Kottenstette v. Secretary of Health and Human Services

In the United States Court of Federal Claims

No. 15-1016V

Filed Under Seal: July 27, 2020

Reissued: August 11, 2020 *

NOT FOR PUBLICATION

MARYELLEN KOTTENSTETTE and

NICHOLAS KOTTENSTETTE, as best

friends of their daughter (CK),

Petitioners, Keywords: Vaccine; Motion

for Review; Althen Test;

v. Infantile Spasms; DTaP

Vaccine; DPT Vaccine

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

John F. McHugh, Law Office of John McHugh, New York, New York, for the petitioners.

Camille Michelle Collett with Voris Edward Johnson, Torts Branch, Civil Division, U.S.

Department of Justice, Washington, D.C., for the defendant.

MEMORANDUM OPINION AND ORDER

HERTLING, Judge

For vaccine injuries not already recognized in the Department of Health and Human

Service’s Vaccine Injury Table, a petitioner must prove that the vaccine (1) “can” cause and (2)

“did” cause the injury. See Pafford v. Sec’y of Health & Human Servs., 451 F.3d at 1352, 1355-

56 (Fed. Cir. 2006). The petitioners’ daughter, C.K., suffers from severe psychomotor regression

attributed to a seizure disorder called “infantile spasms.” The petitioners observed C.K.’s first

seizure ten hours after C.K. had received the combined vaccine for diphtheria, tetanus and

pertussis (the “DTaP” vaccine) at her four-month wellness exam. The petitioners argue that the

*

Pursuant to Vaccine Rule 18(b), this opinion was initially filed under seal, and the parties

were afforded 14 days after the filing of this opinion within which to notify the court of any

information that should be redacted from this decision for reasons of privilege or confidentiality.

The parties did not propose any redactions. Accordingly, this opinion is reissued in its original

form for posting on the Court’s website.

DTaP vaccine “can” cause infantile spasms by lowering the threshold for a seizure to occur, and

that it “did” trigger the early onset of C.K.’s infantile spasms at an age when the seizures would

be most damaging to C.K.’s brain.

The most recent decision on the petitioners’ claim, issued by Special Master Horner

following remand by this Court, denied the petitioners compensation, finding insufficient

evidence that the DTaP vaccine caused the onset of C.K.’s infantile spasms. 1 Kottenstette v.

HHS, No. 15-1016 (Fed. Cl. Spec. Mstr. June 2, 2020) [hereinafter Decision on Remand],

https://ecf.cofc.uscourts.gov/cgi-bin/show_public_doc?2015vv1016-142-0. The petitioners

move for review of that decision. The Court denies the motion for review and sustains the

Special Master’s decision.

I. BACKGROUND

The Court reviews first the details of C.K.’s injury and then the history of this case.

A. DTaP Vaccination and Seizure Disorder

C.K. received the DTaP vaccine, along with other vaccines, at her four-month wellness

visit in October 2012. That same day, and again four days later, C.K.’s parents observed her

moving her arms, legs, and shoulders in a manner that a treating neurologist consulted by the

petitioners determined was consistent with the “infantile spasms” seizure disorder. The

neurologist treated C.K. with a standard treatment for the disorder, adrenocorticotropic hormone

(“ACTH”).

At a follow-up visit three weeks later, the petitioners reported some improvement while

C.K. was treated with ACTH, reporting that the seizures were more frequent (three to five per

day) but of shorter duration (one to two minutes). (ECF 9-1 at 10-11.) They reported no

regression in C.K.’s development since the onset of the seizures. (Id. at 11.) During another

follow-up visit, two weeks later, they noted less frequent and less severe seizures, along with

normal development.

Three-and-a-half months after C.K.’s vaccination and first observed seizure, C.K.

appeared to be suffering progressive brain damage with “less movements and arrested

development with some elements concerning for regression, particularly her head control and

level of interaction.” (ECF 9-2 at 4.) C.K.’s ACTH treatment lasted through early December.

Ms. Kottenstette later testified at the entitlement hearing that C.K. declined rapidly after the

ACTH treatment was stopped. (Id. at 10.) C.K. started and continued having approximately 30

seizures per day lasting between 10 and30 seconds. These seizures did not respond to

medication. (ECF 86-1 at 15.)

1

The Court vacated and remanded an earlier decision in this case reached by another special

master, holding that it had applied the wrong legal standard. See Kottenstette v. HHS, No. 15-

1016, 2020 WL 953484 (Fed. Cl. Feb. 12, 2020).

2

As of June 2017, C.K. had “physical disabilities that impact her functional mobility,

postural stability, eye-hand coordination, fine motor control, pre-writing skills, and self-care

skills” and “a visual impairment that affects her performance on visually-based activities.”

Decision on Remand at 4 (summarizing medical records). Further, C.K. “can differentiate

sounds and turn her head toward unfamiliar sounds, but she does not yet respond to her name.”

Id. C.K. “does not yet understand any words and does not yet use gestures to communicate.” Id.

B. Initial Decision Granting Compensation

The petitioners filed a petition for compensation in 2015. (ECF 1.) Special Master

Millman held a hearing on entitlement to compensation. At that hearing, petitioner Ms.

Kottenstette, the petitioners’ expert, and the respondent’s expert testified. (See Transcript, ECF

66 [hereinafter cited as “Tr.”] Special Master Millman granted compensation, finding that the

DTaP vaccine was a “substantial cause” of C.K.’s developmental disabilities because the vaccine

hastened the onset of the brain-damaging infantile spasms that C.K. otherwise might only have

experienced later in her development. Kottenstette v. HHS, No. 15-1016, 2017 WL 6601878

(Fed. Cl. Spec. Mstr. Dec. 12, 2017). Special Master Millman thereafter awarded damages on

the basis of her earlier finding of entitlement. Kottenstette v. HHS, 2019 WL 2587395 (Fed. Cl.

Spec. Mstr. May 29, 2019).

After these decisions, Special Master Millman retired and the case was reassigned to

Special Master Horner.

The respondent, the United States Department of Health and Human Services, moved for

review of Special Master Millman’s entitlement decision. (ECF 107.) This Court found the

legal standard and evidentiary basis of Special Master Millman’s decision unclear, vacated the

decision, and remanded the case for further consideration of causation under the three-prong test

established by Althen v. Secretary of HHS, 418 F.3d 1274 (Fed. Cir. 2005). 2 See Kottenstette v.

HHS, No. 15-1016, 2020 WL 953484 (Fed. Cl. Feb. 12, 2020).

This Court summarized the Althen test as follows:

2

Special Master Millman’s decision was ambiguous as to whether she had applied the Althen

causation standard or dispensed with Althen on account of a correlation between C.K.’s facts and

an immunological study together with the short, 10-hour delay between vaccination and the onset

of CK’s first seizure. Special Master Millman relied on Knudsen ex. rel. Knudsen v. Secretary of

the Department of HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994), and another special master’s

decision, see H.J. v. Sec’y of HHS, No. 11-301V, 2015 WL 6848357 (Fed. Cl. Spec. Mstr. Nov.

6, 2015), to conclude that “when a [vaccine recipient] would fit within an epidemiological study,

that alone is sufficient proof of vaccine causation.” Kottenstette, 2017 WL 6601878 at *13, *14.

Special Master Millman then concluded that “because CK would have qualified to have been in

the Bellman and Melchior studies [discussed below], the undersigned finds that her four-month

vaccinations triggered the onset of her cryptogenic seizures.” Id. at *14.

3

The Vaccine Act requires preponderant evidence of causation. 42

U.S.C. § 300aa-13(a)(1)(A). A petitioner must show the harm was

more likely than not caused by the vaccine. Althen’s three prongs,

together, enumerate the facts that are relevant and essential to prove

causation in cases such as this one, in which the possibility of injury

is not already recognized in the Vaccine Table. Althen requires “(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.”

418 F.3d at 1278.

Id. at *3.

C. Decision on Remand Denying Compensation

On remand, Special Master Horner reviewed the record, concluded that both parties had

had a full and fair opportunity to present their cases, found no new, unaddressed issues, and

issued a decision denying compensation. (ECF 131, withdrawn by ECF 134.) The petitioners

moved to reopen the record and for reconsideration. (ECF 133.) They argued that this Court’s

decision remanding the case had heightened their burden of proof after the record had been

closed. Special Master Horner withdrew his earlier decision in order to consider the petitioners’

arguments. (ECF 134.) Special Master Horner ultimately denied the motion to reopen the

record (ECF 141) and issued a superseding decision denying compensation. See Decision on

Remand at 4.

In the decision on remand, Special Master Horner applied the Althen test to the two

studies that Special Master Millman had found were dispositive in proving causation. Id. at 10-

13 (discussing M.H. Bellman, E.M. Ross & D.L. Miller, Infantile Spasms and Pertussis

Immunisation, 1 Lancet 1031 (1983) (ECF 54-1); J.C. Melchior, Infantile Spasms and Early

Immunization Against Whooping Cough, 52 Archives of Disease in Childhood 134 (1977) (ECF

54-2). Special Master Horner found that these studies were insufficient as evidence that the

DTaP vaccine could cause the onset of infantile spasms. Id. at 13. He then applied the Althen

test to the specifics of the petitioners’ theory of causation, which Special Master Millman’s

earlier decision had not addressed. See id. at 6, 14-20. Special Master Horner found that the

petitioners had failed to establish by a preponderance of the evidence that vaccination, as

opposed to infection, could start a seizure-triggering immune response. Id. at 20. Special Master

Horner accepted that a vaccine can contribute to a seizure-triggering fever or other inflammation

but nevertheless found insufficient evidence that C.K. had suffered from a fever or other

inflammation when her first seizure occurred. Id. at 21-25. In Special Master Horner’s view, the

petitioners narrowly satisfied Althen’s first prong but failed to satisfy Althen’s second prong

because they had failed to show that the facts of C.K.’s injury fit the only theory of causation that

they had established.

4

1. The Melchior and Bellman Studies

In the decision on remand, Special Master Horner first analyzed what weight, if any, he

should give to the Melchior and Bellman studies that Special Master Millman had found

dispositive. Decision on Remand at 10-13 (discussing Melchior and Bellman, supra). The

Melchior study examined whether giving children the then-dominant DPT formulation of the

pertussis vaccine at an earlier age would affect the typical onset-age of infantile spasms. Id. at

10-11.

Special Master Horner gave no weight to the Melchior study. Id. at 13. The study’s

author rejected a causal connection between the pertussis vaccine and infantile spasms and, more

significantly, the study’s statistical observations of the safety of the DPT vaccine could not be

reasonably applied to the DTaP vaccine, which had specifically been developed to be safer than

the DPT vaccine. Id. at 12. Special Master Horner noted that previous vaccine-compensation

decisions had persuasively concluded that the DPT vaccine’s safety statistics could not

reasonably be applied to the DTaP vaccine. 3 Id. at 11.

The petitioners’ expert on neurology, Dr. Marcel Kinsbourne, M.D., opined that DPT’s

safety findings were applicable to the DTaP vaccine, but with a lower incidence of infantile

spasms arising from the DTaP formulation. Id. at 12 (citing Tr. at 57, 92-93). The DTaP

vaccine, Dr. Kinsbourne explained, contains less of the pertussis toxin present in the DPT

vaccine (another pertussis vaccine formulation) but enough residual toxin to have the same

effects with lower frequency. Special Master Horner rejected this opinion as speculation. Id.

Special Master Horner explained that the Melchior study’s conclusions were based solely on

statistical observations, and that a difference in formulation between DPT and DTaP that

implicates vaccine safety makes it unreasonable to apply statistical observations from the DPT

vaccine to the DTaP vaccine. Id.

Special Master Horner gave minimal weight to the Bellman study as evidence that the

onset-age of infantile spasms may respond to vaccines for diphtheria and tetanus, including

DTaP, and not only DPT. Id. at 13. Unlike the Melchior study, the Bellman study tested a

stand-alone diphtheria and tetanus (“DT”) vaccine in addition to testing DPT. Id. The study

compared recipients of the DT and DPT vaccine to control subjects of the same age and found a

“small excess” in the number of cases of infantile spasms first observed within the seven days

after vaccination, and a corresponding deficit in the cases observed within the next three weeks.

Id. According to the Bellman study, “this suggests that, in some cases, immunization may

3

As examples, Special Master Horner cited Sharpe v. Secretary of HHS, No. 14-65V, 2018

WL 7625360, at *31-32 (Fed. Cl. Spec. Mstr. Nov. 5, 2018); Taylor v. Secretary of HHS, No.

05-1133V, 2012 WL 4829293, at *30 (Fed. Cl. Spec. Mstr. Sept. 20, 2012); Holmes v. Secretary

of HHS, No. 08-185V, 2011 WL 2600612, at *20 (Fed. Cl. Spec. Mstr. Apr. 26, 2011); Simon v.

Secretary of HHS, No. 05-941V, 2007 WL 1772062, at *7 (Fed. Cl. Spec. Mstr. June 1, 2007);

and Grace v. Secretary of HHS, No. 04-[redacted], 2006 WL 3499511, at *9 (Fed. Cl. Spec.

Mstr. Nov. 30, 2006).

5

trigger the onset of spasms or attract attention to symptoms in children destined to show the

condition overtly within a short time.” Bellman, supra, at 1031. The fact that these results

applied to the DT vaccine which, like DTaP and unlike DPT, did not contain whole-cell

pertussis, meant that these results could not be dismissed for the same reason that Special Master

Horner found the Melchior study’s observations inapplicable. Decision on Remand at 13.

This finding of the Bellman study, Special Master Horner noted, was limited. Most of

the study’s “small excess” of post-DT-vaccine cases were the kind of infantile spasms caused by

a known, pre-existing brain injury (“symptomatic”), unlike C.K.’s unexplained (“cryptogenic”)

infantile spasms. Id. (citing Bellman, supra, at 1033 tbl.III). Further, as the Bellman study’s

authors and the respondent’s expert both suggested, some of the study’s “small excess” of post-

DT cases may be attributable to recall bias. Id. (citing Tr. at 161-62).

Because of these limitations, Special Master Horner found that the Bellman study,

without more, was insufficient to establish by a preponderance of the evidence that the DTaP

vaccine “can” cause infantile spasms under the first prong of the Althen test. Id.

2. Petitioners’ Two-Hit Model of Infantile Spasms

Finding the evidence on which Special Master Millman had relied to be insufficient to

satisfy the Althen test’s preponderant-evidence standard, Special Master Horner then applied the

Althen test to the petitioners’ theory of causation that Special Master Millman had not reached in

her earlier decision. See Decision on Remand at 6, 14-20.

Dr. Kinsbourne had proposed a “two-hit” model of causation in which a stressful event

triggers infantile spasms in an already-susceptible individual. See id. at 15-16 (summarizing Dr.

Kinsbourne’s premises and scientific authorities). The model relies on various studies linking a

release of corticotropin-releasing hormone (“CRH”), a stress hormone, to infantile spasms and

identifying an immune response as a cause of CRH release. Id.

Based on this evidence, Special Master Horner found that infection could trigger an

immune response that could contribute to the onset of infantile spasms. Id. at 20. He found no

evidence, other than Dr. Kinsbourne’s ipse dixit, that vaccination—as opposed to infection—

could cause such a seizure-triggering immune response. Id. The cited studies, Special Master

Horner found, implicated infection, not vaccination, as a second “hit” in the “two-hit” model that

explained the onset of infantile spasms. See id. at 19-20.

The evidentiary gap between vaccination and a seizure-triggering immune response,

Special Master Horner found, had been raised at the entitlement hearing before Special Master

Millman. Id. at 17-18 (citing Tr. at 78). During the hearing, Special Master Millman asked Dr.

Kinsbourne directly if any of the submitted studies on which he relied specifically implicated

vaccination as the second “hit,” and Dr. Kinsbourne responded that he did not recall. Id.

Dr. Kinsbourne had tried to close the gap in the petitioners’ theory, explaining in his

expert report how the body’s immune response to vaccination could be the second (CRH-

producing and ultimately seizure-triggering) “hit.” Id. at 17 & n.34 (summarizing ECF 6 at 7).

6

Dr. Kinsbourne cited studies by Spinelli and Schmidt showing that an innate immune response

could trigger CRH production and release inflammation-causing cytokines. Id. Dr. Kinsbourne,

however, did not attribute discussion of vaccination as the cause of such an immune response to

either study. Rather, Dr. Kinsbourne maintained that vaccination necessarily causes an innate

immune response and thus could cause the same increase in CRH production that Spinelli and

Schmidt attribute in their study to an innate immune response caused by infection. See id. at 18

n.35.

Special Master Horner found that Dr. Kinsbourne’s attempt to implicate vaccination as a

possible second “hit” lacked support. “[Dr. Kinsbourne’s] insertion of vaccination as the ‘in

turn’ vehicle for activation of proinflammatory cytokines, which he intimates are sufficient to

bring about the cited findings by Spinelli and Schmidt, are his words alone.” Id.

Special Master Horner rejected Dr. Kinsbourne’s opinion that the findings in the Spinelli

and Schmidt study of increased CRH production were necessarily applicable to the immune

reaction caused by vaccination. Id. at 17 n.34. It was, Special Master Horner found, an

“untested opinion deep-seated in advanced immunology.” He noted that Dr. Kinsbourne was a

practicing neurologist, not an immunologist. Id. at 19. Moreover, Special Master Horner

provided multiple examples in which special masters had rejected similar reasoning. 4 Id. at 18

4

Special Master Horner quoted Inamdar v. Secretary of Health and Human Services, which

rejected reasoning similar to Dr. Kinsbourne’s when applied sensorineural hearing loss following

influenza vaccination:

the argument that cytokine upregulation can be a pathogenic

mechanism unsuccessfully attempts to leverage what is known

about how vaccines generally affect the immune system into proof

that these anticipated processes can also be pathogenic. To be sure,

components of this theory are based on reliable science. Petitioner

has referenced reliable literature establishing that certain

proinflammatory cytokines (including IL-6 and TNFalpha) have

been shown to be elevated following vaccine administration (see,

e.g., Christian at 1, 5), or that these same cytokines may play a role

in the process of hearing loss (Kuemmerle-Deschner, Pathak). But

the theory lacks similar support for its connecting proposition –

that the cytokine upregulation leads to or causes hearing loss – as

well as the concept that vaccination can instigate the entire disease

process. It is not enough to note that increased numbers of

inflammatory-associated cytokines have been measured in the

context of certain injuries or illnesses (or are involved in the body's

reaction to those illnesses). Dr. Axelrod does not personally have

demonstrated expertise studying these unsupported elements of the

7

n.35. Special Master Horner explained, “[I]t cannot be enough for Dr. Kinsbourne to merely

highlight cytokine production by innate immunity as a process that does occur and thereby claim

it to be necessarily injurious.” Id. Although Dr. Kinsbourne’s report otherwise made use of

scientifically reasonable propositions, the part of Dr. Kinsbourne’s report implicating the body’s

immune response to vaccination as the CRH-related “second hit” that could cause an earlier

theory, and no persuasive or reliable literature was offered on such

points.

No. 15-1173V, 2019 WL 1160341, at *17 (Fed. Cl. Spec. Mstr. Feb. 8, 2019). Special Master

Horner further cited three other decisions rejecting this reasoning:

Bender v. Sec’y of Health & Human Servs., 141 Fed. Cl. 262, 266

(2019) (denying a motion for review where “[t]he Special Master

found that Dr. Byers cited no evidence to explain how the mere

presence of cytokines could instigate an autoimmune process that

results in a demyelinating condition in the central nervous system

(“CNS”), particularly when the vaccines were injected in the

periphery.”); McKown v. Sec’y of Health & Human Servs., No. 15-

1451V, 2019 WL 4072113, at *50 (Fed. Cl. Spec. Mstr. July 15,

2019) (finding with regard to eczema that “[t]he fact that cytokine

upregulation is promoted by vaccination – a medically reliable

assertion standing alone – does not mean that this cytokine increase

is definitionally harmful, especially given (as observed by Dr.

MacGinnitie) that it is difficult to establish whether certain

proinflammatory cytokines are instigators or merely mediators of a

disease process begun in some other way.”); Palattao v. Sec’y of

Health Human Servs., No. 13-591V, 2019 WL 989380, *36 (Fed.

Cl. Spec. Mstr. Feb. 4, 2019) (explaining that “[p]etitioners argued

that the immunologic stimulation that vaccinations generally

provide (which inherently encourage cytokine production) could

result in a demyelinating condition like TM. Petitioners’ theory was

rooted in the general proposition that virtually any vaccine could be

pathogenic and result in TM. See Tr. at 160. But they have offered

insufficient reliable scientific or medical evidence that addresses the

specific pathogenicity of the vaccines in dispute herein, nor anything

connecting vaccines to TM based merely on their recognized pro-

inflammatory capacities.”).

Decision on Remand at 18 n.35.

8

onset of infantile spasms was an “attempt[ ] to stitch together disparate areas of investigation in

the field of immunology based only on his own say-so.” Id. at 17 n.34.

Based on this record, Special Master Horner found that the only support in the record for

the proposition that the DTaP vaccine could be the beginning of a second “hit,” or an

“inflammation and stress response leading to seizure,” was the Bellman study. Id. at 18.

The respondent’s expert argued that fever, not vaccination itself, lowers the seizure

threshold. See id. at 16. Accordingly, Special Master Horner accepted the theory that “vaccines

can in some contexts contribute to seizures as part of a larger immune/inflammatory process,

namely where . . . the vaccine causes a seizure threshold-reducing fever and thereby results in

febrile seizures.” Id. at 20. Special Master Horner did “not find preponderant evidence on this

record that the DTaP vaccine itself can cause seizures.” Id.

3. Althen’s Second Prong

Next, Special Master Horner applied this narrow theory of how the DTaP vaccine “can”

cause infantile spasms to the facts of C.K.’s case in order to determine whether C.K.’s

vaccination “did” cause her first observed seizure. 5 See Decision on Remand at 21-25.

Special Master Horner noted that Dr. Kinsbourne’s application of his theory to the facts

of C.K.’s case was based “exclusively” on the short amount of time—ten hours—between C.K.’s

vaccination and the first-observed seizure. Id. at 21. Dr. Kinsbourne testified:

It is reasonable to suppose that when the onset of the seizure disorder

is within hours of a vaccination that the – and when the vaccination

is known to produce proinflammatory cytokines, which are known

to have an excitatory or even repligenic property that the–that

property of the cytokines was involved in the onset of the seizure

disorder.

Id. (quoting Tr. at 73).

Relying on Federal Circuit precedent, Special Master Horner rejected this “mere

suspicion of a temporal relationship” as insufficient to establish causation for C.K.’s off-table

injury. Decision on Remand at 22. He explained that “‘[w]hen a petitioner relies upon proof of

causation in fact rather than proof of a Table Injury, a proximate temporal association alone does

not suffice to show a causal link between the vaccination and the injury . . . A reputable medical

5

Special Master Horner explained that infantile spasms, as a condition, consist of two

elements: epilepsy (the condition of having seizures) and an encephalopathy (brain injury or

infection). Finding that the petitioners had not argued that the DTaP vaccine somehow caused

the encephalopathic element of C.K.’s infantile spasms, Special Master Horner narrowed the

issue to whether DTaP caused both C.K.’s first seizure and thus the early onset of C.K.’s

infantile spasms condition. See Decision on Remand at 14.

9

or scientific explanation must support this logical sequence of cause and effect.’” Id. (citing

Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (ellipsis in

original).

Special Master Horner rejected the effectiveness of ACTH in treating C.K.’s seizures as

having case-dispositive evidentiary value. See id. at 22. He explained that even if he had

accepted the effectiveness of C.K.’s ACTH treatments “as some limited evidence that C.K.’s

initial seizures were triggered or mediated by a stress hormone,” that conclusion “relates only to

the broadest aspect of Dr. Kinsbourne’s theory and, without more, does not implicate C.K.’s

vaccination(s) as a relevant stress event.” Id.

Special Master Horner found no other evidence in the record, including in the findings of

C.K.’s treating physicians, that a vaccine caused C.K.’s infantile spasms. Id. at 22-23. Dr.

Kinsbourne “suggested that evidence of inflammation, such as MRI findings or fever, would be

expected if excessive or abnormal cytokine inflammation were the cause of C.K.’s condition.”

Id. at 22 (citing Tr. at 173-75). Dr. Kinsbourne also testified that fever is “‘by far the most

powerful component of the immune response that’s related to a decrease in seizure threshold.”

Id. (quoting Tr. at 140.) Dr. Kinsbourne confirmed that there is no such evidence in C.K.’s

records, explaining that it is “‘not a routine investigation that’s usually done.’” Id. (quoting Tr.

at 99-100). Special Master Horner further noted that the petitioners had reported to C.K.’s

treating physician that she did not have a fever during her first seizure, and there was no other

evidence of seizure-triggering fever or other inflammation in the relevant records. Id.

Special Master Horner rejected Dr. Kinsbourne’s opinion that the cytokine reaction he

proposed would not necessarily manifest beyond the seizures themselves. Id. (citing Tr. at 99-

100). Special Master Horner noted that fever was present in the case in which Dr. Kinsbourne’s

theory had been accepted. Id. at 23 (citing Fuller v. Sec’y of Health & Human Servs., No. 15-

1470V, 2019 WL 7576382 (Fed. Cl. Spec. Mstr. Dec. 17, 2019). Additionally, Special Master

Horner explained that accepting the seizures—the effect—as the only evidence of underlying

inflammation that caused the seizures was circular logic. Id.

Special Master Horner rejected Dr. Kinsbourne’s further contention that without the

vaccines, C.K. might have safely exited the age-related window for the onset of infantile spasms,

and that it was “speculation” to conclude otherwise. See id. at 24. Special Master Horner noted

that Dr. Kinsbourne’s own report concluded that the question of whether C.K. could have exited

the age-window without an onset of infantile spasms was unanswerable. Id. (citing Ex. 6 at 6,

filed on compact disc as ECF 19). Yet Dr. Kinsbourne purported to shift the burden by

answering the question and labeling the other side’s answer “speculation.” See id. The

petitioners, Special Master Horner reminded, had the burden to show a logical sequence of cause

and effect demonstrating that the vaccine caused C.K.’s infantile spasms. Id. He concluded that

the petitioners had failed to do so under Althen’s second prong, and accordingly had failed to

prove causation. Id. at 24-25.

The petitioners moved for review of Special Master Horner’s decision, (ECF 140), and

the motion is fully briefed. (ECF 140, 143.) The Court decides the motion without hearing oral

argument, which, the Court finds, would not aid in resolving the motion.

10

II. ANALYSIS

Under the Vaccine Act, this Court reviews a special master’s vaccine compensation

decision to determine if it is “‘arbitrary, capricious, an abuse of discretion, or otherwise not in

accordance with law.’” Althen, 418 F.3d at 1277 (quoting 42 U.S.C. § 300aa–12(e)(2)(B)).

More specifically, the Court considers a special master’s interpretation of statutes and other legal

rules anew, without deference to the special master. Hines on Behalf of Sevier v. Sec’y of Dep’t

of HHS, 940 F.2d 1518, 1528 (Fed. Cir. 1991). The Court defers, however, to the special

master’s factual findings so long as the special master has (1) “considered the relevant evidence

of record,” (2) “drawn plausible inferences,” and (3) “articulated a rational basis for the

decision.” Id.

Under the arbitrary and capricious standard, the Court does not “reweigh” or re-evaluate

the probative value of the evidence or a witness’s credibility. Porter v. Sec’y of HHS, 663 F.3d

1242, 1249 (Fed. Cir. 2011). The Federal Circuit has explained:

Congress assigned to a group of specialists, the Special Masters

within the Court of Federal Claims, the unenviable job of sorting

through these painful cases and, based upon their accumulated

expertise in the field, judging the merits of the individual claims.

The statute makes clear that, on review, the Court of Federal Claims

is not to second guess the Special Masters [sic] fact-intensive

conclusions; the standard of review is uniquely deferential for what

is essentially a judicial process. Our cases make clear that, on our

review . . . we remain equally deferential. That level of deference is

especially apt in a case in which the medical evidence of causation

is in dispute.

Deribeaux ex rel. Deribeaux v. Sec’y of HHS, 717 F.3d at 1366-67 (Fed. Cir. 2003) (quoting

Hodges v. Sec’y of HHS, 9 F.3d 958, 961 (Fed. Cir. 1993) (modification in original).

The petitioners argue that the special master erred by dismissing key “facts.” (ECF 140

at 1.) The petitioners conclude that their explanation and evidence are well-established, and that

the respondent’s rejection of their theory amounts to the assertion of an idiopathic cause,

grounded completely in speculation, for C.K.’s infantile spasms. The special master’s decision

to credit the respondents’ arguments, the petitioners argue, is therefore arbitrary and capricious.

The Court finds that the petitioners’ arguments were either waived or fail to address the

dispositive parts of Special Master Horner’s reasoning. Accordingly, the petitioners fail to show

that Special Master Horner’s decision on remand is arbitrary or capricious.

A. Waiver

The petitioners argue that it was arbitrary and capricious for Special Master Horner to

dismiss the stress effects of C.K. having received four vaccinations. Vaccine Rule 8(f)(1) of the

Rules of the Court of Federal Claims provides that “[a]ny fact or argument not raised specifically

in the record before the special master will be considered waived and cannot be raised by either

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party in proceedings on review of a special master’s decision.” The petitioners’ motion fails to

develop this argument further, and they offer no explanation or citation of when or how the

argument was raised before the special master. Accordingly, this argument is waived.

B. Implications of Rapid Onset

The petitioners argue, in passing, that the onset, within 10 hours of the receipt of the

vaccination, of infantile spasms in the otherwise healthy, four-month-old C.K. distinguishes her

case from those involving idiopathic, genetically-caused infantile spasms that manifest over

several months. This rapid onset, the petitioners argue, means that C.K.’s infantile spasms must

have had some other cause.

Special Master Horner addressed a similar argument regarding whether C.K. might have

still developed infantile spasms without vaccination. Decision on Remand at 24. The special

master did not reject the notion that C.K.’s infantile spasms might have had a non-genetic cause.

Indeed, in his analysis of the petitioners’ causal theory, Special Master Horner accepted that an

inflammatory immune response triggered by infection can cause infantile spasms. Id. at 20.

Special Master Horner rejected as insufficient the petitioners’ evidence that C.K.’s DTaP vaccine

caused a non-genetic, inflammatory immune response that the petitioners established could affect

the onset of infantile spasms. The petitioners provide no rationale grounded in the record to

support a conclusion that this finding of the special master is arbitrary or capricious.

C. Whether DTaP Causes Seizures

The petitioners argue that their evidence satisfies the Althen test’s first prong because it is

“well-accepted” that the DTaP vaccine causes seizures, albeit to a lesser extent than the DPT

vaccine. It was arbitrary and capricious, they argue, for Special Master Horner to “hold that less

adverse effects is none.” (ECF 140 at 6.) The petitioners further argue that attenuated pertussis

is a neuro-toxin. They argue that medical professionals agree that DTaP can cause the same

neurological damage as DPT, but only about one-third as frequently. As a result, the DTaP

vaccine can cause seizure-like disorders. They urge the Court to take judicial notice of the DTaP

vaccine’s labeling and additional studies that they first raised in their motion to supplement the

record, which Special Master Horner denied. 6

Special Master Horner held neither that the DTaP vaccine cannot cause seizures nor that

the DTaP vaccine has no adverse effects. Instead, Special Master Horner found that the

petitioners had failed to meet their burden with record evidence to establish that the DTaP

vaccine can cause the onset of infantile spasms. In reaching that conclusion, the special master

rejected the Melchior study as inapplicable because its findings on the effect of the DPT vaccine

were statistical observations. He refused to use statistical observations of one vaccine’s effects

to extrapolate data on the effects of another vaccine that was designed to have significantly

6

The petitioners make no argument that Special Master Horner’s legal conclusions in his

decision denying their motion to supplement the record were erroneous.

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different (and safer) effects. This conclusion is reasonable and supported by precedent, which

Special Master Horner cited.

The petitioners argue that the precedents Special Master Horner cited support their

contention that the DTaP vaccine can cause seizures, albeit less often than the DPT vaccine does.

The petitioners’ argument quotes language from these precedents out of context and misses the

point. The opinions Special Master Horner cited uniformly refuse to extrapolate statistical,

immunological data from one context to a different context. Most of the cases cited dealt with

the DPT and DTaP vaccines. The one decision that the petitioners criticize as not related to DPT

and DTaP in fact calls out Dr. Kinsbourne for misapplying studies of children and infants to

adolescents. See Holmes v. Sec’y of HHS, No. 08-185V, 2011 WL 2600612, at *20 (Fed. Cl.

Spec. Mstr. Apr. 26, 2011) (“Doctor Kinsbourne has been criticized in the past for extrapolating

from studies of the DPT vaccine to the DTaP vaccine. Here, he extrapolated from studies of

infants and young children, whom he acknowledged have brains that are very different from

older children and adolescents, to apply their findings and conclusions to a seizure disorder in an

adolescent.”)

The petitioners further argue that the DTaP vaccine’s ability to cause seizures is so well-

accepted that the Court should take judicial notice of this fact. The respondent’s failure to

provide evidence that DTaP “does no harm,” the petitioners argue, means that the respondent’s

defense, not the petitioners’ theory, is based on speculation and an expert’s ipse dixit.

This argument asserts a presumption that findings as to the safety of the DPT vaccine

create a presumption that all pertussis-containing vaccines are injurious. From this premise, the

petitioners go on to argue that the respondent had a burden to prove that the DTaP vaccine is not

injurious. The Court is unaware of any authority to support such a presumption for an injury not

listed in HHS’s vaccine injury table. Indeed, as Special Master Horner noted, “[t]he burden is on

the petitioner to introduce evidence demonstrating that the vaccination actually caused the injury

in question.” Decision on Remand at 5 (citing Althen, 418 F.3d at 1278). The petitioners’ effort

to shift the burden of proof is inconsistent with the law, and the Court rejects it.

Special Master Horner considered whether there was evidence that the DTaP vaccine,

specifically, could cause infantile spasms and found nothing other than the Bellman study, which

he found insufficient because the majority of the cases of infantile spasms it identified were

symptomatic, unlike the cases at issue here, and the study’s own authors suggested that the

finding may have been attributable to recall bias. These are rational reasons for assigning little

probative weight to the Bellman study, and this Court lacks authority otherwise to reweigh this

evidence. Porter, 663 F.3d at 1249.

The petitioners’ argument that the Court should take judicial notice of a seizure warning

on the DTaP vaccine’s packaging and judicial notice of a “Federal Circuit” decision that, itself,

took judicial notice of the DTaP packaging warning is flawed. First, judicial notice cannot serve

as “a remedy for a party's failure to introduce readily available evidence of crucial facts” before

the special master. Rodriguez v. Sec’y of Health & Human Servs., 91 Fed. Cl. 453, 461 (2010),

aff’d, 632 F.3d 1381 (Fed. Cir. 2011). The petitioners do not assert that the DTaP packaging was

unavailable when they litigated their theory of causation before the special master.

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Further, the “Federal Circuit” decision that the petitioners refer to is in fact a decision of

this court. (See ECF 140 at 10 (“The Federal Circuit in Loving v. Secretary, 86 Fed. Cl. 135,

146-147 (Fed. Cl. [sic.] 2009) cited to several manufacturers’ DTaP package inserts.”) (italics in

original).)

The Loving decision’s use of judicial notice is distinguishable. In Loving, Judge Lettow

of this court took notice of the “two to three days” timeframe listed on the DTaP vaccine’s

packaging to support the proposition that “adverse reaction to the vaccination typically will

occur within three days of receiving the vaccine.” Id. This part of the Loving decision was not

evaluating whether the petitioners in that case established preponderant evidence of a causal

theory under Althen’s first prong. Rather, the Loving decision was analyzing the temporal

proximity between vaccination and injury under Althen’s third prong. See id. at 145 (“Here, the

special master failed to examine the record in its entirety when he determined that the petitioners

could not satisfy the temporal-relationship prong of Althen.”). Further, Judge Lettow in Loving

did not rely on judicial notice alone to support his conclusion that the petitioners satisfied

Althen’s third prong. After taking judicial notice of the packaging, the decision proceeded to

describe evidence submitted by the respondents that supported the same proposition. Id. at 148.

In this case, the Court will not take judicial notice of the DTaP packaging or other

materials that could have been, but were not, submitted to the special master in the first instance.

D. Rejection of the Double-Hit Theory

The petitioners’ motion argues that the effectiveness of ACTH in controlling C.K.’s

seizures was sufficient evidence that C.K.’s seizures were caused by the stress hormone CRH.

The petitioners further argue that the rapid onset of the seizures implicates an innate immune

reaction as the CRH-producing cause.

These arguments fail to address Special Master Horner’s reasoned explanation as to why

he did not find the effectiveness of ACTH in treating C.K.’s seizures dispositive. ACTH’s

effectiveness in C.K.’s case, at most, suggests that her seizures were triggered by CRH. It does

not implicate vaccination as the cause of a seizure-triggering CRH release.

Similarly, identifying C.K.’s seizure with the rapidity of an innate immune response, at

most, suggests that an immune response caused an increase in C.K.’s levels of CRH. Neither it

nor any other evidence in the record show by preponderant evidence that vaccination can cause

such an innate immune response.

The petitioners claim that the Iwasaki and Medzhitov article submitted with Dr.

Kinsbourne’s report “directly implicate[s] vaccinations as starting the seizure response in issue.”

(ECF 140 at 5.) The petitioners’ motion fails, however, to provide a quote or any explanation of

how the cited article implicates vaccinations in the manner proffered by the petitioners. The

sentence in the petitioners’ brief is followed by an unidentified block quote of Dr. Kinsbourne’s

own words in his report, not the Iwasaki and Medzhitov article. (Compare ECF 140 at 5 with

Ex. 6-1 at 7, filed on compact disc as ECF 19.) The petitioners also fail to identify where and in

what manner Iwasaki and Medzhitov’s “direct[ ] implic[ation]” of vaccination was raised before

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Special Master Horner. (See Ex. 6-1 at 7.) The Court finds no substance to this unelaborated

assertion of authority. To the degree there might be any substance, the Court finds that the

petitioners waived the argument.

III. CONCLUSION

For the foregoing reasons, the Court DENIES the petitioners’ motion for review and

SUSTAINS the special master’s decision on remand. The clerk shall enter judgment

accordingly.

It is so ORDERED.

s/ Richard A. Hertling

Richard A. Hertling

Judge

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