Dean v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 13-808V

(To be published)

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

* Special Master Corcoran

JESSICA DEAN and RYAN DEAN, on *

behalf of their minor child, I.D., *

* Filed: June 9, 2017

Petitioners, *

*

v. * Decision without Hearing;

* Dismissal; Diphtheria-Tetanus-

SECRETARY OF HEALTH AND * acellular Pertussis (“DTaP”)

HUMAN SERVICES, * Vaccine; Haemophilus Influenzae

* Type b (“Hib”) Vaccine;

Respondent. * Neurological Deficits.

*

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

Andrew D. Downing, Van Cott & Talamante PLLC, Phoenix, AZ, for Petitioners.

Darryl R. Wishard, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION DENYING ENTITLEMENT1

On October 17, 2013, Jessica and Ryan Dean, as parents of I.D., a minor, filed a petition

for compensation under the National Vaccine Injury Compensation Program (the “Vaccine

Program”).2 In it, the Deans alleged that I.D. developed “significant neurological deficits” as a

result of receiving the Diphtheria-Tetanus-acellular Pertussis (“DTaP”) and Haemophilus

Influenzae Type b (“Hib”) vaccines on February 24, 2011.

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 ruling 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 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 whole decision will be available to the public 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.

Although the matter was originally set for an entitlement hearing on March 14-15, 2017,

the parties subsequently expressed a willingness to have the claim decided on the record, and

therefore requested that it be taken off the trial calendar. The Deans have now filed a motion for a

Ruling on the Record, dated December 12, 2016 (ECF No. 64) (“Mot.”). Respondent reacted to

the Motion and asked for dismissal of the claim on January 11, 2017 (ECF No. 65) (“Response”),

and Petitioners then filed a reply in further support of their Motion on January 19, 2017 (ECF No.

66) (“Reply”). Having completed my review of the evidentiary record and the parties’ filings, I

hereby DENY Petitioners’ Motion for the reasons stated below and DISMISS their claim.

I. Factual History

Vaccination and Subsequent Medical History

I.D. was born on September 24, 2010, at full term via vaginal delivery with APGAR scores

of 8/9. Ex. 2 at 81; Ex. 3 at 6. Her hearing and newborn screens were normal, and she was

discharged after two days. Ex. 2 at 80-81. In the first several months of her life, I.D. was deemed

to be developing normally overall, although a few problems – specifically, some initial growth and

feeding issues, as well as an underlying heart murmur – were observed and addressed. Ex. 2 at 27,

29, 33, 35, and 74; Ex. 7 at 4.

On February 24, 2011, I.D. had a five-month visit with her pediatrician, Dr. Cornelia Franz,

who noted I.D.’s continued normal growth and development. Ex. 2 at 24. At this time, I.D. received

the vaccines at issue in this case: second doses of the DTaP and Hib vaccines. Id. She had received

the first dose of these on December 21, 2010, without any reported reaction. Ex. 2 at 8, 10.

A little over three weeks passed before I.D. returned to Dr. Franz on March 17, 2011, for

a sick visit to examine a rash. Ex. 2 at 23. At this time, I.D. was diagnosed with eczema, and though

the treatment plan recorded in Dr. Franz’s notes reflects an intent to wait on any further vaccines,

the contemporaneous records make no express mention of any adverse reaction to the February

24, 2011, vaccines. Id. Mrs. Dean, however, has alleged that I.D. experienced an immediately-

noticeable reaction after receiving the February 24th vaccines, characterized by screaming and

then a fever, plus projectile vomiting. Ex. 1 (Dean Affidavit) at ¶ 5; Ex. 10 (Declaration of Dr.

Franz (“Franz Decl.”)) at ¶ 3. Mrs. Dean has also maintained that I.D. was thereafter

uncharacteristically lethargic. Dean Affidavit at ¶ 6. Petitioners explained that two weeks later,

I.D. began to make what they now recall as abnormal movements, but because she was their first

child, they assumed it was normal infant activity (and therefore chose not to report their concerns

to Dr. Franz at that time). Dean Affidavit at ¶ 7; Franz Decl. at ¶ 4.

2

Records from treatment I.D. received in April 2011 provide the first contemporaneous

recording of concerns about I.D.’s development. Thus, the Deans took I.D. for another sick visit

with Dr. Franz on April 12, 2011, at which time Mrs. Dean’s observations of hand flapping were

noted. Ex. 2 at 22. Dr. Franz recorded I.D.’s behavior at the appointment as “normal hand

movement,” however, and explained that I.D. moving her fingers when excited was normal. Id.

The medical records also revealed that most of the appointment was spent reassuring Mrs. Dean

that I.D. exhibited normal infant behavior. Id. Thereafter, at the six-month well-child visit with

Dr. Franz on April 26, 2011, Mrs. Dean more directly expressed her concerns about I.D.’s

abnormal hand movements, noting that the symptoms had started two months before (or in late

February). Id. at 21. I.D.’s development and exam were normal, but she was referred to pediatric

neurology for further evaluation of her movements. Id. at 21; 66. Dr. Franz stated that if the

neurology examination was normal, I.D. should receive additional vaccinations at that time. Id. at

21.

On May 2, 2011, I.D. saw Dr. Ronald Davis, a pediatric neurologist, for evaluation of her

“unusual movements.” Ex. 2 at 66. Mrs. Dean showed Dr. Davis a video that displayed I.D. lifting

her hands to and from her face and twisting her hands in a flailing-like maneuver. Id. Dr. Davis

hypothesized that these episodes occurred whenever I.D. experienced a mood change, as he

witnessed one of these episodes during the appointment. Id. However, Dr. Davis also observed

that I.D. had no reports of experiencing any changes in her mental status, there was no sleepiness

associated with these spells, and she otherwise appeared to have been developing normally (based

on her records and examination). Id. Dr. Davis described I.D. as well-developed and healthy-

appearing, and he found her to be neurologically normal. Id. at 67. On that same day, I.D. also

underwent an EEG, which was completely normal. Id. at 68-69.

Given the above, Dr. Davis diagnosed I.D. with benign stereotypies of childhood, which

he described as a nonthreatening condition similar to a childhood tic disorder, and he cleared her

to receive further immunizations. Ex. 2 at 67. The Deans, however, remained concerned about the

purported observed changes in I.D.’s physical movements, and they have maintained in fact

statements filed after the initiation of this lawsuit that she had ceased verbalizing at six months of

age (although the medical records do not reference this alleged developmental problem even at the

time of Dr. Davis’s examination, which occurred when I.D. was about eight months old). Dean

Affidavit at ¶ 9; Franz Decl. at ¶ 5.

On June 29, 2011, I.D. had her nine-month well-child visit with Dr. Franz, who now noted

(in addition to what she characterized as otherwise normal growth and development) that I.D.

exhibited abnormal movements, reported as “tenses arms and legs when overstimulated . . .

twitching.” Ex. 2 at 19. Dr. Franz made the determination that further vaccination should be

withheld, although she did not explain why. Id. However, she noted that this decision to pause

3

vaccinations should be revisited before I.D. was 12 months old, depending on resolution of her

symptoms. Id.

This 12-month well-child visit occurred on September 26, 2011. Ex. 2 at 18. The medical

history from that visit stated that I.D.’s “abnormal movements” had been observed five months

after vaccinations (likely referring to the February vaccinations), and that I.D. still displayed some

involuntary physical movements (which Dr. Franz observed during the visit), although the hand

movements had largely resolved. Id. Otherwise I.D. displayed normal growth and development,

and no other concerns about her health were noted. Dr. Franz repeated the earlier diagnosis of

benign stereotypies of childhood to explain I.D.’s observed behaviors, and vaccines were deferred

again until the 15-month visit if her abnormal movements had stopped. Id.

Dr. Franz also saw I.D. on October 20, 2011, after Petitioners brought her in for evaluation

of pulling on her right ear and irritability after drinking milk. Ex. 2 at 17. Dr. Franz determined

that I.D. had a possible milk sensitivity and recommended avoiding cow’s milk. Id. I.D. was also

seen for a fever and a urinary tract infection (“UTI”) on October 28, 2011, and she was diagnosed

with a likely early viral illness. Id. at 16. She was seen again on November 4, 2011, to re-check

her urine levels following her UTI diagnosis. Id. at 15. Petitioners reported that I.D. had not had a

fever or vomiting since the last visit, and she was generally improving. Id. The plan was to continue

treatment for the UTI and practice good cleaning habits to prevent further infection. Id.

I.D. returned for her 15-month visit on December 28, 2011. Ex. 2 at 14. At this time, I.D.

was noted to be sensitive to sounds and textures, and some abnormal movements were again

reported and recorded. Id. I.D.’s growth, development, and physical exam were normal, however,

as before. Dr. Franz raised the possibility of a sensory integration disorder, and I.D.’s vaccines

were deferred yet another time. Id. at 14. The next relevant medical record is from I.D.’s March

28, 2012, 18-month exam. Id. at 13. The history from that visit noted that I.D. was now seeing an

occupational therapist, but that her speech was improving. Id.

Treatment of I.D.’s Motor and Developmental Problems

I.D. received speech and occupational therapy in 2012 and 2013 for feeding issues and

speech delay. Ex. 2 at 64; Ex. 4 at 74. Treatment records from this period identify her as a picky

eater who could say 10 to 15 words. See, e.g., Ex. 4 at 74. She was noted to have jaw and tongue

weakness, and she had been recommended for speech therapy to address her expressive language

delay. Id. Problems with sensory integration issues were also reaffirmed, and I.D.’s treaters

proposed therapies targeted at making her comfortable with certain sounds and textures without

significant aversion. Id.

4

Despite such treatments, I.D. was reported as displaying generally normal behavior during

this time. Id. Her final occupational therapy visit was on August 5, 2013, at which time no reports

of hand-flapping or other abnormal movements were reported (although they had been observed

in 2012 and earlier in 2013). Id. at 2. I.D. continued to receive speech therapy into 2014. Ex. 9 at

4 (I.D. “was discharged from occupational therapy just recently according to mom”).

Subsequent History and Reports of Post-Vaccination Adverse Event

The filed medical records reveal that beginning in 2013, Petitioners increasingly began

reporting to treaters that I.D. had experienced a severe and noticeable reaction to her February

2011 vaccinations – even though the contemporaneous medical history does not support that

recitation of events – and accordingly made requests for treatment adjustments. Thus, in

connection with an occupational therapy treatment visit in January 2013, Mrs. Dean reported that

I.D. had experienced an “initial reaction” to the February 2011 vaccines that moved into her arms

and legs before seemingly resolving a year later. Ex. 4 at 72.

Then, on May 17, 2013, Dr. Franz proposed in writing that I.D. receive a permanent

medical exemption from immunizations due to her purported adverse reaction. Ex. 2 at 10. On

June 7, 2013, Mrs. Dean completed a VAERS3 form, stating that I.D. had experienced an adverse

event on February 24, 2011 (the day of vaccination), including hand flapping, arm tensing, fever,

vomiting, and bruising; that her symptoms lasted over a year; and that she now suffered from a

permanent disability. Ex. 8 at 1-3.

Petitioners thereafter continued to report the same factual history to subsequent treaters –

which the treaters in turn relied upon. For example, on March 11, 2014, I.D. had another speech

therapy visit, at which time Petitioners stated that I.D. had experienced a reaction to her five-month

vaccines. Ex. 9 at 9. In June 2014, and after this case was filed, Dr. Franz signed a declaration in

support of Petitioners’ claim. See generally Franz Decl. Terming Petitioners “credible historians,”

Dr. Franz repeated their prior assertions (without reference to independent medical evidence) that

I.D. had experienced a fever and screamed and cried inconsolably on the day of her vaccinations.

Id. at ¶ 3. Based on this history (and again without offering independent corroborative evidence),

Dr. Franz concluded that I.D. had suffered an encephalopathic event due to her vaccinations and

that it was therefore proper to diagnose her with a “neuroencephalopathic reaction.” Id. at ¶ 6.

3

VAERS stands for the Vaccine Adverse Event Reporting System, which allows doctors and patients to self-report

any potential reactions to vaccines into a database. Centers for Disease Control and Prevention, Vaccine Adverse Event

Reporting System (VAERS), Vaccine Safety (last updated Aug. 28, 2015).

5

II. Expert Reports

A. Dr. David Axelrod

Petitioners’ immunology expert, Dr. David Axelrod, has offered a medical theory

attempting to causally connect I.D.’s February 2011 vaccinations and subsequent injury. See

Report, dated October 15, 2014, ECF No. 30-1 (Ex. 12) (“Axelrod Rep.”). Dr. Axelrod’s theory

largely proposes that I.D.’s vaccinations caused her developmental problems in two ways: first,

through the general propensity of any vaccination (as a result of its stimulating impact on the innate

immune system) to cause the upregulation of cytokines, which permits breaching of the blood-

brain barrier and also affects the central nervous system; and second, due to the specific pathologic

effects of the tetanus toxoid component of the DTaP vaccine on the brain.

Dr. Axelrod graduated from the University of Michigan Medical School in 1974 (after

obtaining his bachelor’s degree at Michigan as well). ECF No. 30-2 (Ex. 13) (“Axelrod CV”) at 1.

He completed two residencies in internal medicine, one at the University of Toronto and one at

William Beaumont Hospital, followed by additional residencies with a fellowship in allergy,

immunology, and rheumatology at McGill University. Axelrod CV at 1. He then served as a fellow

for the National Institutes of Health in the Clinical Immunology Laboratory. Id. Dr. Axelrod is

board certified in medicine, allergy and immunology, adult rheumatology, and medical laboratory

immunology. Id. He currently works in private practice, with the vast majority of his patients

having allergies, immunologic conditions, or autoimmune rheumatic diseases. Id. He does not

appear, however, to conduct research in immunologic matters relevant to the theory expressed in

this case.

Dr. Axelrod’s theory comprises several separate but temporally-dependent elements. First,

he opined that the vaccines at issue could cause the production of certain proinflammatory

cytokines4 immediately upon administration. Axelrod Rep. at 2. As shown by Kashiwagi et al.,

Production of Inflammatory Cytokines in Response to Diphtheria-pertussis-tetanus (DPT),

Haemophilus Influenzae Type B (Hib), and 7-valent Pneumococcal (PCV7) Vaccines, 10 Human

Vaccines & Immunotherapeutics 3:677-85 (2014) (Ex. 14) (“Kashiwagi”), vaccination results in

elevated levels of four kinds of cytokines. Id. at 1; Kashiwagi at 678. Kashiwagi was an in vitro

study comparing the levels of inflammatory cytokines in the sera of 61 vaccine recipients with

febrile illness, against 18 recipients without febrile illness, 24 hours after vaccination (a fairly short

period of time). Id. at 677. The study’s authors began with peripheral blood mononuclear cell

cultures and then introduced different combinations (separately or concurrently) of the DTaP, Hib,

4

A cytokine is a generic term for non-antibody proteins released by one cell population on contact with specific

antigen, which act as intercellular mediators, as in the generation of an immune response. Dorland’s Medical

Dictionary 466 (32nd ed. 2012) (hereinafter Dorland’s). The term “proinflammatory” signifies that these cytokines

are capable of stimulating inflammation. Id. at 1523.

6

and/or PCV7 vaccines in order to determine the levels of cytokine production in the cell cultures.

Id.

Based on Kashiwagi, Dr. Axelrod maintained that the relevant proinflammatory cytokines

involved in his theory are produced beginning six hours after vaccination and continue to increase

until 24 hours following vaccination. Axelrod Rep. at 1. He also maintained that these elevated

levels were found to persist after the 24 hour period. Id. Yet there are reasons to distinguish

Kashiwagi from the present matter and to find that its conclusions are less compelling than Dr.

Axelrod proposes. The results showing increased cytokine production were mainly seen with the

combinations involving the PCV7 vaccine, which is not present in this case. Kashiwagi at 679.

More significantly, Kashiwagi found no real difference between the two compared serum groups,

beyond the fact that one particular cytokine was elevated in individuals experiencing a febrile

illness. Id. at 680. Because Kashiwagi’s authors admitted that “[v]accine-specific innate

inflammatory responses . . . have not been sufficiently investigated regarding cytokine production

using difference vaccines,” they could not characterize this difference as significant (id. at 678),

and ultimately concluded that more analysis was required. Id. at 683.

Dr. Axelrod also relied on T.J. Lawley et al., A Prospective Clinical and Immunologic

Analysis of Patients with Serum Sickness, 311 New England J. of Med. 1407-13 (1984) (Ex. 18)

(“Lawley”), to support the idea that autoimmune cutaneous and rheumatologic manifestations

could occur anywhere from 10 to 25 days after exposure to an antigen. Axelrod Rep. at 2; Lawley

at 1410. Dr. Axelrod thus contends that Lawley supports his proposition that I.D. experienced

damage to her central nervous system immediately after her DTaP vaccination, followed by other

autoimmune manifestations of that damage 15 days after, and therefore her onset would be within

the 10 to 25 day timeframe that is posited as temporally appropriate.

Next, Dr. Axelrod proposed that certain of these cytokines (in particular TNF-α and

Interleukin-6 (“IL-6”) cytokines) purportedly increased by vaccine administration could

subsequently disrupt the blood-brain barrier and cause it to become more permeable. Axelrod Rep.

at 1; K. Rochfort et al., Downregulation of Blood-Brain Barrier Phenotype by Proinflammatory

Cytokines Involves NADPH Oxidase-Dependent ROS Generation, 9 PLoS ONE 7:1-13 (2014) (Ex.

15) (“Rochfort”). He relies on Rochfort for support of this idea, which involved a study of primary-

derived human brain microvascular endothelial cells (HBMvECs), and examined the effects of

proinflammatory cytokines on the expression of interendothelial junction proteins, as well as the

cytokines’ effects on HBMvEC monolayer permeability. Rochfort at 2. Rochfort sought to confirm

that either TNF-α or IL-6 cytokines could downregulate the expression of interendothelial

adherens and tight junction proteins and elevate paracellular permeability, thus lending credence

to the idea that these cytokines could possibly encourage blood-brain barrier dysfunction in

7

neurological diseases. Rochfort at 10-12.5 However, it is important to note that Rochfort focused

on IL-6 and TNF-α cytokines – different from the cytokine found to be significant in Kashiwagi

(G-CSF). See Rochfort at 1; Kashiwagi at 1. Additionally, Rochfort required the continuous

addition of cytokines via time and dose increases in order to obtain its specific results. Rochfort at

7. There is no suggestion in Rochfort that a vaccine reaction would be comparable, or that the

experiment was intended to replicate a vaccine reaction – indeed, the article does not mention

vaccines at all.

After cytokine production has been increased by vaccination and the blood-brain barrier

has been rendered more permeable, Dr. Axelrod proposed that “blood borne chemicals, such as

cytokines, as well as adaptive immune antibodies and cells, produced in the peripheral circulation,”

can now enter the central nervous system (“CNS”) and act upon it. Axelrod Rep. at 1-2. There are

two kinds of mediators that Dr. Axelrod specifically opined would harm the CNS and brain

sufficient to cause a developmental problem. First, the same cytokine upregulation causing the

blood-brain barrier’s breach can in turn stimulate microglia,6 which then produce additional

harmful cytokines that affect the CNS cells. Id. at 2 (citing Rochfort at 7). Dr. Axelrod also

referenced S.V. More et al., Cellular and Molecular Mediators of Neuroinflammation in the

Pathogenesis of Parkinson’s Disease, Mediators Inflamm. 952375 (2013) (Ex. 15) (“More”), for

the proposition that the presence and production of proinflammatory cytokines in the brain can

propagate and intensify neuroinflammation. More at 4.

Besides harm caused by cytokine upregulation attributable to vaccination generally, Dr.

Axelrod’s theory identified a vaccine-specific component as having the potential to cause injury.

Dr. Axelrod posited that the tetanus toxoid component of the DTaP vaccine can pass through the

now-breached blood-brain barrier. He alleged that the tetanus toxoid protein antigens introduced

by the DTaP vaccine could then bind to certain gangliosides found on neuronal brain tissue.

5

The report filed by Petitioners’ second witness, Dr. Harvey Cantor, proposes that the blood-brain barrier’s

permeability can be affected by the Bordetella Pertussis virus. See Cantor Report, dated May 26, 2015, ECF No. 39-

1 (Ex. 24), at 2 (“[i]mmune-mediated increased permeability of blood vessel walls following B. Pertussis was

described by Holt, et al., in 1961, and was suggested as an etiogenic pathway in encephalopathy following pertussis

immunization in 1976 by S. A Amiel” (citing L. Holt et al., Immunity in Mice to an Intracerebral Challenge of

Bordetella Pertussis, 59 J. Hyg. 373 (1961); S. Amiel, The Effects of Bordetella Pertussis Vaccine on Cerebral

Vascular Permeability, 57 Br. J. Path. 653 (1976)).

The significance of such literature, however, is fairly limited in this case, since the acellular form of the Pertussis

vaccine at issue herein is not comparable in effect to the whole-cell DPT version. See, e.g., James v. Sec’y of Health

& Human Servs., No. 09-284V, 2010 WL 4205699, at *11 (Fed. Cl. Spec. Mstr. Sept. 30, 2010) (both sides’ experts

agreed that the acellular form is less toxic than the whole-cell form, and subsequently adverse effects occur less often

with the acellular form than with administration of the whole-cell form, although the acellular form still contains some

toxicity); Sucher v. Sec’y of Health & Human Servs., No. 07-58V, 2010 WL 1370627, at *36 (Fed. Cl. Spec. Mstr.

Mar. 15, 2010) (discussing the differences between the whole-cell and acellular pertussis vaccines, specifically the

use of a toxoid in the acellular version).

6

Microglia are the small, non-neural, interstitial cells of mesodermal origin that form part of the supporting structure

of the central nervous system. Dorland’s at 1159.

8

Axelrod Rep. at 2; H.A. Louch et al., Identification of a Binding Site for Ganglioside on the

Receptor Binding Domain of Tetanus Toxin, 41 Biochemistry 13644:13644-52 (2002) (Ex. 19);

R.L. Schnaar et al., Brain Gangliosides in Axon-Myelin Stability and Axon Regeneration, 584

FEBS Lett 1741:1741-47 (2010) (Ex. 20). However, Louch only discusses the ability of the tetanus

toxin to bind to gangliosides and neuronal cells – not the toxoid form contained in the DTaP

vaccine. Louch at 13650-51. Dr. Axelrod nevertheless argued that the antibody and cellular

response to the tetanus toxoid binding to neuronal gangliosides in the brain could cause damage to

the surrounding tissues and allow for the development of a damaging immune response to other

structures of the neurons. Axelrod Rep. at 2. This would theoretically occur through the mechanism

of epitope spreading, which Dr. Axelrod described as the continuing and perpetuating ongoing

destruction of the neuronal tissue. Axelrod Rep. at 3 (citing B. McRae et al., Functional Evidence

for Epitope Spreading in the Relapsing Pathology of Experimental Autoimmune

Encephalomyelitis, 182 J. Exp. Med. 75:75-85 (1995) (Ex. 22) (“McRae”), and A. Vojdani, A

Potential Link between Environmental Triggers and Autoimmunity, 2014 Autoimmune Diseases

(2014) (Ex. 23) (“Vojdani”)).

Significantly, however, although Dr. Axelrod offered multiple literature items in support

of his theory, none involves the propensity of any vaccine to cause the kind of developmental

injury at issue in this case via the proposed process – or even the specific kind of injury at issue,

regardless of whether it was vaccine-caused. For example, Dr. Axelrod cited McRae and Vojdani

to support his description of epitope spreading. However, McRae is an animal study that focuses

on T-cell reactivity and autoimmune diseases such as multiple sclerosis, while Vojdani examines

autoimmune disorders generally and the environmental triggers which might cause individuals to

develop modified proteins that in turn trigger antibody production and the inflammatory process

that leads to autoimmune disorders. McRae at 83; Vojdani at 14. Thus, while these articles do

discuss and generally support Dr. Axelrod’s characterization of epitope spreading, they are largely

unrelated to the injury claimed in this case and Dr. Axelrod’s theory connecting I.D.’s specific

vaccinations to said injury.

B. Dr. Harvey Cantor

In addition to Dr. Axelrod’s opinion, the Deans have offered a three-page report from a

pediatric neurologist, Dr. Harvey Cantor. See Report, dated May 26, 2015, ECF No. 39-1 (Ex. 24)

(“Cantor Rep.”). Dr. Cantor obtained his M.D. from the Washington University School of

Medicine in 1962; he then completed a residency in pediatrics at the Stanford University School

of Medicine from 1965-1966 and a fellowship in pediatric neurology from 1966-1969. ECF No.

39-2 (Ex. 25) (“Cantor CV”) at 1-2. Dr. Cantor currently serves as a clinical professor in the

Department of Physician Assistant Education at the St. Louis University School of Allied Health

Professions, as well as a clinical professor of child neurology in the Department of Neurology at

the St. Louis University School of Medicine. Cantor CV at 1-2. He is board certified in pediatrics,

9

psychiatry, and neurology with a special competence in child neurology. Id. at 2. He also maintains

a private practice specializing in pediatric neurology in St. Louis, Missouri. Id.

Most of Dr. Cantor’s report reiterated facts about I.D.’s treatment contained in the medical

history. Cantor Rep. at 1-2. He largely accepted Dr. Franz’s conclusions without additional

elaboration – whether by citation to record points not already addressed or other evidence – as to

why those conclusions are correct.

Although Dr. Cantor’s specialty is neurology, the most substantive aspects of his report

mirror Dr. Axelrod’s assertions about the pathogenic capabilities of the DTaP vaccine. Thus, he

offered some literature that he argued demonstrates the “relationship between pertussis

immunization and severe/fatal medical complications,” as well as neurological complications

following pertussis immunization. Cantor Rep. 2. He proposed that one such article from the

1940s, Byers et al., Encephalopathies Following Prophylactic Pertussis Vaccine, 1 Pediatrics 437

(1948) (Ex. 26), demonstrates the possible neurologic damage that can result from pertussis

vaccination. He also cited another article involving Acute Necrotizing Encephalopathy (“ANE”),

which he maintained sheds light on the connection between DTaP and encephalopathy (although

nowhere in his report did Dr. Cantor specifically opine that I.D. ever experienced a vaccine-

induced encephalopathy, let alone ANE). Id. at 2 (citing X. Wu et al., Acute Necrotizing

Encephalopathy: An Underrecognized Clinicoradiologic Disorder, 2015 Mediators of

Inflammation (2015) (Ex. 30) (“Wu”)). Dr. Cantor relied on the Wu article to allege both that

vaccine-induced “[h]ypercytokinemia engenders proteolytic destruction of the blood-brain barrier

(BBB) . . . which subsequently increases vascular permeability and causes brain edema, petechial

hemorrhage, and necrosis,” and also that ANE could occur secondary to even the DTaP vaccine

(although according to the article, it would more likely be associated with the whole-cell Pertussis

form). Wu at 2.

C. Dr. Cornelia Franz

As noted above, Dr. Cornelia Franz has provided a declaration in support of Petitioners’

case. See generally Franz Decl. Dr. Franz’s curriculum vitae was not filed, but her declaration

reveals that she is a pediatric doctor at her own practice, The Franz Center, in Florida. Franz Decl.

at 1. She received her M.D. from Bowman Gray School of Medicine in North Carolina, and she

completed a pediatric internship in Kentucky followed by a pediatric residency at Shands Hospital

at the University of Florida. Id. She also completed a fellowship in adolescent medicine at

Cincinnati Children’s Hospital. Id. The recitation of her experience does not mention any specific

background in neurological issues specifically.

Dr. Franz’s declaration largely tracked the medical records, but also included her explicit

embrace of Petitioners’ witness statements (wholly undocumented in the record) about I.D.’s

10

reaction to the February 2011 vaccines, deeming them credible. Franz Decl. at 1-2. Relying on

such statements as well as her own treatment of I.D., Dr. Franz reached the conclusion that I.D.

developed short-term brain inflammation following her vaccinations, which resulted in residual

feeding difficulty and sensory issues. Id. at 2. She further noted that she later diagnosed I.D. with

a neuroencephalopathic reaction to her four-month vaccinations (although the record shows this

diagnosis did not occur contemporaneously with the receipt of these same vaccines), and placed a

permanent medical exemption from additional vaccinations on I.D.’s chart. Id.

D. Dr. Lawrence Brown

Dr. Lawrence Brown is Respondent’s sole expert, and he offered short written reports in

response to the reports of Drs. Axelrod and Cantor. See Report, dated February 5, 2015, ECF No.

37-1 (Ex. A) (“First Brown Rep.”) and Report, dated August 24, 2015, ECF No. 47-1 (Ex. E)

(“Second Brown Rep.”).

Dr. Brown is a pediatric neurologist at the Children’s Hospital of Philadelphia. ECF No.

37-2 (Ex. B) (“Brown CV”). He received his M.D. in 1971 from the New York University School

of Medicine, followed by a pediatric internship and pediatric residency at the Children’s Hospital

of Philadelphia in 1972 and 1973. Brown CV at 1. He also completed a fellowship in pediatric

neurology at the Children’s Hospital of Philadelphia from 1973-74 and 1976-78. Id. Dr. Brown

also currently serves as an associate professor of neurology and pediatrics at the University of

Pennsylvania School of Medicine, as well as the co-director of the Pediatric Regional Epilepsy

Program and Pediatric Neuropsychiatry Center at the Children’s Hospital of Philadelphia. Id. at 2.

He is board certified in pediatrics, psychiatry, and neurology with special competence in pediatric

neurology and sleep medicine. Id.

Dr. Brown’s first report responded solely to Dr. Axelrod’s opinion, while also offering a

counter-reading of the medical records based upon his expertise as a pediatric neurologist. Dr.

Brown largely accepted the view of Dr. Davis (himself a pediatric neurologist, as opposed to Dr.

Franz) that I.D.’s post-vaccination behaviors were benign stereotypies unconnected to the

February 2011 vaccines. First Brown Rep. at 3. Dr. Brown otherwise challenged Dr. Axelrod’s

opinion, noting that Dr. Axelrod provided nothing linking vaccination with motor stereotypies,

and stressing that I.D.’s alleged immediate reaction to the vaccines (as set forth in Mrs. Dean’s

witness statement) does not establish an encephalopathy or any other damage to the CNS. Id. at 2.

The second report that Dr. Brown offered reacted to Dr. Cantor’s opinion. Dr. Brown

acknowledged the “possibility (and rare actuality)” that immunization could cause neurologic

injury, but he disputed that this occurred to I.D. given the absence of persuasive proof in the

medical records that she actually experienced any reaction (such as an encephalopathy) to the

February 2011 vaccines. Second Brown Rep. at 1. He noted as well that Dr. Cantor’s offered

11

literature mostly relied on studies involving the whole-cell pertussis vaccine, rather than the

comparatively safer acellular version included in DTaP, and he went on to question the accuracy

of certain other factual assumptions in Dr. Cantor’s report. Id. at 2.7

III. Procedural History

As noted above, this action was initiated in October 2013. Petition at 1. After Petitioners

filed some of the medical records relevant to their claim, the parties spent a few months considering

settlement before Respondent determined in the spring of 2014 that amicable resolution of the case

was unlikely. Petitioners subsequently filed their first expert report from Dr. Axelrod in October

2014 – prompting Respondent to state officially that settlement was no longer possible. After

several months’ delay, Respondent finally completed and filed his Rule 4(c) Report on February

6, 2015, recommending against compensation, accompanied by Dr. Brown’s first expert report.

ECF Nos. 36 and 37.

The following months saw the filing of the parties’ two other reports – Dr. Cantor’s in

September 2015 (ECF No. 39), and a second report from Dr. Brown in August (ECF No. 47). The

parties also devoted time in 2015 to disputing an interim fees request that Petitioners submitted in

June, which I resolved by decision dated November 12, 2015 (ECF No. 53).

I thereafter requested that the parties propose a hearing date for resolution of Petitioners’

claim, entering a pretrial order in February 2016 that set the matter for trial in March 2017. ECF

No. 62. But in October 2016, the parties indicated during a status conference that they wished the

hearing to be cancelled and the matter resolved instead on the basis of the written filed submissions

and the existing medical record. I acceded to their request by Order dated October 20, 2016 (ECF

No. 63), and I issued a schedule for filing briefs in support of, or opposition to, Petitioners’ claim.

The parties made their written submissions, and the matter is now ripe for resolution.

7

Petitioners have challenged Dr. Brown’s competency to render an opinion in this matter, asserting that as a pediatric

neurologist, he lacks the expertise to render an opinion on immunologic topics. Mot. at 18. In so arguing, they compare

my treatment of Dr. Cantor’s qualifications in a different case that I decided, Wolf v. Sec’y of Health & Human

Services, No. 14-342V, 2016 WL 6518581, at *16 (Fed. Cl. Spec. Mstr. Sept. 15, 2016), where I found Dr. Cantor’s

opinion less persuasive for a similar reason. Mot. at 18 n.2.

Petitioners’ point is well-taken in a general sense. Far too often in the Vaccine Program, the parties ask medical

experts to opine on matters that exceed their primary expertise, or to recite the findings of medical or scientific

literature relevant to a petitioner’s case, without linking the testimony or statements to the expert’s own qualifications

or work. But in this case, the argument does not help Petitioners in proving their claim. For, as discussed below, my

findings as to the insufficiencies of Petitioners’ case principally arise from the unreliable or unpersuasive nature of

their own expert reports – without any consideration of Dr. Brown’s immunology arguments (although I do find that

his points about the record, and knowledge of pediatric neurology, are helpful in evaluating whether the record itself

reflects Petitioners’ theory in action under Althen prong two). If Wolf suggests that I should give Dr. Brown’s

pronouncements on immunologic matters less weight, then that applies with greater force to Petitioners’ expert, given

that Petitioners bear the ultimate burden of proof herein.

12

IV. Parties’ Respective Arguments

Petitioners maintain that they have established preponderant evidence in support of their

causation-in-fact claim for each of the three prongs set forth by the Federal Circuit in Althen v.

Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Mot. at 6-17. With respect

to their obligation to establish a reliable causation theory, Petitioners propose that Dr. Axelrod

(with assistance from Dr. Cantor) has done so by establishing that (a) the vaccines I.D. received

were likely to cause upregulation of proinflammatory cytokines, (b) such cytokines have been

shown to increase the permeability of the blood-brain barrier, (c) the same cytokines are

pathogenic to the CNS, and (d) the tetanus toxoid found in the DTaP vaccine is itself pathogenic

and binds to neurogangliosides in the brain, causing injury. Id. at 6-12.

For the second, “did cause” prong of the Althen test, Petitioners observe the fact that I.D.’s

developmental problems all post-date her February 2011 vaccinations, and that (at least according

to Mrs. Dean) she experienced an immediate reaction, which Dr. Cantor properly deemed

indicative of an adverse response affecting her CNS. Mot. at 12-13 (citing Cantor Rep. at 1). They

urge that Dr. Franz’s views (which rest on Petitioners’ uncorroborated statements about their

observations of I.D.) about the real-world impact of the vaccinations (and particularly her decision

to recommend a vaccine exemption for I.D.) merit weight since they come from a treater. Mot. at

14-15.

Finally, Petitioners argue that the timeframe in which I.D.’s vaccine reaction and

subsequent developmental problems occurred is medically appropriate. They note that Dr.

Axelrod’s citation to Kashiwagi supports the conclusion about the immediate impact of the

cytokine upregulation caused by vaccines. Mot. at 17 (citing Axelrod Rep. at 1). Otherwise, I.D.’s

symptomatology occurred in a timeframe consistent with Dr. Axelrod’s and Dr. Cantor’s medical

theories.

Respondent contests the adequacy of Petitioners’ showing. In his opposition, he maintains

that the medical record does not support Petitioners’ contention that I.D. suffered any immediate

neurologic injury post-vaccination related to her subsequently-manifesting developmental

problems. Response at 6-7. In support, he references medical record evidence affirmatively

establishing that I.D. was neurologically normal at that time. Id. at 8. He further maintains that

Petitioners’ causation theory is deficient, as it improperly leverages Kashiwagi and other items of

literature to conclude that vaccine-induced cytokine production can have a number of pathologic

impacts on an individual, when the existing science and medical literature largely does not support

that assumption. Id. at 11-12. And Respondent proposes that Petitioners’ experts lack sufficient

background and expertise on the immunologic or molecular biologic issues implicated in their

theory to opine reliably on these topics. Id. at 14-15.

13

Regarding the second and third Althen prongs, Respondent observes a lack of corroboration

between Mrs. Dean’s recollection of I.D.’s purported reaction to the vaccines and the record itself,

and the record evidence that does include those reactions merely reflects second-hand repetition

of things said to treaters rather than the treaters’ own independent observations. Response at 15-

16. The evidence, Respondent maintains, actually supports the conclusion that I.D.’s reaction was

transient and/or insufficiently severe to cause the developmental problems she later experienced.

Id. at 16-17. Respondent also questions the extent to which Petitioners’ theory provides a reliable

explanation for the timeframe from vaccination to onset of injury as set forth herein. Id. at 16.

Petitioners’ reply begins with an attempt to defend Dr. Axelrod’s credentials and expertise.

Reply at 1-4. It then argues in favor of the scientific bases for Petitioners’ theories, defending in

detail Kashiwagi, Rochfort, and the other items relied upon most heavily by Drs. Axelrod and

Cantor. Id. at 4-6. Petitioners go on to dispute the characterization of I.D.’s initial post-vaccine

neurologic state as normal and seek to rebut Respondent’s points about I.D.’s injury, such as

Respondent’s interpretation that I.D.’s EEG and examination by Dr. Davis were completely

normal. Id. at 6-7. Petitioners contend that these points are incorrect, specifically alleging that her

EEG did not mean that she was neurologically “normal,” and instead only showed that she was

not experiencing epileptiform activity during the testing. Id. Otherwise, Petitioners’ reply repeats

their earlier arguments that they have met their burden of proof to establish vaccine causation. Id.

at 9-11.

V. 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).8

In this case, Petitioner does not assert a Table claim.

8

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).

14

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance

of the evidence” burden of proof. Section 13(a)(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: “(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.” Althen, 418 F.3d at 1278.

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

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

15

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 Fed. 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

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

16

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. 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

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

17

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, contemporaneously 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

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 v. Sec’y of Health & Human Servs., 23

Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992)). 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.

18

C. 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

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 Fed. App’x 999 (Fed. Cir. 2013) (citing Cedillo,

617 F.3d at 1339).

19

D. Consideration of Medical Literature

Both parties relied on a few pieces of medical and scientific literature in this case to support

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).

E. Determination to Resolve Case without Hearing

The parties have jointly agreed that I should decide entitlement in this case based on the

written submissions and evidentiary filings, including each side’s expert reports. 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. See 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. 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; Murphy v. Sec’y of Health & Human Servs., No. 90-882V, 1991 WL 71500, at *2 (Ct. Cl.

Spec. Mstr. Apr. 19, 1991).

ANALYSIS

After careful review of the expert reports, medical records, and the competing arguments

of both sides, and in light of my own accumulated experience resolving similar claims (as well as

parallel decisions from other Vaccine Act cases), I conclude that Petitioners have not established

preponderant evidence in favor of their claim.

A. Petitioners Have Not Shown that I.D. Experienced an

Encephalopathy or Other Immediate Vaccine-caused Injury.

The record does not support Petitioners’ conclusion that, more likely than not, I.D.

experienced a post-vaccination encephalopathy or some other immediate reaction severe enough

to later manifest as a neurologic injury. There is no credible proof in the record that I.D. suffered

from an encephalopathy, seizures post-vaccination, a seizure disorder, or epilepsy or that her four-

20

month vaccinations caused any other medical problem. Rather, the records simply suggest that I.D.

received the vaccinations in question, and then, about six weeks later, Mrs. Dean first began to

inform treaters of the abnormal movements she saw I.D. displaying. At the same time, there is

evidence in the same record undercutting claims of an alarming or abnormal reaction. Thus, I.D.’s

EEG (a test which would more likely than not reveal neurological damage) on May 13, 2011, was

normal (Ex. 2 at 69) and treaters such as Dr. Davis proposed an alternative diagnosis more

consistent with the medical record.9

Petitioners propose to fill in the six-week gap in the records between vaccination and the

first reports of I.D.’s developmental problems with Mrs. Dean’s eyewitness accounts of I.D.’s

purported reaction. Thus, to find for Petitioners, I would have to accept Mrs. Dean’s recitations,

along with her explanation that she opted not to inform treaters, or that I.D.’s physicians simply

ignored her concerns and therefore did not write down what she told them. But Petitioners cannot

establish that an event occurred simply based upon their uncorroborated allegations – especially

where the contemporaneous proof rebuts those after-the-fact allegations. Section 13(a)(1);

Cucuras, 993 F.2d at 1528. Rather, controlling law gives greater weight to written records, based

on the reasonable proposition that an individual would more likely than not tell a treater of an

observed medical problem or concern – and that in turn the treater (in the effort to provide the best

care possible) would examine such concerns and take note of them.

To further bulwark allegations of I.D.’s reaction (as well as their contention that the

February vaccines caused her symptoms), Petitioners offered the statement of Dr. Franz. There is

no dispute that Dr. Franz was one of I.D.’s contemporaneous treaters, and it is well established in

the Vaccine Program that “medical records and medical opinion testimony” of treating physicians

can be “probative,” because “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.” Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1278). But statements from

treating physicians are not sacrosanct and can be rebutted and found by a special master to be

unreliable or not dispositive in light of the record as a whole. Section 13(b)(1); Snyder, 88 Fed. Cl.

at 746 n.67; Davis v. Sec’y of Health & Human Servs., No. 07-451V, 2010 WL 1444056, at *14

(Fed. Cl. Spec. Mstr. Mar. 16, 2010).

9

It is instructive to compare the facts of this case with those exceedingly rare cases in which a claimant has established

an encephalopathy following vaccination (although both are also distinguishable for another reason – as both involved

Table claims in which causation was assumed). In one such instance, the vaccinated child developed a very high fever

within 48 hours of vaccination, thereafter displaying crying, sleeplessness, and significant motor problems, all of

which were documented in the medical record. Poling v. Sec’y of Health & Human Servs., No. 02-1466V, 2011 WL

678559, at *1 (Fed. Cl. Spec. Mstr. Jan. 28, 2011). In another, the vaccinated child received a multi-virus vaccine and

experienced a seizure on the trip home from the vaccination, followed by a week of noticeably decreased levels of

consciousness and lethargy. Wright v. Sec’y of Health & Human Servs., No. 12-423V, 2015 WL 6665600 (Fed. Cl.

Spec. Mstr. Sept. 21, 2015). In Petitioners’ case, by contrast, there are no contemporaneous records establishing any

proximate temporal reaction to the vaccines that would support a finding that I.D. experienced such an encephalopathy.

21

This case provides a cogent example of the proper circumstances in which to give a treater

opinion less weight than urged by a petitioner. As Dr. Franz’s own declaration makes clear, many

of the facts upon which her opinion is based were derived from the Deans’s recitation of I.D.’s

medical history, rather than from her own independent examinations or observations. See Franz

Decl. at ¶ 3 (“[I.D.]’s parents are credible historians”). Indeed – Dr. Franz’s declaration does not

even say that she reviewed the medical record before offering an opinion. At the same time, the

actual contemporaneous record (which Dr. Franz helped create as a treater) offers little to no

support for her conclusions. When an expert relies on questionable or rebutted facts, that opinion

is properly accorded less weight. See Dobrydnev v. Sec’y of Health & Human Servs., 566 F. App’x

976, 983 (Fed. Cir. 2014) (expert’s opinion based on facts that were not supported by a

preponderance of the evidence were appropriately rejected by special master); Davis v. Sec’y of

Health & Human Servs., 20 Cl. Ct. 168, 173 (1990); Raley v. Sec’y of Health & Human Servs.,

No. 91-732V, 1998 WL 681467, at *7 (Fed. Cl. Spec. Mstr. Aug. 31, 1998) (“the conclusions of

an expert are only as sound as their factual predicate”). Accordingly, the conclusory diagnosis Dr.

Franz gives, after the fact rather than at the time of treatment, has little probative value, and it is

not redeemed by Dr. Franz’s treater status in this case.

At the same time, contrary treater evidence exists that is more reliable and persuasive. Dr.

Davis, I.D.’s treating neurologist (and thus more of a specialist in injuries relevant to the

Petitioners’ claim), evaluated I.D.’s medical condition and symptoms at the time (along with what

the Deans told him), but deemed I.D.’s neurological status normal after examining her on May 13,

2011. Ex. 2 at 66-69. He characterized I.D.’s condition as “benign stereotypies,” which he

described as comparable to a childhood tic disorder. Id. at 67. And consistent with his overall

diagnosis that her symptoms were not likely serious, I.D.’s “abnormal movements” resolved within

one year, as Mrs. Dean noted in her visit with an occupational therapist on January 21, 2013. Ex.

4 at 72. Dr. Davis’s diagnosis that I.D. suffered from idiopathic benign motor stereotypies that

may have later been connected to other sequelae (but were not evidence of vaccine-caused

neurologic injuries) is thus more consistent with the contemporaneous medical record than Dr.

Franz’s opinion.10

B. Petitioners Have Not Established a Reliable or Persuasive Causation Theory.

Petitioners’ theory – that the DTaP and Hib vaccines, separately or in concert, could

precipitate an encephalopathic event or other neurologic injury resulting in developmental

problems – is unreliable, both on its own merits and also due to the insufficiencies of the expert

reports offered in its support.

10

Petitioners argue in their Reply that Dr. Davis was not technically a “treating” physician because he only evaluated

I.D. on one visit. However, an expert’s opinion is not inherently deserving of less weight based on the length of time

that a treater saw and evaluated the patient. Rather, as with any medical record, context matters – and here, the records

from other treaters who may have seen I.D. more often do not persuasively rebut Dr. Davis’s findings.

22

The most immediately apparent weakness in this case’s causation theory is the heavy lifting

it assigns to the post-vaccination cytokine production process as the cause of almost all of the

pathologic effects of the vaccines at issue. Many of the general principles (as evidenced by

Petitioner’s expert reports plus the filed medical or scientific literature) that underlie this theory

are not disputed. As Respondent specifically acknowledges, vaccination inherently induces the

production of cytokines, and inflammation and fever are anticipated byproducts of a vaccine’s

administration. See Response at 11 n.11. In addition, it is understood that cytokines play a role in

brain function – and specifically in protecting the brain from infection and damage. Id. at 12 n.12.

And Petitioners have offered credible and reliable scientific literature, like Kashiwagi, that

measures the increased production of cytokines post-vaccination, or that discuss the role cytokines

may play in weakening the blood-brain barrier.

But science confirming or discussing the role that cytokines are known to play in the

immunization process is not enough by itself to establish Petitioners’ claim herein. Petitioners seek

to demonstrate not just that vaccines induce cytokine upregulation, but that vaccines can do so

pathologically, and for extended periods of time, sufficient both to cause a breach in the blood-

brain barrier and subsequent damage to the brain, later manifesting as a developmental injury.

Thus, in order to go beyond the general concepts that articles like Kashiwagi emphasize, the

Petitioners required additional credible and reliable scientific or medical evidence – but they have

not provided such proof.

Rather, Dr. Axelrod relies heavily on Kashiwagi, but it does not stand for the proposition

cited. Not only was Kashiwagi’s study not designed to examine the effects of cytokines in the brain

following vaccination, but its central purpose (comparing the levels of inflammatory cytokines in

the sera of vaccine recipients with febrile and non-febrile illnesses within 24 hours of vaccination)

does not shed light on whether the particular kinds of cytokines produced in the study could cause

the injury proposed herein (a CNS-oriented injury, as opposed to peripheral cytokine changes

occurring at the locus of vaccination).

Beyond the above, neither Kashiwagi nor any other literature that Petitioners cite

establishes that cytokine upregulation could be maintained biologically for long enough, and in

sufficient quantities as well, to act as Dr. Axelrod’s theory proposes. In fact, Kashiwagi’s study

shows that cytokine production increased only for approximately 24 hours following stimulation.

Kashiwagi at 3. Further, the only increased cytokine identified in the serum of the test subjects

was an elevated G-CSF level in individuals with a febrile illness, and the authors were unable to

determine the significance of this result. Id. The decisions of other special masters (albeit not in

precisely the same circumstances) have noted that Kashiwagi does not support the idea that

cytokines produced in response to vaccination could negatively impact the brain in the way Dr.

Axelrod proposes herein. See, e.g., Copenhaver v. Sec’y of Health & Human Servs., No. 13-1002V,

2016 WL 3456436, at *9-14 (Fed. Cl. Spec. Mstr. May 31, 2016) (infant’s death not caused by

23

cytokine upregulation due to vaccination), mot. for review den’d, 129 Fed. Cl. 176 (2016); Cozart

v. Sec’y of Health & Human Servs., No. 00-590V, 2015 WL 6746499, at *6-7 (Fed. Cl. Spec. Mstr.

Oct. 15, 2015), mot. for review den’d, 126 Fed. Cl. 488 (2016)

Petitioners rely in turn on Rochfort to show how cytokines could theoretically increase the

permeability of the blood-brain barrier. At the outset, however, it is worth noting that Rochfort

was an in vitro study, and thus may not necessarily be illuminating when proposed for an in vivo

process – a fact the study itself admits. See Rochfort at 7. Rochfort also notes that cytokines are

not even necessarily understood to be toxic to the brain. See id. (“several studies also report

evidence of a neuroprotective role for [TNF alpha] in the brain”). And in any event, Rochfort

suffers from some of the same limiting factors as Kashiwagi (i.e. not addressing vaccines). Thus,

even if Rochfort offers some support for Petitioners’ theory, it is not enough by itself to establish

preponderant evidence that vaccination would more likely than not allow permeation of the blood-

brain barrier simply due to cytokine upregulation expected to be caused by the vaccine in the first

place.

All in all, there is a sweeping quality to this element of Petitioners’ theory. All vaccinations

could potentially cause the pathologic cytokine upregulation Dr. Axelrod’s theory proposes, along

with the increase in the blood-brain barrier’s permeability and concurrent toxic interaction –

simply through the working of the body’s innate immune reaction to vaccination. If so, there

should be plenty of research supporting this theory and bulwarking Petitioners’ contentions – if

not with respect to all vaccines, then at least in connection with the ones at issue herein. But no

such evidence has been offered – and even though Petitioners need not offer literature to prove

their case, the absence of such additional proof greatly undermines the reliability of this part of

their theory.

The side of Petitioners’ theory addressing the allegedly pathologic nature of components

of the DTaP vaccine similarly lacks scientific reliability. Petitioners allege that whatever amount

of tetanus toxoid is found in the DTaP vaccine is enough to bind to site receptors in the brain, and

they offer case reports about adverse events associated with the pertussis vaccine in support of this

contention. See Exs. 19-22, 26, 29. But they bulwark these contentions with fairly outdated

literature, literature involving the whole-cell DPT form of the vaccine, or both. Petitioners simply

have not shown that the acellular form of pertussis toxoid contained in DTaP would necessarily

have the same effect as the whole-cell formulation – or that it would cause the specific injury in

this case. In fact, likely the opposite is true. See, e.g., Taylor v. Sec’y of Health & Human Servs.,

108 Fed. Cl. 807, 820 (2013) (noting that the modern DTaP vaccine has evolved from attempts to

minimize the amount of toxin in the vaccine as compared to past versions); James v. Sec’y of

Health & Human Servs., No. 09-284V, 2010 WL 4205699, at *11 (Fed. Cl. Spec. Mstr. Sept. 30,

2010) (stating that the acellular form of the pertussis vaccine is much less toxic than the whole-

cell form).

24

Respondent has also raised legitimate points about Dr. Axelrod’s competency to offer the

theory espoused in this case. Dr. Axelrod is certainly the only immunologist to render an opinion

in this case, and as such I have taken his report seriously and given it primary consideration on

such topics. But it is undeniable that despite his general competency to opine on immunology, he

lacks demonstrated specific experience in studying cytokine function, the particular vaccines at

issue, or their propensity to cause developmental injuries of the sort alleged herein.11 He cannot

represent that he has direct, relevant experience such that I should credit his opinions even in the

absence of scientific or medical literature supporting Petitioners’ theory. A theory does not obtain

additional reliability simply because it comes from an immunologist, when that immunologist has

no demonstrated expertise in the specific issues in question.12 See Snyder v. Sec’y of Health &

Human Servs., 553 Fed. Appx. 994, 1000-02 (Fed. Cir. 2014) (special master was not arbitrary

and capricious in rejecting testimony of expert who had read literature to support an opinion, but

had no individual experience treating patients with the relevant disease); Daubert, 43 F.3d at 1317

(“[o]ne very significant fact to consider is whether the experts are proposing to testify about

matters growing naturally and directly out of research they have conducted independent of the

litigation, or whether they have developed their opinions expressly for purposes of testifying”).

Here, I find that Dr. Axelrod’s opinion was less persuasive due to this lack of specific familiarity

and expertise on the vaccines and injuries directly at issue.

C. The Remaining Althen Prongs have not Been Satisfied.

Although I have only specifically discussed the deficiencies in Petitioners’ Althen prong

one showing, their claim fares no better under the other two prongs.

First, Petitioners have not established that their theory about the role of vaccine-induced

cytokines causing a neurologic injury is reflected in the medical history (the “did cause,” or second

Althen prong). As already noted, there is no record evidence that I.D. experienced a severe reaction

to her five-month vaccinations outside of Petitioners’ own after-the-fact claims – and those claims

are not corroborated by other evidence, such as lab results or testing. Meanwhile, there is

persuasive contrary evidence (Dr. Davis’s conclusions, the normal EEG results, etc.) suggesting

that I.D. was in fact not experiencing a damaging neurologic reaction. Petitioners can point to

nothing else that would demonstrate the cytokine upregulation they posit was occurring in the

period between February 24, 2011, and mid-April of that year (I.D.’s next visit with Dr. Franz), or

11

Dr. Axelrod’s ability to successfully opine about cytokines has been questioned before by other special masters.

See, e.g., Copenhaver, 2016 WL 3456436, at *9.

12

As previously noted, Petitioners are not incorrect in observing that Respondent’s expert, Dr. Brown, himself lacks

direct or extensive immunologic expertise – but that does not mean that Dr. Axelrod’s opinions must be accepted

simply because he is more credentialed in the topic. Indeed – since Petitioners bear the burden of proof, it is the

competency of their own experts that is most important.

25

that she experienced an encephalopathy, whether or not autoimmune in nature. At most (and

crediting Mrs. Dean’s testimony generally), the evidence would support the conclusion that I.D.

experienced a local, transient reaction to her vaccination that resolved without the need for serious

medical intervention.

Second, Petitioners have not demonstrated a medically acceptable timeframe to explain the

biological course of I.D.’s injury, from the February 24, 2011, vaccinations to manifestation of

developmental symptoms later that spring (at earliest). Accepting Petitioners’ uncorroborated

allegations, I.D.’s first symptoms began shortly after vaccine administration (evidenced by her

purported crying, fever, and vomiting) and then around two weeks later presented in the form of

her “abnormal” hand movements. This timeframe is somewhat consistent with Dr. Axelrod’s

proposed (albeit vaguely-outlined) time period for the cytokine upregulation, but his theory does

not fully explain the gap between the neurologic component of I.D.’s injury and her immediate

purported reactions to the vaccines. And even if it did, the medical records (which, as already

stated several times, contain no mention of an alleged reaction or symptoms at I.D.’s March 17th

pediatric visit) are not wholly consistent. I also note that Petitioners’ inability to corroborate their

allegations about the vaccine reaction and process of injury with medical record proof further

diminishes their argument that the injury occurred in a reasonable timeframe following the date of

vaccination. At bottom, Petitioners are relying on a mere temporal post-vaccination manifestation

of a developmental injury that, without some additional evidence to show events were unfolding

as would be predicted, is insufficient to meet their preponderant evidence burden.

Based upon my overall review of the medical records, along with competing treater

explanations for I.D.’s condition, I find it is not “more likely than not” that I.D.’s developmental

problems were related to her receipt of DTaP or Hib vaccines. Rather, the evidence more

persuasively suggests (in line with Dr. Davis’s diagnosis) that I.D. experienced idiopathic benign

motor stereotypies after vaccination, and sometime thereafter experienced some developmental

sensory challenges and minor expressive language delay that were unrelated to the vaccinations.

CONCLUSION

The record does not support the Deans’s contention that the vaccines I.D. received in

February 2011 could, or did, cause her subsequent developmental symptoms. Petitioners have not

established entitlement to a damages award, and therefore I must DISMISS their claim.

26

In the absence of a timely-filed motion for review (see Appendix B to the Rules of the

Court), the Clerk shall enter judgment in accordance with this decision.13

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Special Master

13

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their

right to seek review.

27