# Kreizenbeck v. Secretary of Health and Human Services

> United States Court of Federal Claims · August 2, 2018

URL: https://www.frixlaw.com/law-library/cases/4300738

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** August 2, 2018
- **Precedential status:** Published
- **Opinion:** Opinion
- **Judges:** Brian H. Corcoran). (cr) Service on parties made
- **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/4300738

## How later opinions describe it (automated extraction)

- finding that “the vaccinations would not have changed her clinical course and thus, the vaccinations did not significantly aggravate her preexisting condition”

## Opinion text

In The United States Court Of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 08-209V
(to be published)

************************* Special Master Corcoran
BRET KREIZENBECK and *
SANDRA KREIZENBECK as legal * Filed: June 22, 2018
representatives of a minor child, C.J.K., *
* Dismissal Without Hearing; Immune
Petitioners, * System Dysfunction; Influenza (“Flu”)
* Vaccine; Hypogammaglobulinemia;
v. * Diphtheria Tetanus Acellular Pertussis
* (“DTaP”); Measles-Mumps- Rubella
SECRETARY OF HEALTH AND * (“MMR”); Varicella; HiB Vaccine;
HUMAN SERVICES, * Pneumococcal Conjugate Vaccine (“PCV”);
* Significant Aggravation; Mitochondrial
Respondent. * Disease.
*
*************************

Richard Gage, Richard Gage, P.C., Cheyenne, WY, for Petitioners.

Ann Martin, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION GRANTING MOTION TO DISMISS CASE1

On March 26, 2008, Bret and Sandra Kreizenbeck, on behalf of their son, C.J.K., filed a
petition seeking compensation under the National Vaccine Injury Compensation Program
(“Vaccine Program”).2 The Kreizenbecks allege that the childhood vaccines (Diphtheria Tetanus
acellular Pertussis (“DTaP”), measles-mumps-rubella (“MMR”), Varicella, HiB and
pneumococcal conjugate (“PCV”)) C.J.K. received on April 1, 2005, and the influenza (“flu”)
vaccine he received on October 12, 2005, significantly aggravated his underlying, but

1
This Decision will be posted on the United States Court of Federal Claims’ website in accordance with the E-
Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to anyone with access
to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published
Decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party
has fourteen (14) days within which to request redaction “of any information furnished by that party: (1) that is a trade
secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or
similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b).
Otherwise, the entire Decision will be available in its current form. Id.
2
The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended, 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the
Act”]. Individual section references hereafter will be to § 300aa of the Act.
asymptomatic and subclinical, mitochondrial disorder, causing him to suffer from immune system
dysfunction, or hypogammaglobulinemia.3 Amended Petition at 1-2, dated Feb. 22, 2012 (ECF
No. 27) (“Amended Pet.”).

Having now completed my review of the evidentiary record and the parties’ filings, I
hereby GRANT Respondent’s Motion for a Ruling on the Record Dismissing the Case, and DENY
Petitioners’ request for compensation. As discussed below, the record does not support Petitioners’
contention that C.J.K. had any kind of mitochondrial disease or secondary dysfunction, or that the
vaccines he received injured him in any respect. Moreover, the claim is not saved by Petitioners’
eleventh-hour attempt to recast this claim as not asserting autism as a vaccine-caused injury.

I. FACTUAL BACKGROUND

Early Medical History

C.J.K. was born on March 23, 2004, following a normal pregnancy and delivery (although
he was treated for jaundice prior to being discharged home). Ex. 3 at 2, 5, 7, and 9. Throughout his
early childhood (i.e. through six months of age), C.J.K. had well-child exams with his pediatrician
at which no notable or concerning health issues were observed or expressed by Petitioners, and his
development was normal through his first year. Ex. 4 (Part 1) at 14, 29; Ex. 4 (Part 5) at 9.

The first notable health problem reflected in the medical records is from November 1, 2004,
when C.J.K. (almost eight months old at the time) presented with a one-day history of fever,
congestion, and runny nose, and was subsequently diagnosed with a viral syndrome. Ex. 4 (Part
1) at 22. Esotropia4 was also noted. Id. Three days later, C.J.K. received a flu vaccine. Id. at 23.
The medical records set forth no reaction to that vaccination. Then, on December 23, 2004, at nine
months of age, C.J.K. returned to his pediatrician for a well-child visit. Id. at 24. Again, there were
no major health concerns recorded from this visit, beyond the fact that C.J.K.’s “[left] eye turns
in.” Id. C.J.K. returned to his doctor two months later, on February 24, 2005, with a two-week
history of congestion and he was diagnosed with nasopharyngitis and treated with an antibiotic. Id.

3
Hypogammaglobulinemia, also sometimes referred to as immunodeficiency, is classified as a condition where a
patient has abnormally low levels of all classes of immunoglobulins in the blood. Dorland’s Illustrated Medical
Dictionary 901 (32nd ed. 2012) (hereinafter Dorland’s). It is also characterized by a deficient immune response. Id.
at 918.
4
Esotropia (described colloquially as being “cross-eyed”) involves a manifest deviation of an eye’s visual axis toward
the other, resulting in diplopia/double vision. Dorland’s at 648.

2
2005 Vaccinations
C.J.K. received the first set of vaccines alleged as injury-causing in this case (DTaP, Hib,
PCV, MMR, and varicella) at his one-year well-child visit on April 1, 2005. Ex. 4 at 27-28; Ex. 5
at 1. At this time, there was again no evidence of developmental problems, as all of the categories
on the pre-printed developmental screen were checked as normal. Id. The records from this visit
set forth no immediate reaction to any of these vaccines – nor do subsequent records contain
histories recording after-the-fact that a reaction was observed. As discussed below, however, the
Petitioners contend that in fact C.J.K. did experience a reaction and a decline in health beginning
at this time.

Almost two weeks later, on April 12, 2005, C.J.K. returned to the pediatrician with
rhinorrhea. Ex. 4 (Part 1) at 28. Again, no mention is made in the relevant records of any reaction.
There is subsequently a gap in the records, with no evidence of medical treatment until four and
one-half months later, on August 19, 2005, when C.J.K. presented to his pediatrician with a three-
day history of vomiting and decreased appetite, and was diagnosed with acute gastroenteritis. Id.
at 26. This record does not contain any statement of symptoms stretching into the prior months.
The very next month, on September 14, 2005, C.J.K. was treated for croup,5 following a visit to
the emergency room the night before. Id. at 30. No treater in any of these records links any vaccine
to C.J.K.’s illness, nor did Petitioners report anything of that sort to any medical providers, or
complain of observed developmental issues.

On October 12, 2005, at eighteen months of age, C.J.K. was seen by a nurse to administer
the inactivated flu vaccine. Ex. 4 (Part 2) at 1; Ex. 5 at 1. Although the record from this date states
that he registered a normal temperature, it does not appear that any broader physical examination
took place, and there are no other immediately-subsequent records identifying any additional
reactions, observed or alleged, to receipt of this vaccine. Again, however, the Petitioners have
contended that in the aftermath of the receipt of the flu vaccine, C.J.K.’s behavior changed, and
that his health declined even more precipitously.

Evidence of Developmental Problems and Purported Evidence of Immune Dysfunction

Throughout the remainder of 2005 and into 2006, it appears that C.J.K. suffered from many
additional incidents of congestion and respiratory issues – although there is no record support in

5
Croup is defined as a “condition resulting from acute partial obstruction of the upper airway.” Dorland’s at 435. It
is more often seen in children and infants. Id. Symptoms can include barking cough, hoarseness, and persistent stridor.
Id.

3
this period for the contention that the vaccines he had received were in any way associated with
his health problems, or that treaters deemed them out of the ordinary for an infant. See generally
Ex. 4 (Parts 2 & 3). He also began in late 2005 to display developmental difficulties.

C.J.K.’s next medical visit after receipt of the flu vaccine was November 8, 2005 (27
days after the vaccine’s administration). He presented with “congestion/fever, fussy/poss[ible] ear
infection.” Ex. 4 (Part 3) at 12. The doctor’s notes specifically state: “congestion x few months,
clear runny nose, Ø fever, + teething, just came back from Reno, emesis x 24°, mama-
nonspecific, doesn’t follow commands, sister [with otitis media].” Id. The doctor’s diagnoses
were “(1) URI, early [otitis media]; (2) Speech Delay.” Id. This record is accordingly the first
directly referencing anything related to C.J.K.’s development problems.

Not long after, Petitioners started expressing additional concerns for C.J.K.’s
developmental health. On November 29, 2005, and after his visit to the pediatrician earlier that
month at which time hearing problems were identified, C.J.K. had a hearing evaluation at
Hanford Speech and Hearing Center in Hanford, California. The notes from this evaluation state
that there was “a reported history of unintelligible speech and speech delay with few single words
and phrases,” while also acknowledging his recent ear infection. Ex. 8 at 1. The impression was
“normal hearing for the better ear” and middle ear stiffness on the right, and the treating doctor
recommended an evaluation of the “middle ear status.” Id. at 1-3. The next day, C.J.K.’s
pediatrician diagnosed right otitis media and an upper respiratory infection and referred him to
an ear, nose, and throat specialist, Daniel J. Schlund, M.D. Ex. 4 (Part 3) at 13.

Dr. Schlund saw C.J.K. on December 7, 2005 and recorded the following history:

[C.J.K.] is approximately a 21-month-old male who, by mom’s report, has had
problems with ear infections and hearing loss. He apparently had a flat tympanogram
on the right recently. He does not seem to hear well and does not seem to follow
commands, by mom’s report. She has noted more difficulty in the last six months.
She has tried him on soy, but he continues to have these problems. Mom is
concerned about delayed speech. He is not exposed to tobacco smoke and he is not
in daycare. He does have some occasional nasal drainage and ear pain, but no ear
drainage. His remaining history and complete review of systems are otherwise
negative or noncontributory.

Ex. 4 (Part 1) at 20 (emphasis added). Tellingly, the above-cited section from the history taken at
this evaluation not only does not record the dramatic decline in health that Petitioners now allege,
but also suggests that the behavior changes complained of at this time may have begun well before
the flu vaccine was administered that October.
4
Following examination, Dr. Schlund’s impression was resolved otitis media with effusion
and “[p]ossible autistic tendencies based on behavioral observations today.” Ex. 4 (Part 1) at 20.
One week later, on December 14, 2005, C.J.K, had a speech and language evaluation at Hanford
Speech and Hearing Center because of the noted concern by his mother about his delayed speech
and language development. Ex. 9 at 2-4. The evaluating treater stated that “Mrs. Kreizenbeck
reported that first words emerged between 15 and 18 months of age. [C.J.K.] has always babbled
and produced jargon,” but that speech had not continued as Mrs. Kreizenbeck expected. Id. at 1
(emphasis added). The speech pathologist’s biggest concerns were that C.J.K.’s development in
certain areas was not progressing as it should. Id. at 1-3. This timeframe, if accurate, would suggest
that C.J.K. was still developmentally normal in June and July 2005 (two to three months after the
date of the first vaccines at issue in this case), but that sometime in the next few months his
developmental progress slowed or changed.
C.J.K. saw hearing and speech specialists throughout the winter of 2005-06. See generally
Ex. 8 at 1, Ex. 4 (Parts 1 & 3), Ex. 9. On March 28, 2006, C.J.K. was officially diagnosed with
autism by Byrna Siegel, Ph.D., Director of University of California’s San Francisco’s Autism
Clinic. Ex. 11 at 1-19. While C.J.K today suffers from Attention Deficit Hyperactivity Disorder
(“ADHD”), there is record evidence suggesting that as of 2013, certain treaters had proposed that
his autism symptoms had “resolved,” and therefore that he no longer appropriately bears the
diagnosis. See Ex. 36 at 14 (notes from November 11, 2013 visit to Medical Genetics Clinic at
Lucile Packard Children’s Hospital). Petitioners have thus formally alleged that an autism diagnosis
for C.J.K. is now inaccurate.6

Alleged Evidence of Immunodeficiency or Mitochondrial Disease/Disorder
Although this case was filed ten years ago, Petitioners’ efforts to ascertain the cause of
C.J.K.’s purported health problems have continued apace. In particular, the Kreizenbecks have
attempted not only to obtain treatment for C.J.K.’s developmental problems, but also for what they
perceived to be an immunodeficiency or metabolic disorder in C.J.K. that could be the source of
his alleged susceptibility to illness. Records of such treatment and consultation – many of which
post-date the petition’s filing – bear heavily on the version of the claim that Petitioners currently
maintain is the “correct” one.

C.J.K. received his first evaluation for a possible immune deficiency in October 2006 (one
year after receiving the flu vaccination), with Dowain Wright, M.D., a pediatric immunologist and
rheumatologist at the immunology clinic at Valley Children’s Hospital in Madera, California. See

6
As of November 2013, C.J.K. is reported to have had significant developmental improvement, and currently attends
normal classes at school, with the assistance of Ritalin. Ex. 22 at 7. Although there were many medical records filed
regarding C.J.K.’s early treatment and diagnosis for his developmental delay (and those records have been reviewed),
they are largely inapplicable to the amended injury of hypogammaglobulinemia, and will not be discussed herein.

5
generally Ex. 6.7 The medical history from these records (likely provided to Dr. Wright by
Petitioners) asserted that C.J.K.’s propensity to be ill began at 12 months of age (or March 2005)
and was coupled with “a change in social skills,” with frequent infections beginning in his “second
year of life.” Id. at 5. Because of this history “an immune evaluation was recommended.” Id. at 5-
6. Dr. Wright’s write-up also noted that “some suggestion” was made at the time of the evaluation
that C.J.K.’s autism could be connected to immune dysregulation, but discounted the possibility of
such an association based upon his own experience (“of all my patients with immune deficiency,
only [one] is autistic”). Id. at 6-7.

Dr. Wright performed a comprehensive evaluation, with a physical examination and
extensive lab work (including tests for a variety of antibodies). Ex. 6 at 6. No abnormalities were
noted; in particular, total immunoglobulin levels were deemed normal, as well as his IgG and IgM
levels.8 Id. During the initial evaluation, Dr. Wright was unable to reach a clear conclusion as to
the source of C.J.K.’s recurrent infections, although he did express the view that C.J.K.’s repeated
sore throats alone were not evidence of immune deficiency. Id. at 7. Dr. Wright proposed that he
follow up with C.J.K. the next month, in November. By this time, however, he opined that C.J.K.
more likely suffered from allergic rhinitis than chronic viral infections (as had been related to him
by Petitioners at the first visit). Id. at 2. After an additional physical examination, and based on the
total picture he had obtained from exams plus testing, Dr. Wright affirmatively stated that he found
no evidence of an immune deficiency, and therefore scheduled no additional follow-up visits. Id.
at 3-4.

A year and one-half later, C.J.K. was evaluated in April 2008 by Sudhir Gupta, M.D., Ph.D.,
at the University of California Immunology Clinic in Irvine, California. Exs. 18, 32. (Notably, the
present lawsuit had been initiated by that date). The records from this evaluation are limited,
including no disclosure of test results, and are scrawled in an undecipherable hand. See, e.g., Ex.
32 at 1-5. It does appear, however, that Dr. Gupta found significant that (as the Petitioners likely
informed Dr. Gupta) C.J.K. had been a healthy child until 12 months of age when he “started having
rec[urring] U[pper] R[espiratory] I[nfections].” Id. at 1. Dr. Gupta’s impression was that C.J.K.
suffered from hypogammaglobulinemia/immune deficiency. Id. at 2.

7
Petitioners’ prehearing brief assiduously avoided mention of C.J.K.’s evaluation by Dr. Wright. See Prehearing
Memorandum, dated May 9, 2017, at 5 (jumping from 2006 treatments to 2013).
8
Immunoglobulin G (IgG) and Immunoglobulin M (IgM) are antibodies produced in response to infection, and their
titer levels can help monitor or detect immune deficiencies. IgM is an indicator of current infection, while IgG reflects
exposure to a past infection. Increased levels of IgG or IgM are indicia of hepatic diseases (including connective tissue
diseases and acute/chronic infections), while decreased levels are found in patients with primary/secondary immune
deficiencies. See Immunoglobulins (IgG, IgA, and IgM), Serum, Mayo Clinic Med. Laboratories,
https://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/8156 (last accessed May 30,
2018).
6
A letter, dated April 9, 2008, from Dr. Gupta to the Kreizenbecks’ health insurance
company provides a more legible, if succinct, explanation for Dr. Gupta’s findings. See generally
Ex. 18. The letter notes that “[i]mmunological analysis revealed low levels of IgG,” which
“confirms [the] diagnosis” of immune deficiency. Id. These testing results, however, do not appear
to have been filed in this case, and it is not apparent from this set of records whether the analysis
referred to was performed by Dr. Gupta or some different treater. Dr. Gupta noted the
appropriateness of IVIG treatments9 for an immune deficiency every four weeks, and asked
Petitioners’ insurance company to approve such treatments for the next six months until a re-
evaluation could be performed (although no such reevaluation evidence appears to have been
filed). Id.

In the ensuing several years, C.J.K. received a variety of treatments (some of which would
be charitably deemed “alternative medicine”) to assist him with his immunodeficiency and autism,
including hyperbaric oxygen treatments and nutritional guidance. See, e.g., Ex. 21 at 33-71, 87-90,
464; Ex. 21 at 334, 453. Then, in November 2012, C.J.K. (now eight years old) came under the
care of immunologist Sean A. McGhee, M.D., at the Lucile Packard Children’s Hospital in Palo
Alto, California, for “[r]ecurrent infection.” Ex. 25 at 3. The history of present illness section in
the record from the first visit with Dr. McGhee reported the numerous infections C.J.K. had
experienced and their insidious nature. Id. at 3. The history also claimed C.J.K. had experienced
adverse reactions to the MMR, chickenpox, and influenza vaccines – although as noted above the
contemporaneous record does not corroborate such assertions. Id. He noted at the time of C.J.K.’s
initial presentation as well that C.J.K. received nine different medications, including carnitine,10

9
Intravenous Immunoglobulin (“IVIG”) therapy is used to treat immune system disorders. During an IVIG treatment,
immunoglobulin (a combination of antibody proteins) is injected into the body to help the immune system fight off
infections. See Primary Immunodeficiency: Treatment, Mayo Clinic, https://www.mayoclinic.org/diseases-
conditions/primary-immunodeficiency/diagnosis-treatment/drc-20376910 (last accessed on May 31, 2018).
10
Carnitine is a betaine derivative found in the skeletal muscle and liver, and is typically acquired naturally through
diet. Dorland’s at 297. It is required for mitochondrial beta oxidation of fatty acid. Id. A deficiency in carnitine can
prevent the body from using fat for energy, and can result in brain dysfunction, heart failure, liver problems, and
weakness in severe cases. See Primary Carnitine Deficiency, NIH, https://ghr nlm nih.gov/condition/primary-
carnitine-deficiency (last accessed on May 31, 2018). However, some patients with a carnitine deficiency are
asymptomatic. Id.

7
creon,11 leucovorin,12 and fish oil.13 Id.

Dr. McGhee’s physical examination of C.J.K. was negative for any problems or concerns.
Ex. 25 at 4. Lab work revealed no concerns either, and found IgG levels (given the IVIG
replacement treatments he was receiving) normal. Id. Dr. McGhee recommended continued IVIG
treatment, and included in the differential the possibility as well that C.J.K. had a “possible
mitochondrial disorder,” although complete disposition of that diagnosis would require additional
treatment records that had not yet been provided to Dr. McGhee. Id. The Kreizenbecks had a
follow-up visit with Dr. McGhee in December 2012. Id. at 1-2. Dr. McGhee again noted a
“presumed” mitochondrial disorder, but identified no new treatment record evidence that would
support this diagnosis, and otherwise encouraged the Kreizenbecks to maintain IVIG treatments
for C.J.K. Id. at 1.14

Around the same time as the visits to Dr. McGhee, C.J.K. also received an evaluation in
November 2012 from a gastroenterologist, Nasha Khavari, M.D., MPH, also at Lucile Packard
Children’s Hospital. See generally Ex. 25 at 6-28. Petitioners were referred to Dr. Khavari to
obtain her views as to whether C.J.K. suffered from some kind of inflammatory bowel condition,
given his history of such symptoms (which the Kreizenbecks reported had begun at the age of
three – two years after the first round of vaccinations in question in this case). Id. at 6. Dr.
Khavari’s history also noted C.J.K.’s immune deficiencies and IVIG treatments. Id. At the time
of the initial consultation, C.J.K. had no notable abdominal symptoms, however, and the
medical records provided to Dr. Khavari from more recent years also showed no gastrointestinal

11
Creon is a trademark for preparation of pancrelipase. Dorland’s at 429. Pancrelipase is used to help improve food
digestion in certain patients with diagnoses relating to a pancreas disorder. Pancrelipase (Oral Route), Mayo Clinic,
https://www.mayoclinic.org/drugs-supplements/pancrelipase-oral-route/description/drg-20065293 (last accessed on
May 31, 2018).
12
Leucovorin is a calcium salt found in folinic acid. Dorland’s at 1026. Leucovorin supplements are used to treat
deficiencies in folic acid, for example. Leucovorin (Oral Route, Intravenous Route, Injection Route), Mayo Clinic,
https://www.mayoclinic.org/drugs-supplements/leucovorin-oral-route-intravenous-route-injection-
route/description/drg-20064503 (last accessed on May 31, 2018).
13
Fish oil is a dietary supplement used to treat a deficiency in omega-3 fatty acids (a substance needed for muscle
activity and cell growth). Fish Oil, Mayo Clinic, https://www.mayoclinic.org/drugs-supplements-fish-oil/art-
20364810 (last accessed on May 31, 2018).
14
Petitioners also filed a more recent record from their visits with Dr. McGhee in 2017. See generally Ex. 55 (February
13, 2017 progress notes). In this record, Dr. McGhee summarizes C.J.K.’s status, noting his awareness of Dr.
Natowicz’s 2013 diagnosis of mitochondrial dysfunction based on certain testing (as discussed below). After
consulting with Mrs. Kreizenbeck and learning that C.J.K. was generally doing well, Dr. McGhee proposed continued
IVIG treatments and a follow-up visit in a year, but made no novel diagnoses based on any additional evidence.

8
issues of significance. Id. at 6-7.15

After review of the results of prior endoscopies and colonoscopies performed on C.J.K.
as well as some additional testing, Dr. Khavari was unable to provide a diagnosis to explain
C.J.K.’s alleged illness or condition. Ex. 25 at 24-25. All prior biopsies had produced normal
results, and testing requested by Dr. Khavari was not consistent with inflammatory bowel disease.
Id. at 24. At best, Dr. Khavari was able to propose that C.J.K. had “some kind of autoimmune
inflammatory illness,” but could not precisely name it. Id. Dr. Khavari also noted that C.J.K.
could probably stop taking medication for colitis – and indeed that it might not be called for,
given the lack of evidence of active inflammation and its possible side effects. Id. at 25.

Testing for Possible Mitochondrial Disorder

In early 2013, Petitioners obtained formal testing for C.J.K. to evaluate whether he
suffered from some form of mitochondrial disease or dysfunction. Significantly, this testing was
performed (a) five years into this case’s life, and (b) almost eight years after the first round of
vaccines in question had been administered to C.J.K. in April 2005.

On February 6, 2013, C.J.K. saw Dr. Marvin Natowicz at the Cleveland Clinic’s Medical
Genetics Clinic in Cleveland, Ohio, to obtain a genetic and metabolic diagnostic evaluation. See
generally Ex. 26. The Cleveland Clinic is recognized as having special competence in research
and treatment of metabolic disorders such as mitochondrial disease. See, e.g., Pope v. Sec’y of
Health & Human Servs., No. 14-078V, 2017 WL 2460503, at *9 (Fed. Cl. Spec. Mstr. May 1,
2017). Dr. Natowicz’s history for C.J.K. identified his developmental problems as manifesting
with attention issues, and having begun at 16 months, or the midsummer of 2005 (and thus several
months after the April 2005 vaccinations at issue). Ex. 26 at 1. Based upon the history provided
to him, Dr. Natowicz noted that although “we do not establish an etiological basis for a person’s
autism in the majority of persons with forms of autism,” nevertheless “the family history forces
one to consider various metabolic and genetic processes and much of [C.J.K.’s] clinical story is
potentially explainable on the basis of mitochondrial energy production disorder.” Id. at 6. Dr.
Natowicz therefore proposed that blood testing be immediately performed, with possible genetic
testing later. Id. at 7.

15
The only possible findings of concern to Dr. Khavari contained in the medical records related to an endoscopy
performed in 2007 by Dr. Arthur Krigsman. Ex. 25 at 6. Notably, Dr. Krigsman is a gastroenterologist who has testified
or been referenced in other Program cases claiming autism as a vaccine injury, and has proposed in the past that there
is a plausible relationship between gastrointestinal conditions and autism. R.K. v. Sec’y of Health & Human Servs.,
No. 03-632V, 2015 WL 10936124, at *115 n.265 (Fed. Cl. Spec. Mstr. May 23, 2016), mot. for review den’d, 125
Fed. Cl. 57 (2016), aff’d, 671 F. App’x 792 (Fed. Cir. 2016). This concept, however, has never been accepted by any
special master in any entitlement decision.

9
On March 4, 2013, Dr. Natowicz commented on the results of the testing he had just
ordered. Ex. 26 at 7. Most results were normal or unworthy of concern, except for a finding of
mildly increased serum 3-methylglutaconate (“serum 3”) at 314 (with normal as in the range of
126 - 298). Dr. Natowicz noted that this compound was observed in increased levels in “only a
relatively small number of conditions, including disorder of mitochondrial energy metabolism.”
Id. He therefore proposed some follow-up tests – in particular, skin fibroblast cell16 culture tests
designed to measure the energy-producing functionality/efficiency of the mitochondria in such
cells.17 Id. Dr. Natowicz did not, however, propose conducting a muscle biopsy – a test that has
often been used to confirm the presence of a mitochondrial disorder18 – given his sense that there
was not a “compelling enough clinical history or lab data” to justify it, and he also did not propose
genetic testing given the expense. Id.

The following year, the Kreizenbecks returned to Dr. Natowicz in March 2014 for a
follow-up visit. See generally Ex. 33. Dr. Natowicz’s write-up from this visit reviewed C.J.K.’s
status, but also discussed some of the additional testing results that were obtained since the time
of his 2013 visit. Thus, Dr. Natowicz considered whole exome sequencing genetic testing that
C.J.K. had separately undergone in 2013, noting that it was largely inconclusive in aiding a
mitochondrial disease or disorder diagnosis (although certain variants shared with a tested sibling
were deemed worthy of future evaluation). Ex. 33 at 5-6; see also Ex. 39. He also considered the
results of three fibroblast cell tests that he had requested in the prior year. See generally Ex. 37.
Two of the tests yielded normal results, although the third – a fibroblast oxidative
phosphorylation test (“Ox Phos”) – found a defect in two electron transport chain complexes, a
finding that (in conjunction with the serum 3 mild elevation previously observed) suggested to
Dr. Natowicz that any mitochondrial dysfunction present was “more likely a secondary
phenomenon.” (Ex. 33 at 6, 7).

As a result of the above, Dr. Natowicz proposed another action item list to the
Kreizenbecks featuring some additional testing, although he indicated that further follow-up

16
Fibroblasts are connective tissue cells. Dorland’s at 701.
17
As noted in R.K., 2015 WL 10936124, at *39, “[m]itochondria use oxygen and food to produce adenosine
triphosphate (“ATP”), the primary source of energy for all bodily functions, through a process labeled “the respiratory
chain” or “electron transport chain.” Fibroblast cell culture tests measure ATP synthesis rates, and specifically whether
they appear impaired (thereby suggesting the presence of a mitochondrial disorder). Id. at *43.
18
In the past, muscle biopsies were deemed the “gold standard” for assessing the presence of a mitochondrial disease
or disorder, although technological advancements (in particular, the ability to conduct genetic testing) has reduced
reliance on such testing. R.V. v. Sec’y of Health & Human Servs., No. 08-504V, 2016 WL 3882519, at *11, 20 (Fed.
Cl. Spec. Mstr. Feb. 19, 2016), mot. for review den’d, 127 Fed. Cl. 136 (Fed. Cl. July 1, 2016), appeal dismissed, No.
16-2400 (Fed. Cir. Oct. 26, 2016).

10
would be dependent on the results of that testing. Ex. 33 at 7. The filed medical records reveal
that some additional testing was performed (Ex. 33 at 9-17) but largely deemed either normal or
not diagnostic of a specific disorder – although serum-3 levels were again observed to be slightly
increased, and therefore to suggest “the possibility” of disturbance of mitochondrial function. Id.
at 11.

Dr. Natowicz had another follow-up visit with C.J.K. in May 2017. See generally Ex. 54.
The notes from this visit recount the above-referenced test results and reveal no additional testing
or factors that would corroborate or rebut Dr. Natowicz’s earlier proposals about the possibility
of C.J.K. having some form of mitochondrial disorder. Id. at 1-7. An addendum to this record,
from May 29, 2017, however, does indicate that additional follow-up blood and urine tests were
“negative or unremarkable,” and that overall findings did not constitute in Dr. Natowicz’s view
any basis for altering the existing metabolic treatment plan, which Mrs. Kreizenbeck had reported
had been effective in increasing C.J.K.’s energy levels. Id. at 1, 7, and 8.

C.J.K. is currently enrolled in public school in an age appropriate class (receiving some
tutoring in speech and handwriting), but continues to have weekly IVIG injections and is on a
special diet (with dietary supplements) for his gastrointestinal issues.

II. EXPERT REPORTS

A. Petitioners’ Experts

1. Dr. Alan Levin

Dr. Levin offered the first of Petitioners’ expert opinions. See Expert Report, dated July
27, 2013, and filed as Ex. 28 (ECF No. 52-3) (“Levin Rep.”). Although a curriculum vitae (“CV”)
was never filed for Dr. Levin, his expert report indicates that he is a pathologist and board-certified
immunologist, and currently works at Immunology, Incorporated. Id. at 1.19

In his two-page report, Dr. Levin opined, in somewhat conclusory fashion, that C.J.K. “was
born with asymptomatic inborn errors of metabolism which were triggered to become symptomatic
in the form of immunological anomalies by the cytokines released by the vaccinations he received
on April 1, 2005.” Levin Rep. at 2 (emphasis added). For factual support, Dr. Levin briefly
summarized C.J.K.’s medical history, noting that he was diagnosed by Dr. Gupta in 2008 (as noted
above, three years after the vaccinations at issue) with hypogammaglobulinemia, and asserting that

19
Dr. Levin has testified on behalf of Vaccine Program petitioners on numerous occasions. See, e.g., Carter v. Sec’y
of Health & Human Servs., No. 13-633V, 2015 WL 5445828 (Fed. Cl. Spec. Mstr. Aug. 19, 2015); Bigbee v. Sec’y of
Health & Human Servs., No. 06-663V, 2012 WL 1237759 (Fed. Cl. Spec. Mstr. Mar. 22, 2012).
11
other physicians had characterized C.J.K. as having inborn errors of metabolism (although he
offered no record citation for the latter proposition – one the medical records do not support). Id.
at 1.

To support his theory, Dr. Levin cited only two pieces of medical literature. See, e.g., J.
Ming, et al., Syndromes Associated with Immunodeficiency, 46 Advanced Pediatrics 271 (1999),
filed as Ex. 30 (ECF No. 53-1) (“Ming”); K. Tsumiyama, et al., Self-Organized Criticality Theory
of Autoimmunity, PLoS ONE, e8382.doi:10.1371/journal.pone.0008382 (2009). Only Ming,
however, was filed in the case, and only in abstract form. Ming makes broad assertions about the
etiology of immune deficiency disorders and their associated “abnormalities,” which include
“inborn errors of metabolism.” Ming at 1.

2. Dr. Marcel Kinsbourne

Dr. Kinsbourne prepared Petitioners’ second-filed expert report. See Report, dated May 29,
2015, filed as Ex. 43 (ECF No. 80-2) (“Kinsbourne Rep.”). His report largely attempts to provide
a link between C.J.K’s autism/ADHD and his October 2005 receipt of the flu vaccine.

As his CV indicates, Dr. Kinsbourne is board certified in pediatrics. Ex. 44 (ECF No. 81-
1 ) (“Kinsbourne CV”), at 1. He received his medical degree in England, and he has been licensed
to practice medicine in North Carolina since 1967. Id. From 1967 to 1974, Dr. Kinsbourne served
as an associate professor in pediatrics and neurology and a senior research associate at Duke
University Medical Center before holding a series of academic positions, including professorships
in pediatrics, neurology, and psychology. Id. at 2. His clinical experience includes serving as a
senior staff physician in Ontario from 1974-1980, and a clinical associate in neurology at
Massachusetts General Hospital from 1981-1991, although (as noted in other cases) many years
have passed since he regularly saw patients. He has published several articles examining autism
(Kinsbourne CV at 15, 21-22, 27), and he is on the editorial board of several journals that deal
with the brain, such as Brain and Cognition and Brain Research. Kinsbourne CV at 3.

Overall, Dr. Kinsbourne opined that vaccines can activate immune system cells, which in
turn generate “oxidative stress.” Therefore, he believed it to be medically reasonable that
mitochondria could be stressed by vaccination (in this case, the flu vaccine) and cause “[C.J.K.’s]
current and ongoing disabilities which are sequelae of this significant aggravation.” Kinsbourne
Rep. at 5.

Dr. Kinsbourne specifically proposed that C.J.K “developed [a]utistic disorder soon after
his influenza vaccination,” and that his autism (which later evolved into ADHD) was a result of
his “genetic susceptibility and the environmental insult offered by the third influenza vaccination.”
12
Kinsbourne Rep. at 3. In particular, he proposes that the October 2005 vaccination interfered with
C.J.K.’s subclinical mitochondrial dysfunction (not discovered in C.J.K. until years later) by
increasing oxidative stress, which then clinically manifested as autistic regression. Id. at 3-4. Dr.
Kinsbourne does not propose that these vaccines directly caused C.J.K.’s developmental problems,
but that they significantly aggravated his alleged underlying mitochondrial disorder. Id. at 4.

As Dr. Kinsbourne explains in his report, mitochondria - the organelles in the body’s cells
responsible for energy production - are vulnerable to oxidative stress. Vaccines can generate
oxidative stress by activating the immune system, producing proinflammatory cytokines 20 which
can tip the balance of reactive oxygen species, resulting in cell damage and (later) autistic
symptoms once the damage arrives in the brain. Kinsbourne Rep. at 4. Dr. Kinsbourne’s report
does not explain, however, how much oxidative stress is generated by vaccines generally (or the
vaccines in question specifically), nor does it propose what level of oxidative stress is necessary
to cross the “tipping point” to cause clinical disease manifesting as autism. In addition, based on
his CV, it does not appear that Dr. Kinsbourne has the specific experience in the fields of
immunology, mitochondrial function, or metabolic disorders to opine credibly on these topics,
despite his pediatric and neurologic expertise.

Dr. Kinsbourne also addressed the timeframe in which he thought sufficient post-
vaccination oxidative stress could occur to cause autism. He opined that the byproduct of vaccine-
induced oxidative stress “typically becomes evident by two weeks after the provocative event.”
Kinsbourne Rep. at 4. In this case (according to C.J.K’s mother) C.J.K. began regressing three
weeks after receiving the flu vaccine in October 2005, which he proposed was a reasonable
timeframe. Id. To support his opinion, Dr. Kinsbourne cited approximately seven studies or articles
that he maintained shed light on the timeframe necessary for such a process to occur.21

20
Cytokine is a generic term for non-antibody proteins released by one cell population on contact with a specific
antigen. Dorland’s at 466. Cytokines act as intercellular mediators and contribute to the immune response.
“Proinflammatory” signifies that these cytokines are capable of stimulating inflammation. Id. at 1523.
21
See K. Edmonds, The Otolaryngological Manifestations of Mitochondrial Disease and the Risks of
Neurodegeneration with Infection, 128 Archives of Otolaryngology-Head & Neck Surgery 355, filed as Ex. 45 (ECF
No. 81-2); Poling, et al., Developmental Regression and Mitochondrial Dysfunction in a Child with Autism, 21 J.
Child Neurol. 170, 170-72 (2006), filed as Ex. 46 (ECF No. 81-3) (“Poling”); M. Phillips, et al., Effect of Influenza
Vaccination on Oxidative Stress Products in Breath, 4 J. Breath Research 1 (2010), filed as Ex. 47 (ECF No. 81-4);
J. Shoffner et al., Fever Plus Mitochondrial Disease Could be Risk Factors for Autistic Regression, 25 J. Child Neurol.
429, 429-34 (2010), filed as Ex. 48 (ECF No. 81-5) (“Shoffner”); S. Reuter, et al., Oxidative Stress, Inflammation and
Cancer: How are They Linked?, 4 Free Radical Biology Medicine 16 (2010), filed as Ex. 49 (ECF No. 81-6); S. Rose,
Oxidative Stress Induces Mitochondrial Dysfunction in a Subset of Autism Lymphoblastoid Cell Lines in a Well
Matched Case Control Cohort, 9 PLOS 1, filed as Ex. 50 (ECF No. 81-7), D. Fein, et al., Brief Report: Pervasive
Developmental Disorder Can Evolve into ADHD: Case Illustrations, 35 J. Autism and Developmental Disorders 525
(2005), filed as Ex. 51 (ECF No. 82-1).
13
3. Dr. Richard Boles

Petitioners’ third expert was Dr. Boles, a medical geneticist, and his report addresses
challenges by Respondent’s experts about C.J.K.’s purported mitochondrial disorder and/or
disease diagnosis. See Report, dated Mar. 18, 2016, filed as Ex. 53 (ECF No. 104-2) (“Boles
Rep.”). Dr. Boles opined that “[s]ince all aspects of [C.J.K.]’s regression and subsequent
plateauing of development occurred shortly following vaccination, vaccine-triggered injury is
highly likely.” Boles Rep. at 9.

While a brief synopsis of his background was included in his expert report, Petitioners did
not separately file a CV for Dr. Boles. Boles Rep. at 1. His report indicated that he attended the
University of California, Los Angeles for medical school and completed a residency in Pediatrics
there followed by a genetics fellowship at Yale University. Id. After serving on the faculty at the
University of Southern California, he became the director of Courtagen Life Sciences, a
biotechnology company in Woburn, Massachusetts. Id. Dr. Boles also maintains a private practice
in Pasadena, California where his emphasis is in Mitochondrial Medicine and Clinical Genomics.
Id. In addition, Dr. Boles has authored many publications, mainly in the field of genetics. Id. He
has expertise in genetics and the clinical treatment of mitochondrial diseases.

Dr. Boles began his report with a summary of C.J.K.’s medical history, relying heavily on
allegations made by the Petitioners themselves rather than on the contemporaneous medical
history. Thus, Dr. Boles notes that after the April 2005 vaccinations, Mrs. Kreizenbeck states that
she had observed C.J.K. to become “more prone to ear and throat infections,” and then, after the
December 2005 flu vaccine, she alleged that his “behavior changed, and he became more irritable
and tired easier. He stopped interacting with those around him as he had previously.” Boles Rep.
at 3. Dr. Boles did, however, also point out some record evidence from three weeks post-
vaccination, when C.J.K. was noted to have congestion, fever, and was not following commands,
as consistent with his theory. Id. In addition, Dr. Boles noted that C.J.K.’s brother also suffers from
a regressive autistic spectrum disorder, suggesting a genetic component to C.J.K.’s condition. Id.
at 4.

In addition, in opining that C.J.K. had experienced a vaccine-induced reaction due to his
underlying mitochondrial disorder, Dr. Boles stressed that C.J.K. had been seemingly normal
(including developmentally) before receiving his April 2005 vaccinations, but thereafter had a
history of gastrointestinal disorders plus a diagnosis of hypogammaglobinemia from Dr. Gupta.
Boles Rep. at 3, 4. Dr. Boles also noted testing performed by Dr. Natowicz that he deemed had
yielded results significant to a mitochondrial disease/disorder analysis. In particular, he noted the
following results: (a) positive levels of ketones from urine analysis, (b) mildly-elevated levels of
pyruvate, (c) elevated serum 3; and (d) the genetic testing demonstrating mutations consistent with
14
immunodeficiency. Id. at 5. Importantly, however, and as previously discussed, Dr. Natowicz
found only the serum 3 levels as suggestive of a mitochondrial disorder, deeming the other results
(including genetic testing) inconclusive.

Dr. Boles’s characterization of C.J.K.’s alleged metabolic condition was inconsistent.
Throughout his report, Dr. Boles refers to both mitochondrial disorders and diseases, as if they are
interchangeable concepts. See, e.g., Boles Rep. at 1, 5. He ultimately opines that C.J.K.’s condition
is “suggestive” of mitochondrial disease – but also states that “there is nothing in the records that
argues against a mitochondrial disorder.” Id. at 9 (emphasis added). He later opines that “it is
appropriate to assign a diagnosis of probable mitochondrial disorder” to C.J.K. – and yet he also
believes that “a diagnosis of mitochondrial disease can [in this case] be established far above” the
relevant preponderance standard applicable to Program claims. Id. (emphasis added). Because Dr.
Boles’s expert report does not distinguish between disease and disorder, it is difficult to ascertain
whether he means to conflate the terms or not (and as discussed below, there is sound reason to
distinguish between the two).

The remainder of Dr. Boles’s report was dedicated to rebutting various assertions made by
Respondent’s experts. See generally Boles Rep. at 6-8. In so doing, Dr. Boles reiterated his opinion
that the testing performed on C.J.K. by Dr. Natowicz was sufficient to support the diagnosis of an
underlying mitochondrial disease. Boles Rep. at 6-7. The “disease-disorder” dilemma repeats itself
in this section of his report; thus, Dr. Boles maintains that (contra Dr. McCandless) in fact C.J.K.
does bear “cardinal manifestations” of mitochondrial disease, while also deeming him to suffer
from a “mitochondrial disorder.” Id. at 6. Dr. Boles grants that some test results are not strongly
supportive of the mitochondrial disease/disorder diagnosis, although he questioned whether tests
that did not confirm the diagnosis should be given the same weight as the positive results. Id. at 6-
7.

Dr. Boles’s report made little attempt to explain how vaccines – whether the ones C.J.K.
received or others – might aggravate an underlying, asymptomatic mitochondrial condition enough
to produce immunodeficiency, developmental problems, or any other injury. He did maintain that
vaccines could worsen underlying genetic propensities toward immunodeficiency or metabolic
disorders – citing in support recent (albeit unspecified) studies on Dravet syndrome (a rare,
catastrophic form of epilepsy that begins in infancy)22 that found that the genetic factors

22
See Dravet Syndrome, NIH, https://rarediseases.info nih.gov/diseases/10430/dravet-syndrome (last accessed on
May 31, 2018). Dravet syndrome is not an illness or condition that would generally be helpful to any Program
petitioner attempting to argue that an underlying genetic-caused condition could be exacerbated by vaccine – as a line
of well-reasoned decisions stand for the proposition that because of the disease’s well-recognized genetic etiology, it
cannot be exacerbated by vaccine. Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373, 1384 (Fed. Cir. 2012),
rehearing den’d en banc, 690 F.3d 1380 (Fed. Cir. 2012), cert. den’d, 133 S.Ct. 2022 (2013); see also Oliver v. Sec’y
of Health & Human Servs., No. 10-394V, 2017 WL 747846, at *25 (Fed. Cl. Spec. Mstr. Feb. 1, 2017), aff’d, 133
15
responsible for it could create susceptibility for “vaccine-related complications.” Id. at 5. In
addition, Dr. Boles noted that in his clinical experience “the most common trigger, by far, of
acute/subacute deterioration in patients with mitochondrial disease is an infectious illness, usually
viral or bacterial.” Id. at 6. He also proposed that the precise mechanism for how a vaccine would
result in exacerbation of an underlying mitochondrial disease remained unknown, although he
speculated that it was likely immune-mediated, and (consistent with Dr. Kinsbourne) suggested
that elevated cytokines or a reactive oxygen species-mediated process might be to blame. Dr. Boles
did not, however, offer a single piece of medical literature in support of these contentions – or in
support of any contention in his report, for that matter.23

B. Respondent’s Experts

1. Dr. Shawn McCandless

Dr. McCandless authored two reports in the case. See Expert Report, dated Sept. 29, 2015,
filed as Ex. F (ECF No. 88-1) (“McCandless Rep.”); Supplemental Expert Report, dated Aug. 23,
2016, filed as Ex. U (ECF No. 107) (“McCandless Supp.”). He received his medical degree from
Temple University School of Medicine in 1988. See CV of Dr. McCandless, dated Sept. 29, 2015,
filed as Ex. G (ECF No. 88-2) (“McCandless CV”). Dr. McCandless completed his residency in
pediatrics at the University of Wisconsin Hospital and Clinics, followed by a second residency in
pediatrics at Gloucestershire Royal Hospital. Id. at 1. He is currently an associate professor of
genetics, pediatrics, and pathology at Case Western Reserve University, and also serves as a
director for several centers at the University. Id. In addition, and importantly for the present case,
he is a director of the Center for Inherited Disorders of Energy Metabolism (“CIDEM”) (affiliated
with University Hospitals Cleveland Medical Center) in Cleveland, Ohio. McCandless Rep. at 1.

At the outset, Dr. McCandless stated that he does not believe that C.J.K. has any
mitochondrial disease, dysfunction, or an inborn error of metabolism. McCandless Rep. at 5.
Rather, the “extensive testing described in these records confirms the absence of almost all known
inborn errors of metabolism, and certainly all of those that are known to present with the clinical
findings described in CJK.” Id. (emphasis added).

Fed. Cl. 341, 353 (2017), appeal docketed, No. 17-2540 (Fed. Cir. Sept. 13, 2017); . Indeed – and somewhat contrary
to Petitioners’ significant aggravation claim - Dr. Boles referenced case and animal studies that have found that
irrespective of vaccinations, humans and animals with the gene variation that C.J.K. has often exhibit clinical features
including immunodeficiency, developmental delay, and hearing loss as a natural progression of their condition. Boles
Rep. at 5.
23
Dr. Boles’s report was filed in this case in March 2016, after several requests to extend the time in which to do so.
Given the amount of time that has since passed, Petitioners have no excuse for not filing any such materials by the
present date.
16
To support his conclusion, Dr. McCandless engaged in a detailed review of C.J.K.’s
medical testing results. Based upon that review, he opined that the record did not establish “any
cardinal symptoms of [primary] mitochondrial disease.” McCandless Rep. at 3; R. Haas, et al.,
Mitochondrial Disease: A Practical Approach for Primary Care Physicians, 120 Pediatrics 1326
(2007), filed as Ex. H (ECF No. 88-3) (“Haas”). Specifically, Dr. McCandless noted that (a) C.J.K.
never displayed elevated lactate and pyruvate in blood, urine, or cerebrospinal fluid (“CSF”); (b)
did not manifest increased alanine in blood or CSF; (c) tests revealed no evidence of significant
increase in tricarboxylic acid; and (d) no other amino acids in blood (proline or lower than normal
citrulline or arginine) were detected. McCandless Rep. at 3; J. Smeitink, et al., Mitochondrial
Medicine: A Metabolic Perspective on the Pathology of Oxidative Phosphorylation Disorders, 3
Cell Metabolism 9 (2006), filed as Ex. I (ECF No. 88-4) (“Smeitink”). Dr. McCandless
acknowledged that C.J.K. had slightly elevated serum 3 levels, but considered that to be a “non-
specific finding,” especially in the absence of other persuasive indicators of a primary
mitochondrial disease. McCandless Rep. at 3; Ex. 26 at 7.

Dr. McCandless then addressed other testing performed on C.J.K. McCandless Rep. at 3.
First, he considered the fibroblast test that measured the lactic and pyruvic acids accumulated in
skin cells. C.J.K. was found to be within a normal result of 14; true cases of mitochondrial
dysfunction, by contrast, would show a ratio higher than 20. Id.; Ex. 37 at 2. Second, he reviewed
the test of C.J.K.’s individual components of the mitochondrial respiratory chain. These
components are measured individually, and the results of each such test for C.J.K. was normal.
McCandless Rep. at 3; Ex. 37 at 3.

The final fibroblast test Dr. McCandless discussed was the Ox Phos, which according to
Dr. McCandless measures “the ability of the mitochondria to take up the compounds, to normally
metabolize the substrates added by extracting the energy from the chemical bonds in the
compounds, and to measure the respiratory chain’s ability to use that energy to make ATP.”
McCandless Rep. at 3.24 Unlike the other fibroblast tests, Dr. McCandless admitted (consistent
with the view of Dr. Natowicz) that this result did reveal mild dysfunction in the first part of the
electronic transport chain (complex 1). Id. However, Dr. McCandless posited, its significance
needed to be evaluated against the overall context of C.J.K.’s other clinical and laboratory findings
– which were not supportive of the conclusion that C.J.K. had any mitochondrial disease or
disorder. Id. When given its proper weight, this somewhat significant positive result was, Dr.
McCandless proposed, most likely “not due to a specific underlying defect of mitochondrial
electron transport chain itself,” but instead reflected “some secondary suppressor of the electron
transport chain either found in the patient, or [caused by] . . . a problem in the laboratory,” and

24
For a definition of ATP, see footnote 17 above.
17
therefore was not supportive of the conclusion that C.J.K. had any mitochondrial dysfunction. Id.
at 3-4; Ex. 33 at 7.

Although admittedly not an immunologist, Dr. McCandless attempted to rebut Dr.
Kinsbourne’s theory of oxidative stress caused by vaccines. McCandless Rep. at 6. Mitochondria,
Dr. McCandless maintained, have the ability to defend against injury, so only those individuals
with severe defects in mitochondrial function are likely to develop symptoms as a result of an
environmental insult. Id. at 5. Indeed, mitochondria are “exposed to oxidative stress constantly,”
rendering “without merit” the argument that an environmental factor like a vaccine could be
sufficient to result in significant injury as is alleged in this case. Id.

Dr. McCandless also offered a second expert report aimed at responding to points made by
Dr. Boles. See generally McCandless Supp. In it, Dr. McCandless noted Dr. Boles’s concession
that there was an “absence of proof” supporting the conclusion that C.J.K. suffered from “primary”
mitochondrial disorder (i.e. a known mitochondrial disease), adding that Dr. Natowicz (with whom
Dr. McCandless frequently interacts professionally) had himself never so proposed, given his use
of the term “secondary phenomenon.” McCandless Supp. at 1-2. Placing greater emphasis on the
lab findings generated by Dr. Natowicz, and relying on his own expertise at CIDEM interpreting
tests aimed at evaluating mitochondrial function, Dr. McCandless disputed Dr. Boles’s attempt to
define “trivial” increases in certain biomarkers as “highly abnormal.” Id. at 2. The Ox Phos result
was also “ambiguous at best” in Dr. McCandless’s estimation – and, when considered in light of
the lab’s own discussion of that result (in connection with the other fibroblast results) could not
properly be deemed “diagnostic of a primary mitochondrial disease.” Id. at 3, 4; see also Ex. 31 at
4.

2. Dr. Dean Jones, Ph.D.

Dr. Jones offered an opinion based on his expertise in redox biology25 and mitochondrial
metabolism. He authored one report for Respondent, which was limited to addressing Dr.
Kinsbourne’s report. See Expert Report, filed as Ex. J, dated Sept. 29, 2015 (ECF No. 89-1) (“Jones
Rep.”).

Dr. Jones is currently employed as a professor at the Emory University of School of
Medicine. See CV, filed as Ex. K, dated Sept. 29, 2015 (ECF No. 89-2) (“Jones CV”). He studied
biochemistry and the University of Illinois in Urbana, Illinois, prior to obtaining his Ph.D. in

25
Redox Biology is the study of reactive species, such as superoxide, hydrogen peroxide, and nitric oxide. See Redox
Biology (RB), Ctr. for Cancer Research, NIH, https://ccr.cancer.gov/training/trainee-resources/courses-workshops/rb
(last accessed on May 31, 2018). Specialists in redox biology typically analyze how redox-active species are generated,
and their effects on the cellular and physiological parts of the body. Id.
18
biochemistry at Oregon Health Sciences University in Portland, Oregon. Id. at 1. His research has
been focused on mitochondrial metabolism, oxidative stress, and redox biology. Jones Rep. at 1.
Dr. Jones acknowledges that he does not have clinical training in immunology, neurology,
gastroenterology, or genetics. Id.

Dr. Jones, like Dr. McCandless, opined that C.J.K. does not have a mitochondrial disease
or disorder, based on the “cumulative laboratory results.” Jones Rep. at 2. He particularly disputed
whether the Ox Phos test was sufficient by itself to conclude that C.J.K. had a mitochondrial
disease, without additional controls and repeat measurements. Id. C.J.K. also lacked some of the
“major deficits” that would characterize an individual suffering from a mitochondrial disease or
disorder, making it more difficult to conclude that there could be any causal connection between
vaccination and injury. Id. at 4. He referenced a case study cited by Dr. Kinsbourne - Poling, et
al., Developmental Regression and Mitochondrial Dysfunction in a Child with Autism, 21 J. Child
Neurol. 170, 170-172 (2006), filed as Ex. 46 (ECF No. 81-3) (“Poling”) – to illustrate his point,
noting the vast differences in test results relating to mitochondrial function as reported in Poling
versus what C.J.K. displayed. Jones Rep. at 4.

Dr. Jones also took specific issue with Dr. Kinsbourne’s descriptions of oxidative stress,
stating they “represent[] a very non-professional write-up or a nearly complete ignorance of the
concepts.” Jones Rep. at 5. In connection with this contention, Dr. Jones referenced several studies
that have been unable to find a statistically significant role for oxidative stress in initiating a
pathogenic process or causing neurologic harm (autism or developmental problems). Id. at 5-6; M.
Goodman, et al., Clinical Trials of Antioxidants as Cancer Prevention Agents: Past, Present, and
Future, 51 Free Radical Biology & Med. 1068 (2011), filed as Ex. M (ECF No. 94-2). Rather,
recent studies have suggested that reactive oxidants produced in response to oxidative stress have
a beneficial role, acting as major components of growth and development. Id. at 6; M. Lampl,
Human Growth from the Cell to the Organism: Saltations and Integrative Physiology, 36 Annals
of Human Biology 478-95 (2009), filed as Ex. P (ECF No. 84-5). Dr. Jones also proposed that the
signaling of certain cytokines (TNF alpha and IL-6 and IL-1 beta) encouraged by vaccines was
common to normal physiology rather than the component of a pathologic process. Id. at 7.

3. Dr. Max Wiznitzer26

For his third expert report, Respondent offered the opinion of a pediatric neurologist, Dr.
Wiznitzer. See Expert Report, filed as Ex. A, dated Sept. 29, 2015 (ECF No. 87-1) (“Wiznitzer
26
Because Petitioners have formally represented that they are no longer pursuing the claim that vaccines caused
C.J.K.’s autism, I am setting forth an abbreviated summary of Dr. Wiznitzer’s opinion – although (as discussed below)
I do not find fully credible Petitioners’ assertions that they have fully abandoned developmental problems as an alleged
result of the vaccinations at issue.

19
Rep.”). Dr. Wiznitzer’s overall impression was that C.J.K. had clinical features of autism prior to
his influenza vaccination, and that none of those developmental problems “were caused or
aggravated by his 10/12/05 influenza vaccination.” Id. at 8.

Dr. Wiznitzer graduated from the honors program in medical education at Northwestern
University, where he received a bachelors of science in medicine in 1975 and then his medical
degree in 1977. See CV of Dr. Wiznitzer, filed as Ex. B, dated Sep. 29, 2015 (ECF No. 87-2)
(“Wiznitzer CV”). Id. at 1. He completed a three-year internship and residency in pediatrics at
Cincinnati Children’s Hospital, followed by a one-year fellowship in child development and
developmental disorders at the Cincinnati Center for Developmental Disorders. Id. He also
completed a three-year child neurology fellowship at the University of Pennsylvania and
Children’s Hospital of Philadelphia, followed by a two-year National Institute of Health fellowship
in disorders of higher cortical function in children at the Albert Einstein College of Medicine in
the Bronx, New York (which involved working with children with autism spectrum disorders). Id.
Dr. Wiznitzer currently works at the University Hospitals of Cleveland in Cleveland, Ohio. Id. at
2. Dr. Wiznitzer holds board certifications in pediatrics and neurology. Id. at 5.

Dr. Wiznitzer does not dispute that C.J.K. was accurately diagnosed with autism in March
2006. Wiznitzer Rep. at 7. However, Dr. Wiznitzer opined that C.J.K.’s clinical history was
consistent with “the trajectories reported in the autism population,” rather than the product of a
disease process initiated by vaccines. Id. Dr. Wiznitzer did emphasize that C.J.K. was never
diagnosed with developmental regression; rather, the records reveal that Mrs. Kreizenbeck, in
association with certain of C.J.K.’s pediatricians, expressed concern that he was not progressing
as expected. Id. The distinction (between regression and a plateau in development) Dr. Wiznitzer
deemed significant, and related directly to his opinion that vaccines were not the cause of C.J.K.’s
autism. Id. Indeed, Dr. Wiznitzer highlighted the fact that some indications in the medical records
suggested that C.J.K.’s autism began prior to his vaccinations (although he made this point relying
on records in which C.J.K.’s medical history was recounted after the fact, rather than in
contemporaneous records). Id.

III. Factual Witness Statements

Filed with Dr. Kinsbourne’s report was an affidavit from Mrs. Kreizenbeck, dated May 29,
2015, describing the changes she witnessed in C.J.K.’s condition following his receipt of the
vaccines at issue. See generally Ex. 42. In it, Mrs. Kreizenbeck maintained that C.J.K.’s health
worsened after his April 2005 vaccination, beginning with a fever. Ex. 42 at 2 ¶¶ 4-5. Although
admitting that she could not precisely recall a similar reaction in October, she nevertheless asserted
that C.J.K. commonly had post-vaccination fevers, and therefore he likely experienced one after
the October 2005 vaccination as well. Id. at ¶ 7. She recalled observing more serious health and
20
behavioral changes after receipt of the October flu vaccine. Id. at ¶ 8. Mrs. Kreizenbeck also
asserted that she first learned that C.J.K. might be autistic in December 2005, at a visit to an ENT
doctor, and that the behaviors he displayed had not existed before October of that year (an assertion
belied by the medical record, which places onset of behavioral changes as early July 2005). Ex. 42
at 3 ¶1; Ex. 4 (Part 1) at 20.

IV. Procedural History and Evolution of Petitioners’ Claim

This action was initiated over ten years ago, and for large periods of its existence Petitioners
unquestionably sought to establish that C.J.K.’s autism was the result of his 2005 vaccinations.
Thus, the original 2008 petition alleged that C.J.K. “suffered from gastrointestinal disease, immune
dysfunction, encephalitis, heavy metal poisoning, nutritional, metabolic, and mitochondrial
dysfunction . . . by the multiple vaccinations [C.J.K.] received on April 1, 2005, and the thimerosal
based Flu vaccine received on Oct 12, 2005. . . . [P]etitioners believe that the vaccinations that
[C.J.K.] received . . . resulted in [a]utism.” Petition, dated March 26, 2008, at ¶ 14.

The Kreizenbecks began as pro se petitioners. During the case’s first eighteen months, very
little occurred. Because autism was alleged as an injury in this case, it was included within the
Omnibus Autism Proceeding (“OAP”)27, and was stayed pending the results of the six OAP test
27
In the OAP, thousands of petitioners’ claims that certain vaccines caused autism were joined for purposes of efficient
resolution. A “Petitioners’ Steering Committee” was formed by many attorneys who represent Vaccine Program
petitioners, with about 180 attorneys participating. This group chose “test” cases to represent the entire docket in the
OAP, with the understanding that the outcomes in these cases would be applied to cases with similar facts alleging
similar theories.

The Petitioners’ Steering Committee ultimately chose six test cases to present two different theories regarding autism
causation. The first theory alleged that the measles portion of the MMR vaccine precipitated autism, or, in the
alternative, that MMR plus thimerosal-containing vaccines caused autism, while the second theory alleged that the
mercury contained in thimerosal-containing vaccines could affect an infant’s brain, leading to autism.

The first theory was rejected in three test case decisions, all of which were subsequently affirmed. See generally
Cedillo v. Sec’y of Health & Human Servs., No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), mot.
for review den’d, 89 Fed. Cl. 158 (2009), aff’d, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec’y of Health &
Human Servs., No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), mot. for review den’d, 88 Fed.
Cl. 473 (2009), aff’d, 605 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec’y of Health & Human Servs., No. 01-162V, 2009
WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009).

The second theory was similarly rejected. Dwyer v. Sec’y of Health & Human Servs., No. 03-1202V, 2010 WL
892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); King v. Sec’y of Health & Human Servs., No. 03-584V, 2010 WL 892296
(Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v. Sec’y of Health & Human Servs., No. 03-215V, 2010 WL 892248 (Fed.
Cl. Spec. Mstr. Mar. 12, 2010).

After the OAP’s conclusion, a total of 11 lengthy decisions by special masters, the judges of the U.S. Court of Federal
Claims, and the panels of the U.S. Court of Appeals for the Federal Circuit had unanimously rejected the petitioners’
claims. These decisions found no persuasive evidence that the MMR vaccine or thimerosal-containing vaccines caused
autism. The OAP proceedings concluded in 2010.
21
cases. After the test cases were resolved (unsuccessfully for any of the relevant petitioners), the
Kreizenbecks chose to continue with their claim, and were ordered to produce an expert report.
Order, dated September 22, 2010 (ECF No. 9). By December 7, 2011 (almost four years after the
petition was filed), however, no expert report had been filed (after seeking several extensions of
time) although Petitioners had retained Mr. Richard Gage as their attorney. See Consented Motion
to Substitute Richard Gage in Place of Pro Se, dated Dec. 7, 2011 (ECF No. 21).

On February 22, 2012, Petitioners refined their causation theory in an amended petition.
See generally Amended Pet. They now alleged that the flu vaccine C.J.K. received on October 12,
2005 (rather than his April 1, 2005 childhood vaccines), had “adversely effected his immune
system,” including diarrhea and vomiting. See Amended Petition, dated Feb. 22, 2012 (ECF No.
27) (“Amended Pet.”). Filed with the amended petition was a motion for an extension of time,
which explicitly stated “[t]his case is now being prosecuted as an immune system injury case. This
case is no longer being prosecuted as an autism injury case.” See Motion for an Extension of
Time, dated Feb. 22, 2012 (ECF No. 27) at ¶2 (emphasis added). However, Petitioners also
subsequently informed the special master then responsible for the action that they had obtained
“mitochondrial testing” for C.J.K., and that the results of that testing might shed light on the nature
of his injuries. See Status Report, dated March 15, 2013 (ECF No. 46). Awaiting those results
caused further delay in the case’s adjudication.

While the results of that testing were pending, on July 31, 2013, Petitioners filed the expert
report of Dr. Levin – and thereby revealed the third iteration of Petitioners’ causation theory. As
discussed above, Dr. Levin posited that C.J.K. “was born with asymptomatic inborn errors of
metabolism which were triggered to become symptomatic in the form of immunological anomalies
by the cytokines released by the vaccinations he received on April 1, 2005.” Levin Rep. at 2. Thus
(and in contrast to the Amended Petition), Dr. Levin’s opinion renewed Petitioners’ earlier
argument that the April vaccines were significant, since he maintained they had triggered an initial
reaction, although he added that “[C.J.K.’s] symptoms returned with a re-challenge vaccination on
October 12, 2005, and remained significant until he was appropriately treated by his attending
physicians.” Id.

In the interim, Petitioners continued medical record collection, and were subsequently
ordered in the fall of 2013 to file an additional expert report once the mitochondrial testing results
had been obtained and filed. See Scheduling Order, dated Nov. 5, 2013 (ECF No. 57). The special
master’s order made clear that this expert report was specifically to address “how one or more
vaccine(s) received by [C.J.K.] can cause an autism spectrum disorder.” Id. at 1 (emphasis added).
Thus, as of the fall of 2013, it appears that there remained some belief (albeit possibly mistaken)

22
on the part of the special master presiding over the case at the time that Petitioners still sought to
connect C.J.K.’s autism to his vaccinations, despite their claims to the contrary the year before.

Another year and a half passed while additional genetic testing was performed, with
multiple extensions of time requested for the filing of the supplemental expert report. Eventually
the matter was assigned to me in September 2014. Almost eight months after that, Petitioners filed
Dr. Kinsbourne’s expert report, on May 30, 2015. However – and despite having plainly stated in
2012 (now three years earlier) that Petitioners were abandoning their autism injury claim, Dr.
Kinsbourne’s report directly identified autism as a likely “sequelae” of the significant aggravation
of C.J.K.’s condition brought on by his receipt of the flu vaccine in October 2005. Kinsbourne
Rep. at 5. The summation of his opinion was unequivocal in this regard, affirmatively opining that
“[C.J.K.] developed Autistic disorder soon after his influenza vaccination” due to oxidative stress
caused by vaccination. Id. at 3.

Over the next several months in 2015, Respondent obtained and filed expert reports from
Drs. McCandless, Wiznitzer, and Jones (ECF Nos. 87-89). In addition, Respondent filed an
amended Rule 4(c) Report. See Amended Rule 4(c) Report, dated October 2, 2015 (ECF No. 90).
Respondent’s experts attempted to address the breadth of Petitioners’ intertwined theories, and
thus offered opinions responding to (a) Dr. Kinsbourne’s causation theory regarding autism, (b)
the lack of evidence C.J.K. had a mitochondrial disorder, and (c) the assertion that C.J.K. had an
inborn metabolic error. Id. at 3-4.

I thereafter ordered Petitioners to file any supplemental expert report reacting to
Respondent’s experts’ opinions by January 15, 2016. See Scheduling Order, dated Nov. 2, 2015
(Docket Entry). After two requests for additional time, Petitioners filed their third expert report,
from Dr. Boles, on March 18, 2016. Like Dr. Kinsbourne, Dr. Boles also attributed C.J.K.’s autism
and/or developmental problems to a reaction to the flu vaccine that exacerbated C.J.K.’s alleged
underlying mitochondrial disorder, although he referenced many of C.J.K.’s other non-autism
symptoms as vaccine-caused as well. Boles Rep. at 7, 9-10 (emphasis added). On August 23, 2016,
Respondent filed a supplemental expert report from Dr. McCandless addressing Dr. Boles’s
conclusions. ECF No. 107.

By the fall of 2016, it appeared the matter was at long last ready for hearing, and I scheduled
this to occur in the following year, on December 5-6, 2017. See Prehearing Order, dated Dec. 13,
2016 (ECF No. 112). In accordance with that Order, Petitioners filed their opening prehearing brief
on May 5, 2017. See Prehearing Submission, dated May 5, 2017 (ECF No. 114) (“Pet.
Prehearing”). In it, they set forth yet another variation in Petitioners’ theory – now arguing
(contrary to the 2012 amended petition) that the 2005 vaccinations “significantly aggravated
[C.J.K.’s] pre-existing, but asymptomatic, mitochondrial disorder,” resulting in virtually all of
23
C.J.K.’s symptoms after those respective dates. Pet. Prehearing at 6. Although reference to autism
was nonexistent in this filing, Petitioners did propose that evidence of C.J.K.’s underlying
mitochondrial dysfunction (exacerbated by vaccines) had manifested in the form of “neurological
issues” (Id. at 9), and that within three weeks of his receipt of the flu vaccine C.J.K. was “no longer
following commands and he had delayed speech.” Id. at 9. The prehearing filing was vague in
specifying which experts would be testifying and on what topics, making it difficult to conclude
at this point that autism and/or developmental limits had in fact been completely eliminated as a
complained-of injury in this case.

Respondent’s pre-hearing brief, dated June 5, 2017, was accompanied by a separately-filed
request for a ruling on the record dismissing this action (ECF Nos. 115 and 116) (collectively,
“Mot.”).28 Noting that Petitioners’ claim was dependent on a finding that C.J.K. had a preexisting
metabolic disorder of some kind, characterized by mitochondrial dysfunction or disease,
Respondent argued that neither the record nor the expert reports submitted in support of this
concept supported it, and therefore asked for dismissal in light of a different case I had recently
decided on the papers in which an injured party’s alleged preexisting mitochondrial dysfunction
was, as here, central to the claim. Mot. at 12, citing Pope, 2017 WL 2460503.

After the completion of prehearing briefing (which included additional filings reacting to
Respondent’s motion),29 I held a status conference on October 4, 2017. See Scheduling Order,
dated October 5, 2017 (ECF No. 120). Taking into account Petitioners’ most recent expert reports
(Drs. Boles and Kinsbourne) along with Respondent’s Motion, and in light of the claim’s similarity
to other cases alleging that an underlying mitochondrial disorder had been exacerbated by vaccine
(and resulting in autism or developmental regression as an injury), I determined that a ruling on
the papers was preferable to a hearing as the most efficient means for resolving the case. Id. at 1.30
I also expressed the view that (as of that time) the claim likely lacked reasonable basis in light of
its deficiencies, and therefore even if a hearing were held, I would not be inclined to compensate
Petitioners’ counsel or experts for any work performed therein given my serious misgivings about
the claim’s substantive validity. Id. at 2.

28
Respondent’s actual motion (ECF No. 116) is a very short document that largely incorporates by reference the
detailed analysis set forth in his pretrial filing (ECF No. 115). References herein to “Mot.” shall therefore be to the
substantive contents of the latter.
29
Those filings are discussed below in the section of this Decision pertaining to the parties’ respective arguments.
30
I also noted in this Order that although Petitioners had formally stated that autism was not the complained-of injury
(anymore), they appeared to be trying to reclassify the case in order to evade the overwhelming weight of negative
precedent concerning autism injury claims. Id. at 1 n.1.

24
My October 5th Scheduling Order allowed Petitioners two weeks to determine how they
would like to proceed. Petitioners ultimately conceded that the financial risk of their counsel not
being compensated at a hearing outweighed their desire to have the matter heard, although they
reiterated their objection to the hearing’s cancellation. See Status Report, dated Oct. 20, 2017 (ECF
No. 121). I thereafter set the deadline of December 8, 2017, for both sides to file final briefs in
support of their positions, and each did so. The matter is ripe for resolution.

V. Arguments For and Against Dismissal

Respondent’s Motion

Respondent argues that the record does not allow for the conclusion that C.J.K. had any
kind of preexisting mitochondrial disease or dysfunction, drawing upon a detailed review of the
medical record to illustrate his points. Mot. at 5-11. In connection with this argument, Respondent
highlights my determination in Pope to dismiss on the record a case with a similar theory and
similar facts, and also involving some of the same experts, such as Dr. Kinsbourne. Mot. at 12.
There, as here, (a) the record did not establish the existence of a mitochondrial disorder, or
evidence of a post-vaccination reaction, and (b) the claimants lacked a reliable and persuasive
causation theory. Id. at 13-17. Respondent also maintains that Petitioners’ experts relied on facts
not corroborated by the record, but merely alleged by Mrs. Kreizenbeck. Id. at 17-22. And he
challenges the reliability of Dr. Kinsbourne’s opinion regarding the concept of oxidative stress
brought on by vaccination. Id. at 23-27.31

Petitioners’ Opposition

Petitioners responded to the dismissal motion on July 14, 2017 (ECF No. 118) (“Opp.”).
Petitioners deem their evidentiary showing “solid,” pointing out the disparity between C.J.K.’s
pre- and post-vaccination health. Opp. at 2. They maintain that it was “medically probable” that
C.J.K. did have an underlying (but initially asymptomatic) mitochondrial or immune dysfunction,
as corroborated by the diagnoses of several subsequent treaters like Drs. Gutpa or Natowicz. Id.
They further argue that proof of aggravation is found in the illnesses C.J.K. experienced after
receiving the vaccines. Id. at 2-4. Once his immune-compromised condition was understood and
his treatment adjusted, he experienced an improvement in his health. Id. at 3. Petitioners also,
however, maintain that the law relevant in the Vaccine Program does not require them to prove
the nature of C.J.K.’s immune deficiency “to perfection” – meaning that it does not matter whether

31
Respondent’s motion also takes aim at the fact that Petitioners’ alleged injury had been vaguely articulated, allowing
for the possibility that they continued to allege some kind of autism/developmental injury in this case despite their
claims to the contrary. Mot. at 1 n.1.

25
treaters and experts were correct in their assessment that C.J.K. suffered from mitochondrial
dysfunction - and that the overall picture afforded by a review of the medical record in its entirety
supports their claim. Id. at 4-5.32

Consistent with the Amended Petition, the Opposition to Respondent’s motion does not
discuss, or even mention, autism, regression, or developmental delay as C.J.K.’s claimed injury.
However, it relies on the facts and analysis set forth in their earlier prehearing brief, which did
contemplate that the vaccinations, at least initially, manifested themselves in a developmental
issue, and/or that such issues (which today have evolved into ADHD) are a consequence of
vaccination. See, e.g., Pet. Prehearing at 3, 4, 6, 7, and 9.

Petitioners also argue in favor of holding a hearing in this case. To that end, they note that
there was medical record evidence supporting components of their claim (for example, the
illnesses he experienced in 2005), and maintain that a hearing would assist them in developing
facts on disputed topics such as onset. Opp. at 3. Given that “[f]or every argument made,
Petitioners have made a counter-argument” (Opp. at 6), only a hearing could provide Petitioners
with a reasonable opportunity to “fully present evidence” supporting their claim. Id. at 1.

Respondent’s Reply

Respondent subsequently filed a reply in support of his motion. Reply, dated July 19, 2017
(ECF No. 119) (“Reply”). He maintains his prior position that preponderant evidence does not
support Petitioners’ contention that C.J.K. suffered from any kind of mitochondrial dysfunction,
as alleged – and that even if it were assumed otherwise, the record also did not support the
conclusion that any of the vaccines he received exacerbated it. Reply at 1-2. He also notes that
there were significant reliability problems with both Drs. Kinsbourne’s and Levin’s reports that
Petitioners have ignored, and that Respondent’s more comprehensive expert reports rebut
Petitioners’ expert contentions. Id. at 2-4. Petitioners also do not grapple with reliable record
evidence that is contrary to their theory, such as Dr. Wright’s determination that C.J.K. lacked an
immune deficiency. Id. at 5. All in all, Respondent reiterates his point that (consistent with Pope)

32
Notably, Respondent’s motion seems to have inspired Petitioners to fine-tune their theory yet again. Thus, the
causation theory articulated herein seems to have moved further away from the theories of Drs. Kinsbourne and Boles,
who attributed C.J.K.’s autism to the flu vaccine, and instead emphasizes the April and October vaccines containing
live viruses (flu, MMR, and varicella) as the source of the immune deficiency. Opp. at 3 (“[i]t is known that it is
extremely dangerous to give live vaccines to someone who has an inborn error of metabolism”). Petitioners cite to Dr.
Levin’s opinion for this assertion – although the Levin Report does not itself contain this language or make this specific
argument. See generally Levin Rep. Moreover, this theory would eliminate from consideration the flu vaccine C.J.K.
received – which was not a live virus vaccine. See Vaccine Information Statements (VIS): Inactivated Influenza VIS,
CDC, https://www.cdc.gov/vaccines/hcp/vis/vis-statements/flu html (last accessed on June 4, 2018) (“[t]here is no
live virus in flu shots.”).
26
I could rule in this case based upon the plain content of the expert reports filed, and thereby weigh
the sufficiency of Petitioners’ overall evidentiary showing without a hearing. Id. at 2, 5.

Final Memoranda

As noted above, after I determined that I would rule on the record in this case, I provided
both sides the opportunity to file final memoranda summarizing their positions. Each did so on
December 8, 2017 (ECF Nos. 126 (“Pet. Filing”) and 125 (“Rep. Filing”)).

Petitioners’ filing emphasized that the claim (as it stood in December 2017) sought only to
recover damages for injuries that had manifested “as an immune system anomaly, namely
hypogammoglobulinemia.” Pet. Filing at 1. Totally ignoring Dr. Kinsbourne’s opinion, Petitioners
stressed the illnesses C.J.K. experienced after his April and October 2005 vaccinations, and the
immune deficiency diagnosis he received, along with Dr. Levin’s opinion about C.J.K.’s purported
“inborn errors of metabolism,” bulwarked by Dr. Boles’s opinion about the nature of the error
(namely mitochondrial dysfunction). Id. at 2-5. Otherwise Petitioners reiterated their prior points
from earlier filings. Respondent’s final filing was even more succinct, and merely set forth a listed
summary of points previously made in his motion about the deficiencies in Petitioners’ overall
showing. Rep. Filing at 1-2.

VI. Applicable Legal Standards

A. Claimant’s Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table –
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).33
In this case, Petitioner does not assert a Table claim.

33
Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121,
124 (2003), aff’d, 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-
159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
27
For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344,
1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim (which is the kind of claim asserted in this matter), a petitioner must satisfy all
three of the elements established by the Federal Circuit in Althen v. Sec’y of Health & Human
Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a 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 showing of a proximate temporal relationship between
vaccination and injury.”

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, the
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory
must only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of
28
Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility . . . in many cases may be
enough to satisfy Althen prong one” (emphasis in original)). But this does not negate or reduce a
petitioner’s ultimate burden to establish his overall entitlement to damages by preponderant
evidence. W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations
omitted).

The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record – including conflicting opinions
among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011)
(not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions
against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health & Human
Servs., 100 Fed. Cl. 119, 136 (2011), aff'd, 463 F. App’x 932 (Fed. Cir. 2012); Veryzer v. Sec’y of
Health & Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29,
2011), mot. for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 F. App’x
765 (Fed. Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
29
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” Bazan v.
Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &
Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012),
aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human Servs., No.
11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d (Fed. Cl.
Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Standard for Significant Aggravation Claim

In this matter, Petitioners maintain that the relevant vaccines significantly aggravated a
preexisting condition in C.J.K. – his purported mitochondrial disease or dysfunction. Where a
petitioner so alleges, the Althen test is expanded, and the petitioner has additional evidentiary
burdens to satisfy. See generally Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144
(2009). In Loving, the Court of Federal Claims combined the Althen test with the test from
Whitecotton v. Sec’y of Health & Human Servs., 81 F.3d 1099, 1107 (Fed. Cir. 1996), which related
to on-Table significant aggravation cases. The resultant “significant aggravation” test has six
components, which are:

(1) the person’s condition prior to administration of the vaccine, (2) the person’s current
condition (or the condition following the vaccination if that is also pertinent), (3) whether
the person’s current condition constitutes a ‘significant aggravation’ of the person's
condition prior to vaccination, (4) a medical theory causally connecting such a
significantly worsened condition to the vaccination, (5) a logical sequence of cause and
effect showing that the vaccination was the reason for the significant aggravation, and (6)
a showing of a proximate temporal relationship between the vaccination and the
significant aggravation.

Loving, 86 Fed. Cl. at 144; see also W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1357
(Fed. Cir. 2013) (holding that “the Loving case provides the correct framework for evaluating off-
table significant aggravation claims”). In effect, the last three prongs of the Loving test correspond
to the three Althen prongs.

Within the Loving analysis, it is necessary to evaluate the likely natural course of an injured
party’s preexisting disease, in order to determine whether the vaccine made the petitioner worse
than he would have been but for the vaccination. Locane v. Sec’y of Health & Human Servs., 685
F.3d 1375, 1381-82 (Fed. Cir. 2012) (upholding special master’s determination that petitioner had
failed to carry her burden of proof in establishing that her preexisting injury was worsened by the
30
relevant vaccine); Hennessey v. Sec’y of Health & Human Servs., No. 01-190V, 2009 WL
1709053, at *41-42 (Fed. Cl. Spec. Mstr. May 29, 2009), mot. for review den’d, 91 Fed. Cl 126
(2010). In other words, the critical point of examination is “whether the change for the worse in
[petitioner’s] clinical presentation was aggravation or a natural progression” of the underlying
condition. Hennessey, 2009 WL 1709053, at *42. The Federal Circuit has upheld the
determinations of special masters that worsening was not demonstrated by a petitioner in
connection with establishing her overall preponderant burden of proof for a non-Table causation-
in-fact claim. See, e.g., Snyder/Harris v. Sec'y of Health & Human Servs., 553 F. App’x 994, 999-
1000 (Fed. Cir. 2014); Locane, 685 F.3d at 1381-82.34

The mere fact a vaccine might “trigger” a transitory negative response in an individual with
an underlying condition is not proof of worsening if that individual would be expected to
experience a similar course regardless. Faoro v. Sec’y of Health &Human Servs., No. 10-704V,
2016 WL 675491, at *27 (Fed. Cl. Spec. Mstr. Jan. 29, 2016), mot. rev. den’d, 128 Fed. Cl. 61
(Fed. Cl. Apr. 11, 2016) (finding that “the vaccinations would not have changed her clinical course
and thus, the vaccinations did not significantly aggravate her preexisting condition”). This point
was emphasized in a subcategory of Program cases involving the claim that a child’s Dravet
syndrome (a rare seizure disorder now understood to be caused by the SCN1A gene mutation) was
significantly aggravated by vaccination. Faoro, 2016 WL 675491, at *1. In such cases, special
masters have repeatedly determined that petitioners failed to show that a child’s expected outcome
would have been different but-for the vaccination – even though it was not disputed that the child’s
first major seizure had in fact been triggered by vaccination. Id. at *2 (“[a]lthough H.E.F.’s
vaccinations may have caused a low-grade fever or otherwise triggered her first seizure, neither
the initial seizure nor her vaccinations caused or significantly aggravated her Dravet syndrome and
resulting neurological complications”); see also Snyder/Harris v. Sec'y of Health & Human Servs.,
553 F. App’x 994 (Fed. Cir. 2014) (special master was not arbitrary in finding that petitioners’
expert failed to show that the child’s outcome would have been different had he not received the
vaccinations at issue).

C. Law Governing Factual Determinations

The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [] relevant medical and scientific evidence contained in the record,” including “any
34
This is consistent with the fact (well recognized by controlling precedent) that evidence of “worsening” relevant to
Respondent’s alternative cause burden may reasonably by evaluated by a special master in determining the success of
a petitioner’s prima facie showing. Snyder/Harris, 553 F. App’x at 1000, quoting Stone, 676 F.3d at 1380 (“no
evidence should be embargoed from the special master’s consideration simply because it is also relevant to another
inquiry under the statute”); see also de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1353 (Fed. Cir.
2008) (“[t]he government, like any defendant, is permitted to offer evidence to demonstrate the inadequacy of the
petitioner’s evidence on a requisite element of the petitioner’s case-in-chief”).
31
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,
condition, or death,” as well as “the results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the
events in question that was given at a later date, provided that such a determination is evidenced
by a rational determination).

Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health &
Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is
based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people
honestly report their health problems to those professionals; and (iii) medical professionals record
what they are told or observe when examining their patients in as accurate a manner as possible,
so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez
v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.
Apr. 10, 2013); Cucuras v. Sec'y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993
F.2d 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately
report the onset of their daughter’s symptoms. It is equally unlikely that pediatric neurologists,
who are trained in taking medical histories concerning the onset of neurologically significant
symptoms, would consistently but erroneously report the onset of seizures a week after they in fact
occurred”).

Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical
records are generally found to be deserving of greater evidentiary weight than oral testimony –
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd, 968 F.2d
1226 (Fed. Cir.), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v.
United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral

32
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).

However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon
common sense and experience, this rule should not be treated as an absolute and must yield where
the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19
(“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than
those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human
Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human
Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In
determining the accuracy and completeness of medical records, the Court of Federal Claims has
listed four possible explanations for inconsistencies between contemporaneously created medical
records and later testimony: (1) a person’s failure to recount to the medical professional everything
that happened during the relevant time period; (2) the medical professional’s failure to document
everything reported to her or him; (3) a person’s faulty recollection of the events when presenting
testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v.
Sec’y Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir.
2014). In making a determination regarding whether to afford greater weight to contemporaneous
medical records over contrary testimony, there must be evidence that this decision was the result
of a rational determination. Burns, 3 F.3d at 417.

D. Analysis of Expert Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Human Servs., 219 F.3d
1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to
the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339
(Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir.
1999)). “The Daubert factors for analyzing the reliability of testimony are: (1) whether a theory or
technique can be (and has been) tested; (2) whether the theory or technique has been subjected to

33
peer review and publication; (3) whether there is a known or potential rate of error and whether
there are standards for controlling the error; and (4) whether the theory or technique enjoys general
acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316 n.2 (citing Daubert,
509 U.S. at 592-95).

The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora (such as the district courts). Daubert factors are usually
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health
& Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742-45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec’y of Health & Human
Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for
review den’d, 108 Fed. Cl. 743 (2013), aff’d, 540 F. App’x 999 (Fed. Cir. 2013) (citing Cedillo,
617 F.3d at 1339).

E. Consideration of Medical Literature

Both parties relied on a few pieces of medical and scientific literature in this case in support
of their respective positions. I have reviewed all of the medical literature submitted in this case,
although my decision does not discuss each filed article in detail. Moriarty v. Sec’y of Health &
Human Servs., No. 2015-5072, 2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally
presume that a special master considered the relevant record evidence even though he does not
explicitly reference such evidence in his decision”) (citation omitted).

34
F. Determination to Resolve Case without Hearing

I have opted to decide entitlement in this case based on written submissions and evidentiary
filings, including the expert reports filed by each side. The Vaccine Act and Rules not only
contemplate but encourage special masters to decide petitions on the papers rather than via
evidentiary hearing, where (in the exercise of their discretion) they conclude that the former means
of adjudication will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d).
The choice to do so has been affirmed on appeal. D’Toile v. Sec’y of Health & Human Servs., No.
15-85V, 2018 WL 1750619, at *2 (Fed. Cir. Apr. 12, 2018); see also Hooker v. Sec’y of Health &
Human Servs., No. 02-472V, 2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016)
(citing numerous cases where special masters decided on the papers in lieu of hearing and that
decision was upheld). I am simply not required to hold a hearing in every matter, no matter the
preferences of the parties. See Hovey v. Sec’y of Health & Human Servs., 38 Fed. Cl. 397, 402-03
(1997) (special master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d
at 417.

Pope provides a good example (especially given its factual similarities to the present case)
of the considerations that have in prior cases persuaded me to resolve a matter on the record rather
than after hearing. There, a petitioner alleged that her son’s developmental regression and autism
were the result of a vaccine’s exacerbation of the child’s alleged underlying mitochondrial
disorder. Pope, 2017 WL 2460503, at *1. The child had experienced many post-vaccination
infections and illnesses, and the petitioner maintained that such a history of illness (plus reactions
to the vaccines that the record did not set forth but petitioner alleged had nevertheless occurred)
established exacerbation of the asymptomatic, underlying metabolic disorder. In addition, Pope
featured some testing that suggested the existence of mitochondrial dysfunction, as here – and the
petitioner also engaged Dr. Kinsbourne, who proposed a theory much like that offered in this case,
based on vaccines stressing an individual with an underlying metabolic disorder. Id. at *8 – 10.

After consideration of the expert reports and record, I opted to rule on the record, denying
entitlement and rejecting petitioner’s request for a hearing. Pope, 2017 WL 2460503, at *27. In so
doing, I noted that (a) I did not require live testimony to resolve a disputed fact, such as onset; (b)
some fact disputes mainly involved distinctions between what the record said and what fact
witnesses argued, and therefore were amenable to resolution on the papers; and (c) petitioner’s
experts over-relied on witness statements as opposed to the record itself. Id. at *26. I also
determined that the petitioner’s theory was too similar to theories already rejected in countless
prior autism injury cases, and that I was able to weigh the reliability and ultimate persuasiveness
of the expert opinions based on their written reports. Id.

35
ANALYSIS

Although Petitioners have affirmatively represented on several occasions that they no
longer claim that C.J.K.’s autism or developmental problems were vaccine-caused, both the
procedural history and the record – which includes the opinions of their own experts – belie their
representations to a degree. As discussed above, Petitioners first asserted that they were releasing
autism as the complained-of injury six years ago – but then, two years later, produced an expert
opinion in support of that same injury (from Dr. Kinsbourne).35 See, e.g., Kinsbourne Rep. at 4
(“[a]fter the [October 2005] vaccination [C.J.K.] developed Autistic disorder”). And it is far from
clear that Petitioners have actually abandoned their view that C.J.K.’s developmental problems
(whether deemed a plateau or regression) were vaccine-caused – as both they and their experts
continue to emphasize C.J.K.’s developmental issues as sequelae of a vaccine injury. See, e.g.,
Boles Rep. at 3, 9; Pet. Prehearing at 3, 4, 6, 7, and 9.

It is not surprising that Petitioners might wish to distinguish this action from the host of
others alleging autism as an injury – given the dismal track record of such claims. As noted above,
none of the OAP test cases resulted in outcomes favorable to the relevant petitioners. Moreover,
since the resolution of the OAP, no claimants have succeeded on a non-Table, causation-in-fact
claim connecting autism to receipt of a vaccine. See, e.g., Hardy v. Sec’y of Health & Human
Servs., No. 08-108V, 2015 WL 7732603, at *4-5 (Fed. Cl. Spec. Mstr. Nov. 3, 2015) (referencing
eleven autism claims unsuccessfully tried, plus six that were rejected (over the petitioners’
objections) without trial).

Other Program claimants have attempted to recast their claim that a vaccine caused an
autism injury as a claim that the vaccine precipitated some other initial form of injury, like an
encephalopathy (more often than not autoimmune in nature), that later indirectly produced
developmental problems due to the resulting neurologic injury. See, e.g., Cunningham v. Sec’y of
Health & Human Servs., No. 13-483V, 2016 WL 4529530 (Fed. Cl. Spec. Mstr. Aug. 1, 2016),
mot. for review den’d, slip op. (Fed. Cl. Jan. 25, 2017). But such efforts have been understood as
seeking to evade the weight of negative precedent involving autism claims. Cunningham, slip op.
at *7-8 (“[r]egardless of petitioner’s attempt to differentiate this case from other autism cases by
creating this second step, the Special Master rightfully classified this case as an autism case”).
Arguing that “neurologic” or other developmental problems (whether or not properly termed
autism) are the product of a vaccine-aggravated mitochondrial disease or disorder is not a
significantly different tactical approach. See, e.g., T.M. v. Sec’y of Health & Human Servs., No.
08-284V, 2016 WL 11087157, at *28 (Fed. Cl. Spec. Mstr. Aug. 9, 2016) (dismissing claim that

35
If the prior special master’s order to produce this report erred in assuming autism was still a component of
Petitioners’ claim, Petitioners made no effort to correct that misunderstanding.
36
vaccine caused mitochondrial disease/disorder resulting in developmental problems), mot. for rev.
den’d, 133 Fed. Cl. 78 (2017).

Nevertheless – there is no question that Program claimants may refine their allegations,
just as any civil action complainant might seek to conform their allegations to the evidence. See,
e.g., Nuttall v. Sec’y of Health & Human Servs., No. 07-810V, 2014 WL 643584, at *4 (Fed. Cl.
Spec. Mstr. Jan. 23, 2014) (“[p]etitioners have the right to develop their own case, and if needed,
to amend their petition and change their theory . . . .”).36 Accordingly, I am for purposes of my
analysis treating this matter as if Petitioners do not claim that C.J.K. experienced any
developmental problems at all due to vaccination – whether deemed autism, developmental
regression, or some other kind of neurologic deficiency with any behavioral symptoms. This leaves
only the theory that C.J.K. had some underlying “inborn error of metabolism” – whether in the
form of mitochondrial dysfunction, immunodeficiency, or something else - that was exacerbated
by the 2005 vaccines, resulting in a litany of harmful symptoms thereafter. As the below analysis
demonstrates, however, excising autism from this case in no way saves what remains of the claim.

I. Mitochondrial Disease vs. Dysfunction

As I previously noted in R.V. v. Sec’y of Health & Human Servs., No. 08-504V, 2016 WL
3882519, at *26 (Fed. Cl. Spec. Mstr. Feb. 19, 2016), mot. for review den’d, 127 Fed. Cl. 136 (Fed.
Cl. July 1, 2016), appeal dismissed, No. 16-2400 (Fed. Cir. Oct. 26, 2016), the concept of
mitochondrial disease or dysfunction includes a number of disorders affecting the body’s ability
to metabolize energy. It can manifest with a multitude of symptoms, some of which are
developmental in character, like autism – although autism has yet to be persuasively linked
causally to the condition. Id.

True mitochondrial disease is distinguishable from a lesser form of dysfunction. The
former (which may be more accurately described as “primary” mitochondrial disease) usually
presents with severe, clinically-recognized symptoms, and is often conclusively diagnosed by
genetic testing, while mitochondrial dysfunction (also called “secondary” mitochondrial disease)
can be the byproduct of a different disease or environmental trigger, or merely reflect a transient
metabolic problem. Haas at 1330; R.V., 2016 WL 3882519, at *26; Anderson v. Sec’y of Health &
Human Servs., No. 02-1314V, 2016 WL 8256278, at *24 (Fed. Cl. Spec. Mstr. Nov. 1, 2016), mot.
for review den’d, 131 Fed. Cl. 735 (2017), aff’d, 717 F. App’x 1009 (Fed. Cir. 2018). Examples
of mitochondrial disease include Leigh disease, a progressive and typically terminal condition

36
At a minimum, dropping autism or ADHD as a complained-of injury would mean that Petitioners could not recover
for damages relating to those conditions, but could otherwise (if they established entitlement to damages) recover for
the costs of treating C.J.K.’s immunodeficiency and the non-developmental sicknesses he has since experienced.

37
characterized by a subacute necrotizing encephalomyelopathy.37 The presence of mitochondrial
disease or dysfunction can be evaluated by consideration of the results of several lab tests, applied
to different diagnostic frameworks. See R.V., 2016 WL 3882519, at *26; Anderson, 2016 WL
8256278, at *7.

Secondary mitochondrial diseases have been linked to various underlying genetic disorders
(including copper-metabolism disorders, lysosomal disorders, peroxisomal disorders, pantothenate
kinase-associated neurodegeneration, holocarboxylase synthetase deficiency, molybdenum
cofactor deficiency, and neonatal hemochromatosis), as well, as medications, toxins, and aging.
Haas at 1331; Smeitink at 12. The diagnostic evaluation for secondary mitochondrial dysfunction
is essentially the same as that conducted for primary mitochondrial disease (centering on a multi-
tiered interpretation of clinical, imaging, metabolic screening, and biochemical markers). See
generally Haas.

I have issued decisions in several cases in which petitioners claimed a child possessed an
undiscovered or asymptomatic mitochondrial disorder that had been aggravated by vaccination. In
each instance, I have not found that any secondary form of mitochondrial disease was successfully
established. See, e.g., Anderson, 2016 WL 8256278, at *24-25 (finding petitioner did not suffer
from a secondary mitochondrial disorder where overall health history and medical testing did not
support such a conclusion based on the dialogistic guidelines); R.V., 2016 WL 3882519, at *33-34
(finding the same). Other special masters have reached the same conclusion. Bast v. Sec’y of Health
& Human Servs., No. 01-565V, 2012 WL 6858040 (Fed. Cl. Spec. Mstr. Dec. 20, 2012)
(application of the Bernier criteria for mitochondrial dysfunction did not support a preponderant
finding of a mitochondrial disorder), mot. for review den’d, 117 Fed. Cl. 104 (2014), appeal
dismissed, 579 F. App’x 1001 (Fed. Cir. 2014). Common to all such cases were the following:

 the petitioners sought to identify a metabolic disorder they alleged had predated
vaccination - based on testing performed long after the time of vaccination;

 no contemporaneous treater ever proposed at the time of vaccination, or even soon
thereafter, based on any observed changes in the relevant child’s health or other
clinical indicia, that the child might be suffering from any form of mitochondrial
disorder;

 the child in question was never diagnosed with a known primary mitochondrial
disease – leaving only the possibility that a secondary form of mitochondrial
disorder was present; and

37
Dorland’s at 538.
38
 testing performed on the child rendered ambiguous and inconclusive results, with
some results supporting the diagnosis and others undermining it, making it
impossible to conclude “more likely than not” that the child did have a secondary
mitochondrial disease.

There are hardly any cases, by contrast, where a claimant obtained an entitlement award
based on the allegation that a child’s preexisting mitochondrial dysfunction was aggravated by a
vaccine – and those rare instances that do exist are facially inapposite. For example, in Poling v.
Sec'y of Health & Human Servs., No. 02–1466V, 2008 WL 1883059 (Fed. Cl. Spec. Mstr. Apr.
10, 2008)38, the child in question (who was later diagnosed with mitochondrial disease) had
received several vaccines, and then within 48 hours developed a high fever that became low-grade
over the next several days, along with inconsolable crying, sleeplessness, and significant,
noticeable motor problems memorialized in the medical record that worsened over the next several
days. Such facts are completely distinguishable from the present. Moreover, Poling involved a
Table claim – and therefore the fact that Respondent conceded entitlement therein, based on
Petitioner’s evidentiary satisfaction of the Table elements, did not amount to a concession that
causation had been establishe

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/4300738. Public record. Not legal advice.