Castaldi v. Secretary of Health and Human Services

IN THE UNITED STATES COURT OF FEDERAL CLAIMS

OFFICE OF SPECIAL MASTERS

No. 09-300V

Filed: June 25, 2014

(Not for Publication)

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

KIM CASTALDI and *

RICHARD CASTALDI, *

parents and next of kin to V.C., a minor, *

* Petitioners’ Motion for Ruling on the

Petitioners, * Record; Onset; Symptoms of Autism;

* Statute of Limitations; Insufficient

SECRETARY OF HEALTH * Proof of Causation.

AND HUMAN SERVICES, *

*

Respondent. *

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

Andrew Downing, Esq., Hennelly & Steadman, P.C., Phoenix, AZ, for petitioners.

Darryl Wishard, Esq., U.S. Dept. of Justice, Washington, DC, for respondent.

DECISION1

Vowell, Chief Special Master:

On May 12, 2009, Kim and Richard Castaldi [“Mrs. Castaldi,” “Mr. Castaldi,” or

“petitioners”] filed a petition for compensation under the National Vaccine Injury

Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 [the “Vaccine Act” or

“Program”], on behalf of their minor son, VC. On January 21, 2014, petitioners filed a

status report, in which they conveyed their belief that “the record is complete for the

Court to rule on Respondent’s Motion to Dismiss filed on August 27, 2009.”

For the reasons set forth below, petitioners have failed to demonstrate that this

case was timely filed. Assuming, arguendo, that this case was timely filed, I hold that

petitioners have failed to establish entitlement to an award. This case is therefore

dismissed.

1

Because this unpublished ruling contains a reasoned explanation for the action in this case, this

decision will be posted on the United States Court of Federal Claims' website, as required by 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.

2

National 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 (2006).

I. Procedural History.

On May 12, 2009, Mr. and Mrs. Castaldi filed a petition, alleging that the hepatitis

A vaccine VC received on May 8, 2006, caused various adverse reactions, including

irritability, fussiness, constant crying, right-sided weakness, speech regression, loss of

fine motor skills, and changes in eating habits. Petition, preamble; ¶¶ 6-7. Although the

petition did not allege that the vaccination caused VC’s autism spectrum disorder

diagnosis, the medical records and other filings reflect that these and other symptoms

led to that diagnosis.3

Petitioners filed VC’s medical records on June 25, 2009. On August 27, 2009,

respondent moved to dismiss this case as untimely filed, arguing that the medical

records demonstrated onset of symptoms of an autism spectrum disorder more than 36

months before the petition was filed. Petitioners requested and received a delay in

responding to the motion to dismiss. Petitioners’ response was filed on December 16,

2009, along with a medical report from Dr. Richard Hastings. The special master then

assigned to this case agreed to conduct a hearing to resolve conflicts in the evidence.

See Order, issued Sept. 17, 2010.

The case was reassigned to me on October 6, 2010. On October 25, 2010,

petitioners filed a supplemental response to the motion to dismiss, requesting that any

fact hearing be delayed until the U.S. Court of Appeals for the Federal Circuit issued its

decision in Cloer v. Sec’y, HHS.4 I concluded that this case presented legal and factual

issues that could be affected by the decision in Cloer and suspended any further

proceedings until that decision issued. See Order, issued Oct. 25, 2010. The en banc

decision was issued on August 5, 2011, Cloer v. Sec’y, HHS, 654 F.3d 1322 (Fed. Cir.

2011)(en banc) [“Cloer I”], and I thereafter ordered the parties to file a joint status report

proposing dates for a fact hearing. Order, issued Aug. 19, 2011.

The hearing was conducted in Tulsa, OK on December 14, 2011. At the

conclusion of the fact hearing, I indicated that the parties could file additional evidence

concerning the diagnosis of autism, including any relevant evidence from the Omnibus

Autism Proceeding [“OAP”]. When the issue of filing OAP evidence was discussed at

3

The precise diagnosis is either autistic disorder, or pervasive developmental delay-not otherwise

specified [“PDD-NOS”]. Petitioners’ Exhibit [“Pet. Ex.”] 9, pp. 61, 71-72. The most recent medical record

reflects the autism diagnosis. Pet. Ex. 8, p. 38. I note that it is not uncommon in children diagnosed with

autism spectrum disorders for the specific diagnosis within the autism spectrum to fluctuate over time.

White v. Sec’y, HHS, No. 04-337, 2011 WL 6176064, at *5 (Fed. Cl. Spec. Mstr. Nov. 22, 2011). It is also

not uncommon for health care providers to be less than precise when referring to a diagnosis on the

autism spectrum, using a general term such as PDD to refer to any disorder falling on the autism

spectrum. Id.

4

The U.S. Court of Federal Claims decision, Cloer v. Sec’y, HHS, 85 Fed. Cl. 141 (2008), was reversed

and remanded by a panel of the U.S. Court of Appeals for the Federal Circuit. Cloer v. Sec’y, HHS, 603

F.3d 1341 (Fed. Cir 2010). The panel’s decision was vacated and rehearing en banc was ordered. Cloer

v. Sec’y, HHS, 339 Fed. Appx. 577 (Fed. Cir. 2010).

2

the hearing, petitioners did not object to the use of such evidence. See Tr. at 5, 125-26.

Respondent filed five exhibits containing evidence from the OAP on December 16,

2011. On January 25, 2012, petitioners filed three articles and a motion to strike the

three exhibits containing expert testimony from the OAP concerning behavioral

symptoms of autism that respondent had filed.

On April 26, 2012, I issued my “Order and Ruling on Facts Pertaining to Onset.”

In my order, I acknowledged that “the parties’ filings in this case contemplated that I

would rule on the motion to dismiss in conjunction with this ruling setting forth factual

findings.” Ruling at 5. However, since the briefing on the statute of limitations issue

occurred prior to the Cloer I decision and because “expert reports or other evidence that

addresses the medical implications to be drawn from the facts found will inform a ruling

on whether this case is timely filed” I elected to defer ruling on the motion to dismiss. Id.

Although I granted petitioners’ motion to strike three of respondent’s exhibits, I

noted that, in light of petitioners’ late-filed objection to the exhibits,5 respondent would

be permitted to file a report of “a qualified expert addressing the early behavioral

symptoms of autism and how they apply to this case, as well as any additional

documentary evidence addressing these issues.” Ruling at 5. Additionally, given the

limited focus of Dr. Hastings’ opinion, I indicated that “petitioners, as well as respondent,

may file an opinion of an expert regarding these matters.” Ruling at 20.

I directed the parties to provide a copy of my ruling “to any expert retained to

opine on whether the behaviors identified are recognized as symptoms of an autism

spectrum disorder by the relevant medical community.” Ruling at 20. I indicated that

“[s]hould an expert disagree with any factual finding [contained in the ruling] that expert

shall clearly state: (1) the finding involved; (2) the reasons for the expert’s

disagreement; and (3) the impact, if any, of my contrary finding on the expert’s

conclusions regarding onset of symptoms.” Id. The parties were ordered to file any

additional evidence pertaining to the diagnosis of autism spectrum disorders [“ASD”] or

the import of my factual findings with regard to the onset of symptoms of ASD by no

later than June 25, 2012. The parties were also given the opportunity to file a brief

addressing the impact of the Federal Circuit’s en banc decision in Cloer I on

respondent’s motion to dismiss.

On May 9, 2012, petitioners filed a motion for review of my factual findings.

Respondent’s response was filed on May 30, 2012, and petitioners filed their reply brief

on June 7, 2012. No oral argument was held. On July 12, 2012, Judge Bruggink

denied petitioners’ motion because the case was not ripe for review.

5

My December 20, 2011 order indicated that the parties were to file any additional evidence concerning

the diagnosis of autism no later than January 13, 2012. Petitioners’ motion was filed on January 25,

2012.

3

In a July 23, 2012 status conference, I discussed resetting the deadlines for

filing additional evidence on ASD and briefs addressing Cloer I. During the call,

petitioners’ counsel indicated that petitioners would file no additional evidence or briefs.

I ordered respondent to file her expert report no later than August 22, 2012, and

September 6, 2012 was set as the deadline for the parties’ optional briefs addressing

Cloer I. Order, issued July 23, 2012.

Respondent filed an expert report from Dr. Max Wiznitzer on August 22, 2012.

Petitioners filed a response to Dr. Wiznitzer’s report two days later. In their response,

petitioners objected to the filing of the report, the “methodology” used in writing the

report, and the lack of an opportunity provided to them to cross examine Dr. Wiznitzer.

On September 6, 2012, respondent filed a brief addressing the impact of Cloer I on her

pending motion to dismiss. Petitioners made no additional filings.

I held a status conference on October 3, 2012, during which I noted that the

statute of limitations is no longer a jurisdictional bar to further proceedings. In view of

the need to resolve apparent conflicts between Dr. Hastings and Dr. Wiznitzer regarding

what behavioral symptoms constituted symptoms of autism, I suggested that an expert

hearing might be necessary.

Following the status conference, petitioners were ordered to file their

supplemental expert report no later than December 3, 2012, and respondent was

ordered to file her supplemental expert report 60 days thereafter. Order, issued Oct. 4,

2012. On November 14, 2012, petitioners requested a suspension of their filing

deadline while the Supreme Court considered Sebelius v. Cloer.6 I granted their

request on November 16, 2012. The Supreme Court issued its ruling on May 20, 2013.

Sebelius v. Cloer, 133 S.Ct. 1886 (2013) [“Cloer II”].

On June 5, 2013, I ordered petitioners to file their supplemental expert report by

no later than August 5, 2013. Instead of filing a supplemental expert report, on August

5, 2013, petitioners requested that I rule on respondent’s motion to dismiss based on

the record as it currently stands.

I held an extended status conference with the parties on October 11, 2013.

During the call, I reiterated that the factual findings contained in my April 26, 2012 ruling

were not set in stone and that if an expert disagreed with a finding, the expert could

explain the basis for the disagreement and how it impacted the expert’s opinion. See

Order, issued Oct. 16, 2013, at 5. I also indicated that I would afford petitioners one

final opportunity to file an expert report that addressed both vaccine causation and

whether VC’s behavior and actions prior to the vaccination in question were symptoms

6

The issue presented in the Supreme Court’s review was whether attorney fees and costs could be paid

in untimely filed cases. Petitioners’ concern that the expense of an additional expert report might not be

reimbursable, given the timing issue, was an adequate basis to grant additional time.

4

recognized by the relevant medical community as symptoms of ASD. I noted that if

petitioners elected not to file a report, I would rule based on the record as a whole.

On January 21, 2014, petitioners filed a status report, indicating that they would

not be filing a supplemental expert report and that the record was complete.

II. Summary of Relevant Medical Records.

VC was born in April 2004. Pet. Exs. 11, p. 109; 14, p. 662. His Apgar 7 scores

were 8 and 9, reflecting a healthy newborn. Id. He had normal growth and

development throughout his first year of life. See generally, Pet. Ex. 11, pp. 109-38.

Although he had some illnesses, including otitis media, upper respiratory infections,

rash, and viral syndrome, he had no serious illnesses or hospitalizations. Id. He

received the usual childhood vaccinations during the first year of his life. Pet. Exs. 2;

10, pp. 85-86.

At his nine-month well child visit in January 2005, VC was pulling to stand,

cruising, and engaging in vocal play. Pet. Ex. 11, pp. 133-34. He had an upper

respiratory infection at this visit. His pediatrician, Dr. Escobar, noted appropriate growth

and developmental progress. Id., p. 134.

In March 2005, VC fell and bit his tongue, prompting an emergency room visit.8

Two days later, he began vomiting and acting as if he were ill, and was taken to see his

primary care provider. Pet. Ex. 11, p. 136. Doctor Escobar indicated that he seemed

slightly tired, but was reacting normally. Id. She thought he had mild dehydration, mild

acidosis, and hypoglycemia, secondary to poor oral intake due to his sore mouth. Id.

At his 12-month well child visit on April 14, 2005, his mother reported that he had

begun walking that week. He was imitating sounds, and Dr. Escobar recorded that his

developmental progress was appropriate.9 Pet. Ex. 11, p. 138. He received his fourth

diphtheria-tetanus-pertussis [“DTaP”] and hemophilus influenza type b [“Hib”] vaccines,

and his initial measles, mumps, and rubella [“MMR”] and varicella vaccines at this visit.

Pet. Ex. 2.

7

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.

8

The emergency room records were not filed.

9

Doctor Escobar’s records did not contain any checklists for developmental screening. She testified that

she did not use formal checklists, but asked questions based on such checklists. Tr. at 32-33.

5

VC’s next physician’s visit was on July 20, 2005, for his 15-month well child visit.

He was reported to be in good health and very active. VC’s motor skills were

satisfactory. He had a “few word” vocabulary and chattered “quite a lot.” Pet. Ex. 11, p.

139. In her testimony, Dr. Escobar indicated that her notes on VC’s vocabulary were

based on parental reports, rather than her own observations. Tr. at 34.

There were no recorded physician’s visits between his 15-month and 18-month

well child checkups. Pet. Ex. 11, p. 137. At VC’s 18-month well child check-up on

October 17, 2005, Dr. Escobar recorded that his developmental progress was

appropriate. In what appears to have been her usual reliance on Mrs. Castaldi’s reports

of VC’s language development,10 Dr. Escobar stated that “mother reports that speech

development has been appropriate and is now using small phrases.” Pet. Ex. 11, p.

140. VC received an influenza vaccine at this visit. Pet. Exs. 11, p. 140; 10, p. 86.

One month later, VC was ill with a runny nose, cough, congestion, and fever. At

this November 15, 2005 visit, Mrs. Castaldi reported that VC’s older sister had also

been ill with pneumonia and tonsillitis. Doctor Escobar diagnosed VC with a probable

viral illness. Pet. Ex. 11, pp. 141-43.

VC was ill with influenza and bronchitis in late January 2006. On January 27,

2006, at the only recorded visit for this illness, VC was reported to have been ill with

cough and rhinorrhea for an unstated period of time, with a fever of 101° Fahrenheit

developing in the 24 hours preceding his visit. Testing for the influenza virus was

positive. Pet. Ex. 11, pp. 144-45, 180. The illness persisted, although the exact

duration of the illness is difficult to determine.

VC’s medical records contain an entry for March 17, 2006, reflecting a

cancellation of an optometry appointment. Pet. Ex. 11, p. 146. This cancellation may

reflect when concerns about his vision first arose.

His two-year well child visit took place on May 8, 2006, when he was just under

25 months of age. Pet. Ex. 11, pp. 146-47. There were no physician’s visits recorded

between VC’s January 2006 bout with the flu and this visit. Doctor Escobar’s record of

this visit begins, in accordance with her usual practice (see Tr. at 33), with her

handwritten notes. They reflect that VC babbled more than his sister, but, overall, was

quieter than his sister. VC had a good appetite, but disliked fruits. Doctor Escobar

noted that Mrs. Castaldi was concerned about VC’s close vision because VC bumped

into things, especially on his left side. She reported that he seemed to have trouble

focusing because he would look at something, rub his eyes, and then look at it again.

Pet. Ex. 11, p. 146.

10

Mrs. Castaldi is a speech and language pathologist who, at the time of the hearing, was the director of

special services for the Sepulpa Public Schools. This position involves oversight of early intervention and

gifted and talented programs. Tr. at 41.

6

The dictated notes11 from this visit indicated that VC was in good health. Doctor

Escobar recorded that he babbled and had a “few word vocabulary.” He liked to “talk in

sentences” as opposed to “labeling items.” Pet. Ex. 11, p. 147. Doctor Escobar

expanded on her handwritten comments on Mrs. Castaldi’s reports about VC’s vision,

noting that Mrs. Castaldi described VC as having problems with his close vision. In

looking at an object up close, VC would frequently rub his eyes and seem to try to focus

again. Id. Doctor Escobar described VC as “very active” and “inquisitive” and indicated

that he explored the exam room during the visit. Id. She referred VC for an ophthalmic

evaluation. Id. VC received the allegedly causal hepatitis A vaccine at this visit. Id.;

Pet. Exs. 2, p. 3; 10, p. 85.

VC saw Dr. Brown, an ophthalmologist, 15 days later, on May 23, 2006. Doctor

Brown noted that VC was upset and cried constantly during the examination. He

recorded that Mrs. Castaldi shared other concerns about VC’s development, specifically

his speech. Pet. Ex. 11, p. 211; see also Tr. at 81. He believed VC had a “mixed”

developmental disorder, and indicated that VC should see a neurologist or

developmental specialist. He reported that VC was farsighted.12 Pet. Ex. 11, p. 211.

Doctor Escobar received Dr. Brown’s report on May 25, 2006. Tr. at 24; Pet. Ex.

11, p. 211. She saw Mrs. Castaldi and VC again on June 8, 2006. The reason listed for

the visit was “discuss vision test results” (Pet. Ex. 11, p. 148), but it is unclear who

initiated the visit. During the visit, Mrs. Castaldi provided an additional example of why

she believed VC had vision problems. She explained that VC would eat half the food on

his plate and then want more food. When she turned the plate to place the uneaten

food in front of him, he appeared surprised that there was still food on the plate.13 Pet.

Ex. 11, pp. 149-50. Doctor Escobar also recorded that Mrs. Castaldi had concerns that

VC “has some speech delay,” that he vocalized, but had limited verbalization. He

turned to investigate sounds. Id., p. 150; see also Tr. at 84.

During Dr. Escobar’s June 8, 2006 examination of VC, she observed VC

vocalizing and using a few understandable words. She recommended that petitioners

observe VC for the next three to four months and if the symptoms persisted or

progressed, she would consider a further evaluation and a possible neurology

consultation. Mrs. Castaldi was directed to notify Dr. Escobar if there was any

exacerbation of VC’s symptoms. Pet. Ex. 11, p. 150.

11

Doctor Escobar testified that her usual practice was to take handwritten notes, and then dictate more

complete notes on the same day as the visit occurred. Tr. at 33.

12

A September 2006 report from another ophthalmologist, Dr. Siatwoski, did not indicate that VC was

farsighted. Pet. Ex. 6, p. 18.

13

The record does not indicate that this apparent inability to see all the food on his plate was a new

symptom.

7

At some point, VC was referred to “Sooner Start,” a state program for children

with special needs. Tr. at 26. VC’s initial evaluation occurred on July 31, 2006, a little

less than two months after the June visit to Dr. Escobar where she indicated that VC

should be observed for three to four months before referral. It appears that Dr. Escobar

referred VC to Sooner Start, as the initial Sooner Start record indicates “Pediatrician felt

it was best to eval—motor skills are OK, but everything else may be delayed. Possible

vision problems,” and indicated that Mrs. Castaldi had learned about the program from

her doctor. Pet. Ex. 13, p. 467. The form also indicated “Epworth T & Th,” likely

referring to VC’s attendance at a day care or preschool program those days. Id. I note

that a later record reflects VC’s attendance at Epworth “was not working out.”14 Pet. Ex.

11, pp. 151, 153; see also Tr. at 110. However, VC did attend a preschool program in

the autumn of 2006. See, e.g., Pet. Ex. 11, pp. 155-56 (note regarding possible seizure

episode while “on the way to school”).

As part of the evaluation, Mrs. Castaldi completed two questionnaires, one for

children at 27 months of age and one for children at 30 months of age, consisting of a

series of questions about developmental milestones.15 Mrs. Castaldi indicated that VC

could not follow any three-four word directions, could not correctly name at least one

picture, and could not point to body parts. Pet. Ex. 13, p. 482. Mrs. Castaldi also

reported that VC could, at one time, use a personal pronoun in the phrase “me drink,”

but that he stopped doing so in “late spring.” She indicated that VC had been imitating

three to four word sentences but that also stopped. Id. VC did not yet pretend that

objects were something else (although he sometimes engaged in pretend play with a

doll or stuffed animal), could not put things away, did not line up four objects, and could

not identify a sketch as a person. Id., p. 484. He did not eat with a fork, use “I” or

“me,”16 or don a coat or shirt. Id., p. 485. Mrs. Castaldi felt that VC’s vision issues

might be connected to some of his “regression.” She dated the regression as occurring

around the time VC had the flu, which she placed in “late spring.” Id.

On the questionnaire measuring 30 month skills, Mrs. Castaldi reported that VC

“sometimes” looked at someone speaking to him and began to resist going to Sunday

School (a church nursery program) in “late spring.” Tr. at 87, 112. He rarely greeted

familiar adults and did not like to be hugged or cuddled. Pet. Ex. 13, p. 489. She

indicated that VC did not like stories. Id. VC seemed happy and did not engage in

14

Petitioners were ordered to file any records for the period from January 2006-07 from Epworth and any

other preschool program VC attended. Ruling at 11, 20. Petitioners indicated to the court that no such

records exist. Status Report, filed May 11, 2012.

15

According to the form, the 30 month questionnaire was used for children ages 27-32 months. Pet. Ex.

13, p. 487. On July 31, 2006, VC was between 27-28 months of age. The options for scoring each skill

evaluated were “Yes,” “Sometimes,” and “Not Yet.”

16

Mrs. Castaldi checked the “Not Yet” block when asked if VC used words like “I,” “me,” or “mine.”

However, she noted that VC at one time used the phrase “me drink,” but that he stopped doing so in “late

spring.” Pet. Ex. 13, p. 482. She also checked the “Not Yet” block for a question regarding the use of

three to four word sentences, indicating that he “was imitating but also stopped.” Id.

8

hand flapping or rocking or similar behavior. Id. However, he rarely followed directions,

would not look where his mother pointed, stuffed his mouth with food, and was a picky

eater. Id., p. 490. VC preferred to play by himself, rather than alongside other children.

Id., p. 491. Based on Mrs. Castaldi’s answers, VC’s behavior fell above the cut off

score, thus warranting a referral for further evaluation. Id., p. 493.

VC was also observed at home on July 31, 2006 by the Sooner Start evaluator.

Pet. Ex. 13, p. 592. The evaluator explained that, based on the questionnaires

completed by Mrs. Castaldi, VC had delays in all areas of development except motor

skills. Id. The evaluator observed that VC appeared interested in toys. He vocalized,

but used an unintelligible string of syllables, rather than words, throughout the

evaluation. Mrs. Castaldi explained that VC had used words and imitated two word

phrases, but stopped doing so “in late spring of this year.” At this evaluation, Mrs.

Castaldi also dated VC’s regression to around the time he had the flu. Pet. Ex. 13, p.

593; see also id., p. 545 (Sooner Start provider notes from August 31 2006, indicating

that VC was speaking in sentences before he had the flu in February); Tr. at 86-87.

Sooner Start referred VC for an occupational therapy evaluation on September 14,

2006. Pet. Ex. 13, p. 579.

Doctor Escobar referred VC to Dr. Kukas, a developmental pediatrician, in late

August, 2006. Tr. at 28; Pet. Ex. 11, p. 257. Doctor Kukas first saw VC on November

4, 2006. Pet. Ex. 11, pp. 257-60; Tr. at 28. In January 2007, Dr. Kukas discussed with

Mrs. Castaldi the possibility that VC had an ASD. Pet. Ex. 11, p. 261.

VC was formally diagnosed with a pervasive developmental disorder in February

2007, after an evaluation at Cook Children’s Medical Center. Pet. Ex. 12, p. 284.

However, his parents expressed concern about an autism spectrum disorder during a

November 4, 2006 developmental pediatrics assessment (Pet. Ex. 11, pp. 257-60) and

Dr. Hille, a pediatric neurologist included autism in his differential diagnosis in his

evaluation four days later, on November 8, 2006 (Pet. Ex. 7, p. 35).

III. Summary of Relevant Hearing Testimony.

A. Pediatrician’s Testimony.

Doctor Escobar was VC’s pediatrician from birth to about age three and a half.

See generally Pet. Ex. 11. She is now retired. Tr. at 8. She testified that she took

handwritten notes during appointments and then dictated more detailed notes the same

day. Tr. at 33. She informally used the Denver Developmental Inventory [“DDI”] during

well-child visits, meaning that she did not use formal checklists to monitor development,

but the questions she asked parents about their child’s development came from the DDI

and other standard screening devices. Tr. at 32-33.

The descriptions of VC’s development, particularly his speech and language, in

Dr. Escobar’s clinical notes reflect what was reported to her by VC’s parents rather than

9

her own observations during the visit. Tr. at 34. Doctor Escobar was unable to quantify

how many words corresponded to her notations of “a few words” that appear in the

records from VC’s 15 month (July 2005) and 2 year (May 2006) well child visits. Tr. at

34-35.

She testified that petitioners were responsible parents and she would have

expected them to schedule an appointment if VC was showing signs of a neurological

condition. Tr. at 8-9. She described Mrs. Castaldi as a “speech therapist, who’s a

reliable observer.” Tr. at 36. However, Dr. Escobar also agreed that “a reliable

observer [would] give fairly consistent accounts over time of the same event.” Tr. at 38-

39.

In reviewing her consultation note from May 8, 2006, Dr. Escobar agreed that

based on her statement that VC “likes to talk in sentences as opposed to labeling

items,” and VC’s age (2 years), it appeared as though he was exhibiting normal speech

development at the time of the visit. Doctor Escobar later stated that as long as a child

was vocalizing at 2 years of age, she would have no concerns about the child’s

development.17 She would expect a two year-old to have a few understandable words,

like mama and dada. Tr. at 35.

B. Mrs. Castaldi’s Testimony.18

At the time of the hearing, Mrs. Castaldi was the Director of Special Services for

Sapulpa Public Schools. She has a Bachelor of Science degree in education and

communication science, a Master of Science in communication sciences and disorders,

and a Master of Education in school counseling. She previously was employed by the

public school system as a speech and language pathologist. Tr. at 41-42.

At 15 months, Mrs. Castaldi considered VC’s speech development age

appropriate. She had no concerns with either the number of words or the manner in

which VC used them. Tr. at 47. With regard to his speech development at his two year

well child visit (May 8, 2006), she testified that his vocabulary was “probably around 500

words,” and that he “was speaking in at least three- to four-word sentences.” Tr. at 52-

53. She indicated that she first noticed a sign or symptom of speech impairment about

17

I note that her testimony is similar to the conclusion drawn by Robert Schum, Ph.D. in his article

Language Screening in the Pediatric Office Setting. After reviewing four of the standard evaluations for

speech development, he concluded that a child should be referred for a formal speech and language

screening if by 18 months the child is not using “mama” and “dada” and if by 24 months is not using 25

words. R. Schum, Language Screening in the Pediatric Office Setting, PEDIATR. CLIN. N. AM., 54: 425-36

(2007), filed as Pet. Ex. 18 [“Schum, Pet. Ex. 18”], at 432 (Table 1).

18

After Mrs. Castaldi testified at the hearing, petitioners elected not to have Mr. Castaldi testify. They

noted that Mrs. Castaldi was the primary historian at medical visits and therefore Mr. Castaldi’s testimony

would likely be redundant. Tr. at 122-24.

10

a week before VC’s May 23, 2006 ophthalmologist appointment, specifically on May 19,

2006. Tr. at 58, 60.

Mrs. Castaldi testified that she frequently took VC to the school where she

taught. Tr. at 58. In one of the offices in her school, there was a colorful alphabet

poster. Tr. at 59. Whenever Mrs. Castaldi took VC to the office, he pointed at the

poster and said the alphabet while pointing at each corresponding letter. Id. She

testified that on May 19, 2006, she had brought VC with her while she cleaned out her

office. She noticed he was “very agitated, upset, inconsolable.” Tr. at 58. When she

took VC past the poster, he stopped, looked at it, and “got really upset and started

crying.” He did not say or point to any of the letters. Tr. at 59.

On cross-examination, Mrs. Castaldi was unable to identify, even vaguely, the

other times when VC had visited her school and recited the alphabet. Tr. at 80. She

indicated that VC could “name” all of the alphabet letters and say his ABCs shortly

before his second birthday (April 2006). She and her husband were working on letters

and letter sounds with their older daughter and “felt that [VC] picked them up because of

that.” Tr. at 81.

Mr. Castaldi’s November 2011 affidavit contradicts some aspects of Mrs.

Castaldi’s testimony. His affidavit indicates that, rather than naming all the alphabet

letters or being able to point them out, VC was “singing typical songs (like the alphabet)

and starting to say his ABCs” prior to May 2006. Pet. Ex. 17 at 700.

In discussing the vision concerns reported to Dr. Escobar in May 2006, Mrs.

Castaldi recalled an incident when she was in the kitchen and VC “came running into

the room and completely missed seeing the kitchen drawer pulled out and ran right into

it.” Tr. at 55. She could not remember any other specific incidents where he ran into

something, but indicated he was bumping into things. Tr. at 55. She also could not

identify the exact date or timeframe of the drawer incident, but placed it prior to the May

8, 2006 visit. Tr. at 78.

During her direct examination, Mrs. Castaldi was questioned about the “several

places in [VC’s] medical chart where [her] history about when [his speech problems]

started is different” than how she testified. Tr. at 62. She explained that when providing

history to providers she did not spend a lot of time with VC’s records in front of her and

was primarily focused on getting him treatment . Tr. at 65. However, on cross

examination, she agreed that, as a speech pathologist, it would be important for

caregivers to provide an accurate history when seeking treatment. Tr. at 86.

11

IV. Untimely Filing.

A. The Statute.

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. . . .”

§ 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, 654 F.3d at 1339. 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.

Because petitioners filed their petition on behalf of VC on May 12, 2009, the first

symptom or manifestation of onset of his autism must have occurred after May 12,

2006, 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.19

The diagnostic criteria found in the Diagnostic and Statistical Manual of Mental

Disorders [“DSM”] have “served as the gold standard for making a clinical diagnosis” of

ASD for more than three decades. C. Johnson, Recognition of Autism Before Age 2

Years, PEDIATRICS IN REVIEW , 29(3): 86-95 (2008), filed as Pet. Ex. 19 and Res. Ex. I

[“Johnson, Pet. Ex. 19”], at 87. The criteria have served as the basis for the

19

I 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.

12

development of numerous developmental exams.20 The screening devices focus on the

different categories of symptoms associated with ASD: deficits in speech and language,

impaired social interaction, and presence of restricted, repetitive patterns of behavior,

interests, or activities. See DSM-IV-TR, filed as Pet. Ex. 20.21 There are no

“pathognomonic clinical signs or confirming laboratory tests” for diagnosing ASD.

Johnson, Pet. Ex. 19, at 86.

Speech delays are often the first symptom of ASD that parents report to their

child’s pediatrician. The parental reports often occur several months after the delays

were first noticed. Johnson and Myers, Res. Ex. H, at 1190. The delayed reporting is

sometimes attributable to parents believing their child is shy or simply a “late-talker.”

Johnson, Pet. Ex. 19, at 91. Some parents also fail to recognize that their child is

reacting to social cues or gestures in addition to, or in place of, spoken words, and thus

overestimate the child’s receptive language abilities. Id.; see also Luyster, Res. Ex. A,

at 1427. Additionally, a child’s echolalia22 is sometimes viewed as functional speech.

However, repeating phrases or reciting nursery rhymes is not the same as having

expressive language. Johnson, Pet. Ex. 19, at 92; see also Johnson and Myers, Res.

Ex. H, at 1192.

Other early symptoms of ASD recognized by parents include exploring toys in

unusual ways and poor motor skills. Normally developing children transition from

sensory-motor play to pretend play around 16 to 18 months, while children with ASD

often continue to mouth, throw, and bang objects and do not advance into pretend play.

Johnson, Pet. Ex. 19, at 89; Johnson and Myers, Res. Ex. H, at 1193. Instead of

pushing a toy car around on the ground, children with ASD will often turn the car over

and spin the wheels. Johnson, Pet. Ex. 19, at 89. Some children will hold objects very

close to their head or look at toys out of the corner of their eyes. Id. at 93. Due to

20

Johnson, Pet. Ex. 19, at 87; see also R. Luyster, et al., Language Assessment and Development in

Toddlers with Autism Spectrum Disorders, J. AUTISM DEV. DISORD., 38: 1426-38 (2008) [“Luyster”], filed as

Res. Ex. A, at 1428-30 (discussing seven of the standard assessment instruments); C. Johnson and S.

Myers, Identification and Evaluation of Children with Autism Spectrum Disorders, Pediatrics, 120: 1183-

1215 (2007), filed as Res. Ex. H [“Johnson and Myers, Res. Ex. H”], at 1200-01 (Table 3: Selected Level

1 and 2 ASD Screening Measures).

21

The DSM-IV-TR has since been replaced by the DSM-V. However, VC was diagnosed based on the

DSM-IV-TR criteria. The symptoms recognized by the medical community at large as those of an ASD

have not changed, but the criteria for diagnosis 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/Pages/Default.aspx (highlighting the differences between DSM-IV and DSM-V).

22

Echolalia has been described as “repeating verbatim what someone else has said. With immediate

echolalia, the child repeats back what has just been said. With delayed echolalia, the child repeats a

phrase, sentence, or even a passage that was previously heard, such as a line from a favorite movie.”

Schum, Pet. Ex. 18, at 706.

13

deficits in social interaction, children with ASD are content to play alone and do not seek

interaction with other children or adults. Johnson, Pet. Ex. 19, at 90.

Although some children with autism appear to have advanced motor skills, others

display subtle deficits in coordination. Johnson, Pet. Ex. 19, at 93; Johnson and Myers,

Res. Ex. H, at 1194. Although not a definitive symptom, motor clumsiness has been

described as a “distinguishing characteristic” of ASD. Johnson and Myers, Res. Ex. H,

at 1194. The Autism Diagnostic Interview Revised (ADI-R), a standard assessment

tool, accounts for loss of motor skills, such as posture, gait, and coordination. A.S.

Meilleur and E. Fombonne, Regression of Language and Non-language Skills in

Pervasive Developmental Disorders, J. INTELLECTUAL DISABILITY RESEARCH, 53(2): 115-

24 (2009), filed as Res. Ex. J, at 119 Table 2 (including loss of motor skills among the

“other skill loss” identified by the ADI-R used in the study).

C. Determining Onset of VC’s Symptoms.

1. Summary of Factual Rulings and Reasons Therefor.

I issued findings of fact, based on the evidentiary record and the testimony of

Mrs. Castaldi and Dr. Escobar at the December 14, 2011 fact hearing. The reasons for

my findings were set forth in detail in my April 26, 2012 Ruling and I incorporate them

herein by reference. In making my findings, I relied extensively on the filed medical

records. I did not find sufficient indicia of reliability in the testimony of Mrs. Castaldi to

credit her testimony over the evidence found in the contemporaneous records. Her

testimony conflicted with histories she provided to various health care providers fairly

closely in time to the events recorded. Additionally, her ability to observe and

accurately recount what she observed is called into serious question by the

incompatibility of her testimony that VC had a 500 word vocabulary at a time when his

pediatrician recorded that he had a “few word” vocabulary, and the fact that she inflated

over time the extent of VC’s vocabulary before his hepatitis A vaccination. Although

petitioners’ counsel attempted to reconcile this discrepancy by arguing an alternate

meaning of “had” in relationship to “vocabulary,” I find the attempt unavailing. In this

regard, Mrs. Castaldi’s training as a speech pathologist is significant, in that such a

professional would be unlikely to use such strained terminology in referring to a child’s

vocabulary skills.

2. Assessing the Medical Records.

The hearing testimony and the parties’ briefs primarily focused on VC’s speech

and language abilities as the initial symptom of his autism. The first documentation of

parental concern regarding VC’s speech is found in the record from his May 23, 2006

ophthalmology appointment, but the record is silent as to when concerns about VC’s

speech first arose. Relying on Mrs. Castaldi’s hearing testimony, and vague references

in their affidavits, petitioners place onset after May 12, 2006 and before the visit to

ophthalmologist Dr. Brown on May 23, 2006, specifically on May 19, 2006. In contrast,

14

relying primarily on the contemporaneous records and the histories provided in non-

contemporaneous medical records from July 2006 onward, respondent contends that

the behavioral symptoms of autism were present, at the latest, by April 14, 2006.

In their May 9, 2012 motion for review, petitioners correctly noted that treating

physicians are often “in the best position to determine factual and medical issues

surrounding vaccination and treatment, including onset of relevant symptoms.”

Petitioners’ Memorandum of Objections at 2 (citing Andreu v. Sec’y, HHS, 569 F.3d

1367 (Fed. Cir. 2009); Zatuchni v. Sec’y, HHS, 69 Fed. Cl. 621 (2006)). However, the

records of treating physicians can be questioned and the weight afforded to them

depends on whether the physician is noting her own observations or merely recording

statements made by the patient. See McKellar v. Sec’y, HHS, 101 Fed. Cl. 297, 304

(2011) (noting that some notations in medical records reflect statements made by the

person being treated and do not signify medical conclusions of the physician); Snyder v.

Sec’y, HHS, 88 Fed. Cl. 706, 745 n.67 (2009) (stressing that a statement of a treating

physician is not “sacrosanct” and can be rebutted).

Thus, although she was VC’s treating physician, Dr. Escobar’s consultation notes

and testimony must be considered alongside the record as a whole, and cannot be

viewed as determinative on the issue of onset, as petitioners alleged in their motion for

review. See Petitioners’ Memorandum of Objections at 3-4. Doctor Escobar testified

that she primarily relied on parental reporting when documenting VC’s speech and

language abilities in her visit notes. Her records are only as reliable as the parental

reporting they are based on, and are less helpful than records from pediatricians who

record the specific words being said by the child or who use developmental screening

tools in a systematic way. Additionally, Dr. Escobar’s May 2006 consultation notes are

internally inconsistent. She described VC as babbling with a few word vocabulary and

also as talking in sentences.

As I noted in my factual findings, the problem with most of the medical histories

in VC’s medical records is that they do not contain the contemporaneous recitation of

symptoms then existing, the type of medical record that I find to be the most reliable.

Additionally, the accuracy of the histories—even those provided closest in time to the

events described—necessarily relies upon the reporter’s ability to observe and

accurately remember. Unfortunately, Mrs. Castaldi’s ability to accurately and

consistently report her observations of VC’s language development is so questionable

that I hesitate to rely upon histories she provided. 23 Nevertheless, the early histories—

those closer in time to the events reported than Mrs. Castaldi’s testimony—do contain

relatively consistent reports.

Although not precisely contemporaneous to the events they describe, I place

substantial importance on the parental statements regarding onset of VC’s speech and

23

The next section highlights the inconsistencies in her reporting.

15

language skills found in the visits to Sooner Start (July 2006), initial neurological

examination with Dr. Hille (November 2006), initial pediatric visit with Dr. Morgan (April

2007) and initial visit with Dr. Koljack (July 2007). This is because one would expect

parents to be as accurate as possible when conveying history about their child during

developmental evaluation or initial consultation by a specialist. The medical histories in

these records place onset of VC’s abnormal speech development in March or April

2006, around the time of his second birthday. See Pet. Exs. 13, p. 598 (“lost a lot of

words in March”); 11, p. 257 (“developmental milestones were progressing normally

until shortly after his [second] birthday”); 7, p. 34 (“normal speech and language

development until just after his second birthday”); 8, p. 52 (mom a speech pathologist

did not notice any problems with his interactive or language skills until around 2 years of

age); 10, p. 103 (“normal child until shortly before second birthday”).

2. Evaluating the Testimony of Mrs. Castaldi.

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, 23 Cl. Ct.

726, 733 (1991) (citation omitted); see also Cucuras v. Sec’y, HHS, 993 F.2d 1525,

1528 (Fed. Cir. 1993) (medical records are generally trustworthy evidence). 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).

a. May 19, 2006 incident.

In my fact ruling, I specifically rejected Mrs. Castaldi’s testimony about the May

19, 2006 incident at her school. The event was alluded to in her May 11, 2009 affidavit,

but not described in any detail until her hearing testimony. It was not mentioned in any

of the histories she provided about VC’s language delay or regression at medical visits

in the summer of 2006, nor, indeed, at any other point in the many medical histories she

provided thereafter, including one in which she asserted that VC previously knew the

alphabet and had a 30 word vocabulary. See Pet. Ex. 11, p. 160.

After arguing in their post hearing brief that the absolute earliest that onset of

loss of language could be flagged was May 19, 2006, noting it was “the very first

incident where [Mrs. Castaldi] thought to herself that something might be wrong” (Pet.

Post Hearing Brief at 1, 4), petitioners downplayed the significance of the event in their

Motion for Review. They acknowledged that it “may not even be a sign or symptom of

anything. Rather than recite the alphabet, the child cried and got upset when he saw

the alphabet poster . . . .” Petitioners’ Memorandum of Objections at 12. They stated

16

that Mrs. Castaldi did not remember “the event until she sat down with [her counsel] and

[they] discussed day by day from May 8, 2006 to May 23, 2006.” Id.

I find it highly unlikely than an attempt over five years later to recall precisely

what happened in a specific week will produce reliable evidence. This is particularly

true when this effort produces testimony about a dramatic event that went unreported

for years, in spite of numerous visits to medical providers investigating VC’s loss of

language.

b. Vocabulary Skills.

In my Ruling, I described Mrs. Castaldi’s account of VC’s vocabulary skills at the

time of his May 2006 vaccination as having grown to a point that strained credulity. I

noted that her testimony differed substantially from the reports of VC’s language abilities

at 2 years of age that appear in the medical records. At the hearing she testified as

follows (Tr. at 52-53):

Q (Mr. Downing): Now, the next couple of sentences seem, at least in my

mind, to be a little contradictory. We have a sentence that

says, "He babbles and has a few-word vocabulary," which is

also mirrored in earlier reports from Dr. Escobar. Then it

says, "He likes to talk in sentences." So can you tell Special

Master Vowell the level of speech development that [VC]

had in May of 2006.

A (Mrs. Castaldi): His vocabulary, I would say, was probably around 500

words. He was speaking in at least three- to four-word

sentences at that point, sometimes longer if the occasion

arose, but consistently probably three- to four-word

sentences.

Nowhere in the medical records was VC reported to have had a vocabulary of

500 words in early May 2006. In their motion for review, petitioners addressed the

discrepancy between Mrs. Castaldi’s hearing testimony and the medical records. They

explained that “there is a significant difference between the number of words known

(words in the vocabulary) versus the number of words the child uses in common

parlance. At two years of age, a normal (emphasis in original) developing child will

have a vocabulary of approximately 300 words.24 However the child will only typically

24

As support for this statement, petitioners cited to a handout found on the website for the Thornapple

Kellogg Schools in Middleville, MI. The handout states that a two year old “has about 300 words in

speaking vocabulary.” http://www.tkschools.org/SiteCollectionDocuments/The%20Two%20Year%

20Old%20Child.pdf at 1 (last visited May 15, 2014). No citation was given for this assertion or the other

developmental skills listed on the document. In contrast, a standard pediatrics textbook indicates that the

typical two year old has a vocabulary of 50 to 100 words and is using three word (subject, verb, object)

17

speak in two word sentences, and even then, likely only uses the same 20 to 30 words

in communicating, mainly names of things, actions, people and situations (i.e., Mom,

Dad, dog, drink, toy).” Petitioners’ Memorandum of Objections at 8.

Petitioners’ explanation for the discrepancy is hampered by the inconsistency of

the extent of VC’s vocabulary in the medical records. If his vocabulary was always

reported as 500 words or 30 words, I could find that VC had an overall vocabulary of

500 words at two years of age, but only routinely used 30 words. However, the reports

regarding his vocabulary at two years of age have grown from a few words, to 30 words,

to 75 words, to 200 words, to the 500 words claimed at the hearing.25 Additionally, it is

noteworthy that petitioners’ reports of VC’s use of multi word sentences in the medical

records each use the term “imitate.”26 This strongly suggests a type of echolalia, rather

than advanced language skills.

3. Evaluating the Experts’ Assertions.

a. Qualifications.

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, 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).

Petitioners’ expert, Dr. Hastings, has a Ph.D. in anatomy as well as a degree in

osteopathic medicine. He is board certified in internal medicine.27 He has past

experience in academics serving as an adjunct associate professor at Baylor College of

Medicine (1992-1993) and a clinical professor and lecturer at the Oklahoma State

phrases. NELSON’S at 32-33; see also Schum, Pet. Ex. 18, at 428 (noting that a typical 18-24 month old

uses 100 to 200 words and combines them in short phrases).

25

Pet. Exs. 11, p. 147 (May 2006, “few word vocabulary); p. 257 (November 2006, “observed a 30 word

vocabulary” before VC regressed in his skills); p. 161 (December 2006, “prior to onset of symptoms [VC]

knew his alphabet and had at least a 30-word vocabulary”); p. 268 (April 2007, “three and four word

sentences reliably and had vocabulary of 75 words”); 10, p. 103 (July 2007, “two to three word sentence

200+ words”); Tr. at 52 (“500 words”).

26

Pet. Exs. 11, p. 217 (On a developmental questionnaire, in response to “Does your child make

sentences that are three or four words long?” Mrs. Castaldi wrote “Was imitating, but also stopped.”); 13,

p. 593 (Sooner Start record indicating that Mrs. Castaldi reported that “at one time [VC] was using words

& imitating 2 word phrases . . . .’).

27

As a D.O., his certification is through the American College of Osteopathic Internists

(https://www.acoi.org) and not through the American Board of Internal Medicine (http://www.abim.org).

18

University College of Osteopathic Medicine (1981-1996), but it is unclear if he has any

current academic appointments. Doctor Hastings’ research and publications seem to

focus on anatomy, hyperlipidemia, and cardiac medicine; he does not appear to have

any publications regarding or expertise in diagnosing or treating autism spectrum

disorders. See generally Curriculum Vitae of Dr. Hastings, filed as Pet. Ex. 16.

In contrast, respondent’s expert, Dr. Max Wiznitzer, specializes in treating

children with autism. He is board certified in three disciplines with a high degree of

relevance to the issues: pediatrics; psychiatry and neurology, with special qualifications

in child neurology; and neurodevelopmental disabilities. Doctor Wiznitzer is an

associate professor of pediatrics, neurology and international health at Case Western

Reserve University, and has hospital appointments in pediatrics and neurology at the

University Hospitals of Cleveland. He previously was the Director of the Rainbow

Autism Center at the Rainbow Babies and Children’s Hospital, also in Cleveland, OH.

Doctor Wiznitzer serves on the editorial boards of several medical journals, and has

authored a number of articles and book chapters about various aspects of autism,

including diagnosis and assessment of the condition. See generally Curriculum Vitae of

Dr. Wiznitzer, filed as Res. Ex. G.

Based on their medical backgrounds, I placed a greater weight on the expert

opinions of Dr. Wiznitzer regarding onset of VC’s autistic symptoms than the opinions of

Dr. Hastings.

b. Doctor Hastings’ Opinions.

Doctor Hastings was retained by petitioners to “provide a medical evaluation

regarding the onset of symptoms of [VC’s] subsequent Autism and its relationship and

temporal framework to his Hepatitis A vaccine of May 8, 2006.” Pet. Ex. 15 at 675. In

particular he was asked to review “the conflicting reports of onset and how encephalitis

may have gotten inserted into the medical chain.” Tr. at 3. Whether as a result of

parental histories so reporting or a misunderstanding as to what petitioners reported to

them, several physicians recorded that VC’s autism symptoms began after a “bout with

encephalitis” in January 2006. Pet. Ex. 15 at 686-92 (referring to records of Drs. Mattox

and Koljack). Doctor Hastings correctly notes that the medical records regarding VC’s

influenza in January-February 2006 do not reflect any encephalitis. Pet. Ex. 15 at 685-

86; Pet. Ex. 11, pp. 144-45).

In his report, filed prior to the hearing and the issuance of my fact ruling, Dr.

Hastings concluded that onset of VC’s ASD symptoms occurred after the May 8, 2006,

vaccination. He stated that “Dr. Escobar’s May 8, 2006 examination findings both

eliminate the January 2006 viral infection as a causative adverse event and confirms

(sic) the absence of and (sic) Autism or Autism like symptoms predating May 8, 2006.”

Pet. Ex. 15 at 693. He summarized Dr. Escobar’s findings as “unequivocally

support[ing] a normal developmental child with normal speech patterns, talking in

sentence, awake, active, alert, and inquisitive and without any of the clinical

19

manifestations of Autism.” Id. His report did not address the other histories provided by

petitioners that conflicted with the history provided at the May 2006 visit and that

describe an earlier onset of speech and language concerns.28

Without explaining why, Dr. Hastings stated that “[w]ithin 8 days following [VC’s]

Hepatitis A Vaccination, [VC] did begin to exhibit outwardly noticeable adversities that

included becoming increasingly irritable, fussy, crying, and the development of a right-

sided weakness.” Pet. Ex. 15 at 677. Eight days after the vaccination is May 16, 2006,

three days earlier than the alleged event at Mrs. Castaldi’s school.

Although petitioners were afforded the opportunity to have an expert address my

findings of fact, petitioners did not submit any supplemental expert report.

c. Doctor Wiznitzer’s Opinions.

Doctor Wiznitzer’s report was submitted after I issued my ruling on facts. He did

not identify any problems with those factual findings. See generally Pet. Ex. F at 6-8.

Based on his review of VC’s medical records, the hearing testimony, and Dr. Hastings’

report, Dr. Wiznitzer concluded that VC displayed “a history of regression of language

skills in March-April 2006.” Pet. Ex. F at 7.

In addition to exhibiting impaired speech and language, Dr. Wiznitzer noted that

VC demonstrated deficits in his motor skills and coordination prior to the May 6, 2006

well child visit. Doctor Wiznitzer opined that VC’s reported visual problems (“being

clumsy, running into things and bumping into things”) “mo[r]e likely than not,

represented an early manifestation of [VC’s] motor incoordination.” Pet. Ex. F at 7. In

his initial neurology evaluation of VC, Dr. Morgan also indicated that VC’s motor and

coordination issues predated his May 8, 2006 well child visit. Pet. Ex. 8, p. 52

(recording that “beginning in [April 2006 VC] began to exhibit some problems with

general incoordination, stumbling about . . . .”). Additionally, Dr. Kukas noted that

petitioners “started noticing periods of clumsiness . . . or unusually tipping back without

falling about the time that [VC’s] regressions started” (Pet. Ex. 11, p. 258) and Dr. Hille

recorded Mrs. Castaldi observation that just after his second birthday VC would often

wake-up jittery and clumsy and that “he would fall down often and bump into things”

(Pet. Ex. 7, p. 34).

Doctor Hastings’ report did not place any significance on, or even mention, the

vision and coordination anomalies described by petitioners in his initial report.

28

As noted in petitioners’ memorandum in support of their motion for review, Dr. Hastings did state in his

report that “[c]ompiled innuendoes based upon erroneous historical inserts and further historical and

erroneous causation conclusion to the onset or causation of this child’s Autism can not be lumped

together in a combined fashion to be used as a basis to deny this child’s legitimate

immunization/vaccination injury.” Pet. Ex. 15 at 694. However, this somewhat incomprehensible

statement was made in relation to the inclusion of encephalitis in VC’s medical records and not

petitioners’ reports of when his impaired speech and language first presented.

20

Petitioners have not filed anything to rebut Dr. Wiznitzer’s pointing to vision issues,

which arose before the allegedly causal vaccination, as a symptom of VC’s

subsequently diagnosed ASD.

D. Applying the Law to the Facts.

Autism cannot be diagnosed by any single abnormal behavior, but by an

accumulation of symptomatic behaviors. 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 first date when diagnosis

would be possible, that triggers the statute of limitations under § 300aa-16(a)(2).”).

I have reviewed the expert opinions submitted by the parties and considered the

arguments advanced by petitioners subsequent to my Ruling, including those put forth

in their Motion for Review, and they do not alter my prior findings regarding when VC

began to exhibit impairments in his communication skills. After reviewing the expert

opinion of Dr. Wiznitzer, I find that VC’s reported vision issues reflect early symptoms of

his autism. Additionally, VC’s lack of reaction to the probable splinter in his foot in

November 2005 (Pet. Ex. 11, pp. 141-42) may also represent an early symptom of his

subsequently diagnosed autism. See Johnson, Pet. Ex. 19, at 93 (stating that children

with ASD “may be indifferent to noxious stimuli and injuries that typically are painful to

others. The dichotomy is puzzling, but it is believed to be due to an abnormal arousal

level or sensory gating system.”).

Because I find that VC exhibited impaired speech and language skills, as well as

deficits in motor skills and coordination and an indifference towards pain, prior to May

12, 2006, this case must be deemed untimely filed.

V. Petitioners’ Theory of Vaccine Causation.

Under the Vaccine Act, the petitioner bears the burden of proving a vaccine-

caused injury. There are two ways causation may be demonstrated. First, a petitioner

may establish a “Table”29 injury. Alternatively, a petitioner may prove that a vaccine

listed on the Table actually caused or significantly aggravated an injury (an “off-Table”

injury). Petitioners in this case have not alleged a Table injury (and no Table injury is

identified for the hepatitis A vaccine), and thus must prove that VC suffered an “off-

Table” injury.

To establish actual causation in an off-Table injury case, a petitioner must show

preponderant evidence of “(1) a medical theory causally connecting the vaccination tand

the injury; (2) a logical sequence of cause and effect showing the vaccination was the

29

See § 11(c)1(C); 42 C.F.R. § 100.3 (2010).

21

reason for the injury; and (3) a showing of a proximate temporal relationship between

the vaccination and injury.” Althen v. Sec’y, HHS, 418 F.3d 1274, 1278 (Fed. Cir.

2005). See §§ 11(c)(1)(C)(ii); 13(a).

Petitioners filed an expert report on December 16, 2009. The report conveys Dr.

Hastings’ general belief that VC’s hepatitis A vaccine caused his autism, but does not

include any specifics concerning the mechanism or causation theory:

[T]he child’s autis[m] Disorder has a temporal relationship to his Hepatitis

A vaccination on May 8, 2006, and the proximal temporal relationship to

his Hepatitis A vaccination and the onset of this Autism disorder

symptoms only occurred following the Hepatitis A administration. We

further confirm there is a medically established sequence of cause and

effect that implicates the vaccine in the development of this child’s Autism.

I would further confirm the cause and effect is in fact logical and medically

supported by the medical records.

Pet. Ex. 15 at 690. The report notes that "[f]urther reports relative to the mechanism of

injury regarding [VC’s] post Hepatitis A vaccination injuries and adverse clinical

outcomes will be the subject of future narrative.” Id. at 675. Although petitioners were

afforded several opportunities to supplement Dr. Hastings’ initial report, no

supplemental report was filed.

I cannot accept Dr. Hastings’ conclusory statements as reliable evidence that the

hepatitis A vaccine can cause autism or that it did so in VC’s case. As the Supreme

Court has noted, a trial court is not required to accept the ipse dixit of any expert’s

medical or scientific opinion, because the “court may conclude that there is simply too

great an analytical gap between the data and the opinion proffered.” Gen. Elec. Co. v.

Joiner, 522 U.S. 136, 146 (1997). I note that there is nothing in Dr. Hastings’ CV that

suggests he has any expertise in the cause or treatment of ASD, and nothing to support

his assertions other than a temporal relationship between vaccination and the first

mention of speech delay to Dr. Escobar. A temporal relationship, standing alone, is

insufficient to prove vaccine causation. Grant v. Sec’y, HHS, 956 F.2d 1144, 1148

(Fed. Cir. 1992).

Despite being afforded several opportunities to do so, petitioners have not put

forth a medical theory causally connecting any vaccination VC received to his

developmental delays and ASD diagnosis. Therefore, petitioners cannot establish they

are entitled to compensation.

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VI. Conclusion.

Because VC exhibited symptoms of autism more than 36 months before Mr. and

Mrs. Castaldi filed this petition on his behalf, this case is untimely filed. Assuming,

arguendo, that it was timely filed, petitioners have failed to put forth a causation theory

that satisfies Althen and therefore are unable to establish that they are entitled to

compensation.

The clerk shall dismiss this case for untimely filing and for failure to

establish entitlement to causation.

IT IS SO ORDERED.

s/Denise K. Vowell

Denise K. Vowell

Chief Special Master

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