. 232-33. However,
he was able to “navigate an iPad in order to find games and videos he enjoys.” Id., p.
233. Intense speech therapy three to five times per week was recommended. Id.
E. Mitochondria Disorder Evaluation
On October 11, 2011, Dmitriy Niyazov, M.D., evaluated A.H.R. at the Ochsner
Clinic Foundation. Pet. Ex. 13, pp. 321-22. Doctor Niyazov noted “a history of
regression at 15 months when [A.H.R.] got 5 immunizations.” Id., p. 321; see also id., p.
294 (reciting same history). This consultation was at the request of an unidentified
individual for the purposes of evaluating “a possible genetic etiology of [A.H.R.’s]
developmental delay and autism.” Id., p. 321. Doctor Niyazov discussed the possibility
that A.H.R. might have a metabolic disorder, noting that “more and more studies now
implicate problem[s] with cellular energy metabolism such as mitochondrial dysfunction
in autism and developmental delay.” Id., p. 322. He ordered multiple tests to evaluate
whether A.H.R. suffered from a metabolic or mitochondrial disorder. Id., p. 322.
These test results were within the reference ranges (id., pp. 297-303), except for
high plasma lactic and pyruvic acids (id., p. 304) and a slightly low methylbutrylglycine
(id., p. 297). The laboratory interpretation noted that the acidemia observed could have
several causes, but if a metabolic disorder was suspected, urine organic acid studies
should be performed. Id. A “slightly low” vitamin D level was also reported. Id., pp. 305
(test results), 313 (interpretation).
During a followup visit on January 3, 2012, Dr. Niyazov reviewed the test results.
He noted that A.H.R. had:
severe developmental delay and low-functioning autism, absence of
speech, and no dysmorphic features. His brain MRI was negative and
EEG was normal. He had a history of regression from 5 vaccinations and
significant repetitive behavior and stimming which is of a great concern to
the parents. He had normal oligoarray, karyotype, fragile X and several
metabolic studies. He did have high lactate and pyruvate.
Pet. Ex. 13, p. 313.
Doctor Niyazov discussed the possibility of a metabolic disorder with petitioners,
and indicated that he would ordinarily suggest testing in a fasting state for metabolic
10
abnormalities. Id., p. 314. However, because A.H.R. was scheduled for brain auditory
response testing under anesthesia on January 24, 2012 (see id., pp. 318, 324-25), he
recommended that A.H.R. have a muscle biopsy performed at the same time in order to
evaluate him for mitochondrial dysfunction.16 Id., p. 314. While awaiting the muscle
biopsy results, Dr. Niyazov elected to treat A.H.R. empirically for a mitochondrial
disorder. Id.
A.H.R. had a muscle biopsy at Texas Children’s Hospital on January 24, 2012.
Pet. Ex. 13, pp. 328-29, 390. The biopsy results did not detect any deficiencies in the
mitochondrial electron transport chain, nor were any large deletions in the mitochondrial
DNA found. Id., pp. 385-86. A homoplasmic mutation on m.5814T>C (tRNA Cys) was
detected, but was considered a provisional rather than a pathogenic mutation.17 Id., pp.
386-87. The assessment of the physician who signed the final pathology diagnosis was
that the changes seen on the muscle biopsy were “mild,” but that an underlying
mitochondrial dysfunction could not be excluded. Id., p. 308.
During a return visit on May 14, 2012, Dr. Niyazov discussed the muscle biopsy
results with A.H.R.’s parents. Pet. Ex. 13, p. 311. He noted improvements in A.H.R.’s
sleep cycle, and attributed the progress to his recommended vitamin supplements. Id.,
p. 310. However, he also noted that A.H.R.’s self-stimulating behaviors persisted. Id.
In August 2012, Dr. Niyazov again noted A.H.R.’s persistent self-stimulating
behaviors, although there had been some improvement. Pet. Ex. 13, p. 294. He was
still nonverbal but babbled more. Id. He recorded that A.H.R.’s receptive language had
improved, and he was sleeping better and had more energy. Id.
In a letter dated October 5, 2012, Dr. Niyazov asserted that A.H.R.’s
mitochondrial disease “explains his developmental delays and autism.” Pet. Ex. 13, p.
292. According to Dr. Niyazov, “[p]atients with mitochondrial disorders are at risk for
regression if too many immunizations are given at once.” Id. He recommended that
16This test was abbreviated “ABR” in this record. It is sometimes abbreviated as “ABEP” (Auditory
Brainstem-Evoked Potentials), and is a test performed on young children or those incapable of
communication to determine if the brain is processing sounds. MOSBY’S MANUAL OF DIAGNOSTIC AND
LABORATORY TESTS (4th ed. 2010) [“MOSBY’S LABS”] at 562-63.
17 This mutation has been reported as a pathogenic (disease-causing) mutation, as it has been found in
patients with several different mitochondrial disorder syndromes, but it is also found in asymptomatic
patients. It has also been reported as a polymorphism. See Pet. Ex. 13, p. 386 (laboratory test
interpretation). A genetic polymorphism is “the long term occurrence in a population of multiple
alternative alleles at a locus, with the rarest ones being at a frequency greater than could be maintained
by recurrent mutation alone.” DORLAND’S at 1490. Both A.H.R.’s mother and maternal grandmother have
the same mutation, but do not have ASD and have not been diagnosed with a mitochondrial disorder.
Pet. Exs. 13, p. 311; 24, p. 119. Doctor Niyazov noted that the differences in their presentations could be
due to heteroplasmy, which refers to differences in number and type of mitochondria present in cells,
tissues, and organs. Id., p. 293; DORLAND’S at 856 (defining heteroplasmy as “the presence of multiple
types of mitochondrial . . .DNA within a single cell or individual.”); see also Pet. Ex. 16 at 412 (Dr.
Niyazov’s report).
11
future immunizations be given one at a time, “except for when 2-3 are bound together,”
and separated by at least one month between each one. Id.
III. Summary of Relevant Hearing Testimony.
In their hearing testimony and affidavits, petitioners acknowledged their concerns
about A.H.R.’s language delays began as early as December 16, 2009. Tr. at 73, 103-
04, 166; Pet. Exs. 9 at ¶ 10; 10 at ¶ 10. They disagreed that portions of the early
intervention records accurately reflected their reports of behavioral symptoms, but when
pressed, sometimes acknowledged that the histories might reflect the essence of their
reports. Their testimony provided additional examples of A.H.R.’s peculiar and
sometimes obsessive behaviors, as well as his significant language delays, prior to
what they described as a sudden regression, occurring on a date just inside the 36
months before they filed their petition. They offered explanations that appear to have
been carefully calculated to avoid triggering the running of the statute of limitations for
nearly every behavioral problem they had reported to therapists or physicians or which
are otherwise reflected in medical or treatment records. Throughout their testimony, the
parents often provided histories that contradicted contemporaneous medical records,
their prior statements, and their own affidavits. They contradicted one another’s
testimony on several points.
A. Mr. Reddy’s and Ms. Tarabay’s Testimony.18
Mr. Reddy and Ms. Tarabay allege that, while traveling in the family car on March
23, 2010, A.H.R. caught their attention by placing his sock in his mouth and beginning
to repeatedly stroke or slap his face and play with his tongue. Tr. at 78-82, 157-59; Pet.
Exs. 9 at ¶¶ 12-14; 10 at ¶¶ 13-15. Petitioners claim that the incident on March 23,
2010 represented an instantaneous change in A.H.R.’s behavior, which included his
immediate loss of all speech.
Mr. Reddy and Ms. Tarabay met while studying music (opera) at the Curtis
Institute of Music in Philadelphia, PA. Tr. at 6, 130. Mr. Reddy had obtained a dual law
and business degree in Dublin, Ireland, prior to beginning his music studies. Tr. at 7.
The couple married and settled in Ireland, while performing as opera singers throughout
Europe. However they traveled to Ms. Tarabay’s hometown, Pensacola, FL, to settle
there about a month before A.H.R.’s birth. Tr. at 6, 9, 130.
Mr. Reddy and Ms. Tarabay both described her pregnancy and A.H.R.’s birth as
normal.19 Tr. at 9, 132. Mr. Reddy testified that they first met Dr. Reese, A.H.R.’s
18 In response to the motion to dismiss filed by respondent, petitioners filed a joint affidavit (accompanied
by video and still photographic depictions of A.H.R.) addressing many points raised by Dr. Miller and
commenting on the Early Steps evaluation. See Pet. Ex. 23 at 109-17. The matters addressed in this
affidavit were also addressed during petitioners’ testimony, and I have thus cited primarily to the
testimony.
19Ms. Tarabay testified that A.H.R. had a perfect Apgar score. Her recollection was incorrect, as he
scored an 8 at one minute and 9 at five minutes, with 10 being the maximum score. Ex. 3, p. 23.
12
pediatrician, two to three weeks before A.H.R.’s birth in order to discuss homeschooling
and other considerations related to the scheduling demands of their musical careers.
Tr. at 11-12.
Petitioners also testified that the first year of A.H.R.’s life was quite normal. Tr. at
10, 132. Ms. Tarabay offered A.H.R.’s first birthday party as an example of his normal
first year. Tr. at 132-33. However, during A.H.R.’s Early Steps evaluation, Ms. Tarabay
had mentioned A.H.R.’s behavior at this party as a concern. Pet. Ex. 11, p. 215; Tr. at
70.
Mr. Reddy testified that the November 3, 2009 well-child visit with Dr. Reese
marked the first time he and Ms. Tarabay realized A.H.R. was behind in meeting his
speech milestones. Tr. at 15; see also Pet. Ex. 4, pp. 66-67. The November 18, 2009
visit with a speech therapist recommended by Dr. Reese temporarily relieved their
concern regarding whether A.H.R. had a serious developmental problem. Tr. at 25; see
also Pet. Ex. 6, p. 197.
However, petitioners filed telephone records from Dr. Reese’s practice shortly
after the onset hearing. Pet. Ex. 28. A December 16, 2009 record contained the
following notation: “dad would like to speak with you. [patient] doesn’t speak, mom is
concerned that [patient] may be autistic.” Pet. Ex. 28, p. 327; see also Pet. Exs. 9 at ¶
10; 10 at ¶ 10. The telephone records reflected that, in response to this concern, Dr.
Reese wrote a message to one of his staff members, prescribing “speech therapy” for
A.H.R. Pet. Ex. 28, p. 327. He prescribed speech therapy again on January 25, 2010.
Pet. Ex. 4, pp. 188-89. Neither Mr. Reddy nor Dr. Reese could recall what prompted
the January prescription. Tr. at 106-07, 218. Petitioners’ affidavits reflect that, by
December 16, 2009, they had specific concerns about whether A.H.R.’s speech delay
was a symptom of ASD. Pet. Exs. 9 at ¶ 10; 10 at ¶ 10. At the hearing, Ms. Tarabay
testified that she told a co-worker about A.H.R.’s failure to meet a speech milestone,
and that the co-worker immediately expressed concern that this meant A.H.R. might be
autistic. Tr. at 166; see also Tr. at 103-04 (Mr. Reddy’s recounting of this concern).
Mr. Reddy testified that the speech evaluation on February 3, 2010, convinced
both parents that A.H.R. required speech therapy. Tr. at 35-37. However, they
experienced difficulty in scheduling speech therapy because the therapist A.H.R. first
saw left the Andrews Institute. Tr. at 37, 109.
Mr. Reddy denied that he or Ms. Tarabay raised the issue of A.H.R.’s fascination
with specific objects as a concern during the March 16, 2010 Early Steps evaluation.
Tr. at 48. He and Ms. Tarabay also doubted that they said anything to the evaluators
that would lead them to believe that A.H.R. had a tendency to become “stuck” or
otherwise fixated on such objects. Id.; Tr. at 150. Likewise, Mr. Reddy could not recall
using the term “repetitive behaviors.” Tr. at 68. However, Ms. Tarabay later agreed that
it was likely that she and Mr. Reddy expressed concerns to the Early Steps evaluators
about A.H.R.’s fascination with specific objects. Tr. at 150.
13
In explaining the description of A.H.R.’s obsessive behavior in the Early Steps
evaluation, Mr. Reddy denied that A.H.R. became “inappropriately fixated” on DVDs.
Tr. at 57. Ms. Tarabay initially testified that she and her husband did not characterize
A.H.R.’s behaviors as repetitive during the Early Steps evaluation, but she later clarified
that she was indeed concerned whether some of A.H.R.’s behaviors were repetitive and
likely expressed her concern to the evaluators. Tr. at 150, 156-57.
Mr. Reddy explained that the Early Steps evaluation reflected an interpretation of
Mr. Reddy and Ms. Tarabay’s dialogue with the evaluators rather than a precise record
of their statements. Tr. at 42-43. He denied using the word “hissy-fit” to characterize
A.H.R.’s behavior, but acknowledged that A.H.R. had temper tantrums. Tr. at 49.
However, Ms. Tarabay confirmed her use of the phrase “hissy-fit.” She explained that
A.H.R. would enjoy particular activities “a whole lot, that he would just continue playing
with those activities and that he would not want to go play with a normal toy,” resulting
in a tantrum when he was redirected. Tr. at 150-51. Ms. Tarabay’s testimony broadly
described the type of repetitive and obsessive behaviors recorded in the Early Steps
record, despite the conflicting testimony of A.H.R.’s parents. See Pet. Ex. 11, p. 215.
The Early Steps evaluator recorded comments that appear to have originated
with one or both of petitioners: “[A.H.R.] has no words, Also is this autism? If on [autism]
spectrum, mom feels he will be on the ‘other end.’” Pet. Ex. 11, p. 215. Although Mr.
Reddy testified that neither he nor Ms. Tarabay told the evaluators that A.H.R. “had no
words,” Ms. Tarabay described the phrase “other end” as an accurate quotation and
that she was referring to the higher functioning end of the autism spectrum, such as
Asperger syndrome. Tr. at 64, 155. Ms. Tarabay also denied saying that A.H.R. “had
no words.” Tr. at 153-54. She and Mr. Reddy attempted to explain the inaccuracy of
the statement by testifying that A.H.R. used words such as “mama, da-da, ba-ba, d-d.”
Tr. at 64; see Tr. at 168. However, the telephone message left for Dr. Reese in
December 2009 also indicated that A.H.R. “doesn’t speak.” Pet. Ex. 28, p. 327.
Mr. Reddy explained that the question “is this autism?” was based on their
concern with “hype in the media,” which he described as “Jenny McCarthy” raising the
issue of autism on national television programs. Tr. at 65. Mr. Reddy maintained that,
although he and Ms. Tarabay were aware of ASD at the time of their interview at the
Early Steps evaluation, “we didn't really think there was anything wrong with [A.H.R.], or
maybe he was just a bit slow with words and maybe there are some people that are
slow to start speaking, but then they end up being fine.” Tr. at 67. In his later
testimony, Mr. Reddy explained that he and Ms. Tarabay were concerned whether
A.H.R.’s lack of speech or delayed speech milestones could be symptomatic of ASD
and described that as “an established red flag.” Tr. at 73. Again, this testimony is
belied by the December telephone message reflecting that “mom is concerned that
[A.H.R.] may be autistic.” Pet. Ex. 28, p. 327.
Additionally, the Early Steps evaluation also detailed the parents’ concern over
peculiar behaviors such as “[A.H.R.] will observe from upside down and will observe
how it works and will move on to another activity.” Pet. Ex. 11, p. 215. Mr. Reddy
14
testified that the reference to looking at objects upside down was “in relation to that
restroom at Tiger Point Park.20 “When [A.H.R.] saw the female restroom sign, he went
over and looked at it upside down, just kind of tilted his head.” Tr. at 51. He stated that
“we thought that was a little odd.” Tr. at 50. Ms. Tarabay described A.H.R.’s fascination
with the park’s restroom sign slightly differently, stating that “[A.H.R.] would play down
the slide and all this, and out of the corner of his eye on one of the occasions saw the
female restroom sign and he went over to it and looked at it.” Tr. at 110. She further
elaborated that “[A.H.R.] saw that sign on the door, he immediately went over to it, and
he did that other times, also.” Id. She confirmed that A.H.R. repeated this behavior on
more than one occasion. Tr. at 111; see also Pet. Ex. 12, p. 236 (report at initial visit
with Dr. Mauney indicating that A.H.R. was fixated on signs and the lines on the football
field). A.H.R. continued to look at things upside, as reflected by typewritten concerns
petitioners provided to Dr. (Ph.D.) Hagerott in March 2011. See Pet. Ex. 14, p. 398.
The parents provided additional context to the Early Steps evaluation description
that “when overwhelmed by lots of folks, he will not tolerate well.” Pet. Ex. 11, p. 215.
Mr. Reddy described this entry as referring to A.H.R.’s “first birthday party, and we had
a surprise birthday. When he came in, he just got overwhelmed with so many different
people.” Tr. at 70. However, he also claimed that A.H.R. recovered and “he had a
great birthday party.” Tr. at 72. Ms. Tarabay testified that the birthday party was
attended by family from Ireland and other family members who were strangers to A.H.R.
She explained: “When [A.H.R.] saw everybody, everybody was right there saying happy
birthday when we were walking in, and he got very shy and then clinging on to mommy,
so I just thought that was normal, pretty normal.” Tr. at 133. They testified that they
were not concerned about A.H.R.’s ability to socialize with other people or children. Tr.
at 70-71, 151.
The parents’ testimony regarding A.H.R. being overwhelmed by people at the
birthday party and Ms. Tarabay’s comment that she thought A.H.R.’s reaction was
“normal” does not fully explain why they mentioned A.H.R. “not tolerat[ing] well” (Pet.
Ex. 11, p. 215) large numbers of people as a specific area of concern at the Early Steps
evaluation. This remark appears in the section labeled “Family’s Areas of Concern,”
which included the “no words” comment, the question “is this autism?” and “repetitive
behaviors” as other concerns. Despite the parents’ testimony suggesting that they were
not very concerned about A.H.R. becoming overwhelmed by groups, their description of
A.H.R.’s visits to the “funplex,” a children’s facility in Gulf Breeze, FL, indicated that
A.H.R.’s lack of social engagement with people other than family members was a
problem. Under a section of the evaluation form entitled “Your Family’s
Routines/Concerns/Priorities/ Resources,” the evaluator noted that A.H.R. attended
open gym at the funplex, “but there is no social engagement, [he] will watch them but
not play with them.” Pet. Ex. 11, p. 216. Mr. Reddy testified that this entry was
misleading, in that “[t]here was an older gym class of eight- and nine-year-olds and
[A.H.R.] was whatever age he was, so there was a massive age gap between him and
the others, so….that was heavy play and he was observing.” Tr. at 53; 76-77, 113. Mr.
20 A slightly more detailed explanation from Ms. Tarabay of this behavior is contained in Dr. Mauney’s
initial visit notes. Pet. Ex. 12, p. 236.
15
Reddy also testified that A.H.R. did not avoid socialization with similarly aged children,
particularly at a park. Tr. at 53.
Mr. Reddy attempted to explain another statement from the evaluation, that “Dad
describes him using his hands in repetitive play and will often put in mouth,” testifying:
“when [A.H.R.] would get excited, he would use his hands moving up towards his face,
at this stage, he wouldn't be like -- he wasn't doing what he was doing after the 23rd of
March, he wasn't doing any self-injuries or smacking himself, but he'd bring his hands
up like this (demonstrating), kind of like excited.” Pet. Ex. 11, p. 215; Tr. at 60. He
confirmed my description of his gestures, which I described as “You took both hands
with your fingers spread and brought them up about six inches from your face and kind
of moved them back and forth….[w]aving his hands around his face.” Tr. at 60-61. Ms.
Tarabay recalled that “[A.H.R.] would get very excited and his hands would out of
excitement go to his face and then they would come down, but nothing to the point
where I thought that's obsessive behavior.” Tr. at 153. Later in his testimony, Mr.
Reddy again distinguished A.H.R.’s excitable behavior (the hand waving Mr. Reddy
demonstrated) with his behavior “after the regression when [A.H.R.] was slapping his
face.” Tr. at 112.
However, their typed comments for Dr. Hagerott indicate that A.H.R. was putting
his hands in, or at least to, his mouth far earlier than March 23, 2010. These comments
reflect that “around 16-18 months old we began noticing sensory issues. Specifically
hand to mouth. This has consistently worsened”. Pet. Ex. 14, p. 397. According to
Doctor Hagerott’s notes on this account of the hand to mouth sensory issues, A.H.R.
“stopped progressing — ø [a symbol for “no”] regression. Id. This comment was likely
the result of a follow up question regarding the “consistently worsened” phrase in the
typewritten statement and suggests that petitioners did not think A.H.R. had regressed.
What is notably absent from the typewritten comments is any report of the sudden and
dramatic regression on March 23, 2010 about which they testified.
A.H.R.’s parents both testified at some length about what happened on March
23, 2010. According to their testimony, A.H.R. caught his parents’ attention while they
were driving near their home. He took his sock off and put it in his mouth, began
grinding on it, and then “started violently slapping it and soaking the sock in saliva.” Tr.
at 79; see also Pet. Exs. 9 at ¶¶ 12-14; 10 at ¶¶ 13-15. Ms. Tarabay testified that
“[A.H.R.] started slapping his face like crazy and he was trying to make himself throw up
. . . .[by] gagging himself.” Tr. at 157. She testified that A.H.R. was “sticking his hand
down his throat and he was making the gagging sounds and trying very hard to make
himself throw up, and at the same time, slapping his face.” Tr. at 158.
Once they arrived at their home, they testified that Mr. Reddy called Dr. Reese’s
office and made an appointment for the next day. Tr. at 79, 159-60. They apparently
did not indicate that they needed to talk to someone about A.H.R.’s sudden behavioral
change or convey any sense of urgency, as there were no telephone records of a
16
message.21 Pet. Ex. 28 at 331-32. Mr. Reddy testified that he and Ms. Tarabay did not
discuss taking A.H.R. to an emergency room. Tr. at 81. Although they were both
frightened by A.H.R.’s behavior, they were able to use DVDs to calm him down that
evening. Tr. at 81, 159.
Mr. Reddy emphasized that the incident on March 23, 2010 represented an
instantaneous change in A.H.R.’s behavior, which also resulted in his immediate loss of
words. Tr. at 81-82. At one point, Mr. Reddy snapped his fingers to demonstrate that
A.H.R. acted as if “he was gone.” Tr. at 80. Mr. Reddy described this sudden change
“like a light, it was a definite change, sudden change.” Id. Similarly, Ms. Tarabay
testified that “things basically fell off a cliff” in relation to A.H.R.’s development after
March 23. Tr. at 164.
Doctor Reese’s records from A.H.R.’s sick-child visit on March 24, 2010,
reflected that the reason for the visit was A.H.R.’s fever, runny nose, and sneezing, but
after the entry “Narrative HPI,” parental concerns about “lack of speech and self
stimulating behaviors” were listed. Pet. Ex. 4, p. 75. Mr. Reddy testified that although
such symptoms were accurate, “that wasn't the reason we went.”22 Tr. at 84-85; see
Pet. Ex. 4, p. 75. Mr. Reddy thought Dr. Reese was “very concerned” with A.H.R.’s
behavior, because he referred A.H.R. to a neurologist. Tr. at 86. Ms. Tarabay testified
that A.H.R. was engaged in “[m]ajor flapping” during his March 24, 2010 visit with Dr.
Reese. Tr. at 161.
Mr. Reddy and Ms. Tarabay also discussed their visits with Dr. Mauney, a
neurologist; Dr. Hagerott, a neuropsychologist; and Dr. Niyazov, a geneticist. Tr. at 89-
90, 162. Ms. Tarabay testified that the genetic testing ordered by Dr. Niyazov revealed
that A.H.R. has a mitochondrial disorder. Tr. at 163. She and her mother have the
same mutation and “if we have a depletion in the mitochondria, our energy levels are
out of whack,” but that the mitochondrial disorder impacted A.H.R. differently because
“[t]he amount of vaccinations that [A.H.R.] was given, his body was not able to cope
with that many at one go.” Tr. at 163.
B. Dr. Reese’s Testimony.
Doctor Reese was A.H.R.’s pediatrician from birth through the time of the
hearing. Tr. at 11-12, 134, 211. He typically saw an average of 40-45 patients per day
in his practice. Tr. at 182. He described his experiences in working with children with
developmental issues, such as ASD and recalled a period around 1999 where “it
seemed like [he] was getting a new autistic patient every week for a while.” Tr. at 180-
21Pet. Ex. 28 contains about 85 pages of telephone records pertaining to A.H.R., but does not include
calls for appointments.
22This testimony indicates that Mr. Reddy was also present at the March 24, 2010 visit, although the
record for the visit indicated that “[p]atient brought by Mother.” Pet. Ex. 4, p. 75. This entry does not
appear to be a standard or form entry, as some records of other visits do not reflect who accompanied
A.H.R. See, e.g., id., pp. 70, 77. At A.H.R.’s 18 month well-child visit, he was accompanied by “[b]oth
parents.” Id., p. 72.
17
83. Although he screened children in his practice for ASD at 18-24 months of age, he
did not diagnose ASD. Tr. at 225.
Doctor Reese indicated that he had a general recollection of A.H.R. and thought
that petitioners were “excellent parents.” Tr. at 183-84, 186. In characterizing his
relationship with A.H.R.’s parents, he stated that “I have spent a lot of time with them in
the office and once in a while I see them at a restaurant and we always speak.” Tr. at
184. His tone and demeanor suggested that he had a closer relationship with
petitioners than a busy pediatrician might have with most parents of patients. He
recalled spending more time on average with A.H.R.’s parents because “they ask
appropriate questions, they show up with a list of questions and they're concerned
about the feeding and behavior and everything.” Tr. at 186, 191. In his testimony, Dr.
Reese noted that “it's very interesting to talk to them, they're from a different culture”
and added that they were the only professional opera singers in his practice. Tr. at 199.
Doctor Reese did not recall his initial referral of A.H.R. to speech therapy on
November 3, 2009. Tr. at 189; Pet. Ex. 4, pp. 66-67. He could not recall why he
prescribed a speech therapy evaluation and treatment for a speech delay on January
25, 2010, just a few days prior to A.H.R.’s 18 month well-child exam on February 1,
2010. Tr. at 218; Pet. Ex. 4, pp. 188-89. He could not recall the third speech therapy
referral at A.H.R.’s 18 month well-child visit on February 1, 2010. Tr. at 197-98; Pet. Ex.
4, pp. 72-73.
His notation that A.H.R.’s speech was “half understandable” at the 18 month
well-child visit on February 1, 2010, meant that “the parents understand half of what
[A.H.R.] says.” Tr. at 196-97. He also indicated the referral to Ms. Lakas as a speech
therapist was based on the parents’ insurance. Tr. at 200. Doctor Reese explained that
he later referred A.H.R. to Early Steps for speech therapy because Ms. Lakas had left
the Andrews Institute.23 Tr. at 221. He could not recall ever seeing the Early Steps
evaluation of A.H.R. Tr. at 222.
However, he specifically recalled A.H.R.’s sick-child visit on March 24, 2010,
because he “specifically remember[ed] him acting vastly different from any child.” Tr. at
204. He recalled that A.H.R.’s “face was red and he kept messing with his mouth and
hitting his face. . . . He was hitting his face and he was putting his hands in his mouth,
he just kept touching it.” Tr. at 205. Doctor Reese further elaborated that “I remember
him still making eye contact and looking at me in my face.” Tr. at 205. Doctor Reese
could easily recall the visit because as he stated “[t]his was very shocking -- I don't
know the right word, this was a very intense visit for me.” Tr. at 206.
Doctor Reese noted that, although he had previously treated severely autistic
patients who exhibited self-stimulating behaviors, he was shocked by the rapid
progression of the symptoms from “essentially normal, little bit of speech delay, to this.”
Tr. at 205. Doctor Reese recalled that A.H.R. did not exhibit any repetitive behaviors,
23 See Pet. Ex. 11, p. 212. This referral occurred on Mar. 11, 2010, nearly two weeks prior to the sudden
and dramatic regression petitioners described.
18
unusual sounds, or other symptoms of ASD before his March 23, 2010 sick-child visit.24
Tr. at 203. The sudden change led Dr. Reese to classify A.H.R.’s behavior as a
regression, as “even though he had a speech delay prior, now he had no words, he
wasn't talking and now he's self-stimming.”25 Tr. at 206.
Doctor Reese testified that the parents’ history of the instantaneous change in
A.H.R.’s behavior on March 23, 2010 was significant to his decision-making during
A.H.R.’s March 24 visit. Tr. at 209. When questioned about the parents’ level of
concern, Dr. Reese testified that “I remember [A.H.R.’s parents] being concerned to the
level of enough to bring him in that day and them being concerned about his behavior.”
Tr. at 206. However, Dr. Reese’s record reflects scant attention to A.H.R.’s dramatic
behavioral changes; instead, it focuses almost entirely on the URI symptoms that were
listed as the primary reason for the visit. The only mentions of behavioral concerns are
the statement: “Parents concerned b/c lack of speech and self stimulating behaviors”
listed as one of the reasons for the visit (Pet. Ex. 4, p. 75); the addition of a diagnosis of
“Developmental disorder, unspecified” for the first time (id., p. 76); and (under the
header “Treatments and instructions given during encounter”) “Continue current
therapies” “Referral to Neurology” (id.). The majority of the record was devoted to
A.H.R.’s ear and upper respiratory infections. See id., pp. 75-76.
Doctor Reese testified that, in hindsight, he should have made additional
comments in A.H.R.’s medical records, including that “I should have put that he was
known to be self-stimming in the office and that he appeared to be agitated, but not to
an extreme to where I would want to put him in the hospital.” Tr. at 205, 210-11. He
also testified that he “did a very poor job of documenting” his observations of A.H.R.’s
behavior. Tr. at 222-23, 232.
On cross-examination, Dr. Reese explained that there are three types of referrals
he could make to a specialist: “STAT,” as in “[r]ight now”; “urgent,” meaning “[p]ut it to
the top of your list”; and “routine.” Tr. at 215-16. He agreed that he characterized
A.H.R.’s referral to a neurologist as “routine.” Tr. at 223-24. He also explained that the
“chief complaint” section of his office notes would reflect the parents’ answers to a
question about why they were there that day. Tr. at 216.
In questioning Dr. Reese, I indicated that I thought he was trying to answer
questions accurately and honestly, but that I had concerns about the dichotomy
between his testimony about what he observed and what his records reflected and the
actions he took at the time. I expressed my concern about how he reported handling a
report of a sudden regression in behavior, and in particular one presenting in a child
with a fever, an ear infection, and an acute neurological problem. Tr. at 232. I asked
Dr. Reese to explain why “if a child standing in your office is hitting himself in the face
24 The previous visit was a little more than seven weeks earlier.
25The term “stimming” was misspelled in the transcript as “stemming.” In quoting from the transcript, I
substitute the correct spelling. “Stimming” refers to the many and varied self-stimulatory behaviors
displayed by many individuals with ASD.
19
while with his mother, would you write down ‘no apparent distress’…. you would not do
an immediate referral for some concern of an acute encephalopathic event?” Tr. at
232-33. Doctor Reese defended his position by testifying that he did refer A.H.R. to a
neurologist but that some mistake was made in the urgency of the referral. Tr. at 233.
However he also admitted that, under the circumstances, “I should have sent him
immediately to a neurologist or I should have called one.” Tr. at 234. He never
adequately explained why his records documented A.H.R.’s illness, but not the behavior
problems he observed.
I had similar concerns about Dr. Reese’s affidavit dated February 18, 2014 (Pet.
Ex. 21). He stated that he personally observed A.H.R. use three words (“mama,”
“dada,” and “baba”) “on multiple occasions and with purpose . . .to specifically identify
individuals.” Id. at ¶ 4a. At best, Dr. Reese had four opportunities to observe this use:
at A.H.R.’s 12 month well-child visit (Pet. Ex. 4, pp. 62-64, when he reported the use of
“mama” and “dada,” with “baba” perhaps making up the third word of the “1-3 words” he
recorded at that visit); at the 15 month well-child visit (Pet. Ex. 4, pp. 65-67, when he
referred A.H.R. to speech therapy), a sick child visit in January 2010 (Pet. Ex. 4, pp. 70-
71, at which there were no notations about developmental milestones); and at the 18
month well-child visit (Pet. Ex. 4, pp. 72-74, when he recorded several unmet speech
milestones).
This specific recollection contrasts with his testimony that he did not recall his
initial referral of A.H.R. to speech therapy in November 2009 (Tr. at 189), or why he
prescribed speech therapy and treatment in January 2010 (Tr. at 218), or the referral to
speech therapy in early February 2010 (Tr. at 197-98). It contrasts with the telephone
message in December that A.H.R. was “not speaking” (Pet. Ex. 28, p. 327).
Doctor Reese’s affidavit also stated that if A.H.R. “[h]ad [] presented with the
repetitive behaviors he manifested following his regression, as well as the obvious facial
redness and swelling due to repeated slaps to the face, it would have been documented
in my records.” Pet. Ex. 21 at ¶ 7. However, Dr. Reese did not document A.H.R.’s
presentation in the records of the March 24, 2010 visit, and did not record that A.H.R.
had a diagnosis of stereotyped repetitive movements until June 2010 (see Pet. Ex. 4, p.
79), in spite of another patient encounter with A.H.R. in May 2010 (id., pp. 77-78).
Although this was a sick-child visit, the notes reflect that the parents were seeking a
referral to a neuropsychologist (“neuropsy”), suggesting that A.H.R.’s developmental
problems were discussed during the visit. Id., p. 77. There were no comments in the
records from either the May or June visits documenting any specific repetitive or self-
injurious behaviors. I thus conclude that Dr. Reese’s assertions regarding what he
would have done are relatively meaningless, because he did not record them at the
March 24 visit when he claimed he was confronted with such behaviors.
It may be that Dr. Reese truly did see behaviors on March 24, 2010, that
concerned him and that were different from those he had previously observed, as he
made a referral to a neurologist. That does not mean that the behaviors he observed
had occurred suddenly the prior day. I note that Dr. Reese had not seen A.H.R. for
20
about seven weeks—since the 18 month checkup that had resulted in the Early Steps
referral. I also note that Ms. Hook, the speech pathologist who observed A.H.R. at the
mid-April speech evaluation, did not note any of the severe types of behavior about
which the parents and Dr. Reese testified as having occurred on March 23-24, 2010.
C. Geneticist’s Testimony.
Doctor Niyazov is a medical geneticist at Ochsner Clinic Foundation, which he
described as “the largest healthcare system in Louisiana and Southern Mississippi.” Tr.
at 245. He performed his residency and fellowship at Emory University School of
Medicine in Atlanta, GA, and is board certified in medical genetics. Tr. at 245; Pet. Ex.
16 at ¶¶ 2-3. He explained medical genetics as based on “the science of genes and
DNA.” Tr. at 246. Medical geneticists differ from basic geneticists in their interactions
with patients, as well as in using sophisticated testing to craft treatments for genetic
problems. Tr. at 246.
His primary work is focused on mitochondrial disease and autism and the
genetics of autism. Tr. at 245-46. He provides patients with the “genetic diagnosis that
can cause or can predispose [a patient] to autism,” but he does not diagnose autism or
ASD. Tr. at 247, 271. He stated that “[i]t's up to the developmental pediatrician or
psychologist's testing” to determine whether A.H.R.’s speech delay was a symptom of
ASD. Tr. at 271. He does diagnose and treat mitochondrial disease. Tr. at 247.
In testifying, Dr. Niyazov was in the difficult position of having to impeach medical
records that he created at the same time he was relying on what petitioners told him
about A.H.R.’s medical history for his opinions on diagnosis and causation.
1. Doctor Niyazov’s Records.
Doctor Niyazov’s testimony about the reliability of his records pertaining to A.H.R.
was somewhat inconsistent. The record of A.H.R.’s initial consultation on October 11,
2011 reflected a “History of Present Illness” that stated:
Andrew’s prenatal history was uncomplicated. His development has been
delayed especially in language and cognition. He started walking at 16
months of age, but he is currently averbal. His hearing is reportedly
normal. There’s a history of regression at 15 months when he got 5
immunizations. He’s been diagnosed with autism. He had significant
repetitive behavior and stimming which is of great concern to the parents.
He’s in speech and ABA therapy. His EEG and MRI were normal.
Previous karyotype and fragile X were negative.
Pet. Ex. 13, p. 321.
21
The past medical history reflected symptoms of hypotonia and drooling, and that
A.H.R. had been seen by a “DAN doctor.”26 Pet. Ex. 13, p. 321. On the physical
examination section, Dr. Niyazov wrote: “[A.H.R.] was averbal. He has not maintained
good eye contact and did not interact well with me. He frequently stimmed with his
hands.” Id.
Doctor Niyazov offered several different explanations for what he characterized
as incorrect entries in this record. The entries he identified as incorrect were: (1) the
timing of A.H.R.’s regression; (2) the age at which A.H.R. began to walk; and (3) the
information pertaining to treatment by a “DAN doctor.” Tr. at 249-50. His explanations
for the incorrect entries included a computer error, mistakes in his recollection, and a
failure to record the correct information.
In testifying about the computer error, he appeared to cast doubt on the entire
record, saying that the information in the “Past Medical History” section of the record at
Pet. Ex. 13, p. 321, did not belong to A.H.R. and involved another child.27 Tr. at 248-49.
He then temporized, indicating that it was possible he “misworded himself” and “mixed
up” a particular milestone, specifically, that A.H.R. did not walk until he was 16 months
old. Tr. at 250. He also explained that notes from an office visit might not be dictated
immediately, permitting recollection errors to creep into the records. Id. at 250.
He focused on the notation that A.H.R. regressed at 15 months of age, testifying
that this was incorrect in that A.H.R. did not regress until March 2010, as the “parents
have been telling me all along and that’s the time line that I was following.” Tr. at 250.
However, in his June 22, 2014 affidavit (Pet. Ex. 26), he dated A.H.R.’s developmental
regression as occurring “after November 3, 2009” not in March 2010.
When cross-examined about whether any of the medical records from the
Ochsner Clinic Foundation reflect that A.H.R. experienced a regression in March 2010,
Dr. Niyazov asserted that the error would have been corrected and that “those later
notes would reflect the regression in March 2010.” Tr. at 279. During the hearing, Dr.
Niyazov reviewed more recent (and, as of the hearing date, unfiled) records on his
computer and acknowledged that the more recent records repeated the same reference
to a regression at 15 months. Tr. at 284.
After the hearing, petitioners filed the more recent records from the Ochsner
Clinic Foundation, which contained a history of A.H.R.’s present illness that was nearly
identical to the one found in the earlier records. Pet. Ex. 27, pp. 206-07. The most
recent record, from June 26, 2013, specified the precise vaccinations administered to
26Defeat Autism Now! [“DAN!”] physicians subscribe to treatment protocols developed by the Autism
Research Institute. These treatments may include chelation and other therapies not vetted as efficacious
by controlled clinical studies. Dwyer, 2010 WL 892250, at *20, 178. Other than Dr. Niyazov’s record,
there is no evidence that A.H.R. was ever treated by a DAN! doctor.
27He attributed the errors to a change in the electronic medical records software, and “some of these
records did not quite transfer from one system to the other, so this is something that should not belong
there.” Tr. at 249.
22
A.H.R. “(Hib, Varicella, DTaP, flu)”28 that A.H.R.’s vaccination records show as
administered on November 3, 2009. Id., p. 206; Pet. Ex. 5, pp.195-96. Similarly, this
record repeated the history that A.H.R. walked at 16 months of age, which is relatively
consistent with his pediatric records, which show that he walked alone at 15 months of
age. Tr. at 249; Pet. Exs. 27, p. 206; 4, pp. 66-67. The other similarities between
A.H.R.’s pediatric records and Dr. Niyazov’s records likely indicate that Dr. Niyazov was
mistaken in claiming that the records filed as A.H.R.’s belong to another child, even
though there may have some errors in the history. 29
2. Mitochondrial Disorder Diagnosis and Opinions on Onset.
Doctor Niyazov testified that the speech delay noted at the 15 month well-child
visit was not related to A.H.R.’s subsequent developmental delay, and was thus not
relevant to his mitochondrial disorder diagnosis. He frequently saw patients with
speech delay but in “much more” than 50% of his patients, the delay is only temporary.
Tr. at 253-54. He noted that mild speech delays were common in boys and thought that
the November 2009 delay was likely attributable to a problem with hearing caused by
ear infections, rather than being an early symptom of ASD. Tr. 252-53, 255-58. He
disagreed that the audiogram performed in December, 2009 (see Pet. Ex. 7, p. 199)
showed normal hearing.30 Tr. at 253-57.
In opining that the speech delay in November 2009 was unrelated to the March
2010 regression, Dr. Niyazov admitted that he could not predict whether A.H.R. would
have overcome his initial speech delay, but for the regression. Tr. at 260-61. He simply
thought that hearing loss was a more likely explanation for speech delay than either
autism or mitochondrial disease. Tr. at 286. He declined to offer an opinion regarding
whether the speech delay noted at A.H.R.’s 18 month well-child visit was symptomatic
28 A.H.R. received only these four vaccinations in November 2009, although the text preceding the
parenthetical listing of the vaccinations stated that he received “five immunizations.” Pet. Ex. 27, p. 206.
It is possible that the H1N1 influenza vaccination administered two weeks later in November 2009 was
counted in reaching the total of five immunizations at 15 months of age.
29Data consistent with A.H.R.’s pediatric and other records include the uncomplicated prenatal history,
the delays in language and cognition, being averbal, the diagnosis of autism, the presence of significant
repetitive behavior and stimming being of “great concern” to the parents, the therapies mentioned, and
the other diagnostic testing performed (EEG, MRI, karyotype and fragile X tests). A.H.R. did not have a
formal diagnosis of hypotonia nor was he noted to drool as set forth in the past medical history portion of
Pet. Ex. 27, p. 206, but he had been assessed with low muscle tone (see, e.g., Pet. Ex. 18, p. 23) and his
records and the testimony established that he had a problem with saliva and oral-hand and finger contact
(see, e.g., id., p. 28; Pet. Ex. 14, p. 397).
30The audiologist who performed the test read the audiogram as normal, but did recommend a repeat
audiogram in six months “to monitor hearing sensitivity and in an attempt to obtain a more complete
audiogram.” Pet. Ex. 7, p. 199. Doctor Niyazov testified that the “gold standard” in determining hearing
loss was an auditory brain stem response test, “which was not done.” Tr. at 286. That assertion was
correct regarding the hearing testing performed in December, 2009. See Pet. Ex. 7, pp. 199-201.
However, by the time he reached his mitochondrial disorder diagnosis, A.H.R.’s hearing was confirmed as
normal by an auditory brain stem response test performed at the same time as A.H.R.’s muscle biopsy,
along with a pre-operative audiogram. See Pet. Ex. 13, pp. 324-25, 328-30, 390. Both demonstrated that
A.H.R. had normal hearing. Id.
23
of his ASD. Tr. at 268-71; see Pet. Ex. 4, pp. 72-73. To some degree, Dr. Niyazov’s
testimony that 50% or more of children with speech delay catch up to their peers (Tr. at
254) was more focused on the specificity of speech delay in diagnosis rather than
whether it was recognized by the medical community at large as an early symptom of
ASD. He indicated that he did not read the Early Steps evaluation performed on A.H.R.
prior to the events of March 24, 2010, indicating that it was “not my prerogative to judge
that” because he did not diagnose autism or developmental delays. Tr. at 272-73.
Doctor Niyazov established, at least for the purposes of this hearing, that A.H.R.
has a mitochondrial disorder.31 See Tr. at 273 (testifying that the mitochondrial disorder
diagnosis was “a fact.”). He explained that he diagnosed A.H.R. with this disorder after
receiving the results of a muscle biopsy that showed a mitochondrial DNA mutation. Tr.
at 262. He explained that he typically used the “Nijmegen criteria” in general and in
diagnosing A.H.R.32 Tr. at 288-89. He agreed that A.H.R.’s autism diagnosis was one
of the criteria he used in making the mitochondrial disorder diagnosis, and agreed with
my observation that it accounted for one point, in the category of central nervous
system dysfunction, on the score. Tr. at 288-89. He testified that A.H.R.’s “clinical
phenotype of regression and developmental delay in autism,” along with “abnormal
metabolic findings” and the muscle biopsy, all indicated that A.H.R. has mitochondrial
disease. Tr. at 262.
However, he went further in tying the two diagnoses together, testifying that
developmental delay and autism could be symptoms of a mitochondrial disorder (Tr. at
273-74) and that there was an association between ASD and mitochondrial disorders,
although he stopped short of saying that the mitochondrial disorder actually caused
A.H.R.’s ASD. Tr. at 273. He identified A.H.R.’s lack of language, “association
interaction” and stimming behaviors were a part of his mitochondrial disorder diagnosis
and a part of “developmental delay in autism.” Tr. at 274. He reluctantly agreed that if
A.H.R. had these symptoms prior to the “regression,” they could be symptoms of
A.H.R.’s mitochondrial disorder. Tr. at 274-75. In his June 22, 2014 affidavit, he clearly
described A.H.R.’s behavior after the regression as “classic autistic behavior.” Pet. Ex.
26 at 205.
Based on what the parents told him, Dr. Niyazov thought A.H.R. experienced a
developmental regression in March 2010. Pet. Ex. 16 at ¶ 8; but see Pet. Ex. 26, p. 205
(placing the regression after November 3, 2009, the date of the allegedly causal
vaccinations). He also indicated that “there were no other ‘stressor’ events during this
31 Given the procedural posture of this case and the limited purpose for the hearing, respondent did not
directly challenge the mitochondrial disorder diagnosis by producing an expert report or testimony from a
mitochondrial disease specialist. Indeed, in view of Dr. Niyazov’s assertions that A.H.R.’s ASD diagnosis
resulted from his mitochondrial disorder, it was unnecessary for respondent to challenge the diagnosis at
this hearing.
32 He did not explain which of the Nijmegen criteria he thought A.H.R. met. For purposes of this decision,
I will accept Dr. Niyazov’s testimony that A.H.R. has a mitochondrial disorder as accurate and correct.
24
time period [referring to the period between the November vaccinations and the March
23 regression] that would cause such a regression.”33 Pet. Ex. 16 at ¶ 8.
Ultimately, Dr. Niyazov’s contributions to the issue of onset of A.H.R.’s condition,
and thus to the issue of whether the petition was timely filed, were not particularly
helpful to petitioners in that he directly linked the mitochondrial disorder diagnosis to the
developmental delay and autism diagnoses. Although he waffled at one point, saying
that “the issues he had before [the regression] doesn’t [sic] necessarily have anything to
do with what happened after regression” (Tr. at 275-76), taken as a whole, Dr.
Niyazov’s testimony and his June 22, 2014 affidavit (Pet. Ex. 26) were a concession
that developmental delay and ASD were connected to A.H.R.’s mitochondrial disorder.
D. Psychologist’s Testimony.
Doctor Miller received her Ph.D. in Clinical Child and Family Psychology from the
University of Utah. Res. Ex. B at 1. She currently serves as an assistant professor of
psychology in the psychiatry department at the Pearlman School of Medicine at the
University of Pennsylvania. Tr. at 292. She lectures on ASD and has approximately 40
publications on ASD. Id., pp. 293-94. Doctor Miller also serves as the Autism Director
of an interdisciplinary and training clinic affiliated with the national Leadership,
Education and Neurodevelopmental Disabilities Program. Tr. at 295.
As part of her clinical practice, Dr. Miller has diagnosed individuals with ASD
since 1993. Such diagnoses have included cases involving developmental regression.
Tr. at 296. Doctor Miller testified that an ASD diagnosis is generally provided by a
licensed psychologist, a developmental pediatrician, or a neurologist. Tr. at 376. In
making a diagnosis, clinicians rely on the criteria provided in the Diagnostic and
Statistical Manual [“DSM”].34 Tr. at 299. An ASD diagnosis requires that a patient have
a number of characteristic symptoms but the DSM does not require that a patient have
all of the impairments listed in order in order to reach the diagnosis. Tr. at 301. ASD
manifests with impairments in social communication and restricted or repetitive
behaviors. Tr. at 297. Speech delay is not diagnostic of ASD, but remains a
recognized symptom and one commonly reported by parents and caregivers. Tr. at
301; see also R. Landa, Diagnosis of autism spectrum disorders in the first 3 years of
33 In attributing the March regression to the vaccinations received the prior November, Dr. Niyazov
referenced the mitochondrial mutation shared by A.H.R.’s asymptomatic mother and grandmother and
asserted that the “104 antigens injected straight to [A.H.R.’s] blood stream provoked an immune
response” causing A.H.R.’s regression. Tr. at 263. I note that no vaccine is injected into the blood
stream; most are administered into muscle and some are administered orally or subcutaneously.
34 The previous version of the DSM, DSM-IV-TR, was replaced in 2013 by the DSM-V. The symptoms
recognized by the medical community at large as those of an ASD did not change as a result. The
diagnostic criteria have been refined, and the distinctions drawn in the DSM-IV among the diagnoses of
autistic disorder, PDD-NOS, and Asperger’s disorder have been eliminated. See American Psychiatric
Association, Autism Spectrum Disorder Fact Sheet, available at
http://www.dsm5.org/Documents/changes%20from%20dsm-iv-tr%20to%20dsm-5.pdf (last visited August
21, 2015) (highlighting the differences between DSM-IV and DSM-V).
25
life, Nature Clinical Practice Neurol., 4(3): 138-47 (2008), filed as Res. Ex. D [“Landa,
Res. Ex. D”], at 139 (Table 1).
Doctor Miller testified that she reviewed the video evidence, medical records, and
statements from Drs. Reese, Mauney, and Niyazov in arriving at her opinions in this
case. Tr. at 306. She was the only expert witness to testify about the video evidence,
although Dr. Mauney’s one page affidavit (Pet. Ex. 25) reflected that he reviewed the
videos from December 25, 2008 through November 27, 2009, and that he did “not
appreciate any signs or symptoms of Autism or a developmental regression in A.H.R.”
and believed “they depict a normally developing child.” Id.
Doctor Niyazov’s June 22, 2014 affidavit (Pet. Ex. 26) regarding the video
evidence is unhelpful for two reasons. First, it reflected that the “regression” happened
“after November 3, 2009” (id.), and thus does not differentiate between problem
behaviors that occurred after that date and those that occurred after the purported
March 23, 2010 regression. Second, Dr. Niyazov testified that he did not diagnose ASD
and would defer to someone who did. Tr. at 271-72. Petitioners primarily commented
on the videos in their joint affidavit, Pet. Ex. 23.
Although Dr. Miller heard the testimony of petitioners and Drs. Reese and
Niyazov, she resolved the conflicts between their testimony and the “multiple
evaluations that chart this steady identification [of ASD symptoms] over time” in favor of
the records. Tr. at 349.
1. Video Evidence.35
Doctor Miller testified that the speech delay identified at A.H.R.’s 15 month well-
child checkup was the first symptom of ASD in the medical records, but found
concerning behaviors in video records of A.H.R. when even younger.
In her review of the video evidence, Dr. Miller noted that A.H.R. had “an unusual
squeal, and that stood out because there's really an absence of a lot of other babbling
or other purposeful vocalizations.” Tr. at 307; Res. Ex. E at 2-3 (referring to videos from
the first year of A.H.R.’s life). Likewise, she observed that “[h]e made some sounds that
were potentially repetitive, the a-a-a-a-a while he was shaking ribbons at his birthday
party.” Tr. at 307.
Doctor Miller observed that A.H.R.’s “facial expressions seemed flat to me and
he didn't use his body and face to communicate to other people.” Id., p. 308; Res. Ex. E
at 3. She elaborated that A.H.R. demonstrated a deficient amount of communication for
35Petitioners initially filed some video segments as exhibits attached to Pet. Ex. 23, the joint affidavit
petitioners filed in response to the motion to dismiss. See Notice of Intent to File CD filed February 20,
2014. They explained the significance of these video records in their joint affidavit. Pet. Ex. 23.
Pursuant to my order to file any additional video of A.H.R. from his birth through age two, (Order filed
March 11, 2014), additional video footage was filed as Pet. Ex. 25. Doctor Miller discussed the filed
videos in her supplemental expert report, filed as Res. Ex. E.
26
a toddler his age in the videos and also “some body twisting and some mild flapping
when he was excited.” Tr. at 308.
Doctor Miller also observed that videos of A.H.R. at around 15 months of age
demonstrated a continuation of his previous behaviors. He displayed challenges in
interacting with others. Tr. at 308; Res. Ex. E at 2-3. She testified that “he was smiling
at other people, but he didn't do things to keep the interaction going.” Tr. at 308. For
instance, Dr. Miller observed that “his dad tries to play with him. His grandma tries to
talk to him and somebody tries to play itsy-bitsy spider and it's very short, he's not doing
things to kind of keep that going.” Id.
Doctor Miller noted some additional behaviors of concern such as the lack of
“sustained play with objects. He kind of moves quickly from toy to toy and he does
things with toys that are a little bit unusual.” Tr. at 308-09; Res. Ex. E at 3. He shook
his hands in circles while he was squealing. Tr. at 309; Res. Ex. E at 3. Doctor Miller
also noticed that when eating, A.H.R. “had a routine where he would sort of bang his
spoon on the highchair before he would put it in his mouth, and he did that each time
before he put a spoon in his mouth.” Tr. at 309.
2. Medical Records.
Doctor Miller acknowledged that she approached the medical record review with
the benefit of hindsight, because an observer armed with the diagnosis can more easily
interpret earlier behaviors as abnormal or otherwise supportive of the ASD diagnosis.
Tr. at 307, 324-25. According to Dr. Miller, A.H.R.’s first symptom of ASD was the
missed speech milestone at his 15 month well-child visit with Dr. Reese. Tr. at 324.
However, on cross-examination, Dr. Miller conceded that at 15 months of age, the
differences between a child with ASD and a typically developing child would be narrow.
Tr. at 331.
Doctor Miller also testified that A.H.R. displayed many other symptoms of ASD
between the 15 month checkup and mid-March, 2010. A.H.R.’s inability to meet several
language milestones at his 18 month visit (after failing to meet one milestone at the 15
month visit ( Pet. Ex. 4, pp. 65-67)) “suggest[ed] a plateau” in his language
development. Tr. at 310. At 18 months of age, a child “should have at least six really
good words, you should be combining some words, and he's not doing that.” Tr. at 310.
Expectations for a typically developing child would include acquiring additional words
and the ability to label objects. Id.
She pointed to the February 2010 speech therapy evaluation, noting that it
contained information about other ASD symptoms, in addition to the concern about the
extent of A.H.R.’s vocabulary. The observation that “there's no jargon”36 indicated
36 She explained “jargon” as a term “used to describe repetitive sounds that are not meaningful but they
have a very repetitive quality or they might be a child's word approximations of -- it's like the beginning of
echolalia sometimes where it's a repetitive sound.” Tr. at 384. In contrast, she described atypical
jargoning as “repetitive vocalizations that have a repetitive and patterned intonation.” Tr. at 379. Doctor
27
“there's not sounds that sound like conversation or sound like a sentence….he's having
difficulty approximating sounds.” Tr. at 312; Pet. Ex. 8, p. 202. These records also
indicated that A.H.R. had trouble with speech comprehension, knowledge of body parts,
and compliance with simple oral instructions. Id.
According to Dr. Miller, the purpose of the Early Steps evaluation was to gather
the family’s concerns and ideas about their goals for their child in order to guide the
intervention team’s response. Tr. at 318. She zeroed in on the narrative of the
interview on March 16, 2010, as the primary basis for her conclusion that A.H.R. had
many symptoms of ASD before March 23, 2010. Res. Ex. A. at 3-4, 6; Tr. at 313; Pet.
Ex. 11, pp. 213-16.37 These symptoms included repetitive actions, lack of social
engagement, obsessive behaviors, and abnormal behaviors with toys and objects. Res.
Ex. A. at 3, 6; Tr. at 313-19; Pet. Ex. 11, pp. 213-16.
She observed that petitioners expressed concerns about whether A.H.R.’s
behaviors were reflective of autism, which suggested that, despite their testimony at the
hearing, they thought his repetitive behaviors and lack of speech were matters of
concern. Tr. at 319; Pet. Ex. 11, p. 215.
In reference to the Early Steps comments about A.H.R.’s behavior at the funplex,
Dr. Miller found the lack of social engagement to be a significant symptom, in that, “at
the open gym, [A.H.R.] is watching the other kids but not playing with them.” Tr. at 319;
Pet. Ex. 11, p. 216.
Doctor Miller also concluded that A.H.R.’s reported fixation with socks, belts, and
strings represented behaviors symptomatic of ASD because “while children play with
everyday objects, they often don't engage in repetitive play with any objects for very
long.” Tr. at 314. She distinguished A.H.R.’s unusual play and obsessive behaviors
with toys and objects from normal children, noting that “[m]ost children, once they figure
out a toy quickly, they use it as a toy rather than studying how the mechanics are.” Tr.
at 315. Her opinion was also influenced by A.H.R.’s fixation on signs and lines on the
football field while visiting the park (Tr. at 323), as referenced by Ms. Tarabay at the
initial consultation with Dr. Mauney (Pet. Ex. 12, p. 236).
Miller explained that some of what Mr. Reddy called babbling, such as “d-d-d,” might be best classified as
atypical jargoning or repetitive vocalization with a patterned intonation. Tr. at 379; see also Tr. at 29, 64,
168 (the parents describing A.H.R.’s words).
37 The Early Steps IFSP (individual family support plan) date of “04/14/10” appears in the header of Pet.
Ex. 11, pp. 212-23. However, the parent interviews took place on March 16, 2010. Pet. Ex. 11, pp. 212-
16 (date information gathered listed at the top of pp. 213, 215). A separate Early Steps speech and
language evaluation does not have a header (id., pp. 224-25), but the first page of the actual evaluation
has a “Date of Consultation” of April 14, 2010 (id., p. 224). The treatment plan was signed by the speech
pathologist on April 28, 2010, and by Dr. Reese on April 29, 2010. Id., p. 227. The speech and language
evaluation was conducted in petitioners’ home, with Mr. Reddy as the only parent present. Id., p. 224.
Both parents participated in the parent interviews on March 16, 2010, as they both testified about
discrepancies between what was written down and what they told the evaluators. See, infra, Section
III.A.
28
With regard to the Early Steps evaluation and petitioners’ testimony, Dr. Miller
expressed skepticism about their host of “clarifications…that most of those observations
sprinkled throughout the [Early Steps evaluation] report or notes were not what the
parents meant.” Tr. at 352; see also Tr. at 349.
Doctor Miller did not believe that A.H.R. experienced a developmental regression
on March 23, 2010, because the contemporaneous medical records did not reflect one.
Tr. at 320, 324; Pet. Ex. 4, pp. 75-76. The April 23, 2010 neurology consultation also
lacked any comment about a recent regression, although A.H.R. was clearly displaying
signs of an ASD, with Dr. Miller noting that “he's not pointing to things, he does not
imitate, and he only occasionally seems to respond to his name.” Tr. at 322; Pet. Ex.
12, p. 236.
Even assuming a regression occurred on March 23, 2010, Dr. Miller maintained
that the earliest symptom of ASD was documented at the 15 month well-child visit on
November 3, 2009. Tr. at 367. Other symptoms of ASD before the purported
regression were the repetitive and stereotypic behaviors and speech delay documented
in the Early Steps evaluation. Tr. at 347. Having symptoms of autism prior to
regression is not uncommon in ASD. Tr. at 349; see also Landa, Res. Ex. D, at 141
(regression may follow earlier abnormal development in those with ASD).
In discussing the speech and language pathologist’s direct observations of
A.H.R., Dr. Miller noted that “that [A.H.R.] was seen at home where he would be most
comfortable . . . [but] he didn't really engage with the clinician.” Tr. 320-21; Pet. Ex. 11,
pp. 224-25. A.H.R. “kept his distance from the evaluator and he engaged in some
repetitive [behaviors] or some flapping [of] his arms while he vocalized.” Tr. at 321; Pet.
Ex. 11, p. 224. Similarly, she noted that A.H.R. “also didn't speak well and he didn't
have much output. It says they couldn't assess his articulation because he had such
limited output and that he should be producing more constant sounds than he was.” Tr.
at 321.
IV. Untimely Filing.
A. Legal Standards Regarding Application of the Statute of Limitations.
The Vaccine Act’s statute of limitations provides in pertinent part that, in the case
of:
a vaccine set forth in the Vaccine Injury Table which is
administered after October 1, 1988, if a vaccine-related
injury occurred as a result of the administration of such
vaccine, no petition may be filed for compensation under the
Program for such injury after the expiration of 36 months
after the date of the occurrence of the first symptom or
manifestation of onset or of the significant aggravation of
such injury.”
29
§ 300aa-16(a)(2). The date of occurrence “is a statutory date that does not depend on
when a petitioner knew or reasonably should have known anything adverse about her
condition.” Cloer v. Sec’y, HHS, 654 F.3d 1322, 1339 (Fed. Cir. 2011) (en banc).
Additionally, the date “does not depend on the knowledge of a petitioner as to the cause
of an injury.” Id. at 1338. When drafting the Vaccine Act, Congress rejected a
discovery rule-based statute of limitations, in favor of one that does not consider
knowledge and runs solely from the date of the first symptom or manifestation of onset.
Id. at 1338-39.
Because petitioners filed their petition on behalf of A.H.R. on March 22, 2013, the
first symptom or manifestation of onset of his ASD must have occurred after March 22,
2010, in order for the petition to be considered timely. See Markovich v. Sec’y, HHS,
477 F.3d 1353, 1357 (Fed. Cir. 2007) (holding that “either a ‘symptom’ or a
‘manifestation of onset’ can trigger the running of the statute [of limitations], whichever
is first”); Cloer, 654 F.3d at 1335 (holding that the “analysis and conclusion in Markovich
is correct. The statute of limitations in the Vaccine Act begins to run on the date of
occurrence of the first symptom or manifestation of onset.”).
B. Symptoms of Autism Spectrum Disorders.38
The diagnostic criteria for ASD are set forth in Diagnostic and Statistical Manual
of Mental Disorders [“DSM”]. “Landa, Res. Ex. D” at 138. Speech delays are often the
first symptom of ASD that parents report to their child’s pediatrician. Id. at 139. Other
early symptoms of ASD recognized by parents include exploring toys in unusual ways,
poor motor skills, or regulatory problems related to attention, eating and sleep. Id., at
139-40. As Dr. Miller testified, the focus in the DSM is on deficits in social
communication and restrictive and repetitive patterns of behavior. Tr. at 297.
Additionally, self-injurious behaviors, such as A.H.R.’s repetitive face slapping, are also
commonly seen in ASD. See Res. Ex. E at 4: Res. Ex. F, N. Minshawi, et al., The
association between self-injurious behaviors and autism spectrum disorders,
PSYCHOLOGY RESEARCH AND BEHAVIOR MANAGEMENT, 7: 125-36 (2014) at 127.
There does not appear to be any dispute concerning whether these symptoms
are ones that the medical community at large would recognize as symptoms of ASD.
See Cloer, 654 at 40 (holding that “[t]he statute of limitations begins to run on a specific
statutory date: the date of occurrence of the first symptom or manifestation of onset of
the vaccine-related injury recognized as such by the medical profession at large.” See
also Markovich, 477 F.3d at 1360 (holding that “the first symptom or manifestation of
onset … is the first event objectively recognizable as a sign of a vaccine injury by the
38I have previously described the symptoms of ASD at length in White v. Sec’y, HHS, 04-337V, 2011 WL
6176064 (Fed. Cl. Spec. Mstr. Nov. 22, 2011). There does not appear to be any material dispute
regarding what constitutes a symptom of an ASD in this case, but rather when the symptoms first
presented. Although Dr. Niyazov offered an alternative explanation for the earliest speech delay
symptoms, he did not assert that speech delay was not a symptom of ASD, and he appeared to concede
that speech delay could be such a symptom. Tr. at 270-71.
30
medical profession at large.”) (internal citation and quotation omitted). Neither Dr.
Niyazov’s testimony39 nor that of Dr. Reese contradicted Dr. Miller’s testimony and the
other evidence regarding ASD symptomatology. Doctor Mauney possessed the
requisite qualifications to opine whether a specific behavior or missed milestone would
be a symptom of ASD recognized by the medical community at large. However his
affidavit did not exclude speech delay as a symptom of ASD; he merely opined that
missing one milestone with regard to speech would not be a sign or symptom of ASD.
Pet. Ex. 22 at 107.40
To the extent Dr. Mauney’s affidavit conflicts with Dr. Miller’s reports and
testimony regarding what constitutes a symptom of ASD, I relied more heavily on Dr.
Miller’s testimony and reports. I note that, in spite of language delay and other ASD
symptoms appearing in Dr. Mauney’s records, the filed records never indicated that he
diagnosed A.H.R. with ASD. Rather, he repeatedly diagnosed a speech and language
developmental delay and at least twice recommended that A.H.R. be tested for ASD
using the ADOS. See, e.g., Pet. Ex. 12, pp. 239-40; 246, 288.
C. Determining Onset of A.H.R.’s Symptoms.
In determining onset of A.H.R.’s ASD symptoms, I relied primarily on the
testimony of Dr. Miller, rather than that of Drs. Reese and Niyazov, given her greater
expertise. Both Drs. Reese and Niyazov testified that they did not diagnose ASD.
The primary areas of controversy are whether A.H.R.’s November 2009 speech
delay was a symptom of ASD; whether to credit petitioners’ testimony over the
contemporaneous medical records regarding A.H.R.’s behavioral symptoms before the
events of March 23, 2010; and whether A.H.R. experienced a developmental regression
on March 23, 2010. For purposes of resolving the motion to dismiss based on untimely
filing, it is unnecessary to resolve the issue of whether a developmental regression
occurred, as I find that there is ample evidence that A.H.R. experienced developmental
delay and symptoms of autism more than 36 months prior to the filing of this petition.
The legal standards applicable to resolving factual conflicts are set forth below,
followed by my factual findings and the reasons therefor.
1. Legal Standards.
39See Tr. at 271 (Dr. Niyazov’s testimony that determining whether speech delay was a part of A.H.R.’s
ASD was not his call, and that this decision should be made by a developmental pediatrician or based on
a psychologist’s testing).
40Doctor Mauney did opine that, based on his “review of the aforementioned records, there was no
indication, sign, or symptom prior to March 24, 2010 that [A.H.R.] was suffering from an autism spectrum
disorder.” Pet. Ex. 22 at ¶ 9. The problem with this opinion is that either Dr. Mauney did not receive a
copy of A.H.R.’s 18 month evaluation by Dr. Reese, which contained evidence of more than one missed
milestone, or he did not read the record carefully. Furthermore, the Early Steps evaluation was not listed
as one of the documents he received. Id. at ¶5. Thus, his opinion that there was no indication that
A.H.R. exhibited any of the behaviors he saw in April 2010 prior to March 24, 2010, and that there was no
evidence he suffered from an ASD prior to March 24, 2010 was not a fully informed one.
31
Special masters frequently accord more weight to contemporaneously-recorded
medical symptoms than those recounted in later medical histories, affidavits, or trial
testimony. “It has generally been held that oral testimony which is in conflict with
contemporaneous documents is entitled to little evidentiary weight.” Murphy v. Sec’y,
HHS, 23 Cl. Ct. 726, 733 (1991) aff'd, 968 F.2d 1226 (Fed.Cir.1992), cert. denied, 506
U.S. 974 (1992) (citation omitted). Memories are generally better the closer in time to
the occurrence reported and when the motivation for accurate explication of symptoms
is more immediate. See Reusser v. Sec’y, HHS, 28 Fed. Cl. 516, 523 (1993).
Inconsistencies between testimony and contemporaneous records may be overcome by
“clear, cogent, and consistent testimony” explaining the discrepancies. Stevens v.
Sec’y, HHS, No. 90-221V, 1990 WL 608693, at *3 (Fed. Cl. Spec. Mstr. Dec. 21, 1990).
Medical treatment records are generally considered to be trustworthy evidence.
Cucuras v. Sec’y, HHS, 993 F.2d 1525, 1528 (Fed. Cir. 1993) (“Medical records, in
general, warrant consideration as trustworthy evidence. The records contain information
supplied to or by health professionals to facilitate diagnosis and treatment of medical
conditions. With proper treatment hanging in the balance, accuracy has an extra
premium.”).
2. Experts and Qualifications to Opine.
Expert qualifications play a significant role in the weight given to expert opinions,
particularly when the opinions expressed are otherwise inadequately supported by
reliable evidence. See Moberly v. Sec’y, HHS, 592 F.3d 1315, 1325 (Fed. Cir. 2010)
(“Weighing the persuasiveness of particular evidence often requires a finder of fact to
assess the reliability of testimony, including expert testimony, and we have made clear
that the special masters have that responsibility in Vaccine Act cases.”) (citations
omitted).
A.H.R.’s treating physician, Dr. Reese, testified that he has experience working
with pediatric patients afflicted by behavioral developmental issues, such as ASD. Tr. at
180-83. His affidavit claims that “[p]rior to joining Pensacola Pediatrics, I spent time in a
developmental clinic treating children with learning disorders or developmental delays
who were referred to the practice by their treating doctors.” Pet. Ex. 15 at ¶ 2 (citing
Pet. Ex. A. “C.V. of Dr. Reese,” which was apparently never filed).
Petitioners’ second expert, Dr. Niyazov, is a medical geneticist at Ochsner Clinic
Foundation, where his primary practice focuses on the issues of mitochondrial disease,
genetics, and autism.41 Tr. at 245; Pet. Ex. 16 at ¶¶ 1, 3. He testified that in
determining whether A.H.R.’s speech delay during his 15 month well-child visit was
related to A.H.R.’s ASD, “[i]t's up to the developmental pediatrician or psychologist's
41 During his later testimony, Dr. Niyazov clarified that his autism expertise was in trying to identify the
cause of autism and regression. Tr. at 273. He testified that deciding what symptoms constituted a part
of an autism spectrum disorder was “up to the developmental pediatrician or psychologist’s testing. I do
not diagnose autism.” Tr. at 271 (emphasis added); see also Tr. at 272-73.
32
testing. I do not diagnose autism.” Tr. at 271, 274. He neither purported to be an
expert in diagnosing symptoms of ASD nor was he willing to opine on A.H.R.’s early
developmental delay.
Doctor Reese’s inability to recall his multiple referrals of A.H.R. to speech
therapy, on November 3, 2009, January 25, 2010, and February 1, 2010, caused me to
question either his ability to recall or his credibility. Tr. at 189, 197-98, 218; Pet. Ex. 4,
pp. 66-67, 72-73, 188-89. When the telephone records from December 16, 2009 were
filed, in which A.H.R.’s inability to speak was documented, my concerns about the
reliability of his testimony were made even more acute. Pet. Ex. 28, p. 327.
Doctor Reese testified that A.H.R. did not exhibit any repetitive behaviors,
unusual sounds, or other symptoms of ASD before his March 23, 2010 sick-child visit.
Tr. at 203. He also testified that he had no recollection of reviewing the Early Steps
evaluation (Tr. at 222), but I note that his signature appeared on the speech and
language treatment plan prepared as a part of the Early Steps assessment (Pet. Ex. 11,
p. 227). Doctor Reese explained that he referred A.H.R. to Early Steps for speech
therapy instead of the Andrews Institute because of Ms. Lakas’s departure from the
Andrews Institute. Tr. at 221. It is true that Ms. Lakas departed the Andrews Institute,
but the specific timing of her departure is unclear. I think it more likely that he made the
referral to Early Steps rather than just to another speech therapist because of the
parents’ concerns about their child having ASD. See Pet. Exs. 28, p. 327; 11, p. 215;
Tr. at 64, 73, 104.
In contrast, respondent’s expert, Dr. Miller, holds a Ph.D. in Clinical Child and
Family Psychology and has 20 years of experience in research and clinical care for
individuals with ASD. Res. Exs. A at 1; B at 1. Doctor Miller serves as an assistant
professor of psychology in the psychiatry department at the Pearlman School of
Medicine at the University of Pennsylvania. Tr. at 292. She continues to lecture on
ASD and has produced around 40 publications on the subject, mostly related to the
early diagnosis and classification of ASD. Id. at 293-94; Res. Ex. B at 4-11. Doctor
Miller also serves as the Autism Director and Clinical Training Director for the Center for
Autism Research at the Children’s Hospital of Philadelphia. Tr. at 295; Res. Exs. A at 1;
B at 1. As part of her work at the Children’s Hospital of Philadelphia, she oversees a
psychology training program for developing experts in ASD diagnostics. Res. Ex. B at
1.
Doctor Miller’s observations of the video evidence of A.H.R. were particularly
informative. Tr. at 307-09. She noted additional instances of A.H.R.’s behaviors, such
as his repetitive and obsessive behaviors and his impairments in social communication,
which were consistent with the reports in the Early Steps evaluation. Id.; Pet. Ex. 11,
pp. 213-15.
Doctor Miller’s interpretation of the Early Steps evaluation was a coherent
narrative that complements and reinforces information contained in A.H.R.’s other
medical records. Tr. at 318-20; see Pet. Exs. 4, pp. 66-67; 11, pp. 215-16; 13, p. 321;
33
28, p. 327. Doctor Miller refused to accept much of the testimony from petitioners and
their witnesses at face value, as accepting it would require her to “disregard the multiple
evaluations that chart this steady identification of autism over time.” Tr. at 349. Doctor
Miller’s opinions are rational and are well-supported by A.H.R.’s medical records. Most
critically, even if I were to find that the alleged developmental regression occurred just
as petitioners and Dr. Reese testified, Dr. Miller’s conclusion remained unwavering
because a regression would not be inconsistent with A.H.R.’s displaying symptoms of
ASD at an earlier date. Tr. at 347.
While I appreciate Dr. Reese’s role as A.H.R.’s treating physician and his first-
hand observations of A.H.R.’s development and the concerning behaviors he displayed
on March 23, 2010, Dr. Miller has superior knowledge about the symptoms and
diagnosis of ASD and, in particular, in identifying the early symptoms of ASD. Based on
their respective medical backgrounds, I placed a greater weight on the expert opinion of
Dr. Miller regarding the onset of A.H.R.’s ASD symptoms than the opinions of Drs.
Reese and Niyazov.
My concerns about Dr. Mauney’s affidavit about what he observed at the initial
visit with A.H.R. are addressed elsewhere. I cannot accept his opinions on the signs
and symptoms of ASD and whether and when they were present in A.H.R., as it
appears that he was presented with medical records for review that were less than
complete. An expert’s opinion is only worth as much as the facts upon which it is
based. Dobrydnev v. Sec’y, HHS, 566 Fed.Appx. 976, 982-83 (Fed. Cir. 2014) (citing
Brooke Group Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993));
Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl.1980).
3. Factual Findings.
In general, I placed more reliance on the contemporaneous medical records and
videos, and histories provided when petitioners were seeking medical treatment or
therapies for A.H.R. than on evidence prepared or presented after litigation
commenced. I find that the parents’ statements contained within A.H.R.’s medical
records, made contemporaneously with his treatment, retain appreciably higher indicia
of reliability than their inconsistent, convoluted, and sometimes disingenuous hearing
testimony.
Instead of providing clear, cogent, and consistent testimony explaining the
discrepancies between their affidavits and testimony and the contemporaneous records
and histories provided before they filed their claim, Mr. Reddy and Ms. Tarabay’s
testimony repeated the refrain that they were misunderstood, misquoted, or their reports
were taken out of context regarding A.H.R.’s gradual development of ASD. This might
happen with one health care provider or in one record, but not in every record in which
symptoms were recorded that placed their claim outside the statute of limitations.
34
a. First symptoms of ASD/Developmental Delay.
I find that A.H.R. displayed symptoms of speech delay before the allegedly
causal vaccinations were administered; specifically, he did not use five to ten words at
his 15 month checkup. As there was no evidence of a sudden loss of language when
Dr. Reese reviewed A.H.R.’s developmental milestones at this November 3, 2009 visit,
the delay in language existed before the vaccinations were administered. Additionally,
the video evidence reviewed by Dr. Miller suggested problems in language
development, social communication (facial expression and body language), and some
mild hand flapping in videos taken before the November 2009 vaccinations were
administered.
I find that, notwithstanding Dr. Mauney’s assertions that missing one language
milestone is not a symptom of ASD, Dr. Miller’s testimony that language delay is indeed
a symptom of ASD recognized by the medical community at large as symptomatic, but
not diagnostic of, ASD is correct. I note that Dr. Miller’s testimony was well-supported
by Landa, Res. Ex. D, Table 1. Table 1 reflects that delayed receptive and expressive
language and low diversity in consonants produced communicatively are both
symptoms commonly reported in children at 9-14 months of age who were later
diagnosed with ASD. The article also reflects that about 80% of parents of children with
ASD had noticed abnormalities in their child by 24 months of age, and that these
abnormalities “usually involve delays in speech and language development.” Landa,
Res. Ex. D, at 139. Petitioners acknowledged his low production of sounds, specifically
referring to the “di, di, di” sound, and the very few words he spoke at 15 months of age.
b. Parental Concern about ASD Predating the Alleged Regression.
Assuming, arguendo, that Dr. Mauney was correct in asserting that the missed
milestone at 15 months of age did not constitute an early symptom of ASD or that Dr.
Niyazov was correct in attributing the missed milestone to a hearing problem, I find that
the next symptom of ASD was the parental concern about lack of speech and possible
autism expressed in the December 16, 2009 telephone record from Dr. Reese’s
practice. This record, when read in concert with the history they provided in September
2010 to the evaluator at the Sacred Heart Health System Autism Resource Center
(mentioning the onset of A.H.R.’s self-stimulatory behaviors at around Christmastime
2009 (see Pet. Ex. 18, p. 31)) and their expressed concern about autism, likely
encompassed more than A.H.R.’s lack of speech.42 The December 16, 2009 record
contradicts petitioners’ claim that “[A.H.R.] did not manifest any symptom of his vaccine-
related injury prior to his sudden regression on March 23, 2010.” Pet. Resp. at 1. I also
note that Dr. Reese referred A.H.R. to speech therapy on at least three occasions
before March 23, 2010, and only one of these could have been prompted by the
departure of the initial speech therapist at the Andrews Institute. Thus, the problem with
A.H.R.’s language development at 15 months of age persisted in the following months.
42The December 16, 2009 telephone record was not addressed by Mr. Reddy, Ms. Tarabay, or Dr.
Reese at the hearing because it had not been filed. The telephone records (Pet. Ex. 28) were filed
shortly after the two-day onset hearing in Pensacola, FL.
35
c. Other ASD Symptoms with Onset Prior to the Alleged Regression.
Assuming, arguendo, that Dr. Niyazov was correct in attributing the delay in
expressive language at 15 months of age to a hearing loss and that the speech delay
resulted from the hearing loss was the sole prompter for the December telephone call
about A.H.R. not speaking, the first symptoms of ASD were documented in the Early
Steps records from the evaluation ordered on March 11, 2010, and conducted on March
16, 2010.
In making this finding, I accept that medical records may not always be complete
or accurate and that a parent may report one thing while the evaluator writes down
another. However, I find these records to be accurate in documenting A.H.R.’s behavior
at the time (mid-March 2010) that they were made. Specifically, I find reliable evidence
in the Early Steps record that A.H.R. had significant delays in social communication,
cognition, and self-help skills. He displayed abnormal play skills and he engaged in
repetitive and stereotypic activities. He had unusual fascinations with socks, belts, and
string, and became over-focused or “stuck” on activities. I find that A.H.R. used his
hands in repetitive motions and placed them in his mouth with sufficient frequency that
Mr. Reddy mentioned this habit to the evaluators. I also find that petitioners expressed
concern about autism as an explanation for A.H.R.’s behavior at this visit—the same
concern they had expressed in December 2009 to Dr. Reese’s staff.43
I carefully considered Ms. Tarabay’s and Mr. Reddy’s testimony and their joint
affidavit addressing onset of A.H.R.’s distressing behaviors. I am confident that they
believed what they said at the hearing and in the affidavit, but their attempts to explain
away virtually every behavioral manifestation of ASD reflected in the Early Steps
records were unavailing. Either petitioners volunteered the information that appears in
the fairly detailed Early Steps evaluation records based on a growing concern about
whether A.H.R.’s behaviors were abnormal, or something in the referral or what the
parents said prompted the evaluators to ask searching and detailed questions about
specific areas of behavior. I conclude that petitioners’ question about autism triggered
the depth of the inquiry reflected and petitioners answered the questions in the manner
the exhibit reflects.
In support of my decision to credit the contemporaneous medical records over
the parents’ testimony, I note that virtually every behavior described at the Early Steps
43Ms. Tarabay and Mr. Reddy’s question during the March 16, 2010 Early Steps evaluation as to whether
A.H.R.’s lack of speech and other behaviors were symptomatic of ASD also documented their concern
about his development. This was one of the few statements attributed to them during the evaluation that
both parents did not attempt to “explain away” at the hearing. This question is essentially the same one
Mr. Reddy communicated to Dr. Reese’s staff as reflected in the telephone message on December 16,
2009. See Pet. Ex. 11, p. 215; Pet. Ex. 28, p. 327; See also Pet. Ex. 12, p. 236 (parents indicating to Dr.
Mauney that A.H.R. “has never spoken intelligible words.”) (emphasis added). While a co-worker’s
concern may have triggered the parents’ initial inquiry to Dr. Reese in December, the concern persisted
and was repeated three months later. This reflects more than a causal inquiry based on a co-worker’s
comment.
36
evaluation also appeared as an area of concern later. These later incidences of the
same behaviors documented in the Early Steps evaluations completely undercut
petitioners’ attempts to discredit the Early Steps records. I accept that A.H.R.’s
behaviors worsened over time, a progression not uncommon in ASD, but I find no
reliable evidence that A.H.R. lost skills that he once displayed.
Moreover, petitioners’ testimony regarding A.H.R.’s March 16, 2010 Early Steps
evaluation contains inconsistencies and contradictions. At times Ms. Tarabay even
contradicted herself. See Tr. at 156-57. Perhaps the most serious of these conflicts is
their denial that they told the Early Steps evaluators in mid-March that A.H.R. “has no
words,” particularly in view of the December 16, 2009 telephone record from Dr. Reese
which indicated that “[Patient] doesn’t speak, mom is concerned that [patient] may be
autistic.” Compare Tr. at 64, 67, 153-55, 168, with Pet. Ex. 28, p. 327 and Tr. at 73.
(1) Speech Problems.
The record as a whole demonstrates that A.H.R.’s early speech problems at 15-
18 months of age became a consistent concern prior to March 23, 2010. The speech
therapy records from February reflected five specific areas of concern, which included
both expressive and receptive language issues, as well as a possible loss of a skill
previously demonstrated—the ability to point to body parts upon request. At the March
16 Early Steps evaluation, he was reported to have “no words,” virtually the same report
Mr. Reddy made (“doesn’t speak” (Pet. Ex. 28, p. 327)) in December 2009. He scored
poorly on the speech evaluation conducted on April 14, 2010. His parents described his
speech to Dr. Mauney on April 23, 2010 as never including intelligible words; he was
nonverbal during Dr. Mauney’s examination. A.H.R.’s speech delay persisted, and by
the time he was seen by Dr. Hagarott, he was nonverbal. Thus, the “no words”
comment in the Early Steps records correctly reflects the state of A.H.R.’s expressive
language. As the initial audiology examination showing normal hearing was later
confirmed by an auditory brain stem response test performed at the same time as
A.H.R.’s muscle biopsy, along with a pre-operative audiogram, it is unlikely that A.H.R.’s
speech problems ever reflected a hearing loss.
(2) Abnormal Fixations, Fascinations, and Play Behaviors.
Petitioners’ own descriptions of A.H.R.’s actions on March 23, 2010, reflect a
fixation on a sock, the same item described in the Early Steps evaluation as a play item
that he looked at and the loss of which would cause a temper tantrum (“hissy fit”) when
he lost track of it or it was removed.
The Early Steps evaluation completed on March 16, 2010, described A.H.R. as
“moving his hands in repetitive play” and “often” putting them in his mouth. This is very
similar to the descriptions petitioners provided to Dr. Mauney about A.H.R.’s self-
stimulatory behaviors on April 24, 2010, and with the arm flapping Ms. Hooks observed
at the mid-April speech and language evaluation.
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Thus, regardless of what the parents observed on March 23, 2010, A.H.R.
displayed abnormal play and fixations on objects prior to the events of that day, and at a
time that placed onset of these ASD characteristics outside the statute of limitations.
(3) Eye Contact.
The Early Steps evaluation completed on April 14, 2010 described the presence
of “some eye contact.” This is consistent with what Ms. Hooks observed at the Early
Steps speech and language evaluation of “sporadic eye contact” in mid-April 2010. At
Dr. Mauney’s initial visit later in April 2010, A.H.R. had good eye contact. I conclude
that A.H.R.’s eye contact was not entirely normal in April 2010, but cannot conclude that
his diminished eye contact began at a period outside the statute of limitations.
d. Regression on March 23, 2010.
In view of the clear symptoms of ASD present prior to March 23, 2010, it is not
necessary to determine if A.H.R. actually experienced a loss of skills once reliably
demonstrated (the definition of a regression used by Dr. Reese in his affidavit (Pet. Ex.
21 at ¶ 5)). Although both Drs. Reese and Mauney described self-injurious behaviors
occurring at their first visits with A.H.R. after March 23, 2010, their medical records do
not reflect them. Doctor Mauney’s record merely reflects a parental report of rubbing a
finger on face and tongue, not slapping or hitting. Petitioners’ testimony describing
A.H.R.’s slapping himself on March 23 was similar to the testimony of Dr. Reese
describing what he observed on March 24. Compare Tr. at 79, 83, 157-158 with Tr. at
205. However, Mr. Reddy testified that A.H.R.’s behavior on March 24 was more
muted, explaining that the new environment of the doctor’s office calmed him and
A.H.R. “definitely presented [the previous day] as a totally different child than Dr. Reese
would have seen.” Tr. at 84.
Dr. Reese’s classification of A.H.R.’s behavior on March 24, 2010 as a
regression because “even though he had a speech delay prior, now he had no words,
he wasn't talking and now he's self-stimming,” (Tr. at 206) is inconsistent with his own
records, which reflected that A.H.R. was not talking in December. I do not give much
weight to Dr. Reese’s affidavit describing the words that A.H.R. spoke prior to March 24,
2010 (see Pet. Ex. 21, ¶ 4), given that these words were not recorded in the medical
records, Dr. Reese saw approximately 40 patients per day, he had received the
February speech and language evaluation reflecting significant speech problems, and
that his affidavit was prepared nearly four years later after the events in question.
If A.H.R. was truly behaving in a manner “vastly different from any child,” at the
March 24, 2010 visit, I would expect that visit’s records to indicate something other than
the routine visit recorded. Tr. at 204, 232; Pet. Ex. 4, pp. 75-76 181. I would expect
that the neurology referral would have reflected a sense of urgency. Instead, it was a
routine referral. Pet. Ex. 4, p. 181. While physicians and their staffs are not immune to
mistakes, the entirety of what Dr. Reese recorded and did at the March 24, 2010 visit
does not reflect the acute concern about which he testified and wrote in his affidavits. I
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also note that he did not include a diagnosis of repetitive and stereotypic disorder until
June 2010, whereas his other diagnoses on the list of open diagnoses were recorded
when he observed them. At the March 24 visit, the diagnosis he recorded was
“Developmental disorder, unspecified.” Id., p. 104.
Doctor Niyazov’s reliance on vaccines being the only possible explanation for a
mitochondrial regression occurring on March 23, 2010, may well be misplaced. On that
date, A.H.R. was acutely ill with an upper respiratory and ear infection and presented
with a fever.
Assuming, arguendo, that this event, occurring more than four months after the
allegedly causal November 2009 vaccination, did constitute the manifestation of a
mitochondrial disorder, the claim is still untimely. Petitioners are seeking compensation
for a developmental delay. Pet. at ¶ 16. This delay first manifested before March 23,
2010. The loss of language (characterized by petitioners in their December 2009
telephone message to Dr. Reese as “not speaking”) first occurred before March 23,
2010. Symptoms of ASD, including stereotypic behavior, dysfunctional play skills,
fascination with particular objects, and language delays, first occurred before March 23,
2010. Doctor Niyazov used A.H.R.’s diagnosis and symptoms as part of the diagnostic
criteria for the mitochondrial disorder diagnosis, thus identifying a causal relationship
between the two disorders. As the mitochondrial disorder diagnosis was partially based
on the ASD symptoms, then the first ASD symptoms were the first symptoms of the
mitochondrial disorder as well.
VI. Conclusion.
Autism spectrum disorders cannot be diagnosed by any single abnormal
behavior; they are diagnosed based on an accumulation of symptomatic behaviors.
However, the existence of any one behavioral abnormality associated with autism is
sufficient to trigger the running of the statute of limitations. Carson v. Sec’y, HHS, 727
F.3d 1365, 1369 (Fed. Cir. 2013) (“[I]t is the first symptom or manifestation of an alleged
vaccine injury, not the first date when diagnosis would be possible, that triggers the
statute of limitations under § 300aa-16(a)(2).”).
Although much of the hearing testimony concerned what actually happened on
March 23, 2010, ultimately the events of that day have little relevance to the statute of
limitations issue that necessitated the onset hearing. The symptoms of A.H.R.’s
developmental delay and ASD, ones commonly recognized as such by the relevant
medical community, occurred over the fall and winter of 2009-10, and by the time of the
Early Steps interview in mid-March 2010, A.H.R. was displaying many such symptoms.
They clearly worsened over time, a common pattern in ASD, and contributed to the
mitochondrial disorder diagnosis made by Dr. Niyazov.
The developmental delays and behavioral problems A.H.R. has are profound and
life-altering for both him and his family, and I have the greatest of sympathy for their
suffering. Nevertheless, there is preponderant reliable evidence that the first symptoms
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of his condition occurred more than 36 months before the petition was filed on his
behalf, and thus was untimely filed.
The petition is dismissed as untimely filed.
IT IS SO ORDERED.
s/Denise K. Vowell
Denise K. Vowell
Chief Special Master
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