# Allen v. Hhs

> United States Court of Federal Claims · October 19, 2015

URL: https://www.frixlaw.com/law-library/cases/3132613

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** October 19, 2015
- **Precedential status:** Published
- **Opinion:** Opinion
- **Judges:** Denise Kathryn Vowell
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/3132613

## How later opinions describe it (automated extraction)

- describing the Daubert factors as an “acceptable evidentiary-gauging tool with respect to persuasiveness of expert testimony already admitted . . . by special masters in vaccine cases”
- holding that scientific evidence and expert opinions must be reliable to be admissible

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 02-1237V
Filed: September 26, 2015
For Publication

********************************
COLLEEN BOSTON MADARIAGA and *
JAMES ALLEN, parents and guardians of *
A.A., a minor, * Measles, Mumps, and
* Rubella [“MMR”] Vaccine;
Petitioners, * Autism; Mitochondrial
* Disorder; Diagnosis;
v. * Metabolic Stress;
* Regression; Treating
SECRETARY OF THE DEPARTMENT * Physicians; Expert
OF HEALTH AND HUMAN SERVICES, * Qualifications
*
Respondent. *
*
********************************

Sylvia Chin-Caplan, Conway, Homer & Chin-Caplan, Boston, MA, for petitioners.
Heather Pearlman, U.S. Dept. of Justice, Washington, D.C., for respondent.

DECISION 1

Vowell, Special Master:

On September 23, 2002, Colleen Allen [“petitioner”] filed a short-form “Petition for
Vaccine Compensation” for compensation under the National Vaccine Injury
Compensation Program, 42 U.S.C. §300aa-10, et seq. 2 [“Vaccine Act” or “Program”] on
behalf of her daughter, A.A. An amended petition, which now constitutes the operative
petition for this claim, was filed on March 1, 2012. 3 On May 9, 2012, petitioner moved

1
The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002) requires
that this decision be publically available. In accordance with Vaccine Rule 18(b), petitioner has 14 days
to identify and move to redact 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 redact such material from public access.
2
The National Vaccine Injury Compensation Program [“Vaccine Program”] is set forth in Part 2 of the
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. § 300aa-10 et seq. (2012). All citations in this decision to individual sections of the Vaccine Act
are to 42 U.S.C. § 300aa.
3
Hereinafter, unless the context clearly indicates otherwise, any reference to “petition” is to this Amended
Petition.
to amend the case caption to reflect her name change following remarriage, and to add
James Allen, A.A.’s father, as a petitioner.

In summary, petitioners claim that the measles, mumps, and rubella [“MMR”]
vaccine A.A. received on October 23, 2000, caused her to suffer from “mitochondrial
pervasive developmental disorder” 4—a “particular form of autistic spectrum disorder
caused by an inborn error of mitochondrial metabolism.” Petition ¶¶ Introduction, 15.
According to their experts, A.A. had an underlying mitochondrial disorder—present
since birth—that made her vulnerable to the inflammatory effects of the MMR vaccine.
The vaccine, which constituted an immunological stressor, overwhelmed A.A.’s already
impaired mitochondrial function and caused extensive cell death in her brain. As a
result of this damage, she experienced an acute regression and ultimately developed
mitochondrial autism. See Petitioners’ Post-Hearing Brief, filed Nov. 27, 2013, at 30-60.

For the reasons set forth below, I find that the record does not contain
preponderant evidence establishing entitlement to compensation.

I. Procedural History.

A. The Omnibus Autism Program [“OAP”].

Beginning in 1997, but peaking numerically in 2002-03, thousands of petitions
were filed alleging either that the measles, mumps, and rubella [“MMR”] vaccine or
thimerosal, an ethyl mercury preservative used in multi-dose vials of vaccine, caused
ASD. The sheer volume of petitions filed—more than 1,300 new petitions in 2002
alone—led to the creation of the OAP. 5 Omnibus programs had been used previously
to make causation determinations in groups of cases alleging that a particular vaccine
caused a specific injury, but the OAP was, by far, the largest such grouping of similar
cases. 6 By filing their original short-form petition, an abbreviated petition authorized by
Autism General Order #1, petitioners opted into the OAP.

Following a series of meetings with an informal advisory committee comprised of
petitioners’ counsel representing many of the Program claimants plus legal and medical
representatives of the Secretary of Health and Human Services, the Office of Special
Masters adopted a plan that would allow a period of discovery, followed by the selection
and litigation of test cases on the theories of causation presented. Autism General

4
Synonymous with “mitochondrial pervasive development disorder” are the terms “autism secondary to
mitochondrial disease” and “mitochondrial autism.” Tr. at 236-37.
5
See Autism General Order #1, issued July 3, 2002 (found at 2002 WL 31696785, 2002 U.S. Claims
LEXIS 365, or http://www.uscfc.uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf) (last
visited on Sept. 8, 2015).
6
See Hennessey v. Sec’y, HHS, No. 01-190V, 2009 WL 1709053 (Fed. Cl. Spec. Mstr. May 29, 2009),
aff’d, 91 Fed. Cl. 126 (2010) (discussing the different types of omnibus proceedings conducted in the
Vaccine Program).

2
Order #1 at 2-3. The conclusions reached on general causation in the test cases would
be used to resolve the remaining individual claims. Id. at 3. Petitioners were allowed to
“opt in” or “opt out” of the proceedings and future claimants could automatically “opt in”
by filing the short form petition included as Attachment B to Autism General Order #1.
Autism General Order #1 at 6-8.

Attorneys representing petitioners created the Petitioners’ Steering Committee
[“PSC”] to coordinate the OAP litigative effort. The PSC acknowledged that there was
insufficient evidence at the time the OAP was created to prove vaccine causation, but
averred that such evidence could be found through discovery and ongoing scientific
investigations. Petitioners sought and received an extended period of time to conduct
discovery and prepare to litigate test cases.

Nearly five years after the OAP was created, litigation in the test cases began.
The PSC presented two different theories on the causation of ASD in two sets of test
cases. The first alleged that thimerosal-containing vaccines and the MMR vaccine, in
combination, could cause ASD (Theory 1). The second alleged that thimerosal-
containing vaccines could cause ASD (Theory 2). 7

Decisions in each of the three Theory 1 test cases, which were tried in 2007,
rejected petitioners’ causation theories. 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). 8

Decisions in the three Theory 2 test cases, which were tried in 2008, also
rejected the causation theory presented. Petitioners did not seek review of the special
masters’ decisions. Dwyer, 2010 WL 892250; King v. Sec’y, HHS, No. 03-584V, 2010
WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead, 2010 WL 892248.

An impressive body of medical and scientific evidence was adduced in the OAP
test cases, with the three special masters who heard this evidence finding that the issue
of vaccine causation was “not a close case.” See, e.g., King, 2010 WL 892296, at *90
(emphasis in original); Snyder, 2009 WL 332044, at *198. Each of the three special
7
A detailed discussion of the OAP can be found at Dwyer v. Sec’y, HHS, No. 03-1202V, 2010 WL
892250, at *2 (Fed. Cl. Spec. Mstr. Mar. 12, 2010). In keeping with the intent that the OAP test case
evidence be available to aid in resolving the remaining OAP cases, the evidence (including expert
reports, transcripts of testimony, trial presentation materials (trial exhibits), and lists of the medical
journals and other documents filed by the parties) is posted on the Court of Federal Claims website
(http://www.uscfc.uscourts.gov/docket-omnibus-autism-proceeding) (last visited on May 11, 2015). The
parties in the test case hearings all filed explicit written consent to make these materials publicly
available. See, e.g., Mead v. Sec’y, HHS, No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12,
2010), at *1 n.1 (referencing petitioners’ and respondent’s written consent in that case).
8
Petitioners did not appeal the Court of Federal Claims decision in Snyder to the Federal Circuit.

3
masters independently determined that the medical theories advanced were not reliable
and that the test case petitioners had failed to produce preponderant evidence of
causation. The OAP test case litigation concluded in 2010, with the last Federal Circuit
decision affirming the dismissal of the final Theory 1 test case. 9

During the period between the test case hearings and the final appellate action
on the test case decisions, petitioners in this case, like others in the OAP, were ordered
to file the medical records necessary to establish that the petition was timely filed. See
Order, issued Mar. 13, 2009, at 5. Petitioners filed the required medical records on
June 11, 2009 and July 22, 2009. See Petitioners’ Exhibits [“Pet. Exs.”] 1-10. On
August 14, 2009, respondent filed a statement indicating that the claim was timely filed
and involved a diagnosis of ASD. Because the claim was determined to have been
timely filed, petitioners were ordered to file all remaining medical records. See Order,
issued Aug. 24, 2009, at 1-2. Petitioners filed the required medical records on
November 19, 2009 and December 23, 2009. See Pet. Exs. 11-14.

With appellate review completed, orders were issued on a rolling basis to the
remaining 4,800 petitioners, requiring them to inform the court whether they intended to
dismiss their case or proceed on a different theory or with different evidence.
Petitioners were ordered to inform the court if they wished to proceed with their claim.
See Order, issued May 12, 2011, at 3. If petitioners wished to continue with their claim,
they were ordered to file an amended petition, setting forth their theory of causation. 10
Id. During the next ten months, petitioners filed additional medical records. See Pet.
Exs. 15-20. On March 1, 2012, they filed their amended petition.

B. Procedural History Post-OAP.

On March 15, 2012, I held a telephonic status conference to discuss petitioners’
amended petition and next steps in this case. I ordered petitioners to file any
outstanding medical records and a supplemental statement of completion by March 30,
2012, and expert reports by May 14, 2012. See Scheduling Order, issued Mar. 15,
2012.

On March 30, 2012, petitioners filed a supplemental statement of completion
indicating that they had filed all of the medical records to substantiate the amended
petition.

After requesting and receiving additional time to file their expert reports (see
Motions, filed May 14, 2012; July 16, 2012), petitioners filed an expert report, curriculum
vitae [“CV”], and two supporting documents from Dr. Richard Kelley; and an expert
report, CV, and one article from Dr. Andrew Zimmerman on July 19, 2012. See Pet.
9
Cedillo v. Sec’y, HHS, 617 F.3d 1328 (Fed. Cir. 2010).
10
Petitioners were cautioned that the special masters did not intend to re-litigate the test case theories,
and that a reasonable basis to proceed would require either new evidence on the old theories or new
theories of causation. See Order, issued May 12, 2011, at 2.

4
Exs. 23-26. 11 Although both experts treated A.A., they did so long after onset of her
ASD symptoms.

On November 16, 2012, respondent filed her supplemental Rule 4(c) report; an
expert report, CV, and eight articles from Dr. Stephen Cederbaum; and an expert report,
CV, and seven articles from Dr. Max Wiznitzer, after seeking one extension of time.
See Respondent’s Rule 4(c) report; Respondent’s Exhibits [“Res. Exs.”] A-S.

On January 9, 2013, I held a telephonic status conference pursuant to Vaccine
Rule 5 12 to discuss the expert reports and positions of the parties. During the status
conference, the parties agreed that the case was ready for a hearing to address the
experts’ disagreement with regard to causation. I noted that certain factual disputes still
existed and that I would need the experts to testify on these issues as well. I ordered
the parties to file a joint status report by January 24, 2013, providing possible hearing
dates. See Scheduling Order, issued Jan. 9, 2013.

After the parties filed their joint status report, I scheduled a four-day entitlement
hearing in Washington, D.C. from July 9-12, 2013. See Pre-Hearing Order, issued Jan.
28, 2013. On April 5, 2013, I ordered the parties to file any outstanding evidence on
which they intended to rely by May 24, 2013. See Pre-Hearing Order, issued Apr. 5,
2013, at 1. I also ordered the parties to file (1) a joint submission identifying any
disputed and non-disputed issues; (2) a memorandum containing their basic factual
contentions and applicable legal authority; (3) an affidavit from each fact witness, if not
previously filed; and (4) witness lists. Id. at 2.

Over the next several months, petitioners timely filed additional medical
literature, 13 updated school and medical records, and relevant video evidence.
Respondent also filed additional medical literature. 14 On June 10, 2013, the parties filed
their pre-hearing submissions. Petitioners indicated that they would be calling four
witnesses, including two expert witnesses, to testify at the hearing. See Pet. Pre-
Hearing Submission, filed June 10, 2013, at 34. Respondent indicated that she would
be calling both of her expert witnesses to testify. See Res. Pre-Hearing Submission,
filed June 10, 2013 (ECF No. 80), at 16. Petitioners also filed the affidavits of James
Allen (A.A.’s father) and Susan Edick (A.A.’s aunt), A.A.’s vaccination record, and
additional video and photographic evidence.

11
The supporting documents from Dr. Kelley included A.A.’s amino acid profile (Pet. Ex. 23A) and an
unpublished protocol titled “Evaluation and Treatment of Patients with Autism and Mitochondrial Disease
(Pet. Ex. 23B). Doctor Zimmerman submitted J. Poling, et al., Developmental Regression and
Mitochondrial Dysfunction In a Child with Autism, J. CHILD NEUROL., 21 (2): 170-72 (2006), filed as Pet.
Ex. 25, Tab A [hereinafter “Poling, Pet. Ex. 25A”].
12
RCFC, Appendix B.
13
See Pet. Exs. 27-59, 65-74.
14
See Res. Exs. T-CC.

5
Finally, the parties filed a joint submission identifying the disputed and non-
disputed issues. See Joint Pre-Hearing Submission, filed June 10, 2013 (ECF No. 79).
Specifically, the parties disputed (1) “the state of A.A.’s health and development prior to
October 23, 2000”; (2) whether “A.A. suffer[ed] a developmental regression after her
receipt of the October 23, 2000, MMR vaccination[,]” and, if so, when the regression
occurred; (3) whether the “October 23, 2000, MMR vaccinations cause[d]-in-fact any of
A.A.’s subsequently diagnosed developmental, neurological, or mitochondrial issues”;
and (4) whether “A.A. has a mitochondrial disease[.]” Id. at 1-2.

On June 20, 2013, petitioners filed additional video evidence. See Pet. Ex. 80.
On June 28, 2013, I held a telephonic status conference with the parties to discuss the
pending hearing. I also discussed the video evidence filed by petitioners. Petitioners’
counsel confirmed that the video was a compilation of clips taken from a more complete
recording. I explained that although the edited clips could be used during testimony, the
entire recording should be filed into the record for review. I also requested that any
additional videos of A.A. from the first two years of her life be filed, if available. See
Scheduling Order, issued July 1, 2013.

In compliance with my order, petitioners filed an unedited version of the video.
See Pet. Ex. 81. Petitioners also filed a status report stating that “after a diligent
search, . . . they were unable to locate any additional videos of A.A. from one to two
years of age.” See Status Report, filed July 2, 2013, at 2.

The entitlement hearing was held as scheduled, from July 9-12, 2013. Four
physicians testified at the four day hearing. Mr. Allen and Ms. Edick also testified in
person. A.A. also attended part of the hearing, and I had the opportunity to meet and
speak with her. Following the hearing, I set a schedule for the identification and
correction of transcript errors and the submission of post-hearing briefs. See Post-
Hearing Order, issued on July 30, 2013.

On August 1, 2013, petitioners filed several exhibits used during the hearing.
See Trial Exhibits [“Trial Exs.”] 1-5. On September 3, 2013, I filed Court Exhibit I, a
medical journal article, and provided the parties and their experts an opportunity to
comment on the exhibit. See Res. Resp. to Court’s Sept. 3, 2013 Order and Ex., filed
Sept. 30, 2013; Res. Ex. DD; Pet. Resp. to Court’s Sept. 3, 2013 Order and Ex., filed
Oct. 3, 2013; Pet. Ex. 82.

On September 6, 2013, the parties submitted their joint corrections to the
transcript. A corrected version of the transcript was filed on September 19, 2013. 15

Simultaneous post-hearing briefs were filed on November 27, 2013. On
December 12, 2013, the parties submitted responses to the post-hearing briefs,
completing the record.

15
All references to the transcript are to the corrected version.

6
II. Legal Standards Applying to Off-Table Causation Claims.

When petitioners allege an off-Table injury, eligibility for compensation is
established when, by a preponderance of the evidence, petitioners demonstrate that the
vaccinee received, in the United States, a vaccine appearing on the Table and
sustained an illness, disability, injury, or condition caused by the vaccine or experienced
a significant aggravation of a preexisting condition. They must also demonstrate that
the condition has persisted for more than six months. 16 Vaccine Act litigation rarely
concerns whether the vaccine appears on the Table, the geographical location of
administration, or whether the symptoms have persisted for the requisite time. Rather,
in the very small minority of Vaccine Act cases that proceed to a hearing, the most
common issue to be resolved by the special master is whether the injury alleged was
caused by the vaccine.

To establish legal causation in an off-Table case, Vaccine Act petitioners must
establish by preponderant evidence: (1) a reliable medical theory causally connecting
the vaccination and the injury; (2) a logical sequence of cause and effect showing that
the vaccination was the reason for the injury; and (3) a proximate temporal relationship
between vaccination and injury. Althen v. Sec’y, HHS, 418 F.3d 1274, 1278 (Fed. Cir.
2005); see de Bazan v. Sec’y, HHS, 539 F.3d 1347, 1351-52 (Fed. Cir. 2008); Caves v.
Sec’y, HHS, 100 Fed. Cl. 119, 132 (2011), aff’d per curiam, 463 Fed. Appx. 932 (Fed.
Cir. 2012) (specifying that each Althen factor must be established by preponderant
evidence). The applicable level of proof is the “traditional tort standard of ‘preponderant
evidence.’” Moberly v. Sec’y, HHS, 592 F.3d 1315, 1322 (Fed. Cir. 2010) (citing de
Bazan, 539 F.3d at 1351); Pafford v. Sec’y, HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006);
Capizzano v. Sec’y, HHS, 440 F.3d 1317, 1320 (Fed. Cir. 2006); Althen, 418 F.3d at
1278). Although special masters are not bound by the formal rules of evidence
generally applicable in federal courts, they are required to find evidence reliable before
they may consider it. Knudsen v. Sec’y, HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994)
(Petitioner has the burden to present a reliable and reputable medical theory, which
must be “legally probable, not medically or scientifically certain.”); Daubert v. Merrell
Dow Pharmaceuticals, 509 U.S. 579, 590 (1993) (holding that scientific evidence and
expert opinions must be reliable to be admissible). The preponderance standard
“requires the trier of fact to believe that the existence of a fact is more probable than its
nonexistence.” In re Winship, 397 U.S. 358, 371 (1970) (Harlan, J., concurring)
(internal quotation and citation omitted).

Another formulation of the causation requirement in off-Table cases is the “Can it
cause?” and “Did it cause?” inquiries used in toxic tort litigation. These queries are also
referred to as issues of general and specific causation. Prong 1 of Althen has been
characterized as an alternative formulation of the “Can it cause?” or general causation
query. Prong 2 of Althen, the requirement for a logical sequence of cause and effect

16
Section 13(a)(1)(A). This section provides that petitioner must demonstrate “by a preponderance of the
evidence the matters required in the petition by section 300aa–11(c)(1) . . . .” Section 11(c)(1) contains
the factors listed above, along with others not relevant to this case.

7
between the vaccine and the injury, has been characterized as addressing the “Did it
cause?” or specific causation query. See Pafford v. Sec’y, HHS, No. 01-165V, 2004 WL
1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19 (2005), aff’d,
451 F.3d 1352 (2006). Prong 3 of Althen, the requirement that the injury sustained
occur within a medically appropriate interval after vaccination, is subsumed into the
other inquiries. Even if a particular vaccine has been causally associated with an injury,
petitioner must still establish facts and circumstances that make it more likely than not
that this vaccine caused the particular injury. Timing may be one of those
circumstances.

Whether a case is analyzed under Althen or the “Can it cause?” formulation,
petitioners are not required to establish identification and proof of specific biological
mechanisms, as “the purpose of the Vaccine Act’s preponderance standard is to allow
the finding of causation in a field bereft of complete and direct proof of how vaccines
affect the human body.” Althen, 418 F.3d at 1280. Petitioners need not show that the
vaccination was the sole cause, or even the predominant cause, of the injury or
condition; showing that the vaccination was a “substantial factor” 17 in causing the
condition, and was a “but for” cause, are sufficient for recovery. Shyface v. Sec’y, HHS,
165 F.3d 1344, 1352 (Fed. Cir. 1999); see also Pafford, 451 F.3d at 1355 (petitioners
must establish that a vaccination was a substantial factor and that harm would not have
occurred in the absence of vaccination). Petitioners cannot be required to show
“epidemiologic studies, rechallenge, the presence of pathological markers or genetic
disposition, or general acceptance in the scientific or medical communities to establish a
logical sequence of cause and effect,” Capizzano, 440 F.3d at 1325, but the special
master may certainly consider such evidence when filed. Andreu v. Sec’y, HHS, 569
F.3d 1367, 1379 (Fed. Cir. 2009) (Special masters may consider medical literature and
epidemiological evidence, when it is submitted, in “reaching an informed judgment as to
whether a particular vaccine likely caused a particular injury.”). Causation is determined
on a case by case basis, with “no hard and fast per se scientific or medical rules.”
Knudsen, 35 F.3d at 548 (Fed. Cir. 1994). Close calls regarding causation must be
resolved in favor of petitioners. Althen, 418 F.3d at 1280; but see Knudsen, 35 F.3d at
550 (when evidence is in equipoise, the party with the burden of proof fails to meet that
burden).

In Vaccine Act cases, special masters are frequently confronted by expert
witnesses with diametrically opposing positions on causation. When experts disagree,
many factors influence a factfinder to accept some testimony and reject other contrary
testimony. As the Federal Circuit noted, “[a]ssessments as to the reliability of expert
testimony often turn on credibility determinations, particularly in cases . . . where there
is little supporting evidence for the expert’s opinion.” Moberly, 592 F.3d at 1325-26.
17
The Restatement (Third) of Torts has eliminated “substantial factor” in the factual cause analysis. § 26
cmt. j (2010). Because the Federal Circuit has held that the causation analysis in the Restatement
(Second) of Torts applies to off-Table Vaccine Act cases (see Walther v. Sec’y, HHS, 485 F.3d 1146,
1151 (Fed. Cir. 2007); Shyface, 165 F.3d at 1352), this change does not affect the determination of legal
cause in Vaccine Act cases: whether the vaccination is a “substantial factor” is still a consideration in
determining whether it is the legal cause of an injury.

8
Objective factors, including the qualifications, training, and experience of the expert
witnesses; the extent to which their proffered opinions are supported by reliable medical
research and other testimony; and the factual basis for their opinions are all significant
factors in determining what testimony to credit and what to reject. Lalonde v. Sec’y,
HHS, 746 F.3d 1334, 1340 (Fed. Cir. 2014) (noting that “as the finder of fact, the special
master was responsible for assessing the reliability of [the expert’s] testimony by looking
for reliable medical or scientific support” (citing Moberly, 592 F.3d at 1324-25)).

Congress contemplated that special masters would weigh and evaluate opposing
expert opinions in determining whether petitioners have met their burden of proof.
Congress clearly specified petitioners’ burden of proof in off-Table cases as the
preponderance of the evidence standard. It directed special masters to consider the
evidence as a whole, but stated that special masters are not bound by any particular
piece of evidence contained in the record. 18 In weighing and evaluating expert opinions
in Vaccine Act cases, the same factors the Supreme Court has considered important in
determining their admissibility provide the weights and counterweights. See Kumho
Tire Co. v. Carmichael, 526 U.S. 137, 149-50 (1999); Terran v. Sec’y, HHS, 195 F.3d
1302, 1316 (Fed. Cir. 1999). 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).

Although the Federal Rules of Evidence and cases interpreting them are not
binding on special masters, they can guide their decisions. Daubert, which interpreted
Rule 702 of the Federal Rules of Evidence, provides a useful framework for evaluating
scientific evidence in Program cases. Terran, 195 F.3d at 1316 (concluding that it was
reasonable for the special master to use Daubert to evaluate the reliability of an expert’s
testimony); Cedillo, 617 F.3d at 1339 (noting that special masters are to consider all
relevant and reliable evidence filed in a case and may use Daubert factors in their
evaluation of expert testimony); Davis v. Sec’y, HHS, 94 Fed. Cl. 53, 67 (2010)
(describing the Daubert factors as an “acceptable evidentiary-gauging tool with respect
to persuasiveness of expert testimony already admitted . . . by special masters in
vaccine cases”); see also Snyder, 88 Fed. Cl. 706, 718 (2009) (quoting Ryman v. Sec’y,
HHS, 65 Fed. Cl. 35, 40-41 (2005) (special masters perform gatekeeping function when
determining “whether a particular petitioner’s expert medical testimony supporting
biological probability may be admitted or credited or otherwise relied upon” and as a
“trier-of-fact [a special master] may properly consider the credibility and applicability of
medical theories”)). The special master’s use of the Daubert factors to evaluate the
reliability of expert opinions in Vaccine Act cases has been cited with approval by the
Federal Circuit more recently in Andreu, 569 F.3d at 1379 and Moberly, 592 F.3d at
1324. See also Vaughan v. Sec’y, HHS, 107 Fed. Cl. 212, 222 (2012) (“The Federal
18
See § 13(a)(1)(A) (preponderance standard); § 13(a)(1) (“Compensation shall be awarded . . . if the
special master or court finds on the record as a whole . . . .” ); § 13(b)(1) (indicating that the court or
special master shall consider the entire record in determining if petitioner is entitled to compensation and
special master is not bound by any “diagnosis, conclusion, judgment, test result, report, or summary”
contained in the record).

9
Circuit has repeatedly stated that the Special Master may refer to Daubert to assess
reliability of expert testimony in vaccine cases.”). Special masters decide questions of
credibility, plausibility, probability, and reliability, and ultimately determine to which side
the balance of the evidence is tipped. See Pafford, 451 F.3d at 1359.

Bearing all these legal standards in mind, I now turn to the evidence presented in
this case.

III. Summary of Relevant Medical Records.

A. Early Medical and Developmental History.

A.A., petitioners’ first child, was born in mid-July, 1999. She was a healthy
newborn, with Apgar scores of 8 and 9. 19 Pet. Ex. 1, p. 19. Her newborn exam was
normal. 20 Pet. Ex. 3, pp. 5, 16.

During her first year of life, A.A. received routine childhood immunizations 21 and
was generally healthy with no major illnesses. Her medical records from Countryside
Pediatrics [“Countryside”], her primary care provider, 22 reflect scheduled well child
examinations, as well as periodic unscheduled visits due to minor illnesses.

A.A. was seen for her two-month well child visit on September 17, 1999, and was
noted to be “doing very well.” Pet. Ex. 9, p. 13. The medical report indicated a normal
physical examination, and normal development as measured by six defined skills,
including whether she regarded a face directly and responded to sound. 23
19
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 (32d ed. 2012)
[“DORLAND’S”] at 1682; NELSON TEXTBOOK OF PEDIATRICS (19th ed. 2011) [“NELSON’S ”] at 536-37.
20
She initially failed the audiological evaluation; however, upon re-testing, her hearing was found to be
within normal limits. Pet. Ex. 3, pp. 13-15.
21
On September 17, 1999, A.A received her first vaccinations, which included the combined diphtheria,
tetanus, and acellular pertussis [“DTaP”]; Haemophilus influenzae Type b [“Hib”]; and the inactivated polio
[“IPV”] vaccines. Pet. Ex. 9, p.1. She received the second round of the same vaccines at her two month
well child visit on November 19, 1999. Id. She received her third DTaP and Hib vaccines at her six
month well child visit on January 21, 2000. Id. She received the varicella and her first hepatitis B
vaccines at her one year well child visit on July 26, 2000. Id.
22
A.A. was evaluated by a variety of health care professionals at Countryside Pediatrics, including
medical doctors, certified pediatric nurse practitioners, and registered nurses. These professionals will all
be referred to as her “pediatrician,” regardless of their credentials.
23
A.A.’s pediatrician made use of developmental checklists with very specific developmental milestones
for specific ages. Those for the two month visit incuded: (1) Regards face directly; (2) Lifts head when
upright; (3) Coos; (4) Smiles; (5) Grasps object when placed in hands; (6) Responds to sound. Pet. Ex.
9, p. 13.

10
On November 11, 1999, at about four months of age, she was seen for an upper
respiratory infection [“URI”]. Pet. Ex. 9, p. 62. She had awakened screaming, with
fever, irritability, and loss of appetite. Id. Her pediatrician gave instructions to call if her
fever exceeded 100 degrees or if she did not improve within three days. Id. On
November 16, 1999, she was seen due to congestion, irritability, and difficulty sleeping,
and was diagnosed with bronchiolitis. Id., p. 61. She returned again on November 19,
1999, with URI symptoms and continued congestion. Id., p. 60.

At her six-month well child visit on January 21, 2000, A.A.’s growth and
development were normal. Pet. Ex. 9, p. 12. The medical report indicated a normal
physical examination, and normal development as measured by eight defined skills,
including whether she laughed and babbled or could sit with little support. 24 Id. On
January 26, 2000, she returned due to a persistent cough and runny nose, which was
diagnosed as a URI. Id., p. 59. She had been pulling at her ears, as well. Id.

A.A. was seen for her nine-month well child visit on April 21, 2000. Pet. Ex. 9, p.
11. The medical report contained no written comments, but indicated a normal physical
examination, and normal development as measured by seven defined skills, including
the ability to imitate “mama, dada.” 25 Id. On April 26, 2000, A.A. returned due to
congestion and a raspy voice. Id., p. 58. After examination, she was diagnosed with
right otitis media [“OM”], bilateral conjunctivitis, and a URI. Id.

On July 24, 2000, A.A. attended her one-year well child examination,
accompanied by her nanny. She was assessed as normal with regard to illness and
accidents, and her temperament, as reported by the nanny, was “no problem.” The
corresponding medical report indicated a normal physical examination, and normal
development as measured by eight defined skills, including whether she could walk two
to three steps or say one to three words. 26 Pet. Ex. 9, p. 10.

B. Administration of Allegedly Causal Vaccination.

As reflected by the medical evidence of record, A.A. did not visit any healthcare
provider between her one-year well child visit and her 15-month checkup. At that
examination, on October 23, 2000, she was tugging at her ears and was reported to
often have a cold. Pet. Ex. 9, p. 9. Her physical examination was normal, although her
tympanic membranes had fluid. Id. She also had normal development as measured by

24
The eight assessed developmental skills were: (1) Reaches for toys; (2) No head lag; (3) Laughs,
babbles; (4) Peak-a-boo, pat-a-cake; (5) Sits with little support; (6) Fearful of strangers; (7) Rolls over; (8)
Bears own weight. Pet. Ex. 9, p. 12.
25
The seven assessed developmental skills were: (1) Pincer grasp; (2) Holds bottle; (3) Imitates mama,
dada; (4) Peak-a-boo, pat-a-cake: (5) Sits well alone; (6) Crawls; (7) Pulls up to stand. Pet. Ex. 9, p. 11.
26
The eight assessed developmental skills were: (1) Precise pincer grasp; (2) Stands alone; (3) Walks 2-
3 steps; (4) Says 1-3 words; (5) Imitates sounds; (6) Eats and drinks sitting up; (7) Points; (8) Waves
“bye-bye.” Pet. Ex. 9, p. 10.

11
five defined skills, including whether she could walk well alone and point at one to two
body parts. 27 Id. At this examination she received her first MMR, second hepatitis B,
and fourth Hib vaccines. Id., p.1. Petitioners claim this MMR vaccine was causal of
A.A.’s current condition.

C. Growth and Development Following the October 23, 2000 Vaccination.

The first reported illness following her 15-month check-up and MMR vaccination
was nearly two months later, on December 18, 2000, when she was treated for a viral
infection and early OM. Pet. Ex. 9, p.57. The examination report from that encounter
reflected that A.A. had vomited the previous night, and awakened with a fever; however,
there is no mention of any behavioral or developmental concerns. Id. On January 25,
2001, she was treated at the Loudon Healthcare Emergency Room for second degree
burns to her hands after she touched a hot fireplace screen at home. Pet. Ex. 22, pp.
18-20.

A.A. was seen for her 18-month 28 well child visit on March 1, 2001. Additionally,
she had a runny nose and was teething. The examination report noted that the burns to
her hands were healing well. Some issues with the previous nanny were reported, but
A.A. was “opening up more” now with a new nanny. Her physical examination was
completely normal, except for a left ear infection. She was prescribed an antibiotic, with
orders to follow up in 10 to 14 days. She was behind on two vaccinations (DTaP and
IPV), which could be administered at the follow-up visit. Her development was again
measured against a defined set of skills; for the first time, A.A. did not display some of
the expected skills. The report indicated that she was fully able to drink from a cup,
walk up steps, point to body parts, and scribble. However, she had not mastered using
a spoon and only took off some clothes. Her ability to build three to four block towers
was not checked as achieved. And, the response to whether she could speak 4-10
words was “? consistency.” Despite diagnosed acute left OM, she was evaluated as a
“well 19 month old.” Pet. Ex. 9, p. 8.

A note dated March 1, 2001 continued the report from A.A.’s 18 month well child
visit. It stated:

Mom reports [decreased] language skills. Baby seems to understand [but]
sometimes refuses to talk/play games. Mom attributes above to change in
nanny – mom wasn’t pleased with nanny. Also child burned hand in
[January 2001]. New nanny seems knowledgeable [about] child
dev[elopment]. Takes [baby] to play groups, library, reads & sings, etc.
Mom to continue to talk to baby, play games, read & sing – but to back off
27
The five evaluated developmental skills were: (1) Drinks from cup; (2) Walks well alone; (3) Crawls up
steps; (4) Rolls and tosses ball; (5) Points at 1-2 body parts. Pet. Ex. 9, p. 9. Language or vocabulary
was not assessed on the examination record, but the Denver II developmental screening form reflected
that she had at least three words at 15 months of age. Id., p. 7
28
A.A. was more than 19 months old at the time of the visit.

12
if this becomes a power struggle [with baby]. [Follow up] if concerned or if
not seeing progress in language dev[elopment] over [the] next 2 months.

Pet. Ex. 9, p. 18.

The examiner also completed the medical portion of the Virginia School Entrance
Health Form, which was required prior to A.A.’s admission to school. The report
generally mirrored the findings noted in the Countryside Pediatrics record described
above and estimated her developmental level to be within normal limits. Pet. Ex. 7, p.
13.

A.A. next visited Countryside on March 23, 2001, due to coughing and
congestion. Also of concern was a reported increase in hearing loss after the “past 3
[bilateral] OM” and her ear tugging. She was diagnosed with a URI and bilateral OM. A
note indicated that A.A.’s “language skills [were] improving” and that she could say “uh-
oh” and “bye, bye.” Pet. Ex. 9, p. 56.

Several weeks later, on April 2, 2001, A.A. was treated for OM. She had
continued tugging at her ears, was “generally feeling miserable,” and had been
“sleeping a lot.” Pet. Ex. 9, p. 55. She also received her third hepatitis B and IPV and
her fourth DTaP vaccines at this examination. Id., p. 1.

On May 7, 2001, A.A. returned to follow up on her three ear infections,
accompanied by her nanny. The examination report noted concerns regarding A.A.’s
hearing, speech/language delay, and vocabulary of about six words. She was
diagnosed again with OM. For the first time, her pediatrician assessed her as
developmentally delayed in speech. Pet. Ex. 9, pp. 19, 54; see also id., p. 7 (Denver
II). 29

A.A. was next seen on June 13, 2001, for a possible urinary tract infection
[“URI”]. Her mother thought she was having problems urinating. She was noted as
crying, but consolable at the appointment. Mrs. Allen was to call if the concerns
persisted. Pet. Ex. 9, p. 53.

D. Diagnosis of and Evaluations for Speech Delay.

A.A.’s two-year well child visit took place on August 6, 2001. Her physical
examination was normal. However, she was again diagnosed as having a
developmental speech delay. The examination was “very difficult,” because A.A. was

29
The Denver Developmental Screening Test [“Denver II”] was a widely used assessment for examining
the developmental progress of young children; however, in recent years the test has fallen out of favor
with some early childhood organizations. See, e.g., Minnesota Department of Health,
http://www.health.state.mn.us/divs/fh/mch/webcourse/ devscrn/instrument.cfm (last visited Sept. 8, 2015)
(not recommended as a developmental screening instrument). The test’s publisher closed in 2015; the
testing materials are no longer available for sale. See Denver Developmental Materials, Inc.,
http://denverii.com/ (last visited Sept. 8, 2015).

13
apprehensive and screamed throughout the encounter. As a result, the examination
report, including the nine-item developmental skills checklist, was not thoroughly
completed. The two skills that were evaluated (“2-3 word sentences” and “repeats
words”) were marked as abnormal. 30 She was referred for speech evaluation. Pet. Ex.
9, p. 4.

A hearing test on August 27, 2001, was inconclusive, and she was re-evaluated
on August 31, 2001. Although testing was again incomplete because A.A. “was very
active and crying,” the obtained results suggested “normal hearing in at least one ear.”
The audiologist recommended A.A. undergo a speech and language evaluation. Pet.
Ex. 5, p. 1.

That speech and language evaluation was conducted on September 5, 2001.
A.A.’s nanny accompanied her to the appointment and served as the informant
regarding her daily communication skills and behaviors. Her parents supplied a written
history. The report noted that A.A.’s medical history was significant for ear infections.
Her developmental milestones were reportedly age-appropriate. Although she was
clumsy with walking, she was able to run and climb with coordination. Her fine motor
skills were still developing. Pet. Ex. 5, p. 4. Her speech and language landmarks were
reported “as age appropriate to a point.” Id., p. 5. She reportedly spoke “her first word
‘Quack’ at 1 year and [spoke] a little more/using animal sounds at 15 months.” Id.
However,

[s]he stopped speaking after having 3 ear infections in a row..[31] She has
just begun to put 2 words together. She has an estimated expressive
vocabulary of 30 words. In the past 6 months she has begun to babble a
lot again. She cries, points, and tugs, as her primary means of
communicating with her parents and nanny. She does not communicate
with peers. [She] reportedly will learn new words, but when she does, . . .
previous learning is lost.

Id.

After testing and examination, the speech-language pathologist provided the
following assessment:

[A.A.] is an attractive young child who would not engage with this
examiner. Based on clinical observations and caregiver’s report, she
presents with delayed receptive language skills and gaps in her
expressive language development. Of greater significance are her poor
pragmatic skills (eye contact, joint attention, etc.) and atypical behaviors:
30
The nine assessed developmental skills were: (1) Uses spoon well; (2) Eats using spoon; (3) Walks up
steps; (4) Knows name; (5) Runs without falling; (6) Builds 5-6 blocks; (7) 2-3 word sentences; (8)
Repeats words; (9) Can do simple tasks. Pet. Ex. 9, p. 4.
31
A.A. was seen for these ear infections on March 1 and 23, and April 2, 2001. Pet. Ex. 9, pp. 8, 54-56.

14
preference of objects over people, sustained odd play, tantrums,
resistance to changes in routine, showing distress for reasons not
apparent to others, lack of response to verbal cues (although hearing tests
in normal range), aloof manner, fascination with venetian blinds/lights,
desire to hold objects daily, and walking on tip toes. These combined
behaviors may suggest that she is experiencing more than just a
developmental delay.

Pet. Ex. 5, p. 11. The speech pathologist “suspect[ed] autism” and recommended that
A.A. “receive evaluation from a pediatric neurologist and/or developmental psychologist
to assess communication and behavioral patterns to determine/rule-out underlying
problems.” Id.

E. Autism Evaluations.

On September 16, 2001, A.A. was seen for a neurologic consultation with Dr.
Bennett L. Lavenstein at Children’s National Medical Center [“Children’s Hospital”], in
Washington, D.C. In the resultant report, Dr. Lavenstein noted that A.A. had been
referred by a speech pathologist who perceived “features of autism” in some of her
behaviors. Pet. Ex. 9, p. 96. He recounted that A.A., by history, had

[d]emonstrated normal behavior in the neonatal course. Subsequently
sat, walked and was appropriate in her milestones . . . . In October of
2000 she had some oral sounds but then subsequently regressed. There
has been some evidence of echolalia. Occasional stereotype movements
have been noted, especially when excited with some hand motions, and
she is noted to walk on her tip toes. At this time, she has been evaluated
in a hearing evaluation with an audiogram that was noted to be normal.
She has no history of seizures. There has been no evidence of
regression.
...
Additional behavioral features reveal that [A.A.] frequently will stare at
lights, stares in the mirror and continues to twirl her hair. She does have
some interaction with those in the environment.

Id.

Her neurologic examination was generally within normal limits, but A.A. was non-
communicative. 32 Pet. Ex. 9, p. 96. According to Dr. Lavenstein, A.A. was “a patient in
whom there may have been development of primitive speech then a regression of
speech, . . . a child who has autistic symptomatology.” Id. He recommended an
additional MRI scan and electroencephalogram [“EEG”] testing to determine whether

32
Reflexes were normal, and she was not hypertonic.

15
“there are features that would be suggestive of the Landau-Kleffner syndrome.” Id., pp.
96-97. 33

Following the neurologic consultation, A.A. underwent further diagnostic testing,
including a cerebral MRI and an EEG, as well as blood plasma analysis to obtain amino
acid levels. A radiological report dated October 3, 2001, indicated A.A.’s cerebral MRI
results were unremarkable. Pet. Ex. 4, p. 76. Similarly, an October 15, 2001, report
indicated that her EEG results were within normal limits. Pet. Ex. 9, p.93. With regard
to her amino acid levels, an October 22, 2001, laboratory report showed “mildly
elevated” tyrosine and lysine, and “borderline high” branched-chain amino acids. The
report stated, however, that clinical correlation was required, and Dr. Lavenstein
indicated they were reported as “non specific” by Dr. Mendel Tuchman, who interpreted
them. Pet. Exs. 10, p. 6; 9, p. 85.

On October 27, 2001, A.A. presented to Loudon Ear, Nose & Throat Specialists
for an evaluation of her recurrent episodes of otitis media. During the consultation,
A.A.’s mother reported that “[o]ver the last 10 months, [A.A.] ha[d] had 4-5 acute [otitis
media] episodes, . . . and, more importantly, ha[d] been diagnosed with speech delay.”
Pet. Ex. 9, p. 92. According to her mother, A.A.’s “regression began when the ear
infections started, and at least some of the developmental delay experts have indicated
that the fluid in her ear and/or recurrent acute infections could be at least part of the
problem.” Id. The physician examined A.A. and confirmed that she suffered from a
speech delay, “since at this age she still has very minimal vocabulary.” Id. She opined
that “her history of recurrent acute otitis media could be contributory since even
transient conductive hearing losses would affect her speech development at this age.”
Id. The physician recommended bilateral myringotomy and ventilation tube placement.
Id. The procedure was performed around October 2001. 34

A.A. was seen repeatedly over an approximately six week period, beginning in
November 2001, for minor illnesses, which included pharyngitis and otitis media. See
Pet. Ex. 9, pp. 43, 45, 47, 49, 51. Reports of behavioral issues were mentioned during
these visits. Id.

On the morning of December 17, 2001, A.A. was taken to the Inova Fairfax
Hospital Emergency Department because of severe pain in her abdomen and groin
area with recurrent bouts of uncontrollable crying and screaming, all of which had begun
approximately one week earlier. Pet. Ex. 4, p. 10. After an initial examination, the
emergency department physician rendered a tentative diagnosis of intermittent
abdominal pain, rule out intussusception and UTI. Id. A barium enema and a kidney,
ureter, and bladder [“KUB”] workup were negative for intussusception, but notable for
33
This evaluation also appears at Pet. Ex. 10, pp. 17-18. Duplicates of other exhibits also appear in
A.A.’s primary care records. I will not identify duplicate citations.
34
Medical records of the procedure were not filed; however, the surgery appears to have occurred around
October 2001. See Pet. Ex. 9, p. 92 (Oct. 27, 2001 audiology consult recommending procedure “in the
near future”); Pet. Ex. 4, p. 28 (Dec. 17, 2001 medical history noting “PE tubes placed ~ 3 mo ago.”).

16
increased stool in the colon, which “[t]he patient was not able to evacuate.” Id., pp. 40-
41. The emergency department recommended that A.A. be admitted to the hospital for
further testing and evaluation. Id., p. 34. A.A.’s pediatrician was informed of her status
and of the available test results, including evidence of thrombocytosis and increased C-
reactive proteins [“CRP”]. Pet. Ex. 9, p. 41. All other tests were negative, but an upper
gastrointestinal [“UGI”] was still needed. Id.

At admission, A.A.’s mother completed a comprehensive pediatric history form
regarding her health and development. Pet. Ex. 4, pp. 56-58. She reported that A.A.
was generally healthy, but noted that she had recently been sick, had allergies to eggs
and dairy, and was “slightly behind” in meeting developmental milestones. Id. She
specifically denied that A.A. had any history of gastrointestinal or genitourinary issues,
or had any ear problems. Id. A.A.’s current medications were listed as Tylenol, smart
oil, good bacteria, and unidentified supplements. Id., p. 56.

Additional history was provided to the attending physician during the admitting
examination: A.A. was reportedly in her usual state of health following a flu-like illness
when she developed increased fatigue, fussiness, and episodes of abdominal and
perineal pain. Her symptoms were accompanied by extreme tantrums, during which
she placed her hands near her perineal/paravaginal area and screamed uncontrollably.
The episodes, which started about one week earlier, occurred several times per day
and lasted for 20-30 minutes. Pet. Ex. 4, p. 28; see also id., p. 18 (pediatric history
taken by resident).

As for her earlier medical history, the attending physician recounted her burn
injury in January 2001 and a history of multiple ear infections requiring a myringotomy in
October 2001. Pet. Ex. 4, p. 28; see also id., p. 18. The physician also noted that A.A.
had undergone an EEG and MRI in October 2001 with normal results “per Dr.
Lavenstein.” Id., p. 28. Concerning her development, the physician reported that A. A.
had a language delay and toe walked, but noted that she “runs [up and down] stairs,
self feeds, [and] can speak in sentences, but talks little.” Id. Her speech reportedly had
increased after her myringotomy. Id. No history of behavioral problems was reported.
Id., p. 18. With regard to her diet, the physician noted that A.A.’s food allergies were
discovered by way of a home ELISA [enzyme-linked immunosorbent assay] test
administered by her parents. Id., p. 28. A.A. was currently “followed by a nutritionist”
and had a diet free of dairy and eggs and supplemented with vitamins. Id.

A.A. remained in the hospital overnight and was discharged on December 18,
2001. Pet. Ex. 4, p. 7. A hospital pediatric consultation report dated that day
summarized the results of various tests undertaken during A.A.’s hospitalization. The
consulting physician stated:

[A.A.’s] work up so far has included a [KUB x-ray] which is notable for
increased stool in the colon as well as a normal barium enema and normal
pelvic ultrasound with Doppler. Of note, she does have thrombocytosis
with platelets of 947 and mildly elevated CRP of 1.32. Mild anemia with

17
hemoglobin of 11.2[,] but with normal electrolytes, liver function tests and
urinalysis. An electroencephalogram being done today . . . is pending. 35

Pet. Ex. 4, p. 21.

The consultant noted that A.A.’s physical examination was normal and stated
that “[a]t this point, it is unclear if her colicky pain is clearly gastrointestinal related or
not. It is possible that she may be having some post infection enteropathy which is
worsened with her constipation.” Pet. Ex. 4, p. 21. He recommended an upper GI
examination to “rule out malrotation with intermittent volvulus and ischemia,” additional
blood work, and continued Milk of Magnesia “to clean her out.” Id. The upper GI study
performed the following day, December 19, 2001, was negative for any abnormalities,
including malrotation or duodenal obstruction. Id., p. 5.

On December 20, 2001, A.A was seen at Countryside for repeat blood testing.
The medical report noted that A.A. was feeling better. Pet. Ex. 9, p. 39. However, on
December 31, 2001, A.A.’s mother telephoned Countryside seeking an appointment.
She reported that A.A. was “hysterical, upset since [2:30 a.m.], throwing things.” She
stated that A.A. had been “evaluated at Fairfax Hospital [two] weeks [earlier] for these
same symptoms, EEG done, upper and lower GI, barium enema done, no cause was
found.” Id., p. 37. An appointment was scheduled for later that day. The corresponding
medical report noted that A.A.’s mother requested a toxicology workup for metals and
expressed concern about her decreased language ability. The possibility of autism was
raised. Id., p. 36.

On January 3, 2002, A.A. was evaluated by a gastroenterologist for constipation.
The consultation report recounted that A.A. had recently been hospitalized “for extreme
episodes of rage/irritability.” Pet. Ex. 9, p. 90. It noted that neurological evaluation was
in progress “for possible developmental disorders.” Id. Abdominal x-rays taken during
hospitalization “revealed large amount of retained stool” and the upper GI study was
normal. Id. The physician conducted a physical examination with normal findings. Id.
A diagnosis of constipation was made. Id.

On January 14, 2002, A.A.’s parents telephoned Countryside to discuss her
status. During the call, A.A.’s father stated “that he [was] 100% sure that [A.A.’s]
problems [we]re from her MMR immunization. 36 Her behavior started 30 days post

35
The EEG results were normal. Pet. Ex. 4, p. 39.
36
On January 28, 2002, Mrs. Allen was interviewed by a Loudon Public Schools social worker who was
preparing a sociocultural assessment as part of A.A.’s application for special education services. During
the interview she reported that A.A.’s “development was fine until 10-23-00 when she had her MMR
vaccination.” Pet. Ex. 8, p. 47. However, a few days later, on February 1, 2002, Mrs. Allen reported to a
school psychologist that A.A. “was very outgoing and her language skills were developing within normal
limits” until “[a]bout a year ago,” when her “speech skills began to regress and she began to struggle in
social situations.” Pet. Ex. 8, p. 27. This time frame coincides with her three ear infections, which
occurred in March and April 2001. See Pet. Ex. 9, pp. 8, 54-56.

18
MMR.” Pet. Ex. 9, p. 35. He had been doing his own research on the Internet and had
ordered several dietary supplements, including pills to improve brain function and help
the body eliminate harmful metals. 37 Id. He also stated that they had seen a nutritionist
named Kelly Dorfman who gave them “smart oil” to improve A.A.’s intelligence by 15
percent. Id.

On January 14-15, 2002, Dr. Lavenstein administered a 24-hour DigiTrace EEG
to record A.A.’s brain activity. The corresponding report noted that A.A. had “a history
of seizures. First episode was December 2001 and last episode was [January 13,
2002]. They seem to occur every day. Patient has a history of speech delay. These
[seizures] appear to be temper tantrum-like events.” Pet. Ex. 10, p. 1. Doctor
Lavenstein stated that the EEG recorded several of these tantrum events, but “[a]t no
time was there any evidence of a[n] electrographic seizure correlate.” Id. The EEG
revealed “no premonitory electrographic discharge” or “evidence of any focal
epileptiform disturbance.” Id. His impression was: “This 24 hour EEG correlating with
any temper tantrums does not reveal any evidence of paroxysmal abnormality and is
within normal limits.” Id.

In a letter dated February 2, 2002, Dr. Lavenstein provided his conclusions and
recommendations in light of the various tests performed to date. With regard to her
sleep problems, he advised that A.A. undergo a polysomnogram for further sleep
analysis, as she had a sleep disorder. Pet. Ex. 9, p. 85. Concerning her developmental
delays and behavioral problems, Dr. Lavenstein raised concern “about the possibility of
autism,” as there was “past development of primitive speech, then regression of speech
in the setting of a positive family history of epilepsy in a child who does have autistic
symptomatology.” Id. Neurologic testing showed no evidence of Landau-Kleffner
syndrome, and an MRI scan was within normal limits. Id. Laboratory studies to date
were basically normal, including an amino acid screen. Id. Although there “were some
borderline levels of tyrosine and lysine[, t]hese were felt to be nonspecific[.]” Id. Dr.
Lavenstein recommended that A.A. begin taking Klonopin to help her sleep. Id. He
noted that A.A. was to see Dr. Zimmerman in the near future. Id.

F. Evaluations and Treatment at the Kennedy Krieger Children’s Hospital.

On February 13, 2002, A.A. was evaluated by Dr. Gerald Raymond at the
Neurobehavioral Unit of the Kennedy Krieger Institute in Baltimore, Maryland. Pet. Ex.
6, p. 25. The initial evaluation report noted that A.A.’s parents were concerned about
her “loss of language and social skills, and frequent temper tantrums.” 38 Id. According
to her parents, A.A. “sat up independently at 6-months and walked by 12-months.” Id.
At the time of the evaluation, she was able to use a sippy cup, spoon, and a fork, “but

37
Mr. Allen specifically identified the following websites: www.life-enhancement.com;
www.extremehealth.com.
38
Contemporaneous with the initial visit, A.A.’s parents completed a developmental and medical history
form to provide background information for Dr. Raymond’s evaluation. Pet. Ex. 6, pp. 39-44.

19
sometimes [ate] with her hands.” Id. She also assisted with dressing and undressing,
but was not toilet-trained. Id. The report continued:

Loss of language skills was noted at approximately 16-months. Prior to
that, she was reportedly able to make ‘animal sounds’ such as ‘roar!’ when
asked, and was able to state her age. Parents feel that loss of skills was
concomitant [sic] with her 15 month MMR vaccination. She has made
some improvements since that time and is now able to count some
objects. She occasionally uses words or phrases spontaneously, such as
“daddy go look.” She may say “French fries” when the family goes to
McDonald’s. She has made better eye contact recently, since starting
dietary supplements.

Id.

With regard to her previous medical history, Dr. Raymond noted the placement of
tympanostomy tubes due to frequent otitis media, and recounted her normal
neurological evaluation in September 2001, and hospitalization for severe temper
tantrums in December 2001. Pet. Ex. 6, pp. 25-26. He also noted that A.A. had been
taking a dietary supplement, “which include[d] chelation with EDTA,” for approximately
three weeks. 39 Id., p. 26. The supplement had reportedly improved her behaviors. Id.
She was also prescribed Klonopin. Id.

Following physical examination with normal results, Dr. Raymond assessed A.A.
as “a 2-year, 6-month-old child who has had regression of language and social skills by
parental report.” Pet. Ex. 6, p. 27. He noted that her “[l]oss of language could be
suggestive of Landau-Kleffner’s syndrome; however, multiple EEG studies done in the
past have been normal.” Id. Of specific concern were A.A.’s “poor pragmatic skills,
limited eye contact, and stereotypies. These features, with a history of regression, are
suggestive of autistic disorder. In her case, based on findings, Rett Syndrome should
also be considered.” Id. He recommended continued use of Klonopin to manage her
behaviors, but cautioned use of the dietary supplement. Id. He also recommended
karyotype, fragile X DNA, and Rett studies. 40 Id.

That same day, A.A. was seen by Dr. Andrew Zimmerman, a pediatric
neurologist at the Kennedy Krieger Institute, for further evaluation of autistic symptoms.
Pet. Ex. 6, p. 23. Dr. Zimmerman’s report included the following history:

The parents report normal development until 11/00, when she underwent
regression 1-2 weeks following MMR immunization, with loss of language
and eye contact as well as social interaction. She is currently undergoing

39
Testing of A.A.’s hair reportedly had revealed “high metal content and arsenic.” Pet. Ex. 8, p. 47.
40
Fragile X genetic testing was normal. Pet. Exs. 6, p. 71; 15, p. 120. Rett syndrome genetic testing was
normal. Pet. Exs. 6, pp. 72-73; 15, pp.121-22. Both tests were performed on February 14, 2002.

20
vitamin therapy and ‘GI support’, and has had trace metal testing of the
hair. She has been followed by Dr. Bennett Lavenstein and had normal
EEGs, including an overnight study, and cranial MRI scan. She has
shown increasing toe walking in recent months. Father feels her eye
contact is improving since starting ‘oral chelation’, which is obtained
through the mail. She uses up to 100 words inconsistently and tends to
lose single words that she has once used. She is now sleeping through
the night, though she has had episodes of awakenings every 2 hours, and
will have rage episodes with hitting her head and pulling her hair.

Id.

A.A. reportedly had exhibited “repetitive behaviors, hair-twirling and echolalia.”
Pet. Ex. 6, p. 23. Doctor Zimmerman assessed “her rating on the Childhood Autism
Ratings scale [as] 35-37, in the moderately autistic range.” Id. He noted that there was
no family history of autism, and A.A. was an only child. Id. He conducted a physical
examination:

On exam, [A.A. was] fussy and reactive, does not engage or sustain eye
contact. Occasional word sounds [were] heard, as she responds to her
parents and seeks their attention briefly, and they are responsive to her. . .
. The cranium appears relatively small compared to the face, with large
features, and head circumference [in the] 50th percentile . . . . Tone is
moderate and symmetrical. She does not engage in a ball game, but
reaches into the can to obtain one. She climbs up and down a set of
steps repeatedly, has mild truncal instability but no tremor or movement
disorder. . . . Toe walking is persistent and increases with an instability of
her gait. The feet are plethoric in appearance (and are reported to change
color from pink to blue at times without apparent cause). Brief
hyperventilation episodes were reported on the exam earlier today.

Id.

Dr. Zimmerman concluded that A.A. “present[ed] an atypical history and
appearance consistent with an encephalopathy and a pervasive development disorder
(autism spectrum).” Pet. Ex. 6, p. 24. Because of her “history of regressive
encephalopathy,” he recommended genetic testing, as well as testing of quantitative
plasma amino acids and urine organic acids. Id. He also recommended that she
continue her treatment with Klonopin. Id.

On July 15, 2002, A.A. returned to Dr. Zimmerman for a follow-up appointment.
During the visit, A.A.’s mother reported that she had experienced “an increase in
language functions” due to her involvement in an infants and toddlers program, but had
“lost some ground” after the program ended for the summer. Pet. Ex. 6, p. 21. Doctor
Zimmerman noted that A.A. “ha[d] functional language, [but her] pragmatics [we]re still

21
poor and she [did] not readily engage or relate.” Id. He planned to begin to taper her
Klonopin dosage over the next few weeks. Id.; see also id., p. 88.

The report indicated that urinary organic acids had not been obtained, but that
“[g]enetic testing was normal, including chromosomes and DNA for fragile X. Rett
syndrome genetic testing was normal. There is no family history of hearing loss or
muscle weakness (mitochondrial disorder).” Pet. Ex. 6, p. 21. With regard to behavior,
Dr. Zimmerman reported that “[s]he marche[d] around the room and [was] continuously
active. She jump[ed] and ha[d] some hand flapping with excitement.” Id. He stated
that they again “reviewed the history of her loss of functions following MMR vaccine.
She has regressive encephalopathy with development of PDD (autism spectrum
disorder).” Id. He recommended that she have Applied Behavior Analysis [“ABA”]
therapy. 41 Id.

In addition to ABA therapy, Dr. Zimmerman recommended additional testing,
including “quantitative urinary organic acids, fasting serum lactic acid, serum
chemistries with liver function tests (especially AST), as well as CK (CPK),” 42 in view of
the possibility of mitochondrial disorder. Pet. Ex. 6, p. 21. He stated “[m]itochondrial
disorders are difficult to diagnose, and some of them are responsive to specific vitamin
therapies.” Id. He noted at the conclusion of his report that A.A. “had normal
quantitative amino acids, including the alanine/lysine ratio.” Id.

On November 4, 2002, A.A. returned to Dr. Zimmerman for a follow-up visit. A
nursing report noted that A.A. was non-compliant and crying during intake procedures.
Pet. Ex. 6, p. 86. It also noted that she was being treated with vitamin therapy. Id.
During the examination, A.A.’s mother reported increased sensory sensitivities and
agitation since she stopped taking Klonopin. Pet. Exs. 6, p.19. But she noted that A.A.
was “showing more responsiveness in her therapies and [was] using a few words.” Id.

With regard to test results, Dr. Zimmerman noted that

[l]aboratory testing again showed a normal amino acid profile. Her plasma
lactate was 2.2 mM/L (0.7-2.1) and CPK was 196 IU/L (0-165) . . . and
calcium 10.6 (8.5-10.4). She was struggling when the test was done and,
by report, the tourniquet was not removed. These findings are further
suggestive of a mitochondrial disorder but not clearly diagnostic.
...
We were able to obtain a urine specimen for quantitative organic acids
that will be sent to Dr. Kelly’s lab, and we also obtained a carnitine profile

41
ABA therapy consists of the “application of learning theory based on operant conditioning” and “is the
only intervention recommended by the Surgeon General” for ASD. Dwyer, 2010 WL 892250, at 272,
n.650 (internal citations omitted).
42
Blood chemistry results (Aug. 7, 2002). Pet. Ex. 6, pp. 69-70. Plasma amino acid results (Aug. 29,
2002). Id., pp. 66-67.

22
and will request repeat AST and CK determinations.[43] We will then begin
a trial of carnitine (Carnitor) increasing as tolerated up to 500 mg or 5 cc
t.i.d. . . . She will also take folic acid 0.5 mg daily. We will later consider
addition of other vitamins to the regimen depending on results. We will
also consider further evaluation for mitochondrial disorder with spinal fluid
lactic acid and/or muscle biopsy. We also obtained a carnitine profile
today.

Pet. Ex. 6, p.19.

Doctor Zimmerman prescribed carnitine and folic acid and ordered a follow-up in
three months. The discharge diagnosis was “encephalopathy.” Pet. Ex. 6, p. 85.

On November 15, 2002, A.A. was seen at Countryside due to a reported seizure
that morning. Pet. Ex. 9, p. 2. The medical record reflects that A.A. had a “grand mal”
seizure, which lasted approximately three minutes. Id. She was taken to Countryside
on the advice of Dr. Zimmerman. Id. Physical examination was normal. Id. A.A.’s new
“vitamin therapy” was mentioned. Id., p. 24. On November 23, 2002, A.A. was treated
for pharyngitis and viral infection. Id., p. 23. She reportedly “missed school all week.”
Id.

On January 13, 2003, A.A. had another EEG, the results of which indicated “a
focal cerebral disturbance of the right temporal region, but possibly involving the right
cerebral hemisphere diffusely.” Pet. Ex. 6, p. 54. The reporting physician noted “no
clear epileptiform discharges,” but could “not rule out an epileptic disorder.” Id. He
recommended an imaging study be performed “to evaluate for structural abnormalities.”
Id.

A.A. was seen at Countryside on January 21, 2003, due to another reported
grand mal seizure that morning, which lasted about two minutes. Pet. Ex. 9, p. 22. The
medical report noted that she was scheduled to see Dr. Zimmerman the following day,
but that he wanted her to be seen at Countryside “because she ha[d] had 4 seizures
since [the] new year.” Id. Physical examination was normal, with the exception of an
inflamed right tympanic membrane, diagnosed as acute OM. Id.

On January 22, 2003, A.A. returned to Dr. Zimmerman for a follow-up visit. Dr.
Zimmerman discussed A.A.’s most recent EEG results and noted that she had had four
“generalized tonic-clonic seizures, apparently nonfocal, over the past several weeks
after starting a trial of Carnitor (L-carnitine), [which] was discontinued about 3 weeks
ago.” Pet. Ex. 6, p. 15. Although her last seizure occurred the previous day and she
was presently alert, her mother observed “intermittent episodes of convergence spasm

43
The report from the repeat testing noted these results as “CK = 201 IU/L (24-170); Calcium 10.7 [8.5-
10.4]; AST 44 U/L (0-31); CO2=19; carnitine profile normal; organic acids – normal.” Pet. Ex. 6, p. 19;
see also Pet. Exs. 6, p. 56 (Johns Hopkins lab report dated Nov. 4, 2002); 6, p. 57 (KKI genetics lab
report dated Nov. 7, 2002); 6, p. 58 (KKI mass spectrometry lab report dated Nov. 8, 2002).

23
of the eyes” during the “past week or so.” Id. A.A.’s speech, however, had reportedly
improved while taking Carnitor. Id.

Doctor Zimmerman noted a limited familial history of seizures, but stated that
A.A.’s MRI films from October 2001 appeared normal, “showing no focal abnormalities
on the right side.” Pet. Ex. 6, p. 15. He recounted that she had “a history of normal
development until about 2 weeks after her MMR immunization at 18 [sic] months of age.
Up to that time, she knew her colors and was using words and was pointing. She
began repetitive behaviors and declined in her speech production with her regression.”
Id. The seizures, however, were “a new onset.” Id. This history is significantly different
from the medical records showing A.A.’s skill level at the time of vaccination and from
the histories provided before her parents asserted that the MMR vaccine was causal.
See, e.g., Pet. Ex. 9, p. 10 (pediatrician assessment at one-year checkup indicating
A.A. knew one to three words); Pet. Ex. 5, p. 4 (parental report to speech-language
pathologist on September 5, 2001, stating that A.A. spoke “her first word ‘Quack’ at 1
year and [spoke] a little more/using animal sounds at 15 months”), p. 5 (she “stopped
speaking after having 3 ear infections in a row”); Pet. Ex. 9, p. 96 (parental report to Dr.
Lavenstein on September 6, 2001, that at 15 months A.A. “had some oral sounds”; Dr.
Lavenstein’s characterization of her speech at that time as “primitive”).

Doctor Zimmerman planned a repeat EEG in six weeks, after starting A.A. on
Depakote. “Depending on the results of her repeat EEG . . . we may wish to repeat her
MRI scan, if right sided or other focal abnormalities persist.” Pet. Ex. 6, p.15. He also
recommended updated bloodwork for “CBC, AST and a valproic acid level.” Id. Any
decision “to reinstitute treatment with carnitine and other ‘mitochondrial vitamins’” would
be determined at a later date. Id. Dr. Zimmerman prescribed Depakote and ordered a
follow-up in six weeks. Id. The discharge diagnosis was, again, encephalopathy. Id.,
p. 82.

Another EEG was performed on March 3, 2003, pursuant to Dr. Zimmerman’s
order. Pet. Ex. 6, p. 50. The record reflected “no seizure discharges or localizing signs”
and was improved as compared to the one obtained on January 13, 2003. Id. The
examiner also noted that “[t]he focal attenuation of activity noticed over the right side on
the previous recording was not present in the current record; however, it must be kept in
mind that there were fewer recording channels in the current record.” Id.

That same day, A.A. was also seen by Dr. Zimmerman. He noted that A.A. was
currently taking Depakote and had only “a single seizure [the previous] week after sleep
deprivation and none ha[d] recurred.” Pet. Ex. 6, p. 13. He also reported that “[s]everal
studies suggest[ed] that [A.A.] has signs of a mitochondrial disorder.” Id. As a result,
he contacted Dr. Richard Kelley and asked him to review A.A.’s chart. Id. He intended
to ask Dr. Kelley to see A.A. clinically “to review studies[,] comment on any further
testing[,] . . . [and] recommend treatment.” Id. In the meantime, Dr. Zimmerman started
A.A. on coenzyme Q, folic acid, and thiamine; however, restarting Carnitor would be
postponed “pending Dr. Kelley’s recommendation.” Id.

24
On April 8, 2003, A.A. was seen by Dr. Richard Kelley, a metabolic specialist at
the Kennedy Krieger Institute, for further evaluation and recommendations for
treatment. Pet. Ex. 6, p. 3. In his report, Dr. Kelley recounted A.A.’s relevant history, as
provided by her parents and medical records. Id. Consistent with previous accounts,
A.A. reportedly “did well in the neonatal period and appeared to be a healthy, thriving
girl for the remainder of the first year.” Id. “[L]anguage acquisition continued to develop
normally up until the age of 15 months when, approximately one to two weeks after her
MMR immunization, [A.A.] progressively lost most of her language, visual contact, and
normal social interaction over several weeks.” Id. Extensive testing and evaluation “to
determine the cause of the losses [provided] no explanation for her autistic regression.”
Id. Then, in February 2002, A.A. was seen by Dr. Zimmerman. Although she had
regained some of her language, “and to some degree, her socialization” by the time of
the evaluation, “she continued to have major behavioral problems, including self-injury.”
Id. At that examination, she demonstrated “persistent toe-walking as well as some gait
instability, suggesting . . . a primary neurological disorder and not idiopathic autistic
spectrum disorder.” Id.

In view of the “early regressive nature of [A.A.’s] pervasive developmental
disorder and the abnormalities in [her] neurological examination, Dr. Zimmerman was
concerned that [she] might have a metabolic disease or other genetic disorder causing
her progressive developmental and neurological losses.” Pet. Ex. 6, p. 3. He “obtained
a number of basic laboratory studies for diagnosis of inborn errors of metabolism.” 44 Id.

These showed several abnormalities, including an increased plasma
alanine level, increased ratio of AST to ALT, mildly increased creatine
kinase level, mildly increased blood lactate level, and electrolyte evidence
of a mild metabolic acidosis. Negative diagnostic testing for identifiable
causes of autistic spectrum disorder included Fragile X testing, Rett
syndrome mutation analysis, plasma carnitine profile, and urinary organic
acid analysis. Taken together, the laboratory abnormalities suggested an
inborn error of mitochondrial energy metabolism. Interesting with regard
to [A.A.’s] having a possible mitochondrial disorder is that, although frank
hypoglycemia has never been documented, [A.A.] seems to [be] very
sensitive to fasting and, according her parents, ‘melts’ if she misses a
between-meal snack. She also sometimes becomes ‘stuporous’ within 15
to 20 minutes of a meal and often wants to eat in the middle of the night.

Id.

In view of the “biochemical evidence for a mitochondrial disorder . . ., and
because of success in treating similar children with pharmacological amounts of
mitochondrial cofactors,” Dr. Zimmerman had started A.A. on “stepwise
supplementation with carnitine, thiamine, and folic acid[.]” Pet. Ex. 6, p. 4. A.A.
became “very excitable and agitated on carnitine,” however, and also experienced

44
The report summarized the results of the diagnostic testing undertaken to date. Pet. Ex. 6, pp. 4-5.

25
several grand mal seizures. Id. Treatment with carnitine was discontinued and an
anticonvulsant was prescribed. Id. With regard to the effectiveness of carnitine, Dr.
Kelley noted:

Although there was suspicion that the seizures had been brought on by
treatment with carnitine, [A.A.’s] last seizure prior to initiation of
anticonvulsive therapy occurred three weeks after stopping carnitine.
After starting treatment with Depakote, [A.A.] . . . had no further seizures.
However, [she] remains significantly more excitable and agitated than
prior to initiation of any of these medications and supplements. As a
result, [A.A.’s] parents suspect that some of [her] worsening behavior has
been caused by Depakote. Also important is that [A.A] was noted to be
much more alert and focused in school after starting treatment with
carnitine, an observation that was made by teachers who at the time were
unaware of [her] new medication.

Id.

Doctor Kelley noted that A.A. did not have a history of any significant illness or
hospitalizations. Pet. Ex. 6, p. 4. It is not clear whether Dr. Kelley was unaware of her
previous hospitalization for tantrums and constipation in December 2001, or whether he
did not consider this event significant. He stated that “[a]part from the above history,
[A.A. showed] no signs or symptoms of a metabolic disease such as food intolerance,
chronic vomiting or diarrhea, recurrent infections, abnormal rashes, unusual odors, or
decompensation with otherwise simple childhood infections (apart from the MMR
immunization).” Id. He noted, however, that she “may have had more than the usual
number of ear infections and has required frequent treatment with antibiotics as well as
bilateral tympanostomy.” Id. A complete physical examination was not undertaken, as
the “visit was primarily for consultation regarding pharmacological treatment.” Id., p. 5.

In his assessment, Dr. Kelley explained:

Although autism in most children remains a diagnosis without known
cause, [A.A.] . . . has many of the historical and laboratory characteristics
that we now associate with a particular form of autistic spectrum disorder
caused by an inborn error of mitochondrial metabolism. Children with this
disorder (possibly a group of disorders), typically appear to be normal for
their first 12 months or more before a viral illness or other stress[,] such as
an immunization[,] provides the critical metabolic stress that sufficiently
taxes or compromises energy metabolism in the brain to precipitate acute
or subacute cognitive and motor deterioration. For reasons that most
likely are explained by changes in neurotransmitter receptor densities in
the brain, the period between 12 and 36 months is the time when children
with these mitochondrial disturbances appear to be most susceptible to
brain injury. Such injury may occur once or several times with additional
stresses, or, more rarely, a child may regress for many months, even in

26
the absence of specific stresses like infections or immunizations. Most
likely because the greatest susceptibility for brain [sic] occurs during a
peak period of language and social development, children who sustain this
type of mitochondrial injury often develop signs of autistic spectrum
disorder.

Id.

He then stated:

In addition to historical information consistent with an inborn error of
energy metabolism, [A.A.’s] laboratory studies are similar to those of other
children with autistic spectrum disorders and mitochondrial disease, which
for shorthand we call ‘mitochondrial PDD.’ These include a distinctly
increased level of plasma alanine relative to essential amino acids, a high
ratio of AST to ALT, mildly increased creatine kinase level, and mild
metabolic acidosis. Although [A.A.’s] plasma lactate level was only
borderline increased at 2.2 mM, the lack of a distinct lactic acidosis in
children with mitochondrial PDD together with an increased alanine level
is quite characteristic. This is also consistent with muscle biopsy studies
in mitochondrial PDD children, which typically show a significant block at
the level of complex I, the primary site of oxidation of pyruvate. Alanine,
being the amino acid form of pyruvate, is secondarily increased, but more
useful as a diagnostic marker because its degree of elevation can be
expressed relative to other amino acids, and it is not subject to artifacts
commonly encountered in doing pyruvate and lactate measurements. The
mildly increased levels of AST and creatine kinase are presumed to reflect
the involvement of muscle tissue, which, second only to the brain, has the
highest demand for mitochondrial energy metabolism.

Id., pp. 5-6.

Doctor Kelley also discussed A.A.’s “hyperactivity reaction” to carnitine, which he
explained was “not uncommon in mitochondrial PDD.” Pet. Ex. 6, p. 6. With regard to
her first seizure, he found it unlikely, “based on extensive international experience with
carnitine treatment of metabolic disorders, that carnitine could be the primary cause of a
seizure disorder, only the particular factor that demonstrates a child’s predisposition to
having seizures. Indeed, seizures are relatively common in mitochondrial PDD before
any pharmacological treatments are begun.” Id. Despite A.A.’s reaction, Dr. Kelley
believed carnitine was beneficial and recommended A.A. restart the treatment. Id. In
addition, he recommended “starting the combination of vitamins now commonly used in
the treatment of mitochondrial diseases.” 45 Id. The vitamin therapy was planned to
continue “until at least age five years. Id. In the meantime, Dr. Kelley encouraged A.A.
to “continue to be followed by Dr. Zimmerman and her developmental specialists to
monitor her progress.” Id. Although he found it unnecessary that she return for
45
The vitamin mixture was coenzyme Q10, vitamins C and E, thiamine, and lipoic acid. Pet. Ex. 6, p. 7.

27
“continued formal evaluation” at his clinic, he offered to provide advice or consultation
as necessary regarding adjustments to her medications. Id., p. 7.

Finally, Dr. Kelley noted that although “the specific genetic lesion or lesions
causing mitochondrial PDD” are not known, mitochondrial enzymatic analysis of muscle
biopsies from “several similar children” have “almost always [shown] exactly the same
biochemical profile.” Pet. Ex. 6, p. 7. As a result, “undertaking an invasive and
expensive muscle biopsy at this time would not seem to have any practical value.” Id.

On July 14, 2003, A.A. returned to Dr. Zimmerman for a follow-up visit. He noted
that she had been doing “remarkably well on the mitochondrial regimen” and provided a
favorable evaluation. Pet. Ex. 6, p. 1. He reported:

Today her eye contact is notably improved and she sustains it for several
seconds and is briefly interactive. She plays with imagination with a toy
stove and stays busy with it. She is heard to sing words clearly and is
using single words and word combinations. Her sleep has improved,
although she is up about once per week during the night and is ‘wired’ for
a few hours. This is gradually improving. She has remained seizure free
on Tegretol . . . . She still is having difficulty with transitions and sensory
sensitivities. Her growth has improved with increase in weight . . . from
60th to 95th percentile, and height . . . represents increase from 50th to
75th percentile in the last four months.

Id.

Doctor Zimmerman noted that A.A.’s positive response to the mitochondrial
regimen indicated a possible “underlying mitochondrial dysfunction which may be from a
nuclear gene that affects the mitochondria.” Pet. Ex. 6, p. 1. He ordered bloodwork and
a follow-up in three months. Id.; id, p. 76; see also Pet. Ex. 15, pp. 98-99 (laboratory
results).

On July 14, 2003, Dr. Kelly provided a letter excusing A.A. from further
vaccination due to her condition. The letter stated that A.A. “has autistic spectrum
disorder and biochemical evidence of a mitochondrial disease.” It explained that “the
physiological stress of a vaccine” can trigger the “onset of brain injury in children with
mitochondrial disease . . . as was the case for [A.A.] at the time of her MMR
immunization.” For this reason, it was recommended that A.A. not receive any further
MMR or cellular pertussis vaccines until she passed “the window of greatest
vulnerability for brain injury,” which in children with A.A.’s “type of metabolic disorder” is
six years of age. Pet. Ex. 11, p. 162.

On October 27, 2003, A.A. returned to Dr. Zimmerman for a follow-up visit. The
medical report reflected that A.A. “seem[ed] to be doing quite well on the mitochondrial
vitamin supplements.” Pet. Ex. 11, p. 160. She had been seizure free since January
2003, and the plan was to taper her off the anticonvulsant once she reached the two-

28
year point. Id. Laboratory results were generally within normal limits, including a
comprehensive metabolic panel. Id.; see also Pet. Ex. 12, pp. 52-53.

On March 15, 2004, A.A. presented for a routine neurology follow-up with Dr.
Zimmerman. According to her parents, A.A. had recently experienced a “regression” in
her behaviors and skills. Pet. Ex. 11, pp. 155-56. She was having increased sensory
integration problems, including frequent temper tantrums, and appeared less happy
than usual. Id. Additionally, certain behaviors had returned or increased, including
teeth grinding, stereotypic behaviors, humming, and toe walking. Id., p. 155. It had also
become harder for her to transition to new situations and she was observed by her
parents and teachers to be “more lethargic” and “less focused in the afternoon.” Id., pp.
155-56. Of particular concern was a teacher report that A.A. had recently had a brief
staring spell and “did not respond for a short time.” Id., p. 155. Her father also reported
observing a possible seizure-like episode, but was not certain. Id. Although A.A.
“continue[d] to speak occasionally” and “respond to specific choices given to her, [she
did] not make spontaneous speech.” Id. She was “learning things,” but her parents
were considering her placement in “a special education kindergarten program where
she w[ould] be pulled into regular programs in school.” Id., p. 156. It was noted that
A.A. “ha[d] been on the mitochondrial vitamins for one year . . . with no change in the
dosage.” Id., p. 155.

The impression was that A.A. had undergone a regression in her behaviors and
skills. Pet. Ex. 11, p. 156. The plan was to slowly increase her mitochondrial vitamins
to their target dosage. Id. The possible staring spells were “concerning,” so the plan
was to increase her anticonvulsant medication. Id., p. 157. A follow-up was scheduled
in three months. Id. Subsequent laboratory results were generally within normal limits,
with the exception of creatine, AST, and her platelet count. Pet. Ex. 12, pp. 48-49. Her
plasma carnitine was within normal limits. Pet. Ex. 12, p. 50.

On June 14, 2004, A.A. returned for a neurology follow-up with Dr. Zimmerman.
The medical report reflected that A.A. had improved since the previous visit and
“continued to do quite well on the mitochondrial vitamins.” Pet. Ex. 11, p. 148. She was
kept at her current levels, with no intention of ending the treatment “anytime soon, since
they seem to be working very effectively.” Id. Because she had been seizure-free for a
year and a half, they planned to begin tapering her anticonvulsant medications. Id.

By December 2005, A.A. was off her anticonvulsant medication and doing well.
Pet. Ex. 11, p. 135-36. In December 2008, Dr. Zimmerman planned to taper A.A. off of
the vitamin cocktail to determine whether there was “still indication of mitochondrial
dysfunction.” Pet. Ex. 12, p. 1. Although it is not clear from the record whether this
occurred, Dr. Zimmerman later wrote, in a June 21, 2010 evaluation, that A.A. continued
to have “clinical suggestion of mitochondrial dysfunction.”46 Pet. Ex. 15, p. 1. As of the

46
In his evaluation, Dr. Zimmerman noted: “When she was off all mitochondrial vitamins she seemed to
regress and Father has noted that she improves after each morning dose of Carnitor[.] . . . Mother is not
sure whether there is benefit from it, but agrees to continue with the treatment.” Pet. Ex. 15, p. 1.

29
most current record, A.A. continued to take Carnitor and the mitochondrial cocktail. Pet.
Ex. 64, pp. 1-2.

Petitioners submitted medical records dated through April 2012, at which time
A.A. was 12 years old. The records reflected regular treatment with her pediatrician 47
and ongoing care with Dr. Zimmerman and others at KKI. Pet. Exs. 61, pp. 16, 18-20,
23-28, 30-31, 33-34 (Countryside Pediatrics); 15, pp. 1, 49-52 (KKI); 64, pp. 1-2 ( KKI).

IV. Summary of Fact Testimony and Supporting Evidence.

At the July 10, 2013 hearing, A.A.’s father, James Allen, and her maternal aunt,
Susan Edick, testified with regard to A.A.’s health and development prior to her October
23, 2000 MMR vaccination, and the changes they observed over the ensuing months.
Mr. Allen and Ms. Edick provided additional evidence in the form of written affidavits.
See Pet. Exs. 78, 79. Video and photographic evidence was also submitted. See Pet.
Exs. 60, 75, 80, 81 (video); 76 (photos); Trial Exs. 1-3 (photos).

A. Mr. James Allen.

Mr. Allen testified that A.A. had a “healthy” birth and was regularly evaluated by
her pediatrician, who expressed no concerns during her first year of development.
Neither of A.A.’s parents had any concerns about her development either. Tr. at 6-7;
Pet. Ex. 78 at 2.

A.A. reached a notable milestone just prior to her first birthday, when she took
her first steps during a family vacation to the Outer Banks over the 4th of July holiday.
Tr. at 7-8; Pet. Ex. 78 at 2. A photograph taken during the trip showed A.A. standing on
the beach, smiling and playfully tugging on a rope attached to a boogie board. 48 Mr.
Allen recalled that A.A. was happy on the trip, laughing and giggling. Tr. at 8; Pet. Ex.
78 at 2. He noted that “[o]nce she started walking, it wasn’t long before she was
running, too.” Tr. at 8.

Early on, she also developed “a strong liking [for] the water” and enjoyed going to
the swimming pool. Tr. at 9. Mr. Allen stated that they frequently took A.A. to a local
swimming pool where she “would go in the wading pool and splash with other children.”
Pet. Ex. 78 at 3. One of her favorite places, though, was a large waterpark near their
home. Tr. at 9; Pet. Ex. 78 at 3. He recalled that whenever A.A. visited the park, she
was actively engaged with her surroundings—running, splashing, and playing with other
children. Tr. at 9; Pet. Ex. 78 at 3. Her affinity for water was reportedly illustrated by a
photo of A.A. with her mother in a pool. 49 The photo, which showed A.A. “kind of doing
47
A.A. continued to suffer from recurrent OM.
48
A photograph of the trip to the Outer Banks was used as Pet. Trial Ex. 1.
49
A photograph of her swimming with her mother was used as Pet. Trial Ex. 3. Mr. Allen noted that A.A.
was looking directly at the camera in the photograph. Tr. at 17.

30
the doggie paddle thing,” was taken during “the summer of 2000, around her birthday.”
Tr. at 17.

With regard to her personality, A.A. was becoming “kind of a jokester.” Tr. at 9.
For example, when asked “how big” she was, A.A. would “smile, extend her arms and
say ‘Soooo big’ and wait for everyone to laugh.” Pet. Ex. 78 at 4; see also Tr. at 9-10.
She could tell “knock-knock” jokes, too, although she “hadn’t quite learned to hold back
her laughter until the punch line[.]”50 Pet. Ex. 78 at 3-4; see also Tr. at 10. She also
loved animals and often played with the family’s dogs. Tr. at 10; Pet. Ex. 78 at 5.

Mr. Allen testified that members of both sides of the family observed A.A. during
her first year, and none expressed concern or reported any strange behaviors. Tr. at
11-12. Indeed, she “was actually accelerating, growing.” Tr. at 12. According to Mr.
Allen, she played well with other children, had no difficulty with eye contact, and
responded when called to by name. Tr. at 10-12. She was “very social.” Tr. at 11. In
fact, by her first birthday, A.A. reportedly had learned to use “well over 100 words.” Tr.
at 70-72. In view of the other evidence regarding A.A.’s language at one year of age,
this testimony cannot be accurate.

On her first birthday (July 21, 2000), A.A.’s parents threw a small party attended
by family and friends. Tr. at 12-13. A photograph taken that day shows A.A. next to her
birthday cake. 51

In the fall of that year, over the Labor Day holiday, petitioners visited A.A.’s
maternal aunt and family [“the Edicks”] at their home in Syracuse, New York. Pet. Ex.
78 at 3. Mr. Allen described A.A. as active during their stay and specifically recalled her
playing croquet with him and several of her cousins in the backyard. Id. at 4. Although
“she could only hit the ball about three feet, . . . she tried. She knew how to play. She
understood the colors.” Tr. at 33; see also Pet. Ex. 78 at 4. One of his memories was
of her “saying she was ‘a big girl’ while holding the croquet mallet and trying to hit the
ball.” Pet. Ex. 78 at 4. A photograph taken that weekend 52 showed A.A. outside during
a game of croquet, standing independently with a ball in her hands.

On October 14, 2000, the family visited a local pumpkin patch to purchase a few
pumpkins. Mr. Allen recalled that A.A. was full of energy that day and enjoyed the
experience. He specifically remembered her playing on playground equipment and

50
This statement is simply not credible. At one year of age, A.A.’s pediatrician assessed her with having
one to three words, which was considered to be normal development. Pet. Ex. 9, p. 10. Two to three
word sentences were not expected until age two years. See Pet. Ex. 9, p. 4. Indeed, petitioners
themselves reported that A.A. spoke her first word “quack” at one year and spoke “a little more/using
animal sounds” at 15 months. See Pet. Ex. 5, p. 5.
51
A photograph on her first birthday was used as Pet. Trial Ex. 2.
52
Pet. Ex. 76; see Tr. at 115 (Ms. Susan Edick testified that she took the photograph on September 3,
2000).

31
helping to choose the pumpkins. Tr. at 19-20. “She was like a kid in a candy store,
basically.” Tr. at 21. Video from that day showed A.A. walking and touching the
pumpkins. 53 In one segment, she was seen “pushing” a wheelbarrow while holding her
mother’s hand. Tr. at 20. Mr. Allen also thought she might have danced to some music
playing in the background. Tr. at 21. His recollection from that activity was of A.A.
“engaging with people, . . . with her mom and her dad, too.” Tr. at 22.

Mr. Allen also videotaped A.A. at home on that same day in various situations—
from running around the house to eating dinner. 54 In one clip, A.A. was standing in her
crib looking at the camera. Mr. Allen described her as “a little grumpy” after having just
awakened from a nap. Tr. at 15. In another, she was in the bathtub splashing and
playing with some toys. Mr. Allen noted that she made eye contact and was “very
interactive.” Id. During her bath, A.A. was playing with a rubber ducky and splashed
herself with water, “which she liked to do.” Id. He recalled her saying “quack, quack”
when asked what sound a duck makes, although the sound does not appear on the
videos. Tr. at 15-17. She “loved to make animal sounds,” but her “first words were da-
da.” Tr. at 15. 55

After her bath, A.A. was videotaped playfully running around her parents’
bedroom. See Pet. Ex. 60. When asked if she was vocalizing during the clip, Mr. Allen
responded: “Yes. A little bit. Really she was kind of doing the quack-quack still after
the bath, yeah.” Tr. at 18. In a subsequent segment, she was engaged in a “game”
with her father that involved her being chased “down the main hallway on the second
floor.” Tr. at 25. “That was a tickler bug thing . . . you know ‘I’m going to get you[.]’”
Tr. at 25. In the clip she also kissed her favorite stuffed toy—a teddy bear. Tr. at 26. In
another scene, A.A. danced to a song playing on Sesame Street. Tr. at 28- 29. A later
clip showed her seated in a high chair eating dinner. At the end of that clip she
appeared to imitate her father. He explained: “I was doing the ‘rah’ and she was doing it
back.” Tr. at 29.

On October 23, 2000, A.A. received a MMR vaccination. Although Mr. Allen was
present at the appointment, he could not recall any details. Tr. at 102-04. He did,
however, remember noticing changes in her behavior following the appointment, but not
necessarily on that day. Tr. at 73. He specifically recollected a developing awareness
that something was wrong during a neighborhood Halloween party the family attended
on October 29, 2000. Tr. at 77. The daytime, outdoor event included treats, games,
and a participatory parade for the children to show off their costumes. Tr. at 30-31; Pet.

53
Video of A.A. on October 14, 2000. Pet. Ex. 60.
54
Video of A.A. on October 14, 2000. Pet. Ex. 60. Despite confessing his love for recording his
daughter’s life (Tr. at 14.), Mr. Allen was able to find video from only three events of her entire childhood.
In view of his comments, I find the lack of other videos from holidays or birthdays in this period
inexplicable and concerning for spoliation of evidence.
55
This statement is contrary to earlier reports. See, e.g., Pet. Ex. 5, p. 5 (reporting that her first word was
“quack”).

32
Ex. 78 at 4-5. She did not want to walk in the parade and displayed little interest in
interacting with other children or participating in the activities. Tr. at 31; Pet. Ex. 78 at 4-
5. She really “seemed inattentive and passive.” Pet. Ex. 78 at 5. She “just stood in one
place like a mannequin”—she “looked stoned.” Tr. at 31. While there were “brief
moments” when she “would take one step, two steps here, one or two steps [t]here,”
she did not really walk, and definitely did not run. Tr. at 36-37.

Mr. Allen contrasted this behavior with her actions over the Labor Day weekend,
when she eagerly played croquet in her aunt’s backyard. Tr. at 32-33. On that
occasion, she was “interacting and playing games”—she wanted “to be like a big girl,” to
understand the rules and learn how to play. Tr. at 32-33. At the Halloween party,
however, she did not play games, or want to walk, stand, or interact with the other kids.
He recalled thinking that “maybe she’s really shy or something.”

In video taken during the neighborhood Halloween party, A.A. was seen standing
with other children waiting for family and friends to take photographs of the group. 56 Tr.
at 35. Mr. Allen recalled that afterwards A.A. just stood in place until every other child
had left. Id. He thought she would want to follow them for the parade, but she did not.
Id. Rather than walk, she allowed her mother to carry her for a while and then push her
in a cart. Id. Mr. Allen observed the absence of eye contact or any sounds during the
segment and noted that when they spoke to her, she showed no response. Tr. at 35-
36. “You can hear the birds, but you don’t hear her.” Tr. at 36.

Her disinterest “was kind of startling” to him—“[i]t was a big change.” Tr. at 37.
In the past, she would have had “her hands in everything.” Tr. at 38. But on that day
she was not engaged. Id. As an example, he remembered that they tried without
success to get her to play a beanbag toss game. Id. They “had to walk it up . . . and
she’d put it through the hole and that was it.” Id. The other children “sort of ran by her.”
Id. He remembered thinking “maybe she’s got a bug or something or maybe she’s just
having a bad day.” Id.

According to Mr. Allen, that day (October 29, 2000) marked the beginning of
noticeable changes in A.A.’s behavior. Tr. at 38. From there she gradually stopped
speaking and interacting, and her personality changed. Id.

That night, when she developed a fever and refused to eat, petitioners became
concerned. Tr. at 78. Because her fever was over 100 degrees, they contacted A.A.’s
doctor, who told them to administer Tylenol and to call back or come in if the fever did
not subside. Tr. at 78-79. There is no record of this telephone call. The fever lasted
four days, during which it “kind of spiked and . . . went down and spiked again.” Tr. at
39-40. As a result of her illness, A.A. was unable to trick-or-treat on Halloween night.
Id.; see also Tr. at 79-80 (testified that they contacted doctor twice); Pet. Ex. 78 at 5.
They did not take her to the doctor. Tr. at 80-81.

56
Video of A.A. on October 29, 2000. See Pet. Ex. 80, 81.

33
Mr. Allen stated that he and A.A.’s mother speculated as to the cause of the
illness, but remained uncertain. Initially, they wondered if it was something she had
eaten—perhaps too much candy or she had developed an allergy. Tr. at 40-41. They
also considered that it was a “’bug,’ like the flu[,]” or that she was maybe teething. As a
new parent, the situation “was disconcerting.” Tr. at 41; see also Pet. Ex. 78 at 5.
However, this was not A.A.’s first illness.

According to Mr. Allen, A.A.’s behavior changed significantly after the fever. He
stated that she was sleepy, cried at night, and wanted to go to bed early. Tr. at 81. She
no longer was “talkative” and would not respond or make eye contact. Tr. at 41. She
also stopped “watching Sesame Street and dancing.” Id. Instead, she would sit on the
carpet and pull pieces of thread. Id. She “wasn’t mobile like other kids.” Id. He could
not recall, though, whether he or his wife contacted A.A.’s physician about her
worsening symptoms. Tr. at 81-82; see also Tr. at 45.

Over the Veterans Day weekend in November 2000, the Edicks visited
petitioners at their home in Virginia. Tr. at 42. During their visit, the two families made
a trip to the National Zoo in Washington, D.C. Id. The zoo was A.A.’s “favorite place”
because she liked animals—especially monkeys, which she previously had watched
with fascination. Tr. at 42; Pet. Ex. 78 at 5. On this occasion, however, she was
disinterested, and cried and fussed. Tr. at 43. Mr. Allen recalled thinking that “her
behavior and lack of activity was because she was recovering from a bug.” Pet. Ex. 78
at 5; see also Tr. at 43, 83. Because of her tantrums and crying, the trip was cut short.
Tr. at 43; Pet. Ex. 78 at 6. “During this weekend,” he also “noticed that [A.A.] seemed
unsteady on her feet” and often “crawl[ed] to her destination.” Pet. Ex. 78 at 5. She
talked less, too. Tr. at 84. Petitioners did not take A.A. to the doctor, however. Tr. at
83-84.

Later that month, on Thanksgiving, the family gathered at Mr. Allen’s
grandfather’s farm. Tr. at 43. At some point that day, Mr. Allen recalled talking to his
mother about his concerns. Tr. at 44. He stated that she expressed concern, too,
because A.A. was crawling more than walking. Id. She also seemed content to sit
alone by herself. Tr. at 45; see also Pet. Ex. 78 at 6. This was noticeably different from
her behavior on October 14th, when she was “running around, . . . interactive with other
kids.” Tr. at 45. In retrospect, Mr. Allen wished that he had called the doctor, but stated
that other than reporting that he could not “get a great Kodak moment,” he was not sure
what he would have said. Tr. at 45.

Throughout the month of December 2000 “all [A.A.] wanted to do was sleep.”
Pet. Ex. 78 at 7. She also had frequent tantrums. Tr. at 86. “Her temperament
changed from a child with a big personality to one who would only smile occasionally.
Mostly, however, she stared off into space[.]” Pet. Ex. 78 at 7. On December 18, 2000,
A.A. was seen by her pediatrician; however, Mr. Allen could not recall whether he
attended or what was discussed. 57 Tr. at 84. Her behavioral problems continued to

57
The medical record on December 18, 2000, reflects a diagnosis of early OM. Pet. Ex. 9, p. 57.

34
Christmas, which made the holiday a “disappointment.” Tr. at 46. Petitioners stayed
home for Christmas and were joined by A.A.’s maternal grandparents. Id. Although
there were a lot of gifts, A.A. showed no interest in opening any of them on Christmas
morning. Tr. at 46; Pet. Ex. 78 at 7. She even “cried when a gift was placed in front of
her and left the room.” Pet. Ex. 78 at 7. Mr. Allen remembered that she “still seemed
sickly,” having had an earache the prior week. Tr. at 46. Mr. Allen shot video on
Christmas Day, 58 but noted that most of the clips showed “the good moments”—
because “she was crying a lot,” they had to reshoot numerous times. Tr. at 47-48. He
remembered that she was miserable “[t]hrough the entire day all the way up to dinner”
and was put to bed early. Tr. at 49. “For a kid on Christmas,” her behavior was “kind of
surprising.” Tr. at 48. He contrasted her unhappiness with how she behaved on her
birthday: “opening every little gift . . . and . . . going through the cake.” Tr. at 50.

The day after Christmas, A.A. appeared to feel better, so petitioners tried again
to get some “Kodak moments.” Tr. at 50. However, despite being more cooperative,
her behavior was still unusual. Though she showed increased interest in her toys, she
did not play with them “appropriately.” Tr. at 50. For example, one of the gifts was a set
of toy kitchenware, which she banged against a nearby clock and stacked in piles
instead of pretending to fix food. Tr. at 50-51. Mr. Allen stated that this was unusual—
“before[,] she wasn’t like that.” Tr. at 51. “She was in a world of her own.” Pet. Ex. 78
at 7.

After Christmas, A.A. “never really went back to where she was,” and it was
“years” before she started talking again. Tr. at 51. Petitioners eventually decided to
seek the help of specialists, because they had received no “clear answers” from her
treating physicians. Tr. at 52. He recalled the frustration he felt:

I’m going to the pediatrician and they’re treating her ear, they’re treating
her nose, they’re treating her finger, they’re treating her bellyache, they’re
treating her fever. They’re treating symptoms; they’re not treating the
whole problem. . . . And you walk out and you feel better for about a half a
day until you’re home again.

Tr. at 52. However, the medical records reflect that A.A.’s pediatrician was actively
engaged in her care and responsive to her parents’ concerns.

On March 1, 2001, petitioners took A.A. to her 18-month well child visit. Tr. at
86. Although he could not remember anything specific about the visit, Mr. Allen knew
he was concerned about her loss of speech and eye contact. Tr. at 86-87. According
to the pediatrician’s notes of that visit, A.A. did not display some of the expected skills
for a child her age, including the ability to speak 4-10 words. See Pet. Ex. 9, p. 8. It
was noted that there had been “problems” with the previous nanny, but that A.A. was
“opening up more” with the replacement. Id. The record indicated that Mrs. Allen 59
58
Video of A.A. on December 25, 2000. Pet. Exs. 74, 81.
59
The medical records of this visit do not indicate whether Mr. Allen was present.

35
expressed concern over A.A.’s language skills, noting that she “seems to understand
[but] sometimes refuses to talk/play games.” Pet. Ex. 9, p. 18. Mrs. Allen attributed this
to the previous nanny, with whom she was not pleased. Id. The pediatrician advised
Mrs. Allen to follow up if concerned or not seeing progress in language development
over the next two months. Id.

On Easter, April 15, 2001, the family visited Mr. Allen’s sister at her home, also in
Virginia. Pet. Ex. 78 at 7. Mr. Allen remembered family members noting a “dramatic
change” in A.A.’s behavior from when they saw her on her birthday and at
Thanksgiving. Id. His sister, for instance, noticed that A.A. would not respond when
called to by name. Id. at 8. Eventually his sister became “so concerned” about the
changes she saw, that she and A.A.’s mother jointly called A.A.’s pediatrician “to see if
[she] had lost her hearing.” Id. About this time, A.A. also “began tip toe walking and
hand flapping,” as well as humming and pacing back and forth. Id.; but see Tr. at 87
(toe walking began “later in the year of 2001”; and the hand-flapping did not become
“prevalent” until “around the Children’s Hospital time frame” in September). To those
who knew her, it was “becoming increasingly apparent that something was wrong.” Pet.
Ex. 78 at 8.

On April 24, 2001, Mr. Allen completed an application for A.A.’s admission to the
Village Green Day School. Tr. at 87-88. On the application, he reported that his
daughter did not have temper tantrums and noted no physiological, behavioral, or
developmental problems or difficulties, including in the areas of speech, hearing, and
mobility. See Pet. Ex. 7, pp. 7-8. He did mention, however, that she had a tantrum on a
seven-hour family trip to New York. Id. When asked to explain his responses, he
stated: “I was a first-time parent. I didn’t see my daughter as having problems. I didn’t
see her as abnormal. I didn’t know if any of these behaviors were normal or abnormal.
So that’s probably why I wrote that.” Tr. at 90. He also noted: “At that point in time, no
doctor had told me that there was anything wrong with her.” 60 Tr. at 91.

In late August and early September 2001, A.A. was examined at Blue Ridge
Speech and Hearing for a suspected hearing problem related to her recurrent OM. The
resultant examination report noted that A.A. had reportedly “said her first word ‘quack’ at
one year and [spoke] a little more/using animal sounds at 15 months, [but] stopped
speaking after having three ear infections in a row.” Tr. at 92 (quoting Pet. Ex. 5, p. 5).
When asked if this was accurate, Mr. Allen clarified that A.A. “began to stop speaking in
between each ear infection – that sentence reads as if after the three ear infections, she
stopped speaking.” Tr. at 93. Instead, “she had three ear infections as her language
skills were deteriorating.” Tr. at 93. The report concluded with a tentative diagnosis of
autism. Tr. at 53; see also Pet. Ex. 78 at 8-9.

60
This report may be technically correct in that a diagnosis of speech/language delay was not made until
May 2001, but it was clear from the March 1, 2001 well child visit that A.A.’s mother had concerns about
her development, and said that she refused to talk and play games. Pet. Ex. 9, p. 18

36
According to Mr. Allen, he and his wife were surprised by the diagnosis—in fact,
it was the “first time” that he had heard the word “autism.” Tr. at 53. He recalled staying
up every night, reading “about autism until 3 or 4 in the morning. During those hours,
[A.A] would wake up screaming and the only thing that would calm her down was
watching cartoons with music in our bedroom.” Pet. Ex. 78 at 9; see also Tr. at 96, 98-
100.

On September 6, 2001, petitioners consulted with Dr. Lavenstein, a neurologist
at Children’s Hospital in Washington, D.C. Tr. at 55. He ordered additional testing, the
results of which supported the ASD diagnosis. Pet. Ex. 78 at 10. Mr. Allen then
“applied to get [A.A.] into Kennedy Krieger through a referral” and was successful. Tr.
at 57; Pet. Ex. 78 at 10.

Additionally, during this period A.A. underwent a bilateral tympanostomy to treat
her recurrent OM. 61 The procedure reportedly did nothing to improve her behavior—
“she was still not responding.” Tr. at 53. She was also taken to the Fairfax Hospital
Emergency Department during the Christmas season in 2001 because of “one of [her]
screaming episodes.” Pet. Ex. 78 at 9. Testing revealed that she was “suffering from
intestinal blockages. She was not digesting the food and it was acting like a poison in
her body.” Pet. Ex. 78 at 9. Petitioners eventually learned that A.A. had allergies to
dairy and eggs—a condition commonly found in children with autism. Pet. Ex. 78 at 9.

When asked to identify the time frame in which he first connected the MMR
vaccine to A.A.’s problems, Mr. Allen reported that it “was a slow gradual process of
kind of putting one and one together and coming up with two.” Tr. at 96. Although he
could not say for sure, he thought it was “probably . . . late 2001.” Tr. at 97. To assist
his memory during testimony, Mr. Allen was shown a January 2002 medical record,
which reflected his statement that he was “100 percent sure that [A.A.]’s problems are
from her MMR immunization. Her behavior started 30 days post-MMR.” Tr. at 97
(quoting Pet. Ex. 9, p. 35). In view of the record, Mr. Allen testified: “At that time, if I
said I was 100 percent certain, I meant it.” Tr. at 97.

In January 2002, petitioners were notified that A.A. would no longer be allowed to
attend Village Green Day School due to behavioral difficulties. Tr. at 106. Mr. Allen
recalled that “during that time frame . . . she was having the screaming fits.” Tr. at 106.

In February 2002, petitioners met with Dr. Zimmerman for the first time. Tr. at
57. After an extensive workup, Dr. Zimmerman validated the ASD diagnosis. Tr. at 58.
He then recommended that A.A. be tested for mitochondrial disorder to help guide her
treatment. Id. Mr. Allen remembered that the testing, which involved obtaining a blood
specimen, was very difficult because A.A. struggled against the procedure. Tr. at 58-
59. After obtaining the results, Dr. Zimmerman informed petitioners that A.A. “tested
positive for mitochondrial disorder” and referred them to Dr. Kelley for further testing
and evaluation. Tr. at 59.

61
See n.34, supra, dating the procedure as likely occurring in October 2001.

37
When petitioners met with Dr. Kelley, he confirmed that A.A. had a mitochondrial
disorder and explained his recommended treatment was a “vitamin cocktail” that
included Coenzyme Q10. Tr. at 61-62. Mr. Allen testified that after A.A. began the Dr.
Kelley’s prescribed treatment, her behavior slowly, but steadily improved. Tr. at 62-63;
Pet. Ex. 78 at 10. Although she continued to toe-walk on occasion and have difficulty in
social situations, other areas were positively changed. Tr. at 63. For example, she
began to make eye contact, “her voice came back,” she was better able “to
conceptualize, particularly . . . in reading,” and her confidence increased. Tr. at 63.

As of the time of the hearing, A.A. was, according to Mr. Allen, progressing in her
development and doing well in school. 62 Tr. at Tr. at 63-68. Although her social skills
were “not quite there,” she was learning to interact with her peers and had made a
friend at school; however, she was generally more comfortable around adults. Tr. at 63-
64. He indicated that she still had stereotyped and repetitive motor mannerisms, but
took medication to reduce these symptoms. Tr. at 65-67. She also continued to take
“part of the cocktail.” Tr. at 65.

B. Ms. Susan Edick.

Ms. Edick testified that she was employed as a special education teacher in New
York State. Tr. at 108. She earned a Bachelor of Science in education and special
education from Syracuse University and a Masters of Science in education from State
University of New York in Cortland. Pet. Ex. 79 at 1-2. She was certified in New York
State in “Special Education for Infants to Adults, Early Childhood Education, Elementary
Education for Grades K-6 and Reading/Literacy Education for Grades K-12.” Pet. Ex.
79 at 2.

According to Ms. Edick, her training included learning the signs and symptoms of
various developmental disorders, including “emotional [and] learning disabilities and
autism.” 63 Tr. at 109. Two classes in particular focused on autism, with exercises on
how to identify autistic behaviors and educate children with the disorder. Tr. at 109-10.
She also studied normal growth and development in children of school age. Tr. at 109.

In the field of education, Ms. Edick worked as a K-4 resource teacher, performed
student teaching in an early education program with special needs children, and taught
special education children in an integrated co-teaching classroom. Tr. at 110. Some of
her responsibilities have included test modification, evaluation and support of student
Individualized Education Plans [“IEPs”], and identification and improvement of areas of
weakness, such as “social behavioral” issues or a “learning disability in reading and
writing.” Tr. at 110-11. Over the course of her career, Ms. Edick has both taught

62
Mr. Allen reported that A.A. was a “straight A” student in her program. Tr. at 64, 68. She was looking
forward to attending high school the following year. Tr. at 68.
63
It is unclear whether Ms. Edick had training and experience in identifying developmental disorders in
pre-school-age children.

38
autistic children and been responsible for identifying those with autism spectrum
disorder symptoms who might require intervention. Tr. at 111. She stated that in her
work she might, for example, identify “learning disabilities or learning patterns in kids or
serve on the committee for the school . . . [to] recommend further testing with a
psychologist or with speech and language therapists or with specialists, ear, nose and
throat, or doctors.” Tr. at 111.

Ms. Edick testified that, as a close relative, she had frequent opportunities to visit
petitioners and observe A.A.’s growth and development. Tr. at 112; see also Pet. Ex.
79 at 2. She also spoke often with A.A.’s mother—her sister—on the telephone. Tr. at
112. “[W]e would discuss different activities, what was going on with them in life or
family.” Tr. at 112.

Though she did not attend A.A.’s first birthday party, she remembered seeing
A.A. when petitioners visited over the Labor Day weekend in September, when she was
almost 14 months old. Tr. at 112; see also Pet. Ex. 79 at 2-3. According to Ms. Edick,
A.A. seemed “very happy, very healthy” during their stay. Tr. at 113. From what she
observed, A.A. “seemed very normal, [with] typical development for a child socially,
cognitively, physically. She was walking. She was talking, typical vocabulary, one-word
vocabulary.” Tr. at 113. A.A. sometimes used gestures to communicate, such as
pointing, bouncing, or taking one by the hand. Tr. at 113, 123. However, Ms. Edick
specifically recalled that she could say “the words that a child would have at that time”
and “numbers and count a little bit.” Tr. at 113. She estimated that A.A. knew
“approximately 12 to 20 words at that time.” 64 Tr. at 123. None of A.A.’s behaviors at
that time concerned her. Tr. at 113, 115. “She enjoyed playing . . . peek-a-boo, playing
so big. If you asked her how old she was, she would hold up her finger, one.” Tr. at
113. She appeared to understand what was being said and “would look to you to
interact and . . . play.” Tr. at 113. Ms. Edick noted A.A.’s eye contact in the photo taken
of her playing croquet in her yard—“she was laughing and smiling for the camera.” Tr.
at 114 (discussing Pet. Ex. 76).

On Halloween, Ms. Edick recalled speaking to her sister on the telephone and
asking if A.A. was dressing up to go trick-or-treating. Tr. at 116. She replied that A.A.
“hadn’t been feeling well, she was running a fever and had been for a few days.” Tr. at
116; see also Tr. at 123; Pet. Ex. 79 at 3. Her sister promised to “dress her up another
day and . . . send pictures when she’s feeling better.” Tr. at 116.

On Veterans Day weekend, the Edicks visited petitioners at their home. Tr. at
116; see also Pet. Ex. 79 at 3. During that visit, she became “very concerned because .
. . it was apparent that [A.A.] was showing

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/3132613. Public record. Not legal advice.