Vergara v. Secretary of Health and Human Services

IN THE UNITED STATES COURT OF FEDERAL CLAIMS

OFFICE OF SPECIAL MASTERS

No. 08-882V

Filed: May 15, 2014

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

LUIS VERGARA and JACKELINE *

MORA ANGARITA, parents and natural *

guardians of J.A.V., a minor *

*

Petitioners, * Contemporaneous Records;

v. * Testimony Contradicting

* Records; Autism; Onset;

SECRETARY OF HEALTH * Lack of Factual Predicate for

AND HUMAN SERVICES, * Table Injury Claim

*

Respondent. *

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

Donald M. Gerstein, Esq., Richard Gage, P.C., Cheyenne, WY, for petitioners;

Justine E. Daigneault, Esq., U.S. Dept. of Justice, Washington, DC, for respondent.

RULING ON FACTS1 AND ORDER

Vowell, Chief Special Master:

On December 11, 2008, pro se petitioners Luis Vergara and Jackeline Mora

Angarita [“Mr. Vergara,” “Ms. Mora,”2 or “petitioners”] timely filed a Short-Form Autism

Petition for Vaccine Compensation3 under the National Vaccine Injury Compensation

1

I intend to post this ruling 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). As provided by

Vaccine Rule 18(b), each party has 14 days within which to request redaction “of any information

furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged

or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a

clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the entire decision will be

available to the public.

2

Prior to beginning the hearing, Ms. Jackeline Mora Angarita indicated her preference was to be

addressed as Ms. Mora. Accordingly, I refer to her as Ms. Mora throughout this ruling.

3

By electing to file a Short-Form Autism Petition for Vaccine Compensation, petitioners alleged that:

[a]s a direct result of one or more vaccinations covered under the National Vaccine Injury

Compensation Program, the vaccinee in question has developed a neurodevelopmental

disorder, consisting of an Autism Spectrum Disorder or a similar disorder. This disorder

was caused by a measles-mumps-rubella (MMR) vaccination; by the “thimerosal”

ingredient in certain Diphtheria-Tetanus-Pertussis (DTP), Diphtheria-Tetanus-acellular

Pertussis (DTaP), Hepatitis B, and Hemophilus Influenza Type B (HIB) vaccinations; or

by some combination of the two.

Program, 42 U.S.C. §300aa-10, et seq.4 [the “Vaccine Act” or “Program”], on behalf of

their minor son, J.A.V. By filing a short-form petition, petitioners joined the Omnibus

Autism Proceeding [“OAP”].

The OAP was created to resolve what ultimately totaled about 5700 petitions

alleging that vaccines or the thimerosal preservative contained in some vaccines

caused autism spectrum disorders. In an omnibus proceeding, test cases are selected

for hearing based on the commonality of their causation theory. The parties (other than

those in the test cases selected) are not bound by the results in the test cases, but the

test cases create a body of evidence that can be used to resolve the remaining cases.

In the OAP, three test cases were selected for each of the two theories of vaccine

causation advanced by the petitioners’ bar in the OAP. Hearings were conducted and

decisions issued.5 The decisions in the Theory 1 test cases (which advanced the theory

that the measles, mumps, and rubella [“MMR”] vaccine, either alone or in concert with

thimerosal-containing vaccines caused autism) were appealed; the decisions in the

Theory 2 test cases (that thimerosal-containing vaccines caused autism) were not

appealed. A more detailed explanation of the OAP can be found in Dwyer, 2010 WL

892250, at *2-4.

I. Procedural History.

J.A.V.’s case was filed after the hearings in the test cases began, but before the

decisions were issued. Thus, unlike the early OAP petitioners, Mr. Vegara and Ms.

Mora were required to produce some medical records in order to position J.A.V.’s case

for resolution after the special masters’ decisions were issued in the test cases and

appellate review concluded. See Order, issued Jan. 8, 2009.

When the final appellate decision in the test cases was issued in August, 2010,6

the court began the process of notifying petitioners in the approximately 4800 remaining

OAP cases of the results and asking them how they intended to proceed. When

Autism General Order #1, 2002 WL 31696785 (Fed. Cl. Spec. Mstr. July 3, 2002), Exhibit A, Master

Autism Petition for Vaccine Compensation at 2.

4

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).

5

The Theory 1 cases are Cedillo v. Sec’y, HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr.

Feb. 12, 2009), aff’d, 89 Fed. Cl. 158 (2009), aff’d, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec’y,

HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 473 (2009),

aff’d, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec’y, HHS, No. 01-162V, 2009 WL 332044 (Fed. Cl.

Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009). Petitioners in Snyder did not appeal the

decision of the U.S. Court of Federal Claims. The Theory 2 cases are Dwyer v. Sec’y, HHS, No. 03-

1202V, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); King v. Sec’y, HHS, No. 03-584V, 2010

WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v. Sec’y, HHS, No. 03-215V, 2010 WL 892248

(Fed. Cl. Spec. Mstr. Mar. 12, 2010).

6

Cedillo v. Sec'y, HHS, 617 F.3d 1328 (Fed. Cir. 2010).

2

notified, Mr. Vergara and Ms. Mora indicated that they intended to pursue J.A.V.’s case.

Response, filed Oct. 6, 2010. On October 18, 2010, petitioners were ordered to file a

statement setting forth a theory for how the vaccines J.A.V. received caused his injuries,

as well as all available medical records.

Petitioners filed a statement identifying their theory of causation on November

18, 2010. According to petitioners, J.A.V. developed a vaccine-induced encephalopathy

soon after receiving the MMR vaccine on April 24, 2007, thus implicating the hypothesis

considered and rejected in the Theory 1 test cases. In response to the court’s January

8, 2009 order to produce medical records to position J.A.V.’s case for resolution,

petitioners filed Petitioners’ Exhibits [“Pet. Exs.”] A-D on December 20, 2010.7

This case was reassigned to me on December 21, 2010. On May 23, 2011, I

ordered petitioners to file an expert report by August 10, 2011. On August 15, 2011, I

granted petitioners’ motion for an extension of time until September 26, 2011, to file that

expert report. On September 13, 2011, Mr. Richard Gage entered his appearance on

behalf of petitioners.8 Because Mr. Gage had recently entered his appearance in a

number of OAP cases on behalf of pro se petitioners, I granted the petitioners in this

case additional time to decide how they would proceed. See Order, issued Sept. 19,

2011. I terminated petitioners’ deadline for filing an expert report, and ordered them to

instead file a status report. Id.

In their November 3, 2011 status report, petitioners indicated that they were

attempting to schedule an MRI to provide support for their causation theory in J.A.V.’s

case. Petitioners filed another status report on December 7, 2011, providing their own

background and their plans for prosecuting their case. Mr. Vergara and Ms. Mora

stated that they were medical doctors trained in Colombia where they practiced internal

medicine and pediatrics, respectively. With regard to J.A.V.’s condition, they referenced

a neurology record containing a diagnosis of “encephalopathy.” Status Report, filed

Dec. 7, 2011, at 2 (citing Pet. Ex. C (now Pet. Ex. 3), p. 2). They also asserted that

“their son’s encephalopathy was the result of a vaccination” and that his brain injury

would be shown on a “SPECT” scan.9 Finally, they conveyed that they were attempting

to raise the money to pay for testing and that testing could not be scheduled until the

financial arrangements were made.

7

The convention in the Program is that petitioner’s exhibits are assigned numbers and respondent’s

exhibits are assigned letters. Subsequent petitioners’ exhibits were assigned numbers, beginning with

Pet. Ex. 5. On March 1, 2013, I ordered Exs. A-D redesignated as Petitioners’ Exhibits 1-4.

8

On October 31, 2012, I granted petitioner’s motion to substitute Donald Gerstein for Richard Gage as

counsel of record.

9

A SPECT (single-photon emission computed tomography) scan is a technique used to study regional

cerebral blood flow. It “is particularly useful in investigating cerebral vascular disease in children

(systemic lupus erythematosus) as well as herpes encephalitis, and for localization of focal epileptiform

discharges and recurrent brain tumors.” R. Kliegman, et al., NELSON TEXTBOOK OF PEDIATRICS (18th ed.

2007) at 2442.

3

On December 22, 2011, I ordered petitioners to file an amended petition clearly

explaining their theory of vaccine causation.10 Instead, petitioners filed a status report

on May 2, 2012, expressing their intent to remain in the program and requesting

additional time to raise funds to have a SPECT scan performed. On May 11, 2012,

following a status conference held that day, I ordered petitioners to file the results of the

SPECT scan by July 10, 2012. Petitioners filed J.A.V.’s SPECT scan results (Pet. Ex.

5) on June 21, 2012.

On July 9, 2012, I again ordered petitioners to file an amended petition and an

expert report supporting their theory of causation. Petitioners filed the amended petition

[“Am. Pet.”] on August 23, 2012, in which they alleged that J.A.V. suffered a “Table”

encephalopathy on the evening of April 24, 2007, after having received the diphtheria,

tetanus, and acellular pertussis [“DTaP”],11 MMR, pneumococcal conjugate, hepatitis A,

haemophilus influenzae type b [“Hib”], and varicella vaccines earlier that day. Am. Pet.

at ¶¶ 2-4. Alternatively, petitioners alleged that the vaccines J.A.V. received on April 24,

2007, caused him to suffer an off-Table encephalopathy.12 Am. Pet.at ¶ 5.

On October 9, 2012, petitioners requested a fact hearing to explain what they

observed at the time of J.A.V.’s vaccinations and over the course of the following

months before filing an expert report. Petitioners’ Request for Fact Only Hearing.

Included with petitioners’ request were the affidavits of Mr. Vergara (Pet. Ex. 6) and Ms.

Mora (Pet. Ex. 7). During the hearing, conducted in Miami, Florida, on February 22,

2013, Ms. Mora testified in person. On May 20, 2013, petitioners filed photo and video

evidence as well as transcribed notes from Dr. Jose Vargas. Pet. Exs. 22-35. On June

5, 2013, petitioners filed transcribed notes of Dr. Jose Bengochea. Pet. Ex. 36. My

factual findings are set forth in Section III below.

II. Scope of Ruling and Pertinent Law.

A. Scope of this Ruling.

The record in this case consists of medical records, educational evaluations,

petitioners’ affidavits, videos, and photographs, as well as Ms. Mora’s testimony at the

hearing. According to Mr. Vergara and Ms. Mora, the contemporaneous records

concerning the period shortly after J.A.V.’s April 24, 2007 vaccinations do not detail

10

As I informed petitioners during a status conference on December 7, 2011, the MMR-caused brain

inflammation theory of causation had been considered and rejected in the OAP Theory 1 test cases, and

an amended petition was needed to differentiate J.A.V.’s case from the test cases.

11

There is no evidence that J.A.V. received a DTaP vaccination on April 24, 2007, although he did

receive the other vaccinations listed in the petition on that date. See Pet. Exs. 1, pp. 15-16; 2, p. 98; 4,

pp. 114-15 (vaccination records). J.A.V. received his fourth DTaP vaccination on November 5, 2007, but

this occurred at the same visit when J.A.V. was diagnosed with a developmental language delay and

referred to a neurologist for evaluation. Id.; Pet. Ex. 2, p. 75.

12

Although petitioners do not use the term “off-Table” to describe their alternative theory in their

Amended Petition, their intent to advance an actual causation claim is apparent from context.

4

J.A.V.’s reaction to those vaccinations. Petitioners state that they cared for J.A.V. at

home, using their medical training and experience. Because of the alleged insufficiency

of the record, I conducted a hearing.

In this ruling I determine, to the extent possible without expert testimony, what

transpired following the vaccinations in question. J.A.V. received Table vaccines13 on

April 24, 2007. What is at issue is whether the symptoms, if any, J.A.V. displayed after

these vaccinations are consistent with a Table encephalopathy and when the first

symptoms of what has been diagnosed as an autism spectrum disorder arose. This

requires resolving some conflicts between the contemporaneously created medical

records and later accounts of J.A.V.’s symptoms and condition.

A determination of what actually caused J.A.V.’s injuries will require the

testimony of experts. Therefore, I do not draw any conclusions with regard to what

caused J.A.V.’s symptoms. I note that many of the symptoms J.A.V. displayed are

consistent with the symptoms displayed by other children with autism. If petitioners

intend to pursue an MMR-based causation in fact theory, they will need to produce

evidence not already considered in the context of the Theory 1 test cases, which found

the then-existing evidence of MMR causation to be inadequate.

B. Law Pertinent to Resolving Evidentiary Conflicts.

Conflicts between contemporaneous records and testimony given several years

later at a hearing are common in Vaccine Act cases, and this case is no exception. Two

general legal principles guide the resolution of conflicts between contemporaneous

records and later-adduced evidence. The first is that the absence of a reference to

specific symptoms in a medical record does not conclusively establish the absence of

symptoms during that time frame. See, e.g., Murphy v. Sec’y, HHS, 23 Cl. Ct. 726, 733

(1991), aff’d, 968 F.2d 1226 (Fed. Cir. 1992) (“[T]he absence of a reference to a

condition or circumstance is much less significant than a reference which negates the

existence of the condition or circumstance” (citation omitted)).

The second principle addresses the degree of reliance commonly accorded to

contemporaneous records. 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. at 733 (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.

Reusser v. Sec’y, HHS, 28 Fed. Cl. 516, 523 (1993). Inconsistencies between

testimony and contemporaneous records may be overcome by “clear, cogent, and

13

A Table vaccine is one listed on the Vaccine Injury Table, § 300aa-14(a); 42 C.F.R. § 100.3 (2009).

Only claims pertaining to the listed vaccines are cognizable under the Vaccine Act.

5

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). The following

medical history and the conclusions drawn therefrom are presented with these legal

principles in mind.

C. Credibility Determinations.

Although post vaccination fever and lethargy were not documented in the

medical records, I accept the testimony of Ms. Mora14 regarding what transpired within a

day or two of J.A.V.’s April 24, 2007 vaccinations, as the symptoms of fever and

lethargy J.A.V. displayed were ones commonly occurring after vaccinations.

Furthermore, the parents’ decision to treat J.A.V. at their home rather than seeking

outside medical assistance is logical as both parents have medical degrees and J.A.V.

was their fourth child. Under these circumstances, the absence of any

contemporaneous medical record documenting the fever and lethargy are not

surprising. However, I did not accept testimony and affidavits concerning a possible

seizure event shortly after vaccination, as neither parent witnessed any seizure or

seizure-like activity after vaccination, and Ms. Mora testified that she was speculating

that a seizure had occurred based on J.A.V.’s deterioration over the next several

months.

On several points, primarily involving conflicts between the medical records and

the histories contained therein and the testimony and affidavits of Mr. Vergara and Ms.

Mora, I did not find sufficient indicia of reliability to credit their statements over the

medical record evidence. I considered the length of time that had passed since the

events of late April and early May 2007, to be an important consideration when

evaluating the accuracy of the petitioners’ recollection of events. I note that their

affidavits and statements outside those in the medical records suffer from the same

infirmity. I emphasize that I am not questioning the sincerity of Mr. Vergara and Ms.

Mora. To the contrary, Ms. Mora’s testimony and the affidavits of both parents

appeared to reflect their sincere and honest beliefs about what transpired and when

symptoms arose. I simply found the contemporaneous records, including videos of

J.A.V., to be more reliable.

III. Factual Findings.

A. Facts Not Reasonably Subject to Dispute.

J.A.V.’s medical history before he was 13 months old is not remarkable and is

not a matter in conflict. J.A.V. was delivered prematurely by cesarean section on

January 1, 2006, after 37 weeks of gestation. Pet. Ex. 2, p. 90; Tr. at 10. Although his

14

Although Mr. Vergara did not testify at the February 22, 2013 hearing, he filed a sworn affidavit, Pet.

Ex. 6, on October 9, 2012.

6

Apgar scores were 9 and 9, reflective of a healthy newborn,15 J.A.V. suffered from

several medical problems in the perinatal period and after discharge from the hospital.

Pet. Ex. 2, pp. 90-91; Tr. at 11. Shortly after his birth, J.A.V. was diagnosed with

respiratory distress, suspected sepsis,16 hypocalcemia,17 and jaundice. Pet. Ex. 2,

pp.90-91. Each of these conditions was resolved by the time of his discharge from the

hospital on January 12, 2006. J.A.V. was also diagnosed with hyponatremia18 and

anemia shortly after his birth. Pet. Ex. 2, p. 91. These conditions persisted at the time

of his discharge. Id., p. 92.

J.A.V. had well child checkups on February 2, May 16, June 29, and October 4,

19

2006. Pet. Ex. 2, pp. 78-80, 87. The only problems noted at these well child visits

were a markedly high platelet count from blood drawn after the February 2 visit and

gastroesophageal reflux at the May 16 visit. See Pet. Exs. 2, pp. 80, 87; 33, p. 4. He

also had a high platelet count in May 2006 in blood drawn at one of his sick child visits.

Pet. Ex. 2, p. 82. It does not appear that his pediatrician took any action as the result of

these high platelet counts. J.A.V. was well at the June 29 visit with his reflux resolved.

Pet. Exs. 2, p. 79; 33, p. 5. J.A.V.’s behavior and development were assessed as within

normal limits at his October 4, 2006 well child visit. Pet. Ex. 2, p. 78. J.A.V. did not

have a well child visit at one year of age. Ms. Mora testified that she had no concerns

about J.A.V.’s health in his first year of life. Tr. at 12.

J.A.V. received his first dose of hepatitis B vaccine at the February 2, 2006 visit,

and during subsequent well child visits he received another two doses of hepatitis B,

and three doses of DTaP, polio, Hib, and pneumococcal conjugate vaccines. Pet. Exs.

1, pp. 15-16; 2, p. 98; 4, pp. 114-15. A note from his June 29, 2006 well child visit

indicated that he was behind on his vaccinations due to illness. Pet. Ex. 33, p. 5.

J.A.V. had several sick child visits, primarily for upper respiratory or lung

problems during his first nine months. He was seen for five days of congestion on April

28, 2006, and on examination was afebrile and had chest pain, cough, and wheezing.

15

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.

16

Sepsis is “the presence in the blood or other tissues of pathogenic microorganisms or their toxins.”

DORLAND’S at 1693.

17

Hypocalcemia is low blood calcium. DORLAND’S at 900.

18

Hyponatremia is low blood sodium. DORLAND’S at 903.

19

J.A.V.’s pediatrician was Dr. Jose Vargas. There were problems deciphering a number of his entries in

J.A.V.’s records, and I accordingly ordered petitioners to file a transcription of specific pages of his

records. The transcribed records were filed as Pet. Ex. 33 on May 20, 2013.

7

He was diagnosed with bronchitis20 versus bronchiolitis.21 A chest X-ray performed on

the same day revealed “mild peribronchial thickening.” Pet. Exs. 2, pp. 84-85; 33, p. 1.

On May 1, 2006, he returned with decreased appetite, a cough, and nasal congestion,

and was seen again on May 9, when he had bilateral rhonchi and wheezing and was

diagnosed with bronchiolitis. He was also having some reflux. Pet. Exs. 2, pp. 81, 83;

33, pp. 2-3.

There were no records of health care visits between J.A.V.’s nine month well

child visit on October 4, 2006, and his 15 month well child visit on April 24, 2007 (when

he was nearly 16 months old), at which he received the vaccinations identified in the

petition as causal.22 Based on Ms. Mora’s testimony and the pattern of taking J.A.V. to

his physician when he was acutely ill, I conclude that J.A.V. was a well infant during this

period.23

At the well-child visit on April 24, 2007, Dr. Vargas recorded that J.A.V.’s

developmental history and behavior were within normal limits. J.A.V. had about five

words (“dada,” “nana,” “tete,” and “vala” and one word which even Dr. Vargas could not

decipher when the records were transcribed); however, it is unclear how J.A.V. was

using these words and whether he was currently using all of them. Pet. Exs. 2, p. 77;

33, p. 7; see also Tr. at 14-18 (describing J.A.V. vocabulary at 13 months).

Between this visit and November 4, 2007, J.A.V. was not seen by any health

care provider. His next medical visit was on November 5, 2007. Pet. Ex. 2, p. 75; Tr. at

52.

B. Matters in Conflict.

The matters in conflict appear to be J.A.V.’s symptoms within a few days of the

15 month well child visit, his behavior and symptoms in the next six months, and the

time frame when he lost the use of some words and other symptoms of autism

manifested. With regard to the matters in controversy, I first set forth J.A.V.’s condition

as described in the contemporaneous medical records and in medical histories in these

records, followed by petitioners’ more recent accounts and testimony. These are

followed by my factual findings. I then address in Part C whether J.A.V.’s symptoms

constitute a Table encephalopathy.

20

Bronchitis is “inflammation of a bronchus or bronchi. . . . Symptoms usually include fever, coughing,

and expectoration.” DORLAND’S at 252.

21

Bronchiolitis is “inflammation of the bronchioles, usually occurring in children less than 2 years old and

resulting from a viral infection, particularly with respiratory syncytial virus.” DORLAND’S at 252.

22

J.A.V. received his initial MMR, varicella, and hepatitis A vaccinations at this visit, along with his fourth

doses of Hib and pneumococcal conjugate vaccinations.

23

It is possible that the lack of medical visits during this period was the result of a lack of health

insurance. Mrs. Mora testified that she was without medical insurance from February 2007 through

September 30, 2007. Tr. at 16-17, 34-35.

8

1. Symptoms within a Few Days of Vaccination.

a. Medical Records.

There are no contemporaneous records describing J.A.V.’s condition within a few

days of his April 24, 2007 vaccinations. J.A.V.’s next medical visit did not take place

until November 5, 2007. J.A.V., then 22 months old, was seen for a check-up. Pet. Ex.

2, p. 75; Tr. at 24.

At this visit, Mr. Vergara reported that J.A.V. had been “drooling a lot” and

“doesn’t respond well to his name today.” Pet. Exs. 2, p. 75; 33, p.8; Tr. at 24-25.

Under “Interval History,”24 Dr. Vargas checked “within normal limits” for both

developmental history and behavior. Pet. Exs. 2, p. 75; 33, p. 8. Upon examination, Dr.

Vargas found J.A.V. to be awake, alert, and in no acute distress. He was walking and

running, but not talking. His eye contact was “fair.” He could count “1-2-3,” suggesting

rote counting, rather than an understanding of numbers. Id. Although there is a slight

check mark in the box for normal development at the bottom of the page, Dr. Vargas

placed an “X” in both the boxes for “No” and “Referred” in the normal development box.

Id. His diagnoses were listed as “developmental speech delay” and “well child.” Doctor

Vargas referred J.A.V. to an early intervention program and to a neurologist. Id. During

this visit, J.A.V. received his second hepatitis A, third polio, and fourth DTaP

vaccinations. Id.; Pet. Ex. 1, pp. 15-16.

b. Other Evidence.

In affidavits25 and testimony, Mr. Vergara and Ms. Mora stated that Dr. Vargas

warned them during the April 24, 2007, visit “of possible fever and aches which could be

alleviated with Tylenol.” Pet. Affidavit at ¶ 6; Tr. at 19. According to Ms. Mora, J.A.V.

was quiet and appeared tired during the afternoon of April 24. Tr. at 41.

Around 4-5 PM that day, Ms. Mora took J.A.V.’s temperature and discovered he

had a mild fever. Tr. at 19, 40-41; Pet. Affidavit at ¶ 6. She testified that she and her

husband took J.A.V.’s temperature every five hours and gave him Tylenol every six

hours, but that his fever reached 102° Fahrenheit during the night, at about 1 or 2 AM.

Tr. at 20, 41-43. According to Ms. Mora, when J.A.V.’s fever reached 102°, he was

placed immediately in the bathtub26 with his father for about 20 minutes to avoid a

febrile seizure. Tr. at 20, 42-43; see also Tr. at 50 (Ms. Mora testifying that she and her

husband know that high fevers can cause seizures).

24

An interval history generally encompasses what transpired between the previous medical visit and the

visit at which the history was recorded.

Absent pronouns and references to the other spouse, petitioners’ affidavits are identical. I will refer to

25

Mr. Vergara’s affidavit (Pet. Ex. 6) and Ms. Mora’s affidavit (Pet. Ex. 7) as “Pet. Affidavit.”

26

Petitioners’ affidavits indicate that he was placed in the shower. Pet. Affidavit at ¶6.

9

After the bathtub treatment, J.A.V.’s temperature did not reach 102° again,

although he continued to run a fever for about 20 hours. Tr. at 44. According to Ms.

Mora, J.A.V. displayed malaise and weakness for around 24 hours. Tr. at 20-21,

44;Pet. Affidavit at ¶¶ 6, 7. She noted in her affidavit that he looked “very tired” and “as

though he was in pain and was easily bothered.” Pet. Affidavit at ¶¶ 8, 10. She stated

that she and her husband decided not to take J.A.V. to the hospital when he began to

display symptoms following his vaccinations because, “[a]s parents with medical

backgrounds,” they managed to care for him by controlling his temperature. Pet.

Affidavit at ¶ 7; Tr. at 44-45. She testified that she and her husband did not perceive

the situation to be an emergency “because we didn’t expect anything worse than a fever

and we could control the fever.” Tr. at 53-54.

Ms. Mora and Mr. Vergara now suspect that J.A.V. “may have suffered a partial

seizure that [they] were not aware of” during the first 24 hours after his vaccination. Pet.

Affidavit at ¶ 8. Ms. Mora testified, however, that she did not observe a seizure. Tr. at

52. She added that she did not report that J.A.V. had a seizure at his subsequent

doctor visits because she and her husband did not witness J.A.V. having any seizures.

Tr. at 52-53. Ms. Mora acknowledged during her testimony that J.A.V. has never been

diagnosed with seizures. Tr. at 52. Asked on cross-examination whether she reported

any seizures to Dr. Vargas on November 5, 2007, Ms. Mora answered, “He didn’t have

any seizure.” Id. With regard to J.A.V.’s post-vaccination fever, Ms. Mora stated that

she did not report it to a doctor in November 2007 because “we didn’t think that it was

relevant because we controlled [it].” Tr. at 53.

c. Factual Findings.

(1) Fever.

I find that J.A.V. did have a fever in the 24 hours after his April 24, 2007

vaccinations. Ms. Mora’s testimony with regard to J.A.V.’s fever was clear, cogent, and

internally consistent, and did not appear to be exaggerating what transpired. See Tr. at

19-21, 40-45. Additionally, her testimony was consistent with the statements she and

her husband made in their affidavits. Moreover, her testimony about administering

Tylenol is consistent with the advice commonly given by health care professionals after

administration of vaccinations to treat a post vaccination fever.

Additionally, it is not unreasonable for petitioners to have treated J.A.V.’s fever

without making any report, contemporaneous or otherwise, to his pediatrician. The

fever Ms. Mora described in her testimony was one that was easily treated. As

experienced parents and medical doctors, petitioners knew what treatment to provide.

J.A.V.’s fever peaked at 102° Fahrenheit and did not remain at that level for a prolonged

period of time.

10

(2) Seizure.

I find that J.A.V. did not experience a seizure, febrile or otherwise, after his April

24, 2007 vaccinations. The evidence Ms. Mora and Mr. Vergara offered regarding a

possible “partial or generalized seizure” was speculative, as neither parent witnessed a

seizure. Their speculation appears to be based on J.A.V.’s fatigue, a condition that is

not surprising considering he was feverish and receiving home treatment, including a

bath at 1 or 2 AM. As experienced parents and medical professionals, they would have

sought medical treatment if they truly believed that J.A.V. had experienced a seizure.

At the very least, they would have reported a possible seizure after the development of

the behavioral concerns prompted the November 2007 visit to Dr. Vargas.

It was not until after they conducted internet research concerning the causes of

encephalopathy (see Tr. at 26-27, 29-30, 57-58)—research which likely would have

yielded articles and postings describing the relationship between seizures and

encephalopathy—that Ms. Mora and Mr. Vergara postulated that J.A.V. suffered a

seizure following his vaccinations. I cannot accept their speculation as fact.

2. J.A.V.’s Behavior between April and November 2007.

a. Medical Records.

J.A.V. had no medical visits between the allegedly causal vaccinations and the

November 5, 2007 visit to Dr. Vargas. However, J.A.V. saw several health care

providers from November 2007 through January 2008. At these visits, petitioners had

the opportunity to describe J.A.V.’s symptoms and behavior during the April-November

2007 time frame.

On November 29, 2007, J.A.V. was seen for an initial neurology consultation with

Dr. Kenneth Butler. Pet. Ex. 8, pp. 28-29. Summarizing the history of J.A.V.’s

condition, Dr. Butler noted: “20 [month old male with] lang[uage] delay. Says only 3

words: bye, mama, papa and can count (mama specific). Eye contact was [decreased]

but now better for 2-4 sec[onds]. He socializes and plays [with] sib[lings] and other

children. Knows name sometimes. Understands a few commands: No, name 50%, and

few other commands. Tends to drool a lot. At 13 [months] said mama, agua and other

words and regressed.”27 Pet. Ex. 8, p. 28; see also Tr. at 15.

In recording J.A.V.’s family history, Dr. Butler noted speech delay among J.A.V.’s

brothers. Pet. Ex. 8, p. 28. J.A.V.’s older brother Gabriel did not begin speaking until

2½ years of age. His older brother Luis was also delayed in speech. Another brother,

Raphael, had no speech problems. Id.

27

This entry is ambiguous regarding the time when the regression began, but less than a month later, Dr.

Butler wrote that J.A.V.'s regression "began at 13 months of age." Pet. Ex. 8, p. 31 (Report from Dec. 19,

2007 Video EEG). Ms. Mora testified that, at 13 months of age, J.A.V. said "mama," "water" (in Spanish),

and "moon." Tr. at 15. J.A.V. was 13 months of age in February 2007, before the allegedly causal

vaccinations were administered in April 2007.

11

During his neurological exam, Dr. Butler found J.A.V. to be alert, but with

abnormal speech, comprehension, and social interaction. Pet. Ex. 8, p. 29. His

diagnoses were encephalopathy, language impairment, language regression, and

excessive drooling.28 He also listed “R/O PDD”29 and “R/O Landau Kleffner,”30 which I

interpret as differential diagnoses that he would attempt to “rule out” through testing.

Pet. Ex. 8, p. 29. Doctor Butler ordered a brain MRI,31 a video EEG32, a brainstem

auditory evoked response [“BAER”] test, speech and language therapy, and a follow up

in six weeks. Pet. Ex. 8, p. 29.

The BAER test performed on December 6, 2007, revealed that J.A.V. had normal

hearing in both ears. Pet. Ex. 8, p. 30. The brain MRI performed December 11, 2007,

was also normal. Id., p. 33. On December 19, 2007, a video EEG was performed. Id.,

pp. 31-32. The results were normal, as “no clinical or electrographic events [were]

recorded.” Id., p. 32. In his “Video-EEG Monitoring Report,” Dr. Butler noted that

J.A.V.’s language regression began at 13 months of age, and that he was still “language

impaired.” Id., p. 31.

In December 2007, J.A.V. was evaluated through Florida’s Early Steps

Program.33 This evaluation was subsequently reviewed by members of the Miami-Dade

County Public Schools Office of Special Education and Psychological Services. See

Pet. Exs. 1, pp.19-21; 15.1, pp. 1-3. Testing revealed significant developmental delays

in a number of domains of development, including adaptive, personal-social,

28

Mrs. Mora testified that J.A.V. was not diagnosed with an encephalopathy until May 2008. Tr. at 26.

This record establishes that she was mistaken in her recollection. See Pet. Ex. 8, p. 29.

29

“PDD” likely stands for “pervasive developmental disorder,” the umbrella term used in the DIAGNOSTIC

th

AND STATISTICAL MANUAL OF MENTAL DISORDERS (4 ed.1994) at 65, for the broad category of what are

now termed “autism spectrum disorders” by the DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL

th

DISORDERS (5 ed. 2013) at 31-32, 50-59.

30

Landau-Kleffner Syndrome is a condition that frequently resembles autism spectrum disorders. It is an

acquired epileptic aphasia presenting in childhood. See DORLAND’S at 1836. It can be ruled out by EEG

testing, as it presents with a characteristic pattern of bilateral spikes in the temporal region on EEG. Id.;

see also Pet. Ex. 8, p. 31.

31

A magnetic resonance imaging (MRI) is “a method of visualizing soft tissues of the body by applying an

external magnetic field that makes it possible to distinguish between hydrogen atoms in different

environments.” DORLAND’S at 916.

32

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.

33

Early Steps is run by Florida’s Children’s Medical Services, and is funded by Part C of the Individuals

with Disabilities Education Act (IDEA). Through the program, eligible children can receive early

intervention services. See http://www.mch.com/medical-services/early-steps-southernmost-coast.aspx;

http://www.floridahealth.gov/AlternateSites/CMS-Kids/families/early_steps/early_steps.html (last visited

May 14, 2014).

12

communication, and cognitive. Pet. Ex. 1, pp. 17-18 (results of Battelle Developmental

Inventory (BDI-2) assessment), 25. The school system evaluator noted the reports of

the parents to Early Steps which indicated that J.A.V. “interacts with brothers,” will “say

a word with a prompt” but does “not use spontaneous language,” and “tries to sing

along with TV actions.” Id. at p. 21. The evaluator also noted Dr. Butler’s diagnosis of

PDD. Id.

Asked about their areas of concern, Mr. Vergara and Ms. Mora reported that

J.A.V. “[d]rools a lot when focused on activity but not when humming (listening to

singing) or interactin[g] with others. Reduced eye contact at first which increases with a

desired activity. Uses [own] sign language and grunt patter[n]s but is on a s[ch]edule to

anticipate needs and prevent frustration. He does not point to communicate wants.”

Pet. Ex. 1, p. 24. His parents asked that Early Steps help J.A.V. to use words to

express wants and emotions. Id. Also noted on the intake form was the information

that both parents are now employed, but that Ms. Mora was J.A.V.’s “main caretaker

until 8 months ago.” Id. This would indicate that Ms. Mora returned to work in April or

May of 2007.

Specific findings on evaluation included a significant developmental delay in the

social/emotional sphere and in his receptive and expressive communication. Pet. Ex. 1,

p. 25. His evaluators noted, “J.A.V. shows appropriate affection toward people,

expresses likes or dislikes for certain activities, and is aware of his hands and feet.” Id.

They added, “He does not display independent behavior and did not play peek-a-boo.”

Id. He had a short attention span for his age but was able to “search for a removed

object, attend to an ongoing activity for 15 or more minutes, and place a circle and a

square in a form board.” J.A.V. “played independently and had limited interaction with

the testers.” Id. The Rossetti Infant Toddler Language Scale (RITLS) placed his

receptive language skills at the level of a typical six to nine month old, and his

expressive language skills were solidly at six to nine month old level and scattered at

the level of a typical one year old. Id.

On January 15, 2008, J.A.V. returned to Dr. Butler for a follow up neurology

consultation. Pet. Ex. 8, p. 34. J.A.V. was alert and socially interactive, but had

abnormal speech and comprehension. Id., p. 35. Again, Dr. Butler diagnosed J.A.V.

with encephalopathy and language impairment. He ordered chromosomal microarray34

testing, chromosome analysis, and a Fragile X DNA test.35 Pet. Ex. 8, p. 35. These test

results were normal. Id., pp. 36-40.

34

Microarray refers to “an arrangement of DNA samples, consisting of a set of DNA spots, typically 200

µm or less in diameter, on a substrate; used for automated high-throughput matching of known and

unknown DNA samples. DORLAND’S at 1156.

35

“Fragile sites are regions of chromosomes that show a tendency for separation, breakage, or

attenuation under particular growth conditions. . . . The main clinical manifestations of fragile X syndrome

in affected males are mental retardation, autistic behavior, macro-orchidism, and characteristic facial

features. . . . Diagnosis of fragile X is possible by DNA testing that shows an expansion of a triplet DNA

repeat inside the FMR1 gene on the X chromosome.” R. Kliegman, et al., NELSON TEXTBOOK OF

PEDIATRICS (19th ed. 2011) at 411.

13

b. Other Evidence.

Ms. Mora and Mr. Vergara contend that J.A.V. “changed from being the

precocious, loving and smiley kid to a passive, quiet, and uninterested child” after his

April 24, 2007 vaccinations Pet. Affidavit at ¶ 10; Tr. at 21. They alleged that he “lost

his eye contact, his verbal communication and started drooling.” Pet. Affidavit at ¶ 10;

Tr. at 21, 35. Ms. Mora testified that these behaviors did not appear abruptly, but were

“progressive,” appearing four to five months after J.A.V.’s April 24 vaccinations. Tr. at

22, 35, 53. Ms. Mora stated that she and her husband “didn’t [feel] anything [was

wrong] because you as parents didn’t expect something bad on your child after

vaccination. You’re not expecting more than a regular reaction like fever and that’s it.”

Tr. at 21.

According to Ms. Mora, she and her husband were alerted to J.A.V.’s behavioral

changes by his caretaker, Mrs. Rosa. Tr. at 22; Pet. Affidavit at ¶ 12. Because Ms.

Mora and her husband were working and away from J.A.V. for more than eight hours a

day, they did not notice the changes themselves.36 Tr. at 22, 55-56. On the weekends,

Ms. Mora entertained the children indoors and was not concerned by J.A.V.’s quiet

demeanor because he was engaged in docile activities such as watching television or

playing with toys. Tr. at 67-68. Ms. Mora testified that she would take J.A.V. to daycare

each morning (often while he was still sleeping), pick him up in the evening, give him a

shower, and prepare everything for the next day. Tr. at 22, 35. In September or

October 2007, Mrs. Rosa told them that J.A.V. was “being more quiet than usual” and

“drooling so much” that Mrs. Rosa had to change his clothes a few times a day. Tr. at

22, 24, 34-35, 55; see also Pet. Affidavit at ¶ 11. Ms. Mora added that her own family

also noticed J.A.V.’s unusual behavior, but did not say anything because they didn’t

want to be intrusive. Tr. at 23.

On cross-examination, Ms. Mora was asked about the onset of each of J.A.V.’s

symptoms, which she described as appearing progressively. Concerning J.A.V.’s

cessation of eye contact, she testified that J.A.V. “stopped” making eye contact “in the

first week, two first weeks [after his April vaccinations].” Tr. at 54. She added, however,

that she and her husband “saw it, but [they] didn’t pay any attention to it,” because they

did not expect anything abnormal to occur following vaccinations. Id.

Asked when J.A.V. stopped using words, Ms. Mora testified that J.A.V. “was

talking before [his vaccinations], but [h]e didn’t say any more after that, I’m pretty sure.”

Tr. at 55-56. However, she did not explain why Dr. Vargas recorded that J.A.V. had five

words at the November 2007 visit. Ms. Mora testified that she did not report to Dr.

Butler during J.A.V.’s November 29, 2007 visit that J.A.V. started regressing at 13

months. Tr. at 37. She added, “I don’t know why he put [regressed], but that’s not - -

36

The video and photographic evidence filed on May 20, 2013 indicates petitioners and other family

members had more interaction with J.A.V. after the April 2007 vaccinations than this testimony would

suggest. See Pet. Exs. 23A-H; 28.

14

we report the regression was with Dr. Vargas.” Tr. at 37-38. Asked about the note on

the EEG report indicating that the loss of language occurred at 13 months of age, Ms.

Mora stated, “I don’t know why he put that. Maybe it’s 18 months. I don’t know. I

cannot answer that.” Tr. at 38. She added that the notation could be incorrect. Id.

Ms. Mora testified that, after hearing of J.A.V.’s behaviors and language

problems from Mrs. Rosa, she thought he might have something wrong with his brain.

Tr. at 23. Ms. Mora and Mr. Vergara stated that on a Saturday afternoon they observed

J.A.V.’s drooling and unresponsiveness to his name. Pet. Affidavit at ¶ 14; see also Tr.

at 56-57. It was then that they realized that they “had spent too much time at work and

had not noticed that [their] son could have a problem.” Pet. Affidavit at ¶ 14. After

closely observing J.A.V.’s behavior, Mr. Vergara and Ms. Mora attributed his drooling,

lack of verbal communication, decreased appetite, lethargy, unresponsiveness to

external stimuli, including a lack of eye contact, and generally decreased

consciousness, to an encephalopathy. Id. at ¶ 14. Ms. Mora testified that she became

insured in late-September 2007, and thereafter made an appointment with Dr. Vargas

for November 5, 2007, primarily to address J.A.V.’s excessive drooling.37 Tr. 24, 34-36,

52; Pet. Affidavit at ¶ 15.

The video and photographic evidence suggests that J.A.V.’s excessive drooling

existed before the vaccinations in question, and long before Mrs. Rosa brought it to

petitioners’ attention in September or October 2007. The February 11, 2007 video (Pet.

Ex. 28) shows J.A.V. wearing a bib at a time when he was not eating. Although most of

the photographs in Pet. Ex. 22 that were taken before the April 2007 vaccinations do not

show J.A.V. wearing a bib, Pet. Exs. 23A through 23D, photographs of J.A.V. taken

primarily out-of-doors between May and June 2007, do show him wearing a bib. These

photographs suggest that petitioners were aware of J.A.V.’s excessive drooling prior to

Mrs. Rosa’s report. Additional photographs taken between October 3 and December 9,

2007, also show J.A.V. wearing a bib at times and places when it does not appear that

he was eating. See Pet. Exs. 23E-L.

c. Factual Findings.

(1) Onset of Autistic Behaviors in General.

It is impossible to pinpoint precisely when each of J.A.V.’s autistic behaviors

began. I credit that portion of Ms. Mora’s testimony reflects that these behaviors began

gradually in the four to five months following the vaccinations in April 2007. Gradual

onset is consistent with the manner in which autistic behaviors present in many children,

and would explain why petitioners, who were both experienced parents and medically

37

Ms. Mora likely misspoke when first recounting the events leading to the scheduling of J.A.V.’s

November 5, 2007 doctor visit. She testified that she made an appointment with Dr. Vargas in late-

September 2007, right after she became insured. Tr. at 24, 34-35. She also testified that she did not

become concerned about J.A.V.’s condition until October 2007, after hearing from Mrs. Rosa. Tr. at 22-

24. On cross-examination, however, Ms. Mora testified that she learned of J.A.V.’s behaviors from Mrs.

Rosa in September 2007. Tr. at 36.

15

trained individuals, did not note most of them until their caregiver brought J.A.V.’s

behaviors to their attention. In J.A.V., these behaviors included diminished eye

contact38; words that J.A.V. once used, but used no longer; lack of response to his own

name; and problems in social interaction.

(2) Language Regression.

It is difficult to tell precisely when, if ever, J.A.V. experienced a true language

regression. Although Dr. Vargas used the term “regressed” in November 2007 to

describe the change in J.A.V.’s vocabulary, it is impossible to tell from the records or the

testimony whether J.A.V.’s use of words prior to and after the April vaccinations

constituted a true loss of language.39

The only record that pinpoints precisely when J.A.V. began to lose language

specifies that it happened at 13 months of age. While not precisely contemporaneous,

this record was prepared by a neurologist who was attempting to determine if J.A.V. had

Landau-Kleffner syndrome, and the loss of language and when it occurred could be

significant for that diagnosis. I thus conclude that the evidence preponderates towards

finding a loss of language occurring prior to the allegedly causal vaccinations. In any

event, it is clear that the change in language was not sudden and did not involve a

complete loss of the words he had used at the time of the April 2007 visit. Although

J.A.V. may not have been talking at the November 2007 visit with Dr. Vargas, he was

using at least three words as reported at the November 2007 visit with Dr. Butler.

(3) Unresponsiveness to External Simuli.

I specifically reject petitioners’ testimony regarding J.A.V.’s unresponsiveness to

external stimuli and generally decreased consciousness in the period after J.A.V.’s April

2007 vaccinations. Not only is this testimony unsupported by any medical record, it is

contradicted by petitioners’ contemporaneous statements to health care providers and

the observations of those health care providers as set forth in the medical records.

J.A.V. was described as alert by Dr. Vargas in November 2007. In the Early Steps

evaluation in December 2007, J.A.V. was described as helping with dressing by holding

out his arms or legs, discriminating between familiar and unfamiliar people, physically

exploring his surroundings, playing with toys, and paying attention to music. Pet. Ex. 1,

38

Although Ms. Mora testified that J.A.V. “stopped” making eye contact after the April 2007 vaccinations,

reports to his physicians indicate that it was diminished or decreased. They reported to the school

system that his eye contact was reduced at first but would increase when doing a desired activity.

Moreover, a complete cessation of eye contact is so striking that it would likely prompt even non-

medically trained parents to seek medical advice. I thus conclude that J.A.V.’s eye contact was

diminished, but not entirely absent.

39

Expert testimony provided in other autism cases has indicated that the definition of a true language

regression is more restrictive than simply the loss of a word spoken occasionally. The testimony provided

in this case and in the medical records does not reflect that J.A.V. lost words that he once he used

spontaneously and reliably. I am not concluding that J.A.V. did or did not experience a true language

regression, simply that the evidence is inadequate for me to reach such a conclusion.

16

p. 26. These all demonstrate responsiveness to external stimuli and his environment.

Moreover, had J.A.V. actually displayed unresponsiveness to external stimuli and

decreased consciousness throughout a six to seven month period, I am confident that

such symptoms would have prompted a visit to an emergency room or health care

provider, given the medical training of both parents.

C. Findings regarding a Table Encephalopathy.

1. Requirements for a Table Encephalopathy.

To establish their Table encephalopathy claim, petitioners must demonstrate that

J.A.V. manifested an injury encompassed in the definition of an acute encephalopathy

and that a chronic encephalopathy was present for more than 6 months after the acute

encephalopathy. 42 C.F.R. § 100.3(b)(2).40

For a child younger than 18 months, presenting without an associated seizure

event, an acute encephalopathy is indicated “by a significantly decreased level of

consciousness . . . lasting for at least 24 hours.” § 100.3(b)(2)(i)(A). A significantly

decreased level of consciousness is demonstrated by the presence of one of three

clinical signs for a period of at least 24 hours: “(1) Decreased or absent response to

environment (responds, if at all, only to loud voice or painful stimuli); (2) Decreased or

absent eye contact (does not fix gaze upon family members or other individuals); or (3)

Inconsistent or absent responses to external stimuli (does not recognize familiar people

or things).” § 100.3(b)(2)(i)(D). Sleepiness, irritability (fussiness), high-pitched and

unusual screaming, persistent inconsolable crying, and bulging fontanelle are not,

alone, or in combination, a demonstration of an acute encephalopathy. § 100.3(b)(2)(E).

An acute encephalopathy is an event “that is sufficiently severe so as to require

hospitalization (whether or not hospitalization occurred).”41

2. J.A.V.’s Specific Circumstances.

In April 2007, J.A.V. received only one vaccine with encephalopathy listed as a

Table injury. That was the measles component of his MMR vaccination. According to

the Vaccine Injury Table, the symptoms of a Table encephalopathy must manifest

between five and 15 days after the vaccination. Ms. Mora did not testify to any specific

symptoms arising within this time frame, nor did petitioners’ affidavits address specific

symptoms during this specific time period.

40

See 42 C.F.R. § 100.3(b)(2). The Qualifications and Aids to Interpretation [“QAI”] section of the

Vaccine Injury Table, 42 C.F.R. § 100.3(b), contains definitions for the terms used in the Table. See

Althen v. Sec’y, HHS, 58 Fed. Cl. 270, 280 (2005), aff’d, 418 F.3d 1274 (Fed. Cir. 2005) (noting that the

QAI should be used to interpret key terms found in the Table).

41

§ 100.3(b)(2)(i). When revising the QAI definition it was noted that the hospitalization requirement was

not intended “as an absolute requirement to establish an acute encephalopathy, but rather as an indicator

of the severity of the acute event.” Revision of the Vaccine Injury Table, 60 Fed. Reg. 7685, 7687 (Fed.

20, 1997) (preamble to final rule).

17

Rather, the testimony and affidavits appeared to focus on the first 24 hours after

the April 24, 2007 vaccinations. This may have stemmed from petitioners’ belief that

J.A.V. received a DTaP vaccination in April, as alleged in their amended petition. I find

that J.A.V. did not receive a DTaP vaccination in April 2007.

3. Findings Regarding Table Encephalopathy.

a. Even accepting petitioners’ testimony of the events on the evening of

April 24, 2007, at face value, their descriptions of J.A.V.’s fever and lethargy are

insufficient to constitute an acute encephalopathy as defined by the Vaccine Injury

Table. Not only did these symptoms occur in the wrong time frame after an MMR

vaccination, they were not of the nature and quality required by the Table, as fever and

lethargy alone do not constitute an acute Table encephalopathy.

b. Assuming arguendo that an acute encephalopathy occurred in the

required time frame, J.A.V.’s behavior and symptoms in the six months after the April

2007 vaccinations do not meet the requirements for a chronic encephalopathy. J.A.V.

may not have responded to external stimuli and his environment in the same manner

that he once did, although that is far from well-established by this record, but by

petitioners’ own reports, J.A.V. played with his siblings, ate meals with the family,

enjoying picture books, made some eye contact, and showed affection to family

members. These behaviors are inconsistent with the Vaccine Injury Table’s definition of

a chronic encephalopathy.

c. There is no evidence that the November 2007 vaccinations had any

adverse impact on J.A.V.’s symptoms or behavior.

IV. Conclusion and Orders to the Parties.

Although I have rejected petitioners’ contention that the encephalopathy

referenced in J.A.V.’s medical records constitutes a Table encephalopathy, and have

rejected some of their testimony, I emphasize that I do not think petitioners were

untruthful. Ms. Mora testified forthrightly, based on her best recollections of events that

had occurred many years earlier. Some of her recollections may well have been

colored by the research she has conducted into J.A.V.’s condition in the ensuing years.

Petitioners are competent and caring parents who have engaged in an exhaustive

search for therapies to aid J.A.V. in developing to his fullest potential. They remain

committed to finding the cause of J.A.V.’s condition.

Although I have rejected petitioners’ attempt to establish that J.A.V. suffered a

Table encephalopathy, their actual causation claim remains open. To prevail, they must

produce evidence that one or more of the vaccines that J.A.V. received in April 2007

can cause an autism spectrum disorder, and that they did so in J.A.V.’s case. Because

this case was filed as a part of the OAP, and thus far petitioners have primarily

implicated the MMR vaccine, they must produce evidence not considered during the

Theory 1 test cases. At a minimum, this will require the report of a medical expert.

18

The parties are directed to provide a copy of these factual findings to their

respective experts, and the experts shall conform their expert opinions to these factual

findings. Should an expert disagree with any factual finding herein, that expert shall

clearly state in a supplemental report: (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 causation.

Petitioners shall file their expert report by no later than Monday, July 14,

2014. Respondent shall file her responsive expert report by no later than 60 days

after the filing of petitioners’ expert report. Thereafter, if needed, a causation

hearing will be scheduled.

IT IS SO ORDERED.

s/ Denise K. Vowell

Denise K. Vowell

Chief Special Master

19