Kreizenbeck v. Secretary of Health and Human Services

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 established based on the criteria relevant to a non-Table case like the present.

In Paluck v. Sec'y of Health & Human Servs., 786 F.3d 1373 (Fed. Cir. 2015), the Federal

Circuit affirmed a Court of Federal Claims’s determination that a special master erred in denying

compensation to petitioners claiming (in a non-Table case) that the MMR, varicella, and

pneumococcal vaccines significantly aggravated their child’s mitochondrial disease, resulting in

severe neurodegeneration with evidence of developmental problems. However, the child’s

underlying mitochondrial disease diagnosis was not a contested fact (as is the case here). Paluck

is also factually distinguishable for other reasons. The vaccinated child (a one-year-old) had

experienced a persistently high fever in the two to seven days immediately after receiving the

vaccines, and was soon thereafter diagnosed with possible neurologic problems confirmed by MRI

results, among other things. Paluck, 786 F.3d at 1376. Nothing so severe is evident from the

present evidentiary record.

II. Petitioners Have Not Shown that C.J.K. Had Any Mitochondrial Dysfunction

Petitioners were tasked with establishing that C.J.K. possessed some kind of underlying

mitochondrial dysfunction that was aggravated by vaccination. Preponderant evidence does not

support their contention.

38

The Poling article referenced in Drs. Kinsbourne’s and Jones’s reports involves the same child as the Poling case.

39

First, I find that C.J.K. did not suffer from a “primary” mitochondrial disease. The best

evidence that he had any kind of mitochondrial dysfunction comes from the treating records of Dr.

Natowicz, and he was only willing to propose that C.J.K. was experiencing at best a “secondary

phenomenon,” or the secondary kind of mitochondrial disease. See Ex. 33 at 6-7. Dr. Boles’s report

could be read in places to suggest the contrary, but he was inconsistent in his use of terms, and

ultimately opined that C.J.K. suffered from a “probable mitochondrial disorder” given the

“absence of proof.” Boles Rep. at 9. The record otherwise does not reveal that C.J.K. suffered from

the kind of clinically recognized disease or illness that would be of sufficient progressive severity

to constitute primary mitochondrial disease, as Dr. Jones’s report makes clear when comparing

testing results for C.J.K. with those for the child in Poling. Jones Rep. at 3-4.

Second, I do not find that preponderant evidence supports the conclusion that C.J.K.

suffered from even a secondary form of mitochondrial dysfunction or some other condition that

would negatively impact immune system function. Dr. McCandless has provided a persuasive

close reading of the testing performed on C.J.K., and as he points out the results, when evaluated

as a whole, do not support the conclusions urged by Petitioners. The sole positive fibroblast test

result is insufficient, by itself, to support Petitioners’ favored diagnosis. Indeed, Dr. Natowicz’s

diagnosis is itself hedging and tentative in character – and I need not accept it wholesale simply

because he was one of C.J.K.’s treaters. See, e.g., R.V., 2016 WL 3882519, at *33-34.39

Another basis for questioning whether preponderant evidence supports the conclusion that

C.J.K. had a secondary mitochondrial disease arises from the clinical standards used for

determining if a person suffers from such a condition. In other cases, I have discussed the different

relevant diagnostic criteria. See, e.g., T.M., 2016 WL 11087157, at *30; Anderson, 2016 WL

8256278, at *24. Although those criteria have evolved, they generally require evidence that several

different elements are present – some of which are established with testing, while others reflect

clinical symptoms. It is evident here, by contrast, that C.J.K. only demonstrates (a) slightly

elevated serum 3, (b) a slightly positive result in only one of several fibroblast tests, and (c) some

evidence of other objective criteria (i.e. alleged muscle tone loss40, gastrointestinal problems). But

39

Although my primary grounds for giving Dr. Natowicz’s diagnosis less weight are due to its somewhat tentative

nature, plus Dr. McCandless’s more persuasive interpretation of the same data points, I also observe that Dr.

Natowicz’s diagnosis was made eight years after the vaccinations in question. Because Petitioners allege C.J.K.

suffered from a metabolic disorder, such long after-the-fact testing has somewhat less probative value than

contemporaneous testing performed closer in time to vaccination or injury onset. Indeed, and as noted in other cases

involving alleged mitochondrial disorders, testing performed on different days can produce wildly divergent results.

See, e.g., 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). It is

therefore difficult to conclude that just because testing on C.J.K. produced some results supportive of a secondary

mitochondrial disease diagnosis in 2013, that these findings can be reasonably applied to 2005.

40

Hypotonia, or low muscle tone, can be a clinical indicia of a mitochondrial disorder. See, e.g., R.V., 2016 WL

3882519, at *12. Mrs. Kreizenbeck’s affidavit alleges C.J.K. displayed loss of muscle tone after his receipt of the flu

40

Dr. McCandless persuasively set forth the many other relevant clinical criteria that were not

satisfied by testing performed on C.J.K., referencing valid medical support for his views.

McCandless Rep. at 3, citing Smeitink and Haas. He also noted that even the few positive results

suggestive of secondary mitochondrial disease were arguably of less significance than Petitioners

urge. Dr. Boles, by contrast, did not set forth the criteria he was applying, and did not persuasively

rebut Dr. McCandless’s points.

There are scattered bits of reliable evidence in the record that C.J.K. might have suffered

from some secondary form of mitochondrial disorder – but it mainly comes in the form of treater

opinions that upon close inspection do not support the diagnosis all that strongly, since they rely

on ambiguous testing data points based in turn on mildly elevated results. On the other hand, Dr.

McCandless has provided an exhaustive review of the record, and his conclusions (bulwarked by

his demonstrated familiarity with this kind of testing) are trustworthy and persuasive – and that

opinion is better supported by the record. The record does not support the conclusion that it is

“more likely than not” that C.J.K. suffered from a secondary mitochondrial disease or dysfunction.

III. Petitioners Have Not Demonstrated C.J.K. Experienced Vaccine-Caused

Aggravation of an Underlying Metabolic Disorder or Secondary Mitochondrial

Disease.

Even if my determination above were in error, and Petitioners were found to have offered

sufficient preponderant evidence making it more likely than not that C.J.K. had a secondary form

of mitochondrial disease, Petitioners’ claim would founder on something more fundamental: their

inability to establish that C.J.K.’s preexisting metabolic condition was aggravated by any of the

vaccines he received.

Petitioners argue that merely because C.J.K. was healthy before his April 2005

vaccinations, but thereafter began to experience recurrent infections and then later manifested

“immune system problems,” that they have met this element of the Loving test. Pet. Prehearing at

7-8. But this is no different from arguing that a mere temporal relationship between vaccine and

injury satisfies a petitioner’s burden of proof – a proposition flatly rejected by the Federal Circuit.

See, e.g., LaLonde v. Sec’y of Health & Human Servs., 746 F.3d 1334, 1341 (Fed. Cir. 2014) (“[a]

temporal correlation alone is not enough to demonstrate causation”). The law relevant to

significant aggravation claims requires much more than that – petitioners must demonstrate that

the underlying condition was worsened beyond what would be expected to occur otherwise/absent

vaccination. Hennessey, 2009 WL 1709053, at *41-42.

vaccine in October 2005. Ex. 42 at 2 ¶8. However, the medical records do not corroborate this assertion – although

Dr. Boles relied on it in his report. Boles Rep. at 3, 4.

41

The record in this case does not reflect circumstances in which a vaccine made a child with

a preexisting metabolic condition markedly worse. It does not disclose any instances of a close-in-

time reaction, and there is a lack of contemporaneous treater evidence or test results demonstrating

the purported reaction was occurring in 2005 or in early 2006. To the extent Petitioners maintain

that the vaccines later triggered some kind of immune deficiency, Dr. Gupta’s 2008 diagnosis (Ex.

32 at 2) is conclusory and not supported by filed test results, while also being undercut by Dr.

Wright’s 2006 determination that C.J.K. did not suffer from immune dysfunction. Ex. 6 at 3-4.

The overall record better demonstrates that Petitioner received some childhood vaccines in April

2005, suffered illnesses that similarly-situated infants experience (respiratory or gastrointestinal

infections), and then later that fall received a flu vaccine – all without truly alarming incident. I

cannot conclude from such a record that Petitioner’s purported metabolic disorder produced a

worse outcome for him than would be expected, simply due to the vaccines he received. See, e.g.,

Hennessey, 2009 WL 1709053, at *41-52.

I also do not find persuasive Petitioners’ efforts to supplement the contemporaneous record

with assertions from Mrs. Kreizenbeck about changes she purportedly observed in C.J.K. post-

vaccination, or her reporting of fever-oriented reactions that were closely followed by significant

changes. Her claims of vaccine reactions do not find any corroboration in the record – and it is

well understood in the Program that contemporaneous records are deemed accurate. See Murphy,

23 Cl. Ct. at 733.

IV. Petitioners Have Not Established a Reliable or Persuasive Causation Theory that

Vaccines Could Exacerbate an Underlying Mitochondrial Disorder.

None of Petitioners’ experts (some of whom unquestionably offered opinions intended to

bolster Petitioners’ allegedly-abandoned arguments that C.J.K.’s vaccines caused autism or

developmental injury) provided sufficiently reliable and persuasive opinions to support the

conclusion that vaccines could cause exacerbation of an existing secondary mitochondrial disease.

The most current iteration of Petitioners’ claim leans heavily on the opinion of Dr. Levin.

Facially, however, this opinion (a two-page letter) is the least effective of the three reports filed in

this case by Petitioners, given its conclusory nature. See generally Ex. 28. For the assertion that

C.J.K. suffered from “inborn errors of metabolism,” Dr. Levin relies heavily on the

hypogammaglobulinemia diagnosis of Dr. Gupta in 2008 (Levin Rep. at 1) – a diagnosis that not

only was preceded in 2006 by the contrary diagnosis of Dr. Wright (Ex. 6 at 3-4), but also which

is itself too perfunctory to give substantial weight, given the absence of corroborative medical

records revealing the basis for Dr. Gupta’s conclusions. Dr. Levin otherwise makes broad

assertions about the capacity of vaccine-induced cytokines to stimulate the immune system

pathologically that he offers little support for beyond his own ipse dixit, and which I do not deem

42

reliable on their face.41 If Dr. Levin meant to expand on his conclusory views at a later date, he

has missed his chance; Petitioners could have filed a supplemental report from him in the nearly

five years since his report was first prepared, but they never did so.

Dr. Kinsbourne’s opinion suffers from similar persuasiveness problems, given the factual

assumptions and unreliable assertions underlying his conclusions. There are legitimate questions

surrounding Dr. Kinsbourne’s expertise to opine on the matters at issue at all, given his lack of

direct experience with metabolic disorders.42 But even putting qualifications aside, Dr.

Kinsbourne’s report on its face makes assertions about the capacity of vaccines to cause oxidative

stress sufficient to result in disease or immune dysfunction that are weakly grounded in reliable

science – deficiencies that have been recognized in other cases, when he has offered similar

opinions. See, e.g., Pope, 2017 WL 2460503, at *8 (observing that Dr. Kinsbourne failed to explain

“how much oxidative stress is generated by vaccination generally, . . . [or] what level of oxidative

stress is necessary to cross the “tipping point” to cause clinical disease”); Dwyer v. Sec’y of Health

41

I have in other cases questioned the theory that a vaccine-induced cytokine storm or cascade can sustain itself long

enough (e.g., more than a few weeks) to precipitate harm to an individual at a later date. See, e.g., Carda v. Sec’y of

Health & Human Servs., No. 14-191V, 2017 WL 6887368 (Fed. Cl. Spec. Mstr. Nov. 16, 2017); Dean v. Sec’y of

Health & Human Servs., No. 13-808V, 2017 WL 2926605 (Fed. Cl. Spec. Mstr. June 9, 2017), motion for rev. den’d,

slip op. (Fed. Cl. Sept. 26, 2017).

42

As a pediatric neurologist, Dr. Kinsbourne has expertise in testifying about autism – but barely sufficient expertise

to opine on the interplay between vaccines and underlying metabolic deficiencies sufficient (after prompting by a

vaccine) to produce a neurologic injury like autism. He is also not an expert on the topic of mitochondrial disease or

metabolic disorders, a central aspect of Petitioners’ theory.

Dr. Kinsbourne has often testified in Vaccine Program cases on behalf of petitioners in a variety of contexts. See,

e.g., Hammitt v. Sec’y of Health & Human Servs., No. 07-170V, 2010 WL 3735705, at *8 (Fed. Cl. Spec. Mstr. Aug.

31, 2010) (alleging that the petitioner’s DTaP vaccination caused her Dravet Syndrome), on reconsideration, 2011

WL 1135878 (Fed. Cl. Mar. 4, 2011), mot. for review den’d, 98 Fed. Cl. 719 (2011), aff’d, 676 F.3d 1373 (Fed. Cir.

2012). But other special masters have observed deficiencies in his capacity to opine on certain topics, due in part to

his lack of clinical expertise in the past 30-plus years:

A significant concern regarding Dr. Kinsbourne's reliability as an expert witness is that he has not

maintained a “hospital based clinical pediatric neurology practice” since 1981. . . . Dr. Kinsbourne's

testimony reflected his lack of recent clinical practice. His testimony was highly generalized and lacked any

grounding in practice. While Dr. Kinsbourne may keep current with medical literature . . . his testimony

amounts to little more than repeating snippets from that literature.

He has no current experience or context outside of “behavioral aspects” of pediatric neurology with which

to apply, question, or discuss an article's teachings. . . . Dr. Kinsbourne does not publish, research, teach,

counsel, attend meetings or conferences, or have any special training in the field of genetics. . . . Nor does

Dr. Kinsbourne have any “experience or training or knowledge in clinical genetics, molecular genetics, and

neurogenetics.” . . . The fact that for the past twenty-five years Dr. Kinsbourne has not focused his practice,

research or teachings in the field of seizure disorders, and that Dr. Kinsbourne has no expertise in the field

of genetics significantly limited his ability to offer reliable, persuasive, and cogent testimony in this case.

Hammitt, 2010 WL 3735705, at *8 (internal citations omitted).

43

& Human Servs., No. 03-1202V, 2010 WL 892250, at *163 (Fed. Cl. Spec. Mstr. Mar. 12, 2010)

(“[w]itnesses with far better qualifications in research into neurodegenerative diseases and

oxidative stress established that the cellular processes Dr. Kinsbourne described do not work the

way he asserted”). He also relies heavily on Mrs. Kreizenbeck’s unsubstantiated allegations of a

vaccine reaction. Kinsbourne Rep. at 1-2. And Dr. Kinsbourne’s opinion focused on C.J.K.’s

autism/developmental injuries – issues which Petitioners maintain are no longer relevant to their

claim.43

Dr. Boles’s report was the most reliable of the three filed by Petitioners – but only because

it was largely devoted to establishing the propriety of C.J.K.’s secondary mitochondrial disease

diagnosis, a topic upon which Dr. Boles was eminently qualified to opine. But, as noted above, I

find (based on a comparison of Dr. Boles’s report with those of Drs. McCandless and Jones, as

well as consideration of the relevant portions of the medical record) that he did not succeed in

persuasively establishing that C.J.K. more likely than not did have a metabolic disorder that could

have been exacerbated by vaccines. Moreover, even if my determination in this respect is wrong,

the other components of his report bearing on causation are less well-founded. The aspects of Dr.

Boles’s opinion dealing with vaccine exacerbation not only exceeded his expertise somewhat, but

were conclusory and unsubstantiated by even the limited medical literature that Dr. Levin

offered.44 And Dr. Boles placed too much emphasis on Mrs. Kreizenbeck’s uncorroborated

43

These parts of Dr. Kinsbourne’s opinion are equally unpersuasive and unreliable. For example, Dr. Kinsbourne

associates autism or developmental problems with mitochondrial dysfunction. Kinsborne Rep. at 3. But this assertion

finds minimal scientific support, at least based on the literature filed in this case. At best, he offers a single study (J.

Shoffner, et al., Fever Plus Mitochondrial Disease Could Be Risk Factors for Autistic Regression, 25 J. Child Neurol.

429 (2009) (filed as Ex. 64) (“Shoffner”)), and the Poling case report, to bridge this analytical gap between vaccination

and autism (see Kinsbourne Rep. at 3-4), but neither are able to do the work assigned.

Poling, for example, describes a single child later diagnosed with mitochondrial disease. The child had received

several vaccinations, 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 that worsened over

the next several days. Poling at 1. There, not only was the mitochondrial disease diagnosis supported, but the reaction

to the vaccines was immediate, documented, and facially undeniable – unlike in this case.

Shoffner, while a legitimate piece of scientific literature, is also unhelpful given the present facts. That study looked

at the relationship between autistic regression in patients with mitochondrial dysfunction and fever – not vaccination

and fever and/or autism. Shoffner at 1. The evidence that C.J.K. regressed after any of the vaccines he received is

fairly weak, by contrast, if not nonexistent. See Ex. 8 at 1; Ex. 4 (Part 3) at 13, 20; Ex. 9 at 2-4; Ex. 11 at 1-9. In

addition, as Shoffner succinctly acknowledges, “[a]utistic regression was not associated with vaccination.” Shoffner

at 3, 4 (“[i]n our patients with mitochondrial disease and autistic spectrum disorders, the vaccines did not appear

related to the neurologic regression.”).

44

I recognize that petitioners are not required to offer medical or scientific literature. But when a petitioner seeks to

advance causation theories based on conclusory arguments that either lack substantiation from a credible and

persuasive expert report, or reflect conclusory expert statements that are not themselves backed up with reliable

scientific support, the absence of such evidence (which could corroborate or advance their theory) can be noted in

evaluating if the petitioner has carried his burden of proof.

44

allegations of C.J.K.’s vaccine reactions in opining that proof of exacerbation was established,

further diminishing the reliability of his opinion. Boles Rep. at 3; see, e.g., Hooker, 2016 WL

3456435, at *28 (reliance on incorrect assumption of fact causes expert to lose evidentiary value).

Respondent’s experts, by contrast, effectively rebutted the concept that vaccines could

negatively interact with a metabolic disorder, while persuasively refuting Petitioners’ contentions

that C.J.K. had any kind of mitochondrial disease or metabolic disorder. Dr. Jones in particular -

an expert in redox biology, unlike Dr. Kinsbourne - cogently demonstrated that Dr. Kinsbourne’s

theories about possible mechanisms by which a vaccine could stress an individual’s underlying

metabolic disorder sufficient to cause harm were outdated and unreliable. Jones Rep. at 5-6. This

is not the first time this kind of theory has been persuasively rebutted by Dr. Jones. See, e.g., Bast,

2012 WL 6858040, at *6 (Dr. Jones “testified persuasively that the commonly induced but

transient state of oxidative stress . . . cannot produce the type of permanent damage alleged”).

Additionally, the Federal Circuit’s decision in Paluck does not compel the finding that Dr.

Kinsbourne’s causation theory here was legally sufficient to meet Petitioners’ burden, as

Petitioners maintain. See Pet. Prehearing Brief at 8-10. Besides involving far more extreme facts

than herein (as noted above), in Paluck the Federal Circuit made no findings whatsoever with

respect to the reliability of the petitioners’ medical theory – nor was it asked to by either party. By

contrast, there are numerous apposite cases where the reliability of the medical theory connecting

autism to mitochondrial disease has been successfully challenged. See, e.g., Bast, 2012 WL

6858040, at *25-39; R.V., 2016 WL 3882519, at *10-25.

The causation theory presented herein is strikingly similar to theories presented – and

rejected – in many more previously-resolved cases. See, e.g., Hardy, 2015 WL 7732603, at *4-5

(petitioners failed to demonstrate that DTaP vaccine caused or significantly aggravated underlying

mitochondrial disease resulting in ASD); R.V., 2016 WL 3882519, at *42, mot. for review den’d,

127 Fed. Cl. 136 (2016) (factual record did not support contention that child suffered from a

mitochondrial disease, or that the vaccine at issue had a causal connection to the development of

ASD); Miller v. Sec’y of Health & Human Servs., No. 02-235V, 2015 WL 5456093 (Fed. Cl. Spec.

Mstr. Aug. 18, 2015) (petitioners failed to demonstrate that several childhood vaccines caused

encephalopathy or aggravated underlying mitochondrial disease/dysfunction); Lehner v. Sec’y of

Health & Human Servs., No. 08-554V, 2015 WL 5443461 (Fed. Cl. Spec. Mstr. July 22, 2015)

(petitioners failed to demonstrate that flu vaccine resulted in autoimmune encephalitis).

Petitioners’ experts herein offered opinions no more compelling than those who went before.

45

V. Petitioners Cannot Satisfy the Althen Prongs.

Give the above, it is evident that Petitioners have not met their burden under the analysis

set forth in Althen (and subsumed in Loving for claims of significant aggravation45) for proving a

causation-in-fact claim. With respect to the first, “can cause” prong, Petitioners have not provided

sufficient reliable evidence, in the form of expert opinions or otherwise, that any of the vaccines

C.J.K. received could exacerbate an underlying metabolic or mitochondrial disorder, resulting in

immune dysfunction (or developmental problems). The expert views offered in support of these

theories are thin and inadequately substantiated with either demonstrated expert knowledge of the

subject, or scientific and medical literature bridging the gap between expert and theory. Certainly

no direct evidence has been offered to establish the capacity of the vaccines at issue to interact

with a metabolic disorder, but the circumstantial evidence offered is also insufficient.

Next, Petitioners have failed to make a preponderant case that C.J.K. did experience

vaccine-caused immune dysfunction. There is some record support for the immune dysfunction

diagnosis in the form of Dr. Gupta’s 2008 diagnosis, but it is conclusory - and comes after an

equally-valid diagnosis from Dr. Wright in 2006 finding no such dysfunction. Petitioners

otherwise failed to offer any explanation for why Dr. Gupta’s diagnosis is more credible than Dr.

Wright’s earlier diagnosis. The evidence supporting the secondary mitochondrial disease

allegations is found in Dr. Natowicz’s 2013 work-up, and it has more reliability – although, for

the reasons highlighted by Dr. McCandless, the probative value of that diagnosis is fairly low when

the evidence is viewed in totality. There is also no contemporaneous medical record evidence that

C.J.K. suffered any reaction close-in-time to the April or October vaccinations, and nothing in the

record that would circumstantially support the conclusion that a vaccine-induced process had

45

Because I have concluded that Petitioners could not demonstrate several factual predicates of their significant

aggravation claim (i.e., that C.J.K. had an underlying secondary mitochondrial disease, or that the vaccines he received

did in fact aggravate it), I do not herein provide a point-by-point discussion of each Loving prong. To some extent,

this reasonably flows from the fact that if a vaccine cannot be established to be causal of an injured person’s condition

(here, because a predicate of the claim is an unsubstantiated mitochondrial disease), then there is no need to evaluate

if the person’s underlying condition was worsened. Hennessey v. Sec’y of Health & Human Servs., No. 01-190V, 2009

WL 1709053, at *42 (Fed. Cl. Spec. Mstr. May 29, 2009), mot. for review den’d, 91 Fed. Cl 126 (2010) (“[i]n most

off-Table significant aggravation cases, it may be more logical to consider the last three Loving factors [the Althen

factors] first”).

I note, however, that Petitioners have largely failed to offer preponderant evidence for a significant Loving element:

that C.J.K.’s underlying mitochondrial disease was worsened by vaccination. Hennessey, 2009 WL 1709053, at *42.

The record does not reveal worsening; the “before and after” argument that Petitioner’s illnesses manifested post-

vaccination is not sufficient to satisfy this test. See 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 relevant vaccine). And Petitioners’ three experts did

little in their reports to make scientifically-reliable arguments regarding what worsening would look like, or how to

compare outcomes of individuals with underlying metabolic disorders who received vaccines versus those who did

not.

46

begun at either time. The infections C.J.K. suffered do not appear at the time to have been viewed

by treaters as out of the ordinary for a child of his age. See, e.g., Anderson, 2016 WL 8256278, at

*19. And Mrs. Kreizenbeck’s allegations that she observed immediate post-vaccination reactions

are uncorroborated by the contemporaneous medical records.

Finally, with respect to the reasonableness of the timeframe in which C.J.K.’s vaccine

injury occurred, Petitioners produced medical records (corroborated by Mrs. Kreizenbeck’s

affidavit) that C.J.K. began having health issues approximately three weeks after his flu

vaccination in December 2005. See, e.g., Ex. 8 at 1; Ex. 4 (Part 3) at 13, 20; Ex. 9 at 1-4; Ex. 11

at 1-19. However, among the first symptoms that he presented with were developmental issues -

which as stated above have not been found to be associated with vaccination, and which I am

(consistent with Petitioners’ stated intent) treating for present purposes as not alleged to be

vaccine-caused. In addition, there is contrary evidence suggesting that C.J.K.’s developmental

problems first manifested as communication or attention issues as early as the summer of 2005,

long before that vaccination. See Ex. 4 (Part 3) at 12; Ex. 8 at 1, 7; Ex. 4 (Part 1) at 20-21; Ex. 9

at 2-4; Ex. 11 at 4; Ex. 26 at 1. And there is even less evidence of a reaction after the April 2005

vaccinations. The after-the-fact 2008 immunodeficiency diagnosis cannot be linked to a 2005

vaccination event simply on the basis of C.J.K.’s different illnesses that summer, in the absence of

reliable and persuasive evidence contemporaneous with those illnesses at the time (whether in the

form of treater opinion or test result) that would suggest the illnesses were caused by the immune

deficiency. This record simply does not support the conclusion that any of C.J.K.’s various alleged

vaccine injuries began in a medically reasonable period after the vaccines he received – and

Petitioners’ experts provided no reliable explanation for the temporal period in which his alleged

immune dysfunction would be expected to manifest, or its likely course.

VI. This Case was Properly Resolved without a Hearing.

In ruling on the record, I am declining Petitioners’ request that I conduct a hearing. The

choice of how best to resolve this case is a matter that lies generally within my discretion, but

given Petitioners’ objections I shall explain my reasoning.

Prior decisions have recognized that a special master’s discretion in deciding whether to

conduct an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to “afford[] each

party a full and fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 400-01 (citing Rule

3(b)). But that rule also includes the obligation of creation of a record “sufficient to allow review

of the special master’s decision.” Id. Thus, the fact that a claim is legitimately disputed, such that

the special master must exercise his intellectual faculties in order to decide a matter, is not itself

grounds for a trial (for if it were, trials would be required in every disputed case). Special masters

47

are expressly empowered to resolve fact disputes without a hearing – although they should only so

act if a party has been given the proper “full and fair” chance to prove their claim.

In this case, several factors counseled against holding a hearing. As Respondent pointed

out in his motion, Petitioners’ claim closely parallels numerous other cases asserting that an

underlying secondary mitochondrial disease was exacerbated by vaccines and thereby causing

injury. This remains so even if the “downstream” developmental or autism injuries initially alleged

herein are ignored, leaving only the contention that an immune deficiency was the product of

exacerbation of C.J.K.’s underlying condition. But the core components of such a claim – that

vaccines could impact a possible, but unproven, mitochondrial condition – have been not only

rejected after trial, but rejected without hearing. See Pope, 2017 WL 2460503, at *26-27. The

congruence of Petitioners’ theory and its factual predicates with numerous, previously-rejected

variations on the same theme counseled against expending the time and effort necessary for a

hearing.46

The specific expert opinions offered herein also did not suggest the need for live testimony

in order to probe the bases for their opinions. Where experts provide equally plausible readings of

a record, or opine on a matter of notable complexity, hearing their testimony live may well aid the

special master in weighing the evidence. But this is not always the case – even novel causation

issues may be resolved on the papers if deficiencies in the relevant theory can be identified based

on careful reading of the relevant reports. See D’Toile, 2018 WL 1750619, at *2 (Fed. Cir. Apr.

12, 2018) (upholding determination on the record that flu vaccine had not been demonstrated to

cause narcolepsy, even though issue was novel and had not been tried in the Program). Given my

familiarity with the concepts at issue raised by both sides’ expert reports, I was able to ascertain

the weaknesses in Petitioner’s theory based solely on the reports filed.

Admittedly, there is conflict in the record between Dr. Boles’s interpretation of the

mitochondrial function testing (which he deems supportive of the conclusion that C.J.K. had a

mitochondrial “disease”), and Dr. McCandless’s (which he argues does not). In some cases, this

kind of dispute among similarly-qualified experts would be grounds for a hearing, so that

credibility could be weighed and experts cross-examined. But the fact that experts dispute a point

does not inexorably result in a hearing in all cases. I have found that Respondent’s interpretation

of the record is more persuasive. On its face, that record reveals that Dr. Natowicz himself – a

primary treater with agreed expertise in mitochondrial diseases – felt that C.J.K.’s dysfunction was

46

The decision not to hold a hearing based upon the similarity of the claim to previously-litigated claims is not

something that would only ever inure to Respondent’s benefit. The opposite circumstances – where a petitioner

asserted a claim that has repeatedly succeeded in the past (for example, the allegation that the flu vaccine can cause

Guillain-Barré syndrome) – would motivate me to act in the same manner, and propose to Respondent that either the

case be settled or that it be resolved on the papers.

48

at best “secondary,” and nothing in Dr. Boles’s report undermines that conclusion. Indeed, as Dr.

McCandless has pointed out, Dr. Boles himself seems to agree (in many places in his report) that

C.J.K. did not suffer from a classic form of direct mitochondrial disease (and his confused and

contradictory treatment of the terms “disorder” versus “disease” do not aid him on this issue).

Boles Rep. at 1, 5, 9.

Similarly, I have found that the record better supports the conclusion, consistent with Dr.

McCandless’s reliable and persuasive opinion, that C.J.K. had no secondary mitochondrial disease

at all. This conclusion stems from a weighing of the evidence (as supporting one diagnosis over

the other) that I am empowered to make. I did not need to hear from an expert live to arrive at this

determinat

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